Orthopedic device for advancing mid-facial bony structures

Abstract

The subject matter disclosed herein comprises a dentofacial orthopedic device configured to allow a user to advance the midface relative to the skull, gradually opening the airway to improve breathing and facial structure. The device includes a brace configured to wrap around the user's skull and be secured to the skull with a screw designed to screw into the skull. An orthodontic "Y" bracket connects the brace to bony structures in the midface, such as the maxilla, via a ball-and-socket joint implanted inside the mouth or via a tooth-bearing connection to a removable appliance designed to fit around the maxillary teeth. The "Y" bracket connects to the brace via a rotating slot attached to the brace into which the tail end of the "Y" bracket is inserted. The tail end is threaded, and a bolt is connected to the threads at the front end of the slot. The user rotates the bolt along the threads on the tail end of the "Y" bracket and pulls it through the slot, pulling the midface forward or in a desired direction, causing separation between the skull's sutures under tension and creating bone at the sutures. The "Y" brackets can be adjusted to multiple angles, including up and down, to achieve the desired midface retraction. The device may also include a mouthpiece for the teeth in the lower arch, secured to the "Y" brackets via a second rod, which may be spring-loaded, that slides through a threaded sleeve that can be advanced using a bolt, distributing the load to the braces, advancing the mandible and keeping the user's airway open during sleep. [Other] The drawings only contain drawing numbers in Arabic numerals, and no translation is required, so no translation of the drawings will be submitted.

Description

Technical field of devices and methods

[0001] The method and device embodiments described herein generally relate to dental orthopedic devices configured to be anchored to a user's skull and midface, which are particularly useful for advancing midface and maxillofacial structures through the application of anterior-posterior tension.

[0002] Underdevelopment of the skull and upper facial bones can affect a person's ability to breathe, leading to obstructive sleep apnea (OSA), and is often treated surgically, whereby the central jaw is resected and advanced. The risk of recurrence due to the imposition of large stretch loads on the soft tissues all at once, damage to neurovascular structures, and the inability to discretely advance the maxilla to develop the skull base are known in the art.

[0003] Prior art patent applications 20170312053, 20060029899, ​​and 20050244769 describe maxillary advancement devices that use elastics to apply tension, but may not be able to apply sufficient force to separate the cranial sutures in adults, and to retract the maxilla, these devices rely on applying a counter force against anterior facial structures, such as the forehead and chin, which may be adversely affected by such pressure. Summary of the Invention

[0004] To address the limitations of existing techniques, there is a need for a midface advancement method that does not involve bone cutting and allows for multiple discrete advancements that simultaneously impose minimal extension loads on the soft tissues to reduce the risk of recurrence and increase the possibility of advancement of the midface or other bony structures of the skull. The method should not rely on elastics to deliver force, should not require a reaction force against the anterior facial structures, and should apply a ubiquitous anterior-posterior force across the entire skull.

[0005] The proposed device and method addresses this by applying gradual tension at regular intervals between the occipital region and the maxilla, slowly expanding the soft tissue without the use of bone cutting.

[0006] The device also allows the mandible to be mechanically advanced and held in place during sleep to prevent airway collapse in OSA patients while wearing the appliance.

[0007] Various embodiments of the present subject matter are applicable to a variety of uses. One embodiment of the present subject matter is configured for use as a dentofacial orthopedic device. According to one feature of this embodiment, a brace made of metal or another rigid or semi-rigid material, which may be configured to have some flexibility, is screwed into the back of the skull, such as the occiput, or another suitable skull region via at least one fixation screw.

[0008] The brace is contoured to the shape of the skull, wrapping around the back of the skull and forming a ring-like loop around the skull that terminates in a complete circle at the front of the mouth. The oral end of the brace has a slot for an adjustable central screw / first bracket member that can be retracted or advanced by turning a nut / adjuster. In one embodiment, the adjustable central screw / first bracket member is a "Y"-shaped anterior portion of an orthodontic bracket, two of which are connected in the mouth by fasteners at the two ends of the "Y" via multiple methods described herein. In one method, the tooth-bearing connection is made using either removable oral appliance-type fasteners attached to the maxillary teeth or orthodontic bracket-type fasteners placed on the maxillary molars and connected to the "Y" bracket with a swivel joint. In a second method, there is no removable oral appliance, and the "Y" bracket is connected to a bone-anchored ball-and-socket-type fastener implanted in the appropriate bony structure in the oral cavity (e.g., but not limited to, the maxilla or cheekbone). Thus, by turning the adjuster at the front end of the brace, the adjustable central screw or first bracket member that forms part of the orthodontic bracket can be advanced, pulling it forward against the bone structure to be displaced. Turning the nut creates a displacement force that is transmitted to the back of the skull, to which the brace is attached by the aforementioned fixation screw.

[0009] A slot / receiving member is attached to the anterior portion of the brace via a clamp. The receiving member is provided to receive the proximal end of a first bracket member, which can be angled to accommodate a desired direction of forward movement of the maxilla or bony structure. The proximal end of the first bracket member is attached to the receiving member of the clamp in a predetermined position.

[0010] The first and second bracket members are connected by a hinge joint outside the user's mouth, ensuring that the first bracket member can be angled to point in the desired pulling direction without affecting the placement of the second bracket member relative to the user's mouth, thus allowing the user to maintain a lip seal.

[0011] The front half / segment of the brace is configured to sit in front of the user's mouth and is hinged at a rotational joint on each side so that when the angle of the orthodontic bracket is adjusted, the front half of the brace can move in unison.

[0012] The posterior segments of the brace are secured to the skull using skull fixation assemblies with threaded ends that are implanted into the skull. Each skull fixation assembly has an abutment that screws onto the head of the threaded end and is configured to protrude from the skull. The protruding end has a circular plate that is an attachment point for the brace that wraps around the user's skull. The plate is adjusted to be positioned tangentially to the user's skull and can be separated from the skin to avoid pressure on the skin.

[0013] A person suffering from OSA may desire to hold the mandible forward during sleep while wearing a dentofacial orthopedic appliance. Thus, part of the appliance consists of a removable rigid mouthpiece designed to fit over the mandibular dental arch and connected via rods bolted to orthodontic brackets, such bolts being able to rotate to advance the rigid mouthpiece.

[0014] It may be necessary to divert the weight of the skull away from the brace when the user is sleeping on their side. A cushion pad or set of cushion pads is designed to be placed between the brace and the user's skin, such that the cushion protrudes from the surface of the brace and rests directly on a sleep surface, such as a mattress or pillow, when the user is sleeping on their side, thereby diverting the weight of the skull away from the brace.

[0015] As an alternative to the use of a support cushion while sleeping, the brace can be designed in another version consisting of one half of the brace that wraps around either the left or right side of the skull (neither side comes into contact with the sleep surface). [Brief explanation of the drawings]

[0016] A better understanding of embodiments of the present disclosure (including alternatives and / or variations thereof) can be obtained by reference to the following detailed description of the embodiments in conjunction with the drawings, in which:

[0017] 1A-1C and 2A, 2B show perspective, top, side, front, and back views, respectively, of the general structure of a dentofacial orthopedic device.

[0018] 2C and 2D show the fixation of the inner end (135) of the second bracket member (131) of the dual-arm and single-arm intraoral versions of the bracket, respectively.

[0019] Figures 3A-3C and 4A and 4B show perspective, top, side, front, and rear views of a full-brace, full-bracket type dentofacial orthopedic device, respectively. Figure 3D illustrates a perspective view of a half-brace (102), full-bracket (114) type of device (100). Figure 3E illustrates a perspective view of a half-brace (102), half-bracket (114) type of device (100).

[0020] 5A to 5E show perspective, front, rear, side, and top views, respectively, of the skull fixation assembly (200).

[0021] Figures 6A to 6D show side, top and cross-sectional views of the skull fixation and plate assembly, while Figures 6E and 6F show side and top views of plate (202).

[0022] 7A-7D show front, side, rear, and perspective views of the plate assembly, respectively.

[0023] Figure 8A shows a perspective view of the bracket (114) with a clamp (116). Figures 8B and 8C show top and side views, respectively, of the orthodontic bracket (114) without the clamp (116). Figures 1D and 1E show a single-arm version of the bracket (114) for use with braces (102).

[0024] 8F and 8G show front and top views, respectively, of yet another embodiment of bracket (114).

[0025] FIG. 8H shows the first bracket member (122) and the second bracket member (131) locked by the hinge joint (113) at a different angle than that shown in FIG. 8F.

[0026] Figures 9A to 9D show two side views, a cross-sectional view and a perspective view, respectively, of a ball and socket joint system (900) type fastener.

[0027] 10A and 10B show side and top views, respectively, of a tooth-bearing type fastener.

[0028] 11A-11E show a perspective view, a top view, a front view, a back view, and a side view of clamp 116, respectively.

[0029] 12A, 12B, 13A and 13B show three side and rear views, respectively, of the device (100) with the cushioning pad (502).

[0030] Figures 14A and 14C illustrate perspective views of the protective helmet (602), and Figure 14B shows it in another embodiment.

[0031] Figure 15A shows a perspective view of a half-brace type embodiment 1500 of the device 100. Figures 15B, 15C, 16A, and 16B show top, side, front, and back views of the embodiment 1500 with the skull 107. Figures 15D and 15E show the half-brace type embodiment 1500.

[0032] 17A-17C, 18A, and 18B show perspective, top, side, front, and back views, respectively, of the sleep brace (702).

[0033] Figures 19A to 19C show two side views and a top view of the accompanying mouthpiece / orthodontic appliance (1900).

[0034] Figures 20A to 20D show perspective views of another embodiment of the device (100).

[0035] 21A-21B show perspective, top, and front views of a half-brace type embodiment (1500).

[0036] 21D-21F show a perspective view, a top view, and a front view, respectively, of a half-brace type embodiment (1500).

[0037] FIG. 22A shows the fastening of the inner end (135) of the second bracket member of the double arm.

[0038] FIG. 22B shows the fastening of the inner end (135) of the single-arm second bracket member (131).

[0039] Figures 23A and 23B show the brace (102) with only the full rear brace segment (105).

[0040] Figures 23C and 23D show the brace (102) with half rear brace segments (105).

[0041] FIG. 23E shows a top view of the device (100) with two extraoral brackets (114).

[0042] FIG. 23F shows a top view of the device (100) with a one-arm extraoral bracket (114).

[0043] Figures 24A and 24C show bottom views of the device (100) with a full rear brace segment (105).

[0044] FIG. 24A shows a bottom view of the device (100) with a full rear brace segment (105) with two one-arm extraoral brackets (114) in use.

[0045] FIG. 24B shows a side view of the device (100) with the extraoral bracket (114) in use.

[0046] FIG. 24C shows a bottom view of the device (100) with a half rear brace segment (105) with a one-arm extraoral bracket (114) in use.

[0047] 25A-25B illustrate bottom and side views, respectively, of device 100.

[0048] FIG. 26A shows a device (100) having a full rear brace segment (105) coupled to two one-arm intraoral brackets (114).

[0049] FIG. 26B shows a bottom view of the device (100) with the full rear brace segment (105) coupled to two one-arm intraoral brackets (114) in use.

[0050] FIG. 26C shows a device (100) having a half rear brace segment (105) coupled to a one-arm intraoral bracket (114).

[0051] FIG. 26D shows a bottom view of the device (100) having a half rear brace segment (105) coupled to a one-arm intraoral bracket (114).

[0052] Figures 27A and 27B show bottom and side views, respectively, of a device (100) having full rear brace segments (105) with intraoral brackets (114) secured to the lower teeth.

[0053] Figures 27C and 27D show bottom and side views, respectively, of a device (100) having a full rear brace segment (105) with two one-arm intraoral brackets (114).

[0054] Although embodiments and features of the present invention have been described herein, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various and alternative forms.

[0055] Figures 1A-1C, 2A, 2B, 3A-3C, 4A, and 4B show the structure of a bone-anchored orthopedic device (100), hereinafter referred to as device (100), according to a preferred embodiment of the present invention. The dentofacial orthopedic device (100) comprises a brace (102) having a reinforcing bracket (106) and one or more brackets (114) coupled to one or more mounting portions (129) of the brace with the aid of one or more clamps (117). The brace (102) is secured to the user's skull (107) via at least one fixation assembly (200). The brace (102) is a rigid or semi-rigid structure that adjustably holds the other components of the device (100) in a desired location, as described later in this specification. The brace may include at least one front brace segment (104) and at least one rear brace segment (105) hingedly connected to the front brace segment (104) by a rotation joint (115). The front brace segment (104) and rear brace segment (105) may span both sides of the skull (107) as shown in FIG. 3A, or may span only one side of the skull (107) as shown in FIGS. 3D and 3E. The bracket (114) may have different shapes and sizes depending on the type of application. FIG. 3D illustrates the use of a one-arm type bracket (114), while FIG. 3E illustrates a dual-arm type bracket (114). In some embodiments, at least one front brace segment (104) is removable / detachable at the rotation joint (115). For example, the brace (102) may include only one or more rear brace segments (105) that span both sides of the skull (107) as shown in Figure 23A, or only one side of the skull (107) as shown in Figure 23C. The brace (102) is contoured to the shape of the skull, and if a front brace segment (104) is used, it wraps around the front of the skull and terminates in a complete circle in front of the mouth.In a preferred embodiment, the at least one rear brace segment (105) is configured to extend at least partially over the anterior region (160) of the user's skull (e.g., over the face) when secured to the rear section (109) of the skull (107), and is rotatable about a first axis of rotation (139). The brace (102) is separated into components by rotating joints (115) on both sides, allowing the brace components to be positioned at various angles. Adjustable stiffening plates (152) and (154) on the rotating joints (115) allow the spacing between the front brace segment (104) and the rear brace segment (105) to be varied as needed. The brace (102) is subject to various physical and anatomical forces and constraints.

[0056] Referring to Figures 5A-5E, 6A-6F, and 7A-7D, according to one embodiment, at least one fixation assembly (200) is designed to be screwed into a user's skull (107) to secure the brace (102) to the skull. The fixation assembly (200) includes a threaded end (201) configured to fasten to any section of the skull (107) (e.g., secured to the posterior section (109) as shown in Figure 2B), an opposing free end (202) separated by a selectable distance by an abutment (203), and a plate assembly (204) configured to rotatably couple the free end (202) to the rear brace segment (105). The threaded end (201) is mated to the abutment (203) via an internal screw (205), as shown in Figure 6E. The abutment (203) is connected to a rotatable plate / free end (202) that is held in place by a second internal screw (206) that tightens at its head (208). Slots 207A and 207B allow the free end (202) to be adjustably mounted to the abutment (203) in a desired orientation. Abutments (203) of desired lengths can be used to obtain the required spacing between the threaded end (201) and the free end (202) that protrudes from the skull.

[0057] The locking screw end (201) is threaded in a position optimized for bone geometry, skull thickness, and force alignment so that the plane of the threads is as close as possible to perpendicular to the desired direction of force application at the screw entry point.

[0058] The rotatable plate / free end (202) is rotatably positioned within a metal bracket / pocket (701) defined by a plate assembly (204) comprising two metal plates, as shown in Figure 7C. The plate assembly (204) is, in turn, mounted to the rear brace segment (105), as shown in Figures 3A-3C and 4A-4B.

[0059] The free end (202) is the connection point between the user's skull and the brace (102) and is adjustable so that it can be rotated and angled to match the tangent angle of the skull at the piercing point of the threaded end (201).

[0060] The free end (202) is configured to act as a proxy surface between the brace (102) and the user's skin, such that the brace (102) never needs to touch the user's skin or exert any force against the skin, as the brace rests entirely on the free end (202).

[0061] Referring to Figures 1A-1C, 3A-3C, and 8A-8C, an orthodontic bracket (114) includes a first bracket member (122), a second bracket member (131), and a lockable hinge joint (113). The first bracket (122) has a proximal end (123) and an opposite distal end (124), and the second bracket member (131) includes an anterior member (132) and a caudal end (133). According to one feature of a preferred embodiment, the medial end (135) of the anterior member (132) is adapted to be rotatably attached to an anterior portion of the skull (e.g., to either or both of the left and right sides of the user's maxilla, or to appropriate bony structures within the mouth) with the aid of a fastener. In one embodiment, the fastener is a ball-and-socket system (900) as shown in Figures 9A-9D. The ball-and-socket joint system (900) type fastener includes a fastener end (300) configured to be embedded in either the left or right side of the maxilla, both sides, or other suitable bony structures, and a socket (301) configured to rotatably receive a ball-type inner end (135) to allow for an optimized positioning of the bracket (114) relative to the user's mouth, allowing the user to maintain a closed mouth while wearing the appliance. Figure 2C illustrates an exemplary method of securing the inner end (135) of a pair-arm / double-arm / dual-arm second bracket member (131) of an intraoral version of the bracket (114) to one of the anterior bony portions of the user's skull (160), such as an internal bony structure (166) of the mouth, using the ball-and-socket joint type fastener (900). Figure 2D illustrates a similar intraoral fixation of a single-arm version of the second bracket member (131).

[0062] The orthodontic bracket (114) may also be attached with a tooth-bearing orthodontic appliance (1000) type fastener, as shown in Figures 10A-10B, 25A-25B, and 27C-27D. In this type of fastener, the orthodontic appliance (1000) comprises a removable rigid or flexible mouthpiece or orthodontic bracket (303) designed to fit over the anterior portion of the skull (e.g., the teeth in the upper jaw) and one or more linkages (305) configured to pivotally and / or adjustably connect the orthodontic bracket (303) to the inner end (135) of the anterior member (132). The size and shape of the orthodontic bracket (303) and linkage (305) are optimized for the user's mouth so that the user can maintain a closed mouth while wearing the appliance. A rotary joint (304) connects the linkage (305) at one end to the orthodontic bracket (303), and the other end of the linkage (305) is rotatably connected to the inner end (135) of the anterior member (132) of the orthodontic bracket (114) outside the mouth via a skin piercing as shown in Figures 25A-25B, and inside the mouth as shown in Figures 27C-27D. The orthodontic appliance (1000) attached to the extraoral bracket (114) can also be secured to the jaw / tooth line if desired.

[0063] As shown in Figures 1A-1E, 3A-3E, and 23E-23F, a clamp (116) enables attachment of the bracket (114) to the mounting portion (129) of the brace (102). Referring to Figures 1A-1C and 3A-3E, a first bracket member (122) is attached at its proximal end (123) to the mounting portion (129) of the front brace segment (104) by a clamp (116). More specifically, the proximal end (123) is adjustably secured to the receiving member (117) of the clamp (116) by an adjuster (127), and the clamp (116) is selectively attached to any section of the mounting portion (129) with the aid of a clamp body (128). The rotating receiver member (117) has an opening (141) for inserting the proximal end (123) of the first bracket member (122). It also has a groove (118) for fitting the brace (102) and a screw opening (119) for tightening the clamp body (128) onto the brace (102). It also has two openings (120) for screws to adjust the angle of the receiver member (117).

[0064] 8A-8C and 11A-11E, the opening (141) is configured to freely receive the proximal end (123), having a thread thereon, such that when the adjuster (127) is rotated in either direction, the proximal end (123) is pulled or pushed through the opening (141, causing translational movement of the first bracket member (122). The distal end (124) connects the first bracket member (122) at its tail end (133) to the second bracket member (131) by a hinge joint (113). The hinge joint (113) is configured to allow rotation of the first bracket member (122) about the second axis of rotation (140) while selectively locking the first bracket member (122) at various angles relative to the second bracket member (131). Thus, rotation of adjuster (127) pulls bracket (114) through opening (141), which in turn uses brace (102) to apply a reaction force to the back of the skull, which is considered a fixed point, exerting a tension force against the user's upper jaw or other bony structures.

[0065] The first bracket member (122) at the end of the bracket (114) located outside the user's mouth can be independently rotated in multiple directions, including up and down, about a second axis of rotation (140) at a lockable hinge joint (113) located outside the mouth, as shown in Figures 1A to 1C, to adjust the angle of retraction of the maxilla and other facial bones by unlocking the hinge and rotating the front half of the brace (104) at the brace's rotation joint (115) without disturbing the inner portion, i.e., the second bracket member (131) of the bracket (114), and its position relative to the user's mouth, which can be predetermined by setting the angle of the ball-and-socket joint (900) or rotation joint about its longitudinal axis (901) shown in Figures 9A and 9B.

[0066] 1A-1C, the receiving member (117) of the clamp (116) has a center of rotation about a third axis of rotation (145). The axis of rotation of the brace (139) is offset from the axis of rotation of the bracket (140) due to their different lengths and the changing distance of the bracket (114) as it advances relative to the fixed brace (104). Thus, rotation of the brace (104) together with the bracket (114) provides the third axis of rotation (145), and rotation of the clamp (116) about its axis (145) while holding the bracket (114) to the brace (104) enables this movement if the bracket (114) remains rotatably held to the brace (104).

[0067] The brackets (114) may also be adjusted from left to right and may be split into two or more separate brackets so that one side or portion of the user's upper jaw or appropriate bone structure may be tensioned independently from another portion. When two or more brackets (114) are used, each bracket (114) is designed to be independently connected to the front brace segment (104) via its own clamp (116), and each bracket is held forward of its receiving member (117) using its own adjuster (127). Whether the anterior member (132) of the second bracket member (131) has a pair of arms (e.g., in a "Y" shape extending from the tail end (133), as shown in Figures 8A-8C) or only one arm (e.g., as shown in Figures 8D-8F), in either case, the anterior member (132) is sized to fit inside the user's mouth in the case of intraoral versions of the bracket (114) as shown in Figures 1A-1D, 2A-2D, or to fit outside the mouth at least partially over the anterior portion (160) of the skull, for example, to pierce the user's skin at openings (2402), as shown in Figure 24B, to access fixation points as shown in Figures 20A-20D, 21A-21E, 22A-22B, and 24A-24C.

[0068] Figures 22A and 22B further illustrate how the anterior member (132) of the single-arm and dual-arm versions of the extraoral second bracket member (131) can be configured to be secured to an anterior skull portion (e.g., maxilla, zygomatic, or temporal bone bony structures) using ball-and-socket joint-type fasteners (900) when the bracket (114) is attached to the front brace segment (104) as shown in Figures 20A to 20D. Figures 24A to 24C illustrate the fixation of a similar extraoral bracket (114) to an anterior skull portion (160), such as the maxilla bony structure (166), when the bracket (114) is attached directly to the mounting portion (129) of a full or half rear brace segment (105). The term "anterior portion / region (160)" is used herein to refer to any portion of the frontal and middle part of the skull, including the upper and lower teeth / jaw, cheekbones, sphenoid, frontal, parietal, and temporal bones of the skull.

[0069] In another embodiment, as shown in FIGS. 26A-26D and 27A-27D, the second bracket member (131) further comprises one or more connectors (2602) disposed between the caudal end (133) and the anterior member (132). The one or more connectors (2602) are configured to allow selective locking of the anterior member (132) in an adjustable relationship relative to the caudal end (133). For example, the anterior member (132) can be adjusted or twisted / rotated and locked as needed by engaging the screws (2604) at different positions relative to the caudal end (133). In some embodiments, as shown in FIGS. 26A-26B, the anterior member (132) may further comprise a bridging element (2606) that covers the anterior portion (160) of the skull (107) to rigidly connect both brackets (114).

[0070] Figure 26B shows a rear segment brace (105) secured to the skull (107) and a dual bracket (114) secured intraorally to an anterior portion (160), such as the maxillary bony structure (166), with the aid of a ball-and-socket joint type fastener (900). Figure 26D shows a similar fixation of the device (100) with a half rear brace segment (105) with one intraoral bracket (114).

[0071] The device (100) further includes an associated mouthpiece (1900), which is another form of fastener designed to be temporarily attached over an anterior bony structure of the skull (e.g., the teeth of the mandible), as shown in Figures 19A-19C. The associated mouthpiece-type fastener (1900) includes an orthodontic bracket (801) configured to removably fit over an anterior bony structure (in this example, the teeth of the mandible), and a linkage having an elongated first member (802) connected at one end to the orthodontic bracket (801), a sleeve (803) disposed at the other end of the first elongated member (802), and a second elongated member (804) configured to be received by the sleeve (803) via threads (805). A bolt (806) is seated on the threads (805) and can be turned to advance the mouthpiece (801) in a forward direction, thus advancing the mandible and opening the user's airway. A compression spring (807) is mounted on the second elongated member (804) between the sleeve (803) and a bolt head (806) located on the side of the second elongated member (804) facing the orthodontic bracket (801) so that the second elongated member (804) is biased toward the orthodontic bracket (801). As shown in Figures 19A, 19B, 27A, and 27B, the distal end (808) of the second elongated member (804) is coupled to the inner end (135) of the anterior member (132) through a socket (1908). The bolt head (806) can be rotated to advance the sleeve (803) forward, which advances the first elongated member (802) connected to the mouthpiece (801) forward, and thus advances the mouthpiece (801) forward, with the purpose of locking the lower jaw in a forward position relative to both the brace (102) and the user's airway, keeping the user's airway open.

[0072] Figures 15A-15C, 16A-16B, 17A-17C, and 18A-18B show an embodiment (1500) of device (100) in which brace (102) can be split into left or right halves in such a way that the front brace only partially extends over both the anterior and posterior regions / portions of the user's skull sufficiently to secure to the rear section (109) of the user's skull (107). This embodiment of device (100) allows a user to wear one half of the appliance on one half of their skull and sleep on the other side.

[0073] One side of the brace (702) configured to be worn during sleep can have a removable structural reinforcement (703) attached to it, allowing it to have the same stiffness and structural integrity as a brace that is not split into right or left halves.

[0074] 12A-12B and 13A-13B, in another embodiment, the rear brace segment (105) and skull fixation assembly (200), particularly the abutment (203), are adapted to accommodate one or more cushion pads (502) configured to be placed between the brace (102) and the user's skin to provide space between the rear brace segment (105) and the user's skull (107) and to deflect the weight of the user's skull away from the brace (102) and onto a cushion during sleep. Figures 12A and 12B show the cushion pads (502) inserted under the brace (102) from side and rear views, respectively.

[0075] In some embodiments, the brace (102), bracket (114), and clamp (116) are configured to accommodate a safety helmet (602), as shown in Figure 14C, fitted over at least a portion of the brace (102), as shown in Figures 14A-14C. Figure 14A shows the helmet (602) fitted onto the device (110). Figure 14B shows the device (100) when not being worn by a user, along with another embodiment of the helmet (602).

[0076] According to a preferred embodiment, rotation of the adjustable central screw (127) displaces the orthodontic bracket (114) relative to the brace (102), thereby generating a first force (148) in a first direction on the bony structure to which the bracket (114) is secured via fasteners, as shown in FIG. 1B. This generates a second force (150) in a second direction opposite the first direction, which is transmitted through the brace (102) to the skull fixation assembly (200). The gradual application of the displacement force at regular intervals causes expansion and bone formation at the skull sutures.

[0077] The devices disclosed herein may be embodied in other specific forms without departing from their essential characteristics. The described embodiments are intended in all respects to be illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

[0078] To the extent not already described, different features and structures of the various embodiments may be used in combination with or substituted for one another. The fact that a feature is not shown in all embodiments is not meant to be construed as meaning that it cannot be so shown, but is done for the sake of brevity. Thus, various features of different embodiments may be mixed and matched to form new embodiments, whether or not the new embodiments are explicitly described. All combinations or permutations of features described herein are covered by this disclosure.

Claims

1. 1. A dentofacial orthopedic device comprising: a brace configured to be secured to the occipital region of a user's skull using one or more skull fixation assemblies; and at least one bracket, The at least one bracket is: a first bracket member having a proximal end and a distal end, the proximal end being adjustably secured by an adjuster to a clamp receiving member having a clamp body selectively attached to any section of the mounting portion of the brace; and, a second bracket member having a caudal end hingedly connected to the distal end of the first bracket member by a hinge joint, and an anterior member having an inner end configured to be rotatably secured to an anterior portion of the user's skull by at least one fastener; Equipped with the first bracket member is rotatable about the receiving member to selectively lock the first bracket member relative to the second bracket member at a plurality of angular positions using the hinge joint; actuation of the adjuster at any of the plurality of angular positions of the first bracket member is configured to cause displacement of the bracket relative to the brace to exert a first force on the anterior portion of the skull through the at least one fastener in a first direction and a second force on the occipital portion of the skull through the one or more skull fixation assemblies in a second direction opposite to the first force. characterized in that Dentofacial orthopedic devices.

2. 10. The dentofacial orthopedic device of claim 1, the brace comprises at least one front brace segment and at least one rear brace segment hingedly connected to the at least one front brace segment by a rotational joint, the at least one front brace segment configured to extend at least partially over the anterior portion of the skull when the at least one rear brace segment is secured to the occipital portion of the skull. characterized in that 10. The dentofacial orthopedic device of claim 1.

3. The dentofacial orthopedic device of claim 2, wherein the mounting portion is disposed within the at least one front brace segment or the at least one rear brace segment.

4. the second bracket member further comprising a coupler between the tail end and the forward member, the coupler configured to permit selective locking engagement of the forward member in adjustable relation to the tail end. characterized in that 10. The dentofacial orthopedic device of claim 1.

5. 2. The dentofacial orthopedic device of claim 1, wherein the anterior member of the second bracket member is a single arm or a pair of arms dimensioned for intraorally or extraorally fixation to the anterior portion of the inner end.

6. 2. The dentofacial orthopedic device of claim 1, wherein the at least one fastener is a ball and socket system comprising a fastener end configured to be implantable in the anterior portion of the skull and a socket configured to rotatably receive the inner end of the anterior member.

7. 10. The dentofacial orthopedic device of claim 1, wherein the at least one fastener comprises: an orthodontic bracket configured to be removably attached over the anterior portion of the user's skull; and a linkage configured to pivotally and / or adjustably connect the orthodontic bracket to the inner end of the anterior member, wherein the anterior portion of the skull is a patient's teeth or dental arch. characterized in that 10. The dentofacial orthopedic device of claim 1.

8. 10. The dentofacial orthopedic device of claim 1, wherein each of the one or more skull fixation assemblies comprises a threaded end configured to be fastened to an occipital portion of the skull, an opposing free end spaced a selectable distance by an abutment, and a plate assembly configured to rotatably couple the free end to the brace, the free end configured to be adjustably attached to the abutment in a desired orientation. characterized in that 10. The dentofacial orthopedic device of claim 1.

9. 1. A dentofacial orthopedic device comprising: a brace having at least one front brace segment and at least one rear brace segment hingedly connected to the at least one front brace segment by a rotational joint, the at least one rear brace segment configured to be secured to an occipital region of the user's skull by one or more skull fixation assemblies such that the at least one front brace segment extends at least partially over an anterior region of the user's skull; and at least one bracket, The at least one bracket is: a first bracket member having a proximal end and a distal end, the proximal end being adjustably secured by an adjuster to a clamp receiving member having a clamp body selectively attached to any section of a mounting portion of the at least one front brace segment; and, a second bracket member having a caudal end hingedly connected to the distal end of the first bracket member by a hinge joint, and an anterior member having an inner end configured to be rotatably attached to an anterior portion of the user's skull by at least one fastener; Equipped with the at least one front brace segment is rotatable relative to the at least one rear brace segment about a first axis of rotation passing through the rotational joint; enabling rotation of the first bracket member about a second axis of rotation to selectively lock the first bracket member at a first plurality of angular positions relative to the second bracket member using the hinge joint; actuation of the adjuster at any of the plurality of angular positions of the first bracket member is configured to cause displacement of the bracket relative to the brace to exert a first force on the anterior portion of the skull through the at least one fastener in a first direction and a second force on the occipital portion of the skull through the one or more skull fixation assemblies in a second direction opposite to the first force. characterized in that Dentofacial orthopedic devices.

10. the receiving member is configured to be pivotable relative to the clamp body about a third axis of rotation substantially parallel to the second axis of rotation for selective locking of the receiving member at a second plurality of angular positions corresponding to the first plurality of angular positions of the first bracket member. characterized in that 10. The dentofacial orthopedic device of claim 9.

11. 10. The dentofacial orthopedic device of claim 9, wherein the anterior member of the second bracket member is a single arm or a pair of arms dimensioned for intraorally or extraorally fixation to the anterior portion of the inner end.

12. 10. The dentofacial orthopedic device of claim 9, wherein the at least one fastener is a ball and socket system comprising a fastener end configured to be implantable in the anterior portion of the skull and a socket configured to rotatably receive the inner end of the anterior member.

13. 10. The dentofacial orthopedic device of claim 9, wherein the at least one fastener comprises: an orthodontic bracket configured to be removably attached over the anterior portion of the user's skull; and a linkage configured to pivotally and / or adjustably connect the orthodontic bracket to the inner end of the anterior member, wherein the anterior portion of the skull is a patient's teeth or dental arch. characterized in that 10. The dentofacial orthopedic device of claim 9.

14. 10. The dentofacial orthopedic device of claim 9, wherein each of the one or more skull fixation assemblies comprises a threaded end configured to be fastened to an occipital portion of the skull, an opposing free end spaced a selectable distance by an abutment, and a plate assembly configured to rotatably couple the free end to the one or more rear brace segments, the free end configured to be adjustably attached to the abutment in a desired orientation. characterized in that 10. The dentofacial orthopedic device of claim 9.

15. the second bracket member further comprising a coupler between the tail end and the forward member, the coupler configured to permit selective locking engagement of the forward member in adjustable relation to the tail end. characterized in that 10. The dentofacial orthopedic device of claim 1.

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