An individualized osteotomy and repositioning surgical guide system for mandibular body osteotomy and its manufacturing method and application

Abstract

The present invention discloses an individualized osteotomy and repositioning surgical guide system for mandibular body osteotomy, including an individualized osteotomy guide and a bone plate; the osteotomy guide can be fitted with the front of the mandible and used for osteotomy of the mandibular body, and the bone plate can be fitted with the mandibular body after osteotomy and used to locate and fix the bone end. The osteotomy guide is an integrated structure, including a first guide plate, a second guide plate, and a third guide plate covering the front of the mandible. The bone plate is a split structure, including a first bone plate and a second bone plate; the first bone plate and the second bone plate each include an integrated bone plate body, the bone plate body is rectangular as a whole, and a first extension portion and a second extension portion are also provided thereon. The present invention also discloses a preparation method of the above-mentioned surgical guide system and its application in mandibular deformity correction.

Description

Technical Field

[0001] The present invention belongs to the technical fields of digital guide plate design and medical devices, and relates to an individualized osteotomy and repositioning surgical guide plate system for mandibular body osteotomy and a manufacturing method thereof. Background Art

[0002] Body osteotomy is often used to correct severe mandibular prognathism and is one of the more difficult surgeries in the field of orthognathic surgery. Through body osteotomy, the mandible can be divided into three tooth-bone segments that can move independently of each other. If combined with bilateral sagittal split osteotomy, the mandible can be divided into five independent tooth-bone segments. Therefore, through this method, the tooth-bone segments can be adjusted to different positions according to the needs of preoperative surgical design, and can be used to correct severe dentofacial deformities. Since its surgical area is located in the anterior part of the mandible, adjacent to the inferior alveolar vascular nerve bundle, important anatomical structures such as tooth roots and the inferior alveolar vascular nerve bundle are often easily damaged during the operation due to improper osteotomy position. In addition, since body osteotomy often uses a stepped osteotomy, the osteotomy path is relatively complex, and improper bone removal during the operation often leads to the inability of the plate and the bone plate to be seated, affecting the occlusal relationship and the postoperative surgical effect; excessive bone removal results in a large bone gap, affecting postoperative bone healing. Therefore, accurate osteotomy during the operation is crucial for the implementation of the surgery and is also the difficulty of this surgery. Currently, for the intraoperative implementation of body osteotomy, it mainly relies on the personal experience of the surgeon. Improper osteotomy during the operation often leads to damage to important anatomical structures such as tooth roots and nerves, and even results in the inability of the subsequent bone plate to be seated, affecting the smooth progress of the surgery.

[0003] For intraoperative osteotomy of mandibular body osteotomy surgery, there is often no suitable surgical guide plate for current body osteotomy. It often relies solely on preoperative three-dimensional measurement and the intraoperative experience of the surgeon to perform osteotomy. This method has many deficiencies:

[0004] ① The key to this surgery lies in accurate intraoperative osteotomy. Too little bone removal during the operation often leads to early contact of the bone block, resulting in the inability of the plate to be seated, affecting the seating of the bone block, and ultimately affecting the occlusal relationship and surgical effect. Too much bone removal during the operation will result in a large bone gap, affecting postoperative bone healing.

[0005] ② Relying solely on the experience of the surgeon to perform osteotomy often inevitably damages important anatomical sites such as tooth roots and mental nerves, causing irreversible and serious consequences.

[0006] ③ Existing resin osteotomy guide plates, although they can also guide surgical osteotomy, are often made of non-rigid materials and may deform during preoperative manufacturing and disinfection processes, resulting in inaccurate fitting with the bone surface during the operation and affecting their use. In some cases, even guide plate fracture occurs before the operation, resulting in the inability to use during the operation.

[0007] For the intraoperative bone block fixation of mandibular body osteotomy, it mainly relies on plates (occlusal plates) to guide the positioning of each dental bone segment, and relies on commercially available four-hole titanium plates bent during the operation to fix the bone blocks, lacking an individualized titanium plate to fix the position of the bone segments. There are many deficiencies in this fixation method:

[0008] 1. Due to the large mobility of each bone block and the traction of the sublingual muscles, the control force of the plate on the positions of the bone blocks in all directions is insufficient, resulting in bone block displacement, unable to be accurately fixed to the position planned before the operation, thereby affecting the surgical precision, and ultimately affecting the postoperative occlusion relationship and surgical effect.

[0009] 2. The mechanical strength of traditional commercially available titanium plates is often low to facilitate bending according to the skeletal anatomical morphology during the operation. During the postoperative recovery process, due to the traction of the powerful sublingual muscles, the distal bone segment is prone to downward rotation, resulting in bone block displacement and ultimately causing recurrence of jaw deformity.

[0010] 3. Since commercially available titanium plates often need to be bent before fixation, even if the titanium plate is bent repeatedly, it still cannot fit perfectly with the bone block, and ultimately the fixation of the bone block cannot be implemented according to the surgical plan, ultimately affecting the surgical accuracy.

[0011] 4. In the fixation area of anterior osteotomy, there are often important anatomical structures such as tooth roots and inferior alveolar nerves. Fixing with only commercially available titanium plates relying on the experience of surgeons may damage important anatomical structures and cause serious postoperative complications.

[0012] Therefore, there is an urgent need to design an individualized osteotomy and repositioning surgical guide plate system for mandibular body osteotomy to assist in the implementation of the operation during the operation and fix the bone blocks after the operation. Summary of the Invention

[0013] To solve the deficiencies of the existing technology, the purpose of the present invention is to provide an individualized osteotomy and repositioning surgical guide plate system for mandibular body osteotomy, including an individualized osteotomy guide plate and an osteosynthesis plate, to guide the surgical operation results during the operation. During osteotomy, the osteotomy guide plate can prevent surgeons from operating solely based on experience during osteotomy, improve surgical precision while reducing surgical complications; while the osteosynthesis plate can accurately fit the bone surface according to the patient's anatomical morphology during the operation, guide the surgical operation to perform bone block reduction, and avoid damaging important anatomical structures during the operation. After the operation, the osteosynthesis plate has a certain strength to fix each bone block and prevent recurrence of postoperative bone block displacement. The surgical guide plate system in the present invention uses the method of metal printing to not only avoid deformation during production and disinfection, but also accurately fit the bone surface while reducing the size of the guide plate, achieving the effect of being both small and accurate.

[0014] The present invention provides an individualized osteotomy and repositioning surgical guide system for mandibular body osteotomy. The surgical guide system includes an individualized osteotomy guide plate and a bone plate. The osteotomy guide plate can fit with the anterior part of the mandible and is used for mandibular body osteotomy. The bone plate can fit with the anatomical shape of the mandibular body after osteotomy and is used to position the bone fracture ends and fix them.

[0015] The osteotomy guide plate is of an integral structure and includes a first guide plate, a second guide plate, and a third guide plate covering the anterior part of the mandible. The first guide plate and the second guide plate are connected by a first connecting part, and the first guide plate and the third guide plate are connected by a second connecting part.

[0016] According to the requirement of the osteotomy amount, when more bone needs to be removed, guiding plates can be added between the first guide plate and the second guide plate and / or between the first guide plate and the third guide plate. The guiding plates are connected to the first guide plate, the second guide plate and / or the first guide plate, the third guide plate through the first connecting part and / or the second connecting part.

[0017] Guiding osteotomy grooves are respectively formed between the first guide plate, the guiding plate, the second guide plate, and the third guide plate for guiding osteotomy during the operation.

[0018] The first guide plate mainly covers the front end of the mandible. The lower end of the first guide plate is arc-shaped, and the middle of the arc can correspond to the mental protuberance structure of the mandible, while the two sides of the arc surround the lower edge of the mandibular body. A plurality of first positioning holes are respectively arranged on both sides of the first guide plate. The first positioning holes are matched with the positioning pins used during the operation. The diameter of the first positioning holes is basically the same as that of the positioning pins, which can ensure that the osteotomy guide plate will not move after the positioning pins are inserted. The positioning pins can fix the first guide plate on the mandible by passing through the first positioning holes. The number and position of the first positioning holes can be determined according to the actual situation. Specifically, the distribution and orientation of the first positioning holes are set according to occlusion, morphology, and force direction to ensure that the osteotomy guide plate can be accurately fixed on the mandible, and at the same time, important anatomical structures in the mandible need to be avoided. The position of the first positioning holes corresponds to the position of the third positioning holes on the subsequent bone plate. The position where holes are drilled in the mandible through the first positioning holes is also the position corresponding to the third positioning holes on the subsequent bone plate.

[0019] A plurality of through holes can also be arranged on the first guide plate. There are no restrictions on the size and position of the through holes, and they can be set according to actual needs. The setting of the through holes can reduce the weight of the osteotomy guide plate and also reduce the manufacturing cost of the osteotomy guide plate to a certain extent.

[0020] Both sides of the first guide plate are in a broken line structure and are provided with protruding first guiding ridges to facilitate guiding the osteotomy path during the operation.

[0021] The position of the horizontal osteotomy line of the broken line structure on both sides of the first guide plate needs to be lower than the position where the root of tooth No. 3 (mandibular canine) is the longest.

[0022] The guide plate is in a broken line structure. By setting the guide plate, when the bone removal amount is large, the osteotomy path can be made more accurate, facilitating the osteotomy during the operation.

[0023] A number of second positioning holes are respectively provided on the second guide plate and the third guide plate. The second positioning holes are matched with the positioning pins used during the operation. The positioning pins can fix the second guide plate and / or the third guide plate to the mandible by passing through the second positioning holes; the number and position of the second positioning holes can be adjusted according to the actual situation. Specifically, the distribution and orientation of the second positioning holes are set according to occlusion, morphology and force direction to ensure that the osteotomy guide plate can be accurately fixed on the mandible, and at the same time, important anatomical structures within the mandible need to be avoided; the position of the second positioning holes corresponds to the position of the fourth positioning holes on the subsequent bone plate. The position where the holes are drilled in the mandible through the second positioning holes is also the position corresponding to the fourth positioning holes on the subsequent bone plate.

[0024] First arc-shaped recesses are respectively provided on the sides of the second guide plate and / or the third guide plate to avoid the mental foramen on the mandible.

[0025] The sides of the second guide plate and / or the third guide plate close to the first guide plate are in a broken line structure, and protruding second guiding ridges and third guiding ridges are respectively provided to facilitate guiding the osteotomy path during the operation.

[0026] When designing the osteotomy guide plate, the position of the tooth gap end of the osteotomy guide plate fully refers to the positions of the bilateral tooth roots, completely avoiding damaging the tooth roots during the operation.

[0027] The bone plate is a split structure, which is basically mirror-symmetrical left and right and is specifically adjusted according to the actual bone morphology. It includes a first bone plate and a second bone plate; both the first bone plate and the second bone plate respectively include an integrated bone plate main body. The bone plate main body is rectangular as a whole, and a first extension part and a second extension part are also provided thereon.

[0028] Third positioning holes and fourth positioning holes are respectively provided on the first bone plate and / or the second bone plate. The third positioning holes correspond to the positions of the first positioning holes in the osteotomy guide plate, and the fourth positioning holes correspond to the positions of the second positioning holes in the osteotomy guide plate, so that during the process of repositioning the bone segment, no secondary positioning is required, ensuring the accuracy of the docking of the bone fracture ends.

[0029] A rectangular hollowed-out area is provided in the middle of the bone plate body. The hollowed-out area can reduce the weight of the bone plate, reduce the stress shielding phenomenon generated by the bone plate, better conform to the principle of mandibular internal fixation, and can also reduce the manufacturing cost of the bone plate to a certain extent.

[0030] In the upper middle part of the bone plate body, a bone-connecting bending area corresponding to the mandibular osteotomy line is longitudinally provided. The shape of the bone-connecting bending area matches the shape at the osteotomy line, making the bone plate fit better with the mandible after osteotomy and docking.

[0031] Second arc-shaped concave edges are respectively provided on the sides of the first bone plate and / or the second bone plate to avoid the mental foramen on the mandible.

[0032] Letters L and R are respectively engraved on the first bone plate and the second bone plate, indicating that they are respectively used for the left and right sides of the patient. In the present invention, terms such as "first", "second", "third", etc. can be used to describe various elements, but these elements should not be limited by these terms. These terms are only used to distinguish one element from another.

[0033] The present invention also provides a method for manufacturing the above surgical guide plate system. The method combines digital surgical technology and conducts virtual surgical design before surgery, including determining the osteotomy line during surgery, the spatial position of the posterior bone block after movement, and the position of the nail holes expected to be used for bone plate fixation. The three-dimensional surgical plan before surgery is used to design the nail tracks for the individualized osteotomy guide plate for body osteotomy and the individualized bone plate. The individualized bone plate and osteotomy guide plate share the same set of nail tracks, and the virtual surgical plan is transferred to the surgical process through nail track transfer. Finally, the individualized osteotomy guide plate and individualized bone plate are manufactured by metal three-dimensional printing technology, thereby highly improving the accuracy of the surgery, reducing the difficulty of the surgery, and reducing the surgical complications.

[0034] The method includes the following steps:

[0035] Step 1: Collect information of the patient, including bite records, maxillofacial CT, two-dimensional and three-dimensional photos, etc.

[0036] Step 2: Import the maxillofacial CT into the surgical planning software, complete the osteotomy and movement of the upper and lower jaw bone blocks in the surgical planning software, and finally complete the surgical plan.

[0037] Step 3: Import the 3D digital model data of the bone block after surgical planning into the CAD software, and design an individualized titanium alloy surgical guide plate system for mandibular body osteotomy.

[0038] Step 4: Print and manufacture the designed surgical guide plate system by 3D printing technology.

[0039] The present invention also provides the application of the above surgical guide plate system and the manufacturing method of the surgical guide plate system in the correction of mandibular deformities.

[0040] The beneficial effects of the present invention include:

[0041] 1. Through the design and application of the individualized osteotomy and repositioning surgical guide plate system for mandibular body osteotomy of the present invention, it has changed the drawback of relying solely on the subjective experience of surgeons for osteotomy in the original surgical operation, and has high osteotomy accuracy. By using an individualized bone plate to guide and position the bone block, it has changed the way of simply relying on a plate to guide and position the bone block in the original surgical operation, effectively avoiding the displacement of the bone block in all directions during the fixation process, improving the surgical precision, highly matching the preoperative design, and achieving a good surgical effect.

[0042] 2. The device is small, light, and not easily deformed during repeated disinfection, highly conforms to the surface morphology of the mandible, and is convenient and simple to use.

[0043] 3. The individualized guide plate system is customized according to the patient's anatomical morphology, which is beneficial to the protection of important anatomical structures such as tooth roots and mental nerves, highly conforms to the patient's anatomical morphology, and avoids the bone block displacement caused by the inability of the prefabricated titanium plate to fit the bone block during intraoperative bending.

[0044] 4. The operation is simple and easy to promote.

[0045] 5. The individualized bone plate is made of titanium alloy and customized by three-dimensional printing technology, with high mechanical strength, preventing the recurrence of bone block displacement caused by the traction of the sublingual muscles after surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those skilled in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0047] Figure 1 is the overall front view of the osteotomy guide plate for mandibular body osteotomy of the present invention.

[0048] Figure 2 is the right side view of the osteotomy guide plate for mandibular body osteotomy of the present invention.

[0049] Figure 3 is the left side view of the osteotomy guide plate for mandibular body osteotomy of the present invention.

[0050] Figure 4It is the rear view of the osteotomy guide plate for the mandibular body osteotomy of the present invention.

[0051] Figure 5 It is the overall front view of the osteotomy guide plate for the mandibular body osteotomy of the present invention installed on the mandibular bone segment.

[0052] Figure 6 It is the right side view of the osteotomy guide plate for the mandibular body osteotomy of the present invention installed on the mandibular bone segment.

[0053] Figure 7 It is the left side view of the osteotomy guide plate for the mandibular body osteotomy of the present invention installed on the mandibular bone segment.

[0054] Figure 8 It is the front view of the first bone plate for mandibular body bone connection of the present invention.

[0055] Figure 9 It is a three-dimensional view of the first bone plate for mandibular body bone connection of the present invention in a certain direction.

[0056] Figure 10 It is a three-dimensional view of the first bone plate for mandibular body bone connection of the present invention in a certain direction.

[0057] Figure 11 It is a three-dimensional view of the second bone plate for mandibular body bone connection of the present invention in a certain direction.

[0058] Figure 12 It is a three-dimensional view of the second bone plate for mandibular body bone connection of the present invention in a certain direction.

[0059] Figure 13 It is a three-dimensional view of the second bone plate for mandibular body bone connection of the present invention in a certain direction.

[0060] Figure 14 It is the overall front view of the bone plate for mandibular body bone connection of the present invention installed on the mandibular bone segment.

[0061] Figure 15 It is the right side view of the bone plate for mandibular body bone connection of the present invention installed on the mandibular bone segment.

[0062] Figure 16 It is the left side view of the bone plate for mandibular body bone connection of the present invention installed on the mandibular bone segment.

[0063] In the figure, 1 is the first guide plate, 2 is the second guide plate, 3 is the third guide plate, 4 is the first connecting part, 5 is the second connecting part, 6 is the guiding plate, 7 is the first positioning hole, 8 is the through hole, 9 is the first guiding ridge, 10 is the horizontal osteotomy line, 11 is the second positioning hole, 12 is the first arc-shaped concave edge, 13 is the second guiding ridge, 14 is the third guiding ridge, 15 is the main body of the bone plate, 16 is the first extension part, 17 is the second extension part, 18 is the third positioning hole, 19 is the fourth positioning hole, 20 is the hollow area, 21 is the bone-connecting bending area, 22 is the second arc-shaped concave edge. Detailed implementation mode

[0064] Combined with the following specific embodiments and the attached drawings, the present invention will be further described in detail. The processes, conditions, experimental methods, etc. for implementing the present invention are all common knowledge and well-known common sense in the art except for the specifically mentioned content below, and the present invention has no particularly restricted content.

[0065] The present invention provides an individualized osteotomy and repositioning surgical guide plate system for the mandibular body osteotomy. Referring to Figures 1-16 , the surgical guide plate system includes an osteotomy guide plate and a bone plate; as Figures 1-7 shown, the osteotomy guide plate can be attached to the anterior part of the mandible and is used for osteotomy of the mandibular body; as Figures 8-16 shown, the bone plate can be attached to the mandibular body after osteotomy and is used to position the bone fracture ends and fix them.

[0066] As Figures 1-7 shown, the osteotomy guide plate is an integral structure, prefabricated according to the collected individualized information, can match the mandibular structure of the patient, and has accurate positioning. It includes the first guide plate 1, the second guide plate 2, and the third guide plate 3 covering the anterior part of the mandible; the first guide plate 1 and the second guide plate 2 are connected by the first connecting part 4, and the first guide plate 1 and the third guide plate 3 are connected by the second connecting part 5;

[0067] The shapes and structures of the first connecting part 4 and the second connecting part 5 match the bone surface at the corresponding positions of the mandible, and are used for close fitting during the operation to facilitate the operation during osteotomy.

[0068] According to the requirement of the osteotomy amount, when more bone needs to be removed, a guiding plate 6 can also be added between the first guide plate 1 and the second guide plate 2 and / or between the first guide plate 1 and the third guide plate 3. The guiding plate 6 is connected to the first guide plate 1, the second guide plate 2 and / or the first guide plate 1, the third guide plate 3 through the first connecting part 4 and / or the second connecting part 5.

[0069] Guiding osteotomy grooves are respectively formed between the first guide plate 1, the guiding plate 6, the second guide plate 2, and the third guide plate 3 for guiding osteotomy during the operation.

[0070] The first guide plate 1 mainly covers the front end of the mandible. The lower end of the first guide plate 1 is arc-shaped, and the middle of the arc can correspond to the mental protuberance structure of the mandible, while the two sides of the arc wrap around the lower edge of the body of the mandible. A number of first positioning holes 7 are respectively arranged on both sides of the first guide plate 1, and the first positioning holes 7 are matched with the positioning pins used during the operation. The positioning pins can fix the first guide plate 1 to the mandible by passing through the first positioning holes 7. The number and positions of the first positioning holes 7 can be adjusted according to the actual situation. Specifically, the distribution and orientation of the first positioning holes 7 are set according to occlusion, morphology and force direction, and the positions where the positioning pins are inserted need to avoid important anatomical structures within the mandible.

[0071] A number of through holes 8 can also be arranged on the first guide plate. There are no restrictions on the size and position of the through holes 8, and they can be set according to actual needs. The setting of the through holes 8 can reduce the weight of the osteotomy guide plate and also reduce the manufacturing cost of the osteotomy guide plate to a certain extent.

[0072] Both sides of the first guide plate 1 are in a broken line structure, and a protruding first guiding ridge 9 is arranged, which is convenient for guiding the osteotomy path during the operation and making the osteotomy plane flat, ensuring the postoperative aesthetic effect.

[0073] The position of the horizontal osteotomy line 10 of the broken line structure on both sides of the first guide plate 1 needs to be lower than the position where the root of the No. 3 tooth is the longest.

[0074] The guiding plate 6 is in a broken line structure. By setting the guiding plate 6, the osteotomy path is made more accurate, which is convenient for performing osteotomy during the operation.

[0075] A number of second positioning holes 11 are respectively arranged on the second guide plate 2 and the third guide plate 3. The second positioning holes 11 are matched with the positioning pins used during the operation. The positioning pins can fix the second guide plate 2 and / or the third guide plate 3 to the mandible by passing through the second positioning holes 11. The number and positions of the second positioning holes 11 can be adjusted according to the actual situation. Specifically, the distribution and orientation of the second positioning holes 11 are set according to occlusion, morphology and force direction, and the positions where the positioning pins are inserted need to avoid important anatomical structures within the mandible.

[0076] First arc-shaped concave edges 12 are respectively arranged on the sides of the second guide plate 2 and / or the third guide plate 3 to avoid the mental foramen on the mandible.

[0077] The sides of the second guide plate 2 and / or the third guide plate 3 close to the first guide plate 1 are in a broken line structure, and a protruding second guiding ridge 13 and a third guiding ridge 14 are respectively arranged, which is convenient for guiding the osteotomy path during the operation and making the osteotomy plane flat, ensuring the postoperative aesthetic effect.

[0078] When designing the osteotomy guide plate, the interdental end of the osteotomy guide plate fully refers to the positions of the bilateral tooth roots, completely avoiding the situation that the osteotomy position is too close to the tooth roots or directly contacts the tooth roots during the operation, thus damaging the tooth roots.

[0079] When the osteotomy guide plate fits with the corresponding part on the outer side of the patient's mandible, the first positioning holes 7 and the second positioning holes 11 also fit to the accurate positions preset on the mandible and are fixed by positioning nails, ensuring the accuracy of the position during the osteotomy process.

[0080] The bone plate is of a split structure, basically mirror-symmetrical left and right, and includes a first bone plate and a second bone plate; both the first bone plate and the second bone plate respectively include an integrated bone plate main body 15, and the bone plate main body 15 is rectangular as a whole, and is also provided with a first extension part 16 and a second extension part 17 thereon.

[0081] Both the first bone plate and / or the second bone plate are provided with a third positioning hole 18 and a fourth positioning hole 19. The third positioning hole 18 corresponds to the position of the first positioning hole 7 in the osteotomy guide plate, and the fourth positioning hole 19 corresponds to the position of the second positioning hole 11 in the osteotomy guide plate, so that during the process of repositioning the bone segment, secondary positioning is not required, ensuring the accuracy of the docking of the bone fracture ends.

[0082] A rectangular hollow area 20 is arranged in the middle of the bone plate main body. The hollow area 20 can reduce the weight of the bone plate, reduce the stress shielding phenomenon generated by the bone plate, be more in line with the principle of internal fixation of the mandible, and can also reduce the manufacturing cost of the bone plate to a certain extent.

[0083] A bone plate bending area 21 corresponding to the mandibular osteotomy line is longitudinally arranged in the upper middle part of the bone plate main body. The shape of the bone plate bending area 21 matches the shape at the osteotomy line, making the bone plate fit more closely with the mandible after osteotomy and docking and splicing.

[0084] Second arc-shaped concave edges 22 are respectively arranged on the sides of the first bone plate and / or the second bone plate for avoiding the mental foramen on the mandible.

[0085] The bone plate in the present invention is individually manufactured according to the anatomical shape of the patient after the operation, ensuring the accuracy of the surgical movement. At the same time, the fixation with multiple rows of upper and lower nail holes conforms to the principle of internal fixation of mandibular fractures. The design of the nail holes fully considers important anatomical structures such as tooth roots and inferior alveolar nerves in the mandible, avoiding damaging important anatomical structures during the operation and causing serious postoperative complications; at the same time, they are used in pairs on the left and right, and English letters are engraved on the bone plate during the design for easy distinction during the operation.

[0086] The bone plate in the present invention ensures the accuracy of surgical movement by completely conforming to the anatomical shape of the patient. At the same time, the foraminal structures on both sides of the mandible near the midline are mental foramens, through which the mental nerve passes. The mental nerve is an important nerve that innervates the sensation of the lower lip. During the preoperative surgical design, the position and course of the mental nerve are determined, and in the preoperative design of the individualized bone plate, attention is paid to avoiding this structure to prevent serious postoperative complications caused by damage to this structure during the operation.

[0087] The manufacturing and usage steps of the surgical guide plate system in the present invention are as follows: ① After the patient enters the digital orthognathic surgery process, relevant clinical data are collected, including occlusal records, maxillofacial CT, two-dimensional and three-dimensional photos. Among them, the maxillofacial CT is taken using a computed tomography (CT) device (Brilliance 64-slice spiral CT, Philips, Netherlands) for the maxillofacial region (requiring a slice thickness of 0.625 mm, and the scanning range is from the skull vertex to the hyoid bone in plain scan, with the occlusal intercuspal position or slightly open mouth). After the shooting is completed, the electronic data file is obtained through the medical imaging storage system GE Medical System (GE Healthcare, USA) and exported in DICOM format; ② After saving the maxillofacial CT in DICOM format, it is imported into the surgical planning software (Proplan CMF 2.0, Materialise company, Belgium) to reconstruct the three-dimensional model and perform simulated surgical osteotomy. Before the operation, based on the patient's main complaint, clinical examination, and three-dimensional measurement analysis, the surgeon uses the surgical planning software to complete the osteotomy and movement of the upper and lower jaw bone blocks, and determines and finally completes the formulation of the surgical plan through multiple repeated simulation effects; ③ After the surgeon and the designer have a complete and detailed communication about the overall surgical plan, the necessary data for manufacturing the guide plate are exported, and the designer starts to manufacture the guide plate. ④ According to the osteotomy and the final placement position of the bone block in the surgeon's simulated surgical plan, the designer uses the forward modeling computer-aided design software (Geomagic Spark 2013 (Geomagic company, USA)) and the reverse modeling computer-aided design software (Geomagic Studio 2013 (Geomagic company, USA)) to design an individualized metal surgical guide plate system that fits the anatomical shape of the patient's mandibular bone surface and is 0.85 mm thick with a distance of 0.05 mm from the patient's bone surface, including an osteotomy guide plate and an osteosynthesis plate. A 1-mm-wide guiding groove is made on the bone support surface according to the originally designed osteotomy line. In order to accurately perform osteotomy and reduce errors, important anatomical structures such as the inferior alveolar nerve and tooth roots need to be avoided simultaneously when designing the osteotomy line. ⑤ Since the individualized osteosynthesis plate and the osteotomy guide plate share a set of nail holes, the nail hole position of the osteotomy guide plate can be obtained in reverse through the nail hole data of the individualized osteosynthesis plate. A positioning nail hole with a diameter of 2.2 mm is designed on the osteotomy guide plate through the position of the retention nail hole for fixing the osteotomy guide plate during the operation. The osteotomy guide plate manufactured by this method fits perfectly with the anatomical shape of the mandible.Meanwhile, the design of the bone plate strictly follows the principles of mandibular internal fixation and fits perfectly with the postoperative bone mass, achieving precise reduction and fixation of the mandibular bone mass. At the same time, through digital technology, important anatomical structures such as tooth roots and inferior alveolar nerves can be reconstructed and visualized. When designing the nail holes and osteotomy lines of the osteotomy guide plate, damage to these important anatomical structures can be avoided; the positions of the nail holes for fixing the individualized bone plate are the same as those for fixing the osteotomy guide plate, with a diameter of 2.2 mm. Through this method of nail hole transfer, the virtual surgical plan can be accurately transferred to the surgical process, and damage to important anatomical structures such as tooth roots and inferior alveolar nerves during the surgery can be avoided. ⑥ After the design is completed, the surgeon reviews the design of the osteotomy guide plate and the individualized bone plate before surgery, including the shape, size, the range of the bone surface covered, and whether important anatomical structures are damaged, etc.; ⑦ After passing the review, the data of the osteotomy guide plate and the individualized bone plate are exported in the form of STL format files, and Ti6Al4V alloy is used as the raw material, and selective laser melting technology (ConceptLaser, Germany) is used for three-dimensional printing production. ⑧ One day before the surgery, the surgeon tries on the individualized titanium alloy osteotomy guide plate in advance through the mandibular model to avoid affecting its use during the surgery due to deformation of the guide plate. After the trial fitting is completed, the osteotomy guide plate is sterilized at high temperature and high pressure for use during the surgery. The individualized osteotomy guide plate produced is as Figures 1-4 shown, and the individualized bone plate produced is as Figures 8-13 shown.

[0088] During the surgery, the osteotomy guide plate can fit perfectly with the bone surface morphology, and the osteotomy guide plate can be accurately positioned on the mandible through the nail holes on the surface of the osteotomy guide plate to avoid its displacement. The bone mass between the osteotomy grooves in the osteotomy guide plate is the bone segment that needs to be removed during the surgery. The zigzag osteotomy design of the guide plate not only perfectly avoids the mental nerve, avoiding the risk of lower lip numbness caused by damage to the mental nerve during the surgery, but also the horizontal osteotomy line is individually designed according to the length of the tooth root, avoiding damage to the tooth root during the surgery. In addition, the zigzag osteotomy design ensures a large range of bone contact between the osteotomy segments, which is beneficial to postoperative bone repair and avoids the occurrence of nonunion. The schematic diagram of the individualized osteotomy guide plate for mandibular body osteotomy placed on the mandibular bone segment is shown in Figures 5-7.

[0089] Figure 6Among them, ① the interdental end of the osteotomy guide plate fully refers to the positions of the bilateral tooth roots, completely avoiding damage to the tooth roots during the operation. ② The position of the longest mandibular canine tooth among the tooth roots is also fully referred to at the horizontal osteotomy line, and it is avoided to prevent the tooth root from being transected during the operation. ③ The foraminal structures on both sides of the midline of the mandible are mental foramens, in which the mental nerve runs, and it is an important nerve that dominates the sensation of the lower lip. The position and course of the mental nerve are judged in the preoperative surgical design stage, and attention is paid to avoiding this structure during the osteotomy design and the design and production of the osteotomy guide plate to prevent serious postoperative complications caused by damage to this structure during the operation. ④ By increasing the contact area with the surface of the mandible, the osteotomy guide plate facilitates the precise positioning of the guide plate on the surface of the mandible. Its lower edge surrounds the lower edge of the mandible, increasing the uniqueness and stability of the positioning and ensuring the precision and uniqueness of the osteotomy.

[0090] During the process of surgical osteotomy, the bone segment to be removed is located between the left and right osteotomy slots of the osteotomy guide plate. During the operation, an ultrasonic bone scalpel or a saw blade can be used to perform precise osteotomy along the osteotomy slots of the guide plate. The specific steps during the operation are as follows: ① During the operation, expose the mandible through the mandibular vestibular sulcus according to the traditional surgical method, and place the mandibular osteotomy guide plate on the bone surface of the mandible. Due to the complex and relatively unique arcuate surface morphology of the mandible, when the osteotomy guide plate is completely fitted to the bone surface, the osteotomy guide plate is accurately positioned and reaches the unique position predicted before the operation; ② The nail holes in the osteotomy guide plate can guide the surgeon to prepare nail holes on the surface of the mandible and use screws to fix the osteotomy guide plate; ③ The bone segment to be removed is located between the left and right osteotomy slots of the osteotomy guide plate. Under the guidance of the osteotomy slots in the osteotomy guide plate, the surgeon performs osteotomy and bone removal according to the surgical plan; ④ After removing the osteotomy guide plate, continue to complete osteotomy and bone removal; ⑤ The mandibular nail holes used to fix the osteotomy guide plate can be used as bony landmark points and directly used for the subsequent individualized bone plate.

[0091] During the process of repositioning the osteotomy bone block, in combination with the use of an individualized bone plate, the nail holes used to fix the osteotomy guide plate are used as bony landmark points, and the precise refixation of the mandibular bone block is completed through the method of nail hole transfer. The specific steps during the operation are as follows: ① After the osteotomy of the mandibular body is completed, rotate and move the anterior bone block of the mandible to match the positions of the nail holes prepared on the bone block with the nail holes on the individualized bone plate. ② When the nail holes on the outside of the individualized bone plate for the osteotomy of the mandibular body are aligned with the corresponding nail holes prepared, use screws to fix the anterior and posterior bone segments of the mandible. ③ When using screws to fix the nail holes of the anterior bone block of the mandible to the individualized bone plate, the anterior bone block is accurately guided to the position designed before the operation. ④ Similarly, fix the other side of the osteotomy of the mandibular body. Through this method, the intraoperative positioning and fixation of the bone block are achieved, and there is no need to use an intermediate Plates and intermaxillary fixation. Through the precise reduction and fixation of bone fragments, better surgical outcomes can be achieved. In addition, the individualized bone plates designed and fabricated according to the patient's anatomical morphology are beneficial for the protection of important anatomical structures such as tooth roots and mental nerves. At the same time, the individualized bone plates fabricated by three-dimensional printing have relatively high strength, which can effectively avoid the displacement and recurrence of bone fragments after surgery and improve the postoperative stability of the operation.

[0092] Through this method, precise osteotomy surgical operations during the surgery can be realized, which not only improves the surgical accuracy and achieves better surgical outcomes, but also is beneficial for the protection of important anatomical structures such as tooth roots and mental nerves, reducing the surgical complications. At the same time, the manufacturing method of metal three-dimensional printing can not only avoid the deformation of non-rigid materials during the manufacturing and disinfection processes, but also accurately fit the bone surface while reducing the size of the guide plate, achieving the effect of being both compact and accurate.

[0093] The protection scope of the present invention is not limited to the above embodiments. Without departing from the spirit and scope of the inventive concept, the changes and advantages that can be conceived by those skilled in the art are included in the present invention, and the appended claims are used as the protection scope.

Claims

1. A personalized osteotomy and repositioning surgical guide system for mandibular body osteotomy, characterized in that: It includes an individualized osteotomy guide plate and a bone plate; the osteotomy guide plate can be fitted with the front part of the mandible for osteotomy of the mandible body, and the bone plate can be fitted with the mandible body after osteotomy for locating the position of the bone end and fixing it; The osteotomy guide plate is an integrated structure, comprising a first guide plate (1), a second guide plate (2), and a third guide plate (3) covering the front part of the mandible; the first guide plate (1) and the second guide plate (2) are connected via a first connecting portion (4), and the first guide plate (1) and the third guide plate (3) are connected via a second connecting portion (5); A guide plate (6) is further provided between the first guide plate (1) and the second guide plate (2) and / or between the first guide plate (1) and the third guide plate (3); the guide plate (6) is connected to the first guide plate (1) and the second guide plate (2) via a first connecting portion (4), and / or the guide plate (6) is connected to the first guide plate (1) and the third guide plate (3) via a second connecting portion (5); A guiding osteotomy groove is formed between the guide plate (6) and the second guide plate (2), the first guide plate (1), and between the first guide plate (1) and the third guide plate (3); and / or a guiding osteotomy groove is formed between the guide plate (6) and the third guide plate (3); Both sides of the first guide plate (1) are folded line structures and are provided with protruding first guide ridges (9); The positions of the horizontal osteotomy lines (10) of the broken line structures on both sides of the first guide plate (1) are lower than the longest position of the root of tooth No. 3; The guide plate (6) is a broken line structure. By providing the guide plate (6), the osteotomy path is made more accurate, and the osteotomy during the operation is facilitated. The side edges of the second guide plate (2) and / or the third guide plate (3) close to the first guide plate (1) are of a fold line structure and are respectively provided with a protruding second guide ridge (13) and a third guide ridge (14).

2. The surgical guide system according to claim 1, wherein: The first guide plate (1) is wrapped around the front end of the mandible, the lower end of the first guide plate (1) is arc-shaped, the middle part of the arc corresponds to the chin bulge structure of the mandible, and the two sides of the arc surround the lower edge of the body of the mandible; a plurality of first positioning holes (7) are respectively arranged on both sides of the first guide plate (1), and the first positioning holes (7) match the positioning pins used in the operation; the positioning pins fix the first guide plate (1) on the mandible by passing through the first positioning holes (7).

3. The surgical guide system according to claim 1, wherein: The second guide plate (2) and the third guide plate (3) are respectively provided with a plurality of second positioning holes (11), and the second positioning holes (11) match the positioning pins used in the operation, and the positioning pins can fix the second guide plate (2) and / or the third guide plate (3) on the mandible by passing through the second positioning holes (11).

4. The surgical guide system according to claim 1, wherein: The side edges of the second guide plate (2) and / or the third guide plate (3) are also respectively provided with a first arc-shaped concave edge (12) for avoiding the mandibular nerve foramen on the mandible.

5. The surgical guide system according to claim 1, wherein: The bone fracture plate is a split structure, comprising a first bone fracture plate and a second bone fracture plate; the first bone fracture plate and the second bone fracture plate each comprise an integrated bone fracture plate body (15), the bone fracture plate body (15) being rectangular as a whole and being provided with a first extension portion (16) and a second extension portion (17).

6. The surgical guide system according to claim 5, characterized in that: The first bone plate and the second bone plate are both provided with a third positioning hole (18) and a fourth positioning hole (19), wherein the third positioning hole (18) corresponds to the position of the first positioning hole (7) in the osteotomy guide plate, and the fourth positioning hole (19) corresponds to the position of the second positioning hole (11) in the osteotomy guide plate.

7. The surgical guide system according to claim 5, characterized in that: A rectangular hollow area (20) is provided in the middle of the bone fracture plate body (15); A bone-setting bending zone (21) corresponding to the mandibular osteotomy line is longitudinally arranged in the middle of the main body of the bone-setting plate, and the shape of the bone-setting bending zone (21) matches the shape of the osteotomy line; The side edges of the first bone fracture plate and / or the second bone fracture plate are also respectively provided with second arc-shaped concave edges (22) for avoiding the mandibular nerve foramen on the mandible.

8. A method for manufacturing a surgical guide system according to any one of claims 1 to 7, characterized in that: The method comprises the following steps: Step 1: Collect the patient's information including bite records, maxillofacial CT, 2D photos and 3D photos; Step 2: Import the maxillofacial CT into the surgical planning software, complete the osteotomy and movement of the upper and lower jaw bone blocks in the surgical planning software, and finally complete the surgical plan; Step 3: Import the 3D digital model data of the bone block after surgical planning into the CAD software to design an individualized titanium alloy surgical guide system for mandibular body osteotomy; Step 4: Print the designed surgical guide system using 3D printing technology.

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