Mold for manufacturing oral appliance, design method of mold, mold combination and manufacturing method of oral appliance

Abstract

The invention provides a mold for manufacturing an oral appliance, a design method of the mold, a mold combination and a manufacturing method of the oral appliance, and the mold comprises a first forming part used for constructing a first cavity space matched with a first part of the oral appliance in shape, wherein the first part is a part suitable for oral cavity internal structures of different users or different wearing stages; the second forming part is made of a sheet-shaped elastic material which is softer than the first forming part and is used for constructing a second cavity space matched with the shape of a second part, except the first part, of the oral appliance; the attachment part is made of a material harder than the second forming part, and the face, facing the oral appliance, of the attachment part is configured to be in a shape matched with the face, back to the oral appliance, of the second forming part. According to the mold provided by the invention, low-cost and high-quality manufacturing of the oral appliance made of the personalized silica gel material can be realized.

Description

Technical Field

[0001] This application belongs to the field of mold manufacturing and application technology, specifically relating to molds for manufacturing oral appliances and their design methods, mold assemblies composed of the molds, and methods for manufacturing oral appliances. Background Technology

[0002] Liquid silicone rubber (LSR) is a polymer material with high tear strength, excellent flexibility and resilience, and good biocompatibility. Therefore, dental appliances made from this material have wide applications in oral medicine and sports protection. For example, bite guidance appliances made from liquid silicone are suitable for adjusting the bite relationship of children's upper and lower jaws, while soft braces and other products can be used to provide cushioning protection for teeth during strenuous exercise.

[0003] Currently, oral appliances made of liquid silicone are usually manufactured using injection molding: heated liquid silicone material is injected into a mold in the closed state through the injection port, and after cooling and solidification, it is demolded and then subjected to appropriate trimming, cleaning and other post-processing to obtain the finished product.

[0004] Besides mass-produced oral appliances with standardized specifications, in specific usage scenarios, such as when it is necessary to adjust the user's bite relationship individually or provide personalized movement protection, the shape of the oral appliance needs to be customized according to the user's internal oral structure (including tooth shape, dental arch shape, bite relationship, jaw shape, etc.). The number of such personalized oral appliances manufactured is often only a few, or even just one. Obviously, using expensive metal molds will undoubtedly greatly increase the manufacturing cost of the product.

[0005] A viable alternative is to use additive manufacturing technologies such as 3D printing to quickly and cost-effectively generate molds for personalized dental appliances. However, molds printed using existing 3D printing materials, such as SLA / DLP resins, have poor heat resistance and low tear strength, and therefore cannot withstand the high temperatures (120-200℃) and demolding stress of LSR injection molding. In addition, the cavity surface of molds 3D printed using resin and other materials is difficult to mirror polish like metal molds, so silicone tends to adhere to the surface, leading to demolding failure. If a release agent is used, not only is it difficult to control the coating thickness, but the release agent can also react with the resin material of the mold. Summary of the Invention

[0006] This application provides a mold for manufacturing dental appliances. By combining a reusable metal mold and a personalized mold using a resin base and layered film vacuum forming process, it enables economical, efficient, and precise liquid silicone injection molding of customized dental appliances. The mold includes:

[0007] A first molding part is used to construct a first cavity space, the first cavity space being shaped to match the first part of the oral appliance, wherein the first part is a part that can be adapted to the oral cavity structure of at least two users, or a part that can be adapted to the oral cavity structure of the same user at least two wearing stages.

[0008] The second molding part is made of a sheet-like elastic material that is softer than the first molding part, and is used to construct a second cavity space that matches the shape of the second part of the oral appliance other than the first part.

[0009] The attachment portion, made of a material harder than the second molding portion, has its side facing the oral appliance configured to have a shape that matches the side of the second molding portion facing away from the oral appliance.

[0010] This application also provides a method for designing a mold for manufacturing oral appliances, the method comprising the following steps:

[0011] Based on the wearing needs of a specific user, a design model for the oral appliance for that specific user is determined. The oral appliance consists of a first part and a second part. The first part is a part that can be adapted to the oral cavity structure of at least two users, including the specific user, or a part that can be adapted to the oral cavity structure of the specific user at at least two wearing stages.

[0012] Based on the design model of the oral appliance for the specific user, the shapes of the first molding part, the second molding part, and the attachment part of the mold are determined. The first molding part is used to construct a first cavity space, which matches the shape of the first part of the oral appliance for the specific user. The second molding part is shell-shaped and is used to construct a second cavity space, which matches the shape of the second part of the oral appliance for the specific user. The attachment part is used to attach the second molding part.

[0013] This application also provides a mold assembly for molding a plurality of oral appliances, the mold assembly comprising:

[0014] A first molding part, and several sets of corresponding second molding parts and attachment parts;

[0015] The first molding part, the second molding part, and the attachment part are all the first molding part, the second molding part, and the attachment part in the aforementioned mold;

[0016] in,

[0017] The second parts of the oral appliances molded by the second molding sections of each group have different shapes; and,

[0018] The second part of the oral appliance molded by the second molding part of each group and the first part of the oral appliance molded by the first molding part both have an outer surface that can be continuously transitioned.

[0019] This application also provides a method for manufacturing an oral appliance, wherein the oral appliance is molded using the aforementioned mold.

[0020] This application also provides a method for manufacturing oral appliances, wherein there are multiple oral appliances, and all of the multiple oral appliances are obtained by combining and molding the aforementioned molds.

[0021] The embodiments of this application provide a mold for manufacturing oral appliances, including a reusable first molding part and a personalized second molding part (and a matching attachment part), wherein the first molding part corresponds to the parts of the oral appliance that can be adapted to the usage needs of different users or the same user at different usage stages without personalized adjustments, and the second molding part corresponds to the parts of the oral appliance that need to be personalized and customized for the usage needs of different users or the same user at different usage stages.

[0022] By using molds made of different materials for common and personalized parts, this method can effectively combine the advantages of various existing mold materials, solving the core defects of single metal molds such as high cost and long manufacturing cycle, as well as single 3D printed resin molds such as difficulty in demolding, inability to cure, and easy adhesion of silicone to the surface. This enables low-cost, high-quality manufacturing of personalized silicone oral appliances. Attached Figure Description

[0023] Figure 1 A schematic diagram of the appearance of an oral appliance made of liquid silicon material;

[0024] Figure 2 for Figure 1 A top view of the oral appliance shown;

[0025] Figure 3 for Figure 1 A cross-sectional view of the oral appliance shown;

[0026] Figure 4 A perspective view of a mold for manufacturing oral appliances according to some embodiments of this application in a mold-closed state;

[0027] Figure 5A perspective view of a mold for manufacturing oral appliances according to some embodiments of this application in a mold-closed state;

[0028] Figure 6 This is a top view of a mold for manufacturing oral appliances according to some embodiments of this application in the mold-closed state;

[0029] Figure 7 An exploded view of a mold for manufacturing oral appliances according to some embodiments of this application;

[0030] Figure 8 A schematic diagram illustrating the principle of manufacturing oral appliances using molds provided in some embodiments of this application;

[0031] Figure 9 This is a schematic diagram of the structure of a first molding part provided according to some embodiments of this application;

[0032] Figure 10 This is a schematic diagram showing the extent of the first and second portions of an oral appliance in some embodiments;

[0033] Figure 11 This is a schematic diagram showing the extent of the first and second portions of an oral appliance in some embodiments;

[0034] Figure 12 This is a schematic diagram of multiple oral appliances having the same first part and different second parts in some embodiments;

[0035] Figure 13 This is a schematic diagram of the upper part of the attachment portion according to some embodiments of this application;

[0036] Figure 14 This is a schematic diagram of the upper part of the attachment portion according to some embodiments of this application;

[0037] Figure 15 This is a schematic diagram of the lower part of the attachment portion according to some embodiments of this application;

[0038] Figure 16 This is a schematic diagram of the upper part of the second molding section according to some embodiments of this application;

[0039] Figure 17 This is a schematic diagram of the upper part of the second molding section according to some embodiments of this application;

[0040] Figure 18 This is a schematic diagram of the lower part of the second molding section according to some embodiments of this application;

[0041] Figure 19This is a schematic diagram illustrating the molding process of the second molding part according to some embodiments of this application;

[0042] Figure 20 A cross-sectional view of a mold provided according to some embodiments of this application;

[0043] Figure 21 A cross-sectional view of a mold that includes only the attachment part and the molding part constructed of diaphragm material in an ideal state;

[0044] Figure 22 for Figure 21 A schematic diagram of the actual result of using diaphragm material to construct the molding section;

[0045] Figure 23 for Figure 21 A schematic diagram of the actual result of using diaphragm material to construct the molding section;

[0046] Figure 24 This is a flowchart of a mold design method provided according to an embodiment of this application. Detailed Implementation

[0047] The present application will now be further described based on preferred embodiments and with reference to the accompanying drawings.

[0048] In the description of the embodiments of this application, it should be noted that if terms such as "upper," "lower," "inner," or "outer" are used to indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this application is in use, they are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on this application. In addition, in the description of this application, in order to distinguish different units, the terms "first," "second," etc. are used in this specification, but these are not limited by the manufacturing order, nor should they be construed as indicating or implying relative importance. Their names may differ in the detailed description and claims of this application.

[0049] Furthermore, for ease of understanding, various components on the drawings have been enlarged or reduced, but this is not intended to limit the scope of protection of this application.

[0050] The vocabulary used in this specification is for illustrative purposes and is not intended to limit the scope of this application. It should also be noted that, unless otherwise expressly specified and limited, the terms "set," "connected," and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection, a direct connection, or an indirect connection via an intermediate medium; or they can refer to the internal communication between two components. Those skilled in the art will understand the specific meaning of these terms in this application.

[0051] Figures 1 to 3 A perspective view, a top view, and a sectional view (cutting lines are shown) of an oral appliance 8 made of liquid silicone material are illustrated. Figure 2 The oral appliance 8 (CC line) is an orthodontic appliance used to adjust or correct one or more problems in the user's tooth alignment, dental arch shape, and occlusal relationship of the upper and lower jaws.

[0052] As shown in the figures above, the oral appliance includes an outer support portion 81 extending in the shape of a dental arch (or, it can also be described as extending in a U-shape) and an inner support portion 82 (in this application, the labial side is the outer side and the lingual side is the inner side). The inner wall of the outer support portion 81 and the outer wall of the inner support portion 82 are continuously connected. Thus, through the upper half 811-2 of the inner wall of the outer support portion 81, the upper half 821-2 of the outer wall of the inner support portion 82, and the upper surface at the connection between the two, an arch-shaped upper alveolar 831 can be formed to accommodate the user's upper teeth (and may also include part of the upper gingiva); through the lower half 812-2 of the inner wall of the outer support portion 81, the lower half 822-2 of the outer wall of the inner support portion 82, and the lower surface at the connection between the two, an arch-shaped lower alveolar 832 can be formed to accommodate the user's lower teeth (and may also include part of the lower gingiva). Furthermore, in some descriptions of the structure of this oral appliance, the structure 84 with a certain thickness used to connect the outer support 81 and the inner support 82 is also referred to as a jaw pad, dental pad, or other similar terms.

[0053] When used, the oral appliance 8 is placed in the user's mouth. The outer support 81 is placed between the teeth and lips, with its outer wall (including the upper half 811-1 and the lower half 812-1 of the outer wall of the outer support 81) contacting the inner side of the lips, and its inner wall (including the upper half 811-2 and the lower half 812-2 of the inner wall of the outer support 81) contacting the teeth and may also contact a portion of the gums. The inner support 82 is placed between the teeth and tongue, with its outer wall (including the upper half 821-2 and the lower half 822-2 of the outer wall of the inner support 82) contacting the teeth and may also contact a portion of the gums, and its inner wall (including the upper half 821-1 and the lower half 822-1 of the inner wall of the inner support 82) being in the space within the teeth in the oral cavity and may contact the tongue (or may not).

[0054] In addition, in some embodiments, the portions of the left and right ends of the inner support portion 82 located in the molar area can further extend to the upper and lower jaws, so that at least some areas of the upper half 821-2 and the lower half 822-2 of its outer wall are in contact with the upper and lower jaws.

[0055] Through this wearing method, the user's upper and lower teeth are accommodated by the upper alveolar bone 831 and lower alveolar bone 832, respectively. The dental arch shape defined by the upper and lower alveolar bone is set according to the desired size, length, and curvature, such as the dental arch curve 85 in the figure. Similarly, the relative positional relationship of the upper and lower alveolar bone in three-dimensional space is set according to the desired occlusal relationship. Thus, by utilizing the excellent tensile strength and resilience of liquid silicone, adjustment forces can be continuously and gently applied to various parts of the oral cavity structure during the user's wearing process. For example, an arch-expanding force can be applied to the jawbone with an excessively narrow dental arch to solve the malocclusion problem caused by overcrowding of teeth; an adjustment force can also be applied to the condyle that controls the biting action of the mandible relative to the maxilla to solve occlusal disorder and various malocclusion problems caused thereby; and protrusions or ring-shaped structures can be set on the outer wall of the inner support part 82 to achieve correct tongue positioning.

[0056] It should be known that, Figures 1 to 3 The illustrated embodiment is merely one alternative, not the exclusive, implementation method of an oral appliance for orthodontic purposes. In fact, among the various orthodontic appliances currently disclosed, there are also those that... Figure 1Based on this, various modified embodiments are implemented. For example, in some embodiments, the outer support portion 81 and the inner support portion 82 extend from their middle portions (basically corresponding to the anterior tooth area) to the left and right sides respectively until they reach their left and right ends (basically corresponding to the molar area), and then connect to each other at the ends, thereby closing the upper and lower alveoli at the left and right ends; there are also oral appliances that adjust only the upper teeth or the maxillary portion, or oral appliances that adjust only the lower teeth or the mandibular portion, or separate upper and lower appliances that adjust the occlusal relationship by providing movement direction guiding structures (such as holes and posts that can cooperate with each other during occlusion) at their joint. All of the above-mentioned appliances, which are basically defined by the arched outer support portion 81 and the inner support portion 82 to define the alveoli that accommodate the teeth (including integral or separable upper and lower alveoli, or separate upper alveoli, or separate lower alveoli), are referred to as oral appliances in this application.

[0057] In addition to being used to adjust or treat various oral problems, this type of oral appliance can also be worn in the mouth during various sports activities to cushion and protect the teeth and jawbone (it can also be called a protective brace or similar term).

[0058] In the early days of oral appliances made of liquid silicone, they were generally manufactured using metal molds and injection molding. The cavity of the metal mold was designed to match the shape of the oral appliance. With the mold closed, heated liquid silicone was injected into the cavity through the injection port. After cooling, demolding, cleaning, trimming and other processes were carried out to obtain the finished oral appliance.

[0059] Obviously, due to the high cost of metal molds, this injection molding process is suitable for mass production of dental appliances of the same specifications (for example, the number of dental appliances that can be produced by a set of metal molds of 1,000, 5,000, or even 10,000 pieces, with the upper limit of the number of pieces generally determined by the normal service life of the metal mold). Therefore, in some existing descriptions of dental appliances, several standard models are generally provided according to the user's age or according to the approximate shape and length of the dental arch curve. Each model can be used by users of the same age group or with similar wearing conditions.

[0060] Compared to standard-sized dental appliances, non-standard personalized dental appliances can obviously achieve more precise orthodontic results or provide a more comfortable wearing experience. For example, based on the user's current oral structure (initial state) and the desired ideal oral structure (target state), several intermediate states (e.g., 2, 3, 4, 5, or even more intermediate states) can be generated, gradually adjusting from the initial state to the target state. Dental appliances corresponding to each intermediate state and the final target state are then generated, allowing for a smoother correction of various oral deformities. This avoids the significant morphological differences between two standard-sized dental appliances, which can cause noticeable discomfort when changing appliances during treatment. Furthermore, for users with missing teeth, custom-made protective braces with suitable protrusions can be provided to fill the missing areas, offering better protection during movement.

[0061] While personalized liquid silicone dental appliances offer the aforementioned significant advantages, providing a corresponding metal mold for each appliance would drastically increase manufacturing costs. Currently, the price of metal molds made of steel, aluminum, etc., used to manufacture dental appliances generally ranges from several thousand to tens of thousands of yuan. Furthermore, due to the need for mirror polishing of the cavity surfaces, the manufacturing cycle of metal molds can be as long as 4 to 12 weeks. This manufacturing cycle even exceeds the time it takes for the oral structure of the user (such as children, whose main target for occlusal correction is children) to spontaneously undergo significant changes. Consequently, by the time the personalized metal mold is completed, the dental appliance molded from it may no longer be suitable for the user's latest wearing needs.

[0062] Therefore, using various 3D printing technologies such as SLA (Stereolithography), SLS (Selective Laser Sintering), and FDM (Fused Deposition Modeling) to rapidly manufacture inexpensive molds using photosensitive resin materials, nylon powder materials, and thermoplastic materials has become a promising solution for manufacturing personalized liquid silicone oral appliances.

[0063] However, the inventors discovered that using any type of 3D printing technology to create molds for molding oral appliances from liquid silicone has some disadvantages: Firstly, the cavity surfaces of 3D-printed molds have uneven structures such as layered steps. If not smoothed, silicone easily adheres to the cavity surface, leading to demolding failure. However, the properties of these materials differ greatly from those of metals. The abrasives and tools used for metal polishing often damage resin molds, and the heat generated by high-speed polishing can also cause mold deformation. Therefore, it is difficult for the cavity surfaces of resin molds to achieve the same smoothness as metal molds. Secondly, photocurable resins have poor heat resistance (<80℃) and low tear strength (<50MPa), and cannot withstand the high temperatures (120-200℃) and demolding stresses when liquid silicone is injected into the mold.

[0064] Furthermore, as an additive manufacturing method, the cost of 3D printing molds is directly related to the amount of printing material consumed (roughly the material corresponding to the mold itself plus the material required for the necessary support structure). Therefore, when using 3D printing technology to produce products, once the mold volume increases, the material consumption increases accordingly, thus directly affecting the mold manufacturing cost. In contrast, the production of metal molds usually adopts a subtractive manufacturing method, which mainly generates molds by cutting and processing a whole piece of metal blank. Its cost is relatively less sensitive to the mold volume because material waste is usually considered to be included in the calculation.

[0065] Therefore, in order to manufacture personalized liquid silicone oral appliances at low cost and high quality, it is necessary to give full play to the advantages of existing mold manufacturing technologies and effectively avoid the problems that exist when molding personalized liquid silicone products.

[0066] Based on the above analysis, the inventors propose a novel mold for manufacturing oral appliances. Figure 4 , Figure 5 The appearance of the mold in its closed state is shown from different angles in some embodiments. Figure 6 and Figure 7 The above view and exploded view of the mold are shown in some embodiments. Figure 8 This is a schematic diagram illustrating the principle of molding an oral appliance 8 using this mold in some embodiments. Referring to the figures above, the mold includes a first molding part 1, a second molding part 2, and an attachment part 3.

[0067] The first molding part 1 is used to construct a first cavity space that matches the shape of the first part 801 of the oral appliance 8. In this application, the first part 801 of the oral appliance 8 is a part that can be adapted to the oral cavity structure of at least two users, or a part that can be adapted to the oral cavity structure of the same user in at least two wearing stages. The second molding part 2 is made of a sheet-like elastic material that is softer than the first molding part 1 and is used to construct a second cavity space. The second cavity space matches the shape of the second part 802 of the oral appliance 8 other than the first part 801. The attachment part 3 is made of a material that is harder than the second molding part 2, and its side facing the oral appliance 8 is constructed to have a shape that matches the side of the second molding part 2 facing away from the oral appliance 8.

[0068] like Figures 4 to 8 As shown, in some specific embodiments, in order to facilitate demolding, the second molding part 2 and the attachment part 3 are respectively constructed as upper and lower parts (here, "upper" and "lower" are consistent with the positional relationship of the upper teeth and lower teeth as commonly referred to). The upper part 21 of the second molding part 2, facing the oral appliance, is constructed to have a cavity surface that matches the upper half of the second part 802 of the oral appliance 8. The lower part 22 of the second molding part 2, facing the oral appliance, is constructed to have a cavity surface that matches the lower half of the second part 802 of the oral appliance 8. When the mold is closed, the two can form a second cavity space that completely accommodates the second part 802 of the oral appliance 8.

[0069] Similarly, the upper part 31 of the attachment part 3 facing the oral appliance 8 is configured to have a shape that matches the upper part 21 of the second molding part 2 facing away from the oral appliance 8; the lower part 32 of the attachment part 3 facing the oral appliance is configured to have a shape that matches the lower part 22 of the second molding part 2 facing away from the oral appliance 8.

[0070] The following detailed description of the specific implementation methods of each part of the mold, in conjunction with the accompanying drawings, provides a more comprehensive overview.

[0071] Figure 9 This is a schematic diagram of the structure of the first molding part 1 in some embodiments, wherein the left half is a three-dimensional structural view, and the upper right half is a cross-sectional view of the first molding part, with the cutting line being... Figure 6 The top view of the first molding part 1 is shown below the AA line.

[0072] like Figure 9 As shown, the side of the first molding part 1 facing the oral appliance 8 is configured to have a cavity surface 11 that matches the outer surface of the first part 801 of the oral appliance 8. The space surrounded by this cavity surface is the first cavity space.

[0073] In addition to the cavity surface 11, the side of the first molding part 1 facing the oral appliance 8 also includes several vertical (i.e., extending straight up and down) mold-closing surfaces, such as mold-closing surface 12-2 and mold-closing surface 12-3. In some embodiments of this application, such as... Figure 9 As shown, the projection of the two vertical mating surfaces 12-2 on the horizontal plane is an arch-shaped curve 803. This arch-shaped curve 803 extends from the anterior tooth area to the left and right sides along the two "peaks" of the outer support part 81 of the oral appliance 8. After extending to the left and right molar areas, it turns into straight lines 804 extending outward, thus forming two vertical mating surfaces 12-3 on the left and right sides, and finally defining the shape of the first part 801 of the oral appliance 8.

[0074] In the mold-closed state, these vertical mold-closed surfaces 12-2 and 12-3 are in close contact with the vertical mold-closed surfaces corresponding to the upper part 21 and lower part 22 of the second molding part 2, respectively, thereby forming a continuous transition shape between the cavity surface of the first molding part 1 and the cavity surface of the second molding part 2.

[0075] In addition to the cavity surface and the mold closing surface mentioned above, the other surfaces of the first molding part 1 include several horizontal or vertical mold closing surfaces 12-1 and an outer surface 13. In the mold closing state, the mold closing surfaces 12-1 are in close contact with the corresponding mold closing surfaces of the upper part 31 and the lower part 32 of the attachment part 3, which will be described later. They are locked by using the through hole 4 that runs through the entire mold and by the mutually cooperating studs and nuts.

[0076] In this application, the first part 801 of the oral appliance 8 refers to the part that can be adapted to the oral cavity structure of at least two users, or the part that can be adapted to the oral cavity structure of the same user in at least two wearing stages. The second part 802 refers to other parts besides the first part 801, and its specific meaning is explained in detail below.

[0077] As analyzed above, the user's oral cavity structure basically includes harder teeth (upper teeth, lower teeth), jaw (upper jaw, lower jaw), and softer skin and muscle tissue covering the harder parts, such as gums, labial skin, palatal skin, and tongue. Accordingly, different parts of the oral appliance 8 are used to support or separate different parts of the above-mentioned oral cavity structure.

[0078] Specifically, the first part 801 of the oral appliance 8 refers to the internal oral structure of the personalized oral appliance that can be adapted to different users or to different wearing periods of the same user.

[0079] In other words, the oral cavity structure supported or separated by the first part 801 of the oral appliance 8 has the same or similar shape for multiple users; or, for the same user, as the structure of some areas inside the oral cavity changes due to growth and development, the other areas whose structure remains basically unchanged are supported or separated by the first part 801 of the oral appliance 8.

[0080] refer to Figure 1 In the illustrated embodiment, for different users of oral appliances, such as multiple different adult users who need sports protection, although their tooth arrangement patterns are different or the degree of their maxillary protrusion is different, the structure supporting or isolating the above-mentioned areas needs to be customized. However, their anterior teeth, canines and even some molars can be isolated and supported by roughly the same external support. That is, the shape of the support structure of these parts does not need to be customized, but adopts the same shape.

[0081] For example, during the orthodontic treatment of a child user, some areas of the oral cavity structure may undergo significant changes at different stages of treatment. For instance, the teeth may be gradually aligned or the occlusion may be gradually adjusted, requiring personalized customization of the structure supporting or isolating these areas. However, during this gradual change, another area, such as the area between the front teeth, canines, and even some molars and the inner lip skin, can still be isolated and supported by roughly the same external support structure. In other words, the support structure for these parts can adopt the same shape without personalized design.

[0082] Therefore, like Figure 10 , Figure 11 As shown in the embodiments of this application, the personalized oral appliance 8 can be divided into two parts. The first part 801 is the part of the oral appliance 8 that can be adapted to the usage needs of different users or the same user at different usage stages (i.e., the wearing stage) without personalized adjustment. The second part 802 is the part of the oral appliance that needs to be personalized and customized for the usage needs of different users or the same user at different usage stages.

[0083] In this application, the manufacturing material of the first molding part 1 corresponding to the first part 801 can be selected according to the process parameters of liquid silicone injection molding, such as temperature, pressure, life and surface quality requirements. Optional manufacturing materials include at least one or a combination of cobalt-chromium alloy, hot work die steel, stainless steel, and aluminum alloy. Alternatively, other materials that can be used in mold manufacturing and meet the requirements of wear resistance, corrosion resistance, anti-adhesion, and thermal fatigue resistance can also be selected.

[0084] In some embodiments, the manufacturing process of the first molding part 1 can be as described above, using a high-precision machine tool to cut the metal blank according to the designed three-dimensional drawings, and then performing mirror polishing on its cavity surface; in other embodiments, it can also be manufactured using metal 3D printing technology, for example, using a dental prosthesis-specific metal 3D printer of model IE150-HII. This 3D printer can use SLS (Selective Laser Sintering) technology, using cobalt-chromium alloy powder as the printing material, and perform preliminary molding of the first molding part 1 by laser sintering. Then, after mirror polishing on its cavity surface 11, the first molding part 1 that can be used to manufacture dental appliances 8 can be obtained.

[0085] Clearly, the first molding part 1 can be repeatedly used in the process of manufacturing multiple oral appliances for different users, or in the process of manufacturing multiple oral appliances for different stages of use for the same user. Therefore, the first molding part can be used to manufacture at least two oral appliances, and the maximum number of oral appliances it can manufacture depends on its normal service life. By using the first molding part 1 multiple times to manufacture oral appliances, the cost incurred in molding the same first part 801 for multiple personalized oral appliances can be distributed, thereby effectively reducing the manufacturing cost of the complete personalized oral appliance.

[0086] The shape of the second part varies depending on the specific personalized oral appliance, to accommodate different users or the wearing requirements of the same user at different stages of use. For example, in Figure 12 In the illustrated embodiment, the oral appliance 8 on the left and the oral appliance 8' on the right have the same first part 801, the projection length of which is H1 in the midsagittal plane. The difference is that the dental arch curve of the second part 802' of the oral appliance 8' on the right is longer than that of the second part 802 on the left (the projection lengths in the midsagittal plane are H2' and H2, respectively, and H2'>H2). Therefore, the second parts 802' and 802 are designed with different shapes and are designed to transition continuously with the first part 801 at the junction to ensure that the first part 801 can match multiple second parts 802, 802', and 802"', etc., which are not shown in the figure.

[0087] In the embodiments of this application, the manufacturing of the second part of the oral appliance is completed by the second molding part 2 and the attachment part 3 that provides support for the second molding part 2. Obviously, for different personalized oral appliances, the cavity space of the second molding part 2 and the shape of the surface of the attachment part 3 for attaching the second molding part 2 should be designed separately according to the shape of those non-common parts in the user's oral cavity structure.

[0088] The side of the attachment part 3 facing the oral appliance 8 has a space that roughly matches the shape of the second part 802 of the oral appliance 8, but is larger in volume than the second part 802, and its function is to provide good support for the second molding part 2.

[0089] The material used to manufacture the attachment part 3 can be any 3D printing material suitable for various 3D printers. For example, photopolymer 3D printing materials such as photosensitive resin used in SLA 3D printers, selective laser sintering materials such as nylon powder used in SLS 3D printers, or fused deposition modeling (FDM) 3D printing materials used in FDM 3D printers. In selecting specific materials, the specific process parameters for liquid silicone injection molding can be referenced to choose materials that meet the requirements for strength and heat resistance.

[0090] The material used to manufacture the second molding part 2 is a sheet-like elastic material that is softer than the first molding part 1 and the attachment part 3, such as an orthodontic dental membrane. This type of dental membrane is usually used to manufacture transparent shell-shaped orthodontic appliances. The membranes typically come in different sizes such as 0.5 mm and 1 mm, have a smooth and wear-resistant surface, and have good tear resistance when stretched. After the dental membrane made of this sheet-like elastic material is tightly attached to the side of the attachment part 3 facing the oral appliance 8 by a laminating machine, the side facing the oral appliance 8 will be constructed to match the second part 802 of the oral appliance 8, and have a smooth, wear-resistant cavity surface with good tear resistance. Accordingly, in this application, the space surrounded by the cavity surface of the second molding part 2 is referred to as the second cavity space.

[0091] It should be noted that, in this application, the first part 801 and the second part 802 of the oral appliance 8 are used to characterize the three-dimensional spatial regions defined by the first cavity space and the second cavity space, respectively. That is, the shape of the first part 801 is determined by the shape of the first cavity surface 11 of the first molding part 1, and the shape of the second part 802 is determined by subtracting the first part 801 from the personalized oral appliance 8 after the area included by the first part 801 is determined.

[0092] Obviously, for Figure 8 , Figure 10 and Figure 11Although the oral appliances 8 shown herein are presented with their first part 801 and second part 802 separated from each other, it should be understood that this separate display is only for the convenience of illustrating that the shape of the two parts is determined by the first cavity space of the first molding part 1 and the second cavity space of the second molding part 2, respectively, and is integrally molded from the cavity space jointly formed by the first cavity space and the second cavity space when the mold is in the closed state. It should not be understood as first molding the first part 801 and the second part 802 separately by the first molding part 1 and the second molding part 2, and then manufacturing them by bonding or other means.

[0093] The following provides a detailed description of the specific embodiments of the second molding part 2 and the attachment part 3. As mentioned above, in some embodiments of this application, both the attachment part 3 and the second molding part 2 attached thereto include separable upper and lower parts, thereby making the mold suitable for the demolding process after the liquid silicone injection has cooled.

[0094] like Figure 4 , Figure 5 and Figure 7 As shown, in the molded state, a feeding channel 51 is formed between the upper part 21 and the lower part 22 of the second molding part 2. The feeding channel 51 is used to inject the material of the molded oral appliance 8 into the cavity space constructed by the second molding part 2 and the first molding part 1.

[0095] Furthermore, when the mold is closed, a discharge channel is formed between the first molding part 1 and the second molding part 2, or between the first molding part 1 and the attachment part 3 (depending on whether the second molding part 2 is attached to the attachment part 3 at the location of the discharge channel).

[0096] As mentioned above, in some embodiments of this application, similar to the molding part 2, the attachment part 3 also includes a separable upper part 31 and a lower part 32. Figure 13 The image shows the effect of viewing the upper part 31 of the attachment part 3 from a side-bottom view. To illustrate its structure more clearly, Figure 14 It has been flipped for display. (Reference) Figure 13 , Figure 14 The upper portion 31 of the attachment portion 3, facing the oral appliance, includes a shape that matches the upper half of the second part 802 of the oral appliance, but is slightly larger (to allow for attachment allowance for the upper portion 21 of the second shaping portion 2). For example, region 312 matches the upper half of the complete inner support portion 82, region 313 matches the upper alveolar ridge 83, and two regions 311 correspond to those regions in the upper half of the outer wall 81 that are included in the second part 802 of the oral appliance. Clearly, these shapes correspond to those parts of the oral appliance that require personalized design based on the user's oral cavity structure.

[0097] The structure of the lower part 32 of the attachment part 3 is shown in Figure 15 Similar to the upper part 31 of the attachment part 3, it also includes a shape that matches the lower half of the second part 802 of the oral appliance, but is slightly larger. For example, region 322 matches the lower half of the complete inner support part 82, region 323 matches the lower alveolar bone 83, and two regions 321 correspond to those regions in the lower half of the outer wall 81 that are contained in the second part 802 of the oral appliance.

[0098] In addition to the areas having an upper part 21 and a lower part 22 for attaching the second molding part 2, as shown in the figure, the upper part 31 and the lower part 32 of the attachment part 3 also include a generally horizontal mold-closing surface 314 and 324 on the side facing the oral appliance, which will be in close contact when the mold is in the mold-closing state.

[0099] Furthermore, in the mold-closing surface areas of the upper part 31 and lower part 32 of the attachment part 3, mutually cooperating positioning structures are respectively provided. In some optional embodiments, such as... Figure 14 and 15 As shown, the mutually cooperating positioning structure can be a plurality of positioning pins 318 and positioning grooves 328 that cooperate with them. By inserting the positioning pins 318 into the positioning grooves 328, it can be ensured that the cavity surfaces of each part of the mold can be aligned. Alternatively, other positioning structures known to those skilled in the art can also be used to achieve the positioning of the upper part 31 and lower part 32 of the attachment part 3 and the upper part 21 and lower part 22 of the second molding part.

[0100] As shown in the figure, in some preferred embodiments, at least a portion of the mold-closing surface area of ​​the upper part 31 and the lower part 32 of the attachment part 3 is recessed inward to form a film-coating compensation groove 315, 325. Thus, when the film is completely covered by the attachment part, thereby forming a cavity space, the portion around the cavity space will extend into the film-coating compensation groove 315, 325. After cutting off the excess portion of the film protruding from the film-coating compensation groove along the edge of the film-coating compensation groove 315, 325, a second forming part 2 including a second cavity space portion and a portion extending into the film-coating compensation groove 315, 325 around the second cavity space can be obtained.

[0101] The depth of the inward recesses of the covering compensation grooves 315 and 325 is approximately equal to or similar to the thickness of the sheet-like elastic material used in the second molding portion 2 that is covered on the attachment portion 3. For example, the two can be equal, or preferably, the depth of the inward recesses of the covering compensation grooves is slightly greater than the thickness of the sheet-like elastic material attached therein. In some optional embodiments, when the second molding portion 2 is constructed using a dental membrane sheet with a thickness of 1.0 mm, the thickness of the molded second molding portion 2 is approximately 0.5-0.7 mm, and the depth of the recesses of the covering compensation grooves can be set to be equal to or slightly greater than this molding thickness.

[0102] Furthermore, the upper part 31 and the lower part 32 of the attachment part 3 also include positioning structures that cooperate with the first molding part 1, thereby ensuring that the first molding part 1 can be accurately positioned by the attachment part 3 in the mold-closed state. For example, it can be like... Figures 13 to 15 As shown, the outer side of the upper part 31 of the attachment part 3 (as mentioned above, the outer side is the direction towards the lips and the inner side is the direction towards the tongue) is set to an open form, and the outer side of the lower part 32 of the attachment part 3 is provided with a generally arc-shaped groove 329. When the mold is closed, the lower part of the first molding part 1 is inserted into the groove 329 and is well positioned, and its cavity surface 11 is tightly joined with the cavity surface of the second molding part, thereby forming a complete cavity space that matches the oral appliance.

[0103] At the same time, such as Figures 13 to 15 As shown, since the area of ​​the second molding part 2 located around the second cavity surface continuously extends into the film compensation grooves 315 and 325, in the mold-closed state, the mold-closed surface of the first molding part 1 will contact the mold-closed surface of the second molding part 2 covering the attachment part 3, and firmly clamp and position the film of this part. This clamping and positioning is also particularly helpful in avoiding displacement of the second molding part 2 relative to the first molding part 1 or the attachment part 3 during the injection of liquid silicone. In addition, it can also effectively reduce or even eliminate the seam generated by the liquid silicone at the junction of the cavity surfaces of the first molding part 1 and the second molding part 2 during the molding process.

[0104] In some embodiments, the attachment part 3 and the first molding part 1 are further provided with mutually cooperating locking structures. For example, as shown in the figures above, a plurality of through holes 4 are provided through the upper part 31 and the lower part 32 of the first molding part 1 and the attachment part 3. By using a screw passing through the through holes 4 and a matching nut, the entire mold can be closed and locked. Similar to the positioning structure, other locking structures known to those skilled in the art can also be used to achieve the closure and locking of various parts of the entire mold.

[0105] Figure 16 , Figure 17 The structure of the upper part 21 of the second molding part 2 is shown, wherein, Figure 16The left half is the result viewed from a diagonal downward angle, and the right half is a side view; Figure 17 The left half of the middle section is a sectional view, with the cutting line being... Figure 6 The middle AA line has its right half flipped for display.

[0106] like Figure 16 , Figure 17 As shown, the upper part 21 of the second molding part 2 is made of a sheet-like elastic material with a thickness of D (generally, the thickness of the molded film is less than the thickness of the original film before molding). Its surface 211 facing the oral appliance 8 has a cavity surface for molding the upper half of the second part 802 of the oral appliance 8, and its surface 212 facing away from the oral appliance 8 is attached to the upper part 31 of the attachment part 3.

[0107] Specifically, surface 211 includes surface 2111-2 that matches the upper half 811-2 of the inner wall of the outer support portion 81 of the oral appliance, surface 2111-1 that matches the region included in the second part 802 of the oral appliance 8 in the upper half 811-1 of the outer wall of the outer support portion 81, surface 2112-1 that matches the upper half 821-1 of the inner wall of the inner support portion 82, and surface 2112-2 that matches the upper half 821-2 of the outer wall of the inner support portion 82.

[0108] In addition to the cavity surfaces of the upper half of the second part 802 used for molding oral appliances, the upper part 21 of the second molding part 2, facing the oral appliance, also includes a plurality of horizontal molding surfaces 2113-1, and vertical molding surfaces 2113-2 and 2113-3. The horizontal molding surfaces 2113-1 are embedded in the film compensation groove 315 of the upper half of the attachment part 3 by cutting off the excess portion. In the molded state, the horizontal molding surfaces 2113-1 are in close contact with the corresponding horizontal molding surfaces in the lower part 22 of the first molding part 1 and the second molding part 2, respectively. The vertical molding surfaces 2113-2 are in close contact with the vertical molding surfaces 12-2 of the first molding part 1, and the vertical molding surfaces 2113-3 are in close contact with the vertical molding surfaces 12-3 of the first molding part 1.

[0109] Figure 18 The structure of the lower part 22 of the second molding part 2 is shown. The left half of the figure is a perspective view, and the right half is shown in section. Its surface 221 facing the oral appliance 8 has cavity surfaces (including surfaces 2211-1, 2211-2, 2212-1, 2212-2) for molding the lower half of the second part 802 of the oral appliance 8, as well as mold-closing surfaces 2213-1, 2213-2, and 2213-3. Its surface 222 facing away from the oral appliance 8 is attached to the lower part 32 of the attachment part 3. The positions and shapes of the above surfaces can be seen in the upper part 21 of the second molding part 2, and will not be described again here.

[0110] A sheet-like elastic material can be applied to the attachment portion 3 using a hot-pressing process to form a second molded portion 2 with a second cavity space. Specifically, for example... Figure 19 As shown (only the lower half is described as an example), the dental membrane 6 and the lower part 32 of the attachment part 3 can be placed in the molding machine (not shown in the figure). After the dental membrane is heated to a plastic state by a heating tube or infrared heater, the air in the molding machine is removed by a vacuum pump. Under vacuum, the heated dental membrane 6 will be tightly adsorbed onto the surface of the lower part 32 of the attachment part 3, thereby forming a second cavity space and a part that can be attached to the film compensation groove (including the part that forms the feed channel 51 and the discharge channel 52). After cooling, the excess part of the dental membrane 6 is cut off, and the lower part 22 of the second molding part 2 and the lower part 32 of the attachment part 3 are obtained together.

[0111] In some preferred embodiments, such as Figures 4 to 7 ,as well as Figures 13 to 15 As shown in the figures, at least one vent 317 is provided on the upper part 31 of the attachment part 3. The vent 317 is used to connect the side of the upper part 31 of the attachment part 3 facing the second molding part 2 with other surfaces (e.g., upper surface 316) of the upper part 31 of the attachment part 3. Similarly, at least one vent 327 is provided on the lower part 32 of the attachment part 3. The vent 327 is used to connect the side of the lower part 32 of the attachment part 3 facing the second molding part 2 with other surfaces of the lower part 32 of the attachment part 3. During the hot pressing process, these vents can make the sheet elastic material and the attachment part 3 bond more tightly, so that the shape of the oral appliance obtained after molding is closer to its designed shape.

[0112] In this application, a reusable metal mold portion is combined with a resin attachment portion and a mold portion constructed of sheet-like elastic material. The metal mold undergoes a mirror finish, and the resin mold surface is coated, resulting in molds using different materials in different locations. This effectively solves the core defects of 3D printed personalized resin molds in liquid silicone injection molding, such as difficulty in demolding, inability to cure, and easy adhesion of silicone to the surface. Using this new method, the manufacturing cycle is short (3 days), the cost is low (tens to hundreds of yuan), production is highly economical, and personalization is strong, improving product comfort and therapeutic effects.

[0113] In addition to the advantages mentioned above, avoiding the complete covering of the attachment area with sheet-like elastic material to form a cavity space is particularly beneficial for making the shape of the molded oral appliance closer to its design shape. The following is a detailed explanation with reference to the accompanying drawings.

[0114] Figure 20This is a schematic diagram showing a mold cut along line AA, as provided in some embodiments of this application, with an enlarged view of circle E in the diagram. Figure 20 ,as well as Figure 10 , Figure 11 It can be seen that the junction of the cavity surfaces of the first molding part 1 and the second molding part 2 is basically located at the top of the two "peaks" extending along the arc-shaped curve 803 in the outer support part 81 of the oral appliance. By dividing the mold into the first molding part 1 and the second molding part 2 at this point, the problem of poor adhesion caused by excessive strain when the sheet elastic material is attached to the recessed structure of the attachment part 3 can be effectively resolved.

[0115] For comparison, Figure 21 A mold for a personalized oral appliance, consisting entirely of sheet-like elastic material attached to the attachment point in an ideal attachment state, is shown, with a magnified view of circle F in the figure. (See diagram below.) Figure 21 As shown, the mold includes an upper part 21' and a lower part 22' of the forming part, which are used to construct the complete upper cavity space and the complete lower cavity space of the dental appliance, respectively. The two cavity spaces are obtained by adsorbing sheet elastic material onto the upper part 31' and the lower part 32' of the attachment part by a hot pressing process. Therefore, the upper part 31' and the lower part 32' of the attachment part are completely constructed into a shape that corresponds to the upper and lower parts of the dental appliance but is slightly larger. Obviously, the mold shown in this embodiment does not have the structure corresponding to the first forming part 1 in the mold provided in this application.

[0116] Currently, the technology for adsorbing sheet-like elastic materials such as dental membranes onto 3D-printed dental arch models to construct shell-shaped dental instruments is quite mature. For example, Chinese invention patent CN107357949A discloses a process of heating and adsorbing dental membranes onto a dental model through thermoforming, and then cooling and curing to obtain shell-shaped dental instruments, as well as a method for optimizing the molding effect by adjusting the molding angle. The dental model includes alveolar bone, periodontal ligament, and teeth.

[0117] As can be seen in the aforementioned invention patent CN107357949A, the tooth model used to adsorb the dental membrane sheet has a generally convex shape facing the dental membrane sheet. Correspondingly, most of the area of ​​the dental membrane sheet facing the tooth model has a negative curvature (i.e., it is concave relative to the tooth model) after molding, with only some discrete areas showing accuracy in the gaps between teeth. For this tooth model shape that convexes towards the dental membrane sheet, the hot-pressed dental membrane sheet can adhere very tightly to the surface of the tooth model, thereby enabling the shape of the molded shell-shaped dental instrument to be quite close to the designed specifications.

[0118] However, when the mold is used to manufacture an oral appliance in which the alveolar bone 83 is defined by the outer support portion 81 and the inner support portion 82, the shape used to adsorb the heat-pressing film, except for the portion of the jawbone and dentition that protrudes toward the dental membrane ( Figure 21 Outside of region I, the portions corresponding to the outer support (region II) and inner support (region III) are concave away from the dental membrane, especially the portion corresponding to the outer support between the labia and teeth. This forms extremely deep grooves continuously distributed in a U-shape, arch-like pattern. Clearly, during hot pressing, the side of the dental membrane facing the attachment site needs to undergo significant deformation in this region and be constructed with a very high positive curvature to ensure it adheres tightly to the bottom of the groove, thus achieving… Figure 21 The ideal attachment shape is shown.

[0119] For such continuous, deep grooves, it is extremely difficult to ensure that the dental diaphragm is tightly adhered to the bottom of the groove, whether by adjusting the angle of the dental mold or other process parameters (such as increasing the temperature or the vacuum level in the molding machine). If the process parameters are not properly controlled, for example, when the negative pressure is insufficient, it may result in... Figure 22 As shown in the red section, the dental membrane sheet cannot adhere tightly to the attachment site in region II, resulting in insufficient height of the external support portion of the manufactured dental appliance; or, if the dental membrane sheet is overheated or the negative pressure is increased in order to make it adhere to the attachment site in region II, it will result in... Figure 23 As shown, the dental membrane in region II is overstretched, resulting in uneven thickness, or the attachment area is subjected to excessive stress, causing significant deformation, thus failing to achieve the strength required for subsequent liquid silicone injection molding.

[0120] As can be seen from the above analysis, in the mold provided by some preferred embodiments of this application, the first part 801 of the oral appliance formed by the first molding part 1 and the second part 802 formed by the second molding part 2 (i.e., the state after the dental membrane is hot-pressed) are located at the uppermost and lowermost ends of the outer support part. Moreover, the outer support part has a continuous positive curvature on its outer surface in this area that is continuously distributed in the shape of a dental arch. In some specific embodiments, the curvature radius of this area is in the range of [0.5mm, 5mm], that is, the curvature radius of this area is 0.5mm, or 5mm, or a value between 0.5mm and 5mm, such as 3mm.

[0121] After the cavity space is divided at this position, the deep groove that originally required a complete diaphragm to form the outer support part 81 will be converted into two separate cavity surfaces, and each cavity surface does not contain a groove with a large curvature. Obviously, this method of dividing the cavity space can effectively release the uneven strain generated by the sheet elastic material in order to form the deep groove, so that it can be well adsorbed on the attachment part with a more uniform strain state, thereby effectively improving the quality of the molded oral appliance.

[0122] It is evident that the cavity space shape of the first molding part 1 can not only be used to repeatedly manufacture the same parts in different oral appliances used by different users or the same user, but also effectively improve the product quality of oral appliances.

[0123] For the above considerations, in some alternative embodiments, without considering the need for reusability of the first molding part 1, and solely from the perspective of improving the quality of the dental appliance, the first molding part 1 can be manufactured in the same way as the second molding part 2. That is, the first molding part 1 can also be manufactured using 3D printing to create a personalized attachment part suitable for individual users, and then the dental membrane sheet can be attached to it, giving it the same structure as the second molding part 2. Although the first molding part cannot be reused, this method of dividing the first cavity space and the second cavity space of the dental appliance can still avoid the problem that if the mold is not separated in the part with greater curvature, the dental membrane sheet cannot be well molded into the desired deep groove during the hot pressing process to the attachment part.

[0124] Considering that the mold provided in this application is for personalized dental appliance products, therefore, Figures 10 to 12 As shown, the first part 801 of the oral appliance, which is molded by the first molding part 1, preferably includes the portion of the outer support part that contacts the inner side of the user's lip and is not located at the two ends of the outer support part 81. The two ends of the outer support part 81 are excluded from the first part because, considering that different users generally have little difference in their dental arches in the anterior region, but their length may vary significantly when extending to the molar regions on both sides. For example, the user's age and the presence of wisdom teeth will cause the alveolar bone to extend differently at the two ends. Accordingly, there is a need for personalized customization of the outer support part at the two ends.

[0125] In some specific embodiments, the boundaries between similar portions of the oral cavity structures of multiple users and the points where significant deviations begin can be statistically analyzed to determine the size of the area at the two ends of the external support 81 that is not included in the first portion 801. For example, in some optional embodiments, the portions at the two ends of the external support include the portions of the external support corresponding to the left and right posterior molar regions, and correspondingly, the first portion extends to cover the entire premolar region. Alternatively, in other optional embodiments, the portions at the two ends of the external support also include the portions of the external support corresponding to at least a portion of the left and right premolar regions, in which case the first portion only extends to cover a portion of the premolar region. Similarly, if multiple users have dental arches or dentitions that show significant differentiation starting from the canine region, the extension range of the first portion should be further reduced.

[0126] In some alternative embodiments, the oral appliance can be further subdivided along the two arched "peak" apex curves of the inner support portion 82 to alleviate strain when the sheet-like elastic material is attached to the attachment portion at this location. However, considering that the areas contacted by the inner support portion 82, including the palatal space and the tongue, often exhibit significant individual differences, the inner support portion 82 does not have a non-personally customizable shape like the outer support portion 81. Therefore, this part generally cannot be constructed from a metal part with a smooth mirror finish. A more suitable approach is to further subdivide the oral appliance at this location and then construct multiple subdivided cavity spaces in the form of sheet-like elastic material attached to multiple subdivided attachment portions.

[0127] It should also be noted that, Figures 4 to 20 The molds shown in the figures are only non-limiting embodiments of the molds provided in this application. In some other embodiments, the oral appliance may only have an outer support part, an inner support part, and a connecting structure to accommodate the upper alveolar bone, or only have an outer support part, an inner support part, and a connecting structure to accommodate the lower alveolar bone. Accordingly, the molds used to mold the above-mentioned oral appliances may also be composed of a first molding part, a second molding part, and an attachment part. Therefore, they also fall within the scope of protection of the molds provided in this application.

[0128] Figure 24 A design method is illustrated, which can be used to design a mold for manufacturing dental appliances as provided in this application. As shown in the figure, the design method includes the following steps:

[0129] The first step is to determine the design model of the oral appliance for the specific user based on the user's wearing needs. The oral appliance consists of a first part and a second part. The first part is a part that can be adapted to the oral cavity structure of at least two users, including the specific user, or a part that can be adapted to the oral cavity structure of the specific user in at least two wearing stages.

[0130] Specifically, various methods known to those skilled in the art can be used to generate design models. For example, when a specific user needs to undergo orthodontic treatment for oral deformities, a three-dimensional digital model of the oral structure can be established first based on the results of processing such as taking pictures or CT scans of the oral cavity. Then, based on the doctor's advice or by an experienced operator, the oral structure corresponding to the final orthodontic goal or the orthodontic goal of a certain intermediate stage can be obtained, and the initial design result of the corresponding oral appliance can be generated based on the obtained oral structure.

[0131] After obtaining the initial design results of the oral appliance, it can be fine-tuned so that its shape is adjusted to include a first part (i.e. the part common to oral appliances of multiple users, including the specific user, or the parts of the oral appliance used by the specific user in multiple wearing stages whose shape does not change) and a second part (i.e. the personalized part adapted to the specific user), thereby obtaining a three-dimensional digital design model of the oral appliance for the specific user.

[0132] The second step involves determining the shapes of the first molding part, the second molding part, and the attachment part of the mold based on the design model of the oral appliance for the specific user. The first molding part is used to construct a first cavity space, which matches the shape of the first part of the oral appliance for the specific user. The second molding part is shell-shaped and is used to construct a second cavity space, which matches the shape of the second part of the oral appliance for the specific user. The attachment part is used to attach the second molding part.

[0133] Specifically, Boolean operations and other methods can be used to obtain the shape of the first molding part and the shape of the second molding part combined with the attachment part from the first and second parts of the design model of the oral appliance obtained in the first step, respectively. Then, the shape of the second molding part combined with the attachment part is subjected to a certain thickness (i.e. the thickness of the sheet elastic material) of shelling process to separate the shape of the second molding part and the shape of the attachment part.

[0134] In some preferred embodiments, the morphology of the first molding part, the second molding part, and the attachment part can be further optimized, for example, by constructing vent holes, positioning structures, locking structures, film compensation grooves, glue injection channels, glue discharge channels, etc. All of the above operations are known to those skilled in the art and will not be described in detail here.

[0135] Some embodiments of this application also provide a mold assembly for molding a plurality of oral appliances, the mold assembly including a first molding part and a plurality of corresponding second molding parts and attachment parts.

[0136] Specifically, the first molding part, the second molding part, and the attachment part are all the first molding part, the second molding part, and the attachment part in the mold described above. Furthermore, the second part of the oral appliance molded by each group of second molding parts has a different shape. Also, the second part of the oral appliance molded by each group of second molding parts and the first part of the oral appliance molded by the first molding part both have an outer surface that can be continuously transitioned.

[0137] For example, like Figure 12 As shown, the first set of second molding parts and attachment parts have a cavity space that matches the second part 802 of the oral appliance 8, and can continuously transition with the cavity space of the first molding part, so that the second part 802 of the molded oral appliance 8 has an outer surface that can continuously transition with the first part 801 (it should be understood that there may still be a seam structure that needs further processing at its junction); the second set of second molding parts and attachment parts have a cavity space that matches the second part 802' of the oral appliance 8', and can continuously transition with the cavity space of the first molding part, so that the second part 802' of the molded oral appliance 8' also has an outer surface that can continuously transition with the first part 801.

[0138] Obviously, there can be a third group, a fourth group, etc., of such a one-to-one correspondence of the second molding part and the attachment part. The number of combinations generally depends on the normal service life of the first molding part.

[0139] Some embodiments of this application also provide a method for manufacturing an oral appliance, which uses the aforementioned mold to manufacture an oral appliance suitable for a specific user by liquid silicone injection molding.

[0140] Some embodiments of this application also provide a method for manufacturing oral appliances. This method uses the aforementioned mold combination, the same first molding part, and different sets of second molding parts and attachment parts to manufacture multiple oral appliances suitable for multiple specific users, or manufactures multiple oral appliances suitable for users with the same characteristics at different stages of use, through multiple liquid silicone injection molding.

[0141] In some specific embodiments, a suitable liquid silicone material can be selected according to the usage requirements of the target oral appliance (such as strength, hardness, tear strength, biocompatibility and safety), and the key process parameters of injection molding (such as mold temperature, injection / holding pressure, curing time, etc.) can be determined accordingly. After the mold design and manufacturing (including the first molding part, the second molding part and the attachment part, etc.) are completed, the mold is closed and LSR injection molding is carried out according to the preset process parameters. After the part is cured in the mold, it is demolded. If necessary, post-curing, deflashing and trimming can be performed to finally obtain an oral appliance or a combination of oral appliances made of liquid silicone material.

[0142] The specific embodiments of this application have been described in detail above. For those skilled in the art, several improvements and modifications can be made to this application without departing from the principle of this application, and these improvements and modifications also fall within the protection scope of the claims of this application.

Claims

1. A mold for manufacturing oral appliances, characterized in that it comprises: A first molding part is used to construct a first cavity space, the first cavity space being shaped to match the first part of the oral appliance, wherein the first part is a part that can be adapted to the oral cavity structure of at least two users, or a part that can be adapted to the oral cavity structure of the same user at least two wearing stages. The second molding part is made of a sheet-like elastic material that is softer than the first molding part, and is used to construct a second cavity space that matches the shape of the second part of the oral appliance other than the first part. The attachment portion, made of a material harder than the second molding portion, has its side facing the oral appliance configured to have a shape that matches the side of the second molding portion facing away from the oral appliance.

2. The mold for manufacturing oral appliances according to claim 1, characterized in that, When the oral appliance is used, the outer surface of the first part molded by the first molding part does not come into contact with any teeth.

3. The mold for manufacturing oral appliances according to claim 1, characterized in that, When the oral appliance is used, the outer surface of the first portion of the appliance, which is molded by the first molding part, contacts at least a portion of the inner side of the lip.

4. The mold for manufacturing oral appliances according to claim 3, characterized in that, The outer surface of the oral appliance has a positive curvature region that is continuously distributed in the shape of a dental arch at the junction of its first and second parts.

5. The mold for manufacturing oral appliances according to claim 4, characterized in that, The radius of curvature of the continuously distributed positive curvature region in the shape of a tooth arch ranges from [0.5 mm to 5 mm].

6. The mold for manufacturing oral appliances according to claim 1, characterized in that, The oral appliance includes an outer support portion and an inner support portion that extend in the shape of a dental arch; The inner wall of the outer support portion is continuously and transitionally connected to the outer wall of the inner support portion, thereby forming an upper alveolar bone and / or lower alveolar bone to accommodate the user's teeth.

7. The mold for manufacturing oral appliances according to claim 6, characterized in that, The first part of the oral appliance molded by the first molding part includes the portion of the outer support that contacts the inside of the user's lip and is not located at either end of the outer support.

8. The mold for manufacturing oral appliances according to claim 7, characterized in that, The portions at both ends of the external support include the portions of the external support corresponding to the left and right posterior molar regions.

9. The mold for manufacturing oral appliances according to claim 8, characterized in that, The portions at both ends of the external support also include portions of the external support corresponding to at least a portion of the left and right premolar regions.

10. The mold for manufacturing oral appliances according to claim 1, characterized in that, The second molding part includes a separable upper part and a lower part. When the mold is closed, a feeding channel is formed between the upper part and the lower part of the second molding part. The feeding channel is used to inject the material for molding the oral appliance into the cavity space constructed by the second molding part and the first molding part. The attachment part includes a separable upper part and a lower part. When the mold is closed, the upper and lower parts of the attachment part are positioned by a mutually cooperating positioning structure.

11. The mold for manufacturing oral appliances according to claim 10, characterized in that, When the mold is in the closed state, the first forming part is positioned by the attachment part; When the mold is closed, the attachment part and the first molding part are locked together by a locking structure that works together.

12. The mold for manufacturing oral appliances according to claim 10, characterized in that, When the mold is closed, a discharge channel is formed between the first molding part and the second molding part, or between the first molding part and the attachment part.

13. The mold for manufacturing oral appliances according to claim 10, characterized in that, The upper and lower parts of the attachment portion are each provided with at least one vent hole. The vent hole is used to connect the side of the upper part of the attachment portion facing the second molding portion with other surfaces of the upper part of the attachment portion, and to connect the side of the lower part of the attachment portion facing the second molding portion with other surfaces of the lower part of the attachment portion.

14. The mold for manufacturing oral appliances according to claim 10, characterized in that, When the mold is closed, there is a region in the area of ​​the second molding part that is not used to mold the second part of the oral appliance that is clamped and positioned by the attachment part and / or the first molding part.

15. The mold for manufacturing oral appliances according to claim 1, characterized in that, The first forming part is made of at least one of the following materials: cobalt-chromium alloy, hot work die steel, stainless steel, and aluminum alloy.

16. The mold for manufacturing oral appliances according to claim 1, characterized in that, The second shaping part is made of an orthodontic dental membrane.

17. The mold for manufacturing oral appliances according to claim 1, characterized in that, The attachment is made of at least one of the following 3D printing materials: stereolithography 3D printing material, selective laser sintering 3D printing material, and fused deposition modeling 3D printing material.

18. A method for designing a mold for manufacturing oral appliances, characterized in that, Includes the following steps: Based on the wearing needs of a specific user, a design model for the oral appliance for that specific user is determined. The oral appliance consists of a first part and a second part. The first part is a part that can be adapted to the oral cavity structure of at least two users, including the specific user, or a part that can be adapted to the oral cavity structure of the specific user at at least two wearing stages. Based on the design model of the oral appliance for the specific user, the shapes of the first molding part, the second molding part, and the attachment part of the mold are determined. The first molding part is used to construct a first cavity space, which matches the shape of the first part of the oral appliance for the specific user. The second molding part is shell-shaped and is used to construct a second cavity space, which matches the shape of the second part of the oral appliance for the specific user. The attachment part is used to attach the second molding part.

19. A mold assembly for molding a plurality of oral appliances, characterized in that, include: A first molding part, and several sets of corresponding second molding parts and attachment parts; The first molding part, the second molding part, and the attachment part are all the first molding part, the second molding part, and the attachment part in the mold as described in claim 1; in, The second parts of the oral appliances molded by the second molding sections of each group have different shapes; and, The second part of the oral appliance molded by the second molding part of each group and the first part of the oral appliance molded by the first molding part both have an outer surface that can be continuously transitioned.

20. A method for manufacturing an oral appliance, characterized in that, The oral appliance is molded using the mold as described in claim 1.

21. A method for manufacturing an oral appliance, characterized in that, The oral appliance is a plurality of such appliances, and all such oral appliances are formed by molding the mold assembly as described in claim 19.

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