Method and apparatus for reducing snoring

A mandible support device comprising a structural member comprising a support component and an adhesive component. The support component is configured to extend from the head or face above the mandible to the region of the gonial angle. The adhesive component is configured such that the structural member can be temporarily attached to the skin.

CROSS REFERENCE TO RELATED APPLICATIONS

Not applicable.

Not applicable.

REFERENCE TO APPENDIX

Not applicable.

BACKGROUND OF THE INVENTION

Field of the Invention

The inventions disclosed and taught herein relate generally to a device and method for reducing or eliminating snoring; and more specifically relate to a simple, comfortable, and easy to manufacture device for the reduction or elimination of snoring and a method for using the same.

Background Information and Description of the Related Art

The fundamental cause of snoring is a restriction or blocking of the air passage in the throat. Such a restriction in the throat air passage may occur during sleeping, when muscles of the face and throat relax. The relaxed muscles reduce support of the mandible, which allows the mandible to shift in a posterior direction. In turn, the shifted mandible allows soft tissue in the back of the throat to sag. The sagging soft tissue then blocks the flow of air needed for breathing.

A sleeping person will generally respond to the blockage of the airway by breathing harder, thereby increasing the air pressure in the airway. The increased air pressure results in a partial opening of the airway. The snoring sound is the restricted airflow vibrating the soft tissue. The snoring noise disturbs the sleep of others in the proximity of the snoring person, and the snoring person has laborious breathing that reduces the quality of sleep. Extreme cases of air passage blockage often result in a medical condition, called obstructive sleep apnea, where the quality of sleep is severely degraded and other deleterious health effects are exhibited.

There are a number of types of treatments for snoring in the prior art. These various treatments can be divided into at least two classes: surgical and mechanical. Surgical treatments include palatal implants, in which braided strands of polyester filament are injected into the snorer's soft palate, with the intention of stiffening the soft tissues and reducing snoring. Another surgical treatment is uvulopalatopharyngoplasty, which can be conducted using traditional or laser-assisted surgical techniques to shorten the soft palate and remove the snorer's uvula, enlarging the airway with the intent of reducing vibration of the soft tissues during sleep. Another surgical treatment is radiofrequency tissue ablation (somnoplasty), in which low-intensity radiofrequency signals are used to shrink tissue in the soft palate. The surgical treatments for snoring all have the risks associated with surgery, are expensive, and of uncertain effectiveness.

Mechanical treatments for snoring include continuous positive airway pressure (CPAP) devices. The user of a CPAP device wears a mask over the nose and/or mouth while sleeping. The mask is attached to an air pump that forces air through the snorer's airway to raise the air pressure inside the airway to approximately 70 to 120 Pascal above atmospheric pressure. The increased pressure functions to reduce or eliminate the airway blockage caused by the sagging soft tissue. The CPAP is generally considered to be the most reliable treatment for snoring and obstructive sleep apnea. However, the equipment is bulky and many individuals who begin using a CPAP find it uncomfortable or disruptive to sleep. Studies suggest that approximately half of the individuals who begin using a CPAP machine to treat sleep apnea cannot tolerate them and discontinue their use.

Other mechanical treatments for snoring include oral appliances. Oral appliances are form fitting dental mouthpieces that help advance the position of the tongue and soft palate with the intent of opening the airway, often by repositioning the lower mandible to jut forward into an unnatural position. Oral appliances are relatively expensive, and have a variety of sometimes-severe side effects, including jaw pain, facial discomfort, and modified tooth alignment.

Examples of such oral appliances include U.S. Pat. No. 7,832,403 issued to Halstrom on Nov. 16, 2010, in which a mandible position device is described as having a maxillary dentition engagement component and a mandibular dentition engagement component, each on opposite sides of a plane extending therebetween. An adjustable connection couples the maxillary dentition engagement component with the mandibular dentition engagement component. The adjustable connection has a first adjustment screw having a longitudinal axis perpendicular to the plane. The first and second adjustable screws are independently adjustable and structures to effect horizontal and vertical displacement, respectively, of the maxillary dentition engagement component relative to the mandibular dentition engagement component.

Other examples of such oral appliances include U.S. Pat. No. 8,613,283 issued to Hegde on Dec. 24, 2013, in which a mandibular advancement appliance is described which is secured to a subject's dentition. The appliance may adjust a portion of the subject's lower dentition relative to the upper dentition while maintaining a distance between the upper and lower dentition. The appliance may also allow for the free rotation of the lower dentition relative to the upper dentition for increased comfort. Additionally, the appliance may also be utilized with a tongue retention assembly for maintaining a position of the subject's tongue relative to the device for treating sleep disordered breathing.

A third category of mechanical devices for the reduction or prevention of snoring includes devices that are worn externally on or about the face and/or neck of the subject. Some such devices are braces and similar structures that are worn about the head and neck. For example, U.S. Pat. No. 8,695,607 issued to Hohenhorst on Apr. 15, 2014, discloses apparatus, systems, and methods to constrain and/or support tissue structures along an airway. Hohenhorst discloses apparatus, systems, and methods that externally brace tissues structures in, on, or near the neck, along the walls of the pharyngeal airway itself. The apparatus, systems, and methods mechanically support these tissue structures in, on, or near the neck in a desired orientation, biased away from the pharyngeal airway. The mechanical support that the apparatus, systems, and methods provide affirmatively resists collapse of the tissue structures in, on, or near the neck toward and into the pharyngeal airway, thereby moderating or preventing the incidence of sleep apnea. Such apparatus, systems, and methods disclosed by Hohenhorst include, for example, a full collar structure that is worn about the entire neck at the level of the larynx and including releasable fasteners so that an individual can adjust the fit and form of the collar around their neck.

Other such devices are intended to adhere to the face or neck of a subject to mechanically enlarge an airway. For example, U.S. Pat. No. 5,752,524 issued to Corcoran on May 19, 1998, discloses a device for preventing or reducing snoring. The Corcoran device includes in combination a rigid ellipsoidal support base having a concave interior surface and a convex exterior surface and an adhesive material for attaching to human epidermis layered on a predominance of the entire convex interior surface. The device is stated to be “particularly useful to prevent snoring in a sleeping human by providing a small air passage between the superior maxillary facial muscles of the face, and the superior maxilla (upper jaw bone), which allows for the intake and output of air such that the sleeping individual does not have to intake and output air through the nose. By this means, snoring is prevented, or markedly reduced.”

Another example of such a device is disclosed in U.S. Pat. No. 7,793,661 issued to Macken on Sep. 14, 2010. Macken discloses an anti-snoring device that attaches to a specific area of the neck. The attachment means can be an adhesive, a clip or an implant. The device exerts a predetermined pulling force on this area of the neck, causing this area of the neck to expand outward from its normal position. This expansion opens a blockage in the throat of a sleeping person, thereby eliminating snoring and helping some people with obstructive sleep apnea.

Another example of such a device is disclosed in U.S. Pat. No. 8,188,330 issued to Beaudry on May 29, 2012. Beaudry discloses a dressing mechanism comprising a first section, a second section, and a third section. The first section and the third section each may include one side having an adhesive layer. An overlaying, non-adhesive barrier layer may be located between a portion of the adhesive layer and a first or third section. At least one of the first or third sections may further include a plurality of hook or loop members which are arranged to be fastened to corresponding hook or loop members of a hook and loop fastener. Several forms of the mechanism disclosed by Beaudry related to epidermal lifting mechanisms and methods for increasing the flow of gases into the human body and more specifically to an epidermal lifting mechanism and method for allowing more oxygen to pass through the nasal cavity thus increasing both the flow of oxygen into the lungs and the flow of air exhaled from the lungs.

The inventions disclosed and taught herein are directed to a device and method for reducing or preventing snoring that is not present in the prior art. The inventions disclosed and taught herein are simple and comfortable to use, inexpensive to manufacture, and do not require surgical intervention.

BRIEF SUMMARY OF THE INVENTION

In brief summary, one possible embodiment of the disclosed invention the mandible support device comprises a structural member having a first side and a second side and comprising a first section, a second section, and a third section. The first section and the third section of the structural member each comprise a proximal portion and a distal portion; where the proximal portion of the first section is coupled to the second section, the proximal portion of the third section is coupled to the second section, and the second section is shaped and sized to correspond substantially to the shape of gonial angle, also referred to as the angle of the mandible. At least a portion of at least one of the first section, the second section, and the third section may be comprised of a material exhibiting at least some elastic properties. The adhesive component comprises a first adhesive layer and a second adhesive layer, each comprising a first adhesive side and a second side, where the second side of the first adhesive layer is disposed on at least a portion of the first side of the distal portion of the first section and the second side of the second adhesive layer is disposed on a least a portion of the first side of the distal portion of the third section. The structural member is shaped and sized to extend at least from the region above the mandible, for example the zygomatic bone and/or maxilla, to the region on, behind or beneath the gonial angle, and along the course of the mandible towards the chin.

In brief summary of another of many embodiments of the invention, is a mandible support device comprising a structural member. The structural member comprises a support component and an adhesive component, wherein the support component is configured to extend from at least a portion of a zygomatic bone and/or maxilla of a face to at least a portion of the gonial angle and the adhesive component is configured such that the structural member can be temporarily attached to the epidermis. The function of the mandible support device is to provide passive support of the mandible to reduce the posterior movement of the mandible during sleep. One end of the support component is adhered to the epidermis of the head or face above the mandible, for example, about the zygomatic bone and/or maxilla. Another end of the mandible support device is adhered to the epidermis on, beneath, or behind the gonial angle. Tension applied to the support component restricts posterior movement of the mandible that naturally occurs as a result of gravity and muscle relaxation.

The invention also relates to a method for using the mandible support device described herein, where the first side of the distal portion of the first section of the structural member is affixed to the epidermis covering the zygomatic bone and/or maxilla, the second section of the structural member is positioned on, behind, or beneath the gonial angle and the first side of the distal portion of the third section of the structural member is affixed to the epidermis of the region along the course of the mandible toward the chin.

DETAILED DESCRIPTION OF THE INVENTION

Applicants have created a mandible support device designed to be used during sleep for the prevention or reduction of snoring. The mandible support devise comprises a flexible strap, wherein said strap is sized to extend at least from the region above the mandible, for example the zygomatic bone and/or maxilla, the region on, behind or beneath the gonial angle. The structural member also comprises an adhesive material, wherein the adhesive material is applied to the structural member such that the structural member can be temporarily attached to the epidermis covering the face and/or neck of a human.

In one of many possible embodiments of the present invention, the mandible support device comprises a structural member. The structural member in turn comprises a support component and an adhesive component, wherein the support component is configured to extend from at least a portion of the region above the mandible, for example the zygomatic bone and/or maxilla, to at least a portion of the region of the gonial angle, and the adhesive component is configured such that the structural member can be temporarily attached to epidermis. The function of the mandible support device is to provide passive support of the mandible to reduce or restrict the posterior movement of the mandible that naturally occurs during sleep. The support component is adhered to the epidermis at least on or about the region above the mandible, such as the zygomatic bone and/or the maxilla, and the gonial angle. Tension in the support component restricts posterior movement of the mandible that naturally occurs as a result of gravity and muscle relaxation.

FIG. 1shows an alternative embodiment of the present invention. The mandible support device100comprising a structural member110. The structural member110has a first side and a second side, and further comprises a first section120, a second section130, and a third section140. The first section120comprises a first section distal portion150and a first section proximal portion160. The third section140comprises a third section distal portion170and a third section proximal portion180. The first section proximal portion is coupled to the second section130and the third section proximal portion180is coupled to the second section130. The second section130is shaped and sized to correspond substantially to the shape and size of the gonial angle. The shape and size of the second section130may be configured to be somewhat larger or smaller than the gonial angle of a particular user or of average gonial angle size and shape, depending on the specific application and the intended positioning of the first section120relative to the user's zygomatic bone, maxilla, or other region above the mandible. The third section is configured to run from the region of the gonial angle along the mandible toward the chin.

The structural member110has a support component and an adhesive component, with a suitable adhesive as previously discussed herein. The adhesive component of the structural member110results from an adhesive layer disposed to the first side of the structural member110. The adhesive component should include an adhesive layer disposed on at least the regions of the first section distal end150and the third section distal end170. However, an adhesive layer can be applied to the second section130in addition, creating a third adhesive portion in the second section130. In addition, an adhesive layer can be applied to the entire first side of the structural member110, thereby creating an adhesive region over the entirety of the first side of the structural member110. The amount, type, quantity and placement of the adhesive and adhesive regions may be adjusted as appropriate, as would be understood by a person of skill in the art to achieve the function of the mandible support device100.

The mandible support device100can also include a positioning component190. Positioning component190is disposed substantially within the second section130and is configured to substantially match the shape and size of the gonial angle. Positioning component190can be disposed on the first side or the second side of the support component of the structural member110. As discussed above, the positioning component190serves two primary functions: first, to assist in the correct placement of the mandible support device100, and second, to provide additional support of the mandible, thereby preventing posterior movement of the mandible.

A positioning component190can be used to aid in the positioning of the second section130of the structural member110to the region on, behind, or beneath the gonial angle. The positioning component190should be disposed on the structural member110in such a manner that the location of the contours of the positioning component190can be felt relative to the gonial angle when the structural member110is applied on the user. The positioning component190should be sufficiently flexible to be comfortable on the user's epidermis and to be able to conform to the shape and size of the region on, beneath, or behind the gonial angle. The positioning component190should also be sufficiently rigid to provide some tactile resistance, thus providing tactile feedback to the user regarding placement of the second section130of the structural member110relative to the gonial angle.

The positioning component190has an additional function of providing support to the mandible and reducing a shift of the mandible in a posterior direction. Specifically, and as discussed previously, the positioning component190when adhered to the epidermis covering the face and neck on, beneath, or behind the gonial angle provides a ledge-like structure against which the gonial angle can rest upon relaxation of the facial and neck muscles, thereby aiding in the prevention of a posterior shift of the mandible.

The mechanism of operation of the mandible support device100is dependent on passive external support of the mandible. This passive support is provided at the gonial angle. During sleeping, the muscles of the face and throat relax. During a waking state, these muscles provide support for the mandible; relaxation of the muscles during sleep results in a reduction of support of the mandible. The reduced muscular support allows the mandible to shift in a posterior direction with the force of gravity. In turn, the shifted mandible allows soft tissue in the back of the throat to sag. The sagging soft tissue blocks the flow of air needed for breathing.

Such a restriction in the throat air passage may occur during sleeping, when muscles of the face and throat relax. The relaxed muscles reduce support of the mandible, which allows the mandible to shift in a posterior direction. In turn, the shifted mandible allows soft tissue in the back of the throat to sag. The sagging soft tissue then blocks the flow of air needed for breathing. A sleeping person will generally respond to the blockage of the airway by breathing harder, thereby increasing the air pressure in the airway. The increased air pressure results in a partial opening of the airway. The snoring sound is the restricted airflow vibrating the soft tissue.

The amount of support provided by various mandible support devices100can also be affected by the material comprising the support component of the structural member110. The support component of the structural member110can comprise any suitable material, including but not limited to paper and paper-like material, woven natural fiber, woven synthetic fiber, and woven blended fiber. The support component of the structural member110can include elastic materials, either in lateral sections of the structural member or as fibers woven into the material of the support component of the structural member110. The elasticity, or lack thereof, of the support component of the structural member can therefore be controlled by choice of material used to construct the support component of the structural member110as well as by modifying sectional construction materials of the support component of the structural member110. Increasing elasticity of the material will tend to decrease with amount of support the mandible support device100can provide to prevent posterior movement of the mandible during sleep. However, increasing the elasticity of the material used for the support component of the structural member110will tend to increase the physical comfort of the mandible support device100for the user. Ideally, the elasticity of the material will allow sufficient force to provide adequate support for the mandible, while still allowing the user to move his or her mandible for, e.g., talking while awake. The degree of support provided by an at least partially elastic mandible support device100can also be adjusted by the user during application of the mandible support device100by the degree to which the structural member110is stretched between the region of epidermis on, behind or beneath the gonial angle to the region about the zygomatic bone.

Turning toFIG. 2, one possible location of application of the mandible support device200is depicted. Mandible support device200comprises a structural member210that comprises a support component and an adhesive component. The first section220of the structural member210has been adhered to the soft tissue above the mandible, such as the epidermis about the zygomatic bone and/or maxilla, by use of the adhesive component of the structural member210. The second section230of the structural member210is situated on, beneath, or behind the gonial angle. In the embodiment depicted inFIG. 2, the first section220of the structural member210contains an adhesive component disposed to the first side of the structural member210in at least a portion of the first section210. The second section230of the structural member210may or may not have an adhesive component disposed on it, depending on the specific application as would be understood be a person of skill in the art.

FIG. 3depicts a perspective view of the placement of two mandible support devices300applied to a user. The structural member310of the mandible support device300is affixed to the user's face and neck. The distal end350of the first section320of the structural member310is affixed temporarily to the epidermis about the zygomatic bone and/or maxilla of the user, taking advantage of the adhesive component of the structural member310. The second section330of the structural member310is disposed about the region on, beneath, or behind the gonial angle. The second section330of the structural member310may be temporarily affixed to the epidermis of the region on, behind or beneath the gonial angle using an adhesive component of the structural member310. However, affixing of the second section330of the structural member310to the epidermis of the region posterior to the gonial angle is not a necessary aspect of the present invention. The distal end370of the third section340of the structural member310is affixed to the epidermis of a portion of the neck running substantially parallel to or along the mandible toward the chin by way of an adhesive component of the structural member310. If the structural member310contains a positioning component390, the positioning component390is situated at the region on, behind, or beneath the gonial angle.

The function of the mandible support device300is to provide passive support to the mandible at the gonial angle to prevent or reduce or restrict a posterior shift of the mandible during sleep when the muscles of the face and the neck are relaxed. The adhesive component of the structural member310anchors the support component of the structural member310on the soft tissue of the face or head above the mandible and the region under and/or posterior to the chin. The placement of the adhesive component of the distal end350of the first section320of the structural member310may be preferentially, though not necessarily, located on or about the zygomatic bone or the maxilla. The weight of the mandible is thereby supported by the first section320of the support component of the structural member310. The third section340of the structural member310stabilizes the position of the second section330of the structural member310, allowing the curve of the second section330of the structural member310to cradle the gonial angle, supporting the mandible and restricting its shift in a posterior direction.

One method of use of the mandible support device300to the face of the user begins with the application of the distal end350of the first section320to the epidermis about the region of zygomatic bone or the maxilla, using the adhesive component that is disposed on the one side of the support component of the structural member310. If the mandible support device300has a positioning component390, the positioning component390should be positioned on, behind, or beneath the gonial angle, such that the curve of the positioning component390approximates the gonial angle. If no positioning component390is present on the structural member310, the second section330of the structural member310should be placed sufficiently on, behind, or beneath the gonial angle so that the structural member310can provide resistance against posterior movement of the mandible. Tension should be applied to the structural member310when bringing to the region on, behind, or beneath the gonial angle. If the second section330of the structural member310is equipped with an adhesive component, tension should be maintained in the first section320of the structural member310while the adhesive component of the second section330is affixed to the epidermis on, behind, or beneath the gonial angle. If the second section330of the structural member310is not equipped with an adhesive component, tension in the first section320and the second section330of the structural member310should be maintained as the structural member is positioned around the region on, behind or beneath the gonial angle and until the distal end370of the third section340of the structural member310is affixed to the epidermis of the neck along the course of the mandible toward the chin. In this method of use of the mandible support device300, the distal end350of the first section320of the structural member310is pulled toward the gonial angle and adhered to the epidermis covering the area about the region under or posterior to the chin using the adhesive component that is disposed on one side of the support component of the distal end370of the third section340of structural member310. It should be noted, of course, that the method of application could also be reversed, so that the distal end370of the third section340of the structural member310is adhered first to the epidermis about the region under or behind the chin, and the structural member is pulled in the posterior direction around the gonial angle and upward toward the region about the zygomatic bone and/or maxilla. Likewise, the second section330could be held against the epidermis on, behind, or beneath the gonial angle while the first section320and the third section340are pulled toward the zygomatic bone and the region under the chin, respectively, and affixed with the adhesive component of the structural member310to their appropriate positions as described herein. In any instance, the force with which the structural member310is pulled behind or beneath the gonial angle will affect the amount of support provided to the mandible. The degree of support provided can therefore be altered depending on the needs of the user, where a greater amount of support can be provided for users that experience a higher degree of posterior mandibular movement during sleep.

In an alternative embodiment based onFIG. 3, the third section340may be substantially elongated beyond what is depicted inFIG. 3such that it is configured to cross under the chin to the opposite side of the face and be adhered to the epidermis about the opposite zygomatic bone or maxilla. Such a configuration would provide an altered degree of support to the mandible.

FIG. 4shows an alternative embodiment of the mandible support device400comprising a structural member410. The structural member410has a first side and a second side, and further comprises a first section420, a second section430, and a third section440. The first section420comprises a first section distal portion450and a first section proximal portion470. The third section440comprises a third section distal portion460and a third section proximal portion475. The first section proximal portion470is coupled to the second section430and the third section proximal portion475is coupled to the second section430. The second section430is shaped and sized to correspond substantially to the shape and size of the gonial angle. The portions of the structural member410that span between the distal ends,450,460, and their respective proximal ends,470,475, can be dimensioned to different width, material, and/or elasticity depending on the specific application technique desired.

FIG. 5shows an alternate embodiment of the mandible support device500. comprising a structural member510. The structural member510has a first side and a second side, and further comprises a first section520, a second section530, and a third section540. The first section520comprises two branches, an anterior branch522and a posterior branch524. The anterior branch522and the posterior branch524are each comprised of a distal portion552and554, respectively, and a proximal portion562and564, respectively. As indicated inFIG. 5, the anterior branch proximal portion562and the anterior branch proximal portion564are coupled at the point where the first section520is coupled to the second section530. The third section540comprises a third section distal portion570and a third section proximal portion580. The first section proximal portion560is coupled to the second section530and the third section proximal portion580is coupled to the second section530. The second section530is shaped and sized to correspond substantially to the shape and size of the gonial angle. Application of this embodiment of mandible support device500on the face of the user would include the application of both the first section anterior branch522and the first section posterior branch524to the soft tissue of the face above the mandible. For instance, in one possible application, the first section anterior branch522would be adhered to the epidermis in the region of the zygomatic bone, while the first section posterior branch524would be adhered to the epidermis in the region of the maxilla. The mandible support device500may include positioning component590.

FIG. 6depicts an alternative embodiment of the invention, in which the mandible support device600is configured to span the distance from the region of the zygomatic bone or maxilla of one side of the face to the region of the zygomatic bone or maxilla of the second side of the face, passing on, behind, or beneath the gonial angle of the first side and the second side of the face. In this embodiment, the structural member610comprises a support component and an adhesive component. The support component of the structural member610comprises a first side and a second side. The support component of the structural member610comprises a first section615, a second section620, a third section625, a fourth section630, a fifth section635, a sixth section640and a seventh section645. The first section615comprises a distal region650and a proximal region655. The third section625comprises a proximal region660and a distal region665. The fifth section635comprises a distal region670and a proximal region675. The seventh section645comprises a proximal region680and a distal region685.

The proximal end655of the first section615is coupled to the second section620and the proximal end of the third section625is coupled to the second section620. The proximal end680of the seventh section645and the proximal end675of the fifth section635is coupled to the sixth section640. The distal end665of the third section625and the distal end670of the fifth section635are coupled to the fourth section630.

The second section620and the sixth section640of the support component of the structural member610are configured to correspond substantially to the shape and size of the gonial angle. The mandible support device600may include positioning components690and695. Each of positioning components690and695are disposed substantially within second section620and sixth section640, respectively. As with the embodiments described above, positioning components690and695may be disposed on the first side or the second side of the support component of the structural member610. Also as discussed with regard to the other example embodiments disclosed herein, the support components690and695serve two principal functions: first, to assist in the correct placement of the mandible support device600; and second, to provide additional support of the mandible, thereby preventing posterior movement of the mandible.

The proximal regions of the first section615and the third section625may be coincident at least to some extent with portions of the second section620, as exemplified in the embodiment depicted inFIG. 6. Similarly, the proximal regions of the fifth section635and the seventh section685may be coincident with portions of the sixth section640, as exemplified in the embodiment illustrated inFIG. 6. The distal regions of the third section625and the fifth section635are disposed about or otherwise linked to portions of the fourth section630.

The structural member610also comprises an adhesive component, with a suitable adhesive as previously discussed herein. As with other exemplary embodiments discussed herein, the adhesive component of the structural member610results from an adhesive layer disposed to the first side of the structural member610. The adhesive component should include an adhesive layer disposed on at least a portion of the distal region650of the first section615, the distal region685of the seventh section645, and either a portion of the fourth section630or a portion of the third section625and the fifth section635. As previously described with regard to other exemplary embodiments disclosed herein, an adhesive layer can be applied to the entire first side of the structural member610, thereby creating an adhesive region over the entirety of the first side of the structural member610. The amount, type, quantity and placement of the adhesive and adhesive layers may be adjusted as appropriate, as would be understood by a person of skill in the art to achieve the function of the mandible support device600.

The positioning components690and695may be used to aid in the positioning of the mandible support device600on the face and neck of the user. The positioning components690and695should be disposed on the structural member610in such a manner that the location of the contours of the positioning components690and695can be felt relative to the gonial angle when the structural member610is applied on the user. The positioning components690and695should be sufficiently flexible, as previously discussed, to be comfortable on the user's epidermis and to be able to conform to the shape and size of the region on, behind or beneath the gonial angle. The positioning components690and695should also be sufficiently rigid to provide some tactile resistance, thus providing tactile feedback to the user (or other individual applying the mandible support device600to the user) regarding the placement of the structural member610relative to the gonial angle.

FIG. 7depicts a perspective view of the placement of a mandible support device700according to one possible embodiment as applied to a user. The structural member710of the mandible support device700is affixed to the user's face and neck. The distal end750of the first section715of the structural member710is affixed temporarily to the epidermis about the zygomatic bone and/or maxilla of the user, taking advantage of the adhesive component of the structural member710. The second section720of the structural member710is disposed about the region on, behind or beneath the gonial angle. The second section720of the structural member710may be temporarily affixed to the epidermis of the region on, beneath, or behind the gonial angle using an adhesive component of the structural member710. However, affixing of the second section720of the structural member710to the epidermis of the region on, beneath, or behind the gonial angle is not a necessary aspect of the present invention. The distal end765of the third section725and the distal end770of the fifth section735, and/or the fourth section730, of the structural member710are affixed to the epidermis covering the neck in the region posterior to the chin by way of an adhesive component of the structural member710. The distal end785of the seventh section745of the structural member710is affixed to the region of the zygomatic bone and/or maxilla of the user, in such an orientation that the sixth section740is disposed about the region on, behind, or beneath the gonial angle. If the structural member710contains positioning components790,795, the positioning components790,795are situated at the region on, beneath, or behind the gonial angle. The method of application of the embodiment depicted inFIGS. 6 and 7to a user would be similar to the method of application of other embodiments disclosed herein.

FIG. 8is an illustration of one embodiment of the present invention. In this embodiment, mandible support device800is depicted as comprising structural member810having a first side and a second side and having a first end820and a second end830. The structural member810may optionally include a positioning component840that may be shaped to approximate the shape and size of the gonial angle. The structural member810contains a support component and an adhesive component. The adhesive component is disposed on at least portions of one side of the support component, substantially near the first end and substantially near the second end. In the current embodiment, it is contemplated that the positioning component840would be optimally located on the side of the support component on which the adhesive component is disposed. However, it should be noted that the positioning component840can be located on either side of the support component, or internally to the support component, near the second end of the structural member if the structural member is thin enough to permit the edges of the positioning component840to be discerned by touch for purposes of placement on, beneath, or behind the gonial angle.

It is contemplated that the adhesive component of the present invention can be any appropriate adhesive known to person of skill in the art, where such adhesive is suitable for use on human skin for temporary adhesion of the support component to the epidermis. In this context, the term “temporary adhesion” is intended to refer to adhesion for a period of time sufficient to span at least 8 to 12 hours, and is removable by the user with minimal discomfort. Such adhesive is contemplated to be a self-adhesive material, an adhesive that must be wetted to exhibit adhesive properties, or any other suitable adhesive known in the art.

FIG. 9illustrates the placement of the mandible support device900on a user. The first end920of the structural member910is adhered to the epidermis covering or near the zygomatic bone and/or the maxilla of the user. The second end930of the structural member910is adhered to the epidermis in the region posterior to the gonial angle of the user.

FIG. 10shows an alternate view of the placement of the mandible support device1000on the user. InFIG. 10, it can be seen that in a preferred application or method of use, two mandible support devices1000are applied to the user, with one located on or about each side of the mandible. InFIG. 10, it can be seen again that the structural member1010of the mandible support device1000is sized to span the distance from the region of the zygomatic bone or maxilla to the region on, behind, or beneath the gonial angle. Specifically, as depicted inFIG. 10, the first end1020of the structural member1010is adhered to the epidermis covering the zygomatic bone and/or maxilla and the second end1030of the structural member1010is adhered to the epidermis covering or about the region on, beneath, or behind the gonial angle. In the embodiment shown inFIG. 10, the mandible support device1000includes a positioning component1040. The positioning component is used to align the second end1030of the structural member1010to the gonial angle. The positioning component1040also provides additional passive support to restrict posterior movement of the mandible.

The support component of the structural member1010can be made of any flexible material upon which the adhesive component can be disposed. Such flexible material may have an elastic quality along all or part of its length, but such an elastic quality is not a requirement of the present invention. Because the structural member1010is intended to be applied to the epidermis of the head, face and/or neck of a human for use during sleep, the adhesive component of the structural member1010should allow for easy removal from the epidermis, while still being able to maintain its position on the epidermis for a period of at least eight to twelve hours. Similarly, because the structural member1010is intended to be applied to the epidermis of the head, face and/or neck of a human, and because the structural member1010is intended to remain in place for periods of time up to or exceeding twelve hours, ideally the material of which the support component of the structural member1010is made will allow for the transmission of moisture and/or air. This “breathability” of the support component of the structural member1010is intended to serve to increase the comfort of the mandible support device to the user.

The support component of the structural member1010may include a section that demonstrates elastic properties, or may be constructed entirely of a material that demonstrates elastic properties. Alternatively, the support component of the structural member1010may comprise an inelastic material. Where the support component of the structural member1010comprises a material that is partially or substantially elastic along its length, the elasticity should not be so great as to eliminate the substantial passive support of the mandible that is necessary for the proper functioning of the mandible support device1000.

The mandible support device1000serves to provide passive support of the mandible, overcoming, at least in part, the reduction in muscular support that occurs as a result of the relaxation of muscles of the face and neck during sleep. The support component of the structural member1010of the mandible support device1000is anchored to the soft tissue of the region over or about the zygomatic bone and/or maxilla by contacting the adhesive component on one side of the first end1020of the support component of the structural member1010to the epidermis in the region of the zygomatic bone and/or maxilla, thereby adhering the first end1020of the structural member1010to the epidermis in the region of the zygomatic bone and/or maxilla. The second end1030of the structural member1010is then adhered to the skin covering the region immediately posterior to the gonial angle.

One of skill in the art would understand that the application positioning of the first end1020of the structural member1010can vary from user to user, or can vary about the face of the user while still performing the function of the invention. For example, depending on the material used for the structural member1010, the adhesive material, and the geometry of a user's face, it may be determined that the optimal position of the first end1020of the structural member1010may be somewhat anterior to the zygomatic bone of the user, rotated in the direction of the user's nose.

A positioning component1040can be used to aid in the positioning of the second end1030of the structural member1010to the region on, behind, or beneath the gonial angle. The positioning component1040should be disposed on the structural member1010in such a manner that the location of the contours of the positioning component1040can be felt relative to the gonial angle when the structural member1010is applied on the user. The positioning component1040should be sufficiently flexible to be comfortable on the user's epidermis and to be able to conform to the shape and size of the region on, beneath, or behind the gonial angle. The positioning component1040should also be sufficiently rigid to provide some tactile resistance, thus providing tactile feedback to the user regarding placement of the second end1030of the structural member1010relative to the gonial angle.

The positioning component1040has an additional function of providing support to the mandible and reducing a shift of the mandible in a posterior direction. Specifically, the positioning component1040when adhered to the epidermis covering the head, face or neck on, behind or beneath the gonial angle provides a ledge-like structure against which the gonial angle can rest upon relaxation of the facial and neck muscles, thereby aiding in the prevention of a posterior shift of the mandible.

Returning toFIG. 8, in an alternative embodiment, one or more rib members850can be embedded within or otherwise disposed on the structural member810of the mandible support device800. The rib member850may comprise one or more strips of rigid or semi-rigid material. Rib member850may comprise metal, plastic, or any other suitable material as would be understood by a person of skill in this art to perform the necessary function. The rib member850would provide support for the shape of the structural member810in a longitudinal direction, from the first end820to the second end830, allowing the structural member810to maintain a shape approximating the shape of a human neck and face over the span from the region above the mandible to the region on, behind, or beneath the gonial angle. The shape of the rib member850may be fashioned such that when applied to the epidermis of the neck and face, the rib member850provides a force inward to the face and neck to bring the positioning component840in closer alignment with the gonial angle. The inward force immediately posterior to the gonial angle can provide additional support for the mandible by allowing the positioning component840to more effectively resist movement of the mandible in the posterior direction along the longitudinal axis of the structural member810. The rib member850may also be configured to pass between the positioning component840and the structural member810, as indicated at region860. However, such a configuration is only one of several configurations that would be understood by a person of skill in the art.

One method of application of the mandible support device800to the face of the user begins with the application of the second end830to the skin in the region on, beneath, or behind the gonial angle, using the adhesive component that is disposed on the one side of the support component of the structural member810. If the mandible support device800has a positioning component840, the positioning component840should be positioned directly on, beneath, or behind the gonial angle, such that the curve of the positioning component840approximates the gonial angle. If the mandible support device800includes one or more semi-rigid members850, the end of the structural member810should be affixed to the epidermis on, behind, or beneath the gonial angle such that positioning component840, if present, is allowed to press slightly inward at its location beneath or behind the gonial angle. If no positioning component840is present on the structural member810, the second end830of the structural member810should be placed sufficiently beyond the gonial angle so that the structural member810can provide resistance against posterior movement of the mandible. In this method of use of the mandible support device800, the first end820of the structural member810is pulled toward the zygomatic bone and/or maxilla and adhered to the epidermis covering the area of the zygomatic bone and/or maxilla using the adhesive component that is disposed on one side of the support component of the structural member810. The force with which the first end820of the support component of the structural member810is pulled beneath or behind the gonial angle and toward the zygomatic bone and/or maxilla will affect the amount of support provided to the mandible. The degree of support provided can therefore be altered depending on the needs of the user, where a greater amount of support can be provided for users that experience a higher degree of posterior mandibular movement during sleep. Certainly, application of the mandible support device800to the user can be accomplished by adhering the first end820of the structural member810to the region of the zygomatic bone first, followed by pulling the second end830of the structural member810toward the gonial angle and adhering the second end830of the structural member810to the epidermis covering the region of the face and neck on, beneath, or behind the gonial angle. However, because the positioning of the second end830of the structural member810is of primary importance to the most effective application of the mandible support device800, the preferred method of use entails first adhering the second end830of the structural member810to the soft tissues covering the region on, behind, or beneath the gonial angle.

Other and further embodiments utilizing one or more aspects of the inventions described above can be devised without departing from the spirit of Applicant's invention. Further, the various methods and embodiments of the mandible support device can be included in combination with each other to produce variations of the disclosed methods and embodiments. Discussion of singular elements can include plural elements and vice-versa.