Prosthesis material, nose prosthesis containing prosthesis material and preparation method

Abstract

The invention relates to a prosthesis material, a nose prosthesis containing the same and a preparation method. The prosthesis material comprises 20-90 parts of a degradable high polymer material and 10-80 parts of an inorganic material, the degradable high polymer material comprises any one or a combination of at least two of polycaprolactone, polylactic acid, polyurethane or polyether-ether-ketone; the inorganic material comprises tricalcium phosphate and / or hydroxyapatite. By designing and preparing the composite wire rod in a specific proportion, the flexibility and ductility of the prosthesis are improved, and enough mechanical strength and ideal osseointegration capability can be provided; and in combination with a personalized design process, precise customization and efficient manufacturing of the nose prosthesis are realized.

Description

Technical Field

[0001] The present invention relates to the technical field of medical materials, and in particular to a prosthesis material, a nasal prosthesis containing the same, and a preparation method thereof. Background Art

[0002] The main application areas of medical prostheses include: in the field of degenerative arthritis treatment (total knee replacement, total hip replacement), vertebroplasty, cosmetic surgery and oral field. Different treatment application fields also have some special requirements for the performance of prostheses. The types of rhinoplasty prostheses in the existing technology mainly include: (1) Silicone prostheses: They are widely used for their non-toxicity, good biocompatibility, easy shaping and moderate price. However, silicone prostheses may have potential risks such as light transmission, displacement, infection and rejection, and their shape is fixed, making it difficult to achieve completely personalized matching. (2) Expanded polytetrafluoroethylene (ePTFE) prostheses: They have a microporous structure that allows the surrounding tissue to grow in, enhancing the combination of the prosthesis and tissue. However, they are expensive, require strict surgical operation techniques, and are difficult to remove once complications occur. (3) Autologous cartilage transplantation: The patient's own ear cartilage or rib cartilage is used for transplantation, which has excellent biocompatibility and natural effect. However, the surgery is traumatic, complications may occur in the donor area, and the cartilage carving technology is high, making it difficult to mass produce. (4) Injectable fillers: such as hyaluronic acid, artificial bone powder, collagen, etc., are used for non-surgical rhinoplasty or fine-tuning. The advantages are simple operation and quick recovery, but the effect is not permanent and needs to be re-injected regularly. Improper injection may cause nodules, inflammation and other problems.

[0003] The preparation methods of medical prostheses usually include traditional processes such as mold casting, mechanical carving or injection molding. Although these methods are mature, they are often difficult to achieve highly personalized customization, especially for the accurate replication of complex anatomical structures. In recent years, the application of 3D printing technology in the preparation of personalized rhinoplasty prostheses has attracted increasing attention. By collecting facial CT or magnetic resonance imaging (MRI) data of patients, three-dimensional reconstruction and design are performed, and then a 3D printer is used to deposit materials layer by layer to build a prosthesis that accurately matches the patient's nasal anatomical structure. The advantages of this technology are: (1) precise personalization, which can be customized according to the specific nasal morphology of each patient to achieve the best aesthetic effect and functional restoration; (2) reducing surgical operations, eliminating the intraoperative prosthesis "carving" link, simplifying the traditional processing process, shortening the preparation cycle, and improving production efficiency; (3) material diversity, supporting the use of a variety of biomedical materials, including biodegradable materials or bioactive ceramic materials.

[0004] Although 3D printing technology has shown great potential in the manufacture of personalized rhinoplasty prostheses, the following problems still exist: (1) Insufficient material properties. It is difficult for a single material to simultaneously meet the multiple requirements of the prosthesis, such as mechanical properties, bioactivity, and degradation characteristics; (2) Difficulty in personalized customization. Although 3D printing can theoretically achieve high personalization, in actual operation, the complex nasal anatomical structure, individual differences, and the challenges of different material properties required for specific parts still limit the precision of personalized design and manufacturing; (3) Timeliness. For example, with SLA and SLS 3D printing methods, the prosthesis often needs to undergo a series of post-processing processes, including cleaning, polishing, disinfection, and possible heat treatment or coating to ensure its biocompatibility and durability.

[0005] Therefore, how to achieve efficient, rapid, high-precision, and personalized prosthesis customization while improving the application performance of the prosthesis has become a problem that needs to be solved urgently. Summary of the invention

[0006] In order to solve the above technical problems, the present invention provides a prosthetic material, a nasal prosthesis containing the same and a preparation method. By designing and preparing composite wires in specific proportions and combining a personalized design process, precise customization and efficient manufacturing of nasal prostheses are achieved. This prosthesis not only has a personalized appearance that is highly matched with the patient's nose, but also due to its specific structural design and the use of bioactive materials, it is expected to improve the integration of the prosthesis with surrounding tissues, reduce complications, and increase the success rate of surgery and patient satisfaction.

[0007] To achieve this object, the present invention adopts the following technical solutions:

[0008] In a first aspect, the present invention provides a prosthetic material, which comprises, by weight, 20-90 parts of a degradable polymer material and 10-80 parts of an inorganic material;

[0009] The degradable polymer material includes any one of polycaprolactone (PCL), polylactic acid (PLA), polyurethane or polyetheretherketone or a combination of at least two thereof;

[0010] The inorganic material includes tricalcium phosphate (TCP) and / or hydroxyapatite (HA).

[0011] The prosthetic material provided by the present invention includes a specific ratio of degradable polymer materials and inorganic materials. The degradable polymer material is used as a matrix material to provide good biodegradability and plasticity. During the decomposition process, it can stimulate the regeneration of surrounding tissues and help the natural healing and remodeling of nasal tissues, which can accelerate the recovery process to a certain extent and promote a more natural result. The inorganic material is used as a reinforcing agent to give the prosthesis the required biological activity and bone conduction properties, and cooperates with the degradable polymer material to form a composite wire with suitable mechanical strength and degradation rate.

[0012] Wherein, in parts by weight, the degradable polymer material is 20-90 parts, for example, 25 parts, 30 parts, 40 parts, 50 parts, 60 parts, 70 parts or 80 parts.

[0013] In parts by weight, the inorganic material is 10-80 parts, for example, 15 parts, 20 parts, 30 parts, 40 parts, 50 parts, 60 parts or 70 parts.

[0014] Preferably, the degradable polymer material includes polycaprolactone, and the inorganic material includes tricalcium phosphate.

[0015] As a preferred technical solution of the present invention, the prosthetic material includes a combination of polycaprolactone (PCL) and tricalcium phosphate (TCP). PCL is a thermoplastic polymer with good biocompatibility, degradability, and low immunogenicity, and is widely used in the fields of drug release carriers, tissue engineering scaffolds, etc. Its degradation products can be excreted from the body through normal metabolic pathways, and the degradation rate can be adjusted, which is suitable for long-term support or short-term filling needs. TCP is an important bioactive ceramic material with good biocompatibility, osteoconductivity and osteoinductivity, which can promote new bone formation and eventually be replaced by autologous bone. The two are compounded to further improve the flexibility and ductility of the prosthesis, and can provide sufficient mechanical strength and ideal bone integration ability, overcoming the limitations of a single material.

[0016] Preferably, the weight average molecular weight of the degradable polymer material is 60,000-100,000 g / mol, for example, 65,000 g / mol, 70,000 g / mol, 75,000 g / mol, 80,000 g / mol, 85,000 g / mol, 90,000 g / mol or 95,000 g / mol.

[0017] Preferably, the particle size of the inorganic material is 0.5-5 μm, for example, 0.8 μm, 1 μm, 1.5 μm, 2 μm, 3 μm or 4 μm.

[0018] In a second aspect, the present invention provides a nasal prosthesis, wherein the nasal prosthesis is prepared from the prosthesis material described in the first aspect.

[0019] Preferably, the interior of the nasal prosthesis is a porous structure.

[0020] As a preferred technical solution of the present invention, the interior of the prosthesis is designed to be porous, imitating the honeycomb structure of natural bones to promote the growth of blood vessels and cells and enhance the integration of the prosthesis with surrounding tissues. The porosity and pore size can be optimized according to clinical needs and material properties, ensuring mechanical stability and facilitating new bone formation.

[0021] Preferably, the surface of the nasal prosthesis has a rough texture.

[0022] As a preferred technical solution of the present invention, the surface of the prosthesis is designed with a rough texture to simulate the microstructure of the natural bone surface, which is conducive to cell adhesion and proliferation, and further improves the biocompatibility and stability of the prosthesis. The texture design can also be locally adjusted as needed, such as adding grooves or protrusions at the contact point with the nasal cartilage to enhance the mechanical locking between the prosthesis and the cartilage.

[0023] Preferably, the nasal prosthesis includes a nasal root, a nasal dorsum, a nasal tip, a columella and a columella base.

[0024] Preferably, the shape of the nasal root includes a semi-elliptical shape, a fishbone shape or a fishtail shape.

[0025] In the present invention, the root of the nose is the starting point of the nose bridge and is located between the two eyebrows, and its structural design needs to consider the natural transition with the forehead.

[0026] Preferably, the porosity of the nasal root is 50-90%, for example, it may be 55%, 60%, 65%, 70%, 75%, 80% or 85%, etc.

[0027] Preferably, the thickness of the nasal root is 0.3-1 mm, for example, it can be 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm or 0.9 mm.

[0028] Preferably, the shape of the nose bridge includes any one of willow-leaf shape, fishtail shape, plate shape, I shape, L shape or T shape.

[0029] In the present invention, the prosthesis covers the upper part of the nose bridge, extending from the root of the nose to two-thirds of the nose bridge, improving the straightness and height of the nose bridge, but not touching the nose tip area. The shape is customized according to the patient's individuality, generally with a wide middle and narrow ends. The prosthesis is laid along the natural curve of the nasal dorsum, aiming to enhance the line sense of the nose bridge and make the nose bridge look more three-dimensional and stylish.

[0030] Preferably, the nose bridge is a double-layer structure.

[0031] Preferably, the porosity of the nasal dorsum is 10-90%, for example, it may be 15%, 20%, 30%, 40%, 50%, 60%, 70% or 80%.

[0032] Preferably, the thickness of each layer of the nasal dorsum is independently 1-5 mm, for example, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm or 4.5 mm.

[0033] Preferably, the nose tip is a hollow T-shaped structure.

[0034] Preferably, the outer portion of the nose tip is spherical, which can increase the contact surface between the nose tip and the human body.

[0035] Preferably, the porosity of the nose tip is 20-90%, for example, it may be 25%, 30%, 40%, 50%, 60%, 70% or 80%.

[0036] Preferably, the thickness of the nose tip is 1-3 mm, for example, it may be 1.2 mm, 1.5 mm, 1.8 mm, 2 mm, 2.2 mm, 2.5 mm or 2.8 mm.

[0037] Preferably, the columella is a mesh structure.

[0038] In the present invention, the columella is a low-density printed mesh structure, which can be matched with the columella base. A slot is provided in the middle to form a mortise and tenon structure with the anterior nasal spine, generally presenting a "human" shaped bracket stuck in the anterior nasal spine.

[0039] Preferably, the porosity of the columella is 10-90%, for example, it may be 15%, 20%, 30%, 40%, 50%, 60%, 70% or 80%.

[0040] Preferably, the thickness of the columella is 0.1-10 mm, for example, 0.5 mm, 1 mm, 2 mm, 3 mm, 5 mm or 8 mm.

[0041] Preferably, the columella base is in sheet shape.

[0042] In the present invention, the width of the columella base is 1-2 mm above the tooth root (for example, it can be 1.1 mm, 1.3 mm, 1.5 mm, 1.7 mm or 1.9 mm, etc.), the outer edge does not exceed the outer vertical line of the nose sill, and the thickness is uneven.

[0043] Preferably, the porosity of the columella base is 10-90%, for example, it may be 15%, 20%, 30%, 40%, 50%, 60%, 70% or 80%.

[0044] Preferably, the thickness of the columella base is 1-3 mm, for example, it may be 1.2 mm, 1.5 mm, 1.8 mm, 2 mm, 2.2 mm, 2.5 mm or 2.8 mm.

[0045] Preferably, the nasal prosthesis is cleaned and sterilized with ethylene oxide to ensure safety during surgical use.

[0046] In a third aspect, the present invention provides a method for preparing the nasal prosthesis according to the second aspect, the method comprising the following steps:

[0047] (1) inputting the image data obtained in step (1) into a medical three-dimensional modeling system to reconstruct a 3D model of the nose, importing the 3D model of the nose into a design software, performing segmented design of a nasal prosthesis, and obtaining nasal prosthesis model data;

[0048] (2) Using the prosthesis material as described in the first aspect and performing 3D printing according to the nasal prosthesis model data obtained in step (1), the nasal prosthesis is obtained.

[0049] The nasal prosthesis preparation method provided by the present invention realizes the precise matching of the prosthesis with the individual nasal anatomical features through the combination of personalized customization algorithm and software platform; for the complex anatomical structure of the nose, an advanced data processing algorithm and printing path planning strategy are developed to improve the design and manufacturing accuracy of the personalized prosthesis, reduce the customization difficulty, and ensure that each prosthesis can accurately match the individual characteristics of the patient. The equipment and material costs of the nasal prosthesis preparation method provided by the present invention are relatively low, which is conducive to medical beauty clinics to provide high-quality services while controlling costs.

[0050] Preferably, the image data is obtained by capturing images of the patient's nose.

[0051] Preferably, the image acquisition method includes CT scanning, magnetic resonance imaging or optical body surface scanning.

[0052] Preferably, the medical three-dimensional modeling system includes a CAD system and / or a CAM system.

[0053] Preferably, the design software includes Mimics and / or ViewSTL.

[0054] The method for preparing a nasal prosthesis provided by the present invention first imports the patient's nasal image acquisition data through a dedicated design software (such as a CAD / CAM system), and the doctor and the engineer collaborate to perform three-dimensional modeling, and make personalized adjustments according to the patient's facial features, aesthetic standards and personal wishes. The design software supports real-time simulation of the prosthesis implantation effect, including front, side, top and other perspectives, to ensure that the prosthesis is highly consistent with the patient's nasal anatomical structure. After the design is completed, an STL file is generated and directly input into a 3D printer for printing.

[0055] Preferably, the 3D printing comprises fused deposition modeling (FDM) printing.

[0056] As the preferred technical solution of the present invention, FDM printing technology is used to heat the prosthesis wire to a molten state, and the material is deposited layer by layer through the print head according to the designed three-dimensional model to accurately construct the complex geometric shape of the prosthesis. During the printing process, the printing parameters are adjusted to ensure that the wire melts evenly and the layers are firmly bonded, thereby achieving high-precision manufacturing. The FDM printer is easy to operate, and there is no chemical pollution or toxic gas generated during the printing process, which ensures the safety and health of the working environment.

[0057] Preferably, the nozzle temperature of the fused deposition modeling printing is 100-250°C, for example, 120°C, 150°C, 180°C, 200°C or 220°C.

[0058] Preferably, the print bed temperature of the fused deposition modeling printing is 50-100°C, for example, 55°C, 60°C, 70°C, 80°C or 90°C.

[0059] Preferably, the printing speed of the fused deposition modeling printing is 20-80 mm / s, for example, it can be 25 mm / s, 30 mm / s, 35 mm / s, 40 mm / s, 50 mm / s, 60 mm / s or 70 mm / s.

[0060] Preferably, the layer thickness of the fused deposition modeling printing is 0.01-1 mm, for example, it can be 0.05 mm, 0.08 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.5 mm or 0.8 mm.

[0061] The present invention optimizes the FDM printing process parameters to ensure stable molten deposition and precise forming of the composite material, avoids damage to the bioactive material caused by high-temperature printing, and achieves an effective balance between bioactivity and printing accuracy.

[0062] Exemplarily, the use of the obtained nasal prosthesis includes the following steps: a fine "W"-shaped incision is made at the narrowest part of the columella, followed by gradual separation of tissues in layers, revealing the lower lateral cartilage, nasal septum cartilage and the nasal spine in front in turn; then, a space for accommodating the nasal dorsum is opened under the periosteum, and the inverted "V"-shaped interface at the bottom of the "human"-shaped columella part is precisely connected to the nasal spine, and the entire bracket is firmly nested in the front and rear edges of the nasal septum and firmly fixed to the nasal septum; in addition, two thin sheets are configured and placed on both sides of the upper edge of the nasal septum, with the front end close to the columella and integrated with the nasal septum and lateral cartilage to ensure structural stability; at the same time, the height of the bilateral nasal domes is appropriately raised to ensure that the columella prosthesis is about 2.0 mm higher than the nasal dome plane; the belly groove of the nose tip part is tightly engaged with the protruding columella part on the dome plane, simulating the mortise and tenon joint principle to enhance stability. The nasal dorsum and nasal root prostheses are placed in the nasal dorsum cavity, adjusted to a suitable position, and sutured and fixed to the dorsal side of the nasal septum.

[0063] Compared with the prior art, the present invention has at least the following beneficial effects:

[0064] The present invention provides a prosthetic material, a nasal prosthesis containing the same, and a preparation method. By compounding a specific ratio of a degradable polymer material and an inorganic material, the necessary flexibility and plasticity of the prosthesis are maintained, while sufficient mechanical strength and ideal bone integration ability are provided. Combined with a personalized customization method, the prosthesis is accurately matched with the individual nasal anatomical characteristics, the design and manufacturing accuracy of the personalized prosthesis is improved, and the customization difficulty is reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1 This is the design drawing of the nasal prosthesis in Application Example 1;

[0066] Figure 2 This is the design diagram of the nasal prosthesis and nasal base in Application Example 1;

[0067] Figure 3 This is the nasal prosthesis slice file in Application Example 1;

[0068] Figure 4 This is a characterization diagram of the mechanical properties of the prosthesis material in Application Example 1;

[0069] Figure 5 This is a pathological section of the prosthetic material in Application Example 1. DETAILED DESCRIPTION

[0070] The technical solution of the present invention is further described below in conjunction with the accompanying drawings and through specific implementation methods. However, the following examples are only simplified examples of the present invention and do not represent or limit the scope of protection of the present invention. The scope of protection of the present invention shall be subject to the claims.

[0071] In the following specific embodiments of the present invention, the degradable polymer material is polycaprolactone (McLean, P871874), and other materials are commercially available products.

[0072] Example 1

[0073] A prosthetic material comprises, by weight, 50 parts of polycaprolactone and 50 parts of tricalcium phosphate.

[0074] Example 2

[0075] A prosthetic material comprises, by weight, 20 parts of polycaprolactone and 80 parts of hydroxyapatite.

[0076] Example 3

[0077] A prosthetic material comprises, by weight, 90 parts of polycaprolactone and 10 parts of tricalcium phosphate.

[0078] Comparative Example 1

[0079] A prosthetic material, using only a single PCL product, the material used is McLean, P871874.

[0080] Comparative Example 2

[0081] A prosthetic material that uses only a single TCP product, the material used is McLean, C796535.

[0082] Comparative Example 3

[0083] A prosthetic material comprises, by weight, 95 parts of polycaprolactone and 5 parts of tricalcium phosphate.

[0084] Comparative Example 4

[0085] A prosthetic material comprises, by weight, 15 parts of polycaprolactone and 85 parts of tricalcium phosphate.

[0086] Application Example 1

[0087] A nasal prosthesis, the nasal prosthesis is prepared by using the prosthesis material obtained in Example 1, the nasal prosthesis comprises a nasal root, a nasal dorsum, a nasal tip, a nasal columella and a nasal columella base, the nasal root is a single-layer structure in a fishbone shape, with a porosity of 80% and a thickness of 0.5 mm; the nasal dorsum part is designed as a double-layer structure in a plate shape, with a porosity of 80% for the outer layer and 50% for the inner layer, a thickness of 2 mm for the outer layer, and a thickness of 3 mm for the inner layer; the porosity of the nasal tip is 30% and a thickness of 2 mm; the nasal columella is composed of two thin sheets of 28×10×7 mm in size in a "human" shape, with a porosity of 30%; the porosity of the nasal columella base is 50% and a thickness of 1 mm;

[0088] The method for preparing the nasal prosthesis comprises the following steps:

[0089] (1) Collect the patient's nasal medical imaging data using CT scan data;

[0090] (2) The obtained image data was input into the Mimics system to reconstruct the 3D model of the nose, and the obtained 3D model of the nose was imported into ViewSTL for segmented design to obtain the nasal prosthesis model data, and then exported in .stl format;

[0091] (3) The nasal prosthesis model data obtained in step (2) is input into the fused deposition modeling (FDM) printing to implement precise printing, with the nozzle temperature of 130°C, the print bed temperature of 60°C, the printing speed of 50 mm / s, the layer thickness of 0.1 mm, and the printing error within 0.1 mm to obtain the nasal prosthesis.

[0092] Application Example 2

[0093] A nasal prosthesis is prepared by using the prosthesis material obtained in Example 2. The structure of the nasal prosthesis is the same as that of Application Example 1.

[0094] The method for preparing the nasal prosthesis comprises the following steps:

[0095] (1) Collect the patient's nasal medical imaging data using CT scan data;

[0096] (2) The obtained image data was input into the Mimics system to reconstruct the 3D model of the nose, and the obtained 3D model of the nose was imported into ViewSTL for segmented design to obtain the nasal prosthesis model data, and then exported in .stl format;

[0097] (3) The nasal prosthesis model data obtained in step (2) is input into the fused deposition modeling (FDM) printing to implement precise printing, with the nozzle temperature of 210°C, the print bed temperature of 80°C, the printing speed of 50 mm / s, the layer thickness of 0.1 mm, and the printing error within 0.1 mm to obtain the nasal prosthesis.

[0098] Application Example 3, Comparative Application Examples 1-4

[0099] A nasal prosthesis is different from Application Example 1 only in that it is prepared using the prosthesis materials obtained in Example 3 and Comparative Examples 1-4. The structure and preparation method of the nasal prosthesis are the same as those of Application Example 1.

[0100] Application Example 4

[0101] A nasal prosthesis, which differs from Application Example 1 only in that the root of the nose is designed as a single-layer structure in a fishbone shape, with a porosity of 60% and a thickness of 0.5mm; the nasal dorsum is designed as a double-layer structure in a plate shape, with the porosity of the outer layer set to 40% and the inner layer to 30%, the outer layer thickness is 2mm, and the inner layer thickness is 3mm; the nose tip has a porosity of 50% and a thickness of 2mm; the columella is composed of two thin sheets of 28×10×7mm in size in the shape of a "human" character, with a porosity of 30%; the columella base has a porosity of 30% and a thickness of 1mm; the preparation materials and preparation methods of the nasal prosthesis are the same as those in Application Example 1.

[0102] The nasal prosthesis obtained in the above application example was tested as follows:

[0103] (1) Pathological sections

[0104] ① Specimen preparation

[0105] 1.5% sodium pentobarbital was used to extract the material at 30 mg / kg -1 The rabbits were anesthetized by ear vein and fixed in supine position. The left hind limb knee joint of the rabbits was uniformly operated on, the surgical area was shaved, routinely disinfected, and covered with a towel. A longitudinal incision of about 3 cm was made on the inner side of the knee joint, the prosthesis implant was placed, and the incision was sutured.

[0106] ②Specimen fixation

[0107] Seven days after the incision was sutured, tissue specimens of the left hind limb knee joint of the rabbit were obtained and fixed in 4% paraformaldehyde for later hard tissue section analysis.

[0108] ③Specimen dehydration

[0109] The experimental starting gradient was 70% ethanol, and the specimens were immersed for 24 hours; the concentration of ethanol was increased by 5% for 24 hours until the concentration of ethanol reached 100%.

[0110] ④ The specimen is transparent

[0111] Use pure xylene for clearing, and the total time should not exceed 4 hours.

[0112] ⑤Methyl methacrylate monomer preparation

[0113] Configuration of Monomer III: The preparation of pure Monomer III is carried out according to the contents specified in Table 1 below.

[0114] Table 1

[0115]

[0116] Monomer II is the monomer liquid recovered after the specimen is immersed in pure monomer III.

[0117] Monomer I is the monomer liquid recovered after the specimen is soaked in the monomer II liquid.

[0118] ⑥Filtration and embedding

[0119] Filter and embed the specimens in the following order:

[0120] a. Place the transparent specimen into the monomer I solution and soak for 18 hours;

[0121] b. After pouring out monomer I, put into monomer II solution and soak for 24 hours;

[0122] c. After pouring out monomer II, put into monomer III solution and soak for 24 hours;

[0123] d. Replace the new vacuum container and set the suction intensity to 2×10 4 Pa, vacuuming time is about 4 hours to ensure that the gas in the bone tissue is completely discharged; cover the bottle cap and reserve a ventilation hole on the bottle cap, place it in the monomer III solution that has been standing in a refrigerator at 4°C for 5 days, and add a small amount of pure monomer hardening block to the embedding container; place it in a negative pressure environment for 24 hours. Then place it at room temperature to continue polymerization until solidification;

[0124] e. In the later stage of curing, place it in a 40℃ oven until it is completely hardened; when a Kirschner wire is used to poke the surface, if it is completely hardened and there are no bubbles around the specimen in the cured block, it indicates that the embedding is successful.

[0125] ⑦ Slicing and grinding

[0126] After the embedded glass container was smashed, the embedded block was trimmed and fixed firmly on the slicer (EXAKT310, EXAKT, Germany), and the cutting direction of the blade was parallel to the long axis of the bone defect, that is, cutting along the coronal plane. After ultrasonic cleaning of the slices for 10 seconds, they were rinsed with double distilled water for 2 minutes, dried at room temperature, and then glued to the organic glass slides for hard tissues with adhesive (to avoid bubbles). After gluing, the slices were ground and polished, and the slice thickness was 60 μm.

[0127] ⑧H&E dyeing:

[0128] a. Spread and mount: Turn on the water bath, adjust the water temperature to 40°C, and prepare a 30% ethanol solution. First, place the tissue slice in the 30% ethanol solution to spread it out. Then place the tissue slice in the water bath to fully spread it out. Take a clean slide and place the tissue slice on it.

[0129] b. Dewaxing and rehydration: Adjust the temperature of the water bath to 60°C. Then place the slices in a water bath for 30 minutes to melt the paraffin. Then soak them in xylene solution I for 30 minutes, and then soak them in xylene solution II for 30 minutes to fully wash out the paraffin. Then soak the sample slices in 100%, 95%, 85%, and 70% ethanol solutions for 5 minutes to rehydrate. Then soak the tissue slices in distilled water for 5 minutes.

[0130] c. Staining: Use hematoxylin staining solution to stain the tissue sections for 10 minutes, then rinse with running water for 15 minutes, and then dehydrate the stained sections in an ethanol solution for 5 minutes (50%, 70% and 80%); use eosin staining solution to stain for 10 minutes, then rinse with running water for 15 minutes, and then dehydrate the stained sections in a 95% ethanol solution for 5 minutes.

[0131] d. Seal the slide: Soak the slide in xylene solution twice, 5 minutes each time. Then seal the slide with neutral resin. Neutral resin can be diluted to an appropriate concentration with xylene.

[0132] e. Observation: The stained sections can be observed and photographed under an optical microscope.

[0133] Test results such as Figure 5 As shown, the red color in the figure is the new bone, and the black color is the material, which proves that the prosthetic material obtained by compounding the degradable polymer material with the inorganic material in the present invention has the ability of bone integration.

[0134] (2) Tensile test

[0135] The tensile properties are tested according to the GB / T 1041-2008 standard.

[0136] The test results are summarized in Table 2.

[0137] Table 2

[0138]

[0139] Through Table 2 and Figure 4 It can be seen from the test results that the present invention obtains prosthetic materials by compounding degradable polymer materials with inorganic materials, thereby improving the flexibility and ductility of the prosthesis and providing sufficient mechanical strength. When it is used in the preparation of nasal prostheses, combined with a specific preparation method, efficient, rapid, high-precision and personalized prosthesis customization can be achieved.

[0140] By comparing Application Example 1 with Comparative Application Examples 1-4, it can be seen that the present invention obtains a prosthetic material with better mechanical strength and ductility by compounding tricalcium phosphate and polycaprolactone, and further improves the application performance of the material by optimizing the ratio of the two.

[0141] By comparing Application Example 1 with Application Example 4, it can be seen that the present invention can better improve the flexibility and ductility of the prosthesis and improve the mechanical strength of the prosthesis by adjusting the porosity of the prosthesis.

[0142] The applicant declares that the above is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention shall fall within the protection scope and disclosure scope of the present invention.

Claims

1. A prosthetic material, characterized in that: In parts by weight, the prosthetic material comprises 20-90 parts of degradable polymer material and 10-80 parts of inorganic material; The degradable polymer material includes any one of polycaprolactone, polylactic acid, polyurethane or polyetheretherketone, or a combination of at least two thereof; The inorganic material includes tricalcium phosphate and / or hydroxyapatite.

2. The prosthetic material according to claim 1, characterized in that The degradable polymer material includes polycaprolactone, and the inorganic material includes tricalcium phosphate; Preferably, the weight average molecular weight of the degradable polymer material is 60000-100000 g / mol; Preferably, the particle size of the inorganic material is 0.5-5 μm.

3. A nasal prosthesis, characterized in that: The nasal prosthesis is prepared from the prosthesis material according to claim 1 or 2.

4. The nasal prosthesis according to claim 3, characterized in that: The interior of the nasal prosthesis is a porous structure; Preferably, the surface of the nasal prosthesis has a rough texture.

5. The nasal prosthesis according to claim 3 or 4, characterized in that: The nasal prosthesis includes a nasal root, a nasal dorsum, a nasal tip, a columella and a columella base.

6. The nasal prosthesis according to claim 5, characterized in that: The shape of the nasal root includes semi-elliptical, fishbone or fishtail; Preferably, the porosity of the nasal root is 50-90%; Preferably, the thickness of the nasion is 0.3-1 mm; Preferably, the shape of the nose dorsum includes any one of willow-leaf shape, fishtail shape, plate shape, I shape, L shape or T shape; Preferably, the nose dorsum is a double-layer structure; Preferably, the porosity of the nose dorsum is 10-90%; Preferably, the thickness of each layer of the nasal dorsum is independently 1-5 mm; Preferably, the nose tip is a hollow T-shaped structure; Preferably, the outer portion of the nose tip is spherical; Preferably, the porosity of the nose tip is 20-90%; Preferably, the thickness of the nose tip is 1-3 mm.

7. The nasal prosthesis according to claim 5 or 6, characterized in that: The columella is a mesh structure; Preferably, the porosity of the columella is 10-90%; Preferably, the thickness of the columella is 0.1-10 mm; Preferably, the columella base is in sheet shape; Preferably, the porosity of the columella base is 10-90%; Preferably, the thickness of the columella base is 1-3 mm.

8. A method for preparing a nasal prosthesis according to claims 3-7, characterized in that: The preparation method comprises the following steps: (1) inputting the image data into a medical three-dimensional modeling system, reconstructing a 3D model of the nose, importing the 3D model of the nose into a design software, performing segmented design of a nasal prosthesis, and obtaining nasal prosthesis model data; (2) Using the prosthetic material as described in claim 1 or 2 and performing 3D printing according to the nasal prosthesis model data obtained in step (1), the nasal prosthesis is obtained.

9. The preparation method according to claim 8, characterized in that: The image data is obtained by collecting images of the patient's nose; Preferably, the image acquisition method includes CT scanning, magnetic resonance imaging or optical body surface scanning; Preferably, the medical three-dimensional modeling system includes a CAD system and / or a CAM system; Preferably, the design software includes Mimics and / or ViewSTL.

10. The preparation method according to claim 8 or 9, characterized in that: The 3D printing includes fused deposition modeling printing; Preferably, the nozzle temperature of the fused deposition modeling printing is 100-250°C; Preferably, the print bed temperature of the fused deposition modeling printing is 50-100°C; Preferably, the printing speed of the fused deposition modeling printing is 20-80 mm / s; Preferably, the layer thickness of the fused deposition modeling printing is 0.01-1 mm.

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