FIELD OF THE INVENTIONThe present invention relates generally to an anti-snoring device for insertion into a user's mouth for providing an unobstructed buccopharyngeal pathway for inspiratory and expiratory airflow to prevent snoring, sleep disordered breathing and/or obstructive sleep apnea.[0001]
BACKGROUNDSleep Apnea is a common disorder affecting approximately 20,000,000 Americans. Sleep Apnea refers to a cessation of breathing during sleep that lasts at least 10 seconds. Snoring is another common sleep disorder. By conservative estimates, approximately 80,000,000 Americans are afflicted with snoring.[0002]
These sleep disorders cause countless hours of lost sleep and productivity for the afflicted persons, as well as their sleeping partners. In addition, Sleep Apnea is highly associated (50%) with essential hypertension, obesity and heart disease. Moreover, extreme cases of Sleep Apnea can be life threatening.[0003]
Current therapy includes sleep position modification, weight loss, and/or lifestyle changes such as the elimination of alcohol, drug use and/or over-eating. Other therapies include the use of mechanical devices such as oral or nasal devices that augment the airway, surgical procedures to enlarge and stabilize the airway during sleep, and continuous positive airway pressure devices.[0004]
Nasal devices that dilate the anterior nares by external traction or internal splinting have been used with minimal success. Nasal intubation is poorly tolerated and traumatic to the user.[0005]
Current oral devices are typically of two types. One type of oral device involves a tongue retention device that advances and secures the tongue using suction, or mechanical tongue depression and stabilization. However, this type of oral device has limited success and is poorly tolerated by the user. A second type of oral device is a mandibular repositioning device that advances the lower jaw relative to the fixed upper jaw to expand the cross-sectional area of the pharynx thereby improving airflow and preventing collapse. These devices have been variably effective, but commonly have both comfort and compliance problems.[0006]
Surgical treatments are varied and include reconstruction of the palate and uvula, various methods to shrink and stiffen the soft tissue of the upper airway, tonsillectomy, laser treatment, radio frequency tissue reduction, hyoid suspension, and tongue base excision and retention. More radical surgical treatments for severe disorders include tracheotomy and surgical advancement of the upper and lower jaws. Surgical treatments are typically highly expensive, painful, complicated and have varying success rates (typically 40-60%).[0007]
Nasal and/or oral continuous positive airway pressure has been the most successful of the current sleep disorder treatments. However, this treatment is highly expensive and poorly tolerated by many user's who typically find the treatment intrusive and intolerable. Accordingly, a need exists for an effective, well tolerated, economical treatment for persons afflicted with sleep disordered breathing.[0008]
SUMMARYIn one embodiment, the present invention is an anti-snoring device that includes a flexible hollow tube for insertion into a user's mouth, having proximal and distal ends and an outer perimeter. The tube includes an extraoral segment at its proximal end, an intraoral segment at its distal end and an intermediate segment extending therebetween. The extraoral and intraoral segments each include at least one opening. The extraoral segment is for extending beyond the user's outer lips, the intermediate segment is of sufficient length for extending along the buccopharyngeal pathway of the user's mouth, and the intraoral segment is of sufficient length for extending beyond a retromolar space in the user's mouth, into the oropharynx and terminating between the posterior tongue and the soft palate. The anti-snoring device also includes a stop extending from the outer perimeter of the tube on the intraoral segment for securing the intraoral segment within the user's oropharynx.[0009]
Another embodiment of the present invention includes a method of reducing snoring in a user's mouth. The method includes inserting into the user's mouth a flexible hollow tube that has an extraoral segment at its proximal end, an intraoral segment at its distal end and an intermediate segment extending therebetween, wherein the extraoral and intraoral segments each include at least one opening. The method further includes positioning the extraoral segment of the tube exterior to the user's lips, positioning the intermediate segment of the tube along the buccopharyngeal pathway of the user's mouth and positioning the intraoral segment of the tube beyond a retromolar space in the user's mouth, into the oropharynx and terminating between the posterior tongue and the soft palate.[0010]
BRIEF DESCRIPTION OF THE DRAWINGSThese and other features and advantages of the present invention will be better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein:[0011]
FIG. 1A is a front perspective view of one embodiment of an anti-snoring device according to the present invention;[0012]
FIG. 1B is a front perspective view of another embodiment of an anti-snoring device according to the present invention;[0013]
FIG. 1C is a front perspective view of another embodiment of an anti-snoring device according to the present invention;[0014]
FIG. 1D is a cross-sectional side view of the anti-snoring device of FIG. 1C;[0015]
FIG. 2A is a front perspective view of another embodiment of an anti-snoring device according to the present invention;[0016]
FIG. 2B is a front perspective view of another embodiment of an anti-snoring device according to the present invention;[0017]
FIG. 2C is a cross-sectional side view of the anti-snoring device of FIG. 2B;[0018]
FIG. 3 is a cross-sectional view of the upper side of a user's mouth having an anti-snoring device according to the present invention inserted therein.[0019]
FIG. 4 is a front perspective view of another embodiment of an anti-snoring device according to the present invention;[0020]
FIG. 5A is a front perspective view of another embodiment of an anti-snoring device according to the present invention; and[0021]
FIG. 5B is a cross-sectional side view of the anti-snoring device of FIG. 5A.[0022]
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTIONAs shown in FIGS. 1A-5, an embodiment of the present invention is an anti-snoring device for insertion into a user's mouth for providing an unobstructed buccopharyngeal pathway for inspiratory and expiratory airflow to prevent snoring, sleep disordered breathing and/or obstructive sleep apnea. Snoring is a common benign condition characterized by noisy harsh breathing during sleep resulting from soft tissue airway collapse and vibration during the respiratory cycle. This creates a dynamic vibratory resonance between the pressure of respiratory effort and the inherent elastic recoil of the soft tissues.[0023]
In the embodiments of FIGS. 1A-5, the[0024]anti-snoring device10 includes a flexiblehollow tube8 having three segments, anextraoral segment14, anintermediate segment16, and anintraoral segment18. The extraoral14 and intraoral18 segments each include at least one opening. For example, in the depicted embodiment, theextraoral segment14 includes anopen end20 and theintraoral segment18 includes anopen end21.
As shown in FIG. 3, when the[0025]anti-snoring device10 is inserted into a user's mouth25 abuccopharyngeal pathway11 is created for inspiratory and expiratory airflow as illustrated byarrows22. Thebuccopharyngeal pathway11, as used herein, is defined as a pathway extending along anouter surface28 of the of the user's dentition, between theouter surface28 of the user's dentition and aninner surface26 of the user's inner cheek, wherein dentition is defined as the user's teeth and gums in the user's dental arch.
When the[0026]anti-snoring device10 is positioned as shown, theintraoral segment18 extends past a retromolar space27 (defined as an area in the user's upper or lower dentition past the user's last molar or an area past the user's upper and lower dentitions when the user's mouth is closed), enters the oropharynx30 (defined as the posterior oral cavity behind the user's dentition) and terminates between the posterior tongue and the soft palate. Theretromolar space27 as defined herein is created by the removal or nonexistence of at least the upper and/or lower third molar in the user'smouth25.
In the depicted embodiment, the user's mouth contains a first[0027]upper molar31 and a secondupper molar32, but does not contain a third upper molar. The absence of the third upper molar allows theanti-snoring device10 to cross behind the user's dentition and enter the user'soropharynx30. Although, the upper teeth are depicted, a depiction of the lower teeth would be substantially similar and is not included herein to avoid duplicity.
Adjacent to the[0028]intraoral segment18 is theintermediate segment16. Theintermediate segment16 extends along thebuccopharyngeal pathway11. Theintermediate segment16 may be positioned adjacent to the user's upper dentition, lower dentition or both the upper and lower dentitions, and may pass through theretromolar space27 in the user's upper dentition, lower dentition or both the upper and lower dentitions, as long as theintermediate segment16 passes along thebuccopharyngeal pathway11 and theintraoral segment18 enters theoropharynx30. Theextraoral segment14 is adjacent to theintermediate segment16. Theextraoral segment14 extends past the user'slips34 and outside the user'smouth25.
When the[0029]anti-snoring device10 is positioned as described above, the uniquebuccopharyngeal pathway11 is created as depicted byarrows22 for inspiratory and expiratory airflow during sleep. Thebuccopharyngeal pathway11 is unique because it utilizes a route of airflow that is typically not used in normal breathing patterns and is not previously described in the medical literature as a route for respiratory airflow. Thebuccopharyngeal pathway11 presents a pathway for airflow during normal breathing patterns only when it is “stented” open by theanti-snoring device10 as described above. Theanti-snoring device10 also allows for thebuccopharyngeal pathway11 to be stented open even with the user's mouth closed and allows the user's dentition to remain in its natural and normal position, while accommodating normal jaw movement. As a result, normal swallowing, throat clearing, yawning, coughing and sneezing are not disturbed when theanti-snoring device10 is in the user's mouth. In addition, since theintraoral segment18 is positioned in theposterior oropharynx30 and terminates on the lateral-posterior tongue the naturally triggered gag reflex is markedly diminished.
The[0030]anti-snoring device10 eliminates snoring, sleep disordered breathing and obstructive sleep apnea for several reasons. For example, theintraoral segment18 “stents” open or separates the posterior tongue and the soft tissue of the soft palate, which tend to collapse and vibrate during sleep to create the sound of snoring. Theanti-snoring device10 also allows free flow of air to the posterior oral cavity at a markedly reduced resistance which allows for a decreased vacuum (negative) pressure of inspiration and a reduced pulsion (positive) pressure of expiration.
The[0031]anti-snoring device10 also contains a flexible outwardly extendingstop13 that forms a portion of theintraoral segment18. In one embodiment, thestop13 extends annularly about thetube8. In another embodiment, thestop13 extends from the outside diameter of thetube8, but does not extend annularly about thetube8. Thestop13 serves to secure theanti-snoring device10 against anterior displacement, and secures theintraoral segment18 within theoropharynx30 of the user'smouth25. Thestop13 is larger than theretromolar space27 and therefore prevents retraction therethrough. Thestop13 frictionally secures theintraoral segment18 within theoropharynx30 by abutting the last tooth in theretromolar space27, which in the depicted embodiment is thesecond molar32, and/or the portions of the jaw bone and/or gums that surround theretromolar space27.
The[0032]stop13 may be adjustable along the length of thetube8, for example, by being slidably mounted on theoutside diameter42 of thetube8. For example, in the embodiments shown in FIGS. 1-3, thestop13 is a sleeve, that has aninner opening52 that is slightly smaller than or approximately equal to theoutside diameter42 of thetube8. As a result, thestop13 is frictionally secured to thetube8, but can be adjusted by the user along theoutside diameter42 of thetube8 by the application of an appropriate force. The adjustability of thestop13 allows theanti-snoring device10 to conform to the user's particular anatomy and allows the user to vary the length of thetube8 that enters theoropharynx30.
The[0033]stop13 may have any shape and size as long as it comfortably fits within theoropharynx30 of the user's mouth and secures theintraoral segment18 within theoropharynx30 of the user'smouth25. For example, in the embodiments shown in FIGS. 1-3, thestop13 is a sleeve having concentric circular outside and inside surfaces, wherein the outside diameter d is approximately 28 French (Fr) to approximately 38 Fr, the inside diameter id is approximately 26 Fr to approximately 36 Fr, the length l is approximately {fraction (3/16)} inch to approximately {fraction (1/2)} inch and the thickness t is approximately 0.3 Fr to approximately 2.5 Fr, wherein 1 French is a unit of measure equal to 3.01 millimeters.
In one embodiment, the[0034]stop13 has an outer diameter d of approximately 30 Fr, an inside diameter id of approximately 28 Fr, a length l of approximately {fraction (1/4)} inch, a thickness t of approximately 1.0 Fr and thetube8 has anoutside diameter42 of approximately 28 Fr.
In the embodiments of FIGS. 1C-1D and[0035]2B-3, theanti-snoring device10 also contains a thinflexible retention diaphragm12 that forms a portion of theintermediate segment16. Theretention diaphragm12 contains afirst side38 that, due to its flexibility, conforms to the user's inner lips and/or inner cheek and asecond side40 that conforms to an outer surface of the user's teeth. Theretention diaphragm12 secures theintermediate segment16 within the user'sbuccopharyngeal pathway11 and prevents anterior displacement of theanti-snoring device10. Theretention diaphragm12 also acts as a saliva dam to prevent drooling of naturally occurring saliva developed during sleep.
The[0036]retention diaphragm12 is adjustable, for example, by being slidably mounted to theoutside diameter42 of thetube8. For example in one embodiment, theretention diaphragm12 includes anopening50 that is slightly smaller than or equal to theoutside diameter42 of thetube8. As a result, theretention diaphragm12 is frictionally secured to thetube8, but can be adjusted by the user along theoutside diameter42 of thetube8 by the application of an appropriate force. The adjustability of theretention diaphragm12 allows theanti-snoring device10 to conform to the user's particular anatomy.
The[0037]retention diaphragm12 may have any shape and size, as long as it fits comfortably within the user's mouth between the user's inner lips and/or inner cheek and an outer surface of the user's teeth. For example, theretention diaphragm12 may be circular, rectangular, square, oval-shaped or any other suitable shape. In the embodiment shown herein, theretention diaphragm12 has a square outer perimeter or shape, having sides that are approximately {fraction (3/4)} inch to approximately 1½ inch. The square shape helps to prevent rotation of thedevice10 when it is in use as described above. In the depicted embodiment, theretention diaphragm12 has an outer perimeter that is square having 1 inch sides, wherein theopening50 is circular with a diameter of approximately 28 Fr and thetube8 has anoutside diameter42 of approximately 28 Fr. In the embodiments depicted, theretention diaphragm12 has a thickness T of approximately 0.030 inches to approximately 0.060 inches.
In the embodiment of FIGS. 2A-2C, each of the segments of the tube[0038]8 (theextraoral segment14, theintermediate segment16, and the intraoral segment18) additionally contains side openings orside ventilation openings24A-24G. Theventilation openings24A-24G serve to maximize airflow that may be restricted, for example by pillows, bed sheets or other objects obstructing theopen end20 of theextraoral segment14 and/or soft tissue or other objects obstructing theopen end21 of theintraoral segment18.
For added ergonomic effect and comfort, and for proper fitting in the user's mouth, the[0039]anti-snoring device10 depicted in FIG. 1A-2C has a preformed bend such that aconvex side44 of thetube8 and an oppositeconcave side45 of thetube8 are curved to closely follow the shape of a typical user's dentition. For example, in one embodiment the bend approximates an arc of a circle having a radius in the range of approximately 2.5 inches to approximately 5.0 inches, such as 4.0 inches.
In the depicted embodiment the[0040]ventilation openings24A-24G are circular in shape with a diameter of approximately 5 mm. In this embodiment, theextraoral segment14 contains oneventilation opening24A disposed on theconvex side44 of thetube8, theintermediate segment16 contains twoventilation openings24B and24C disposed on an upper46 side, between the convex44 and concave45 sides, of thetube8, and twoventilation openings24D and24E disposed on an opposite lower48 side of thetube8, and theintraoral segment18 contains twoventilation openings24F and24G disposed on theconvex side44 of thetube8 and oneventilation opening24H disposed on theconcave side45 of thetube8.
However, the[0041]ventilation openings24A-24G may have any size and shape and eachsegment14,16 and18 may contain any number ofventilation openings24A-24G as long as theventilation openings24A-24G allow airflow to enter into thetube8 and allow sufficient airflow through thetube8 when theopenings20 and21 at the extraoral14 and the intraoral18 segments are obstructed. Theventilation openings24A-24G may also be disposed on thetube8 at positions other than that shown in FIGS. 2A-2C. However, the positions shown minimizes the likelihood that theventilation openings24A-24G will be obstructed.
For example, positioning ventilation openings in the[0042]convex side44 of theextraoral segment14 minimizes the likelihood that the user's outer lips will obstruct the ventilation openings in theextraoral segment14 since the user's lips are adjacent to theconcave side45 of thetube8 when theanti-snoring device10 is in use; positioning ventilation openings between the convex44 and concave45 sides in the upper46 and/or lower48 sides of theintermediate segment16 minimizes the likelihood that theinner surface26 of the user's inner cheek and/or theouter surface28 of the of the user's dentition will obstruct the ventilation openings in theintermediate segment16; and positioning ventilation openings in the concave45 and the convex44 sides of theintraoral segment18 minimizes the likelihood that the user's tongue or soft palate will obstruct the ventilation openings in theintraoral segment18.
The preformed bend of the[0043]anti-snoring device10, having the convex44 and the concave45 sides that are curved to closely follow the shape of a typical user's dentition, facilitates the user in properly inserting theanti-snoring device10 into the user's mouth and ensures that when theanti-snoring device10 is inserted properly, theventilation openings24A-24G are properly aligned within the user's mouth. However, as shown in FIG. 3, when the user positions theintraoral segment18 beyond theretromolar space27 in the user's mouth, into the oropharynx and terminating between the posterior tongue and the soft palate, theintraoral segment18 may bend inwardly more sharply than the preformed bend for proper placement in the user's mouth. In one embodiment, the above described preformed bend contains an additionalinward bend60 near the junction of the intermediate16 and intraoral18 segments as shown in FIG. 3. Theinward bend60 is bent at an angle α in the range of approximately 65 degrees to 135 degrees, such as 100 degrees.
In the embodiment of FIG. 1A, the[0044]open end21 of theintraoral segment18 is cut straight across thetube8, i.e. approximately straight across from theupper side46 of thetube8 to alower side48 of thetube8. In the embodiments of FIGS. 1B-2C, theopen end21A of theintraoral segment18 is angled starting from theupper side46 of thetube8 to alower side48 of thetube8 at an angle. In one embodiment, this angle is approximately 45 degrees, however, in other embodiments larger or smaller angles may be used. The angledopen end21A of theintraoral segment18 facilitates insertion of theintraoral segment18 into theretromolar space27. In addition, the angledopen end21A of theintraoral segment18 makes it less likely that the tongue or soft palate will occlude theopen end21A when theanti-snoring device10 is in use.
In one embodiment, the[0045]tube8 has a predetermined length of approximately 9 cm to approximately 13 cm. Although other lengths may be used, when the tube length is longer than 15 cm theextraoral segment14 extends too far from the typical user's mouth, which may cause theextraoral segment14 to bind or become obstructed, and when the tube length is shorter than 9 cm thetube8 is not long enough for both theextraoral segment14 to extend from the user's mouth and theintraoral segment18 to extend into theoropharynx30 of the user's mouth for a typical user. In one embodiment, thetube8 has a length of 12 cm.
In one embodiment, the[0046]tube8, theretention diaphragm12 and thestop13 are each composed of a flexible, elastic material, such as a non-latex polyvinyl chloride material. When theanti-snoring device10 is composed of a flexible, elastic material, theanti-snoring device10 is allowed to negotiate the contours of the user'sbuccopharyngeal pathway11 while maintaining user comfort. In addition, the flexibility and elasticity of theanti-snoring device10 allows for a compression of theanti-snoring device10 during normal sleeping functions, such as swallowing and teeth clenching, while allowing theanti-snoring device10 to regain its original dimension when those force are relieved.
In the depicted embodiments, the[0047]outside diameter42 of thetube8 is approximately 26 Fr to approximately 36 Fr, the inside diameter43 of the tube is approximately 24 Fr to approximately 34 Fr, and thethickness41 of thetube8 is approximately 0.3 Fr to approximately 2.5 Fr. In one embodiment, theoutside diameter42 of thetube8 is approximately 28 Fr, the inside diameter43 of thetube8 is approximately 26 Fr and thethickness41 of thetube8 is approximately 1.0 Fr.
The[0048]outside diameter42 of thetube8 may be larger than 36 Fr, but at diameters larger than 36 Fr user comfort begins to decrease. The inside diameter43 of thetube8 may be smaller than 26 Fr, but sufficient airflow begins to diminish at 26 Fr. Thethickness41 of thetube8 may be smaller than 0.3 Fr or larger than 2.5 Fr, but at smaller thicknesses thedevice10 becomes too flimsy and a larger thicknesses thedevice10 becomes too stiff.
In one embodiment, all of the outer edges of the[0049]tube8, theretention diaphragm12 and thestop13 are rounded to avoid abrasion or irritation of the user's soft tissue when the device is in use, as described above.
Any of the embodiments described above may include the preformed shape as shown in FIG. 5. In the preformed shape of FIG. 5, the[0050]tube8 includes a firstconcave surface54A and an opposite firstconvex surface56A that each integrally adjoin, respectively, a secondconvex surface54B and an opposite second concave surface56B, such that thetube8 is approximately “S-shaped”. In one embodiment, the firstconcave surface54A and the firstconvex surface56A are disposed on the extraoral14 and intermediate16 segments and the secondconvex surface54B and the second concave surface56B are disposed16 on theintraoral segment18.
In any of the embodiments shown in FIGS. 1-3, the[0051]stop13 may be formed as a preformed expansion in the tube8 (as is shown in FIGS. 4A and 4B), that extends fromoutside diameter42 of thetube8. In one embodiment, the preformed expansion extends annularly about thetube8. In another embodiment, the preformed expansion extends from the outside diameter of thetube8, but does not extend annularly about thetube8.
In one embodiment shown in FIGS. 4A and 4B, the dimensions of the[0052]stop13 when thestop13 is formed as a preformed expansion in the tube8 (the outer diameter d, the inside diameter id, the length l, and the thickness t) are approximately the same as the dimensional ranges given above in the embodiments where thestop13 is a sleeve.
The preceding description has been presented with reference to various embodiments of the invention. Persons skilled in the art and technology to which this invention pertains will appreciate that alterations and changes in the described structures and methods of operation can be practiced without meaningfully departing from the principle, spirit and scope of this invention. Accordingly, the foregoing description should not be read as pertaining only to the precise structures described and shown in the accompanying drawings, but rather should be read as consistent with and as support for the following claims, which are to have their fullest and fairest scope.[0053]