Insulating acupuncture needle with coating and manufacturing method thereof
By forming a nano-scale paraxylene polymer coating and an anti-mildew and antibacterial layer on the surface of acupuncture needles, the problems of poor insulation and anti-mildew and antibacterial properties caused by traditional coating methods are solved, and the precise current conduction and safety of acupuncture needles are achieved.
Patent Information
- Application Number
- CN202510902734.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-01
- Publication Date
- 2025-10-17
AI Technical Summary
Traditional coating methods make it difficult to achieve uniform and continuous coating coverage on acupuncture needles, resulting in poor insulation and mildew and antibacterial properties, affecting the accuracy and safety of current conduction.
Chemical vapor deposition is used to form a nano-scale paraxylene polymer coating on the surface of acupuncture needles, combined with anti-mildew and antibacterial layers such as hyaluronic acid to form a molecular-level bonding interface to ensure the thickness and continuity of the coating.
The insulation, mildew-proof and antibacterial properties of acupuncture needles are improved, ensuring the accuracy and safety of current conduction, reducing the risk of infection, and improving treatment comfort and efficiency.
Smart Images
Figure CN120788902A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of medical acupuncture needles, more particularly to an insulated acupuncture needle with a coating and a manufacturing method thereof. BACKGROUND
[0002] In medical practice, the safety and hygiene of acupuncture needles as a common treatment tool are crucial to the health of patients, and in acupuncture treatment, a certain current is often applied to stimulate the acupoint tissue, but since the meridians and acupoints are at a certain depth in the human body, the acupuncture needle needs to penetrate the skin, and the current cannot accurately reach the designated acupoint along the epidermis and dermis, and the outer surface of the acupuncture needle directly contacts blood and body fluids, which can easily become a place for microorganisms to attach and multiply, in order to improve the accuracy of current conduction stimulation and reduce the risk of infection, a coating with antifungal, antibacterial, and anticorrosive and insulating properties needs to be selected to coat the acupuncture needle.
[0003] Traditional coating methods such as spraying, brushing, or sedimentation are difficult to achieve uniform and continuous coating coverage when applied to small acupuncture needles due to a lack of sufficient weight, resulting in uneven distribution of the coating on the surface of the acupuncture needle and the inability to form a complete insulating layer, the control accuracy of the thickness of the traditional coating method is not high, and an excessively thick coating may affect the elasticity and puncture performance of the acupuncture needle, while an excessively thin coating may not provide sufficient insulating effect, and traditional coatings are also prone to air gaps, which are formed due to shrinkage of the coating material during solidification or insufficient adhesion between the coating and the surface of the acupuncture needle, these air gaps can destroy the continuity of the coating and further reduce the insulating performance, therefore a new solution is needed to solve the problem of traditional acupuncture needles that cannot accurately reach the designated acupoint when conducting current and poor antifungal and antibacterial performance. SUMMARY
[0004] In view of the deficiencies of the prior art, the purpose of the present application is to provide an insulated acupuncture needle with a coating and a manufacturing method thereof, by improving the insulating property of the coating, to achieve the purpose of providing the accuracy of acupuncture needle stimulation of acupoints and the antifungal and antibacterial properties of acupuncture needles.
[0005] The above technical purpose of the present application is achieved by the following technical solution: an insulated acupuncture needle with a coating, comprising a handle, a needle body, and a needle tip, the outer surface of the needle body is fixedly connected with a p-xylene polymer coating.
[0006] The present application is further provided as: the p-xylene polymer coating is a nano coating, the p-xylene polymer coating is one of p-toluene dimer, dichloro-p-toluene dimer, or octafluoro-p-toluene dimer.
[0007] The present application is further provided as: the thickness of the p-xylene polymer coating is 3-4 microns.
[0008] The application is further configured to form a p-xylene polymer coating on the needle body by chemical vapor deposition.
[0009] The application is further configured to have a dielectric strength of the p-xylene polymer coating greater than 5300 (V / mil).
[0010] The application is further configured to form a molecular level bonding interface between the biocompatible layer and the p-xylene polymer coating, so that the peeling strength of the composite coating reaches 5.6-6.8 N / mm, and in the biocompatible layer, the deposition layer ratio of hyaluronic acid to sulfonic acid group is 1:1.2-1.5, and the total number of deposition layers is 8-12 layers.
[0011] The application is further configured to have a deposition temperature of the p-xylene polymer coating of 35±1℃.
[0012] The application is further configured to have a deposition time of the p-xylene polymer coating of 6-8 hours.
[0013] The application is further configured to have a deposition temperature of the p-xylene polymer coating of 35±1℃.
[0014] The application is further configured to have a deposition time of the p-xylene polymer coating of 6-8 hours.
[0015] Step one, shield the needle handle, needle tip and positions not requiring coating on the needle body, place the acupuncture needle on the substrate in the vacuum deposition chamber so that the needle body is exposed to the p-xylene polymer coating.
[0016] Step two, add solid p-xylene raw material to the evaporation cavity, heat and gasify to obtain dimer gas;
[0017] Step three, the sublimed dimer gas enters the cracking cavity, and is heated to 680℃ to form p-xylene polymer monomers by high temperature cracking;
[0018] Step four, in the vacuum deposition chamber, the p-xylene polymer monomers are polymerized and deposited on the surface of the needle body to form an acupuncture needle with a p-xylene polymer coating.
[0019] In summary, the application has the following beneficial effects:
[0020] The p-xylene polymer coating is uniformly coated on the surface of the needle body of the acupuncture needle, completely isomorphic, dense and without pinholes, smooth surface, no foreign matter, the coating does not fall off, transparent and stress-free, does not contain additives, does not damage the acupuncture needle, has excellent electrical insulation and protection, so that the coated acupuncture needle has more effective antibacterial, mildew and corrosion resistance.
[0021] The unique vacuum vapor deposition process is adopted to prepare the p-xylene polymer coating layer which is grown on the surface of acupuncture needle by active small molecules, so as to meet the application environment of fumigation high temperature, ethylene oxide and other disinfection.
[0022] The anti-mildew and antibacterial layer coated on the outer surface of the p-xylene polymer coating layer has good biocompatibility and anti-mildew and antibacterial performance, and the multi-layer structure combined with the p-xylene polymer coating layer can not only provide better insulation effect, but also enhance the strength and durability of the needle body. BRIEF DESCRIPTION OF DRAWINGS
[0023] Figure 1 The figure is a structural schematic diagram of the present application;
[0024] Figure 2 The figure is a sectional view of the vacuum coating equipment.
[0025] In the figure: 1, handle; 2, needle body; 3, needle tip; 4, evaporation cavity; 5, cracking cavity; 6, vacuum deposition chamber. DETAILED DESCRIPTION
[0026] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application; obviously, the described embodiments are only part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.
[0027] Embodiment:
[0028] The present application will be described in detail below with reference to the drawings and embodiments.
[0029] As Figure 1As shown, an insulated acupuncture needle with a coating, the acupuncture needle is made of austenitic stainless steel, including a handle 1, a needle body 2 and a needle tip 3, the outer surface of the needle body 2 is coated with a transparent p-xylene polymer coating by chemical vapor deposition, the p-xylene polymer coating is a nano coating, the p-xylene polymer coating is set as one of p-toluene dimer, dichloro-p-toluene dimer or octafluoro-p-toluene dimer, the outer surface of the p-xylene polymer coating is coated with a mildew-resistant antibacterial layer, the mildew-resistant antibacterial layer includes hyaluronic acid, alginic acid, natural polysaccharides containing sulfonic acid groups or carboxylic acid groups or their derivatives, the hyaluronic acid can enhance the local release of antibiotics by combining with antibiotics, thereby having antibacterial properties, the alginic acid has good biodegradability and biocompatibility, and has significant antibacterial performance, the sulfonated chitosan introduces sulfonic groups to increase its solubility and antibacterial performance, the needle body coated with the mildew-resistant antibacterial layer has good biocompatibility, which has been demonstrated by the US FDA and meets the US Pharmacopoeia Class VI standard for biomedical materials, an external current is applied to the end of the acupuncture needle close to the handle 1, and the acupuncture point is electrically stimulated through the needle tip 3 or the position of the needle body 2 where the p-xylene polymer coating is not coated.
[0030] As Figure 1 shown, the dielectric strength of the p-xylene polymer coating is greater than 5300 (V / mil), the p-xylene polymer coating with high dielectric strength can more effectively prevent current leakage, ensure the good insulation of the acupuncture needle, guarantee the safety and effectiveness in the powered state, reduce the unnecessary current stimulation felt by the patient during acupuncture treatment, improve the comfort of treatment, also can prevent the damage to the surrounding tissues when the current passes through the needle body 2, reduce the risk of infection and inflammation, the good insulation performance of the p-xylene polymer coating can reduce the loss of energy, making the acupuncture treatment more efficient, the p-xylene polymer coating can also efficiently block body fluids, moisture and chemicals, thereby preventing the growth and reproduction of microorganisms on the outer surface of the needle body 2, human cells are easy to grow on the surface of the p-xylene polymer coating, forming a thin layer of tissue with the same structure, which helps wound healing and reduces the risk of infection, the p-xylene polymer coating has good self-lubricating effect, which helps smooth operation of the acupuncture needle and reduces damage to the tissue, the p-xylene polymer coating can meet the application environment of fumigation high temperature, ethylene oxide and other disinfection.
[0031] As Figure 1As shown, the dielectric strength of the xylene polymer coating is greater than 5300 (V / mil). The xylene polymer coating with high dielectric strength can more effectively prevent the leakage of current, ensure that the acupuncture needle has good insulation, ensure safety and effectiveness when powered, reduce unnecessary current stimulation felt by patients during acupuncture treatment, improve the comfort of treatment, and prevent damage to surrounding tissues when current passes through the needle body 2, reducing the risk of infection and inflammation. The good insulation performance of the xylene polymer coating can reduce energy loss and make acupuncture treatment more efficient. The xylene polymer coating can also effectively block body fluids, moisture and chemicals, thereby preventing microorganisms from growing and multiplying on the outer surface of the needle body 2. Human cells can easily grow on the surface of the xylene polymer coating to form a thin layer of tissue with the same structure, which helps wound healing and reduces the risk of infection. The xylene polymer coating has a good self-lubricating effect, which helps the smooth operation of the acupuncture needle and reduces damage to tissues. The xylene polymer coating can meet the application environments of various disinfections such as fumigation high temperature and ethylene oxide.
[0032] like Figure 2 As shown, the coating equipment of the xylene polymer coating includes a vacuum coating equipment. The cavity size of the vacuum coating equipment is Φ960xL650. The vacuum coating equipment is provided with an evaporation chamber 4, a cracking chamber 5 and a vacuum deposition chamber 6. The vacuum deposition chamber 6 is connected to a -70°C cold trap. The cold trap and the vacuum pump are integrated into one and can be moved as a whole with the vacuum coating equipment. The vacuum coating equipment adopts a rolling cavity, which has a fast deposition speed, a short film forming time, good coating uniformity, and improves production efficiency. It is also equipped with two control systems: physical button control and PLC control to maximize product safety.
[0033] The method for coating acupuncture needles with a paraxylene polymer coating is as follows:
[0034] Step 1: Mask the areas of the needle shaft 1, needle tip 3, and needle body 2 that do not need to be coated to protect these areas from the effects of the coating. Place the acupuncture needles on a substrate in a vacuum deposition chamber 6 for subsequent coating operations.
[0035] Step 2: adding solid paraxylene raw material into the evaporation chamber 4, heating and vaporizing it to obtain dimer gas;
[0036] Step 3: The sublimated dimer gas enters the cracking chamber 5, where it is heated to 680°C and cracked to form p-xylene polymer monomers;
[0037] Step 4: In the vacuum deposition chamber 6, the p-xylene polymer monomer is polymerized and deposited on the surface of the needle body 2 at a deposition temperature of 35±1° C. for 6-8 hours, and finally a p-xylene polymer coating with a thickness of 3-4 μm is formed on the surface of the acupuncture needle.
[0038] As Figure 2 shown, using vacuum coating equipment can precisely control the thickness of the p-xylene polymer coating layer, without affecting the appearance and performance of the acupuncture needle, and also can protect the patient's body from the release of harmful substances contained in the acupuncture needle.
[0039] The preparation method of the mildew-resistant and antibacterial layer comprises: dissolving the positively or negatively charged mildew-resistant and antibacterial layer raw material in water or a mixture of water and an organic solvent, the weight concentration of the mildew-resistant and antibacterial layer raw material is 1%-10%, the pH value of the dissolved solution is 1-11, the solution is deposited on the surface of the needle body coated with the p-xylene polymer coating layer by a gas phase deposition polymerization method, and the positively and negatively charged mildew-resistant and antibacterial layer raw materials are alternately performed.
[0040] Insulation performance test
[0041] The tin foil paper is fixed in the block-shaped soft silicone rubber, one end of the tin foil paper is located outside the soft silicone rubber, the resistance, the small bulb, the switch, the power supply and the one end of the tin foil paper located outside the soft silicone rubber are connected by wires in turn, the other end of the resistance is connected with one end of the two ends of the bare control wire by wires, the control wire is inserted into the soft silicone rubber block, and it is observed that the small bulb is bright when the bare part of one end of the wire contacts the aluminum foil, the small bulb is not bright when the part of the wire wrapped with the insulating outer skin contacts the aluminum foil, and the power supply switch is turned off.
[0042] The acupuncture needles without coating, the acupuncture needles with the coating layer with a thickness of 1.5 μm and 4 μm are used to replace the control wire inserted into the soft silicone rubber block in turn, and the test results are shown in Table 1:
[0043]
[0044] As shown in Table 1, the acupuncture needle coated with the p-xylene polymer coating layer with a thickness of 4 μm has good selective insulation, can reduce the interference of the current, makes the conduction of the acupuncture needle more concentrated and accurate, prevents the current from passing through the non-treatment site, thereby reducing the possible electric shock injury and protecting the safety of the patient.
[0045] As Figure 1-Figure 2 shown, the acupuncture needle coated with the p-xylene polymer coating layer has good corrosion resistance, organic solvent resistance, antibacterial and antioxidant, low resistance, low friction coefficient and biocompatibility, effectively realizes the antibacterial and mildew-proof effect, and helps to improve the quality and safety of the acupuncture needle.
[0046] The above only describes the preferred embodiments of the present application, and the protection scope of the present application is not limited to the above-mentioned embodiments, and any technical solutions falling within the concept of the present application shall fall within the protection scope of the present application. It should be noted that for ordinary skilled persons in the art, some improvements and decorations without departing from the principles of the present application shall also be considered as the protection scope of the present application.
Claims
1. An insulated acupuncture needle with a coating, comprising a needle handle (1), a needle body (2) and a needle tip (3), characterized in that: The outer surface of the needle body (2) is fixedly connected to a p-xylene polymer coating, and the outer surface of the p-xylene polymer coating is fixedly connected to a biocompatible layer, and the biocompatible layer includes hyaluronic acid, alginic acid, a natural polysaccharide containing a sulfonic acid group or a carboxylic acid group, or a derivative thereof; The method for preparing the biocompatible layer includes: dissolving the biocompatible layer raw material with a positive or negative charge in water or a mixture of water and an organic solvent, wherein the weight concentration of the biocompatible layer raw material is 1% to 10%, and the pH value of the dissolved solution is 1-11; and depositing the solution on the surface of a needle coated with a paraxylene polymer coating by vapor deposition polymerization, with the positively and negatively charged biocompatible layer raw materials being deposited alternately.
2. The coated insulated acupuncture needle according to claim 1, characterized in that: The p-xylene polymer coating is a nano coating, and the p-xylene polymer coating is configured as one of p-toluene dimer, dichloro p-toluene dimer, and octafluoro p-toluene dimer.
3. The coated insulated acupuncture needle according to claim 2, characterized in that: The thickness of the p-xylene polymer coating is 3-4 μm.
4. The coated insulated acupuncture needle according to claim 3, characterized in that: The dielectric strength of the paraxylene polymer coating is greater than 5300 (V / mil).
5. The coated insulated acupuncture needle according to claim 1, characterized in that: A molecular-level bonding interface is formed between the biocompatible layer and the paraxylene polymer coating, so that the peel strength of the composite coating reaches 5.6-6.8N / mm. In the biocompatible layer, the deposition layer ratio of hyaluronic acid to sulfonic acid group is 1:1.2-1.5, and the total number of deposition layers is 8-12 layers.
6. The method for preparing a coated insulated acupuncture needle according to any one of claims 1 to 5, characterized in that: A p-xylene polymer coating is formed on the needle body (2) by chemical vapor deposition.
7. The method for preparing a coated insulated acupuncture needle according to claim 6, characterized in that: The deposition temperature of the p-xylene polymer coating is 35±1°C.
8. The method for manufacturing a coated insulated acupuncture needle according to claim 7, characterized in that: The deposition time of the p-xylene polymer coating is 6-8 hours.
9. The method for manufacturing a coated insulated acupuncture needle according to claim 8, characterized in that: The coating equipment for the p-xylene polymer coating comprises a vacuum coating equipment, wherein the vacuum coating equipment is provided with an evaporation chamber (4), a cracking chamber (5) and a vacuum deposition chamber (6).
10. The method for manufacturing a coated insulated acupuncture needle according to claim 9, characterized in that: The method for coating the acupuncture needle with a p-xylene polymer coating is as follows: Step 1: Mask the needle handle (1), the needle tip (3), and the parts of the needle body (2) that do not need to be coated, and place the acupuncture needle on a substrate in a vacuum deposition chamber (6); Step 2: adding solid paraxylene raw material into the evaporation chamber (4), heating and vaporizing it to obtain dimer gas; Step 3: The sublimated dimer gas enters the cracking chamber (5), is heated to 680°C, and is cracked at high temperature to form p-xylene polymer monomer; Step 4: In the vacuum deposition chamber (6), the p-xylene polymer monomer is polymerized and deposited on the surface of the needle body (2), and finally an acupuncture needle with a p-xylene polymer coating is formed.