CN101688864A - 具有激光密封的毛细管空间的生物传感器及其制备方法 - Google Patents

具有激光密封的毛细管空间的生物传感器及其制备方法 Download PDF

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Publication number
CN101688864A
CN101688864A CN200880023246A CN200880023246A CN101688864A CN 101688864 A CN101688864 A CN 101688864A CN 200880023246 A CN200880023246 A CN 200880023246A CN 200880023246 A CN200880023246 A CN 200880023246A CN 101688864 A CN101688864 A CN 101688864A
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China
Prior art keywords
laser
overlayer
substrate
biology sensor
sample
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CN200880023246A
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R·S·布拉
A·拉兹班
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F Hoffmann La Roche AG
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F Hoffmann La Roche AG
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    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
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Abstract

测试条或生物传感器，包括在其上形成电极系统的基底。一个或多个层压层覆盖在所述基底之上，以形成其中沉积有试剂的样品接受腔。提供从所述样品接受腔到所述生物传感器外部的开口。将所述层和所述基底激光焊接以固定所述生物传感器。所述层和基底中的一个是可透光的，以允许在两者之间的界面处进行激光焊接。所述生物传感器可以由一系列连续卷幅形成，然后将其切片以形成单一的生物传感器。

Description

具有激光密封的毛细管空间的生物传感器及其制备方法
本发明总的涉及对体液的分析物浓度的测试，更特别地涉及用于该测试的测试条(test strip)或生物传感器。
测试条通常用于测定测试样品中选定分析物的存在和/或浓度。例如，使用多个测试条来测试血液中的葡萄糖浓度，以检测具有糖尿病的人们的血糖水平。这些测试条包括已经将试剂组合物沉积在其中的反应腔(reaction chamber)。测试条的目前趋势要求更小的测试样品和更快的分析时间。这为患者提供了显著的益处，使得可以使用能够来自身体的更少敏感区域的更少的血样。此外，更快的测试时间和更精确的结果能使患者更好地控制其血糖水平。
在更小的样品体积方面，已知提供具有充分小的反应腔以使得通过毛细作用将其中的流体抽出的测试条，这是由于样品流体的表面张力和液体使其表面积最小化的热动力学趋势导致的现象。例如，美国专利号5141868公开了具有其尺寸充分小足以通过毛细作用将其中的样品流体抽出的空腔的测试条。该空腔被两个平行板限定，其被两个沿该板的侧面纵向延伸的环氧条间隔开约1mm。该空腔两端敞开，一端接收样品，另一端允许空气逸出。该空腔包括电极结构，并负载有适于用该测试条进行该测试的材料的涂层。
多种其他测试条设计包括将其中的样品流体抽出的毛细管空腔并包括允许空气逸出的排气口。正如人们应当认识到的那样，目前的测试条设计中的毛细管通道典型地非常小，并不断的设计得更小以减少测试所需的样品量。然而，毛细管入口宽度越小，将小体积样品精确应用(或“靶向(target)”)到该测试条的毛细管中就越难。在具有损伤的视力和/或降低的灵敏度的人口部分中导向甚至是更重要的，因为这部分人将其手指精确对准测试条的定量配送边缘是困难的。而且，样品流体有时会在抽入该毛细管中之前不适当地中断，这是称作“定量配送中断”的现象。将会需要克服与测试条中小毛细管相关的该困难。
测量血液中化学物质浓度的电化学方法的局限性是在将分析物和试剂的多种活性组分的扩散方面的变量相混淆的影响。对血糖测量精确度的局限性的实例包括血液组成或状态的变化(非测量方面)。例如，血细胞比容(红细胞的浓度)的变化能够影响血样的信号产生。在其中该结果并不补偿其他样品变量或干扰(例如血细胞比容和温度)的应用中，使用在短测试时间之后报道的血糖响应值是有问题的。
关于血样中的血细胞比容，现有技术的方法依赖于使用玻璃纤维过滤器或用包含例如仅能使血浆进入该膜的成孔剂的试剂膜从样品的血浆中将红细胞分离出来。用玻璃纤维过滤器分离红细胞提高了该测量所需的血样量，这与用户期望的测试用量是相反的。多孔膜(film)或薄膜(membrane)在降低血细胞比容影响方面仅是部分有效的，而且必须和增高的延迟时间和/或特定的测量技术相结合使用，以实现所需的精确度。因此，需要制造能够以容易、简单和成本有效的方式降低血细胞比容的干扰。
通常使用粘合剂将测试条的多个层结合或密封在一起。对于测试条的高容积制备，作为原料以及特别与制造成本相关，粘合剂能够是重要的成本。例如，粘合剂能够不利地影响几种制造方法。作为实例，由于粘合剂碎末(sawdust)的累积，用于切成网并形成条的切割机能够随时间粘搭。因此该切割机必须周期性停机用于清洁。这种周期性的制造中断导致较低的制造速度。因此，需要以廉价方式制造测试条。
本发明的第一方面涉及包括基底(base substrate)和至少一个覆盖在该基底之上的覆盖层的生物传感器。该基底和该覆盖层共同限定了在两者之间的样品接受腔。试剂位于该样品接受腔内。该基底和该覆盖层进一步共同提供了沿该生物传感器边缘的用于该样品接受腔的开口。该基底和该覆盖层是激光焊接的，以限定该样品接受腔。
另一方面涉及包括基底和覆盖层的生物传感器。一个或多个激光焊接处与该基底和该覆盖层共同限定了其尺寸以降低血样中的血细胞比容干扰的微毛细管腔。试剂位于该微毛细管腔内，用以分析该血样。
另一方面涉及包括位于基底和覆盖层之间的用于进一步限定样品接受腔的间隔件(spacer)的生物传感器。该间隔件和基底是激光焊接的，且该覆盖层和该间隔件也是同时或顺序激光焊接的。试剂位于该样品接受腔内。
另一方面涉及其中将试剂沉积在基底上的方法。将该基底和覆盖层以及非必要的间隔层激光焊接在一起以形成包含该试剂的生物传感器的样品接受腔。
为更好地理解本发明、其优点以及由其实现的目的，应当参考附图以及伴随的说明，其中解释和描述了本发明的优选实施方案。
现在参考附图，其中在整个几种视图中，类似的参考数值和字母表示相应的结构。
图1是依照一种实施方案的使用激光焊接的生物传感器制造技术的流程图。
图2是依照图1中所示的技术组装的生物传感器卷幅(web)的分解图。
图3是依照图1中所示的技术激光焊接的第一生物传感器的放大图。
图4是依照图1中所示的技术激光焊接的第二生物传感器的放大图。
图5A是依照另一实施方案的使用激光焊接的生物传感器制造技术的流程图。
图5B是依照另一实施方案的使用激光焊接的生物传感器制造技术的流程图。
图5C是依照另一实施方案的使用激光焊接的生物传感器制造技术的流程图。
图6是显示应用于基底材料卷幅中的间隔层的分解图。
图7A是双层压生物传感器。
图7B是用于三层压生物传感器的激光焊接系统的简图。
图8是用于图7的激光焊接系统中的辊筒(drum)组合件(assembly)的横截面视图。
图9是图8中的辊筒组合件的透视图。
图10是图7中的激光焊接系统的变型的前视图。
图11是图10中的激光焊接系统的放大透视图。
图12是第一种三层压生物传感器的顶视图。
图13是第二种三层压生物传感器的顶视图。
图14是图12中的第一种三层压生物传感器的分解图。
图15是一卷基底卷幅的透视图。
图16是图15中的基底卷幅的放大图。
图17是一卷间隔卷幅的透视图。
图18是图17中的间隔卷幅的放大图。
图19是一卷覆盖层卷幅的透视图。
图20是图19中的覆盖层卷幅的放大图。
图21是包括在组装过程中覆盖在图15的基底卷幅之上的图17的间隔卷幅的层压物的顶视图。
图22是在组装过程中覆盖在图21的层压物之上的图19的覆盖层卷幅的顶视图。
图23是显示激光焊接区域的图22的层压物的顶视图。
图24是由图23的层压物制成的生物传感器卷幅的顶视图。
图25是第三种三层压生物传感器的分解图。
图26是显示其激光焊接区域的该第三种三层压生物传感器的顶视图。
为了促进对本发明的原理的理解，现在将参考此处所述的特别实施方案，将使用特定的语言来描述这些实施方案。然而将认识到由此不意于限制本发明的范围。在所述的方法或装置中的任何改变和其他改进，以及对此处所述的本发明的原理的其他应用，都是本发明所属领域技术人员通常会进行的预期。
生物传感器及其制备方法是普通公知的。更特别地，适用于本发明的生物传感器及其制备方法可获知于US 2005/0019212A1(公开于2005年1约27日)。特别参照该公开的美国专利申请的第[0048]-[0249]段和附图1～19C，其中详细公开了通常适用于本发明的生物传感器和方法。
尽管US 2005/0019212A1中公开的生物传感器和方法以电化学实施方案的特别重点进行描述，但本发明并不限定于电化学系统、传感器和方法。而且本发明的方法和生物传感器也能够与本领域通常已知的光学传感器技术结合使用。
激光密封的制造技术
如上述背景技术部分描述的那样，用于测试条的高容积制备的粘合剂在作为原料和特别关于制造成本的两方面都可能具有显著的成本。下面将描述不使用粘合剂的多种技术，其中将测试条的层压结构激光焊接在一起。能够用这些激光焊接技术以有效和成本效率合算的方式制备测试条。例如，能够显著降低或甚至一起消除了与粘合剂相关的材料成本。另外，通过使用粘合剂产生的制造问题能够得到减弱或消除。如前所述，当使用粘合剂将该测试条的多个层和组件(component)粘合在一起时，粘合剂碎末可能结胶在用于切割该测试条的切割机上。因此，该切割机需要周期性地停机用于常规清洁和维护，由此降低了制造速率。使用此处描述的激光焊接技术，能够显著降低或甚至消除与粘合剂相关的该问题。尽管该技术的讨论重点将是通过激光焊接形成毛细管通道，但应当认识到能够通过激光焊接通过将测试条的其他组件结合在一起。例如，如下面将描述的那样，能够将该测试条的所有层都激光焊接在一起，由此消除对粘合剂的需求。例如通过在该层压结构的大多数或所有表面上使用激光作用或用在其上的点焊能够实现该不含粘合剂的测试条。
对于本发明目的，将两个层压层激光焊接在一起的内在原理是对于任何给定类型的激光，都有将不吸收激光能量(作为结果，通过其中)的清澈(或透明)材料和将吸收该能量的黑色(或吸收性)材料。如下面将更详细解释的那样，重要的是注意该术语“透明”和“黑色”是指该材料的激光能量吸收特征，并不必须表示是半透明、不透明或其颜色。需要这些相邻的透明的和黑色材料基本具有相同的化学以及物理性质(例如相同或接近相同的聚合物基质，相同或接近相同的熔点)。为了将两层密封在一起，将该激光引到双层压设置的透明层上。激光的能量通过该透明层，并由黑色层吸收。然后该黑色层熔化，来自该物理反应的热量又熔化该透明层。然后该熔化的部分混合并冷却，留下焊接处。如果该透明和黑色层的化学和/或物理性质显著不同，该混合可能不是耐用的，由此留下弱的或者不充分的焊接。
该层的焊接通常不在各层的整个厚度上发生。即，对于给定的激光能量，该黑色层通常仅焊接到其中特定的深度。然而，能够按顺序或同时将多于两个层激光焊接在一起。作为实例，可以将三个层激光焊接在一起，以产生三层压结构。对于三层压设置，能够将激光单独引到外层，根据该激光装置的构造和该层压物的卷幅，其能够是同时或按顺序进行的。例如，能够将第一透明层激光焊接到中间黑色层的第一侧，然后将该结构翻转用于将第二透明面焊接到该中间黑色层的第二侧。可替代地，可以在该结构的通常两个对侧上使用两份激光以同时(或接近同时)将第一和第二透明层激光焊接到该黑色层上。作为结果，在三层压设置中，两个外层通常都是透明的，而该中间层是黑色的。
尽管前述，但只要该层的厚度足够薄或激光能量足够高，可使该黑色层在其整个厚度上熔化，以同时在相对侧上焊接到该透明层上。在这种情况下，在对准焊接到黑色中间层上的透明外层发射的单一激光中可以制备三层压条，该黑色中间层又焊接到在相对于激光的黑色侧上的黑色或透明外层上。
如背景技术部分中还提及的那样，血细胞比容水平的变化能够影响血样的产生信号，因此需要制备能够以容易、简单和成本效率方式减少血细胞比容干扰的生物传感器。已经发现通过微毛细管的物理分离显著降低血细胞比容。该微毛细管还降低了所需的样品体积，这是使用者所需的。然而，由于微毛细管涉及的小尺寸，需要在制备过程中紧密控制尺寸。发现能够通过激光焊接制备具有高通量、低成本和紧密容差控制的微毛细管。使用激光焊接，能够以有效的、一致性的和成本有效的方式制备具有20nl～200nl(或甚至更小)的体积的微毛细管。用这种技术制备的该微毛细管消除了对通过使用试剂作为亲水改性剂的昂贵的经表面处理箔的需求。通常，当在该测试条中使用双层压结构时，产生了这些用于分离血细胞比容的微毛细管。
原理是红细胞较大，因此如果通过将在该激光作用序列过程中松散保持在一起的两个层密封在一起形成毛细管，毛细管的高度足够高以能使流体通过毛细管作用进入，但其高度过低以不能使红细胞进入。因此，红细胞聚集在该微毛细管通道的入口处。为了进一步便于定量配送(dosing)到这种微毛细管通道中，能够制备该顶层的凹入切口，使得该条的接触与顶部定量配送的条类似，但反应位置在该毛细管通道内。
图1中的流程图600描述了依照一种实施方案的激光焊接技术的一种实施例，能够将其加入到参照US 2005/0019212A1的图5～19所述的生物传感器制备技术中。应当认识到，除参照US 2005/0019212A1的图5～19所述的那种之外，还能够将该激光焊接技术加入到其他生物传感器制备工艺中。例如，应当认识到该激光焊接技术不应当限于此处所述的特定的实施方案，例如烧蚀电极、冲模(slot die)涂覆试剂层等。即，该激光焊接技术能够适用于其他类型的测试条，例如具有印刷电极、分散的试剂、通风孔等的那些。一般来讲，不使用粘合剂，在所示的技术中使用激光焊接将该腔室覆盖层240(参见US2005/0019212A1的图12)固定到该生物传感器的剩余部分上。该技术能够用于通过连续和/或间歇制备方法制备测试条。例如，能够用该技术通过连续卷幅工艺大量制备大体积的生物传感器。可替代地，通过此处所述的激光焊接技术能够制备个体测试条。
在阶段602中，以上述方式形成电极182、迹线(traces)184和接触垫186的组(参见US 2005/0019212A1的图7)。在一个实施例中，将金或其他贵金属溅射或气相沉积在形成基底12的薄的透明电极支撑箔的一个侧面上。在选定实施方案中，该支撑箔能够为约200μm厚，且该支撑箔能够例如是透明聚碳酸酯(PC)或聚酯(PET)箔。为了帮助下面将详细描述的该激光焊接工艺，该支撑箔能够相对于激光焊接中所用的辐射类型是清澈或透明的，但如应当认识到的那样，在其他实施方案中该箔也能够是不透明或半透明的。对该新镀金属的表面或膜170进行激光烧蚀以形成电极182、迹线184和接触垫186以及其他特征，如US 2005/0019212A1的图7中所示。再次，应当认识到该电极182能够通过其他技术制备。
如前所述，该试剂层190能够配制得使其是亲水的，由此消除对昂贵的经表面处理的覆盖箔的需求。在阶段604(图1)过程中，沉积该试剂层190(如果需要，并将其干燥)。例如，能够使用电磁波纹管(electromagnetic bellow，EMB)技术，其可以将试剂以高精度仅沉积到需要的位置。EMB分配产品在市场上可获自Fluilogic OY，Espoo，Finland。类似地，在其他实施方案中，能够使用激光打印、喷墨打印、激光喷墨打印或甚至激光烧蚀技术，例如Home Diagnostics，Inc.的WO 2007/033079A2中所述的那些。该用于激光焊接的试剂层190通常用一个或多个单独的离散部分中断。例如，在图2中所示的实施方案中，试剂层190能够是沉积在该电极182上的离散试剂垫或部分的形式。在试剂垫190之间，存在不被该试剂覆盖的未覆盖部分605。这些未覆盖部分605在该基底卷幅188和该腔室覆盖层或卷幅240之间提供了透明的接触表面，用于促进层之间进行的激光焊接。在焊接位置的透明层和黑色层之间存在的任何试剂都可能容易遮蔽或堵塞激光能量在吸收性或黑色层上的吸收。这又能容易弱化在层之间所得到的焊接和/或阻止层之间的适当密封。上述电磁波纹管技术是一种适用于产生这些离散的试剂垫190和未覆盖部分605的实施方案，由此使该试剂通过污染弱化该焊接的风险最小化。预期痕量的试剂190能够存在于部分605处到最小的程度以使不会显著影响焊接强度和激光焊接的密封度。还预期了能够以也促进激光焊接的方式对部分605进行着色和/或处理。例如，能够对部分605进行着色以吸收激光能量以促进激光焊接，或者部分605能够是透明的以使该激光能量能够穿过其通行以加热其他表面，例如该腔室覆盖层204。本领域普通技术人员将认识到该基底卷幅188或覆盖层240哪个分别是该透明层和黑色层只是设计选择的问题，后附权利要求关于哪个结构元件是透明的还是黑色的都不将是限制性的(除非特别指出)。在这一点上，任何特别参考或说明都仅用于举例目的。
如图2的分解图中能够看到的那样，已经消除了该间隔层(参见US 2005/0019212A1的附图10中的196)。取而代之的是，该腔室覆盖层(第二层)240直接附着在该基底卷幅(第一层)188上。通常地，该腔室覆盖层240是平坦的，并形成样品接受(微毛细管)腔24，在某些实施方案中，该腔室覆盖层240可以在阶段606中被压纹(emboss)以形成通道凹槽607。该通道凹槽607间隔设置以与用于个体试剂条的电极182和试剂190相一致。应当认识到该通道凹槽607能够以除通过压纹之外的其他方式形成，例如通过使该腔室覆盖层240拉伸、折叠或变形。而且，该通道凹槽607能够在产生该腔室覆盖层240的过程中产生，以使得该通道凹槽607与该腔室覆盖层240整合。进一步预期能够通过将另外的组件(例如额外的层)施加到该腔室覆盖层240上来形成通道凹槽607。
在其他实施方案中的阶段606能够是非必要的，使得该通道凹槽607也是不需要的。例如，没有通道凹槽607的腔室覆盖层240能够以使得在该覆盖层240和基底188之间可以有形成样品接受腔24的小缝隙的方式，有些松散地附着于基底材料188上。将该两层激光焊接在一起，没有间隔件，也没有压纹在该覆盖物上的通道。相反，将层通常松散地结合在一起并激光密封。这可以形成非常细的毛细管通道，其能够用于血细胞比容的分离。如前所述，红细胞是较大的，因此如果在激光焊接过程中通过将松散地保持在一起的两层密封在一起形成毛细管，那么该毛细管的高度足够高可使流体通过毛细作用进入其中，但过低以不能使红细胞进入。因此，红细胞在该毛细管通道的入口处聚集。在一种形式中，在附着期间该腔室覆盖层240松弛，以产生相对大的样品接受通道24，但在其他形式中，该腔室覆盖层240能够张紧以使样品接受通道24相对薄，从而使样品尺寸最小化以及提高血细胞比容的分离。应当认识到阶段606能够以于图1中所示不同的顺序发生。例如，阶段606能够发生在阶段602和604之前、期间和/或两者之间。
在阶段608中，将腔室覆盖层240激光焊接到该基底材料的卷幅188上。如前所述，激光焊接能够产生具有高量、低成本和具有紧密容差控制的微毛细管。由于其小尺寸，微毛细管又能降低血细胞比容干扰。
如应当认识到的那样，制备任何相干态的颗粒或电磁辐射的装置被认为是激光器。在大多数情况下，“激光器”是指相干光子源，即灯或其他电磁辐射。如应当认识到的那样，在首字母缩写词LightAmplification by Stimulated Emission of Radiation(laser，激光)中的术语“light，光”通常用于广义含义，为任何能量的光子；其并不限定于在可见光谱中的光子。因此，有X射线激光、红外激光、紫外激光等。例如，通常将与光学激光等效的微波称作“微波激射器”，但应当认识到为了此处的讨论，微波激射器也被认为是激光器的一种。尽管该技术将参考光学或近光学类型的激光器进行描述，但应当认识到能够使用其他类型的激光器将多个层焊接在一起。在一种特别形式中，用于激光焊接的激光器是红外的(IR)固态激光器。在阶段608中进行激光焊接的激光器能够是连续式激光器或脉冲式激光器。在一种实施方案中，该激光焊接机器是在市场上可获自Leister ProcessTechnologies，Sarnen，Switzerland的类型，但当然能够使用其他类型的激光焊接机。
当在讨论激光焊接过程中参考该多个层的光学性质时，该光学性质是关于所用的激光类型的。例如，当某层在光学光中是透明的(或甚至半透明的)但在紫外光中是吸收性的时，当使用紫外激光时该层将被称作是“吸收性的”(或黑色的)，但当光学激光时其是透明的。为了帮助读者理解该技术，此处可以使用词语“黑色”以表示激光吸收层，甚至在当被人们观看时该层事实上并不是真实黑色时，但例如，其可以是其他颜色或色调，例如灰色、棕色等。以相似的方式，术语“透明”有时在此处可用于表示关于该激光束是透明的或半透明的激光透射层，以使得该激光束(至少部分)能够通过该层。总的来讲，在多个层的激光焊接过程中，该层中的一个是相当于其他层中的至少一个来说对该激光束是更能透射的，以及相当于其他层中的至少一个来说是更吸收激光能量的。这与某些已知的激光焊接技术是有区别的，在该已知的激光焊接技术中，该层能够是任何材料，其中一层是透射的，以及另一层首先涂覆有设计以吸收激光能量并将各层粘合或焊接在一起的物质。商品实例是由Gentex Corporation of Simpson，Pennsylvania提供的
Figure G2008800232463D00101
工艺。然而，在本设计中，不需要在任何层上涂覆物质，在大多数实施方案中，其通常是用于避免的材料和制备成本。
当某层比其他层更具吸收性时，例如当对于光学类型的激光，某层是黑色的且其他层是透明的时，激光束通过该透射性的(透明)层并被该吸收性的(黑色)层吸收。由激光束的吸收产生所得到的热将使该吸收层全部或部分熔化。然后该吸收层的热使该透明层熔化。然后熔化的部分混合并冷却，留下焊接处。如前所述，如果该透明的和吸收性的层具有显著不同的化学和/或物理性质，那么该混合可能不是耐用的，由此留下弱的或者不充分的焊接。
能够以多种方式将该腔室覆盖层240激光焊接到该试剂覆盖层188上。查看图3，该腔室覆盖层240与覆盖该电极182和迹线184的通风元件610间隔设置，以产生通风开口34。如其所示，沿该测试条614端部圆周以及沿样品接受腔24的焊线612焊接该腔室覆盖层240。如前，能够沿裁边(trim)线262修剪该测试条614的端部，能够沿分离线264分离个体测试条614。在修剪之后，该焊线612至少部分保持附着在该测试条上，以防止体液在取样过程中绕过该样品接受腔24。
在焊接过程中，激光能量照射通过透明(或半透明/透射性的)层，并被相对于所用激光束具有吸收性的层吸收，以产生熔化全部或部分该层并由此产生焊线612的热量。在一种实施方案中，相对于用于焊接的激光能量，该覆盖层240通常是吸收性的，而该基底卷幅188通常是透明的。该覆盖层240在一个特别实施例中是黑色的(0.5％碳黑)，该卷幅188是透明的。尽管该覆盖层240通常吸收该激光的能量，但在一些形式中如果使用不可见光激光束，该覆盖层240能够在视觉上是透明的。当该覆盖层240是光学透明的(或半透明的/半透明的)时，该覆盖层240能够形成用于确定填充充足的可视化窗口。在这种实施方案中，该激光束施加到卷幅侧188。在施加光束时，该光束照射通过该基底卷幅188，以及不透明的覆盖层240吸收该激光束能量。由激光束能量的吸收产生的热量使该覆盖层240和该卷幅188熔化。一旦冷却，该覆盖层240和该卷幅188沿焊线612熔合在一起以产生坚固的流体密封性的密封。如上所述，在一种实施方案中，沿该焊线612的通道凹槽607帮助限定该样品接受腔24，但在其他实施方案中，预期该通道凹槽607能够是非必要的。
在可替代的实施方案中，该覆盖层240通常是透明的(透射性的)，该基底卷幅188通常是吸收性的(黑色的)。在该实施方案中，激光束施加穿过该透明的覆盖层240，并被吸收性卷幅188吸收。被卷幅188吸收的能量使该卷幅188和覆盖层240熔化并在焊线612处熔合在一起。当该覆盖层240在可见光中是透明的时，该覆盖层240能够用于形成可视化窗口。
使用前述实施方案，将该激光束施加到单一侧，但在其他实施方案中能够同时或连续将该激光束施加到两侧。例如，覆盖层240和基底卷幅188都能是黑色的，激光束同时以通常相对的方式施加到覆盖层240和卷幅188上。而且，该多个层不需要具有均匀的吸收性或透明性。换言之，在某层上的多个位置处该透射性质能够是不同的。作为一种实例，使意于被焊接的层的一部分是吸收性的，而使其他部分是反射性的或经构造以散射光，从而抑制在不应当焊接的区域内的焊接，例如在样品接受腔24内。应当认识到能够使该多种层整体或部分临时性或永久性地吸收激光能量，例如通过将不透明油墨施加到一个或多个层上。可以预见到能够将图形标记印刷到或涂覆到该覆盖层240以及其他组件上。在激光焊接过程中也能够使用多种掩模技术以防止或促进多个区域中的激光焊接。
如果需要，能够通过激光焊接结合其他组件。例如，能够通过激光焊接结合通风元件610。而且，能够在将覆盖层240激光焊接到该卷幅188上之前、期间或之后结合该通风元件610。激光焊接能够和其他用于固定多个层的形式结合使用。例如，在用激光焊接永久固定某层之前，能够使用粘合剂临时性地固定该层。一旦组装好，将该测试条或传感器614以如上所述的方式单独冲压和包装。可替代地，该传感器614能够保持结合在一起，以产生用于多重试验仪盒(cartridge)的传感器带。与前述实施方案类似，以使该样品接受腔24沿测试条614的端部边缘开启用于端部定量配送目的的方式冲压或切割该传感器614。
图4显示了可替代的实施方案，其中将覆盖层或箔616从该样品接受腔24拉伸到接近接触垫186，以覆盖该电极182和迹线184。与前述实施方案类似，将该覆盖层616激光焊接到基底卷幅层188上以产生两层或双层压设计。该卷幅188和覆盖层616可以以如上所述的方式着色。即，该层能够可替代地是透明的和吸收性的，使得该层之一允许激光束通过，而另一层吸收该激光束。不使用具有图3中所示类型的焊线612，图4中的覆盖层616具有限定出所述样品接受腔24的焊接区域618。能够将用于排放来自样品接受腔24的空气的通风开口620冲压或成型在该覆盖层616中。非必要地，能够将上述类型的主体盖234(参见US 2005/0019212A1的图12)附着在覆盖层616上，以部分覆盖通风开口，由此提供填充指示线。一旦组装好，能够将个体传感器622分开并包装，用于单独用途，或者该传感器622能够保持结合在传感器带上用于多重测试仪盒。
应当认识到激光焊接也能够用于三个(或更多个)层的传感器构造中，类似US 2005/0019212A1的图10～13中所示的那种。不使用粘合剂，而是通过激光焊接将基底卷幅188、间隔层196和覆盖层240固定在一起。也能够将其他元件(例如主体盖234)激光焊接在适当的位置。图5A中的流程图624描述了用于将三个层激光焊接在一起以形成三层压结构的技术。在阶段626中，以例如上述的方式形成电极、迹线和接触垫的组(参见US 2005/0019212A1的图7中的182、184、186)。在一种实施例中，将金沉积在形成基底(电极支撑基材(substrate))的薄的透明电极支撑箔的一个侧面上。在选定实施方案中的该支撑箔能够为约200μm厚，且该支撑箔能够例如是透明聚碳酸酯(PC)或聚酯(PET)箔。对该新镀金属的表面或膜进行激光烧蚀以形成电极、迹线和接触垫以及其他特征，如US 2005/0019212A1的图7中所示(参见编号170、182、184、186)。应当认识到所述电极图形能够以其他方式形成，例如通过印刷技术等。
在阶段628中，将该试剂层(参见US 2005/0019212A1的图8中的190)以上述任何适合的方式用足够的精度和清晰度沉积在卷幅上的电极上，以避免在基底和间隔层之间在意于激光焊接的任何位置处留下任何超过痕量的试剂。在一种实施方案中，在试剂垫之间，存在未被试剂覆盖的未覆盖部分605。如应当认识到的那样，也能够以其他方式沉积该试剂层190。
转向图6，在阶段630中，将具有预毛细管220a、220b、220c等的间隔(第二)层196施加到基底材料的卷幅188上，并将这些层激光焊接。在一种实施方案中，该间隔层196是约100μm厚的PC或PET箔，但应当认识到在其他实施方案中，该覆盖层240能够具有不同的厚度和/或由不同种类的材料制成。然而，甚至在这种情况下，该多个层通常具有相似的化学和物理性质以确保足够的焊接强度也是有帮助的。在一种实施例中，该间隔层196具有足够高以使流体能够借助于毛细作用进入但足够低以使红细胞不能进入由此提高血细胞比容分离的厚度。
在阶段632中，将覆盖层240和主体盖234一起应用到由间隔层196和卷幅188形成的组合件230中，如US 2005/0019212A1的图12中所示的那样，并将其激光焊接。在一种实施方案中，该覆盖层240是约100μm厚的PC或PET箔。然而，应当认识到该覆盖层240能够具有不同的厚度和/或由不同材料制成。一旦将该三层激光焊接在一起，其产生组合件260，在US 2005/0019212A1的图13中所示。在一种实施方案中，该基底材料卷幅188和覆盖层240通常是清澈的或透明的，该间隔层196通常是黑色的(0.5％wt/wt)。
为了避免在基底卷幅188上仅在待限定的毛细管通道的尺寸内沉积试剂层190中的特别严格的容差，在一种实施方案中(参见图5B中的流程图)，在沉积试剂层190之前，将该间隔层196施加到该基底卷幅188(在其上已经形成了电极图案)上并激光焊接在一起。然后将覆盖层240施加到该间隔层196上并激光焊接在一起，以产生组合件260。因此，阶段的顺序是626、630、628、632。对于该顺序的一种可能的连续工艺实施方案的示意图，参见图7B。
在依照图5A和5B的激光焊接过程中，将激光束以按顺序的方式施加到该卷幅188和覆盖层240上以将各层激光焊接在一起。然而，在其他实施方案中，能够通常同时将该三个层激光焊接(例如参见图5C)。因此，在阶段630a和632a中，将该间隔层196施加到基底卷幅188(在其上已经以充分精确和限定的图案分布有形成的电极图案和试剂层)上，并将覆盖层240施加到该间隔层196上。在阶段634中，通常同时将该三个层激光焊接在一起。如上所述，这样能够以至少两种不同的方式实现。首先，作为将激光束以通常相对的关系应用于两侧的结果，可以将已经集合在一起的三个层激光焊接。其次，通过经构造以将该三个层一次性焊接在一起的单一激光可以激光焊接已经集合在一起的该三个层，其中该间隔层196包括更具吸收性或黑色的层，该覆盖层240和基底卷幅188中的一个或另一个包括透射性或透明层，其中该层240和卷幅188的另一个可以是透明的或黑色的。
在前述实施例中，该卷幅188和覆盖层240是透明的，该间隔层196是吸收性的或黑色的。然而，能够使用其他颜色组合。作为实例，该卷幅188能够是与通常能够是透明的或更透射性的间隔层196和覆盖层240相比是黑色的或更具吸收性的。在阶段630中在将该间隔层196施加到该卷幅188上之后，将该间隔层196激光焊接到该卷幅188上。一旦焊接了该间隔层196，能使该间隔层196更不具透射性，例如通过将深色油墨印刷在该间隔层196上或暗化该间隔层196，以促进该覆盖层240的激光焊接。然后将相对透明的覆盖层240激光焊接到新暗化的间隔层196上。
能够使用多种系统来进行上述激光焊接技术。现在将首先参照图7A描述用于形成双层压生物传感器的激光焊接系统640的实例，其显示了激光焊接系统640的示意图。图7B显示了下面将更详细描述的用于形成三层压生物传感器的激光焊接系统的示意图。如能够看到的那样，图7A中的激光焊接系统640包括供给形成腔室覆盖层240的覆盖层卷幅644的覆盖供带盘(supply reel)642和供给形成电极支撑基底卷幅层188的基底卷幅648的基底供带盘646。在所示的实施方案中，该覆盖层卷幅644通常是黑色的或激光吸收性层，该基底卷幅648通常是透明的或激光透射性层。然而，应当认识到这些卷幅的性质可以相反。即，该覆盖层卷幅644能够通常是透明的，且该基底卷幅648在其他实施方案中能够是黑色的。在这种情况下应当认识到该卷幅相对于激光的位置需要交换，以使得激光能够被黑色卷幅所吸收。在所示的实施方案中，该覆盖层卷幅644不包括任何类型的压纹，以使得形成的毛细管通道非常细，以促进血细胞比容分离，但在其他实施方案中，该覆盖层卷幅644能够包括压纹。在所示的实施方案中的基底卷幅648包括电极和沉积的试剂。沿各卷幅644、648，供应制动器或伺服传动装置650控制该卷幅644、648的张力和/或速度，以使其对于该激光焊接工艺保持适当的同步。如果使用伺服传动装置代替制动器来控制位置650处的带盘642、646的退绕速度，则对于输入和输出卷幅通常都将需要张力传感器。在系统640中使用线性卷幅导向装置652来引导该卷幅644、648。
在激光焊接部分654处将两个卷幅644、648激光焊接在一起。如图7A中能够看到的那样，该激光焊接部分654包括压辊656和辊筒组合件658。图8显示了辊筒组合件658的实施方案的横截面视图，图9显示了透视图。参照图8，该辊筒组合件658通常包括伺服电动机660、弹性联轴节(coupling)662、掩模心轴664、轴承间隔件666、掩模轮668和丙烯酸类轮670。该伺服电动机660通过弹性联轴节662连接掩模心轴664。与该伺服电动机660相对，该掩模轮668附着于掩模心轴664上，该丙烯酸类轮670环绕该掩模轮668。该丙烯酸类轮670，由于轴承间隔件666而自由转动，其提供了用于该基底卷幅648相当于该辊筒组合件658的接触表面。应当认识到该丙烯酸类轮670还能够由除丙烯酸类之外的其他光学透明材料制成。在该伺服电动机660转动该掩模轮668时，该轴承间隔件666为该掩模心轴664提供了转动支撑。如其所示，该掩模轮668具有一系列在激光焊接过程中遮蔽该卷幅664、668的多个区域的掩模部分672。各掩模部分包括在该卷幅644、648上限定出激光焊接区域的激光掩模孔口674。在操作过程中，激光器设置在该掩模轮668内，且该激光器将一个或多个激光束照射通过该激光孔口674以在该卷幅644、648之间形成与激光孔口674的形状相符的激光焊接处。通过转动该掩模轮668，该卷幅644、648能够以高速方式激光焊接在一起。所示实施方案中的激光孔口674是在掩模轮668中的物理开口，但在其他实施方案中，该激光孔口674能够是光学透明部分的形式。在所示的实施方案中，该激光孔口是U形的，以通常与环绕该生物传感器的毛细管通道的激光焊接区域相符合。应当认识到，根据该激光焊接处的所需形状，该激光孔口在不同实施方案中能够具有不同的形状。
再次参考图7A，高速激光传感器676在紧邻该激光焊接部分654之前沿基底卷幅648设置。该高速激光传感器676测量速度和/或通过肉眼观察基底卷幅648上的电极确定该基底卷幅648的相对位置。应当认识到，能够通过在该基底卷幅648上的目标记号间接检测该电极(或其他元件)的位置和/或速度。使用该激光传感器676，该辊筒组合件658的伺服电动机660能够将该掩模轮668的转动与该基底卷幅648的运动同步化。这种使掩模轮668的转动同步化的能力有助于确保在焊接过程中将该激光孔口674适当定位在该基底卷幅648上，以避免意外地焊接了错误的区域。如果可能，该激光传感器676应当位于辊筒组合件658的附近以使该基底卷幅648的拉伸影响最小化。在一种特别实施例中，该激光传感器676是Aromat UZF321PhotometricSensor(Panasonic Electric Works Corporation)，但应当认识到能够使用其他类型的传感器。
在该激光焊接部分654处，将该卷幅644、648在压辊656和辊筒组合件658之间挤压。该掩模轮668内的激光器将激光束引向挤压在一起的卷幅644、648。当其旋转到位时，该激光束照射通过该激光孔口674，同时该掩模轮668将卷幅644、648的剩余部分遮蔽以不受激光束的影响。假设该基底卷幅648是透明的，那么来自该激光孔口的激光束照射通过该基底卷幅648并被黑色的(或吸收性的)覆盖卷幅644吸收。所得到的热量使卷幅644、648熔化并熔合在一起，以形成焊接的生物传感器卷幅678。位于该激光焊接部分654的下游的检验照相机680检验该生物传感器卷幅678的任何缺陷以及维持工艺控制。在一种形式中，该检验照相机680是电荷耦合装置(CCD)照相机，但其能够包括其他类型的检验装置。在该激光焊接部分654的下游的主伺服传动装置682维持通常恒定的卷幅速度，并将焊接的生物传感器卷幅678卷绕在重绕卷轴684周围。该伺服传动装置以及该激光焊接系统640中的其他电动机能够来自多个来源，例如来自Rockwell Automation(Allen-Bradley)。
图10描述了上面关于图7A所述的激光焊接系统640的一种变型的前视图。图11显示了该激光焊接部分654的放大的透视图。类似前述，该激光焊接系统640包括覆盖供带盘642、基底供带盘646、供应伺服传动装置650、具有压辊656和辊筒组合件658的激光焊接部分654、主伺服传动装置682和重绕卷轴684。图10进一步描述了位于该辊筒组合件658内部的用于产生激光束的激光发生器686、和与该激光发生器686连接的用于调节该激光发生器686的相对位置的激光调节机构。图10中还显示了与该激光发生器和该系统的其他元件操作性连接的控制/动力系统690。这些控制/动力系统690用于为该系统的元件(例如该激光发生器686)提供动力并对其控制。压辊驱动器692与该压辊656连接用于驱动该压辊656。供应辊694和卸料辊696以相对于该辊筒658的三角形图案定向，以引导该卷幅以张紧方式通过该激光焊接部分。图10的系统中的激光焊接工艺通常以与上述相同的方式发生。
图7B中描述了使用相似的技术、原理和系统的三层压生物传感器的激光焊接工艺。图7B中的激光焊接系统698与图7A的激光焊接系统共享多个共用组件。为了简明和清楚，下面将不详细描述这些共用的组件，但请参见上面对其的描述。图7B中所示关注的一种额外元件是试剂分配器699，其用于以与上述离散分配需求相一致的方式分配该试剂。
图12描述了能够使用上述激光焊接技术制备的三层压生物传感器或测试条700的第一种实施方案的顶视图，图13显示了也能够使用上述激光焊接技术制备的三层压生物传感器或测试条702的第二种实施方案。如能够看到的那样，生物传感器700、702都具有相似的构造，电极结构除外。图12中的生物传感器700具有通过样品或毛细管腔706的侧部进入的电极704；而图13的生物传感器702的电极708通过该样品腔706的端部进入。两种生物传感器700、702都是以相同方式激光焊接在一起的。为了简要和清楚起见，将参照图12的生物传感器700描述用于激光焊接这些三层压生物传感器的技术，但也能够将相同的激光焊接技术容易地应用于制备图12的生物传感器702。
图14描述了第一种三层压生物传感器700的分解图，其包括透明的基底710、透明的上基层或覆盖层712和黑色的毛细管基层或间隔层714。再次应当认识到在其他实施方案中该多个透明的和黑色的层能够不同。该基底710具有电极704，在该样品腔706中，该电极704至少部分覆盖有试剂。该间隔层714具有开口716。其与基底710和覆盖层712一起形成了样品腔706。
如前面所暗示的那样，通常将该生物传感器700的多个层供应到辊筒或轮上，以使得能够通过连续工艺制备该生物传感器。图15显示了具有多个基底710的基底卷幅720的一个这种辊筒718的透视图，其以放大视图显示于图16中。图19显示了供给覆盖层卷幅730的辊筒728，其以放大视图显示于图20中。图17中的辊筒722供给在生物传感器700中形成间隔层714的间隔卷幅724。参看图18，其显示了间隔卷幅724的放大视图，最终构成间隔开口716的多个样品腔开口726限定在该间隔卷幅724中。然而将认识到，不使用在间隔卷幅724上预形成的开口726，其可以提供在紧邻间隔卷幅724之前(该间隔卷幅724被引入到该基底卷幅720中以确保该开口726适当地位于该电极704上在该样品腔706所需的位置)。参照图7B，可以在间隔卷幅724周围接近线性卷幅导向装置652和伺服传动装置650处提供冲压或切割装置(未示出)。辊筒组合件658处的传感器可以经构造以对控制器提供反馈(该控制器控制由切割装置进行的开口726的冲压/切割速率)。这种传感器，例如，可以确定在该卷幅720内相邻生物传感器中的电极704之间的实际间距，并对用于待提供的开口726的控制器的适当位置提供指示。如可以认识到的那样，这是用于确保组装用于本发明的三层压实施方案的所有卷幅的适当同步的额外装置。
转向图21，将该间隔卷幅724定位以覆盖包含工作电极、反电极和/或参比电极以及试剂的基底卷幅720的端部。该间隔卷幅724与基底卷幅720对齐(align)，以使样品腔开口与适合的电极和试剂对齐以形成样品腔706。参照图22，将该覆盖层卷幅730与该样品腔开口726的端部略微偏差地对齐以形成通风开口732，其用于在收集流体时排放来自样品腔706的空气。在所示的实施方案中，该基底卷幅720和该覆盖层卷幅730都是透明的，而该间隔卷幅724是黑色的。在激光焊接过程中，该激光束照射通过该透明的基底720和覆盖卷幅730，该激光束被吸收到该黑色的间隔卷幅724中。所得到的热量将该卷幅熔化并熔合在一起。图23显示了环绕该样品腔706的U形激光密封区域734的顶视图。再次应当认识到该基底卷幅720和该覆盖层卷幅730对该间隔卷幅724的激光密封能够同时或按顺序发生。沿截断线736截断过剩的卷幅材料，以得到生物传感器卷幅700，其示于图24中。
图25描述了依照另一实施方案的生物传感器740的透视图，其以与上述技术类似且只有以下提及的几个微小例外的方式激光焊接在一起。与前述类似，该生物传感器740包括基底742、覆盖层712和形成样品腔706的间隔层714。如能够看到的那样，该基底742具有与前述略微不同的电极结构744。转到图26，类似前述的实施方案，该形成间隔层714的黑色的间隔卷幅724和形成覆盖层712的透明的覆盖层卷幅730层压在形成基底742的基底卷幅746上。基底卷幅746、间隔卷幅724和覆盖层卷幅730的端部边缘分别由图26中的线748、750和752所示。在截断线754处除去过剩的卷幅材料，以形成该样品腔706的开口。一种明显的区别，当与图23中的焊接图案734相比较时，图26中的生物传感器740是不同的。如能够看到的那样，图26中的焊接图案756以连续方式拉伸。
尽管上面已经公开了包括本发明的原理的优选实施方案，但本发明并不限定于这些公开的实施方案。事实上，本申请意于覆盖落入本领域所属领域技术人员已知或常规实践的范围内以及落入后附权利要求的限定范围内的对本公开内容的那些偏离。
以下列出了本发明的优选实施方案：
1.生物传感器，包括：
基底，
覆盖在该基底上的至少一个覆盖层，其中该基底和该覆盖层共同限定出样品接受腔；
该基底和覆盖层中的一个比另一个更具透射性；
位于该样品接受腔内的试剂；
该基底和该覆盖层提供了沿两者之间的边缘的用于该样品接受腔的开口；和
至少一个激光焊接处，其将该基底与该覆盖层相连接，以形成该样品接受腔。
2.实施方案1的生物传感器，进一步包括在该基底上形成的电极。
3.实施方案2的生物传感器，其中该电极是激光烧蚀电极。
4.实施方案1的生物传感器，其中的更不具透射性的那个层是黑色的。
5.实施方案1的生物传感器，其中该基底是基本透明的。
6.实施方案1的生物传感器，其中该基底是基本透明的，且该覆盖层是基本黑色的。
7.实施方案1的生物传感器，其中该基底是基本黑色的，且该覆盖层是基本透明的。
8.实施方案1的生物传感器，进一步包括在该基底上的间隔层，所述覆盖层位于该间隔层之上，所述至少一个激光焊接处包括将所述基底与所述间隔层相连接的至少一个激光焊接处和将所述间隔层与所述覆盖层相连接的至少一个激光焊接处，其中所述基底、所述间隔层和所述覆盖层连接形成所述样品接受腔。
9.实施方案8的生物传感器，其中所述覆盖层和所述基底比所述间隔层更具透射性。
10.实施方案9的生物传感器，其中：
所述基底是基本透明的，
所述间隔层是黑色的；和
所述覆盖层是基本透明的。
11.实施方案1的生物传感器，进一步包括激光焊接在所述基底和所述覆盖层之间的间隔层，以限定出所述样品接受腔。
12.实施方案11的生物传感器，进一步包括：
与所述间隔层相连接的主体盖；和
该主体盖与所述覆盖层间隔开以限定出用于将空气从所述样品接受腔排出的通风缝隙。
13.实施方案12的生物传感器，其中所述主体盖激光焊接到所述间隔层上。
14.实施方案1的生物传感器，其中所述试剂是亲水的。
15.实施方案1的生物传感器，其中至少所述覆盖层具有通道凹槽以形成样品接受腔。
16.实施方案1的生物传感器，其中所述基底和所述覆盖层中的至少一个是由聚碳酸酯制成的。
17.实施方案1的生物传感器，其中所述基底和所述覆盖层中的至少一个是由聚酯制成的。
18.实施方案1的生物传感器，其中所述覆盖层限定了定位以将空气从所述样品接受腔排出的通风孔。
19.实施方案1的生物传感器，其中所述基底和所述覆盖层是围绕所述样品接受腔周缘的至少一部分激光焊接的。
20.实施方案1的生物传感器，其中所述基底和所述覆盖层具有激光焊接区域，在此处所述基底和所述覆盖层焊接在一起。
21.实施方案1的生物传感器，其中所述样品接受腔具有约20～约200nL的容积。
22.生物传感器，包括：
基底；
覆盖层；
一个或多个激光焊接处，其与所述基底和所述覆盖层共同限定了其尺寸使得降低血样中的血细胞比容干扰的微毛细管腔；和
位于所述微毛细管腔内用以分析所述血样的试剂。
23.实施方案22的生物传感器，其中所述一个或多个激光焊接处直接将所述覆盖层焊接到所述基底上。
24.实施方案22的生物传感器，进一步包括激光焊接在所述基底和所述覆盖层之间用以限定出所述微毛细管腔的间隔件。
25.实施方案22的生物传感器，其中所述基底具有一个或多个用于分析血样的电极。
26.实施方案22的生物传感器，其中所述基底和所述覆盖层中的一个比另一个在所述一个或多个激光焊接处处对激光能量更具吸收性。
27.方法，包括：
将试剂沉积在基底上；和
将所述基底和覆盖层激光焊接在一起，以形成包含所述试剂的生物传感器的样品接受腔。
28.实施方案27的方法，进一步包括：
形成与所述样品接受腔连通的通风口。
29.实施方案27的方法，其中：
所述基底和所述覆盖层中的一个比另一个更透明；和
所述形成样品接受腔包括通过引导激光束穿过更透明的那个来穿过更透明的那个激光焊接。
30.实施方案29的方法，其中：
所述基底对所述激光束是基本透明的；
所述覆盖层经构造以基本吸收所述激光束；和
所述形成样品接受腔包括将所述激光束照射穿过所述基底并作用于(against)所述覆盖层。
31.实施方案27的方法，进一步包括：
其中所述覆盖层和基底具有共同的同延(co-extensive)边缘；和
沿所述基底和覆盖层的同延边缘形成所述样品接受腔的开口。
32.实施方案27的方法，进一步包括：
提供所述基底和所述覆盖层的连续卷幅；
其中所述激光焊接包括将所述基底和所述覆盖层的连续卷幅激光焊接在一起以形成层压物，其中所述层压物包括多个包含所述试剂的样品接受腔；和
沿所述基底和覆盖层中至少一个的边缘形成各样品接受腔的开口。
33.实施方案32的方法，其中所述激光焊接包括：
转动旋转型掩模，同时从而使所述基底和所述覆盖层的连续卷幅运动，其中所述旋转型掩模包括多个掩模孔口；以及
将激光束照射穿过至少一个所述掩模孔口，以在所述连续卷幅之间形成激光焊接处。
34.实施方案33的方法，进一步包括：
将所述基底卷幅与所述旋转掩模的速度同步，以使得在所述激光焊接过程中所述掩模孔口恰当地对齐。
35.实施方案32的方法，进一步包括：
将所述连续卷幅分成多个生物传感器测试条。
36.实施方案27的方法，其中：
所述激光焊接包括沿所述样品接受腔的圆周激光焊接。
37.实施方案27的方法，其中：
所述激光焊接包括焊接所述样品接受腔周围的区域。

Claims (15)

1.生物传感器，包括：
基底，
覆盖在所述基底上的至少一个覆盖层，其中所述基底和所述覆盖层共同限定出样品接受腔；
所述基底和覆盖层中的一个比另一个更具透射性；
位于所述样品接受腔内的试剂；
所述基底和所述覆盖层提供了沿两者之间的边缘的用于所述样品接受腔的开口；和
至少一个激光焊接处，其将所述基底与所述覆盖层相连接，以形成所述样品接受腔。
2.权利要求1的生物传感器，进一步包括在所述基底上形成的电极。
3.权利要求1的生物传感器，进一步包括激光焊接在所述基底和所述覆盖层之间以限定出所述样品接受腔的间隔层。
4.权利要求3的生物传感器，进一步包括：
与所述间隔层相连接的主体盖；和
所述主体盖与所述覆盖层间隔开以限定出用于将空气从所述样品接受腔排出的通风缝隙。
5.权利要求4的生物传感器，其中所述主体盖激光焊接到所述间隔层上。
6.权利要求1的生物传感器，其中至少所述覆盖层具有通道凹槽以形成所述样品接受腔。
7.权利要求1的生物传感器，其中所述基底和所述覆盖层是围绕所述样品接受腔周缘的至少一部分激光焊接的。
8.权利要求1的生物传感器，其中所述样品接受腔具有约20～约200nL的容积。
9.权利要求1～8的生物传感器，其中所述样品接受腔是其尺寸使得降低血样中血细胞比容干扰的微毛细管腔；且包括位于所述微毛细管腔内用以分析所述血样的试剂。
10.权利要求9的生物传感器，其中所述基底和所述覆盖层中的一个比另一个在所述一个或多个激光焊接处对激光能量更具吸收性。
11.方法，包括：
将试剂沉积在基底上；和
将所述基底和覆盖层激光焊接在一起，以形成包含所述试剂的生物传感器的样品接受腔。
12.权利要求11的方法，其中：
所述基底和所述覆盖层中的一个比另一个更透明；和
所述形成样品接受腔包括通过引导激光束穿过更透明的那个来穿过更透明的那个激光焊接。
13.权利要求11的方法，进一步包括：
提供所述基底和所述覆盖层的连续卷幅；
其中所述激光焊接包括将所述基底和所述覆盖层的连续卷幅激光焊接在一起以形成层压物，其中所述层压物包括多个包含所述试剂的样品接受腔；和
沿所述基底和覆盖层中至少一个的边缘形成各样品接受腔的开口。
14.权利要求13的方法，其中所述激光焊接包括：
转动旋转型掩模，同时从而使所述基底和所述覆盖层的连续卷幅运动，其中所述旋转型掩模包括多个掩模孔口；以及
将激光束照射穿过至少一个所述掩模孔口，以在所述连续卷幅之间形成激光焊接处。
15.权利要求11的方法，其中：
所述激光焊接包括围绕所述样品接受腔的周缘激光焊接，或焊接所述样品接受腔周围的区域。
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