Percutaneous sealing composite kirschner wire material with drug-loaded polymer embedded in surface groove and preparation method of percutaneous sealing composite kirschner wire material

Abstract

The invention discloses a percutaneous sealing composite kirschner wire material with a drug-loaded polymer embedded in a surface groove and a preparation method of the percutaneous sealing composite kirschner wire material. The preparation method specifically comprises the following steps: (1) firstly, taking a formed metal kirschner wire sample, and processing a groove structure on the surface of the formed metal kirschner wire sample in combination with a laser etching technology; (2) selecting a medicine capable of promoting epithelial tissue repair, and blending the medicine into the self-curing polymer double-component pre-solution; (3) rapidly coating the surface of a kirschner wire with the obtained drug-loaded polymer pre-solution, and curing and drying; (4) surface curing polymers are removed through a step-by-step sanding and polishing process, and the surface roughness of the polymers in the grooves is smaller than 0.8 micrometer; and 5) washing with ultrapure water, drying, packaging in vacuum, and carrying out irradiation sterilization to obtain the required percutaneous sealing composite kirschner wire material with the drug-loaded polymer embedded in the surface groove. The composite kirschner wire is rapid in drug release, has an efficient percutaneous sealing promoting function, and can solve the problem of wound infection of the kirschner wire.

Description

Technical Field

[0001] The invention relates to a bone implant device preparation technology, and in particular to a percutaneous sealing composite Kirschner wire material with a surface groove embedded with a drug-loaded polymer and a preparation method thereof. Background Art

[0002] Kirschner wire is a commonly used internal fixation material in orthopedics. It is used to fix fractures with low stress, such as short fractures or avulsion fractures. It is also used to fix temporary fracture fragments in orthopedic surgery. Due to its structural characteristics, part of the Kirschner wire is often exposed outside the skin during use, causing the Kirschner wire to show typical percutaneous characteristics. It is precisely this percutaneous characteristic that makes it very easy to get needle tract infection during use, delaying the patient's recovery period, and even causing irreversible effects on the patient.

[0003] In response to the above problems, the current clinical practice is to use alcohol or iodine to disinfect the needle tract frequently to reduce the incidence of infection. However, topical disinfectants can irritate the skin and the prevention effect is not ideal. For infections that have already occurred, the use of antibiotics will also be increased. However, since the needle tract is in direct contact with the outside world and bacteria can easily form biofilms on the surface of the Kirschner wire, the use of antibiotics is not effective. The key to solving the above problems is to achieve the purpose of percutaneous sealing by promoting the healing of epithelial tissue based on its percutaneous characteristics, so as to achieve direct contact between the needle tract and the outside world and isolate the source of bacteria.

[0004] Therefore, the present invention designs a percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers. By sequentially introducing a groove structure and drugs that promote epithelial tissue repair into the surface of a traditional Kirschner wire, it is endowed with an excellent and precise sealing function, thereby achieving efficient treatment of needle tract infection. Summary of the invention

[0005] The purpose of the present invention is to provide a composite Kirschner wire material with a surface groove embedded with a drug-loaded polymer and a preparation method thereof to solve the problem of poor percutaneous sealing of Kirschner wires of external fixation stents. The composite Kirschner wire releases drugs quickly and has a highly efficient percutaneous sealing function, which can solve the problem of Kirschner wire wound infection.

[0006] The present invention is implemented by the following technical solution, which specifically includes the following steps:

[0007] A method for preparing a percutaneous sealing composite Kirschner wire material with a surface groove embedded with a drug-loaded polymer comprises the following steps:

[0008] 1) Processing a plurality of groove structures on the surface of the Kirschner wire by combining laser etching;

[0009] 2) blending a drug that promotes epithelial tissue repair into one component of a two-component pre-solution of a self-curing polymer, and then freeze-drying and grinding the two components to obtain a blended powder consisting of a drug-loaded polymer powder and an initial polymer powder of the other component;

[0010] 3) dissolving and mixing the drug-loaded polymer powder and the initial polymer powder of the other component, freeze-drying and grinding into polymer powder; applying the powder to the surface of the Kirschner wire moistened with a PBS / ethanol mixed solution, spraying the PBS / ethanol mixed solution and applying the polymer powder alternately until the surface of the Kirschner wire is completely covered with the polymer powder, and then aging, curing and drying;

[0011] 4) using a step-by-step sanding and polishing process to remove the surface solidified polymer of the Kirschner wire and retain the solidified polymer in the groove;

[0012] 5) After polishing, the material is rinsed, dried, vacuum packaged, and irradiated for sterilization to obtain a percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers.

[0013] Furthermore, the diameter of the Kirschner wire in step 1) is greater than 3.0 mm;

[0014] During the laser etching process, the laser power is 40-80%, the laser pulse width is 50-120ns, the laser processing rate is 0.05-0.2m / s, the defocus distance is 0.01-2mm, the etching line width is 100-200 microns, the line width consistency is ≤10%, the scanning path is a straight line, and the same groove structure is etched until the depth reaches the standard, then the laser is stopped and the next groove structure is etched;

[0015] The plurality of groove structures are annular, with a groove width of 400-800 microns, a depth of 200-400 microns, a groove interval of 200-1000 microns, and 8-40 groove structures are axially arranged on each Kirschner wire.

[0016] Furthermore, in step 2), the drug for promoting epithelial tissue repair is one or more of eicosapentaenoic acid, curcumin, centella asiatica glycoside, lycium barbarum glycopeptide, and rhubarb polysaccharide, with a concentration of 5-20 mg / ml, and the solvent is a mixture of deionized water and ethanol, and the mixing volume ratio is deionized water: ethanol = 5:1-10:1;

[0017] The two components of the self-curing polymer two-component pre-solution are polyethyleneimine and polyacrylic acid. The drug promoting epithelial tissue repair is preferably mixed in the polyacrylic acid solution, and the concentration of the polyacrylic acid solution is 5-20wt%.

[0018] Furthermore, in step 3), the concentration ratio of polyethyleneimine to polyacrylic acid is 2:8-8:2, and the total concentration is 5-10 wt%;

[0019] The volume ratio of PBS to ethanol in the PBS / ethanol mixed solution is 3:1-1:3;

[0020] The aging time is 2-3h, and the temperature is 25-30°C;

[0021] The curing time is 2-3h, and the temperature is 37-45°C;

[0022] The drying time is 1-2 hours, and the temperature is 50-60°C.

[0023] Furthermore, in step 4), during the step-by-step sanding and polishing process, 100, 150 and 200 mesh grinding wheels are used for polishing in sequence, and the surface roughness of the solidified polymer in the groove is less than 0.8 micrometers.

[0024] Furthermore, in step 5), the rinsing is performed with ultrapure water for 2-3 times; and the drying is performed at 45° C. for 2-4 hours.

[0025] A percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers is obtained by using any of the above-mentioned preparation methods.

[0026] Compared with the prior art, the present invention has the following advantages:

[0027] 1) The present invention uses Kirschner wires, polyethyleneimine, polyacrylic acid, epithelial tissue repair promoting drugs, etc. as raw materials, and combines laser etching, freeze-drying grinding, blending, alternating spraying, step-by-step sanding and polishing to produce a percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers. The above raw material selection and process combination are original to the present invention.

[0028] 2) The present invention introduces percutaneous sealing performance on the basis of the traditional Kirschner wire by using a combined process of laser etching to introduce a groove structure + embedding a drug-loaded adhesive + step-by-step sanding and polishing, which is original to the present invention: first, a groove structure with specific parameters is introduced on the surface of the formed Kirschner wire using high-precision laser etching technology, providing a physical loading site for the subsequent introduction of drugs that promote epithelial tissue repair without affecting the mechanical strength of the Kirschner wire; then, an adhesive material that can adhere to water is used as a carrier for loading drugs on the surface of the Kirschner wire, and the drug-loaded adhesive is firmly "embedded" in the groove structure, and efficient drug loading is achieved through single adhesion and double mechanical occlusion; finally, the excess adhesive is removed using step-by-step sanding and polishing technology to obtain a smooth surface, so that the drug-loaded and the Kirschner wire matrix form a whole with the same outer surface, and the outer surface maintains a roughness of less than 0.8 microns, ensuring that the composite Kirschner wire can be smoothly inserted into the needle tract when in use, without causing more pain and psychological burden to the patient.

[0029] 3) In the present invention, the drug that promotes epithelial tissue repair is uniformly introduced into the adhesive by using the blended freeze-drying grinding technology, and the wet adhesion function of the adhesive is used as the core to successfully achieve the "embedding" of the drug in the groove structure on the surface of the Kirschner wire; and the aging and curing technology is used to make the adhesive form a shape similar to the properties of plastic, thereby forming a rigid overall structure with the Kirschner wire matrix to meet the processing requirements such as sanding; when in use, even in a body fluid environment, due to the wet adhesion function of the adhesive, it can be firmly adhered to the groove without falling off, and does not bring safety hazards. In the present invention, the applicant combined the actual scenario of the functional modification of the Kirschner wire and successfully prepared a new type of Kirschner wire material with efficient sealing function through the new application of the old process. It is precisely because of the organic synergy of the above-mentioned processes that the composite Kirschner wire can be successfully prepared.

[0030] 4) The composite Kirschner wire material in the present invention has both high bending strength and percutaneous sealing performance: first, the applicant selects a Kirschner wire with a diameter greater than 3.0 mm as a functionally modified substrate, which itself has a large diameter and excellent mechanical properties, and the mechanical properties will not be greatly reduced due to the introduction of a micron-level groove structure on its surface; secondly, the groove structure on the surface of the Kirschner wire is designed by the present invention in combination with mechanical simulation: the groove width is 400-800 microns, the depth is 200-400 microns, and the groove spacing is 500-1000 microns. On the one hand, the above structural parameters do not affect the bending strength of the substrate, and on the other hand, they can provide a suitable "embedded" physical site for the subsequent drug-loaded adhesive; finally, through the wet adhesion ability and water swelling performance of the adhesive, the efficient loading and short-cycle release of the drug that promotes epithelial tissue repair is achieved, thereby achieving the purpose of promoting needle tract healing, thereby blocking the needle tract from the external bacterial environment and solving the problem of Kirschner wire needle tract infection.

[0031] 5) The laser etching and drug-loaded adhesive inlay adhesion technology used in the present invention sequentially introduces a groove structure and a drug that promotes epithelial tissue repair into the Kirschner wire material, and can be applied to Kirschner wires of different specifications and models. The technology is universal and convenient. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 The present invention is a schematic diagram of the preparation process of the percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers. DETAILED DESCRIPTION

[0033] The technical solution of the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments. Figure 1 As shown, the axial direction of the Kirschner wire is taken as the transverse direction, and the longitudinal direction is perpendicular to the transverse direction.

[0034] Comparative Example 1:

[0035] 1) Selecting asiaticoside (concentration of 10 mg / ml), a drug that promotes epithelial tissue repair, blending it with a polyacrylic acid solution of a two-component pre-solution of a self-curing polymer (polyacrylic acid concentration of 10 wt %, solvent selection volume ratio of deionized water / ethanol of 5:1), and then freeze-drying and grinding it to obtain a blended powder;

[0036] 3) After the drug-loaded polyacrylic acid powder and polyethyleneimine powder are dissolved and mixed (the concentration ratio of polyethyleneimine to polyacrylic acid is 1:1, and the total concentration is 10wt%), freeze-dried and ground into powder, they are quickly coated on the surface of a Kirschner wire (diameter 4.0 mm) wetted in advance with a PBS / ethanol mixed solution, and the PBS / ethanol mixed solution and the polymer powder are sprayed alternately until the surface of the Kirschner wire is completely covered with the polymer, aged at 30°C for 2h; cured at 45°C for 3h; dried at 50°C for 60min; the volume ratio of PBS to ethanol in the PBS / ethanol mixed solution is 1:1;

[0037] 4) Use 100, 150 and 200 mesh grinding wheels to perform step-by-step sanding and polishing in sequence to keep the polymer on the surface of the Kirschner wire flat;

[0038] 5) The composite Kirschner wire material is obtained after rinsing with ultrapure water, drying, vacuum packaging and irradiation sterilization.

[0039] The extract of the above materials was cultured with endothelial cells, and the CCK-8 results showed that the cell survival rate was about 84% after 7 days. Rats were used as experimental subjects for external fixation animal experiments. When the composite Kirschner wire was implanted, the surface polymer coating fell off significantly, and the implantation effect was poor. Seven days after implantation, the repair effect of the epithelial tissue in the needle tract was general, and exudation still occurred.

[0040] Embodiment 1:

[0041] 1) First, a formed metal Kirschner wire sample with a diameter of 4.0 mm was taken, and a longitudinal groove structure with a specific shape (groove width of 400 microns, depth of 200 microns, and groove interval of 400 microns) was processed on its surface by combining laser etching technology (laser power of 60%, laser pulse width of 80 ns, laser processing rate of 0.1 m / s, defocus distance of 0.5 mm, etching line width of 200 microns, line width consistency of ≤10%, and scanning path of straight line) and after the etching of the groove structure was completed, the laser was stopped and the Kirschner wire was axially translated by the groove interval and then the next groove structure was etched until all the groove structures on the surface of the Kirschner wire were processed, and the number of groove structures was 15;

[0042] 2) Selecting asiaticoside (concentration of 10 mg / ml), a drug that promotes epithelial tissue repair, blending it into a polyacrylic acid solution of a two-component pre-solution of a self-curing polymer (polyacrylic acid concentration of 10 wt %, solvent selection volume ratio of deionized water / ethanol of 5:1), and then freeze-drying and grinding it to obtain a blended powder;

[0043] 3) After the drug-loaded polyacrylic acid powder and polyethyleneimine powder are dissolved and mixed (the concentration ratio of polyethyleneimine to polyacrylic acid is 1:1, and the total concentration is 10wt%), freeze-dried and ground into powder, they are quickly coated on the surface of the Kirschner wire wetted in advance with a PBS / ethanol mixed solution, and the PBS / ethanol mixed solution and the polymer powder are sprayed alternately until the surface of the Kirschner wire is completely covered with the polymer, aged at 30°C for 2h; cured at 45°C for 3h; dried at 50°C for 60min; the volume ratio of PBS to ethanol in the PBS / ethanol mixed solution is 1:1;

[0044] 4) using 100, 150 and 200 mesh grinding wheels to perform step-by-step sanding and polishing to remove the surface solidified polymer, and making the surface roughness of the polymer in the groove less than 0.8 microns;

[0045] 5) After rinsing with ultrapure water, drying, vacuum packaging and irradiation sterilization, a percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers is obtained.

[0046] Compared with Comparative Example 1, a groove structure is introduced on the surface of the Kirschner wire in this embodiment. The extract of the above material is cultured with endothelial cells, and the CCK-8 results after 7 days show that the cell survival rate is about 93%; using rats as experimental subjects, when conducting external fixation animal experiments, the surface embedded polymer coating of the composite Kirschner wire is basically not detached when implanted, and the epithelial tissue repair effect of the needle channel is obvious 7 days after implantation, and the needle channel achieves good healing and sealing. This is because the polymer embedded in the groove structure is shielded by the wear of the Kirschner wire body, and the groove structure area itself is small, so the loss of the drug-loaded polymer is small, and the needle channel repair effect is excellent.

[0047] Embodiment 2:

[0048] 1) First, a formed metal Kirschner wire sample with a diameter of 4.0 mm was taken, and a longitudinal groove structure with a specific shape (groove width of 400 microns, depth of 200 microns, and groove interval of 400 microns) was processed on its surface by combining laser etching technology (laser power of 60%, laser pulse width of 80 ns, laser processing rate of 0.1 m / s, defocus distance of 0.5 mm, etching line width of 200 microns, line width consistency of ≤10%, and scanning path of straight line) and after the etching of the groove structure was completed, the laser was stopped and the Kirschner wire was axially translated by the groove interval and then the next groove structure was etched until all the groove structures on the surface of the Kirschner wire were processed, and the number of groove structures was 15;

[0049] 2) Selecting asiaticoside (concentration of 10 mg / ml), a drug that promotes epithelial tissue repair, blending it into a polyacrylic acid solution of a two-component pre-solution of a self-curing polymer (polyacrylic acid concentration of 10 wt %, solvent selection volume ratio of deionized water / ethanol of 5:1), and then freeze-drying and grinding it to obtain a blended powder;

[0050] 3) After the drug-loaded polyacrylic acid powder and polyethyleneimine powder are dissolved and mixed (the concentration ratio of polyethyleneimine to polyacrylic acid is 1:1, and the total concentration is 6wt%), freeze-dried and ground into powder, they are quickly coated on the surface of the Kirschner wire wetted in advance with a PBS / ethanol mixed solution, and the PBS / ethanol mixed solution and the polymer powder are sprayed alternately until the surface of the Kirschner wire is completely covered with the polymer, aged at 30°C for 2h; cured at 45°C for 3h; dried at 50°C for 60min; the volume ratio of PBS to ethanol in the PBS / ethanol mixed solution is 1:1;

[0051] 4) using 100, 150 and 200 mesh grinding wheels to perform step-by-step sanding and polishing to remove the surface solidified polymer, and making the surface roughness of the polymer in the groove less than 0.8 microns;

[0052] 5) After rinsing with ultrapure water, drying, vacuum packaging and irradiation sterilization, a percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers is obtained.

[0053] Compared with Example 1, the total concentration of the adhesive is reduced. The extract of the above materials was cultured with endothelial cells, and the CCK-8 results showed that the cell survival rate was about 88% after 7 days. When rats were used as experimental subjects for external fixation animal experiments, the surface embedded polymer coating of the composite Kirschner wire was basically not shed when implanted. After 7 days of implantation, the repair effect of the epithelial tissue of the needle tract was obvious, and the healing and sealing rates of the needle tract were increased compared with Example 1. This is because the reduction in the concentration of the adhesive leads to faster diffusion of the internal drug in a short time, and the local concentration increases, which reduces the biocompatibility, but improves the effect of needle tract healing.

[0054] Embodiment 3:

[0055] 1) First, a formed metal Kirschner wire sample with a diameter of 4.0 mm was taken, and a longitudinal groove structure with a specific shape (groove width of 800 microns, depth of 400 microns, and groove interval of 400 microns) was processed on its surface by combining laser etching technology (laser power of 60%, laser pulse width of 80 ns, laser processing rate of 0.1 m / s, defocus distance of 0.5 mm, etching line width of 200 microns, line width consistency of ≤10%, and scanning path of straight line). After the etching of the groove structure was completed, the laser was stopped and the Kirschner wire was axially translated by the groove interval to start etching the next groove structure until all groove structures on the surface of the Kirschner wire were processed. The number of groove structures was 10;

[0056] 2) Selecting asiaticoside (concentration of 10 mg / ml), a drug that promotes epithelial tissue repair, blending it into a polyacrylic acid solution of a two-component pre-solution of a self-curing polymer (polyacrylic acid concentration of 10 wt %, solvent selection volume ratio of deionized water / ethanol of 5:1), and then freeze-drying and grinding it to obtain a blended powder;

[0057] 3) After the drug-loaded polyacrylic acid powder and polyethyleneimine powder are dissolved and mixed (the concentration ratio of polyethyleneimine to polyacrylic acid is 1:1, and the total concentration is 10wt%), freeze-dried and ground into powder, they are quickly coated on the surface of the Kirschner wire wetted in advance with a PBS / ethanol mixed solution, and the PBS / ethanol mixed solution and the polymer powder are sprayed alternately until the surface of the Kirschner wire is completely covered with the polymer, aged at 30°C for 2h; cured at 45°C for 3h; dried at 50°C for 60min; the volume ratio of PBS to ethanol in the PBS / ethanol mixed solution is 1:1;

[0058] 4) using 100, 150 and 200 mesh grinding wheels to perform step-by-step sanding and polishing to remove the surface solidified polymer, and making the surface roughness of the polymer in the groove less than 0.8 microns;

[0059] 5) After rinsing with ultrapure water, drying, vacuum packaging and irradiation sterilization, a percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers is obtained.

[0060] Compared with Example 1, the depth and width of the groove structure are increased in this embodiment. The extract of the above-mentioned material was cultured with endothelial cells, and the CCK-8 results after 7 days showed that the cell survival rate was about 91%; using rats as experimental subjects, when conducting external fixation animal experiments, the surface mosaic polymer coating of the composite Kirschner wire was basically slightly worn and slipped when implanted, and the repair effect of the epithelial tissue of the needle channel was acceptable after 7 days of implantation. This is because after the width of the groove is increased, the contact area with the bone is increased, and the physical shielding effect of the Kirschner wire body on the drug-loaded polymer in the groove is reduced, resulting in increased polymer wear.

Claims

1. A method for preparing a percutaneous sealing composite Kirschner wire material with a surface groove embedded with a drug-loaded polymer, characterized in that: The following steps are involved: 1) Processing a plurality of groove structures on the surface of the Kirschner wire by laser etching; 2) blending a drug that promotes epithelial tissue repair into one component of a two-component pre-solution of a self-curing polymer, and then freeze-drying and grinding the two components separately to obtain a drug-loaded polymer powder and an initial polymer powder of the other component; 3) dissolving and mixing the drug-loaded polymer powder and the initial polymer powder of the other component, freeze-drying and grinding into polymer powder; applying the powder to the surface of the Kirschner wire moistened with a PBS / ethanol mixed solution, spraying the PBS / ethanol mixed solution and applying the polymer powder alternately until the surface of the Kirschner wire is completely covered with the polymer powder, and then aging, curing and drying; 4) using a step-by-step sanding and polishing process to remove the surface solidified polymer of the Kirschner wire and retain the solidified polymer in the groove to control its surface roughness; 5) After polishing, the material is rinsed, dried, vacuum packaged, and irradiated for sterilization to obtain a percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers.

2. The method for preparing the percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers according to claim 1, characterized in that: The diameter of the Kirschner wire in step 1) is greater than 3.0 mm; During the laser etching process, the laser power is 40-80%, the laser pulse width is 50-120ns, the laser processing rate is 0.05-0.2m / s, the defocus distance is 0.01-2mm, the etching line width is 100-200 microns, the line width consistency is ≤10%, the scanning path is a straight line, and the same groove structure is etched until the depth reaches the standard, then the laser is stopped and the next groove structure is etched; The plurality of grooves are specifically: annular around the circumference of the Kirschner wire, with a groove width of 400-800 microns, a depth of 200-400 microns, a groove spacing of 200-1000 microns, and 8-40 groove structures are axially arranged on each Kirschner wire.

3. The method for preparing the percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers according to claim 1, characterized in that: In step 2), the two components of the self-curing polymer two-component pre-solution are polyethyleneimine and polyacrylic acid, respectively, with a concentration ratio of 2:8-8:2 and a total concentration of 5-10wt%; The drug for promoting epithelial tissue repair is one or more of eicosapentaenoic acid, curcumin, asiatica glycoside, lycium barbarum glycopeptide, and rhubarb polysaccharide, with a concentration of 5-20 mg / ml. The solvent is a mixture of deionized water and ethanol, and the mixing volume ratio is deionized water: ethanol = 5:1-10:

1.

4. The method for preparing the percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers according to claim 3, characterized in that: The drug for promoting epithelial tissue repair is mixed in a polyacrylic acid solution, and the concentration of the polyacrylic acid solution is 5-20wt%.

5. The method for preparing the percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers according to claim 1, characterized in that: In step 3), the concentration ratio of polyethyleneimine to polyacrylic acid is 2:8-8:2, and the total concentration is 5-10wt%; The volume ratio of PBS to ethanol in the PBS / ethanol mixed solution is 3:1-1:3; The aging time is 2-3h, and the temperature is 25-30°C; The curing time is 2-3h, and the temperature is 37-45°C; The drying time is 1-2 hours, and the temperature is 50-60°C.

6. The method for preparing the percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers according to claim 1, characterized in that: In step 4), during the step-by-step sanding and polishing process, 100, 150 and 200 mesh grinding wheels are used for polishing in sequence, and the surface roughness of the solidified polymer in the groove is less than 0.8 microns.

7. The method for preparing the percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers according to claim 1, characterized in that: In step 5), the rinsing is performed with ultrapure water for 2-3 times; and the drying is performed at 45° C. for 2-4 hours.

8. A percutaneous sealing composite Kirschner wire material with surface grooves embedded with drug-loaded polymers, characterized in that: The method is adopted as described in any one of claims 1 to 7.

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