Dental device, material component, and improved treatment system

Abstract

An improved dental device and a polymer sheet composition are disclosed. The polymer sheet composition is useful for making a dental device having an outer layer composed of a material having a modulus of elasticity of about 1,000 MPa to 3,000 MPa (“hard”) and an inner core composed of an elastomeric material or a plurality of elastomeric materials having a modulus of elasticity of about 25 MPa to 500 MPa (“soft”) and a thickness greater than about 250 microns, which exhibit improved flexibility and strength, as well as better stain resistance and tear resistance, than currently available materials and dental devices.

Description

Technical Field

[0001] Cross - reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 354,998, filed on June 23, 2022, which is hereby incorporated by reference in its entirety for all purposes.

[0002]

[0002] This disclosure relates to systems and methods for sequentially moving teeth in orthodontic treatment, and more specifically, to combinations of treatment procedures with aligners and materials having specific properties combined to enhance tooth movement, which represents a significant advancement over the state of the art in clear aligner treatment.

Background Art

[0003]

[0003] Clear aligner treatment involves the application of a series of one or more plastic "aligner" shells that are customized to fit the teeth. Each shell is formed such that as the shell is displaced from one or more teeth, the shell applies a force to the one or more teeth to move the teeth toward a desired location different from their initial position. The shells can be designed to move teeth in different directions, such as horizontally, or rotationally, or buccally or lingually, or to cause intrusion or extrusion.

[0004]

[0004] The shell is typically composed of a plastic sheet heat - formed onto a dental model representing each of the planned stages or may be manufactured by 3D printing. The shell (commonly also called a positioner or aligner) may be a single - layer material, such as either a polyester copolymer or a polyurethane, or a multi - layer structure. Examples of single - layer structures include PETG materials such as Essix Ace (trademark) sold by Dentsply, and ridged polyurethanes such as Zendura (trademark) sold by Bay Materials, LLC. Examples of multi - layer materials include the SmartTrack (trademark) aligner sold by Align technology and Zendura FLX (trademark) sold by Bay Materials, LLC. Reference is made, for example, to U.S. Patent No. 9,655,691, U.S. Patent No. 9,655,693, U.S. Patent No. 10,549,511, U.S. Patent No. 10,946,630, U.S. Patent No. 10,870,263, and U.S. Patent No. 10,987,907, which are each incorporated by reference for all purposes. Other different multi - layer aligner materials are described in International Publication No. 2020 / 225651 and International Publication No. 2021025967, which are each incorporated by reference.

[0005]

[0005] In some cases, aligner treatment may involve using one or more types of materials, such as two - layer “hard / soft” materials (see, for example, orthoca, https: / / www.orthocaps.com / was - is - orthocaps / #sec1) and single - layer “hard” materials, or aligner treatment may use sequential devices having different thicknesses (e.g., 0.5 mm, 0.625 mm, 0.75 mm), such as the CA Aligner system promoted by Scheu - Dental (Germany).

[0006]

[0006] In clear aligner therapy, a treatment plan is typically prepared digitally, and a specific amount of movement is planned for each tooth at each step (which can include one or more teeth that do not move at all). General tooth movement includes simple translation (specified in mm per stage), rotation (specified in degrees per stage), and tipping movement (specified in degrees per stage), and can be buccal or lingual or mesial or distal or axial.

[0007]

[0007] Due to the stress / strain characteristics of prior art plastics such as polyester and rigid polyurethane and the biomechanics of tooth movement, the amount of tooth movement at each stage of current aligner therapy is limited to a maximum of about 0.3 mm. Attempts at greater movement typically cause discomfort to the patient, can damage the tooth roots or jawbone, and typically result in inaccurate movement. Further, it is well known that attempting to increase the tooth movement per stage can result in an ever-increasing delay in tooth movement. In the case of the "CA Aligner System", understanding that the actual movement is designed to be achieved over three sequential aligners, the effective movement per stage remains less than about 0.3 mm, so greater movement can be programmed.

SUMMARY OF THE INVENTION

[0008]

[0008] The present embodiment provides a treatment system for moving one or more teeth that preferably reduces the number of aligners required to complete orthodontic movement and preferably enables an extended range of movement without causing pain or damage to the tooth roots. The present embodiment preferably enables more predictable movement of teeth at each stage of aligner therapy. The present embodiment preferably enables the provision of an improved aligner and treatment plan that reduces the amount of material used to manufacture the device and / or shortens the time to manufacture the device.

[0009]

[0009] In some embodiments, the dental device is adapted to sequentially position one or more teeth using fewer stages than a previous aligner treatment plan. For example, various embodiments enable reducing the number of aligners for a treatment plan of treatment, determined, for example, by a dental provider or automatically using dental treatment planning software, by a factor of 1.25 to 1.5 or more times the tooth movement rate compared to previous systems.

[0010]

[0010] According to one embodiment, a system is provided for moving one or more teeth from a first location to at least a second location to treat malocclusion according to a treatment plan. The system includes a series of one or more aligners, at least one of the aligners being composed of a multi-layer structure having at least two outer layers and at least one elastomeric inner layer, the elastomeric inner layer having a thickness of more than 250 microns to a maximum of about 1,000 microns, such as about 300 microns to about 775 microns, and a hardness of about Shore A80 to Shore D65, at least one of the outer layers including a polymer having a modulus of elasticity of about 1,000 MPa to about 3,000 MPa, and the total thickness of the at least two outer layers and the at least one elastomeric inner layer being about 500 microns to about 1,500 microns. In one embodiment, when at least one of the aligners is worn by a patient over a wear time of 10 to 15 days, at least one tooth of the patient exhibits an offset movement in the mesial-distal direction and / or buccal-lingual direction of about 0.35 mm to about 0.75 mm, and / or at least one tooth of the patient exhibits a rotation of about 3.5 degrees to about 7.5 degrees about the axis of at least one tooth, and / or at least one tooth exhibits a movement of about 3.5 degrees to about 7 degrees of mesial-distal inclination movement and is configured and / or designed to do so.

[0011]

[0011] According to another embodiment, a system is provided for moving one or more teeth from a first location to at least a second location to treat malocclusion according to a treatment plan including two or more stages. The system includes a series of one or more aligners, at least one of the aligners being composed of a multi-layer structure having at least two outer layers and at least one elastomeric inner layer, the elastomeric inner layer having a thickness of more than 250 microns to a maximum of about 775 microns and a hardness of about Shore A80 to Shore D65, at least one of the outer layers including a polymer having an elastic modulus of about 1,000 MPa to about 3,000 MPa as measured according to ASTM D638, and the total thickness of the at least two outer layers and the at least one elastomeric inner layer being about 500 microns to about 1,500 microns. In one embodiment, at least one of the aligners is configured to effect one or more of an offset movement of at least one tooth, a rotation of at least one tooth, and a mesial-distal tipping movement of at least one tooth over the course of one treatment stage, the offset movement being in a mesial-distal direction and / or a buccal-lingual direction of about 0.35 mm to about 0.75 mm, the rotation being about 3.5 degrees to about 7.5 degrees about the axis of the tooth, and the movement of the mesial-distal tipping movement being about 3.5 degrees to about 7 degrees.

[0012]

[0012] In one embodiment, at least one of the aligners is configured such that when worn by a patient over a wearing period, each of two or more teeth of the patient exhibits an offset movement of about 0.35 mm to a maximum of about 0.75 mm.

[0013]

[0013] In one embodiment, at least one of the aligners is configured such that when worn by a patient over a wearing period, each of eight, ten, twelve, or fewer teeth of the patient exhibits an offset movement of about 0.35 mm to a maximum of about 0.75 mm.

[0014]

[0014] In one embodiment, each of at least two outer layers comprises a copolyester, a polycarbonate, a polyester polycarbonate blend, a polyurethane, a polyamide, or a polyolefin.

[0015]

[0015] In one embodiment, at least one elastomeric inner layer comprises one or more of a polyurethane elastomer, a polyolefin elastomer, a polyester elastomer, a styrenic elastomer, a polyamide elastomer, a cyclic olefin elastomer, an acrylic elastomer, an aromatic or aliphatic polyether polyurethane, and a polyester polyurethane.

[0016]

[0016] In one embodiment, each of at least two outer layers comprises a copolyester.

[0017]

[0017] In one embodiment, at least one elastomeric inner layer has a modulus of elasticity of about 25 MPa to 500 MPa, such as 25 MPa, or 50 MPa, or 100 MPa, or 250 MPa.

[0018]

[0018] In one embodiment, at least one aligner further comprises one or more bonding layers.

[0019]

[0019] According to another embodiment, a system is provided for moving one or more teeth from a first location to at least a second location in order to treat malocclusion according to a treatment plan, the system comprising a series of two or more aligners, each of the two or more aligners being composed of a multi-layer structure having at least two outer layers and at least one elastomeric inner layer, the elastomeric inner layer having a thickness of more than 250 microns to a maximum of about 1,000 microns, such as more than 300 to about 775 microns, and a hardness of about Shore A80 to Shore D65, at least one of the outer layers including a polymer having a modulus of elasticity of about 1,000 MPa to about 3,000 MPa, and the total thickness of the at least two outer layers and the at least one elastomeric inner layer being about 500 microns to about 1,500 microns. In one embodiment, when at least one of the aligners is worn by a patient over a wear time of 10 to 15 days, at least one tooth of the patient exhibits an offset movement in the mesial-distal direction and / or buccal-lingual direction of about 0.35 mm to about 0.75 mm, and / or at least one tooth of the patient exhibits a rotation of about 3.5 degrees to about 7 degrees about the axis of at least one tooth, and / or at least one tooth exhibits a movement of mesial-distal inclination movement of about 3.5 degrees to about 7 degrees, and is configured and / or designed accordingly.

[0020]

[0020] In one embodiment, each of the two or more aligners is configured such that when worn by a patient over a wear time, each of the two or more teeth of the patient exhibits an offset movement of about 0.35 mm to a maximum of about 0.75 mm.

[0021]

[0021] In one embodiment, each of the two or more aligners is configured such that when worn by a patient over a wear time, each of 8, 10, 12, or fewer teeth of the patient exhibits an offset movement of about 0.35 mm to a maximum of about 0.75 mm.

[0022]

[0022] In one embodiment, each of at least two outer layers comprises a copolyester, a polycarbonate, a polyester polycarbonate blend, a polyurethane, a polyamide, or a polyolefin.

[0023]

[0023] In one embodiment, at least one elastomeric inner layer of each of two or more aligners comprises one or more of a polyurethane elastomer, a polyolefin elastomer, a polyester elastomer, a styrenic elastomer, a polyamide elastomer, a cyclic olefin elastomer, an acrylic elastomer, an aromatic or aliphatic polyether polyurethane, and a polyester polyurethane.

[0024]

[0024] In one embodiment, at least two outer layers of each of two or more aligners each comprise a copolyester.

[0025]

[0025] In one embodiment, at least one elastomeric inner layer of each of two or more aligners has a modulus of elasticity of about 25 MPa to 500 MPa, such as 25 MPa, or 50 MPa, or 100 MPa, or 250 MPa, etc.

[0026]

[0026] In one embodiment, each of two or more aligners further comprises one or more bonding layers.

[0027]

[0027] In one embodiment, a treatment plan for a novel aligner treatment determines the number of treatment stages in an initial treatment plan with a first plurality of treatment stages designed to effect an offset movement of at least one tooth each less than 0.3 mm by reducing it to a second plurality of treatment stages including a series of two or more aligners, and the number of treatment stages in the first plurality of treatment stages is greater than the number of treatment stages in the second plurality of treatment stages.

[0028] Other features and advantages of the present invention will be understood with reference to the remaining portions of this specification, including the drawings and the claims. Further features and advantages of the present invention, as well as the structure and operation of various embodiments of the present invention, will be described in detail below with reference to the accompanying drawings. In the drawings, like reference numerals indicate identical or functionally similar elements.

[0029]

[0029] The detailed description is made with reference to the accompanying drawings. The use of the same reference numerals in different examples in the description and the drawings may indicate similar or identical items.

Brief Description of the Drawings

[0030]

Figure 1A

Figure 1B

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

DETAILED DESCRIPTION OF THE INVENTION

[0031]

[0040] The present disclosure relates to materials, systems, and methods for moving teeth using one or more clear aligners comprising an aligner having three or more layers including at least two rigid outer materials and an inner elastomeric material, and to staged movement of one or more teeth of about 0.35 mm to 0.8 mm per stage and / or rotation of about 3.5 degrees to 8 degrees. For example, in one embodiment, at least one aligner of a set of aligners provides a tooth movement rate of at least one tooth of more than 0.35 mm in 10 days or more than 0.35 mm in 14 days when consistently worn by a patient or user during that period. The movement may be in the mesial / distal direction and / or the buccal / lingual direction.

[0032]

[0041] Furthermore, in one embodiment, at least one aligner of the set of aligners provides a tooth rotation speed of at least one tooth about the axis of that tooth (e.g., the long axis) of more than 0.35 degrees in 10 days or more than 3.5 degrees in 14 days when consistently worn by a patient or user during that period. Further, in one embodiment, at least one aligner of the set of aligners provides a tooth translation speed of at least one tooth about the center of resistance of that tooth of more than 0.35 degrees in 10 days or more than 3.5 degrees in 14 days when consistently worn (e.g., at least 18 hours per day) by a patient or user during that period.

[0033]

[0042] Figure 1A is a schematic cross-sectional view of a three-layer sheet having a simple ABC configuration. Layers A and C may be the same or different materials, and each layer may be composed of one or more materials, or a blend or alloy. Layer B may be a single material, a blend of materials, or an alloy.

[0034]

[0043] Figure 1B is a schematic cross-sectional view of a multilayer sheet. Each of layers A, B, and C may be composed of a single layer or multiple layers, and each layer may be composed of one or more materials or a blend of materials. As illustrated in Figure 1B, layer A may be composed of two or more layers, such as layer a and layer a', layer B may be composed of two or more layers, such as layer b and layer b', and layer C may be composed of two or more layers, such as layer c and layer c'.

[0035]

[0044] The three-layer sheet of Figure 1A and the multilayer sheet of Figure 1B can be used to form dental devices, such as aligners, according to various embodiments of the present specification.

[0036]

[0045] In one embodiment, a composition is provided that is composed of at least two outer layers A and C and an intermediate layer B. The A and C layers each contain a polymer having a modulus of elasticity 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, such as a thermoplastic polymer. The intermediate B layer is composed of at least an elastomer having a modulus of elasticity 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.

[0037]

[0046] In one embodiment, the A and C layers are composed of one or more of copolyesters, polycarbonates, polyester polycarbonate blends, polyurethanes, polyamides, or polyolefins.

[0038]

[0047] In one embodiment, the intermediate B layer is composed of one or more of polyurethane elastomers, polyolefin elastomers, polyester elastomers, styrenic elastomers, polyamide elastomers, cyclic olefin elastomers, acrylic elastomers, aromatic or aliphatic polyether polyurethanes, or polyester polyurethanes, or polycarbonate polyurethanes.

[0039]

[0048] In one embodiment, the aligner has a tensile modulus of elasticity of about 600 to about 1,000 MPa and a flexural modulus of elasticity of about 1,100 to about 1,400 MPA.

[0040]

[0049] In one embodiment, the aligner may include five or more layers including two or more elastomer layers (see, for example, FIG. 1B). In one embodiment, the total thickness of the elastomeric material is about 450 or 500 microns to 1,000 microns or more, or 650 to 1,000 microns, or 750 to 1,000 microns.

[0041]

[0050] In one embodiment, one or more teeth may be programmed or staged to move during any one stage. For example, in one embodiment, more than three but less than ten teeth may be programmed or staged to move more than 0.35 mm or more than 0.4 mm per stage. In one embodiment, the maximum movement should be about 7.5 mm or less or 8.0 mm or less per stage. The individual or cumulative movement of the teeth can be in the mesial / distal direction and / or the buccal / lingual direction.

[0042]

[0051] Tables 1 and 2 are charts showing examples of movement (Table 2) based on an example of an aligner material design (Table 1) in which the A layer and the C layer are outer layers and the B layer is an inner layer or an intermediate layer.

Table 1

Table 2

[0043]

[0052] In one embodiment, one or more teeth may be programmed or staged to rotate and / or tilt during any one stage. For example, in one embodiment, more than three but less than ten teeth may be programmed or staged to rotate or tilt more than 3.5 degrees or more than 4 degrees per stage. In one embodiment, the rotation or angular tilt movement should be such that the movement is about 7.5 degrees or less or 8.0 degrees or less per stage.

[0044]

[0053] In one embodiment, one or more teeth may be programmed or staged to move axially (e.g., protrusion movement or depression movement) during any one stage. For example, in one embodiment, more than three but less than ten teeth may be programmed or staged to move more than 0.3 mm or more than 0.4 mm per stage.

[0045]

[0054] To determine the tooth stage, treatment planning software executed on a computer system may be used. The automated treatment planning software obtains the initial tooth location and the final tooth location and establishes the difference therebetween, for example, a difference of 1 mm or 10 mm. Thereafter, the software may be given "the maximum movement per stage limit, for example 0.3 mm". The software then generates an intermittent stage (case plan) for moving the tooth to that location and orientation. Preferably, embodiments of the present disclosure are particularly useful for users who may desire a more adjusted plan involving a wider range of tooth movement. Embodiments herein provide an expansion of both the linear and angular ranges of tooth movement per stage of Invisalign treatment and improved control of the number of stages (e.g., in some cases, a reduced set of stages) to bring about the desired result (final tooth location and orientation), compared to previous Invisalign treatment plans. For example, using the higher elastic layer structure described herein, tooth movement can be 1.5 times or 2.0 times faster with respect to the tooth speed.

[0046]

[0055] In one embodiment, the total thickness of the A layer, B layer, and C layer is from about 250 microns to about 2,000 microns, or from about 500 microns to about 1500 microns.

[0047]

[0056] In one embodiment, the intermediate B layer comprises an aromatic polyether polyurethane having a Shore hardness of about A90 - D55, about A85 - D60, or about A80 - D65 and a compression set of less than 35%, and the interlayer peel strength between the A layer and the C layer and the B layer is greater than 50 N per 2.5 cm. The term "peel strength" can be measured in accordance with ASTM D3163. The specifications of the useful material Trilaminate PN 9210 Extrusion-Lamination&Slit Rolls are interlayer bonding, ASTM D3163, peel force > 50 N, 2.54 cm. The term "compression set" is used herein with respect to the permanent strain of a material when a force is applied and removed. Unless otherwise specified, compression set is measured in accordance with ASTM D395-B (ISO 815) at the specified time and at a temperature of 23 °C for 22 hours.

[0048]

[0057] FIG. 2 shows the modulus of elasticity and flexural modulus of five different aligner materials, as also shown in Table 3 below.

Table 3

[0049]

[0058] In one embodiment, one or more dental devices are provided that are each conformal to one or more teeth and made from the compositions or polymer sheets described herein.

[0050]

[0059] In one embodiment of the dental device, the total thickness of the A, B, and C layers is from about 300 microns to about 1,500 microns, and the total thickness of the A and C layers is 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 the B layer is from about 250 microns to about 1000 microns.

[0051]

[0060] In one embodiment, the elastomeric intermediate layer comprises a polyurethane or polyester elastomer having a hardness of about A80 - D75, A85 - D65, or A90 - D55, such as A95, A90, A85, A80, A75, D50, D55, D60, D65, or D70.

[0052]

[0061] In another embodiment, there is provided a composition, polymer sheet, or dental device having environmental stress resistance and composed of at least two outer layers and an elastomeric inner layer, wherein one or more of the outer layers is a polyester or copolyester having a modulus of elasticity of about 1,000 MPa - 3,000 MPa, the inner layer comprises an elastomer having a modulus of elasticity of about 25 MPa - about 500 MPa, and the interlayer peel strength between at least one outer layer and the elastomer is greater than about 50 N / inch.

[0053]

[0062] In another aspect, there is provided a reversibly deformable dental device, wherein the thickness of the outer A layer is about 100 microns - about 250 microns, such as 100 microns, 125 microns, 150 microns, 175 microns, 200 microns, 225 microns, or 250 microns, the thickness of the outer C layer is about 100 microns - about 250 microns, such as 100 microns, 125 microns, 150 microns, 175 microns, 200 microns, 225 microns, or 250 microns, the thickness of the intermediate B layer is greater than about 250 microns, such as 300 - 1000 microns, and the total thickness of the A layer, B layer, and C layer is 450 - 1,500 microns or more.

[0054]

[0063] In some embodiments, to improve the adhesion of polymer layers that are not naturally adhesive to each other, a thin layer of an additional polymer (bonding layer) may be present, for example, using a layer of maleic anhydride grafted polypropylene to enhance the adhesion between a polypropylene A layer and a polyester or polyamide B layer. Other bonding materials may include copolymers of ethylene and acrylic esters, and / or ethylene-co-acrylic acid containing vinyl acetate, ethylene grafted maleic anhydride, and optionally other alpha olefins.

[0055]

[0064] In some embodiments, a set of one or more dental devices may be formed by thermoforming a multilayer sheet over a dental model, and the thermoforming is performed at a temperature higher than at least the glass transition temperature and / or melting point of the outer layer and at least above the glass transition temperature and / or melting point of the inner layer material, such as an elastomeric material.

[0056]

[0065] It should be understood that elements of two or more embodiments may be combined.

[0057]

[0066] In some embodiments, the dental device is adapted to sequentially position one or more teeth using fewer stages than a previous aligner treatment plan, at least in part due to an increase in elasticity as a result of the combination of layer thickness and hardness characteristics.

[0058]

[0067] When one hard outer layer is thinner than another hard outer layer, thermoforming the thinner hard layer against the model provides improved contact and conformity with the model, enhancing comfort, fit, and mechanical force coupling.

[0059]

[0068] In some embodiments, the hard outer layer that contacts the teeth on the inside of the device has a thickness that is thinner (e.g., asymmetric) than another hard layer.

[0060]

[0069] In some embodiments, the thickness of the hard layer that contacts the teeth can be less than about 250 microns or about 50 microns thin.

[0061]

[0070] In certain embodiments, the multi-layer sheet may be prepared by several means including, but not limited to, hot or cold lamination, adhesive lamination, melt lamination, co-extrusion, multi-layer extrusion, or other known methods. The sheet may be fully prepared before forming into an orthodontic device, or the device may be prepared using a series of individual thermoforming steps to create the multi-layer.

[0062]

[0071] Thermoforming of the sheet to produce test samples or dental devices can be carried out using procedures commonly used in the industry, using a "Biostar" pressure former available from Great Lakes Orthodontics. Alternatively, thermoforming may be carried out using a roll-fed thermoformer, a vacuum former, or other known thermoforming techniques. Different conditions, forms, or models may be used to vary the draw ratio and part thickness. Multi-layer devices can be manufactured by one or more 3D printing processes, or by known similar processes for producing sequential dip coatings, spray coatings, powder coatings, or films, sheets, and 3D structures.

[0063] Definitions

[0072] The term "dental device" is used herein with respect to any device placed in or on the teeth of interest. Dental devices include, but are not limited to, orthodontic devices, prosthetic devices, retention devices, snoring / airway devices, cosmetic devices, therapeutic devices, protective devices (e.g., mouth guards), and habit modification devices. An example of a dental device is an aligner, such as a clear aligner.

[0064]

[0073] The term "flexural modulus" is used herein with respect to the stiffness of a material and / or the resistance of the material to flexural deformation. The higher the flexural modulus of a material, the higher the resistance to bending. In the case of an isotropic material, the modulus of elasticity measured in any direction is the same.

[0065]

[0074] The term "hardness" is used herein with respect to the Shore hardness scale and, unless otherwise specified, is measured in accordance with ASTM D 2240. A durometer measures the penetration of a metal foot or pin 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 compared to a material with a lower durometer value. Shore hardness and modulus of elasticity generally correlate and can be converted by approximation if only one value is known by methods described in the art.

[0066]

[0075] The expressions "modulus of elasticity", "Young's modulus", and "elastic coefficient" are used herein with respect to the stiffness of a material and / or the resistance of the material to elongation. The higher the modulus of elasticity of a material, the higher the stiffness. The flexural modulus and elastic coefficient of a material may be the same or different. In the case of isotropic materials such as A, B, and C, the flexural modulus and modulus of elasticity (sometimes referred to as the elastic coefficient) of a component are substantially the same and either one or the other may be measured depending on the situation. In the case of a laminated structure, the elastic coefficient and flexural modulus may be significantly different. In the case of a polymer, mechanical properties including the elastic coefficient and other properties can be measured as prohibited by ASTM D 638. The flexural modulus can be measured by the tests listed in ASTM D790 and uses units of force per area. Unless otherwise specified, "modulus of elasticity" refers to the elastic coefficient.

[0067]

[0076] The term "polymer sheet" is used interchangeably herein with the term "plastic sheet".

[0068]

[0077] As used herein with respect to numerical values, the term "about" means that the value can be within a small percentage (e.g., 10% or less) of the value, e.g., within 10% or 5% or 2%, and for example, "about 50" can include 45 to 55, and about 3000 can include 2700 to 3300.

[0069]

[0078] As used herein, the term "shell" refers to a polymeric structure that fits over a tooth and is removably disposed thereon.

[0070]

[0079] As used herein with respect to polymers, the term "thermoplastic polymer" is a polymer that becomes flexible or moldable above a specific temperature and solidifies upon cooling, provided that heat and pressure do not chemically decompose the polymer.

[0071]

[0080] The terms "tooth" and "teeth" include natural teeth, including natural teeth modified by fillings or crowns, implanted teeth, artificial teeth that are part of a bridge or other fitting fixed to one or more natural or implanted teeth, and artificial teeth that are part of a removable fitting.

[0072]

[0081] As used herein, the term "stage" is used to mean one or more steps in a treatment plan, and each "stage" is represented by an aligner. The treatment plan may include one or more stages, e.g., 10 stages, and each stage is a proposed tooth movement converted into an aligner. The wear duration of a "stage" refers to the length of time a patient wears a particular set (one or two) of aligners, e.g., 5 days, 7 days, 10 days, or 15 days in length. Multiple stages are typically combined to provide for execution of elongation and / or movement of multiple teeth, rotation, etc.

[0073] Examples

[0082] Table 4 below shows an example of possible linear and angular movements depending on the dimensions of the elastic inner layer B.

Table 4

[0074] Table 5 below shows an example of possible stage reduction according to the embodiment.

Table 5

[0075]

[0083] Figure 3 shows an example of a treatment plan according to the embodiment of the present specification, which is formed using the materials of the present disclosure and is applied to a patient who initially had 6 upper aligners and 4 lower aligners planned, including only 3 upper aligners and 2 lower aligners (the number of stages was reduced by 50%). The superimposed positions before and after treatment are also shown from two different angles. The patient did not complain of discomfort during treatment. Figure 4 and Tables 6 and 7 below show an overview of the tooth movement for the patient treatment plan of Figure 3. The movement includes straightening of the upper anterior teeth (-ive, Trq, +ive buccal movement), improvement in the vertical position of the upper teeth (extrusion), and improvement in the movement of the tipping movement (mesiodistal angulation).

Table 6

Table 7

[0076]

[0084] Figure 5 shows an example of a retreatment plan according to the embodiment of the present specification, which includes the use of one aligner for a conventional two-stage treatment plan. The single aligner was formed using the materials of the present disclosure. The superimposed positions before and after treatment are also shown. The patient did not complain of discomfort during treatment. Figure 6 and Table 8 below show an overview of the tooth movement for the patient treatment plan of Figure 5.

Table 8

[0077]

[0085] Figure 7 shows an example of a retreatment plan according to an embodiment of the present specification, including two aligners for a conventional six-stage treatment plan. The aligner stages were formed using the materials of the present disclosure. The patient did not complain of discomfort during treatment. Figures 8 and Table 9 below show an overview of the tooth movement of the patient treatment plan in Figure 7. [Table 9]

[0078]

[0086] Example:

[0079]

[0087] The materials and treatment plans according to the embodiments of the present specification were used when evaluating tooth movement. A group of patients was treated in this specification with aligners made using a prior art material (Zendura FLX, available from Bay Materials, LLC, Fremont, California), herein referred to as the following FLX treatment, and a typical aligner stage plan of a wear cycle of 0.3 mm / 3 degrees and 14 days per aligner. A second group of patients was treated with aligners made from a three-layer material (ABA having 50% more elastomer than Zendura FLX) of one embodiment, where the A layer, B layer, and C layer were composed of the same material as Zendura FLX. In this case, the stage increased to a wear cycle of 0.6 mm, 6 degrees, and 14 days per aligner. This treatment is called Zendura Viva.

[0080]

[0088] The tooth positions before and after treatment were compared, and the predicted tooth movement amount, the achieved tooth movement amount, and the difference therebetween 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 using 50% fewer aligners with equivalent movement amounts. The cases evaluated between the two treatments were selected to be equivalent. Both translational movement and rotational movement were performed.

[0081]

[0089] The following Table 10 shows the summarized data for the two treatments. Table 10: [Table 10]

[0082]

[0090] From this data, it can be seen that experimental treatment is at least predictable while moving teeth with less aligner.

[0083]

[0091] It should be understood that the configurations and characteristics shown in the figures and examples are specific examples and are not intended to limit the scope of the configurations and tests that can be used. Other materials, configurations, and series of steps may be performed according to alternative embodiments. For example, alternative embodiments may include additional layers including a bonding layer, pigment, optical additive, or reinforcing agent, and may be constructed by any method known in the art such as flat sheet extrusion, coextrusion inflation film, calendering, lamination, and adhesive bonding. The structure (or polymer sheet) and device may, in some embodiments, be made by 3D printing or dip coating. Those skilled in the art will recognize and understand many variations, modifications, and alternatives of the configuration.

[0084]

[0092] Additional embodiments, materials, material parameters, and characteristics, methods of construction, definitions, etc. useful in the embodiments of this specification can be found in U.S. Patent No. 10,549,511, U.S. Patent No. 10,946,630, U.S. Patent No. 10,870,263, and U.S. Patent No. 10,987,907, all of which are hereby incorporated by reference in their entirety for all purposes.

[0085]

[0093] All references, including publications, patent applications, and patents cited herein, are hereby incorporated by reference to the extent that each reference is individually and specifically indicated to be incorporated by reference and as fully as if it were set forth in its entirety herein.

[0086]

[0094] In the context of describing the disclosed subject matter, particularly in the context of the following claims, the use of the terms "a," "an," "the," "at least one," and similar designations should be construed to include both the singular and the plural unless otherwise indicated herein or clearly contradicted by the context. The use of the term "at least one" following a listing of one or more items (e.g., "at least one of A and B") should be construed to mean either one of the listed items (A or B) or any combination of two or more of the listed items (A and B) unless otherwise indicated herein or clearly contradicted by the context. The terms "comprising," "having," "including," and "containing" should be construed as open-ended terms (i.e., meaning "including, but not limited to") unless otherwise noted. The recitation of a range of values herein is merely intended to serve as a convenient method of referring individually to each separate value falling within the range, and each separate value is incorporated herein as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or clearly contradicted by the context. The use of any examples, or exemplary language (e.g., "such as") provided herein is merely intended to make the disclosed subject matter more clear and is not intended to limit the scope of the invention unless otherwise claimed. No language in this specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0087]

[0095] Specific embodiments are described herein. Variations of these embodiments may become apparent to those skilled in the art upon reading the foregoing description. The inventors expect those skilled in the art to appropriately employ such variations, and the inventors intend for the embodiments to be practiced otherwise than as specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Further, any combination of any possible variations of the above-described elements is included in this disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.

Claims

1. A system for moving one or more teeth from a first location to at least a second location in order to treat malocclusion according to a treatment plan, the system comprising: a series of one or more aligners, at least one of the aligners being composed of a multilayer structure having at least two outer layers and at least one elastomeric inner layer; the elastomeric inner layer having a thickness greater than 250 microns to a maximum of about 775 microns and a hardness of about Shore A80 to Shore D65; at least one of the outer layers comprising a polymer having a modulus of elasticity of about 1,000 MPa to about 3,000 MPa as measured according to ASTM D638; the total thickness of the at least two outer layers and the at least one elastomeric inner layer being about 500 microns to about 1,500 microns; at least one of the aligners being configured such that when worn by a patient over a wear time of 10 days to 15 days, at least one tooth of the patient exhibits an offset movement in the mesial-distal direction and / or buccal-lingual direction of about 0.35 mm to about 0.75 mm, and / or at least one tooth of the patient exhibits a rotation of about 3.5 degrees to about 7.5 degrees about the axis of the at least one tooth, and / or at least one tooth exhibits a movement of a mesial-distal inclination movement of about 3.5 degrees to about 7 degrees; System.

2. The system according to claim 1, wherein at least one of the aligners is configured such that when worn by the patient over the wear time, two or more teeth of the patient each exhibit the offset movement of about 0.35 mm to a maximum of about 0.75 mm.

3. The system according to claim 1, wherein at least one of the aligners is configured such that when worn by the patient over the wear time, 8, 10, 12, or fewer teeth of the patient each exhibit the offset movement of about 0.35 mm to a maximum of about 0.75 mm.

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

5. The system according to 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 styrenic elastomer, a polyamide elastomer, a cyclic olefin elastomer, an acrylic elastomer, an aromatic or aliphatic polyether polyurethane, and a polyester polyurethane.

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

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

8. The system according to claim 1, wherein at least one aligner further comprises one or more bonding layers.

9. The number of treatment stages in an initial treatment plan with a first plurality of treatment stages designed to effect an offset movement of at least one tooth, each less than 0.3 mm, is reduced to a second plurality of treatment stages including a series of two or more aligners, and the number of treatment stages in the first plurality of treatment stages is greater than the number of treatment stages in the second plurality of treatment stages, the system according to claim 1.

10. A system for moving one or more teeth from a first location to at least a second location to treat malocclusion according to a treatment plan, the system comprising: a series of two or more aligners, each of the two or more aligners being composed of a multilayer structure having at least two outer layers and at least one elastomeric inner layer; the elastomeric inner layer having a thickness of greater than 250 microns to a maximum of about 775 microns and a hardness of about Shore A80 to Shore D65; at least one of the outer layers comprising a polymer having a modulus of elasticity of about 1,000 MPa to about 3,000 MPa as measured according to ASTM D638; the total thickness of the at least two outer layers and the at least one elastomeric inner layer being about 500 microns to about 1,500 microns. When the two or more aligners are worn by a patient for a wearing time of 10 days to 15 days, at least one tooth of the patient exhibits an offset movement in the mesial-distal direction and / or buccal-lingual direction of about 0.35 mm to about 0.75 mm, and / or at least one tooth of the patient exhibits a rotation of about 3.5 degrees to about 7 degrees about the axis of the at least one tooth, and / or the at least one tooth exhibits a movement of about 3.5 degrees to about 7 degrees of mesial-distal inclination movement, System. **Claim 11** The system according to claim 10, wherein each of the two or more aligners is configured such that when worn by the patient over the wearing time, two or more teeth of the patient each exhibit the offset movement of about 0.35 mm to a maximum of about 0.75 mm. **Claim 12** The system according to claim 10, wherein each of the two or more aligners is configured such that when worn by the patient over the wearing time, eight, ten, twelve, or fewer teeth of the patient each exhibit the offset movement of about 0.35 mm to a maximum of about 0.75 mm. **Claim 13** The system according to claim 10, wherein each of the at least two outer layers comprises a copolyester, polycarbonate, polyester polycarbonate blend, polyurethane, polyamide, or polyolefin. **Claim 14** The system according to 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, polyolefin elastomer, polyester elastomer, styrenic elastomer, polyamide elastomer, cyclic olefin elastomer, acrylic elastomer, aromatic or aliphatic polyether polyurethane, and polyester polyurethane. **Claim 15** The system according to claim 14, wherein each of the at least two outer layers of each of the two or more aligners comprises a copolyester. **Claim 16** The system according to claim 10, wherein the at least one elastomeric inner layer of each of the two or more aligners has an elastic modulus of about 25 MPa to 500 MPa as measured according to ASTM D638. **Claim 17** The system according to claim 10, wherein each of the two or more aligners further comprises one or more bonding layers. **Claim 18** The number of treatment stages in an initial treatment plan with a first plurality of treatment stages designed such that each results in an offset movement of at least one tooth of less than 0.3 mm is determined by reducing it to a second plurality of treatment stages including a series of two or more aligners, wherein the number of treatment stages in the first plurality of treatment stages is greater than the number of treatment stages in the second plurality of treatment stages. The system according to claim 10.

19. A system for moving one or more teeth to treat malocclusion according to a treatment plan including two or more stages, the system comprising A series of one or more aligners, at least one of the aligners being composed of a multi-layer structure having at least two outer layers and at least one elastomeric inner layer, The elastomeric inner layer has a thickness of more than 250 microns to a maximum of about 775 microns and a hardness of about Shore A80 to Shore D65, At least one of the outer layers includes a polymer having an elastic modulus of about 1,000 MPa to about 3,000 MPa as measured according to ASTM D638, 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, At least one of the aligners is configured to effect, over one treatment stage, one or more of an offset movement of at least one tooth, a rotation of the at least one tooth, and a mesial-distal tipping movement of the at least one tooth, the offset movement being in the mesial-distal direction and / or the buccal-lingual direction of about 0.35 mm to about 0.75 mm, the rotation being about 3.5 degrees to about 7.5 degrees about the axis of the tooth, and the movement of the mesial-distal tipping movement being about 3.5 degrees to about 7 degrees. System.

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