CN115003360A - 静脉内导管装置 - Google Patents
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Abstract
一种静脉内导管装置(100),包括导管套(102)、阀瓣构件(158)、致动器构件(176)和阀瓣闭合构件(192)。阀瓣构件(158)包括凸形部分(162),该凸形部分设置有限定分支部(172)的狭缝(170)。这些狭缝(170)构造成当针头(116)刺入狭缝(170)时张开以使针头刺穿患者的血管。阀瓣闭合构件(192)设置在导管套(102)内部,使得阀瓣闭合构件(192)的第一表面(194)邻接阀瓣构件(158)的凸形部分(162)。当邻接位于导管套(102)内部的致动器构件(176)的鲁尔锁定构件(206)脱离时,阀瓣闭合构件(192)适于推动分支部(172),从而闭合用于流体流动的通道(204)并防止来自患者的被刺穿的血管的血液流出。
Description
技术领域
本公开涉及医学装置。更具体地,本公开涉及一种防止血液回流的静脉内导管装置。
背景技术
导管自古以来已被人类使用。古叙利亚人用芦苇制造导管。古希腊人使用穿过尿道***到患者的膀胱中的中空金属管来排空膀胱。在现代医学中,N.B.Sornborger医生于1868年申请的注射器和导管的专利中首次描述了导管的使用。
静脉内(IV)导管也已存在很多年。静脉内导管是用于将药物或流体直接注入到血管中或抽取血液样本以用于测试的静脉装置。使用针头将静脉内导管引入到血管中并且用胶带将静脉内导管固定到患者的皮肤。
使用针头上静脉内导管的缺点是在将针头从导管中抽出后存在供血液流过导管并从导管套溢出的开放通道。血液可能被污染并且这可能导致医护人员感染的风险。此外,血液的溢出对于患者以及在应用导管的医疗空间中而言导致不卫生的状况,并且血液的溢出目前是IV导管管理期间的主要问题。
存在避免血液溢出的已知方法,但是这些方法包括与每个方法相关联的某些风险和缺点,其中一种方法是在抽出针头之前在血管上施加手动压力以停止血液流动,但是这种方法需要具有专业技能的技术人员使用双手或可能需要两个操作者,并且这种方法仍然不能停止血液流动。使用封闭***静脉内导管来允许空气逸出以用于回流可视化并且允许注入流体,在封闭***静脉内导管中通过具有在血液流动的路径中的停滞止动件来使血液流动停止并且具有与导管成一角度设置的侧端口。然而,这些产品庞大、使用复杂并且比标准产品更昂贵。
在另一已知的方法中,导管空间可被心轴或闭塞器阻塞,使用该心轴或闭塞器需要适当的技能和训练,并且进一步使得产品在结构和操作上复杂且昂贵。
在美国专利第4,874,377号(下文称为专利'377)中公开了另一种已知的导管装置。专利'377描述了一种具有用于防止血液回流的阀瓣的导管套组件。当连接器附接到导管套时,利用压力使阀瓣变形,并且控制该变形以允许流体通过。设想为了允许专利'377中的变形,接头的直径和总尺寸将增加。虽然专利'377试图提供实际可能的解决方案,但是尺寸的增加实质上干扰产品的总体功能并且极大地影响患者舒适度。
在美国专利第5,064,416号(下文称为专利'416)中公开了又一种已知的导管装置。专利'416描述了一种具有平滑尖端的截头锥形致动器,该截头锥形致动器用鲁尔连接器来启用但在该连接器被移除时滑回。这种类型的移动充满实际问题,尤其对于保存期限长(例如,3年或更长)的装置而言。此外,专利'416没有描述阀瓣如何设计或安装到导管套中。
在美国专利第5,154,703号(下文称为专利'703)中公开了又一种已知的导管装置。专利'703描述了一种简单的盘形阀瓣,该阀瓣与尖锐的针头组合,该针头在与鲁尔连接器连接时刺穿该盘。在专利'703中添加尖锐的针头带来了许多安全相关的问题,其中包括产品的适当处理和处置。在小组件中组装小尺寸的尖锐的针头也是复杂的。
在美国专利第5,053,014号(下文称为专利'014)中公开了又一种已知的导管装置。专利'014描述了一种两部式导管套组件,利用过盈配合将膜***到该导管套组件中。然后,平滑的柱塞也被封在该两部式组件内,使得当应用鲁尔连接器时,该柱塞穿透膜。
在PCT专利公开第WO2017042825A2号(下文称为专利'825)中公开了又一种已知的导管装置。专利'825中的导管装置公开了具有多个狭缝的单向阀瓣,以用于在血管被针刺穿时防止血液的反向流动。
在PCT专利公开第WO2018096549A1号(下文称为专利'549)中公开了又一种已知的导管装置。在专利'549中的导管装置公开了具有多个狭缝的单向阀瓣,这些狭缝用于在血管如果被针刺穿时防止血液的反向流动。
然而,当用户想要关闭流体路径时,专利'825和专利'549中的单向阀瓣中的狭缝不完全关闭,并且单向阀瓣不会提供想要解决这些问题的完全解决方案。
尽管为防止血液回流提供了具有或不具有致动器的阀瓣的许多设计,但是这些阀瓣的设计是非常复杂的并且在制造、组装和产品性能方面包括相当大的挑战。
因此,本公开旨在克服如上所述的一个或多个问题。
发明内容
本公开的目的是提供一种静脉内导管以避免血液的反向流动。
本公开的另一目的是提供一种具有新颖的单向阀瓣设计的静脉内导管,该单向阀瓣设计负责防止血液的反向流动。
本公开的另一目的是提供一种用于防止血液反向流动的机构,该机构可应用于多种其他导管装置。
本发明涉及一种静脉内导管装置。该静脉内导管装置包括导管套,该导管套具有近端和远端、同轴凹部和底切部分,其中,该同轴凹部具有设置在导管套的近端处的环形止动件,底切部分朝向导管套的远端设置。静脉内导管装置还包括适于设置在导管套的同轴凹部内部的阀瓣构件。该阀瓣构件由柱形部分和设置在柱形部分的一端处的弯曲部分限定,一同轴凹部从柱形部分延伸到弯曲部分。弯曲部分设置有限定多个分支部的一个或多个狭缝。狭缝构造为允许针头穿过狭缝以刺穿患者的血管。静脉内导管装置还包括适于设置在导管套的近端处的回流腔室,其中,进入回流腔室的血流确认静脉被针头刺穿。静脉内导管装置还包括具有轴向孔的致动器构件。该致动器构件适于设置在阀瓣构件的同轴凹部内。当鲁尔锁定构件可移除地连接在导管套的邻接致动器构件的近端处时,致动器构件沿朝向导管套的远端的方向轴向地移位,由此使阀瓣构件的多个分支部张开以形成从导管套的近端到导管套的远端的用于流体流动的通道。静脉内导管装置还包括阀瓣闭合构件,该阀瓣闭合构件包括在近端处的第一表面、在远端处的第二表面以及在近端和远端之间延伸的通孔,该阀瓣闭合构件设置在导管套内部,使得阀瓣闭合构件的第一表面邻接导管套的底切部分,并且阀瓣闭合构件的第二表面邻接阀瓣构件的弯曲部分,其中,阀瓣闭合构件适于使阀瓣构件的多个分支部闭合,由此,当邻接致动器构件的鲁尔锁定构件被移除时,闭合用于流体流动的通道并防止从患者的被穿刺的血管流出的血液从导管套的远端流到导管套的近端。
在实施例中,阀瓣闭合构件的硬度在从约50肖氏硬度至约80肖氏硬度的范围内,并且阀瓣构件的硬度在从约20肖氏硬度至约45肖氏硬度的范围内。
在实施例中,阀瓣闭合构件的第一表面是凹形形状的或呈腔体形式的截头锥形形状的。
在实施例中,阀瓣构件的弯曲部分是凸形形状的或截头锥形形状的。
在实施例中,当阀瓣构件的第一端邻接导管套的环形止动件时,阀瓣构件适于在导管套的同轴凹部处保持就位。
在实施例中,阀瓣构件是由选自由硅树脂和橡胶组成的组中的柔性材料制成的。
在实施例中,狭缝为Y形、X形、+形或它们的组合。
在实施例中,阀瓣构件的柱形部分在内表面处具有突起部。
在实施例中,致动器构件具有在致动器构件的外表面处的圆形凹部,并且其中,阀瓣构件的突起部适于与致动器构件的圆形凹部接合,由此,将阀瓣构件和致动器构件的组件完整地置于导管套内部。
在实施例中,致动器构件包括具有径向延伸的凸缘的第一端、具有凸形表面的第二端以及在致动器构件的第一端与第二端之间的轴向孔。
在实施例中,阀瓣闭合构件的硬度比阀瓣构件的多个分支部的硬度大,当鲁尔锁定构件与导管套脱离时,阀瓣闭合构件沿远离导管套的远端的方向推动多个分支部和致动器构件,由此,闭合用于流体流动的通道并防止从患者的被穿刺的血管流出的血液从导管套的远端流到导管套的近端。
在实施例中,致动器构件是由刚性塑料材料或金属制成的。
在实施例中,回流腔室包括多孔过滤器和覆盖件中的任一者,以允许空气逸出且允许血液在回流腔室内部流动。
在实施例中,装置包括针刺安全装置。
附图说明
图1示出了根据本公开的示例性实施例的静脉内导管装置的立体图;
图2示出了图1所示的静脉内导管装置的截面图;
图3示出了静脉内导管装置的在图2中由部分“A”标出的导管套的放大图;
图4示出图1至图3所示的导管套的立体图;
图5a和图5b示出了图1至图4所示的根据本公开的示例性实施例的静脉内导管装置的致动器构件的立体图和截面图;
图6a至图6d示出了图1至图4中所示的根据本公开的示例性实施例的静脉内导管装置的阀瓣构件的立体图、截面图、前视图和后视图;
图7a至图7d示出了图1至图4中所示的根据本公开的示例性实施例的静脉内导管装置的阀瓣闭合构件的立体图、截面图、前视图和后视图。
图8示出了根据本公开的示例性实施例的静脉内导管装置的截面图,示出了当针头***到阀瓣构件中以用于刺穿血管时静脉内导管装置的操作;
图9示出了根据本公开示例性实施例的静脉内导管装置的截面图,示出了当鲁尔锁定构件可释放地连接至静脉内导管装置的近端时,鲁尔锁定构件的用于产生流体流动的通道的操作;
图10示出了图9所示的根据本公开的示例性实施例的静脉内导管装置在鲁尔锁定构件处于脱离位置中且用于流体流动的通道关闭时的截面图;
图11和图12示出了根据本公开的另一示例性实施例的静脉内导管装置的立体图和截面图;
图13示出了图11和图12所示的静脉内导管装置的导管套的立体图;
图14示出了根据本公开的又一示例性实施例的静脉内导管装置的立体图;
图15示出了图14所示的静脉内导管装置的截面图;
图16示出了图14和图15所示的静脉内导管装置的导管套的立体图;
图17示出了根据本公开的又一示例性实施例的静脉内导管装置的立体图;
图18示出了图17所示的静脉内导管装置的截面图;
图19示出了图17和图18所示的静脉内导管装置的导管套的立体图;以及
图20a和图20b示出了具有过滤器的回流腔室的立体图和截面图。
具体实施方式
以下提供的是本公开的非限制性示例性实施例,并且现在将详细参考具体实施例或特征,这些实施例的示例在附图中示出。只要可能,贯穿附图使用相应的或相似的参考标号指代相同的或相应的部分。此外,当可能存在超过一个相同类型的元件时,这些元件共同地或单独地参考本文所描述的各种元件。然而,这种参考本质上仅仅是示例性的。应当注意到,除非在所附权利要求中明确陈述,否则以单数形式对元件的任何引用也可以被解释为涉及复数,并且反之亦然,而不将本公开的范围限制于此类元件的确切数目或类型。
图1和图2分别示出了根据本公开的示例性实施例的导管装置(100)的立体图和截面图。该导管装置(100)是用于经历治疗的患者身上的医学装置,以用于通过静脉内的治疗来管理药物流体,或者,导管装置(100)可用于基于导管的类型来实施其他任务。在所示的附图中,导管装置(100)是静脉内导管装置。如在本公开中所提及的术语“静脉内导管装置”可与术语“导管装置”互换使用。应当理解,术语“静脉内导管装置”和“导管装置”涉及同一装置。如图1中所示的静脉内导管装置(100)包括导管套(102)(在图3中更清楚地示出,其中示出了导管套(102)的放大视图并且已经由图2中的部分“A”指示)。
导管装置(100)还包括针头覆盖件(104),该针头覆盖件可以连接到导管套(102)使得针头覆盖件(104)上的凹部(106)与导管套(102)的伸出部(108)接合。针头覆盖件(104)还包括管状套筒(110),该管状套筒具有轴向延伸的狭缝(112)和用于接收针头(116)的孔(114),使得当针头(116)从导管套(102)抽出时,与导管套(102)处于紧密配合关系的针头覆盖件(104)脱离导管套(102)。在实施例中,导管装置(100)的针头覆盖件(104)包括安全机构或针刺安全装置(未示出),以用于在刺穿患者的血管(未示出)之后当针头(116)从导管套(102)抽出时防止针头(116)的尖端暴露。导管装置(100)还包括壳体(118),该壳体以局部的方式包围针头覆盖件(104)和针头套(120)。壳体(118)可设置有拇指抓握部(122),以用于在导管装置(100)的***或收回期间操作者(未示出)进行抓握。
壳体(118)能够经由肋部(未示出)可拆卸地连接到针头覆盖件(104)。此外,针头套(120)通过针头套(120)的延伸部分(126)可释放地连接至回流腔室(124),并且可以在一端处使用螺纹帽或鲁尔锁定帽(128)封闭。针头套(120)在另一端处与针头(116)固定地连接。流入到回流腔室(124)中的血液流确认血管被针头(116)刺穿。回流腔室(124)可包括多孔过滤器(130)(在图20a和图20b中示出)和覆盖件(未示出)中的任一者,以允许空气逸出且血液在回流腔室(124)内流动。回流腔室(124)可额外地包括疏水过滤器(132),以用于防止血液从回流腔室(124)溢出。
图4示出了图1至图3中所示的导管套(102)的立体图。该导管套(102)包括近端(134)和远端(136)。应当理解,如在本公开中使用的术语“近端”可定义为更靠近操作导管装置(100)的操作者的一端。如在本公开中使用的术语“远端”可定义为与“近端”相对并远离操作者的一端。在实施例中,导管套(102)可以由生物相容性材料制成,该生物相容性材料可以是刚性的并且可以牢固地保持与其相关联的部件。导管套(102)包括在导管套(102)的远端(136)处固定连接的导管管部(138)(在图1和2中示出)。导管管部(138)可由柔性或软质材料制成,包括但不限于塑料或聚合物或本质上是柔性/软质的生物相容性材料。导管管部(138)是具有孔(140)的细长形管状结构。导管管部(138)的孔(140)适于围绕静脉内导管装置(100)的针头(116)。导管管部(138)可以适于通过一方法与导管套(102)固定,该方法包括但不限于压配合或粘性结合或本领域中已知的任何其他方法,以便用于将导管管部(138)与导管套(102)保持的目的。在另一实施例中,导管管部(138)可以与导管套(102)一体地制造。
在图1至图4所示的示例性实施例中,导管套(102)还包括邻接在导管套(102)的外表面(144)上的外端口(142),从而形成与导管套(102)的同轴凹部(148)连通的辅助流体路径(146)。因此,本实施例中的静脉内导管装置(100)适于具有双向流体机构。导管套(102)的外端口(142)可设置有用于打开和关闭用于供应流体(未示出)的外端口(142)的分配盖(150)(在图1和2中示出)。分配盖(150)可以经由铰链或螺纹或者本领域已知的任何其他机构操作来打开和关闭。
导管套(102)还包括在导管套(102)的内表面(154)上的环形止动件(152)。环形止动件(152)设置在导管套(102)的近端(134)处。导管套(102)的同轴凹部(148)包括底切部分(156)(在图3和图8中示出)。在所示的实施例中,底切部分(156)设置成朝向导管套(102)的远端(136)。在所示的实施例中,鲁尔锁定帽(128)设置成密封导管套(102)的近端(134)。导管套(102)适于容纳导管装置(100)的阀瓣构件(158)。
在图1至3中所示,阀瓣构件(158)适于设置在导管套(102)的同轴凹部(148)内。阀瓣构件(158)由柱形部分(160)(在图6a中更清晰地示出)和设置在柱形部分(160)的一端处的弯曲部分(162)(在图6a中更清晰地示出)限定。阀瓣构件(158)的柱形部分(160)在内表面(166)处具有突起部(164)(在图6b中示出)。阀瓣构件(158)还包括从柱形部分(160)延伸到弯曲部分(162)的同轴凹部(168)(在图6b中示出)。在所示的实施例中,弯曲部分(162)是凸形形状的,然而,弯曲部分(162)还可以是其他形状,诸如但不限于截头锥形形状。如在本公开中使用的术语“弯曲部分”和“凸形部分”是可互换使用的,并且它们指的是阀瓣构件(158)的同一部分。阀瓣构件(158)的凸形部分(162)设置有一个或多个狭缝(170),从而限定多个分支部(172)。一个或多个狭缝(170)设计为允许针头(116)穿过狭缝(170),使得在针头(116)抽出后,狭缝(170)能够自密封。
在所示的实施例中,阀瓣构件(158)适于在阀瓣构件(158)的第一端(174)邻接导管套(102)的环形止动件(152)时在导管套(102)的同轴凹部(148)处保持就位。在示例性实施例中,阀瓣构件(158)是由选自由硅树脂和橡胶组成的组的柔性材料制成的,其中狭缝(170)具有诸如但不限于“Y”形或倒“Y”形或“X”形的形状、或者水平狭缝或竖直狭缝或者“+”形的形状或者相同或任何其他形状的组合,这些形状将在将针头(116)和致动器构件(176)分别***阀瓣构件(158)的同轴凹部(168)内期间有助于使多个分支部(172)张开和扩张。
图5示出了图1至图4所示的根据本公开的示例性实施例的静脉内导管装置(100)的致动器构件(176)的立体图。该致动器构件(176)包括具有径向延伸的凸缘(180)的第一端(178)、具有凸形表面(184)的第二端(182)以及在致动器构件(176)的第一端(178)与第二端(182)之间的轴向孔(186)。在示例性实施例中,致动器构件(176)是由本领域已知的医用相容性材料制成,诸如但不限于刚性塑料材料(例如聚甲醛(POM))或金属(例如不锈钢)。
致动器构件(176)还包括在外表面(190)上的圆形凹部(188)。阀瓣构件(158)的突起部(164)适于与致动器构件(176)的圆形凹部(188)接合。阀瓣构件(158)的突起部(164)和致动器构件(176)的圆形凹部(188)的接合使阀瓣构件(158)与致动器构件(176)的组件完整地置于导管套(102)内部,使得阀瓣构件(158)和致动器构件(176)的组件不从导管套(102)落下。在另一实施例中,阀瓣构件(158)和致动器构件(176)可以通过除了突起部(164)和凹部(188)之外的任何其他方法来连接,例如本领域中已知的螺纹(未示出)或卡扣配合布置(未示出)等。在又一实施例中,致动器构件(176)可以包括类似于在阀瓣构件(158)上制造的突起部(164)的突起部,并且阀瓣构件(158)可以包括类似于致动器构件(176)的圆形凹部(188)的圆形凹部。应当理解,在致动器构件(176)和阀瓣构件(158)上制造的圆形凹部(188)和突起部(164)不应当限制本公开的范围,并且还可以使用使致动器构件(176)和阀瓣构件(158)协调的目的的任何适当的机构(例如:螺纹)。
图7a至图7d示出了图1至图4所示的根据本公开示例性实施例的静脉内导管装置(100)的阀瓣闭合构件(192)的多个视图。阀瓣闭合构件(192)包括在近端(196)处的第一表面(194)、在远端(200)处的第二表面(198)以及在近端(196)和远端(200)之间延伸的通孔(202)。阀瓣闭合构件(192)设置在导管套(102)的内部,使得阀瓣闭合构件(192)的第二表面(198)邻接导管套(102)的底切部分(156),并且阀瓣闭合构件(192)的第一表面(194)邻接阀瓣构件(158)的凸形部分(162)。
在所示实施例中,阀瓣构件(158)的凸形部分(162)符合阀瓣闭合构件(192)的第一表面(194)的形状。在实施例中,阀瓣闭合构件(192)的硬度在从约50肖氏硬度到约80肖氏硬度的范围内,并且阀瓣构件(158)的硬度在从约20肖氏硬度到约45肖氏硬度的范围内。
图8示出了根据本公开示例性实施例的静脉内导管装置(100)的截面图,其示出了用于血管穿刺的静脉内导管装置(100)的操作。当针头(116)穿过导管套(102)的同轴凹部(148)并且经过致动器构件(176)时,针头(116)适于刺穿阀瓣构件(158)的狭缝(170)。在刺穿阀瓣构件(158)的狭缝(170)之后,针头(116)穿过导管管部(138)以刺穿患者的血管。
当在刺穿血管后抽出针头(116)时,阀瓣构件(158)的狭缝(170)将自关闭,这是因为阀瓣构件(158)是由柔性材料制成的,该柔性材料可自关闭在阀瓣构件(158)的凸形部分(162)的狭缝(170)处的开口。
在实施例中,导管装置(100)可包括本领域已知的针刺安全装置(未示出)。针刺安全装置可以适于容纳针头(116)的尖端以位于针头覆盖件(104)内。在实施例中,针刺安全装置可以包括弹簧保持器(未示出),从而保持针头(116)的放大尺寸部分(未示出),由此防止针头(116)的尖端暴露于针头覆盖件(104)的外部,以防止***害操作者或对患者。
图9示出了根据本公开的实施例的静脉内导管装置(100)的截面图,其示出了当鲁尔锁定构件(206)可释放地连接至导管装置(100)时,导管装置(100)产生用于流体流动的通道(204)的操作。在所示实施例中,鲁尔锁定构件(206)经由本领域中已知的手段(诸如但不限于6%通用渐缩部)可释放地连接在导管套(102)的近端(134)处。具有6%通用渐缩部的鲁尔锁定构件不应旨在限制本公开的范围。可以使用符合导管装置(100)的附件部分的标准尺寸或具有ISO标准的任何鲁尔锁定构件。例如,ISO标准ISO-80369-20和ISO-80369-7可以用于具有6%通用渐缩部的鲁尔锁定构件。
在另一实施例(未示出)中,鲁尔锁定构件(206)可以具有可从不同供应商或制造商购得的任何构造或形状。一种这样的形状可以是鲁尔滑动件而不是鲁尔锁定件。只要鲁尔锁定件或鲁尔滑动件遵循6%的渐缩部,该装置的功能就将保持不变。
鲁尔锁定构件(206)在导管套(102)的近端(134)处的接合在致动器构件(176)上产生沿导管套(102)的轴线(X-X')并朝向导管套(102)的远端(136)的力。也就是说,当鲁尔锁定构件(206)的前端(208)适于接触致动器构件(176)的凸缘(180)时,致动器构件(176)在朝向导管套(102)的远端(136)的方向“D1”上轴向地移位。致动器构件(176)的朝向导管套(102)的远端(136)的轴向移位使阀瓣构件(158)的多个分支部(172)张开,以形成用于从导管套(102)的近端(134)到导管套(102)的远端(136)的用于流体流动的通道(204)。
图10示出了当鲁尔锁定构件(206)处于脱离位置中时图9所示的静脉内导管装置(100)的截面图。当鲁尔锁定构件(206)与导管套(102)脱离时,导管装置(100)中的阀瓣闭合构件(192)适于使阀瓣构件(158)的多个分支部(172)闭合,从而闭合用于流体流动的通道(204)并防止从患者的被穿刺的血管流出的血液从导管套(102)的远端(136)流动到导管套(102)的近端(134)。
这是由于以下事实:阀瓣闭合构件(192)的硬度大于阀瓣构件(158)的多个分支部(172)的硬度,并且当鲁尔锁定构件(206)与导管套(102)脱离时,阀瓣闭合构件(192)在远离导管套(102)的远端(136)的方向“D2”上推动阀瓣构件(158)的多个分支部(172)并推动致动器构件(176),由此闭合用于流体流动的通道(204)并防止从患者的被穿刺的血管流出的血液从导管套(102)的远端(136)流到导管套(102)的近端(134)。
优点:
在致动器构件(176)由于鲁尔锁定构件(206)的移除而移位时,所公开的阀瓣闭合构件(192)推动或闭合静脉内导管装置(100)的多个分支部(172),此时,防止来自患者血管的血液的不希望的反向流动。
所公开的阀瓣闭合构件(192)和致动器构件(176)可被多次启用或停用,以允许当患者的血管被刺穿时血液流过针头或者允许防止不希望的血液反向流动,这种流动/防止流动的功效在每次启用或停用中是类似的。
在与阀瓣闭合构件(192)的硬度相比,所公开的阀瓣构件(158)的多个分支部(172)是柔性的,防止在刺穿血管之后抽出针头(116)时,多个分支部(172)通过自身自动地向后折来闭合狭缝(170)。
所公开的静脉内导管装置(100)防止患者的血液接触用户的手,这是因为由于阀瓣构件(158)的多个分支部(172)通过阀瓣闭合构件(192)闭合而防止血液的反向流动。因此,防止了可能由于血液接触而引起的感染和死亡。
所公开的静脉内导管装置(100)是经济的,这是因为阀瓣构件(158)、致动器构件(176)和阀瓣闭合构件(192)的组件由塑料或生物相容性材料制成。
所公开的静脉内导管装置(100)提供了阀瓣构件(158)的狭缝(170)的改进的闭合,这是因为阀瓣构件(158)的多个分支部(172)由于通过阀瓣闭合构件(192)朝向用户或操作者的导管套(102)的近端(134)作用的推力而闭合,由此闭合通道(204)不允许血液的反向流动。
工业实用性:
所公开的阀瓣构件(158)、致动器构件(176)和阀瓣闭合构件(192)的组件能够用于图13、图16和图19所示的一种或多种类型的导管套(102-A、102-B、102-C)。图13、图16和图19中公开的导管套(102-A、102-B、102-C)分别用在图11、图12、图14、图15、图17和图18所示的导管装置(100-A、100-B、100-C)中。因此,阀瓣构件(158)、致动器构件(176)和阀瓣闭合构件(192)的组件的应用不意味着限于具有如图1至图4中公开的具有导管套(102)的静脉内导管装置(100)。
所公开的阀瓣闭合构件(192)可在需要防止血液或药物流体反向流动的其他合适医学装置中得到应用。
虽然已经参考上述实施例具体地示出和描述了本发明的各方面,但本领域技术人员将理解,在不脱离所公开的范围的情况下,可通过对所公开的装置的修改来构想各种其他实施例。这些实施例应理解为落在基于权利要求及其任何等同物确定的本发明的范围内。
参考标号和字符的列表:
100:导管装置或静脉内导管装置
100-A:另一实施例的导管装置
100-B:又一实施例的导管装置
100-C:另一实施例的导管装置
102:导管套
102-A:另一实施例的导管套
102-B:又一实施例的导管套
102-C:另一实施例的导管套
104:针头覆盖件
106:针头覆盖件的凹部
108:导管套的伸出部
110:管状套筒
112:管状套筒的狭缝
114:管状套筒的孔
116:针头
118:壳体
120:针头套
122:拇指抓握部
124:回流腔室
126:回流腔室的延伸部分
128:鲁尔锁定帽
130:多孔过滤器
132:疏水过滤器
134:导管套的近端
136:导管套的远端
138:导管管部
140:导管管部的孔
142:外端口
144:导管套的外表面
146:辅助流体路径
148:导管套的同轴凹部
150:分配盖
152:环形止动件
154:导管套的内表面
156:导管套的底切部分
158:阀瓣构件
160:阀瓣构件的柱形部分
162:阀瓣构件的弯曲部分或凸形部分
164:柱形部分的内表面上的突起部
166:柱形部分的内表面
168:阀瓣构件的同轴凹部
170:一个或多个狭缝
172:多个分支部
174:阀瓣构件的第一端
176:致动器构件
178:致动器构件的第一端
180:致动器构件的径向延伸的凸缘
182:致动器构件的第二端
184:凸形表面
186:致动器构件的轴向孔
188:致动器构件的圆形凹部
190:致动器构件的外表面
192:阀瓣闭合构件
194;阀瓣闭合构件的第一表面
196:阀瓣闭合构件的近端
198:第二表面
200:阀瓣闭合构件的远端
202:阀瓣闭合构件的通孔
204:用于流体流动的通道
206:鲁尔锁定构件
208:鲁尔锁定构件的前端
A:放大部分
D1:方向
D2:方向
X-X':导管套的轴线
Claims (14)
1.一种静脉内导管装置(100),包括:
导管套(102),所述导管套具有:近端(134)和远端(136);同轴凹部(148),该同轴凹部具有设置在所述导管套(102)的近端(134)处的环形止动件(152);以及底切部分(156),所述底切部分朝向所述导管套(102)的远端(136)设置;
阀瓣构件(158),适于设置在所述导管套(102)的同轴凹部(148)内部,所述阀瓣构件(158)由柱形部分(160)和设置在所述柱形部分(160)的一端处的弯曲部分(162)限定,一同轴凹部(168)从所述柱形部分(160)延伸至所述弯曲部分(162),所述弯曲部分(162)设置有限定多个分支部(172)的一个或多个狭缝(170),其中,所述狭缝(170)构造成允许针头(116)穿过所述狭缝(170)以刺穿患者的血管;
回流腔室(124),适于设置在所述导管套(102)的近端(134)处,其中,流入所述回流腔室(124)的血流确认所述针头(116)刺穿血管;
致动器构件(176),所述致动器构件具有轴向孔(186),所述致动器构件(176)适于设置在所述阀瓣构件(158)的同轴凹部(168)内,其中,当鲁尔锁定构件(206)能移除地连接在所述导管套(102)的邻接所述致动器构件(176)的近端(134)处时,所述致动器构件(176)沿朝向所述导管套(102)的远端(136)的方向(D1)轴向地移位,由此,使所述阀瓣构件(158)的所述多个分支部(172)张开,以形成从所述导管套(102)的近端(134)到所述导管套(102)的远端(136)的用于流体流动的通道(204);
其特征在于:
所述静脉内导管装置还包括阀瓣闭合构件(192),所述阀瓣闭合构件包括在近端(196)处的第一表面(194)、在远端(200)处的第二表面(198)以及在该近端(196)与该远端(200)之间延伸的通孔(202),所述阀瓣闭合构件(192)设置在所述导管套(102)内部,使得所述阀瓣闭合构件(192)的所述第一表面(194)邻接所述导管套(102)的所述底切部分(156),并且所述阀瓣闭合构件(192)的所述第二表面(198)邻接所述阀瓣构件(158)的所述弯曲部分(162),
其中,所述阀瓣闭合构件(192)适于使所述阀瓣构件(158)的所述多个分支部(172)闭合,由此,当邻接所述致动器构件(176)的所述鲁尔锁定构件(206)被移除时,闭合所述用于流体流动的通道(204)并防止从患者的被刺穿的血管流出的血液从所述导管套(102)的远端(136)流到所述导管套(102)的近端(134)。
2.根据权利要求1所述的静脉内导管装置(100),其中,所述阀瓣闭合构件(192)的硬度在从约50肖氏硬度至约80肖氏硬度的范围内,并且所述阀瓣构件(158)的硬度在从约20肖氏硬度至约45肖氏硬度的范围内。
3.根据权利要求1所述的静脉内导管装置(100),其中,所述阀瓣闭合构件(192)的所述第一表面(194)是凹形形状的或呈腔体形式的截头锥形形状的。
4.根据权利要求1所述的静脉内导管装置(100),其中,所述阀瓣构件(158)的所述弯曲部分(162)是凸形形状的或截头锥形形状的。
5.根据权利要求1所述的静脉内导管装置(100),其中,当所述阀瓣构件(158)的第一端(174)邻接所述导管套(102)的所述环形止动件(152)时,所述阀瓣构件(158)适于在所述导管套(102)的同轴凹部(148)处保持就位。
6.根据权利要求1所述的静脉内导管装置(100),其中,所述阀瓣构件(158)由选自由硅树脂和橡胶组成的组中的柔性材料制成。
7.根据权利要求1所述的静脉内导管装置(100),其中,所述狭缝(170)是Y形的、X形的、+形的或它们的组合。
8.根据权利要求1所述的静脉内导管装置(100),其中,所述阀瓣构件(158)的所述柱形部分(160)在内表面(166)处具有突起部(164)。
9.根据权利要求1至8中任一项所述的静脉内导管装置(100),其中,所述致动器构件(176)具有在所述致动器构件(176)的外表面(190)处的圆形凹部(188),并且其中,所述阀瓣构件(158)的所述突起部(164)适于与所述致动器构件(176)的所述圆形凹部(188)接合,由此,将所述阀瓣构件(158)和所述致动器构件(176)的组件完整地置于所述导管套(102)内部。
10.根据权利要求1所述的静脉内导管装置(100),其中,所述致动器构件(176)包括具有径向延伸的凸缘(180)的第一端(178)、具有凸形表面(184)的第二端(182)以及在所述致动器构件(176)的第一端(178)与第二端(182)之间的所述轴向孔(186)。
11.根据权利要求1所述的静脉内导管装置(100),其中,所述阀瓣闭合构件(192)的硬度比所述阀瓣构件(158)的所述多个分支部(172)的硬度大,当所述鲁尔锁定构件(206)与所述导管套(102)脱离时,所述阀瓣闭合构件(192)沿远离所述导管套(102)的远端(136)的方向(D2)推动所述多个分支部(172)和所述致动器构件(176),由此闭合所述用于流体流动的通道(204)并防止从患者的被刺穿的血管流出的血液从所述导管套(102)的远端(136)流到所述导管套(102)的近端(134)。
12.根据权利要求1所述的静脉内导管装置(100),其中,所述致动器构件(176)由刚性塑料材料或金属制成。
13.根据权利要求1所述的静脉内导管装置(100),其中,所述回流腔室(124)包括多孔过滤器(130)和覆盖件中的任一者,以允许空气逸出并且允许血液在所述回流腔室(124)内部流动。
14.根据权利要求1至13中任一项所述的静脉内导管装置(100),所述静脉内导管装置包括针刺安全装置。
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JP2024026705A (ja) | 2024-02-28 |
US12017011B2 (en) | 2024-06-25 |
EP4028104A1 (en) | 2022-07-20 |
EP4028104A4 (en) | 2023-12-13 |
JP2022551563A (ja) | 2022-12-12 |
US20210370020A1 (en) | 2021-12-02 |
JP7424680B2 (ja) | 2024-01-30 |
CA3169051A1 (en) | 2021-03-18 |
WO2021048867A1 (en) | 2021-03-18 |
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