Dental braces

Abstract

The present invention provides one or more dental braces that can be better 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 customize treatment based on the patient's stage of treatment, prudent requirements, and pain tolerance.

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 to have their teeth straightened. Braces are used to straighten or move teeth. Braces are connected by wires. Aligners, on the other hand, are a series of tightly fitting, custom-made mouthpieces that span the length of 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 the patient during the first few hours or days of orthodontic treatment. These braces are designed to exert relatively high levels of force on the teeth—hence the braces are typically stiff and thick, which can also make their installation in the teeth difficult and painful. Patients experience this initial pain and discomfort multiple times during their orthodontic treatment, as these procedures involve the use of multiple braces in succession—for example, 20 braces over a six-month period. Furthermore, the discomfort and pain prompt many patients to remove their braces more frequently, which can add weeks or months to their 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 a rigid plastic to provide the physical properties (primarily force) needed for effective correction. Conventional plastic construction also produces suboptimal creep forces - the force applied by the braces drops very rapidly due to early creep of the polymer after installation, especially within the first 24 hours. This creep reduces the effective force available to move teeth through the remainder of the retainer series. 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 design control over force and creep. For the patient, 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 the patient and provide the physician with greater control to customize the treatment based on the patient's treatment stage, precautionary requirements, and pain tolerance. Using a retainer structure with adjustable force and creep curves can create a treatment process that can lead to 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 comprised 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 having a Shore hardness of about 50A to about 60D, which is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copoly(ether or ester-ester), elastic copoly(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 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.

[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 having 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; and the surface layer comprises a soft polymer having a Shore hardness of about 50A to about 60D, which is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copoly(ether or ester-ester), elastic copoly(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 that is 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), 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.

[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 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; and the surface layer comprises a soft thermoplastic polymer 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), 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.

[0013] In one embodiment, the present invention provides a dental brace comprising a component comprised 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 appliance wherein an active ingredient and / or therapeutic composition selected from the group consisting of an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances one or more dental treatments is incorporated into the plastic material. A preferred embodiment of this aspect provides a dental appliance wherein the plastic material releases the active ingredient and / or therapeutic composition, such as an analgesic, an antibacterial, a tooth whitening agent, or another 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 present invention provides the dental brace of claim 4, wherein the outer soft layer comprises from about 10% to about 20% of the total thickness of the dental brace. In another preferred embodiment, the dental brace of claim 5 is provided, wherein the outer soft layer comprises from 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 applied initial force of about 120 lbs and less than about 300 lbs.

[0019] Another embodiment of this aspect of the invention provides a dental appliance wherein an active ingredient and / or therapeutic composition selected from the group consisting of an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances one or more dental treatments is incorporated into the outer soft layer. A preferred embodiment of this aspect provides a dental appliance 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.

[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 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 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 selected from the group consisting of an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances one or more dental treatments is incorporated into the outer soft layer. 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 another agent that enhances 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 from 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 from about 5% to about 25% of the total thickness of the dental brace.

[0023] In another preferred embodiment, a dental appliance 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 appliance is provided wherein the soft skin 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 the group consisting of 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 Shown is a dental brace. The inner surface of the dental brace is the surface marked A1, which is in contact with the tooth / tooth when the dental brace is placed in the appropriate position on the tooth / tooth. This inner surface generally comprises a material that is 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. This outer surface (A2) generally also comprises a softer material similar to the inner surface (A1), which can be made of the same or different softer material. The inner surface and the outer surface are together covered with a generally harder retaining layer B, i.e. the core layer, so that the harder layer B is contained as a whole in the inner layer and the outer layer. Regardless of whether layers A1 and A2 are made of the same material or different materials and their softness, both 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. This outer surface (A2) also typically comprises a softer material similar to the inner surface (A1), which can 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, both 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 appliance structure having a thickness of about 15-30 mils. This utilizes 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, with the chemical formula Na7A l6 SiO 24S3. The intense and distinctive blue color is caused by the unpaired electrons in the sulfhydryl anion S3-. As described at https: / / colourlex.com / project / ultramarine-natural / , it is chemically stable under normal conditions and also resistant to high temperatures. This structure improves the structural application of forces used for tooth movement and reduces 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 comprises an amorphous (transparent) rigid copolyester and its blends + 0.05 wt%-2 wt% of a bluing dye, which has a Rockwell R hardness greater than about 60 and less than about 110. The third layer comprises 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, which contacts the teeth, comprises an elastomer with a Shore hardness of approximately 80A (aromatic polyether-based TPU); COPE; and SBC (olefin-functional elastomer). This layer has a thickness of approximately 1 to 5 mils and is applied using casting, coextrusion (for bonding multi-layer cores), or full-coat roller coating. This layer provides gripping traction and assists tooth movement.

[0032] Second floor This layer is an intermediate layer comprising amorphous (transparent) rigid copolyesters and blends thereof plus 0.05-2% by weight of a bluing dye. This layer has a thickness of about 3 to about 20 mils and is made using a cast tandem extrusion process with surface treatments (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.

[0033] Third floor This layer, located on the outside and in contact with the cheeks and tongue, consists of a transparent, high-temperature polymer and its blends—polysulfones (PSU, PES, PPSU)—plus 0.05% to 2% by weight of a bluing agent. This layer, with a thickness of approximately 3 to 20 mils, is produced using a cast-in-line extrusion process with surface treatments (corona, plasma, flame, and / or primer). It provides improved, low-creep applications for higher forces on the teeth.

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

[0035] First floor This layer, which contacts the teeth, comprises an aromatic polyether-based TPU with a Shore A hardness of approximately 80A; COPE; and SBC, an olefin-functional elastomer. This layer has a thickness of approximately 1 mil to 4 mils and is applied using either a tandem extrusion or full-coat roller coating process. This layer provides gripping traction and assists tooth movement.

[0036] Second floor This layer is a middle layer composed of a transparent, high-temperature polymer and its blends—polysulfone (PSU, PES, PPSU) plus 0.05-2% by weight of a bluing dye. This layer has a thickness of approximately 15 to 25 mils and is produced using a cast-in-line extrusion process with surface treatment (corona, plasma, flame, and / or primer). This layer provides improved structural application of forces associated with tooth / tooth movement and reduces creep / stress relaxation.

[0037] Third floor This layer, which contacts the cheeks and tongue, comprises an elastomer with a Shore A hardness of approximately 80A (aromatic polyether-based TPU); COPE; and SBC (olefin-functional elastomer). This layer has a thickness of approximately 1 mil to 4 mils and is applied using either a tandem extrusion or full-coat roller coating process. This layer provides a comfortable feel when in contact with the cheeks and tongue.

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

[0039] First floor This layer, which contacts the teeth, comprises amorphous (transparent) rigid copolyesters and blends thereof plus 0.05-2% by weight of a bluing dye. The layer has a thickness of about 3 to about 20 mils and is made using a cast-in-line 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.

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

[0041] Third floorThis layer, which contacts the cheeks and tongue, comprises a transparent, high-temperature polymer and its blends—polysulfones (PSU, PES, PPSU)—plus 0.05-2% by weight of a bluing dye. This layer, with a thickness of approximately 3 to 15 mils, is produced using a cast-in-line extrusion process with surface treatments (corona, plasma, flame, and / or primer). This layer provides structural application of forces for tooth / tooth movement and creep / stress relaxation reduction.

[0042] Figure 7 : This image 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, which adheres closely to the teeth, comprises amorphous (transparent) rigid copolyesters and blends thereof plus 0.05-2% by weight of a bluing dye. It is produced using a cast-in-line extrusion process with surface treatments (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, which contacts the cheek / tongue, comprises a transparent, high-temperature polymer and its blends—polysulfones (PSU, PES, PPSU)—plus 0.05-2% by weight of a bluing agent. This layer is produced using a cast-in-line extrusion process with surface treatment (corona, plasma, flame, and / or primer). This layer provides improved structural application of forces associated with 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, the inner layer that contacts the teeth, comprises an elastomer with a Shore hardness of approximately 80A—an aromatic polyether-based TPU; COPE; or an olefin-functional elastomer. This layer has a thickness of approximately 1 mil to 4 mils and is applied using either a tandem extrusion or full-coat roller coating process. This layer provides gripping traction to the teeth, aiding in movement and comfortable force application.

[0047] Second floor This layer, which contacts the cheek / tongue, comprises a transparent, high-temperature polymer and its blends—polysulfones (PSU, PES, PPSU)—plus 0.05-2% by weight of a bluing dye. This layer, with a thickness of approximately 15 to 25 mils, is produced using a cast-in-line extrusion process with surface treatments (corona, plasma, flame, and / or primer). This layer provides improved structural application of forces associated with tooth / tooth movement and greater reduction in creep / stress relaxation.

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

[0049] First floor This layer, which contacts the cheek / tongue, comprises a transparent, high-temperature polymer and its blends—polysulfones (PSU, PES, PPSU) plus 0.05-2% by weight of a bluing dye. This layer, with a thickness of approximately 3 to 15 mils, is produced using a cast-in-line extrusion process with surface treatment (corona, plasma, flame, and / or primer). It provides improved structural application of forces associated with 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 approximately 80A (aromatic polyether-based TPU); COPE; and SBC (olefin-functional elastomer). This layer has a thickness of approximately 1 mil to 15 mils and is produced using casting and coextrusion (for multi-layer soft core bonding). This layer helps bond the layers and comfortably transfers forces and strains from the outer rigid skin layer to the tooth / teeth, thereby reducing creep.

[0051] Third floor This layer, which contacts the tooth, comprises a transparent, high-temperature polymer and its blends—polysulfones (PSU, PES, PPSU) plus 0.05-2% by weight of a bluing dye. This layer, which is approximately 3 to 15 mils thick, is produced using a cast-in-line extrusion process with surface treatment (corona, plasma, flame, and / or primer). It provides improved structural application of forces associated with tooth movement and greater reduction in creep / stress relaxation.

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

[0053] First floor This layer, which contacts the cheek / tongue, comprises a transparent, high-temperature polymer and its blends—polysulfones (PSU, PES, PPSU)—plus 0.05-2% by weight of a bluing agent. This layer is produced using a cast-in-line extrusion process with a surface finish. It provides improved structural application of forces associated with tooth / tooth movement and greater reduction in creep / stress relaxation.

[0054] Second floor This layer, which comes into contact with the tooth / teeth, comprises amorphous (transparent) rigid copolyesters and their blends plus 0.05-2% by weight of a bluing dye. This layer is produced using cast extrusion and surface treatment (corona, plasma, flame, and / or primer). It offers a high-transparency, low-cost option. It also facilitates structural application of forces used for tooth / teeth movement and offers a low-creep option.

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

[0056] First floor This layer, approximately 1 to 8 mils thick and in contact with the cheek / tongue, comprises a transparent, high-temperature polymer and its blends—polysulfones (PSU, PES, PPSU)—plus 0.05-2% by weight of a bluing agent. This layer is produced using a cast extrusion and surface treatment process (corona, plasma, flame, and / or primer). It provides improved low-creep application with higher forces for tooth / tooth movement.

[0057] Second floor This layer, which is about 12 mils to about 25 mils thick, is a middle layer and comprises an amorphous (transparent) rigid copolyester and its blends plus about 0.05% to 2% by weight of a bluing dye. This layer is made using a cast tandem extrusion process. It provides improved, low-cost structural application for tooth / tooth movement forces, acts as a bonding layer for high-temperature layers, and offers enhanced thermoforming capabilities in the final application.

[0058] Third floor This layer, approximately 1 to 8 mils thick and in contact with the tooth, comprises a transparent, high-temperature polymer and its blends—polysulfones (PSU, PES, PPSU)—plus approximately 0.05-2% by weight of a bluing agent. This layer is produced using a cast extrusion and surface treatment process (corona, plasma, flame, and / or primer). It provides improved low-creep application with higher forces for tooth movement and, in combination with the first layer, forms a rigid "I" beam structure for optimized efficiency. DETAILED DESCRIPTION

[0059] In one embodiment, the present invention provides a dental brace comprising a component comprised 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 appliance having a total thickness of about 15 mils to about 30 mils. Another preferred embodiment provides a dental appliance having a modulus in the range of about 200,000 psi but less than about 500,000 psi and an applied initial force in the range of about 120 lbs to about 300 lbs.

[0061] Another embodiment provides a dental brace, wherein the dental brace material comprises an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases the active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances 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 having a Shore hardness of about 50A to about 60D, which is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copoly(ether or ester-ester), elastic copoly(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 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.

[0063] A preferred embodiment of this aspect of the invention provides a dental brace, wherein the outer soft layer comprises from 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 comprises from 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 comprises an active ingredient and / or 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 the active ingredient and / or 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 having 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; and the surface layer comprises a soft polymer having a Shore hardness of about 50A to about 60D, which is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copoly(ether or ester-ester), elastic copoly(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 comprises from 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 comprises from about 5% to about 25% of the total thickness of the dental brace. Another preferred embodiment provides a dental brace, wherein the core layer comprises a hard component made of a plastic material having a Rockwell R hardness greater than about 90 and less than about 110, and the soft surface layer has a Shore hardness greater than about 60A and less than about 50D.

[0066] Another preferred embodiment provides a dental appliance wherein the modulus of the dental appliance is about 200,000 psi but less than about 500,000 psi and the applied initial force is about 120 lbs but less than about 300 psi. Another preferred embodiment provides a dental appliance wherein the soft skin 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 comprises an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases the active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances dental treatment over a period of time.

[0068] Another aspect of the present invention provides a dental appliance 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] A preferred embodiment of this aspect of the invention provides a dental brace wherein the total thickness of the thermoplastic material is from about 15 mils to about 30 mils; the thermoplastic homopolymers and copolymers of polysulfone have an elastic modulus of 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 from about 10% but less than 200%; and wherein a monolayer based on the homopolymers and copolymers of polysulfone exhibits a stress relaxation in a 4% stress relaxation test at room temperature for 24 hours that 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 comprises an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases the active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances 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 that is 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), 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.

[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 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 the active ingredient and / or 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 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; and the surface layer comprises a soft thermoplastic polymer 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), 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.

[0074] A preferred embodiment provides a dental brace wherein the outer soft skin layer comprises from about 10% to about 30% of the total thickness of the dental brace. Another preferred embodiment provides a dental brace wherein the soft skin layer comprises from about 5% to about 25% of the total thickness of the dental brace. Another preferred embodiment provides a dental brace wherein the core layer comprises a rigid thermoplastic material having 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. 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.

[0075] Another preferred embodiment provides a dental brace, wherein the dental brace material comprises an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases the active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances 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 having a Shore hardness of about 50A to about 60D, the thermoplastic material being 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 surface 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.

[0077] One preferred embodiment provides a dental brace, wherein the dental brace material comprises an active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial, a tooth whitening agent, and an agent that enhances dental treatment. Another preferred embodiment provides a dental brace, wherein the dental brace material releases the active ingredient and / or therapeutic composition selected from an analgesic, an antibacterial, a tooth whitening agent, and another agent that enhances 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 that enables the force applied to the teeth to be adjusted 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 force applied by the material to the teeth is 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 gripping the teeth to apply the corrective force.

[0079] The present invention provides a dental brace that utilizes a specific polymer or combination of polymers and thicknesses 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 relatively hard, strong TPU, PETG, PC, polysulfone, or all hard segments, pure polymers or blends of hard TPU, and a soft material selected from soft thermoplastic elastic polyurethane, elastic polyester, polyamide, styrene block copolymer, TPV, EMA, EBA, and other TPEs, or pure polymers or blends of TPO. The soft component content of the dental brace is about 3% to about 50% of the total material of the dental brace.

[0081] Another embodiment of this aspect provides a dental brace constructed from a material having a Shore hardness of about 50D to about R100, 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 brace having a total thickness of about 30 mils. Another preferred embodiment provides a dental brace constructed from 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 present invention provides a dental brace comprising two layers of comfortable plastic. One embodiment of this aspect provides a dental brace comprising an inner or base layer made of a strong, hard plastic, such as PETG, PC, polysulfone, or TPU, which provides the "working" portion of the plastic piece that moves the teeth. A surface or outer layer comprising a soft polymer, such as TPU, TPE, an elastomeric copolyester, EMA, or EBA, provides a comfortable layer on top of the hard base layer and is able to effectively conform to the tooth surface contours and transmit tooth-moving forces.

[0084] Another embodiment of this aspect provides a dental appliance, wherein the soft surface layer comprises about 3% to about 20% of the total thickness of the dental appliance. Another embodiment provides a dental appliance, wherein the soft surface layer has a Shore hardness in the range of about 40A to about 50D. Another preferred embodiment provides a dental appliance composed of a material having 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 present invention provides a dental brace having more than two layers of comfortable 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, or TPU, 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, or EBA, which provides a comfortable layer and force transfer from the hard base layer.

[0086] Another embodiment of this aspect provides a dental appliance, wherein the outer soft surface layer comprises about 3% to about 30% of the total thickness of the dental appliance. Another embodiment provides a dental appliance, wherein the soft surface layer has a Shore hardness in the range of about 40A to about 50D. Another preferred embodiment provides a dental appliance, 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 orthodontic devices that are 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 herein.

[0091] As used herein, the term "plastic material" refers to a material used to manufacture dental braces. An example of a plastic material is a resilient thermoplastic, which, when used to manufacture dental braces, helps to apply pressure to the teeth / teeth to move the teeth into 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 created 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 elastic modulus 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 outside of the dental brace, which is usually softer than the layers it is wrapped around, and is the part that comes in direct contact with the teeth / teeth, as well as the tongue and 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 typically completely encased in a generally softer outer layer. Illustrative examples include Figure 1 As shown in Part B.

[0097] As used herein, the term "strong component" refers to the internal component described above. An illustrative example of a strong component is a plastic material having a Shore hardness 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 a tooth when the dental brace is placed on top of the tooth. This initial force is related to the type of material used to construct the dental brace.

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

[0101] As used herein, the term "antimicrobial agent" refers to a group of materials that act against pathogenic bacteria. Thus, 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 plaque-related diseases such as dental caries. However, it should be noted that antimicrobial agents do not necessarily have anti-plaque accumulation properties. Illustrative examples of antimicrobial 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 remove stains or other discolorations from 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 held together by intermolecular forces that rapidly weaken as the temperature rises, producing a viscous liquid. In this state, thermoplastics can be reshaped and are commonly used to produce parts using various polymer processing techniques such as injection molding, compression molding, calendering, and extrusion. Thermoplastics are distinguished from thermosetting polymers (or "thermosets"), which form irreversible chemical bonds during the curing process. Thermosets do not melt when heated, but typically decompose upon cooling and do not reform.

[0104] As used herein, the term "Rockwell R hardness" indicates the hardness of a material by measuring the depth of penetration of an indenter under a large load compared to the compression produced by a preload. Different scales, designated by a single letter, exist, using different loads or indenters. The result is a dimensionless number. The indenter can be a diamond tip, steel, or a tungsten carbide ball. The Rockwell test procedures used in the plastics industry are ASTM D785 and ISO 2039-2, and are summarized at 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 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 types of polysulfone are used industrially: polysulfone (PSU), polyethersulfone (PES), and polyphenylsulfone (PPSU). They can be used in temperatures ranging from -100 to +200°C and are used in electrical equipment, vehicle construction, and medical technology. They consist of para-linked aromatic hydrocarbons, sulfonyl and ether groups, and some alkyl groups. As described at https: / / en.wikipedia.org / wiki / Polysulfone, polysulfones exhibit excellent thermal and oxidative 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 shown below:

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

[0109] PSU:YOUJU XIN CAI Paryls 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 SI unit of pressure or force, multiplied by x1,000,000. As explained at https: / / en.wikipedia.org / wiki / Pascal_(unit), 1 MPa 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 change in length after a specimen breaks to its initial length in a tensile test. It indicates the ability of a material to resist a change in shape without cracking, as described in https: / / www.wikidata.org / wiki / Property:P5811.

[0136] Example:

[0137] The dental braces of the present invention include the soft component / layer / surface and the 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 three-layered dental brace, wherein the soft component is approximately 3 mils thick and the hard component is approximately 24 mils thick. Two 3-mil soft layers are located 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 located on opposite sides of the brace (one in direct contact with the teeth and the other 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 layer.

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

[0140] Three-layer braces:

[0141]

[0142]

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

[0144] Example 2 - Multi-layer 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, the other in direct contact with the inside of the cheek and tongue). Details of the hard / rigid and soft layers / assemblies are as follows. The thickness of each layer in this embodiment is approximately 10 mils.

[0145] One or more hard layers:

[0146]

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

[0148] Two layers:

[0149]

[0150] Example 4 - Single / Single-layer appliance: The following examples 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 - Multi-layer high temperature hybrid dental appliance The following example illustrates a multi-layer dental appliance made of three layers. The first layer is about 5 to 20 mils thick and comes into contact with the teeth when placed in the mouth. It is made of an amorphous, transparent, rigid copolyester and blends thereof with about 0.05% to about 2% by weight of a bluing agent. 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, a COPE (copolyetherester), an olefin-functional elastomer, and a 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% by weight of a bluing agent.

[0154] One or more hard mixed 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 aromatic polyether-based TPU or copolyetherester or olefin functional elastomer, and the inner layer (also called the core layer) is selected from polysulfone (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 "external stretch" surface layer) is selected from a hard material based on polysulfone homopolymers and copolymers 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) at a lower thickness to the teeth, thereby helping to reduce the overall time required to move the teeth, reducing pain, and may help reduce the need for mid-range corrections. In some cases, it may also reduce the total 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 will 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. Unless otherwise noted, all samples are 30 mil thick.

[0176] result : Force / load (1bf) values ​​are reported at the time intervals specified in the table below.

[0177] Table I

[0178] Table I is based on initial load ( lbf Sorting

[0179]

[0180] Table I Table 1 lists the stress relaxation of dental braces made of 30-mil single-layer PSU, TPU (control), PETG A, and PETG B. Also included are a three-layer brace with a soft, 85A durometer skin layer and a 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 skin layer and a soft, 34-mil, 85A TPU core layer; a two-layer brace with a PSU base and an 85A TPU skin layer; and a commercially available brace with a hard skin layer and a soft core layer. The column labeled "0" is time zero and shows the starting force at time zero and the force loss over time, with intervals ranging from a quarter hour, half an hour, three quarter hours, 1, 2, 3, and finally 72 hours.

[0181] Figure I

[0182]

[0183] Figure I Figure 1 depicts the stress loss curves over time for each of the braces in Table 1. Initial stress is plotted along the Y-axis and stress loss along the X-axis, from left to right.

[0184] Table II

[0185] Table II: Sorted by Minimum Percentage of Stress Loss

[0186]

[0187] Table IITable II lists the stress relaxation of dental braces made of 30-mil single-layer PSU, TPU (control), PETG A, and PETG B, respectively. Also included are a three-layer brace with a soft, 85A durometer skin layer and a rigid core layer of PETG B; a 19-mil single-layer brace made of PSU; a three-layer brace with a rigid PSU skin layer and a 34-mil, 85A TPU soft core layer; a two-layer brace with a PSU base and an 85A TPU skin layer; and a commercially available brace with a hard skin layer and a soft core layer. The column marked "0" is time zero and shows the starting force at time zero and the force loss over time, with intervals of 15 minutes, 30 minutes, 1, 2, 3, and so on, to 72 hours.

[0188] Figure / Chart II

[0189]

[0190] Figure / Chart II Figure II shows the retained stresses for the braces listed in Table II. The brace with the smallest stress loss is on the left.

[0191] Table III

[0192] The area under the curve was calculated after the 4% SR test was performed. Seventy-two hour values ​​are reported in Table III below.

[0193]

[0194] Table III Table III lists the areas under the curves calculated after 4% stress relaxation testing (72 hours) for 30-mil-thick single-layer PSU, TPU (control), PETG A, and PETG B dental appliances. These include a three-layer appliance with a soft, 85A durometer skin layer and a rigid, central core layer of PETG B; a 19-mil-thick single-layer appliance made of PSU; a three-layer appliance with a rigid PSU skin layer and a 34-mil, 85A TPU soft core layer; a two-layer appliance with a PSU base and an 85A TPU skin layer; and a commercially available appliance with a hard skin layer and a soft core layer. Larger area under the curve values ​​indicate greater work done by the material and structure, or the cumulative amount of force applied to move a tooth over 72 hours.

[0195] Figure / Chart III

[0196]

[0197] Figure / Graph III shows the area under the curve for the orthotics listed in Table III.

Claims

1. A dental brace comprising a first soft layer for contacting the teeth of a subject after the brace is worn on the teeth of the subject and a second hard layer sandwiched between two first layers, the second layer not contacting the teeth of the subject, wherein: The dental brace is one of several dental braces used in the orthodontic treatment plan of the subject, so as to move the teeth of the subject to the corrected tooth position by using several dental braces over a period of time, and the dental brace comprises: a first layer, wherein the first layer is configured to provide a softer, more comfortable layer against the subject's teeth than the second layer, the first layer comprising a first transparent thermoplastic material having a Shore hardness of 50A to 60D, wherein the first transparent thermoplastic material is selected from the group consisting of thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastomeric co-(ether or ester-ester), elastomeric co-(ether or ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA), and combinations thereof, wherein the transparent material is light transmissive when viewed from the subject's teeth; and a second layer, wherein the second layer is harder than the first layer and comprises a second transparent thermoplastic material having a Rockwell R hardness greater than 60 and less than 115, wherein the second transparent thermoplastic material is selected from the family of homopolymers and copolymers of polysulfones and blends thereof, and combinations thereof, wherein the second layer is used to provide a tooth-moving force to move a tooth of a subject, and the transparent material is light-transmissive when viewed from the subject's tooth; The softer first soft layer accounts for 10% to 20% of the total thickness of the dental braces; wherein a softer first layer is used to provide a more compliant comfort to the subject and less pain to the subject when a plurality of dental braces are worn on the teeth of a subject over a period of time when against the teeth, as compared to the compliant comfort and pain caused when a single hard layer dental brace without a softer first layer is worn on the teeth of the subject over a period of time; wherein the combined first and second layers of transparent material are used to provide a transparent, light-transmissive dental brace when the dental brace is worn on the teeth of a subject; wherein the dental appliance, when worn on the teeth of a subject, has an initial modulus of 200,000 psi and less than 500,000 psi and an initial force applied on at least one tooth of the subject of 120 lbs and less than 300 lbs; and Among them, the transparent material is made by a casting tandem extrusion process, including surface treatment processes, corona, plasma, flame or primer.

2. A dental brace comprising a first soft layer for contacting the teeth of a subject after the brace is worn on the teeth of the subject and a second hard layer sandwiched between two first layers, the second hard layer not contacting the teeth of the subject, wherein: The dental brace is one of several dental braces used in an orthodontic treatment plan for a subject to move the teeth of the subject to a corrected tooth position over a period of time, the dental brace comprising at least two layers of material, including a second layer not in contact with the teeth of the subject, and a first layer for contacting the teeth of the subject, wherein: The first layer comprises a first polymer having a Shore hardness of 60A to 50D selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastomeric copolyester, elastomeric copoly(ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA), and combinations thereof; The second layer has a hard component made of a plastic material having a Rockwell R hardness greater than 90 and less than 110, wherein the plastic material comprises a transparent plastic material selected from polyethylene terephthalate glycol (PETG), rigid thermoplastic polyurethane (r-TPU), polysulfone, and combinations thereof; and wherein the second layer and the first layer having a transparent material are used to provide a transparent, light-transmissive dental appliance when the dental appliance is worn on the teeth of a subject; Among them, the first layer accounts for 10% to 25% of the total thickness of the dental braces; wherein a softer first layer is used to provide a more compliant comfort to the subject and less pain to the subject when a plurality of dental braces are worn on the teeth of a subject over a period of time when against the teeth, as compared to the compliant comfort and pain caused when a single hard layer dental brace without a softer first layer is worn on the teeth of the subject over a period of time; wherein the modulus of the dental appliance is 200,000 psi but less than 500,000 psi and the initial force applied is 120 lbs but less than 300 psi; and Among them, the transparent material is made by a casting tandem extrusion process, including surface treatment processes, corona, plasma, flame or primer.

3. A dental brace comprising a first soft layer and a second hard layer, wherein the first layer is used to contact the teeth of the subject after the brace is worn on the teeth of the subject, and the second hard layer is sandwiched between the two first layers, and the second hard layer does not contact the teeth of the subject, wherein: The dental brace is one of several dental braces used in an orthodontic treatment plan for a subject to move the subject's teeth into corrected tooth positions over a period of time, wherein: The first layer is close to the teeth and is softer than the second layer, and is composed of a thermoplastic material with a Shore hardness of 50A to 60D, and the thermoplastic material is selected from thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV), elastic copolyester, elastic copoly (ester-amide), copolymer ethylene-methyl acrylate (EMA) or ethylene-butyl acrylate (EBA) and combinations thereof; The second layer is hard and comprises a transparent thermoplastic material having a Rockwell R hardness greater than 60 and less than 110, wherein the thermoplastic material is selected from the family of homopolymers and copolymers of polysulfone and blends thereof; wherein the transparent material and the first soft layer are used to provide a transparent, light-transmissive dental brace when the dental brace is worn on the teeth of a subject; wherein the softer first layer is used to provide a more compliant comfort to the subject and less pain to the subject when a plurality of dental braces are worn on the teeth of the subject over a period of time, when the braces are worn against the teeth of the subject, as compared to the compliant comfort and pain caused when a single hard layer dental brace without the softer first layer is worn on the teeth of the subject over a period of time; and Among them, the transparent material is made by a casting tandem extrusion process, including surface treatment processes, corona, plasma, flame or primer.

4. The dental brace according to claim 3, wherein: The first soft layer accounts for 10% to 20% of the total thickness of the dental braces.

5. The dental brace according to claim 4, wherein: The first soft layer accounts for 5% to 15% of the total thickness of the dental appliance.

6. The dental brace according to claim 5, wherein: When the dental brace is worn on the teeth of a subject, the initial modulus of the dental brace is in the range of 200,000 psi to 500,000 psi, and the initial force that can be applied to at least one tooth of the subject is in the range of 120 lbs to 300 lbs.

7. The dental brace according to claim 3, wherein: The first soft layer comprises an active ingredient and / or therapeutic composition selected from the group consisting of analgesics, antibacterial agents, tooth whitening agents, and agents that enhance dental treatment.

8. The dental brace according to claim 1, wherein: The first layer having the first transparent material is used to improve the creep reduction effect of the dental brace compared to a dental brace without the first layer and without the first transparent material.

9. The dental brace according to claim 1, in, The first soft layer, when in close contact with the teeth, is used to provide a more compliant feeling of comfort to the subject and cause less pain to the subject when the dental brace is worn on the teeth of the subject, compared to the compliant feeling of comfort and pain caused when a hard layer dental brace without the first soft layer is worn on the teeth of the subject; as well as Among them, the first soft layer close to the teeth is used to provide 1a) more effective force transmission to the subject's teeth, 2a) shorter time required to move the subject's teeth, 3a) fewer number of dental braces required to move the subject's teeth when orthodontic treatment is carried out on the subject, and 4b) improved creep of the dental braces, compared with 1b) force transmission to the subject's teeth by a dental brace without a first soft layer, 2b) time required for the dental brace without a first soft layer to move the subject's teeth, 3b) number of dental braces without a first soft layer required to move the subject's teeth when orthodontic treatment is carried out on the subject, and 4b) amount of creep caused by the dental brace without a first soft layer worn on the subject's teeth.

10. The dental brace of claim 1, wherein: The total thickness of the dental braces shall not exceed 20 mils (0.508 mm).

11. The dental brace according to claim 1, wherein: The stress relaxation of the dental braces under ambient conditions within 24 hours is less than 30%.

12. The dental brace of claim 1, wherein: The dental braces are capable of exerting over 35,000,000 forces on the subject's teeth, measured based on the stress relaxation curve of the brace structure over a 24-hour period over a total area at a thickness of 20 mils (0.508 mm), to maintain greater than 65% of the tooth movement force on the teeth while subject to strains up to 4% over a 24-hour period without causing the dental brace to fracture.

13. The dental brace of claim 1, wherein: The second layer has a Shore D hardness of at least R100.

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