Orthodontic temporary anchorage device implantation assistance device, and design method and system and forming method therefor

Abstract

Disclosed in the present application are an orthodontic temporary anchorage device implantation assistance device, and a design method and system and a forming method therefor. The assistance device comprises a positioning guide configured to be worn on teeth, wherein the guide is provided with a mounting abutment; and a guide member, which is separated from the guide and is provided with a guide end and a fixed end, wherein a guide cylinder is provided at the guide end, the fixed end is fixedly assembled on the mounting abutment, and the central axis of the guide cylinder defines the implantation position and angle of a temporary anchorage device. The present application ensures the temporary anchorage device implantation assistance effect, and reduces the design difficulty and costs.

Description

Orthodontic anchorage nail implantation auxiliary device and its design method, system and molding method

[0001] This application claims priority to a Chinese patent application filed on October 16, 2023, with application number 202311342433.0, entitled “Orthodontic anchorage nail implantation auxiliary device and its design method, system, and molding method”, and a Chinese patent application filed on October 16, 2023, with application number 202322783485.3, entitled “Orthodontic anchorage nail implantation auxiliary device”, all contents of which are incorporated by reference into this application. Technical Field

[0002] The present application relates to the technical field of dental orthodontics, and in particular to an orthodontic anchorage nail implantation auxiliary device, a design method and a design system, a molding method thereof, and a computer-readable storage medium. Background Art

[0003] During orthodontic treatment, we often encounter patients who need maximum support or conventional support cannot provide the required support force, such as the overall distal movement of the dentition or more intrusion movement of the posterior teeth. At this time, stronger support can be obtained by implanting support pins.

[0004] However, the direct implantation of anchorage nails requires high medical clinical skills. For example, it is often difficult for junior doctors or general practitioners to stably implant anchorage nails according to the target position and target angle. Therefore, auxiliary devices play an extremely important role in the implantation of anchorage nails.

[0005] Application Contents

[0006] In order to solve the problem that the direct implantation of the mentioned anchorage nail requires higher medical clinical skills, the purpose of this application is to provide an orthodontic anchorage nail implantation auxiliary device and its design method and design system, molding method, and a computer-readable storage medium, which is based on a reasonable design method of the anchorage nail implantation auxiliary device, which can simplify the preparation process of the auxiliary device and reduce the design difficulty, processing cost and difficulty of the auxiliary device.

[0007] To achieve the above application objectives, one embodiment provides an orthodontic anchorage nail implantation auxiliary device. The auxiliary device includes:

[0008] A positioning template for wearing on teeth, the template being provided with a mounting base; and

[0009] The guide piece is separately provided from the template and has a guide end and a fixed end. The guide end is provided with a guide cylinder, and the fixed end is mounted on the mounting base. The central axis of the guide cylinder limits the implantation position and angle of the anchor nail.

[0010] Preferably, the template is configured as an invisible brace formed by hot pressing a membrane.

[0011] Preferably, the template is adapted to fit a complete dentition or a portion of a dentition.

[0012] Preferably, the mounting base has a mounting surface, and the fixed end of the guide member has a reference surface;

[0013] The reference surface of the guide member has a standard topography, and the mounting surface of the mounting base has an adaptive topography matching the standard topography; or the mounting surface of the mounting base has a standard topography, and the reference surface of the guide member has an adaptive topography matching the standard topography;

[0014] When the fixed end is mounted on the mounting base, the reference surface is in contact with the mounting surface.

[0015] Preferably, the fixed end of the guide member is fixedly or detachably assembled to the mounting base by any one of bonding, welding, riveting, and interference fit; or, the template is provided with more than two mounting bases, the reference surface of the guide member matches the morphology of the mounting surface of any of the mounting bases, and the fixed end of the guide member is selectively detachably mounted on any one of the two or more mounting bases.

[0016] Preferably, the guide member is set as a standard member, and the orientation of the mounting surface of the mounting base on the template is designed to change with the implantation position and angle of the support nail, so that when the reference surface of the guide member is in contact with the mounting surface of the mounting base, the central axis of the guide tube of the guide member matches the implantation position and angle of the support nail.

[0017] Preferably, the guide end of the guide member has an inner side surface arranged toward the template, and the inner side surface is designed to change in matching with the actual morphology of the outer surface of the template.

[0018] Preferably, the reference surface is bonded to the mounting surface by an adhesive.

[0019] Preferably, the guide end of the guide member has an inner side surface arranged toward the template, and the inner side surface and the reference surface of the fixed end are arranged in an L shape.

[0020] Preferably, the mounting base is located in the posterior tooth area of ​​the template, and the mounting surface is located at the occlusal surface of the template; or, the mounting base is located in the anterior tooth area of ​​the template and is constructed as an extended flat guide plate structure, and the mounting surface is located on the flat guide plate structure.

[0021] Preferably, the included angle between the mounting surface and the occlusal surface is no greater than 45°.

[0022] Preferably, the mounting base further has a positioning protrusion protruding from the mounting surface, and the fixed end of the guide member has a positioning recessed hole recessed in the reference surface; when the fixed end is mounted on the mounting base, the positioning protrusion is inserted into the positioning recessed hole.

[0023] Preferably, at least two of the positioning protrusions and the positioning recesses are provided, and the two correspond to each other one by one.

[0024] Preferably, the positioning protrusion is interference fit in the positioning recess.

[0025] Preferably, the auxiliary device further includes a protective tube inserted into the guide cylinder.

[0026] Preferably, the guide member is configured as an integral injection molded part or a 3D printed resin part, and the protective tube is configured as a metal part or an alloy part.

[0027] Preferably, the guide cylinder comprises a cylindrical main body region and a non-cylindrical end region, and the protective tube comprises a cylindrical tube adapted to the cylindrical main body region and a rotation-stopping tube adapted to the non-cylindrical end region.

[0028] To achieve the above application objectives, one embodiment provides a design method for an orthodontic anchorage nail implantation auxiliary device. The design method comprises the following steps:

[0029] Obtaining a digital three-dimensional model of the oral cavity; the digital three-dimensional model of the oral cavity includes three-dimensional data of tooth crowns and three-dimensional data of tooth roots;

[0030] Determine the implant axis of the anchorage pin based on the three-dimensional data of the tooth root;

[0031] Obtain the reference surface data of the guide part and the center axis data of the guide cylinder;

[0032] The central axis data is matched with the implant axis, and based on the three-dimensional data of the crown, a three-dimensional model for manufacturing a positioning template is generated; the three-dimensional model has a mounting surface that matches the topography of the reference surface.

[0033] Preferably, the step of "obtaining a digital three-dimensional model of the oral cavity" specifically includes:

[0034] Collect dental data including three-dimensional data of the crown through intraoral scanner, extraoral scanner or silicone impression;

[0035] Use oral CBCT equipment to collect maxillofacial data including three-dimensional data of tooth roots;

[0036] The dental and maxillofacial data are fitted to obtain a digital three-dimensional model of the oral cavity.

[0037] Preferably, the oral cavity digital three-dimensional model contains three-dimensional data of gums;

[0038] In the step of "matching the central axis data with the implant axis and generating a three-dimensional model for manufacturing a positioning template based on the three-dimensional data of the crown", a three-dimensional model for manufacturing a positioning template is generated based on the three-dimensional data of the crown and the three-dimensional data of the gums;

[0039] The design method also includes the steps of generating inner side surface data of the guide member that matches the outer surface morphology of the gums in the three-dimensional model used to manufacture the positioning template, and designing the guide member by combining the inner side surface data, the reference surface data and the guide tube center axis data.

[0040] Preferably, the three-dimensional model in the step of "matching the central axis data with the implant axis, and generating a three-dimensional model for manufacturing a positioning template based on the three-dimensional data of the crown" is specifically set to: a three-dimensional model of the positioning template with the mounting surface, or a three-dimensional model of the tooth with the mounting surface.

[0041] To achieve the above application purpose, one embodiment provides a computer-readable storage medium on which a computer program is stored. When the computer program is executed by a processor, the steps in the design method are implemented.

[0042] To achieve the above-mentioned application purpose, one embodiment provides a design system for an orthodontic anchorage nail implantation auxiliary device, the design system including a memory and a processor, the memory storing a computer program that can be run on the processor, and when the processor executes the computer program, the steps in the design method are implemented.

[0043] To achieve the above application objectives, one embodiment provides a molding method for an orthodontic anchorage nail implantation auxiliary device. The molding method comprises the following steps:

[0044] preparing guide members;

[0045] Using the guide piece as a standard part and the design method, a three-dimensional model for manufacturing a positioning template is generated;

[0046] According to the three-dimensional model used to manufacture the positioning template, the positioning template is formed by adopting 3D printing technology or membrane hot pressing.

[0047] Preferably, the step of "preparing the guide member" specifically includes:

[0048] preparing an injection mold for the guide member, and molding the guide member using an injection molding process;

[0049] Alternatively, the guide member is formed by 3D printing technology according to the digital model of the guide member.

[0050] Preferably, the molding method further comprises the steps of:

[0051] A protective tube is prepared by using metal or alloy as the material to be processed and adopting a machining process; the protective tube matches the guide cylinder of the guide member.

[0052] Compared with the prior art, the beneficial effects of the present application include: basically, the auxiliary device can assist in limiting the implantation position and implantation angle of the support nail during the support nail implantation surgery, avoid deviation in the implantation position or implantation angle of the support nail, and solve the problem mentioned in the background technology that the direct implantation of the support nail requires higher medical clinical skills; and, further, on the basis of achieving the aforementioned auxiliary role, the guide member and the positioning template are set separately. For different cases, it is only necessary to adjust the position and angle of the mounting base that matches the positioning template and the guide member, thereby reducing the design difficulty, processing cost and difficulty of the auxiliary device. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] FIG1 is a schematic structural diagram of an invisible brace of an anchorage nail implantation auxiliary device according to an embodiment of the present application;

[0054] FIG2a is a schematic structural diagram of a guide member and a protective tube of an anchorage nail implantation auxiliary device according to an embodiment of the present application;

[0055] FIG2 b is a schematic structural diagram of a guide member and a protective tube of an anchorage nail implantation auxiliary device according to an embodiment of the present application from another perspective;

[0056] FIG3 is a schematic diagram of a dental brace of an orthodontic anchorage nail implantation auxiliary device according to an embodiment of the present application, wherein the dental brace is worn on a tooth and the guide member, the protective tube, and the dental brace are not assembled. In the figure, the main body of the dental brace is omitted and only the mounting base is retained;

[0057] FIG4 is a schematic diagram of an orthodontic anchorage nail implantation auxiliary device according to an embodiment of the present application in use, wherein the main body of the braces is omitted and only the mounting base is retained;

[0058] FIG5 is a step diagram of a design method of an anchorage nail implantation auxiliary device according to an embodiment of the present application;

[0059] FIG6 is a schematic block diagram of a processor of a design system for an anchorage nail implantation auxiliary device according to an embodiment of the present application;

[0060] FIG. 7 is a diagram showing the steps of a molding method of an anchorage nail implantation auxiliary device according to an embodiment of the present application. DETAILED DESCRIPTION

[0061] The following describes the implementation methods of the present application in detail with reference to the specific embodiments shown in the accompanying drawings. However, these embodiments do not limit the present application, and any structural, methodological, or functional modifications made by a person skilled in the art based on these implementation methods are included within the scope of protection of the present application.

[0062] 1 to 4 , this embodiment provides an auxiliary device 100 for providing direct or indirect assistance during the implantation of anchorage pins in orthodontic treatment.

[0063] In one case, the auxiliary device 100 provides a direct auxiliary function. For example, the auxiliary device 100 is worn in the patient's mouth. The doctor can use the hollow guide tube 21 of the auxiliary device 100 and the support nail implantation tool head 9 to implant the support nail along the target angle to the target position in the patient's mouth, wherein the central axis of the hollow guide tube 21 is used to limit the implantation angle and implantation position of the support nail.

[0064] In another case, the auxiliary device 100 provides an indirect auxiliary effect. For example, the auxiliary device 100 is worn in the patient's mouth. The doctor can use the hollow guide tube 21 of the auxiliary device 100 to drill a bottom hole at the target position in the patient's mouth along the target angle with a tool drill bit, and then implant the support nail into the bottom hole. The central axis of the hollow guide tube 21 is used to limit the angle and position of the bottom hole, thereby limiting the implantation angle and implantation position of the support nail.

[0065] Specifically, referring to FIG. 1 and FIG. 2 a , the auxiliary device 100 includes a positioning template 10 and a guide member 20 .

[0066] Referring to Figure 1 , a positioning template 10 is worn on the teeth to position the auxiliary device 100 relative to the teeth. The positioning template 10 has a cavity that can accommodate multiple teeth. When worn on the teeth, the positioning template 10 wraps around the teeth, effectively enclosing the teeth within the cavity.

[0067] 2a, the guide member 20 is provided with a guide cylinder 21. As the name implies, the guide cylinder 21 is a cylindrical structure, wherein the axis thereof is used to limit the implantation position and implantation angle of the anchorage nail during the anchorage nail implantation operation.

[0068] The guide member 20 is provided separately from the positioning template 10 and assembled together for use. Specifically, the positioning template 10 is provided with a mounting base 11, which is used to mount the guide member 20. One end of the guide member 20, which is provided with a guide cylinder 21, is defined as a guide end 201, and the other end of the guide member 20 is defined as a fixed end 202, which is mounted on the mounting base 11.

[0069] In this way, the auxiliary device 100 of this embodiment can basically assist in limiting the implantation position and implantation angle of the support nail during the support nail implantation surgery, thereby avoiding deviation in the implantation position or implantation angle of the support nail; more importantly, on the basis of achieving the aforementioned auxiliary role, the guide member 20 and the positioning template 10 are separately set and assembled for use. For different cases, it is only necessary to design the positioning template 10 to match the guide member 20, thereby reducing the design difficulty, processing cost and difficulty of the auxiliary device 100.

[0070] Referring to FIG1 , preferably, the positioning template 10 is configured as an invisible brace formed by hot pressing of a diaphragm, that is, a transparent brace. When worn on the teeth, the teeth located in the accommodating cavity of the brace can be seen through the brace. The brace can be prepared using known materials commonly used in existing invisible braces, for example, it can be a transparent diaphragm of polymer material. In this way, the corresponding brace can be formed by the diaphragm hot pressing technology, and the brace and the guide member 20 are matched based on the mounting base 11, further reducing the design difficulty, processing cost and difficulty of the auxiliary device 100. Of course, the structure of the positioning template 10 is not limited to invisible braces. For example, it can also be configured as a silicone positioning plate or other existing guide plate structures known in the art.

[0071] In this embodiment, the positioning template 10 is adapted to a complete dentition, such as the maxillary dentition or the mandibular dentition, and when worn in the oral cavity, the accommodating cavity of the positioning template 10 accommodates the complete dentition. In an alternative embodiment, the positioning template 10 can also be changed to be adapted to part of the teeth of a dentition, such as two teeth adjacent to the anchor pin implantation position, for example, if the anchor pin implantation position is between teeth No. 5 and No. 6 of the maxillary teeth, then the positioning template 10 is adapted to teeth No. 5 and No. 6 of the maxillary teeth; for example, if there are more teeth near the anchor pin implantation position, for example, if the anchor pin implantation position is in the posterior tooth area, then the positioning template 10 is adapted to all teeth in the entire posterior tooth area.

[0072] Referring to Figure 2a , as previously described, the guide member 20 is formed separately from the positioning template 10. The guide member 20 can be configured as a one-piece injection molded part or a 3D-printed part, and can be made of biosafe, photocurable resins, acrylic resins, and other materials. This allows the guide member 20 to be mass-produced as a standard component, requiring only the design and manufacture of the corresponding positioning template 10 for each case. This significantly reduces the overall design complexity, processing costs, and difficulty of the auxiliary device 100.

[0073] 1 to 2 b , in this embodiment, the mounting base 11 has a mounting surface 110, and the fixed end 202 of the guide member 20 has a reference surface 22. When the fixed end 202 is fixedly mounted on the mounting base 11, that is, when the guide member 20 is mounted on the positioning template 10, the reference surface 22 is in contact with the mounting surface 110.

[0074] The reference surface 22 of the guide member 20 has a standard shape, and the mounting surface 110 of the mounting base 11 has an adaptive shape that matches the standard shape; alternatively, the mounting surface 110 of the mounting base 11 has a standard shape, and the reference surface 22 of the guide member 20 has an adaptive shape that matches the standard shape. In this way, the topography of the reference surface 22 and the mounting surface 110 match, so that the reference surface 22 fits the mounting surface 110, thereby facilitating the guide member 20 to be mounted on the mounting surface 110 of the mounting base 11 of the positioning template 10 via its reference surface 22.

[0075] At the same time, with the reference surface 22 as a standard shape and the guide part 20 as a standard part, when designing the auxiliary device 100 for a case, it is only necessary to design the positioning template 10. The orientation of the mounting surface 110 on the positioning template 10 is designed to change with the implantation position and angle of the support nail, so that when the reference surface 22 of the guide part 20 is attached to the mounting surface 110, the central axis of the guide tube 21 of the guide part 20 matches the implantation position and angle of the support nail. In this way, the design and molding of the entire positioning template 10 are simple and quick.

[0076] Preferably, the topography of the reference surface 22 and the mounting surface 110 matches. For example, as shown in the figure, the topography of the reference surface 22 is substantially flat, and the topography of the mounting surface 110 is also substantially flat, so that the two can basically fit together. Alternatively, in a variation, the topography of the reference surface 22 is substantially convex, and the topography of the mounting surface 110 is substantially concave, so that the two can basically fit together; or, the topography of the reference surface 22 is substantially concave, and the topography of the mounting surface 110 is substantially convex, so that the two can basically fit together; or other matching topography. In general, the matching degree between the topography of the mounting surface 110 and the topography of the reference surface 22 only needs to meet the tolerance of the fixing method (that is, as long as the two can basically fit together and the fitting state is stable), and does not need to be 100% identical.

[0077] In one embodiment, the fixed end 202 of the guide member 20 and the mounting base 11 can be fixedly assembled by any of bonding, welding, riveting, and interference fit. Preferably, the fixed connection is fixed by adhesive bonding. For example, the reference surface 22 is bonded to the mounting surface 110 by an adhesive. In this way, the fixed connection of the guide member 20 and the mounting base 11 can be achieved. Of course, other assembly methods are not excluded. For example, the fixed end 202 of the guide member 20 and the mounting base 11 can be detachably assembled by any of bonding, welding, riveting, and interference fit. In this way, the same guide member 20 can be reused. For example, in one embodiment, when more than two places on the dentition need to be implanted with support nails, the positioning template 10 is provided with more than two mounting bases 11. The reference surface 22 of the same guide member 20 matches the morphology of the mounting surfaces 110 of the two or more mounting bases 11, so that the fixed end 202 of the guide member 20 can be selectively detachably mounted on any of the two or more mounting bases 11.

[0078] In this embodiment, from the structural aspect of the guide member 20, the guide end 201 has an inner side surface 23 facing the positioning template 10, and the inner side surface 23 and the reference surface 22 of the fixed end 202 are roughly L-shaped, and the angle between the two is roughly 90°, or an obtuse angle slightly greater than 90°. As mentioned above, the guide member 20 is set as a standard part, and the shape of the inner side surface 23 and the shape of the positioning template 10 have no matching relationship; in a variant embodiment, the inner side surface 23 of the guide member 20 is designed to change with the actual shape of the outer surface 12 of the positioning template 10, so that the inner side surface 23 and the outer surface 12 of the positioning template 10 can match and fit, thereby stabilizing the position of the guide member 20 and the positioning template 10. In this way, the guide member 20 is a personalized customized part according to the actual shape of different positioning templates 10.

[0079] Next, regarding the structure of the positioning template 10, in the accompanying drawings, the mounting base 11 is located in the posterior region of the positioning template 10, and the mounting surface 110 is located on the occlusal surface of the positioning template 10, to accommodate the use of anchor pins in the posterior region. This ensures that the auxiliary device 100 maintains a more stable position during use, ensuring the effectiveness of the auxiliary positioning. In this example, the angle between the mounting surface 110 and the occlusal surface is no greater than 45°.

[0080] In addition to the posterior tooth area, in a variant embodiment, for the case where the anchorage nail is implanted in the anterior tooth area, the mounting base 11 can also be located in the anterior tooth area of ​​the positioning template 10, and constructed as an extended flat guide plate structure, and the mounting surface 110 is located on the flat guide plate structure, so that when the guide member 20 is installed on the mounting base 11, the central axis of the guide tube 21 of the guide member 20 corresponds to the implantation axis of the anchorage nail in the anterior tooth area.

[0081] Furthermore, the mounting base 11 also has a positioning protrusion 111 that protrudes from the mounting surface 110. Correspondingly, as shown in FIG2b , the fixed end 202 of the guide member 20 has a positioning recess 221 that is recessed in the reference surface 22. When the fixed end 202 is fixedly mounted on the mounting base 11, that is, when the guide member 20 is fixedly mounted to the positioning template 10, the reference surface 22 is in contact with the mounting surface 110, and the positioning protrusion 111 is inserted into the positioning recess 221. This facilitates the rapid positioning of the guide member 20 during installation on the positioning template 10, and further stabilizes the positional relationship between the guide member 20 and the positioning template 10.

[0082] There are at least two positioning protrusions 111 and at least two positioning recesses 221 .

[0083] Preferably, the number of positioning protrusions 111 and positioning recesses 221 is equal and corresponds one to one, that is, each positioning protrusion 111 is correspondingly inserted into a positioning recess 221. For example, in the figure, there are two positioning protrusions 111 and two positioning recesses 221. Of course, in alternative embodiments, the number of positioning protrusions 111 and positioning recesses 221 can also be changed to be different, such as the number of positioning recesses 221 is greater than the number of positioning protrusions 111. For example, as a universal standard part, the guide member 20 is provided with more positioning recesses 221, and for different cases, according to the positioning requirements, the number of positioning protrusions 111 of the designed positioning template 10 is no more than the number of positioning recesses 221.

[0084] As mentioned above, the positioning protrusion 221 is interference-fitted into the positioning recess 221 . Thus, while achieving the aforementioned installation and positioning function, the firmness of the fixed connection between the guide member 20 and the positioning template 10 can also be improved.

[0085] In this embodiment, the positioning protrusion 221 is configured as a cylindrical structure, the central axis of which is substantially perpendicular to the mounting surface 110 , which facilitates the plug-in fit between the positioning protrusion 221 and the positioning recess 221 .

[0086] In addition, the auxiliary device 100 also includes a protective tube 30, which is inserted into the guide cylinder 21. Specifically, it can be installed in the guide cylinder 21 from the outside away from the positioning template 10. In this way, when the auxiliary device 100 is used in the anchorage nail implantation surgery, the anchorage nail implantation tool head 9 (for example, in the case of providing direct auxiliary effect as described above) or the tool drill bit (for example, in the case of providing indirect auxiliary effect as described above) contacts the protective tube 30 but not the guide member 20, thereby improving the guiding accuracy and the wear resistance of the guide member 20, avoiding the wear of the guide member 20 and affecting the guiding accuracy, and preventing the guide member 20 from generating debris due to friction and falling into the patient's mouth.

[0087] The protection tube 30 is preferably configured as a metal part or an alloy part, such as any one of stainless steel, titanium alloy or pure titanium, which can be prepared as a universal standard part using a machining process.

[0088] For situations where the auxiliary device 100 provides direct assistance, the inner diameter of the protective tube 30 is set to 3.5-4.5 mm, preferably 4.5 mm, based on the conventional size of the drill bit used for drilling the base hole. For situations where the auxiliary device 100 provides indirect assistance, the inner diameter of the protective tube 30 is set to 0.5-1.7 mm, preferably 0.8 mm, 1 mm, 1.2 mm, or 1.5 mm, based on the size of the anchor nail and the conventional size of the anchor nail insertion tool head 9. These inner diameter settings of the protective tube 30 increase the applicable scenarios of the auxiliary device 100 and improve its versatility.

[0089] In this embodiment, the guide cylinder 21 includes a cylindrical main region 211 and a non-cylindrical end region 212, and the protective tube 30 includes a cylindrical tube 31 adapted to fit within the cylindrical main region 211 and a rotation-stopping tube 32 adapted to fit within the non-cylindrical end region 212. Thus, the cooperation between the rotation-stopping tube 32 and the non-cylindrical end region 212 prevents the protective tube 30 from rotating relative to the guide member 20 during surgery when driven by the anchor nail insertion tool head 9 or the tool drill bit, thereby preventing wear on the guide member 20 and ensuring guiding accuracy.

[0090] In the figure, the non-cylindrical end region 212 is a hexagonal inner edge formed at the outer end of the guide tube 21. Correspondingly, the anti-rotation tube 32 is a hexagonal outer edge formed at one end of the protective tube 30. While the non-cylindrical end region 212 and the anti-rotation tube 32 are configured to have the same shape, they can also be configured to have different shapes.

[0091] 5 , this embodiment further provides a design method for the auxiliary device 100 , that is, the auxiliary device 100 described above can be designed using this design method.

[0092] Specifically, the design method of this embodiment includes step S100: obtaining a digital three-dimensional model of the oral cavity; the digital three-dimensional model of the oral cavity contains three-dimensional data of tooth crowns and three-dimensional data of tooth roots.

[0093] In step S100 , obtaining the oral cavity digital three-dimensional model can be implemented using existing technologies known in the art.

[0094] For example, in one embodiment, step S100 specifically includes:

[0095] S101: Collecting dental data including three-dimensional data of tooth crowns through an intraoral scanner, an extraoral scanner, or a silicone impression;

[0096] S102: Using oral CBCT equipment, maxillofacial data including three-dimensional data of tooth roots are collected;

[0097] S103: Fitting the dental and maxillofacial data to the maxillofacial data to obtain a digital three-dimensional model of the oral cavity.

[0098] Here, there is no restriction on the order of performing step S101 and step S102, and the two can be performed in any order.

[0099] The design method of this embodiment includes step S200: determining the implantation axis of the anchorage pin based on the three-dimensional data of the tooth root.

[0100] In one embodiment, the anchor pin implantation axis determined in step S200 determines the anchor pin implantation position and implantation angle. Therefore, step S200 essentially determines the anchor pin implantation position and implantation angle based on the three-dimensional tooth root data.

[0101] The design method of this embodiment includes step S300: obtaining the reference surface data of the guide member and the central axis data of the guide cylinder.

[0102] In one embodiment, in step S300, the guide member 20 is used as a universal standard part, and the reference surface 22 data of the guide member 20 and the center axis data of the guide cylinder 21 can be obtained by writing. Of course, in step S300, in addition to the reference surface 22 data and the center axis data of the guide cylinder 21, other structural and dimensional data of the guide member 20 can also be obtained. That is, step S300 at least needs to obtain the reference surface 22 data and the center axis data of the guide cylinder 21, so that the subsequent step S400 uses the reference surface and guide cylinder of the guide member 20 as the standard to design a mounting base 11 (specifically, the orientation of the mounting surface 110 of the mounting base 11) that matches the guide member 20 on the positioning template 10.

[0103] The design method of this embodiment includes step S400: matching the central axis data with the implant axis, and generating a three-dimensional model for manufacturing a positioning template based on the three-dimensional data of the crown; the three-dimensional model has a mounting surface that matches the morphology of the reference surface.

[0104] In combination with the foregoing, the implantation axis of the support nail determines the implantation position and implantation angle of the support nail; and it can be understood that, whether the auxiliary device designed in this embodiment is used for direct assistance (for example, the aforementioned use of the support nail implantation tool head 9 to implant the support nail directly through the auxiliary device) or for indirect assistance (for example, the aforementioned use of a tool drill bit to drill a bottom hole through the auxiliary device, and then implanting the support nail into the bottom hole), the implantation axis of the support nail is determined by the central axis of the guide tube 21 when the guide part 20 in the auxiliary device 100 is installed on the positioning template 10.

[0105] In step S400, the central axis data of the guide tube 21 is matched with the implantation axis of the support nail determined in step S200. The result of the matching is that when the guide member 20 is installed on the positioning template corresponding to the three-dimensional model finally obtained for manufacturing the positioning template, the central axis of the guide tube 20 basically coincides with the determined implantation axis of the support nail.

[0106] Moreover, in step S400, the three-dimensional model finally obtained for manufacturing the positioning template has a mounting surface 110, and the mounting surface 110 matches the morphology of the reference surface 22, so that when the guide member 20 is installed on the positioning template 10 corresponding to the three-dimensional model finally obtained for manufacturing the positioning template, the reference surface 22 fits against the mounting surface 110, thereby facilitating the guide member 20 to be fitted onto the mounting surface 110 of the positioning template 10 through its reference surface 22.

[0107] Preferably, the topography of the reference surface 22 and the mounting surface 110 matches. For example, as shown in the figure, the topography of the reference surface 22 is substantially flat, and the topography of the mounting surface 110 is also substantially flat, so that the two can basically fit together. Alternatively, in a variation, the topography of the reference surface 22 is substantially convex, and the topography of the mounting surface 110 is substantially concave, so that the two can basically fit together; or, the topography of the reference surface 22 is substantially concave, and the topography of the mounting surface 110 is substantially convex, so that the two can basically fit together; or other matching topography. In general, the matching degree between the topography of the mounting surface 110 and the topography of the reference surface 22 only needs to meet the tolerance of the fixing method (that is, as long as the two can basically fit together and the fitting state is stable), and does not need to be 100% identical.

[0108] In step S400, the three-dimensional model obtained for manufacturing the positioning template can be specifically configured as: a three-dimensional model of the positioning template 10 having the mounting surface 110, or a three-dimensional model of the tooth having the mounting surface 110. In other words, the three-dimensional model can be directly a model of the positioning template 10, and the positioning template can be directly manufactured based on the model by 3D printing or other methods; or the three-dimensional model can be a model of the tooth, and the positioning template can be manufactured based on the model by film hot pressing.

[0109] The design method of this embodiment is understood in conjunction with the structure of the auxiliary device 100. The pre-designed guide member 20 is used as a universal standard member. The central axis of the guide cylinder 21 of the guide member 20 is matched with the determined axis of the anchor nail implantation. The data of the central axis of the guide cylinder 21 of the guide member 20 and the reference surface 22 are combined to obtain the information of the mounting surface 110 matching the reference surface 22. For example, the position and angle of the mounting surface 110 are determined, and finally a three-dimensional model for manufacturing the positioning template 10 is generated. The three-dimensional model has a mounting surface 110, and then the positioning template 10 with the mounting surface 110 can be produced from the three-dimensional model. In this way, the design of the auxiliary device 100 (especially the design of the positioning template 10) can be completed.

[0110] In this way, the guide member 20 can be standardized and mass-produced with strong versatility. According to the implantation position and implantation angle of the support nails in different cases, it is only necessary to adjust the position and angle of the mounting surface 110 according to the design method to design an adaptive positioning template 10, thereby reducing the design difficulty, processing cost and difficulty of the auxiliary device.

[0111] In one embodiment, the reference surface 21 of the guide member 20 is provided with one or two or more positioning recesses 221; in step 400, the three-dimensional model obtained for manufacturing the positioning template contains no more positioning protrusions 111 than the number of positioning recesses 221, that is, the number of generated positioning protrusions 111 is equal to or less than the number of positioning recesses 221, and each positioning protrusion 111 is designed to be plugged and fitted with a positioning recess 221.

[0112] The positioning protrusion 111 is designed to be interference-fitted into the positioning recess 221 .

[0113] In addition, in step S400, the three-dimensional model obtained for manufacturing the positioning template is suitable for manufacturing a partial dentition that includes the teeth where the anchor pin is located, or for manufacturing a complete dentition. For example, when adapting to the complete dentition, the positioning template formed based on the three-dimensional model can be worn on the complete dentition (or the complete dentition can be accommodated in the accommodating cavity of the positioning template); for example, when adapting to the partial dentition that includes the teeth where the anchor pin is located, for example, the mounting surface 110 is located at two adjacent teeth at the implantation position of the anchor pin, and the positioning template formed based on the three-dimensional model can be worn on at least these two teeth.

[0114] Furthermore, in one embodiment, in step S300, while obtaining the guide member's reference surface data and the guide cylinder's central axis data, the spatial positional relationship data between the reference surface and the guide cylinder's central axis is also obtained. Furthermore, in step S400, the central axis data is matched with the implant axis. Based on this, and in combination with the spatial positional relationship data, the position and angle of the mounting surface that matches the topography of the reference surface are determined, thereby generating a three-dimensional model for manufacturing a positioning template.

[0115] In addition, in this embodiment, as mentioned above, the guide member 20 is a standard member, not a personalized customized member; in a variant embodiment, the guide member 20 is a personalized customized member. For example, as mentioned above, the inner side surface 23 of the guide member 20 is designed to change with the actual morphology of the outer surface 12 of the positioning template 10, so that the inner side surface 23 and the outer surface 12 of the positioning template 10 can match and fit, thereby stabilizing the position of the guide member 20 and the positioning template 10. In this way, the guide member 20 is a personalized customized member according to the actual morphology of different positioning templates 10.

[0116] Corresponding to the guide member 20 of the personalized customized part, the dental data collected in step S101 also includes three-dimensional data of the gums; in step S400: the central axis data is matched with the implant axis, and based on the three-dimensional data of the crown and the three-dimensional data of the gums, a three-dimensional model for manufacturing the positioning template is generated; the design method also includes step S500: generating data of the inner side surface 23 of the guide member 20 that matches the outer surface morphology of the gums in the three-dimensional model used to manufacture the positioning template, and combining the data of the inner side surface 23, the reference plane data, and the data of the central axis of the guide tube to design the guide member 20. In this way, the inner side surface 23 of the guide member 20 is designed to change with the actual morphology matching of the outer surface 12 of the positioning template 10, so that the inner side surface 23 and the outer surface 12 of the positioning template 10 can match and fit, thereby stabilizing the position of the guide member 20 and the positioning template 10.

[0117] Furthermore, this embodiment also provides a computer-readable storage medium on which a computer program is stored. When the computer program is executed by a processor, the steps in the design method of the orthodontic anchorage nail implantation auxiliary device 100 described above are implemented.

[0118] Furthermore, referring to FIG. 6 , this embodiment also provides a design system 800 for an orthodontic anchorage nail implantation auxiliary device 100 .

[0119] The design system 800 includes a memory 81 and a processor 82. The memory 81 stores a computer program that can be run on the processor. When the processor 82 executes the computer program, the steps in the design method of the orthodontic anchorage nail implantation auxiliary device 100 described above are implemented.

[0120] Here, in conjunction with the description of the design method of the orthodontic anchorage nail implantation auxiliary device described above, the processor 82 includes the following units:

[0121] An acquisition unit 821 is configured to acquire a digital three-dimensional model of the oral cavity, the digital three-dimensional model comprising three-dimensional data of tooth crowns and three-dimensional data of tooth roots; determine the implantation axis of the anchorage pin based on the three-dimensional data of the tooth roots; and acquire reference surface data of the guide member and central axis data of the guide cylinder;

[0122] The calculation unit 823 matches the central axis data with the implant axis, and generates a three-dimensional model for manufacturing a positioning template based on the three-dimensional data of the crown.

[0123] Of course, the various units of the processor 82 can also be used to execute other steps in the design method of the orthodontic anchorage nail implantation auxiliary device described above, which will not be repeated here.

[0124] Furthermore, referring to FIG. 7 , this embodiment also provides a molding method for an orthodontic anchorage nail implantation auxiliary device 100 , and the molding method includes the following steps.

[0125] S701: preparing a guide member;

[0126] S702: Using the design method for the orthodontic anchorage nail implantation auxiliary device described above, a three-dimensional model for manufacturing a positioning template is generated;

[0127] S703: According to the three-dimensional model for manufacturing the positioning template, a positioning template is formed by using 3D printing technology or membrane hot pressing.

[0128] It can be understood that the auxiliary device 100 introduced above can be formed based on this molding method.

[0129] Among them, step S702 is actually the design method described above, in which when implementing "obtaining the reference plane data of the guide part and the center axis data of the guide tube", the guide part corresponds to the guide part of step S701, that is, at least, the reference plane and the center axis of the guide tube correspond one to one.

[0130] The order of implementation of the various steps in the molding method is not limited to the order described in this application, but is determined by the causal relationship between the steps. For example, if the guide member 20 is implemented as a standard part as described above, step 701 can be implemented before, after, or simultaneously with step S702 and step S703; for another example, if the guide member 20 is implemented as a personalized customized part as described above, step 701 is implemented after step S702, especially after step S500 in the design method described above is implemented, and then the guide member entity is prepared based on the guide member designed in step S500. These changes are all included in the technical purpose defined in this application.

[0131] In this way, the molding method of this embodiment allows the guide member 20 to be universally produced. The position and angle of the mounting surface of the mounting base are adjusted according to the implantation position and implantation angle of the support nails in different cases, and a suitable positioning template is formed using 3D printing technology or diaphragm hot pressing. Not only does the resulting auxiliary device have an excellent implantation guide effect for the support nails and is comfortable and stable to wear, but it also reduces the overall design difficulty, processing cost and difficulty of the auxiliary device, and has excellent industrial value.

[0132] Furthermore, step S701 specifically includes preparing an injection mold for the guide member and molding the guide member using an injection molding process. In other words, the guide member 20 is molded using an injection molding process. Alternatively, in a variant embodiment, step S701 specifically includes molding the guide member using 3D printing technology based on a digital model of the guide member.

[0133] In this embodiment, the forming method further includes step S704: using metal or alloy as the material to be processed, and adopting a machining process to prepare a protective tube 30; and combined with the foregoing, it can be seen that the protective tube 30 matches the guide cylinder 21 of the guide member 20, and the details are not repeated here.

[0134] It is also understandable that the order of implementing step S704 and other steps is not limited to the order described in this application.

[0135] In summary, the present application actually provides an orthodontic anchorage nail implantation auxiliary device 100, as well as a design method, a design system, a molding method and a computer-readable storage medium suitable for the auxiliary device 100.

[0136] Compared with the prior art, the present application has the following beneficial effects: basically, the auxiliary device 100 can assist in limiting the implantation position and implantation angle of the support nail during the support nail implantation surgery, avoid deviation in the implantation position or implantation angle of the support nail, and solve the problem mentioned in the background technology that the direct implantation of the support nail requires higher medical clinical skills; further, on the basis of achieving the aforementioned auxiliary role, the guide member 20 and the positioning template 10 are separately arranged, and the guide member 20 can be at least partially produced as a standard part for universal production. For different cases, it is only necessary to adjust the position and angle of the mounting base 11 that matches the positioning template 10 and the guide member 20, and the positioning template 10 can be designed and formed by a simple method, thereby reducing the design difficulty, processing cost and difficulty of the auxiliary device 100.

[0137] It should be understood that although this specification is described according to embodiments, not every embodiment contains only one independent technical solution. This narrative method of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other implementation methods that can be understood by those skilled in the art.

[0138] The detailed descriptions listed above are merely specific descriptions of feasible implementation methods of the present application. They are not intended to limit the scope of protection of the present application. Any equivalent implementation methods or changes that do not deviate from the technical spirit of the present application should be included in the scope of protection of the present application.

Claims

1. An orthodontic anchorage nail implantation auxiliary device, characterized in that: The auxiliary device comprises: A positioning template for wearing on teeth, the template being provided with a mounting base; and, The guide piece is separately arranged from the template and has a guide end and a fixed end. The guide end is provided with a guide cylinder. The fixed end is mounted on the mounting base. The central axis of the guide cylinder limits the implantation position and angle of the anchor nail.

2. The orthodontic anchorage nail implantation auxiliary device according to claim 1, characterized in that: The template is configured as an invisible brace formed by hot pressing of a membrane.

3. The orthodontic anchorage nail implantation auxiliary device according to claim 1, characterized in that: The mounting base has a mounting surface, and the fixed end of the guide member has a reference surface; The reference surface of the guide member has a standard shape, and the mounting surface of the mounting base has an adapting shape that matches the standard shape; or, the mounting surface of the mounting base has a standard shape, and the reference surface of the guide member has an adapting shape that matches the standard shape; When the fixed end is mounted on the mounting base, the reference surface is in contact with the mounting surface.

4. The orthodontic anchorage nail implantation auxiliary device according to claim 3, characterized in that: The fixed end of the guide member is fixedly or detachably assembled to the mounting base by any of bonding, welding, riveting, and interference fit; or, the template is provided with more than two mounting bases, the reference surface of the guide member matches the morphology of the mounting surface of any of the mounting bases, and the fixed end of the guide member is selectively detachably mounted on any one of the more than two mounting bases.

5. The orthodontic anchorage nail implantation auxiliary device according to claim 4, characterized in that: The reference surface is bonded to the mounting surface by an adhesive.

6. The orthodontic anchorage nail implantation auxiliary device according to claim 3, characterized in that: The guide member is set as a standard member, and the orientation of the mounting surface of the mounting base on the template is designed to change with the implantation position and angle of the support nail, so that when the reference surface of the guide member is in contact with the mounting surface of the mounting base, the central axis of the guide tube of the guide member matches the implantation position and angle of the support nail.

7. The orthodontic anchorage nail implantation auxiliary device according to claim 6, characterized in that: The guide end of the guide member has an inner side surface arranged toward the template, and the inner side surface is designed to change in matching with the actual morphology of the outer surface of the template.

8. The orthodontic anchorage nail implantation auxiliary device according to claim 6, characterized in that: The guide end of the guide member has an inner side surface arranged toward the template, and the inner side surface and the reference surface of the fixed end are arranged in an L shape.

9. The orthodontic anchorage nail implantation auxiliary device according to claim 3, characterized in that: The mounting base is located in the posterior tooth area of ​​the template, and the mounting surface is located at the occlusal surface of the template; or, the mounting base is located in the anterior tooth area of ​​the template and is constructed as an extended flat guide plate structure, and the mounting surface is located on the flat guide plate structure.

10. The orthodontic anchorage nail implantation auxiliary device according to claim 3, characterized in that: The mounting base also has a positioning protrusion protruding from the mounting surface, and the fixed end of the guide member has a positioning recessed hole recessed in the reference surface; when the fixed end is mounted on the mounting base, the positioning protrusion is inserted into the positioning recessed hole.

11. The orthodontic anchorage nail implantation auxiliary device according to claim 10, characterized in that: The number of the positioning protrusions and the number of the positioning recessed holes are at least two, and the two correspond to each other one by one.

12. The orthodontic anchorage nail implantation auxiliary device according to claim 10, characterized in that: The positioning protrusion is interference-fitted into the positioning recessed hole.

13. The orthodontic anchorage nail implantation auxiliary device according to claim 1, characterized in that: The auxiliary device also includes a protection tube inserted in the guide cylinder.

14. The orthodontic anchorage nail implantation auxiliary device according to claim 13, characterized in that: The guide member is configured as an integral injection molded member or a 3D printed resin member, and the protective tube is configured as a metal member or an alloy member.

15. The orthodontic anchorage nail implantation auxiliary device according to claim 13, characterized in that: The guide cylinder comprises a cylindrical main body region and a non-cylindrical end region, and the protection tube comprises a cylindrical tube adapted to the cylindrical main body region and a rotation-stopping tube adapted to the non-cylindrical end region.

16. A design method for an orthodontic anchorage nail implantation auxiliary device, characterized in that: The following steps are involved: Obtain a digital 3D model of the oral cavity; The oral digital three-dimensional model contains three-dimensional data of tooth crowns and three-dimensional data of tooth roots; Based on the three-dimensional data of the tooth root, determine the implantation axis of the anchorage nail; Obtaining the reference surface data of the guide member and the center axis data of the guide cylinder; The central axis data is matched with the implant axis, and based on the three-dimensional data of the crown, a three-dimensional model for manufacturing a positioning template is generated; the three-dimensional model has a mounting surface that matches the morphology of the reference surface.

17. The design method of the orthodontic anchorage nail implantation auxiliary device according to claim 16, characterized in that: The step of "obtaining a digital three-dimensional model of the oral cavity" specifically includes: Collect dental data including three-dimensional data of crowns through intraoral scanner, extraoral scanner or silicone impression; Through oral CBCT equipment, maxillofacial data including three-dimensional data of tooth roots are collected; The dental and maxillofacial data are fitted to obtain a digital three-dimensional model of the oral cavity.

18. The design method of the orthodontic anchorage nail implantation auxiliary device according to claim 17, characterized in that: The oral digital 3D model contains gingival 3D data; In the step of "matching the central axis data with the implant axis, and generating a three-dimensional model for manufacturing a positioning template based on the three-dimensional crown data", a three-dimensional model for manufacturing a positioning template is generated based on the three-dimensional crown data and the three-dimensional gum data; The design method also includes the steps of generating inner side surface data of the guide member that matches the outer surface morphology of the gums in the three-dimensional model used to manufacture the positioning template, and designing the guide member by combining the inner side surface data, the reference surface data and the guide tube centerline data.

19. The method for designing an orthodontic anchorage nail implantation auxiliary device according to claim 16, characterized in that: The three-dimensional model in the step "matching the central axis data with the implant axis, and generating a three-dimensional model for manufacturing a positioning template based on the three-dimensional data of the crown" is specifically set to: a three-dimensional model of the positioning template with the mounting surface, or a three-dimensional model of the tooth with the mounting surface.

20. A computer-readable storage medium having a computer program stored thereon, characterized in that: When the computer program is executed by a processor, the steps in the design method of an orthodontic anchorage nail implantation auxiliary device described in claim 16 are implemented.

21. A design system for an orthodontic anchorage nail implantation auxiliary device, characterized in that: The design system includes a memory and a processor, the memory stores a computer program that can be run on the processor, and when the processor executes the computer program, the steps in the design method of the orthodontic anchorage nail implantation auxiliary device described in claim 16 are implemented.

22. A method for forming an orthodontic anchorage nail implantation auxiliary device, characterized in that: The following steps are involved: preparing guide members; Using the guide as a standard part, the design method of the orthodontic anchorage nail implantation auxiliary device according to claim 16 is adopted to generate a three-dimensional model for manufacturing a positioning template; According to the three-dimensional model used to manufacture the positioning template, the positioning template is formed by adopting 3D printing technology or membrane hot pressing.

23. The molding method of the orthodontic anchorage nail implantation auxiliary device according to claim 22, characterized in that: The step of "preparing the guide member" specifically includes: Preparing an injection mold for the guide member, and molding the guide member using an injection molding process; Alternatively, the guide member is formed by 3D printing technology according to the digital model of the guide member.

24. The molding method of the orthodontic anchorage nail implantation auxiliary device according to claim 22, characterized in that: Also includes the steps: A protective tube is prepared by using metal or alloy as the material to be processed and adopting a machining process; the protective tube matches the guide cylinder of the guide member.

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