Palate dilator and method for dilating palate

Abstract

Palatal dilator devices ("palatal dilators") for dilating the palate of a patient and methods of using and manufacturing these palatal dilator devices. The palate dilators may be configured to have a variable surface smoothness on one side (e.g., a lingual-facing surface) compared to an opposite side (e.g., a palate-facing surface). The palate dilators may be configured to have varying thicknesses at the palate region. These palate dilators may be adapted to be easily removed by a patient or caregiver (e.g., including an articulation region and / or detachment region, and / or including a thinner buccal side, then an occlusal side, and the like).

Description

[0001] This application is a divisional application of the invention patent application of Alleyne Technologies Co., Ltd. (the filing date of the divisional application is October 15, 2021, the application number is 202111205008.8, and the name of the invention is "Palatine expander and method for expanding the palate"). The above-mentioned invention patent application is a divisional application of the invention patent application of Alleyne Technologies Co., Ltd. (the filing date is December 4, 2017, the application number is 201780074928.6, and the name of the invention is "Palatine expander and method for expanding the palate").

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This patent application claims priority to U.S. Provisional Patent Application No. 62 / 429,692, filed on December 2, 2016, entitled “METHODS OFFABRICATING PALATAL EXPANDERS,” and U.S. Provisional Patent Application No. 62 / 542,750, filed on August 8, 2017, entitled “PALATAL EXPANDERS AND METHODS OF EXPANDING APALATE,” the entire contents of each of the above applications are incorporated herein by reference.

[0004] This application may be related to US2016 / 0081768 (titled “ARCH EXPANDING APPLICANCE”) and US2016 / 0081769 (titled “ARCH ADJUSTMENT APPLIANCE”), the entire contents of each of which are incorporated herein by reference.

[0005] Incorporation by reference

[0006] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0007] Palatal expanders, methods of making palatal expanders, and methods of using palatal expanders are described herein. For example, described herein are a series of palatal expanders that are sequenced to provide incremental palatal expansion (including rapid or gradual palatal expansion), and methods of making a series of palatal expanders customized for a patient. Background Art

[0008] A variety of orthodontic problems are associated with a narrow palate. In some cases, the maxilla is sized to accommodate the upper teeth. In other cases, there is room for the upper teeth but the palate is so narrow that pronunciation is impaired or becomes difficult. In other cases, the palate is so high that the amount of air that can pass through the nose is reduced, making it almost impossible to take a deep breath without opening the mouth. In all of these cases, palatal expansion (i.e., spreading the maxilla) may help.

[0009] Described herein are palate expander devices and methods that can be used to easily and effectively expand a patient's palate. Summary of the invention

[0010] Apparatus (including devices and systems) and methods for gradually expanding a patient's palate may include one or a series of palatal expanders. Methods and apparatus (including systems and devices) for progressive palatal expansion are provided herein. These palatal expanders may be adapted to be comfortable, effective and / or easy to remove. For example, described herein is a system for palatal expansion that may include a series of incremental expanders, the series of incremental expanders including: a first incremental expander having a geometry selected for expanding the palate; one or more intermediate expanders having a geometry selected for gradually expanding the palate to a target desired width. These systems may also include: a template for positioning one or more attachments for maintaining the palatal expander on the teeth of a subject; and / or a retainer or retainer for maintaining the expanded palate after active treatment.

[0011] Generally, expanders have been described as pre-formed devices having: a first molar engagement region adapted to engage upper molars on a first side of the upper jaw; a second molar engagement region adapted to engage upper molars on a second side of the upper jaw; and a palatal region, the geometry of which is selected to fit the shape of the palate while providing pressure to gradually expand the palate. Each expander in a series of expanders may include two molar regions, one on each side, each molar region having one or more cavities, each cavity adapted to fit over one of the patient's molars. In a particularly preferred embodiment, each molar region includes two cavities such that each molar region fits over two posterior molars or premolars. Each expander may also include a palatal region that separates the two molar regions and fits the patient's palate. Typically, the distance between the molar regions in a series of expanders increases sequentially.

[0012] The palatal region of the device can provide a force to stretch or expand the mid-palatal region. While energy-enhancing features (e.g., springs and thermally active materials) can be placed in this region, the region can also include one or more adapters, such as posts, supports, beams, ribs, gaps / windows, attachments, etc., which can distribute the applied force in a more subtle manner than previously described. For example, these devices can be constructed so that the applied force is distributed in a predetermined and / or desired pattern by arranging one or more contact points between the palatal expander and the patient's mouth (e.g., in the gums and / or preferably along the upper or lower lateral portions of the patient's teeth, including their molars). The curvature (e.g., concavity) of the device can also be adjusted to distribute the applied force while allowing clearance between the palate and the device, and / or allowing clearance for the user's tongue.

[0013] A series of palatal expanders as described herein can be constructed to expand the patient's palate by a predetermined distance (e.g., the distance between the molar regions of one expander may differ from the distance between the molar regions of the previous expander by no more than 2 mm, between 0.1 mm and 2 mm, between 0.25 mm and 1 mm, etc.) and / or by a predetermined force (e.g., limiting the applied force to less than 180 Newtons (N), between 8N-200N, between 8N-90N, between 8N-80N, between 8N-70N, between 8N-60N, between 8N-50N, between 8N-40N, between 8N-30N, between 30N-60N, between 30N-70N, between 40N-60N, between 40N-70N, between 60N-200N, between 70N-180N, between 70N-160N, etc., including any ranges therebetween).

[0014] In any of the devices described herein (and methods of making the same), the expander may be formed of a polymer (e.g., acrylic, thermoplastic, thermoset, etc.) and / or a metallic material (including stainless steel, nickel titanium, copper nickel titanium, etc.). Any of these devices may be formed by 3D printing and / or by a lamination process, wherein the device is formed of layers of material that may be formed and / or adhered together (e.g., to form a single device); different layers may have different mechanical and / or chemical properties and may include different thicknesses or thickness regions. For example, a device may include laminated materials bonded together.

[0015] Also described herein are devices and methods of forming these devices by direct manufacturing techniques. For example, devices (including a series of palatal expanders) can be digitally designed and manufactured by direct printing (e.g., 3D printing); alternatively or additionally, the manufacturing method can include 3D printing of a model of the teeth, gums, and palate that has been digitally constructed to form one or more series of applied palatal expansions.

[0016] Also described herein is a method of expanding a patient's palate using any of the devices described herein, which method may include: positioning each expander in a series of expanders in an appropriate position to expand the palate; maintaining the expander in the appropriate position for a period of time and replacing the expander with the next expander in the series until the desired palatal expansion occurs; and then applying a palatal expander configured to maintain the palate in a final position at a target desired width.

[0017] Any device described herein may be suitable for removing a palatal expander without reducing the holding force or ability of the palatal expander to remain in the patient's proper position. For example, any of these palatal expanders may include a disengagement area located on one or both buccal sides of the palatal expander. The disengagement area (which may be referred to as a removal handle, a removal cavity, a removal handle, a removal attachment, a removal slot, etc.) may include a gap, a slot, an opening, etc. on the upper or lower side, which may be suitable for allowing a user to insert a nail and / or a removal tool therein to remove the palatal expander from the teeth. The disengagement area may be configured to deform the palatal expander and release it from the patient's teeth. The disengagement area may be configured as a lip, a flange, or a protrusion on the buccal side of the palatal expander. Any of these palatal expanders may include a hinged area located between the occlusal surface and the buccal side, so that the operation of the disengagement area can pull the buccal side of the palatal expander away from the patient's teeth and / or disengage any attachments, so that the palatal expander can be removed. Any of these palatal expanders may include a slit, a slot, a gap, etc., which extends upward from the edge of the palatal expander toward the occlusal surface on the buccal side, allowing all or a portion of the palatal expander to be pulled upward and disengaged from the teeth.

[0018] Also described herein is a palatal expander that is adapted to be comfortable with varying thicknesses. For example, in any of these variations, the palatal expander may include an inner bottom surface in the palatal arch portion of the palatal expander that faces the patient's tongue when worn, the inner bottom surface being smooth or flat compared to an opposing surface that matches the patient's palate when the palatal expander is worn. This tongue-facing side may have a rounded surface and may not include any rapid transitions in topography compared to the patient's actual palate. In any of these examples, the device described herein may have different (including varying) thicknesses. In some variations, the device may include a narrower palate region toward the front of the palatal expander device. In any of these variations, the front portion of the palatal expander may be thinner and / or cut (removed) from the palatal expander, which may prevent or limit vomiting.

[0019] Any of the palatal expanders described herein may also or alternatively include an occlusal thickness that can be customized by a dental professional and / or may differ from the patient's normal occlusal topography. For example, the exposed occlusal surface of the palatal expander can be configured to have a surface configured to mate with the occlusal surface of the opposing jaw (e.g., the mandibular arch) when worn to apply force to adjust the patient's jaw position when worn. Alternatively or additionally, the thickness of the occlusal surface can be flatter, or can include a bevel or other structure to adjust the patient's bite. In some variations, the occlusal surface can be thinner or at least partially removed to minimize interference with the patient's bite. In some variations, the occlusal surface of the retainer can be thin or partially (or completely) removed, while in a series of palatal expanders used to actively expand the patient's palate, the occlusal surface can be thicker.

[0020] Also described herein are palatal expanders that are marked on a flat surface (e.g., a surface on the back or posterior edge of the palatal expander device) with a code indicating one or more of a serial number (e.g., first, second, third, fourth, etc. cage, etc.), a patient code (e.g., identifying a patient by a feature), a time and / or date, a copy number, etc. The identification code or part number can be configured such that it can be read by a user (e.g., a patient) to assist in performing palatal expansion in the proper sequence, as well as distinguishing between palatal expanders and cages.

[0021] Also described herein are methods for forming one or a series of palatal expanders and methods of making and using the same, wherein the palatal expanders are configured to include one or more gaps or spacing areas between the patient's upper arch and the upper (e.g., palate-facing) surface of the palatal expander. For example, any of these devices can be configured to include a gap or concave channel or area to prevent impact near the gum line (e.g., on the buccal and / or lingual side of the device). Any of these devices can be configured to include a gap between the upper (e.g., palate-facing) surface of the palatal expander and the palate.

[0022] Also described are methods and apparatus for palatal expansion using any of these devices.For example, described herein are methods for scanning the oral cavity of a patient, particularly including the upper arch, sufficiently so that the apparatus described herein for the palatal expander device can be formed.

[0023] Methods of applying or attaching the palatal expander described herein are described, including methods of a patient applying the palatal expander to her / his own teeth. Also described herein are attachments (which may alternatively be referred to as retaining attachments, retaining posts, etc.) and templates for attaching the attachment to the patient's teeth, which attachments may be configured to releasably secure the palatal expander to the patient's teeth. Methods of forming attachment templates and / or attaching attachments to teeth are also described.

[0024] Also described herein are methods and apparatus for removing a palatal expander from a patient's teeth.For example, described herein are removal tools for assisting a person (and in particular, but not limited to, a patient) in removing a palatal expander when the palatal expander is secured to the patient's teeth.

[0025] Also described herein are methods of making any of the devices described herein.

[0026] For example, a palatal expander device for expanding a patient's palate is described herein. The palatal expander device may include: a pair of tooth engagement regions connected by a palatal region and two or more attachment regions, each attachment region being configured to couple to an attachment coupled to the patient's teeth, wherein the palatal region is configured to apply a force between 8N and 160N between the pair of tooth engagement regions when worn by the patient; wherein each tooth engagement region includes an occlusal side and a buccal side, and wherein the occlusal side is thinner than the palatal region, and the buccal side is thinner than the occlusal side.

[0027] The thickness of the palatal region can be between about 1 mm and 5 mm (e.g., a thickness between 1.5 mm and 3 mm, between 2 mm and 2.5 mm, etc.). The thickness of the occlusal side can be between about 0.5 mm and 2 mm (e.g., between 0.5 mm and 1.75 mm, between 0.75 mm and 1.7 mm, etc.). The thickness of the buccal side can be between about 0.25 mm and 1 mm (e.g., between 0.35 mm and 0.85 mm, between about 0.4 mm and 0.8 mm, etc.).

[0028] Any of these devices may include a hinge (eg, a hinge region) on the buccal side or between the buccal and occlusal sides configured to allow bending at the hinge, which may make removal of the device easier.

[0029] Any of these devices may include a visible identification mark on the flat posterior surface of the palatal expander device, wherein the identification mark encodes one or more of the following: a patient number, a revision indicator, an indicator whether the device is a palatal expander or retainer, and a treatment stage.

[0030] Any of these devices may include a breakaway area located on the buccal side of the device to assist in removing the device after the device is attached to the patient's teeth. Since the force applied to widen the palate may make it difficult to easily remove the device, a breakaway area (e.g., a notch, a gap, a handle, a tab, a slot, etc.) located on the buccal side may be used to more easily remove the device from the teeth, particularly when the device is fixed to the teeth using an attachment. The breakaway area may be located on or extend from the buccal side and may be spaced at least 0.25 mm to 1 mm from the patient's gums when the device is worn and may be close to the bottom edge of the buccal side of the device (or extend from the bottom edge, or above the bottom edge). For example, the bottom edge of the buccal side may be configured as a breakaway area extending from the buccal side of the device along all or one side of the buccal area (e.g., between 1 mm and 5 cm, such as 1 mm to 4 cm, 1 mm to 3 cm, 5 mm to 4 cm, etc.). The extension may be configured to extend below the patient's gums and away from the patient's gums, such as to form a gap between about 0.25 mm and 1 mm when the patient wears the device. Any of these devices may comprise one or more vertical slots or slits extending from the bottom of the buccal side towards the occlusal side. In particular, these slots or slits may be located on either side of the detachment area.

[0031] Any of these devices can be smooth on the tongue-facing side of the device. For example, the palatal region can include an upper convex surface having a first surface curvature, the upper convex surface including a plurality of grooves and ridges that align with grooves and ridges in the patient's palate; and wherein the palatal region includes a lower concave surface having a second surface curvature that is smoother than the first surface curvature. Smoother can mean having fewer and / or lesser degrees (deep, high) of grooves and / or ridges.

[0032] Also described herein is a method of making a palatal expander device, the method comprising: receiving a model (e.g., a digital model, a manual model, etc.) of a patient's upper arch; and forming a palatal expander having a pair of tooth engagement regions connected by a palatal region and two or more attachment regions, each attachment region being configured to couple to an attachment coupled to the patient's teeth; wherein each tooth engagement region is configured to fit on the patient's teeth, and each tooth engagement region includes an occlusal side and a buccal side; further, the occlusal side includes a breakaway region, the breakaway region being configured to engage with the patient's nail to break away at least one of the attachment regions from the attachment on the patient's teeth. Forming the device may include: forming any of the features described herein, including the breakaway region, the slit / slot; smoothing the lingual-facing side; forming an opening in the device; varying the thickness of different regions relative to each other and / or within each region, etc. For example, forming may include forming the palatal region by smoothing a bottom surface of the palatal region relative to an opposing top surface of the palatal region.

[0033] For example, a method of manufacturing a palatal expander device may include: receiving a model of a patient's upper arch; forming a palatal expander having a pair of tooth engagement areas, the pair of tooth engagement areas being connected by a palatal area and two or more attachment areas, each attachment area being configured to couple to an attachment coupled to the patient's teeth; wherein each tooth engagement area is configured to fit on the patient's teeth, and each tooth engagement area includes an occlusal side and a buccal side; and the disengagement area on the buccal side has a gap, configured to engage with the patient's nail or an elongated tool and disengage at least one of the attachment areas from the attachment on the patient's teeth.

[0034] In any of these methods and devices, the breakaway region may include a protrusion extending from the buccal side of the tooth engagement region. The palatal expander may be configured to not contact either or both of the gums adjacent to the lingual side of the patient's teeth and the midline of the patient's palate when worn by the patient.

[0035] In any of these methods, the tooth engagement region may include an extension on the buccal side of the tooth engagement region that extends from the patient's gums to form a gap of approximately 0.25 mm to 1 mm when the device is worn by the patient. The tooth engagement region may include a protrusion extending from the buccal side of the tooth engagement region. The palatal expander may be configured to contact the lingual side of the patient's teeth when worn by the patient and apply a force between 8N and 160N between the tooth engagement region. The palatal expander may be configured not to contact either or both of the gums adjacent to the lingual side of the patient's teeth and the midline of the patient's palate when worn by the patient.

[0036] The device may be formed in any suitable manner, including by three-dimensional (3D) printing.For example, receiving a model of the patient's upper arch may include receiving a digital model of the patient's teeth, gums, and palate area.

[0037] Any of these methods may also include forming a retainer and / or forming a template for placing an attachment. Any of these methods may also include sending and / or providing these devices to a dental provider and / or patient.

[0038] The present invention also describes a palatal expander device for expanding a patient's palate, comprising: a pair of tooth engagement regions connected by a palatal region and two or more attachment regions, each attachment region being configured to couple to an attachment coupled to the patient's teeth; wherein each of the tooth engagement regions comprises an occlusal side and a buccal side, and wherein at least one of the occlusal sides comprises a disengagement region located on the buccal side, the disengagement region being configured to be grasped and pulled to disengage at least one of the attachment regions from an attachment located on the patient's teeth.

[0039] A palatal expander device for expanding a patient's palate may include: a pair of tooth engagement regions connected by a palatal region and two or more attachment regions, each attachment region being configured to couple to an attachment coupled to the patient's teeth; wherein each tooth engagement region includes an occlusal side and a buccal side, and wherein the occlusal side is thinner than the palatal region, and the buccal side is thinner than the occlusal side; and an articulation region, on the buccal side, located anterior to the occlusal side.

[0040] For example, a palatal expander device (and series or sequences of palatal expanders) is described herein; any of which may be removable by the patient or a patient caregiver. For example, a palatal expander device for expanding a patient's palate may include: a pair of tooth engagement regions connected by a palatal region, wherein the palatal region is configured to apply a force between 8N and 160N between the pair of tooth engagement regions when the patient wears the device; wherein each tooth engagement region includes an occlusal side and a buccal side, and wherein the occlusal side is thinner than the palatal region, and the buccal side is thinner than the occlusal side.

[0041] In general, any of these palatal expanders can be configured such that all or a portion (e.g., a mid-palatal region, e.g., configured to be positioned relative to a suture) is spaced a minimum distance from the patient's palate when the device is worn, e.g., between 0.01 mm and 5 mm (e.g., 0.02 mm or greater, 0.03 mm or greater, 0.04 mm or greater, greater than 0.05 mm or greater, 0.06 mm or greater, 0.07 mm or greater, 0.1 mm or greater, 0.15 mm or greater, 0.2 mm or greater, 0.25 mm or greater, etc.). This minimum distance can be determined when the palatal expander (including the palatal region) is formed by modeling the patient's dental arch (e.g., from a digital model). Including this minimum distance may be particularly helpful, for example, to prevent pain or irritation of the soft and / or hard palate when wearing one or more palatal expanders.

[0042] This space between the palatal-facing surface of the palatal region of the palatal expander and the patient's palate can be referred to as a gap. This spacing can be positive (e.g., forming a gap) or can be negative in some areas of the palatal region, such as impinging on the patient's palate to provide a force for expanding the palate. Negative gaps can be identified by comparing an actual or predicted (e.g., for later stages of expansion treatment) model of the patient's palate to the outer (palatal-facing) surface of the palatal expander. The actual or early model can be a digital (virtual) or cast of the patient's dental arch. In later stages of treatment, the gap can be estimated from a digital model where the patient's palatal region morphology is predicted by deforming the palatal region r to reflect the progress of treatment.

[0043] For example, by including a positive gap greater than a certain minimum value (e.g., see above, such as 0.1 mm, 0.2 mm, etc.) in an area constructed to be worn opposite the soft palate area, contact with the soft palate area of ​​the patient's palate can be avoided. Typically, any of these devices can be constructed so that the mid-palate area (e.g., opposite the middle palatal suture) deviates from the patient's palate when worn. In some variations, the separation distance can be maximum in the mid-palate area. In some variations, the separation distance can decrease laterally, and a negative gap (e.g., force contact) can exist laterally. The gap can vary over a sequence or series of aligners. For example, an initial (early) stage can be constructed to have a lower maximum positive gap than a later stage, which can have a larger maximum gap. For any of these devices, the rear portion can have a larger positive gap than the front portion. In some variations, the maximum positive gap can taper from the maximum value in the mid-palate area toward the teeth.

[0044] For example, in some variations, the palate region may be configured to have a gap greater than 0.1 mm from the patient's mid-palate region when the patient wears the device.

[0045] Any of these devices may include two or more attachment areas, each attachment area being configured to couple to an attachment coupled to a patient's teeth. The attachment areas may be openings, recesses, slots, channels, etc., for securing to an attachment coupled to a patient's teeth. The attachment areas may be configured to secure to a patient's teeth, but allow the device to be removed from the attachment by flexing a portion of the palatal expander (e.g., a breakaway area), which may be on the buccal side, including extending from the buccal side.

[0046] Typically, as described above, any of the palatal expanders described herein may include a variable thickness (e.g., a lateral thickness perpendicular between opposing upper and lower surfaces). For example, the average and / or maximum thickness of the palatal region may be greater than the average or maximum thickness of the occlusal surface (e.g., the side that is worn against the occlusal surface of the teeth); the average or maximum thickness of the buccal surface (e.g., the side that is worn against the buccal surface of the teeth) may be less than the average or maximum thickness of the occlusal surface and / or the palatal surface. Alternatively or additionally, in some variations, all or a portion of the occlusal surface may be resected. Typically, the anterior portion of the palatal region may have an average thickness that is different from the posterior portion of the palatal region. For example, the anterior portion of the palatal region may be thinner than the posterior portion of the palatal region; alternatively, the anterior portion of the palatal expander may be thicker than the posterior portion.

[0047] As described above, any of these devices may include an articulation region on the buccal side or between the buccal and occlusal sides that is configured to flex and release the tooth engagement region from the patient's teeth. The articulation region may be a localized region where the thickness and / or stiffness of the palatal expander is less than nearby adjacent regions such that when a force is applied, for example, pulling on the buccal distal edge of the palatal expander, the articulation region will preferentially flex so that the attachment region can be disengaged from attachment on the patient's teeth.

[0048] Generally, any device described herein may include a visible identification mark on a surface of the palatal expander device, including but not limited to a posterior edge or surface, wherein the identification mark encodes one or more of: a patient number, a revision indicator, an indicator that the device is a palatal expander or retainer, and a treatment stage.

[0049] As described above, any of these devices may include an extension extending from the buccal side of the device, wherein the extension is configured to extend adjacent to and away from the patient's gums when the patient wears the device to form a gap between about 0.25 mm and 1 mm. The length of the extension may be determined so that it does not contact the inner buccal surface.

[0050] Any of these devices may include a palatal region having: an upper convex surface (surface facing the palate) having a first surface curvature; and a concave (tongue / lingual facing) surface having a second surface curvature that is smoother than the first surface curvature. Thus, the thickness of the palatal region can span different portions of the palatal region. In some variations, as described herein, the upper convex surface may have a first surface curvature comprising a plurality of grooves and ridges corresponding to grooves and ridges in the patient's palate (although they may be positively / negatively offset from them when worn, as discussed above). The concave surface may have a second surface curvature that is smoother than the first surface curvature.

[0051] For example, a palatal expander device for expanding a patient's palate may include: a pair of tooth engagement regions connected by a palatal region, wherein the palatal region is configured to apply a force between 8N and 160N between the pair of tooth engagement regions when the patient wears the device; and an extension extending from the buccal side, wherein the extension is configured to extend adjacent to and away from the patient's gums to form a gap between approximately 0.25mm and 1mm when the patient wears the device; wherein each tooth engagement region includes an occlusal side and a buccal side, and wherein the occlusal side is thinner than the palatal region, and the buccal side is thinner than the occlusal side, and wherein the palatal region is configured to have a gap greater than 0.1mm from the patient's mid-palatal region when the patient wears the device.

[0052] A palatal expander device for expanding a patient's palate may include: a pair of tooth engagement regions configured to be attached to the patient's molars, wherein the tooth engagement regions are connected by a palatal region, the palatal region being configured to apply a force between 8N and 160N between the pair of tooth engagement regions when the patient wears the device; and wherein each tooth engagement region includes an occlusal side and a buccal side, and wherein the occlusal side is thinner than the palatal region, and the buccal side is thinner and more flexible than the occlusal side; and wherein the palatal region includes an upper convex surface having a first surface topography; and wherein the palatal region includes a lower concave surface, the lower concave surface having a second surface topography that is smoother than the first surface topography.

[0053] The topography of the upper or lower surface of a palatal expander may refer to the surface contour. The smoothness of the topography may refer to the relative rate of change of surface height along the surface; smoother surfaces generally have a greater rate of change in height than less smooth surfaces. Smoothness may be the average or overall smoothness of all or multiple regions of a surface.

[0054] Typically, the first surface topography (e.g., the topography of the surface facing the palate) can be configured to increase the structural integrity of the palatal region and provide a force between 8N and 160N between a pair of tooth engagement regions when the device is worn by the patient. For example, the first surface topography can include a plurality of grooves and ridges configured to correspond to grooves and ridges of the patient's palate. Alternatively or additionally, having the first surface topography correspond to a surface of the patient's palate can allow the palatal expander to be more comfortably and / or more closely positioned on or adjacent to (but offset from) the palatal expander than would otherwise be possible, compared to a surface topography having a greater lingual void for an equivalent thickness of the palatal region.

[0055] In some variations, the first surface topography includes one or more lengths of increased thickness of the palatal region extending between the tooth engagement regions. For example, the palatal expander may include one or more full or partial struts extending laterally between the tooth engagement regions. In some variations, the first surface topography includes one or more lengths of increased thickness of the palatal region extending from the front to the back.

[0056] For example, a palatal expander device for expanding a patient's palate may include: a pair of tooth engagement regions connected by a palatal region and two or more attachment regions, each attachment region being configured to couple to an attachment coupled to the patient's teeth; wherein each tooth engagement region includes an occlusal side and a buccal side, and wherein at least one of the buccal sides includes a disengagement region, the disengagement region being configured to flex to disengage at least one of the attachment regions from the attachment on the patient's teeth.

[0057] A palatal expander device for expanding a patient's palate may include: a pair of tooth engagement regions connected by a palatal region and two or more attachment regions, each attachment region being configured to couple to an attachment coupled to the patient's teeth; wherein each tooth engagement region includes an occlusal side and a buccal side, and wherein the occlusal side is thinner than the palatal region, and the buccal side is thinner than the occlusal side; and an articulation region on the buccal side or between the buccal side and the occlusal side, configured to bend to disengage at least one of the attachment regions from an attachment on the patient's teeth.

[0058] Also described herein are palatal expander systems for expanding the patient's palate. These systems may include any of the palatal expanders described herein. Thus, systems including any of these devices (and series of these devices) are described herein. For example, a palatal expander system for expanding the patient's palate is described herein, the system comprising: a template for positioning a plurality of attachments on the patient's teeth; a plurality of attachments configured to be retained in the template; and a plurality of palatal expanders forming a series of gradually increasing widths. In some variations, each palatal expander comprises a pair of tooth engagement regions connected by a palatal region and two or more attachment regions, each attachment region being configured to be coupled to one of the attachments, wherein the palatal region is configured to apply a force between 8N and 160N between the pair of tooth engagement regions when worn by the patient, and wherein each tooth engagement region comprises an occlusal side and a buccal side, and wherein the occlusal side is thinner than the palatal region, and the buccal side is thinner than the occlusal side. Each of the plurality of palatal expanders may include a detachment region located on the buccal side of at least one of the attachment regions, wherein the detachment region is configured to be grasped and pulled to detach at least one of the attachment regions from the attachment on the patient's teeth.

[0059] A system may include: a template for positioning a plurality of attachments on a patient's teeth; a plurality of attachments configured to be retained in the template; a plurality of palatal expanders forming a series of gradually increasing widths, wherein each palatal expander includes a pair of tooth engagement regions connected by a palatal region and two or more attachment regions, each attachment region configured to couple to one of the attachments, wherein the palatal region is configured to apply a force between 8N and 160N between the pair of tooth engagement regions when worn by the patient, and wherein each tooth engagement region includes an occlusal side and a buccal side, and wherein the occlusal side is thinner than the palatal region, and the buccal side is thinner than the occlusal side; wherein each of the plurality of palatal expanders includes a breakaway region located on the buccal side of at least one of the attachment regions, wherein the breakaway region is configured to bend to disengage at least one of the attachment regions from the attachment on the patient's teeth.

[0060] The present invention also describes a method for expanding a patient's palate using a series of patient-removable palatal expanders, the method comprising: sequentially wearing each of a plurality of palatal expanders in a predetermined order of increasing widths, except for the last palatal expander from the series of patient-removable palatal expanders, wherein: each palatal expander comprises a pair of tooth engagement regions connected by a palatal region and two or more attachment regions, wherein the tooth engagement regions are worn on the patient's teeth and the attachment regions are connected to attachments on the patient's teeth, wherein the palatal region applies a force between 8N and 160N between the pair of tooth engagement regions when worn by the patient, and wherein each tooth engagement region comprises an occlusal side and a buccal side; each palatal expander is worn for between 0.5 days and 14 days; and each palatal expander is removed by pulling a detachment region on the buccal side extending at least 0.25 mm from the patient's gums to detach at least one of the attachment regions from the attachment on the patient's teeth; and the retainer palatal expander corresponding to the last palatal expander is worn for more than 14 days. The phrase "wearing the palatal expander for ... days" generally does not require continuous (e.g., uninterrupted) wearing, but can include removing the palatal expander for routine cleaning (e.g., disinfection of the device, washing of the device, brushing teeth, etc.). Thus, wearing the device can include removing the device for less than a certain percentage (e.g., 2%, 5%, 7%, 10%, etc.) of the time period (e.g., a few minutes to an hour in a day, etc.). BRIEF DESCRIPTION OF THE DRAWINGS

[0061] The novel features of the invention are particularly set forth in the claims that follow. A better understanding of the features and advantages of the invention will be obtained by referring to the following detailed description and the accompanying drawings, which set forth illustrative embodiments utilizing the principles of the invention, wherein:

[0062] Figure 1A-1G An example of a palatal expander is shown that may be part of a series of palatal expanders for expanding the palate of a patient. Figure 1A is a front perspective view of the bottom side (tongue-facing side) of the palatal expander, shown attached to a model of the patient's upper dental arch. Figure 1B yes Figure 1A Rear stereoscopic view of the palatal expander. Figure 1C yes Figure 1A Another posterior stereoscopic view of the palatal expander. Figure 1D yes Figure 1A Anterior and lateral stereoscopic view of the palatal expander. Figure 1E yes Figure 1A Side stereoscopic view of a palatal expander. Figure 1F yes Figure 1A Another posterior stereoscopic view of the palatal expander. Figure 1G yes Figure 1ATop perspective view of a palatal expander showing the tooth receiving cavity and the top surface facing the palate.

[0063] Figure 2A-2C A system for expanding a patient's palate is shown, including an accessory template (in Figure 2A ), a series of progressive palatal expanders ( Figure 2B ) and a passive cage (e.g., Figure 2C The retainer shown in FIG.

[0064] Figure 3 A method of treating a patient to expand the patient's palate using the palate expander described herein is shown.

[0065] Figure 4A A translational force (arrow) is shown that may be applied to the patient's palate to expand the palate, immobilize, and separate the midline palatal sutures (eg, mid-palatal suture, etc.). Figure 4B A series of palatal expanders are shown that are configured to gradually expand the sutures (e.g., Figure 4B The expanders shown in may be examples taken from a complete sequence of, for example, 8 or more expanders, and do not necessarily represent three expanders in direct sequence).

[0066] Figure 4C An example of a palatal expander is shown in which a portion of the palatal region has been removed from the anterior region; similarly, other regions of the device may be removed, for example, from the posterior region. Alternatively or additionally, any of these devices may have hole cutouts in other regions, including in the central region.

[0067] Figure 5A is used to attach accessories (shown as Figure 5B An example of a template applied to the appropriate area of ​​the tooth to cooperate with the palatal expander so that the palatal expander will remain in the correct position on the tooth. Figure 5B Two attachments are shown attached to the patient's teeth in predetermined positions; in this example, four attachments may be used to secure each palatal expander to the tooth during treatment.

[0068] Figure 6 is an example of a retainer (eg, a passive expander or retainer).

[0069] Fig. 7A is an example of a palatal expander that includes a breakaway region (e.g., a removal handle or tab) and two or more lateral articulation regions (e.g., slots, cutouts, slits, curved regions, etc.) extending from a lateral edge (e.g., a buccal edge) toward the occlusal surface that can be used to assist in removing the device from the subject's mouth.

[0070] Figure 7BA cross-section is shown through a portion of a palatal expander configured to include a breakaway region wherein an outer (e.g., buccal) edge of the palatal expander forms a gap separating it from the teeth and / or gums and is sized and configured such that a patient's fingernail and / or a removal device can be inserted to pull the device off the teeth, including from attachments to the teeth.

[0071] Fig. 8A An example of a palatal expander sectioned through the xy (sagittal) plane is shown, (in Figure 8B Middle) shows regions of different thickness. Figure 8B and Figure 8C The thickness of the transverse palatal, occlusal, and buccal segments are shown. Figure 8B , an articulation region between the occlusal region and the buccal end of the palatal expander is shown which preferably bends when a force is applied to pull the buccal segment (e.g., a breakaway region on the buccal segment) to pull the device away from the tooth.

[0072] Fig.9A Another example of a palatal expander having a cross section through the xy plane is shown. Fig. 8A shown. Fig. 9B The transverse palatal region of a palatal expander in the xy plane is shown, showing the different thicknesses (TH) perpendicular to the palatal-facing side of the device.

[0073] Fig. 10A is an example of a palatal expander with a cross section through the zy plane (midline cross section). Fig. 10B Shows Fig. 10A Example of a cross-section of a palatal expander in the zygomatic plane of FIG, showing the thickness of the palatal expander through the posterior end (posterior facet) and the anterior end (anterior facet).

[0074] Fig.11A is an example of a palatal expander having another portion that passes through the zy plane away from the midline of the palatal expander. Fig. 11B Shown by Fig.11A Cross section of the palatal expander in the zygomatic plane. Fig. 11C is a 3D model of the palatal expander, with a cross section like Fig.11A and Fig. 11B shown.

[0075] Fig.12 One example of an identification or part number marked on a palatal expander is shown (shown on a flat surface formed on the posterior end of the palatal expander). The identification marking may include a serial identifier / number (e.g., indicating the number of the palatal expander in a series), a patient-related identifier / number, etc. The identification marking may be printed large and clear enough so that the patient can read it.

[0076] Fig.13A is a cross-sectional view of a palatal expander showing the clearance areas that may be included; specifically, the clearance area between the palatal expander and the upper arch, including a concave channel or area anterior to the lingual surface of the palatal expander to prevent gingival impingement, and the clearance between the soft tissue and palatal areas.

[0077] as Figure 7B , Fig. 13B Shown is a cross section through a portion of a palatal expander including an edge region that may include a gap and / or may serve as a removal tab (or a portion of a removal tab) for removing the palatal expander. Fig. 13C is another alternative portion through a portion of a palatal expander that includes a removal tab area that creates a gap between the buccal end / edge of the palatal expander and the patient's gums and / or teeth.

[0078] Fig.14A is an example of a portion of a patient's palatal surface showing an area of ​​a channel having a relatively sharp curvature. The palatal expander can be formed such that the thickness of the palatal expander over the central palate spanning area can be smoothed to eliminate the sharp curvature in the surface, making the surface smooth, such as Fig. 14B shown. Fig. 14C Contour plots comparing the original palatal surface to the smooth surface are shown, as well as the composite final surface that includes some ridges / channels but has them smoothed.

[0079] Fig.15 is an example of a tool that can be used to remove a palatal expander and includes a proximal handle region and a distal palatal expander engagement region.

[0080] Fig.16A is an example of a bottom view of the upper palate showing attachments that may be made for some or all of the teeth in various locations in order to secure the palatal expander to the subject's teeth.

[0081] Fig. 16B is an example of a bottom view of a palatal expander.

[0082] Figure 17A-17E The attachments on the patient's dental model are shown. Fig.17A In the side perspective view of the subject's teeth, the attachments are shown. These attachments can be generally cross-section, truncated and cross-section cylindrical attachments for holding the palatal expander on the teeth. Four attachments are included in this example (two on each side). Fig. 17B is a side perspective view of the attachment and tooth, showing the pitch angle of the top surface of the attachment. Fig. 17C is a side view of the tooth and attachment, showing the global angulation angle (the angle between the base of the attachment and the tooth (or the median plane through the tooth)). Fig.17DThe projection of the attachment is shown (eg, the distance the attachment extends from the tooth surface). Figure 17 is another side perspective view showing the distance from the gum to the attachment on the tooth. Figure 17A-17E The dimensions shown in are exemplary and approximate only; these distances may be + / - 5%, 10%, 15%, 20%, 30%, 40%, 50%, etc.

[0083] Fig.18A and Fig.18B A guide for scanning the upper arch of a patient to form a series of palatal expanders is shown, as described herein. Fig.18A In , the scan includes at least 2-3 cm beyond the distal edge of the permanent molars; in Fig.18B This distance is missing from the scan.

[0084] Fig.19A and Fig.19B An exemplary guide for scanning a patient's dental arch is shown, including sufficient space (e.g., 3×3 mm) to scan the sides of the patient's molars. Fig.19A In the scan, at least 3 × 3 mm of the side wall; Fig.19B In the example, a square area smaller than 3×3 is digitally scanned.

[0085] Fig. 20A and Fig. 20B Additional exemplary guidance for scanning the patient's upper dental arch is shown. Fig. 20A In the gingival area, at least 5 mm is below the cementoenamel junction (CEJ) line. Fig. 20B A scan is shown that does not include as much gingival area (particularly in the posterior areas, such as around the molars).

[0086] Figure 21A-Figure 21C A method of inserting a palatal expander 2100 into a patient's teeth is shown, comprising: placing the device on the upper dental arch in the patient's mouth ( Fig.21A ) and bite the palatal expander device ( Fig. 21B and Fig. 21C ) to position and secure the device to the tooth, including, in some examples, securing to the attachment.

[0087] Figure 22A-22C The detachment area ( Fig.22A ), pull cheekward away from the teeth ( Fig. 22B ) to disengage any attachments, then pull down ( Fig. 22C ) to remove the palatal expander device including the detachment area from the tooth removal device.

[0088] Fig.23 An example of a palatal expander is shown that includes a sealing attachment that can help maintain it within the oral cavity.

[0089] Fig.24 is an example of a palatal expander with opening attachments for retention and force application.

[0090] Fig.25 An example of a palatal expander is shown, including an opening attachment and a cutout area (shown here as a slit in the opening attachment).

[0091] Fig.26 is another example of a device comprising a slit connected to an open attachment in the expander, showing the attachment (pin) coupled to a model of the patient's teeth.

[0092] Fig. 27 is an example of an expander having an opening attachment that is positioned away from the edge of the device (e.g., by moving the bottom edge or cutting line closer to the gum or by moving the opening further up the tooth).

[0093] Fig.28 An example of the device of FIG. 5 is shown including a cutout area that may enhance flexibility and / or ease of application.

[0094] Fig.29 is an example of a dilator that includes a cutout area (shown here as a slit) that is not connected to the opening.

[0095] Figures 30A-30H Various examples of openings and cutout areas between an expander and a patient's tooth or an attachment on a patient's tooth (eg, a connection between a patient's tooth and an expander appliance) and attachments are shown, including openings having different sizes and / or shapes.

[0096] Figure 30I-Figure 30N Further examples of openings, incision areas, and attachments to a patient's teeth (eg, connections between a patient's teeth and an expander appliance) are shown.

[0097] Fig.31A and Fig.31B A portion of a palatal expander is shown that includes a plurality of openings to connect to attachments on a patient's teeth; in this example, the openings of the expander initially include attachments to be coupled to the patient's teeth, the attachments being connected by one or more tabs that can be separated, broken or removed so that the tabs remain on the patient's teeth. This may be useful for properly attaching the connector attachment to the patient's teeth. Fig.31B Shown along Fig.31A The section along line AA in .

[0098] Fig.32is another example of an expander that includes an attachment that may be included as part of the expander (shown here as a separate element retained within the opening of the palatal expander) for application to the teeth as a guide or template.

[0099] Fig.33A A method of forming a palatal expander as described herein using a stamping process is shown; Fig.33B An enlarged detail of a palatal expander formed using this method is shown.

[0100] Fig.34A A method of forming a palatal expander as described herein using a rolling (spring roller) process is shown. Fig.34B are examples of general spring rolling processes that can be used.

[0101] Fig.35 A method of forming a palatal expander as described herein using a casting process is shown.

[0102] Fig.36 is another example of a method of using a curing mask to form a palatal expander as described herein.

[0103] Fig.37 A method of forming a palatal expander as described herein using a CNC (computer numerical control) roller is shown.

[0104] Fig.38 A method of forming a palatal expander as described herein using a deposited adhesive and a mask is shown.

[0105] Fig.39 A method of using an LCD mask to form a palatal expander as described herein is shown.

[0106] Fig.40 A method of forming a palatal expander as described herein using injection molding (eg, expander top and bottom injection molds are shown).

[0107] Fig.41 is an example of a method of forming a palatal expander by a heat dispensing ("thermal graffiti") method.

[0108] Fig.42 A method of forming a palatal expander as described herein using blow molding is shown.

[0109] Fig.43 A general method of forming a palatal expander as described herein by deposition is shown.

[0110] Fig.44 is an example of a palatal expander formed by applying a reinforcing material (referred to herein as a "scraper" method).

[0111] Fig.45A method of forming a palatal expander as described herein using pressure forming is shown.

[0112] Fig.46 is an example of a direct manufacturing method of forming a palatal expander as described herein by injection molding.

[0113] Fig.47 is another example of a direct manufacturing method to form a palatal expander as described herein.

[0114] Fig.48A and Fig.48B Another example of a method of forming a palatal expander as described above is shown, wherein the expander includes a mechanical interlock / latch.

[0115] Fig.49A and Fig.49B Another example of a method of forming a palatal expander as described herein by injection molding (insert injection molding) is shown.

[0116] Fig.50 A lamination manufacturing process for forming a palatal expander is shown; Fig.40 In this method, a single laminate layer is used.

[0117] Fig.51 An example of a lamination method using two lamination layers is shown.

[0118] Fig.52 An example of a lamination method using a lamination packaging method is shown.

[0119] Fig.53 is an example of a lamination method using laser welding to form a palatal expander.

[0120] Fig.54 is an example of a method of forming a palatal expander by lamination using separate regions (eg, separate crowns).

[0121] Fig.55 A method of forming a laminated palatal expander using standard thermoformed materials for TPA (transverse palatal arch) is shown.

[0122] Fig.56 is an example of a general manufacturing process using a standard shape (eg, a "standard universal shape").

[0123] Fig.57 is an example of a palatal expander that includes a magnet.

[0124] Fig.58 is an example of a palatal expander that uses multiple snap-fit ​​elements.

[0125] Fig.59is an example of a palatal expander that includes folds (an "origami" design).

[0126] Fig.60 An example of a palatal expander is shown that includes an extension region to aid in removing the device from the patient. DETAILED DESCRIPTION

[0127] Typically, the palatal expansion devices described herein are worn by the patient as a series of expanders. These palatal expanders can be configured to apply force within the patient's mouth to expand the patient's maxilla. The patient can be any suitable patient, particularly a child between 7 and 9 years old (e.g., after the first permanent molars have erupted). These devices can be used to expand the patient's palate by 4 mm to 12 mm or more. In use, a series of palatal expanders can be applied and / or removed by the patient (or a caregiver, such as a parent), and can be adapted to be securely attached to the patient's teeth, have sufficient strength to move the patient's teeth, and can be removed without excessive force or difficulty (e.g., using fingers and / or tools to remove). The device can be attached to the patient's last three teeth (e.g., the first permanent molars and the first and second deciduous molars). Typically, the device should be strong enough to generate sufficient force to open the patient's bone joints, for example, applying a force between 8N and 120N (or greater than 8N, greater than 9N, greater than 10N, greater than 20N, greater than 30N, greater than 40N, greater than 50N, greater than 60N, etc.) against the sides of the upper palate and / or the lingual side of the teeth.

[0128] In any of the devices and methods described herein, the device can be configured so that it (with or without being connected to an attachment that is coupled to the patient's teeth) can be securely attached to the patient's teeth while still being easily removable by the patient and / or a caregiver. For example, the buccal side of the device can be flexible, for example, by being thinner than the occlusal and palatal regions, and / or by including an articulation region that is configured to be pulled away from the tooth and / or attachment on the tooth to disengage the device. In some variations, the device may include a slot or slit on either side of the attachment mating region that extends upward from the bottom edge of the device. In some variations, the device may include an articulation region located between the buccal side and the occlusal side (or on the buccal side above the attachment mating region).

[0129] Any device described herein can be configured so that the convex surface of the palatal region matches the patient's palate (e.g., including any grooves, ridges, valleys, etc. present in the patient's specific anatomy). The convex surface can match the patient's palate, but can be configured to be separated or offset from the patient's palate by, for example, 0.5 mm or more, particularly in areas that are more central (e.g., opposite the midline suture of the palate). In some variations, the device can be offset from the patient's palate, and the force can be applied primarily against the lingual side of the teeth (e.g., molars); alternatively or in addition, the device can be configured to apply force to the lateral area of ​​the palate above the molars; in this case, the convex surface of the palatal region can be configured to have a negative offset, for example, to push against the palate when worn.

[0130] The bottom concave surface of the palate region may have a different surface profile compared to the upper surface. In particular, it may be more comfortable if the device has a bottom concave surface that is smoother than the upper surface. For example, the bottom concave surface facing the patient's tongue may be free of grooves, ridges and / or valleys that are present on the opposing upper surface. Alternatively, the bottom concave surface may be substantially free of perceptible bumps, lumps or depressions. In some variations, the bottom concave surface may be considered to be a filtered version of the top convex surface opposite the bottom surface; the bottom surface is smoothed (e.g., by a smoothing function) compared to the opposing top surface to avoid any sharp changes in the surface due to, for example, grooves, ridges, etc. Smoothing the bottom surface in this manner can improve patient comfort while avoiding pronunciation problems.

[0131] The palatal expanders described herein can be formed from a single piece of material (e.g., by 3D printing technology, etc.), or they can be partially formed, such as by layering, thermal curing, etc. The device (e.g., apparatus, system, etc.) can have a variable thickness (particularly in the palate region and / or tooth receiving portion). For example, the palate region can be thinner in a more anterior region (e.g., the front half) than in a more posterior region (e.g., the back half). This can allow for a more comfortable fit, leaving room for the patient's tongue. Alternatively, the back half of the device can be thinner than the front half. The back portion can be curved inward (e.g., toward the front region), or a cutout region can be included in the back end.

[0132] In particular, palatal expansion devices and methods of using these palatal expansion devices (applying them, removing them, treating a patient to expand the patient's palate, etc.) and methods of forming these palatal expansion devices are described herein. These devices can be configured to apply a "slow" expansion (e.g., a force of approximately 8N-10N between the molars on either side of the upper jaw of the oral cavity), or a "fast" expansion (e.g., a force greater than approximately 60N for higher speed expansion, including forces between 70N-160N, etc.). In some variations, the devices can be configured to drive displacement and / or force. For example, any of these devices can be configured to drive a displacement of between approximately 0.25mm / day (when worn for a 24-hour wear time). These devices (e.g., devices) can form a series of devices that can be used to move the palate, expand the palate, and generate lateral forces between the molars on both sides of the oral cavity.

[0133] Any of the palatal expander devices described herein may include a gap or offset between the upper surface of the oral cavity (palatal surface) and the palatal expander. The offset may be, for example, between 0.1 mm and 10 mm (e.g., between 0.2 mm and 9 mm, between 0.3 mm and 9 mm, between 0.5 mm and 8 mm, between 1 mm and 7 mm, between 2 mm and 5 mm, etc., including any area or sub-area therebetween). The gap may prevent soft tissue irritation. When worn by the patient, the gap may extend over more than 50% (e.g., more than 60%, more than 70%, more than 80%, more than 90%, more than 95%, etc.) of the portion of the device opposite the patient's palate. In some variations, the shape of the palatal portion of the expander (e.g., the portion opposite the patient's palate when worn by the subject) may be contoured on the side facing the patient to match the contour of the patient's palate (with or without an offset, as described above).

[0134] As will be described in more detail below, the shape of the device (e.g., expander) can be controlled and selected during the manufacturing process, and thereby the load applied by the device when worn. It may be particularly advantageous to provide a digital planning process in which a digital model of the patient's upper jaw (e.g., teeth, palate, and gums) and in some cases the subject's lower jaw (e.g., teeth and / or gums) can be modified to plan a series of expanders that deform between the patient's initial anatomical structure and an expanded configuration (where the final expanded configuration is described). Previous attempts to digitally design palatal expanders have been hampered by the inability to accurately model palatal expansion and tooth movement / position, and therefore the overall effects of the teeth and palate and the resulting forces applied to various parts of the patient's mouth have not been rigorously simulated. These attempts have also ignored the effects on the lower jaw, particularly the interaction between the lower jaw and the upper jaw. Excellent results can be achieved by accurate digital modeling of the teeth, gums, and palate (and the lower jaw in some variations) and by controlling the designed movements (e.g., expansion of the palate, which can be represented as separation between molars) and the forces acting on one or more teeth, palate, and / or gums. Additionally, the expanders may also be digitally modeled, including modeling of the shape (size, including thickness, curvature, attachment points, etc.) and materials used. Thus, one or more expanders in a series of expanders may be accurately and in some cases automatically configured so that they achieve the desired palatal expansion within predetermined (or user / physician / technician) adjustable parameters, such as the expansion force applied (e.g., between x and yN, less than yN, etc., where x is approximately 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, etc., and y is approximately 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, etc.), the location in the patient's mouth where the force is applied (e.g., the upper portion of the molars, the middle portion of the molars, the lower portion of the molars, the gums, the palate, etc.), and / or the portion of the patient's mouth to avoid contact (e.g., the gums, the palate, the middle palate, the lateral palate, etc.).

[0135] Dilator Features

[0136] The palatal expander described herein may include a tooth engagement region for engaging at least a portion of the teeth (particularly the molars) in the patient's upper jaw, and a palatal region extending between the tooth engagement regions, the palatal region being configured to be positioned adjacent to and opposite the patient's palate when the patient wears the device. For example, Fig.23An example of a palatal expander 100 is shown that includes a pair of tooth engagement regions 103, 103' on either side of the device connected by a palatal region 105. In this example, the palatal expander also includes a pair of attachment regions (attachment coupling regions) 107 that can be coupled to a pair of attachments (e.g., attachment connectors) that are coupled to the patient's teeth on either side of the device (on the buccal side of the patient's teeth; only one pair is visible). The attachment connectors may also be referred to herein as connectors, pins, attachments, etc., and may be secured to the teeth at a position that allows them to be coupled (e.g., removably coupled) to the attachment regions on the expander. The attachment connectors may be bonded (glued, etc.) to the teeth as part of an initial step prior to wearing a series of expanders. In Fig.23 , the bottom concave surface 108 is shown; the opposite surface is the top convex surface.

[0137] The tooth engagement region may be formed of the same material as the palatal region, or they may include different materials. The thickness of the tooth engagement region and the palatal region may be different or the same. In particular, the palatal region may be thicker than the tooth engagement region. The thickness of the tooth engagement region may be thicker along the sides of the device (e.g., buccal and / or lingual) and thinner on all or a portion of the top of the tooth engagement region (or removed from all or a portion of the top of the tooth engagement region). The palatal region may have an uneven thickness. For example, a palatal expander may be thicker near the midline of the device. Any palatal expander may include ribs or other supports (e.g., extending laterally between and / or perpendicular to the tooth engagement region). These ribs may be formed of the same material as the rest of the palatal region (e.g., but thicker and / or shaped to have a cylindrical cross-sectional profile).

[0138] The inner (cavity) portion of the tooth engagement area is typically constructed to conform to the outer contour of the patient's teeth and directly abuts against a portion of the teeth and / or gums (or avoids the gums) to apply pressure thereto. The upper surface of the palate area positioned adjacent to the palate when worn by the patient can be contoured to match the actual or predicted shape of the patient's palate. As described above, all or most of the palate area can be separated or spaced apart from the patient's palate when worn, which can enhance comfort and minimize disruption to pronunciation.

[0139] In some variations, a portion of the palatal region extending between opposing tooth engagement areas on either side of the device (e.g., a portion of the palatal region extending approximately z% of the distance between the tooth engagement areas, where z is greater than approximately 30%, 40%, 50%, 60%, 70%, 80%, 90%, etc.) can be flat or straight, rather than curved, so that it does not necessarily follow the contour of the patient's mouth. This portion can be one or more transverse ribs, struts, or supports, or it can be a flat plate. Such a flat or straight portion can provide increased force. Alternatively or additionally, the palatal region (e.g., one or more ribs, plates, etc.) can be curved into an arc (which is similar to the arc of the patient's palate), but can have a larger radius of curvature than the patient's palate (appearing as a shallower concave surface).

[0140] Any palatal expander described herein may include one or more attachment areas or sites (also referred to herein as attachment openings, attachment couplers, etc.) for connecting to attachment connectors on the patient's teeth. In particular, it may be helpful to use one or more (e.g., a pair) of attachment areas on each side of the device. In addition, the attachment site may preferably be an opening through the expander. The open structure (attachment site) on the orthodontic expander can interact with the attachments (attachment connectors) located on the teeth to improve the overall retention of the appliance, and in some cases can be used to produce favorable force characteristics for tooth alignment, including limiting or preventing the teeth from shaking toward the cheek as the palate expands. In particular, these features may be helpful when included as part of a direct manufacturing (e.g., 3D printing) device for rapid (e.g., stage 1) palatal expansion. Figure 23-Figure 3 1 are examples of accessories (e.g., attachment connectors / attachment sites) that can be used as part of any expander. In addition, although the attachment connector is typically coupled to one or more teeth and protrudes into a complementary opening or cavity on the expander, the configuration can be reversed in some or all of these; for example, a protruding attachment connector can be a part of the expander that can be inserted into an opening / cavity coupled to the user's teeth.

[0141] Any suitable attachment area may be used, and in particular, any suitable size and / or shape may be used. As described above, the attachment area may preferably be an open structure on the appliance that may improve the retention of the appliance on the attachment and may include force features for tooth alignment. For example, the attachment area may include a circular, oval, square, rectangular, triangular, etc. opening through the expander (e.g., on the side of the tooth restoration area of ​​the expander, such as the buccal side). The attachment area may be keyed relative to the attachment connector; typically, the attachment connector may be configured to mate with the attachment area in one or a specific orientation.

[0142] The open attachment area can reduce the non-compliance of the appliance to poorly cured accessories. The open structure can achieve complete coverage of predetermined accessory shapes and sizes. Any of these attachment area / attachment connector couplings can include biomechanical force characteristics of the appliance / attachment interaction, which includes a keyed area that transmits rotational forces in the plane of the opening (e.g., against the surface of the tooth) as described above. In some variations, the attachment connector can snap or couple into the attachment area in a manner that requires force to disengage the coupling.

[0143] like Fig.23 As shown, conventional appliance designs may include attachments that help maintain retention in the oral cavity. Fig.24 As shown, the variability in the size of these attachment areas due to device manufacturing (e.g., thermoforming, direct manufacturing, etc.) can be reduced by creating an open structure. Fig.24 The separator is very similar to Fig.23 The separator shown in FIG. 1 only includes two open attachment areas 117 .

[0144] In any of the devices described herein, the device may also include more than one cutout region, wherein the cutout region (e.g., slot, slit, etc.) opens to the side or edge of the device. Cutout features such as these can increase the flexibility of adjacent areas (e.g., cheek surfaces). When connected to or adjacent to an attachment region opening, such as Fig.25 As shown, this configuration can increase or decrease the retention of accessories. Fig.25 In FIG. 3 , a cut-out area (slit 305) has been added to the opening structure 307 to increase the flexibility of the device on the attachment.

[0145] Fig.26 Another example of a cutout area (slit) between openings (attachment areas) suitable for coupling with an attachment connector is shown. In this example, the attachment connector and the attachment area are connected to secure the expander 401 to (a model of) a patient's tooth 404.

[0146] exist Fig. 27 Another example of an expander with an attachment area including an opening through the expander on the buccal side is shown in FIG. The attachment area can be formed at any location of the expander, in particular on the buccal side including the tooth abutment area. Fig. 27 In the embodiment, the opening is arranged upward from the edge area on the buccal side of the tooth joint area so that the "cut line" located above or at the gum edge (when formed as a direct manufacturing part) has been lowered to increase the mechanical strength around the opening 307, thereby increasing retention.

[0147] Fig.28 Shows Fig. 27In the example of , slits 305 are added to increase the flexibility of the device at the edges (but not the palate area), which can make the device easier and faster to put on and / or remove. Fig.29 In the example, a slit is added between the openings to produce a Fig.28 Another dimension of different flexibility is shown. Fig.29 In the embodiment, the slit is located between two open attachment areas 30; Figure 6 As shown, alternative or additional slits (which generally extend perpendicular to the edge of the device) may be located on one or both sides of the opening and / or within the opening.

[0148] FIG. 30A to FIG. 30N Various examples of attachment sites are shown (not in order). In some variations, the attachment site is configured as a hook 803 (see Fig. 30B ), attached around the attachment connector 805 (e.g., a post, protrusion, etc. connected to the tooth 804). Alternatively, the attachment site can be a channel 807' ( Fig. 30C ) or keying area 807 ( Fig. 30A ) for engaging the attachment connector 805. Alternatively or additionally, the attachment site 809 on the palatal expander can be configured to snap onto the attachment connector 806 (e.g., Figure 30E-Figure 30H ), which can be tapered as it approaches the tooth surface. Any of the attachment connectors / attachment sites shown can be configured so that multiple attachment connectors 815 are coupled to one attachment site 813. In some examples, the attachment site and / or the attachment connector can be configured to allow adjustment / re-adjustment to tighten / loosen the connection. For example, multiple attachment connectors 817 (e.g., Figure 30M ) can be connected together in a manner that allows a user or patient to select which of the multiple attachment connectors to engage with one (or more) attachment sites 819. Alternatively or additionally, the device 821 may include multiple attachment sites 822, 822' (e.g., Fig.30N ), these attachment sites are oriented with slots / slits in different directions so that two or more attachment connectors 825 can be inserted and allow the device to apply torsional or other directional forces (rotation, etc.) to the tooth. Figures 30A to 30N As shown, extended open cell structures 813, 807 can exist between the attachment connectors, and / or the connection sites can be configured as double hook and single hook 803 systems. In the connection attachment, the connection area includes holes and slits, which can be modified so that the slits taper to increase retention. Examples of key and lock systems of different geometries are also shown. As described above, the attachment area can be positioned on the teeth alternatively, and the attachment connector can be located on the appliance. Any of these designs can be used to control the torque and force of tooth movement.

[0149] In variations where an attachment connector (e.g., a post) is incorporated into a patient's tooth, an exemplary expander may be used to attach the connector (which may be set as a "zero" expander in a sequence where the palate has not yet been expanded). The expander may be used as a template to position the attachment connector on the tooth, as shown in FIGS. 31 and 32. Fig.32 As shown. In Figure 31, one or more attachment connectors are included with a palatal expander 901, which can be used as a placement carrier (template). An attachment connector 907 can be printed with the expander (including an attachment area) so that one or more tabs 905 (e.g., removable, fragile, cuttable, etc. tabs) extend from an attachment area having an opening (hole) feature in the palatal expander 901 to the attachment connector. The tab in this example is a small tab or strip of material. After the attachment connector 707 is coupled to the tooth, the tab will be cut / removed. The tab is made of a material that is dissimilar to the palatal expander (or the same material), and / or the attachment connector 907 can be made of the same or different material as the expander and / or the tab. The attachment connector can be designed with a customized buccal profile to make the cheek fit more precise.

[0150] Fig.32 Another example of a device including an attachment area that is an opening or hole feature in a palatal expander 1001 is shown; this example can also be used as a bonding template for a preformed attachment connector 1005, which in this example is not attached to the expander / template by a tab. In this example, one or more attachment connectors can be manufactured separately (from another material and / or process, or from the same material and / or process), but the expander can include a customized connector area (hole feature) that includes a positioning feature to orient the attachment connector 1005 so that the patient's buccal contour is aligned. The attachment connector can be designed so that the buccal contour and the positioning feature are aligned for accurate placement.

[0151] Once a series of palatal expanders has been designed, including digitally (or in some variations, manually), the individual devices forming the series can be manufactured. Described herein are various manufacturing methods that can be used. Any of these manufacturing methods can be combined or modified to take into account other manufacturing methods or portions of these manufacturing methods. Different expanders in a patient series can be manufactured by the same method or by different methods.

[0152] Figure 1A-1GExamples of palatal expanders 150 shown from different perspectives are shown. These or similar palatal expanders may include any of the features described herein, either individually or collectively. In this example, the palatal expander is configured to be removable, e.g., removable by a patient (with or without a removal tool), and may be formed of any suitable material, including, for example, a biocompatible nylon material. Figure 1A-1G The example shown in is 3D printed. A series of palatal expanders can be used and gradually graded to expand the patient's palate. In particular, the methods and devices described herein can be configured for use in treating children and young adults. The palatal expander can be configured to balance the load offset of the transverse palatal arch region 152 for patient comfort. For example, the lateral force can be distributed on the three posterior teeth on each side, such as Figure 4A As shown, and / or distributed on the side of the palate. The thickness of the occlusal surface 154 can be optimized for structural integrity and patient comfort. The palatal expander device can include multiple attachments (in Figure 1A-Figure 1D The attachment may be configured to allow the device to be easily inserted and retained. As will be described in more detail herein, the palatal expander may also include one or more removal features to allow the patient to remove the device after it has been attached.

[0153] As mentioned above and in additional detail below, the force applied by the device to expand the patient's palate can be applied to the teeth evenly in the anterior-posterior direction (typically symmetrically on either side of the midline) or at different areas along the anterior-posterior direction (e.g., the lingual side of the D, E, or 6 teeth, as shown in FIG. Fig.16A ) and / or the palate, particularly the sides of the palate, above the gum line but below the midline.

[0154] In any of the palatal expanders described herein, an opening or hole formed through the palatal expander may be included. For example, in some variations, such areas of the palatal expander may be removed that would otherwise cover the occlusal surfaces of the patient's teeth. For example, allowing a more natural bite. In some variations, the front portion (front region) of the palatal region extending between the opposite sides of the upper arch (e.g., the opposite tooth receiving portions of the device) may be removed or bent inward to avoid interfering with pronunciation. Alternatively or additionally, the rear (e.g., dorsal) end of the palatal expander may be removed or bent forward to minimize or reduce the induction of a gag reflex. In any of these variations, the thickness may also be adjusted additionally or alternatively. For example, the thickness in the posterior region (e.g., dorsal 10%, 20%, 30%, etc.) of the palatal expander may be thinner than the more anterior region.

[0155] The apparatus described herein can be configured as a system comprising: an attachment and an attachment template for positioning the attachment on a tooth, a series of palatal expanders that gradually expand the patient's palate, and a passive retainer (e.g., a retainer) for wearing after the series of palatal expanders have expanded the palate. For example, Figure 2A-2C The components of such a system are shown. Figure 2A An example of an attachment template 251 is shown; multiple attachments ( Figure 2A ) can be attached to the patient's teeth at predetermined positions, which can correspond to the location of the receiving site on each palatal expander. Figure 2B An example of a series of gradually wider palatal expanders is shown. For example, the upper palatal expander 258 is narrower than the intermediate palatal expander 259 and the final palatal expander 260. Figure 2C An example of a passive retainer (e.g., retainer) 261 is shown that can be worn after the series of palatal expanders has completed the patient's palate expansion. In this example, the palatal expander retainer 261 is similar or identical to the last palatal expander in the sequence, although it can have a different configuration.

[0156] Any of the examples described herein may be constructed to include, for example: a breakaway area (e.g., removal tabs, slots, etc.) at the gingival margin gap and / or extension to aid in instrument removal; a palatal expander identification mark (e.g., an expander identification code), etc.

[0157] Figure 5A-Figure 5B An enlarged view of an attachment template and attachment is shown. In this example, the attachment can be placed on a patient's tooth, e.g. Figure 5B Two attachments 551, 552 are shown, one on the (crown center) molar of E and the other on the (mid-cusp) molar region of 6. The template can be fitted over the patient's teeth and the attachments (which can be preloaded into the template and / or applied through the template) can be bonded to the teeth. In this example, four attachments are used.

[0158] exist Figure 2B and Figure 4B In the exemplary active palatal expander shown in , the expander is configured for daily wear (e.g., 23-24 hours of wear). In these examples, the palatal expander can be configured to provide a predetermined amount of total arch width actuation per stage (e.g., about 0.15mm, 0.20mm, 0.25mm, etc.), which is similar to a spiral actuated expander.

[0159] The cage or retainer (e.g., Figure 2C and Figure 6) is provided to the patient to wear. For example, a pair of similar retainers (one for wearing and the other as a spare) can be provided. The retainer can be marked as described herein to indicate that it is a retainer. For example, one or both of the palatal expander and the retainer can be marked with an alphanumeric code (e.g., a nine-digit key) that can uniquely identify the device. For example, the nine-digit expander key can be "981WWXYZZ", where WW is a number 01 to 99 corresponding to the patient number, X is A to Z (corresponding to the edition), Y is E or H (expansion device or retaining device), and ZZ is a number between 01 and 99 corresponding to the treatment stage.

[0160] As mentioned above, Figure 2C and Figure 6 An example of a retainer is shown, such as a passive palatal expander. Generally, each of a series of palatal expanders may be worn for up to two weeks; similarly, a retainer may be worn for up to two weeks to retain the device. During treatment, a dental professional (e.g., a physician) may require a default or request at any stage in treatment for retention of the device. If the expansion goal is not achieved, the physician may request further expansion via a new scan, as described below.

[0161] Figure 3 An exemplary method for treating a patient to expand the patient's palate is shown. The first step shown may include identifying a patient in need of palatal expansion 351. The patient may be a child, adolescent, young adult, or adult. Once the patient is identified, the dental arch including the palate, teeth, and at least a portion of the gums may optionally be digitally scanned 353. Alternatively, the upper dental arch may be manually modeled (e.g., using a dental impression). When scanning is used, any suitable scanner may be used, including but not limited to an intraoral scanner that can directly scan the teeth, gums, and palate. Reference is made below to Figures 18A-20B The description is a guide for scanning a patient's upper arch so that an order for a palatal expander can be formed (including a template for placement of the attachment).

[0162] Once the upper arch has been modeled (e.g., scanned, manually modeled, etc.), a palatal expander may be designed 355. In general, these designs may be constructed to include any of the features described herein. The design process may include planning the final position of the teeth and / or palate, and designing an intermediate palatal expander to achieve the final configuration. The design process may include providing locations for attachments on the teeth to provide secure attachment and to move the teeth, and / or to prevent the teeth from tilting significantly during expansion. The design process may be performed digitally using a digital model of the patient's upper arch. The design process may be automated or semi-automated.

[0163] Once designed, a series of palatal expanders 357 can be manufactured, and the template can be manufactured at the same time. Any appropriate manufacturing technology can be used. For example, the method can include 3D printing and / or lamination. Examples of these methods are provided below. The manufactured palatal expander can then be sent to the patient and / or a dental professional 359, who can instruct the patient to apply and remove the palatal expander. The treatment can then optionally be monitored 361 to track palatal expansion, including periodic (e.g., daily, weekly, biweekly, etc.) scanning of all or a portion of the upper arch (palate, teeth, gums, etc.). The treatment can be adjusted to increase or decrease the rate of expansion, for example, by redesigning the series of palatal expanders and / or remanufacturing the palatal expander. Once the sequence of palatal expanders has been worn, the patient can then wear a retainer (e.g., a retainer) to prevent relapse of the palate; the retainer can be worn until the palatal sutures heal. The retainer can be provided to the patient along with a series of palatal expanders, or the retainer can (optionally) be sent to the patient 363 during or immediately after treatment.

[0164] As described above, any of these methods and apparatus may include a palatal expander having one or more removal / release features. Figures 7A-8C Examples of various removal / release features are shown that allow the palatal expander to be manually disengaged and removed from the teeth after the patient has applied the palatal expander. Fig. 7A In the example, the palatal expander includes a breakaway area (configured to remove the tab 751). The breakaway area in this example is a tab or protrusion extending along or near the bottom (e.g., bottom side) of the lateral (buccal) outer side of the palatal expander. The breakaway area 751 may include a slot or opening into which the patient's fingernail can be inserted to allow the buccal side of the palatal expander to be separated and pulled away from the teeth so that any one or more attachments on the palatal expander can be removed. The device can then be pulled off the teeth.

[0165] exist Fig. 7A In the embodiment of the present invention, the design also includes a pair (although one or more may be used) of slits, slots, cut-out areas, etc. 753, 753' extending upward from the bottom edge on the buccal side toward the occlusal surface. These slots, slits, etc. can provide an area for separating the palatal expander (particularly one or more attachments) from the teeth for removal. One or more slits on the outside of the attachment cavity of the device can allow for a lifting step to begin the removal process (e.g., a smaller edge length with a gap (as described below) can minimize food entrapment and can eliminate the need for gingival extension).

[0166] As described above, the design (size, shape, protrusion and position) of the attachments on the teeth and / or the device can be configured to facilitate insertion and still be highly retentive. Similarly, the disengagement (release) feature can be configured to allow retention until manually triggered by the patient to release.

[0167] Typically, any of these devices may include a hinged area (particularly in front of the occlusal surface) that allows bending to disengage the device from the teeth. For example, a finger-accessible hinge design may be included to allow the device to be disengaged from the retaining attachment for easier removal.

[0168] In some variations, the release mechanism may include a lock or other area that may need to be actuated (e.g., by deformation, squeezing, etc.) before it can be released. For example, the palatal expander may be squeezed or deformed (e.g., by first biting the palatal expander), followed by pulling the release on the palatal expander (e.g., using a fingernail) to release the appliance while also releasing the bite on the palatal expander. Thus, another portion of the device may be modified or deformed to begin disengaging the device from the retaining attachment.

[0169] Any of the devices described herein may include a release portion (e.g., a breakaway region) formed at least in part by a lip or flange that forms a finger gap that can be manipulated by a patient's finger (e.g., a nail). Figure 7B As shown in the cross-sectional view of , in some variations, the gap can be formed as an outwardly extending buccal edge of the device. Figure 7B in, and in Figure 13A-13C In the embodiment of the present invention, the gap or spacing between the palatal expander and the gums along all or part of the bottom of the palatal expander can be sized to allow the patient's finger / nail to engage the palatal expander and pull the palatal expander away from the palate. The palatal expander can include an extension 759 located at the bottom edge of the buccal side of the palatal expander. The extension can be specifically designed to leave a gap between the palatal expander and the gums, for example, up to the gum line 761. Better removal can be provided by the extension of the extension in the cheek below the gum line, and the separation between the gums and the palatal expander. See, e.g. Figure 13A-13B .

[0170] To provide sufficient mechanical advantage (or torque) to facilitate removal of the device, the extended region (eg, "finishing line") may extend 1 mm to 3 mm below the gum line, such as Figure 7B , Figure 13A-13B In this example, a gap 780 of between about 0.25 mm and 1 mm is provided between the extension and the gums to facilitate hooking of the patient's / parent's finger / nail to remove the palatal expander. Any of these examples may also include an articulation region that is thinner than other adjacent regions (e.g., the occlusal surface). For example, see Fig. 8A and Figure 8B.exist Fig. 8A , an exemplary palatal expander shows an xy plane passing through the palatal expander; Figure 8B A portion of the outline of the palatal expander in the xy plane is shown. Figure 8B In the embodiment, the palatal expander includes a central transverse palatal segment 851 located on either side of the midline of the device. Figure 4A As shown, the transverse palatal region can be configured as described herein to apply force to open the bone sutures of the palate when worn. The force can be applied to the lingual side of the teeth (e.g., molars) and / or to the sides of the palate. One or more sides of the transverse palatal segment can be configured to align with the lingual side of the teeth. The occlusal segment 851 can be positioned above the occlusal surface of the tooth. Finally, the buccal segment 852 can extend downward along the buccal side of the tooth and can include a release (e.g., a breakaway area) portion. Figure 8C Additional details are shown regarding the thickness of these different regions. For example, in this example, the transverse palatal segment may have a uniform thickness (or a nearly uniform thickness; this thickness may vary after smoothing the outer tongue-facing surface, as described in more detail below). The occlusal segment may have a different (e.g., smaller) uniform thickness, and may transition between the transverse palatal segment thickness and the occlusal segment thickness, either uniformly as a step or as a function.

[0171] Thus, in general, the thickness of the palatal expander in different areas can be adjusted to allow for different stiffness and expansion properties of the palatal expander. Fig. 9B In the example, the transverse palatal segment (also referred to as the palatal region) can be about 3 mm-4.5 mm thick in this example to provide a high level of hardness. The occlusal segment can have a thickness of about 1 mm-2 mm, which can be thick to obtain sufficient wear resistance and mechanical hardness due to biting and chewing. In this example, the buccal segment and buccal extensions have a thickness of about 0.75 mm (e.g., between about 0.25 mm and 1 mm), which can provide flexibility. The flexibility can decrease in three steps with thickness. In this example, the transition between the occlusal region and the buccal region can occur from the buccal cusp line to a lower height of about 0.75 mm, such as Figure 8C The transition between the transverse palatal region and the occlusal region occurs at the level of the gum line of the cheek up to the buccal cusp line.

[0172] The thickness and / or shape of the transverse palatal segment can be modified specifically to provide uniform hardness and / or location of force application across the palate, including to the lingual side of the teeth (e.g., teeth D, E, 6) or one or more regions of the palate, particularly including regions laterally offset from the midline of the palate. For example, finite element modeling of the thickness of the transverse palatal segment.

[0173] The thickness can be determined for any point on the bottom surface of the device (e.g., the bottom of the transverse palatal segment or region) by finding the minimum distance from the relative upper surface of the device (e.g., the same area of ​​the device). The effect of thickness on the force applied by the device can be estimated by modeling the transverse palatal segment as a curved beam. In this approximation, Castiglano's theorem (Castiglano's theorem, Castiglano's theorem of minimum function) can be used to estimate the force. The analysis can be simplified and can allow for estimation of force for any width, thickness, and radius of curvature. Compression extension can also be estimated. A desired hardness range (e.g., between 50N / mm-90N / mm, between 60N / mm-90N / mm, between 70N / mm-90N / mm, between 80N / mm-100N / mm, etc.) can be targeted. Thus, the stiffness can be equal to a compression force within a desired range (e.g., 8N between 0.15mm and 0.30mm, 9N between 0.15mm and 0.30mm, 10N between 0.15mm and 0.30mm, 15N between 0.15mm and 0.30mm, 20N between 0.15mm and 0.30mm, 25N between 0.15mm and 0.30mm, 30N between 0.15mm and 0.30mm, etc.), providing a target expansion for each stage (expandor) of wear. The material forming the expander can maintain approximately half (e.g., between 45%-60%, etc.) of its mechanical properties under stress relaxation when worn by a patient (e.g., at 37°C (when worn in a compressed state for a treatment period of, for example, 24 hours). For example, a minimum compression of 40N force (e.g., minimum 35N, minimum 40, minimum 45, etc.) between about 0.15mm and 0.30mm (e.g., between 0.20mm and 0.25mm, etc.) can be used as a design criterion.

[0174] Similarly, when the buccal side deflects under the removal force, the buccal side can be considered a cantilever beam. The thickness and height can be customized based on this modeling type.

[0175] As described above, in any of these variations, the buccal side of the device may include an extension extending from the buccal side that is configured to extend adjacent to and away from the patient's gums to form a gap (e.g., between about 0.2 mm and 2 mm, e.g., between 0.25 mm and 1 mm, etc.) when the device is worn by the patient. The patient or caregiver can use the extension to remove the device by separating the device from one or more attachments. Typically, removal of palatal extensions (particularly those having attachment areas that couple to attachments that are bonded to the teeth) may require significant force. The patient or caregiver may not be able to easily detach the device from the attachment. It is typically necessary for a force F to be applied perpendicular to the buccal side of the device, such as Fig.60Thus, the extension region 6001 can help detach any one or more of the attachments and remove the device. Specifically, the extension region 6001 (which can be a portion of the buccal side extending below the bottom of the attachment region (e.g., Fig.60 Lx in () can be designed to help the buccal region articulate around the tip line 6003 at the top of position x, where the buccal side becomes the occlusal side on the crown tip. As described above, this portion of the device can "articulate" around this line, causing it to act similarly to a cantilever beam. The deflection when a force F is applied at any position at any distance from the fixed line of the cantilever beam can be estimated from the geometry of the device (including the size and location of the attachment site). For example, if the height of the attachment is 1.25mm (e.g., y=1.25mm), and x is the distance from the tip line to the top of the attachment, when the attachment is located in the middle of the buccal side (e.g., x=1 / 2L), the force required for disengagement can be estimated and (F) can be set to approximately the same amount of force that a typical user's finger can apply. Given the boundaries of x (upper and lower) and this typical range of forces (F) from a user's finger, when the attachment height is constant, the length of the buccal side can be estimated, for example, from the gingival edge (e.g., 2mm below the gingival side). Therefore, the length of the extension area 6001 can be estimated. For typical forces to remove the device, the length can be between 1 mm and 5 mm, for example, between 2 mm and 4 mm, etc. The length can be adjusted to avoid contact with soft tissue. The amount of force (F) required to produce sufficient deflection in the buccal segment of the device can be determined from the geometry and elastic modulus (E) of the material forming the buccal side and the second moment of area (I), which is a function of thickness and width.

[0176] Thus, the thickness of the transverse palatal region (also referred to herein as the "palatal region") can be non-uniform, particularly where the outer surface of the palatal expander has been modified, for example by smoothing. Smoothing can provide more room for the patient's tongue and can improve articulation issues with certain letters. However, the thickness of this region can vary non-linearly to satisfy the tangent conditions at both boundaries and maintain a thickness closer to that of the transverse palatal segment to prevent deformation and articulation of the device before the cusp line. Additionally, the device 457 may include one or more cutout regions 455, including from the front (e.g., see e.g., Figure 4C ) or the rear area, which can enhance comfort, prevent pronunciation problems, etc.

[0177] Figure 13A-13B The gap / offset between the palatal expander segment and the patient's tissue is shown. Figure 13A-13BIn the embodiment of the present invention, the minimum gap at the soft palate (e.g., midline area) can preferably be ~0.5mm (e.g., between 0.01mm and 1mm, between 0.1mm and 0.75mm, etc.) to prevent any contact. Larger gaps may result in food retention. The gap between the palatal surface of the transverse palatal segment and the palate can be controlled palatally. Buccal extension below the gum line; as described above, to provide sufficient mechanical advantage (or torque) for easy removal, the device trim line can extend 1mm-3mm below the gum line. A gap of 0.25mm-1mm between the extension and the gum can be provided to facilitate hooking of the patient's / parent's finger / nail for removal, such as Figure 7B and Fig. 13B shown.

[0178] exist Fig.13A In the example, on the lingual side of the palatal expander, the palatal expander may also include a no-contact area at the gum line. In this example, the gap decreases linearly from 0.5mm at the midline to zero at the gum line. All forces in this example can be applied to the teeth (e.g., tooth-supported palatal expander). Partial contact (tissue-supported palatal expander) can include control points that determine in which area the gap is zero or greater than zero. In this case, forces can be applied to the teeth and palate. The control points can be determined based on a percentage of the palate width. Other variations may include full contact (e.g., no gap) at the lingual side of the crown, which can completely transfer the expansion force / displacement to at least a portion of the tooth and palate side. For example, for the occlusal surface, preferably, full contact (no gap) can include + / -0.1mm; full contact (no gap) + / -0.1mm may be preferred for the buccal side of the crown except for the attachment hole. A gap of 0.25mm-1mm can be provided between the extension and the gums to facilitate hooking the patient's / parent's finger / nail for removal.

[0179] For example, Fig. 13C An example is shown where the palatal expander device includes clearance areas 1305, 1307 above and below the attachment mating site, for example, the attachment hole can include a clearance of about 0.25 mm from the top surface of the attachment. This can provide clearance to compensate for deviations in attachment template manufacturing and attachment formation.

[0180] As described above, the thickness of different areas of the palatal expander can be controlled and can be non-uniform. For example, a transverse palatal segment extending from above the palate to the lingual gum line can have a first thickness or range of thicknesses. An occlusal segment can extend from the lingual gum line across the crown surface to the buccal cusp connection line and can have different thicknesses. A buccal segment can extend from the buccal side of the crown and buccal gum and can be thinner and can also include a hinge area located in front of the occlusal segment.

[0181] Typically, the rigidity of the palatal expander can be balanced with the space of the patient's tongue.For example, any of these devices can include a thin cross-section toward the front and a thick or thicker cross-section toward the back.

[0182] The transverse palatal segment can be defined in the XY plane cross section, as Figure 9A-9B As shown. Fig. 9B In the example shown, for the EFS, a uniform thickness of approximately 4.5 mm is used for the transverse palatal segment. As described above, this thickness may vary or change across the palate. For smoothing purposes, the tolerance for transverse palatal thickness may deviate from the default thickness (see below) on the lingual (tongue) surface of the palatal expander. Figure 14A-Figure 14C Description) For example ~ + 0.5mm. Fig. 9B In some embodiments, the device may include a non-linear transition from the posterior thickness (PTH) to the anterior thickness (ATH) (from the transition line to the anterior facet) utilizing a tangent condition at the transition line, for example, the posterior thickness (PTH) may be between 3mm-4.5mm (may depend on the patient's specific palate shape). The anterior thickness (ATH) may be within the occlusal thickness range (e.g., ~1.5mm). The posterior fillet radius (PFR) may be ~0.5mm and the anterior fillet radius (PFR) may be ~0.5mm. The transition line may be adjusted to ensure the desired transition area. For example, the palatal expander may preferably cover the entire thickness of the molar #6 and #E regions such that the transition occurs in the #D region (see, e.g., Figure 16A-16B ).

[0183] As described above, the lingual surface of any of the palatal expanders described herein may be "smoothed" to reduce valleys (or in some variations, valleys and / or peaks) that would appear on the lingual surface if the thickness were uniform across the palatal region of the palatal expander. Fig.14A An example of a palate region having a sharp curve or transition along the surface is shown, which reflects a similar curve / channel in the patient's palate. Fig. 14B In the case of a palatal expander, this bend / channel has been smoothed in the palatal expander to fill in or reduce the rate of change in the palatal expander surface. Fig. 14C, which is shown in cross section. The original surface 1404 includes many sharply varying grooves or valleys and one main ridge 1406, particularly when compared to a completely smooth surface 1407 projected relative to the actual surface. Although a smooth surface (which fills in the grooves) can be used, in some variations, the ridge 1406 can remain in the final surface 1409. Such a smooth surface can be more comfortable for the patient and can also provide sufficient strength while increasing patient comfort. Smoothing can result in uneven thickness of the transverse palatal segment. Smoothing can also help improve pronunciation, as these grooves / ridges can cause pronunciation problems. The smoothness of the lingual surface of the transverse palatal segment can be increased (e.g., smoothed) to provide comfort in contact with the tongue. In some variations, smoothing can provide a thickness variation of between + / -0.5 mm in this area. The palatal surface of the transverse palatal segment generally does not need to be smooth, as it can be matched to the patient's palate (similarly, the surface in contact with the teeth may also not need to be smooth). The occlusal surface may be smooth (eg, within + / - 0.2 mm); the buccal surface may also be smooth, within + / - 0.2 mm.

[0184] In any of the palatal expander devices described herein, the interproximal region may include a virtual filler. The virtual filler can be used in the interproximal region to design the palatal expander. For example, all three teeth on both sides can be moved in translation in the X direction. For each incremental stage, each side can move half the amount in the expansion. Typically, the anterior teeth are not treated and their movement is not controlled by the palatal expander. The movement ratio can be estimated / predicted based on the suture opening.

[0185] The occlusal cross-sectional thickness may be controlled by tip matching or other surface features (eg, flat surfaces, bevels, etc.). For example, the occlusal surface may include increased thickness for structural integrity, which may be used to open anterior open bites.

[0186] As described above, any of the palatal expanders and retainers described herein may include one or more markings. For example, Fig.12 An example of a logo or part number embedded in a palatal expander is shown, shown on a posterior surface between the occlusal and lingual sides of the palatal expander. For example, a flat surface can be created (e.g., by 3D printing) and a logo or part number 1206 can be printed on it. For example, Fig.12 As shown, the markings can be printed on the rear planar side (e.g., rear surface) and can be sized to fit at least 9 numbers (e.g., oriented upward) that can be read by a patient or can be automatically read. For example, the size of the numbers can be between 8-point font and 16-point font.

[0187] As an alternative or in addition to the engraved indicia described above, the indicia may be or include a machine-readable code, such as a QR code, a barcode, etc. The indicia may be embedded within the device and visible through the device. The indicia may be fluorescent or visible when viewed under certain conditions, such as under UV light, in the dark, etc. Although Fig.12 The markings in the example shown are on the rear edge, but in practice the markings may be placed in any area of ​​the device (or within the device).

[0188] Any of the devices (eg, systems) described herein may include a removal tool such as Fig.15 The removal tool 1504 shown in FIG. For example, the removal tool can be a metal (e.g., stainless steel) device that is shaped to easily enter the disengagement gap of the palatal expander. Fig.15 As shown, one end 1507 can be configured to enter the gap and perform the disengagement hinge. The device can also include a handle area 1509 to allow easy control of the tool. Generally, the disengagement area (or removal handle, etc.) can be configured to be used with a tool (such as Fig.15 ) with the removal tool shown in .

[0189] As mentioned above, Figure 16A-16B The coverage of the teeth by the palatal expander is shown, and possible attachment sites on the teeth for accessories are also shown. Fig.16A In the figure, all D, E and first molars (#6) are shown fully erupted. Teeth: #6, E and D on both sides (alternative numbers: T2, T3, T4 and T13, T14, T15) can be fully or partially covered by the device, and some or all of them can include one or more attachments.

[0190] For example, the overjet of these teeth may include an anterior boundary that deviates between 0 mm and 2 mm from the anterior baseline (eg, Fig. 16B The posterior boundary can be offset from the posterior baseline by 1 mm to 3 mm (as shown) to eliminate the posterior curve of the tooth.

[0191] Figure 17A-17E An exemplary attachment is shown, shown as a semi-cylindrical attachment including a ramp having a pitch angle of approximately 55 degrees. Figure 17A-17E The length of the attachment along the side of the tooth (at Fig.17A Length 1703) is between about 1 mm and 4 mm (e.g., between 1.5 mm and 3 mm, between 2 mm and 3 mm, etc.), and as the attachment extends from the tooth, the width 1753 ( Fig.17D1708 ) tapers gradually, but may have a maximum value of between about 0.5 mm and 4 mm at the tooth surface (e.g., between about 1 mm and 2 mm, etc.). The attachment is tilted downward at an angle (herein referred to as pitch angle 1707) between about 45 degrees and 65 degrees (e.g., between about 50 degrees and 60 degrees, etc.) to reduce the width. The attachment can extend from the tooth, for example, with a protrusion 1759 that is between about 0.5 mm and 3 mm (e.g., between about 0.75 mm and 1.75 mm, between about 1 mm and about 1.5 mm, etc.). As shown in FIG. Fig.17E As shown, the attachment can be spaced about 1 mm and 0.25 mm (e.g., about 0.5 mm and about 0.95 mm) from the patient's gums 1759. The overall global engagement angle can be less than 90 degrees (e.g., less than about 85 degrees, less than about 80 degrees, less than about 75 degrees, etc.). The attachment can be formed as a semi-cylindrical shape with an angled cutout, such as Figure 17A-17E This design provides a beveled surface for ease of insertion as well as a rounded bottom side to reduce stress concentrations. It also aids in removing the template from the mold and attachments in the patient's mouth.

[0192] In particular, the attachments described herein can be shaped and sized to distribute the forces exerted by the palatal expander and teeth on the attachment over a large area of ​​the tooth surface without extending beyond a predetermined buccal area on the tooth (e.g., E and 6 teeth, see e.g. Fig.19A ). As in the above Fig.16A For example, the attachment size and shape can be configured to distribute forces at the center of the crown area of ​​E and / or at the middle tip of the crown of 6.

[0193] Preparing a patient for a palatal expander may optionally include first scanning the patient's upper arch. The digital scan may also be used to monitor / track the progress of the palatal expansion. When scanning a patient's upper arch in order to fabricate a palatal expander device for the patient, it may be helpful to scan a larger area than usual (including the teeth, gums, and palate) in a single scan (or combined scans). For example, Figures 18A-20B Provides examples of scan requirements that can be used. For example, Figure 18A-18B It shows that there is sufficient ( Fig.18A ) and inadequate maxillary arch scan.

[0194] When scanning the upper (maxillary) arch, the scan should include palatal coverage, including coverage of D, E, and 6 (see above Fig.16A ). The scan must provide adequate crown height and extended gingival coverage. For example, for palatal coverage, the palatal scan can capture between about 2mm-3mm beyond the distal surfaces of the D, E, and 6 (e.g., permanent molars) teeth, such as Fig.16ATo place fixed attachments on E and 6, the crown heights of these teeth must be scanned to a square footprint of approximately 3 mm x 3 mm on the sides of these teeth. For example, on E, the attachment would be located in the center of the crown. On 6, the attachment would likely be located at the mid-apex of the crown. This Figure 19A-19B It is shown in the figure that the full ( Fig.19A ) and insufficient ( Fig.19B ) scan (e.g., in a lateral 3×3 or other sized area 1905, 1905'). The scanned gingival coverage should capture the gingiva around D, E, and 6 to within 5 mm below the CEJ line, such as Fig. 20A shown. Fig. 20B Inadequate coverage is shown.

[0195] In use, any device described herein can be inserted by a patient and / or a dental professional. For example, instructions can be provided to the patient for inserting the palatal expander, including first brushing and flossing the teeth. The patient can also confirm that it is the correct device (e.g., by reading a marking on the palatal expander). The palatal expander can then be cleaned (e.g., with a soft-bristled toothbrush, water, and a small amount of toothpaste) and rinsed (e.g., with cold tap water). Then, as Fig.21A As shown, the device 2100 can be inserted into the mouth and as Fig. 21B and Fig. 21C As shown, the palatal expander can be first fully engaged on one side of the expander and then applied to the teeth on the other side. The patient can then bite down to fully secure the device.

[0196] Similarly, the patient may be instructed to remove the device, e.g. Figure 22A-22C To remove the device, the patient may remove the nail 2203 or other device (see, e.g., Fig.15 ) is inserted into the gap at the gingival margin above the attachment ( Fig.22A ) inside, the palatal expander 2200 can then be pulled buccally to disengage the palatal expander from the attachment 2205 on at least one side ( Fig. 22B ), then pull down ( Fig. 22C ). After being removed, the palatal expander can be cleaned with a soft-bristled toothbrush, water, and a small amount of toothpaste. When moving to the next stage (palatal expander), the used palatal expander can be stored or discarded.

[0197] Example 1: Treatment to enlarge a patient's palate

[0198] The apparatus and methods described herein can be used to treat young prepubertal subjects when the child's mouth has grown sufficiently to address the structure of the jaws and teeth while the primary teeth are still in the mouth. Palatal expansion can be used prior to brace treatment; during this treatment, arch development is performed by increasing arch width or depth through dental expansion or palatal expansion to create space for more permanent teeth to erupt. Often, braces may not be able to generate the minimum lateral force required for palatal expansion of the bone that is needed.

[0199] The palatal expander system described herein can assist in the development of the skeleton and dental arches. An example system may include a series of transverse palatal arch features that are intended to produce palatal expansion. The feature is designed to move / expand the palate by extending the maxillary arch outward buccolingually, thereby increasing the lateral palate size by exerting force on the posterior maxillary teeth. For the early feasibility clinical study, no treatment of the lower arch is planned. The expander wearing time is full time. There is a series of expanders that are replaced daily, with an expansion rate of 0.25mm / day. The number of expanders is determined by the amount of expansion required. This also determines the amount of time to perform the expansion. The device is manufactured after obtaining a digital impression scan of the child's teeth and palate.

[0200] The same treatment rate can be provided to the patient, where the length will depend on the amount of expansion, which will be determined by the dentist or dental practitioner. The palatal expander can be replaced once a day, with an expansion rate of 0.25mm per day. The amount of expander provided to the patient can be based on the desired amount of expansion. After the expansion period, there will be a "retention period" where the patient can be in a retention state. The retention period can last for 1-3 months. After the retention period, the patient can use a series of braces to correct the teeth.

[0201] Patients may have stable 6, D, and E and typically require maxillary expansion. Patients may have clinical crown surfaces for accessory placement (3mm H, 3mm V) and may have at least 1 / 2 roots present confirmed by x-ray. Patients may undergo screening prior to starting treatment, including a standard dental history and intraoral scan. The intraoral scan may include a three-dimensional optical digital scan of the subject's dentition and palate, such as using an iTero TM Scanner capture. In addition, radiographs and / or CBCT scans (which capture data using a cone-shaped x-ray beam) can be taken. This data can be used to reconstruct a three-dimensional (3D) image of the patient's dentition and maxillofacial area, providing an undistorted view of the dentition that can be used to accurately visualize erupted and unerupted teeth, root orientation, and abnormal structures.

[0202] Advise patients to wear the device 24 hours a day. It is recommended that each device be worn for 1 day. Ask patients to eat as they normally would while wearing the device. Advise patients to remove the device before bedtime and brush their teeth before placing the next device.

[0203] Potential benefits of this treatment may include expansion of the palate and arches, potentially correcting harmful and adverse malocclusions. Expanding the palate can allow for more room for permanent teeth to erupt because of the space provided. Because the expander is removable, patient hygiene can be improved. Because the expander is manufactured to the patient's anatomy without the use of metal screws or brackets that can irritate the tongue or palate, comfort can be improved. Palatal expansion can improve the patient's ability to breathe and increase the nasal and regional airway.

[0204] The treatment methods described herein may include a series of doctor-prescribed, custom-made, plastic removable orthodontic appliances designed to expand a skeletally narrow maxilla (maxilla, dental arch, and / or palate) during early interceptive treatment of malocclusion. These devices can be used to expand a skeletally narrow maxilla (maxilla, dental arch, and / or palate).

[0205] Any device described herein can be used (e.g., in conjunction) with a fixed bone expander and / or oral surgery to correct severe crowding or jaw imbalance. If oral surgery is required, the risks associated with anesthesia and proper healing must be considered prior to treatment.

[0206] Any features and methods described herein for palatal expanders can be applied to other removable orthodontic appliances, particularly including dental braces. For example, the breakaway regions, articulation regions, slots / slits, removal tools, etc. described herein can be similarly incorporated into a dental brace or a series of dental braces.

[0207] Additionally, although the examples described herein are shown in the context of a palatal expander for use with one or more attachments on a tooth, the devices and methods can be used with devices that do not include attachments. For example, a breakaway region, a smooth lower surface, etc. can be used with a palatal expander that does not include an attachment region for mating with an attachment on a tooth.

[0208] Manufacturing method

[0209] Any of the palatal expanders described herein can be directly manufactured, for example, by digitally designing the expander and using a 3D printer or other direct manufacturing technique to make a digital model. Alternatively or additionally, the palatal expanders described herein can be manufactured indirectly, for example, using a physical model of the patient's dentition (e.g., a ceramic, plastic, plaster, etc. model) to which material is applied to form the palatal expander. Indirect manufacturing methods may include lamination, where the palatal expander is formed from laminated layers or laminated portions. Indirect manufacturing methods may also include directly manufacturing a model using direct manufacturing techniques (e.g., 3D printing, etc.). Hybrid manufacturing methods may also be used, where a portion of the expander is directly manufactured and then combined with other elements (including layers or supports) with or without a model of the patient's dentition.

[0210] Before or at the beginning of any manufacturing method described herein, a user (technician, engineer, dentist, dental assistant, etc.) can plan a series of palatal expansions. When planning the series, the user can indicate the goals of the series of palatal expanders. The goals may include the final and any intermediate palatal expander positions, the maximum and / or minimum forces applied, the location of the forces applied in the oral cavity, the separation between the palate and the palatal expander, the maximum and / or minimum expansion of each expander (e.g., the separation between the molars on opposite sides of the patient's mouth), the number of palatal expanders in the series, the maximum and / or minimum wearing time of each palatal expander, etc. In some variations, the user can indicate the material and / or thickness and / or curvature of the palatal expander. Any of these goals can be automatically selected or chosen, or default values ​​can be provided and adjusted by the user. Any of these goals can be constraints or can be allowed to vary, including within a predetermined and / or user-selected range.

[0211] After the series of palatal expanders have been planned, they can be manufactured; the manufacturing can be done all at once or in batches (e.g., provided as a whole or partial group (e.g., 1-4 days)) or individually and provided to the patient. Each expander can be marked to identify it individually, including markings to indicate a preferred order (e.g., first, second, etc.).

[0212] In any of the indirect manufacturing techniques described herein, the expander can be formed on a physical model that has been adjusted (e.g., by moving the palate) to the desired position on the way to the final expanded position. As described above, the physical model can include attachments (buttons, etc.) for coupling to attachments (e.g., through holes, etc.) on the expander.

[0213] When a physical model is used (generated manually from an impression of the patient's teeth or from one or more digital models), the expander can be made by molding a piece of material onto the model. Generally, any suitable material can be used for the expander, as long as it is sufficiently biocompatible and has the required rigidity and physical properties (alone or in combination with other materials). For example, the expander can be formed from an acrylic material that is applied to the physical model in sheet form, shaped (e.g., thermoformed, set) and then cut and / or trimmed. In various examples provided herein, the material can be formed (including set) by temperature and / or light or other appropriate means. For example, the expander can be formed from a thermoplastic curable polymer.

[0214] The expander can be formed using a stamping process. For example, Fig.33AAn example of a stamping process is shown where a top "male" mold 1101 is used to press a sheet of material (a "triad sheet" 1100, comprising a thermoplastic material) into a bottom "female" mold 1103 of the expander. The top and bottom molds can be formed from 3D printed materials (e.g., an acrylic material such as SLA), which can be generated from a digital model of the expander. The method includes a thermoforming step in that the film is first stamped and then thermoformed after or during the stamping process, as shown. The "triad sheet" 1100 in this embodiment is an acrylic sheet of appropriate thickness. As Fig.33B As shown, the mold itself can include a cutting edge 1105 to help trim the borders of the stamped sheet, or it can be trimmed separately. In addition, the sheet can be cured after stamping (or during stamping in some variations). Post-processing can include polishing / cleaning of the trimming tool to smooth the edges. In this example, the thickness of the material can be defined by the mold, and each mold is customized for the patient. Fig.33A and Fig.33B The method shown in provides a sandwich technique in which a curable, flexible acrylic sheet is pressed between a male mold and a female mold. Thus, the expander is thermoformed on the male mold after the thermoforming process; the acrylic sheet can be placed on top. Excess of the pressed acrylic sheet can be trimmed off by cutting edge 1105, which also serves as a spacer between the two molds. The acrylic sheet can be cured by light passing through the transparent mold from either the male mold side or the female mold side.

[0215] Fig.34A is an example of a spring rolling technique used to form an expander. In this example, a mold of the patient's jaw can be made. Next, the expander can be thermoformed on top of the mold, and an acrylic monomer resin or other adhesive can be sprayed on top of the plastic sheet. Thereafter, a triplet sheet can be applied on top of the plastic film, and a roller can be used to press the triplet sheet on top of the plastic sheet. Fig.34B As shown, this roller technology can use a similar principle to a mechanical lock, where multiple pins are inserted into holes and springs can push the pins out. As the roller moves over the triplet sheet, the pins can be pushed in and can thus conform to the shape of the crown; sufficient force can press the triplet sheet tightly against the crown surface. The spring strength can control the force to achieve the best effect. Thereafter, UV light can be used to cure the triplet sheet.

[0216] Fig.35An example of a casting technique is shown. In this example, the material is first formed to form a mold (e.g., by 3D printing). The material can then be thermoformed, and an acrylic resin to form the expander can be placed in the cavity (by filling it with resin) for casting. Once cured, the two molds (top and bottom) can be removed and the appliance cut from the mold.

[0217] There are two molds (piece #1 and piece #2) in this example. When the expander is formed from two materials (e.g., a first material and a pourable resin), the first material can be thermoformed into a male mold (e.g., as described above), and the male mold can be secured to a female mold. The mold can be designed so that there is a cavity with a thickness optimized for device hardness. The pourable resin can then be poured into the cavity and cured. The molds can then be separated again.

[0218] Fig.36 Another variation of the fabrication technique is shown, where a mask can be used to limit or prevent curing when forming the device. In this example, areas that should remain uncured (e.g., for removal) can be masked; this can allow for precise cut lines of the acrylic sheet of the device. This technique can be applied to any of the methods described herein. A thermal mask for a thermal curing process can be used; for light / UV curing techniques, an optical mask can be used.

[0219] Fig.37 An example of a method of making an expander is shown in which a roller (e.g., a "CNC roller") is used. In this example, the expander material can be thermoformed to a mold. For example, an uncured, pliable acrylic sheet can be placed on the expander material (e.g., mold). A roller controlled by a CNC (computer numerical control) can then be used to flatten the acrylic sheet to a desired thickness, which can be non-uniform (e.g., variable).

[0220] Fig.38 is another example of a manufacturing technique where multiple layers can be deposited, using masks to control the final shape / size. For example, as a first step, the expander material can be thermoformed onto a mold, such as an SLA mold, as shown on the far left. Thereafter, an adhesive solution can be printed (e.g., by inkjet printing) on ​​one or more specific areas. Thereafter, a UV blocker solution can be printed on specific areas, for example, using a second injection printhead (or the same printhead using a second solution). Thereafter, an acrylic resin (e.g., a triplex gel) can be placed on top of it, or a triplex sheet can be pressure formed on top. Thereafter, UV light can be used to cure the triplex material and actuate the UV adhesive material (see Fig.38 , center). The shape can then be cleaned and cut, for example, by applying a high pressure water jet to flush away uncured material (gel), cleaning the entire device ( Fig.38Right). Finally, the device can be laser cut to trim the dilator on the trim line.

[0221] Fig.39 An alternative to using UV blockers is shown, where a dynamic UV mask (such as an LCD mask) can be used. As an alternative to UV blockers, a UV DLP or LCD projector can be used instead of a normal UV lamp. This can allow for more precise positioning. Similarly, optical masks (such as those used during lithography) can be used, as well as any other lithography process.

[0222] exist Fig.40 , an injection molding method that can be used is described. In this example, the mold can first be formed to include top (e.g., male) and bottom (e.g., female) molds, including crowns, with a gap therebetween. The gap can form the shape of an expander device. A thin plastic sheet can be placed over the top mold half and the bottom mold half for thermoforming, and the mold pieces can be clamped together. Thereafter, a fluid can be injected / filled into the mold; the fluid can be a liquid resin that is injected into the gap / cavity between the two molds. Excess resin can be caused to flow out of the gap through a hole / outlet. Light can then be used to cure the resin. As described above, the final device can be removed, trimmed, cleaned, and polished.

[0223] Fig.41 Another method for printing all or part of a dilator is shown. Fig.41 In the , the expander is formed by printing a thermoset material onto a base. Fig.41 In the process, a core material (e.g. acrylic) is deposited by heating and dispensing onto a thermoformed base layer. Variable thicknesses can be applied as required and controlled by digital design of the spreader. Automated equipment can be used to dispense and apply the material. After cooling, the core material can be laminated to the base layer. Additional layers can be applied selectively.

[0224] like Fig.42 As shown, all or part of the expander can be formed by blow molding. In this example, blow molding can be used to make a hollow transverse palatine arch (TPA), similar to the way PET beverage bottles are made. The hollow TPA can be filled with solid material in a subsequent step. The molded blocks can be formed and used in standard sizes such as small, medium and large; customization can be made in downstream steps.

[0225] As already described, deposition may be used to form any of the dilators described herein. Fig.43An example of a general method using deposition is shown. Based on the material properties and original form of the expander, any combination of dispensing or deposition methods and systems can be used for specific steps of the manufacturing process described herein. For example, for low viscosity solutions, a dispensing mechanism can be used, while for high viscosity solutions, an extrusion and deposition mechanism is used. For example, a pneumatic pressurized nozzle, a spiral valve, a solenoid valve, an ultrasonic print head, a thermal print head, a piezoelectric print head, etc. can be used.

[0226] Fig.44 Another method of forming a dilator is shown in which a nozzle is used to apply a heated acrylic material (e.g., Triplex Gel) and one or more mechanical shapers / cutters ("blades") may be used to cut the material. In this method, a hardened material may be applied to a well-defined thickness over a curved dilator surface. The thickness of the material may be adjusted by adjusting the legs of the applicator as the material is laid down. The apparatus that forms the thickness may be heated for use with thermally responsive materials.

[0227] Fig.45 Another example of a pressure forming method for forming an expander is shown. In this example, air pressure can be used to mold / conform the material (e.g., a triplet sheet) into the expander. Initially, a sheet of material can be thermoformed onto a mold (forming a "thermoformed expander" on the mold, such as Fig.45 ). Adhesive can then be added to the mold using air pressure, but no heat, to "press" the triplex sheet onto the expander. This can be used to select and modify the thickness of the device. Next, the excess expander can be cut off using a CNC, and the material can be cured.

[0228] For example, the pressure forming technique can be performed using a flexible acrylic sheet placed on a thermoplastic material. A male mold is used to form the thermoplastic, and pressure is applied at different pressures from different locations. An intermediate material (e.g., a rubber sheet) can be used (e.g., by placing the rubber sheet between the mold and the sheet (or between the air pressure source and the triplet sheet) to help capture the sheet onto the mold.

[0229] Direct Manufacturing

[0230] As described above, direct manufacturing can be used to make any expander described directly using a digitally designed expander (e.g., a digital file specifying the geometry) as input. Thus, these devices can be formed without the need for a physical model of the patient's teeth / gums / palate. Direct manufacturing can include 3D printing or additive manufacturing (e.g., extrusion, photopolymerization, powder bed, lamination, powder feed, etc.).

[0231] For example, Fig.46An example of a direct manufacturing process involving injection molding is shown. In this example, the mold can be 3D printed (the entire casting mold) and injection molded. For example, the entire casting block can be made by 3D printing, and the block can have the negative shape of the final design. The block can have an injection port that allows a heat-curable material or a light-curable material to be injected to fill the cavity. After the injected material solidifies, the mold can be broken and opened.

[0232] Another example is Fig.47 As shown, a standard approach to a two-layer system including direct thermoforming is shown. The design requires only a small number of standard TPA geometries to be manufactured, with the goal of forming standardized parts with minimal customization requirements. The standard TPA (base) can be milled to a custom shape for the patient's bite line. The TPA reinforcement can then be attached to the expander by a thermoformed interlayer (e.g., the top and bottom layers are the expander material), and the top and bottom are attached by adhesive and / or mechanical interlocking.

[0233] Fig.48A An example of a mechanical interlock or latch is shown. In this example, a device is formed by including a mechanical interlock between two components (e.g., an upper layer and a lower layer). For example, the device may include some male and / or female features on top of a reinforcement and a thermoformed expander. The two layers (including a stiffer layer and a more flexible layer) may then be interlocked together. Similarly, in Fig.48B In the embodiment of the present invention, the two layers can be mechanically locked together. The features of the layers can grab or interlock, for example, the more flexible layer can interlock with the reinforcement component after press fitting.

[0234] Fig.49A and Fig.49B A method of insert injection molding to form an expander is shown. In this example, the device can be formed by applying thermoplastic material to a mold (e.g., a 3D printed mold customized for the patient's mouth), then removing the piece and placing it into a custom designed 3D printed mold so that there is space at the bottom and top (e.g., between the 3D formed surface and a more generic surface), and then injecting resin into the space to form the expander. Typically, the device requires some flexibility to snap into the crown and engage the retaining attachment, while requiring rigidity from the transverse palatal arch to generate lateral forces and stiffness; a combination of flexible and rigid areas can be achieved through this approach, for example, by inserting a thermoformed expander with TPA into a mold where rigid material can be injected on top of or around the TPA portion of the expander.

[0235] laminated

[0236] Any of the dilators described herein can be formed by one or more lamination processes, where multiple layers are attached together sequentially or simultaneously to form the dilator.Lamination methods can generally include using thermoplastic layers of various thicknesses and combining them to form the various layers.

[0237] For example, Fig.50 A method of forming an expander having a single layer (a "single piece" expander) is shown. In this example, the entire device can be thermoformed on a mold using one thick sheet of thermoplastic. The gum line and TPA portions can then be cut out of the molded device using an automated laser or milling process.

[0238] Fig.51 A two-piece (two-layer) device is shown. In this example, greater flexibility can be achieved when the device is manufactured by lamination (e.g., on crowns, to engage retaining attachments, etc.). For example, the device can be thermoformed to a TPA (transverse palatal arch) using a thick thermoplastic sheet. Fig.50 As shown, the TPA can be cut using an automated laser or milling process. Once formed, the TPA can be placed into a mold and another layer can be thermoformed / laminated on top of the TPA; this layer can be a flexible layer that can extend over the crown and engage with the retaining attachment (e.g., the attachment area discussed above).

[0239] As many additional layers as are necessary and useful may be applied. See e.g. Fig.52 The layers may be laminated by adhesive or by thermoforming. Note that laser welding may be used to seal the (intermediate) reinforcement layer to encapsulate it, which may be made of biocompatible materials by various manufacturing methods.

[0240] In general, lamination may use thermoplastic layers of various thicknesses which may be combined.

[0241] For example, Fig.53 Another example of a method of laminating two (or more) layers by laser welding is shown. In this example, a thick TPA region can be made of a biocompatible material by various manufacturing methods, as described herein, and laser welded to a thermoformed base expander. Alternatively or additionally, other bonding methods can be used, including chemical adhesives. Fig.54 In the embodiment of the present invention, a separate tooth abutment area ("tooth crown area") can be attached or laminated separately. For example, the TPA area can be laser welded to a flexible portion that covers the tooth crown and is joined to the retaining attachment (tooth abutment area).

[0242] Fig.55A method of thermoforming specific "standard" TPA areas to a custom part to form an expander is shown. The design may involve manufacturing only a small number of standard TPA geometries (e.g., small, medium, and large) and using thermoforming materials to customize the other parts. The use of thermoforming layers enables the standard TPA shape to be contoured in situ to the patient's palate shape by applying heat and pressure. At the same time, a thin expander layer can be thermoformed onto the occlusal surface and laminated to a thicker TPA.

[0243] Similarly, Fig.56 Various standard / generic shapes that may be used as part of an expander are schematically shown. For example, in any of these methods, as appropriate, the method may include the design of an injection molded "blank" (i.e., two large blocks connected by a "generic" TPA) where the blocks (tooth engagement areas) may be customized by (1) milling the patient's crown shape from the blocks or (2) milling the entire device from a single block.

[0244] In any of these variations, the injection molded "blank" (i.e., two blocks connected by a "universal" TPA) can be customized by milling the connection geometry and connected to the expander using an adhesive and / or by welding (e.g., laser welding) as described above. Alternatively or additionally, the injection molded "blank" (i.e., two blocks connected by a "universal" TPA) can be customized by milling mechanical features that will be used to connect to the expander. In any of these examples, the injection molded "blank" (i.e., two blocks connected by a "universal" TPA) can be customized by milling the connection geometry and the expander shape laminated thereon for customization.

[0245] Any process for custom injection molds can be used to make these devices. Generally, these devices can contain two or more materials as part of a rapid palatal expander using any direct manufacturing method or other technique. The transverse palatal arch (TPA) region, also known as the palatal region, can be made of a hardened material. Through covalent bonding or adhesives, the device can seamlessly transition from the more rigid palatal region to a more flexible material for the tooth retaining region to enable the device to remain on the crown. The entire device may appear smooth.

[0246] Other variations of the expanders described herein may include devices having additional force-applying elements, including magnetic elements, such as Fig.57 As shown. In this example, magnets are placed on the upper, posterior, left and right sides of the tongue arch. The magnets have similar charges so that they repel each other. This magnetic force provides the force to expand the palate. The magnets can then be inserted or adhered to the aligner, connected to a metal band, or can be adhered directly to the teeth or palate.

[0247] exist Fig.58In the example, the expander includes an occlusal surface and certain portions of a palatal expander that can be attached to the patient's crown. A separate piece that applies the expansion force can be snapped in and placed between the left and right adhesive components and fixed at a certain distance between the two halves. The snap-in component can provide a force to expand the palate and can be gradually increased for each of the subsequent treatment stages. In this example, the occlusal surface and certain portions of the palatal expander can be formed by any of the above-mentioned manufacturing techniques (including 3D printing, CNC milling, injection molding, etc.). The snap-in component can also be 3D printed, milled or molded.

[0248] In general, the stiffness of the bow can be adjusted by using one or more different materials and / or by increasing or decreasing the thickness as described herein. Fig.59 As shown, the firmness can also be adjusted by folding or wrinkling the palate area.

[0249] When a feature or element is referred to as being "on" another feature or element in this article, it can be directly located on the other feature or element, and / or there can also be intermediate features and / or elements. On the contrary, when a feature or element is referred to as being "directly" located on another feature or element, there are no intermediate features or elements. It should also be understood that when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to another feature or element or there can be intermediate features or elements. On the contrary, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown with respect to one embodiment, the features and elements described or shown in this way can be applied to other embodiments. It will also be understood by those skilled in the art that the structure or feature mentioned to be "adjacent" to another feature may have a part overlapping with an adjacent feature or being located under an adjacent feature.

[0250] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, unless the context clearly indicates otherwise, as used herein, the singular forms "one", "an" and "the" are intended to also include plural forms. It should be further understood that when used in this specification, the terms "include" and / or "comprise" specify the presence of the features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more related listed items and can be abbreviated as " / ".

[0251] Spatial relative terms, such as "below", "below", "lower", "above", "on", etc., may be used herein for ease of description, to describe the relationship between an element or feature as shown in the figure and another one or more elements or features. It should be understood that spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation shown in the figure. For example, if the device in the figure is reversed, the element described as "below" or "below" other elements or features will be "oriented" to be located "above" other elements or features. Therefore, the exemplary term "below" can include the direction of above and below. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative narration used herein is interpreted accordingly. Similarly, unless otherwise expressly stated, the terms "upward", "downward", "vertical", "horizontal", etc. used herein are only for the purpose of explanation.

[0252] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms can be used to distinguish one feature / element from another feature / element. Thus, the first feature / element discussed below can be referred to as the second feature / element, and similarly, the second feature / element discussed below can be referred to as the first feature / element without departing from the teachings of the present invention.

[0253] Throughout the specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "including" and "comprising" mean that various components can be used together in methods and articles (e.g., including components of apparatus and methods and devices). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0254] In general, any apparatus and method described herein should be understood to be inclusive, but all or a subset of components and / or steps may alternatively be exclusive and may be expressed as "consisting of" or alternatively "consisting essentially of" the various components, steps, sub-components or sub-steps.

[0255] As used in this specification and claims, including as used in the examples, unless otherwise expressly stated, all numbers can be read as if preceded by "about" or "approximately", even if the word does not appear explicitly. The phrase "about" or "approximately" can be used when describing magnitude and / or position to indicate that the value and / or position described are within the range of reasonable expected values ​​and / or positions. For example, a numerical value may have a value of + / -0.1% of the value (or range of values), + / -1% of the value (or range of values), + / -2% of the value (or range of values), + / -5% of the value (or range of values), + / -10% of the value (or range of values), etc. Unless the context indicates otherwise, any numerical value given herein should also be understood to include about or approximately the value. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range cited herein is intended to include all subranges contained therein. It should also be understood that when a value is disclosed as "less than or equal to" the value, then "greater than or equal to the value" and possible ranges between values ​​are also disclosed, as will be appropriately understood by those skilled in the art. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points, as well as ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, equal to 10 and 15, and between 10 and 15 are considered disclosed. It should also be understood that each single digit between two specific single digits is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0256] Although various illustrative embodiments are described above, any of a number of changes may be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which the various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various device and system embodiments may be included in some embodiments and not in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be viewed as limiting the scope of the invention as described in the claims.

[0257] The examples and illustrations included herein show specific embodiments of the subject matter that can be practiced by way of illustration and not limitation. As described above, other embodiments can be utilized and derived therefrom, so that structural and logical replacements and changes can be made without departing from the scope of the present disclosure. These embodiments of the subject matter of the present invention may be referred to herein individually or collectively by the term "invention", only for convenience and not intended to voluntarily limit the scope of the present application to any single invention or inventive concept, if more than one is in fact disclosed. Therefore, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all changes or variations of various embodiments. After reading the above description, the combination of the above-mentioned embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. A palate expander device for expanding the palate of a patient, the device comprising: a pair of tooth engagement regions connected by a palatal region, wherein the palatal region is configured to apply a force between 8 N and 160 N between the pair of tooth engagement regions when the device is worn by the patient; as well as A visible identification mark is recessed into or extends from the posterior surface of the palatal expander device, wherein the identification mark encodes one or more of the following: a patient number, a revision indicator, an indicator that the device is a palatal expander or retainer, and a treatment stage.

2. The device according to claim 1, wherein The palate region has a thickness of between approximately 1 mm and 5 mm.

3. The device according to claim 1, wherein: The occlusal side of the palatal expander has a thickness between approximately 0.5 mm and 2 mm.

4. The device according to claim 1, wherein: The buccal side of the palatal expander has a thickness between approximately 0.25 mm and 1 mm.

5. The device according to claim 1, wherein: The anterior portion of the palate region has a different average thickness than the posterior portion of the palate region.

6. The device according to claim 1, wherein: The front portion of the palate region is thinner than the back portion of the palate region.

7. The device according to claim 1, wherein: The palate region comprises an upper convex surface having a first surface curvature; and wherein the palate region comprises a lower concave surface having a second surface curvature, the second surface curvature being smoother than the first surface curvature.

8. The device according to claim 1, wherein: the palate region comprising an upper convex surface having a first surface curvature, the upper convex surface comprising a plurality of grooves and ridges that align with grooves and ridges in the patient's palate; And wherein the palate region comprises a concave surface having a second surface curvature, the second surface curvature being smoother than the first surface curvature.

9. A palate expander device for expanding the palate of a patient, the device comprising: a pair of tooth engagement regions connected by a palatal region, wherein the palatal region is configured to apply a force between 8 N and 160 N between the pair of tooth engagement regions when the device is worn by the patient; wherein each of the tooth engagement regions comprises an occlusal side and a buccal side, wherein for at least one of the tooth engagement regions: The occlusal side is thinner than the palatal area, the buccal side is thinner than the occlusal side, and the thickness of the transition area between the occlusal side and the buccal side decreases from the occlusal side to the buccal side; The hinge region on the buccal side is configured to flex to release the device from the patient's teeth when a force is applied to pull the buccal side away from the patient's teeth or gums.

10. A palate expander device for expanding the palate of a patient, the device comprising: A pair of tooth engagement regions connected by a palatal region, wherein the palatal region is configured to apply a force between 8N and 160N between the pair of tooth engagement regions when the device is worn by the patient, wherein the palatal region is configured to have a gap of 0.1mm to 10mm with a mid-palatal region of the patient when the patient wears the device, and wherein each of the tooth engagement regions includes an occlusal side and a buccal side, wherein for at least one of the tooth engagement regions: an extension extending from the buccal side, wherein the extension is configured to extend adjacent to and away from the patient's gums to form a gap of between about 0.25 mm and 1 mm when the patient wears the device; The occlusal side is thinner than the palatal area, the buccal side is thinner than the occlusal side, and the thickness of the transition area between the occlusal side and the buccal side decreases from the occlusal side to the buccal side; The hinge region on the buccal side is configured to flex to release the device from the patient's teeth when a force is applied to pull the buccal side away from the patient's teeth or gums.

11. A palate expander device for expanding the palate of a patient, the device comprising: A pair of tooth engagement regions connected by a palatal region and two or more attachment regions, each of the attachment regions being configured to couple with an attachment bonded to the patient's teeth, wherein each of the tooth engagement regions comprises an occlusal side and a buccal side, wherein for at least one of the tooth engagement regions: The occlusal side is thinner than the palatal area, the buccal side is thinner than the occlusal side, and the thickness of the transition area between the occlusal side and the buccal side decreases from the occlusal side to the buccal side; The hinge region on the buccal side is configured to flex to disengage at least one of the attachment regions from a corresponding attachment on the patient's tooth when a force is applied to pull the buccal side away from the patient's tooth or gum.

12. A palate expander device for expanding the palate of a patient, the device comprising: A pair of tooth engagement regions connected by a palatal region and at least one attachment region configured to couple with an attachment bonded to the patient's teeth, wherein each of the tooth engagement regions includes an occlusal side and a buccal side, wherein for at least one of the tooth engagement regions: The occlusal side is thinner than the palatal area, the buccal side is thinner than the occlusal side, and the thickness of the transition area between the occlusal side and the buccal side decreases from the occlusal side to the buccal side; and The hinge region on the buccal side is configured to flex to disengage at least one of the attachment regions from a corresponding attachment on the patient's tooth when a force is applied to pull the buccal side away from the patient's tooth or gum.

13. A palate expander device for expanding the palate of a patient, the device comprising: a pair of tooth engagement regions connected by a palatal region, wherein the palatal region is configured to apply a force between 8N and 160N between the pair of tooth engagement regions when the device is worn by the patient, and a breakaway area on at least one of the tooth engagement areas, the breakaway area being defined by one or more first vertical cutout areas extending from a bottom of the buccal side of at least one of the tooth engagement areas toward a corresponding occlusal side of at least one of the tooth engagement areas and terminating at a point on the buccal side between the bottom of the buccal side and the corresponding occlusal side, wherein the buccal side is more flexible than the corresponding occlusal side such that the breakaway area bends when a removal force is applied to the breakaway area to release the palatal expander device from the patient's palate.

14. A palate expander device for expanding the palate of a patient, the device comprising: a pair of tooth engagement regions configured to be placed on the patient's molars, the pair of tooth engagement regions being connected by a palatal region configured to apply a force between the pair of tooth engagement regions when the patient wears the device, wherein at least one of the pair of tooth engagement areas includes a breakaway area defined by one or more vertical cutout areas extending from a bottom of the buccal side of the at least one tooth engagement area toward an occlusal side of at least one of the at least one tooth engagement areas and terminating at a point on the buccal side between the bottom of the buccal side and the occlusal side, wherein the buccal side is more flexible than the occlusal side such that the breakaway area bends when a removal force is applied to the breakaway area to release the palatal expander device from the patient's palate.

15. A method of manufacturing a palatal expander device, the method comprising: Receive a model of the patient's upper arch; forming a palatal expander having a pair of tooth engagement regions connected by a palatal region, wherein each of the tooth engagement regions is configured to fit over a tooth of the patient and each of the tooth engagement regions includes an occlusal side and a buccal side; and A breakaway area is formed by forming one or more vertical cut areas from the bottom of the buccal side of one tooth engagement area toward the corresponding occlusal side of the one tooth engagement area and terminating at a point on the buccal side between the bottom of the buccal side and the corresponding occlusal side, wherein the buccal side is more flexible than the corresponding occlusal side so that when a removal force is applied to the breakaway area to release the palatal expander device from the patient's palate, the breakaway area bends.

16. A palate expander device for expanding the palate of a patient, the device comprising: a pair of tooth engagement regions connected by a palatal region, wherein the palatal region is configured to apply a force between the pair of tooth engagement regions when the patient wears the device; and wherein each of the tooth engagement regions comprises an occlusal side and a buccal side, and wherein at least a portion of the palatal region is constructed to have a gap greater than 0.1 mm with a mid-palatal region of the patient when the patient wears the device, wherein the gap between the palatal region and the patient's palate decreases laterally from the mid-palatal region of the patient toward the pair of tooth engagement regions.

17. A palate expander device for expanding the palate of a patient, the device comprising: a pair of tooth engagement regions connected by a palatal region, wherein the palatal region is configured to apply a force between the pair of tooth engagement regions against a lateral region of the patient's palate when the patient wears the device; and wherein each of the tooth engagement regions comprises an occlusal side and a buccal side, wherein the occlusal side is thinner than the palatal region, and wherein at least a portion of the palatal region is constructed to have a gap greater than 0.1 mm with a mid-palatal region of the patient when the patient wears the device, wherein the gap between at least a portion of the palatal region and the patient's palate decreases laterally from the mid-palatal region of the patient toward the pair of tooth engagement regions.

18. A series of palatal expander devices having an ordered sequence for expanding the palate of a patient, the series of palatal expanders comprising: First palatal expander, including: a first pair of tooth engagement regions connected by a first palatal region, wherein the first palatal region is configured to apply a force between the first pair of tooth engagement regions when the first palatal expander is worn by the patient; and wherein each of the first tooth engagement regions includes an occlusal side and a buccal side, and wherein at least a portion of the first palatal region is configured to have a gap greater than 0.1 mm with a mid-palatal region of the patient when the patient wears the device, wherein the gap between the first palatal region and the patient's palate decreases laterally from the mid-palatal region of the patient toward the first pair of tooth engagement regions; and A second palatal expander configured to be worn later in an ordered sequence than the first palatal expander, the second palatal expander comprising: a second pair of tooth engagement regions connected by a second palatal region, wherein the second palatal region is wider than the first palatal region and is configured to apply a force between the second pair of tooth engagement regions when the second palatal expander is worn by the patient; and Wherein, at least a portion of the second palatal region is constructed to have a gap greater than 0.1 mm with the patient's mid-palatal region when the patient wears the device, wherein the gap between the second palatal region and the patient's palate decreases laterally from the patient's mid-palatal region toward the second pair of tooth engagement area.

19. A series of sequential palatal expanders configured to be worn sequentially by a patient during palatal expansion therapy, a first palatal expander in the series comprising: a left dental engagement region having one or more tooth receiving cavities shaped to receive one or more posterior teeth of the left side of the patient's maxilla; a right dental engagement region having one or more tooth receiving cavities shaped to receive one or more posterior teeth of the right side of the patient's maxilla; as well as a palatal region extending between the left tooth articulation region and the right tooth articulation region and configured to traverse the patient's palate when the patient wears the first palatal expander, wherein: The palate region includes an anterior region and a posterior region, wherein, along a sagittal line between the anterior region and the posterior region, at least a portion of the anterior region is thinner than the posterior region, and At least a portion of the palatal region is configured to have a gap greater than 0.1 mm with a mid-palatal region of the patient when the patient wears the first palatal expander.

20. A method of forming a series of palatal expanders having a sequence, the series of palatal expanders being configured to be worn sequentially by a patient in a palatal expansion treatment, the method comprising forming a first palatal expander in the series of palatal expanders by: forming a left tooth articulation region having one or more tooth receiving cavities shaped to receive one or more posterior teeth of a left side of a maxillary bone of the patient; forming a right dental articulation region having one or more tooth receiving cavities shaped to receive one or more posterior teeth of a right side of the patient's maxilla; as well as forming a palatal region extending between the left and right tooth articulation regions and configured to traverse the patient's palate when the patient wears the first palatal expander, wherein: The palate region includes an anterior region and a posterior region, wherein, along a sagittal line between the anterior region and the posterior region, at least a portion of the anterior region is thinner than the posterior region, and When the patient wears the first palatal expander, at least a portion of the palatal region is configured to have a gap greater than 0.1 mm with the mid-palatal region of the patient.

21. A series of sequential palatal expanders configured to be worn sequentially by a patient during palatal expansion therapy, a first palatal expander in the series comprising: a left dental articulation region having one or more tooth receiving cavities shaped to receive one or more posterior teeth of the left side of the patient's maxilla; a right dental engagement region having one or more tooth receiving cavities shaped to receive one or more posterior teeth of the right side of the patient's maxilla; as well as a palatal region extending between the left tooth articulation region and the right tooth articulation region and configured to traverse the patient's palate when the patient wears the first palatal expander, wherein: The palate region includes an anterior region and a posterior region, wherein, along a sagittal line between the anterior region and the posterior region, at least a portion of the posterior region is thinner than the anterior region, and At least a portion of the palatal region is configured to have a gap greater than 0.1 mm with a mid-palatal region of the patient when the patient wears the first palatal expander.

22. A method of forming a series of palatal expanders having a sequence, the series of palatal expanders being configured to be worn sequentially by a patient during palatal expansion therapy, the method comprising forming a first palatal expander in the series of palatal expanders by: forming a left tooth articulation region having one or more tooth receiving cavities shaped to receive one or more posterior teeth of a left side of a maxillary bone of the patient; forming a right dental articulation region having one or more tooth receiving cavities shaped to receive one or more posterior teeth of a right side of the patient's maxilla; as well as forming a palatal region extending between the left and right tooth articulation regions and configured to traverse the patient's palate when the patient wears the first palatal expander, wherein: The palate region includes an anterior region and a posterior region, wherein, along a sagittal line between the anterior region and the posterior region, at least a portion of the anterior region is thinner than the posterior region, and At least a portion of the palatal region is configured to have a gap greater than 0.1 mm with a mid-palatal region of the patient when the patient wears the first palatal expander.

23. A series of palatal expanders having a sequence, which are configured to be worn sequentially by a patient during palatal expansion treatment, a first palatal expander in the series of palatal expanders comprising: a left dental articulation region having one or more tooth receiving cavities shaped to receive one or more posterior teeth of the left side of the patient's maxilla; a right dental engagement region having one or more tooth receiving cavities shaped to receive one or more posterior teeth of the right side of the patient's maxilla; as well as a palatal region extending between the left tooth articulation region and the right tooth articulation region and configured to traverse the patient's palate when the patient wears the first palatal expander, wherein: The palate region includes an anterior region and a posterior region, wherein, along a sagittal line between the anterior region and the posterior region, at least a portion of the posterior region is thinner than the anterior region, and At least a portion of the palatal region is configured to have a gap greater than 0.1 mm with a mid-palatal region of the patient when the patient wears the first palatal expander.

Images