Method for preparing a customized porous tmj prosthesis deposited with europium-doped black phosphorus

By combining a customized porous TMJ prosthesis with an europium-doped black phosphorus nanosheet coating, the problem of the inability to personalize existing TMJ prostheses is solved, achieving a stable connection between the prosthesis and bone tissue and promoting bone growth, thus improving the recovery of mandibular function.

CN120284543BActive Publication Date: 2025-11-28XIAN MEDICAL UNIV

Patent Information

Application Number
CN202411890482.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-12-20
Publication Date
2025-11-28
Estimated Expiration
2044-12-20

AI Technical Summary

Technical Problem

The existing TMJ prosthesis design cannot meet individual needs, resulting in failure of bone ingrowth, prosthesis loosening and dislocation, or bone resorption. Furthermore, it does not consider the reattachment of the lateral pterygoid muscle, which affects the recovery of mandibular function.

Method used

A customized porous TMJ prosthesis was fabricated using computer-aided design and 3D printing technology. Europium-doped black phosphorus nanosheet coatings were constructed in the porous region and combined with a polydopamine coating to achieve 3D fixation of the prosthesis to bone tissue and promote bone growth.

Benefits of technology

It improves the fit between the prosthesis and bone tissue, reduces intraoperative complications, promotes bone growth, avoids prosthesis loosening and dislocation and bone resorption, and ensures the recovery of mandibular function.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application discloses a preparation method of a customized porous TMJ prosthesis deposited with europium-doped black phosphorus nanosheets, and comprises the following steps: S1, CBCT is used to shoot medical image data, which is imported into Mimics software to reconstruct a model, the reconstructed model is imported into Geomagic software to simulate bone cutting, and a craniofacial model STL file is obtained; S2, TMJ prosthesis customization design is performed on the craniofacial model STL file; S3, SLM printing technology is adopted to perform 3D printing on the customized TMJ prosthesis model, and a prosthesis entity is obtained; and S4, a polydopamine europium-doped black phosphorus nanosheet surface coating is constructed on the porous region of the prosthesis entity model. The application realizes product customization by adopting computer-aided design and three-dimensional printing technology; the europium-doped black phosphorus nanosheet coating is constructed on the porous region of the prosthesis, the mandibular stump and the buccal region are promoted to grow into bone, the traditional "two-dimensional fixation" is changed into "three-dimensional fixation", and the limitation of screw loosening, falling off and bone resorption is got rid of.
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Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical treatment and relates to preparation of a TMJ prosthesis, in particular to a preparation method of a customized porous TMJ prosthesis deposited with europium-doped black phosphorus nanosheets. BACKGROUND

[0002] TMJ, i.e. temporomandibular joint, as the only movable joint in the oral and maxillofacial region, has a delicate anatomical structure and a complex movement function, and is one of the most active joints in the human body. Diseases such as joint ankylosis, trauma and tumor often cause morphological defects and loss of function of the temporomandibular joint, seriously affecting the quality of life of patients. How to perform ideal functional shape reconstruction, restore stable occlusal relationship and mandibular ramus height, etc. is a problem that must be faced and solved when repairing defects. Autologous bone transplantation can only achieve functional approximation and cannot achieve anatomical reconstruction, and is prone to complications in the donor area. Allogeneic bone transplantation mainly causes immune rejection and slow bone formation. Artificial temporomandibular joint has the advantages of rapid prototyping, precise anatomical design, minimally invasive, no need for secondary surgery, ease of use, stable effect, and immediate functional recovery, etc. Therefore, artificial temporomandibular joint for joint reconstruction has become one of the fastest developing joint reconstruction methods worldwide.

[0003] The existing TMJ prosthesis standard products on the market are mainly from abroad, and there are fewer finished product models, which cannot meet all clinical needs. Moreover, in the TMJ condylar prosthesis replacement system, most of the schemes adopt the contact mode of the condylar prosthesis surface and the osteotomy surface, and the remaining ones mainly rely on screws for retention, through the reserved retention holes to facilitate intraoperative operation, without personalized design according to the patient's jaw bone, which ultimately leads to the fact that the bone tissue of the bone section cannot grow into and ossify inside the condylar prosthesis through the porous structure or the early screw loosening due to the non-adhesion of the retention plate to the jaw bone, resulting in the phenomenon of prosthesis loosening and dislocation or late bone resorption. Moreover, the existing design rarely considers the reattachment of the lateral pterygoid muscle to the prosthesis, which is not conducive to the recovery of the mandibular function after the operation.

[0004] Based on the huge market demand for domestic individualized condylar prosthesis at present, it is an urgent task to develop a domestic, customized, and low-cost artificial TMJ prosthesis that meets the anatomical structure of the jaw bone of the Chinese people. However, research shows that only the microstructure of the prosthesis is processed, which still cannot meet the good integration between the implant and the bone. Therefore, it is also necessary to explore excellent bioactive materials for grafting. SUMMARY

[0005] The application aims to provide a preparation method of an europium-doped black phosphorus nanosheet deposited customized porous TMJ prosthesis, which realizes customized service by using computer-aided design and three-dimensional printing technology; in addition, the TMJ prosthesis is connected with the patient's autologous bone tissue in a porous structure, and the traditional "two-dimensional fixation" is changed into a new "three-dimensional fixation" mode, so as to get rid of the limitations of prosthesis loosening, falling off and bone absorption; meanwhile, the application constructs a europium-doped black phosphorus nanosheet coating in the porous area of the customized porous TMJ prosthesis, so as to promote the growth of bone tissue in the prosthesis after implantation, which is beneficial to the recovery of mandibular function after operation and effectively solves the problems in the prior art.

[0006] The technical scheme adopted by the application to achieve the above-mentioned purpose is as follows: a preparation method of an europium-doped black phosphorus nanosheet deposited customized porous TMJ prosthesis, comprising the following steps:

[0007] S1, medical image data of the patient's maxillofacial part is photographed by CBCT, and is imported into Mimics Medical software for craniofacial three-dimensional model reconstruction; then the craniofacial three-dimensional model is imported into Geomagic Wrap software, and according to the operation requirements of the temporomandibular joint reconstruction, the operation osteotomy is simulated at the temporomandibular joint of the patient's operation side to obtain the STL file of the craniofacial model;

[0008] S2, the customized design of the TMJ prosthesis is performed on the basis of the STL file of the craniofacial model obtained in step S1 to obtain the STL file of the customized TMJ prosthesis model;

[0009] S3, the STL file of the customized TMJ prosthesis model obtained in step S2 is manufactured by 3D printing by using SLM printing technology to obtain the entity model of the customized TMJ prosthesis;

[0010] S4, the polydopamine europium-doped black phosphorus nanosheet PDA@ (BP+Eu) surface coating is constructed on the porous area of the TMJ prosthesis entity model obtained in step S3, and the construction is as follows:

[0011] (1) constructing a polydopamine (PDA) coating on the porous area of the TMJ prosthesis entity model: the polydopamine (PDA) solution is introduced into the porous area of the TMJ prosthesis entity model for soaking, and after 24 hours of incubation using a shaking bed, the TMJ prosthesis is taken out and immersed in deionized water for oscillation for 2 minutes, and then dried in a vacuum environment at 40 DEG C for 6 hours, so as to fully remove the surface DA monomer and the unadhered PDA, and obtain the polydopamine-coated titanium alloy TMJ prosthesis (Ti-PDA) containing the polydopamine (PDA) coating;

[0012] (2) The titanium alloy TMJ prosthesis coated with polydopamine (Ti-PDA) is combined with the polydopamine doped europium black phosphorus nanosheet (PDA@ (BP+Eu)) to obtain the doped europium black phosphorus nanosheet deposited customized porous TMJ prosthesis.

[0013] A further technical solution of the present application is that in step S2, the customized design of the TMJ prosthesis comprises:

[0014] (1) The condylar prosthesis structure parameter determination: the external entity thickness simulates the cortical bone thickness, which is obtained by multi-point sampling measurement on the CT data of the patient; the internal part is a rhombus or gradient porous structure, the pore size gradually decreases from the prosthesis bone contact end to the condylar head lower end, and the porosity is 70%;

[0015] (2) The condylar prosthesis head design: the shape is a combination of a hemisphere and a cylinder, and the ball diameter and the cylinder diameter are consistent;

[0016] (3) The condylar prosthesis neck porous design: a porous structure is arranged at the joint pterygoid fossa of the mandible anterior medial surface and the medial condyle, and the porosity is 70% for the attachment of the lateral pterygoid muscle;

[0017] (4) The condylar prosthesis retention wing plate design: the retention handle length and width are based on the 3D model data of the mandibular ramus, the shape is "V" shape, the retention handle thickness is 2 mm, the inner side between the upper and lower nail holes of the retention handle is designed as a porous area, the hole depth is 0.5 mm, and the hole diameter is consistent with the bone section contact parameter;

[0018] (5) The condylar prosthesis retention nail hole design: the retention nail hole diameter is 2 mm, the length is determined according to the retention handle and the thickness of the bilateral cortical bone, there are 2 retention nails above and below, the retention nails are fixed on the lateral surface of the mandible along the posterior margin and the lower margin of the mandible, and the working end of the retention nail is provided with a sharp thread;

[0019] (6) The joint socket design: the joint socket prosthesis is designed on the joint eminence slightly in front of the temporal bone joint socket when the mandible remains stationary, the joint socket material is ultra-high molecular weight polyethylene, the joint socket is fixed to the zygomatic arch by 4 titanium nails in an external contact mode, the socket part matches the condylar head, and the rear part is provided with a rear lip to avoid condylar posterior dislocation, and the joint socket prosthesis thickness is at least 3 mm.

[0020] A further technical solution of the present application is that in step S3, when the SLM printing technology is used for 3D printing of the digital model of the customized TMJ prosthesis, the printing material selected is implant-grade Ti6Al4V metal powder, the laser spot diameter is 70 μm, the thickness of each layer is 50 μm, the scanning speed is 0.6 m / s, and the laser power is 200 W; after the 3D printing is completed, post-processing operation is performed thereon and high-pressure sterilization is carried out, so as to complete the manufacturing of the Ti6Al4V customized porous titanium alloy TMJ prosthesis.

[0021] A further technical solution of the present application is that in step S4, the polydopamine (PDA) solution synthesis method is as follows:

[0022] 0.06 g of tris (hydroxymethyl) aminomethane (Tris) is weighed into 50 mL of pure water, magnetically stirred for 10 minutes, and hydrochloric acid is used to adjust the pH value of the tris (hydroxymethyl) aminomethane (Tris) buffer, so that the pH value is 8.5;

[0023] Then 0.1 g of dopamine (DA) powder is added to the tris (hydroxymethyl) aminomethane (Tris) buffer, stirred for 5 minutes, and a polydopamine (PDA) solution with a concentration of 2 mg / mL is obtained. When the color changes to light yellow, it indicates that the polydopamine (PDA) solution synthesis is completed.

[0024] A further technical solution of the present application is that in step S4, the preparation method of the polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) is as follows:

[0025] First, 10~20 mL of black phosphorus nanosheet (BPNS) suspension with a concentration of 0.2 mg / mL is placed in a centrifugal tube, the speed is 15000 r / min, and frozen centrifugation is carried out for 20 minutes, the supernatant is discarded, and washing is carried out;

[0026] Then 10~20 mL of acetonitrile solution is added, and then 25~50 mg of europium nitrate hexahydrate is added, ultrasonic is carried out for 3 minutes, closed and dark stirring is carried out for 12 hours, frozen centrifugation is carried out at a speed of 12000 r / min for 15 minutes, and washing is carried out to obtain europium-doped black phosphorus nanosheet (BP+Eu);

[0027] Finally, 10~20 mL of polydopamine (PDA) solution with a concentration of 2 mg / mL is slowly added, closed and dark oscillation is carried out for 2 hours, and after centrifugation and washing again, polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) is obtained.

[0028] A further technical solution of the present application is that in step S4, the composite method of the polydopamine coating titanium alloy TMJ prosthesis (Ti-PDA) and the polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) is as follows:

[0029] First, the polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) is dispersed in deionized water, and the deionized water is introduced into the porous area of the polydopamine coated titanium alloy TMJ prosthesis (Ti-PDA), the bubbles in the pores of the polydopamine coated titanium alloy TMJ prosthesis (Ti-PDA) are gently blown by a pipette, the polydopamine coated titanium alloy TMJ prosthesis (Ti-PDA) is fully contacted with the polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) liquid, after 24 hours of incubation in a shaking bed, it is washed with deionized water, the TMJ prosthesis is taken out, dried in a 40℃ oven for 1-2 hours, finally sterilized and sealed, to obtain a europium doped black phosphorus nanosheet deposited customized porous TMJ prosthesis.

[0030] The preparation method of the europium doped black phosphorus nanosheet deposited customized porous TMJ prosthesis has the following beneficial effects due to the adoption of the above technical scheme:

[0031] 1. The computer aided design and three-dimensional printing technology are adopted in the present application to print a titanium alloy TMJ prosthesis which matches the morphology of the patient's own mandible, so that the prosthesis jaw is more fitted, a large amount of bone tissue does not need to be removed during the operation to adapt to the shape of the prosthesis, the occurrence of intraoperative and postoperative complications is effectively reduced, the operation time is shortened, and the best stress distribution can be achieved after implantation.

[0032] 2. The europium doped black phosphorus nanosheet coating is constructed in the porous area of the customized porous TMJ prosthesis, researches show that doping Eu 3+ or Eu compound nanoparticles in biomaterials can adjust the immune microenvironment and promote the osteogenic differentiation of bone marrow mesenchymal stem cells (BMSCs), angiogenesis of human umbilical vein endothelial cells (HUVECs) and other properties, however, the bioactive Eu 3+ cannot be well integrated with the scaffold in the form of an element, and the black phosphorus nanosheet can be used as an excellent carrier for material delivery due to its unique layered structure and high specific surface area; PDA is a substance produced by self-polymerization of dopamine monomers (DA) in a weak alkaline environment, which has strong adhesion to almost all materials and has the ability to recruit stem cells; therefore, by constructing a europium doped black phosphorus nanosheet coating in the porous area of the customized porous TMJ prosthesis, the purpose of promoting the growth of bone tissue in the prosthesis after implantation of the prosthesis is achieved, which is beneficial to the recovery of mandibular function after the operation.

[0033] 3. The TMJ prosthesis of the present application adopts a porous structure to connect with the patient's autologous bone tissue, changes the traditional "two-dimensional fixation" into a new "three-dimensional fixation" mode, so that the main stress of the TMJ prosthesis is changed to the internal structure and bone tissue, thereby getting rid of the limitations of prosthesis loosening, falling off and bone resorption.

[0034] The preparation method of the TMJ prosthesis with the deposited europium-doped black phosphorus nanosheet will be further described below in combination with the accompanying drawings and examples. BRIEF DESCRIPTION OF DRAWINGS

[0035] Figure 1 is a schematic view of the structure of the TMJ prosthesis designed by the preparation method of the TMJ prosthesis with the deposited europium-doped black phosphorus nanosheet after being assembled with the patient's mandible;

[0036] Figure 2 is an STL model of the mandible model in step S2 of the present application;

[0037] Figure 3 is a front view of the customized TMJ prosthesis;

[0038] Figure 4 is a rear view of the customized TMJ prosthesis;

[0039] BRIEF DESCRIPTION OF DRAWINGS DETAILED DESCRIPTION

[0040] As shown in Figures 1 to 4 , the preparation method of the TMJ prosthesis with the deposited europium-doped black phosphorus nanosheet includes the following steps:

[0041] S1, medical image data of the patient's maxillofacial region is photographed by CBCT, and is imported into Mimics Medical 21.0 software (Materialise, Belgium) for craniofacial three-dimensional model reconstruction; then the craniofacial three-dimensional model is imported into GeomagicWrap 2017 software (3D Systems, USA), and according to the surgical requirements of the temporomandibular joint reconstruction, the surgical osteotomy at the patient's surgical side temporomandibular joint is simulated to obtain an STL file of the craniofacial model (as shown in Figure 2 );

[0042] S2, on the basis of the STL file of the craniofacial model obtained in step S1, the customization design of the TMJ prosthesis is carried out to obtain an STL file of the customized TMJ prosthesis model (as shown in Figure 3 , Figure 4 ); it should be noted that in this step, the customization design of the TMJ prosthesis includes: 1) determination of the condylar prosthesis structure parameters; 2) design of the condylar prosthesis head; 3) porous design of the condylar neck; 4) design of the condylar prosthesis retention wing plate; 5) design of the condylar prosthesis retention pin hole; 6) design of the joint socket;

[0043] S3, using SLM printing technology to print the STL file of the customized TMJ prosthesis model obtained in step S2, to obtain a physical model of the customized TMJ prosthesis;

[0044] S4, constructing a polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) surface coating on the porous region of the TMJ prosthesis physical model obtained in step S3, specifically as follows:

[0045] (1) Constructing a polydopamine (PDA) coating on the surface of the porous region of the TMJ prosthesis physical model: introduce polydopamine (PDA) solution into the porous region of the TMJ prosthesis physical model for soaking, incubate using a shaker for 24 hours, then take out the TMJ prosthesis and immerse it in deionized water for oscillation for 2 minutes, then dry the TMJ prosthesis in a vacuum environment at 40°C for 6 hours, to fully remove the unaggregated DA monomers and unadhered polydopamine (PDA) from its surface, to obtain a polydopamine-coated titanium alloy TMJ prosthesis (Ti-PDA) containing a polydopamine (PDA) coating;

[0046] (2) Compound the polydopamine-coated titanium alloy TMJ prosthesis (Ti-PDA) with polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu), to obtain a europium black phosphorus nanosheet deposited customized porous TMJ prosthesis.

[0047] Further, in step S2, the customized design of the TMJ prosthesis includes:

[0048] (1) Determining the condyle prosthesis structure parameters: the external entity thickness simulates the cortical bone thickness, which is obtained by multi-point sampling measurement on the patient's CT data, with a thickness of about 1 mm; the interior is a rhombus or gradient porous structure, with a pore size gradually decreasing from the prosthesis bone contact end to the condyle head lower end, in this embodiment, the pore size gradually decreases from 650um to 500um from the prosthesis bone contact end to the condyle head lower end, and the porosity is 70%;

[0049] (2) Design of condyle prosthesis head: the shape is a combination of a hemisphere and a cylinder, with the same ball diameter and cylinder diameter; in this embodiment, the ball diameter and cylinder diameter are both 8 mm, and the overall height is 7 mm;

[0050] (3) Porous design of condyle neck: porous structure is provided at the joint pterygoid fossa (upper inside of mandibular notch) of the anterior and medial surface of the mandible (above the mandibular foramen) and the medial side of the condyle, with a total area of 2.0±0.4 cm 2 , i.e.: pterygoid fossa 1.4±0.3 cm 2 , medial side of condyle 0.6±0.2 cm 2 ; the pore size is 500um and the porosity is 70%, for attachment of the lateral pterygoid muscle;

[0051] (4) Condyle prosthesis retention wing plate design: the length and width of the retention stem are based on the 3D model data of the mandibular ramus, the shape is "V" shape, and the thickness of the retention stem is 2 mm. The inner side between the upper and lower pin holes of the condyle prosthesis retention stem is designed as a porous area in the range of 1*1.5 cm (avoiding the safety area of the pin hole), the hole depth is 0.5 mm, and the hole diameter is consistent with the parameters at the bone section contact;

[0052] (5) Condyle prosthesis retention pin hole design: the retention pin hole diameter is 2 mm, and the length is determined according to the retention stem and the thickness of the bilateral cortical bone. There are 2 retention pins above and below, in order to avoid damaging the mandibular nerve and the mandibular canal, the retention pin is fixed on the lateral surface of the mandible along the posterior margin and the lower margin of the mandible, and the initial pre-tension is 100 N. The working end of the retention pin is provided with a sharp thread; in this embodiment, the retention pin is a titanium pin;

[0053] (6) Joint socket design: the joint socket prosthesis is designed on the articular eminence slightly in front of the temporal bone joint socket when the mandible is kept still. The joint socket material is ultra-high molecular polyethylene, and the joint socket prosthesis is fixed on the zygomatic arch by 4 titanium pins in an external contact manner. The socket part matches the condyle head and is provided with a rear lip at the rear part to avoid condyle posterior dislocation. The joint socket prosthesis thickness is at least 3 mm, and the average depth is 4.32 mm.

[0054] In step S3, when the digital model of the customized TMJ prosthesis is 3D printed and manufactured by using the SLM printing technology, the printing material selected is implant-grade Ti6Al4V metal powder, the laser spot diameter is 70 μm, the thickness of each layer is 50 μm, the scanning speed is 0.6 m / s, and the laser power is 200 W. After 3D printing is completed, sand blasting polishing post-processing operation is performed and high-pressure sterilization is carried out, and the manufacturing of the Ti6Al4V customized porous titanium alloy TMJ prosthesis is completed. In addition, the forming process of the SLM printing technology is prior art, which will not be described in detail here.

[0055] In step S4, the polydopamine (PDA) solution synthesis method is as follows:

[0056] 0.06 g of tris-hydroxymethyl aminomethane (Tris) is weighed into 50 mL of pure water, magnetically stirred for 10 minutes, and hydrochloric acid is used to adjust the pH value of the tris-hydroxymethyl aminomethane (Tris) buffer solution, so that the pH value is 8.5;

[0057] Then 0.1 g of dopamine (DA) powder is added to the tris-hydroxymethyl aminomethane (Tris) buffer solution, stirred for 5 minutes, and a polydopamine (PDA) solution with a concentration of 2 mg / mL is obtained. When the color changes to light yellow, it indicates that the polydopamine (PDA) solution synthesis is completed.

[0058] In step S4, the preparation method of the polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) is as follows:

[0059] Firstly, 10~20 mL of black phosphorus nanosheet (BPNS) suspension with a concentration of 0.2 mg / mL was taken into a centrifugal tube, and centrifugal freezing was carried out at a speed of 15000 r / min for 20 minutes, the supernatant was discarded, and washing was carried out;

[0060] Then, 10~20 mL of acetonitrile solution was added, 25~50 mg of europium nitrate hexahydrate was added, ultrasonic treatment was carried out for 3 minutes, the mixture was stirred in dark and sealed for 12 hours, centrifugal freezing was carried out at a speed of 12000 r / min for 15 minutes, and washing was carried out to obtain europium-doped black phosphorus nanosheets (BP+Eu);

[0061] Finally, 10~20 mL of polydopamine (PDA) solution with a concentration of 2 mg / mL was slowly added, the mixture was oscillated in dark and sealed for 2 hours, centrifugal freezing and washing were carried out again to obtain the polydopamine-doped europium black phosphorus nanosheet PDA@ (BP+Eu).

[0062] It should be noted that the polydopamine-doped europium black phosphorus nanosheet PDA@ (BP+Eu) of the present application should be stored in dark at 4 ℃.

[0063] In step S4, the compounding method of the polydopamine-coated titanium alloy TMJ prosthesis (Ti-PDA) and the polydopamine-doped europium black phosphorus nanosheet PDA@ (BP+Eu) is as follows:

[0064] Firstly, the polydopamine-doped europium black phosphorus nanosheet PDA@ (BP+Eu) was dispersed in deionized water to form a polydopamine-doped europium black phosphorus nanosheet PDA@ (BP+Eu) liquid, and the polydopamine-doped europium black phosphorus nanosheet PDA@ (BP+Eu) liquid was introduced into the porous region of the polydopamine-coated titanium alloy TMJ prosthesis (Ti-PDA), the bubbles in the pores of the polydopamine-coated titanium alloy TMJ prosthesis (Ti-PDA) were gently blown by a pipette, the polydopamine-coated titanium alloy TMJ prosthesis (Ti-PDA) was fully contacted with the polydopamine-doped europium black phosphorus nanosheet PDA@ (BP+Eu) liquid, after incubation in a shaking bed for 24 hours, deionized water was used for cleaning, the TMJ prosthesis was taken out, dried in a 40 ℃ oven for 1~2 hours, and finally sterilized by Co60 irradiation and sealed to obtain a europium-doped black phosphorus nanosheet deposited customized porous TMJ prosthesis, and the TMJ prosthesis was stored in a 4 ℃ refrigerator for standby use.

[0065] The present application constructs a europium-doped black phosphorus nanosheet coating on the surface of a customized porous TMJ prosthesis, and researches show that the doping of Eu 3+Or Eu compound nanoparticles can adjust the immune microenvironment and promote the osteogenic differentiation of bone marrow mesenchymal stem cells (BMSCs), the angiogenesis of human umbilical vein endothelial cells (HUVECs) and other properties, however, the elemental Eu3+ cannot be well integrated with the scaffold in the form of an element, and the black phosphorus nanosheet can be used as an excellent carrier for material delivery due to its unique layered structure and high specific surface area; the PDA is a substance generated by self-polymerization of dopamine monomers (DA) in a weak alkaline environment, has strong adhesion to almost all materials and has the ability to recruit stem cells; therefore, the Eu-doped black phosphorus nanosheet coating is constructed on the porous area of the customized porous TMJ prosthesis, so that the growth of bone tissue in the prosthesis can be promoted after the prosthesis is implanted, and the postoperative mandibular function is recovered.

[0066] The above examples are only the preferred embodiments of the present application, and the structure of the present application is not limited to the forms listed in the above examples, and any modifications, equivalent replacements and the like made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A method for the preparation of a custom-made porous TMJ prosthesis deposited with europium-doped black phosphorus, characterized by: The method comprises the following steps: S1, CBCT is used to shoot medical image data of the patient's maxillofacial part, and is imported into Mimics Medical software for reconstruction of a craniofacial three-dimensional model; then the craniofacial three-dimensional model is imported into Geomagic Wrap software, and according to the surgical requirements of the reconstruction of the temporomandibular joint, the surgery osteotomy at the temporomandibular joint of the patient's surgery side is simulated to obtain an STL file of the craniofacial model; S2, based on the STL file of the craniofacial model obtained in step S1, customized design of the TMJ prosthesis is performed to obtain an STL file of the customized TMJ prosthesis model; S3, SLM printing technology is used to 3D print and manufacture the customized TMJ prosthesis model STL file obtained in step S2 to obtain a physical model of the customized TMJ prosthesis; S4, the porous area of the TMJ prosthesis physical model obtained in step S3 is constructed with a polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) surface coating, specifically as follows: (1) Constructing a polydopamine (PDA) coating on the porous area of the TMJ prosthesis physical model: introduce the polydopamine (PDA) solution into the porous area of the TMJ prosthesis physical model for immersion, incubate for 24 hours using a shaking bed, then take out the TMJ prosthesis and immerse it in deionized water for oscillation for 2 minutes, and then dry it in a vacuum environment at 40 ℃ for 6 hours to fully remove the surface unaggregated DA monomers and unadhered PDA, thereby obtaining a polydopamine-coated titanium alloy TMJ prosthesis (Ti-PDA) with a polydopamine (PDA) coating; (2) Compound the polydopamine-coated titanium alloy TMJ prosthesis (Ti-PDA) with the polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) to obtain a europium black phosphorus nanosheet deposited customized porous TMJ prosthesis; In step S2, the customized design of the TMJ prosthesis comprises: (1) Condyle prosthesis structure parameter determination: the external entity thickness simulates the cortical bone thickness, which is obtained by multi-point sampling measurement on the patient's CT data; the internal part is a rhombus or a gradient porous structure, the pore size gradually decreases from the prosthesis bone contact end to the condylar head lower end, and the porosity is 70%; (2) Condyle prosthesis head design: the shape is a combination of a hemisphere and a cylinder, and the ball diameter and the cylinder diameter are consistent; (3) Condyle neck porous design: a porous structure is provided at the joint wing muscle fossa of the anterior and medial surface of the mandible and the medial side of the condyle, and the porosity is 70% for the attachment of the lateral pterygoid muscle; (4) Condyle prosthesis retention wing plate design: the length and width of the retention stem are based on the 3D model data of the mandibular ramus, the shape is "V-shaped", and the retention stem thickness is 2mm, the inner side between the upper and lower nail holes of the retention stem is designed as a porous area, the hole depth is 0.5mm, and the hole diameter is consistent with the bone section contact parameters; (5) Condyle prosthesis retention nail hole design: the retention nail hole diameter is 2mm, and the length is determined according to the thickness of the retention stem and the bilateral cortical bone, there are 2 retention nails above and below, the retention nails are fixed on the lateral surface of the mandible along the posterior and lower edges of the mandible, and the working end of the retention nail is provided with a sharp thread. (6) The design of the joint socket: the joint socket prosthesis is designed on the eminence of the glenoid fossa of the temporal bone when the mandible is kept still, the material of the joint socket is ultra-high molecular polyethylene, and the joint socket is fixed on the zygomatic arch by 4 titanium nails in an external contact mode, the socket part is matched with the condylar head, and the back part is provided with a back lip to avoid the posterior dislocation of the condylar head, and the thickness of the joint socket prosthesis is at least 3 mm.

2. The method of claim 1, wherein the method of depositing a custom porous TMJ prosthesis with Eu-doped black phosphorene nanosheets is characterized by: In step S3, when the digital model of the customized TMJ prosthesis is 3D printed and manufactured by using the SLM printing technology, the printing material selected is implant-grade Ti6Al4V metal powder, the laser spot diameter is 70 μm, the thickness of each layer is 50 μm, the scanning speed is 0.6 m / s, and the laser power is 200 W; after the 3D printing is completed, post-processing operation is performed thereon and high-pressure sterilization is carried out, thereby completing the manufacturing of the Ti6Al4V customized porous titanium alloy TMJ prosthesis.

3. The method of claim 1, wherein the method of depositing a custom porous TMJ prosthesis with Eu-doped black phosphorene nanosheets is characterized by: In step S4, the synthesis method of the polydopamine (PDA) solution is as follows: 0.06 g of tris-hydroxymethyl aminomethane (Tris) is weighed and dissolved in 50 mL of pure water, and magnetic stirring is performed for 10 minutes; hydrochloric acid is used to adjust the pH value of the tris-hydroxymethyl aminomethane (Tris) buffer solution, so that the pH value is 8.5; Then, 0.1 g of dopamine (DA) powder is added to the tris-hydroxymethyl aminomethane (Tris) buffer solution, and stirring is performed for 5 minutes to obtain a polydopamine (PDA) solution with a concentration of 2 mg / mL; when the color changes to light yellow, it indicates that the synthesis of the polydopamine (PDA) solution is completed.

4. The method of claim 1, wherein the method of depositing a custom porous TMJ prosthesis with Eu-doped black phosphorene nanosheets is characterized by: In step S4, the preparation method of the polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) is as follows: First, 10~20 mL of black phosphorus nanosheet (BPNS) suspension with a concentration of 0.2 mg / mL is placed in a centrifuge tube, and centrifugal freezing is performed at a speed of 15000 r / min for 20 minutes; the supernatant is discarded, and washing is performed; Then, 10~20 mL of acetonitrile solution is added, and 25~50 mg of europium nitrate hexahydrate is added, ultrasonic is performed for 3 minutes, and stirring is performed in the dark for 12 hours; centrifugal freezing is performed at a speed of 12000 r / min for 15 minutes, and washing is performed to obtain europium-doped black phosphorus nanosheets (BP+Eu); Finally, 10~20 mL of polydopamine (PDA) solution with a concentration of 2 mg / mL is slowly added, and the mixture is oscillated in the dark for 2 hours; after centrifugation and washing, polydopamine doped europium black phosphorus nanosheets PDA@ (BP+Eu) are obtained.

5. The method of claim 1, wherein the method of depositing a custom porous TMJ prosthesis with Eu-doped black phosphorene nanosheets is characterized by: In step S4, the compounding method of the polydopamine coated titanium alloy TMJ prosthesis (Ti-PDA) and the polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) is as follows: First, the polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) is dispersed in deionized water, and the deionized water is introduced into the porous area of the polydopamine coated titanium alloy TMJ prosthesis (Ti-PDA), and the bubbles in the pores of the polydopamine coated titanium alloy TMJ prosthesis (Ti-PDA) are gently blown by a pipette, so that the polydopamine coated titanium alloy TMJ prosthesis (Ti-PDA) is in full contact with the polydopamine doped europium black phosphorus nanosheet PDA@ (BP+Eu) liquid, and after 24 hours of incubation in a shaking bed, it is washed with deionized water, the TMJ prosthesis is taken out, dried in a 40℃ oven for 1-2 hours, and finally sterilized and sealed to obtain a europium-doped black phosphorus nanosheet deposited customized porous TMJ prosthesis.

Citation Information

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