Aligner demolding device and automation method

Abstract

The present disclosure discusses devices and methods for securing dental models (100) to a thermoform plate (200) prior to thermoforming a polymer onto the dental model. The present disclosure also includes a system and method for separating a thermoformed polymer from a thermoform plate and dental model. Additionally, the present disclosure discusses a system capable of automating the process of forming an orthodontic aligner.

Description

International Patent Application OR4141PWO ALIGNER DEMOLDING DEVICE AND AUTOMATION METHOD Cross-Reference to Related Applications

[0001] This application claims priority to and benefit of U.S. provisional application number 63 / 548,670, filed February 1, 2024, and entitled “Aligner Demolding Device and Automation Method”; the content of which is incorporated herein by reference in its entirety. Field of the Technology

[0002] The present technology relates to dental appliance manufacturing techniques. More specifically, this technology relates to techniques for removing aligners from models. Background

[0003] Orthodontic aligners are appliances intended to make a series of discrete tooth position corrections aimed at aligning the teeth correctly. Aligners are equivalent to having bracket / wire braces for orthodontic treatment, but they have many advantages. For example, aligners are often transparent or semi-transparent, comfortable, and removable for cleaning and they allow a patient to eat anything they want.

[0004] The manufacture of aligners traditionally begins with generating a digital model of the patient’s dental arch, either by scanning the patient’s teeth, or by making a dental impression of the patient’s teeth and then scanning the impression. When an intra-oral scanning device (IOS device) is used to scan a patient’s teeth, three-dimensional computer aided design (CAD) representations can be imported by custom software. Alternatively, a mold of the patient’s teeth can be constructed from an impression and scanned with a tabletop scanner. The custom software allows the operator to move individual teeth in specific and discrete movements to achieve the final dental arch of aligned teeth.

[0005] Once a digital model of the patient’s dental arch has been acquired, physical dental models can be fabricated (e.g., using 3D printing techniques) to provide a positive model of the teeth. The model is washed and then allowed to dry. Once dried, a polymer is thermoformed over the top of the 3D printed arch model. 1 WBD (US) 59555578v1

[0006] The thermoformed part is then laser marked with part identification. The laser marked, thermoformed part is then cut by one of several methods so that the aligner that goes to the customer can be separated from the excess aligner material.

[0007] The aligner is then polished in a part tumbling process to remove burrs and sharp edges. The aligners are inspected and then sealed in bags to be shipped to the customer's orthodontist, or directly to the patient.

[0008] Generally, aligners are manually removed from the model and often manually trimmed as well. If the trimming is done automatically, the aligner is typically trimmed while it is still thermoformed to the model. One system of automatic trimming uses a drill-type trimming system. Drill-type trimming systems use a drill bit to create a cut in the thermoformed aligner to separate the aligner from the model. Drill bit drills, however, can cut into the 3D printed model causing debris and damaging the model. If a laser is used to cut the aligner, this can melt some of the underlying model material and cause some unwanted blending with the aligner material, along with the potential to generate toxic fumes and dust. Summary

[0009] The present technology solves the above problems by separating an orthodontic aligner from a dental model before trimming. With the aligner separated from the model, laser cutting can be performed without worrying about melting the underlying model and that melted material blending with the aligner. Since the underlying model is not damaged, the model can be reused to make additional aligners (i.e., additional copies) as needed.

[0010] The technology uses a locking system to secure the dental model to a thermoform plate. After an orthodontic aligner precursor is formed on the dental model, the thermoform plate is placed in a separation system. The separation system uses an applied vacuum or a partial reduced pressure to hold the aligner in place while it is separated from the dental model. The locking system provides sufficient force to the dental model to prevent the dental model from being pulled away from the thermoform plate when the orthodontic aligner precursor is removed from the dental model in the separation system. The separated orthodontic aligner precursor can be transferred to a cutting system where the excess thermoformed polymer can be removed from the aligner. The process can be automated through the use of a conveyance system.2 WBD (US) 59555578v1

[0011] Advantages of the present technology include the robustness to make thousands of clear aligners per day while reducing problems associated with cutting the aligners.

[0012] In one aspect of the present technology, a system for thermoforming an orthodontic aligner includes: a loading system, a thermoforming system, a separation system, and a conveyance system. The loading system is configured to automatically assemble a molding device. A molding device includes a thermoform plate for receiving and securing individually unique dental models and a dental model. The thermoform plate includes: a locating feature extending from a top surface of the thermoform plate and a locking system. The dental model is positioned on the thermoform plate. The dental model is a positive model of a dental arch. The dental model includes a locating socket having a shape complementary to the locating feature. The dental model is positioned on the thermoforming plate such that the locating socket mates with the locating feature when assembled. The locking system secures the dental model to the thermoform plate during use.

[0013] The thermoforming system is configured to form a polymer sheet over the molding device to form an orthodontic aligner precursor, on the dental model. The orthodontic aligner precursor includes the orthodontic aligner and excess thermoformed polymer at least partially surrounding the orthodontic aligner.

[0014] The separation system is configured to automatically remove an orthodontic aligner precursor from the dental model.

[0015] At least one conveyance system is configured to transport the molding device from the loading system to the thermoforming system and / or from the thermoforming system to the separation system.

[0016] The locking system provides sufficient force to the dental model to prevent the dental model from being pulled away from the thermoform plate when the orthodontic aligner precursor is removed from the dental model in the separation system. In one aspect of the present disclosure, the locking system includes a holding element coupled to the top surface of the thermoform plate. The holding element comprises an elongated bar that is coupled to the thermoform plate and contacts a portion of the locating socket and / or the locating feature.

[0017] In another aspect of the present disclosure, the locking system includes a holding element that is partially disposed in a body of the thermoforming plate. The holding element3 WBD (US) 59555578v1can be rotated from a first position, within the body of the thermoforming plate, to a second position in which a portion of the holding element contacts a portion of the locating socket and / or the locating feature.

[0018] The separation system includes a separation plate and a clamping system. The clamping system includes a clamp platform and a clamp ring. The dental model is attached to the separation plate, and a portion of the excess thermoformed polymer is fixed in place between the clamp platform and the clamp ring. The separation plate is movable away from the clamp platform to separate the orthodontic aligner precursor from the dental model. The separation plate is movable in a linear direction away from the clamp platform and / or can tilt with respect to the clamp platform.

[0019] In another aspect of the present disclosure, the separation system includes a clamping system. The clamping system comprises a clamp ring having a sealed separation chamber. When the thermoform plate, with the dental model and orthodontic aligner precursor attached, is positioned on the separation system, the clamp ring contacts a portion of the excess thermoformed polymer such that the excess thermoformed polymer is fixed in place between the clamp ring and the thermoform plate.

[0020] In one aspect of the present disclosure, the excess thermoformed polymer is fixed in place to the clamp ring by application of a vacuum to the orthodontic aligner precursor within the sealed separation chamber.

[0021] The system also includes a cutting system configured to produce the orthodontic aligner from the orthodontic aligner precursor by cutting off the excess thermoformed polymer. In one aspect of the present disclosure, the cutting system comprises a laser cutting device.

[0022] In one aspect of the present disclosure, the cutting system comprises a support plate having a locating feature extending from a top surface of the thermoform plate. The orthodontic aligner precursor includes a locating socket having a shape complementary to the locating feature. The orthodontic precursor is positioned on the cutting system support plate such that the locating socket mates with the locating feature on the support plate prior to cutting. The locating socket of the orthodontic aligner precursor is formed from the polymer sheet that contacts the locating feature of the dental model.4 WBD (US) 59555578v1

[0023] In an aspect of the present disclosure, a method for thermoforming an orthodontic aligner, the method comprising: obtaining a molding device; thermoforming a polymer sheet over the molding device to form an orthodontic aligner precursor; moving the orthodontic aligner precursor to a separation system; and separating the orthodontic aligner precursor from the dental model.

[0024] In one aspect of the present disclosure, a molding device includes: a thermoform plate for receiving and securing individually unique dental models and a dental model. The thermoform plate includes: a locating feature extending from a top surface of the thermoform plate; and a locking system that secures the dental model to the locating feature during use. The dental model is positioned on the thermoform plate. The dental model is a positive model of a dental arch. The dental model includes a locating socket having a shape complementary to the locating feature. During assembly of the molding device, the dental model is positioned on the thermoforming plate such that the locating socket mates with the locating feature.

[0025] The method includes thermoforming a polymer sheet over the molding device to form an orthodontic aligner precursor, on the dental model. The orthodontic aligner precursor includes the orthodontic aligner and excess thermoformed polymer at least partially surrounding the orthodontic aligner.

[0026] The method includes moving the orthodontic aligner precursor to a separation system. The separation system includes a clamping system. The method includes clamping the orthodontic aligner precursor within the clamping system and separating the orthodontic aligner precursor from the dental model by moving the dental model away from the clamping system.

[0027] The locking system provides sufficient force to the dental model to prevent the dental model from being pulled away from the thermoform plate when the orthodontic aligner precursor is removed from the dental model in the separation system. In one aspect of the present disclosure, the locking system comprises a holding element coupled to the top surface of the thermoform plate. The holding element comprises an elongated bar that is coupled to the thermoform plate and contacts a portion of the locating socket and / or the locating feature. In another aspect of the present disclosure, the locking system comprises a holding element that is partially disposed in a body of the thermoforming plate. The holding element can be rotated from a first position, within the body of the thermoforming plate, to a5 WBD (US) 59555578v1second position in which a portion of the holding element contacts a portion of the locating socket and / or the locating feature.

[0028] In one aspect of the present disclosure, moving the orthodontic aligner precursor to a separation system includes: removing the dental model with the attached orthodontic aligner precursor from the thermoform plate; and transferring the dental model with the attached orthodontic aligner precursor to the separation system.

[0029] The separation system, in one aspect of the present disclosure, includes a separation plate and a clamping system. The clamping system includes a clamp platform and a clamp ring. The method includes attaching the dental model to the separation plate and clamping a portion of the excess thermoformed polymer between the clamp platform and the clamp ring. The orthodontic aligner precursor can be separated from the dental model by moving the separation plate away from the clamp platform to separate the orthodontic aligner precursor from the dental model.

[0030] In another aspect of the present disclosure, the orthodontic aligner precursor is moved to a separation system by moving the thermoform plate, with the dental model and orthodontic aligner precursor attached to the separation system. The separation system includes a separation plate and a clamping system. The clamping system includes a clamp ring having a sealed separation chamber. In this aspect, the method includes positioning the thermoform plate, with the dental model and orthodontic aligner precursor attached, in the separation system such that the clamp ring contacts a portion of the excess thermoformed polymer. A vacuum is created within the sealed separation chamber. The excess thermoformed polymer is fixed in place to the clamp ring by the application of the vacuum. The orthodontic aligner precursor can be separated from the dental model by moving the thermoform plate away from the clamp platform.

[0031] The method further includes cutting off the excess thermoformed polymer using a cutting system to produce the orthodontic aligner from the orthodontic aligner precursor. The cutting system, in one aspect of the present disclosure, includes a laser cutting device.

[0032] In one aspect of the present disclosure, the cutting system includes a support plate having a locating feature extending from a top surface of the support plate. The orthodontic aligner precursor includes a locating socket having a shape complementary to the locating feature. The orthodontic precursor is positioned on the support plate such that the locating6 WBD (US) 59555578v1socket mates with the locating feature on the support plate prior to cutting. The locating socket is formed from the polymer sheet that contacts the locating feature of the dental model.

[0033] In one aspect of the present disclosure, the method can be automated. In this aspect, obtaining the molding device includes assembling the molding device at a molding system. Thermoforming the polymer sheet over the molding device is performed at a thermoforming system. Separating the orthodontic aligner precursor from the dental model is performed at a separation system. One or more conveyance systems can be used to automatically transport the molding device from the loading system to the thermoforming system and / or from the thermoforming system to the separation system.

[0034] In another aspect of the present disclosure, a thermoform plate for receiving and securing dental models includes: a locating feature extending from a top surface of the thermoform plate; and a locking system that secures the dental model to the thermoform plate during use.

[0035] In one aspect of the present disclosure, the locking system provides sufficient force to the dental model to prevent the dental model from being pulled away from the thermoform plate when an orthodontic aligner precursor is removed from the dental model during use.

[0036] In one aspect of the present disclosure, the locking system includes a holding element coupled to the top surface of the thermoform plate. The holding element includes an elongated bar that is coupled to the thermoform plate and contacts a portion of the locating socket and / or the locating feature.

[0037] In another aspect of the present disclosure, the locking system includes a holding element. The holding element is partially disposed in a body of the thermoforming plate. The holding element can be rotated from a first position, within the body of the thermoforming plate, to a second position in which a portion of the holding element contacts a portion of the locating socket and / or the locating feature.

[0038] In an aspect of the present disclosure, a molding device for forming an orthodontic aligner includes a thermoform plate for receiving and securing individually unique dental models. The thermoform plate includes a locating feature extending from a top surface of the thermoform plate; and a locking system that secures the dental model to the thermoform plate7 WBD (US) 59555578v1during use. A dental model is positioned on the thermoform plate. The dental model is a positive model of a dental arch. The dental model includes a locating socket having a shape complementary to the locating feature.

[0039] The dental model is positioned on the thermoforming plate such that the locating socket mates with the locating feature. The holding element covers at least a portion of the locator tab and the locating feature to hold the dental model against the thermoforming plate during use. Brief Description of the Drawings

[0040] The technology will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0041] FIG.1 shows a perspective view of a dental model.

[0042] FIG.2A depicts a cross-sectional view of a dental model coupled to a thermoform plate.

[0043] FIG.2B shows a perspective view of a dental model coupled to a thermoform plate.

[0044] FIG.2C shows a cross-sectional view of a thermoform plate with an alternate embodiment of a holding element.

[0045] FIG.3 shows a perspective view of a thermoformed polymer encapsulating the dental model, the locating socket, the locating feature, and the holding element.

[0046] FIG.4A and FIG.4B show a schematic side view of a separation system having a separation platform and a clamping system.

[0047] FIG.5A and FIG.5B show a schematic side view of a separation system having a tiltable separation platform and a clamping system.

[0048] FIG.6 shows a schematic side view of a separation system having an open ring clamping system.

[0049] FIG.7 shows a schematic side view of a separation system that uses a thermoform plate in combination with a clamping system.

[0050] FIG.8 shows a perspective view of a thermoformed polymer after separation from a dental model / thermoform plate.

[0051] FIG.9 shows a schematic view of a first processing method and system.

[0052] FIG.10 shows a schematic view of a second processing method and system.8 WBD (US) 59555578v1Detailed Description

[0053] The present technology includes a thermoform plate for receiving and securing individually unique dental models having a locating feature extending from a top surface of the thermoform plate. The thermoform plate further includes a locking system that secures the dental model to the thermoform plate during use. After an orthodontic aligner precursor is formed on the dental model, the orthodontic aligner precursor is removed from the dental model while the dental model is secured to the thermoform plate. During removal of the orthodontic aligner precursor, the locking system provides sufficient force to the dental model to prevent the dental model from being pulled away from the thermoform plate.

[0054] The thermoform plate can be used to form a molding device for forming an orthodontic aligner using a dental model. FIG.1 depicts an exemplary dental model 100. The dental model is a positive model of a dental arch. The dental model includes a locating socket 120 having a shape complementary to the locating feature on the thermoform plate.

[0055] During the thermoforming process, a dental model is positioned on the thermoform plate, as depicted, for example, in FIGS.2A and 2B. The dental model 100 is positioned on the thermoform plate 200 such that the locating socket 120 mates with the locating feature 220 of the thermoform plate 200. The dental model is further held onto the thermoform plate by use of a locking system. In one aspect of the present technology, the locking system includes a holding element 300 coupled to the top surface of the thermoform plate. During use, the holding element 300 is positioned such that the holding element covers at least a portion of the locating socket and the locating feature to hold the dental model against the thermoform plate. The holding element can be any device that can act as a clamp to hold the dental model against the thermoform plate.

[0056] In one aspect of the present technology, the holding element 300 includes an elongated bar 310 which is coupled to the thermoform plate 200. The holding element 300 includes a holding element base 315 which is connected to the upper surface of the thermoform plate and further connected to the elongated bar 310. As shown in FIGS 2A and 2B, the elongated bar 310 extends from a portion of the holding element base 315 over the locating socket 120. The elongated bar includes a cutout 320 which provides space for the locating socket and locating feature. As shown in FIGS.2A and 2B, the elongated bar extends over the locating socket and locating feature. To secure the dental model to the thermoform plate. The elongated bar is fixed to the holding element base and the thermoform9 WBD (US) 59555578v1plate using a fastener. In this example the fastener is a screw that is secured in a threaded opening 215 of the thermoform plate. However, it should be understood that other types of securement systems can be used in a similar manner, such as spring-loaded clamps, c-clamps, or vice clamps.

[0057] An alternate embodiment of a holding element is depicted in FIG.2C. In this embodiment, the holding element 350 can be rotated from a secured position (on the left) to an unsecured position (to the right). When rotated into the secured position is positioned such that the holding element 350 covers at least a portion of the locating socket and the locating feature (collectively 355) to hold the dental model 100 against the thermoform plate 200. The holding element 350 is embedded in the thermoform plate while in the unsecure position. Alternatively, the holding element may be part of a support that the thermoform plate is placed onto during thermoforming. In this alternate embodiment, the holding element may pass through the thermoform plate to move from the secured to unsecured positions. A knob 360 can be coupled to the holding element to allow the element to be easily moved from the secure to unsecure positions.

[0058] In one embodiment, the locating feature is a polygon cutout. However, the locating feature can include any other feature used to align or secure the dental model. In some embodiments, the locating feature of the dental model can mate with or interact with the holding element.

[0059] The locating socket area defines a cutout portion that can also include raised or cutout lettering. The lettering on the model locating socket can include a product identifier, a case identifier, a batch identifier, or another type of code that is used in downstream processing and manufacturing steps during the aligner production process. The lettering is used to identify and match to a specific 3D model. For example, a computer having a detector (e.g., using an optical character recognition camera) can scan the locating socket, read the lettering, and match a dental model based on the lettering instructions, which further streamlines the thermoform process.

[0060] In an example, the alphanumerical lettering represents a case number and / or a step / arch identifier, which may be in the form of an encrypted code. In some embodiments, rather than being raised lettering, the lettering may be cut through the entire model to allow for more accurate reading from an optical character recognition camera. In a preferred embodiment, the length of the raised text is at least 1 mm, which overcomes potential issues10 WBD (US) 59555578v1in 3D printing. In an alternative embodiment, the lettering is entirely cut through the thickness of the locating socket. Having cutout lettering can further reduce the amount of material required during the 3D printing process.

[0061] The distances between an arch and the locating socket may be varied as each arch has a unique anatomical shape. Thermoforming digital software in combination with the lettering are used to determine a distance for each arch. Based on a known location of the arch, the software ensures the lettering is showing when it merges one or more locating features with the arch.

[0062] The thermoform plate also has a plurality of holes, which allow for air that may get trapped between the thermoforming material and the locator plate to escape during the thermoforming process allowing for a more secure fit. In some embodiments, a vacuum system can be incorporated into the thermoforming system that can provide suction through the smaller holes to assist with holding the polymeric material securely to the thermoform plate. For example, the numerous smaller holes within the thermoform plates are connected to a vacuum suction and are used during the thermoforming and milling / cutting process to further secure the thermoform material. The vacuum / suction holes are not limited in diameter and can vary based on the desired thermoforming system utilized. In an example, the diameter may range from 0.1 mm to 1 mm. In a preferred example, the diameter may be approximately 0.7 mm.

[0063] After the dental model has been secured to the locator plate, a polymeric material can be thermoformed over the dental model, as depicted in FIG.3 in a thermoforming system. In the thermoforming system, a polymer sheet is placed over the molding device and heated under pressure to form an orthodontic aligner precursor 370 on the dental model. When the thermoforming polymeric material is exposed to heat, the material becomes more pliable, which allows the material to mold and take the shape of the dental model when adequate pressure is applied. The orthodontic aligner precursor 370 comprises the orthodontic aligner 380 and excess thermoformed polymer 375 at least partially surrounding the orthodontic aligner.

[0064] The polymeric material is a thin thermoformable material. The thickness of the polymeric material is not particularly limited but should be of sufficient thickness to thermoform around a dental model. Preferably, the polymeric material is less than 5 mm11 WBD (US) 59555578v1thick. More preferably, the thickness of the polymeric material may be from about 0.05 to about 5 mm thick.

[0065] Examples of thermoforming materials include but are not limited to polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), thermoplastic polyurethane (TPU), polyvinyl chloride (PVC), and other biocompatible polymers with suitable elasticity and plasticity for thermoforming.

[0066] The polymeric material can include, for example, a multilayer polymeric material such as those described in US Patent Number 10,549,511; US Patent Number 10,870,263; US Patent Number 10,987,907; US Patent Number 11,325,358; US Patent Number 10,946,630; US Patent Publication No.2022 / 0118747; PCT Application No. PCT / US2020 / 065928; PCT Application No. PCT / US2022 / 025306; and Provisional US Patent Application No. 63 / 354,998; all of which are incorporated by reference in their entirety.

[0067] After the polymeric material is cured, the orthodontic aligner precursor needs to be cut to separate the orthodontic aligner from the excess thermoformed polymer. Prior to cutting the orthodontic aligner precursor, the dental model and the orthodontic aligner precursor are transferred to a separation system. The separation system can be configured to automatically remove the orthodontic aligner precursor from the dental model. Removal of the dental model prior to cutting prevents debris and impurities from the dental model from contaminating the orthodontic aligner.

[0068] After the thermoforming process is completed, the dental model, with the orthodontic aligner precursor attached to the model, is transferred to the separation system. The dental model is removed from the thermoform plate by unlocking the dental model from the locking system. The unlocked dental model, with the attached orthodontic aligner precursor, is then transferred to the separation system, where the orthodontic aligner precursor is automatically separated from the dental model.

[0069] In one aspect of the disclosure, the dental model 100 is locked to the thermoform plate 200 using an elongated bar 300, as depicted in FIG.2B. After thermoforming is completed, the dental model can be removed from the thermoforming plate by unfastening the elongated bar or the holding element base from the thermoforming plate. The dental model, with the attached orthodontic aligner precursor material can be conveyed to the separation system. Preferably, the dental model / orthodontic aligner precursor is conveyed to12 WBD (US) 59555578v1the separation system without any contact with the orthodontic aligner. The only contact made during transport is with the excess thermoformed material.

[0070] In another aspect of the disclosure, the dental model 100 is locked to the thermoform plate 200 using a rotating holding element 350, as depicted in FIG.2C. After thermoforming is completed, the dental model can be removed from the thermoforming plate by rotating the rotating holding element to an unsecured position. The dental model, with the attached orthodontic aligner precursor material can be lifted from the thermoforming plate when the rotating holding element in in the unsecured position. The removed dental model / orthodontic aligner precursor can be conveyed to the separation system. Preferably, the dental model / orthodontic aligner precursor is conveyed to the separation system without any contact with the orthodontic aligner. The only contact made during transport is with the excess thermoformed material.

[0071] FIG.4A shows a cross-sectional side view of a separation system 400 before the dental model is separated from the orthodontic aligner precursor, according to an embodiment of the present disclosure. In this example embodiment, the separation system 400 includes a separator plate 401 and a clamping system. The clamping system includes a clamp platform 405, and a clamp ring 407. In this embodiment, an assembly including a dental model and thermoformed aligner material is secured to the separator plate 401 using the locking system 403, which was used to secure the dental model to the thermoform platform The excess thermoformed material 409 from the orthodontic aligner precursor extends beyond the footprint of the separator plate 401 and onto the clamp platform 405 when the dental model is attached to the separator plate. The clamp ring 407 can then be secured over both the excess thermoformed material 409 and a portion of the clamp platform 405 to secure the orthodontic aligner precursor onto the clamp platform 405. In the embodiment shown in FIG.4A, the clamp ring 407 is a sealed lid that can form a sealed separation chamber 411 above the thermoformed aligner material. In embodiments where the clamp ring 407 includes a sealed lid, the sealed separation chamber 411 can be depressurized in order to assist with the separation of the thermoformed aligner material from the dental model.

[0072] FIG.4B shows a cross-sectional side view of a separation system 400 after the dental model is separated from the orthodontic aligner precursor, according to an embodiment of the present disclosure. In the example shown in FIG.4B, the separator plate13 WBD (US) 59555578v1401 has been retracted downward, perpendicular to the top surface of the separator plate 401. Because the orthodontic aligner precursor is clamped in place between the clamp platform 405 and the clamp ring 407, the orthodontic aligner precursor remains substantially in place while the dental model, locked to the separator plate by the locking system 403, is pulled downward. One skilled in the art will appreciate that the downward force pulling the separator plate 401 and / or separator unit can be achieved by any suitable mechanical power source. As discussed above, in optional embodiments where the clamp ring 407 includes a closed lid, a negative pressure within the sealed separator chamber 411 can assist with the separation. Once the dental model has been separated from the orthodontic aligner precursor, the clamp ring 407 can be removed to release the orthodontic aligner precursor for further processing (e.g., cutting, polishing, inspection, packaging, etc.).

[0073] FIG.5A shows a cross-sectional side view of an alternative separation system 500 after the dental model is separated from the orthodontic aligner precursor, according to an embodiment of the present disclosure. In the example shown in FIG.5A, the separation system includes a separator plate 501 that can tilt or lean with respect to the clamp platform 505. In some embodiments, the separator plate can tilt in any desired direction in order to reduce stresses applied to the orthodontic aligner precursor during separation. In one example embodiment, the separator plate 501 can tilt within a certain range of angles in order to allow more smooth separation of the dental model from the orthodontic aligner precursor. Allowing the separator plate 501 and / or separator unit to angulate in this way can prevent stress damage to the orthodontic aligner material during separation. In some embodiments, the separator plate 501 can tilt at angles between about 0° to about 20°, or between about 0° to about 15°, or between about 0° to about 10°, or between about 0° to about 5°, with respect to the upper surface of the clamp platform 505. The ability of the separator plate 501 to tilt slightly can improve separation, especially on complex cases with overhanging teeth, bite ramps, engagers, or other orthodontic features. The tilting ability of the separator plate 501 can be achieved in a number of different ways, including having one or more spring-loaded supports underneath the separator plate 501 that can compress or extend depending on which portions of the orthodontic aligner material have gripped more strongly to the dental model. In one embodiment, the separator plate 501 can be pulled downward by a central force that is located substantially at the center of the separator plate 501, and two or more spring-loaded supports can be arranged around the edge and underneath of the separator plate. As the14 WBD (US) 59555578v1separator plate 501 is pulled downward, it can tilt within a certain range of angles in order to more smoothly ease the dental model out from the aligner material.

[0074] FIG.5B shows a cross-sectional side view of an example separation platform, according to an embodiment of the present disclosure. In this example embodiment, the separator plate 501 can be supported from below by flexible support structures 511 that allow the separator plate 501 to tilt or angulate while the dental model is being separated from the thermoformed film. In some embodiments, the flexible support structures 511 can include two or more spring loaded supports below the separator plate. The flexible support structures 511 can include telescoping cylinders that house springs, in some embodiments. In the example shown in FIG.5B, two cylindrical spring loaded flexible support structures 511 are shown on opposite sides of the separator plate 501. However, additional designs for the flexible support structures 511 can be implemented, and more or fewer flexible support structures can be used and arranged in different locations or patterns.

[0075] FIG.6 shows a cross-sectional side view of another example separation system 600 before the dental model is separated from the orthodontic aligner precursor, according to an embodiment of the present disclosure. In this example embodiment, the separation system 600 includes a separator plate 601, a clamp platform 605, and a clamp 607. A locking system 603 secures the dental model to the separator plate. In the example embodiment shown in FIG.6, clamp 607 does not include a closed lid (as opposed to the example embodiment shown in FIGS.4A-4B). The clamp 607 can be an annular ring that clamps down on a portion of the excess thermoformed material 609 at the clamp platform 605. In other embodiments, the clamp 607 can have a rectangular footprint, or any other suitable geometry, and is not necessarily cylindrical.

[0076] FIG.7 shows a cross-sectional side view of another example separation system 700 before the dental model is separated from the orthodontic aligner precursor, according to an embodiment of the present disclosure. In this example embodiment, the separation system 700 does not include a separator plate. Instead, the thermoform plate 715 is transported from the thermoform system to the separation system after the orthodontic aligner precursor is formed on the dental model. A locking system 703 secures the dental model to the thermoform plate. The separation system, in this embodiment, includes a clamp ring 707 having a sealed lid that can form a sealed separation chamber 711 above the orthodontic aligner precursor. In the depicted embodiment, the sealed separation chamber 711 can be15 WBD (US) 59555578v1depressurized to create a vacuum that pulls the orthodontic aligner precursor, specifically, the excess thermoformed material 709, against the clamp ring 707. The force of the vacuum applied to the orthodontic aligner precursor is sufficient to allow the dental model to be removed from the orthodontic aligner precursor. In an embodiment of the present disclosure, the orthodontic aligner precursor is removed from the dental model by moving the thermoform plate 715 away from the clamp ring, while a vacuum is created in the separation chamber 711.

[0077] In one embodiment, the present technology includes a method of making an orthodontic aligner. The method begins by preparing a dental model for thermoforming. Dental models may be made by printing a 3D model. This model may include a positive model of a dental arch and may also include a 3D printed locating socket in some embodiments.

[0078] A thermoform plate having locating features as described herein is next provided for securing the dental model to the thermoform plate. A locating feature can include any feature that assists in locating and securing the dental model to the plate. The thermoform plate may also include locator cones, which are concave conical indentations in the locator plate, that further assist in aligning the locator plate correctly.

[0079] Once the dental model is secured to the thermoform plate and in the proper position, the thermoforming material may be thermoformed over the dental model. The thermoforming material is preferably a polymer / thermoplastic sheet or film that is biocompatible and moldable over dental models once sufficient heat and / or pressure is applied. The thermoformed polymer is placed over the entire thermoform plate, encapsulating the dental model, the locating socket, the locating feature, and the holding element, as shown in FIG.3.

[0080] The next step in the process is to separate the thermoformed polymer from the dental model / thermoform plate. In one aspect of the present disclosure, the dental model is removed from the thermoform plate by unlocking the dental model from the locking system. The unlocked dental model, with the attached orthodontic aligner precursor, is then transferred to the separation system, where the orthodontic aligner precursor is automatically separated from the dental model. Preferably, the dental model / orthodontic aligner precursor is conveyed to the separation system without any contact with the orthodontic aligner. The only contact made during transport is with the excess thermoformed material.16 WBD (US) 59555578v1

[0081] In one aspect of the present disclosure, the separation system includes a separation plate and a clamping system. The clamping system includes a clamp platform and a clamp ring. The dental model / orthodontic aligner precursor is attached to the separation plate with the excess thermoformed polymer positioned between the clamp platform and the clamp ring. To remove the orthodontic aligner precursor from the dental model, the separation plate is moved away from the clamp platform.

[0082] In an alternate aspect of the present disclosure, to remove the orthodontic aligner precursor without damaging the precursor, the thermoform plate is moved to a separation system. The separation system includes clamp ring having a sealed separation chamber which can be positioned above the thermoform plate. Once positioned in the separation system the clamp ring contacts a portion of the excess thermoformed polymer of the orthodontic aligner precursor. A vacuum is created within the sealed separation chamber to fix the excess thermoformed polymer to the clamp ring. In some embodiments, the pressure within the sealed separation chamber is reduced a sufficient amount to hold the orthodontic aligner precursor in place during the separation process. Once the orthodontic aligner precursor is secured, the thermoform plate is moved away from the clamp platform, separating the orthodontic aligner precursor from the dental model. The locking system secures the dental model against the thermoform plate to inhibit the dental model from being pulled off the thermoform plate during the separation process.

[0083] In an embodiment, the clamp ring contacts the excess thermoformed material but does not contact the orthodontic aligner formed over the dental model, as depicted in FIG.7. This process has the advantage of removing the thermoformed plastic from the thermoform plate without contacting the orthodontic aligner, reducing or eliminating the chance of damaging the aligner during the separation process.

[0084] The separated thermoformed polymer includes the orthodontic aligner attached to the excess thermoformed polymer that covered the thermoform plate, as shown in FIG.8. The orthodontic aligner is then cut from the orthodontic aligner precursor. The orthodontic aligner can be cut from the thermoformed polymer using a mechanical or laser cutting device.

[0085] In one aspect of the present disclosure, the cutting system comprises a support plate having a locating feature extending from a top surface of the thermoform plate. The orthodontic aligner precursor includes a locating socket having a shape complementary to the locating feature. The orthodontic precursor is positioned on the cutting system support plate such that the locating socket mates with the locating feature on the support plate prior to17 WBD (US) 59555578v1cutting. The locating socket of the orthodontic aligner precursor is formed from the polymer sheet that contacts the locating feature of the dental model. Use of a locating feature on a platform of the cutting system, can ensure that the orthodontic aligner precursor is properly aligned on the cutting system platform prior to cutting.

[0086] In addition to a method, the present technology includes an embodiment of a system for forming an orthodontic aligner. The system includes: a loading system configured to assemble a molding device; a thermoforming system configured to form a polymer sheet over the over the molding device to form an orthodontic aligner on the dental model; a separation system configured to remove an orthodontic aligner from the dental model. The system can be automated through the use of a conveyance system configured to transport the molding device from the loading system to the thermoforming system and from the thermoforming system to the separation system.

[0087] A first orthodontic aligner forming system and method is depicted in FIG.9. In the first step of the process, a plurality of dental models are sent to a loading system. At the loading system, the dental models are attached to thermoform plates such that one dental model is attached to one thermoform plate. The loading system can include a mechanical loading device to automatically couple the dental model to the thermoform plate. When coupling the dental model to the thermoform plate, the loading system secures the dental model to the thermoform plate using a holding element. The dental model can be slid under the holding element as depicted in FIG.9, or a holding element can be rotated into a securing position, as depicted in FIG.2C.

[0088] Once the dental model is secured to the thermoform plate, the thermoform plate is transferred to the thermoforming system. The dental model can be transported to the thermoforming system via a conveyance system, as shown in FIG.9.

[0089] The thermoforming system includes a dispensing system for dispensing a thermoplastic polymer sheet onto the dental model and thermoform plate. The thermoforming system also includes a heat source for thermoforming the polymer sheet over the dental model and the thermoform plate. The heat source should sufficiently heat the thermoforming material such that the material molds over a dental model. The temperature at which heat is applied is dependent on the thermoforming material used in the process. The thermoforming process forms an orthodontic aligner precursor that includes an orthodontic aligner and excess thermoformed polymer at least partially surrounding the orthodontic aligner.18 WBD (US) 59555578v1

[0090] Once the thermoplastic polymer sheet is completely cured, the thermoform plate with the dental model and orthodontic aligner precursor is transferred to the separation system. The thermoform plate can be transferred to the separation system via a conveyance system as shown in FIG.9.

[0091] The separation system includes a clamping system that includes a clamp ring having a sealed separation chamber, as depicted in FIG.7. The clamp ring contacts the excess thermoformed polymer to secure the orthodontic aligner precursor in the clamping system. While a vacuum is created in the sealed separation chamber, the movable support is moved away from the vacuum cap, separating the orthodontic aligner precursor from the thermoform plate and dental model.

[0092] After separation of the thermoformed polymer from the thermoform plate and the thermoformed polymer is transported to a cutting system. The cutting system can include a laser cutter or a mechanical cutter. In the cutting system the orthodontic aligner is cut from the excess thermoformed polymer. The thermoformed polymer can be transferred from the separation system to the cutting system by the conveyance system. The conveyance system can be used to automate the entire process from the loading of the dental models onto the thermoform plate through the cutting process.

[0093] A second orthodontic aligner forming system and method is depicted in FIG.10. In the first step of the process, a plurality of dental models are sent to a loading system. At the loading system, the dental models are attached to thermoform plates such that one dental model is attached to one thermoform plate. The loading system can include a mechanical loading device to automatically couple the dental model to the thermoform plate. When coupling the dental model to the thermoform plate, the loading system secure the dental model to the thermoform plate using a holding element. The holding element can be rotated into a securing position, as depicted in FIG.2C. The use of a holding element having a quick release and hold mechanism allows easy removal and securing of the dental model to the thermoform plate.

[0094] Once the dental model is secured to the thermoform plate, the thermoform plate is transferred to the thermoforming system. The thermoforming system includes a dispensing system for applying a thermoplastic polymer sheet onto the dental model and the thermoform plate. The thermoforming system also includes a heat source for thermoforming a polymer sheet over the dental model and the thermoform plate. The heat source should sufficiently19 WBD (US) 59555578v1heat the thermoforming material such that the material molds over a dental model. The temperature at which heat is applied is dependent on the desired thermoforming material.

[0095] Once the thermoplastic polymer is completely cured, the dental model and thermoformed polymer are removed from the thermoform plate. The thermoformed polymer and dental model is then transferred to a separation system. The thermoformed polymer / dental model can be transferred to the separation system via a conveyance system. This step differs from the first process and system in that the thermoformed polymer and dental model are removed from the thermoform plate and transferred to the separation system. In contrast, the first process transfers the thermoform plate with the thermoformed polymer and dental model to the separation system.

[0096] The separation system includes a movable support and a clamping system as depicted in FIGS.4B and 4C. The dental model / thermoformed polymer is attached to a movable support, while the clamping system secures the orthodontic aligner precursor to the clamping platform. The movable support can have a holding element similar to the holding element used during the thermoforming process. The holding element holds the dental model against the movable support. To separate the orthodontic aligner material from the dental model, the movable support is moved away from the clamping platform, as discussed with respect to FIG.4A and 4B.

[0097] After separation of the orthodontic aligner precursor from the dental model, the orthodontic aligner precursor is transported to a cutting system. The cutting system can include a laser cutter or a mechanical cutter. In the cutting system the orthodontic aligner is cut from the excess thermoformed polymer. The orthodontic aligner precursor can be transferred from the separation system to the cutting system by the conveyance system. The conveyance system can be used to automate the entire process from the loading of the dental models onto the thermoform plate through the cutting process.

[0098] The devices, systems and methods described herein offer a number of advantages over exiting methods of forming orthodontic aligners. The devices, systems and methods described herein make it possible to automate the separation process despite the variety of different dental models due to human anatomy. With this approach, there is a comparatively low risk of damage to the model and the aligner. In addition, the separation method does not leave an impression on the aligner. Another advantage is that no additional material is required for the dental models.20 WBD (US) 59555578v1

[0099] Specific embodiments and methods of securing thermoforming models have been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the disclosure. Moreover, in interpreting the disclosure, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.21 WBD (US) 59555578v1CLAIMS What is claimed is: 1. A system for thermoforming an orthodontic aligner, the system comprising: a loading system configured to automatically assemble a molding device, the molding device comprising: a thermoform plate for receiving and securing individually unique dental models, the thermoform plate comprising: a locating feature extending from a top surface of the thermoform plate; and a locking system; and a dental model positioned on the thermoform plate, wherein the dental model is a positive model of a dental arch, and wherein the dental model comprises a locating socket having a shape complementary to the locating feature; wherein the dental model is positioned on the thermoforming plate such that the locating socket mates with the locating feature when assembled; and wherein the locking system secures the dental model to the thermoform plate during use; a thermoforming system configured to form a polymer sheet over the molding device to form an orthodontic aligner precursor, on the dental model, wherein the orthodontic aligner precursor comprises the orthodontic aligner and excess thermoformed polymer at least partially surrounding the orthodontic aligner; a separation system configured to automatically remove an orthodontic aligner precursor from the dental model; and at least one conveyance system configured to transport the molding device from the loading system to the thermoforming system and / or from the thermoforming system to the separation system. 2. The system of claim 1, wherein the locking system provides sufficient force to the dental model to prevent the dental model from being pulled away from the thermoform plate22 WBD (US) 59555578v1

Claims

when the orthodontic aligner precursor is removed from the dental model in the separation system.

3. The system of claim 1, wherein the locking system comprises a holding element coupled to the top surface of the thermoform plate, wherein the holding element comprises an elongated bar that is coupled to the thermoform plate and contacts a portion of the locating socket and / or the locating feature.

4. The system of claim 1, wherein the locking system comprises a holding element, wherein the holding element is partially disposed in a body of the thermoforming plate, wherein the holding element can be rotated from a first position, within the body of the thermoforming plate, to a second position in which a portion of the holding element contacts a portion of the locating socket and / or the locating feature.

5. The system of claim 1, wherein the separation system comprises a separation plate and a clamping system, the clamping system comprising a clamp platform and a clamp ring, wherein the dental model is attached to the separation plate, and a portion of the excess thermoformed polymer is fixed in place between the clamp platform and the clamp ring.

6. The system of claim 5, wherein the separation plate is movable away from the clamp platform to separate the orthodontic aligner precursor from the dental model.

7. The system of claim 5, wherein the separation plate is movable in a linear direction away from the clamp platform.

8. The system of claim 5, wherein the separation plate can tilt with respect to the clamp platform.

9. The system of claim 1, wherein the separation system comprises a clamping system, the clamping system comprising a clamp ring having a sealed separation chamber, wherein the thermoform plate, with the dental model and orthodontic aligner precursor attached, is positioned on the separation system such that the clamp ring contacts a portion of the excess thermoformed polymer such that the excess thermoformed polymer is fixed in place between the clamp ring and the thermoform plate.

10. The system of claim 9, wherein the excess thermoformed polymer is fixed in place to the clamp ring by application of a vacuum to the orthodontic aligner precursor within the sealed separation chamber.23 WBD (US) 59555578v111. The system of claim 1, further comprising a cutting system configured to produce the orthodontic aligner from the orthodontic aligner precursor by cutting off the excess thermoformed polymer.

12. The system of claim 11, wherein the cutting system comprises a laser cutting device.

13. The system of claim 11, wherein the cutting system comprises a support plate having a locating feature extending from a top surface of the thermoform plate, wherein the orthodontic aligner precursor comprises a locating socket having a shape complementary to the locating feature, and wherein the orthodontic precursor is positioned on the support plate such that the locating socket mates with the locating feature on the support plate prior to cutting.

14. The system of claim 13, wherein the locating socket is formed from the polymer sheet that contacts the locating feature of the dental model.

15. A method for thermoforming an orthodontic aligner, the method comprising: obtaining a molding device, the molding device comprising: a thermoform plate for receiving and securing individually unique dental models, the thermoform plate comprising: a locating feature extending from a top surface of the thermoform plate; and a locking system that secures the dental model to the locating feature during use; and; and a dental model positioned on the thermoform plate, wherein the dental model is a positive model of a dental arch, and wherein the dental model comprises a locating socket having a shape complementary to the locating feature; wherein the dental model is positioned on the thermoforming plate such that the locating socket mates with the locating feature; thermoforming a polymer sheet over the over the molding device to form an orthodontic aligner precursor, on the dental model, wherein the orthodontic aligner precursor comprises the orthodontic aligner and excess thermoformed polymer at least partially surrounding the orthodontic aligner;24 WBD (US) 59555578v1moving the orthodontic aligner precursor to a separation system, the separation system comprising a clamping system; and clamping the orthodontic aligner precursor within the clamping system; and separating the orthodontic aligner precursor from the dental model by moving the dental model away from the clamping system.

16. The method of claim 15, wherein the locking system provides sufficient force to the dental model to prevent the dental model from being pulled away from the thermoform plate when the orthodontic aligner precursor is removed from the dental model in the separation system.

17. The method of claim 15, wherein the locking system comprises a holding element coupled to the top surface of the thermoform plate, wherein the holding element comprises an elongated bar that is coupled to the thermoform plate and contacts a portion of the locating socket and / or the locating feature.

18. The method of claim 15, wherein the locking system comprises a holding element, wherein the holding element is partially disposed in a body of the thermoforming plate, wherein the holding element can be rotated from a first position, within the body of the thermoforming plate, to a second position in which a portion of the holding element contacts a portion of the locating socket and / or the locating feature.

19. The method of claim 15, wherein moving the orthodontic aligner precursor to a separation system comprises: removing the dental model with the attached orthodontic aligner precursor from the thermoform plate; and transferring the dental model with the attached orthodontic aligner precursor to the separation system.

20. The method of claim 19, wherein the separation system comprises a separation plate and a clamping system, the clamping system comprising a clamp platform and a clamp ring, wherein the method further comprises attaching the dental model to the separation plate and clamping a portion of the excess thermoformed polymer between the clamp platform and the clamp ring.25 WBD (US) 59555578v121. The method of claim 20, further comprising moving the separation plate away from the clamp platform to separate the orthodontic aligner precursor from the dental model.

22. The method of claim 15, wherein moving the orthodontic aligner precursor to a separation system comprises moving the thermoform plate with the dental model and orthodontic aligner precursor attached to the separation system.

23. The method of claim 22, wherein the separation system comprises a separation plate and a clamping system, the clamping system comprising a clamp ring having a sealed separation chamber, wherein the method further comprises: positioning the thermoform plate, with the dental model and orthodontic aligner precursor attached, in the separation system such that the clamp ring contacts a portion of the excess thermoformed polymer; creating a vacuum within the sealed separation chamber, wherein the excess thermoformed polymer is fixed in place to the clamp ring by the application of the vacuum; and moving the thermoform plate away from the clamp platform to separate the orthodontic aligner precursor from the dental model.

24. The method of claim 15, further comprising cutting off the excess thermoformed polymer at a cutting system to produce the orthodontic aligner from the orthodontic aligner precursor.

25. The method of claim 24, wherein the cutting system comprises a laser cutting device.

26. The method of claim 24, wherein the cutting system comprises a support plate having a locating feature extending from a top surface of the thermoform plate, wherein the orthodontic aligner precursor comprises a locating socket having a shape complementary to the locating feature, and wherein the orthodontic precursor is positioned on the support plate such that the locating socket mates with the locating feature on the support plate prior to cutting.

27. The method of claim 26, wherein the locating socket is formed from the polymer sheet that contacts the locating feature of the dental model.

28. The method of claim 15, wherein obtaining the molding device comprises assembling the molding device at a molding system, and wherein thermoforming the polymer sheet over26 WBD (US) 59555578v1the molding device is performed at a thermoforming system, and wherein separating the orthodontic aligner precursor from the dental model is performed at a separation system.

29. The method of claim 28, wherein one or more conveyance systems transport the molding device from the loading system to the thermoforming system and / or from the thermoforming system to the separation system.

30. A thermoform plate for receiving and securing dental models, the thermoform plate comprising: a locating feature extending from a top surface of the thermoform plate; and a locking system that secures the dental model to the thermoform plate during use.

31. The thermoform plate of claim 30, wherein the locking system provides sufficient force to the dental model to prevent the dental model from being pulled away from the thermoform plate when an orthodontic aligner precursor is removed from the dental model during use.

32. The thermoform plate of claim 30, wherein the locking system comprises a holding element coupled to the top surface of the thermoform plate, wherein the holding element comprises an elongated bar that is coupled to the thermoform plate and contacts a portion of the locating socket and / or the locating feature.

33. The thermoform plate of claim 30, wherein the locking system comprises a holding element, wherein the holding element is partially disposed in a body of the thermoforming plate, wherein the holding element can be rotated from a first position, within the body of the thermoforming plate, to a second position in which a portion of the holding element contacts a portion of the locating socket and / or the locating feature.

34. A molding device for forming an orthodontic aligner, the molding device comprising: a thermoform plate for receiving and securing individually unique dental models, the thermoform plate comprising: a locating feature extending from a top surface of the thermoform plate; and a locking system that secures the dental model to the thermoform plate during use; and27 WBD (US) 59555578v1a dental model positioned on the thermoform plate, wherein the dental model is a positive model of a dental arch, and wherein the dental model comprises a locating socket having a shape complementary to the locating feature; wherein the dental model is positioned on the thermoforming plate such that the locating socket mates with the locating feature; and wherein the holding element covers at least a portion of the locator tab and the locating feature to hold the dental model against the thermoforming plate, during use.

35. The molding device of claim 34, wherein the locking system provides sufficient force to the dental model to prevent the dental model from being pulled away from the thermoform plate when an orthodontic aligner precursor is removed from the dental model during use.

36. The molding device of claim 34, wherein the locking system comprises a holding element coupled to the top surface of the thermoform plate, wherein the holding element comprises an elongated bar that is coupled to the thermoform plate and contacts a portion of the locating socket and / or the locating feature.

37. The molding device of claim 34, wherein the locking system comprises a holding element, wherein the holding element is partially disposed in a body of the thermoforming plate, wherein the holding element can be rotated from a first position, within the body of the thermoforming plate, to a second position in which a portion of the holding element contacts a portion of the locating socket and / or the locating feature.28 WBD (US) 59555578v1