Tantalum metal porous cone pile loaded with bisphosphonate and preparation method thereof

Abstract

The present invention provides a tantalum metal porous cone pile loaded with bisphosphonate and a preparation method thereof, which relates to the technical field of medical devices, including a cone pile, which is made of tantalum metal using 3D printing technology, and has a conical structure. The cone pile includes a cone bottom, a cone body and a cone layer, and the surface of the cone pile is sprayed with bisphosphonate. The structural design of the cone pile of the present invention can make the bone structure foundation more stable, and the cone structure effectively disperses the mechanical load borne by the bone. The unique embedded structure design enhances the integration performance between the cone pile and the bone, so that the loosening rate of the prosthesis can be effectively reduced, the stability can be improved, and the service life can be increased. The surface is sprayed with bisphosphonate to make it have an anti-osteoporosis effect.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a tantalum metal porous cone pile loaded with bisphosphonate and a preparation method thereof. Background Art

[0002] Nowadays, the number of joint replacement surgeries is increasing, and the difficulties encountered during the surgery are becoming more and more diverse. Among them, elderly patients have varying degrees of osteoporosis during joint replacement surgery. The patients' bone density is reduced, and the bone strength is weakened, which will have a certain degree of impact on the stability and fixation of joint prosthesis implants, increasing the risk of prosthesis loosening or displacement;

[0003] Clinically, there are many ways to improve the stability and function of prostheses for osteoporotic patients, such as using femoral condyle and tibial plateau prostheses with extended stems to improve stability. However, this will increase stress shielding of local bone and aggravate osteoporosis. Since the use of femoral condyle restrictive prostheses will also cause stress concentration and reduce the service life of the prosthesis, it is not suitable for improving the basic bone structure and it is difficult to obtain satisfactory results.

[0004] Therefore, there is currently a lack of an implant that can improve the stability of bone prostheses for osteoporosis patients, prolong the lifespan, and resist osteoporosis. Summary of the invention

[0005] The present invention provides a tantalum metal porous cone pile loaded with bisphosphonate and a preparation method thereof, which are used to solve at least one of the technical problems mentioned above.

[0006] In order to solve the above technical problems, the present invention discloses a tantalum metal porous cone pile loaded with bisphosphonate, including a cone pile. The cone pile is made of tantalum metal using 3D printing technology. The cone pile is a cone structure. The cone pile includes a cone bottom, a cone body and a cone layer. The surface of the cone pile is sprayed with bisphosphonate.

[0007] Preferably, the tapered pile has a taper of 0.25-0.5;

[0008] The cone bottom diameter is 5-10 mm;

[0009] The cone height is 20-30mm;

[0010] The cone layer is a trumpet-shaped barbed structure opening downward, and there is a gap of 0.5 mm between adjacent cone layers.

[0011] Preferably, the cone pile is a porous structure, and the interior of the cone pile has a pore structure with a pore size of 200 μm-500 μm and a porosity of 50%-80%.

[0012] Preferably, the elastic modulus of the tapered pile is between 10 GPa and 60 GPa.

[0013] Preferably, the cone pile is sprayed with hydroxyapatite to load the bisphosphonate onto the surface of the cone pile to form a uniform drug coating;

[0014] The dosage of sprayed bisphosphonate drugs is 1mg / cm³-5mg / cm³.

[0015] A method for preparing a tantalum metal porous cone pile loaded with bisphosphonate, comprising the following steps:

[0016] S1. Prepare raw materials, including tantalum metal powder, bisphosphonate and hydroxyapatite mixed solution;

[0017] S2. Setting the printing parameters of the 3D printing device, and using tantalum metal powder to melt and deposit layer by layer according to the design drawings to construct a tantalum metal cone pile with a conical structure;

[0018] S3, placing the printed cone pile in a high temperature furnace for heat treatment to eliminate the residual stress in the printing process and improve the mechanical properties of the cone pile;

[0019] S4, preparing a bisphosphonate drug coating, using a spraying device to evenly spray a mixed solution of phosphonate and hydroxyapatite on the surface of the cone pile to form a drug coating layer, and then drying it naturally;

[0020] S5. Conduct quality assessment on the prepared cone piles, and package and sterilize them after they pass the quality assessment.

[0021] Preferably, the packaging sterilization adopts gamma ray or ethylene oxide sterilization to sterilize the cone pile to ensure the sterile state.

[0022] Preferably, step S5 comprises:

[0023] S51, placing the prepared cone pile on a rotating table, dividing the cone pile into n acquisition areas, performing several image acquisitions on each acquisition area of ​​the cone pile, obtaining several quality inspection acquisition images of each acquisition area, and obtaining a surface unevenness coefficient of the corresponding acquisition area based on the several quality inspection acquisition images of each acquisition area;

[0024] S52, measuring the internal porosity corresponding to n collection areas of the cone pile by micro-CT scanning;

[0025] S53, using an ultrasonic detector to measure the elastic modulus corresponding to n collection areas of the cone pile;

[0026] S54, using a 3D scanner to obtain the size parameters of the cone pile;

[0027] S55. Based on the surface unevenness coefficient, internal porosity, elastic modulus, several dimensional parameters corresponding to the n collection areas and the reference surface unevenness coefficient range, reference internal porosity range, reference elastic modulus range and several reference dimensional parameter ranges of the tapered piles, determine whether the corresponding tapered piles are qualified; if any one of them is unqualified, the tapered pile will be eliminated; if all are qualified, calculate the quality grade of the corresponding tapered piles, and grade the tapered piles based on the size specifications and quality grades of the corresponding tapered piles.

[0028] Preferably, step S51 includes:

[0029] S511, inputting a plurality of quality inspection collection images of each collection area into the trained cone pile surface uneven area recognition model, identifying a plurality of surface uneven areas of each quality inspection collection image, and obtaining a plurality of surface uneven area images of each quality inspection collection image;

[0030] S512, obtaining the pixel value of each pixel point of each surface unevenness area image of each quality inspection acquisition image, and calculating the pixel mean value of the adjacent pixels of each pixel point of each surface unevenness area image, and using it as the assisting pixel of the corresponding pixel point of the corresponding surface unevenness area image of the corresponding quality inspection acquisition image;

[0031] S513, taking the quotient of the sum of the assisting pixels at the same pixel position of each quality inspection acquisition image and the total number of quality inspection acquisition images acquired in the corresponding acquisition area as the reference pixel at each pixel position, and taking the image composed of all the reference pixels as the discrimination image;

[0032] S514, taking the quality inspection acquisition image with the highest pixel among all the quality inspection acquisition images acquired in the same acquisition area as the comparison image, calculating the absolute value of the pixel value of the reference pixel at each pixel point position of the discrimination image and the corresponding pixel point position of the comparison image, when the absolute value of the pixel value of the reference pixel at each pixel point position of the discrimination image and the corresponding pixel point position of the comparison image is greater than the preset pixel difference, marking the corresponding pixel point position as an uneven position, and taking the quotient of the absolute value of the pixel value of the reference pixel at each pixel point position of the discrimination image and the corresponding pixel point position of the comparison image and the preset pixel difference as the uneven degree coefficient of the corresponding uneven position;

[0033] S515: The sum of the unevenness coefficients of all uneven positions on the contrast image of each acquisition area is taken as the surface unevenness coefficient of the corresponding acquisition area.

[0034] Preferably, the quality grade of the cone pile is calculated:

[0035] ;in, is the quality grade of the cone pile, is the logarithm to base e, is the weight of the surface unevenness coefficient, is the surface unevenness coefficient of the jth acquisition area, is the maximum value of the reference surface unevenness coefficient of the jth acquisition area, is the minimum value of the reference surface unevenness coefficient of the jth acquisition area, is the weight of internal porosity, is the internal porosity of the jth collection area, is the maximum value of the reference internal porosity of the jth acquisition area, is the minimum value of the reference internal porosity of the jth acquisition area, is the weight of the elastic modulus, is the elastic modulus of the jth acquisition area, is the maximum value of the reference elastic modulus of the jth acquisition area, is the minimum value of the reference elastic modulus of the jth acquisition area, is the weight of the size parameter, is the value of the i-th size parameter, is the maximum value of the i-th size parameter, is the minimum value of the i-th dimension parameter, which includes the taper, cone bottom diameter, cone height and cone layer gap of the cone pile. The symbol for rounding up.

[0036] Compared with the prior art, the present invention has the following beneficial effects:

[0037] The structural design of the cone post of the present invention can make the bone structure foundation more stable. At the same time, the cone structure effectively disperses the mechanical load borne by the bone. The unique embedded structure design enhances the integration performance between the cone post and the bone, thereby effectively reducing the loosening rate of the prosthesis, improving stability, and increasing service life. The surface is sprayed with bisphosphonate to make it have an anti-osteoporosis effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention and do not constitute a limitation of the present invention. In the accompanying drawings:

[0039] Figure 1 This is a front view of a tantalum metal porous cone pile loaded with bisphosphonate according to the present invention.

[0040] Figure 2 This is a top view of a tantalum metal porous cone pile loaded with bisphosphonate according to the present invention.

[0041] In the figure: 1. Cone pile. DETAILED DESCRIPTION

[0042] The preferred embodiments of the present invention are described below in conjunction with the accompanying drawings. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0043] In addition, in the present invention, the descriptions of "first", "second", etc. are only used for descriptive purposes, and do not specifically refer to the order or sequence, nor are they used to limit the present invention. They are only used to distinguish components or operations described with the same technical terms, and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the technical solutions and technical features between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in the field to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0044] The present invention provides the following embodiments

[0045] Example 1

[0046] The embodiment of the present invention provides a tantalum metal porous cone pile loaded with bisphosphonate, such as Figure 1 and Figure 2 As shown, it includes a cone pile 1, which is made of tantalum metal using 3D printing technology. The cone pile 1 is a cone structure. The cone pile 1 includes a cone bottom, a cone body and a cone layer. The surface of the cone pile 1 is treated with bisphosphonate spraying.

[0047] Among them, bisphosphonates are white powders with strong affinity to hydroxyapatite, and play an anti-osteoporosis role by inhibiting osteoclast activity.

[0048] Preferably, the cone pile 1 has a taper of 0.25-0.5;

[0049] The cone bottom diameter is 5-10 mm;

[0050] The cone height is 20-30mm;

[0051] The cone layer is a trumpet-shaped barbed structure with an opening downward, and there is a 0.5mm gap between adjacent cone layers. (During implantation, bone tissue can be embedded in the pores of cone post 1 to promote the combination of bone and cone post 1)

[0052] The working principle and beneficial effects of the above technical solution are as follows: the structural design of the cone pile 1 of the present invention can make the bone structure foundation more stable, and the conical structure effectively disperses the mechanical load borne by the bone. The unique embedded structure design enhances the integration performance between the cone pile 1 and the bone, thereby effectively reducing the loosening rate of the prosthesis, improving stability, and increasing service life. The surface is sprayed with bisphosphonate to make it have an anti-osteoporosis effect.

[0053] The advantages of tantalum metal porous cone posts loaded with bisphosphonates in prosthetic replacement are specifically manifested in the following aspects:

[0054] (1) The filling implant of the cone post 1 increases the contact area between the cone post 1 and the bone tissue, provides higher initial stability during implantation through radial compression force, reduces the risk of prosthesis loosening, and can immediately improve the mechanical properties of the bone foundation;

[0055] (2) The porous structure of cone pile 1 is closer to the elastic modulus of human bones, avoiding stress shielding and stress concentration, avoiding the stress shielding effect caused by hardness differences, ensuring the biomechanical adaptability of the prosthesis, facilitating bone cell attachment and bone tissue ingrowth, and promoting bone integration.

[0056] (3) The cone-cone structure design can disperse stress, enhance stability, avoid local stress overload, extend the service life of the prosthesis, reduce the need for secondary revision surgery, and improve the long-term treatment effect of patients;

[0057] (4) The unique embedded structure and material properties can form a tight bond in the bone, making the cone post 1 a part of the bone, promoting bone integration and reducing the loosening rate;

[0058] (5) The anti-osteoporosis drug (bisphosphonate) on the surface of cone pile 1 has a sustained release effect, exerting an anti-osteoporosis effect locally.

[0059] The present cone pile 1 not only simplifies the surgical process and reduces the difficulty of operation, but also significantly improves the bearing capacity of the bone after surgery. More importantly, it enhances the immediate and medium- and long-term biomechanical stability between the prosthesis and the bone interface, thereby effectively reducing the risk of prosthesis failure and providing patients with a more reliable and lasting treatment effect.

[0060] The specific usage is as follows:

[0061] Preoperative preparation: Before the operation, the doctor needs to conduct a comprehensive imaging examination (such as X-ray, CT or MRI) and bone density measurement to understand the patient's osteoporosis condition and select the appropriate model of the spare cone pile 1 according to the imaging data to achieve the expected effect;

[0062] Intraoperative positioning and implantation: The cone post 1 is used in bone cement artificial joint replacement surgery and is implanted into the bone tissue through open surgery. The specific steps are as follows:

[0063] ① Fully expose the bone bed where the artificial joint prosthesis is to be implanted. After pulse flushing, the surgeon will make a final decision on whether to implant the artificial joint prosthesis based on the local bone quality, the location, model and number of the implanted cone pile 1, and make sure the model of the cone pile 1 matches the depth of the reinforced part;

[0064] ② Positioning the cone pile: Drive the cone pile 1 into the osteoporotic bone and ensure that its conical slope is in close contact with the bone to achieve a stabilizing effect. The conical structure enables the cone pile 1 to generate radial compression force during implantation, thereby improving the stability of the initial implantation;

[0065] Fixation and reinforcement: The biomechanical properties of the cone post 1 design can be stably combined with the bone during implantation, but to further ensure its stable position, the following methods are usually adopted:

[0066] ① Light hammering: The cone pile 1 is gradually driven into the bone by light hammering. This process enables the embedded structure of the cone pile 1 to be in close contact with the surrounding bone tissue;

[0067] ② Filling with bone grafts: Fill the gap between the cone post 1 and the surrounding bone with autologous or allogeneic bone grafts to promote bone integration. Especially for patients with severe bone defects or osteoporosis, bone grafts can provide better mechanical support and growth matrix;

[0068] Drug release mechanism

[0069] After the cone post 1 is implanted, the bisphosphonate drug on the surface of the cone post 1 begins to be released to enhance bone density and inhibit bone loss. After implantation, the bisphosphonate can be continuously released locally, inhibiting the activity of osteoclasts by binding to calcium, thereby slowing down the progression of osteoporosis. Since the drug is evenly distributed on the surface of the cone post 1 through spraying technology, the release rate of the drug is relatively uniform, and it can continuously provide anti-osteoporosis effects for a long time after surgery, reducing the long-term impact of osteoporosis on the stability of the prosthesis;

[0070] Biomechanical stability testing and validation

[0071] During the operation, the biomechanical stability of cone pile 1 needs to be checked to ensure that the cone pile 1 is in the correct position and has sufficient initial stability, including:

[0072] Manual test: After implanting the cone post 1, the doctor performs a rotation and push test to ensure that the cone post 1 does not loosen or move;

[0073] Radiographic confirmation: Confirm through intraoperative fluoroscopy whether the cone post 1 is completely implanted in the predetermined position, ensure that the cone bottom is in close contact with the bone surface, and the gap between the cone layers is in full contact with the bone tissue, laying the foundation for postoperative bone integration.

[0074] Example 2

[0075] On the basis of Example 1, the cone pile 1 is a porous structure, and the inside of the cone pile 1 has a pore structure with a pore size of 200 μm-500 μm and a porosity of 50%-80%.

[0076] Preferably, the elastic modulus of the tapered pile 1 is between 10 GPa and 60 GPa.

[0077] Preferably, the cone pile 1 is sprayed with hydroxyapatite to load the bisphosphonate onto the surface of the cone pile 1 to form a uniform drug coating;

[0078] The dosage of sprayed bisphosphonate drugs is 1mg / cm³-5mg / cm³.

[0079] The working principle and beneficial effects of the above technical solution are as follows: the bisphosphonate drug dosage is 1mg / cm³-5mg / cm³, which is evenly loaded on the surface of the cone post 1 through spraying technology to form a drug coating to achieve anti-osteoporosis effect. The interior of the cone post 1 has a pore structure with a pore size of 200μm-500μm and a porosity of 50%-80%, which can provide a good environment for bone cell penetration and new bone growth. The conical body and porous tantalum metal structure of the cone post 1 are designed according to the mechanical requirements of the bone tissue of osteoporosis patients to facilitate stable implantation and enhance the stability of the prosthesis in joint replacement. The tantalum metal cone post has a low elastic modulus (10 GPa-60 GPa), which is effectively close to the mechanical properties of human bone and reduces stress shielding. The horn-shaped barb-like structure, rough surface and drug-loaded porous tantalum mesh structure of the porous tantalum metal cone post are conducive to bone integration and improve the biomechanical stability of the prosthesis.

[0080] Example 3

[0081] Based on Example 1, a method for preparing a tantalum metal porous cone pile loaded with bisphosphonate comprises the following steps:

[0082] S1. Prepare raw materials, including tantalum metal powder, bisphosphonate and hydroxyapatite mixed solution;

[0083] S2, setting the printing parameters of the 3D printing device, and using tantalum metal powder to melt and deposit layer by layer according to the design drawings to construct a tantalum metal cone pile 1 with a conical structure;

[0084] S3, placing the printed cone pile 1 into a high temperature furnace for heat treatment to eliminate residual stress in the printing process and improve the mechanical properties of the cone pile 1;

[0085] S4, preparing a bisphosphonate drug coating, using a spraying device to evenly spray a mixed solution of phosphonate and hydroxyapatite on the surface of the cone pile 1 to form a drug coating layer, and then naturally drying;

[0086] S5. Evaluate the quality of the prepared cone pile 1, and package and sterilize it after it passes the quality evaluation.

[0087] Preferably, the packaging sterilization adopts gamma ray or ethylene oxide sterilization to sterilize the cone pile 1 to ensure a sterile state.

[0088] Preferably, in the preparation of raw materials, tantalum metal powder: high-purity tantalum metal powder is selected as the basic material for preparing the cone pile 1;

[0089] Bisphosphonate solution: prepare off-white powdered bisphosphonate and dissolve it in an appropriate amount of solvent. The concentration should be within the range of 1mg / cm³-5mg / cm³.

[0090] Hydroxyapatite: used to assist the spraying of bisphosphonates and improve the adhesion of the drug coating;

[0091] Solvent: Choose a solvent suitable for the spraying process, such as ethanol.

[0092] Preferably, step S2 specifically includes: 3D printing equipment preparation: selecting a suitable 3D printing equipment, such as a laser selective melting (SLM) equipment or an electron beam selective melting (EBSM) equipment;

[0093] Printing parameter setting: Set the printing parameters, including laser power, scanning speed, powder thickness, porosity and pore size. For example, the laser power is 200W, the scanning speed is 1000mm / s, the powder thickness is 50μm, the porosity is 70%, and the pore size is 300μm.

[0094] Preferably, the heat treatment parameters in step S3 include heating to 1000° C. and keeping the temperature for 2 hours.

[0095] Preferably, the spraying equipment is such as a compressed air spray gun or an ultrasonic spraying equipment;

[0096] The spraying parameters included spraying pressure: 0.5 MPa, spraying distance: 10 cm, and spraying time: 30 seconds.

[0097] Preferably, the packaging sterilization adopts gamma ray or ethylene oxide sterilization to sterilize the cone pile 1 to ensure a sterile state.

[0098] The working principle and beneficial effects of the above technical solution are as follows: first, raw materials including tantalum metal powder, bisphosphonate solution and hydroxyapatite mixed solution are prepared; then, tantalum metal powder is melted and deposited layer by layer according to the design drawings through 3D printing equipment to construct a tantalum metal cone pile with a conical structure; then, the printed cone pile 1 is placed in a high-temperature furnace for heat treatment to eliminate residual stress in the printing process and improve the mechanical properties of the cone pile 1; next, the phosphonate and hydroxyapatite mixed solution is evenly sprayed on the surface of the cone pile 1 through a spraying device to form a layer of drug coating, which is then naturally dried; finally, the prepared cone pile 1 is quality evaluated and sterilized by gamma ray or ethylene oxide sterilization. This preparation method can ensure that the structure and performance of the cone pile 1 meet clinical needs, ensure its stability and effectiveness during surgery, and thus improve the success rate of prosthetic replacement surgery.

[0099] Example 4

[0100] Based on Example 3, step S5 includes:

[0101] S51, placing the prepared cone pile 1 on a rotating table, dividing the cone pile 1 into n acquisition areas, performing several image acquisitions on each acquisition area of ​​the cone pile 1, obtaining several quality inspection acquisition images of each acquisition area, and obtaining the surface unevenness coefficient of the corresponding acquisition area based on the several quality inspection acquisition images of each acquisition area;

[0102] S52, measuring the internal porosity corresponding to 1n collection areas of the cone pile by micro-CT scanning;

[0103] S53, using an ultrasonic detector to measure the elastic modulus corresponding to 1n collection areas of the cone pile;

[0104] S54, using a 3D scanner to obtain the size parameters of the cone pile 1;

[0105] S55. Based on the surface unevenness coefficient, internal porosity, elastic modulus, several dimensional parameters corresponding to the n collection areas and the benchmark surface unevenness coefficient range, benchmark internal porosity range, benchmark elastic modulus range and several benchmark dimensional parameter ranges of the cone pile 1, determine whether the corresponding cone pile 1 is qualified; if any one of them is unqualified, the cone pile 1 is discarded; if all are qualified, calculate the quality grade of the corresponding cone pile 1, and grade the cone pile 1 based on the size specification and quality grade of the corresponding cone pile 1.

[0106] The working principle and beneficial effects of the above technical solution are as follows: first, the cone pile 1 is placed on a rotating table and divided into a plurality of collection areas. Multiple image collections are performed on each collection area to obtain a number of quality inspection images of each area. Then, the internal porosity of each area is measured by micro-CT scanning, the elastic modulus of each area is measured by an ultrasonic detector, and the size parameters of the cone pile 1 are obtained by a 3D scanner. Finally, based on these parameters and the corresponding reference range, it is determined whether the cone pile 1 is qualified.

[0107] If any parameter fails to meet the requirements, the cone post 1 will be discarded; if all parameters meet the requirements, the quality grade of the cone post 1 will be calculated and graded. This method can ensure the consistency of quality and performance of each cone post 1, improve the consistency and reliability of the product, and thus enhance the effect of prosthetic replacement surgery.

[0108] Example 5

[0109] Based on Example 4, step S51 includes:

[0110] S511, inputting a plurality of quality inspection collection images of each collection area into the trained cone pile surface uneven area recognition model, identifying a plurality of surface uneven areas of each quality inspection collection image, and obtaining a plurality of surface uneven area images of each quality inspection collection image;

[0111] S512, obtaining the pixel value of each pixel point of each surface unevenness area image of each quality inspection acquisition image, and calculating the pixel mean value of the adjacent pixels of each pixel point of each surface unevenness area image, and using it as the assisting pixel of the corresponding pixel point of the corresponding surface unevenness area image of the corresponding quality inspection acquisition image;

[0112] S513, taking the quotient of the sum of the assisting pixels at the same pixel position of each quality inspection acquisition image and the total number of quality inspection acquisition images acquired in the corresponding acquisition area as the reference pixel at each pixel position, and taking the image composed of all the reference pixels as the discrimination image;

[0113] S514, taking the quality inspection acquisition image with the highest pixel among all the quality inspection acquisition images acquired in the same acquisition area as the comparison image, calculating the absolute value of the pixel value of the reference pixel at each pixel point position of the discrimination image and the corresponding pixel point position of the comparison image, when the absolute value of the pixel value of the reference pixel at each pixel point position of the discrimination image and the corresponding pixel point position of the comparison image is greater than the preset pixel difference, marking the corresponding pixel point position as an uneven position, and taking the quotient of the absolute value of the pixel value of the reference pixel at each pixel point position of the discrimination image and the corresponding pixel point position of the comparison image and the preset pixel difference as the uneven degree coefficient of the corresponding uneven position;

[0114] S515: The sum of the unevenness coefficients of all uneven positions on the contrast image of each acquisition area is taken as the surface unevenness coefficient of the corresponding acquisition area.

[0115] The working principle and beneficial effects of the above technical solution are as follows: first, the quality inspection image of each acquisition area is input into a trained cone pile surface uneven area recognition model to identify the surface uneven area in each image, and then a discrimination image is generated by calculating the pixel mean of the adjacent pixels of each pixel, and then, the reference pixel in the discrimination image is compared with the pixel value in the comparison image to calculate the unevenness coefficient of each uneven position, and finally, the sum of the unevenness coefficients of all uneven positions on the comparison image of each acquisition area is taken as the surface unevenness coefficient of the corresponding acquisition area. The surface unevenness of the cone pile 1 is reflected by the surface unevenness coefficient of the corresponding acquisition area. This method can accurately evaluate the unevenness of the surface of the cone pile 1.

[0116] Example 6

[0117] Based on Example 4, the quality grade of the cone pile 1 is calculated:

[0118] (1); among which, is the quality grade of cone pile 1, is the logarithm to base e, is the weight of the surface unevenness coefficient, is the surface unevenness coefficient of the jth acquisition area, is the maximum value of the reference surface unevenness coefficient of the jth acquisition area, is the minimum value of the reference surface unevenness coefficient of the jth acquisition area, is the weight of internal porosity, is the internal porosity of the jth collection area, is the maximum value of the reference internal porosity of the jth acquisition area, is the minimum value of the reference internal porosity of the jth acquisition area, is the weight of the elastic modulus, is the elastic modulus of the jth acquisition area, is the maximum value of the reference elastic modulus of the jth acquisition area, is the minimum value of the reference elastic modulus of the jth acquisition area, is the weight of the size parameter, is the value of the i-th size parameter, is the maximum value of the i-th size parameter, is the minimum value of the i-th dimension parameter, and the dimension parameters include the taper, cone bottom diameter, cone height and cone layer gap of cone pile 1. The round-up symbol.

[0119] The working principle and beneficial effects of the above technical solution are as follows: Formula (1) comprehensively considers multiple factors such as surface unevenness coefficient, internal porosity, elastic modulus and size parameters. By calculating the collection parameters of each collection area and comparing them with the reference range, the quality score of each area can be obtained, thereby obtaining the quality grade of the entire cone pile 1. The lower the quality grade number, the better the quality. This method can comprehensively evaluate the various performance indicators of the cone pile 1 to ensure that its quality and stability meet clinical requirements.

[0120] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A method for preparing a tantalum metal porous cone pile loaded with bisphosphonate, characterized in that: The following steps are involved: S1. Prepare raw materials, including tantalum metal powder, bisphosphonate and hydroxyapatite mixed solution; S2, setting the printing parameters of the 3D printing device, and using tantalum metal powder to melt and deposit layer by layer according to the design drawing to construct a tantalum metal cone pile (1) with a conical structure; S3, placing the printed cone pile (1) in a high temperature furnace for heat treatment to eliminate residual stress in the printing process and improve the mechanical properties of the cone pile (1); S4, preparing a bisphosphonate drug coating, using a spraying device to evenly spray a mixed solution of phosphonate and hydroxyapatite on the surface of the cone pile (1) to form a drug coating layer, and then drying it naturally; S5, evaluating the quality of the prepared cone pile (1), and packaging and sterilizing the cone pile after the quality evaluation is qualified; Step S5 includes: S51, placing the prepared cone pile (1) on a rotating table, dividing the cone pile (1) into n acquisition areas, performing image acquisition several times on each acquisition area of ​​the cone pile (1), obtaining several quality inspection acquisition images of each acquisition area, and obtaining a surface unevenness coefficient of the corresponding acquisition area based on the several quality inspection acquisition images of each acquisition area; S52, measuring the internal porosity corresponding to n collection areas of the cone pile (1) by micro-CT scanning; S53, using an ultrasonic detector to measure the elastic modulus corresponding to n collection areas of the cone pile (1); S54, using a 3D scanner to obtain the size parameters of the cone pile (1); S55, judging whether the corresponding cone pile (1) is qualified based on the surface unevenness coefficient, internal porosity, elastic modulus, several dimensional parameters corresponding to the n acquisition areas and the reference surface unevenness coefficient range, reference internal porosity range, reference elastic modulus range and several reference dimensional parameter ranges of the cone pile (1); if any one of the items is unqualified, the cone pile (1) is eliminated; if all items are qualified, the quality grade of the corresponding cone pile (1) is calculated, and the cone pile (1) is graded based on the size specification and quality grade of the corresponding cone pile (1); Step S51 includes: S511, inputting a plurality of quality inspection collection images of each collection area into the trained cone pile surface uneven area recognition model, identifying a plurality of surface uneven areas of each quality inspection collection image, and obtaining a plurality of surface uneven area images of each quality inspection collection image; S512, obtaining the pixel value of each pixel point of each surface unevenness area image of each quality inspection acquisition image, and calculating the pixel mean value of the adjacent pixels of each pixel point of each surface unevenness area image, and using it as the assisting pixel of the corresponding pixel point of the corresponding surface unevenness area image of the corresponding quality inspection acquisition image; S513, taking the quotient of the sum of the assisting pixels at the same pixel position of each quality inspection acquisition image and the total number of quality inspection acquisition images acquired in the corresponding acquisition area as the reference pixel at each pixel position, and taking the image composed of all the reference pixels as the discrimination image; S514, taking the quality inspection acquisition image with the highest pixel among all the quality inspection acquisition images acquired in the same acquisition area as the comparison image, calculating the absolute value of the pixel value of the reference pixel at each pixel point position of the discrimination image and the corresponding pixel point position of the comparison image, when the absolute value of the pixel value of the reference pixel at each pixel point position of the discrimination image and the corresponding pixel point position of the comparison image is greater than the preset pixel difference, marking the corresponding pixel point position as an uneven position, and taking the quotient of the absolute value of the pixel value of the reference pixel at each pixel point position of the discrimination image and the corresponding pixel point position of the comparison image and the preset pixel difference as the uneven degree coefficient of the corresponding uneven position; S515, taking the sum of the unevenness coefficients of all uneven positions on the contrast image of each acquisition area as the surface unevenness coefficient of the corresponding acquisition area; A method for preparing a tantalum metal porous cone pile loaded with bisphosphonate is used to prepare a cone pile (1). The cone pile (1) is made of tantalum metal using 3D printing technology. The cone pile (1) is a conical structure. The cone pile (1) comprises a cone bottom, a cone body and a cone layer. The surface of the cone pile (1) is treated with bisphosphonate spraying.

2. The method for preparing a tantalum metal porous cone pile loaded with bisphosphonate according to claim 1, characterized in that: The tapered pile (1) has a taper of 0.25-0.5; The cone bottom diameter is 5-10 mm; The cone height is 20-30 mm; The cone layer is in the form of a trumpet-shaped barbed structure with an opening downward, and there is a gap of 0.5 mm between adjacent cone layers.

3. The method for preparing a tantalum metal porous cone pile loaded with bisphosphonate according to claim 1, characterized in that: The cone pile (1) is a porous structure, and the interior of the cone pile (1) has a pore structure with a pore size of 200 μm-500 μm, and a porosity of 50%-80%.

4. The method for preparing a tantalum metal porous cone pile loaded with bisphosphonate according to claim 1, characterized in that: The elastic modulus of the tapered pile (1) is between 10 GPa and 60 GPa.

5. The method for preparing a tantalum metal porous cone pile loaded with bisphosphonate according to claim 1, characterized in that: The cone pile (1) is sprayed with hydroxyapatite to load the bisphosphonate onto the surface of the cone pile (1), thereby forming a uniform drug coating layer; The dosage of sprayed bisphosphonate drugs is 1mg / cm³-5mg / cm³.

6. The method for preparing a bisphosphonate-loaded tantalum metal porous cone pile according to claim 1, characterized in that: Packaging and sterilization The cone pile (1) is sterilized by gamma ray or ethylene oxide sterilization to ensure a sterile state.

7. The method for preparing a tantalum metal porous cone pile loaded with bisphosphonate according to claim 1, characterized in that: Calculate the quality grade of the tapered pile (1): (1); among which, is the quality grade of the cone pile (1), is the logarithm to base e, is the weight of the surface unevenness coefficient, is the surface unevenness coefficient of the jth acquisition area, is the maximum value of the reference surface unevenness coefficient of the jth acquisition area, is the minimum value of the reference surface unevenness coefficient of the jth acquisition area, is the weight of internal porosity, is the internal porosity of the jth collection area, is the maximum value of the reference internal porosity of the jth acquisition area, is the minimum value of the reference internal porosity of the jth acquisition area, is the weight of the elastic modulus, is the elastic modulus of the jth acquisition area, is the maximum value of the reference elastic modulus of the jth acquisition area, is the minimum value of the reference elastic modulus of the jth acquisition area, is the weight of the size parameter, is the value of the i-th size parameter, is the maximum value of the i-th size parameter, is the minimum value of the i-th dimension parameter, the dimension parameters including the taper, cone bottom diameter, cone height and cone layer gap of the cone pile (1), The round-up symbol.

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