CN103687537B - Ecg电极连接器 - Google Patents
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Abstract
本发明提供一种ECG电极连接器(1400、1500、1600)。连接器组件(1400、1500、1600)包括壳体(1424、1524),所述壳体具有设置于它的内表面(1431、1531)的至少一部分上的射线可透的导电涂层。射线可透的引线导体(1477、1577、1677)从所述壳体(1424、1524)的近侧端部延伸并且可操作地联接至所述射线可透的导体(1432、1532)。接合构件(1436、1536、1636)可枢转地设置于所述壳体(1424、1524)内,以将连接器(1400、1500、1600)保持于固定至患者的身体的ECG电极上。连接器(1400、1500、1600)改善ECG电极的电和机械联接并且适合在成像过程期间使用。
Description
技术领域
本发明涉及生物医学电极,特别地,涉及用于在成像过程期间执行专利的生物医学监控的射线可透的生物医学电极连接器和射线可透的引线。
背景技术
心电(electrocardiograph:ECG)监护仪被广泛地用于获取包含表明与心脏和肺部系统相关联的电活动的信息的医学(亦即,生物电势)信号。为了获取所述医学信号,在各种位置中将ECG电极应用至患者的皮肤。在被放置于患者身上之后,所述电极通过一组ECG引线连接至ECG监护仪。所述ECG引线的远侧端部,或者说离患者最近的部分,可包括连接器,所述连接器适于可操作地连接至电极以从身体接收医学信号。ECG引线装置的近侧端部可操作地联接至ECG监护仪并将从身体所接收的医学信号提供至ECG监护仪。
典型的ECG电极组件可包括导电层和衬垫层,所述组件具有患者接触侧和连接器侧。电极片的接触侧可包括用于将电极固定至患者的身体的、生物相容的导电凝胶或粘合剂,用以便于患者的身体与电极组件之间的合适的电连接。所述电极片的连接器侧可包含具有球茎状轮廓的金属按扣,用以将电极片联接至ECG引线。在使用中,临床医师将保护覆盖层从电极侧去除以使凝胶或粘合剂暴露,将电极片固定至患者的身体,并通过将合适的ECG引线连接器按压或“卡合”至球茎状按扣上而将引线连接器附接至按扣,以实现电极和引线的机械和电联接。替代地,可使用通过对操作杆或其它机械锁定装置进行操纵而接合的ECG连接器。在使用之后,临床医师随后通过从电极片拉出或“松开”连接器或者通过松开操作杆或其它锁定机构而将ECG引线连接器从电极片去除。
已经通过医学协议确立了电极在患者上的放置。公共协议要求电极按照5-引线的构造方式放置:在与上部胸腔上的每个锁骨相邻处放置一个电极,在与患者的左下部腹腔相邻处放置第三电极,在与胸骨相邻处放置第四电极,以及在患者的右下部腹腔上放置第五电极。
在某些程序期间,可能需要监控正在经历成像(例如,CT扫描或MRI)的患者的生物学(例如,ECG)参数。传统的ECG连接器和通常与其相关联的引线装置的使用在这些应用中可能具有缺点,因为它们易于干扰成像系统。在一个实例中,ECG连接器和/或引线的某些构件可能被成像装置检测到并因此可能使临床医师和外科医师所依赖的可视图像模糊。在另一个实例中,当在MRI扫描器的强磁场内使用时,通常存在于ECG连接器中(例如在弹簧和夹子中)的含铁和/或磁性构件可能有潜在危险。
发明内容
在根据本发明所述的一个实施例中,提供一种ECG连接器组件,其包括具有内凹面的壳体。所述内凹面具有设置于其中的开口,所述开口的尺寸适于可操作地容置ECG电极片的按扣。射线可透的导体设置于所述内凹面的至少一部分上,并且射线可透的引线导体从所述壳体的近侧端部延伸并可操作地联接至所述射线可透的导体。ECG连接器组件包括可枢转地设置于所述内凹面上并具有接合面和枢轴的接合构件。所述接合构件能在其中所述接合面离所述开口的顶部部分较近的第一位置和其中所述接合面离所述开口的顶部部分较远的第二位置之间枢转。设置于所述壳体内的射线可透的弹性构件被构造成朝向所述第一位置偏置所述接合构件。
附图说明
附图并未按比例绘制。在附图中,在各图中所示出的每个相同的或几乎相同的构件由类似的符号代表。为了清晰的目的,可以不在每个附图中对每个构件进行标记。在下文中将参考附图对本发明的各个实施例进行描述,其中:
图1为传统的ECG电极连接器的分解图;
图2为图12A的传统的ECG电极连接器的示意图;
图3A为根据本发明的处于接合构造中的射线可透的ECG电极连接器的一个实施例的视图;
图3B为根据本发明的处于分离构造中的图3A的实施例的视图;
图3C为根据本发明的射线可透的ECG电极连接器的图3A实施例的按扣开口的详细视图;
图4A为根据本发明的处于接合构造中的射线可透的ECG电极连接器的另一个实施例的视图;
图4B为根据本发明所述的处于分离构造中的图4A实施例的视图;以及
图5为根据本发明的射线可透的ECG电极连接器的另一个实施例的视图。
具体实施方式
本发明在应用时并不限于在以下说明书中所阐述的或在附图中所示例说明的构件的构造和布置的细节。本发明能够以其它实施例实现并且能够按照各种方式实施或执行。此外,在本文中所使用的措词和术语是为了描述的目的并且不应被看作限制性。“包含”、“包括”、“具有”、“继续”、或“涉及”以及它们的变形在本文中的使用意欲涵盖随后所列出的物品以及其等同物以及另外的物品。
在下文中将参考附图对本发明的特定的实施例进行描述;然而,所公开的实施例仅仅为本发明的示例,本发明可以各种形式实施。为了避免不必要的或冗余的细节使本发明晦涩难懂,未对众所周知的功能或构造以及相应的内容进行具体描述。因此,在本文中所公开的特定的结构和功能细节不应被理解成限制性的,而应仅仅理解成权利要求的基础以及用于教会本发明所属领域的普通技术人员按照实际上任何合适的具体结构多方面地利用本发明的代表性基础。
在附图中以及在以下说明中,如传统的一样,术语“近侧”应当指仪器的离使用者更近的端部,而术语“远侧”应当指离使用者更远的端部。另外地,当在本文中使用时,例如“顶部”、“底部”、“上部”、“下部”、“左部”、“右部”、“顺时针”、“逆时针”、等等涉及方向的术语是用于参考附图和在其中所示的特征所进行的示例说明的目的。根据本发明所述的实施例可不受限制地按照任何方向实施。
本发明涉及适合在患者成像期间(例如,在CT扫描或MRI期间)使用的电极连接器。传统上可获得的电极连接器具有在图像上可能被检测到的和/或在暴露至特定的场(例如,磁场)时可能变危险的构件。
在图1和图2中示出了传统的电极连接器1320的一个实施例,其包括壳体1322,壳体具有上部构件1324和下部构件1326,并在上部构件1324和下部构件1326之间限定内腔1328。壳体1322由非导电材料制造而成,例如,将目标与其内的一个或多个导电元件电隔离的注射成型聚合物。上部构件1324和下部构件1326为通过任何合适的结合方法附接至彼此的分离的构件,所述结合方法例如为但不限于,粘合、超声波焊接或热焊接。上部构件1324和下部构件1326形成壳体1322的非导电元件。
传统的电极连接器的壳体1322包括引线端子1330,其通过任何合适的连接方法电连接至引线1304的相应的端部,所述合适的连接方法包括但不限于压接、软焊、或熔焊。引线端子1330由导电材料形成,所述导电材料典型地为例如不锈钢的金属。壳体1322支撑同样由导电材料形成的接触构件1332,其电连接至引线。在一个实施例中,引线由例如镀锡铜的导电金属形成。在另一个实施例中,接触构件的导电材料为例如不锈钢的金属。接触构件1332和引线端子1330可一体成型而成。接触构件1332限定形成于其中并与壳体1322的内腔1328相通的接触开口1334。接触开口1334包括第一接触开口部分1334a和第二接触开口部分1334b。第一接触开口部分1334a限定的内部尺寸或直径大于第二接触开口部分1334b的内部尺寸或直径。
传统的电极连接器的壳体1322进一步包括枢转地连接至它的操作杆1340。操作杆1340包括致动端部1336。如图2中所示,通过偏置构件1338将操作杆1340偏置至第一位置。偏置构件1338由例如不锈钢的弹性金属形成。操作杆1340包括接合区域1336a,接合区域从其突出以便在操作杆1340处于第一位置中时延伸跨过接触开口1334的第一接触开口部分1334a。在使用中,能将操作杆1340致动至第二位置,其中它的接合区域1336a不会阻塞或延伸跨过接触开口1334的第一接触开口部分1334a。例如,临床医师可将足以克服偏置构件1338的偏置力的手指压力应用至致动端部1336,由此致使接合区域1336a运动至如在此所描述的第二位置。
传统的ECG电极连接器1320适于连接至传统的卡合式生物医学电极(未明确地示出)。典型的卡合式生物医学电极包括电极凸缘或基座以及相对于电极基座横向地延伸的插入式按扣或端子。插入式按扣的端子可具有球茎状头,其中所述端子的上部部分具有比所述端子的下部部分大的横截面尺寸。相应地,在使用中,当电极连接器1320的操作杆1340处于第二位置中时,可将卡合式生物医学电极的插入式按扣端子的头插入接触开口1334的第一接触开口部分1334a中,并且可松开致动端部1336并且因此松开操作杆1340,以使得偏置构件1338使操作杆1340的接合区域1336a顶着插入式按扣(未明确地示出)的头运动,以将按扣的下部部分推入或插入接触开口1334的第二接触开口部分1334b中。偏置构件1338的偏置力有助于将按扣保持于接触开口1334的第二接触开口部分1334b内并因此阻止生物医学电极从ECG连接器1320的移除或分离。然而,因为引线端子1330、接触构件1332和偏置构件1338为金属的,因此当暴露至磁场时,这些构件中的一个或多个可能在图像中被检测到和/或变危险。
因此,本发明的一个方面提供一种可在患者的成像期间使用的电极连接器。在图3A、3B、和3C中示出了本发明的ECG电极连接器的一个实施例。鉴于此,并且为避免冗余信息使本发明晦涩难懂,此后将仅描述ECG电极连接器1400所特有的那些特征。
ECG电极连接器1400被构造为在受测患者正在经历成像过程(例如但不限于,MRI、CT、PET等等)时便于实现对ECG和其它生物学参数的监控。连接器1400包括具有内凹面1431的壳体1424,内凹面1431包括限定于其中的开口1434,开口1434朝向壳体的面向患者的表面开放。开口1434的尺寸适于接受患者电极的按扣的头的插入。壳体1424可由包括聚合材料在内的任何合适的非导电材料形成。连接器1400包括具有致动表面1439以及接合面1437的接合构件1436,致动表面1439可为具有一定轮廓的按钮。接合构件1436可围绕枢轴1415枢转,以使得接合面1437能够从其中接合面1437离开口1434的顶部部分1425较近的第一位置和其中接合面1437离开口1434的顶部部分1425较远的第二位置运动。通过此种构造方式,可在接合面1437和开口1434的侧壁之间在开口1434中捕获已经被插入开口1434中的按扣的球茎状头。接合构件1436包括设置于接合面1437和枢轴1415之间的加强件1438,其可具有弓形形状。
壳体1424的内凹面1431包括射线可透的导体1432,其便于实现在开口1434内所捕获的按扣和引线导体1477之间的生物学信号的传导。可通过任何合适的方式将射线可透的导体1432包括于表面1431中,所述任何合适的方式包括但不限于,如在壳体1424或其相关联的部分内所包含的导电涂层和/或导电材料。在某些实施例中,可通过将导电碳粉散布于内凹面1431上面来形成射线可透的导体1432。随后经由把热量和/或压力应用至形成内凹面1431的聚合材料来将所述导电碳粉熔合。在某些实施例中,可通过将射线可透的导电油墨应用至内凹面1431而形成射线可透的导体1432。在其它实施例中,射线可透的导体1432可包括固定至凹面1431的碳素纤维线。如图3C中所示,射线可透的导体1432可延伸至开口1434的侧壁1441的至少一部分上。
ECG电极连接器1400包括从它的近侧(例如,底)端部延伸的引线1475。引线1475包括围绕导体1477同轴地设置的外部绝缘体1476。导体1477由射线可透的导电材料形成,例如导电碳或导电碳单丝线。在某些实施例中,导体1477由一根或多根碳素纤维形成。剥除外部绝缘体的远侧部分,从而暴露导体的远侧部分1477’。导体1477的所暴露的部分1477’操作地连接至内凹面1431的射线可透的导体1432。可通过包括但不限于压接元件1478的任何合适的方式和/或通过射线可透的导电粘合剂连接导体1477’。在某些实施例中,导体1477的所暴露的部分1477’和射线可透的导体1432一体成型而成。应变消除部1479围绕引线1475的其中引线1475离开壳体1424的部分。
弹性构件1470朝向其中接合面1437离开口1434的顶部部分1425较近的第一位置偏置接合构件1436。叶状的弹性构件1470放置于在接合构件1436中所限定的凹槽1428和由壳体1424所提供的鞍座1472之间。弹性构件1470可由包括但不限于硅酮的射线可透的弹性体形成。弹性构件1470可具有任何形状以提供足够的力来容许接合构件1436的所期望的运动。弹性构件1470可具有任何规则的或不规则的形状,包括圆形、正方形、三角形、以及三叶草形状。在一个实施例中,弹性构件1470为叶状构件。在图3A和3B中所示的实施例中,叶状的弹性构件1470包括三叶轮廓,其中每个叶片以大致120°均匀地相间隔,然而,根据本发明所述的叶状的弹性构件1470可包括少于三个叶片或多于三个页片。另外地或替代地,叶状的弹性构件1470可包括未均匀地分布的和/或不规则地分布的叶片。弹性构件可整个都为实心的,或者包括一个或多个开口。叶状的弹性构件1470包括限定于其中的中心开口1471,中心开口1471具有大致对应于叶状的弹性构件1470的周界(例如,叶状轮廓)的轮廓的形状,和/或可包括一个或多个内部突起1481的形状。开口1471的尺寸与叶状的弹性构件1470的总尺寸的比率至少部分地确定叶状的弹性构件1470的弹性并且可便于在叶状的弹性构件1470和接合构件1436的组合的致动/压缩和松开/延伸期间实现对使用者的触觉反馈。例如,且非限制性地,当压缩和/或松开弹性构件1470时,在一个或多个内部突起1481之间的协作干涉可产生一个或多个振动,其转而可作为触觉反馈经由致动表面1439和/或经由壳体1424由使用者的指尖感测到。
在使用期间,使用者可使用例如指尖将力应用至致动表面1439,从而克服弹性构件1470的偏置力以使接合构件1436围绕枢轴1415稍微地沿逆时针方向旋转。依次地,接合面1437从开口1434的顶部表面1425进一步运动,这提供足够的间隙,以使得能够将按扣的球茎状头插入开口1434中。一旦按扣被插入开口1434中,使用者就可将手指压力从致动表面1439移除,于是弹性构件1470的偏置力致使接合构件1436围绕枢轴1415稍微地沿顺时针方向旋转,由此使按扣与开口1434的一部分电机械地接合,并因此使按扣与射线可透的导体1432和导体1477电联接。
在图4A和4B中示出了射线可透的ECG电极连接器1500的又一实施例。鉴于此,并且为避免冗余信息使本发明晦涩难懂,此后将仅描述ECG电极连接器1500所特有的那些特征。射线可透的电极连接器1500包括具有致动表面1539以及接合面1537的接合构件1536,致动表面1539可为具有一定轮廓的按钮。接合构件1536可围绕枢轴1515枢转,以使得接合面1537能够从其中接合面1537离开口1534的顶部部分1525较近的第一位置和其中接合面1537离开口1534的顶部部分1525较远的第二位置运动。通过此种构造方式,可在接合面1537和开口1534之间捕获已经被插入开口1534中的按扣的球茎状头。
弹性构件1570朝向其中接合面1537离开口1534的顶部部分1525较近的第一位置偏置接合构件1536。弹性构件1570可具有任何形状以提供足够的力来容许接合构件1536的所期望的运动。弹性构件1570可具有任何规则的或不规则的形状,包括圆形、正方形、三角形、以及三叶草形状,并且可不必整个都为实心的。在某些实施例中,弹性构件1570具有大致球形形状。球形的弹性构件1570放置于在接合构件1536中所限定的凹槽1528和由壳体1524所提供的鞍座1572之间。球形的弹性构件1570可由包括但不限于硅酮的射线可透的弹性体形成。在图4A和4B中所示的实施例中,球形的弹性构件1570可包括表面或内部特征,例如但不限于,肋、空隙、和/或可便于在球形的弹性构件1570和接合构件1536的组合的致动/压缩和松开/延伸期间实现对使用者的触觉反馈的结构。在某些实施例中,弹性构件1570可具有大致圆柱形形状、大致卵形形状、和/或可包括例如组合的球形、圆柱形、和/或卵形形状的复合形状。在某些实施例中,弹性构件1570可为中空的。
图5示出与图3A、3B和3C中所示的电极连接器类似的本发明的另一实施例。鉴于此,并且为避免冗余信息使本发明晦涩难懂,此后将仅描述ECG电极连接器1600所特有的那些特征。如在图5中所看到的,开口1634在至少一侧上由导体1677定界,开口的尺寸适于接受患者电极的按扣的头的插入。导体1677可具有任何尺寸和形状,只要导体的至少一部分沿侧壁1634的至少一部分延伸至开口1634中。在一个实施例中,导体1677延伸通过开口1634,以完全覆盖开口1634的圆周的至少一部分。导体1677可由例如导电聚合物或导电碳的射线可透的导电材料构成。由导电碳所形成的射线可透的引线(未示出)可放置于连接器壳体的通道1699中并连接至导体1677。在使用中,一旦电极按扣被放置于开口1634中并且接合构件1636被松开,接合面1637就在接合面1637和导体1677的一部分之间将电极按扣捕获。
根据本发明的一个方面,本发明的射线可透的电极连接器为有利的,因为不必在成像之前将它们从患者移除,因此减少了管理常常关键的程序所需的时间。本发明的射线可透的电极连接器还可通过减少或消除与对传统电极连接器成像相关联的危险而提高患者的安全。此外,本发明的射线可透的电极连接器可容许在成像期间对ECG患者进行监控。
应当理解的是,本发明所述领域的普通技术人员将容易地想到各种修改、替换、以及改进。这样的修改、替换、以及改进为本发明的部分,并且落入本发明的精神及范围内。可按照期望将以上所公开的更多变型以及其它特征和功能或它们的替代方案结合至其它很多不同的系统、器具和应用中。本发明所述领域的普通技术人员随后可做出目前在本文中未曾预见的或未曾预料到的各种替代方案、修改、变型或改进,其同样意欲被以下权利要求所包含。因此,前述说明和附图仅是举例说明而已。
Claims (9)
1.一种ECG连接器组件,其包括:
具有内凹面的壳体,所述内凹面具有设置于其中的开口,所述开口的尺寸适于可操作地容置ECG电极片的按扣;
设置于所述内凹面的至少一部分上的射线可透的导体;
射线可透的引线导体,所述射线可透的引线导体从所述壳体的近侧端部延伸并可操作地联接至所述射线可透的导体;
可枢转地设置于所述内凹面上并具有接合面和枢轴的接合构件,其中所述接合构件能在其中所述接合面离所述开口的顶部部分较近的第一位置和其中所述接合面离所述开口的顶部部分较远的第二位置之间枢转;
设置于所述接合面和所述接合构件的枢轴之间的弓形加强件;以及
射线可透的弹性构件,所述射线可透的弹性构件被构造成朝向所述第一位置偏置所述接合构件。
2.根据权利要求1所述的ECG连接器组件,其特征在于,所述射线可透的弹性构件包括多个叶片。
3.根据权利要求1所述的ECG连接器组件,其特征在于,所述射线可透的弹性构件包括限定于其中的中心开口。
4.根据权利要求1所述的ECG连接器组件,其特征在于,所述射线可透的弹性构件包括一个或多个突起,当使所述接合构件在第一位置和第二位置之间运动时,所述一个或多个突起协作地干涉以产生触觉反馈。
5.根据权利要求1所述的ECG连接器组件,其特征在于,所述射线可透的导体延伸至所述开口的侧壁的至少一部分上。
6.根据权利要求1所述的ECG连接器组件,其特征在于,所述射线可透的导体由碳形成。
7.根据权利要求1所述的ECG连接器组件,其特征在于,所述射线可透的导体由以下方式形成:
将导电碳粉散布于所述内凹面上面;以及
然后将所述导电碳粉熔合至所述内凹面。
8.根据权利要求1所述的ECG连接器组件,其特征在于,所述射线可透的弹性构件具有选自由大致球形、大致圆柱形、或大致卵形所组成的组的形状。
9.根据权利要求1所述的ECG连接器组件,其特征在于,所述接合构件的枢转轴线与所述内凹面的平面正交。
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- 2011-07-22 DK DK11869957.8T patent/DK2734106T3/da active
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CN103687537A (zh) | 2014-03-26 |
EP2734106A4 (en) | 2014-12-17 |
US9737226B2 (en) | 2017-08-22 |
CA2841601A1 (en) | 2013-01-31 |
US9408547B2 (en) | 2016-08-09 |
CA2841601C (en) | 2017-11-28 |
DK2734106T3 (da) | 2020-01-06 |
US20160338610A1 (en) | 2016-11-24 |
ES2762190T3 (es) | 2020-05-22 |
WO2013013370A1 (en) | 2013-01-31 |
US20140309514A1 (en) | 2014-10-16 |
EP2734106B1 (en) | 2019-09-18 |
EP2734106A1 (en) | 2014-05-28 |
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