CN116077768A - 低死区针头毂 - Google Patents
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Abstract
本发明涉及一种低死区针头毂(400)和联接到所述针头毂(400)的针头(500),所述针头毂的死区的储存容量小于约0.0190毫升。
Description
技术领域
本说明书总体上涉及用于施用流体的医用针头的领域,更特别是涉及使流体浪费最小化的低死区针头毂(low dead space needle hub)。
背景技术
术语“死区”是指由针头组件与注射筒之间的联接凹进产生的空间。在基于鲁尔的注射筒中,喷嘴内腔加上针头毂的前腔的体积导致死区。传统的皮下注射针头组件由于与喷嘴内腔加上针头毂前腔的体积相关联的死区而浪费一定百分比的药物;当涉及到昂贵药物时,这种浪费是值得关注的。此外,在注射后,大量药物可能会被捕集在针头毂腔的前部中。预计0.10毫升的药物可被捕集在喷嘴内腔加上针头毂腔的前部内;该值在ISO 8537:2016标准中有所规定。对于1.00毫升的注射液,浪费10%的药物。另外,预计在施用0.30毫升的情况下,浪费的药物量可高达33%。注射成本的很大一部分通常是药物费用。减少药物浪费将大大降低医疗成本。
已经尝试通过锥形密封措施来减少死区。参见例如美国专利第5782803、5902271和5902277号。然而,这些类型的装置可能有专用工具要求,这导致更高生产成本。这些装置还可能需要高精度的制造公差。如果不符合这些公差,则不利地,结果是死区的大量增加。
因此,本领域需要一种有效最小化流体浪费的低死区针头毂。
发明内容
本发明涉及一种在注射筒中使用的针头毂,针头毂包括主体,主体具有近端和远端,所述近端适于与注射筒联接,而远端适于与针头联接;其中,具有内通道的针头保持器位于主体内,所述针头保持器延伸超过针头毂的近端,从而防止溶液被捕集在注射筒喷嘴的内腔中;并且所述针头保持器具有至少一个密封环,所述至少一个密封环位于针头保持器的外表面上,所述至少一个密封环防止待分配的溶液被引导向布置在针头保持器与针头毂的主体之间的内腔室。
包括附图以提供对各个方面和实施例的进一步说明和理解,并且附图被并入本说明书且构成本说明书的一部分。
附图说明
本说明书的目标和特征被认为是新的,在所附权利要求书中特别指出。本说明书及其组织和操作模式,连同附加目标和优点,可以通过参考以下说明并结合附图更好地理解,其中:
图1是安装在现有技术的鲁尔锁注射筒上的本发明的低死区针头毂的横截面图。
图2是低死区针头毂的侧视图。
图3是低死区针头毂的前视图。
图4是安装在现有技术的鲁尔滑移(Luer slip)注射筒上的本发明的低死区针头毂的横截面图。
具体实施方式
下面的详细说明仅是例证性的,并不用于限制所公开的实施例或所述实施例的应用和使用。本文中使用的“例证性”或“说明性”一词的意思是“用作示例、实例或说明”。本文中描述为“例证性”或“说明性”的任何实施方式不应被解释为优选于或优于其它实施方式。下文所述的所有实施方式均是为了使本领域技术人员能够做出或使用本公开的实施例而提供的例证性实施方式,并不旨在限制本公开的范围。出于本说明的目的,术语“上”、“下”、“左”、“后”、“右”、“前”、“竖直”、“水平”和它们的派生词将指本发明在图中的定向。此外,无意受以上技术领域、背景技术、发明内容或以下具体实施方式中提出的任何明确或隐含的理论的约束。还应理解,在附图中示出并在以下说明书中描述的具体装置和过程只是所附权利要求书中限定的发明构思的例证性实施例。因此,与本文所述的实施例相关的具体尺寸和其它物理特性不应被视为限制,除非权利要求书另有明确说明。
所述的例证性针头组件形态是在向和/或从受试者施用流体方面讨论的,并且更具体地,就在注射施用期间使药物浪费最小化的针头组件方面进行讨论。本说明书应被认为适用于对受试者注射预防药物、通过皮内、皮下、肌内或静脉内途径施用的药物,以及在与静脉切开术、牙科、矫形、消化、肠道、泌尿、兽医相关的程序中对受试者使用的注射。
在之后的讨论中,术语“靠近”或“近”将指最靠近医疗保健专业人员或医师的结构部分,而术语“远处”或“远”将指离医师最远的部分。本文中使用的术语“受试者”是指接收来自注射筒的注射的患者。根据本说明书,术语“医师”是指施用注射、在注射筒中安装针头组件或从注射筒移除针头组件的个人,并且可以包括支持人员。
出于本发明的目的,应认为术语“近似”的使用提供了某个附加范围。该术语定义如下。该术语提供的附加范围为±10%。举例来说,但不是局限性的,如果说“近似40cm”,则确切范围在36至44cm之间。
图1中例示了本发明的低死区针头组件与第一注射筒100联接,所述第一注射筒100是具有鲁尔锁锥体101、柱塞200和活塞300的注射筒;应提到,该第一注射筒100是现有技术中已知的注射筒,其中,活塞300是锥形的,并且该第一注射筒100具有圆筒凸棱(cylinder cord)103。在另一实施例中,可以使用另一类型的鲁尔锥注射筒,诸如鲁尔滑移锥注射筒。
针头毂400包括主体,所述主体具有近端和远端,所述近端适于通过第一注射筒100的鲁尔接头101与第一注射筒100联接,而所述针头毂400的远端适于与针头500联接。
在针头毂400的主体内设置有具有内通道413的针头保持器403,所述针头保持器403延伸超过针头毂400的近端;
至少一个密封环410,其位于中心针头保持器403的外表面上;以及内腔室411,其设置在针头保持器403和针头毂主体400之间;密封环410的数目可以是一到四个。所述针头保持器403包括圆柱形主体,使得所述圆柱形主体的外表面是光滑且均匀的。
所述至少一个密封环410的功能是防止待从注射筒分配的流体进入到内腔室411中,在内腔室中可以储存多达近似0.0185毫升的流体,从而造成流体的大量浪费。
针头500在针头毂400的远端处通过主组装孔407联接到内通道413。应提到,所述主组装孔407具有内部斜面,使得主组装孔407的初始直径大于最终直径。同样,在内通道413的近端处定位针头限位器401,使得针头500延伸穿过整个内通道413。应提到,内通道413的长度在所述针头保持器403的长度的90-98%之间。因而,与现有技术相比,取决于针头的规格(gauge)和长度,将由于该区域中的死区102加上针头的内部加上在内腔411中产生的死区而导致的残留减少近似80%,使得与浪费多达0.10毫升的常规针头相比,本发明的死区102加上针头的内部储存小于近似0.0190毫升。
在所述内通道413内有至少一个针头联接腔406,所述至少一个针头联接腔406包括至少一个环形凹槽,以填充有胶水并与针头500接触,因而防止所述针头500脱离。
针头毂400具有外表面,在所述外表面上在远端处有至少一对侧部405;优选地,侧部的数目为四个406A、406B、406C、406D,并且所述侧部405布置成在直径方向上彼此直径相对。
针头毂400在其近端处具有至少一个凸缘402,用于套索安装;优选地,凸棱安装凸缘402的数目为两个402A、402B,所述两个凸棱安装凸缘402A、402B在直径方向上彼此相对地布置。
另外,针头毂400具有内表面404,在所述内表面404的端部处有脱模部412,其用于在制造针头毂时对针头毂脱模。
针头组件的组成部分由适合药物注射的材料(诸如,例如聚合材料或金属,诸如不锈钢)制成,这取决于特定医用针头应用和/或医师偏好。半刚性和刚性聚合材料以及弹性材料(诸如医用级模塑聚丙烯)都可考虑用于制造。然而,本领域技术人员应认识到,根据本说明,适合组装和制造的其它材料和制造方法也会是合适的。
本领域技术人员可以修改本文所述的结构。然而,应注意到,本说明书涉及本发明的优选实施例,并且仅是出于说明目的而提供,不应被理解为对本发明的限制。在本发明的精神内所有明显修改,诸如构成本发明的元件的形状、材料和尺寸的改变,都应被视为在所附权利要求书的范围内。
已经以说明性方式描述了本发明,应理解,本文使用的术语旨在对应于本说明书的文字性质,而不是为了提供限制。
显然,根据上述教导,本发明的许多修改和变化是可能的。因此,应理解,在所述的本发明的范围内,可以以不同于具体描述的方式来实践本发明。
Claims (9)
1.一种在注射筒中使用的针头毂(400),所述针头毂包括主体,所述主体具有近端和远端,所述近端适于与注射筒联接,而所述远端适于与针头联接;
其中,具有内通道(413)的针头保持器(403)位于所述主体内,所述针头保持器(403)延伸超过所述针头毂(400)的所述近端,从而防止待分配的溶液被捕集在所述注射筒的喷嘴中;并且
所述针头保持器(403)具有至少一个密封环(410),所述至少一个密封环(410)被设置在所述针头保持器(403)的外表面上,所述至少一个密封环(410)防止待分配的溶液被引导向布置在所述针头保持器(403)与所述针头毂(400)的所述主体之间的内腔室(411)。
2.根据权利要求1所述的针头毂,其中,所述针头保持器(403)包括圆柱形主体,并且其中,所述内通道(413)包括在近端处的水边界(401)。
3.根据权利要求1所述的针头毂,其中,所述针头保持器(403)在其外远端处具有引导锥(408)。
4.根据权利要求1所述的针头毂,其中,所述针头毂在远端处具有主组装孔(407)。
5.根据权利要求4所述的针头毂,其中,所述主组装孔(407)具有内部斜面,使得所述主组装孔(407)的初始直径大于最终直径。
6.根据权利要求5所述的针头毂,其中,在所述主组装孔(407)内定位有至少一个针头联接腔(406)。
7.根据权利要求1所述的针头毂,其中,所述密封环(410)的数目是从一到四。
8.根据权利要求1所述的针头毂,其中,所述针头毂主体(400)具有内表面(404),在所述内表面(404)上具有脱模部(412)。
9.一种注射筒,包括:
注射筒主体,所述注射筒主体具有锥体、柱塞和活塞;
根据权利要求1至8中任一项所述的针头毂,所述针头毂与所述注射筒主体的所述锥体联接。
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