MANDIBULAR REPOSITIONING APPLIANCES AND METHODS OF MANUFACTURING THE SAME

Abstract

Methods of repositioning a mandible of an individual include acquiring a digital model of a dentition and/or a craniofacial anatomy of the individual, the digital model including a representation of a condyle or an incisal guidance or both the condyle and the incisal guidance. The method also includes calculating, based on the digital model, a slope of the condyle or a slope of the incisal guidance or both the slope of the condyle and the slope of the incisal guidance, and fabricating at least one removable orthodontic appliance including a feature configured to constrain a posterior or anterior movement of the mandible relative to the maxilla when worn by the individual, wherein a position of the feature is determined based on the slope of the condyle or the slope of the incisal guidance or both the slope of the condyle and the slope of the incisal guidance.

Claims

1. A method of repositioning a mandible of an individual, the method comprising: acquiring a digital model of a dentition and/or a craniofacial anatomy of the individual, the digital model including a representation of a condyle or an incisal guidance or both the condyle and the incisal guidance; calculating, based on the digital model, a slope of the condyle or a slope of the incisal guidance or both the slope of the condyle and the slope of the incisal guidance; and fabricating at least one removable orthodontic appliance including a feature configured to constrain a posterior or anterior movement of the mandible relative to the maxilla when worn by the individual, wherein a position of the feature is determined based on the slope of the condyle or the slope of the incisal guidance or both the slope of the condyle and the slope of the incisal guidance.

2. The method of claim 1, wherein the acquiring the digital model of the dentition and/or the craniofacial anatomy includes imaging using a radiographic imaging technique, an MRI technique, an ultrasound imaging technique and/or a direct intraoral scanning technique.

3. The method of claim 1, wherein the slope of the condyle is calculated using the equation m.sub.c=(y.sub.2−y.sub.1)/(x.sub.2−x.sub.1), wherein x.sub.1, x.sub.2, y.sub.1 and y.sub.2 are positional coordinates of the condyle.

4. The method of claim 3, wherein the positional coordinates of the condyle are determined based on input received from a user or automatically using a best fit algorithm applied to a geometry of the dentition and/or a craniofacial anatomy in the digital model.

5. The method of claim 1, wherein the slope of the incisal guidance is calculated using the equation m.sub.i=(y.sub.2−y.sub.1)/(x.sub.2−x.sub.1), wherein x.sub.1, x.sub.2, y.sub.1 and y.sub.2 are positional coordinates of the incisal guidance.

6. The method of claim 5, wherein the positional coordinates of the incisal guidance are determined based on input received from a user or automatically based on a best fit algorithm.

7. The method of claim 1, wherein the at least one removable orthodontic appliance is configured to mate with a geometry of a maxillary dentition and adjacent gum tissue of the individual.

8. The method of claim 1, wherein the fabricating at least one removable orthodontic appliance includes fabricating at least one complementary removable orthodontic appliance, wherein the at least one complementary removable orthodontic appliance is configured to mate with a geometry of a mandibular dentition and adjacent gum tissue of the individual and is configured to interact with the feature of the at least one removable orthodontic appliance to constrain the posterior or anterior movement of the mandible relative to the maxillae.

9. The method of claim 8, wherein the feature of the at least one removable orthodontic appliance includes a barb or hook element, and wherein the at least one complementary removable orthodontic appliance includes a complementary barb or hook element configured to removably engage with the barb or hook element of the at least one removable orthodontic appliance.

10. The method of claim 1, wherein the fabricating at least one removable orthodontic appliance includes fabricating a series of removable orthodontic appliances designed to reposition the mandible from an initial position relative to the maxillae to a new position relative to the maxillae, wherein the position of the feature of each subsequent appliance includes an incremental positional change relative to the positions of the feature of a prior appliance.

11. The method of claim 10, wherein a number of incremental positional changes and a size of each incremental positional change are determined based on user input.

12. The method of claim 10, wherein the fabricating the series orthodontic appliances includes fabricating, for each removable orthodontic appliance in the series, a complementary removable orthodontic appliance configured to mate with a geometry of a mandibular dentition and adjacent gum tissue of the individual and is configured to interact with the feature of the removable orthodontic appliance to constrain the posterior or anterior movement of the mandible relative to the maxilla.

13. The method of claim 1, wherein the at least one removable orthodontic appliance includes a clear aligner.

14. The method of claim 13, wherein the clear aligner is fabricated by 3-D printing.

15. The method of claim 13, wherein the feature is integral with the clear aligner.

16. The method of claim 13, wherein the feature is fabricated separately from the clear aligner and attached or secured to the clear aligner.

17. The method of claim 16, wherein the feature is fabricated on a thin substrate and where the fabricating includes adhering or bonding the thin substrate to the clear aligner.

18. A removable orthodontic appliance configured to reposition a mandible of an individual, the appliance comprising: a structure configured to mate with a geometry of a maxillary dentition and adjacent gum tissue of the individual; and a feature configured to constrain a posterior or anterior movement of the mandible relative to the maxilla when the appliance is worn by the individual, wherein the feature is located on the structure in a position based on a slope of a condyle of the individual or a slope of an incisal guidance of the individual or both the slope of the condyle and the slope of the incisal guidance.

19. The removable orthodontic appliance of claim 18, wherein the feature includes at least one ridge or shelf located proximal a lingual surface of the incisal guidance.

20. A removable orthodontic appliance pair configured to reposition a mandible of an individual, the appliance pair comprising: a first structure configured to mate with a geometry of a maxillary dentition and adjacent gum tissue of the individual, the first structure including a first feature located on an external surface of the first structure; and a second structure configured to mate with a geometry of a mandibular dentition and adjacent gum tissue of the individual; wherein the first feature is configured to constrain a posterior or anterior movement of the mandible relative to the maxillae when the appliance pair is worn by the individual, wherein the first feature is located on the first structure in a position based on a slope of a condyle of the individual or a slope of an incisal guidance of the individual or both the slope of the condyle and the slope of the incisal guidance.

21. The appliance pair of claim 20, wherein the first feature includes a barb or hook element, and wherein the second structure includes a second feature located on an external surface of the second structure, wherein the second feature includes a complementary barb or hook element configured to removably engage with the barb or hook element of the first feature.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The detailed description is described with reference to the accompanying figures. The use of the same reference numbers in different instances in the description and the figures may indicate similar or identical items.

[0016] FIG. 1 illustrates a method of repositioning a mandible of an individual according to an embodiment.

[0017] FIG. 2A illustrates a cross-sectional view of a mandibular condyle and zygomatic process of an individual;

[0018] FIG. 2B illustrates a cross-sectional view of a maxillary incisor of an individual;

[0019] FIG. 3A illustrates a cross-sectional view of an example of a mandible of an individual, including a representation of the condylar slope in relation to the incisal slope.

[0020] FIG. 3B illustrates a cross-sectional view of an example of a mandible of a different individual, including a representation of the condylar slope in relation to the incisal slope;

[0021] FIG. 4 illustrates a cross-sectional view of a maxillary appliance according to an embodiment, as worn by an individual; and

[0022] FIG. 5 illustrates a cross-sectional view of an appliance pair including removable maxillary appliance 50 and complementary removable mandibular appliance 55, according to an embodiment, as worn by an individual.

DETAILED DESCRIPTION

[0023] The present disclosure provides mandibular repositioning appliances and methods of manufacturing the same. The mandibular appliances of the present disclosure are advantageously customized based on the anatomical slopes of the patient's maxillary incisors and/or the articulating surface of the patient's mandibular condyles.

[0024] According to various embodiments, optimized dental appliances for repositioning of the individual's mandible relative to the maxilla and improving the individual's bite are designed according to the individual's unique craniofacial and dental anatomy to determine the coordinate changes in repositioning the mandible. The appliances contain the geometry of the dentition and adjacent gum tissues and may include constraining features designed to provide a biasing force created by the muscles of mastication when worn by the individual. For example, the constraining features may be configured to provide a biasing force that constrains a posterior or anterior movement of the mandible relative to the maxillae when worn by the individual.

[0025] In certain aspects, a series of removable appliances may be designed, with positional increments of biasing features to promote mandibular movement from an initial position to a new, desired position as directed by a dentist.

[0026] FIG. 1 illustrates a method of repositioning a mandible of an individual according to an embodiment. At step 1, a digital model of the dentition and/or a craniofacial anatomy of the individual is acquired. The unique craniofacial and dental anatomy may be obtained by imaging the individual's dentition and/or craniofacial anatomy using various imaging modalities such as radiographic, MRI, ultrasound or direct scanning technologies (e.g., via intra-oral scanning or scanning a mold of the individual's dentition). In certain aspects, the same imaging system is used to acquire an image of both the dentition and the craniofacial anatomy of the individual, for example radiographic imaging or cone-beam computed tomography (CBCT) or MRI or Ultrasound imaging or other imaging system may be used to acquire an image of the dentition and the craniofacial anatomy proximal the mandibular condyle.

[0027] It should be appreciated that different imaging technologies may be used to acquire images of the dentition and the craniofacial anatomy proximal the mandibular condyle. A common point or points in different images of the dentition and the craniofacial anatomy may be identified to facilitate image combination. For example, the digital model may a combination of a radiographic image of the condyle and an intra-oral scanned image of the dentition. Once the image or images are acquired, the image(s) may be stored to a memory of a computer or processing system and rendered on a display device for viewing by a dentist or other user. The digital model presented on the display device may include a representation of the mandibular condyle or an incisal guidance or both the condyle and the incisal guidance. FIGS. 2A, 2B, 3A and 3B show example representations that may be displayed on a display device. A user interface (UI) may be provided to allow the user to interact with the digital model presented on the display. For example, a mouse, pen, keyboard or other device may be used to enable control of a cursor or pointer or other user-interface elements and to enable selection of portions of the rendered digital model.

[0028] At step 2, a slope of the condyle or a slope of the incisal guidance or both the slope of the condyle and the slope of the incisal guidance are calculated based on the digital model. For example, in an embodiment, a slope is automatically calculated based on relevant points (positional coordinates) in the digital model of the condyle and/or incisor. The relevant points may be automatically determined or identified by the processing system or the relevant points may be identified or selected by a user, e.g., using the user interface to manually select points on the condyle and/or incisor from which to determine the slope(s). In some embodiments, the processing system may automatically determine and identify multiple points on the condyle and/or the incisor from which the user may select for use in determining the slope(s). In other embodiments, the processing system may automatically determine and identify multiple points on the condyle and/or the incisor and also automatically calculate the slope(s) using a best fit equation or algorithm taking the multiple points as input. In other embodiments, other equations or algorithms for determining or calculating the slope may be used as would be apparent to one skilled in the art.

[0029] FIG. 2A illustrates a cross-sectional view of an example of a mandibular condoyle 10 and temporal fossa 20 of an individual. Two relevant points that may be used for determining the condylar slope 15, according to an embodiment, as shown in the arbitrary X-Y plane of the cross-sectional view of FIG. 2A, are identified with the coordinates (X.sub.1, Y.sub.1) and (X.sub.2, Y.sub.2). For example, in some embodiments, the relevant points may be input or selected by a user, such as, for example, by a user viewing a digital representation of the individual's jaw anatomy displayed on a user interface (UI) and selecting the relevant points using a mouse, keyboard or other implement configured to interface with the user interface and provide point selection capability to the user. In other embodiments, the relevant points may be automatically determined or calculated. Machine learning algorithms may be implemented and trained to facilitate automatic selection or identification of the relevant points used to determine the condylar slope 15.

[0030] FIG. 2B illustrates a cross-sectional view of an example of a maxillary incisor 30 of an individual with surrounding gum tissue 34. The slope 35 of the incisal guidance (also herein “incisal slope 35”) may be calculated based on relevant points of the lingual surface 32 of maxillary incisor 30. Incisor 30 will typically be a central maxillary incisor, but may include a lateral maxillary incisor. Two points on the lingual surface 32 that may be used for determining the incisal slope 35, according to an embodiment, as shown in the arbitrary X-Y plane of the cross-sectional view of FIG. 2B, are identified with the coordinates (X.sub.1, Y.sub.1) and (X.sub.2, Y.sub.2). For example, in some embodiments, the relevant points may be input or selected by a user, such as, for example, by a user viewing a digital representation of the dentition displayed on a user interface (UI) and selecting the two points using a mouse, keyboard or other implement configured to interface with the user interface and provide point selection capability to the user. In other embodiments, the two relevant points may be automatically determined or calculated. Machine learning algorithms may be implemented and trained to facilitate automatic selection or identification of the relevant points used to determine the incisal slope 35.

[0031] Each of the slope 15 of the condyle and slope 35 of the incisal guidance can be determined using the equation m=(Y.sub.2−Y.sub.1)/(X.sub.2−X.sub.1), where m is the slope and X.sub.1, Y.sub.1, X.sub.2 and Y.sub.2 are the relevant positional coordinates of the condyle 10 or the incisal guidance. In other embodiments, multiple relevant points may be determined or identified and a best fit equation or algorithm may be used to determine a slope using more than two relevant points.

[0032] FIG. 3A illustrates a cross-sectional view of an example of a mandible 25 of an individual, including a representation of the condylar slope 15 of condyle 10 in relation to the incisal slope 35 of maxillary incisor 30. A mandibular incisor 40 is also shown. FIG. 3B illustrates a cross-sectional view of an example of a mandible 25 of a different individual, including a representation of the condylar slope 15 of condyle 10 in relation to the incisal slope 35 of maxillary incisor 30. In certain embodiments, the condylar slope and the incisal slope are treated as independent variables such that either slope, or both slopes, may be used to design an appliance. As can be seen in FIG. 3A and FIG. 3B, the relative slopes of the incisal guidance and the condyle differ between the different individuals, which may require that different biasing constraints be determined and implemented in the dental appliance(s) worn by each individual to correct the different bites of each individual. For example, the individual of FIG. 3B may require a different treatment plan, and possibly a longer-in-time treatment plan, based on needing a greater anterior displacement of the mandible when compared to the individual of FIG. 3A who appears to have a less-pronounced overjet.

[0033] Returning to FIG. 1, at step 3, at least one removable orthodontic appliance is fabricated, with the orthodontic appliance including one or more constraining features configured to constrain a posterior or anterior movement of the mandible relative to the maxilla when worn by the individual. For example, one or multiple orthodontic appliances may be fabricated according to a treatment plan designed to correct the bite. A single maxillary appliance may be fabricated or series of maxillary appliances, with incremental changes, may be fabricated. A position or location or configuration of the constraining feature(s) is determined based on the condylar slope 15 or the slope 35 of the incisal guidance or both the condylar slope 15 and the slope 35 of the incisal guidance. The constraining feature(s) are positioned to preferentially constrain an anterior movement or a posterior movement of the mandible with respect to the maxillae and thereby promote a desired anterior or posterior repositioning of the mandible over time with respect to the maxillae as determined by a dentist or other user, where any force on the mandible is created by the muscles of mastication due to the biasing of the constraining features. In another embodiment, an orthodontic appliance pair (e.g., a maxillary appliance and a complementary mandibular appliance) may be fabricated, or a series of appliance pairs, with incremental changes, may be fabricated.

[0034] FIG. 4 illustrates a cross-sectional view of a maxillary appliance 50 according to an embodiment, as worn by an individual. Maxillary appliance 50 includes a structure configured to mate with the geometry of the maxillary dentition and adjacent gum tissue of the individual. As shown, in an embodiment, maxillary appliance 50 includes a series of shelf or ridge features A, B and C proximal to the lingual surface of incisor 30. Each shelf or ridge feature may be designed, e.g., sized, to interact with and constrain mandibular incisor 40 when worn by the individual. The number and the size of the increments of the constraining features may be determined by a dentist or other user. For example, the maxillary appliance 50 may be designed with a single constraining feature, e.g., ridge A or B or C, or it may be designed with more than one constraining feature.

[0035] FIG. 5 illustrates a cross-sectional view of an appliance pair including removable maxillary appliance 50 and complementary removable mandibular appliance 55, according to an embodiment, as worn by an individual. Complementary removable mandibular appliance 55 includes a structure configured to mate with the geometry of the mandibular dentition and adjacent gum tissue of the individual and is configured to interact with the constraining feature(s) of the maxillary appliance 50 to constrain the posterior or anterior movement of the mandible relative to the maxillae. For example, in an embodiment, a constraining feature of the maxillary appliance 50 includes one or multiple barb or hook elements, and the complementary removable maxillary appliance 55 includes one or multiple complementary barb or hook elements configured to removably engage with the one or multiple barb or hook elements of maxillary appliance 50. The constraining feature may include a geometry configured to interact and positively engage the opposing surface with shapes such as but not limited to opposing barbs or “J” hooks, or combinations such as barbs and inverted “U” shaped hooks or features such as may be found in Velcro™ material. Such geometries may be preferentially placed or located on selected opposing surfaces along the arch so that these opposing surfaces preferentially engage where desired, such surfaces on the maxillary appliance as exemplified in “A, B, or C” in FIG. 4.

[0036] The barb or hook elements may be made of the same material as the appliances and should have sufficient resiliency to prevent separation once connected or engaged unless a threshold amount of lateral and/or posterior/anterior force is applied to the mandible by the wearing individual to separate or unhook the features to permit unhindered jaw movement.

[0037] In certain embodiments, a series or plurality of removable orthodontic appliances or orthodontic appliance pairs are fabricated. In certain embodiments, the position and/or orientation of the constraining feature(s) of each subsequent appliance or appliance pair may include an incremental positional and/or orientation change relative to the position and/or orientation of the constraining feature(s) of a prior appliance or appliance pair. A number of incremental positional changes and a size of each incremental positional change may be determined based on user input.

[0038] The complementary constraining features on maxillary appliance 50 and mandibular appliance 55 may be positioned and oriented so as to preferentially constrain an anterior movement or a posterior movement of the mandible with respect to the maxilla and thereby promote an anterior or posterior repositioning of the mandible over time with respect to the maxillae as determined by a dentist or other user. Any force on the mandible is created by the muscles of mastication due to the biasing of the constraining features rather than created directly by the appliances.

[0039] In certain embodiments, the occlusal area associated with the interacting geometries of the appliances and/or constraining feature(s) are customized for each individual, and the location in the arch (anterior, posterior) of the interacting geometries are customized for each individual. For example, an individual with an anterior open bite might have these interacting surfaces located in the posterior areas where there is occlusal contact. Alternatively an individual with posterior open bite, either naturally occurring or created with a bite plane or other appliance, might have these interacting surfaces in an anterior location.

[0040] In certain embodiments, each appliance (e.g., maxillary appliance 50 and mandibular appliance 55) may include a clear aligner fabricated using polymers or other clear material as is well known. In an embodiment, a dental appliance may be fabricated using a computer-assisted manufacturing process, such as 3-D printing based on a STL file generated by the processing system and provided to a 3-D printing system. In another embodiment, a dental appliance may be formed by a thermoforming process, e.g., a polymer-based material thermoformed over a mold of the dentition.

[0041] In certain embodiments, each constraining feature, e.g., shelf or ridge and/or hook or barb-type elements, may be formed integrally with the clear aligner. In other embodiments, such features may be formed separately from the appliance and attached or secured to the appliance. For example, in an embodiment, a constraining feature may be fabricated on a thin substrate which may be adhered or bonding to the appliance, e.g., clear aligner. The thin substrate may include the same material as the appliance or it may include a different material, such as a different polymer material.

[0042] As used herein, the terms “constrain” or “constraining” with regard to movement are not intended to exclude or tightly restrict movement, and generally permit or allow for at least some movement. For example, the constraining features provide for a planned repositioning of the mandible, yet the mandible remains free to open and close so it is not tightly constrained; the “constraining” features still permit or allow for movement of the mandible.

[0043] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0044] The use of the terms “a” and “an” and “the” and “at least one” and similar referents in the context of describing the disclosed subject matter (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The use of the term “at least one” followed by a list of one or more items (for example, “at least one of A and B”) is to be construed to mean one item selected from the listed items (A or B) or any combination of two or more of the listed items (A and B), unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or example language (e.g., “such as”) provided herein, is intended merely to better illuminate the disclosed subject matter and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0045] Certain embodiments are described herein. Variations of those embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventor intends for the embodiments to be practiced otherwise than as specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.