HK1159465B - Mandibular advancement device with positive positioning hinge - Google Patents

Description

Mandibular advancement device with positive positioning hinge

Cross Reference to Related Applications

This application claims priority to provisional patent application No. 61/195,171 filed on 3/10/2008.

Technical Field

The present invention relates to devices for preventing sleep problems including snoring and sleep apnea. In particular, the device is an oral appliance that alters the position of the user's jaw. It is known that advancing the mandibular oral structure position relative to the maxillary oral structure position is a method of reducing snoring and sleep apnea by reducing the restriction of air flow through the pharyngeal passageway. The reduction in air flow restriction reduces the vibration of the soft tissue causing snoring and reduces the occlusion causing sleep apnea.

Background

Snoring and sleep apnea have been recognized as sleep problems affecting the quality of life in many people. Snoring is typically caused by vibration of the soft tissue and tongue against the back of the larynx, which can be caused by restricted airflow through the pharyngeal passage. Both the snoring person and other persons nearby are affected by the generated noise.

Relaxation of the muscles during sleep causes the structures and tissues of the nose and mouth to fall back against the posterior wall of the larynx. While partial airflow limitation causes snoring, a more complete obstruction causes sleep apnea, also known as Obstructive Sleep Apnea (OSA). OSA causes short periods of respiratory arrest, which causes the patient to wheeze, causes changes in muscle contraction and causes significant interruptions in sleep patterns. Due to the low quality of sleep, patients may experience fatigue-induced problems such as daytime sleepiness, depression, and other related problems. Reduced airflow and reduced oxygen saturation may also be associated with more serious complications such as myocardial infarction or heart beat.

Thus, opening the pharyngeal passageway to increase airflow during sleep eliminates or significantly reduces snoring and OSA, and the resulting effect is significant.

There are currently a number of approaches to prevent snoring and/or OSA. One approach is the advancement of the mandibular structure relative to the maxillary structure. It has been established since the 19 th century that advancing the mandible results in increased airflow through the pharyngeal passageway. Thus, advancing the mandible while sleeping can reduce or eliminate snoring and/or OSA.

Description of the Related Art

There are currently a number of devices that advance the mandible position and thus prevent snoring and OSA. These devices are all in the form of oral appliances worn by the user while sleeping. However, all of these previously known devices suffer from certain limitations. One common limitation is that custom shaping is often required to conform the shape of the device to the user's teeth or mouth. This requires specialized skills of medical professionals, such as dentists, and is therefore expensive and time consuming. In addition, many devices limit the physiological movements of the user when placed in the mouth, and do not freely open and close their jaws. This is uncomfortable and unnatural for many users. The upper and lower trays of various devices force the jaw in a fixed, nearly closed or closed position. Devices designed not to allow complete closure may assist the flow of air through the mouth.

US 6,129,084(Bergersen) describes an intraoral device for advancing the mandible of a user. The device comprises two u-shaped plates which are connected to form a hinge. The lower plate includes a channel. The lower plate channel has an inner wall (lingual wall) facing the tongue of the user and an outer wall (labial-buccal wall) facing the cheeks and lips of the user. Thus, the user's mandibular teeth rest within the lower channel. The upper panel comprises an outer wall (labial-buccal wall) but does not comprise an inner wall (lingual wall). The lack of an inner wall is to position the user's tongue in contact with the lingual side of the user's maxillary teeth, meaning with the inner side of the user's upper teeth. The preferred embodiment of the device is molded from a single piece of flexible material and uses a simple hinge mechanism. The hinge is simply constructed of a thinned cross section of molded material that allows the device to bend. The patent also describes that the hinge can be sufficiently rigid to maintain a substantial gap in the open position even if a substantial force is applied by the user.

However, the us 084 device suffers from a number of limitations. This simple hinge mechanism is subject to wear as the pliable material is bent through the many cycles of opening and closing of the user's mouth. The mandibular advancement provided by this device is achieved solely by the position of the hinge. Fatigue of the material, coupled with the lack of mechanical reinforcement, may cause the simple living hinge to become loose and loose, rendering the device unable to properly advance the mandible. Furthermore, there are no mechanical elements to prevent the device from closing completely so that the upper surface 24 and the lower surface 14 become the same plane.

US 6,055,986(Meade) describes a mandibular advancement mouthpiece comprising a hard shell holding a soft, moldable material. The soft material is placed against the teeth. The device is made in two main halves: an upper member and a lower member. One embodiment includes complementary surfaces 222 and 224 that cooperate to fix the relative forward and rearward positions of the upper and lower members relative to each other. However, with this device, the upper and lower members are not connected or hinged to each other. Rather, the device relies on the material molded to the user's individual teeth and the resulting contact bond to remain in place within the mouth.

US 6,170,485 (orico) also describes a system with two halves. The system also uses a moldable inner tray to interface with the teeth. The system also depicts tongues 30 and 32 extending out of the person's mouth. One tongue includes a plurality of apertures 34 and the other tongue includes a protrusion 36. The protrusion is aligned with one of the holes to achieve mandibular advancement, with different holes providing different amounts of advancement. However, with this device, the upper and lower members are not connected or hinged to each other. Rather, the device relies on the material molded to the user's individual teeth and the resulting contact bond to remain in place within the mouth.

US 5,829,441(Kidd) also describes a system with two halves. The system also uses a moldable material to interface with the teeth and includes means for adjustably advancing the user's mandible. However, this device requires the user to have their jaw in a fixed clenching position while sleeping. Many people find it uncomfortable to sleep with their jaw in a fixed position, and may even suppress sleep.

US 6,516,805(Thorton) and its related patent applications also describe a system having two halves. The system also uses moldable materials to interface with the teeth. A post 16 extends from the upper arch 12 and contacts the lower arch 14 to extend the user's mandible. However, the two half design requires the post to be placed in front of the upper arch. Thus, when the mouth is open, the post may disengage from the lower arch, leaving the mandible no longer in the advanced position. Furthermore, there are no mechanical elements to prevent the device from closing completely so that the upper arch and the lower arch become the same plane.

US 5,499,633(Fenton) describes a system with two halves. The system includes apertures 40 and protrusions 36. The projections are received in the apertures, thereby extending the mandible. However, with this device, the upper and lower members are not fixedly connected or hinged to each other. The protrusions are made from the soft, moldable material of the device and as such may be difficult to fit within the apertures. Furthermore, the soft material of each protrusion may allow movement between the upper and lower members, thus failing to consistently advance the mandible. In addition, the two members of the device may be easily disengaged from the teeth by natural movement of the jaw. The device also requires boiling and molding.

US 1,146,264(Kelly) describes a dental splint. It will be clearly understood that the device uses two separate trays to hold the jaw in place, the trays being apparently cemented to the user's teeth. If the jaw bone is fractured and must be treated, a static position is created using the device. The device has a post 18 which holds the tray body in spaced apart relation so that food can be inserted into the user's mouth.

US 4,376,628(Aardse) describes a dental treatment mechanism divided into two halves. The mechanism comprises parallel ridges 9 and 10. These ridges serve to center one device half on the other. The orientation of the ridges does not advance the mandible as they are in a direction perpendicular to the direction required for mandibular advancement.

CA 2,177,284(Voss) describes a one-piece mandibular advancement device. The device is molded from a single piece of flexible material and uses a simple hinge mechanism. Hinges 4 and 4' are formed of a thinned cross section of molded material and incorporate a semi-cylinder 40 and a notch 41. This assembly enables the device to bend. However, this device suffers from various limitations. This simple hinge mechanism is subject to wear as the pliable material is bent through the many cycles of opening and closing of the user's mouth. The mandibular advancement provided by this device is achieved solely by the position of the articulation and is limited similarly to the device described in' 084 (Bergersen). Furthermore, there are no mechanical elements to prevent the device from closing completely such that the upper surface 24 and the lower surface 14 become coplanar and thus restrict airflow through the mouth.

Other mandibular devices are also disclosed in other patents and on the market. However, they are all subject to similar limitations as the above-described invention. In general, many of the above devices require fitting, molding and adjustment by dental professionals and in manufacturing laboratories. This process is costly and time consuming and prevents non-skilled personnel from directly unpacking the device for use. Other systems employ simple articulations that wear rapidly and may no longer properly advance the mandible. Many of these devices also restrict the user from opening his/her mouth, which many users find undesirable.

Disclosure of Invention

Several objects and advantages of the present invention will become more apparent. The claimed mandibular advancement device is not required to be fitted, heated, molded or adjusted to be usable. Further, there is a need for a device that is durable, convenient to wear, and simple to use. The device should be comfortable and allow the user to freely open and close his/her mouth so as not to impede natural jaw movement. Furthermore, there is a need for a device that can be unpackaged directly by unskilled persons, eliminating the need for costly and time consuming fittings by dental professionals and in manufacturing laboratories.

In a preferred embodiment of the invention, the single piece device is made of a material such as KratonIs molded from a flexible thermoplastic elastomer. The device comprises an upper jaw plate body and a lower jaw plate body which are connected by a hinge mechanism. Both the upper and lower trays include inner and outer walls that increase the contact area with the teeth. The lingual surface of the mandibular tray has a flange that extends downwardly into the lingual vestibule to provide a greater contact area to advance the mandible. The flange is designed to have a length that extends into the vestibule of the tongue, but does not contact the lingual band.

The articulating mechanism of the preferred embodiment includes a positive positioning system of opposing interlocking ridges. The ridges serve to effect and maintain the offset between the relative positions of the upper and lower trays to each other, thus advancing the user's mandible. The positioning of the ridges close to the hinge point is also advantageous, since the ridges continuously engage each other and thus enable the mandible to be advanced even when the jaw is almost fully open. Furthermore, the ridges are self-aligning and fit easily, with substantially no possibility of jamming.

The preferred embodiment also includes a post located near the front of the upper tray and the lower tray. These posts form an air gap that prevents the upper and lower trays from closing completely against each other. The preferred embodiment is also contoured and curved to fit comfortably within the mouth and over the teeth. Related to the contouring is a slotted notch on the anterior superior portion of the maxillary tray to avoid friction and irritation to the connective tissue on the medial side of the upper lip (maxillary labial frenulum).

Drawings

Fig. 1 is a perspective view of the device in an open position when not in the mouth of a user.

Fig. 2a is a top view of the device.

Fig. 2b is a bottom view of the device.

Fig. 3a is a right side view of the device.

Fig. 3b is a left side view of the device.

Fig. 4a is a rear view of the device.

Fig. 4a is a front view of the device.

Fig. 5 is a bottom view of the front of the lower tray of the device.

Fig. 6 is a perspective view of the front of the lower tray of the device.

Explanation of reference numerals

10 Overall arrangement

12 maxillary plate body

14 mandible tray body

Inner wall of 16a maxillary disc

Outer wall of 16b maxillary disc

Inner wall of 18a mandible tray

Outer wall of 18b mandible tray

Lingual flange portion of inner wall of 18c mandibular tray body

20a right column

20b left column

21a right holding column

21b left holding column

22a hinged right overall

22b hinged left part overall

24a front upper interlocking ridge right

24b rear upper interlocking ridge right

24c lower interlocking ridge right

26a front upper interlocking ridge left

26b rear upper interlocking ridge left

26c lower interlocking ridge left

28a Flexible hinge part Right part

28b flexible hinge part left part

32 outer disc body wall chamfer

34 curved contour of maxillary disc

Curved profile of 36 mandible plates

38 gap profile

40 tooth retention tab

Detailed Description

In all the figures, the open position of the device is shown when not in the user's mouth.

Fig. 1 is a perspective view of a preferred embodiment of the invention. As shown, the single piece overall device 10 is folded at an overall hinged right portion 22a and an overall hinged left portion 22 b. The maxillary tray 12 and the mandibular tray 14 are both u-shaped and are joined together by hinges 22a and 22 b. The length of the upper and lower trays is preferably designed so that the device, when fully inserted, extends back to the center of the upper first molar. This allows sufficient contact between the tray and the teeth to hold the device in place, but does not extend too far into the mouth to cause discomfort or encourage vomiting.

Figure 1 also shows the interlocking ridges of each hinge. The front upper interlocking ridge right portion 24a, the rear upper interlocking ridge right portion 24b, and the lower interlocking ridge right portion 24c collectively form a positive mating system. The preferred embodiment uses trapezoidal cross-section ridges. This shape forms a chamfered profile that conveniently engages the lower ridge 24c with the upper ridges 24a and 24b when the device is closed. The same is true of the left hinge 22 b. The molded material is thinnest in cross-section at the flexible hinge portion right portion 28a and the flexible hinge portion left portion 28b of the overall device. The reduced cross-section allows the device to flex and bend like a hinge. The hinge also acts as a low force spring whose force assists in maintaining the upper tray 12 in contact with the user's maxillary teeth and the lower tray 14 in contact with the user's mandibular teeth.

Fig. 1 also shows a right post 20a and a left post 20 b. These posts prevent the maxillary tray 12 and mandibular tray 14 from closing fully against each other. Of course, the posts may be placed at other locations on the device, such as the same locations on the tray 14. The posts 20a and 20b may be located at different positions on either tray, but the illustrated positions provide the advantage of a more desirable positioning to maintain airflow. The right retaining post 21a and left retaining post 21b function similarly to posts 20a and 20 b. All columns are also used for: the additional support provided to each column on its respective tray when in contact with its opposing tray minimizes flexing and bending of its respective tray and corrects for overall angular rotation.

Fig. 2a is a top view of the device further showing the location of all interlocking ridges and all posts.

Fig. 2b is a bottom view of the device, further illustrating the tooth retention tabs 40.

Fig. 3a is a right side view of the device further showing the interlocking ridges and the location of one side of the post, and also showing the outer wall of the maxillary tray 16b, the inner wall of the mandibular tray 18a, and the outer wall of the mandibular tray 18b, and also showing the outer tray wall chamfer 32, the curved profile of the maxillary tray 34, and the curved profile of the mandibular tray 36. Reference numeral 18c shows a lingual flange portion of the inner wall of the mandibular tray body. The flange 18c is intended to extend into the user's lingual vestibule to provide a greater contact surface for advancement of the mandible.

Fig. 3b is a left side view of the device showing a similar structure to fig. 3 a.

Fig. 4a is a rear view of the device.

Fig. 4b is a front view of the device. The slot profile 38 is visible in this figure.

Fig. 5 is a bottom view of the front of the lower tray of the device. In this view, the tooth retention tabs 40 are visible.

Fig. 6 is a perspective view of the front of the lower tray of the device. In this view, the tooth retention tabs 40 are visible.

The overall device 10 is susceptible to bending in half at the hinges 22a and 22 b. And then inserted into the user's mouth so that the user's maxillary teeth press into maxillary tray 12 and the user's mandibular teeth press into mandibular tray 14. The user's maxillary teeth are held by the inner wall of the maxillary tray 16a and the outer wall of the maxillary tray 16 b. The user's mandibular teeth are in contact with the inner wall 18a of the mandibular tray 14 and, in addition, the outer wall 18b of the tray 14 may be in contact with the maxillary teeth. The opposing force in contact with the surfaces of the maxillary dentition, and in particular the inner flange of tray 18a in contact with the lingual surfaces of the lower lingual dentition, maintains the lower jaw in a forward position relative to the upper jaw, thereby maintaining the airway passages in the nasopharynx, oropharynx and throat substantially free of obstruction, thus reducing or eliminating snoring and/or OSA.

The position or offset of the two discs relative to each other is determined by the positioning of the overall hinges 22a and 22 b. The offset is further enhanced by the pairs of hinge ridges 24a, 24b, 24c and 26a, 26b, 26 c. The ridged hinges cooperate and further enhance the amount of deflection as the device is bent and placed into the mouth of the user. The ridges continue to mate when the user partially or even fully opens his/her mouth. The positioning of the ridges near the hinge point allows the ridges to remain engaged over a wider range of oral movements than if the ridges were positioned closer to the front of the overall device. It is therefore advantageous to include the ridges within the hinge portion of the overall device. In addition, the interlocking ridges help prevent lateral and rotational movement between the upper and lower trays, thereby maintaining alignment.

In the preferred embodiment, right and left lower interlocking ridges 24c and 26c, respectively, may be formed such that the highest point of each ridge is coplanar with the larger planar surface of mandibular tray 14. This effectively forms a small recess for each ridge 22a and 22b to fit within, thereby forming a more positive fit, which helps ensure that the required mandibular advancement is achieved. Alternatively, the ridges 24c and 26c may be more simply formed so that they project above the planar surface of the tray 14.

Although the preferred embodiment is shown as a single piece, living hinge design, other types of hinge designs may be employed. In other embodiments, the upper and lower trays may be made as separate pieces and joined together by separate hinges. Alternatively, the articulating mechanisms may be made of the same or completely different types of materials, including but not limited to alloys, metals, plastics, polyethylene, and the like.

Another inventive element of the preferred embodiment is two airflow posts 20a and 20b located near the anterior portion of the maxillary tray 12. These posts form an air gap that prevents the flat surfaces of the upper tray 12 and lower tray 14 from closing completely against each other. This ensures that air will flow through the user's mouth even if the teeth are tightly occluded while sleeping.

Optionally including a right retaining post 21a and a left retaining post 21 b. The posts 21a and 21b are shown on the lower chin cup 14. When the device of the present invention is placed in the user's mouth in the closed position, the posts 21a and 21b help ensure that the mandible remains in the advanced position by engaging against the posts 20a and 20b, thereby further preventing the lower tray 14 from moving rearwardly relative to the upper tray 12.

Another inventive element that may optionally be included is a tooth retention tab 40. The tab is located on the inner wall of mandible tray 14, in the position shown in fig. 6 and 5. The tab is positioned and shaped so that it interfaces with the lingual surface of the mandibular central incisors. The naturally curved lingual surfaces of the mandibular central incisors mate with the retention tabs, which helps to keep the mandibular tray positioned over the teeth and helps to prevent the tray from sliding out of and disengaging from the teeth.

The preferred embodiment is also contoured and curved to fit comfortably within the mouth and over the teeth. The edges of both the upper and lower trays are chamfered or otherwise made non-sharp so as to be comfortable in the mouth of the user. Associated with the contouring is a crevice contour 38 on the anterior superior portion of the maxillary tray 12 to avoid friction and irritation to the connective tissue on the medial side of the upper lip. Also, the wall thickness of the device can vary from place to form an optimal shape for comfort while maintaining durability.

In the preferred embodiment, the device is made of a material such as KratonA suitable material such as a polymer is molded. KratonThe polymer provides additional comfort and cushioning to the user. The rubbery nature of the polymer increases the amount of surface tension and contact adhesion to the teeth and prevents the device from falling out during use. Compared with the conventional resin on the market at present, KratonThe polymer will wear better for longer periods of time. Specifically, DynaflexThermoplastic elastomers provide the present invention with superior properties. Of course, other suitable materials may be used, either in the form of synthetic polymers or even natural rubber.

Although the overall device is primarily intended for the purpose of mandibular advancement, with sleep related benefits, the device is also intended to alleviate problems associated with bruxism or biting. This mechanism is readily apparent for this purpose because the upper and lower trays prevent the maxillary and mandibular teeth from making direct contact.

The above elements combine to form a mandibular advancement device that does not require custom fitting and is easy to use in the field. While the above description and the associated drawings describe particular embodiments of the invention, these should not be construed as limiting the scope of the invention to these particular elements. The interpretation of the scope of the invention should be determined by the claims and their legal equivalents.

Claims (16)

1. A mandibular advancement device comprising:

the upper jaw plate body comprises an inner wall and an outer wall;

the lower jaw plate body comprises an inner wall and an outer wall;

two articulating mechanisms connecting a rearmost portion of the upper maxillary tray to a rearmost portion of the lower mandibular tray on an axis, interlocking ridges in the articulating mechanisms positioned to create a bias between the upper maxillary tray and the lower mandibular tray when the upper and lower maxillary trays are folded about the axis, interlocking ridges in the articulating mechanisms further engaging the lower mandibular tray with the upper maxillary tray, the interlocking ridges positioned proximate to the articulating point.

2. The device of claim 1 further comprising a slot profile on said maxillary tray.

3. The device of claim 1 further comprising tooth retention tabs on an inner wall of the mandibular tray.

4. The device of claim 1, wherein the device is made of a thermoplastic polymer.

5. The device of claim 1 wherein the articulating mechanism also acts as a spring, the force of the spring assisting in maintaining the maxillary tray in contact with the user's maxillary teeth and the mandibular tray in contact with the user's mandibular teeth.

6. The device of claim 1 wherein said inner wall of said mandibular tray body includes a flange portion such that in use said flange extends into the lingual vestibule of the user to provide a greater contact area for advancing the mandible.

7. The device of claim 1 wherein when the device is fully inserted, the maxillary and mandibular trays extend to the center of the user's upper first molars.

8. The device of claim 1, further having an effect for alleviating bruxism.

9. A mandibular advancement device comprising:

the upper jaw plate body comprises an inner wall and an outer wall;

the lower jaw plate body comprises an inner wall and an outer wall;

two articulating mechanisms connecting a rearmost portion of the upper maxillary tray to a rearmost portion of the lower mandibular tray on an axis, interlocking ridges in the articulating mechanisms positioned to create a deviation between the upper maxillary tray and the lower mandibular tray when the upper and lower maxillary trays are folded about the axis, interlocking ridges in the articulating mechanisms further engaging the lower mandibular tray with the upper maxillary tray, the interlocking ridges positioned proximate to an articulating point;

a plurality of posts to prevent the planar surface of the maxillary tray from closing completely against the planar surface of the mandibular tray.

10. The device of claim 9 further comprising a slot profile on said maxillary tray.

11. The device of claim 9 further comprising tooth retention tabs on an inner wall of the mandibular tray.

12. The device of claim 9, wherein the device is made of a thermoplastic polymer.

13. The device of claim 9 wherein the articulating mechanism also acts as a spring, the force of the spring assisting in maintaining the maxillary tray in contact with the user's maxillary teeth and the mandibular tray in contact with the user's mandibular teeth.

14. The device of claim 9 wherein the inner wall of the mandibular tray body includes a flange portion such that, in use, the flange extends into the lingual vestibule of the user to provide a greater contact area for advancing the mandible.

15. The device of claim 9 wherein when the device is fully inserted, the maxillary and mandibular trays extend to the center of the user's upper first molars.

16. The device of claim 9, wherein the device further has an effect for alleviating bruxism.