CN101080199B - 用于制造刺入元件的方法 - Google Patents
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Abstract
本发明涉及一种用于制造刺入元件的方法，其中在应用掩模(24)的情况下并且在蚀刻剂的作用下由扁材(22)制成扁平成形件(12)，其中所述扁平成形件(12)的至少一部分构造成尖端(16、16’)。按本发明在此提出，所述掩模(24)设有用于有待形成的尖端(16、16’)的成形区(30)以及在远端超过该尖端(16、16’)延伸的、防止该尖端(16、16’)遭受正面蚀刻的隔离区(32)，并且通过所述成形及隔离区(32)的侧面(34、36)的侧面根蚀来显露出锋利的尖端(16、16’)。
Description
技术领域
本发明涉及一种用于制造尤其用于提取体液的刺入元件的方法，其中在应用掩模的情况下并且在蚀刻剂的作用下由扁材制成扁平成形件，其中所述扁平成形件的至少一部分成形为用于刺入受检者身体部位中的尖端。
背景技术
这种类型的刺入元件特别在生物分析中允许对最小的流体量进布检查，就象比如为了在现场进行血糖测定而作为毛细血管血液所抽取的一样。在此，这样的微型流体系统的突出之处除了微小的量(微升以及更少)之外，也在于尺寸越来越小的结构元件，所述结构元件可以利用毛细力并且以所谓的一次性用品适合于批量生产。虽然在半导体工艺领域中已经公开了特别是掩模蚀刻(“photochemical etching(光化蚀刻)”)形式的用于高度集成系统的制造方法；但那里所使用的材料首先由于其脆性几乎不可以用于承受机械负荷的结构。在对生物相容的材料比如钢进行蚀刻时，使用传统的形状补偿的蚀刻掩模会出现这样的问题，即所产生的刺入结构被圆化并且由此不能进行特别理想的刺入作业。
在US 4777096A中公开了一种用于制造外科用针的蚀刻方法，其中，所述蚀刻掩模在远端的变钝的成形区域中延伸超过有待形成的尖端，由此避免圆化现象。但这个掩模突出部分比蚀刻剂的根蚀宽度短，从而所述尖端通过共同的侧面的及正面的蚀刻作用来成形，由此仅仅稍微降低了这种钝化问题。
发明内容
据此，本发明的任务是避免在现有技术中出现的缺点，并且改进开头所述类型的制造方法，从而在适合于批量生产的工艺过程中提供用于理想地刺入身体部位中的锋利的刺入结构，而不需要开销很大的精加工步骤。
为解决该任务，提出了在独立权利要求中所说明的特征组合。本发明优选的设计方案和改进方案由从属权利要求中获得。
本发明基于这样的构思，即仅仅通过在侧面朝彼此收缩的蚀刻剂前锋创造锋利的尖端。与此相对应，按本发明提出，所述掩模设有用于有待形成的尖端的成形区以及在远端超过该尖端延伸的防止尖端遭受正面蚀刻的隔离区，并且通过所述成形及隔离区的侧面的侧面根蚀来显露出锋利的尖端。在这过程中可以在尖端的区域中避免轮廓圆化，其中一旦处于所述蚀刻掩模的侧面之间的材料桥断裂，那就结束所述蚀刻过程。通过这种方式可以提供理想的尖端，以便保持很小的刺入疼痛，并且可以以尽可能小的尺寸提取体液。此外，可以将对于刺入过程来说所必需的进给力减小到最低限度，并且可以在很大程度上避免身体组织的创伤。
优选所述蚀刻掩模的成形区朝所述隔离区逐渐变窄，从而产生朝所述尖端收缩的刺入杆。在此优选至少在一侧上对所述成形区进行直线斜切。
按照另一种优选的实施方式，至少一个侧面在成形区和隔离区之间的过渡区域中进行折弯或者弯曲成凹形，从而所述基材在有待产生的尖端的区域中仅仅从侧面被剥蚀。
无论如何应该保证，所述隔离区在给定的隔离长度上在所述成形区之后具有保持相同的或者增加的宽度。在此，所述隔离长度大于由于蚀刻剂的作用产生的近端的根蚀宽度。由此可靠地防止对所述尖端的中心蚀刻。
优选所述尖端由于掩模的狭窄处而成形，其中所述狭窄处的宽度应该小于两倍的侧面根蚀宽度，使得所述处于该狭窄处下面的基材完全地被剥蚀。
优选所述隔离区在所述狭窄处之后再次加宽。同样为了改进蚀刻掩模的稳定性，优选所述隔离区具有朝所述有待形成的尖端的远端的方向看加宽的桥接段。
在钢中的蚀刻过程主要以各向同性的方式进行，也可以设想，所述侧面的根蚀宽度大于或小于蚀刻深度。这样比如出现各向异性现象，如果在相对于环境的过压下使用该蚀刻剂，用于确保特别有效的作用。该蚀刻剂可以在浸渍池中或者通过喷注施加到所述扁材上。
为得到高产量，优选通过光化学掩模蚀刻一卷一卷地对所述优选由特种钢板制成的扁材进行加工。但也可以设想，将半导体晶片用作扁材。
优选所述扁材的厚度处于1毫米和0.01毫米之间。
按照另一种优选的设计方案，所述刺入元件通过在掩模中的通道缝隙设置半开的毛细通道用于输送体液，其中通道壁体在其远端的端部上构造为锋利的尖端。在此，所述用于通道壁体的尖端的隔离区在一侧受到所述通道缝隙的限制。
对于一种特殊的成形件造型来说，所述扁材在两侧设有掩模，其中在其中一侧上蚀刻出尖形的刺入杆，并且在另一侧上蚀刻出在所述刺入杆上延伸的、具有尖形通道壁体的半开的毛细通道。
按照本发明的另一方面，所述蚀刻掩模与根蚀的边缘区段保持侧面间距地设置补偿开口，并且穿过所述补偿开口在所述蚀刻剂的作用下在棱边侧上对所述扁平成形件的边缘轮廓进行蚀刻。通过这种方式，可以在没有额外的制造开销的情况下对不受欢迎的成形件底切进行化学铣削。
为消除棱边，有利的是所述补偿开口优选作为缝隙或者孔链在掩模中沿所述边缘区段延伸。在此，所述补偿开口具有比与所述边缘区段邻接的掩模凹处小的开口宽度。
为了实现对在所述掩模边缘与所述补偿凹处之间延伸的材料桥施加组合根蚀作用，所述处于其上面的掩模桥的宽度应该小于蚀刻剂从所述掩模边缘开始的根蚀宽度。
根据所期望的轮廓曲线，所述补偿开口布置在成形区并且必要时布置在所述掩模的用于有待形成的尖端的隔离区中。尤其有利的是所述补偿开口与所述掩模的折弯的或者弯曲成凹形的侧面保持侧面间距地布置。
为了即使在这种情况下也防止所述尖端遭受正面蚀刻，尤其优选在朝有待形成的尖端的方向延伸的中心轴线的侧面加入所述补偿开口，从而在所述尖端之前得到至少在超过所述根蚀宽度的范围内沿该中心轴线的掩模带。在原理上，在此适用在避免所述蚀刻剂的正面作用方面和上面关于所述掩模边缘所作的解释相同的考虑。也就是无论如何要避免所述补偿开口的V形轮廓。
附图说明
下面借助于在附图中示意示出的实施例对本发明进行详细解释。
其中：
图1是具有尖端和毛细通道的用于取血的刺入元件的俯视图；
图2是用于制造所述刺入元件的尖端的背面的蚀刻掩模的俯视图；
图3是用于在所述尖端的区域中制造毛细通道的前面的蚀刻掩模的俯视图；
图4是所述蚀刻掩模的在所述毛细通道的远端的端部区域中的放大的截取部分的俯视图；
图5是沿着图4的线条5-5的剖面；
图6是沿着图4的线条6-6的剖面；
图7到9是另一种实施例的相应于图4到6的视图，该实施例在所述蚀刻掩模中具有补偿缝隙；并且
图10是用于制造尖端的按现有技术的蚀刻掩模的俯视图。
具体实施方式
在附图中示出的刺入元件或者说取样元件10作为一次性部件用于从受检者的身体部位中提取并且毛细输送少量血液，尤其用于进行血糖测量。为此该元件包括扁平成形件12、成形在该扁平成形件上的具有尖端16的刺入机构14以及半开的毛细通道18，该毛细通道18用于以毛细方式将血液从所述尖端16输送到分析位置20。
所述扁平成形件12由特种钢板22制成，该特种钢板22的厚度大约为100到300微米。该扁平成形件12的近端的端部区段形成一个用于在刺入过程中进行操纵的握持区，而所述在远端的端部上一体成形的刺入机构14在使用者的皮肤中产生一个小伤口，用于能够提取微量的血液量。在这种情况下，所述毛细通道18在其长度上构造为沟槽形的或者说半开的，从而可以如下面所描述的一样用光刻法进行制造。所提取的血样的分析比如可以通过反射光谱法或者电化学证明法以公知的方式得以实现。
所述板材或者说基底的结构化根据PCM-方法进行(英语“photochemical machining(光化学加工)”或者“milling(研磨)”)。在此，所述基底22优选在两侧设有蚀刻掩模24，该蚀刻掩模24盖住要在下面的蚀刻步骤中显露的成形件结构。为形成掩模，用光致抗蚀剂(“photoresist”)对所述基底22进行涂覆，并且通过前置的具有所期望的图形(Muster)的光掩模进行曝光，其中所述光致抗蚀剂在覆盖区域中聚合或者说硬化，而其余的区域则在显影之后进行冲洗。
随后，通过如此产生的(双面)蚀刻掩模24给所述基底22加载蚀刻剂，从而根据基本形状对标记出的区域进行自由蚀刻。在进行各向同性的蚀刻作用时，材料剥蚀的深度相当于在对掩模24的边缘轮廓进行根蚀时的侧面蚀刻率。通过外部的影响参数或者说所述基底的材料特性，也可以按各向异性的方式进行所述蚀刻过程，也就是说所述侧面的根蚀率大于或者小于深蚀刻率。
对所述刺入元件10的功能来说尤为关键的是所述尖端16的制造。按照图10，根据现有技术的最近的解决方案在于，为相应的蚀刻掩模配设逐渐变尖的或者三角形的、相应于成品件的所期望轮廓的成形区26。但在此观察到，如此形成的尖端28不是锋利的，而是在对三角形掩模26进行根蚀时由于从各方向涌入的蚀刻剂被圆化。
为避免这一点，所述按本发明的蚀刻掩模24具有用于有待形成的尖端16的成形区30以及远端的-从刺入方向看上去-紧接在尖端后面的、防止该尖端16遭受正面蚀刻的隔离区32。所述成形区30朝所述隔离区32逐渐变细，其中以直线坡度将所述掩模24的侧面34、36切成斜面。从狭窄处38开始，所述隔离区32在形成桥接段40的情况下朝其余的掩模区域加宽，使得所述蚀刻掩模24在总体上保持更加稳定。
通过对所述成形及隔离区30、32的侧面34、36进行的侧面根蚀，由此蚀刻出锋利的尖端16，在图2中以虚线示出了该尖端16的轮廓。在此，所述隔离区32在近端的方向看上去具有大于根蚀宽度的隔离长度，而所述狭窄处38的宽度则小于双倍的侧面根蚀宽度。通过这种方式，所述蚀刻的材料正面在该狭窄处38上一直朝彼此收缩，直到最后在蚀刻过程结束时显露出所述尖端16。
所述掩模24的在图3中示出的前面的截取部分构造为和在所述刺入机构14的区域中所期望的毛细结构18互补的结构。因此，所述掩模24具有毛细缝隙42，通过该毛细缝隙42在形成通道壁体44的情况下对所述通道18进行蚀刻。为了也在这里减轻刺入过程，将所述通道壁体44在其远端的端部上作为锋利的尖端16’进行斜切。这一点按照上述方式通过前置的隔离区32得到实现，其中在图3中在功能上相同的部件具有相同的附图标记，从而可以参照前面的解释。与图2所不同的是，所述侧面34、36在狭窄处38的区域中没有在两侧弯曲成凹形，而是在一侧弯成钝角，并且在对置的一侧受到所述毛细缝隙42的直线限制，从而形成如虚线所示的楔形尖端16’。
在图4到6中，说明了在所述通道尖端16’的区域中蚀刻过程的原理上的几何影响。图5、6在此仅仅示出在一定的蚀刻时间之后上面的基底区域，其中所述侧面的蚀刻轮廓46仅仅在进行各向同性的蚀刻作用时说明一条圆周线。通过对所述掩模24的掩模边缘或者说侧面34、36进行的侧面的根蚀，由此产生底切的成形件棱边48、50，在图5中可以最清楚地看出这一点。这样的底切在所述毛细通道18的区域中完全是所期望的，因为由此进一步改进了毛细作用。但在所述尖端16、16’上因所述底切52而产生倒钩(图6)，该倒钩会影响到在皮肤中的刺入。
为了在这里提供补救措施，可以在按图7和8的掩模24中留下一条补偿缝隙54。该补偿缝隙54与根蚀的边缘区段56保持侧面间距地在所述掩模24的成形区30中延伸，并且使得所产生的其余部分的底切48在棱边侧被蚀刻。通过所述补偿缝隙54在靠近棱边的地方渗入的蚀刻剂由此在避免倒钩的情况下导致产生锐棱倒圆58。优选所述掩模带60在所述掩模边缘56和补偿缝隙54之间的宽度小于所述侧面的根蚀宽度。在此应该保证，所述补偿缝隙54与相邻的掩模凹处62相比具有小得多的开口宽度，使得所述锐棱倒圆58具有相应更小的蚀刻半径。
Claims (28)
1.用于制造用于提取体液的刺入元件的方法，其中在应用掩模(24)的情况下并且在蚀刻剂的作用下由扁材(22)制成扁平成形件(12)，其中该扁平成形件(12)的至少一部分成形为用于刺入受检者的身体部位中的尖端(16、16’)，其中所述掩模(24)设有用于有待形成的尖端(16、16’)的成形区(30)以及在远端超过该尖端(16、16’)延伸的、防止该尖端(16、16’)遭受正面蚀刻的隔离区(32)，其特征在于，成形区(30)的和隔离区(32)的至少一个侧面(34)在成形区(30)和隔离区(32)之间的过渡区域中折弯或者弯曲成凹形，从而所述隔离区(32)在给定的隔离长度上在所述成形区(30)之后具有保持相同的或者逐渐增加的宽度，并且仅仅通过对所述成形及隔离区(32)的侧面(34、36)进行侧向的根蚀来显露出锋利的尖端(16、16’)。
2.按权利要求1所述的方法，其特征在于，所述成形区(30)朝所述隔离区(32)变窄。
3.按权利要求1或2所述的方法，其特征在于，对所述成形区(30)至少在一侧进行直线斜切。
4.按权利要求1所述的方法，其特征在于，所述隔离长度大于由于蚀刻剂的作用产生的近端的根蚀宽度。
5.按权利要求1所述的方法，其特征在于，所述尖端(16、16’)通过所述掩模(24)的狭窄处(38)成形。
6.按权利要求5所述的方法，其特征在于，所述狭窄处(38)的宽度小于两倍的侧面的根蚀宽度。
7.按权利要求5或6所述的方法，其特征在于，所述隔离区(32)在所述狭窄处(38)之后再次变宽。
8.按权利要求1所述的方法，其特征在于，所述隔离区(32)具有朝所述有待形成的尖端(16、16’)的远端的方向看上去逐渐加宽的桥接段(40)。
9.按权利要求1所述的方法，其特征在于，所述侧面的根蚀宽度大于或小于所述蚀刻深度。
10.按权利要求1所述的方法，其特征在于，所述蚀刻剂在浸渍池中或者通过喷注加到所述扁材上。
11.按权利要求1所述的方法，其特征在于，在相对于周围环境的过压下应用所述蚀刻剂。
12.按权利要求1所述的方法，其特征在于，通过光化学掩模蚀刻一卷一卷地对所述优选由特种钢板制成的扁材(22)进行加工。
13.按权利要求1所述的方法，其特征在于，所选择的扁材(22)厚度在1毫米和0.01毫米之间。
14.按权利要求1所述的方法，其特征在于，所述刺入元件通过在所述掩模(24)中的通道缝隙(42)设置用于输送体液的半开毛细通道(18)，并且所述通道壁体(44)在其远端的端部上构造为锋利的尖端(16’)。
15.按权利要求14所述的方法，其特征在于，所述用于通道壁体(44)的尖端(16’)的隔离区(32)在一侧受到所述通道缝隙(42)的限制。
16.按权利要求1所述的方法，其特征在于，所述扁材(22)在两侧设有掩模(24)，其中在其中一侧上蚀刻出尖形的刺入杆(14)，并且在另一侧上蚀刻出具有尖形的通道壁体(44)的在所述刺入杆(14)上延伸的半开的毛细通道(18)。
17.按权利要求1所述的方法，其特征在于，所述掩模(24)与经受根蚀的边缘区段(56)保持侧面间距地设有补偿开口(54)，并且通过所述补偿开口(54)在蚀刻剂的作用下在棱边侧对所述扁平成形件(12)的边缘轮廓(48)进行蚀刻。
18.按权利要求17所述的方法，其特征在于，所述补偿开口(54)优选作为缝隙或者孔链在所述掩模(24)中沿所述边缘区段(56)延伸。
19.按权利要求17所述的方法，其特征在于，所述补偿开口(54)具有比与所述边缘区段(56)邻接的掩模凹处(62)小的开口宽度。
20.按权利要求17所述的方法，其特征在于，在所述掩模边缘和所述补偿开口(54)之间延伸着掩模桥(60)，并且所述掩模桥(60)的宽度小于所述蚀刻剂从掩模边缘开始的根蚀宽度。
21.按权利要求17所述的方法，其特征在于，所述补偿开口(54)布置在成形区(30)中，并且必要时布置在所述掩模(24)的用于有待形成的尖端(16、16’)的隔离区(32)中。
22.按权利要求17所述的方法，其特征在于，所述补偿开口(54)与所述掩模(24)的在远端超过有待形成的尖端(16、16’)的折弯的或者弯曲成凹形的侧面(34)保持侧面间距地布置。
23.用于制造用于提取体液的刺入元件的方法，其中在应用掩模(24)的情况下并且在蚀刻剂的作用下由扁材(22)制成扁平成形件(12)，其中所述扁平成形件(12)的至少一部分构造成用于刺入受检者的身体部位中的尖端(16、16’)，其中所述掩模(24)与用于有待形成的尖端的所述掩模的成形区的经受根蚀的边缘区段(56)侧向间隔地设有补偿开口(54)，并且通过所述补偿开口(54)在蚀刻剂的作用下在棱边侧对所述扁平成形件(12)的边缘轮廓(48)进行蚀刻，其特征在于，仅仅在朝有待形成的尖端(16、16’)的方向延伸的中心轴线的侧面加入所述补偿开口(54)，从而沿着所述中心轴线在所述尖端(16、16’)之前保持掩模带并且防止所述尖端(16、16’)遭受正面蚀刻。
24.按权利要求23所述的方法，其特征在于，所述补偿开口(54)优选作为缝隙或者孔链在所述掩模(24)中沿所述边缘区段(56)延伸。
25.按权利要求23所述的方法，其特征在于，所述补偿开口(54)具有比与所述边缘区段(56)邻接的掩模凹处(62)小的开口宽度。
26.按权利要求23所述的方法，其特征在于，在所述掩模边缘和所述补偿开口(54)之间延伸着掩模桥(60)，并且所述掩模桥(60)的宽度小于所述蚀刻剂从掩模边缘开始的根蚀宽度。
27.按权利要求23所述的方法，其特征在于，所述补偿开口(54)布置在成形区(30)中，并且必要时布置在所述掩模(24)的用于有待形成的尖端(16、16’)的隔离区(32)中。
28.按权利要求23所述的方法，其特征在于，所述补偿开口(54)与所述掩模(24)的在远端超过有待形成的尖端(16、16’)的折弯的或者弯曲成凹形的侧面(34)保持侧面间距地布置。
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- 2004-12-17 EP EP04029926A patent/EP1671585A1/de not_active Withdrawn
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2005
- 2005-12-10 BR BRPI0515789A patent/BRPI0515789B8/pt not_active IP Right Cessation
- 2005-12-10 PL PL05824859T patent/PL1830707T3/pl unknown
- 2005-12-10 JP JP2007545909A patent/JP4838264B2/ja not_active Expired - Fee Related
- 2005-12-10 AT AT05824859T patent/ATE508689T1/de active
- 2005-12-10 CA CA2592310A patent/CA2592310C/en not_active Expired - Fee Related
- 2005-12-10 KR KR1020077013616A patent/KR101055237B1/ko active IP Right Grant
- 2005-12-10 WO PCT/EP2005/013266 patent/WO2006066744A1/de active Application Filing
- 2005-12-10 ES ES05824859T patent/ES2363437T3/es active Active
- 2005-12-10 EP EP05824859A patent/EP1830707B1/de not_active Not-in-force
- 2005-12-10 MX MX2007007020A patent/MX2007007020A/es active IP Right Grant
- 2005-12-10 AU AU2005318594A patent/AU2005318594B2/en active Active
- 2005-12-10 CN CN2005800433505A patent/CN101080199B/zh not_active Expired - Fee Related
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| US4777096A (en) * | 1984-12-14 | 1988-10-11 | Ethicon, Inc. | Sheet containing a plurality of surgical needles |
| US5057401A (en) * | 1990-03-07 | 1991-10-15 | Ethicon, Inc. | Process for making a device with a three-dimensionally tapered point |
Also Published As
| Publication number | Publication date |
|---|---|
| BRPI0515789A (pt) | 2008-08-05 |
| CA2592310C (en) | 2011-10-18 |
| US20080040919A1 (en) | 2008-02-21 |
| EP1830707B1 (de) | 2011-05-11 |
| EP1830707A1 (de) | 2007-09-12 |
| PL1830707T3 (pl) | 2011-10-31 |
| JP2008523855A (ja) | 2008-07-10 |
| MX2007007020A (es) | 2007-07-04 |
| US8087141B2 (en) | 2012-01-03 |
| BRPI0515789B1 (pt) | 2018-11-06 |
| ATE508689T1 (de) | 2011-05-15 |
| KR101055237B1 (ko) | 2011-08-08 |
| BRPI0515789B8 (pt) | 2021-06-22 |
| EP1671585A1 (de) | 2006-06-21 |
| CA2592310A1 (en) | 2006-06-29 |
| AU2005318594B2 (en) | 2011-03-17 |
| AU2005318594A1 (en) | 2006-06-29 |
| KR20070087611A (ko) | 2007-08-28 |
| WO2006066744A1 (de) | 2006-06-29 |
| HK1116377A1 (en) | 2008-12-24 |
| CN101080199A (zh) | 2007-11-28 |
| JP4838264B2 (ja) | 2011-12-14 |
| ES2363437T3 (es) | 2011-08-04 |
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