WO2011146419A1

WO2011146419A1 - Oral appliance with adjustment assembly

Info

Publication number: WO2011146419A1
Application number: PCT/US2011/036714
Authority: WO
Inventors: Kent Moore
Original assignee: Kent Moore
Priority date: 2010-05-18
Filing date: 2011-05-17
Publication date: 2011-11-24

Abstract

Embodiments of the present invention are related to oral appliances and methods for treating sleep disorders. In one embodiment, the oral appliance (10) includes an upper housing (20) with at least one upper flange (25) and a lower housing (30) with at least one lower flange (35). The upper and lower housing are configured to releasably attach to at least a portion of the upper and lower jaw, respectively, and to engage one another to advance the lower jaw relative to the upper jaw. The oral appliance further comprises an anterior adjustment mechanism (15) coupled to the upper or lower housing and a corresponding upper or lower flange such that adjustment of the anterior adjustment mechanism adjusts the position of the upper or lower flange so as to control the degree of advancement of the lower jaw relative to the upper jaw.

Description

ORAL APPLIANCE WITH ADJUSTMENT ASSEMBLY

FIELD

Embodiments of the present invention discussed herein are related to oral appliances structured for mandibular advancement. Such devices have application in treatment of various sleep disorders, such as snoring and obstructive sleep apnea.

BACKGROUND

Many people have difficulty breathing properly, which can result in various sleep disorders. These sleep disorders may be common snoring or more serious conditions, like obstructive sleep apnea. It is generally thought that snoring or obstructive sleep apnea occurs when a person's tongue at least partially obstructs the airway. One treatment for keeping the tongue from obstructing a person's airway is with a mandibular advancement device. These devices are inserted into a person's mouth and act to advance the lower jaw, and thus the tongue, forward to open the airway for better breathing.

Oral appliances that utilize mandibular advancement devices can be bulky and cumbersome to wear. Moreover, some devices may require a doctor to perform the adjustment. Further, some oral appliances with mandibular advancement devices require adjustment at two separate locations on either side of the mouth. Thus, if adjustment is not exactly the same on each side, the positioning of the user's upper and/or lower jaw can become skewed. Moreover, since the location of the adjustment is likely in the back of a user's mouth, it can be difficult to perform the adjustment without removing the appliance from the user's mouth. Therefore, despite the use of such mandibular advancement devices, improvements are needed in order to more effectively treat sleep disorders as well as provide an easier to use device. BRIEF SUMMARY OF THE INVENTION

As such, embodiments of the present invention are related to oral appliances and methods for treating sleep disorders. In one embodiment, an oral appliance includes an upper housing comprising an anterior portion and a posterior portion located remotely from the anterior portion. The upper housing is configured to releasably attach to at least a portion of the upper jaw. The upper housing comprises at least one upper flange proximate to the posterior portion. The oral appliance further comprises a lower housing with an anterior portion and a posterior portion located remotely from the anterior portion. The lower housing is configured to releasably attach to at least a portion of the lower jaw and comprises at least one lower flange proximate to the posterior portion. The upper flange and lower flange are configured to engage one another to advance the lower jaw relative to the upper jaw. The oral appliance further comprises an anterior adjustment mechanism coupled to the upper or lower housing and a corresponding upper or lower flange such that adjustment of the anterior adjustment mechanism adjusts the position of the upper or lower flange so as to control the degree of advancement of the lower jaw relative to the upper jaw.

In another embodiment, an adjustment assembly for use with an oral appliance is provided. The assembly comprises an anterior adjustment mechanism, at least one posterior adjustment mechanism, and at least one rotatable wire coupled to the anterior adjustment mechanism and the posterior adjustment mechanism. The anterior and posterior adjustment mechanisms are coupled to the upper and/or lower jaws such that rotation of the wire engages the posterior adjustment mechanism resulting in a positional adjustment of the upper and lower jaws with respect to one another.

In another embodiment, a method of treating sleep disorders is provided. The method comprises releasably attaching an upper housing to at least a portion of the upper jaw. The upper housing comprises an anterior portion and a posterior portion located remotely from the anterior portion. The upper housing further comprises at least one upper flange proximate to the posterior portion. The method further comprises releasably attaching a lower housing to at least a portion of the lower jaw. The lower housing comprises an anterior portion and a posterior portion located remotely from the anterior portion. The lower housing further comprises at least one lower flange proximate to the posterior portion, wherein the upper flange and lower flange are configured to engage one another to advance the lower jaw relative to the upper jaw. The method further comprises adjusting an anterior adjustment mechanism coupled to an anterior portion of the upper or lower housing and the at least one upper or lower flange so as to adjust the position of the at least one upper or lower flange and control the degree of advancement of the lower jaw relative to the upper jaw.

Some embodiments of the present invention may provide several advantages. For example, an oral appliance with an adjustment assembly as described in some embodiments of the present invention may allow for a single adjustment location that maintains proper and balanced alignment of a user's upper and lower jaw. For example, in some embodiments, an oral appliance may contain an anterior adjustment mechanism that is readily accessible such that the oral appliance may be adjusted while being positioned inside a user's mouth. According to one embodiment of the present invention, the oral appliance utilizes an easily accessible and adjustable anterior adjustment mechanism which facilitates adjustment of one or more wires at the same time and/or rate, thus, simultaneously adjusting the position of the flanges or engagement members. Thus, adjustment of the anterior adjustment mechanism allows for uniform advancement of the jaw. Additionally, embodiments of the present invention may provide an oral appliance with an adjustment assembly substantially contained within an acrylic shell for comfort during use such that the device will allow changes in degree of mandibular protrusion while the device is in the mouth.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Having thus described the invention in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein:

FIG. 1 is a perspective view of an oral appliance with an adjustment assembly, in accordance with some embodiments discussed herein;

FIG. 2 is a top view of a portion of an oral appliance with an adjustment assembly, in accordance with some embodiments discussed herein;

FIG. 3 is a top view of an adjustment assembly, in accordance with some embodiments discussed herein; FIG. 4 is a detail view of an anterior adjustment mechanism, in accordance with some embodiments discussed herein;

FIG. 5 is a detail view of a posterior adjustment mechanism, in accordance with some embodiments discussed herein;

FIG. 6 is a detail view of a posterior adjustment mechanism, in accordance with some embodiments discussed herein;

FIG. 7 is a cross-sectional view of a posterior adjustment mechanism, in accordance with some embodiments discussed herein;

FIG. 8 is a front view of an oral appliance, in accordance with another embodiment of the present invention;

FIG. 9 is a top view of the oral appliance shown in FIG. 8, in accordance with some embodiments discussed herein;

FIG. 10 is a detail view of a posterior adjustment mechanism configured for use with the oral appliance shown in FIG. 9, in accordance with some embodiments discussed herein; and

FIG. 11 is a detail view of a posterior adjustment mechanism configured for use with the oral appliance shown in FIG. 9, in accordance with some embodiments discussed herein;

FIG. 12 is a side view of an upper and lower housing for the oral appliance shown in FIG. 9, in accordance with some embodiments discussed herein;

FIG. 13 is a top view of a lower housing of an oral appliance with an adjustment assembly, in accordance with some embodiments discussed herein;

FIG. 14 is a top view of an upper housing of an oral appliance with an adjustment assembly, in accordance with some embodiments discussed herein;

FIG. 14A is a side view of the upper housing shown in FIG. 14 in engagement with a lower housing, in accordance with some embodiments discussed herein;

FIG. 14B is a cross-sectional view of the upper housing shown in FIG. 14 and a posterior adjustment mechanism, in accordance with some embodiments discussed herein;

FIG. 14C is a cross-sectional view of the portion of the upper housing shown in

FIG. 14B, in accordance with some embodiments discussed herein;

FIG. 15 is a side view of an oral appliance with an adjustment assembly, in accordance with some embodiments discussed herein; FIG. 15A is a detail perspective view of the anterior adjustment mechanism of the oral appliance shown in FIG. 15, in accordance with some embodiments discussed herein;

FIG. 15B is a detail perspective view of the adjustment wire of the oral appliance shown in FIG. 15, in accordance with some embodiments discussed herein;

FIG. 15C is a detail perspective view of the posterior adjustment mechanism of the oral appliance shown in FIG. 15, in accordance with some embodiments discussed herein;

FIG. 16 is a front view of the oral appliance shown in FIG. 15, in accordance with some embodiments discussed herein;

FIG. 17 is a side view of the oral appliance shown in FIG. 15 engaged with an upper and lower jaw of a user, in accordance with some embodiments discussed herein;

FIG. 18 is a side view of the oral appliance shown in FIG. 15 engaged with an upper and lower jaw of a user, wherein the adjustment assembly has been extended to displace the lower jaw relative to the upper jaw, in accordance with some

embodiments discussed herein;

FIG. 19 is a side view of an oral appliance with an adjustment assembly, in accordance with some embodiments discussed herein;

FIG. 19A is a top view of the oral appliance shown in FIG. 19, in accordance with some embodiments discussed herein;

FIG. 20 is a side view of the oral appliance shown in FIG. 19, wherein the adjustment assembly is extended to displace the lower housing relative to the upper housing, in accordance with some embodiments discussed herein;

FIG. 20A is a top view of the oral appliance shown in FIG. 19, wherein the adjustment assembly is extended to displace the lower housing relative to the upper housing, in accordance with some embodiments discussed herein;

FIG. 21 is a side view of an oral appliance with an adjustment assembly, in accordance with some embodiments discussed herein; and

FIG. 22 is a side view of an oral appliance with an adjustment assembly configured to vertically displace the upper housing relative to the lower housing, in accordance with some embodiments discussed herein. DETAILED DESCRIPTION

The present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the inventions are shown. Indeed, these inventions may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout.

According to one embodiment, FIG. 1 shows an oral appliance 10 configured for mandibular advancement. Such devices can be effective in helping to overcome and treat sleep disorders; such as difficulty sleeping, snoring, and obstructive sleep apnea. The oral appliance 10, shown in FIG. 1, is configured to be positioned within a user's mouth and removably attached to a user's upper jaw and lower jaw. The oral appliance 10 may be defined to receive a user's teeth and/or jaw so as to fit comfortably inside the user's mouth. In the depicted embodiment, the oral appliance 10 comprises an adjustment assembly 15 which allows for positional adjustment of a user's lower jaw relative to the user's upper jaw. The adjustment of the lower jaw creates a larger airway for a user to breathe through, which typically aids in treating the user's sleep disorder. Additionally, the oral appliance 10 may be designed to remain in a user's mouth overnight and also be adjusted while remaining inside the user's mouth. Furthermore, the adjustment assembly 15 may be used for various oral appliances for mandibular advancement such as for intraoral distraction devices, as well as between any two anatomical members (e.g., upper and lower jaws) allowing for positional adjustment therebetween.

FIG. 1 shows an oral appliance 10 which has an anterior portion 12 that corresponds to the anterior or front of a user's jaw and a posterior portion 16 spaced away from the posterior portion that corresponds to the posterior or back of a user's jaw. In the depicted embodiment, the oral appliance 10 includes an upper housing 20 and a lower housing 30. The upper housing 20 includes two upper flanges 25 projecting outwardly therefrom (e.g., vertically or laterally with respect to the housing) or otherwise positioned proximate to the posterior portion 16. Also, the lower housing 30 includes two lower flanges 35 projecting outwardly therefrom (e.g., vertically or laterally with respect to the housing) or otherwise positioned proximate to the posterior portion 16, which correspond to the upper flanges 25 such that they are configured to engage each other to allow for positional advancement of the lower jaw relative to the upper jaw. In various embodiments, the upper and lower housing 20, 30 may have a single corresponding flange 25, 35 or may have two or more corresponding flanges 25, 35. In addition, the flanges 25, 35 may have various shapes configured to engage with one another, such as corresponding angled or curved surfaces. For example, the upper and lower housing 20, 30 and flanges 25, 35 could be similar to that disclosed by U.S. Patent No. 6,604,527 to Palmisano, which is hereby incorporated in its entirety herein. The upper housing 20 and/or lower housing 30 can be made of various materials, such as an acrylic material.

The oral appliance 10 further includes an adjustment assembly 15 contained within the lower housing 30, as shown in FIGS. 2 and 3. However, the adjustment assembly 15 may be contained in the upper housing 20 and connect to the upper flanges 25 if desired. In the depicted embodiment, the adjustment assembly 15 comprises an anterior adjustment mechanism 70, at least one posterior adjustment mechanism 50, and at least one rotatable wire 40 coupled to the anterior and posterior adjustment mechanisms. Each posterior adjustment mechanism 50 is coupled to a lower flange 35, and is configured to positionally adjust the lower flange 35 in relation to the lower housing 30, as described in further detail below. The rotatable wire 40 is configured to transfer the rotational forces from the anterior adjustment mechanism 70 to the posterior adjustment mechanism 50, so as to facilitate the positional adjustment of the lower flange 35. The adjustment assembly 15, shown in FIG. 1, allows for a user to interact directly with the anterior adjustment mechanism 70 to positionally adjust the lower flange 35. Thus, when a user wearing the oral appliance 10 bites down, the upper flanges 25 engage with the lower flanges 35 to reposition the user's lower jaw relative to the user's upper jaw.

In the depicted embodiment, the adjustment assembly 15 comprises two posterior adjustment mechanisms 50 and two corresponding rotatable wires 40 coupled to the anterior adjustment mechanism 70. The two posterior adjustment mechanisms 50 are positioned posteriorly within a user's mouth and on opposing sides of the jaw. Each wire 40 is guided from the anterior adjustment mechanism 70 to a respective posterior adjustment mechanism 50 via the housing. For instance, longitudinal openings may be defined in the housings 20, 30 for guiding the wires 40 while also allowing the wires to slide therein. Alternatively, the wires 40 could be coupled to the upper or lower housings 20, 30 using guides or include a covering for protecting the user. Although a pair of wires 40 are shown, a single wire could be employed and coupled to one or more posterior adjustment mechanisms 50. The one or more wires 40 may be various materials such as titanium or stainless steel.

In various embodiments, the anterior adjustment mechanism 70 is contained within, or otherwise coupled to, the upper or lower housing 20, 30 and is coupled to a corresponding upper or lower flange 25, 35. The anterior adjustment mechanism 70 allows for positional movement of the upper or lower flange 25, 35. FIG. 4 shows a detail view of the anterior adjustment mechanism 70. In the depicted embodiment, the anterior adjustment mechanism 70 comprises a key slot 72, a rotation device 75, and a cog or worm gear mechanism 80. The cog mechanism 80 includes a plurality of gear members engaging with one another and the rotatable wires 40 so as to transfer rotation with respect to one another. In one embodiment, the cog mechanism 80 includes a rotational device gear 84 and two wire gears 82. The rotational device gear 84, which is connected to the rotational device 75, engages with the two wire gears 82 such that rotation of the rotational device gear 84 causes the wire gears 82 to rotate, thereby rotating the wires 40. In various embodiments, different cog mechanisms could be employed to transfer rotation to the wires 40. The anterior adjustment mechanism 70 is configured such that when a key (not shown) engages with and rotates the key slot 72, the rotational device 75 also rotates, and interacts with the cog mechanism 80. The cog mechanism 80 facilitates rotation of the rotatable wires 40 connected to it. The rotatable wires 40 transfer the rotation to the posterior adjustment mechanism 50 to cause the desired adjustment of the flanges 35. Furthermore, the cog mechanism 80 allows the rotation of just one key and corresponding rotational device 75 to transfer rotation into two different rotatable wires 40. As such, in some embodiments, a single adjustment of the anterior adjustment mechanism 70 cause balanced adjustment of a plurality of posterior adjustment mechanisms 50.

In some embodiments of the present invention, the positional adjustment is facilitated by interaction of the anterior adjustment mechanism 70 with one or more posterior adjustment mechanisms 50. The posterior adjustment mechanism 50 may be coupled to or otherwise integrated within the upper or lower housing 20, 30. The posterior adjustment mechanisms 50 may include a stationary block 52 and a movable flange 35 or block 54. The stationary block 52 is configured to remain in place while the posterior adjustment mechanism 50 repositions the movable flange 35 or block 54 away from or closer to the stationary block 52. In various embodiments, the stationary block 52 could be coupled to the lower housing 30 (such as slidably engaged or fixedly attached thereto), while the movable block 54 could attach to the lower flange 35 or be integrally formed therewith.

As shown in FIGS. 5-7, the posterior adjustment mechanism 50 may include a cog mechanism, wherein the cog mechanism 60 may include a wire cog 62 and a screw cog 64 rotatably engaged with one another. The wire cog 62 is coupled to a rotatable wire 40 such that rotation of the rotatable wire 40 turns the wire cog 62, thereby rotating the screw cog 64. The cog mechanism 60 further includes a screw 55 coupled to the flange 35 and the stationary block 52. Thus, rotation of the screw cog 64 also turns the screw 55. Rotation of the screw 55 within or out of the flange 35 repositions the flange in the anterior or posterior direction, thus causing the lower flange 35 to be relocated in relation to the upper flange 25 (shown in FIG. 1). Thus, the position of the flange 35 is dependent upon the direction of rotation of the screw 55. The cog mechanism 60 is coupled to the stationary block 52 such that it remains stationary and does not move despite the forces acting on it. The posterior adjustment mechanism 50 may also contain one or more stabilization pins 58 extending between the flange 35 and the stationary block 52. The stabilization pin 58 provides stabilization when moving the flanges 35 and allows the posterior adjustment mechanism 50 to advance the flange 35 in a desired direction along the path of the stabilization pin 58. FIG. 7 shows a cross-sectional view of the posterior adjustment mechanism 50. In the depicted embodiment, the axes of rotation of the wire cog 62 and screw cog 64 are parallel to one another. In other various embodiments, the wire and screw cogs 62, 64 could be placed in other positions with respect to one another, as long as the wire cog 62 and screw cog 64 can interact to transfer rotational forces.

FIGS. 8-12 show another embodiment of an oral appliance 100 configured for mandibular advancement. In the depicted embodiment, the oral appliance 100 comprises an upper housing 120 and a lower housing 130. The upper housing 120 includes a pair of flanges 125 projecting outwardly therefrom and coupled to (or otherwise formed integrally therewith) an outer surface thereof. The lower housing 130 includes lower engagement members 135 (e.g., advancement blocks) coupled thereto and defining a surface configured to conform to and engage with the upper flanges 125. The engagement members 135 may be defined in the lower housing 130 so as to define a receiving surface for engaging the upper flanges 125.

In the depicted embodiment, an anterior adjustment mechanism 170 engages one or more rotatable wires 140, which causes one or more corresponding posterior adjustment mechanisms 150 to adjust the position of the lower engagement members 135 relative to the lower housing 130. When a user closes his or her mouth, the lower engagement members 135 engage with the upper flanges 125 to force the user's lower jaw to advance or retract depending on the current adjustments setting of the adjustment assembly. In particular, the upper flanges 125 extend downwardly with respect to the lower housing 130 such that the anterior surface of each flange interfaces with the posteriorly- facing slope of the engagement members 135. Thus, when the posterior adjustment mechanism 150 is activated, each engagement member pushes against a respective upper flange, affecting forward (anterior) movement of the lower housing (and mandible). The oral appliance 100, as shown in FIG. 11, may have a lower housing 130 that includes a sloped surface 138, which may facilitate placement of the lower housing in the user's mouth and interact more comfortably with a user's lower jaw. In reference to FIG. 8, the anterior adjustment mechanism 170 is accessible even when placed in the user's mouth. Thus, a user or physician can insert a key into the key slot 172 and positionally adjust the oral appliance 100 as needed. Moreover, although the flanges 125 project from the upper housing 120, it is understood that the flanges may be associated with the lower housing 130, while the upper housing may include corresponding engagement members 135 for receiving the flanges.

FIG. 13 shows another embodiment of an oral appliance 200 configured for mandibular advancement. In the depicted embodiment, the oral appliance 200 comprises a similar lower housing 230 to that described in conjunction with FIGS. 8- 12. However, the oral appliance 200 includes a simplified posterior adjustment mechanism 250. In particular, an anterior adjustment mechanism 270 engages one or more rotatable wires 240 coupled to a respective posterior adjustment mechanism 250, such as a screw. Thus, rotation of the wires 240 causes one or more corresponding posterior adjustment members 250 to engage the lower engagement members 235 (such as by turning the screw clockwise or counterclockwise) to thereby adjust the position of the lower engagement members relative to the lower housing 230. When a user closes his or her mouth, the lower engagement members 235 engage with the upper flanges 225 (similar to that shown in FIGS. 10-12) to force the user's lower jaw to advance or retract. Thus, the oral appliance 200 includes a simplified adjustment assembly for adjusting the relative position of the upper and lower jaws with respect to one another. As also noted above, although the adjustment assembly is described for the lower housing, the adjustment assembly may alternatively be configured for use with the upper housing.

One exemplary method of using the oral appliance 10, as described in the embodiments above, can also be used in a method for treating sleep disorders and is described below. In reference to FIG. 1, the oral appliance 10 is sized to properly fit inside a user's mouth. Then, the upper housing 20 of the oral appliance 10 is releasably attached to at least a portion of a user's upper jaw or teeth. Next, the lower housing 30 is releasably attached to at least a portion of the user's lower jaw or teeth. When the user closes his or her mouth, the upper and lower housing 20, 30 comprise upper and lower flanges 25, 35 which are configured to engage each other to facilitate mandibular advancement of the user's upper or lower jaw. In order to adjust the degree of mandibular advancement, a physician or the user can insert a key into the anterior adjustment mechanism 70 of the adjustment assembly 15. The key is rotated such that the anterior adjustment mechanism 70 can engage and rotate the wires 40 via the cog mechanism 80. The wires 40 may then engage one or more posterior adjustment mechanisms 50 via a respective cog mechanism 60 such that the lower flanges 35 are positionally adjusted in relation to its corresponding upper flange 25. Thus, by closing his or her mouth following the positional adjustment of the flanges 35, the user's lower jaw is positionally adjusted relative to the user's upper jaw.

FIGS. 14-14C show another embodiment of an oral appliance 400 configured for mandibular advancement. In the depicted embodiment, the oral appliance 400 comprises an upper housing 420 and a lower housing 430. The lower housing 430 includes a pair of flanges 435 projecting outwardly therefrom and coupled to (or otherwise formed integrally therewith) an outer surface thereof. The upper housing 420 includes upper engagement members 425 (e.g., advancement blocks) coupled thereto and defining a surface configured to conform to and engage with the lower flanges 435. The engagement members 425 may be defined in the upper housing 420 so as to define a receiving surface for engaging the lower flanges 435.

In the depicted embodiment, an anterior adjustment mechanism 470 engages one or more rotatable wires 440, which causes one or more corresponding posterior adjustment mechanisms 450 to adjust the position of the upper engagement members 425 relative to the upper housing 420. When a user closes his or her mouth, the upper engagement members 425 engage with the lower flanges 435 to force the user's lower jaw to advance or retract relative to the user's upper jaw. In particular, the lower flanges 435 extend upwardly toward the upper housing 420 such that the posterior surface of each lower flange interfaces with the anteriorly- facing slope of the engagement members 425. Thus, when the posterior adjustment mechanism 450 is activated, each engagement member 425 engages a respective lower flange 435, affecting relative (e.g., forward (anterior) or rearward (posterior)) movement of the lower housing (and mandible) with respect to the upper housing and upper jaw. The oral appliance 400, as shown in FIG. 14A, may have a lower housing 430 that includes a sloped surface 438 near the posterior end of the housing, which may facilitate placement of the lower housing in the user's mouth and interact more comfortably with a user's lower jaw.

As noted above, the posterior adjustment mechanism 450 may be configured to anteriorly-advance or posteriorly-retract the upper engagement members 425 with respect to the upper housing 420 and the stationary blocks 422 of the upper housing 420. With reference to FIGS. 14B and 14C, the upper engagement members 425 may comprise an adjustment tube 452 configured to engage the wire 440 and thereby adjust the upper engagement member 425 with respect to the stationary block 422. In some embodiments, the adjustment tube 452 may be internally threaded to compliment threading on at least a portion of the wire 440 such that rotation of the wire 440 causes displacement of the adjustment tube 452, and therefore the upper engagement member 425, along the threaded portion of the wire 440. In the depicted embodiment, anterior- advancement of the upper engagement member 425 may be guided along at least one stabilization pin 458. Further, in some embodiments, the wire 440 may be anchored into the stationary block 422 by a posterior wire anchor 446. The posterior wire anchor 446 facilitates rotation of the wire 440 and the connection of the wire 440 to the stationary block 422. In some embodiments, the upper engagement member 425 may also comprise an arm 455 that surrounds the adjustment tube 452 to maintain connection of the adjustment tube to the upper engagement member 425. In some embodiments, the adjustment tube 452 and/or arm 455 may be made of metal material and/or may be embedded substantially completely within the acrylic covering of the upper housing 420.

In reference to FIG. 14A, the anterior adjustment mechanism 470 is accessible even when placed in the user's mouth. Thus, a user or physician can insert a key into the key slot (not shown) and positionally adjust the oral appliance 400 as needed. Moreover, although the flanges 435 project from the lower housing 430, it is understood that the flanges may be associated with the upper housing 420, while the lower housing may include corresponding engagement members 425 for receiving the flanges.

FIGS. 15-18 show another embodiment of an oral appliance 500 configured for mandibular advancement. In the depicted embodiment, the oral appliance 500 comprises an upper housing 520 and a lower housing 530. The upper housing 520 includes a pair of flanges 525 projecting outwardly therefrom and coupled to (or otherwise formed integrally therewith) an outer surface thereof. The lower housing 530 includes lower engagement members 535 (e.g., advancement blocks) coupled thereto and defining a surface configured to engage with the upper flanges 525.

In the depicted embodiment, an anterior adjustment mechanism 570 engages one or more rotatable wires 540, which causes one or more corresponding posterior adjustment mechanisms 550 to adjust the position of the lower engagement members 535 relative to the lower housing 530. When a user closes his or her mouth, the lower engagement members 535 engage with the upper flanges 525 to force the user's lower jaw 584 to advance or retract relative to the user's upper jaw 582. In particular, the upper flanges 525 extend downwardly toward the lower housing 530 such that the anterior surface of each upper flange interfaces with the posteriorly-facing surface of the engagement member 535. Thus, when the posterior adjustment mechanism 550 is activated, each engagement member 535 engages a respective upper flange 525, affecting relative movement of the lower housing (and mandible) with respect to the upper housing.

The adjustment assembly of the oral appliance 500 may comprise an anterior adjustment mechanism 570 (see e.g., FIG. 15A), a wire 540 (see e.g., FIG. 15B), and a posterior adjustment mechanism 550 (see e.g., FIG. 15C). The anterior adjustment mechanism 570 may be a worm gear mechanism and comprise a key slot 572 for rotating the wire 540, such as with turning of a key engaged within the key slot. For example, the key slot 572 may include a worm gear that is configured to engage a corresponding worm coupled to each end of the wire 540 such that rotation of the key slot results in rotation of the wire. The wire 540 may be rotatably connected to the posterior adjustment mechanism 550 and at least a portion of the wire may be threaded. In the depicted embodiments, an adjustment block 555 is configured to displace along the wire 540 due to rotation of the wire 540. For example, the adjustment block 555 may be internally threaded to compliment the threaded portion of the wire 540 such that rotation of the wire 540 causes displacement (e.g., threading) of the adjustment block 555. In some embodiments, the adjustment block 555 may be coupled to the engagement member 535 such that displacement of the adjustment block 555 relative to the lower housing 530 corresponds to displacement of the engagement member 535 relative to the lower housing 530. As will be apparent to one of ordinary skill in the art in view of the disclosure, rotation of the wire 540 in the opposite direction will cause the adjustment block 555, and therefore the engagement member 535, to retract along the wire 540.

Therefore, with reference to FIGS. 17 and 18, the oral appliance 500 may be adjusted for mandibular advancement. In particular, a user may wear the upper housing 520 on their upper jaw 582 and the lower housing 530 on their lower jaw 584 such that a user may engage the upper flange 525 with the engagement member 535, such as is shown in FIG. 17, to advance the lower jaw a distance Dl . Next, the user may utilize the anterior adjustment mechanism 570 to adjust the relative position of the upper jaw and the lower jaw with respect to one another such as by advancing the lower jaw 584 a distance D2 relative to the upper jaw 582, as shown in FIG. 18.

FIGS. 19-2 OA show another embodiment of an oral appliance 600 configured for mandibular advancement. In the depicted embodiment, the oral appliance 600 comprises an upper housing 620 and a lower housing 630. The upper housing 620 includes a pair of flanges 625 projecting therefrom and coupled to (or otherwise formed integrally therewith) an outer surface thereof. The lower housing 630 includes lower engagement members 635 (e.g., advancement blocks) coupled thereto and defining a surface configured to engage with the upper flanges 625. The lower housing 630 also includes an anterior adjustment mechanism 670 connected to a wire 640 and configured to rotate the wire 640.

In the depicted embodiment, an anterior adjustment mechanism 670 engages one or more rotatable wires 640, which causes one or more corresponding posterior adjustment mechanisms 650 to adjust the position of the lower engagement members 635 relative to the lower housing 630. When a user closes his or her mouth, the lower engagement members 635 engage with the upper flanges 625 to force the user's lower jaw to advance or retract relative to the user's upper jaw. In the depicted embodiment, the lower housing 630 is positioned within both a horizontal plane P₆oi generally defined by the upper housing 620 and a horizontal plane P₆o2- In particular, the lower engagement members 635 are located within the horizontal plane P₆oi of the upper housing 620 such that the anterior surface of each upper flange 625 interfaces with the posteriorly- facing surface of the engagement member 635. Thus, when the posterior adjustment mechanism 650 is activated, each engagement member 635 engages a respective upper flange 625, affecting relative movement of the lower housing (and mandible) with respect to the upper housing. For example, as shown from FIGS. 19A and 20A, activation of the anterior adjustment mechanism 670 and, therefore, the posterior adjustment mechanism 650 causes the lower engagement members 635 to advance (shown in FIG. 20A). The advancement of the lower engagement members 635 will force the upper flanges 625 to move relative to the lower housing 630. In the depicted embodiment, as shown in FIG. 20A, when the lower engagement members 635 are in the advanced position, the front lip 621 of the upper housing 620 is spaced a distance Di away from the front lip 623 of the lower housing.

In some embodiments, the wire 640 may be positioned within the lower housing 630 to facilitate rotation and adjustment of the posterior adjustment mechanism. In the depicted embodiment, the wire 640 may be configured to facilitate rotation and adjustment of the posterior adjustment mechanism while extending from the horizontal plane P₆o2 of the lower housing 630 to the horizontal plane P₆oi generally defined by the upper housing 620. For example, the wire 640 may be curved partially upward to transfer rotation from one horizontal plane P₆o2 to another horizontal plane P₆₀₁.

FIG. 21 illustrates another embodiment of an oral appliance 700 configured for mandibular advancement. In the depicted embodiment, the oral appliance 700 comprises an upper housing 720 and a lower housing 730. The upper housing 720 includes a pair of flanges 725 projecting therefrom and coupled to (or otherwise formed integrally therewith) an outer surface thereof. The lower housing 730 includes lower engagement members 735 (e.g., advancement blocks) coupled thereto and defining a surface configured to engage with the upper flanges 725. The lower housing 730 also includes an anterior adjustment mechanism (not shown) connected to a wire 740 and configured to rotate the wire 740.

In the depicted embodiment, an anterior adjustment mechanism (not shown) engages one or more rotatable wires 740, which causes one or more corresponding posterior adjustment mechanisms 750 to adjust the position of the lower engagement members 735 relative to the lower housing 730. When a user closes his or her mouth, the lower engagement members 735 engage with the upper flanges 725 to force the user's lower jaw to advance or retract relative to the user's upper jaw. In particular, the lower engagement members 735 extend upwardly from the lower housing 730 such that at least a portion of the anterior surface of each upper flange 725 interfaces with the posteriorly-facing surface of the engagement member 735. Thus, when the posterior adjustment mechanism 750 is activated, each engagement member 735 engages a respective upper flange 725, affecting relative movement of the lower housing (and mandible) with respect to the upper housing. In some embodiments, the lower engagement member 735 may be aligned with a stationary block 738 such that displacement of the lower engagement member 735 may be guided by attachment to the stationary block 738. Moreover, in some embodiments, the lower engagement member 735 and the stationary block 738 may extend upwardly into the horizontal plane P₇oi generally defined by the upper housing 720.

FIG. 22 illustrates one embodiment of an oral appliance 300 including an upper housing 320 and a lower housing 330. The appliance 300 also includes a vertical height adjustment mechanism 350 engaged with the lower housing 320 for adjusting the degree of opening of the patient's mouth while sleeping. In particular, the adjustment mechanism 350 includes a screw 360 threaded into the lower housing 320 and engaging a block 365 for adjusting the relative size of an opening 370 defined between the upper and lower housings, which directly affects the amount that the mouth can be opened during sleep. The greater the vertical adjustment of the screw 360 outwardly and the smaller the opening 370, the less vertical opening of the mouth permitted. Because the upper and lower housing are in compression with respect to one another, the degree of vertical opening of the mouth during sleep can be adjusted using the vertical adjustment mechanism. As the mouth opens in some patients, the base of tongue obstructs; the vertical adjustment mechanism 350 allows the technician to control the degree of vertical mouth opening allowed during sleep in order to control this variable.

Embodiments of the present invention may provide several advantages. For example, an oral appliance with an adjustment assembly containing an anterior adjustment mechanism, as described above, allows for easier use of the oral appliance. In particular, the anterior adjustment mechanism is readily accessible such that the oral appliance may be adjusted while positioned inside a user's mouth. According to one embodiment of the present invention, the oral appliance utilizes an easily accessible and adjustable anterior adjustment mechanism which facilitates adjustment of one or more wires at the same time and/or rate, thus, simultaneously adjusting the position of the flanges or engagement members. Thus, adjustment of the anterior adjustment mechanism allows for uniform advancement of the jaw as the key is being turned.

Many modifications and other embodiments of the inventions set forth herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included herein. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

1. An oral appliance for treating sleep disorders, comprising:

an upper housing comprising an anterior portion and a posterior portion located remotely from the anterior portion, the upper housing configured to releasably attach to at least a portion of the upper jaw, wherein the upper housing comprises at least one upper flange proximate to the posterior portion;

a lower housing comprising an anterior portion and a posterior portion located remotely from the anterior portion, the lower housing configured to releasably attach to at least a portion of the lower jaw, wherein the lower housing comprises at least one lower flange proximate to the posterior portion, wherein the upper flange and lower flange are configured to engage one another to advance the lower jaw relative to the upper jaw; and

an anterior adjustment mechanism coupled to an anterior portion of the upper or lower housing and the at least one upper or lower flange such that adjustment of the anterior adjustment mechanism results in a positional adjustment of the at least one upper or lower flange so as to control the degree of advancement of the lower jaw relative to the upper jaw.

2. An oral appliance according to Claim 1, wherein the anterior adjustment mechanism is coupled to the at least one upper or lower flange with a rotatable wire guided by a respective upper or lower housing.

3. An oral appliance according to Claim 1, wherein the anterior adjustment mechanism comprises a rotatable cog mechanism coupled to the rotatable wire such that rotation of the wire engages the cog mechanism resulting in a positional adjustment of the at least one upper or lower flange.

4. An oral appliance according to Claim 1, wherein the anterior adjustment mechanism comprises a worm gear mechanism coupled to the rotatable wire such that rotation of the wire engages the worm gear mechanism resulting in a positional adjustment of the at least one upper or lower flange.

5. An oral appliance according to Claim 1, wherein the upper housing comprises a pair of upper flanges, and wherein the lower housing comprises a pair of lower flanges, and wherein each upper flange is configured to engage a corresponding lower flange.

6. An oral appliance according to Claim 1, further comprising at least one posterior adjustment mechanism coupled to the posterior portion of the upper or lower housing and the at least one upper or lower flange, wherein the posterior adjustment mechanism is configured to adjust the position of the at least one upper or lower flange.

7. An oral appliance according to Claim 6, wherein the anterior adjustment mechanism is coupled to the posterior adjustment mechanism such that adjustment of the anterior adjustment mechanism engages the posterior adjustment mechanism and results in a positional adjustment of the at least one upper or lower flange so as to control the degree of advancement of the lower jaw relative to the upper jaw.

8. An oral appliance according to Claim 6, further comprising a plurality of posterior adjustment mechanisms and a plurality of upper and lower flanges, wherein each posterior adjustment mechanism is coupled to a respective upper or lower flange.

9. An oral appliance according to Claim 8, wherein the plurality of posterior adjustment mechanisms are coupled to either the upper or lower housing, and wherein the anterior adjustment mechanism is configured to adjust a corresponding plurality of upper or lower flanges simultaneously.

10. An oral appliance according to Claim 9, wherein the plurality of posterior adjustment mechanisms are coupled to the lower housing and corresponding lower flanges.

11. An oral appliance according to Claim 9, wherein the plurality of posterior adjustment mechanisms are coupled to the upper housing and corresponding upper flanges.

12. An oral appliance according to Claim 6, wherein the anterior adjustment mechanism is coupled to the at least one posterior adjustment mechanism with a rotatable wire.

13. An oral appliance according to Claim 12, wherein the at least one posterior adjustment mechanism comprises a rotatable cog mechanism coupled to the rotatable wire such that rotation of the wire engages the cog mechanism resulting in a positional adjustment of the at least one upper or lower flange.

14. An oral appliance according to Claim 12, where at least a portion of the rotatable wire is threaded for engagement with the at least one posterior adjustment mechanism.

15. An oral appliance according to Claim 14, wherein the upper or lower housing comprises a threaded portion configured to threadably engage the rotatable wire.

16. An oral appliance according to Claim 12, wherein the least one posterior adjustment mechanism comprises a screw coupled to the at least one upper or lower flange, and wherein the screw is configured to engage the at least one upper or lower flange and adjust the position thereof in response to rotation of the wire.

17. An oral appliance according to Claim 1, wherein the upper or lower housing comprise an acrylic material.

18. An oral appliance according to Claim 1 , wherein the upper flange and lower flange project outwardly from a respective posterior portion.

19. An adjustment assembly for use with an oral appliance, the assembly comprising: an anterior adjustment mechanism;

at least one posterior adjustment mechanism; and

at least one rotatable wire coupled to the anterior adjustment mechanism and the posterior adjustment mechanism,

wherein the anterior and posterior adjustment mechanisms are coupled to the upper and/or lower jaws such that rotation of the wire engages the posterior adjustment mechanism resulting in a positional adjustment of the upper and lower jaws with respect to one another.

20. The adjustment assembly according to Claim 19, wherein the at least one posterior adjustment mechanism comprises a screw.

21. The adjustment assembly according to Claim 19, wherein the anterior adjustment mechanism and the at least one posterior adjustment mechanism are coupled to a lower housing or an upper housing, and wherein the upper or lower housing is configured to releasably attach to at least a portion of the upper or lower jaw, respectively.

22. A method of treating sleep disorders comprising:

releasably attaching an upper housing comprising an anterior portion and a posterior portion located remotely from the anterior portion to at least a portion of the upper jaw, wherein the upper housing comprises at least one upper flange proximate to the posterior portion;

releasably attaching a lower housing comprising an anterior portion and a posterior portion located remotely from the anterior portion to at least a portion of the lower jaw, wherein the lower housing comprises at least one lower flange proximate to the posterior portion, wherein the upper flange and lower flange are configured to engage one another to advance the lower jaw relative to the upper jaw; and

adjusting an anterior adjustment mechanism coupled to an anterior portion of the upper or lower housing and the at least one upper or lower flange so as to adjust the position of the at least one upper or lower flange and control the degree of advancement of the lower jaw relative to the upper jaw.