A two-stage composite guide hole micro-implant anchorage nail precision implant guide plate system

Abstract

The application provides a two-stage composite guide hole micro-implant anchorage nail precise implantation guide plate system, which comprises an auxiliary positioning guide plate and an auxiliary implantation guide plate which can be used independently or in combination, a composite opening structure with a circular positioning hole, a trapezoidal retreat opening and a mucosa incision channel is integrally formed on a device tooth surface retaining structure of the auxiliary positioning guide plate, a guide channel with a cross section of upper rectangle and lower trapezoid is integrally formed on a guide plate tooth surface retaining structure of the auxiliary implantation guide plate, and the implantation precision, operation convenience and intraoperative stability are considered; the auxiliary positioning guide plate can be integrally formed with a hidden orthodontic accessory bonding template. The application solves the defects that the traditional cylindrical channel guide plate cannot consider the precision and operability, the guide plate is easy to be stuck, and the processing is complicated, is suitable for multiple sites in the alveolar bone, vertical or angled multiple types of implantation sites, and reduces the surgical risk and processing cost.

Description

Technical Field

[0001] This invention relates to the field of orthodontic medical device technology, specifically to a two-stage composite guide hole micro-implant anchorage screw precision implantation guide plate system. Background Technology

[0002] The demand for orthodontic treatment in China continues to grow rapidly, with the proportion of complex malocclusion cases steadily increasing. Minimally invasive implant anchorage screws have become a core consumable for achieving precise tooth control and efficient orthodontic treatment in clinical practice, and their clinical application penetration rate has been increasing significantly year by year. With breakthroughs in domestically produced consumable technology and cost reductions, minimally invasive implant anchorage screw technology is rapidly being deployed to primary-level dental institutions, and its application scenarios and the population it covers are continuously expanding.

[0003] The current core clinical pain points are: the implantation of micro-implant anchorage screws is highly dependent on the physician's experience, and insufficient positioning and implantation precision can easily lead to complications such as root damage, nerve exposure, maxillary sinus perforation, and implant loosening and loss, seriously affecting the safety and effectiveness of orthodontic treatment. Both doctors and patients have an increasingly urgent need for more precise implantation, minimally invasive procedures, standardized processes, and controllable risks.

[0004] Crucially, there are currently no digital positioning and assisted implantation guides specifically designed for the characteristics of orthodontic micro-implant anchorage screws. Existing guiding tools are mostly simple modifications of implant (restorative implant) guides or general-purpose simple guides, which are highly mismatched with the mechanical requirements, implantation sites, operating procedures, and anatomical risks of orthodontic micro-implant anchorage screws. They cannot meet the essential need for precise anchorage control in orthodontic clinics, and there is a clear clinical product gap for dedicated precision implantation guides for orthodontic micro-implant anchorage screws.

[0005] Specifically, the current positioning and assistance methods for orthodontic clinical micro-implant anchorage screw implantation are mainly divided into three categories: free hand positioning, two-dimensional image-assisted positioning, and three-dimensional digital positioning and universal implant guide plate assistance.

[0006] First, free-hand positioning (clinical mainstream): Physicians rely on imaging data such as CBCT and panoramic radiographs, combined with intraoral anatomical landmarks and personal experience to determine the implantation site, angle and depth. There is no dedicated positioning and guiding structure, resulting in large human error, high safety risks, and difficulty in achieving precise implantation in complex anatomical areas.

[0007] Second, two-dimensional image-assisted positioning: Based on two-dimensional images, parameters such as bone density and cortical bone thickness are calculated, which can only provide a planar reference. It cannot achieve accurate spatial assessment in the buccal-lingual and mesiodistal directions, and cannot truly reflect the three-dimensional positional relationship between the anchorage screw and the tooth root, nerve, and maxillary sinus, thus the positioning accuracy is limited.

[0008] Third, three-dimensional digital positioning and implant guide assistance: Integrating intraoral scanning and CBCT data for three-dimensional reconstruction and path planning is currently the main technical direction for improving the implantation accuracy of micro-implant anchorage screws. There is already a certain research foundation and patent accumulation for existing digital guidance devices for orthodontic micro-implant anchorage screws, but there is still room for improvement in the following aspects: (1) Existing guides mostly adopt a single cylindrical guide channel with equal cross-section, lacking a graded limiting structure, and precision constraints and operational flexibility cannot be achieved simultaneously; (2) Existing systematic solutions are insufficient, most of which only provide a single guide or a single function, and cannot distinguish between simple and complex cases for tiered adaptation, nor can they form a synergy with the invisible orthodontic system; (3) Existing auxiliary positioning guides are mostly independent 3D printed structures, which cannot be integrated with the invisible orthodontic accessory bonding template for integrated preparation, resulting in high processing costs and cumbersome processes.

[0009] In summary, existing positioning and guiding devices have the following shortcomings: Split-type guides, such as CN114366355A, only use cylindrical guide channels with uniform cross-sections and lack graded limiting structures, making it impossible to simultaneously achieve precision and operational flexibility; single-type guides, such as CN215306848U, can only be used in a single working condition and cannot differentiate between simple and complex cases for tiered adaptation; furthermore, existing positioning devices are mostly independent 3D-printed structures, making it impossible to integrate them with invisible orthodontic accessory templates, resulting in high processing costs and cumbersome procedures. Therefore, there is an urgent clinical need for a digital positioning and assisted implantation guide system specifically designed and optimized for the characteristics of orthodontic micro-implant anchorage screws. Summary of the Invention

[0010] To address the technical problems of existing technologies and universal implant guides, such as insufficient precision and safety, lack of specialized products and poor adaptability, high operational threshold and inefficient process, and disconnect from the orthodontic treatment system, this invention provides a two-stage composite guide hole orthodontic micro-implant anchorage screw precision implantation guide system. By accurately converting and solidifying the implantation site, implantation axis and implantation depth information determined by digital design onto the auxiliary positioning guide and auxiliary implantation guide, the virtual planning data is completely replicated and spatially locked on the physical device. This enables phased and refined control of the positioning and precise implantation of micro-implant anchorage screws, constructing a new micro-implant anchorage screw positioning and auxiliary implantation system as a universal personalized orthodontic auxiliary instrument.

[0011] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0012] A two-stage composite guide hole micro-implant anchorage screw precision implantation guide system includes an auxiliary positioning guide and an auxiliary implantation guide, customized based on the patient's intraoral scan data and CBCT data. The auxiliary positioning guide includes a tooth surface retention structure, on which a composite opening structure is integrally formed. This composite opening structure includes a circular positioning hole, a mucosal incision channel, and a trapezoidal recessed opening communicating with the gingival side of the circular positioning hole. The composite opening structure is used to determine the bone surface implantation site and penetrate the cortical bone surface structure in the first stage of micro-implant anchorage screw implantation. The auxiliary implantation guide includes... The guide plate has an integrally formed composite guide channel on its tooth surface retention structure. The composite guide channel includes a rectangular limiting section with a rectangular upper cross-section and a trapezoidal flaring section with a trapezoidal lower cross-section. The rectangular limiting section restricts the horizontal displacement of the instrument, and the trapezoidal flaring section provides tolerance space for intraoperative angle fine-tuning. The composite guide channel is used for the precise implantation of the second-stage micro-implant anchorage screw in the alveolar bone. The auxiliary positioning guide plate and the auxiliary implantation guide plate can be used alone or in combination. The auxiliary positioning guide plate can be integrally molded with the invisible orthodontic accessory bonding template by compression molding or integrally 3D printing.

[0013] Furthermore, when only the positioning function of the implantation site is required, only the auxiliary positioning guide can be used; when the implantation direction is basically perpendicular to the bone surface and there is no need to cut the mucosa, only the auxiliary implantation guide can be used; otherwise, the auxiliary positioning guide and the auxiliary implantation guide can be used together.

[0014] Furthermore, when the auxiliary positioning guide and the auxiliary implantation guide are used together, the auxiliary positioning guide is first put on, then the cortical bone implantation center point is marked through the circular positioning hole on the auxiliary positioning guide and the mucosa is cut, the micro-implant anchorage nail breaks through the cortical bone surface, and then the auxiliary positioning guide is removed from the micro-implant anchorage nail through the trapezoidal recess. Then the auxiliary implantation guide is put on again, and the micro-implant anchorage nail is inserted into the alveolar bone by rotating along the preset composite guide channel using the implantation driver. After the implantation is completed, the auxiliary implantation guide is removed.

[0015] Furthermore, the diameter of the circular positioning hole in the composite opening structure is equal to or greater than the outer diameter of the micro-implant anchorage nail, the width of the trapezoidal recessed opening is greater than the outer diameter of the micro-implant anchorage nail, and the width of the end connected to the circular positioning hole is smaller; the mucosal incision channel is arranged along the diameter direction of the circular positioning hole and connected to the trapezoidal recessed opening, and the channel length is greater than the diameter of the circular positioning hole.

[0016] Furthermore, when the auxiliary positioning guide is used in conjunction with other devices, it does not have a trapezoidal recess opening. In this case, the micro-implant anchorage screw retracts along the original implantation path after breaking through the cortical bone. When the auxiliary positioning guide is used alone, it is equipped with a trapezoidal recess opening to facilitate the smooth removal of the auxiliary positioning guide from the tooth surface after the micro-implant anchorage screw is implanted into the alveolar bone.

[0017] Furthermore, in the composite guide channel, the upper rectangular limiting section has a height of 4mm and a width of 4.6mm-5.1mm; the lower trapezoidal flared section has a height of 7.5mm, a bottom width of 6.6mm-6.7mm, and a flaring angle of 3°~5°, with a smooth transition between the upper and lower sections.

[0018] Furthermore, the auxiliary implantation guide plate has a connected observation window on the side wall of the composite guide channel for real-time observation of the implantation posture and depth of the micro-implantation anchor nail.

[0019] Furthermore, the auxiliary implantation guide plate is divided into two types: single jaw retention type and occlusal support type.

[0020] Compared with existing technologies, the dual-stage composite guide hole micro-implantation support nail precision implantation guide plate system provided by the present invention has the following beneficial effects:

[0021] 1) Two-stage, layered surgical design to precisely avoid the risk of anatomical damage to tooth roots, nerves, and maxillary sinuses, significantly improving implantation safety: This invention separates the surgical stages into two phases: positioning and intraosseous implantation, each equipped with a functionally differentiated auxiliary positioning guide and auxiliary implantation guide. In the first phase, the auxiliary positioning guide uses a composite opening to lock the unique bone surface implantation site, accurately completing mucosal incision and cortical bone penetration, eliminating the site deviation problems caused by free hands and two-dimensional image positioning. In the second phase, the composite guide channel constrains the spatial deviation of the implantation instrument, replicating the implantation axis and depth planned by three-dimensional digitalization, completely solving the defects of traditional universal implantation guides in poor adaptation to orthodontic micro-interdental spaces and easy contact with tooth roots and nerves, reducing the incidence of clinical complications such as maxillary sinus perforation, tooth root damage, and loosening and dislodgement of anchorage screws from the perspective of the operation process.

[0022] 2) The segmented configuration of the composite guide hole balances high implantation precision with intraoperative operational tolerance, adapting to the stratified diagnosis and treatment needs of complex anatomical cases: The auxiliary positioning guide integrates a circular positioning hole, a mucosal incision channel, and a trapezoidal recessed opening into a single composite opening structure, which can rigidly lock the implantation point; the auxiliary implantation guide adopts a graded composite guide channel with an upper rectangular limiting section and a lower trapezoidal flaring section. The rectangular section strictly limits the horizontal deviation of the instrument in the buccal and lingual, mesial and distal directions to ensure path accuracy, while the 3°~5° inclined trapezoidal flaring section reserves space for minor intraoperative adjustment, solving the contradiction of existing single-channel guides with equal cross-sections that are either too rigid and lack operational tolerance or have too large a tolerance and lose positioning accuracy; at the same time, the two sets of guides can be selected individually or used together. For simple vertical bone surface implantation cases, only the implantation guide is used, while for narrow and complex anatomical areas, both guides are used together, realizing stratified adaptation for cases of varying difficulty and overcoming the limitation of existing single guides that can only adapt to a single working condition.

[0023] 3) The auxiliary positioning guide can be integrated with the invisible orthodontic accessory template, simplifying the entire digital orthodontic process and reducing processing and clinical use costs: Unlike the cumbersome mode of existing independent 3D printed guides that require separate modeling, printing, and clinical wearing, the auxiliary positioning guide of this invention supports integrated molding or 3D printing with the invisible orthodontic accessory bonding template, eliminating the need for additional positioning tooling design. It integrates the two processes of orthodontic accessory manufacturing and anchorage screw implantation positioning; it reduces the time and material costs of digital modeling, 3D printing consumables, and multiple clinical trials, and achieves seamless connection between the anchorage implantation guide and the invisible orthodontic system, solving the industry pain points of traditional guides and orthodontic treatment plans being disconnected and the process being redundant and inefficient. It is especially suitable for grassroots dental institutions to carry out minimally invasive orthodontic anchorage screw implantation surgery in batches.

[0024] 4) The visualization observation window combined with the dual guide plate structure allows for full intraoperative control, lowers the threshold for physician experience, and facilitates the dissemination of technology to primary care facilities: The auxiliary implantation guide plate has a connected observation window on the side wall of the composite guide channel, allowing physicians to observe the implantation posture, insertion depth, and intraosseous fit of the micro-implant anchorage screw in real time during the operation. This overcomes the drawbacks of traditional free-handed methods and guide plates without observation structures, which rely solely on preoperative imaging and cannot be verified in real time during the operation. In addition, the dual-stage guide plate transforms the work of judging the position and controlling the angle, which originally relied heavily on the physician's clinical anatomical experience, into standardized mechanical limiting guidance, greatly reducing the threshold for anchorage screw implantation. Standardized minimally invasive implantation can be completed without the need for senior orthodontists, which meets the industry development needs of disseminating domestically produced micro-implant anchorage screw technology to primary dental institutions.

[0025] 5) The guide plate is miniaturized and modularized, adaptable to the narrow implantation space between orthodontic teeth, facilitating convenient intraoperative operation and unobstructed postoperative removal and insertion: Addressing the specific clinical characteristics of orthodontic micro-implant anchorage screws located in the interdental spaces with limited operating space, this invention employs a lightweight, miniaturized, and personalized molding design for both guide plates, unlike the large-size retention structures of implant guide plates. When used alone, the auxiliary positioning guide plate features a trapezoidal recess opening, allowing for smooth lateral removal of the guide plate after the anchorage screw is screwed into the bone, preventing the screw from obstructing the guide plate and hindering removal. The auxiliary implantation guide plate is divided into two types of retention structures: single-jaw retention and occlusal support. The appropriate type can be flexibly selected based on the patient's dentition defects, crown height, and occlusal status. Stable retention is achieved in both narrow posterior and anterior tooth areas, ensuring unobstructed instrument operation during surgery and significantly improving the smoothness of minimally invasive implantation procedures.

[0026] 6) Complete physical replication of 3D digital planning data eliminates spatial deviations between virtual planning and clinical practice, achieving standardized implementation of implantation parameters: This invention relies on the patient's CBCT + intraoral scan 3D reconstruction data to create two sets of personalized guide plates, solidifying the implantation site, axis, and depth of the preoperative virtual planning into the composite guide hole structure, achieving a 1:1 physical conversion of the virtual surgical path; Compared with the shortcomings of 2D images that can only provide planar references and cannot restore 3D anatomical positions, this invention can accurately lock the 3D safe distance between the anchorage screw and the tooth root, inferior alveolar nerve, and maxillary sinus floor, unifying the implantation standards for different doctors and different treatment scenarios, forming a replicable and standardized micro-implant anchorage screw implantation operation process, and improving the overall stability of orthodontic treatment results.

[0027] 7) The composite mucosal incision channel is integrated into the positioning guide, completing positioning, fixation, and minimally invasive mucosal incision in one step, reducing the number of instrument switching steps during surgery and shortening the operation time: Traditional operation requires first relying on image marking to mark the site, and then changing the incision instrument to fix the mucosa at the point. The multi-step instrument switching can easily cause site displacement; the auxiliary positioning guide of this invention integrates the mucosal incision channel in the diameter direction of the circular positioning hole. After the guide is in place, precise minimally invasive mucosal incision can be completed directly along the channel. Site locking and soft tissue fenestration are achieved simultaneously in one step, reducing the frequency of instrument changing during surgery, shortening the operation time of single-case anchorage nail implantation surgery, reducing the patient's discomfort when opening their mouth during surgery, and improving the minimally invasive diagnosis and treatment experience. Attached Figure Description

[0028] Figure 1 This is a side view of the auxiliary positioning guide plate structure provided by the present invention.

[0029] Figure 2 This is a side view diagram of the single-jaw retention type assisted implantation guide provided by the present invention.

[0030] Figure 3 This is a side view of the occlusal support type auxiliary implantation guide provided by the present invention.

[0031] Figure 4 A schematic diagram of the auxiliary positioning guide plate provided by the present invention in use.

[0032] Figure 5 for Figure 2 Schematic diagram of the cross-sectional structure of the composite guide channel at point A.

[0033] In the figure, 1. Auxiliary positioning guide; 11. Tooth surface retention structure of the device; 12. Circular positioning hole; 13. Mucosal incision channel; 14. Trapezoidal recess opening; 2. Auxiliary implantation guide; 21. Tooth surface retention structure of the guide; 22. Rectangular limiting section; 23. Trapezoidal flaring section; 24. Observation window. Detailed Implementation

[0034] To make the technical means, creative features, objectives and effects of this invention easier to understand, the invention will be further described below with reference to specific illustrations.

[0035] In the description of this invention, it should be understood that the terms "longitudinal," "radial," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing the invention 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 of the invention. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0036] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" 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 or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0037] Please refer to Figures 1 to 5 As shown, this invention provides a dual-stage composite guide hole orthodontic micro-implant anchorage screw precision implantation guide plate system, including two independent tooling sets: an auxiliary positioning guide plate 1 and an auxiliary implantation guide plate 2, which are individually molded based on the patient's CBCT three-dimensional image data and intraoral scan data. The auxiliary positioning guide plate 1 is used for the first stage of micro-implant anchorage screw implantation, completing the bone surface implantation site marking, mucosal incision, and initial puncture breakthrough of the bone cortex. The auxiliary positioning guide plate 1 can be integrally molded with the invisible orthodontic accessory bonding template by compression molding or integrally prepared by 3D printing, realizing the integration of the orthodontic treatment system and the anchorage implantation positioning tooling.

[0038] The auxiliary positioning guide plate 1 includes a device tooth surface retention structure 11, and a composite opening structure integrally formed on the device tooth surface retention structure 11. No additional assembly components are required, which reduces processing materials and simplifies the intraoperative operation process. The composite opening structure consists of three parts: a circular positioning hole 12, a mucosal incision channel 13, and a trapezoidal recessed opening 14, which is different from the single cylindrical through-hole positioning structure of the prior art.

[0039] The diameter of the circular positioning hole 12 is equal to or slightly larger than the outer diameter of the micro-implant anchorage screw, which can rigidly lock the unique bone surface implantation center point, providing a standardized reference point for all implantation operations. The mucosal incision channel 13 is opened in the direction of the diameter of the circular positioning hole. Specifically, the mucosal incision channel 13 is set along the diameter of the circular positioning hole 12 and is connected to the trapezoidal recess opening 14. The length of the mucosal incision channel 13 is slightly larger than the diameter of the circular positioning hole, so that minimally invasive mucosal windowing can be directly completed along this channel. The trapezoidal recess opening 14 is connected to the gingival side of the circular positioning hole and extends to the side, and is only opened when the auxiliary positioning guide 1 is used alone. When used in combination, the trapezoidal recess opening 14 is canceled. The overall width of the trapezoidal recess opening is larger than the outer diameter of the micro-implant anchorage screw, and it narrows near the circular positioning hole to form a recess space. After the micro-implant anchorage screw is completely implanted into the alveolar bone, the auxiliary positioning guide can be smoothly removed laterally, avoiding interference and jamming between the screw body and the edge of the auxiliary positioning guide.

[0040] The entire auxiliary positioning guide plate relies on the tooth surface retention structure 11 of the device to fit the patient's natural tooth surface to achieve stable positioning. Only light pressure is needed to complete the site marking. It is suitable for simple orthodontic cases with flat bone surface, simple anatomical structure and implantation direction perpendicular to the bone surface. When used alone, it can quickly complete site positioning and cortical bone puncture, greatly improving the implantation efficiency of routine cases.

[0041] The auxiliary implantation guide plate 2 is a second-stage precision guiding tooling used for precise intraosseous implantation of the micro-implant anchorage screw after it breaks through the cortical bone. It constrains the axial direction, depth, and buccal / lingual / mesiodistal deviation of the anchorage screw, and is suitable for complex orthodontic cases such as multi-point implantation in the whole jaw, narrow gaps between posterior teeth, uneven bone surfaces, and adjacent tooth roots and maxillary sinuses, so as to achieve precise control of the entire intraosseous implantation process.

[0042] The auxiliary implantation guide plate 2 is provided with a guide plate tooth surface retention structure 21. The guide plate tooth surface retention structure 21 is integrally formed with a composite guide channel. The composite guide channel includes two smoothly transitional sections: the upper part is a rectangular limiting section 22 and the lower part is a trapezoidal flaring section 23. It abandons the traditional single guide hole with equal cross-section cylindrical shape and can be adapted to various specifications of micro implant anchorage screws on the market, making it more versatile.

[0043] The upper rectangular limiting section 22 is 4mm high and its width is controlled between 4.6mm and 5.1mm. The cross-sectional dimensions match the outer diameter of the anchorage nail implantation instrument. It rigidly limits the horizontal displacement of the instrument in the buccal and lingual directions and in the mesiodistal direction, locking the preset implantation path and ensuring implantation accuracy. The lower trapezoidal flaring section 23 is 7.5mm high. Its upper edge width is the same as that of the rectangular limiting section 22, and its bottom width is 6.6mm to 6.7mm. The flaring tilt angle is set to 3° to 5°, forming a gradual flaring tolerance range from top to bottom. This allows the surgeon to make minor adjustments during the operation, offsetting the risk of implantation interference caused by local bone surface anatomical variations and slight hand tremors, and reducing the difficulty of operation in complex cases.

[0044] Meanwhile, the side wall of the composite guide channel has a connected observation window 24, forming an intraoperative visual observation channel. Doctors can observe the screw insertion posture, intraosseous implantation depth, and the fit between the screw and the surrounding bone wall in real time through the window. Implantation deviation can be detected and adjusted in time, eliminating blind operation that may cause damage to the tooth root and nerve, and further improving implantation safety.

[0045] Specific Implementation Example 1: Specifications and Usage of Auxiliary Positioning Guide Plate

[0046] The circular positioning hole 12 with a composite opening structure can be selected from two standard hole diameters: 1.6mm and 2.0mm.

[0047] 1. 1.6mm aperture: Suitable for simple cases requiring strict vertical bone surface implantation and high implantation precision. The hole wall provides stronger restraint, minimizes instrument tilting space, and reduces positioning error.

[0048] 2.0mm aperture: Suitable for vertical bone surface implantation or cases requiring slight angle adjustment, allowing for instrument movement and reducing the probability of instrument rubbing against the hole wall during surgery.

[0049] Clinical selection guidelines: For non-vertical bone surface implantation scenarios, it is not recommended to use the auxiliary positioning guide alone; it is preferable to use it in conjunction with an auxiliary implantation guide. For simple vertical bone surface implantation, the positioning guide can be used alone.

[0050] Specific Implementation Example 2: Adaptation Scenarios of Two Types of Fixation Structures for Assisted Implantation Guide Plates

[0051] The assisted implantation guide plate is available in two structures: single-jaw retention type and occlusal support type. The appropriate type can be selected to suit different clinical conditions.

[0052] 1. Single jaw retention type: The overall structure is simplified and it relies on passive retention through tooth surface occlusion. The surgeon can maintain stability with light pressure during the operation. It is suitable for single jaw local single anchorage screw implantation and cases where patients have abnormal occlusal function and cannot support their bite.

[0053] 2. Occlusal support type: Relying on the patient's natural occlusion to achieve hand-free fixation, the guide plate has stronger overall stability and is suitable for complex surgeries such as simultaneous implantation of multiple anti-screws in the whole jaw and implantation in complex anatomical areas of posterior teeth, reducing the burden on doctors to perform hand fixation operations.

[0054] Specific Implementation Example 3: Composite Guide Channel Dimensions

[0055] like Figure 5The cross-section of the composite guide channel is shown: the upper rectangular limiting section 22 is 4mm high and 4.6mm~5.1mm wide; the lower trapezoidal flared section 23 is 7.5mm high, with the upper edge being the same width as the rectangular section and the bottom width being 6.6mm~6.7mm, and the flare is inclined at 3°~5°; the upper and lower sections are smoothly transitioned without steps, relying on the rectangular section to form a rigid limit to offset hand tremors, and the trapezoidal flare to provide a tolerance range for fine-tuning of the angle, thus taking into account both high precision and operational flexibility.

[0056] Complete Clinical Implementation Process of the Two-Stage Guide Plate System of this Invention

[0057] Step 1: Preoperative sterility check of the guide plate

[0058] The customized auxiliary positioning guide 1 and auxiliary implantation guide 2 are taken out and checked item by item under sterile conditions: the guide is free from deformation, cracks and defects; the circular positioning hole and the composite guide channel are unobstructed throughout; the tooth surface retention structure fits the patient's dental arch model perfectly and does not move or shake after placement; the composite opening and observation window structure are intact and undamaged. Only after passing the inspection can it be used clinically.

[0059] Step 2: First stage – Assisted positioning guide operation (site marking, mucosal incision, cortical bone puncture)

[0060] 1) Guide plate placement and verification of implantation site

[0061] The auxiliary positioning guide 1 is fully fitted to the corresponding dentition area. The finger is used to gently press the tooth surface retention structure 11 of the device to ensure full fit without any movement. The sterile probe is moved down along the circular positioning hole 12 to the surface of the bone cortex. The contact point of the probe tip is repeatedly checked to ensure that it is completely aligned with the preoperative digitally planned implantation site to confirm that the position is not offset.

[0062] 2) Select the guide plate aperture based on the implantation conditions.

[0063] ①Vertical implantation into the bone surface, requiring high precision: 1.6mm diameter circular positioning hole is selected;

[0064] ② For minor angle adjustments and non-flat bone surfaces: use 2.0mm diameter circular positioning holes;

[0065] If the implantation direction is not perpendicular to the bone surface, it is not recommended to use a positioning guide plate alone; a combination of two guide plates is required.

[0066] 3) Initial puncture of the anchorage screw penetrates the cortical bone.

[0067] Align the micro-implant anchorage nail with the implantation instrument and rotate it into the circular positioning hole 12 at a uniform speed until the tip of the anchorage nail pierces the surface of the bone cortex. Maintain the coaxial stability of the instrument throughout the process and avoid lateral shaking or applying excessive pressure.

[0068] 4) Removal of auxiliary positioning guide plate

[0069] When used in conjunction with other devices, the positioning guide plate does not have a trapezoidal recess opening. It is recommended to remove the guide plate after the anchorage nail breaks through the cortical bone layer. After the anchorage nail moves back slightly along the original path, it can be pulled out directly. When used alone, after the anchorage nail is implanted, rely on the trapezoidal recess opening to avoid the implanted anchorage nail structure laterally and gently pull it out. Twisting or bending the guide plate to cause deformation is strictly prohibited.

[0070] Step 3: Second Stage – Precise Intraosseous Implantation with Assisted Implantation Guide

[0071] 1) Assisted implantation guide plate placement and fixation

[0072] The type of guide plate is selected based on the patient's occlusal condition: for normal occlusion, a occlusal support type is preferred; for occlusal disorders, a single-jaw retention type is selected. The guide plate specifications are matched with the anchorage screw model and the positioning guide plate aperture. The guide plate is fully inserted into the tooth surface and adjusted to ensure no mesiodistal or gingival-occlusal displacement, and to ensure that the composite guide channel and the anchorage screw initially punctured remain coaxial.

[0073] The two guide plates correspond to the following stabilization methods:

[0074] ① Single jaw retention type: The physician continuously and evenly applies light pressure to the retention area of ​​the guide plate, keeping the guide plate without displacement throughout the process, and avoiding excessive force that could cause deformation of the guide plate;

[0075] ②Occlusal support type: Guide the patient to bite naturally and achieve passive fixation by relying on their own biting force. During the operation, remind the patient to maintain the biting state and not to open their mouth at will.

[0076] 2) The anchorage screw is precisely screwed into the alveolar bone.

[0077] The implanted actuator is coaxially aligned with the anchorage screw along the composite guide channel and screwed in at a low and uniform speed. The rectangular limiting section restrains the lateral displacement of the device, while the trapezoidal flaring section provides space for slight angle adjustment. If the screwing resistance suddenly increases, the machine should be stopped immediately to check for bone resistance; forced screwing is prohibited. During the operation, the screw depth and implantation angle are continuously monitored in real time through the side wall observation window, and deviations are corrected promptly.

[0078] 3) Remove the guide plate after implantation.

[0079] After confirming through the observation window that the anchorage screw has reached the digitally preset implantation depth, the guide plate is removed: for occlusal support type guide plates, guide the patient to slowly open their mouth and then gently lift it out; for single-jaw retention type guide plates, release the pressing hand and then lift it out straight; twisting or violently pulling the guide plate is prohibited throughout the process to prevent scratching the mucosa, bending the anchorage screw, or causing permanent deformation of the guide plate.

[0080] Typical Application Examples

[0081] Example 1: Simple vertical implantation in the anterior or premolar region (using only an auxiliary positioning guide)

[0082] Case characteristics: clear vision in the anterior or premolar region, wide gaps, smooth bone surface, implantation direction perpendicular to the bone cortex, and no risk to adjacent tooth roots and maxillary sinus.

[0083] Operating procedure: Select a standalone auxiliary positioning guide 1 with a trapezoidal recessed opening. The circular positioning hole 12 has a high-precision diameter of 1.6mm. After the guide is aligned with the anterior tooth surface, the probe marks the center point of the bone surface. Soft tissue windowing is completed along the mucosal incision channel. The anchorage screw is directly screwed in to break through the cortical bone. The guide is removed laterally by relying on the trapezoidal recessed opening. No auxiliary implantation guide is required, simplifying the surgical procedure.

[0084] Example 2: Complex anatomical sites of maxillary posterior teeth (using dual guide plates together)

[0085] Case characteristics: limited field of vision for maxillary posterior teeth, narrow interdental spaces, adjacent to maxillary sinus and tooth roots, and uneven bone surface, requiring strict control of implantation angle and depth.

[0086] Procedure: Select the auxiliary positioning guide 1 without trapezoidal recess opening, with a 2.0mm diameter circular positioning hole; in the first step, after wearing the positioning guide to complete site marking, mucosal incision, cortical bone puncture, retract the anchorage screw and remove the positioning guide; in the second step, wear the occlusal support type auxiliary implantation guide 2, fix the patient's bite, and the actuator moves down along the upper rectangular limiting segment 22, relying on the lower 3°~5° trapezoidal flaring segment to finely adjust the implantation angle. During the operation, the distance between the anchorage screw and the maxillary sinus and tooth root is monitored in real time through the observation window 24, and the screw is accurately implanted to the preset depth.

[0087] Example 3: Integrated Case Preparation for Invisible Orthodontic Treatment

[0088] Case characteristics: Simultaneous invisible orthodontic treatment and simultaneous implantation of orthodontic anchorage screws are required, simplifying the digital processing workflow.

[0089] Processing and Usage Scheme: During the modeling stage, the auxiliary positioning guide plate 1 and the invisible orthodontic accessory bonding template are designed as an integrated unit, which is formed by hot pressing or directly integrated 3D printing; after molding, a circular positioning hole 12 is processed at the preset implantation site, and a trapezoidal recess opening 14 is cut along the gingival side of the hole when used alone; the positioning guide plate and the invisible accessory template are an integral structure, which can be worn simultaneously in clinical practice without the need for separate printing or separate trial fitting positioning fixtures, thus reducing multiple processes such as modeling, printing, and clinical follow-up.

[0090] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A two-stage composite guide hole micro-implantation support pin precision implantation guide plate system, characterized in that, This includes a personalized auxiliary positioning guide and an auxiliary implantation guide based on the patient's intraoral scan data and CBCT data. The auxiliary positioning guide includes a tooth surface retention structure with an integrally formed composite opening structure. The composite opening structure includes a circular positioning hole, a mucosal incision channel, and a trapezoidal recessed opening communicating with the gingival side of the circular positioning hole. This composite opening structure is used to determine the bone surface implantation site and penetrate the cortical bone surface structure in the first stage of micro-implant anchorage screw implantation. The auxiliary implantation guide includes a guide plate tooth surface retention structure with an integrally formed composite guiding channel. This composite guiding channel includes a rectangular limiting segment with a rectangular upper cross-section and a trapezoidal flaring segment with a trapezoidal lower cross-section. The rectangular limiting segment restrains the horizontal deviation of the instrument, and the trapezoidal flaring segment provides tolerance space for intraoperative angle fine-tuning. This composite guiding channel is used for the precise implantation of the micro-implant anchorage screw in the alveolar bone in the second stage. The auxiliary positioning guide and the auxiliary implantation guide can be used alone or in combination. The auxiliary positioning guide plate can be integrally molded or 3D printed with the invisible orthodontic accessory adhesive template.

2. The dual-stage composite guide hole micro-implantation support pin precision implantation guide plate system according to claim 1, characterized in that, When only the positioning function of the implantation site is required, an auxiliary positioning guide can be used alone; when the implantation direction is basically perpendicular to the bone surface and there is no need to cut the mucosa, an auxiliary implantation guide can be used alone; otherwise, an auxiliary positioning guide and an auxiliary implantation guide can be used together.

3. The dual-stage composite guide hole micro-implantation support pin precision implantation guide plate system according to claim 1, characterized in that, When the auxiliary positioning guide and the auxiliary implantation guide are used together, first put on the auxiliary positioning guide, then mark the center point of cortical bone implantation through the circular positioning hole on the auxiliary positioning guide and cut the mucosa. The micro-implant anchorage nail breaks through the surface of the bone cortex. Then, remove the auxiliary positioning guide from the micro-implant anchorage nail through the trapezoidal recess. Then put on the auxiliary implantation guide and use the implantation actuator to rotate and implant the micro-implant anchorage nail into the alveolar bone along the preset composite guide channel. After the implantation is completed, remove the auxiliary implantation guide.

4. The dual-stage composite guide hole micro-implantation support pin precision implantation guide plate system according to claim 1, characterized in that, The diameter of the circular positioning hole in the composite opening structure is equal to or greater than the outer diameter of the micro-implant anchorage nail; the width of the trapezoidal recessed opening is greater than the outer diameter of the micro-implant anchorage nail, and the width of the end connected to the circular positioning hole is smaller; the mucosal incision channel is arranged along the diameter direction of the circular positioning hole and connected to the trapezoidal recessed opening, and the channel length is greater than the diameter of the circular positioning hole.

5. The dual-stage composite guide hole micro-implantation support pin precision implantation guide plate system according to claim 1, characterized in that, When the auxiliary positioning guide is used in conjunction with other devices, it does not have a trapezoidal recess opening. In this case, the micro-implant anchorage screw retracts along the original implantation path after breaking through the cortical bone. When the auxiliary positioning guide is used alone, it is equipped with a trapezoidal recess opening to facilitate the smooth removal of the auxiliary positioning guide from the tooth surface after the micro-implant anchorage screw is implanted into the alveolar bone.

6. The dual-stage composite guide hole micro-implantation support pin precision implantation guide plate system according to claim 1, characterized in that, The upper rectangular limiting section of the composite guide channel has a height of 4mm and a width of 4.6mm-5.1mm; the lower trapezoidal flared section has a height of 7.5mm and a bottom width of 6.6mm-6.7mm, with a flared inclination angle of 3°~5°, and the two sections transition smoothly.

7. The dual-stage composite guide hole micro-implantation support pin precision implantation guide plate system according to claim 1, characterized in that, The auxiliary implantation guide plate has a connected observation window on the side wall of the composite guide channel for real-time observation of the implantation posture and depth of the micro-implantation anchorage nail.

8. The dual-stage composite guide hole micro-implantation support pin precision implantation guide plate system according to claim 1, characterized in that, The auxiliary implantation guide plate is divided into two types: single jaw retention type and occlusal support type.

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