CN115337203A - Acupuncture needle with insulating coating and preparation method thereof - Google Patents
Acupuncture needle with insulating coating and preparation method thereof Download PDFInfo
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- CN115337203A CN115337203A CN202211166366.7A CN202211166366A CN115337203A CN 115337203 A CN115337203 A CN 115337203A CN 202211166366 A CN202211166366 A CN 202211166366A CN 115337203 A CN115337203 A CN 115337203A
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Abstract
Description
技术领域technical field
本发明涉及医疗器械技术领域,具体为一种具有绝缘涂层的针灸针及制备方法。The invention relates to the technical field of medical devices, in particular to an acupuncture needle with an insulating coating and a preparation method thereof.
背景技术Background technique
针灸是一种把针具按照一定的角度刺入患者体内,运用针刺手法来对人体特定部位进行刺激从而达到治疗疾病效果的中医疗法,而在针灸治疗中所使用到的针具,一般将其称为针灸针,针灸针通常由金属材质所制成,整体细长,其中一端设置有针尖,可以由医师控制,刺入人体皮下穴位,达到治疗的目的。Acupuncture is a traditional Chinese medicine therapy in which needles are inserted into the patient's body at a certain angle, and acupuncture techniques are used to stimulate specific parts of the human body to achieve the effect of treating diseases. The needles used in acupuncture treatment are generally They are called acupuncture needles. Acupuncture needles are usually made of metal materials and are slender overall. One end is provided with a needle point, which can be controlled by a doctor to penetrate into the subcutaneous points of the human body to achieve the purpose of treatment.
现有的针灸针及制备方法通常采用将原材料进行拉伸打磨的方式进行成型,因此导致现有的针灸针加工完成后表面金属的氧化膜被破坏,针灸针表面不绝缘,针灸效果和使用不便,同时,氧化膜破坏后,针灸针表面易生锈,影响使用寿命,现有的针灸针使用时需要蘸药液进行使用,药液对针灸针表面的附着效果差,导致针灸针的有效性和实用性较差。Existing acupuncture needles and their preparation methods are usually shaped by stretching and grinding the raw materials, which leads to the destruction of the metal oxide film on the surface of the existing acupuncture needles after processing, the surface of the acupuncture needles is not insulated, and the acupuncture effect and use are inconvenient. At the same time, after the oxidation film is destroyed, the surface of acupuncture needles is prone to rust, which affects the service life. The existing acupuncture needles need to be dipped in medicinal liquid for use, and the adhesion of medicinal liquid to the surface of acupuncture needles is poor, resulting in the effectiveness of acupuncture needles. and less practical.
发明内容Contents of the invention
(一)解决的技术问题(1) Solved technical problems
针对现有技术的不足,本发明提供了一种具有绝缘涂层的针灸针及制备方法,解决了现有的针灸针及制备方法制出的针灸针绝缘性差,药物效果释放不稳定,使用时的便捷性和安全性差,整体的有效性和实用性不强的问题。Aiming at the deficiencies of the prior art, the present invention provides an acupuncture needle with an insulating coating and a preparation method, which solves the problem of poor insulation of the acupuncture needles produced by the existing acupuncture needles and the preparation method, unstable release of drug effects, and difficulty in using them. The convenience and safety of the system are poor, and the overall effectiveness and practicability are not strong.
(二)技术方案(2) Technical solutions
为实现以上目的,本发明通过以下技术方案予以实现:一种具有绝缘涂层的针灸针,包括持握机构,所述持握机构内部中心处嵌入固定设置有针体机构,所述持握机构包括握柄,所述握柄上端固定连接有螺纹杆,所述针体机构包括不锈钢针体,所述不锈钢针体外表面固定设置有绝缘层,所述绝缘层固定设置有药膜。In order to achieve the above purpose, the present invention is achieved through the following technical solutions: an acupuncture needle with an insulating coating, including a holding mechanism, a needle body mechanism is embedded and fixed at the center of the holding mechanism, and the holding mechanism It includes a handle, the upper end of the handle is fixedly connected with a threaded rod, the needle body mechanism includes a stainless steel needle body, an insulating layer is fixedly arranged on the outer surface of the stainless steel needle, and a drug film is fixedly arranged on the insulating layer.
一种具有绝缘涂层的针灸针制备方法,具体包括以下步骤:A method for preparing acupuncture needles with an insulating coating, specifically comprising the following steps:
S1.针体制备S1. Needle preparation
取适当长度的不锈钢金属管,将其进行拔丝处理,使不锈钢管形成0.25-0.35mm的丝状物,截取9-12cm长度的丝状物,将丝状物一端通过电化学法腐蚀加工成针状,制得所述不锈钢针体;Take a stainless steel metal tube of appropriate length, and wire-draw it to make the stainless steel tube form a filament of 0.25-0.35mm, cut off a filament of 9-12cm in length, and corrode one end of the filament into a needle by electrochemical method. shape, the stainless steel needle body is obtained;
S2.针体清洁S2. Needle cleaning
将制得的所述不锈钢针体依次通过丙酮溶液、盐酸溶液和氢氧化钠溶液,之后放入到装有RO水的超声波清洗机中进行清洗,清洗结束后晾干备用;Pass the prepared stainless steel needle body through acetone solution, hydrochloric acid solution and sodium hydroxide solution in turn, then put it into an ultrasonic cleaning machine equipped with RO water for cleaning, and dry it for later use after cleaning;
S3.针体涂膜S3. Needle body coating
将所述不锈钢针体固定到涂膜模具内,配制涂膜材料的溶胶先驱体,通过注射器将溶胶先驱体注入到模具内,反复循环多次直至所述不锈钢针体表面涂层均匀,并将针尖部位涂层去除;Fix the stainless steel needle body in the coating mold, prepare the sol precursor of the coating material, inject the sol precursor into the mold through a syringe, repeat the cycle several times until the surface coating of the stainless steel needle body is even, and put Coating removal at the tip of the needle;
S4.绝缘层烧制S4. Insulation layer firing
将表面带有涂层的所述不锈钢针体放入马弗炉中进行烧制,使所述不锈钢针体表面形成绝缘层;Putting the stainless steel needle body with coating on the surface into a muffle furnace for firing, so that the surface of the stainless steel needle body forms an insulating layer;
S5.握柄安装S5. Grip installation
将握柄及螺纹管的模具固定安装到所述不锈钢针体上端3cm处,将ABS树脂加热至熔融,倒入模具中,将整体放入冷却箱中进行冷却,冷却至室温后脱模;Fix the handle and the mold of the threaded pipe to the upper 3cm of the stainless steel needle body, heat the ABS resin to melt, pour it into the mold, put the whole in a cooling box for cooling, and demould after cooling to room temperature;
S6.药膜制备S6. Drug film preparation
取丹参及藏红花适量,加入5倍量的体积分数80-95%乙醇回流提取5次,每次3小时,合并提取液,浓缩,干燥,得到丹参及藏红花提取物;Take an appropriate amount of Salvia miltiorrhiza and saffron, add 5 times the amount of ethanol with a volume fraction of 80-95% to reflux for extraction 5 times, each time for 3 hours, combine the extracts, concentrate, and dry to obtain the extracts of Salvia miltiorrhiza and saffron;
S7.药膜喷涂S7. Membrane spraying
取丹参及藏红花提取物2-3倍量的体积分数3%的PLGA溶液,将提取物和PLGA溶液进行混合,搅拌溶解,采用喷雾法将混合后的溶液均匀喷涂于不锈钢针体的表面,喷涂完成后,放置于真空干燥箱中干燥15-20小时,即得到该针灸针。Take the 3% PLGA solution with a volume fraction of 2-3 times the amount of salvia miltiorrhiza and saffron extract, mix the extract and PLGA solution, stir and dissolve, and spray the mixed solution evenly on the surface of the stainless steel needle body by spraying, spray After completion, it is placed in a vacuum drying oven to dry for 15-20 hours to obtain the acupuncture needle.
优选的,所述S1中,电化学法所用的腐蚀液为氯化钠溶液,腐蚀电压为15V,腐蚀时间为8min。Preferably, in said S1, the corrosion solution used in the electrochemical method is sodium chloride solution, the corrosion voltage is 15V, and the corrosion time is 8 minutes.
优选的,所述S2中超声波清洗机的清洗频率为28-40KHz,功率为480-650W,清洗时间为15-20min。Preferably, the cleaning frequency of the ultrasonic cleaning machine in S2 is 28-40KHz, the power is 480-650W, and the cleaning time is 15-20min.
优选的,所述S3中,涂膜材料的溶胶先驱体为二氧化钛溶胶先驱体或二氧化硅溶胶先驱体,所述绝缘层为二氧化钛涂层或二氧化硅涂层。Preferably, in S3, the sol precursor of the coating material is a titania sol precursor or a silica sol precursor, and the insulating layer is a titania coating or a silica coating.
优选的,所述S4中,马弗炉的烧结温度为800-1000℃,烧结时间为60-80min。Preferably, in S4, the sintering temperature of the muffle furnace is 800-1000° C., and the sintering time is 60-80 min.
优选的,所述S5中,ABS树脂的熔融温度为250-280℃。Preferably, in S5, the melting temperature of the ABS resin is 250-280°C.
优选的,所述S6中,PLGA溶液乙交酯、丙交酯和氯仿的质量比为1:1.5:100,喷射速率为0.6-1m/s,喷药时间为25min。Preferably, in the S6, the mass ratio of glycolide, lactide and chloroform in the PLGA solution is 1:1.5:100, the spray rate is 0.6-1m/s, and the spraying time is 25 minutes.
(三)有益效果(3) Beneficial effects
本发明提供了一种具有绝缘涂层的针灸针及制备方法。具备以下有益效果:The invention provides an acupuncture needle with insulating coating and a preparation method. Has the following beneficial effects:
1、本发明提供了一种具有绝缘涂层的针灸针及制备方法,相较于现有的针灸针及制备方法,该针灸针及制备方法通过在针灸针的表面设置有绝缘层,绝缘层采用二氧化钛涂层或二氧化硅涂层,二者均对不锈钢材质有良好的附着效果,并且对人体皮肤和组织无刺激,化学性质稳定,绝缘性能良好,还可以防止针体生锈,提升针灸针的使用寿命,同时,该针灸针在作为电针使用时,绝缘层的设置可以让外界输入的电流从未设置绝缘层的针柄处直达未设置绝缘层的针尖处进入人体,减少电流的中途损耗,使电流可以直接刺激穴位或患部深处,增强该针灸针的针灸效果。1. The present invention provides an acupuncture needle with an insulating coating and its preparation method. Compared with the existing acupuncture needles and its preparation method, the acupuncture needle and its preparation method are provided with an insulating layer on the surface of the acupuncture needle, and the insulating layer It adopts titanium dioxide coating or silicon dioxide coating, both of which have a good adhesion effect on stainless steel, and are non-irritating to human skin and tissues. They have stable chemical properties and good insulation performance. They can also prevent the needle body from rusting and improve acupuncture and moxibustion. At the same time, when the acupuncture needle is used as an electric needle, the setting of the insulating layer can allow the current input from the outside to enter the human body from the needle handle without the insulating layer to the needle tip without the insulating layer, reducing the loss of current Loss in the middle, so that the current can directly stimulate the acupuncture point or the deep part of the affected part, and enhance the acupuncture effect of the acupuncture needle.
2、本发明提供了一种具有绝缘涂层的针灸针及制备方法,相较于现有的针灸针及制备方法,该针灸针及制备方法通过在针体表面喷涂有由藏红花和丹参提取物所制成的药膜,藏红花和丹参都有活血化瘀的功效,通过PLGA作为二者有效成分的载体,结合以喷雾法在针灸针表面形成含活血化瘀有效成分的膜层,可以使中药中的活性成分和针体表面的药膜进行稳定结合,针灸针刺入人体后,二者的有效成分可以在人体内快速释放,并增加有效成分的透入量,提升该针灸针及制备方法的有效性和实用性。2. The present invention provides an acupuncture needle with an insulating coating and its preparation method. Compared with the existing acupuncture needle and its preparation method, the acupuncture needle and its preparation method are sprayed with the extracts of saffron and salvia miltiorrhiza on the surface of the needle body. The prepared medicinal film, saffron and salvia miltiorrhiza have the effect of promoting blood circulation and removing blood stasis. PLGA is used as the carrier of the active ingredients of the two, combined with the spray method to form a film layer containing the active ingredients of promoting blood circulation and removing blood stasis on the surface of acupuncture needles, which can make the traditional Chinese medicine The active ingredients in the needle are stably combined with the drug film on the surface of the needle body. After the acupuncture needle penetrates into the human body, the active ingredients of the two can be released quickly in the human body, and the penetration of the active ingredient can be increased, which improves the acupuncture needle and its preparation method. effectiveness and practicality.
3、本发明提供了一种具有绝缘涂层的针灸针及制备方法,相较于现有的针灸针及制备方法,该针灸针及制备方法通过在其尾端设置有由ABS树脂材料所制成的握柄和螺纹杆,在便于使用者进行持握和将该针灸针连接到其他装置进行使用的同时,ABS树脂材料同时具有较好的抗菌性能和较高的硬度,有利于满足医师在日常进行针灸治疗中的使用需求,进一步提升其在实际使用中的便捷性和安全性。3. The present invention provides an acupuncture needle with an insulating coating and its preparation method. Compared with the existing acupuncture needle and its preparation method, the acupuncture needle and its preparation method are provided with an ABS resin material at its tail end. The handle and threaded rod are convenient for the user to hold and connect the acupuncture needle to other devices for use. The ABS resin material also has good antibacterial properties and high hardness, which is conducive to satisfying the needs of doctors in the medical field. The daily use of acupuncture and moxibustion treatment needs to further enhance its convenience and safety in actual use.
附图说明Description of drawings
图1为本发明的轴测示意图;Fig. 1 is axonometric schematic diagram of the present invention;
图2为本发明的正剖视示意图;Fig. 2 is the front sectional schematic diagram of the present invention;
图3为本发明的俯剖视示意图。Fig. 3 is a schematic top sectional view of the present invention.
其中,1、持握机构;2、针体机构;101、螺纹杆;102、握柄;201、药膜;202、绝缘层;203、不锈钢针体。Wherein, 1. holding mechanism; 2. needle body mechanism; 101, threaded rod; 102, handle; 201, drug film; 202, insulating layer; 203, stainless steel needle body.
具体实施方式Detailed ways
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.
实施例:Example:
如图1-3所示,本发明实施例提供一种具有绝缘涂层的针灸针,包括持握机构1,持握机构1内部中心处嵌入固定设置有针体机构2,持握机构1包括握柄102,有利于使用者对该针灸针进行持握使用,握柄102上端固定连接有螺纹杆101,便于使用者将该针灸针连接到其他设备进行使用,针体机构2包括不锈钢针体203,不锈钢针体203外表面固定设置有绝缘层202,有利于提升该针灸针整体的绝缘性和使用寿命,绝缘层202固定设置有药膜201,有利于增强该针灸针在人体内药物成分的释放效率,提升该针灸针的治疗效果。As shown in Figures 1-3, the embodiment of the present invention provides an acupuncture needle with an insulating coating, including a
一种具有绝缘涂层的针灸针制备方法,具体包括以下步骤:A method for preparing acupuncture needles with an insulating coating, specifically comprising the following steps:
S1.针体制备S1. Needle preparation
取适当长度的不锈钢金属管,将其进行拔丝处理,使不锈钢管形成0.25-0.35mm的丝状物,截取9-12cm长度的丝状物,将丝状物一端通过电化学法腐蚀加工成针状,制得不锈钢针体203,有利于确保该针灸针原材料的强度,降低对其加工成型的难度,提升该方法的加工效率;Take a stainless steel metal tube of appropriate length, and wire-draw it to make the stainless steel tube form a filament of 0.25-0.35mm, cut off a filament of 9-12cm in length, and corrode one end of the filament into a needle by electrochemical method. shape, and the stainless
S2.针体清洁S2. Needle cleaning
将制得的不锈钢针203体依次通过丙酮溶液、盐酸溶液和氢氧化钠溶液,之后放入到装有RO水的超声波清洗机中进行清洗,清洗结束后晾干备用,有利于去除不锈钢针体203表面的残留杂质,有利于后续涂层和不锈钢针体203表面进行附着;Pass the prepared
S3.针体涂膜S3. Needle body coating
将不锈钢针体203固定到涂膜模具内,配制涂膜材料的溶胶先驱体,通过注射器将溶胶先驱体注入到模具内,反复循环多次直至不锈钢针体203表面涂层均匀,并将针尖及针柄部位涂层去除,有利于为该针灸针保留一定的导电能力,使其可以作为电针进行使用;Fix the stainless
S4.绝缘层烧制S4. Insulation layer firing
将表面带有涂层的不锈钢针体203放入马弗炉中进行烧制,使不锈钢针体203表面形成绝缘层202,有利于使绝缘层202附着成型;Put the coated stainless
S5.握柄安装S5. Grip installation
将握柄102及螺纹管101的模具固定安装到不锈钢针体203上端3cm处,将ABS树脂加热至熔融,倒入模具中,将整体放入冷却箱中进行冷却,冷却至室温后脱模,有利于将该针灸针的握柄102和螺纹管101进行固定安装;Fix the
S6.药膜制备S6. Drug film preparation
取丹参及藏红花适量,加入5倍量的体积分数80-95%乙醇回流提取5次,每次3小时,合并提取液,浓缩,干燥,得到丹参及藏红花提取物,有利于最大程度上将藏红花和丹参中的有效成分进行提取保留;Take an appropriate amount of Salvia miltiorrhiza and saffron, add 5 times the volume fraction of 80-95% ethanol to reflux and extract 5 times, each time for 3 hours, combine the extracts, concentrate, and dry to obtain the extracts of Salvia miltiorrhiza and saffron, which is beneficial to the maximum extent. Extract and retain the active ingredients in Salvia miltiorrhiza;
S7.药膜喷涂S7. Membrane spraying
取丹参及藏红花提取物2-3倍量的体积分数3%的PLGA溶液,将提取物和PLGA溶液进行混合,搅拌溶解,采用喷雾法将混合后的溶液均匀喷涂于不锈钢针体的表面,喷涂完成后,放置于真空干燥箱中干燥15-20小时,即得到该针灸针,有利于使药膜201均匀分布在该针灸针的表面,提升其药物有效成分的释放效果。Take the 3% PLGA solution with a volume fraction of 2-3 times the amount of salvia miltiorrhiza and saffron extract, mix the extract and PLGA solution, stir and dissolve, and spray the mixed solution evenly on the surface of the stainless steel needle body by spraying, spray After completion, place it in a vacuum drying oven to dry for 15-20 hours to obtain the acupuncture needle, which is conducive to evenly distributing the
S1中,电化学法所用的腐蚀液为氯化钠溶液,腐蚀电压为15V,腐蚀时间为8min,有利于确保该针灸针的针尖可以一次成型,提升该针灸针的使用效果,S2中超声波清洗机的清洗频率为28-40KHz,功率为480-650W,清洗时间为15-20min,有利于对针灸针表面的产流杂质进行彻底清除,便于后续涂层进行依附,S3中,涂膜材料的溶胶先驱体为二氧化钛溶胶先驱体或二氧化硅溶胶先驱体,绝缘层202为二氧化钛涂层或二氧化硅涂层,有利于确保该针灸针的绝缘效果及对人体的适应性,S4中,马弗炉的烧结温度为800-1000℃,烧结时间为60-80min,有利于确保该针灸针的绝缘层202可以快速附着成型,S5中,ABS树脂的熔融温度为250-280℃,有利于确保ABS树脂的安装连接效果,S6中,PLGA溶液乙交酯、丙交酯和氯仿的质量比为1:1.5:100,喷射速率为0.6-1m/s,喷药时间为25min,有利于确保藏红花和丹参中的有效成分可以充分附着到该针灸针的表面,提升其医疗效果。In S1, the corrosion solution used in the electrochemical method is sodium chloride solution, the corrosion voltage is 15V, and the corrosion time is 8 minutes, which is beneficial to ensure that the needle tip of the acupuncture needle can be formed at one time and improve the use effect of the acupuncture needle. In S2, ultrasonic cleaning The cleaning frequency of the machine is 28-40KHz, the power is 480-650W, and the cleaning time is 15-20min. The sol precursor is a titanium dioxide sol precursor or a silica sol precursor, and the insulating
尽管已经示出和描述了本发明的实施例,对于本领域的普通技术人员而言,可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型,本发明的范围由所附权利要求及其等同物限定。Although the embodiments of the present invention have been shown and described, those skilled in the art can understand that various changes, modifications and substitutions can be made to these embodiments without departing from the principle and spirit of the present invention. and modifications, the scope of the invention is defined by the appended claims and their equivalents.
Claims (8)
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| JP2003010284A (en) * | 2001-07-03 | 2003-01-14 | Seirin Kk | Needle for electrifying therapy |
| KR20090060643A (en) * | 2007-12-10 | 2009-06-15 | 김근식 | Hanpolie surface-treated with titanium oxide |
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