CN1173750C - 空心针器件 - Google Patents

空心针器件 Download PDF

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CN1173750C
CN1173750C CNB008162115A CN00816211A CN1173750C CN 1173750 C CN1173750 C CN 1173750C CN B008162115 A CNB008162115 A CN B008162115A CN 00816211 A CN00816211 A CN 00816211A CN 1173750 C CN1173750 C CN 1173750C
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彼得·杰弗里
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A61M2005/3235—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user triggered by radial deflection of the anchoring parts between needle mount and syringe barrel or needle housing, e.g. spreading of needle mount retaining hooks having slanted surfaces by engagement with correspondingly shaped surfaces on the piston at the end of an injection stroke
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A61M2005/3235—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user triggered by radial deflection of the anchoring parts between needle mount and syringe barrel or needle housing, e.g. spreading of needle mount retaining hooks having slanted surfaces by engagement with correspondingly shaped surfaces on the piston at the end of an injection stroke
    • A61M2005/3236—Trigger provided at the distal end, i.e. syringe end for mounting a needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A61M5/502—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/508—Means for preventing re-use by disrupting the piston seal, e.g. by puncturing

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Environmental & Geological Engineering (AREA)
  • Vascular Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Physical Or Chemical Processes And Apparatus (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

一种空心针器件(100)包括一个空心柱塞(105)，一个具有圆柱室(101)的外壳，柱塞(105)可在其中密封地滑动，一个可自动缩进到柱塞(105)中的带针套(120)，以及一个柱塞(105)的闭合装置(130)。闭合装置(130)包括一个闭合件(131)，它通常与靠近端部的空心柱塞(105)内部构造(133)形成密封关系，但在柱塞(105)挤压内含物的行程结束或接近结束时，依靠对闭合件(131)的局部的首先接合(135)，可以从柱塞脱开而整个移入空心柱塞(105)中。

Description

空心针器件
                       发明领域
本发明涉及了如皮下注射器和体液采样器的空心针器件；特别是涉及了这样的器件，它在用于挤压器件中的内含物之后，通常在一次使用之后考虑到自动地完全缩进空心针。
                       发明背景
我们的PCT申请号GB92/00652关于这类器件，其中针的缩进就是使带针的套进入一个柱塞的空心内部，柱塞能够用于把器件的内含物挤压通过针。当然，在内含物挤压时，柱塞需要闭合以后将接受带针套的一端和密封被挤压的内含物，但又要处于这样状态：在内含物挤压之后能够可靠地断开，以容许针和套按希望缩进到柱塞的空心内部。作为在柱塞端部的密封件的一个可断开的闭合装置，如一个可穿透或可碎裂薄膜，在技术上是可行的，包括使得在针缩进时按需要断开，通常被带针套本身的尖锐突起断开。然而，为了达到所有的需求，特别是对于打算单个使用，即一次性的空心针器件存在许多困难。
确切地说，在低加工成本下采用高速模制和自动装配零件，必须是大量生产，存在的问题是要一致和可靠地达到所需的长期完全密封和总是容许零件按需要自由通过的完全断开。当联系到寻求提供以下的断开方式时这些要求变得更加难以满足：与用于挤压内含物的力相比，作用在柱塞上的力没有增加或者最好低到不易察觉的微小增加，就可以达到柱塞端部闭合装置的完全有效的断开。可移位的滑动柱塞至少在这方面一般是不行的。
本发明的一个目的是提供一种柱塞闭合装置，具有更好的能力来满足自动缩进空心针器件的需求。
                       发明概述
按照本发明的一个方面特征，提供了一种空心针器件，包括一个空心柱塞，一个具有圆柱室的外壳，柱塞可在其中密封地滑动，一个可自动缩进到柱塞中的带针套，以及一个柱塞的闭合装置，闭合装置包括一个闭合件，它通常与靠近端部的空心柱塞内部构造形成密封关系，但在柱塞挤压内含物的行程结束或接近结束时，依靠对闭合件的局部的首先接合，可以从柱塞脱开而整个移入空心柱塞中。
美国专利号5,578,011作为先前技术引起了我们的注意，它表示了一个注射器柱塞闭合件的局部移动接合，但这种接合没有非对称性，仅具有闭合件的轴向移动，本发明的特征在于局部的首先接合是非对称的，造成了闭合件的倾斜运动。
至少对于上述的刚性闭合装置，它以首先倾斜运动方式而偏移时基本上不变形，密封关系可以沿着闭合件的周边，并且在这个周边内局部的移动接合可以是偏心的。
带针套本身可以与闭合件直接移动接合，套和闭合件中一个或者两个可以具有在外壳中上述柱塞对内含物挤压行程结束时保证这个接合为非对称的构造。
对于基本上为圆柱结构的典型空心针注射器式器件，闭合件可以是一个平的盘，直径小于柱塞内部直径，并且在其边厚内具有一条沿周边的槽，槽与靠近柱塞口的一条周向肋配合。闭合件的替代物包括任何其他非平的物体，只要具有一条环形槽来配合上述肋，另外容许闭合件容易从柱塞口有间隙地通过柱塞内部。
带针套和闭合件的典型接合构造包括一个在与闭合件偏心的位置上从套上局部突起物，例如一个可以整体模制的栓钉或齿形构造。相反的方式同样是可行的，即从闭合件上局部偏心突起物，或者某种组合；也可采用带有一个或两个这种局部突起物的任何所需的中间件。
可以看出，上述基本上平的带边槽的闭合件是称为“可倾斜盘”的一种特殊应用，这是一类早已知道的装置，在用适当的边界支承来抵抗比非对称作用的倾斜移动力大得多的基本均匀作用力时，能够充分地使盘从其边界支承位置上移开。如果这里的注射器式器件通常挤压液体形式的内含物，因此必然有均匀的液体压力，应用这种可倾斜盘是近于理想的方式。然而，十多年来对注射器式器件中针的自动缩进提出了无数的建议，至今没有作这方面的联想和这样来应用可倾斜盘。力的差异，即移动的力比承受的均匀作用力低得多，对仅打算单个使用的注射器式空心针器件来说具有深刻的意义。人的触觉能力非常敏感，并且可以靠经验得到训练。几乎为达到缩进所需力的任何增加均可以感觉到，即使是非常微小，从而造成了达不到限于单个使用的目的；但是这种作用力实际上比作用于内含物的所需挤压力低得多，这样将不被感觉到。
另外，力的差异提供了一个制造公差的裕量而不会有使缩进操作失败的风险，这对制造低成本器件及其零件是非常有价值的。
                       附图简述
现在描述和在附图中表示本发明的具体实施例，其中
图1是注射器式空心针器件100的纵向剖视图，具有这里所述的柱塞端部密封方式；
图2是图1中沿X-X的剖视图；
图3是一个分解的部分零件剖视图，表示了与柱塞端部密封和不密封有关的零件细节；
图4A、B和C是相似的视图，分别表示了这些零件在内含物挤压、接近挤压结束以及针自动缩进时的情形。
                       实施例描述
首先参照图1，和2，空心针注射器式器件100有利地具有一个细长空心圆柱形的单件模制外壳，它提供一个主室101，其中一个空心柱塞105可以密封地滑动，一个前室或扩展室110，它扩展到空心针出口头部111，并且装有一个缩进弹簧112；以及可移动的内部臂状锁扣115，它保持着带针套120，直到与柱塞105端部106接合，被用于针缩进的移动而释放时为止。器件100一般在已发表的PCT专利说明号WO 92/18187中公布，包括了从主室101到前室或扩展室110的合适的外壳台阶113和从后者到头部11的合适的外壳台阶114，以及与柱塞105法兰105配合的端部夹持法兰107。
柱塞105的内端构造包括周向的外凸圆边105B，可以有用地造成与主室101内部压缩接合方式的直接滑动密封，以及在105T上为与端锥115T配合的端锥形，端锥115T在可移动臂115端部向内扣住齿116。臂115表示为在外壳收缩区118之间的局部容纳区117中从锥形台阶113伸出，齿116抓住顶帽或T形截面带针套120的头部120H。而缩进弹簧112绕着套120的柄120S保持缩进。柱塞105端锥105T与臂115端锥115T的接合把臂115移入容纳区117的足够空间117S中而释放套120，与固定在套120通孔122中的针121一起，被弹簧112迫使通过空心柱塞105的端部密封件130而缩进到柱塞内部109。柱塞105在完全进入外壳时最好被卡住，参见配合的肋和槽的构造123、124。
柱塞端部的密封件130是可倾斜的盘式构造，可进一步参见图3和4。确切地说，如图所示，一个圆盘131在其厚度内具有一条周边槽132，空心柱塞105具有一条靠近端部的配合内肋133。肋133易于突出，因此对柱塞105的单件模制能力没有不利影响。盘131的外径稍小于空心柱塞105的内部109直径，以便在需要时可以在内部109中自由运动。在高速装配设备中易于达到盘131的卡接式插入，槽132沿整个周向接合在柱塞的肋133上。
保证用于盘131的模具具有一条靠近盘131主面而不是在槽中，最好基本上离开槽的分离线；以及外壳主室101的壁对柱塞105有某种程度的压缩作用，有助于在盘131和柱塞105之间的液体密封。外壳、柱塞105和盘131的适用材料分别为刚性的有核均聚物聚乙烯，不太刚性的高密度聚乙烯，以及较低密度的聚烯烃，通常为聚丙烯或聚乙烯。
与柱塞肋133配合的槽132沿周边定位和保持着盘131，盘将抵抗着均匀作用力(当柱塞105挤压主室101内含物通过针121时的液体压力)，它比足以使盘131从这个位置偏移的偏心作用力大得多。因此，带针套120的头部120H在靠近边上具有一个突起的塞子构造135，与盘131非对称地接合，并且在柱塞105挤压内含物行程结束时，使盘131偏移到柱塞105的内部109中。

Claims (12)

1.一种空心针器件(100)包括一个空心柱塞(105)，一个具有圆柱室的外壳(101)，柱塞(105)可在其中密封地滑动，一个可自动缩进到柱塞(105)中的带针套(120)，以及一个柱塞(105)的闭合装置(130)，闭合装置(130)包括一个闭合件(131)，它通常与靠近端部的空心柱塞(105)内部构造(133)形成密封关系，但在柱塞(105)挤压内含物的行程结束或接近结束时，依靠对闭合件(131)的局部的首先接合(135)，可以从柱塞(105)脱开而整个移入空心柱塞(105)中。
特征在于：局部的首先接合(135)是非对称的，造成闭合件(131)的倾斜运动。
2.按照权利要求1的空心针器件，其中闭合件(131)具有沿周边的上述密封关系。
3.按照权利要求2的空心针器件，其中外壳(101)对柱塞(105)某种程度的压缩有助于上述密封关系。
4.按照权利要求2或3的空心针器件，其中闭合件(131)具有在其周边内偏心的上述局部移动接合。
5.按照权利要求2或3的空心针器件，其中闭合件(131)是刚性的，并且以首先倾斜运动方式而偏移时基本上不变形。
6.按照权利要求2或3的空心针器件，其中闭合件(131)具有一条环形槽(132)来配合柱塞(105)口附近的周向内肋(133)，另外容易从柱塞(105)口有间隙地通过柱塞(105)内部。
7.按照权利要求6的空心针器件，其中闭合件(131)是模制件，具有一条基本上离开上述环形槽(132)的模具分离线。
8.按照权利要求6的空心针器件，其中闭合件(131)是平的盘，直径小于上述肋(133)之外的柱塞(105)内部直径。
9.按照权利要求1的空心针器件，其中带针套(120)本身用于与闭合件(131)直接移动接合(135)。
10.按照权利要求9的空心针器件，其中套(120)和/或闭合件(131)具有一个构造(135)来保证在外壳(101)中上述柱塞(105)对内含物挤压行程结束时，上述移动接合为非对称。
11.按照权利要求10的空心针器件，其中带针套(120)和闭合件(131)的上述接合构造包括一个在与闭合件(131)偏心的位置上的局部突起(135)。
12.按照权利要求11的空心针器件，其中上述局部突起(135)与上述套(120)和/或上述闭合件(131)成整体。
CNB008162115A 1999-11-24 2000-11-23 空心针器件 Expired - Fee Related CN1173750C (zh)

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GBGB9927713.9A GB9927713D0 (en) 1999-11-24 1999-11-24 Hollow needle devices

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JP (1) JP4437197B2 (zh)
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AU (1) AU1533701A (zh)
CA (1) CA2389520C (zh)
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EP1291029A1 (en) * 2001-09-10 2003-03-12 Sergio Restelli Automatic safety syringe
EP1694390A4 (en) * 2003-12-16 2007-10-31 Von Pace Pty Ltd RETRACTABLE SYRINGE
MX2007004474A (es) * 2004-10-14 2007-08-08 Safety Medical International I Jeringa medica de seguridad con aguja removible.
KR20070108150A (ko) * 2004-12-14 2007-11-08 글로벌 메디세이프 홀딩스 리미티드 연장 가능한 자동 인입식 의료용 주사기
KR102421258B1 (ko) * 2020-04-28 2022-07-15 재단법인 아산사회복지재단 안전 주사기

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AT395679B (de) * 1988-10-13 1993-02-25 Pickhard Ewald Einwegspritze
GB9107647D0 (en) 1991-04-11 1991-05-29 Jeffrey Peter Syringe construction providing needle point protection
US5578011A (en) * 1995-05-11 1996-11-26 Shaw; Thomas J. Tamperproof retractable syringe
US5993417A (en) * 1998-01-06 1999-11-30 Yerfino; Daniel Alberto Disposable syringe with an automatically retractable hypodermic needle

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JP4437197B2 (ja) 2010-03-24
AU1533701A (en) 2001-06-04
GB9927713D0 (en) 2000-01-19
ES2232507T3 (es) 2005-06-01
EP1231962B1 (en) 2004-11-10
WO2001037902A2 (en) 2001-05-31
EP1231962A2 (en) 2002-08-21
CN1399568A (zh) 2003-02-26
PT1231962E (pt) 2005-03-31
DE60015787T2 (de) 2005-11-10
DE60015787D1 (de) 2004-12-16
CA2389520C (en) 2008-01-08
ATE281856T1 (de) 2004-11-15
JP2003514628A (ja) 2003-04-22
WO2001037902A3 (en) 2002-05-02
CA2389520A1 (en) 2001-05-31

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