Patent ID: 12220294

DETAILED DESCRIPTION

Orthodontic appliances are used to correct malocclusion of the teeth. Orthodontic appliances generally can include brackets bonded to individual teeth and an archwire adjoining the brackets for exerting forces between the teeth to bring them into proper alignment. Non-sliding orthodontic appliances may employ an archwire and brackets that are configured to lock together such that the archwire is unable to slide relative to the brackets. Non-sliding orthodontic appliances can, in some cases, provide better control over the forces applied to correct the positioning of the patient's teeth. Archwires used in non-sliding orthodontic devices can include in some cases male fasteners for locking into brackets in a non-sliding engagement and interproximal structures, e.g., loops positioned between some and/or each and every male fastener for exerting precise corrective forces on adjacent brackets (FIG.3). Brackets can be applied to a patient's teeth using indirect bonding trays which hold a plurality of brackets in proper alignment relative to the patient's teeth

Disclosed herein are systems, methods, and devices for transferring and applying orthodontic brackets, or other suitable orthodontic appliances, to a patient's teeth using indirect bonding trays. Indirect bonding trays can be custom shaped to fit one or more of an individual patient's teeth. The indirect bonding trays may fit the entire upper or lower dental arch or a portion of the upper or lower dental arch. The indirect bonding tray may be formed from a physical model of the patient's teeth and includes one or more spaces or wells for accommodating the orthodontic brackets to be transferred to the patient's teeth. The physical model may be obtained from a digital representation of the patient's teeth, which can be digitally modified to model the precise placement of the orthodontic brackets on the patient's teeth. The basis of the digital representation can be acquired from a 3D intraoral scan of the patient's teeth, a physical model of the patient's teeth, and/or a negative impression of the patient's teeth. The indirect bonding tray may be formed from polyvinyl siloxane (PVS) or any other suitable elastomeric material, such as those used to form dental impressions. The indirect bonding tray may be entirely or partially molded to a patient's teeth.

The indirect bonding tray may generally comprise a buccal side, a lingual side, and an occlusal side for enclosing the one or more teeth. The indirect bonding tray may have a generally rounded or rectangular outer cross-section. The cross-section of the indirect bonding tray may be uniform along the length of the dental arch or may vary (e.g., change shape or dimensions). In some embodiments, the indirect bonding tray may comprise one or more handles, which can be integrated handles, in some embodiments.FIG.1Ashows an example of an indirect bonding tray100comprising two integral handles102. The handles102may be configured to facilitate insertion and/or placement of the indirect bonding tray100in a patient's mouth with the use of tool. The handles102can allow an orthodontist to insert the indirect bonding tray100into the mouth of the patient without use of his or her hands. The one or more handles102may extend (e.g., an increased height or other dimension) from the buccal, lingual, and/or occlusal side of the indirect bonding tray100. The handle102may be a flange, bridge forming a tunnel, or other appropriate shape. The handle102may extend along a longitudinal axis of the indirect bonding tray100defined by the curvature of the dental arch. The handle102may extend the entire length of the indirect bonding tray100or may extend only along one or more portions of the indirect bonding tray. For example, the handles102shown inFIG.1Aextend only along the distal right and left ends of the arch. The one or more handles102could be bilateral as shown, or unilateral in other embodiments (e.g., the handle102is only disposed on the right or left side of the arch), and render the device symmetric or asymmetric along one, two, or more axes.

The absence of the handle102along the anterior portion of the indirect bonding tray100may facilitate access to the distal portions of the tray once the tray is inserted into the patient's mouth. A practitioner's hand, fingers, or tools may more readily access the distal portion of the indirect bonding tray100and/or the patient's dental arch over the anterior medial portion of the indirect bonding tray100when the handle102is absent from that portion. The indirect bonding tray100may be formed with a variable cross section along the length corresponding to the dental arch. For example, as shown inFIG.1A, the medial anterior portion of the tray100may have a smaller cross-sectional area or general size than the surrounding distal portions. The smaller size of the anterior teeth may allow fabrication of the corresponding section of the indirect bonding tray100to be made smaller. The smaller size of the medial anterior portion may, for example, facilitate access to the distal portions of the mouth and tray100.

The handle102may comprise any suitable shape that facilitates grabbing the indirect bonding tray100with an instrument.FIGS.1Bi-1Bvii schematically illustrate various examples of possible configurations of the handle102. The handles102may be attached or integrally joined to the indirect bonding tray100along the bottom of the handle102.FIGS.1Bi-1Bvschematically illustrate cross-sections of the handles102taken along the longitudinal axis aligned with the dental arch. FIG.1Bvi schematically illustrates a lingual or facial side of a handle102. In some embodiments, the handle102may be a flange. The flange may have a rectangular shape, as shown inFIG.1A. The flange may have a T-shape (FIG.1Bi). In some embodiments, the handle102may be a flange having an L-shape (FIGS.1Bii and1Biii). In some embodiments, the handle102may have a U-shape to form a tunnel103that the orthodontist can use to grab onto with a tool. The tunnel103may be rounded (FIG.1Biv), squared, rectangular (FIG.1Bv), triangular (FIG.1Bvi), etc. In some embodiments, the tunnels103may be formed in a substantially lingual-to-facial direction rather than a mesial-to-distal direction. The handle102may have one or more apertures104disposed through it, extending, for example, from the lingual side to the facial/labial/buccal side of the handle102, as shown in FIG.1Bvii. The apertures104may allow the insertion of a tool or a portion of a tool, such as tweezers or graspers, through the aperture104to grasp the indirect bonding tray100. The apertures104may be round, square, rectangular, oval, oblong, or any other suitable shape. There may be 1, 2, 3, 4, 5, or more than 5 apertures104in each handle102. In some embodiments, the handle102may comprise both a tunnel103and one or more apertures104, the one or more apertures extending through the lingual side, the facial side, or both the lingual and facial side of the tunnel103. The handles102may be substantially rigid. The handles102may have a degree of flexibility to allow easy bending and manipulation by the insertion tool. In some embodiments, the handle102is integrally molded with the indirect bonding tray100from the same impression material as the tray100. In some embodiments, the handle100is a solid insert (e.g., plastic or metal) that may be integrated into the tray100as it is being molded or inserted into (e.g. pressed into) the tray100after the tray has been fabricated. In some embodiments, the handle102is attached to the tray100, such as with a biocompatible adhesive. In some embodiments, the handle102is removable from the tray100, such as with perforations or a frangible portion. In some embodiments, the handle102may include a magnet or ferromagnetic material to removably associate with a magnetic or metal portion of a tool.

FIG.1C, shows an example of an indirect bonding tray section101comprising an integral handle102. The handle102ofFIG.1Ccomprises an aperture104forming a bridge along the length of the handle for facilitating grasping by a tool105. In some embodiments, the indirect bonding tray100may be sectioned into one or more pieces or sections101(e.g., about or at least about two pieces, three pieces, four pieces, five pieces, etc.) prior to applying the tray100to the patient's mouth. In some embodiments, the indirect bonding tray100may be fabricated as one or more partial sections101corresponding to a patient's dental arch or a portion of a patient's dental arch. Each section101may have one or more handles102, only some of the sections101may have one or more handles102, or none of the sections101may have a handle102. The sections101may be inserted into a patient's mouth one after another. The smaller size of the sections101may facilitate insertion of the sections101into the patient's mouth and/or more accurate seating on the patient's teeth. Anatomical structures may be taken into account in determining where to section an indirect bonding tray100. For example, one tray could be used to place brackets on the left pre-molar and molar teeth, one on the cuspid and incisor teeth, and one on the right pre-molar and molar teeth. If upper and lower brackets are being applied, the sections101for the upper indirect bonding trays may be sectioned the same as or different from the section for the lower indirect bonding trays.FIG.1Ashows an indirect bonding tray which has been sectioned into three pieces.

The partial sections101may be configured to extend across distal or posterior teeth, across anterior or medial teeth, across the left teeth, across the right teeth, across the molar teeth, across the biscuspid teeth, across the bicuspid and cuspid teeth, across the incisors, across any adjacent combinations, or across any subset of teeth within those sections. In general, the sections101and/or the handles102on a tray100or section101may extend across one tooth, two teeth, three teeth, four teeth, five teeth, six teeth, seven teeth, eight teeth, nine teeth, ten teeth, eleven teeth, twelve teeth, thirteen teeth, fourteen teeth, fifteen teeth, or any portion of the dental arch (16 teeth) or a subset of adjacent teeth. Accordingly, trays100, corresponding to an entire dental arch or a portion of a dental arch, the third molar, may be sectioned generally between the third molar and the second molar, between the second molar and the first molar, between the first bicuspid and the second bicuspid, between the first bicuspid and the cuspid (canine tooth), between the cuspid and the lateral incisor, between the lateral incisor and the central incisor, or between left and right central incisors.

In some embodiments, pieces of an indirect bonding tray are formed by fabricating a unitary indirect bonding tray and sectioning (e.g., cutting) the unitary tray into several pieces. The unitary indirect bonding tray may be sectioned before or after insertion of the orthodontic brackets into the tray. Some portions of the unitary bonding tray may be sectioned off and discarded where no bracket is to be applied to the corresponding teeth. In some embodiments, portions of the indirect bonding tray corresponding to teeth without any brackets may be retained and used to facilitate seating of the indirect bonding tray in the patient's mouth. In some embodiments, sections of the indirect bonding tray may be fabricated separately rather than sectioned from a unitary tray. In some implementations, separately fabricated sections may be subsequently joined together prior to inserting the indirect bonding tray into the patient's mouth.

Indirect bonding trays may be labeled with one or more indicia or markers. Labeling indirect bonding trays may be especially advantageous for sectioned indirect bonding trays in order to facilitate proper registration between the various pieces of the tray and the teeth for which they are configured. Labeling may prevent confusion as to which piece is to be applied where and promote faster and more efficient transferring of brackets to the teeth. Labeling of the indirect bonding trays may be accomplished by any suitable means. In some embodiments, the tray may be impregnated with a colored dye during its fabrication to create a multi-colored tray. The color may correspond or register to a particular anatomical location per a color-code. This may be especially useful for distinguishing between upper and lower indirect bonding trays. The dye may be used to locally color regions of a single tray. The regions may correspond to pieces which are to be separately sectioned. In some embodiments, identifying information, such as tooth identifiers, may be printed on the surface of the indirect bonding tray. The information may be printed using for example a marker with non-toxic ink, stamped on the tray, or impressed into the tray.FIGS.1A and1Cdemonstrate the use of textual and graphic indicia106to visually provide treatment information to the practitioner. The indirect bonding tray100shown inFIG.1Aincludes identifying information on the surface of the tray, including tooth identifiers on one side, represented by numbers aligned approximately at the corresponding position of the identified tooth within the tray, bracket symbols indicating the medial and occlusal side of each tooth, an indication that the tray is for the lower mandible (“lower”) or the “lower right” portion of the mandible (“LR”), and suggested delineations demarcating where a tray could be sectioned. The delineations may be positioned approximately between teeth so that the tray is not sectioned through a portion corresponding to a tooth. The indirect bonding trays may also be labeled with adhesive labels. The adhesive labels can for example be printed out on a paper that has adhesive on one side. The paper may have a peel-away backing. The labels can be adhered to the surface of the indirect bonding tray. Other information that the trays can be labeled with include details of the orthodontic treatment, such as which teeth are to receive brackets, the total number of brackets, etc. Impressions of the patient's teeth may also facilitate proper registration of the indirect bonding tray. The tray may include impressions for teeth that are not to receive brackets in order to provide increased registration of the tray with the patient's dental arch. In some embodiments, the label could include a barcode, RFID tag, or another identification element.

After bonding one or more brackets or other orthodontic appliances to a patient's teeth, the placement of the brackets can be digitally checked for accuracy. A digital representation of the patient's teeth post-application can be created from a 3D intraoral scan or by other suitable means (e.g., a scan of a model or negative impression). The 3D scan of the patient's teeth can be imported into software that allows digital manipulation and/or analysis of the 3D scan. The digital model of the patient's teeth with applied brackets can be compared to an initial digital plan of the patient's teeth, including proposed placement of the brackets. For example, as illustrated inFIG.2A, the initial digital plan200for applying the brackets201(uncolored) and the clinical model202after applying (bonding) brackets203(shown in dark) can be digitally compared via a model204, such as by being superimposed, to allow visual evaluation of the discrepancies.FIG.2Billustrates an image of the superimposed model204ofFIG.2Aalone. In embodiments, where the comparison comprises a superimposition of the two models200,202, the two models may be additively combined to form a single volume having a continuous external surface (model204). The surface of each constituent model200,202may be visible only where it forms the external surface of the superimposed model204(is positioned relatively outside the surface of the other constituent model). The superimposed model204or image may be variably colored (or otherwise visually distinguished) across different portions of its external surface according to which constituent model200,202forms the external surface of the respective portion. In some implementations, in which the outer surfaces of the constituent models202,204are negligibly different when superimposed, the color of one of the two constituent models may be selected as a default or a third color may be used.

The software may compare the 3D geometry of the superimposed models204and determine areas of discrepancy. In some embodiments, the digital plan200and clinical model202are superimposed as different colors and the discrepancies are not highlighted, as seen inFIGS.2A and2B. The practitioner may evaluate the superimposed model204, for instance, by visually discerning whether the superimposed brackets201,203are aligned. For example, visual inspection may determine whether the corresponding brackets201,203from the two constituent models200,202substantially overlap forming the volume that would be expected from a single bracket or whether the two constituent brackets201,203are substantially displaced from one another. In some implementations, the software may visually highlight the areas of discrepancy to allow for easy evaluation by the orthodontist. The areas of discrepancy may be marked as the areas on a tooth's surface where the bracket was planned to be bonded but was not actually bonded and/or areas on a tooth's surface where the bracket was actually bonded but not planned to be bonded. These two types of discrepancies may be merged, such as marked by a single color, or distinguished (such as being marked by different colors). The software may highlight only the surface areas of the teeth or may highlight the 3D space where brackets were planned to occupy and/or were not planned to occupy. The software may compare the spaces occupied by the teeth and the brackets. The digital accuracy information, or any portion of the accuracy information, may be visually displayed on the superimposed model204or on either of the individual images (the digital plan200or the clinical model202). The orthodontist may use the accuracy information to evaluate the application of the orthodontic brackets and determine whether any corrections need to be made or whether any discrepancies or inaccuracies fall within a suitable range of error and/or are negligible. In some embodiments, the software may highlight areas of overlap rather than discrepancy. In some embodiments, the areas of overlap and discrepancy may be highlighted different colors. In some embodiments, the discrepancies are depicted on either the constituent planned model or the constituent clinical model. The discrepancies may be digitally limited to those in the bracket positions. The anatomical features may be assumed to be identical. Bracket positioning can be determined relative to anatomical landmarks.

The software may generate useful information regarding the accuracy of bracket placement. For example, in some implementations, the software may be programmed to perform an automated evaluation. The automated evaluation may report which brackets (i.e. teeth) were or were not accurately positioned. The software may use thresholds in displacement distances (e.g., distances between centers of brackets or maximum distances between corresponding points on edges of brackets from the two constituent models200,202), volumes (e.g., additive volume of brackets201,203), or surface areas (e.g., surface area of tooth covered by bracket on the superimposed model204) to qualify the bracket placements. The software may indicate (e.g. via a color or a box) on one or more of the models which brackets were within a level of tolerance and/or which brackets were outside the level of tolerance. The practitioner may be able to manually set the levels of tolerance and/or they may be set by the software. Statistics regarding the placement of the brackets may be accumulated for one or more patients. Statistical data reflecting the accuracy of bracket placement may be collected based on specific practitioners, teeth, types of brackets, bonding procedure, etc.

FIG.3illustrates an example of an orthodontic appliance301which uses non-sliding mechanics. The archwire303may comprise male loops or male fasteners304configured to be inserted into orthodontic brackets300in a configuration which prevents sliding of the archwire303relative to the orthodontic brackets300. The archwire303may comprise interproximal loops302, which may be positioned between one or more pairs of adjacent brackets300. The interproximal loops302may be configured to exert forces on the adjacent teeth to which the brackets300are bonded. The interproximal loops302may be configured to exert precision and/or customized forces on specific teeth. The forces from opposing sides of an orthodontic bracket300may be accounted for in providing a net force on each individual tooth.

Disclosed herein are systems and methods for calculating appropriate force application vectors configured to correct malocclusion of the patient's teeth. The system may include software for modeling the force vectors. The vectors may be determined by comparing a digital model of the pre-treatment geometry of the patient's teeth comprising initial tooth positions to a digitally corrected model of the patient's teeth comprising ideal tooth positions. A vector in three-dimensional (3D) space can be calculated for each individual tooth between its initial position (xi) and its final position (xf). Using the travel distance (length of the vector) along with information about the resistance of the teeth (e.g., the resistive force of tissue and the friction of tooth surface rubbing against one another), the tissue (e.g., the health of the gums), the jaw anatomy, and/or other patient factors (e.g., age, sex, etc.) a force vector can be determined for relocating the tooth from its initial position to its final position. The amount of force to be applied may be proportional to the resistance. The resistance of each tooth may be a scalar or may be a vector. The force may be calculated to achieve displacing the tooth across the travel distance over a predetermined treatment time (after which the archwire may be removed or replaced). Alternatively, using this information, the expected treatment time, or time it will take to relocate the tooth from its initial position to its final position, may also be estimated for a given applied force. In some embodiments, the determined treatment plan may comprise a single application of a relatively constant force. In some embodiments, the determined treatment plan may comprise sequential applications of various force vectors to appropriately reposition the tooth. The calculated force vector may be applied to the tooth using an archwire. The software may be able to determine the optimal number of treatments (e.g., archwire replacements). The software may account for the different force/treatment time ratios of teeth within the dental arch in determining appropriate forces to apply to each treated tooth such that the teeth are all moved into expected positions at the end of a definite treatment time. In some implementations, the applied force may not exceed a maximum level of force to ensure patient comfort and/or safety.

As shown inFIG.3, referenced elsewhere herein, the archwire can be bent between brackets to form interproximal loops302, which can be biased to expand outward or contract inward applying force against the brackets300on adjacent teeth. The interproximal loops302may be configured to rotate one or more teeth. The archwire303can be twisted around its axis to provide a torsional force on the adjacent bracket or brackets300. Brackets300that employ non-sliding mechanics, wherein the archwire303is fixedly secured to each bracket300and does not slide relative to the bracket300, may be ideal for using an archwire303to provide custom individualized forces to each tooth. The archwire303can comprise a shape memory alloy (e.g., nitinol). The shape-memory archwire303may be programmed with a pre-deformed shape that when applied to the ideal tooth positions does not cause the teeth to move. The shape memory archwire303may be deformed with interproximal loops302, each configured such that the transition from the deformed geometry when applied to the initial positioning of teeth to the pre-deformed geometry when applied to the final positioning of teeth supplies the appropriate pre-determined force vector to the adjacent teeth to move the teeth toward their planned final positions. The interproximal loops302and/or twisting of the archwire303may be configured to be in an unbiased configuration (e.g., a preprogrammed shape memory configuration) in the final position of the teeth and the initial archwire configuration may be configured to exert the calculated force. The precise shape or configuration of the archwire in the initial configuration may control the force vector asserted on the adjacent teeth. More complex treatment plans may be accomplished by changing archwires at different points throughout the treatment process to adjust the force vectors applied on one or more of the patient's teeth.

In some implementations, the actual displacement observed or measured after the application of orthodontic treatment, such as with an archwire comprising interproximal loops302, may be used to generate feedback, which may improve the modeling of a subsequent archwire and one or more force vectors. Tooth positioning may be obtained by 3D intraoral scans, impressions, or any other suitable method, including those discussed elsewhere herein.FIG.4schematically illustrates a 3D model showing the superimposed position of a single tooth before and after orthodontic treatment (i.e. tooth movement). The original position of the tooth is indicated in a 3D coordinate space (an XYZ coordinate grid) as X, Y, and Z (Ψ, θ, Φ). The position of the same tooth after treatment/movement is indicated by X′, Y′, and Z′. The displacement vector between the initial and final positions is indicated by ΔX, ΔY, and ΔZ. The actual displacement vector may be compared to the anticipated or planned displacement vector from which the force vector for the original treatment was calculated. Using this feedback, the algorithm for calculating force vectors configured to displace teeth may be updated to more accurately move the tooth or teeth in the next round of treatment. The difference between the planned displacement and the actual displacement may reflect patient-specific factors that affect how the tooth responds to force. These factors (age, sex, gum health, etc.) may be accounted for in variables such as the tooth resistance, for instance. For example, in a non-limiting embodiment, the resistance variable may be adjusted such that the planned model of the prior treatment more accurately approximates the actual movement observed. The interproximal loops302in successive archwires can be continually improved to optimize force delivery via the feedback loop. In some implementations, the system may become progressively smarter (more accurate) as more data is input for a specific patient. Increasing the number of archwire replacements may increase the accuracy of treatment. For instance, the archwire may be replaced 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 28, 29, 30, or more than 30 times during the orthodontic treatment. In some embodiments, the archwire may be replaced approximately once every month, 2 months, 3 months, 4 months, 5 months, 6 months, more than once a month, or less than every 6 months. In some embodiments, the archwire may be replaced more frequently during the initial period of orthodontic treatment so the model learns more effectively early on. In some embodiments, the archwire may be replaced at relatively frequent intervals throughout the entire orthodontic treatment. In some embodiments, the archwire may be replaced more frequently near the end of the orthodontic treatment to closely fine-tune the final positioning. The improved accuracy of treatment from the feedback model may ultimately decrease the time it takes to complete the entire orthodontic treatment, as the archwires will be less likely to overcorrect or under-correct teeth positions and additional corrections will be less needed.

Disclosed herein is an archwire for applying corrective force on a patient's teeth. The archwire may apply force through brackets bonded to the patient's teeth. The archwire may be coupled to each bracket through non-sliding mechanics such that the archwire is fixed relative to each bracket, such as archwire303. Force may be applied to move the teeth via interproximal loops302formed in the archwire adjacent to the brackets, as referenced elsewhere herein. The archwire may be generally curved to match the curvature of the patient's upper or lower dental arch. The archwire generally extends from a right end to a left end of the mouth. The left end of the archwire terminates either within or distal to the distal-most bracket positioned on the left side of the patient's mouth. The right end of the archwire terminates either within or distal to the distal-most bracket positioned on the right side of the patient's mouth. Often, the distal-most brackets will be positioned on a patient's molar teeth. A non-sliding orthodontic appliance is advantageous in that the archwire will not slide relative to the brackets, including the most distal brackets, and therefore will not slide distally relative to the distal-most brackets. In orthodontic appliances that employ sliding-mechanics, the archwire usually slides continually in a distal direction as the treatment progresses. Because the archwire of a non-sliding orthodontic appliance cannot slide distally relative to the distal-most brackets, the right and left ends will not inadvertently slide into and jab the patient's oral tissue causing discomfort or pain, even as treatment progresses.

FIGS.5A-5Bschematically illustrate examples of archwires500with modified distal ends. The right and left ends of the archwire may further be configured to form atraumatic terminal ends502so as to avoid causing pain or discomfort to the patient during any transient contact with oral tissue of the patient's mouth. Doing so may increase patient tolerance of the orthodontic appliance. In some embodiments, the right and left ends of the archwire500may be bent into terminal loops504to form atraumatic terminal ends502. FIG.5A schematically illustrates a distal end of the archwire500comprising a terminal loop504. The terminal loops504may be configured so that the ends of the archwire are bent back on themselves and point toward the most distal brackets, in an occlusal direction away from the patient's oral tissue, in a direction toward the tooth, or in some combination thereof. The terminal loop504may be configured to direct the right and left ends of the archwire500away from the adjacent lingual or buccal/labial tissue. Any direction which positions the end of the wire500away from oral tissue may be employed. The terminal ends of the archwire500may be formed by rounded bends in the distal terminal loops which are atraumatic.

In some embodiments, the terminal ends of the archwire500are capped with bulbs/bulbous ends506, enclosing any sharp edges of the archwire500. The bulbs506may be formed of a biocompatible material (e.g., non-toxic). The bulbs506may be stable so that they do not degrade over the course of the orthodontic treatment. The bulbs506may be formed of a polymeric material. The bulbs506may be formed of an adhesive, such as those used to bond brackets to teeth, which may be applied to the right and/or left ends of the archwire. In some embodiments, the bulbs506may be formed of a soft elastomeric material (e.g., PVS). The ends of the archwire500may be dip-coated with the biocompatible material. The biocompatible material may be injected or painted onto the left and right ends of the archwire500. In some embodiments, the biocompatible material may be hardened on the ends of the archwire500by curing (e.g., heat cured or light cured). Curing may be accomplished through standard dental instruments, such as dental curing lights. In some embodiments, the biocompatible material may hardened by air-drying. The hardened bulb506may be shaped during and/or after hardening to form a generally rounded, atraumatic terminal end. For instance, the bulb506may be shaped by standard dental tools (e.g., drills, graspers, polishers, etc.) after it has hardened to alter the shape and/or surface of the bulb506. In some embodiments, the bulb506may be prefabricated, for instance from a rubber silicone, and contain a channel for receiving an end of the archwire500. The right and left ends of the archwire500can be inserted into the channel and secured therein. The archwire500may be secured by a friction fit and may be removable from the bulb506through application of sufficient force. In some embodiments, the end of the archwire500may be secured within the channel via a biocompatible adhesive. The bulbous cap506may be heated after attaching to the distal end of the archwire500. Heating may shrink and/or bond the bulbous cap506to the archwire500. The right and/or left ends may be bent to form atraumatic terminal ends502in addition to capping the wire end with bulbs506.

In some embodiments, the right and left ends of the archwire500may be secured within the distal-most right and left brackets such that they do not protrude from the brackets. For example, the archwire500may contain a plurality of male fasteners where each male fastener secures the archwire to a bracket such that the archwire cannot slide laterally (in a mesial-distal direction) with respect to the bracket. The right and left terminal ends of the archwire500may be formed distally to the right and left most distal male fasteners within sufficient proximity to the male fasteners such that they do not extend out of bracket slots configured to receive the archwire. For instance, the archwire may terminate at one its distal ends at or near the point508indicated inFIG.3, with respect to a distal bracket. The interaction of the male fasteners with the brackets prevents the archwire from sliding medially with respect to the brackets such that the archwire500remains securely engaged with the brackets. In some implementations, an orthodontic appliance may be configured with brackets specially configured as the distal-most brackets. The distal-most brackets may be configured with archwire slots that are configured to redirect and/or retain the terminal ends of the archwire. The distal-most brackets may have archwire slots that only open to the medial side of the bracket. The archwire slot may form a closed channel which prevents the distal end of the archwire from protruding from the bracket. For instance, the bracket300depicted inFIG.3may have a distal sidewall510which extends (not shown) to occupy the space within the distal archwire slot of the bracket such that the archwire slot does not extend through to the distal side of the bracket. In some embodiments the distal-most brackets may comprise an archwire slot having a medial opening and an opening directed in another direction (e.g., in an occlusal direction) to direct the terminal end of the archwire away from distally positioned oral tissue. The archwire500may be bent during fabrication or during introduction into the patient's mouth in order to conform to the modified slot of the distal-most brackets. The embodiments disclosed herein may be combined, such that the right end and left end of an archwire may be made atraumatic through the same or different means.

Disclosed herein are systems, devices, and methods for registering non-sliding archwires with orthodontic brackets. Orthodontic appliances that employ non-sliding mechanics may include an archwire with interproximal loops and/or male fasteners, as referenced elsewhere herein. Each interproximal loop may be positioned between two male fasteners. The interproximal loop may be configured to exert precise forces on two adjacent brackets to correct the positioning of the teeth to which the brackets are bonded. The surrounding male fasteners may be used to secure the archwire to those adjacent brackets in a non-sliding manner. Because the archwire may comprise a plurality of interproximal loops that are specifically configured with correction forces for different sets of teeth and because the archwire locks into a plurality of brackets in a non-sliding manner, the registration of the archwire with the brackets bonded to specific teeth is not trivial, especially compared to orthodontic appliances that rely on sliding mechanics. If the archwire is not properly registered to the respective orthodontic brackets (is misregistered), the proper orthodontic treatment may not be delivered. A system that allows quick and efficient registration may also save time and effort relative to correcting a misregistered orthodontic appliance during delivery to the patient.

In some embodiments, the archwire is registered to the brackets using a color registration system. The color registration system may include placing distinct color markings on the archwire and brackets to which the archwire is to be locked into. The archwire may be marked at or near a male fastener element or other locking element that corresponds to a given bracket. The color may match that of a marking on the corresponding bracket. In some embodiments, each fastener/bracket combination is assigned a distinct color (e.g., red, blue, green, yellow, orange, black, etc.). In some embodiments, the same color may be reused. For instance, adjacent brackets/fasteners may be marked with alternating colors or left and right sides of the mouth may use the same colors for corresponding left and right teeth. In some implementations, an orthodontic appliance is applied to the upper mandible and to the lower mandible. The upper and lower appliances may use distinct colors from each other or the same registration patterns. In some embodiments, color markings may be used not to register the archwire with particular brackets in an orthodontic appliance but to distinguish the upper and lower orthodontic appliances from each other or a color system may be used which performs both.

The color markings may be applied to the archwire and brackets according to any suitable method. The archwire and brackets may be painted with non-toxic dyes that are suitable for coloring metal materials. The archwire and brackets may be subject to chemical reactions, heating, anodization, or other physical reactions that can change the color of the metal without significantly altering the material properties of the archwire or bracket. The coloring of the orthodontic appliances may be relatively permanent or temporary. For instance, the coloring may wash away over time, especially under the presence of water (e.g., saliva). The archwire and brackets may be colored by attaching a colored marking element to the devices. For instance, a colored plastic tube may be configured to attach to the archwire. The tube may have a diameter substantially the same as that of the archwire. The tube may comprise a slit along its circumference that allows the tube to be slipped over the archwire and frictionally retained thereon. The tube may be easily removable from the archwire and can be removed after the orthodontic appliance has been properly registered. Other suitable configurations of color marking elements may be attached as well. Colored ribbons, strings, films, elastic bands, beads, etc. may be attached to the archwire and/or brackets. The color marking elements may be removed upon registration or may be left in place. The brackets may be marked with colored inserts that are configured to be received within (e.g., snap into) a portion of the geometry of the bracket. The inserts may insert into a portion of the bracket's archwire slot or a channel for receiving the male fastener/locking member and be removed just prior to the insertion of the archwire into each bracket. In some embodiments, the insert may be inserted into a residual or non-functional space within the bracket that is visible to the orthodontist and may need not be removed prior to insertion of the archwire. The insert or other color indicator on the bracket may be positioned such that is visible to the practitioner when working in the patient's mouth but not be readily visible to others in daily life. For instance, the color indicator may be relatively small, occluded by the patient's gums, positioned on a distal/mesial side of the bracket, and/or the brackets may be applied to lingual surfaces of the teeth. In such scenarios, it may be more amenable to leave the color indicator in place. The brackets may be designed with custom voids or spaces for receiving a colored insert. For example, the brackets may be fabricated with a bore configured to receive a custom colored peg. The peg may be configured to be inserted into the bore such that it forms a relatively smooth surface with the bracket when fully inserted. The inserts may be permanent or removable. In some embodiments, the inserts are inserted into the bracket after each bracket has been designated to a particular tooth. The inserts or other color indicator may, for example, be inserted after the brackets have been placed in an indirect bonding tray. In some implementations, the insert or other color indicator may be coupled to the brackets after the brackets are bonded to the teeth.

In some embodiments, a colored string, ribbon, or elastic band may be placed around the bracket or a portion of the bracket. The string, ribbon, or elastic band may be removed just prior to registering the archwire in each bracket. The string, ribbon, or elastic band may be cut after registering the archwire with the bracket. In some implementations, the string, ribbon, or elastic band may occupy the space of a tie configured to facilitate securing the archwire to the bracket and may be removed prior to placing the tie. The present disclosure encompasses combinations of the colored marking systems disclosed herein. In some embodiments, each bracket and corresponding fastener (or identifying portion of the archwire) will be color-coded. In some embodiments, only select brackets and corresponding fasteners will be color-coded. Registration of only a portion of the brackets with the archwire may be sufficient to improve the efficiency of registering the archwire with the brackets.

Disclosed herein are system, methods, and devices for fixing an archwire to a plurality of orthodontic brackets to form an orthodontic appliance that employs non-sliding mechanics between the archwire and the brackets. In some embodiments, the bracket and the archwire may be configured to be locked together using a crimpable stop. The archwire may comprise a stop member for engaging with a channel or slot of the bracket. The stop member may be a projection extending laterally from the archwire. The stop may be formed from one or more bends in the archwire to form a male fastener with a loop, such as a U-shaped loop, V-shaped loop, teardrop-shaped loop, etc., or may be formed as an integrated piece of material extending from the archwire. For example, the stop may be a post extending away from the archwire, a thin sheet extending from the archwire, a tube around the axis of the archwire, or a deformable portion of the archwire. The orthodontic bracket may comprise structures configured to engage the stop and fix it in place relative to the bracket, such that it cannot slide. For example, the orthodontic bracket may include a flange, one or more projections, a tube or partial tube, or other locking element which can physically engage the stop. The stop, locking element, or both may be plastically deformable such that the stop and locking element may be crimped together to secure the archwire to the bracket. The plastically deformable portions of the stop and/or locking element may comprise metal that is softer and more malleable than the remainder of the archwire/bracket and/or may be fabricated in sufficiently small dimensions (e.g., thin cross-sections) such that they are readily plastically deformable under the application of sufficient force. The archwire and bracket may be locked together in a non-sliding configuration by inserting the archwire into the slot such that the stop engages the locking member and by applying a physical force to crimp the stop to the locking member. The physical force may be applied via a standard orthodontic tool, such as orthodontic pliers. In some embodiments, more than one crimpable stop may be used to lock the archwire in place with a single bracket. In some embodiments, the stops can be used or modified for use with lower anterior brackets, such as those disclosed in U.S. patent application Ser. No. 15/490,278 to Tong et al., which is hereby incorporated by reference in its entirety.

For example, the crimpable stop may be a male fastener wherein the loop is crimped around a projection of the bracket, such as central projection306inFIG.3. In another example, the archwire is inserted into a partial tube which is then crimped around the archwire or a flange from the bracket is bent around the archwire and crimped to secure the archwire in place. In another example, a post extending from the archwire may be inserted into a tube or partial tube which may be crimped around the post. In yet another example, the archwire comprises a thin flat sheet which may be deformed around a projection extending from the bracket. In some embodiments, the cross-section of the archwire may be plastically deformed where it is locked into place by the bracket, which may prevent the archwire from sliding relative to the bracket and/or from being readily removed from the bracket. In some embodiments, the crimping of the archwire to the bracket may form an orthodontic appliance which lacks some or all torque control around the axis of the archwire.

In some embodiments, the crimpable stop is a tube that is placed around the archwire. The tube may be slid over a distal end of the archwire. In some embodiments, the tube may have a slit along the length of the tube or the tube may only comprise a partial circumference, which may allow the tube to be placed around the archwire without sliding it on from the distal end. Unlike conventional orthodontic stops, the tube may be adapted to the non-sliding archwire and/or may be configured to lock into the bracket configured to receive the non-sliding archwire. For instance, the tube may be non-linear. The tube may be configured along its length or along portions of its length to resemble the shape of the interproximal loop, the male fastener, and/or the archwire slot. The tube may be configured to be received or partially received in the archwire slot. The tube may be crimped before or after the archwire is placed and/or locked into the orthodontic bracket.

FIG.6Aillustrates an example of a crimpable stop600. The crimpable stop600may be a cylindrical tube as described elsewhere herein. In some embodiments, the crimpable stop600may comprise a closed circumference and may be advanced over a distal end of an archwire602. In some embodiments, the crimpable stop600may be partially closed (e.g., may comprise a slit along the length of the stop) and may be advanced (e.g., slid) over a distal end or placed directly on the archwire602(i.e. the archwire602may be inserted into the crimpable stop600through the slit). In some embodiments, the crimpable stop may be tubular but may comprise a non-cylindrical shape. For instance, the crimpable stop600may have a square, rectangular, triangular, or other polygonal shape, or the crimpable stop may have an oblong cross-section. The crimpable stop600may serve as or replace a male fastener element described elsewhere herein for fixing the archwire602to an orthodontic bracket604in a non-sliding manner. The archwire602may be substantially straight or linear along the portion configured to mate with the orthodontic bracket (e.g., between interproximal loops). The archwire slot of the bracket604may be substantially linear, extending in a mesial-distal direction. The bracket604may comprise a recess606configured to at least partially receive the crimpable stop600and to prevent or at least partially inhibit the crimpable stop600from sliding in a mesial-distal when received in the recess606. The recess606may have a length configured to match or to be slightly larger than the length of the crimpable stop600as shown inFIG.6. The recess606may be formed by sidewalls of the bracket604. The recess606may be formed as part of the archwire slot. The recess606may have a depth extended beyond that of the archwire slot configured to at least partially receive the crimpable stop606.

In some embodiments, the crimpable stop600may be applied to the archwire602prior to insertion of the archwire602into the orthodontic bracket604. The crimpable stop may be crimped, as described elsewhere herein, after it is received within the recess606. The recess606may be sized or otherwise configured to allow at least partial insertion of a crimping tool (e.g., pliers, crimpers, graspers, etc.). Crimping the crimpable stop600to the archwire602may fixedly secure the stop600and archwire602together such that the archwire cannot be axially advanced (e.g., slid) through the crimpable stop600, even under force from interproximal loops. In some embodiments, the crimpable stop600may be applied to the archwire602after the archwire602is inserted into the orthodontic bracket604. In some embodiments, the crimpable stop600may be applied and crimped before the archwire602is inserted into the orthodontic bracket604. If multiple crimpable stops600are used, the application and crimping sequence may be the same or different for each stop600. The crimpable nature of the stop600may allow last minute fine-tuning of the fixed position of the archwire within the bracket604. This embodiment of crimpable stop may be particularly suitable for archwires in which torqueing forces are not needed or not desired to be exerted onto the teeth. In some embodiments, the crimpable stops may be colored. The crimpable stops may serve as the color-coded registration indicators described elsewhere herein for registering the archwire602(e.g., adjacent interproximal loops) with the proper orthodontic bracket605. In some embodiments, the stop may not be crimpable but may be fixed to the archwire602in another way, such as molding, such that the stop appears similar to wire insulation.

FIG.6Billustrates an embodiment of an archwire602comprising interproximal loops603and several tubular crimpable stops600(indicated by enclosing circles) positioned between some of the interproximal loops to fixedly secure the archwire602to brackets on the lower anterior teeth.

Various other modifications, adaptations, and alternative designs are of course possible in light of the above teachings. For example, features disclosed in U.S. Pub. No. 2014/0120491 A1 to Khoshnevis et al. can be utilized or modified or use with embodiments as disclosed herein. Therefore, it should be understood at this time that within the scope of the appended claims the invention may be practiced otherwise than as specifically described herein. It is contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the inventions. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an embodiment can be used in all other embodiments set forth herein. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed inventions. Thus, it is intended that the scope of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above. Moreover, while the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “tying a tie onto an orthodontic bracket” includes “instructing the tying of a tie onto an orthodontic bracket.” The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers (e.g., about 10%=10%), and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.