CN101801269A - 刺扎系统和带盒 - Google Patents

刺扎系统和带盒 Download PDF

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CN101801269A
CN101801269A CN200880108177A CN200880108177A CN101801269A CN 101801269 A CN101801269 A CN 101801269A CN 200880108177 A CN200880108177 A CN 200880108177A CN 200880108177 A CN200880108177 A CN 200880108177A CN 101801269 A CN101801269 A CN 101801269A
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carrier band
roller
winding
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CN101801269B (zh
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H·哈蒂格
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F Hoffmann La Roche AG
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
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    • A61B5/150358Strips for collecting blood, e.g. absorbent
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • AHUMAN NECESSITIES
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    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
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    • A61B5/150503Single-ended needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15113Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/15101Details
    • A61B5/15115Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • AHUMAN NECESSITIES
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    • A61B5/15101Details
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    • A61B5/15128Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads
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    • A61B5/15149Arrangement of piercing elements relative to each other
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    • A61B5/15146Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15165Piercing elements stocked in or on a strip
    • A61B5/15169Characterized by a rolled strip
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    • A61B5/15157Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15165Piercing elements stocked in or on a strip
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    • A61B5/15146Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
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    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15178Stocking means comprising separate compartments or units for new and for used piercing elements
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    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/11Automated chemical analysis
    • Y10T436/110833Utilizing a moving indicator strip or tape

Abstract

本发明涉及一种刺扎系统,其带有:载体带(1),该载体带(1)承载着多个刺血针(2);第一绕卷辊(3),带有未使用的刺血针(2)的载体带(1)卷绕到该第一绕卷辊(3)上;第二绕卷辊(4),用于卷绕已使用的刺血针(2)的载体带截段;绕卷驱动器(6),用于通过第二绕卷辊(4)的转动将由载体带(1)承载的刺血针(2)依次带到使用位置中并在此自第一绕卷辊(3)上解绕载体带(1)和将载体带(1)卷绕到第二绕卷辊(4)上;刺扎驱动器(7),用于使处于使用位置的刺血针(2)为了穿刺而加速。根据本发明作如下设置,即,载体带(1)在第一与第二绕卷辊(3,4)之间仅仅沿着一个转动方向地扭转至少一个四分之一转,优选地扭转至少一个二分之一转。

Description

刺扎系统和带盒
本发明涉及带有在权利要求1的前序部分中给出的特征的刺扎系统(Stechsystem)及用于刺扎系统的带盒(Bandkassette)。这种类型的刺扎系统可由文件WO 2005/107596A2了解到。
刺扎系统(例如)被糖尿病患者所需要,糖尿病患者必须每天多次检查其血糖水平且为此需要从穿刺伤口获得的体液样品,通常为血液或组织液(interstitielle Flüssigkeit)。刺扎系统可包括刺扎器械
Figure GPA00001066859100011
及带有刺血针载体带
Figure GPA00001066859100012
的可更换的带盒,或者设计成一次性的器械,在该一次性的器械中,未设置有布置在其中的刺血针载体带的更换。
利用刺血针载体带可以节省空间的方式提供更大的刺血针储量。因此,利用刺血针载体带来工作的刺扎器械在尽管存在较大的内部刺血针储量的情形下仍可构造得非常紧凑。尤其对于必须始终随身携带刺扎器械的使用者来说,这一点意味着较大的负担减轻。
本发明的任务在于指出一种途径,进一步改善利用刺血针载体带而工作的刺扎系统。
该任务根据本发明如此来完成,即,载体带在第一与第二绕卷辊(Wickelrolle)之间仅仅沿着一个转动方向地扭转(verdrillen)至少一个四分之一转(Vierteldrehung),优选地扭转至少一个二分之一转(Halbdrehung)。
通过载体带的四分之一转可实现,载体带的截段处于横向于第一绕卷辊的几何转动轴线的位置。在该横向地置放的截段中,刺血针(Lanzette)可为了实现穿刺以简单的方式横向于第一绕卷辊的几何转动轴线而移动。刺扎器械可因此与位于壳体中的绕卷辊一起平坦地设计,并以人体工程学角度有利的方式刺扎到贴靠到器械的窄侧面上的身体部分(通常为手指)中。
该带在四分之一转之后是否可保持其取向或者需要额外的扭转尤其取决于第二绕卷辊的几何转动轴线的相对于第一绕卷辊的转动轴线的取向。两个绕卷辊的转动轴线优选地平行,从而,载体带在卷绕到第二绕卷辊上之前应完成第二个四分之一转。
原则上,在带有平行地伸延的绕卷辊几何转动轴线的器械中载体带的四分之一转的有利之处可通过如下方式而被利用,即,第一个四分之一转通过带有相反地设定的转动方向的第二个四分之一转而被倒退。在这种情况下,载体带将在两个绕卷辊之间沿着两个不同的转动方向扭转。
然而,如果载体带仅仅沿着单一的转动方向扭转,则是显著地更有利的。在带有平行地伸延的绕卷辊转动轴线的刺扎系统中这意味着,第一个四分之一转并不通过第二个四分之一转而被倒退,而是,载体带沿着第一个四分之一转的转动方向继续转动,优选地转动恰好另一个四分之一转,使得载体带总共扭转二分之一转。
如果载体带仅仅沿一个转动方向地扭转,则与自平衡的(kompensierenden)、相反地设定的四分之一转的情况相比,需要较少的带引导元件。较少的带引导元件不仅意味着刺扎系统的更简单且因此更经济的结构,并且还意味着更小的摩擦。
所存在的带引导元件越少,则通常作用到载体带上的摩擦面和/或接触角(载体带通过带引导元件以该接触角而被偏转)也就越小。降低的摩擦意味着较小的力即可足够用于带输送。在其中带输送通过电马达来实现的刺扎系统因此可利用功率较低的马达来实现且需要较少的电能。对于许多用户而言令人厌烦的电池充电或电池更换可更少地进行,或者该器械可通过应用更小的电池而被设计得更轻并且更紧凑。在更简单的刺扎系统(其设置有通过由用户施加的力来实现的带输送)中,尤其对于其手动灵活性由于年龄或疾病而受到限制的用户而言,降低的摩擦意味着受欢迎的负担减轻。
根据本发明的刺扎系统可包括带盒(该带盒带有在权利要求7中给出的特征)和刺扎器械,带盒被置入该刺扎器械中且在带盒的载体带的所有刺血针均被使用之后被更换。但是,根据本发明的刺扎系统同样可以实现为一次性的器械,在该一次性的器械中不设置载体带的更换,并且,一旦布置在刺扎器械中的载体带的所有刺血针均被使用之后,该一次性的器械被清除。
本发明进一步的细节和有利之处将借助于实施例参照附图进行说明。此处,相同的和彼此相应的部件利用一致的参考标号表示。在实施例的范围内所描述的特征可单独地或者组合地构成权利要求的对象。其中:
图1显示了壳体打开时的根据本发明的刺扎系统的一个实施例;
图2显示了带引导的示意图;
图3显示了根据本发明的带盒的一种实施例的示意图;
图4显示了用于使用显示在图3中的带盒的刺扎器械的一种实施例;
图5显示了在图3中显示的带盒的带出口的示意图;以及
图6显示了在图3中显示的带盒的带入口的示意图。
图1显示了器械壳体打开时的刺扎系统的实施例,该刺扎系统带有载体带1,该载体带1承载着多个横向于其纵向方向而取向的刺血针2。带有未使用的刺血针2的载体带1卷绕到第一绕卷辊3上。已使用的刺血针2的载体带截段卷绕到第二绕卷辊4上。第二绕卷辊4被绕卷驱动器驱动,该绕卷驱动器在所显示的实施例中构造成自器械壳体5凸出的驱动轮6。通过第二绕卷辊4的转动,由载体带1承载的刺血针2依次被带到使用位置(Gebrauchsposition)中,其中,载体带1自第一绕卷辊3上解绕并卷绕到第二绕卷辊4上。在使用位置中,刺血针2可利用刺扎驱动器7为了穿刺而被加速,以便在贴靠到器械开口8上的身体部分中产生用于获得体液样品的穿刺伤口。
刺血针驱动器7包括驱动头9,该驱动头9具有切口(Schlitz),载体带1保持在该切口中。驱动头9通过连杆(Pleuelstange)10被驱动,该连杆10与转子11相联接,该转子11被驱动弹簧12驱动,该驱动弹簧12优选地构造成螺旋弹簧。驱动弹簧12可通过驱动轮6的操作被拉紧,该驱动轮6同时用于带输送。触发元件13(优选地为按键)用于触发穿刺运动。
载体带1在两个绕卷辊3,4之间在两个带引导元件14上被引导,使用位置位于两个带引导元件14之间。带引导元件14实现为偏转件(Umlenkungen)。该偏转件可构造成销或壳体棱边。偏转件优选地为辊子,该辊子(例如)可实现为可转动地安装到销上的套筒。带引导元件14同样可以(例如)实现为简单的销。辊子具有以下有利之处,即,实现带有较小的摩擦的带输送。
所显示的刺扎系统的一个特点在于,第一和第二绕卷辊之间的载体带1仅仅沿着一个转动方向地扭转。载体带1在两个绕卷辊3,4之间总计扭转二分之一转。使用位置(在该使用位置中,刺血针2可被使用以用于穿刺到贴靠到壳体开口8处的身体部分中)位于扭转了二分之一转的带截段中,其中,载体带1在使用位置的两侧上分别扭转四分之一转。利用第一绕卷辊3与使用位置之间的第一个四分之一转,载体带1被带到这样的取向中,在该取向中,由带1承载的刺血针2置放成横向于、优选地垂直于第一绕卷辊3的几何转动轴线。
在所显示的实施例中,刺血针2相对于载体带1的纵向方向沿横向布置并因此在第一个四分之一转之后沿着穿刺方向而定向。
在第二个四分之一转(该第二个四分之一转具有与第一个四分之一转相同的转动方向)中,刺血针2重新直立,使得其沿着、优选地平行于第二绕卷辊4的几何转动轴线而延伸。两个绕卷辊3,4的几何转动轴线优选为平行的,尽管同样可具有与此不同的取向。
通过使载体带1仅仅沿着一个转动方向地扭转,除了两个前面所提到的带引导元件14之外不需要其它带引导元件。尤其地,不需要额外的带引导元件以用于在使用位置与两个绕卷辊3,4之间产生该四分之一转。所显示的刺扎系统因此可实现尤其低摩擦的带输送。
两个带引导元件14之间的载体带1的扭转在图2中利用与穿刺方向相反的观察方向示意地示出。
图3显示了用于在刺扎器械30(例如在图4中所显示的)中使用的带盒20的一个实施例的示意图。
带盒20具有壳体21,在该壳体21中布置有载体带1,该载体带1承载着多个刺血针2,该刺血针2优选地相对于带1的纵向方向沿横向布置。与在图1中所显示的实施例中的相类似,载体带1在带盒20中卷绕到第一绕卷辊上,通过第二绕卷辊的转动,载体带1自该第一绕卷辊解绕并卷绕到第二绕卷辊上(在图中未示出)。与在图1中所显示的刺扎系统一样,在图3中所显示的带盒20的载体带1仅仅沿着一个转动方向地扭转,优选地扭转二分之一转。
载体带1经由出口22从带盒20的壳体21中离开并经由入口23重新进入壳体21中。载体带1在出口22与入口23之间扭转二分之一转。
除了刺血针2之外,在图3中所显示的实施例的载体带1还承载着测试区24,用于检测通过刺血针穿刺所获得的体液样品。该测试区24具有指示试剂,该指示试剂实现分析物浓度(例如葡萄糖浓度)的光度测定或电化学测定。合适的测试区存在于市场上可买到的例如用于血糖测定的测试带中且因此不需要进一步的说明。测试区24优选地布置在刺血针2之间。
图4显示了刺扎器械30的实施例,带盒20可为了使用而插入该刺扎器械30中。刺扎器械30具有用于带盒20的容纳舱(未示出)。容纳舱具有可被封闭的开口,该开口位于显示在图4中的实施例的背侧。
刺扎器械30具有器械开口31,身体部分可抵靠着该器械开口31而被按压以用于产生穿刺伤口。刺扎器械30还具有操作元件32(例如按键)和显示装置33(例如液晶显示器)。
所显示的刺扎器械30包括绕卷驱动器,以便使被置入的带盒20的第二绕卷辊转动,并由此将由载体带1承载的刺血针2和测试区24依次带到使用位置中。绕卷驱动器与在刺扎器械30中所包含的刺扎驱动器一样优选地为电池驱动的。刺扎驱动器此外可与在图1中所显示的实施例的刺扎驱动器一样地构造,其中,电马达用于拉紧驱动弹簧。
刺扎驱动器不仅使处于使用位置中的刺血针2加速以用于穿刺,而且还使处于使用位置中的测试区24沿着穿刺方向加速以用于样品接收运动。
所显示的刺扎器械30优选地还包括测量装置,以便测量利用测试区24及所接收的体液样品所进行的指示反应的结果,以使得可确定分析物浓度。
带有指示试剂的测试区(如存在于图3中所显示的实施例的载体带上的那些)通常对湿气敏感。为了保护载体带1的测试区24免受湿气及其它有害的环境影响,带盒20的带出口22及带入口23可各自设有通行密封件(Durchzugsdichtung)。合适的通行密封件的实例在图5和图6中示出。
由于该二分之一转(载体带1在带出口22与带入口23之间扭转该二分之一转),由带承载的测试区24在穿过壳体时(例如在带离开时)面向带盒20并在另一次穿过壳体时(例如在带进入时)背对带盒20。
在所描述的实施例中,测试区24在带离开时根据图5而取向并在带进入时根据图6而取向。即,在离开带盒20的壳体21之后,测试区24首先面向带盒,并在该二分之一转之后背对壳体21。然而,其原则上也可以相反。
在图5中所显示的通行密封件由覆盖出口22的膜(Folie)25及固定在其处的密封唇26形成。带利用一个带侧面贴靠在壳体21处并利用另一个带侧面贴靠在密封唇26处。为了使带输送变容易,壳体21在出口22的边缘处具有削角27。测试区24可以较小的摩擦阻力滑过壳体21的斜面27。
密封唇26由软塑性材料(例如泡沫塑料)制成且仅按压到平的带侧面上,因为测试区24位于相对的带侧面上。因此,尽管密封唇26较软并且可压缩,其仅引起较小的摩擦阻力。
在带入口23中,密封唇26相反地固定在壳体21处,使得带1在膜25与密封唇26之间被引导穿过。这样避免了软的密封唇26在由测试区24及刺血针2所形成的不平处被绊住。
通过将第一绕卷辊(载体带1的未使用的截段围绕该第一绕卷辊而绕卷)布置在相对于带入口23密封的室中,可以有利的方式省去带入口23的通行密封件,这是优选的。那么,带盒20优选地包括两个单独的室,在其中各布置有该两个绕卷辊中的一个。未使用的测试区24可在带盒20中额外地通过干燥剂而被保护。
参考标号列表
1载体带
2刺血针
3第一绕卷辊
4第二绕卷辊
5器械壳体
6驱动轮
7刺扎驱动器
8器械开口
9驱动头
10连杆
11转子
12驱动弹簧
13触发元件
14带引导元件
20带盒
21壳体
22出口
23入口
24测试区
25膜
26密封唇
27削角
30刺扎器械
31器械开口
32操作元件
33显示装置

Claims (10)

1.一种刺扎系统,其带有:
载体带(1),所述载体带(1)承载着多个刺血针(2),
第一绕卷辊(3),带有未使用的刺血针(2)的载体带(1)卷绕到所述第一绕卷辊(3)上,
第二绕卷辊(4),用于卷绕已使用的刺血针(2)的载体带截段,
绕卷驱动器(6),用于通过所述第二绕卷辊(4)的转动将由所述载体带(1)所承载的刺血针(2)依次带到使用位置中并在此自所述第一绕卷辊(3)上解绕所述载体带(1)和将所述载体带(1)卷绕到所述第二绕卷辊(4)上,
刺扎驱动器(7),用于使处于所述使用位置的刺血针(2)为了穿刺而加速,
其特征在于,所述载体带(1)在所述第一与所述第二绕卷辊(3,4)之间仅仅沿着一个转动方向地扭转至少一个四分之一转,优选地扭转至少一个二分之一转。
2.根据权利要求1所述的刺扎系统,其特征在于,所述使用位置位于已经扭转了所述二分之一转的带截段中,使得所述载体带(1)在所述使用位置的两侧上各扭转四分之一转。
3.根据前述权利要求中任一项所述的刺扎系统,其特征在于,所述载体带(1)在所述两个绕卷辊(3,4)之间在至少一个、优选两个偏转件(14)上被引导。
4.根据权利要求3所述的刺扎系统,其特征在于,所述载体带(1)在两个偏转件(14)之间扭转所述二分之一转。
5.根据前述权利要求中任一项所述的刺扎系统,其特征在于,所述绕卷驱动器(6)和所述刺扎驱动器(7)为刺扎器械(30)的一部分,带盒(20)可被置入所述刺扎器械(30)中,所述带盒(20)包括所述载体带(1)以及所述两个绕卷辊(3,4)。
6.根据前述权利要求中任一项所述的刺扎系统,其特征在于,所述刺血针(2)横向于所述载体带(1)的纵向方向而布置。
7.一种用于在刺扎器械(30)中使用的带盒,其带有
载体带(1),所述载体带(1)承载着多个刺血针(2),
第一绕卷辊(3),所述载体带(1)卷绕到所述第一绕卷辊(3)上,以及
第二绕卷辊(4),其中,所述载体带(1)通过所述第二绕卷辊(4)的转动可自所述第一绕卷辊(3)上解绕并可卷绕到所述第二绕卷辊(4)上,其特征在于,所述载体带(1)在所述第一与所述第二绕卷辊(3,4)之间仅仅沿着一个转动方向地扭转至少一个四分之一转,优选地扭转至少一个二分之一转。
8.根据权利要求7所述的带盒,其特征在于,除了所述刺血针(2)之外,所述载体带(1)还承载着用于检测体液样品的测试区(24)。
9.根据权利要求7或8所述的带盒,其特征在于出口(22)和入口(23),所述载体带(1)经由所述出口(22)从所述带盒(20)的壳体(21)离开,并且所述载体带(1)经由所述入口(23)重新进入所述带盒(20)的壳体(21)中,其中,所述载体带(1)在所述出口(22)与所述入口(23)之间扭转二分之一转。
10.根据权利要求9所述的带盒,其特征在于,所述出口(22)设有通行密封件,在该通行密封件处,所述载体带(1)在所述带盒(20)的壳体(21)与固定在覆盖所述出口(22)的膜(25)处的密封唇(26)之间被引导穿过。
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