Series of osteotomy guides for condylar osteotomy and their fabrication methods

Abstract

This invention discloses a series of osteotomy guides for condylar osteotomy and their manufacturing method, relating to the field of medical device technology. The manufacturing method includes the following steps: creating a hard plaster dental model; establishing a virtual three-dimensional craniomaxillary model; acquiring virtual dentition data and replacing the dentition data in the three-dimensional model with virtual data; determining the target position of the mandibular bone segment; planning and virtually designing the osteotomy lines for coracoid and condylar resection, and virtually resecting the affected side's coracoid and condylar processes, and virtually designing the affected side's temporomandibular joint reconstruction to obtain a three-dimensional model of the affected side's ascending ramus; drawing the coracoid osteotomy guide; drawing the condylar osteotomy guide based on the mandibular morphology and osteotomy line position; and three-dimensionally printing the guide. By employing the above method, the guide can be fixed using its own shape, eliminating the need for additional fixation measures, reducing the difficulty of the procedure, shortening the operation time, and improving the accuracy of condylar resection; it also reduces the possibility of design errors caused by multi-data matching and fusion during the digital design process.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a series of osteotomy guides for condylar osteotomy and their manufacturing method. Background Technology

[0002] In recent years, digital technology has been widely used in orthognathic surgery. For patients with hemimaxillary hypertrophy, digital data can be collected preoperatively, and the orthognathic surgery can be virtually designed on a computer. Simultaneously, combined with the patient's CT images, the osteotomy line for condyle resection can be determined computationally, and the temporomandibular joint reconstruction plan can be further designed virtually. After the digital plan is designed, the virtual osteotomy plan for condyle resection is translated into the intraoperative method. Currently, two main methods are surgical navigation and surgical guides. Navigation methods have drawbacks such as cumbersome procedures, intraoperative real-time delays, and potential data drift during surgery; therefore, navigation methods are now used relatively less, and surgical guides are more commonly used.

[0003] There are two main types of existing guide plates:

[0004] 1) Extraoral (anterior to the tragus) approach for condylar resection guide plate.

[0005] Based on a virtual orthognathic surgery design for a patient with hemimaxillary hypertrophy, a researcher designed a condylar osteotomy guide suitable for the pretragus approach, taking into account the extent of condylar osteotomy. Using this guide in conjunction with a pre-bent titanium plate, simultaneous orthognathic and condylar resection surgeries were performed. The main drawback of this type of guide is that the pretragus approach results in scarring. Furthermore, since the guide is located at the condylar neck, the contact area between the guide and bone is relatively small; therefore, additional titanium screws are usually required to position the guide for easier surgical execution.

[0006] 2) Intraoral approach condylotomy guide plate.

[0007] Because the surgical field for intraoral condylectomy is relatively small, it demands a high level of clinical experience and surgical skill from the surgeon, thus this type of guide plate is currently rare. One scholar designed a guide plate based on the coracoid guide plate, extending posteriorly from the anterior edge of the ascending ramus and upwards along the medial side of the ascending ramus to the condylar neck. This guide plate is fabricated using 3D printing of titanium, allowing for a very thin profile. However, its contact surface with the jawbone, particularly the anterior edge and medial side of the ascending ramus, is relatively flat, necessitating additional titanium screws for fixation to ensure the guide plate's position conforms to the design. This undoubtedly increases the difficulty of the procedure, prolongs the operation time, and generally results in lower precision in the condylectomy.

[0008] Therefore, it is necessary to design a guide plate for condylectomy that does not require additional fixation, in order to reduce the difficulty of the procedure, shorten the operation time, and improve the precision of condylectomy. Summary of the Invention

[0009] The main objective of this invention is to provide a series of osteotomy guides for condylar osteotomy and a method for manufacturing the same, which aims to reduce the difficulty of the procedure, shorten the operation time, and improve the precision of condylar resection.

[0010] To achieve the above objectives, this invention proposes a method for manufacturing a series of osteotomy guides for condylar osteotomy, wherein the osteotomy guides include a coracoid osteotomy guide and a condylar osteotomy guide, and the manufacturing method includes the following steps:

[0011] Spiral CT scans were performed on the maxillofacial region of the target subject to acquire three-dimensional data of the craniofacial region and teeth, and hard plaster dental models were created.

[0012] The three-dimensional data is imported into craniofacial surgery planning software to create a virtual three-dimensional craniofacial model;

[0013] Laser scanning is used to obtain virtual dentition data from the hard plaster dental model, and this data replaces the dentition data in the three-dimensional data.

[0014] The target surgical type is simulated on the virtual three-dimensional craniomaxillary model, and the target position of the mandibular bone segment is determined based on the terminal occlusion relationship.

[0015] On computed tomography CT images, based on the extent of the condylar lesion, the osteotomy lines for coracoid resection and condylar resection are planned and virtually designed. The coracoid and condylar processes on the affected side are then virtually removed, and the ascending ramus on the affected side is moved upward. Using the condylar remnant, the temporomandibular joint reconstruction on the affected side is virtually designed to obtain a three-dimensional model of the ascending ramus on the affected side.

[0016] Import the virtual three-dimensional craniomaxillary model of the target object and the three-dimensional model file of the affected side ascending ramus into the three-dimensional design software;

[0017] Based on the morphology of the outer surface of the mandibular ramus on the affected side and the position of the coracoid osteotomy line, draw the coracoid osteotomy guide plate with the first target thickness and the first target upper edge width between the anterior edge of the mandibular ramus and the sigmoid notch.

[0018] A Boolean operation is performed between the coracoid osteotomy guide plate and the outer surface of the mandibular ramus to generate the inner surface of the coracoid osteotomy guide plate;

[0019] Based on the morphology of the mandible with the coracoid process removed and the position of the osteotomy line in the condylar osteotomy, draw the condylar osteotomy guide plate with the second target thickness and the second target width.

[0020] A Boolean operation is performed between the condylar osteotomy guide plate and the outer surface of the mandible to generate the inner surface of the condylar osteotomy guide plate;

[0021] The coracoid osteotomy guide plate and the condylar osteotomy guide plate are 3D printed to obtain the osteotomy guide plate.

[0022] Optionally, the step of drawing a coracoid osteotomy guide plate with a first target thickness and a first target upper edge width between the anterior edge of the mandibular ramus and the position of the coracoid osteotomy line based on the outer surface morphology of the affected side's mandibular ramus and the position of the coracoid process osteotomy line specifically includes:

[0023] Based on the morphology of the outer surface of the mandibular ramus on the affected side and the position of the coracoid osteotomy line, a coracoid osteotomy guide plate of the first target thickness is drawn between the anterior edge of the mandibular ramus and the sigmoid notch.

[0024] Align the upper edge of the coracoid osteotomy guide plate with the virtual design of the coracoid osteotomy line, draw the upper edge of the coracoid osteotomy guide plate with the width of the first target upper edge, and ensure that the anterior and posterior edges of the coracoid osteotomy guide plate do not extend to the medial side of the mandibular ramus.

[0025] Optionally, in the step of drawing a coracoid osteotomy guide plate with a first target thickness and a first target upper edge width between the anterior edge of the mandibular ramus and the position of the coracoid osteotomy line based on the outer surface morphology of the mandibular ramus on the affected side and the position of the coracoid osteotomy line, the first target thickness is 0.80-1.20 mm.

[0026] Optionally, in the step of drawing a coracoid osteotomy guide plate with a first target thickness and a first target upper edge width between the anterior edge of the mandibular ramus and the position of the coracoid osteotomy line based on the outer surface morphology of the mandibular ramus on the affected side and the position of the coracoid osteotomy line, the width of the first target upper edge is 0.80-1.20 cm.

[0027] Optionally, the step of drawing a condylar osteotomy guide plate with a second target thickness and a second target width based on the morphology of the mandible with the coracoid process removed and the position of the osteotomy line in the condylar osteotomy specifically includes:

[0028] Based on the morphology of the mandible with the coracoid process removed and the position of the osteotomy line in the condylar osteotomy, starting from the anterior edge of the ascending ramus, the condylar osteotomy guide plate with the second target thickness is drawn posteriorly, covering the coracoid remnant, sigmoid notch and the anterior edge of the condylar neck.

[0029] Position the anterior edge of the condylar osteotomy guide plate at the anterior edge of the mandibular ramus, cover the anterior edge of the condylar neck with its posterior edge, and align the upper edge with the condylar osteotomy line. Draw different portions of the condylar osteotomy guide plate with the second target width.

[0030] Optionally, in the step of drawing a condylar osteotomy guide plate with a second target thickness and a second target width based on the morphology of the mandible with the coracoid process removed and the position of the osteotomy line in the condylar osteotomy, the second target thickness is 0.80-1.20 mm.

[0031] Optionally, in the step of drawing a condylar osteotomy guide plate with a second target thickness and a second target width based on the morphology of the mandible with the coracoid process removed and the position of the osteotomy line in the condylar osteotomy, the second target width is 15-20 mm.

[0032] Optionally, in the step of 3D printing the coracoid osteotomy guide plate and the condylar osteotomy guide plate to obtain the osteotomy guide plate, the materials of the coracoid osteotomy guide plate and the condylar osteotomy guide plate are both resin or nylon.

[0033] Optionally, in the step of simulating the target surgical type on the virtual three-dimensional craniomaxillary model and determining the target position of the mandibular bone segment based on the terminal occlusion relationship, the target surgical type includes Le Fort type I osteotomy and mandibular sagittal splitting.

[0034] To achieve the above objectives, the present invention also proposes an osteotomy guide plate, which is manufactured using the above-described method for manufacturing a series of osteotomy guide plates for condylar osteotomy.

[0035] In the technical solution of the present invention, the method for manufacturing the series of osteotomy guide plates for condylar osteotomy includes the following steps:

[0036] S01. Perform spiral CT scans on the maxillofacial region of the target subject to acquire three-dimensional data of the craniofacial region and teeth, and create hard plaster tooth models.

[0037] S02. Import the three-dimensional data into the craniofacial surgery planning software to establish a virtual three-dimensional craniofacial model;

[0038] S03. Laser scan the hard plaster tooth model to obtain virtual dentition data and replace the dentition data in the three-dimensional data with it;

[0039] S04. Simulate the target surgical type on the virtual three-dimensional craniomaxillary model and determine the target position of the mandibular bone segment based on the terminal occlusion relationship.

[0040] S05. On computed tomography CT images, based on the extent of the condylar lesion, plan and virtually design the osteotomy line for coracoid resection and condylar resection, and virtually resect the coracoid and condylar processes on the affected side. Move the ascending ramus on the affected side upward, and use the condylar remnant to virtually design the temporomandibular joint reconstruction on the affected side to obtain a three-dimensional model of the ascending ramus on the affected side.

[0041] S06. Import the original three-dimensional model of the mandible and the three-dimensional model file of the affected side ascending ramus of the target object into the three-dimensional design software;

[0042] S07. Based on the outer surface morphology of the mandibular ramus on the affected side and the position of the coracoid osteotomy line, draw the coracoid osteotomy guide plate with the first target thickness and the width of the upper edge of the first target between the anterior edge of the mandibular ramus and the sigmoid notch.

[0043] S08. Perform a Boolean operation between the coracoid osteotomy guide plate and the outer surface of the mandibular ramus to generate the inner surface of the coracoid osteotomy guide plate;

[0044] S09. Based on the morphology of the mandible with the coracoid process removed and the position of the osteotomy line in the condylar osteotomy, draw the condylar osteotomy guide plate with the second target thickness and the second target width.

[0045] S10. Perform a Boolean operation between the condylar osteotomy guide plate and the outer surface of the mandible to generate the inner surface of the condylar osteotomy guide plate;

[0046] S11. The coracoid osteotomy guide plate and the condylar osteotomy guide plate are 3D printed to obtain the osteotomy guide plate.

[0047] It is understood that by using the above-mentioned method to manufacture the osteotomy guide plate, the shape of the osteotomy guide plate only needs to be designed based on the surface morphology of the affected mandible, which reduces the possibility of design errors caused by the matching and fusion of multiple data during the digital design process. The guide plate can be fixed by its own shape without the need for additional fixation measures, which reduces the difficulty of the operation, reduces the operation time, and improves the accuracy of condylar resection.

[0048] In this invention, the volume of the osteotomy guide plate and the area it covers in the mandible can be minimized and optimized. The shape design of the guide plate can be completed within the normal surgical dissection range, reducing the possibility of expanding the soft tissue dissection range due to the placement of the guide plate.

[0049] In this invention, the osteotomy guide plate can be securely positioned on the surface of the jawbone simply by its own shape, without the need for additional fixation measures, which facilitates intraoperative operation, while ensuring the intermaxillary fixation force, ensuring secure positioning and easy insertion and removal.

[0050] In this invention, the osteotomy guide plate effectively ensures the accuracy of the osteotomy position and can effectively transfer the preoperative computer-generated surgical plan to the intraoperative implementation.

[0051] The osteotomy guide plate of the present invention is suitable for intraoral approach condylotomy, which avoids incisions in the maxillofacial region and reduces the risk of nerve damage compared to the extraoral approach. Attached Figure Description

[0052] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0053] Figure 1 This is a schematic flowchart of an embodiment of the method for manufacturing a series of osteotomy guide plates for condylar osteotomy according to the present invention;

[0054] Figure 2 This is a schematic diagram of the coracoid osteotomy guide plate at an angle, produced according to an embodiment of the method for manufacturing a series of osteotomy guide plates for condylar osteotomy of the present invention.

[0055] Figure 3 This is a schematic diagram of the coracoid osteotomy guide plate from another angle, based on an embodiment of the method for manufacturing a series of osteotomy guide plates for condylar osteotomy according to the present invention.

[0056] Figure 4 This is a schematic diagram illustrating the application of an angle of a coracoid osteotomy guide plate manufactured according to an embodiment of the method for manufacturing a series of osteotomy guide plates for condylar osteotomy of the present invention.

[0057] Figure 5 This is a schematic diagram of another angle of application of the coracoid osteotomy guide plate manufactured according to one embodiment of the method for manufacturing a series of osteotomy guide plates for condylar osteotomy of the present invention.

[0058] Figure 6 This is a schematic diagram of the structure of a condylar osteotomy guide plate at an angle, produced according to an embodiment of the method for manufacturing a series of osteotomy guide plates for condylar osteotomy of the present invention.

[0059] Figure 7 This is a schematic diagram of the condylar osteotomy guide plate from another angle, which is an embodiment of the method for manufacturing a series of osteotomy guide plates for condylar osteotomy according to the present invention.

[0060] Figure 8 This is a schematic diagram illustrating the application of an angle of a condylar osteotomy guide plate manufactured according to an embodiment of the method for manufacturing a series of osteotomy guide plates for condylar osteotomy of the present invention.

[0061] Figure 9 This is a schematic diagram of another angle showing the application of the condylar osteotomy guide plate manufactured according to one embodiment of the method for manufacturing a series of osteotomy guide plates for condylar osteotomy of the present invention.

[0062] Explanation of icon numbers:

[0063] 100. Coracoid osteotomy guide plate; 200. Condylar osteotomy guide plate.

[0064] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0065] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0066] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indication will also change accordingly.

[0067] In the description of this invention, it should also 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.

[0068] Furthermore, the use of terms such as "first" and "second" in this invention is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. The term "and / or" throughout the text means including three parallel solutions; for example, "A and / or B" includes solution A, solution B, or a solution that simultaneously satisfies A and B. The technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0069] Hemimaxillary hypertrophy is a rare developmental jaw deformity in orthognathic surgery, typically characterized by an enlargement of one mandible in three dimensions. It usually involves the condyle, condylar neck, mandibular ramus, and mandibular body, clearly terminating at the midline symphysis of the chin. A typical hemimaxillary hypertrophy presents with excessive development of the affected mandible, facial rotation and distortion towards the healthy side, chin deviation towards the healthy side, and a downward-arching lower border of the affected mandible. The affected maxilla grows downward alongside the mandible, leading to an inclined occlusal plane and varying degrees of deformity. It can cause temporomandibular joint disorders such as clicking and pain, as well as malocclusion and facial asymmetry. Surgical removal of the hypertrophic condyle is usually required to stop the progression of the deformity.

[0070] The currently accepted treatment for hemimaxillary hypertrophy is combined orthodontic-orthognathic surgery. Most scholars accept the following approach: radionuclide bone scintigraphy is used to determine if condylar resection is indicated. If so, it is performed concurrently with orthognathic surgery. The classic condylar resection procedure involves performing the procedure simultaneously with orthognathic surgery via an anterior transtragus approach. The main advantages of this method are good visualization and a short surgical approach. However, it has disadvantages such as the risk of facial nerve injury, salivary fistula, and residual scarring. Therefore, in recent years, intraoral condylar resection has become increasingly popular. Intraoral condylar resection involves making an approach through the anterior border of the intraoral ascending ramus, removing the ipsilateral coracoid process, further dissecting the soft tissue posteriorly to expose the condylar neck, and then performing the condylar resection. This method has advantages such as leaving no facial scars, preserving a large area of ​​soft tissue attachments around the ascending ramus and condyle, reducing postoperative condylar resorption, and facilitating temporomandibular joint reconstruction in conjunction with bilateral sagittal splitting of the ascending ramus. Its disadvantages include a smaller operating space via the intraoral approach, making precise condylar resection difficult, and a high degree of reliance on the surgeon's experience.

[0071] In recent years, digital technology has been widely used in orthognathic surgery. For patients with hemimaxillary hypertrophy, digital data can be collected preoperatively, and the orthognathic surgery can be virtually designed on a computer. Simultaneously, combined with the patient's CT images, the osteotomy line for condyle resection can be determined computationally, and the temporomandibular joint reconstruction plan can be further designed virtually. After the digital plan is designed, the virtual osteotomy plan for condyle resection is translated into the intraoperative method. Currently, two main methods are surgical navigation and surgical guides. Navigation methods have drawbacks such as cumbersome procedures, intraoperative real-time delays, and potential data drift during surgery; therefore, navigation methods are now used relatively less, and surgical guides are more commonly used.

[0072] There are two main types of existing guide plates:

[0073] 1) Extraoral (anterior to the tragus) approach for condylar resection guide plate.

[0074] Based on a virtual orthognathic surgery design for a patient with hemimaxillary hypertrophy, a researcher designed a condylar osteotomy guide suitable for the pretragus approach, taking into account the extent of condylar osteotomy. Using this guide in conjunction with a pre-bent titanium plate, simultaneous orthognathic and condylar resection surgeries were performed. The main drawback of this type of guide is that the pretragus approach results in scarring. Furthermore, since the guide is located at the condylar neck, the contact area between the guide and bone is relatively small; therefore, additional titanium screws are usually required to position the guide for easier surgical execution.

[0075] 2) Intraoral approach condylotomy guide plate.

[0076] Because the surgical field for intraoral condylectomy is relatively small, it demands a high level of clinical experience and surgical skill from the surgeon, thus this type of guide plate is currently rare. One scholar designed a guide plate based on the coracoid guide plate, extending posteriorly from the anterior edge of the ascending ramus and upwards along the medial side of the ascending ramus to the condylar neck. This guide plate is fabricated using 3D printing of titanium, allowing for a very thin profile. However, its contact surface with the jawbone, particularly the anterior edge and medial side of the ascending ramus, is relatively flat, necessitating additional titanium screws for fixation to ensure the guide plate's position conforms to the design. This undoubtedly increases the difficulty of the procedure, prolongs the operation time, and generally results in lower precision in the condylectomy.

[0077] In response, this invention proposes a method for manufacturing a series of osteotomy guide plates for condylar osteotomy, and studies a guide plate for condylar resection that does not require additional fixation, so as to reduce the difficulty of the operation, reduce the operation time, and improve the accuracy of condylar resection.

[0078] Reference Figures 1 to 9 In some embodiments of the present invention, the osteotomy guide plate includes an integrally formed coracoid osteotomy guide plate 100 and an integrally formed condylar osteotomy guide plate 200. The method for manufacturing a series of osteotomy guide plates for condylar osteotomy includes the following steps:

[0079] S01. Perform spiral CT scans on the maxillofacial region of the target subject to acquire three-dimensional data of the craniofacial region and teeth, and create hard plaster tooth models.

[0080] In this step, a CT scan is performed on the target subject before surgery to collect three-dimensional data of the craniofacial region and teeth. A hard plaster tooth model is then created to prepare for obtaining three-dimensional virtual tooth data of the patient.

[0081] S02. Import the three-dimensional data into the craniofacial surgery planning software to create a virtual three-dimensional craniofacial model.

[0082] In this step, the three-dimensional CT data of the cranium and teeth obtained after CT scanning can be imported into the craniofacial surgery planning software in DICOM format. The software can then use the imported data to create a virtual three-dimensional craniofacial model of the patient.

[0083] For craniofacial surgery planning software, you can specifically choose CCMFPlan V1.0 craniofacial surgery planning software from a certain company.

[0084] S03. Laser scanning of hard plaster dental models to obtain virtual dentition data, and then replacing the dentition data in the three-dimensional data with it.

[0085] In this step, the prepared hard plaster tooth model can be placed on the platform of a 3D laser scanning device for multi-dimensional and multi-angle 3D scanning. This allows for the acquisition of more accurate dentition data of the hard plaster tooth model, which is then saved in STL format and used to replace the dentition data in the CT data.

[0086] S04. Simulate the target surgical type on a virtual three-dimensional craniomaxillary model and determine the target location of the mandibular bone segment based on the terminal occlusal relationship.

[0087] The target surgical types include Le Fort type I osteotomy and mandibular sagittal splitting, but are not limited here.

[0088] In this step, Le Fort I osteotomy of the maxilla and sagittal split of the mandible can be simulated on a virtual craniomaxillary model. The maxillary bone segment is moved to the target position according to the surgical plan, and then the target position of the mandibular bone segment is determined based on the final occlusal relationship.

[0089] Determining this target position is a fundamental and crucial step in orthognathic surgery, referring to the postoperative mandibular position corresponding to the original mandibular position. The guides in this invention are all designed based on the original mandibular position and used during surgery based on that position.

[0090] S05. On computed tomography CT images, based on the extent of the condylar lesion, plan and virtually design the osteotomy line for coracoid resection and condylar resection, and virtually resect the coracoid and condylar processes on the affected side. Move the ascending ramus on the affected side upward, and use the condylar remnant to virtually design the temporomandibular joint reconstruction on the affected side to obtain a three-dimensional model of the ascending ramus on the affected side.

[0091] S06. Import the original three-dimensional model of the mandible and the three-dimensional model of the affected side's ascending ramus of the target object into the three-dimensional design software.

[0092] In this step, the original three-dimensional model of the mandible and the three-dimensional model of the ascending ramus on the affected side are the STL files mentioned above.

[0093] For 3D design software, you can choose FreeForm V11.0 from a certain company.

[0094] S07. Based on the outer surface morphology of the mandibular ramus on the affected side and the position of the coracoid osteotomy line, draw a coracoid osteotomy guide plate 100 with the first target thickness and the first target upper edge width between the anterior edge of the mandibular ramus and the sigmoid notch.

[0095] In order to minimize and optimize the volume of the coracoid osteotomy guide plate 100, reduce surgical trauma, and ensure the overall strength of the guide plate, the thickness of the first target can be 0.80-1.20 mm, preferably 1 mm; the width of the upper edge of the first target can be 0.80-1.20 cm, preferably 1 cm, but is not limited here.

[0096] This step may specifically include:

[0097] Based on the morphology of the outer surface of the mandibular ramus on the affected side and the position of the coracoid osteotomy line, a coracoid osteotomy guide plate 100 with the first target thickness is drawn between the anterior edge of the mandibular ramus and the sigmoid notch.

[0098] Align the upper edge of the coracoid osteotomy guide plate 100 with the virtual coracoid osteotomy line, draw the upper edge of the coracoid osteotomy guide plate 100 with the width of the first target upper edge, and ensure that the anterior and posterior edges of the coracoid osteotomy guide plate 100 do not extend to the medial side of the mandibular ramus.

[0099] In this embodiment, the anterior and posterior edges of the coracoid osteotomy guide plate 100 do not extend to the medial side of the mandibular ramus, which effectively ensures the smooth placement and removal of the guide plate. In this embodiment, the coracoid osteotomy guide plate 100 is designed based on the position of the ipsilateral molar and the coracoid osteotomy line, resulting in a more reasonable and reliable structure.

[0100] S08. Perform a Boolean operation between the coracoid osteotomy guide plate 100 and the outer surface of the mandibular ramus to generate the inner surface of the coracoid osteotomy guide plate 100.

[0101] It should be noted that Boolean operations are a logical deduction method based on numerical symbols, including union, intersection, and subtraction. This logical operation method is used in graphics processing to create new shapes by combining simple basic graphics, and has evolved from two-dimensional Boolean operations to three-dimensional Boolean operations.

[0102] The outer surface of the coracoid osteotomy guide plate 100 is drawn using the aforementioned three-dimensional design software.

[0103] S09. Based on the morphology of the mandible with the coracoid process removed and the position of the osteotomy line in the condylar osteotomy, draw the condylar osteotomy guide plate 200 with the second target thickness and the second target width.

[0104] In order to minimize and optimize the volume of the condylar osteotomy guide plate 200, reduce surgical trauma, and ensure the overall strength of the guide plate, the thickness of the second target can be 0.80-1.20 mm, preferably 1 mm; the width of the second target is 15-20 mm, which is not limited here.

[0105] This step may specifically include:

[0106] Based on the morphology of the mandible with the coracoid process removed and the position of the osteotomy line in the condylar osteotomy, starting from the anterior edge of the ascending ramus, and covering the coracoid process stump, sigmoid notch and the anterior edge of the condylar neck, draw a condylar osteotomy guide plate 200 with a second target thickness.

[0107] Position the anterior edge of the condylar osteotomy guide plate 200 at the anterior edge of the mandibular ramus, the posterior edge covering the anterior edge of the condylar neck, and the superior edge aligned with the condylar osteotomy line. Draw different sections of the condylar osteotomy guide plate 200 with the second target width.

[0108] In this embodiment, a condylar osteotomy guide plate is designed based on the shape of the ascending ramus after coracoid process resection and the position of the condylar osteotomy line. The condylar osteotomy guide plate 200 has a more reasonable structure, is easy to install, and does not require fixation with titanium screws or the like.

[0109] S10. Perform a Boolean operation between the condylar osteotomy guide plate 200 and the outer surface of the mandible to generate the inner surface of the condylar osteotomy guide plate 200.

[0110] In this embodiment, the outer surface of the condylar osteotomy guide plate 200 is drawn using the aforementioned three-dimensional design software.

[0111] S11. A three-dimensionally printed coracoid osteotomy guide plate 100 and a condylar osteotomy guide plate 200 are used to prepare the osteotomy guide plate.

[0112] Both the coracoid osteotomy guide plate 100 and the condylar osteotomy guide plate 200 can be made of resin or nylon. Resin or nylon has a certain degree of elasticity and toughness, which facilitates intraoperative manipulation, ensures stable placement, and makes them easy to put on and take off.

[0113] In this step, the final guide plate data drawn and generated by the software is imported into the 3D printing equipment for 3D printing, thereby completing the production of the guide plate.

[0114] It is understood that by using the above-mentioned method to manufacture the osteotomy guide plate, the shape of the osteotomy guide plate only needs to be designed based on the surface morphology of the affected mandible, which reduces the possibility of design errors caused by the matching and fusion of multiple data during the digital design process. The guide plate can be fixed by its own shape without the need for additional fixation measures, which reduces the difficulty of the operation, reduces the operation time, and improves the accuracy of condylar resection.

[0115] The osteotomy guide plate of the present invention is suitable for intraoral approach condylotomy, which avoids incisions in the maxillofacial region and reduces the risk of nerve damage compared to the extraoral approach.

[0116] In this invention, the volume of the osteotomy guide plate and the area it covers in the mandible can be minimized and optimized. The shape design of the guide plate can be completed within the normal surgical dissection range, reducing the possibility of expanding the soft tissue dissection range due to the placement of the guide plate.

[0117] In this invention, the osteotomy guide plate can be securely positioned on the surface of the jawbone simply by its own shape, without the need for additional fixation measures, which facilitates intraoperative operation, while ensuring the intermaxillary fixation force, ensuring secure positioning and easy insertion and removal.

[0118] The osteotomy guide plate of the present invention effectively ensures the accuracy of the osteotomy position and can effectively transfer the preoperative computer-generated surgical plan to the intraoperative implementation.

[0119] It should also be noted that in the clinical implementation of intraoral condylar resection, under general anesthesia with intubation, an incision is made in the mandibular vestibule and anterior border of the ramus on the affected side. The anterior border of the ramus and the root of the coracoid process are exposed. The coracoid process is removed using a 100mm coracoid osteotomy guide plate. The cut coracoid process is then pushed upwards, and the condylar neck is exposed by posterior dissection along the sigmoid notch. The joint capsule attachment is separated, and the condylar osteotomy line is determined using a 200mm condylar osteotomy guide plate. After completing the maxillary Le Fort I osteotomy and the contralateral sagittal split of the ramus, the condyle is cut and removed according to the condylar osteotomy line, followed by the ipsilateral sagittal split of the ramus and genioplasty.

[0120] The present invention also proposes an osteotomy guide plate, referring to Figures 2 to 9 The osteotomy guide plate includes an integrally formed coracoid osteotomy guide plate 100 and an integrally formed condylar osteotomy guide plate 200. The osteotomy guide plate is manufactured using the above-described method for manufacturing a series of osteotomy guide plates for condylar osteotomy. Since the osteotomy guide plate proposed in this invention is based on all embodiments of the above-described manufacturing method, it has at least the same technical effects as the above-described manufacturing method, which will not be elaborated here.

[0121] The present invention also provides a computer device that can be directly or indirectly electrically connected to all the devices or apparatuses that can be controlled by signals involved in the above-described method for manufacturing a series of osteotomy guide plates for condylar osteotomy, or the computer device can be composed of the host of one of the devices or apparatuses used in the above-described method. This computer device is used to control the operation of each device or apparatus and execute relevant manufacturing steps to automatically complete the manufacturing of the guide plates.

[0122] The computer device includes one or more processors, memory, and interfaces for connecting the components, including high-speed interfaces and low-speed interfaces. The components communicate with each other using different buses and can be mounted on a common motherboard or otherwise installed as needed. The processor can process instructions executed within the computer device, including instructions stored in or on memory to display graphical information of a GUI on an external input / output device (such as a display device coupled to the interface). In some embodiments, multiple processors and / or multiple buses can be used with multiple memories and multiple memory modules, if desired. Similarly, multiple computer devices can be connected, each providing some of the necessary operations (e.g., as a server array, a group of blade servers, or a multiprocessor system).

[0123] The processor can be a central processing unit, a network processor, or a combination thereof. The processor may further include hardware chips. These hardware chips can be application-specific integrated circuits (ASICs), programmable logic devices (PLDs), or combinations thereof. The programmable logic devices can be complex programmable logic devices (CLPs), field-programmable gate arrays (FPGAs), general-purpose array logic (GDAs), or any combination thereof.

[0124] The memory stores instructions executable by at least one processor to enable the at least one processor to perform a method for manufacturing a series of osteotomy guides for condylar osteotomy as shown in the above embodiments.

[0125] The memory may include a stored program area and a stored data area, wherein the stored program area may store the operating system and application programs required for at least one function; the stored data area may store data created based on the use of the computer device, etc. Furthermore, the memory may include high-speed random access memory, and may also include non-transitory memory, such as at least one disk storage device, flash memory device, or other non-transitory solid-state storage device. In some embodiments, the memory may include memory remotely located relative to the processor, and these remote memories may be connected to the computer device via a network. Examples of such networks include, but are not limited to, the Internet, corporate intranets, local area networks, mobile communication networks, and combinations thereof.

[0126] The memory may include volatile memory, such as random access memory; the memory may also include non-volatile memory, such as flash memory, hard disk or solid-state drive; the memory may also include a combination of the above types of memory.

[0127] The computer device also includes input and output devices. The processor, memory, input and output devices can be connected via a bus or other means.

[0128] Input devices can receive input numerical or character information and generate key signal inputs related to user settings and function control of the computer device, such as touchscreens, keypads, mice, trackpads, touchpads, joysticks, one or more mouse buttons, trackballs, joysticks, etc. Output devices may include display devices, auxiliary lighting devices (e.g., LEDs), and haptic feedback devices (e.g., vibration motors). The aforementioned display devices include, but are not limited to, liquid crystal displays, light-emitting diodes, displays, and plasma displays. In some embodiments, the display device may be a touchscreen.

[0129] The present invention also provides a computer-readable storage medium in which the method for manufacturing a series of osteotomy guides for condylar osteotomy according to embodiments of the present invention can be implemented in hardware or firmware, or implemented as computer code that can be recorded on a storage medium, or implemented as computer code downloaded via a network and originally stored on a remote storage medium or a non-transitory machine-readable storage medium and then stored on a local storage medium. Thus, the method described herein can be processed by software stored on a storage medium using a general-purpose computer, a dedicated processor, or programmable or dedicated hardware. The storage medium can be a magnetic disk, optical disk, read-only memory, random access memory, flash memory, hard disk, or solid-state drive, etc.; further, the storage medium can also include combinations of the above types of memory. It is understood that a computer, processor, microprocessor controller, or programmable hardware includes a storage component capable of storing or receiving software or computer code, which, when accessed and executed by the computer, processor, or hardware, implements the method shown in the above embodiments.

[0130] The above description is merely an optional embodiment of the present invention and does not limit the patent scope of the present invention. All equivalent structural transformations made using the contents of the present invention's specification and drawings under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

Claims

1. A method for manufacturing a series of osteotomy guides for condylar osteotomy, wherein the osteotomy guides include a coracoid osteotomy guide and a condylar osteotomy guide, characterized in that, The manufacturing method includes the following steps: Spiral CT scans were performed on the maxillofacial region of the target subject to acquire three-dimensional data of the craniofacial region and teeth, and hard plaster dental models were created. The three-dimensional data is imported into craniofacial surgery planning software to create a virtual three-dimensional craniofacial model; Laser scanning is used to obtain virtual dentition data from the hard plaster dental model, and this data replaces the dentition data in the three-dimensional data. The target surgical type is simulated on the virtual three-dimensional craniomaxillary model, and the target position of the mandibular bone segment is determined based on the terminal occlusion relationship. On computed tomography CT images, based on the extent of the condylar lesion, the osteotomy lines for coracoid resection and condylar resection are planned and virtually designed. The coracoid and condylar processes on the affected side are then virtually removed, and the ascending ramus on the affected side is moved upward. Using the condylar remnant, the temporomandibular joint reconstruction on the affected side is virtually designed to obtain a three-dimensional model of the ascending ramus on the affected side. Import the virtual three-dimensional craniomaxillary model of the target object and the three-dimensional model file of the affected side ascending ramus into the three-dimensional design software; Based on the morphology of the outer surface of the mandibular ramus on the affected side and the position of the coracoid osteotomy line, a coracoid osteotomy guide plate with a first target thickness is drawn between the anterior edge of the mandibular ramus and the sigmoid notch; the upper edge of the coracoid osteotomy guide plate is aligned with the virtual coracoid osteotomy line, and the upper edge of the coracoid osteotomy guide plate with a first target upper edge width is drawn, and the anterior and posterior edges of the coracoid osteotomy guide plate do not extend to the medial side of the mandibular ramus; A Boolean operation is performed between the coracoid osteotomy guide plate and the outer surface of the mandibular ramus to generate the inner surface of the coracoid osteotomy guide plate; Based on the morphology of the mandible with the coracoid process removed and the position of the osteotomy line in the condylar osteotomy, starting from the anterior edge of the ascending ramus, the condylar osteotomy guide plate with a second target thickness is drawn posteriorly, covering the coracoid remnant, sigmoid notch, and anterior edge of the condylar neck. The anterior edge of the condylar osteotomy guide plate is positioned at the anterior edge of the ascending ramus of the mandible, the posterior edge covers the anterior edge of the condylar neck, and the superior edge is aligned with the condylar osteotomy line. Different parts of the condylar osteotomy guide plate with a second target width are then drawn. A Boolean operation is performed between the condylar osteotomy guide plate and the outer surface of the mandible to generate the inner surface of the condylar osteotomy guide plate; The coracoid osteotomy guide plate and the condylar osteotomy guide plate are 3D printed to obtain the osteotomy guide plate.

2. The method for manufacturing the series of osteotomy guides for condylar osteotomy as described in claim 1, characterized in that, In the step of drawing a coracoid osteotomy guide plate with a first target thickness between the anterior edge of the mandibular ramus and the position of the coracoid osteotomy line based on the outer surface morphology of the mandibular ramus and the position of the coracoid osteotomy line on the affected side; drawing the upper edge of the coracoid osteotomy guide plate with the first target upper edge width, aligning the upper edge of the coracoid osteotomy guide plate with the virtually designed coracoid osteotomy line, and ensuring that the anterior and posterior edges of the coracoid osteotomy guide plate do not extend to the medial side of the mandibular ramus, the first target thickness is 0.80-1.20 mm.

3. The method for manufacturing a series of osteotomy guides for condylar osteotomy as described in claim 1 or 2, characterized in that, In the step of drawing a coracoid osteotomy guide plate with a first target thickness between the anterior edge of the mandibular ramus and the position of the coracoid osteotomy line based on the outer surface morphology of the mandibular ramus and the position of the coracoid osteotomy line on the affected side; and drawing the upper edge of the coracoid osteotomy guide plate with a first target upper edge width, aligning the upper edge of the coracoid osteotomy guide plate with the virtually designed coracoid osteotomy line, and ensuring that the anterior and posterior edges of the coracoid osteotomy guide plate do not extend to the medial side of the mandibular ramus, the width of the first target upper edge is 0.80-1.20 cm.

4. The method for manufacturing the series of osteotomy guides for condylar osteotomy as described in claim 1, characterized in that, In the step of drawing a condylar osteotomy guide plate with a second target thickness, based on the morphology of the mandible with the coracoid process removed and the position of the osteotomy line for condylar osteotomy, starting from the anterior edge of the ascending ramus and extending posteriorly to cover the coracoid process remnant, sigmoid notch, and anterior edge of the condylar neck; and in the step of drawing different parts of the condylar osteotomy guide plate with a second target width, with the anterior edge of the condylar osteotomy guide plate located at the anterior edge of the ascending ramus, the posterior edge covering the anterior edge of the condylar neck, and the upper edge aligned with the condylar osteotomy line, the second target thickness is 0.80-1.20 mm.

5. The method for manufacturing a series of osteotomy guides for condylar osteotomy as described in claim 1 or 4, characterized in that, In the step of drawing a condylar osteotomy guide plate with a second target thickness, based on the morphology of the mandible with the coracoid process removed and the position of the osteotomy line for condylar osteotomy, starting from the anterior edge of the ascending ramus and extending posteriorly to cover the coracoid process remnant, sigmoid notch, and anterior edge of the condylar neck; and in the step of drawing different parts of the condylar osteotomy guide plate with a second target width, with the anterior edge of the condylar osteotomy guide plate located at the anterior edge of the ascending ramus, the posterior edge covering the anterior edge of the condylar neck, and the upper edge aligned with the condylar osteotomy line, the second target width is 15-20 mm.

6. The method for manufacturing a series of osteotomy guides for condylar osteotomy as described in claim 1, characterized in that, In the step of 3D printing the coracoid osteotomy guide plate and the condylar osteotomy guide plate to obtain the osteotomy guide plate, the materials of the coracoid osteotomy guide plate and the condylar osteotomy guide plate are both resin or nylon.

7. The method for manufacturing the series of osteotomy guides for condylar osteotomy as described in claim 1, characterized in that, In the step of simulating the target surgical type on the virtual three-dimensional craniomaxillary model and determining the target position of the mandibular bone segment based on the terminal occlusal relationship, the target surgical type includes Le Fort type I osteotomy and mandibular sagittal splitting.

8. An osteotomy guide plate, characterized in that, The osteotomy guide plate is manufactured using the method described in any one of claims 1-7 for manufacturing a series of osteotomy guide plates for condylar osteotomy.

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