Method for preparing intervertebral fusion device

Abstract

The present invention relates to the technical field of intervertebral fusion devices, and in particular to a method for preparing an intervertebral fusion device. A method for preparing an intervertebral fusion device comprises: preparing a frame structure; wherein the frame structure comprises a plurality of support layers and a plurality of support columns, different support layers are parallel to each other along the thickness direction thereof and there is a gap between two adjacent support layers, the support columns are perpendicular to the support layers, each support column is fixed to the plurality of support layers, and the support layers are provided with a plurality of through holes along the thickness direction thereof; a polymer solution and mineralized collagen are mixed to obtain a mixture solution; wherein the polymer has biocompatibility; the mixture solution is poured into a mold with the frame structure placed inside to fill the through holes and the gaps with the mixed solution; the mold is freeze-dried, and an intervertebral fusion device is obtained after demolding. An embodiment of the present invention provides a method for preparing an intervertebral fusion device, which can obtain an intervertebral fusion device with excellent fusion effect and excellent mechanical strength.

Description

Technical Field

[0001] The present invention relates to the technical field of intervertebral fusion cages, and in particular to a method for preparing an intervertebral fusion cage. Background Art

[0002] With the aging of the population, spinal degenerative diseases with neck and shoulder pain and waist and leg pain as the main symptoms seriously affect people's work and life. Intervertebral fusion is currently one of the main methods for treating spinal degenerative diseases.

[0003] In the related art, the current intervertebral fusion devices are generally metal or non-metal. In order to improve the bone fusion effect, the current intervertebral fusion devices mostly have larger holes in the intervertebral fusion devices for filling with autologous bone. In order to ensure the fusion effect, the filled autologous bone needs to contact the upper and lower vertebral bone surfaces, so the holes of the intervertebral fusion devices are not closed. When implanting the intervertebral fusion device, it is necessary to knock the intervertebral fusion device to implant it into the vertebral body. However, the filled bone fragments will be shaken out of the retention hole during the knocking, so that the autologous bone in the self-retaining hole is lacking, affecting the normal recovery of the patient after surgery. At the same time, this type of intervertebral fusion device requires the filling of autologous bone, which causes secondary damage to the patient.

[0004] Therefore, in view of the above shortcomings, a method for preparing an intervertebral fusion cage is urgently needed. Summary of the invention

[0005] The embodiment of the present invention provides a method for preparing an intervertebral fusion cage, which can obtain an intervertebral fusion cage with excellent fusion effect and excellent mechanical strength.

[0006] An embodiment of the present invention provides a method for preparing an intervertebral fusion cage, comprising:

[0007] Prepare a frame structure; wherein the frame structure comprises a plurality of support layers and a plurality of support columns, different support layers are parallel to each other along the thickness direction thereof and there is a gap between two adjacent support layers, the support columns are perpendicular to the support layers, each of the support columns is fixed to the plurality of support layers, and the support layers are provided with a plurality of through holes along the thickness direction thereof;

[0008] Mixing a polymer solution and mineralized collagen to obtain a mixture solution; wherein the polymer has biocompatibility and the mineralized collagen has osteoinductive properties;

[0009] Pour the mixture solution into a mold placed inside the frame structure, so as to fill the through holes and the spaces with the mixture solution;

[0010] The mold is freeze-dried and demoulded to obtain an intervertebral fusion cage.

[0011] In one possible design, the preparation framework structure includes:

[0012] The frame structure is prepared by using 3D printing technology.

[0013] In a possible design, after the mixed solution fills the through-holes and the intervals and before the mold is freeze-dried, the process further includes:

[0014] The mold is subjected to an oscillation treatment and an ultrasonic treatment in sequence.

[0015] In a possible design, the concentration of the mixture solution is 0.05-0.2 g / ml, the solute of the polymer solution includes at least one of polycaprolactone, polylactic acid and polylactic acid-glycolic acid copolymer, and the solvent of the polymer includes at least one of 1,4-dioxane, chloroform, acetone and dimethyl sulfoxide;

[0016] The mass ratio of the mineralized collagen to the solute is (2-4):1.

[0017] In one possible design, the freeze-drying process includes pre-freezing, sublimation and vacuum drying;

[0018] The pre-freezing is performed at normal pressure and -40 to -20°C for 4 to 6 hours;

[0019] The sublimation is carried out in vacuum at -10 to 0°C for 24 to 32 hours;

[0020] The vacuum drying is performed at 0-50°C for 10-20h.

[0021] In a possible design, the support layer includes a plurality of plates, the thickness direction of the plates and the thickness direction of the support layer are perpendicular to each other, and the plates are staggered to form the through holes.

[0022] In a possible design, the projection of the support layer along the thickness direction thereof is mutually interlaced line segments, the line segments are interlaced to form an intersection, and the projection of the support column along the thickness direction of the support layer falls into the intersection.

[0023] In a possible design, the diameter of the support column is the same as the thickness of the plate body.

[0024] In a possible design, the cross section of the through hole is square.

[0025] In a possible design, the ratio of the width to the thickness of the plate is (3-4):1, the ratio of the width of the plate to the side length of the square is (2-3):1, and the ratio of the interval to the width of the plate is (0.8-1.2):1.

[0026] In a possible design, an anti-slip cone is provided on the outer side of the frame structure.

[0027] Compared with the prior art, the present invention has at least the following beneficial effects:

[0028] In this embodiment, a frame structure is prepared; wherein the frame structure includes a plurality of support layers and a plurality of support columns, different support layers are parallel to each other along the thickness direction thereof and there is a gap between two adjacent support layers, the support columns are perpendicular to the support layers, each support column is fixed to the plurality of support layers, and the support layers are provided with a plurality of through holes along the thickness direction thereof; in this way, the support layers are connected to each other through the support columns to form a frame structure including through holes and interlayer gaps, and the frame structure itself has excellent mechanical strength, and in addition, the support layers are layered, and in this way, after the intervertebral fusion device is implanted into the vertebral body, it can be ensured that it will not be significantly deviated in the horizontal direction when subjected to pressure; the support layer utilizes the support The support column is connected and fixed, which can not only provide mechanical strength in the vertical direction, but also connect and fix the support layer while maintaining the interval, and can also produce a certain degree of bending when subjected to force to meet the use requirements of spine curvature. It should be noted that the above-mentioned bending occurs when there is basically no offset in the horizontal direction of the entire intervertebral fusion device. The force offset in the vertical direction can cause the support column to bend to different degrees. Specifically, one end of the intervertebral fusion device is slightly compressed, and the support column at this point is more bent. The other end of the intervertebral fusion device is basically not compressed, and the support column has no bending or a small bending degree. In addition, the above-mentioned bending is elastic deformation. When the pressure is reduced, the support column returns to the vertical direction.

[0029] The polymer solution and mineralized collagen are mixed to obtain a mixture solution; wherein the polymer has biocompatibility; the mixed solution prepared by the biocompatible polymer and mineralized collagen can replace autologous bone and fuse with the vertebral body, wherein the polymer has excellent flexibility and biocompatibility, can provide excellent mechanical strength, and the performance of mineralized collagen is similar to that of natural bone in both microstructure and composition, and has good biocompatibility and bone induction repair ability. Mineralized collagen is degradable, and osteoblasts and nutrients can enter the through hole as the mineralized collagen degrades, promoting the effect of intervertebral fusion.

[0030] The mixed solution is poured into a mold with a frame structure placed inside, so as to fill the through holes and the gaps with the mixed solution; in this way, the mixed solution with fluidity can be fully filled in the through holes and the gaps.

[0031] The mold is freeze-dried, and the intervertebral fusion device is obtained after demolding; in this way, the mixed solution that fully fills the through holes and gaps forms a solid after freeze-drying, and the freeze-drying process allows the obtained solid to be tightly bonded and fixed to the frame structure. In addition, the freeze-drying process also forms a microporous structure inside the formed solid, and the microporous structure is conducive to the growth and migration of new bone tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0033] Figure 1 is a flow chart of a method for preparing an intervertebral fusion cage provided by an embodiment of the present invention;

[0034] Figure 2 is a flow chart of another method for preparing an intervertebral fusion cage provided by an embodiment of the present invention;

[0035] Figure 3 is a schematic structural diagram of an intervertebral fusion device provided by an embodiment of the present invention;

[0036] Figure 4 It is a structural schematic diagram of a framework structure provided by an embodiment of the present invention;

[0037] Figure 5 is a structural schematic diagram of another frame structure provided by an embodiment of the present invention;

[0038] Figure 6 It is a structural schematic diagram of a support layer provided by an embodiment of the present invention.

[0039] In the figure:

[0040] 1-Frame structure;

[0041] 11- supporting layer;

[0042] 111-Plate body;

[0043] 112-through hole;

[0044] 12- support column;

[0045] 13- Anti-slip cone;

[0046] 2- solid;

[0047] H1-thickness of the support layer;

[0048] H2-the thickness of the board. DETAILED DESCRIPTION

[0049] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0050] In the description of the embodiments of the present invention, unless otherwise clearly specified and limited, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance; unless otherwise specified or explained, the term "multiple" refers to two or more; the terms "connected" and "fixed" should be understood in a broad sense, for example, "connected" can be a fixed connection, a detachable connection, an integral connection, or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0051] In the description of this specification, it should be understood that the directional words such as "upper" and "lower" described in the embodiments of the present invention are described at the angles shown in the drawings and should not be understood as limiting the embodiments of the present invention. In addition, in the context, it should also be understood that when it is mentioned that an element is connected to another element "upper" or "lower", it can not only be directly connected to another element "upper" or "lower", but also indirectly connected to another element "upper" or "lower" through an intermediate element.

[0052] like Figure 1 As shown, an embodiment of the present invention provides a method for preparing an intervertebral fusion cage, comprising:

[0053] Step 100: Prepare a framework structure 1; wherein: Figure 5 As shown, the frame structure 1 includes a plurality of support layers 11 and a plurality of support columns 12, different support layers 11 are parallel to each other along the thickness direction thereof and there is a gap between two adjacent support layers 11, the support columns 12 are perpendicular to the support layers 11, each support column 12 is fixed to the plurality of support layers 11, and the support layer 11 is provided with a plurality of through holes 112 along the thickness direction thereof;

[0054] Step 102, mixing the polymer solution and the mineralized collagen to obtain a mixture solution; wherein the polymer has biocompatibility and the mineralized collagen has osteoinductive properties;

[0055] Step 104, pouring the mixed solution into the mold placed inside the frame structure 1, so as to fill the through holes 112 and the gaps with the mixed solution;

[0056] Step 106: freeze-dry the mold, and after demoulding, obtain Figure 3 Interbody fusion cage shown.

[0057] In this embodiment, a frame structure 1 is prepared; wherein the frame structure 1 includes a plurality of support layers 11 and a plurality of support columns 12, wherein different support layers 11 are parallel to each other along their thickness direction and there is a gap between two adjacent support layers 11, the support columns 12 are perpendicular to the support layers 11, and each support column 12 is fixed to the plurality of support layers 11, and the support layer 11 is provided with a plurality of through holes 112 along its thickness direction; in this way, the support layers 11 are connected to each other through the support columns 12 to form a frame structure 1 including through holes 112 and interlayer gaps, and the frame structure 1 itself has excellent mechanical strength. In addition, the support layer 11 is layered, and in this way, after the intervertebral fusion device is implanted into the vertebral body, it can be ensured that when it is subjected to pressure, no obvious horizontal deformation will occur. The support layer 11 is connected and fixed by the support column 12, which can not only provide mechanical strength in the vertical direction, but also connect and fix the support layer 11 under the condition of maintaining the interval, and can also produce a certain degree of bending when subjected to force to meet the use requirements of the spine curvature. It should be noted that the above-mentioned bending occurs when there is basically no offset in the horizontal direction of the entire intervertebral fusion device, and the force offset in the vertical direction will cause the support column 12 to bend to different degrees. Specifically, one end of the intervertebral fusion device is slightly compressed, and the support column 12 at this point is more bent. The other end of the intervertebral fusion device is basically not compressed, and the support column 12 has no bending or a small bending degree. Moreover, the above-mentioned bending is elastic deformation. When the pressure is reduced, the support column 12 returns to the vertical direction.

[0058] The polymer solution and the mineralized collagen are mixed to obtain a mixture solution; wherein the polymer has biocompatibility; the mixed solution prepared by the biocompatible polymer and the mineralized collagen can replace the autologous bone and fuse with the vertebral body, wherein the polymer has excellent flexibility and biocompatibility and can provide excellent mechanical strength, and the performance of the mineralized collagen is similar to that of natural bone in terms of microstructure and composition, and has good biocompatibility and bone induction repair ability. The mineralized collagen is degradable, and osteoblasts and nutrients can enter the through hole 112 as the mineralized collagen degrades, thereby promoting the effect of intervertebral fusion.

[0059] The mixed solution is poured into a mold placed inside the frame structure 1 to fill the through holes 112 and the gaps with the mixed solution. With this arrangement, the mixed solution with fluidity can be fully filled in the through holes 112 and the gaps.

[0060] The mold is freeze-dried and demolded to obtain an intervertebral fusion device; in this way, the mixed solution that fully fills the through hole 112 and the gap forms a solid 2 after freeze-drying. The freeze-drying process allows the obtained solid 2 to be tightly bonded and fixed to the frame structure 1. In addition, the freeze-drying process also forms a microporous structure inside the formed solid 2, which is beneficial to the growth and migration of new bone tissue.

[0061] It is understood that the solid 2 is integrally formed, and the frame structure 1 and the integrally formed solid 2 are combined to form a structure similar to reinforced concrete, which has excellent mechanical strength. In addition, the structure of the support layer 11 and the support column 12 can have a stronger bonding strength with the filled solid 2, and will not cause the solid 2 to fall off during use.

[0062] In some embodiments of the present invention, preparing the framework structure 1 comprises:

[0063] The frame structure 1 is prepared by using 3D printing technology.

[0064] In this embodiment, the specific method of preparing the frame structure 1 using 3D printing technology is as follows: according to personalized needs, a model of the frame structure 1 is established using digital modeling software (such as AUTO CAD, ProE or UG), and the obtained model is saved in STL format and imported into Med CAD software, and a series of slices with a thickness of 0.1 mm are cut out; the slice data obtained for each slice is imported into a 3D printing automatic molding machine; the implant-grade polyetheretherketone material is ball-milled and sieved to obtain polyetheretherketone material particles with a particle size of less than 0.2 mm; the polyetheretherketone material particles are imported into the material barrel of the 3D printing automatic molding machine, the nozzle heating block temperature is 350-395°C, the nozzle size is 0.3-0.4mm, the printing thickness is 0.1-0.3mm, the pressure is 0.5-5MPa, and the manufactured structure is printed layer by layer.

[0065] In some embodiments of the present invention, after the mixed solution fills the through hole 112 and the space and before the mold is freeze-dried, the method further includes:

[0066] The mold is subjected to vibration treatment and ultrasonic treatment in sequence.

[0067] In this embodiment, the shaking treatment and ultrasonic treatment can make the mixture solution fully dispersed in the through holes 112 and gaps of the frame structure 1 .

[0068] In some embodiments of the present invention, the concentration of the mixture solution is 0.05 to 0.2 g / ml, the solute of the polymer solution includes at least one of polycaprolactone, polylactic acid and polylactic acid-co-glycolic acid, and the solvent of the polymer includes at least one of 1,4-dioxane, chloroform, acetone and dimethyl sulfoxide;

[0069] The mass ratio of mineralized collagen and solute is (2-4):1.

[0070] In this embodiment, if the concentration of the mixture solution is less than 0.05g / ml, the solid 2 obtained by freeze-drying has poor mechanical strength. If the concentration of the mixture solution is greater than 0.2g / ml, the mixed solution has poor fluidity and cannot fully fill the through holes 112 and gaps of the framework structure 1. In addition, the porosity of the microporous structure of the obtained solid 2 is too low, which affects the growth of new bone tissue. Polycaprolactone, polylactic acid and polylactic acid-glycolic acid copolymers have strong flexibility, and 1,4-dioxane, chloroform, acetone and dimethyl sulfoxide can fully dissolve the above polymers. The mass ratio of mineralized collagen and solute is (2-4):1. If the ratio of the two is higher than the above range, the mechanical strength of the obtained solid 2 is poor. If the ratio of the two is lower than the above range, the fusion effect of the obtained solid 2 is poor.

[0071] In this embodiment, the preparation method of mineralized collagen is as follows:

[0072] S1. Dissolving type I collagen in any one of hydrochloric acid, nitric acid or acetic acid to prepare an acid solution of collagen, wherein the concentration of collagen is 0.01 to 0.5 g / mL;

[0073] S2, continuously stirring the solution obtained in step S1, slowly adding a solution containing calcium ions, wherein the amount of calcium ions added is 0.1 to 2 mol per gram of collagen;

[0074] S3, continuously stirring the solution obtained in step S2, slowly adding a solution containing phosphate ions, wherein the molar ratio of the amount of phosphate ions added to the amount of calcium ions added in step S2 is Ca / P=1 / 1 to 2 / 1;

[0075] S4, continuously stirring the solution obtained in step S3, and slowly adding NaOH solution until the pH of the mixed system is 6-8;

[0076] S5. The mixed system obtained in step S4 is allowed to stand for 4 to 12 hours, and the precipitate is centrifuged at a speed of 3000 to 6000 r / min and then dried by forced air at 50 to 70° C. for 24 to 72 hours, and then crushed and sieved to obtain mineralized collagen particles with a particle size of 50 to 100 nm.

[0077] In some embodiments of the present invention, the freeze-drying process includes pre-freezing, sublimation and vacuum drying;

[0078] Prefreeze at normal pressure, -40~-20℃ for 4-6h;

[0079] Sublimation is to sublime in vacuum at -10 to 0°C for 24 to 32 hours;

[0080] Vacuum drying is performed at 0-50°C for 10-20 hours.

[0081] In this embodiment, the solvent in the mixture can be removed quickly and efficiently through pre-freezing, sublimation and vacuum drying, and the obtained solid 2 and the framework structure 1 can be tightly and firmly combined.

[0082] Please refer to Figure 6 In some embodiments of the present invention, the support layer 11 includes a plurality of plates 111 , the thickness direction ( H2 ) of the plates 111 and the thickness direction ( H1 ) of the support layer 11 are perpendicular to each other, and the plates 111 are staggered to form through holes 112 .

[0083] In this embodiment, the support layer 11 includes multiple plates 111, and the thickness (H2) direction of the plate bodies 111 and the thickness (H1) direction of the support layer 11 are perpendicular to each other. The plates 111 are staggered to form through holes 112. In this way, the support layer 11 composed of the plate bodies 111 can save space to obtain more through holes 112, and increase its contact area with the filling solid 2 to increase the bonding strength between the frame structure 1 and the filling solid 2, thereby improving the overall mechanical strength of the intervertebral fusion device.

[0084] It is understandable that multiple groups of plates 111 can be interlaced to obtain through holes 112 of different shapes. The cross-section of the through hole 112 can be triangular, quadrilateral, or pentagonal; the shape of each through hole 112 can be the same or different.

[0085] Please refer to Figure 5 In some embodiments of the present invention, the projection of the support layer 11 along the thickness (H1) direction thereof is mutually interlaced line segments, which form an intersection after interlacing, and the projection of the support column 12 along the thickness (H1) direction of the support layer 11 falls into the intersection.

[0086] In this embodiment, both ends of the support column 12 are connected to the intersection of the plate body 111 respectively, and the connection point is the intersection of the two plate bodies 111. With this arrangement, the bonding strength between the support column 12 and the support layer 11 is higher.

[0087] In some embodiments of the present invention, the diameter of the support column 12 is the same as the thickness ( H2 ) of the plate body 111 .

[0088] In this embodiment, the diameter of the support column 12 is the same as the thickness of the plate body 111. If the diameter of the support column 12 is larger than the thickness of the plate body 111, it will occupy more space and compress the space of the filling solid 2. If the diameter of the support column 12 is smaller than the thickness of the plate body 111, the support column 12 will be fragile and easy to break.

[0089] Please refer to Figure 6In some embodiments of the present invention, the cross-section of the through hole 112 is square.

[0090] In this embodiment, the cross-section of the through hole 112 is square, that is, the through hole 112 has a square columnar space. This arrangement can save materials and have excellent mechanical strength at the same size. In addition, under the condition of the same size, the number of through holes 112 formed is the largest and the porosity is the largest.

[0091] In some embodiments of the present invention, the ratio of the width to thickness of the plate 111 is (3-4):1, the ratio of the width of the plate 111 to the side length of the square is (2-3):1, and the ratio of the interval to the width of the plate 111 is (0.8-1.2):1.

[0092] In this embodiment, the ratio of the width to the thickness of the plate 111 is (3-4):1. If the ratio is higher than the above range, the plate 111 is too thin and has poor support. If the ratio is lower than the above range, the plate 111 is too thick and occupies a large space. The ratio of the width of the plate 111 to the side length of the square is (2-3):1, and the ratio of the height to the bottom side length of the square through hole 112 is (2-3):1. With this arrangement, the intervertebral fusion device is not prone to horizontal displacement when subjected to pressure. The ratio of the spacing to the width of the plate 111 is (0.8-1.2):1. With this arrangement, the spacing distance between the support layers 11 is close to the thickness of the support layer 11, and the frame structure 1 and the intervertebral fusion device have higher symmetry and higher mechanical strength.

[0093] In this embodiment, the intervertebral fusion cage may be a trapezoid with gradually increasing horizontal dimensions, and the overall dimensions of the intervertebral fusion cage may be 10 to 20 mm in width, 10 to 20 mm in depth, and 5 to 15 mm in height. The diameter of the support column 12 is 0.5 to 1 mm, the distance between the centers of the support columns 12 is 1 to 1.5 mm, and the support layer 11 is provided at intervals of 1.2 to 4.8 mm.

[0094] Please refer to Figure 4 In some embodiments of the present invention, an anti-slip cone 13 is provided on the outer side of the frame structure 1.

[0095] In this embodiment, the anti-slip cone 13 is used to make the connection between the intervertebral fusion cage and the vertebral body more tightly. The anti-slip cone 13 is 0.5-1.5 mm wide, 0.5-2 mm deep, and 0.5-1.5 mm high.

[0096] It should be noted that the anti-slip cone 13 can be disposed on the frame structure 1 via a contact layer provided with a through hole 112 .

[0097] like Figure 2 As shown, the embodiment of the present invention also provides another method for preparing an intervertebral fusion cage, comprising:

[0098] Step 200, preparing the frame structure 1 by using 3D printing technology; wherein the frame structure 1 includes a plurality of support layers 11 and a plurality of support columns 12, different support layers 11 are parallel to each other along the thickness direction thereof and there is a gap between two adjacent support layers 11, the support columns 12 are perpendicular to the support layers 11, each support column 12 is fixed to the plurality of support layers 11, and the support layer 11 is provided with a plurality of through holes 112 along the thickness direction thereof;

[0099] Step 202, mixing a polymer solution and mineralized collagen to obtain a mixture solution; wherein the polymer has biocompatibility, and the mineralized collagen has osteoinductive properties;

[0100] Step 204, pouring the mixed solution into the mold placed inside the frame structure 1, so as to fill the through holes 112 and the gaps with the mixed solution;

[0101] Step 206, sequentially performing vibration treatment and ultrasonic treatment on the mold;

[0102] Step 208: freeze-dry the mold and demould to obtain the intervertebral fusion cage.

[0103] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for preparing an intervertebral fusion cage, characterized in that: include: Prepare a frame structure; wherein the frame structure is made of polyetheretherketone, the frame structure comprises a plurality of support layers and a plurality of support columns, different support layers are parallel to each other along the thickness direction thereof and there is a gap between two adjacent support layers, the support columns are perpendicular to the support layers, each support column is fixed to a plurality of support layers, and the support layers are provided with a plurality of through holes along the thickness direction thereof; Mixing a polymer solution and mineralized collagen to obtain a mixture solution; wherein the polymer has biocompatibility and the mineralized collagen has osteoinductive properties; Pouring the mixture solution into a mold placed inside the frame structure to fill the through holes and the spaces with the mixture solution; The mold is freeze-dried, and an intervertebral fusion cage is obtained after demoulding; The support layer comprises a plurality of plates, the thickness direction of the plates and the thickness direction of the support layer are perpendicular to each other, and the plates are staggered to form the through holes; The projection of the support layer along the thickness direction thereof is mutually interlaced line segments, the line segments are interlaced to form an intersection, and the projection of the support column along the thickness direction of the support layer falls into the intersection; The diameter of the support column is the same as the thickness of the plate body; The cross section of the through hole is a square; The ratio of the width to the thickness of the plate is (3-4):1, the ratio of the width of the plate to the side length of the square is (2-3):1, and the ratio of the interval to the width of the plate is (0.8-1.2):1; The intervertebral fusion cage is a trapezoid with gradually increasing horizontal dimensions, with a width of 10-20 mm, a depth of 10-20 mm, a height of 5-15 mm, a support column diameter of 0.5-1 mm, a distance between the centers of the support columns of 1-1.5 mm, and a support layer with an interval of 1.2-4.8 mm. An anti-slip cone is arranged on the outer side of the frame structure.

2. The preparation method according to claim 1, characterized in that: The preparation framework structure comprises: The frame structure is prepared by using 3D printing technology.

3. The preparation method according to claim 1, characterized in that: After the mixture solution fills the through holes and the spaces and before the mold is freeze-dried, the method further comprises: The mold is subjected to an oscillation treatment and an ultrasonic treatment in sequence.

4. The preparation method according to claim 1, characterized in that: The concentration of the mixture solution is 0.05-0.2 g / ml, the solute of the polymer solution includes at least one of polycaprolactone, polylactic acid and polylactic acid-co-glycolic acid, and the solvent of the polymer includes at least one of 1,4-dioxane, chloroform, acetone and dimethyl sulfoxide; The mass ratio of the mineralized collagen to the solute is (2~4):

1.

5. The preparation method according to claim 1, characterized in that: The freeze-drying process includes pre-freezing, sublimation and vacuum drying; The pre-freezing is performed at normal pressure and -40 to -20°C for 4 to 6 hours; The sublimation is performed in vacuum at -10 to 0°C for 24 to 32 hours; The vacuum drying is performed at 0-50° C. for 10-20 hours.

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