Correcting appliance for tooth orthodontics and correcting appliance diaphragm

Abstract

The invention provides an orthodontic appliance for tooth orthodontics and an orthodontic appliance diaphragm. The appliance comprises a shell and a cavity, the shell comprises a wrapping layer and a structural layer, the structural layer is located outside the wrapping layer, the wrapping layer is used for wrapping teeth, the inner surface of the wrapping layer makes contact with the teeth, and the overall size of the cavity is smaller than that of the teeth. According to the orthodontic appliance, the phenomena of slipping and sleeve disengaging do not easily occur between the orthodontic appliance and teeth, the control effect on a tooth axis can be improved, the orthodontic force and torque applying capacity of the orthodontic appliance can be further improved, and meanwhile the orthodontic appliance can also have excellent elongation at break and tearing strength.

Description

Technical Field

[0001] The invention relates to an appliance and an appliance membrane for orthodontics. Background Art

[0002] When invisible braces are used to treat malocclusion, a series of braces with cavities that are consistent with the patient's jaw shape are formed by hot pressing using polymer film materials. The design position of each brace cavity is closer to the target position than the initial jaw position and the previous brace. When in use, the brace cavity wraps around the patient's jaw, and the deviation between the design position and the jaw position causes the brace to undergo elastic deformation, thereby generating a corrective force that moves the teeth to the target position. It can be said that the ability to apply corrective force and torque is the most critical factor in the effectiveness of invisible braces, but current invisible braces still have several deficiencies: (1) Since the shape of the brace cavity is consistent with the shape of the teeth, and the brace can only interact with the teeth through contact and compression (i.e., it can only generate pressure, not tension), when the shape of the teeth is relatively smooth, such as for canines and premolars, it is easy for the brace to slip and come off the teeth, thereby limiting the brace to apply corrective force and torque to the teeth. (2) The area of ​​the appliance corresponding to the tooth neck is closer to the impedance center of the tooth, so the force-applying ability of this area plays a key role in the control of the tooth axis. However, because this area is close to the opening of the appliance cavity, it has weaker rigidity and is more likely to deform after being subjected to force, which makes it easier to create gaps between the teeth or cause slippage, affecting the appliance's control over the tooth axis. (3) In order to assist the appliance in applying force, clinical practice generally involves bonding accessories made of light-curing resin materials to the teeth. Since accessories are smaller in size than teeth, they are more affected by the machining accuracy of the appliance. In actual applications, gaps are easily created between the accessory cavity corresponding to the appliance, greatly affecting the effectiveness of the appliance. Summary of the invention

[0003] In order to solve the problem of poor correction force and torque application ability of the orthodontic appliance in the prior art, an orthodontic appliance and an orthodontic appliance membrane are provided. The orthodontic appliance is not prone to slippage and disengagement from the tooth, can improve the control effect on the tooth axis, further improve its correction force and torque application ability, and at the same time, the orthodontic appliance can also have excellent elongation at break and tear strength.

[0004] The present invention mainly adopts the following technical solutions to solve the above technical problems:

[0005] The present invention provides an orthodontic appliance, comprising a shell and a cavity, wherein the shell comprises a wrapping layer and a structural layer, wherein the structural layer is located outside the wrapping layer, and the wrapping layer is used to wrap teeth, wherein the inner surface of the wrapping layer contacts the teeth, and is characterized in that the overall size of the cavity is smaller than the size of the teeth.

[0006] The present invention provides a soft material layer on the inner surface of the brace, and the inner surface size of the cavity where the brace wraps the teeth is smaller than the surface size of the teeth, so that all-round extrusion of the brace and the teeth is formed when the brace is worn, thereby forming a pre-tightening pressure. This pre-tightening pressure allows the wrapping layer to fit the teeth fully, eliminating gaps caused by deformation and process deviations. At the same time, the normal force between the inner surface of the brace and the teeth increases, and the friction between the two is also increased. This pre-tightening pressure allows the interaction between the brace and the teeth to be more complete; at the same time, the increased friction between the two can also form a greater combined force and combined torque on the teeth, thereby enhancing the control over the teeth. Together with the increased wrapping and friction, the brace is less likely to come off relative to the jaw when the tooth movement deviates from the design.

[0007] In the present invention, the cavity is a space formed by the inner surface of the wrapping layer, the overall size of the cavity means the volume of the cavity, and the size of the tooth means the volume of the tooth.

[0008] The structural layer in the present invention can be used to provide structural support for the orthodontic appliance and provide resilience when the orthodontic appliance is deformed.

[0009] In the present invention, the elastic modulus of the structural layer and the wrapping layer is preferably (5-2.5×10 6 ): 1, more preferably (5-2.5×10 3 ): 1, and more preferably (5-2.5×10 2 ):1, for example 100:1.

[0010] In the present invention, the thickness ratio of the structural layer to the wrapping layer is preferably (1-20):1, more preferably (1-15):1, and further preferably (1-10):1, for example, 6:1.

[0011] In the present invention, the elastic modulus of the wrapping layer is preferably 0.001-200 MPa, more preferably 0.001-10 MPa.

[0012] In the present invention, the elastic modulus of the structural layer is preferably 500-2500 MPa, more preferably 700-1600 MPa, for example 1000 MPa.

[0013] In the present invention, the thickness of the wrapping layer is preferably 0.005-0.5 mm, more preferably 0.005-0.3 mm, for example 0.143 mm.

[0014] In the present invention, the thickness of the structural layer is preferably 0.2-1.2 mm, more preferably 0.3-0.6 mm, for example 0.5 mm.

[0015] In the present invention, the size deviation of the cavity is preferably 0.01%-20%, for example 5% or 7%. The size deviation means the percentage of the volume difference between the tooth and the cavity to the volume of the cavity.

[0016] Preferably, the size deviation of the cavity at different positions is different; more preferably, the size deviation of the cavity at the crown far from the gum is smaller than the size deviation at the crown near the gum. The crown far from the gum refers to the upper half of the tooth, and the crown near the gum refers to the lower half of the tooth.

[0017] Wherein, the size deviation of the cavity at the crown away from the gum is preferably 0.1%-3%.

[0018] Wherein, the size deviation of the cavity at the crown close to the gum is preferably 6%-15%.

[0019] In the present invention, the interior of the wrapping layer preferably contains closed cells, and the shape of the closed cells is preferably spherical, rod-shaped or irregular.

[0020] In the present invention, the interior of the wrapping layer preferably contains a frame structure, and the frame structure is preferably a micro-column structure, an X-shaped frame structure or a micro-honeycomb structure.

[0021] In the present invention, the material of the wrapping layer preferably includes one or more of PA, PETG, TPU, PC, TPE, EVA, TPV and hydrogel.

[0022] In the present invention, the material of the structural layer preferably includes one or more of PA, PETG, TPU, PC, TPE, EVA and TPV.

[0023] In the present invention, the inner surface of the wrapping layer is preferably provided with protrusions and / or grooves, and the shapes of the protrusions and / or grooves are, for example, dot-shaped, strip-shaped or circle-shaped.

[0024] In the present invention, the structural layer is a single-layer structure or a multi-layer structure; when the structural layer is a multi-layer structure, the structural layer includes N1 sub-layers, N1≥2; wherein the elastic modulus of the N1 sub-layers preferably shows a gradient decreasing trend along the direction approaching the teeth, and the gradient is preferably 0.01-10MPa / um.

[0025] Among them, when N1 is 2, the elastic modulus of the two sublayers along the direction close to the teeth is preferably (1-5):1.

[0026] In the present invention, the wrapping layer is a single-layer structure or a multi-layer structure; when the wrapping layer is a multi-layer structure, the wrapping layer includes N2 sub-layers, N2≥2; wherein the elastic modulus of the N2 sub-layers preferably shows a gradient decreasing trend along the direction approaching the teeth, and the gradient is preferably 0.01-40MPa / um.

[0027] Among them, when N2 is 2, the elastic modulus of the two sublayers along the direction close to the teeth is preferably (1-30):1.

[0028] In the present invention, when the structural layer and the wrapping layer are respectively configured as a multi-layer structure, the comfort of the orthodontic appliance can be improved, and the auxiliary functions of the structural layer can also be increased.

[0029] In the present invention, the preparation method of the brace preferably adopts a hot pressing film forming process, for example, it may include the following steps: compression molding the heated wrapping layer material and the structural layer material, and sequentially cooling, cutting, and post-processing to form the wrapping layer and the structural layer of the brace, respectively, to obtain the brace.

[0030] The present invention also provides a corrector diaphragm, which comprises a wrapping layer and a structural layer, wherein the elastic modulus ratio of the structural layer to the wrapping layer is (5-2.5×10 6 ):1; the thickness ratio of the structural layer to the wrapping layer is (1-20):1.

[0031] On the basis of being in accordance with the common sense in the art, the above-mentioned preferred conditions can be arbitrarily combined to obtain the preferred embodiments of the present invention.

[0032] The reagents and raw materials used in the present invention are commercially available.

[0033] The positive and progressive effects of the present invention are:

[0034] The present invention provides a wrapping layer on the inner surface of the brace, and the inner surface size of the cavity of the brace wrapping the teeth is smaller than the surface size of the teeth, so that a pre-tightening pressure can be formed between the brace and the teeth, and the correction force of the brace is improved at the same time, and the brace is not easy to fall off during use.

[0035] The orthodontic appliance of the present invention also has excellent elongation at break and tear strength, and has a long service life. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 Schematic diagram of the structure of the orthodontic device of Examples 1-6.

[0037] Figure 2 Schematic diagram of the structure of the encapsulation layer containing a micro-pillar structure.

[0038] Figure 3It is a schematic diagram of the structure of the wrapping layer containing an X-shaped frame structure.

[0039] Figure 4 Schematic diagram of the structure of the encapsulation layer containing a micro-honeycomb structure.

[0040] Figure 5 Schematic diagram of the structure of the encapsulation layer containing spherical closed cells.

[0041] Figure 6 Schematic diagram of the structure of the encapsulation layer containing rod-shaped closed pores.

[0042] Figure 7 Schematic diagram of the structure of the wrapping layer containing irregularly shaped closed cells.

[0043] Figure 8 Schematic diagram of the structure of teeth containing the orthodontic device of Examples 1-6.

[0044] Fig. 9 Schematic diagram of the orthodontic force generated by teeth containing the orthodontic appliances of Examples 1-6.

[0045] Fig.10 Schematic diagram of the structure of teeth containing the orthodontic appliance of Comparative Example 1.

[0046] The reference numerals are as follows:

[0047] 1-wrapping layer; 101-micro-pillar structure; 102-X-shaped frame structure; 103-micro-honeycomb structure; 104-spherical closed cells; 105-rod-shaped closed cells; 106-irregular shaped closed cells; 2-structural layer; 3-tooth surface; 4-orthodontic appliance. DETAILED DESCRIPTION

[0048] The present invention is further described below by way of examples, but the present invention is not limited to the scope of the examples. The experimental methods in the following examples without specifying specific conditions are carried out according to conventional methods and conditions, or selected according to the product specifications.

[0049] Examples 1-6

[0050] The orthodontic appliances of Examples 1-6 adopt a hot pressing film forming process based on a dental model, specifically as follows: the heated hydrogel and PA are compression molded on the dental mold, and are successively cooled, cut, and post-processed to form a wrapping layer and a structural layer of the orthodontic appliance, thereby obtaining the orthodontic appliance.

[0051] The orthodontic appliance of embodiments 1-6 comprises a shell and a cavity, such as Figure 1 The schematic diagram of its application on teeth is shown in Figure 8 and 9The shell of the orthodontic appliance 4 of Examples 1-6 includes a wrapping layer 1 and a structural layer 2, wherein the structural layer 2 is located outside the wrapping layer 1, and the wrapping layer 1 is used to wrap the tooth 3, and the inner surface of the wrapping layer 1 is in contact with the tooth 3, and the overall size of the cavity is smaller than the size of the tooth surface 3. The interior of the wrapping layer 1 of Examples 1-3 contains spherical closed cells 104, rod-shaped closed cells 105, and irregular-shaped closed cells 106, respectively, as shown in FIG. Figure 5 , Figure 6 and Figure 7 As shown; the interior of the wrapping layer 1 of Examples 4-6 respectively contains a micro-pillar structure 101, an X-shaped frame structure 102 and a micro-honeycomb structure 103, respectively as shown Figure 2 , 3 and 4.

[0052] Among them, the inner surface of the wrapping layer of Examples 1-6 is provided with protrusions and grooves, and the shapes of the protrusions and grooves are both point-shaped.

[0053] During the use of Examples 1-6, a correction force will be formed, such as Fig. 9 As shown, L is the direction of tooth elongation and H is the direction of corrective force.

[0054] The parameters of the wrapping layer and the structural layer of Examples 1-6 are listed in Table 1 below:

[0055] Table 1

[0056]

[0057] Note: “ / ” in the table means not included.

[0058] The dimensional deviation parameters of Examples 1-6 are listed in Table 2 below:

[0059] Table 2

[0060]

[0061] Note: “ / ” in the table means not included.

[0062] Among them, the elastic modulus of the two sublayers of the structural layer of Example 6 shows a gradient decreasing trend along the direction close to the teeth, with a gradient of 5 MPa / um, and an elastic modulus ratio of 2.5:1; the elastic modulus of the two sublayers of the wrapping layer of Example 6 shows a gradient decreasing trend along the direction close to the teeth, with a gradient of 20 MPa / um, and an elastic modulus ratio of 15:1.

[0063] Comparative Example 1

[0064] The parameters of the wrapping layer and the structural layer of the orthodontic appliance of Comparative Example 1 are listed in Table 1, and the dimensional deviation parameters of the orthodontic appliance of Comparative Example 1 are listed in Table 2.

[0065] During the use of Comparative Example 1, no correction force can be formed. Fig.10 shown.

[0066] Comparative Example 2

[0067] Comparative Example 2 contains only one structural layer. The parameters of the braces wrapping layer and the structural layer of Comparative Example 2 are listed in Table 1. The size deviation parameters of the braces of Comparative Example 2 are listed in Table 2.

[0068] Effect Example 1

[0069] Elongation at break test: The tensile toughness test was performed on the orthodontic appliances of Examples 1-6 and Comparative Examples 1 and 2, and the test method was in accordance with the method of "GB / T 1040.3 2006 Determination of tensile properties of plastics", and the equipment tensile speed was set to 50 mm / min. Type 5 specimens were used.

[0070] Tear strength test: The tear strength test was carried out on the orthodontic appliances of Examples 1-6 and Comparative Examples 1 and 2. The test method was in accordance with Method B and Experimental Procedure (a) of GB / T 529-2008 Determination of Tear Strength of Vulcanized Rubber or Thermoplastic Rubber, wherein the sample was prepared in accordance with 5.1.2 of the standard, the sample thickness was based on the actual thickness of the product, and the tensile speed was 200±10 mm / min.

[0071] The test results are shown in Table 3 below:

[0072] Table 3

[0073]

[0074] From the above table data, it can be seen that the orthodontic appliances of Examples 1-6 can have excellent correction force, preload force, elongation at break and tear strength. The elongation at break of Examples 1-6 can reach more than 90%, and the tear strength can reach more than 149 kN / m.

[0075] Compared with Example 1, the elastic modulus of the structural layer and the wrapping layer of Comparative Example 1 is relatively low, which makes the correction force of the orthodontic appliance of Comparative Example 1 significantly worse. At the same time, the tear strength is reduced from 161 kN / m to 129 kN / m, which is not conducive to the control of the orthodontic appliance on the tooth axis and the service life of the orthodontic appliance.

[0076] Compared with Example 1, Comparative Example 2 only includes a structural layer, so that it cannot form a preload, and the elongation at break is significantly reduced from 102% to 75%. Comparative Example 2 cannot form a preload, so that the brace and the tooth fit poorly, and the gap caused by deformation and process deviation cannot be eliminated, so that the interaction between the two is insufficient, affecting the brace control of the tooth axis.

Claims

1. An appliance for orthodontics, comprising a shell and a cavity, wherein the shell comprises a wrapping layer and a structural layer, wherein the structural layer is located outside the wrapping layer, the wrapping layer is used to wrap teeth, and the inner surface of the wrapping layer is in contact with the teeth, characterized in that: The overall size of the cavity is smaller than the size of the tooth.

2. The orthodontic appliance according to claim 1, characterized in that: The elastic modulus ratio of the structural layer to the wrapping layer is (5-2.5×10 6 ): 1, preferably (5-2.5×10 3 ): 1, more preferably (5-2.5×10 2 ):1, for example, 100:1; And / or, the thickness ratio of the structural layer to the wrapping layer is (1-20):1, preferably (1-15):1, more preferably (1-10):1, for example 6:

1.

3. The orthodontic appliance according to claim 1, characterized in that: The elastic modulus of the wrapping layer is 0.001-200 MPa, preferably 0.001-10 MPa; And / or, the elastic modulus of the structural layer is 500-2500 MPa, preferably 700-1600 MPa, for example 1000 MPa.

4. The orthodontic appliance according to claim 1, characterized in that: The thickness of the wrapping layer is 0.005-0.5 mm, preferably 0.005-0.3 mm, for example 0.143 mm; And / or, the thickness of the structural layer is 0.2-1.2 mm, preferably 0.3-0.6 mm, for example 0.5 mm.

5. The orthodontic appliance according to claim 1, characterized in that: The size deviation of the cavity is 0.01%-20%, for example, 5% or 7%; wherein the size deviation means the percentage of the volume difference between the tooth and the cavity to the volume of the cavity; Preferably, the size deviation of the cavity at different positions is different; more preferably, the size deviation of the cavity at the crown away from the gum is smaller than the size deviation at the crown close to the gum; wherein the crown away from the gum refers to the upper half of the tooth, and the crown close to the gum refers to the lower half of the tooth; wherein the size deviation of the cavity at the crown away from the gum is preferably 0.1%-3%; the size deviation of the cavity at the crown close to the gum is preferably 6%-15%.

6. The orthodontic appliance according to claim 1, characterized in that: The interior of the wrapping layer contains closed cells, and the shape of the closed cells is preferably spherical, rod-shaped or irregular; And / or, the interior of the wrapping layer contains a frame structure, and the frame structure is preferably a micro-column structure, an X-shaped frame structure or a micro-honeycomb structure; And / or, the inner surface of the wrapping layer is provided with protrusions and / or grooves, and the shapes of the protrusions and / or grooves are, for example, dot-shaped, strip-shaped or circle-shaped.

7. The orthodontic appliance according to claim 1, characterized in that: The structural layer is a single-layer structure or a multi-layer structure; When the structural layer is a multi-layer structure, the structural layer includes N1 sub-layers, N1≥2; wherein the elastic modulus of the N1 sub-layers preferably decreases gradually along the direction close to the teeth, and the gradient is preferably 0.01-10 MPa / um; Among them, when N1 is 2, the elastic modulus of the two sublayers along the direction close to the teeth is preferably (1-5):

1.

8. The orthodontic appliance according to claim 1, characterized in that: The wrapping layer is a single-layer structure or a multi-layer structure; When the wrapping layer is a multi-layer structure, the wrapping layer includes N2 sub-layers, N2≥2; wherein the elastic modulus of the N2 sub-layers preferably decreases gradually along the direction close to the teeth, and the gradient is preferably 0.01-40 MPa / um; Among them, when N2 is 2, the elastic modulus of the two sublayers along the direction close to the teeth is preferably (1-30):

1.

9. The orthodontic appliance according to claim 1, characterized in that: The material of the wrapping layer includes one or more of PA, PETG, TPU, PC, TPE, EVA, TPV and hydrogel; And / or, the material of the structural layer includes one or more of PA, PETG, TPU, PC, TPE, EVA and TPV.

10. A corrective device membrane, characterized in that: It includes a wrapping layer and a structural layer, wherein the elastic modulus ratio of the structural layer to the wrapping layer is (5-2.5×10 6 ):1; the thickness ratio of the structural layer to the wrapping layer is (1-20):1.

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