AU2017216252A1

AU2017216252A1 - Sleepystrip disposable breathing apparatus

Info

Publication number: AU2017216252A1
Application number: AU2017216252A
Authority: AU
Inventors: Daniel Hanson; Daniel Willis; Karen WILLIS
Original assignee: Sleepystrip Pty Ltd
Current assignee: Sleepystrip Pty Ltd
Priority date: 2016-02-01
Filing date: 2017-01-24
Publication date: 2018-09-13
Also published as: CA3051446A1; WO2017132723A1

Abstract

The invention relates to an article and a method of nasal breathing with a device to relieve a common condition generally known medically as Sleep Disordered Breathing (SDB).

Description

TITLE

Sleepystrip Disposable Breathing Apparatus FIELD OF THE INVENTION

BACKGROUND OF THE INVENTION

The Respiratory Tract is the part of the anatomy involved with the process of respiration. The Respiratory Tract is divided into the Upper Airways and Lower Airways. The Upper Airways or Upper Respiratory Tract includes the nose and nasal passages, paranasal sinuses, the pharynx, and the portion of the larynx above the vocal cords.

The Lower Airways or Lower Respiratory Tract includes the portion of the larynx below the vocal cords, trachea, bronchi and bronchioles. The lungs can be included in the Lower Respiratory Tract or as separate entity and include the respiratory bronchioles, alveolar ducts, alveolar sacs and alveoli. Most of the Respiratory Tract exists merely as a piping system for air to travel in the lungs, and alveoli are the only part of the lung that exchanges oxygen and carbon dioxide with the blood. When inhaling the air travels down the trachea through the bronchial tubes and into the lungs. The entire tract is protected by the rib cage spinal cord and sternum bone. In the lungs oxygen from the inhaled air is transferred into the blood and circulated throughout the body. Carbon dioxide (CO2) is transferred from returning blood back into gaseous form in the lungs and exhaled through the lower respiratory tract and then the upper, to complete the process of breathing.

Nasal Breathing is breathing through the nose. The importance of breathing through the nose rather than the mouth was recognized in the 19th century. Hendrik Zwaardemaker (1857 - 1930), a Dutch Scientist, studied nose breathing and invented a device to measure the amount of airflow through each nostril called a Rhinomanometer. The Rhinomanometer is a standard diagnostic tool aiming to objectively evaluate the respiratory function of the nose. It measures pressure and flow during normal inspiration and expiration through the nose. Increased pressure during respiration is a result of increased resistance to airflow through nasal passages a condition known as nasal blockage while increased flow, which means the speed of airstream, is related to better patency. Nasal obstruction leads to increased values of nasal resistance.

Research has proved that Nasal Breathing is considered superior to Mouth Breathing for several reasons. Air travels to and from the external environment and the lungs through the nasal passages as opposed to the mouth. The nasal passages do a better job of filtering the air as it enters the lungs. In addition, the smaller diameter of the nasal passages creates pressure in the lungs during exhalation, allowing the lungs to have more time to extract oxygen from them. When there is proper oxygen-carbon dioxide exchange, the blood will maintain a balanced pH. If carbon is lost too quickly as in mouth breathing, oxygen absorption decreases. This is known medically as The Bohr Effect.

Nasal breathing is especially important in certain situations such as dehydration, cold weather, and when the throat is sore or dry because it does not dry the throat as much. Nose breathing warms and humidifies the inhaled air. Nasal breathing increases circulation, cellular oxygen and blood carbon dioxide levels. It can also slow the breathing rate and improve overall lung volumes (Swift, Campbell, McKown 1988 Oronasal obstruction, lung volumes, and arterial oxygenation. Lancet 1, 73-75).

In their study "An assessment of nasal functions in control of breathing" (Tanaka et al, 1988), Japanese researchers discovered that end-tidal-CC>2 concentrations were higher and more ideal during nose breathing than during oral breathing. This research study revealed that a group of healthy volunteers had an average CO2 of about 43.7 mm Hg for nose breathing and only around 40.6 mm Hg for oral or mouth breathing. CO2 is not a toxic waste gas. Research articles on respiration often mention dead space, a physiological parameter, which is about 150-200 ml in an average adult person. Dead space is inside the nose, throat, and bronchi. This space helps to preserve additional CO2 for the human body to invest elsewhere. During inhalations we take CO2 enriched air from our dead space back into the alveoli of the lungs. When the mouth is used for respiration, the dead space volume decreases, since nasal passages are no longer a part of the breathing route. This has the negative effect of reducing alveolar CO2 and reducing arterial blood CO2 concentrations. Thus, resulting is a less efficient cellular oxygenation per Bohr Effect. Such a negative effect does not take place with nose breathing. Furthermore, the nasal-breathing route provides more resistance for respiratory muscles as compared to oral breathing as the route for mouth breathing is shorter and it has a greater cross sectional area. This stimulates diaphragmatic breathing with potential positive consequences to the autonomic nervous system resulting in relaxation.

Normal nose breathing helps us to use our own Nitric Oxide (NO), which is generated, in the sinuses. There have been over 60,000 studies completed on nitric oxide and in 1998 the Nobel Prize for Medicine was given to three scientists that discovered the signaling role of nitric oxide. Nitric Oxide (NO) dilates blood vessels of heart patients, reducing their blood pressure and heart rate. Hence, they can survive a heart attack.

This gas is produced in various body tissues, including nasal passages. It is routinely measured in exhaled air coming from nasal passages. Therefore, it cannot be so easily utilized when mouth breathing.

The confirmed functions of nitric oxide are: • Destruction of viruses, parasitic organisms, and malignant cells in the airways and lungs by inactivating their respiratory chain enzymes. • Regulation of binding - release of O2 to hemoglobin. This effect is similar to the CO2 function (the Bohr effect). • Vasodilation of arteries and arterioles (regulation of blood flow or perfusion of tissues). • Inhibitory effects of inflammation in blood vessels. • Hormonal effects. Nitric Oxide (NO) influences secretion of hormones from several glands (adrenaline, pancreatic enzymes, and gonadotropin-releasing hormone) • Neurotransmission. Memory, sleeping, learning, feeling pain, and many other processes are possible only with (Nitric Oxide) NO present (for transmission of neuronal signals).

Continuous Positive Airway Pressure (CPAP) is primarily the most common ameliorative treatment of Sleep Disordered Breathing (SDB). CPA treatment, as described in US Patent No. 4,944,310, provides pressurized air or other breathable gas to the entrance of a person’s airways at a pressure elevated above atmospheric pressure, typically in the range 4-20cm H2O. It is also known for the level of treatment pressure to vary from breath to breath in accordance with the person’s need, that form of CPAP being known as automatically adjusting nasal CPAP treatment, as described in US Patent No. 5,245,995. Another form of treatment for SDB is Non Invasive Positive Pressure Ventilation (NIPPV). NIPPV can involve a relatively higher pressure of gas being provided in the person’s mask during the inspiratory phase of respiration and a relatively lower pressure or atmospheric pressure being provided in the person’s mask during the expiratory phase of respiration. In other NIPPV modes the pressure can be made to vary in a complex manner throughout the respiratory cycle. For example, the pressure at the mask during inspiration or expiration can be varied through the period of treatment. Typically, the ventilator assistance for CPAP or NIPPV treatment is delivered to the person by way of a nasal mask. Alternatively, a mouth mask or full-face mask or nasal prongs can be used. In this specification any reference to a mask is to be understood as incorporating a reference to a nasal mask, mouth mask, full-face mask or nasal prongs. In this specification any reference to CPAP treatment is to be understood as embracing all, or some of the above described forms of ventilator treatment or assistance. A CPAP apparatus broadly comprises a flow generator constituted by a continuous source of air or other breathable gas generally in the form of a blower or turbine driven by an electric motor. A hospital piped supply can also be used. The gas supply is connected to a person’s mask, which incorporates, or has in close proximity, an exhaust to atmosphere for venting exhaled gases. The electric motor driving the blower is typically controlled by a servo-controller under the control of a micro controller unit. A problem experienced by people undergoing nasal CPAP treatment or NIPPV is that of air escaping (leaking) via the mouth. This leads to drying and dehydration of the nasal passages, reduction in the pressure of the treatment gas being delivered to the lungs, reduction in the amount of ventilatory assistance and, where applicable, incorrect triggering or cycling of ventilator assistance devices.

These and other problems are discussed in the article “Air Leaking Through the Mouth during Nocturnal Nasal Ventilation: Effect on Sleep Quality” by Meya, Thomas J. etal, published in Sleep, Vol. 20, No. 7, 1997 (561-569). Hitherto, there have been several attempts to solve this problem. One approach uses a chinstrap to pull the lower jaw of the patient upwardly against the upper jaw to close the mouth. However, air is still able to leak through the lips and extreme cases the air cause the lips to flap in a “raspberry” fashion.

Japanese Patent Application No. 9-183809 discloses a U-shaped piece of rigid tape that is adhered to the upper and lower jaws but not the upper and lower lips that appears to function in a similar manner to the chinstrap described above. A variation of this approach involves adding a layer of cloth over the lips of the person. Any air passing through the person’s lips must be force through the cloth thereby reducing leakage. The device can be uncomfortable and still allows air to leak through the person’s mouth. A similar approach is disclosed in United States Patent No's. 5640974 and 5690121 both in the name of Miller. These patents disclose a chin support device in the form of a U or V-shaped piece of adhesive material having a base adhered to the person's chin below the bottom lip and two arms which extend up the face towards the cheeks to support the user's lower lip upwardly against the user's upper lip. However, as the lips themselves are not pressed against one another air is still able to leak through the lips as described above. A further variation is disclosed in US Patent No. 4817636 in the name of Woods. This patent discloses an anti snoring device in the form of a sheet of material having a peripheral adhesive edge for adhering the material over the user's mouth. However, this device also does not press the lips together and allows air to leak in the manner described above. Further, the device does not allow mouth breathing, coughing or speaking if the wearer's nose becomes clogged or other emergency situations arise.

It is an object of the present invention to substantially overcome or at least ameliorate one or more of the prior art deficiencies.

Summary of Invention

The present invention provides a disposable apparatus for preventing or reducing the passage of air through a person’s mouth to encourage better nasal breathing including: an individual portion and a single component which acts as a patch with the outer side smooth, is non-adhesive and the inner side is coated with an adhesive to allow adhesion to a person’s face above the person’s top lip and located either side of the nose and covering the person’s mouth and adhered to the person’s face under the person’s bottom lip located on and under the person’s chin.

Preferably, the apparatus is a single component.

Preferably, the apparatus is a non-woven, porous, breathe free medical pressure-sensitive adhesive that is hypoallergenic and latex free to improve skin comfort and having one side coated with a medical grade adhesive.

Preferably, the apparatus has a smooth outer surface.

Preferably, the apparatus is equipped with a non-adhesive area on the bottom of the apparatus, located on and under the person’s chin, to assist with adjustment and easy removal of the apparatus after use and allow for easy adjustment or removal should the person need to cough or speak.

Preferably, the apparatus improves End Tidal Carbon Dioxide levels. Preferably, the apparatus improves breathing patterns of a person. Preferably, the apparatus improves Cellular Oxygenation of a person. Preferably, the apparatus improves and assists with filtering the air inhaled by a person.

Preferably, the apparatus improves and assists with humidifying the air inhaled by a person.

Preferably, the apparatus improves and assists a person with sleep. Preferably, the apparatus will reduce snoring.

Preferably, the apparatus will reduce the noise a person makes while snoring.

Preferably, the apparatus will hold a person’s Mandible forward during sleep.

Preferably, the apparatus will assist a person with tongue posture during sleep.

Preferably, the apparatus will assist and improve concentration of a person using the apparatus.

Preferably, the apparatus will assist and improve a person’s performance during sport or any other physical activity.

Preferably, the apparatus will keep a person’s mouth closed during sleep or any other occasion the apparatus is worn by a person in all other circumstances.

Preferably, the apparatus will assist with keeping a person’s nose unblocked.

Preferably, the apparatus will assist in the reduction of congestion in a person.

Preferably, the apparatus will increase a person’s energy levels by assisting a person to correctly breathe through the nose while sleeping and in all other activities.

Preferably, the apparatus will assist with Oral Myology.

Preferably, the apparatus allows a person to keep their mouth closed with ease and comfort.

Preferably, the apparatus to allow and encourage a person to breath efficiently and effectively via the nasal cavity.

Preferably, the apparatus will assist a person, when resting or sleeping on their side, will not obstruct or interfere with the side of the person’s face.

Preferably, the apparatus will ensure a person’s facial skin is not crumpled, stretched or pulled whilst a person is wearing the apparatus.

Preferably, the apparatus includes holes cut out of the apparatus, either in a round, oval or square shape, to reduce the psychological stress, or fear a person may experience with wearing the apparatus over their mouth.

Preferably, the apparatus has a unique design that is disposable after a single use.

Preferably, the apparatus has a unique design of disposability that improves hygiene for a person.

Preferably, the apparatus is non-invasive to a person using the apparatus.

Preferably, the apparatus can be customized and modified by a person to fit a person’s needs.

Preferably, the apparatus allows the jaw of a person to be aligned in the correct position to allow proper nasal breathing whilst asleep or doing any other activity.

Preferably, the apparatus allows the person’s airways to be opened for proper breathing whilst asleep or doing any other activity.

Preferably, the apparatus allows the person to apply the apparatus. Preferably, the apparatus allows the person to remove the apparatus for any reason with ease.

Preferably, the apparatus allows portability for travel and storage purposes.

Preferably, the apparatus requires no battery or electricity for use. Preferably, the apparatus allows another person to apply the apparatus to another person.

Preferably, the apparatus includes a non-stick tab at the bottom of the apparatus to allow a person to remove and replace the apparatus as required.

Preferably, the apparatus allows the apparatus to be used by any person as a demonstration and teaching apparatus.

Preferably, the apparatus creates an external environment for people to breathe in an optimal way by closing the person’s mouth to allow optimal breathing through the nose.

Preferably, the apparatus covers the mouth has two vertical or horizontal holes (shapes of the holes can include round, oval, oblong or square or any other shape) acting as openings located over the centre of the mouth to assist with correct positioning over the mouth, and reassure the person that they will not be at risk of suffocation. Preferably, the apparatus can be scaled in size to meet requirements of adults or children.

Preferably, the apparatus can be used in conjunction with any other device or apparatus used inside a person’s mouth for the purpose of facial development.

Preferably, the apparatus can be used in conjunction with any other device or apparatus used inside a person’s mouth for the purpose of the prevention of snoring and other breathing difficulties and other sleep related disorders.

Preferably, shape of the apparatus is configured to represent substantially any one of letters Μ, Y or S or a combination thereof.

In another aspect, the present invention provides a method for preventing or reducing the passage of air through a person’s mouth to encourage better nasal breathing comprising attaching the apparatus according to the present invention to a person’s nose and mouth region.

BRIEF DESCRIPTION OF DRAWINGS

Fig. 1 is a front view of the apparatus with all measurements

Fig. 2 is a front view of the unadjusted apparatus attached to a person’s face

Fig. 3 is a front view of the apparatus showing the adjustment lines on the apparatus

Fig. 4 is a front view of the apparatus attached to a person’s face showing the adjustment at the bottom portion of the apparatus that attaches under the person’s chin

Fig. 5 is a front view of the apparatus attached to a person’s face showing the adjustment of the apparatus on the two sides of the apparatus that attaches to the person’s face beside the nose

Fig. 6 is a front view of the apparatus attached a person’s face showing the adjustment of the apparatus on the two sides of the apparatus that attaches to the person’s face beside the nose and the adjustment of the apparatus at the bottom portion of the apparatus that attaches under the person’s chin Fig. 7 is a front view of the apparatus showing the position of the two vertical holes (shapes of the holes can include round, oval, oblong or square or any other shape) acting as openings located over the centre of the mouth to assist with correct positioning over the mouth, and reassure the person that they will not be at risk of suffocation.

DETAILED DESCRIPTION OF THE INVENTION

The invention relates to a method of nasal breathing with a device to relieve a common condition generally known medically as Sleep Disordered Breathing (SDB). The condition is caused by mouth inhalation of air when asleep and the innovation is designed to prevent or reducing the passage of air through a person’s mouth, thus enabling nose breathing to become the dominant route of inhalation and exhalation.

The invention has been developed primarily for use as a non-invasive mouth seal and acts as an alternative way to improve breathing through the nasal cavity.

The invention also has a secondary use that can act as a non-invasive natural non mechanical alternative to assist in the maintenance of good health of the upper and lower respiratory tract and assist in the management of exacerbated Sleep Disordered Breathing (SDB) difficulties occurring during sleep. SDB can range from frequent loud snoring to Obstructive or Central Sleep Apnea (OSA / CSA) which is a condition involving repeated episodes of partial or complete cessation of airflow during sleep.

Particularly, the present invention provides a disposable apparatus for preventing or reducing the passage of air through a person’s mouth to encourage better nasal breathing. The disposable apparatus also will assist with a Close Mouth Posture by bringing the lips together while a person sleeps or any other activity at any other time. The disposable apparatus, while bringing the lips together, will specifically disable the lips from coming apart or opening during sleep or any other activity. The disposable apparatus will promote and assist with normal functional nasal breathing.

In one embodiment, the disposable apparatus is an individual portion and a single component and acts as a patch with the outer side smooth and nonadhesive and the inner side that is coated with an adhesive and the adhesive used is medical pressure sensitive adhesive that is safe and hypoallergenic and the medical pressure sensitive adhesive described is not limited to any other superior or similar adhesive to allow adhesion to a person’s face above the person’s top lip and located either side of the nose and covering the person’s mouth and adhered to the person’s face under the person’s bottom lip located on and under the person’s chin. The disposable apparatus is shaped in a Ύ” form from the front view. The surface of the disposable apparatus that covers the mouth has two vertical holes (shaped include round, oval, oblong or square) acting as openings located over the centre of the mouth to assist with correct positioning over the mouth, and reassure the person that they will not be at risk of suffocation. The surface area of the disposable apparatus that seals onto the person’s face and over the person’s mouth are covered with appropriate medical grade self adhesive, which prevents the apparatus from slipping due to movement. The disposable apparatus fabric is a non-woven, porous, breathe free medical pressure-sensitive adhesive that is hypoallergenic and latex free however the fabric described is not limited to any other superior or similar fabrics. The disposable apparatus can be modified and adjusted, by the person, for user comfort, by cutting the disposable apparatus at the top and bottom parts of the apparatus. The disposable apparatus is equipped with a non-adhesive area on the bottom of the apparatus, located on and under the person’s chin, to assist with adjustment and easy removal of the disposable apparatus after use and allow for easy adjustment or removal and re-application should the person need to cough or speak. The apparatus is in disposable form and is disposed of after each one use.

The applicant’s innovation takes into account previous attempts to address issues disclosed and confronted previously by others but with limited success. This invention discloses a markedly different design, being a Ύ” shape, and located at the bottom of the apparatus in the area under or on the person’s chin, is a non-adhesive area that acts as a “tab” to assist with adjustment and easy removal of the apparatus after use and allow for easy adjustment or removal and re-application should the person need to cough or speak. Preferably the apparatus is in a disposable form and is disposed of after a single use. This provides a unique and novel approach to the commercial viability of the apparatus.

The design recognizes the variability in human airway anatomy, and even further variation in the pathological changes contributing to Sleep Disordered Breathing (SDB) and related disorders. Moreover, the pathological anatomy changes over time in each person as his or her condition improves or deteriorates. It is agreed that no single method, device or apparatus is able to treat all contingencies. This application recognizes a critical need for methods, devices and apparatus that are optimized for different sites in the human airway.

Preferably the present invention provides an apparatus for preventing or reducing the passage of air through a person’s mouth, the apparatus and the embodiments of the invention have other advantages over the prior art than those previously mentioned, including: • Being an individual portion and a single component; • Acting as a patch; • The outer side being smooth and non-adhesive; • The inner side is coated with an adhesive to allow adhesion to a person’s face above the person’s top lip and located either side of the nose and covering the person’s mouth and adhered to the person’s face under the person’s bottom lip located on and under the person’s chin; • Being an Ύ” shaped apparatus from the front view • The surface of the disposable apparatus that covers the mouth has two vertical holes (shapes of the holes can include round, oval, oblong or square or any other shape) acting as openings located over the centre of the mouth to assist with correct positioning over the mouth, and reassure the person that they will not be at risk of suffocation. • The surface area of the apparatus that seals onto a person’s face and over the person’s mouth is covered with appropriate medical grade self adhesive, which prevents the apparatus from slipping due to movement; • The disposable apparatus fabric is a non-woven, porous, breathe free medical pressure-sensitive adhesive that is hypoallergenic and latex free to improve skin comfort; • The ability to be modified and adjusted, by the person, for user comfort, by cutting the apparatus at the top and bottom parts of the apparatus; • Being equipped with a non-adhesive area on the bottom of the apparatus, located on and under the person’s chin, to assist with adjustment and easy removal of the apparatus after use and allow for easy adjustment or removal and reapplication should the person need to cough or speak; • Being simple to fit to a person’s face; • Not requiring chin restraints, neck straps or multiple portions; • Being inexpensive to manufacture and sell; • Having a low profile making the apparatus less cumbersome to wear and less prone to dislodgment during movements in sleep; • The ability to be used with nasal or full-face masks; and • Being produced as a disposable item for disposal after each use. • Due to the shape and design of the apparatus it can be scaled in size to fit any person, for example adults and children.

Further, the apparatus according to the present invention - includes any shape holes in the design - can be designed with or without holes - can be manufactured in any shape ie. manufactured in the shape of an “Μ”, “Y”, or and “S” for instance. Shapes of the holes can include round, oval, oblong or square or any other shape, for example. - can be made from any suitable material including adhesive material, for example, a non-woven, porous, breathe free medical pressure-sensitive adhesive that is hypoallergenic and latex free to improve skin comfort and having one side coated with a medical grade adhesive.

The invention has been described with reference to specific examples but may well extend to other respiratory illnesses and conditions not yet identified.

While considerable emphasis has been placed herein on the specific features of the preferred embodiment, it will be appreciated that many additional features can be added and that many changes can be made in the preferred embodiment without departing from the principles of the disclosure. These and other changes in the preferred embodiment of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

Claims

CLAIMS The Claims defining the invention are as follows:

1. A disposable apparatus for preventing or reducing the passage of air through a person’s mouth to encourage better nasal breathing including: an individual portion and a single component which acts as a patch with the outer side smooth, is non-adhesive and the inner side is coated with an adhesive to allow adhesion to a person’s face above the person’s top lip and located either side of the nose and covering the person’s mouth and adhered to the person’s face under the person’s bottom lip located on and under the person’s chin.
2. The apparatus as claimed in claim 1, wherein the apparatus is a single component.
3. The apparatus as claimed in any one of claims 1 to 2, wherein the apparatus is a non-woven, porous, breathe free medical pressure-sensitive adhesive that is hypoallergenic and latex free to improve skin comfort and having one side coated with a medical grade adhesive.
4. The apparatus as claimed in any one of claims 1 to 3, wherein the apparatus has a smooth outer surface.
5. The apparatus as claimed in any one of claims 1 to 4, wherein the apparatus is equipped with a non-adhesive area on the bottom of the apparatus, located on and under the person’s chin, to assist with adjustment and easy removal of the apparatus after use and allow for easy adjustment or removal should the person need to cough or speak.
6. The apparatus as claimed in any one of claims 1 to 5, wherein the apparatus improves End Tidal Carbon Dioxide levels.
7. The apparatus as claimed in any one of claims 1 to 6, wherein the apparatus improves breathing patterns of a person.
8. The apparatus as claimed in any one of claims 1 to 7, wherein the apparatus improves Cellular Oxygenation of a person.
9. The apparatus as claimed in any one of claims 1 to 8, wherein the apparatus improves and assists with filtering the air inhaled by a person.
10. The apparatus as claimed in any one of claims 1 to 9, wherein the apparatus improves and assists with humidifying the air inhaled by a person.
11. The apparatus as claimed in any one of claims 1 to 10, wherein the apparatus improves and assists a person with sleep.
12. The apparatus as claimed in any one of claims 1 to 11, wherein the apparatus will reduce snoring.
13. The apparatus as claimed in any one of claims 1 to 12, wherein the apparatus will reduce the noise a person makes while snoring.
14. The apparatus as claimed in any one of claims 1 to 13, wherein the apparatus will hold a person’s Mandible forward during sleep.
15. The apparatus as claimed in any one of claims 1 to 14, wherein the apparatus will assist a person with tongue posture during sleep.
16. The apparatus as claimed in any one of claims 1 to 15, wherein the apparatus will assist and improve concentration of a person using the apparatus.
17. The apparatus as claimed in any one of claims 1 to 16, wherein the apparatus will assist and improve a person’s performance during sport or any other physical activity.
18. The apparatus as claimed in any one of claims 1 to 17, wherein the apparatus will keep a person’s mouth closed during sleep or any other occasion the apparatus is worn by a person in all other circumstances.
19. The apparatus as claimed in any one of claims 1 to 18, wherein the apparatus will assist with keeping a person’s nose unblocked.
20. The apparatus as claimed in any one of claims 1 to 19, wherein the apparatus will assist in the reduction of congestion in a person.
21. The apparatus as claimed in any one of claims 1 to 20, wherein the apparatus will increase a person’s energy levels by assisting a person to correctly breathe through the nose while sleeping and in all other activities.
22. The apparatus as claimed in any one of claims 1 to 21, wherein the apparatus will assist with Oral Myology.
23. The apparatus as claimed in any one of claims 1 to 22, wherein the apparatus allows a person to keep their mouth closed with ease and comfort.
24. The apparatus as claimed in any one of claims 1 to 23, wherein the apparatus to allow and encourage a person to breath efficiently and effectively via the nasal cavity.
25. The apparatus as claimed in any one of claims 1 to 24, wherein the apparatus will assist a person, when resting or sleeping on their side, will not obstruct or interfere with the side of the person’s face.
26. The apparatus as claimed in any one of claims 1 to 25, wherein the apparatus will ensure a person’s facial skin is not crumpled, stretched or pulled whilst a person is wearing the apparatus.
27. The apparatus as claimed in any one of claims 1 to 26, wherein the apparatus includes holes cut out of the apparatus, either in a round, oval or square shape, to reduce the psychological stress, or fear a person may experience with wearing the apparatus over their mouth.
28. The apparatus as claimed in any one of claims 1 to 27, wherein the apparatus has a unique design that is disposable after a single use.
29. The apparatus as claimed in any one of claims 1 to 28, wherein the apparatus has a unique design of disposability that improves hygiene for a person.
30. The apparatus as claimed in any one of claims 1 to 29, wherein the apparatus is non-invasive to a person using the apparatus.
31. The apparatus as claimed in any one of claims 1 to 30, wherein the apparatus can be customized and modified by a person to fit a person’s needs.
32. The apparatus as claimed in any one of claims 1 to 31, wherein the apparatus allows the jaw of a person to be aligned in the correct position to allow proper nasal breathing whilst asleep or doing any other activity.
33. The apparatus as claimed in any one of claims 1 to 32, wherein the apparatus allows the person’s airways to be opened for proper breathing whilst asleep or doing any other activity.
34. The apparatus as claimed in any one of claims 1 to 33, wherein the apparatus allows the person to apply the apparatus.
35. The apparatus as claimed in any one of claims 1 to 34, wherein the apparatus allows the person to remove the apparatus for any reason with ease.
36. The apparatus as claimed in any one of claims 1 to 35, wherein the apparatus allows portability for travel and storage purposes.
37. The apparatus as claimed in any one of claims 1 to 36, wherein the apparatus requires no battery or electricity for use.
38. The apparatus as claimed in any one of claims 1 to 37, wherein the apparatus allows another person to apply the apparatus to another person.
39. The apparatus as claimed in any one of claims 1 to 38, wherein the apparatus includes a non-stick tab at the bottom of the apparatus to allow a person to remove and replace the apparatus as required.
40. The apparatus as claimed in any one of claims 1 to 39, wherein the apparatus allows the apparatus to be used by any person as a demonstration and teaching apparatus.
41. The apparatus as claimed in any one of claims 1 to 40, wherein the apparatus creates an external environment for people to breathe in an optimal way by closing the person’s mouth to allow optimal breathing through the nose.
42. The apparatus as claimed in any one of claims 1 to 41, wherein the apparatus covers the mouth has optionally no holes, or vertical or horizontal holes, or preferably at least one or two holes, shapes of the holes can include round, oval, oblong or square or any other shape, holes acting as openings located over the centre of the mouth to assist with correct positioning over the mouth, and reassure the person that they will not be at risk of suffocation.
43. The apparatus as claimed in any one of claims 1 to 42, wherein the apparatus can be scaled in size to meet requirements of adults or children.
44. The apparatus as claimed in any one of claims 1 to 43, wherein the apparatus is used in conjunction with any other device or apparatus used inside a person’s mouth for the purpose of facial development.
45. The apparatus as claimed in any one of claims 1 to 44, wherein the apparatus is used in conjunction with any other device or apparatus used inside a person’s mouth for the purpose of the prevention of snoring and other breathing difficulties and other sleep related disorders.
46. The apparatus as claimed in any one of claims 1 to 45 wherein shape of the apparatus is configured to represent substantially any one of letters Μ, Y or S or a combination thereof.
47. The apparatus as claimed in any one of claims 1 to 46 wherein any adhesive used in the manufacture of the apparatus is non-chemical or chemical free.
48. The apparatus as claimed in any one of claims 1 to 47 wherein material for the apparatus is manufactured in a selection of colours.
49. The apparatus according to claim 46 wherein the apparatus is disposable and shaped in a Ύ” form from the front view, the surface of the disposable apparatus that covers the mouth has two vertical holes acting as openings located over the centre of the mouth to assist with correct positioning over the mouth, and to reassure the person that they will not be at risk of suffocation.
50. A method for preventing or reducing the passage of air through a person’s mouth to encourage better nasal breathing comprising attaching the apparatus according to claim 1 to a person’s nose and mouth region.
51. A method for preventing or reducing the passage of air through a person’s mouth to encourage better nasal breathing comprising attaching the apparatus according to any one of claims 1 to 49 to a person’s nose and mouth region.