Dental braces and related manufacturing methods

Abstract

An orthodontic appliance and a method for manufacturing the same are disclosed. Manufacturing the appliance may include obtaining position data associated with an original tooth arrangement (OTA) of a patient's teeth, obtaining data corresponding to a desired final tooth arrangement (FTA) of the patient's teeth, and determining a displacement between the OTA data and the FTA data. Based on the determined displacement, a configuration of the orthodontic appliance is determined. The appliance includes an anchor configured to be positioned adjacent to a tooth, and a plurality of arms, each arm extending away from and coupled to the anchor, the arms being configured to be secured to the patient's teeth. When the appliance is installed, the arms push each tooth from the OTA toward the FTA.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 842,391, filed May 2, 2019, the disclosure of which is incorporated herein by reference in its entirety.

[0003] This application is also related to the following applications, each of which is incorporated herein by reference in its entirety: U.S. Provisional Patent Application No. 62 / 956,290, filed January 1, 2020; U.S. Patent Application No. 16 / 865,323, filed May 2, 2020, entitled DENTAL APPLIANCES, SYSTEMS, AND METHODS; and International Patent Application No. PCT / US20 / 31211, filed May 2, 2020, entitled DENTAL APPLIANCES, SYSTEMS, AND METHODS. Methods; U.S. patent application Ser. No. 15 / 929,443, filed May 2, 2020, entitled DENTAL APPLIANCES AND RELATED SYSTEMS AND METHODS OF USE; U.S. patent application Ser. No. 15 / 929,444, filed May 2, 2020, entitled DENTAL APPLIANCES AND RELATED SYSTEMS AND METHODS OF USE; and International Application No. PCT / US20 / 70017, filed May 2, 2020, entitled DENTAL APPLIANCES AND RELATED SYSTEMS AND METHODS OF USE. Technical Field

[0004] The present invention relates to the field of orthodontics, and more particularly, to devices, systems and methods for designing and manufacturing orthodontic appliances. Background Art

[0005] A common goal of orthodontics is to move a patient's teeth into a position that maximizes both function and aesthetics. To move teeth, an orthodontist first obtains multiple scans and / or impressions of the patient's teeth to determine a range of correction paths between the teeth's initial position and the desired final position. The orthodontist then fits the patient with one of two main types of braces: braces or aligners.

[0006] Traditional braces consist of brackets and an archwire that is arranged across the front of the teeth, with an elastic tie or ligature wire securing the archwire to the bracket. In some cases, self-ligating brackets can be used instead of the band or wire. The shape and stiffness of the archwire and the interaction between the archwire and the bracket determine the force applied to the teeth, thereby determining the direction and extent of tooth movement. In order to apply the required force on the teeth, the orthodontist often manually bends the archwire. The orthodontist monitors the patient's treatment progress through regular visits, during which the orthodontist visually assesses the treatment progress and manually adjusts the archwire (such as making a new bend) and / or replaces or repositions the brackets. The adjustment process is time-consuming and tedious for the patient and often causes discomfort to the patient within a few days of the visit. In addition, braces are aesthetically unattractive and make brushing, flossing and other dental hygiene procedures difficult.

[0007] Aligners consist of a clear, removable polymer shell with cavities for receiving and repositioning teeth to create the final dental arrangement. Known as "invisible braces," aligners provide patients with aesthetic results that are significantly superior to braces. Aligners do not require the orthodontist to bend wires or reposition brackets and are generally more comfortable than braces. However, unlike braces, aligners cannot effectively treat all malocclusions. Certain tooth repositioning steps (such as extrusion, translation, and certain rotations) may be difficult or impossible to achieve using aligners. Furthermore, because the aligners are removable, the success of the treatment depends largely on the patient's compliance, which can be unpredictable and inconsistent.

[0008] Lingual braces are an alternative to aligners and traditional (buccal) braces and have become increasingly popular in recent years. Two examples of lingual braces available are Incognito TM Orthotic System (3M USA) and (Swift Health Systems, Irvine, CA, USA), each consists of brackets and an archwire that is placed on the lingual, or tongue, side of the teeth. Compared to traditional braces, lingual braces are virtually invisible, and, unlike aligners, they are fixed to the patient's teeth and force patient compliance. However, these existing lingual technologies also have some disadvantages. Most notably, traditional lingual braces still rely on a bracket-archwire system to move the teeth, requiring multiple follow-up visits and painful adjustments. For example, lingual technology has a relatively short internal bracket spacing, which generally makes the archwire more flexible. As a result, the entire lingual aligner is more sensitive to archwire adjustments, causing more pain for the patient. In addition, the lingual side of the braces can irritate the tongue, affect speech, and make the braces difficult to clean.

[0009] Therefore, there is a need for improved orthodontic appliances. Summary of the Invention

[0010] According to the various aspects described below, including reference Figure 1A-18 , to illustrate the subject technology. For convenience, examples of various aspects of the subject technology are described as numbered items (1, 2, 3, etc.). These are provided as examples and do not limit the subject technology.

[0011] Article 1 A method of manufacturing an orthodontic appliance comprising:

[0012] Acquire data corresponding to the original tooth arrangement (OTA) of the patient's teeth,

[0013] acquiring data corresponding to a desired final tooth arrangement (FTA) of the patient's teeth;

[0014] Determine the displacement between OTA data and FTA data;

[0015] Based on the determined displacement, the configuration of the orthodontic appliance is determined, including:

[0016] an anchor configured to be positioned adjacent a patient's tooth; and

[0017] a plurality of arms, each arm extending away from and coupled to the anchor, the arms being configured to be secured to the patient's teeth,

[0018] Therein, when the aligners are installed, the arms push the patient's individual teeth from the OTA to the FTA.

[0019] Clause 2. A method according to any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising a displacement between the OTA data and the FTA data.

[0020] Article 3. A method according to any of the articles herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising a surface of the aperiodontal ligament or a root area of ​​one or more teeth.

[0021] Clause 4. A method according to any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising bone density of the patient.

[0022] Article 5. A method according to any of the articles herein, wherein determining the configuration of an orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising one or more biological determinants obtained from saliva, gingival crevicular fluid, blood, urine, or mucosa of the patient.

[0023] Clause 6. A method according to any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising the patient's gender.

[0024] Clause 7. The method of any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising the patient's ethnicity.

[0025] Clause 8. A method according to any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising the age of the patient.

[0026] Clause 9. A method according to any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising a jaw to which the appliance is to be mounted.

[0027] Clause 10. The method of any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising the number of teeth to which the appliance is to be mounted.

[0028] Article 11 A method according to any of the articles herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising mechanical properties of bone and tissue (lips, tongue and / or gums) proximate to the teeth to be moved.

[0029] Clause 12. A method according to any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a design of one or more arms.

[0030] Clause 13. A method according to any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a width of one or more of the plurality of arms.

[0031] Clause 14. The method of any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a thickness dimension of the appliance.

[0032] Clause 15. A method according to any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising mechanical properties of one or more arms of the plurality of arms.

[0033] Clause 16. The method of any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a design of the anchor.

[0034] Clause 17. The method of any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a width or thickness of the anchor.

[0035] Clause 18. A method according to any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a transition temperature of a material in one or more segments of the appliance.

[0036] Clause 19. The method of any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising connection locations between the plurality of arms and anchors.

[0037] Clause 20. A method according to any of the clauses herein, wherein acquiring OTA data comprises imaging the patient's teeth.

[0038] Clause 21. The method of any of the clauses herein, wherein acquiring OTA data comprises receiving image data of a patient's teeth.

[0039] Clause 22. A method according to any of the clauses herein, wherein obtaining the FTA data comprises receiving the FTA data from one or more remote computing devices.

[0040] Clause 23. The method of any of the clauses herein, wherein acquiring the FTA data comprises manipulating the tooth position from the OTA to a second arrangement and generating the FTA data based on the second arrangement.

[0041] Clause 24. The method of any of the clauses herein, wherein determining the displacement comprises determining the displacement along six degrees of freedom.

[0042] Clause 25. The method of any of the clauses herein, wherein determining the displacement comprises determining a longitudinal displacement along at least one of an occlusal-gingival axis, a buccal-lingual axis, or a mesio-distal axis.

[0043] Clause 26. The method of any of the clauses herein, wherein determining the displacement comprises determining a rotational displacement along at least one of an occlusal-gingival axis, a buccal-lingual axis, or a mesio-distal axis.

[0044] Clause 27. The method of any of the clauses herein, wherein determining the displacement comprises determining a translation of each of the patient's teeth.

[0045] Clause 28. The method of any of the clauses herein, wherein determining the displacement comprises determining a rotation of each of the teeth of the patient.

[0046] Item 29. The method of any of the items herein, further comprising determining, for each of the patient's teeth, a force required to achieve the determined displacement.

[0047] Item 30. The method of any of the items herein, further comprising determining, for each of each of the patient's teeth, a torque required to achieve the determined displacement.

[0048] Clause 31. A method according to any of the clauses herein, wherein each arm is configured to couple to a different one of the patient's teeth.

[0049] Article 32. A method according to any of the articles herein, wherein determining the configuration of the orthodontic appliance comprises selecting an arm configuration for each of each of the patient's teeth, the arm being configured to apply a required force and / or torque to achieve a determined displacement of the corresponding tooth.

[0050] Clause 33. A method according to any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises determining a configuration of an arm of a plurality of arms, the arm being configured to effect a determined displacement of a corresponding tooth.

[0051] Clause 34. The method of any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises selecting an arm design from a library of predetermined arm designs.

[0052] Clause 35. A method according to any of the clauses herein, wherein determining the configuration of the orthodontic appliance comprises designing a biasing portion of each arm to achieve a determined displacement of the corresponding tooth.

[0053] Item 36. The method of any of the items herein, further comprising determining a force and a moment for achieving the determined displacement of each tooth, and selecting an arm to achieve the determined force and moment.

[0054] Clause 37. The method according to any of the clauses herein, further comprising obtaining position data corresponding to positions of the patient's teeth in the OTA, indicating positions at which a plurality of securing members are configured to be attached to the patient's teeth.

[0055] Article 38 A method of manufacturing an orthodontic appliance, comprising:

[0056] Acquiring three-dimensional (3D) shape data of the orthosis;

[0057] generating planar shape data based on the 3D shape data;

[0058] forming a basic planar component based on the planar shape data;

[0059] Manipulating components into 3D configurations; and

[0060] Fix the shape of components in 3D configuration.

[0061] Clause 39. The method of any of the clauses herein, wherein the 3D shape data corresponds to a final tooth arrangement (FTA).

[0062] Clause 40. A method according to any of the clauses herein, wherein the 3D shape data corresponds at least in part to a surface of a heat treatment fixture.

[0063] Clause 41. The method of any of the clauses herein, wherein the 3D shape data defines an anchor and a plurality of arms extending away from the anchor, each arm configured to couple to at least one tooth of the patient.

[0064] Clause 42. A method according to any of the clauses herein, wherein the planar shape data comprises elongated shape data.

[0065] Clause 43. A method according to any of the clauses herein, wherein the planar shape data comprises 2D shape data.

[0066] Clause 44. A method according to any of the clauses herein, wherein generating the planar shape data comprises flattening the 3D shape data.

[0067] Clause 45. A method according to any of the clauses herein, wherein generating the planar shape data comprises converting the 3D shape data into the planar shape data.

[0068] Clause 46. A method according to any of the clauses herein, wherein forming the substantially planar member comprises cutting the substantially planar member from a sheet of material based at least in part on the planar shape data.

[0069] Clause 47. A method according to any of the clauses herein, wherein forming the substantially planar member comprises cutting the substantially planar member from a metal sheet.

[0070] Clause 48. A method according to any of the clauses herein, wherein forming the substantially planar member comprises cutting the substantially planar member from a Nitinol sheet.

[0071] Item 49. A method according to any of the items herein, wherein forming the substantially planar member comprises cutting the member from a sheet of material having a thickness between about 0.1 mm and about 1.0 mm, between about 0.2 mm and about 0.9 mm, between about 0.3 mm and about 0.8 mm, between about 0.4 mm and about 0.7 mm, or about 0.5 mm.

[0072] Article 50. A method according to any of the articles herein, wherein forming the substantially planar member comprises cutting the member from a sheet of material having a thickness of less than about 1.5 mm, less than about 1.4 mm, less than about 1.3 mm, less than about 1.2 mm, less than about 1.1 mm, less than about 1.0 mm, less than about 0.9 mm, less than about 0.8 mm, less than about 0.7 mm, less than about 0.6 mm, less than about 0.5 mm, less than about 0.4 mm, less than about 0.3 mm, less than about 0.2 mm, or less than about 0.1 mm.

[0073] Clause 51. A method according to any of the clauses herein, wherein forming the substantially planar member comprises cutting the substantially planar member from a sheet of material by at least one of laser cutting, milling, wire electrical discharge machining, water jetting, punching, or stamping.

[0074] Clause 52. A method according to any of the clauses herein, wherein the manipulation member comprises a bending member.

[0075] Clause 53. The method of any of the clauses herein, wherein manipulating the component comprises coupling the component to a heat treatment fixture.

[0076] Clause 54. A method according to any of the clauses herein, wherein manipulating the component comprises conforming the component to a surface of a heat treatment fixture.

[0077] Clause 55. The method of clause 53 or clause 54 herein, wherein the heat treatment fixture comprises a surface geometry corresponding to the 3D configuration.

[0078] Clause 56. The method according to clauses 53 to 55 herein, further comprising securing the component to a heat treatment fixture.

[0079] Clause 57. The method of Clause 56 herein, wherein fastening comprises securing the component to the heat treatment fixture via one or more elongated flexible elements.

[0080] Clause 58. A method according to any of the clauses herein, wherein shape-setting the component comprises heat-setting the component.

[0081] Clause 59. The method of any of the clauses herein, wherein the shaping of the component to fix the component shape comprises heating the component to at least 200 degrees Celsius.

[0082] Clause 60. The method according to Clause 58 or 59 herein, further comprising cooling the component by liquid quenching or air cooling after heating the component.

[0083] Clause 61. The method according to clauses 58 to 60 herein, further comprising removing the component from the heat treatment fixture.

[0084] Item 62. The method according to Item 61, further comprising polishing, electropolishing, electroplating, coating, ultrasonic cleaning, or sterilizing the component after removing the component from the heat treatment fixture.

[0085] Item 63. A method according to any of the items herein, further comprising selectively thinning at least a portion of the planar member.

[0086] Item 64. The method of Item 63 herein, wherein the selective thinning comprises one or more of: grinding, etching, or machining.

[0087] Item 65. A method according to any of the items herein, further comprising selectively thickening at least a portion of the planar member.

[0088] Clause 66. The method of clause 65 herein, wherein the selective thickening comprises 3D printing, electroplating, or thin film deposition on at least a portion of the planar member.

[0089] Article 67 A method of manufacturing a heat treatment fixture for an orthodontic appliance, the method comprising:

[0090] obtaining final tooth arrangement (FTA) data corresponding to a desired tooth arrangement;

[0091] manipulating the FTA data to obtain fixture data defining the geometry of the heat treating fixture; and

[0092] A heat treating fixture is manufactured based at least in part on the fixture data.

[0093] Clause 68. A method according to any of the clauses herein, wherein the FTA data includes a fixation member location at which a fixation member is configured to be placed on each tooth.

[0094] Clause 69. The method of clause 68, wherein the fixing member is configured to cooperate with an arm of the orthodontic appliance.

[0095] Clause 70. The method of any of the clauses herein, wherein the FTA data comprises data characterizing gingiva, wherein manipulating the modified FTA data comprises changing a size and / or position of the gingiva.

[0096] Clause 71. The method of clause 70, wherein altering the size and / or position of the gums comprises expanding the gums.

[0097] Clause 72. The method of clause 70 or clause 71, wherein altering the size of the gum comprises expanding the gum in at least a lingual direction.

[0098] Clause 73. The method of any one of Clauses 70 to 72, wherein changing the size or position of the gums comprises expanding the gums by a distance of less than about 1.5 mm, less than about 1.4 mm, less than about 1.3 mm, less than about 1.2 mm, less than about 1.1 mm, less than about 1.0 mm, less than about 0.9 mm, less than about 0.8 mm, less than about 0.7 mm, less than about 0.6 mm, less than about 0.5 mm, less than about 0.4 mm, less than about 0.3 mm, less than about 0.2 mm, or less than about 0.1 mm.

[0099] Clause 74. A method according to any of the clauses herein, wherein manipulating the FTA data comprises removing one or more teeth from the FTA data.

[0100] Clause 75. A method according to any of the clauses herein, wherein manipulating the FTA data comprises adding a strengthening element.

[0101] Clause 76. A method according to any of the clauses herein, wherein manipulating the FTA data comprises adding a crossbar.

[0102] Clause 77: The method of any of the clauses herein, wherein the FTA data is manipulated to change the geometry of the heat treatment fixture to increase its stiffness.

[0103] Clause 78. A method according to any of the clauses herein, wherein the FTA data comprises data characterizing a fixture member, and wherein manipulating the FTA data comprises modifying the fixture member data to change a shape of the fixture member.

[0104] Clause 79. The method of any of the clauses herein, wherein the FTA data comprises a fixation member configured to mate with an orthodontic appliance arm, wherein modifying the FTA data comprises changing a shape of the fixation member.

[0105] Clause 80. The method of clause 79, wherein changing the shape of the fixation member comprises shaping the fixation member to mate with an arm of the orthodontic appliance and to receive an elongated fastener for coupling the appliance to the heat treatment fixture.

[0106] Item 81. A method according to any of the items herein, wherein manufacturing the heat treatment fixture comprises forming the heat treatment fixture of a metal or ceramic material.

[0107] Clause 82. The method of any of the clauses herein, wherein manufacturing the heat treatment fixture comprises forming the heat treatment fixture using one or more of molding, 3D printing, or casting.

[0108] Item 83. The method according to any of the items herein, further comprising coupling the orthodontic appliance to a heat treatment fixture, and heating the appliance and the heat treatment fixture.

[0109] Clause 84. The method of clause 83, wherein heating the appliance and the heat treating fixture comprises heating to at least 200 degrees Celsius.

[0110] Article 85 The method according to Article 84 also includes cooling the straightener and heat treatment fixture by liquid quenching or air cooling after heating.

[0111] Clause 86. The method of any of Clauses 83 to 85, wherein coupling the orthodontic appliance to the heat treatment fixture comprises wrapping one or more elongated fasteners around the orthodontic appliance and the heat treatment fixture.

[0112] Article 87 A computer-readable medium, comprising a computer program product configured to store instructions that, when executed by one or more processors, cause the one or more processors to perform any of the methods described herein.

[0113] Article 88 - Installation, including:

[0114] one or more processors; and

[0115] A computer-readable medium, comprising a computer configured to store instructions, which, when executed by one or more processors, cause the one or more processors to perform any of the methods described herein.

[0116] Article 89. An orthodontic appliance manufactured according to any method described herein.

[0117] Article 90: A heat treatment fixture manufactured according to the method of any one of the articles herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0118] Many aspects of the present disclosure may be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed upon clearly illustrating the principles of the present disclosure.

[0119] Figure 1A A schematic diagram of an orthodontic appliance configured in accordance with the present technology is shown, mounted in the patient's mouth adjacent the patient's dentition.

[0120] Figure 1B is a schematic diagram of connection configuration options configured according to an embodiment of the present technology.

[0121] Figure 1C is a schematic diagram of a portion of an orthosis configured in accordance with an embodiment of the present technology.

[0122] Figure 2A and 2B is a front view of an orthodontic appliance configured according to several embodiments of the present technology, wherein the orthodontic appliance is installed in the upper and lower jaws of a patient's mouth, and the patient's teeth are in the original tooth arrangement and the final tooth arrangement, respectively.

[0123] Figure 2C is a graph showing stress-strain curves for Nitinol and steel.

[0124] Figure 3 Depicted are example methods of manufacturing orthodontic appliances according to the present technology.

[0125] Figure 4 is a schematic block diagram of a system for manufacturing orthodontic appliances according to the present technology.

[0126] Figure 5 is a flow chart of a process for designing orthodontic appliances according to the present technology.

[0127] Figure 6 Scanning a patient's teeth to obtain original tooth arrangement data is shown.

[0128] Figure 7 An example of a digital model of a patient's teeth and gums in the original dental arrangement is shown.

[0129] Figure 8 An example of a digital model of a patient's teeth and gums in the final dental arrangement is shown.

[0130] Figure 9An example of a digital model of a fixed component is shown.

[0131] Figure 10 An example of a digital model of a patient's teeth and gums in an original dental arrangement and a plurality of fixation components is shown.

[0132] Figure 11 An example of a digital model of a patient's teeth and gums and a plurality of fixation components in a final dental arrangement is shown.

[0133] Figure 12 An example of a digital model of a heat treatment fixture is shown.

[0134] Figure 13 An example of a digital model of a three-dimensional orthotic template based on a heat treatment fixture model is shown.

[0135] Figure 14 An example of a digital model of a substantially planar orthotic template is shown.

[0136] Figure 15 An example of a digital model of an appliance with a base plane having unique arm geometry based on determined displacements for each tooth is shown.

[0137] Figure 16 A perspective view of an orthodontic appliance according to an embodiment of the present technology is shown.

[0138] Figure 17 A perspective view of a heat treatment jig for an orthosis according to the present technology is shown.

[0139] Figure 18 is a perspective view of an orthodontic appliance secured to a heat treatment fixture according to the present technology. DETAILED DESCRIPTION

[0140] The present technology generally relates to orthodontic appliances and related systems configured to reposition one or more teeth of a patient. In certain embodiments, the present technology relates to devices, systems, and methods for attaching or securing orthodontic appliances to teeth, as well as related methods for designing and manufacturing such appliances. Figure 1A-18 Specific details of several embodiments of the technology are described.

[0141] I. Definition

[0142] The terms used herein to provide anatomical directions or orientations are intended to encompass different orientations of an appliance installed in a patient's mouth, regardless of whether the structure is shown installed in the mouth in the accompanying drawings. For example, "mesial" refers to a direction along the patient's dental arch toward the midline of the patient's face; "distal" refers to a direction along the patient's dental arch away from the midline of the patient's face; "occlusal" refers to a direction toward the chewing surfaces of the patient's teeth; "gingival" refers to a direction toward the patient's gums or gums; "facial" refers to a direction toward the patient's lips or cheeks (used interchangeably herein with "buccal" and "labial"); and "lingual" refers to a direction toward the patient's tongue.

[0143] As used herein, the terms "proximal" and "distal" refer to locations closer and farther from a given reference point, respectively. In many cases, the reference point is a connector, such as an anchor, and "proximal" and "distal" refer to locations closer and farther from the reference connector, respectively, along a line passing through the centroid of a cross-section of the portion of the orthosis that branches from the reference connector.

[0144] As used herein, the terms "generally," "substantially," "about," and similar terms are used as terms of approximation rather than terms of degree, and are intended to account for the inherent variations in measurements or calculations that those skilled in the art would recognize.

[0145] As used herein, the term "operator" means a clinician, practitioner, technician, or any person or machine that designs and / or manufactures an orthodontic appliance or portion thereof and / or assists in the design and / or manufacture of an appliance or portion thereof, and / or any person or machine associated with installing the appliance in a patient's mouth and / or performing any subsequent treatment of the patient associated with the appliance.

[0146] As used herein, the term "force" refers to the magnitude and / or direction of force, torque, or a combination thereof.

[0147] II. Review of Current Technology of Orthodontic Braces

[0148] Figure 1A is a schematic illustration of an orthodontic appliance 100 (or "appliance 100") configured in accordance with an embodiment of the present technology, shown positioned in the mouth of a patient, proximate the patient's teeth. Figure 1Bis an enlarged view of a portion of the aligner 100. The aligner 100 is configured to be installed in the patient's mouth to apply force on one or more teeth to reposition all or some of the teeth. In some cases, the aligner 100 may additionally or alternatively be configured to maintain the position of one or more teeth. Figure 1A and 1B As shown, the aligner 100 may include a deformable member including one or more attachment portions 140 (each attachment portion schematically represented by a box), each attachment portion configured to be secured directly or indirectly to a tooth surface via a securing member 160. The aligner 100 may also include one or more connectors 102 (also schematically shown), each connector extending directly between the attachment portions 140 ("first connector 104"), between the attachment portions 140 and one or more other connectors 102 ("second connector 106"), or between two or more other connectors 102 ("third connector 108"). Figure 1A Only two attachment portions 140 and two connectors 102 are labeled for ease of illustration. As described herein, the number, configuration, and location of the connectors 102 and attachment portions 140 can be selected to provide a desired force on one or more teeth when the aligner 100 is installed.

[0149] The attachment portion 140 can be configured to be removably coupled to a fixing member 160 that is bonded, adhered, or otherwise affixed to the surface of one of the teeth to be moved. In some embodiments, one or more attachment portions 140 can be directly bonded, adhered, or otherwise affixed to the corresponding teeth without a fixing member or other connection interface at the tooth. Different attachment portions 140 of a given appliance 100 can have the same or different shapes, the same or different sizes, and / or the same or different configurations. The attachment portion 140 can include any attachment portion, bracket connector, and / or male connector element disclosed in U.S. Patent Publication No. 2017 / 0156823A1, which is incorporated herein by reference in its entirety.

[0150] The appliance 100 can include any number of attachment portions 140 suitable for securely attaching the appliance 100 to one or more teeth of the patient to achieve the desired movement. In some examples, multiple attachment portions 140 can be attached to a single tooth. The appliance 100 can include an attachment portion for each tooth, fewer attachment portions than teeth, or more attachment portions 140 than teeth. In these and other embodiments, one or more attachment portions 140 of the appliance 100 can be configured to couple to one, two, three, four, five, or more connectors 102.

[0151] As previously described, the connector 102 can include one or more first connectors 104 extending directly between the attachment portions 140. When the appliance 100 is installed in the patient's mouth, the one or more first connectors 104 can extend along a generally mesiodistal dimension. In these and other embodiments, the appliance 100 can include one or more first connectors 104 that extend along a generally occlusal and / or buccolingual dimension when the appliance 100 is installed in the patient's mouth. In some embodiments, the appliance 100 does not include any first connectors 104.

[0152] Additionally or alternatively, the connector 102 may include one or more second connectors 106 that extend between the one or more attachment portions 140 and the one or more connectors 102. The one or more second connectors 106 may extend along a generally occlusal-gingival dimension when the appliance 100 is installed in the patient's mouth. In these and other embodiments, the appliance 100 may include one or more second connectors 106 that extend along a generally mesio-distal and / or buccolingual dimension when the appliance 100 is installed in the patient's mouth. In some embodiments, the appliance 100 does not include any second connectors 106. In such embodiments, the appliance 100 will only include the first connector 104 extending between the attachment portions 140. The second connector 106 and the attachment portion 140 to which it is attached may include an "arm" as used herein (such as Figure 1A and 1B 130 in the figure). In some embodiments, multiple second connectors 106 can extend from the same location along the brace 100 to the same attachment portion 140. In such a case, the multiple second connectors 106 and the attachment portion 140 together comprise an "arm" as used herein. Using two or more connectors to connect two points on the brace 100 enables the application of greater force (relative to using a single connector to connect the same points) without increasing the strain on the single connector. This configuration is particularly beneficial given the spatial constraints of fixed displacement therapy herein.

[0153] Additionally or alternatively, the connector 102 may include one or more third connectors 108 extending between two or more other connectors 102. When the appliance 100 is installed in the patient's mouth, the one or more third connectors 108 may extend along a generally mesiodistal dimension. In these and other embodiments, the appliance 100 may include one or more third connectors 108 extending along a generally occlusal-gingival and / or buccolingual dimension when the appliance 100 is installed in the patient's mouth. In some embodiments, the appliance 100 does not include any third connectors 108. One, some, or all of the third connectors 108 may be positioned gingivally relative to one, some, or all of the first connectors 104. In some embodiments, the appliance 100 includes a single third connector 108 extending along at least two adjacent teeth and providing a common connection for two or more second connectors 106. In several embodiments, the appliance 100 includes a plurality of discrete third connectors 108, each extending along at least two adjacent teeth.

[0154] like Figure 1A As shown, in some embodiments, the brace 100 can be configured so that when the brace 100 is installed in the patient's mouth, all or a portion of one, some or all of the connectors 102 are arranged near the patient's gums. For example, one or more third connectors 108 can be configured so that all or a portion of the one or more third connectors 108 are located below the patient's gum line and near the gums but spaced apart from the gums. In many cases, it may be beneficial to provide a small gap (e.g., 0.5 mm or less) between the third connector 108 and the patient's gums because contact between the third connector 108 (or any part of the brace 100) and the gums can cause irritation and patient discomfort. In some embodiments, when the brace 100 is arranged in the patient's mouth, all or a portion of the third connector 108 is configured to be in direct contact with the gums. Additionally or alternatively, all or a portion of one or more first connectors 104 and / or second connectors 106 can be configured to be arranged in a position close to the gums.

[0155] According to some embodiments, one or more connectors 102 may extend between an attachment portion 140 or a connector 102 and a joint comprising (a) two or more connectors 102, (b) two or more attachment portions 140, or (c) at least one attachment portion 140 and at least one connector 102. According to some embodiments, one or more connectors 102 may extend between a first joint comprising (a) two or more connectors 102, (b) two or more attachment portions 140, or (c) at least one connecting member and at least one connector 102, and a second joint comprising (a) two or more connectors 102, (b) two or more attachment portions 140, or (c) at least one attachment portion 140 and at least one connector 102. Figure 1B An example of a connector 102 extending between (a) a joint between the second connector 106 and the third connector 108 and (b) a joint between the second connector 106 and the attachment portion 140 is schematically depicted in FIG. 1 and is labeled 109 in the figure.

[0156] Each connector 102 can be designed to have a desired stiffness so that a single connector 102 or a combination of connectors 102 exerts a desired force on one or more teeth. In many cases, the force exerted by a given connector 102 can be governed by Hooke's Law, or F=k×x, where F is the restoring force exerted by the connector 102, k is the stiffness coefficient of the connector 102, and x is the displacement. In the most basic example, if there is no connector 102 between two points on the aligner 100, the stiffness coefficient along that path is zero, and no force is exerted. In this example, each connector 102 of the present technology can have a different non-zero stiffness coefficient. For example, one or more connectors 102 can be rigid (i.e., have an infinite stiffness coefficient), such that the connector 102 does not flex or bend between its two endpoints. In some embodiments, one or more connectors 102 can be "flexible" (i.e., have a non-zero and positive stiffness coefficient), such that the connector 102 can deform to exert (or absorb) force on the associated one or more teeth or other connectors 102.

[0157] In some embodiments, it may be beneficial to include one or more rigid connectors between two or more teeth. Rigid connectors 102 are sometimes referred to herein as "rigid bars" or "anchors." Each rigid connector 102 may have sufficient rigidity to maintain and preserve its shape and resist bending. The rigidity of the connector 102 can be achieved by selecting a particular shape, width, length, thickness, and / or material. For example, a connector 102 configured to be relatively rigid may be used when the teeth to be connected to the connector 102 or arm will not move (or will move a limited amount) and may be used for anchorage. For example, molar teeth may provide good anchoring because the roots of molars are larger than most teeth and therefore require greater force to move. Additionally, anchoring one or more portions of the appliance 100 to multiple teeth is more secure than anchoring to a single tooth. As another example, a rigid connection may be desired when moving a group of teeth relative to one or more other teeth. For example, consider a patient with five teeth separated by a gap from one tooth, and the treatment plan is to close the gap. The best treatment is often to move one tooth toward five teeth, rather than the other way around. In such cases, it may be beneficial to provide one or more rigid connectors between the five teeth. For all of the above reasons and many others, the appliance 100 may include one or more rigid first connectors 104, one or more rigid second connectors 106, and / or one or more rigid third connectors 108.

[0158] In these and other embodiments, the orthosis 100 can include one or more flexible first connectors 104, one or more flexible second connectors 106, and / or one or more flexible third connectors 108. Each flexible connector 102 can have a specific shape, width, thickness, length, material, and / or other parameters to provide a desired degree of flexibility. According to some embodiments of the present technology, the stiffness of a given connector 102 can be adjusted by incorporating one or more resilient, flexible biasing portions 150. Figure 1B As shown schematically, one, some, or all of the connectors 102 may include one or more biasing portions 150, such as springs, each configured to apply a customized force specific to the tooth to which it is attached.

[0159] like Figure 1C As shown in the schematic diagram of FIG, the biasing portion 150 may extend along all or a portion of the longitudinal axis L1 of the corresponding connector 102 ( Figure 1COnly the longitudinal axis L1 for the second connector 106 and the longitudinal axis L2 for the third connector 108 are labeled in FIG. The direction and magnitude of the forces and torques applied to the teeth by the biasing portion 150 depend at least in part on the shape, width, thickness, length, material, shape-fixing conditions, and other parameters of the biasing portion 150. Thus, one or more aspects of the biasing portion 150 (including the aforementioned parameters) can be varied so that when the aligner 100 is installed in the patient's mouth, the corresponding arm 130, connector 102, and / or biasing portion 150 produces the desired tooth movement. Each arm 130 and / or biasing portion 150 can be designed to move one or more teeth in one, two, or all three translational directions (i.e., mesio-distal, buccolingual, and occlusal-gingival) and / or in one, two, or all three rotational directions (i.e., buccolingual root torque, mesio-distal angulation, and mesial out-in rotation).

[0160] The biasing portion 150 of the present technology can have any length, width, shape and / or size sufficient to move the corresponding tooth to the desired position. In some embodiments, one, some or all of the connectors 102 can have one or more inflection points along the corresponding biasing portion 150. The connector 102 and / or the biasing portion 150 can have a serpentine configuration such that the connector 102 and / or the biasing portion 150 folds in on itself at least once or multiple times before extending toward the attachment portion 140. For example, in some embodiments, the second connector 106 folds in on itself twice along the biasing portion 150, thereby forming a first concave region and a second concave region facing generally different directions relative to each other. The open loop or overlapping portion of the connector 102 corresponding to the biasing portion 150 can be arranged to extend the total width W ( Figure 1C ) bisects the plane P( Figure 1C ), with the additional length of the arm 130 and / or connector 102 being received by the medial and / or distal space of the arm 130 and / or connector 102. This allows the arm 130 and / or connector 102 to have a longer length (compared to a linear arm) to accommodate greater tooth movement despite the limited space in the occlusal-gingival or vertical dimension between any associated third connector 108 and the location where the arm 130 is attached to the tooth.

[0161] It should be understood that the biasing portion 150 can have other shapes or configurations. For example, in some embodiments, the connector 102 and / or the biasing portion 150 can include one or more linear regions that zig-zag toward the attachment portion 140. One, some, or all of the connectors 102 and / or the biasing portion 150 can have only linear segments or regions, or can have a combination of curved and linear regions. In some embodiments, one, some, or all of the connectors 102 and / or the biasing portion 150 do not include any curved portions.

[0162] According to some examples, a single connector 102 may have multiple biasing portions 150 connected in series along the longitudinal axis of the corresponding connector 102. In some embodiments, multiple connectors 102 may extend along the same or different paths between two points. In these embodiments, different connectors 102 may have the same stiffness or different stiffness.

[0163] In those embodiments where the orthosis 100 has two or more connectors 102 with biasing portions 150, some, none, or all of the connectors 102 may have the same or different lengths, the same or different widths, the same or different thicknesses, the same or different shapes, and / or may be made of the same or different materials, among other characteristics. In some embodiments, fewer than all of the connectors 102 have biasing portions 150. For example, a connector 102 without a biasing portion 150 may include one or more rigid connections between a rigid third connector 108 and an attachment portion 140. In some embodiments, none of the connectors 102 of the orthosis 100 have a biasing portion 150.

[0164] According to some embodiments, for example, Figure 1AAs schematically depicted in FIG, the brace 100 may include a single, continuous, substantially rigid third connector (referred to as an "anchor 120") and a plurality of flexible arms 130 extending away from the anchor 120. When the brace 100 is installed in the patient's mouth, each arm 130 can be connected to a different tooth to be moved and exert a specific force on its corresponding tooth, thereby allowing the operator to move each tooth independently. This configuration provides a significant improvement over conventional braces, in which all teeth are connected by a single archwire, so that movement of one tooth may result in unintended movement of one or more nearby teeth. As discussed in more detail herein, the independent and customized tooth movement performed by the brace of the present technology allows the operator to more efficiently move teeth from an original tooth arrangement ("OTA") to a final tooth arrangement ("FTA"), thereby avoiding periodic adjustments, reducing the number of return visits, and reducing or eliminating patient discomfort, as well as reducing overall treatment time (i.e., the length of time the brace is installed in the patient's mouth) by at least 50% relative to the overall treatment time of conventional braces.

[0165] The anchor 120 may comprise any structure of any shape and size configured to fit comfortably within the patient's mouth and provide a common support for one or more arms 130. In many embodiments, for example, Figure 1B As shown, when the brace 100 is installed in the patient's mouth, the anchor 120 is arranged near the patient's gums. For example, the brace can be designed so that, when installed in the patient's mouth, all or a portion of the anchor 120 is located below the patient's gum line, near but separated from the gums. In many cases, it may be beneficial to provide a small gap (e.g., 0.5 mm or less) between the anchor 120 (or any portion of the brace 100) and the patient's gums because contact between the anchor 120 and the gums may cause irritation and patient discomfort. In some embodiments, when the brace 100 is arranged in the patient's mouth, all or a portion of the anchor 120 is configured to contact the gums.

[0166] The anchor 120 may be much more rigid than the arms 130, such that when a force is applied to its corresponding tooth, the equal and opposite forces experienced by each arm 130 are offset by the rigidity of the anchor 120 and the forces exerted by the other arms 130, and do not significantly affect the forces on the other teeth. Thus, the anchor 120 effectively isolates the forces experienced by each arm 130 from the other arms 130, thereby enabling independent tooth movement.

[0167] According to some embodiments, for example, Figure 1A and 1BAs schematically shown in FIG, anchor 120 comprises an elongated member having a longitudinal axis L2 (see FIG. Figure 1C ) and forming an arched shape that is configured to extend along the patient's chin when the brace 100 is installed. In these and other embodiments, the anchor 120 can be shaped and sized to span two or more of the patient's teeth when positioned in the patient's mouth. In some examples, the anchor 120 comprises a rigid linear rod, or can include a structure having both linear and curved segments. In these and other embodiments, the anchor 120 can extend laterally through all or a portion of the patient's mouth (e.g., through all or a portion of the upper jaw, through all or a portion of the lower jaw, etc.) and / or in a generally anterior-posterior direction. Furthermore, the brace 100 can include a single anchor or multiple anchors. For example, the brace 100 can include a plurality of discrete, spaced-apart anchors, each having two or more arms 130 extending therefrom. In these and other embodiments, the brace 100 can include one or more other connectors extending between adjacent arms 130.

[0168] Any and all features discussed above with respect to the anchor 120 may be applicable to any of the third connectors 108 disclosed herein.

[0169] like Figure 1B As shown, each arm 130 can extend between a proximal or first end portion 130a and a distal or second end portion 130b and can have a longitudinal axis L extending between the first end portion 130a and the second end portion 130b. The first end portion 130a of one, some, or all of the arms 130 can be disposed at the anchor 120. In some embodiments, one, some, or all of the arms 130 are integrally formed with the anchor 120 such that the first end portions 130a of the arms are continuous with the anchor 120. The arms 130 can extend from the anchor 120 at intervals along the longitudinal axis L2 of the anchor 120, as shown. Figure 1A In some embodiments, the arms 130 can be spaced apart from each other at uniform intervals along the longitudinal axis L2 of the anchor 120, or spaced apart from each other at uneven intervals.

[0170] One, some, or all of the arms 130 may include an attachment portion 140 at or near the second end portion 130b. In some embodiments, for example, Figures 1A-1CAs shown, one or more arms 130 cantilever from the anchor 120 such that the second end portion 130b of the cantilevered arm 130 has a free distal portion. In these and other embodiments, the distal end of the attachment portion 140 can coincide with the distal end of the arm 130. The attachment portion 140 can be configured to removably couple the respective arm 130 to a fixed member (e.g., a bracket) that is bonded, adhered, or otherwise secured to the surface of a tooth to be moved. In some embodiments, the attachment portion 140 can be directly bonded, adhered, or otherwise secured to the respective tooth without a fixed member or other connection interface at the tooth.

[0171] Still refer to Figure 1A and 1B , one, some, or all of the arms 130 may include one or more resiliently flexible biasing portions 150, such as springs, each configured to apply a customized force, torque, or combination of force and torque specific to the tooth to which it is attached. The biasing portion 150 may extend between the anchor 120 and the attachment portion 140 along all or a portion of the longitudinal axis L1 of the corresponding arm 130. The direction and magnitude of the force and torque applied to the tooth by the biasing portion 150 depends at least in part on the shape, width, thickness, length, material, shape-fixing conditions, and other parameters of the biasing portion 150. Thus, one or more aspects of the arm 130 and / or the biasing portion 150 (including the aforementioned parameters) can be varied so that the arm 130 and / or the biasing portion 150 produces the desired tooth movement when the aligner 100 is installed in the patient's mouth. Each arm 130 and / or biasing portion 150 can be designed to move one or more teeth in one, two, or all three translational directions (i.e., mesio-distal, buccolingual, and occlusal-gingival) and / or in one, two, or all three rotational directions (i.e., buccolingual root torque, mesio-distal angulation, and mesio-external rotation).

[0172] The biasing portion 150 of the present technology can have any length, width, shape and / or size sufficient to move the corresponding tooth toward the desired FTA. In some embodiments, one, some, or all of the arms 130 can have one or more inflection points along the corresponding biasing portion 150. The arms 130 and / or biasing portion 150 can have a serpentine configuration such that the arms 130 and / or biasing portion 150 fold in on themselves at least once or multiple times before extending toward the attachment portion 140. Figure 1B150, thereby forming a first concave region and a second concave region that face generally different directions relative to each other. The open loop or overlapping portion of the arm 130 corresponding to the biasing portion 150 can be arranged on either side of a plane P that bisects the overall width W of the arm 130, so that the additional length of the arm 130 is accommodated by space in the center and / or distal side of the arm 130. This allows the arm 130 to have a longer length (compared to a linear arm) to accommodate greater tooth movement despite limited space in the occlusal-gingival or vertical dimension between the anchor 120 and the location where the arm 130 is attached to the tooth.

[0173] It should be understood that the biasing portion 150 can have other shapes or configurations. For example, in some embodiments, the arms 130 and / or the biasing portion 150 can include one or more linear regions that meander toward the attachment portion 140. One, some, or all of the arms 130 and / or the biasing portion 150 can have only linear segments or regions, or can have a combination of curved and linear regions. In some embodiments, one, some, or all of the arms 130 and / or the biasing portion 150 do not include any curved portions.

[0174] According to some examples, a single arm 130 may have multiple biasing portions 150. The multiple biasing portions 150 may be connected in series along the longitudinal axis L1 of the corresponding arm 130. In some embodiments, the multiple arms 130 may extend in parallel between two points along the same path or different paths. In these embodiments, different arms 130 may have the same stiffness or different stiffness.

[0175] In embodiments where the brace 100 has two or more arms 130 with biasing portions 150, some, none, or all of the arms 130 may have the same or different lengths, the same or different widths, the same or different thicknesses, the same or different shapes, and / or may be made of the same or different materials, among other characteristics. In some embodiments, fewer than all of the arms 130 have biasing portions 150. For example, an arm 130 without a biasing portion 150 may include one or more rigid connections between the anchor 120 and the attachment portion 140. In some embodiments, none of the arms 130 of the brace 100 have a biasing portion 150.

[0176] The braces of the present technology can include any number of arms 130 suitable for repositioning the patient's teeth while taking into account the patient's comfort. Unless expressly limited to a specific number of arms in the description, the braces of the present technology can include a single arm, two arms, three arms, five arms, ten arms, sixteen arms, etc. In some examples, one, some, or all of the arms 130 of the braces can be configured to be individually connected to more than one tooth (i.e., a single arm 130 can be configured to be connected to two teeth at the same time). In these and other embodiments, the braces 100 can include two or more arms 130 configured to be connected to the same tooth at the same time.

[0177] Any portion of an orthosis of the present technology may include a biasing portion 150. For example, in some embodiments, portions thereof (e.g., anchors, arms, biasing portions, attachment portions, links, etc.) may include one or more superelastic materials.

[0178] Additional details regarding the single directional force applied by the biasing portion 150 (or more generally, by the arm 130) are described in U.S. Patent Publication No. 2017 / 0156823A1, the disclosure of which is incorporated herein by reference in its entirety.

[0179] The orthosis disclosed herein and / or any portion thereof (e.g., anchors, arms, biasing portions, attachment portions, rods, etc.) may comprise one or more superelastic materials. The orthosis disclosed herein and / or any portion thereof (e.g., anchors, arms, biasing portions, attachment portions, rods, etc.) may comprise nitinol, stainless steel, beta titanium, cobalt chromium, MP35N, 35N LT, one or more metal alloys, one or more polymers, one or more ceramics, and / or combinations thereof.

[0180] Figure 2A and 2B is a front view of the appliance 100 mounted on both the upper and lower dental arches of a patient's mouth M, with the arms 130 coupled to the fixing members 160, which are attached to the lingual surfaces of the teeth. It should be understood that the appliance 100 of one or both of the upper and lower dental arches can be located near the buccal sides of the patient's teeth, and that the fixing members 160 and / or arms 130 can alternatively be coupled to the buccal surfaces of the teeth.

[0181] Figure 2A The tooth is shown in OTA, where the arm 130 is in a deformed or loaded state, Figure 2BA tooth is shown in a FTA position, with the arm 130 in a substantially unloaded state. When the tooth is in an OTA position, the arm 130 is forced to adopt a shape or path that is different from its "designed" configuration when the arm 130 is initially secured to the fixed member 160. Due to the inherent memory of the resilient biasing portion 150, the arm 130 exerts a continuous corrective force on the tooth to move the tooth toward the FTA position, which is the position when the biasing portion 150 is in its designed, or unloaded, configuration. Thus, braces using the present technology can accomplish tooth repositioning in a single step using a single brace. In addition to requiring fewer follow-up visits and shorter treatment times than braces, braces using the present technology also significantly reduce or eliminate the pain patients experience from tooth movement. With traditional braces, each time the orthodontist makes an adjustment (such as installing a new archwire, bending an existing archwire, repositioning brackets, etc.), the affected tooth is subjected to significant forces, which can be very painful for the patient. Over time, the applied forces gradually decrease until a new archwire is eventually required. However, the braces of the present technology continuously apply the force that produces movement to the teeth while the braces are installed, which allows the teeth to move at a slower rate, which is much less painful (if painful) for the patient. Even though the braces disclosed herein apply lower and less painful forces to the teeth, because the applied force is continuous and the teeth can move independently (and therefore more effectively), the braces of the present technology also reach FTA faster than traditional braces or aligners, both of which require intermediate adjustments.

[0182] In many embodiments, the motion-generating force is lower than that applied by conventional braces. In those embodiments where the aligner comprises a superelastic material, such as Nitinol, the superelastic material behaves like a constant-force spring over a range of strains, so the applied force does not drop significantly as the teeth move. For example, Figure 2C As shown in the stress-strain curves for Nitinol and steel, the curve for Nitinol is relatively flat compared to that for steel. Thus, the superelastic connectors, biasing portions, and / or arms of the present technology apply substantially the same stress for many different strain levels (e.g., deflections). Thus, as the teeth move during treatment, the force applied to a given tooth remains constant, at least until the teeth are very close to or in their final arrangement. The braces of the present technology are configured to apply a force that is just below the pain threshold so that the braces always apply the maximum non-painful force to the tooth (or teeth) during tooth movement. This results in the most efficient (i.e., fastest) tooth movement without pain.

[0183] In some embodiments, tooth repositioning may involve multiple steps performed incrementally using multiple appliances. Embodiments involving multiple steps (or multiple appliances, or both) may include one or more intermediate tooth arrangements (ITAs) between the original tooth arrangement (OTA) and the desired final tooth arrangement (FTA). Likewise, the appliances disclosed herein may be designed to be installed after a first or subsequently used appliance has moved teeth from an OTA to an ITA (or from one ITA to another) and subsequently removed. Thus, the appliances of the present technology may be designed to move teeth from an ITA to an FTA (or to another ITA). Additionally or alternatively, the appliances may be designed to move teeth from an OTA to an ITA, or from an OTA to an FTA, without changing the appliance at the ITA.

[0184] In some embodiments, the braces disclosed herein can be configured so that once the braces are mounted on the patient's teeth, the patient cannot remove the braces. In some embodiments, the braces are removable by the patient.

[0185] Any of the example braces or brace portions described herein may be made of any suitable material, such as, but not limited to, nickel-titanium alloy, stainless steel, beta titanium, cobalt-chromium alloy, or other metal alloys, polymers, or ceramics, and may be made into a single, integrally formed structure, or, alternatively, into a plurality of separately formed components that are connected together into a single structure. However, in specific examples, the rigid rods, bracket connectors, and annular or curved features of the braces (or portions of braces) described in these examples are made by cutting the two-dimensional (2D) shape of the brace from a 2D sheet of material and bending the 2D shape into the desired three-dimensional shape of the brace, according to a process described in more detail below. Alternatively or alternatively, the brace (or portion of a brace) may be formed using any suitable technique, including those described in U.S. Patent Publication No. 2017 / 0156823A1, which is incorporated herein by reference in its entirety.

[0186] III. Selection methods for manufacturing orthodontic appliances and fixtures

[0187] Figure 3An example process 300 for designing and manufacturing an orthodontic appliance described elsewhere herein is described. The specific processes described herein are exemplary processes only and may be modified as needed to achieve desired results (e.g., desired forces applied by the appliance to each tooth, desired material properties for the appliance, etc.). In various embodiments, other suitable methods or techniques may be used to manufacture the orthodontic appliance. Furthermore, although various aspects of the methods disclosed herein relate to an order of steps, in various embodiments, the steps may be performed in a different order, two or more steps may be combined, certain steps may be omitted, and additional steps not explicitly discussed may be included in the process as needed.

[0188] As described above, in some embodiments, an orthodontic appliance is configured to be coupled to the patient's teeth when the teeth are in an original tooth alignment (OTA). In this position, the elements of the appliance apply customized loads to the individual teeth, pushing them toward the desired final tooth alignment (FTA). For example, the arms 130 of the appliance 100 can be coupled to the teeth and configured to apply a force to push the teeth in a desired direction toward the FTA. In one example, the arms 130 of the appliance 100 can be configured to apply a pulling force that pushes the teeth lingually along the facial-lingual axis. By selecting the appropriate size, shape, set of shapes, material properties, and other aspects of the arms 130, a customized load can be applied to each tooth to move each tooth from its OTA toward its FTA. In some embodiments, each arm 130 is configured so that once the tooth to which the arm 130 is coupled reaches its FTA, little or no force is applied to the tooth. In other words, the appliance 100 can be configured so that the arms 130 are stationary in the FTA state.

[0189] like Figure 3 As shown, process 300 may begin by acquiring data (e.g., position data) representing an original dental arrangement (OTA) of a patient at block 302. In some embodiments, an operator may obtain a digital representation of the patient's OTA using, for example, optical scanning, cone beam computed tomography (CBCT), a patient impression scan, or other suitable imaging techniques to obtain position data of the patient's teeth, gums, and optionally other adjacent anatomical structures when the patient's teeth are in an original or pre-treatment state.

[0190] The process 300 continues at block 304 by obtaining data (e.g., position data) characterizing the patient's intended or desired final tooth arrangement (FTA). The data characterizing the FTA may include coordinates (e.g., X, Y, Z coordinates) of each of the patient's teeth and gums. Additionally or alternatively, such data may include the positioning of each of the patient's teeth relative to the patient's other teeth and / or gums. In some embodiments, an operator may obtain a digital representation of the patient's FTA, for example, using a digital model of the FTA generated using segmentation software (e.g., iROK digital Dentistry Studio) to create individual virtual teeth and gums from the OTA data. In some embodiments, a digital model of the fixation member 160 may be added to the segmented OTA digital model (e.g., by the operator selecting a location on the lingual surface (or other suitable surface) to place the fixation member 160 thereon). The virtual teeth to which the fixation member 160 is attached may be moved from the OTA to the desired final position (e.g., the FTA) using appropriate software, with or without the digital model of the fixation member.

[0191] At block 306, a digital model of the heat treatment fixture may be obtained. In some embodiments, the digital model of the heat treatment fixture may correspond to and / or be derived from the FTA digital model. For example, the FTA digital model may be modified in various ways (e.g., using MeshMixer or other suitable modeling software) to present a model suitable for manufacturing the heat treatment fixture. In some embodiments, the FTA digital model may be modified to include the fixation member 160 (which is configured to be connected to the arm 130 ( Figure 2A and 2B )) is replaced with a hook-shaped member (which can be configured to facilitate temporary connection of the heat treatment fixture to the aligner for shape fixation). Additionally or alternatively, the FTA digital model can be modified to enlarge or thicken the gums, move one or more teeth, and / or add structural components to increase stiffness. In some embodiments, the gums can be enlarged or thickened to ensure that portions of the aligner manufactured in part based on the FTA digital model (e.g., anchors) do not engage or contact the patient's gums when the aligner is installed. Therefore, the FTA digital model can be modified as described herein to provide a less painful tooth repositioning experience for the patient.

[0192] The process 300 continues at block 308 by obtaining a digital model of the orthosis. As used herein, the terms "digital model" and "model" mean a virtual representation of an object or a collection of objects. For example, the term "digital model of the orthosis" refers to a virtual representation of the structure and geometry of the orthosis, including its various components (e.g., anchors, arms, biasing portions, attachment portions, etc.). In some embodiments, a substantially planar digital model of the orthosis is generated based at least in part on a digital model of the heat treatment fixture (and / or a digital model of the FTA). According to some examples, a contour or 3D digital model of the orthosis that roughly corresponds to the surface and attachment features of the digital model of the heat treatment fixture can first be generated. In some embodiments, the 3D digital model of the orthosis can include generic arm portions and fixation members without requiring a specific geometry, size, or other characteristics of the arm selected or defined by a particular patient. The 3D digital model of the orthosis can then be flattened to generate a substantially planar or substantially 2D digital model of the orthosis. In some embodiments, the particular configuration of the arm 130 can then be selected (e.g., the geometry of the biasing portion 150, the location along the anchor 120, Figure 1B ), etc.) in order to apply the required force to urge the corresponding tooth (the tooth to which the arm 130 is connected) from its OTA toward its FTA. As previously mentioned, in some embodiments, the arm is configured to be substantially at rest or substantially stress-free when in the FTA. The selected arm configuration can then be replaced or incorporated into the flat digital model of the aligner.

[0193] At block 310, a heat treatment fixture may be fabricated. For example, using the heat treatment fixture digital model (block 306), the heat treatment fixture may be cast, molded, 3D printed, or otherwise fabricated using a suitable material configured to withstand heat for form-fixing on the aligner.

[0194] At block 312, the brace can be manufactured. In some embodiments, manufacturing the brace includes first manufacturing the brace in a planar configuration based on a planar digital model of the brace. For example, the planar brace can be cut from a sheet of metal or other suitable material. In some embodiments, the brace is cut from a sheet of nitinol or other metal using laser cutting, water jet, stamping, chemical etching, machining, or other suitable techniques. The material thickness of the brace can be varied, for example, by electropolishing, etching, grinding, deposition, or otherwise manipulating the material of the brace to achieve desired material properties.

[0195] According to some examples, a planar member (e.g., cut from a sheet of metal) can be bent or otherwise manipulated into a desired arrangement (e.g., substantially corresponding to the FTA) to form a contoured brace. In some embodiments, in block 310, the planar brace can be bent into place by coupling the planar brace to a heat treatment fixture. For example, the arms of the brace can be removably connected to hook members of the heat treatment fixture, and optionally, ligatures or other temporary fasteners can be used to secure the arms or other portions of the brace to the heat treatment fixture. The resulting assembly (i.e., the brace secured to the heat treatment fixture) can then be heated to secure the brace shape to a final shape, which can correspond or substantially correspond to the FTA. Thus, the brace is configured to be in a stress-free or nearly stress-free state when in the FTA. In operation, the brace can then be installed in the patient's mouth (e.g., by bending or otherwise manipulating the arms of the brace while in the OTA to connect them to the brackets on the patient's teeth). Due to the fixed shape of the appliance and the geometry of the arms and anchors, the arms urge each tooth away from its OTA and toward its FTA.

[0196] Additional details and further process examples for designing and manufacturing the aligners and heat treating fixtures are described below. The specific processes disclosed herein are exemplary and can be modified as needed to achieve the desired results (e.g., the desired force applied by the aligner to each tooth, the desired material properties of the final aligner, etc.). Furthermore, while various aspects of the methods disclosed herein involve a sequence of steps, in various embodiments, the steps can be performed in a different order, two or more steps can be combined, certain steps can be omitted, and additional steps not explicitly discussed can be included in the process as needed.

[0197] Several methods disclosed herein can be used Figure 4 4. The system 400 may include an imaging device 402 communicatively coupled to a computing device 404. The imaging device 402 may include any suitable device or collection of devices configured to obtain image data or other digital representations of a patient's teeth, gums, and other dental anatomical structures. For example, the imaging device 402 may include an optical scanning device (e.g., as commercially sold by ITERO, 3SHAPE, and others), a cone-beam computed tomography scanner, or any other suitable imaging device. In some embodiments, the imaging device 402 may be any suitable device for obtaining a digital representation (e.g., OTA) of a patient's anatomical structure, even if such a digital representation is not based on and does not produce a graphical representation of the patient's anatomical structure.

[0198] The computing device 404 can be any suitable combination of software and hardware. For example, the computing device 404 can include a special-purpose computer or data processor that is specially programmed, configured, or constructed to execute one or more computer-executable instructions explained in detail herein. Additionally or alternatively, the computing device 404 can include a distributed computing environment in which tasks or modules are performed by remote processing devices that are linked via a communication network (e.g., a wireless communication network, a wired communication network, a cellular communication network, the Internet, a short-range radio network (e.g., via Bluetooth)). In a distributed computing environment, program modules can be located in local and remote storage devices.

[0199] Computer-implemented instructions, data structures, and other data of various aspects of the present technology may be stored or distributed on computer-readable storage media, including magnetically or optically readable computer disks, as microcode on semiconductor memories, nanotechnology memories, organic or optical memories, or other portable and / or non-transitory data storage media. In some embodiments, various aspects of the technology may be distributed over a period of time on a propagation signal on a propagation medium (e.g., electromagnetic waves, acoustic waves) over the Internet or other networks (e.g., Bluetooth networks), or may be provided over any analog or digital network (packet switching, circuit switching, or other schemes).

[0200] The system 400 may also include one or more input devices 406 (e.g., a touch screen, keyboard, mouse, microphone, camera, etc.) and one or more output devices 408 (e.g., a display, speakers, etc.) coupled to the computing device 404. In operation, a user may provide instructions to the computing device 404 and receive output from the computing device 404 via the input devices 406 and the output devices 408.

[0201] like Figure 4 As shown, computing device 404 can be connected to one or more manufacturing systems 410 (including manufacturing machines) used to manufacture aligners, heat treatment fixtures, and any other components and related tools as described herein. Computing device 404 can be connected to manufacturing system 410 via any suitable communication connection, including but not limited to a direct electronic connection, a network connection, etc. Alternatively, the connection can be provided by delivering a physical, non-transitory storage medium to manufacturing system 410 on which data from computing device 404 is stored.

[0202] Design methods for orthodontic appliances and fixtures

[0203] Figure 5 5 is a flow chart of a process 500 for designing an orthodontic appliance. The process 500 begins at block 502 by obtaining data representing an original tooth arrangement (OTA). Figure 6As shown, OTA data can be obtained by scanning the patient's teeth using an intraoral optical scanner 600. Such a scanner 600 can be used to scan the patient's upper and lower teeth to generate a three-dimensional model of each. The scan can be performed using any suitable technology, such as a dental cone beam CT scanner, or magnetic resonance imaging (MRI) or similar equipment or technology. In various examples, OTA data may include data associated with the tooth roots and exposed portions, which may be advantageous in designing appropriate orthodontic appliances. In some examples, OTA data can be obtained using impressions made of the patient's upper and lower jaws (e.g., using polyvinyl siloxane or any other suitable impression material). The impression can then be scanned to create 3D data, which may include the relationship between the upper and lower jaws (e.g., recording the patient's bite). In an example using an impression, the relationship between the teeth in the upper and lower dental arches (inter-arch relationship) can be obtained by taking a wax bite of the patient's centric position. In various embodiments, OTA data may be obtained directly (eg, by imaging the patient's oral cavity using an appropriate imaging device) or indirectly (eg, by receiving pre-existing OTA data from an operator or another source).

[0204] Back to Figure 5 , the process 500 continues at block 504 by obtaining an OTA digital model. Figure 7 is a graphical representation of an example of an OTA digital model 700. The digital model 700 may virtually represent or characterize the arrangement of the patient's teeth and gums in the original dental arrangement. Figure 7 As shown, the teeth in the OTA may be maloccluded, misaligned, crowded, or require orthodontic correction. In some embodiments, one or more teeth present in the OTA may be specified to be extracted before using orthodontic braces.

[0205] In some embodiments, obtaining an OTA digital model corresponding to the OTA data can include first obtaining a single complex 3D database of the patient's jaw and then segmenting it to segment the patient's teeth into separate 3D entities (e.g., individual teeth or sets of teeth) that an operator can then virtually manipulate. This segmentation can be performed using any suitable technique or software, such as using iROK Digital Dentistry Studio or other suitable software. After segmentation, the generated three-dimensional database of the upper and lower teeth can include a gum model and an independent model of each tooth. Thus, the operator can manipulate the OTA data to virtually move the teeth relative to the gums. As described in more detail elsewhere herein, the teeth can be manipulated from the OTA to the final tooth arrangement (FTA). Figure 8 An example of a final tooth arrangement (FTA) is shown. Figure 8As shown, the teeth in the FTA can be better aligned, less maloccluded, and aesthetically and functionally improved relative to the OTA (e.g., as reflected in the digital model 700). In some embodiments, the FTA can have a desired or favorable inter-arch and intra-arch alignment, for example, based on the operator's prescription. For example, one or more (or all) teeth in the upper or lower jaw (or both) are moved until their tips have a good intersection and fit.

[0206] Return Reference Figure 5 , process 500 continues in block 506 to obtain a digital model of the fixed component. As previously described, fixed components (e.g., fixed component 160, brackets, etc.) can be coupled to the patient's teeth to allow an orthodontic appliance (e.g., appliance 10) to be matched thereto. The digital model of the fixed component may include a virtual representation of the geometry and / or other structural features of the fixed component. In various embodiments, the digital model of the fixed component may be the same for each fixed component, or may differ between fixed components. For example, different fixed components may be used for molars and incisors. Figure 9 An exemplary digital model of a fixation member 900 is shown.

[0207] Continue to refer Figure 5 , the process 500 continues in block 508 by obtaining an OTA digital model with a fixed component attached. For example, the fixed component 900 ( Figure 9 ) can be applied to OTA digital model 700( Figure 7 ) in the appropriate position on the patient's teeth. The resulting digital model 1000 is as follows Figure 10 As shown, multiple digital models of the fixation members 900 are arranged along the lingual side of the patient's teeth. In some embodiments, each of the patient's teeth in the digital model 1000 can have a fixation member coupled thereto. As previously described, an orthodontic appliance can include multiple arms having attachment portions configured to couple to fixation members (e.g., brackets) attached to the patient's teeth.

[0208] In some examples, a digital model of the fixation member 900 can be virtually positioned on the teeth in the OTA using appropriate software (e.g., iROK digital Dentistry Studio). In some embodiments, virtually positioning the fixation member can include selecting a virtual model of a particular fixation member from a library of available fixation members and then positioning the selected fixation member on one or more teeth. In some embodiments, bracket positioning can be specified automatically (e.g., by automatically positioning the bracket at the center or predefined portion of the tooth) or manually (e.g., by an operator selecting and / or manipulating the attachment location for each fixation member). In some embodiments, the operator can refine the position of each fixation member as needed. For example, it may be desirable to position the fixation member as close to the gums as possible to avoid interfering with a fixation member on the other jaw or interfering with teeth on the other jaw when the mouth is closed.

[0209] In some embodiments, a digital model 1000 having teeth in an OTA and fixed members attached thereto can be used to determine the configuration of a bonding tray, which can then be used by an operator to physically attach the fixed members to the patient's teeth. For example, the bonding tray can be configured to be mounted on the patient's teeth similar to an aligner, and can include grooves on each tooth side that are sized and configured to receive appropriate fixed members (e.g., brackets) therein. In various embodiments, such grooves can be positioned on the lingual, buccal, mesial / distal, occlusal, or any appropriate surface of the tooth to which the corresponding bracket is intended to be bonded. In operation, an appropriate fixed member can be placed in each groove, and then an adhesive (e.g., an adhesive that cures when exposed to ultraviolet light) is applied to the bonding surface of each fixed member. The tray can then be placed on the patient's teeth, and the adhesive cures to bond all the fixed members to the appropriate positions on each tooth.

[0210] To generate such a bonding tray, a digital model 1000 representing the teeth with the fixation components in OTA can be used. For example, the digital model 1000 can be further manipulated to remove excess virtual gingiva, thereby limiting the tray size to only that required to secure the fixation components in position against the patient's teeth. The trimmed digital model can then be used to generate a physical 3D model of the patient's teeth with the fixation components positioned thereon, for example using polymer resin 3D printing or other suitable techniques.

[0211] In some embodiments, a suitable material (e.g., a transparent polymer resin) can then be formed (e.g., thermoformed) over a physical model of the patient's teeth with the fixation members in the OTA. This can create a tray similar to an aligner, having recesses shaped and configured to receive the fixation members therein. The fixation members can then be placed in corresponding recesses of the tray, and the tray can be applied to the patient's teeth using a curable adhesive to attach the fixation members to the patient's teeth in the OTA. The tray can then be removed, leaving the fixation members in place.

[0212] In some embodiments, the bonding tray can be 3D printed directly without the need for a physical model of the patient's teeth and without the use of thermoforming. For example, a digital model of the bonding tray can be derived from the digital model 1000, which represents the teeth with fixed components attached in the OTA. In some embodiments, a negative of the digital model 1000 can be generated, and the negative can be trimmed to provide a general tray-like structure with surfaces corresponding to the teeth and fixed components in the digital model 1000. The generated model can be manipulated to provide features for securing the brackets in the corresponding grooves. Finally, the bonding tray can be 3D printed based on the digital model, for example using a 3D printable polymer resin or other suitable material or deposition technology.

[0213] Alternatively, the operator may attach the fixation members directly to the patient's teeth without the aid of a tray.

[0214] Reference again Figure 5 The process 500 continues at block 510 by obtaining a FTA digital model 1100 ( Figure 11 For example, a digital model 1000 of a tooth with a model of a fixing member 900 in OTA ( Figure 10 ) can be used to generate the FTA digital model 1100 ( Figure 11 ). In some embodiments, the digital model 1000 can be manipulated to place the teeth in the FTA.

[0215] The FTA digital model 1100 may be derived at least in part based on data representing the teeth in the FTA. Such FTA data may include a digital representation of the desired final position and orientation of the patient's teeth relative to each other and to the gums. The FTA data may be obtained directly (e.g., generated by an operator) or received from an external source (e.g., the FTA data may be generated by a third party and provided to the operator to design an appropriate orthodontic appliance).

[0216] In some embodiments, FTA data can be obtained by manipulating OTA data to virtually move the patient's teeth. The operator can use suitable software, such as iROK Digital Dentastry Studio, to move the teeth to the desired FTA. In some embodiments, the virtual movement of the teeth relative to the OTA also results in movement of the gums relative to the OTA to maintain the natural appearance of the gums and more accurately reflect the orientation and position of the gums when the teeth are at the FTA. This movement of the gums can be achieved using gum deformation or other suitable techniques.

[0217] In some embodiments, the FTA may reflect changes to the patient's teeth that may occur as part of the treatment process. For example, as part of treatment, the operator may extract one or more of the patient's teeth due to insufficient space for all teeth to fit in the dental arch (or for other reasons). In this case, the extracted teeth may be excluded from the FTA data. If the operator determines that the teeth need to be made smaller due to insufficient space, an interproximal reduction (IPR) may be performed on the patient. In this case, the teeth may be stripped and reduced in size in the FTA to match the IPR performed by the operator.

[0218] In some embodiments, a proposed FTA may be developed by an operator (e.g., independently or based in whole or in part on input from an orthodontist) and then sent to the orthodontist for review and comment. If the treating orthodontist has comments, she may provide the operator with input that may be transmitted electronically or otherwise (e.g., written instructions, proposed manipulations of one or more teeth or fixed components, etc.). The operator may then modify the FTA and send the modified proposed FTA back to the orthodontist for further review and comment. This iterative process may be repeated until the orthodontist approves the proposed FTA, and the final digital model 1100.

[0219] Additionally or alternatively, the FTA digital model (e.g. Figure 8 ) can be manipulated to obtain a digital model of the fixing member 900 in the appropriate position to be coupled to the teeth. In some embodiments, the relative position of each fixing member with respect to its respective tooth can be obtained from the digital model 1000 ( Figure 10 ) is obtained or derived, wherein the fixing member is connected to the tooth in the OTA. In some embodiments, the fixing member may first be positioned on the tooth in the FTA to generate a digital model 1100 ( Figure 11 ), and this model can in turn be used to generate a digital model 1000 ( Figure 10 ), for example by manipulating the digital model 1100 to move the teeth OTA.

[0220] Back to Figure 5 , the process 500 continues at block 512 by determining the displacement of a single tooth or group of teeth between OTA and FTA. For example, the displacement of each tooth between OTA and FTA can be described using six degrees of freedom (e.g., translation along the X, Y, and Z axes, and rotation about the same three axes; or alternatively, translation in the mesiodistal, buccolingual, and / or occluso-gingival directions, and rotation in the form of buccolingual root torque, mesiodistal angulation, and / or mesiolateral internal rotation). In some embodiments, these values ​​can be determined by calculating the difference between the position of each tooth in the FTA data and the OTA data. This operation can be performed for each tooth in each jaw to generate a data set that includes the desired displacements of each tooth along the six degrees of freedom.

[0221] The process 500 continues at block 514 by obtaining a digital model of the heat treatment fixture. Figure 12 An example digital model of a fixture 1200 is shown, which can be manipulated by manipulating the digital model 1100 of the FTA ( Figure 11 ) generated. For example, the digital model 1100 can be manipulated to generate a digital representation of a fixture (e.g., a heat treatment fixture) for manufacturing an orthotic. The digital model 1100 can be manipulated in a variety of ways to generate appropriate fixture data. In some embodiments, such operations can be performed using suitable software, such as, MeshMixer.

[0222] In some examples, the fixation members in the digital model 1100 can be modified or replaced with appropriate fixation portions 1202, each configured to couple to an arm of the brace and facilitate temporary fastening of the brace to the jig. For example, a bracket-like fixation member can be replaced with a fixation portion 1202 comprising both a horizontal channel 1204 and a vertical channel 1206 configured to mate with the attachment portion 140 of the brace 100. A plurality of protrusions 1208 can be arranged along one or more side surfaces of the fixation portion 1202. The channels 1204 and 1206, along with the protrusions 1208, can provide a structure configured to receive a ligature or other fastener therethrough. For example, an operator can couple the brace 100 to the jig and then wrap a ligature through the horizontal channel 1204 and in the spaces between adjacent protrusions 1208 to secure the brace 100 in place against the jig. Additionally or alternatively, the horizontal channel 1204 can be configured to mate with the attachment portion 140 of the orthosis 100, for example, sufficiently deep (e.g., deeper than the corresponding channel of the fixation member 900 of the digital model 1100) to receive both the attachment portion 140 therein and a ligature or other fastener therethrough. In some embodiments, the vertical channel 1206 can be configured to mate with a portion of the attachment portion 140 of the orthosis 100, such that a single attachment portion 140 can be partially received within the horizontal channel 1204 and partially received within the vertical channel 1206. The protrusion 1208 can also define a groove or recess configured to receive a ligature or other elongated fastener. The fixture model 1200 can also define a through-channel or hole within each fixation portion 1202. These through-passages may allow a pushing tool to be inserted from the back of the fixation portion 1202 (e.g., through the buccal side of the jig model 1200) to push the attachment portion 140 away from the fixation portion 1202 after heat treatment has been completed and the ligatures or other fasteners have been removed.

[0223] Additionally or alternatively, the digital model 1100 can be manipulated to change the shape or configuration of the gums to generate the fixture model 1200. When the aligner is installed, if any part of the aligner hits the gums, the patient may experience considerable discomfort. Therefore, it is desirable to design an aligner that fits closely against the patient's gums without hitting the patient's gums. In some embodiments, this can be achieved by expanding the gums of the digital model 1100 to generate the fixture model 1200. For example, the lingual side of the gums in the digital model 1100 can be expanded (e.g., moved more lingually) by a predetermined amount (e.g., less than about 1.5 mm, less than about 1.4 mm, less than about 1.3 mm, less than about 1.2 mm, less than about 1.1 mm, less than about 1.0 mm, less than about 0.9 mm, less than about 0.8 mm, less than about 0.7 mm, less than about 0.6 mm, less than about 0.5 mm, less than about 0.4 mm, less than about 0.3 mm, less than about 0.2 mm, or less than about 0.1 mm). Similarly, when an appliance is generated using the surfaces of the fixture data (e.g., the appliance 100 can be shaped to substantially correspond to a portion of the lingual side of the fixture model 1100, as described in more detail below), the size and configuration of the appliance can be tailored to maintain a shorter distance from the patient's gums without impinging on the patient's gums.

[0224] Continuing with reference to block 514, the digital model 1100 with the attached fixture may be manipulated to remove teeth or other structural elements not required for heat treating the appliance, and / or to add structural features to strengthen the fixture for adequate rigidity during the heat treatment process. Figure 12 As shown, the fixture model 1200 does not include any teeth, but retains at least a portion of the gingival surface 1210. In addition, the fixture model 1200 includes a stabilizing crossbar 1212, which can increase the rigidity of the final fixture. Various other modifications can be made to the digital model 1100 to achieve the desired heat treatment fixture model 1200.

[0225] Return Reference Figure 5 The process 500 continues at block 516 by obtaining a digital model of the orthotic template. Figure 13 An example of an orthotic template digital model 1300 is shown, here shown in a configuration that matches the jig model 1200.

[0226] The model 1300 defines an anchor portion 1302, an arm portion 1304, and an attachment rod portion 1306. These components may take the form of a generic template for an orthosis that is subsequently customized for a specific patient (as discussed below with respect to Figure 15For example, the anchor portion 1302 may correspond to the anchor 120 of the completed brace, and the arm portion 1304 may serve as a placeholder for the arms 130 of the completed brace. The attachment rod portion 1306 may be in the form of a continuous strip connecting each arm 130. Figure 13 As shown, the arm portion 1304 can be configured to be received within the channel 1204 of the fixed portion 1202 of the jig model 1200. The attachment rod portion 1306 can partially correspond to a portion of the attachment portion 140 of the arm 130 of the completed orthosis.

[0227] In various embodiments, the aligner template digital model 1300 can be generated using the surface data of the jig model 1200. For example, the aligner template digital model 1300 can be configured to substantially correspond to the surface of the jig model 1200, such as, for example, the anchor portion 1302 corresponds to the contour of the jig model 1200 derived from data representing the patient's gingiva. As previously described, the treatment jig model 1200 can be modified relative to the OTA model 1100, specifically by enlarging the gingiva, for example. Thus, when the anchor portion 1302 contacts the gingiva portion of the jig model 1200, the anchor portion 1302 can be positioned slightly apart from the actual gingiva represented in the OTA model 700. In some embodiments, the aligner template model 1300 can have no thickness dimension, but rather correspond to a three-dimensional surface that follows the contour of the jig model 1200. In some embodiments, the aligner template model 1300 can have at least some thickness.

[0228] In block 518, the aligner template digital model 1300 may be flattened or otherwise manipulated to generate a planar aligner template model 1400 ( Figure 14 The planar template model 1400 may reflect two-dimensional or substantially planar data corresponding to or at least derived from the contoured aligner template model 1300. For example, the aligner template digital model 1300 ( Figure 13 ) is converted to a flat orthotic template model 1400 ( Figure 14 ), thereby generating a planar orthotic template model 1400. This can be done using a processor system and appropriate software (such as, but not limited to, Inventor, or other appropriate software) to perform such conversions.

[0229] At block 520 , a planar aligner digital model is obtained. Figure 15An example of a planar orthotic model 1500 is shown. At this stage, the planar template model 1400 ( Figure 14 ) to determine the specific shape and configuration of the arms of the orthosis. For example, the specific dimensions, geometry, and material properties of the arms of the orthosis can be selected so as to apply the necessary forces and / or torques to achieve the desired displacement determined at box 512. In some embodiments, a pre-populated library of arm designs can be used to select appropriate designs and configurations to achieve the desired displacement. In some embodiments, finite element analysis (FEA) or other techniques can be used to analyze the arm designs in the pre-populated library to determine the spring force that such arms will apply when deflected a specific amount (e.g., the amount of deflection between FTA (when the arms are at rest) and OTA). In some embodiments, the operator can review and / or modify the specific arm design that was selected fully or partially automatically based on relevant criteria. For example, if the proposed arm design includes arms that overlap or otherwise interfere, the operator can manually adjust the shape and / or configuration of the arms.

[0230] Based on the determined displacement, the force and / or torque required to move each tooth from OTA to FTA can be determined. The force required to move a tooth is typically in the centiNewton range, and the distance moved is typically in the millimeter range. The torque (Newton-millimeter) required to rotate the tooth can be calculated by multiplying the applied force by the moment arm. Typically, the displacement can be a 3D tooth movement that combines translational and rotational motion.

[0231] The force and / or torque required to achieve FTA may depend on the patient's anatomy, such as the size of the specific tooth being moved, the anatomy of the tooth root, etc. The force and / or torque may also depend on other physiological parameters (e.g., bone density, biological determinants, gender, race, jaw (maxilla or mandible), mechanical properties of the surrounding tissues surrounding the movable tooth (lips, tongue, gums and bones), etc.). The specific force and / or torque applied to a given tooth also depends on the specific positioning of the fixed member (such as the bracket). For example, under a given applied force, a fixed member positioned farther from the center-of-resistance of the tooth will generate more torque than a fixed member positioned closer to the center-of-resistance of the tooth. Based on the desired displacement (e.g., along the six degrees of freedom), the patient's anatomy and the position of the fixed member, a specific arm configuration can be selected to generate the desired force and / or torque on the target tooth to move the tooth from OTA to FTA. The appliance configuration that applies force and torque to the appropriate tooth to move the tooth to FTA is determined by determining the appropriate thickness, width, shape and configuration of the arms and other components of the orthodontic appliance.

[0232] In certain examples, the design of the aligner can be performed by an operator using a processor system and appropriate design software, such as, but not limited to, CAD software, such as, but not limited to, Inventor, FEA software (such as, but not limited to, Abaqus, Ansys, etc.) can be used to design the springs and arms to apply the desired or optimal force to the tooth. For example, such software and processing systems can be used to design and change the thickness, cutting width, length, and overall design of each arm based at least in part on the motion of the tooth to which the arm is attached.

[0233] In some examples, if the teeth need to be displaced a longer distance or the teeth are smaller (e.g., lower incisors), the arm 130 can be designed to be more flexible. In some embodiments, the selection or design of the arm 130 can take into account the variation in the speed of tooth movement based on direction. It is well known that when a given force is applied to a tooth, the speed of tooth movement varies depending on the direction of movement. For example, for a given force, extrusion is the fastest movement, intrusion is the slowest movement, and mesiodistal and buccal-lingual movement fall between these two extremes. In one example, under the same applied force, if a tooth moves 2 mm occlusally per month and 1 mm distally per month, the tooth will not move in a straight line because the occlusal movement will be faster than the distal movement. The occlusal movement will be completed first, and then the tooth will move in a straight line from there in the distal direction until the movement is complete. It may be desirable to move the tooth along a specific trajectory, and therefore the force applied distally may be different from the force applied occlusally. For example, it may be desirable to move the tooth in a straight line, so the distal force must be greater than the occlusal force to form a straight line trajectory from OTA to FTA.

[0234] In some embodiments, due to periodontal problems (such as bone resorption, root resorption, or attachment loss), the arm 130 may be designed to apply less force on some or all of the teeth. The ability to customize the force or torque (or both) applied to each tooth can provide significant advantages over traditional orthodontics. In a specific example, the computer-aided procedure uses an algorithm to select or configure the arm or other features of the braces, for example, from one or more predefined sets of options or one or more ranges of options. Thus, for example, a set of options or ranges of options can be predefined for one or more parameters associated with the arm or other features.

[0235] One or more parameters associated with the arm 130 may include, but are not limited to, the overall length of the arm, the shape or configuration of the biasing portion 150, the shape or configuration of the bracket connector 140, the width dimension of one or more sections of the arm 130, the thickness dimension of one or more sections of the arm 130, etc.

[0236] Obtaining the planar appliance digital model 1500 may also include determining the shape and configuration of the anchor 120. For example, the anchor 120 may be selected to substantially conform to the patient's gums without impinging thereon. The thickness, depth, or other characteristics of the anchor 120 may also be selected to provide sufficient stiffness for the forces generated by the arm. In some embodiments, the design of the anchor 120 may be automatically generated (e.g., by automatically generating to substantially conform to the patient's gums or other locations in the FTA model (e.g., model 1100) or OTA model (e.g., model 700 or 1000)). In some embodiments, the operator may manually select or modify the design and configuration of the anchor as needed.

[0237] Although in the illustrated embodiment, specific features of the arm 130 are selected when the brace model is substantially planar or 2D, in other embodiments, brace features may be selected and configured based on a digital model whose contours correspond to the patient's anatomy. For example, the 3D brace template model 1300 ( Figure 13 ) to select a specific arm 130, anchor 120, or any aspect thereof to achieve the desired orthosis. In some embodiments, the template is omitted entirely, and a customized orthosis model is generated based on the OTA model and / or the FTA model without the use of an intervening template model.

[0238] In some embodiments, the planar brace model 1500 can be 2D, so that the model does not define the thickness of the brace. For example, such a model can be used to cut a brace from a sheet of material. In this case, the thickness can be determined by selecting the sheet of material and by polishing, etching, grinding, deposition, or other techniques for adjusting the final thickness of the brace. In some embodiments, the planar brace model 1500 can define a thickness dimension while remaining substantially planar or flat. For example, the planar brace model 1500 can define the thickness of the brace, which can be uniform or can vary across some or all of the anchors 120 and arms 130.

[0239] In some embodiments, a 3D or contoured appliance model can be generated, for example, by manipulating the planar appliance model 1500 into a curved or contoured configuration. In some embodiments, the 3D appliance model can correspond to an appliance mounted on teeth in an OTA (e.g., by using the OTA model 1000 ( Figure 10) by manipulating the plane corrector model 1500 using the position data of the fixing member 900, or by using the FTA model 1100 ( Figure 11 ) in which the position data of the fixing member 900 is used to manipulate the plane corrector model 1500).

[0240] Referring to blocks 516, 518, and 520 together, in some examples, a computer-assisted program may be used to select or determine the shape and configuration of the arms, anchors, and / or any other features of the braces. The program may be configured to select one (or more) arms, fixing members, anchors, or parameters thereof, or any other aspect of the braces based on one or more input data. For example, the input data may include, but is not limited to, the type of tooth (e.g., molars, canines, incisors, etc.) or the size of the tooth. Larger teeth (e.g., molars) may require larger arms or larger, wider, or thicker annular or curved features to provide greater force than smaller teeth (e.g., incisors). Additionally or alternatively, the input data may include the size of the periodontal ligament (PDL) of one or more teeth. The size of the PDL may be obtained by any suitable process, including, but not limited to, CBCT scanning or other imaging techniques. Other input data may include, but is not limited to, the amount or direction of the force applied to one or more teeth in three-dimensional space. For example, the desired direction of tooth movement may require one or more arms to have a shape or configuration that is different from that required for a different direction of tooth movement. Other input data may include, but is not limited to, the amount or direction of the rotational force (or torque) applied to one or more teeth. For example, a desired tooth movement in a rotational direction may require one or more shapes or configurations of the arms to be different than the shapes or configurations required for a different direction of tooth movement. Additionally, in some embodiments, two or more arms may be attached to a single tooth, either with each arm coupled to a separate fixed member or with both arms coupled to the same fixed member. In this case, the input data may include the number of arms and / or fixed members coupled to each tooth, or alternatively, the number of arms and / or fixed members may be generated as output data.

[0241] In some embodiments, the computer-assisted program may include an algorithm that includes, but is not limited to, one or more values ​​representing one or more of the following as inputs: (a) up to three translational and up to three rotational movements from the OTA to the ITA or FTA, or from the ITA to another ITA or FTA; (b) the surface of the periodontal ligament (PDL) or the root area of ​​one or each tooth; (c) the patient's bone density; (d) biological determinants, e.g., obtained from saliva, gingival crevicular fluid (GCF), blood, urine, mucosa, or other sources; (e) the patient's sex; (f) the patient's race; (g) the jaw (maxilla or mandible) in which the appliance is to be installed; (i) the number of teeth to be installed; and (j) the mechanical properties of the bone and surrounding tissue (lips, tongue, gums) of the teeth to be moved. In various embodiments, one or more of these inputs may affect the force (e.g., magnitude, direction, contact point) required to move each tooth from the OTA to the FTA or toward the FTA.

[0242] In other examples, other suitable input data may be used. The computer-assisted procedure uses a computer programmed or configured with appropriate non-transient software, hardware, firmware, or a combination thereof to generate an output (e.g., one or more selected arm configurations, anchor configurations, or fixation member configurations) based on one or more input data.

[0243] The output generated by the computer-assisted program based on such input may include, but is not limited to, one or more of the following: (a) the design of the arms; (b) the width or cut width of one or more such arms; (c) any aligner portion or thickness dimensions of the entire aligner; (d) the mechanical properties of such arms, including, but not limited to, the amount of flexibility, or biasing force or resilience; (e) the design of the anchors; (f) the width or thickness of the anchors; (g) the connection location between the arms and the anchors; and / or (h) the transformation temperature of the nitinol (or other material) in one or more (or each) segments of the aligner. As previously described, in some embodiments, the output may include a specific configuration of anchors and / or arms selected from a pre-generated library. For example, based on the input, a desired force (e.g., magnitude and direction) may be determined for each tooth. Based on the desired force, an appropriate anchor member and / or arm configuration may be selected that provides the desired force or a suitable approximation thereof. In some embodiments, the configuration of the aligner (including any of the outputs listed above) may be generated independently of any pre-generated library. In some embodiments, generating the output may include analyzing a provisional selection or design using finite element analysis (FEA) or other techniques to determine performance parameters (e.g., the elastic force that such an arm will exert when deflected a particular amount, such as an amount of deflection between FTA (when the arm is at rest) and OTA).

[0244] In certain examples, a computer-assisted program can be used to create custom braces for each given patient. In other examples, braces can be manufactured in a plurality of predefined sizes, shapes, configurations, etc. based on a population group. Thus, a different semi-custom size, shape, or configuration can be configured to fit each different selected portion of the population group. In this way, a more limited number of different brace sizes, shapes, and configurations can be created to accommodate a relatively large portion of the population.

[0245] Based on the determined shapes and configurations of the arms and anchors, complete orthotic shape data can be generated. In some embodiments, the orthotic shape data can be in the form of 3D data (e.g., the orthotic in its shape-set form after heat treatment or other suitable shaping techniques) or in the form of planar or substantially 2D data (e.g., the orthotic in a laid-flat form, such as cut from a sheet of material).

[0246] At block 522, the aligner may be manufactured (e.g., based on the planar aligner digital model 1500 (block 520)). And at block 524, a heat treatment fixture may be manufactured (e.g., based on the heat treatment fixture digital model 1200 (block 514)). The manufacture of the heat treatment fixture and the aligner will be described in more detail below.

[0247] In some embodiments, generating complete appliance shape data may include obtaining a heat treatment fixture model (e.g., as described below with respect to Figure 12 ), and generating a preliminary appliance model based on the heat treatment fixture model. For example, the preliminary appliance model may conform to at least a portion of the lingual surface of the heat treatment fixture model. The preliminary appliance model may then be modified to include the defined arms and anchors, to have a defined thickness profile, etc. The modified appliance model may then be flattened for use in manufacturing, as described below.

[0248] How to make orthodontic appliances

[0249] As described above, one or more digital models (e.g., a flat orthotic digital model 1500 or a contoured orthotic digital model) representing or defining an orthotic device may be generated. In various embodiments, one or more such digital models may be used to manufacture an orthotic device for a patient. Figure 16 An example of an orthosis 100 manufactured using one or more digital models described herein is shown. Certain example manufacturing processes are described below. However, those skilled in the art will appreciate that any suitable manufacturing process may be used to manufacture the orthosis (or components thereof) disclosed herein.

[0250] In some embodiments, the orthodontic appliance 100 can be manufactured using a planar digital appliance model (e.g., planar appliance digital model 1500). For example, the planar appliance digital model can include planar or substantially two-dimensional shape data. The planar shape data can be provided to suitable manufacturing equipment (e.g., one or more machines that perform cutting, laser cutting, milling, chemical etching, wire electric discharge machining (EDM), water jetting, punching (stamping), etc.) to cut a flat sheet of material into a component having a shape corresponding to the planar appliance digital model 1500. The component can be cut from any suitable flat sheet of material, such as, but not limited to, nitinol, stainless steel, cobalt chrome, or other types of metals, polymers, superelastic materials, etc. The sheet of material can have a thickness selected to achieve the desired material properties of the resulting component. In various embodiments, the thickness of the sheet of material can be uniform or can vary (e.g., along a gradient, thinned in specific areas using etching, grinding, etc., or thickened in specific areas using deposition, etc.). In some examples, the thickness of the sheet of material can be between about 0.1 mm and about 1.0 mm, between about 0.2 mm and about 0.9 mm, between about 0.3 mm and about 0.8 mm, between about 0.4 mm and about 0.7 mm, or about 0.5 mm. In some embodiments, the thickness of the sheet of material can be less than about 1.5 mm, less than about 1.4 mm, less than about 1.3 mm, less than about 1.2 mm, less than about 1.1 mm, less than about 1.0 mm, less than about 0.9 mm, less than about 0.8 mm, less than about 0.7 mm, less than about 0.6 mm, less than about 0.5 mm, less than about 0.4 mm, less than about 0.3 mm, less than about 0.2 mm, or less than about 0.1 mm.

[0251] Next, the cutting member may be bent from its substantially planar shape into a contoured arrangement. Figure 16 An example of a completed appliance 100 resulting from such bending of the planar member is shown. As shown, and as described elsewhere herein, the appliance 100 can include an anchor 120 and a plurality of arms 130 extending away from the anchor 120. Each arm 130 can include an attachment portion 40 configured to cooperate with a fixed member adhered to a patient's teeth, and a biasing portion 150 disposed between the attachment portion 40 and the anchor 120. When the appliance 100 is installed in the patient's mouth, each arm 130 can be connected to a different one of the teeth to be moved and exert a specific force on its corresponding tooth, thereby allowing the operator to move each tooth independently.

[0252] In some embodiments, after being cut or otherwise formed from a sheet of material, the planar member can be bent or otherwise manipulated into a shape or contour corresponding to or substantially corresponding to the FTA configuration. For example, the member can be cut from a flat sheet of nitinol or other suitable material and have a generally flat configuration. The member can be bent into a desired 3D or contoured configuration, such as corresponding to the contoured digital model 1600 of the aligner. In some examples, one or more fixtures are provided for bending the planar member into the desired 3D shape. In such examples, after cutting the planar member, the planar member can be secured to or between one or more fixtures and bent or otherwise manipulated to form the desired 3D shape. In some embodiments, the thickness of the member can be modified, at least in certain portions, before or after cutting the member from the sheet of material to achieve desired material properties. For example, the thickness of at least some regions of the member can be reduced using milling, chemical etching, photolithography, wire electro-discharge machining, or any other suitable material removal process. The thickness of at least some regions of the member can be increased using thin film deposition, electroplating, or any other suitable additive technique. In some embodiments, the planar member can be formed using 3D printing or other techniques, as an alternative to or in addition to cutting the planar member from a sheet of material. 3D printing can offer certain advantages, such as ease of controlling the thickness of different portions of the aligner. In some embodiments, the planar member can be formed by 3D printing metal, polymer, or any other suitable material that can be additively manufactured using 3D printing.

[0253] In some embodiments, the shape of the brace can be fixed to a desired contoured or 3D configuration (e.g., corresponding to an FTA). During or after the bending operation, while maintaining the desired 3D shape, one or more shape-setting procedures (such as, but not limited to, heat treatment) can be applied to the brace to fix the desired 3D shape. Shape-setting procedures including heat treatments can include rapid cooling after heating the component during or after bending. Additional details regarding example heat treatments and associated fixtures are described below.

[0254] By using cut planar members, rather than traditional single-diameter wire, a wider variety of final 3D shapes can be produced compared to shapes produced by bending single-diameter wire. Cut planar members can have designed or varying widths and lengths, which, when bent into the desired shape, can allow portions of a 3D device to have varying thickness, width, and length dimensions. In this way, the planar member can be cut to provide the desired thickness, width, and length for the biasing portion, arm, or other component of the brace. A wider variety of shapes can be achieved by bending custom cut planar members compared to bent single-diameter wire.

[0255] In some examples, the entire orthosis (including arms and anchors) is manufactured by bending a cut planar member into the desired 3D-shaped member. In other examples, additional components can be attached to the 3D shape, for example, after bending. Such additional components can include, but are not limited to, attachment portion 40, biasing portion 150, arms 130, etc. Such additional components can be attached to the 3D-shaped member by any suitable attachment mechanism, including, but not limited to, adhesive materials, welding, friction fittings, etc.

[0256] In some embodiments, the braces can be directly 3D printed into a desired contour or 3D shaped configuration. In some embodiments, the 3D formed component can be 3D printed, for example, using any suitable material. In the case of using Nitinol to 3D print the braces, a shape-setting process (e.g., heat treatment) may not be required. In addition, 3D printing can allow the use of different geometries (e.g., the cross-sectional shape of the anchor member can be elliptical instead of rectangular, which can increase the patient's comfort on the gingival and lingual sides of the anchor).

[0257] Orthodontic appliance shaping method

[0258] As previously mentioned, in some embodiments, the heat treatment fixture model (e.g., the heat treatment fixture model 1200 ( Figure 12 )) can be used to generate a digital model of the orthotic device. For example, a planar digital model 1500 of the orthotic device can be obtained based at least in part on the heat treatment fixture model 1200. The heat treatment fixture model 1200 can also be used to manufacture a heat treatment fixture, which can then be used to shape the orthotic device (e.g., a planar member cut from a sheet of material can be formed into a desired 3D shape using a heat treatment fixture).

[0259] Figure 17 An example of a heat treatment fixture 1700 is shown. The fixture 1700 may be based on a heat treatment fixture digital model (e.g., fixture digital model 1200 ( Figure 12 )) manufacturing. For example, the digital model or related data can be provided to the manufacturing system to generate a physical model based on the fixture model. In one example, the fixture data can be used to 3D print a wax fixture model. The wax model can then be used to investment cast the fixture with brass or other suitable materials. In some embodiments, the fixture can be 3D printed directly with brass or other suitable materials (such as stainless steel, bronze, ceramic or other materials that can withstand the high temperatures required for heat treatment). Figure 17 As shown, the clamp 1700 may include a securing portion 1702 configured to mate with the attachment portion 40 of the orthosis 100 .

[0260] In some embodiments, the manufactured fixture can be used to heat-set the aligner. Figure 18 As shown, the combined assembly 1800 may include the brace 100 that has been bent or otherwise manipulated into a shape that abuts against the surface of the heat treatment fixture 1700. The brace 100 may be coupled to the fixture 1700 by placing the attachment portion of the arm into the fixing portion 1702 of the fixture. Ligatures 1802 or other suitable fasteners may be wrapped around the brace 100 at various locations to secure the brace 100 relative to the fixture 1700. Next, heat may be applied to heat-set the brace 100, and the brace 100 may then be removed from the fixture 1700.

[0261] One example of a heat treatment procedure may include heating the brace 100 to a selected temperature (e.g., but not limited to 525 degrees Celsius) for a selected time (e.g., but not limited to 20 minutes) and then rapidly cooling it. The rapid cooling may be achieved by any suitable cooling procedure, such as, but not limited to, water quenching or air cooling. In other examples, the time and temperature of the heat treatment may differ from those discussed above, for example, based on a particular treatment plan. For example, the heat treatment temperature may be in the range of 200 degrees Celsius to 700 degrees Celsius, and the heat treatment time may be in the range of approximately 120 minutes. Specifically, the heat treatment procedure may be performed in an air or vacuum furnace, a salt bath, a fluidized sandbed, or other suitable system. Upon completion of the heat treatment, the brace has a desired 3D shape and configuration (e.g., substantially corresponding to the heat treatment fixture and / or the desired FTA). In other examples, other suitable heat treatment procedures may be employed, including, but not limited to, resistive heating or heating by passing an electric current through the metal of the brace structure.

[0262] One or more additional post-processing operations may be provided on the 3D formed object, including but not limited to abrasive grit blasting, shot peening, polishing, chemical etching, electropolishing, plating, coating, ultrasonic cleaning, sterilization or other cleaning or decontamination processes.

[0263] In examples where the brace is comprised of multiple components, some (or each) of the components of the brace can be manufactured according to the methods described above and then joined together to form the desired 3D brace configuration. In these or other examples, the brace (or some or each of the components of the brace) can be manufactured using other suitable methods, including but not limited to: direct printing of metal; first printing a wax component and then investment casting the wax component into metal or other material; printing an elastomeric material or other polymer; cutting or machining a solid material; or cutting a component from sheet metal and shaping it into the desired 3D configuration.

[0264] As discussed herein, one or more heat treatment fixtures may be configured to be used to bend the cut planar member into a desired 3D shape configuration. In a specific example, one or more heat treatment fixtures are provided (e.g., but not limited to, customized) for each jaw of the patient. For example, the shape and configuration of the heat treatment fixture can be customized for each patient and can be manufactured in any suitable manner, including molding, machining, direct metal printing of stainless steel or other suitable metals, 3D printing of suitable materials, such as but not limited to stainless steel by powder bed fusion, or steel / copper mixture by binder jetting, and first printing the configuration with wax and then casting the wax into various metals. In the various examples described herein, the heat treatment fixture may be made of a material sufficient to resist the heat treatment temperature. In a specific example, one or more robots (robots, mechanical devices) may be used with or without one or more heat treatment fixtures to bend the cut planar member into a desired 3D shape configuration.

[0265] In some embodiments, a single shaping step may be performed to deform the component from its planar configuration to its desired 3D configuration. However, in certain embodiments, shaping may include two or more shaping steps (e.g., two or more heat treatment processes, possibly using two or more different heat treatment fixtures). In such cases, the amount of deformation applied to the brace within each shaping step may be limited, with each subsequent shaping step moving the brace further toward the desired three-dimensional configuration.

[0266] The completed appliance (optionally with a bonding tray and / or fixing components) can then be sent to the treating clinician. To install the appliance, the orthodontist cleans the lingual side of the patient's teeth and prepares them for bonding (e.g., with pumice). The tooth surface can then be sandblasted (e.g., using 50 micron aluminum oxide). The fixing components can then be attached using a bonding tray, as described elsewhere herein.

[0267] After the appliance is manufactured and the fixing member is attached to the teeth, each arm can be connected to its corresponding fixing member element to install the appliance. After installation, the appliance will apply force and torque on the teeth to move the teeth to the desired FTA. After treatment is completed (e.g., OTA to FTA, OTA to ITA, ITA to ITA, or ITA to FTA), the arms may be passively placed in the fixing member and no longer apply force to the teeth. Alternatively, any residual force applied by the arms may be below a threshold that causes further tooth displacement.

[0268] The patient can return for a review appointment (e.g., approximately 2-3 months), and if treatment is progressing as planned, no further procedures are performed until the patient returns at the scheduled time for appliance removal. At this stage, the fixed components can be removed. If treatment is not progressing as planned, the appliances can be removed, the patient's mouth re-scanned, and new appliances designed and fitted according to the revised treatment plan.

[0269] in conclusion

[0270] Although many embodiments have been described above primarily with respect to systems, devices, and methods for orthodontic appliances positioned on the lingual side of a patient's teeth, the technology is applicable to other applications and / or other methods, such as orthodontic appliances positioned on the facial side of a patient's teeth. Furthermore, other embodiments are within the scope of the technology in addition to those described herein. Furthermore, several other embodiments of the technology may have different configurations, components, or processes than those described herein. Therefore, one of ordinary skill in the art will accordingly understand that the technology may have other embodiments with additional elements, or the technology may have other embodiments without the above references. Figure 1A-18 Other embodiments of the several features shown and described.

[0271] The description of the embodiments of the present technology is not intended to be exhaustive, nor is it intended to limit the technology to the precise forms disclosed above. Where the context permits, singular or plural nouns may also include plural or singular nouns, respectively. For example, an embodiment described herein as using multiple coupling arms may also be modified to include fewer (e.g., one) or more (e.g., three) coupling arms. Although specific embodiments and examples of the above technology are described for illustrative purposes, various equivalent modifications may be made within the scope of the technology, as will be appreciated by those skilled in the relevant art. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0272] In addition, unless the word "or" is expressly limited to referring only to a single item in addition to other items in a list of two or more items, the use of "or" in such a list should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. In addition, "including" is always used to indicate that at least the described features are included so as not to exclude any greater number of additional types of the same features and / or other features. It should also be understood that specific embodiments are described herein for illustrative purposes, but various modifications can be made without departing from the technology. In addition, although the advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit these advantages, and not all embodiments need to exhibit these advantages to fall within the scope of the technology. Therefore, the present disclosure and related technology may include other embodiments not explicitly shown or described herein.

Claims

1. A method comprising: receiving OTA data representing gums and teeth of a patient in an original dental arrangement OTA; Create a digital FTA model representing the patient's gums and teeth in the final tooth arrangement FTA; creating a digital model of the heat treatment fixture based on the OTA data and the FTA data, the digital model comprising (a) a gingival surface and (b) at least one fixed portion representing a position of one or more of the patient's teeth in the FTA, each fixed portion defining a vertical channel; manufacturing a physical forming fixture based on the digital model of the heat treatment fixture; as well as releasably securing the anchors of the orthodontic appliance to the gingival surface of the physical forming fixture, and releasably securing the attachment portions of the orthodontic appliance within corresponding vertical channels of the fixing portion of the physical forming fixture, Wherein, the orthodontic appliance is configured to move the patient's teeth from OTA to FTA, such that the orthodontic appliance has a shape that is at least partially based on the shape of the heat treatment fixture.

2. The method of claim 1, wherein the gingival surface comprises a modified shape of the patient's gums.

3. The method of claim 1, wherein the fixation portion is configured to mate with an attachment portion of an orthosis. 4 . The method of claim 1 , wherein receiving the OTA data comprises receiving digital image data of an upper jaw and / or a lower jaw of a patient.

5. The method of claim 1 , further comprising generating a digital model of the orthodontic appliance, wherein the digital model of the orthodontic appliance has a shape based at least in part on a shape of the digital model of the heat treatment fixture. 6 . The method of claim 5 , wherein generating the digital model of the orthodontic appliance comprises conforming a portion of the digital model of the orthodontic appliance to a gingival surface of the digital model of the heat treatment fixture.

7. The method of claim 1 , further comprising manufacturing a physical heat treatment fixture based on the digital model of the heat treatment fixture.

8. The method of claim 7, wherein manufacturing the physical heat treatment fixture comprises one or more of molding, 3D printing, or casting.

9. The method of claim 7, further comprising securing an orthodontic appliance to the physical heat treatment fixture to change a shape of the orthodontic appliance. 10 . The method according to claim 9 , further comprising fixing the shape of the orthodontic appliance by applying heat treatment to the orthodontic appliance while the orthodontic appliance is fixed to the physical heat treatment jig.

11. A tangible, non-transitory computer-readable medium storing instructions that, when executed by one or more processors of a computing device, cause the computing device to: receiving, in the OTA, raw dental arrangement OTA data representing gums and teeth of a patient; Creating a FTA digital model of the final tooth arrangement representing the patient's gums and teeth in FTA; and Based on the OTA and FTA data, a digital model of a heat treatment fixture is created to set the shape of the orthodontic appliance installed in the patient's mouth to move the teeth from OTA to FTA, where The digital model is based on OTA data and FTA data, and wherein the digital model includes (a) a gingival surface, and (b) a plurality of fixed portions representing a position of one or more of the patient's teeth in the FTA, wherein each of the plurality of fixed portions defines a vertical channel that is physically configured to be releasably secured to the orthodontic appliance, A physical molding fixture is obtained based on the digital model of the heat treatment fixture, the anchor of the orthodontic brace is releasably fixed to the gingival surface of the physical molding fixture, and the attachment part of the orthodontic brace is releasably fixed in the corresponding vertical channel of the fixed part of the physical molding fixture.

12. The non-transitory computer-readable medium of claim 11, wherein: The fixing portion includes a plurality of digital fixing portions configured to releasably fix the orthodontic appliance to the heat treatment fixture.

13. The non-transitory computer-readable medium of claim 11, wherein: The operations also include modifying the shape of the gingival surface relative to the patient's gingiva.

14. The non-transitory computer-readable medium of claim 11, wherein: The operations also include generating a digital model of the orthodontic appliance having a shape based at least in part on the digital model of the heat treating fixture. 15 . The non-transitory computer-readable medium of claim 14 , wherein generating the digital model of the orthodontic appliance comprises positioning a portion of the digital model of the orthodontic appliance at a gingival surface of the digital model of the heat treatment fixture.

16. A method for forming a heat treatment fixture for forming the shape of an orthodontic appliance, the method comprising: receiving first data corresponding to a first three-dimensional shape of a patient's jaw, wherein the first data includes a digital original dental arrangement OTA of the patient's teeth and the patient's gums; obtaining second data corresponding to a second three-dimensional shape of the patient's jaw, wherein the second data includes a digital intermediate tooth arrangement (ITA) or a digital desired final tooth arrangement (FTA) of the patient's teeth and the patient's gums; obtaining a digital model of a heat treatment fixture configured to hold the orthodontic appliance in a configuration during a shaping process, the heat treatment fixture being customized for a patient based at least in part on the first data and the second data, wherein the digital model of the heat treatment fixture comprises: (a) a gingival surface and (b) a plurality of fixed portions, each fixed portion defining a vertical channel and having a position based at least in part on a position of a fixed member on the patient's teeth in an ITA or FTA, wherein the fixed portions are configured to engage one or more portions of the orthodontic appliance such that the one or more portions of the orthodontic appliance are positioned at a position based at least in part on the position of the fixed member on the patient's teeth in the ITA or FTA; and A physical forming fixture is obtained based on the digital model of the heat treatment fixture, wherein the anchor of the orthodontic brace is releasably fixed to the gingival surface of the physical forming fixture, and the attachment part of the orthodontic brace is releasably fixed in the corresponding vertical channel of the fixed part of the physical forming fixture.

17. The method according to claim 16, further comprising: obtaining an orthodontic appliance in a planar configuration, the orthodontic appliance comprising an anchor configured to be positioned adjacent a patient's teeth and a plurality of arms extending from a first end at the anchor to a second end distal to the anchor; as well as A second end of the arm proximate the attachment portion is secured to a securing portion of the heat treatment fixture such that the orthodontic appliance conforms to the heat treatment fixture.

18. The method of claim 17, further comprising setting the shape of the orthodontic appliance while securing the second end of the arm of the orthodontic appliance to a fixing portion of the heat treatment jig.

19. The method according to claim 17, wherein When the second end of the arm is engaged with the securing portion, the anchor conforms to the gingival surface of the heat treatment fixture.

20. The method according to claim 16, wherein The gingival surface characterizes the thickened pattern of the patient's gingiva.

21. The method according to claim 16, wherein The gingival surface has a contour corresponding to the contour of the patient's gingiva.

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