GB2525640A

GB2525640A - Mono-block mandibular advancement mouthpiece

Info

Publication number: GB2525640A
Application number: GB1407644.2A
Authority: GB
Inventors: Paul R Swann; Michael D Williams
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-04-30
Filing date: 2014-04-30
Publication date: 2015-11-04
Also published as: GB201407644D0

Abstract

A mouth piece suitable for controlling sleep apnoea comprising a U-shaped mono block of rigid thermo-formable material 3 that has a large breathing hole 4 at its anterior point, and flanges extending along the inner and outer edges of the U-shaped block, which project from either side of the platform to define upper and lower U-shaped channels 1, 2 to receive the teeth of the upper and lower jaws respectively. The U-shaped channels 1, 2 are filled with a layer of soft thermo-formable polymer 5, and the mouth piece has a handle 7 to allow manipulation of the mouthpiece during a fitting process. Preferably the handle 7 is inserted into the large breathing space 4, and when the handle 7 is removed the tongue of the user may rest in the large breathing hole 4. To fit the mouth piece the device is heated to soften the soft thermo formable polymer layer 5, and the mouth piece via the handle 7 is inserted into a users mouth to allow the polymer layer 5 to be imprinted with the teeth of the user when their lower jaw is moved forward. Once the polymer layer 5 has cooled the mouth piece may be worn during sleep to control sleep apnoea. Preferably the heating and refitting to the mouthpiece can be repeated.

Description

FIELD OF THE INVENTION

This invention relates to a mouthpiece which controls mild to moderate sleep apnoea.

BACKGROUND OF THE INVENTION

Sleep apnoea is classified as sleep disorder which is characterised by pauses in breathing, infrequent or shallow breathing during the sleep. These breathing pauses can last between 10 to 20 seconds and can occur up to hundred times per night. The reason therefore is that soft tissues in mouth and throat become so relaxed and floppy during sleep that they collapse in the airway leading to narrowing or even completely blocking thereof.

Sleep apnoea is associated with daytime sleepiness and impaired alertness but also it can also lead to serious conditions such as hypertension and developing heart diseases such as heart attack or stroke.

Mild to moderate apnoea might be alleviated by life style changes such as weight loss, avoiding alcohol consumption and smoking, body position during sleep or use of CPAP (Continuous Positive Airways Pressure). CPAP involves use of special machine during sleep which prevents sleep apnoea by blowing air into a mask that covers nose and mouth which keeps the airways open.

Another method of managing sleep apnoea is use of mandibular advancement mouthpieces (MAD) which fit to upper and lower arch and position lower jaw forward. This holds the upper airway open and prevents the flabby tissues in the airway during sleep.

Mandibular advancement mouthpieces however might have side effect such as jaw joint damage and alteration of bite/mandibular extension, if they are not fitted correctly. Moreover, users complain of sore front lower teeth, teeth becoming loose, difficulty in retaining the right position, no room for the tongue and difficulty getting enough/correct advancement.

SUMMARY OF THE INVENTION

To overcome these problems the present invention proposes a mono-block mandibular mouthpiece to control mild to moderate sleep apnoea. The mouthpiece comprises mono-block form with large breathing hole at the anterior point lower and upper U-shaped channels that approximate dental arch and are adapted to fit lower and upper dentitions respectively, and a fitting handle to manipulate mouthpiece and help to achieve correct advancement of lower jaw during fitting process.

In embodiment of this invention the mono-block is made of rigid thermoplastic material preferably thermo-formable polymer to provide strength and maintain the airway open whilst supporting the jaw in a protrusive position whereas lower and upper U'shaped channels are lined with a layer of soft thermoplastic material preferably thermo-formable polymer enabling far superior rip and adaptation to the teeth during the fitting process. The two polymers work within the same mouthpiece to offer a better and more stable fit, eliminate tooth drifting a common issue with existing mouthpieces and provide a better customer/user experience of the invention.

Further embodiment of present invention also avoids expensive manufacture of customised mandibular advancement mouthpieces in dental laboratory as mouthpiece proposed by this invention can be easily fitted and customised by users by heating the mouthpiece till the soft thermoplastic material softens and inserting the mouthpiece into mouth whereas the lower and upper dentitions fit into the lower and the upper U-shaped channels. User bits into the layer of soft thermoplastic material which fills the lower and the upper U-shaped channels whilst moving the lower jaw forward and once convenient degree of advancement is achieved, the user removes the mouthpiece and allows it to cool to set the position of advancement. If some adjustment is required fitting process can be repeated number of times.

The invention will now be described solely by way of example and with reference to the accompanying drawings in which: Fig 1 shows top (left) and bottom (right) view of the mouthpiece and a handle for fitting thereof.

In figure 1, upper and lower U-shaped channels 1, 2 that approximate the dental arch and are adapted to fit with the upper and lower dentitions of an user. The upper and lower U-shaped channels 1, 2 are seamlessly joined by a mono-block form 3 with a large breathing space 4 at the anterior point. The mono-block is of rigid thermo-formable polymer compliant with FDA requirements for such mouthpieces.

The upper and lower U-shaped channels 1, 2 are lined with a soft thermo-formable polymer 5 covering the internal walls with varying thickness. Protruding nodes 6 from the side walls serve as reservoirs of low melting polymer, upon heating they become very fluid and biting into them causes the polymer to flow around the teeth and adapt thereto. The layer of the second thermo-formable polymer 5 has a lower vicat softening point compared to the supporting mono-block form 3.

The procedure for making the mouthpiece to fit properly in the user's mouth is described as follows: The mouthpiece is supplied with a fitting handle 7 inserted into the breathing hole 4 to preserve thereof and make the handling of the mouthpiece easier in hot water.

Water is boiled and poured into a suitable container and allowed to cool for 1 minute.

The mouthpiece is the immersed into the hot water for 2 minutes to soften the polymers. After 2 minutes it is removed and dunked into cold water for 1 second or less.

The mouthpiece is then placed in the mouth with the uppermost notch 6. The mouthpiece is then bitten into, whilst simultaneously moving the lower jaw forward by 2-3 mm, as a result of which the protruding fitting handle 7 rises due to drawbridge effect. The degree of lower forward movement is controlled by the user and is infinitely variable by repeating the above process.

Once a comfortable degree of forward advancement has been achieved the user should massage/rub his or her cheeks to help the layer of soft polymer 5 to adapt to the teeth. The soft polymer layer 5 and nodes 6 will be very fluid and adapt readily providing a snug retentive fit. The outer mono-block structure 3 will not conform so well but provides strength and stability to hold the lower jaw in the more advanced position.

After 2 minutes the polymers will have started to cool so the mouthpiece can be removed and placed in cold water for a further 2-3 minutes to fully cool and "set" in the position.

The mouthpiece should then be tried again to confirm if the fit and position is correct.

If some adjustment is required the above process can be repeated. Once the position is established and stable the fitting handle 7 can be removed and retained for possible future refitting of the mouthpiece.

The now exposed breathing space 4 allows for unrestricted airflow, the wide aperture allows air to flow slowly and avoids dry throat issues associated with smaller air channels and also avoids the "whistling" which is also a common side issue with smaller breathing holes.

The anterior surface of the breathing hole 9 is contoured and shaped to allow the tongue to sit in the space without irritation and gain some benefit from the physical retention of the tongue, enhancing the airway management.

This process of bringing the tongue and jaw forward causes the airway to open in order to control sleep apnoea. The mouthpiece must be worn continuously during sleep to provide the above benefits. Although the present invention has been described and illustrated with respect to a preferred embodiment; it is not to be limited to this particular embodiment, since modifications and changes can be made therein which are within the full intended scope of the invention.

Claims

CLAIMS: 1. A mouthpiece to control sleep apnoea comprising: a mono-block form of a rigid thermo-formable material having a large breath ing space at the anterior point; an upper U-shaped channel adapted to fit an upper dentition; an lower U-shaped channel adapted to fit a lower dentition; a layer of soft thermo-formable polymer filling the upper and lower U-shaped channels; and a handle for manipulation of the mouthpiece during a fitting process.
2. A mouthpiece to control sleep apnoea according to claim 1, in which the upper and lower U-shaped channels are joined to the mono-block form seam lessly.
3. A mouthpiece to control sleep apnoea according to claim 1, in which a number of nodes protrudes from the layer of soft thermo-formable polymer.
4. A mouthpiece to control sleep apnoea according to claim 1, in which the layer of soft soft thermo-formable fills the upper and lower U-shaped channels with various thickness.
5. A mouthpiece to control sleep apnoea according to claim 1 in which the handle is inserted in the large breathing space.
6. A mouthpiece to control sleep apnoea according to claim 1 in which a tongue can rest in the large breathing space upon removing the handle.
7. A method for controlling sleep apnoea comprising: heating a mouthpiece comprising a mono-block form of a rigid thermo- formable polymer having a large breathing space at the anterior point; an upper U-shaped channel adapted to fit an upper dentition, an lower U-shaped channel adapted to fit the lower dentition, a layer of soft thermo-formable polymer filling the upper and lower U-shaped channels, and a handle for manipulation of the mouthpiece during fitting process, wherein heating continues until the layer of soft thermo-formable polymer filling lower and upper U-shaped channels softens; inserting the mouthpiece into mouth of the user so that the upper and lower dentitions fit in the upper and lower U-shaped channels; imprinting the teeth in the layer of the soft thermo-formable polymer by bitting the mouthpiece whilst moving the lower jaw forward; controlling forward advancement by manipulating fitting handle which rises as result thereof; adapting the layer of soft thermo-formable polymer to teeth by massaging user's cheeks; removing the mouthpiece from user's mouth to cool; allowing the mouthpiece to cool to set the imprints of lower and upper dentitions; removing the handle from the mouthpiece; and wearing the mouthpiece during sleep to control sleep apnoea.
8. A method for controlling sleep apnoea as according to claim 7, in which heating and fitting of the mouthpiece can be done repeatedly.