CN108324273A - 一种肌电检查针 - Google Patents
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Abstract
本发明公开了一种肌电检查针,包括针体和针柄,针体一端固接在针柄端部,针体为同心圆针电极,包括针管和针芯,针管内表面和针芯表面均设有绝缘层,针管内表面绝缘层和/或针芯表面绝缘层上或者针管内表面绝缘层与针芯表面绝缘层之间设有一个或数个离子选择性微电极和/或光纤探针。本发明将传统肌电检查针与离子选择性微电极和/或光纤探针相结合,能够在进行肌电图测定的同时检测病变肌肉区化学信号的改变,帮助医生及时作出疾病诊断。
Description
技术领域
本发明属于医疗器械领域,具体涉及一种用于评价肌肉的病变情况的肌电检查针。
背景技术
肌电图(electromyography)(简称EMG),是指应用电子学仪器记录肌肉静止或收缩时的电活动,及应用电刺激检查神经、肌肉兴奋及传导功能,是记录神经和肌肉生物电活动以判断其功能的一种电诊断方法。通常采用两种进行描记:一种是表面导出法,即把电极贴附在皮肤上导出电位的方法;另一种是针电极法,即把针电极刺入肌肉导出局部电位的方法。这种方法能分别记录肌肉每次的动作电位,而根据从每秒数次到二、三十次的肌肉动作电位情况,发现频率的异常,据此评价肌肉的病变情况。
针电极是一种常用的医用传感器件,临床上经常使用的针电极包括同心圆针电极、单极针电极和单纤维针电极。同心圆针电极是肌电图机的配用电极,应用于电刺激检查神经是否受损以及损害性质和程度,使用时,针电极针体插入患者肌肉内,针体收集患者肌肉收缩所产生的微弱电信号然后通过导电电极和导联线连接至终端,医生通过分析经处理过的电信号和波形来对病人进行诊断。
常用的针电极是同心圆针电极,即在针管中心穿一根绝缘金属细丝,针管内充填满绝缘材料(如环氧树脂),再用锉刀锉针的顶部,以使中心金属丝露出作为触点。内丝一般由镍铬合金、银或白金组成,直径约0.1mm。针尖为椭圆形,面积为150μm×600μm。细丝另一端接同轴电缆的芯线,针身接到同轴电缆的屏蔽线上。这种电极具有屏蔽作用,亦称之为屏蔽针电极。
目前上述针电极仅可满足临床常规检测需要,如四肢及躯干等较大肌肉,而对于头面部或其他较小的肌肉,患者普遍不耐受检查,且现有针电极不能反映病变肌肉区化学信号的改变。
发明内容
本发明针对现有技术不足,提供了一种能够同时检测化学信号和电信号的新型肌电检查针。
本发明具体技术方案如下:
一种肌电检查针,包括针体和针柄,针体一端固接在针柄端部,针体为同心圆针电极,包括针管和针芯,所述针管为参考电极,针芯为记录电极,所述针管和针芯分别连接导线经针柄内部与肌电图及诱发电位仪连接,所述针管内表面和针芯表面均设有绝缘层,针管内表面绝缘层和/或针芯表面绝缘层上或者针管内表面绝缘层与针芯表面绝缘层之间设有一个或数个离子选择性微电极和/或光纤探针,所述离子选择性微电极具有头端和末端,头端接收离子浓度变化信号,末端连接导线穿过针柄内部与电位计连接;所述光纤探针具有头端和末端,头端探测化学物质信号,末端在针柄内部或穿过针柄内部与出射光纤耦合并接,所述出射光纤与光谱仪连接;或者所述光纤探针末端在针柄内部或穿过针柄内部与入射光纤和出射光纤耦合并接,入射光纤与光源发生器连接,出射光纤与光谱仪连接。
优选的,所述离子选择性微电极和/或光纤纳米探针沿针体轴向分布。
本发明所述离子选择性微电极优选为钠离子、钾离子、钙离子型离子选择性微电极。
本发明所述光纤探针为免疫生物传感器,所述光纤探针表面固定有待测物质相应的抗原或抗体。所述待测物质为前列腺素、白三烯、P物质中的一种或几种。
优选的,所述光纤探针选自光纤纳米荧光生物传感器、光纤纳米免疫传感器、光纤SPR传感器中的一种或几种。
本发明的一个优选方案,所述针体长20~40mm,优选25mm,针管外径为 0.3-0.5mm,优选0.4mm,针芯面积150×600μm,所述离子选择性微电极头端直径为1-10μm,优选2.5μm,所光纤探针头端直径为10 nm~600μm。
本发明所述离子选择性微电极为本领域熟知的微电极,可采用文献《钠离子选择性双管微电极的研制及应用》(庄云龙.中国生物医学工程学报,1991,第10卷,第2期)、《钙离子选择性微电极在口腔医学研究中应用的初步探讨》(刘鲁川.牙体牙髓牙周病学杂志.1997年9月第7卷第3期)等文献公开的结构或者方法制备。
本发明所述的光纤探针是一种基于光学原理的生物免疫传感器,是直接将抗体抗原免疫反应转变为可检测的连续信号,省去了对抗体或抗原蛋白分子的标记过程,保持了蛋白的生物活性,活动元件少、无电接触、抗电磁干扰能力强,通过参数控制,能够获得很高的稳定性。
本发明所述光纤探针可以选自光纤纳米荧光生物传感器、光纤纳米免疫传感器、光纤SPR传感器中的一种或几种。
纳米探针是一种能探测单个活细胞的新型超微生物传感器,探头尺寸仅为纳米量级(1-100nm)。作为生物传感技术领域迅猛发展起来的一项新型传感器,具有体积小、能在细胞内实时测量、对细胞无损伤或微损伤等诸多特点,是研究单细胞最基本的技术。在生物、医学、环境监测等多种领域得到广泛应用。
光纤纳米荧光生物传感器可以用于检测一些自身能发荧光的蛋白质或者通过标记或修饰使本身不能发荧光的生物物质发生荧光通过光纤捕捉反馈荧光信号,再通过光谱仪对结果进行分析。(Barke. Fiber-optic nitric oxide -selective biosensors andnanosensors [ J ] . Anal Chem ,1998 , 70( 5):971-976.Barke. Development andcellular appl i cations of fiber optic nitric oxide s ensors bas ed on a gold-absorbed fluorophore[ J ] . Anal Chem ,1998 , 70( 23): 4902-4908.)。
光纤免疫传感器是将光学与光子学技术应用于免疫法,利用抗原抗体特异性结合的性质,将感受到的抗原量或抗体量转换成可用光学输出信号的一类传感器,这类传感器将传统的免疫测试法与光学、生物传感技术的优点集为一身,使其鉴定物质具有很高的特异性、敏感性和稳定性。而光纤纳米免疫传感器是在其基础上将敏感部制成纳米级,既保留了光学免疫传感器的诸多优点,又使之能适用于单个细胞的测量。
光纤纳米免疫传感器,传感器头部的生物探针上结合了特异性单克隆抗体,通过抗原抗体特异性结合,能够检测单个细胞内的生物化学物质。首先,使用光纤拉制仪将石英光纤拉得极为细小( 10~100 nm),然后将光纤头部硅烷化,目的是为抗体产生黏附位点。将抗体结合到光纤头部后后将光纤全长( 结合了特异性抗体的光纤头部除外) 镀银以防止光漏出(周李承.光纤纳米生物传感器的现状及发展.传感器技术.2002年第21卷第12期)。
可将光纤末端与熔接上一段耦合了激光的光纤,激光传输到纳米光纤探针的尖端与待测物质接触,从而激发待测物质的光谱,光学信号经光纤捕捉收集,反馈给光谱仪进行分析。或者将光纤末端与入射光纤和出射光纤耦合并接,形成“Y”型光纤,入射光纤与光源发生器连接,出射光纤与光谱仪连接。(任宏亮.纳米光纤探针的研制及应用.郑州大学)。
表面等离子体共振(Surface Plasmon Resonance,SPR)传感器对界面处介质成分的微小变化非常敏感,已广泛应用于在表面检测、生物医学、环境监测等诸多领域。光纤SPR 检测系统通常由宽带光源、Y 型光纤耦合器、光纤 SPR 传感探针、光纤光谱仪、计算机及其相关数据采集和处理模块组成。(冯李航.光纤新型结构 SPR传感器开发及检测应用研究. 南京航空航天大学)。应用SPR生物传感技术进行灵敏快速的IgG检测,在疾病诊断或者抗体药物生产过程监控等领域均有潜在的应用价值。(刘强.基于光导毛细管器件的SPR生物传感器及IgG检测. 大连理工大学学报.2015,Vol.55,No.4)。
本发明优点
本发明将传统肌电检查针与离子选择性微电极和/或光纤探针相结合,通过离子选择性微电极检测肌肉细胞内特殊离子的浓度变化,通过将伤害性疼痛介质前列腺素、白三烯、P物质的特异性抗体结合固定到光纤探针的头端,检测前列腺素、白三烯、P物质等化学物质的变化,将感受到的抗原量或抗体量转换成可光学输出信号,并进行分析。能够在进行肌电图测定的同时检测病变肌肉区化学信号的改变,帮助医生及时作出疾病诊断。
此外,目前临床上采用的肌电检查针可用于检查较大肌肉的电信号采集,但对较小、较薄的肌肉尚无合适肌电采集针,尤其对于头面部肌肉疼痛、肌张力增高的肌电信号采集缺少有效工具,随着病情进展,患者普遍不耐受现有针电极检查。例如临床上普通使用的一次性针电极(规格:37mm×0.46mm(26G)),此型号为常用成人肌电针检查,缺点:头面痛患者普遍不能耐受。而规格为25mm×0.30mm(30G))的检查针,常用于儿童肌电信号采集,虽然疼痛病人可耐受;但是较短不易检查到深部肌肉。本发明的肌电检查针针体长20~40mm,优选25mm,针管外径为 0.3-0.5mm,优选0.4mm,针芯面积150×600μm,所述离子选择性微电极头端直径为1-10μm,优选2.5μm,所光纤探针头端直径为10 nm~600μm,可用于头面痛患者深浅层肌肉与筋膜检测。
附图说明
图1为本发明所述肌电检查针结构示意图。
图2为本发明所述肌电检查针针体局部放大结构示意图。
图3为本发明所述肌电检查针连接检测设备使用示意图。
具体实施方式
在本发明中所使用的术语,除非另有说明,一般具有本领域普通技术人员通常理解的含义。
下面结合具体实施例并参照数据进一步详细描述本发明。应理解,该实施例只是为了举例说明本发明,而非以任何方式限制本发明的范围。
在以下实施例中,未详细描述的各种过程和方法是本领域中公知的常规方法。下述实例中所用的材料、试剂、装置、仪器、设备等,如无特殊说明,均可从商业途径获得。
下面结合具体实施例对本发明进一步说明。
实施例1
一种肌电检查针,包括针体2和针柄1,针体一端固接在针柄端部,针体为同心圆针电极,包括针管3和针芯4,所述针管为参考电极,针芯为记录电极,所述针管和针芯分别连接导线11经针柄内部与肌电图及诱发电位仪7连接,所述针管内表面和针芯表面均设有绝缘层,针管内表面绝缘层和/或针芯表面绝缘层上或者针管内表面绝缘层与针芯表面绝缘层之间设有一个或数个离子选择性微电极5和光纤探针6,所述离子选择性微电极具有头端和末端,头端接收离子浓度变化信号,末端连接导线14穿过针柄内部与电位计10连接;所述光纤探针具有头端和末端,头端探测化学物质信号,末端在针柄内部或穿过针柄内部与出射光纤12耦合并接,所述出射光纤12与光谱仪8连接;或者所述光纤探针末端在针柄内部或穿过针柄内部与入射光纤13和出射光纤12耦合并接,入射光纤13与光源发生器9连接,出射光纤12与光谱仪8连接。
本发明所述肌电检查针在使用前,将伤害性疼痛介质前列腺素、白三烯、P物质的特异性抗体预先结合固定到光纤探针的头端。使用时,将针体插入患者肌肉内,针管作为参考电极,针芯作为记录电极针体收集患者肌肉收缩所产生的微弱电信号,将信号传输至肌电图及诱发电位仪。同时,采用离子选择性微电极检测肌肉细胞内钠离子、钾离子、钙离子的浓度变化,并通过导线将信号传输给电位计。可使用荧光标记或修饰的特异性抗体,当特异性抗体与前列腺素、白三烯、P物质等伤害性疼痛介质结合时,光纤捕捉荧光,并由出射光纤反馈荧光信号至光谱仪对结果进行分析。或者,将特性性抗体结合到光纤头端,光纤末端与入射光纤和出射光纤耦合并接,形成“Y”型光纤,激光通过入射光纤传输到纳米光纤探针的头端与待测物质接触,从而激发待测物质的光谱,光学信号经出射光纤捕捉收集,反馈给光谱仪进行分析。医生通过综合分析经处理过的电信号、光信号和波形等来对病人进行诊断。
Claims (8)
1.一种肌电检查针,包括针体和针柄,针体一端固接在针柄端部,针体为同心圆针电极,包括针管和针芯,所述针管为参考电极,针芯为记录电极,所述针管和针芯分别连接导线穿过针柄内部,其特征在于所述针管内表面和针芯表面均设有绝缘层,针管内表面绝缘层和/或针芯表面绝缘层上或者针管内表面绝缘层与针芯表面绝缘层之间设有一个或数个离子选择性微电极和/或光纤探针,所述微电极连接导线穿过针柄内部;所述光纤探针在针柄内部或穿过针柄与出射光纤耦合并接;或者所述光纤探针在针柄内部或穿过针柄与入射光纤和出射光纤耦合并接。
2.如权利要求1所述的肌电检查针,其特征在于所述离子选择性微电极和/或光纤纳米探针沿针体轴向分布。
3.如权利要求1所述的肌电检查针,其特征在于所述离子选择性微电极为钠离子、钾离子、钙离子型离子选择性微电极中的一种或几种。
4.如权利要求1所述的肌电检查针,其特征在于所述光纤探针为免疫生物传感器,所述光纤探针表面固定有待测物质相应的抗原或抗体。
5.如权利要求1所述的肌电检查针,其特征在于所述待测物质为前列腺素、白三烯、P物质中的一种或几种。
6.如权利要求1所述的肌电检查针,其特征在于所述光纤探针选自光纤纳米荧光生物传感器、光纤纳米免疫传感器、光纤SPR传感器中的一种或几种。
7.如权利要求1所述的肌电检查针,其特征在于所述针体长20~40mm,针管外径为0.3-0.5mm,针芯面积150×600μm,所述离子选择性微电极头端直径为1-10μm,所光纤探针头端直径为10 nm~600μm。
8.如权利要求7所述的肌电检查针,其特征在于所述针体25mm,针管外径为0.4mm,针芯面积150×600μm,所述离子选择性微电极头端直径为2.5μm,所光纤探针头端直径为10 nm~600μm。
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