WO2021111315A1

WO2021111315A1 - A non-invasive ventilation device for patients with chronic obstructive pulmonary disease

Info

Publication number: WO2021111315A1
Application number: PCT/IB2020/061360
Authority: WO
Inventors: Karan BHATT; Avijit BANSAL; Vijay HADDA; Parigi Vedanti Madhusudhan RAO
Original assignee: The Secretary, Department Of Biotechnology
Priority date: 2019-12-03
Filing date: 2020-12-02
Publication date: 2021-06-10

Abstract

Embodiments disclose a system, a method and an interface device for non-invasive ventilation, NIV, to a patient, and adapted to fit human faces having different facial geometries, characterized in that, the interface device comprises: a mask comprising: a casing adapted to form an enclosure around oral and nasal cavities of a patient; a plurality of bottom straps fixed to a bottom strap mount located at the bottom portion of the casing and a plurality of top straps fixed to a top strap mount located atop the casing; and a silicon liner or cushion adapted to fit the casing of the mask, said liner or cushion being adapted to comfortably fit facial skin of a patient, and reduce leakage of breathing gas, using Bilevel Positive Airway Pressure, BiPAP mechanism, wherein under higher positive air pressure, the liner is adapted to inflate and under lower positive air pressure, the liner is adapted to deflate.

Description

A NON-INVASIVE VENTILATION DEVICE FOR PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

TECHNICAL FIELD OF THE INVENTION

The present subject matter described herein in general relates to non- invasive ventilation device such as respiratory masks, particularly to a device to provide ventilation non-invasively to persons with acute exacerbation of chronic obstructive pulmonary disease.

BACKGROUND OF THE INVENTION

Progressive lung diseases such as emphysema, chronic bronchitis, and refractory (non-reversible) asthma that are characterized by increasing breathlessness are termed as Chronic Obstructive Pulmonary Disease, COPD. An acute exacerbation of chronic obstructive pulmonary disease, AECOPD, is a clinical diagnosis made when a patient with COPD experiences a sustained increase in cough, sputum production, and/or dyspnea. It has been observed that 90 percent deaths out of total worldwide deaths due to AECOPD are recorded in low and middle income countries. Episodes of AECOPD are most common cause of death in COPD.

Non-invasive ventilation, NIV, is the first line of treatment for AECOPD as recommended by the American Thoracic Society, ATS, and European Respiratory Society, ERS. This is primarily because NIV has fewer complications as opposed to invasive treatments like Endotracheal intubation.

Most common device for NIV solution is an Oro-nasal mask as shown in figure 1. It is basically an interface for gas circulation that is introduced into the Oro-nasal cavity externally and is held by straps that wrap around the head or neck area of the patient.

However, such Oro-nasal mask fails to provide the desired effect. The major reason of such NIV methods and devices is leakage of gas. Such leakage in gas may be prevented by tightening the mask or the device. When leakage is found using a typical mask, the force on the entire mask (e.g., by way of a strap) is typically increased until leaks are reduced to an acceptable level or eliminated. With such additional force exerts unnecessarily higher forces at some locations, which can cause discomfort and/or injury. The tightening of interface causes pressure ulcers on face as well.

In regard of the same, reference is made to US20170239437A1 that discloses a customizable respiratory mask comprising a frame having a perimeter and a conduit connection, a conforming seal positioned along the perimeter of the frame. The conforming seal in turn includes a sealing surface and a connecting surface, the connecting surface configured to mate with the perimeter of the frame, and the sealing surface configured to conform to a users' face. The frame portion and the seal portion are configured to transition from a decreased stiffness state and an increased stiffness state. However, such adjustments do not conform to the different face profile of different people.

Another reference is made to EP2603269B 1 that discloses patient interface device including a dynamic self-adjustment mechanism. It is disclosed therein that the grooved adjustment mechanism includes the grooved adjustment mechanism and in that the stiffness increase from the first side of the main body to the second side of the main body. Such heavy masks firstly do not take into account the different facial geometries of different people and secondly such complex structures on face increases the discomfort of the patient wearing them. In view of the prior art disclosed hitherto, there is a dire need of a device or an interface for efficiently providing ventilation non-invasively with as minimal gas leakages as possible causing no pressure injuries on the face of the user.

SUMMARY OF THE INVENTION

The following disclosure presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the present invention. It is not intended to identify the key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concept of the invention in a simplified form as a prelude to a more detailed description of the invention presented later.

An object of the present invention is to provide a non-invasive ventilation device for patients with chronic obstructive pulmonary disease that overcomes the drawbacks of the prior art solutions.

Another object of the present invention is to provide a device or an interface for non-invasive ventilation to increase the overall efficiency of the ventilation remedy for people having obstructive pulmonary diseases. Yet another object of the present invention is to provide a device for non- invasive ventilation in people suffering from obstructive pulmonary disease with desired efficacy of the NIV.

A further object of the present invention is to provide a device for efficient non-invasive ventilation in people having exacerbation of chronic obstructive pulmonary disease to prevent them to be intubated to increase mortality rate.

An aspect of the present invention is an interface device for non-invasive ventilation, NIV, to a patient, and adapted to fit human faces having different facial geometries, characterized in that, the interface device comprises: a mask comprising: a casing adapted to form an enclosure around oral and nasal cavities of a patient; a silicon liner or cushion adapted to fit the casing of the mask, said liner or cushion being adapted to comfortably fit facial skin of a patient, and reduce leakage of breathing gas, using Bilevel Positive Airway Pressure, BiPAP mechanism, wherein under higher positive air pressure, the liner is adapted to inflate and under lower positive air pressure, the liner is adapted to deflate.

According to an embodiment, the interface device comprises: a plurality of bottom straps fixed to a bottom strap mount located at the bottom portion of the casing and a plurality of top straps fixed to a top strap mount located atop the casing.

According to an embodiment, the interface device comprises: an intermediate attachment adapted to fit the silicon liner or cushion on one side and coupled to an interface shell on the other side, wherein the interface shell comprises: an inflatable air bladder within the interface shell, wherein cyclic inflation and deflation of air bladder increases and decreases interface pressure on the patient’s face; an interface elbow adapted to attach a NIV pipe for ventilation, wherein the interface elbow can be moved in any direction; and an exhalation port. External air supply from a NIV/extemal device inflates and deflates the air bladder by filling air in and out through an inflatable air bladder inlet

According to an embodiment, the interface device comprises: a forehead support fixed to the interface shell via a flexible joint, facilitating in distributing pressure to the forehead from nasal bridge and adapted to couple the plurality of top straps fixed to a top strap mount located on it; and a forehead cushion at the end of the forehead support for proper support and comfort on the face of the patient.

According to an embodiment, the silicon liner or cushion is a hollow, inflatable liner or cushion and comprises a sticky patch and a casing line to adjust the sealing surface according to facial profile by stretching the cross section of liner at a particular location.

According to an embodiment, the interface device comprises: a plurality of profile adjusters on the casing of the mask; and at least two holes in the casing of the mask for inhale of oxygen and exhale of the air containing carbon dioxide; wherein the plurality of profile adjusters is adapted to change the profile of the silicon liner or cushion, at determined sections, according to facial geometry of the patient.

According to an embodiment, high-pressure air builds up in the mask consequent to inhalation of air and the mask becomes tighter facilitating low leakage as the silicon liner inflates, and during exhalation, the pressure of air in the mask is low facilitating loosening of the mask as the silicon liner deflates.

According to an embodiment, the inflation and deflation of the silicon liner or cushion is done separately by a pump and an actuator, wherein the ratio of inflation and deflation can be set according to requirement which is specific to the user.

Another aspect of the present invention is a non-invasive ventilation, NIV method for patients, by an interface device adapted to fit human faces having different facial geometries.

Another aspect of the present invention is a non-invasive ventilation, NIV system for patients, comprises an interface device adapted to fit human faces having different facial geometries.

Other salient features and advantages of the invention will become apparent to those skilled in the art from the following detailed description, which, taken in conjunction with the annexed drawings, discloses exemplary embodiments of the invention.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS The above and other aspects, features, and advantages of certain exemplary embodiments of the present invention will be more apparent from the following description taken in conjunction with the accompanying drawings in which:

Figure 1 illustrates an exemplary embodiment of the most common NIV interface known in the art.

Figure 2A illustrates the inner and outer view of the nasal interface showing the inflatable liner of the interface and the position of the same on the face of the user.

Figures 2B-2E illustrate a side view, a lateral view, a front view and a rear view of an interface device for non-invasive ventilation, NIV, to a patient, and adapted to fit human faces having different facial geometries, according to an embodiment of the present invention.

Figure 3 illustrates the different views of an interface device for non- invasive ventilation, NIV, to a patient, and adapted to fit human faces having different facial geometries, according to an embodiment of the present invention.

Figure 4 illustrates the profile adjuster on an interface device for non- invasive ventilation, NIV, to a patient, and adapted to fit human faces having different facial geometries, according to an embodiment of the present invention.

Figure 5 illustrates the Ventilation procedure according to an embodiment of the present invention.

Figure 6 illustrates the different parts and sectional view of an interface device for non-invasive ventilation, NIV, to a patient, and adapted to fit human faces having different facial geometries, according to an embodiment of the present invention.

Figure 7 illustrates the setting up of an interface device for non-invasive ventilation, NIV, on a user’s face according to an embodiment of the present invention.

Figures 8A-8D illustrate 3-Dimensional views of a prototype of an interface device for non-invasive ventilation, NIV, to a patient, and adapted to fit human faces having different facial geometries, according to an embodiment of the present invention.

Persons skilled in the art will appreciate that elements in the figures are illustrated for simplicity and clarity and may have not been drawn to scale. For example, the dimensions of some of the elements in the figure may be exaggerated relative to other elements to help to improve understanding of various exemplary embodiments of the present disclosure. Throughout the drawings, it should be noted that like reference numbers are used to depict the same or similar elements, features, and structures.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

The following description with reference to the accompanying drawings is provided to assist in a comprehensive understanding of exemplary embodiments of the invention. It includes various specific details to assist in that understanding but these are to be regarded as merely exemplary.

Accordingly, a person skilled in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope of the invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness.

The terms and words used in the following description are not limited to the bibliographical meanings, but, are merely used by the inventor to enable a clear and consistent understanding of the invention. Accordingly, it should be apparent to those skilled in the art that the following description of exemplary embodiments of the present invention are provided for illustration purpose only and not for the purpose of limiting the invention as defined by their equivalents.

It is to be understood that the singular forms “a”, “an,” and “the” include plural referents unless the context clearly dictates otherwise.

Features that are described and/or illustrated with respect to one embodiment may be used in the same way or in a similar way in one or more other embodiments and/or in combination with or instead of the features of the other embodiments.

It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

The existing oro-nasal masks more or less have leakages and it is a major concern for doctors. Different facial geometry of every patient is the reason behind it and tightening of mask is required to reduce leakage under the application of positive air pressure. Also, most of hospitals used to purchase only medium size mask and it is not compatible with all face sizes. Due to lack of ready availability of masks for different facial geometries, patients wear masks which do not exactly fit their facial geometric profile. Uneven pressure distribution for the heterogenous face profile of patients and the fixed interface profile of the existing masks with the face of the patients, can lead to pressure ulcers on bony parts of a face of a patient.

Embodiments of the present invention provide an interface device for non- invasive ventilation to people having different facial geometries, with acute exacerbation of chronic obstructive pulmonary disease. The interface device comprises a mask which comprises a casing adapted to form an enclosure around oral and nasal cavities of a patient. The device further comprises a plurality of bottom straps fixed to a bottom strap mount located at the bottom portion of the casing and a plurality of top straps fixed to a top strap mount located atop the casing. A hollow, silicon liner or cushion is adapted to fit the casing of the mask, which provides comfortable fitting to the facial skin of a patient, and also reduces leakage of breathing gas, using Bilevel Positive Airway Pressure, BiPAP mechanism, wherein under higher positive air pressure, the liner is adapted to inflate and under lower positive air pressure, the liner is adapted to deflate.

In an embodiment of the present invention is provided an interface to provide ventilation non-invasively to the patient with acute exacerbation of chronic obstructive pulmonary disease. It comprises a hollow silicon liner or cushion. The liner or cushion is adapted to touch with the facial skin and air passes through the liner. Figure 2A shows the inner and outer view of the nasal interface device showing the inflatable liner (silicon liner or cushion) of the interface and the position of the same on the face of the user and the position of the mask on the face of the user. The interface device is ergonomic in design, keeping into account the comfort of the user and reduce leakage of oxygen. The various parts and sections of the interface device according to an embodiment of the invention are seen in Figure 6.

An embodiment as shown in Figures 2B-2E, illustrate an interface device having an inflatable air bladder (8) in an interface shell (4). The external air supply from NIV/external device inflates and deflates air bladder (8) by filling air in and out through an inflatable air bladder inlet (3). This cyclic inflation and deflation of air bladder (8) increases and decreases interface pressure on patient’s face. The interface comprises of a silicon liner or cushion (1) fitted to an intermediate attachment (2). The intermediate attachment (2) has two sides, one to fix the cushion (1) and another to be fixed in interface shell (4). The interface shell (4) comprises of an interface elbow (5), which can be moved in any direction. The interface elbow (5) is adapted to attach a NIV pipe for ventilation. The interface elbow (5) also has an exhalation port (6), which can be a simple silicon flap or a specially designed hepa filter can be fixed on it. A forehead support (10) fixed to interface shell (4) via a flexible joint (9) facilitates in distributing pressure to the forehead from nasal bridge. Forehead cushion (12) at the end of forehead support (10) made of silicon or similar biocompatible material gives proper support and comfort on the face of the patient. Bottom strap mount (7) is used to fix bottom strap (14) on interface shell (4) and top strap mount (11) is used to fix top strap (13) on forehead support (10). The NIV supply pipe will be connected to the interface elbow (5) like an existing oro-nasal mask only.

In an embodiment, the silicon liner or cushion (1) is replaceable. Multiple sized liners or cushions can be attached to an intermediate attachment (2) which is an integral part of the interface shell (4).

In an embodiment, interface shell (4), inflatable air bladder (8), intermediate attachment (2) and silicon cushion (1) all combined make an interface. Out of which the shell and inflatable air bladder will be the same for a specified number of patients, intermediate attachment will be available in three sizes which can be changed according to cushion and cushion will be replaced for every patient which is also available in three sizes.

In simplified terms, for patient A, a medium size cushion is used in the interface. For patient B, if medium size cushion is needed then only cushion will be replaced but if for patient B, large/small size cushion is needed, then intermediate attachment will also be changed as per the cushion.

The interface is having a casing (with inbuilt inflatable air bladder) and three intermediate attachments. They can be used until specified patient limit. Only the cushion will be changed per patient. The intermediate attachment's purpose is to attach different cushions to one universal shell.

The intermediate attachment facilitates profile adjustment mechanism which modifies the profile of silicon cushion only to fit on the patient's face as uniformly as possible.

In the embodiments, as shown in Figure 2B, the silicon liner or cushion is a regular use and throw cushion without any hollow section.

In an embodiment, Figure 3 shows the interface device for non-invasive ventilation, NIV, (oro-nasal mask) comprising a connector via which the means to oxygen supply (33) is connected. Below the oxygen supply (33) is the chin section (36) of the mask of the interface device that continues as the hollow silicon liner (31). Above the connector that connects the oxygen supply and the interface device is a nebulization port (34) for administration of medications while breathing. The interface device is held to the face of the user by means of straps (35) that hold the mask of the interface device firmly yet comfortably to the face of the user. The hollow silicon liner (31) includes a sticky patch (37) and a casing line (38) to adjust the sealing surface according to facial profile by stretching the cross section of liner at a particular location. To accommodate different face sizes, customization of mask profile can be done by some kind of predetermined mechanism or some kind of accessories also.

In an embodiment, Figure 4 shows at least one profile adjuster of the interface device. It includes an adjustable silicon liner, and the nose section of the silicon liner is shown in the figure. The casing of the interface device comprises at least two holes for inhale of oxygen and exhale of the air containing carbon dioxide. In a further embodiment, the mask of the interface device comprises a plurality of profile adjusters placed on the casing having semi-circular projections. The casing further comprises extra groove to fit the liner for users having smaller face size. The casing of the mask of the interface device is re-usable i.e. only liners have to be changed and casing will he one time purchase until it breaks. Bilevel Positive Airway Pressure (BiPAP) mechanism has higher positive and lower positive air pressures and under higher positive air pressure, the liner (61) is adapted to inflate and under lower positive air pressure, it is adapted to deflate. As shown in Figure 6, the interface further comprises a casing. The casing is a transparent casing (62) that is adapted to seal oral and nasal cavities similar to the existing oro-nasal masks to prevent air leakage to atmosphere. There are rubber strips (67) in the interface that are adapted to hold the mask of the interface device comfortably on the face of a user. The interface further comprises a plurality of profile adjusters (64). It is this profile adjuster that will change the profile of the liner according to facial geometry of the user.

Figure 5 and also a section of figure 4 show the BiPAP mechanism or the ventilation procedure of the present invention in a flow diagram. The high- pressure air builds up in the mask of the interface device is consequent to inhalation of air. During inhalation, the mask becomes tighter thereby bringing low leakage as the liner inflates. During exhalation, the pressure of air in the mask is low. During exhalation, the mask loosens as the liner deflates.

Higher pressure air will pass through silicon liner of the device and given to the patient for ventilation. This higher pressure air will inflate the silicon liner which tighten the mask and seal it on face to reduce leakages. This inflated liner will deflate under lower air pressure and mask will be loosening up. This reduces pressure on face of patient which will reduce chances of pressure ulcers. The profile adjusters will modify the profile of mask according to facial geometry of patient so gap between skin and mask can be sealed while providing ventilation.

Figure 7 shows a flow diagram for setting up of the interface device on a user’s face according to the present invention. The ergonomically designed mask of the interface device is mounted on the face of the patient covering his/her nose and mouth. The strap comprises strips having fasteners. The strips are closed and the strap or the belt is tightened. The tightening of the belt is comparatively less so as to keep the mask in position. The mask is then adjusted on the face of the user using at least four profile adjusters on the mask. It is to be understood that the number of adjusters as mentioned can vary and should not be considered as any limitation to the present invention. Such adjusters can be some kind of mechanism which will push particular section of liner to make profile curve more emphasized if needed. The adjustment of the mask is done according to the facial geometry of the person. Once the mask is mounted on the face of the person, the ventilation process commences using the BiPAP device.

In the herein disclosed device, the liners or the cushions can inflate and deflate in cycle. This feature is not existent in the prior art solutions. All the existing masks have fixed profile which is not suitable for every facial geometry. The liners or cushions advantageously inflate when higher air pressure will supply to patient and the mask of the interface device will be tight to prevent leakages. The same liner or cushion will deflate and mask of the interface device will be loose to reduce pressure on skin under lower air pressure to reduce chances of pressure ulcer development or face injury.

Therefore, in the herein disclosed device, the higher air pressure for ventilation is advantageously utilized to inflate the liners i.e. to tighten the mask of the interface device. However, the inflation and deflation can also be done separately by different system of pump and actuator according to another embodiment of the invention. That way, inflation and deflation will not be dependent on ventilation pressure and the ratio of inflation and deflation can be set according to requirement which is specific to the user. The liners disclosed in the device are having modifiable liner profile. Therefore, the mask of the interface device is advantageously compatible with different facial geometries. One size of mask will be good enough for majority of face sizes also. Inflation during air supply will also provide tactile feedback to patient and hence the synchronization will be improved. These all features will help to improve overall efficacy of NIV system.

Figures 8A-8D illustrate different 3-Dimensional views of an interface device for non-invasive ventilation to people having different facial geometries, in accordance to the embodiments as already illustrated in Figures 2B-2E.

In an embodiment, a non-invasive ventilation, NIV system for patients, comprises an interface device adapted to fit human faces having different facial geometries as described herein.

In an embodiment, a non-invasive ventilation, NIV method for patients, is performed by a system comprising an interface device adapted to fit human faces having different facial geometries.

Some of the noteworthy features of the present invention are mentioned below:

• The existing interfaces do not change its profile and applies constant pressure on skin, as opposed to which in the present invention, the tightening of mask is only required while supplying higher air pressure for inhalation.

• The tightening of the mask is with no compromise on the comfort of the user. • The device will tighten and loosen the mask in cycles which will reduce average pressure on skin and it will be tighten under higher air pressure so leakages will also be reduced.

• The masks known in the art have 3 sizes but the device disclosed herein can be used on majority of face sizes and facial profiles.

• With the device of the present invention the overall synchronization of the device is improved and so is the overall efficacy of NIV system.

In the following are enlisted the reference numerals and corresponding features used in Figures 2B-2E:

I. Silicon cushion 2. Intermediate attachment

3. Inflatable air bladder inlet 4. Interface shell 5. Interface elbow 6. Exhalation port 7. Bottom strap mount 8. Inflatable bladder

9. Flexible joint 10. Forehead support

II. Top strap mount 12. Forehead cushion 13. Top strap 14. Bottom strap

In the following are enlisted the reference numerals and corresponding features used in Figure 3:

31: silicon hollow liner 32: transparent casing 33: 02 supply 34: nebulization port

35: rubber straps 36: chin section

37: sticky patch 38: casing line

In the following are enlisted the reference numerals and corresponding features used in Figure 6: 61: Silicon liner / cushion 62: Transparent casing 63: Air supply port to patient 64: Profile adjuster 65: Nasal part of the liner

66: Silicon tube to supply air from liner to patient 67: Strips

68: Chin section slot to fit liner if smaller mask size of the interface device is required. It is to be appreciated that such design of the slot and the mechanism involved may vary within the spirit of the present invention to fit different ergonomics of different faces a: Casing front b: Casing back c: Silicon liner x: Flat liner profile y: Adjusted liner profile according to facial geometry

Claims

Claims:

1. An interface device for non-invasive ventilation, NIV, to a patient, and adapted to fit human faces having different facial geometries, characterized in that, the interface device comprises: a mask comprising: a casing adapted to form an enclosure around oral and nasal cavities of a patient; a silicon liner or cushion adapted to fit the casing of the mask, said liner or cushion being adapted to comfortably fit facial skin of a patient, and reduce leakage of breathing gas, using Bilevel Positive Airway Pressure, BiPAP mechanism, wherein under higher positive air pressure, the liner is adapted to inflate and under lower positive air pressure, the liner is adapted to deflate.

2. The interface device as claimed in claim 1, wherein the device comprises: a plurality of bottom straps fixed to a bottom strap mount located at the bottom portion of the casing and a plurality of top straps fixed to a top strap mount located atop the casing.

3. The interface device as claimed in claim 1, wherein the device comprises: an intermediate attachment adapted to fit the silicon liner or cushion on one side and coupled to an interface shell on the other side, wherein the interface shell comprises: an inflatable air bladder within the interface shell, wherein cyclic inflation and deflation of air bladder increases and decreases interface pressure on the patient’s face; an interface elbow adapted to attach a NIV pipe for ventilation, wherein the interface elbow can be moved in any direction; and an exhalation port.

4. The interface device as claimed in claim 3, wherein the device comprises: a forehead support fixed to the interface shell via a flexible joint, facilitating in distributing pressure to the forehead from nasal bridge and adapted to couple the plurality of top straps fixed to a top strap mount located on it; and a forehead cushion at the end of the forehead support for proper support and comfort on the face of the patient.

5. The interface device as claimed in claim 4, wherein the forehead cushion is of silicon or similar biocompatible material.

6. The interface device as claimed in claim 3, wherein external air supply from a NIV/extemal device inflates and deflates the air bladder by filling air in and out through an inflatable air bladder inlet.

7. The interface device as claimed in claim 3, wherein the exhalation port is a simple silicon flap or a specially designed hepa filter can be fixed on it.

8. The interface device as claimed in claim 3, wherein silicon liners or cushions of different sizes can be attached to an intermediate attachment.

9. The interface device as claimed in claim 1, wherein the silicon liner or cushion is a hollow, inflatable liner or cushion.

10. The interface device as claimed in claim 9, wherein the device comprises a nebulization port for administration of medications while breathing.

11. The interface device as claimed in claim 9, wherein the silicon liner or cushion comprises a sticky patch and a casing line to adjust the sealing surface according to facial profile by stretching the cross section of liner at a particular location.

12. The interface device as claimed in claim 9, wherein the device comprises: a plurality of profile adjusters on the casing of the mask; and at least two holes in the casing of the mask for inhale of oxygen and exhale of the air containing carbon dioxide; wherein the plurality of profile adjusters is adapted to change the profile of the silicon liner or cushion, at determined sections, according to facial geometry of the patient.

13. The interface device as claimed in claim 9, wherein high-pressure air builds up in the mask consequent to inhalation of air and the mask becomes tighter facilitating low leakage as the silicon liner inflates, and during exhalation, the pressure of air in the mask is low facilitating loosening of the mask as the silicon liner deflates.

14. The interface device as claimed in claim 9, wherein the inflation and deflation of the silicon liner or cushion is done separately by a pump and an actuator, wherein the ratio of inflation and deflation can be set according to requirement which is specific to the user.

15. The interface device as claimed in claim 1, wherein the silicon liner or cushion is replaceable.

16. A non-invasive ventilation, NIV system for patients, comprises an interface device adapted to fit human faces having different facial geometries as claimed in any one of claims 1-15.

17. A non-invasive ventilation, NIV method for patients, by an interface device adapted to fit human faces having different facial geometries as claimed in any one of claims 1-15.