CN106620946B - 延伸管应变消除 - Google Patents

延伸管应变消除 Download PDF

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CN106620946B
CN106620946B CN201610970390.4A CN201610970390A CN106620946B CN 106620946 B CN106620946 B CN 106620946B CN 201610970390 A CN201610970390 A CN 201610970390A CN 106620946 B CN106620946 B CN 106620946B
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extension
access device
adapter
vascular access
extension tube
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CN106620946A (zh
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B·D·彼得森
J·K·伯克霍兹
B·F·比尔迈尔
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Becton Dickinson and Co
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    • A61M25/0625Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism
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    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
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    • F16LPIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
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Abstract

一种一体化的脉管通路装置,其可以包括应变消除特征部以使延伸管在使用期间变得扭结的可能性最小化。应变消除特征部可以在延伸管的两端被配置成使在通向导管适配器和鲁尔适配器的接口处的扭结可能性最小化。为了在延伸管的导管适配器端处提供应变消除,由柔性材料形成的接口可以与导管适配器的延伸部对准,延伸管插入于导管适配器的延伸部内。接口可以一体化到稳定平台内或者与稳定平台分开地形成。为了在延伸管的鲁尔适配器端处提供应变消除,柔性间隔件可以联接到适配器的远端并且具有绕延伸管定位的远端部。

Description

延伸管应变消除
相关申请
本申请要求保护以下申请的权益:在2015年10月28日提交的美国临时专利申请No.62/247,624;在2015年10月28日提交的美国临时专利申请No.62/247,596;在2016年2月17日提交的美国临时专利申请No.62/296,383;在2015年10月28日提交的美国临时专利申请No.:62/247,599;在2015年10月28日提交的美国临时专利申请No.62/247,617;在2015年10月28日提交的美国临时专利申请No.62/247,607;在2015年10月28日提交的美国临时专利申请No.62/247,621;在2015年10月28日提交的美国临时专利申请No.62/247,626;以及在2016年2月17日提交的美国临时专利申请No.62/296,385;其中的每一个的全文以引用的方式并入到本文中。
背景技术
当脉管通路装置被确定为“闭合的”或“一体化的”时,其通常指该装置被配置成在插入导管期间防止血液从该装置出来。通常,这种IV通路装置通过将延伸部套件与导管适配器一体化而实现这点。
图1示出了现有技术闭合脉管通路装置100的一个示例。装置100包括:导管适配器101,导管101a从导管适配器101延伸;针毂102,针102a从针毂102延伸;延伸管103,其在一端联接到导管适配器101并且包括联接到另一端的Y形适配器104;以及,夹具107,其用来阻挡或限制流体通过延伸管103流动。Y形适配器104包括端口105和通气塞106。尽管示出了Y形适配器,但可以使用任何类型的鲁尔适配器。装置100可以是闭合的系统,将流体流动阻挡部件(例如,隔膜或通气孔)并入到该装置的每个外部开口内,诸如并入到导管适配器101的近端内和适配器104中的任何端口内。
导管适配器101包括稳定平台,稳定平台包括第一侧101b和第二侧101c。导管适配器101还包括延伸部101d,延伸部101d从导管适配器101的主体部101e延伸。通路装置100可以被称作“一体化的”,因为延伸管103的一端插入于并且固定于延伸部101d内,使得延伸管103经由导管适配器101的管腔而流体地联接到导管101a。
在通路装置100中,延伸管103可能在延伸管103与延伸部101d之间的接口处扭结。同样,延伸管103也可能在延伸管103与鲁尔适配器104之间的接口处扭结。
发明内容
本发明总体而言针对于一种一体化的脉管通路装置,其包括应变消除特征部,以减小延伸管在使用期间变得扭结的可能性。应变消除特征部可以在延伸管的两端配置,使得在通向导管适配器和鲁尔适配器的接口处扭结的可能性最小化。
为了在延伸管的导管适配器端处提供应变消除,延伸管所插入的导管适配器的延伸部可以一体化到稳定平台的侧部内。本发明的各种部件和/或表面可以包括柔软的柔性材料,以辅助使用者握持部件和/或向所希望的部件提供应变消除。在某些实施例中,柔性材料包括柔软的聚合物,柔软的聚合物具有大约30肖氏A至大约90肖氏D的计示硬度。在某些实施例中,柔性材料包括具有大约50肖氏A至大约90肖氏D的计示硬度的柔软聚合物。
在某些实施例中,稳定平台由柔性材料形成。这种柔性材料也可以用来形成延伸部的端部。以此方式,允许形成延伸管与导管适配器之间的接口的延伸部的端部挠曲,以使延伸管的扭结可能性最小化。作为替代,这个接口可以与稳定平台分开地形成,包括在其中导管可以包括或可以不包括稳定平台的实施例中。
为了在延伸管的鲁尔适配器端处提供应变消除,包括柔性材料的间隔件可以定位于延伸管周围并且联接到鲁尔适配器的一端。因此柔性间隔件在延伸管与鲁尔适配器之间的接口处提供加强并且可以挠曲,以使扭结可能性最小化。在某些实施例中,柔性间隔件的尺寸也可以被设计为使之能够防止夹具延伸到鲁尔适配器的刚性部分上或与该刚醒部分相接触。这进一步使得由于夹具抵靠鲁尔适配器弯曲而造成扭结的可能性被最小化。
在一实施例中,本发明实施为一种脉管通路装置,其包括:导管适配器,其包括主体部和延伸部,导管从主体部向远端延伸,延伸部从主体部向外延伸;延伸管,其具有插入于延伸部内并且固定于延伸部内的远端;以及,接口,其由柔性材料形成,定位成与延伸部配准(in line),使得延伸管穿过接口延伸到延伸部内。
在另一实施例中,本发明实施为一种脉管通路装置,其包括:导管适配器;适配器;延伸管,其具有远端和近端,远端联接到导管适配器,近端联接到适配器;以及,柔性间隔件,其具有近端部和远端部,近端部联接到适配器的远端,远端部定位于延伸管的周围。
在另一实施例中,本发明实施为一种脉管通路装置,其包括:导管适配器,其包括主体部和延伸部,导管从主体部向远端延伸,延伸部从主体部向外延伸;延伸管,其具有插入于延伸部内并且固定于延伸部内的远端;适配器,其联接到延伸管的近端;以及,第一应变消除特征部和第二应变消除特征部,第一应变消除特征部形成于延伸管的导管适配器端并且第二应变消除特征部形成于延伸管的适配器端处。第一应变消除特征部和第二应变消除特征部是下列之一:由柔性材料形成的接口,其定位成与延伸部或者适配器的远端配准,使得延伸管穿过接口延伸到延伸部或者适配器的远端内;或者,柔性间隔件,其具有第一端和第二端,第一端联接到延伸部或者适配器的远端,第二端绕延伸管定位。
本发明的这些和其它特征和优点可以合并到本发明的某些实施例内并且将从下面的描述和所附权利要求将变得更加显明,或者可以通过对如下文所陈述的本发明加以实践而领会。本发明并不需要本文所描述的所有有利特征和所有优点都合并到本发明的每个实施例中。
附图说明
为了使获得本发明的上述和其它特征和优点的方式易于理解,将参考在附图中示出的本发明的具体实施例来得到在上文中简要描述的本发明的更特定描述。这些附图仅描绘了本发明的典型实施例,并且因此并非用以限制本发明的范围。
图1示出了一种现有技术IV通路装置。
图2示出了根据本发明的一个或更多个实施例配置的脉管通路装置。
图3示出了图2中示出的脉管通路装置的导管适配器。
图4提供了图3中示出的导管适配器的截面图。
图5提供了图2所示的脉管通路装置的鲁尔适配器的一实施例的截面图。
图6提供了图2所示的脉管通路装置的鲁尔适配器的一实施例的截面图。
具体实施方式
图2示出了根据本发明的一个或更多个实施例配置的脉管通路装置200的示例。通路装置200包括:导管适配器201,导管201a从导管适配器201向远端延伸;针毂202,针202a从针毂202向远端延伸;延伸管203,其具有联接到导管适配器201的远端203a和联接到适配器204的近端203b;以及,夹具205,其用来限制流体通过延伸管203流动。适配器204通常可以是鲁尔适配器,鲁尔适配器被配置成允许其它通路装置联接到通路装置200。
导管适配器201可以包括由侧部201b和201c形成的稳定平台,侧部201b和201c从导管适配器201的相对两侧向外延伸。如图2所示,在某些实施例中,通路装置200被配置成由右手使用,因为延伸管203联接到导管适配器201的左侧使得稳定平台侧201b完全暴露。这可以有利于使用右手的拇指来握持稳定平台侧201b。当然,在被设计成由左手使用的通路装置中,稳定平台侧201b、201c和延伸管203将在导管适配器201的与图2所示侧部相对的一侧上。
针毂202包括桨式握持部202b,桨式握持部202b从针毂202的右侧向外延伸并且形状大体上对应于稳定平台侧201b的形状。因此,桨式握持部202b可以定位于稳定平台侧201b的正下方使得在插入导管201a期间稳定平台侧201b和桨式握持部202b可以夹在临床医生的拇指与食指之间。通过以此方式配置桨式握持部302n,临床医生能通过简单地使食指相对于拇指向后滑动从而造成桨式握持部202b远离稳定平台侧201b向后滑动而容易地从导管适配器201抽出针毂202。
针毂202还包括回流腔室210,回流腔室210联接到针毂202的近端。回流腔室210可以包括插塞210a,插塞210a允许空气通过针毂202中的近端开口逸出同时防止血液离开。而且,针202a的近端能伸入到回流腔室210内并且可以包括开口,以允许血液从针202a流出到回流腔室210内。
根据本发明的一些实施例并且如图3和图4所示,导管适配器201的主体部201e可以包括延伸部201d,延伸部201d一体化到稳定平台侧201c内。延伸部201d可以被配置成接纳并且固定延伸管203的远端203a。主体部201e和延伸部201d二者可以由相同材料模制而成。
稳定平台侧201c可以绕延伸部201d形成(例如,绕延伸部201模制)使得产生绕延伸管203的接口201c1。接口201c1可以(但并非必需地)由与稳定平台侧201c相同的材料形成,这种材料比用来形成主体部201e和延伸部201d的材料更柔软。在形成后,接口201c1可以充当延伸部201d的端部。换言之,延伸部201d和接口201c1的组合可以形成连续结构,延伸管203的远端203a穿过该连续结构延伸。本领域技术人员将意识到接口201c1可以合并到包括一体化延伸管和相应延伸部的任何兼容的导管适配器的任何稳定平台内。例如,在一实施例中,接口201c1可以合并到图1的现有装置100的延伸部101d内或上。
因为接口201c1由比延伸部201d更柔软的材料形成,在延伸管203与延伸部201d之间的接口处不太可能发生扭结。具体地说,延伸管203可以由基本上柔性的材料形成以允许适配器204相对于导管适配器201定位于任何合适位置。接口201c1(以及稳定平台侧201c)的柔性可以小于延伸管203但是柔性大于延伸部201d,使得在接口201c1内的延伸管203的部分能在某种程度上弯曲,但是不足以形成扭结。这种柔性转变显著地降低延伸管203扭结的可能性。
图4提供了导管适配器201的截面图。在此图中,沿着在稳定平台侧201b和201c的顶表面略上方并且穿过主体部201e和延伸部201d延伸的平面截取该截面。如图所示,主体部201e和延伸部201d可以模制为单个部件。稳定平台侧201b、稳定平台侧201c和接口201c1也可以模制为绕导管适配器201的单个部件。作为替代,稳定平台侧201c和接口201c1可以模制为与稳定平台侧201b分开的单个部件。在任一情况下,接口201c1是稳定平台侧201c的一体化部分,其形成套筒状结构,延伸管203c穿过该套筒状结构而延伸。图4还示出了延伸管203的远端203a插入于延伸部201d内,使得其固定到导管适配器201上。延伸部201d和接口201c1因此能形成连续管腔,延伸管203通过连续管腔插入。
在另一些实施例中,接口201c1可以独立于稳定平台而形成。例如,接口201c1能绕延伸部201d或抵靠延伸部201d模制,独立于稳定平台侧201b(例如,在稳定平台侧201b上方)。作为替代,接口201c1可以绕不包括稳定平台或者仅在导管适配器的相对侧上包括仅一个稳定平台侧(例如,仅稳定平台侧201b)的导管适配器上的延伸部201d或者抵靠该延伸部201d模制。
应当指出的是针毂202在图3和图4中并未示出。而且,导管适配器201通常可以包括隔膜,隔膜(未图示)定位于延伸部201d近端以防止血液或流体通过导管适配器201的近端开口向近端流出。延伸部201d被示出并不延伸到达或超过稳定平台侧201c的边缘。然而,在某些实施例中,延伸部201d可以延伸比图3和图4所示的情形更远。例如,延伸部201d可以延伸到达甚至超过稳定平台侧201c的边缘。在这种情况下,接口201c1可以被配置成包封延伸部201d的一部分以及以图3和图4所示的方式延伸超过延伸部201d的边缘。
图5和图6示出了包括柔性间隔件206的鲁尔适配器204的实施例的截面图。如图所示,延伸管203的近端203b延伸到并且固定于鲁尔适配器204内。柔性间隔件206具有套筒形状,套筒形状的内部直径足以允许柔性间隔件206绕延伸管203布置。柔性间隔件206也可以具有充分的弹性,以允许近端部206b绕鲁尔适配器204的远端布置。在近端部206b绕鲁尔适配器204布置的情况下,柔性间隔件206将固定到鲁尔适配器204,其中,远端部206a绕延伸管203定位。远端部206a能在鲁尔适配器204与延伸管203之间的接口处提供加强,从而使延伸管203在接口处变得扭结的可能性得以最小化。
在诸如图5和图6所述的某些实施例中,鲁尔适配器204的远端开口可以包括倒角表面204a。倒角表面204a允许延伸管203在接触鲁尔适配器204的远端边缘之前略微弯曲。如图6所示,在某些实施例中,柔性间隔件206的内部直径可以大于延伸管203的外部直径并且大致等于在倒角表面204a的最远端点处的直径。在这些情况下,空间206a1将存在于延伸管203与远端部206a之间。
柔性间隔件206可以是与延伸管203和鲁尔适配器204分开的单独部件。作为单独部件,柔性间隔件206可以由不同于用来形成鲁尔适配器204的材料的合适弹性材料形成。在某些实施例中,柔性间隔件206的外部直径可以大于夹具205中的通道或开口(延伸管203通过该通道或开口而延伸)的内部直径。以此方式,柔性间隔件206可以用来防止夹具205定位成过于靠近鲁尔适配器204。具体地说,如果夹具205将延伸管203夹持在延伸管203与鲁尔适配器206之间的接口处,这将造成延伸管203在其抵靠鲁尔适配器204的远端弯曲时在接口处更可能扭结。柔性间隔件206也可以用来确保夹具205并不能在接口附近夹持延伸管203。
尽管上文的描述说明了仅在延伸管的导管适配器端处形成接口201c1并且说明了仅在延伸管的鲁尔适配器端并入柔性间隔件206,这些技术可以适用于延伸管的相对端。例如,类似于接口201c1的接口可以绕延伸管203形成于鲁尔适配器204的远端上代替柔性间隔件206。这可以通过绕鲁尔适配器204的远端利用柔性材料单独地模制接口而实现(例如,参考附图,延伸部201d可以被视作鲁尔适配器204的远端)。作为替代,在其中鲁尔适配器204包括由柔性材料模制而成的部件的实施例中,接口可以一体地形成于部件内,以与接口201c1一体地形成于稳定平台侧201c内相似的方式。例如,如果鲁尔适配器204包括柔软握持特征,这种柔软握持特征可以延伸以在鲁尔适配器204的远端处形成接口。
同样,柔性间隔件可以用于延伸管的导管适配器端以代替接口201c1。这可以通过绕延伸部201d布置柔性间隔件(或者以其它方式固定到柔性间隔件)而实现。在这种情况下,延伸部201d可以被配置成具有倒角,类似于图5和图6所示的情形。如上文所描述,柔性间隔件可以以此方式用于包括延伸部201d的任何配置的导管适配器中,包括具有或不具有稳定平台的导管适配器。
本发明的各种实施例还包括安全机构,安全机构被配置成在从导管适配器移除和分离了针毂之后固定引入针的尖锐远顶端。安全机构可以包括本领域中任何兼容的装置。在某些情形下,安全机构被配置成与针特征诸如套圈、缺口、套管上的卷边或突起相互作用。在套管中形成的卷边或突起造成略微不圆的配置,这种略微不圆的配置可以用来启动安全机构。在某些情形下,安全机构包括臂或杠杆,臂或杠杆被致动以在该机构内俘获针尖,并且防止针尖在安全处理之前出来。
安全机构附连到针主体上并且能够沿着其长度滑动。在某些情形下,在插管之前,安全机构的初始或组装位置靠近导管适配器的基座或近端而定位。对于某些配置,安全机构的组装位置在针毂的近端与导管适配器或稳定平台的近端之间,其中,安全机构并不与导管适配器或稳定平台重叠。在某些情形下,安全机构的一部分定位于导管适配器内,安全机构的其余部分定位于导管适配器的外部,诸如在针毂内。在某些实施例中,导管适配器或稳定平台的一部分向近端延伸以提供外壳,安全机构的至少一部分容纳于外壳内。在某些情形中,在插管之前,整个安全机构容纳于导管适配器或稳定平台的外壳内。
在某些实施例中,安全机构的组装位置将导管适配器的近端定位于安全机构的远端与针毂的桨式握持部的远端之间。在某些情形中,安全机构的组装位置使导管适配器的近端定位于安全机构的远端与针毂的桨式握持部的近端之间。在某些情形下,安全机构的一部分与针毂的桨式握持部的一部分重叠。在某些实施例中,导管适配器和桨式握持部中至少一个的至少某些部分与安全机构的至少某些部分重叠。在某些实施例中,并无导管适配器或桨式握持部的部分与安全机构的任何部分重叠。
在某些实施例中,可脱开的机械连接提供于安全机构与通路装置的至少一个其它部件之间。在某些实施例中,安全机构的远端选择性地联接到导管适配器的近端。在一实施例中,安全机构在内部联锁到导管适配器的近端。在一些实施例中,安全机构联接到导管适配器的近端。在某些实施例中,安全机构的远端选择性地联接到稳定平台的近端。在某些实施例中,安全机构的表面选择性地联接到导管适配器、血液控制阀、延伸管和稳定平台的至少一个的至少一个表面上。在某些情形中,在将针尖固定于安全机构内时,机械连接脱开。
本发明可以以其它具体形式来实施,而不偏离如本文和所附权利要求中广泛描述的其结构、方法或其它基本特征。所描述的实施例在所有方面认为只是说明性的而不是限制性的。因此本发明的范围由所附权利要求而不是由前文的描述限制。属于权利要求的等效物的意义和范围内的所有变化涵盖于本发明的范围内。

Claims (20)

1.一种脉管通路装置,所述脉管通路装置包括:
导管适配器,其包括主体部、延伸部和导管,其中,所述主体部包括近端以及与所述近端对准的远端,其中,所述导管从所述远端向远侧延伸,其中,所述延伸部从所述主体部向外延伸并且设置在所述近端和所述远端之间,其中,所述延伸部由第一材料构造;
稳定平台,所述稳定平台从所述导管适配器向外延伸,其中,所述稳定平台包括翼片;
延伸管,所述延伸管具有的远端插入于所述延伸部内并且固定于所述延伸部内;以及
接合到延伸部的最近侧表面的接口,其由第二材料形成,其中,所述第二材料比所述第一材料更柔软,其中,所述延伸管穿过所述接口延伸并且位于所述接口的近侧,其中,所述接口是所述稳定平台的一体化部分。
2.根据权利要求1所述的脉管通路装置,其中:
所述稳定平台具有第一稳定平台侧,所述第一稳定平台侧联接到所述导管适配器并且从所述主体部向外延伸。
3.根据权利要求2所述的脉管通路装置,其中,所述接口是所述第一稳定平台侧的一体化部分。
4.根据权利要求2所述的脉管通路装置,其中,所述第一稳定平台侧绕所述延伸部的一部分模制。
5.根据权利要求1所述的脉管通路装置,其中,所述接口:
绕所述延伸部的一部分延伸;或者
模制到所述延伸部。
6.根据权利要求2所述的脉管通路装置,其中,所述第一稳定平台侧和所述延伸部由相同柔性材料形成。
7.根据权利要求2所述的脉管通路装置,其中,所述第一稳定平台侧从所述主体部延伸得比所述延伸部更远。
8.根据权利要求1所述的脉管通路装置,还包括:
适配器,其联接到所述延伸管的近端;以及
柔性间隔件,其具有近端部和远端部,所述近端部联接到所述适配器的远端,所述远端部定位于所述延伸管的周围。
9.根据权利要求8所述的脉管通路装置,其中,所述柔性间隔件是与所述适配器分开的单独部件。
10.根据权利要求8所述的脉管通路装置,其中,所述适配器的远端开口包括倒角表面。
11.根据权利要求10所述的脉管通路装置,其中,所述柔性间隔件的内部直径大致等于在所述倒角表面的最远端部处的直径。
12.根据权利要求8所述的脉管通路装置,还包括:
夹具,其具有开口,所述延伸管穿过所述开口延伸以将所述夹具固定到所述延伸管上,所述开口具有直径,并且其中,所述柔性间隔件的外部直径大于所述开口的直径,以防止所述夹具延伸到所述柔性间隔件上。
13.一种脉管通路装置,所述脉管通路装置包括:
导管适配器;
鲁尔适配器,其包括倒角表面;
延伸管,其具有远端和近端,所述远端联接到所述导管适配器,所述近端联接到所述鲁尔适配器;以及
柔性间隔件,其具有近端部和远端部,所述近端部联接到所述鲁尔适配器的远端,所述远端部定位于所述延伸管的周围,其中,所述鲁尔适配器设置在所述柔性间隔件的近端部和所述延伸管之间,其中,所述柔性间隔件的远端部与所述延伸管间隔开以形成空间,其中,所述鲁尔适配器的倒角表面靠近所述空间。
14.根据权利要求13所述的脉管通路装置,其中,所述鲁尔适配器的远端开口包括所述倒角表面。
15.根据权利要求14所述的脉管通路装置,其中,所述柔性间隔件的近端部的内部直径大致等于所述鲁尔适配器的外部直径。
16.根据权利要求13所述的脉管通路装置,其中,导管适配器包括主体部和延伸部,导管从所述主体部延伸,所述延伸部从所述主体部向外延伸;所述延伸管的远端插入于所述延伸部内,所述脉管通路装置还包括:
由柔性材料形成的接口,其定位成与所述延伸部配准,使得所述延伸管穿过所述接口延伸到所述延伸部内。
17.根据权利要求16所述的脉管通路装置,其中,所述接口具有环绕所述延伸管的套筒形状。
18.根据权利要求16所述的脉管通路装置,还包括:
稳定平台,其具有第一稳定平台侧,所述第一稳定平台侧联接到所述导管适配器并且从所述主体部向外延伸,其中,所述接口是下列之一:
所述第一稳定平台侧的一体化部分;或者
与所述第一稳定平台侧分开的单独部分。
19.根据权利要求18所述的脉管通路装置,其中,所述接口延伸超过所述第一稳定平台侧的边缘。
20.一种脉管通路装置,所述脉管通路装置包括:
导管适配器,其包括主体部、延伸部和导管,其中,所述主体部包括近端以及与所述近端对齐的远端,其中,所述导管从所述远端向远侧延伸,其中,所述延伸部从所述主体部向外延伸并且设置在所述近端和所述远端之间,其中,所述延伸部由第一材料构成;
延伸管,其具有插入于所述延伸部内并且固定于所述延伸部内的远端;
鲁尔适配器,其联接到所述延伸管的近端,其中,所述鲁尔适配器包括倒角表面;
柔性间隔件,其具有近端部、远端部以及设置在所述近端部和所述远端部之间的过渡部,其中,所述近端部联接到所述鲁尔适配器的远端,所述远端部绕所述延伸管定位,其中,所述鲁尔适配器设置在所述柔性间隔件的近端部和所述延伸管之间,其中,所述近端部包括第一内部直径,其中,所述远端部包括第二内部直径,其中,所述第一内部直径大于所述第二内部直径,其中,所述柔性间隔件的远端部的第二内部直径大致等于所述延伸管的外部直径。
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