Osteoinductive high strength intervertebral fusion cage and method of making

Abstract

The application provides a high-strength intervertebral fusion cage with bone induction and a preparation method, and the preparation method comprises the following steps: preparing a reinforcing material and a base material, preparing a degradable metal material into a multi-filled intervertebral fusion cage framework, respectively placing the prepared multi-filled intervertebral fusion cage framework and the base material into a cavity mold for mixing and filling, then pressing the uniformly mixed material through the cavity mold, placing the intervertebral fusion cage forming material into a high-temperature oven for sintering, and obtaining the high-strength intervertebral fusion cage with bone induction. The application solves the technical problems that the current lumbar interbody fusion cage is prepared by using titanium alloy material, causing stress shielding, and the technical problems that the intervertebral fusion cage is prepared by using polyether ether ketone or carbon fiber reinforced polyether ether ketone material, and the material lacks bioactivity, which is not conducive to bone fusion, and causes the technical problems that the intervertebral fusion cage sinks and loosens after being implanted. The application can be widely applied to the preparation of intervertebral fusion cages.

Description

TECHNICAL FIELD

[0001] The present application relates to an intervertebral fusion cage, in particular to an intervertebral fusion cage with high strength and bone induction and a preparation method. BACKGROUND

[0002] The intervertebral fusion cage is a surgical instrument commonly used in lumbar surgery, which is used for the treatment of lumbar disc herniation, spondylolisthesis and other diseases.

[0003] At present, most intervertebral fusion cages are prepared from titanium alloy, polyether ether ketone or carbon fiber reinforced polyether ether ketone material, but the elastic modulus of titanium alloy is much larger than that of human natural bone, which will cause stress shielding due to the difference, and the elastic modulus of polyether ether ketone or carbon fiber reinforced polyether ether ketone material is close to that of human bone, but polyether ether ketone and carbon fiber reinforced polyether ether ketone material lack biological activity, which is not conducive to bone fusion, resulting in problems such as subsidence and loosening after implantation of the intervertebral fusion cage. SUMMARY

[0004] The present application provides an intervertebral fusion cage with high strength and bone induction and a preparation method, which uses degradable metal material as reinforcing material and mixes with the matrix material to prepare, and the degradable metal material in the intervertebral fusion cage will react with body fluid in the body and gradually be corroded and degraded by the body fluid after implantation.

[0005] Specifically, the degradable zinc alloy material and the degradable magnesium alloy material will produce magnesium ions or zinc ions when reacting with the body fluid, and these two ions are the most important trace elements in bone tissue and indispensable active ingredients in human biological activities, which play an important role in bone tissue repair and can effectively accelerate the fusion speed and effect of bone injury site, promote the recovery of bone injury site, ensure the long-term stable use of lumbar fusion cage implant, and effectively avoid the problems such as subsidence and loosening after implantation of the intervertebral fusion cage.

[0006] In addition, the elastic modulus of the degradable zinc alloy material and the degradable magnesium alloy material is low, which can avoid the problem of stress shielding effect caused by high elastic modulus of traditional metal materials.

[0007] Therefore, the technical scheme of the present application is an intervertebral fusion cage with high strength and bone induction, which is provided with a multi-pore metal intervertebral fusion cage framework formed by interweaving wires, and the wires are made of degradable metal material.

[0008] The high polymer material is filled in the filling hole, and the outer part of the multi-filled hole metal intervertebral fusion cage framework is coated with a layer of high polymer material;

[0009] The multi-filled hole metal intervertebral fusion cage framework comprises a front end vertebral part and a rear end support fusion part, the front end vertebral part is of a vertebral structure, and the rear end of the rear end support fusion part is provided with a clamping groove, the clamping groove penetrating through the high polymer material coated on the outer part of the multi-filled hole metal intervertebral fusion cage framework;

[0010] The degradable metal material in the intervertebral fusion cage leaves a porous structure plastic after degradation, and the bone tissue generated by the stimulation of metal ions can grow into the pores of the porous structure plastic.

[0011] Preferably, the upper end and the lower end of the rear end support fusion part are respectively provided with outwardly protruding fixing racks, the fixing racks are arranged along the length direction of the multi-filled hole metal intervertebral fusion cage framework, and the height of the fixing rack is 0.3 mm±0.02 mm.

[0012] Preferably, the upper end and the lower end of the rear end support fusion part are respectively provided with outwardly protruding fixing racks, the fixing racks are arranged along the length direction of the multi-filled hole metal intervertebral fusion cage framework, and the height of the fixing rack is 0.3 mm±0.02 mm.

[0013] Preferably, the upper end and the lower end of the rear end support fusion part are respectively provided with outwardly protruding fixing racks, the fixing racks are arranged along the length direction of the multi-filled hole metal intervertebral fusion cage framework, and the height of the fixing rack is 0.3 mm±0.02 mm.

[0014] The upper and lower penetrating bone tissue filling holes and the left and right penetrating bone tissue filling holes penetrate through the high polymer material coated on the outer part of the multi-filled hole metal intervertebral fusion cage framework.

[0015] Preferably, the shape of the upper and lower penetrating bone tissue filling holes is strip-shaped, and the shape of the left and right penetrating bone tissue filling holes is circular.

[0016] The length of the strip-shaped bone tissue filling hole is smaller than the length of the fixing rack, and the width of the strip-shaped bone tissue filling hole is smaller than the width of the fixing rack.

[0017] The diameter of the circular bone tissue filling hole is not greater than 1 / 4 of the thickness of the rear end support fusion part.

[0018] Preferably, the outer surface of the intervertebral fusion cage is smoothly transitioned through a round corner.

[0019] A preparation method of the above-mentioned intervertebral fusion cage with bone induction and high strength, the preparation method comprises the following steps:

[0020] Step (1): preparing the degradable metal material into a multi-filled hole metal intervertebral fusion cage framework;

[0021] Step (2): Put the prepared multi-filled porous metal intervertebral fusion cage skeleton and high polymer material into the cavity mold respectively, and use the oscillation method to uniformly fill the high polymer material into the filling pores of the multi-filled porous metal intervertebral fusion cage skeleton, then pressurize the uniformly mixed material through the cavity mold, and after pressurization, a semi-finished intervertebral fusion cage is obtained;

[0022] Step (3): Put the intervertebral fusion cage forming material into a high-temperature oven for sintering, and after sintering, a high-strength intervertebral fusion cage with bone induction is obtained.

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

[0024] Step (1): Prepare a multi-filled porous magnesium alloy intervertebral fusion cage skeleton from degradable magnesium alloy powder by 3D printing method;

[0025] The particle size of the degradable magnesium alloy powder is 35-85 μm, the particle size of the polyether ether ketone powder is 10-50 μm, the thickness of the multi-filled porous magnesium alloy intervertebral fusion cage skeleton is 8-12 mm, the pore size is 300-500 μm, and the porosity is 40-70%;

[0026] Step (2): Put the prepared multi-filled porous magnesium alloy intervertebral fusion cage skeleton into the cavity mold, then fill the polyether ether ketone powder in the cavity mold, and use the multiple equal filling method, with three times of filling. After each filling, uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage skeleton by ultrasonic oscillation for 25-40 min. After uniform filling, pressurize the mixed material through the cavity mold, and use the isostatic pressing method for pressurization, with a pressure of 35-75 MPa and a pressure holding time of 5-20 min. After pressurization, a semi-finished intervertebral fusion cage is obtained;

[0027] Step (3): Put the intervertebral fusion cage forming material into a high-temperature oven for sintering, and after sintering, a high-strength intervertebral fusion cage with bone induction is obtained.

[0028] Preferably, the particle size of the degradable magnesium alloy powder in step (1) is 50 μm, the particle size of the polyether ether ketone powder is 20 μm, the thickness of the multi-filled porous magnesium alloy intervertebral fusion cage skeleton is 10 mm, the pore size is 400 μm, and the porosity is 60%;

[0029] The ultrasonic vibration time in step (2) is 30 min, the pressurization pressure is 50 MPa, and the pressure maintaining time is 10 min.

[0030] The sintering mode in step (3) is hot isostatic pressing sintering, the sintering temperature is 330 ℃, and the sintering time is 1 h.

[0031] Preferably, when the reinforcing material is a degradable zinc alloy wire and the matrix material is an ultra-high molecular weight polyethylene powder, the preparation method comprises the following steps:

[0032] Step (1): The degradable zinc alloy wire is prepared into a multi-filled porosity zinc alloy intervertebral fusion cage framework by a wire weaving method.

[0033] The diameter of the degradable zinc alloy wire is 400 μm-650 μm, the particle size of the ultra-high molecular weight polyethylene powder is 700 μm-950 μm, the thickness of the multi-filled porosity zinc alloy intervertebral fusion cage framework is 6 mm-10 mm, the pore size is 400 μm-650 μm, and the porosity is 70%-85%.

[0034] Step (2): The prepared multi-filled porosity zinc alloy intervertebral fusion cage framework is placed in a cavity mold, then the cavity mold is filled with the ultra-high molecular weight polyethylene powder, the filling is performed by multiple equal fillings, the filling is performed five times, after each filling, the ultra-high molecular weight polyethylene powder is uniformly filled into the filling pores of the multi-filled porosity zinc alloy intervertebral fusion cage framework by ultrasonic vibration, the ultrasonic vibration time is 45 min-65 min, after uniform filling, the mixed material is pressurized and formed by isostatic pressing through the cavity mold, the pressurization pressure is 100 MPa-260 MPa, the pressure maintaining time is 20 min-45 min, after pressurization and forming, an intervertebral fusion cage semi-finished product is obtained.

[0035] Step (3): The intervertebral fusion cage forming material is placed in a high-temperature oven for sintering, the sintering mode is hot pressing sintering, hot isostatic pressing sintering, gas pressure sintering, microwave sintering or discharge plasma sintering, the sintering temperature is 200 ℃-460 ℃, and the sintering time is 0.8 h-2.3 h, after sintering, a bone-inducing high-strength intervertebral fusion cage is obtained.

[0036] Preferably, the diameter of the degradable zinc alloy wire in step (1) is 500 μm, the particle size of the ultra-high molecular weight polyethylene powder is 800 μm, the thickness of the multi-filled porosity zinc alloy intervertebral fusion cage framework is 8 mm, the pore size is 500 μm, and the porosity is 80%.

[0037] The ultrasonic vibration time in step (2) is 60 min, the pressurization pressure is 180 MPa, and the pressure maintaining time is 30 min.

[0038] The sintering mode in step (3) is hot isostatic sintering, the sintering temperature is 345℃, and the sintering time is 1.5h.

[0039] The beneficial effects of the present application are:

[0040] 1. The intervertebral fusion cage prepared by the preparation method of the intervertebral fusion cage is prepared by using a degradable metal material to prepare a multi-filled intervertebral fusion cage framework, and then the multi-filled intervertebral fusion cage framework is uniformly mixed and filled with a base material by ultrasonic oscillation, and after mixing, it is formed by isostatic pressing, and finally the formed material is placed in a high-temperature oven for sintering, wherein each step can increase the strength of the intervertebral fusion cage implant, and after the overall steps are completed, the strength of the intervertebral fusion cage implant is significantly enhanced, so that the intervertebral fusion cage implant can withstand high load impact force when in use, and a series of quality problems such as damage and fragmentation of the intervertebral fusion cage implant after implantation are avoided to the greatest extent, greatly improving the overall mechanical properties of the intervertebral fusion cage implant and ensuring that the intervertebral fusion cage implant can be used stably for a long time.

[0041] 2. The intervertebral fusion cage is prepared by mixing degradable zinc alloy material or degradable magnesium alloy material with high molecular material, and the degradable zinc alloy material and the degradable magnesium alloy material will produce magnesium ions or zinc ions when reacting with body fluid. 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. Moreover, magnesium ions or zinc ions can promote bone regeneration through three main strategies, including balancing osteoblasts and osteoclasts, regulating immune microenvironment, and promoting bone angiogenesis, ultimately achieving bone induction effect, thereby accelerating the bone healing speed.

[0042] 3. The intervertebral fusion cage implant is prepared by mixing degradable metal material and medical plastic, which has a lighter overall weight compared to traditional metal materials, thereby significantly reducing bone loss in patients and avoiding a series of linked symptoms such as osteoporosis and calcification of bone mass.

[0043] 4. By setting the fixed rack on the intervertebral fusion cage, during the operation, the doctor places the intervertebral fusion cage at the specified position between the vertebrae, at this time, the fixed racks on both sides are effectively clamped with the upper and lower end plates, thereby tightly embedding the intervertebral fusion cage with the upper and lower vertebrae, effectively increasing the stability of the upper and lower vertebrae and the intervertebral fusion cage, further avoiding the displacement and regression of the intervertebral fusion cage, providing a stable mechanical environment for bone fusion, and ensuring that the implant can be used stably for a long time.

[0044] Secondly, the tooth edge of the fixed rack is arranged as an arc surface structure, which can avoid damage to the upper and lower vertebral bodies during implantation due to the too sharp tooth edge. BRIEF DESCRIPTION OF DRAWINGS

[0045] Fig. 1 is a finished product structure perspective view of the present application;

[0046] Fig. 2 is another finished product structure perspective view of the present application

[0047] Fig. 3 is a finished product structure perspective view of the present application;

[0048] Explanation of symbols in the drawings:

[0049] 1. anterior vertebral portion; 2. posterior support fusion portion; 3. fixed rack; 4. bone tissue filling hole; 5. clamping groove; 6. multi-filling hole metal intervertebral fusion cage framework; 7. filling hole; 8. wire; 9. rounded corner. DETAILED DESCRIPTION

[0050] The present application will be further described below in conjunction with examples.

[0051] Through Figs. 1-3 As can be seen, the intervertebral fusion cage with high strength and bone induction has a multi-filling hole metal intervertebral fusion cage framework 6 formed by interweaving wires 8, and filling holes 7 are formed between the interweaved wires 8, and the wires 8 are made of degradable metal materials.

[0052] The filling holes 7 are filled with high molecular materials, and the multi-filling hole metal intervertebral fusion cage framework 6 is coated with a layer of high molecular materials on the outside.

[0053] The multi-filling hole metal intervertebral fusion cage framework 6 includes an anterior vertebral portion 1 and a posterior support fusion portion 2, the anterior vertebral portion 1 is of a vertebral structure, and the posterior support fusion portion 2 is provided with a clamping groove 5 at the rear end, and the clamping groove 5 penetrates through the high molecular materials coated on the outside of the multi-filling hole metal intervertebral fusion cage framework 6.

[0054] The design of the clamping groove 5 can facilitate the doctor to clamp the intervertebral fusion cage during the operation, and the operation is convenient and fast.

[0055] The anterior vertebral portion 1 of the vertebral structure can avoid damage to the cone endplate when the intervertebral fusion cage is inserted, and can maximize the integrity of the vertebral endplate structure.

[0056] The upper end and the lower end of the posterior support fusion portion 2 are respectively provided with outwardly protruding fixed racks 3, and the fixed racks 3 are arranged along the length direction of the multi-filling hole metal intervertebral fusion cage framework 6.

[0057] By setting the fixed rack 3, during the operation, after the doctor places the intervertebral fusion cage to the designated position between the vertebrae, at this time, the two sides of the fixed rack 3 are clamped with the upper and lower end plates respectively, so as to tightly insert the intervertebral fusion cage with the upper and lower vertebral bodies, effectively increase the stability of the fixation of the upper and lower vertebral bodies and the intervertebral fusion cage, further avoid the problems of displacement and backout of the intervertebral fusion cage, provide a stable mechanical environment for bone grafting, and ensure that the implant can be used stably for a long time.

[0058] The height of the fixed rack 3 is 0.3mm±0.02mm, if the height of the fixed rack 3 is too high, after implantation, it will cause the teeth to be embedded in the end plate or cancellous bone part to a depth, which is easy to cause the risk of cone collapse, if the height of the fixed rack 3 is too low, the function of setting the fixed rack is lost, and the effect of embedding the intervertebral fusion cage with the upper and lower vertebral bodies is reduced.

[0059] Secondly, the tooth edge of the fixed rack 3 is set as an arc surface structure, which can avoid damage to the upper and lower vertebral bodies due to the too sharp tooth edge.

[0060] The upper and lower through bone tissue filling holes 4 are provided on the position of the fixed rack 3 on the rear end support fusion part 2.

[0061] The left and right through bone tissue filling holes 4 are provided on the rear end support fusion part 2, and the left and right through bone tissue filling holes 4 simultaneously pass through the upper and lower through bone tissue filling holes 4 on the rear end support fusion part 2.

[0062] The shape of the upper and lower through bone tissue filling holes 4 is a long strip shape, and the shape of the left and right through bone tissue filling holes 4 is a circular shape.

[0063] The length of the long strip-shaped bone tissue filling hole 4 is less than the length of the fixed rack 3, and the width of the long strip-shaped bone tissue filling hole 4 is less than the width of the fixed rack 3.

[0064] If the length and width dimensions of the long strip-shaped bone tissue filling hole 4 exceed the length and width dimensions of the fixed rack 3, the continuity of the fixed rack 3 will be destroyed, which directly affects the locking effect of the fixed rack 3.

[0065] The diameter of the circular bone tissue filling hole 4 is not greater than 1 / 4 of the thickness of the rear end support fusion part 2.

[0066] The upper and lower through bone tissue filling holes 4 and the left and right through bone tissue filling holes 4 respectively pass through the high molecular material coated outside the multi-pore metal intervertebral fusion cage framework 6.

[0067] By setting the bone tissue filling hole 4, in the operation, the bone tissue filling hole is placed to the bone tissue filler, after the intervertebral fusion cage is implanted, the bone tissue filler in the bone tissue filling hole and the connected bone tissue realize preliminary fusion quickly, and the positioning and locking between the fixed rack 3 and the bone tissue can avoid the hidden danger that the intervertebral fusion cage is easily dislocated due to the failure to complete the preliminary fusion positioning between the intervertebral fusion cage and the bone tissue in the early stage after the intervertebral fusion surgery is completed, and can further increase the stability of the intervertebral fusion cage and the bone tissue during fusion. Compared with the method of increasing the stability between the intervertebral fusion cage and the bone tissue by the fixed rack 3 alone, the effect is better.

[0068] More importantly, for the shape and size of the up-and-down penetrating bone tissue filling hole 4 and the left-and-right penetrating bone tissue filling hole 4, both the fusion performance of the intervertebral fusion cage and the compression strength of the intervertebral fusion cage are ensured. If the size of the up-and-down penetrating bone tissue filling hole 4 and the left-and-right penetrating bone tissue filling hole 4 is too large, the position around the bone tissue filling hole 4 will be thinned, which directly affects the compression strength of the intervertebral fusion cage as a whole, and easily causes the problem of fracture of the intervertebral fusion cage.

[0069] The outer surface of the intervertebral fusion cage is smoothly transitioned through a round corner, which can avoid the outer surface of the intervertebral fusion cage being too sharp and causing harm to the connected bone tissue.

[0070] A preparation method of the above-mentioned intervertebral fusion cage with high strength and bone induction property, which prepares a reinforcing body material and a matrix material, the reinforcing body material is a degradable metal material, and the matrix material is a polymer material, and the preparation method comprises the following steps:

[0071] Step (1): The degradable metal material is prepared into a multi-filled hole metal intervertebral fusion cage framework 6.

[0072] Step (2): The prepared multi-filled hole metal intervertebral fusion cage framework 6 and the polymer material are respectively placed into a cavity mold, the polymer material is uniformly filled into the filling hole 7 of the multi-filled hole metal intervertebral fusion cage framework 6 by using a shaking method, and then the uniformly mixed material is subjected to pressure forming through the cavity mold. After pressure forming, an intervertebral fusion cage semi-finished product is obtained.

[0073] Step (3): The intervertebral fusion cage forming material is placed into a high-temperature oven for sintering. After sintering, an intervertebral fusion cage with high strength and bone induction property is obtained.

[0074] Example 1

[0075] When the reinforcing body material is a degradable magnesium alloy powder and the matrix material is a polyether ether ketone powder, the preparation method comprises the following steps:

[0076] Step (1): The degradable magnesium alloy powder is prepared into a multi-filled porous magnesium alloy intervertebral cage framework by 3D printing.

[0077] The particle size of the degradable magnesium alloy powder is 35-85 μm, the particle size of the polyether ether ketone powder is 10-50 μm, the thickness of the multi-filled porous magnesium alloy intervertebral cage framework is 8-12 mm, the pore size is 300-500 μm, and the porosity is 40-70%.

[0078] Step (2): The prepared multi-filled porous magnesium alloy intervertebral cage 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, and the filling frequency is three times. Multiple equal filling can ensure that the matrix material powder and the multi-filled porous metal intervertebral cage framework 6 are fully and uniformly filled, avoiding inconsistent density at different positions, which leads to low compression strength of the prosthesis, and even problems such as cracking and delamination of the prosthesis. The specific filling frequency of different materials is obtained through a large number of experiments, which can not only ensure the filling density of the prosthesis and the sufficient compression resistance of the prosthesis, but also save processing time.

[0079] After each filling is completed, the polyether ether ketone powder is uniformly filled into the filling pores 7 of the multi-filled porous magnesium alloy intervertebral cage framework through ultrasonic oscillation, and the ultrasonic oscillation time is 25-40 min. After uniform filling, the mixed material is press-formed by the cavity mold. The press-forming method is isostatic pressing. Isostatic pressing can ensure that the density of the compact is uniform and consistent, and the green body density is high. In addition, due to the high green body density, the sintering shrinkage is small during sintering, and the sintered body is not easy to deform, which ensures the structural stability of the embryo. Moreover, the green body strength is high, which can be directly transported and machined. More importantly, the green body has small internal stress, which reduces the defects such as cracking and delamination of the green body.

[0080] The pressure intensity is 35-75 MPa, and the pressure holding time is 5-20 min. After press-forming, an intervertebral cage semi-finished product is obtained.

[0081] Step (3): The intervertebral cage forming material is placed in a high-temperature oven for sintering. The sintering method is hot pressing sintering, hot isostatic pressing sintering, gas pressure sintering, microwave sintering or discharge plasma sintering. The sintering temperature is 250-350℃, and the sintering time is 1-3 h. After sintering, a high-strength intervertebral cage with bone induction is obtained.

[0082] In the formula, hot-pressing sintering refers to a sintering process in which a material is accelerated to flow, rearrange and densify under a certain external force (generally, the pressure is 10-40 MPa according to the strength of the mold material), the temperature required for hot-pressing sintering is 100-150 ℃ lower than that for normal-pressure sintering, but the driving force for hot-pressing sintering is 20-100 times greater than that for normal-pressure sintering.

[0083] Hot-pressing sintering can obtain better mechanical properties of the material, and can reduce the sintering time or the sintering temperature, and reduce the amount of covalent bond ceramic sintering aids, thereby improving the high-temperature mechanical properties of the material.

[0084] The basic principle of hot isostatic pressing sintering is to use high-pressure gas as a pressure medium to act on the material (including the enclosed powder, green body or sintered body), so that the material is subjected to balanced pressure in all directions during heating, and the material is densified by the combined action of high temperature and high pressure.

[0085] Hot isostatic pressing sintering can reduce the sintering temperature and shorten the sintering time, and at the same time, can greatly reduce or even not use sintering aids, thereby improving the ceramic performance and reliability, and is particularly suitable for manufacturing complex-shaped products.

[0086] Gas pressure sintering refers to the application of a certain gas pressure during high-temperature sintering, and the pressure range is usually 1-10 MPa, so as 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 a high-density product. Gas pressure sintering and vacuum hot isostatic pressing sintering both use gas as a pressure transmission method.

[0087] Compared with hot-pressing sintering and vacuum hot isostatic pressing sintering, the biggest advantage of gas pressure sintering is that it can reduce the investment cost, prepare products with good performance, is suitable for complex-shaped products, and can realize batch production.

[0088] Microwave sintering is commonly used for sintering of ceramic materials, which uses the dielectric loss of ceramic materials in a microwave electromagnetic field to achieve sintering and densification of the ceramic materials.

[0089] Discharge plasma sintering, also known as "plasma activated sintering", is a new material preparation technology which directly applies a large pulse current to the mold or sample to achieve material sintering through thermal effect or other field effect.

[0090] Discharge plasma sintering can ensure the uniformity of the heating temperature, has a fast heating speed, a low sintering temperature, a short sintering time, a high production efficiency, a small and uniform product organization, can maintain the natural state of the raw materials, and can obtain high-density materials, and is commonly used for sintering gradient materials and complex workpieces.

[0091] Solid state metal sintering is a sintering process that uses powdered materials that can be molded into the desired shape, producing parts with complex shapes and intricate designs, and that can improve the mechanical properties of the material. Compared to traditional processes, solid state sintering has a shorter cycle time, meaning that the sintering process can be completed in a few minutes instead of hours or more. This high productivity and rapid material development capability makes solid state metal sintering more widely used.

[0092] More importantly, solid state metal sintering can be performed at a lower temperature compared to traditional 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 parts, making it a very widely applicable process.

[0093] In summary, solid state metal sintering has several 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.

[0094] In Example 1, the particle size of the degradable magnesium alloy powder in step (1) was 50 μm, the particle size of the polyether ether ketone powder was 20 μm, the thickness of the multi-filled porous magnesium alloy intervertebral cage framework was 10 mm, the pore size was 400 μm, and the porosity was 60%.

[0095] The thickness of the intervertebral cage has strict standards. If the thickness is too thick, it will cause difficulty in implantation during surgery, excessive distraction of the intervertebral space, and even nerve root traction injury. In addition, due to the excessive thickness of the intervertebral cage, the stress of the adjacent segment increases, increasing the incidence of vertebral degeneration.

[0096] Furthermore, the excessive thickness of the intervertebral cage will also cause the problem of subsidence and migration after implantation of the intervertebral cage, resulting in the inability of the intervertebral cage to function normally for a long time.

[0097] If the thickness is too thin, there will be a gap between the intervertebral cage and the vertebral body after implantation of the intervertebral cage, the intervertebral cage cannot be effectively fixed, and the normal thickness and lordosis of the lumbar spine cannot be effectively restored, directly leading to the failure of the implant to eventually fuse.

[0098] The ultrasonic oscillation time in step (2) was 30 min, the pressure intensity was 50 MPa, and the pressure holding time was 10 min.

[0099] The sintering method in step (3) is hot isostatic sintering, the sintering temperature is 330°C, and the sintering time is 1h.

[0100] Example 2

[0101] When the reinforcing material is a degradable zinc alloy wire and the matrix material is an ultra-high molecular weight polyethylene powder, the preparation method comprises the following steps:

[0102] Step (1): The degradable zinc alloy wire is prepared into a multi-filled porosity zinc alloy intervertebral fusion cage framework by a wire weaving method.

[0103] The diameter of the degradable zinc alloy wire is 400μm-650μm, the particle size of the ultra-high molecular weight polyethylene powder is 700μm-950μm, the thickness of the multi-filled porosity zinc alloy intervertebral fusion cage framework is 6mm-10mm, the pore size is 400μm-650μm, and the porosity is 70%-85%.

[0104] Step (2): The prepared multi-filled porosity zinc alloy intervertebral fusion cage framework is placed in a cavity mold, then the cavity mold is filled with the ultra-high molecular weight polyethylene powder, the filling is performed in multiple equal times, the filling is performed five times, after each filling, the ultra-high molecular weight polyethylene powder is uniformly filled into the filling pores 7 of the multi-filled porosity zinc alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 45min-65min, after uniform filling, the mixed material is pressure formed by isostatic pressing through the cavity mold, the pressure intensity is 100MPa-260MPa, and the pressure holding time is 20min-45min, after pressure forming, an intervertebral fusion cage semi-finished product is obtained.

[0105] Step (3): The intervertebral fusion cage forming material is placed in a high-temperature oven for sintering, the sintering method is hot pressing sintering, hot isostatic sintering, gas pressure sintering, microwave sintering or discharge plasma sintering, the sintering temperature is 200°C-460°C, the sintering time is 0.8h-2.3h, and after sintering, a bone-inducing high-strength intervertebral fusion cage is obtained.

[0106] In example 1, the diameter of the degradable zinc alloy wire in step (1) is 500μm, the particle size of the ultra-high molecular weight polyethylene powder is 800μm, the thickness of the multi-filled porosity zinc alloy intervertebral fusion cage framework is 8mm, the pore size is 500μm, and the porosity is 80%.

[0107] The ultrasonic oscillation time in step (2) is 60min, the pressure intensity is 180MPa, and the pressure holding time is 30min.

[0108] The sintering mode in step (3) is hot isostatic sintering, the sintering temperature is 345℃, and the sintering time is 1.5h.

[0109] The degradable zinc alloy material and the degradable magnesium alloy material can react with body fluid in the human body, and gradually be corroded and degraded by the body fluid. Specifically, when the degradable zinc alloy material and the degradable magnesium alloy material react with the body fluid, magnesium ions or zinc ions are generated. These two ions are the most important trace elements in bone tissue and indispensable active components in human biological activities, and play an important role in bone tissue repair, which can effectively accelerate the fusion speed and effect of the bone injury site, and promote the fusion of the bone injury site.

[0110] The above-mentioned wire weaving method or 3D printing method, wherein the wire weaving method has lower cost, but has greater design limitations for a series of parameters of the porous metal material, and the 3D printing method has higher adjustability for the shape, size and porosity of the pores when preparing the porous metal material, and can be adjusted according to the imaging data of the patient to achieve the most suitable implantation effect. Therefore, when the requirement for the structure parameters of the prosthesis is high, the 3D printing is selected, and when the requirement for the structure parameters of the prosthesis is not high and cost saving is considered, the wire weaving is selected.

[0111] The osteoinductive intervertebral fusion cage implant is prepared by using a degradable metal material to form a multi-pore metal intervertebral fusion cage framework 6, then the multi-pore metal intervertebral fusion cage framework 6 is uniformly filled and mixed with the base material by ultrasonic oscillation, and then the mixed material is formed by isostatic pressing, and finally the formed material is placed in a high-temperature oven for sintering.

[0112] It can be seen that each step can increase the strength of the intervertebral fusion cage implant, and after the completion of the overall steps, the strength of the intervertebral fusion cage implant is obviously enhanced, so that the intervertebral fusion cage implant can withstand high load impact force when in use, and the intervertebral fusion cage implant can be prevented from being damaged, cracked and other quality problems when in use, thereby greatly improving the overall mechanical properties of the intervertebral fusion cage implant and ensuring that the intervertebral fusion cage implant can be used stably for a long time.

[0113] And the prepared intervertebral fusion cage product has obvious bone induction capacity, and the realization of the specific bone induction effect depends on two aspects, one is the degradable metal material used in the intervertebral fusion cage product, such as degradable zinc alloy and degradable magnesium alloy, which will react with the body fluid in the human body to produce Mg ions and Zn ions, and the two ions can promote bone regeneration through three main strategies, including balancing osteoblasts and osteoclasts, adjusting the immune microenvironment, and promoting bone angiogenesis, and finally realizing the bone induction effect.

[0114] The other is the porous plastic structure left after the degradation of the degradable metal material, such as polyether ether ketone or ultra-high molecular weight polyethylene product structure, and the pore size and porosity of the porous plastic structure are consistent with the human cancellous bone, and the bone tissue stimulated by metal ions can grow into the pores, and finally the prosthesis is combined with the human bone, thereby realizing the bone induction effect.

[0115] More importantly, the high-strength intervertebral fusion cage with bone induction prepared by the preparation method is prepared by mixing different types of reinforcing materials and matrix materials, such as degradable metal wire or degradable metal powder as the reinforcing material, and polyether ether ketone powder or ultra-high molecular weight polyethylene powder as the matrix material, and each reinforcing material and matrix material has its fixed preparation parameter value, such as the diameter and particle size of the reinforcing material, the particle size of the matrix material, and the pore size and porosity of the prepared multi-filled porous metal intervertebral fusion cage skeleton 6.

[0116] The selected reinforcing material and matrix material are uniformly mixed, pressure formed, sintered and prepared through the preparation process to obtain the high-strength intervertebral fusion cage with bone induction, and the above preparation process has strict and specific preparation parameters and preparation processes, such as the way of pressure forming, the sintering way, the sintering temperature and the sintering time in the sintering process, and the above preparation parameters and preparation processes are the key to prepare the high-strength intervertebral fusion cage material product with bone induction.

[0117] Secondly, the intervertebral fusion cage implant is prepared by using degradable metal materials and medical plastics, and compared with the traditional intervertebral fusion cage implant prepared by using metal materials, the overall weight is lighter, which can significantly reduce the bone loss of patients and avoid a series of chain symptoms such as osteoporosis and calcification of bone mass.

[0118] The above is only a specific embodiment of the present application, which cannot limit the scope of the application, so the replacement of equivalent components or equivalent changes and modifications made within the scope of the patent protection of the present application shall still fall within the scope of the claims of the present application.

Claims

1. An intervertebral fusion cage having osteoinductivity, characterized by: The multi-filled-pore metal intervertebral fusion cage framework is formed by interweaving wires, and filling pores are formed between the interweaved wires, and the wires are degradable metal materials; The filling pores are filled with polymer materials, and the multi-filled-pore metal intervertebral fusion cage framework is coated with a layer of polymer material on the outside; The multi-filled-pore metal intervertebral fusion cage framework includes a front end vertebral shape part and a rear end support fusion part, the front end vertebral shape part is a vertebral structure, and the rear end support fusion part is provided with a clamping groove at the rear end, and the clamping groove penetrates through the polymer material coated on the outside of the multi-filled-pore metal intervertebral fusion cage framework. The degradable metal material in the intervertebral fusion cage leaves a porous structure plastic after degradation, and the bone tissue generated by metal ion stimulation can grow into the pores of the porous structure plastic.

2. The intervertebral fusion cage having osteoinductivity of claim 1, wherein: The upper end and the lower end of the rear end support fusion part are respectively provided with outwardly protruding fixed racks, the fixed racks are arranged along the length direction of the multi-filled-pore metal intervertebral fusion cage framework, and the height of the fixed rack is 0.3mm±0.02mm.

3. The intervertebral fusion cage having osteoinductivity of claim 2, wherein: The upper end and the lower end of the rear end support fusion part are respectively provided with outwardly protruding fixed racks, the fixed racks are arranged along the length direction of the multi-filled-pore metal intervertebral fusion cage framework, and the height of the fixed rack is 0.3mm±0.02mm. The upper end and the lower end of the rear end support fusion part are respectively provided with outwardly protruding fixed racks, the fixed racks are arranged along the length direction of the multi-filled-pore metal intervertebral fusion cage framework, and the height of the fixed rack is 0.3mm±0.02mm. The upper end and the lower end of the rear end support fusion part are respectively provided with outwardly protruding fixed racks, the fixed racks are arranged along the length direction of the multi-filled-pore metal intervertebral fusion cage framework, and the height of the fixed rack is 0.3mm±0.02mm.

4. The intervertebral fusion cage having osteoinductivity of claim 3, wherein: The shape of the upper and lower penetrating bone tissue filling holes is long strip-shaped, and the shape of the left and right penetrating bone tissue filling holes is circular; The length of the long strip-shaped bone tissue filling hole is less than the length of the fixed rack, and the width of the long strip-shaped bone tissue filling hole is less than the width of the fixed rack; The diameter of the circular bone tissue filling hole is not greater than 1 / 4 of the thickness of the rear end support fusion part.

5. The intervertebral fusion cage with osteoinductivity of claim 1, wherein: The outer surface of the intervertebral fusion cage is smoothly transitioned by a round corner.

6. A method of manufacturing the intervertebral fusion cage having osteoinductivity according to any one of claims 1 to 5, characterized by: Prepare a reinforcing body material and a matrix material, the reinforcing body material is a degradable metal material, and the matrix material is a polymer material, and the preparation method comprises the following steps: Step (1): prepare a degradable metal material into a multi-filled-pore metal intervertebral fusion cage framework; Step (2): put the prepared multi-filled-pore metal intervertebral fusion cage framework and polymer material into the cavity mold respectively, uniformly fill the polymer material into the filling pores of the multi-filled-pore metal intervertebral fusion cage framework by using the oscillation method, then pressurize the uniformly mixed material through the cavity mold after pressurization, and obtain an intervertebral fusion cage semi-finished product; Step (3): put the intervertebral fusion cage forming material into a high-temperature oven for sintering, and obtain an intervertebral fusion cage with bone induction after sintering.

7. The method of claim 6, wherein the intervertebral fusion cage having osteoinductivity is prepared by the steps of: When the reinforcing body material is a degradable magnesium alloy powder and the matrix material is a polyether ether ketone powder, the preparation method comprises the following steps: Step (1): prepare a degradable magnesium alloy powder into a multi-filled-pore magnesium alloy intervertebral fusion cage framework by 3D printing method; The particle size of the degradable magnesium alloy powder is 35-85 μm, the particle size of the polyether ether ketone powder is 10-50 μm, the thickness of the multi-filled porous magnesium alloy intervertebral fusion cage framework is 8-12 mm, the pore size is 300-500 μm, and the porosity is 40-70%; Step (2): Put the prepared multi-filled porous magnesium alloy intervertebral fusion cage framework into a cavity mold, then fill the polyether ether ketone powder in the cavity mold, and adopt multiple equal filling, the filling number is three times, after each filling, uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultrasonic oscillation time is 25-40 min, and then uniformly fill the polyether ether ketone powder into the filling pores of the multi-filled porous magnesium alloy intervertebral fusion cage framework by ultrasonic oscillation, the ultr ​ 8. The method of claim 6, wherein the intervertebral fusion cage having osteoinductivity is prepared by the steps of: ​ ​ ​ ​ Step (3): the intervertebral fusion cage forming material is put into a high temperature oven for sintering, the sintering mode is hot pressing sintering, hot isostatic pressing sintering, gas pressure sintering, microwave sintering or discharge plasma sintering, the sintering temperature is 200-460℃, the sintering time is 0.8-2.3h, after sintering, the intervertebral fusion cage with bone inductivity is obtained.

9. The method of claim 7, wherein the intervertebral fusion cage having osteoinductivity is prepared by the steps of: The particle size of the degradable magnesium alloy powder in the step (1) is 50μm, the particle size of the polyether ether ketone powder is 20μm, the thickness of the magnesium alloy intervertebral fusion cage skeleton with multiple filled pores is 10mm, the pore size is 400μm, and the porosity is 60%; ​ The ultrasonic oscillation time in the step (2) is 30min, the pressure intensity is 50MPa, and the pressure holding time is 10min; The sintering mode in the step (3) is hot isostatic pressing sintering, the sintering temperature is 330℃, and the sintering time is 1h.

10. The method of claim 8, wherein the intervertebral fusion cage having osteoinductivity is prepared by the steps of: The diameter of the degradable zinc alloy wire in the step (1) is 500μm, the particle size of the ultra-high molecular weight polyethylene powder is 800μm, the thickness of the zinc alloy intervertebral fusion cage skeleton with multiple filled pores is 8mm, the pore size is 500μm, and the porosity is 80%; ​ The ultrasonic oscillation time in the step (2) is 60min, the pressure intensity is 180MPa, and the pressure holding time is 30min; The sintering mode in the step (3) is hot isostatic pressing sintering, the sintering temperature is 345℃, and the sintering time is 1.5h.

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