Device for aligning teeth with invisible braces for sleep apnea

Abstract

An oral alignment appliance uses an upper alignment tray and a lower alignment tray to align a user's dentition while treating sleep apnea. The upper alignment tray and the lower alignment tray can be connected to each other by a strut that is removably connected to each of the upper alignment tray and the lower alignment tray and configured to move the user's lower jaw forward while the upper alignment tray and the lower alignment tray align the user's dentition to treat sleep apnea. One or more of the upper alignment tray and the lower alignment tray and the strut can be periodically replaced as part of a concurrent progressive alignment treatment or an adjustment to the treatment of sleep apnea.

Description

[0001] Cross-references to related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 627,771, filed January 31, 2024, the entire contents of each of which are incorporated herein by reference. Technical Field

[0002] An oral sleep appliance comprising an orthodontic aligner and an associated method for providing treatment for obstructive sleep apnea and for correcting misaligned dentition in users. Background Technology

[0003] Sleep apnea is a common medical condition during which a person experiences one or more pauses in breathing and / or shallow breathing during sleep. While several types of sleep apnea exist, the most common type is obstructive sleep apnea. In this condition, one or more muscles in the throat relax during sleep, causing the surrounding tissues in the back of the mouth, nose, and throat to collapse and obstruct the airway. People with obstructive sleep apnea have insufficient oxygen exchange during sleep, which can lead to daytime fatigue, poor concentration, and mood changes. If left untreated, obstructive sleep apnea can have significant health consequences, often resulting in cardiovascular disease, stroke, and metabolic disorders.

[0004] Known methods for treating obstructive sleep apnea include surgical procedures or interventions as well as non-surgical devices. A popular surgical procedure is uvulopalatopharyngoplasty, in which a portion of the soft palate is removed in an attempt to prevent excessive tissue from closing the airway during sleep. However, this surgery has the disadvantages of being often expensive and potentially damaging the laryngeal muscles necessary for swallowing and / or causing other undesirable conditions such as nasal regurgitation. To mitigate this risk, various non-surgical methods have been employed. One such non-surgical method involves using standardized, custom-made oral sleep appliances to progressively advance and / or protrude the mandible (lower jaw) relative to the upper jaw (upper jaw). These standardized appliances, often referred to as mandibular advancement devices (“MADs”), typically consist of an upper dental tray and a lower dental tray, wherein the lower dental tray is designed to advance the mandible and, consequently, move the tongue forward to increase space in the posterior portion of the pharynx and oropharynx, which in turn can be used to increase airflow during sleep. The distance (advancement) required for mandibular protrusion and / or repositioning can depend at least in part on the severity of an individual's obstructive sleep apnea and the user's psychological variables.

[0005] Orthodontic treatment using progressive aligners is known for correcting misaligned teeth and thus, for example, a patient's bite and smile line. MADs have a progressive mechanism that pulls the mandible forward and allows the tongue to move away from the back of the throat, increasing the volume of air exchanged. One unintended consequence of MAD treatment is tooth shift, particularly of the upper and lower anterior teeth. Patients who have successfully used MADs may develop malocclusions in their dentition, forcing them to choose between discontinuing treatment that is essentially saving them from nocturnal hypoxia episodes or continuing MAD treatment while their teeth continue to be misaligned and their bite gradually deviates from its once-normal position. Furthermore, using MADs during sleep can prevent patients from initiating an alignment program, as the aligner cannot be used during sleep.

[0006] Therefore, it would be beneficial to have devices and methods that facilitate the simultaneous use of MAD and progressive aligners. Summary of the Invention

[0007] In one aspect, this disclosure relates to a support for an oral alignment appliance. The support may include: a one-piece body having a front end and a rear end; a rear protrusion connected to the rear end; and a front protrusion connected to the front end. The front protrusion and the rear protrusion may each have a spherical segment shape.

[0008] In another aspect, this disclosure relates to an oral alignment appliance for simultaneously treating sleep apnea and aligning a user's dentition. The oral alignment appliance may include: an upper alignment tray configured to receive the user's upper teeth; and a lower alignment tray configured to receive the user's lower teeth. Each of the upper and lower alignment trays may have a first female housing located on a first side of the alignment tray and a second female housing located on an opposite side of the alignment tray. The oral alignment appliance may also include a pair of pillars pivotally connected to each of the upper and lower alignment trays. Each pillar may include a body, a posterior projection, and a posterior projection, wherein each of the posterior and posterior projections is removably connected to a corresponding female housing, and each of the posterior and posterior projections has a spherical segment shape.

[0009] In another aspect, this disclosure relates to a method for forming and / or using an oral alignment appliance according to this disclosure. The method includes: making an impression of a user's dentition and manufacturing one or two of a series of upper alignment trays and lower alignment trays (upper and lower dental arches) for treating sleep apnea while progressively aligning the user's dentition. The method further includes: removably attaching a first pillar to each of a first upper alignment tray and a first lower alignment tray; removing the first pillar from one or both of the first upper alignment trays and the first lower alignment trays; and replacing at least one of the first pillar, the first upper alignment tray, and the first lower alignment tray with a corresponding at least one of a second pillar, a second upper alignment tray, and a second lower alignment tray. The method may further include: reassembling the oral alignment appliance with the second pillar, the second upper alignment tray, and the second lower alignment tray as part of progressively aligning the dentition or treating sleep apnea. Attached Figure Description

[0010] A more specific description will be presented by reference to specific embodiments illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments and therefore should not be considered as limiting their scope. Exemplary embodiments will be described and explained with additional specificity and detail using the drawings, in which: Figure 1 This is a perspective view of an exemplary oral appliance according to one embodiment; Figure 2 yes Figure 1 A top view of oral appliances; Figure 3 yes Figure 1 A side view of oral appliances; Figure 4 This is a bottom view of an exemplary top-aligned tray according to one embodiment; Figure 5 This is a bottom view of an exemplary bottom-aligned tray according to one embodiment; Figure 6 This is a top left perspective view of an exemplary pillar according to one embodiment; Figure 7 yes Figure 6 Front view of the pillar; Figure 8 This is a partially exploded view of an exemplary oral appliance according to one embodiment; Figure 9 This is a front view of an exemplary female seat according to one embodiment; and Figure 10 This is a right perspective view of an oral appliance in the open position according to one embodiment.

[0011] Various features, aspects, and advantages of the embodiments will become more apparent from the following detailed description and the accompanying drawings, wherein the same numbers denote the same parts throughout the drawings and text. The various features described are not necessarily drawn to scale, but are drawn to emphasize specific features relevant to some embodiments.

[0012] The headings used herein are for organizational purposes only and are not intended to limit the scope of the specification or claims. For ease of understanding, reference numerals have been used where possible to designate common elements in the drawings. Detailed Implementation

[0013] For the purpose of illustrating the features of the embodiments, an example is now introduced and referenced throughout this disclosure. Those skilled in the art will recognize that this example is illustrative and not restrictive, and is provided for purposes of explanation only.

[0014] In one aspect, this disclosure relates to an oral appliance for the temporary treatment of sleep apnea while simultaneously performing progressive dental alignment. For example, Figures 1-3 An exemplary oral appliance (sometimes simply referred to herein as an "oral appliance" or "appliance") 100 is illustrated, generally comprising a first (i.e., upper) plate / tray 102 and a second (i.e., lower) plate / tray 104 in a facing relationship. The upper tray 102 and lower tray 104 each include a corresponding rear end (or portion) along the rear end (or portion) 106 of the appliance 100 and a corresponding front end (or portion) along the front end (or portion) 108 of the appliance 100. The first tray 102 and the second tray 104 may be available in various standard / general-purpose sizes (similar to sports mouthguards), such as small, medium, large, or extra-large. The selected size may be based on the individual patient's jaw dimensions, which helps to provide a comfortable fit with the patient's dentition (i.e., the configuration of teeth and gums). As those skilled in the art will understand, the appliance 100 is intended to be worn on a user's teeth such that the upper tray 102 accommodates the user's upper teeth and the lower tray 104 accommodates the user's lower teeth. On one hand, the upper tray 102 and the lower tray 104 can be shaped to conform to the patient's teeth and / or designed to progressively align (i.e., shift) the patient's teeth as is known.

[0015] The device 100 can be adjusted such that the lower tray 104 is offset relative to the upper tray 102 to maintain the user's mandible in a protruding (i.e., forward-push) position according to the treatment protocol for sleep apnea. For example, the lower tray 104 can be pushed forward (i.e., offset) by a distance of 10 mm or greater (e.g., in increments of up to about 0.5 mm), for example, from about 2 mm to about 5 mm, for example, about 3.5 mm. Pushing the mandible forward helps to advance the patient's mandible and move the tongue forward, thereby increasing the space in the posterior portion of the patient's throat and oropharynx to increase airflow during the patient's sleep.

[0016] An exemplary appliance 100 includes a pair of pillars or pillar assemblies 112, which are pivotally (e.g., rotatably) connected to an upper tray 102 and a lower tray 104 at respective upper (i.e., rear) and lower (i.e., front) joints or hinges 114, 116, the joints or hinges being, for example, ball joints (e.g., ball / socket joints), positioned along opposite sides of the appliance 100. When the upper tray 102 and lower tray 104 are in a closed position, according to Figures 1-3 The exemplary appliance 100 shown has a support assembly 112 that extends generally along the outside of the lower tray 102 and turns upward to extend to the upper tray 104.

[0017] Figure 4 and Figure 5 Examples are respectively illustrated for use in oral appliances according to this disclosure and as generally shown in Figures 1-3 Exemplary embodiments of the upper alignment tray 204 and lower alignment tray 202 shown are illustrated. For the purposes of this disclosure, "alignment tray" refers to an orthodontic aligner for progressive correction of misalignment, etc., as is known. Figure 4 and Figure 5 In the exemplary embodiment shown, the upper alignment tray 204 and the lower alignment tray 202 can be configured to sequentially detach with the progressively removable arm—that is, the strut 300 ( Figures 6-8 —Together. Each upper alignment tray and / or lower alignment tray, individually or as an upper / lower alignment tray pair, may be used for a recommended period of many days (typically 7-14 days), after which one or more trays may be replaced with the next set to correct pre-existing malocclusion or teeth that have moved during prescription use of mandibular advancement devices for the treatment of obstructive sleep apnea. For example, in the exemplary embodiment, the upper alignment tray 204 and lower alignment tray 202 each have a base 206 attached to each side.

[0018] More specifically, the upper alignment tray 204 may include a female base 206a having a base 208a and a female base 206b having a base 208b, and the lower alignment tray 202 may include a female base 206c having a base 208c and a female base 206d having a base 208d. Therefore, when worn by a user, a first support (e.g., support 300) may be connected between the female base 206a and the female base 206d, and a second support may be connected between the female base 206b and the female base 206c (see example...). Figure 8 ).

[0019] The female base 206 can be placed on the buccal side of the upper alignment tray 204 and the lower alignment tray 202. Furthermore, the female bases 206a and 206b of the upper alignment tray 204 can be positioned distally relative to the female bases 206c and 206d of the lower alignment tray 202. In several embodiments, the female bases 206a and 206b of the upper alignment tray 204 can be placed between or adjacent to one or more maxillary molars (e.g., the first, second, or third molars), and the female bases 206c and 206d of the lower alignment tray 202 can be placed between or adjacent to one or more mandibular molars (e.g., the first molar) or premolars (e.g., the first or second premolar). For example, the female bases 206a and 206b can be positioned between the second and third molars, and the female bases 206c and 206d can be positioned adjacent to the first molar. In the illustrated embodiment, females 206a and 206b are positioned adjacent to the second molar, and females 206c and 206d are positioned between the second premolar and the first premolar.

[0020] The attachment area of ​​the female connector 206 will have a relatively thick base 208 to prevent the female connector 206 from detaching from the tray during gradual replacement of the post 300 or due to mandibular protrusion (at least partially). Furthermore, the base 208 of the female connector 206 can be customized based on the user's dentition to ensure robust attachment that aligns the female connector 206 for receiving the post (e.g., post 300) while maintaining minimal discomfort to the user. Therefore, by combining robust attachment and proper alignment of the female connector 206, the protrusion of the female connector 206 away from the buccal surface of the teeth can be minimized to maintain a comfortable fit when worn by the user. When the female connector 206 (e.g., female connectors 206c, 206d) is positioned between the teeth, the base 208 (e.g., bases 208c, 208d) can have a wedge shape to properly align the female connector for receiving the post. Similarly, when the female base 206 (e.g., female bases 206a, 206b) is positioned adjacent to a tooth, the base 208 (e.g., bases 208a, 208b) may have a concave shape to properly align the female base for receiving the support post. As described in more detail below, dental scans and / or impressions may be used in conjunction with manufacturing techniques (e.g., 3D printing) to adapt to the user's dentition and achieve proper positioning and comfortable fit of the female base 206. In several embodiments, the upper alignment tray 204 and the lower alignment tray 202 may be worn by the user without the support post, such as when the user is awake. Therefore, regardless of whether the support post is installed, the shape of the female base 206 can be configured to promote a comfortable fit while minimizing user discomfort. For example, the edges and corners of the female base may be rounded.

[0021] refer to Figure 8 An exemplary (representative) configuration of the oral appliance according to this disclosure is a combined oral appliance and orthodontic aligner 200 (“alignment appliance”) shown generally in a partially exploded view. While the upper tray (204) and lower tray (202) are shown as not having dental impressions or other conformances, it should be understood that... Figure 8 A general configuration of an oral appliance according to the present disclosure is shown, including an oral alignment appliance, wherein an upper alignment tray 204 and a lower alignment tray 202 can be used in the alignment appliance 200 with a strut 300 (i.e., a progressively detachable arm).

[0022] On one hand, once an impression of the dentition is taken, an exemplary method for forming and / or using custom-made devices will provide the patient with a series of pre-determined custom-made sleep appliance trays (upper and lower dental arches), wherein the patient will wear each aligner / tray for a period of time—for example, approximately 10 days—before moving to the next set of trays. Throughout, the patient's mandible is projected based on its therapeutically forward position, as instructed by their sleep healthcare professional. The projection of the mandible is achieved by replacing removable struts 300, which are provided with a measurement of 0.5 mm. Specifically, each strut 300 can be positioned at both ends (302, 304 ( Figure 6 and Figure 7 The device disconnects from its attached (discussed further below) female 206 on each of the upper alignment tray 204 and lower alignment tray 202. Progressive orthodontic alignment during OSA treatment eliminates any unnecessary gaps or delays in OSA treatment, which can be life-saving. Patients who genuinely desire orthodontic alignment correction do not need to delay the start of OSA treatment, as both treatments are combined in one device.

[0023] The alignment device 200 according to this disclosure can be worn during non-sleep periods without the attachment strut 300. The nut 206 on each side of the upper alignment tray 204 and the lower alignment tray 202 may have a circular geometry to reduce or eliminate discomfort when wearing the alignment device during non-sleep periods.

[0024] Figure 6 and Figure 7 An exemplary pillar 300 is shown independently. Figure 6 and Figure 7 The same support 300 is shown in the corresponding top view, left perspective view, and front view. It should be understood that the corresponding supports 300 on opposite sides of the tray will be configured as mirror images of each other.

[0025] The various parts of the alignment appliance 200 can generally be made of materials suitable for use in the oral cavity, including, for example, stainless steel or any other surgical-grade metal alloy, or any biocompatible non-metallic material (including BPA-free materials), such as polymeric materials (i.e., polymers). For example, the tray can be made of a polymeric material (such as polypropylene) having a Shore hardness of about 60 to about 70. The various parts of the support 300 can also be made of polymeric materials (such as polycarbonate or polyester).

[0026] The various parts of the alignment device 200 can also be manufactured in any suitable manner, for example, using injection molding, 3D printing, or any other suitable technique known in the art and consistent with this disclosure. In one aspect, the various parts of each alignment tray 202, 204 and strut 300 can be made of a malleable material (such as a polymeric material, e.g., a polymer), such that, for example, each tray can be integrally molded with a mating seat in a desired location, and the body 301 and protrusions 303, 305 of each strut 300 can be integrally molded to the desired length and configuration. The one-piece components, which can be mechanically fitted together without fasteners or other parts, eliminate the need for screws, brackets, or other parts that may loosen and / or be accidentally lost or swallowed if not handled with extreme care. The interchangeability of the progressive components also allows for routine adjustments to sleep apnea treatment, alignment, or either.

[0027] As understood by those skilled in the art, orthodontic aligners are manufactured to fit a patient's teeth. The aligner is positioned on the teeth and held in place by specially designed fasteners or protruding elements (not shown) attached to the patient's teeth. The aligner is replaced periodically (e.g., every two weeks). As the aligner is progressively replaced, the teeth move into alignment. For use with the alignment appliance 200 discussed herein, the orthodontic aligner is manufactured, for example, typically using a vacuum forming process. According to an exemplary embodiment of this disclosure, a method for forming and using the alignment appliance 200 includes forming the orthodontic aligner (i.e., the upper alignment tray 204 and the lower alignment tray 202) and removably assembling the trays to the struts 300, as discussed further below. After orthodontic treatment is completed using a particular tray and / or strut, the existing tray and strut can be removed, and a new combination of one or two trays with a new strut can be obtained and assembled in the same manner. This process can be performed by a dentist, for example, every two weeks, as the aligner is replaced with a new aligner. This technique can be used, for example, for smile line correction in patients who wish to improve the alignment of their teeth, or to restore chewing function during treatment using oral appliances.

[0028] An exemplary support column 300—without limitation—may have a one-piece construction including a one-piece body 301. The one-piece body 301 may be formed of a polymer material. According to one aspect, the one-piece body 301 includes a front end 302 and a rear end 304. Additionally, the one-piece body 301 may include a bend between 80 and 100 degrees (such as 90 degrees). The portion of the one-piece body 301 between the bend and the front end 302 may be referred to as a front segment, and the portion of the one-piece body 301 between the bend and the rear end 304 may be referred to as a rear segment. In several embodiments, the length of the rear segment may be less than the length of the front segment. Additionally, the inner and / or outer corners of the bend may be rounded to facilitate a comfortable fit for the user. The one-piece body 301 may have a substantially uniform thickness along its entire length (e.g., between the front end 302 and the rear end 304). According to one aspect, the length of the support column 300, as measured between the front end 302 and the rear end 304, may be between approximately 20 millimeters (mm) and 30 millimeters (mm). According to one aspect, the length is approximately 25 mm. According to another aspect, the length is 25.3 mm. In some embodiments, the length of the front section of the one-piece body can be between 15 mm and 30 mm, and the length of the rear section of the one-piece body can be between 5 mm and 20 mm. In one embodiment, the length of the rear section can be between one-fifth and three-fifths of the length of the front section. For example, the length of the rear section can be half the length of the front section.

[0029] The rear protrusion 305 is connected to the rear end 304. The rear protrusion 305 may be integrally and monolithically formed with the integral body 301. In some embodiments, the entire support column 300 may be integrally and monolithically formed. According to one aspect, the rear protrusion 305 has a maximum outer diameter (MOD), which allows the rear protrusion 305 to be secured or retained in the female seat 206. Continuing to refer to... Figure 6 and Figure 7 And additionally refer to Figure 9 and Figure 10 When the rear protrusion 305 is secured in the female seat 206, it can rotate up to a full 360 degrees, allowing the upper alignment tray 204 and the lower alignment tray 202 to rotate from a first position where the trays are adjacent (e.g., Figure 1 and Figure 8 (As shown) Move to the second position where the tray is separated (as shown) Figure 10 As shown in the figure.

[0030] The front protrusion 303 is connected to the front end 302, and its configuration and function are as described for the rear protrusion 305. For the sake of brevity, those aspects will not be repeated.

[0031] Refer again Figure 6 and Figure 7The front protrusion 303 and the rear protrusion 305 each include a pair of opposing planar surfaces 318a, 318b, such that the front protrusion 303 and the rear protrusion 305 have the shape of a sphere cut by two parallel planes, i.e., they are formed into spherical segments. The front protrusion 303 and the rear protrusion 305 can be connected to the front end 302 and the rear end 304, respectively, at a tapered segment 320. For example, the front protrusion 303 can be connected to the front end 302 at a first tapered segment, and the rear protrusion 305 can be connected to the rear end 304 at a second tapered segment. The tapered segment 320 can improve user comfort, such as by reducing the pinch point between the support and the alignment tray. In some embodiments, the front protrusion 303 and the rear protrusion 305 can be removably connected to the front end 302 and the rear end 304, respectively.

[0032] According to one aspect, the integral body 301, the rear protrusion 305, and the front protrusion 303 are integrally formed. For example, the support column 300 can be a 3D printed structure. The support column 300 can be 3D printed from polymer materials.

[0033] refer to Figure 8 and Figure 9 The lower alignment tray 202 and the upper alignment tray 204 each include two females 206 on opposite sides. The female on the lower alignment tray 202 is positioned further forward than the female on the upper alignment tray 204 to create an offset (or protrusion distance) prescribed by the dentist. In other words, the alignment appliance 300 is configured to position the user's mandible in a direction forward from the user's natural jaw position to aid in the treatment of the user's sleep apnea. The optimal jaw position for the user can be determined by the dentist and prescribed to the laboratory responsible for manufacturing the oral appliance 300.

[0034] The female base 206 extends outward from the opposite sides of the upper alignment tray 204 and the lower alignment tray 202. The female base 206 serves as a bearing, allowing the struts 300 to move freely when the front protrusion 303 and the rear protrusion 305 are secured in their respective female bases 206. A pair of female bases 206 on the upper alignment tray 204 can be positioned at defined or constant locations on the upper alignment tray 204, serving as reference points for any desired changes in the protrusion distance that may be required on the lower alignment tray 202. Similarly, the length of each strut 300 can also be constant. Each female base 206 includes a circular opening 712 with an inner diameter ID.

[0035] The envisioned approach is that the alignment trays 202 and 204 will be shaped from a three-dimensional (3D) scan of the user's upper and lower teeth. For example, a lab technician would incorporate the female base 206 into a computer-aided design (CAD) model. The technician would then output a file for 3D printing using one of several methods. As described above, the female base 206 on the upper alignment tray 204 can be used as a reference plane from which the position of the female base 206 on the lower tray 202 is measured.

[0036] The female seat 206 on the lower alignment tray 202 is positioned forward relative to the female seat 206 on the upper alignment tray 204. According to one aspect, adjustments made to the relative position of the female seat 206 on the lower alignment tray 202 affect the projection distance of the user's jaw. This means that the dentist can specify the desired projection distance, and only the lower alignment tray 202 will need to be modified or replaced according to the user's needs.

[0037] Each female seat 206 according to an exemplary embodiment is configured to receive a protrusion 303, 305 of the corresponding support 300. The female seat 206 may include a slit, slot, or gap 710 that facilitates entry of the protrusion into the female seat 206. According to one aspect, the protrusions 303, 305 are removably coupled to the corresponding female seat 206 by placing the protrusions 303, 305 into the female seat 206. The slot 710 may have a predetermined (or constant) width and may be configured to allow the protrusions 303, 305 to be attached to the female seat 206. The geometry of the protrusions 303, 305 and the alignment trays 202, 204 may be designed such that, after the support 300 is assembled with the alignment trays 202, 204, when the alignment device 200 is in the user's mouth, the support 300 will not disengage or detach from the alignment trays 202, 204. If it is determined that a different offset is necessary for a particular user, then the lower alignment tray 202 with the modified offset may be the only tray that needs to be manufactured. However, any one or all of the upper alignment tray 204, the support 300, and the lower alignment tray 202 may be remanufactured or replaced with a different size or configuration for reasons affecting offset and alignment functionality or for another reason, such as wear.

[0038] In one aspect of the exemplary embodiment, each of the females 206 on the alignment device 200 has a substantially identical configuration and interaction with the corresponding protrusions 303, 305 of the struts 300. Similarly, each of the struts 300 has a substantially identical configuration, including for each of the protrusions 303, 305. The opening 712 of the female 206 and the corresponding protrusions 303, 305 are shaped and sized to be "keyed" to each other. That is, the protrusions 303, 305 can only be inserted into the corresponding female 206 when they are properly aligned (i.e., in "shape alignment") with the gaps 710 of the corresponding female 206. Specifically, in the illustrated embodiment, each protrusion 303, 305 can only be inserted into the corresponding female 206 when the planar portions / surfaces 318a, 318b of the protrusions 303, 305 are aligned with the gaps 710 in the female 206. Therefore, it should be understood that the dimensions of the female seat 206 may be substantially the same as the dimensions of the protrusions 303, 305. In some embodiments, the dimensions of the protrusions 303, 305 may be slightly larger than certain corresponding dimensions of the female seat 206 to provide a "click" engagement when the support post 300 is connected.

[0039] To attach each support 300 to each of the alignment trays 202, 204 (after selecting a support 300 of appropriate length), the support 300 must be oriented approximately perpendicular to the plane of the tray, such that the tray can be rotated vertically (e.g., at a 90-degree angle to the socket 206) to bond the protrusion to the socket via gap 710. Once the protrusion is removably connected to the corresponding socket, the tray can then be returned to its horizontal position, so that the support 300 and the tray are removably secured to each other. This process can be performed one tray at a time. As described above, the protrusions 303, 305 can be sized to snap into the socket 206 if desired. If further adjustments are required, the above process can be reversed to remove the support 300, etc.

[0040] As discussed above, once the support 300 has been set to the desired length and attached to the alignment trays 202, 204, the mandible is in a fixed position relative to the maxilla. Therefore, while the joint allows for some lateral and vertical movement of the lower alignment tray 202 relative to the upper alignment tray 204 to accommodate typical jaw movements, it prevents the mandible from moving away from the necessary treatment position in a retracted (i.e., posterior) direction. Lateral movement of the lower alignment tray 202 relative to the upper alignment tray 204 can be between 4 mm and 10 mm on each side towards the facial midline. Vertical movement of the lower alignment tray 202 relative to the upper alignment tray 204 can be between 2 mm and 8 mm for the user's habitual bite. In one embodiment, vertical movement of the lower alignment tray 202 relative to the upper alignment tray 204 can facilitate vertical movement between the occlusal surfaces of the alignment trays between 0 mm and 6 mm. In some embodiments, the thickness of the trays can be between 0.5 mm and 2 mm, for example, 1 mm.

[0041] The strut 300 is configured to position the upper alignment tray 204 and the lower alignment tray 202 in an offset configuration, such that the user's mandible is pushed forward relative to the user's upper teeth. On one hand, the alignment appliance 200 can be configured such that adjusting the position of the matte 206 on the lower alignment tray 202 forward or backward affects the extent of protrusion obtained by the user's mandible. On the other hand, the strut 300 can be replaced with struts of different lengths. The alignment appliance is generally configured to provide both sleep apnea treatment and alignment functions simultaneously.

[0042] In other aspects of several embodiments, the geometry of the female seat 206 may include a canter angle of approximately 6 degrees relative to the horizontal plane to facilitate increased movement of the strut 300 while maintaining engagement of the protrusions 303, 305 with the female seat 206. It is envisioned that other canter angles besides 6 degrees may be specified based on the contour curve of the patient's jaw. Some patients have a wider, more elliptical bend, while others have a sharper V-shaped bend. For example, the canter angle may be between 1 and 8 degrees, or between 4 and 8 degrees.

[0043] The positioning of the female bracket 206 on the corresponding alignment trays 202, 204 can be based on the dentist's prescribed treatment plan. The outward inclination angles of the protrusions 303, 305 can be parallel to the corresponding outward inclination angle of the corresponding female bracket 206. This ensures that the maximum articulation movement of the lower alignment tray 202 relative to the upper alignment tray 204 (e.g., when the user's mandible is laterally translated) is up to approximately 8 mm. It is envisioned that since the support 300 can articulate between both the upper and lower alignment trays 202 and 204, there is no jamming or restricted movement of the support 300, and thus the possibility that excessive forces on the support 300 might potentially lead to its failure is reduced. Failure can be defined as permanent deformation, fracture, or breakage of the support 300 due to forces applied to it.

[0044] According to one approach, the position of the pedicle 206 can be adjusted through incremental changes, such as based on the user's jaw anatomy. For example, the incremental change could be in increments of 0.5 mm. More precisely, the change could be in fractions of a millimeter or larger increments, based on the dentist's judgment. According to one approach, incremental changes can facilitate offsets up to approximately 10 mm. Incremental changes can facilitate offsets greater than 10 mm or greater than 15 mm, all depending on the dentist's prescribed treatment for the patient.

[0045] It is envisioned that one or more sensors (not shown) may be positioned on or housed within at least one of the upper alignment tray 204 and the lower alignment tray 202. These sensors may be used to collect physiological data and, in some cases, monitor and diagnose obstructive sleep apnea (OSA). In some cases, the sensors may also be able to provide therapy to treat OSA. It is envisioned that any captured physiological data may be used to monitor the effectiveness of prescribed therapy, as well as as a trigger for initiating OSA treatment. Such sensors may include, for example, accelerometers / gyroscopes, oral microphones, piezoelectric pressure sensors, oxygen sensors, and wireless electroencephalography (EEG).

[0046] According to one approach, custom-made dental appliances can be manufactured through digital scanning of a patient's jaw / dental arch or using conventional impression molds. Clear retainer-type aligners can be manufactured using known techniques. After scanning or capturing the dentition using impression material, the laboratory will fabricate custom-made dental appliance alignment trays (e.g., upper and lower trays), which may include a cured and / or adhered liner that can be inserted onto a pre-fabricated progressive alignment tray.

[0047] This disclosure includes, in various embodiments, configurations, and aspects, generally developed components, methods, processes, systems, and / or apparatuses as depicted and described herein, including various embodiments, sub-combinations, and subsets thereof. Those skilled in the art will understand how this disclosure will be made and used after understanding it. This disclosure includes, in various embodiments, configurations, and aspects, providing apparatuses and processes in the absence of items not depicted and / or described herein or in any of its various embodiments, configurations, or aspects, including in the absence of items that may have already been used in prior apparatuses or processes, for example, to improve performance, achieve ease of implementation, and / or reduce implementation costs.

[0048] The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both operationally connective and disjoint. For example, each of the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” means a single A, a single B, a single C, A and B together, A and C together, B and C together, or A, B, and C together.

[0049] In this specification and the appended claims, several terms will be used with the following meanings. The terms “a” (or “an”) and “the” refer to one or more of the entity, thus including plural referents, unless the context clearly specifies otherwise. Thus, the terms “a” (or “an”), “one or more”, and “at least one” are used interchangeably herein. Furthermore, references to “an embodiment,” “some embodiments,” “an embodiment,” etc., are not intended to be construed as excluding the existence of additional embodiments that also include the described features. Approximate language, as used herein throughout the specification and claims, may be applied to modify any quantitative expression that may vary permissibly without causing a change in the essential function associated with it. Therefore, values ​​modified by terms such as “about” are not limited to specified precise values. In some cases, approximate language may correspond to the precision of the instrument used to measure the value. Terms such as “first,” “second,” “upper,” “lower,” etc., are used to distinguish one element from another and are not intended to refer to a particular order or number of elements unless otherwise specified. All directional references (e.g., "up", "down", "upward", "downward", "left", "right", "leftward", "rightward", "top", "bottom", "above", "below", "vertical", "horizontal", "clockwise", and "counterclockwise") are used for identification purposes only to help the reader understand the various embodiments of the invention and do not create limitation, in particular, with respect to the location, orientation, or use of the invention, unless specifically set forth in the claims.

[0050] As used herein, the terms “may” and “may be” indicate the likelihood of an event occurring in a set of circumstances; the possession of a specified attribute, characteristic, or function; and / or the limitation of one verb by expressing one or more of the abilities, talents, or possibilities associated with the verb being limited. Thus, the use of “may” and “may be” indicates that the modified term is clearly appropriate, capable, or suited for the indicated ability, function, or purpose, while taking into account that in some cases the modified term may not be appropriate, capable, or suited. For example, in some cases an event or ability may be expected, while in others it may not be possible—this distinction is captured by the terms “may” and “may be.”

[0051] As used in the claims, the word "comprising" and its grammatical variations logically also cover and include different and varying degrees of phrases, such as, but not limited to, "consistently of..." and "consisting of...". Where necessary, scopes have been provided, and those scopes include all subscopes between them. It is anticipated that variations in these scopes will be apparent to those skilled in the art, and that the appended claims should cover those variations in the absence of public disclosure.

[0052] As used herein, the terms “determine,” “calculate,” “compute,” and their variations may be used interchangeably and include any type of methodology, process, mathematical operation, or technique.

[0053] The foregoing discussion of this disclosure has been presented for illustrative and descriptive purposes. The foregoing is not intended to limit this disclosure to the one or more forms disclosed herein. For example, in the foregoing detailed description, various features of this disclosure are grouped together in one or more embodiments, configurations, or aspects for the purpose of streamlining the disclosure. Features of embodiments, configurations, or aspects of this disclosure may be combined in alternative embodiments, configurations, or aspects other than those discussed above. This approach to disclosure should not be construed as reflecting an intention that this disclosure claims more features than are expressly recited in each claim. Rather, as reflected in the following claims, the claimed features comprise fewer than all features of a single foregoing embodiment, configuration, or aspect. Therefore, the following claims are incorporated herein by reference, wherein each claim is independently a separate embodiment of this disclosure.

[0054] Advances in science and technology may make possible equivalents and alternatives that are not currently conceived due to the imprecision of language; these variations should be covered by the appended claims. This written description uses examples to disclose methods, machines, and computer-readable media, including best practices, and also enables any person skilled in the art to practice these contents, including making and using any device or system and performing any incorporated methods. Its patentable scope is defined by the claims and may include other examples that would occur to a person skilled in the art. Such other examples are intended to fall within the scope of the claims if they have structural elements that are indistinguishable from the literal language of the claims, or if they include equivalent structural elements that are not substantially different from the literal language of the claims.

Claims

1. A support for an oral alignment appliance, the support comprising: A one-piece body, the one-piece body being formed of a polymer material, the one-piece body having a front end and a rear end; A rear protrusion, the rear protrusion being connected to the rear end; as well as A front protrusion, which is connected to the front end. The front protrusion and the rear protrusion are each formed into a spherical segment.

2. The support pillar according to claim 1, wherein, The posterior protrusion and the anterior protrusion are respectively configured for removable connection to the corresponding female of the oral alignment appliance.

3. The support pillar according to claim 1, wherein, The rear protrusion is connected to the rear end at the first tapered section, and the front protrusion is connected to the front end at the second tapered section.

4. The pillar according to any one of claims 1 to 6, wherein, The rear protrusion and the front protrusion are integrally and integrally formed with the integral body.

5. The pillar according to any one of claims 1 to 7, wherein, The unibody structure includes a bend between 80 and 100 degrees.

6. The support pillar according to claim 5, wherein, The bend is 90 degrees.

7. The pillar according to any one of claims 5 to 6, wherein, The length between the bend and the front end is greater than the length between the bend and the rear end.

8. The pillar according to any one of claims 5 to 7, wherein, The curved outer corner is rounded.

9. An oral alignment appliance for simultaneously treating sleep apnea and aligning the dentition of a user, the oral alignment appliance comprising: Upper alignment tray, the upper alignment tray being configured to receive the user's upper teeth; A first female connector, positioned on a first side of the upper alignment tray, and a second female connector, positioned on the opposite side of the upper alignment tray; Lower alignment tray, the lower alignment tray being configured to receive the user's lower teeth; A first female connector, positioned on a first side of the lower alignment tray, and a second female connector, positioned on the opposite side of the lower alignment tray; and A pair of pillars, pivotally connected to each of the upper and lower alignment trays, wherein each pillar includes a body, a rear protrusion, and a front protrusion, wherein each of the rear and front protrusions is removably connected to a corresponding female seat, and Each of the front protrusion and the rear protrusion is shaped as a spherical segment.

10. The oral alignment appliance according to claim 9, wherein, Each female part has the same size, and each of the front protrusions and the rear protrusions has the same size.

11. The oral alignment appliance according to claim 10 or claim 9, wherein, Each of the upper and lower alignment trays is replaceable as part of the alignment user's dentition.

12. The oral alignment appliance according to any one of claims 9 to 11, wherein, The first female seat located on a first side of the upper alignment tray includes a first base having a first wedge shape, and the second female seat located on the opposite side of the upper alignment tray includes a second base having a second wedge shape.

13. The oral alignment appliance according to any one of claims 9 to 12, wherein, The first female seat located on the first side of the lower alignment tray includes a first base having a first concave shape, and the second female seat located on the opposite side of the upper alignment tray includes a second base having a second concave shape.

14. The oral alignment appliance according to any one of claims 9 to 11, wherein, The first female seat located on a first side of the upper alignment tray includes a first base having a first concave shape, and the second female seat located on the opposite side of the upper alignment tray includes a second base having a second concave shape.

15. The oral alignment appliance according to any one of claims 9 to 12, wherein, The first female seat located on the first side of the lower alignment tray includes a first base having a first wedge shape, and the second female seat located on the opposite side of the upper alignment tray includes a second base having a second wedge shape.

16. A method for forming and / or using an oral alignment appliance, the oral alignment appliance comprising a strut according to any one of the preceding claims, the method comprising: To make an impression of the user's teeth; Manufacture one or both of a series of upper alignment trays and lower alignment trays for the treatment of sleep apnea while progressively aligning the user's dentition; The first pillar is removably connected to each of the first upper alignment tray and the first lower alignment tray; Remove the first support from one or both of the first upper alignment tray and the first lower alignment tray; At least one of the first pillar, the first upper alignment tray, and the first lower alignment tray is replaced with at least one of the corresponding second pillar, the second upper alignment tray, and the second lower alignment tray, and the oral alignment appliance is reassembled with at least one of the second pillar, the second upper alignment tray, and the second lower alignment tray as part of progressive alignment of the dentition or treatment of sleep apnea.

17. The method according to claim 16, wherein, The removal and replacement steps occur gradually over a predetermined time period.

18. The method according to claim 16 or claim 17, wherein, The patient's mandible is protruded based on its therapeutic forward position, and this protrusion is achieved by replacing the first pillar with a second pillar whose length differs from that of the first pillar by approximately 0.5 mm.

19. The method according to any one of claims 16 to 18, wherein, The oral alignment appliance is reassembled by removing the first post by disconnecting one or both of the anterior or posterior protrusions from their corresponding females on the lower or upper alignment tray, and by removably connecting the first or second post to their corresponding females on the second lower or upper alignment tray.

20. The method according to claim 19, wherein, Each of the female supports has the same size, the second pillar has a front protrusion and a rear protrusion, and each of the front and rear protrusions on each of the first and second pillars has the same size as the other protrusions.

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