Tongue retention system

A tongue retaining system is disclosed herein generally having, in one variation, a two-part system. A covering can be sized to fit at least partially over or upon a tongue of a patient, where the covering has an engagement mechanism positioned thereon. A retaining device, sized to fit within a mouth of the patient, may be positioned upon the teeth and have a corresponding engagement mechanism positioned thereon for temporarily coupling with the engagement mechanism on the covering. Such a system can be used to maintain or hold a natural position of the tongue within the mouth of the patient to maintain patency of the airway passages.

FIELD OF THE INVENTION

The present invention relates to a system for maintaining a position of a tongue within a mouth of a patient. More particularly, the present invention relates to methods and apparatus for maintaining a natural position of a patient's tongue to prevent the tongue from obstructing an airway, e.g., for the treatment of sleep apnea.

BACKGROUND OF THE INVENTION

The elimination of snoring and the various degrees of hypopnea and apnea have been attempted because of their various effects on the body. Such conditions typically occur due to pathological disturbances during sleep. One of the reasons of sleep disturbance is due to the tongue relaxing to varying degrees. When fully awake, the tongue has a normal tone and position within the mouth as air passes in and out of the lungs during respiration. As shown inFIG. 1A, a partial cross-sectional view of a patient's P oral cavity is illustrated showing a natural position of the patient's tongue T and the positioning of the soft palate SP. Patency of the airway passage AP between the posterior wall of the pharynx and the base of the tongue B is illustrated to show the normal unobstructed airway when the tongue T is retained in its natural position.

However, during sleep, as the tongue becomes lax it may collapse against the posterior wall of the pharynx not only causing snoring, but also obstructing the passage of air to the lungs. As shown inFIG. 1B, the tongue T is shown in its relaxed and collapsed state illustrating the base of the tongue B pushing against the soft palate SP and also obstructing the airway passage AP.

Conditions such as sleep apnea not only causes drops in the blood oxygenation level, but and may also adversely affect the heart by increasing blood pressure and pulse rate. Many aspects of a person's quality of life, such as a person's physical and emotional health, are affected by obstructive sleep apnea.

A number of conventional treatments exist. For example, conventional treatments such as mask and nasal continuous positive airway pressure (CPAP) devices are typically utilized but compliance is poor and may cause discomfort in the user. Other treatments such as tongue retaining devices are typically made of soft plastic and utilize a tongue-shaped cavity to hold and maintain the tongue in a forward position. Such devices physically clamp onto the tongue using a mechanical grip or retain a portion of the tongue by utilizing a suction device. However, these methods may generally fail due to discomfort by having the tongue compressed or the suction may fail, thereby releasing the tongue to collapse against the pharyngeal wall.

Accordingly, there is a need for a system which maintains the patency of a person's airways during sleep and which is comfortable enough and easy to use to facilitate compliance by the user.

BRIEF SUMMARY OF THE INVENTION

A tongue retaining assembly may generally comprise, in one variation, a two-part system with a covering sized to fit at least partially over or upon a tongue of a patient, the covering having a first engagement mechanism positioned thereon, and a retaining device sized to fit within a mouth of the patient, the retaining device having a second engagement mechanism thereon for coupling with the first engagement mechanism such that a position of the tongue is maintained within the mouth of the patient.

The tongue retaining covering may be disposed over at least a portion of the tongue and may be positioned to closely fit at least partially over or upon or around the tongue and over or upon or around at least an anterior portion of the tongue. The covering may be varied or altered by the user to cover a greater or lesser portion of the tongue depending upon the desired fit and comfort so long as the covered portion of the tongue is sufficient for the covering to hold onto or against tongue.

Moreover, the covering may be comprised of various materials and structures to attain the desired grip or adherence to the tongue surface. One variation may include a mesh covering placed at least partially over, upon, or around the tongue or tongue anterior. Such a covering may be made from any number of biocompatible materials, including but not limited to, methylmethacrylate, mersilene, silicone, polytetrafluoroethylene, polyester, polyethylene, polypropylene, etc. which may be weaved into a braided, woven, or mesh structure having a variable or uniform pitch. Additionally, this type of structure may allow for the individual fibers to move and/or rotate relative to one another such that when a distal portion of the covering is engaged with the retaining device, the tension imparted upon the covering in the axial direction may urge the braided or woven structure to restrict and conform more closely against the tongue surface. The covering may alternatively be configured as a uniform covering made, for example, from a rubber or distensible elastomeric material such as polyurethane.

The retaining device may be configured, for instance, as a mouthguard to fit upon the user's teeth. The retaining member may further have a platform or surface having a magnet or metallic portion thereupon which extends at least partially within the user's mouth to magnetically couple to a corresponding magnet or metallic portion positioned on the retaining member to hold a position of the tongue against the teeth. The retaining member may thus provide a stable platform for coupling and maintaining a position of the user's tongue in a natural position such that patency of the airway passage between the pharyngeal wall and the base of the tongue is maintained. In other variations, the retaining assembly device may be positioned upon the upper teeth, lower teeth, or both upper and lower teeth of the user.

Additionally, aside from utilizing a single or two opposing magnets for coupling the covering and retaining device, multiple magnets or mechanically coupling mechanisms may be utilized. For instance, multiple magnets or coupling mechanisms may be positioned uniformly along a proximal surface of the retaining assembly. The covering may accordingly have multiple complementary magnets positioned therealong over the surface of the covering in corresponding positions such that when each corresponding magnet or coupling mechanism is engaged, a secure attachment which is properly aligned may be ensured.

Aside from magnetic coupling, various other mechanical coupling mechanisms may be utilized to provide for a temporary connection between the two. For example, various mechanical connectors, e.g., locking projections, hook-and-loop connectors, etc., may be utilized for creating mechanical coupling mechanisms.

DETAILED DESCRIPTION OF THE INVENTION

An example of one variation of the tongue retaining assembly may be seen in the side view ofFIG. 2, which shows the oral cavity of a patient P and the soft palate SP. As illustrated, the tongue retaining assembly10may generally comprise, in one variation, a two-part system with a tongue retaining covering12disposed over at least a portion of the tongue T and a retaining assembly18for temporarily coupling with the tongue retaining covering12. The covering12may be positioned to closely fit at least partially over or upon or around the tongue and over or upon or around at least an anterior portion of the tongue TA. Covering12may be varied or altered by the user to cover a greater or lesser portion of the tongue T depending upon the desired fit and comfort so long as the covered portion of the tongue T is sufficient for covering12to hold onto or against tongue T.

The user may position their tongue through opening14and into covering12and advanced such that the tongue T fits snuggly within the covering12and, in this variation, such that a first magnet16located on or near the end of covering12is positioned to lie upon or near the tip of tongue T. With the tongue retaining covering12desirably positioned upon the tongue T, the retaining assembly18may be positioned upon the teeth of the user. In this case, the retaining assembly18may be positioned upon the user's upper teeth.

Retaining assembly18may be generally comprised of a retaining member20configured, for instance, as a mouthguard to fit upon the user's teeth. The retaining member20may further have a platform22or surface having a second magnet24or metallic portion thereupon which extends at least partially within the user's mouth. Once the retaining covering12and retaining member20have been placed within the user's mouth, the first magnet16on covering12may magnetically couple to the second magnet24or metallic portion on retaining member20to hold a position of the tongue T against the teeth. The retaining member20may thus provide a stable platform for coupling and maintaining a position of the user's tongue T in a natural position such that patency of the airway passage AP between the pharyngeal wall and the base of the tongue B is maintained.

Alternatively, the user may position the retaining assembly18upon the user's teeth prior to placement of covering12upon the tongue T. In yet another alternative, the user may simultaneously position the retaining assembly18as well as covering12within the user's mouth. In either case, having a two-piece retaining assembly allows the user greater flexibility in desirably positioning the individual covering12and retaining member20to optimize comfort and efficiency.

In another variation, rather than having retaining assembly18positioned upon the upper teeth UT of the user, a retaining member30may be configured for placement upon the user's lower teeth LT, as shown inFIG. 3. In this case, retaining member30may likewise have a second magnet34or metallic portion positioned upon a proximal surface of the retaining member30. Covering12may also be configured to have a first magnet32positioned upon a lower surface of covering12to correspondingly couple to retaining member30or covering12fromFIG. 2may be simply worn upon the tongue T in a rotated manner such that it couples with the retaining member30positioned upon the lower teeth LT.

A perspective view of the tongue retainer assembly10is shown inFIG. 4. As seen, retainer assembly18may be configured as a mouthguard to fit either upon the upper teeth UT or lower teeth LT of the user. In the variation shown, retaining member20may have a platform22which extends at least partially into the mouth while having a magnet24or metallic portion positioned thereupon. The tongue retaining covering12is shown with the opening14through which the user may position their tongue.

FIG. 5Ashows a close-up of a partial cross-sectional view of one variation of retaining member20illustrating the retaining channel36within which the user may position their upper teeth UT to securely hold the member20. Also shown is the platform22which may extend at least partially along the hard palate within the user's mouth and the position of the at least one magnet24or metallic portion positioned upon the platform22.FIG. 5Balso illustrates a close-up of a partial cross-sectional view of another variation of retaining member20having the at least one magnet24or metallic portion positioned directly upon a proximal or posterior retaining surface38.FIG. 5Cshows yet another variation of a combination retaining assembly40configured as a mouthguard for receiving both the upper teeth UT within retaining channel36and lower teeth LT within retaining channel42in a single device. Moreover, one or more magnets24,24′ may be positioned about the proximal surface of retaining assembly40to provide for additional flexibility in coupling the covering12to the retaining assembly40.

Aside from the retaining member configuration, covering12may be comprised of various materials and structures to attain the desired grip or adherence to the tongue surface. One variation, as shown above, may include a mesh covering12placed at least partially over, upon, or around the tongue T or tongue anterior TA, as shown inFIG. 6A. Such a covering12may be made from any number of biocompatible materials, including but not limited to, methylmethacrylate, mersilene, silicone, polytetrafluoroethylene, polyester, polyethylene, polypropylene, etc. Fibers, strands, or ribbons of such a material may be weaved into a braided, woven, or mesh structure having a variable or uniform pitch which allows covering12to conform closely to the anatomy of the tongue.

Moreover, such a braided, woven, or mesh structure may allow for the individual fibers to move and/or rotate relative to one another such that when a distal portion of covering12is engaged with the retaining device, the tension imparted upon the covering12in the axial direction may urge the braided or woven structure to restrict and conform more closely against the tongue surface. Thus, as the tongue relaxes and further collapses towards the pharyngeal tissue, the greater the retaining force imparted by covering12upon the tongue surface to hold and maintain its position within the patient's mouth. Additionally, covering12may be configured and/or adjusted by the user to cover a sufficient portion of the tongue surface so as to distribute the retaining force imparted by covering12evenly over the tongue to optimize comfort during use.

Aside from a woven or mesh structure, the covering may alternatively be configured as a uniform covering50made, for example, from a rubber or distensible elastomeric material such as polyurethane, as shown inFIG. 6B. In this variation, covering50may be simply slipped over a portion of the tongue T and allowed to conform to the tongue anatomy. After use, it may be simply slipped off and removed.

Aside from utilizing a single or two opposing magnets for coupling the covering and retaining device, multiple magnets or mechanically coupling mechanisms may be utilized. For instance,FIG. 7shows an assembly top view of retaining assembly52formed as a mouthguard which may be positioned along either the upper or lower row of teeth, or both rows. In this variation, the teeth may be positioned within retaining channel54and multiple magnets or coupling mechanisms, in this instance three magnets56,58,60, may be positioned uniformly along a proximal surface of retaining assembly52. Covering12may accordingly have multiple complementary magnets62,64,66positioned therealong over the surface of covering12in positions corresponding to magnets56,58,60such that when each corresponding magnet or coupling mechanism is engaged, a secure attachment which is properly aligned may be ensured.

As mentioned above, aside from magnetic coupling between the retaining device and covering, various other mechanical coupling mechanisms may be utilized to provide for a temporary connection between the two. For example, another variation is shown in the side and bottom views ofFIGS. 8A and 8B, which show retaining member20having a mechanical connector70with a curved receiving channel72defined therealong. Covering12may have a locking projection member74positioned thereon which may be slidably received within receiving channel72to create a temporary mechanical engagement. To disengage, projection member74may be simply slid distally by the tongue to remove projection member74from receiving channel72.

In yet another variation, retaining member20and covering12may be temporarily coupled together via a hook-and-loop connector, such as VELCRO® (Velcro Industries B.V. LLC, Netherlands). Retaining member20may have a hook-and-loop connector76mounted thereon having a plurality of hook fasteners78while the covering12may have a plurality of loop fasteners80disposed thereon for connection with connector76. These variations on connector mechanisms is intended to be illustrative of the various mechanical coupling mechanisms which may be utilized and are not intended to be limiting in any way.

While illustrative examples are described above, it will be apparent to one skilled in the art that various changes and modifications may be made therein. Moreover, various apparatus or procedures described above are also intended to be utilized in combination with one another, as practicable. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.