Mouthpiece with bendable extra-oral sealing means

Abstract: A mouthpiece for oral delivery for oral delivery of CPAP treatment has a vestibular shield for location between the teeth and lips/cheeks of a wearer. The vestibular shield is dimensioned to extend laterally into the buccal vestibule and vertically to overlap the gums. The vestibular shield is formed from a very supple material. A gases pathway is provided through the vestibular shield and may include a hard plastic insert through the shield, including a standard breathing conduit connection at its outer end. A short stub conduit on the outlet side of the shield passes between the wearers upper and lower teeth. A connection for connecting the mouthpiece to a breathing circuit is also provided which reduces the transfer of forces caused by movement therebetween. The connection may include a short length of highly flexible gases conduit, an elbow and a swivel connection.

Description: This invention relates to a novel mouthpiece for the oral delivery of air in continuous positive airway pressure (CPAP) treatments of sleeping disorders such as sleep apnoea. Description of the Prior Art Sleep apnoea treatments have been significantly advanced with the introduction of continuous positive airway pressure (CPAP) treatments. These treatments, as introduced, involve the supply of gases from a gases supply or blower to a patient through a conduit and nasal mask to provide an elevated internal pressure in the users airways to assist the muscles to keep the airways open. This airstream is provided to the user through a nasal mask applied over the nose and held in place by a harness. This configuration has been almost universally adopted based on the well known observation that humans show a decided preference for nasal breathing during sleep. For this reason, little development has been undertaken into other possible methods of providing the pressurized airstream to a user. Oral delivery is suggested in EP 818, 213, which shows an apparatus for oral delivery of air in a CPAP treatment. The apparatus includes a mouthpiece adapted to fit inside the mouth between the roof of the mouth, the hard palate, and the tongue, and having a periphery which can be gripped between the teeth. It is thought by the applicants that this is significantly more intrusive than is necessary and is liable to movement and consequent discomfort (although not outright removal) under the relaxation of sleep. It has the additional disadvantage that with the user fully relaxed, such as in the case of sleep, a distension in the user's jaw and subsequent opening of the mouth can reduce the sealing effectiveness of the mouthpiece and reduce the efficacy of the CPAP treatment. Because the mouthpiece in EP 818,213 is gripped between the user's teeth, a further disadvantage results in that the mouthpiece requires custom orthodontic fitting to ensure that the mouthpiece matches the user's mouth and teeth layout. Custom orthodontic fitting is time consuming and removes the capability of effective mass manufacture. Consequently, the mouthpiece in EP 818,213 is expensive, creating a significant barrier to the patient adoption of the device. A similar gases delivery mouthpiece, for use with a respirator, is shown in WO 90/03199. WO 90/03199 discloses an orthodontic device which is adapted to be gripped between the jaws of a user and to accommodate the user's teeth within a series of upper and lower cavities. A base member of the mouthpiece is shaped and fits against the hard palate of the user. This mouthpiece again has the disadvantage of requiring custom orthodontic fitting. Furthermore, as a result of the mouthpiece's substantial thickness and size, the mouthpiece is substantially rigid in the vestibule regions of the mouth. The mouthpiece is clamped in place by an outer shield which engages the outside of the user's lips. A paper by E Veres entitled "Clinical trial of an oral vestibular shield for the control of snoring" (Journal of the Dental Association of South Africa, January 1993) describes the use of a shield intended to be retained in the vestibule of the mouth to seal the mouth and to promote nasal breathing which has been conventionally considered to be more beneficial than oral breathing. Humidified CPAP treatments delivered orally, however, actually derive greater benefit than those delivered nasally because secondary leakage through the nasal passages during oral delivery is significantly less than oral leakage during nasal delivery. The shield depicted in the paper is formed from flexible ethylene vinyl. The shield is custom trimmed and is custom fitted by heating to a malleable temperature and deformed by applied pressure. Other possible mouthpiece designs are shown for example by use in self contained underwater breathing apparatus systems, for example as depicted in United States Patent No. 4,862,909. This mouthpiece is a mouth guard type and is clamped between the teeth. A flange extends both in front of and behind the teeth. US3,139,088 discloses an oral inhaler and mouthpiece having a pair of lip sealing plates. The plates engage with a patient's lips when adjusted along the mouthpiece. US3,882,860 discloses a resuscitation device having two flanges. One of the flanges is laid between the teeth and lips of the patient and the other is slideably arranged to press and fixed on the patient's lips by means of a clamping or arresting device. Prior art mouthpieces are not well adapted for use in CPAP treatments because they are intended for conscious gripping by the user, and have been found subject to accidental removal with a user in a completely relaxed state such as sleep. The present invention overcomes this problem and present several other advantages which will become apparent upon a reading of the attached specification, in combination with a study of the drawings. SUMMARY OF THE INVENTION It is an object of the present invention to provide a mouthpiece for oral delivery of gases, which goes some way toward overcoming the above disadvantages or which will at least provide the public with a useful choice. The present invention consists in a mouthpiece as defined in claim 1. The mouthpiece of the invention comprises: a vestibular shield having an inner surface and an outer surface, said vestibular shield having a predetermined height which will overlap a user's teeth and gums when positioned in the mouth vestibule of a user; gases passageway means extending from said outer surface of said vestibular shield to said inner surface of said vestibular shield for allowing the passage of said gases through said mouthpiece; and extra-oral sealing means associated with said gases passageway or said vestibular shield said extra-oral sealing means capable of being flexed into one of two configurations, a first condition when said mouthpiece is inserted into a user's mouth being substantially unengaged with a user's face, and a second condition when correctly positioned in a user's mouth being substantially engaged with a user's face and under compression thereupon. To those skilled in the art to which the invention relates, many changes in construction and widely differing embodiments and applications of the invention will suggest themselves without departing from the scope of the invention as defined in the appended claims. The disclosures and the descriptions herein are purely illustrative and are not intended to be in any sense limiting. The invention consists in the foregoing and also envisages constructions of which the following gives examples. BRIEF DESCRIPTION OF THE DRAWINGS One preferred form of the present invention will now be described with reference to the accompanying drawings in which; Figure 1 is a side elevational view of a system which may be used by a patient, Figure 2 is a perspective view from above of a mouthpiece according to the preferred embodiment of the present invention, Figure 3 is a perspective view from one side and from an inward direction of the mouthpiece of Figure 2, Figure 4 is a cross-section of the mouthpiece of Figure 2, Figure 5 is a cross-sectional view of the mouthpiece of Figure 2 and a user with the mouthpiece in place to demonstrate the location and positioning thereof in relation to the main features of the user's anatomy, Figure 6 is a perspective view of the mouthpiece with the outer flap in place, Figure 7 is a perspective view of the outer flap bent back, Figure 8 is a cutaway view of the present invention with the outer flap in use, Figure 9 is a perspective view of the outer flap including the ventilation apertures and moisture barrier, and Figure 10 is a block diagram of a respiratory system according to the preferred embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS While the invention may be susceptible to embodiment in different forms, there is shown in the drawings, and herein will be described in detail, specific embodiments with the understanding that the present disclosure is to be considered an exemplification of the principles of the invention, and is not intended to limit the invention to that as illustrated and described herein. The present disclosure describes a system for oral delivery of gases pressurised above ambient to a user and is especially suited for use in the oral delivery of air in continuous positive airway pressure (CPAP) treatments of sleeping disorders such as sleep apnoea. As shown in Figure 1, the system includes a mouthpiece which is connected by a connection 40 to a breathing circuit 41. A preferred embodiment of the present invention is illustrated in Figures 2 to 5. In this embodiment, the mouthpiece 50 includes a vestibular shield 2 being a generally flat and generally rectangularly-shaped member in front elevation having a curved profile that reflects the curvature of a user's jaw and in turn the curvature of the labial vestibule region. A gases passageway extends through the vestibular shield from an inlet 51 to an outlet 52 in much the same way as with the earlier embodiments. In the preferred embodiment the inlet 51 is provided by a flattened oval-shaped connector 53. The outlet 52 has an even more laterally extended flattened oval shape 54. The major differences between the mouthpiece 50 and the embodiments described above are provided on the inner face of the vestibular shield. Most prominently, the mouthpiece 50 includes a tongue depressor 55 extending from the inner face of the vestibular shield 2. The operation of the tongue depressor will be described further on with reference to Figure 5. The tongue depressor includes a vertical stiffening flange 56 centrally located on its upper surface and extending from the gases outlet 52. In use gases flow easily around the stiffening flange 56 effectively bifurcating the gases outlet 52. The tongue depressor 55 further includes a pair of vertically extending spacers 57 which in use may abut against the roof of the wearer's mouth and ensure that the tongue cannot completely block the air passageway. In the mouthpiece 50 the sealing effect of the vestibular shield 2 against the lips of the user is enhanced by providing teeth abutments of significantly increased thickness than the raised area 20 of the earlier embodiments. In particular, an upper teeth abutment 58 and a lower teeth abutment 59 are provided, with the lower teeth abutment 59 protruding further from the inner face of the vestibular shield 2 than the upper teeth abutment 58. This difference serves to match the typical over-bite of most users. The abutments 58 and 59 are not required to be wider than the gases outlet 52. A notch 60 is provided centrally in the upper edge of the vestibular shield 2 to accommodate the upper frenal attachment. A slight bead 61 is provided around the edge of the vestibular shield 2 for user comfort, with the vestibular shield 2 otherwise being very thin for additional suppleness. Referring particularly to Figure 4, in its preferred form the mouthpiece 50 is preferably formed by over-moulding a soft and supple material part 70 over a stiffer material part 67. These can generally be termed the shield part and the passageway-forming insert. The passageway-forming insert preferably includes a pair of upper and lower vertical flanges 63 and 64 to fully engage within the supple material. The passageway-forming insert 67 includes the vertically extending stiffening flange 56 of the tongue depressor 55, together with a curved planar portion 71 forming the backbone of the tongue depressor 55. The vertically extending spacers 57 are of the soft and supple material and are part of the over-moulding 70, as are the upper and lower teeth abutments 58 and 59. Referring now to Figure 5, use of the mouthpiece according to Figures 2 to 4 is depicted. With the present mouthpiece 50, the upper and lower lips 5, 6 are further distended by the abutment action of the abutments 75, 76 against the upper and lower teeth 7, 8 respectively, thus forming a seal of greater pressure between the lips 5, 6 and the upper and lower portions respectively of the vestibular shield 2. A lower face 77 of the tongue depressor 55 impinges if necessary on the upper surface 72 of the tongue 25 and retains the tongue in the lower portion of the mouth. This ensures a clear gases outlet 52 from the gases passageway through the vestibular shield. The vertically extending spacers 57, if forced by pressure from the tongue, will engage against the roof of the user's mouth and maintain a clear air passageway. This stops the sleeping patient unconsciously blocking the oral passageway and reverting to nasal breathing. Attention is now directed to Figure 1. It has been found that an additional factor in the effectiveness of any mouthpiece, including mouthpiece 1, is the manner in which the mouthpiece is connected to the breathing circuit 41. The weight of the breathing circuit 41, and any attempted movement of one other of the breathing circuit 41 and the mouthpiece 1 relative to the other, is one of the largest influences tending to dislodge a mouthpiece 1 from the mouth of a user. It must be noted that the mouthpiece 1 must remain in position and maintain a seal during all sleep, when the user has no muscle tone. The connection 40 as provided in the present invention between the breathing circuit 41 and the mouthpiece 1 decouples the mouthpiece 1 from the breathing circuit 41. As a result, the connection 40 is effective in reducing the forces placed on the mouthpiece 1 by the breathing circuit 41 when the user moves around during sleep. In the preferred sleeping position, the breathing circuit 41 is laid across the chest 43 of the user, and may be secured to the user's bed clothes or sleeping garments. The breathing circuit 41 is preferably laid on the chest of the user to take the weight of the breathing circuit 41 off of the mouthpiece 1. To connect between the gases outlet 14 which is vertical when the user is laying on his or her back and the breathing circuit 41 which is generally horizontal, an L-shaped elbow 45 is incorporated in the connection 40. The elbow 45 may be incorporated in the mouthpiece 1, however, it is preferred that the mouthpiece 1 be kept small to provide for easier cleaning. The elbow 45 is formed at a right angle and provides a positive pressure on the mouthpiece 1 to maintain the mouthpiece 1 in the user's mouth. The elbow 45 may include a swivel joint and may be disconnected from gaseous outlet 14. The connection 40 further includes an extremely flexible connecting tube 46 provided between the elbow 45 and the breathing circuit 41. The connecting tube 46 is preferably connected to the breathing circuit 41 by a swivel joint 48 for reasons described herein. The breathing circuit 41, while flexible, will necessarily be stiff enough to maintain its integrity over comparatively long tuns, while the connecting tube 46, being only a short length, for example 10 centimetres, merely has to span between the user's mouth and chest, and can thereby be made in a manner that would not be suitable for long runs. Furthermore, as a result of the short length of the connecting tube 46, the connecting tube 46 does not need to incorporate significant insulation or heating capability. The connecting tube 46 may be formed from a thin plastic membrane supported over a helical or double helical or corrugated supporting ribs. In such a case, the support makes the connection tube 46 laterally flexible and resistant to torsion. The elbow swivel joint 45 allows for movement of the connection tube 46 relative to the mouthpiece 1. The swivel joint 48 allows for movement of the connection tube 46 relative to the breathing circuit 41. It is to be understood that one or both of the swivel joints 45, 48 could be eliminated, but the preferred embodiment includes swivel joint 48. Referring now to Figure 6 of the present invention is illustrated including an extra-oral sealing flap 100. The flap 100 in its natural bias is tapered, the wide open end of which is shaped to conform to the facial contours around the outside of the mouth of a user. The narrow end joins to a cylindrical section, which is designed to slide over the inlet port 104 of the mouthpiece 102. While this is one method of attachment the flap 100 might also be constructed as an integral part of the mouthpiece 102. The flap 100 needs to be constructed of flexible material, therefore materials such as silicone rubber can be employed to fashion the flap. The outer flap 100 is seen in Figure 7, in a bent back position. It will be appreciated that when the mouthpiece 102 is being inserted into the mouth of a user, the outer flap 100 is intended to be in this bent back position to aid insertion. Prior to insertion, the outer flap is bent back by simply pressing on its outer periphery 106, until it snaps into the bent back position, in which it will stay unaided. In Figure 8 we see the outer flap 100 in use with the mouthpiece 102 in the mouth 107 of a user 110. Once correctly positioned in the mouth 106, the outer flap 100 may be adjusted into its operational position by pressing on its outer periphery 106 until it snaps back to press against the outside of the mouth 108. Due to the relative position of the vestibular shield 112 and the outer flap 100, the outer flap 100 is unable to fully reach its natural bias and thereby inflicts a compressive force on the outside of the mouth 108. It will be appreciated that as well as providing a substantially airtight seal the addition of the outer flap provides enough compressive force on the mouth to keep the mouthpiece and conduit in place without the need for straps. This allows the administering of CPAP therapy to be considerably less obtrusive than traditional methods. In a further additional improvement shown in Figure 9, the outer flap 300 is shown in perspective. Included are ventilation apertures 302, 303 either side of the gases port 304, which are surrounded by a ridge 306 acting as a moisture barrier. The apertures 302,303 are provided such that any excess moisture leaking from the mouth will migrate to the apertures where they may evaporate. Small vents in the conduit may be used to direct small amounts of pressurised gas at the apertures to aid evaporation. The ridge 306 is included to ensure that no moisture migrates further into the sealing region 308, as this would be detrimental to the sealing properties of the flap. A typical respiratory humidification circuit such as might employ the present invention is shown diagrammatically in Figure 10, and includes the respirator 230, humidifier 231, and the associated respiratory breathing tubes 233 and 234. A patient 236 under treatment is shown, with the present invention 237, located in the mouth of the patient 236. From the above it can be seen that the present invention provides a mouthpiece 1 for oral delivery of CPAP treatment which at once is low cost and effective. Unlike other appliances the mouthpiece 1 used in the present invention does not require custom orthodontic fitting as the mouthpiece 1 does not rely on accurate alignment with the user's teeth or the user's palate to provide location and retention within the user's mouth, but instead resides in the vestibule between the teeth and lips and the teeth and cheeks, and the lateral and vertical extension of the vestibular shield 2 requires that the user's lips be actively manipulated for the vestibular shield 2 to be removed. Furthermore the improved connection 40 to the breathing circuit 41 reduces the forces which tend to pull at the mouthpiece 1. With the addition of the extra-oral flap 100, the mouthpiece and associated tubing is held securely in place without the need for external strapping, and an effective seal is created around the users mouth.

Claims: A mouthpiece (102) for delivering gases to the oral cavity of a user (110) comprising: a vestibular shield (112) having an inner surface and an outer surface, said vestibular shield (112) having a predetermined height which will overlap a user's teeth and gums when positioned in the mouth vestibule of a user; gases passageway means (53) extending from said outer surface of said vestibular shield (112) to said inner surface of said vestibular shield (112) for allowing the passage of said gases through said mouthpiece (102); and extra-oral sealing means (100) associated with one of said gases passageway (53) and said vestibular shield (112) characterised in that said extra-oral sealing means (100) is capable of being flexed into one of two configurations, a first condition when said mouthpiece (102) is inserted into a user's mouth with said extra-oral sealing means substantially unengaged with a user's face, and a second condition when correctly positioned in a user's mouth with said extra-oral sealing means (112) substantially engaged with a user's face and under compression thereupon. A mouthpiece as claimed in claim 1 wherein said mouthpiece (102) further includes a central portion which will extend over a user's front teeth and gums when said central portion is positioned between the lips and teeth of said user, and outer portions (4) extending from said central portion which extend along and overlap at least a portion of the user's back teeth and gums when said outer portions are postioned between the cheeks and teeth of the user and a raised portion (58) provided on said inner surface of said central portion of said vestibular shield, said raised portion solely contacting the teeth of a user when said vestibular shield (112) is placed in the mouth of a user. A mouthpiece as claimed in claim 2 wherein said raised portion (58) is of a generally flattened oval shape. A mouthpiece as claimed in claim 2 wherein said raised portion (58) extends along at least a portion of said outer portions (4). A mouthpiece as claimed in claim 1 wherein said central portion includes a centrally located notch (60) in a top edge thereof. A mouthpiece as claimed in claim 1 wherein said vestibular shield (112) has a generally curved profile. A mouthpiece as claimed in claim 1 wherein said gases passageway means (53) includes gases inlet means (51) for allowing connecting of said mouthpiece (102) to a gases supply (230). A mouthpiece as claimed in claim 1 wherein said gases inlet means (51) is connected to said central portion of said vestibular shield (112). A mouthpiece as claimed in claim 1 wherein said vestibular shield (112) is formed of a supple material and said gases inlet means (51) comprises a tube formed of a stiffer material than said supple material that is used to form said vestibular shield, said tube being attached to said vestibular shield. A mouthpiece as claimed in claim 1 wherein said gases passageway means (53) includes gases outlet means (52) for allowing gases to be expelled into the mouth of a user. A mouthpiece as claimed in claim 10 wherein said gases outlet means (52) is provided along said central portion of said vestibular shield (112). A mouthpiece as claimed in claim 11 wherein said gases passageway means (53) includes gases inlet means (51) for allowing connection of said mouthpiece to a gases supply. A mouthpiece as claimed in claim 12 wherein said gases outlet means (52) is aligned with said gases inlet means (51). A mouthpiece as claimed in claim 13 wherein said gases inlet means (51) and said gases outlet means (52) are connected to said central portion of said vestibular shield (112). A mouthpiece as claimed in claim 14 wherein said gases outlet means (52) is a generally flattened oval-shaped tube which extends from said inner surface of said vestibular shield (112). A mouthpiece as claimed in claim 15 wherein said outer portions (4) of said vestibular shield (112) include a plurality of ribs thereon. A mouthpiece as claimed in claim 1 wherein said ribs are provided on said outer surface of said vestibular shield (112). A mouthpiece as claimed in claim 1 wherein said vestibular shield (112) is formed of a supple material. A mouthpiece as claimed in claim 1 wherein said vestibular shield (112) is generally flat. A mouthpiece as claimed in claim 1 wherein each said outer portion (4) has rounded upper and lower edges. A mouthpiece as claimed in claim 2 wherein said raised portion (58) includes an upper abutment portion (58) for abutting against the upper teeth and a lower abutment portion (59) for abutting against the lower teeth and the lower abutment portion (59) is raised further from the inner surface of the vestibular shield (112) than said upper abutment portion (58). A mouthpiece as claimed in claim 1 including a tongue depressing guard (55) extending from the inner side of said vestibular shield (112). A mouthpiece as claimed in claim 22 wherein said tongue depressor (55) has a concave curve in its lower surface and is stiffer than the outer portions (4) of said vestibular shield (112). A mouthpiece as claimed in claim 23 wherein said mouthpiece (102) including one or more vertically extending spacers (57) projecting from the upper surface of said tongue depressing guard (55). A mouthpiece as claimed in claim 24 wherein said gases passageway (53) is provided by an insert of substantially stiffer material than the material of said vestibular shield (112), said insert extending through said vestibular shield, and said tongue depressing guard (55) includes therein an extension of said insert forming a stiff backbone (71) therefor. A mouthpiece as claimed in claim 1 wherein said extra-oral sealing means (100) are detachable from said gases passageway (53). A mouthpiece as claimed in claim 1 wherein said extra-oral sealing means (100) are constructed of silicon rubber. A mouthpiece as claimed in claim 1 wherein said extra-oral sealing means (100) comprise at least one tapered flap (100). A mouthpiece as claimed in claim 28 wherein said flap (100) has a wide end and a narrow end, said narrow end being attached to said gases passageway (53). A mouthpiece as claimed in claim 29 wherein said first condition comprises said wide end being distal to a user relative to said narrow end being proximal to a user. A mouthpiece as claimed in claim 30 wherein said second condition comprises said wide end being proximal to a user relative to said narrow end being distal to a user. A mouthpiece as claimed in claim 1 wherein the compressive force between said vestibular shield (112) and said extra-oral sealing means (100) on the area surrounding a user's lips is sufficient to secure said mouthpiece (102) in place on a user and to provide a substantial seal thereto. A mouthpiece as claimed in claim 29 wherein said wide end is adapted to conform to the facial contours of a user. A mouthpiece as claimed in claim 28 wherein said flap (100) includes at least one ventilation means (303), proximal to said narrow end. A mouthpiece as claimed in claim 34 wherein said narrow end and said at least one ventilator means (303) are surrounded by a ridge (306) on the side of said flap (100) which in use faces a user. A mouthpiece as claimed in claim 34 wherein said at least one ventilator means (303) comprises two apertures either side of said narrow end. A mouthpiece as claimed in claim 36 wherein said mouthpiece includes means which are adapted to direct a small amount of pressurised gases in the vicinity of said apertures.

Inventors: GRADON LEWIS GEORGE, ROBERTSON CHRISTOPHER JOHN, SMITH NICHOLAS CHARLES ALAN, GRADON, LEWIS GEORGE, ROBERTSON, CHRISTOPHER JOHN, SMITH, NICHOLAS CHARLES ALAN
Applicants: FISHER & PAYKEL HEALTHCARE LTD, FISHER & PAYKEL HEALTHCARE LIMITED
Application year: 2000
Main classification: A61M16
IPC codes: A61M16