Dental instrument, material construction and improved treatment system

Abstract

Improved dental instruments and polymeric sheet compositions are disclosed. The polymeric sheet composition may be used to make a dental instrument having an outer layer comprising a material having a modulus of about 1,000 MPA to 3,000 MPA ("hard") and an inner core comprising one or more elastomeric materials having a modulus of about 25 MPa to 500 MPa ("soft") and a thickness of greater than about 250 microns, the elastomeric materials having a modulus of about 25 MPa to about 500 MPa ("soft") and a thickness of greater than about 250 microns, compared to currently available materials and dental instruments, the dental instrument exhibits improved flexibility and strength, as well as better soil and tear resistance.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 354,998, filed on June 23, 2022, which is incorporated by reference in its entirety for all purposes. Technical Field

[0003] The present disclosure relates generally to systems and methods for sequentially moving teeth in orthodontic treatment, and more particularly to a treatment protocol in combination with aligners and materials having certain properties for providing enhanced tooth movement and which provides a significant advancement to the state of the art in clear aligner therapy. Background Art

[0004] Clear aligner therapy involves the application of a series of one or more plastic "aligner" shells that fit onto the teeth. Each shell is formed so that the shell is displaced from one or more teeth so that the shell applies a force to the one or more teeth to move the one or more teeth to a desired position that is different from the initial position of the one or more teeth. The shells can be designed to move the teeth in different directions, such as laterally, or rotationally, or in the buccal or lingual direction, or to produce intrusion or extrusion.

[0005] The shells are typically constructed of a plastic sheet that is thermoformed over a tooth model representing each planned stage, or they can be manufactured by 3D printing. The shells (also commonly referred to as positioners or aligners) can be a single layer of material, such as polyester copolymers or polyurethane, or can be a multilayer structure. Examples of single layer structures include PETG materials (such as Essix Ace sold by Dentsply) and PETG aligners. TM ) and ridged polyurethanes (such as Zendura sold by Bay Materials, LLC. TM ). Examples of multi-layer materials include SmartTrack sold by Align technology TM Aligner and Zendura FLX sold by BayMaterials, LLC TM, see, for example, U.S. Patent 9,655,691, U.S. Patent 9,655,693, U.S. Patent 10,549,511, U.S. Patent 10,946,630, U.S. Patent 10,870,263, and U.S. Patent 10,987,907, all of which are incorporated by reference for all purposes. Other different multilayer aligner materials have been described in International Patent Publication Nos. WO 2020 / 225651 and WO2021025967A1, all of which are incorporated by reference.

[0006] In some cases, aligner therapy may involve the use of more than one type of material, such as two layers of “hard / soft” material (see, for example, orthocaps: https: / / www.orthocaps.com / was-is-orthocaps / #sec1) and a single layer of “hard” material, or aligner therapy may use sequential instruments with different thicknesses (e.g., 0.5mm, 0.625mm, 0.75mm), as in, for example, the CA Aligner system promoted by Scheu-Dental (Germany).

[0007] In clear aligner therapy, treatment planning is typically done digitally, with specific amounts of movement planned for each tooth in each step (which may include one or more teeth that do not move at all). Common tooth movements include simple translation (specified in mm / stage), rotation (specified in degrees / stage), tilt (specified in degrees / stage), and can be in the buccal, lingual, mesial, distal, or axial directions.

[0008] Due to the stress / strain properties of prior art plastics (e.g., polyesters and rigid polyurethanes) and the biomechanics of tooth movement, current aligner therapy has limited the amount of tooth movement at each stage to a maximum of approximately 0.3 mm. Attempted larger movements typically cause discomfort to the patient, may damage the tooth roots or jawbone, and generally result in inaccurate movement. Furthermore, it is well known that attempting larger tooth movements at each stage may result in increasing lag in tooth movement. In the case of the "CA Aligner System," larger movements can be programmed, but it should be understood that the actual movement is designed to be achieved through three consecutive aligners so that the effective movement at each stage is still less than approximately 0.3 mm. Summary of the invention

[0009] Embodiments of the present disclosure provide treatment systems for moving one or more teeth that advantageously enable a reduction in the number of aligners required to accomplish orthodontic movement and advantageously allow an expanded range of motion without causing pain or root damage. Embodiments of the present disclosure advantageously enable predictable movement of teeth by a greater amount per aligner treatment session. Embodiments of the present disclosure advantageously enable the provision of improved aligners and treatment plans, thereby enabling a reduction in the amount of material used to manufacture the device and / or a reduction in the time to manufacture the device.

[0010] In some embodiments, the dental appliance is adapted to sequentially position one or more teeth in fewer stages than previous aligner therapy plans. For example, various embodiments enable a reduction in the number of aligners used in a therapy treatment plan, such as determined by a dental provider or automatically determined using dental treatment planning software, at a rate of tooth movement that is 1.25 to 1.5 times or faster than prior systems.

[0011] According to one embodiment, a system for treating malocclusion is provided, the system being used to move one or more teeth from a first position to at least a second position according to a treatment plan. The system comprises a series of one or more aligners, wherein at least one of the aligners comprises a multilayer structure having at least two outer layers and at least one elastomeric inner layer, wherein the thickness of the elastomeric inner layer is greater than 250 microns up to about 1,000 microns, such as about 300 microns to about 775 microns, and a hardness of about Shore A80 to Shore D65, wherein at least one of the outer layers comprises a polymer having a modulus of about 1,000 MPa to about 3,000 MPa, and wherein the total thickness of the at least two outer layers and the at least one elastomeric inner layer is about 500 microns to about 1,500 microns. In one embodiment, at least one of the aligners is configured and / or designed such that when worn by the patient for a wearing time between 10 and 15 days, at least one tooth of the patient exhibits an excursion movement of between about 0.35 mm and about 0.75 mm in the mesiodistal direction and / or the buccolingual direction, and / or at least one tooth of the patient exhibits a rotation of between about 3.5 degrees and about 7.5 degrees around the axis of the at least one tooth, and / or at least one tooth exhibits a mesiodistal tilting movement of between about 3.5 degrees and about 7 degrees.

[0012] According to another embodiment, a system for treating malocclusion is provided, the system being used to move one or more teeth from a first position to at least a second position according to a treatment plan including two or more stages. The system includes a series of one or more aligners, wherein at least one of the aligners includes a multilayer structure having at least two outer layers and at least one elastomeric inner layer, wherein the thickness of the elastomeric inner layer is greater than 250 microns up to about 775 microns and a hardness of about Shore A80 to Shore D65, wherein at least one of the outer layers comprises a polymer having a modulus of about 1,000 MPa to about 3,000 MPa measured according to ASTM D638, wherein the total thickness of the at least two outer layers and the at least one elastomeric inner layer is about 500 microns to about 1,500 microns. In one embodiment, at least one of the aligners is configured to perform one or more of an excursion movement of at least one tooth, a rotation of the at least one tooth, and a mesiodistal tilting of the at least one tooth over the course of a treatment phase, wherein the excursion movement is between about 0.35 mm and about 0.75 mm in the mesiodistal direction and / or the buccolingual direction, wherein the rotation is between about 3.5 degrees and about 7.5 degrees about the tooth axis, and wherein the mesiodistal tilting movement is between about 3.5 degrees and about 7 degrees.

[0013] In one embodiment, the at least one of the aligners is configured such that when worn by the patient for the wearing time, two or more teeth of the patient each exhibit the offset movement of between about 0.35 mm up to about 0.75 mm.

[0014] In one embodiment, at least one of the aligners is configured such that when worn by the patient for the wearing time, 8, 10, 12 or fewer teeth of the patient each exhibit the excursion movement between about 0.35 mm to about 0.75 mm.

[0015] In one embodiment, the at least two outer layers each comprise a copolyester, a polycarbonate, a polyester polycarbonate blend, a polyurethane, a polyamide, or a polyolefin.

[0016] In one embodiment, the at least one elastomeric inner layer comprises one or more of polyurethane elastomers, polyolefin elastomers, polyester elastomers, styrene elastomers, polyamide elastomers, cycloolefin elastomers, acrylic elastomers, aromatic or aliphatic polyether polyurethanes, and polyester polyurethanes.

[0017] In one embodiment, the at least two outer layers each comprise a copolyester.

[0018] In one embodiment, the modulus of the at least one elastomeric inner layer is about 25 MPa to 500 MPa, such as 25 MPa, or 50 MPa, or 100 MPa, or 250 MPa, etc.

[0019] In one embodiment, the at least one aligner further comprises one or more adhesive layers.

[0020] According to another embodiment, a system for treating malocclusion is provided, the system being used to move one or more teeth from a first position to at least a second position according to a treatment plan, wherein the system comprises a series of two or more aligners, wherein each of the two or more aligners comprises a multilayer structure having at least two outer layers and at least one elastomeric inner layer, wherein the thickness of the elastomeric inner layer is greater than 250 microns up to about 1,000 microns, for example, greater than 300 microns to about 775 microns, and a hardness of about Shore A80 to Shore D65, wherein at least one of the outer layers comprises a polymer having a modulus of about 1,000 MPa to about 3,000 MPa, and wherein the total thickness of the at least two outer layers and the at least one elastomeric inner layer is about 500 microns to about 1,500 microns. In one embodiment, at least one of the aligners is configured and / or designed such that when worn by the patient for a wearing time between 10 and 15 days, at least one tooth of the patient exhibits an excursion movement of between about 0.35 mm and about 0.75 mm in the mesiodistal direction and / or the buccolingual direction, and / or at least one tooth of the patient exhibits a rotation of between about 3.5 degrees and about 7 degrees about the axis of the at least one tooth, and / or at least one tooth exhibits a mesiodistal tilting movement of between about 3.5 degrees and about 7 degrees.

[0021] In one embodiment, each of the two or more aligners is configured such that when worn by the patient for the wearing time, two or more teeth of the patient each exhibit an excursion movement of between about 0.35 mm up to about 0.75 mm.

[0022] In one embodiment, each of the two or more aligners is configured such that when worn by the patient for the wearing time, 8, 10, 12 or fewer teeth of the patient each exhibit an excursion movement of between about 0.35 mm up to about 0.75 mm.

[0023] In one embodiment, the at least two outer layers each comprise a copolyester, a polycarbonate, a polyester polycarbonate blend, a polyurethane, a polyamide, or a polyolefin.

[0024] In one embodiment, at least one elastomeric inner layer of each of the two or more aligners comprises one or more of a polyurethane elastomer, a polyolefin elastomer, a polyester elastomer, a styrene elastomer, a polyamide elastomer, a cycloolefin elastomer, an acrylic elastomer, an aromatic or aliphatic polyether polyurethane, and a polyester polyurethane.

[0025] In one embodiment, the at least two outer layers of each of the two or more aligners each comprise a copolyester.

[0026] In one embodiment, the modulus of at least one elastomeric inner layer of each of the two or more aligners is about 25 MPa to 500 MPa, such as 25 MPa, or 50 MPa, or 100 MPa, or 250 MPa, etc.

[0027] In one embodiment, each of the two or more aligners further comprises one or more adhesive layers.

[0028] In one embodiment, a new aligner therapy treatment plan is determined by reducing the number of treatment sessions in an initial treatment plan to a second plurality of treatment sessions including the series of two or more aligners, the initial treatment plan involving a first plurality of treatment sessions, each treatment session designed to effectuate an excursion movement of less than 0.3 mm to at least one tooth, wherein the number of treatment sessions in the first plurality of treatment sessions is greater than the number of treatment sessions in the second plurality of treatment sessions.

[0029] Reference to the rest of the specification, including the drawings and claims, will provide additional features and advantages of the present invention. Further features and advantages of the present invention and the structure and operation of various embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings. In the accompanying drawings, the same reference numerals indicate the same or functionally similar elements. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The detailed description is described with reference to the accompanying drawings.The use of the same reference numbers in different instances in the description and the drawings may indicate similar or identical items.

[0031] Figure 1A Schematic diagram of a cross-sectional view of a three-layer sheet with a simple ABC configuration. Layer A and layer C can be the same or different materials, and each layer can be composed of one or more materials, or blends or alloys. Layer B can be a single material, a material blend, or an alloy.

[0032] Figure 1Bis a schematic diagram of a cross-sectional view of a multilayer sheet. Each of layers A, B, and C may include a single layer or multiple layers, and each layer may include one or more materials or material blends. Layer A may include more than one layer, such as layers a and a', layer B may include more than one layer, such as layers b and b', and layer C may include more than one layer, such as layers c and c', as shown in FIG. Figure 1B exemplified in .

[0033] Additionally, the multiple layers may include additional tie layers between the different polymers, as is known in the art.

[0034] Figure 2 The elastic modulus and flexural modulus of four different aligner materials are shown.

[0035] Figure 3 An example of a treatment plan according to embodiments herein is shown that includes 3 upper aligners and 2 lower aligners formed using materials of the present disclosure and applied to a patient who was originally planned to use 6 upper aligners and 4 lower aligners (reducing the number of stages by 50%).

[0036] Figure 4 Shown for Figure 5 Summary of tooth movement in a patient's treatment plan.

[0037] Figure 5 An example of a recurrent treatment plan including 1 aligner for a conventional 2-stage treatment plan according to embodiments herein is shown.

[0038] Figure 6 Shown for Figure 5 Summary of tooth movement in a patient's treatment plan.

[0039] Figure 7 An example of an incisor relapse treatment plan including 2 aligners for a conventional 6-stage treatment plan according to embodiments herein is shown.

[0040] Figure 8 Shown for Figure 7 Summary of tooth movement in a patient's treatment plan. DETAILED DESCRIPTION

[0041] The present disclosure relates to materials, systems and methods for moving teeth using one or more transparent aligners, the one or more transparent aligners including aligners having three or more layers, the three or more layers comprising at least two rigid outer materials and one inner elastic material, and the staged movement of one or more teeth is about 0.35 mm to 0.8 mm and / or the rotation of each stage is about 3.5 degrees to 8 degrees. For example, in an embodiment, when continuously worn by a patient or user during the time period, at least one aligner in a set of aligners provides a tooth movement rate of at least one tooth greater than 0.35 mm in a 10-day period, or greater than 0.35 mm in a 14-day period. The movement can be in the mesial / distal direction and / or the buccal / lingual direction.

[0042] Further, in one embodiment, when worn continuously by a patient or user during the time period, at least one aligner in the set of aligners provides a tooth rotation rate of at least one tooth about an axis (e.g., a long axis) of the tooth greater than 0.35 degrees in a 10-day period or greater than 3.5 degrees in a 14-day period. Further, in one embodiment, when worn continuously by a patient or user during the time period (e.g., worn for at least 18 hours per day), at least one aligner in the set of aligners provides a tooth translation rate of at least one tooth about a center of resistance of the tooth greater than 0.35 degrees in a 10-day period or greater than 3.5 degrees in a 14-day period.

[0043] Figure 1A Schematic diagram of a cross-sectional view of a three-layer sheet with a simple ABC configuration. Layer A and layer C can be the same or different materials, and each layer can include one or more materials, or blends or alloys. Layer B can be a single material, a material blend, or an alloy.

[0044] Figure 1B is a schematic diagram of a cross-sectional view of a multilayer sheet. Each layer A, B, and C may include a single layer or multiple layers, and each layer may include one or more materials or material blends. Layer A may include more than one layer, such as layers a and a', layer B may include more than one layer, such as layers b and b', and layer C may include more than one layer, such as layers c and c', as shown in FIG. Figure 1B exemplified in .

[0045] According to various embodiments of this document, Figure 1A Three-layer sheet and Figure 1B The multi-layer sheets can be used to form dental appliances, such as aligners.

[0046] In one embodiment, a composition is provided, comprising at least two outer layers A and C and an intermediate layer B. Layer A and layer C each comprise a polymer (e.g., a thermoplastic polymer) having a modulus of about 1,000 MPa to 3,000 MPa and a glass transition temperature and / or melting point of about 80°C to 180°C, and intermediate layer B comprises at least one elastomer having a modulus of about 25 MPa to about 500 MPa and one or more of a glass transition temperature and / or melting point of about 90°C to about 220°C.

[0047] In one embodiment, layer A and layer C include one or more of a copolyester, a polycarbonate, a polyester polycarbonate blend, a polyurethane, a polyamide, or a polyolefin.

[0048] In an embodiment, the middle layer B includes one or more of polyurethane elastomer, polyolefin elastomer, polyester elastomer, styrene elastomer, polyamide elastomer, cycloolefin elastomer, acrylic elastomer, aromatic or aliphatic polyether polyurethane or polyester polyurethane or polycarbonate polyurethane.

[0049] In one embodiment, the aligner has a tensile modulus of about 600 MPa to about 1000 MPa and a flexural modulus of about 1100 MPa to about 1400 MPa.

[0050] In one embodiment, the aligner may include five or more layers including two or more elastomeric layers (see, e.g., Figure 1B In one embodiment, the total thickness of the elastomeric material is from about 450 microns or 500 microns to 1000 microns or more, or from 650 microns to 1000 microns, or from 750 microns to 1000 microns.

[0051] In one embodiment, one or more teeth may be programmed or staged so that the teeth move during any one stage. For example, in an embodiment, more than 3 but less than 10 teeth are programmed or staged so that the teeth move more than 0.35 mm or more than 0.4 mm per stage. In an embodiment, the maximum movement should be no more than about 7.5 mm or 8.0 mm per stage. Individual or cumulative tooth movement may be in the mesial / distal direction and / or in the buccal / lingual direction.

[0052] Tables 1 and 2 are tables showing motion examples (Table 2) based on aligner material design examples (Table 1), where layer A and layer C are outer layers, and layer B is an inner or middle layer.

[0053] Table 1:

[0054] Layer thickness (micrometers)

[0055]

[0056] *Assuming no more than 10 teeth are moved

[0057] Table 2:

[0058]

[0059] In one embodiment, one or more teeth may be programmed or staged so that the teeth rotate and / or tilt during any one stage. For example, in an embodiment, more than 3 but less than 10 teeth are programmed or staged so that the teeth rotate or tilt more than 3.5 degrees or more than 4 degrees per stage. In an embodiment, the rotation or angular tilt movement should be no more than about 7.5 degrees or 8.0 degrees per stage.

[0060] In one embodiment, one or more teeth may be programmed or staged so that the teeth move axially during any one stage (e.g., extrusion or intrusion movement). For example, in an embodiment, more than 3 but less than 10 teeth are programmed or staged so that the teeth move more than 0.3 mm or more than 0.4 mm per stage.

[0061] To determine the staging of the teeth, treatment planning software implemented on a computer system can be used. The automated treatment planning software takes the initial tooth position and the final tooth position and determines the difference, such as a 1mm or 10mm difference. The software can then be given a "maximum movement limit per stage, such as 0.3mm". The software will then generate intermittent stages (case plans) to move the teeth to that position and orientation. Advantageously, embodiments of the present disclosure are particularly useful for users who may require an adjusted plan with a larger range of tooth movement. Compared to previous aligner therapy plans, embodiments of the present invention enable both the linear and angular range of tooth movement per stage of aligner therapy to be increased, and improve control over the number of stages (e.g., reducing the number of groups of stages in some cases) to produce the desired results (final tooth position and orientation). For example, using the more elastic layer structures described herein, tooth speeds that are 1.5 times or 2.0 times faster for tooth movement are possible.

[0062] In one embodiment, the combined thickness of layer A, layer B, and layer C is from about 250 microns to about 2,000 microns, or from about 500 microns to about 1500 microns.

[0063] In one embodiment, the middle layer B comprises an aromatic polyether polyurethane having a Shore hardness of about A90 to D55, about A85 to D60, or about A80 to D65 and a compression set of less than 35%, wherein the interlayer peel strength between layer A and layer C and layer B is greater than 50N / 2.5cm. "Peel strength" can be measured according to ASTM D3163. The specifications of a useful material, Trilaminate PN 9210 Extrusion-Lamination & Slit Rolls, are: interlayer bonding, ASTM D3163, peel force>50N; 2.54cm. The term "compression set" is used herein with respect to the permanent deformation of a material when a force is applied and removed. Unless otherwise stated, compression set is measured according to ASTM D395-B (ISO 815) at a temperature of 23°C for a specified time of 22 hours.

[0064] Figure 2 The elastic modulus and flexural modulus of five different aligner materials are shown, also as shown in Table 3 below:

[0065] Table 3:

[0066]

[0067] In one embodiment, one or more dental appliances made from a composition or polymer sheet as described herein are provided, each of the one or more dental appliances being conformable to one or more teeth.

[0068] In one embodiment of the dental device, the combined thickness of layer A, layer B, and layer C is from about 300 microns to about 1,500 microns, and the combined thickness of layer A and layer C is from 25 microns to 750 microns, 50 microns to 1000 microns, 100 microns to 700 microns, 150 microns to 650 microns, 100 microns to 200 microns, or 200 microns to about 600 microns. The thickness of layer B is from about 250 microns to about 1000 microns.

[0069] In one embodiment, the elastomeric intermediate layer comprises a polyurethane or polyester elastomer having a hardness of about A80 to D75, A85 to D65, or A90 to D55, for example, A95, A90, A85, A80, A75, D50, D55, D60, D65, or D70.

[0070] In another embodiment, a composition, polymer sheet or dental device having environmental stress resistance is provided, the composition, polymer sheet or dental device comprising at least two outer layers and an elastomeric inner layer, wherein one or more of the outer layers are polyesters or copolyesters having a modulus of about 1,000 MPa to 3,000 MPa, and the inner layer comprises an elastomer having a modulus of about 25 MPa to about 500 MPa, wherein the interlayer peel strength between at least one outer layer and the elastomer is greater than about 50 N / inch.

[0071] In another aspect, a reversibly deformable dental device is provided, wherein the thickness of outer layer A is from about 100 microns to about 250 microns, for example, 100 microns, 125 microns, 150 microns, 175 microns, 200 microns, 225 microns or 250 microns, the thickness of outer layer C is from about 100 microns to about 250 microns, for example, 100 microns, 125 microns, 150 microns, 175 microns, 200 microns, 225 microns or 250 microns, and the thickness of intermediate layer B is greater than about 250 microns, for example, 300 microns to 1000 microns, wherein the combined thickness of layers A, B and C is from 450 microns to 1,500 microns or greater.

[0072] In some embodiments, a thin layer of additional polymer (tie layer) may be present to improve the adhesion of the non-naturally adhesive polymer layers to each other, for example, a maleic anhydride grafted polypropylene layer may be used to increase the adhesion between the polypropylene layer A and the polyester or polyamide layer B. Other bonding materials may include copolymers of ethylene and acrylates and / or vinyl acetate, ethylene grafted maleic anhydride, ethylene copolymerized acrylic acid optionally containing other alpha olefins.

[0073] In some embodiments, a set of one or more dental appliances can be formed by thermoforming a multilayer sheet over a tooth model, wherein the thermoforming is performed at a temperature that is at least greater than the glass transition temperature and / or melting point of the outer layer and greater than or equal to the upper glass transition temperature and / or melting point of at least one inner layer material (e.g., an elastomeric material).

[0074] It will be appreciated that elements of two or more embodiments may be combined.

[0075] In some embodiments, the dental appliance is adapted to sequentially position one or more teeth in fewer stages than previous aligner therapy plans due, at least in part, to the increased elasticity resulting from a combination of layer thickness and hardness properties.

[0076] If one hard outer layer is thinner than the other hard outer layer, thermoforming the thinner hard layer against the form may provide improved contact and conformity to the form, thereby improving comfort, fit, and mechanical coupling.

[0077] In some embodiments, the thickness of the hard outer layer inside the appliance that contacts the teeth is less than the thickness of the other hard layer (eg, asymmetrical).

[0078] In some embodiments, the hard layer in contact with the teeth may be less than about 250 microns thick or as thin as about 50 microns.

[0079] In certain embodiments, the multilayer sheet can be prepared by a variety of means, including but not limited to hot or cold lamination, adhesive lamination, melt lamination, coextrusion, multilayer extrusion or other known methods. The sheet can be completely prepared before being formed into an orthodontic appliance, or a series of individual thermoforming steps can be used to create multiple layers to produce the appliance.

[0080] Thermoforming of sheets to produce test specimens or dental devices can be performed using a "Biostar" pressure former available from Great Lakes Orthodontics using procedures commonly used in the industry. Alternatively, thermoforming can be performed using a roll-fed thermoformer, vacuum former, or other known thermoforming techniques. Thermoforming can be performed using different conditions, forms, or models to vary the stretch ratio and part thickness. Multilayer devices can be manufactured by one or more 3D printing processes or by sequential dip coating, spray coating, powder coating, or similar processes known to be used to produce films, sheets, and 3D structures.

[0081] definition

[0082] The term "dental appliance" is used herein with reference to any device placed in or on a subject's teeth. Dental appliances include, but are not limited to, orthodontic appliances, restorative appliances, retaining appliances, snoring / airway appliances, cosmetic appliances, therapeutic appliances, protective appliances (e.g., mouth guards), and habit-changing appliances. An example of a dental appliance is an aligner, such as a clear aligner.

[0083] The term "flexural modulus" is used herein with reference to the stiffness of a material and / or the resistance of a material to bending deformation. The higher the flexural modulus of a material, the greater its resistance to bending. For isotropic materials, the elastic modulus is the same in any direction measured.

[0084] The term "hardness" is used herein with reference to the Shore Hardness Scale and is measured according to ASTM D 2240 unless otherwise stated. A durometer measures the depth of penetration of a metal pin or prong into the surface of a material. There are different durometer scales, but Shore A and Shore D are commonly used. A material with a higher durometer value will be harder than a material with a lower durometer value. Shore hardness and modulus are often related and if only one value is known by methods described in the art, a conversion can be made by approximation.

[0085] The expressions "modulus", "Young's modulus" and "elastic modulus" are used herein with respect to the stiffness of a material and / or the tensile resistance of a material. The higher the modulus of a material, the greater the rigidity. The flexural modulus and elastic modulus of a material may be the same or different. For isotropic materials such as A, B and C, the component flexural modulus and modulus (which may also be referred to as elastic modulus) are substantially the same, and one or the other may be measured depending on the circumstances. For laminated structures, the elastic modulus and flexural modulus may be significantly different. For polymers, mechanical properties including elastic modulus and other properties may be measured as specified in ASTM D 638. The flexural modulus may be measured by the tests listed in ASTM D790, and units of force per area are used. Unless otherwise indicated, "modulus" refers to the elastic modulus.

[0086] The term "polymer sheet" is used herein interchangeably with the term "plastic sheet".

[0087] The term "about" as used herein with respect to a numerical value means that the value may be within a small percentage (e.g., no more than 10%) of the value, such as within 10% or 5% or 2%, for example "about 50" may include 45 to 55, and about 3000 may include 2700 to 3300.

[0088] The term "shell" is used herein in reference to a polymeric structure that is adapted to a tooth and removably placed over the tooth.

[0089] The term "thermoplastic polymer" is used herein in reference to a polymer that becomes flexible or pliable above a certain temperature and solidifies upon cooling, provided that the heat and pressure do not chemically decompose the polymer.

[0090] The terms "tooth" or "teeth" include natural teeth, including natural teeth that have been modified by fillings or crowns, implant teeth, artificial teeth that are part of a bridge or other fitting secured to one or more natural teeth or implant teeth, and artificial teeth that are part of a removable fitting.

[0091] The term "stage" is used herein to mean one or more steps in a treatment plan, with each "stage" being represented by an aligner. A treatment plan may include one or more stages, e.g., 10 stages, each stage being a proposed tooth movement that translates to an aligner. The wearing duration of a "stage" refers to the length of time that a patient wears a particular set (one or two) of aligners, e.g., 5 days, 7 days, 10 days, or 15 days. Multiple stages are often combined to provide extended and / or multiple tooth movements, rotations, etc.

[0092] Example

[0093] Table 4 below illustrates examples of linear and angular motion that may occur depending on the dimensions of the elastomeric inner layer B.

[0094]

[0095] Table 4

[0096] Table 5 below illustrates an example of stage reduction that may be achieved according to an embodiment.

[0097] Example of a treatment plan

[0098]

[0099] Table 5

[0100] Figure 3 An example of a treatment plan according to an embodiment of the present invention is shown, which includes only 3 upper aligners and 2 lower aligners formed using materials of the present disclosure and applied to a patient who was originally planned to use 6 upper aligners and 4 lower aligners (a 50% reduction in the number of stages). A pre-treatment and post-treatment overlay is also shown from two different angles. The patient did not complain of discomfort during the treatment. Figure 4 And the following Tables 6 and 7 illustrate Figure 3 A summary of the tooth movements planned for the patient in the treatment plan. Movements include uprighting the upper anterior teeth (-ive, Trq, +ive buccal movements), improving the vertical position of the upper teeth (extrusion), and improving tipping movements (mesiodistal angulation).

[0101] Table 6:

[0102]

[0103] Table 7:

[0104]

[0105] Figure 5 An example of a recurrence treatment plan according to an embodiment of the present invention is shown, which includes a conventional 2-stage treatment plan using only 1 aligner. The single aligner is formed using the material of the present disclosure. A superposition of before and after treatment is also shown. The patient did not complain of discomfort during treatment. Figure 6 and Table 8 below illustrates the Figure 5 A summary of tooth movement movements for a patient's treatment plan.

[0106] Table 8:

[0107]

[0108] Figure 7An example of an incisor recurrence treatment plan according to an embodiment of the present invention is shown, which includes only 2 aligners for a conventional 6-stage treatment plan. The aligner table is formed using the material of the present disclosure. The patient did not complain of discomfort during treatment. Figure 8 and Table 9 below illustrates the Figure 7 Summary of tooth movement in a patient's treatment plan.

[0109] Table 9:

[0110]

[0111] Example:

[0112] Tooth movement was evaluated using materials and treatment plans according to embodiments of the present invention. One group of patients was treated with aligners made of prior art materials (Zendura FLX, available from Bay Materials, LLC) and a typical aligner phase plan of 0.3 mm / 3 degrees, with a wear period of 14 days per aligner, and the treatment is referred to as FLX treatment below. A second group of patients was treated with aligners made of a three-layer material (ABA, with 50% more elastomer than Zendura FLX), where layers A, B, and C were constructed of the same material as Zendura FLX. In this case, the phases were increased to 0.6 mm, 6 degrees, and a wear period of 14 days per aligner. This treatment is called Zendura Viva.

[0113] The tooth positions before and after treatment were compared and the predicted and achieved tooth movements and the difference were calculated. A total of 16 teeth were treated with the FLX system and a total of 17 teeth were treated with the Zendura Viva system, achieving comparable amounts of movement using 50% fewer aligners. Cases evaluated between the two treatments were selected to be comparable. Both translational and rotational movements were performed.

[0114] The following Table 10 shows the summary data for both treatments. Table 10:

[0115]

[0116] From this data it can be seen that the experimental treatment was at least as predictable while moving teeth with fewer aligners.

[0117] It should be understood that the constructions and properties shown in the drawings and embodiments are specific embodiments and are not intended to limit the scope of usable constructions and tests. According to alternative embodiments, other materials, constructions and step sequences may also be performed. For example, alternative embodiments may include additional layers, which include bonding layers, pigments, optical additives or reinforcing agents, and may be constructed in any manner known in the art, such as flat plate extrusion, coextrusion blown film, calendaring, lamination and adhesive bonding. In some embodiments, structures (or polymer sheets) and devices may be made by 3D printing or dip coating. Those of ordinary skill in the art will recognize and understand many variations, modifications and alternatives of the construction.

[0118] Additional embodiments, materials, material parameters and properties, methods of construction, definitions, etc. that may be used with embodiments herein may be found in U.S. Patent 10,549,511, U.S. Patent 10,946,630, U.S. Patent 10,870,263, and U.S. Patent 10,987,907, which are incorporated herein by reference for all purposes.

[0119] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0120] Unless otherwise specified herein or clearly contradicted by the context, the use of the terms "one (kind)", "one (kind)", "the / said" and "at least one (kind)" and similar indicators in the context of describing the disclosed subject matter (especially in the context of the following claims) should be interpreted as covering both the singular and the plural. Unless otherwise specified herein or clearly contradicted by the context, the use of a list of one or more items after the term "at least one (kind)" (e.g., "at least one (kind) of A and B") should be interpreted as an item selected from the listed items (A or B) or any combination of two or more items in the listed items (A and B). Unless otherwise specified, the terms "comprising", "having", "including" and "containing" should be interpreted as open terms (i.e., meaning "including but not limited to"). Unless otherwise specified herein, the description of the range of values ​​herein is intended only to be used as a shorthand method of citing each individual value falling within the range, and each individual value is incorporated into this specification as if it were individually quoted herein. Unless otherwise specified herein or clearly contradicted by the context, all methods described herein can be performed in any suitable order. Unless otherwise claimed, the use of any and all examples, or exemplary language (e.g., "for example") provided herein is intended only to better illustrate the disclosed subject matter and is not intended to limit the scope of the invention. No language in the specification should be construed as indicating that any non-claimed element is essential to the practice of the invention.

[0121] Certain embodiments are described herein. After reading the foregoing description, variations of those embodiments will be apparent to those of ordinary skill in the art. The inventors wish that such variations will be appropriately adopted by the skilled person, and the inventors wish to practice the embodiments in a manner different from that specifically described herein. Therefore, the present disclosure includes all modifications and equivalents of the subject matter described in the claims appended hereto as permitted by applicable law. In addition, unless otherwise stated herein or clearly contradictory to the context, the present disclosure encompasses any combination of all possible variations of the above elements.

Claims

1. A system for treating malocclusion, the system for moving one or more teeth from a first position to at least a second position according to a treatment plan, the system comprising: a series of one or more aligners, wherein at least one of the aligners comprises a multilayer structure having at least two outer layers and at least one elastomeric inner layer, wherein the thickness of the elastomeric inner layer is greater than 250 microns up to about 775 microns and the hardness is about Shore A80 to Shore D65, wherein at least one of the outer layers comprises a polymer having a modulus of from about 1,000 MPa to about 3,000 MPa as measured according to ASTM D638, wherein the combined thickness of the at least two outer layers and the at least one elastomeric inner layer is from about 500 microns to about 1,500 microns, and Wherein at least one of the aligners is configured such that when worn by the patient for a wearing time between 10 days and 15 days, at least one tooth of the patient exhibits an excursion movement of between about 0.35 mm and about 0.75 mm in the mesiodistal direction and / or the buccolingual direction, and / or at least one tooth of the patient exhibits a rotation of between about 3.5 degrees and about 7.5 degrees about the axis of the at least one tooth, and / or at least one tooth exhibits a mesiodistal tilting movement of between about 3.5 degrees and about 7 degrees.

2. The system of claim 1, wherein at least one of the aligners is configured such that when worn by the patient for the wearing time, two or more teeth of the patient each exhibit the offset movement between about 0.35 mm and about 0.75 mm.

3. The system of claim 1 , wherein at least one of the aligners is configured such that when worn by the patient for the wearing time, 8, 10, 12 or fewer teeth of the patient each exhibit the offset movement between about 0.35 mm and about 0.75 mm.

4. The system of claim 1, wherein the at least two outer layers each comprise a copolyester, a polycarbonate, a polyester polycarbonate blend, a polyurethane, a polyamide, or a polyolefin.

5. The system of claim 1 , wherein the at least one elastomeric inner layer comprises one or more of a polyurethane elastomer, a polyolefin elastomer, a polyester elastomer, a styrene elastomer, a polyamide elastomer, a cycloolefin elastomer, an acrylic elastomer, an aromatic or aliphatic polyether polyurethane, and a polyester polyurethane.

6. The system of claim 5, wherein the at least two outer layers each comprise a copolyester.

7. The system of claim 1, wherein the at least one elastomeric inner layer has a modulus of about 25 MPa to 500 MPa as measured according to ASTM D638.

8. The system of claim 1, wherein the at least one aligner further comprises one or more adhesive layers.

9. The system of claim 1, wherein the treatment plan is determined by reducing the number of treatment sessions in an initial treatment plan to a second plurality of treatment sessions including the series of two or more aligners, the initial treatment plan involving a first plurality of treatment sessions, each treatment session designed to effectuate an excursion movement of less than 0.3 mm to at least one tooth, wherein the number of treatment sessions in the first plurality of treatment sessions is greater than the number of treatment sessions in the second plurality of treatment sessions.

10. A system for treating malocclusion, the system being used to move one or more teeth from a first position to at least a second position according to a treatment plan, the system comprising: a series of two or more aligners, wherein each of the two or more aligners comprises a multilayer structure having at least two outer layers and at least one elastomeric inner layer, wherein the thickness of the elastomeric inner layer is greater than 250 microns up to about 775 microns and the hardness is about Shore A80 to Shore D65, wherein at least one of the outer layers comprises a polymer having a modulus of from about 1,000 MPa to about 3,000 MPa as measured according to ASTM D638, wherein the combined thickness of the at least two outer layers and the at least one elastomeric inner layer is from about 500 microns to about 1,500 microns, Wherein the two or more aligners are each configured such that when worn by the patient for a wearing time between 10 days and 15 days, at least one tooth of the patient exhibits an excursion movement of between about 0.35 mm and about 0.75 mm in the mesiodistal direction and / or the buccolingual direction, and / or at least one tooth of the patient exhibits a rotation of between about 3.5 degrees and about 7 degrees around the axis of the at least one tooth, and / or at least one tooth exhibits a mesiodistal tilting movement of between about 3.5 degrees and about 7 degrees.

11. The system of claim 10, wherein each of the two or more aligners is configured such that when worn by the patient for the wearing time, two or more teeth of the patient each exhibit the offset movement of between about 0.35 mm to about 0.75 mm.

12. The system of claim 10, wherein each of the two or more aligners is configured such that when worn by the patient for the wearing time, 8, 10, 12 or fewer teeth of the patient each exhibit the offset movement of between about 0.35 mm to about 0.75 mm.

13. The system of claim 10, wherein the at least two outer layers each comprise a copolyester, a polycarbonate, a polyester polycarbonate blend, a polyurethane, a polyamide, or a polyolefin.

14. The system of claim 10, wherein the at least one elastomeric inner layer of each of the two or more aligners comprises one or more of a polyurethane elastomer, a polyolefin elastomer, a polyester elastomer, a styrene elastomer, a polyamide elastomer, a cycloolefin elastomer, an acrylic elastomer, an aromatic or aliphatic polyether polyurethane, and a polyester polyurethane.

15. The system of claim 14, wherein the at least two outer layers of each of the two or more aligners comprise a copolyester.

16. The system of claim 10, wherein the at least one elastomeric inner layer of each of the two or more aligners has a modulus of about 25 MPa to 500 MPa as measured according to ASTM D638.

17. The system of claim 10, wherein each of the two or more aligners further comprises one or more adhesive layers.

18. The system of claim 10, wherein the treatment plan is determined by reducing the number of treatment sessions in an initial treatment plan to a second plurality of treatment sessions including the series of two or more aligners, the initial treatment plan involving a first plurality of treatment sessions, each treatment session designed to effectuate an excursion movement of less than 0.3 mm to at least one tooth, wherein the number of treatment sessions in the first plurality of treatment sessions is greater than the number of treatment sessions in the second plurality of treatment sessions.

19. A system for treating malocclusion, the system for moving one or more teeth according to a treatment plan comprising two or more stages, the system comprising: a series of one or more aligners, wherein at least one of the aligners comprises a multilayer structure having at least two outer layers and at least one elastomeric inner layer, wherein the thickness of the elastomeric inner layer is greater than 250 microns up to about 775 microns and the hardness is about Shore A80 to Shore D65, wherein at least one of the outer layers comprises a polymer having a modulus of from about 1,000 MPa to about 3,000 MPa as measured according to ASTM D638, wherein the combined thickness of the at least two outer layers and the at least one elastomeric inner layer is from about 500 microns to about 1,500 microns, and wherein at least one of the aligners is configured to effect one or more of an excursion movement of at least one tooth, a rotation of at least one tooth, and a mesiodistal tilting of at least one tooth in one treatment phase, wherein the excursion movement is between about 0.35 mm and about 0.75 mm in the mesiodistal direction and / or the buccolingual direction, wherein the rotation is between about 3.5 degrees and about 7.5 degrees about the tooth axis, and wherein the mesiodistal tilting movement is between about 3.5 degrees and about 7 degrees.

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