CN1774275A - 控制体积的注射/抽吸装置 - Google Patents

控制体积的注射/抽吸装置 Download PDF

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CN1774275A
CN1774275A CNA2004800103303A CN200480010330A CN1774275A CN 1774275 A CN1774275 A CN 1774275A CN A2004800103303 A CNA2004800103303 A CN A2004800103303A CN 200480010330 A CN200480010330 A CN 200480010330A CN 1774275 A CN1774275 A CN 1774275A
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plunger rack
syringe
injection
shell
controlling organization
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S·J·杰龙德尔
S·D·金梅尔
J·费尔德
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Allergan Inc
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Allergan Inc
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    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • A61M5/3158—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • 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
    • A61M5/31—Details
    • A61M5/3148—Means for causing or aiding aspiration or plunger retraction
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3156—Mechanically operated dose setting member using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir

Abstract

一种控制体积的注射/抽吸装置，包括注射器，其具有用于容纳药物的本体，一个针头和一个滑动地置于本体内的活塞。提供一个用于容纳注射器本体的壳，并且一个内芯齿条置于壳内。一个手动操作的控制机构与内芯齿条成可操作关系被放置，该控制机构用于正向步进地移动内芯齿条而使得活塞将不连续剂量的药物从注射器本体通过针头射出。手动操作的控制机构也能可操作地反向步进地移动活塞而使得活塞将流体通过针头吸入注射器本体。

Description

控制体积的注射/抽吸装置
本申请是2003年4月16日提出申请的、序列号为60/463,638的、美国临时专利申请的继续申请，该申请通过引用的方式全部纳入本说明书。
技术领域
本发明总体涉及一种多剂量注射装置，更具体地说，涉及一种适合将所需量的BOTOX准确布置到特定肌肉组织的多剂量注射分配笔。
背景技术
目前注射BOTOX的方法采用注射器，其注射量由使用者在标示在注射器侧面的刻度处停止的能力来控制。
化学去神经剂例如肉毒杆菌毒素的局部施用经常通过皮下注射、肌肉注射、肌肉旁(paramuscular)注射或经皮注射(percutaneousinstallation)来实施。当通过皮下注射时，化学去神经剂以灌注方式抵达肌肉。
通常，采用多次小剂量的注射治疗特定的部位，其中每次注射剂在大约5微升到大约1毫升之间的范围内。
如上所述，此前的采用常规注射器的方法难于稳定一致地控制小量注射的剂量。
本发明提供一种控制体积的注射/抽吸装置，用于将化学去神经剂例如肉毒杆菌毒素有效地施用到选定部位。
发明内容
本发明的控制体积的注射/抽吸装置总体包括一注射器，所述注射器具有用于容纳药物的本体，针头以及可滑动地置于本体内的活塞。
提供了一个带有针头的用于接收注射器本体的壳，针头从所述壳伸出。置于壳内的用于移动活塞的内芯齿条是可滑动的，并且手动操作的控制机构与内芯齿条成可操作关系被放置，该控制机构用于正向步进地移动内芯齿条使得活塞将注射器本体中的药物通过针头射出，以及反向步进地移动内芯齿条使得活塞将流体通过针头吸入注射器本体。
更具体地说，所述装置可以包括一个置于壳上的窗口，使得可以观察吸入注射器本体的流体。该特征使得使用者可以通过这样的吸入来确定针头的方位。例如，如果吸入后通过窗口可以观察到血液，则使用者-医生将会改变针尖的方位，以避免将BOTOX直接注射到血管中。
更具体地说，所述控制机构包括一个注射爪，该注射爪用于与内芯齿条啮合以将内芯齿条在正向步进移动，并在反向步进移动时与内芯齿条脱离。
另外，设置一个抽吸爪，该抽吸爪用于与内芯齿条啮合以将内芯齿条在反向步进移动，并在正向步进移动时与内芯齿条脱离。
通过控制内芯齿条与爪的尺寸，所述控制机构被构造为注射在大约5微升到大约1毫升范围内的药物。
优选地，所述控制机构被构造为手指操作，以便整个注射和抽吸过程可以通过单手操作进行。另外，注射器可以是常规设计或专用的BOTOX设计，并可从壳中拆下。由这一点，本发明进一步独立地包括壳、内芯齿条和手动操作的控制机构。
附图说明
参照以下详细说明并结合附图，可以更清楚地理解本发明，所述附图中：
图1是根据本发明的控制体积的注射/抽吸装置的透视图，总体显示了从壳中伸出的针头和手动地可啮合扳柄；
图2是图1所示装置的横截面图，该图示出了置于装置壳内的、带有从壳中伸出的针头的注射器本体；和在中性位置显示的带有注射爪和抽吸爪的操作控制机构，该注射爪和抽吸爪用于选择性地与内芯齿条啮合，该内芯齿条操作活塞将药物从注射器本体中射出和将流体吸入注射器本体；
图3是图1和图2所示装置在注射过程中的视图，该图中扳柄被正向移动，注射爪与内芯齿条啮合以将活塞在正向移动；
图4是与图1-3类似的装置的视图，示出了在扳柄被反向移动且抽吸爪与内芯齿条啮合时从体内(未示出)抽吸流体。
具体实施方式
参见图1，其中示出了根据本发明的控制体积注射/抽吸装置10，总体显示了注射器12和针头14，以及用于容纳注射器本体20的壳，见图2-4。
如图2-4所示，注射器12包括滑动地置于注射器本体24内的活塞24，该活塞用于推动药物使药物通过针头14。内芯齿条28滑动地置于壳18中，并在其前端30处与活塞24连接。
如以下更加详细描述的，与内芯齿条28以可操作关系放置手动操作的控制机构34，以便如图3中箭头38所示的正向移动内芯齿条28，使得活塞24将不连续剂量的药物从注射器本体20通过针头14射出；并且如图4中箭头40所示的反向移动活塞24，将不连续剂量的流体通过针头14吸入注射器本体20中。
为了观察从体内(未示出)被抽出或吸出的流体，在壳上设置了窗口44。如上所述，用于在注射前从体内抽吸流体的活塞的这种反向运动会产生用于药物注射的针头的正确方位的提示，所述药物优选肉毒杆菌毒素。
操作控制机构34包括可从壳18外用手接触到的按钮48和控制杆50。注射爪54被枢轴56固定在控制杆的一个末端58并且转动受限，以使按钮48从中性位置的如图2所示的正向运动使得注射爪54与内芯齿条的齿62啮合。
内芯齿条28和活塞24的正向移动被限定为不连续的量，所述不连续的量由按钮48和壳18的前表面66之间的间距限定。这样，按钮沿箭头38方向的正向移动引起内芯齿条和活塞的受限或不连续的移动，由此使得不连续的度量的药物剂量通过针头14被射出。
如图2所示，按钮48和杆从图3所示的位置反向移动到中性位置，使得注射爪浮在齿62上。当按钮48再次沿箭头38方向正向移动时，注射爪54再次与齿62啮合。
这样，可以重复地将不连续量的药物注射到病人(未示出)的选定部位(未示出)。该不连续的剂量优选在大约5微升到大约1毫升范围内，该剂量由按钮48可获得的移动限定。
参见图4，当按钮48被沿箭头40方向移动越过图2所示的中性位置时，控制杆末端与抽吸爪接合，并通过使抽吸爪70围绕枢轴72的旋转使其与内芯齿条的齿62啮合。在该移动中，注射爪54与内芯齿条的齿62脱离。该移动使得活塞从本体20内抽出，并通过针头14将流体吸入注射器本体20内，所述流体可以通过窗口44观察到。
注射/抽吸装置10可以预先充有肉毒杆菌毒素，其可以是一次性的，或可替换地，注射器12可从壳19中拆下。在该实施方案中，可以将再次充满的注射器12和针头提供给壳18以及用于随后的多次肉毒杆菌毒素注射的操作控制机构34。
还应理解的是，本发明的元件可以用任何适合医药用途的材料制成。
虽然为了示出本发明具有优势的使用方式，以上描述了本发明的一种具体的控制体积的注射/抽吸装置，但应理解的是，本发明并不限于该装置。也就是说，本发明可以适当地包括所引述的组件、由或主要由所引述的组件组成。而且，可以在没有未在此具体公开的任何元件的条件下而实施在此示例性公开的本发明。因此，对于本领域普通技术人员来说任何和所有可能的改型、变型和等价方案都可以视为在所附权利要求限定的本发明的范围内。

Claims (8)

1.一种控制体积的注射/抽吸装置，包括：
注射器，具有用于容纳药物的本体、针头和可滑动地置于所述本体内的活塞；
用于接收所述带有针头的注射器本体的壳，所述针头从所述壳中伸出；
滑动地置于所述壳内、用于移动所述活塞的内芯齿条；和
与所述内芯齿条成可操作关系放置的手动操作的控制机构，用于正向步进地移动所述内芯齿条，使得所述活塞将不连续剂量的药物从注射器本体通过针头射出，并且反向步进地移动内芯齿条，将不连续剂量的流体通过针头吸入注射器本体中。
2.根据权利要求1的装置，还包括置于所述壳上的窗口，使得可以观察吸入注射器本体的流体。
3.根据权利要求1的装置，其特征在于，控制机构包括一个注射爪，该注射爪用于与所述内芯齿条啮合以将所述内芯齿条在所述正向步进移动，并在所述反向步进移动时与所述内芯齿条脱离。
4.根据权利要求3的装置，其特征在于，控制机构包括一个抽吸爪，该抽吸爪用于与所述内芯齿条啮合以将所述内芯齿条每次在所述反向步进移动，并每次在所述正向步进移动时与所述内芯齿条脱离。
5.根据权利要求1的装置，其特征在于，控制机构被构造为用于注射在大约5微升到大约1毫升范围内的药物。
6.根据权利要求1的装置，其特征在于，药物包括BOTOX。
7.根据权利要求1的装置，其特征在于，控制机构被构造为手指操作。
8.根据权利要求1的装置，其特征在于，所述注射器可从所述壳中拆下。
CNA2004800103303A 2003-04-16 2004-04-15 控制体积的注射/抽吸装置 Pending CN1774275A (zh)

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US60/463,638 2003-04-16

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EP (1) EP1613377A1 (zh)
JP (1) JP2006523518A (zh)
KR (1) KR20050122256A (zh)
CN (1) CN1774275A (zh)
AU (1) AU2004231966A1 (zh)
BR (1) BRPI0409478A (zh)
CA (1) CA2522528A1 (zh)
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US7641637B2 (en) 2010-01-05
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US7364570B2 (en) 2008-04-29

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