Self-Retaining Oral Device

Abstract

A mouthpiece includes a buccal retention feature that produces frictional attachment to the lateral buccal portions (inner cheeks) of the individual user. The mouthpiece includes a U-shaped body sized and shaped to conform to the outer face of the dental arch. The retention feature includes bulbous protrusions that project laterally outward from the body to engage the cheek. The mouthpiece, and particularly the buccal retention feature, has a width that is large enough to prevent dislodgment or removal of the device from the mouth, taking advantage of the decrease in the intercommissural distance as the mouth is opened to attempt to remove the device. The device further includes a duct portion extending forward, outside the mouth, from the body, to permit normal respiration through the duct portion. The duct portion can be configured to connect to other devices, including but not limited to, devices for rebreathing, suctioning, feeding or delivering medicaments.

Claims

1. A mouthpiece comprising: a U-shaped body configured to seat against the outer face of the dental arch of a person when the mouthpiece is in the mouth of the person; an opening defined in said U-shaped body in communication with the oral cavity of the person when the U-shaped body is seated against the outer face of the dental arch; and a buccal retention portion configured for frictional engagement with the lateral buccal portions (inner cheeks) of the person.

2. The mouthpiece of claim 1, wherein: the U-shaped body includes opposite arms arranged to be positioned between the dental arch and the lateral buccal portions of the person; and the buccal retention portion includes a bulbous protrusion on each of the opposite arms, protruding laterally outward from the U-shaped body into contact with the lateral buccal portions of the person.

3. The mouthpiece of claim 2, wherein the mouthpiece has a lateral width spanning the bulbous protrusions, the lateral width being greater than the intercommissural distance of the person's mouth when the mouth is at least partially open.

4. The mouthpiece of claim 2, wherein the bulbous protrusions include friction enhancing surface features defined on an outer surface of said protrusions facing the lateral buccal portion of the person.

5. The mouthpiece of claim 4, wherein the surface features include treads that are vertically arranged relative to a lateral width of the mouthpiece spanning the bulbous protrusions, and are fore-aft spaced apart in relative to the lateral width of the mouthpiece to define valleys therebetween.

6. The mouthpiece of claim 5, wherein the U-shaped body defines an opening in each of the opposite arms in fluid communication with the valleys defined between the treads.

7. The mouthpiece of claim 5, wherein the bulbous protrusions further define a fore-aft channel through the treads.

8. The mouthpiece of claim 1, further comprising a duct portion extending from said U-shaped body away from the dental arch when the mouthpiece is in the mouth of the person, the duct portion defining at least one channel in fluid communication with said opening and extending to a second opening outside the mouth of the person.

9. The mouthpiece of claim 8, wherein said duct portion includes a septum extending along a length of the duct portion to define two adjacent channels.

10. The mouthpiece of claim 8, wherein said duct portion includes a curved portion between said opening and said second opening, said curved portion curved downward from said opening over the chin of the person when the mouthpiece is in the mouth of the person.

11. The mouthpiece of claim 10, wherein said duct portion includes an interface portion between said opening and said curved portion, said interface portion sized to extend the curved portion away from the chin of the person when the mouthpiece is in the mouth of the person.

12. The mouthpiece of claim 8, wherein said U-shaped body, said buccal retention portion and said duct portion are integrally formed as one piece.

13. The mouthpiece of claim 1, wherein said U-shaped body and said buccal retention portion are integrally formed as one piece.

14. The mouthpiece of claim 2, wherein said U-shaped body is formed of a resiliently pliant material so that the opposite arms can be manually pinched towards each other.

15. The mouthpiece of claim 14, wherein said material is silicone.

16. The mouthpiece of claim 1, further comprising a tooth engagement portion arranged to contact one or more teeth of the person when the device is inside the person's mouth.

17. The mouthpiece of claim 16, wherein: the U-shaped body includes opposite arms arranged to be positioned between the dental arch and the lateral buccal portions of the person; and the tooth engagement portion includes a wing disposed on each of said opposite arms and projecting laterally inward into the oral cavity of the person when the device is inside the person's mouth, the wing arranged on the U-shaped body to contact at least one of the molars of the person.

18. A breathing apparatus for increasing the partial pressure of carbon-dioxide (CO.sub.2) in the blood of a subject (pCO.sub.2), comprising: a mouthpiece according to claim 1; and a rebreathing device mounted to and carried by said mouthpiece including; a chamber in fluid communication with the opening of said mouthpiece and at least one outlet through which gas flows as the subject inhales and exhales; and an enlarged dead space between the opening of said mouthpiece and said at least one outlet, the dead space defining a volume sized to retain a predetermined portion of the CO.sub.2 exhaled by the subject to be inhaled or re-breathed by the person on the next inhalation.

19. A breathing apparatus for increasing the partial pressure of carbon-dioxide (CO.sub.2) in the blood of a subject (pCO.sub.2), comprising: a mouthpiece according to claim 8; and a rebreathing device mounted to and carried by said duct portion of said mouthpiece including; a chamber in fluid communication with said second opening of said duct portion and at least one outlet through which gas flows as the subject inhales and exhales; and an enlarged dead space between the opening of said mouthpiece and said at least one outlet, the dead space defining a volume sized to retain a predetermined portion of the CO.sub.2 exhaled by the subject to be inhaled or re-breathed by the person on the next inhalation.

20. The breathing apparatus of claim 18, wherein the volume of the dead space is sized in relation to the tidal volume of air displaced by the subject during inhalation and exhalation to be approximately 10 to 50% of the tidal volume of the subject.

21. The breathing apparatus of claim 18, wherein the volume of the dead space is adjustable.

22. An apparatus comprising: a mouthpiece according to claim 1; and a tube fluidly connected between said opening of said mouthpiece and an apparatus for one or more of oxygen delivery, gaseous medicament delivery (anesthesia agents), endotracheal devices and feeding devices.

23. An apparatus comprising: a mouthpiece according to claim 8; and a tube fluidly connected between said second opening of said duct portion of said mouthpiece and an apparatus for one or more of oxygen delivery, gaseous medicament delivery (anesthesia agents), endotracheal devices and feeding devices.

Description

DESCRIPTION OF THE DRAWINGS

[0016] FIG. 1 is a front perspective view of a mouthpiece according to one embodiment of the present disclosure.

[0017] FIG. 2 is a top view of the mouthpiece shown in FIG. 1.

[0018] FIG. 3 is a side perspective view of the mouthpiece shown in FIG. 1.

[0019] FIG. 4 is a rear view of the mouthpiece shown in FIG. 1.

[0020] FIG. 5 is a side view of the mouthpiece shown in FIG. 1.

[0021] FIG. 6 is a side cross-sectional view of the mouthpiece shown in FIG. 1.

[0022] FIG. 7 is a sectioned view of the mouthpiece shown in FIG. 1.

[0023] FIG. 8 is a front perspective view of a breathing apparatus including the mouthpiece of FIG. 1 according to one aspect of the present disclosure.

[0024] FIG. 9 is a rear perspective view of the breathing apparatus shown in FIG. 8.

[0025] FIG. 10 is a side exploded partial cross-sectional view of the breathing apparatus shown in FIG. 8.

[0026] FIG. 11 is a diagram of the dimensions of the mouth of a human.

[0027] FIG. 12 is a chart showing zones of inspiration and expiration of a human.

[0028] FIGS. 13A-13C are depictions of a mouthpiece-type breathing apparatus according to the present disclosure.

[0029] FIGS. 14A-14B are depictions of another mouthpiece-type breathing apparatus according to the present disclosure.

[0030] FIG. 15 is a depiction of a mouthpiece-type breathing apparatus having an adjustable dead space volume according to the present disclosure.

[0031] FIG. 16 is a depiction of another mouthpiece-type breathing apparatus having an adjustable dead space volume according to the present disclosure.

[0032] FIG. 17 is a depiction of an alternative mouthpiece-type breathing apparatus having an adjustable dead space volume according to the present disclosure.

[0033] FIG. 18 is a depiction of yet another mouthpiece-type breathing apparatus having an adjustable dead space volume according to the present disclosure.

[0034] FIG. 19 is a depiction of a further mouthpiece-type breathing apparatus having an adjustable dead space volume according to the present disclosure.

[0035] FIGS. 20A-20B are depictions of a further mouthpiece-type breathing apparatus having an adjustable dead space volume according to the present disclosure.

[0036] FIG. 21A-21B are depictions of a mouthpiece-type breathing apparatus having an adjustable dead space volume according to the present disclosure.

DETAILED DESCRIPTION

[0037] For the purposes of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiments illustrated in the drawings and described in the following written specification. It is understood that no limitation to the scope of the disclosure is thereby intended. It is further understood that the present disclosure includes any alterations and modifications to the illustrated embodiments and includes further applications of the principles disclosed herein as would normally occur to one skilled in the art to which this disclosure pertains.

[0038] A mouthpiece device 10 shown in FIGS. 1-7 utilizes an oral retention mechanism referred to herein as buccal retention. The device includes a tooth engagement portion 12 that can rest on or against the teeth of the person and a buccal retention portion 14 that is configured to be gripped by the cheeks of the individual, with both retention mechanisms being explained in more detail herein. The device includes a duct portion 16 that opens into the mouth cavity to allow the person to breathe through the device.

[0039] The device 10 includes a U-shaped body 20 that is sized to fit outside the teeth or on the outer surface of the dental arch of the person. The tooth engagement portion, buccal retention portion and duct portion are all preferably integral and in one piece with the body 20. The body includes a pair of arms 20a, 20b that are situated at the lateral sides of the dental arch, joined by a center section 20c disposed at the front of the dental arch when the device is in the person's mouth. The body 20 includes an interior surface 21 that is adapted to bear against the outer face of the gums and the dental arch, or teeth, of the person. It can be appreciated that the size of the body 20 is determined by the size of the mouth of the person so that the device 10 can be comfortably placed and retained within the person's mouth. The material of the device 10 is also adapted for comfort so that the person is not motivated by pain or discomfort to remove the device. Thus, in one embodiment the device 10 is formed from a suitable polymer, and more specifically silicone with sufficient compliance to be comfortable to the person and sufficient rigidity to hold its shape after length and repeated use.

[0040] The body 20 can include upper lobes 23 and lower lobes 24 that are arranged to contact the gums. The upper lobes 23 can be provided with surface features 23a, such as transverse ridges, that contact the inside of the person's upper lip when the device is in place. The lobes 23, 24 are configured to increase the surface area of the device contacting the soft tissue of the person's mouth to thereby spread the pressure across a larger area of tissue, rather than concentrating the retention pressure. The U-shaped body 20 is configured to follow the curvature of the person's mouth between the outer face of the dental arch and the lips and cheeks. This feature allows the lips to apply pressure to the device to produce a seal between the device and the mouth. The compressed oval shape of the device further helps to prevent fatigue of the circular muscles of the lips (the orbicularis oris muscles). It is contemplated that the device 10 is formed of a resiliently deformable or pliant material, such as silicone, that allows the device to flex during use, to eliminate the discomfort of a traditional rigid mouthpiece and to help maintain the seal between the device and the mouth. Allowing the device to flex also facilitates insertion and removal of the device in the mouth. In particular, the U-shaped body can be pinched as needed to pass the device into and out of the mouth.

[0041] The tooth engagement portion 12 includes a pair of wings 30 that project inward from the interior surface 22 of the body 20. The wings 30 are arranged so that they can contact the first and second molars of the upper and/or lower jaw. It can thus be appreciated that the U-shaped body 20 is sized so that the wings can be positioned at the proper molars. The wings have a length sufficient to be contacted by the majority of the first and second molars. The wings 30 have a transverse or lateral width terminating in a curved inner edge 31 so that the wings do not project inside the teeth into the oral cavity. The wings 31 can serve the primary function of a tooth guide, rather than the function as a bite-block. In this embodiment, the wings prevent the device 10 from moving too far up or down in the mouth by contacting the upper or lower molars, thereby preventing the device from moving toward the floor or ceiling of the buccal recess and contacting the more sensitive gum line. In this embodiment, the lateral width of the wings 30 need not extend across the width of the molars. In an alternative embodiment, the wings 30 can be sized to be clamped between the teeth of the person.

[0042] The bite-block portion 12 may be optionally eliminated in the device 10, since the primary retention mechanism for the device 10 is the buccal retention portion 14. As best seen in FIGS. 2 and 4 this retention portion 14 includes a bulbous portion or bulbous protrusion 35 defined on the outer face the U-shaped body 20 projecting laterally toward the cheek (buccal region) of the person. The surface area of each bulbous protrusion 35 is large and configured to conform gently with the cheeks while causing a slight protrusion of the cheeks laterally. The large surface area of contact allows a frictional contact with the cheek sufficient to retain the device in place. The bulbous protrusions project laterally outwardly a sufficient amount to take advantage of a physical characteristic of the human mouth. In particular, the intercommissural distancenamely, the distance between the corners of the mouth as shown in FIG. 11actually gets smaller upon the active opening of the mouth (i.e., increasing the intervermillion distance between the lips as shown in FIG. 11). The overall width W of the device 10 measured from the outer extent of the bulbous protrusions 35 can be approximately equal to the intercommissural distance when the mouth is closed. It can thus be appreciated that when the person opens his/her mouth, the intercommissural distance shortens to less than the width W of the device making accidental expulsion of the device virtually impossible. Even if the person attempts to push the device out with his/her tongue, the device will merely push forward (anteriorly) against the lateral diameter of the corners of the mouth. The cheeks and lips will move forward with the device, but then spring back into the original position because the device is wider than the lateral commissural opening.

[0043] The average person can open his/her mouth to a maximum of 35-55 mm (the vertical dimension or the intervermillion distance shown in FIG. 11). The maximum lateral dimension or the intercommissural distance is 38-50 mm when the mouth is closed, depending on the gender, race, age and overall size of the individual. This distance decreases by about 15% to about 32-42 mm when the mouth is wide open, again depending on the individual. In one specific embodiment, the device is provided in at least two sizesone for smaller adults and one for larger adults. The width W (FIG. 2) of the device is about 57.5 mm or 70 mm, for the smaller and larger individuals, respectively. The height H (FIG. 5) is about 38 mm in both sizes. The bulbous protrusions 35 are sized to project laterally from the outer face of the dental arch from 1 mm to about 30 mm with 15 mm being particularly desirable.

[0044] Placement and removal of the device 10 from the person's mouth requires manual manipulation of the device, and particularly pinching the U-shaped body 20 so that the bulbous protrusions 35 can pass through the open mouth. In order to remove the device, it is obviously necessary to open the mouth sufficiently wide to allow passage of the device. Since the intercommissural distance of the person's mouth shortens to less than the width W of the device, it is necessary to reduce the width by pinching the arms 20a, 20b and bulbous protrusions 35 toward each other.

[0045] The bulbous protrusions 35 are configured for comfort, frictional engagement and maintaining saliva flow. Accordingly, the portions include treads 36 projecting outward (toward the cheek) from the bulbous surface 37. The treads 36 are spaced apart on the surface 37 in a manner similar to treads on an automobile tire. In the illustrated embodiment, the treads are vertically oriented and longitudinally or fore-aft spaced, relative to the lateral width of the device spanning the protrusions, as best seen in FIGS. 2-3. This tread configuration increases the resistance to dislodgement of the device 10 from the mouth of the person as the soft tissue of the cheek engage the valleys 38 between the treads. The treads 36 can also include a longitudinal or fore-aft channel 39 extending along the length of the bulbous protrusion 35. Like automobile tires, the present disclosure contemplates other tread configurations that are capable of helping to retain the position of the device 10 in the person's mouth, as well as other friction-enhancing surface features, such as ridges or protuberances. It is contemplated that the edges of the treads are formed at a radius to minimize tissue irritation. For that matter, all corners and edges of the device 10 are formed at a radius to minimize irritation and discomfort when the device is held in the mouth for extended periods. The radiused features also help prevent retention of food or dead cells within the mouth.

[0046] A typical person generates about 1000 ml of saliva a day, which is essential to maintaining good oral health. Consequently, the treads 36, valleys 38 and channel 39 provide passageways for saliva to flow around the bulbous protrusions 35. In addition, openings 40 are provided in the bulbous surface 35, as best seen in FIGS. 5, 6. The openings 40 are aligned with an elongated opening 45 in the inner surface 21 of the U-shaped body 20 to provide a flow path for saliva into the oral cavity. The elongated opening 45 is located immediately above the bite-blocks 31 for direct flow into the oral cavity, particularly when the upper and lower molars are parted.

[0047] The duct portion 16 provides a passageway for air flow when the device 10 is retained in a person's mouth. The duct begins at an opening 50 defined in the inner surface 21 of the U-shaped body 20. The device 10 is configured so that the opening 50 is centrally oriented in the oral cavity when the device is properly positioned within the mouth. The duct portion 16 can be divided into two channels 52 separated by a septum 53 that extends along the majority of the length of the duct portion as shown in FIG. 6. The duct portion ends in an opening 55 that allows air to flow in and out of the device 10. The opening 55 can include an internal circumferential channel 56 that can be engaged by a separate device to be mounted to the mouthpiece device 10. The duct portion 16 includes an interface section 16a that integrates with the U-shaped body 20, a curved section 16b that curves downward from the mouth, and an outlet section 16c that is in the form of an elongated cylindrical section adapted to mate with auxiliary devices. The septum 53 separates the two channels from the interface section 16a and along the length of the curved section 16b. The curved section 16b orients the opening 55 away from the face of the person and is configured to provide clearance from the chin of the person. In the illustrated embodiment the opening 55, and thus the outlet section 16c, is elongated or oval in shape to accommodate the two channels 52. However, the opening and outlet section can be circular to correspond to standard medical tubing, or can have any other cross-sectional shape depending on the particular device to be integrated with the mouthpiece device 10. The curved section 16b can be modified appropriately to transition from the cross-sectional configuration of the oval opening 52 at the body 20 to the cross-sectional configuration of the outlet section 16c. In that respect, the duct portion 16 can be provided as a separate component from the body 20 and the bite-block and buccal retention portions. In this instance, the opening 52 defined in the body 20 can incorporate a snap-fit of interference-fit feature to engage a similarly configured separate duct portion component. This approach allows a single one-piece component that is disposed within the mouth of the person to attach to several different separate duct portion components.

[0048] The mouthpiece device 10 is particularly suited for supporting an auxiliary re-breather device, such as the rebreathing device 60 shown in FIGS. 8-10. The rebreathing device includes a body 61 that is contoured to curve around the jaw of the person to minimize the prominence of the device. The body 61 defines an interior chamber 64 with outlet openings 65, 66 at the opposite lateral sides of the device. The body further defines a mating interface 68 that is configured to engage the outlet section 16c of the mouthpiece device 10. The mating interface can be a collar in the body 61 adapted for a press-fit engagement with the outer surface of the outlet section 16c, or can be an elongate cylindrical component with circumferential ridges 69 adapted to fit through the opening 55 and to engage the internal circumferential channels 56 to removably hold the rebreathing device 60 on the mouthpiece 10. The rebreathing device 60 is configured to achieve the rebreathing and CO.sub.2 enhancement features of the rebreathing devices disclosed in the '149 application and described above. The rebreathing device 60 can have any of the configurations shown in FIGS. 13-21B that allow calibration of the dead space volume as described above.

[0049] The mouthpiece device 10 can also be used with devices other than the rebreathing devices described above. For instance, the outlet section 16c can be coupled to a gas delivery tube. The buccal retention portion of the device holds it in the person's mouth, even if the person is unconscious. The overall configuration of the U-shaped body of the device maintains an air-tight seal during inhalation and exhalation so there is minimal leaking of gas being delivered to the person. The mouthpiece device can also be coupled to tubing of a CPAP machine, eliminating the need to wear a face mask.

[0050] The mouthpiece device 10 is preferably integrally formed as one piece, such as in a conventional molding process. The device is formed of a resiliently pliant material that is soft enough to avoid irritation to the soft tissues of the mouth yet rigid enough to maintain its shape when in continuous use. In one embodiment, the device 10 is formed of a thermoformable material, such as the material used in mouth guards, so that the person can heat the device to its moldable temperature and then press the device against the dental arch as it cools. Thus, in certain embodiments the device can be formed of poly(vinyl acetate-ethylene) copolymer or polyurethane.

[0051] The mouthpiece device 10 of the present disclosure can be easily retained in a person's mouth without the need to clench the teeth, which can lead to jaw fatigue, temporal-mandibular joint (TMJ) dysfunction/pain and other orthodontic problems. The buccal retention portion 14 holds the device in the person's mouth under all circumstances without the need to bite down onto the device. Moreover, the device provides multiple flow paths for saliva originating at the parotid glands in the cheek.

[0052] The present disclosure should be considered as illustrative and not restrictive in character. It is understood that only certain embodiments have been presented and that all changes, modifications and further applications that come within the spirit of the disclosure are desired to be protected.