Spinal fusion cage and preparation method thereof

Abstract

The invention relates to a preparation method of a spinal fusion cage and the spinal fusion cage, and the method comprises the following steps: providing a silk fibroin hexafluoroisopropanol solution, uniformly mixing silk fibroin powder and hexafluoroisopropanol in the silk fibroin hexafluoroisopropanol solution according to a ratio of 1g: (1-10) mL, adding a photoinitiator aqueous solution, and uniformly stirring to obtain the silk fibroin hexafluoroisopropanol solution. The preparation method comprises the following steps: preparing a hydrogel, injecting the hydrogel into a mold, standing and solidifying to obtain an initial hydrogel, putting the initial hydrogel under ultraviolet irradiation to carry out photo-crosslinking treatment to obtain a photo-crosslinking hydrogel, and then sequentially carrying out soaking washing and drying treatment on the photo-crosslinking hydrogel to obtain the photo-crosslinking hydrogel plate, the spine fusion cage is obtained by machining based on the photo-crosslinking hydrogel plate, so that the prepared spine fusion cage has good biocompatibility, the mechanical property is closer to that of a spine, the biodegradation rate is proper, and the preparation process can be suitable for large-scale production.

Description

Technical Field

[0001] This application relates to the field of biomedical device technology, and in particular to a method for preparing a spinal fusion device and the spinal fusion device itself. Background Technology

[0002] A spinal fusion cage is an instrument used in conjunction with spinal fusion surgery. Its main function is to open the intervertebral space and maintain its height, restore the physiological curvature of the spine, reconstruct and maintain spinal stability, and ultimately achieve local bony fusion. Currently, spinal fusion cages are classified into two categories based on materials: metallic spinal fusion cages and non-metallic spinal fusion cages. Metallic spinal fusion cages are represented by titanium alloys, while non-metallic spinal fusion cages are further divided into biodegradable and non-biodegradable materials. In practical applications of spinal fusion cages, it has been found that metallic spinal fusion cages, due to the excessively high elastic modulus of the metal material (such as titanium alloy, which has an elastic modulus as high as 110 GPa), far exceed the elastic modulus of the human vertebral body (3.8~11 GPa). This can cause a stress shielding effect, resulting in a lack of corresponding stress stimulation for new bone formation, leading to slow bone formation. At the same time, the excessively high elastic modulus can also lead to osteoporosis of adjacent vertebral bodies, making the fusion cage prone to sinking and ultimately resulting in loss of intervertebral space height.

[0003] Compared to metallic spinal fusion braces, non-metallic spinal fusion braces have an elastic modulus closer to that of the human vertebral body. These mainly include carbon fiber spinal fusion braces, polyetheretherketone (PEEK) spinal fusion braces, and biodegradable polylactic acid (PLA) spinal fusion braces. Among these, carbon fiber tends to produce debris in the body, potentially causing inflammatory reactions; while PEEK spinal fusion braces, although having an elastic modulus close to cortical bone, are non-bioactive and non-degradable, making it difficult to form a tight bond with bone; and although PLA spinal fusion braces are bioabsorbable, their degradation rate is too rapid, and local lactic acid accumulation during degradation can lead to high concentrations of lactic acid that can cause inflammatory reactions.

[0004] Therefore, there is an urgent need for a spinal fusion device that is biocompatible, has mechanical properties close to those of the spine, is naturally biodegradable, and has a suitable degradation rate. Summary of the Invention

[0005] In view of the above-mentioned problems in the prior art, the purpose of this application is to provide a method for preparing a spinal fusion device and a spinal fusion device. The main materials of the prepared spinal fusion device are derived from natural sources, the mechanical properties are closer to those of the spine, the biocompatibility is good, and the biodegradation rate is appropriate.

[0006] On one hand, this application provides a method for preparing a spinal fusion device, the method comprising: A silk fibroin hexafluoroisopropanol solution is provided; the ratio of silk fibroin powder to hexafluoroisopropanol in the silk fibroin hexafluoroisopropanol solution is 1g:(1~10)mL; After the silk fibroin hexafluoroisopropanol solution was mixed evenly with the photoinitiator aqueous solution, it was injected into a mold and allowed to stand and solidify to obtain the initial hydrogel. The initial hydrogel was subjected to photocrosslinking treatment under ultraviolet light to obtain a photocrosslinked hydrogel. The photocrosslinked hydrogel was sequentially soaked and dried to obtain a photocrosslinked hydrogel board. A spinal fusion device is obtained by mechanical processing based on the photocrosslinked hydrogel sheet.

[0007] In one exemplary embodiment, the step of sequentially soaking and drying the photocrosslinked hydrogel to obtain a photocrosslinked hydrogel board includes: The photocrosslinked hydrogel was soaked in ultrapure water for 5-10 days to obtain the soaked photocrosslinked hydrogel. The photocrosslinked hydrogel that has been soaked and washed is dried by air drying at room temperature to obtain the photocrosslinked hydrogel board.

[0008] In one exemplary embodiment, during the soaking process, freshly prepared ultrapure water is used daily; the time for natural air drying at room temperature is 1 to 30 days. In one exemplary embodiment, the mechanical processing based on the photocrosslinked hydrogel sheet to obtain the spinal fusion device includes: The photocrosslinked hydrogel sheet is integrally molded into a spinal fusion device; wherein the spinal fusion device includes a first fusion surface and a second fusion surface opposite to each other, and a bone graft window is formed in the spinal fusion device at a position away from the edge, penetrating the first fusion surface and the second fusion surface, and a plurality of fixation points for cooperating with tantalum metal rods are distributed around the periphery of the bone graft window.

[0009] In one exemplary embodiment, the first fusion surface and / or the second fusion surface are rough tooth surfaces.

[0010] In one exemplary embodiment, the step of uniformly mixing the silk fibroin hexafluoroisopropanol solution with the photoinitiator aqueous solution, injecting it into a mold, and allowing it to solidify to obtain the initial hydrogel includes: The photoinitiator aqueous solution is added to the silk fibroin hexafluoroisopropanol solution, mixed evenly, and then injected into a mold. The mixture is allowed to stand and solidify at a temperature of 5-40°C for 1-5 days to obtain the initial hydrogel.

[0011] In one exemplary embodiment, the concentration of the photoinitiator in the photoinitiator aqueous solution is 0.1~0.5%; the volume ratio of the silk fibroin hexafluoroisopropanol solution to the photoinitiator aqueous solution is 5:4~5:1.

[0012] In one exemplary embodiment, the wavelength of the ultraviolet light is 254~365nm, and the irradiation duration is 10~60min.

[0013] On the other hand, this application provides a spinal fusion device, which is prepared by any of the spinal fusion device adhesive preparation methods described above.

[0014] In one exemplary embodiment, the spinal fusion device includes opposing first and second fusion surfaces, and the spinal fusion device has a bone graft window extending through the first and second fusion surfaces at a location away from the edge. A plurality of fixation points for engaging with tantalum metal rods are distributed around the periphery of the bone graft window; the first and / or second fusion surfaces are rough toothed surfaces.

[0015] This application provides a silk fibroin hexafluoroisopropanol solution, wherein the ratio of silk fibroin powder to hexafluoroisopropanol in the silk fibroin hexafluoroisopropanol solution is 1g:(1~10)mL. Then, the silk fibroin hexafluoroisopropanol solution is mixed evenly with a photoinitiator aqueous solution and injected into a mold. After static solidification, an initial hydrogel is obtained. The initial hydrogel is then subjected to photocrosslinking treatment under ultraviolet light to obtain a photocrosslinked hydrogel. The photocrosslinked hydrogel is then subjected to soaking and drying treatments to obtain a photocrosslinked hydrogel board. Based on the photocrosslinked hydrogel board, a spinal fusion device is obtained through mechanical processing. Since silk fibroin is a natural high molecular weight protein, it has good biocompatibility with the photoinitiator and can improve the brittleness of silk fibroin itself. This results in a spinal fusion device with good biocompatibility and mechanical properties that are closer to those of the spine. Moreover, the preparation process is suitable for large-scale production. Attached Figure Description

[0016] To more clearly illustrate the technical solutions of the present invention, the accompanying drawings used in the description of the embodiments or prior art will be briefly introduced below. Obviously, the drawings described below are merely some embodiments of the present invention, and those skilled in the art can obtain other drawings based on these drawings without any creative effort.

[0017] Figure 1 This is a schematic flowchart of a method for preparing a spinal fusion device provided in an embodiment of this application; Figure 2 This is a schematic diagram of a spinal fusion device prepared based on the preparation method of the embodiments of this application. Detailed Implementation

[0018] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0019] This application provides a method for preparing a spinal fusion device, such as... Figure 1 As shown, the method includes the following steps: First, perform step S1: provide a silk fibroin hexafluoroisopropanol solution, wherein the ratio of silk fibroin powder to hexafluoroisopropanol in the silk fibroin hexafluoroisopropanol solution is 1g:(1~10)mL.

[0020] Specifically, providing a silk fibroin hexafluoroisopropanol solution may include: providing silk fibroin powder, dissolving the silk fibroin powder in hexafluoroisopropanol to obtain the silk fibroin hexafluoroisopropanol solution, wherein the dissolution time can be 1~100h, and the dissolution temperature can be 5~80℃, to ensure that the natural silk fibroin freeze-dried powder is fully dissolved by hexafluoroisopropanol. In practical applications, to prevent the volatilization of hexafluoroisopropanol, the above dissolution process must be carried out in a sealed container.

[0021] For example, silk fibroin powder is prepared by sequentially degumming, rinsing, drying, dissolving, dialysis, centrifuging, and freeze-drying natural silkworm cocoons.

[0022] Next, proceed to step S2: After uniformly mixing the silk fibroin hexafluoroisopropanol solution with the photoinitiator aqueous solution, inject the mixture into a mold and allow it to stand and solidify to obtain the initial hydrogel.

[0023] Specifically, an aqueous solution of photoinitiator can be prepared first. The concentration of photoinitiator in the aqueous solution is 0.1-0.5%, the dissolution time is 0.1-48 hours, and the dissolution temperature is 5-80℃. The mixing method can be mechanical mixing or oscillating and turning mixing to make the mixing more uniform and improve the effect of subsequent photocrosslinking.

[0024] When injecting into the mold, the well-mixed solution can be poured into a syringe first, and then injected into the mold using the syringe to improve the uniformity of the resulting initial hydrogel.

[0025] For example, in step S2 above, the photoinitiator aqueous solution is added to the silk fibroin hexafluoroisopropanol solution, mixed evenly, and then injected into a mold. The mixture is then allowed to stand and solidify at 5-40°C for 1-5 days to obtain the initial hydrogel. Considering that adding the silk fibroin hexafluoroisopropanol solution to the photoinitiator aqueous solution will cause rapid gel aging and the formation of flocculent material, resulting in material inhomogeneity in the final spinal fusion device, this embodiment of the application adds the photoinitiator aqueous solution to the silk fibroin hexafluoroisopropanol solution to improve the material homogeneity of the final spinal fusion device.

[0026] For example, the volume ratio of the silk fibroin hexafluoroisopropanol solution to the photoinitiator aqueous solution is 5:4 to 5:1.

[0027] Next, step S3 is performed: the initial hydrogel is placed under ultraviolet light for photocrosslinking treatment to obtain a photocrosslinked hydrogel.

[0028] Specifically, after demolding the solidified initial hydrogel, it is placed under ultraviolet light for photocrosslinking treatment to obtain a photocrosslinked hydrogel. The wavelength of the ultraviolet light can be 254~365nm, and the irradiation time can be 10~60min.

[0029] Next, step S4 is performed: the photocrosslinked hydrogel is soaked and dried sequentially to obtain a photocrosslinked hydrogel board.

[0030] For example, the photocrosslinked hydrogel is soaked in ultrapure water for 5-10 days to obtain a soaked photocrosslinked hydrogel; then, the soaked photocrosslinked hydrogel is dried naturally at room temperature to obtain the photocrosslinked hydrogel board. Since the deformation caused by natural drying at room temperature is small, it has little impact on product performance and is beneficial to improving the mechanical properties of the prepared spinal fusion device.

[0031] For example, during the soaking process, freshly prepared ultrapure water is used daily to ensure thorough soaking. The natural air-drying time at room temperature can be 1 to 30 days.

[0032] Next, step S5 is performed: mechanical processing is carried out based on the photocrosslinked hydrogel sheet to obtain the spinal fusion device.

[0033] For example, the photocrosslinked hydrogel sheet is integrally molded into a spinal fusion device; wherein, the spinal fusion device includes a first fusion surface and a second fusion surface opposite to each other, and the spinal fusion device has a bone graft window that penetrates the first fusion surface and the second fusion surface at a position away from the edge, and a plurality of fixation points for cooperating with tantalum metal rods are distributed around the periphery of the bone graft window.

[0034] Specifically, a bone graft window can penetrate the first and second fusion surfaces at the center of the spinal fusion cage, and the size of the opening of the bone graft window can be set according to actual needs. Fixation points for cooperating with tantalum metal rods can be evenly distributed around the periphery of the bone graft window. For example, the number of fixation points can be three. The tantalum metal rods can fix the spinal fusion cage between the vertebrae through the fixation points.

[0035] For example, the first fusion surface and / or the second fusion surface are toothed surfaces, that is, the first fusion surface and / or the second fusion surface can be formed with protruding teeth to increase friction, prevent displacement or rotation, and improve the stability and fusion success rate of the spinal fusion device.

[0036] Since silk fibroin is a natural high-molecular-weight protein, it can be photocrosslinked with photoinitiators, resulting in good biocompatibility. This can improve the brittleness of silk fibroin itself, making the prepared spinal fusion device have good biocompatibility, mechanical properties that are closer to those of the spine, adjustable biodegradation rate, and the preparation process suitable for large-scale production.

[0037] This application also provides a spinal fusion device prepared by the above preparation method. The main material of the spinal fusion device is natural, its mechanical properties are closer to those of the spine, it has good biocompatibility, and its biodegradation rate is suitable.

[0038] For example, such as Figure 2 The diagram shown is a schematic of a spinal fusion device prepared according to the preparation method of the spinal fusion device in the embodiment of this application. Figure 2 As shown, the spinal fusion device 200 includes a first fusion surface 201 and a second fusion surface 202 opposite to each other. The first fusion surface 201 and the second fusion surface 202 are used to contact the vertebral plate of the spine, and the first fusion surface 201 and / or the second fusion surface 202 can be toothed to increase friction, prevent displacement or rotation, and improve the stability and fusion success rate of the spinal fusion device.

[0039] The spinal fusion device 200 has a bone graft window 203 formed at a position away from the edge, penetrating the first fusion surface 201 and the second fusion surface 202. A plurality of fixation points 204 for cooperating with tantalum metal rods are distributed around the periphery of the bone graft window 203. For example, there are 3 fixation points 204. The tantalum metal rods fix the spinal fusion device 200 between the vertebrae through each fixation point 204, thereby guiding the spinal recovery and providing a force-bearing structure.

[0040] To further illustrate the embodiments of this application, the preparation method of the spinal fusion device provided in this application will be described in detail below with reference to specific embodiments.

[0041] Preparation of silk fibroin powder: (1) Degumming: Remove impurities from natural silkworm cocoons, cut them into pieces, and weigh 10g. Take 4L of purified water, add 8.48g of sodium carbonate to dissolve, and obtain a sodium carbonate solution of 2.12g / L. Place the solution in an electric furnace or steam boiler and heat it to 50~121℃. Add the weighed silkworm cocoons to the heated sodium carbonate solution and continue heating for 30min to degumme, obtaining degummed silk. (2) Rinsing: Take the degummed silk and rinse it in 5L of ultrapure water. Replace the water with an equal amount of ultrapure water, with an interval of 20min between each water change. Rinse 4 times to obtain rinsed degummed silk. (3) Drying: Take the rinsed degummed silk and spread it out to dry in a 30℃ environment for 72h to obtain degummed dried silk. (4) Dissolving silk fibers: Weigh 70g of degummed dry silk fibers, prepare a 0.977g / mL lithium bromide solution with 280ml of ultrapure water and 273.7g of lithium bromide. Dissolve the weighed degummed dry silk fibers in the lithium bromide solution and place it at 60℃ for 4h to obtain a silk fibroin lithium bromide solution. (5) Dialysis: Dispense the dissolved silk fibroin lithium bromide solution into 8kDa semipermeable membranes and place them in 5L of ultrapure water. Turn on the magnetic stirrer at 100r / min and change the water at 1h, 2h, 4h, 16h, 20h, and 24h. Collect the dialysis silk fibroin solution to obtain silk fibroin dialysate. (6) Centrifugation: Dispense the silk fibroin dialysate into a centrifuge and set the centrifugation speed to 12000r / min, centrifugation temperature to 5℃, and centrifugation time to 20min. Centrifuge and collect the supernatant to obtain a silk fibroin aqueous solution. (7) Freeze-drying: Place the centrifuged liquid in a -80℃ freezer for 4 hours, then put it into a vacuum freeze dryer, set the vacuum freeze dryer temperature to -40℃, freeze-dry for 72 hours, and take it out to obtain silk fibroin powder.

[0042] Example 1 Weigh 10g of silk fibroin powder and measure 60ml of hexafluoroisopropanol, place them in a container to dissolve, and seal the container with sealing film to obtain a silk fibroin hexafluoroisopropanol solution.

[0043] Prepare an appropriate amount of photoinitiator (Irgacure 5929) aqueous solution at a concentration of 0.3%, and add 30 ml of the photoinitiator aqueous solution to the above silk fibroin hexafluoroisopropanol solution. Stir well to obtain a mixed solution.

[0044] The above mixed solution was poured into a syringe and injected into the mold of the plate. After standing at 25°C for 3 days, the initial hydrogel was obtained by demolding.

[0045] The initial hydrogel was subjected to photocrosslinking treatment under ultraviolet light with a wavelength of 365 nm for 30 min to obtain a photocrosslinked hydrogel.

[0046] The above-mentioned photocrosslinked hydrogel was soaked in ultrapure water for 7 days, with fresh ultrapure water added daily. After soaking, it was removed and air-dried at room temperature for 20 days to obtain a photocrosslinked hydrogel board. The photocrosslinked hydrogel board was then mechanically processed into... Figure 2 The spinal fusion device shown.

[0047] Example 2 Weigh 10g of silk fibroin powder and measure 80ml of hexafluoroisopropanol, place them in a container to dissolve, and seal the container opening with sealing film to obtain silk fibroin hexafluoroisopropanol solution.

[0048] Prepare an appropriate amount of photoinitiator (Irgacure 5929) aqueous solution at a concentration of 0.3%, and add 30 ml of the photoinitiator aqueous solution to the above silk fibroin hexafluoroisopropanol solution. Stir well to obtain a mixed solution.

[0049] The above mixed solution was poured into a syringe and injected into the mold of the plate. After standing at 25°C for 3 days, the initial hydrogel was obtained by demolding.

[0050] The initial hydrogel was subjected to photocrosslinking treatment under ultraviolet light with a wavelength of 365 nm for 30 min to obtain a photocrosslinked hydrogel.

[0051] The above-mentioned photocrosslinked hydrogel was soaked in ultrapure water for 7 days, with fresh ultrapure water added daily. After soaking, it was removed and air-dried at room temperature for 20 days to obtain a photocrosslinked hydrogel board. The photocrosslinked hydrogel board was then mechanically processed into... Figure 2 The spinal fusion device shown.

[0052] Example 3 Weigh 10g of silk fibroin powder and measure 60ml of hexafluoroisopropanol, place them in a container to dissolve, and seal the container with sealing film to obtain a silk fibroin hexafluoroisopropanol solution.

[0053] Prepare an appropriate amount of photoinitiator (Irgacure 5929) aqueous solution at a concentration of 0.1%, and add 30 ml of the photoinitiator aqueous solution to the above silk fibroin hexafluoroisopropanol solution. Stir well to obtain a mixed solution.

[0054] The above mixed solution was poured into a syringe and injected into the mold of the plate. After standing at 25°C for 3 days, the initial hydrogel was obtained by demolding.

[0055] The initial hydrogel was subjected to photocrosslinking treatment under ultraviolet light with a wavelength of 365 nm for 30 min to obtain a photocrosslinked hydrogel.

[0056] The above-mentioned photocrosslinked hydrogel was soaked in ultrapure water for 7 days, with fresh ultrapure water added daily. After soaking, it was removed and air-dried at room temperature for 20 days to obtain a photocrosslinked hydrogel board. The photocrosslinked hydrogel board was then mechanically processed into... Figure 2 The spinal fusion device shown.

[0057] Example 4 Weigh 10g of silk fibroin powder and measure 60ml of hexafluoroisopropanol, place them in a container to dissolve, and seal the container with sealing film to obtain a silk fibroin hexafluoroisopropanol solution.

[0058] Prepare an appropriate amount of photoinitiator (Irgacure 5929) aqueous solution at a concentration of 0.3%, and add 30 ml of the photoinitiator aqueous solution to the above silk fibroin hexafluoroisopropanol solution. Stir well to obtain a mixed solution.

[0059] The above mixed solution was poured into a syringe and injected into the mold of the plate. After standing at 25°C for 3 days, the initial hydrogel was obtained by demolding.

[0060] The initial hydrogel was subjected to photocrosslinking treatment under ultraviolet light with a wavelength of 365 nm for 60 min to obtain a photocrosslinked hydrogel.

[0061] The above-mentioned photocrosslinked hydrogel was soaked in ultrapure water for 7 days, with fresh ultrapure water added daily. After soaking, it was removed and air-dried at room temperature for 20 days to obtain a photocrosslinked hydrogel board. The photocrosslinked hydrogel board was then mechanically processed into... Figure 2 The spinal fusion device shown.

[0062] Comparative Example 1 The difference from Example 1 is that 30ml of ultrapure water was added and mixed with silk fibroin hexafluoroisopropanol solution, and the mixture was directly soaked and dried without ultraviolet light irradiation to obtain the board.

[0063] Performance testing The plates obtained in Example 1 and Comparative Example 1 were subjected to bending resistance tests, and the test results are shown in Tables 1 and 2 below.

[0064] Table 1 Results of bending resistance test in Example 1

[0065] Table 2 Results of bending tests for Comparative Example 1

[0066] As shown in Tables 1 and 2, the material prepared in Example 1 has a flexural strength of 120–158 MPa, a flexural modulus of 8–12 GPa, and a deflection of 0.3–0.4 mm; the material prepared in Comparative Example 1 has a flexural strength of 51–70 MPa, a flexural modulus of 3–4 GPa, and a deflection of 0.3–0.5 mm. It is evident that the mechanical properties of Example 1 are superior to those of Comparative Example 1 and are closer to the biomechanical requirements of the human spine.

[0067] The foregoing description has fully disclosed the specific embodiments of the present invention. It should be noted that any modifications made to the specific embodiments of the present invention by those skilled in the art do not depart from the scope of the claims. Accordingly, the scope of the claims is not limited to the foregoing specific embodiments.

Claims

1. A method for preparing a spinal fusion device, characterized in that, The method includes: A silk fibroin hexafluoroisopropanol solution is provided; the ratio of silk fibroin powder to hexafluoroisopropanol in the silk fibroin hexafluoroisopropanol solution is 1g:(1~10)mL; After the silk fibroin hexafluoroisopropanol solution was mixed evenly with the photoinitiator aqueous solution, it was injected into a mold and allowed to stand and solidify to obtain the initial hydrogel. The initial hydrogel was subjected to photocrosslinking treatment under ultraviolet light to obtain a photocrosslinked hydrogel. The photocrosslinked hydrogel was sequentially soaked and dried to obtain a photocrosslinked hydrogel board. A spinal fusion device is obtained by mechanical processing based on the photocrosslinked hydrogel sheet.

2. The method for preparing the spinal fusion device according to claim 1, characterized in that, The step of sequentially soaking and drying the photocrosslinked hydrogel to obtain a photocrosslinked hydrogel board includes: The photocrosslinked hydrogel was soaked in ultrapure water for 5-10 days to obtain the soaked photocrosslinked hydrogel. The photocrosslinked hydrogel that has been soaked and washed is dried by air drying at room temperature to obtain the photocrosslinked hydrogel board.

3. The method for preparing the spinal fusion device according to claim 2, characterized in that, During the soaking process, freshly prepared ultrapure water is used daily; the air-drying time at room temperature is 1 to 30 days.

4. The method for preparing the spinal fusion device according to claim 1, characterized in that, The spinal fusion device obtained by mechanical processing based on the photocrosslinked hydrogel sheet includes: The photocrosslinked hydrogel sheet is integrally molded into a spinal fusion device; wherein the spinal fusion device includes a first fusion surface and a second fusion surface opposite to each other, and a bone graft window is formed in the spinal fusion device at a position away from the edge, penetrating the first fusion surface and the second fusion surface, and a plurality of fixation points for cooperating with tantalum metal rods are distributed around the periphery of the bone graft window.

5. The method for preparing the spinal fusion device according to claim 4, characterized in that, The first fusion surface and / or the second fusion surface are tooth surfaces.

6. The method for preparing the spinal fusion device according to any one of claims 1 to 5, characterized in that, The process of mixing the silk fibroin hexafluoroisopropanol solution with the photoinitiator aqueous solution, injecting the mixture into a mold, and allowing it to solidify to obtain the initial hydrogel includes: The photoinitiator aqueous solution is added to the silk fibroin hexafluoroisopropanol solution, mixed evenly, and then injected into a mold. The mixture is allowed to stand and solidify at a temperature of 5-40°C for 1-5 days to obtain the initial hydrogel.

7. The method for preparing the spinal fusion device according to claim 6, characterized in that, The concentration of the photoinitiator in the aqueous photoinitiator solution is 0.1-0.5%; the volume ratio of the silk fibroin hexafluoroisopropanol solution to the aqueous photoinitiator solution is 5:4-5:

1.

8. The method for preparing the spinal fusion device according to claim 1, characterized in that, The wavelength of the ultraviolet light irradiation is 254~365nm, and the irradiation duration is 10~60min.

9. A spinal fusion device, characterized in that, It is prepared by the method of any one of claims 1 to 8.

10. The spinal fusion device according to claim 9, characterized in that, The spinal fusion device includes a first fusion surface and a second fusion surface opposite to each other. The spinal fusion device has a bone graft window that penetrates the first fusion surface and the second fusion surface at a position away from the edge. Multiple fixation points for cooperating with tantalum metal rods are distributed around the periphery of the bone graft window. The first fusion surface and / or the second fusion surface are toothed surfaces.

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