Auxiliary instrument assembly for orthognathic surgery of bony class II malocclusion and preparation method of auxiliary instrument assembly

Abstract

The invention provides a bony class II malocclusion orthognathic surgery auxiliary instrument assembly and a preparation method thereof.The osteotomy auxiliary part comprises a fixing and supporting splint and a first positioning guide plate, and an osteotomy positioning groove, a titanium nail positioning hole and a condylar process position indicating hole are formed in the first positioning guide plate; the fixed supporting clamping plate and the first positioning guide plate are connected in a fixed posture through a first connecting rod. The positioning auxiliary component comprises an occlusion clamping plate, a condyle positioning plate and a second positioning guide plate, the condyle positioning plate is attached to the surface of the mandibular branch of the proximal section of the patient and fixedly connected with the mandibular branch of the patient, and a titanium plate positioning frame is arranged in the second positioning guide plate; and the occlusion splint is respectively connected with the condyle positioning plate and the second positioning guide plate in a fixed posture through the second connecting rod and the third connecting rod. According to the invention, the osteotomy auxiliary component and the positioning auxiliary component which are accurately matched with the jaw bone of the patient can be established, so that the positioning and fixing functions of the jaw bone are realized.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an auxiliary device component for orthognathic surgery of skeletal Class II malocclusion and a preparation method thereof. Background Art

[0002] Skeletal Class II malocclusion, also known as Angle Class II malocclusion or distal malocclusion, is a condition in which the development of teeth and maxillofacial bones is not coordinated. Skeletal Class II malocclusion is characterized by maxillary protrusion, mandibular retrusion or both, resulting in abnormal occlusion between the upper and lower teeth, usually manifested as the upper front teeth covering too much of the lower front teeth, or even the lower front teeth cannot contact the upper front teeth when the mouth is closed. For skeletal Class II malocclusion, when orthodontic treatment alone cannot achieve the ideal correction effect, orthognathic surgery is needed to correct the incorrect position relationship between the upper and lower jaws and reposition the upper and lower jaws to the correct position, thereby improving the occlusion relationship and facial appearance.

[0003] When performing orthognathic surgery for skeletal Class II malocclusion, the positions of the osteotomy line and screw fixation holes are determined by visual inspection, and osteotomy and drilling are performed on the osteotomy line and screw fixation holes. This has poor accuracy and makes it difficult to ensure the success and consistency of the surgery. Under the existing technology, even if auxiliary instruments, such as auxiliary positioning devices and auxiliary fixation devices, are provided, different auxiliary instruments are often designed independently, and there is no correlation between the two. The matching degree is poor, and it is difficult to fully adapt to the use of the same patient. In addition, when performing osteotomy and fixation, the operating steps of the auxiliary instruments are complicated. At the same time, conventional auxiliary positioning devices and auxiliary fixation devices also have the problems of poor accuracy and incompatibility with the patient's jaw morphology. Summary of the invention

[0004] The present invention aims to provide an auxiliary instrument component for orthognathic surgery for skeletal Class II malocclusion and a preparation method thereof, so as to solve the technical problems in the prior art that conventional auxiliary instruments can only be used in a certain link of orthognathic surgery for skeletal Class II malocclusion, the correlation and matching between different conventional auxiliary instruments in the same surgical process is poor, the operation is cumbersome and the precision is low.

[0005] In order to solve the above problems, the technical solution of the present invention is: an auxiliary instrument assembly for orthognathic surgery of skeletal Class II malocclusion, comprising: An osteotomy auxiliary component, the osteotomy auxiliary component comprising a fixed support splint and a first positioning guide plate arranged on both sides; The fixed support splint is fixedly connected to the mandibular dentition of the patient; The first positioning guide plate is attached to the outer surface of the patient's mandible in the osteotomy area to be osteotomized. The first positioning guide plate is provided with an osteotomy positioning groove and a plurality of positioning holes, and the osteotomy positioning groove and the positioning holes are respectively in a mapping relationship with the osteotomy line and the screw fixing holes of the patient; The fixed support splint and the first positioning guide plate are connected in a fixed posture through a first connecting rod; A positioning auxiliary component, the positioning auxiliary component includes a bite splint, a condyle positioning plate arranged bilaterally, and a second positioning guide plate; The bite splint is fixedly connected to the patient's mandibular dentition; The condyle positioning plate is attached to the surface of the proximal mandibular ramus of the patient and is fixedly connected to the patient's mandibular ramus; The second positioning guide plate is attached to the osteotomy gap area on the outer surface of the patient's mandible. The second positioning guide plate is provided with a titanium plate positioning frame, and the titanium plate positioning frame is used to indicate the placement position of the titanium plate in the orthognathic surgery for skeletal class II malocclusion; The bite splint is respectively connected to the condyle positioning plate and the second positioning guide plate through a second connecting rod and a third connecting rod to maintain a fixed posture connection. After the titanium plate is placed in the orthognathic surgery for skeletal class II malocclusion, the condyle positioning plate and the titanium plate apply forces from different directions to fix the distal jawbone and the proximal jawbone of the patient.

[0006] Preferably, the fixed support splint is provided with a first cavity adapted to the shape of the patient's mandibular dentition on the side facing the patient's mandibular dentition, and it is defined that when the patient's mandibular dentition is completely located in the first cavity, the relative position between the osteotomy auxiliary component and the patient's mandible is locked; The bite splint is provided with a second cavity adapted to the shape of the patient's mandibular dentition on the side facing the patient's mandibular dentition, and it is defined that when the patient's mandibular dentition is completely located in the second cavity, the relative position between the positioning auxiliary component and the patient's mandible is locked; Moreover, the bite splint is provided with a third cavity adapted to the shape of the patient's maxillary dentition on the side facing the patient's maxillary dentition, and when the patient with skeletal class II malocclusion bites the upper and lower jaws after orthognathic surgery, the patient's maxillary dentition is completely located in the third cavity.

[0007] Preferably, the horizontal first end of the first positioning guide plate extends to the mandibular ramus area of the patient, the horizontal second end of the first positioning guide plate extends to the mandibular body area of the patient, and one end of the first connecting rod is connected to the horizontal second end of the first positioning guide plate; the vertical first end of the first positioning guide plate extends to the lower border of the patient's mandible, and the osteotomy positioning groove extends vertically from the lower border of the patient's mandible for indicating the preset position of the first osteotomy line; The horizontal first end of the second positioning guide plate extends to the area of the patient's proximal jaw bone, and the horizontal second end of the second positioning guide plate extends to the area of the patient's distal jaw bone. One end of the third connecting rod is connected to the horizontal second end of the second positioning guide plate.

[0008] Preferably, the extending direction of the edge of the vertical second end of the first positioning guide plate is set as the osteotomy positioning line, and the osteotomy positioning line is used to indicate the preset position of the second osteotomy line.

[0009] Preferably, the positioning holes include a condyle position indicating hole group and a titanium nail positioning hole group; There are at least two or more condyle position indicating holes in the condyle position indicating hole group, and the condyle position indicating hole group is located at the horizontal first end of the first positioning guide plate; There are at least four or more titanium nail positioning holes in the titanium nail positioning hole group, and the titanium nail positioning holes are arranged symmetrically on both sides along the osteotomy positioning groove.

[0010] Preferably, the diameters of several of the positioning holes are defined as 2 mm; The first connecting rod, the second connecting rod and the third connecting rod are set as curved surface cylinder structures, and the diameters of the first connecting rod, the second connecting rod and the third connecting rod are defined as 5 mm; The width of the osteotomy positioning groove is defined as 1 mm; The thickness of the second positioning guide plate is defined as 2 mm.

[0011] Preferably, the fixed support splint, the first connecting rod and the first positioning guide plate are made by an integral molding process; The occlusal splint, the second connecting rod, the condyle positioning plate, the third connecting rod and the second positioning guide plate are made by an integral molding process.

[0012] Preferably, the titanium plate positioning frame is adapted to the shape and area of the titanium plate used to connect the patient's proximal jaw bone to the distal jaw bone; Moreover, the titanium plate positioning frame includes a plane geometric shape and a curved surface geometric shape.

[0013] Based on the same concept, the present invention also provides a preparation method for an orthognathic surgery auxiliary instrument assembly for skeletal class II malocclusion, which is used to prepare the orthognathic surgery auxiliary instrument assembly for skeletal class II malocclusion as described in any one of the above, and includes the following steps: S11: Scan and obtain the dental arch forms of the patient's mandibular dentition and maxillary dentition through an intraoral scanning instrument; S12: Establish a scanned occlusal splint according to the shapes of the upper and lower dental arches of the patient. The patient wears the scanned occlusal splint, and intraoral CBCT is collected for the patient to obtain the position data of the upper and lower jaws of the patient and the relative position data of the scanned occlusal splint in the patient's mandible. S13: Establish a three-dimensional data model of the patient's upper and lower jaws and the scanned occlusal splint. Based on the occlusal relationship and facial shape requirements of the patient, manually determine the preset positions of the osteotomy line and the screw fixing holes in the three-dimensional data model. S14: According to the preset positions of the osteotomy line and the screw fixing holes, establish a three-dimensional data model of the first positioning guide plate, and according to the relative position of the scanned occlusal splint in the patient's mandible, establish a three-dimensional data model of the first connecting rod. The first connecting rod is used to keep the scanned occlusal splint and the first positioning guide plate in a fixed position and posture. S15: Integrally print and form an osteotomy auxiliary component composed of the scanned occlusal splint, the first positioning guide plate and the first connecting rod. S21: Simulate and analyze the adjustment paths of the distal jaw and the proximal jaw of the patient during the orthognathic surgery for skeletal class II malocclusion, calculate the displacement of the scanned occlusal splint, and establish a three-dimensional data model of the occlusal splint according to the adjusted position data of the patient's upper and lower jaws and the shapes of the upper and lower dental arches. S22: According to the distance between the distal jaw and the proximal jaw of the patient and the preset positions of the screw fixing holes during the orthognathic surgery for skeletal class II malocclusion, design the shape of the titanium plate for fixedly connecting the patient's proximal jaw to the distal jaw, and establish a three-dimensional data model of the second positioning guide plate according to the shape of the titanium plate. S23: According to the preset positions of the screw fixing holes, establish a three-dimensional data model of the condyle positioning plate. S24: According to the relative position of the occlusal splint in the patient's mandible, establish three-dimensional data models of the second connecting rod and the third connecting rod. The second connecting rod and the third connecting rod are used to keep the occlusal splint, the second positioning guide plate and the condyle positioning plate in a fixed position and posture. S25: Integrally print and form a positioning auxiliary component composed of the occlusal splint, the second positioning guide plate, the condyle positioning plate, the second connecting rod and the third connecting rod.

[0014] Preferably, in the osteotomy auxiliary component, a fixed support splint is established according to the scanned occlusal splint, and only the cavity shape of the scanned occlusal splint facing the patient's lower dental arch is retained in the fixed support splint.

[0015] Due to the adoption of the above technical solutions, the present invention has the following advantages and positive effects compared with the prior art: The present invention provides an orthognathic surgery auxiliary instrument assembly for skeletal class II malocclusion and a preparation method thereof. During the preoperative evaluation stage of orthognathic surgery for skeletal class II malocclusion in a patient, an osteotomy auxiliary component and a positioning auxiliary component adapted to the patient before and after orthognathic surgery are established through three-dimensional modeling software. The osteotomy auxiliary component includes a fixed support splint and a first positioning guide plate. The first positioning guide plate is used to indicate the osteotomy position and drilling position during orthognathic surgery for skeletal class II malocclusion through the osteotomy positioning groove and positioning holes provided therein. The positioning auxiliary component includes a bite splint, a condyle positioning plate, and a second positioning guide plate. The condyle positioning plate is used to directly fixedly connect the proximal jawbone and the distal jawbone of the patient along a first direction. The second positioning guide plate is used to indicate the titanium plate placement position during orthognathic surgery for skeletal class II malocclusion through the titanium plate positioning frame provided therein. The titanium plate is used to fixedly connect the proximal jawbone and the distal jawbone of the patient along a second direction. Through the present invention, the osteotomy auxiliary component and the positioning auxiliary component are fully adapted to the jawbone morphology of the patient before and after osteotomy, and there is an excellent correlation and matching degree between the osteotomy auxiliary component and the positioning auxiliary component, so that the functions of osteotomy positioning and osteotomy fixation can be accurately and efficiently assisted. Description of the Drawings

[0016] Figure 1 Schematic structural diagram of the osteotomy auxiliary component provided by the present invention; Figure 2 Schematic structural diagram of the positioning auxiliary component provided by the present invention.

[0017] Description of the reference numerals: 1: osteotomy auxiliary component; 11: fixed support splint; 12: first positioning guide plate; 121: osteotomy positioning groove; 122: osteotomy positioning line; 123: condyle position indicating hole; 124: titanium nail positioning hole; 13: first connecting rod; 2: positioning auxiliary component; 21: bite splint; 22: condyle positioning plate; 23: second positioning guide plate; 231: titanium plate positioning frame; 24: second connecting rod; 25: third connecting rod; 3: first osteotomy line; 4: second osteotomy line. Detailed Embodiments

[0018] The following further details an orthognathic surgery auxiliary instrument assembly for skeletal class II malocclusion and a preparation method thereof proposed by the present invention in conjunction with the accompanying drawings and specific embodiments. The advantages and features of the present invention will be clearer according to the following description and the claims.

[0019] First Embodiment Refer to Figure 1 - Figure 2, this embodiment provides an orthognathic surgery auxiliary instrument assembly for skeletal Class II malocclusion, which is used to assist in positioning the osteotomy line and screw fixation holes during the orthognathic surgery for skeletal Class II malocclusion, and to fix the distal jawbone and the proximal jawbone of the patient after osteotomy. Among them, the auxiliary instrument assembly includes an osteotomy auxiliary component 1 and a positioning auxiliary component 2. The osteotomy auxiliary component 1 is used during the osteotomy process of the orthognathic surgery for skeletal Class II malocclusion, and the positioning auxiliary component 2 is used after the osteotomy of the orthognathic surgery for skeletal Class II malocclusion.

[0020] The osteotomy auxiliary component 1 includes a fixed support splint 11 and two bilaterally arranged first positioning guides 12. The fixed support splint 11 extends along the length direction of the patient's mandibular dentition and can be sleeved on the patient's mandibular dentition to achieve a fixed connection with the patient's mandibular dentition. There are two groups of the first positioning guides 12, which are respectively arranged at the left and right ends of the fixed support splint 11 and the patient's mandibular dentition in the horizontal direction.

[0021] The first positioning guide 12 fits on the outer surface of the patient's mandible in the area to be osteotomized. The first positioning guide 12 is provided with an osteotomy positioning groove 121 and a number of positioning holes. The osteotomy positioning groove 121 and the positioning holes are respectively in a mapping relationship with the osteotomy line and the screw fixation holes to be opened in the patient.

[0022] The fixed support splint 11 and the first positioning guide 12 are fixedly connected in a fixed posture through a first connecting rod 13. After the fixed support splint 11 is fixedly connected to the patient's mandibular dentition, the relative positions of the fixed support splint 11 and the first positioning guide 12 are fixed, that is, the relative position of the first positioning guide 12 and the outer surface of the patient's mandible is fixed. Thus, through the osteotomy positioning groove 121 and the positioning holes, the relative positions of the osteotomy line and the screw fixation holes on the patient's mandible during the operation can be accurately and efficiently determined.

[0023] The positioning auxiliary component 2 includes a bite splint 21, two bilaterally arranged condyle positioning plates 22 and a second positioning guide 23. The bite splint 21 extends along the length directions of the patient's mandibular dentition and maxillary dentition and can be sleeved on the patient's mandibular dentition to achieve a fixed connection with the patient's mandibular dentition. There are two groups of the condyle positioning plates 22 and the second positioning guides 23 respectively, and they are respectively arranged at the left and right ends of the bite splint 21 and the patient's mandibular dentition in the horizontal direction.

[0024] After osteotomy, the condyle positioning plate 22 can fit on the surface of the patient's proximal mandibular ramus. The condyle positioning plate 22 is provided with screw holes, and the condyle positioning plate 22 is fixedly connected to the patient's mandibular ramus by screws passing through its screw holes.

[0025] The second positioning guide plate 23 can be attached to the osteotomy gap area on the outer surface of the patient's mandible after osteotomy. A titanium plate positioning frame 231 is provided in the second positioning guide plate 23, and the titanium plate positioning frame 231 is used to indicate the placement position of the titanium plate during the orthognathic surgery for skeletal class II malocclusion. The titanium plate is provided with screw holes, and the titanium plate is fixedly connected to the distal segment and proximal segment of the patient's jaw bone by screws passing through the screw holes.

[0026] The occlusal splint 21 is fixedly connected to the condyle positioning plate 22 and the second positioning guide plate 23 through the second connecting rod 24 and the third connecting rod 25 to maintain a fixed posture. When the occlusal splint 21 is fixedly connected to the patient's mandibular dentition, the relative positions of the occlusal splint 21, the condyle positioning plate 22, and the second positioning guide plate 23 are fixed, that is, the condyle positioning plate 22 is aligned and fixed with the designated position on the surface of the proximal segment of the patient's mandibular ramus, and the accurate docking of the condyle positioning plate 22 with the patient's mandibular ramus can be achieved. After osteotomy, the relative position of the second positioning guide plate 23 and the osteotomy gap area on the outer surface of the patient's mandible is aligned and fixed. Through the titanium plate positioning frame 231, the specific placement position of the titanium plate in the osteotomy gap area on the outer surface of the patient's mandible can be efficiently positioned.

[0027] In summary, this embodiment provides an orthognathic surgery auxiliary instrument assembly for skeletal class II malocclusion. Before the orthognathic surgery for skeletal class II malocclusion, the osteotomy auxiliary component 1 and the positioning auxiliary component 2 are established according to the upper and lower jaw bone position data of the patient. After the patient wears the osteotomy auxiliary component 1, the first positioning guide plate 12 can be used to indicate the osteotomy position and the screw drilling position. During the osteotomy process of the orthognathic surgery for skeletal class II malocclusion, medical staff control the electric saw tool to cut the patient's mandible along the osteotomy positioning groove 121 in the first positioning guide plate 12, and control the electric drill tool to drill the patient's mandible along several positioning holes in the first positioning guide plate 12. Through the path guiding function of the osteotomy auxiliary component 1, the accuracy and stability of osteotomy and drilling are improved.

[0028] After the osteotomy of the orthognathic surgery for skeletal class II malocclusion is completed and the position of the patient's mandibular body is adjusted, the patient wears the positioning auxiliary component 2. The condyle positioning plate 22 can be used to directly connect the proximal segment and distal segment of the patient's jaw bone, especially the connection between the mandibular ramus and the mandibular body. The second positioning guide plate 23 is used to position the placement position of the titanium plate. Among them, when both ends of the titanium plate are fixedly connected to the proximal segment and distal segment of the patient's jaw bone, the titanium plate is used to connect the proximal segment and distal segment of the patient's jaw bone to keep the patient's jaw bone in a stable posture as a whole.

[0029] It should be noted that in the orthognathic surgery for conventional skeletal Class II malocclusion, the osteotomy line at least includes two segments. One is the first osteotomy line 3 extending vertically upward from the lower border of the patient's mandible, and the other is the second osteotomy line 4 extending obliquely downward from the patient's mandibular angle. The ends of the first osteotomy line 3 and the second osteotomy line 4 are connected, thereby separating the mandible to form an independent proximal segment of the jawbone and a distal segment of the jawbone, and realizing the adjustment of their relative positions. In this embodiment, the titanium plate is arranged in the area of the first osteotomy line 3, that is, the titanium plate is used to fix the proximal segment of the jawbone and the distal segment of the jawbone on both sides of the first osteotomy line 3, while the condyle positioning plate 22 is arranged on the mandibular ramus on the inner side of the second osteotomy line 4, that is, the condyle positioning plate 22 cooperates with the occlusal splint 21 to fix the proximal segment of the jawbone and the distal segment of the jawbone on both sides of the second osteotomy line 4. From the extension directions of the first osteotomy line 3 and the second osteotomy line 4, it can be seen that the titanium plate is used to apply traction to the proximal segment of the jawbone and the distal segment of the jawbone transversely, while the condyle positioning plate 22 is used to apply traction to the proximal segment of the jawbone and the distal segment of the jawbone vertically or obliquely. That is, after the titanium plate is installed in the orthognathic surgery for skeletal Class II malocclusion, the condyle positioning plate 22 and the titanium plate apply forces in different directions to fix the distal segment of the patient's jawbone and the proximal segment of the jawbone, improving the overall connection stability and firmness of the distal segment of the patient's jawbone and the proximal segment of the jawbone at different positions.

[0030] Next, the specific structure and implementation functions of the orthognathic surgery auxiliary instrument assembly provided in this embodiment will be further described in detail: Preferably, in one embodiment, the fixed support splint 11 is provided with a first cavity adapted to the shape of the patient's mandibular dentition on the side facing the patient's mandibular dentition. That is, when the patient's mandibular dentition is completely located in the first cavity, the inner surface of the first cavity of the fixed support splint 11 is completely attached to the surface of the patient's mandibular dentition, and the relative position between the osteotomy auxiliary component 1 and the patient's mandible is locked through the frictional force between the first cavity of the fixed support splint 11 and the patient's mandibular dentition.

[0031] Similarly, the occlusal splint 21 is provided with a second cavity adapted to the shape of the patient's mandibular dentition on the side facing the patient's mandibular dentition. That is, when the patient's mandibular dentition is completely located in the second cavity, the inner surface of the second cavity of the occlusal splint 21 is completely attached to the surface of the patient's mandibular dentition, and the relative position between the positioning auxiliary component 2 and the patient's mandible is locked through the frictional force between the second cavity of the occlusal splint 21 and the patient's mandibular dentition.

[0032] Moreover, the occlusal splint 21 is also provided with a third cavity adapted to the shape of the patient's maxillary dentition on the side facing the patient's maxillary dentition. When the patient's upper and lower jaws bite after the orthognathic surgery for skeletal Class II malocclusion, the patient's maxillary dentition is completely located in the third cavity, enabling the patient to perform normal upper and lower jaw biting movements during the postoperative recovery period.

[0033] It should be noted that, in this embodiment, the material thickness between the second cavity and the third cavity in the occlusal splint 21 adopts the minimum thickness to maximize the imitation of the patient's natural occlusal state.

[0034] Preferably, in one embodiment, the horizontal first end of the first positioning guide plate 12 extends to the mandibular ramus area of the patient, the horizontal second end of the first positioning guide plate 12 extends to the mandibular body area of the patient, and one end of the first connecting rod 13 is connected to the horizontal second end of the first positioning guide plate 12 to shorten the layout length of the first connecting rod 13.

[0035] The vertical first end of the first positioning guide plate 12 extends to the lower border of the patient's mandible, and the osteotomy positioning groove 121 extends vertically from the lower border of the patient's mandible for indicating the preset position of the first osteotomy line 3. When osteotomy is performed along the osteotomy positioning groove 121 from the lower border of the patient's mandible, the cutting path can be clarified, improving the accuracy and portability of the osteotomy operation.

[0036] Meanwhile, the horizontal first end of the second positioning guide plate 23 extends to the proximal segment jaw bone area of the patient, the horizontal second end of the second positioning guide plate 23 extends to the distal segment jaw bone area of the patient, so that the titanium plate layout position delimited by the titanium plate positioning frame 231 can completely cover the proximal segment jaw bone to the distal segment jaw bone of the patient, and one end of the third connecting rod 25 is connected to the horizontal second end of the second positioning guide plate 23 to shorten the layout length of the third connecting rod 25.

[0037] Preferably, in one embodiment, the extending direction of the edge of the vertical second end of the first positioning guide plate 12 is set as the osteotomy positioning line 122, and the osteotomy positioning line 122 is used for indicating the preset position of the second osteotomy line 4, that is, the top edge of the second positioning guide plate 23 is aligned with a partial osteotomy path of the second osteotomy line 4. When osteotomy is performed along the top edge of the second positioning guide plate 23, the cutting path can also be clarified, improving the accuracy and portability of the osteotomy operation.

[0038] Preferably, in one embodiment, the positioning holes of the first positioning guide plate 12 include a condyle position indicating hole group and a titanium nail positioning hole group.

[0039] There are at least two or more condyle position indicating holes 123 in the condyle position indicating hole group, and the condyle position indicating hole group is located at the horizontal first end of the first positioning guide plate 12. Among them, the layout position, aperture size and quantity of the condyle position indicating holes 123 are adapted to the layout position, aperture size and quantity of the screw holes opened in the condyle positioning plate 22.

[0040] There are at least four or more titanium nail positioning holes in the titanium nail positioning hole group, and the titanium nail positioning holes 124 are arranged symmetrically on both sides along the osteotomy positioning groove 121. In one embodiment, the titanium nail positioning hole group is provided with four titanium nail positioning holes 124. The titanium nail positioning holes 124 are grouped in pairs and respectively arranged on both sides of the osteotomy positioning groove 121. And with the osteotomy positioning groove 121 as the axis of symmetry, the four titanium nail positioning holes 124 are arranged symmetrically in pairs. Among them, the arrangement position, hole diameter size and quantity of the titanium nail positioning holes 124 are adapted to the arrangement position, hole diameter size and quantity of the screw holes opened in the titanium plate.

[0041] Preferably, in one embodiment, the diameters of a number of positioning holes, the screw holes in the condyle positioning plate 22 and the screw holes in the titanium plate are all defined as 2 mm.

[0042] The first connecting rod 13, the second connecting rod 24 and the third connecting rod 25 are set as curved columnar structures, and the diameters of the first connecting rod 13, the second connecting rod 24 and the third connecting rod 25 are defined as 5 mm.

[0043] The width of the osteotomy positioning groove 121 is defined as 1 mm.

[0044] The thickness of the second positioning guide plate 23 is defined as 2 mm.

[0045] Preferably, in one embodiment, the fixed support splint 11, the first connecting rod 13 and the first positioning guide plate 12 are made by an integral molding process. The occlusal splint 21, the second connecting rod 24, the condyle positioning plate 22, the third connecting rod 25 and the second positioning guide plate 23 are made by an integral molding process.

[0046] The integral molding process technology includes 3D printing technology, so that the osteotomy auxiliary component 1 and the positioning auxiliary component 2 do not need to be assembled and are integrally formed, having strong structural strength and durability, and can ensure the dimensional and relative position accuracy of each component in the osteotomy auxiliary component 1 and the positioning auxiliary component 2.

[0047] Preferably, in one embodiment, the titanium plate positioning frame 231 is adapted to the shape and area of the titanium plate used to connect the proximal jaw bone to the distal jaw bone of the patient. In the step of placing the titanium plate, the titanium plate can be directly placed in the titanium plate positioning frame 231, and then the alignment of the titanium plate with the corresponding screw fixing holes in the patient's mandible can be completed.

[0048] Moreover, the titanium plate positioning frame 231 includes a planar geometric shape and a curved surface geometric shape. The planar geometric shape means that the geometric shape of the titanium plate positioning frame 231 extends along the planar direction, that is, the corresponding titanium plate used is a straight titanium plate. The curved surface geometric shape means that the geometric shape of the titanium plate positioning frame 231 extends along the curved surface direction, so that the inner wall surface of the titanium plate positioning frame 231 can completely fit the outer surface shape of the patient's mandible. Therefore, the corresponding titanium plate used at this time is a curved titanium plate.

[0049] Second Embodiment Based on the same concept, the present invention also provides a preparation method for an orthognathic surgery auxiliary instrument assembly for skeletal class II malocclusion, which is used to prepare the orthognathic surgery auxiliary instrument assembly for skeletal class II malocclusion as described in any one of the first embodiments, and includes the following steps: S11: Before the orthognathic surgery for skeletal class II malocclusion, scan and obtain the dental arch forms of the patient's mandibular dentition and maxillary dentition through an intraoral scanning instrument.

[0050] S12: Establish a scanning model of the occlusal splint according to the dental arch forms of the patient's upper and lower jaws. The scanning model of the occlusal splint is provided with a fourth cavity adapted to the form of the patient's mandibular dentition on the side facing the patient's mandibular dentition. When the fourth cavity of the scanning model of the occlusal splint is sleeved on the patient's mandibular dentition, the scanning model of the occlusal splint is fixedly connected to the patient's mandibular dentition. At the same time, the scanning model of the occlusal splint is provided with a fifth cavity adapted to the form of the patient's maxillary dentition on the side facing the patient's maxillary dentition. When the patient's upper and lower jaws bite, the patient's maxillary dentition is completely located in the fifth cavity of the scanning model of the occlusal splint. Moreover, the material thickness between the fourth cavity and the fifth cavity in the scanning model of the occlusal splint adopts the minimum thickness, so as to maximize the imitation of the patient's natural occlusal state before the orthognathic surgery for skeletal class II malocclusion and improve the subsequent modeling accuracy of the patient's jaws.

[0051] Subsequently, the patient wears the scanning model of the occlusal splint, and intraoral CBCT is collected for the patient. The shooting range is from the glabella to the submental region, the field of view is 16 cm × 16 cm, and the slice thickness is 0.3 mm. The cranial scan data of the patient is obtained and saved in the DICOM format.

[0052] In the Proplan 3.0 software, import the cranial DICOM scan file obtained by the above shooting, extract the bone data in the CBCT data through the default bone tissue threshold of the system, and perform identification and segmentation processing on the data of the maxilla, mandible, skull, and the scanning model of the occlusal splint, etc., to obtain the position data of the patient's upper and lower jaws and the relative position data of the scanning model of the occlusal splint in the patient's mandible.

[0053] S13: According to the position data of the patient's upper and lower jaws and the relative position data of the scanning model of the occlusal splint in the patient's mandible, establish a three-dimensional data model of the patient's upper and lower jaws and the scanning model of the occlusal splint before the surgery. Based on the patient's upper and lower jaw occlusion relationship and facial shape requirements, manually determine the preset positions of the osteotomy line and screw fixation holes in the patient's mandible in this three-dimensional data model.

[0054] S14: According to the preset positions of the osteotomy line and the screw fixing holes in the patient's mandible, a three-dimensional data model of the first positioning guide plate 12 is established. The first positioning guide plate 12 includes an osteotomy positioning groove 121 corresponding to the position of the osteotomy line and a number of positioning holes corresponding to the positions of the screw fixing holes. Moreover, according to the relative position of the occlusal splint scan in the patient's mandible, the relative positional relationship between the first positioning guide plate 12 and the occlusal splint scan can be determined. Thus, a three-dimensional data model of the first connecting rod 13 is established, including setting parameters such as the length and curvature of the first connecting rod 13. The first connecting rod 13 is used to connect the occlusal splint scan and the first positioning guide plate 12 to keep the occlusal splint scan and the first positioning guide plate 12 in a fixed position and posture. When the occlusal splint scan, the first positioning guide plate 12, and the first connecting rod 13 form the osteotomy assisting component 1, the patient wears the osteotomy assisting component 1. At this time, the osteotomy positioning groove 121 and the number of positioning holes in the first positioning guide plate 12 are completely aligned and coincident with the osteotomy line and the positions of the screw fixing holes simulated in the three-dimensional data models of the patient's upper and lower jaws and the occlusal splint scan before surgery.

[0055] S15: Integrally print and form the osteotomy assisting component 1 composed of the occlusal splint scan, the first positioning guide plate 12, and the first connecting rod 13 through a 3D printing system.

[0056] During the orthognathic surgery for skeletal class II malocclusion, the patient wears the osteotomy assisting component 1. From the osteotomy positioning groove 121 and the number of positioning holes in the first positioning guide plate 12, the positions of the osteotomy line and the screw fixing holes simulated in the three-dimensional data models of the patient's upper and lower jaws and the occlusal splint scan before surgery can be determined. The osteotomy and drilling treatments can be performed according to the indicated positions of the osteotomy line and the screw fixing holes.

[0057] S21: Simulate osteotomy in the Proplan 3.0 software and adjust the relative positions of the distal and proximal segments of the patient's jawbones to adjust the mandibular body of the patient to the postoperative target position. Thus, a three-dimensional data model of the patient's upper and lower jaws and the occlusal splint scan after surgery is established. Simulate and analyze the adjustment paths of the distal and proximal segments of the patient's jawbones during the orthognathic surgery for skeletal class II malocclusion, calculate the rigid transformation parameters (including displacement and rotation amounts) of the occlusal splint scan, and establish a three-dimensional data model of the occlusal splint 21 based on the adjusted position data of the patient's upper and lower jaws, the morphology of the upper and lower dental arches, and the occlusal splint scan.

[0058] The occlusal splint 21 is provided with a second cavity on the side facing the patient's mandibular dentition, which is adapted to the shape of the patient's mandibular dentition. When the second cavity of the occlusal splint 21 is sleeved on the patient's mandibular dentition, the occlusal splint 21 is fixedly connected to the patient's mandibular dentition. At the same time, the occlusal splint 21 is provided with a third cavity on the side facing the patient's maxillary dentition, which is adapted to the shape of the patient's maxillary dentition. When the patient's upper and lower jaws bite, the patient's maxillary dentition is completely located in the third cavity of the occlusal splint scan. Moreover, the material thickness between the second cavity and the third cavity in the occlusal splint 21 adopts the minimum thickness, so that after orthognathic surgery for skeletal class II malocclusion, the patient can achieve natural biting movements.

[0059] S22: According to the distance between the distal segment of the patient's jaw bone and the proximal segment of the jaw bone during orthognathic surgery for skeletal class II malocclusion and the preset positions of the screw fixing holes, design the shape of the titanium plate for fixedly connecting the distal segment of the patient's jaw bone to the proximal segment of the jaw bone, and establish a three-dimensional data model of the second positioning guide plate 23 according to the shape of the titanium plate.

[0060] S23: Establish a three-dimensional data model of the condyle positioning plate 22 according to the preset positions of the corresponding screw fixing holes.

[0061] S24: According to the relative position of the occlusal splint 21 in the patient's mandible, the relative positional relationship between the second positioning guide plate 23 and the condyle positioning plate 22 and the occlusal splint 21 can be determined, and thus a three-dimensional data model of the second connecting rod 24 and the third connecting rod 25 is established, including setting parameters such as the lengths and curvatures of the first connecting rod 13 and the second connecting rod 24. The second connecting rod 24 and the third connecting rod 25 are used to keep the occlusal splint 21, the second positioning guide plate 23 and the condyle positioning plate 22 in fixed positions and postures.

[0062] S25: Integrally print and form the positioning auxiliary component 2 composed of the occlusal splint 21, the second positioning guide plate 23, the condyle positioning plate 22, the second connecting rod 24 and the third connecting rod 25 through a 3D printing system.

[0063] During the orthognathic surgery for skeletal class II malocclusion, after adjusting the distal segment of the patient's jaw bone to the target position, let the patient wear the positioning auxiliary component 2. The condyle positioning plate 22 in the positioning auxiliary component 2 fits on the corresponding position of the patient's mandibular ramus, and the fixed connection between the condyle positioning plate 22 and the patient's mandibular ramus is realized by implanting screws. At the same time, place the titanium plate in the second positioning guide plate 23 of the positioning auxiliary component 2, and realize the fixed connection between the titanium plate and the patient's proximal segment of the jaw bone and the distal segment of the jaw bone by implanting screws.

[0064] Preferably, in one embodiment, in the osteotomy assisting component 1, a fixed support splint 11 is established according to the scanned occlusal splint. The fixed support splint 11 only retains the cavity shape of the scanned occlusal splint facing the patient's mandibular dentition, so as to reduce the preparation cost of the fixed support splint 11 on the premise of realizing all functions of the osteotomy assisting component 1.

[0065] In summary, the present invention provides an orthognathic surgery assisting instrument assembly for skeletal class II malocclusion and its preparation method. In the preoperative evaluation stage of the patient with skeletal class II malocclusion for orthognathic surgery, an osteotomy assisting component 1 and a positioning assisting component 2 adapted to the patient's jaws before and after osteotomy are established through 3D modeling software. The osteotomy assisting component 1 includes a fixed support splint 11 and a first positioning guide plate 12. The first positioning guide plate 12 is used to indicate the osteotomy position and drilling position during orthognathic surgery for skeletal class II malocclusion through the osteotomy positioning grooves 121 and positioning holes provided therein. The positioning assisting component 2 includes an occlusal splint 21, a condylar positioning plate 22 and a second positioning guide plate 23. The condylar positioning plate 22 is used to directly fixedly connect the proximal jawbone of the patient to the distal jawbone along the first direction. The second positioning guide plate 23 is used to indicate the titanium plate placement position during orthognathic surgery for skeletal class II malocclusion through the titanium plate positioning frame 231 provided therein. The titanium plate is used to fixedly connect the proximal jawbone of the patient to the distal jawbone along the second direction. Through the present invention, the osteotomy assisting component 1 and the positioning assisting component 2 are fully adapted to the jawbone shapes of the patient before and after osteotomy, and there is an excellent correlation and matching degree between the osteotomy assisting component 1 and the positioning assisting component 2, so that the functions of osteotomy positioning and osteotomy fixation can be accurately and efficiently assisted.

[0066] The above has described the embodiments of the present invention in detail with reference to the drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, provided that these changes fall within the scope of the claims of the present invention and their equivalent technologies, they still fall within the protection scope of the present invention.

Claims

1. An auxiliary instrument assembly for orthognathic surgery for skeletal Class II malocclusion, characterized in that: include: An osteotomy auxiliary component, the osteotomy auxiliary component comprising a fixed support splint and a first positioning guide plate arranged on both sides; The fixed support splint is fixedly connected to the mandibular dentition of the patient; The first positioning guide plate is attached to the area to be osteotomized on the outer surface of the patient's mandible, and an osteotomy positioning groove and a plurality of positioning holes are provided in the first positioning guide plate, and the osteotomy positioning groove and the positioning holes are respectively mapped to the osteotomy line and the screw fixing hole of the patient; The fixed support clamping plate is connected to the first positioning guide plate in a fixed posture via a first connecting rod; A positioning auxiliary component, the positioning auxiliary component includes an occlusal splint, a condyle positioning plate arranged on both sides, and a second positioning guide plate; The occlusal splint is fixedly connected to the mandibular dentition of the patient; The condylar positioning plate is attached to the surface of the proximal mandibular ramus of the patient and is fixedly connected to the mandibular ramus of the patient; The second positioning guide is attached to the osteotomy gap area on the outer surface of the mandible of the patient, and a titanium plate positioning frame is provided in the second positioning guide, and the titanium plate positioning frame is used to indicate the placement position of the titanium plate during orthognathic surgery for skeletal Class II malocclusion; The occlusal splint is connected to the condyle positioning plate and the second positioning guide plate in a fixed posture via a second connecting rod and a third connecting rod respectively. After the titanium plate is placed during orthognathic surgery for skeletal Class II malocclusion, the condyle positioning plate and the titanium plate apply force from different directions to fix the patient's distal and proximal mandibular segments.

2. The auxiliary instrument assembly for orthognathic surgery for skeletal Class II malocclusion according to claim 1, characterized in that: The fixed support splint is provided with a first cavity adapted to the shape of the patient's mandibular dentition on a side facing the patient's mandibular dentition, and is limited to lock the relative position of the osteotomy auxiliary component and the patient's mandibular bone when the patient's mandibular dentition is completely located in the first cavity; The occlusal splint is provided with a second cavity adapted to the shape of the patient's mandibular dentition on a side facing the patient's mandibular dentition, and is limited to lock the relative position of the positioning auxiliary component and the patient's mandibular bone when the patient's mandibular dentition is completely located in the second cavity; Furthermore, the occlusal splint is provided with a third cavity adapted to the shape of the patient's maxillary dentition on the side facing the patient's maxillary dentition. When the upper and lower jaws of the patient are occluded after orthognathic surgery for skeletal Class II malocclusion, the patient's maxillary dentition is completely located in the third cavity.

3. The auxiliary instrument assembly for orthognathic surgery for skeletal Class II malocclusion according to claim 1, characterized in that: The horizontal first end of the first positioning guide plate extends to the mandibular ramus area of ​​the patient, the horizontal second end of the first positioning guide plate extends to the mandibular body area of ​​the patient, and one end of the first connecting rod is connected to the horizontal second end of the first positioning guide plate; the vertical first end of the first positioning guide plate extends to the lower edge of the mandible of the patient, and the osteotomy positioning groove is vertically extended from the lower edge of the mandible of the patient to indicate the preset position of the first osteotomy line; The horizontal first end of the second positioning guide plate extends to the patient's proximal jaw region, the horizontal second end of the second positioning guide plate extends to the patient's distal jaw region, and one end of the third connecting rod is connected to the horizontal second end of the second positioning guide plate.

4. The auxiliary instrument assembly for orthognathic surgery for skeletal Class II malocclusion as claimed in claim 3, characterized in that: The extending direction of the edge of the first positioning guide plate which is perpendicular to the second end portion is set as the osteotomy positioning line, and the osteotomy positioning line is used to indicate the preset position of the second osteotomy line.

5. The auxiliary instrument assembly for orthognathic surgery for skeletal Class II malocclusion according to claim 1, characterized in that: The positioning holes include a condyle position indication hole group and a titanium nail positioning hole group; The condyle position indicating hole group is provided with at least two or more condyle position indicating holes, and the condyle position indicating hole group is located at the horizontal first end portion of the first positioning guide plate; The titanium nail positioning hole group is provided with at least four or more titanium nail positioning holes which are arranged bilaterally symmetrically along the osteotomy positioning groove.

6. The auxiliary instrument assembly for orthognathic surgery for skeletal Class II malocclusion according to claim 1, characterized in that: The diameter of the plurality of positioning holes is limited to 2 mm; The first connecting rod, the second connecting rod and the third connecting rod are set to a curved cylindrical structure, and the diameters of the first connecting rod, the second connecting rod and the third connecting rod are limited to 5 mm; The width of the osteotomy positioning groove is limited to 1 mm; The thickness of the second positioning guide plate is limited to 2 mm.

7. The auxiliary instrument assembly for orthognathic surgery for skeletal Class II malocclusion according to claim 1, characterized in that: The fixed support clamping plate, the first connecting rod and the first positioning guide plate are made by an integrated molding process; The occlusal splint, the second connecting rod, the condyle positioning plate, the third connecting rod and the second positioning guide plate are made by an integrated molding process.

8. The auxiliary instrument assembly for orthognathic surgery for skeletal Class II malocclusion according to claim 1, characterized in that: The titanium plate positioning frame is adapted to the shape and area of ​​the titanium plate used to connect the proximal jawbone to the distal jawbone of the patient; Furthermore, the titanium plate positioning frame includes a plane geometric shape and a curved surface geometric shape.

9. A method for preparing an auxiliary instrument assembly for orthognathic surgery for skeletal Class II malocclusion, characterized in that: The method for preparing the auxiliary instrument assembly for orthognathic surgery for skeletal Class II malocclusion as claimed in any one of claims 1 to 8 comprises the following steps: S11: Obtain the dental morphology of the patient's mandibular and maxillary dentition through intraoral scanning instruments; S12: creating a bite splint scan according to the upper and lower jaw dentition morphology of the patient, the patient wears the bite splint scan, and performing intraoral CBCT acquisition on the patient to obtain the upper and lower jaw position data of the patient, and the relative position data of the bite splint scan in the mandible of the patient; S13: establishing a three-dimensional data model of the patient's upper and lower jaws and the scanned pieces of the occlusal splint, and manually determining the preset positions of the osteotomy line and the screw fixation holes in the three-dimensional data model based on the upper and lower jaw occlusal relationship and facial shape requirements of the patient; S14: establishing a three-dimensional data model of a first positioning guide plate according to the preset positions of the osteotomy line and the screw fixing holes, and establishing a three-dimensional data model of a first connecting rod according to the relative position of the occlusal splint scan in the mandible of the patient, wherein the first connecting rod is used to keep the occlusal splint scan and the first positioning guide plate in a fixed position and posture; S15: Integrally printing and forming an osteotomy auxiliary component consisting of the occlusal splint scan, the first positioning guide plate and the first connecting rod; S21: Simulate and analyze the adjustment path of the distal and proximal jaws of the patient during orthognathic surgery for skeletal Class II malocclusion, calculate the displacement of the occlusal splint scan, and establish a three-dimensional data model of the occlusal splint based on the adjusted maxillary and mandibular position data and maxillary and mandibular dentition morphology of the patient; S22: According to the distance between the distal and proximal jaws of the patient and the preset position of the screw fixation hole during orthognathic surgery for skeletal Class II malocclusion, the shape of the titanium plate used to fix the proximal jaw to the distal jaw is designed, and the three-dimensional data model of the second positioning guide is established according to the shape of the titanium plate; S23: establishing a three-dimensional data model of the condylar positioning plate according to the preset positions of the screw fixing holes; S24: establishing a three-dimensional data model of a second connecting rod and a third connecting rod according to the relative position of the occlusal splint in the mandible of the patient, wherein the second connecting rod and the third connecting rod are used to keep the occlusal splint, the second positioning guide plate and the condyle positioning plate in a fixed position and posture; S25: Integrally printing and forming a positioning auxiliary component consisting of the occlusal splint, the second positioning guide plate, the condyle positioning plate, the second connecting rod and the third connecting rod.

10. The method for preparing the auxiliary instrument assembly for orthognathic surgery for skeletal Class II malocclusion according to claim 9, characterized in that: In the osteotomy auxiliary component, a fixed support splint is established according to the occlusal splint scan, and the fixed support splint only retains the cavity morphology facing the patient's mandibular dentition in the occlusal splint scan.

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