High-strength progressive bone plate and method of making

Abstract

The application provides a high-strength progressive bone plate and a preparation method, and the preparation method comprises the following steps: preparing a reinforcing material and a base material, preparing the reinforcing material into a progressive structure multi-filled pore bone plate structure framework, the progressive structure multi-filled pore bone plate structure framework is provided with a high-density reinforcing section, a medium-density supporting section and a low-density connecting section, and the prepared multi-filled pore bone plate structure framework and the base material are uniformly mixed, pressure-formed and sintered to obtain a progressive bone plate finished material. The application solves the technical problems that the existing bone plate is prepared by mixing carbon fiber filaments and polyether ether ketone powder, the carbon fiber filaments are uniformly distributed in the polyether ether ketone base in the form of prepreg tapes, the interface bonding force between the two is low, and when the bone plate is applied to a part of the human body with high bearing force, the bone plate is prone to breakage and delamination. The application can be widely applied to the preparation of bone plates.

Description

TECHNICAL FIELD

[0001] The present application relates to a bone plate, in particular to a high-strength progressive bone plate and a preparation method. BACKGROUND

[0002] The bone plate is a commonly used device in bone fracture internal fixation, which plays a role in fixing and supporting the human body fracture, and can reduce the stress of the fracture end and promote the normal healing of the fracture.

[0003] The manufacturing method of the existing bone plate is usually prepared by using pure metal materials, but due to the large difference between the elastic modulus of the metal material and the elastic modulus of the human cortical bone, stress shielding and other problems are easily caused during use. In order to solve this problem, more and more continuous carbon fiber or chopped carbon fiber materials and polyether ether ketone are mixed to be prepared, and are processed by injection molding, high-temperature pressing and other methods. In such a bone plate, the carbon fiber wire is uniformly distributed in the polyether ether ketone matrix in the form of a prepreg tape, and the interfacial bonding force between the two is low. When applied to parts of the human body that bear high forces, the bone plate is prone to breakage, delamination and other technical problems. SUMMARY

[0004] The present application is directed to the above technical problems, and provides a high-strength progressive bone plate and a preparation method. In the high-strength progressive bone plate and the preparation method, the density of the middle position of the bone plate is higher, and the density of the two sides gradually decreases, forming a progressive structure. The high-density structure at the center position provides high-strength support for the bone plate.

[0005] More importantly, the preparation method uses high-molecular fiber materials or metal materials mixed with polyether ether ketone powder to be prepared, and the bonding force between the two is high, which can be easily applied to parts of the human body that bear high forces. The bone plate is not prone to breakage, delamination and other technical problems.

[0006] Therefore, the technical solution of the present application is a high-strength progressive bone plate, which is provided with a multi-filled pore bone plate structure framework, the multi-filled pore bone plate structure framework includes a high-density reinforcing section, a medium-density supporting section and a low-density connecting section, the high-density reinforcing section is located at the middle position of the multi-filled pore bone plate structure framework, the medium-density supporting section is located at both sides of the high-density reinforcing section, and the low-density connecting section is located outside the medium-density supporting section.

[0007] The multi-filled pore bone plate structure framework is formed by interlacing wires, the density of the interlaced wires is unevenly distributed, and the interlaced wires form filled pores between them, and the size of the filled pores is also unevenly distributed.

[0008] The density of the interwoven wires on the multi-pore filling bone plate structure framework gradually changes, and the density of the interwoven wires on the multi-pore filling bone plate structure framework gradually decreases along the direction of the high-density reinforcing section, the medium-density supporting section and the low-density connecting section;

[0009] The size of the filling pores on the multi-pore filling bone plate structure framework also gradually changes, and the size of the filling pores gradually increases along the direction of the high-density reinforcing section, the medium-density supporting section and the low-density connecting section;

[0010] The filling pores are filled with a high molecular material, and the multi-pore filling bone plate structure framework is coated with a layer of high molecular material on the outside;

[0011] The multi-pore filling bone plate structure framework is provided with a plurality of fixing holes, and the plurality of fixing holes penetrate through the high molecular material coated on the outside of the multi-pore filling bone plate structure framework;

[0012] The surface of one side of the bone plate is provided with a concave arc surface.

[0013] Preferably, the number of fixing holes is six, and one fixing hole is arranged on the high-density reinforcing section near the left and right sides, respectively, and one fixing hole is arranged on each of the two medium-density supporting sections at the middle position and near the outer side, respectively.

[0014] Preferably, the filling pores on the high-density reinforcing section are small square filling pores;

[0015] The filling pores at the middle position on the medium-density supporting section are small square filling pores, and the filling pores at the upper and lower side positions on the medium-density supporting section are rectangular filling pores;

[0016] The filling pores at the middle position on the low-density connecting section are small square filling pores, and the filling pores at the upper and lower side positions on the low-density connecting section are wide square filling pores;

[0017] The width of the small square filling pores at the middle position on the low-density connecting section is smaller than the width of the small square filling pores at the middle position on the medium-density supporting section.

[0018] Preferably, the outer surfaces of the bone plate are smoothly transitioned through round corners.

[0019] A preparation method of the above-mentioned high-strength progressive bone plate, preparing a reinforcing material and a matrix material, the reinforcing material being a high molecular fiber material or a metal material, and the matrix material being a high molecular material, the preparation method comprising the following steps:

[0020] Step (1): preparing the reinforcing material into a multi-pore filling bone plate structure framework;

[0021] Step (2): Put the prepared multi-filled porosity bone plate structure framework and the polymer material into the cavity mold respectively, use the oscillation method to uniformly fill the polymer material into the filled porosity of the multi-filled porosity bone plate structure framework, and then pressurize the uniformly mixed material through the cavity mold. After pressurization molding, a gradual bone plate semi-finished product is obtained.

[0022] Step (3): Put the gradual bone plate semi-finished product into a high-temperature oven for sintering. After sintering, a high-strength gradual bone plate is obtained.

[0023] Preferably, when the reinforcing material is titanium alloy wire and the matrix material is polyether ether ketone powder, the preparation method comprises the following steps:

[0024] Step (1): Prepare the titanium alloy wire into a multi-filled porosity titanium alloy bone plate structure framework, and the preparation method is wire weaving.

[0025] The diameter of the titanium alloy wire is 460-520 μm, and the particle size of the polyether ether ketone powder is 350-440 μm.

[0026] The pore size of the high-density reinforcing section on the multi-filled porosity titanium alloy bone plate structure framework is 250-350 μm, and the porosity is 15-25%. The pore size of the medium-density supporting section is 370-450 μm, and the porosity is 27-35%. The pore size of the low-density connecting section is 370-550 μm, and the porosity is 37-45%.

[0027] Step (2): Put the prepared multi-filled porosity titanium alloy bone plate structure framework into the cavity mold, then fill the polyether ether ketone powder in the cavity mold, and use the oscillation method to uniformly fill the polyether ether ketone powder into the filled porosity of the multi-filled porosity titanium alloy bone plate structure framework. The oscillation method is mechanical oscillation or ultrasonic oscillation, and the oscillation time is 26-33 min. After uniform filling, the mixed material is pressurized and molded through the cavity mold. The pressurization molding method is vacuum hot isostatic pressing or vacuum cold isostatic pressing. The pressurization pressure is 150-220 MPa, and the pressure holding time is 24-38 min. After pressurization molding, a gradual bone plate semi-finished product is obtained.

[0028] Step (3): Put the gradual bone plate semi-finished product into a high-temperature oven for sintering. The sintering method is hot pressing sintering, vacuum hot isostatic pressing sintering, gas pressure sintering, microwave sintering, discharge plasma sintering or solid state metal sintering. The sintering temperature is 305-386℃, and the sintering time is 1.1-1.7 h. After sintering, a high-strength gradual bone plate is obtained.

[0029] Preferably, the diameter of the titanium alloy wire in step (1) is 500 μm, and the particle size of the polyether ether ketone powder is 400 μm;

[0030] The pore size of the high-density reinforcing section in step (1) is 300 μm, and the porosity is 20%; the pore size of the medium-density supporting section is 400 μm, and the porosity is 30%; the pore size of the low-density connecting section is 500 μm, and the porosity is 40%;

[0031] The oscillation mode in step (2) is ultrasonic oscillation, and the oscillation time is 30 min;

[0032] The pressure forming mode in step (2) is vacuum hot isostatic pressing, the pressure intensity is 200 MPa, and the pressure holding time is 30 min;

[0033] The sintering mode in step (3) is vacuum hot isostatic sintering, the sintering temperature is 345 ℃, and the sintering time is 1.5 h.

[0034] Preferably, when the reinforcing material is carbon fiber wire and the matrix material is polyether ether ketone powder, the preparation method comprises the following steps:

[0035] Step (1): carbon fiber wire is prepared into a multi-filled-pore carbon fiber bone plate structure framework, and the preparation mode is wire weaving;

[0036] The diameter of the carbon fiber wire is 8 μm-13 μm, the number of single filaments is 6K-12K, and the particle size of the polyether ether ketone powder is 20 μm-29 μm;

[0037] The pore size of the high-density reinforcing section on the multi-filled-pore carbon fiber bone plate structure framework is 250 μm-350 μm, and the porosity is 15%-25%; the pore size of the medium-density supporting section is 370 μm-450 μm, and the porosity is 27%-35%; the pore size of the low-density connecting section is 370-550 μm, and the porosity is 37%-45%;

[0038] Step (2): the prepared multi-filled-pore carbon fiber bone plate structure framework is placed in a cavity mold, then polyether ether ketone powder is filled in the cavity mold, the filling mode adopts multiple equal fillings, after each filling is completed, the polyether ether ketone powder is uniformly filled into the filling pores of the multi-filled-pore carbon fiber bone plate structure framework through an oscillation mode, the oscillation mode is mechanical oscillation or ultrasonic oscillation, the oscillation time is 26 min-33 min, after uniform filling, the mixed material is pressure formed through the cavity mold, the pressure forming mode is vacuum hot isostatic pressing or vacuum cold isostatic pressing, the pressure intensity is 110 MPa-190 MPa, and the pressure holding time is 22 min-28 min, after pressure forming, a gradual bone plate semi-finished product is obtained;

[0039] Step (3): the progressive bone plate semi-finished product is placed into a high-temperature oven for sintering, the sintering mode is hot-press sintering, vacuum hot isostatic sintering, gas pressure sintering, microwave sintering, discharge plasma sintering or solid-state metal sintering, the sintering temperature is 305-365 DEG C, the sintering time is 0.6-1.2h, after sintering, a high-strength progressive bone plate is obtained.

[0040] Preferably, the diameter of the carbon fiber wire in step (1) is 10 microns, the number of single filaments is 10K, and the particle size of the polyether ether ketone powder is 25 microns.

[0041] The pore size of the high-density reinforcing section in step (1) is 300 microns, the porosity is 20%, the pore size of the medium-density supporting section is 400 microns, the porosity is 30%, and the pore size of the low-density connecting section is 500 microns, the porosity is 40%;

[0042] The oscillation mode in step (2) is ultrasonic oscillation, and the oscillation time is 30 minutes.

[0043] The pressure forming mode in step (2) is a vacuum cold isostatic pressing mode, the pressure intensity is 160 MPa, and the pressure holding time is 25 minutes.

[0044] The sintering mode in step (3) is discharge plasma sintering, the sintering temperature is 343 DEG C, and the sintering time is 1h.

[0045] Preferably, the reinforcing material can also use degradable metal materials.

[0046] The beneficial effects of the present application are:

[0047] 1. By providing three density sections on the bone plate, the actual positions of the three density sections can be adjusted according to the different positions of the patient's bone injury, the porosity and pore size of different parts of the bone plate are adjusted to optimize the biomechanical properties of the bone plate, the bone plate provides biomechanical internal fixation for the implanted bone tissue, and at the same time, it can also ensure that the bone tissue receives sufficient stress stimulation to stimulate the self-repairing function of the bone tissue, realize the mechanical compatibility between the bone plate and the human bone tissue, and at the same time, save materials and reduce production cost.

[0048] The high-density reinforcing section is located at the position where the bone injury is the most serious, and is the position where the bone plate bears the most stress, and the pore size and porosity specification parameters can ensure that the strength of the center part of the bone plate bearing the most stress is high, and through sufficient strength, the mechanical support of the bone plate is realized, if the parameters are lower than the range, the center part of the bone plate is easy to break in actual use.

[0049] The pore size and porosity specification parameters of the middle-density supporting section can play a good auxiliary supporting role on the periphery of the bone damage position, and can also play an auxiliary role on the fixation of the high-density reinforcing section, increase the stability of the fixation of the high-density reinforcing section, and prevent the periphery of the bone damage position from being interfered by stress to cause secondary damage.

[0050] The low-density connecting section adopts a relatively large size of pore size and porosity, because the stress on both sides of the bone plate is small when the bone plate is actually stressed, and this range matches the actual stress, avoiding the stress shielding effect and avoiding the loosening of the bone plate after long-term use.

[0051] 2. The bone plate is prepared into a multi-filled pore bone plate structure framework by using a reinforcing material, and then the multi-filled pore bone plate structure framework and the base material are uniformly filled and mixed by ultrasonic oscillation, and then the mixed material is pressurized by vacuum hot isostatic pressing or vacuum cold isostatic pressing process, and finally the formed material is put into a high-temperature oven for sintering.

[0052] It can be seen that each step can increase the strength of the bone plate, and after the completion of the overall steps, the strength of the bone plate is obviously increased, so that the bone plate can withstand a higher impact force when in use, and a series of quality problems such as damage and fragmentation of the bone plate during use are avoided to the greatest extent, and the mechanical properties of the bone plate are greatly improved, and the long-term stable use of the bone plate is ensured.

[0053] 3. The bone plate product prepared by using degradable metal materials has obvious bone induction ability, specifically, the degradable metal materials used in the bone plate product, such as degradable zinc alloy and degradable magnesium alloy, will react with the body fluid in the human body, and the reaction will produce Mg ions and Zn ions, and the two kinds of ions can promote bone regeneration through three main strategies, including balancing osteoblasts and osteoclasts, adjusting the immune microenvironment, and promoting bone angiogenesis, realizing the bone induction effect, and effectively accelerating the recovery speed of the fracture site.

[0054] 4. The bone plate is prepared by mixing and filling degradable metal materials and medical plastics, and compared with the traditional preparation using metal materials, the overall weight is lighter, which can obviously reduce the bone loss of patients and avoid a series of chain symptoms such as osteoporosis and calcification of bone. DETAILED DESCRIPTION

[0055] Figure 1 is a perspective view of the bone plate product of the present application;

[0056] Figure 2 is another perspective view of the bone plate product of the present application;

[0057] Figure 3 This is a three-dimensional diagram of the skeleton structure of the multi-filled pore bone plate of the present invention;

[0058] Figure 4 This invention Figure 3 Enlarged view of point A in the middle.

[0059] Explanation of symbols in the figure

[0060] 1. High-density reinforcement section; 2. Medium-density support section; 3. Low-density connection section; 4. Fixing hole; 5. Concave arc surface; 6. Multi-filled pore plate structure skeleton; 7. Rounded corners; 8. Silk thread; 9. Filled pores. DETAILED DESCRIPTION

[0061] The present invention will be further described below with reference to the embodiments.

[0062] pass Figures 1-4 It can be seen that the high-strength progressive bone plate is provided with a multi-filled pore bone plate structural skeleton 6, which includes a high-density reinforcement section 1, a medium-density support section 2 and a low-density connection section 3. The high-density reinforcement section 1 is located in the middle position of the multi-filled pore bone plate structural skeleton 6, the medium-density support section 2 is located on both sides of the high-density reinforcement section 1, and the low-density connection section 3 is located on the outside of the medium-density support section 2.

[0063] The multi-filled pore bone plate structural skeleton 6 is formed by interwoven threads 8 , the density of the interwoven threads 8 is unevenly distributed, and filled pores 9 are formed between the interwoven threads 8 , and the sizes of the filled pores 9 are also unevenly distributed.

[0064] The density of the interwoven threads 8 on the multi-filled pore bone plate structure skeleton 6 changes gradually, and the density of the interwoven threads 8 on the multi-filled pore bone plate structure skeleton 6 decreases gradually along the direction of the high-density reinforcement section 1, the medium-density support section 2 and the low-density connection section 3.

[0065] The sizes of the filling pores 9 on the multi-filling pore bone plate structural skeleton 6 also change gradually, and the sizes of the filling pores 9 gradually increase along the directions of the high-density reinforcement section 1, the medium-density support section 2 and the low-density connection section 3.

[0066] In actual use, the position of the high-density reinforced section 1 is the location where the contact bone damage is most serious and the location where the bone plate is subjected to the greatest force. The pore size and porosity specification parameters can ensure the high strength of the central part of the bone plate where the force is greatest, and achieve the mechanical support of the bone plate through sufficient strength. If it is lower than this parameter range, the central part of the bone plate is prone to breakage during actual use.

[0067] The pore size and porosity specification of the middle-density supporting section 2 can provide good auxiliary support to the periphery of the bone injury position, and can also assist the fixation of the high-density reinforcing section 1, thereby increasing the stability of the fixation of the high-density reinforcing section 1 and preventing the periphery of the bone injury position from being interfered by stress and causing secondary injury.

[0068] The low-density connecting section 3 has a relatively large pore size and porosity because the two sides of the bone plate are less stressed in actual stress, and the range matches the actual stress, thereby avoiding the stress shielding effect and preventing the bone plate from loosening after long-term use.

[0069] In summary, by arranging the three-density sections, the actual positions of the three-density sections can be adjusted according to the different positions of the bone injury of the patient, and the porosity and pore size of different parts of the bone plate are adjusted to optimize the biomechanical properties of the bone plate. The bone plate can provide biomechanical internal fixation for the bone tissue of the implant site, and can also ensure that the bone tissue is subjected to sufficient stress stimulation to stimulate the self-repairing function of the bone tissue, thereby achieving the mechanical compatibility between the bone plate and the human bone tissue. In addition, the material can be saved, and the production cost can be reduced.

[0070] The high-molecular material is filled in the filling pores 9, and the outside of the multi-filled-pore bone plate structure framework 6 is coated with a layer of high-molecular material.

[0071] The multi-filled-pore bone plate structure framework 6 is provided with a plurality of fixing holes 4, and the plurality of fixing holes 4 penetrate through the high-molecular material coated on the outside of the multi-filled-pore bone plate structure framework 6.

[0072] The surface of one side of the bone plate is provided with a concave arc surface 5, and the shape of the concave arc surface 5 is arranged to better adapt to the anatomical structure of the human skeleton, so that the bone plate better fits the human skeleton. The bending curvature of the concave surface 5 is the same as the curvature of the damaged bone, which can further promote the anatomical reduction of the bone and achieve better fixation effect.

[0073] The plurality of fixing holes 4 are arranged at the positions of the high-density reinforcing section and the middle-density supporting section.

[0074] The filling pores 9 on the high-density reinforcing section 1 are small square filling pores, the filling pores 9 on the middle-density supporting section 2 located at the middle position are small square filling pores, the filling pores 9 on the middle-density supporting section located at the upper and lower positions are rectangular filling pores, the filling pores 9 on the low-density connecting section 3 located at the middle position are small square filling pores, and the filling pores 9 on the low-density connecting section 3 located at the upper and lower positions are wide square filling pores.

[0075] The width of the small square filling hole in the middle position of the low-density connecting section 3 is smaller than the width of the small square filling hole in the middle position of the medium-density supporting section 2.

[0076] The number of the fixing holes 4 is six, one fixing hole 4 is arranged at each of the positions close to the left and right sides of the high-density reinforcing section 1, and one fixing hole 4 is arranged at each of the middle positions and the positions close to the outer sides of the two medium-density supporting sections 2.

[0077] The distribution of the fixing holes 4 can ensure that the both sides and the middle of the bone plate are effectively fixed, and the stability of the overall fixation of the bone plate is increased.

[0078] Specifically, the fixing holes 4 are arranged at the positions close to the left and right sides of the high-density reinforcing section 1, the middle positions and the positions close to the outer sides of the two medium-density supporting sections 2, which can ensure that the positions of the high-density reinforcing section 1 and the medium-density supporting section 2 are fully covered and fixed, and since the low-density connecting section 3 mainly plays an auxiliary fixing role, the fixing hole 4 arranged at the position close to the outer side of the medium-density supporting section 2 can also play an auxiliary supporting and fixing role for the low-density connecting section 3, thereby ensuring that each position of the bone plate is effectively fixed during fixation.

[0079] The number of the fixing holes 4 should not be too large, because if the number of the fixing holes 4 is too large, the number of the drilled holes in the bone will be larger, the area of the stripped periosteum will be larger, and the damage to the bone will be larger, and if the number of the fixing holes 4 is too large, the distance between the adjacent fixing holes 4 will be smaller, and the bending amount between the adjacent fixing holes 4 will be smaller, so that the bone plate cannot be closely combined with the bone during the operation, which will cause the bone plate to press the periosteum and is not conducive to the effective healing of the fracture site.

[0080] The diameter of the fixing hole 4 should not be smaller than 1 / 4 of the width of the bone plate, and if the outer diameter of the fixing hole 4 is smaller than 1 / 4 of the width of the bone plate, the locking area of the fixing screw to the bone plate will be smaller, which will cause the bone plate to be not firmly fixed, the stress distribution to be uneven, and even cause secondary damage to the damaged bone.

[0081] The outer surface of the bone plate is provided with a round corner 7, and the round corner 7 can prevent the bone plate from causing damage to the surface of the bone tissue after being fixed.

[0082] A preparation method of the above-mentioned high-strength progressive bone plate, which comprises the following steps:

[0083] Step (1): preparing the reinforcing body material into a multi-filling-hole bone plate structure skeleton 6.

[0084] Step (2): Put the prepared multi-filled-pore bone plate structure framework 6 and the polymer material into the cavity mold respectively, fill the polymer material into the filled-pore 9 of the multi-filled-pore bone plate structure framework 6 in an oscillation mode, and then pressurize the uniformly mixed material through the cavity mold to obtain the gradual bone plate semi-finished product.

[0085] Vacuum cold isostatic pressing is commonly used for difficult-to-press powders, such as hard metals.

[0086] Vacuum hot isostatic pressing is mainly applied to the molding of high-performance powder material products, such as industrial production of powder metallurgy high-temperature alloy, powder metallurgy high-speed steel, carbon material, ceramic material, etc.

[0087] The oscillation mode includes ultrasonic oscillation and mechanical oscillation, and the difference between the two is that the uniformity of ultrasonic oscillation is higher than that of mechanical oscillation. When the mixing precision requirement is high, ultrasonic oscillation mode is usually used, and mechanical oscillation mode is used instead.

[0088] Step (3): Put the gradual bone plate semi-finished product into a high-temperature oven for sintering, and obtain the high-strength gradual bone plate after sintering.

[0089] Example 1

[0090] When the reinforcing material is titanium alloy wire and the matrix material is polyether ether ketone powder, the preparation method includes the following steps:

[0091] Step (1): Prepare the titanium alloy wire into a multi-filled-pore titanium alloy bone plate structure framework, and the preparation method is wire weaving.

[0092] The diameter of the titanium alloy wire is 460-520 μm, and the particle size of the polyether ether ketone powder is 350-440 μm.

[0093] The pore size of the high-density reinforcing section on the multi-filled-pore titanium alloy bone plate structure framework is 250-350 μm, and the porosity is 15-25%; the pore size of the medium-density supporting section is 370-450 μm, and the porosity is 27-35%; the pore size of the low-density connecting section is 370-550 μm, and the porosity is 37-45%.

[0094] Step (2): Put the prepared multi-filled pore titanium alloy bone plate structure framework into the cavity mold, then fill the polyether ether ketone powder in the cavity mold, and fill the polyether ether ketone powder into the filling pores 9 of the multi-filled pore titanium alloy bone plate structure framework by multiple equal filling, and after each filling, the polyether ether ketone powder is uniformly filled into the filling pores 9 of the multi-filled pore titanium alloy bone plate structure framework by oscillation, the oscillation mode is mechanical oscillation or ultrasonic oscillation, the oscillation time is 26 min-33 min, and after uniform filling, the mixed material is pressure formed by the cavity mold, the pressure forming mode is vacuum hot isostatic pressing or vacuum cold isostatic pressing, the pressure intensity is 150 MPa-220 MPa, and the pressure holding time is 24 min-38 min. After pressure forming, a gradual bone plate semi-finished product is obtained.

[0095] Step (3): Put the gradual bone plate semi-finished product into a high-temperature oven for sintering, the sintering mode is hot-pressing sintering, vacuum hot isostatic sintering, gas pressure sintering, microwave sintering, discharge plasma sintering or solid-state metal sintering, the sintering temperature is 305℃-386℃, and the sintering time is 1.1h-1.7h. After sintering, a high-strength gradual bone plate is obtained.

[0096] In example 1, the diameter of the titanium alloy wire in step (1) is 500μm, and the particle size of the polyether ether ketone powder is 400μm.

[0097] The pore diameter of the high-density reinforcing section in step (1) is 300μm, and the porosity is 20%, the pore diameter of the medium-density supporting section is 400μm, and the porosity is 30%, and the pore diameter of the low-density connecting section is 500μm, and the porosity is 40%.

[0098] The oscillation mode in step (2) is ultrasonic oscillation, and the oscillation time is 30min.

[0099] The pressure forming mode in step (2) is vacuum hot isostatic pressing, the pressure intensity is 200MPa, and the pressure holding time is 30min.

[0100] The sintering mode in step (3) is vacuum hot isostatic sintering, the sintering temperature is 345℃, and the sintering time is 1.5h.

[0101] The titanium alloy material has good corrosion resistance, biocompatibility, superior mechanical properties and fatigue resistance, good wear resistance in the combination, and can effectively improve the mechanical properties of the polyether ether ketone material and ensure the strength of the bone plate.

[0102] Example 2

[0103] When the reinforcing material is carbon fiber wire and the matrix material is polyether ether ketone powder, the preparation method comprises the following steps:

[0104] Step (1): Carbon fiber filaments are prepared into a multi-filled porous carbon fiber bone plate structure framework by filament weaving.

[0105] The diameter of the carbon fiber filaments is 8-13 μm, the number of filaments is 6K-12K, and the particle size of the polyether ether ketone powder is 20-29 μm.

[0106] The high-density reinforcing section of the multi-filled porous carbon fiber bone plate structure framework has a pore size of 250-350 μm and a porosity of 15-25%, the medium-density supporting section has a pore size of 370-450 μm and a porosity of 27-35%, and the low-density connecting section has a pore size of 370-550 μm and a porosity of 37-45%.

[0107] Step (2): The prepared multi-filled porous carbon fiber bone plate structure framework is placed in a cavity mold, and then polyether ether ketone powder is filled in the cavity mold. The filling method is multiple equal filling. After each filling, the polyether ether ketone powder is uniformly filled into the filling pores 9 of the multi-filled porous carbon fiber bone plate structure framework by oscillation, such as mechanical oscillation or ultrasonic oscillation, for 26-33 min. After uniform filling, the mixed material is pressurized and formed by the cavity mold. The pressurized forming method is vacuum hot isostatic pressing or vacuum cold isostatic pressing. The pressure is 110-190 MPa, and the pressure holding time is 22-28 min. After pressurized forming, a gradual bone plate semi-finished product is obtained.

[0108] Step (3): The gradual bone plate semi-finished product is placed in a high-temperature oven for sintering. The sintering method is hot-pressing sintering, vacuum hot isostatic pressing sintering, gas pressure sintering, microwave sintering, discharge plasma sintering, or solid-state metal sintering. The sintering temperature is 305-365℃, and the sintering time is 0.6-1.2 h. After sintering, a high-strength gradual bone plate is obtained.

[0109] Hot-pressing sintering refers to a sintering process in which materials are accelerated to flow, rearrange, and densify under a certain external force (generally 10-40 MPa according to the strength of the mold material). The temperature required for hot-pressing sintering is 100-150℃ lower than that required for normal pressure sintering, but the driving force for hot-pressing sintering is 20-100 times greater than that for normal pressure sintering.

[0110] Hot-pressing sintering can achieve better material mechanical properties, reduce sintering time or sintering temperature, and reduce the amount of covalent bond ceramic sintering aids, thereby improving the high-temperature mechanical properties of the material.

[0111] The basic principle of vacuum hot isostatic sintering is to use high-pressure gas as a pressure medium to act on the material (including the enclosed powder, blank or sintered body), so that it is subjected to balanced pressure in all directions during heating, and the material densification is achieved by the combined action of high temperature and high pressure.

[0112] Using vacuum hot isostatic sintering can reduce the sintering temperature and shorten the sintering time, at the same time, it can greatly reduce or even not use sintering aids, improve the performance and reliability of ceramics, and is especially suitable for manufacturing complex-shaped products.

[0113] Gas pressure sintering refers to the application of a certain gas pressure during high-temperature sintering, usually in the range of 1-10 MPa, in order to inhibit the decomposition and weight loss of the material at high temperature, thereby increasing the sintering temperature and further promoting the densification of the material to obtain high-density products. Gas pressure sintering and vacuum hot isostatic sintering both use gas as a pressure transfer method.

[0114] Compared with hot pressing sintering and vacuum hot isostatic sintering, the biggest advantage of gas pressure sintering is that it can reduce the investment cost, prepare better performance, be suitable for complex-shaped products, and realize batch production.

[0115] Microwave sintering is commonly used for sintering of ceramic materials, which uses the dielectric loss of ceramic materials in the microwave electromagnetic field to achieve sintering temperature, thereby realizing the sintering and densification of ceramics.

[0116] Discharge plasma sintering, also known as "plasma activated sintering", is a new material preparation technology that directly applies a large pulse current to the mold or sample, and realizes material sintering through thermal effect or other field effect.

[0117] Discharge plasma sintering can ensure the uniformity of heating temperature, has fast heating speed, low sintering temperature, short sintering time, high production efficiency, and can produce products with fine and uniform organization, maintain the natural state of raw materials, and obtain high-density materials. It is commonly used for sintering gradient materials and complex workpieces.

[0118] Solid-state metal sintering is a sintering process using powdered materials, which can be molded into the desired shape, and can produce complex-shaped and delicate-designed parts. In addition, solid-state sintering can improve the mechanical properties of materials. Compared with traditional processes, the cycle time of solid-state sintering is shorter, which means that the sintering process can be completed in a few minutes instead of several hours or longer. This high productivity and rapid material development capability makes solid-state metal sintering more widely used.

[0119] More importantly, solid-state metal sintering can be performed at a lower temperature compared to conventional sintering processes, which is very advantageous because it helps to minimize energy consumption and reduce the risk of thermal damage to the sintered material. In addition, solid-state metal sintering is a versatile process that can be used for the densification of low-melting-point metals, ultra-high-temperature ceramics, and even the bonding of dissimilar materials that require non-uniform temperatures. Furthermore, solid-state sintering can be used for sintering both porous and fully dense components, making it a widely applicable process.

[0120] In summary, solid-state metal sintering has numerous advantages, including the ability to produce complex shapes, better mechanical properties, shorter sintering times, lower sintering temperatures, versatility, high-precision process control, and cost-effectiveness, making it an ideal manufacturing method for a wide range of applications.

[0121] In Example 2, the carbon fiber filament in step (1) has a diameter of 10 μm and a single filament count of 10K, and the polyether ether ketone powder has a particle size of 25 μm.

[0122] The high-density reinforcement section in step (1) has a pore size of 300 μm and a porosity of 20%, the medium-density support section has a pore size of 400 μm and a porosity of 30%, and the low-density connecting section has a pore size of 500 μm and a porosity of 40%.

[0123] The oscillation method in step (2) is ultrasonic oscillation, and the oscillation time is 30 min.

[0124] The pressure forming method in step (2) is vacuum cold isostatic pressing, the pressure intensity is 160 MPa, and the pressure holding time is 25 min.

[0125] The sintering method in step (3) is spark plasma sintering, the sintering temperature is 343 ℃, and the sintering time is 1 h.

[0126] Carbon fiber materials have the characteristics of high strength and low modulus, which can ensure the strength of the bone plate and avoid the problem of stress shielding effect caused by the high elastic modulus of traditional metal materials.

[0127] The fixing hole 4 is processed by hot extrusion or hot forming.

[0128] Existing bone plate fixing holes are usually machined, but machining holes can damage the continuity of the reinforcement structure and affect the mechanical properties around the holes. Hot extrusion or hot forming can effectively ensure the continuity of the reinforcement around the holes and thus ensure the mechanical properties around the holes.

[0129] The reinforcing material can also use degradable metal materials, which include degradable zinc alloy wires, degradable zinc alloy powders, degradable magnesium alloy wires, or degradable magnesium alloy powders.

[0130] The degradable metal materials will react with body fluids in the human body and gradually be corroded and degraded by the body fluids. For example, when the degradable zinc alloy wires or the degradable magnesium alloy wires react with the body fluids, magnesium ions or zinc ions are generated, which are released from the fixing holes of the bone plate. These two ions are the most important trace elements in bone tissue and indispensable active ingredients in human biological activities, and play an important role in bone tissue repair, which can effectively accelerate the recovery speed of the fracture site.

[0131] Example 3

[0132] When the reinforcing material is titanium alloy powder and the matrix material is polyether ether ketone powder, the preparation method includes the following steps:

[0133] Step (1): The titanium alloy powder is prepared into a multi-filled porous titanium alloy bone plate structure framework by 3D printing.

[0134] The particle size of the titanium alloy powder is 80-120 μm, and the particle size of the polyether ether ketone powder is 120-290 μm.

[0135] The pore size of the high-density reinforcing section 1 on the multi-filled porous titanium alloy bone plate structure framework is 250-350 μm, and the porosity is 15%-25%; the pore size of the medium-density supporting section 2 is 370-450 μm, and the porosity is 27%-35%; and the pore size of the low-density connecting section 3 is 370-550 μm, and the porosity is 37%-45%.

[0136] Step (2): The prepared multi-filled porous titanium alloy bone plate structure framework is placed in a cavity mold, and then the cavity mold is filled with polyether ether ketone powder. The filling method is multiple equal filling. After each filling is completed, the polyether ether ketone powder is uniformly filled into the filling pores 9 of the multi-filled porous titanium alloy bone plate structure framework by oscillation, and the oscillation is mechanical oscillation or ultrasonic oscillation. The oscillation time is 22-39 min.

[0137] The difference between ultrasonic oscillation and mechanical oscillation is that the uniformity of ultrasonic oscillation is higher than that of mechanical oscillation. When the mixing precision requirement is high, ultrasonic oscillation is usually used, and mechanical oscillation is used instead.

[0138] After uniform filling, the mixed material is pressurized and formed through a cavity mold, the pressurized forming mode is vacuum hot isostatic pressing or vacuum cold isostatic pressing, the pressurized pressure is 150 MPa-260 MPa, the pressure maintaining time is 16 min-26 min, after pressurized forming, the gradual bone plate semi-finished product is obtained.

[0139] Step (3): The gradual bone plate forming material is placed in a high-temperature oven for sintering, the sintering mode is hot-pressing sintering, vacuum hot isostatic pressing sintering, gas pressure sintering, microwave sintering, discharge plasma sintering or solid-state metal sintering, the sintering temperature is 280℃-420℃, the sintering time is 1.6 h-2.4 h, after sintering, the high-strength gradual bone plate is obtained.

[0140] In Example 3, the particle size of the titanium alloy powder in step (1) is 100 μm, and the particle size of the polyether ether ketone powder is 200 μm.

[0141] The pore diameter of the high-density reinforcing section 1 in step (1) is 300 μm, and the porosity is 20%, the pore diameter of the medium-density supporting section 2 is 400 μm, and the porosity is 30%, the pore diameter of the low-density connecting section 3 is 500 μm, and the porosity is 40%.

[0142] The oscillation mode in step (2) is ultrasonic oscillation, and the oscillation time is 30 min.

[0143] The pressurized forming mode in step (2) is vacuum hot isostatic pressing, the pressurized pressure is 200 MPa, and the pressure maintaining time is 20 min.

[0144] The sintering mode in step (3) is vacuum hot isostatic pressing sintering, the sintering temperature is 350℃, and the sintering time is 2 h.

[0145] Example 4

[0146] When the reinforcing material is a degradable zinc alloy wire and the matrix material is polyether ether ketone powder, the preparation method comprises the following steps:

[0147] Step (1): The degradable zinc alloy wire is prepared into a multi-filled-pore degradable zinc alloy bone plate structure skeleton, and the preparation mode is wire weaving.

[0148] The diameter of the degradable zinc alloy wire is 520 μm-620 μm, and the particle size of the polyether ether ketone powder is 400 μm-520 μm.

[0149] The pore diameter of the high-density reinforcing section 1 of the multi-filled-pore degradable zinc alloy bone plate structural framework is 250-350 μm, the porosity is 15-25%, the pore diameter of the medium-density supporting section 2 is 370-450 μm, the porosity is 27-35%, and the pore diameter of the low-density connecting section 3 is 370-550 μm, the porosity is 37-45%.

[0150] Step (2): Put the prepared multi-filled-pore degradable zinc alloy bone plate structural framework into the cavity mold, then fill polyether ether ketone powder in the cavity mold, and adopt multiple equal filling, after each filling, uniformly fill the polyether ether ketone powder into the filling pores 9 of the multi-porous zinc alloy bone plate structural framework through oscillation, the oscillation mode is mechanical oscillation or ultrasonic oscillation, the oscillation time is 22-32 min, and after uniform filling, the mixed material is pressurized and formed through the cavity mold, the pressurized forming mode is vacuum hot isostatic pressing or vacuum cold isostatic pressing, the pressure is 80-110 MPa, the pressure holding time is 12-18 min, and after pressurized forming, a gradual bone plate semi-finished product is obtained.

[0151] Step (3): Put the gradual bone plate semi-finished product into a high-temperature oven for sintering, the sintering mode is hot-pressing sintering, vacuum hot isostatic sintering, gas pressure sintering, microwave sintering, discharge plasma sintering or solid-state metal sintering, the sintering temperature is 330-385℃, the sintering time is 0.8-1.2 h, and after sintering, a high-strength degradable gradual bone plate is obtained.

[0152] In Example 4, the diameter of the degradable zinc alloy wire in step (1) is 560 μm, and the particle size of the polyether ether ketone powder is 450 μm.

[0153] The pore diameter of the high-density reinforcing section 1 in step (1) is 300 μm, and the porosity is 20%, the pore diameter of the medium-density supporting section 2 is 400 μm, and the porosity is 30%, and the pore diameter of the low-density connecting section 3 is 500 μm, and the porosity is 40%.

[0154] The oscillation mode in step (2) is ultrasonic oscillation, and the oscillation time is 30 min.

[0155] The pressurized forming mode in step (2) is vacuum cold isostatic pressing, the pressure is 100 MPa, and the pressure holding time is 15 min.

[0156] The sintering mode in step (3) is hot-pressing sintering, the sintering temperature is 350℃, and the sintering time is 1 h.

[0157] Example 5

[0158] When the reinforcing material is a degradable magnesium alloy wire and the matrix material is polyether ether ketone powder, the preparation method comprises the following steps:

[0159] Step (1): The degradable magnesium alloy wire is prepared into a multi-filled-pore degradable magnesium alloy bone plate structure framework by weaving.

[0160] The diameter of the degradable magnesium alloy wire is 580 μm-720 μm, and the particle size of the polyether ether ketone powder is 430 μm-590 μm.

[0161] The pore diameter of the high-density reinforcing section 1 on the multi-filled-pore degradable magnesium alloy bone plate structure framework is 250 μm-350 μm, and the porosity is 15%-25%; the pore diameter of the medium-density supporting section 2 is 370 μm-450 μm, and the porosity is 27%-35%; and the pore diameter of the low-density connecting section 3 is 370-550 μm, and the porosity is 37%-45%.

[0162] Step (2): The prepared multi-filled-pore degradable magnesium alloy bone plate structure framework is placed in a cavity mold, and then the cavity mold is filled with polyether ether ketone powder. The filling is performed in multiple equal fillings. After each filling, the polyether ether ketone powder is uniformly filled into the filling pores 9 of the multi-pore magnesium alloy bone plate structure framework by means of oscillation, such as mechanical oscillation or ultrasonic oscillation. The oscillation time is 26 min-33 min. After uniform filling, the mixed material is press-formed by the cavity mold. The press-forming is performed by vacuum hot isostatic pressing or vacuum cold isostatic pressing. The pressure is 120 MPa-190 MPa. The pressure holding time is 3 min-9 min. After press-forming, a gradual bone plate semi-finished product is obtained.

[0163] Step (3): The gradual bone plate semi-finished product is placed in a high-temperature oven for sintering. The sintering is performed by hot-press sintering, vacuum hot isostatic sintering, gas pressure sintering, microwave sintering, discharge plasma sintering, or solid-state metal sintering. The sintering temperature is 280℃-420℃, and the sintering time is 0.6h-1.2h. After sintering, a high-strength degradable gradual bone plate is obtained.

[0164] In Example 5, the diameter of the degradable magnesium alloy wire in step (1) is 680 μm, and the particle size of the polyether ether ketone powder is 500 μm.

[0165] The pore diameter of the high-density reinforcing section 1 in step (1) is 300 μm, and the porosity is 20%. The pore diameter of the medium-density supporting section 2 is 400 μm, and the porosity is 30%. The pore diameter of the low-density connecting section 3 is 500 μm, and the porosity is 40%.

[0166] In step (2), the oscillation is ultrasonic oscillation, and the oscillation time is 30 min.

[0167] The pressurized forming in step (2) is vacuum hot isostatic pressing forming, the pressurized pressure is 150 MPa, and the pressure maintaining time is 5 min.

[0168] The sintering in step (3) is solid metal sintering, the sintering temperature is 330 DEG C, and the sintering time is 1 h.

[0169] The preparation of the reinforced material into a multi-filled pore bone plate structure framework in a progressive structure form by using a 3D printing method or a wire weaving method belongs to integrated three-dimensional processing, the structure is stable, the compressive strength is high, and the technical problems that the reinforced material in the existing bone plate is uniformly distributed in the polyether ether ketone matrix in the form of a prepreg tape, the interface bonding force is low, and when applied to a part of the human body that bears a high load, the bone plate is prone to breakage, delamination and other technical problems.

[0170] The preparation process of the bone plate, by using ordinary medical metal materials, high molecular fiber materials or degradable metal materials to prepare a multi-filled pore bone plate structure framework, then uniformly filling and mixing the multi-filled pore bone plate structure framework and the matrix material by ultrasonic oscillation, mixing, then forming by isostatic pressing, and finally putting the formed material into a high temperature oven for sintering.

[0171] It can be seen that each step can increase the strength of the bone plate, and after the completion of the overall steps, the strength of the bone plate is obviously enhanced, so that the bone plate can bear a high load impact force when in use, and a series of quality problems such as damage and fragmentation of the bone plate during use are avoided to the greatest extent, greatly improving the overall mechanical properties of the bone plate and ensuring that the bone plate can be used stably for a long time.

[0172] Moreover, by using degradable metal materials as reinforced materials, the bone plate product prepared by the preparation method has obvious bone induction ability, specifically, the degradable metal materials used in the bone plate product, such as degradable zinc alloy and degradable magnesium alloy, will react with the body fluid in the human body, and the reaction will produce Mg ions and Zn ions, which can promote bone regeneration through three main strategies, including balancing osteoblasts and osteoclasts, regulating immune microenvironment and promoting bone angiogenesis, and finally achieving the effect of bone induction.

[0173] More importantly, the bone plate prepared by using the preparation method is prepared by mixing different kinds of reinforcing materials and matrix materials, such as degradable metal wire or degradable metal powder, each reinforcing material and the corresponding matrix material has its fixed preparation parameter value, such as the diameter of the reinforcing material, the particle size, the particle size of the matrix material, and the pore size and porosity of the different density sections in the prepared multi-filled pore bone plate structure framework.

[0174] The selected reinforcing material and matrix material are uniformly mixed, pressure formed, sintered and the like to obtain the high-strength progressive bone plate, and the preparation process has strict, specific preparation parameters and preparation processes, such as the pressure forming method, the sintering method in the sintering process, the sintering temperature and the sintering time, and the like, which are the key to preparing the high-strength progressive bone plate material finished product.

[0175] Secondly, the high-strength progressive bone plate is prepared by using degradable metal materials and medical plastics, compared with the traditional bone plate prepared by using metal materials, the overall weight is lighter, which can significantly reduce the bone loss of patients, avoid a series of chain symptoms such as osteoporosis and calcification of bone.

[0176] The above is only a specific embodiment of the present application, which cannot limit the scope of the present application, so the replacement of equivalent components or equivalent changes and modifications made in the scope of the patent protection of the present application should still belong to the scope covered by the claims of the present application.

Claims

1. A high-strength progressive bone plate, characterized by: A multi-filled pore bone plate structure skeleton is provided, the multi-filled pore bone plate structure skeleton includes a high-density reinforcement section, a medium-density support section and a low-density connection section, the high-density reinforcement section is located in the middle of the multi-filled pore bone plate structure skeleton, the medium-density support section is located on both sides of the high-density reinforcement section, and the low-density connection section is located on the outside of the medium-density support section; The multi-filling pore bone plate structure skeleton is formed by interweaving silk threads, the density of the interwoven silk threads is unevenly distributed, and filling pores are formed between the interwoven silk threads, and the sizes of the filling pores are also unevenly distributed; The density of the interwoven threads on the multi-filled pore bone plate structure skeleton changes gradually, and the density of the interwoven threads on the multi-filled pore bone plate structure skeleton decreases gradually along the direction of the high-density reinforcement section, the medium-density support section and the low-density connection section; The size of the filled pores on the multi-filled pore bone plate structure skeleton also changes gradually, and the size of the filled pores increases gradually along the direction of the high-density reinforcement section, the medium-density support section and the low-density connection section; The filling pores are filled with polymer materials, and the exterior of the multi-filling pore bone fracture plate structure skeleton is coated with a layer of polymer materials; The multi-filled pore bone fracture plate structure skeleton is provided with a plurality of fixing holes, and the plurality of fixing holes penetrate through the polymer material coated on the exterior of the multi-filled pore bone fracture plate structure skeleton; A concave arc surface is provided on one side of the bone plate.

2. The high-strength progressive bone plate according to claim 1, characterized in that: The filling pores on the high-density reinforcement section are small square filling pores; The filling pores located in the middle of the medium-density support section are small square filling pores, and the filling pores located at the upper and lower sides of the medium-density support section are rectangular filling pores; The filling pores located in the middle of the low-density connecting section are small square filling pores, and the filling pores located at the upper and lower sides of the low-density connecting section are wide square filling pores; The width of the small square filled pores located in the middle of the low-density connecting section is smaller than the width of the small square filled pores located in the middle of the medium-density supporting section.

3. The high-strength progressive bone plate according to claim 1, characterized in that: There are six fixing holes. One fixing hole is provided near the left and right sides of the high-density reinforcement section, and one fixing hole is provided in the middle and near the outer sides of the two medium-density support sections.

4. The high-strength progressive bone plate according to claim 1, characterized in that: The outer surfaces of the bone plates are smoothly transitioned through rounded corners.

5. A method for preparing the high-strength progressive bone plate according to any one of claims 1 to 4, characterized in that: Prepare a reinforcement material and a matrix material, wherein the reinforcement material is a polymer fiber material or a metal material, and the matrix material is a polymer material. The preparation method includes the following steps: Step (1): preparing the reinforcement material into a multi-filled pore bone plate structure skeleton; Step (2): placing the prepared multi-filled pore bone plate structure skeleton and polymer material into the cavity mold respectively, and uniformly filling the polymer material into the filled pores of the multi-filled pore bone plate structure skeleton by an oscillation method, and then press-molding the uniformly mixed materials through the cavity mold to obtain a progressive bone plate semi-finished product after press-molding; Step (3): placing the semi-finished product of the progressive bone fracture plate into a high-temperature oven for sintering. After sintering, a high-strength progressive bone fracture plate is obtained.

6. The method for preparing a high-strength progressive bone plate according to claim 5, characterized in that: When the reinforcement material is titanium alloy wire and the matrix material is polyetheretherketone powder, the preparation method comprises the following steps: Step (1): preparing titanium alloy wires into a multi-filled pore titanium alloy bone plate structure skeleton by wire weaving; The diameter of the titanium alloy wire is 460 μm-520 μm, and the particle size of the polyetheretherketone powder is 350 μm-440 μm; The high-density reinforcement section on the multi-filled porous titanium alloy bone plate structure skeleton has a pore size of 250 μm-350 μm and a porosity of 15%-25%, the medium-density support section has a pore size of 370 μm-450 μm and a porosity of 27%-35%, and the low-density connection section has a pore size of 370-550 μm and a porosity of 37%-45%; Step (2): placing the prepared multi-filled pore titanium alloy bone plate structural skeleton into a cavity mold, and then filling the cavity mold with polyetheretherketone powder, the filling method adopts multiple equal fillings, after each filling is completed, the polyetheretherketone powder is evenly filled into the filling pores of the multi-filled pore titanium alloy bone plate structural skeleton by shaking, the shaking method is mechanical shaking or ultrasonic shaking, the shaking time is 26min-33min, after uniform filling, the mixed material is press-formed by the cavity mold, the press-forming method is vacuum hot isostatic pressing or vacuum cold isostatic pressing, the pressurizing pressure is 150MPa-220MPa, the pressure holding time is 24min-38min, after press-forming, a progressive bone plate semi-finished product is obtained; Step (3): placing the semi-finished product of the progressive bone plate into a high-temperature oven for sintering, wherein the sintering method is hot pressing sintering, vacuum hot isostatic pressing sintering, gas pressure sintering, microwave sintering, spark plasma sintering or solid metal sintering, the sintering temperature is 305°C-386°C, and the sintering time is 1.1h-1.7h. After sintering, a high-strength progressive bone plate is obtained.

7. The method for preparing a high-strength progressive bone plate according to claim 5, characterized in that: When the reinforcement material is carbon fiber filaments and the matrix material is polyetheretherketone powder, the preparation method comprises the following steps: Step (1): preparing a carbon fiber wire into a multi-filled pore carbon fiber bone plate structure skeleton by weaving the wire; The diameter of the carbon fiber filament is 8 μm-13 μm, the number of monofilaments is 6K-12K, and the particle size of the polyetheretherketone powder is 20 μm-29 μm; The high-density reinforcement section on the multi-filled pore carbon fiber bone plate structural skeleton has a pore size of 250 μm-350 μm and a porosity of 15%-25%, the medium-density support section has a pore size of 370 μm-450 μm and a porosity of 27%-35%, and the low-density connection section has a pore size of 370-550 μm and a porosity of 37%-45%; Step (2): placing the prepared multi-filled pore carbon fiber bone plate structure skeleton into a cavity mold, and then filling the cavity mold with polyetheretherketone powder, the filling method adopts multiple equal fillings, after each filling is completed, the polyetheretherketone powder is evenly filled into the filling pores of the multi-filled pore carbon fiber bone plate structure skeleton by shaking, the shaking method is mechanical shaking or ultrasonic shaking, the shaking time is 26min-33min, after uniform filling, the mixed material is press-formed by the cavity mold, the press-forming method is vacuum hot isostatic pressing or vacuum cold isostatic pressing, the press pressure is 110MPa-190MPa, the pressure holding time is 22min-28min, after press-forming, a progressive bone plate semi-finished product is obtained; Step (3): placing the semi-finished product of the progressive bone plate into a high-temperature oven for sintering, wherein the sintering method is hot pressing sintering, vacuum hot isostatic pressing sintering, gas pressure sintering, microwave sintering, spark plasma sintering or solid metal sintering, the sintering temperature is 305°C-365°C, and the sintering time is 0.6h-1.2h. After sintering, a high-strength progressive bone plate is obtained.

8. The method for preparing a high-strength progressive bone plate according to claim 6, characterized in that: The diameter of the titanium alloy wire in step (1) is 500 μm, and the particle size of the polyetheretherketone powder is 400 μm; The high-density reinforcement segment in step (1) has a pore size of 300 μm and a porosity of 20%, the medium-density support segment has a pore size of 400 μm and a porosity of 30%, and the low-density connection segment has a pore size of 500 μm and a porosity of 40%; The oscillation method in step (2) is ultrasonic oscillation, and the oscillation time is 30 minutes; The press forming method in step (2) is vacuum hot isostatic pressing, the press pressure is 200 MPa, and the holding time is 30 minutes; The sintering method in step (3) is vacuum hot isostatic pressing sintering, the sintering temperature is 345° C., and the sintering time is 1.5 h.

9. The method for preparing a high-strength progressive bone plate according to claim 7, characterized in that: The diameter of the carbon fiber filament in step (1) is 10 μm, the number of monofilaments is 10K, and the particle size of the polyetheretherketone powder is 25 μm; The high-density reinforcement segment in step (1) has a pore size of 300 μm and a porosity of 20%, the medium-density support segment has a pore size of 400 μm and a porosity of 30%, and the low-density connection segment has a pore size of 500 μm and a porosity of 40%; The oscillation method in step (2) is ultrasonic oscillation, and the oscillation time is 30 minutes; The pressurizing method in step (2) is vacuum cold isostatic pressing, the pressurizing pressure is 160 MPa, and the holding time is 25 minutes; The sintering method in step (3) is spark plasma sintering, the sintering temperature is 343° C., and the sintering time is 1 hour.

10. The method for preparing a high-strength progressive bone plate according to claim 5, characterized in that: The reinforcement material may also be a degradable metal material.

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