Orthopedic device for the advancement of midfacial bone structures

Abstract

A dental facial orthopedic device comprising a brace and a bracket. The brace is configured to be fixed to a skull having a cranial fixation assembly. The bracket comprises a first bracket member and a second bracket member. The first bracket member comprises a proximal end secured by an adjuster to a receiving member of a clamp mounted on the brace. The second bracket member has a tail end hinged to the distal end of the first bracket member by a hinge joint and has an anterior member configured to be rotatably fixed to an anterior portion of the skull by a fastener. The first bracket member is rotatable relative to the receiving member for selective locking of the first bracket member at different angular positions relative to the second bracket member having the hinge joint. When the adjuster is actuated, displacement of the bracket relative to the brace occurs.

Description

Technology Field

[0001] The embodiments of the method and device described herein generally relate to a dental-facial orthopedic device configured to be fixed to the skull and midface of a user, and specifically to a device useful for advancing the midface and maxillary and mandibular structures through the application of anterior-posterior tension. Background Technology

[0002] Hypoplasia of the skull and maxilla can affect a person's respiratory capacity and induce obstructive sleep apnea (OSA); it is often treated surgically, involving the resection and advancement of the midfacial bones. The inability to discretely advance the maxilla and develop the skull base, damage to neurovascular structures, and the risk of recurrence due to the sudden application of large stretching loads to soft tissues are known in the art.

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[0007] delete The problem to be solved

[0008] Prior art of patent applications Nos. 20170312053, 20060029899, ​​and 20050244769 discloses a maxillary advancement device that uses elastics to apply tension, which may not apply sufficient force to separate the cranial sutures of an adult. Additionally, to pull the maxilla, such a device relies on applying opposing force to anterior facial structures such as the forehead and jaw, which may be adversely affected by this pressure. means of solving the problem

[0009] To address the limitations of existing techniques, reduce the risk of recurrence, and increase the advancement potential of the midface and other bone structures of the skull, a midface advancement method is needed that allows for multiple individual advancements applying minimal stretching loads to soft tissues at once without cutting the bone. This method must not rely on elastic bodies to transmit force, must not require a counter-force in the anterior aspect of the facial structures, and must apply a ubiquitous antero-posterior force across the entire skull.

[0010] The proposed device and method solve the above problem by slowly expanding the soft tissues through the gradual application of tension at regular intervals between the maxilla and the back of the head without using bone cutting. This device also mechanically advances the lower jaw during sleep and fixes it in a predetermined position, thereby preventing airway collapse in OSA patients while they wear the device.

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[0013] Various embodiments of the present invention are applicable to various applications. One embodiment of the present invention is configured to be used as a dental facial orthopedic device (orthodontic device). According to one feature of the present embodiment, a brace made of metal or other rigid or semi-rigid material and configured to have some flexibility is screw-secured to a posterior section of the skull, such as the occipital region or other suitable cranial region, through at least one fixing screw.

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[0016] The brace is contoured to fit the shape of the skull, and it wraps around the back of the skull and forms a ring-shaped loop around the skull that forms a complete circle in front of the mouth. At the mouth end of the brace, there is a slot for an adjustable center screw / first bracket member that can be retracted or advanced by turning a nut / adjuster. The adjustable center screw / first bracket member is the anterior part of an orthodontic bracket, which is "Y" shaped in one embodiment, and the two ends of the "Y" are connected inside the mouth by fasteners in several ways, two of which are described herein. In one way, the tooth support connection is formed by a removable (removable) oral appliance type fastener worn on the upper teeth or an orthodontic bracket type fastener installed on the upper molars, and is connected to a "Y" bracket with a rotational joint. In the second method, there is no removable oral appliance, and the "Y" bracket is connected by bone-anchored ball and socket type fasteners that are implanted (fixed) intra-orally into other suitable bone structures, such as the maxilla or zygoma (but not limited to these). Thus, turning the adjuster at the front end of the brace allows the first bracket member or the adjustable center screw, which forms part of the orthodontic bracket, to advance and be pulled forward against the displaced bone structure. Turning the nut generates a displacement force that is translated to the back of the skull, where the brace is attached by the aforementioned fixing screw.

[0017] The slot / receiving member is joined 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 match the desired direction of movement of the maxilla or bone structure advancement. The proximal end of the first bracket member is fitted into the receiving member of the clamp at a predetermined position.

[0018] The first and second bracket members are connected by a hinge joint on the outside of the user's mouth, ensuring that the first bracket member is angled at a point in the desired pulling direction without affecting the placement of the second bracket member relative to the user's mouth, thereby allowing the user to maintain a lip seal.

[0019] The anterior half / segment of the brace is configured to be positioned in front of the user's mouth and is equipped with hinges having rotational joints on both sides, allowing the anterior half of the brace to be moved in unison when adjusting the angle of the orthodontic bracket. The posterior segment of the brace is secured to the skull by a cranial fixation assembly having a screw end that is implanted into the skull. Each cranial fixation assembly has a base that is screwed onto the head of the screw end, and this base is configured to protrude from the skull. On the protruding end, there is a circular plate that serves as an attachment point for the brace, which wraps around the circumference of the user's skull. The plate can be adjusted to sit in contact with the user's skull, separating it from the skin to avoid pressure on the skin.

[0020] In the case of OSA patients, they may wish to fix their mandible forward while sleeping while wearing dental-facial orthopedic devices. Therefore, one part of the device consists of a removable rigid mouthpiece designed to be worn on the dental arch of the lower jaw and connected to an orthodontic bracket via a bolted rod, said bolt being rotatable to advance the rigid mouthpiece.

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[0023] When a user sleeps on their side, it may be necessary to divert the weight of the skull away from the brace. A cushioning pad or set thereof is designed to be placed between the brace and the user's skin; this cushion protrudes from the surface of the brace, so that when the user's face rests on the cushion while sleeping on their side, the weight of the skull bypasses the brace and rests directly on the sleeping surface, such as a mattress or pillow.

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[0025] Instead of using a support cushion during sleep, the brace can be designed in a different version consisting of a half-brace that wraps around the left or right side of the skull, ensuring that it does not come into contact with the sleeping surface on either side.

[0026] delete Brief explanation of the drawing

[0027] A better understanding of the embodiments of the present disclosure (including alternatives and / or variations thereof) can be obtained by referring to the detailed description of the embodiments together with the following drawings. FIGS. 1a through 1c, and FIGS. 2a and 2b respectively illustrate a perspective view, plan view, side view, front view, and rear view of a general structure of a dental-facial orthopedic device. FIGS. 2c and 2d respectively illustrate the anchoring of the inner end (135) of a double-arm and single-arm second bracket member (131) of an intraoral version of the bracket. FIGS. 3a through 3c and FIGS. 4a and 4b respectively illustrate a perspective view, plan view, side view, front view, and rear view of a full-brace and full-bracket type dental-facial orthopedic device. FIG. 3d illustrates a perspective view of a half-brace (102) and full-bracket (114) type of the device (100). FIG. 3e illustrates a perspective view of a half-brace (102) and half-bracket (114) type of device (100). FIG. 5a through 5e respectively show a perspective view, front view, rear view, side view, and top view of a skull fixation assembly (200). FIG. 6a through 6d show a side view, top view, and cross-sectional view of a skull fixation and plate assembly. FIG. 6e and FIG. 6f show a side view and top view of a plate (202). FIG. 7a through 7d respectively show a front view, side view, rear view, and perspective view of a plate assembly. FIG. 8a illustrates a perspective view of a bracket (114) having a clamp (116). FIG. 8b and 8c respectively show a top view and a side view of a dental orthodontic bracket (114) without a clamp (116). FIGS. 1d and FIGS. 1e illustrate a single-arm version of a bracket (114) used with a brace (102). FIGS. 8f and FIGS. 8g illustrate a front view and a top view, respectively, of another embodiment of the bracket (114). FIGS. 8h shows a first bracket member (122) and a second bracket member (131) locked into a hinge joint (113) at an angle different from that shown in FIGS. 8f.FIGS. 9a through 9d respectively show two side views, a cross-sectional view, and a perspective view of a ball and socket joint system (900) type of fastener. FIGS. 10a and 10b respectively show a side view and a top view of a tooth-borne type of fastener. FIGS. 11a through 11e respectively show a perspective view, a top view, a front view, a rear view, and a side view of a clamp (116). FIGS. 12a, 12b, 13a, and 13b respectively show three side views and a rear view of a device (100) having a cushioning pad (502). FIGS. 14a and 14c show a perspective view of a protective helmet (602); FIG. 14b shows this in another embodiment. FIG. 15a shows a perspective view of a half-brace type embodiment (1500) of the device (100). FIGS. 15b, FIGS. 15c, FIGS. 16a, and FIGS. 16b illustrate a top view, side view, front view, and rear view of an embodiment (1500) together with a skull (107). FIGS. 15d and FIGS. 15e illustrate a half brace type of an embodiment (1500). FIGS. 17a through 17c, FIGS. 18a, and FIGS. 18b respectively show a perspective view, a top view, a side view, a front view, and a rear view of a sleeping brace (702). FIGS. 19a through 19c show two side views and a top view of an accompanying mouthpiece / dental orthodontic device (1900). FIGS. 20a through 20d show perspective views of other embodiments of the device (100). FIGS. 21a through 21b show a perspective view, a top view, and a front view of a half-brace type embodiment (1500). FIGS. 21d through 21f show a perspective view, a top view, and a front view of a half-brace type embodiment (1500), respectively. FIG. 22a shows the anchoring (fixing) of the inner end (135) of a double arm second bracket member. FIG. 22b illustrates the anchoring of the inner end (135) of the second bracket member (131) of a single arm.FIGS. 23a and 23b illustrate a brace (102) comprising only a full-rear brace segment (105). FIGS. 23C and 23d illustrate a brace (102) comprising a half-rear brace segment (105). FIG. 23e illustrates a top view of a device (100) comprising two extraoral brackets (114). FIG. 23f illustrates a top view of a device (100) comprising a one-arm extraoral bracket (114). FIGS. 24a and 24c illustrate a bottom view of a device (100) having a full-rear brace segment (105). FIG. 24a illustrates a bottom view of a device (100) having a full-rear brace segment (105) in use with two one-arm extraoral brackets (114). FIG. 24b illustrates a device (100) having an extraoral bracket (114) in use A side view of the device (100) is illustrated. FIG. 24c illustrates a bottom view of the device (100) having a half-rear brace segment (105) in use with a single-arm extraoral bracket (114). FIG. 25a and FIG. 25b illustrate the bottom and side views, respectively, of the device (100). FIG. 26a illustrates the device (100) having a full-rear brace segment (105) coupled to two single-arm intraoral brackets (114). FIG. 26b illustrates a bottom view of the device (100) having a full-rear brace segment (105) coupled to two single-arm intraoral brackets (114) in use. FIG. 26c illustrates the device (100) having a half-rear brace segment (105) coupled to a single-arm intraoral bracket (114). FIG. 26d illustrates the device (100) having a half-rear brace segment (105) coupled to a single-arm intraoral bracket (114). A bottom view of the device (100) is shown. FIGS. 27a and FIGS. 27b show a bottom view and a side view, respectively, of the device (100) having an entire posterior brace segment (105) having an intraoral bracket (114) fixed to the lower teeth.FIGS. 27c and FIGS. 27d respectively show a bottom view and a side view of a device (100) having a full rear brace segment (105) having two single-arm intraoral brackets (114). Specific details for implementing the invention

[0028] Embodiments and features of the present invention are described herein; however, the disclosed embodiments are merely examples of the invention that may be embodied in various and alternative forms.

[0029] FIGS. 1a to 1c, FIGS. 2a, FIGS. 2b, FIGS. 3a to 3c, FIGS. 4a and FIGS. 4b illustrate the structure of a bone anchored orthopedic device (100) (hereinafter referred to as the device) according to a preferred embodiment of the present invention. The dental facial orthopedic device (100) comprises a brace (102) having one or more brackets (114) and reinforcing brackets (106) coupled to one or more mounting portions (129) of the brace with the help of one or more clamps (117). The brace (102) is fixed to the user's skull (107) through one or more fixing assemblies (200). The brace (102) is a rigid or semi-rigid structure that adjustably fixes other components of the device (100) to a desired position, as described below. The brace may include at least one front brace segment (104) and at least one rear brace segment (105) connected by a hinge to the front brace segment (104) by a rotational joint (115). The front brace segment (104) and the rear brace segment (105) may extend to both sides of the skull (107) as shown in FIG. 3a, or may extend only to one side of the skull (107) as shown in FIG. 3d and FIG. 3e. The bracket (114) may have different shapes and sizes depending on the application type. FIG. 3d illustrates the use of a single-arm type bracket (114), while FIG. 3e shows a double-arm type bracket (114). In some embodiments, at least one front brace segment (104) is removable / detachable from the rotational joint (115). For example, the brace (102) may include only one or more posterior brace segments (105) that extend to both sides of the skull (107) as shown in FIG. 23a or only to one side of the skull (107) as shown in FIG. 23c.The brace (102) is contoured to fit the shape of the skull, which, if the front brace segment (104) is used, wraps around the front circumference of the skull and forms a complete circle in front of the mouth. In a preferred embodiment, at least one rear brace segment (105) is configured to be rotatable about a first axis of rotation (139) and to extend at least partially across the front region (160) of the user's skull (e.g., over the face) when it is fixed to the rear section (109) of the skull (107). The brace (102) can be separated into components by rotational joints (115) on both sides that allow such components of the brace to be positioned at various angles. Adjustable reinforcing plates (152, 154) on the rotational joints (115) allow the gap between the front brace segment (104) and the rear brace segment (105) to be varied as needed. The brace (102) is subjected to various physical and anatomical forces and limitations.

[0030] Referring to FIGS. 5a through 5e, FIGS. 6a through 6f and FIGS. 7a through 7d, according to one embodiment, at least one fixing assembly (200) is designed to be screw-coupled to a user's skull (107) to secure a brace (102) to the skull. The fixing assembly (200) comprises a screw end (201) configured to be fastened to any section of the skull (107) (e.g., fixed to a rear section (109) as shown in FIG. 2b), an opposite free end (202) spaced apart from a selectable distance from a base (203), and a plate assembly (204) configured to rotatably couple the free end (202) to a rear brace segment (105). The screw end (201) is paired with the base (203) via an internal screw (205) as shown in FIG. 6e. The base (203) is connected to a rotatable plate / free end (202) which is secured in place by a second internal screw (206) that is tightened at the head (208). Slots (207A and 207B) allow the free end (202) to be adjustablely mounted to the base (203) in the desired direction. By using a base (203) of the desired length, the necessary gap can be obtained between the free end (202) protruding from the skull and the screw end (201). The fixed screw end (201) is screwed into a position optimized for the shape of the bone, skull thickness, and force alignment so that the plane of the screw thread is as close as possible perpendicular to the direction of the desired force application at the point of entry of the screw.

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[0032] The rotatable plate / free end (202) is rotatably placed within a metal bracket / pocket (701) formed by a plate assembly (204) consisting of two metal plates (201) as shown in FIG. 7c. The plate assembly (204) is mounted in turn on a rear brace section (105) as shown in FIG. 3a through 3c and FIG. 4a through 4b.

[0033] The free end (202) is a connection point between the user's skull and the brace (102), and this can be adjusted so that the plate rotates and the angle is adjusted to match the tangential angle of the skull at the point where the screw end (201) passes through.

[0034] The free end (202) is configured to function as a substitute surface between the brace (102) and the user's skin, so that since the brace (102) rests entirely on the free end (202), the brace does not need to touch the user's skin or apply any force to the skin.

[0035] Referring to FIGS. 1a through 1c, FIGS. 3a through 3c and FIGS. 8a through 8c, a dental orthodontic bracket (114) comprises a first bracket member (122), a second bracket member (131), and a locking hinge joint (113). The first bracket (122) has a proximal end (123) and an opposite distal end (124), and the second bracket member (131) comprises a front member (132) and a tail end (133). According to one feature of a preferred embodiment of the present invention, the inner end (135) of the front member (132) is configured to be rotatably attached to an anterior portion of the skull (e.g., either the left or right side of the user's maxilla, or both sides, or a suitable bone structure inside the mouth) with the help of a fastener. In one embodiment, the fastener is a ball and socket joint system (900) as shown in FIGS. 9a through 9d. The ball and socket joint system (900) type fastener comprises a fastener end (300) configured to be implanted into either the left or right side of the maxilla, or both sides or other suitable bone structures, and a socket (301) configured to rotatably receive a ball-type inner end (135) so that the position of the bracket (114) can be optimized relative to the user's mouth to maintain a closed mouth while the user wears the device. FIG. 2c illustrates an exemplary method of fixing the inner ends (135) of a pair of double-arm / dual-arm second bracket members (131) of an intraoral version of the bracket (114) to one of the anterior bone parts of the user's skull (160), such as an intraoral bone structure (166), by means of a ball and socket joint type fastener (900). FIG. 2d illustrates a similar fixation for a single-arm version of the second bracket member (131) in the intraoral cavity.The dental orthodontic bracket (114) may also be attached with a fastener of the type of tooth-supporting dental orthodontic appliance (1000) as illustrated in FIGS. 10a to 10b, FIGS. 25a to 25b, and FIGS. 27c to 27d. In this type of fastener, the dental orthodontic appliance (1000) comprises a removable rigid or flexible mouthpiece or dental orthodontic bracket (303) designed to be attached to the anterior portion of the skull (e.g., teeth of the upper jaw), and one or more linkages (305) configured to pivotally and / or adjustablely connect the dental orthodontic bracket (303) to the inner end (135) of the anterior member (132). The dimensions and shape of the dental orthodontic bracket (303) and the linkages (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 a linkage (305) to a dental orthodontic bracket (303) at one end, and the other end of the linkage (305) is rotatably connected to the inner end (135) of the anterior member (132) of the dental orthodontic bracket (114) with skin penetration as shown in FIGS. 25a to 25b, and to the inner end (135) of the anterior member (132) of the dental orthodontic bracket (114) as shown in FIGS. 27c to 27d. The dental orthodontic device (1000) attached to the extraoral bracket (114) may be fixed to the lower jaw / tooth line if necessary. A clamp (116) enables the bracket (114) to be mounted to the mounting portion (129) of the brace (102), as shown in FIGS. 1a to 1e, FIGS. 3a to 3e, and FIGS. 23e to 23f. Referring to FIGS. 1a to 1c and FIGS. 3a to 3e, the first bracket member (122) is attached to the mounting portion (129) of the front brace segment (104) by a clamp (116) at its proximal end (123).More specifically, the proximal end (123) is adjustablely fixed to the receiving member (117) of the clamp (116) by a regulator (127), and the clamp (116) is optionally mounted to any section of the mounting portion (129) with the help of the clamp body (128). The rotating receiving member (117) has an opening (141) into which the proximal end (123) of the first bracket member (122) is inserted. It also has a groove (118) into which the brace (102) is fitted and a screw opening (119) for tightening the clamp body (128) to the brace (102). Additionally, it has two openings (120) so that a screw can adjust the angle of the receiving member (117). Referring to FIGS. 8a through 8c and FIGS. 11a through 11e, the opening (141) is configured to freely receive the proximal end (123) having a thread therein so that when the adjuster (127) rotates in any direction, the proximal end (123) is pulled or pushed through the opening (141) to generate translational movement of the first bracket member (122). The distal end (124) connects the first bracket member (122) to the second bracket member (131) at its tail end (133) by means of a hinge joint (113). The hinge joint (113) is configured to allow the first bracket member (122) to rotate around the second rotation axis (140) while selectively locking the first bracket member (122) at various angles relative to the second bracket member (131). Thus, the rotation of the adjuster (127) pulls the bracket (114) through the opening (141), then applies a pulling force to the user's maxilla or other bone structure, and applies a counter-force to the back of the skull, which is considered a fixed point using the brace (102).The first bracket member (122) at the end of the bracket (114) located outside the user's mouth can rotate independently in several directions, including the up-and-down direction, around the second rotation axis (140), as shown in FIGS. 1a to 1c, by unlocking the hinge and rotating the front half of the brace (104) at the rotation joint (115) of the brace, and by adjusting the pulling angle of the maxilla and other facial bones without interfering with the position of the inner part of the second bracket member (131) of the bracket (114) and the user's mouth, which may have been predetermined by setting the angle of the ball and socket joint (900) or the rotation joint around the longitudinal axis (901) shown in FIGS. 9a and 9b. Referring to FIGS. 1a to 1c, the receiving member (117) of the clamp (116) has a rotation center around the third rotation axis (145). The axis of rotation of the brace (139) is offset from the axis of rotation of the bracket (140) because, as the bracket (114) advances relative to the fixed brace (104), their lengths change and the distance of the bracket (114) changes. Therefore, the rotation of the brace (104) in harmony with the bracket (114) brings about a third axis of rotation (145) when the bracket (114) is rotatably held to the brace (104); this movement can occur by rotating the clamp (116) around the axis (145) while the bracket (114) is fixed to the brace (104). The bracket (114) can also be adjusted from left to right and can be divided into two or more individual brackets so that one side or part of the user's maxilla or the appropriate bone structure can be pulled independently from the other part.When more than one bracket (114) is used, each bracket (114) is designed to be independently connected to the front brace segment (104) through its own clamp (116), and each is secured to the front of its receiving member (117) with its own adjuster (127). Whether the front member (132) of the second bracket member (131) has a pair of arms (e.g., a "Y" shape extending from the tail end (133) as shown in FIGS. 8a to 8c) or only one arm (e.g., as shown in FIGS. 8d to 8f), in either case, the front member (132) is dimensioned to be fitted inside the user's mouth in the case of the intraoral version of the bracket (114) as shown in FIGS. 1a to 1d and FIGS. 2a to 2d, or to be fitted at least partially outside the mouth across the anterior portion (160) of the skull, penetrating the user's skin at the opening (2402) as shown in FIG. 24b, for example, and approaching a fixation point as shown in FIGS. 20a to 20d, FIGS. 21a to 21e, FIGS. 22a to 22b and FIGS. 24a to 24c. FIGS. 22a and 22b illustrate how the anterior member(s) (132) of the single-arm and double-arm versions of the extraoral second bracket member (131) are fixed to an anterior skull portion (e.g., bone structure of the maxilla, zygoma, or temporal bone) by means of ball and socket joint type fasteners (900), as shown in FIGS. 20a to 20d, when the bracket (114) is mounted to the anterior brace segment (104). FIGS. 24a to 24c illustrate the fixation of the extraoral bracket (114) to an anterior skull portion (160), such as the bone structure (166) of the upper jaw, when the bracket (114) is mounted directly to the mounting portion (129) of the full or half posterior brace segment (105).The term “anterior part / region (160)” is used herein to refer to any part of the frontal lobe and middle part of the skull, including the upper and lower teeth / jaws of the skull, cheekbones, sphenoid bones, frontal bones, parietal bones, and temporal bones. In another embodiment, as illustrated in FIGS. 26a through 26d and FIGS. 27a through 27d, the second bracket member (131) further comprises one or more couplers (2602) disposed between the tail end (133) and the anterior member (132). The one or more couplers (2602) are configured to enable selective locking engagement of the anterior member (132) in an adjustable relationship with respect to the tail end (133). For example, the anterior member (132) may be adjusted or twisted / rotated and locked by an engaging screw (2604) that engages at different positions relative to the tail end (133) depending on the requirements. In some embodiments, as illustrated in FIGS. 26a and 26b, the anterior member (132) may further include a bridging element (2606) that firmly joins both brackets (114) across the anterior portion (160) of the skull (107). FIG. 26b illustrates a posterior segment brace (105) secured to the skull (107) with the help of a ball and socket joint type fastener (900), and a double bracket (114) secured into the oral cavity to the anterior portion (160), such as the bone structure (166) of the upper jaw. FIG. 26d shows a similar fixation for a device (100) having a half posterior brace segment (105) having a single intraoral bracket (114). The device (100) further includes an accompanying mouthpiece (1900) as shown in FIG. 19a through 19c, which is another form of fastener designed to be temporarily worn on an anterior bone structure of the skull (e.g., teeth of the lower jaw).The above-mentioned accompanying mouthpiece type fastener (1900) comprises a dental orthodontic bracket (801) configured to be detachably fitted over an anterior bone structure (in this example, the teeth of the lower jaw), a linkage having a first elongated member (802) connected to the dental orthodontic bracket (801) at one end, a sleeve (803) disposed at the other end of the first elongated member (802), and a second elongated member (804) configured to be received through a thread (805) by the sleeve (803). A bolt (806) is placed on the thread (805) and can be rotated to advance the mouthpiece (801) in a forward direction, thereby advancing the mandible to open the user's airway. A compression spring (807) is mounted on the second elongated member (804) between a bolt head (806) and a sleeve (803) positioned on the dental orthodontic bracket (801) facing the side of the second elongated member (804) in a manner that causes the second elongated member (804) to be deflected toward the dental orthodontic bracket (801). As illustrated in FIGS. 19a, 19b, 27a and 27b, the distal end (808) of the second elongated member (804) is coupled to the inner end (135) of the front 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, and keeps the user's airway open for the purpose of fixing the lower jaw in an forward position relative to both the brace (102) and the user's airway.FIGS. 15a to 15c, FIGS. 16a to 16b, FIGS. 17a to 17c and FIGS. 18a to 18b illustrate an embodiment (1500) of a device (100) in which a brace (201) can be divided into left or right halves in such a way that the anterior brace extends only partially across both the anterior and posterior regions / parts of the user's skull, sufficient to be fixed to the posterior section (109) of the user's skull (107). This embodiment of the device (100) allows the user to wear one half of the device on one half of their skull while sleeping on the other side. The half portion (702) of the brace configured to be worn during sleep may have a removable structural reinforcement (703) that can be attached thereto, so that it may have the same rigidity and structural integrity as a brace that is not divided into right or left halves. Referring to FIGS. 12a to 12b and FIGS. 13a to 13b, in another embodiment, the rear brace segment (105) and the skull fixation assembly (200), in particular the base (203), are configured to provide space between the user's rear brace segment (105) and the skull (107) to accommodate one or more cushion pads (502) configured to be placed between the brace (102) and the user's skin to transfer the weight of the user's skull from the brace (102) to the cushion during sleep. FIGS. 12a and FIGS. 12b show a cushion pad (502) inserted under the brace (102) in a side view and a rear view, respectively. In some embodiments, the brace (102), bracket (114), and clamp (116) are configured to accommodate a safety helmet (602) as shown in FIG. 14c and are worn across at least a portion of the brace (102) as shown in FIGS. 14a through 14c. FIG. 14a shows the helmet (602) mounted on the device (100) when the user wears it.FIG. 14b illustrates the device (100) with another embodiment of the helmet (602) when the device (100) is not worn by a user. According to a preferred embodiment of the invention, due to the rotation of the adjustable center screw (127), the dental orthodontic bracket (114) is displaced relative to the brace (102), and as a result, a first force (148) is generated in a first direction on the bone structure to which the bracket (114) is fixed via a fastener, as shown in FIG. 1b. This generates a second force (150) in a second direction opposite to the first direction, which is transmitted to the cranial fixation assembly (200) via the brace (102). When the displacement force is applied gradually at regular intervals, expansion and osteoogenesis are induced in the cranial suture.

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[0044] The device disclosed herein may be implemented in other specific forms without departing from its essential characteristics. The described embodiments are exemplary in all respects and are not restrictive. Accordingly, the scope of the invention is defined by the appended claims, not by the foregoing description. All modifications within the scope of the meaning and equivalence of the claims are to be accommodated within that scope.

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[0050] Different features and structures of various embodiments may be combined or substituted with one another to the extent not already described. The fact that a feature is not illustrated in all embodiments does not mean that it cannot be illustrated, but is done for the sake of brevity of description. Accordingly, various features of different embodiments may be mixed and matched to form new embodiments, regardless of whether new embodiments are explicitly described. All combinations or substitutions of features described herein are included by this disclosure.

Claims

Claim 1 A brace configured to be fixed to a user's skull by means of one or more skull fixation assemblies; and at least one bracket, wherein the at least one bracket is a first bracket member having a proximal end and a distal end, wherein the proximal end is adjustablely fixed by a regulator to a receiving member of a clamp having a clamp body optionally mounted on any section of the mounting portion of the brace; A dental facial orthopedic device comprising: a second bracket member having a tail end hingedly connected to the distal end of the first bracket member by a hinge joint and an inner end configured to be rotatably fixed to the anterior part of the user’s skull by at least one fastener, wherein the first bracket member comprises at least one bracket including a second bracket member configured to be rotatably centered on the receiving member for selective locking of the first bracket member at a plurality of angular positions relative to the second bracket member by the hinge joint; wherein, at any one of the plurality of angular positions of the first bracket member, the operation of the adjuster causes displacement of the bracket relative to the brace, thereby applying a first force to the anterior part of the skull in a first direction through the at least one fastener and applying a second force to the skull in a second direction opposite to the first force through the one or more skull fixing assemblies. Claim 2 A dental facial orthopedic device according to claim 1, wherein the brace comprises at least one anterior brace segment and at least one posterior brace segment hinge-connected to the at least one anterior brace segment by a rotational joint, and the at least one anterior brace segment is configured to extend at least partially over the anterior portion of the skull when the at least one posterior brace segment is fixed to the skull. Claim 3 A dental facial orthopedic device according to paragraph 2, characterized in that the mounting portion is disposed on the at least one anterior brace segment or the at least one posterior brace segment. Claim 4 A dental facial orthopedic device according to claim 1, wherein the second bracket member further comprises a coupler between the tail end and the front member, and the coupler is configured to enable selective locking coupling of the front member in an adjustable relationship with respect to the tail end. Claim 5 A dental facial orthopedic device according to claim 1, wherein the front member of the second bracket member is a single arm or a pair of arms with dimensions specified for fixing the inner end to the front part in the oral cavity or outside the oral cavity. Claim 6 A dental facial orthopedic device according to claim 1, characterized in that 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. Claim 7 A dental facial orthopedic device according to claim 1, wherein the at least one fastener comprises a dental orthodontic bracket configured to be detachably coupled to the anterior portion of the user’s skull and a linkage configured to pivotally and / or adjustably connect the dental orthodontic bracket to the inner end of the anterior member, and wherein the anterior portion of the skull is the patient’s teeth or dental arch. Claim 8 A dental facial orthopedic device according to claim 1, wherein each of the one or more skull fixation assemblies comprises a screw end configured to be fastened to the skull, an opposite free end spaced apart from a base by a selectable distance, and a plate assembly configured to rotatably connect the free end to the brace, and wherein the free end is configured to be adjustablely mounted to the base in a desired direction. Claim 9 A brace comprising at least one anterior brace segment and at least one posterior brace segment hinged to said anterior brace segment by a rotational joint, wherein the at least one posterior brace segment is configured to be fixed to said user’s skull by one or more cranial fixation assemblies such that said at least one anterior brace segment extends at least partially across anterior region of said user’s skull; and at least one bracket, wherein the at least one bracket has a proximal end and a distal end, and the proximal end is adjustablely fixed by a regulator to a receiving member of a clamp having a clamp body that is optionally mounted to any section of the mounting portion of said at least one anterior brace segment; A second bracket member comprising a front member having a tail end hingedly connected to the distal end of the first bracket member by a hinge joint and an inner end configured to be rotatably attached to the anterior portion of the user's skull by at least one fastener, wherein the at least one front brace segment is configured to be rotatably about a first rotation axis passing through the rotation joint for selective locking of the first bracket member at a first plurality of angular positions relative to the second bracket member by the hinge joint;A dental facial orthopedic device comprising at least one bracket including, wherein the operation of the adjuster at any one of the plurality of angular positions of the first bracket member causes displacement of the bracket relative to the brace, thereby applying a first force to the anterior portion of the skull in a first direction through the at least one fastener, and applying a second force to the skull in a second direction opposite to the first force through one or more skull fixation assemblies. Claim 10 A dental facial orthopedic device according to claim 9, characterized in that the receiving member is configured to be swivelable about the clamp body around a third rotation axis substantially parallel to the second rotation axis in order to selectively lock the receiving member at a second plurality of angle positions corresponding to the first plurality of angle positions of the first bracket member. Claim 11 A dental facial orthopedic device according to claim 9, wherein the front member of the second bracket member is a single arm or a pair of arms with dimensions specified for fixing the inner end to the front part in the oral cavity or outside the oral cavity. Claim 12 A dental facial orthopedic device according to 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. Claim 13 A dental facial orthopedic device according to claim 9, wherein the at least one fastener comprises a dental orthodontic bracket configured to be detachably coupled to the anterior portion of the user’s skull and a linkage configured to pivotally and / or adjustably connect the dental orthodontic bracket to the inner end of the anterior member, and wherein the anterior portion of the skull is the patient’s teeth or dental arch. Claim 14 A dental facial orthopedic device according to claim 9, wherein each of the one or more skull fixation assemblies comprises a screw end configured to be fastened to the skull, an opposite free end spaced apart from a base by a selectable distance, and a plate assembly configured to rotatably connect the free end to the at least one posterior brace segment, wherein the free end is configured to be adjustablely mounted to the base in a desired direction. Claim 15 delete Claim 16 delete Claim 17 delete Claim 18 delete Claim 19 delete Claim 20 delete Claim 21 delete Claim 22 A dental facial orthopedic device according to claim 1, wherein the second bracket member further comprises a coupler between the tail end and the front member, and the coupler is configured to enable selective locking coupling of the front member in an adjustable relationship with respect to the tail end. Claim 23 delete Claim 24 delete Claim 25 delete Claim 26 delete Claim 27 delete Claim 28 delete Claim 29 delete Claim 30 delete Claim 31 delete Claim 32 delete Claim 33 delete

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