Method of designing a dental appliance

Abstract

This document discloses orthodontic appliances, systems, and methods. In some examples, the orthodontic appliance may include an anchor configured adjacent to a patient's teeth and a plurality of arms extending from and connected to the anchor, the arms being configured to be secured to the patient's teeth. According to embodiments of the present technology, a method for determining the design of an orthodontic appliance may include virtually deforming a digital model of the appliance based on an anatomical digital model, and modifying one or more digital models or generating a final design of the orthodontic appliance based on the output of the virtual deformation. If one or more digital models are modified, the method is repeated until a final design is generated.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 704,293, filed May 2, 2020, and U.S. Provisional Application No. 62 / 704,295, filed May 2, 2020, both of which are incorporated herein by reference in their entirety.

[0003] This application relates to the following applications, each of which is incorporated herein by reference in its entirety: U.S. Provisional Patent Application No. 62 / 956,290, entitled Orthodontic Appliance, Related System and Method of Use, filed January 1, 2020; U.S. Patent Application No. 16 / 865,323, entitled Dental Appliance, System and Method, filed May 2, 2020; International Patent Application No. PCT / US20 / 31211, entitled Dental Appliance, System and Method, filed May 2, 2020; and U.S. Patent Application No. 15 / 929,443, entitled Dental Appliance, Related System and Method of Use, filed January 1, 2020. Filed on May 2, 2020: U.S. Patent Application No. 15 / 929,444, entitled "Dental Orthodontic Appliance and Related Systems and Methods of Use"; International Patent Application No. PCT / US20 / 70017, entitled "Dental Orthodontic Appliance and Related Systems and Methods of Use"; U.S. Patent Application No. 15 / 929,442, entitled "Dental Orthodontic Appliance and Related Methods of Manufacturing"; and International Patent Application No. PCT / US20 / 70016, entitled "Dental Orthodontic Appliance and Related Methods of Manufacturing"; and International Patent Application No. PCT / US20 / 70016, entitled "Dental Orthodontic Appliance and Related Methods of Manufacturing". Technical Field

[0004] This technology relates to the field of orthodontics, and more specifically, to devices, systems, and methods for designing and manufacturing orthodontic appliances. Background Technology

[0005] A common goal of orthodontics is to move a patient's teeth to a position that is both functionally and aesthetically pleasing. To move teeth, orthodontists first obtain multiple scans and / or impressions of the patient's teeth to determine a series of orthodontic pathways between the initial and desired final positions. The orthodontist then fits the patient with one of two main types of appliances: braces or aligners.

[0006] Traditional braces consist of an archwire and brackets placed in front of the teeth, with the archwire secured to the brackets using elastic bands or sutures. In some cases, self-ligating brackets can be used instead of bands or sutures. The shape and stiffness of the archwire, as well as the interaction between the archwire and brackets, determine the force applied to the teeth, thus determining the direction and extent of tooth movement. To apply the required force to the teeth, orthodontists often manually bend the archwire. Orthodontists monitor patient progress through regular appointments, during which they visually assess treatment progress and manually adjust the archwire (e.g., with new bends) and / or replace or reposition the brackets. The adjustment process is time-consuming and tedious for patients and often causes discomfort for several days after the appointment. Furthermore, braces are not aesthetically pleasing, and brushing, flossing, and other dental hygiene procedures are difficult.

[0007] Orthodontic appliances consist of a clear, removable polymer shell with cavities shaped to receive and reposition teeth to produce a final tooth alignment. Known as "invisible braces," these appliances significantly improve a patient's aesthetics compared to braces. Orthodontic appliances do not require orthodontists to bend wires or reposition brackets and are generally more comfortable than braces. However, unlike braces, orthodontic appliances cannot effectively treat all malocclusions. Certain tooth repositioning steps, such as squeezing, translation, and certain rotations, may be difficult or impossible to achieve with appliances. Furthermore, because appliances are removable, treatment success is highly dependent on patient compliance, which can be unpredictable and inconsistent.

[0008] Lingual braces, as an alternative to traditional (buccal) braces, have become increasingly popular in recent years. Two examples of existing lingual braces are Incognito. TM Appliance Systems (3M USA) and (Swift HealthSystems, Irvine, California) Each lingual braces consists of a bracket and archwire placed on the lingual or tongue-side of the teeth. Compared to traditional braces, lingual braces are virtually invisible, and unlike orthodontic braces, they are fixed to the patient's teeth and enforced. However, these existing lingual techniques also have some drawbacks. Most notably, traditional lingual braces still rely on a bracket-archwire system to move teeth, thus requiring multiple appointments and painful adjustments. For example, lingual techniques have relatively short inter-bracket distances, which often makes the archwire less compliant (stiffer, stiffer). Therefore, the entire lingual braces are more sensitive to archwire adjustments and cause more pain for the patient. In addition, the lingual surface of the braces can irritate the tongue, affecting speech and making the braces difficult to clean.

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

[0010] For example, according to the various aspects described below, including references Figures 1A to 25 The subject matter technique is illustrated. For convenience, examples of various aspects of this subject matter technique are described as numbered entries (1, 2, 3, etc.). These are provided as examples and do not limit this subject matter technique.

[0011] Item 1. A method for designing orthodontic appliances, comprising:

[0012] Obtain anatomical digital models representing the gingiva and teeth of patients in the arrangement;

[0013] Obtain a digital model of the orthodontic appliance that represents the design of the appliance configured for use with the patient's teeth;

[0014] The digital model of the orthodontic appliance is virtually morphed to represent the configuration in which the appliance is connected to the patient's teeth in the alignment; and

[0015] Evaluate the variant configuration of the digital model of the orthodontic appliance.

[0016] Item 2. The method according to Item 1, wherein the orthodontic appliance comprises an appliance for repositioning one or more teeth of the patient.

[0017] Item 3. The method according to Item 1 or Item 2, wherein the orthodontic appliance includes an anchor and one or more arms, the anchor being configured to be disposed adjacent to the patient's teeth, the one or more arms extending away from the anchor, each of the one or more arms being configured to engage with a corresponding one or more of the patient's teeth.

[0018] Item 4. The method according to any one of Items 1 to 3, wherein the arrangement includes the original tooth arrangement.

[0019] Item 5. The method according to any one of Items 1 to 3, wherein the arrangement includes an intermediate tooth arrangement.

[0020] Item 6. The method according to any one of Items 1 to 3, wherein the arrangement includes the final tooth arrangement.

[0021] Item 7. The method according to any one of Items 1 to 6, wherein evaluating the deformed configuration includes determining whether the deformed digital model of the orthodontic appliance impacts the gingiva.

[0022] Item 8. The method according to any one of Items 1 to 7, wherein evaluating the deformed configuration includes evaluating the relative position of the digital model of the orthodontic appliance and the gingiva.

[0023] Item 9. The method according to any one of Items 1 to 8, wherein evaluating the modified configuration includes determining whether the distance between the appliance and the gingiva is greater than a predetermined threshold.

[0024] Item 10. The method according to any one of Items 1 to 9, wherein evaluating the deformed configuration includes determining whether any part of the deformed digital model of the orthodontic appliance exceeds the elastic strain limit.

[0025] Item 11. The method according to any one of Items 1 to 10, wherein evaluating the deformed configuration includes determining the difference between the force and / or torque applied to the teeth by the deformed appliance and the expected force and / or torque.

[0026] Item 12. The method according to Item 11, wherein evaluating the deformable configuration includes determining whether the difference between the force and / or torque applied to the teeth by the deformed appliance and the expected force and / or torque exceeds a predetermined precision limit.

[0027] Item 13. The method according to any one of Items 1 to 12, wherein evaluating the deformed configuration includes determining whether the force and / or torque applied to the teeth by the deformed orthodontic appliance exceeds a predetermined maximum force and / or torque.

[0028] Item 14. The method according to any one of Items 1 to 13 further includes modifying the digital model of the orthodontic appliance based on evaluation.

[0029] Item 15. The method according to Item 14, wherein modifying the digital model of the orthodontic appliance includes changing the configuration of at least one arm of the digital model of the orthodontic appliance.

[0030] Item 16. The method according to Item 14 or Item 15, wherein modifying the digital model of the orthodontic appliance includes changing the geometry of the conformal configuration of the digital model of the orthodontic appliance.

[0031] Item 17. The method according to any one of Items 14 to 16, wherein modifying the digital model of the orthodontic appliance includes changing the configuration of the anchors of the digital model of the orthodontic appliance.

[0032] Item 18. The method according to any one of Items 14 to 17, after modifying the digital model of the orthodontic appliance, further includes:

[0033] The modified digital model of the orthodontic appliance is virtually transformed into a configuration that allows the appliance to fit the patient's teeth; and

[0034] Evaluate the modified configuration of the digital model of the orthodontic appliance.

[0035] Item 19. The method according to any one of Items 1 to 18, wherein virtually deforming the orthodontic appliance includes performing finite element analysis (FEA) using a digital model of the orthodontic appliance.

[0036] Item 20. A method for designing an orthodontic appliance for repositioning a patient's teeth, the orthodontic appliance having an anchor and an arm extending away from the anchor, the method comprising:

[0037] Obtain anatomical digital models representing the gingiva and teeth of patients in the arrangement;

[0038] Obtain a digital model of the orthodontic appliance that characterizes the design; and

[0039] The digital model of the orthodontic device is virtually deformed based on the anatomical digital model.

[0040] Item 21. The method according to Item 20, wherein virtually deforming the orthodontic appliance model includes performing finite element analysis (FEA).

[0041] Item 22. The method according to Item 20 or Item 21 further includes obtaining output from a virtually deformed digital model of the orthodontic appliance based on an anatomical digital model.

[0042] Item 23. The method described in Item 22, wherein the output is a modified digital model of the orthodontic appliance.

[0043] Item 24. The method according to Item 22 or Item 23, wherein the output includes the position of a first portion of the orthodontic appliance digital model corresponding to the anchor of the orthodontic appliance relative to the position of the patient's gingiva in the anatomical digital model.

[0044] Item 25. The method according to any one of Items 22 to 24, wherein the output includes a measurement of strain in a digital model of the orthodontic appliance.

[0045] Item 26. The method according to any one of items 22 to 25 further includes determining whether the output is greater than a predetermined threshold.

[0046] Item 27. The method according to any one of items 22 to 26 further includes determining whether the output is less than a predetermined threshold.

[0047] Item 28. The method according to Item 26 or Item 27, wherein the predetermined threshold is the elastic strain limit.

[0048] Item 29. The method according to Item 26 or Item 27, wherein the predetermined threshold is the distance between the anatomical digital model and the orthodontic digital model.

[0049] Item 30. The method according to any one of items 22 to 29 further includes modifying the digital model of the orthodontic appliance based on the output.

[0050] Item 31. The method according to any one of items 22 to 30 further includes modifying the anatomical digital model based on the output.

[0051] Item 32. The method according to any one of items 20 to 31, wherein the arrangement is the original tooth arrangement.

[0052] Item 33. The method according to any one of items 20 to 32, wherein the arrangement is the desired final tooth arrangement.

[0053] Item 34. The method according to any one of items 20 to 33, wherein the arrangement is a middle tooth arrangement.

[0054] Item 35. The method according to any one of Items 20 to 34, wherein the digital model of the orthodontic appliance comprises a planar digital model of the orthodontic appliance that virtually represents the orthodontic appliance in a substantially planar form.

[0055] Item 36. The method according to any one of Items 20 to 34, wherein the digital model of the orthodontic appliance includes a prospective digital model of the orthodontic appliance that virtually represents the geometry of the orthodontic appliance in a morphological form.

[0056] Item 37. The method according to any one of Items 20 to 34, wherein the orthodontic appliance digital model includes a modified expected orthodontic appliance digital model, the modified expected orthodontic appliance digital model virtually representing the geometry of the orthodontic appliance in the installation form.

[0057] Item 38. A method for designing an orthodontic appliance for repositioning a patient's teeth, the orthodontic appliance having an anchor and at least one arm extending away from the anchor, the method comprising:

[0058] A planar orthodontic digital model is obtained, which virtually represents the orthodontic appliance in a substantially planar configuration;

[0059] A digital model of a heat-treated fixture is obtained, the digital model of which represents the geometry of the heat-treated fixture used for a shape-setting orthodontic appliance;

[0060] The first FEA was performed using a digital model of a planar orthodontic appliance and a digital model of a heat-treated fixture.

[0061] A digital model of the desired orthodontic appliance is obtained, which virtually represents the appliance in a three-dimensional configuration having a geometry at least partially based on a digital model of a heat-treated fixture.

[0062] Obtain an original tooth alignment (OTA) digital model, which virtually represents the patient's teeth and gums in the original alignment;

[0063] The second FEA was performed using the expected appliance digital model and the OTA digital model; and

[0064] Obtain the expected digital model and analysis results of the deformed orthodontic appliance.

[0065] Item 39. The method according to Item 38 further includes modifying the digital model of the planar orthodontic appliance based on the analysis results.

[0066] Item 40. The method according to Item 38 or Item 39 also includes modifying the digital model of the heat treatment fixture based on the analysis results.

[0067] Item 41. The method according to any one of Items 38 to 40, wherein performing the first FEA comprises:

[0068] Discretize at least one of the digital models of the planar orthodontic appliance and the heat treatment fixture into multiple finite elements and multiple nodes;

[0069] Assign material properties to at least one of the digital models of the planar orthodontic appliance and the heat-treated fixture;

[0070] The contact interaction between the digital model of the planar orthodontic appliance and the digital model of the heat-treated fixture is defined;

[0071] Assign boundary conditions to at least one of the digital models of the planar orthodontic appliance and the heat-treated fixture;

[0072] Limit the analysis parameters; and

[0073] Run FEA until the exit condition is met.

[0074] Item 42. The method according to Item 41, wherein assigning boundary conditions includes assigning non-zero displacement to the anchor portion of the digital model of the planar orthodontic appliance.

[0075] Item 43. The method according to Item 41 or Item 42, wherein assigning boundary conditions includes defining the relationship between the orientation of the arm of the digital model of the planar orthodontic appliance and the base plane of the fixed portion of the heat-treated fixture.

[0076] Item 44. The method according to Item 43, wherein the arm of the digital model of the planar orthodontic appliance is tangent to the base plane of the fixed portion of the heat-treated fixture.

[0077] Item 45. The method according to any one of items 41 to 44, wherein assigning boundary conditions includes assigning displacement to the attachment portion of the digital model of the planar orthodontic appliance.

[0078] Item 46. The method according to Item 45, wherein the displacement assigned to the attachment portion has an order of magnitude of zero.

[0079] Item 47. The method according to Item 45, wherein the displacement assigned to the attachment portion has a non-zero order of magnitude.

[0080] Item 48. The method according to items 38 through 47, wherein performing the second FEA comprises:

[0081] Discretize at least one of the expected orthodontic digital model and the OTA digital model into multiple finite elements and multiple nodes;

[0082] Assign material properties to at least one of the intended orthodontic digital model and the OTA digital model;

[0083] Define the contact interaction between the intended orthodontic appliance digital model and the OTA digital model;

[0084] Assign boundary conditions to at least one of the expected orthodontic digital model and the OTA digital model;

[0085] Limit the analysis parameters; and

[0086] Run the FEA until the exit condition is met.

[0087] Item 49. A method for designing an orthodontic appliance for repositioning a patient's teeth, the orthodontic appliance having an anchor and an arm extending away from the anchor, the method comprising:

[0088] Obtain an OTA digital model of the patient's teeth and gums in their original alignment, the OTA digital model including original position data of the teeth that will be repositioned by the orthodontic appliance when installed in the patient's mouth;

[0089] Obtain an FTA digital model of the patient's teeth and gums in the desired final arrangement, the FTA digital model including the final position data of the teeth;

[0090] Displacement data that determines the displacement between the original position data and the final position data of the tooth;

[0091] A digital model of the heat treatment fixture was obtained based on the FTA digital model.

[0092] A 3D template digital model is obtained based on the heat treatment fixture digital model, the heat treatment fixture digital model including a first part corresponding to the anchor of the orthodontic appliance in the treatment configuration and a second part corresponding to the arm in the treatment configuration;

[0093] Obtain a planar template digital model, wherein the planar template digital model is the basic planar configuration of the 3D template digital model;

[0094] A digital model of a planar orthodontic appliance is obtained based on the aforementioned planar template digital model;

[0095] Obtain a digital model of the intended orthodontic appliance, wherein the digital model of the intended orthodontic appliance is based on a digital model of a heat-treated clamp to characterize the orthodontic appliance in 3D configuration; and

[0096] Perform FEA on the OTA and the expected digital model of the orthodontic appliance to deform the expected digital model of the orthodontic appliance based on displacement data.

[0097] Item 50. The method according to Item 49, wherein obtaining the OTA digital model includes scanning the patient's teeth and gums.

[0098] Item 51. The method according to Item 50, wherein scanning the patient's teeth and gums includes optical scanning.

[0099] Item 52. The method according to Item 50, wherein scanning the patient's teeth and gums includes computed tomography (CT) scans.

[0100] Item 53. The method according to Item 50, wherein scanning the patient's teeth and gums includes scanning impressions of the patient's teeth and gums.

[0101] Item 54. The method according to any one of items 49 to 53 further includes segmenting the OTA digital model into multiple digital models of each tooth and at least one gingiva.

[0102] Item 55. The method according to any one of items 49 to 54 further includes obtaining a digital model of a fixation member representing a fixation member configured to adhere to a surface of a tooth and detachably engage with a portion of an orthodontic appliance to fix the orthodontic appliance to the tooth.

[0103] Item 56. The method according to Item 55 further includes obtaining an OTA having a digital model of the fixation member, the OTA comprising a combination of an OTA digital model and a digital model of the fixation member, wherein the combination is based on the desired arrangement of the fixation member on the patient's teeth during treatment when the orthodontic appliance is installed in the patient's mouth.

[0104] Item 57. The method according to Item 55 or Item 56 further includes obtaining an FTA with a fixed component digital model, the FTA comprising a combination of an FTA digital model and a fixed component digital model, wherein the combination is based on a desired arrangement.

[0105] Item 58. The method according to Item 56 or Item 57, wherein the desired arrangement of the fixing member is located on the lingual surface of the patient's teeth.

[0106] Item 59. The method according to Items 49 to 58, wherein the displacement data comprises three translations and three rotations.

[0107] Item 60. The method according to any one of Items 49 to 59, wherein obtaining the desired digital model of the orthodontic appliance comprises performing a feasibility study (FEA) using a planar orthodontic appliance digital model and a heat-treated fixture digital model.

[0108] Item 61. The method according to any one of Items 49 to 60, wherein the method further comprises modifying the digital model of the heat treatment fixture based on the digital model of the intended orthodontic appliance.

[0109] Item 62. The method according to Item 59, wherein modifying the digital model of the heat-treated fixture includes defining a tangential relationship between the gingival surface of the digital model of the heat-treated fixture and the gingival-facing surface of the digital model of the intended orthodontic appliance.

[0110] Item 63. The method according to any one of items 61 to 62 further includes manufacturing a planar template digital model.

[0111] Item 64. The method according to any one of items 1 to 63 further includes manufacturing a digital model of the heat treatment fixture.

[0112] Item 65. The method according to any one of items 1 to 64 further includes manufacturing a digital model of the intended orthodontic appliance.

[0113] Item 66. An orthodontic appliance manufactured according to the method described in any one of the items herein.

[0114] Item 67. A heat treatment fixture manufactured according to any one of the methods described in this item.

[0115] Item 68. A tangible, non-transitory computer-readable medium configured to store instructions that, when executed by one or more processors, cause the one or more processors to perform the method described in any one of these items.

[0116] Item 69. An apparatus comprising:

[0117] One or more processors; and

[0118] A tangible, non-transitory computer-readable medium configured to store instructions that, when executed by one or more processors, cause one or more processors to perform the method described in any one of the entries herein.

[0119] Item 70. A method for determining the arrangement of orthodontic appliances, the method comprising:

[0120] Obtain positional data corresponding to the patient's original tooth alignment (OTA);

[0121] Obtain positional data corresponding to the patient's first final tooth alignment (FTA), which differs from the OTA; and

[0122] Determine the location data corresponding to the second FTA, which is at least partially based on the first FTA and predetermined parameters, and differs from the first FTA.

[0123] The second FTA can be used to form a clamp and / or orthodontic appliance, which is configured to move the patient’s teeth from the OTA toward the first FTA or the second FTA.

[0124] Item 71. The method according to Item 70 further includes manufacturing the clamps and / or orthodontic appliances based at least on data corresponding to the second FTA.

[0125] Item 72. The method according to Item 70 or Item 71, wherein the orthodontic appliance is configured to substantially move the patient's teeth from the OTA to the first FTA or the second FTA.

[0126] Item 73. The method according to any one of Items 70 to 72, wherein the orthodontic appliance is configured to have an arrangement substantially corresponding to the second FTA, wherein the orthodontic appliance is in a substantially unloaded state.

[0127] Item 74. The method according to any one of items 70 to 73, wherein the orthodontic appliance is configured to have a first arrangement substantially corresponding to a second FTA and a second arrangement substantially corresponding to an OTA, the first arrangement corresponding to a substantially no-load state and the second arrangement corresponding to a loaded state.

[0128] Item 75. The method according to any one of Items 70 to 74, wherein predetermined parameters are associated with the expected movement of at least one tooth of the patient after it has been repositioned to the second FTA via an orthodontic appliance.

[0129] Item 76. The method according to Item 75, wherein the intended movement is in at least one of the mesio-distal direction, the lingual-facial direction, or the occlusal-gingival direction.

[0130] Item 77. The method according to Item 75 or Item 76, wherein the intended movement is a rotation about an axis defined by at least one of the mesial-distal direction, the lingual-facial direction, or the occlusal-gingival direction.

[0131] Item 78. The method according to any one of items 70 to 77 further includes manufacturing an orthodontic appliance such that the appliance in a substantially no-load configuration generally corresponds to a second FTA, wherein the first FTA corresponds to a predetermined desired position of the patient's teeth.

[0132] Item 79. The method according to any one of Items 70 to 78, wherein the expected relapse corresponds to the positional difference between the first FTA and the second FTA.

[0133] Item 80. A method for determining the arrangement of orthodontic appliances, the method comprising:

[0134] Obtain data corresponding to the patient's original tooth alignment (OTA); and

[0135] Data corresponding to the final tooth alignment (FTA) is determined based on OTA and predetermined parameters.

[0136] The FTA can be used to form clamps and / or orthodontic appliances, which are configured to move the patient's teeth from the OTA toward the FTA.

[0137] The predetermined parameters are based, at least in part, on the expected relapse after the patient’s teeth have been repositioned from the OTA.

[0138] Item 81. The method according to Item 80, wherein a minimum threshold force is required to move at least one of the patient's teeth by means of an orthodontic appliance, and wherein predetermined parameters are associated with the minimum threshold force.

[0139] Item 82. The method according to Item 80 or Item 81, wherein the orthodontic appliance has a configuration that generally corresponds to the second FTA in an unloaded state.

[0140] Item 83. The method according to any one of items 80 to 82, wherein the orthodontic appliance has a configuration generally corresponding to the second FTA in an unloaded state, and wherein the orthodontic appliance is configured to move the patient's teeth to the first FTA.

[0141] Item 84. The method according to any one of items 80 to 83, wherein the orthodontic appliance has a configuration in an unloaded state that substantially corresponds to the second FTA, and wherein the orthodontic appliance is configured to move the patient's teeth to the first FTA, rather than the second FTA.

[0142] Item 85. The method according to any one of Items 80 to 84, wherein:

[0143] A minimum threshold force is required to move at least one of the patient's teeth using an orthodontic appliance;

[0144] The predetermined parameters are associated with the minimum threshold force; and

[0145] The orthodontic appliance is configured to provide a non-zero force greater than a minimum threshold along a path defined at least by the OTA and the first FTA.

[0146] Item 86. The method according to any one of Items 80 to 85, wherein:

[0147] A minimum threshold force is required to move at least one of the patient's teeth using an orthodontic appliance;

[0148] The predetermined parameters are associated with the minimum threshold force; and

[0149] When in a configuration that typically corresponds to the first FTA, the orthodontist is configured to provide a non-zero force less than a minimum threshold.

[0150] Item 87. A method for determining the arrangement of orthodontic appliances, the method comprising:

[0151] Obtain data corresponding to the patient's original tooth alignment (OTA); and

[0152] Data corresponding to the final tooth alignment (FTA) is determined based on OTA and predetermined parameters.

[0153] The FTA can be used to form clamps and / or orthodontic appliances, which are configured to move the patient's teeth from the OTA toward the FTA.

[0154] This requires a minimum threshold force to move at least one of the patient's teeth via the orthodontic appliance, and

[0155] The predetermined parameters are associated with the minimum threshold force.

[0156] Item 88. The method according to Item 87, wherein the orthodontic appliance is configured to be coupled to a fixation member fixed to the patient's teeth, and wherein predetermined parameters are associated with a desired free clearance between the orthodontic appliance and the fixation member.

[0157] Item 89. The method according to Item 87 or Item 88, wherein the orthodontic appliance includes an attachment portion configured to be coupled to a fixation member fixed to the patient's teeth, and wherein predetermined parameters are associated with a desired free clearance between the attachment portion and the fixation member.

[0158] Item 90. The method according to any one of the items herein, wherein:

[0159] The orthodontic appliance includes an arm having an attachment portion configured to connect to a fixation member fixed to the patient's teeth.

[0160] The predetermined parameters are related to the free clearance between the attachment part and the fixing member, and the free clearance corresponds to the rotation angle that the attachment part can rotate relative to the fixing member, and

[0161] The second FTA differs from the first FTA at least in the rotation angle.

[0162] Item 91. The method according to Item 90, wherein the rotation angle is in a direction corresponding to at least one of the mesial, distal, occlusal, gingival, facial, and / or lingual directions.

[0163] Item 92. The method according to any one of the items herein, wherein:

[0164] The orthodontic appliance includes an arm having an attachment portion configured to connect to a fixation member fixed to the patient's teeth.

[0165] The predetermined parameters are related to the free clearance between the attachment portion and the fixed member, the free clearance corresponding to the dimension by which the attachment portion can move relative to the fixed member, and

[0166] The second FTA differs from the first FTA at least in size.

[0167] Item 93. The method according to Item 92, wherein the dimension extends in a direction corresponding to at least one of the mesial-distal, occlusal-gingival, and / or facial-lingual directions.

[0168] Item 94. The method according to any one of the items herein, wherein the arm of the orthodontic appliance is configured to be coupled to a fixation member fixed to the patient's teeth, and wherein predetermined parameters are associated with a desired free clearance between the arm and the fixation member.

[0169] Item 95. A method for determining the arrangement of orthodontic appliances, the method comprising:

[0170] Obtain data corresponding to the patient's original tooth alignment (OTA); and

[0171] Data corresponding to the final tooth alignment (FTA) is determined based on OTA and predetermined parameters.

[0172] The FTA can be used to form a clamp and / or orthodontic appliance having multiple arms that are configured to move the patient's teeth from the OTA toward the FTA when coupled to the patient's teeth via corresponding fixation members.

[0173] The predetermined parameters are based, at least in part, on the expected free clearance between at least one arm and the corresponding fixed member.

[0174] Item 96. The method according to any one of the items herein, wherein a predetermined parameter is associated with the positional difference between the first FTA and the second FTA.

[0175] Item 97. The method according to any one of the items herein, wherein the orthodontic appliance is configured to have a first arrangement corresponding to a first FTA, and the clamp is configured to have a second arrangement corresponding to a second FTA, and wherein predetermined parameters are associated with the difference between the first arrangement and the second arrangement.

[0176] Item 98. The method according to any one of the items herein further includes:

[0177] The fixture is manufactured to have an arrangement corresponding to the second FTA;

[0178] The orthodontic appliance is processed on the clamp so that the orthodontic appliance has an arrangement corresponding to the first FTA.

[0179] Item 99. The method according to any one of the items herein further includes:

[0180] The fixture is manufactured to have an arrangement corresponding to the second FTA;

[0181] The orthodontic appliance is manufactured with a 2D configuration;

[0182] Connect the orthodontic appliance to the clamp;

[0183] The orthodontic appliances are processed and positioned on the clamps so that they are arranged in an alignment corresponding to the second FTA; and

[0184] Disconnect the orthodontic appliance from the clamp, thereby arranging the orthodontic appliance in a manner corresponding to the first FTA.

[0185] Item 100. A method for determining the arrangement of orthodontic appliances, the method comprising:

[0186] Obtain data corresponding to the patient's original tooth alignment (OTA); and

[0187] Data corresponding to the final tooth alignment (FTA) is determined based on OTA and predetermined parameters.

[0188] The FTA can be used to form a clamp and / or orthodontic appliance configured to move the patient's teeth from the OTA toward the FTA, and

[0189] The predetermined parameters are associated with the expected plastic deformation threshold of the orthodontic appliance.

[0190] Item 101. The method according to any one of the items herein, wherein predetermined parameters are associated with the stress experienced by the orthodontic appliance during OTA.

[0191] Item 102. The method according to any one of the items herein, wherein predetermined parameters are associated with the material properties of the orthodontic appliance.

[0192] Item 103. The method according to any one of the items herein, wherein the orthodontic appliance comprises a hyperelastic material, and wherein predetermined parameters are associated with plastic deformation associated with the hyperelastic material.

[0193] Item 104. The method according to any one of the items herein, wherein the orthodontic appliance comprises nitinol, and wherein predetermined parameters and plastic deformation associated with nitinol are associated.

[0194] Item 105. The method according to any one of the items herein, wherein the orthodontic appliance comprises nitinol, and wherein predetermined parameters are associated with the hysteresis of nitinol.

[0195] Item 106. The method according to any one of the items herein, wherein predetermined parameters are associated with the stress experienced by the orthodontic appliance when in a configuration corresponding to at least one of OTA or FTA.

[0196] Item 107. The method according to any one of the items herein, wherein:

[0197] The predetermined parameters are related to the expected plastic deformation threshold of the orthodontic appliance.

[0198] The orthodontic appliance includes an anchor portion and an arm extending from the anchor portion, and

[0199] The plastic deformation threshold is related to the arm of the orthodontic appliance.

[0200] Item 108. The method according to any one of the items herein, wherein:

[0201] The predetermined parameters are related to the expected plastic deformation threshold of the orthodontic appliance.

[0202] The orthodontic appliance includes an anchor portion and an arm extending from the anchor portion, the arm including an offset portion, and

[0203] The plastic deformation threshold is related to the bias portion of the orthodontic appliance.

[0204] Item 109. The method according to any one of the items herein, wherein, when connected to a patient's teeth, the orthodontic appliance is configured to switch from a first configuration corresponding to the OTA, and wherein determining the data corresponding to the FTA includes determining whether a portion of the orthodontic appliance in the first configuration exceeds the yield strength of the material of the orthodontic appliance.

[0205] Item 110. The method according to any one of the items herein, wherein:

[0206] When the orthodontic appliance is attached to the patient's teeth, the appliance is configured to switch from a first configuration corresponding to the OTA, and

[0207] Determining the data corresponding to the FTA includes determining whether a portion of the orthodontic appliance in the first configuration exceeds the yield strength of the appliance's material.

[0208] Item 111. The method according to any one of the items herein, wherein, when connected to a patient's teeth, the orthodontic appliance is configured to switch from a first configuration corresponding to an OTA to a second configuration corresponding to an FTA, and wherein determining the data corresponding to the FTA includes determining whether a portion of the orthodontic appliance in the first or second configuration exceeds the yield strength of the material of the orthodontic appliance.

[0209] Item 112. A method for determining the arrangement of orthodontic appliances, the method comprising:

[0210] Obtain data corresponding to the patient's original tooth alignment (OTA); and

[0211] Data corresponding to the final tooth alignment (FTA) is determined based on OTA and predetermined parameters.

[0212] The FTA can be used to form a clamp and / or orthodontic appliance configured to move the patient’s teeth from the OTA toward the FTA.

[0213] Item 113. The method according to any one of the items herein, wherein the predetermined parameter is the predetermined parameter as described in any one of the items herein.

[0214] Item 114. A method of manufacturing an orthodontic appliance, the method comprising:

[0215] Obtain positional data corresponding to the patient's original tooth alignment (OTA);

[0216] Obtain positional data corresponding to the patient's desired final tooth alignment (FTA);

[0217] An orthodontic appliance is manufactured that, when installed in a patient's mouth, is configured to push the patient's teeth from the OTA to the FTA, wherein, when the appliance is attached to the patient's teeth in the FTA, the appliance applies a non-zero force to one or more of the patient's teeth, the non-zero force being below a minimum threshold force.

[0218] Item 115. A method of manufacturing an orthodontic appliance, the method comprising:

[0219] Obtain positional data corresponding to the patient's original tooth alignment (OTA);

[0220] Obtain positional data corresponding to the patient's desired final tooth alignment (FTA);

[0221] Manufacturing orthodontic appliances configured to move a patient's teeth from OTA towards FTA; and

[0222] The orthodontic appliance is shaped by applying it to a treatment clamp, such that the appliance presents a first configuration, the clamp having a shape deviating from the FTA, such that after the appliance is removed from the clamp, the appliance presents a second configuration, wherein at least a portion of the appliance deviates from the first configuration.

[0223] Item 116. A tangible, non-transitory computer-readable medium storing instructions that, when executed by one or more processors, cause the one or more processors to perform the method of any of the items herein.

[0224] Item 117. An apparatus comprising:

[0225] One or more processors; and

[0226] A tangible, non-transitory computer-readable medium storing instructions that, when executed by the one or more processors, cause the one or more processors to perform any of the methods described in this entry.

[0227] Item 118. An orthodontic appliance manufactured according to any one of the methods described in this item.

[0228] Item 119. A heat treatment fixture manufactured according to any one of the methods described in this item.

[0229] Item 120. A method of manufacturing an orthodontic appliance for repositioning a patient's teeth, the orthodontic appliance having an anchor and at least one arm extending away from the anchor, the arm including a proximal portion at the anchor and a distal portion configured to be secured to an orthodontic bracket, the method comprising:

[0230] Before repositioning the teeth using orthodontic appliances, first position data characterizing the first position of the patient's teeth are obtained;

[0231] After the teeth are repositioned using orthodontic appliances, second position data characterizing the second position of the patient's teeth are obtained;

[0232] After repositioning the teeth using orthodontic appliances and following the expected tooth movement, third positional data characterizing the patient's desired tooth position are obtained; and

[0233] The three-dimensional configuration of the orthodontic appliance is formed such that the distal portion of the arm of the appliance is located in the second position.

[0234] The orthodontic appliance is configured to reposition the teeth from a first position to a second position, such that after the teeth have moved according to the expected movement, the teeth are positioned in the desired position.

[0235] Item 121. The method according to Item 120, wherein the orthodontic appliance is configured to reposition the teeth from a first position to a second position along a path in a first direction.

[0236] Item 122. The method according to Item 120 or Item 121, wherein the intended movement of the teeth is along a path in a second direction opposite to the first direction.

[0237] Item 123. A method for designing an orthodontic appliance for repositioning a patient's teeth, the method comprising:

[0238] Obtain first positional data characterizing the initial position of the patient's teeth;

[0239] Obtain second positional data characterizing the expected position of the patient's teeth;

[0240] Obtain deformation data characterizing the expected deformation of the orthodontic appliance when it is released from the shape-setting fixture; and

[0241] Based on the first position data, the second position data, and the deformation data, orthodontic appliance data is obtained that characterizes the three-dimensional (3D) configuration of the appliance, so that the appliance is configured to reposition the teeth from their initial positions to their desired positions.

[0242] Item 124. The method according to Item 123, wherein the expected deformation is due to the hyperelastic properties of the orthodontic appliance.

[0243] Item 125. The method of Item 123 of Item 124, wherein the orthodontic appliance has an anchor and at least one arm extending away from the anchor, the arm including a proximal portion at the anchor and a distal portion configured to be fixed to an orthodontic bracket configured to be fixed to a patient's teeth, and wherein the distal portion of the arm is positioned in a 3D configuration different from the intended position of the teeth.

[0244] Item 126. The method according to any one of items 123 to 125, wherein when the orthodontic appliance is fixed to the shape setting fixture, the elasticity data characterizes the expected deformation of the orthodontic appliance after the shape of the orthodontic appliance is set.

[0245] Item 127. A method for designing an orthodontic appliance for repositioning a patient's teeth, the method comprising:

[0246] Obtain first positional data characterizing the initial position of the patient's teeth;

[0247] Obtain second positional data characterizing the expected position of the patient's teeth;

[0248] Obtain orthodontic data characterizing the pre-installed configuration of the orthodontic appliance;

[0249] Obtain deformation data characterizing the expected deformation of the orthodontic appliance from its pre-installation configuration to its installed configuration; and

[0250] Based on the first position data, the second position data, and the deformation data, modified orthodontic data of the pre-installed configuration characterizing the modification of the orthodontic appliance are obtained.

[0251] Item 128. The method according to Item 127, wherein the deformation data characterizes stress and / or strain in one or more portions of the orthodontic appliance.

[0252] Item 129. The method according to Item 127 or Item 128 further includes determining whether plastic deformation is expected to occur at one or more portions of the orthodontic appliance due to expected deformation of the appliance from a pre-installation configuration to an installation configuration.

[0253] Item 130. The method according to Item 129, wherein determining whether plastic deformation is expected includes comparing deformation data with at least one of the yield stress or yield strain of the material of the orthodontic appliance.

[0254] Item 131. The method according to any one of Items 127 to 130, wherein the modified pre-installation configuration is a first modified pre-installation configuration, and after obtaining the modified orthodontic appliance data, the method further comprises:

[0255] Obtain second deformation data characterizing the orthodontic appliance from the pre-installation configuration of the first modification to the installed configuration, representing the expected deformation; and

[0256] Based on the first position data, the second position data, and the deformation data, second modified orthodontic data of the pre-installed configuration characterizing the second modification of the orthodontic appliance is obtained.

[0257] Item 132. A method of designing an orthodontic appliance for repositioning a patient's teeth, the orthodontic appliance having an anchor and at least one arm extending away from the anchor, the arm including a proximal portion at the anchor and a distal portion configured to be received within a fixed portion of an orthodontic bracket, the method comprising:

[0258] First positional data characterizing the initial position of the patient's teeth is obtained before repositioning the teeth using orthodontic appliances;

[0259] After the teeth are repositioned using orthodontic appliances, second positional data characterizing the expected position of the patient's teeth are obtained;

[0260] Obtain arm data that characterizes the dimensions of the distal portion of the arm of the orthodontic appliance;

[0261] Obtain bracket data that characterizes the dimensions of the fixing portion of the orthodontic bracket;

[0262] Obtain gap data representing the difference between the arm data and the bracket data;

[0263] Based on the gap data, force data characterizing the expected force applied by the orthodontic appliance to the bracket are obtained; and

[0264] Based on force data, third positional data is obtained to characterize the passive position of the distal portion of the arm of the orthodontic appliance after it has been shaped, the passive position being different from the expected position and / or the original position of the tooth.

[0265] Item 133. The method according to Item 132 further includes forming a three-dimensional configuration of the orthodontic appliance such that the distal portion of the arm of the orthodontic appliance is positioned at a second position.

[0266] Item 134. The method according to Item 132 or Item 133, wherein obtaining the clearance data includes determining the expected maximum angular displacement between the plane of the distal portion of the arm and the plane of the fixed portion of the bracket.

[0267] Item 135. The method according to any one of Items 132 to 134, wherein obtaining the force data includes determining the expected torque loss parameter associated with the connection between the distal portion of the arm and the fixed portion of the bracket.

[0268] Item 136. The method according to any one of items 132 to 135, wherein the arm data characterizes at least two of the following: the occlusal gingival size of the distal portion of the arm, the buccal-lingual size of the distal portion of the arm, or the mesiodistal size of the distal portion of the arm.

[0269] Item 137. The method according to any one of Items 132 to 136, wherein the bracket data characterizes at least two of the following: the occlusal gingival dimension of the fixed portion of the bracket, the buccal-lingual dimension of the fixed portion of the bracket, or the mesial-distal dimension of the fixed portion of the bracket.

[0270] Item 138. The method according to any one of items 132 to 137, wherein obtaining the gap data includes calculating the expected maximum distance between the distal portion of the arm and the fixed portion of the bracket.

[0271] Item 139. A method of manufacturing an orthodontic appliance for repositioning a patient's teeth, the orthodontic appliance having an anchor and at least one arm extending away from the anchor, the arm including a proximal portion at the anchor and a distal portion configured to be fixed to an orthodontic bracket, the orthodontic bracket being fixed to the patient's teeth, the method comprising:

[0272] First positional data characterizing the patient's teeth's original position is obtained before repositioning the teeth using orthodontic appliances;

[0273] After repositioning the teeth using orthodontic appliances, second positional data characterizing the expected position of the patient's teeth are obtained; and

[0274] The shape of the orthodontic appliance is set such that when the distal portion of the arm is fixed to the bracket fixed to the tooth and the appliance has repositioned the tooth to its intended position, the appliance applies a force to the tooth, the magnitude of which is greater than a predetermined threshold.

[0275] Item 140. According to the method of Item 139, wherein the predetermined threshold is greater than zero.

[0276] Item 141. The method according to Item 139 or Item 140, wherein the predetermined threshold is between about 5 grams and about 150 grams.

[0277] Item 142. The method according to any one of items 139 to 141, wherein after the shape of the appliance is set, the distal portion of the arm is positioned in a passive position, which differs from the intended position and / or the original position of the teeth.

[0278] Item 143. The method according to any one of items 139 to 142, wherein the predetermined threshold is unique for the tooth.

[0279] Item 144. A method for designing an orthodontic appliance for repositioning a patient's teeth, the method comprising:

[0280] Obtain a digital model of the orthodontic appliance representing the initial configuration;

[0281] Obtain a digital model of the clamp representing the clamp used to set the shape of the orthodontic appliance; and

[0282] A finite element analysis (FEA) is performed to virtually deform the digital model of the orthodontic appliance based on the digital model of the fixture.

[0283] Item 145. The method according to Item 144, wherein the digital model of the fixture comprises:

[0284] The gingival portion has a shape that substantially corresponds to the patient's gingival surface; and

[0285] At least one fixed portion, which is supported by the gingival portion and configured to retain a portion of the orthodontic appliance.

[0286] Item 146. The method according to Item 144 or Item 145, wherein performing the FEA includes making at least a portion of the orthodontic digital model substantially conform to the fixture digital model.

[0287] Item 147. The method according to any one of Items 144 to 146, wherein the orthodontic appliance includes an anchor and an arm extending away from the anchor, the arm including a proximal portion at the anchor and a distal portion configured to be fixed to an orthodontic bracket, and wherein performing the FEA includes positioning the distal portion of the arm of the orthodontic appliance digital model at or within a fixed portion of the clamp digital model.

[0288] Item 148. The method according to any one of Items 144 to 147, wherein the orthodontic appliance includes an anchor and an arm extending away from the anchor, and wherein performing the FEA includes applying a non-zero displacement to the anchor of the orthodontic appliance digital model.

[0289] Item 149. The method according to any one of Items 144 to 148, wherein the orthodontic appliance is substantially planar in the initial configuration.

[0290] Item 150. A method for designing an orthodontic appliance for repositioning a patient's teeth, the method comprising:

[0291] Obtain a digital model of the orthodontic appliance representing the pre-installed configuration;

[0292] Obtain anatomical digital models representing the patient's teeth and gingiva in the original arrangement; and

[0293] Perform FEA to virtually deform the orthodontic digital model based on the anatomical digital model.

[0294] Item 151. The method according to Item 150, wherein the orthodontic appliance includes an anchor and an arm extending away from the anchor, the arm including a proximal portion at the anchor and a distal portion configured to be fixed to the orthodontic bracket, and wherein performing FEA includes positioning the distal portion of the arm at or adjacent to one of the patient's teeth.

[0295] Item 152. The method according to Item 150 or Item 151, wherein the orthodontic appliance has a basic three-dimensional (3D) shape in the pre-installed configuration.

[0296] Item 153. The method according to any one of Items 150 to 152 further includes a digital model of the orthodontic appliance for evaluating deformation.

[0297] Item 154. The method according to Item 153, wherein evaluating the deformed digital model of the orthodontic appliance includes determining whether the deformed digital model of the orthodontic appliance impacts the gingiva or is spaced from the gingiva by more than a predetermined threshold.

[0298] Item 155. The method according to Item 153 or Item 154, wherein evaluating the deformed configuration includes determining whether any part of the deformed orthodontic digital model exceeds the elastic strain limit.

[0299] Item 156. The method according to any one of Items 153 to 155, wherein evaluating the deformed configuration includes determining the difference between the force and / or torque applied to the teeth by the deformed appliance and the expected force and / or torque.

[0300] Item 157. The method according to any one of Items 153 to 156 further includes modifying the digital model of the orthodontic appliance based on the evaluation, wherein modifying the digital model of the orthodontic appliance includes changing at least one of the shape of the arm of the orthodontic appliance, the shape of the anchor of the orthodontic appliance, or the shape of the orthodontic appliance in the pre-installed configuration.

[0301] Item 158. A method for designing an orthodontic appliance for repositioning a patient's teeth, the method comprising:

[0302] A preliminary digital model of the orthodontic appliance is obtained, which virtually represents the orthodontic appliance in its initial configuration.

[0303] A digital model of a heat-treated clamp is obtained, the digital model representing the geometry of the heat-treated clamp for shape-setting orthodontic appliances, wherein the heat-treated clamp includes a gingival surface and a fixation portion, the shape of the gingival surface substantially corresponding to the shape of the patient's gingival surface, and the fixation portion is configured to releasably retain a portion of the orthodontic appliance;

[0304] Perform a first FEA to virtually deform the preliminary orthodontic digital model based on the heat-treated fixture digital model;

[0305] A digital model of the intended orthodontic appliance is obtained, at least in part, based on the digital model of the heat-treated fixture, the digital model of the intended orthodontic appliance virtually representing the orthodontic appliance in a three-dimensional configuration having a geometric shape;

[0306] Obtain a digital model of the original tooth alignment (OTA), which virtually represents the patient's teeth and gums in the original alignment;

[0307] Perform a second FEA to virtually deform the intended orthodontic appliance digital model based on the OTA digital model; and

[0308] Obtain the expected digital model and analysis results of the deformed orthodontic appliance.

[0309] Item 159. The method according to Item 158, wherein the orthodontic appliance is substantially planar in the initial configuration.

[0310] Item 160. The method according to Item 158 or Item 159, wherein performing the first FEA includes:

[0311] At least one of the preliminary orthodontic digital model and the heat treatment fixture digital model is discretized into multiple finite element elements and multiple nodes;

[0312] Assign material properties to at least one of the preliminary orthodontic digital model and the heat-treated fixture digital model;

[0313] The contact interaction between the preliminary orthodontic appliance digital model and the heat-treated fixture digital model is defined;

[0314] Assign boundary conditions to at least one of the preliminary orthodontic digital model and the heat-treated fixture digital model;

[0315] Limit the analysis parameters; and

[0316] Run the FEA until the exit condition is met.

[0317] Item 161. The method according to Item 160, wherein assigning the boundary conditions includes assigning at least one of assigning a non-zero displacement of a portion of the planar orthodontic digital model or defining the relationship between the orientation of a portion of the planar orthodontic digital model and the base plane of the fixed portion of the heat-treated fixture.

[0318] Item 162. The method according to Item 158, wherein performing the second FEA comprises:

[0319] Discretize at least one of the expected orthodontic digital model and the OTA digital model into multiple finite elements and multiple nodes;

[0320] Assign material properties to at least one of the intended orthodontic digital model and the OTA digital model;

[0321] Define the contact interaction between the intended orthodontic appliance digital model and the OTA digital model;

[0322] Assign boundary conditions to at least one of the expected orthodontic digital model and the OTA digital model;

[0323] Limit the analysis parameters; and

[0324] Run the FEA until the exit condition is met.

[0325] Item 163. The method according to Item 162, wherein assigning the boundary conditions comprises assigning displacement to a portion of the intended orthodontic appliance digital model, the displacement being at least partially based on the movement of the patient's teeth from their original alignment to the desired final alignment.

[0326] Item 164. The method according to any one of Items 158 to 163, wherein the analysis result includes at least one of strain in the digital model of the deformed expected orthodontic appliance or the distance between the digital model of the deformed expected orthodontic appliance and the gingival surface of the patient.

[0327] Item 165. The method according to any one of Items 158 to 164, wherein the orthodontic appliance includes an anchor and at least one arm extending away from the anchor, the arm including a proximal portion at the anchor and a distal portion configured to be fixed to the orthodontic bracket.

[0328] Item 166. The method according to Item 165, wherein performing the first FEA causes the anchor of the orthodontic appliance to be positioned at or adjacent to the gingival surface of the heat-treated fixture digital model.

[0329] Item 167. The method according to Item 165, wherein performing the second FEA causes the distal portion of the arm of the orthodontic appliance to be positioned at or adjacent to one of the patient's teeth.

[0330] Item 168. A method for designing an orthodontic appliance for repositioning a patient's teeth, the method comprising:

[0331] Obtain an OTA digital model of the patient's teeth and gums in their original alignment, the OTA digital model including original position data of the teeth that will be repositioned by the orthodontic appliance when installed in the patient's mouth;

[0332] Obtain an FTA digital model of the patient's teeth and gums in the desired final arrangement, the FTA digital model including the final position data of the teeth;

[0333] Displacement data that characterizes the displacement between the original position data and the final position data of the tooth;

[0334] A heat treatment fixture digital model is obtained based on at least one of the OTA digital model or the FTA digital model;

[0335] A 3D template digital model is obtained based on the aforementioned heat treatment fixture digital model;

[0336] Obtain a planar template digital model, wherein the planar template digital model is the basic planar configuration of the 3D template digital model;

[0337] A digital model of a planar orthodontic appliance is obtained based on the aforementioned planar template digital model;

[0338] Obtain a digital model of the intended orthodontic appliance, wherein the digital model of the intended orthodontic appliance is characterized in 3D configuration based on the digital model of the heat-treated fixture;

[0339] Perform FEA on the OTA and the expected orthodontic appliance digital model to deform the expected orthodontic appliance digital model based on the displacement data; and

[0340] Evaluate the analysis results of the virtual deformation.

[0341] Item 169. The method according to Item 168, wherein the displacement data comprises three translations and three rotations.

[0342] Item 170. The method according to Item 168 or Item 169 further includes modifying the heat-treated fixture digital model based on the expected orthodontic digital model.

[0343] Item 171. The method according to Item 170, wherein modifying the digital model of the heat-treated fixture includes defining a tangential relationship between the gingival surface of the digital model of the heat-treated fixture and the gingival-facing surface of the digital model of the intended orthodontic appliance.

[0344] Item 172. The method according to any one of Items 168 to 171 further includes manufacturing at least one of the planar template digital model, the heat-treated fixture digital model, or the intended orthodontic appliance digital model.

[0345] Item 173. The method according to any one of Items 168 to 172, wherein the orthodontic appliance includes an anchor and an arm extending away from the anchor, the arm including a proximal portion at the anchor and a distal portion configured to be secured to an orthodontic bracket. Attached Figure Description

[0346] Many aspects of this disclosure can be better understood by referring to the following figures. The components in the figures are not necessarily to scale. Rather, the focus is on clearly illustrating the principles of this disclosure.

[0347] Figure 1A A schematic diagram of an orthodontic appliance configured according to the present technology is shown, which is installed in the patient's mouth adjacent to the patient's dentition.

[0348] Figure 1B This is a schematic diagram of connection configuration options configured according to an embodiment of the present technology.

[0349] Figure 1C This is a schematic diagram of a portion of an orthodontic appliance configured according to an embodiment of the present technology.

[0350] Figure 2A and Figure 2B This is a front view of an orthodontic appliance configured according to several embodiments of the present technology, which is installed in the maxilla and mandible of a patient's mouth, with the patient's teeth in the original tooth arrangement and the final tooth arrangement, respectively.

[0351] Figure 3 This is a flowchart of an example process for manufacturing orthodontic appliances according to the present technology.

[0352] Figure 4 This is a schematic block diagram of a system for manufacturing orthodontic appliances according to the present technology.

[0353] Figure 5 This is a flowchart of the process for designing orthodontic appliances based on this technology.

[0354] Figure 6 The image shows a scan of the patient's teeth to obtain raw tooth alignment data.

[0355] Figure 7 An example of a digital model of a patient's teeth and gums in their original tooth arrangement is shown.

[0356] Figure 8 An example of a digital model of a patient's teeth and gums in the final tooth alignment is shown.

[0357] Figure 9 An example of a digital model of a fixed component is shown.

[0358] Figure 10 An example of a digital model of a patient's teeth and gums in their original tooth arrangement, along with several fixation components, is shown.

[0359] Figure 11 An example of a digital model of a patient's teeth and gums in the final tooth alignment, along with multiple fixation components, is shown.

[0360] Figure 12 An example of a digital model of a heat treatment fixture is shown.

[0361] Figure 13 An example of a digital model of a three-dimensional orthodontic appliance template based on a heat-treated fixture model is shown.

[0362] Figure 14 An example of a digital model of a substantially planar orthodontic appliance template is shown.

[0363] Figure 15 An example of a digital model of a substantially planar orthodontic appliance with a unique arm geometry based on a defined displacement of each tooth is shown.

[0364] Figure 16 A perspective view of an orthodontic appliance according to an embodiment of the present technology is shown.

[0365] Figure 17 A perspective view of a heat-treated clamp for orthodontic appliances according to the present technology is shown.

[0366] Figure 18 This is a perspective view of an orthodontic appliance fastened to a heat-treated clamp according to this technology.

[0367] Figure 19 This is a flowchart of an example process for determining the design of orthodontic appliances.

[0368] Figure 20 This is a flowchart of an example process for determining the design of orthodontic appliances.

[0369] Figure 21 An example of the expected digital model of the orthodontic appliance is shown, obtained by performing finite element analysis using a digital model of the planar orthodontic appliance and a digital model of the heat-treated fixture.

[0370] Figure 22 An example of a deformed digital model of the expected orthodontic appliance is shown, obtained by performing finite element analysis using a digital model of the expected appliance and an OTA digital model.

[0371] Figure 23 An example of the results of finite element analysis is shown.

[0372] Figure 24 Another example of the analysis results is shown.

[0373] Figure 25 An example of the results from iterative finite element analysis is shown.

[0374] Figure 26 It is a graph showing the relationship between the force applied to the patient's teeth and the position of the patient's teeth.

[0375] Figure 27 This is a flowchart of a method for determining data corresponding to the arrangement of orthodontic devices according to an embodiment of the present technology.

[0376] Figure 28A This is a perspective view of a fixing member according to an embodiment of the present technology. Figure 28B It is a link according to an embodiment of the present technology to Figure 28A A perspective view of a portion of the arm of an orthodontic appliance on a fixed component; Figure 28C According to embodiments of the present technology Figure 28B An enlarged side view of the fixation components and orthodontic appliance shown.

[0377] Figure 29A This is a perspective view of a fixing member according to an embodiment of the present technology. Figure 29B It is a link according to an embodiment of the present technology to Figure 29A A perspective view of a portion of the arm of an orthodontic appliance on a fixed component; Figure 29C According to embodiments of the present technology Figure 23 An enlarged side view of the fixation components and orthodontic appliance shown in Figure B.

[0378] Figure 30 This is a flowchart of a method for determining data corresponding to the arrangement of orthodontic devices according to an embodiment of the present technology.

[0379] Figure 31 This is a flowchart of a method for determining data corresponding to the arrangement of orthodontic devices according to an embodiment of the present technology.

[0380] Figure 32 This is a side perspective view of an orthodontic appliance configured according to an embodiment of the present technology.

[0381] Figure 33This is a flowchart of a method for determining data corresponding to the arrangement of orthodontic devices according to an embodiment of the present technology.

[0382] Figure 34 This is a flowchart of a method for determining data corresponding to the arrangement of orthodontic devices according to an embodiment of the present technology. Detailed Implementation

[0383] This technology generally relates to orthodontic appliances and related systems configured to reposition one or more teeth of a patient. In specific embodiments, this technology relates to devices, systems, and methods for attaching or securing orthodontic appliances to teeth, and related methods for designing and manufacturing such appliances. Reference is made below. Figure 1A – Figure 34 Specific details of several embodiments of the present technology are described below.

[0384] I, definition

[0385] The terms used in this document to provide anatomical orientation or direction are intended to encompass different orientations of orthodontic appliances installed in the patient's mouth, regardless of whether the described structure is shown in the accompanying drawings as being installed in the mouth. For example, "mesial" refers to the direction along the patient's curved dental arch toward the patient's facial midline; "distal" refers to the direction along the patient's curved dental arch away from the patient's facial midline; "occlusal" refers to the direction toward the patient's teeth's masticatory surfaces; "gingival" refers to the direction toward the patient's gums or gingiva; "facial" refers to the direction toward the patient's lips or cheeks (this may be used interchangeably with "buccal" and "lip"); and "lingual" refers to the direction toward the patient's tongue.

[0386] As used herein, the terms "proximal" and "distal" refer to locations closer to 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 to and farther from the reference connector, respectively, along lines passing through the center of the cross-section of the portion of the orthodontic appliance branching from the reference connector.

[0387] As used herein, the terms “general,” “substantially,” “approximately,” and similar terms are used as approximate terms rather than terms of degree and are intended to describe the inherent variations in measured or calculated values ​​as would be recognized by one of ordinary skill in the art.

[0388] As used herein, the term “operator” means a clinician, practitioner, technician, or any person or machine that designs or manufactures orthodontic appliances or parts thereof, and / or facilitates the design or manufacture of appliances or parts thereof, and / or any person or machine associated with the placement of the appliance in a patient’s mouth and / or with any subsequent treatment of the patient associated with the appliance.

[0389] As used in this article, the term “force” refers to the magnitude and / or direction of a force, torque, or a combination thereof.

[0390] II. Overview of Orthodontic Appliances in This Technology

[0391] Figure 1A This is a schematic diagram of an orthodontic appliance 100 (or "applied appliance 100") configured according to an embodiment of the present technology, shown as being located in the patient's mouth and adjacent to the patient's teeth. Figure 1B This is an enlarged view of a portion of orthodontic appliance 100. Appliance 100 is configured to be mounted in a patient's mouth to apply force on one or more teeth to reposition all or some of them. In some cases, appliance 100 may be additionally or alternatively configured to maintain the position of one or more teeth. Figure 1A and 1B As schematically shown, the orthodontic appliance 100 may include a deformable member comprising one or more attachment portions 140 (each attachment portion schematically indicated by a box), each attachment portion being configured to be directly or indirectly secured to a tooth surface via a fixation member 160. The orthodontic appliance 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”). For ease of illustration, in Figure 1A Only two attachment portions 140 and two connectors 102 are marked in the document. As discussed herein, the number, configuration, and location of the connectors 102 and attachment portions 140 can be selected to provide the desired force on one or more teeth when the appliance 100 is installed.

[0392] The attachment portion 140 may be configured to be detachably coupled to the fixation member 160, which is bonded, adhered, or otherwise secured to the surface of one of the teeth to be moved. In some embodiments, one or more of the attachment portions 140 may be directly bonded, adhered, or otherwise secured to the respective tooth without requiring a fixation member or other connection interface at the tooth. Different attachment portions 140 of a given orthodontic appliance 100 may have the same or different shapes, the same or different sizes, and / or the same or different configurations. The attachment portion 140 may include any of the attachment portions, bracket connectors, and / or male connector elements disclosed in U.S. Patent Publication No. 2017 / 0156823A1, which is incorporated herein by reference in its entirety.

[0393] The orthodontic appliance 100 may include any number of attachment portions 140 adapted to securely attach the appliance 100 to one or more teeth of a patient to achieve desired movement. In some examples, multiple attachment portions 140 may be attached to a single tooth. The orthodontic appliance 100 may include attachment portions 140 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 orthodontic appliance 100 may be configured to engage one, two, three, four, five, or more connectors 102.

[0394] As previously described, connector 102 may include one or more first connectors 104 that extend directly between attachment portions 140. When the orthodontic appliance 100 is installed in a patient's mouth, the one or more first connectors 104 may extend along a generally mesiodistal dimension. In these and other embodiments, the orthodontic appliance 100 may include one or more first connectors 104 that extend along a generally occlusal gingival dimension and / or buccolingual dimension when the orthodontic appliance 100 is installed in a patient's mouth. In some embodiments, the orthodontic appliance 100 does not include any first connectors 104.

[0395] Additionally or alternatively, connector 102 may include one or more second connectors 106 extending between one or more attachment portions 140 and one or more connectors 102. When the orthodontic appliance 100 is installed in a patient's mouth, the one or more second connectors 106 may extend along a generally occlusal gingival dimension. In these and other embodiments, the orthodontic appliance 100 may include one or more second connectors 106 extending along a generally mesiodistal dimension and / or buccolingual dimension when the orthodontic appliance 100 is installed in a patient's mouth. In some embodiments, the orthodontic appliance 100 does not include any second connectors 106. In such embodiments, the orthodontic appliance 100 will only include a 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 (e.g., Figure 1A and Figure 1B (arm 130 in the document). In some embodiments, a plurality of second connectors 106 may extend from the same location along the orthodontic appliance 100 to the same attachment portion 140. In this case, the plurality of second connectors 106 and the attachment portion 140 together constitute an "arm," as used herein. Using two or more connectors to connect two points on the orthodontic appliance 100 allows for the application of a greater force (relative to a single connector connecting the same point) without increasing strain on the single connector. This configuration is particularly advantageous given the spatial constraints of the fixed displacement treatment here.

[0396] Additionally or alternatively, connector 102 may include one or more third connectors 108 extending between two or more other connectors 102. When the orthodontic 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 orthodontic appliance 100 may include one or more third connectors 108 extending along a generally occlusal gingival dimension and / or buccolingual dimension when the orthodontic appliance 100 is installed in the patient's mouth. In some embodiments, the orthodontic appliance 100 does not include any third connectors 108. One, some, or all of the third connectors 108 may be gingivally adjacent to one, some, or all of the first connectors 104. In some embodiments, the orthodontic appliance 100 includes a single third connector 108 extending along at least two adjacent teeth and providing a common connection to two or more second connectors 106. In several embodiments, the orthodontic appliance 100 includes a plurality of discontinuous third connectors 108, each third connector extending along at least two adjacent teeth.

[0397] like Figure 1A As shown, in some embodiments, the orthodontic appliance 100 may be configured such that when the appliance 100 is placed in a patient's mouth, all or a portion of one, some, or all of the connectors 102 are positioned near the patient's gingiva. For example, one or more third connectors 108 may be configured such that all or a portion of one or more third connectors 108 are positioned below the patient's gingival line and adjacent to but spaced apart from the gingiva. In many cases, providing a small gap (e.g., 0.5 mm or less) between the third connectors 108 and the patient's gingiva may be beneficial, as contact between the (multiple) third connectors 108 (or any portion of the appliance 100) and the gingiva may cause irritation and patient discomfort. In some embodiments, all or a portion of the (multiple) third connectors 108 are configured to make direct contact with the gingiva when the appliance 100 is placed in the patient's mouth. Additionally or alternatively, all or a portion of one or more first connectors 104 and / or second connectors 106 may be configured to be positioned near the gingiva.

[0398] According to some embodiments, one or more connectors 102 may extend between an attachment portion 140 or connector 102 and a connector 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 connector and a second connector, the first connector comprising (a) two or more connectors 102, (b) two or more attachment portions 140, or (c) at least one attachment member and at least one connector 102, and the second connector 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. An example of a connector 102 extending between a connector (a) between a second connector 106 and a third connector 108 and a connector (b) between a second connector 106 and an attachment portion 140 is provided. Figure 1B It is schematically shown and labeled as 109.

[0399] Each connector 102 can be designed to have a desired stiffness, such that a single connector 102 or a combination of connectors 102 applies a desired force on one or more teeth. In many cases, the force applied by a given connector 102 can be governed by Hooke's Law or F = k × x, where F is the restoring force applied 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 appliance 100, the stiffness coefficient along that path is zero and no force is applied. In this case, the individual connectors 102 of this technology can have different non-zero stiffness coefficients. For example, one or more connectors 102 can be rigid (i.e., the stiffness coefficient is infinite), such that the connector 102 will not bend or buckle between its two endpoints. In some embodiments, one or more connectors 102 can be "flexible" (i.e., the stiffness coefficient is non-zero and positive), such that the connector 102 can deform to apply (or absorb) forces on the associated one or more teeth or other connectors 102.

[0400] In some embodiments, including one or more rigid connectors between two or more teeth may be advantageous. The rigid connector 102 is sometimes referred to herein as a “rigid bar” or “anchor.” Each rigid connector 102 may have sufficient rigidity to maintain and retain its shape and resist bending. The rigidity of the connector 102 can be achieved by selecting specific shapes, widths, lengths, thicknesses, and / or materials. For example, a connector 102 configured to be relatively rigid may be used when the tooth to be connected to the connector 102 or arm is not moving (or moves by a limited amount) and can be used for anchoring. For example, molars can provide good anchoring because they have larger roots than most teeth, thus requiring greater force to move. Furthermore, anchoring one or more portions of the appliance 100 to multiple teeth is safer than anchoring to a single tooth. As another example, rigid connections may be desired when moving a group of teeth relative to one or more other teeth. For example, consider a situation where there is a gap between a patient’s five teeth and one tooth, and the treatment plan is to close that gap. The best treatment approach is usually to move one tooth towards the five teeth, rather than the other way around. In this case, providing one or more rigid connectors between the five teeth may be advantageous. For all the reasons mentioned above and many other reasons, the orthodontic 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.

[0401] In these and other embodiments, the orthodontic appliance 100 may 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 may 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 including one or more elastically flexible bias portions 150. Figure 1B As schematically shown, one, some, or all of the connectors 102 may include one or more bias portions 150 (e.g., springs), each bias portion being configured to apply a custom force specific to the teeth to which it is attached.

[0402] like Figure 1C As shown in the schematic diagram, (multiple) bias portions 150 may extend in whole or in part along the longitudinal axis L1 of the respective connector 102. Figure 1C Only the longitudinal axis L1 of the second connector 106 and the longitudinal axis L2 of the third connector 108 are marked in the diagram. The direction and magnitude of the force and torque applied to the teeth by the bias portion 150 depend at least in part on the shape, width, thickness, length, material, shape setting conditions, and other parameters of the bias portion 150. Thus, one or more aspects of the bias portion 150 (including the parameters mentioned above) can be changed such that when the appliance 100 is installed in the patient's mouth, the corresponding arm 130, connector 102, and / or bias portion 150 produce the desired tooth movement. Each arm 130 and / or bias portion 150 can be designed to move one or more teeth in one, two, or all three translational directions (i.e., mesiodistal, buccolingual, and occlusal gingival) and / or in one, two, or all three rotational directions (i.e., buccolingual root torque, mesiodistal angulation, and mesial out-inrotation).

[0403] The bias portion 150 of this technology can have any length, width, shape, and / or size sufficient to move the corresponding tooth toward a desired position. In some embodiments, one, some, or all of the connectors 102 may have one or more inflection points along the corresponding bias portion 150. The connectors 102 and / or the bias portion 150 may have a serpentine configuration, such that the connectors 102 and / or the bias portion 150 fold back onto themselves at least once or more before extending toward the attachment portion 140. For example, in some embodiments, the second connector 106 folds back twice along the bias portion 150 to form a first recess and a second recess facing substantially different directions relative to each other. The open loop or overlapping portion of the connector 102 corresponding to the bias portion 150 may be provided in the bisecting arm 130 and / or the total width W of the connector 102. Figure 1C plane P( Figure 1C On either side of the arm 130 and / or connector 102, the additional length of the arm 130 and / or connector 102 is accommodated by the space in the middle and / or distal end 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, although the space in the occlusal gingiva or vertical dimension between the location where any associated third connector 108 is attached to the tooth and the arm 130 is limited.

[0404] It should be understood that the bias portion 150 may have other shapes or configurations. For example, in some embodiments, the connector 102 and / or the bias portion 150 may include one or more linear regions that zig-zag toward the attachment portion 140. One, some, or all of the connector 102 and / or the bias portion 150 may have only linear segments or regions, or may have a combination of curved and linear regions. In some embodiments, one, some, or all of the connector 102 and / or the bias portion 150 may not include any curved portions.

[0405] According to some examples, a single connector 102 may have a plurality of bias portions 150 connected in series along the longitudinal axis of the respective connector 102. In some embodiments, the plurality of connectors 102 may extend between two points along the same or different paths. In such embodiments, different connectors 102 may have the same stiffness or different stiffness.

[0406] In embodiments where the orthodontic appliance 100 has two or more connectors 102 with bias 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, as well as other characteristics. In some embodiments, not all connectors 102 have bias portions 150. For example, a connector 102 without bias portions 150 may include one or more rigid connectors located between a rigid third connector 108 and an attachment portion 140. In some embodiments, none of the connectors 102 of the orthodontic appliance 100 have bias portions 150.

[0407] According to some embodiments, such as Figure 1A As schematically depicted herein, the orthodontic appliance 100 may include a single, continuous, substantially rigid third connector (referred to as “anchor 120”) and a plurality of flexible arms 130 extending away from the anchor 120. When the appliance 100 is fitted in the patient’s mouth, each arm 130 may connect to a different tooth among the teeth to be moved and apply a specific force to 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, making the movement of one tooth an unintentional movement of one or more nearby teeth. As discussed in more detail herein, the independent and customized tooth movement achieved by the appliance of this technique allows the operator to move teeth more effectively from the original dentition (“OTA”) to the final dentition (“FTA”), thereby avoiding periodic adjustments, reducing the number of visits, and reducing or eliminating patient discomfort, and reducing the total treatment time (i.e., the length of time the appliance is in the patient’s mouth) by at least 50% compared to the total treatment time of conventional braces.

[0408] Anchor 120 may include any structure of any shape and size, configured to fit comfortably within a patient's mouth and provide common support for one or more arms 130. In many embodiments, when the appliance 100 is fitted within a patient's mouth, the anchor 120 is positioned near the patient's gums, for example, as... Figure 1B As shown. For example, the orthodontic appliance may be designed such that, when installed in a patient's mouth, all or a portion of the anchor 120 lies below the patient's gingival line, adjacent to but spaced from the gingiva. In many cases, providing a small gap (e.g., 0.5 mm or less) between the anchor 120 (or any portion of the orthodontic appliance 100) and the patient's gingiva may be beneficial, as contact between the anchor 120 and the gingiva can cause irritation and patient discomfort. In some embodiments, all or a portion of the anchor 120 is configured to contact the gingiva when the orthodontic appliance 100 is placed in the patient's mouth.

[0409] Anchor 120 can be significantly more rigid than arms 130, such that the equal and opposite forces experienced by each arm 130 when force is applied to its corresponding tooth are canceled out by the rigidity of anchor 120 and the forces applied by the other arms 130, without meaningfully affecting the forces on other teeth. In this way, anchor 120 effectively isolates the forces experienced by each arm 130 from the rest of the arms 130, thereby enabling independent tooth movement.

[0410] According to some embodiments, such as Figure 1A and Figure 1B As schematically shown, anchor 120 includes an elongated member having a longitudinal axis L2 (see [reference]). Figure 1C The anchor 120 is formed into an arc shape, which is configured to extend along the patient's jaw when the appliance 100 is installed. In these and other embodiments, the shape and size of the anchor 120 may be configured to span two or more of the patient's teeth when positioned in the patient's oral cavity. In some examples, the anchor 120 includes a rigid linear bar, or may include a structure having linear segments and curved segments. In these and other embodiments, the anchor 120 may extend laterally across all or part of the patient's oral cavity (e.g., across all or part of the palate, across all or part of the mandible, etc.) and / or extend in a generally anteroposterior direction. Furthermore, the appliance 100 may include a single anchor or multiple anchors. For example, the appliance 100 may include multiple discrete, spaced-apart anchors, each anchor having two or more arms 130 extending therefrom. In these and other embodiments, the appliance 100 may include one or more other connectors extending between adjacent arms 130.

[0411] Any and all features discussed above regarding anchor 120 are applicable to any third connector 108 disclosed herein.

[0412] like Figure 1B As shown, each arm 130 may extend between a proximal end or first end 130 and a distal end or second end 130b, and may have a longitudinal axis L extending between the first end 130a and the second end 130b. The first end 130a of one, some, or all of the arms 130 may be disposed at the anchor 120. In some embodiments, one, some, or all of the arms 130 are integral with the anchor 120 such that the first end 130a of the arm is continuous with the anchor 120. The arms 130 may extend from the anchor 120 at intervals along the longitudinal axis L2 of the anchor 120, such as... Figure 1AAs shown. In some embodiments, the arms 130 may be spaced apart from each other at a uniform interval or at a non-uniform interval along the longitudinal axis L2 of the anchor 120.

[0413] One, some, or all of the arms 130 may include an attachment portion 140 at or near the second end 130b. In some embodiments, such as... Figures 1A to 1C As shown, one or more arms 130 are suspended from anchors 120 such that the second end 130b of one or more cantilever 130 has a free distal portion 130b. In these and other embodiments, the distal end of the attachment portion 140 may coincide with the distal end of the arm 130. The attachment portion 140 may be configured to detachably engage the respective arm 130 with a fixing member (e.g., a bracket) that is bonded, adhered, or otherwise secured to the surface of one of the teeth to be moved. In some embodiments, the attachment portion 140 may be directly bonded, adhered, or otherwise secured to the respective tooth without requiring a fixing member or other connection interface at the tooth.

[0414] Still referencing Figure 1A and Figure 1B One, some, or all of the arms 130 may include one or more resilient flexible bias portions 150, such as springs, each bias portion 150 being configured to apply a customized force, torque, or combination of force and torque specific to the tooth to which it is attached. The bias portions 150 may extend in whole or in part along the longitudinal axis L1 of the respective arm 130 between the anchor 120 and the attachment portion 140. The direction and magnitude of the force and torque applied to the tooth by the bias portions 150 depend at least in part on the shape, width, thickness, length, material, shape setting conditions, and other parameters of the bias portions 150. Thus, one or more aspects of the arms 130 and / or the bias portions 150 (including the parameters described above) can be altered such that when the appliance 100 is mounted in the patient's mouth, the arms 130 and / or the bias portions 150 produce the desired tooth movement. Each arm 130 and / or offset portion 150 may be designed to move one or more teeth in one, two, or all three translational directions (i.e., mesiodistal, buccal-lingual, and occlusal gingiva) and / or in one, two, or all three rotational directions (i.e., buccal-lingual root torque, mesiodistal angular, and mesiolateral-inner rotation).

[0415] The biasing portion 150 of this technology can have any length, width, shape, and / or size sufficient to allow the corresponding tooth to move toward the desired FTA. In some embodiments, one, some, or all arms 130 may have one or more bends along their respective biasing portions 150. The arms 130 and / or biasing portions 150 may have a serpentine configuration such that the arms 130 and / or biasing portions 150 fold back onto themselves at least once or more before extending toward the attachment portion 140. Figure 1B In this configuration, arm 130 folds back twice along the offset portion 150, forming a first and second recess facing generally different directions relative to each other. The open loop or overlapping portion of arm 130 corresponding to the offset portion 150 can be positioned on either side of the plane P bisecting the total width W of arm 130, such that the additional length of arm 130 is accommodated by space on the inner and / or distal ends of arm 130. This allows arm 130 to have a longer length (compared to a linear arm) to accommodate greater tooth movement, although the space in the occlusal gingiva or vertical dimension between the anchor 120 and the position where arm 130 is attached to the tooth is limited.

[0416] It should be understood that the bias portion 150 may have other shapes or configurations. For example, in some embodiments, the arm 130 and / or the bias portion 150 may include one or more linear regions that bend toward the attachment portion 140. One, some, or all of the arms 130 and / or the bias portion 150 may have only linear segments or regions, or may have a combination of curved and linear regions. In some embodiments, one, some, or all of the arms 130 and / or the bias portion 150 may not include any curved portions.

[0417] According to some examples, a single arm 130 may have multiple bias portions 150. The multiple bias portions 150 may be connected in series along the longitudinal axis L1 of a respective arm 120. In some embodiments, the multiple arms 130 may extend parallel between two points along the same path or along different paths. In such embodiments, the different arms 130 may have the same stiffness or different stiffnesses.

[0418] In embodiments where the orthodontic appliance 100 has two or more arms 130 with bias portions 150, some, none, or all 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, not all arms 130 have bias portions 150. For example, an arm 130 without a bias portion 150 may include one or more rigid connections located between the anchor 120 and the attachment portion 140. In some embodiments, none of the arms 130 of the orthodontic appliance 100 have bias portions 150.

[0419] The orthodontic appliance of this technology may include any number of arms 130 adapted to reposition a patient's teeth while taking into account patient comfort. Unless expressly defined as a specific number of arms in the specification, the orthodontic appliance of this technology may 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 appliance may be configured to individually connect to more than one tooth (i.e., a single arm 130 may be configured to connect to two teeth simultaneously). In these and other embodiments, the appliance 100 may include two or more arms 130 configured to simultaneously connect to the same tooth.

[0420] Any part of the orthodontic device of this technology may include a biasing portion 150. For example, in some embodiments, its portions (e.g., multiple anchors, multiple arms, multiple biasing portions, multiple attachment portions, multiple links, etc.) may include one or more hyperelastic materials.

[0421] Further details regarding the application of (multiple forces) in a single direction via the bias portion 150 (or more specifically, arm 130) are described in U.S. Patent Publication No. 2017 / 0156823A1, the disclosure of which is incorporated herein by reference in its entirety.

[0422] The orthodontic appliances and / or any parts thereof disclosed herein (e.g., multiple anchors, multiple arms, multiple bias portions, multiple attachment portions, multiple links, etc.) may comprise one or more hyperelastic materials. The orthodontic appliances and / or any parts thereof disclosed herein (e.g., multiple anchors, multiple arms, multiple bias portions, multiple attachment portions, multiple links, etc.) may comprise nitinol, stainless steel, β-titanium, cobalt-chromium, MP35N, 35N LT, one or more metal alloys, one or more polymers, one or more ceramics and / or combinations thereof.

[0423] Figure 2A and Figure 2B This is a front view of an orthodontic appliance 100 mounted on the upper and lower arches of the patient's oral cavity M, wherein arms 130 are connected to fixation members 160 attached to the lingual surfaces of the teeth. It should be understood that one or both of the upper and lower arches of the appliance 100 may be positioned near the buccal side of the patient's teeth, and fixation members 160 and / or arms 130 may optionally be connected to the buccal surfaces of the teeth.

[0424] Figure 2A The teeth in the OTA are shown, with arm 130 in a deformed or loaded state, while Figure 2BA tooth in an FTA is shown, with arm 130 in a substantially unloaded state. When the tooth is in an OTA, as arm 130 is initially fixed to the fixation member 160, arm 130 is forced to take a shape or path different from its "designed" configuration. Due to the inherent memory of the elastic bias portion 150, arm 130 applies continuous corrective forces on the tooth to move the tooth toward the FTA, which is the position of bias portion 150 in its designed or unloaded configuration. Therefore, tooth repositioning using appliances of this technique can be accomplished in a single step using a single appliance. Compared to braces, appliances of this technique not only allow for fewer visits and shorter treatment times but also significantly reduce or eliminate the pain experienced by patients due to tooth movement. With traditional braces, the affected tooth is subjected to significant force each time the orthodontist makes adjustments (e.g., installing a new archwire, bending an existing archwire, repositioning brackets, etc.), which is very painful for the patient. Over time, the applied force diminishes until eventually a new wire is needed. However, the appliances of this technique apply continuous, movement-generating forces to the teeth as they are fitted, allowing the teeth to move at a slower rate, which is much less painful (if painful) for the patient. Although the appliances disclosed herein apply lower and less painful forces to the teeth because the applied forces are continuous and the teeth can move independently (and therefore more effectively), the appliances of this technique reach the FTA faster than conventional braces or aligners, because both of these alternatives (i.e., conventional braces or aligners) require intermediate adjustments.

[0425] In many embodiments, the force generating movement is lower than that applied by conventional braces. In those embodiments where the appliance incorporates a hyperelastic material (e.g., nitinol), the hyperelastic material behaves like a constant-force spring over a certain strain range, so the applied force does not decrease significantly as the teeth move. For example, as... Figure 2C As shown in the stress-strain curves of nickel-titanium and steel, the nickel-titanium curve is relatively flat compared to the steel curve. Therefore, the hyperelastic connectors, offset portions, and / or arms of this technology apply substantially the same stress (e.g., deflection) for many different strain levels. Consequently, the force applied to a given tooth remains constant during treatment as the tooth moves, at least until the tooth is very close to or in its final alignment. The appliance of this technology is configured to apply a force just below the pain threshold, such that the appliance always applies maximum painless force to the tooth during tooth movement. This results in the most efficient (i.e., fastest) tooth movement without pain.

[0426] In some embodiments, tooth repositioning may include multiple steps performed sequentially using multiple orthodontic appliances. Embodiments involving multiple steps (or multiple appliances, or both) may include one or more intermediate dentitions (ITAs) between the original dentition (OTA) and the desired final dentition (FTA). Similarly, the appliances disclosed herein may be designed to be installed after a first or subsequently used appliance has moved a tooth from the OTA to the ITA (or from one ITA to another) and subsequently removed. Therefore, appliances of this technology may be designed to move a tooth from an ITA to an FTA (or to another ITA). Additionally or alternatively, appliances may be designed to move a tooth from an OTA to an ITA, or from an OTA to an FTA, without requiring appliance replacement at the ITA.

[0427] In some embodiments, the orthodontic appliances disclosed herein can be configured such that once installed on a patient's teeth, the appliances cannot be removed by the patient. In some embodiments, the appliances can be removed by the patient.

[0428] Any exemplary orthodontic appliance or appliance portion described herein may be made of any suitable one or more materials, such as, but not limited to, nitinol, stainless steel, β-titanium, cobalt-chromium or other metal alloys, polymers, or ceramics, and may be made into a single, integrally formed structure, or alternatively, into a single structure consisting of multiple separately formed components joined together. However, in certain examples, the rigid bars, bracket connectors, and loops or bending features of the orthodontic appliance (or portion thereof) described in these examples are manufactured according to a process described in more detail below, by cutting a two-dimensional (2D) form of the orthodontic appliance from a 2D sheet of material and bending the 2D form into the desired 3D shape of the orthodontic appliance. Additionally or alternatively, any suitable technique may be used to form such an orthodontic appliance (or portion thereof), including the technique described in U.S. Patent Publication No. 2017 / 0156823A1, which is incorporated herein by reference in its entirety.

[0429] III. Selected manufacturing methods for orthodontic appliances and clamps

[0430] Figure 3A process 300 for designing and manufacturing orthodontic appliances as described elsewhere herein is illustrated. The specific processes described herein are merely exemplary and can be appropriately modified to achieve desired results (e.g., desired forces applied to each tooth by the appliance, desired material properties of the appliance, etc.). In various embodiments, other suitable methods or techniques may be used to manufacture orthodontic appliances. Furthermore, although various aspects of the methods disclosed herein involve sequences 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.

[0431] As described above, in some embodiments, orthodontic appliances are configured to engage with a patient's teeth when they are in their original dentition (OTA). In this position, elements of the appliance apply a customized load on individual teeth to push them toward a desired final dentition alignment (FTA). For example, an arm 130 of appliance 100 may engage with a tooth and be configured to apply force to push the tooth in a desired direction toward the FTA. In one example, the arm 130 of appliance 100 may be configured to apply tension that pushes the tooth lingually along a face-lingual axis. By selecting appropriate dimensions, shapes, shape settings, material properties, and other aspects of the arm 130, a customized load can be applied to each tooth to move each tooth from its OT toward its FTA. In some embodiments, the arms 130 are all configured such that little or no force is applied once the tooth to which the arm 130 is engaged has reached its FTA. In other words, appliance 100 may be configured such that the arm 130 is stationary in the FTA state.

[0432] like Figure 3 As shown, process 300 can begin with obtaining data (e.g., positional data) characterizing the patient's original tooth alignment (OTA). In some embodiments, while the patient's teeth are in their original or pre-treatment state, the operator can obtain a digital representation of the patient's OTA, for example using optical scanning, cone-beam computed tomography (CBCT), patient impression scanning, or other suitable imaging techniques, to obtain positional data of the patient's teeth, gingiva, and optionally other adjacent anatomical structures.

[0433] Process 300 continues at box 304, obtaining data (e.g., positional data) characterizing the patient's expected or desired final tooth alignment (FTA). The data characterizing the FTA may include coordinates (e.g., X, Y, Z coordinates) of each patient's teeth and gingiva. 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 gingiva. In some embodiments, the operator may obtain a digital representation of the patient's FTA, for example, by generating a digital model of the FTA using segmentation software (e.g., iROK Digital Dental Studio) to create individual virtual teeth and gingiva from 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 position on the lingual surface (or other suitable surface) for placing the fixation member 160). With or without the fixation member digital model, suitable software can be used to move the virtual teeth with the attached fixation member 160 from the OTA to the desired final position (e.g., FTA).

[0434] In block 306, a digital model of the heat-treated clamp is available. In some embodiments, the heat-treated clamp digital model may correspond to one or more anatomical digital models (e.g., OTA digital models, FTA digital models, combinations thereof, etc.) and / or be derived from said one or more anatomical digital models. For example, the anatomical digital models may be modified in various ways (e.g., using MeshMixer or other suitable modeling software) to present a model suitable for manufacturing the heat-treated clamp. In some embodiments, multiple anatomical digital models may be combined to form the heat-treated clamp digital model. For example, the gingival portion of the OTA digital model may be combined with the dental portion and / or fixation member portion of the FTA digital model to form the heat-treated clamp digital model. In some embodiments, the anatomical digital model may be modified to replace the fixation member 160 (which is configured to attach to the arm 130 of the appliance 100) with a hook-shaped member (which may be configured to facilitate temporary connection of the heat-treated clamp to the appliance for shape setting). Figure 2A and 2B Additionally or alternatively, the anatomical digital model can be modified to enlarge or thicken the gingiva, remove one or more teeth, and / or add structural components to increase rigidity. In some embodiments, the gingiva can be enlarged or thickened to ensure that portions of the orthodontic appliance (e.g., anchors) manufactured in part based on the anatomical digital model do not engage or contact the patient's gingiva when the appliance is fitted. As a result, modifications to the anatomical digital model as described herein can be accomplished to provide patients with a less painful tooth repositioning experience.

[0435] Process 300 continues at block 308 to obtain a digital model of the orthodontic appliance. As used herein, the terms “digital model” and “model” are intended to refer to a virtual representation of an object or set of objects. For example, the term “digital model of an orthodontic appliance” refers to a virtual representation of the structure and geometry of an orthodontic appliance, including its individual components (e.g., anchors, arms, offset portions, attachment portions, etc.). In some embodiments, a substantially planar digital model of the orthodontic appliance is generated, at least in part, based on a heat-treated clamp digital model (and / or an FTA digital model). According to some examples, a contour or 3D digital model of the orthodontic appliance, generally corresponding to one or more portions of the FTA and / or OTA, can be generated first, conforming to the surface and attachment features of the heat-treated clamp digital model. In some embodiments, the 3D digital model of the orthodontic appliance may include generic arm portions and fixation members, without requiring a specific geometry, dimension, or other characteristic of the arm selected or defined by a particular patient. The 3D digital model of the orthodontic appliance can then be flattened to generate a substantially planar or substantially 2D digital model of the orthodontic appliance. In some embodiments, a particular configuration of the arm 130 can then be selected (e.g., the geometry of the bias portion 150, its position along the anchor 120). Figure 1B (e.g., arms attached to the tooth) to apply the required force to push the corresponding tooth (attached to arm 130) from its OTA to its FTA. As previously described, in some embodiments, the arms are configured to be substantially stationary or in a substantially stress-free state when in the FTA. The selected arm configuration can then be replaced or otherwise incorporated into the planar orthodontic appliance digital model.

[0436] At box 310, a heat treatment fixture can be manufactured. For example, using a digital model of the heat treatment fixture (box 306), the heat treatment fixture can be cast, molded, 3D printed, or otherwise manufactured using a suitable material configured to withstand heating to set the shape of an orthodontic appliance thereon.

[0437] At box 312, an orthodontic appliance can be manufactured. In some embodiments, manufacturing the appliance includes first manufacturing the appliance in a planar configuration based on a digital model of the planar appliance. For example, the planar appliance may be cut from a sheet of metal or other suitable material. In some embodiments, the appliance is cut from a nitinol or other metal sheet using laser cutting, water jetting, stamping, chemical etching, machining, or other suitable techniques. The material of the appliance may be manipulated, for example, by electropolishing, etching, grinding, deposition, or otherwise to achieve desired material properties, and the thickness of the material may vary throughout the appliance.

[0438] According to some examples, planar components (e.g., cut from a metal plate) can be bent or otherwise manipulated into a desired arrangement (e.g., substantially corresponding to one or more portions of the FTA and / or OTA) to form a profile appliance. In some embodiments, the planar appliance can be bent into place by attaching it to a heat-treated clamp manufactured in block 310. For example, the arms of the appliance can be removably attached to hook members of the heat-treated clamp, and optionally, the arms or other portions of the appliance can be secured to the heat-treated clamp using ligatures or other temporary fasteners. The resulting assembly (i.e., the appliance secured to the heat-treated clamp) can then be heated to shape the appliance into its final form. In some embodiments, the final form of the appliance can correspond to or substantially correspond to the FTA and / or OTA. For example, when the appliance is in its final form, the anchor portion of the appliance can substantially correspond to the gingiva from the OTA, while the arms of the appliance substantially correspond to the teeth in the FTA. Thus, the appliance is configured to be in a stress-free or nearly stress-free state in the FTA. During the procedure, the appliance can then be installed in the patient's mouth (e.g., by bending or otherwise manipulating the arms of the appliance to attach to the brackets of the patient's teeth in the OTA). Due to the shape setting of the appliance and the geometry of the arms and anchors, the arms will tend to push each tooth away from its OTA and toward the FTA.

[0439] Additional details and further examples of the processes used for designing and manufacturing orthodontic appliances and heat-treated clamps are described below. The specific processes disclosed herein are exemplary and can be modified as needed to achieve desired results (e.g., the desired force applied to each tooth by the appliance, the desired material properties of the final appliance, etc.). Furthermore, although various aspects of the methods disclosed herein involve sequences 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.

[0440] It can be used Figure 4One or more aspects of the manufacturing system 400 schematically illustrated herein are used to perform several methods disclosed herein. System 400 may include an imaging device 402 communicatively coupled to a computing device 404. Imaging device 402 may include any suitable device or set of devices configured to acquire image data or other digital representations of a patient's teeth, gums, and other dental anatomy. For example, imaging device 402 may include an optical scanning device (e.g., commercially available from ITERO, 3SHAPE, etc.), a cone-beam computed tomography scanner, or any other suitable imaging device. In some embodiments, imaging device 402 may be any suitable device for acquiring a digital representation (e.g., OTA) of a patient's anatomy, even if such digital representation is not based on and does not form a graphical representation of the patient's anatomy.

[0441] Computing device 404 can be any suitable combination of software and hardware. For example, computing device 404 may include a dedicated computer or data processor specifically programmed, configured, or constructed to execute one or more computer-executable instructions as explained in detail herein. Additionally or alternatively, computing device 404 may include a distributed computing environment in which tasks or modules are executed by a remote processing device linked via a communication network (e.g., a wireless communication network, a wired communication network, a cellular communication network, the Internet, a short-range wireless network (e.g., via Bluetooth)). In a distributed computing environment, program modules may reside in both local and remote memory storage devices.

[0442] Computer execution instructions, data structures, and other data according to this technology can be stored or distributed on computer-readable storage media, including magnetically or optically readable computer disks, as microcode on semiconductor memory, nanotechnology memory, organic or optical memory, or other portable and / or non-transitory data storage media. In some embodiments, aspects of this technology can be distributed over a period of time on a propagating signal on a propagation medium (e.g., electromagnetic waves, sound waves) via the Internet or other networks (e.g., Bluetooth networks), or can be provided on any analog or digital network (packet switching, circuit switching, or other schemes).

[0443] System 400 may also include one or more input devices 406 (e.g., touchscreen, keyboard, mouse, microphone, camera, etc.) and one or more output devices 408 (e.g., display, speaker, etc.) connected to computing device 404. In operation, a user can provide instructions to computing device 404 and receive output from computing device 404 via input devices 406 and output devices 408.

[0444] like Figure 4As shown, computing device 404 can be connected to one or more manufacturing systems 410 (including manufacturing machines) for manufacturing orthotics, heat treatment fixtures, and any other components and associated tools, as described herein. Computing device 404 can be connected to manufacturing systems(s)410 via any suitable communication connection (including, but not limited to, direct electronic connection, network connection, etc.). Alternatively or additionally, connectivity can be provided by delivering a physical, non-transient storage medium to manufacturing system 410 on which data from computing device 404 has been stored.

[0445] Methods for designing orthodontic appliances and clamps

[0446] Figure 5 This is a flowchart of process 500 for designing orthodontic appliances. Process 500 begins at box 502, obtaining data characterizing the original tooth alignment (OTA). For example, as... Figure 6 As shown, OTA data can be obtained by scanning a 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 3D model of each tooth. Any suitable technology can be used to perform the scan, such as a dental cone-beam CT scanner, magnetic resonance imaging (MRI), or similar devices or techniques. In various examples, OTA data may include data associated with the tooth roots and exposed portions, which can be advantageous in designing appropriate orthodontic appliances. In some examples, OTA data can be obtained using impressions made from the patient's maxilla and mandible (e.g., using polyvinylsiloxane or any other suitable impression material). The impressions can then be scanned to create 3D data, which may include the relationship between the maxilla and mandible (e.g., recording the patient's occlusion). In examples using impressions, the relationship between teeth in the upper and lower dental arches (interarch relationship) can be obtained by the patient taking a wax bite in a central position. In various embodiments, OTA data can be obtained directly (e.g., by imaging the patient's oral cavity using appropriate imaging equipment) or indirectly (e.g., by receiving pre-existing OTA data from an operator or another source).

[0447] return Figure 5 Process 500 continues to obtain the OTA digital model at box 504. Figure 7 This is a graphical representation of an example of the OTA digital model 700. The digital model 700 can virtually represent or characterize the arrangement of a patient's teeth and gums in the original tooth alignment. For example... Figure 7 As shown, the teeth in an OTA may be maloccluded, misaligned, crowded, or require orthodontic treatment. In some embodiments, one or more teeth present in an OTA may be designated for extraction before the use of orthodontic appliances.

[0448] In some embodiments, obtaining an OTA digital model corresponding to the OTA data may include first obtaining a single, complex 3D database of the patient's jaw, then segmenting it to separate the patient's teeth into individual 3D volumes (e.g., a single tooth or blocks of teeth), which can then be virtually manipulated by an operator. This segmentation can be performed using any suitable technology or software, such as the iROK Digital Dentistry Studio or other suitable software. After segmentation, the resulting 3D database of the upper and lower teeth may include models of the gingiva and individual models of each tooth. As a result, the OTA data can be manipulated by an operator to virtually move the teeth relative to the gingiva. Teeth can be manipulated from the OTA toward final tooth alignment (FTA), as described in more detail elsewhere herein. Figure 8 An exemplary final tooth alignment (FTA) is shown. Figure 8 As shown, compared to OTA (e.g., as reflected in digital model 700), teeth in FTA can be more aligned, have less malocclusion, and are improved aesthetically and functionally. In some embodiments, such as based on an operator's prescription, FTA can have desired or favorable inter- and intra-arch alignments. For example, one or more (or all) teeth of the maxilla or mandible (or both) are moved until their cusps have good interdental interlocking and occlusion.

[0449] Return to reference Figure 5 Process 500 continues in block 506 to obtain digital models of (multiple) fixation members. As previously described, fixation members (e.g., fixation member 160, brackets, etc.) can be attached to a patient's teeth to allow an orthodontic appliance (e.g., appliance 10) to engage with them. The digital model of the fixation member may include a virtual representation of the geometry and / or other structural features of (multiple) fixation members. In various embodiments, the digital model of the fixation member may be the same for each fixation member, or it may vary between fixation members. For example, different fixation members may be used for molars and incisors. Figure 9 An exemplary digital model 900 of a fixed component is shown.

[0450] Continue to refer to Figure 5 Process 500 continues in block 508 to obtain an OTA digital model with attached fixing components. For example, fixing component digital model 900 ( Figure 9 It can be applied to OTA digital model 700 ( Figure 7 The appropriate position of the patient's teeth within the range. The resulting digital model 1000 is shown in... Figure 10In this embodiment, multiple digital models of fixation members 900 are arranged along the lingual surface of the patient's teeth. In some embodiments, in the digital model 1000, each patient tooth may have a fixation member attached thereto. As previously described, the orthodontic appliance may include multiple arms having attachment portions configured to be attached to fixation members (e.g., brackets) that are attached to the patient's teeth.

[0451] In some examples, a digital model 900 of a fixation member can be virtually positioned on a tooth in an OTA using appropriate software (e.g., iROK Digital Dental Studio). In some embodiments, virtual positioning of a fixation member may include selecting a virtual model of a specific fixation member from a library of available fixation members and then positioning the selected fixation member on one or more teeth. In some embodiments, fixation member positioning may be assigned automatically (e.g., by automatically positioning the bracket in the center or a predetermined portion of the tooth) or manually (e.g., by the operator selecting and / or manipulating the attachment position of each fixation member). In some embodiments, the position of each fixation member may be adjusted by the operator as needed. For example, it may be desirable to position the fixation member as close to the gum line as possible to avoid interference with fixation members on another jaw or with teeth from another jaw when the mouth is closed.

[0452] In some embodiments, a digital model 1000 having teeth in an OTA and fixation 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 fixation members to the patient's teeth. For example, similar to an orthodontic appliance, the bonding tray can be configured to be mounted on the patient's teeth and may include recesses on one side of each tooth, the recesses being sized and constructed to receive appropriate fixation members (e.g., brackets) therein. In various embodiments, such recesses can be located on any suitable surface of the lingual, buccal, mesial / distal, occlusal, root, or tooth to which the corresponding bracket is to be bonded. In operation, appropriate fixation members can be placed in each recess, and then an adhesive (e.g., an adhesive that cures when exposed to ultraviolet light) can be applied to the engagement surface of each fixation member. The tray can then be placed on the patient's teeth, and the adhesive can be cured to bond all fixation members to their appropriate positions on each tooth.

[0453] To generate such a bonding tray, a digital model 1000 can be used, which characterizes the tooth with the fixation member attached in the OTA. The digital model 1000 can be further manipulated, for example, to remove excess virtual gingiva, thereby limiting the size of the tray to only the dimensions required to hold the fixation member in place against the patient's tooth. The refined digital model can then be used, for example, using 3D polymer resin printing or other suitable techniques, to generate a physical 3D model of the patient's tooth, on which the fixation member is disposed.

[0454] In some embodiments, a suitable material (e.g., a transparent polymer resin) can then be formed (e.g., thermoformed) on a physical model of the patient's teeth with fixation members in the OTA. This can form an orthodontic tray with grooves shaped and constructed to receive the fixation members therein. The fixation members can then be placed into the corresponding grooves 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.

[0455] In some embodiments, the bonding tray can be directly 3D printed without requiring a physical model of the patient's teeth and without using thermoforming. For example, a digital model of the bonding tray can be derived from a digital model 1000 of teeth in an OTA characterizing the attached fixation member. In some embodiments, a film of the digital model 1000 can be generated and can be trimmed to provide a general tray-like structure having surfaces corresponding to the teeth and fixation member in the digital model 1000. The formed model can be manipulated to provide features for retaining the bracket in the corresponding recesses. Finally, the bonding tray can be 3D printed based on the digital model, for example using a 3D-printable polymer resin or other suitable materials or deposition techniques.

[0456] Alternatively, the operator can attach the fixation device directly to the patient's teeth without the aid of a tray.

[0457] Return to reference Figure 5 Process 500 continues in block 510, resulting in an FTA digital model 1100 with attached fixing member 900. Figure 11 For example, the digital model of teeth in OTA 1000 ( Figure 10 The model of ) and the fixed component 900 attached thereto 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.

[0458] The FTA digital model 1100 can be derived, at least in part, from data characterizing the teeth in the FTA. Such FTA data can include a digital representation of the patient's teeth's desired final position and orientation relative to each other and relative to the gingiva. The FTA data can be obtained directly (e.g., generated by the operator) or can be received from an external source (e.g., the FTA data can be generated by a third party and provided to the operator to design an appropriate orthodontic appliance).

[0459] In some embodiments, FTA data can be obtained by manipulating OTA data to virtually move the patient's teeth. An operator can use suitable software (e.g., iROK Digital Dental 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 gingiva relative to the OTA to maintain the natural appearance of the gingiva and to more accurately reflect the orientation and position of the gingiva when the teeth are in FTA. This movement of the gingiva can be achieved using gingival deformation or other suitable techniques.

[0460] In some embodiments, the FTA can reflect changes in a patient's teeth that may occur as part of a treatment procedure. For example, as part of treatment, the operator may extract one or more teeth from the patient due to insufficient space for all teeth to fit into the dental arch (or for other reasons). In this case, the extracted teeth can be excluded from the FTA data. If the operator determines that a tooth needs to be reduced in size due to insufficient space, interproximal reduction (IPR) can be performed on the patient. In this case, tooth stripping and size reduction from the FTA can be performed to match the IPR performed by the operator.

[0461] In some embodiments, the proposed FTA may be developed by the operator (e.g., independently or entirely or partially based on input from the treating orthodontist) and then sent to the treating orthodontist for review and comment. If the treating orthodontist has comments, she may provide the operator with input that can be transmitted electronically or otherwise (e.g., written records, suggested manipulation of one or more teeth or fixation components, etc.). The operator may then revise the FTA and send the revised proposed FTA back to the treating orthodontist for further review and comment. This iterative process may be repeated until the treating orthodontist approves the proposed FTA and the resulting digital model 1100.

[0462] Additionally or alternatively, the FTA digital model (e.g., such as...) Figure 8 (As shown) can be manipulated to attach the digital model of the fixing member 900 to the tooth in the appropriate position. In some embodiments, it can be taken from the digital model 1000 ( Figure 10The relative position of each fixation member with respect to its corresponding tooth is obtained or derived, wherein the fixation member is attached to a tooth in the OTA. In some embodiments, the fixation member may first be positioned on the tooth in the FTA to generate a digital model 1100. Figure 11 ), and this model can then be used to generate digital model 1000 ( Figure 10 For example, by manipulating the digital model 1100 to move the teeth to the OTA.

[0463] Return to reference Figure 5 Process 500 continues at block 512, determining the displacement of individual teeth or groups of teeth between the OTA and FTA. For example, the displacement of each tooth between the 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 along the mesiodistal, buccolingual, and / or occlusal gingival directions, and rotation in the form of buccolingual root torque, mesiodistal angulation, and mesial out-in 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 can be performed for each tooth in each jaw to generate a dataset including the desired displacement of each tooth along the six degrees of freedom.

[0464] Process 500 continues in block 514 to obtain a digital model of the heat treatment fixture. Figure 12 An exemplary fixture digital model 1200 is shown, which can be manipulated via an OTA-controlled digital model 700. Figure 7 ), FTA's digital model 800 ( Figure 8 ), OTA digital model 1000 with attached fixed components ( Figure 10 ) and / or a digital model 1100 of an FTA with attached fixing components. Figure 11 This can be generated using various methods. For example, multiple digital models 700, 800, 1000, and 1100 can be manipulated to generate a digital representation of a fixture (e.g., a heat-treated fixture) for manufacturing orthodontic appliances. The multiple digital models 700, 800, 1000, and 1100 can be operated in various ways to generate suitable fixture data. In some embodiments, suitable software (e.g., […]) can be used. MeshMixer can be used to perform this operation.

[0465] In some examples, the fixation members in (multiple) digital models 1000, 1100 can be modified or replaced with appropriate fixation portions 1202, each configured to engage with an arm of the orthodontic appliance and facilitate temporary fastening of the appliance to a clamp. Additionally or alternatively, fixation portions 1202 can be added to digital models 700, 800. For example, a bracket-like fixation member can be replaced with fixation portion 1202, which includes a vertical channel 1206 and a horizontal channel 1204 configured to mate with an attachment portion 140 of the orthodontic appliance 100. Multiple protrusions 1208 can be provided along one or more side surfaces of fixation portion 1202. Channels 1204 and 1206, together with protrusions 1208, can provide a structure configured to receive ligatures or other fasteners passing through them. For example, an operator can attach the orthodontic appliance 100 to a clamp and then wind ligature wire through the horizontal channel 1204 and within the space between adjacent protrusions 1208 to hold the orthodontic appliance 100 in proper position against the clamp. Additionally or alternatively, the horizontal channel 1204 may be configured to mate with an attachment portion 140 of the orthodontic appliance 100, for example, deep enough (e.g., deeper than the corresponding channel of the fixation member 900 of the (plural) digital models 1000, 1100) to receive the attachment portion 140 therein and to receive ligature wires or other fasteners passing therethrough. In some embodiments, a vertical channel 1206 may be configured to mate with a portion of the attachment portion 140 of the orthodontic appliance 100 such that a single attachment portion 140 may be partially received within the horizontal channel 1204 and partially received within the vertical channel 1206. The protrusions 1208 may additionally define grooves or recesses configured to receive ligature wires or other elongated fasteners. The clamp model 1200 may also define through channels or holes within each fixing portion 1202. These through channels may allow a pushing tool to be inserted from the back of the fixing portion 1202 (e.g., through the cheek of the clamp model 1200) to push the attachment portion 40 away from the fixing portion 1202 after heat treatment is completed and the ligature wire or other fasteners are removed.

[0466] Additionally or alternatively, the digital models(s) 700, 800, 1000, 1100 can be manipulated to alter the shape or configuration of the gingiva, thereby generating a clamp model 1200. When the appliance is fitted, the patient may experience considerable discomfort if any part of the appliance impacts the gingiva. Therefore, it may be necessary to design an appliance that sits near the patient's gingiva without impacting it. In some embodiments, this can be achieved by enlarging the gingiva in the digital models(s) 700, 800, 1000, 1100 to generate the clamp model 1200. For example, the lingual surface of the gingiva in (multiple) digital models 700, 800, 1000, and 1100 can be extended (e.g., moved further 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). Thus, when an orthodontic appliance is generated using the surface data of the fixture (e.g., appliance 100 can be shaped to substantially correspond to a portion of the lingual surface of fixture model 1200, as described in more detail below), the size and construction of the appliance can be designed to be placed a short distance away from the patient's gingiva without impacting the patient's gingiva.

[0467] Referring again to box 514, multiple digital models 700, 800 without attached fixation members and / or multiple digital models 1000, 1100 with attached fixation members can be manipulated to remove unwanted teeth or other structural elements from the heat-treated orthodontic appliance and / or add structural features to enhance the clamp during heat treatment to achieve sufficient rigidity. For example, as Figure 12 As shown, the fixture model 1200 does not include any teeth, but retains at least a portion of the gingival surface 1210. Furthermore, the fixture model 1200 includes a stabilizing crossbar 1212, which enhances the rigidity of the resulting fixture. Various other modifications can be made to the (multiple) digital models 700, 800, 1000, and 1100 to achieve the desired heat-treated fixture model 1200.

[0468] Return to reference Figure 5 Process 500 continues at box 516 to obtain the digital model of the orthodontic appliance template. Figure 13 An example of the digital model 1300 of the orthodontic template is shown here in a configuration that matches the fixture model 1200.

[0469] Model 1300 defines the anchor portion 1302, the arm portion 1304, and the attachment rod portion 1306. These components can take the form of a generalized template for an orthodontic appliance, which can then be customized for a specific patient (as described below). Figure 15 (Described in more detail). For example, anchor portion 1302 may correspond to anchor 120 of the completed orthodontic appliance, and arm portion 1304 may serve as a placeholder for the arm 130 of the completed orthodontic appliance. Attachment bar portion 1306 takes the form of a continuous strip connecting each arm 130. (As described in more detail...) Figure 13 As shown, the arm portion 1306 can be configured to be received within the channel 1204 of the fixing portion 1202 of the clamp model 1200. The attachment rod portion 1306 can partially correspond to a portion of the attachment portion 140 of the completed orthodontic arm 130.

[0470] In various embodiments, surface data of the jig model 1200 can be used to generate the orthodontic appliance template digital model 1300. For example, the orthodontic appliance template digital model 1300 can be configured to substantially correspond to the surface of the jig model 1200, such that the anchor portion 1302 corresponds to the contour of the jig model 1200 derived from data characterizing the patient's gingiva. As previously mentioned, the treatment jig model 1200 can be modified relative to the OTA model 1100, particularly by enlarging the gingiva, etc. Thus, when the anchor portion 1302 contacts the gingival portion of the jig model 1200, the anchor portion 1302 can be positioned slightly spaced from the actual gingiva, as characterized in the OTA model 700. In some embodiments, the orthodontic appliance template model 1300 may not have a thickness dimension, but instead correspond to a three-dimensional surface following the contour of the jig model 1200. In some embodiments, the orthodontic appliance template model 1300 may have at least some thickness.

[0471] Within box 518, the orthodontic template digital model 1300 can be flattened or otherwise manipulated to generate a planar orthodontic 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 contour orthodontic appliance template model 1300. For example, the digital model 1300 can be generated by flattening, planarizing, or otherwise transforming the digital model 1300 to produce the planar orthodontic appliance template model 1400. Figure 13 Convert to a planar orthodontic appliance template (template model 1400) Figure 14 This conversion can be performed using a processor system and appropriate software, such as, but not limited to, [other methods]. Inventor Or other suitable software.

[0472] In box 520, obtain the digital model of the planar orthodontic appliance. Figure 15 An example of a planar orthodontic appliance model 1500 is shown. In this stage, the planar template model 1400 can be modified or replaced, for example. Figure 14 The specific shape and configuration of the arms of an orthodontic appliance are determined by selecting certain parts or components. For example, specific dimensions, geometry, and material properties of the arms can be selected to apply the necessary forces and / or torques to achieve the desired displacement determined at block 512. In some embodiments, a pre-filled 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 arm designs in the pre-filled library to determine the spring force that such an arm will exert when deflected by a specific amount (e.g., the amount of deflection between FTA (when the arm is stationary) and OTA). In some embodiments, the operator can review and / or modify the fully or partially automated selection of a particular arm design based on relevant criteria. For example, if the suggested arm design includes overlapping or otherwise interfering arms, the operator can manually adjust the shape and / or configuration of the arms.

[0473] Based on the determined displacement, the force and / or torque required to move each tooth from the OTA to the FTA can be determined. The force required to move the tooth is typically in the centi-Newton range, and the distance moved is typically in the millimeter range. The torque (Newton-millimeter) used to rotate the tooth can be calculated by multiplying the magnitude of the applied force by the lever arm. Typically, the displacement can be a 3D tooth motion that combines translational and rotational movements.

[0474] The force and / or torque required to achieve FTA may depend on the patient's anatomy, such as the size of the specific tooth to be moved, the anatomy of the tooth root, etc. Force and / or torque may also depend on other physiological parameters (e.g., bone mineral density, biological determinants, sex, race, jaw (maxilla or mandible), the mechanical properties of the surrounding tissues (lips, tongue, gums, and bone) around the movable tooth, etc.). The specific force and / or torque applied to a given tooth will also depend on the specific positioning of the fixation member (e.g., bracket). For example, a fixation member positioned away from the center of resistance of the tooth will generate a greater torque under a given force than a fixation member positioned closer to the center of resistance of the tooth. Based on the desired displacement (e.g., along six degrees of freedom), the patient's anatomy, and the position of the fixation member, a specific arm configuration can be selected to generate the desired force and / or torque on the target tooth, thereby moving the tooth from OTA to FTA. By determining the appropriate thickness, width, shape, and configuration of the arms and other components of the orthodontic appliance, an appliance configuration for applying force and torque to the appropriate tooth to move it to FTA is determined.

[0475] In specific examples, the design of the orthodontic appliance can be performed by an operator using a processor system and appropriate design software (e.g., but not limited to CAD software, etc.). Inventor (etc.) to perform the operation. FEA software (such as, but not limited to, Abaqus, Ansys, etc.) can be used to design springs and arms to apply desired or optimal forces to teeth. For example, such software and processing systems can be used to design and vary the thickness, cut width, length, and overall design of each arm, at least in part, based on the movement of the teeth to which the arms are connected.

[0476] In some examples, if the tooth needs to be moved a longer distance or the tooth is small (e.g., a lower incisor), 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 variations in the rate of tooth movement based on direction. It is known that when a given force is applied to a tooth, the rate of tooth movement varies depending on the direction of movement. For example, for a given force, squeezing is the fastest movement, intrusion is the slowest, and mesiodistal and buccolingual movements lie between these two extremes. In one example, if a tooth moves 2 mm occlusally and 1 mm distally per month under the same force, 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 distally from there until the movement is complete. It may be desirable for the tooth to move along a specific trajectory, so the force applied distally can 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 trajectory from OTA to FTA.

[0477] In some embodiments, due to periodontal problems such as bone resorption, root resorption, or attachment loss, the arm 130 can be designed to apply smaller forces 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 conventional orthodontics. In a particular example, the computer-aided program employs algorithms to select or configure the arm or other features of the appliance, for example, from a set or more predefined options or a range of options. Thus, for example, a set or series of options can be predefined for one or more parameters associated with the arm or other feature.

[0478] One or more parameters associated with arm 130 may include, but are not limited to, the total length of the arm, the shape or configuration of the offset portion 150, the shape or configuration of the attachment portion 140, the width dimension of one or more portions of arm 130, the thickness dimension of one or more portions of arm 130, etc.

[0479] Obtaining the digital model 1500 of the planar orthodontic appliance may also include determining the shape and configuration of the anchors 120. For example, the anchors 120 may be selected to substantially conform to the patient's gums without impacting them. The thickness, depth, or other characteristics of the anchors 120 may also be selected to provide sufficient rigidity to resist forces generated by the arm. In some embodiments, the design of the anchors 120 may be automatically generated (e.g., by automatically generating to substantially conform to the patient's gums or other locations in an FTA model (e.g., model 1100) or an OTA model (e.g., model 700 or 1000). In some embodiments, the operator may manually select or modify the design and configuration of the anchors as needed.

[0480] Although in the illustrated embodiment, specific features of arm 130 are selected when the appliance model is in a basic planar or 2D form, in other embodiments, appliance features can be selected and configured based on a digital model whose outline corresponds to the patient's anatomy. For example, the 3D appliance template model 1300 can be modified ( Figure 13 This allows for the selection of specific arms 130, anchors 120, or any aspect thereof to achieve the desired orthodontic appliance. In some embodiments, the template is completely omitted, and a custom orthodontic appliance model is generated based on the OTA model and / or FTA model without using an intermediate template model.

[0481] In some embodiments, the planar appliance model 1500 may be 2D, such that the model does not define the thickness of the appliance. For example, such a model may be used to cut the appliance from a single sheet of material. In this case, the thickness can be determined by selecting the sheet of material and by using techniques such as polishing, etching, grinding, deposition, or other methods to modify the final thickness of the appliance. In some embodiments, the planar appliance model 1500 may define a thickness dimension while remaining substantially planar or flat. For example, the planar appliance model 1500 may define the thickness of the appliance, which may be uniform or may vary across some or all of the anchors 120 and arms 130.

[0482] In some embodiments, a 3D or contoured orthodontic 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 may correspond to an appliance installed in the teeth in the OTA (e.g., using the OTA model 1000). Figure 10 The position data of the fixed component 900 in the model 1500 is used to manipulate the planar orthodontic appliance model 1500, or by using the FTA model 1100. Figure 11 The position data of the fixed component 900 in the model is used to manipulate the planar orthodontic appliance model 1500.

[0483] Referring together to boxes 516, 518, and 520, in some examples, computer-aided programs can be used to select or determine the shape and configuration of the arms, anchors, and / or any other features of an orthodontic appliance. The process can be configured to select one (or more) arm, fixation member, anchor, or its parameters, or any other aspect of the appliance, based on one or more input data. For example, 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 loops or curved features to provide greater force compared to smaller teeth (e.g., incisors). Additionally or alternatively, input data may include the dimensions of the periodontal ligament (PDL) of one or more teeth. The dimensions of the PDL can be obtained through any suitable process, including but not limited to CBCT scans or other imaging techniques. Other input data may include, but is not limited to, the amount or direction of forces applied to one or more teeth in three-dimensional space. For example, the desired direction of tooth movement may require one or more arms of different shapes or configurations than those required for different directions of tooth movement. Other input data may include, but is not limited to, the amount or direction of rotational force (or torque) applied to one or more teeth. For example, the desired tooth movement in the rotational direction may require one or more arms of different shapes or configurations than those required for different tooth movement directions. Furthermore, in some embodiments, two or more arms may be connected to a single tooth, or each arm may be coupled to a separate fixation member, or two arms may be connected to the same fixation member. In this case, the input data may include multiple arms and / or fixation members coupled to each tooth, or alternatively, the number of arms and / or fixation members may be generated as output data.

[0484] In some embodiments, the computer-aided program may include an algorithm that includes (but is not limited to) one or more of the following values ​​as input, representing one or more of the following: (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 region of one or each tooth; (c) the patient's bone mineral density; (d) biological determinants, for example, obtained from saliva, gingival fluid (GCF), blood, urine, mucous membranes, or other sources; (e) the patient's sex; (f) the patient's ethnicity; (g) the jaw (maxilla or mandible) on which the appliance is mounted; (i) the number of teeth on which the appliance is mounted; and (j) the mechanical properties of the tissues (lips, tongue, gums) and bones surrounding the teeth to be moved. In various embodiments, one or more such inputs may influence the force (e.g., magnitude, direction, point of contact) required to move each tooth from the OTA to the FTA or toward the FTA.

[0485] In other examples, other suitable input data may be used. The computer-aided program uses a computer programmed or configured with suitable non-transient software, hardware, firmware, or a combination thereof to generate an output (e.g., one or more selected arm configurations, anchor configurations, or fixing member configurations) based on one or more input data.

[0486] The output generated by the computer-aided 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) the thickness dimension of any part or the entire orthodontic appliance; (d) the mechanical properties of such arms, including but not limited to the magnitude of flexibility, bias force, or elasticity; (e) the design of the anchors; (f) the width or thickness of the anchors; (g) the connection location between the arms and anchors; and / or (h) the transition temperature of nitinol (or other materials) in one or more (or each) parts of the orthodontic appliance. As previously described, in some embodiments, the output may include a specific configuration selected from a pre-filled library of anchors and / or arms. For example, based on the input, the desired force (e.g., magnitude and direction) can be determined for each tooth. Based on the desired force, a suitable anchor member and / or arm configuration that provides the desired force or a suitable approximation thereof can be selected. In some embodiments, the configuration of the orthodontic appliance (including any of the outputs listed above) can be generated independently of any pre-filled library. In some embodiments, generating output may include using finite element analysis (FEA) or other techniques to analyze temporary selections or designs to determine performance parameters, such as the spring force that the arms will exert when these arms deflect a specific amount (e.g., the amount of deflection between the FTA (when the arms are stationary) and the OTA).

[0487] In certain examples, computer-aided processes can be used to create custom-made appliances for each given patient. In other examples, appliances can be manufactured based on a population group in multiple predefined sizes, shapes, configurations, etc. Thus, different semi-custom sizes, shapes, or configurations will be configured to fit each different selected portion of the population. In this way, a more limited number of different appliance sizes, shapes, and configurations can be manufactured to accommodate a relatively large portion of the population.

[0488] Based on the determined shape and configuration of the arms and anchors, complete orthodontic shape data can be generated. In some embodiments, the orthodontic shape data may take the form of 3D data (e.g., an orthodontic in its final form after heat treatment or other suitable setting techniques) or planar or substantially 2D data (e.g., an orthodontic in its tiled form, such as when cut from a sheet of material).

[0489] In box 522, an orthodontic appliance can be manufactured (e.g., based on digital model 1500 of a planar orthodontic appliance (box 520)). And in box 524, a heat-treated fixture can be manufactured (e.g., based on digital model 1200 of a heat-treated fixture (box 514)). The manufacture of the heat-treated fixture and the orthodontic appliance will be described in more detail below.

[0490] In some embodiments, generating complete orthodontic appliance shape data may include obtaining a heat-treated fixture model (e.g., as described below). Figure 12 (As described), and a preliminary orthodontic appliance model is generated based on a heat-treated fixture model. For example, the preliminary orthodontic appliance model may conform to at least a portion of the lingual surface of the heat-treated fixture model. The preliminary orthodontic appliance model can then be modified to include defined arms and anchors, to have defined thickness profiles, etc. The modified orthodontic appliance model can then be flattened for manufacturing as described below.

[0491] Manufacturing method of orthodontic appliances

[0492] As described above, one or more digital models (e.g., a planar orthodontic digital model 1500 or a contour orthodontic digital model) can be generated to characterize or define the orthodontic appliance. In various embodiments, one or more such digital models can be used to manufacture orthodontic appliances for patient use. Figure 16 An example of an orthodontic appliance 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 understand that any suitable manufacturing process can be used to manufacture the orthodontic appliance (or components thereof) disclosed herein.

[0493] In some embodiments, orthodontic appliance 100 may be manufactured using a planar digital appliance model (e.g., planar digital appliance model 1500). For example, the planar digital appliance model may include planar or substantially 2D shape data. The planar shape data may be provided to suitable manufacturing equipment (e.g., but not limited to one or more machines performing cutting, laser cutting, milling, chemical etching, wire electrical discharge machining (EDM), water jetting, punching (stamping), etc.) for cutting planar sheet material into components having a shape corresponding to the planar digital appliance model 1500. The component may be cut from a flat sheet of any suitable material, such as, but not limited to, nitinol, stainless steel, cobalt-chromium alloys, or another type of metal, polymer, hyperelastic material, etc. The thickness of the sheet material may be selected to achieve the desired material properties of the formed component. In various embodiments, the thickness of the sheet material may be uniform or variable (e.g., thinning in specific areas along a gradient using etching, grinding, etc., or thickening in specific areas using deposition, etc.). In some examples, the sheet may have a thickness of about 0.1 mm to about 1.0 mm, about 0.2 mm to about 0.9 mm, about 0.3 mm to about 0.8 mm, about 0.4 mm to about 0.7 mm, or about 0.5 mm. In some embodiments, the sheet may have 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.

[0494] Next, the cut components can be bent from their essentially planar form into a contour arrangement. Figure 16 An example of a completed orthodontic appliance 100 resulting from this curvature of the planar member is shown. As illustrated, and as described elsewhere herein, the appliance 100 may include an anchor 120 and a plurality of arms 130 extending away from the anchor 120. Each arm 130 may include an attachment portion 40 and a bias portion 150 configured to engage with a fixation member adhered to the patient's teeth, the bias portion being disposed between the attachment portion 40 and the anchor 120. When the appliance 100 is installed in the patient's mouth, each arm 130 may engage with different teeth to be moved and apply specific forces to their respective teeth, thereby allowing the operator to move each tooth independently.

[0495] In some embodiments, after being cut from sheet or otherwise formed, the planar member can be bent or otherwise manipulated into a shape or profile corresponding to or substantially corresponding to the FTA configuration. For example, the member may be cut from a flat plate of nitinol or other suitable material and present a generally planar configuration. The member can be bent into a desired 3D or profile configuration, such as corresponding to the profile orthodontic digital model 1600. In some examples, one or more jigs are configured to bend the planar member into a desired 3D shape. In such examples, after cutting the planar member, the planar member can be secured to or between one or more jigs and bent or otherwise manipulated to form a desired 3D shape. In some embodiments, the thickness of the member can be modified in at least some portions to achieve desired material properties before or after cutting the member from sheet. For example, the thickness of the member can be reduced in at least some areas using grinding, chemical etching, photolithography, electrical discharge machining, or any other suitable material removal process. The thickness of the member can be increased in at least some areas using thin film deposition, electroplating, or any other suitable additive manufacturing technique. In some embodiments, planar components can be formed using 3D printing or other techniques, in addition to cutting them from sheet material. 3D printing can offer certain advantages, such as ease of control over the thickness of different portions of the orthodontic appliance. In some embodiments, planar components can be formed by 3D printing metal, polymers, or any other suitable material that can be additively manufactured using 3D printing.

[0496] In some embodiments, the orthodontic appliance shape can be set to a desired profile or 3D configuration (e.g., corresponding to OTA, FTA, heat-treated fixtures, etc.). During or after bending operations, one or more shape-setting procedures (e.g., but not limited to heat treatment) can be applied to the orthodontic appliance while maintaining the desired 3D shape to set the desired three-dimensional shape. Shape-setting procedures involving heat treatment may include rapid cooling of the component after heating during or after bending. Further details regarding example heat treatments and related fixtures are described below.

[0497] By using pre-cut planar components instead of traditional single-diameter wires, a wider variety of final 3D shapes can be created compared to those produced by bending single-diameter wires. The pre-cut planar components can have designed or varying widths and lengths, which, when bent into the desired shape, can result in varying thickness, width, and length dimensions for parts of the 3D orthodontic appliance. In this way, planar components can be cut to provide the desired thickness, width, and length for the offset portion, arm, or other components of the orthodontic appliance. Bending custom-cut planar components allows for a greater variety of shapes compared to bending single-diameter wires.

[0498] In some examples, the entire orthodontic appliance (including arms and anchors) is manufactured by bending a cut planar component into a desired 3D shape. In other examples, for instance, additional components can be attached to the 3D shape after bending. Such additional components may include, but are not limited to, attachment portion 40, offset portion 150, arm 130, etc. Such additional components can be attached to the 3D shape component using any suitable attachment mechanism, including but not limited to adhesive materials, welding, friction fit, etc.

[0499] In some embodiments, the orthodontic appliance can be directly 3D printed into the desired contour or 3D shape configuration. In some embodiments, the 3D-formed components can be 3D printed, for example, using any suitable material. In the case of using nitinol 3D-printed orthodontic appliances, a shape setting process (e.g., heat treatment) may not be required. Furthermore, 3D printing can allow the use of different geometries (e.g., the cross-sectional shape of the anchor component can be elliptical instead of rectangular, which can increase patient comfort on both the gingival and lingual sides of the anchor).

[0500] Orthodontic appliance shape setting method

[0501] As previously described, in some embodiments, the heat treatment fixture model (e.g., heat treatment fixture model 1200) Figure 12 This can be used to generate digital models of orthodontic appliances. For example, a planar orthodontic digital model 1500 can be obtained, at least in part, based on the heat-treated jig model 1200. The heat-treated jig model 1200 can also be used to manufacture heat-treated jigs, which are then used to shape the orthodontic appliance (e.g., planar components cut from a sheet of material can be formed into a desired 3D shape using the heat-treated jig).

[0502] Figure 17 An example of a heat treatment fixture 1700 is shown. Fixture 1700 may be based on a digital model of a heat treatment fixture (e.g., fixture digital model 1200). Figure 12 This can be done by manufacturing a fixture. For example, a digital model or related data can be provided to a manufacturing system to generate a physical model based on the fixture model. In one example, fixture data can be used to 3D print a wax fixture model. The fixture can then be investment-cast in brass or other suitable materials using the wax model. In some embodiments, the fixture can be 3D printed directly from brass or other suitable materials (e.g., stainless steel, bronze, ceramic, or other materials resistant to the high temperatures required for heat treatment). Figure 17 As shown, the clamp 1700 may include a fixing portion 1702 configured to engage with the attachment portion 40 of the orthodontic appliance 100.

[0503] In some embodiments, the manufactured clamps can be used for heat setting of the orthodontic appliance. For example, such as Figure 18As shown, the assembly 1800 may include an orthodontic appliance 100 that has been bent or otherwise manipulated into shape to abut against the surface of a heat-treated clamp 1700. The appliance 100 can be coupled to the clamp 1700 by placing the attachment portion of the arm into the retaining portion 1702 of the clamp. A ligature wire 1802 or other suitable fastener may be wound around the appliance 100 at multiple locations to secure the appliance 100 relative to the clamp 1700. Heat may then be applied to heat-set the appliance 100, after which the appliance 100 can be removed from the clamp 1700.

[0504] An example of a heat treatment procedure may include heating the orthodontic appliance 100 to a selected temperature (e.g., but not limited to 525 degrees Celsius) for a selected time period (e.g., but not limited to 20 minutes) followed by rapid cooling. Rapid cooling can be achieved by any suitable cooling procedure, such as, but not limited to, water quenching or air cooling. In other examples, the heat treatment time and temperature may differ from those discussed above, for example, based on a specific treatment plan. For example, the heat treatment temperature may range from 200 degrees Celsius to 700 degrees Celsius, and the heat treatment time may be up to about 120 minutes. In certain examples, the heat treatment procedure may be carried out in an air or vacuum furnace, a salt bath, a fluidized bed, or other suitable system. After the heat treatment is completed, the orthodontic appliance 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, resistance heating or heating by flowing an electric current through the metal of the orthodontic appliance structure.

[0505] One or more additional post-processing operations can be provided on 3D molded articles, including but not limited to abrasive blasting, shot peening, polishing, chemical etching, electropolishing, electroplating, coating, ultrasonic cleaning, disinfection or other cleaning or decontamination procedures.

[0506] In examples where the orthodontic appliance is made of multiple parts, some (or each) of the parts may be made according to the methods described above and then joined together to form the desired 3D orthodontic appliance configuration. In these or other examples, the orthodontic appliance (or some or each of its parts) may be manufactured by other suitable methods, including but not limited to: direct metal printing, first printing a wax component and then casting the wax component into metal or other materials, printing an elastic material or other polymer, cutting or machining a solid material, or cutting parts from a sheet of metal and shaping them into the desired 3D configuration.

[0507] As discussed herein, one or more heat-treated jigs can be configured to bend cut planar members into a desired 3D shape configuration. In specific examples, one or more heat-treated jigs (e.g., but not limited to customized) are provided for each jaw of a patient. For example, the shape and configuration of the heat-treated jigs 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 welded by powder bed welding, or steel / copper mixtures sprayed with binder, and first constructing in wax and then casting the wax mold into various metals. In the various examples described herein, the heat-treated jigs can be made of materials that have sufficient resistance to the temperatures of heat treatment. In specific examples, with or without the use of one or more heat-treated jigs, one or more robots can be used to bend cut planar members into a desired 3D shape configuration.

[0508] In some embodiments, a single shape-setting step may be performed to deform the member from its planar configuration to its desired 3D configuration. However, in some embodiments, shape setting may include two or more shape-setting steps (e.g., two or more heat treatment processes, possibly using two or more different heat treatment fixtures). In this case, the amount of deformation applied to the orthodontic appliance within each shape-setting step may be limited, with each subsequent shape-setting step moving the orthodontic appliance further toward the desired 3D configuration.

[0509] The completed appliance (optionally along with a bonding tray and / or fixation members) can then be sent to the treating clinician. To install the appliance, the orthodontist can clean the lingual surfaces of the patient's teeth to prepare them for bonding (e.g., using pumice powder). The tooth surfaces can then be sandblasted (e.g., with 50-micron alumina). The fixation members can then be attached using a bonding tray as described elsewhere in this document.

[0510] After the appliance is manufactured and the fixation element is attached to the teeth, each arm can be coupled to its corresponding fixation element to mount the appliance. Once mounted, the appliance applies force and torque to the teeth to move them to the desired free taper (FTA). After treatment is complete (e.g., OTA to FTA, OTA to ITA, ITA to ITA, or ITA to FTA), the arm can be passively positioned within the fixation element and no longer apply force to the teeth. Alternatively, any residual force applied by the arm may be below a threshold that would cause further tooth displacement.

[0511] The patient can return for a check-up appointment (e.g., approximately 2-3 months later). If treatment is progressing as planned, no further intervention is required until the patient returns at the scheduled time for appliance removal. During this stage, the fixation components can be removed. If treatment is not progressing as planned, the appliances can be removed, the patient's mouth rescanned, and a new appliance designed and installed based on the revised treatment plan.

[0512] Four, Application of Finite Element Analysis in the Design of Orthodontic Appliances and Treatment Fixtures

[0513] As previously described, in some embodiments, the design and / or manufacture of orthodontic appliances (or components thereof) or heat-treated fixtures (or components thereof) may include the use of computer-aided analysis or automated computer analysis. In some embodiments, such computer-aided analysis may include obtaining one or more digital models and performing finite element analysis (FEA) using one or more such models. For example, digital models characterizing or representing a patient's teeth, gingiva, maxilla, mandible, and / or other anatomical structures of the oral cavity (e.g., whether in OTA, ITA, or FTA), orthodontic appliances (e.g., planar form, 3D pre-installed form, deformable configuration, etc.), and / or heat-treated fixtures may be obtained. As described in more detail below, FEA can be used to evaluate the design and configuration of orthodontic appliances and / or heat-treated fixtures prior to manufacture. Therefore, the design can be corrected, improved, or otherwise modified based on the evaluation before manufacturing, thereby reducing costly errors and improving device design.

[0514] As previously described, the orthodontic appliance of this technology can have a planar form corresponding to a flat or substantially two-dimensional (2D) configuration, a pre-installation form corresponding to a substantially three-dimensional (3D) configuration of the manufactured appliance (e.g., the shape of the appliance after heat treatment), and / or an installation form corresponding to the substantially 3D configuration of the appliance at the start of treatment once installed in the patient's mouth (e.g., the appliance is attached to the patient's teeth in OTA or ITA). According to some embodiments, the pre-installation form of the appliance can be created by attaching the planar appliance to a heat-treated fixture and heat-treating the appliance and fixture to form the 3D contour shape of the appliance, as previously described. In some embodiments, the pre-installation form of the appliance can be created by any suitable process, including, for example, 3D-printed appliances, mechanically deformable appliances, etc. In some embodiments, the pre-installation form of the appliance can substantially correspond to the patient's teeth in an OTA, FTA, and / or heat-treated fixture. For example, the pre-installation form of the appliance can be formed by heat-treating the appliance while it is being attached to the heat-treated fixture. In some embodiments, when the appliance is attached to a heat-treated clamp, the anchors substantially conform to the gingival surface of the heat-treated clamp, and the arms substantially conform to the retaining portion of the heat-treated clamp. As previously described, in these and other embodiments, the gingival surface of the heat-treated clamp may originate from and / or substantially correspond to the patient's gingiva in the OTA or FTA. Each form of the appliance may be virtually represented as a unique digital model. For example, a planar appliance may be virtually represented as a planar appliance digital model.

[0515] In some cases, it may be beneficial to evaluate the expected orthodontic appliance design before manufacturing the physical appliance based on the intended appliance design to assess its performance during treatment. For example, because the pre-installed form of the appliance is at least partially based on the desired FTA (Free-Tooth Accommodation), the position of one or more parts of the appliance may shift relative to the gingiva once the physical appliance is installed in the patient's mouth (e.g., the patient's teeth are in an OTA or ITA). As a result, one or more shifted positions of the physical appliance may cause patient pain, which may reduce treatment adherence and / or satisfaction. For example, the anchor member of the appliance may be used adjacent to and slightly spaced from the patient's gingiva throughout treatment. In the installed form, the anchor member may be located too far from the gingiva and irritate the tongue, or too close to the gingiva and exert painful pressure on the gingiva. Therefore, one or more systems and methods of this technique can evaluate the position of the appliance relative to local anatomy, such as the position of the anchor member relative to the gingiva, after the appliance is installed in the patient's mouth. Based on the evaluation, one or more parameters of the heat-treated clamp or appliance can be modified.

[0516] Furthermore, when a physical orthodontic appliance is installed in a patient's mouth, the appliance deforms from its pre-installed form to its installed form, and significant strain may occur in certain parts of the appliance (e.g., the arms). If the strain in the appliance exceeds the elastic limit of the appliance material, plastic deformation may occur, altering the force applied by the appliance. Therefore, one or more systems and methods of this technology can assess the potential plastic deformation of the appliance and, based on this assessment, modify one or more parameters of the appliance, such as the geometry of the arms, the geometry of the 3D pre-installed form, and / or the position of the fixation members on the teeth.

[0517] The orthodontic appliance of the present invention can be configured to apply forces and / or torques to a patient's teeth to move them from an original position (e.g., OTA or ITA) to another position (e.g., ITA or FTA). As previously described, various parameters of the orthodontic appliance design, such as arm geometry, anchor geometry, material properties, etc., can be selected and adjusted based on the expected forces and / or torques applied to the teeth. In some cases, it may be beneficial to assess the forces and / or torques that the expected appliance design will apply to the patient's teeth before physically manufacturing the appliance to determine whether the physical appliance based on the expected appliance design will perform as intended. Therefore, one or more systems and methods of the present technology can assess the forces and / or torques that the expected appliance and / or heat-treated clamp design will apply to the patient's teeth, and based on this assessment, modify one or more parameters of the appliance and / or heat-treated clamp.

[0518] To address the aforementioned challenges, one or more processes can be performed before manufacturing and installing the physical appliance in a patient's mouth to evaluate the intended appliance design by virtually deforming a digital model of one form of appliance to produce a digital model of another form. For example, a digital model of a pre-installed appliance can be deformed to obtain a digital model of an installed appliance. The output of the virtual deformation can be evaluated to assess whether the physical appliance will function as expected, and based on the evaluation of the output, the intended appliance design can be modified, or the final appliance design can be obtained.

[0519] Some or all of the analyses described herein can be performed using appropriate computing devices (e.g., computing device 404 previously described). These processes can be performed on a single computing device or a cluster of computing devices working collaboratively, or various processes can be performed by remote or distributed computing devices, with different steps performed by different entities and / or different computing devices. For example, some or all of the analytical processes described herein can be performed in a distributed computing environment, where tasks or modules are performed by remote processing devices linked via a communication network (e.g., wireless communication networks, wired communication networks, cellular communication networks, the Internet, short-range radio networks (e.g., via Bluetooth)). In various embodiments, some or all of the processes described herein can be performed automatically. According to some embodiments, some of the processes described herein may rely at least in part on one or more inputs from a human operator such as a clinician or technician.

[0520] Figure 19 This is a flowchart of process 1900 for determining the design of an orthodontic appliance. In some embodiments, process 1900 may include obtaining an anatomical digital model (process section 1902) that represents or characterizes the geometry of a patient's teeth and / or gingiva in an arrangement. This arrangement may be an original dentition alignment (OTA), intermediate dentition alignment (ITA), or final dentition alignment (FTA). In some embodiments, the anatomical digital model may be a modified representation of the patient's teeth and / or gingiva. For example, the anatomical digital model may represent a heat-treated clamp based on the OTA and / or the desired FTA, wherein the heat-treated clamp includes modifications to the OTA and / or FTA, such as increasing the thickness of the gingival surface or adding structural features, as previously described herein. Process 1900 may include obtaining an appliance digital model (process section 1904) that represents the orthodontic appliance in a particular form. For example, the appliance digital model may be a planar appliance digital model that represents the orthodontic appliance in a substantially flat or 2D configuration.

[0521] Process 1900 can continue at process section 1906, virtually deforming the orthodontic digital model based on the anatomical digital model. Process 1900 can perform the virtual deformation 1906 using finite element analysis (FEA), finite difference methods, finite volume methods, or any other suitable numerical method. For example, virtually deforming the orthodontic digital model 1906 can include performing FEA using the orthodontic digital model and the anatomical digital model to deform the orthodontic digital model based on the positional difference between a portion of the orthodontic digital model and a portion of the anatomical digital model. Process 1900 can obtain the output of the virtual deformation at process section 1908, and can evaluate the output in process section 1910. The output can include the virtually deformed orthodontic digital model, the anatomical digital model, and / or data generated by the virtual deformation, such as displacement, force, strain, stress, or relative position. Evaluating the output can include a quantitative comparison of the executed output with a predetermined threshold or parameter. In some embodiments, evaluating the output can include a qualitative evaluation of the executed output. For example, a human operator can visually inspect the output. Based on the evaluation of output 1910, process 1900 can continue to modify one or more of the previously obtained digital models (process section 1912). For example, process 1900 can determine that the strain in the orthodontic digital model exceeds a predetermined threshold and modify the geometry of one or more portions of the orthodontic digital model to reduce the strain. Based on the evaluation of output 1910, process 1900 can proceed to process section 1914 and output one or more previously obtained digital models. The one or more digital models output by process section 1914 can be used to manufacture physical orthodontic appliances and / or fixtures, as previously described.

[0522] Figure 20 An example process 2000 for evaluating orthodontic appliance design is shown. In some embodiments, each process portion of process 2000 may be performed automatically or manually, for example, by a human operator. Process 2000 may begin at process portion 2002, obtaining a digital model 1200 of a heat-treated fixture. Figure 12 An example of a heat-treated fixture model 1200 is shown, as described above. As previously stated, the heat-treated fixture digital model 1200 may correspond to an OTA and / or a desired FTA and / or be derived from it, with certain modifications (e.g., gingival enlargement). In the process section 2004, a planar orthodontic appliance digital model 1500 is available. (The above...) Figure 15An example of a planar orthodontic appliance digital model 1500 is shown. As previously described, the planar orthodontic appliance digital model 1500 may have a substantially flat or 2D configuration and may virtually represent an appliance design including anchors and / or multiple arms. In some embodiments, the planar orthodontic appliance digital model 1500 may include a thickness dimension, which may be uniform across the appliance or may vary across different portions of the appliance. Process 2000 may continue in process section 2006, performing a first FEA based on the heat-treated fixture digital model 1200 via the planar orthodontic appliance digital model 1500. For example, the first FEA may generate a desired appliance digital model, wherein the planar orthodontic appliance digital model 1500 has been deformed based on features of the heat-treated fixture model 1200 (e.g., fixation portion 1202, gingival surface 1210) to produce a profile or 3D appliance (e.g., as shown) with a shape and configuration similar to the completed appliance 10. Figure 16 (As shown). In some embodiments, process 2000 may use suitable commercial FEA software (e.g., Abaqus, Ansys) and / or suitable proprietary FEA software to perform the first FEA.

[0523] While some embodiments describe the use of a heat-treated fixture digital model 1200 to generate a 3D or contour configuration of the orthodontic digital model, in some embodiments, an FTA digital model (e.g., FTA models 800 or 1100 described above) may be used. For example, a planar orthodontic digital model 1500 may be deformable to conform to the surface of an FTA digital model without requiring a heat-treated fixture digital model 1200.

[0524] In some embodiments, performing the first FEA in process section 2006 may include meshing one or more digital models, wherein meshing includes discretizing the digital model into multiple finite elements and multiple nodes. Meshing may be performed, for example, manually by a human operator and / or automatically using suitable software. Suitable software may include commercial meshing software (e.g., Commercial FEA software (such as Abaqus) and / or proprietary meshing software with meshing capabilities are available. Finite element methods (FEA) can have dimensions based on the geometry of the digital model, including but not limited to 2D (e.g., triangles, quadrilaterals) or 3D (e.g., tetrahedrals, quadrilaterals) elements. For example, the FEA used for a planar orthodontic digital model 1500 may include hexahedral 3D elements. Element parameters (e.g., element type, element order, number of integration points, hourglass control) can be selected to control the accuracy and stability of the FEA. In some embodiments, performing the FEA may include meshless techniques, such as an element-free Galerkin process, a generalized-strain mesh-free formulation, isogeometric analysis, or a process of external approximations.

[0525] Performing the first FEA in process section 2006 may include assigning material properties (e.g., Young's modulus, Poisson's ratio, density) to the planar orthodontic appliance digital model 1500 and the heat-treated fixture digital model 1200. For example, the material properties of nitinol may be assigned to the planar orthodontic appliance digital model 1500, such as a Young's modulus between approximately 28 GPa and 83 GPa. In some embodiments, the heat-treated fixture model 1200 may be represented as a deformable component with brass material properties, such as a Young's modulus between approximately 100 GPa and 130 GPa. In some embodiments, the heat-treated fixture digital model 1200 may be represented as a rigid component, such that the heat-treated fixture digital model 1200 does not deform during the first FEA. By assigning an artificially large Young's modulus to the heat-treated fixture digital model 1200, the heat-treated fixture digital model 1200 may be represented as a rigid component. Process 2000 may obtain material properties from a database and / or may manually input material properties.

[0526] In some embodiments, performing a FEA (process section 2006) may include defining contact interactions between at least a portion of the orthodontic appliance digital model 1500 and at least a portion of the heat-treated fixture digital model 1200. Defining contact interactions may include creating a first contact surface by selecting digital nodes, elements, and / or surfaces of the planar orthodontic appliance digital model 1500. Another contact surface may be created by selecting digital nodes, elements, and / or surfaces of the heat-treated fixture digital model 1200. Defining contact interactions may further include defining a contact formulation to control the contact interactions between the contact surfaces. The type of contact formulation (e.g., adhesive, frictional, frictionless, etc.) may be selected from a database of contact formulations and / or may be manually entered. The process may also include entering relevant parameters of the contact formulation, including but not limited to the coefficient of friction, penalty contactstiffness, and / or node search distance. For example, in some embodiments, an adhesive contact interaction may be defined between the attachment portion 140 of the orthodontic digital model 1500 and the horizontal channel 1204, vertical channel 1206, and / or fixation portion 1202 of the heat-treated clamp digital model 1200. In some embodiments, a sliding contact interaction may be defined between the attachment portion 140 of the orthodontic digital model 1500 and the fixation portion 1202 of the heat-treated clamp digital model 1200. For example, a sliding contact interaction may be defined as simulating the interaction between the attachment portion and the fixation member.

[0527] Performing FEA in process section 2006 may include assigning boundary conditions to at least one of the digital models. In some embodiments, boundary conditions may include constraints to prevent translation and / or rotation of one or more portions of one or more digital models. For example, boundary conditions may include constraints on one or more attachment portions 140 of the heat-treated jig digital model 1200 and the planar appliance digital model 1500. Additionally or alternatively, boundary conditions may include non-zero forces, moments, displacements, and / or rotations. For example, to virtually deform the planar appliance digital model 1500 into a profile or 3D digital model representing a pre-installed form of the appliance, a non-zero displacement may be applied to a portion of the anchor member 20 of the planar appliance digital model 1500. When the attachment portion 140 of the planar appliance digital model 1500 is located within the fixed portion 1202 of the heat-treated jig digital model 1200, the non-zero displacement may correspond to the distance between the anchor member 20 and the distal gingival surface 1210 of the heat-treated jig digital model 1200. In some embodiments, by applying a non-zero displacement to the attachment portion 140 of the planar orthodontic digital model 1500, such that the attachment portion 140 is located within the corresponding fixing portion 1202 of the heat-treated clamp digital model 1200, the planar orthodontic digital model 1500 can be virtually deformed into a contour or 3D digital model representing a pre-installed form of the orthodontic appliance. Additionally or alternatively, a non-zero displacement may be applied to the attachment portion 140 and / or arm 130 of the planar orthodontic digital model 1500 such that the attachment portion 140 and / or arm 130 are tangent to the base plane of the corresponding fixing portion 1202 of the heat-treated clamp digital model 1200.

[0528] In some embodiments, performing a FEA in the process section 2006 may include defining one or more analysis parameters, such as analysis type (e.g., static or dynamic), geometric linearity, integration scheme (e.g., implicit, explicit), simulation duration, increment size, and / or increment control. Performing a FEA may include running the FEA until an exit condition is met. For example, running the FEA may include applying a non-zero displacement to the planar orthodontic digital model 1500, wherein an exit condition is met once a non-zero displacement of the full order of magnitude has been applied.

[0529] Return to reference Figure 20 Process 2000 can continue in process section 2008 to obtain the expected digital model 2102 of the orthodontic appliance, which virtually represents the pre-installed form of the appliance. For example... Figure 21As shown, the digital model 2100 generated by the first FEA (process section 2006) may include a prospective orthodontic digital model 2102 representing a pre-installed form of the orthodontic appliance in profile construction and matched with the heat-treated fixture model 2104. The prospective orthodontic digital model 2102 obtained in process section 2008 can be obtained from the first FEA performed in process section 2006 of process 2000. In some embodiments, the prospective orthodontic digital model 2102 representing the outline or 3D configuration of the manufactured orthodontic appliance can be obtained without performing the first FEA. For example, it can be obtained directly from CAD software (e.g., Inventor MeshMixer The expected orthodontic appliance digital model 2102 can be obtained from a scan of the physical representation of the orthodontic appliance (e.g., a manufactured orthodontic appliance, an orthodontic mold, etc.). In the process section 2010, an OTA digital model can be obtained, which virtually represents the patient's teeth in the original arrangement. For example, as described above... Figure 10 The OTA digital model 1000 with attached fixation members can be used. In some embodiments, the OTA digital model may include a modified representation of the patient's teeth and / or gingiva. For example, the OTA digital model may have features similar to the heat treatment clamp 1200 (e.g., having a horizontal channel 1204 and / or a vertical channel 1206, a fixation portion 1202 of a stabilizing crossbar 1212) to replace or supplement a virtual representation of the patient's actual teeth and / or gingiva. For example, in some embodiments, the position of the fixation portion in the patient's teeth in the original arrangement may replace the virtual representation of the patient's actual teeth in the OTA digital model. According to some embodiments, the OTA digital model may include a dataset comprising positional data representing the spatial coordinates of the patient's teeth in the original arrangement.

[0530] Return to reference Figure 20 Process 2000 can continue to perform a second FEA (process section 2012) through the expected orthodontic digital model 2102 and the OTA digital model to produce an expected orthodontic digital model representing the deformation of the orthodontic in the installation form. Figure 22 An example of digital model 2200 is shown, which includes a modified version of the intended orthodontic digital model 2202 that matches the OTA digital model 1000. Figure 22As shown, the deformed expected orthodontic appliance digital model 2202 can virtually represent the appliance in its installed form in the patient's mouth (e.g., in OTA or ITA). For example, by a second FEA, the expected orthodontic appliance digital model 2102 (e.g., characterizing the appliance in its pre-installed form) can be virtually deformed into its installed form, wherein the appliance mates with the patient's teeth in the OTA (or ITA), as reflected in the OTA digital model 1000. This virtual deformation can produce the deformed expected orthodontic appliance digital model 2202, which can effectively simulate the real-world behavior of a manufactured orthodontic appliance when installed in the patient's mouth. Thus, the evaluation of the deformed expected orthodontic appliance digital model 2202 allows human operators and / or automated processes to evaluate and / or predict the operation and performance of the appliance when installed in the patient's mouth.

[0531] In some embodiments, performing a second FEA may include discretizing(multiple) digital models, assigning material properties, defining any contact interactions, assigning boundary conditions, defining any analysis parameters, and / or running the FEA until the exit conditions as described above are met. For example, assigning boundary conditions to perform the second FEA may include determining the displacement of each tooth between the FTA and OTA. As previously described, the displacement of a tooth can be defined using six degrees of freedom by calculating the difference between the positions of each tooth in the FTA and OTA data. Assigning boundary conditions may include assigning the displacement of each tooth between the FTA and OTA to the corresponding attachment portion of the intended orthodontic appliance digital model 2102. Assigning boundary conditions may include assigning constraints to prevent rotation and / or translation of one or more portions of the OTA digital model 1000 and / or the intended orthodontic appliance digital model 2102.

[0532] Return to reference Figure 20 In the process section 2014, process 2000 can obtain the expected deformable digital model 2202 of the orthodontic appliance. Figure 22The deformed expected orthodontic appliance digital model 2202 and / or analysis results can be obtained from the second FEA. The deformed expected orthodontic appliance digital model 2202 can virtually represent the installed orthodontic appliance after it has been installed in the patient's mouth (e.g., the appliance is attached to the patient's teeth in an OTA or ITA). Analysis results can include output data from the second FEA. For example, analysis results can be measurements of position, displacement, rotation, force, torque, stress, or strain in one or more digital models used in the second FEA. Process 2000 can continue in process section 2016 to evaluate the analysis results. In some embodiments, evaluating the analysis results includes comparing the analysis results to one or more predetermined thresholds. Based on the evaluation of the analysis results, process 2000 can continue in process section 2018 and modify the planar orthodontic appliance digital model 1500 and / or the heat-treated fixture digital model 1200.

[0533] In various embodiments, modifying the digital model of an orthodontic appliance (e.g., a planar orthodontic appliance digital model 1500 or a 3D orthodontic appliance digital model) may include modifying the specific shape and / or configuration of the anchors and / or arms of the appliance, the geometry of the 3D pre-installed form of the appliance, and / or the position of the fixation members on the teeth. For example, features of one or more arms may be modified, including but not limited to the total length of the arm, the shape or construction of the offset portion, the shape or configuration of the bracket connector, the width dimension of one or more portions of the arm, the thickness dimension of one or more portions of arm 130, etc. Features of the anchors that may be modified include, but are not limited to, the shape, length, thickness, depth, or other attributes of the anchors. In some embodiments, a human operator may manually select or modify the design and configuration of the anchors and / or arms as needed. In some embodiments, one or more arms may be replaced based on a pre-filled library of arm designs. In some embodiments, an operator may review and / or modify fully or partially automated modifications to the digital model of the orthodontic appliance or the digital model of the heat-treated fixture based on relevant standards.

[0534] Figure 23 An example of the analysis results of the expected orthodontic appliance digital model 2202, reflecting deformation in a configuration matching the patient's teeth and reflected in the OTA digital model 1000, is shown. The analysis results may include strain measurements in the orthodontic appliance digital model 2202. Strain measurements may include, for example, a single maximum strain in the appliance, the volume of elements exceeding a strain threshold, and / or the average strain of a portion of the appliance. Figure 23As shown, strain measurements can be displayed by process 2000 as a heat map superimposed on the orthodontic digital model 2202. This heat map (or other graphical representation) can visually indicate the strain at different regions of the orthodontic digital model 2202. In some embodiments, the strain measurement can be a single number and / or a set of numbers. Process 2000 can compare the strain measurement with a predetermined maximum strain threshold in process section 2016. In some embodiments, the predetermined maximum strain can be the elastic limit of the orthodontic material. For example, the predetermined maximum strain for nitinol can be between about 4% and about 10%. If the strain measurement exceeds the predetermined maximum strain threshold, process 2000 can proceed to process section 2018 and modify the planar orthodontic digital model 1500. Modifying the planar orthodontic digital model can include, for example, increasing the thickness of one or more portions of the orthodontic appliance, selecting different geometries for the arm or anchor portions of the appliance, etc.

[0535] In some embodiments, the analysis results may include forces and / or torques to assess the forces and / or torques applied by the orthodontic appliance to the patient's teeth. For example, the analysis results may be reaction forces and / or torques measured at a portion of the anchorage of the orthodontic appliance digital model 2202, the fixation member of the OTA digital model 1000, the teeth of the OTA digital model, or any other suitable location. The location for measuring the forces and / or torques may be based at least in part on boundary conditions specified in the second FEA. In some embodiments, evaluating the analysis results (process section 2016) includes comparing the forces and / or torques to predetermined values. In some embodiments, the predetermined values ​​may correspond to expected forces and / or torques. The difference between the measured and expected forces and / or torques can be obtained and evaluated to determine whether the physical orthodontic appliance, based on the expected appliance design, will adequately apply the expected forces and / or torques and perform as expected. In some embodiments, the predetermined values ​​may be safety thresholds corresponding to the maximum permissible forces of the appliance and / or patient anatomy. According to some embodiments, the predetermined values ​​are minimum forces and / or torques, a range of permissible forces and / or torques, or any other suitable metric. Based on a comparison of force and / or torque with predetermined values, process 2000 may modify one or more parameters of the planar orthodontic digital model 1500, the heat treatment fixture digital model 1200, the expected orthodontic digital model 2100, or another suitable digital model.

[0536] Another example of the analysis results includes identifying parts of the orthodontic appliance that may be impacting the patient's gums. For example, such as... Figure 23As shown, in region 2302, a portion of the orthodontic appliance digital model 2202 has penetrated below the gingival surface of the OTA digital model 1000. This is likely a result of the model being deformed from the intended orthodontic appliance digital model 2102 to the previously described deformed orthodontic appliance digital model 2202. The intersection shown in region 2302 can indicate areas where a real-world manufactured orthodontic appliance risks contacting the patient's gums during installation. Such contact can be uncomfortable and irritate the patient's gums. Therefore, as a result of identifying such contact points, the orthodontic appliance design can be modified (e.g., by modifying the planar orthodontic appliance digital model 1500), the pre-installation form of the appliance can be modified (e.g., by modifying the heat-treated clamp model 1200), or any other appropriate modifications, corrections, or compensations can be made.

[0537] Figure 24 Another example of the analysis results based on the assessment of the relative positions of the deformed orthodontic appliance digital model 2202 and the OTA digital model 1000 is shown. For example, as Figure 24 As shown, due to the shape and configuration of the orthodontic appliance, a portion of the orthodontic appliance digital model 2202 is spaced apart from the gingival surface of the OTA digital model 1000 by a local distance 2400. An excessive gap between the appliance and the patient's gums can irritate the patient's tongue and cause pain and / or discomfort. Therefore, in some embodiments, the analysis may include determining whether the local distance 2400 is greater than a predetermined maximum distance threshold. Figure 24 In the example shown, the analysis results may include a local distance 2400 between a portion of the deformed expected aligner digital model 2202 and a portion of the lingual surface of the patient's gingiva in the OTA digital model 1000, which exceeds a predetermined maximum distance threshold. In some examples, the maximum distance threshold between the portion of the deformed expected aligner digital model and the portion of the lingual surface of the patient's gingiva may be between approximately 0 mm and approximately 5 mm. If the local distance 2400 is greater than the maximum distance threshold, process 2000 may modify one or more digital models (process section 2018) to modify the relative position of the aligner in the mounting form to the patient's gingiva. For example, the thickness of the gingival surface of the heat-treated clamp digital model 1200 may be increased and / or decreased at one or more locations. Process 2000 may be repeated with the modified digital model(s) to determine whether the local distance 2400 is below the maximum distance threshold and whether the modified digital model(s) is a more advantageous design.

[0538] It may be advantageous to separate the anchor 20 of the orthodontic appliance from the patient's gingiva to minimize irritation to the patient's gingiva due to the appliance. Therefore, in some embodiments, the analysis results may include a local distance 2400 between a portion of the deformed intended orthodontic appliance digital model 2202 and a portion of the lingual surface of the patient's gingiva in the OTA digital model 1000, which is less than a predetermined minimum distance threshold. In some examples, the minimum threshold may be between approximately 0.00 mm and 0.5 mm. If the local distance 2400 is less than the minimum distance threshold, process 2000 may modify one or more digital models (process section 2018). For example, the thickness of the gingival surface of the heat-treated clamp digital model 1200 may be increased and / or decreased at one or more locations. This modification may alter the pre-installed form of the orthodontic appliance. Process 2000 may be repeated with the modified digital model(s) to determine whether the local distance falls above the minimum threshold.

[0539] According to some embodiments, process 2000 can be repeated iteratively until a favorable orthodontic appliance design is obtained. For example, Figure 25 Four modified digital models 2500a, 2500b, 2500c, and 2500d of the anticipated orthodontic appliance were depicted, matched with an OTA digital model 1000 representing the patient's teeth in their original alignment. As a result of the second FEA, the first orthodontic appliance digital model 2500a has penetrated the gingival surface of the OTA digital model 1000 in the first intersection region 2502a. Process 2000 can modify one or more digital models based on this analysis result (process section 2018), and repeat process sections 2002 to 2016 with the modified one or more digital models until the final appliance design is obtained. For example, Figure 25 The second orthodontic appliance digital model 2500b is shown, which penetrates the gingival surface of the OTA digital model 1000 to a less extent than the first orthodontic appliance digital model 2500a, forming a second cross region 2502b smaller than the first cross region 2502a. The third orthodontic appliance digital model 2022c forms a third cross region 2502c smaller than the first cross region 2502a and the second cross region 2502b. Figure 25The fourth orthodontic appliance digital model 2502d depicted does not penetrate the gingival surface of the OTA digital model 1000 and can be an advantageous appliance design. Based on the advantageous fourth orthodontic appliance digital model 2502d, process 2000 can stop iteratively repeating and select the final appliance design. In some embodiments, a human operator can select the final appliance design. In some embodiments, the final appliance design can be selected automatically and / or by a human operator based on quantitative measures (e.g., but not limited to changes in analysis results between iterations, comparisons of analysis results with predetermined thresholds or parameters, etc.). Alternatively or additionally, process 2000 can stop repeating and select the final appliance design if a predetermined maximum number of iterations has been reached.

[0540] In some embodiments, the digital model 1200 of the heat-treated clamp can be modified based on the final appliance design. For example, the gingival surface 1210 of the heat-treated clamp 1200 can be modified such that when the attachment portion of the appliance is located within and tangent to the base plane of the fixation portion 1202 of the heat-treated clamp 1200, the lingual gingival surface 1210 of the heat-treated clamp 1200 is tangent to the gingival-facing surface of the appliance.

[0541] After selecting the final appliance design and / or the final heat-treated fixture design, process 2000 can proceed to process section 2020 and output a planar appliance digital model 1500, a heat-treated fixture digital model 1200, and / or a proposed appliance digital model 2102. Based on the outputs in process section 2020, the appliance and / or heat-treated fixture can be manufactured, for example, using any of the techniques previously described herein.

[0542] IV. Selected equipment, systems, and methods for manufacturing orthodontic appliances based on overcorrection and / or compensation parameters.

[0543] As previously described, the manufacturing process for creating an orthodontic appliance (e.g., an orthodontic appliance or clamp) according to embodiments of the present technology may include obtaining data corresponding to the patient's OTA (Overall Occlusion), and then using this data to develop an FTA (Free Assisted Aspect) model of the patient's teeth in optimal position. The FTA model can be used as a basis for creating a clamp (e.g., a heat-treated clamp) that typically corresponds to the FTA but has one or more modifications (as discussed elsewhere herein). The clamp can then be used to form a 3D configuration of the appliance (e.g., a curved or contoured configuration of the appliance that, when mounted in the patient's mouth, can push the teeth from the OTA to the FTA). For example, as described elsewhere herein, a substantially planar configuration of the appliance can be manipulated and / or arranged on the clamp, and then heat-treated on the clamp so that the appliance takes on a 3D shape that generally conforms to the clamp.

[0544] Manufacturing orthodontic appliances in this manner should enable them to precisely replicate the aforementioned Free Tag Alignment (FTA) and, upon installation, reposition the patient's teeth from the Over-Alignment (OTA) to the desired FTA. However, in practice, several factors can cause a difference between the desired FTA and the actual final alignment of the patient's teeth after repositioning by the appliance. As described in more detail below, such differences may be due to: (a) implementation considerations (e.g., the minimum threshold force required to move the patient's teeth, and / or the free clearance or tolerance between the appliance and the fixation components), (b) the material properties of the appliance (e.g., plastic deformation, hysteresis, etc.), (c) irregularities associated with the manufacturing process, and / or (d) the expected tooth movement after repositioning (e.g., relapse). To mitigate these problems, embodiments of the present technology may take these differences into account and modify the design parameters of the clamps and / or appliances during or before manufacturing (e.g., through overcorrection or compensation).

[0545] Those skilled in the art will recognize that, although embodiments of the present technology relating to overcorrection or compensation are described below as individual parameters or factors, any factors described in a single embodiment can be combined. For example, the design or manufacture of orthodontic appliances and / or clamps may take into account the minimum threshold force required to move the patient's teeth and irregularities associated with the manufacturing process.

[0546] A. Considerations related to the implementation of orthodontic appliances

[0547] As previously described, orthodontic appliances of this technology are typically designed and manufactured, at least in part, based on the forces (e.g., load / torque / magnitude and / or direction) required to reposition a patient's teeth (e.g., individual teeth) from the over-the-air (OTA) to the desired or optimal free-adjustment (FTA). In some embodiments, these appliances may take into account external factors acting upon them (e.g., the minimum threshold force required to move the patient's teeth and / or the free clearance between the appliance and the fixation member), which in turn affect the necessary forces that the appliance and / or one or more parts thereof must provide on the patient's teeth to result in the desired repositioning to the FTA.

[0548] 1. Minimum threshold force for moving a patient's teeth

[0549] As previously described, the orthodontic appliance of this technology is configured to move a patient's teeth from the OTA (Original Orthodontic Domain) to a defined FTA (Free Target Accommodation) along a path. More specifically, each arm of the appliance is configured to move a corresponding patient tooth from its original position to its corresponding final position along a corresponding path. When the appliance is under load or stress, the force applied to the patient's teeth by the appliance, or in some embodiments, by the corresponding arm of the appliance, is generally highest at or near the OTA and decreases as the patient's teeth approach the FTA when the appliance is unloaded or unstressed. Therefore, the appliance typically applies minimal force to the teeth when they approach the FTA. However, due to various external factors, such as the root of a particular tooth or the position of the tooth within the gum line, there may be a minimum threshold force that must be overcome to move each tooth. That is, a force less than the minimum threshold force applied to the teeth by the arms of the appliance will not move the teeth. Therefore, if the appliance in an unloaded state is manufactured to resemble or otherwise correspond to the FTA without considering this minimum threshold, the movement of the patient's teeth may stop before actually reaching the FTA.

[0550] To further illustrate this point, Figure 26 This is a graph 2600 showing the relationship between the force applied to the patient's teeth on the y-axis and the position of the patient's teeth on the x-axis. (See graph 2600.) Figure 26 As shown, line 2610 corresponds to the minimum threshold force required to move the patient's teeth, line 2620 corresponds to the force applied to the patient's teeth, for example, by the first appliance, during the movement from the OTA to the first final tooth alignment (FTA1), and line 2630 corresponds to the force applied to the patient's teeth, for example, by the second appliance, during the movement from the OTA to the second final tooth alignment (FTA2). In some embodiments, the minimum threshold force may be at least about 5 g / f (GF), 10 GF, 15 GF, 20 GF, 25 GF, or 50 GF. The first appliance has a no-load or no-stress state corresponding to the first final tooth alignment (FTA1), which is the optimal tooth alignment determined for the patient, and the second appliance has a no-load state corresponding to a second final tooth alignment (FTA2) different from the first final tooth alignment (FTA1).

[0551] like Figure 26As shown, lines 2620 and 2630 represent a generally linear relationship between the force applied to the patient's teeth and their positioning. However, those skilled in the art will understand that in some embodiments, the relationship between the applied force and the positioning of the patient's teeth may be non-linear (e.g., exponential, logarithmic, etc.). Additionally or alternatively, in some embodiments, the relationship between the force applied to the patient's teeth and their positioning may be linear, non-linear, and / or constant, depending on the strain of the appliance and its portions (e.g., one or more arms of the appliance). For example, with respect to an appliance or arm comprising nitinol, the force applied to the patient's teeth via the nitinol appliance may be constant or nearly constant during a first portion of tooth movement and have a linear or non-linear relationship with the position of the patient's teeth during a second, different portion of tooth movement.

[0552] like Figure 26 As shown in line 2620, the first orthodontic appliance (manufactured with a no-load configuration corresponding to the first final tooth alignment (FTA1)) will reposition the patient's teeth from the OTA along a path toward the first final tooth alignment (FTA1). When implanted in the patient's mouth and fixed to a fixed member adhered to the patient's teeth (as previously described), this appliance will transition from a loaded configuration normally corresponding to the OTA to a no-load configuration normally corresponding to the first final tooth alignment (FTA1). However, due to the minimum threshold force (T) required to move the patient's teeth... MIN (As shown in line 2610), the first appliance will not move the patient's teeth all the way to the first final dentition (FTA1), but will move the patient's teeth only until the force provided by the appliance equals the minimum threshold force (T). MIN Until then, such as Figure 26 The position (P1) is shown in the middle.

[0553] Embodiments of this technology can be implemented by considering a minimum threshold force (T) when designing orthodontic appliances. MIN To mitigate the aforementioned problems, in some embodiments, the appliance may be designed and / or manufactured to have a second final dentition (FTA2) in its unloaded configuration, which differs from the first final dentition (FTA1). When implanted in the patient's mouth and fixed to a fixation member adhered to the patient's teeth, the second appliance is configured to reposition the patient's teeth from the OTA toward and / or toward the first final dentition (FTA1). In such embodiments, the second appliance is designed to provide a minimum threshold force (T) on the patient's teeth when the second appliance having an unloaded configuration corresponding to the second final dentition (FTA2) presents a configuration substantially corresponding to the first final dentition (FTA1). MIN ).like Figure 26As shown, the second appliance can be manufactured with a no-load configuration that approximately corresponds to the second final tooth alignment (FTA2). When implanted in the patient's mouth and fixed to the corresponding fixation member, the second appliance will reposition the patient's teeth from the OTA along a path toward the second final tooth alignment (FTA2), as shown in line 2630. Due to the minimum threshold force (T... MIN When the second appliance typically takes the first final tooth alignment (FTA1) and provides approximately equal minimum threshold force (T) on the patient's teeth, MIN When the force is applied, the movement of the patient's teeth via the second orthodontic appliance stops. For example... Figure 26 As shown, such an appliance is configured to apply a non-zero force to the patient's teeth when the teeth are repositioned to the first dentition (FTA1). The non-zero force can be (i) at least about 5GF, 10GF, 15GF, 20GF, 25GF, or 50GF, and / or (ii) not exceeding 500GF, 400GF, 300GF, 250GF, 100GF, or 50GF.

[0554] The above description of the minimum threshold force generally applies to the appliance and the patient's teeth; however, the same or similar principles also apply to the individual arms of the appliance and the individual teeth of the patient. For example, each arm of the appliance can be configured to move the corresponding patient tooth such that when the arm's position approximately corresponds to its position in the first final dentition (FTA1), the force provided via the arm is equal to the minimum threshold force (T). MIN Furthermore, the minimum threshold force required to move a particular tooth may differ slightly from that of other teeth, for example, depending on the tooth type (e.g., molars or incisors), the tooth position (e.g., relative to adjacent gingival surfaces), and / or other factors. Thus, when designing the corresponding parts of the appliance (e.g., arms, offset portions, attachment portions, etc.), the different minimum threshold forces for each tooth can be taken into account.

[0555] Figure 27 This is a flowchart of a method 2700 for determining a dataset associated with the placement of an orthodontic appliance according to an embodiment of the present technology. Method 2700 includes obtaining data corresponding to the patient's OTA (e.g., a first input) (process section 2702) and obtaining data corresponding to the patient's first FTA (e.g., a second input) (process section 2704). As described elsewhere herein, the OTA may be based on scans of the patient's teeth, and the FTA may be determined and / or provided by an operator (e.g., a clinician, orthodontist, or technician) based on the OTA and the desired optimal placement of the teeth.

[0556] Method 2700 may further include determining data (e.g., a third input) corresponding to a second FTA (different from the first FTA) (process section 2706) based in part on the minimum threshold force required to move at least one of the patient's teeth. The minimum threshold force may be a predetermined parameter, as it is known or can be determined prior to the manufacture of the apparatus. In some embodiments, the minimum threshold force may correspond to modifications typically applied to the orthodontic appliance (e.g., the same modification applied to each individual arm), or multiple different modifications applied to each individual arm of the orthodontic appliance. Additionally or alternatively, the minimum threshold may be determined based on factors generally common to all patients or factors specific to a particular patient. For example, in some embodiments, the minimum threshold under consideration may be based on the general anatomy of human teeth, such as molars or larger teeth having a larger minimum threshold than incisors or smaller teeth. As another example, in some embodiments, the minimum threshold under consideration may be based on a specific gingiva (e.g., gingival surface) surrounding a single tooth of the patient.

[0557] In some embodiments, method 2700 may omit process portion 2706 and include only a single FTA considering the minimum threshold force. In such embodiments, method 2700 may include obtaining first data corresponding to the patient's OTA and providing second data corresponding to the patient's FTA, wherein the second data is at least partially based on the minimum threshold force. In some embodiments, method 2700 may further include manufacturing the clamp and / or orthodontic appliance based at least on data corresponding to the second FTA. Such manufacturing of the clamp and / or orthodontic appliance may correspond to the manufacturing process described elsewhere herein.

[0558] 2. Free gap between the orthodontic appliance and the fixation component

[0559] As previously described, the orthodontic appliance of this technology is configured to move a patient's teeth from the OTA (Original Orthodontic Terminal) along a path to a defined FTA (Final Target Area). More specifically, each arm of the appliance is configured to move the corresponding patient's teeth from their original positions to their corresponding final positions along a corresponding path. Also as previously described, each arm is attached to a corresponding fixation member (e.g., a bracket) adhered to the corresponding tooth of the patient. Therefore, the force applied via each arm of the appliance is provided to the corresponding fixation member, and is thus applied to the corresponding individual patient's teeth to induce repositioning. In this respect, since the fixation member is a separate component from the appliance, there is typically some free clearance between each individual arm and its corresponding fixation member (due to, for example, manufacturing tolerances, gaps, wobble, or mismatch). In some embodiments, the free clearance is the same for each individual arm and its corresponding fixation member. Furthermore, in some embodiments, the free clearance between at least one individual arm and its corresponding fixation member is different relative to other individual arms and their corresponding fixation members. As a result of the free clearance, the force provided by a single arm may not be fully transmitted to the corresponding tooth, as a portion of the force is lost through the free clearance. For example, if a single arm is configured to move the corresponding tooth a given distance at a given rotation angle in a specific direction (e.g., mesial, distal, occlusal, gingival, buccal, and / or lingual) and / or around a specific axis (e.g., around the mesial-distal axis, the occlusal gingival axis, and / or the buccal-lingual axis), the free clearance can prevent the corresponding tooth from moving the entire distance and / or the entire rotation angle.

[0560] Figure 28A This is a perspective view of the fixing member 2800 according to an embodiment of the present technology. Figure 28B It is a link according to an embodiment of the present technology to Figure 28A A perspective view of a portion of the arm 2830 of the orthodontic appliance, shown as the fixing member 2800. Figure 28A As shown, the fixation member 2800 includes (i) a body region 2805 having a dorsal side or surface 2810 to be attached to a patient's tooth, (ii) a slot or recess 2812 within the body region 2805 configured to receive a portion of an orthodontic appliance or arm, and (iii) a movable clip portion 2820 coupled to the body region 2805, configured to fix a portion of the appliance or arm 2830 when positioned within the slot 2812. The slot 2812 may form a three-sided or U-shaped opening. Figure 28B As shown, arm 2830, or more specifically, the attachment portion 2840 of arm 2830, is disposed within slot 2812. Also as... Figure 28B As shown, the x-axis roughly corresponds to the buccal-lingual axis, the y-axis roughly corresponds to the occlusal gingival axis, and the z-axis roughly corresponds to the mesial-distal axis.

[0561] Figure 28C yes Figure 28B An enlarged cross-sectional side view of the fixing member 2800 and arm 2830 is shown, intended to further illustrate the aforementioned issues related to the free clearance between the fixing member 2800 and the attachment portion 2840. Figure 28C As shown, the attachment portion 2840 is disposed within the slot 2812, but one or more gaps 2880 (single gaps identified as 2880a-2880c) exist between the attachment portion 2840 and the respective adjacent surfaces of the slot 2812. Thus, rotation of the attachment portion 2840, for example in a first direction (R1), causes the attachment portion 2840 to rotate relative to the slot 2812, and therefore relative to the fixation member 2800. That is, the initial rotation of the attachment portion 2840 (as shown in (θ1)) does not transfer to the fixation member 2800 and / or the corresponding tooth of the patient. Such a transfer problem can occur (e.g., simultaneously) in one or more directions (e.g., mesial, distal, occlusal, gingival, buccal, and / or lingual directions) and / or around one or more axes (e.g., mesial-distal axes, occlusal gingival axes, and / or buccal-lingual axes). For example, a free gap between the attachment portion and the fixation member allows the attachment portion to rotate relative to the fixation member about the mesiodistal axis, the occlusal gingival axis, and / or the buccolingual axis. As a result, due to the gap between the attachment portion and the corresponding fixation member, this rotation will not transfer to the corresponding tooth. As another example, a free gap between the attachment portion and the fixation member allows the attachment portion to make some initial movements relative to the fixation member along the mesiodistal axis, the occlusal gingival axis, and / or the buccolingual axis. As a result, due to the gap between the attachment portion and the corresponding fixation member, this movement will not transfer to the corresponding tooth.

[0562] Figure 29A This is a perspective view of another fixing member 2900 configured according to an embodiment of the present technology, and is another example of the above-described concept regarding the free clearance between the arm of the orthodontic appliance and the fixing member. Figure 29A As shown, the fixation member 2900 includes (i) a body region 2905 having a first back or surface and a second opposite side or surface to be attached to a patient's tooth, and (ii) one or more connecting arms 2910 attached to the second side of the body region 2905. Each connecting arm 2910 may include a first elongated portion 2912 fixed to the body region 2905, and a second connecting portion 2914 extending from the first portion 2912 and partially spaced from the body region 2905. The connecting portion 2914 may define a slot or opening 2915 configured to receive and partially surround a portion of the orthodontic appliance or arm (e.g., Figure 29B (As shown). In some embodiments, the fixing member 2900 may be a commercially available product manufactured by Bernhard Foerster GmbH. Tongue-side bracket.

[0563] Figure 29B It is connected to Figure 29A A perspective view of a portion of the arm 2930 of the orthodontic appliance, shown as the fixing member 2900. Figure 29B As shown, arm 2930 includes an attachment portion or end portion 2940 having a region or extension 2965 disposed within slot 2915. Also as... Figure 29B As shown, when the arm 2930 and the fixation member 2900 are installed in the patient's oral cavity, the x-axis can roughly correspond to the buccal-lingual axis, the y-axis can roughly correspond to the occlusal gingival axis, and the z-axis can roughly correspond to the mesial-distal axis.

[0564] Figure 29C yes Figure 29B An enlarged side view of a portion of the fixing member 2900 and the attachment portion 2940 is shown, intended to further illustrate the aforementioned issues related to the free clearance between the fixing member 29000 and the arm 2930. Figure 29C As shown, region 2965 of the attachment portion 2940 is configured adjacent to the fixation member 2900 such that one or more gaps 2980 (single gaps identified as 2980a, 2980b, 2980c) exist between region 2965 and the corresponding adjacent surfaces of the connecting arm 2910 of the fixation member 2900. This free clearance between the attachment portion 2940 and the fixation member 2900 allows region 2965 to move relative to the connecting arm 2910 along the mesial-distal axis, the occlusal gingival axis, and / or the buccal-lingual axis. For example, as... Figure 29CAs shown, the free clearance between the attachment portion 2940 and the fixation member 2900 allows region 2965 to move a distance (D1) along the y-axis and / or a distance (D2) along the x-axis relative to the connecting arm 2910. As a result, due to one or more gaps 2980, this movement is not transferred to the corresponding tooth. As another example, rotation of region 2965 in the first direction (R1) can cause region 2965 to rotate relative to the connecting arm 2910, and thus relative to the fixation member 2900. That is, the initial rotation of region 2965 may not transfer to the fixation member 2900 and / or the patient's corresponding tooth. Such transfer problems can occur (e.g., simultaneously) in one or more directions (e.g., mesial, distal, occlusal, gingival, buccal, and / or lingual directions) and / or around one or more axes (e.g., mesial-distal axes, occlusal-gingival axes, and / or buccal-lingual axes). For example, the free clearance between the attachment portion 2940 and the fixation member 2900 allows the attachment portion 2940 to rotate relative to the fixation member 2900 about the mesial-distal axis, the occlusal gingival axis, and / or the buccal-lingual axis. As a result, due to the clearance between the attachment portion 2940 and the corresponding fixation member 2900, this rotation will not transfer to the corresponding tooth.

[0565] Embodiments of this technology can mitigate the problem associated with free clearance between the attachment portion and the fixation member by considering free clearance when designing orthodontic devices (as referenced). Figures 28A to 29C (as stated above). Figure 30 This is a flowchart of a method 3000 for generating design parameters and / or manufacturing orthodontic appliances or related fixtures according to embodiments of the present technology. Method 3000 includes obtaining data corresponding to the patient's OTA (process section 3002) and obtaining data corresponding to the patient's first FTA (process section 3004). As described elsewhere herein, the OTA may be based on scans of the patient's teeth, and the FTA may be determined and / or provided by an operator based on the OTA and the desired optimal positioning of the teeth.

[0566] Method 3000 may further include determining data corresponding to the second FTA (different from the first FTA) based in part on the expected free clearance between the attachment portion and the corresponding fixation member of the orthodontic appliance (process section 3006). In some embodiments, the expected free clearance may be a predetermined parameter (e.g., based on the attachment portion and fixation member used) because the expected free clearance is known or can be determined before manufacturing the orthodontic appliance. In some embodiments, the desired free clearance may correspond to a size or angle that causes modification of the design (e.g., shape, thickness, spring type, etc.) of the orthodontic appliance or its portions (e.g., arms, offset portions, attachment portions, etc.). For example, if the expected free clearance between the attachment portion and the fixation member is 15° in a first direction (e.g., the direction about the mesiodistal axis, the occlusal gingival axis, and / or the buccolingual axis), and the total rotation required for a particular tooth in the first direction (e.g., from the OTA to the first FTA) is 45°, then the arm of the orthodontic appliance (e.g., the attachment portion) may be designed to rotate 60° in the first direction. In doing so, when connected to the corresponding tooth via the corresponding fixation member, the arm or attachment portion will rotate 15° relative to the corresponding fixation member, and then rotate 45° together with the corresponding fixation member and the corresponding tooth as needed. As previously mentioned, for a single arm, the free clearance can be adjusted simultaneously in multiple directions and / or around multiple axes. Additionally or alternatively, the free clearance of each arm of the appliance can be adjusted uniquely relative to the other arms.

[0567] In some embodiments, method 3000 may omit process portion 3006 and include only a single FTA taking into account the expected free clearance. In such an embodiment, method 3000 may include receiving first data corresponding to the patient's OTA and providing second data corresponding to the patient's FTA, wherein the second data is at least partially based on the expected free clearance between the attachment portion of the orthodontic appliance and the corresponding fixation member or a portion thereof.

[0568] In some embodiments, method 3000 may further include manufacturing the jig and / or orthodontic appliance based at least on data corresponding to the second FTA. Such manufacturing of the jig and / or orthodontic appliance may correspond to a manufacturing process described elsewhere herein.

[0569] B. Consideration of the material properties of orthodontic appliances

[0570] The orthodontic appliance of this technology is configured to move a patient's teeth from the OTA (Over-The-Air) along a path to a determined optimal FTA (Free-Toothed Area). As previously described, the appliance can be manufactured with a configuration that typically corresponds to the FTA of the patient's teeth in its unloaded or stress-free state. The appliance is implanted in the patient's mouth, and the individual arms of the appliance are coupled to corresponding fixation members attached to the patient's teeth. When the individual arms are coupled to the corresponding fixation members on the patient's teeth in the OTA, the appliance is in a loaded or stressed configuration. In this loaded configuration, the appliance is typically under its maximum stress state and is therefore most likely to undergo plastic deformation, if possible. If plastic deformation occurs, a single arm may not transition from the OTA to the FTA along the desired path, and / or may not be able to provide the necessary force on the corresponding tooth. More generally, plastic deformation will limit the therapeutic effect on the patient's teeth and prevent or inhibit the teeth from reaching the FTA.

[0571] Embodiments of this technology can mitigate these problems by taking into account, or more specifically avoiding, plastic deformation when designing orthodontic appliances and / or clamps. As previously described, embodiments of this technology can determine the path of a patient's teeth from the OTA to the FTA. Thus, the path of the appliance from a first configuration typically corresponding to the OTA to a second configuration typically corresponding to the FTA is also known. Based on the expected paths of the individual arms of the appliance and one or more materials used to form the appliance (e.g., arms, offset portions, attachment portions, etc.), embodiments of this technology can determine, and if necessary, avoid, the yield strength of the appliance (at which each arm undergoes plastic deformation). For example, embodiments of this technology can be able to simulate the stresses that the individual arms of the appliance will experience when in a first configuration typically corresponding to the OTA or any other configuration between the OTA and the FTA. If the stress experienced by one arm in any such configuration is expected to exceed the yield strength of the material of that arm, embodiments of this technology can adjust one or more parameters of that arm to not exceed the yield strength. In some embodiments, altering one or more parameters of the arm may include changing the shape, configuration, and / or dimensions (e.g., length, width, and / or thickness) of any part of the orthodontic appliance (e.g., anchors, arm, and / or bias portion). Changing one or more of these parameters can increase the yield strength of the arm to a level greater than the maximum stress expected to be experienced. As an example only, some bias portions (e.g., spring design) may experience greater stress than others. Therefore, if it is determined that movement of the arm from the OTA to the FTA causes the yield strength of the arm to be exceeded, embodiments of this technology may modify the bias portion of the arm to increase its yield strength, thereby preventing plastic deformation.

[0572] Additionally or alternatively, in response to determining that altering a portion of the orthodontic appliance might exceed the yield strength, embodiments of this technology may alter the path of the patient's teeth from the OTA such that the path does not exceed the yield strength of the appliance. That is, if moving the patient's teeth from the OTA to the FTA along a first path would result in exceeding the yield strength, embodiments of this technology may alternatively alter the appliance, or more specifically, alter the corresponding arm of the appliance, such that the patient's teeth move from the OTA to the FTA along a second path different from the first path, which would result in not exceeding the yield strength.

[0573] Figure 31 This is a flowchart of a method 3100 for generating design parameters and / or manufacturing orthodontic appliances or related fixtures according to embodiments of the present technology. Method 3100 includes obtaining data corresponding to the patient's OTA (process section 3102) and obtaining data corresponding to the patient's FTA (process section 3104). As described elsewhere herein, the OTA can be based on scans of the patient's teeth, and the FTA can be determined and / or provided by an operator based on the OTA and the desired positioning of the teeth.

[0574] Method 3100 may further include determining whether the orthodontic appliance is expected to exceed a predetermined threshold associated with yield strength (process portion 3106). In some embodiments, process portion 3106 may include determining whether an orthodontic appliance configured to transition from a first configuration (e.g., corresponding to OTA) to a second configuration (e.g., corresponding to FTA) is expected to exceed the yield strength of the appliance. Additionally or alternatively, determining whether the orthodontic appliance is expected to exceed the yield strength may include determining whether any portion of the orthodontic appliance (e.g., a single arm, offset portion, attachment portion, etc.) is expected to exceed the yield strength. Thus, embodiments of the present technology can determine the stress experienced by the orthodontic appliance or any portion thereof when in a first configuration (e.g., at OTA), a second configuration (e.g., at FTA), and / or at multiple discrete points along the path between the first and second configurations (e.g., at intermediate dentition (ITA)).

[0575] In some embodiments, determining whether an orthodontic appliance is expected to exceed its yield strength can be based on, for example, the hysteresis behavior of the materials(s) forming the appliance. For the purposes of this art, hysteresis can alter the path taken by the arm of the appliance, depending on whether the arm experiences compression or tension along its path from the OTA to the FTA. For example, an arm comprising nitinol or a nitinol alloy may follow a different stress-strain curve under compression than under tension. Therefore, additionally or alternatively, the expected stress of the appliance or any portion thereof is determined at discrete points between the OTA and FTA, embodiments of this art considering the configuration of the appliance or any portion thereof before the appliance exhibits these discrete points.

[0576] In some embodiments, method 3100 may include modifying the orthodontic appliance to prevent the yield strength from being exceeded if the appliance is expected to exceed a predetermined threshold (process portion 3108). Modifying the appliance in this manner may include changing (i) the shape, configuration, and / or dimensions (e.g., length, width, and / or thickness) of the appliance (e.g., anchors, arms, and / or bias portions), and / or (ii) the material of the arms. Changing one or more of these parameters may increase the yield strength of the arms to greater than the highest stress expected to be experienced, thereby ensuring that the appliance (or any portion thereof) does not plastically deform in a way that limits the effectiveness of the patient's dental treatment. As an example, if it is determined that the appliance will exceed a predetermined threshold, a single bias portion of the appliance (e.g., a spring) may be replaced with two or more lower-load bias portions. This replacement may be performed on each arm of the appliance expected to exceed the predetermined threshold.

[0577] In some embodiments, method 3100 may further include manufacturing the clamps and / or orthodontic appliances. Such manufacturing of the clamps and / or orthodontic appliances may correspond to the manufacturing processes described elsewhere herein.

[0578] C Considerations for manufacturing irregularities

[0579] As previously described, a 3D configuration of an orthodontic appliance can be created by bending the substantially planar configuration of the appliance to present a 3D configuration typically corresponding to an FTA. In some embodiments, as described elsewhere herein, this bending is achieved by attaching (e.g., via ligatures) the substantially planar configuration of the appliance to a heat-treated clamp (possibly with slight modifications, as previously described) that typically corresponds to an FTA, and then heat-treating the substantially planar configuration such that the appliance presents and remains in the 3D configuration after heat treatment. In some embodiments, the appliance is at least partially made of a hyperelastic material (e.g., nitinol). In such embodiments, the heat treatment process described previously can be relatively mild to ensure that the hyperelastic material substantially retains its elastic properties after heat treatment. However, as a result of this mild heat treatment, after the heat treatment process is completed and the appliance is separated from the clamp, the appliance or portions thereof in the 3D configuration may tend to partially retract toward the previous substantially planar configuration. For example, after heat treatment and removal of the appliance from the clamp, the individual arms of the appliance in a 3D configuration can move along directions (e.g., labial, buccal, gingival, occlusal, mesial, and / or distal) or around axes (e.g., mesial-distal axes, occlusal-gingival axes, and / or buccal-lingual axes). As a result, the heat-treated 3D configuration of the appliance may not precisely correspond to the shape of the clamp (or more generally, the FTA). This discrepancy may cause the individual arms of the appliance to exert forces (e.g., direction and / or magnitude) different from the expected forces, thus preventing the patient's teeth from achieving the desired FTA.

[0580] Figure 32 This is a side perspective view of an orthodontic appliance 100 according to an embodiment of the present technology, and is intended to further illustrate the issue of appliance retraction after heat treatment. For illustrative purposes, only a single arm 130 of the appliance 100 is shown, but those skilled in the art will understand that the principles described herein can be applied to any arm 130 of the appliance (e.g., Figure 16 The orthodontic appliance 100 shown is an example. Figure 32 As shown, arm 130 is along axis (A) FTA This axis extends to correspond to the FTA of the patient's teeth. As previously mentioned, at least in part due to the material of the appliance, when the appliance is heat-treated on the clamp and removed from the clamp, the appliance tends to retract to its previous position outside the FTA. Figure 32 As shown, axis (A) R ) corresponds to the orthodontic appliance in, for example, from the axis (A) FTA After retraction, it will have the following arrangement. That is, if the clamp is on arm 130 along axis A FTA If the orthodontic arm 130 is heat-set while being positioned, it will then retract along the axis (A). R Positioning, this axis is offset from its heat-set axis (A) FTA ) and / or deflection toward a more planar configuration. Such arms or appliances are typically aligned with the axis (A FTA The teeth are spaced apart, so when connected to a fixed member that adheres to the patient's teeth, it will provide a different force than expected, thus preventing the patient's teeth from reaching the FTA.

[0581] Embodiments of this technology can mitigate this problem by considering the material properties of the orthodontic appliance and / or clamp when designing it, and more generally by considering the manufacturing process. For example, embodiments of this technology can design / manufacture appliances with a configuration that retracts after heat treatment, thus having a configuration that substantially corresponds to the FTA. Figure 32 As shown, axis (A) F This corresponds to the arrangement of the clamps and / or orthodontic appliances after heat treatment and before removal from the clamps. After heat treatment and separation from the clamps, the arms 130 of the orthodontic appliance 100 can generally be removed from the axis (A). F ) Retract back to axis (A) FTA ), which corresponds to the FTA of the patient's teeth. Therefore, the axis (A) F This can correspond to a position whereby the arm 130 of the appliance 100 can have an alignment corresponding to the FTA of the corresponding tooth after the appliance has been heat-treated, while maintaining the desired elastic properties of the material, for example, to reposition the patient's teeth to the FTA. In other words, if the clamp is designed to have an alignment with the axis (A)F The corresponding arrangement, after the expected retraction, the final orthodontic appliance formed by the clamps can have an alignment with the axis (A). FTA Corresponding to or along axis (A) FTA The arrangement is positioned. In some embodiments, from axis (A) F ) to axis (A) FTA The amount of retraction can be related to the amount of retraction from the axis (A). FA ) to axis (A) R The retraction amount may be the same or different. Therefore, this variation in retraction amount can be taken into account during the manufacturing process, such as when designing fixtures.

[0582] Figure 33 This is a flowchart of a method 3300 for generating design parameters and / or manufacturing orthodontic appliances or related fixtures according to embodiments of the present technology. Method 3300 includes obtaining OTA data corresponding to a patient (process section 3302) and obtaining first FTA data corresponding to the patient (process section 3304). As described elsewhere herein, the OTA may be based on scans of the patient's teeth, and the FTA may be determined and / or provided by an operator based on the OTA and the desired positioning of the teeth.

[0583] Method 3300 may further include determining data corresponding to the second FTA (different from the first FTA) based on anticipated variations in the orthodontic appliance associated with the manufacturing apparatus (process section 3306). The anticipated variations may correspond to different anticipated positions or arrangements of the retracted orthodontic appliance relative to the FTA after heat treatment (as previously described). For example, if the position of a particular arm of the retracted orthodontic appliance is spaced apart from the position of a corresponding arm in the FTA (e.g., in the lingual, occlusal, and / or distal directions), the anticipated variations, and the data corresponding to the second FTA therein, may correspond to the positional difference between the arm in the retracted position and the arm in the second FTA position. The anticipated variations may be predetermined parameters, as they are known or can be determined prior to appliance manufacturing. In some embodiments, the desired change may be based on one or more factors, including (i) the shape, configuration, and / or size (e.g., length, width, and / or thickness) of the appliance (e.g., anchors, arms, and / or offset portions), (ii) the (multiple) materials of the appliance, (iii) the type of heat treatment applied or expected to be applied (e.g., maximum temperature of the heat treatment, elapsed time of the heat treatment, etc.), and / or (iv) other aspects of the particular patient's dentition. In some embodiments, the desired change may be unique for each arm of the appliance. Thus, the desired change may correspond to different values ​​or modifications made to each arm (e.g., each offset portion, attachment portion, etc.).

[0584] In some embodiments, method 3300 may omit process portion 3306 and include only a single FTA that takes into account anticipated changes in the orthodontic appliance. In such an embodiment, method 3300 may include receiving first data corresponding to the patient's OTA and providing second data corresponding to the patient's FTA, wherein, as described above, the second data is partially based on anticipated changes in the orthodontic appliance or clamp associated with manufacturing.

[0585] In some embodiments, method 3300 may further include manufacturing the jig and / or orthodontic appliance based at least on data corresponding to the second FTA. Such manufacturing of the jig and / or orthodontic appliance may correspond to a manufacturing process described elsewhere herein.

[0586] D、 Considerations for expected tooth movement after repositioning

[0587] The appliances in this technique are configured to reposition the patient's teeth from the OTA (Over-The-Air) along a path leading to a determined optimal FTA (Free-Toothed Area). After reaching the FTA, the patient's teeth may experience orthodontic relapse and move towards their previous position (e.g., the OTA), thus moving away from their optimal position. For example, after teeth are repositioned to the FTA via appliances, the patient's teeth may typically move partially in the buccal direction and / or partially in the occlusal direction. Therefore, the patient's teeth may no longer resemble the FTA after relapse. Retainers or other devices can be used to prevent this relapse, but these devices are often ineffective for various reasons (e.g., lack of patient compliance).

[0588] Embodiments of this technology can mitigate these problems by taking orthodontic relapse into account when designing orthodontic appliances and / or clamps. As previously described, the 3D configuration of an orthodontic appliance can be created by bending the substantially planar configuration of the appliance to present a 3D configuration that typically corresponds to the FTA. In some embodiments, this bending is achieved by attaching the substantially planar configuration of the appliance to a clamp (with slight modifications, as previously described) that generally corresponds to the FTA, and then heat-treating the substantially planar configuration so that the appliance presents and remains in the 3D configuration. To account for orthodontic relapse after repositioning a patient's teeth to the FTA, embodiments of this technology can determine the expected amount of relapse and modify the design of the appliance and / or clamp accordingly.

[0589] Figure 34This is a flowchart of a method 3400 for generating design parameters and / or manufacturing orthodontic appliances or related fixtures according to embodiments of the present technology. Method 3400 includes obtaining data corresponding to the patient's OTA (process section 3402) and obtaining data corresponding to the patient's first FTA (process section 3404). As described elsewhere herein, the OTA may be based on scans of the patient's teeth, and the FTA may be determined and / or provided by an operator based on the OTA and the desired optimal positioning of the teeth.

[0590] Method 3400 may further include determining data corresponding to the second FTA (different from the first FTA) based in part on the expected relapse of the patient's teeth after repositioning (e.g., to the first FTA and / or the second FTA) (process section 3406). The second FTA may correspond to a tooth alignment where the expected relapse causes the patient's teeth to transition from the second FTA to the first FTA, which is the patient's optimal tooth alignment. Thus, in some embodiments, an appliance having a configuration substantially corresponding to the second FTA may have a single arm whose position is spaced apart in a particular direction (e.g., labial, buccal, gingival, occlusal, mesial, and / or distal) and / or around a particular axis (e.g., mesial-distal, occlusal-gingival, and / or buccal-lingual) from the position of the corresponding single arm of the appliance having a configuration substantially corresponding to the first FTA.

[0591] In some embodiments, the expected relapse can be a predetermined parameter because the expected relapse is known or can be determined before manufacturing the appliance and / or clamps. Determining the expected relapse can be based on a second FTA, a first FTA, an OTA, and / or other patient-dental-specific factors. Additionally or alternatively, the expected relapse for each tooth may differ. For example, smaller teeth (e.g., incisors) may experience more relapse than larger teeth (e.g., molars). Thus, the various parts of the appliance (e.g., anchors, arms, offset portions, attachment portions, etc.) and / or the clamps corresponding to each tooth can be adjusted differently and individually based on the expected relapse of that particular part. For example, modifications made to smaller teeth expected to experience more relapse may be smaller than modifications made to larger teeth expected to experience less relapse.

[0592] In some embodiments, method 3400 may omit process portion 3406 and include only a single FTA considering the expected relapse of the orthodontic appliance. In such an embodiment, method 3400 may include receiving first data corresponding to the patient's OTA and providing second data corresponding to the patient's FTA, wherein the second data is partially based on the expected relapse of the patient's teeth after repositioning.

[0593] In some embodiments, method 3400 may further include manufacturing the jig and / or orthodontic appliance based at least on data corresponding to the second FTA. Such manufacturing of the jig and / or orthodontic appliance may correspond to a manufacturing process described elsewhere herein.

[0594] Any process described in detail herein can be used in conjunction with any other process detailed herein. For example, regarding Figures 19-25 Any process described can be related to... Figures 26-34 Use any of the described processes together.

[0595] in conclusion

[0596] While many embodiments of orthodontic appliances positioned primarily on the lingual side of a patient's teeth have been described above, this technology can be applied to other applications and / or other methods, such as orthodontic appliances positioned on the facial side of a patient's teeth. Furthermore, other embodiments besides those described herein are also within the scope of this technology. Additionally, several other embodiments of this technology may have different configurations, components, or processes than those described herein. Therefore, those skilled in the art will accordingly understand that this technology may include other embodiments with additional elements, or that the technology may be implemented without the foregoing reference. Figures 1A to 34 Other embodiments exist for the several features shown and described.

[0597] The description of embodiments of this technology is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Singular or plural terms may also include plural or singular terms, respectively, where the context permits. For example, embodiments described herein using multiple connecting arms may be modified to include fewer (e.g., one) or more (e.g., three) connecting arms. Although specific embodiments and examples of this technology have been described above for illustrative purposes, various equivalent modifications can be made within the scope of this technology, as will be recognized by those skilled in the art. For example, while 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.

[0598] Furthermore, unless the word “or” is explicitly limited to referring to only a single item and excluding other items in a list of two or more items, its use 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. Additionally, the term “comprising” throughout means including at least one or more of the listed features, without excluding any further number of the same features and / or other features of additional types. It will also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the art. Furthermore, while advantages associated with certain embodiments of the art have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments must exhibit such advantages to fall within the scope of the art. Therefore, this disclosure and related art may include other embodiments not explicitly shown or described herein.

Claims

1. A method for designing an orthodontic appliance for repositioning a patient's teeth, the method comprising: A digital model of an orthodontic appliance is obtained, the digital model representing an orthodontic appliance in a pre-installed configuration, the digital model having an anchor portion and an arm, the anchor portion being configured to be positioned on the patient's gums, and the arm being configured to be attached to the patient's teeth. Obtain an anatomical digital model that represents the patient's teeth and gums in their original arrangement; Perform FEA to virtually deform the orthodontic appliance digital model into a shape based on the anatomical digital model, wherein the deformed orthodontic appliance digital model virtually represents the orthodontic appliance mounted on the patient's teeth in the original alignment; and Evaluating a deformed digital model of an orthodontic appliance, wherein the evaluation of the deformed digital model of the orthodontic appliance includes determining whether the deformed digital model of the orthodontic appliance impacts the gingiva or is spaced from the gingiva in a manner greater than a predetermined threshold.

2. The method of claim 1, wherein the orthodontic appliance includes an anchor and an arm extending away from the anchor, the arm including a proximal portion at the anchor and a distal portion configured to be fixed to an orthodontic bracket, and wherein performing FEA includes positioning the distal portion of the arm at or near a tooth of the patient.

3. The method of claim 1, wherein the orthodontic appliance has a basic three-dimensional (3D) shape in the pre-installed configuration.

4. The method of claim 1, wherein evaluating the configuration of the deformation includes determining whether any portion of the deformed digital model of the orthodontic appliance exceeds the elastic strain limit.

5. The method of claim 1, wherein evaluating the deformed configuration includes determining the difference between the force and / or torque applied to the teeth by the deformed appliance and the expected force and / or torque.

6. The method of claim 1, further comprising modifying the digital model of the orthodontic appliance based on the evaluation, wherein modifying the digital model of the orthodontic appliance includes changing at least one of the shape of the arm of the orthodontic appliance, the shape of the anchor of the orthodontic appliance, or the shape of the orthodontic appliance in the pre-installed configuration.

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