AU3125199A - A device for preventing or reducing the passage of air through a wearer's mouth - Google Patents

Description

S F Ref: 456293

AUSTRALIA

PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT 0 0 0 *0 ra 0 oa 0000 O 000 0 00 0

ORIGINAL

Name and Address of Applicant: ResMed Limited 82 Waterloo Road North Ryde New South

AUSTRALIA

Wales 2113 Actual Inventor(s): Address for Service: Invention Title: ASSOCIATED PROVISIONAL [31] Application No(s) PP3702 Phillip Kwok and Amal Shirley Amarasinghe Spruson Ferguson, Patent Attorneys Level 33 St Martins Tower, 31 Market Street Sydney, New South Wales, 2000, Australia A Device for Preventing or Reducing the Passage of Air Through a Wearer's Mouth APPLICATION DETAILS [331 Country

AU

[32] Application Date 25 May 1998 The following statement is a full description of this invention, including the best method of performing it known to me/us:- 5815 A DEVICE FOR PREVENTING OR REDUCING THE PASSAGE OF AIR THROUGH A WEARER'S MOUTH FIELD OF THE INVENTION The present invention relates to a device for preventing or reducing the passage of air through a wearer's mouth.

The invention has been developed primarily for use in Continuous Positive Airway Pressure (CPAP) treatment of, for example, Obstructive Sleep Apnea (OSA) and other ventilatory assistance treatments such as Non Invasive Positive Pressure Ventilation (NIPPV) and will be described hereinafter with reference to these applications. However, it will be appreciated that the invention is not limited to these *:foi particular fields of use and also finds application in, for example, assisted respiration, S:mechanical ventilation and the like.

S• BACKGROUND OF THE INVENTION CPAP treatment is a common ameliorative treatment for breathing disorders including OSA. CPAP treatment, as described in US Patent No. 4,944,310, provides pressurised air or other breathable gas to the entrance of a patient's airways at a .pressure elevated above atmospheic pressure, typically in the range 4-20 cm H 2 0.

It is also known for the level of treatment pressure to vary from breath to breath in accordance with patient need, that form of CPAP being known as automatically adjusting nasal CPAP treatment, as described in US Patent No.

5,245,995.

NIPPV is another form of treatment for breathing disorders which can involve a relatively higher pressure of gas being provided in the patient mask during the inspiratory phase of respiration and a relatively lower pressure or atmospheric pressure being provided in the patient 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 ventilatory assistance for CPAP or NIPPV treatment is delivered to the patient 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 of the above described forms of ventilatory treatment or assistance.

[N:\LIBd100495:PVH:DMB 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 conduit or tube, which in turn is connected to a patient 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 servocontroller under the control of a micro controller unit.

A problem experienced by patients undergoing nasal CPAP treatment or non invasive nasal mechanical ventilation 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 ventilatory assistance devices.

These and other problems are discussed in the article "Air Leaking Through •0 15 the Mouth during Nocturnal Nasal Ventilation: Effect on Sleep Quality" by Meya, Thomas J. et al, published in Sleep, Vol. 20, No. 7, 1997 (561-569).

Hitherto, there have been several attempts to solve this problem. One approach uses a chin strap 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 in S0.° 20 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 0000"appears to function in a similar manner to the chin strap described above.

A variation of this approach involves adding a layer of cloth over the lips of 25 the patient. Any air passing through the patient's lips must be forced through the cloth thereby reducing leakage. The device is uncomfortable and still allows air to leak through the patient'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 wearer'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, [N:\L1Bd100495:PVH:DMB -3coughing or speaking if the wearer's nose becomes clogged or other emergency situations arise.

The present applicant's international PCT application No. PCT/AU97/00860 discloses a resilient lips-shaped frame encased in silicon. The frame has an opening through which the lips are pushed to press them together and thus seal the mouth.

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 THE INVENTION Accordingly, in a first aspect, the present invention provides an apparatus for preventing or reducing the passage of air through a wearer's mouth, the apparatus including: a first portion adapted to be adhered above the wearer's upper lip; a second portion adapted to be adhered below the wearer's lower lip; and at least one resilient joining member extending between the first and second S 15 portions, the joining member(s) being adapted to bias the first and second portions and thereby the upper and lower lips together to substantially seal the mouth.

In an embodiment, the first and second portions are separate components.

In another embodiment, the first and second portions are joined to form, or .formed from a single component.

There are preferably two or more joining members extending between the first and second portions. The two joining portions are desirably located approximately **below the wearer's nostrils.

In yet another embodiment, the device also includes a one way valve assembly between the first and second portions and substantially sealed with respect to the wearer's mouth, the valve assembly adapted to allow passage of air only into the mouth.

The first and second portions are preferably produced from cloth, paper, woven fabric or non-woven fabric materials having one side coated with an adhesive.

Commercially available products suitable for the first and second portions include MED 5723 Polyester Nonwoven produced by Avery Dennison (Mfg. Ref 56335), FIXOMULL (Trade Marks) Stretch produced by Beiersdorf Australia Ltd or MEDIPORE or MICROPURE (Trade Mark) surgical tapes produced by 3M Health Care.

The first and second portions desirably have a smooth outer surface to provide an air-tight seal with a nose mask or nose-and-mouth (full-face) mask.

The joining members are preferably produced from: knitted, woven, braided or corded elastic; plastic, metal or composite spring elements; stretchable or resilient fabric; or rubber or other elastomers.

[N:\LIBd00495:PVH:DMB 0 -4- In a further embodiment, the first and second portions are also resilient and integrally formed with the joining members. A commercially available product suitable for resilient first and second portions/joining members is tape model number 9960T produced by 3M Healthcare.

In a second aspect, the present invention provides a device for preventing or reducing the passage of air through a wearer's mouth, the device including: a one way valve assembly adapted to be substantially sealed with respect to the wearer's mouth, wherein the one way valve assembly is adapted to allow passage of air only into the mouth.

The one way valve assembly preferably includes a pair of valve elements having overlapping ends disposed, in use, adjacent the mouth, the outer valve element being relatively stiff and the inner valve element being relatively flexible whereby S "during negative mouth pressurisation the inner valve element flexes away from the outer valve element and towards the mouth to allow air passage through the valve 15 elements into the mouth and during positive mouth pressurisation the inner valve S°element is pressed into a substantially sealed configuration against the outer valve V. element to prevent air passage through the valve elements.

In a third aspect, the present invention provides an apparatus for preventing or S"reducing the passage of air through a wearer's mouth, the apparatus including: S: 20 a first portion adapted to be adhered above a wearer's upper lip; a second portion adapted to be adhered below the wearer's lower lip; :at least one resilient joining member extending between the first and second portions and adapted to bias the first or second portions and thereby the upper and lower lips together to substantially seal the mouth; and 25 a one way valve assembly between the upper and lower portions and adapted to be substantially sealed with respect to the wearer's mouth, wherein one way valve assembly is adapted to allow passage of air only into the mouth.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a front view of a first embodiment of a device according to the first aspect of the invention; Fig. 2 is a front view of a second embodiment of a device according to the first aspect of the invention; Fig. 3 is a front view of a third embodiment of a device according to the first aspect of the invention; Fig. 4 is a front view of a fourth embodiment of a device according to the first aspect of the invention; Fig. 5 is a front view of a fifth embodiment of a device according to the first aspect of the invention; IN:\LI8d]00495:PVH:DMB Fig. 6 is a side view of the fifth embodiment shown in Fig. Fig. 7 is a front view of a first embodiment of a device according to the second aspect of the invention; Fig. 8 is a side view of the embodiment of Fig. 7 along line 8,9-8,9 during positive mouth pressure; Fig. 9 is a side view of the embodiment of Fig. 7 along line 8,9-8,9 during negative mouth pressure; Fig. 10 is a first embodiment of a device according to the third aspect of the invention; Fig. 11 is a side view of the embodiment of Fig. 10 along line 11,12-11,12 during positive mouth pressure; Fig. 12 is a side view of the embodiment of Fig. 10 along line 11,12-11,12 during negative mouth pressure; Fig. 13 is a rear view of a sixth embodiment of a device according to the first 15 aspect of the invention; and ~Fig. 14 is a side view of the embodiment of Fig. 13 along line 14-14.

S DETAILED DESCRIPTION OF THE DRAWINGS Fig. 1 shows a first embodiment of the apparatus 20 for preventing or reducing the passage of air through a wearer's mouth 22 in accordance with the first aspect of this invention.

The apparatus 20 includes a first portion 26 of 3M Healthcare MEDIPORE H surgical tape for adhering above the wearer's upper lip 22U (as shown), a second portion 28 of 3M Healthcare MEDIPORE H surgical tape for adhering below the wearer's lower lip 22L (as shown) and a pair of corded elastic resilient joining S 25 members 30 extending between the first and second portions 26 and 28. The corded elastic is that commonly used by dressmakers.

The joining members 30 each have one end sewn, glued or otherwise attached to each of the first and second portions 26 and 28 and are sized so as to require stretching to enable the first and second portions 26 and 28 to be adhered adjacent their respective lips 22U, 22L when the lips 22U, 22L are in a closed mouth position.

The device 20 is installed by removing the backing strip or "release backing" (not shown) from, for example, the first portion 26 and adhering the first portion above the upper lip 22U. The mouth is then closed, the backing strip of the lower portion 28 removed and the joining members 30 are stretched enough sufficiently to position and adhere the lower portion 28 beneath the lower lip 22L. The resilience in the stretched joining members 30 draws the upper and lower lips together and thereby substantially seals the mouth 22. The lower portion 28 could, of course, be adhered first if desired.

[N:\LIBd]00495:PVH:DMB The primary advantages of the invention are two fold. Firstly, as both of the lips are brought together, a superior seal is created compared to the prior art devices that just attempt to position the lower lip or lower jaw. Secondly, the resilient members 30 can be stretched further to allow opening of the mouth for breathing if the nose becomes blocked or, for example, in (emergency) situations when the wearer may like to cough, breathe through the mouth or speak.

Further embodiments of the first aspect of the invention will now be described with reference to Fig. 2, Fig. 3, Fig. 4, Figs. 5 6 and Figs. 13 14. Like reference numerals to those used to describe the first embodiment shall be used to denote like features in these further embodiments.

A second embodiment of the apparatus 40 is shown in Fig. 2 in which the first and second portions 26 and 28 are shaped to surround the lips 22 so as to increase the available adhesive surface area.

~Fig. 3 shows a third embodiment of the apparatus 50 in which the first and second portions are joined adjacent the edges of the lips 22 and formed from a single piece of material 52. In this embodiment, the material 52 that comprises the first and Ssecond portions is manufactured from a flexible material, for example Tape model number 9906T produced by 3M Healthcare. In other similar embodiments (not shown) o the material 52 is single or multi-layered or formed from overlapping pieces of S" 20 material.

Fig. 4 shows a fourth embodiment of the apparatus 60 manufactured from a single piece of adhesive and also resilient material 62. In this embodiment, the joining members 30 are produced by cutting one or more holes 63 in the material 62 and removing or covering the adhesive from the material 62 in the remaining shaded 25 regions 64.

Fig. 5 and 6 show a fifth embodiment 70 in which the joining members 72 are produced from a resilient material, such as plastic, and include a bent or V-shaped portion 74 which allows the ends to flex apart in the manner of a spring to bias the lips together.

Figs. 13 and 14 show a sixth embodiment of the apparatus 100, similar to the fourth embodiment of the apparatus 60 shown in Fig. 4, manufactured from a single piece of adhesive and also resilient material 62. Tape model number 9906T produced by 3M Healthcare is a suitable material for this application.

This embodiment has six joining members 30 produced by cutting five holes 63 and two slots 108 out of a rectangular piece of material approximately 130mm long and 28mm wide. The six joining members 30 assist in sealing any localised or point leaks betweeen the lips 22U and 22L.

[N:\LIBd00O495:PVH:DMB A side view of the embodiment 100 is shown in Fig. 14, in which the left-hand side is the side exposed to atmosphere and the right-hand side is the side adhered to the wearer's face.

The adhesive or "face" sides of the upper and lower portions 26 and 28 are covered by removable backing strips 110 and 112 prior to fitting. As with earlier embodiments, the backing strips 110 and 112 are removed prior to fitting to expose the adhesive.

The adhesive of "face" sides of the joining members 30 are covered by other strips 114 of the resilient material with their non-adhesive side adjacent the wearer's face to prevent adhesion thereto.

Fig. 7 shows an embodiment of an apparatus 80 for preventing or reducing the passage of air through a wearer's mouth in accordance with the second aspect of the invention.

The apparatus 80 includes a one-way valve assembly 82 adapted to be 15 substantially sealed around the upper and lower lips of the wearer 24 by a peripheral adhesive material portion 83. The one-way valve assembly 82 is comprised of a lower valve element 84 formed from a relatively thin and stiff 0.15 mm thick metal strip that overlaps an upper valve element 86 formed from a relatively resilient 0.40 mm thick rubber strip by about 2.2mm. Other elastomers or flexible materials can be used in 20 place of the rubber strip.

Side views of the apparatus 80 are shown in Figs. 8 and 9. In these views, the left-hand side is the side of the device 80 adhered to the wearer 24, and the right-hand o side is the side of the device 80 exposed to atmosphere. As shown in Fig. 8, when the wearer 24 attempts to breath out, as indicated by arrows 87, the mouth is positively 25 pressurised with respect to the exposed or "non-face" side of the device 80 and the upper strip 86 is pressed into engagement with the lower strip 84 and thereby substantially seals the one-way valve assembly 82 and prevents air from leaving the mouth 22. As shown in Fig. 9, when the wearer 24 attempts to breath in, as indicated by arrows 88, the mouth is negatively pressurised with respect to the exposed or "nonface" side of the device 80 and the upper strip 86 is drawn away from the lower strip 84 thereby allowing passage of air only into the mouth 22 of the wearer 24, as indicated by arrow 89.

The strips can also be manufactured from relatively thicker (lower) and thinner (upper) plastic strips or composites or the like.

Fig. 10 to 12 show an embodiment 90 of the third aspect of the invention, in which features common to embodiments of the first and second aspects are indicated by like reference numerals.

In this embodiment, resilient joining members 30 bias the upper and lower edges of the material portion 83 of the apparatus 90 together to seal the mouth in a fN:\LIBd]00495:PVH:DMB manner akin to the third embodiment of the first aspect and the one-way valve assembly 82 allows the client to breath in only in accordance with the embodiment of the second aspect.

The embodiments of the invention have other advantages over the prior art than those previously mentioned. For example, the embodiments are simple to fit to the wearer's face, do not require chin restraints or neck straps, can be produced in reusable or disposable forms, are inexpensive, have a low profile making them less cumbersome to wear and less prone to dislodgment during movements in sleep and can be used with nasal or full-face masks.

Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention maybe embodied in many other forms.

*0000 o* 09 0• 09* [N:\LIBdOO495:PVH:DMB

Claims (17)

1. An apparatus for preventing or reducing the passage of air through a wearer's mouth, the apparatus including: a first portion adapted to be adhered above the wearer's upper lip; a second portion adapted to be adhered below the wearer's lower lip; and at least one resilient joining member extending between the first and second portions, the joining member(s) being adapted to bias the first and second portions and thereby the upper and lower lips together to substantially seal the mouth.

2. The apparatus as claimed in claim 1, wherein the first and second portions are separate components.

3. The apparatus as claimed in claim 1, wherein the first and second portions are joined to form a single component.

4. The apparatus as claimed in claim 1, wherein the first and second Sparties are formed from a single component. 15

5. The apparatus as claimed in claim 2, 3 or 4, including two joining members extending between the first and second portions.

6. The apparatus as claimed in claim 5, wherein the two joining portions are located approximately below the wearer's nostrils.

7. The apparatus ag claimed in any one of claims 1 to 6, wherein the device also includes a one way valve assembly between the first and second portions and substantially sealed with respect to the wearer's mouth, the valve assembly adapted to allow passage of air only into the mouth.

8. The apparatus as claimed in any one of claims 1 to 7, wherein the first and second portions are produced from cloth, paper, woven fabric or non-woven fabric 25 materials having one side coated with an adhesive.

9. The apparatus as claimed in any one of claims 1 to 8, wherein the first and second portions have a smooth outer surface to provide an air-tight seal with a nasal mask or nose-and-mouth (full-face) mask.

The apparatus as claimed in any one of claims 1 to 9, wherein the joining members are produced from: knitted, woven, braided or corded elastic; plastic, metal or composite spring elements; stretchable or resilient fabric; or rubber or other elastomers.

11. The apparatus as claimed in any one of claims 1 to 10, wherein the first and second portions are also resilient and integrally formed with the joining members.

12. A device for preventing or reducing the passage of air through a wearer's mouth, the device including: [N:\LIBd00495:PVH:DMB a one way valve assembly adapted to be substantially sealed with respect to the wearer's mouth, wherein the one way valve assembly is adapted to allow passage of air only into the mouth.

13. The device as claimed in claim 12, wherein the one way valve assembly includes a pair of valve elements having overlapping ends disposed, in use, adjacent the mouth, the outer valve element being relatively stiff and the inner valve element being relatively flexible whereby during inhalation the inner valve element flexes away from the outer valve element and towards the mouth to allow air passage through the valve elements into the mouth and during attempted exhalation the inner valve element is pressed into a substantially sealed configuration against the outer valve element to prevent air passage through the valve elements.

14. The device as claimed in claim 13, wherein the outer valve element is formed from 0.15mm thick metal strip and the inner valve element is formed from S 0.40mm thick rubber strip.

15 15. An apparatus for preventing or reducing the passage of air through a wearer's mouth, the apparatus including: a first portion adapted to be adhered above a wearer's upper lip; a second portion adapted to be adhered below the wearer's lower lip; at least one resilient joining member extending between the first and second 20 portions and adapted to bias the first or second portions and thereby the upper and lower lips together to substantially seal the mouth; and a one way valve assembly between the upper and lower portions and adapted to "be substantially sealed with respect to the wearer's mouth, wherein one way valve assembly is adapted to allow passage of air only into the mouth. 25

16. An apparatus for preventing or reducing the passage of air through a wearer's mouth, said apparatus substantially as described herein with reference to Figs: 1; 2; 3; 4; 10 to 12; or 13 and 14 of the accompanying drawings.

17. A device for preventing or reducing the passage of air through a wearer's mouth, said device substantially as described herein with reference to Figs: 7 to 9; or 10 to 12 of the accompanying drawings. DATED this Twenty-Fifth Day of May 1999 ResMed Limited Patent Attorneys for the Applicant/Nominated Person SPRUSON FERGUSON [N:\LIBd]0495:PVH:DMB