CN101132820B - 预充式针辅助喷射注入器 - Google Patents

预充式针辅助喷射注入器 Download PDF

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CN101132820B
CN101132820B CN2006800066055A CN200680006605A CN101132820B CN 101132820 B CN101132820 B CN 101132820B CN 2006800066055 A CN2006800066055 A CN 2006800066055A CN 200680006605 A CN200680006605 A CN 200680006605A CN 101132820 B CN101132820 B CN 101132820B
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小P·R·莱施
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    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
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    • A—HUMAN NECESSITIES
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    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A—HUMAN NECESSITIES
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    • 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
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
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    • A61M5/46—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 controlling depth of insertion
    • A—HUMAN NECESSITIES
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    • 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
    • A61M5/48—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 varying, regulating, indicating or limiting injection pressure
    • A61M5/484—Regulating injection pressure
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With automatic needle insertion

Abstract

一种喷射注入器，其包括预充式注射器(18)。所述注射器包括包含药物的流体室(22)。所述注射器也具有注射辅助针(24)，柱塞在流体室内可移动。壳体被配置成允许针插入到穿刺深度。能量源被配置成偏压柱塞以在流体室的药物中产生大约80-1000p.s.i.的注射压力，以通过针将药物从流体室喷射注射到注射部位。

Description

预充式针辅助喷射注入器
技术领域
本发明涉及喷射注入器，尤其涉及使用低喷射注射压力的针辅助喷射注入器。
背景技术
在美国专利Nos.5,599,302；5,062,830；和4,790,824中描述了无针注射器的例子。这些传统注射器将药物作为在充足压力下输送的细、高速喷射施予以使喷射流体能够穿过皮肤。在注射器中包含药物的隔室内部，用于输送药物的压力典型地大于大约4000p.s.i。除了允许无针注射之外，由这样的压力得到的益处包括注射的速度、被注射药物分散到组织中和注射输送不受药物被输送处组织的阻力影响。
类似于美国专利Nos.4,553,962和4,378,015和PCT公开文本WO95/29720和WO97/14455中公开的自注射器或自动注射器被构造成以一定的速率和以类似于手动皮下注射器的方式注射药物。自注射器或自动注射器具有针，在启动的时候所述针延伸以穿刺使用者的皮肤，从而通过药物容器和相关针的移动输送药物。因而在自注射器和自动注射器中提供力来输送药物的机构也用于延伸针和药物容器，以导致针通过使用者的皮肤插入。例如由Owen Mumford制造的自动注射器因而使用很低的压力来注射药物，药物通过针以较慢的流量被注射。施加在该类型装置的含药隔室中的压力很低，最大达到大约60p.s.i.并且耗时大约6秒注射1mL。这些装置并不使用喷射注射来输送药物，因此药物在针尖端以剂团被输送，所述针尖端典型地穿刺患者典型地至少大约12mm。当这些低压力和注射速率与较短的针，尤其与穿刺患者大约5mm或更小的那些针一起使用时，在针周围或通过在组织中形成的孔倒漏被注射药物的发生率高。
预充式注射器，例如目前由Becton和Dickinson作为BD HypakTM销售的那些注射器旨在用于慢速、手动或自动注射器注射。尽管预充式注射器容易获得，但是所利用的制造技术导致尺寸公差，传统上认为所述尺寸公差对于喷射注入器来说太宽松，原因是注射器将需要耐受足以喷射注射药物的高压的很苛刻应用。另外，预充式注射器包括被成形为保持针的部分和由手抓握进行注射的凸缘，所述部分和凸缘产生了容易破裂的特征。存在于注射器主体中的残余应力也增加了它们的易碎性，这是典型地认为它们用在喷射注入器中太易碎的原因之一。因而，喷射注入器典型地使用更坚固的针筒，并且不带有供手持使用的部件，其在制造时具有比典型预充式注射器更紧密的公差。
需要这样一种注射器，该注射器可以可靠地将药物快速且基本上不考虑组织阻力地注射到预期部位，而没有从患者的皮肤倒漏出药物的重大风险，并且优选地能够使用标准预充式注射器。
发明内容
本发明涉及一种喷射注入器。优选实施例利用一种预充式注射器，在组装装置之前所述预充式注射器优选地预装有药物。所述注射器具有容器部分，所述容器部分限定包含药物的流体室。注射辅助针布置在所述室的远端并且具有被配置成用于穿刺插入位置的注射尖端。所述针限定与所述室流体连通的流体路径以用于将流体从所述室注射到注射部位。所述注射器也具有在所述流体室内可移动的柱塞。
在该实施例中，壳体容纳预充式注射器并且被配置成允许在注射位置的针插入到插入点，所述插入点在插入位置的表面之下一个穿刺深度处。注射器支座将预充式注射器支撑地固定到所述壳体，并且能量源被配置成用一定的力偏压所述柱塞，所述力被选择成在所述流体室的药物中产生大约80-1000p.s.i.的注射压力。该压力通过针将药物从所述流体室注射到远离所述注射尖端的注射部位。所述穿刺深度和注射压力优选地足以允许比自动注射器更好地分配药物并且基本上防止被注射药物的回流。在优选实施例中，注射速率基本上不受组织阻力影响。
优选地包括弹簧的所述能量源优选地被配置成产生所述注射压力，在注射药物期间，所述注射压力保持在大约500p.s.i.以下和大约90p.s.i.以上。更优选地，在注射药物期间，所述注射压力保持在至少大约100p.s.i.和小于大约350p.s.i.。
所述壳体优选地被配置成允许针的一部分插入到插入位置的表面之下大约0.5mm-5mm的穿刺深度。在一个实施例中，所述穿刺深度为大约1mm-4mm，更优选地小于大约3mm。在一些实施例中，所述注射压力和穿刺深度优选地足以使得注射部位在皮下，尽管在其他实施例中可以实现其他类型的注射。例如对于肌内注射，针的露出部分例如可以为大约10mm-15mm，优选实施例为大约13mm。
所述注射器具有预充式注射器的远侧部分和与所述远侧部分相对的近侧部分，注射辅助针位于所述远侧部分中。所述注射器支座可以被配置成在喷射注射药物期间轴向地支撑预充式注射器的近侧部分，使得预充式注射器的远侧部分基本上沿轴向方向未被支撑。
预充式注射器优选地由吹制玻璃制造，所述吹制玻璃可以形成于注射辅助针上，但是通常形成并附着到所述针。另外，所述流体室的优选体积为大约0.02mL-4mL药物。
所述壳体的优选实施例包括在保护位置和注射位置之间可移动的可缩回护罩。在保护位置，所述针布置在所述护罩中，但是在注射位置，所述针的尖端露出以用于插入到插入点。触发机构可以与所述能量源可操作地相联以用于启动能量源，从而喷射注射药物。所述触发机构优选地被配置成在所述可缩回护罩从保护位置缩回之后，最优选地一旦它从注射位置缩回，启动所述能量源。
可以提供与所述注射器支座和预充式注射器相联的注射器衬垫以补偿预充式注射器的形状不规则性和/或在装置被击发期间为注射器缓冲和提供震动吸收。在一个实施例中，由所述弹簧偏压在所述柱塞上以产生注射压力的撞杆带有钟形部分，所述能量源的所述弹簧就座在所述钟形部分上。所述钟形部分限定中空内部，所述中空内部被配置成当装置被击发时接收预充式注射器，使得所述弹簧围绕预充式注射器。
本发明因而提供一种喷射注射装置，该喷射注射装置提供更好的药物分配并且可以可靠地使用低压非喷射注入器的更短针。而且，本发明的喷射注入器可以通过使用传统上用于慢注射的预充式注射器而从简化的制造受益。
附图说明
图1是根据本发明构造的喷射注入器的优选实施例的侧视图，其显示了在注射之前的注射器；
图2是沿着平面II-II获得的其横截面图；
图3是用于优选实施例中的预充式注射器的透视图；
图4是优选实施例的注射器衬垫的透视图；
图5是图1的实施例的横截面图，其显示了在喷射注射开始时包含在其中的实施例的注射器；
图6是在喷射注射期间在优选实施例中存在于包含药物的污染室中的典型压力；
图7是被配置成使用窄径预充式注射器的注射器的另一实施例的侧视图；
图8是沿着VIII-VIII得到的横截面图；和
图9是使用肌内喷射注射针的注射器的另一实施例的横截面图。
具体实施方式
参考图1和2，注射器10的优选实施例具有被配置成允许用户操作注射器10的壳体12。壳体12包括基本上容纳图2中所示的大多数部件的外壳元件14。注射器支座元件16容纳在壳体12内并且与壳体12安装在一起。注射器支座元件16被配置成保持和定位在图3中显示的预充式注射器18。在优选实施例中，注射器支座元件16例如通过卡扣、粘合剂、熔接或另一种已知的连接物基本上固定到壳体12。预充式注射器18具有在其内部限定流体室22的容器部分20，所述流体室预充有待注射的药物。注射辅助针24在预充式注射器18的远端。针24具有注射尖端26，所述注射尖端如本领域中已知的方式构造以穿刺患者的组织，优选皮肤。如本领域已知的，针孔径延伸通过针24。所述孔径与流体室22中的药物流体连通并且在针尖端26敞开以注射药物。
将药物密封在流体室22中的柱塞28在流体室22的近侧且与针24相对。注射器壁30优选地包括管状部分，所述管状部分优选地在近端闭合并且在远端敞开，从而限定流体室22。柱塞28可滑动地容纳在管状部分中。预充式注射器20被配置成使得当柱塞28沿远侧方向移位时，流体室22的体积减小，从而从那里通过针24的孔径挤出药物。
针接口部分32在流体室22的远端，针安装到所述针接口部分。注射器凸缘34优选地从注射器壁30的近端径向地延伸。
在优选实施例中，注射器18具有注射器主体36，所述注射器主体包括整体结构的凸缘34、壁30和接头部分32。用于注射器主体36的优选材料是玻璃，但是其他材料可以用在其他实施例中。合适的预充式注射器是BD HypakTM，其可获得各种尺寸和体积并且在销售时预装有药物。注射器主体的玻璃附着到针。典型药物和药物种类包括肾上腺素、阿托品、舒马曲坦(sumatriptan)、抗生素、抗抑郁药和抗凝血药。注射器被组装时，使用预充式注射器促进了药物的操作，而对药物在预充式注射器中如何保持和动作的认识有很多。
在图4中详细显示的注射器衬垫38优选地由弹性体材料或其他弹性材料制造。注射器衬垫38的凸缘40径向地延伸并且被布置成和用作在注射器支座元件16的远侧和注射器凸缘34之间的交界面。升高部分，例如隆块42，从衬垫凸缘40朝近侧延伸并且被配置和尺寸形成为邻接注射器凸缘34。
由吹制玻璃法制造的预充式注射器可以具有显著的尺寸公差和粗糙度，特别是在玻璃主体36中。衬垫38可以用于调节形状不规则性和将预充式注射器18正确地安置和定位在注射器支座16内。典型地，1mL预充式注射器上的玻璃吹制注射器凸缘的轴向厚度在大约±0.5mm内。对于BD HypakTM 1mL标准预充式注射器，注射器凸缘34的厚度为2mm+0.5mm或-0.4mm，并且在1mL长结构BDHypakTM注射器中，凸缘轴向厚度为大约1.65mm±0.25mm。出现在典型玻璃预充式注射器中的其他尺寸变化在管状壁30的内径和外径内。这些变化可以由注射器衬垫38的弹性套筒部分44调节，所述弹性套筒部分围绕注射器支座16的内部轴向地延伸。注射器衬垫38优选地容纳在注射器支座元件的内部并且容纳注射器主体36，优选紧密地适配在其中。
套筒部分44优选地具有径向向内延伸的突出部46，所述突出部具有选择的表面面积和结构以允许在组装期间预充式注射器18插入到其中，但是提供足够的摩擦以将注射器18保持就位，并且在注射器击发期间提供缓冲和震动吸收。向外突出部48也设在套筒部分44上，其可以容纳在注射器支座16的相应凹窝中以防止其间的轴向旋转。如果套筒部分44的壁厚增加是非理想的，凹陷区域50可以设在注射器衬垫38的内部和外部上与套筒部分44的相对径向侧面上的相应突出部48相对。在备选实施例中，注射器衬垫38的凸缘40和套筒44之一或两者基本上是平滑的，基本上没有任何突出部。优选地，注射器衬垫38的材料和结构也足以完全支持预充式注射器20耐受沿远侧方向轴向地施加到柱塞28上的击发力。因而，预充式注射器20的整个支座可以设在注射器凸缘34上，而注射器18的远端自身可以沿轴向方向基本上未被支撑。这可以帮助抵抗由流体室22内的高压产生的预充式注射器20的玻璃主体36上的震动。
为了径向定位预充式注射器18的远端，注射器支座16优选地具有缩窄的孔径部分51，所述缩窄的孔径部分优选被构造成邻接注射器壁30的外侧。当针插入到患者的皮肤中时，这是特别有利的。缩窄的孔径部分可以由弹性材料例如弹性体制造，或者它可以制成与注射器支座16的剩余部分形成整体，优选由塑料材料制成。
触发机构52还优选容纳在壳体12内。触发机构52包括内壳体54，所述内壳体例如可以通过卡扣、粘合剂、熔接或其他已知的连接物连接到外壳体14。触发突出部56从内壳体54的近端向内延伸并且被弹性地向外偏压。触发突出部56被容纳在撞杆60的凹窝58中与其形成阻挡关系，以防止在设备击发之前撞杆60朝远侧移动。撞杆60由能量源朝着注射器10的远端推动，所述能量源优选地是压缩弹簧52，尽管可以备选地使用其他合适的能量源，例如弹性体或压缩气体弹簧。压缩弹簧的优选类型是卷簧。
触发机构52的触发元件，例如闭锁壳体64，设在内壳体的外部以将触发突出部56以阻挡关系保持在凹窝58中，从而防止过早击发注射器10。闭锁壳体64优选地沿轴向相对于内壳体54在外壳体14内部可滑动，并且闭锁壳体64优选围绕内壳体54。
壳体12具有相对于外壳体14可移动的针护罩66。针护罩66在图1和2中被显示成处于保护位置，在保护位置处针24布置在护罩66内。针护罩66沿近侧方向可缩回到注射位置，优选进入外壳体14，在注射位置处针尖端26和针24的端部如图5中所示被露出以插入到患者中。在优选实施例中，在注射位置基本上防止护罩的近侧移动。
针护罩66与闭锁壳体64相连，使得当护罩66朝远侧移位时，它也沿远侧方向滑动闭锁壳体64，以从凹窝58释放触发突出部56。优选地，闭锁壳体64具有闭锁部分68，所述闭锁部分以这样一种关系邻接内壳体54，即在设备10击发之前偏压和保持定位成与撞杆60成阻挡关系的触发突出部58。当由于护罩66缩回到注射位置而使闭锁朝近侧滑动时，闭锁部分68滑动超出内壳体54的一部分，所述部分是接触并将触发突出部56弯曲到撞杆60的凹窝58中的部分，从而允许触发突出部56从凹窝58径向向外移动，所以离开阻挡关系。当该情况发生时，弹簧62将撞杆60偏压在柱塞28上以击发喷射注入器。闭锁壳体64优选地限定邻近闭锁部分68的触发开口70，所述触发开口被构造成容纳内壳体54的一部分，例如从触发突出部56径向向外布置的表面。
护罩66优选地由压缩卷簧72朝着保护位置弹性地向远端偏压。而且，针护罩66具有轴向开口74以允许针24穿过其中，并且其可以根据预期注射器的类型确定尺寸。本实施例的构造允许使用者将注射器10的远端推靠在患者的皮肤上，从而以基本上与推动注射器相同的速度将针24推入在插入位置的皮肤中。一旦针24以穿刺深度完全插入到插入点，触发机构56向注射部位击发喷射注射。
优选地，预充式注射器18及其针24并不自动向前移动到患者的皮肤中，例如通过在注射击发期间击发能量源。使用者优选地轻轻向前推动整个装置以插入针，优选地在所述过程中缩回护罩靠在皮肤上。预充式注射器18优选地在壳体12内保持基本固定，其并且优选地基本固定到那里。这样，本发明在注射期间提供了注射器的更温和处理，这样允许使用足够强力的弹簧62或其他能量源产生喷射注射，而没有损坏预充式注射器的相对易碎和复杂的形状的风险，同时允许例如高粘度溶液的注射，在该情况下在将注射器向前移动到壳体和患者中的现有技术的注射器中，例如在凸缘损坏注射器的风险高。残余应力也常常存在于预充式注射器的玻璃主体中，该结构减小了使用期间施加在其上的附加应力，从而进一步保护注射器。而且，由于使用这样结构轻轻插入针是可能的，因此也使得预充式注射器中的未对准在操作上显得不太重要。
优选地，护罩66的注射位置使得针24的末端的预定长度从护罩66露出。在一些实施例中，例如在开口74具有足够大的直径的情况下，当装置10被压靠在那里时，可能允许患者的皮肤伸入开口74中，并且没有突出到护罩66的远端之外的针可以被使用同时仍然穿刺到皮肤的某个深度。在大多数实施例中，针尖端26延伸超出护罩66的远端的距离76将相当接近针的插入深度。
在优选实施例中，例如对于皮下注射，护罩66被配置成允许针插入到皮肤中的穿刺深度，该穿刺深度在皮肤表面下面最高达到大约5mm。更优选地，穿刺深度小于大约4mm，并且在一个实施例中小于大约3mm。优选地，插入深度为至少大约0.5mm并且更优选地至少大约1mm。在另一实施例中，针延伸超出护罩66或接触皮肤的护罩66的远侧表面的距离76最高达到大约5mm，更优选地最高达到大约4mm，并且在一个实施例中最高达到大约3mm。优选地，延伸距离76为至少大约0.5mm，更优选地至少大约1mm，并且最优选地至少大约2mm。在优选实施例中，尖端26延伸超出在注射位置接触皮肤的护罩66的部分的距离76为大约2.5mm。
在另一实施例中，例如对于肌内注射，注射器被配置成允许针插入到患者中到达皮肤中的穿刺深度，或者备选地超出护罩的远侧表面最高达到大约15mm的距离。在一个实施例中，该距离为大约10mm-14mm。例如在肾上腺素的喷射注射的实施例中，优选穿刺深度或超出护罩的距离为大约12mm-13.5mm，并且最优选为大约12.7mm。用该长度的针进行喷射注射与非喷射注射相比改善了药物在患者组织中的分配。其他露出的针长度可以被选择用于喷射注射到皮肤下的不同深度，优选总穿刺长度在大约0.5mm至大约20mm之间。在这些实施例中，针护罩优选地被配置成从优选覆盖整个针的保护位置缩回到注射位置，在所述注射位置中针的末端的预期长度被露出。
弹簧62和预充式注射器18被配置成喷射注射药物。因而，弹簧62在柱塞28上施加力，该力足以将流体室22内的压力升高到足够高的水平以从作为喷嘴的针24射出药物。喷射注射应当被理解成用足够的速度和力将药物驱动到远离针尖端26的位置的注射。在手动和自动注射器类型的注射中，其中注射压力很低，药物在患者内部离开针尖端，并且典型地以剂团局部沉积在针周围。在另一方面，使用本发明的喷射注射装置10，药物例如通常由高压喷嘴径向地、远侧地或沿其他方向被喷射注射，这有利地改善了注射后药物的分配并且阻止大剂团形成，所述大剂团形成可以有害地使药物在针周围或通过取出针后它所留下的孔倒漏到患者之外。
参考图6中所示的图表，标号78代表装置10被击发时的时点，标号80代表完成药物注射，预选地当柱塞28碰撞容器部分20的前壁时的时点。标号82代表注射期间的初始和峰值压力，标号84代表注射期间的最终和低压力。由于优选实施例的弹簧62具有线性弹簧常数，并且注射辅助针用于在开始注射之前穿刺皮肤，因此从注射78开始直到注射结束，压力基本线性地下降。在注射的结束80的最终压力84足够高使得即使在撞杆60的击发冲程的结束时，药物仍然被喷射注射，并且很少量或没有药物以剂团沉积在针尖端26周围。
注射期间的峰值压力优选地小于大约1,000p.s.i.，更优选地小于500p.s.i.，并且最优选地小于大约350p.s.i.。在注射的结束80时，施加到流体室22中的药物的压力84优选地为至少大约80p.s.i.，更优选地为至少大约90p.s.i.，并且最优选地为至少大约100p.s.i.。在本发明的一个实施例中，初始压力82为大约330p.s.i.，最终压力为大约180p.s.i.，而在另一实施例中初始压力82为大约300p.s.i.，在注射的结束80时下降到大约110p.s.i。用于这些实施例中的针在26至28口径(gage)之间，并且最优选地为大约27口径，但是在其他部件被配合构造成产生预期注射的情况下，可以备选地使用其他针口径。优选地，注射器10的部件被构造成将药物喷射注射到皮下注射部位。
包含在和从流体室22注射的药物量优选地为大约0.02mL-4mL，更优选地小于大约3mL，并且在优选的实施例中为大约1mL。也可以取决于所需的特定药物和剂量选择更大体积。优选地，预充式注射器被组装到已经包含预期药物量的喷射注入器10的剩余部分中。在优选实施例中，预充式注射器包含大约1mL的药物。
优选的注射速率为小于大约0.75mL/sec，更优选小于大约0.6mL/sec，并且优选地至少大约0.2mL/sec，更优选地至少大约0.3mL/sec，最优选地至少大约0.4mL/sec。优选地，全部药物量的注射在小于大约4秒内完成，更优选地小于大约3秒，并且最优选地小于大约2.5秒。优选地，药物注射耗时为至少大约1秒，更优选地至少1.5秒，并且最优选地至少大约1.75秒。优选实施例以大约0.5mL/sec的速度注射药物，从而在大约2秒内完成1mL的注射。
美国专利No.6,391,003公开了可以使用26和27口径针施加到玻璃针筒中的药物的压力的几个实验结果。下表示出了带有可以用于玻璃预充式注射器的不同峰值压力的注射：
注射1cc的压力和时间(妙)
压力       26口径针  27口径针
150p.s.i.  2.1       4.2
200p.s.i.  1.9       3.9
240p.s.i.  1.7       3.3
375p.s.i.  1.4       3.1
可以预见更高压力和流率将用于更短的针穿刺到患者皮肤中以实现喷射注射到特定预期深度而基本上没有药物倒漏。
业已发现使用本装置的喷射注射，短针可以用于将药物注射到皮肤的不同部分，优选皮下，而且基本上没有任何倒漏。使用从针护罩66延伸大约2.5mm的针，即27口径针24，和峰值为大约300p.s.i.并且在大约100p.s.i.结束的流体室22中的压力，其导致大约0.5mL/sec的速率，可以发现在接近100％的测试注射中1mL的药物成功地被注射而没有倒漏。因而，本发明的针辅助喷射注入器允许可靠地使用很短的针喷射注射药物，而不考虑患者的皮肤厚度或患者的年龄、体重或用短针时使非喷射注射复杂的其他典型因素。
图7和8显示了本发明的另一实施例，该实施例使用具有长的、但直径比图2的实施例更小的结构的预充式注射器。尽管在图2的实施例中，击发弹簧62在击发冲程期间延伸到预充式注射器18的孔径中，注射器86的较窄预充式注射器88不提供同样多的空间来容纳弹簧。因此，注射器86的撞杆90包括限定中空内部94的钟形部分92，所述中空部分被构造成当注射器86被击发后容纳预充式注射器88和注射器支座96的近端。类似地，钟形接收空间98被限定在预充式注射器88和注射器支座96的外部周围，以在击发期间接收钟形部分92。钟形部分92包括弹簧座100，该弹簧座径向向外延伸并且被构造和布置成使压缩弹簧102就座。当触发机构56被启动和装置86被击发时，弹簧102作用在座100上以将撞杆90驱动抵靠到柱塞104，从而从流体室106喷射注射药物。结果，在击发后，弹簧102径向地围绕预充式注射器88。外壳部分108比注射器10的外壳部分14更宽以容纳钟形部分92和直径更大的弹簧102。
1mL容量的一个可用的长结构注射器具有直径为8.15mm的圆柱形注射器主体部分，其可以典型地用在图7和8的注射器中，而相同容量的一个可用的较短结构注射器具有直径为10.85mm的圆柱形注射器主体部分，其可以用在图1和2的注射器中。尽管带有钟形部分的实施例可以用于较宽/较短的注射器，它优选地带有这样的预充式注射器，即所述预充式注射器的外径圆柱形壁小于大约10mm，更优选地小于大约9mm。
注射器86还包括帽110，该帽配合在针护罩66周围并且与外壳108相连，以防止针护罩66缩回和装置86触发。另外，帽110封闭针尖端26并且可以在使用装置86之前被去除。帽110优选地被构造成与其成卡扣配合关系地适配在针护罩66上，例如通过包括与针护罩66的直径扩大部分114相连的直径较窄部分112。
另外，注射器86利用注射器垫帽116，该注射器垫帽围绕注射器凸缘34的外部从注射器衬垫118延伸，以帮助捕捉和保持预充式注射器88。垫帽122连接到衬垫118并且优选地与其形成整体构造。当针24正被插入患者时，垫帽122邻接注射器主体120的远端，以径向定位和保持主体120的近端。类似于图2的实施例，注射器支座96例如通过安装部分124在基本固定位置中与壳体相联，所述安装部分捕捉注射器支座的突出部126。
参考图9，注射器128具有针护罩130，该针护罩被构造成在触发机构52击发喷射注射之前比图1和2或5的注射器进一步缩回到注射器壳体中。该图中的注射器被显示成处于一个位置，在该位置中触发机构52正被释放并且将要击发注射。针延伸超出护罩130或护罩130的接触皮肤的远侧表面的距离76优选地为大约12.5-13mm。在优选实施例中，护罩优选地被构造成在装置被击发和从患者被去除之后例如在弹簧72的偏压下再延伸到保护位置，并且由本领域中已知的锁定元件132锁定在该位置以防止再使用注射器。
在其他实施例中，护罩长度、护罩注射位置相对于针尖端的位置(包括保护和注射位置之间的护罩行程)和从注射器主体开始的针的长度可以被选择成在击发装置之前允许或更浅或更深的针插入，从而分别提供或更大或更小的距离76。优选地，防止护罩比基本上在击发位置进一步向后滑动，从而更好地控制在患者中的插入深度。
美国专利No.6,391,003的全部公开内容被结合于此以作参考。
尽管在此公开了本发明的示例性实施例，应当理解本领域的技术人员可以设计许多修改和其他实施例。例如，各种实施例的部件可以用于其他实施例中，例如可以应用于图1实施例的图7和8的针和护罩帽。所以，应当理解所附权利要求旨在涵盖属于本发明的精神和范围内的所有这样的修改和实施例。

Claims (14)

1.一种喷射注入器，其包括：
预充式注射器，其包括：
容器部分，其限定包含药物的流体室；
注射辅助针，其布置在所述流体室的远端，并且具有用于穿刺插入位置的注射尖端，以及限定与所述流体室流体连通的流体路径以用于将流体从所述流体室注射到注射部位；
柱塞，其在所述流体室内可移动；以及
壳体，其容纳预充式注射器并且允许针在注射位置插入到插入点，所述插入点在插入位置的表面之下的一个穿刺深度处；
注射器支座，其将预充式注射器支撑地安装到所述壳体；以及
能量源，其以一定的力偏压所述柱塞，所述力被选择成在注射药物期间在所述流体室的药物中产生保持在80p.s.i.-1000p.s.i.的注射压力，以通过针将药物从所述流体室喷射注射到注射部位。
2.根据权利要求1所述的喷射注入器，其中所述能量源和预充式注射器在注射药物期间使得所述注射压力保持为小于500p.s.i.且大于90p.s.i.。
3.根据权利要求1所述的喷射注入器，其中所述能量源在注射药物期间产生保持在至少100p.s.i.的所述注射压力。
4.根据权利要求3所述的喷射注入器，其中所述能量源和预充式注射器在注射药物期间使得所述注射压力保持在最高达到350p.s.i.。
5.根据权利要求1所述的喷射注入器，其中所述壳体允许针插入到穿刺深度，该穿刺深度在插入位置的表面之下0.5mm-5mm。
6.根据权利要求1所述的喷射注入器，其中所述壳体允许针插入到穿刺深度，该穿刺深度在插入位置的表面之下11mm-13mm。
7.根据权利要求1所述的喷射注入器，其中所述能量源包括弹簧，并且所述喷射注入器还包括由所述弹簧偏压在所述柱塞上以产生注射压力的撞杆，其中所述撞杆包括钟形部分，所述弹簧就座在所述钟形部分上，并且所述钟形部分限定中空内部，所述中空内部用于当装置被击发时接收预充式注射器，使得所述弹簧围绕所述预充式注射器。
8.根据权利要求1所述的喷射注入器，其中：
所述预充式注射器具有远侧部分和与所述远侧部分相对的近侧部分，所述注射辅助针位于所述远侧部分中；以及
在喷射注射药物期间，所述注射器支座轴向地支撑预充式注射器的近侧部分，从而预充式注射器的远侧部分沿轴向方向未被支撑。
9.根据权利要求8所述的喷射注入器，其中：
所述预充式注射器具有注射器主体，该注射器主体包括为整体结构的凸缘、壁和接头部分；
所述预充式注射器的注射器主体由玻璃制成；
所述注射辅助针附着到所述玻璃的注射器主体；
所述注射辅助针具有针孔，所述针孔延伸通过所述注射辅助针，并且与所述流体室中的药物流体连通；
所述流体室包含0.02mL-4mL的药物。
10.根据权利要求1所述的喷射注入器，进一步包括触发机构，该触发机构与所述能量源可操作地相联，用于启动能量源以喷射注射药物，其中：
所述壳体包括在以下位置之间可移动的可缩回护罩：
保护位置，其中针位于护罩中；
注射位置，其中针的尖端露出以用于插入到插入点；以及
所述可缩回护罩可操作地与所述触发机构相联，以当所述护罩缩回到注射位置时使触发机构启动所述能量源。
11.根据权利要求1所述的喷射注入器，其中所述穿刺深度和注射压力足以防止被注射药物的回流。
12.根据权利要求1所述的喷射注入器，进一步包括注射器衬垫，该注射器衬垫与所述注射器支座和预充式注射器相联，以补偿预充式注射器的形状不规则性。
13.根据权利要求1所述的喷射注入器，其中所述注射压力足以通过所述针将所述药物从所述流体室喷射注射到远离所述注射尖端的注射部位。
14.根据权利要求1所述的喷射注入器，其中所述注射压力和穿刺深度足以使得注射部位在皮下。
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