CN110072589A - 安全针装置 - Google Patents

安全针装置 Download PDF

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Publication number
CN110072589A
CN110072589A CN201780076971.6A CN201780076971A CN110072589A CN 110072589 A CN110072589 A CN 110072589A CN 201780076971 A CN201780076971 A CN 201780076971A CN 110072589 A CN110072589 A CN 110072589A
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China
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path
navigation
sheath
shell
needle device
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Granted
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CN201780076971.6A
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CN110072589B (zh
Inventor
L·桑德斯
D·斯旺森
J·海耶斯
G·威拉德
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Becton Dickinson and Co
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Becton Dickinson and Co
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    • A61M5/3271Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
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  • Health & Medical Sciences (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Portable Nailing Machines And Staplers (AREA)

Abstract

一种安全针装置,其具有被构造成联接至注射器的壳体,该壳体具有近侧端、远侧端及壳体主体。第一引导路径、第二引导路径以及第三引导路径可以设置于壳体主体上。针座设置于壳体的近侧端上,针插管附接至针座。该装置具有可回缩护套,其被构造成相对于壳体在初始位置、回缩位置及伸出位置之间运动,初始位置部分地暴露针插管的远侧尖端,回缩位置完全地暴露针插管,伸出位置完全地覆盖针插管的远侧尖端。可回缩护套还可以具有引导元件。第一、第二及第三引导路径被构造成滑动地接收引导元件。该装置还具有第一锁定构件、第二锁定构件、设置于壳体主体中的旋转凸轮及弹簧元件,以在完成注射时将可回缩护套偏置至伸出状态以覆盖针插管的远侧端。

Description

安全针装置
技术领域
本发明总体上涉及一种安全针装置,更特别地涉及一种一次性被动安全针装置,其具有壳体、第一引导路径、第二引导路径、与所述第一引导路径和所述第二引导路径相交的第三引导路径、针座、针插管、可回缩护套、第一锁定构件、第二锁定构件、旋转凸轮以及弹簧,所述弹簧沿朝远侧方向偏置所述可回缩护套以覆盖所述针插管的远侧端。
背景技术
在整个医疗行业中使用针装置来将各种各样的流体和溶液注射至人体中以及从人体抽出。由于与体液、特别地血液的处理和操纵相关联的许多潜在的危险的存在,目前存在许多已知的安全特征,这些特征经常被包含至各种类型的针装置中以保护医师不被意外地暴露至针。
现有技术的安全针装置包含若干缺点,这些缺点包括:具有需要长的行程距离来启动安全特征的可回缩护套;多构件回缩和锁定元件;以及在接受注射时在安全特征的启动期间向患者的皮肤传递不希望的显著的力。传统的回缩式注射器组件通常也不包含防止重复使用的特征,并且因此,注射器的回缩机构可能被重置,所以注射器筒可能被重复使用。没有灭菌或没有充分灭菌的注射器组件的重复使用被认为有助于接触性传染病的转移。进一步,传统注射器的回缩特征还可能需要使用者主动地启动回缩机构。因此,由于人为错误而未启动或未能适当地启动回缩机构的可能性会导致针的持续暴露,从而导致针刺伤。
某些已知的回缩护套安全针装置已经被发展成包含一次性安全针装置组件,其在注射过程之前、期间以及之后将注射针的绝大部分或全部遮挡于视野之外。然而,许多注射过程要求医师精确地知道针被插入至患者的组织中的位置和深度,以确保药物被传递至适当的位置。另外,由于现有技术的回缩护套安全针装置的尖端在未锁定状态中被完全地覆盖,即使在未锁定的初始状态中,也存在许多使用者错误地认为他们对针刺伤是“安全的”的趋向。
因此,需要在本领域中提供一种具有被动致动机构的安全针装置,其克服已知的回缩护套安全针装置的缺陷并且容许更短的行程距离,易用性强,增加的患者舒适度,零件数量少,零件复杂度低,设计相对紧凑,以及针在初始位置中的清晰的且无遮挡的视野。
发明内容
本发明的一个方面涉及一种安全针装置,其包含被构造成联接至注射器的壳体,所述壳体具有近侧端、远侧端以及壳体主体。所述安全针装置还包含设置于所述壳体主体上的第一引导路径、第二引导路径以及第三引导路径,所述第二引导路径与所述第一引导路径和所述第三引导路径二者相交。在一个或多个实施例中,所述第一引导路径、第二引导路径以及第三引导路径中的一个或多个引导路径可以为笔直的路径,并且所述一个或多个引导路径可以为螺旋形。在一个或多个实施例中,所述第一引导路径、第二引导路径以及第三引导路径中的两个引导路径可以为笔直的路径,并且一个引导路径可以为螺旋形。在一个或多个实施例中,所述第一引导路径和第三引导路径可以为笔直的路径,并且所述第二引导路径可以为螺旋形。针座设置于所述壳体的近侧端上,其中针插管附接至所述针座。所述安全针装置还可以包含具有引导元件的可回缩护套,所述引导元件被构造成相对于所述壳体在初始位置、回缩位置以及伸出位置之间运动,其中所述初始位置部分地暴露所述针插管的远侧尖端,所述回缩位置完全地暴露所述针插管,并且所述伸出位置完全地覆盖所述针插管的远侧尖端。所述第一引导路径和所述第二引导路径设置于所述壳体主体上,被构造成接收所述引导元件。所述安全针装置还包含第一锁定构件、第二锁定构件;设置于所述壳体主体中并连接至所述可回缩护套的旋转凸轮;以及弹簧元件。在一个或多个实施例中,所述安全针装置为一次性装置。在一个或多个实施例中,所述安全针装置为被动启动装置,其中安全特征提供注射后针屏蔽而无需使用者额外干预。
在一个或多个实施例中,所述第一锁定构件可以包括所述可回缩护套的远侧端上的接片以及所述壳体上的锁定肋。在一个或多个实施例中,所述第一锁定构件可以包括所述可回缩护套的远侧端上的锁定肋以及所述壳体上的接片。所述可回缩护套从所述初始位置运动至所述回缩位置可以使所述壳体的锁定肋接合至所述可回缩护套的远侧端上的接片。所述可回缩护套在从所述初始位置运动至所述回缩位置期间可以相对于所述壳体旋转。所述可回缩护套从所述初始位置旋转至所述回缩位置可以经由所述第二引导路径将所述可回缩护套的所述引导元件从所述壳体上的所述第一引导路径传递至所述壳体上的所述第三引导路径。在一个或多个实施例中,所述引导元件可以为栓。在一个或多个实施例中,所述可回缩护套不受阻碍地从所述初始位置平移至所述回缩位置。
在一个或多个实施例中,所述可回缩护套从所述回缩位置运动至所述伸出位置可以使所述第二锁定构件接合至所述针插管的远侧尖端。在一个或多个实施例中,所述第二锁定构件可以为金属闩销。
在一个或多个实施例中,所述第一锁定构件可以通过阻止所述可回缩护套的旋转而阻止所述安全针装置的重复使用。所述第二锁定构件可以通过阻止所述可回缩护套的平移而阻止所述安全针装置的重复使用。
在一个或多个实施例中,所述弹簧元件朝向所述伸出位置偏置所述可回缩护套。当所述可回缩护套处于所述伸出位置中时,所述针插管被遮挡于视野之外。
在一个或多个实施例中,所述弹簧元件为螺旋弹簧。
附图说明
图1示出根据第一实施例的安全针装置的分解图;
图2示出图1中所示的处于初始状态中的安全针装置的立体图;
图3示出图1中所示的安全针装置的第一锁定元件的剖视图;
图4示出图1中所示的安全针装置的第一锁定元件的另一个剖视图;
图5示出根据第一实施例的安全针装置的剖视图;
图6示出根据第一实施例的安全针装置的另一个剖视图;
图7示出图1中所示的处于回缩状态中的安全针装置的立体图;
图8示出图1中所示的处于伸出状态中的安全针装置的立体图;以及
图9示出根据第一实施例的安全针装置的立体图。
具体实施方式
在描述本发明的若干示例性实施例之前,应当理解的是,本发明不限于在以下描述中所阐述的构造或过程步骤的细节。本发明能够具有其它实施例并且能够以各种方式实践或执行。
关于本发明中所使用的术语,提供以下定义。
当在本文中使用时,“一”、“一个”以及“所述”的使用包含单数和复数。
在本发明中,遵循惯例,其中装置的远侧端为最靠近患者的端,并且装置的近侧端为远离患者并且最靠近医师的端。
当在本文中使用时,“安全针装置”指具有适合于注射的针的装置,其包含一个或多个特征以防止针刺伤。当在本文中使用时,“被动安全针”指具有被动致动机构的安全针装置,所述被动致动机构在患者已经被注射之后自动地覆盖针的远侧端。
所涉及的“注射器”包含适用于与针、喷嘴、管一起使用的或者用于在冲洗系统中使用的注射器。当在本文中使用时,术语“注射器”指包括柱塞杆的简单的泵状装置,所述柱塞杆紧密地安装于筒或管中。柱塞杆可以在筒内部被拉动或推动,使注射器能够通过筒的开口端处的开口吸入和排出液体或气体。注射器的开口端可以安装有针、喷嘴或管,以帮助引导流体流入和流出筒。根据技术人员的需要,注射器可以为无菌的或未消毒的。
本发明的安全针装置的实施例提供一种被动致动机构,其通过容许更短的锁定行进距离、易用性、增加的患者舒适度、较少的零件数量、低零件复杂度、相对紧凑的设计以及针在初始位置中的清晰的且无遮挡的视野来克服已知的回缩护套安全针装置的缺陷。
图1-9示出根据本发明的示例性安全针装置10。安全针装置10包含被构造成联接至注射器(未示出)的壳体20。壳体20具有近侧端21、远侧端22、壳体主体23以及位于远侧端上的开口24。第一引导路径30、第二引导路径32以及第三引导路径34设置于壳体主体23上。第一引导路径30和第三引导路径34大致平行于沿着壳体主体23延伸的中心轴线。第二引导路径32相对于所述中心轴线以一定的角度、曲率或锥度定位并且与第一引导路径30和第三引导路径34相交,从而用来分离第一引导路径30和第三引导路径34。第二引导路径32允许引导元件52在第一引导路径30与第三引导路径34之间移动。在一个或多个实施例中,其中的一个或多个引导路径可以为笔直的路径,并且其中的一个或多个引导路径可以为螺旋形。在一个或多个实施例中,两个引导路径可以为笔直的路径,并且一个引导路径可以为螺旋形。在一个或多个实施例中,第一和第三引导路径可以为笔直的路径,并且第二引导路径可以为螺旋形。在一个或多个实施例中,第一引导路径30、第二引导路径32以及第三引导路径34设置于壳体主体23的内径上以防止篡改。在一个或多个实施例中,第一引导路径30、第二引导路径32以及第三引导路径34设置于壳体主体23的内径上,以便不妨碍针插管/针尖可见性。
壳体20可以为整体构造,或者可以由多个构件形成。在一个或多个实施例中,壳体20的近侧端21和远侧端22可以为使用技术(比如但不限于声波焊接、粘合剂粘合、卡合或压配合等等)接合的单独的构件。
如图1中所示,壳体20的近侧端21联接至可回缩护套50,以使得可回缩护套50被构造成沿着中心轴线运动并至少部分地围绕中心轴线旋转。通道和孔包含于可回缩护套50中,以允许针插管42以及针插管42的远侧尖端44穿过其中。
针座40设置于壳体20的近侧端21上。针插管42附接至针座40。可回缩护套50的近侧端包含被构造成相对于壳体20在初始位置、回缩位置以及伸出位置之间运动的引导元件52,其中初始位置部分地暴露针插管42的远侧尖端44,回缩位置完全地暴露针插管42,并且伸出位置完全地覆盖针插管42的远侧尖端44。术语“可回缩护套”旨在包含任何种类的管状构件和U形构件。如本领域技术人员将理解的,可回缩护套50的尺寸被设计成与针插管42的尺寸和类型相容。壳体20包含具有内部中空区域的壳体主体23,可回缩护套50可以沿朝近侧以及朝远侧方向在所述内部中空区域中运动。第一引导路径30、第二引导路径32以及第三引导路径34设置于壳体主体23的内表面上,且被构造成在可回缩护套50运动期间引导该可回缩护套。在一个或多个实施例中,第一引导路径、第二引导路径以及第三引导路径被构造成滑动地接收可回缩护套50的引导元件52。
在一个或多个实施例中,壳体20的近侧端21可连接至鲁尔连接件或其它流体连接器。可回缩护套50可滑动地安装于壳体主体的远侧开口24中并且可在壳体主体的该远侧开口中运动,以可滑动地容置和包围从壳体20轴向地突出的针插管42。可回缩护套50的远侧端通常与壳体20的远侧端22齐平。
如图1中所示,针插管42可以连接至设置于壳体20的近侧端21处的针座40并且在针插管42的远侧尖端44处具有钝的尖端(未示出)或者带斜边的尖端(如图1中所示)。针插管42以将在本领域中被很好地理解的方式设置于针座40中。针座40可以与壳体20的近侧端21一体形成。针座40可以被构造成可移除地或永久地附接至注射器,或者替代地,针座40可以与注射器一体形成。例如,针座40可以包含内螺纹或外螺纹或者其它合适的联接、锁紧或锁定特征,比如接片、狭槽、突起、压配合件/卡合件等等,用于将该安全针装置可移除地联接至注射器。在某些实施例中,壳体20包含大致圆柱形的减小的针支撑件41,其从针座40轴向地延伸以支撑针插管42。壳体20和/或针座40与针插管42流体连通,以允许流体在注射器与针插管42之间通过。
针插管42从设置于壳体20中的针座40延伸并且延伸至远侧尖端44。针插管42的远侧尖端44部分地暴露并且从可回缩护套50的远侧端突出,以便在可回缩护套50处于初始位置中时为可见的,如图2中所示。当可回缩护套50处于回缩位置中时,针插管42的轴杆从可回缩护套50暴露。
如在若干附图、最主要地图1和2中所示出的,可回缩护套50通常包括管状部分,并且可沿着针插管42的长度可滑动地回缩,以使得在处于初始位置中时针插管42的远侧尖端44部分地暴露并从可回缩护套50的远侧端突出,以便对使用者可见。当可回缩护套50处于它的回缩位置中时,针插管42的大部分或整个部分暴露。当可回缩护套50处于它的伸出位置中时,沿朝远侧方向从针座40延伸的针插管42的长度被完全地包围,如图8中所示。
根据本发明的针插管42可以由常规材料(比如钢或更优选地不锈钢)形成。本领域技术人员将认识到的是,可以用医用级塑料、复合材料、陶瓷或类似材料代替。
可回缩护套50的内径被选择成使得它将紧密地安装于针插管42上。可回缩护套50可以由任何合适的材料制成,但是优选地由足够坚韧的聚合物制成以保护针插管42。
可回缩护套50的近侧端51包含引导元件52,其从可回缩护套50的近侧端径向向外延伸并且被构造成接合形成于壳体主体23的内表面上的一个或多个路径。在一个或多个实施例中,引导元件52可以为向外延伸的栓,其相对于壳体的远侧端的凸缘安置,如图2中所示。如图1和2中所示,壳体20具有接收可回缩护套50的开口。
在一个或多个实施例中,可回缩护套50可以设置于壳体主体23中并且可在壳体主体23中运动。可回缩护套50为弹簧加载式的,并且以该可回缩护套50部分地覆盖针插管42的方式被供应至使用者,以使得针插管的远侧尖端在初始状态中暴露并且为可见的,如图2中所示。在初始状态中,可回缩护套50的引导元件52设置于壳体主体的第一引导路径中。在一个或多个实施例中,引导元件为栓。在施用注射时,可回缩护套50从其中针插管42的远侧尖端44暴露的初始位置运动至其中针插管更多地暴露的回缩位置,以使得针插管可以穿透注射部位。如图3-7中所示,可回缩护套50在从初始位置运动至回缩位置期间通过旋转凸轮80相对于壳体20旋转。
在向患者施用注射期间,使用者沿朝远侧方向施加力致使可回缩护套50的引导元件52沿朝近侧方向运动,以使得引导元件从壳体主体的第一引导路径切换至壳体主体的成角度的第二引导路径。可回缩护套50从初始位置旋转至回缩位置经由第二引导路径32将可回缩护套的引导元件52从壳体主体23上的第一引导路径30传送至壳体主体上的第三引导路径34。在一个或多个实施例中,可回缩护套不受阻碍地从初始位置运动至回缩位置。
如图3-6中所示,使用者沿朝远侧方向继续施加力引起旋转凸轮80的旋转运动,致使引导元件52从壳体主体的第二引导路径运动至第三引导路径,从而启动第一锁定元件60。在一个或多个实施例中,第一锁定元件60包含可回缩护套的远侧端上的接片。在一个或多个实施例中,第一锁定元件60进一步包含壳体上的锁定肋。在一个或多个实施例中,第一锁定构件可以包括可回缩护套的远侧端上的锁定肋以及壳体上的接片。可回缩护套从初始位置运动至回缩位置使壳体的锁定肋接合至可回缩护套的远侧端上的接片。在某些实施例中,第一锁定元件60至少部分地定位于包含于壳体主体23中的开口内。在某些实施例中,第一锁定元件60通常为弹性的,以使得径向向内设置的第二端可以弯曲并且然后即使在所述端已经径向向外偏转之后返回至原始位置。在某些实施例中,第一端大于第二端,例如轴向锁定构件可以从第一端至第二端54逐渐变细。在一个或多个实施例中,第一锁定构件可以包含锁紧构件,比如钩、扣、棘爪、棘轮或其它结构。
在启动第一锁定构件时,壳体的锁定肋接合至可回缩护套的远侧端上的接片,从而防止旋转凸轮的进一步的旋转运动,并因此确保引导元件不会返回至它的在第一引导路径上的初始位置。当通过在希望插入针插管42的位置处使可回缩护套50压靠患者的皮肤而继续施加力时,可回缩护套50回缩至壳体20中,由此使得针尖和针插管穿透注射部位。在一个或多个实施例中,第一锁定构件通过阻止可回缩护套的旋转而阻止该装置的重复使用。
当完成对患者的注射时,使用者从患者抽出针插管,从而使弹簧元件90的所储存的能量容许可回缩护套50的引导元件52沿着第三引导路径34行进,以使可回缩护套50能够在伸出位置中完全地覆盖针插管42。弹簧元件90沿朝远侧方向偏置可回缩护套50以覆盖针插管42的远侧尖端44,引起第二锁定元件的启动以防止可回缩护套50在壳体主体23内的进一步的平移运动。可回缩护套从回缩位置运动至伸出位置使第二锁定构件接合至针插管的远侧尖端。
在一个或多个实施例中,第二锁定元件70设置于可回缩护套上并且沿着针插管行进,直至第二锁定元件在伸出位置中覆盖针插管42的远侧尖端44。在一个或多个实施例中,第二锁定元件70通过阻止可回缩护套50在壳体主体23内的进一步的平移运动而阻止安全针装置10的重复使用。当可回缩护套处于伸出位置中时,针插管42被遮挡于视线之外。如图8中所示,当注射完成并且针插管42的远侧尖端44被从注射部位拉出时,弹簧元件90的所储存的力致使可回缩护套50伸出,并且在行程结束时,第二锁定构件延伸于针插管42的远侧尖端44之上以锁定可回缩护套50,从而完成被动安全锁定。在一个实施例中,第二锁定构件为金属夹。
弹簧元件90包含近侧端、主体以及远侧端。在一个或多个实施例中,如图1中所示,弹簧元件90包括压缩弹簧或螺旋弹簧。弹簧元件90朝向伸出位置偏置可回缩护套。
图1示出安全针装置10,其可以被可移除地联接至标准的或特别地构造的注射器(未示出)。虽然所示安全针装置10被构造成联接至注射器并且被从注射器移除,但是安全针装置10可以替代地与注射器一体形成。注射器通常为适合于通过安全针装置10抽取以及注射和/或抽吸流体或其它溶液的已知类型。
现在参考图2,安全针装置10被显示为处于初始状态中,其中可回缩护套50处于部分地回缩的构造中。通常由使用者沿朝远侧方向在安全针装置10和/或注射器上施加压力而启动可回缩护套50的进一步的回缩,从而促使可回缩护套50向近侧抵抗弹簧元件90的偏置。可回缩护套50的该回缩继而进一步暴露针插管42的远侧尖端44,并开始通过针插管42穿透至患者皮肤中。壳体14的引导元件52(其最初被定位于第一引导路径30中)引导可回缩护套50立即地朝向第二引导路径32运动。当可回缩护套50向近侧运动时,引导元件52穿过第二引导路径32,从而促使可回缩护套50围绕轴线在旋转凸轮上旋转。当到达第二和第三引导路径的相交点时,引导元件52不可能会返回至第一引导路径30,这是因为旋转凸轮接合第一锁定构件,以使得壳体的锁定肋接合可回缩护套的远侧端上的接片,以防止旋转凸轮的进一步的旋转并因此防止引导构件返回至第一引导路径30。
在一个或多个实施例中,弹簧元件90接合可回缩护套的近侧端以及壳体的近侧端并且在可回缩护套的近侧端与壳体的近侧端之间延伸。弹簧朝向初始位置偏置可回缩护套50,在该初始位置中,可回缩护套50的引导元件52被偏置成与位于壳体主体23的远侧端处的第一引导路径接合,从而使针插管42的远侧尖端44在初始位置中能够暴露并且为可见的。可回缩护套50在伸出位置中完全地覆盖针插管42的远侧尖端44。可以采用许多类型的弹簧,比如但不限于螺旋弹簧、锥形弹簧、波形弹簧、贝氏垫圈或等等。在某些实施例中,弹簧元件90被构造成便于通过使用者用仅仅一只手向注射器和/或安全针装置10施加朝远侧的压力而使可回缩护套50回缩。
在一个或多个实施例中,如图3、4、5以及6中所示,旋转凸轮80包含向外延伸的部分,阻碍构件(比如接片或其它弹性构件)从所述部分延伸,例如以圆周地、径向地、轴向地、它们的组合等方式延伸。在一个或多个实施例中,旋转凸轮的阻碍构件的端部可以被形成为具有倾斜的面或平面的径向向外延伸的楔形物,其与楔形旋转锁定构件(例如轴向肋)相互作用,所述锁定构件从壳体的内表面径向向内延伸并且包含倾斜的面以及大致平坦的面。在一个或多个实施例中,楔形物的倾斜的面可以被构造成沿与所述倾斜的面相反的方向。所述端部以及旋转锁定构件可以为楔形、半球形、截头圆锥形等。在某些实施例中,旋转锁定构件的轴向长度大于阻碍构件的轴向长度。在某些实施例中,阻碍构件的至少一部分被构造成安装至旋转锁定构件的至少一部分中,反之亦然。例如,阻碍构件可以包括接片,其被构造成安装于包含于旋转锁定构件中的狭槽内。
可以使用足以提供所需形状的构件的许多制造工艺来形成安全针装置10以及其构件。在某些实施例中,通过成型工艺制造一个或多个构件,比如但不限于注射成型、压缩成型、吹塑成型、传递成型或类似工艺。在某些实施例中,通过锻造、机械加工、铸造、冲压、挤压、其组合等方式形成一个或多个构件。
在许多实施例中,安全针装置10由生物相容性材料构成。在某些布置中,安全针装置10的构件中的一个或多个为塑料(例如聚氨酯等等)或金属(例如,不锈钢等等)。在某些实施例中,壳体14和/或可回缩护套50由半透明的或不透明的材料构成。
在某些实施例中,可回缩护套50的运动自动地接合第一锁定元件60和第二锁定元件70。在某些实施例中,可回缩护套50从大致完全回缩位置运动至大致完全伸出位置而自动地防止或者阻止安全针装置10的重复使用。
在某些实施例中,可以通过形成带有针支撑件41、远侧开口24、第一引导路径30、第二引导路径32以及第三引导路径34的壳体20来制造安全针装置。在壳体20包括多个部件的实施例中,制造工艺可以包含组装壳体20的步骤。形成具有引导元件52的可回缩护套,所述引导元件与第一引导路径30对准。可回缩护套50通过远侧开口24滑动地运动。针插管42与壳体20的针支撑件41联接。弹簧元件90被插入至壳体主体23中并且被定位成偏置可回缩护套50。
如图7中所示,随着可回缩护套50继续回缩至壳体主体23中,以进一步使针插管42暴露至长度500,引导元件52从第二引导路径32移动至第三引导路径34,从而进一步使可回缩护套50相对于壳体20旋转。当针插管42被从患者抽出时,弹簧元件90的所储存的弹簧能量使可回缩护套50向远侧伸出。随着可回缩护套50向远侧伸出,它将针插管42覆盖至针座主体的通道中,从而覆盖针插管42的远侧端。可回缩护套50的向远侧的运动还使引导元件52沿着第三引导路径34滑动。第一锁定构件的接合阻止或防止可回缩护套50的反向旋转,这继而防止引导元件52在第一引导路径30与第二引导路径32之间的相交点处移动返回至第一引导路径30中。
如图8中所示,当可回缩护套50到达针插管42的远侧尖端44时,第二锁定元件70向远侧运动于远侧尖端之上以覆盖针插管42的远侧尖端44,以防止安全针装置10的重复使用。可回缩护套50已经完全地伸出并完全地覆盖针插管42。第二锁定元件70因此起到物理止动件的作用,以阻止可回缩护套50再次向近侧回缩。
壳体20联接至可回缩护套50,以使可回缩护套50能够沿着轴线平移以及至少部分地围绕轴线旋转。
因此,本发明的实施例利用在可回缩护套上的引导元件52,其沿着设置于壳体20内部的第一引导路径30、第二引导路径32以及第三引导路径34行进。一旦注射开始,可回缩护套50上的引导元件52就沿着第一引导路径30、第二引导路径32以及第三引导路径34行进,在它轴向地运动时使可回缩护套从初始位置旋转至第二位置。一旦旋转完成,包括有可回缩护套50的顶部处的两个锁定接片的第一锁定元件60就卡合至壳体20内的肋中。两个锁定接片用来阻止可回缩护套50旋转返回至初始位置,确保将发生用第二锁定元件70进行的最终的锁定。此时,使用者可以继续将针插入至患者中的所需的深度,并且可回缩护套50将在壳体路径内轴向地运动。在针插管被移除时,系统内的弹簧元件90将沿着第三引导路径34将可回缩护套50推动至最终位置,并且第二锁定元件70将自动地覆盖针插管42的远侧尖端44,从而被动地保护使用者免受针刺伤之害。
行程长度为针插管长度以及可回缩护套50的锁定行程的总和。可回缩护套50的近侧端与针插管42的远侧尖端44之间的距离为公差和安全界限的叠加,以确保在使用后防止针刺伤(NSI)。
在一个或多个实施例中,当容许弹簧元件在可回缩护套50以及壳体20内部塌缩时,可以减小安全针装置的总长度。因此,通过压并高度来减小总长度并且随后降低施加至患者的皮肤的力。
在一个或多个实施例中,还可以通过使用伸缩构件来减小安全针装置的总长度。
如图9中所示,在一个或多个实施例中,安全针装置10可以包含帽100,该帽被可移除地联接至壳体20,以在安全针装置10的运输和储存期间减少或防止针插管的污染。帽100通常被保持于关闭位置中,直至恰好在注射和/或抽吸过程之前,在那时帽100被从壳体20移除。在某些实施例中,帽100被构造成帮助适当地从小瓶抽取剂量。
包括有安全特征的任何合适的帽或包装可以与本文中所公开的安全针装置结合使用。包括有安全特征的任何合适的帽或包装可以与本文中所公开的安全针装置结合使用。安全特征的类型在结构和力学方面有所不同,但示例性帽或包装包含但不限于在共同拥有的美国专利申请第62/433,044号,第62/433,526号以及第62,433,297号中所描述的那些,所述美国专利申请的公开内容被通过引用全文并入本文中。
在整个说明书各处对“一个实施例”、“某些实施例”、“各个实施例”、“一个或多个实施例”或者“实施例”的引用意味着,结合所述实施例所描述的特定的特征、结构、材料或特性包含于本发明的至少一个实施例中。因此,在整个说明书的各个地方中出现的比如“在一个或多个实施例中”、“在某些实施例中”、“在各个实施例中”、“在一个实施例中”或者“在实施例中”的短语不一定指本发明的同一实施例。此外,特定的特征、结构、材料或特性可以在一个或多个实施例中以任何合适的方式组合。
虽然本文中的公开内容参考特定实施例提供描述,但是应当理解的是,这些实施例仅仅示例说明本发明的原理和应用。对于本领域技术人员而言将显而易见的是,在不脱离本发明的精神和范围的情况下,可以对本发明进行各种修改和变形。因此,本发明旨在包含处于所附权利要求以及它们的等同形式的范围内的修改和变形。

Claims (19)

1.一种安全针装置,包括:
壳体,该壳体被构造成联接至注射器,所述壳体具有近侧端、远侧端以及壳体主体;
设置于所述壳体主体上的第一引导路径、第二引导路径以及第三引导路径,所述第二引导路径与所述第一引导路径和所述第三引导路径二者相交;
设置于所述壳体的近侧端上的针座;
附接至所述针座的针插管;
具有引导元件的可回缩护套,所述可回缩护套被构造成相对于所述壳体在初始位置、回缩位置以及伸出位置之间运动,其中,在所述初始位置所述针插管的远侧尖端部分地暴露,在所述回缩位置所述针插管完全地暴露,并且在所述伸出位置所述针插管的远侧尖端被完全地覆盖,设置于所述壳体主体上的所述第一引导路径和所述第二引导路径被构造成接收所述引导元件;
第一锁定构件,
第二锁定构件;
设置于所述壳体主体中的旋转凸轮;以及
弹簧元件。
2.根据权利要求1所述的安全针装置,其特征在于,所述引导元件为栓。
3.根据权利要求1所述的安全针装置,其特征在于,所述第一锁定构件被被动地启动。
4.根据权利要求1所述的安全针装置,其特征在于,所述第一锁定构件包括在所述可回缩护套的远侧端上的接片。
5.根据权利要求4所述的安全针装置,其特征在于,所述第一锁定构件进一步包括在所述壳体上的锁定肋。
6.根据权利要求5所述的安全针装置,其特征在于,所述可回缩护套从所述初始位置运动至所述回缩位置使所述壳体的所述锁定肋接合至所述可回缩护套的远侧端上的所述接片。
7.根据权利要求1所述的安全针装置,其特征在于,所述可回缩护套在从所述初始位置运动至所述回缩位置期间相对于所述壳体旋转。
8.根据权利要求7所述的安全针装置,其特征在于,所述可回缩护套从所述初始位置旋转至所述回缩位置经由所述第二引导路径将所述可回缩护套的所述引导元件从所述壳体上的所述第一引导路径传送至所述壳体上的所述第三引导路径。
9.根据权利要求1所述的安全针装置,其特征在于,所述第二锁定构件包括金属闩销。
10.根据权利要求1所述的安全针装置,其特征在于,所述第二锁定构件被被动地启动。
11.根据权利要求1所述的安全针装置,其特征在于,所述可回缩护套从所述回缩位置运动至所述伸出位置使所述第二锁定构件接合至所述针插管的远侧尖端。
12.根据权利要求1所述的安全针装置,其特征在于,所述第一锁定构件通过阻止所述可回缩护套的旋转而阻止所述安全针装置的重复使用。
13.根据权利要求1所述的安全针装置,其特征在于,所述第二锁定构件通过阻止所述可回缩护套的平移而阻止所述安全针装置的重复使用。
14.根据权利要求1所述的安全针装置,其特征在于,所述弹簧元件朝向所述伸出位置偏置所述可回缩护套。
15.根据权利要求1所述的安全针装置,其特征在于,所述可回缩护套不受阻碍地从所述初始位置运动至所述回缩位置。
16.根据权利要求1所述的安全针装置,其特征在于,当所述可回缩护套处于所述伸出位置中时,所述针插管被遮挡于视野之外。
17.根据权利要求1所述的安全针装置,其特征在于,所述弹簧元件为螺旋弹簧。
18.一种安全针装置,包括:
壳体,该壳体被构造成联接至注射器,所述壳体具有近侧端、远侧端以及壳体主体;
设置于所述壳体主体上的第一引导路径、第二引导路径以及第三引导路径,所述第二引导路径与所述第一引导路径和所述第三引导路径二者相交;
设置于所述壳体的近侧端上的针座;
附接至所述针座的针插管;
具有引导元件的可回缩护套,所述可回缩护套被构造成相对于所述壳体在初始位置、回缩位置以及伸出位置之间运动,其中在所述初始位置所述针插管的远侧尖端部分地暴露,在所述回缩位置所述针插管完全地暴露,并且在所述伸出位置所述针插管的远侧尖端被完全地覆盖,设置于所述壳体主体上的所述第一引导路径和所述第二引导路径被构造成接收所述引导元件;
所述可回缩护套的远侧端上的锁定肋;
所述壳体上的接片;
设置于所述可回缩护套上的金属闩销;
设置于所述壳体主体中的旋转凸轮;以及
弹簧元件。
19.一种安全针装置,包括:
壳体,其具有近侧端、远侧端以及壳体主体;
设置于所述壳体主体上的第一引导路径、第二引导路径以及第三引导路径,所述第二引导路径与所述第一引导路径和所述第三引导路径二者相交;
设置于所述壳体的近侧端上的针座;
附接至所述针座的针插管;
具有引导元件的可回缩护套,所述可回缩护套被构造成相对于所述壳体在初始位置、回缩位置以及伸出位置之间运动,其中在所述初始位置所述针插管的远侧尖端部分地暴露,在所述回缩位置所述针插管完全地暴露,并且在所述伸出位置所述针插管的远侧尖端被完全地覆盖,设置于所述壳体主体上的所述第一引导路径和所述第二引导路径被构造成接收所述引导元件;
第一锁定构件,
第二锁定构件;
设置于所述壳体主体中的旋转凸轮;
弹簧元件;以及
可移除地联接至所述壳体的帽。
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