A method for manufacturing a jaw fixation and morphological filling body

Abstract

The invention discloses a method for manufacturing a jaw bone fixation and morphological filling body, which belongs to the field of surgical operation technology, and includes the following steps: preliminary design of the filling body: designing a PEEK material filling body A according to the patient's bone morphological imaging data; positioning guide plate design: designing a bone cutting line and a positioning hole on the positioning guide plate; secondary design of the filling body: simulating bone cutting surgery to obtain the postoperative new bone morphology, and subtracting the overlapping part of the PEEK material filling body A with the free bone block to obtain the PEEK material filling body B; tertiary design of the filling body: designing a retention hole on the PEEK material filling body B, and performing edge trimming and surface smoothing treatment to obtain the PEEK material filling body C; manufacturing the filling body and positioning guide plate: manufacturing according to the design scheme of the PEEK material filling body C and the positioning guide plate. A filling body made of PEEK material can be manufactured, which can achieve the dual functions of postoperative bone block fixation and bone morphological filling, simplify the surgical process, and has no imaging artifacts.

Description

Technical Field

[0001] The present invention relates to the technical field of surgical operations, and in particular to a method for manufacturing a jaw fixation and form filling body. Background Art

[0002] Oral and craniomaxillofacial bone incision and relocation surgery (such as maxillary bone incision surgery) is a common surgical method for treating oral, dental, maxillofacial and craniomaxillofacial deformities. After bone incision and relocation surgery, the bone blocks are usually fixed with titanium plates and titanium nails. However, titanium metal materials have biocompatibility issues, which may cause adverse reactions such as metal allergies and imaging artifacts. In addition, after bone incision and relocation surgery, patients may still have poor bone morphology in the fixed areas (such as the nasal base and paranasal areas, orbital areas, and maxillary anterior wall areas), poor facial fullness, and affect facial beauty. Therefore, additional filling surgery is required, which increases the patient's operation time, complexity, and risk. Summary of the invention

[0003] The purpose of the present invention is to solve the above-mentioned technical problems and provide a method for producing a mandibular fixation and morphological filling body, which can produce a mandibular fixation and morphological filling body made of PEEK material, which has excellent mechanical properties, biocompatibility and an elastic modulus close to that of human bones, and can achieve the dual functions of postoperative bone block fixation and bone morphological filling after bone incision and movement surgery, thereby simplifying the surgical process, improving the postoperative aesthetic effect, and having no imaging artifacts, facilitating postoperative evaluation, and having broad clinical application prospects.

[0004] To achieve the above object, the present invention provides the following solution: The present invention discloses a method for manufacturing a jaw fixation and morphological filling body, comprising the following steps:

[0005] Preliminary design of jaw fixation and morphological filling body: Collect bone morphological imaging data of the patient's surgical area, and design PEEK material filling body A based on the bone morphological imaging data;

[0006] Positioning guide design: The positioning guide is designed according to the bone morphology imaging data, and the bone cutting line and positioning holes are designed on the positioning guide. The bone cutting line is used to guide the bone saw to cut the surgical area, and the positioning hole is used to fix the positioning guide on the bone surface of the surgical area and leave a marking hole;

[0007] Secondary design of jaw fixation and morphological filling body: According to the bone incision and movement surgery plan, the bone incision surgery is simulated to obtain the new bone morphology of the surgical area after the surgery, and the PEEK material filling body A is subtracted from the overlapping part of the free bone block with the new bone morphology to obtain the design plan of the PEEK material filling body B;

[0008] Three-time design of jaw fixation and morphological filling body: Retention holes are designed on PEEK filling body B, and the retention holes correspond one to one with the marked holes on the bone surface after the simulated bone incision and movement surgery. The design of PEEK filling body B is trimmed at the edge and smoothed on the surface to obtain the design of PEEK filling body C.

[0009] Production of the mandibular fixation and morphological filling body and the positioning guide: Production is carried out according to the design plan of the PEEK material filling body C and the design plan of the positioning guide.

[0010] Preferably, the three-dimensional image data of the bone morphology is acquired by CT scanning the surgical area of ​​the patient.

[0011] Preferably, the three-dimensional impact data is imported into computer modeling software, and the positioning guide and the jaw fixation and form filling body are designed using the computer modeling software.

[0012] Preferably, the computer modeling software is used in combination with FreeForm Modeling Plus software and CAD software.

[0013] Preferably, the overlapping portion between the PEEK material filling body A and the free bone block is subtracted using Boolean operation.

[0014] Preferably, the positioning guide plate and the PEEK material filling body C are manufactured by 3D printing according to the model data output by the computer modeling software.

[0015] Preferably, after the positioning guide plate and the PEEK material filling body C are manufactured, the positioning guide plate and the PEEK material filling body C are disinfected and sterilized.

[0016] Preferably, the disinfected and sterilized positioning guide plate and the PEEK material filling body C are packaged.

[0017] Preferably, the surgical area is the maxillary bone or the mandibular bone.

[0018] Compared with the prior art, the present invention has achieved the following technical effects:

[0019] The method for producing a mandibular fixation and morphological filling body of the present invention can produce a mandibular fixation and morphological filling body made of PEEK material. The Chinese name of PEEK material is polyetheretherketone, which has excellent mechanical properties and biocompatibility. Therefore, it will not cause adverse reactions such as metal allergies and inflammation when used as a fixation plate. At the same time, PEEK material has an elastic modulus close to that of human bones, and is an excellent filler material. It can then have both the functions of a fixation plate and a filler, and can complete the functions of bone fixation and bone morphological filling in the same operation without the need for an additional operation, thereby reducing the operation time, complexity and risk, filling bone morphology maldevelopment, improving facial fullness, and enhancing the patient's postoperative facial contour beauty. The characteristic of the elastic modulus close to that of human bones can also reduce stress shielding, and will not produce metal artifacts in imaging examinations, which is convenient for postoperative evaluation and has important clinical significance. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0021] Figure 1 A simulated diagram of the positional relationship between the maxillary bone and the PEEK material filling body A in the embodiment;

[0022] Figure 2 It is a simulated front view of the morphological structure of the maxillary PEEK material filling body A in the embodiment;

[0023] Figure 3 It is a simulated side view of the morphological structure of the maxillary PEEK material filling body A in the embodiment;

[0024] Figure 4 It is a simulated rear view of the morphological structure of the maxillary PEEK material filling body A in the embodiment;

[0025] Figure 5 A simulated diagram of the positional relationship between the maxillary bone and the positioning guide plate in the embodiment;

[0026] Figure 6 A simulated front view of the morphological structure of the positioning guide plate in the embodiment;

[0027] Figure 7 A simulated side view of the morphological structure of the positioning guide plate in the embodiment;

[0028] Figure 8 A simulated rear view of the morphological structure of the positioning guide plate in the embodiment;

[0029] Fig. 9 This is a simulated diagram of the positional relationship between the maxillary bone and the PEEK material filling body B in the embodiment;

[0030] Fig.10 It is a simulated front view of the morphological structure of the maxillary PEEK material filling body B in the embodiment;

[0031] Fig.11 It is a simulated side view of the morphological structure of the maxillary PEEK material filling body B in the embodiment;

[0032] Fig.12 It is a simulated rear view of the morphological structure of the maxillary PEEK material filling body B in the embodiment;

[0033] Fig.13 It is a simulated diagram of the positional relationship between the maxillary bone and the PEEK material filling body C in the embodiment;

[0034] Fig.14 It is a simulated front view of the morphological structure of the maxillary PEEK material filling body C in the embodiment;

[0035] Fig.15 It is a simulated side view of the morphological structure of the maxillary PEEK material filling body C in the embodiment;

[0036] Fig.16 It is a simulated rear view of the morphological structure of the maxillary PEEK material filling body C in the embodiment;

[0037] Fig.17 It is a left-side simulation diagram of the maxillary bone and the PEEK material filling body C after fixation in the embodiment;

[0038] Fig.18 This is a front view simulation diagram of the maxillary bone and the PEEK material filling body C after fixation in the embodiment;

[0039] Fig.19 It is a right-view simulation diagram of the maxillary bone and the PEEK material filling body C after fixation in the embodiment;

[0040] Fig. 20 This is a rear view simulation diagram of the maxillary bone and the PEEK material filling body C after fixation in the embodiment;

[0041] Fig.21 It is a simulated diagram of the positional relationship between the chin bone part and the PEEK material filling body C in the embodiment;

[0042] Fig. 22 It is a simulated front view of the morphological structure of the chin PEEK material filling body C in the embodiment;

[0043] Fig.23It is a simulated side view of the morphological structure of the chin PEEK material filling body C in the embodiment;

[0044] Fig.24 It is a simulated rear view of the morphological structure of the PEEK material filling body C in the chin part in the embodiment.

[0045] Explanation of the accompanying drawings: 1. Positioning guide plate; 2. PEEK material filling body A; 3. PEEK material filling body B; 4. PEEK material filling body C; 5. Bone cutting line; 6. Positioning hole; 7. Retention hole; 8. Screw; 9. Maxilla; 10. Mental bone. DETAILED DESCRIPTION

[0046] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0047] This embodiment provides a method for manufacturing a jaw fixation and morphological filling body, such as Figures 1 to 24 As shown, the following steps are included:

[0048] Preliminary design of jaw fixation and morphological filling body: collect bone morphological imaging data of the patient's surgical area (such as maxillary bone 9 or chin bone 10, etc.), and design PEEK material filling body A2 according to the bone morphological imaging data;

[0049] Positioning guide design: The positioning guide 1 is designed according to the bone morphology imaging data, and a bone cutting line 5 and a positioning hole 6 are designed on the positioning guide 1. The bone cutting line 5 is used to guide the bone saw to cut the surgical area, and the positioning hole 6 is used to fix the positioning guide 1 on the bone surface of the surgical area and leave a marking hole;

[0050] Secondary design of jaw fixation and morphological filling body: According to the osteotomy and movement surgery plan, the osteotomy surgery was simulated to obtain the new bone morphology of the surgical area after the surgery. The overlapping part of the free bone block with the new bone morphology was subtracted from the PEEK material filling body A2 to obtain the design plan of the PEEK material filling body B3;

[0051] Three-time design of jaw fixation and morphological filling body: design retention holes 7 on PEEK material filling body B3, which correspond one-to-one with the marked holes on the bone surface after the simulated bone incision and movement surgery, and perform edge trimming and surface smoothing on the design of PEEK material filling body B3 to obtain the design of PEEK material filling body C4;

[0052] Production of the mandibular fixation and morphological filling body and positioning guide: Production is carried out according to the design plan of the PEEK material filling body C4 and the design plan of the positioning guide 1.

[0053] Beneficial effects:

[0054] The method for producing a mandibular fixation and morphological filling body can produce a mandibular fixation and morphological filling body made of PEEK material. The Chinese name of PEEK material is polyetheretherketone, which has excellent mechanical properties and biocompatibility. Therefore, it will not cause adverse reactions such as metal allergies and inflammation when used as a fixation plate. At the same time, PEEK material has an elastic modulus close to that of human bones, and is an excellent filling body material. It can then have both the functions of a fixation plate and a filling body, and can complete the functions of bone fixation and bone morphological filling in the same operation without the need for an additional operation, thereby reducing the operation time, complexity and risk, filling bone morphology maldevelopment, improving facial fullness, and enhancing the patient's postoperative facial contour beauty. In addition, the elastic modulus close to that of human bones can also reduce stress shielding, and will not produce metal artifacts in imaging examinations, which is convenient for postoperative evaluation and has important clinical significance.

[0055] The treatment process is as follows:

[0056] (1) Preoperative preparation:

[0057] The surgeon prepares the sterilized positioning guide plate 1 and the PEEK material filling body C4 according to the surgical plan.

[0058] (2) Surgery Implementation:

[0059] Place the positioning guide 1 at a preset position in the surgical area, leave a marking hole on the bone surface through the positioning hole 6, and use a bone saw to cut the surgical area along the bone cutting line 5 so that the free bone blocks in the surgical area after cutting can be easily moved to the predetermined position.

[0060] (3) Use of PEEK material C:

[0061] The retention holes 7 on the PEEK material filling body C4 are aligned with the marking holes left on the bone surface, and then fixed with screws 8, thereby achieving bone block fixation and bone morphology filling at the same time.

[0062] (4) Postoperative care: Check the stability of the fixed bone blocks and the effect of bone morphology filling, and perform routine postoperative care and follow-up.

[0063] In one embodiment, if Figures 1 to 24 As shown, three-dimensional imaging data of bone morphology is obtained by CT scanning the patient's surgical area.

[0064] In one embodiment, if Figures 1 to 24As shown, the three-dimensional impact data is imported into the computer modeling software, and the computer modeling software is used to design the positioning guide plate 1 and the jaw fixation and morphological filling body.

[0065] In one embodiment, if Figures 1 to 24 As shown, the computer modeling software is FreeForm ModelingPlus software and CAD software used in combination.

[0066] In one embodiment, if Figures 1 to 24 As shown, the overlapping portion between the PEEK material filling body A2 and the free bone block is subtracted using Boolean operation.

[0067] In one embodiment, if Figures 1 to 24 As shown, according to the model data output by the computer modeling software, the positioning guide plate 1 and the PEEK material filling body C4 are manufactured by 3D printing.

[0068] In one embodiment, if Figures 1 to 24 As shown, after the positioning guide plate 1 and the PEEK material filling body C4 are manufactured, the positioning guide plate 1 and the PEEK material filling body C4 are disinfected and sterilized.

[0069] In one embodiment, if Figures 1 to 24 As shown, the disinfected and sterilized positioning guide plate 1 and the PEEK material filling body C4 are packaged.

[0070] In one embodiment, if Figures 1 to 24 As shown, the surgical area is the maxilla 9, and the bone incision and movement surgery is the maxillary bone incision and movement surgery:

[0071] First, the three-dimensional CT image data of the bone morphology of the patient's maxillary bone 9 is collected, and the three-dimensional CT image data is imported into FreeForm Modeling Plus software and CAD software for modeling. The PEEK material filling body A2 is designed according to the modeling design (such as Figures 1 to 4 shown);

[0072] Then, the positioning guide plate 1 is designed according to the modeling, and the bone cutting line 5 and the positioning hole 6 are designed on the positioning guide plate 1. The bone cutting line 5 is used to guide the bone saw to cut the maxillary bone 9, and the positioning hole 6 is used to fix the positioning guide plate 1 on the bone surface of the maxillary bone 9 and leave a marking hole (such as Figures 5 to 8 shown);

[0073] Then, according to the maxillary bone incision and movement surgery plan, the maxillary bone incision and movement surgery was simulated (the maxillary Le Fort I bone incision and advancement surgery was used as an example to advance the maxillary free bone block, and the movement amount of the maxillary free bone block was obtained. Then, the PEEK material filling body A2 was subtracted from the overlapped part with the maxillary free bone block by Boolean operation to obtain the design scheme of the PEEK material filling body B3 (as shown in FIG. Figures 9 to 12 shown);

[0074] Then, the PEEK material filling body B3 is designed with retention holes 7, which correspond to the marked holes on the bone surface of the maxillary bone 9 one by one, and the design of the PEEK material filling body B3 is trimmed and the surface is smoothed to obtain the design of the PEEK material filling body C4 (as shown in FIG. Figures 13 to 16 shown);

[0075] Then, 3D printing is performed according to the design scheme of the PEEK material filling body C4 and the design scheme of the positioning guide plate 1;

[0076] Finally, the PEEK material filling body C4 and the positioning guide plate 1 are disinfected, sterilized and packaged.

[0077] During the operation, the positioning guide 1 is used to complete the bone block cutting and nail hole marking, and then the PEEK material filler C4 is used to complete the bone block fixation and bone morphology filling. The fit between the PEEK material filler C4 and the postoperative bone block is checked (such as Figures 17 to 20 shown).

[0078] In one embodiment, if Figures 1 to 24 As shown, the surgical area is the chin bone 10, and the bone cutting and moving surgery is the chin bone cutting and moving surgery: the design scheme of the manufactured PEEK material filling body C4, as shown in FIG. Figure 21 to Figure 24 The mental part 10 is a part of the mandible.

[0079] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only used to help understand the method and core ideas of the present invention. At the same time, for those skilled in the art, according to the ideas of the present invention, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A method for manufacturing a jaw fixation and morphological filling body, characterized in that: The following steps are involved: Preliminary design of jaw fixation and morphological filling body: Collect bone morphological imaging data of the patient's surgical area, and design PEEK material filling body A based on the bone morphological imaging data; Positioning guide design: The positioning guide is designed according to the bone morphology imaging data, and the bone cutting line and positioning holes are designed on the positioning guide. The bone cutting line is used to guide the bone saw to cut the surgical area, and the positioning hole is used to fix the positioning guide on the bone surface of the surgical area and leave a marking hole; Secondary design of jaw fixation and morphological filling body: According to the bone incision and movement surgery plan, the bone incision surgery is simulated to obtain the new bone morphology of the surgical area after the surgery, and the PEEK material filling body A is subtracted from the overlapping part of the free bone block with the new bone morphology to obtain the design plan of the PEEK material filling body B; Three-time design of jaw fixation and morphological filling body: Retention holes are designed on PEEK filling body B, and the retention holes correspond one to one with the marked holes on the bone surface after the simulated bone incision and movement surgery. The design of PEEK filling body B is trimmed at the edge and smoothed on the surface to obtain the design of PEEK filling body C. Production of the mandibular fixation and morphological filling body and the positioning guide: Production is carried out according to the design plan of the PEEK material filling body C and the design plan of the positioning guide.

2. The method for manufacturing a jaw fixation and form filling body according to claim 1, characterized in that: The three-dimensional imaging data of bone morphology is obtained by CT scanning the patient's surgical area.

3. The method for manufacturing a jaw fixation and form filling body according to claim 2, characterized in that: The three-dimensional impact data is imported into computer modeling software, and the positioning guide and the jaw fixation and morphological filling body are designed using computer modeling software.

4. The method for manufacturing a jaw fixation and form filling body according to claim 3, characterized in that: The computer modeling software is a combination of FreeForm Modeling Plus software and CAD software.

5. The method for manufacturing a jaw fixation and form filling body according to claim 1, characterized in that: The overlapping portion between the PEEK material filling body A and the free bone block is subtracted using Boolean operation.

6. The method for manufacturing a jaw fixation and form filling body according to claim 3, characterized in that: According to the model data output by the computer modeling software, the positioning guide plate and the PEEK material filling body C are manufactured by 3D printing.

7. The method for manufacturing a jaw fixation and form filling body according to claim 1, characterized in that: After the positioning guide plate and the PEEK material filling body C are manufactured, the positioning guide plate and the PEEK material filling body C are disinfected and sterilized.

8. The method for manufacturing a jaw fixation and form filling body according to claim 7, characterized in that: The disinfected and sterilized positioning guide plate and the PEEK material filling body C are packaged.

9. A method for manufacturing a jaw fixation and form filling body according to any one of claims 1 to 8, characterized in that: The surgical area is the maxillary bone, and the bone incision and movement surgery is the maxillary bone incision and movement surgery.

10. A method for manufacturing a jaw fixation and form filling body according to any one of claims 1 to 8, characterized in that: The operation area is the chin bone, and the bone cutting and moving operation is the chin bone cutting and moving operation.

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