CN114847936A - 柔性可植入式铂合金阵列型传感器 - Google Patents
柔性可植入式铂合金阵列型传感器 Download PDFInfo
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Abstract
本发明提供了一种柔性可植入铂合金阵列型传感器及其在医疗设备技术领域的应用,该传感器以柔性铂合金为电极材料,其可以直接作为传感器,或者作为传感器的基底,可以同时检测生物样本中各种离子、氧气、二氧化碳、酸碱度等呼吸代谢物、葡萄糖、乳酸等物质的含量。其具有制造工艺简单、检测准确度高等优点。
Description
技术领域
本发明属于医疗设备技术领域,具体而言,本发明涉及一种柔性可植入式铂合金阵列型传感器及其在医疗设备技术领域中的应用。
背景技术
即时检测(Point of Care testing,简称POCT)作为体外诊断行业的细分领域之一,具有即时、小型等优点。随着分级诊疗的推动,其在基层医院成为主角,在不断引导患者分流就诊的同时也不断提升基层医院的就诊水平与设备配置,促使产品小型化、检测即时化的POCT逐步打开了市场。
钠是细胞外液中最主要的阳离子,对人体内维护渗透压、酸碱平衡、水平衡以及调节细胞膜内外电位差有重要意义。钾是细胞内液最主要的阳离子,在肌肉功能、保存酸碱平衡、水平衡和渗透压方面起着重要的作用。临床上,钙离子对以下疾病的诊断或监护有重要意义:甲状旁腺、代谢性酸碱中毒、高血压监控、肾脏疾病等。离子镁是细胞内含量第二高的阳离子,能量转换的ATP循环密切相关。氯是存在于细胞外最主要的阴离子,在人体内影响细胞渗透压、维护酸碱平衡和水平衡。酸碱度、血氧、二氧化碳分压的检测是呼吸系统非常重要的诊断指标。血糖、乳酸等更是能反应人体新陈代谢的重要指标。因此POCT产品如果能即使反馈患者的这些指标,就能让患者得到及时的治疗。
但是目前市面上POCT产品的体积都较大,不方便随身携带。而且操作都需要抽取血样,这限制了POCT产品的使用场景。虽然很多POCT产品满足应用于临床检测,但是很难连续的反应患者实时的指标变化。专利CN 105361891公开了一种监测鱼眼球组织液内葡萄糖传感器的方法。把传感器放置在眼球下部,检测眼球组织液内的葡萄糖浓度,将其换算成血液中的葡糖糖浓度,这种方法不需要抽取血样,而且可以实现实时检测。专利CN105380669B公开了一种连续血糖监测用长寿命植入式葡萄糖传感器。这种也是可以连续检测患者体内血糖浓度的变化。专利CN208693260U公开了一种新型医用pH阻抗导管,其可以连续检测患者的食道内pH值。以上的发明都对某一单独的指标实现了连续、实时的检测。但是每种指标的电极基底,传感器的制备方法都不一致。并且市面上能实现连续、实时的检测传感器大多以葡糖糖、pH为主。本发明提供了一种电极基底,在其上面覆盖传感膜成功的制备出的传感器,可以满足绝大多数生化指标的检测。为未来实时、连续检测患者体内各种生化指标提供了一种传感器的制备方法。
发明内容
为了克服现有技术中存在的缺点与不足,本发明提供了一种柔性可植入铂合金阵列型传感器。阵列型传感器是由底座以及电极构成。其中有2个或2个以上电极阵列式有规律或者无规律的排列在底座上。传感器底座是由不导电材料构成,优选新型无机材料,更优选PP(聚丙烯),PE(聚乙烯),PVC(聚氯乙烯),或PET(聚对苯二甲酸乙二醇酯)材料。底座厚度一般不超过500mm,优选不超过50mm。电极是由铂合金材料构成,该铂合金可以采用普通传感器中使用的市售铂合金材料,优选铂铱合金,其直径或者厚度不超过2.0mm。铂合金可以直接作为传感器电极,也可以作为传感器电极的基底。在同一样本溶液中,本发明提供的铂合金阵列型传感器可以用于,包括但不限于水溶液,一种或者多种缓冲溶液,血清、血浆、全血、汗液、尿液等生物样本中的钠、钾、钙、镁、或氯等离子,葡萄糖、乳酸等新陈代谢物,氧气、酸碱度等呼吸代谢物的同时检测,检测时各个靶标之间不相互干扰。
本发明提供的一种柔性可植入铂合金阵列型传感器。传感器的种类包括但不限于钾、钙、镁、或氯等离子选择性传感器以及葡萄糖、乳酸、氧气、酸碱度、或二氧化碳等相关物质传感器。阵列型是指把上述多种传感器排列在同一基底板上。按照检测的需求,不同类型传感器之间可以相互组合。每个铂合金阵列型传感器上可以有≥≥个用于检测的传感器。柔性是指铂合金直径或者厚度≤径2.0mm,物理性质非常柔软。可植入式是指由于本发明的铂合金阵列型传感器非常柔软和细,可以通过手术的手段将铂合金阵列型传感器植入在受试者的表皮组织下或者血管内。本发明传感器使用的铂合金可以掺杂其他贵金属,包括但不限于,铱、金、铑、锇、钛、镍、银、铜、铁等其他金属物质。
本发明提供了一种柔性可植入铂合金阵列型传感器,所述铂合金是指铂与其他贵金属的合金。其中铂合金可以作为单独的电极也可以同时作为电极基底。本发明所使用的铂合金阵列型传感器优选铂铱合金,铂铑合金,铂钯合金,铂金合金电极,更优选铂铱合金电极。这些电极合金可以从A-M Systems平台购买。
本发明提供一种柔性可植入铂合金阵列型传感器,其中包含的pH和/或pO2传感器。本发明的铂合金,经过清洁后,不需要增镀其余的传感膜就可以直接作为传感器检测样本中的酸碱度或氧气分压。这种裸铂合金阵列型传感器在使用前可以用盐酸和乙醇清洁,自然晾干后,放置在通风干燥处待用。
另一方面,本发明的传感器经过镀膜处理后可以作为离子选择性传感器。其可以用于检测样本中的钠,钾,钙,镁,氯等离子浓度。离子选择性传感器包含电极基底(1),传感膜层(2)。所述的传感膜层(2)为离子选择性传感膜层。电极基底同样也是裸铂合金电极,在使用前可以用盐酸和乙醇清洁,自然晾干后,采用浸渍提拉的方法在裸铂合金阵列型传感器表面镀相应的离子选择性传感膜层。离子选择性传感膜层在室温下自然挥发成膜后,在通风干燥处保存。
另一方面,本发明的传感器经过镀膜处理后还可以作为酶传感器。其可以用于检测样本中的葡萄糖、乳酸等相关物质浓度。酶传感器包含电极基底(1),传感膜层(2),所述的传感膜层(2)为酶层。电极基底同样也是裸铂合金电极,在使用前可以用盐酸和乙醇清洁,自然晾干后,采用浸渍提拉的方法在裸铂合金阵列型传感器表面镀相应的酶层。酶层在20~70℃下干燥1~3h后在通风干燥处保存。
本发明的铂合金,经过清洁后可以直接作为传感器检测样本中的酸碱度或氧气分压。也可以经过镀膜处理后,作为离子选择性传感器或酶传感器检测样本中的离子浓度、葡萄糖或乳酸浓度。在同一样本溶液中,铂合金阵列型传感器可以同时检测多种靶标(钠,钾,钙,镁,氯、葡萄糖、乳酸、氧气或酸碱度等),检测时靶标之间不相互干扰。铂合金阵列型传感器也可以检测不同种的样本,比如水溶液、一种或者多种缓冲溶液、血清、血浆、全血、汗液或尿液等生物样本。本发明的铂合金阵列型传感器可以植入生物体内或者皮肤组织下,连续性的检测生物体内多种生化指标的变化趋势,为其判断身体状态提供良好的依据。
本发明的有益效果如下:
1、本发明使用的铂合金阵列型传感器,可以在同一样本中同时检测多种生化指标。
2、本发明使用的铂合金阵列型传感器,可以在不同的样本中检测同一种生化指标。
3、本发明使用的铂合金阵列型传感器,制备方法简单,一次操作即可完成反应试剂在电极上的成膜。反应试剂原料易得,成本低,配方成熟,有利于工业化生产,实用性强。
4、本发明使用的铂合金阵列型传感器,检测范围宽,灵敏度高,可以实现连续实时的检测。
5、本发明使用的铂合金材料,制备工艺简单。
附图说明
图1是电极结构示意图,其中电极基底(1),传感膜层(2)。
图2是阵列型传感器示意图,其中图2(A)为正视图,图2(B)为后视图。
图3是铂合金阵列型传感器的校准曲线,其中图3(C)对应pH传感器,图3(D)对应pO2传感器。
图4是纯铂电极传感器的校准曲线,其中图4(E)对应pH传感器,图4(F)对应pO2传感器;
图5是以铂合金阵列型传感器为基底的传感器的校准曲线。其中图5(G)对应K离子传感器;图5(H)对应Ca离子传感器;图5(I)对应Cl离子传感器;图5(J)对应葡萄糖传感器;图5(K)对应乳酸传感器。
具体实施方式
下面通过具体实施例对本发明所述的技术方案给予进一步详细的说明,但有必要指出以下实施例只用于对发明内容的描述,并不构成对本发明保护范围的限制。
实施例1:本发明传感器测定样本中pH和pO2
本发明的铂合金阵列型传感器可以作为单独的传感器。优选铂铱合金电极,本实施例1采用铂铱合金电极,测定生物样本中的pH值或者pO2分压。本实例中的传感器不需要额外在电极表面进行修饰,只需要简单的清洁即可。
实验过程:pH测定的方法是:在室温下将铂合金阵列型传感器浸在不同pH值的缓冲液中,用6通道EMF装置进行电位值的测量。使用双液接Ag/AgCl参比电极(内装3M KCl,外溶液为1M醋酸锂)。实验数据中用到的离子活度系数参照德拜-休克尔方程计算,所有电位值均经过亨德森方程校正,所有数据均为5个平行电极测得数据的平均值。pH电极校准曲线的原始数据如表1所示。从图3(A)可以得到,电极对pH在1~9范围内有良好的线性响应(R=0.9920)。
pO2的检测方法在室温下将铂合金阵列型传感器浸在不同氧分压的缓冲液中,以Ag/AgCl电极作参比和对电极,用电化学工作站恒电位法进行电流-时间曲线的测量。所有数据均为5个平行电极测得数据的平均值。pO2电极校准曲线的原始数据如表2所示。从图3(B)可以得到,电极对氧分压在46-840mmHg范围内有良好的线性响应(R=0.983)。
纯铂电极测试样本中的不同pH值,pH电极校准曲线的原始数据如表1所示。纯铂电极测试样本中的不同pO2分压,pO2电极校准曲线的原始数据如表2所示。铂铱合金电极测定缓冲溶液中的不同pH值或者pO2分压的性能、检测范围都与纯铂电极的性能几乎一致。这表明在性能上,铂铱合金可以替代铂金作为电极检测生物样本中pH值或者pO2分压。
表1:pH电极校准曲线的原始数据
表2:pO2电极校准曲线的原始数据
实施例2:本发明传感器测定样本中离子、乳酸或葡萄糖的浓度
铂合金阵列型传感器,优选铂铱合金电极,实施例2采用铂铱合金电极。铂铱合金可以作为电极基底,在上面修饰各种传感膜,用来检测生物样本中的物质含量。
本实例的传感器结构包括:
电极基底(1),传感膜层(2)根据检测的样品不同,所述的传感膜层可以包括离子选择性传感膜或者酶层。
本实施例传感器的制备方法如下:
参考专利CN109862830A或CN108593745A配置酶液或者离子传感膜溶液,通过浸渍提拉的方法使液态的离子传感膜溶液或者酶液在铂铱合金电极基底表面成膜。膜层在室温或者45层在下自然挥发过夜后,放在干燥器中保存。
检测方法同上一实施例。K离子、Ca离子、Cl离子、葡萄糖、乳酸电极的校准曲线原始数据分别如下表3-7所示。图4为不同传感器的校准曲线。图4显示对于离子选择传感膜而言,在10-3~10-1M浓度范围内有很好的的响应。对于酶膜传感器而言,拥有较宽的检测范围,而且在检测范围内的线性较好。
表3:K离子电极校准曲线的原始数据
表4:Ca离子电极校准曲线的原始数据
表5:Cl离子电极校准曲线的原始数据
表6:葡萄糖电极校准曲线的原始数据
表7:乳酸电极校准曲线的原始数据
实施例3:本发明传感器测定全血样品中的生化指标
本实施例的柔性可植入铂合金阵列型传感器适用于全血样品中电解质、血气以及代谢物的同时快速测定。所述的铂合金阵列型传感器由镁离子传感器、氯离子传感器、钠离子电极、钾离子电极、钙离子电极、pH电极、氧气电极、二氧化碳电极、血糖电极、乳酸电极和参比电极组成。将铂合金阵列型传感器置于全血样本中,得到信号值。分别利用不同传感器的线性相关性,通过信号值计算得到相应的浓度值。与理论值(NOVA分析仪)计算回收率。结果如表8所示。结果显示,本发明的传感器之间不相互干扰,每种传感器在不同样本中的检测都具有很高的准确性。
表8:本发明的传感器在不同样本中的检测的准确性
检测项目 | 缓冲液 | 全血 | 血清 |
钠离子 | 102.2% | 94.8% | 96.8% |
钾离子 | 98.7% | 93.5% | 97.4% |
钙离子 | 92.3% | 95.3% | 103.5% |
镁离子 | 108.3% | 116.4% | 103.4% |
氯离子 | 91.3% | 106.2% | 104.8% |
pH值 | 97.5% | 103.2% | 102.5% |
pO2 | 98.6% | 108.3% | 103.5% |
葡萄糖 | 93.2% | 94.5% | 95.4% |
乳酸 | 102.4% | 98.6% | 97.4% |
Claims (15)
1.一种柔性可植入铂合金阵列型传感器,由底座以及电极构成,其特征在于:有2个或2个以上电极阵列式有规律或者无规律的排列在底座上。
2.根据权利要求1所述的传感器,其特征在于底座由不导电的材料构成,该材料选自聚丙烯,聚乙烯,聚氯乙烯,或聚对苯二甲酸乙二醇酯材料。
3.根据权利要求1或2所述的传感器,其特征在于电极是由铂合金材料构成,该铂合金中含有其他贵金属,所述贵金属选自铱、金、铑、锇、钛、镍、银、铜、或铁中的一种或多种,铂合金优选铂铱合金。
4.根据权利要求3的传感器,其特征在于,铂合金作为电极基底或作为单独的电极。
5.根据权利要求1-4中任一项所述的传感器,其特征在于,所述电极是由电极基底和传感膜组成。
6.根据权利要求1-5中任一项所述的传感器,该传感器是离子选择性传感器。
7.根据权利要求1-5中任一项所述的传感器,该传感器是酶传感器。
8.根据权利要求1-3中任一项所述的传感器,其底座的厚度不超过20mm,电极的直径或者厚度不超过2.0mm。
9.权利要求1-8中任一项所述的传感器的制备方法,包括首先清洗铂合金电极,再将电极的一头插入底座中,电极规则或不规则地排列在底座上,优选2X2,3X2,4X2,5X2或6X2的排列方式。
10.权利要求1-8中任一项所述的传感器的制备方法,首先清洗铂合金电极,再在铂合金电极的一头镀一层传感膜,然后将电极的另一头插入底座中,电极规则或不规则地排列在底座上,优选2X2,3X2,4X2,5X2或6X2排列方式。
11.根据权利要求10所述的传感器的制备方法,其镀膜方式为浸渍-提拉镀膜方法。
12.根据权利要求9-11中任一项所述的传感器的制备方法,在底座上利用工具打出需要电极的孔数,再将电极未镀传感膜的一头插入孔中,其中需要预留出大约2mm的长度,用来连接信号检测器。
13.权利要求1-8中任一项所述的传感器的用途,该传感器在同一样本溶液中可以同时检测多种靶标,其靶标选自钠、钾、钙、镁、氯、等离子、葡萄糖、乳酸、氧气或酸碱度。
14.根据权利要求13所述的传感器的用途,其样本溶液选自水溶液、一种或者多种缓冲溶液、血清、血浆、全血、汗液或尿液。
15.根据权利要求13或14所述的传感器的用途,其中不同靶标之间检测结果不相互干扰。
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