Teeth repositioning systems and methods

Abstract

To provide teeth repositioning systems and methods.SOLUTION: Systems and methods of repositioning teeth, using one or more appliances for placement on a patient's teeth are described. The appliance includes: an arch-shaped member; a plurality of spring members coupled to or provided on the arch-shaped member; and a plurality of securement members to be secured to a corresponding plurality of the patient's teeth on a one-to-one basis, the securement members being supported by the arch-shaped member. The arch-shaped member and the plurality of springs together comprise a two-dimensional structure, which has a length dimension and a width dimension with widths varying along the length dimension and is bent into a three-dimensional structure.SELECTED DRAWING: Figure 18f

Description

[Technical Field]

[0001] <Cross-reference to related patent applications> This application claims priority from U.S. Provisional Application No. 62 / 263,659, filed December 6, 2015, U.S. Provisional Application No. 62 / 352,025, filed June 20, 2016, and U.S. Provisional Application No. 62 / 393,526, filed September 12, 2016, each of which is incorporated herein by reference in its entirety.

[0002] Embodiments of the present invention generally relate to systems and methods for repositioning teeth, including orthodontic systems and methods that include or use one or more appliances placed (removable or non-removable) on a patient's teeth. [Background technology]

[0003] In the field of orthodontics, repositioning teeth for aesthetic or other purposes has traditionally been accomplished with orthodontic devices called braces. Braces typically consist of brackets, archwires, O-rings, and ligatures. In addition to braces, which typically have visible appliances in front of the teeth, other methods include lingual orthodontics (which use appliances behind the teeth) and clear aligners, such as Invisalign® aligners (which use clear polymer shells over the teeth). Summary of the Invention [Means for solving the problem]

[0004] Embodiments described herein relate to systems and methods for repositioning teeth that include or use one or more appliances placed (removably or non-removably) on the patient's teeth.

[0005] According to various example embodiments, an appliance for placement on a patient's teeth includes an arch-shaped member, a plurality of spring members coupled to or carried by the arch-shaped member, and a plurality of anchoring members for anchoring to a plurality of the patient's teeth, the anchoring members being carried by the arch-shaped member. In such examples, the arch-shaped member and the plurality of springs are both two-dimensional structures having a length dimension and a width dimension that varies along the length dimension and are bent into a three-dimensional structure.

[0006] In a further embodiment of the device, each fixation member comprises: (a) a respective separate male connector element configured to engage with one or more respective separate female connector elements attached to one or more of the patient's teeth; and (b) a respective separate cap configured to be fitted and secured over one or more of the patient's teeth.

[0007] In a further embodiment of the appliance, the arch-shaped members are configured to extend correspondingly along the arch of the patient's jaw when the appliance is placed over the patient's teeth, and each spring member is positioned along the arch-shaped member at a position between two teeth of the patient's jaw as the arch-shaped member extends along the patient's jaw.

[0008] Further exemplary embodiments of the appliance include a plurality of arms extending from the arch-shaped member, each arm corresponding to one or more of the patient's teeth, and each of the plurality of anchoring members attached to at least a different respective arm relative to each of the other anchoring members. In these examples, each anchoring member includes either (a) a respective male connector element configured to engage with one or more respective female connector elements bonded to one or more of the patient's teeth, or (b) a respective cap configured to be fitted and secured to one or more of the patient's teeth.

[0009] In a further embodiment of the device, each spring member of the plurality of spring members is disposed along a different respective arm relative to each other spring member.

[0010] In a further embodiment of the device, each spring member is provided on a respective arm at a location between the arched member and a fixed member attached to the arm.

[0011] In a further embodiment of the device, each locking member is separate from and does not cover any portion of the spring member of the arm to which it is attached.

[0012] In a further embodiment of the appliance, each fixation member includes a respective separate cap configured to be fitted and secured over one or more of the patient's teeth when the appliance is in place, and the plurality of fixation members includes a plurality of caps arranged along the arch-shaped member, each respective separate cap being separate from one or more other caps of the plurality of caps.

[0013] In a further embodiment of the appliance, each fixation member comprises a T-shaped member configured to interface with one of the patient's teeth and engage with a slot in the female connector element.

[0014] According to a further example embodiment, an appliance for placement on a patient's teeth includes an arch-shaped member, a plurality of arms extending from the arch-shaped member, each arm corresponding to one or more different individual teeth of the patient's teeth relative to a respective other arm of the plurality of arms, and a plurality of fixing members for fixing to the patient's plurality of teeth, each fixing member of the plurality of fixing members attached to one or more arms.

[0015] In a device according to a further example of the above embodiment, each of the plurality of fixation members is attached to a different respective arm relative to other fixation members of the plurality of fixation members.

[0016] In a device according to a further example of the above embodiment, each fixation member comprises: (a) a respective male connector element configured to engage with one or more respective female connector elements attached to one or more of the patient's teeth; or (b) a respective cap configured to be fitted and secured over one or more of the patient's teeth.

[0017] An apparatus according to a further example of the above-described embodiment includes a plurality of spring members coupled to or provided on one or more of the plurality of arms, wherein one or more of the arms includes at least one spring member.

[0018] In a device according to a further example of the above embodiment, each spring member is provided on a respective arm at a location between the arched member and a fixed member attached to the arm.

[0019] In a device according to a further example of the above embodiment, each locking member is separate from and does not cover any portion of the spring member of the arm to which it is attached.

[0020] In an appliance according to a further example of the above embodiment, each fixing member includes a respective separate cap configured to fit snugly over and be secured to one or more of the patient's teeth when the appliance is in place, and the plurality of fixing members includes a plurality of caps arranged along an arch formed by the arch-shaped members, each respective separate cap being separate from one or more other caps of the plurality of caps.

[0021] According to an example embodiment, a method of fabricating an appliance for placement on a patient's teeth includes cutting a flat sheet of material into a two-dimensional structure having length and width dimensions and a thickness corresponding to the thickness of the sheet of material; bending the two-dimensional structure into a three-dimensional structure having an arch-shaped member and a plurality of spring members coupled to or disposed on the arch-shaped member; and supporting a plurality of fixation members on the arch-shaped member for fixation to a plurality of the patient's teeth.

[0022] In a further embodiment, the method comprises each fixation member comprising: (a) a respective separate male connector element configured to engage with one or more respective female connector elements attached to one or more of the patient's teeth; or (b) a respective separate cap configured to be fitted and secured over one or more of the patient's teeth.

[0023] In a further embodiment of the method, the arch-shaped member is configured to extend correspondingly along the arch of the patient's jaw when the appliance is placed over the patient's teeth, and each spring member is positioned along the arch-shaped member at a position between two teeth of the patient's jaw as the arch-shaped member extends along the patient's jaw.

[0024] In a further embodiment of the method, the cutting further comprises cutting the flat sheet material to form a plurality of arms extending from the arch-shaped member and each arm corresponding to one or more of the patient's teeth, and the supporting the plurality of anchoring members includes providing each anchoring member of the plurality of anchoring members on one or a combination of arms that are different from each other anchoring member.

[0025] In a further embodiment of the method, each fixation member comprises: (a) a respective separate male connector element configured to engage with one or more respective female connector elements attached to one or more of the patient's teeth; or (b) a respective separate cap configured to be fitted and secured over one or more of the patient's teeth.

[0026] In a further embodiment of the method, individual spring members of the plurality of spring members are disposed along different individual arms relative to each other spring member.

[0027] In a further embodiment of the method, each spring member is provided on a respective arm at a location between the arched member and a fixed member attached to the arm.

[0028] In a further embodiment of the method, supporting the plurality of fixed members includes supporting each fixed member in a position such that it is spaced apart from the spring member of the arm to which it is attached and does not engage any part of the spring member.

[0029] In a further embodiment of the method, supporting the plurality of fixation members includes providing separate caps configured to be snugly fitted and secured over one or more of the patient's teeth when the appliance is placed, and supporting each cap such that it is positioned along the arch member and disengages from one or more other caps of the plurality of caps.

[0030] In a further embodiment, the method of supporting the plurality of fixation members includes supporting a plurality of T-shaped members, each T-shaped member configured to interface with one of the patient's teeth and engage with a slot in the female connector element.

[0031] In a further embodiment, the method further includes obtaining a three-dimensional image or template of a desired arrangement of the patient's teeth and converting the three-dimensional image or template into a two-dimensional image or template, and cutting the flat sheet material into a two-dimensional structure includes cutting the flat sheet material into a shape corresponding to the two-dimensional image or template.

[0032] In a method according to a further embodiment, the flat sheet material comprises a sheet of Nitinol.

[0033] In a method according to a further embodiment, the flat sheet material comprises a sheet of shape memory metal.

[0034] In a method according to a further embodiment, at least one of the length dimension or width dimension of the two-dimensional structure varies across the width or length of the two-dimensional structure. [Brief explanation of the drawings]

[0035] [Figure 1] 1 is a perspective view of an example of a first embodiment of a device; FIG. [Figure 2] FIG. 10 is a perspective view of an apparatus according to another example of the first embodiment. [Figure 3] FIG. 10 is a perspective view of an apparatus according to another example of the first embodiment. [Figure 4a] 1A-1C are perspective views of springs for devices according to various examples of the first, second, third and fourth embodiments. [Figure 4b] 1A-1C are perspective views of springs for devices according to various examples of the first, second, third and fourth embodiments. [Figure 4c] 1A-1C are perspective views of springs for devices according to various examples of the first, second, third and fourth embodiments. [Figure 5] FIG. 10 is a perspective view of an apparatus according to another example of the first embodiment. [Figure 6] FIG. 10 is a perspective view of an apparatus according to another example of the first embodiment. [Figure 7] FIG. 10 is a perspective view of an upper and lower jaw with an example female connector element. [Figure 8] FIG. 10 is a perspective view of an example of a second embodiment of the device. [Figure 9] FIG. 10 is a perspective view of an apparatus according to another example of the second embodiment. [Figure 10] FIG. 10 is a perspective view of an apparatus according to another implementation of the second embodiment. [Figure 11] FIG. 10 is a perspective view of an apparatus according to another implementation of the second embodiment. [Figure 12a] FIG. 10 is a perspective view of a male connector element and arm components for an appliance according to another example of the second embodiment. [Figure 12b] FIG. 10 is a perspective view of a male connector element and arm components for an appliance according to another example of the second embodiment. [Figure 12c] FIG. 10 is a perspective view of a male connector element and arm components for an appliance according to another example of the second embodiment. [Figure 12d] FIG. 10 is a perspective view of a male connector element and arm components for an appliance according to another example of the second embodiment. [Figure 12e]Perspective view of the male connector element and arm components for an instrument according to another example of the second embodiment. [Figure 12f] Perspective view of the male connector element and arm components for an instrument according to another example of the second embodiment. [Figure 12g] Perspective view of the male connector element and arm components for an instrument according to another example of the second embodiment. [Figure 12h] Perspective view of the male connector element and arm components for an instrument according to another example of the second embodiment. [Figure 13a] Perspective view of the upper jaw with another example of the female connector element. [Figure 13b] Perspective view of the female connector element of the type of FIG. 13a. [Figure 14] Perspective view of an instrument according to another example of the second embodiment. [Figure 15a] Plan view of an example of the male connector element. [Figure 15b] Perspective view of another example of the female connector element. [Figure 15c] Perspective view of the male connector element of FIG. 15a connected to the female connector element of FIG. 15b adhered to a tooth. [Figure 16a] Front view of an example of the male connector element of the instrument. [Figure 16b] Perspective view of an example of the female connector element that can be used with the male connector element of FIG. 16a. [Figure 16c] Perspective view of the male connector element received within the female connector element according to the examples of FIGS. 16a and 16b. [Figure 17a] Perspective view of an instrument or instrument component according to another example of the first embodiment. [Figure 17b] Perspective view of the instrument of FIG. 17a installed on a tooth to which the female connector element is joined. [Figure 18a] Perspective view and plan view of a member, and a view representing the instrument in two dimensions (2D). [Figure 18b]Perspective and plan views of the components and a two-dimensional (2D) representation of the device. [Figure 18c] Perspective and plan views of the components and a two-dimensional (2D) representation of the device. [Figure 18d] Perspective and plan views of the components and a two-dimensional (2D) representation of the device. [Figure 18e] 18a to 18d and 18b are perspective views showing the components and configurations of the device according to the second embodiment. [Figure 18f] 18a to 18d and 18b are perspective views showing the components and configurations of the device according to the second embodiment. [Figure 19a] FIG. 10 is a perspective view of tools and components for making a device according to a third embodiment. [Figure 19b] FIG. 10 is a perspective view of tools and components for making a device according to a third embodiment. [Figure 19c] FIG. 19c is a perspective view of an apparatus made in accordance with FIGS. 19a-19b according to a third embodiment. [Figure 20] 1 is a flowchart of a method of fabricating a device according to various embodiments. [Figure 21] 10 is a flowchart of further steps for fabricating a device according to various embodiments. [Figure 22a] FIG. 10 is a schematic diagram of an apparatus according to a third embodiment, showing the passive state. [Figure 22b] 1 is a schematic diagram of an appliance according to a third embodiment, shown connected to a tooth and in an active state; [Figure 23a] FIG. 10 is a schematic diagram of an apparatus according to a fourth embodiment, showing the passive state. [Figure 23b] FIG. 10 is a schematic view of an appliance according to a fourth embodiment, shown connected to a tooth and in an active state. [Figure 24] FIG. 1 is a generalized schematic diagram of a processing system that can be used to implement certain example embodiments. [Figure 25] FIG. 1 is a front view of an example of a T-shaped male connector element. [Figure 26a] 26 is a perspective view showing an example of a female connector element that receives or is for receiving a T-shaped male connector element such as, but not limited to, that shown in FIG. 25. FIG. [Figure 26b] 26 is a perspective view showing an example of a female connector element that receives or is for receiving a T-shaped male connector element such as, but not limited to, that shown in FIG. 25. FIG. [Figure 26c] 26 is a perspective view showing an example of a female connector element that receives or is for receiving a T-shaped male connector element such as, but not limited to, that shown in FIG. 25. FIG. [Figure 26d] 26 is a perspective view showing an example of a female connector element that receives or is for receiving a T-shaped male connector element such as, but not limited to, that shown in FIG. 25. FIG. [Figure 26e] 26 is a perspective view showing an example of a female connector element that receives or is for receiving a T-shaped male connector element such as, but not limited to, that shown in FIG. 25. FIG. [Figure 26f] 26 is a perspective view showing an example of a female connector element that receives or is for receiving a T-shaped male connector element such as, but not limited to, that shown in FIG. 25. FIG. [Figure 27a] 1A-1C are front views showing two examples of annular male connector elements. [Figure 27b] 1A-1C are front views showing two examples of annular male connector elements. [Figure 28] FIG. 27b is a front view of the male connector element of FIG. 27a engaged with a female connector element. DETAILED DESCRIPTION OF THE INVENTION

[0036] In the following description of various embodiments, reference is made to the accompanying drawings which form a part hereof, and which show, by way of illustration, specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the various embodiments disclosed in the present disclosure.

[0037] Embodiments described herein relate to systems and methods for repositioning teeth. Certain embodiments relate to systems and methods for repositioning teeth from an original dentition (OTA) to a desired final dentition (FTA). In certain embodiments, the tooth repositioning can be accomplished in a single step by using one appliance. In other embodiments, the tooth repositioning includes multiple steps performed incrementally by using multiple appliances. Embodiments including multiple steps (or multiple appliances, or both) may include one or more intermediate dentitions (ITA) between the original dentition (OTA) and the desired final dentition (FTA).

[0038] Certain embodiments use a non-sliding mechanism that allows one or more appliances to be placed behind the teeth for patients who are concerned about appearance. Other embodiments may use other suitable mechanisms to attach one or more appliances to the back or front of the patient's teeth, or to both the back and front of the patient's teeth. The decision whether to place an appliance in the front or back of the teeth is typically made by a clinician, doctor, or other trained personnel and the patient.

[0039] Some embodiments described herein include or use fixed appliances that cannot be removed by the patient once the appliances are placed on the patient's teeth. Other embodiments described herein include or use removable appliances that can be selectively removed by the patient and placed on the patient's teeth. Embodiments that include or use fixed appliances require less patient cooperation and training or involvement compared to embodiments that include or use removable orthodontic techniques.

[0040] Certain embodiments described herein can reduce the number of patient visits to the clinician and clinician-patient seat time, and in certain embodiments can reduce overall treatment time compared to traditional orthodontic procedures.

[0041] In certain embodiments described herein, tooth movement planning can be computerized, simplifying the process for clinicians and increasing the accuracy of the process compared to conventional techniques.

[0042] One or more of the instruments and methods described herein may include or be combined with one or more bone fixation devices, including but not limited to temporary fixation devices, miniplates, implants, and the like.

[0043] A system or method according to a first embodiment includes or uses a pin and tube style instrument. Some pin and tube type instruments have been used in prior systems, such as the Begg instrument system. The instrument according to the first embodiment includes male connector elements and one or more springs positioned between adjacent male connector elements. In certain examples of the first embodiment, one or more springs are provided between each male connector element and each adjacent male connector element. In other examples of the first embodiment, one or more springs are provided between some, but not all, pairs of adjacent male connector elements. For example, a rigid portion of the instrument may be provided between one or some pairs of adjacent male connector elements. In further examples, one or more springs may be provided between male connector elements that are not directly adjacent to one another. Each spring is a force-generating element of the instrument. In certain embodiments, each spring is made of a flexible material, such as, but not limited to, a shape memory alloy, such as Nitinol. In certain embodiments, one or more springs or other portions of the appliance (or the entire appliance) are fabricated from a flat sheet of flexible material, such as, but not limited to, a shape memory alloy like Nitinol, cut to the desired two-dimensional shape, and then bent into the desired three-dimensional shape of the appliance. In such embodiments, the two-dimensional shape may be configured with a desired width and length, which can provide additional design options compared to traditional bent wire appliance systems in which a single diameter wire is bent and set to the desired shape. In certain embodiments, computerized design and manufacturing can be used to design or configure the two-dimensional shape and / or bend the two-dimensional shape into the three-dimensional shape of the appliance. In certain examples, computerized design techniques are used to design each spring, and the design takes into account which teeth are to be moved and the desired amount and direction of tooth movement.

[0044] In a first embodiment, the male connector element is configured to mate with a female connector element or bracket attached to a tooth surface. The female connector element or bracket can be customized in size and / or shape for each tooth or each patient (or both). Alternatively, the female connector element or bracket can be configured to fit any patient or tooth (or group of patients or teeth) and need not be customized for each tooth or patient. Any suitable female connector element configured to engage and secure with a male connector element on an appliance may be used in the various embodiments described herein, including, but not limited to, the examples of female connector elements described herein, including traditional twin brackets, self-ligating brackets, etc.

[0045] A system or method according to an example of the second embodiment includes or uses an appliance having multiple separate arms configured to connect to a corresponding plurality of the patient's teeth, with each arm of the appliance configured to connect to a different individual tooth relative to each of the other arms of the appliance. In further examples of the second embodiment, the appliance described herein may include one arm configured to connect to multiple teeth, or multiple separate arms configured to connect to corresponding ones of the patient's teeth, or various combinations of arm-to-tooth connections. In such examples of the second embodiment, the appliance includes a single rigid bar to which each of the separate arms is attached. In other examples, the appliance includes two or more rigid bars, with one or more arms attached to each rigid bar. One or more (or each) arms may include one or more springs. In certain examples, computer-aided design techniques can be used to design each arm (or each spring, or both), taking into account which teeth are to be moved, as well as the desired amount and direction of tooth movement.

[0046] In the device according to the second embodiment, a separate male connector element may be formed on or attached to each arm, for example, at the end of each arm opposite the end attached to the rigid bar, and each male connector element may be configured to engage a respective female connector element or bracket.

[0047] As with the first embodiment described above, the female connector element or bracket of the second embodiment can be customized in size and / or shape for each tooth or for each patient (or both). Alternatively, the female connector element or bracket may be configured for application to any patient or tooth (or group of patients or teeth) and may not be customized for each tooth or patient. Unlike certain conventional orthodontic techniques in which all of the teeth are connected to a single archwire, where moving one tooth can cause unintended movement of nearby teeth, certain embodiments described herein allow the clinician to control the movement of each tooth separately from other individual teeth.

[0048] In certain examples of the first and second embodiments, the female connector element is configured as a twin bracket (e.g., having a vertical slot and a lateral, horizontal slot) into which the male connector element locks, and the male connector element is configured as a T-shaped structure or wire that can engage slots in the twin bracket. After engagement, the T-shaped structure of the male connector element may be secured to the twin bracket by one or more ligatures, O-rings, or other suitable securing mechanisms, for example, while the clinician is placing the appliance on the patient's teeth. In other examples, the female connector element is configured as a self-ligating bracket that can "close" the T-arms and securely hold them together, with or without additional securing mechanisms. In other examples, the female and male connector elements have other suitable configurations that allow for selective connection and disconnection of the elements, with or without additional securing mechanisms, as described above.

[0049] A system or method according to a third embodiment has a configuration similar to that of the first embodiment, but includes or uses a selectively removable appliance, allowing a patient (or clinician) to selectively place and remove the appliance from the patient's teeth. The appliance according to the third embodiment includes multiple aligner caps instead of the male connector elements described above. Each aligner cap is configured to be secured to a respective tooth by fitting over the tooth. In other examples, one or more aligner caps may be configured to secure a group of teeth together. For example, the aligner caps may include caps made of other suitable materials or acrylic caps, such as materials that help retain each cap on the patient's teeth. In certain embodiments, additional or alternative connector elements, such as clasps or other attachment mechanisms, may be provided to aid in the attachment of one or more (or each) of the caps to their respective teeth.

[0050] The appliance according to the third embodiment may include one or more springs between adjacent aligner caps. In some examples of the third embodiment, one or more springs are provided between each aligner and each adjacent aligner cap. In other examples of the third embodiment, one or more springs are provided between some, but not all, pairs of adjacent aligner caps. For example, a rigid portion of the appliance may be provided between one or more pairs of adjacent aligner caps. In further examples, one or more springs may be provided between aligner caps that are not directly adjacent to each other. Each spring is a force-generating element of the appliance. In certain embodiments, each spring is made of a flexible material, such as, but not limited to, a shape memory alloy, such as Nitinol.

[0051] In the third embodiment, each cap can be customized to a size and / or shape corresponding to the size and shape of the tooth (or teeth) it will fit. Alternatively, the aligner caps can be configured to be applied to any patient or tooth (or group of patients or teeth) and are not customized for each tooth or patient. In some implementations of the third embodiment, each aligner cap may be separately connected to the support bar and not directly connected to any other caps for adjacent teeth. In other examples, one or more aligner caps can be connected to one or two adjacent aligner caps, such that two or more aligner caps are connected together along the arch-shaped structure of the support bar. This provides flexibility to the appliance according to the third embodiment, allowing the clinician to complete treatment with fewer appliances. In certain examples, each cap corresponds to (is configured to be secured to) a single, respective tooth and is separately attached to the support bar relative to the other caps of the appliance, such that multiple separate caps are secured to multiple separate teeth in one-to-one correspondence. In another example, one or more caps of the appliance are configured to cover and fit (secure) multiple adjacent teeth. Such one or more caps configured for securing to a plurality of adjacent teeth may be separately attached to a support bar that is separate from one or more other adjacent caps of the appliance.

[0052] A system or method according to the fourth embodiment includes or uses an appliance having a configuration similar to that of the second embodiment, but is further configured to be selectively removable, allowing a patient (or clinician) to selectively place and remove the appliance from the patient's teeth. Like the second embodiment, an example appliance according to the fourth embodiment has multiple separate arms configured to connect individually to a corresponding number of teeth, with each arm of the appliance configured to connect to a different individual tooth relative to the other arms of the appliance. In further examples of the fourth embodiment, the appliance described herein may include one arm configured to connect to multiple teeth, or multiple separate arms configured to connect to corresponding ones of the patient's teeth, or various combinations of arm-to-tooth connections. The appliance includes a single rigid bar to which each individual arm is attached. In other embodiments, the appliance includes two or more rigid bars, each with one or more arms attached to the rigid bar.

[0053] Instead of the male connector elements of the second embodiment, the appliance according to the fourth embodiment includes separate aligner caps formed or attached to the ends of each arm, e.g., opposite the ends attached to the rigid bar. The aligner caps of the fourth embodiment can be configured similarly to the aligner caps described herein for the third embodiment, and can be secured to the patient's teeth by fitting over and over the teeth. However, the separate aligner caps of the fourth embodiment are attached to the ends of each separate arm.

[0054] Systems or methods according to the second and fourth embodiments (wherein the appliance includes multiple separate arms configured to individually connect to a designated tooth or corresponding teeth) can provide the distinct advantage of providing and controlling individual tooth movement. Such advantages allow clinicians to limit tooth relapse, thereby reducing treatment time, root resorption, and the number of visits a patient must make to the orthodontist. Thus, compared to traditional orthodontic techniques in which multiple teeth are connected to a single archwire, where moving one tooth can potentially cause unintended movement of nearby teeth, certain embodiments described herein allow clinicians to control the movement of each tooth independently of each of the other teeth. Additional control may be provided in embodiments in which the appliance includes a temporary anchorage device (TAD) holder, as described herein.

[0055] Systems or methods according to the third and fourth embodiments (wherein the appliance includes a plurality of aligner caps configured to be secured to the patient's teeth by fitting over the teeth) can provide the distinct advantage of appliances that can be easily removed by the patient or clinician in a manner similar to that performed with conventional clear aligners.

[0056] Additionally, embodiments described herein allow for computerized design and fabrication, e.g., designing or customizing various aspects of one or more appliances, such as designing or customizing one or more of the appliance's width, thickness, shape, spring tension, or strength of each spring within the appliance. Computerized design and fabrication techniques can be used to design and / or fabricate each spring in an appliance according to any of the embodiments, or each arm in an appliance according to the second and fourth embodiments, based on which a tooth or teeth move a desired amount and direction of movement. In certain embodiments, the computerized shapes and features of the appliances described herein and / or fabrication techniques can provide significant advantages over traditional pin-and-tube appliances, including those made from hand- or robotically bent wire with a "U"-shaped segment between adjacent pairs of teeth.

[0057] With systems or methods according to embodiments described herein, translational orthodontic tooth movement can be achieved in one or more, or all three directions in space (i.e., mesio-distal, buccolingual, and occlusal-gingival). Alternatively or in addition to tooth translation, one or more, or all three rotational movements including torque, angle, and rotation (i.e., buccolingual root torque, mesio-distal angulation, and mesial out-in rotation) are possible.

[0058] First Embodiment As described above, the systems and methods according to the first embodiment include or use pin-and-tube style appliances. The appliances according to the first embodiment are configured to be secured to multiple (or all) teeth in a patient's upper or lower jaw. In certain embodiments, the systems and methods according to the first embodiment are non-sliding systems and methods that use appliances with non-sliding mechanisms. In some instances, the appliances according to the first embodiment are fabricated after converting a three-dimensional (3D) digital OTA into a 3D digital FTA and designing (via computer-aided design or other suitable design techniques) an appliance shape configured to apply forces to the patient's teeth to transfer the teeth from the OTA to the FTA (or to an ITA, or from the ITA to an FTA or another ITA).

[0059] Examples of first embodiment instruments 100, 200, and 300 are shown in Figures 1-3, respectively. Instruments 100, 200, and 300 (and components thereof) may be fabricated from any suitable material, including but not limited to nitinol (NiTi), stainless steel, beta titanium, cobalt chromium or other metal alloys, polymers, or ceramics, and may be fabricated as a unitary, monolithic structure, or alternatively, from multiple separately formed components integrally connected into a unitary structure.

[0060] In FIG. 1 , the exemplary appliance 100 includes an arch structure and is configured for the upper jaw (to conform to the patient's maxillary arch). The appliance 100 does not include a palatal bow mechanism. The exemplary appliance 200 in FIG. 2 is similar to the appliance in FIG. 1 but includes a palatal bow mechanism 202. The exemplary appliance 300 in FIG. 3 includes an arch structure configured for the lower jaw (to conform to the patient's mandibular arch) and includes a stabilized lingual arch mechanism 302. In other examples, an appliance according to the first embodiment may be configured for the lower jaw and not include a lingual arch mechanism. Thus, certain examples of the appliance according to the first embodiment include a palatal bow mechanism or a lingual arch mechanism, while other examples of the appliance according to the first embodiment may be configured without a palatal bow mechanism or a lingual arch mechanism. Typically, the inclusion of a palatal bow mechanism or a lingual arch mechanism depends on the type of dental malocclusion or the clinician's preference (or both).

[0061] The exemplary devices 100, 200, and 300 shown in FIGS. 1-3 include multiple male connector elements and multiple spring members. Device 100 of FIG. 1 includes male connector element 104 and spring members 106 and 108. Device 200 of FIG. 2 includes male connector element 204 and spring members 206 and 208. Device 300 of FIG. 3 includes male connector element 304 and spring members 306 and 308. Each spring member comprises a portion or segment of device 100, 200, or 300 having a spring shape or configuration and resilience characteristics for, for example, applying one or more tension or compression forces, applying force in one or more of three directions, applying torque in one or more of three directions, or absorbing motion, or a combination thereof. In the exemplary devices 100, 200, and 300 shown in FIGS. 1-3, each spring member is disposed between a pair of adjacent male connector elements. In other examples, one or more spring members may be provided between male connector elements that are not directly adjacent to one another. In further embodiments, one or more pairs of adjacent male connector elements on a device may be connected by a rigid portion of the device instead of by a spring.

[0062] In exemplary appliances 100, 200, and 300, a mesiodistal spring is included between the female connector elements of the canine and second premolar and applies a force in a direction to close the space created by the extraction of the first premolar, for example, by pulling one or both adjacent teeth toward the other adjacent tooth (teeth not shown in FIGS. 1-3). In appliance 100, the mesiodistal spring is designated 108. In appliance 200, the mesiodistal spring is designated 208. In appliance 300, the mesiodistal spring is designated 308. In some other examples of the appliance according to the first embodiment, one or both mesiodistal springs may be omitted.

[0063] The example shown in Figures 1-3 includes a separate male connector element for each separate tooth in the jaw to be fixed. The embodiment of Figures 1-3 also includes a separate spring between each pair of adjacent male connector elements (and therefore between each pair of adjacent teeth when the appliance is attached to a patient). In other examples, the appliance according to the first embodiment may include fewer male connector elements than there are teeth in the jaw to be fixed, or may have springs positioned between one or more but not all pairs of adjacent male connector elements. Typically, the number of male connector elements and springs and the location of the teeth will depend, for example, on the desired tooth repositioning process or procedure as determined by the clinician.

[0064] Once appliance 100, 200, or 300 is secured to the patient's teeth, spring members 106 and 108, or 206 and 208, or 306 and 308 are configured to apply the necessary force to the teeth to move them from their OTAs to the desired FTAs, either directly in a single step or alternating in multiple steps, through one or more ITA(s). The spring members can be configured to move the teeth in one or more (or all three) translational directions. Alternatively or additionally, the spring members can be configured to move the teeth in one or more (or all three) rotational directions.

[0065] In the exemplary devices 100, 200, and 300 of Figures 1-3, the spring members are shown as having a helical or loop shape, with segments of the spring forming one or more loops. In other examples, one or more (or all) of the springs may have other suitable shapes, such as, but not limited to, a U-shape (having one or more U-shaped segments). In certain examples, the springs are formed by curved segments of a single arched structure of the device. In other examples, the springs are formed as separate components that are attached to (or form) the arched structure.

[0066] Examples of different U-shaped springs 400, 402, and 404 that can be used in the appliance according to the first embodiment are shown in Figures 4a-4c. In the example of Figure 4a, the U-shaped spring 400 is thicker in the occlusal-gingival direction, thereby limiting the flexibility of the appliance in that direction. In the example of Figure 4b, the side of the spring 402 that is to be attached to the more misaligned teeth is thinner and more flexible than the other parts of the spring. The spring can vary in thickness, being thinner (more flexible) on the side requiring more tooth displacement. In the example of Figure 4c, the U-shaped spring 404 is configured to be thin and flexible in a diagonal direction, thereby allowing the adjacent teeth to move simultaneously in the occlusal-gingival and buccolingual directions, e.g., in a diagonal occlusal-gingival and buccolingual directions.

[0067] In certain examples, the direction and magnitude of the force and torque applied by the springs depend, at least in part, on the shape, width, thickness, and length of the spring. In such examples, the shape, width, thickness, and length of each spring are selected and designed to produce the desired tooth movement and take into account the spring's location on the appliance (including the size and type of tooth to which the spring is connected). For example, the thickness and shape of each spring can be selected or designed to increase the spring's flexibility when adjacent teeth need to be displaced further or when teeth are smaller in size, including, but not limited to, the lower gingival region. In certain examples, a processing and software system with finite element analysis capabilities is used to determine the optimal shape and thickness of the springs to apply a selected force to accelerate tooth movement, for example, in one or more of the buccolingual, occlusal-gingival, and mesiodistal directions.

[0068] Further exemplary appliances 500 and 600 are shown in Figures 5 and 6, respectively. The exemplary appliance 500 of Figure 5 is configured for maxillary teeth and is similar to the exemplary appliance 200 of Figure 2, but includes a plurality of U-shaped spring members 506 between some of the adjacent pairs of male connector elements 504. The exemplary appliance 600 of Figure 6 is configured for lower law teeth and is similar to the exemplary appliance 300 of Figure 3, but includes a plurality of U-shaped spring members 606 between some of the adjacent pairs of male connector elements 604.

[0069] Additionally, appliances 500 and 600 include mesiodistal springs 508 or 608 between male connector elements secured to female connector elements of the canine and second premolars, for example, to close the space formed by an extracted first premolar (tooth not shown in FIGS. 5 and 6). The male connector elements 504 and 604 can have a configuration and operation similar to that described herein for male connector elements 104, 204, and 304 of FIGS. 1-3. Exemplary appliance 500 includes a palatal bow mechanism 502, and exemplary appliance 600 includes a lingual archwire mechanism 602. As described herein, palatal bow mechanism 502 and lingual archwire mechanism 602 may be similar to palatal bow mechanism 202 and lingual archwire mechanism 302, respectively. Other exemplary appliances according to the first embodiment may not include a palatal bow mechanism or a lingual archwire mechanism.

[0070] The appliances 500 and 600 can be designed to be installed after an initial or subsequently used appliance (such as, but not limited to, appliances 100, 200, or 300 shown in FIGS. 1-3 ) has moved teeth from an OTA to an ITA (or from one ITA to another) and then been removed. Thus, the appliances 500 and 600 can be designed to move teeth from an ITA to an FTA (or another ITA). Alternatively, the appliances 500 and 600 may be designed to move teeth from an OTA to an ITA or from an OTA to an FTA without changing the appliance at the ITA.

[0071] The exemplary instruments 100, 200, 300, 500, and 600 shown in Figures 1-3, 5, and 6 do not include a fixation device holder. However, in other examples, instruments 100, 200, 300, 500, and 600 may include one or more fixation device holders, such as, but not limited to, fixation device holders 812 and 904 (described in connection with the examples of Figures 8 and 9), to enable a clinician to secure one or more of the temporary fixation devices TADs (or other suitable fixation devices) described herein to fixation device holders 812 and 904.

[0072] The exemplary appliances 100, 200, 300, 500, and 600 shown in Figures 1-3, 5, and 6 include separate male connector elements that secure to each separate respective tooth in the jaw to which the appliance is secured. In other examples, the appliance according to the first embodiment may secure to fewer than all teeth in the jaw (or may include fewer male connector elements than teeth in the jaw to which it is secured). For example, the appliance according to the first embodiment may be configured as a cross-sectional appliance to move some, but not all, of the teeth in the patient's jaw.

[0073] An example of such a scenario is when only the front teeth are misaligned and need to be moved. In that example, the appliance according to the first embodiment can be configured with a male connector element to connect to the front teeth in the jaw (and not to connect to other teeth in the jaw). In other examples, the cross-section type of the appliance according to the first embodiment may be configured to open space for an implant or to align a tooth that is tilted toward an extraction space. In these examples, the appliance according to the first embodiment can be configured with a male connector element to connect to one or more teeth that need to be moved and create the desired space or correct the tilt (and not correct other teeth in the jaw).

[0074] As described above, the male connector element is configured to engage and connect with a female connector element or bracket attached to the surface of a tooth, which is attached to the tooth prior to placement of the appliance 100, 200, 300, 500, or 600.

[0075] Various examples and configurations of male connector elements and associated female connector elements can be used in various implementations of the first embodiment (and other embodiments) described herein. Particular examples of devices according to the first embodiment include the male connector element described and illustrated with reference to FIGS. 1-3, 5, and 6 (for securing to a female connector element as described for FIG. 7). Another exemplary device according to the first embodiment includes the male connector element described and illustrated with reference to FIGS. 8-12h (for securing to a female connector element as described for FIGS. 13a and 13b). Yet another exemplary device according to the first embodiment includes the male connector element described and illustrated with reference to FIG. 15a (for securing to a female connector element as described for FIG. 15b and shown in FIG. 15c). Yet another device according to the first embodiment includes the male connector element described and illustrated with reference to FIG. 16a (for securing to a female connector element as described for FIGS. 16b and 16c). Yet another example device according to the first embodiment includes a male connector element as described and illustrated with respect to Figure 17a (for securing to a female connector element as described with respect to Figure 17b). Yet another exemplary device according to the first embodiment includes a male connector element as described and illustrated with respect to Figures 18e and 25 (for securing to a female connector element as described with respect to Figures 26a-26f). Another exemplary device according to the first embodiment includes a male connector element as described and illustrated with respect to Figures 27a and 27b (for securing to a female connector element as described with respect to Figure 28). Yet another device according to the first embodiment includes a male connector element having other suitable configurations for securing to a female connector element having other suitable configurations.

[0076] In the examples shown in Figures 1-3, 5, and 6, each of the male connector elements includes a generally wedge-shaped body having a wide end and a narrow end, the wide end extending from or attached to the arcuate structure of the appliance. The narrow end of each male connector element has a protrusion and a recess that respectively engage a corresponding recess and protrusion on the female connector element when the appliance is attached to the patient's teeth.

[0077] 7 is a diagram illustrating an OTA image of a patient's upper and lower jaws, with female connector elements 700 attached to the lingual surfaces of the teeth on the upper and lower arches. Female connector elements 700 are attached to the teeth on the upper arch, and similar female connector elements 700 are attached to the teeth on the lower arch. In other examples, the female connector elements 700 may be attached to the buccal surfaces of the teeth, for example, if preferred by the clinician.

[0078] Each separate, respective female connector element 700 is secured to a respective tooth. According to the first and second embodiments described herein, the female connector elements provide an interface for connecting one or more appliances to the teeth. While the illustration in FIG. 7 shows every tooth in each jaw having a female connector element, other embodiments may use separate, respective female connector elements on less than every tooth in the upper or lower jaw, for example, on a subset of teeth selected by the clinician.

[0079] The female connector elements 700 can be attached to the teeth via direct or indirect bonding, or other suitable fastening means for securing the elements to the tooth surface. Bonding materials may include, but are not limited to, adhesives such as composite resins. In the case of indirect bonding, the clinician may use a jig to enhance the accuracy of bracket placement. In certain instances, one or more (or all) female connector elements 700 are customized for each tooth size or shape and configured to have a minimal profile (to minimize size in the dimension extending away from the tooth, i.e., buccolingually). Further examples may be configured to minimize size in the mesiodistal or occlusal-gingival directions, or a combination thereof. In instances where the female connector elements 700 are attached to the teeth via direct bonding, an intraoral scan or arch impression can be taken after attaching the female connector elements to the teeth. The impression or scan (or both) contains and thus provides information to help identify the location of the female connector elements on the teeth. The information is used by a clinician, fabricator, or technician, for example, to help identify the proper location of the appliance and to place or form one or more male connector elements to properly align with one or more female connector elements on the teeth.

[0080] The female connector element 700 of Figure 7 is configured to mate with male connector elements having configurations such as those shown in the exemplary appliances 100, 200, 300, 500, and 600 of Figures 1-3, 5, and 6. Each female connector element 700 of Figure 7 includes a generally wedge-shaped basket configuration and is configured to receive a respective one of the generally wedge-shaped male connector elements 104, 204, 304, 504, or 604 when the appliance 100, 200, 300, 500, or 600 is placed on a patient's teeth. The inner surface of each generally wedge-shaped basket structure has recesses and protrusions that respectively engage corresponding protrusions and recesses on the male connector element when the male connector element is generally received in the wedge-shaped basket structure. In this manner, when the male connector element is received within the generally wedge-shaped basket structure, the male connector element (and therefore the device) is secured to the female connector element (and therefore the tooth to which it is attached). In other examples, the female connector elements of devices 100, 200, 300, 500, and 600 may have other suitable engaging and securing configurations for the associated male connector element, including, but not limited to, further embodiments such as those described with reference to Figures 13b, 15b, 16b, 17b, or 26e.

[0081] The device according to the first embodiment and the female connector element associated with the first embodiment are fabricated by any suitable method, including but not limited to molding, casting, machining, 3D printing, stamping, extrusion, etc. However, in particular examples, the device according to the first embodiment or the female connector element (or both) are fabricated by cutting the two-dimensional (2D) shape of the device from a 2D sheet of material and folding the 2D shape into the desired 3D shape of the device. This method described herein is particularly suitable for fabricating the device according to the example first embodiment described herein.

[0082] By cutting 2D members from flat sheet material instead of traditional single-diameter wire, a greater variety of three-dimensional shapes can be fabricated compared to shapes created by bending single-diameter wire. The cut 2D members may be designed or varied in width and length so that, when bent into a desired shape, the thickness, width, and length dimensions of a portion of a 3D instrument can be varied. In this way, the 2D members can be cut to assume the desired thickness, width, and length shape of a spring member, arm, or other component of the instrument when bent into a 3D-shaped member of the instrument.

[0083] An example of a three-dimensionally shaped component of a device formed by folding a 2D component cut from a flat sheet of material is shown in Figure 17a. In a particular example, the sheet material is Nitinol (NiTi). In other examples, the sheet material may be any suitable material, such as, but not limited to, stainless steel, beta titanium, cobalt chromium or other metal alloys, polymers, or ceramics. In other examples (where practical for the desired device shape), a device according to the first embodiment may be constructed from wire that is curved or otherwise formed into the desired 3D shape.

[0084] The device 1700 of Figure 17a includes male connector elements 1702 formed as relatively simple linear members configured to engage and securely engage female connector elements 1706, as shown in Figure 17b. Each female connector element 1706 includes a linear slot structure that receives a respective linear member of the male connector element 1702, as shown in Figure 17b. In a particular example, the female connector elements 1706 are twin bracket type connectors.

[0085] Each male connector element 1702 is separated from each adjacent male connector element 1702 by a spring member 1704. In other examples, one or more male connector elements may be separated from one or two (or more) adjacent male connector elements by a rigid portion of the device that does not have a spring member. In the example shown in FIG. 17a, each spring member 1704 has a generally U-shaped configuration as described herein. In other examples, one or more (or each) spring member 1704 may have, without limitation, other spring shapes shown and described herein or other suitable shapes cut from a flat sheet of material and bent into a 3D shape. In other examples, the device 1700 of FIG. 17a may include other types of male connector elements (such as, but not limited to, those described herein in connection with FIGS. 1-3, 5, 6, 8-12h, 15a, 16a, 17a, 18c-18f, 25, 27a, and 27b) and / or other types of spring members described herein, but not limited to, the shape and type of spring member may be selected and configured to provide the desired movement, for example, and may be based at least in part on the configuration and size of the tooth to which the spring is to be connected.

[0086] <Second embodiment> As described above, a system or method according to an example of the second embodiment includes or uses an appliance having multiple separate arms configured to connect to a corresponding plurality of the patient's teeth, with each arm of the appliance configured to connect to a different individual tooth relative to each other arm of the appliance. In further examples of the second embodiment, the appliance described herein may include one arm configured to connect to multiple teeth, or multiple separate arms configured to connect to corresponding ones of the patient's teeth, or various combinations of arm-to-tooth connections. In some examples, an appliance according to the second embodiment is fabricated after converting a 3D digital OTA into a 3D digital FTA and designing (via computer-aided design or other suitable design techniques) an appliance shape configured to apply forces to the patient's teeth to transfer the teeth from the OTA to the FTA (or ITA, or from the ITA to the FTA or another ITA).

[0087] Examples of instruments 800, 900, 1000, and 1100 according to the second embodiment are shown in Figures 8-11, respectively. Instruments 800, 900, 1000, and 1100 (and components of the instruments) may be fabricated from any suitable material, including but not limited to nitinol (NiTi), stainless steel, beta titanium, cobalt chromium, or other metal alloys, polymers, or ceramics, and may be fabricated as multiple separately formed components connected together in a single, uniform structure.

[0088] The appliances 800 and 1000 shown in Figures 8 and 10, respectively, may be configured to be placed on a patient's upper jaw. In certain instances, the appliances 800 or 1000 may be configured to assist in closing an extraction space after the patient's first bicuspid tooth has been extracted or after other teeth have been repositioned (or both). Meanwhile, the appliances 900 and 1100 of Figures 9 and 11, respectively, may be configured to be attached to a patient's lower jaw.

[0089] 8 and 10, exemplary appliances 800 and 1000, respectively, include an arched bar 802 or 1002 and are configured for the maxilla (to follow the arch of the patient's maxilla). Appliances 800 and 1000, respectively, include a palatal arch feature 804 or 1004. In other examples, the palatal arch feature 804 or 1004 may be omitted.

[0090] Each of the appliances 800 and 1000 includes a plurality of separate arms (arms 806 in FIG. 8 and arm 1006 in FIG. 10). The examples shown in FIGS. 8 and 10 include twelve arms 806 or 1006 that are separately and individually fixed to twelve associated teeth in a one-to-one relationship. In other embodiments, the appliance may have any other suitable number of arms, including fewer or more than twelve arms. The number of arms may equal the number of teeth in the jaw to be moved.

[0091] Each of the arms 806 on appliance 800 (and each of the arms 1006 on appliance 1000) may have the same configuration (length, shape, width, etc.) as each of the other arms of the appliance, as shown in Figures 8 and 10. Some (or each) of the arms 806 of appliance 800 (or arms 1006 of appliance 1000) may have a different configuration (length, shape, width, etc.) than some or each of the other arms of the appliance. In certain instances, the configuration, including shape and size, of each arm may depend on the desired movement and size of the tooth to which the arm is secured (and may be different for different arms and teeth).

[0092] Each arm 806 (or 1006) has one end extending from or connected to bar 802 (or 1002) and a second end having a male connector element 808 (or 1008) formed thereon or connected thereto. Thus, a separate male connector element is formed on or connected to each separate arm. Each male connector element 808 is configured to engage with a respective female connector element or bracket when appliance 800 (or 1000) is attached to the patient's tooth. In certain instances, the male connector elements are configured to secure to and remain secured to a female connector element bonded to the patient's tooth until the clinician removes the appliance.

[0093] Each arm 806 (or 1006) has a spring member 810 (or 1010) along its length. In the examples of Figures 8 and 10, the spring members 810 and 1010 are located at the ends of the respective arms 806 and 1006 (i.e., the ends corresponding to the arm ends extending from or connected to the bar 802 or 1002 and opposite the arm ends at which the male connector elements 808 or 1008 are located). However, in other embodiments, the spring members 810 (or 1010) may be located at other positions along the length of the arm 806 (or 1006), such as, but not limited to, at the center of the length of the arm 806 (or 1006) or towards the arm ends at which the male connector elements 808 or 1008 are located.

[0094] The spring members 810 and 1010 may have any suitable configuration and can be designed and fabricated to provide a force or torque (or both) in a desired direction or magnitude (or both). In certain examples, the spring members can be designed and / or constructed using computer-aided design and fabrication techniques. The spring members 810 and 1010 may have the same configuration on each arm of the instrument, as shown in FIGS. 8 and 10 . Alternatively, the spring members of some (or each) of the arms 806 of instrument 800 (or arm 1006 of instrument 1000) may have a different configuration than some or each of the other arms of the instrument. The spring members 810 (or 1010) may be formed as an integral, single-piece structure with the rest of the arm 806 (or 1006), as shown in FIGS. 8 and 10 . In another embodiment, spring member 810 (or 1010) may be formed separately from the remaining arm 806 (or 1006) and then coupled to arm 806 (or 1006) after it has been formed.

[0095] Each spring member 810 of the example device 800 of Figure 8 may be made up of multiple U-shaped segments along a portion of the length of its associated arm 806. In other examples, each spring member may include a single (only one) U-shaped segment, or may have fewer or more U-shaped segments than shown in the example of Figure 8.

[0096] Each spring member 1010 of the exemplary appliance 1000 of FIG. 10 may be comprised of a spiral or loop-shaped segment forming a single loop along a portion of the length of its associated arm 1006. In other embodiments, each spring member 1010 may include multiple loops along one or more segments of the length of its associated arm 1006. In other embodiments, other suitable spring configurations may be used for one or more (or each) arms 806 or 1006. In other embodiments, two or more spring members (having the same or different configurations) may be included in each arm 806 or 1006. The geometry (size, shape, length, etc.) of the spring members and arms may be designed and selected based on a variety of factors, including, but not limited to, tooth morphology or dimensions, facial morphology, the type of malocclusion to be addressed, and other factors specific to each patient.

[0097] As described above, the exemplary appliances 800 and 1000 shown in FIGS. 8 and 10 include a palatal bow mechanism (804 in FIG. 8 and 1004 in FIG. 10). In the example shown in FIGS. 8 and 10, the palatal bow mechanism 804 and 1004 each includes a plurality of holders 812 or 1012 for a corresponding plurality of fixation devices, such as, but not limited to, screws or other temporary fixation devices (TADs). Three fixation device holders 812 or 1012 are shown in FIGS. 8 and 10, respectively. In other embodiments, one, two, or more fixation device holders 812 or 1012 may be included in the palatal bow mechanism 804 or 1004. In still other embodiments, one or more fixation device holders may be provided in other suitable locations on the appliance. In still other embodiments, the fixation device holders 812 and 1012 may be omitted from the palatal bow mechanism 804 and 1004. In a particular instance, the inclusion, number and location of the anchor holders 812 and 1012 will depend, at least in part, on the type of malocclusion to be addressed and other factors specific to each patient.

[0098] One or more anchor holders 812 and 1012 may be used to receive or otherwise hold a TAD or other anchorage device that is secured to the patient's palate. Thus, if the clinician desires additional fixation of the appliance, the clinician may decide to use one or more TADs. For example, before or after the male connector element 808 (or 1008) of the appliance 800 (or 1000) is secured to the female connector element previously bonded to the patient's teeth, the clinician may secure one or more implantable screws or other TAD structures to one or more anchor holders 812 (or 1012) and to the patient's palate. According to the examples of FIGS. 8 and 10 , the anchor holders 810 and 1010 are ring-shaped or annular with a central opening through which an elongated screw or other suitable TAD structure extends, securing the appliance to the patient's palate once the screw or other TAD structure is implanted in the patient's palate. Prior to implantation, the clinician may anesthetize the area of ​​the patient's palate where the TAD will be implanted.

[0099] 9 and 11, exemplary appliances 900 and 1100 include an arched bar 902 or 1102, respectively, configured for the mandible (to follow the arch of the patient's mandible). The appliances 900 and 1100 of Figures 9 and 11 do not include a lingual archwire support mechanism. However, other embodiments may include a lingual archwire support mechanism (e.g., without limitation, a mechanism similar to mechanism 302 of Figure 3).

[0100] Each appliance 900 and 1100 includes two fixation device holders 904 or 1104 extending from an arched bar 902 or 1102 on either the left or right side of the appliance. Each fixation device holder 904 or 1104 is configured to receive and hold a suitable fixation device, such as, but not limited to, an implantable screw or other suitable TAD structure for securing the appliance to the lingual side of the mandible.

[0101] Although two anchor holders 904 or 1104 are shown in each of FIGS. 9 and 11 , in other examples, one or more anchor holders 904 or 1104 may be provided on the appliance 900 or 1100. In still other examples, anchor holders 904 and 1104 may be omitted from the appliance 900 or 1100. In certain examples, the inclusion, number, type, and location of anchor holders 904 and 1104 will depend, at least in part, on the type of malocclusion to be addressed and other factors specific to each patient. Each anchor holder 904 or 1104 is positioned on the lingual side of the appliance and may receive an anchor device, such as a TAD, secured to the lingual side of the patient's mandible, but may otherwise have the configuration and operate as described herein for anchor holder 812 or 1012. In other examples, the anchor holders may be positioned on the buccal side of the patient's jaw. In other embodiments, any other suitable mechanism or combination of mechanisms may be used to secure the appliance to the patient's jaw.

[0102] 9 and 11 each include a plurality of arms 906 or 1106 with spring members 910 or 1110. Each of the exemplary appliances 900 and 1100 also includes a respective male connector element 908 or 1108 at one end of each arm 906 or 1106, respectively. The arms 906 or 1106, spring members 910 and 1110, and male connector elements 908 and 1108 may be similar in configuration and operation to the arms 806 and 1006, spring members 810 and 1010, and male connector elements 808 and 1008 described herein, but with respect to the teeth of a patient's mandible.

[0103] As described above, each male connector element 808, 908, 1008, and 1108 is configured to engage with a respective female connector element or bracket when the appliance 800, 900, 1000, or 1100 is placed on a patient's tooth. In the example appliances shown in Figures 8-11, each male connector element 808, 908, 1008, and 1108 may be configured as a single, unitary structure formed separately from or integrally with the arm to which it is connected. Such unitary structures may be formed by any suitable fabrication technique, including, but not limited to, molding, casting, machining, 3D printing, stamping, cutting, extrusion, etc. In some embodiments, each male connector element is formed as a unitary structure with the rest of the device by cutting a 2D shaped member from a sheet of suitable material, such as, but not limited to, Nitinol (NiTi), stainless steel, beta titanium, cobalt chrome or other metal alloy, polymer, or ceramic, and bending the 2D shaped member into the 3D shaped member of the device. In other embodiments, one or more (or each) male connector elements 808, 908, 1008, and 1108 are formed as multiple separate components connected by arms to form the arms and male connecting structure of device 800, 900, 1000, or 1100.

[0104] An example of a male connector element and an arm structure comprised of multiple components that connect together and to the arched bar of a device is described with reference to Figures 12a-12h. The example shown in Figures 12a-12h provides a male connector element having a configuration as shown in exemplary devices 800, 900, 1000, and 1100 of Figures 8-11. However, male connector elements such as those shown in Figures 12a-12h may also be used with other devices described herein, including, but not limited to, devices 100, 200, 300, 500, and 600 depicted in Figures 1-3, 5, and 6.

[0105] 12a-12h includes an arm structure 1200 (shown in FIG. 12a), one or more (in the illustrated example, a plurality) first arm connector components 1202 (shown in FIG. 12b) having an arched structure or bar 1201, a second arm connector component 1204 (shown in FIG. 12c), a first male connector element 1206 (shown in FIGS. 12d, 12e, and 12f in rear, front, and side views, respectively), and a second male connector element 1208 (shown in FIGS. 12g and 12h in rear and front views, respectively). In certain examples, arm structure 1200 may correspond to any one or more of arms 806, 906, 1006, 1106 of instruments 800, 900, 1000, and 1100 described herein. Arm structure 1200 includes a first end 1210 configured to attach to a bar (such as, but not limited to, bar 802, 902, 1002, or 1102 of instrument 800, 900, 1000, or 1100). In the example shown in FIG. 12a, first end 1210 of arm structure 1200 is formed into a loop-shaped portion that fits within a corresponding loop-shaped groove of one or both of first and second arm connector components 1202 and 1204 (shown in FIGS. 12b and 12c).

[0106] Additionally, arm structure 1200 includes a second end 1212 configured to attach a male connector element. In the example shown in FIG. 12a, second end 1212 of arm structure 1200 is formed into a loop-shaped portion that fits within a corresponding loop-shaped groove of one or both of first and second male connector element components 1206 and 1208 (shown in FIGS. 12d-12h). Arm structure 1200 also includes a central portion 1214 between the first and second ends. One or more spring members (such as, but not limited to, those described herein) may be formed or otherwise disposed in central portion 1214.

[0107] First and second arm connector components 1202 and 1204 shown in Figures 12b and 12c are configured to connect to one another. Each first arm connector component 1202 may be formed as part of (or integral with) an arched structure or bar 1201 of the instrument, as shown in Figure 12b. In other embodiments, each first arm connector component 1202 is formed separately from the arched structure or bar and attached to the arched structure or bar by adhesive, welding, or any other suitable attachment mechanism to form the structure shown in Figure 12b. Arched structure or bar 1201 may correspond to arched structures 802, 902, 1002, 1102 described herein with reference to the embodiments of Figures 8 and 11, or other suitable examples described herein.

[0108] One or both of the first and second arm connector components 1202 and 1204 include grooves 1215 and 1217 for receiving the first end 1210 of the arm structure 1200 between the first and second arm connector components 1202 and 1204. More specifically, the first end 1210 of the arm structure 1200 is disposed between the first and second arm connector components 1202 or 1204, and the arm connector components 1202 and 1204 together encase the first end 1210 of the arm structure 1200 within the grooves 1215 and 1217. The grooves 1215 and 1217 extend to the edges of the respective first and second arm connector components 1202 and 1204 such that when the connector components 1202 and 1204 are coupled together, the central portion 1214 of the arm structure 1200 extends outward from the connector components 1202 and 1204.

[0109] One of the first and second arm connector components 1202 and 1204 (e.g., connector component 1202) includes a protrusion 1216 that includes one or more (three in FIG. 12b ) projections that engage with one or more corresponding recesses or openings 1218 on the other of the first and second arm connector components 1202 and 1204 (e.g., connector component 1204). The protrusions 1216, recesses, and openings 1218 aid in properly aligning the first and second arm connector components 1202 and 1204 with each other and with the arm structure 1200 during assembly. Furthermore, the protrusions 1216, recesses, and openings 1218 are configured to connect the first and second arm connector components 1202 and 1204 with a snap fit or a friction fit. In further examples, alternative or additional connection mechanisms may be used to connect the connector components 1202 and 1204 together, including, but not limited to, screws, adhesives, welding, etc. For example, one or both of the first and second arm connector components 1202 and 1204 may include one or more openings 1220 for receiving one or more screws, bolts, or other threaded connectors (not shown). In such an example, the one or more openings may be threaded for threaded engagement with the screws, bolts, or other threaded connectors (not shown).

[0110] 12d-12h show first and second male connector elements 1206 and 1208 configured to connect to one another. One or both of the first and second male connector elements 1206 and 1208 include grooves 1222 and 1224 for receiving the second end 1212 of the arm structure 1200 between the first and second male connector elements 1206 and 1208. More specifically, the second end 1212 of the arm structure 1200 is positioned between the first and second male connector elements 1206 or 1208, and the male connector elements 1206 and 1208 are joined to encase the second end 1212 of the arm structure 1200 within the grooves 1222 and 1224. The grooves 1222 and 1224 extend to the edges of the respective first and second male connector element parts 1206 and 1208 such that when the connector components 1206 and 1208 are coupled together, the central portion 1214 of the arm structure 1200 extends outward from the male connector element parts 1206 and 1208.

[0111] One of the first and second male connector elements 1206 and 1208 (e.g., connector component 1208) includes one or more protrusions 1226 (one in FIG. 12g) that engage with one or more corresponding recesses or openings 1228 in the other of the first and second male connector elements 1206 and 1208 (e.g., connector component 1206). The protrusions 1226, recesses, or openings 1228 aid in properly aligning the first and second male connector elements 1206 and 1208 with each other and with the arm structure 1200 during assembly. Additionally, the protrusions 1226, recesses, or openings 1228 can be configured to provide a snap-fit ​​or friction-fit connection between the first and second male connector elements 1206 and 1208. In further examples, alternative or additional connection mechanisms may be used to connect the male connector elements 1206 and 1208 together, such as, but not limited to, screws, adhesives, welding, etc. For example, one or both of the first and second male connector elements 1206 and 1208 may include one or more openings 1230 for receiving one or more screws, bolts, or other threaded connectors (not shown). In such an example, the one or more openings may be threaded for threaded engagement with the screws, bolts, or other threaded connectors (not shown).

[0112] Thus, the first and second male connector elements 1206 and 1208 may be assembled and connected to one end of the arm structure 1200. The other end of the arm structure 1200 may be assembled and connected to the arched bar of the appliance. In that example, appliance 800, 900, 1000, or 1100 may be made up of multiple separately formed components that are assembled and connected together to form a single, integral appliance structure.

[0113] In such examples, each component of the instrument can be formed separately by any suitable manufacturing technique, including, but not limited to, molding, casting, machining, 3D printing, stamping, extruding, cutting, and bending (e.g., cutting a two-dimensionally shaped member from a sheet and bending the two-dimensionally shaped member into a three-dimensionally shaped member as described herein), and then assembled with one or more of the other components of the instrument. In such examples, the arm structure 1200 can be formed by any suitable technique, including, but not limited to, those described above, or by bending techniques. For example, automated or robotically controlled bending techniques can be used to form or bend the precise spring and arm configuration desired from suitable materials, such as, but not limited to, nitinol (NiTi), stainless steel, beta titanium, cobalt chrome or other metal alloys, polymers, or ceramics. In other examples, one or more (or all) of the components of the instrument structure can be formed together as a single, integrally formed structure.

[0114] As noted above, the examples shown in Figures 12a-12h provide male connector elements having configurations such as those shown in exemplary devices 800, 900, 1000, and 1100 of Figures 8-11. Such male connector elements are configured to engage and securely engage female connector elements having configurations such as those shown in Figures 13a and 13b.

[0115] For example, as best shown in FIGS. 12e and 12f, male connector component 1206 includes a backing portion 1232 (the portion including openings 1228 and 1230) and an extension structure 1234. Extension structure 1234 is configured to engage a female connection element, for example, of the type shown in FIGS. 13a and 13b. Extension structure 1234 includes a shelf-shaped extension 1236 extending outwardly from backing portion 1232. Extension structure 1234 also includes a pair of leg members 1238 and 1240 extending from shelf-shaped extension 1236 and spaced apart from each other by a gap 1242. As shown in FIG. 12f, leg members 1238 and 1240 are spaced apart from each other by a portion of the extended length of shelf-shaped extension 1236, via gap 1244. The free end of each leg member 1238 and 1240 has a flared or widened portion 1239 and 1241, respectively. The male connector component 1206 can be fabricated from any suitable material, including, but not limited to, nitinol, stainless steel, beta-titanium, cobalt chrome or other metal alloys, polymers, or ceramics, or other materials that exhibit resiliently flexible properties and can deflect inwardly to reduce the width of the extension structure 1234 when force is applied to the leg members 1238 and 1240 (directed to push the leg members 1238 and 1240 toward each other). In this condition, for example, the extension structure can be inserted into a female connector element of the type shown in FIGS. 13a and 13b. Once inserted into the female connector element, the force is released, allowing the leg members 1238 and 1240 to resiliently move outward toward their original positions to secure the male connector element (formed by components 1206 and 1208) to the female connector element. In certain examples, male connector component 1206 (including shelf-shaped extension structure 1234 and leg members 1240 and 1238) is formed as a one-piece, integrally formed structure. In other examples, male connector component 1206 is formed from multiple separate components connected together.

[0116] FIG. 13a shows an OTA image of a patient's maxilla, on which exemplary female connector elements 1300 have been attached to the lingual surfaces of teeth in the upper arch. In other examples, the female connector elements 1300 may be attached to the buccal surfaces of teeth, for example, if preferred by the clinician. Separate female connector elements 1300 are secured to individual teeth. The female connector elements provide interfaces for connecting one or more appliances to the teeth, according to the first and second embodiments described herein. While FIG. 13a shows female connector elements on all teeth in each jaw, in other examples, separate female connector elements may be used on some teeth, rather than all teeth in the maxilla or mandible, for example, selected by the clinician.

[0117] The female connector element 1300 can be attached to a tooth via direct or indirect bonding or other suitable means to firmly secure the element to the tooth surface. Bonding materials may include adhesives, such as, but not limited to, composite resins. In the case of indirect bonding, the clinician may use a jig to enhance the accuracy of bracket placement. In certain instances, one or more (or all) female connector elements 1300 are customized according to the size or shape of each tooth and configured to have a minimal profile (to minimize size in the dimension extending away from the tooth, i.e., buccolingually, or mesiodistally or occlusogingivally, or any combination thereof).

[0118] Figure 13b shows an example of the female connector element 1300 of Figure 13a. In the example of Figure 13b, the female connector element 1300 includes a backing portion 1302 configured to be bonded to a patient's tooth surface. The female connector element 1300 of Figure 13b also includes a shelf-shaped extension structure 1304 extending outward from the backing portion 1302. The female connector element 1300 of Figure 13b also includes first and second L-shaped extension structures 1306 and 1308, which also extend outward from the backing portion 1302. The extension structures 1304, 1306, and 1308 extend outward in the same direction from the backing portion 1302. However, the shelf-shaped extension structure 1304 has a surface with a planar dimension that extends in a direction perpendicular to the planar dimension of each of the L-shaped extension structures (horizontally in Figure 13b). The extension structures 1304, 1306, and 1308 are arranged such that a gap 1310 is provided between the L-shaped extension structures 1306 and 1308, and a gap 1312 is provided between the shelf-shaped extension structure 1304 and the L-shaped extension structures 1306 and 1308.

[0119] The female connector element 1300 can be fabricated from any suitable material, such as, but not limited to, nitinol, stainless steel, beta-titanium, cobalt chrome or other metal alloys, polymers, ceramics, or other materials that exhibit resiliently flexible properties and can flex outward to increase the width of the gap 1310 when a force is applied to the L-shaped extension structures 1306 and 1308 (directing the L-shaped extension structures away from each other). In this state, the extension portion 1234 of the male connector element can be inserted into the gap 1310. Once inserted, the force can be released, allowing the L-shaped extension structures 1306 and 1308 to resiliently move toward each other to their original position, securing the male connector element to the female connector element. In a particular example, the shelf-shaped extension 1236 of the male connector component 1206 fits into the gap 1312 of the female connector element 1300 when the extension portion 1234 of the male connector element is received in the gap 1310. In other examples, the L-shaped extension structure of the female connector element may be relatively rigid (configured to not flex outwardly significantly or at all), and the resilient flexibility of the leg members 1236 and 1238 of the male connector element may be sufficient to allow the male connector element to be inserted into the gap 1310 without the L-shaped extension structures 1306 and 1308 of the female connector element flexing outward. In certain examples, the female connector element 1300 (including the shelf-shaped extension structure 1304 and the L-shaped extension structures 1306 and 1308) is formed as a one-piece, integrally formed structure. In other examples, the female connector element 1300 may be formed from multiple separate components connected together.

[0120] Each of the L-shaped extension structures 1306 and 1308 of the female connector element 1300 includes a free end with a lip or L-extension that extends toward the other of the L-shaped extension structures. When the extension portions 1234 of the male connector element 1200 are received within the gaps 1310 and 1312 of the female connector element 1300, the lips or L-extensions of the L-shaped extension structures 1306 and 1308 snap back onto the leg members 1238 and 1240 of the male connector element 1200, retaining and securing the male connector element, as described above. The flared or widened portions 1239 and 1241 of the leg members 1238 and 1240 and the shelf-shaped extension 1236 help to secure and maintain the male connector element 1200 in proper alignment within the female connector element 1300 when secured and installed. In this position, the male connector element 1200 can remain secured to the female connector element 1300 until the clinician removes the male connector element (e.g., by pushing the leg members 1236 and 1238 of the male connector element inward sufficiently until the L-shaped extension structures 1306 and 1308 are disengaged and the male connector element is pulled away from the female connector element).

[0121] In certain examples, male connector elements 808, 908, 1008, and 1108 may be configured as described herein with respect to Figures 12a-12g and mated with female connector element 1300 as described herein with respect to Figures 13a-13b. However, in other examples, male connector elements 808, 908, 1008, and 1108 according to the second embodiment may be similar to male connector elements 104, 204, 304, 504, and 604 described herein with respect to the first embodiment. In such examples, the female connector element may be configured similar to female connector element 700 of Figure 7. Similarly, other examples of the first embodiment may include male connector elements as described herein with respect to Figures 12a-12g and mated with female connector element 1300 as described herein with respect to Figures 13a-13b.

[0122] In other examples, male connector elements according to the second embodiment (including appliances 800, 900, 1000, and 1100) or on appliances according to the first embodiment may be adapted to engage and secure with female connector elements 1501 as shown in Figures 15b and 15c in other suitable configurations, such as, but not limited to, the configuration of the example male connector element shown in Figure 15a. Female connector elements 1501 are shown mated to teeth in Figure 15c.

[0123] The male connector element 1500 of FIG. 15a comprises a shaped body portion having first and second arm portions 1504 and 1506. Each arm portion 1504 and 1506 is connected to the other at a first end 1508 and extends to a free end 1510, 1512, respectively. The arms 1504 and 1506 are spaced apart (except at the connecting end 1508) to form a gap 1502 between the arms, extending along a portion of the length of each arm. The male connector element is made of a material that is sufficiently resilient so that the free ends of the arms 1504 and 1506 can be moved further apart or away from each other and will resiliently return to their original state upon release of the force. The further the arms 1504 and 1506 are moved apart, the greater the width dimension of the gap 1502 between the arms 1504 and 1506. In that state, the male connector element 1500 is placed over the female connector element. Once placed over the female connector element, the force on the arms 1504 and 1506 is released, allowing the arms to resiliently move toward an unconstrained or passive state, locking or securing the male connector element to the female connector element.

[0124] The female connector element shown in Figure 15b includes a backing portion 1514 configured to be bonded to the surface of a patient's teeth. Extending outwardly from the backing portion 1514 is an extension portion 1516 made up of four hook- or L-shaped extension members 1518. When the arms 1504 and 1506 of the male connector element 1500 are spaced apart as described above, the male connector element 1500 is placed over the female connector element, with the hook-shaped extension members 1518 received in the gaps 1502 between the arms 1504 and 1506, and the arms 1504 and 1506 received within the female connector element behind the hook- or L-shaped free ends of the hook-like extension members 1518. In that state, the force on arms 1504 and 1506 is released, causing the arms to resiliently move toward their unconstrained or passive state, locking or securing arms 1504 and 1506 between backing portion 1514 and the L-shaped free ends of hooks or hook-like extension members 1518 of female connector element 1501, as shown in Figure 15c. In this state, male connector element 1500 can remain secured to female connector element 1501 until the clinician removes the male connector element (e.g., by pushing arms 1504 and 1506 outward enough to disengage the L-shaped free ends of hooks or hook-like extension members 1518, thereby separating the male connector element from the female connector element).

[0125] In other examples, male connector elements according to the second embodiment (including instruments 800, 900, 1000, and 1100) or on instruments according to the first embodiment may be adapted to engage and secure with female connector elements 1601 as shown in FIGS. 16b and 16c in yet other suitable configurations, such as, but not limited to, male connector element 1600 shown in FIG. 16a. Male connector element 1600 of FIG. 16a comprises a shaped body portion having first and second arm portions 1604 and 1606. Each arm portion 1604 and 1606 is connected to the other arm portion at a first end 1608 and extends to free ends 1610 and 1612, respectively. Free ends 1610 and 1612 include widened or L-shaped portions with extensions extending outward from each arm portion (away from the other of the two arms). Arms 1604 and 1606 are spaced apart (except for connecting end 1608) to define a gap 1602 between the arms and extend along a portion of the length of each arm. The male connector element is fabricated from a sufficiently elastic material that the free ends of arms 1604 and 1606 can be moved toward each other and resiliently return to their original state when the force is released. When arms 1604 and 1606 are pressed toward each other, the width dimension of gap 1602 between arms 1604 and 1606 decreases. In this state, male connector element 1600 is placed within the receptacle of female connector element 1601. Once placed within the receptacle of the female connector element, the force on arms 1604 and 1606 is released, allowing the arm portions to resiliently move outward toward an unforced or passive state, locking or securing the male connector element to the female connector element.

[0126] The female connector element shown in FIG. 16b includes a backing portion 1614, the back surface of which (the surface facing inward in the figure) is configured to be bonded to the surface of a patient's tooth. Extending outward from the backing portion 1614 are box-shaped extension portions 1616, each having an opening 1618 forming a receptacle. The box-shaped structure of extension portion 1616 includes two side walls 1620 and 1622, each having openings 1621 and 1623. Openings 1621 and 1623 are configured (in shape and size) to receive free ends 1610 and 1612, which include widened or L-shaped ends on the arms of male connector element 1600 when male connector element 1600 is secured to female connector element 1601.

[0127] The arms 1604 and 1606 of the male connector element 1600 are moved toward one another as described above, and the male connector element 1600 can be inserted into the opening 1618 of the female connector element 1601 until the widened portions or L-shaped ends on the free ends 1610 and 1612 of the arms of the male connector element 1600 are aligned with the openings 1621 and 1623 in the side walls 1620 and 1622 of the female connector element 1601. In this state, the elastic force of the arms 1604, 1606 is released, causing the arms 1604, 1606 to elastically move outward, engaging and inserting the widened portions or L-shaped ends of the free ends 1610 and 1612 of the arms into the openings 1621 and 1623 in the side walls 1620 and 1622, thereby locking or securing the male connector element 1600 to the female connector element 1601. In this position, the male connector element 1600 can remain secured to the female connector element 1601 until the clinician removes the male connector element (e.g., by moving the arms 1604 and 1606 inward toward each other sufficiently to pull the widened portions or L-shaped ends on the free ends 1610 and 1612 of the arms out of the openings 1621 and 1623 in the side walls 1620 and 1622, and then pulling the male connector element away from the female connector element).

[0128] In other examples, the male connector elements on the second embodiment (including instruments 800, 900, 1000, and 1100) or instruments according to the first embodiment may have other suitable configurations, such as, but not limited to, the exemplary male connector element configurations shown in Figures 18e and 18f. In exemplary instruments 1810 and 1820 shown in Figures 18e and 18f, each male connector element 1802 or 1822 has a T-shaped configuration for engaging and securing with a female connector element. In such examples, the female connector elements may have corresponding T-shaped slots for selectively receiving the T-shaped male connector element.

[0129] Figure 25 shows an example of a male connector element 2500 having a T-shaped configuration that can be used with the embodiments described herein, including but not limited to the embodiments of Figures 18e or 18f. The male connector element 2500 of Figure 25 has a T-shaped body structure provided at the end of an arm of an instrument. The T-shaped body structure has a first portion 2501 that extends in the direction of the arm (vertical in Figure 25) and a second portion 2502 that extends transversely (such as, but not limited to, generally vertically) to the first portion 2501 (horizontal in Figure 25).

[0130] An example of a female connector element 2600 for receiving and securing a male connector element having a T-shaped configuration, such as, but not limited to, the male connector element 2500 of FIG. 25, is shown in FIGS. 26a-26d. FIGS. 26a-26d show the male connector element 2500 received and secured in the female connector element 2600. The female connector element 2600 includes a backing portion 2601 and an extension portion 2602 extending outwardly from the backing portion 2601. The extension portion 2602 has a plurality of hook-like extension members 2604 spaced apart from one another to form a pair of lateral slots 2606 and 2608. The lateral slots are positioned across one another at an angle corresponding to the traverse angle of the first and second portions 2501 and 2502 of the T-shaped body of the male connector element 2500.

[0131] Thus, the male connector element 2500 is aligned with and insertable into the lateral slots 2606 and 2608 of the female connector element 2600, securing the male connector element to the female connector element. In certain examples, one or both of the slots 2606 and 2608 are slightly smaller than the width of the first or second portions 2501 and 2502 of the T-shaped body of the male connector element. In such embodiments, the hook-like extension member 2604 may be flexible and resilient enough to receive the T-shaped body and apply a compressive force to the T-shaped body when received within the lateral slots 2606 and 2608, for example, to help retain or secure the male connector element 2500 to the female connector element 2600.

[0132] 26c and 26d, a clinician can add retention structures 2605, such as, but not limited to, O-rings, ligatures, or other suitable retention structures, onto the plurality of hook-like extension members 2604 of the extension portion 2602 of the female connector element 2600 after the T-shaped body of the male connector element 2500 is received into the female connector element. The hook-like extension members 2604 may include hooks or L-shaped ends that hold the O-rings, ligatures, or other suitable retention structures in place.

[0133] In a further example, the female connector element 2610 can be configured and operate similarly to the female connector element 2600 described herein, but further includes one or more clip structures 2612 that operate as self-ligating brackets, as shown in FIGS. 26e and 26f. The clip structure 2612 can be disposed on or clipped to one (or a pair) of the hook-like extension members 2604. In a particular example, the clip structure 2612 has a plate portion 2614 and a spring portion 2616, and is arranged so that the spring portion 2616 curves or is otherwise supported around the one or more hook-like extension members 2604. The plate portion 2614 is supported to partially cover one or both of the lateral slots by a sufficient amount to prevent removal of the T-shaped body of the male connector element 2600 when the T-shaped body is received within the lateral slot of the female connector element 2610. The spring portion 2616 provides sufficient flexibility and resilience when a sufficient outward force is applied to the plate portion 2614 to move the plate portion 2614 outward (away from) the extension portion 2604 a sufficient distance to allow removal (or insertion) of the T-shaped body of the male connector element 2600 from (or into) the lateral slot of the female connector element 2610. When the force is released, the plate portion 2616 resiliently retracts towards its original state (as shown in FIG. 26f).

[0134] FIG. 27a shows another example of a male connector element 2700 having an annular (e.g., rounded) shaped configuration that can be used with the embodiments described herein as an alternative to the other male connector elements described herein. The corners of the annular shape of the male connector element 2700 are rounded for patient comfort. In other examples, the shape of the male connector element may have squared corners. The male connector element 2700 of FIG. 27a has an annular body structure 2702 at the end of an arm of the instrument (the spring portion of the arm is shown in FIGS. 27a and 28). In other examples (consistent with the first embodiment), the male connector element 2700 may be provided on an arch-shaped bar of the instrument (rather than at the end of an arm). In the illustrated example of FIG. 27a, the annular body structure 2702 has a generally rectangular shape with a central opening 2704. In other examples, the annular body structure 2702 may have other suitable shapes, including other polygonal, elliptical, circular, or combinations of polygonal and elliptical or circular portions. In other examples, such as, but not limited to, the example of male connector element 2701 shown in Figure 27b, the body structure 2703 may be open at a corner, bottom, right side, or left side in the orientation shown (and therefore partially, not completely circular). In the example of Figure 27b, the body structure 2703 is open at a corner (the upper left corner in the orientation shown). Male connector elements 2701 that are open at a corner, bottom, or side may be easier to form by cutting from a 2D sheet of material compared to connector element 2700 having a closed circular shape.

[0135] The male connector element 2700 or 2701 shown in FIG. 27a or 27b can be configured to engage and secure with a female connector element having a configuration similar to that of the female connector element 2610 described herein. Alternatively, the male connector element 2700 or 2701 can engage and secure with a female connector element configured similarly to the female connector element 2610, but the female connector element may not include a slot (i.e., it does not have the vertical slots between the extension members 2604 of FIG. 26a), and therefore can engage and secure with a female connector element having a conventional (or more general) configuration. An example of a male connector element 2700 engaged and secured with a female connector element 2610 is shown in FIG. 28. Upon engagement, a portion of the annular body structure 2702 of the male connector element 2700 is inserted between the plate portion 2614 of the clip structure 2612 and the backing portion 2601 of the female connector element 2610, as shown in FIG. 28. Another portion of the female connector element 2610 aligns the male connector element with the female connector by fitting within and aligning with the central opening 2704 of the annular body structure 2702 when the male connector element 2700 is secured (or remains secured) to the female connector element 2610, as shown in Figure 28. In this manner, the male connector element 2700 can engage and secure a self-ligating female connector element or bracket.

[0136] Various examples and configurations of male connector elements and associated female connector elements can be used in various implementations of the second embodiment (and various implementations of the first embodiment) described herein. Particular examples of devices according to the second embodiment include the male connector element described and illustrated with reference to FIGS. 1-3, 5, and 6 (for securing a female connector element as described with reference to FIG. 7). Another exemplary device according to the second embodiment includes a male connector element (for securing to a female connector element as described with reference to FIG. 13) as described and illustrated with reference to FIGS. 8-12h. Yet another device according to the second embodiment includes a male connector element as described and illustrated with reference to FIG. 15a (for securing to a female connector element as described with reference to FIG. 15b and shown in FIG. 15c). Yet another device according to the second embodiment includes a male connector element as described and illustrated with reference to FIG. 16a (for securing to a female connector element of FIG. 16b shown in FIG. 16c). Yet another device according to the second embodiment includes a male connector element (for securing to a female connector element described with reference to FIG. 17b) as described and illustrated with reference to FIG. 17a. Another exemplary device according to the second embodiment includes a male connector element (for securing to a female connector element described with reference to FIGS. 26a-26f) as described and illustrated with reference to FIG. 18e, FIG. 18f, and FIG. 25. Another exemplary device according to the second embodiment includes a male connector element as described with reference to FIG. 27a and FIG. 27b (for securing to a female connector element as described with reference to FIG. 28). Yet another device according to the second embodiment includes a male connector element having other suitable configurations for securing to a female connector element having other suitable configurations.

[0137] A system or method according to the second embodiment allows a clinician to move each tooth independently by using one or more appliances having a separate arm connected to each tooth to be moved. The arms, including their spring members, provide a force-generating element that applies sufficient force to the tooth to move it from its OTA to the desired FTA. In certain instances, the arms can move the tooth in one or more (or all three) translational directions. Alternatively or additionally, the arms can move the tooth in one or more (or all three) rotational directions.

[0138] One or more of the shape, thickness, width, or length of each arm may be designed and configured to provide the appropriate force or torque (or both) to achieve the desired movement of the tooth. Furthermore, one or more of the shape, thickness, width, or length of each arm may be designed and configured to correspond to the size and type of tooth to which the arm is connected. For example, one or more of the shape, thickness, width, or length of the arm may be designed and selected to provide a greater amount of flexibility when the tooth is displaced a greater distance or when the tooth is smaller in size, such as, but not limited to, a lower incisor.

[0139] In certain instances, a processing and software system with finite element analysis capabilities is used to determine the desired geometry (size, shape, width, thickness, length) of the spring or arm (or both) to apply the desired or ideal force to accelerate the desired tooth movement.

[0140] The cross-sectional shape of the appliance according to the second embodiment can be configured to connect to some but not all of the teeth in a jaw, for example, to move a small number of teeth without damaging other teeth. In this case, the number of arms in the appliance can be significantly less than the number of teeth in a given jaw, but the number of arms can match the number of teeth the clinician wants to move. In other examples, one or more arms can be connected to one or more respective teeth to secure the appliance, without necessarily moving the teeth to which they are connected. In such examples, one or more arms that are connected to secure but not move teeth can be made relatively strong or thick for sufficient anchoring support. Some examples of uses for the cross-sectional shape of the appliance according to the second embodiment include, but are not limited to, opening spaces for implants, aligning tilted teeth in extraction spaces, and non-comprehensive orthodontic treatment for patients with only a few malaligned teeth. Another example of the cross-sectional shape of the appliance according to the second embodiment includes a molar positioning portion, as described with reference to FIG. 14.

[0141] The appliance 1400 of Figure 14 is configured as a molar positioner for use on the upper molars of a patient having, for example, improper intra-arch or inter-arch molar relationships. The appliance 1400 of Figure 14 includes an arched bar 1402 forming two arms 1404 and 1406 joined to a central portion of the bar 1402. The arched bar 1402 is configured to cross the patient's palate as a transpalatal arch (TPA) when the appliance 1400 is placed on the patient's teeth.

[0142] Each arm 1404 and 1406 extends from a central portion of the bar 1402 to an end segment at which a male connector element is located. The device 1400 includes a first male connector element 1408 formed on or attached to the end segment of the arm 1404 and a second male connector element 1410 formed on or attached to the end segment of the arm 1406. In the example shown in FIG. 14 , the device 1400 also includes first and second spring structures 1412 and 1414, with the spring structure 1412 formed on the arm 1404 or connected between the end of the arm 1404 and the male connector element 1408 and the spring structure 1414 formed on the arm 1406 or connected between the end of the arm 1406 and the male connector element 1410.

[0143] Spring structures 1412 and 1414 can be configured similarly to the configurations of spring elements (or combinations of spring elements) described herein. Male connector elements 1408 and 1410 are shown in Figure 14 as having a configuration similar to the example male connector elements for engaging female connector elements described with respect to any of the examples in Figures 8-12g, including, but not limited to, Figure 13. However, in other examples, the male connector elements 1408 and 1410 may have other suitable configurations, such as, but not limited to, those described herein with reference to Figures 1-3, 5, 6, 8-12h, 15a, 16a, 17a, 18c-18f, 25, 27a, and 27b, for engaging and securing with the female connector elements described herein with reference to Figures 7, 13a, 13b, 15b, 15c, 16b, 16c, 17b, 26a-f, and 28.

[0144] The appliance 1400 of FIG. 14 includes one or more (three in FIG. 14 ) anchor holders 1416. Each anchor holder 1416 may be configured and operative similarly to those described herein with reference to FIGS. 8 and 10 , or may be of other suitable configurations. In certain examples, one or more TADs or other suitable anchors are used to secure the appliance 1400 (via the anchor holders 1416) to the roof of the patient's palate. Additionally, the male connector elements 1408 and 1410 may be secured to female connector elements that are pre-bonded to the surfaces of the upper molars on opposite sides of the patient's jaw.

[0145] The appliance 1400 may be configured to apply appropriate forces to the molars to reposition them, for example, to obtain a desired or ideal internal arch and internal occlusion relationship. The final positions of the molars can be determined by selecting the locations of the TADs that can be accurately implanted using the guide tray.

[0146] In a further example, the molar positioner described with reference to Figure 14 can be used in mixed dentition to create space for the premolars and canines without any other teeth in the jaw.

[0147] The second embodiment device and the associated female connector element of the first embodiment are fabricated by any suitable method, including, but not limited to, molding, casting, machining, 3D printing, stamping, extrusion, etc. However, in certain examples, the second embodiment device or the female connector element (or both) are fabricated by cutting the 2D shape of the device from a 2D sheet of material and bending the 2D shape into the desired 3D shape of the device. This method, described later in this specification, is particularly suitable for fabricating the first and second embodiment device examples described herein. By cutting the 2D member from a flat sheet of material instead of a traditional single-diameter wire, a greater variety of 3D shapes can be fabricated compared to shapes made by bending a single-diameter wire. The cut 2D member may have a width and length designed or varied to allow for varying thickness, width, and length dimensions of portions of the 3D device when bent into a desired shape. In this manner, the 2D member can be cut to the desired thickness, width, and length of a spring member, arm, or other component of the device. Compared to bending a single diameter wire, bending custom-cut 2D parts allows for a greater variety of shapes to be achieved.

[0148] In certain examples, the device may be formed from cut 2D sheet material bent into a desired 3D shape, and the male connector elements may be configured to be fabricated from flat sheet material cut and / or bent into the desired shape of the male connector elements. FIG. 18e shows an example of a device 1800 according to an example of the second embodiment, formed from cut 2D sheet material bent into a desired 3D shape. In certain examples, the 3D shaped article may be shape-set by any suitable shape-setting procedure, such as, but not limited to, heat treatment. The example of FIG. 18e includes multiple male connector elements, each having a generally T-shaped configuration as described above. Each T-shaped male connector element is configured to engage and secure with a respective female connector element having, but not limited to, the configurations shown in FIGS. 26a-26f.

[0149] However, as another example, the device according to the second embodiment may be constructed from wire that is bent into a desired 3D shape. In a particular example, the wire is Nitinol. In other examples, the wire material may be any suitable material, such as, but not limited to, stainless steel, beta titanium, and shape memory alloys.

[0150] Various implementations of the second embodiment of the appliance can be configured to treat impacted teeth, such as, but not limited to, canines. For example, the appliance can be configured to move impacted teeth into the mouth by configuring the arms of the appliance to be secured to the impacted teeth and apply a force that retracts the teeth toward the patient's dental arch. In certain examples, the appliance includes one or more anchor holders for connecting to one or more TADs or other anchorage devices implanted in the patient to help apply a desired force or torque (or both) to the impacted teeth to move them to their final desired or ideal position. The appliance can be configured to be passive (applying no additional force or torque to the teeth) when the teeth are in their final positions, and active (applying force or torque, or both) in any other positions.

[0151] Therefore, compared to conventional braces, the appliance according to the second embodiment can be configured to apply appropriate force and torque to impacted teeth from the start of exposure, drawing them toward the patient's dental arch and rotating them in the appropriate direction to reach their final desired or ideal position. In contrast, orthodontic techniques using conventional braces may move teeth into the dental arch without torque control and require additional treatment to torque the teeth. Therefore, the example appliance according to the second embodiment can be configured to accelerate treatment time by simultaneously applying force and torque during treatment. Additionally, by using a TAD or TPA in the appliance examples described herein, a counterforce (of the force applied to the tooth) is applied to the TAD or TPA, minimizing the side effects of the counterforce. Appliances according to various examples can reduce treatment time, root resorption, and tooth movement, among other benefits.

[0152] <Third embodiment> As discussed above, a system or method according to the third embodiment may include or use an appliance similar in configuration to the first embodiment, but further configured to be selectively removable, allowing a patient (or clinician) to selectively place and remove the appliance from the patient's teeth. The appliance according to the third embodiment includes a plurality of caps (such as, but not limited to, aligners, acrylic, or polymer caps) in place of the male connector elements described above. However, other features of the appliance according to the third embodiment may be configured and operate as described above with respect to the examples of the first embodiment (including, but not limited to, the examples shown in FIGS. 1-3, 5, 6, 16, and 17).

[0153] In the appliance according to the third embodiment, each aligner cap is configured to be secured to a respective tooth by fitting over and over the tooth. For example, the caps may be fabricated from a polymer, acrylic, or other suitable material that helps retain each cap on the patient's tooth. In certain instances, additional or alternative connector elements may be provided to assist in attaching one or more (or each) cap to a respective tooth.

[0154] In certain examples of the system and method according to the third embodiment, the cap may be configured to be secured to and retained on the tooth by engaging a natural undercut in the tooth surface or through an artificial undercut provided by a fixture or button secured to the tooth. These fixtures can be made of metal, polymer, ceramic, or other suitable material. In certain examples, the fixtures can be fabricated to have the same or similar color as the tooth to be less visible and more aesthetically appealing. Fixtures with the same or similar color as the tooth can be formed from materials such as, but not limited to, composite resins, polymers, or ceramics. In certain examples, the fixtures can be secured to the patient's teeth using a tray that assists the clinician in placing the fixtures in the desired positions.

[0155] In the third embodiment, each cap can be customized to a size and / or shape corresponding to the size and shape of the tooth for which it is intended to fit. Alternatively, the aligner caps can be configured for application to any patient or tooth (or group of patients or teeth) and are not customized for each tooth or patient. In some implementations of the third embodiment, each aligner cap may be separately connected to a support bar and not directly connected to any other caps for adjacent teeth. In other examples, one of the aligner caps (or each of multiple aligner caps) can be connected to two or more adjacent teeth, for example, to move a group of teeth in unison or to provide additional fixation. This allows the appliance according to the third embodiment significant flexibility for clinicians to complete treatments using fewer appliances.

[0156] As shown in FIG. 19c, an example of a device 1920 according to the third embodiment may include an arched structure 1902 (best shown in FIG. 19a) and a plurality of caps 1922. The arched structure 1902 includes a shaped support member made of any suitable material, such as, but not limited to, nitinol (NiTi), stainless steel, beta titanium, cobalt chromium, or other metal alloys, polymers, or ceramics. The arched structure 1902 may be formed into a desired shape using any suitable shape-forming procedure, including, but not limited to, the methods described herein for forming the device according to the first embodiment. In the example of FIG. 19c, the arched structure 1902 may have a configuration similar to the device shown and described with respect to FIG. 17a, or any other suitable configuration.

[0157] In certain examples, the arched structure 1902 of appliance 1920 is configured to conform to the arch of the patient's maxilla (e.g., as described with respect to the arched structures of appliances 100, 200, and 500). In other examples, the arched structure of the appliance is configured to conform to the arch of the patient's mandible (e.g., as described with respect to the arched structures of appliances 300 and 600). Some or all of the arched structure of the appliance according to the third embodiment may be fabricated from any suitable material, including, but not limited to, nitinol (NiTi), stainless steel, beta titanium, cobalt chromium or other metal alloys, polymers, or ceramics, and may be a single, integrally formed structure or multiple separately formed components connected together into a unitary structure.

[0158] A plurality of cap connector elements 1904 are formed on and attached to the arched structure of the third embodiment appliance at spaced locations along the length of the arched structure (in place of the male connector elements shown in the example appliances of FIGS. 1-3, 5, and 6). In the third embodiment appliance, one or more springs 1906 are provided between adjacent cap connector elements 1904 (and thus between adjacent aligner caps). In some examples of the third embodiment, one or more springs are provided between each cap connector element and each adjacent cap connector element. In other examples of the third embodiment, one or more springs are provided between some, but not all, pairs of adjacent cap connector elements. For example, a rigid portion of the appliance may be provided between one or some pairs of adjacent cap connector elements. In further examples, one or more springs may be provided between cap connector elements that are not directly adjacent to one another. Each spring is a force-generating element of the appliance. In certain examples, each spring is made of a flexible material, such as, but not limited to, a shape memory alloy, such as Nitinol.

[0159] Each cap connector element 1904 is configured to connect to and retain a respective separate cap 1922 relative to its respective cap connector element. In other examples, multiple caps may be connected to and retained by one or more (or each) individual cap connector elements. In further examples, one or more (or each) cap connector elements may each connect to and retain two or more caps. Thus, individual caps 1922 are connected within the arch-shaped member 1902 at spaced locations along the arch-shaped member, with each cap 1922 being separated (not directly connected) from adjacent caps. In this manner, caps on the appliance (and the teeth to which they are secured) can move separately and independently from other caps on the appliance (and the teeth to which they are secured) without having to restrain other caps on the appliance (and the teeth to which they are secured). In certain examples, the caps do not cover springs located between adjacent caps on the appliance. In certain examples, the caps for adjacent teeth may be configured and attached to the arch-shaped structure in positions that do not contact each other throughout the course of treatment. In a further example, an appliance may be comprised of one or more caps that fit over multiple teeth (or have multiple adjacent caps connected to one another), while one or more other caps of the appliance are separate and independent from the other caps of the appliance.

[0160] In an example of the appliance according to the third embodiment, each cap 1922 may include an aligner. In such an example, an ASICS® machine or other suitable thermoforming or vacuum forming machine may be used to attach each aligner cap to a respective cap connector element of the arched member.

[0161] In certain instances, the aligner can cover the entire appliance, for example, to provide more comfort to the patient. In such instances, a space or clearance may be formed between the spring and the aligner. In such instances, the patient's tongue only comes into contact with the smooth surface of the aligner, rather than the metal arms or bars of the appliance, providing additional patient comfort. The aligner can be trimmed manually or by other suitable machining or cutting methods (e.g., but not limited to, laser cutting, milling, etc.).

[0162] In other examples of appliances according to the third or fourth embodiments, instead of or in addition to the one or more male connector elements, the appliance may include other features for engaging and securing one or more of the patient's teeth. For example, the one or more engagement features may be configured to pass the lingual surface of the tooth over the incisal or interproximal surface and retain the tooth buccally (e.g., similar to clasps on a partial denture). In other examples, the one or more engagement features may be configured to pass the buccal surface of the tooth over the incisal or interproximal surface and retain the tooth lingually (e.g., similar to clasps on a partial denture).

[0163] In various examples of the systems and methods according to the third embodiment, the appliance may be configured such that the removable appliance cap is passive and does not apply force to the teeth to move them.

[0164] As with other embodiments described herein, the appliance according to the third embodiment can be designed and manufactured using computerized design and manufacturing techniques, such as, but not limited to, those described herein. The appliance according to the third embodiment can be configured to be resilient to a longer range of movement compared to conventional removable appliances. For example, the inclusion of spring elements between the caps and the use of separately connected caps (not directly connected to adjacent caps) allows for a greater range of movement than appliances that do not include spring elements or that use interconnected caps. As a result, the exemplary method according to the third embodiment requires fewer appliances to complete treatment compared to conventional removable appliances with stainless steel springs or compared to conventional aligner processes (such as, but not limited to, Invisalign® or ClearCorrect®).

[0165] Other examples of appliances according to the third embodiment can use any suitable combination of aligners on some teeth and clamps on other teeth. In such embodiments, the appliance may include one or more aligners at one or more corresponding tooth locations and one or more clamps at one or more other tooth locations in the patient's jaw. Alternatively, or in addition, different types of clamps can be used at different tooth locations on the appliance. For example, the flexibility of NiTi clamps on the rear molars can increase the retention ability of the appliance. This can be useful when a malocclusion requires stronger retention of the appliance against the teeth.

[0166] The appliance according to the third embodiment may include one or more palatal arch features or lingual arch features, including, but not limited to, for example, palatal arch features 202 or 804 of Figures 2 and 8, respectively, or lingual arch feature 302 of Figure 3.

[0167] An appliance according to the third embodiment may include one or more anchor holders for securing the appliance to the patient's palate or buccal shelf, as described herein with respect to anchor holder 812 or 904 in Figures 8 and 10. For example, one or more anchor devices (such as, without limitation, TADs) may be implanted in the patient's palate or buccal shelf, or other suitable location on the patient. A removable appliance according to the third embodiment may include one or more engagement mechanisms configured to engage and connect to the implanted anchor devices when the appliance is placed on the patient's teeth, and to selectively release from the implanted anchor devices to remove the appliance. In such embodiments, the engagement mechanisms may include one or more of a snap connector (for a snap connection to the implanted anchor device), a sliding connector (for a sliding connection to the implanted anchor device), or other suitable connector. Alternatively, or in addition, a platform may be secured to the patient's palate or buccal shelf, where the platform may include one or more snaps, slides, or other suitable engagement mechanisms for engaging and connecting with one or more snaps, slides, or other suitable engagement mechanisms on a removable appliance to selectively connect and disconnect the appliance from the platform. In further examples, any suitable bone fixation device may be used in place of or in addition to one or more TADs.

[0168] <Fourth embodiment> As noted above, a system or method according to the fourth embodiment includes or uses an appliance having a configuration similar to that of the second embodiment, but configured to be selectively removable, allowing a patient (or clinician) to selectively attach and remove the appliance from the patient's teeth. Like the second embodiment, the appliance according to the fourth embodiment has multiple separate arms configured to individually connect to corresponding teeth via caps, with each arm of the appliance configured to connect a different individual tooth to each of the other arms of the appliance. In other examples, one or more of the aligner caps (or each of multiple aligner caps) can be individually connected to two or more adjacent teeth, for example, to move a group of teeth in unison or to provide additional fixation.

[0169] Thus, various features of the appliance according to the fourth embodiment can be configured and operative as described above with respect to the examples of the second embodiment (including, but not limited to, the examples shown in FIGS. 8-12g). However, instead of the male connector elements of the second embodiment, the appliance according to the fourth embodiment includes a plurality of caps (such as, but not limited to, aligner caps, acrylic caps, or polymer caps). Each separate cap may be formed on or attached to a respective arm, e.g., at the end of each arm opposite the end attached to the arched bar of the appliance. The caps are configured to hold the appliance on the patient's teeth and maintain the appliance in a desired position during use.

[0170] The caps of the fourth embodiment are configured similarly to the caps described herein for the third embodiment and are secured to the patient's teeth by fitting snugly over the teeth and securing them to the patient's teeth. However, the separate caps of the fourth embodiment are attached to the ends of separate arms rather than directly to the arch structure of the appliance.

[0171] A system or method according to the fourth embodiment (where the appliance includes multiple separate arms configured to connect to corresponding teeth individually) can provide the distinct advantage of providing and controlling the movement of individual teeth. Such an advantage allows a clinician to reduce tooth relapse, thereby reducing treatment time, root resorption, and the number of visits a patient must make to the orthodontist. Thus, compared to certain conventional orthodontic techniques in which multiple teeth are connected to a single archwire, where moving one tooth can potentially cause unintended movement of nearby teeth, certain implementations described herein allow a clinician to control the movement of each tooth independently of each of the other individual teeth.

[0172] In various examples of systems and methods according to the fourth embodiment, the appliance may be configured to move the teeth until the removable appliance cap is passive and no longer exerts a force on the teeth. As with other embodiments described herein, the appliance according to the fourth embodiment may be designed and manufactured using computerized design and manufacturing techniques, such as, but not limited to, those described herein.

[0173] As with the third embodiment, various examples of appliances according to the fourth embodiment may include any suitable combination of aligners for some teeth and clamps for other teeth in the patient's jaw. In such embodiments, the appliance may include one or more aligners at one or more corresponding tooth locations and one or more clamps at one or more other tooth locations in the patient's jaw. Alternatively, or in addition, different types of clamps may be used at different tooth locations on the appliance. For example, the flexibility of NiTi clamps on the rear molars may increase the retention capacity of the appliance. This may be useful when a malocclusion requires stronger retention of the appliance against the teeth.

[0174] An appliance according to the fourth embodiment may include one or more palatal bow features or lingual archwire features, such as, but not limited to, palatal bow features 202 or 804 of Figures 2 and 8, respectively, or lingual archwire feature 302 of Figure 3. An appliance according to the fourth embodiment may include one or more anchoring device holders for securing the appliance to the patient's palate or lingual portion, such as described herein with respect to anchoring device holders 812 or 904 of Figures 8 and 10. In such an example, one or more anchoring devices (such as, but not limited to, TADs) may be inserted into and engaged and disengaged (and selectively connected and disconnected) from the patient's palate or lingual region, as described with respect to the third embodiment.

[0175] In certain examples of systems and methods according to the fourth embodiment, as described above for the third embodiment, the cap may be configured to be secured and retained on the tooth by engaging a natural undercut on the tooth surface or via an artificial undercut provided by a fixture or button secured to the tooth.

[0176] The arms of the appliance according to the fourth embodiment (similar to the appliance according to the second embodiment) may include one or more flexible elements, such as springs, that exert a force based on, for example, the size of the tooth and the desired movement of the tooth to which the arm is connected, and have selectable or customizable flexibility. In appliances according to examples of the fourth embodiment, a single respective cap is attached to each arm, and in certain instances, does not cover any portion of the flexible element of the arm or bar. In other instances, two or more caps are attached to an arm, or multiple arms are attached to multiple caps, or a combination thereof. Cap connector elements (e.g., similar to cap connector element 1804 described above) may be formed on or otherwise connected to the ends of individual arms, or may be connected to a single cap. In other instances, two or more cap connectors are connected to one of the caps, or multiple caps are secured to multiple cap connectors, or a combination thereof.

[0177] In certain instances, the caps are configured to attach to the patient's teeth in a manner that avoids contact between the caps for adjacent teeth. In this way, the caps on the appliance (and the teeth to which they are secured) can move separately and independently from the other caps on the appliance (and the teeth to which they are secured) without having to restrain the movement of the other caps on the appliance (and the teeth to which they are secured).

[0178] In an example of an appliance according to the fourth embodiment, each cap may include an aligner. In such an example, an Essix® machine or other suitable thermoforming or vacuum forming machine may be used to attach each aligner cap to a respective cap connector element on the arm of the appliance.

[0179] In certain instances, the aligner can cover the entire appliance, for example, to provide comfort to the patient. In such instances, a space or clearance may be formed between the springs on the arms and the aligner on the arms. In such instances, the patient's tongue only comes into contact with the smooth surface of the aligner, rather than the metal arms or bars of the appliance, providing additional patient comfort. The aligner can be trimmed manually or by another suitable machining or cutting method (such as, but not limited to, laser cutting, milling, etc.).

[0180] In another example, one or more arms can be configured to pass over the lingual surface of the tooth through the incisal or interproximal surfaces and hold the tooth buccally (similar to different shaped fasteners in a partial denture). In another example, the appliance according to the fourth embodiment includes a bar on the buccal side, and the arms pass over the tooth lingually with the tips of the arms in a removable appliance on the lingual side.

[0181] Systems or methods according to the third and fourth embodiments (where the appliances include multiple aligner caps configured to fit snugly over the teeth and be secured to the patient's teeth) can provide the distinct advantage of appliances that can be easily removed by the patient or clinician in a manner similar to that used with conventional clear aligners.

[0182] How to Make and Use the Embodiments Systems and methods according to embodiments described herein can be used to move or reposition teeth using one appliance or by using several appliances incrementally depending on, for example, the complications of a dental malocclusion.

[0183] According to various examples and embodiments described herein, appliances can be constructed and used in techniques that can achieve translational orthodontic tooth movement in one or more (or all three) spatial directions (i.e., mesio-distal, buccolingual, and occlusal-gingival). Alternatively or additionally, such appliances can be constructed and used in techniques that can achieve rotational movements, such as torque, angulation, and rotation (i.e., buccolingual root torque, mesio-distal angulation, and mesio-external rotation).

[0184] An example of a method 2000 for making and using a device according to various examples and embodiments described herein is described with reference to FIG.

[0185] The method 2000 of FIG. 20 includes obtaining (2002) data representing a three-dimensional OTA of a patient's jaw. The three-dimensional OTA data may include digital image data obtained, for example, by using an intraoral scanner on the patient or by using an extraoral scanner on plaster casts of the patient's upper and lower dental arches. In other examples, the three-dimensional OTA data may be obtained from other suitable devices and methods, such as, but not limited to, imaging of tooth placement by cone-beam computed tomography scanning (CBCT) or magnetic resonance imaging (MRI). In examples using plaster casts, the relationship between the teeth in the upper and lower arches (inter-arch relationship) may be obtained by taking a wax bite of the patient in a central position. In intraoral scanning examples, the inter-arch relationship may be recorded by the scanner.

[0186] The 3D digital images of the teeth obtained from the three-dimensional OTA data are cut into individual tooth or multi-tooth blocks (one or more digital images of individual teeth) (2004). The 3D digital images can be cut and manipulated using an appropriate processing and software system, such as, but not limited to, a processing device running computer-aided design (CAD) software. The processing device may include any suitable computer system, mainframe, desktop computer, laptop computer, computer network device or system, mobile electronic pad or communication device, etc., capable of operating as described herein.

[0187] Using a processing device and appropriate software, digital images of individual teeth are moved to a desired or preferred intra-arch and inter-arch arrangement, e.g., based on a clinician's prescription (2006). For example, one or more (or all) teeth from the upper or lower jaw (or both) are moved until their cusps are in good alignment and interdigitate. The desired or optimal arrangement of the teeth within the jaw can be identified as the FTA for the patient. In certain instances, a qualified clinician may approve the realignment after a 3D digital FTA is obtained from the 3D digital OTA.

[0188] The processing system interpolates tooth movement from the 3D digital OTA to the 3D digital FTA (2008). In examples where multiple appliances are used incrementally during treatment to reach one or more stages of the ITA before reaching the FTA, the processing system interpolates tooth movement from the 3D digital OTA to one or more stages of the ITA and from the ITA to the FTA. In other examples, a clinician may select an FTA or ITA without using computerized interpolation, for example, based on the clinician's experience and knowledge, predetermined guidelines, or a combination thereof.

[0189] The processing system determines (2010) a three-dimensional appliance configuration based on the interpolated movement of the teeth between the OTA and the FTA (including any ITAs). The processing system calculates (or uses calculations) the forces and torques required to move each tooth from the OTA to the FTA and any ITAs. The processing system also calculates (or uses calculations) the forces and torques applied by the appliance dimensions and configuration, and, based on these calculations, designs or determines an appropriate appliance configuration that applies the forces and torques required to move each tooth from the OTA to the FTA and any ITAs. By determining the appropriate thicknesses, widths, and configurations for springs, arm bars, and other components of an appliance according to one or more of the first, second, third, and fourth embodiments described herein, an appliance configuration is determined that can apply forces and torques to the appropriate teeth to move them to the FTA or ITA. An appliance configuration is determined for the FTA, and a separate appliance configuration is determined for each ITA. The processing system provides data corresponding to each appliance configuration.

[0190] In certain instances, the design of the appliance can be performed by a clinician, manufacturer, or engineer using a processor system and appropriate design software, such as, but not limited to, CAD software, for example, SolidWorks®, Autodesk® Inventor, Creo®, etc. FEA software, such as, but not limited to, Abaqus, Ansys, etc., may be used to design the springs and arms to apply the desired or optimal force to the teeth. For example, with respect to the first and third embodiments, such software and processing system can be used to design and modify the thickness, cutting width, length, and overall shape of each interdental spring based on the desired movement of the tooth to which the spring is connected.

[0191] With respect to the second and fourth embodiments, such software and processing systems can be used to design and modify the thickness, cutting width, length, and overall design of each arm based on the movement of the tooth to which it is connected. For example, if a tooth needs to be displaced a longer distance or if the tooth is smaller (e.g., lower lateral incisors), the spring or arm can be designed to be more flexible. Also, if necessary, the spring / arm can be designed to apply a smaller force to some or all of the teeth to address periodontal issues such as bone resorption, root resorption, or attachment loss. The ability to customize the force or torque (or both) applied to each tooth can provide a significant advantage over traditional orthodontic applications.

[0192] Based on the data provided by the processing system, one or more appliances are manufactured (2012). The processing system may be connected to provide design data corresponding to the appliance configurations to one or more manufacturing or manufacturing systems to manufacture one or more appliances (or components of one or more appliances) configured to control the one or more manufacturing or manufacturing systems to provide forces and torques that move each tooth from the OTA to the FTA and any ITA. The processing system may be connected to the one or more manufacturing or manufacturing systems directly, for example, via an electronic network or other digital connection, or indirectly, for example, by storing data from the processing system on a non-transitory storage medium and distributing the storage medium to the one or more manufacturing or manufacturing systems.

[0193] The process according to FIG. 20 may be used to manufacture one or more appliances according to embodiments described herein. Each appliance can be placed on a patient's teeth to move the teeth from the OTA to the FTA (or to the ITA, or from the ITA to the FTA or another ITA) as described herein. The appliances can be designed to treat a variety of dental malocclusions treatable in traditional orthodontic settings. Furthermore, systems and methods including appliances according to embodiments described herein can be configured to shorten typical treatment times, shorten seating times, reduce the number of clinician visits, and reduce the complexity of the clinician's procedures. Another advantage of the embodiments described herein is that appliances according to these embodiments can be configured to be placed behind the teeth, if desired, e.g., to be as invisible as possible from the outside. The embodiments described herein are adaptable to changes in a patient's teeth that may occur as part of the treatment process. For example, a clinician may extract one or more teeth from a patient as part of treatment due to a lack of space for all teeth to fit into the arch (or for other reasons). In such cases, the extracted teeth can be erased from the 3D digital image used in the calculations described above. If the clinician determines that there is not enough space and that the teeth need to be made smaller, the patient can undergo interproximal reduction (IPR), in which the teeth can be removed and reduced in size on the 3D digital image to match the IPR performed by the clinician.

[0194] In the first and second embodiments described herein, the fabricated appliance is configured to be placed on the patient's teeth by engaging a male connector element on the appliance with a female connector element bonded to the tooth. In such embodiments, a clinician can use 3D digital OTA to select the position and size of the female connector element (bracket). In certain instances, the female connector element can be selected or customized to the geometry of the tooth surface to precisely fit over the tooth surface. One option is to bond the female connector element to the posterior (lingual) side of the tooth, for example, to make the appliance more aesthetically appealing. Another option is to bond the female connector element to the anterior (buccal) side of the tooth. The buccal type may be preferred in orthognathic surgery, where the surgeon can benefit from easier access to the appliance during surgery. However, even in orthognathic surgery, the lingual type can be used. In this case, the female connector element may be placed buccally before surgery and then removed, for example, within a few weeks of surgery.

[0195] The customized tray may be indirectly bonded to the female connector elements on the tooth surfaces using a 3D digital OTA. The clinician can use the customized tray to attach the female connector elements to the tooth surfaces with composite resin or other bonding materials. The tray can assist the clinician in bonding the brackets to the teeth in the optimal position. If necessary, another customized tray may be fabricated using the OTA to assist the clinician in implanting a temporary anchorage device (TAD) in the optimal position. For patient comfort, the clinician may anesthetize the desired insertion location before using the tray as a guide to insert the TAD. If additional anchorage is required for tooth movement, a TAD is placed. The use of a TAD is determined by the clinician and the selected treatment plan. If necessary, additional stabilization can be achieved by including a palatal arch in the maxillary appliance or a lingual arch in the mandibular appliance.

[0196] Alternatively, the clinician may attach the female connector element directly to the tooth without the aid of a tray. Similarly, the clinician may insert a TAD into the jaw without the use of a guide tray. In that case, after manually positioning the female connector element or TAD, an intraoral scan, cone beam computed tomography (CBCT), or other suitable scan or image may be taken of the patient. The appliance is then fabricated or manufactured based on the clinician-selected location of the female connector element or TAD.

[0197] For appliances according to the third and fourth embodiments, a clinician can use a 3D digital OTA to select the position and size of each cap and the attachment elements. The caps and attachment elements can be customized to the geometry of the tooth surface to precisely fit the tooth surface. In some instances, the attachments are attached to the back side of the tooth (lingual side of the tooth), which makes the appliance more aesthetically appealing. In other instances, the attachments are attached to the front side of the tooth (buccal side of the tooth). The buccal type may be preferred in orthognathic surgery, where the surgeon can benefit from easier access to the appliance during surgery. However, it is possible to use the lingual type even in orthognathic surgery. In this case, the attachments may be placed on the buccal side before surgery and then removed, for example, within a few weeks of surgery.

[0198] Customized trays may be created using 3D digital OTAs for indirect bonding of appliances to tooth surfaces. Clinicians can use customized trays to attach appliances to tooth surfaces using composite resin or other bonding materials. The trays can assist clinicians in bonding appliances in the desired or optimal position. If needed, another customized tray can be created using the OTA to allow clinicians to insert temporary anchorage devices (TADs) in the desired or optimal position. For patient comfort, clinicians may anesthetize the desired insertion location before using the tray as a guide for TAD insertion. These TADs are placed when tooth movement requires additional fixation. The decision to use TADs is made by the clinician and the selected treatment plan. If needed, additional stabilization can be achieved by including a palatal arch in the maxillary appliance or a lingual arch in the mandibular appliance.

[0199] Alternatively, the clinician can attach the attachments directly to the teeth without the aid of a tray. Similarly, the clinician may insert a TAD into the jaw without the use of a guide tray. In that case, after the female connector element or TAD is manually placed, an intraoral scan, CBCT, or other suitable scan or image can be taken of the patient. The appliance is then fabricated or manufactured based on the attachment or TAD location selected by the clinician.

[0200] In the first and second embodiments, after each appliance is fabricated and the female connector elements are attached to the teeth, each male connector element on the appliance engages its associated female connector element to install the appliance. Once installed, the appliance applies force and torque to the teeth to move them to the desired FTA or ITA. After each stage of treatment is completed (OTA to FTA, OTA to ITA, ITA to ITA, or ITA to FTA), the male connector element passively seats in the female connector element and no further force is applied to the teeth. At that stage, the male connector element may be removed and the next appliance installed using the same female connector element. However, if the previous appliance was an FTA-based appliance, then the treatment is complete. Based on the clinician's input, one or more appliances may be constructed and installed to allow for finishing, detailing, and final micropositioning of the teeth.

[0201] In the third and fourth embodiments, after each appliance is fabricated, each cap of the appliance can be engaged with the appropriate tooth or teeth, in some instances with the aid of a fixture. Once seated, the appliance applies force and torque to the teeth to move them to the desired FTA or ITA. After each stage of treatment is completed (OTA to FTA, OTA to ITA, ITA to ITA, or ITA to FTA), the cap passively seats on the tooth and no longer applies force to the tooth. At that stage, the cap is removed and the next appliance is inserted into the patient's mouth. However, if the previous appliance was built based on the FTA, then the treatment is complete. Based on the clinician's opinion, one or more appliances may be constructed and placed to allow for finishing, detailing, and final micropositioning of the teeth.

[0202] The devices according to the first and second embodiments and their associated female connector elements can be manufactured by any suitable method, including, but not limited to, molding, casting, machining, 3D printing, stamping, extrusion, etc. For example, a 3D metal printer can be used to directly print the device from nitinol, steel, beta-titanium, or other suitable metals or alloys. In another example, the device is first printed from a castable wax, and then the wax pattern is investment cast into nitinol, steel, beta-titanium, among other metals or alloys. In another example, the device is directly printed from a polymer or elastomeric material.

[0203] However, in certain embodiments, the device or female connector element (or both) of the various example embodiments described herein are fabricated by cutting the 2D shape of the device from a 2D sheet of material and bending the 2D shape into the desired 3D shape of the device. Such a method is particularly suited to the manufacture of devices according to the first and second example embodiments described herein, or the arched structures or metal portions of devices according to the third and fourth example embodiments described herein.

[0204] Thus, a method of fabricating an appliance according to any suitable exemplary embodiment described herein, and in certain examples, a method of fabricating an appliance according to embodiments described herein, includes designing an appliance configuration using suitable processing and hardware systems, for example, with reference to method 2000 as described herein, wherein fabricating one or more appliances (2012) includes cutting a 2D shape of the appliance from a 2D sheet material and bending the 2D shape into a desired 3D shape of the appliance.

[0205] More specifically, with reference to Figure 21, an example method of fabrication 2100 (corresponding to function 2012 of method 2000) includes creating 2102 a 3D image or template based on the 3D configuration determined in 2010 of method 2000. The image or template of the instrument can be designed by a clinician, manufacturer, or engineer using a processing system and suitable design software, such as, but not limited to, CAD software, for example, but not limited to, SolidWorks®, Autodesk® Inventor, Creo®, etc. An example of a 3D template 1800 of an instrument designed in SolidWorks® and Autodesk® Inventor is shown in Figure 18a.

[0206] The method 2100 includes converting 2104 the 3D image or template into a 2D image or template. Such conversion can be performed using a processing system and suitable flattening software, such as, but not limited to, ExactFlat® or other suitable software. Figure 18b shows an example of the template 1802 of the 2D image or 3D template of Figure 18a.

[0207] A 2D representation of the instrument is then formed 2106 from and based on the 2D image or template using a processing system and appropriate software, such as, but not limited to, CAD software, including, but not limited to, SolidWorks®, Autodesk® Inventor, Creo®, etc. FIG. 18c shows an example of a 2D representation 1804 of the instrument based on the 2D image or template of FIG. 18b. In certain examples, the 2D representation may include one or more temporary arms 1806 used to secure the instrument to a mandrel during a bending or hardening (heat treatment) procedure. In further examples, the 2D representation may include one or more fixture holders, such as, but not limited to, those described herein.

[0208] The data corresponding to the 2D representation of the instrument is then provided 2108 to a suitable fabrication device (such as, but not limited to, one or more machines for cutting, laser cutting, milling, wire EDM, water jetting, stamping, etc.) to cut a flat sheet of material into a member having the 2D shape of the 2D representation of the instrument. The fabrication device is controlled by the data to fabricate a 2D member having the shape of the 2D representation of the instrument. The 2D member can be cut 2110 from a flat sheet of any suitable material, such as, but not limited to, nitinol, stainless steel, cobalt chrome, or other types of metal. In a particular example, the flat sheet of material is a sheet of nitinol (NiTi), and the 2D member cut from the flat sheet has the shape of the 2D representation of the instrument in nitinol (NiTi). FIG. 18d shows an example of a 2D member 1808 fabricated based on the 2D representation 1804 of FIG. 18c. In the example where a temporary arm 1806 is added, the temporary arm may be omitted from the 2D member (or may be included in the 2D member and subsequently cut or removed).

[0209] After cutting the 2D member from a flat sheet of Nitinol (NiTi) or other suitable material, the method includes bending 2112 the 2D member into a desired 3D shape corresponding to the 3D image or template from which the 2D member was fabricated. In certain examples, one or more mandrels are configured for use in bending the 2D member into the desired 3D shaped configuration. In such examples, after cutting the 2D member, the 2D member is secured onto or between one or more mandrels. The 2D member is bent onto or between the mandrels to form the desired 3D shape. FIG. 18e shows an example of an instrument 1810 having a 3D shape formed by bending the 2D member 1808 of FIG. 18d into a desired shape.

[0210] During or after the bending operation, the 3D shape may be subjected to one or more shape-setting procedures 2114, such as, but not limited to, heat treatment, to set the desired 3D shape. Shape-setting procedures involving heat treatment may include heating the member during or after bending followed by rapid cooling.

[0211] One example of a heat treatment procedure involves heating the component (during or after bending into the desired 3D shape) to a selected temperature (e.g., but not limited to, 550°C) for a selected time (e.g., but not limited to, 10 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 vary from those described above, for example, based on the particular treatment regimen. For example, the heat treatment temperature may be in the range of 200°C to 700°C, and the heat treatment time may be up to about 120 minutes. In certain examples, the heat treatment procedure may be performed in an air or vacuum furnace, a salt bath, a fluidized sand bed, or other suitable system. After completing the heat treatment, the tool has the desired 3D shape and configuration. In other examples, other suitable heat treatment procedures may be employed, including, but not limited to, resistance heating or heating by passing an electric current through the metal of the tool structure. The 3D printed article may be subjected to one or more additional, e.g., post-processing, operations, including but not limited to, polishing, electropolishing, electroplating, coating, sterilization, or other cleaning or decontamination procedures.

[0212] As mentioned above, FIG. 18e shows an example of an instrument 1810 having a 3D shape formed by bending the 2D member 1808 of FIG. 18d into a desired shape. Another example of an instrument 1820 having a 3D shape formed by bending a 2D member into a desired shape is shown in FIG. 18f. The exemplary instrument 1820 of FIG. 18f includes multiple arms having male connector elements 1822, similar to the male connector element 1802 of the instrument 1810 of the example of FIG. 18e. However, the springs 1824 on the arms of the instrument 1820 have a different shape than the springs on the arms of the instrument 1810. Additionally, the instrument 1820 has a TAD retaining portion 1826 having a generally U-shaped or Y-shaped configuration, compared to the annular or O-ring shape of the TAD holder of the instrument 1810 in the example shown in FIG. 18e. The instrument 1820 of FIG. 18f can be fabricated in a manner similar to the method for making the instrument 1810 described herein.

[0213] In examples where the appliance is comprised of multiple components, some (or each) component of the appliance may be fabricated according to the methods described above (including, but not limited to, methods 2000 and 2100) and then connected together to form the desired 3D appliance configuration. In these or other examples, the appliance (or some or each component of the appliance) may be fabricated by other suitable methods, including, but not limited to, directly printing metal, first printing a wax element and then investment casting the wax element into metal or other material, printing an elastomeric material or other polymer, or cutting components from a metal sheet and setting the shape into the desired 3D configuration.

[0214] As described herein, one or more mandrels can be used to bend the cut 2D members into a desired 3D configuration. In certain examples, one or more mandrels (such as, but not limited to, custom-made) are provided for each jaw of a patient. For example, the mandrels can be customized in shape and configuration for each patient and can be fabricated by any suitable method, including molding, machining, direct metal printing of stainless steel or other suitable metals, or 3D printing of suitable materials, such as, but not limited to, steel / copper mixes via binder jetting, as well as first printing the wax configuration and then investment casting the wax into various metals. In various examples described herein, the mandrels can be constructed of a material that is sufficiently resistant to the temperatures of the heat treatment. In certain examples, one or more robots can be used, with or without one or more mandrels, to bend the cut 2D members into a desired 3D configuration.

[0215] By using cut 2D members instead of traditional single-diameter wire, a greater variety of three-dimensional shapes can be fabricated compared to shapes created by bending single-diameter wire. The cut 2D members may be designed or varied in width and length so that, when bent into a desired shape, the thickness, width, and length dimensions of a portion of a 3D instrument can be varied. In this manner, the 2D members can be cut to the desired thickness, width, and length of a spring member, arm, or other component of an instrument. Compared to bending single-diameter wire, bending custom-cut 2D members allows for a greater variety of shapes to be achieved.

[0216] As described above, the method 2100 for creating 3D instrument configurations from cut 2D members is particularly suitable for fabricating the metal components of instruments according to the first and second embodiments, or the third and fourth embodiments. In certain examples, the entire instrument (including the male connector elements and springs) is constructed by bending the cut 2D members into the desired 3D shaped member. In other examples, additional components can be attached to the 3D shape, for example, after bending 2112; such additional components may include, but are not limited to, male connector elements (e.g., but not limited to, those shown in FIG. 12 ), spring elements, arms, cap connector elements, TAD holders, etc. Such additional components may be attached to the 3D shaped member by any suitable attachment mechanism, including, but not limited to, adhesive materials, welding, friction fitting, etc.

[0217] Similarly, the metal portions of the appliances according to the third and fourth embodiments can also be fabricated from cut 2D pieces using methods 2000 and 2100 described herein. Once the metal portions of the appliance are constructed (cut from 2D sheet material and bent into the desired 3D shaped member), one or more caps can be attached to attachment elements formed on (or attached to) the metal portions. In certain examples, the caps may be constructed and attached to the 3D shaped member so that caps for adjacent teeth do not contact each other during treatment. In such examples, an Essix® machine or other suitable thermoforming or vacuum forming machine can be used to attach each cap to a respective cap connector element on the 3D shaped member.

[0218] Additional components may be attached to the 3D shaped member, for example after bending (2112), and such additional components may include, but are not limited to, male connector elements (such as, but not limited to, those shown in FIG. 12), spring elements, arms, cap connector elements, TAD holders, etc. Such additional components may be attached to the 3D shaped member by any suitable attachment mechanism, including, but not limited to, adhesive materials, welding, friction fitting, etc.

[0219] The caps may be configured and connected to the 3D shaped member with sufficient clearance between adjacent caps to allow movement of the springs and arms. In a further embodiment, the aligner caps are configured to cover only the teeth, and the aligner can be trimmed manually or by another cutting method described herein.

[0220] A further method for manufacturing an appliance according to the third embodiment is described and illustrated in FIGS. 19a-19c. Referring to FIG. 19a, a 3D printed model or mold 1900 of a patient's ITA or FTA is generated according to procedures described herein. The model or mold 1900 can be made of any suitable polymer, ceramic, metal, etc. In a further example, the mold may include a larger portion of the patient's palate than shown in FIGS. 19a-19c. Additionally, an arched structure 1902 is fabricated from metal or other suitable material according to procedures described herein for manufacturing the appliance of the first embodiment. In one example, the arched structure 1902 has a shape and configuration similar to the appliance of FIG. 17a and is manufactured as described herein. In other examples, arched members having other suitable shapes can be used. The arched structure 1902 is placed on or attached to the model or mold, as shown in FIG. 19a, by any suitable attachment mechanism, including, but not limited to, adhesive, ligatures, etc.

[0221] The thermosetting material is then pressed into the model or mold 1900, for example, using an Essix® machine or other suitable thermoforming or vacuum forming machine, while the arched structure 1902 resides in the model or mold, such that the arched structure becomes embedded in the thermosetting material. In a particular example, the thermosetting material is a thermosetting plastic, such as, but not limited to, Essix® plastic sheet, having a thickness of up to about 2 mm.

[0222] In another example, one or more layers of thermosetting material are pressed against the model or mold 1900 before the arched structure 1902 is placed on the model or mold. The arched structure 1902 is then placed on top of the thermosetting material (before or after the thermosetting material is set to the shape of the model or mold). One or more additional layers of thermosetting material are then placed on top of the arched structure 1902 and the previously placed thermosetting material and set to the shape of the model or mold. Thus, the arched structure 1902 may be secured between two or more layers of thermosetting material formed to the shape of the model or mold. In certain embodiments, the thermosetting material is cut or removed (before or after heat setting) in areas covering spring members or other flexible portions of the arched members or arms extending from the arched members to minimize or eliminate any interference with the movement or flexibility of the spring members or flexible portions.

[0223] Once sufficiently hardened, the thermosetting material (including the arch-shaped members) is removed from the model or mold 1900. Once removed from the model or mold, the molded plastic (and the arch-shaped structures embedded in the molded plastic) form a three-dimensional structure 1910 of a full jaw cap of teeth, as shown in FIG. 19b. The molded plastic structure 1910 is then cut by forming incisions between each pair of adjacent teeth to form the appliance 1920, as shown in FIG. 19c. Such cutting may be performed by any suitable cutting procedure, such as, but not limited to, milling, laser cutting, etc. While various materials can be used in example appliances according to embodiments described herein, a particular example is one made from a shape memory alloy, such as nitinol (NiTi), which contains nickel and titanium. Nitinol has sufficient elasticity and shape memory properties. Therefore, by using nitinol, forces applied to the teeth can decay more slowly than the force generators of traditional braces. Thus, systems and methods according to embodiments described herein may be configured to require fewer appliances (thus simplifying treatment) compared to traditional orthodontic disciplines and techniques.

[0224] During some treatment procedures, clinicians may perform extractions for a variety of reasons, including overlapping teeth due to their relative size in the patient's jaw, damaged teeth requiring extraction, or other reasons. When an extraction is performed, adjacent teeth that were not extracted tend to move toward each other to close the extraction space. Certain systems and methods (including appliances) according to embodiments described herein may be used to close extraction spaces asymmetrically, referred to as minimal / maximal fixation, or symmetrically, referred to as moderate fixation. In certain instances, TADs may also be used to provide fixation for closing the extraction space. In such instances, one or more TADs may be positioned to hold a passive appliance on one side of the extraction space to close the space asymmetrically. Alternatively, one or more TADs may be positioned in the center of a passive appliance to close the space symmetrically. Space closure can be achieved by using appliances according to embodiments described herein to change the angle of the teeth or by using stiffer springs for teeth requiring less relative movement. Similarly, softer springs may be used for teeth requiring more movement.

[0225] An exemplary process for closing an extraction space using an appliance according to embodiments described herein is shown and described with reference to FIGS. 22a and 22b. Referring to FIGS. 22a and 22b, an appliance 2200 (shown in a partial view) includes multiple caps 2201 according to a third embodiment. The appliance 2200 is shown in an untensioned or passive state, released from the teeth in FIG. 22a. The appliance 2200 is shown engaged and secured to the teeth in FIG. 22b. In FIG. 22b, the extraction space 2202 is shown in a position where, for example, a tooth (such as, but not limited to, a bicuspid) has been extracted. When the appliance 2200 is placed, the spring member (formed by the interdental loop 2204) becomes tensioned and applies a force to one or both adjacent teeth (e.g., on the upper second bicuspid 2206 and upper canine 2208), moving those teeth to close the extraction space 2202.

[0226] Another exemplary appliance according to the fourth embodiment is described and shown with respect to Figures 23a and 23b. In Figure 23a, an appliance 2300 (shown in a partial view) according to one example of certain embodiments described herein is in a passive state, such as before being placed in a patient's mouth. In Figure 23b, the appliance 2300 is connected to a tooth, for example, using a cap as described herein. In Figure 23b, an arm 2302 of the appliance 2300 is connected to a canine tooth and is extended compared to the arm 2302 shown in Figure 23a due to the extraction space and spring force on the arm 2302.

[0227] The methods described with reference to FIGS. 20 and 21 can be implemented in conjunction with a clinician (or other appropriate personnel) using a processing system as described. A processing system 2400 that can be used for such methods is shown generalized in FIG. 24 and includes a processor 2401, an input device 2402, a display device 2403, and an imaging or scanning device 2404 (or other appropriate device for imaging a patient's OTA). The processor 2401 may be connected to one or more fabrication systems 2406 (including fabrication machines) for fabricating the instrument (and its components and its tools) as described herein. The processor 2401 may be connected to the fabrication systems 2406 by any suitable communications connection 2408, including, but not limited to, a direct electronic connection, a network connection, etc. Alternatively, or in addition, the connection 2408 may be provided by the provision of a physical, non-transitory storage medium to the fabrication system 2406 on which data from the processor is stored. The non-transitory storage medium may include, but is not limited to, one or more of RSB connectable memory, memory chips, floppy disks, hard disks, compact disks, or any other suitable non-transitory data storage medium.

[0228] While various embodiments and examples described herein include or use male connector elements on the appliance that engage and secure female connector elements to the teeth, other embodiments and examples can be configured with female connector elements on the appliance and male connector elements on the teeth as well.

[0229] The embodiments disclosed herein are illustrative in all respects and should not be considered restrictive. The present disclosure is in no way limited to the above-described embodiments. Various modifications and changes can be made to the embodiments without departing from the spirit and scope of the present disclosure. Various modifications and changes that come within the meaning and range of equivalents of the claims are intended to be within the scope of the present disclosure.

Claims

1. 1. An appliance for attachment to a patient's teeth, comprising: Arch-shaped member a plurality of spring members coupled to or provided on the arched member; a plurality of anchoring members carried by said arch-shaped member for anchoring to a plurality of the patient's teeth; The arcuate member and the plurality of springs both have a length dimension and a width dimension with a width that varies along the length dimension, and the device comprises a two-dimensional structure bent into a three-dimensional structure.

2. 10. The appliance of claim 1, wherein each fixation member comprises: (a) a respective separate male connector element configured to engage with one or more respective separate female connector elements bonded to one or more of the patient's teeth; or (b) a respective separate cap configured to be snugly secured to one or more of the patient's teeth.

3. the arch-shaped member is configured to correspond to and extend along an arch of the patient's jaw when the appliance is placed on the patient's teeth; 10. The appliance of claim 1, wherein when the arched member extends along the jaw of the patient, each spring member is positioned along the arched member at a location between two teeth of the jaw of the patient.

4. 10. The appliance of claim 1, further comprising a plurality of arms extending from the arch-shaped member, each arm corresponding to one or more teeth of the patient, and each fixation member of the plurality of fixation members being attached to one of at least one different one of the arms relative to each other fixation member.

5. 5. The appliance of claim 4, wherein each fixation member comprises: (a) a respective separate male connector element configured to engage with one or more respective female connector elements bonded to one or more of the patient's teeth; or (b) a respective separate cap configured to be snugly fitted and secured to one or more of the patient's teeth.

6. 5. The device of claim 4, wherein each spring member of said plurality of spring members is disposed along a respective one of said arms that is different relative to each of the other spring members.

7. 7. The device of claim 6, wherein each spring member is provided on said respective one of said arms at a location between said arcuate member and said fixed member attached to said arm.

8. 8. The device of claim 7, wherein each locking member is separate from and does not cover any portion of the spring member of the arm to which it is attached.

9. 10. The appliance of claim 1, wherein each fixation member comprises a respective separate cap configured to fit snugly and be secured to one or more of the patient's teeth when the appliance is in place, the plurality of fixation members comprising a plurality of caps arranged along the arch-shaped member, each separate cap being separate from one or more other caps of the plurality of caps.

10. 10. The appliance of claim 1, wherein each fixation member comprises a T-shaped member configured to engage a slot in a female connector element bonded to one of the patient's teeth.

11. An appliance to be placed on a patient's teeth, Arch-shaped member a plurality of arms extending from the arch-shaped member, each of the arms corresponding to one or more different individual teeth of the patient's teeth relative to each other arm of the plurality of arms; a plurality of anchoring members for anchoring to a plurality of the patient's teeth, each anchoring member of the plurality of anchoring members attached to one or more of the arms.

12. 12. The apparatus of claim 11, wherein each fixation member of the plurality of fixation members is attached to a different respective one of the arms relative to each other fixation member of the plurality of fixation members.

13. 12. The appliance of claim 11, wherein each fixation member comprises: (a) a respective separate male connector element configured to engage with one or more respective female connector elements bonded to one or more of the patient's teeth; or (b) a respective separate cap configured to be snugly fitted and secured to one or more of the patient's teeth.

14. 12. The device of claim 11, further comprising a plurality of spring members coupled to or provided on one or more of said plurality of arms such that one or more of said arms includes at least one spring member.

15. 15. The device of claim 14, wherein each spring member is provided on a respective one of the arms at a position between the arched member and the fixed member attached to the arm.

16. 15. The device of claim 14, wherein each locking member is separate from and does not cover any portion of the spring member of the arm to which it is attached.

17. 12. The appliance of claim 11, wherein each fixation member comprises a respective separate cap configured to fit snugly and be secured to one or more of the patient's teeth when the appliance is in place, the plurality of fixation members comprising a plurality of caps arranged along an arch formed in the arch-shaped member, each separate cap being separate from one or more other caps of the plurality of caps.

18. 1. A method of making an appliance for placement on a patient's tooth, comprising: cutting a flat sheet of material into a two-dimensional shaped structure having length and width dimensions and a thickness corresponding to the thickness of said sheet of material; bending the two-dimensional structure into a three-dimensional structure having an arched member and a plurality of spring members coupled to or disposed on the arched member; and supporting a plurality of anchoring members on said arch member for anchoring to a plurality of said patient's teeth.

19. 20. The method of claim 18, wherein each fixation member comprises: (a) a respective separate male connector element configured to engage with one or more respective female connector elements bonded to one or more of the patient's teeth; or (b) a respective separate cap configured to be snugly fitted and secured to one or more of the patient's teeth.

20. the arch-shaped member is configured to correspond to and extend along an arch of the patient's jaw when the appliance is attached to the patient's teeth; 20. The method of claim 18, wherein each spring member is positioned along the arched member at a position between two teeth of the patient's jaw as the arched member extends along the patient's jaw.

21. 20. The method of claim 18, wherein cutting further comprises cutting the flat sheet material to form a plurality of arms extending from the arch-shaped member corresponding to one or more of the patient's teeth, and wherein supporting the plurality of fixation members comprises providing each fixation member of the plurality of fixation members on a different one or combination of the arms relative to each other fixation member.

22. 22. The method of claim 21, wherein each fixation member comprises: (a) a respective separate male connector element configured to engage with one or more respective female connector elements bonded to one or more of the patient's teeth; or (b) a respective separate cap configured to be snugly fitted and secured to one or more of the patient's teeth.

23. 22. The method of claim 21, wherein each spring member of the plurality of spring members is disposed along a different respective one of the arms relative to other spring members.

24. 22. The method of claim 21, wherein each spring member is provided on a respective one of the arms at a location between the arcuate member and the fixed member attached to the arm.

25. 25. The method of claim 24, wherein supporting a plurality of fixed members includes supporting each fixed member at a position spaced apart from the spring member of the arm to which it is attached and not interfering with any portion of the spring member.

26. 20. The method of claim 18, wherein supporting a plurality of fixation members includes providing separate caps configured to be fitted and secured to one or more of the patient's teeth when the appliance is placed, and supporting each cap such that the cap is positioned along the arch member and such that each separate cap is separate from one or more other caps of the plurality of caps.

27. 20. The method of claim 18, wherein supporting a plurality of fixation members comprises supporting a plurality of T-shaped members configured to engage a slot of a female connector element bonded to one of the patient's teeth.

28. obtaining a three-dimensional image or template of a desired arrangement of the patient's teeth; converting the three-dimensional image or template into a two-dimensional image or template; 20. The method of claim 18, wherein cutting the flat sheet material into a two-dimensional structure comprises cutting the flat sheet material into a shape corresponding to the two-dimensional image or template.

29. 20. The method of claim 18, wherein the flat sheet material comprises a sheet of nitinol.

30. 20. The method of claim 18, wherein the flat sheet of material comprises a sheet of shape memory metal.

31. 20. The method of claim 18, wherein at least one of a length dimension or a width dimension of the two-dimensional structure varies across the width or length of the two-dimensional structure.

Images