Pedicle implant and preparation method thereof

Abstract

The present invention provides a pedicle implant and a preparation method thereof, wherein the pedicle implant comprises: an implant body, an inner hole is arranged inside the implant body, and a thread is arranged on the outer surface of the implant body; a first through hole is arranged on the implant body and communicated with the inner hole. The technical solution of the present application effectively solves the problem that the pedicle implant body is easy to loosen after implantation in the related art.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a pedicle implant and a preparation method thereof. Background Art

[0002] The pedicle implant body is the most commonly used internal fixation device and one of the most common implants in spinal surgery. The pedicle structure on both sides of the spine is the key structure that connects the vertebral body in front of the spine and the lamina and other accessories in the back. The pedicle implant body that penetrates the pedicle from the back of the spine into the vertebral body in front can keep the "front-middle-back" three columns of the spine in a mechanically stable state. After the pedicle implant body is implanted, the caudal side of the implant body implanted on each side is connected and fixed using an internal fixation rod, ultimately forming a stable internal fixation system.

[0003] In the related art, for patients with osteopenia and osteoporosis, the pedicle implant body is prone to loosening after implantation, which may lead to vertebral slippage and even loss of spinal deformity correction. Summary of the invention

[0004] The main purpose of the present invention is to provide a pedicle implant and a preparation method thereof, so as to solve the problem in the related art that the pedicle implant body is prone to loosening after implantation.

[0005] In order to achieve the above-mentioned purpose, according to one aspect of the present invention, a pedicle implant is provided, comprising: an implant body, an inner hole is arranged inside the implant body, and a thread is arranged on the outer surface of the implant body; a first through hole is arranged on the implant body and connected with the inner hole.

[0006] Furthermore, a plurality of recesses are formed between the implant body and the thread, and the number of first through holes is multiple, with each recess being provided with a first through hole.

[0007] Furthermore, a plurality of first through holes are arranged in each recess, and the plurality of first through holes in each recess are arranged at intervals.

[0008] Furthermore, the number of the first through holes in each recess is equal, and the centers of the multiple first through holes corresponding to the positions in the multiple recesses are on a straight line, and the straight line is parallel to the axis of the implant body.

[0009] Furthermore, the pedicle implant also includes a connecting section and a conical section, the connecting section and the conical section are located at the same end of the implant body, the connecting section is located between the implant body and the conical section, and a second through hole communicating with the inner hole is provided on the connecting section.

[0010] Furthermore, the surfaces of the thread, the connecting section and the conical section are all smooth.

[0011] Furthermore, the pedicle implant further comprises a microporous structure, the microporous structure is located at the bottom of the recess, and the first through hole is located on the microporous structure.

[0012] Furthermore, the porosity of the microporous structure is between 10% and 40%, the pore size of the microporous structure is between 100 μm and 500 μm, and the wire diameter of the microporous structure is between 200 μm and 500 μm.

[0013] Furthermore, the implant body is cylindrical, the diameter of the implant body is a, a≤12 mm, the diameter of the inner hole is b,

[0014] According to another aspect of the present invention, a method for preparing a pedicle implant is provided, which is used to prepare the above-mentioned pedicle implant, and the preparation method comprises the following steps: step S10: obtaining a pedicle implant blank; step S20: performing micro-arc oxidation treatment on the pedicle implant blank; step S30: performing hydrothermal treatment on the pedicle implant blank after the micro-arc oxidation treatment.

[0015] Further, in step S20, the step of performing micro-arc oxidation treatment includes: preparing an electrolyte containing biologically active substances of calcium and phosphorus, wherein the concentration of calcium is m, 0.3 mol / L≤m<0.8 mol / L, and the concentration of phosphorus is n, (0.05m+0.065) mol / L≤n<0.07 mol / L; adding a complexing agent to the electrolyte, wherein the concentration of the complexing agent is x, 4.35m≤x≤5m; placing the pedicle implant blank into the electrolyte, and under the condition that the temperature of the electrolyte is less than 5°C, , the pedicle implant is used as the anode and the stainless steel is used as the cathode for oxidation treatment, wherein the oxidation treatment voltage is between 300V and 400V, the output pulse frequency of the oxidation treatment power supply is between 300Hz and 600Hz, the pulse width of the oxidation treatment is between 10μs and 70μs, the peak current of the oxidation treatment is between 0 and 30A, and the oxidation time of the oxidation treatment is between 2 minutes and 4 minutes; the pedicle implant blank after micro-arc oxidation treatment is cleaned and dried with deionized water, and the drying temperature is between 50℃ and 80℃.

[0016] Further, in step S30, the hydrothermal treatment step includes: placing a sodium dihydrogen phosphate solution into a reactor, wherein the concentration of the sodium dihydrogen phosphate solution is between 0.001 mol / L and 0.03 mol / L; placing a pedicle implant blank into the reactor and positioned in the sodium dihydrogen phosphate solution; adding a sodium hydroxide solution to the sodium dihydrogen phosphate solution so that the pH value of the sodium dihydrogen phosphate solution is between 9 and 14; wherein the filling degree in the reactor is 30% to 45%, the hydrothermal treatment time is between 24 hours and 36 hours, and the temperature of the sodium dihydrogen phosphate solution is between 180°C and 220°C.

[0017] Furthermore, after step S30, the preparation method further comprises the following steps: step S40: ultrasonically cleaning the pedicle implant blank using deionized water for 3 to 5 minutes, followed by drying with cold air; step S50: sterilizing the pedicle implant after drying with cold air.

[0018] According to the technical solution of the present invention, an inner hole is provided inside the implant body, and a first through hole is provided on the surface of the implant body, and the first through hole is connected to the inner hole. After the pedicle implant is implanted into the patient's body, the pedicle implant contacts the patient's bone, and the bone can grow into the first through hole. At the same time, adding autologous bone, allogeneic bone or artificial bone to the inner hole during surgery can better enable the patient's bone to grow into the inner hole and combine with the bone structure in the inner hole, thereby achieving biological fixation. Therefore, the technical solution of the present application effectively solves the problem of the pedicle implant body in the related art being prone to loosening after implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0020] Figure 1 A schematic diagram of the three-dimensional structure of an embodiment of a pedicle implant according to the present invention is shown;

[0021] Figure 2 A schematic flow chart showing an embodiment of a method for preparing a pedicle implant according to the present invention;

[0022] Figure 3 Shows Figure 2 A schematic flow diagram of the micro-arc oxidation step of the preparation method; and

[0023] Figure 4 Shows Figure 2 Schematic diagram of the hydrothermal treatment steps of the preparation method.

[0024] The above drawings include the following reference numerals:

[0025] 10. implant body; 11. inner hole; 12. thread; 13. recess; 14. connecting section; 141. second through hole; 15. conical section; 20. through hole; 30. microporous structure. DETAILED DESCRIPTION

[0026] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. The following description of at least one exemplary embodiment is actually only illustrative and is by no means intended to limit the present invention and its application or use. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0028] Unless otherwise specifically stated, the relative arrangement of the parts and steps described in these embodiments, numerical expressions and numerical values ​​do not limit the scope of the present invention. At the same time, it should be understood that, for ease of description, the sizes of the various parts shown in the accompanying drawings are not drawn according to the actual proportional relationship. The technology, method and equipment known to ordinary technicians in the relevant field may not be discussed in detail, but in appropriate cases, the technology, method and equipment should be regarded as a part of the authorization specification. In all examples shown and discussed here, any specific value should be interpreted as being merely exemplary, rather than as a limitation. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters represent similar items in the following drawings, so once a certain item is defined in an accompanying drawing, it does not need to be further discussed in subsequent drawings.

[0029] In order to increase the stability of pedicle implants after implantation into the human body, Figure 1 As shown, in this embodiment, the pedicle implant includes: an implant body 10 and a first through hole 20. The implant body 10 is provided with an inner hole 11, and the outer surface of the implant body 10 is provided with a thread 12; the first through hole 20 is provided on the implant body 10 and communicated with the inner hole 11.

[0030] By applying the technical solution of this embodiment, an inner hole 11 is provided inside the implant body 10, and a first through hole 20 is provided on the surface of the implant body 10, and the first through hole 20 is connected with the inner hole 11. After the pedicle implant is implanted into the patient's body, the pedicle implant contacts the patient's bone, and the bone can grow into the first through hole 20. At the same time, adding autologous bone, allogeneic bone or artificial bone to the inner hole 11 during surgery can better enable the patient's bone to grow into the inner hole 11 and combine with the bone structure in the inner hole 11, thereby achieving biological fixation. Therefore, the technical solution of this embodiment effectively solves the problem of the pedicle implant body in the related art that it is easy to loosen after implantation.

[0031] Considering the thickness of the side wall of the pedicle implant, in order to enable faster biological fixation to the human bone structure. Figure 1 As shown, in this embodiment, a plurality of recesses 13 are formed between the implant body 10 and the thread 12, and a plurality of first through holes 20 are formed, each of which is provided with a first through hole 20. The arrangement of the thread 12 facilitates the implantation of the pedicle implant into the human body. After implantation, the pedicle implant contacts the human bone structure, and the first through hole 20 is arranged in the recess 13, so that the bone structure can grow more easily into the inner hole 11, which can shorten the time required for biological fixation.

[0032] like Figure 1 As shown, in this embodiment, the recess 13 includes a plurality of first through holes 20, each of which is provided with a plurality of first through holes 20, and the plurality of first through holes 20 in each recess 13 are arranged at intervals. The implant body 10 is provided with a plurality of first through holes 20, which can improve the fixation effect, and the structure of the first through holes 20 is simple and easy to set.

[0033] like Figure 1 As shown, in the present embodiment, the number of the first through holes 20 in each recess 13 is equal, and the centers of the multiple first through holes 20 corresponding to the positions in the multiple recesses 13 are on a straight line, and the straight line is parallel to the axis of the implant body 10. The arrangement of the first through holes 20 is simpler and convenient for processing. In the present embodiment, the number of the first through holes 20 in each recess 13 is 4. Of course, the number of the first through holes 20 in each recess 13 can be between 2 and 6. The centers of the first through holes 20 in the vertical direction are on the same straight line, so that the contact effect with the bone structure is better, further improving the fixation effect.

[0034] In an embodiment not shown in the figures, the number of the first through holes in the recessed portion gradually decreases from the bottom of the implant body to the top of the implant body.

[0035] In order to facilitate the implantation of pedicle implants, Figure 1As shown, in this embodiment, the pedicle implant also includes a connecting section 14 and a conical section 15, the connecting section 14 and the conical section 15 are located at the same end of the implant body 10, the connecting section 14 is located between the implant body 10 and the conical section 15, and the connecting section 14 is provided with a second through hole 141 connected to the inner hole 11. The setting of the conical section 15 facilitates the implantation of the pedicle implant into the human bone structure, making it more convenient and labor-saving for the doctor to perform the operation, and at the same time, it can facilitate the doctor to control the direction of the pedicle implant. At the same time, the human bone structure can also grow into the inner hole 11 through the second through hole 141.

[0036] like Figure 1 As shown, in this embodiment, the surfaces of the thread 12, the connecting section 14 and the conical section 15 are all smooth surfaces, which is convenient for doctors to implant, and the surface roughness of the thread 12 is Ra≤3.2.

[0037] like Figure 1 As shown, in this embodiment, a microporous structure 30 is also provided on the implant body 10, and the microporous structure 30 is located in the recess 13, and the first through hole 20 is located on the microporous structure 30. The setting of the microporous structure 30 further improves the fixing effect of the pedicle implant and the human bone structure, which is conducive to the rapid fusion of the bone structure and the pedicle implant. The bone structure can achieve simultaneous growth of the inside and outside of the pedicle implant, and the fusion strength and efficiency are significantly improved. Especially for patients with osteoporosis, fusion can be formed in the early stage of implantation, which improves the safety and effectiveness of the use of the pedicle implant. It can avoid the problem of loosening or falling off of the pedicle implant after implantation. The microporous structure 30 can provide an anchor point for bone growth, and the surface microporous structure effectively increases the specific surface area of ​​the implant, so that the pedicle implant can have the biological activity of bone induction and bone growth in the early stage of implantation, further improving the safety and effectiveness of the pedicle implant after implantation.

[0038] like Figure 1 As shown, in this embodiment, the porosity of the microporous structure 30 is between 10% and 40%, the pore size of the microporous structure 30 is between 100 μm and 500 μm, and the wire diameter of the microporous structure 30 is between 200 μm and 500 μm. The above-mentioned size design enables the bone structure to grow better into the microporous structure 30.

[0039] Considering the overall structural strength of the pedicle implant, Figure 1 As shown, in this embodiment, the implant body 10 is cylindrical, the diameter of the implant body 10 is a, a≤12 mm, and the diameter of the inner hole 11 is b. The diameter of the inner hole 11 is less than half the diameter of the implant body 10 . This arrangement can ensure the overall structural strength of the pedicle implant on the one hand, and on the other hand, can make the length of the through hole 20 appropriate so that the human bone structure can grow into the inner hole 11 faster.

[0040] The pedicle implant of the present embodiment has an inner hole, and the inner hole is filled with biomaterials such as autologous bone, allogeneic bone and artificial bone. And the surface of the pedicle implant is modified to have biological activity, and the bone tissue can quickly achieve bony integration with the pedicle implant after implantation. The autologous bone or artificial bone in the inner hole is fused with the bone tissue grown into the outer surface of the implant, so that the pedicle implant and the host bone are integrated. The bone fusion state finally formed can achieve the effect of effectively preventing the loosening, degeneration and dislocation of the fusion type spinal internal fixation screw for a long time, especially in osteoporotic bone tissue, it can quickly and effectively realize the bony fusion device, realize effective fixation, and have more safety and effectiveness. The pedicle implant of the present embodiment can be formed by 3D printing, and formed into a thread by machining. The microporous structure can also be formed by 3D printing, which is a trabecular structure. Of course, it can also be an amorphous hole structure, a cubic structure, a hexagonal prism structure, a diamond structure, a rhombic dodecahedron structure, and a truncated octahedron structure. The holes in the microporous structure are manufactured by laser stereolithography, and can also be manufactured by one or more of selective laser sintering, melting and electron beam melting technologies. The material of the pedicle implant is titanium alloy, specifically Ti-6Al-4V, and can also be one of Ti-6Al-17Nb, Ti-13Nb-13Zr or Ti-5Zr-3Mo-15Nb.

[0041] like Figure 2As shown, according to another aspect of the present embodiment, a method for preparing a pedicle implant is provided, which is used to prepare the above-mentioned pedicle implant, and the preparation method comprises the following steps: step S10: obtaining a pedicle implant blank; step S20: micro-arc oxidation treatment of the pedicle implant blank; step S30: hydrothermal treatment of the pedicle implant blank after micro-arc oxidation treatment. The pedicle implant prepared by the above steps can make the surface of the pedicle implant evenly covered with bioactive substances, that is, the surface and smooth surface of the microporous structure are evenly covered with bioactive substances, so that the pedicle implant can grow better with the bone structure, ensuring the fixation effect of the pedicle implant. In step S10, the pedicle implant blank is immersed in an acetone solution and ultrasonically cleaned for 10 minutes. Of course, the cleaning time can be between 5 and 15 minutes. After cleaning, it is dried, and the drying temperature is 50°C. Through the above steps, the microporous structure and smooth surface of the surface of the pedicle implant can be uniformly filmed at the same time, the film thickness is controllable, and the calcium and phosphorus content in the film is stable. It can quickly realize industrial application, significantly reducing the implementation cost and implementation cycle. The film thickness of the smooth surface of the pedicle implant of this embodiment is about 12.8μm, the film thickness of the microporous surface is about 12.5μm, and the overall film thickness of the pedicle implant is uniform. Because the pedicle implant is subjected to micro-arc oxidation and hydrothermal treatment, the surface of the pedicle implant contains calcium and phosphorus, and has bioactive substances, which can make the implant fuse with bone tissue faster after implantation.

[0042] like Figure 3As shown, in step S20, the step of performing micro-arc oxidation treatment includes: preparing an electrolyte containing biologically active substances of calcium and phosphorus, wherein the concentration of calcium is m, 0.3 mol / L≤m<0.8 mol / L, and the concentration of phosphorus is n, (0.05m+0.065)mol / L≤n<0.07 mol / L; adding a complexing agent to the electrolyte, wherein the concentration of the complexing agent is x, 4.35m≤x≤5m; placing the pedicle implant blank into the electrolyte, and when the temperature of the electrolyte is less than 5°C, The pedicle implant is used as the anode and the stainless steel is used as the cathode for oxidation treatment, wherein the voltage of the oxidation treatment is between 300V and 400V, the output pulse frequency of the power supply of the oxidation treatment is between 300Hz and 600Hz, the pulse width of the oxidation treatment is between 10μs and 70μs, the peak current of the oxidation treatment is between 0 and 30A, and the oxidation time of the oxidation treatment is between 2 minutes and 4 minutes; the pedicle implant blank after micro-arc oxidation treatment is cleaned and dried with deionized water, and the drying temperature is between 50°C and 80°C. Through the above steps, a film layer with biologically active functions can be formed on the surface of the pedicle implant blank. In this embodiment, the calcium element is selected from calcium acetate, and of course one or more of calcium dihydrogen phosphate, calcium glycerophosphate, calcium citrate, calcium lactate and calcium oxide can also be selected. The phosphorus element is selected from sodium β-glycerophosphate, and of course one or more of sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium hexametaphosphate and sodium polyphosphate can also be selected. The above process parameters are optimized and verified by multiple experiments, and the range is selected to ensure uniform oxidation and good oxidation quality. Meanwhile, the above-mentioned complexing agent is EDTA-2Na. After micro-arc oxidation treatment, a titanium dioxide film layer containing bioactive elements of calcium and phosphorus is formed on the surface of the pedicle implant embryo, and the thickness of the film layer is between 10 μm and 15 μm.

[0043] The inventor found that the Ca / P ratio in the composition of hydroxyapatite is 1.67, and the calcium-phosphorus content contained in the pedicle implant after surface treatment is as close to this ratio as possible. In order to make the calcium-phosphorus content as close to the above ratio as possible, the technical solution of the present application determines the interval range of the Ca element, and according to multiple verification tests, the concentration range of the P element is optimized. After surface treatment, the Ca / P content and the corresponding ratio on the surface of the pedicle implant are guaranteed.

[0044] After a large number of experiments, the inventors found that when the concentration of calcium is less than 0.3 mol / L, the thickness of the film on the smooth surface is 11.3 μm, and the thickness of the film on the microporous surface is 6.8 μm; when the concentration of calcium is greater than 0.8 mol / L, the thickness of the film on the smooth surface is 24.1 μm, and the thickness of the film on the microporous surface is 12.6 μm.

[0045] like Figure 4As shown, in step S30, the hydrothermal treatment step includes: placing a sodium dihydrogen phosphate solution into a reactor, wherein the concentration of the sodium dihydrogen phosphate solution is between 0.001 mol / L and 0.03 mol / L; placing a pedicle implant blank into the reactor and being located in the sodium dihydrogen phosphate solution; adding a sodium hydroxide solution to the sodium dihydrogen phosphate solution so that the pH value of the sodium dihydrogen phosphate solution is between 9 and 14, preferably 11; wherein the filling degree in the reactor is 30% to 45%, preferably 38%, the hydrothermal treatment time is between 24 hours and 36 hours, and the temperature of the sodium dihydrogen phosphate solution is between 180°C and 220°C. The above-mentioned hydrothermal treatment time and the temperature of the sodium dihydrogen phosphate solution need to be specifically set according to the time situation.

[0046] like Figure 2 As shown, after step S30, the preparation method further includes the following steps: step S40: ultrasonically clean the pedicle implant blank with deionized water for a cleaning time of between 3 minutes and 5 minutes, and then blow dry with cold air; step S50: sterilize the pedicle implant after cold air drying. After the above steps, the surface layer of the membrane layer is formed into a microporous structure, in which the calcium atom (Ca) content is 6.0at.%≤Ca<8at.%, and the phosphorus atom (P) content is 1.0at.%≤P<5at.%, and the above at.% refers to the atomic percentage. The sterilization treatment adopts cobalt-60 irradiation sterilization, and the sterilization effect is better. The temperature range of the above cold air is less than or equal to 25°C.

[0047] In the description of the present invention, it is necessary to understand that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "lateral, vertical, perpendicular, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the drawings. They are only for the convenience of describing the present invention and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the devices or elements referred to must have a specific direction or be constructed and operated in a specific direction. Therefore, they cannot be understood as limiting the scope of protection of the present invention. The directional words "inside and outside" refer to the inside and outside relative to the contours of each component itself.

[0048] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below other devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0049] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. If not otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of the present invention.

[0050] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A method for preparing a pedicle implant, characterized in that: For preparing pedicle implants, the preparation method The steps include: Step S10: obtaining a pedicle implant blank; Step S20: performing micro-arc oxidation treatment on the pedicle implant blank; Step S30: performing hydrothermal treatment on the pedicle implant blank after the micro-arc oxidation treatment; In step S20, the steps of performing the micro-arc oxidation treatment include: An electrolyte containing biologically active substances of calcium and phosphorus is prepared, wherein the concentration of the calcium is m, 0.3mol / L≤m<0.8mol / L, the concentration of the phosphorus element is n, (0.05m+0.065)mol / L≤n<0.07mol / L; Adding a complexing agent to the electrolyte, wherein the concentration of the complexing agent is x, 4.35m≤x≤5m; The pedicle implant blank is placed in the electrolyte, and when the temperature of the electrolyte is less than 5° C., the pedicle implant is used as an anode and the stainless steel is used as a cathode for oxidation treatment, wherein the voltage of the oxidation treatment is between 300 V and 400 V, the output pulse frequency of the power supply of the oxidation treatment is between 300 Hz and 600 Hz, the pulse width of the oxidation treatment is between 10 μs and 70 μs, the peak current of the oxidation treatment is between 0 and 30 A, and the oxidation time of the oxidation treatment is between 2 minutes and 4 minutes; Using deionized water to clean and dry the pedicle implant blank after the micro-arc oxidation treatment, the drying temperature is between 50° C. and 80° C.; In the step S30, the hydrothermal treatment step includes: Putting a sodium dihydrogen phosphate solution into a reaction kettle, wherein the concentration of the sodium dihydrogen phosphate solution is between 0.001 mol / L and 0.03 mol / L; placing the pedicle implant blank into the reactor and placing it in the sodium dihydrogen phosphate solution; Adding sodium hydroxide solution to the sodium dihydrogen phosphate solution so that the pH value of the sodium dihydrogen phosphate solution is between 9 and 14; The filling degree of the reactor is 30% to 45%, the time of the hydrothermal treatment is between 24 hours and 36 hours, and the temperature of the sodium dihydrogen phosphate solution is between 180° C. and 220° C.; The pedicle implant comprises: An implant body (10), wherein an inner hole (11) is arranged inside the implant body (10), and a thread (12) is arranged on the outer surface of the implant body (10); A first through hole (20), the first through hole (20) being arranged on the implant body (10) and communicating with the inner hole (11); A plurality of recesses (13) are formed between the implant body (10) and the thread (12), and a plurality of first through holes (20) are provided, each of the recesses (13) having a first through hole (20).

2. The preparation method according to claim 1, characterized in that: After step S30, the preparation method further comprises the following steps: Step S40: using deionized water to ultrasonically clean the pedicle implant blank for 3 to 5 minutes, and then drying it with cold air; Step S50: sterilizing the pedicle implant after being dried by cold air.

3. The preparation method according to claim 1, characterized in that: A plurality of the first through holes (20) are arranged in each of the recesses (13), and the plurality of the first through holes (20) in each of the recesses (13) are arranged at intervals.

4. The preparation method according to claim 2, characterized in that: The number of the first through holes (20) in each of the recesses (13) is equal, and the centers of the multiple first through holes (20) corresponding to the positions in the multiple recesses (13) are on a straight line, and the straight line is parallel to the axis of the implant body (10).

5. The preparation method according to claim 1, characterized in that: The pedicle implant also includes a connecting section (14) and a conical section (15), wherein the connecting section (14) and the conical section (15) are located at the same end of the implant body (10), the connecting section (14) is located between the implant body (10) and the conical section (15), and the connecting section (14) is provided with a second through hole (141) connected to the inner hole (11).

6. The preparation method according to claim 5, characterized in that: The surfaces of the thread (12), the connecting section (14) and the conical section (15) are all smooth surfaces.

7. The preparation method according to claim 2, characterized in that: The pedicle implant further comprises a microporous structure (30), wherein the microporous structure (30) is located at the bottom of the recess (13), and the first through hole (20) is located on the microporous structure (30).

8. The preparation method according to claim 7, characterized in that: The porosity of the microporous structure (30) is between 10% and 40%, the pore size of the microporous structure (30) is between 100 μm and 500 μm, and the wire diameter of the microporous structure (30) is between 200 μm and 500 μm.

9. The preparation method according to claim 1, characterized in that: The implant body (10) is cylindrical, the diameter of the implant body (10) is a, a≤12 mm, the diameter of the inner hole (11) is b,

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