Malt-type acupuncture needle based on new material

Abstract

The invention provides a malt type acupuncture needle based on a new material. The 316 stainless steel wires are selected as raw materials, and the 316 stainless steel wires are medical-grade materials containing molybdenum elements and have good biocompatibility, corrosion resistance and mechanical strength. Although the 316 stainless steel wire contains molybdenum, the performance can be improved by adjusting the molybdenum content. A molybdenum-rich protective layer is formed on the surface of the acupuncture needle through a chemical vapor deposition (CVD) technology, so that the corrosion resistance of the acupuncture needle is further improved. Besides, according to the malt-type acupuncture needle prepared by the invention, a painless needle tip is formed by adopting a modern cutting process and reserving a manual multi-grinding process of a traditional acupuncture needle, so that the friction force and tissue damage during insertion are reduced, and the pain of a patient is greatly relieved. Meanwhile, the malt-shaped acupuncture needle designed by the invention can effectively solve the problems of safety and sanitation during clinical operation of a conventional acupuncture needle, and the therapeutic effect of acupuncture is enhanced.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices and relates to a malt-type acupuncture needle, and in particular to a malt-type acupuncture needle based on a new material. Background Art

[0002] Acupuncture is an important part of traditional Chinese medicine and has a history of thousands of years. Acupuncture therapy regulates qi and blood, balances yin and yang, and achieves the purpose of preventing and treating diseases by applying acupuncture to specific acupuncture points on the human body. As the core tool of this therapy, the quality and performance of acupuncture needles are crucial to ensure the treatment effect. Acupuncture is a unique means of treating diseases in China, which has been used since ancient times. Looking back on the development history of acupuncture medicine in the past century, acupuncture tools have gradually evolved from the most primitive stone needles and needles to gold needles, silver needles, and horse-bite iron needles. Now stainless steel is the most commonly used needle material in clinical practice. Acupuncture is an invasive treatment method. Factors such as lax disinfection measures, unclean treatment environment, or imperfect immune system of the patient can cause the spread of pathogens and cause bacterial infection. With the advancement of modern science and technology, the manufacturing process of acupuncture needles is also constantly developing and improving. Modern acupuncture needles are usually made of high-quality stainless steel, which has good biocompatibility, corrosion resistance and mechanical strength. 304 and 316 stainless steel are the most commonly used materials. 316 stainless steel wire has better corrosion resistance due to the addition of molybdenum, especially in chloride environments, so it is more common in the medical field. The manufacturing process of acupuncture needles is strictly controlled to ensure the sharpness of the needle tip, the straightness of the needle body, and the firmness of the needle handle.

[0003] In recent years, with the development of nanotechnology and new materials science, the research and development of acupuncture needles has also made new breakthroughs. Some new acupuncture needles use nanostructured materials to improve the hardness and sharpness of the needles and reduce the pain during acupuncture. The needle tip is one of the most important parts of an acupuncture needle, and its design directly affects the comfort and safety during acupuncture. The needle tips of modern acupuncture needles are usually designed to be very sharp to reduce trauma to the skin and tissues. The shapes of the needle tips are varied, and the most common ones are conical, beveled, etc. Each shape has its own unique advantages.

[0004] In order to improve the performance of acupuncture needles and reduce skin pain, the present invention proposes a malt-shaped acupuncture needle based on a new material. The malt-shaped acupuncture needle distributes force more evenly, thereby penetrating the skin more easily and reducing tissue damage. Summary of the invention

[0005] In view of the above problems, the present invention provides a malt-shaped acupuncture needle based on a new material. The present invention adds a molybdenum layer to the surface of 316 stainless steel wire, which not only increases the corrosion resistance and stability of the acupuncture needle in various environments, but also enhances the surface hardness and wear resistance through the columnar morphology perpendicular to the surface of the substrate. The present invention provides a malt-shaped acupuncture needle based on a new material, and the specific preparation steps are as follows:

[0006] S1. Clean the 316 stainless steel wires with specifications of 0.1-0.5mm and 0.2-0.6mm, put the cleaned 316 stainless steel wires into an annealing furnace, introduce N2, and then heat to 850℃ at a rate of 5℃ / min, keep warm for 1-3min and cool naturally. The filaments with a diameter of 0.1-0.5mm are acupuncture needle blanks, and the other filaments with a diameter of 0.2-0.6mm are needle handle blanks. The main purpose of annealing stainless steel wires is to improve their mechanical properties, eliminate internal stress, reduce hardness, improve plasticity, and prepare for subsequent processing.

[0007] S2. Place a 10-cm-long acupuncture needle blank and a 10-cm-long needle handle blank into a CVD reaction chamber, Ar is the protective gas, H2 is introduced at a rate of 1.0-1.2 L / min, MoF6 is 0.8-1.5 g / min, the deposition temperature is 800°C, the deposition time is 20 min, and then the temperature is reduced to 500°C, and the deposition time is 5 min; molybdenum has the advantages of high melting point, good electrical and thermal conductivity, low thermal expansion coefficient, excellent corrosion resistance and high-temperature mechanical properties. The molybdenum layer added to the surface of stainless steel not only makes it have better corrosion resistance and stability in various environments, but also has suitable hardness for manufacturing medical devices. This step adopts the method of controlling the reaction temperature to prepare a molybdenum coating with a needle-like morphology perpendicular to the surface of the substrate, so that the bonding strength of the molybdenum coating and stainless steel is significantly improved, and the corrosion resistance and wear resistance of the blank surface are significantly enhanced.

[0008] S3, bend the needle handle blank after deposition in step S2 into a circular spiral needle handle, and the needle handle length l1 is 35-65mm; then cut the deposited acupuncture needle blank in step S2 into a needle body with a length l2 of 30-55mm, and the needle body diameter d is 0.10-0.5mm, and the needle tip of the cut needle body is cut into a malt-type needle tip with a tangent angle α of 45°-50° by a fine grinding process, and the ratio of the needle tip length l3 of the needle tip to the needle body diameter d is 2:1; use laser welding to melt and connect the needle handle and the other end of the needle tip of the needle body together, and then put it into a centrifuge tube containing a detergent, and rotate it at a speed of 10000-30000r / min for 4-5min to obtain a malt-type acupuncture needle with surface impurities removed. The malt-type acupuncture needle needle can penetrate the skin more easily, reduce damage to cells, and thus reduce pain. And the malt-type needle tip helps to reduce friction and tissue damage during insertion, thereby greatly alleviating the patient's pain.

[0009] Among them, 316 stainless steel wire (specifications: diameter 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm) was purchased from Dongguan Haoyue Metal Materials Co., Ltd., and MoF6 was purchased from Hubei Wei's Chemical Reagent Co., Ltd.

[0010] Preferably: in step S1, 316 stainless steel wires with specifications of 0.1 mm and 0.2 mm are cleaned;

[0011] Preferably: in step S1, the temperature is kept for 1 minute and then cooled naturally;

[0012] Preferably: in step S2, the MoF6 is 0.8 g / min;

[0013] Preferably: in step S2, H2 is introduced at a rate of 1.0 L / min;

[0014] Preferably: in step S3, the length of the needle handle is 35 mm;

[0015] Preferably: in step S3, the acupuncture needle blank is cut into a malt-shaped needle tip 3 with a tangent angle of 45°;

[0016] Preferably: in step S3, the malt-shaped acupuncture needle with surface impurities removed is rotated at a speed of 10000 r / min for 4 min;

[0017] Preferably: the cleaning agent in step S3 is JX-401 cleaning agent, which is purchased from Jiexin Cleaning Agent Technology Co., Ltd.

[0018] Due to the adoption of the above technical solution, the technical progress achieved by the present invention is:

[0019] 1. The present invention further forms a protective layer rich in molybdenum on the surface of the 316 containing molybdenum by chemical vapor deposition (CVD) technology, which not only makes the acupuncture needle have better corrosion resistance and stability in various environments, but also has suitable hardness for manufacturing medical devices.

[0020] 2. The present invention prepares a molybdenum protective layer with a columnar morphology perpendicular to the surface of the substrate by controlling the reaction temperature, so that the bonding strength between the molybdenum coating and the stainless steel is significantly improved, and the corrosion resistance and wear resistance of the blank surface are significantly enhanced.

[0021] 3. The present invention provides a malt-shaped acupuncture needle based on a new material. The malt-shaped acupuncture needle can penetrate the skin more easily, reduce damage to cells, and thus reduce pain. And the malt-shaped needle helps to reduce friction and tissue damage during insertion, thereby greatly alleviating the patient's pain. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0023] Figure 1 This is a schematic diagram of a malt-type acupuncture needle of the present invention;

[0024] Among them, 1 is the needle handle, 2 is the needle body, 3 is the needle tip, l1 is the needle handle length, and l2 is the needle body length;

[0025] Figure 2 Schematic diagram of the malt-type acupuncture needle of the present invention; the left figure is a schematic diagram of the tangent angle of the needle tip of the needle, and the right figure is a schematic diagram of the needle; wherein α is the tangent angle, l3 is the needle tip length, and d is the needle body diameter;

[0026] Figure 3 Schematic diagram of a common acupuncture needle on the market in Example 9; the left figure is a schematic diagram of the tangent angle of the needle tip of the needle, and the right figure is a schematic diagram of the needle; wherein, β, tangent angle, l3′, needle tip length, d′, needle body diameter;

[0027] Figure 4 This is a scanning electron microscope image of a molybdenum layer deposited on a stainless steel surface in Example 1 of the present invention;

[0028] Figure 5 This is a scanning electron microscope image of a molybdenum layer deposited on a stainless steel surface in Comparative Example 1 of the present invention;

[0029] Figure 6This is a scanning electron microscope image of the molybdenum layer deposited on the surface of stainless steel in Comparative Example 2 of the present invention. DETAILED DESCRIPTION

[0030] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the content of the present invention and are not used to limit the present invention.

[0031] Example 1

[0032] S1. Clean the 316 stainless steel wires with specifications of 0.1mm and 0.2mm, put them into the annealing furnace, introduce N2, and then heat them to 850℃ at a rate of 5℃ / min. Keep them warm for 1min and then cool them naturally. The 0.1mm diameter filaments are used as acupuncture needle blanks, and the other 0.2mm diameter filaments are used as needle handle blanks. The main purpose of annealing stainless steel wire is to improve its mechanical properties, eliminate internal stress, reduce hardness, improve plasticity, and prepare for subsequent processing.

[0033] S2. Place a 10-cm-long acupuncture needle blank and a 10-cm-long needle handle blank into a CVD reaction chamber, Ar is the protective gas, H2 is introduced at a rate of 1.0 L / min, MoF6 is 0.8 g / min, the deposition temperature is 800°C, the deposition time is 20 min, and then the temperature is reduced to 500°C, and the deposition time is 5 min; molybdenum has the advantages of high melting point, good electrical and thermal conductivity, low thermal expansion coefficient, excellent corrosion resistance and high-temperature mechanical properties. The molybdenum layer added to the surface of stainless steel not only makes it have better corrosion resistance and stability in various environments, but also has suitable hardness for manufacturing medical devices. This step adopts the method of controlling the reaction temperature to prepare a molybdenum coating with a needle-like morphology perpendicular to the surface of the substrate, so that the bonding strength of the molybdenum coating and stainless steel is significantly improved, and the corrosion resistance and wear resistance of the blank surface are significantly enhanced.

[0034] S3, bend the needle handle blank after deposition in step S2 into a ring-shaped spiral needle handle, and the needle handle length l1 is 35mm; then cut the deposited acupuncture needle blank in step S2 into a needle body with a length l2 of 30mm and a needle body diameter d of 0.10mm, and cut the needle tip of the cut needle body into a malt-shaped needle tip with a tangent angle α of 42° through a fine grinding process, and the ratio of the needle tip length l3 of the needle tip to the needle body diameter d is 2:1; use laser welding to melt and connect the needle handle and the other end of the needle tip of the needle body together, and then put it into a centrifuge tube containing a detergent, and rotate it at a speed of 10000r / min for 4min to obtain a malt-shaped acupuncture needle with surface impurities removed. This malt-shaped acupuncture needle can penetrate the skin more easily, reduce damage to cells, and thus reduce pain. And the malt-shaped needle helps to reduce friction and tissue damage during insertion, thereby greatly alleviating the patient's pain.

[0035] Comparative Example 1: Except that in step S2, H2 is introduced at a rate of 1.0 L / min, MoF6 is 0.8 g / min, the deposition temperature is 800°C, and the deposition time is 25 min, the rest is the same as Example 1.

[0036] Comparative Example 2: Except that in step S2, H2 is introduced at a rate of 1.0 L / min, MoF6 is 0.8 g / min, the deposition temperature is 500°C, and the deposition time is 25 min, the rest is the same as Example 1.

[0037] Figures 4 to 6 The scanning electron microscope images of the molybdenum layer deposited on the stainless steel surface of Example 1 of the present invention and Comparative Examples 1-2 are respectively shown. When other conditions remain unchanged, the calcination temperature of the vapor deposition operation is changed. As a result, it is found that the molybdenum layer morphology obtained by Example 1 in two temperature stages is neat and uniform in needle shape. However, after the calcination temperatures of Comparative Examples 1-2 were changed, the surface morphology of Comparative Example 1 was chaotic, and Comparative Example 2 formed an irregular flaky morphology. It can be seen from the above that the present invention prepares a molybdenum coating with a needle-like morphology perpendicular to the surface of the substrate by controlling the reaction temperature.

[0038] Example 2

[0039] S1. Clean the 316 stainless steel wires with specifications of 0.3mm and 0.4mm, put them into the annealing furnace, introduce N2, and then heat them to 850℃ at a rate of 5℃ / min. Keep them warm for 2 minutes and then cool them naturally. The 0.3mm diameter filaments are used as acupuncture needle blanks, and the other 0.4mm diameter filaments are used as needle handle blanks. The main purpose of annealing stainless steel wire is to improve its mechanical properties, eliminate internal stress, reduce hardness, improve plasticity, and prepare for subsequent processing.

[0040] S2. Place a 10-cm-long acupuncture needle blank and a 10-cm-long needle handle blank into a CVD reaction chamber, Ar is the protective gas, H2 is introduced at a rate of 1.1 L / min, MoF6 is 1 g / min, the deposition temperature is 800°C, the deposition time is 20 min, and then the temperature is reduced to 500°C, and the deposition time is 5 min; molybdenum has the advantages of high melting point, good electrical and thermal conductivity, low thermal expansion coefficient, excellent corrosion resistance and high-temperature mechanical properties. The molybdenum layer added to the surface of stainless steel not only makes it have better corrosion resistance and stability in various environments, but also has suitable hardness for manufacturing medical devices. This step adopts the method of controlling the reaction temperature to prepare a molybdenum coating with a needle-like morphology perpendicular to the surface of the substrate, so that the bonding strength of the molybdenum coating and stainless steel is significantly improved, and the corrosion resistance and wear resistance of the blank surface are significantly enhanced.

[0041] S3, bend the needle handle blank after deposition in step S2 into a ring-shaped spiral needle handle, and the needle handle length l1 is 40mm; then cut the deposited acupuncture needle blank in step S2 into a needle body with a length l2 of 50mm and a needle body diameter d of 0.3mm, and cut the needle tip of the cut needle body into a malt-shaped needle tip with a tangent angle α of 48° through a fine grinding process, and the ratio of the needle tip length l3 of the needle tip to the needle body diameter d is 2:1; use laser welding to melt and connect the needle handle and the other end of the needle tip of the needle body together, and then put it into a centrifuge tube containing a detergent, and rotate it at a speed of 20000r / min for 5min to obtain a malt-shaped acupuncture needle with surface impurities removed. The malt-shaped acupuncture needle needle can penetrate the skin more easily, reduce damage to cells, and thus reduce pain. And the malt-shaped needle tip helps to reduce friction and tissue damage during insertion, thereby greatly alleviating the patient's pain.

[0042] Comparative Example 3: Except for not performing step S2 of vapor-depositing the molybdenum layer, the rest is the same as Example 2.

[0043] Comparative Example 4: Except that in step S2, H2 is introduced at a rate of 1.1 L / min, MoF6 is 1 g / min, the deposition temperature is 800°C, and the deposition time is 25 min, the rest is the same as Example 2.

[0044] Comparative Example 5: Except that in step S2, H2 is introduced at a rate of 1.1 L / min, MoF6 is 1 g / min, the deposition temperature is 500°C, and the deposition time is 25 min, the rest is the same as Example 2.

[0045] The samples of Example 2 and Comparative Examples 3 to 5 were tested for microhardness, friction and wear properties, and corrosion resistance.

[0046] (1) Microhardness test: The microhardness test is carried out on a HVS-1000 digital microhardness tester; the load is 200g, the loading duration is 20s, and in order to improve the measurement accuracy, 10 indentations are made on each sample, and the average value of the two diagonals of the indentation is taken. (2) Friction and wear test: The friction and wear test is completed on a self-developed multifunctional needle-disc friction and wear tester; the friction ball is a steel ball with a diameter of 4mm, the load is 0.5N (50g), the rotation radius is 60mm, the rotation speed is 50r / min, and the time is 24h. (3) Corrosion performance test: The citric acid solution test method is carried out. The needle is degreased, immersed in a 10% citric acid solution at room temperature for 5h, then taken out, boiled in distilled water for 30min, cooled and kept at room temperature for 48h, then taken out and placed in the air for natural evaporation or blown dry with hot air. The needle surface is visually observed and the changes are recorded. There is no rust phenomenon (grade a). (4) Bending test: The sample acupuncture needle is clamped on the needle clamp (the needle tip is exposed more than 5 mm from the needle clamp), and the needle tip is applied vertically to the steel block at a speed of 10 mm / s to a tensile strength of 4 kg / mm. 2 The force value is maintained for 5s to 10s, and then the load is removed. Then the sample acupuncture needle is observed with a 5x magnifying glass, and there should be no hook on the needle tip.

[0047] Table 1

[0048] Group Hardness / HV Wear Corrosive Bending test results Example 2 645.1±0.3 Still in good shape No rust visible The needle tip has no hook Comparative Example 3 398.4±0.1 After 5 hours, the shape is deformed and worn Corrosion spots appeared after 1 day The needle tip is slightly curved Comparative Example 4 672.8±0.5 11h Slight deformation and wear on the shape Corrosion spots appeared after 2 days Severely bent needle tip Comparative Example 5 422.3±0.2 5h: Deformation and wear of shape Corrosion spots appeared after 1.5 days The needle tip is slightly curved

[0049] Table 1 shows the results of microhardness, friction and wear performance, corrosion resistance and toughness of the samples of Example 2 and Comparative Examples 3 to 5. After the Mo layer is deposited on the surface of the stainless steel, its surface microhardness is higher than that of the substrate. However, when the deposition temperature conditions are changed, the hardness increases. Hardness is very important to ensure the stability and durability of acupuncture needles during use, but the ideal hardness range of acupuncture needles (d = 0.3mm) is approximately between 450HV and 650HV. Too high a hardness will face the problem of reduced toughness. The wear resistance of acupuncture needles can ensure that the acupuncture needles have a long service life and stable performance during use. Example 2 of the present invention has better wear resistance and excellent corrosion resistance than the comparative example. Therefore, the acupuncture needles with a needle-like morphology deposited perpendicular to the surface of the substrate prepared by the present invention have both sufficient hardness to maintain their shape and sufficient toughness to prevent breakage, and the corrosion resistance and wear resistance are enhanced.

[0050] Example 3

[0051] S1. Clean the 316 stainless steel wires with specifications of 0.5mm and 0.6mm, put them into the annealing furnace, introduce N2, and then heat them to 850℃ at a rate of 5℃ / min. Keep them warm for 3 minutes and then cool them naturally. The 0.5mm diameter filaments are used as acupuncture needle blanks, and the other 0.6mm diameter filaments are used as needle handle blanks. The main purpose of annealing stainless steel wire is to improve its mechanical properties, eliminate internal stress, reduce hardness, improve plasticity, and prepare for subsequent processing.

[0052] S2. Place a 10-cm-long acupuncture needle blank and a 10-cm-long needle handle blank into a CVD reaction chamber, Ar is the protective gas, H2 is introduced at a rate of 1.2 L / min, MoF6 is 1.5 g / min, the deposition temperature is 800°C, the deposition time is 20 min, and then the temperature is reduced to 500°C, and the deposition time is 5 min; molybdenum has the advantages of high melting point, good electrical and thermal conductivity, low thermal expansion coefficient, excellent corrosion resistance and high-temperature mechanical properties. The molybdenum layer added to the surface of stainless steel not only makes it have better corrosion resistance and stability in various environments, but also has suitable hardness for manufacturing medical devices. This step adopts the method of controlling the reaction temperature to prepare a molybdenum coating with a needle-like morphology perpendicular to the surface of the substrate, so that the bonding strength of the molybdenum coating and the stainless steel is significantly improved, and the corrosion resistance and wear resistance of the blank surface are significantly enhanced.

[0053] S3, bend the needle handle blank deposited in step S2 into a ring-shaped spiral needle handle, and the needle handle length l1 is 65mm; then cut the deposited acupuncture needle blank in step S2 into a needle body with a length l2 of 55mm and a needle body diameter d of 0.5mm, and cut the needle tip of the cut needle body into a malt-shaped needle tip with a tangent angle α of 45° through a fine grinding process, and the ratio of the needle tip length l3 to the needle body diameter d is 2:1, and the malt-shaped acupuncture needle tip is as follows Figure 2 As shown, malt-type acupuncture needles are Figure 1 As shown in the figure, the needle handle and the other end of the needle tip are melted and connected together using laser welding, and then placed in a centrifuge tube containing a detergent and rotated at 30,000 r / min for 5 minutes to obtain a malt-shaped acupuncture needle with surface impurities removed. The malt-shaped acupuncture needle can penetrate the skin more easily, reduce damage to cells, and thus reduce pain. In addition, the malt-shaped needle helps reduce friction and tissue damage during insertion, thereby greatly alleviating the patient's pain.

[0054] Comparative Example 6: Except for not performing step S2 of vapor-depositing the molybdenum layer, the rest is the same as Example 3.

[0055] Comparative Example 7: Except that in step S2, H2 is introduced at a rate of 1.2 L / min, MoF6 is 1.5 g / min, the deposition temperature is 800°C, and the deposition time is 25 min, the rest is the same as Example 3.

[0056] Comparative Example 8: Except that in step S2, H2 is introduced at a rate of 1.2 L / min, MoF6 is 1.5 g / min, the deposition temperature is 500°C, and the deposition time is 25 min, the rest is the same as Example 3.

[0057] Comparative Example 9: Commercially available ordinary pine needle acupuncture needles, purchased from Gushi Gongyuan Medical Instrument Co., Ltd. Figure 3 As shown, the ratio of the needle tip length l3′ to the needle body diameter d′ of the common pine needle type acupuncture needle is 3:1, and the needle tip of the needle body is cut into a needle tip with a tangent angle β of 30°.

[0058] Evaluating the non-toxicity of acupuncture needles

[0059] The acupuncture needles of Example 3 and Comparative Examples 6 to 9 were placed in a sterile DMEM culture medium, and the acupuncture needles of Example 3 and Comparative Examples 6 to 9 were placed in a sterile DMEM culture medium at an extraction ratio of 0.2 g / mL, incubated at 37°C for 24 hours, and the acupuncture needles were taken out to obtain an extract. The extracts of Example 3 and Comparative Examples 6 to 9 were then diluted to 12.5%, 25%, 50%, and 100% volume fractions, respectively, using DMEM culture medium. L929 fibroblasts (purchased from Guangzhou Yuanjing Biotechnology Co., Ltd.) were cultured and configured to 1×10 5 / ml cell suspension, inoculate it into a 96-well plate, add 100 μL of cell suspension to each well, place the 96-well plate in a cell culture incubator at 37°C and 5% CO2 for 24 hours to allow the cells to adhere to the wall, discard the culture medium, add different volume fractions of the extracts of Example 3 and Comparative Examples 6 to 9, 100 μL per well, add an equal amount of DMEM culture medium as a control, and return the 96-well plate to the cell culture incubator for further culturing for 24 hours. Add 20 μL of MTT reagent (5 mg / mL) and continue culturing for 4 hours. Discard the culture medium, add 100 μL of DMSO, and oscillate for 10 minutes to dissolve the crystals. Use an enzyme marker to read the absorbance value at a wavelength of 490 nm. Calculate the cell survival rate, and calculate the cell survival rates of Example 3 and Comparative Examples 6 to 9 respectively according to the absorbance value. The results are shown in Table 2, and the calculation formula is as follows: Cell survival rate (%) = (absorbance value of the experimental group / absorbance value of the control group) × 100. If the cell survival rate is greater than 75%, it is considered non-toxic.

[0060] Table 2

[0061] Group 12.5％ 25％ 50％ 100％ Example 3 96.2±0.6 94.7±0.1 93.4±0.3 92.5±0.5 Comparative Example 6 86.2±0.5 81.7±0.2 76.2±0.6 72.5±0.2 Comparative Example 7 93.1±0.1 89.2±0.3 85.8±0.2 84.4±0.7 Comparative Example 8 91.7±0.2 86.8±0.3 84.1±0.3 82.7±0.4 Comparative Example 9 87.7±0.4 82.4±0.2 78.2±0.4 77.1±0.1

[0062] Table 2 shows the cytotoxicity test results of the extracts of different volume fractions of acupuncture needles in Example 3 and Comparative Examples 6 to 9. A cell survival rate of more than 90% is ideal, and a cell survival rate between 70% and 90% is generally considered acceptable. The acupuncture needle material in Example 3 of the present invention is non-cytotoxic and suitable for medical use.

[0063] Acupuncture needle pain test

[0064] In order to evaluate the degree of pain caused by acupuncture needles during use, a pain test of acupuncture needles was performed. This test is very important for ensuring the comfort and safety of acupuncture needles in clinical applications. Pain tests usually involve the evaluation of subjective feelings. The pain test method is to purchase 200 20-40 gram male C57BL / 6J mice (purchased from Beijing Beiyou Biotechnology Co., Ltd.), and randomly divide the 200 mice into 5 groups, respectively for Example 3 and Comparative Examples 6-9. Then, insert the acupuncture needles of Example 3 and Comparative Examples 6-9 into the soles of each group of mice for 30 seconds and then pull them out. Record the number of licking and biting the injection site for one hour and whether there is any abnormality in walking. The statistical results are shown in Table 3.

[0065] Table 3

[0066] Group Example 3 Comparative Example 6 Comparative Example 7 Comparative Example 8 Comparative Example 9 At least one of the following abnormalities occurs: licking wounds or abnormal walking 0 37 32 34 28 No licking or biting wounds and walking normally 40 3 8 6 12

[0067] Table 3 shows the results of acupuncture pain tests on mice in Example 3 of the present invention and Comparative Examples 6 to 9. After acupuncture was performed on mice using Example 3 of the present invention, the mice did not show licking, biting, or abnormal walking, while the mice in Comparative Examples 6 to 9 showed licking, biting, and abnormal walking. The above illustrates that the molybdenum coating with a needle-like morphology perpendicular to the surface of the substrate prepared by vapor deposition greatly reduces the pain of acupuncture needles piercing the skin, which may be related to the high hardness of the acupuncture needles. Less force is required during puncture, which can reduce stimulation to nerve endings and thus reduce pain. In addition, the tangent angle of the malt-type acupuncture needle is greater than that of the ordinary needle type. This needle can penetrate the skin more easily, reduce damage to cells, and thus reduce pain. And the malt-type needle helps to reduce friction and tissue damage during insertion, thereby greatly reducing the patient's pain.

[0068] The embodiments described above are merely descriptions of the preparation process of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solution of the present invention by ordinary technicians in this field should all fall within the protection scope determined by the claims of the present invention.

Claims

1. A method for preparing a malt-type acupuncture needle based on a new material, characterized in that: The specific preparation steps are as follows: S1. Clean 316 stainless steel wires with specifications of 0.1-0.5 mm and 0.2-0.6 mm, put the cleaned 316 stainless steel wires into an annealing furnace, introduce N2, and then heat to 850°C at a rate of 5°C / min, keep warm for 1-3 minutes and then cool naturally. The filaments with a diameter of 0.1-0.5 mm are used as acupuncture needle blanks, and the other filaments with a diameter of 0.2-0.6 mm are used as needle handle blanks; S2. Place a 10 cm long acupuncture needle blank and a 10 cm long needle handle blank into a CVD reaction chamber. Ar is the protective gas. H2 is introduced at a rate of 1.0-1.2 L / min. MoF6 is 0.8-1.5 g / min. The deposition temperature is 800°C for 20 min, then lowered to 500°C for 5 min. S3, bending the needle handle blank after deposition in step S2 into an annular spiral needle handle (1), wherein the needle handle length l1 is 35 to 65 mm; then cutting the deposited acupuncture needle blank in step S2 into a needle body (2) with a length l2 of 30 to 55 mm, and a needle body diameter d of 0.10 to 0.5 mm, and cutting the needle tip (3) of the cut needle body (2) into a malt-shaped needle tip with a tangent angle α of 45° to 50°, wherein the ratio of the needle tip length l3 of the needle tip to the needle body diameter d is 2:1; using laser welding to melt and connect the needle handle and the other end of the needle body tip together, and then placing them in a centrifuge tube containing a detergent, and rotating them at a speed of 10,000 to 30,000 r / min for 4 to 5 minutes to obtain a malt-shaped acupuncture needle with surface impurities removed.

2. The method for preparing a malt-type acupuncture needle based on a new material according to claim 1, characterized in that: In the step S1, 316 stainless steel wires with specifications of 0.1 mm and 0.2 mm are cleaned.

3. The method for preparing a malt-type acupuncture needle based on a new material according to claim 2, characterized in that: In step S1, the mixture is kept warm for 1 minute and then cooled naturally.

4. The method for preparing a malt-type acupuncture needle based on a new material according to claim 3, characterized in that: In the step S2, the amount of MoF6 is 0.8 g / min.

5. The method for preparing a malt-type acupuncture needle based on a new material according to claim 4, characterized in that: In the step S2, H2 is introduced at a speed of 1.0 L / min.

6. The method for preparing a malt-type acupuncture needle based on a new material according to claim 5, characterized in that: The length of the needle handle in step S3 is 35 mm.

7. The method for preparing a malt-type acupuncture needle based on a new material according to claim 6, characterized in that: In the step S3, the needle tip (3) of the needle body (2) is cut into a malt-shaped needle tip with a tangent angle α of 45°.

8. The method for preparing a malt-type acupuncture needle based on a new material according to claim 7, characterized in that: In step S3, the needle is rotated at a speed of 10000 r / min for 4 min to obtain the malt-shaped acupuncture needle with surface impurities removed.

9. The method for preparing a malt-type acupuncture needle based on a new material as described in any one of claims 1 to 8 produces a malt-type acupuncture needle.

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