CN100531815C - 带有在使用后针保护的自锁的一次性安全注射器 - Google Patents
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Abstract
本申请涉及带有在使用后针保护的自锁的一次性安全注射器领域。该注射器包括:空心针筒(1)终止于其带有内部针座(2)的较低边,该针座适于接收容纳插管(4)的针毂(3)。空心驱动杆(5),适于容纳弹簧(6),插入空心针筒内。该杆通过抽取元件(8)滑入空心驱动杆(5)在其低端闭合。抽取元件(8)具有容纳环形密封垫圈(10)的环形槽口(9),该垫圈密封空心针筒(1)的内壁。带有环形密封垫圈(10)的抽取元件(8)形成液体吸取和压缩的柱塞。
Description
技术领域
本发明涉及带有在使用后针保护的自锁的一次性安全注射器。
更具体地,它涉及一种注射器,在药物普通注射结束时,将其针回缩到其自身圆柱的空心柱塞内以保护医疗护理人员免受危险的意外针刺伤。
在使用后针应定位在使用者不能接近的位置,例如其自身空心柱塞内,限制地锁定该注射器使之不能使用。
背景技术
已知有多种类型的自锁式安全注射器,但本发明是指引用美国专利5,222,943A所描述的注射器类型,其提供空心注射器的针筒,该针筒终止于容纳针毂的内部针座,将插管(4)施放在针筒中。插管和针毂形成针。
在空心针筒内,用于医疗用途的橡胶垫圈滑动并装配在空心驱动杆的端部上。
在驱动杆腔内,装配可恢复弹簧。该弹簧在其一边与抽取器连接,该抽取器可通过贯穿橡胶垫圈的轴向孔,且该弹簧在另一边与在杆的自由端所施加的塞子相连。该抽取器装备有用于保持针管的针毂的钩形头部。
上述简单描述的注射器具有严重限制了它的应用三个主要缺点:
1)当吸取液体时,用于医疗用途的橡胶垫圈有允许外部空气(这些没有消毒)进入注射器内并与要注射的药物相接触的有限密封;
2)当为了用二次蒸馏水溶解药物,对粉状药物的小瓶的小橡胶塞穿孔时,对于穿透的针尖的必然结果是插管保持的针毂可从针筒的初始内部部分中的针座脱开/分开,使注射器完全不能用。
3)在注射结束时,有时,插管保持的针毂不能从其针筒的初始内部部分分开,从而防止针(即与插管一起的插管保持的针毂)缩回其自身空心驱动杆中。
第一个缺点是由于橡胶垫圈的形状和定位,橡胶垫圈具有允许带有可恢复弹簧的抽取元件穿过的中心孔,当它钩住插管保持的针毂,以在使用后将插管保持的针毂拖入空心驱动杆中。实际上,密封橡胶垫圈不能将带有可恢复弹簧的抽取元件夹得太紧,因为这将阻止抽取元件的滑动并且抽取元件的通道是将针带入空心柱塞驱动杆中必需的。
另外当吸取液体时在注射器内形成的低压使得与抽取元件邻接的橡胶垫圈的圆形边缘增大,从而促进空气的吸入并以此增加了这种麻烦。
第二个缺点是由于这样的事实,即插管保持的针毂作为柱塞被插入到内部圆柱形针座,并且只通过在两个塑料表面之间的简单干涉来使之保持。因此,例如在小瓶的小橡胶塞上的一个异常的针穿刺的结果是,由于错误的针穿透位置,使针毂从其内部针筒针座分开,在使用之前完全破坏了注射器。
第三个缺点是由于这样的事实,即在注射结束时,针不能总是缩回注射器的空心驱动杆中以保护医疗护理人员免受意的外针刺伤。实际上,由于只通过带有最小化的接触容许偏差的两个塑料表面之间的简单干涉来使插管保持的针毂保持在空心针筒的内部针座内,在生产两件式(用对注射成形的液压实施这种生产)时的小的错误就产生造成过大相互约束的分力。
由小弹簧的效率导致被过大约束的分力的分开,由于该弹簧自身的最大尺寸依赖于空心驱动杆的内部尺寸,因此不能增加弹簧的弹簧力。
除了上面提到的三个设计缺陷外,美国专利5,222,943A所公开的注射器还有进一步的缺陷,因为在使用其自锁安全系统中它不是传统的,这可误导最终使用者或医疗护理人员。
实际上,在注射结束时,为了将针缩回到其被保护的静止位置,必须使注射器柱塞产生两个连续的喀哒噪声。
第一喀哒声,已经提供用于滑动抽取元件的蘑菇形钩状头部必须被限制地进入带有插管保持的针毂的环形突起的凹槽。
第二喀哒声,不是自动的,而且需要更大的力挤压,在滑动抽取元件上的外围的台阶必须使在空心驱动杆内的台肩轴环变形并断裂,以使可恢复的弹簧缩回并拖动到其安全位置。
理论上,医疗护理人员将安全注射器作为普通的一次性注射器一样使用(在没有仔细阅读使用说明的情况下),在经历了第一喀哒声后,已经听到了噪声,并已确认针还保持在其操作位置,即还没有缩回,就不再执行(由于未被告知)使针进入其安全位置的第二个喀哒声。
以此,医疗护理人员危险地将保护帽放回到尖的针上而丢弃了断定其安全机构没有起作用的注射器。
发明内容
本发明的目的是去除使这种类型的自锁注射器不完全可靠的三个严重缺点,并简化安全机构的使用。
该目的全部由带有在使用后针保护的自锁的一次性安全注射器实现,本发明的主题将由下列的权利要求书提供。
附图说明
本发明的特征和优点可通过下面描述的所示优选实施例进一步指出,该实施例只是作为非限制性例子,在附图所附表中其中:
图1和1a分别示出在纵向截面准备使用的注射器和其放大部分;
图2和2a分别示出与图1和1a在同样截面的注射器,该注射器在其使用后,在其安全位置带有完全回缩的针;
图3示出注射器的分解透视图;
图4,4a和5,5a分别示出两个注射器部分,更细节地显示抽取元件和固定插管的针毂的透视图,纵向截面及前视图;
图6示出在放大的纵向截面视图中,为了指出某些部分而显示的注射器的局部;
图7和7a分别示出在纵向截面中空心的外部注射器针筒和其放大部分。
具体上述方式
参照附图,1标明一空心针筒,其在其顶部开口而在其底部终止于插入有针毂3的内部针座2。针毂3保持一插管4。
针毂和插管形成一针30,当不使用时,由帽29保护。在空心针筒1内,插入空心驱动杆5,该杆适于容纳弹簧6,该弹簧在杆内部通过密封塞子7和可在驱动杆5内滑动的抽取元件8保持张紧。
如图4和4a更清楚看到的,抽取元件8具有其中插入有环形保持垫圈10(O形环)的环形槽口9,该垫圈的尺寸为可在抽吸和压缩所要注射的液体时靠着空心针筒1的内壁密封。
因此,与相关的密封垫圈10(O形环)结合的抽取元件8作为抽吸和压缩柱塞操作。
抽取元件8进一步提供平面部分11,在其表面上插入用于针毂3的阴接合槽口12。针毂3(即为阳部件)在图5和5a更清楚地显示。
在抽取元件的外表面上,提供圆形止挡件13,其适于与空心驱动杆5的内前侧部分的圆形台阶14邻接。
参照图5和5a,载有插管4的针毂3适于提供用于在注射结束时进入阴接合槽口12的阳接合头部15。
接合头部15具有两个深的彼此正交的纵向的蚀刻口(etchings)16和17,以便插管保持的针毂在头部15和阳圆形底切18之间被切成四部分。
插管保持的针毂进一步具有截头锥形表面19,其适于执行与针座2的内表面上相对应的阴截头锥形表面20的密封。
参见图7和7a,在空心针筒1的较低的内部提供两个小的半圆形突起21和22,该突起可压靠滑动抽取元件的平面部分11并同时形成小的圆形凹槽23,该凹槽23用于容纳环形密封垫圈10,当注射结束时,垫圈10从其阴接合槽口移开,如下面将详细描述的。
针座2内表面在突起21和22下面提供阴环形沟槽或底切24,其适于容纳到圆形底切18。
现描述注射器的操作。吸取要注射液体的第一步由下述实现,即通过从空心针管1中抽取空心的柱塞,当内部注射器真空趋于在其操作位置外部沿针方向吸取液体时,载有密封垫圈,O形环的滑动抽取元件通过圆形止挡件13保持在正确位置,该止挡件13与空心驱动杆5前部分中的内侧设置的圆形台阶14邻接。
当注射液体时,当注射器内部压力趋于在其操作位置外部在空心驱动杆中使其回缩时,滑动抽取元件与密封垫圈,O形环一起通过密封垫圈自身保持在正确位置,该密封垫圈接合到抽取器并与空心驱动杆的前部分邻接。
通常装配插管保持的针毂时,将其推入空心注射器针筒1内其针座的内部,并只是部分地在两个塑性表面之间通过干涉保持。
这两个组件优选的是彼此结合成一体,以消除可能意外脱开的麻烦,因为插管保持的针毂上的阳圆形底切18接合在空心针筒1的针座2的内表面中的阴环形槽口24。
另外,在两个组件装配后,由于在两个底切18和24的两个定位高度(不得不向针尖方向稍微移动外部阴底切,以便保持相对的内部阳底切对它的施压)之间的小的但重要的区别,注射器液体保持容积在插管保持的针毂的阳平截头体19和阴平截头体20之间实现,该阴平截头体20形成在空心针筒1针座2内表面中,阳平截头体19和阴平截头体20通常保持相互受压。
在注射结束时,插管保持的针毂的阳接合头部15进入滑动抽取元件的阴接合槽口12。它的刺穿和接下来的接合通过深的纵向蚀刻口16和17变得就更容易,这样就允许该头部被限制并接着延伸以实现针毂与抽取元件的有效接合。
形成圆形凹槽23的两个半圆突起21和22容纳环形密封垫圈10,O形环,在注射结束时,从其自身的滑动抽取元件的环形槽口9移去以允许由弹簧推动的针返回其被保护的位置。
因为滑动抽取元件的阴接合槽口12的内径小于阳接合头15的直径,在注射结束时,在阴接合槽口内的阳接合头插入期间,由于其纵向蚀刻口使其有弹性,从而以这样的方式压迫该头部以使从其自身的阴圆形底切或环形沟槽24脱出阳圆形底切18。两个底切18和24的机械分离是通过挤压实现的,高度简化针抽取操作带来一系列好处,它可使用更软的弹簧6,有着更小的金属丝直径,并因此弹簧更软而发出喀哒声更小,并且还减少了费用。
另外,在注射结束时,通常两个小半圆突起21和22,为了实现容纳和保持密封垫圈,O形环,还使其自身在抽取元件的平面部分11上处于受压状态(通过对在带有密封环状垫圈的抽取元件的空心驱动杆上的操作者拇指推力的反应,形成真的注射器柱塞),以这样的方式容易地实现独立于弹簧力的针的抽取操作。
Claims (5)
1.一种带有在使用后针保护的自锁的一次性安全注射器,该注射器包括:空心针筒(1),在其下侧上终止于一内部针座(2),所述针座(2)适于接收载有插管(4)的针毂(3);适于容纳弹簧(6)的空心驱动杆(5)插入所述空心针筒内;该杆在其下端通过所述针毂(3)的抽取元件(8)相对于所述内部针座(2)闭合;所述抽取元件(8)可滑入到空心驱动杆(5)中,其特征在于,
所述抽取元件(8)具有容纳环形密封垫圈(10)的环形槽口(9);当注射器内部压力趋向于在其操作位置外部、在所述空心驱动杆(5)内部使其回缩时,所述滑动抽取元件(8)与环形密封垫圈(10)、O形环一起通过所述环形密封垫圈(10)自身保持在正确位置上,所述环形密封垫圈(10)接合到抽取器并且邻接所述空心驱动杆(5)的前部分;
所述空心针筒(1)在其下部分中具有两个半圆突起(21,22),所述两个半圆突起(21,22)适于形成圆形凹槽(23),所述凹槽(23)容纳所述环形密封垫圈(10),当注射结束时,所述环形密封垫圈(10)从所述抽取元件(8)上的其自身的所述环形槽口(9)上移离。
2.如权利要求1所述的注射器,其特征在于,所述抽取元件(8)提供一平面部分(11),在所述平面部分的表面上插入一阴接合槽口(12),用于所述针毂(3)的阳接合头部(15)。
3.如权利要求1所述的注射器,其特征在于,所述抽取元件(8)在其外表面上具有圆形止挡件(13),其适于邻接所述空心驱动杆(5)的内前部分中的圆形台阶(14)。
4.如权利要求2所述的注射器,其特征在于,所述阳接合头部(15)具有两个深的彼此正交的纵向蚀刻口(16,17)。
5.如权利要求1所述的注射器,其特征在于,所述针毂(3)具有阳圆形底切(18),其适于被插入到所述内部针座(2)的内表面中的阴环形底切或沟槽(24)中。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
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| ITPR2003A000105 | 2003-12-03 | ||
| IT000105A ITPR20030105A1 (it) | 2003-12-03 | 2003-12-03 | Siringa monouso auto-bloccante di sicuerezza con |
Publications (2)
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| CN1874816A CN1874816A (zh) | 2006-12-06 |
| CN100531815C true CN100531815C (zh) | 2009-08-26 |
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| EP (1) | EP1689472B1 (zh) |
| CN (1) | CN100531815C (zh) |
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| IT (1) | ITPR20030105A1 (zh) |
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| WO (1) | WO2005053779A1 (zh) |
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- 2004-11-10 BR BRPI0415749-4A patent/BRPI0415749A/pt not_active Application Discontinuation
- 2004-11-10 WO PCT/EP2004/012704 patent/WO2005053779A1/en not_active Ceased
- 2004-11-10 DE DE602004008506T patent/DE602004008506T2/de not_active Expired - Lifetime
- 2004-11-10 AT AT04797767T patent/ATE370757T1/de not_active IP Right Cessation
- 2004-11-10 MX MXPA06004718A patent/MXPA06004718A/es active IP Right Grant
- 2004-11-10 ES ES04797767T patent/ES2293358T3/es not_active Expired - Lifetime
- 2004-11-10 CN CNB2004800318729A patent/CN100531815C/zh not_active Expired - Fee Related
- 2004-11-16 US US10/988,696 patent/US7267664B2/en not_active Expired - Lifetime
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Also Published As
| Publication number | Publication date |
|---|---|
| WO2005053779A1 (en) | 2005-06-16 |
| US7267664B2 (en) | 2007-09-11 |
| DE602004008506D1 (de) | 2007-10-04 |
| MXPA06004718A (es) | 2006-07-05 |
| CN1874816A (zh) | 2006-12-06 |
| ES2293358T3 (es) | 2008-03-16 |
| US20050124934A1 (en) | 2005-06-09 |
| DE602004008506T2 (de) | 2008-05-15 |
| EP1689472B1 (en) | 2007-08-22 |
| BRPI0415749A (pt) | 2006-12-19 |
| ATE370757T1 (de) | 2007-09-15 |
| ITPR20030105A1 (it) | 2005-06-04 |
| EP1689472A1 (en) | 2006-08-16 |
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