CN114126684A - 用于低剂量注射的超低废物一次性安全注射器 - Google Patents
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Abstract
一种针和注射器系统(10),其中针头(12)附接到注射器组件(14)。注射器组件(14)包括注射器筒(16)和具有柱塞头(20)的柱塞杆(18)。针座(26)固定到注射器筒(16)。管状空腔(40)形成在针座(26)中,柱(44)延伸穿过管状空腔(40)。针(24)延伸穿过柱(44)。提供间隔件(46),当柱塞头(20)前进时,该间隔件移位到管状空腔(40)中。设置有围绕针座(26)的保护罩(52)。当间隔件(46)移位时,间隔件(46)在第一位置和第二位置之间移动保护罩(52)。当保护罩(52)移动时,其围绕针(24)并防止针(24)造成伤害。
Description
技术领域
大体上,本发明涉及用于通过针或插管进行注射的注射器。更具体地,本发明涉及安全注射器,该安全注射器被设计成在使用之后屏蔽针,并且在使用注射器之后将保留在注射器内的注射材料的量最小化。
背景技术
医护人员每年进行数百万次注射。注射通常使用皮下针和注射器进行。皮下针的长度和针的规格取决于应用以及注射是肌内、皮下、静脉内还是皮内。注射的化合物也变化很大。一些注射材料如盐水是非常便宜的。然而,许多药物化合物,例如某些基因治疗化合物,每次注射可能花费数万美元。因此,一毫升这种药物的一小部分可能价值数百美元。
当传统的皮下针和注射器用于执行注射时,在注射完成之后不可避免地存在一定体积的注射材料保留在针和注射器内。注射后,剩余的药物材料与针和注射器一起扔掉。考虑到所有的注射,这些浪费的药物材料加起来就浪费了数十亿美元的药物。
在现有技术中,很少考虑固有地保留在皮下注射器和针内的残余材料的体积。已经设计了一些针和注射器组件,其中注射器柱塞和针头齐平接触。这种现有技术的设计由美国专利US6,616,636(Lee)和US5,902,270(Jentzen)示例性示出。然而,在诸如医院的真实医疗环境中,取决于具体的医疗应用,不同的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化合物方面是有效的,而有些则不是。
当针头和注射器是安全注射器组件的一部分时,问题变得更加复杂。安全注射器组件被设计成既执行注射又提供某种机构以最小化针刺伤的可能性。针刺伤在医护人员中很常见。针刺伤由美国国家职业安全卫生研究所定义为:由诸如皮下针、采血针、静脉(IV)管心针和用于连接IV递送系统的各部件的针等针引起的损伤。针刺伤可传递血源性病原体,如乙型肝炎病毒、丙型肝炎病毒、人类免疫缺陷病毒(HIV)和新冠肺炎。对于医护人员来说,针刺伤是医护人员中这些疾病的重要原因。
美国疾病控制中心(Centers for Disease Control)估计,在美国,每年有超过300万医护人员通过针头事故接触血液和体液。大多数医护人员都接受过使用和处理用过的针头的流程培训。例如,不应重新盖针头,以防止针刺伤的可能性。然而,许多研究表明,重新盖在医护人员中仍然很普遍。
为了减少针刺伤的次数,已经开发出各种安全针,用于在针从皮肤缩回的瞬间自动覆盖针。这通常通过沿着针的轴推进管状护套直到护套覆盖针的尖端来实现。这样的现有技术被美国专利/专利申请US6,626,863,US2007/0016140,US2007/0016145,US2008/009808示例性示出。然而,在针头内集成安全机构通常在针头内占用额外的空间。针头中更大的空间意味着针头中有更多的死区,残留的药物化合物可能会被收集在那里。因此,一项设计中经常存在必须平衡的对立的方面。设计的安全性与由于安全性而保留的废弃药物相平衡。
因此,需要一种改进的皮下针和注射器组件,其中针在注射后被自动屏蔽,并且其中该组件不保持任何显著体积的被注射材料。如下描述和要求保护的本发明满足了这种需要。
发明内容
本发明是一种针和注射器系统,其中针头附接到注射器组件。注射器组件包括注射器筒。柱塞杆设置有柱塞头,该柱塞头可在注射器筒内往复运动。
针座固定在注射器筒上。针座在沿中心轴线的相对点处具有第一端和第二端。管状空腔形成在针座中,并且柱延伸穿过管状空腔。管状空腔可从针座的第一端进入。
针沿着中心轴线延伸到针座中。针延伸穿过柱并且在针座的第一端开口以接收注射器筒的内容物。提供了间隔件。当柱塞头在注射器筒管内前进时,间隔件移位到针座内的管状空腔中。
所述针座周围设置有保护罩。当间隔件移位到管状空腔中时,间隔件在第一位置和第二位置之间移动保护罩。当保护罩在位置之间移动时,保护罩围绕针并防止针引起任何意外的针刺伤。
附图说明
为了更好地理解本发明,结合附图,参考下面对本发明的示例性实施例的描述,其中:
图1示出了示例性的针和注射器系统的处于准备使用状态的头部,其中头部的针暴露;
图2是图1的实施例的剖视图;
图3示出了示例性实施例的爆炸图;
图4是示例性实施例的剖视图,其中针部分地被保护罩覆盖;
图5是示例性实施例的剖视图,其中针完全地被保护罩覆盖。
具体实施方式
本发明的针和注射器系统可以以多种方式构造,并且可以适于在许多应用中使用。然而,仅选择一个示例性实施例以进行描述和说明。然而,示出的实施例仅仅是示例性的,并且在解释所附权利要求的范围时不应当认为是限制。
参照图1、图2和图3,示出了本发明的针和注射器系统10。在所示的实施例中,针和注射器系统10包括选择性地连接的两个主要的子组件。主要的子组件包括头部子组件12和注射器子组件14。头部子组件12通过机械连接机械地接合注射器子组件14,或者可以使用粘合剂或塑料焊接结合到注射器子组件14。不管怎样,注射器子组件14和头部子组件12之间的连接是流体不可渗透的。
注射器子组件14包括注射器筒16和延伸到注射器筒16中的柱塞杆18。柱塞杆18可手动地穿过注射器筒16朝向头部子组件12推进。柱塞杆18终止于弹性体的活塞头20。当柱塞杆18在注射器筒16内移动时,弹性体的活塞头20密封注射器筒16的内部。活塞头20具有平坦的前表面22,其面向注射器筒16中的活塞头20。
头部子组件12保持针24。针24由塑料的针座26支撑在头部子组件12中。针座26具有复杂的形状。针座26围绕中心轴线28对称地形成,其中针24与中心轴线28对准。沿着中心轴线28,针座26具有第一端30和相对的第二端32。针座26的第一端30延伸到注射器筒16中并面向活塞头20。
在针座26的外部靠近第一端30形成凸缘34。凸缘34机械地连接或粘附到注射器筒16。这将针座26连接到注射器筒16。在针座26的外部形成有两个锁定凹部36、38。第一锁定凹部36位于针座26的第一端30附近,第二锁定凹部38位于针座26的第二端32附近。
在针座26的第一端30中形成管状空腔40。管状空腔40可通过两个侧槽42进入,两个侧槽42形成在针座26的相对侧中。槽42从凸缘34延伸到管状空腔40的远端。管状空腔40也可从注射器筒16内进入。管状空腔40在针座26内形成中心柱44,其中中心柱44与中心轴线28同心。针24延伸穿过中心柱44,使得针24能够获取注射器筒16的内容物。中心柱44具有比管状空腔40的长度更长的长度。结果,中心柱44部分地延伸到注射器筒16中。
设置有环形间隔件46和致动环48。在所示的实施例中,环形间隔件46和致动环48被示出为单独的部件。这是可选的构造。环形间隔件46和致动环48可模制为一体件。在所示的两件式结构中,环形间隔件46是管状的,其内径和外径使得环形间隔件46能够装配在针座26的管状空腔40内。致动环48具有环形主体49和从环形主体49向外延伸的两个径向支撑件50。环形主体49具有与环形间隔件46相同的内径和外径。径向支撑件50足够宽以延伸到针座26的侧槽42中。环形间隔件46和致动环48的结合长度与中心柱44的长度完全相同。环形间隔件46和致动环48可沿中心柱44的长度自由滑动,这受到径向支撑件50在侧槽42中的运动的限制。
头部子组件12包括位于针座26上的适当位置的保护罩52。保护罩52具有围绕针24的一部分的安全护套54。保护罩52可沿针座26的外部往复运动。然而,保护罩52包含向内延伸的锁定凸起56,该锁定凸起56可接合针座26外部上的锁定凹部36、38。当锁定凸起56移动到锁定凹部36、38中的一个中时,保护罩52被偏置到设定位置。
在使用之前,头部子组件12具有图2所示的构造。结合图3参考图4和图5,可以看出,在使用之前,注射器筒16以传统方式填充药物55。在该第一位置,注射器筒16充满,并且保护罩52上的锁定凸起56接合针座26上的第一锁定凹部36。这防止在拿持针和注射器系统10时发生任何意外排出。当柱塞杆18被手动推进时,锁定凸起56可从第一锁定凹部36移位。当活塞头20朝向头部子组件12推进时,活塞头20接触环形间隔件46并将环形间隔件46和致动环48压入围绕针座26的中心柱44的管状空腔40中。当活塞头20接触中心柱44时,环形间隔件46和致动环48完全填充管状空腔40。除了保留在针24内的非常少量的药物之外,所有药物都从注射器子组件14移出。在该第二位置,锁定凸起56接合针座26上的第二锁定凹部38。
当柱塞杆18前进时,柱塞杆17接触并移动环形间隔件46。环形间隔件46移动致动环48。致动环48上的径向支撑件50延伸到保护罩52中的侧槽42中。当致动环48被前进的环形间隔件46向前按压时,径向支撑件50在针座26上向前移动保护罩52。随着防护罩52向前移动,安全护套54也向前移动,其中安全护套54覆盖针24的尖端。致动环48和径向支撑件50在注射期间沿着针24移动。结果,安全护套54在注射期间也向前移动。当注射完成时,安全护套54完全前进并且针24被完全屏蔽。结果,在注射之后,医护人员没有机会接触针24的尖端。
彩色指示器60可设置在针座26的外部,以提供针和注射器系统10已经从其完全的第一位置移动到其排出的第二位置的彩色编码指示。
应当理解,本发明的示出和描述的实施例仅仅是示例性的,本领域技术人员可以对该实施例做出许多变化。所有这些实施例都被包括在由所附权利要求限定的本发明的范围内。
Claims (20)
1.一种针和注射器系统,包括:
注射器筒;
柱塞杆,所述柱塞杆具有能够在所述注射器筒内往复运动的柱塞头;
固定到所述注射器筒的针座,所述针座具有延伸到所述注射器筒中的第一端和延伸超过所述注射器筒的远侧的第二端,其中在所述针座中形成空腔,所述空腔可从所述注射器筒内进入并穿过形成在所述针座中的所述第一端和所述第二端之间的槽;
从所述空腔内延伸穿过所述槽的支撑件;
保护罩,所述保护罩围绕所述针座并接触所述支撑件;
其中,当在所述注射器筒中推进所述柱塞杆时,所述柱塞头在所述空腔中推进所述支撑件,并且所述支撑件将所述保护罩从第一位置移动到第二位置。
2.根据权利要求1所述的系统,其中当所述保护罩处于所述第二位置时,当针被所述保护罩保护时,所述针从所述针座的所述第二端延伸。
3.根据权利要求1所述的系统,其中所述支撑件从设置在所述空腔内的致动环延伸。
4.根据权利要求3所述的系统,还包括设置在所述空腔中的间隔件,其中所述柱塞头移动所述间隔件,所述间隔件移动所述致动环。
5.根据权利要求4所述的系统,其中所述空腔具有从所述针座的所述第一端朝向所述针座的所述第二端的长度,其中所述间隔件和所述致动环具有等于所述空腔的所述长度的结合长度。
6.根据权利要求1所述的系统,其中所述针座和所述保护罩具有凸起和多个凹部,所述凸起和多个凹部接合并用于将所述保护罩保持在所述第一位置和所述第二位置。
7.根据权利要求2所述的系统,其中所述针座包括延伸穿过所述空腔的中心柱,其中所述中心柱和所述空腔同心。
8.根据权利要求7所述的系统,其中所述针延伸穿过所述中心柱。
9.一种针和注射器系统,包括:
注射器筒;
柱塞杆,所述柱塞杆具有能够在所述注射器筒内往复运动的柱塞头;
针座,所述针座固定到所述注射器筒,所述针座在沿中心轴线的相对点处具有第一端和第二端,其中空腔形成在所述针座中并且柱延伸穿过所述空腔,其中所述空腔可从所述针座的所述第一端进入,并且所述空腔和所述柱均与所述中心轴线同心;
针,所述针沿着所述中心轴线延伸到所述针座中,其中所述针延伸穿过所述柱并且在所述针座的所述第一端处开口;
间隔件,当在所述注射器筒中推进所述柱塞头时,所述间隔件移位到所述针座内的所述空腔中;以及
围绕所述针座设置的保护罩,其中,当所述间隔件移位到所述空腔中时,所述间隔件在第一位置和第二位置之间移动所述保护罩。
10.根据权利要求9所述的系统,其中槽形成在所述针座中,所述槽提供进入所述空腔的通道。
11.根据权利要求10所述的系统,还包括从所述空腔内延伸穿过所述槽的支撑件,其中所述支撑件由所述间隔件移动。
12.根据权利要求11所述的系统,其中所述保护罩接触所述支撑件,并通过所述支撑件在所述第一位置和所述第二位置之间移动。
13.根据权利要求9所述的系统,其中所述支撑件从设置在所述空腔内的致动环延伸。
14.根据权利要求13所述的系统,其中所述柱塞头移动所述间隔件,所述间隔件移动所述致动环。
15.根据权利要求14所述的系统,其中所述空腔具有从所述针座的所述第一端朝向所述针座的所述第二端的长度,其中所述间隔件和所述致动环具有等于所述空腔的所述长度的结合长度。
16.根据权利要求9所述的系统,其中所述针座和所述保护罩具有凸起和多个凹部,所述凸起和多个凹部接合并用于将所述保护罩保持在所述第一位置和所述第二位置。
17.一种针和注射器系统,包括:
注射器筒;
柱塞杆,所述柱塞杆具有能够在所述注射器筒内往复运动的柱塞头;
固定到所述注射器筒的开槽针座,所述开槽针座具有槽、面向所述注射器筒的第一端和背向所述注射器筒的远侧的第二端,其中在所述针座中形成可从所述注射器筒内进入的空腔;
从所述空腔内延伸穿过所述槽的支撑件;
保护罩,所述保护罩围绕所述针座,其中所述保护罩通过所述支撑件在所述槽中的移动而移动;
其中,当在所述注射器筒中推进所述柱塞杆时,所述柱塞头使所述支撑件前进到所述空腔中,并且所述支撑件将所述保护罩从第一位置移动到第二位置。
18.根据权利要求17所述的系统,其中当所述保护罩处于所述第二位置时,当针被所述保护罩保护时,所述针从所述针座的所述第二端延伸。
19.根据权利要求17所述的系统,其中所述支撑件从设置在所述空腔内的致动环延伸。
20.根据权利要求19所述的系统,还包括设置在所述空腔中的间隔件,其中所述柱塞头移动所述间隔件,所述间隔件移动所述致动环。
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US62/867,815 | 2019-06-27 | ||
US16/908,608 US11497860B2 (en) | 2019-06-27 | 2020-06-22 | Ultra-low waste disposable safety syringe for low dose injections |
US16/908,608 | 2020-06-22 | ||
PCT/US2020/039464 WO2020264057A1 (en) | 2019-06-27 | 2020-06-24 | Ultra-low waste disposable safety syringe for low dose injections |
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JP2022539092A (ja) | 2022-09-07 |
EP3990054A4 (en) | 2023-06-28 |
KR20220031035A (ko) | 2022-03-11 |
US11497860B2 (en) | 2022-11-15 |
CA3144276A1 (en) | 2020-12-30 |
US20200405975A1 (en) | 2020-12-31 |
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WO2020264057A1 (en) | 2020-12-30 |
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