CN113423447B - 预填充安全针管和注射器系统 - Google Patents
预填充安全针管和注射器系统 Download PDFInfo
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Abstract
针管和预填充注射器系统(10),可提供超低的药量浪费和自动针刺保护。在注射器组件(12)中预填充材料(15)。将针头组件(14)附接到注射器组件(12)。一间隔件(54)设置在针头组件(14)和注射器组件(12)之间。间隔件(54)具有中心开口(56)。针头组件(14)用针管基部(20)支撑针管(16)。在组装后,针管基部(20)通过间隔件(54)的中心开口(56)。针头组件(14)还包含可以选择性地覆盖针管(16)的安全滑动件(22)。在注射,压力和/或与柱塞头(52)的接触使得间隔件(54)接触并移动安全滑动件(22)。安全滑动件(22)在注射过程中移动以覆盖针管(16),在其中保持针管(16)安全。
Description
技术领域
总体上,本发明涉及预填充注射器,其用于通过针管或套管进行注射。更具体地,本发明涉及针管和注射器系统,其中针管自动在使用后被遮蔽。
背景技术
在美国每年进行数百万次注射。所述注射通常使用皮下注射针管和注射器进行。皮下注射针管的长度和针管的规格取决于具体应用以及注射是肌肉内注射、皮下注射、静脉内注射还是皮内注射。被注射的组合物也有很大的不同。许多药物组合物,例如某些基因治疗组合物,每次注射可以花费成千上万美元。因此,一毫升药物的一小部分可能价值数百美元。
一些药物组合物被制造为预填充注射器。也就是说,制造商将药物组合物的精确剂量装载到注射器中。所述注射器被密封并被送至医疗工作者处。医疗工作者将针头连接到预填充的注射器并对患者施用注射。当传统的针管用于执行注射时,在注射完成后,不可避免地会有一定体积的注射材料残留在针头内。因此,预填充注射器内含有的药量不会全部输送给患者。在注射之后,针头中剩余的药物材料被扔掉。如果考虑所有注射,这种浪费的药物材料累计达数十亿美元。
在现有技术中,很少考虑固有地保留在针头内的残留材料的体积。已经设计了一些针管和注射器组件使得其中注射器柱塞和针头进行平面接触。此种现有技术例如由授予Lee的专利号为6,616,636的美国专利和授予Jentzen的专利号为5,902,270的美国专利来说明。然而,在真实的医疗环境中,例如医院,取决于进行的注射,不同的预填充注射器与许多不同的针头一起使用。一些针头和注射器组合在排出药物组合物方面是高效的,而一些则不是。
当与预填充注射器一起使用的针头包含安全特征时,问题变得更加复杂。一些针头被设计为既可以进行注射,又可以提供某种机制以最大程度地减少针刺伤(needlestickinjury)的可能性。针刺伤在医疗工作者中很常见。针刺伤由美国国家职业安全和健康研究所(United States National Institute of Occupational Safety and Health)定义为由针管例如皮下注射针管、采血针管、静脉内(IV)管针管和用于连接IV递送系统的部件的针管引起的伤害。针刺伤可以传播经血液传播的病原体,如乙型肝炎病毒、丙型肝炎病毒和人体免疫缺陷病毒(HIV)。对于医疗工作者来说,针刺伤是在医疗工作人员中造成这些疾病的重要原因。
据疾病控制中心(Center for Disease Control)估计,在美国,每年有超过300万的医疗工作者由于针管事故暴露于血液和体液。大多数医疗工作者都接受过使用针管和处理用过的针管的程序培训。使用过的针管不应重新盖起(recapped)以防止针刺伤的可能性。然而,许多研究表明,在医疗工作者中,重新盖起仍然很普遍。
为了减少针刺伤的数量,已经开发了各种安全针管,这些安全针管起到在针管从皮肤缩回的瞬间覆盖针管的作用。这通常通过沿着针管的轴推进管状护套直到护套覆盖针管的尖端来实现。此种现有技术例如由授予Berler的专利号为6,626,863的美国专利、授予Berler的公开号为2007/0016140的美国专利、授予Berler的公开号为2007/0016145的美国专利和授予Berler的公开号为2008/0009808的美国专利来说明。然而,将安全机构集成在针头内通常会在针头内占用额外的空间。在针头中使用更多的空间意味着在针头中有更多的死区,残留的药物组合物可能在该死区中聚集。因此,在设计中经常存在必须平衡的互相对立的关注点。设计的安全特征与由于安全特征而保留的浪费的药物相平衡。
因此,需要一种改进的皮下注射针管和预填充注射器组件,其中在注射之后自动地遮蔽针管,并且其中组件不保留任何具有相当的体积的被注射材料。
如下面所述和要求保护的本发明满足了这种需求。
发明内容
本发明是一种针管和预填充注射器系统,其提供超低的药量浪费和自动针刺保护。提供了一种注射器组件,其包含注射器针筒和柱塞。注射器针筒预填充满注射材料。柱塞具有柱塞头,该柱塞头在针筒中移动,并且可用于将注射材料移动到注射器针筒的开口端。
针头组件在使用之前附接到注射器组件。间隔件设置在针头组件和注射器组件之间。间隔件具有延伸穿过所述间隔件的中心开口。
针头组件支撑有针管基部的针管。针头组件在注射器针筒的开口端上附接到注射器针筒。当组装时,针管基部通过间隔件的中心开口。针头组件还包含可以选择性地覆盖针管的安全滑动件。在注射期间,与柱塞头的压力和/或接触导致间隔件接触并移动安全滑动件。这样,安全滑动件在注射过程中移动以覆盖针管,直至在注射过程完成之前保持针管安全。
附图说明
为了更好地理解本发明,参考结合附图考虑的本发明的示例性实施例的以下描述,其中:
图1是安全针管和注射器系统的一个示例性实施例的横截面视图,该安全针管和注射器系统包含附接到针头组件的注射器组件;
图2示出了图1的示例性实施例的一个分解图;
图3示出了针头组件的安全滑动件的一个立体图;
图4是在致动针头组件中的安全滑动件之前注射器组件和针头组件的颈部的一个放大的横截面视图;
图5是在致动针头组件中的安全滑动件期间注射器组件和针头组件的颈部的一个放大的横截面视图;
图6是在致动针头组件中的安全滑动件之后注射器组件和针头组件的颈部的一个放大横的截面视图;以及
图7是针管和预填充注射器组件的一个替代实施例的剖视图。
具体实施方式
本发明的针管和注射器系统可以以多种方式配置并且可以适于在多种应用中使用。然而,为描述和图示的目的仅选择一些示例性实施例。另外,当解释所附权利要求的范围时,所示的实施例仅仅是示例性的,并且不应被认为是限制。
参照图1、图2和图3,示出了本发明的针管和注射器系统10。在所示实施例中,针管和注射器系统10包括两个主组件,这两个主组件在使用之前由医疗专业人员选择性地接合。所述两个主组件包括预填充注射器组件12和针头组件14。
预填充注射器组件12包含在预填充注射器组件12内密封的一定体积的注射材料15。当针头组件14附接到预填充注射器组件12时,针头组件14刺穿预填充的注射器组件12并在注射材料15和皮下注射针管16之间提供流动路径。如将更详细地解释的,针管16被护套管30围绕。在注射过程中,护套管30在针管16上方推进,其中直至在从患者撤回针管16之前保持针管16的安全。因此,针管16在开始注射过程之前暴露(图1)并在注射过程结束时被覆盖(图2)。
参考图4、图5结合图3,将可以理解的是,针头组件14保持针管16。针管16具有尖锐的第一端18和相对的第二端19。两端18、19沿相反方向从针头组件14突出。针管16的规格和针管16的长度由医疗专业人员针对正在执行的医疗过程来选择。在针头组件14内,针管16的一部分设置在细长基部20内。细长基部20是管状的并且不阻碍通过针管16的流动。这样,针管16和细长基部20作为单个单元一起移动。如图所示,针管16的第二端19可以以与细长基部20的相同点终止。然而,为了降低成本,针管16可以在细长基部20内终止,并且细长基部20可以继续沿与针管16相同的方向延伸到突出点。
针头组件14包括套环34和安全滑动件22。针管16的细长基部20附接到套环34。这样,在注射期间,套环34、针管16和细长基部20之间没有相对运动。套环34用卡口连接、螺纹连接或类似的机械连接地机械地连接到预填充的注射器组件12。这样,套环34用于将针头组件14与预填充的注射器组件12互相连接。套环34具有内部脊35,其目的在后面描述。
安全滑动件22位于套环34内,其中安全滑动件22围绕针管16和细长基部20的截面。安全滑动件22相对于针管16和套环34移动,其中针管16和套环34引导安全滑动件22的运动。
安全滑动件22具有管状本体24。支腿26从管状本体24的第一端27延伸。锁定突起38从支腿26沿径向延伸,其目的将在后面描述。管状本体24限定了中心腔28,该中心腔28的尺寸设置成接收针管16的细长基部20。护套管30从与支腿26相对的安全滑动件22的第二端31延伸。延伸的护套管30是悬臂式(cantilevered)的,并限定与中心腔28连通的通路。细长基部20延伸到安全滑动件22的中心腔28中,并且针管16延伸穿过安全滑动件22的护套管30。如以下将会解释的,安全滑动件22能够相对于针管16和细长基部20移动。
预填充的注射器组件12具有针筒40。针筒40限定管状腔室41,该管状腔室41在开放的第一端42和开放的第二端44之间延伸。针筒40可以是玻璃或塑料。在所示实施例中,针筒40具有螺纹颈部47。这样,针筒40的内径在向螺纹颈部47的过渡处减小。螺纹颈部47以螺纹接合或以其他方式构造成被针头组件14的套环34接合。同样地,针筒40的外部在相对的第二端44处具有指部凸缘46,以便于正确地握持预填充注射器组件12。
柱塞50设置在针筒40内。柱塞50具有柱塞头52,当柱塞50在针筒40内往复运动时,柱塞头52密封针筒40内的管状腔室41。柱塞头52比针筒40的螺纹颈部47宽,并且不能进入螺纹颈部47。柱塞头52具有面向针筒40的开放的第一端42的端面55。
管状间隔件54定位在针筒40的管状腔室41内。管状间隔件54具有在第一端57和第二端58之间延伸的中心开口56。管状间隔件54具有窄部63和放大的基部64。放大的基部64具有与柱塞头52相同的直径,并以相同的方式靠在针筒40内的管状腔室41上。这样,流体只能通过流过延伸穿过管状间隔件54的中心开口56而通过针筒40内的管状间隔件54。管状间隔件54的第一端57朝向柱塞头52的端面55定向。管状间隔件54的第一端57构造成抵靠柱塞头52,而没有介入间隙空间。在相对的第二端58处,管状间隔件54中的中心开口56的尺寸被设置为能够在针管16的底部接收细长基部20。
管状间隔件54定位在针筒40的管状腔室41内。最初,管状间隔件54的第二端58与针筒40的开放的第一端42齐平。管状间隔件54的放大的基部64在针筒40内形成为密封。将一定体积的注射材料15加入针筒40中,其中注射材料15位于柱塞头52和管状间隔件54之间。当柱塞头52在针筒40内前进时,用于注射材料15的唯一出口是通过管状间隔件54的中心开口56。设置密封盖67,其密封管状间隔件54的中心开口56和针筒40的第一开口端42。因此,在使用之前,应当理解,注射材料62和管状间隔件54都密封在针筒40内。
参考图6接合图4和图5,可以理解的是,当针头组件14附接到预填充注射器组件12时,针管16的第二端19和/或针管16的细长基部20刺穿预填充的注射器组件12的密封盖67。这在作为针头组件14的套环34附接到针筒40的螺纹颈部47时发生。当密封盖67被刺穿时,针管16的细长基部20通过管状间隔件54的中心开口56。细长基部20通过过盈配合进入管状间隔件54,从而在细长基部20和管状间隔件54之间形成不透液的密封。结果,注射材料15的唯一出口通过管状间隔件54的中心开口56并通过针管16。
应当理解,为了利用针管和注射器系统10,要选择适合于待执行的医疗注射的针头组件14和注射器组件12。针头组件14手动附接到预填充的注射器组件12。精确的注射材料15容纳在预填充的注射器组件12内。
在使用之前,暴露针管16的尖锐的第一端18。针管16的第一端18用于通过患者的皮肤进行注射。由于护套管30的细度,护套管30通常也通过由针管16形成的开口进入皮肤。通过朝向针头组件14推动柱塞头52来注入注射材料62。依次参照图5和图6,针管16和细长基部20在注射前、注射期间和注射之后静止。细长基部20部分地延伸到管状间隔件54的中心开口56中。以这种方式,流过针管16的注射材料15可以自由地流过管状间隔件54。
当柱塞50进入针筒40时,注射材料15通过针管16从针筒40移出。当柱塞头52最初接触管状间隔件54时,柱塞头52和管状间隔件54之间没有间隙空间。包含注射组合物62的唯一区域位于针管16内部以及在管状间隔件54的中心开口56中的未被针管16的细长基部20占据的部分。然而,此时,柱塞50还没有完全压入针筒40内。
参考图6,可以看出,随着柱塞50前进,注射材料的压力开始将管状间隔件54推入针头组件14中。在注射过程的结尾,柱塞头52接触并直接推动管状间隔件54。此时,管状间隔件54内的开放空间很小。注射材料15可以保留的唯一区域在针管16本身内。这个区域很小。其结果是浪费的注射材料15非常少,并且在预填充的注射器组件12内包含的注射材料15的几乎所有体积在注射过程中均被排出。
当管状间隔件54被柱塞头52推出针筒40时,管状间隔件54压靠在安全滑动件22的支腿26上。结果,安全滑动件22被推动并在周围的套环34内向前移动。当安全滑动件22向前移动时,护套管30在针管16上前进,其中护套管30最终延伸超过针管16的尖锐的第一端18。在注射过程中发生安全滑动件22的移动。通常发生在注射完成之前,护套管30超过针管16的尖端。这样,当针管16从皮肤缩回时,针管16已经被护套管30覆盖。这使得针管16安全。
当安全滑动件22在固定套环34内前进时,安全滑动件22的支腿26上的锁定突起38移动经过并将内部脊35接合在套环34的内部。这防止针头组件14被复位和重新使用。另外,随着安全滑动件22在套环34内前进,安全滑动件22外部上的可视指示器65(图3)变得可见。当安全滑动件22与套环34锁定接合时,可视指示器65变得可见。可视指示器65使医疗工作者能够清楚针管和注射器系统10已经被使用,并且系统10被锁定在安全配置中且等待废弃。
鉴于上述情况,将可以理解:
在使用之前,安全滑动件22缩回,并且针管16延伸超过护套管30,在此处针管16可被使用。在使用期间,安全滑动件22令护套管30沿针管16前进以覆盖针管16。在使用之后,安全滑动件22完全延伸,并且护套管30完全覆盖针管16,这使得针管16安全。
在图1及图6所示的实施例中,针管和预填充的注射器系统10用狭窄的螺纹颈部47施加到注射器针筒40上。这对于玻璃注射器针筒是典型的。然而,对于塑料注射器针筒而言,针筒通常在两末端之间具有恒定的直径。参考图7,示出了预填充的注射器组件70,其具有直径恒定的针筒72。环形突起74形成在针筒72中的与其开口端76有较短距离处。弹性密封件78放置在针筒72中,其中弹性密封件78搁置在环形突起74上。弹性密封件78受到突出盖79的保护。
提供针头组件80,其与先前描述的相同。然而,在该实施例中,管状间隔件82位于针头组件80内而不是在预填充的注射器组件70中。当针头组件80附接到预填充注射器组件70时,针头组件80刺穿预填充的注射器组件70的弹性密封件78。一旦柱塞84移动,弹性密封件78就会抵靠管状间隔件82,并且两个部件作为单个元件动作。然后,管状间隔件82以与前述第一实施例所述的方式相同的方式激活在针头组件80中的安全特征。
应当理解,示出和描述的本发明的实施例仅仅是示例性的,并且本领域技术人员可以对这些实施例进行多种改变。所有这些实施例旨在包括由权利要求限定的本发明的范围内。
Claims (18)
1.一种针管和注射器系统(10),包括:
预填充注射材料(15)的注射器针筒(40),其中所述注射器针筒(40)具有第一开口端(42);具有柱塞头(52)的柱塞(50),所述柱塞(50)可以在所述注射器针筒(40)内往复移动,其中所述柱塞头(52)具有端面(55),所述端面(55)面向所述注射器针筒(40)内的所述注射材料(15);
设置在所述注射器针筒(40)中的分离的间隔件(54),所述间隔件(54)具有延伸穿过所述间隔件(54)的中心开口(56)和接触表面(57),所述接触表面(57)面向所述注射器针筒(40)内的所述注射材料(15),其中当所述柱塞(50)在所述注射器针筒(40)中前进时,所述柱塞头(52)接触并移动所述间隔件(54);
封闭所述注射器针筒(40)的所述第一开口端(42)的密封件(67),其中所述注射材料(15)和所述间隔件(54)介于所述柱塞头(52)和所述密封件(67)之间并插入在所述注射器针筒(40)内;
支撑针管(16)的针头组件(14),其中所述针头组件(14)在所述第一开口端(42)上选择性地附接到所述注射器针筒(40),并且其中所述针头组件(14)刺穿所述密封件(67)并与所述间隔件(54)互相连接,使得所述间隔件(54)的所述中心开口(56)与所述针管(16)对齐。
2.根据权利要求1所述的系统,其特征在于,所述针头组件(14)包括支撑所述针管(16)的针管基部(20)和选择性地连接到所述注射器针筒(40)的套环(34),所述针管基部(20)附接在所述套环(34)上。
3.根据权利要求2所述的系统,其特征在于,当所述套环(34)连接到所述注射器针筒(40)时,所述针管基部(20)延伸到所述间隔件(54)的所述中心开口(56)中。
4.根据权利要求3所述的系统,其特征在于,所述针管(16)在尖锐的第一端(18)和相对的第二端(19)之间延伸,其中随着所述针头组件(14)附接到所述注射器针筒(40),所述针管(16)的所述第二端(19)刺穿所述密封件(67)。
5.根据权利要求2所述的系统,还包括具有护套管(30)的安全滑动件(22),所述护套管(30)围绕所述针管(16)的一部分,并且其中所述安全滑动件(22)可以相对于所述针管(16)和套环(34)在第一位置和第二位置之间移动,在所述第一位置时所述护套管(30)仅覆盖所述针管(16)的一部分,在所述第二位置时所述护套管(30)完全覆盖所述针管(16)。
6.根据权利要求5所述的系统,其特征在于,当所述柱塞(50)在所述注射器针筒(40)中前进时,所述柱塞头(52)接触并移动所述间隔件(54),所述间隔件(54)前进并超过所述针管基部(20),且所述安全滑动件(22)从所述第一位置移动到所述第二位置。
7.根据权利要求6所述的系统,其特征在于,当所述安全滑动件(22)从所述第一位置移动到所述第二位置时,所述针管基部(20)通过所述间隔件(54)中的所述中心开口(56)移动到所述间隔件(54)的所述接触表面(57)。
8.根据权利要求1的系统,其中所述间隔件(54)的所述接触表面(57)和所述柱塞头(52)的所述端面(55)相配,使得在所述接触表面(57)和所述端面(55)接触时,在所述接触表面(57)和所述端面(55)之间不存在空间。
9.根据权利要求5所述的系统,进一步包括锁,当所述安全滑动件(22)进入所述第二位置时,所述锁将所述安全滑动件(22)自动锁定在所述第二位置。
10.根据权利要求9所述的系统,进一步包括在所述安全滑动件(22)上的可视指示器(65),所述可视指示器(65)在所述安全滑动件(22)进入所述第二位置时变得可见。
11.一种针管和注射器系统(10),包括:
包含注射器针筒(40)、柱塞(50)和密封件(67)的预填充注射器组件(12),其中,所述柱塞(50)具有柱塞头(52),并且其中注射材料(15)在所述柱塞头(52)和所述密封件(67)之间保持在所述注射器针筒(40)中;
选择性地附接到所述预填充注射器组件(12)的针头(14),其中所述针头(14)支撑带有尖锐的端部(18)和针管基部(20)的针管(16);
设置在所述针头(14)中的分离的管状间隔件(54),其中所述间隔件(54)具有穿过所述间隔件(54)中延伸的中心开口(56),其中所述针管基部(20)延伸穿过所述中心开口(56),其中当所述柱塞(50)在所述注射器针筒(40)中前进时,所述柱塞头(52)移动所述间隔件(54)。
12.根据权利要求11所述的系统,还包括具有护套管(30)的安全滑动件(22),所述护套管(30)围绕所述针管(16)的一部分,并且其中所述安全滑动件(22)能够相对于所述针管(16)在第一位置和第二位置之间移动,在所述第一位置,所述护套管(30)不延伸超过所述针管(16)的所述尖锐的端部(18),在所述第二位置,所述护套管(30)延伸超过所述针管(16)的所述尖锐的端部(18)。
13.根据权利要求12所述的系统,其特征在于,当所述柱塞(50)在所述注射器针筒(40)中前进时,所述柱塞头(52)移动所述间隔件(54),且所述间隔件(54)将所述安全滑动件(22)从所述第一位置移动到所述第二位置。
14.根据权利要求11所述的系统,其特征在于,在所述针头(14)附接到所述注射器针筒(40)时,所述针头(14)刺穿所述密封件(67)。
15.根据权利要求11所述的系统,其中所述间隔件(54)和所述柱塞头(52)相配合,从而在所述间隔件(54)和所述柱塞头(52)接触时,在所述间隔件(54)和所述柱塞头(52)之间不存在空间。
16.根据权利要求13所述的系统,其特征在于,随着所述安全滑动件(22)进入所述第二位置,所述安全滑动件(22)锁定到所述第二位置。
17.根据权利要求16所述的系统,进一步包括在所述安全滑动件(22)上的可视指示器(65),所述可视指示器(65)在所述安全滑动件(22)进入所述第二位置时变得可视。
18.根据权利要求11所述的系统,其中所述针头(14)包括套环(34),所述套环(34)选择性地接合所述注射器针筒(40)。
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US16/660,784 | 2019-10-22 | ||
US16/660,784 US11154663B2 (en) | 2018-10-25 | 2019-10-22 | Pre-filled safety needle and syringe system |
PCT/US2019/057968 WO2020086917A1 (en) | 2018-10-25 | 2019-10-24 | Pre-filled safety needle and syringe system |
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CN113423447A CN113423447A (zh) | 2021-09-21 |
CN113423447B true CN113423447B (zh) | 2024-04-23 |
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US (1) | US11154663B2 (zh) |
EP (1) | EP3870253A4 (zh) |
JP (1) | JP7432096B2 (zh) |
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CN (1) | CN113423447B (zh) |
AR (1) | AR119660A1 (zh) |
AU (1) | AU2019363601B2 (zh) |
BR (1) | BR112021007848A2 (zh) |
CA (1) | CA3117217C (zh) |
IL (1) | IL282418B (zh) |
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US11154663B2 (en) | 2021-10-26 |
AU2019363601A1 (en) | 2021-06-03 |
JP2022509364A (ja) | 2022-01-20 |
CA3117217C (en) | 2024-04-09 |
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EP3870253A1 (en) | 2021-09-01 |
EP3870253A4 (en) | 2022-08-17 |
US20200129707A1 (en) | 2020-04-30 |
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