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CN1222361C - 在医疗诊断装置中的毛细管流动控制 - Google Patents

在医疗诊断装置中的毛细管流动控制 Download PDF

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CN1222361C
CN1222361C CNB018105424A CN01810542A CN1222361C CN 1222361 C CN1222361 C CN 1222361C CN B018105424 A CNB018105424 A CN B018105424A CN 01810542 A CN01810542 A CN 01810542A CN 1222361 C CN1222361 C CN 1222361C
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R·J·沙特勒
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Abstract

测量生物流体样品中被分析物浓度的一种医疗诊断装置，包括在该装置中的毛细管流动沟道，用于将样品从入口传送到第二区。流动沟道至少在一个方向有毛细管尺寸。在流动沟道中的停止接点有边界区，边界区在那个方向有较大的尺寸和形成指向样品入口的角度。

Description

在医疗诊断装置中的毛细管流动控制
与先前申请的互相参考
这个申请与待审的1999年6月15日提交的美国09/333,793号申请有关。
技术领域
这个发明涉及医疗诊断装置，该装置包括控制流体通过该装置流动的元件；特别是，本发明涉及促进流体流动通过停止接点的装置。
背景技术
许多医疗诊断程序包括对生物流体，如血液、尿、或唾液的测试，以便确定在该流体中被分析物的浓度。这些程序测量生物流体各种各样的物理参数-机械的、光学的、电的、等等。
其中最有兴趣的被分析物是葡萄糖，在临床实验室、医生的办公室、医院、和家里测试生物流体的样品以确定葡萄糖浓度时广泛应用将干的试剂条插入到酶基的混合物中。事实上，试剂条对全国估计有1600万的糖尿病人来说，已经成为每天的必需品。因为糖尿病能引起血化学中危险的异常症状，所以它可以造成失明、肾衰竭、和其他严重的医疗后果。为了最大限度地减轻这些后果的危害，有糖尿病的绝大部分人必须周期地测试他们自己的血糖，然后相应地调整他们的葡萄糖浓度，例如，通过饮食、锻练、和/或胰岛素注射。某些病人必须测试他们的血糖浓度多至每天4次或更多。
一种类型的葡萄糖测量系统是电化学操作的，在干的试剂条上测试血糖的氧化。试剂通常包括酶，如葡萄糖氧化酶或葡萄糖脱氢酶，和氧化还原媒质，如二茂铁或氰铁酸盐。这种类型的测量系统描述在Nakamura等人的1980年9月23日颁发的美国专利4,224,125号；和Higgins等人的1985年10月8日颁发的美国专利4,545,382号中，将它们的内容插入这里作为参考。
Hodges等人在1997年5月22日出版的WO 9718464A1中公开了测量血糖的一种电化学装置，它包括两层金属化的聚对苯二甲酸乙二酯(PET)层，夹着一层涂覆粘合剂的PET中间层。金属化层构成第一和第二电极，和在粘合剂涂覆层中的切口限定一电化学单元。该单元含有与血液样品中血糖反应的试剂。该装置是细长的，从一个长侧边的入口引入样品。
在上面引用的各专利中描述的测量血糖的电化学装置，以及其他用于测量生物流体的被分析物浓度或特征的医疗诊断装置通常都需要将流体从样品入口传送到该装置的一个或几个其他部分。一般，样品流过在两个空间相隔的表面之间的毛细管沟道。许多专利，如下面讨论的，公开了医疗诊断装置和包括控制样品流量的各种方法的描述。
1981年3月3日颁发给Columbus的美国专利4,254,083号公开了一种装置，它包括通过在液滴上形成复合的弯液面，使样品入口的构造有利于促进流体样品滴进入装置的运动。(也可参看1999年12月7日颁发给Crismore等人的美国专利5,997,817号)。
1984年1月17日颁发给Columbus的美国利4,426,451号公开了一种多区流体装置，它有压力可操纵的机构用于控制各区之间的流体流动。他的装置利用有不同横截面的第一区和第二区之间界面处液体弯液面的压力平衡。当第一和第二区两个都在大气压时，表面张力产生使液体弯液面停止从第一区向第二区前进的背压。这个界面或“停止接点”的构形是这样，只有在外部产生的足够将弯液面推入到第二区内的压力加到第一区中的液体时，液体才流入到第二区中。
1989年9月19日颁发给Gibbons等人的美国专利4,868,129号公开了通过在第一区中液体上的静压，例如通过在第一区中的液柱可以克服停止接点中的背压。
1993年7月27日颁发给Shartle等人的美国专利5,230,866号公开了有多个停止接点的流体装置，其中增大在停止接点由表面张力引起的背压；例如通过捕获和压缩在第二区中的气体。在对第一区加上附加的静压之前可以排空压缩的气体，以便使流体流入到第二区中。通过改变多个平行停止接点的背压，可以形成有较低最大背压的“破裂接点”。
1995年12月5日颁发给Schembri的美国专利5,472,603号(也参看美国专利5,627,041号)公开了使用离心力克服停止接点中的背压。当流动停止时，第一区是在大气压加离心产生的压力，该压力小于克服背压所需的压力。第二区是在大气压。为了恢复流动，对第一区加上附加的离心压力，克服弯液面的背压。第二区仍然在大气压。
1999年12月14日颁发给Naka等人，在1997年10月29日出版的美国专利6,011,307号公开了一种分析样品的装置和方法，它包括通过抽吸将样品抽入到装置中，然后在分析部分使样品与试剂反应。通过光学或电化学法进行分析。在另一个实施例中，它有多个分析部分和/或旁通沟道。平衡在这些部分之间的流动而不用停止接点。
1997年12月23日颁发给Yassinzadeh等人的美国专利5,700,695号公开了一种用于收集和操作生物流体的设备，它使用“热压室”以便提供驱动力使样品移动通过设备。
1998年4月7日颁发给Yassinzadeh等人的美国专利5,736,404号公开了确定血液样品凝固时间的方法，它包括使样品的一端在通道内振动。通过交替地增加和减小样品上的压力造成振动。
上述的参考文献中没有一个建议流动通道有停止接点的装置，该停止接点在流动方向上是角形的。
发明内容
这个发明提供一种测量生物流体中被分析物浓度的医疗诊断装置。该装置包括在该装置内与样品入口流体连通的毛细管流动沟道，该流动沟道
a)适合在第一方向将生物流体的样品从靠近样品入口的第一区输送到距样品入口较远的第二区，第一区在基本垂直于第一方向的第二方向上有毛细管尺寸；和
b)有停止接点，包括边界区，该边界区
i)分离第一和第二区，
ii)在第二方向有预定的尺寸，该尺寸大于毛细管尺寸，和
iii)形成一指向第一区的角。
注意在本说明书和附图中，表示的毛细管以平行的板为界。在那种情况下，独特地确定有毛细管尺寸的“第二方向”。另一种是，本发明的毛细管可以是圆筒型的。在那种情况下，第二方向在平面圆或圆盘中是径向的，它垂直于流体的流动方向。
本发明的装置在该装置的流动沟道中装设停止接点，停止接点在流动方向是角形的。可以用很容易控制的突破压力设计这样的停止接点。
优选地，还在第二区中包括测量区域，在该测量区域内测量与流体的被分析物浓度相关的样品物理参数。
优选地，该装置包括被中间层在第二方向上分离的第一层和第二层，其中在中间层中的切口与第一层和第二层一起形成样品入口、测量区域和流动沟道。
优选地，第二区在第二方向上的尺寸基本上与毛细管尺寸相同。
优选地，边界区包括刻入到第一层的内表面中的图案。
优选地，生物流体是导电的，第一和第二层各自具有邻接中间层的导电表面，该中间层是绝缘层，并且流动沟道还包括
a)在其中一层的导电表面上的干试剂，用于与样品反应以产生可以与流体的被分析物浓度相关的电参数的变化；和
b)电化学单元，在单元内测量电参数，并且停止接点包括刻在其中一层的导电表面中的绝缘图案，从而使流过该图案的样品提供从第一区到第二区的导电路径。
优选地，还包括第二样品入口，用于将样品引入到该装置的第三区，第三区与第二区流体连通，从而使引入到第一样品入口中的流体在基本上与引入到第二样品入口中的流体相反的方向行进。
优选地，边界区形成锯齿图案，具有指向两个样品入口的角。
优选地，还包括第二样品入口，用于引入样品到该装置的第三区，第三区与第二区流体连通，从而使引入到第一样品入口中的流体在基本上与引入到第二样品入口中的流体相反的方向行进。
优选地，边界区形成锯齿图案，具有指向两个样品入口的角。
附图说明
图1描述在医疗装置中停止接点的操作。
图2-5描述在这个发明装置的一部分中流体的流动。
图6是这个发明的装置的分解透视图。
图7是图6装置的平面图。
图8是穿过图7装置的剖面图。
具体实施方式
当流体流动通过沟道时，沟道横截面的不连续处可以形成“停止接点”，使流体流动停止，如美国专利4,426,451；5,230,866；和5,912,134号所描述的那样，将它们插入这里作为参考。停止接点是由产生背压的表面张力造成，背压使流体弯液面停止前进通过不连续处。当弯液面的前向边缘遇到锐角的顶点和接着沿着该角的边被拉伸时停止接点被削弱，从而提高流量。这可以被描述为角度“指向”与流体流动方向相反的方向。
这个发明涉及医疗诊断装置，该装置有带停止接点的流动沟道。停止接点是在流动方向的角形部分，当跨过停止接点有预定的压差时它允许沟道中的流体突破停止接点。这种可控突破的停止接点的优点从如下的描述中是很清楚的。
图1说明医疗诊断条10的一部分，该条是多层的夹层结构。上层12和下层14夹住中间层16。在中间层16中的切口形成沟道18。线20和20A刻入到层12的下表面中，分别形成沟道18中的停止接点21和21A。所以，从样品入口22进入沟道18的样品S当它到达停止接点21时停止流动。
图2和3说明图1的医疗诊断条的一部分，其中通过分别加入锯齿形部分24和24A已经改进了停止接点21和21A。锯齿形部分24形成锐角A，它“指向”样品入口22。图2和3分别说明样品S在它刚好突破停止接点21之前和刚好突破之后。注意突破首先发生在指向流体流动方向相反方向的顶点。锯齿形部分提高通过毛细管沟道中停止接点的流量的效率取决于角度和构成角的边的长度。角度越小和边越长，则锯齿形部分的效率越高。因此，如果角度小和边长，那么跨过刻划区只要有很小的液压差就使样品流过该区。最好，角度A是小于约90°和它的对称轴线是与沟道中流动方向对齐。
停止接点21A有指向与入口22相反的沟道18的终端26的角度，它将会减小样品流进入终端26的阻力。如果想使停止接点能减小流体流入沟道18的任一端并流到另一端的阻力，那么最好两个停止接点21和21A有多于一个的锯齿形部分，至少每个方向有一个指向该方向的锯齿形部分(如图6和7所示)。
图4和5说明样品在它已经突破停止接点21之后通过沟道18的流动。在图4中样品停止在停止接点21A。在图5中样品在停止接点的两端已经通过停止接点21A。在那里发生突破是因为，虽然在两端的角度是大于90°，但它们小于在锯齿形部分24A中心的角度(即，指向26的角度的补角)。在样品到达在图5中所示的位置之后一段短的时间内，样品将跨过沟道18的整个宽度通过停止接点21A。
图6说明测量生物流体被分析物浓度的装置28的分解图，该装置装入本发明的毛细管流动沟道30和停止接点32和32A。上绝缘片34有导电表面36，它一般是金属，通过真空沉积、喷涂、电镀、或在先有技术中熟知的任何其他合适的提供导电表面的方法在绝缘片34的表面上覆制而成。在表面36的纵向边缘内刻有绝缘线38和38A。刻线38和38A穿过片34下面的表面36的厚度，以便提供跨过装置宽度的导电路径中的间隙。
中间绝缘层40是夹在上绝缘片34的导电表面36和下绝缘片44的导电表面42之间。中间层40最好是热塑性片，在其两个表面上有粘合剂，用于粘接到片34和44上。在中间层40中的切口沟道30在涂覆成导电的片34和44之间提供第一端46、第二端48、和在这两端之间的电化学单元50。在毛细管沟道30内，包括缓冲剂、媒质、和酶的干试剂涂层49表示在导电表面42上。另一种是，代替或除了表面42之外，试剂涂层49可以沉积在导电表面36上。电化学单元50是测量流体/试剂组合物的电参数的区域。涂覆试剂的区域通常是对应单元50，但不是必需。可以将试剂和电化学单元50限制在沟道30中的区域内和限制在刻线38和38A之间。另一种是，试剂涂层(和单元)可以延伸在装置边缘之间的整个切口区域上方。
图7是图6装置的顶视图。从图7清楚可见，刻线38和38A将导电表面36分成3个区域-36A、36B和36C-每个区域与其他两个区域绝缘。刻线38和38A的目的是允许电气监测导电生物流体样品对沟道30的充装。通过监测邻接导电区如36A、36B或36C、36B之间的电阻，人们可以确定样品什么时候桥接在各区之间的刻线38或38A。刻线38和38A构成沟道30中的停止接点和将会使流动停止，如在图1中所示，但对锯齿形部分52和52A不是这样。注意锯齿形部分52和52A形成的角度指向沟道30的第一端46和第二端48两者。所以，不象在图2-5中表示的停止接点中的“单向”锯齿形部分，在停止接点32和32A中的锯齿形部分的每个能促进样品在两个方向上的流动；即，不管样品是从第一端46还是第二端48进入。
图8是沿着图7的线8-8取的剖面图。如从图8清楚可见，刻线38和38A中断了导电表面36并伸入到绝缘片34。导电表面36一般是金，和导电表面42通常是钯，但每个可用任何其他不与试剂或样品反应并可以施加到绝缘表面的导电材料代替。使用图6、7和8的装置，有关电化学监测被分析物浓度的附加细节，在共同待审的美国申请系列号09/540，319(律师案卷号NO.LFS-93)中说明，将其插入这里作为参考。

Claims (10)

1.一种用于测量生物流体的被分析物浓度的医疗诊断装置，包括在该装置内与样品入口流体连通的毛细管流动沟道，该流动沟道
a)适合在第一方向将生物流体的样品从靠近样品入口的第一区输送到距样品入口较远的第二区，第一区在基本垂直于第一方向的第二方向上有毛细管尺寸；和
b)有停止接点，包括边界区，该边界区
i)分离第一和第二区；
ii)在第二方向有预定的尺寸，该尺寸大于毛细管尺寸；和
iii)形成一指向第一区的角。
2.如权利要求1所述的装置，还在第二区中包括测量区域，在该测量区域内测量与流体的被分析物浓度相关的样品物理参数。
3.如权利要求2所述的装置，其特征在于，该装置包括被中间层在第二方向上分离的第一层和第二层，其中在中间层中的切口与第一层和第二层一起形成样品入口、测量区域和流动沟道。
4.如权利要求3所述的装置，其特征在于，第二区在第二方向上的尺寸基本上与毛细管尺寸相同。
5.如权利要求4所述的装置，其特征在于，边界区包括刻入到第一层的内表面中的图案。
6.如权利要求3所述的装置，其特征在于，生物流体是导电的，第一和第二层各自具有邻接中间层的导电表面，该中间层是绝缘层，并且流动沟道还包括
a)在其中一层的导电表面上的干试剂，用于与样品反应以产生可以与流体的被分析物浓度相关的电参数的变化；和
b)电化学单元，在单元内测量电参数，并且停止接点包括刻在其中一层的导电表面中的绝缘图案，从而使流过该图案的样品提供从第一区到第二区的导电路径。
7.如权利要求1所述的装置，还包括第二样品入口，用于将样品引入到该装置的第三区，第三区与第二区流体连通，从而使引入到第一样品入口中的流体在基本上与引入到第二样品入口中的流体相反的方向行进。
8.如权利要求7所述的装置，其特征在于，边界区形成锯齿图案，具有指向两个样品入口的角。
9.如权利要求6所述的装置，还包括第二样品入口，用于引入样品到该装置的第三区，第三区与第二区流体连通，从而使引入到第一样品入口中的流体在基本上与引入到第二样品入口中的流体相反的方向行进。
10.如权利要求9所述的装置，其特征在于，边界区形成锯齿图案，具有指向两个样品入口的角。
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DK1268063T3 (da) 2005-10-17
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RU2237426C2 (ru) 2004-10-10
DE60112414T2 (de) 2006-03-30
MXPA02009664A (es) 2003-10-14
IL151915A0 (en) 2003-04-10
PT1268063E (pt) 2005-10-31
TW496960B (en) 2002-08-01
HK1049458B (zh) 2006-01-20
US6488827B1 (en) 2002-12-03
KR20020092402A (ko) 2002-12-11
AR028908A1 (es) 2003-05-28
AU2001249430A1 (en) 2001-10-15
CN1431934A (zh) 2003-07-23
RU2002125862A (ru) 2004-03-10
ES2247090T3 (es) 2006-03-01
EP1268063A2 (en) 2003-01-02
MY133802A (en) 2007-11-30
EP1268063B1 (en) 2005-08-03
DE60112414D1 (de) 2005-09-08
ATE301001T1 (de) 2005-08-15
JP2003529089A (ja) 2003-09-30
WO2001074242A2 (en) 2001-10-11
WO2001074242A3 (en) 2002-02-28
HK1049458A1 (zh) 2003-05-16

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