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CN107029317B - 药物注射器 - Google Patents

药物注射器 Download PDF

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CN107029317B
CN107029317B CN201510464642.1A CN201510464642A CN107029317B CN 107029317 B CN107029317 B CN 107029317B CN 201510464642 A CN201510464642 A CN 201510464642A CN 107029317 B CN107029317 B CN 107029317B
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spring
piston
injector
medication
flow
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CN107029317A (zh
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贺小军
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Chongqing Beijia Medical Equipment Co., Ltd
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Chongqing Beijia Medical Equipment Co ltd
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Priority to CN201510464642.1A priority Critical patent/CN107029317B/zh
Priority to PCT/CN2016/092121 priority patent/WO2017020773A1/zh
Priority to KR1020187005999A priority patent/KR20180048660A/ko
Priority to US15/749,200 priority patent/US20180228965A1/en
Priority to EP16832261.8A priority patent/EP3332820A4/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/1454Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons spring-actuated, e.g. by a clockwork
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/148Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
    • A61M5/152Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags pressurised by contraction of elastic reservoirs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804Flow controllers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M2005/14208Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type

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  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
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  • Life Sciences & Earth Sciences (AREA)
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  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

本申请公开了一种药物注射器。该药物注射器包括具有容积空间的药物容器(10)以及在所述容积空间中设置有活塞(20)。在所述容积空间位于所述活塞的一侧可形成为用于容纳药物的药物腔(30),在所述活塞(20)的另一侧上设置有恒力提供装置(40),用于向所述活塞(20)提供恒定的推力,以推动所述活塞(20)沿着容积空间的延伸方向移动,从而通过改变药物腔(30)的容积而将所述药物腔(30)中的药物推出。

Description

药物注射器
技术领域
本申请涉及一种药物注射器,尤其涉及一种具有横流药液推动装置的药物注射器。
背景技术
在现有的治疗过程中,很多药物被制成缓释胶囊以达到延迟药效的目的。这种方法简单但是药量不能被准确恒定释放,因此对需要准确释放药量的治疗并不合适。有时候为了达到持续恒定注射药液的目的,病人必须住在医院里,通过复杂的机器设备进行比较准确的注射,比如点滴或者电子泵。这样的方法不但大量占用医疗资源,而且将病人束缚在病床上,使得病人无法正常的工作和生活。
对于需要长期做恒定量药物注射的患者,必须有一个可以使其独立操作的方法,从而脱离医院和医生的监护,使治疗不致影响其正常的工作和生活。
目前已有的恒流药物泵,比如靠电子编程的胰岛素泵,使用复杂,价格昂贵,并且由于体积大而造成患者生活的不便。
发明内容
本申请的目的在于提供一种能够至少克服现有技术中的一些缺陷的药物注射器。
本申请的一个方面提供了一种药物注射器。该药物注射器包括具有容积空间的药物容器以及在所述容积空间中设置有活塞。在所述容积空间位于所述活塞的一侧为用于容纳药物的药物腔,在所述活塞的另一侧上设置有恒力提供装置,用于向所述活塞提供恒定的推力,以推动所述活塞沿着容积空间的延伸方向移动,从而将所述药物腔中的药物推出。
在一个实施方式中,可利用大压缩比弹簧,短距离行程的恒力弹簧作为所述恒力提供装置。在另一个实施方式中所述恒力提供装置可包括:套筒,以及设置在所述套筒上相互邻接的第一弹簧(小)和第二弹簧(大)。所述第一弹簧(小)具有比第二弹簧(大)小的剖面,从而使得在所述第一弹簧(小)和所述第二弹簧(大)被压缩时,受到压缩的第一弹簧收缩到受到压缩的第二弹簧(大)内。
根据本申请一个实施方式的药物注射器还可包括限流器。该限流器设置在所述药物腔的药液流体接收方向,用于限制从所述药物腔推送出的药液的流量。
在一个实施方式中,所述限流器具有细管的构造,从而利用毛细管的限流作用,使得药液的流量达到精确的恒流效果。在另一个实施方式中,所述限流器包括用于接收从所述药物腔推送出的药液的细管;以及设置于所述细管内的柱体。所述柱体与所述细管的内管壁形成允许所述接收的药液通过的间隙。所述柱体位于所述细管内的长度预先设定,从而调节通过所述间隙的药液流量。
在一个实施方式中,在所述限流器的流体流出方向上具有针软管,用于通过连接到该软管上的针将药液输送到人体。
根据本申请的另一个方面还提供了一种药物注射器系统。该系统可包括如上所述的药物注射器;以及用于支撑所述药物注射器的基底。基底具有预设的开口使得所述药物注射器的针软管从中穿过,当所述药物注射器系统通过粘结部件粘贴在患者皮肤上,药物由所述针软管进入病人体内。
本申请进一步简化机械式恒流泵/药物注射器,以最简单的机械方式实现对药物的持久恒定注射。可通过例如胶布粘贴的方式将药物注射器附着在患者的皮肤上,药物由留置软管进入病人体内,从而使患者可以自由的在其正常生活和工作状态中得到可靠和有效的治疗。
上述技术方案和现有的弹簧驱动恒流泵类似,但在并不需要液压部分。在液压部分被取消之后,为了弥补增大的弹簧工作行程给精确度造成的问题,利用套筒复合弹簧来大大增加弹簧的自由长度,以此减小恒力弹簧在工作行程两端之间的误差。
附图简要说明
图1所示为根据本申请一个实施方式的药物注射器100的示意图。
图2所示为根据本申请一个实施方式的恒力提供装置40的组成示意图。
图3所示为根据本申请一个实施方式的管式限流器的平面示意图。
图4所示为根据本申请一个实施方式的药物注射器系统的示意图。
具体实施方式
下面参照附图对本申请的实施方式进一步描述。在附图中,相同的附图标号使用相同的附图标记,并且为了清楚起见,在附图中省略了一些元器件。
如图1所示为根据本申请一个实施方式的药物注射器100的示意图。如图1所示,药物注射器100包括药物容器10。药物容器10可具有例如管状的容积空间。在该容积空间中设置有可沿其延伸方向移动的活塞20,活塞20沿着空间的移动使得在容积空间的一侧形成体积变化的、用于容纳药物的药物腔30。在容积空间的另一侧,恒力提供装置40直接固定在药物活塞上。恒力提供装置40能够向药物活塞施加恒定的力,推动活塞20沿着容积空间的延伸方向移动,从而通过该变药物腔30的容积,而将药物腔30中的药物推出。
在该实施方式中,和现有的技术相比,由于液压部分被去掉,药物腔的容积比(液压部分)的液压腔的容积增加了数倍之多。如果直径变比是四比一的话,现在直接推动药物活塞等于是一比一,体积增加四倍。如果药物腔的直径不能增加很多(受装置厚度限制),那么弹簧的作动距离就增加了几倍。在弹簧自由长度不能增加的情况下,弹簧从开始推进到结束推进的过程中,保持恒力就很困难。如果此时还认为弹簧是恒力弹簧的话,那么这个恒力在开始和结尾的误差就会很大。所以,必须重新设计恒力提供装置来保证装置有足够的精确度。
在本申请的一个实施方式中,恒力提供装置可包括大压缩比、短距离行程的恒力弹簧。图2所示为根据本申请一个实施方式的恒力提供装置40的组成示意图。如图2所示,恒力提供装置40包括套筒401,分别设置在套筒401上的第一弹簧402(小)和第二弹簧403(大)。套筒可用金属或者ABS等塑料形成。套筒401的一端具有用于限制第二弹簧403的突起4031和用于限制第一弹簧的凸起4032。第一弹簧402和第二弹簧403在套筒上相互邻接,并且第一弹簧402(小)具有比第二弹簧403(大)小的剖面,从而使得在两个弹簧被压缩时,受到压缩的第一弹簧402(小)收缩到受到压缩的第二弹簧403(大)内。可通过设置在套筒上的推杆(未示出)来压缩两个弹簧。两个弹簧可用一般弹簧钢或者不锈钢形成,并且它们的刚性系数完全相同。图2还单独示出了套筒401的配置结构和第一弹簧402(小)和第二弹簧403(大)逐步压缩的状态示意图。
由于尺寸的限制,有时候装置内留给弹簧的空间是有限的。而恒力弹簧的设计需要尽可能的增加弹簧的自由长度,因此弹簧的压缩长度也随之增加。采用如上图所示的弹簧套弹簧的设计:一个直径比较大的弹簧在外,一个直径略小的弹簧在内,两个弹簧用一个连接套桶首尾相联,在给定尺寸的情况下,大大增加弹簧的长度。
假设直径大的弹簧其自由长度为L1压紧长度为L0;直径小的弹簧其自由长度为L2,压紧长度也为L0;连接套桶的长度大约等于L0。那么装配在一起的弹簧总自由长度就是L1+L2-L0。其压紧后的长度就是L0。则弹簧在工作状态的总压缩长度L=L1+L2-2×L0。
如果L1=200MM,L2=150MM,L0=25MM,L=200+150-50=300MM
假如弹簧的行程是△L=20MM
误差=△L/L=20÷300=0.067=±3.3%
如果不用复合弹簧设计,而是用单个弹簧,那么
L=200-25=175MM
相同的行程:△L=20MM
因此就会得到一个大得多的误差=△L/L=20÷175=0.114=±5.7%
还如图1所示,在药物腔30的药液流体接收方向设置有限流器50,用于限制从药物腔30推送出的药液的流量。限流器50通过常规的连接部件60和药物腔30流体相通。连接部件60例如可用适合药物的塑胶材料比如聚丙烯等制成。
在一个实施方式中,限流器50可具有毛细管的构造,从而利用毛细管限流作用,即用长度补偿内径误差达到精确恒流效果。流体经过一个截面为圆形的细管时,如果流速很慢,则这样的流动属于层流。圆管内流体的流量与管两端的压力差,流体本身的粘性,管子的长度,和圆管的直径有关。将其用作限流器时,其确切流量可由下面的方程式计算:
Q=0.014625×(D4×ΔP)/(η×L)
Q 流量(μL/day)
ΔP 限流器50上的压降(psi)
η 流过限流器50的液体的黏度(cp)
L 限流器50的圆管长度
D 圆管的半径(μm)
在另一个实施方式中,限流器50可包括细管501和插入到毛细管501中的柱体(例如金属丝)502。细管501与插入的柱体502之间形成允许药液流通的间隙。例如,细管501可例如为圆管,柱体502可例如是圆柱体,则圆管和插入的圆柱体就形成环状流管式限流器,图3为管式限流器的平面示意图。
如图3所示,限流器50通过圆管和圆柱的叠加长度L来调节限流器的流量。应该理解,叠加长度L可根据具体的需要预先进行设定。在流速缓慢(层流)时,环状流管内的液体流动规则为:
Q=(πΔP)/8ηL[Ro4-Ri4–(Ro2–Ri2)2/Ln(Ro/Ri)]
Q 流量
Δp 限流器上的压降
H 流过限流器液体的黏度
L 限流器长度:圆管和圆柱的叠加长度
Ro 圆管的半径
Ri 圆柱的半径
Ln 是以e为底自然对数
再回到图1,在限流器50的流体流出方向上还可以留置针软管70,用于通过连接到该接口上的针将药液输送到人体。针软管70可通过常规的连接手段与限流器50流体相通而连接在一起。
根据本申请的一个实施方式,如图4所示,药物注射器100可设置在基底80上,基底80具有预设的开口使得针软管70从中穿过。可通过在基底80底部设置例如胶布的粘结部件90,而将药物注射器100粘贴在患者皮肤上,药物由留置软管70进入病人体内,从而使患者可以自由的在其正常生活和工作状态中得到可靠和有效的治疗。
以上对本申请实施方式的药物注射器和药物注射器系统进行了说明,然而,应该理解,以上所述仅为实现本发明的实施例而已,并不用以限制本发明。凡在本发明的精神和原则之内对本发明所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。

Claims (9)

1.药物注射器,包括具有容积空间的药物容器(10)以及在所述容积空间中设置有活塞(20),其中,在所述容积空间位于所述活塞的一侧为用于容纳药物的药物腔(30),而在所述活塞(20)的另一侧上设置有恒力提供装置(40),用于向所述活塞(20)提供恒定的推力,以推动所述活塞(20)沿着容积空间的延伸方向移动,从而通过改变所述药物腔(30)的容积将所述药物腔(30)中的药物推出,
其中,所述恒力提供装置(40)包括:
套筒(401);以及
设置在所述套筒(401)上相互邻接的第一弹簧(402)和第二弹簧(403),
其中,所述第一弹簧(402)具有比第二弹簧(403)小的剖面,从而使得在所述第一弹簧和所述第二弹簧被压缩时,受到压缩的第一弹簧收缩到受到压缩的第二弹簧内,
所述药物腔(30)由所述药物容器(10)的内侧部与所述活塞限定,以及
所述恒力提供装置的与所述活塞相对的一端直接抵靠所述药物容器(10)的内侧部。
2.如权利要求1所述的药物注射器,其中,所述恒力提供装置可包括大压缩比、短距离行程的恒力弹簧。
3.如权利要求1所述的药物注射器,其中,所述第一弹簧(402)和所述第二弹簧(403)的刚性系数相同。
4.如权利要求1-3中任意一项权利要求所述的药物注射器,还包括:
限流器(50),设置在所述药物腔(30)的药液流体接收方向,用于限制从所述药物腔(30)推送出的药液的流量。
5.如权利要求4所述的药物注射器,其中,所述限流器具有细管的构造,从而利用毛细管的限流作用,使得药液的流量达到精确的恒流效果。
6.如权利要求4所述的药物注射器,其中,所述限流器包括:
细管,用于接收从所述药物腔(30)推送出的药液;
柱体,设置于所述细管内,与所述细管的内管壁形成允许所述接收的药液通过的间隙。
7.如权利要求6所述的药物注射器,其中,所述柱体位于所述细管内的长度预先设定,从而调节通过所述间隙的药液流量。
8.如权利要求6所述的药物注射器,其中,在所述限流器(50)的流体流出方向上具有针软管(70),用于通过连接到该软管上的针将药液输送到人体。
9.一种药物注射器系统,包括:
如权利要求1-8中任意一项所述的药物注射器;以及
基底(80),用于支撑所述药物注射器,并具有预设的开口使得所述药物注射器的针软管(70)从中穿过。
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