Improved maxillary arch expander and retractor device

Abstract

A medical device and method are provided for dilating a patient's maxillary jaw by applying an intraoral generated force to the patient's maxillary jaw and / or applying an externally generated traction force to the patient's maxillary jaw. The medical device may implement a variety of configuration devices, including a separate bone anchoring device or a bone anchoring device in combination with a fixed aligner or an adjustable aligner.

Description

[0001] This application is a divisional application of the invention patent application named "Improved Maxillary Expander and Retractor Device", filed on November 24, 2018, and with application number 202210655273.4.

[0002] Continue Information

[0003] This application is related to and claims priority to the following applications: U.S. Provisional Application Serial Number 62 / 685,801 and Confirmation Number 5437 filed on 6 / 15 / 2018, U.S. Provisional Application Serial Number 62 / 590,363 and Confirmation Number 3619 filed on 11 / 24 / 2017, U.S. Provisional Application Serial Number 62 / 676,969 and Confirmation Number 1055 filed on 5 / 26 / 2018, U.S. Provisional Application Serial Number 62 / 699,264 and Confirmation Number 7667 filed on 7 / 17 / 2018, and U.S. Provisional Application Serial Number 16 / 115,564 and Confirmation Number 6177 filed on 8 / 29 / 2018; all of the above applications are incorporated herein by reference for all purposes. Background Art

[0004] Current maxillary fixed expanders (hereinafter referred to as "expanders" in the background section) are devices that can be used to treat patients with insufficient lateral and anterior-posterior development of the maxilla. In pediatric patients, maxillary expanders have been used to expand the maxillary dental arch to create space for the growth of permanent teeth, or to expand the maxilla so that the upper and lower teeth can better bite. In some cases, expansion can be used to treat airway stenosis. Some known maxillary expanders are constructed and expand the maxillary dental arch by connecting tooth (molar) retainers (i.e., bands) using an adjustable screw mechanism (see US5564920 Klapper). When the screw is rotated, a bidirectional force is applied to the teeth and jaws, which causes displacement of the teeth and the maxillary dental arch. After installation, the screw is rotated using a tool to adjust it. The screw is usually composed of two opposing halves, each of which has a threaded portion. The force generated by the expansion of the screw is transmitted to the molars covered with the bands through the arms of the device, and ultimately leads to the expansion of the maxillary dental arch and / or the growth of the mid-jaw suture. The expander is left in the mouth for an effective course of treatment, and the patient or the patient's caregiver uses the expander by rotating the screw a predetermined number of turns over a predetermined period of time, depending on the size of the expander screw, the patient's age, and the indication for treatment (e.g., 1 / 4 turn per week produces 0.25 mm of movement; 1 / 4-1 / 2 turn per day produces 0.25-0.50 mm of movement, etc.). After the desired expansion is achieved, a retention phase is performed, and the expander is left in place for 3-6 months to stabilize the effect, during which time the screw is fixed to prevent rotation. During the retention phase, the tooth / jaw surfaces stabilize in the new position, the mid-palatal suture recloses in the entire space, and the expander is then removed. The above-mentioned expanders increase the space in the mid-palatal suture only by the orthodontic forces applied to the teeth.

[0005] US9,351,810 (Moon) patent shows another known expander device. The Moon expander uses four micro-implants / temporary fixation devices to install a pair of bodies on the top of the hard palate on both sides of the raphe. Each pair of bodies of the Moon expander also includes a pair of extension arms and a pair of band devices similar to those used by Klapper above to fix the teeth. The Moon expander includes a stud screw located between the pair of bodies. When the stud screw on the Moon expander is rotated, the correction force is not only directly applied to the teeth, but also transmitted to the hard palate on both sides of the raphe through the micro-implants. Unlike the Klapper expander, since the correction force is also applied directly to the hard palate, the correction force acting on the teeth is reduced and the correction force acting on the jaw is increased. This reduced correction force means that the stress on the teeth / mandibular surface can be reduced. However, the Moon expander also has many disadvantages. By applying force directly to the hard palate, the micro-implants will be stressed and may break, and the bone structure in the area where the micro-implants are implanted may also be broken. Furthermore, although the Moon expander exerts less corrective force on the teeth, it still transmits corrective force to the teeth and causes tooth movement, which may be undesirable. For example, when treating lateral maxillary hypoplasia in skeletally mature patients, the force transmitted to the teeth may result in an undesirable alveolar effect, such as alveolar "bending", root resorption, and even a "scissor bite". In addition, the Moon expander is supported by only two micro-screws on each side of the mid-palatal suture, which is often insufficient and ineffective in producing the desired correction in skeletally mature individuals, which may result in the need for osteotomy after expansion. In the case of skeletally mature patients, implanting only two micro-screws on each side of the mid-palatal suture (a total of four) is not only ineffective in producing the desired correction expansion, but also results in increased stress on each micro-screw and the surrounding bone. This is evidenced by the fact that the Moon expander often needs to be unscrewed to the maximum when used in skeletally mature individuals, that is, 8-12 mm of expansion, just to open the mid-palatal suture and achieve 1-2 mm of correction expansion. This is an inefficient bony expansion and the lack of the ability to replace different sized expansion screws that connect the fixture has resulted in the need for at least two Moon expanders in many cases to achieve satisfactory bony expansion in a mature individual. The need to remove and install the expander multiple times results in multiple surgeries for the patient, higher costs and discomfort, and increased clinician effort. In addition, while Moon's device can be used to apply distraction to patients with underdeveloped anterior-posterior jaws, the device relies on the teeth for its stability, such that at least a portion of the distraction must be transferred to the teeth rather than applying all of the distraction to the bone structure.

[0006] Therefore, there is a need for an expander that does not directly affect the movement of teeth when the mid-jaw suture is enlarged, and that can be equipped with interchangeable expansion screws of different sizes, thereby reducing the correction force and stress applied to the anchor pins and the surrounding supporting bones, and can more effectively distribute the correction force on both sides of the mid-jaw suture, thereby achieving true bony traction. In other words, there is a need for an expander that can produce a more substantial and effective correction effect than the prior art, while eliminating the impact on the alveoli and teeth, and reducing the discomfort of the patient and the inconvenience brought to the clinician. Maxillary underdevelopment may also occur in the forward (sagittal) direction. An orthodontic device called the Keles Facemask includes a maxillary expander and an externally worn orthodontic appliance such as a facebow, which applies lateral force and traction through a molar band ring fixed to the patient's teeth. The jaw movement induced by the Keles device causes the maxillary bone to grow in a forward and downward directional manner. The Keles device relies on the teeth to transmit the correction force to the maxilla, which is not an ideal way because the movement of the maxilla that could have been induced causes the movement of the teeth.

[0007] Another device invented by De Clerck utilizes a bone fixator consisting of Bollard microplates to transmit anterior traction to the maxilla. The De Clerck device can be used for maxillary traction, but it also causes maxillary rotation, resulting in the maxilla moving and growing not only anteriorly but also downwardly, and requires relatively invasive mucosal surgery to install.

[0008] There is a need for an orthodontic device that is improved on the basis of the existing technology and can move and grow the maxillary structure and the nine bones associated with the maxillary bone forward. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1a -c is a schematic diagram of the components of the bone fixation device to be installed intraorally on both sides of the patient's upper jaw suture.

[0010] Figure 2a -b is a schematic diagram of the components of the bony fixed expander device installed on the hard palate processes on both sides of the mid-palatal suture.

[0011] Figure 3 is a schematic diagram of the components of a bony fixed expander device after a pair of first bodies are coupled to the upper jaw of a patient and a first fixed aligner is removed.

[0012] Figure 4a -j is a schematic diagram of the components of a bony fixed expander device consisting of an adjustable aligner and / or a pair of first bodies.

[0013] Figure 5a-b is a schematic diagram of the components of the bony fixed expander device, including a pair of first bodies and a pair of instruments before being connected to the pair of first bodies.

[0014] Figure 6a -d is a schematic diagram of the components of a bony fixed expander device, which includes a pair of first bodies and a pair of instruments connected to the pair of first bodies before and after an adjustable aligner is connected.

[0015] Figure 7a -b is a schematic diagram of the components of a bony fixed expander device including an appliance that increases the anterior-posterior distance between adjustable aligners using an adjustment mechanism.

[0016] Figure 8 is a schematic diagram of a pair of first bodies after the adjustable aligners and the appliance have been removed after the distance between the adjustable aligners has been increased by a clinically desired amount.

[0017] Fig. 9 is a schematic diagram of the pair of first bodies and the pair of third bodies after the pair of third bodies are coupled to the pair of first bodies through respective fifth fasteners.

[0018] Fig.10a -d is a schematic diagram of the components of the bony fixed expander device including a second fixed aligner.

[0019] Fig.11a -b is a schematic diagram of the bony fixed expander device including the additional body.

[0020] Figure 12a-c is a schematic diagram of a bony fixed expander device that does not necessarily rely on the use of a pair of first bodies.

[0021] Fig.13 is a schematic diagram of another embodiment of a bone-fixed expander device that does not require the use of the first body 100a-b.

[0022] Fig.14 is a schematic diagram of a third fixing fastener.

[0023] Fig.15a -c is a schematic diagram of another third fixing fastener.

[0024] Fig.16a -d is a schematic diagram of another bony fixed expander device.

[0025] Fig.17a -c is a schematic diagram of an orthodontic device consisting of a pair of third bodies and an externally worn orthodontic appliance connected to the pair of third bodies.

[0026] Fig.18is a schematic diagram of a pair of first bodies connected to an externally worn orthodontic appliance.

[0027] Fig.19a -b is a schematic diagram of other externally worn orthodontic appliances.

[0028] Fig.20a -b is a schematic diagram of external force applied to an externally worn orthodontic appliance.

[0029] Fig.21a -b is a schematic diagram of another externally worn orthodontic appliance and its use. Summary of the invention

[0030] In one embodiment, the present invention relates to a medical device comprising: at least two bodies, wherein each of the at least two bodies is configured to be coupled to a maxillary bone of a patient and / or an appliance at least partially outside the mouth, and wherein the at least two bodies are configured to apply force to the maxillary bone without coupling the appliance to the patient's teeth. In one embodiment, the present invention further comprises an adjustment mechanism configured to variably maintain the distance between the at least two bodies. In one embodiment, the present invention comprises a coupler configured to couple the ends of the appliance. In one embodiment, the present invention comprises the appliance. In one embodiment, the adjustment mechanism of the present invention comprises a thread. In one embodiment, when the at least two bodies are coupled to the maxillary bone, the adjustment mechanism is configured to cause the hard palate to move in a lateral direction. In one embodiment, when the at least two bodies are coupled to the maxillary bone, the extraoral force applied to the orthodontic appliance causes the maxillary bone to move forward or forward and upward in combination. In one embodiment, when the at least two bodies are coupled to the hard palate, the extraoral traction force applied to the appliance causes the maxillary bone to move forward or forward and upward in combination. In one embodiment, the direction of application of the external traction force is in line with the at least two bodies. In one embodiment, the at least two bodies are configured to be releasably coupled to the orthodontic appliance by a fastener. In one embodiment, the fastener is configured to form an interference fit, a snap fit, and / or a slip fit. In one embodiment, the device comprises an intraoral portion and an extraoral portion, wherein the intraoral portion and the extraoral portion are releasably coupled. In one embodiment, the at least two bodies coupled by an adjustment mechanism are configured to cause the maxillary bone to move laterally. In one embodiment, the adjustment mechanism comprises a body, both ends of which have threads at only one end. In one embodiment, a first body of the at least two bodies comprises at least a first hole and a second hole, each hole being arranged along a respective longitudinal axis, wherein the axis of the first hole is not parallel to the axis of the second hole. In one embodiment, each of the at least two bodies comprises a plurality of threaded holes configured to receive threaded fasteners. In one embodiment, the device comprises a threaded fastener, wherein each of the threaded fasteners comprises two sets of threads, wherein one set of the two sets of threads is configured to cooperate with a corresponding threaded hole of one of the at least two bodies, and the other set is configured to be screwed into the maxillary bone. In one embodiment, the maxillary bone is a hard palate. In one embodiment, each of the at least two bodies includes a plurality of channels, each channel being configured to receive a fastener along a longitudinal axis, wherein the longitudinal axis of at least one channel of the plurality of channels is non-parallel to the longitudinal axis of at least a second channel of the plurality of channels.In one embodiment, the longitudinal axis of the at least one channel is in an angular relationship with the longitudinal axis of the at least second channel, the angle being between 1-60 degrees.

[0031] In one embodiment, the present invention includes a maxillary expander, comprising: a pair of bodies consisting of a first body and a second body, wherein each of the pair of bodies is configured to be fixed to the hard palate of a patient in the oral cavity; a fixed aligner, wherein the fixed aligner is configured to be fastened to the pair of bodies to separate the pair of bodies by a predetermined distance. In one embodiment, the present invention includes a plurality of fasteners; a plurality of holes formed in the pair of bodies; a plurality of matching holes formed on the fixed aligner; the plurality of fasteners are configured to fasten the fixed aligner to the pair of bodies by inserting into the plurality of holes in the pair of bodies and the fixed aligner. In one embodiment, the present invention includes a plurality of holes, including four holes formed in the fixed aligner and two holes formed in each of the pair of bodies. In one embodiment, the present invention includes a plurality of holes formed in each of the pair of bodies; and a plurality of fasteners configured to fasten each of the pair of bodies to the hard palate by inserting the plurality of fasteners into the plurality of holes. In one embodiment, the plurality of holes in each of the pair of bodies includes at least three holes. In one embodiment, the fixed aligner includes two ends, and wherein each of the pair of bodies is configured to couple one of the two ends, respectively. In one embodiment, the fixed aligner comprises a wire. In one embodiment, the fixed aligner comprises a single material. In one embodiment, the expander is configured to be fixed to the hard palate, with a space between the pair of bodies and hard palate surface tissue.

[0032] In one embodiment, the present invention includes a maxillary expander, comprising: a first pair of bodies, wherein each body is configured to be coupled to an upper jaw of a patient; and an adjustable aligner, wherein the adjustable aligner is configured to be releasably fixed to the first pair of bodies to change a first distance between the first pair of bodies by applying an expansion force to the first pair of bodies. In one embodiment, the adjustable aligner includes a second pair of bodies and an expansion screw disposed between the second pair of bodies. In one embodiment, the present invention includes a pair of appliances and at least two supports, wherein each support includes a first end and a second end, wherein the first ends of at least two supports are respectively coupled to and extend from a corresponding one of the first pair of bodies, and wherein the second ends of at least two supports are respectively coupled to the appliance. In one embodiment, the adjustable aligner includes a pair of appliances, each appliance is coupled to a corresponding one of the second pair of bodies, wherein each of the appliances is configured to match the shape of the upper jaw. In one embodiment, the appliance is composed of silicone or acrylic. In one embodiment, the appliance is configured not to be coupled to any of the patient's teeth. In one embodiment, each of the first pair of bodies includes three holes configured to receive fasteners. In one embodiment, the three holes are threaded. In one embodiment, each of the second pair of bodies is configured to be coupled to a corresponding one of the pair of first bodies by at least two screws.

[0033] In one embodiment, the present invention includes a method for applying a corrective force to a patient's maxilla without involving the patient's teeth, the method comprising the following steps: providing at least two bodies; coupling the at least two bodies to a location on the maxilla; coupling an adjustable expander to the at least two bodies; applying a corrective force to the at least two bodies using the adjustable expander to cause movement of the at least two bodies relative to each other and cause expansion of the maxilla. In one embodiment, the adjustable expander includes threads at opposite ends of the expander. In one embodiment, movement of the at least two bodies is used to expand the maxilla bilaterally. In one embodiment, the adjustable expander has threads only at one end of the expander. In one embodiment, movement of the at least two bodies is used to expand the maxilla unilaterally. In one embodiment, the locations are on either side of the mid-jaw suture.

[0034] In one embodiment, the present invention includes a maxillary expander comprising: at least one pair of bodies consisting of a first body and a second body, wherein each of the pair of bodies is configured to be coupled to a maxillary bone of a patient in an oral cavity; and an aligner, wherein the aligner is coupled to the pair of bodies and is configured to separate the pair of bodies by a distance to cause expansion of the maxillary bone, while the aligner or the at least one pair of bodies does not involve any teeth of the patient. In one embodiment, the aligner comprises a fixed aligner or an adjustable aligner. In one embodiment, the at least one pair of bodies is selected from a group consisting of two appliances, two wires, and two fasteners. In one embodiment, each of the pair of bodies is configured to be coupled to a maxillary bone in an oral cavity by at least one fastener. In one embodiment, each fastener comprises two parts. In one embodiment, the two parts comprise a threaded portion, and the two threaded portions are separated by a non-threaded portion. In one embodiment, the two parts are separable. In one embodiment, each of the at least one pair of bodies includes a hole configured to receive a fastener, the body of the fastener being threaded at both the top and bottom ends, wherein the countersunk hole includes threads configured to mate with the top threads of the fastener body. In one embodiment, the hole is a countersunk hole. In one embodiment, the top threads are separated from the bottom threads by a non-threaded portion.

[0035] In one embodiment, the present invention is directed to a method for treating maxillary underdevelopment, comprising the steps of providing a pair of first bodies; coupling the pair of first bodies to the hard palate of a patient; connecting an externally worn device to the pair of first bodies; applying a traction force to the device to cause forward movement of the pair of first bodies. In one embodiment, the method provides an expander between the pair of first bodies; and moving the expander to cause lateral movement of the pair of bodies relative to each other. In one embodiment, the traction force is aligned to cause only forward movement or forward and upward movement of the patient's maxilla. In one embodiment, the traction force produces little or no torque on the pair of bodies. In one embodiment, the direction of application of the traction force passes through the pair of bodies and passes through the point of application of the traction force on the device.

[0036] In one embodiment, the present invention relates to a method for laterally expanding a patient's maxilla, comprising the following steps: coupling a pair of first bodies to the palate in the oral cavity while maintaining a first space between the pair of first bodies; coupling an adjustable aligner to the pair of first bodies; adjusting the adjustable aligner so that an expansion force is applied to the pair of first bodies, thereby changing the first space into a second space; removing the adjustable aligner from the pair of first bodies; and fixing a first fixed aligner to the pair of first bodies to maintain the second space between the pair of first bodies. In one embodiment, the step of creating a first space between the bodies comprises: fixing a second first fixed aligner to the pair of first bodies to create the first space; and then removing the first fixed aligner from the pair of first bodies before installing the adjustable aligner. In one embodiment, the method comprises the step of fixing an appliance to each body. In one embodiment, the method comprises the step of connecting the appliance to the patient's hard palate instead of the teeth. In one embodiment, each of the pair of first bodies is connected to the hard palate on both sides of the midline of the upper jaw. In one embodiment, the method, the step of attaching the body in the oral cavity comprises the step of passing at least three fasteners through each body and inserting into the hard palate.

[0037] In one embodiment, the present invention relates to a method for widening the mid-palatal suture, comprising the following steps: providing a pair of first bodies; providing a pair of acrylic resin appliances; connecting the pair of first bodies and the pair of acrylic resin appliances to the hard palate in the oral cavity while maintaining a first distance between the pair of first bodies; applying an expansion force to the first bodies so that the first distance between the first bodies becomes a second distance.

[0038] In one embodiment, the present invention relates to a method for enlarging the maxilla, comprising the following steps: providing a pair of first bodies; coupling the pair of first bodies to the hard palate; attaching an aligner to the pair of first bodies; maintaining the pair of first bodies below the maxilla and separated therefrom by a certain distance. In one embodiment, the aligner is an adjustable aligner. In one embodiment, the aligner is a first fixed aligner. In one embodiment, the distance is between 0.1-0.3 mm. In one embodiment, the method comprises providing a spacer between the pair of first bodies and the hard palate. In one embodiment, the coupling comprises using a threaded fastener. In one embodiment, the distance is maintained by locking the threads of the threaded fastener into the pair of first bodies.

[0039] In one embodiment, the present invention includes a maxillary expander, comprising: at least two bodies, wherein each of the at least two bodies is configured to be coupled to a hard palate, maintaining a first distance between the at least two bodies and the palate; an expander configured to maintain a second distance between the at least two bodies. In one embodiment, the expander includes a threaded end. In one embodiment, the expander is threaded at only one end. In one embodiment, the expander further includes an aligner. In one embodiment, the aligner includes at least one body configured to be coupled to the at least two bodies. In one embodiment, the aligner includes a fixed aligner. In one embodiment, the aligner includes an adjustable aligner. In one embodiment, the aligner includes an expander. In one embodiment, the at least two bodies are configured to receive a fastener. In one embodiment, the fastener is configured to be received by at least one lateral support extending from each of the at least two bodies. In one embodiment, the fastener includes a screw. In one embodiment, the fastener includes two threaded portions, wherein an outer diameter of one of the two threaded portions is smaller than an outer diameter of the other. In one embodiment, the two threaded portions are separated by a non-threaded portion. In one embodiment, the at least two bodies are arranged parallel to each other.

[0040] In one embodiment, the present invention includes a method for laterally expanding a maxilla, comprising the steps of providing at least two bodies; coupling the at least two bodies to a hard palate; and attaching at least one aligner to the at least two bodies. In one embodiment, the at least one aligner includes a fixed aligner and / or an adjustable aligner. In one embodiment, the at least one aligner includes attaching a fixed aligner and an adjustable aligner. In one embodiment, the at least two bodies include a fastener. In one embodiment, the fastener includes a threaded fastener.

[0041] In one embodiment, the present invention includes a medical device comprising: at least two bodies configured to be coupled to the maxilla of a patient, wherein each of the at least two bodies is configured to couple an appliance that is at least partially extraoral, wherein the appliance is configured to apply traction to the at least two bodies, wherein the two bodies are configured to transmit the extraoral force to the maxilla to cause movement and growth of the maxilla. In one embodiment, the at least two bodies further include a coupler configured to couple the ends of an orthodontic appliance. In one embodiment, the device includes the appliance. In one embodiment, the appliance includes an orthodontic face bow. In one embodiment, an adjustment mechanism, wherein, when the at least two bodies are coupled to the maxilla, the adjustment mechanism is configured to transmit force to the at least two bodies to cause the at least two bodies to apply force to the maxilla to cause lateral movement of the maxilla. In one embodiment, when the at least two bodies are coupled to the maxilla, the extraoral force applied by the appliance to the at least two bodies causes forward movement of the maxilla or a combined forward and upward movement. In one embodiment, the direction of the external traction force applied to the device is in line with the at least two bodies. In one embodiment, the at least two bodies are configured to be releasably connected to the orthodontic appliance. In one embodiment, the releasable connection includes an interference fit, a snap fit and / or a slip fit. In one embodiment, the device includes an intraoral portion and an extraoral portion, wherein the intraoral portion and the extraoral portion are releasably connected. In one embodiment, the first of the at least two bodies includes at least a first hole and a second hole, each hole is arranged along a respective longitudinal axis, wherein the axis of the first hole is not parallel to the axis of the second hole. In one embodiment, each of the at least two bodies includes a plurality of threaded holes configured to receive threaded fasteners. In one embodiment, the device includes a threaded fastener, wherein each of the threaded fasteners includes two sets of threads, wherein one of the two sets of threads is configured to cooperate with a corresponding threaded hole of one of the at least two bodies, wherein the other of the two sets of threads is configured to be threaded into the maxillary bone. In one embodiment, each of the at least two bodies includes a plurality of channels, each channel being configured to receive a fastener along a longitudinal axis, wherein the longitudinal axis of at least one of the plurality of channels is non-parallel to the longitudinal axis of at least a second of the plurality of channels. In one embodiment, the longitudinal axis of the at least one channel is in an angular relationship to the longitudinal axis of the at least second channel, the angle being between 1-60 degrees.

[0042] The foregoing should not limit the present invention as other advantages, benefits and embodiments are also within the scope of the present invention as described in the following detailed description. DETAILED DESCRIPTION

[0043] The accompanying drawings for reference below depict the components and features of the present invention, with reference marks on the drawings. Although the same components may be shown in different figures, it should be noted that when the use of icons is redundant and / or makes the components more difficult to identify, the icons of the same components are not cumulatively used.

[0044] Figure 1a -c is a schematic diagram of the components of the bone fixation device to be installed intraorally on both sides of the patient's upper jaw suture.

[0045] In one embodiment, the bone fixation device of the present invention comprises a pair of first bodies 100a-b ( Figure 1aIn one embodiment, each of the first bodies 100a-b is configured to be attached to the maxillary bone along both sides of the median suture of the upper jaw in the oral cavity. In one embodiment, each body includes a side configured to face the hard palate and a top side opposite thereto. In one embodiment, one or both sides are flat. In other embodiments, the two sides are parallel to each other. In one embodiment, at least a portion of one side is not parallel to the other side. In one embodiment, each first body 100a-b includes a plurality of first holes 101 and a plurality of second holes 102 arranged along the longitudinal axis of each first body. In one embodiment, each first body includes three first holes 101 and two second holes 102. In one embodiment, the first hole 101 passes through the thickness of the first body 100a-b. In one embodiment, the second hole 102 only passes through a certain distance in the first body 100a-b, rather than penetrating. In one embodiment, the bony fixed expander device also includes a first fixed aligner 106 having a plurality of third holes 199 configured to receive a first threaded fastener 110. In one embodiment, the first fastener 110 is formed by a screw, which is configured to be received by the third hole 199 and screwed into the second hole 102 along the thread. In one embodiment, the first fixed aligner 106 has the same number of third holes 199 on the first side on the left and the second side on the opposite right in the transverse direction. In one embodiment, the fixed aligner 106 includes four third holes 199. In one embodiment, the fixed aligner 106 includes a single integral body. In one embodiment, the first fixed aligner 106 includes a plate-like structure. In one embodiment, the first fixed aligner 106 includes an H-shaped geometry. In other embodiments, the first fixed aligner includes a geometry that can have holes formed at four corners. In one embodiment, the third holes 199 of the first fixed aligner 106 are configured to have a longitudinal spacing "B", which enables them to be connected to the corresponding second holes 102 on the first body 100a-b by inserting the first fastener 110 therein. In one embodiment, when the pair of first bodies 100a-b are connected to the first fixed aligner 106 by fasteners, the lateral spacing of the third holes 199 causes the pair of first bodies 100a-b to be separated by a distance "Z". In one embodiment, the first hole 101 includes a channel, wherein the channel is sunk into the first body 100a-b to a first depth, the first depth being less than the thickness of the first body, so that the channel is threaded along the first depth and is configured to be threaded when the second fastener 111 ( Figure 2a-2b ) is inserted into the bottom of the first body 100a-b to receive its threaded upper end. In one embodiment, the first fixed aligner 106 and each first body 100a-b are sized to have Figure 1a and 1b Dimensions shown.

[0046] In one embodiment used (see Figure 1c ), place the side of the first fixed aligner 106 facing the hard palate on the corresponding body 100a-b, insert the corresponding first fastener 110 into the third hole 199 of the first fixed aligner 106, and screw the corresponding fastener 110 into the second hole 102 to connect the first fixed aligner 106 to the pair of first bodies 100a-b. After the first fixed aligner 106 and the pair of first bodies 100a-b are connected, the combination is placed on the hard palate of the patient so that one of the first bodies 100a-b is on one side of the mid-jaw suture of the patient, and the other of the first bodies 100a-b is on the other side of the mid-jaw suture.

[0047] Figure 2a -b is a schematic diagram of the components of the bony fixed expander device installed on both sides of the midline suture of the hard palate.

[0048] In one embodiment of use, after the first fixed aligner 106 and a pair of first bodies 100a-b are combined, they are fixed on both sides of the median suture on the hard palate, and the combination is mounted on the hard palate with a plurality of threaded second fasteners 111. In one embodiment, each first body includes a plurality of threaded first holes 101, which connect the one side of the pair of first bodies facing the hard palate and the other side opposite. In one embodiment, each of the pair of first bodies 100a-b includes three threaded first holes 101. In one embodiment, the screwable second fastener 111 includes a bottom configured to be screwed into the hard palate through a set of first threads and a top configured to be screwed into the first hole 101 through a second set of threads. In one embodiment, the first set of threads and the second set of threads are separated by a non-threaded portion. In one embodiment, the outer diameter of the first set of threads is smaller than the outer diameter of the second set of threads. In one embodiment, the size of the second fastener 111 is determined as Figure 2b . In one embodiment of use, the bottom of the second fastener 111 is inserted through the corresponding first holes 101 in the pair of first bodies 100a-b, and after insertion, the bottom of the second fastener 111 is threadedly screwed into the hard palate. When the bottom of the second fastener is inserted into the hard palate, the top of the second fastener 111 is screwed into the corresponding thread of the first hole 101 in the pair of first bodies 100a-b until the surface portion of the top of the second fastener abuts against the surface portion of the first hole 111. In one embodiment, a torque between 0.1nm-0.6nm is applied to the second fasteners to insert them into the two cortical bones of the maxillary process and achieve fixation against and within the first body. In one embodiment, when the second fastener 111 abuts against and within the first body 100a-b, a fixed rigid structure is formed, which is made more rigid by inserting the second fastener into the hard palate.

[0049] In one embodiment, before the bottom of the second fastener 111 is inserted into the hard palate, one or more spacers 50 are inserted between the side of the pair of first bodies 100a-b facing the hard palate and the hard palate. The purpose of one or more spacers is to determine a distance between the pair of first bodies 100a-b and the hard palate membrane tissue. In one embodiment, the distance is 0.1mm-0.3mm. In one embodiment of use, the second fastener 111 is screwed into the hard palate until the pair of first bodies 100a-b gently rests against the one or more spacers 50, and the one or more spacers gently rest against the hard palate tissue. In one embodiment, the spacer 50 is made of soft silicone. In another embodiment, the spacer 50 is made of a material that can be dissolved by fluids in the oral cavity. In one embodiment, the spacer 50 is made of a material composed of gluten-free wheat, yeast, salt and water, which is baked into a thin sheet that can dissolve very quickly when it comes into contact with oral secretions. In other embodiments, the spacer is made of resin or polycarbonate. After one or more spacers 50 are inserted and a pair of first bodies 100a-b are mounted on the hard palate, in one embodiment, the spacers are removed or dissolved in situ, thereby forming an open space / gap between the first bodies and the hard palate. In one embodiment, the space / gap is such that there is no or minimal contact between the first bodies 100a-b and the hard palate, which reduces the likelihood of tissue necrosis. In this way, since the contact between the first bodies 100a-b and the hard palate is reduced, damage and irritation (necrosis) to the soft tissue of the upper jaw is also reduced, and the force acting on the maxillary bone is maximized. The present invention is not limited to forming a space / gap by using the described spacers, as other methods may also be used, for example, by temporarily fixing a pair of first bodies to the teeth with a surgical guide, thereby creating a space / gap during the insertion of the second fastener 111, after which the temporary fixation device may be removed. In addition, although this article describes that the top of the second fastener is threaded into a pair of first bodies so that the second fastener 111 is rigidly connected to the body and fixed to a position below the upper jaw, the present invention is not limited to using threads to achieve this purpose. In other embodiments, in addition to or instead of the second set of threads described above, a biocompatible resin or adhesive can be used; or a clamp, lock, or interference fit type connection mechanism can be used to connect the second fastener 111 to a pair of first bodies.

[0050] Figure 31 is a schematic diagram of the components of a bony fixed expander device after a pair of first bodies are coupled to the patient's upper jaw and the first fixed aligner is removed. In one embodiment of use, after the second fastener 111 is coupled to the patient's hard palate, the first fastener 110 is unscrewed from the first body 100a-b and the first fixed aligner 106 is separated and removed from the pair of first bodies 100a-b. After removal, the pair of first bodies 100a-b will be separated by a distance "D" determined by the first fixed aligner 106 (see Figure 1b ) is determined by the distance “B”.

[0051] Figure 4a -j is a schematic diagram of the components of a bone fixed expander device consisting of an adjustable aligner and / or a pair of first bodies, wherein the aligner and the body are configured to promote movement and growth of the patient's maxillary bone structure. In one embodiment, the bone fixed expander device of the present invention includes an adjustable aligner 150 (see Figure 4a). In one embodiment, the adjustable aligner 150 includes a pair of second bodies 151a-b, each of which is connected by at least one adjustment mechanism formed therebetween. In one embodiment, each of the second bodies 151a-b is elongated along an axis. In one embodiment, each axis is generally parallel to the other axis when connected by the adjustment mechanism 152. In one embodiment, the adjustment mechanism 152 includes a two-end expansion screw with threads on both ends. In one embodiment, the adjustment mechanism 152 is configured to rotate about the pair of second bodies 151a-b so that each second body is moved closer to or farther from each other by the end of the adjustment mechanism rotating with the threads of the threaded hole in each second body. In one embodiment, each pair of second bodies 151a-b is configured to have a hole sized to slidably receive the end of one or more stabilizing rods 175 for insertion or passage. In one embodiment, each second body 151a-b includes a plurality of threaded fourth holes 198 configured to pass through the bottom surface of the second body 151a-b facing the hard palate and its top surface. In one embodiment, the fourth holes 198 are spaced longitudinally to match the longitudinal spacing of the second holes 102 in each of the pair of first bodies. In one embodiment of use, the adjustment mechanism 152 is rotated to a position that enables the threaded first fastener 110 to be aligned and easily inserted into the corresponding hole 102 in each body 100a-b through the corresponding fourth hole 198 of the adjustable aligner 150. After coupling in this manner, the pair of second bodies 151a-b will be spaced the same initial distance "D" from each other as the first bodies 101a-b. After coupling, the adjustment mechanism 152 can be used to increase or decrease the lateral distance between the two pairs of second bodies 151a-b, the two pairs of first bodies 100a-b, and the first fastener 110, and the change in this distance can be used to treat patients with underdeveloped maxillary bones by bidirectionally expanding the maxillary bone structure and the nine bones connected to the maxillary bones. In one embodiment, the adjustment mechanism 152 is not formed by a bidirectional expansion screw having threads on both ends as described above, but instead is a unilateral expansion screw having threads on one end and no threads on the other end (see Figure 4d). In one embodiment, the unthreaded end is inserted into and passes through the hole of one second body 151a-b and can rotate freely in the hole, while the threaded end is connected to the threaded hole in the other second body by its thread. The unthreaded end is fixed by a retainer such as a ring to limit the longitudinal movement in the hole relative to the second body. When the adjustment mechanism 152 rotates, one of the second bodies 151a-b remains fixed while the other moves. In one embodiment of use, it has been determined that a bone fixed expander device including a unilateral expansion screw as described above can be used to treat maxillary asymmetry. Although the above description describes the increase in the distance between the two second bodies 151a-b by rotation, it is conceivable that other mechanisms that can cause the second bodies 151a-b to move are also within the scope of the present invention, such as springs, micromotors or other passive or active actuators that can be used to achieve linear movement between the second bodies. In one embodiment, a total of six fasteners are required to connect the two first bodies 100a-b to the hard palate, three for each first body 100a-b. Compared to using two second fasteners in each first body 100a-b, the present invention uses three second fasteners in each first body, which reduces the force on the fastener when the first body moves, and also reduces the force on the local bone supporting the fastener. When more second fasteners 111 are used, the resistance generated by the upper jaw resisting the movement of the second body 151a-b is applied to the fastener and dispersed, reducing the force on any one fastener. Therefore, in other embodiments, as needed or desired, it is within the scope of the present invention to use more than three second fasteners 111 and more than three holes in the first body for receiving the fasteners in order to reduce the force on the fastener and / or the local bone supporting the fastener.

[0052] See also Figure 4e, although some of the above-described embodiments use a fixed aligner 106 to provide initial alignment with the pair of first bodies, in one embodiment, such alignment can be provided without the use of an aligner 106. In one embodiment, a first threaded fastener 110 is inserted and passed through the corresponding fourth holes 198 of a pair of second bodies 151a-b and then screwed into the corresponding second holes 102 of a pair of first bodies 101a-b. After being coupled in this manner, the pair of first bodies 100a-b will be spaced apart by an initial distance, which is determined by how many turns the expansion mechanism 152 or 162 has been rotated. Subsequently, the pair of first bodies 100a-b can be coupled to the upper jaw at this initial spacing by first inserting four second fasteners 111 into the first holes 101 at both ends of the pair of first bodies 100a-b. After being coupled to the upper jaw, the pair of second bodies 151a-b can be removed and, if desired, the coupling of the pair of first bodies to the hard palate can be reinforced by inserting two more second fasteners 111 into the first holes 101 in the middle of the pair of first bodies 100a-b. After the first body 100a-b is connected to the upper jaw through the complete complementarity of the second fastener 111, the pair of second bodies 151a-b can be reconnected to the pair of first bodies 100a-b for backup by inserting the threaded first fastener 110 into the fourth hole 198 and then further inserting it into the corresponding second hole 102 of the pair of first bodies 100a-b.

[0053] It has been found that when it is desired to minimize the initial distance between the second bodies 151a-b (see Figure 4f The adjustable aligner 150 in FIG. 1 does not have the stabilizing rod 175), for example, when the first body 100a-b or the second body 151a-b is initially intended to be installed as close to the mid-jaw suture as possible, such an arrangement maximizes the force transmitted to the mid-jaw tissue that resists movement. Figure 4g As shown, although in one embodiment, the adjustment mechanism 152 between the second bodies 151a-b enables a minimum distance of 2.5 mm between the second bodies, it also determines a maximum distance of 10 mm and also determines the minimum distance between the second bodies 151a-b. Figure 4f The outer end of the adjustment mechanism 152 may extend outwardly from the second body at the minimum distance shown. However, it can be determined that in some cases, when the outer end of the adjustment mechanism extends too far, it may interfere with the patient's tongue or oral anatomy. In addition, when an expansion force is applied to the second body 151a-b, in a narrow palate, the body may begin to enter the palate wall tissue due to insufficient space in the lateral direction.

[0054] Figure 4hAs shown, in order to minimize or eliminate interference with the patient's oral anatomy, in some embodiments, the adjustable aligner 150 includes an adjustment mechanism 172. In one embodiment, the adjustment mechanism 172 includes a retractable expansion screw mechanism. In one embodiment, the expansion screw mechanism includes a housing 172a having two threaded holes at opposite ends, and two threaded rods 172b each having a first threaded end that can be threaded into the corresponding threaded hole, and a second threaded end that is screwed into the corresponding threaded hole of the second body.

[0055] In one embodiment of use, rather than using only one of the adjustment mechanisms 152 or 172 to achieve a desired expansion of the patient's maxilla / palate, it is desirable to use both simultaneously. For example, where it is desirable to initially position a first or second body proximately above the mid-palatal suture, and where it is desirable to subsequently expand the first or second body more than the adjustment mechanism 152 can provide without interference, an adjustable aligner 150 including the adjustment mechanism 152 may be used to achieve a first distance between the second bodies (e.g., a distance of 10 mm), after which the first distance is achieved, the adjustable aligner 150 may be removed and replaced with an adjustable aligner 150 including the adjustment mechanism 172 to achieve a second distance (15 mm) between the second bodies. The above description of the initial and final distances achieved using the adjustment mechanisms 152 and 172 is intended to be exemplary, as in other embodiments, the adjustment mechanisms 152 and 172 may be configured to achieve smaller or larger distances, for example, by appropriate selection of their lengths and / or modification of the bodies.

[0056] Figure 5a -b is a schematic diagram of the components of the bone fixed expander device, including a pair of first bodies and a pair of instruments before being connected to the pair of first bodies. In some cases, due to the bone anatomical structure being too thin or too thick, the combination of the adjustable aligner 150, the first body 100a-b and the fastener 111 may not be sufficient to achieve the clinically desired maxillary expansion. Therefore, in order to further reduce the stress caused by the threaded fastener on the bone, in one embodiment, the bone fixed expander device of the present invention includes a pair of instruments 120a-b. In one embodiment, each instrument includes at least one extension support 125 (see Figure 5b). In one embodiment of use, the first end 130 of each support 125 is configured to be coupled to the corresponding second hole 102 of the pair of first bodies 100a-b, and the opposing second end 131 of the support is embedded in a corresponding plate 132. In one embodiment, each plate comprises acrylic or other sufficiently rigid biocompatible material as known to those skilled in the art of dental equipment. In one embodiment, when embedded in the plate 132, the first end 130 of each extension support 125 is spaced the same distance "Y" as the second hole 102 in each first body 100a-b. In one embodiment, each first end 130 includes a hole configured to receive a corresponding fastener 110. In one embodiment, the plates 132 are made and sized based on a mold or digital scan of the oral cavity so that when used in the oral cavity, they rest comfortably against the tissue of the upper jaw without directly touching any teeth.

[0057] Figure 6a -d is a schematic diagram of the components of a bone fixed expander device, the device including a pair of first bodies and a pair of instruments coupled to the pair of first bodies before and after the adjustable aligner is coupled. In one embodiment of use, a threaded first fastener 110 is inserted through the instruments 120a-b (see Figure 6a -b) of the extension support 125, and the corresponding fourth hole 198 of the adjustable aligner 150 are screwed into the corresponding second holes 102 of the first body 100a-b, so that the three parts become one, and when they are connected to the upper jaw and expanded by the adjusting screw 152, additional correction force can be applied to both sides of the upper jaw midline. In one embodiment (see Figure 6c ), rather than initially providing the fixtures 120a-b as separate units from the adjustable aligner 150, each fixture is provided as part of a respective second body 151a-b, so that the adjustable aligner 150 and each fixture can be attached to the pair of first bodies 100a-b as a whole. Figure 6d Such an integral body is shown in which a first end of one set of support members 125 is integrated into the second body, and the other opposite set of end portions may be molded thereon by a plate (not shown).

[0058] Figure 7a-b is a schematic diagram of the components of a bony fixed expander device including an appliance with an adjustment mechanism to increase the distance between the adjustable aligners before and after. In one embodiment of use, the adjustable aligner 150 is coupled to a pair of first bodies 100a-b, and the distance between the pair of second bodies 151a-b is increased by rotating the adjustment mechanism 152, the increase in distance resulting in an increase in the distance between the pair of first bodies 100a-b and the appliance 120a-b. In an embodiment, the increase in distance is achieved by using a wrench, an activation key, or other device configured to move or rotate the adjustment mechanism 152 / 162. In one embodiment, gradually increasing the distance between the second bodies 151a-b causes lateral expansion of the patient's maxilla, wherein the increment determines the amount of expansion that can potentially be achieved. During use of the adjustable aligner 150, it is determined that a portion of the second fastener 111 at the location where it is inserted into the hard palate is exposed due to the small space / gap created between the hard palate and the pair of first bodies (see the above discussion of using the spacer 50 to create the space / gap in Figure 2). Compared to the case where the small space does not exist, the presence of the space will lead to an increase in the stress to which the second fastener is subjected when inserted into the hard palate, by the resistance to movement of the mid-jaw of the upper palate to which one end of the aforementioned second fastener is connected and the movement applied by the second body 151a-b to which the other end of the second fastener is connected. The force applied to the fastener 111 means that the hard palate will also be subjected to this stress at each insertion point. It is therefore determined that it is desirable to reduce the local stress applied to the fastener 111 and the maxilla. One method of reducing fastener stress includes distributing the stress over more fasteners as described above. However, when the instruments 120a-b are also used, because their plates 132 are against the upper palate, the expansion of the second body 151a-b will cause the plates to apply force to the soft palate and then to the hard palate, and this force can be used at least in part to overcome the resistance to maxillary expansion, which in turn can be used to further reduce the stress to which the fastener is subjected. The three methods of screwing the top end of the second fastener 111 into the corresponding threaded holes of the first body 100a-b, using more than two second fasteners 111 for each first body, and using the instrument as described above can be used alone or in combination to stabilize the first body 100a-b and the second body 151a-b, thereby eliminating the need for molar or tooth-borne fixtures. By eliminating the transmission of force to the teeth, many benefits can be obtained, namely, a better orthopedic effect relative to the influence of the alveolar or teeth. Better orthopedic effects are associated with greater airway and aesthetic benefits. Moreover, since the teeth are not involved and there is no contact with the teeth, many risks are eliminated, including root resorption, tooth tilting and possible scissor bite. Although it is best not to involve and not touch the teeth, it should be understood that the embodiments of the present invention described above or further below do not hinder connection with the teeth when it is desired or necessary to achieve a specific clinical result.

[0059] Figure 8 is a schematic diagram of a pair of first bodies after the adjustable aligners and the device are removed after the distance between the adjustable aligners is increased by a clinically desired amount. In one embodiment of use, after the distance between the pair of first bodies 100a-b is increased to the clinically desired distance "D2", the first fastener 110 is unscrewed and the adjustable aligner 150 is removed, and the device 120a-b, if used, is also removed. In one embodiment, in order to re-grow the midline suture of the upper jaw while maintaining the distance "D2", a pair of third bodies 170a-b are fixed above the pair of first bodies 100a-b. In one embodiment, each third body 170a-b includes a plurality of fifth holes 195, each fifth hole 195 is spaced longitudinally at the same interval as the second hole 102 of each first body. In one embodiment, the hole 195 connects the side facing the upper jaw and the top surface of the pair of third bodies 170a-b and is configured to receive the fifth fastener 191 therethrough.

[0060] Fig. 9 It is a schematic diagram of a pair of first bodies and a pair of third bodies connected together, wherein the pair of third bodies 170a-b and the pair of first bodies are connected by inserting respective fifth fasteners 191 into respective fifth holes 195, and screwing respective fifth fasteners into respective second holes 102 of the pair of first bodies 100a-b.

[0061] Fig.10a-d is a schematic diagram of the components of the bony fixed expander device including the second fixed aligner. In one embodiment of use, in order to maintain the distance "D2" when the first body 100a-b and the third body 170a-b are connected, the second fixed aligner 196 is used. In one embodiment, the second fixed aligner 196 includes a body configured to have a shape that maintains the distance "D2" during the holding / stabilization stage, that is, the stage when the patient's maxillary suture grows again with the bone and maintains the distance "D" by itself without using the embodiment of the present invention. In one embodiment, the second fixed aligner 196 includes a wire that is bent into a shape that allows its two ends 166 and 167 to be inserted into the sixth hole 197 of each third body 170a-b, respectively. In one embodiment, the second fixed aligner 196 is a single piece made of stainless steel spring metal. In one embodiment, the second fixed aligner 170a-b is made of a material that is strong enough to maintain the distance "D2" during the holding / stabilization stage. Using a fixed aligner 196 during the holding / stabilization phase, rather than an adjustable aligner, means that the appliance is smoother and less bulky, thereby allowing the tongue more room to move during this phase. In addition, it is more hygienic to remove the adjustable aligner after expansion is achieved. However, in other embodiments, after expansion is achieved, the adjustable expander can be left in place without further adjustment to effectively function as a fixed aligner.

[0062] Fig.11a -b is a schematic diagram of a bony fixed expander device including additional bodies. In some embodiments, a patient may require a certain amount of stability during maxillary expansion that is not optimally provided by some of the embodiments described above, depending on the patient's age, gender, bone density, or desired clinical outcome. Therefore, in one embodiment, the bony fixed expander is equipped with at least two additional bodies 165. In an embodiment, the body 165 includes an extension arm, a rod, a hard wire, or other structure configured to provide an additional stabilization point for the bony fixed expander without relying on tooth support. In one embodiment, at least one body extends from each first body 100a-b (see Fig.11a ) or from each second body 151a-b (see Fig.11b) extends laterally. In one embodiment, one end of each body 165 is integral with each body 165 of the first body 100a-b or the second body, and the other end includes an attachment mechanism 164 configured to connect to the hard palate. In one embodiment, each attachment mechanism is configured to receive a fastener 163, which is configured to provide a releasable connection between the attachment mechanism and the hard palate. In an embodiment, the fastener 163 can be a screw, a rivet, a pin, an interference mechanism biocompatible adhesive or other dental fasteners known in the art. The use of the body 165 provides additional connection points through which forces can be distributed to more points of attachment of the bony fixed device to the upper jaw.

[0063] Figure 12a-cSchematic diagram of a bony fixed expander device that does not necessarily rely on the use of a pair of first bodies. In one embodiment, the bony fixed expander includes an adjustable aligner 151 or a fixed aligner 106. In one embodiment, the bony fixed expander includes a plurality of sixth fasteners 136. A bottom end of each sixth fastener 136 is configured to be inserted into the maxillary bone, and the other opposite top end is configured to receive and connect the fixed aligner 106 or the adjustable aligner 150. In one embodiment, each sixth fastener 136 is determined by the spacing of the holes formed by the fixed aligner 106 in its respective alignment and spacing relative to other sixth fasteners connected to the patient's hard palate. In one embodiment, the top end of the sixth fastener 136 is initially connected to the fixed aligner 106 by an interference fit with a recess formed at the bottom of the hole in the fixed aligner 106, and after assembly, each sixth fastener extends from the hole and is aligned with the hole. In one embodiment of use, the fixed aligner 106 and the sixth fastener 136 are aligned and positioned against the upper jaw so that an equal number of sixth fasteners 136 are located on both sides of the mid-palatal suture. In one embodiment of use, each fastener is then connected to the hard palate. In one embodiment, the bottom end of each sixth fastener 136 includes threads, which pass through the holes in the fixed aligner 106 and are inserted into the hard palate by rotating with the top of each fastener. In one embodiment of use, when each sixth fastener 136 is inserted to the required depth, the top of the sixth fastener is removed from the groove in the hole of the fixed aligner, so that the fixed aligner 106 is disengaged from the sixth fastener 136. In one embodiment of use, the adjustable aligner 150 is connected to the sixth fastener 136. In one embodiment, the attachment mechanism is equipped with or is arranged in each second body 151a-b, and its size is separated by the longitudinal spacing that is the same as the spacing of the holes of the fixed aligner 106 in the longitudinal direction. It is determined to be longitudinally spaced apart with the same longitudinal spacing as the first body 151a-b. In one embodiment, the second bodies 151a-b are spaced apart using the adjustment mechanism 152 prior to coupling the sixth fastener 136 so that the attachment mechanisms in the second bodies 151a-b have the same lateral spacing as the holes of the fixed aligner 106. In one embodiment, each attachment mechanism in the adjustable aligner 150 is configured to retain the adjustable aligner 150 when the adjustable aligner 150 is placed over the sixth fastener 136. In an embodiment, the attachment mechanism includes a hole, a snap-fit ​​mechanism, an interference type mechanism, an adhesive, or a combination of the foregoing, which is configured to allow the sixth fastener 135 to be coupled to and detached from the adjustable aligner 150. In one embodiment, the attachment mechanism includes a hole in each of the second bodies 151a-b and the seventh fastener 135 provided together, wherein the seventh fastener includes a fastener, and the top end of the sixth fastener 136 is provided with a hole for receiving the bottom end of the seventh fastener 135.In one embodiment, the top end of the sixth fastener 136 and the bottom end of the seventh fastener 135 are threaded. In one embodiment of use, after the adjustable aligner 150 is positioned above the sixth fastener 136, the seventh fastener 135 is inserted into the hole of the adjustable aligner and coupled to the sixth fastener 136. Subsequently, the adjustable aligner 151 can be used to generate a corrective expansion force to the aligned and installed sixth fastener 136 without using the first body 100a-b described above. In addition, the sixth fastener 135 can be inserted into the desired depth of the upper jaw, and in one embodiment, it can be installed so that the top end of the sixth fastener 135 can protrude a specific distance below the upper jaw, in which case one or more spacers 50 as described above may not be required to achieve the desired installation space / gap between the adjustable aligner 150 and the upper jaw tissue. Although Figures 12a-b show four sixth fasteners 136 and seventh fasteners 135, it should be understood that other numbers of fasteners and attachment mechanisms can be implemented and used, for example, six or more sixth and seventh fasteners and six or more attachment mechanisms of each can be used as desired or required to distribute the forces borne by the fasteners.

[0064] Fig.13 is a schematic diagram of another embodiment of a bone fixed expander device that does not require the use of the first body 100a-b.

[0065] In another embodiment, without the need to use the pair of first bodies 100a-b discussed above, each second body 151a-b includes a plurality of threaded fourth holes 198, which are configured to connect the bottom and top surfaces of the second body 151a-b against the hard palate. Although four threaded holes 198 are discussed herein, the present invention contemplates that other numbers of fourth holes may be constructed within each second body 151a-b to better distribute force and reduce stress on the screws and bones. In one embodiment of use, a pair of second bodies 151a-b are first connected to the upper jaw by inserting the bottom end of the second fastener 111 into the fourth hole 198, and then, after insertion, the bottom end of the second fastener 111 is threadedly screwed into the hard palate. During the insertion of the bottom end of the second fastener 111 into the hard palate, its top end is screwed into the corresponding threaded fourth hole 198 in the second body 151a-b. In one embodiment, before the second fastener 111 is fully screwed into the upper jaw, a spacer 50 can be used to create a distance between the pair of second bodies 151a-b and the upper jaw. In one embodiment, when used without a pair of first bodies as described above, the pair of second bodies 151a-b can be coupled to or include a device, arm, rod, hard wire or other structure configured to provide additional stabilization points for the above-mentioned bone fixed expander.

[0066] The prior art devices are compared with various embodiments of the present invention, including:

[0067] Prior art devices: expander assembly connected to the teeth via molar bands and to the upper jaw via 4 fasteners, each of which contains a single set of threads configured to be screwed into the upper jaw (i.e., the Moon device mentioned in the background section)

[0068] ● Example 1: An expander assembly using an adjustable aligner 150 coupled to the upper jaw via a pair of first bodies 100a-b and six fasteners 111, wherein each fastener includes two sets of threads, and one set of threads is screwed into the pair of first bodies and the other set of threads is screwed into the upper jaw (see Figure 2b ).

[0069] ● Embodiment 2: An expander assembly using a set of two bodies 120a-b (see Figure 6b ) and a pair of first bodies 100a-b and six fasteners 111 coupled to an adjustable aligner 150 of the upper jaw, wherein each fastener includes two sets of threads (see Figure 2b ), wherein one set of threads is screwed into the first body and the other set of threads is screwed into the upper jaw (see Figure 2b ).

[0070] The following peak bone stresses were noted:

[0071] ●Existing technical equipment: 98MPa

[0072] • Example 1: 84 MPa (compared with the prior art, it can reduce the stress on the fasteners and bones).

[0073] • Embodiment 2: 50 MPa (compared with the prior art, the stress on the fastener and the bone can be reduced).

[0074] The following peak maxillary stresses were noted:

[0075] ● Existing technology equipment: 0.479

[0076] • Example 1: 0.426 (provides more uniform strain on the mid-jaw suture compared to the prior art).

[0077] • Example 2: 0.397 (provides a more uniform strain on the mid-jaw suture compared to the prior art and Example 1).

[0078] Fig.14 1901 is a schematic diagram of a third fixing fastener. In one embodiment, the third fixing aligner 1901 comprises a surgical guide configured to accurately position and fix a pair of first bodies 100a-b on both sides of the mid-palatal suture on the hard palate.

[0079] In one embodiment, a casting of the patient's intraoral geometry is obtained, a mold is made from the casting, and an appliance in the form of a third fixed aligner 1901 is made from the mold, the surface of the appliance facing the upper jaw having features that match the patient's upper jaw, maxilla and / or dentition. In another embodiment, a digital scan (e.g., a CBCT scan of the maxilla and / or the upper jaw) is performed by a computer-controlled imaging device to obtain an image of the patient's upper jaw, jaws and / or dentition and store it in a computer memory (e.g., an STL format file). The stored image can then be used to form a third fixed aligner 1901 using a third party's printing or processing equipment, and the side of the aligner facing the upper jaw forms matching features with the patient's upper jaw, jaws and / or dentition. In one embodiment, the fixed aligner includes a biocompatible material suitable for oral use known to those skilled in the art. In one embodiment, the third fixed aligner 1901 includes a hole 1936 formed in the third fixed aligner 1901 to guide the second fastener 111 to be inserted into the hard palate. In one embodiment, the hole 1936 is formed along a peripheral recess 1937 formed in a third fixed aligner configured to receive the first body 100a-b. In one embodiment of use, after being mounted on the patient's soft palate, the third fixed aligner 1901 is used to guide the first body 100a-b and the fastener 111 to positions on both sides of the mid-palatal suture so that the fastener 111 can be screwed into the hard palate until the threads at its top are fixed in the pair of first bodies. In one embodiment, the portion of the third fixed aligner 111 that matches the dentition can be inserted against the patient's dentition, thereby minimizing the movement of the first body about the maxilla when the fastener 111 is inserted. In one embodiment of use, the third fixed aligner 1901 is used to define a space / gap between the first body 100a-b and the upper jaw. In order to obtain the desired space / gap, the third fixed aligner 1901 can be manufactured with a thickness of the area around the hole 1936 according to the specific desired space / gap, for example, the space / gap is about 0.1-0.3mm. The third fixed aligner 1901 can be made of a relatively rigid but brittle material, such as a biocompatible acrylic, resin or polycarbonate. In one embodiment, the third fixed aligner 1901 is provided with one or more thinned regions 1938 so that the fixed aligner can be removed by subsequently breaking at the thinned regions to remove fragments of the aligner around the fasteners and underneath the pair of first bodies 100a-b, so that the aligner can be removed without removing or unscrewing the fasteners 111.

[0080] Fig.15a-c is a schematic diagram of another third fixed fastener. In one embodiment, the third fixed aligner 2001 is manufactured using the techniques discussed above with reference to the third aligner 1901. In one embodiment, the third fixed aligner 2001 includes an alignment feature 2117 configured to receive a pair of first bodies 210a-b, and a plurality of holes 2119 configured to receive a plurality of fasteners including fasteners 2116 and fasteners 2111. In one embodiment, the plurality of holes 2119 include holes configured to match the spacing of corresponding holes 2115 in the first fixed aligner 2106 and the first bodies 2100a-b. In one embodiment of use, the first body 2100a-b is abutted against and / or on a feature 2117 on one side of the third fixed aligner 2001, the first fixed aligner 2106 is abutted against the opposite side of the third fixed aligner 2001, and the fastener 2116 is inserted through the hole 2119 into the hole 2115 and into the hole in the first body to connect the first body and the first fixed aligner together to form an assembly, wherein the third fixed aligner is sandwiched between the first body and the first fixed aligner. In one embodiment of use, the assembly is then abutted against the upper jaw and a plurality of fasteners 2111 are used to secure the assembly to the upper jaw. In one embodiment of use, the third fixed aligner 2001 has a thickness T1 in an area of ​​the first body 2100a-b configured to receive the feature 2117, wherein the thickness T1 is thicker than the thickness T2 of the pair of first bodies 2100a-b, and causes a side of the first body 2100a-b in the component mounted on the upper jaw that faces the upper jaw to be separated from the upper jaw by a distance that depends on the difference between the thickness of the third fixed aligner 2001 and the thickness of the pair of first bodies, such as a distance between approximately 0.1-0.3 mm.

[0081] In one embodiment, the third fixed aligner 2001 and the first fixed aligner 2106 include holes 2139 configured to have a certain size that allows a plurality of fasteners 2111 to be fully received therein and allows the second fixed aligner 2106 and the third fixed aligner 2001 to be subsequently removed by removing the fasteners 2116 while allowing the pair of first bodies 2100a-b to be fixed to the hard palate by the fasteners 2111, the configuration allowing the pair of first bodies to be spaced a certain distance from the upper jaw and allowing the adjustable aligner 150 to be coupled thereto. In one embodiment, the third fixed aligner 2001 is configured to be fixed to the patient's dentition and sandwiched between the first bodies 2100a-b and the fixed aligner 2106 so as to abut the bodies against a specific location in the patient's mouth. The thickness of the first body 2100a and the counterbore formed therein serve to further align the fastener 2111 so that the first body 2100a-b can be accurately mounted on the jaw and the fastener 2111 can be inserted into the hard palate.

[0082] Fig.16a -d is a schematic diagram of another bone fixation device. In some embodiments, it may be difficult to fix some of the above embodiments in the patient's mouth due to the "V" shape, narrow or limited upper jaw. For these and other shapes of upper jaws, the second threaded fastener 111 perpendicular to the upper jaw may be difficult to fix in place due to the limited flat surface area.

[0083] In one embodiment, the bone fixation device includes a pair of first bodies 100c-d (see Fig.16b -c). In one embodiment (see Fig.16a), each of the pair of first bodies 100c-d includes a second hole 102, which defines a longitudinal channel that is angled (rather than parallel) relative to the longitudinal channel defining the first hole 101. This allows the pair of first bodies 100c-d to be fixed to a pair of second bodies 151a-b in a manner similar to that described in other previous embodiments, but the axis of the second threaded fastener 111 inserted into the second hole 102 of one of the pair of first bodies 100c-d will be at a certain angle relative to the longitudinal axis of the second fastener inserted into the other of the pair of first bodies. In one embodiment, an extension portion 173 can be provided to the first body 100c-d to provide additional structural support for the second hole 102. In one embodiment, the pair of first bodies 100c-d with the extension portion 173 include an integral element. In other embodiments, the first body 100c-d and the extension portion can be connected together by various attachment methods. It should also be noted that inserting the screw at a certain angle can have more surface contact with the bone compared to vertical insertion. Additionally, angled screws can be designed to be inserted into the mid-palatal suture differently than vertical screws, which may be desirable. Fig.16a In the embodiment of -c, the first body is configured to cooperate with the second body along an extension portion 173 of the top surface that is not parallel to the bottom surface of the first body. In other embodiments, the extension portion can be omitted so that the top surface and the bottom surface of the first body are substantially flat and / or parallel to each other (see Fig.16d ).

[0084] In one embodiment, the angle of the longitudinal axis of the second hole 102 in each body 100c-d relative to the longitudinal axis of the first hole 101 is approximately between 0-90 degrees, depending on the shape and anatomy of the particular patient's upper jaw. In other embodiments, the angle of the longitudinal axis of the second hole 102 relative to the longitudinal axis of the first hole 101 is approximately between 0-60 degrees. In one embodiment, the angle of the longitudinal axis of the second hole 102 in one of a pair of second bodies 100c-d relative to the longitudinal axis of the second hole can be the same as the angle in the second first body 100c-d. In one embodiment, the angle of the longitudinal axis of the second hole 102 in one of a pair of second bodies 100c-d relative to the longitudinal axis of the second hole can be different from the angle in the second first body 100c-d.

[0085] Although the embodiments discussed and described above have thus far been directed to devices and methods for applying lateral forces to treat maxillary hypoplasia, the present invention recognizes that one or more embodiments may be used to apply an anterior distraction force to treat maxillary hypoplasia.

[0086] In the above embodiments, it has been determined that a pair of second bodies 151a-b or third bodies 170a-b can be coupled to a pair of first bodies 100a-b, wherein in one embodiment, the holes 197 in the pair of third bodies 170a-b are configured to couple to the spring wire 196 (see Fig.10b ), the spring wire 196 is used to maintain the lateral distance between the mid-jaw suture of the maxillary bone. As shown in the following embodiments, the second body and the third body can also be configured to include holes that can be connected to externally worn appliances in the oral cavity, such as an orthodontic face bow, which can be used to achieve forward movement and growth of the maxilla. In one embodiment, the appliance transmits one or more extraoral traction forces to the body that is installed intraorally on the patient's maxilla in a manner that does not cause downward and forward movement and growth of the maxilla, or equivalently only forward growth or a combination of forward and upward movement and growth.

[0087] Fig.17a -c is a schematic diagram of an orthodontic device consisting of a pair of third bodies and an external wearing appliance connected to the pair of bodies. Fig.17a ), a pair of third bodies 2170a-b are connected via a pair of intermediate first bodies 2100a-b (not shown because they are Fig.17a In one embodiment, each of the pair of third bodies 2170a-b is configured to mate with each free end (denoted as 2002a-d) of the utensil 2002. In one embodiment, the mate is achieved by inserting the free convex end of the utensil into the recessed hole 2197 of the pair of third bodies. In an embodiment, the mate can be maintained by fasteners, interference fits, snap fits, slip fits and / or other releasable connections formed between the pair of third bodies 2170a-b and the free ends of the utensil 2002. In some embodiments, the hole 2197 enables the utensil 2002 to be simply and quickly connected to and removed from the pair of first bodies 2100a-b. In some embodiments, the utensil 2002 is made of one or more stainless steel, ceramic, cobalt-chromium alloy or other sufficiently strong material.

[0088] In another embodiment, a pair of second bodies 2151a-b are coupled to the hard palate via the middle first body 2100a-b. In one embodiment, each of the pair of second bodies 2151a-b is configured to mate with each free end of the device 2002. In an embodiment, the mate may be maintained by a fastener, an interference fit, a snap fit, a sliding fit, or a releasable connection formed between the pair of second bodies 2150a-b and the free ends of the device 2002. In one embodiment, the mate is achieved by inserting the free convex end of the device 2002 into a recessed hole 2197 formed in the second body.

[0089] Fig.18 21 is a schematic diagram of a pair of first bodies coupled to an externally worn device. In one embodiment, rather than coupling the device 2002 to the second body 2151a-b or the third body 2170a-b, the device is coupled to the pair of first bodies 2100a-b via fasteners 2198 provided to or in the first body. In one embodiment, the first body 2100a-b includes a hole similar to the hole 2197 described above.

[0090] Back to Fig.17a In one embodiment, the device 2002 includes two first portions 2002a configured to extend laterally from each free end to behind each of the patient's most posterior teeth (e.g., molars), and after extending beyond the posterior teeth, the two first portions 2002a are configured to be connected to a third portion 2002c by a curved portion 2002b, wherein the third portion 2002c is configured to extend from the curved portion generally along the opposite outer surfaces of the patient's teeth to the outside of the patient's mouth, and outside the patient's mouth, the two third portions 2002 are configured to be joined together in the form of an integral or non-integral fourth portion 2002d or directly. In another embodiment, instead of extending laterally behind the distal teeth, the first portions 2002a can be configured to be shaped so that they can be inserted into existing tooth gaps. In other embodiments, the shape of one or more portions of the device 2002a is customized to match the patient's specific geometry.

[0091] Fig.19a -b is a schematic diagram of other externally worn orthodontic appliances. In one embodiment, the appliance 2002 includes a fifth portion 2002e. In one embodiment, the fifth portion is coupled to the fourth portion 2002d in a direction generally orthogonal and upward relative to the fourth portion and extends from the center thereof. In one embodiment, the fifth portion 2002e is rigidly coupled to the fourth portion 2002d, for example, by brazing, welding, or other fixed coupling mechanisms known to those skilled in the art. In one embodiment, the fifth portion 2002e is configured to have two branches that extend upward from the fourth portion 2002d and recombine above the fourth portion 2002d, the two recombined branches forming a hole and extending to a terminal end. In one embodiment, the fifth portion 2002e includes at least one in the form of a hook, a loop (see Fig.19a ), depression (see Fig.19b ) or other attachment mechanism of the force point 2002n, from the elastic part or other external force part of the external wear traction frame or device can be connected to the attachment mechanism. In one embodiment, the fifth portion 2002e is configured to extend upward so that little or no interference is caused to the patient's nose during use.

[0092] Fig.20a -b is a schematic diagram of an external force applied to an externally worn device. As determined by the inventors of the present invention, when an external traction force is transmitted to the device and transmitted through the device to a pair of bone fixtures mounted on the maxilla, the application of a forward or forward and upward force can be used to achieve only forward growth, or forward and upward growth, wherein such force does not produce or minimally produces a rotational torque on the attachment point of the maxillary fixture. The present invention determines that when a forward or forward and upward traction force is applied to the device connected to a pair of bodies of the maxillary hard palate, and the rotational torque of the pair of first bodies 2100a=b connected to the maxilla is eliminated or minimized, upward or generally upward movement and growth of the maxilla can also be achieved. The present invention determines that when the device and a pair of bodies (e.g., see points A, B and / or C) connected to the maxilla (e.g., hard palate) are applied in a direction passing through the force application point on the device (e.g., see points A, B and / or C), the rotational torque of the first body 2100a=b connected to the maxilla is eliminated or minimized. Fig.20a When an extra-oral force is applied to the first body 2100a-b) in the device, the rotational torque transmitted to the pair of bodies and the maxillary bone can be minimized or eliminated. In one embodiment, referring to a patient standing with his head forward, when a force of 1588gm is applied to the device along an axis at an angle of 60 degrees to the horizontal and through a force application point "C" on the device and a force application point "D" on a pair of first bodies, the patient's maxillary bone can achieve the desired forward-only growth and movement. Other forces, angles, and other positions on the device are also within the scope of the present invention, depending on the patient's specific bone geometry and / or the specific desired distance of movement or growth of the patient's maxilla, as long as the direction of the force applied to the device is aligned according to the above-described embodiments and the pair of bodies. For example, as Fig.20b As shown, traction can be applied to the fifth portion 2002e at other locations 2002n, as long as the direction of force application generally passes through the pair of first bodies from the middle and passes through the force application point on the tool.

[0093] Fig.21a -b is a schematic diagram of another externally worn orthodontic appliance and its use. In one embodiment, each third portion 2002c of the appliance 2002 extends generally along the relative outer surfaces of the patient's teeth and is formed by an intraoral portion 2002p and an intraoral / extraoral portion 2002q connected to the intraoral portion 2002p by a releasable joint 2002f, for example, by a releasable joint formed by a hook, loop, snap fit, slip fit, interference fit and / or other similar interlocking members formed at the ends of the intraoral and oral / extraoral portions. In one embodiment, when the appliance 2002 is used intraorally, the intraoral / extraoral portion can be separated from the intraoral portion by the releasable joint 2002f as needed or desired (for example, when it is not desired to wear an external appliance in public). Although Fig.21a-b shows an apparatus having a connector 2002f on each side and connected thereto, it being understood that in other embodiments the apparatus may include more connectors and therefore more releasable portions than the apparatus shown.

[0094] Therefore, when the paired first body 2100a-b, the second body 2151a-b or the third body 2170a-b is used simultaneously with the orthodontic appliance 2002, in addition to the lateral expansion and growth of the maxilla, it is also determined that the forward or forward and upward movement and growth of the patient's maxilla can be achieved. In an embodiment using the third body 2170a-b, it is further determined that in addition to the bilateral movement and growth of the maxilla, unilateral movement and growth can also be achieved. It is also determined that the use of the first body 2100a-b, the second body 2151a-b and the third body 2170a-b eliminates the need to perform invasive surgical procedures such as those required by other devices. It is further determined that various aspects of the present invention are very suitable for the use of an externally worn device while the patient is sleeping, because it can be constructed into a shape that is only located thereon and passes through the patient's frontal facial anatomical structure, thereby minimizing the impact on side sleeping.

[0095] The foregoing embodiments have been described in detail to facilitate understanding, and the described embodiments should be considered illustrative rather than restrictive. It will be apparent to one of ordinary skill in the art that certain changes and modifications may be made within the scope of the appended claims.

[0096] For example, one or more features from any embodiment may be combined with one or more features of any other embodiment without departing from the scope of the present disclosure. In addition, any embodiment may be modified, added or deleted without departing from the scope of the present disclosure. In addition, other sizes and other materials other than the disclosed sizes and materials may be used, as long as they are compatible and strong enough to be used on a person. Moreover, although the described embodiments of the present invention can be used without the need to connect teeth or molar bands, it should be understood that the use of bands is not excluded, and if desired, the present invention can be modified to be used with bands. In addition, although the described embodiments of the present invention are used as orthodontic appliances to treat oral orthodontic conditions, their uses are much greater, such as as medical devices to treat non-obese obstructive sleep apnea caused by maxillary hypoplasia, or used in conjunction with other surgical procedures that can be performed by craniomaxillofacial surgeons, which can be covered by medical insurance, not just dental insurance.

Claims

1. A maxillary expander, comprising: at least two bodies (100a-b or 2100a-b), wherein each of the at least two bodies (100a-b or 2100a-b) is configured to be coupled to a hard palate, with a first distance between the at least two bodies (100a-b or 2100a-b) and a soft palate; and An aligner (106, 150 or 2001) comprising an expander (152, 162 or 172) configured to maintain a second distance between the at least two bodies (100a-b or 2100a-b), wherein the aligner (106, 150 or 2001) is configured to be coupled to and detached from the at least two bodies (100a-b or 2100a-b) when the at least two bodies (100a-b or 2100a-b) are coupled to the hard palate.

2. The maxillary expander according to claim 1, comprising: (i) a first body (100a-b or 2100a-b) having a plurality of first holes (101) and a plurality of second holes (102) arranged along a longitudinal axis of each first body, (ii) a first fastener (110) comprising a screw configured to be received through the fourth hole (198) and threaded into the second hole (102), and (iii) a plurality of threadably connectable second fasteners (111) configured to couple each first body to the hard palate by being inserted into the first hole (101), and wherein the aligner is an adjustable aligner (150), comprising (a) a second body (151a-b or 2151a-b) having a fourth hole (198) configured to receive a first fastener (110), and (b) where: The expander is an adjustment mechanism (152, 162 or 172) coupled to the second body (151a-b or 2151a-b) and configured to move the second bodies (151a-b) toward or away from each other.

3. The maxillary expander according to claim 1, comprising: (i) a first body (100a-b or 2100a-b) having a plurality of first holes (101) and a plurality of second holes (102) arranged along the longitudinal axis of each first body, (ii) a first fastener (110) comprising a screw configured to be received through the third hole (199) and threaded into the second hole (102), and (iii) a plurality of threadably connectable second fasteners (111) configured to couple each first body to the hard palate by being inserted into the first holes (101), wherein the aligner is a fixed aligner (106) having a third hole (199) configured to receive the first fasteners (110).

4. The maxillary expander according to claim 2, wherein: Each first body (100a-b) includes three first holes (101) and two second holes (102), and Each second body (151a-b) includes two fourth holes (198); wherein the fourth holes (198) are longitudinally spaced apart to match the longitudinal spacing between the second holes (102) of each first body (100a-b).

5. The maxillary expander of claim 3, wherein the fixed aligner (106) comprises four third holes (199).

6. The maxillary expander of claim 2 or 4, wherein the adjustment mechanism (152, 162, 172) is configured to rotate relative to the second body (151a-b or 2151a-b) so that the second bodies (151a-b or 215a-b) move toward or away from each other.

7. A maxillary expander as claimed in any one of claims 2 to 6, wherein the hole is a countersunk hole.

8. The maxillary expander as claimed in any one of claims 2 to 7, wherein the first hole (101) comprises a channel, wherein the channel is sunk into the first body (100a-b) to a first depth less than the thickness of the first body, and the channel is threaded along the first depth and is configured to threadably receive the threaded upper end of the second fastener (111) during the process of screwing the threaded bottom end of the second fastener into the palate.

9. The maxillary expander of claim 1, wherein the aligner is a fixed aligner (2001) comprising an alignment feature (2117) configured to receive a pair of first bodies (2100a-b) and a plurality of holes (2119) configured to receive a plurality of fasteners, the plurality of fasteners comprising a first fastener (2116) and a second fastener (2111).

10. The maxillary expander of any one of claims 2, 4, or 6-8, wherein the adjustment mechanism comprises a retractable expansion screw mechanism (172).

11. The maxillary expander of any one of claims 2, 4, 6-8 or 10, wherein the adjustment mechanism (162) comprises a unidirectional expansion screw, wherein one end of the unidirectional expansion screw is threaded and the other end is not.

12. The maxillary expander of claim 1, wherein the at least two bodies (100a-b or 2100a-b) are a pair of bodies, and a plurality of holes (101) are formed in each of the pair of bodies (100 ab or 2100 ab); and further comprising a plurality of fasteners (111) configured to fasten each of the pair of bodies (100a-b or 2100a-b) to the hard palate by inserting the plurality of fasteners (111) into the plurality of holes (101).

13. The maxillary expander of claim 12, wherein each of the first pair of bodies (100a-b or 2100a-b) comprises three holes (101) configured to receive fasteners (111).

14. The maxillary expander of claim 1, wherein the aligner is an adjustable aligner (150) comprising at least one body configured to be attached to the at least two bodies (100a-b or 2100a-b), and wherein the adjustable aligner (150) is configured to be releasably fastened to the pair of first bodies (100a-b or 2100a-b) to change a first distance between the first pair of bodies (100 ab or 2100 ab) by applying an expansion force to the first pair of bodies (100a-b or 2100a-b).

15. The maxillary expander of any one of claims 2, 4, 6-8, or 10, wherein the adjustment mechanism (152, 162, or 172) is configured to cause lateral movement of the hard palate.

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