Dental brace

Abstract

The present invention provides one or more dental braces that can be better tuned to deliver specific and more stable (lower creep) forces on the teeth while also being softer and thinner. The orthodontic appliance also provides greater control right for doctors, and the treatment can be customized according to the treatment stage, careful requirements and pain tolerance of the patient.

Description

Technical Field

[0001] The present invention relates to one or more dental braces that can be adjusted to deliver specific and more stable (lower creep) forces on the teeth while also being softer and thinner. The present dental braces also provide the physician with greater control to tailor treatment to the patient's stage of treatment, prudent requirements, and pain tolerance.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application No. 63 / 064,158, filed on August 11, 2020, the contents of which are incorporated herein in their entirety. Background Art

[0004] Many people need their teeth straightened. Braces have been used to straighten or move teeth. Braces are connected by wires. Aligners, on the other hand, are a series of tight-fitting, custom-made mouthpieces that span the teeth. Invisalign is the largest producer of clear aligners, but it's not the only brand. Other brands include Clear Correct, Inman Aligner, and Smart Moves.

[0005] Wearing currently available plastic dental braces (such as Invisalign TM ) can be painful and uncomfortable for patients during the first few hours or days of orthodontic braces. These braces are designed to exert relatively high levels of force on the teeth—hence the braces are typically stiff and thick, which also makes their installation in the teeth difficult and painful. Patients experience this initial pain and discomfort many times during their orthodontic treatment, as these procedures involve the use of multiple braces in succession—for example, 20 braces over a 6-month period. In addition, discomfort and pain prompt many patients to remove their braces more frequently, which can add weeks or months to treatment time. If one corrective step does not fully advance the patient to the next step in their sequence, a costly intervention called “mid-course correction” is required to continue the prescribed orthodontic treatment.

[0006] Discomfort, pain, and inefficiency are due to the plastic construction used in current braces. These typically rely on rigid plastics to provide the physical properties (primarily force) required for effective correction. Conventional plastic construction also produces suboptimal creep forces - the force applied by the braces drops very quickly due to early creep of the polymer after installation, especially within the first 24 hours. This creep reduces the effective force that can be used to move teeth through the rest of the retainer sequence. Therefore, each retainer must be designed more aggressively to compensate for the loss of force due to creep and still effectively move teeth. The materials used in these braces offer limited force and creep design control. For patients, this results in increased pain and discomfort (especially in the first hour or so of use), and it often leads to the need for multiple visits to the dentist.

[0007] In view of the above limitations, there is an unmet need for dental braces that address the shortcomings of existing dental braces. In view of the above needs, the present invention provides one or more dental braces that can be better adjusted to transmit specific and more stable (lower creep) forces on the teeth, while also being softer and thinner. Such braces will create a better experience for patients and provide physicians with greater control to customize treatment based on the patient's treatment stage, care requirements, and pain tolerance. Using a retainer structure with adjustable force and creep curves can create a treatment process that can result in better compliance, less mid-range correction, less pain, and ultimately better treatment results. Summary of the invention

[0008] In one embodiment, the present invention provides a dental brace comprising a component made of a plastic material having a Rockwell R hardness greater than about 50 and less than about 130, wherein the component is selected from polyethylene terephthalate glycol (PETG), rigid thermoplastic polyurethane (r-TPU), polysulfone, and combinations thereof.

[0009] In another embodiment, the present invention provides a dental brace comprising an outer layer and an inner component, wherein the outer layer is soft and comprises a polymer with a Shore hardness of about 50A to about 60D, which is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic co-poly (ether or ester-ester), elastic co-poly (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof; the inner component is harder than the outer layer and is composed of a plastic material with a Rockwell R hardness greater than about 60 and less than about 115, wherein the plastic material is selected from polyethylene terephthalate glycol (PETG), rigid thermoplastic polyurethane (r-TPU), polysulfone, and combinations thereof.

[0010] Another aspect of the present invention provides a dental brace comprising a multilayer material selected from a core layer or inner layer, and a surface layer or outer layer, wherein the core layer has a hard component made of a plastic material with a Rockwell R hardness greater than about 60 and less than about 115, which is selected from polyethylene terephthalate glycol (PETG), rigid thermoplastic polyurethane (r-TPU), polysulfone, and combinations thereof; the surface layer comprises a soft polymer with a Shore hardness of about 50A to about 60D, which is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copolymer (ether or ester-ester), elastic copolymer (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof.

[0011] Another aspect of the present invention provides a dental brace comprising an outer layer and an inner layer, wherein the outer layer is hard and comprises a thermoplastic material having a Rockwell R hardness greater than about 60 and less than about 110, wherein the thermoplastic material is selected from the family of homopolymers and copolymers of polysulfone and their blends; the inner layer close to the teeth is softer than the outer layer and is composed of a thermoplastic material having a Shore hardness of about 50A to about 60D, and the thermoplastic material is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copolymer (ether or ester-ester), elastic copolymer (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof.

[0012] Another aspect of the present invention provides a dental brace comprising a multilayer material selected from a core layer or inner layer, and a surface layer or outer layer, wherein the core layer has a rigid thermoplastic material having a Rockwell R hardness greater than about 60 and less than about 110, wherein the thermoplastic material is selected from the family of homopolymers and copolymers of polysulfone and their blends; the surface layer comprises a soft thermoplastic polymer having a Shore hardness of about 50A to about 60D, and the thermoplastic material is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastomeric copolymer (ether or ester-ester), elastomeric copolymer (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof.

[0013] In one embodiment, the present invention provides a dental brace comprising a component made of a plastic material having a Shore hardness greater than about 55D and less than about R100, wherein the component is selected from polyethylene terephthalate glycol (PETG), rigid thermoplastic polyurethane (r-TPU), polysulfone, and combinations thereof. A preferred embodiment provides a dental brace having a total thickness of about 15 mils to about 20 mils.

[0014] Another preferred embodiment provides a dental appliance wherein the modulus of the dental appliance is in the range of about 200,000 psi but less than about 500,000 psi and the initial force applied is in the range of about 120 lbs to about 300 lbs.

[0015] Another embodiment of this aspect of the invention provides a dental brace wherein an active ingredient and / or therapeutic composition is incorporated into the plastic material, selected from an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances one or more dental treatments. A preferred embodiment of this aspect provides a dental brace wherein the plastic material releases the active ingredient and / or therapeutic composition, such as an analgesic, an antibacterial, a tooth whitening agent, or other agent that enhances one or more dental treatments, over a period of time.

[0016] Another aspect of the present invention provides a dental brace comprising an outer layer and an inner component, wherein the outer layer is soft and comprises a polymer having a Shore hardness component of about 50A to about 50D, which is selected from TPU, TPE, elastic copolyester, TPV, EMA, EBA, and combinations thereof; the inner component is harder than the outer layer and is composed of a plastic material having a Shore hardness component greater than about 50D and less than about R100, wherein the plastic material is selected from polyethylene terephthalate glycol (PETG), polysulfone, thermoplastic polyurethane (TPU), and combinations thereof.

[0017] A preferred embodiment of this aspect of the invention provides the dental brace of claim 4, wherein the outer soft layer accounts for about 10% to about 20% of the total thickness of the dental brace. In another preferred embodiment, a dental brace of claim 5 is provided, wherein the outer soft layer accounts for about 5% to about 15% of the total thickness of the dental brace.

[0018] Another preferred embodiment provides a dental appliance wherein the dental appliance has a modulus of about 200,000 psi and less than about 500,000 psi and an initial force applied of about 120 lbs and less than about 300 lbs.

[0019] Another embodiment of this aspect of the invention provides a dental brace, wherein an active ingredient and / or therapeutic composition is added to the outer soft layer, which is selected from an analgesic, an antibacterial agent, a tooth whitening agent, and an agent that enhances one or more dental treatments. A preferred embodiment of this aspect provides a dental brace, wherein the outer soft layer releases the active ingredient and / or therapeutic composition, such as an analgesic, an antibacterial agent, a tooth whitening agent, or other agents that enhance one or more dental treatments over a period of time.

[0020] Another aspect of the present invention provides a dental brace comprising a multilayer material selected from a core layer or inner layer, and a surface layer or outer layer, wherein the core layer comprises a hard component made of a plastic material having a Shore hardness component greater than about 50D and less than about R100, which is selected from polyethylene terephthalate glycol (PETG), polysulfone, thermoplastic polyurethane (TPU), and combinations thereof; and one or more surface layers comprise a soft polymer having a Shore hardness component of about 50A to about 50D, which is selected from TPU, TPE, elastic copolyester, TPV, EMA, EBA, and combinations thereof.

[0021] One embodiment of this aspect of the invention provides a dental brace, wherein an active ingredient and / or therapeutic composition is added to the outer soft layer, which is selected from an analgesic, an antibacterial agent, a tooth whitening agent, and an agent that enhances one or more dental treatments. A preferred embodiment of this aspect provides a dental brace, wherein the outer soft layer releases the active ingredient and / or therapeutic composition, such as an analgesic, an antibacterial agent, a tooth whitening agent, or other agents that enhance one or more dental treatments over a period of time.

[0022] A preferred embodiment of this aspect of the invention provides a dental brace wherein the one or more soft skin layers comprise about 10% to about 30% of the total thickness of the dental brace. Another preferred embodiment provides a dental brace wherein the one or more soft skin layers comprise about 5% to about 25% of the total thickness of the dental brace.

[0023] In another preferred embodiment, a dental brace is provided wherein the soft surface layer has a Shore hardness component greater than about 50A and less than about 80A.

[0024] Another preferred embodiment provides a dental appliance wherein the dental appliance has a modulus of about 200,000 psi but less than about 500,000 psi and an applied initial force of about 120 lbs but less than about 300 psi.

[0025] In another aspect of the present invention, a dental brace is provided wherein the soft skin layer has a hard core layer sandwiched between two soft plastic layers, wherein the hard core layer is approximately 24 mils thick and each soft skin layer is approximately 3 mils thick.

[0026] Another aspect of the present invention provides a dental brace, wherein the outer soft layer comprises an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances one or more dental treatments. A preferred embodiment of this aspect provides a dental brace, wherein the outer soft layer releases the active ingredient and / or therapeutic composition, such as an analgesic, an antibacterial, a tooth whitening agent, or other agent that enhances one or more dental treatments, over a period of time. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 : Figure 1 A dental brace is shown. The inner surface of the dental brace is the surface marked A1, which contacts the tooth / tooth when the dental brace is placed in the appropriate position on the tooth / tooth. The inner surface generally comprises a material softer than the material contained therein. The outer surface of the dental brace is marked A2, which is generally exposed to the inside of the cheek and does not contact the tooth / tooth on which the dental brace is placed. The outer surface (A2) generally also comprises a softer material similar to the inner surface (A1), which may be made of the same or different softer material. The inner and outer surfaces are together covered with a generally harder retaining layer B, i.e., the core layer, so that the harder layer B is entirely contained in the inner and outer layers. Regardless of whether layers A1 and A2 are made of the same material or different materials and their softness, the two layers are seamlessly connected to the core layer B and form the outer surface layer of the laminated structure.

[0028] Figure 2 : Figure 2 Shown is a cross-section of a tooth, surrounding gums, and a dental brace. The gum area (1) surrounds the tooth (2). The dental brace (3) is on top of the tooth. The inner surface (A1) of the dental brace is in contact with the tooth (2). The inner surface typically comprises a softer material. The outer layer / surface (A2) is located on the opposite side of the inner layer / surface (A1). The outer surface (A2) is typically exposed on the inside of the cheek and is not in contact with the tooth / teeth on which the dental brace is placed. The outer surface (A2) typically also comprises a softer material similar to the inner surface (A1), which may be made of the same or different softer material. The inner and outer surfaces are together covered with a typically harder retaining layer B, such that the harder layer B is sandwiched between the inner and outer layers. Regardless of whether layers A1 and A2 are made of the same material or different materials and their softness, the two layers are seamlessly connected to the core layer B and form the outer surface of the laminated structure.

[0029] Figure 3 : Figure 3 Shown is a single layer dental aligner structure having a thickness of about 15-30 mils. This uses transparent high temperature polymers and polymer blends thereof, particularly polysulfones (PSU polysulfone, PES polyethersulfone, PPSU polyphenylsulfone, and about 0.05 wt % to about 2 wt % of a blueing dye. The blue pigment is selected from the family of ultramarine chemical components, for example, ultramarine is a complex sodium silicate containing sulfur and aluminum, and its chemical formula is Na7A l6 SiO 24S3. The intense and distinctive blue color is caused by the unpaired electrons in the sulfhydryl radical anion S3-. As described in https: / / colourlex.com / project / ultramarine-natural / , it is chemically stable under normal conditions and can also resist high temperatures. This structure increases the improved structural application of forces for tooth movement and the reduction of creep / stress relaxation.

[0030] Figure 4 : This figure shows a multi-layer high temperature hybrid dental brace. The first layer includes a hard outer layer (also called an outer "stretch" surface layer) of about 3 to 20 mils, which is selected from homopolymers and copolymers of polysulfones, such as PSU, PES, PPSU, and blends thereof, which have a Rockwell R hardness greater than about 70 and less than about 110 or a Shore D hardness of at least R100. When the brace is placed in the mouth, this layer contacts the tongue and cheek. The second inner core layer contains an amorphous (transparent) rigid copolyester and its blends + 0.05 wt%-2 wt% of a bluing dye, and its Rockwell R scale hardness is greater than about 60 and less than about 110. The third layer contains an elastomer with a Shore hardness of about 80A - an aromatic polyether-based TPU; COPE; SBC, an olefin functional elastomer, which has a thickness of about 1 mil to about 10 mils and contacts the teeth.

[0031] First floor : This layer contacts the teeth and contains an elastomer with a Shore hardness of about 80A - aromatic polyether-based TPU; COPE; SBC, olefin functional elastomer. The thickness of this layer is about 1 mil to 5 mils and is made using casting or co-extrusion (multi-layer core for bonding) or full coating roller coating. This layer provides gripping traction for the teeth and helps tooth movement.

[0032] Second floor : This layer is an intermediate layer, which contains amorphous (transparent) rigid copolyesters and blends thereof + 0.05 wt%-2 wt% of a bluing dye. The thickness of this layer is about 3 mils to about 20 mils, and is made using a cast tandem extrusion process with a surface treatment (corona, plasma, flame, and / or primer). It provides an improved low-cost structural application of forces for tooth / tooth movement, improved creep reduction, and enhanced forming and bonding properties in the laminate.

[0033] Third floor : This layer is located on the outside, in contact with the cheek and tongue, and contains transparent high temperature polymers and their blends - polysulfone (PSU, PES, PPSU) + 0.05 wt%-2 wt% of bluing dye. The thickness of this layer is about 3 mils to about 20 mils, and is made using a casting tandem extrusion process with surface treatment (corona, plasma, flame, and / or primer). It provides improved low creep applications with higher forces for teeth.

[0034] Figure 5 : This picture shows a three-layer high-temperature dental braces.

[0035] First floor : This layer contacts the teeth and contains an elastomer with a Shore hardness of about 80A - aromatic polyether-based TPU; COPE; SBC, an olefin-functional elastomer. The thickness of this layer is about 1 mil to about 4 mils, and it is made using a tandem extrusion or full-coat roller coating process. This layer provides gripping traction for the teeth and helps tooth movement.

[0036] Second floor :This layer is an intermediate layer, which contains transparent high temperature polymers and their blends - polysulfone (PSU, PES, PPSU) + 0.05 wt%-2 wt% of bluing dye. The thickness of this layer is about 15 mils to about 25 mils, and is made using a cast tandem extrusion process with surface treatment (corona, plasma, flame, and / or primer). This layer provides improved structural application of forces for tooth / tooth movement and reduction of creep / stress relaxation.

[0037] Third floor : This layer contacts the cheek / tongue and contains an elastomer with a Shore hardness of about 80A - aromatic polyether-based TPU; COPE; SBC, an olefin-functional elastomer. The thickness of this layer is about 1 mil to about 4 mils and is made using a tandem extrusion or full-coat roll coating process. This layer provides comfort when in contact with the cheek and tongue.

[0038] Figure 6 : This picture shows a multi-layer high temperature hybrid dental braces.

[0039] First floor : This layer contacts the teeth and contains amorphous (transparent) rigid copolyesters and blends thereof + 0.05 wt%-2 wt% of a bluing dye. The thickness of this layer is from about 3 mils to about 20 mils and is made using a cast tandem extrusion process with a surface treatment (corona, plasma, flame, and / or primer). It provides an improved low-cost structural application of forces for tooth / tooth movement, improved creep reduction, and enhanced forming and bonding properties in the laminate.

[0040] Second floor : This layer is the middle layer and contains an elastomer with a Shore hardness of about 80A - aromatic polyether-based TPU; COPE; SBC, an olefin functional elastomer. The thickness of this layer is about 1 mil to about 10 mils, and it is made using casting and coextrusion (for multi-layer core bonding). This layer helps to bond the layers and transfer forces / strains from the outer rigid layer to the teeth / teeth comfortably.

[0041] Third floor: This layer contacts the cheek and tongue and contains a transparent high temperature polymer and its blends - polysulfone (PSU, PES, PPSU) + 0.05 wt% - 2 wt% of a bluing dye. The thickness of this layer is about 3 mils to about 15 mils and is made using a cast tandem extrusion process with surface treatment (corona, plasma, flame, and / or primer). This layer provides structural application of forces for tooth / tooth movement and reduction of creep / stress relaxation.

[0042] Figure 7 : This figure shows a two-layer hybrid dental aligner. The thickness of each layer is about 5 mils to about 25 mils.

[0043] First layer: This layer is close to the teeth and contains amorphous (transparent) rigid copolyesters and blends thereof + 0.05 wt% - 2 wt% of bluing dye. This layer is made using a cast tandem extrusion process with surface treatment (corona, plasma, flame and / or primer). It provides improved low cost structural application of forces for tooth / tooth movement, improved creep reduction, and enhanced forming and bonding properties in the laminate.

[0044] Second floor : This layer is in contact with the cheek / tongue and contains transparent high temperature polymers and their blends - polysulfones (PSU, PES, PPSU) + 0.05 wt% - 2 wt% of bluing dye. This layer is made using a cast tandem extrusion process with surface treatment (corona, plasma, flame and / or primer). This layer provides improved structural application of forces for tooth / tooth movement and greater reduction in creep / stress relaxation.

[0045] Figure 8 :This figure shows the two-layer high temperature corrector structure.

[0046] First layer: This layer is the inner layer that contacts the teeth and contains an elastomer with a Shore hardness of about 80A - an aromatic polyether-based TPU; COPE, or an olefin-functional elastomer. The thickness of this layer is about 1 mil to about 4 mils, and it is made using a tandem extrusion or full-coat roller coating process. This layer provides gripping traction to the teeth to help with movement and comfort in applying force.

[0047] Second floor : This layer contacts the cheek / tongue and contains a transparent high temperature polymer and its blends - polysulfone (PSU, PES, PPSU) + 0.05 wt%-2 wt% of a bluing dye. The thickness of this layer is about 15 mils to about 25 mils and is made using a cast tandem extrusion process with surface treatment (corona, plasma, flame, and / or primer). This layer provides improved structural application of forces for tooth / tooth movement and greater reduction in creep / stress relaxation.

[0048] Fig. 9 :This figure shows the three-layer high temperature corrector structure.

[0049] First floor : This layer contacts the cheek / tongue and contains a transparent high temperature polymer and its blends - polysulfone (PSU, PES, PPSU) + 0.05 wt%-2 wt% of a bluing dye. The thickness of this layer is about 3 mils to about 15 mils and is made using a cast tandem extrusion process with surface treatment (corona, plasma, flame, and / or primer). It provides improved structural application of forces for tooth / tooth movement and greater reduction in creep / stress relaxation.

[0050] Second floor : This layer is the middle layer and contains an elastomer with a Shore hardness of about 80A - aromatic polyether-based TPU; COPE; SBC, an olefin functional elastomer. The thickness of this layer is about 1 mil to about 15 mils, and it is made using casting and coextrusion (for multi-layer soft core bonding). This layer helps to bond the layers and comfortably transfer forces / strains from the outer rigid surface layer to the teeth / teeth, thereby reducing creep.

[0051] Third floor : This layer is in contact with the tooth / teeth and contains transparent high temperature polymers and their blends - polysulfones (PSU, PES, PPSU) + 0.05 wt% - 2 wt% of bluing dye. The thickness of this layer is about 3 mils to about 15 mils and is made using a cast tandem extrusion process with surface treatment (corona, plasma, flame, and / or primer). It provides improved structural application of forces for tooth / teeth movement and greater reduction in creep / stress relaxation.

[0052] Fig.10 : This figure shows a dental brace with a two-layer hybrid structure. The thickness of each layer is about 5 mils to about 20 mils.

[0053] First floor : This layer is in contact with the cheek / tongue and contains transparent high temperature polymers and their blends - polysulfones (PSU, PES, PPSU) + 0.05 wt% - 2 wt% of bluing dye. This layer is made using a cast tandem extrusion process with a surface. It provides improved structural application of forces for tooth / tooth movement and greater reduction in creep / stress relaxation.

[0054] Second floor : This layer is in contact with the tooth / teeth and contains amorphous (transparent) rigid copolyesters and their blends + 0.05 wt% - 2 wt% of bluing dye. This layer is made using cast extrusion and surface treatment (corona, plasma, flame and / or primer). It provides a high transparency, low cost option. It also helps in structural application of forces for tooth / teeth movement and low creep options.

[0055] Fig.11 : This picture shows a three-layer high-temperature hybrid structure dental braces.

[0056] First floor : This layer is about 1 mil to 8 mils thick, which contacts the cheek / tongue and contains a transparent high temperature polymer and its blends - polysulfone (PSU, PES, PPSU) + 0.05 wt%-2 wt% of a bluing dye. This layer is made using a cast extrusion and surface treatment process (corona, plasma, flame and / or primer). It provides an improved low creep application with higher forces for tooth / tooth movement.

[0057] Second floor : This layer is about 12 mils to about 25 mils thick and is an intermediate layer that contains amorphous (transparent) rigid copolyesters and blends thereof + about 0.05 wt% to 2 wt% of a bluing dye. This layer is made using a cast tandem extrusion process. It provides improved low-cost structural applications for forces of tooth / tooth movement, serves as a bonding layer for high temperature layers, and provides enhanced thermoforming capabilities in final applications.

[0058] Third floor : This layer is about 1 mil to 8 mils thick, it contacts the tooth / teeth, and contains a clear high temperature polymer and its blends - polysulfone (PSU, PES, PPSU) + about 0.05 wt% - 2 wt% of a bluing dye. This layer is made using a cast extrusion and surface treatment process (corona, plasma, flame and / or primer). It provides an improved low creep application with higher forces for tooth / teeth movement and combines with the first layer to form a rigid "I" beam type structure to optimize efficiency. DETAILED DESCRIPTION

[0059] In one embodiment, the present invention provides a dental brace comprising a component made of a plastic material having a Rockwell R hardness greater than about 50 and less than about 130, wherein the component is selected from polyethylene terephthalate glycol (PETG), rigid thermoplastic polyurethane (r-TPU), polysulfone, and combinations thereof.

[0060] A preferred embodiment provides a dental brace having a total thickness of about 15 mils to about 30 mils. Another preferred embodiment provides a dental brace, wherein the modulus of the dental brace is in the range of about 200,000 psi but less than about 500,000 psi, and the initial force applied is in the range of about 120 lbs to about 300 lbs.

[0061] Another embodiment provides a dental brace, wherein the dental brace material contains an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and an agent that enhances dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and other agents that enhance dental treatment over a period of time.

[0062] In another embodiment, the present invention provides a dental brace comprising an outer layer and an inner component, wherein the outer layer is soft and comprises a polymer with a Shore hardness of about 50A to about 60D, which is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic co-poly (ether or ester-ester), elastic co-poly (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof; the inner component is harder than the outer layer and is composed of a plastic material with a Rockwell R hardness greater than about 60 and less than about 115, wherein the plastic material is selected from polyethylene terephthalate glycol (PETG), rigid thermoplastic polyurethane (r-TPU), polysulfone, and combinations thereof.

[0063] A preferred embodiment of this aspect of the invention provides a dental brace, wherein the outer soft layer accounts for about 10% to about 20% of the total thickness of the dental brace. Another preferred embodiment provides a dental brace, wherein the outer soft layer accounts for about 5% to about 15% of the total thickness of the dental brace. Another preferred embodiment provides a dental brace, wherein the modulus of the dental brace is about 200,000 psi and less than about 500,000 psi, and the initial force applied is about 120 lbs but less than about 300 lbs. Another embodiment provides a dental brace, wherein the dental brace material contains an active ingredient and / or a therapeutic composition selected from analgesics, antibacterial agents, tooth whitening agents, and agents that enhance dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases an active ingredient and / or a therapeutic composition selected from analgesics, antibacterial agents, tooth whitening agents, and other agents that enhance dental treatment over a period of time.

[0064] Another aspect of the present invention provides a dental brace comprising a multilayer material selected from a core layer or inner layer, and a surface layer or outer layer, wherein the core layer has a hard component made of a plastic material with a Rockwell R hardness greater than about 60 and less than about 115, which is selected from polyethylene terephthalate glycol (PETG), rigid thermoplastic polyurethane (r-TPU), polysulfone, and combinations thereof; the surface layer comprises a soft polymer with a Shore hardness of about 50A to about 60D, which is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copolymer (ether or ester-ester), elastic copolymer (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof.

[0065] A preferred embodiment of this aspect provides a dental brace, wherein the soft surface layer accounts for about 10% to about 30% of the total thickness of the dental brace. Another preferred embodiment provides a dental brace, wherein the soft surface layer accounts for about 5% to about 25% of the total thickness of the dental brace. Another preferred embodiment provides a dental brace, wherein the core layer has a hard component made of a plastic material having a Rockwell R hardness greater than about 90 and less than about 110, and the Shore hardness of the soft surface layer is greater than about 60A and less than about 50D.

[0066] Another preferred embodiment provides a dental brace, wherein the modulus of the dental brace is about 200,000 psi but less than about 500,000 psi, and the initial force applied is about 120 lbs but less than about 300 psi. Another preferred embodiment provides a dental brace, wherein the soft skin layer has a hard core layer sandwiched between two soft plastic layers, wherein the hard core layer has a thickness of about 24 mils and each soft skin layer has a thickness of about 3 mils.

[0067] Another embodiment provides a dental brace, wherein the dental brace material contains an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and an agent that enhances dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and other agents that enhance dental treatment over a period of time.

[0068] Another aspect of the present invention provides a dental brace comprising a single layer of a thermoplastic material having a Rockwell R hardness greater than about 50 and less than about 130, wherein the thermoplastic material is selected from the family of homopolymers and copolymers of polysulfone and blends thereof.

[0069] Preferred embodiments of this aspect of the invention provide a dental brace wherein the total thickness of the thermoplastic material is from about 15 mils to about 30 mils; the modulus of elasticity of the thermoplastic homopolymers and copolymers of polysulfone is from about 200,000 psi but less than about 500,000 psi. Another preferred aspect provides a dental brace wherein the thermoplastic homopolymers and copolymers of polysulfone have an elongation at break of about 10% but less than 200%; wherein the stress relaxation of a monolayer based on the homopolymers and copolymers of polysulfone in a 4% stress relaxation test at room temperature for 24 hours is at least 15% better than that of thermoplastic polyurethane and polyethylene terephthalate glycol. Another preferred aspect provides a dental brace wherein the monolayer based on the homopolymers and copolymers of polysulfone further comprises at least 0.05 wt % but less than 2 wt % of a blueing dye material.

[0070] Another embodiment provides a dental brace, wherein the dental brace material contains an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and an agent that enhances dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and other agents that enhance dental treatment over a period of time.

[0071] Another aspect of the present invention provides a dental brace comprising an outer layer and an inner layer, wherein the outer layer is hard and comprises a thermoplastic material having a Rockwell R hardness greater than about 60 and less than about 110, wherein the thermoplastic material is selected from the family of homopolymers and copolymers of polysulfone and their blends; the inner layer close to the teeth is softer than the outer layer and is composed of a thermoplastic material having a Shore hardness of about 50A to about 60D, and the thermoplastic material is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copolymer (ether or ester-ester), elastic copolymer (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof.

[0072] A preferred embodiment provides a dental brace, wherein the inner soft layer accounts for about 10% to about 20% of the total thickness of the dental brace; wherein the inner soft layer accounts for about 5% to about 15% of the total thickness of the dental brace. Another preferred embodiment provides a dental brace, wherein the modulus of the dental brace is about 200,000 psi and less than about 500,000 psi, and the initial force applied is about 120 lbs but less than about 300 lbs. A preferred embodiment provides a dental brace, wherein the dental brace material contains an active ingredient and / or a therapeutic composition selected from analgesics, antibacterial agents, tooth whitening agents, and agents that enhance dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases an active ingredient and / or a therapeutic composition selected from analgesics, antibacterial agents, tooth whitening agents, and other agents that enhance dental treatment over a period of time.

[0073] Another aspect of the present invention provides a dental brace comprising a multilayer material selected from a core layer or inner layer, and a surface layer or outer layer, wherein the core layer has a rigid thermoplastic material having a Rockwell R hardness greater than about 60 and less than about 110, wherein the thermoplastic material is selected from the family of homopolymers and copolymers of polysulfone and their blends; the surface layer comprises a soft thermoplastic polymer having a Shore hardness of about 50A to about 60D, and the thermoplastic material is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastomeric copolymer (ether or ester-ester), elastomeric copolymer (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof.

[0074] A preferred embodiment provides a dental brace, wherein the outer soft surface layer accounts for about 10% to about 30% of the total thickness of the dental brace. Another preferred embodiment provides a dental brace, wherein the soft surface layer accounts for about 5% to about 25% of the total thickness of the dental brace. Another preferred embodiment provides a dental brace, wherein the core layer has a rigid thermoplastic material with a Rockwell R hardness greater than about 90 and less than about 110, and the Shore hardness of the soft surface layer is greater than about 55A and less than about 80A. Another preferred embodiment provides a dental brace, wherein the soft surface layer has a hard core layer sandwiched between two soft plastic layers, wherein the hard core layer has a thickness of about 24 mils and the thickness of each soft surface layer is about 3 mils.

[0075] Another preferred embodiment provides a dental brace, wherein the dental brace material contains an active ingredient and / or a therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and an agent that enhances dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases an active ingredient and / or a therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and other agents that enhance dental treatment over a period of time.

[0076] Another aspect of the present invention provides a dental brace comprising a multilayer material selected from a core layer or inner layer, and a surface layer or outer layer, wherein: the core layer has a soft thermoplastic polymer with a Shore hardness of about 50A to about 60D, and the thermoplastic material is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copolymer (ether or ester-ester), elastic copolymer (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof; the surface layer comprises a rigid thermoplastic material with a Rockwell R hardness greater than about 60 and less than about 110, wherein the thermoplastic material is selected from the family of homopolymers and copolymers of polysulfone and their blends.

[0077] A preferred embodiment provides a dental brace, wherein the dental brace material contains an active ingredient and / or a therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and an agent that enhances dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases an active ingredient and / or a therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and other agents that enhance dental treatment over a period of time.

[0078] The present invention provides, in one aspect thereof, a dental brace, wherein the dental brace is softer than conventional dental braces having a Shore D hardness greater than 75 (>75). In one embodiment of this aspect, a dental brace is provided that is softer than conventional braces and is capable of adjusting the forces applied to the teeth based on the needs of the treatment regimen and the patient's tolerance for pain. In another embodiment, a dental brace is provided wherein creep is minimized to improve malocclusion treatment (i.e., the forces applied by the material to the teeth are more uniform, particularly during the first 24 hours of wearing the brace). Preferred embodiments of this aspect of the invention provide a dental brace that is thinner than conventional dental braces and further provides a lower coefficient of friction for easier installation and removal on the teeth while still effectively clamping the teeth to apply corrective forces.

[0079] The present invention provides a dental brace that utilizes a specific polymer or combination of polymers and thickness to achieve the desired force distribution and minimize creep - for example, the polymer is a combination of polysulfone alone or polyester. Polyester blends are softer and can be used alone as a "single layer" brace or in combination with an outer elastic layer of TPU, PETG or other copolymers or terpolymers. The dental brace of the present invention includes materials that can provide sustained release capabilities, especially softer materials. The sustained release aspect can release / deliver active ingredients and / or therapeutic compositions, such as analgesics, antibacterial agents, tooth whitening agents or other agents that enhance dental treatment.

[0080] Another aspect of the present invention provides a single or single-layer dental brace comprising a "comfortable plastic" made by a single-layer extrusion process or by additive manufacturing (3D printing). This single or single-layer dental brace is composed of a material selected from a relatively hard, strong TPU, PETG, PC, polysulfone, or all hard segments, pure polymers or blends of hard TPU, and a soft material selected from a soft thermoplastic elastic polyurethane, elastic polyester, polyamide, styrene block copolymer, TPV, EMA, EBA, and other TPE, or pure polymers or blends of TPO. The soft component content of the dental brace accounts for about 3% to about 50% of the total material of the dental brace.

[0081] Another embodiment of this aspect provides a dental brace constructed of a material having a Shore hardness of about 50D to about R100 and a modulus of about >200,000 psi to about less than 500,000 psi and an initial force of about >120 lbs to less than about 300 lbs, the overall thickness of the brace being about 30 mils. Another preferred embodiment provides a dental brace constructed of a material having a Shore hardness of about 70D to about R100 and a force of about 200 lbs to about 275 lbs.

[0082] The hard component will be the “working” part of the formula that moves the teeth, while the soft component provides a softer, more compliant comfort and more efficient plastic-to-tooth force transmission.

[0083] Another aspect of the invention provides a dental brace comprising two layers of comfortable plastic. One embodiment of this aspect provides a dental brace comprising an inner layer or base layer made of a strong, hard plastic such as PETG, PC, polysulfone, TPU, etc., which provides the "working" part of the plastic piece that moves the teeth. The surface layer or outer layer comprises a soft polymer such as TPU, TPE, elastomeric copolyester, EMA, EBA, etc., which provides a comfortable layer on the hard base layer and is able to effectively conform to the surface contours of the teeth and transmit tooth moving forces.

[0084] Another embodiment of this aspect provides a dental brace, wherein the soft surface layer comprises about 3% to about 20% of the total thickness of the dental brace. Another embodiment provides a dental brace, wherein the Shore hardness of the soft surface layer is in the range of about 40A to about 50D. Another preferred embodiment provides a dental brace, which is composed of a material with a Shore hardness of about 70D to about R100 and a force of about 200 lbs to about 275 lbs.

[0085] Another aspect of the invention provides a dental brace having more than two layers of comfort plastic. One embodiment of this aspect provides a dental brace comprising a core or inner layer made of a strong, hard plastic such as PETG, PC, polysulfone, TPU, etc., which provides the "working" portion of the plastic piece that moves the teeth. The outer or surface layer of this embodiment comprises a soft polymer such as TPU, TPE, elastomeric copolyester, EMA, EBA, etc., which provides a comfort layer and force transfer from the hard base layer.

[0086] Another embodiment of this aspect provides a dental brace, wherein the outer soft surface layer comprises about 3% to about 30% of the total thickness of the dental brace. Another embodiment provides a dental brace, wherein the Shore hardness of the soft surface layer is in the range of about 40A to about 50D. Another preferred embodiment provides a dental brace, which is composed of a material with a Shore hardness of about 70D to about R100 and a force of about 200 lbs to about 275 lbs.

[0087] Another embodiment of this aspect provides multiple "soft" layers that balance comfort, conformity to tooth contours, grip and adjustment and optimize comfort for dental and / orthodontic treatment.

[0088] Another embodiment of this aspect of the invention provides a dental brace having a multi-layer structure using a "working" plastic as a hard surface layer and a soft plastic core layer (potential chemistries described above). The core layer comprises about 5% to about 60% of the total thickness.

[0089] definition

[0090] As used herein, the term "dental braces" refers to an orthodontic device that is typically clear, made of plastic, and used to adjust teeth. Clear or transparent braces are an alternative to traditional braces and are designed to help guide the teeth into their correct position. Similar to braces, clear braces use progressive forces to control tooth movement, but without wires or brackets. Dental braces are traditionally made of strong plastic materials and manufactured to fit each individual's mouth. If a series of braces is required, each brace moves the teeth in increments until the desired movement is achieved. The dental braces of the present invention are made of a combination of soft and hard plastic materials, as discussed in this specification.

[0091] As used herein, the term "plastic material" refers to a material used to manufacture dental braces. An example of a plastic material is an elastic thermoplastic, which, when used to manufacture dental braces, helps to apply pressure to the teeth / teeth to move the teeth to a desired position.

[0092] As used herein, the term "Shore Hardness" is a measure of a material's resistance to being pressed. Different Shore Hardness scales are used to measure the hardness of different materials. These scales were invented so that people could discuss these materials and have a common reference point. The Shore 00 Hardness scale measures very soft rubbers and gels. The Shore A Hardness scale measures the hardness of flexible mold rubbers, ranging from very soft and flexible to medium and somewhat flexible to hard with almost no flexibility. Semi-rigid plastics can also be measured at the high end of the Shore A scale. The Shore D Hardness scale measures the hardness of hard rubbers, semi-rigid plastics, and rigid plastics.

[0093] The term "total thickness" is intended to mean the thickness of the dental appliance, including the soft layer and the rigid layer together.

[0094] As used herein, the term "modulus" refers to the modulus of elasticity of a material or device, which is defined as the slope of the stress-strain curve expressed in pounds per square inch (psi).

[0095] The term "outer layer" refers to the outer part of the dental brace, which is usually softer than the layers it is wrapped around, and is the part that is in direct contact with the teeth / teeth, as well as the tongue and the inside of the cheeks.

[0096] As used herein, the term "inner component" refers to the generally harder / rigid material of a dental brace. The inner component is generally completely encased within a generally softer outer layer. Illustrative examples include Figure 1 As shown in Part B.

[0097] As used herein, the term "hard component" refers to the internal component described above. An illustrative example of a hard component is a plastic material having a Shore hardness component greater than about 55D and less than about R100 selected from polyethylene terephthalate glycol (PETG), polysulfone, thermoplastic polyurethane (TPU), and combinations thereof.

[0098] The term "TPE" means thermoplastic elastomer. The term "TPU" means thermoplastic polyurethane. As used herein, the term "EMA" means ethylene methyl acrylate copolymer. As used herein, the term "EBA" means ethylene butyl acrylate copolymer. The term "TPV" means thermoplastic vulcanizate.

[0099] As used herein, the term "initial force" refers to the initial force in pounds (lbs) applied to the teeth when the dental braces are placed on top of the teeth. The initial force is related to the type of material used to construct the dental braces.

[0100] As used herein, the term "pain reliever" refers to a drug that is administered to an individual to relieve physical pain, including headaches, muscle aches, arthritis, or other aches and pains. There are many different pain relievers, each with advantages and risks. Certain types of pain respond better to certain drugs than to others. Each person may also respond slightly differently to a pain reliever. An example of a pain reliever is an over-the-counter (OTC) medication, such as acetaminophen (Tylenol). Another example of a pain reliever is a nonsteroidal anti-inflammatory drug (NSAID). Examples of NSAIDs are aspirin, naproxen (Aleve), and ibuprofen (Advil, Motrin).

[0101] As used herein, the term "antibacterial agent" refers to a group of materials that resist pathogenic bacteria. Therefore, by killing or reducing the metabolic activity of bacteria, their pathogenic effects in the biological environment can be minimized. In addition, these materials can prevent bacterial plaque from accumulating in the oral environment, thereby reducing the incidence of diseases associated with plaque (such as caries). However, it should be noted that antibacterial agents do not necessarily have anti-plaque accumulation properties. Illustrative examples of antibacterial agents are amoxicillin, doxycycline, cephalexin, ciprofloxacin, clindamycin, metronidazole, and azithromycin.

[0102] As used herein, the term "tooth whitening agent" is used to make teeth appear whiter. These materials can remove stains or other discolorations on the surface of teeth. Hydrogen peroxide is the most commonly used active ingredient in tooth whitening products and is provided in the form of hydrogen peroxide or carbamide peroxide. Baking soda is reported to be a low-abrasive, effective stain remover and tooth whitener.

[0103] As used herein, the term "thermoplastic" refers to a plastic polymer material that becomes moldable at a specific elevated temperature and solidifies upon cooling. Most thermoplastics have a high molecular weight. The polymer chains are bound by intermolecular forces, which rapidly weaken as the temperature rises, producing a viscous liquid. In this state, thermoplastics can be reshaped and are commonly used to produce parts by various polymer processing techniques such as injection molding, compression molding, calendering, and extrusion. Thermoplastics are distinguished from thermosetting polymers (or "thermosets") that form irreversible chemical bonds during the curing process. Thermosets do not melt when heated, but typically decompose upon cooling and do not reshape.

[0104] As used herein, the term "Rockwell R hardness" refers to the hardness of a material by measuring the penetration depth of an indenter under a large load compared to the compression produced by a preload. There are different scales represented by a single letter, which use different loads or indenters. The result is a dimensionless number. The indenter can be a diamond tip, steel, or tungsten carbide ball. The Rockwell test procedures used in the plastics industry are ASTM D785 and ISO2039-2 and are summarized in https: / / omnexus.specialchem.com / polymer-properties / properties / hardness-rockwell-m?src=omproperty&utm_source=selection-resources&utm_medium=polymer-properties&utm_campaign=hardness.

[0105] The term "homopolymer of polysulfone" (PSU) is intended to denote a family of high-performance thermoplastics containing aryl-SO2-aryl subunits. These polymers are known for their toughness and stability at high temperatures. Three polysulfones are used industrially, namely polysulfone (PSU), polyethersulfone (PES) and polyphenylsulfone (PPSU). They can be used in a temperature range of -100 to +200 °C and are used in electrical devices, vehicle construction and medical technology. They consist of para-linked aromatics, sulfonyl and ether groups and partly alkyl groups. As described at https: / / en.wikipedia.org / wiki / Polysulfone, polysulfones have excellent heat and oxidation resistance, resistance to hydrolysis in aqueous and alkaline media and good electrical properties.

[0106]

[0107] Polysulfones used herein include those that are rigid and have a Rockwell R hardness of about 60 to about 130. Illustrative examples and sources are listed below:

[0108] PSU:Solvay Udel P-1700CL2611 CMP

[0109] PSU:YOUJU XIN CAIParyls F3150

[0110] PSU:BASF Ultrason S

[0111] PESU: Solvay Veradel HC A301 NT

[0112] PESU:BASF Ultrason E

[0113] PPSU:Solvay Radel R5500 NT

[0114] PPSU:BASF Ultrason P

[0115] TPU Manufacturer / Trade Name / Grade:

[0116] “Hard”: Lubrizol Isoplast 2530

[0117] "Hard": Covestro RxT76D

[0118] "Soft": Covestro RxT85A

[0119] “Soft”: Lubrizol Tecothane TT1095A

[0120] TPE olefin-based:

[0121] EVA: Celanese Vital Dose MT2U01

[0122] EBA:Dupont Elvaloy HP4051

[0123] EMA:Arkema Lotryl 28MA07

[0124] SBC:Ineos Styroflex 2G66

[0125] PETGg:

[0126] Eastman Tritan MP100

[0127] Eastman Eastar 6763

[0128] TPV:

[0129] ExxonMobil Santoprene TPV 181-55MED

[0130] PC:

[0131] Sabic 3108

[0132] The term "copolymers of polysulfones" is intended to mean dihydroxy terminated polysulfones with other oligomers (low molecular weight polymers) or polymers, such as polyethylene glycol or polydimethylsiloxane materials, such as those described in https: / / www.sciencedirect.com / science / article / abs / pii / S0142961205006058 and https: / / onlinelibrary.wiley.com / doi / abs / 10.1002 / pol.1971.150091105, to name a few.

[0133] The term "mil" is used herein as a measure of thickness and is equal to one thousandth of an inch, or 0.001 inch. One mil is equal to 0.0254 mm (millimeter).

[0134] The abbreviation "MPa" stands for Megapascal, which is the x1000000 multiple of the Pascal, the SI unit of pressure or force. As stated in https: / / en.wikipedia.org / wiki / Pascal_(unit), 1 Megapascal is equal to 1,000,000 Pascals or 145.04 psi.

[0135] The term "elongation at break" is intended to refer to a material property determined by the ratio of the changed length after a specimen breaks in a tensile test to the initial length. It indicates the ability of a material to resist a change in shape without forming a crack, as described in https: / / www.wikidata.org / wiki / Property:P5811.

[0136] Example:

[0137] The dental braces of the present invention include a soft component / layer / surface and a hard / rigid layer / component as described above. The following examples illustrate different dental braces of the present invention.

[0138] Example 1 - Multi-layered braces: The following example illustrates a dental brace with three layers, where the soft component is about 3 mils thick and the hard component is about 24 mils thick. Two 3 mil soft layers are on the outside, in contact with the teeth / teeth and the inside of the cheeks and tongue. The two soft layers can be different from each other because they are on opposite sides of the brace (one is in direct contact with the teeth and the other is in direct contact with the inside of the cheeks and tongue). These soft layers can have different thicknesses, and together they completely encapsulate the hard / rigid layers.

[0139] For all examples below, "R100" = Rockwell Hardness R100

[0140] Three-layer orthotic device:

[0141]

[0142]

[0143] The thickness of the soft layer may range from about 3 mils to about 10 mils.

[0144] Example 2 - Multi-layered brace: This embodiment differs from Example 1 in that the hard / rigid layer encapsulates the soft layer, and the two rigid layers can be different from each other because they are located on opposite sides of the aligner (one in direct contact with the teeth and the other in direct contact with the inside of the cheek and tongue). The details of the hard / rigid and soft layers / assemblies are as follows. The thickness of each layer in this embodiment is about 10 mils.

[0145] One or more hard layers:

[0146]

[0147] Example 3 - Two-layer orthotic device: The following example illustrates a dental appliance having two layers, wherein the soft component is about 4 mils thick and the hard component is about 26 mils thick, with the soft layer contacting the teeth.

[0148] Two layers:

[0149]

[0150] Example 4 - Single / Single Layer Aligner: The following embodiments illustrate dental appliances having a single or monolayer having a hard / rigid component with a thickness ranging from about 15 mils to about 30 mils.

[0151] Single layer:

[0152]

[0153] Example 5 - Multilayer high temperature hybrid dental appliance The following example illustrates a multilayer dental appliance made of three layers. The first layer is about 5 to 20 mils thick and will contact the teeth when placed in the mouth. It is made of amorphous, transparent, rigid copolyesters and blends thereof with about 0.05% to about 2% of a bluing dye agent by total weight. The second layer (core layer) is about 1 to about 10 mils thick and comprises an aromatic polyether-based thermoplastic polyurethane (TPU) of at least 80 Shore A, COPE (copolyetherester), olefin functional elastomer, styrene butadiene block copolymer. The third layer (also known as the outer "stretch" skin) is about 3 to about 15 mils thick and comprises a transparent high temperature polymer and blends thereof selected from polysulfones (PSU, PES and PPSU) and about 0.05% to about 2% of a bluing dye agent by total weight.

[0154] One or more hard mix layers:

[0155]

[0156] Example 6 - Three-layer high temperature dental braces :

[0157] As shown below, the outer layer (i.e., one of the outer layers is close to the teeth and the other surface layer is in contact with the cheek and tongue) is selected from a soft material with a Shore A of about 80, selected from an aromatic polyether-based TPU or a copolyetherester or an olefin functional elastomer, and the inner layer (also called the core layer) is selected from polysulfones (PSU, PES and PPSU) and a blueing dye agent accounting for about 0.05% to about 2% of the total weight.

[0158]

[0159] Example 7 - Two-layer high temperature dental braces :

[0160] As shown below, in the multi-layer dental braces, the outer layer (also called the "outer stretch" surface layer) is selected from a hard material based on homopolymers and copolymers of polysulfone and their blends with blueing dyes, and the inner layer close to the teeth is selected from a soft material with a Shore A of about 80, which is selected from aromatic polyether-based TPU or copolyetherester or olefin-functional elastomer.

[0161] Two layers:

[0162]

[0163] The dental braces of the present invention provide enhanced sustained force and reduced polymer creep (or stress relaxation) to the teeth at a lower thickness, thereby helping to reduce the overall time required to move the teeth, reducing pain, and can help reduce the need for mid-range corrections. In some cases, it can also reduce the overall number or retainers required for a particular treatment.

[0164] Examples of dental appliances comprising therapeutic agents are provided below:

[0165] Drug release braces

[0166] Three-layer dental braces :

[0167]

[0168] Two-layer dental braces :

[0169]

[0170]

[0171] Single layer dental braces :

[0172]

[0173] It should be understood that one or more therapeutic agents may be incorporated into any one or more of the multiple layers of the dental appliance.

[0174] Tables and Figures

[0175] background : The following samples were subjected to 4% stress relaxation testing (RT 72 hours) according to Bixby's internal procedures. All samples were 30 mils thick unless otherwise noted.

[0176] result : Force / Load (lbf) values ​​are reported at the time intervals specified in the table below.

[0177] Table I

[0178]

[0179] Table I Table 1 lists the stress relaxation of dental braces with single-layer PSU, TPU (control), PETG A, and PETG B, each with a thickness of 30 mils. It also includes a three-layer brace with a soft surface layer of 85A hardness and a central rigid core layer of PETG B; a single-layer brace made of 30 mil PSU and 19 mil thickness; a three-layer brace with a rigid PSU surface layer and a 34 mil 85A TPU soft core layer; a two-layer brace with a PSU base and an 85A TPU surface layer; and a commercially available brace with a hard surface layer and a soft core layer. The "0" column is time zero, showing the starting force at time zero and the loss of force over a period of time, with intervals of a quarter hour, half an hour, three quarters of an hour, 1, 2, 3... 72 hours.

[0180] Figure I

[0181]

[0182] Figure I : Figure I depicts the stress loss curves over time for each of the braces in Table I. The initial stress is along the Y-axis and the stress loss is along the X-axis, from left to right.

[0183] Table II

[0184]

[0185] Table IITable II lists the stress relaxation of dental braces with single-layer PSU, TPU (control), PETG A, and PETG B, each with a thickness of 30 mils. Also included are a three-layer brace with a soft surface layer of 85A hardness and a central rigid core layer of PETG B; a 19-mil thick single-layer brace made of PSU; a three-layer brace with a rigid PSU surface layer and a 34-mil 85A TPU soft core layer; a two-layer brace with a PSU base and an 85A TPU surface layer; and a commercially available brace with a hard surface layer and a soft core layer. The "0" column is time zero, showing the starting force at time zero and the loss of force over a period of time, with intervals of a quarter hour, half an hour, three quarters of an hour, 1, 2, 3...72 hours.

[0186] Figure / Chart II

[0187]

[0188] Figure / Chart II : Figure / Chart II shows the retained stresses for the orthoses listed in Table II. The orthosis with the least stress loss is on the left.

[0189] Table III

[0190] The area under the curve was calculated after the 4% SR test was performed. Seventy two hour values ​​are reported in Table III below.

[0191]

[0192] Table III Table III lists the areas under the curve calculated after 4% stress relaxation testing (72 hours) for dental braces of single-layer PSU, TPU (control), PETG A, and PETG B with a thickness of 30 mils, respectively. It also includes a three-layer brace with a soft surface layer of 85A hardness and a central rigid core layer of PETG B; a 19-mil thick single-layer brace made of PSU; a three-layer brace with a rigid PSU surface layer and a 34-mil 85A TPU soft core layer; a two-layer brace with a PSU base and an 85ATPU surface layer; and a commercially available brace with a hard surface layer and a soft core layer. The larger the value of the area under the curve, the greater the work done by the material and structure, or the cumulative amount of force applied to move the teeth in 72 hours.

[0193] Figure / Chart III

[0194]

[0195] Figure / Graph III shows the area under the curve for the orthotics listed in Table III.

Claims

1. A dental brace comprising a component made of a thermoplastic material having a Rockwell R hardness greater than about 50 and less than about 130, wherein: The component is selected from polyethylene terephthalate glycol (PETG), rigid thermoplastic polyurethane (r-TPU), polysulfone, and combinations thereof, wherein the total thickness of the dental brace is about 15 mils to about 30 mils, the modulus of the dental brace is in the range of about 200,000 psi but less than about 500,000 psi, and the initial force applied is in the range of about 120 lbs to about 300 lbs.

2. A dental brace comprising an outer layer and an inner component, wherein: The outer layer is soft and comprises a polymer having a Shore hardness of about 50A to about 60D selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastomeric copoly (ether or ester-ester), elastomeric copoly (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA), and combinations thereof; and The inner component is harder than the outer layer and is composed of a plastic material having a Rockwell R hardness greater than about 60 and less than about 115, wherein the plastic material is selected from polyethylene terephthalate glycol (PETG), rigid thermoplastic polyurethane (r-TPU), polysulfone, and combinations thereof, The outer soft layer accounts for about 10% to about 20% of the total thickness of the dental braces. Wherein, the modulus of the dental aligner is about 200,000 psi and less than about 500,000 psi, and the initial force applied is about 120 lbs and less than about 300 lbs.

3. A dental brace comprising a plurality of layers of material selected from a core layer or inner layer and a surface layer or outer layer, wherein: The core layer has a hard component made of a plastic material having a Rockwell R hardness greater than about 90 and less than about 110, which is selected from polyethylene terephthalate glycol (PETG), rigid thermoplastic polyurethane (r-TPU), polysulfone, and combinations thereof; and The skin layer comprises a soft polymer having a Shore hardness of about 60A to about 50D selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastomeric copoly (ether or ester-ester), elastomeric copoly (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA), and combinations thereof, The soft surface layer accounts for about 10% to about 25% of the total thickness of the dental braces. Wherein, the modulus of the dental aligner is about 200,000 psi but less than about 500,000 psi, and the initial force applied is about 120 lbs but less than about 300 psi.

4. A dental brace comprising a single layer of a thermoplastic material having a Rockwell R hardness greater than about 50 and less than about 130, wherein: The thermoplastic material is selected from the family of polysulfone homopolymers and copolymers and blends thereof.

5. The dental brace according to claim 4, wherein: The total thickness of the thermoplastic material is from about 15 mils to about 30 mils.

6. The dental brace according to claim 5, wherein: Thermoplastic homopolymers and copolymers of polysulfone have an elastic modulus of about 200,000 psi but less than about 500,000 psi.

7. The dental brace according to claim 6, wherein: Thermoplastic homopolymers and copolymers of polysulfone have an elongation at break of about 10% but less than 200%.

8. The dental brace according to claim 7, wherein: In a 4% stress relaxation test at room temperature for 24 hours, monolayers based on polysulfone homopolymers and copolymers are at least 15% better at stress relaxation than thermoplastic polyurethane and polyethylene terephthalate diol.

9. The dental brace according to claim 8, wherein: The monolayer based on polysulfone homopolymers and copolymers further comprises at least 0.05 wt % but less than 2 wt % of a blueing dye material.

10. A dental brace comprising an outer layer and an inner layer, wherein: The outer layer is hard and comprises a thermoplastic material having a Rockwell R hardness greater than about 60 and less than about 110, wherein the thermoplastic material is selected from the family of homopolymers and copolymers of polysulfone and their blends; the inner layer close to the teeth is softer than the outer layer and is composed of a thermoplastic material having a Shore hardness of about 50A to about 60D, wherein the thermoplastic material is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copolymer (ether or ester-ester), elastic copolymer (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof.

11. The dental brace according to claim 10, wherein: The inner soft layer comprises about 10% to about 20% of the total thickness of the dental appliance.

12. The dental brace of claim 11, wherein: The inner soft layer comprises from about 5% to about 15% of the total thickness of the dental appliance.

13. The dental brace of claim 12, wherein: The modulus of the dental appliance is about 200,000 psi and less than about 500,000 psi, and the initial force applied is about 120 lbs but less than about 300 lbs.

14. A dental brace comprising a plurality of layers of material selected from a core layer or inner layer and a surface layer or outer layer, wherein: The core layer comprises a rigid thermoplastic material having a Rockwell R hardness greater than about 60 and less than about 110, wherein the thermoplastic material is selected from the family of homopolymers and copolymers of polysulfone and their blends; the surface layer comprises a soft thermoplastic polymer having a Shore hardness of about 50A to about 60D, and the thermoplastic material is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copolymer (ether or ester-ester), elastic copolymer (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof.

15. The dental brace of claim 14, wherein: The outer soft surface layer comprises about 10% to about 30% of the total thickness of the dental appliance.

16. The dental brace of claim 15, wherein: The soft surface layer comprises from about 5% to about 25% of the total thickness of the dental appliance.

17. The dental brace of claim 16, wherein: The core layer has a rigid thermoplastic material with a Rockwell R hardness greater than about 90 and less than about 110, and the soft skin layer has a Shore hardness greater than about 55A and less than about 80A.

18. The dental brace of claim 17, wherein: The soft skin layer has a hard core layer sandwiched between two soft plastic layers, wherein the hard core layer is about 24 mils thick and each soft skin layer is about 3 mils thick.

19. The dental brace of claim 10, wherein: The outer soft layer comprises an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and an agent that enhances dental treatment.

20. A dental brace comprising a plurality of layers of material selected from a core or inner layer and a surface or outer layer, wherein: The core layer has a soft thermoplastic polymer with a Shore hardness of about 50A to about 60D, the thermoplastic material is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copolymer (ether or ester-ester), elastic copolymer (ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof; and The skin layer comprises a rigid thermoplastic material having a Rockwell R hardness greater than about 60 and less than about 110, wherein the thermoplastic material is selected from the family of homopolymers and copolymers of polysulfone and blends thereof.

21. The dental brace of claim 20, wherein: The dental appliance material comprises an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and an agent that enhances dental treatment.

22. The dental brace of claim 4, wherein: The dental appliance material releases the active ingredient and / or therapeutic composition over a period of time, which is selected from analgesics, antibacterial agents, tooth whitening agents and other agents that enhance dental treatment.

23. The dental brace of claim 10, wherein: The dental appliance material releases the active ingredient and / or therapeutic composition over a period of time, which is selected from analgesics, antibacterial agents, tooth whitening agents and other agents that enhance dental treatment.

24. The dental brace of claim 14, wherein: The dental appliance material comprises an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial agent, a tooth whitening agent, and an agent that enhances dental treatment.

25. The dental brace of claim 14, wherein: The dental appliance material releases the active ingredient and / or therapeutic composition over a period of time, which is selected from analgesics, antibacterial agents, tooth whitening agents and other agents that enhance dental treatment.

26. The dental brace of claim 20, wherein: The dental appliance material releases the active ingredient and / or therapeutic composition over a period of time, which is selected from analgesics, antibacterial agents, tooth whitening agents and other agents that enhance dental treatment.

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