CN1863564A - Patch-like infusion device - Google Patents

Patch-like infusion device Download PDF

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Publication number
CN1863564A
CN1863564A CN 200480029220 CN200480029220A CN1863564A CN 1863564 A CN1863564 A CN 1863564A CN 200480029220 CN200480029220 CN 200480029220 CN 200480029220 A CN200480029220 A CN 200480029220A CN 1863564 A CN1863564 A CN 1863564A
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China
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container
needle
position
body
spring
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CN 200480029220
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Chinese (zh)
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CN100509069C (en
Inventor
C·钦德里奇
R·松德雷格
G·豪厄尔
W·哈丁
A·拉斯托维奇
L·韦德里纳
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贝克顿·迪金森公司
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Priority to US49428603P priority Critical
Priority to US60/494,286 priority
Priority to US60/558,611 priority
Application filed by 贝克顿·迪金森公司 filed Critical 贝克顿·迪金森公司
Publication of CN1863564A publication Critical patent/CN1863564A/en
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Publication of CN100509069C publication Critical patent/CN100509069C/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
    • 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
    • A61M2005/1426Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with means for preventing access to the needle after use

Abstract

A system and method for a patch-like, self-contained substance infusion device (100) which provides one or more substantially hidden patient needles (141) which can be placed in fluid communication with a fluid reservoir assembly that includes a rigid bladder portion (151) used in conjunction with a non-distensible bladder film (151), such as a metallized film. The device (100) can be attached to a skin surface via an adhesive contact surface and a push button (105) activation assembly can then be used to remove an interlock (135), allowing a disk, or Belleville spring (130) assembly to apply an essentially even and constant pressure to the contents of a fluid reservoir assembly. The push button activation assembly further allows the release of one or more spring-loaded patient needles (141) into the skin surface, and establishes a fluid communication path between the patient needles (141) and the pressurized fluid reservoir contents (150) thereby delivering an infusion into the skin. The push button activation assembly further allows the release of one or more improved safety mechanisms after use.

Description

片状输液装置 Sheet-infusion

技术领域 FIELD

本发明通常涉及具有改良阀、弹簧和安全机构的物质输送装置,并且还涉及可用于向患者输送各种物质或药物的片状的、整装的物质输液装置。 The present invention generally relates to a substance delivery device having improved valves, a spring and a safety mechanism, and also to the substance infusion device may be used to transport various substances or drugs to a patient a sheet-like self-contained. 本申请根据35U.SC§119(e)要求优先于Chris Cindrich等人在2003年8月12日申请的序列号为No.60/494,286的题为“Patch-Like Infusion Device”的美国临时专利申请以及ChrisCindrich等人在2004年4月2日申请的序列号为No.60/558,611的题为“Patch-Like Infusion Device With Improved Valve,Spring AndSafety Mechanisms”的美国临时专利申请的优先权,这里合并参考每个所述专利的全部内容。 This application is based on 35U.SC§119 (e) requires the serial number in preference to Chris Cindrich et al., 2003 August 12 filed No.60 / 494,286, entitled "Patch-Like Infusion Device" of US Provisional Patent Application and the serial number ChrisCindrich et al, 2004 April 2 filed No.60 / 558,611, entitled priority "Patch-Like Infusion Device With Improved Valve, Spring AndSafety Mechanisms" of US provisional Patent application, incorporated herein by reference the entire contents of each patent. 该申请包含与Charles D.Shermer等人在2003年7月22日申请的序列号为No.10/623,702的题为“Patch-LikeInfusion Device”的美国非临时专利申请相关的主题,这里合并参考所述专利的全部内容。 The US non-provisional patent application contains Charles D.Shermer et al application July 22, 2003 Serial No. No.10 / 623,702, entitled "Patch-LikeInfusion Device" application-related topics, are incorporated by reference herein the entire contents of said patent.

背景技术 Background technique

很多人,诸如那些处于诸如患有糖尿病状态下的人使用某种形式的输液疗法(诸如每日胰岛素注射)以保持其葡萄糖水平的严密控制。 Many people, such as those in infusion therapy (such as daily insulin injections), such as people suffering from diabetes under some form of state to maintain tight control of their glucose levels. 当前,在胰岛素注射治疗示例中,存在两种每日胰岛素疗法的主要模式。 Currently, insulin injections example, there are two main modes daily insulin therapy. 第一种模式包括注射器和胰岛素笔。 The first mode includes syringes and insulin pens. 这些装置使用简单并且成本较低,但是它们在通常为每天三到四次的每次注射时都需要针刺入。 These devices are simple to use and low cost, but they are generally three to four times a day when each injection needle into the need. 第二种模式输液泵疗法,所述疗法需要购买可使用约三年的昂贵的泵。 The second mode is infusion pump therapy, the therapy requires the purchase of expensive pump may be used from about three years. 所述泵的原始成本对于这种类型的疗法来说具有高的障碍。 Initial cost of the pump has a high barrier to this type of therapy is. 然而,从使用者的观点来看,已使用泵的多数患者宁愿利用泵维持他们余下的生命。 However, from the user's point of view, the pump has been used in most patients prefer to use a pump to maintain the rest of their lives. 这是由于尽管输液泵比注射器和胰岛素笔更复杂,但是其具有连续注入胰岛素、精确的剂量以及程序化输送时间表等优点。 This is because infusion pumps although more complex than syringes and insulin pens, but with continuous infusion of insulin, precise dosage of the transportation schedule and a program and so on. 这导致更严密的葡萄糖控制和提高的健康感觉。 This results in tighter glucose control and increase the feeling of wellness.

当口服药剂的患者最终转为胰岛素并且他们对于增强治疗的兴趣增加时,使用者通常关注胰岛素泵。 When patients on oral agents and insulin, ultimately, to increase their interest in enhancing treatment, users often focus on insulin pump. 然而,除了胰岛素泵的高成本(大约为注射器疗法的日常成本的8到10倍)和有限使用寿命之外,胰岛素泵还体现了较古老的技术并且使用起来麻烦。 However, in addition to the high cost than insulin pump (syringe therapy daily about 8 to 10 times the cost) and limited lifetime, insulin pumps also reflected a more ancient technique and cumbersome to use. 另外,从生活方式的观点来看,使得泵与安放在使用者腹部上的输送部分相连接的管(称之为“输液装置”)非常不方便,并且所述泵较重,因此所述泵的携带成为负担。 Further, from the viewpoint of lifestyle, so that the tube pump mounted on the user and the delivery section connected to the abdomen (called "infusion device") is very inconvenient, and the pump is heavy, so the pump It is carrying a burden.

因此考虑到泵疗法的可观增长和日注射量的增加,对于更好疗法的期待日益增长。 Therefore, taking into account the considerable increase in growth in pump therapy and daily injection volume, growing expectations for better therapies. 在该注射示例和相似的注射示例中,完全满足该增长期待的是一种形式的胰岛素输入或注入,所述形式组合了每日注射疗法(低成本并且易于使用)的最佳特征与胰岛素泵的最佳特征(连续注入和精确的剂量)并且还避免了每种疗法的缺点。 In this example and similar injection injections example, to fully meet the growing expectations of an input or injection forms of insulin, a combination of a daily injection therapy (low cost and easy to use) with the best features of the insulin pump the best characterized (continuous injection and the precise dosage) and further avoids the disadvantages of each therapy.

已提出了几种建议,即,提供成本低廉并且便于使用的不需卧床或“可佩带的”药物输液装置。 Several suggestions have been proposed, i.e., to provide low cost and facilitate the drug infusion ambulatory or "wearable" as used. 这些装置中的某些被定为部分或全部是一次性的。 Some of these devices is given partially or entirely disposable. 理论上,这种类型的装置可提供输液泵的许多优点而没有附加成本和不便利性。 In theory, devices of this type can provide many advantages of an infusion pump without the additional cost and inconvenience. 然而,不幸的是,这些装置中的许多都具有包含(由于所使用的注射针的规格和/或长度导致的)使用者不舒适感、待输送的物质与输液装置的构成中所使用的材料之间的相容性和相互作用、以及如果使用者不适当启动的话可能出现故障(例如,由于装置的过早启动导致的“潮湿”注入)等缺点。 Unfortunately, however, many of these devices have a containing (due to size and / or length of the needle used due to) the user discomfort, and the material substance infusion device to be used in the delivery compatibility and interactions between, and if a user initiated an inappropriate words may fail (e.g., due to premature start of the apparatus "wet" due to the injection) and other shortcomings. 在制造和控制针刺入深度方面也遭遇了困难,尤其是在使用较短和/或细规格注射针时。 In the manufacture of needle penetration depth control and also encountered difficulties, especially when using short and / or fine gauge needle. 针刺可能伤害到与所用装置相接触的人也是个问题。 Acupuncture possible injury to persons in contact with the apparatus used is a problem.

因此,存在对于当前输液装置(诸如用于胰岛素所输液泵)的替代需求,并且还提供了对于胰岛素和非胰岛素应用在制造方面的简单性和使用进步。 Accordingly, there is need for a substitute (such as for insulin infusion pump) for the current infusion device, and also provides for the simplicity and the use of insulin and non-insulin-progress application in manufacturing.

发明内容 SUMMARY

本发明的一个目的是提供一种片状输液装置,所述装置可便利地佩带在皮肤上,同时提供所需物质的注入,并且通过使用一个或多个微型针提供最小的不舒适性。 An object of the present invention is to provide a sheet-infusion device, the device may conveniently be worn on the skin, while providing the desired substance is injected, and to provide minimal discomfort by using one or more of the microneedles.

本发明的另一个目的是提供一种片状输液装置,所述装置在使用之前和使用期间提供了与传统注射针不同的隐蔽针。 Another object of the present invention is to provide a sheet-infusion device, the device is provided prior to use with a conventional needle and needle of different obscured during use.

本发明的另一个目的是提供一种片状输液装置,所述装置可通过粘着表面被固定于患者,之后通过启动步骤进行内容物容器的加压、患者针植入以及容器内容物的输送。 Another object of the present invention is to provide a sheet-infusion device, the device may be secured to the patient via an adhesive surface, followed by a pressurized contents of the container through the start-up procedure, the implant and patient needle delivery of the container contents.

本发明的另一个目的是提供一种片状输液装置,所述装置使用囊状物和贝氏弹簧或其他盘状弹簧组件为内容物容器加压。 Another object of the present invention is to provide an infusion device of a sheet, the apparatus uses capsules and Belleville spring or other spring assembly is a disc-shaped pressurized contents of the container.

本发明的另一个目的是提供一种片状输液装置,所述装置通过移开贝式弹簧保持盘对内容物容器的内容物进行加压。 Another object of the present invention is to provide a sheet-infusion device, said disk device and the contents of the pressurized contents of the container by removing a Belleville maintained.

本发明的另一个目的是提供一种片状输液装置,所述装置可通过在启动步骤中施加于竖直或水平推动表面的适当的力被启动。 Another object of the present invention is to provide a sheet-infusion device, the device can be applied to vertical or horizontal surface of the force pushing the appropriate starting step is started.

本发明的另一个目的是提供一种片状输液装置,所述装置可在使用之前、使用期间以及使用之后对装置内容物进行直观检查。 Another object of the present invention is to provide a sheet-infusion device, the device may be used prior to, during use, and after use of the contents of the device for visual inspection.

本发明的另一个目的是提供一种片状输液装置,所述装置可在一个或多个操作中移除患者针帽和/或粘合剂盖。 Another object of the present invention is to provide a sheet-infusion device, the device may be removed patient needle cap and / or one or more adhesive cover operations.

本发明的另一个目的是提供一种片状输液装置,所述装置有助于进行自注入并且减小或消除使用者之间在注射技术方面的不同。 Another object of the present invention is to provide a sheet-infusion device, said means facilitates the self-injection and reduces or eliminates the difference between a user injection technology.

本发明的另一个目的是提供一种片状输液装置,所述装置包括改良的防护机构,所述防护机构用于在有意或无意下从皮肤表面移除时保护患者针。 Another object of the present invention is to provide a sheet-infusion device, the device comprising an improved protection means, said protection means for protection of a patient intentionally or unintentionally at the time the needle is removed from the skin surface.

本发明的另一个目的是提供一种片状输液装置,所述装置包括改良的阀机构,所述阀机构用于在装置使用之前和使用期间提供无菌挡板和压力密封。 Another object of the present invention is to provide a sheet-infusion device, said means comprising a modified valve mechanism, the valve mechanism for providing a sterile baffle and pressure prior to use and during use of the sealing means.

本发明的另一个目的是提供一种片状输液装置,所述装置包括用于与输液装置结合使用的改良的贝式弹簧和弹簧销机构。 Another object of the present invention is to provide a sheet-infusion device, said means comprising a modified apparatus for use in conjunction with an infusion of the Belleville spring and pin mechanism.

本发明的另一个目的是提供一种片状输液装置,所述装置包括改良的模制技术以更好地利用结构材料。 Another object of the present invention is to provide a sheet-infusion device, the device comprising an improved molding techniques to make better use of structural materials.

本发明的另一个目的是提供一种片状输液装置,所述装置包括改良的微型针构成技术和材料。 Another object of the present invention is to provide a sheet-infusion device, said means comprising a modified microneedle configuration techniques and materials.

本发明的另一个目的是提供一种片状输液装置,所述装置包括改良的启动机构,所述启动机构包括枢轴臂和磁性设备。 Another object of the present invention is to provide a sheet-infusion device, said pivot arm means comprises a magnetic device and an improved actuating mechanism, said actuation mechanism comprises a.

本发明的另一个目的是提供一种片状输液装置,所述装置包括改良的多样弹簧机构。 Another object of the present invention is to provide a sheet-infusion device, said means comprising a spring mechanism variety improvement.

本发明的另一个目的是提供一种片状输液装置,所述装置包括改良的装料机构、装料指示器以及无菌包装。 Another object of the present invention is to provide a sheet-infusion device, the device comprising an improved charge means, the charge indicator and sterile packaging.

通过提供用于片状、可佩带、整装的物质输液装置的系统和方法基本上实现了这些和其他目的,所述物质输液装置提供了一个或多个基本隐蔽的患者针,所述患者针可被布置得与内容物容器组件流体连通,所述内容物容器组件包括与诸如金属膜等不可扩展囊状膜结合使用的刚性囊状部分。 By providing a sheet-like, wearable, a system and method for self-contained substance infusion device substantially achieves these and other objects, the substance infusion device is provided with one or more substantially hidden patient needle, the patient needle may be arranged in fluid communication with the contents of the container assembly, the contents of the container assembly includes a rigid portion of a bladder used in conjunction with a metal film such as a capsule membrane can not be extended. 提供了推动类型的启动组件,所述启动组件可用于移开保持销并且使得贝式弹簧组件向容器组件的内容物施加基本均匀且恒定的压力。 Providing a push type activation assembly, said activation assembly may be used to remove the retaining pin assembly and the Belleville applied such that a substantially uniform and constant pressure to the contents of the container assembly. 之后所述推动类型的启动组件释放一个或多个弹簧承载患者针并且使得所述患者针位于患者的皮肤中并且在患者针与加压所容器内容物之间形成流体通路,从而将内容物浸液输送到使用者的皮肤中。 After the start of the push type component releasing one or more spring-loaded needle and the patient such that the patient needle is in the patient's skin and a fluid passageway between the patient and the needles of the pressurized contents of the container, whereby the contents were immersed It was delivered to the user's skin. 在输液装置完成并移除时,可接上多个安全机构以覆盖一次性针。 Upon completion of the infusion device and removed, can be connected to a plurality of disposable needle covering safety mechanism.

附图说明 BRIEF DESCRIPTION

从以下结合附图所作出的详细描述中将明白本发明优选实施例的各种目的、优点和新颖特征,其中:图1是在启动之前使用侧部按钮表面的片状注射器或输液系统的第一实施例的横截面图;图2是在启动之后使用侧部按钮表面的片状注射器或输液系统的第一实施例的另一个横截面图;图3是图1的片状注射器或输液系统的容器子配件的横截面图;图4是图1的片状注射器或输液系统的贝式弹簧子配件的横截面图;图5是处于关闭位置中的图1的片状注射器或输液系统的推动阀子配件的第一实施例的横截面图; Understood that various objects, advantages and novel features of the preferred embodiment of the present invention, wherein from the detailed description made below in conjunction with the accompanying drawings: FIG. 1 is a syringe or an infusion system of the sheet-like surface of the side portion of the button before starting another cross-sectional view of a first embodiment of an infusion system or the like injector of FIG 2 using a side surface portion of the push button after activation;; a cross-sectional view of the embodiment of FIG. 3 is a sheet or a syringe infusion system of FIG. 1 a cross-sectional view of the container subassembly; FIG. 4 is a cross-sectional view of a Belleville like injector subassembly or infusion system of FIG. 1; FIG. 5 is a sheet-like syringe or an infusion system closed position in FIG. 1 a cross-sectional view of the push valve embodiment a first subassembly;

图6是处于打开位置中的图1的片状注射器或输液系统的推动阀子配件的第一实施例的横截面图;图7是图1的片状注射器或输液系统的拉阀子配件的第二实施例的横截面图;图8是图1的片状注射器或输液系统的推/拉阀子配件的第一实施例的横截面图;图9是在启动之前使用顶部按钮表面的片状注射器或输液系统的第二实施例的横截面图;图10是在启动之后图9的片状注射器或输液系统的第二实施例的横截面图;图11是从图9的片状注射器或输液系统的第二实施例的容器子配件的第一透视角看过去的顶视图;图12和13是使用顶部按钮表面的片状注射器或输液系统的第二实施例的另一种型式的分解图;图14是在启动之前从图12的片状注射器或输液系统的第一透视角看过去的顶视图;图15是在启动之前图12的片状注射器或输液系统的横截面图;图16是在启动之前图12的 FIG 6 is a cross-sectional view of a first embodiment of a sheet urging the valve subassembly of the syringe or an infusion system in an open position of FIG. 1; FIG. 7 is a pull valve or infusion sub-like injector system of Figure 1 fitting a cross-sectional view of a second embodiment; FIG. 8 is a push / cross-sectional view of a first embodiment of a sheet to pull the valve subassembly of the syringe or infusion system of FIG. 1; FIG. 9 is a sheet of a top surface of the button before starting a cross-sectional view of a second embodiment of an infusion syringe or like system; FIG. 10 is a cross-sectional view of a second embodiment of an infusion system or the like injector of Fig. 9 after activation; FIG. 11 is a sheet from the syringe of FIG. 9 or the first perspective of a second embodiment of the container subassembly of the infusion system is viewed over a top view; FIGS. 12 and 13 is another version of the second embodiment using the top surface of the button syringe or a sheet transfer system exploded view; FIG. 14 is a top view of the watch before starting over from a first perspective of a syringe or a sheet transfer system of FIG. 12; FIG. 15 is a cross-sectional view of a syringe or a sheet transfer system 12 before starting; FIG 16 FIG 12 is started before the 状注射器或输液系统的侧视图;图17是在启动之前图12的片状注射器或输液系统的另一个横截面图;图18是在启动之后从图12的片状注射器或输液系统的第一透视角看过去的顶视图;图19是在启动之后图12的片状注射器或输液系统的横截面图;图20是在启动之后图12的片状注射器或输液系统的侧视图;图21是在启动之后图12的片状注射器或输液系统的另一个横截面图;图22(a)到22(e)是图12的片状注射器或输液系统的容器子配件的多个图;图23是处于关闭位置中的图12的片状注射器或输液系统的阀子配件的横截面图;图24是处于打开位置中的图12的片状注射器或输液系统的阀子配件的横截面图;图25是片状注射器或输液系统的第三实施例的分解图;图26是在启动之前图25的片状注射器或输液系统的横截面图;图27是在启动之后图25的片状注射器或输液系统的横截面 A side view of a syringe-like or an infusion system; FIG. 17 is a cross-sectional view of another syringe or a sheet transfer system 12 before starting; FIG. 18 is started after the sheet from the first syringe or an infusion system 12 of FIG. see the perspective of a top view of the past; FIG. 19 is a cross-sectional view of a syringe or a sheet transfer system of FIG. 12 after activation; FIG. 20 is a side view of a sheet-like syringe or an infusion system of FIG. 12 after activation; FIG. 21 is after the start of another cross-sectional view of the sheet-like syringe or an infusion system of FIG. 12; FIG. 22 (a) to 22 (e) is a view of a container subassembly plurality of sheet-like syringe or an infusion system of FIG. 12; FIG. 23 It is a cross-sectional view of a valve closed position in FIG sheet syringe subassembly 12 or infusion system; FIG. 24 is a cross-sectional view of the valve subassembly of the syringe or a sheet transfer system in an open position of Figure 12; FIG 25 is an exploded view of a third embodiment of a sheet-like syringe or an infusion system; FIG. 26 is a cross-sectional view of a syringe or a sheet transfer system 25 before starting; FIG. 27 is started after the sheet of FIG. 25 syringe cross section or transfer system 图;图28是在启动之前从片状注射器或输液系统的第四实施例的第一透视角看过去的顶视图;图29是在启动之后和缩回之前从图28的片状注射器或输液系统的第二透视角看过去的另一个顶视图;图30是在启动之后和缩回之前从图28的片状注射器或输液系统的第三透视角看过去的另一个顶视图;图31是在缩回之后从图28的片状注射器或输液系统的第四透视角看过去的另一个顶视图;图32是处于关闭位置中的图28的片状注射器或输液系统的阀子配件的横截面图;图33是处于打开位置中的图28的片状注射器或输液系统的阀子配件的横截面图;图34是从片状注射器或输液系统的第四实施例的另一种型式的第一透视角看过去的顶视图;图35是从图34的片状注射器或输液系统的第二透视角看过去的另一个顶视图;图36是从片状注射器或输液系统的第四实施例的另一种型式 FIG.; FIG. 28 is a top view of the watch before starting over from a first perspective of a fourth embodiment of the sheet-like syringe or an infusion system; FIG. 29 is retracted before and after starting from a sheet 28 of a syringe or infusion second perspective angle of view and a top view of the system in the past; FIG. 30 is retracted before and after starting viewed from the perspective of a third sheet-like syringe or an infusion system further top plan view of FIG. 28; FIG. 31 is after the retraction of the last look at another top view of a sheet from a fourth perspective of a syringe or an infusion system of FIG. 28; FIG. 32 is in the closed position of the valve subassembly of FIG syringe or a sheet transfer system 28 of the cross cross-sectional view; FIG. 33 is a cross-sectional view of the valve subassembly of the syringe or a sheet transfer system in an open position of FIG. 28; FIG. 34 is another version of the fourth embodiment of the sheet-like syringe or an infusion system a top perspective view of a first angle to see past; see FIG. 35 is a top view of a further perspective view from a second angle over a sheet-like syringe or an infusion system of FIG. 34; FIG. 36 is a fourth embodiment of a sheet from a syringe or an infusion system Examples of another type 第一透视角看过去的顶视图;图37是片状注射器或输液系统的第五实施例的横截面图;图38到41是具有扩展保险装置的图37的片状注射器或输液系统的横截面图;图42和43是图37的片状注射器或输液系统的容器子配件的顶视图; A top perspective view of a first angle to see past; FIG. 37 is a cross-sectional view of a fifth embodiment of the sheet-like syringe or an infusion system; FIGS. 38 to 41 are cross-like injector or infusion system having extended safety device 37 of FIG. cross-sectional view; FIG. 42 is a top view of the container 43 and the subassembly or syringe sheet transfer system of FIG. 37;

图44到48是处于关闭位置中的图37的片状注射器或输液系统的容器和阀子配件的横截面图;图49是图37的片状注射器或输液系统的两点注射患者针歧管子配件的横截面图;图50到54是从图40的片状注射器或输液系统的装配步骤的第一透视角看过去的视图;图55到60是贝式弹簧和随动器的横截面图;图61是处于关闭位置中的改良阀示例的第一变体的横截面图;图62是处于关闭位置中的改良阀示例的第二变体的横截面图;图63是处于关闭位置中的改良阀示例的第三变体的横截面图;图64是处于关闭位置中的改良阀示例的第四变体的放大横截面图;图65是改良阀示例的第五变体的放大横截面图,其中开口包括渐缩表面;图66是处于关闭位置中的图65的改良阀示例的横截面图;图67是处于打开位置中的图65的改良阀示例的横截面图;图68是图65的改良阀示例的横截面图, FIGS 44-48 is a cross-sectional view of the container and a valve or the like injector subassembly infusion system closed position of FIG. 37; FIG. 49 is a patient needle manifold subassembly two injection syringe or a sheet transfer system 37 of FIG. fitting cross-sectional view; FIG. 50 to 54 are views seen from the last assembly step of the first perspective of a syringe or a sheet transfer system of FIG. 40; FIGS. 55 to 60 are cross-sectional view of a Belleville and follower of ; FIG. 61 is a cross-sectional view of a first variant example of the valve closing position improvement; Figure 62 is a cross-sectional view of a second improved variant of the valve closing position of the example; FIG. 63 is in the closed position cross-sectional view of the third variant example of modified valve; in FIG. 64 is an enlarged cross-sectional view of a fourth variant example of the improved valve in a closed position; FIG. 65 is an enlarged cross variant of the fifth modified example of the valve sectional view, wherein the opening includes a tapered surface; FIG. 66 is a cross-sectional view of an improved valve exemplary closed position of FIG. 65; FIG. 67 is a cross sectional view of the improved valve is an example of an open position in FIG. 65; FIG. 68 is a cross sectional view of FIG modified example of the valve 65, 中开口包括渐缩和平坦表面;图69到71是改良阀柱塞杆示例的视图;图72到74是改良过度模制阀柱塞杆示例的视图;图75是改良旋转阀实施例的视图;图76是图75的改良旋转阀实施例的详细横截面图;图77是另一种型式改良旋转阀实施例和填充罩的横截面图;图78是另一种改良旋转阀实施例的透视图;图79(a)到79(c)是图77的改良旋转阀实施例的流体路径的第一、第二和第三阶段的横截面图;图80是处于关闭位置中的改良阀子配件的横截面图;图81是图80的处于打开位置中的改良阀子配件的横截面图;图82是处于固定位置中的改良贝式弹簧和销示例的横截面图; It includes a tapered opening and a flat surface; FIGS. 69 to 71 are views of modified example of the valve plunger rod; FIG. 72 to 74 are views overmolded modified example of the valve of the plunger rod; FIG. 75 is a view of a modified embodiment of the rotary valve ; FIG. 76 is a detailed cross-sectional view of the embodiment of FIG improved rotary valve 75; FIG. 77 is a cross sectional view of embodiment of the filler cover and another version of embodiment of an improved rotary valve; FIG. 78 is a diagram of another embodiment of an improved rotary valve perspective view; FIG. 79 (a) to 79 (c) is a cross-sectional view of the first, second and third phases of the fluid path embodiment of the modified embodiment of the rotary valve of FIG. 77; FIG. 80 is in the closed position of the valve modified cross-sectional view of the subassembly; FIG. 81 is a cross-sectional view in FIG improved valve subassembly 80 in the open position; FIG. 82 is a Belleville modified in a fixed position and cross-sectional view of an example of a pin;

图83是处于放松位置中的图82的改良贝式弹簧和销示例的横截面图;图84(a)到84(c)是第一、第二和第三改良贝式弹簧和销示例结构的透视图;图85是改良贝式弹簧和销示例结构的力矢量图;图86是在示例输液装置中处于固定位置中的改良贝式弹簧和销示例的横截面图,用于示出钮引起销放松;图87是处于放松位置中的图86的改良贝式弹簧和销示例的横截面图;图88是改良贝式弹簧和开口环销示例的横截面图;图89是图88的改良贝式弹簧和开口环销示例的第二横截面图;图90是本发明实施例所涉及的过度模制贝式弹簧的透视图;图91和92分别是处于放松和弯曲位置中的图90的过度模制贝式弹簧的横截面图;图93是使用贝式弹簧和销摩擦功能以便于将装置保持在启动状态下的装置示例的横截面图;图94是装置的改良容器示例的顶视图;图95是装置的改良臂/流体路径 FIG 83 is a cross-sectional view of a Belleville modified exemplary pin and relaxed position of FIG. 82; FIG. 84 (a) to 84 (c) first, second, and third modified example Belleville pin configuration and perspective view; FIG. 85 is a modified power pin and a Belleville exemplary configuration vector; FIG. 86 is a cross-sectional view of an example of a Belleville pin and modified fixed position in the exemplary infusion device, for illustrating button causing pin relax; FIG. 87 is in modified Belleville relaxed position of FIG. 86 and the pin example of a cross-sectional view; FIG. 88 is a cross-sectional view of an improved Belleville and split ring pin example; FIG. 89 is a diagram 88 modified and second Belleville ring opening cross-sectional view of an example of a pin; FIG. 90 is a perspective view of a Belleville overmolded according to an embodiment of the present invention; FIGS. 91 and 92 are in a relaxed and a bent position in FIG. cross-sectional view overmolded Belleville 90; FIG. 93 is the use of a Belleville spring and pin frictional functions to facilitate the means a cross-sectional view of an apparatus example held in a starting state; FIG. 94 is a modified container exemplary apparatus a top view; FIG. 95 is a modified arm assembly / fluid path 示例的顶视图;图96是图95的装置的改良臂/流体路径示例的横截面图;图97是处于非装配位置中的图94和95的改良容器和臂/流体路径示例的装配图;图98是处于装配位置中的图94和95的改良容器和臂/流体路径示例的装配图;图99是用于图98的容器和臂/流体路径组件示例的第一密封装置的横截面图;图100是用于图98的容器和臂/流体路径组件示例的第二密封装置的横截面图;图101到105是患者针歧管的结构示例的横截面图;图106是改良患者针头接口和歧管的横截面图; A top view of an example; FIG. 96 is a cross-sectional view of an improved arm apparatus of FIG. 95 / fluid path example; FIG. 97 is in a modified container non-mounting position in FIG. 94 and 95 and the assembly view of the arm / fluid path example; FIG 98 is a modified container in assembled position in FIG. 94 and FIG. 95 of the arm assembly and / example of a fluid path; FIG. 99 is a cross-sectional view of the container 98 and the first sealing means arm / fluid path components example ; Fig. 100 is a cross-sectional view of a second sealing means for the container and an arm / fluid path components of the example of FIG. 98; FIG. 101 to 105 are cross-sectional view showing a configuration example of a patient needle manifold; FIG patient needle 106 is modified and a cross-sectional view of the interface of the manifold;

图107是多孔患者微型针的视图;图108是具有多个侧孔的患者微型针的视图;图109和图110是具有枢轴臂组件的装置的横截面图;图111到115是具有磁性启动组件的装置的横截面图;图116(a)到116(c)是止转棒轭功能保险装置示例的示意图;图117是处于缩回状态下的缩回楔形防护物的透视图;图118是处于延伸状态下的图117的缩回楔形防护物的透视图;图119是图117的防护物的滑架返回机构的透视图;图120是处于初始位置中的缩回狭槽防护物的透视图;图121是处于在用位置中的图120的缩回狭槽防护物的透视图;图122是处于缩回位置中的图120的缩回狭槽防护物的透视图;图123是处于缩回状态中的斗形防护物的透视图;图124是处于延伸状态中的图123的斗形防护物的透视图;图125是未启动的装置中处于缩回状态中的图123的斗形防护物的透视性内部图;图126是启动的装置 107 is a view of a porous microneedle patient; FIG. 108 is a view of a patient having a plurality of micro-needle side hole; FIG. 109 and FIG 110 is a cross-sectional view of the apparatus having a pivot arm assembly; FIGS. 111-115 is a magnetic cross-sectional view of the apparatus initiating component; FIG. 116 (a) to 116 (c) is a diagram showing an example of apparatus scotch yoke safety function; FIG. 117 is a perspective view of the wedge is retracted in the shield retracted state; FIG. 118 is a perspective view of the wedge 117 is retracted in the shield extended state; FIG. 119 is a perspective view of the return mechanism of the carriage 117 of the shield; FIG. 120 is in an initial retracted position in the slot of shield perspective view; FIG. 121 is in the position in perspective view in FIG retracted shield slot 120; a perspective view of the retraction slots 122 is a shield in the retracted position of FIG. 120; 123 is a perspective view showing a state in bucket-shaped shield retracted; FIG. 124 is a perspective view of the bucket-shaped shield in the extended state of FIG. 123; FIG apparatus 125 is not started in the retracted state in FIG. 123 FIG perspective bucket-shaped interior of the shield; FIG apparatus 126 is activated 处于缩回状态中的图123的斗形防护物的透视性内部图;图127是启动的装置中处于延伸状态中的图123的斗形防护物的透视性内部图;图128是处于缩回状态中的棘轮锁定防护物的透视图;图129是处于延伸状态中的图128的棘轮锁定防护物的透视图;图130是图128的防护物的棘轮锁定机构的透视图;图131是处于缩回状态中的拉出防护物的透视图;图132是处于延伸状态中的图131的拉出防护物的透视图;图133是处于缩回状态中的另一个拉出防护物的透视图;图134是处于延伸状态中的图133的拉出防护物的透视图;图135是处于初始位置中的扭簧防护物的透视图;图136是处于在用位置中的图135的扭簧防护物的透视图;图137是处于缩回位置中的图135的扭簧防护物的透视图; In the retracted state in a perspective internal FIG bucket-shaped shield 123; FIG. 127 is a perspective view of the device of an internal promoter in the extended state of FIG bucket-shaped shield 123; 128 is retracted state ratchet locking a perspective view of the shield; Figure 129 is a perspective view of the shield in the extended state of FIG. 128 ratchet lock; FIG. 130 is a perspective view of the mechanism of the ratchet shield of FIG. 128 lock; FIG. 131 is in a perspective view of the shield is pulled out of the retracted state; FIG. 132 is a perspective view of FIG drawn shield 131 in an extended state; FIG. 133 is a perspective view of another drawn in the retracted state of the shield ; FIG. 134 is a perspective view of the shield is pulled out in the extended state of FIG. 133; FIG. 135 is a perspective view of the torsion spring in an initial position of the shield; FIG torsion spring 136 is in a position 135 in FIG. a perspective view of the shield; FIG. 137 is a perspective view of the torsion spring shield in the retracted position of FIG. 135;

图138是具有整体弹簧的铰接防护物的透视图;图139是具有粘性驱动铰链的铰接防护物的透视图;图140是具有环形整体弹簧的弹簧防护物的透视图;图141是具有箍类型整体弹簧的弹簧防护物的透视图;图142是示出了过度转动防护物的视图;图143是示出了处于准备状态中的凸轮作用保险装置的横截面图;图144是处于竖起状态中的图143的凸轮作用保险装置的横截面图;图145是处于点火状态中的图143的凸轮作用保险装置的横截面图;图146是处于安全状态中的图143的凸轮作用保险装置的横截面图;图147是另一个凸轮作用机构的横截面图;图148和149是翻动防护物的透视图;图150是处于未启动位置中的改良歧管弹簧的透视图;图151是处于未启动位置中的图150的歧管弹簧的另一个透视图;图152是处于启动位置中的图150的歧管弹簧的透视图;图153是处于未启动位置中 138 is a perspective view of a hinge shield integral spring; FIG. 139 is a viscous drive a perspective view of a hinge shield hinge; FIG. 140 is a perspective view of a ring-shaped integral spring spring shield; Figure 141 is a ferrule type a perspective view of a spring shield the entire spring; FIG. 142 is a diagram showing a view of the excessive rotation of the shield; FIG. 143 is a cross-sectional view illustrating a safety device in a cam action in the ready state; in FIG. 144 is a raised state a cross-sectional view of the cam acting safety device in FIG. 143; FIG. 145 is a cross-sectional view of the cam acting fuse ignition state in FIG. 143; FIG. 146 is in camming safety device safe state in FIG. 143 cross-sectional view; FIG. 147 is a cross sectional view of another cam action mechanism; 148 and 149 are perspective views of flip shield; FIG. 150 is a perspective view of an improved manifold spring unactuated position; 151 in FIG. another perspective view of the manifold of the spring 150 of FIG position does not start; FIG. 152 is a perspective view of the manifold of the starting position of the spring 150 of FIG.; FIG. 153 is in a deactivated position, 另一个改良歧管弹簧的透视图;图154是处于启动位置中的图153的歧管弹簧的透视图;图155是处于未启动位置中的另一个改良歧管弹簧的透视图;图156是处于启动位置中的图155的歧管弹簧的透视图;图157是示出了由按钮提供的填充孔的横截面图;图158是示出了填充之后处于适当位置中的阀组件的横截面图;图159是示出了在图158的阀组件的填充之后按钮窗的关闭的横截面图;图160是示出了图158的阀组件的关闭窗的横截面图;图161是示出了转动之前的阀、按钮阀孔以及按钮对齐的视图;图162是示出了转动之后的阀、按钮阀孔以及按钮对齐的视图; Perspective view of another modified manifold spring; Figure 154 is a perspective view of the manifold of the starting position of the spring 153; Figure 155 is a perspective view of another modified manifold spring unactuated position; FIG. 156 a perspective view of the manifold spring actuated position in FIG. 155; FIG. 157 is a diagram showing a cross-sectional view of the filling hole is provided by the button; FIG. 158 is a diagram showing a cross-section after the filling of a valve assembly in place of the ; Figure 159 is a diagram showing a cross-sectional view of the off button window after filling valve assembly of FIG. 158; FIG. 160 is a diagram showing a cross-sectional view of a closed window of the valve assembly of FIG. 158; FIG. 161 is a diagram illustrating before the rotary valve, a valve button and a button hole aligned view; FIG. 162 is a diagram showing the valve after the rotation of the button and the valve button orifice aligned view;

图163是示出了转动之后的阀、按钮阀孔以及按钮对齐的横截面图;图164是示出了注射之前的可见标记的容器的顶视图;图165是示出了注射之前的可见标记的图164的容器的侧视图;图166是示出了注射之后的缺乏标记的容器的顶视图;图167是示出了注射之后的缺乏标记的图166的容器的侧视图;图168是当空着的时候嵌套类型包装系统的等距视图;图169是当被填充的时候图168的嵌套类型包装系统的等距视图;图170是具有四个用于填充的装置的图168的嵌套类型包装系统的等距视图;图171是具有四个处于用于填充的高端位置中的装置的图169的嵌套类型包装系统的等距视图;图172是图168的嵌套类型包装系统的横截面图;图173是当被填充时图168的嵌套类型包装系统的顶视图;图174是双袋中图168的嵌套类型包装系统的横截面图;以及图175是当被装箱和打包时图168的嵌 FIG 163 is a diagram showing the valve after the rotation, a cross-sectional view of the button of the valve hole, and a button alignment; FIG. 164 is a diagram illustrating a top view of the container of visible markers before injection; FIG. 165 is a diagram illustrating a visible label before injection a side view of the container of FIG lack mark 166 after FIG. 167 is a diagram showing the injection;; side view of the container of FIG. 164; FIG lack labeled container 166 is a diagram showing a top view of the injection after the blank 168 when when an isometric view of the nested type of packaging system; FIG. 169 is a time when being filled isometric view of the nested type of packaging system of FIG. 168; FIG. 170 is inset 168 has a means for filling the four isometric view of a sleeve type packaging system; FIG. 171 is a view of the device in high-quality four positions for filling in the packaging system 169 of the nested type isometric view; FIG. FIG. 172 is a nested type of packaging system 168 the cross-sectional view; FIG. 173 is a top view when being filled with 168 of FIG nested type of packaging system; FIG. 174 is a cross-sectional view of a nested dual-type bag packaging system of FIG. 168; and FIG 175 is mounted when when packing boxes and embedded map 168 类型包装系统的横截面图。 Type cross-sectional view of the packaging system.

在所有图中,相似的附图应被理解为表示相似的零件、部件或结构。 In all the figures, like reference it is understood to refer to like parts, components or structures.

具体实施方式 Detailed ways

下面所描述的本发明的实施例可用作用于通过粘合剂连接的输液装置将预测定剂量的物质(诸如药品或药物)输送给使用者的方便的、片状装置。 Embodiments of the present invention described below may be used for delivery to a user-friendly by the infusion device connected to the dosing adhesive substance (such as a pharmaceutical or drug) predicted, sheet-like. 所述装置为整装的并且通过设在底表面上的粘合剂被连接于使用者的皮肤表面。 The device is self-contained and is attached to the skin surface of the user is provided on the bottom surface by an adhesive. 在由使用者适当地定位并启动之后,装置中容器表面上的放松贝式弹簧或其他盘形弹簧的压力可用于经由针歧管通过一个或多个患者微型针排空挠性容器的内容物。 After properly positioned by the user and start to put sombe spring means or other disc-shaped spring on the surface of the pressure vessel may be evacuated via a needle manifold by a flexible container or a plurality of contents patient microneedles . 之后容器中的物质通过打入皮肤中的微型针被输送到使用者的皮肤中。 After the container substance to be delivered to the user's skin by the microneedles into the skin. 应该理解的是,其中用不同类型的储能装置(所述储能装置可为机械的、电力和/或化学的)代替贝式弹簧或盘形弹簧的其他实施例也是可行的。 It should be appreciated that, where a different type of energy storage device (energy storage device may be a mechanical, electrical and / or chemical) instead of Belleville disk spring or other embodiments are possible.

如本领域中普通技术人员将明白的,存在多种执行文中所披露的片状注射或输液系统的方式。 As those skilled in the art will appreciate, there are a variety of ways disclosed herein performs the sheet-like injection or infusion system. 尽管将参考附图所描绘中的实施例和以下描述,但是不应认为所描述的实施例包含了本发明所包含的所有各种替换设计和实施例。 Although the embodiments depicted and described below in reference to the drawings, but should not be considered in the described embodiments includes all the various alternative designs according to the present invention and the embodiments included. 在每个所披露的实施例中,所述装置都被称作输液器;然而,所述装置也可在比输液装置通常执行的更快的推注速度下注射物质。 In each of the embodiments of the disclosed embodiment, the infusion device will be referred to; however, the device can also be injected substance at a faster speed than the bolus infusion apparatus normally performed. 例如,所述内容物可在短至数秒或长至数天的时间内被输送。 For example, the content may be delivered in a short or as long as several seconds to several days.

在图1到图4中所示的装置的第一实施例中,示出了按钮设计100,其中在一个多功能/步骤程序中执行装置的启动和激励。 In a first embodiment of the device shown in Figures 1 to 4, the design of the button 100 is shown, wherein the excitation means and starting execution in a multi-function / procedure step. 图1是处于未启动状态中的使用侧部按钮的片状注射器或输液系统的第一实施例的横截面图、图2是处于启动状态下的该实施例的横截面图、图3是图1中所示实施例的容器子配件的横截面图,以及图4是图1中所示实施例的贝式弹簧子配件的横截面图。 FIG 1 is a cross-sectional view of a first embodiment of a sheet-like syringe or an infusion system using a side button is not in the activated state, Figure 2 is a cross-sectional view of the embodiment in the activated state, FIG. 3 is a view cross-sectional view of the container subassembly of the embodiment in FIG. 1, FIG. 1 and FIG. 4 is a cross-sectional view of a Belleville subassembly embodiment shown in FIG.

图1到图4的装置包括按钮105、上部外壳110、下部外壳115、容器阀组件120、贝式弹簧130、弹簧保持盘135、歧管组件140、至少一个患者针141以及容器150。 Apparatus of Figures 1 to 4 includes a button 105, an upper housing 110, lower housing 115, the container shutter assembly 120, a Belleville spring 130, the spring holding plate 135, the manifold assembly 140, the at least one patient needle 141 and a container 150. 所述装置还可包括用于保护针141并且在使用之前去除的针防护物111。 The apparatus further comprises a needle shield 111 is removed prior to use and 141 for protecting the needle. 所述按钮包括至少一个倾斜元件106,所述倾斜元件106具有用于当按钮105在启动期间移动时与盘135的外径136相接合的倾斜表面107。 The button element 106 comprises at least one inclined, the inclination member 106 having a button 105 used when moving during startup and the outer diameter 136 of 135 engages inclined surface 107. 当如图2中所示的向内推动按钮105时,倾斜表面107使得盘135的至少一侧向上位移,这导致所述盘的内径137向下位移。 Button is pushed inwardly as shown in FIG. 2 as 105, so that the inclined surface 107 of plate 135 upward displacement of at least one side, which leads to the inner diameter of the disc 137 downward displacement. 在这种情况下,盘135的内径137从贝式弹簧130的中心被拉起,放松弹簧130之后向容器150的挠性元件151施力,将内容物压靠在容器150的刚性元件152上。 In this case, the inner diameter 137 of the disc 135 is pulled up from the center of the Belleville spring 130 to relax the spring 130 then urging the flexible element 150 into the container 151, the contents of the element 152 is pressed against the rigid container 150 . 如图4中所示的,容器150包括邻近于贝式弹簧130的挠性元件151和刚性元件152。 Shown in Figure 4, the container 150 comprises a flexible member adjacent to the Belleville spring 130 of the rigid member 151 and 152. 贝式弹簧130通过与盘135的突出内径137干涉配合被保持得远离挠性元件151。 Belleville projecting inner diameter 130 of the disk 135 by an interference fit 137 be kept away from the flexible member 151.

按钮105还包括用于与阀组件120的阀元件121相接触的表面108以便于在容器150和患者针141之间形成流动路径。 Button 105 further includes a surface in contact with the valve element 121 of the valve assembly 120 so as to form a flow path 108 between the container 150 and the needle 141 patients. 如图3中所示的,当阀元件121被向内推动时,推挽类型阀组件120在容器出口153和外圆周流体路径154之间形成流动路径。 As shown in FIG. 3, when the valve member 121 is pushed inward, a push-pull type valve assembly 120 is formed a flow path between the container 153 and the outer circumference of the outlet fluid path 154. 当被向内推动时,增大的阀元件端部122从袋123处位移,允许来自于容器150的流体围绕阀元件121的减小的直径,并且朝向歧管组件140进入到流体路径154,以及其中的针141。 When pushed inwardly, the valve element 122 increases from an end portion of the displacement of the bag 123, allowing fluid from the container 150 around the reduced diameter of the valve element 121 toward the manifold assembly 140 into the fluid path 154, and wherein the needle 141. 流体路径154被设在可用于推动针歧管140的流体路径臂155中。 Fluid path 154 is provided in the fluid path can be used to push the needle arm 140 of the manifold 155.

当按钮105被向内推动时,支撑元件109在歧管组件140的肩部142之外移动,从而使得歧管组件140朝向患者皮肤表面(未示出)被向下驱动。 When the button 105 is pushed inwardly, the support member 109 is moved out of the manifold assembly of the shoulder portion 142,140, ​​so that the patient's skin surface 140 toward the manifold assembly (not shown) is driven downwardly. 所述歧管组件可由多种装置(诸如盘簧)驱动,或者通过外径流体通路臂155的弯曲特性被驱动。 The manifold assembly may be a variety of devices (such as a coil spring) drive, or be driven by the characteristics of the outer diameter of the curved arm 155 of the fluid passage. 流体通路臂155可被构成得当被支撑元件109释放时压迫歧管组件140。 Fluid passage arm 155 may be configured to be properly supported when compression member 109 is released the manifold assembly 140.

在图1到图4所示的实施例中,当按钮105被推动时,以有序和/或同时的方式实现所述功能。 In the embodiment illustrated in FIG 1 to FIG 4, when the button 105 is pushed in an orderly and / or simultaneous manner to achieve the function. 首先,按钮105的移动打开至少一个允许容器150与患者针141之间的流体连通的阀组件120。 First, the movement of button 105 to open the at least one valve assembly to allow fluid communication between the container 150 in communication with the needle 120 of 141 patients. 第二,按钮105的移动移去了弹簧保持盘135,放松贝式弹簧130,第三,按钮105的移动从患者针歧管140上移除了支撑元件109,允许歧管140像被诸如流体通路臂155或歧管弹簧(未示出)等装置推压那样前进。 Second, the move button 105 is removed the spring holding plate 135, a spring 130 put sombe, third, movable button 105 is removed from the support member 109 on the needle manifold patient tube 140, manifold 140 allows fluid such as is as the forward passage or manifold spring arm 155 (not shown) pressing apparatus.

具体地,按钮105包括一系列倾斜部分107,所述倾斜部分107在按钮105滑移时与弹簧保持盘135相接合,并且放松贝式弹簧130从而为容器150的内容物加压。 In particular, the button 105 includes a series of inclined portion 107, the inclined plate portion 107 remains engaged with spring 135 when the sliding button 105, spring 130 and thereby release sombe pressurize the contents of the container 150. 按钮105还与推动阀120相接合,启动当前加压的容器150与歧管组件140之间的流动。 Button 105 is also engaged with the push valve 120, a current starts to flow between the pressurized vessel 150 with the manifold assembly 140. 按钮105还将一个或多个支撑元件109从患者针歧管组件140上移除或移开,使得歧管140由诸如流体通路臂155或一个或多个驱动弹簧(未示出)等驱动装置驱动,并且固定患者针141。 Button 105 will also be one or more support elements 109 removed or removed from the patient needle manifold assembly 140, the manifold 140 so that the arm 155, such as a fluid passage or one or more drive springs (not shown) is driven by means driven, and the fixing pin 141 patients.

图1中所示的实施例的推挽阀组件120被构成得用于在由按钮105推入到打开位置中之前限制容器腔(即,当设置在元件151和152或容器150之间时)与患者针歧管140之间的流动,并且推挽阀组件120可由任意数量的阀组件120、222、226和228构成,如下面更详细地描述的。 Push-pull valve assembly of the embodiment shown in FIG. 1 120 is configured to be used to limit the chamber before the container is pushed by the button 105 into the open position (i.e., when the element is disposed between the container 150 or 151 and 152) flow between patient tube 140 and the needle manifold, and pull the valve assembly 120 may be any number of valve assemblies 120,222,226 and 228 constitute, as described in more detail below.

在图5和图6中示出了推动阀组件222的第一实施例。 Shown in FIG. 5 and FIG. 6 a first embodiment of a push valve assembly 222. 图5是处于关闭位置中的阀组件122的横截面图,而图6是处于打开位置中的图5的阀组件的横截面图。 FIG 5 is a cross-sectional view of the valve assembly in a closed position 122, and FIG. 6 is a cross-sectional view of the valve assembly in the open position of FIG. 阀组件222包括可滑动地接合在与容器150流体连通的橡胶止动器224中的塑料按钮223。 The valve assembly 222 comprises a slidably engaging the fluid container 150 in communication with the rubber stopper 224 of the plastic button 223. 阀组件222具有初始状态和启动状态,并且包括具有远端径向突出毛刺或肋225组的大直径远端和具有近端棘爪226组的减小直径近端。 The valve assembly 222 has an initial state and an active state, and a large diameter distal end comprising a distal end having a radially projecting burrs or ribs 225 having a set and a reduced diameter proximal end of the pawl proximal end 226 of the group. 在初始状态中,阀222远端肋225用于防止微生物进入流体路径227中,并且近端棘爪形成密封以便于将药品安全地收集在容器150中。 In the initial state, the distal end of the rib 225 valve 222 for preventing microorganisms from entering the fluid path 227, and the proximal end of the pawl is formed so as to seal the drug safely collected in container 150. 在长时间防止流体从容器的内部流失时以及在相同时间内防止药品从容器外部被污染时,肋225组和棘爪226组两者都执行关键的任务。 Upon prolonged prevent loss of fluid from the interior of the container and to prevent contamination of the drug from outside the container at the same time, both sets of ribs 225 and the pawl 226 groups perform critical tasks.

在使用中,钮223将最终通过按钮105的移动被推入到启动状态下并且棘爪组将从与橡胶止动器124相接合处前进,这允许药品从容器150中流出,越过棘爪226并且进入阀流体路径154。 In use, the button 223 will move button 105 is eventually pushed through into the activated state and the pawl 124 and proceeds from the group of the engagement rubber stopper, which allows the drug flows from the container 150, the pawl 226 beyond the the fluid path and inlet valve 154. 同时,远端肋225组也被自然推入,并且肋225本身的位置移动到这样一个位置,使得它们直接引导容器150中的流体、通过阀流体路径227、以及从流体路径154向下到患者针歧管(未示出)。 Meanwhile, the distal rib 225 is naturally also pushed into the group, and the rib 225 to position itself in a position such that they are guided directly in the fluid containers 150, 227, 154, and downward from the fluid path through the valve fluid path to the patient needle manifold (not shown).

在图5中所示的位置中,塑料按钮223包括牢固地设置在橡胶止动器124中的具有棘爪226的减小直径近端,并且防止任何流体溢出容器150。 In the position shown in FIG. 5, comprises a plastic button 223 fixedly disposed in the rubber stopper 124 having a reduced diameter of the proximal detent 226, and 150 to prevent any fluid from escaping the container. 由于按钮105使得塑料按钮223接合在橡胶止动器224中并且在橡胶止动器224中位移,因此在近端处形成开口,所述开口允许与容器150的流体连通,如图6中的箭头所示的。 Since the button 105 so that the plastic button 223 engages the rubber stopper 224 and the displacement of the rubber stopper 224, thus forming an opening at the proximal end, said opening allowing fluid communication with the container 150, the arrow 6 in FIG. It is shown. 阀组件222也可被包含在容器子配件150中,以使得可由容器子配件150在容器内容物与患者微型针141之间提供连续的流体路径154。 The valve assembly 222 may also be contained in the container subassembly 150 to subassembly 150 such that the container may provide a continuous fluid path between the container 154 and the contents of the microneedle 141 patients.

在图7中示出了阀组件242的第二实施例。 In FIG. 7 shows a second embodiment of the valve assembly 242. 图7是处于打开位置中的第二实施例的横截面图。 FIG. 7 is a cross-sectional view of a second embodiment in an open position. 阀组件242包括塑料按钮247,并且被构成得用作拉阀。 The valve assembly 242 includes a plastic button 247, and is configured to be used as a pull valve. 如图7中所示的,当被向前推动时,塑料按钮247与容器150开口配对地接合并且阻止与容器150的流体连通。 , When pushed forward, the plastic button 247 engages the mating opening of the container 150 as shown in FIG. 7 and prevent fluid communication with the container 150. 当从容器150开口上被拉起时,所产生的间隙允许沿按钮247的圆锥面的流体连通并且朝向患者针歧管(未示出)流入到流体路径154中。 When 150 is pulled from the opening of the container, a gap allowing the resulting fluid along the conical surface of the button 247 and the communication towards the patient needle manifold (not shown) flows into the fluid path 154.

阀组件242具有初始状态和启动状态,并且包括具有远棘爪243组的大直径远端、圆锥部分244以及减小直径近端245。 The valve assembly 242 has an initial state and an active state, and includes a distal detent 243 having a group of large diameter of the distal, conical portion 244 and a reduced diameter proximal end 245. 在初始状态中,阀242远棘爪243用于阻止微生物进入流体路径246中,并且圆锥部分244和近端245形成密封以便于将药品安全地收集在容器150中。 In the initial state, the pawl 243 away valve 242 for preventing microorganisms from entering the fluid path 246, and the conical portion 244 and a proximal seal 245 is formed so as to be safely collected in the drug container 150. 棘爪243、圆锥部分244以及减小直径近端245中的每个都长时间防止流体从容器150的内部流失以及同样长时间防止药品从容器150外部被污染。 Pawl 243, and each of the conical portion 244 of reduced diameter proximal end 245 are time preventing loss of fluid from the interior of the container 150 and the same time prevent the medicine from the outer container 150 from being contaminated.

在使用中,钮247将最终通过替换型式的按钮(未示出)的移动被推入到启动状态下并且圆锥部分244和减小直径近端245将从与容器150开口的接合处前进,这允许药品从容器150中流出,越过减小直径近端245并且进入阀流体路径246。 In use, the button 247 will eventually be replaced by type button (not shown) is moved to the next start-up state is pushed into the conical section 244 and a reduced diameter proximal end 245 and proceeds with the junction 150 from the opening of the container, which allowing the drug to flow out of the container 150, over the reduced diameter proximal end 245 and inlet valve 246 in fluid path. 同时,远棘爪243组移动到这样一个位置,使得它们直接从容器150中引导流体、通过阀流体路径246、以及从流体路径154向下到患者针(未示出)。 Meanwhile, the far pawl 243 moves to a position set such that they direct fluid from the container 150, the fluid path through the valve 246, and (not shown) from the fluid path to the patient needle 154 downward.

在图8中示出了阀组件262的第三实施例。 In FIG. 8 shows the valve assembly 262 of the third embodiment. 图8是处于打开位置中的第四阀组件实施例的横截面图,并且阀组件262包括塑料元件263,被构成得用作推动阀或拉阀。 FIG 8 is a cross-sectional view of an embodiment of a fourth open position the valve assembly and the valve assembly 262 includes a plastic element 263 is configured to be used as a push or pull the valve the valve. 如图8中所示的,当被向外拉动时,塑料元件263堵塞容器开口并且阻止与容器150的流体连通。 As shown in FIG. 8, when pulled outward, the plastic member 263 and to prevent clogging of the container opening in fluid communication with the container 150. 当塑料元件被向前推动时,塑料元件与开口对齐并且允许容器150与患者针歧管140(未示出)之间的流体连通。 When the plastic element is pushed forward, the plastic member is aligned with the opening 150 and allows the container to the patient needle manifold 140 (not shown) in fluid communication between the.

阀组件262具有初始状态和启动状态,并且包括具有远棘爪264组的远端、以及增大直径近端265。 The valve assembly 262 has an initial state and an active state, and includes a distal detent 264 having distal end of the group, and increasing the diameter of the proximal 265. 在初始状态中,阀262远棘爪264用于阻止微生物进入流体路径267中,并且增大直径近端265与塞子插入元件270的端部266形成密封以便于将药品安全地收集在容器150中。 In the initial state, the pawl 264 away valve 262 for preventing microorganisms from entering the fluid path 267, and 265 increase the diameter of the proximal end of the stopper member 270 is inserted into the end seal portion 266 is formed so as to be safely collected in the drug container 150 . 棘爪264、和增大直径近端265中的每个都长时间防止流体从容器150的内部流失以及同样长时间防止药品从容器150外部被污染。 Pawls 264, 265 and increase the diameter of the proximal end of each time preventing loss of fluid from the interior of the container 150 and the same time preventing contamination of the drug from the exterior of the container 150.

在使用中,元件263将最终通过按钮105的移动被推入到启动状态下并且增大直径近端265将从与塞子插入元件270的端部266的接合处前进,这允许药品从容器150中流出,越过增大直径近端265并且进入阀流体路径267。 In use, member 263 is pushed into the final start-up state 265 and increasing the diameter of the proximal engaging member 270 at an end portion of the plug 266 is inserted from forward movement by the button 105, which allows the drug from the container 150 flows, is increased over the diameter of the proximal valve 265 and into the fluid path 267. 同时,远棘爪264组移动到这样一个位置,使得它们直接从容器150中引导流体、通过阀流体路径267、以及通过开口268和269从流体路径154向下到患者针(未示出)。 Meanwhile, the far pawl 264 moves to a position set such that they direct fluid from the container 150, the fluid path through the valve 267, and through the openings 268 and 269 (not shown) from the fluid path to the patient needle 154 downward.

在如图9到11中所示的装置的第二实施例中,示出了按钮设计280,其中也在一个多功能/步骤程序中执行装置的启动,但是针歧管和容器组件围绕设置在与针歧管相对的点处的铰链转动。 In the second embodiment of the apparatus 9 to 11 shown in the figure, the design button 280 is shown, which is also a multi-function activation device / step program execution, but the needle manifold and container assembly disposed around the hinged at a point opposite the manifold with the needle. 图9是处于未启动状态中的使用顶部按钮表面的片状注射器或输液系统的第二实施例的横截面图、图10是处于启动状态下的第二实施例的横截面图以及图11是图9和图10中所示实施例的容器子配件的顶视图。 FIG 9 is a cross-sectional view of a second embodiment of an infusion system or the like injector of the top surface of the button is not activated state of use, Figure 10 is a cross-sectional view of a second embodiment in FIG. 11 is a start state, and 9 subassembly and a top view of the container embodiment shown in FIG. 10. 如同第一实施例一样,可使用一个步骤启动装置。 As with the first embodiment, the step of using a starting device.

图9到图11的装置包括上部外壳281、下部外壳282、贝式弹簧283、弹簧保持盘284、歧管组件285、至少一个患者针286以及具有挠性元件289和刚性元件288的容器287。 Apparatus of Figures 9 to 11 comprises an upper housing 281, lower housing 282, a Belleville 283, the spring holding plate 284, the manifold assembly 285, the at least one patient needle 286 and a container 289 having a flexible member 288 and a rigid element 287. 在图9到图11所示的实施例中,贝式弹簧283由盘284保持并且随后放松,并且基本与图1的弹簧130、盘135和容器150相似但是在倒转位置中压缩容器287,以使得容器287的刚性元件288被构成得在第一端包含歧管组件285,以及在第二端包含铰链机构291。 In the embodiment shown in FIG. 11 to FIG. 9, the Belleville disk 283 by the holder 284 and then relaxed, and substantially the spring 130 of FIG. 1, the disk 135 is similar to container 150 and container 287 in a compressed but in an inverted position, to such that the rigid element 288 of the container 287 is configured to be at a first end 285 comprises a manifold assembly, and a second end 291 comprising a hinge mechanism.

在图9到图11的实施例中,铰接的容器287通过诸如钮(未示出)等放松装置被放松,从而放松贝式弹簧283之后对容器287的挠性元件289施力,将内容物压靠在容器287的刚性元件288上。 In the embodiment of FIG After 9 to 11, the container 287, such as by hinge button (not shown) or the like relaxing means is relaxed, so that the discharge sombe spring 283 pairs of flexible element 289 urging the container 287, the contents were rigid element 287 is pressed against the vessel 288. 如图10中所示的,当被放松时,弹簧290朝向患者的皮肤表面(未示出)远离盘284向下驱动歧管组件285和容器287,放松贝式弹簧283并且为容器内容物加压。 As shown in FIG. 10, when relaxed, the spring 290 towards the skin surface of the patient (not shown) downwardly away from the disk drive 284 of the manifold assembly 285 and the container 287, spring 283 and the discharge sombe container contents plus pressure. 任何数量的阀组件都可用于形成容器287和歧管285之间的流体路径。 Any number of valve assemblies may be used in a fluid path between the container 287 and the manifold 285.

在图9到图11中所示的实施例中,在放松的情况下,贝式弹簧283、歧管组件285、患者针286以及容器287转动到启动和在用位置中,以有序和/或同时的方式实现所述三种功能。 In the embodiment illustrated in FIG. 9 to FIG. 11, in the case of relaxation, Belleville 283, the manifold assembly 285, patient needle 286 and a container 287 and turned to the starting position with in an orderly and / or manner of the three functions simultaneously. 第一和第二,所述启动允许弹簧290转动容器287和歧管285,这移除了弹簧保持盘284,放松贝式弹簧283并且开始从容器287中的流动。 A first and a second, allowing the spring 290 to start the rotation of the container 287 and the manifold 285, which removed the spring holding plate 284, spring 283 and the discharge sombe begins to flow from the container 287. 第三,所述启动还允许歧管285在由歧管弹簧290推压时前进并安放针286。 Third, the manifold 285 starts further allows the needle 286 forward and placed by the manifold when the spring 290 is pressed.

在图12到24中示出了第二实施例的另一种型式。 In FIGS. 12 through 24 illustrate another version of the second embodiment. 在图12到24中所示的第二实施例的型式中,示出了按钮设计300,其中在一个多功能/步骤程序中执行装置的启动。 In the version of the second embodiment shown in FIG. 12 through 24, the design of the button 300 is shown, wherein the actuating means is performed in a multi-function / procedure step. 图12和13是使用顶部按钮表面以允许使用者向下压上部外壳305并且将装置转动到启动和在用位置中的片状注射器或输液系统的第二实施例的分解图。 12 and FIG. 13 is a top surface of the button to allow the user presses down the upper housing 305 and the rotation means to the exploded view of a second embodiment of a sheet-like syringe or an infusion system and start using position. 图14到17是在启动之前图12的片状注射器或输液系统的第二实施例的视图。 FIGS 14 to 17 are views of the second embodiment in FIG. 12 before starting sheet-like syringe or an infusion system. 图18到21是在启动之后图12的片状注射器或输液系统的第二实施例的视图。 18 21 is a view of a second embodiment of a sheet after activation to FIGS syringe or an infusion system 12 of FIG. 图22(a)到22(e)是图12的片状注射器或输液系统的容器子配件的多个图。 FIG. 22 (a) to 22 (e) is a view of a container subassembly plurality of sheet-like syringe or an infusion system 12 of FIG. 图23和24分别是处于关闭和打开位置中的图12的片状注射器或输液系统的容器子配件和阀子配件的视图。 23 and 24 are closed and opened position of the sheet-like syringe or an infusion system of FIG. 12 parts of the container and the sub-view in a valve subassembly.

如图12和13中所示的,本发明的第二实施例包括具有上部外壳305、贝式弹簧保持盘310、至少一个贝式弹簧315、容器膜320、容器子配件325、至少一个患者微型针340以及下部外壳350的输液装置300。 The second embodiment of the present invention as shown in Figures 12 and 13 comprises a housing 305 having an upper portion, a Belleville disc holder 310, 315 at least one Belleville, film 320 of the container, the container subassembly 325, at least one micro patient an infusion needle 340 and a lower casing 300 350. 容器子配件325还包括阀芯326和阀座328,以及枢轴机构327(诸如销)。 Container subassembly 325 further includes a valve body 326 and a valve seat 328, and a pivot mechanism 327 (such as a pin). 枢轴机构327由设置在下部外壳上的至少一个销开口329接收,允许上部外壳305、贝式弹簧保持盘310、贝式弹簧315、容器膜320、容器子配件325、以及患者微型针340转动到启动和在用位置中。 By a pivot mechanism 327 disposed on the lower housing at least one pin receiving opening 329, allowing the upper housing 305, the retaining disc 310 Belleville, Belleville 315, film 320 of the container, the container subassembly 325, and the rotation of the patient microneedles 340 and with the start position. 使用者可压制上部外壳305以便于将贝式弹簧315从盘310上放松,之后贝式弹簧315向挠性元件320施力,将内容物压制在容器子配件325上。 The user can press the upper housing 305 from the disc 310 so as to relax the Belleville 315, 315 after the Belleville biased flexible elements 320, and the contents were compressed on a container subassembly 325. 使用者的操作还朝向患者的皮肤表面(未示出)并远离盘310向下驱动患者微型针340。 User operations further towards the skin surface of the patient (not shown) downwardly and away from the disk drive 310 microneedles 340 patients. 同时,使用者可启动下面将参照图23和24更详细地描述的推动或拉动类型的阀子配件(即,阀芯326和阀座328),从而在容器和患者微型针340之间形成流体路径。 Meanwhile, the user may start below with reference to FIGS. 23 and 24 to push or pull type described in more detail in a valve subassembly (i.e., the valve body 326 and the valve seat 328), thereby forming a fluid between the container and the patient microneedles 340 path.

图14到17是在启动之前图12的装置300的视图。 FIGS 14 to 17 are views of the device 300 of FIG. 12 before starting. 图14是示出了在围绕下部外壳350转动到启动和在用位置中之前的转动部件(即,上部外壳305、贝式弹簧保持盘310、贝式弹簧315、容器膜320、容器子配件325、以及患者微型针340)的等距视图。 14 is a diagram illustrating a rotation about the lower housing 350 to the rotatable member prior to start-up and with position (i.e., the upper housing 305, a Belleville spring holding plate 310, a Belleville spring 315, the container film 320, the container subassembly 325 and an isometric view of the patient microneedles 340). 图15是示出了在启动和放置于在用位置中之前转动部件的定位的横截面图。 FIG 15 is a cross-sectional view illustrating a start to the rotation and the positioning member is placed before the position in the. 图16是示出了在启动和放置于在用位置中之前转动部件与下部外壳350的分离的侧视图。 FIG 16 is a side view showing start and placed in the lower housing member is rotated until the position separated at 350.

图18到21是在启动之后图12的装置300的视图。 21 is a view of the apparatus of FIG. 18 to 300 of FIG. 12 after activation. 图18是示出了围绕下部外壳350转动到启动和在用位置中之后的转动部件(即,上部外壳305、贝式弹簧保持盘310、贝式弹簧315、容器膜320、容器子配件325、以及患者微型针340)的等距视图。 FIG 18 is a diagram showing the rotating member after surrounding the lower housing 350 is rotated to start and with position (i.e., the upper housing 305, a Belleville spring holding plate 310, a Belleville spring 315, the container film 320, the container subassembly 325, and an isometric view of the patient microneedles 340). 图19是示出了在启动和放置于在用位置中之后转动部件的定位的横截面图。 19 is a diagram illustrating a cross-sectional view in starting and rotation of the positioning member placed in a position after. 图20是示出了在启动和放置于在用位置中之后转动部件与下部外壳350的接合的侧视图。 FIG 20 is a side view showing start-up and placed in the lower housing member is rotated after the engagement with the position 350.

图22(a)到22(e)是图12的装置300的容器子配件的多个图。 FIG. 22 (a) to 22 (e) is a view of the container a plurality of sub-assemblies 12 of the device 300 of FIG. 图22(a)是图12的装置300的容器子配件的顶视图。 FIG. 22 (a) is a top view of the container subassembly of the device 300 of FIG. 12. 图22(b)是第一侧视图、图22(c)是第二侧视图、以及图22(d)是图12的装置300的容器子配件的第三侧视图。 FIG. 22 (b) is a first side view, FIG. 22 (c) is a second side view, and FIG. 22 (d) is a side view of a third container device subassembly 300 of FIG. 12. 图22(e)是图12的装置300的容器子配件的底视图。 FIG. 22 (e) is a container subassembly of the device 300 of FIG. 12 is a bottom view.

图23和24分别是处于关闭和打开位置中的图12的装置300的容器子配件325和阀子配件(即,阀芯326和阀座328)的视图。 23 and 24 are closed and open positions means 12 in the container subassembly 300 and the valve subassembly 325 (i.e., the valve body 326 and the valve seat 328) in view. 具体地,阀芯326包括多个凸起的棘爪332,当处于图23中所示的关闭位置中时,凸起棘爪332阻断容器路径330与患者针路径331之间的流体路径333。 In particular, the valve body 326 includes a plurality of detent protrusions 332, when in the closed position shown in FIG. 23, the fluid path between the projections 331 of the pawl 332 and path 330 to block the container patient needle path 333 . 当阀芯326被向内推入到阀座328中时,凸起棘爪移动得离开流体路径,允许容器的内容物从容器路径330经由路径333前进到针路径331。 When the spool 326 is pushed inwardly into the valve seat 328, the ratchet protrusion moves away from the fluid path, the contents of the container to allow the container path 330 via path 333 proceeds from 331 to the needle path.

与图1中的本发明第一实施例100一样,本发明的第三实施例300也可被构成得提供了片状的、可佩带的、整装物质输液装置,所述装置可用于向患者输送多种药物。 Embodiment 100 of the present invention in FIG. 1 as a first embodiment, the third embodiment 300 of the present invention may also be configured to be provided a sheet-like, wearable, self-contained substance infusion device, the device may be used to a patient transport a variety of drugs. 装置300在使用之前和使用期间提供了隐蔽式患者针340,并且所述装置300可通过设在下部外壳350上的粘合表面(未示出)被固定于患者。 Before using the apparatus 300 provides a concealed needle 340 and the patient during use, and the apparatus 300 may be provided by an adhesive on the lower surface of the housing 350 (not shown) is secured to the patient. 如上所述的,通过移除或移开弹簧保持盘310可实现容器内容物(即,包含在容器膜320与容器子配件325之间的内容物)的加压,以便于为内容物加压,并且所述装置可通过施加于上部外壳305的顶部推动表面的合理力再被启动以便于安放患者针340。 As described above, the disc 310 may be implemented to maintain the contents of the container (i.e., film 320 contained in the container and the container contents between the subassembly 325) is pressurized by removing or removing springs, so as to pressurize the contents and the apparatus may be applied to the top by the upper housing 305 of reasonable force pushing surface is then activated to place the patient in the needle 340. 在这种情况下,装置300便于自注射并且减少或消除使用者注射技术上的不同。 In this case, it means 300 facilitate self-injection and reduces or eliminates the injection of different technical users.

在图25到27中所示的装置的第三实施例中,示出了按钮设计400,其中也在一个多功能/步骤程序中执行装置的启动和激励。 In a third embodiment of the device shown in FIGS. 25-27, the design of the button 400 is shown, which is also a versatile starting and energizing means / step program execution. 图25是片状注射器或输液系统的第三实施例的分解图。 FIG 25 is an exploded view of a third embodiment of a sheet-like syringe or an infusion system. 图26和27是在启动之前和之后图25的片状注射器或输液系统的第四实施例的横截面图。 26 and 27 are started and before a cross-sectional view of a fourth embodiment of a sheet 25 after the syringe or an infusion system.

在图25到27中所示的本发明的第三实施例中,输液装置400包括按钮405、容器子配件410、贝式弹簧保持柄430、至少一个贝式弹簧435、容器膜440、容器膜表面442、T形销445、至少一个患者微型针460以及下部外壳470。 In a third embodiment of the present invention shown in FIGS. 25-27, the infusion device 400 includes a button 405, the container subassembly 410, Belleville retention knob 430, 435 at least one Belleville, 440, the container film container film surface 442, T-shaped pins 445, 460 at least one patient microneedle 470 and a lower housing. T形销445还包括阀组件450,并且下部外壳470可包括粘合表面475。 T-shaped pin 445 further includes a valve assembly 450, the housing 470 and the lower surface 475 may include an adhesive.

如图25到27中所示的,本发明的实施例400可被构成得提供了片状的、可佩带的、整装物质输液装置,所述装置可用于向患者输送多种药物。 , Embodiments of the present invention shown in FIG 25-27 400 may be configured to be provided a sheet-like, wearable, self-contained substance infusion device, the device may be used to deliver multiple drugs to a patient. 装置400在使用之前和使用期间提供了隐蔽式患者针460,并且所述装置400可通过粘合表面475被固定于患者。 Before using the apparatus 400 provides a concealed patient needle 460 and during use, the apparatus 400 and 475 may be secured to the patient by an adhesive surface. 通过移除或移开弹簧保持柄430可实现容器内容物(即,装在容器膜440与容器膜表面442之间的内容物)的加压,从而放松贝式弹簧435以便于为容器内容物加压。 Or removal by removing the handle holding spring 430 the container contents can be achieved (i.e., contained in a container film 440 and the container contents between the film surface 442) pressurized so that the discharge sombe spring 435 so that the contents of the container pressure. 之后所述装置可通过朝向装置向内滑动接合按钮405而被再启动。 After the device button 405 may be slidably engaged by the inwardly toward the device is restarted. 当按钮405前进时,按钮405中的阶状开口406放松T形销445的直角元件446,从而放松T形销445,并且当被设置在T形销445中的环形开口410中的盘簧408向前驱动时允许患者针460下降。 When the button 405 forward, the button 405 a stepped opening 406 to relax the T-shaped pin right angle element 445 is 446, thus relaxing the T-shaped pin 445, and when the ring is disposed in a T-shaped pin 445 410 coil spring 408 opening allowing the patient to fall when the needle 460 is driven forward. 在这种情况下,患者微型针460就位。 In this case, the patient microneedles 460 in place. 当T形销445下降时,阀450的开451与流体沟槽452对齐,所述流体沟槽452与容器流体连通,从而在容器内容物与患者针460之间形成流体路径。 When the T-shaped pin 445 drops, valve 450 opening 451 is aligned with the fluid channel 452, the fluid channel 452 in fluid communication with the container, thereby forming a fluid path between the container contents and patient needle 460.

图26和27是在启动之前和之后的装置400的横截面图。 26 and FIG. 27 is a cross-sectional view before starting and after the apparatus 400. 在图26(为了简单起见没有示出贝式弹簧保持柄430、下部外壳470和粘合表面475)中,T形销445由阶状开口406支撑,压缩弹簧408。 26 (not shown for simplicity Belleville holding handle 430, a lower adhesive surface 475 and the housing 470), T-shaped pin 445 is supported by the stepped opening 406, a compression spring 408. 在弹簧保持柄430已被移除以放松贝式弹簧435之后,装置400可被放置在皮肤表面(未示出)上的位置中。 After the spring holding the shank 430 has been removed to put sombe spring 435, means 400 may be placed on the skin surface (not shown) in the upper position. 当按钮405被推动时,阶状开口406放松T形销445的直角元件446,从而放松T形销445,并且允许患者针460下降,如图27中所示的。 When the button 405 is pushed, the stepped opening 406 at right angles to the T-shaped element to relax 445 pin 446, thus relaxing the T-shaped pin 445, pin 460 and allow the patient to drop, as shown in FIG. 27. 在图27中,患者微型针460就位并且阀450的开口451与流体沟槽452对齐,所述流体沟槽452与容器流体连通,从而在容器内容物与患者针460之间形成流体路径。 In Figure 27, the patient microneedles 460 in position 450 and 451 of the valve opening 452 is aligned with the fluid channel, the fluid channel 452 in fluid communication with the container, thereby forming a fluid path between the container contents and patient needle 460.

在图28到31中所示的装置的第四实施例中,示出了按钮设计500,其中也在一个多功能/步骤程序中执行装置的启动和激励。 In a fourth embodiment of the device shown in FIG. 28 to 31, the design of the button 500 is shown, which is also a versatile starting and energizing means / step program execution. 图28到31是片状注射器或输液系统的第四实施例的顶视图。 FIGS 28 to 31 are top views of a fourth embodiment of the sheet-like syringe or an infusion system. 图32和33分别是处于关闭和打开位置中的图28的片状注射器或输液系统的阀子配件的局部横截面图。 32 and 33 are partial cross-sectional view in the closed and open positions of the valve subassembly of FIG like injector 28 or infusion system.

如图28到31中所示的,所述装置包括按钮505、弹簧510、歧管臂520、激励环530、弹出开启工具540、容器550、阀组件560以及阀接合棘爪570。 As shown in FIG. 28 to 31, the apparatus comprises a button 505, a spring 510, the manifold arm 520, energizing ring 530, opening pop-up tool 540, the container 550, the valve assembly 560 and the valve 570 engages the pawl. 弹簧510在相对侧处分别具有第一和第二调整片521和522,并且被固定在装置500中以便于当第二调整片升高时通过第一调整片施加向下力,以及当第一调整片升高时通过第二调整片施加向下力,所述力被施加在各个调整片下面的环530部件(即,511、513、514)或歧管部件(即,520)上。 Springs 510 each having opposite first and second side tabs 521 and 522 and is fixed in the device 500 so that when the second raised tab downward force exerted by the first tab, and when the first applying a downward force upon the second raised tab by tab, the force is applied in the ring member 530 below each tab (i.e., 511,513,514) or a manifold member (i.e., 520) on. 贝式弹簧(未示出)也被设在容器550之下。 Belleville (not shown) is also provided under the container 550. 还提供了盖(未示出)以覆盖上部部件,但是这里为了便于描述而省略了所述盖。 It is also provided a cover (not shown) so as to cover the upper part, but here omitted for convenience of description the cover. 图28的装置被构成得用于在加载位置(如图28中所示的)、启动或点火位置(如图29和30中所示的)、以及图31中所示的缩回位置之间操作。 FIG apparatus 28 is configured to be used to start the ignition position or the loading position (as shown in FIG. 28) between (as shown in FIG. 29 and 30), and a retracted position shown in FIG. 31 operating.

具体地,如图28中所示的,在基本如上所述的将片状装置500施加在皮肤表面(未示出)上之后,施加于按钮505上的力将使得按钮505枢转,或关于点506弯曲。 Specifically, as shown in FIG. 28, when the sheet member 500 is applied substantially as described above, after the skin surface (not shown), the force on the button 505 such that button 505 will pivot, or on 506-point bending. 当按钮505枢转时,按钮505的线性元件508在第一棘爪509处接触激励环530,如箭头A所示的那样转动环530。 When the pivot button 505, the button 505 of the linear member 508 contacts the first pawl 530 energizing ring 509, the ring 530 is rotated as shown by an arrow A in. 当环530转动时,弹簧510从连杆511处下降到沟槽512中并且向下驱动歧管和歧管臂520。 When the ring 530 is rotated, the spring 510 from the link 511 drops into the groove 512 and driven down the manifold 520 and the manifold arm. 另外,当环530转动时,弹出开启工具540通过倾斜部分582(见图35和36)被接合在环530上,环530用于使得弹出开启工具540与贝式弹簧相分离,放松贝式弹簧从而为容器550内容物加压。 Further, when the ring 530 is rotated, the pop opener 540 (see FIGS. 35 and 36) is engaged by the inclined portion 530 on the ring 582, the ring 530 so that the ejecting opening for the tool 540 and Belleville phase separation, release spring sombe 550 so that the pressurized contents of the container. 在按钮505第一次被放松之后,按钮505的线性元件508由于枢轴点506的弹力而缩回,放松第一激励环530第一棘爪509,并且定位在第二激励环棘爪516后面,如图30中所示的。 After the first button 505 is loosened, the linear member 505 of button 508 by the elastic force of the pivot point 506 is retracted, the first energizing ring 530 relaxed first pawl 509 and the pawl 516 is positioned behind the second excitation ring , 30 shown in FIG. 在这种情况下,第二次推动按钮505使得激励环530进一步转动,将弹簧510的相对调整片521放松到517中,并且将前面的下部弹簧调整片522向上伸到倾斜上部连杆513,允许歧管臂520升高并缩回患者针541,如图31中所示的。 In this case, the push button 505 so that the second energizing ring 530 is further rotated, the tabs 521 relative to the spring 510 to relax to 517, and the lower portion of the front of the spring tabs 522 out into the upwardly inclined upper link 513, the manifold 520 allows the arm 541 rises and patient needle is retracted, as shown in Figure 31.

除以上所述以外,按钮505还通过棘爪570与阀组件560相接合。 Other than those described above, button 505 is also engaged by the pawl 560 and valve 570 assembly. 稍后将参照图32和33更详细地描述的所述阀被推入到打开位置中,允许阀560和歧管臂520之间由连续路径561提供的流体连通。 33 with reference to FIGS. 32 and the valve described in more detail later, pushed into the open position, allowing fluid between the valve 560 and the manifold 520 by the arm 561 to provide a continuous path of communication. 如图32和33中所示的,阀组件560包括当处于关闭位置中时在接触表面562和设置在橡胶密封564中的增大近端571之间延伸的软塑料元件572。 And FIG. 32, the valve assembly 560 shown in FIG. 33 comprises, when in the closed position, the contact surface 562 and disposed between the increase in the soft plastic element extends at the proximal end 571 of the rubber seal 572 564. 阀组件560可被构成在歧管臂520(即,歧管臂520与容器550之间的模制连接内)中以便于在单个容器组件中提供连续的流体连通路径。 The valve assembly 560 may be configured in a manifold arm 520 (i.e., the molded arm is connected between the manifold 520 and the vessel 550) so as to provide a continuous fluid communication path in a single container assembly.

具体地,如图32中所示的,推动阀组件560包括滑动接合在与容器550流体连通的橡胶密封564中的软元件572。 Device Specifically, as shown in FIG. 32, the push valve assembly 560 includes a rubber seal 564 in sliding engagement in fluid communication with the container 550 in 572. 阀组件560具有初始状态和启动状态,并且包括具有远端径向突出毛刺或肋573组的大直径远端和延伸到增大近端571的减小直径主体。 The valve assembly 560 has an initial state and an active state, and a large diameter distal end comprising a distal end having a radially projecting burrs or ribs 573 extending to the set and increasing the reduced diameter proximal end 571 of the body. 在初始状态中,阀560远端肋673用于防止微生物进入流体路径574中,并且增大近端571形成密封以便于将药品安全地收集在容器550中。 In the initial state, the distal end of the rib 673 valve 560 for preventing microorganisms from entering the fluid path 574, and increases the proximal end 571 to form a seal to facilitate the drug safely collected in a container 550. 在长时间防止流体从容器的内部流失时以及在同样长时间内防止药品从容器外部被污染时,肋573组和端部571组两者都执行关键的任务。 In time preventing loss of fluid from the interior of the container when the outer container, and when the drug is prevented from contamination, both the set of ribs 571 and end groups 573 perform critical tasks in the same time.

在使用中,元件572将最终通过按钮505的移动被推入到启动状态下,并且在棘爪570和接触表面562之间接触。 In use, the element 572 will eventually be pushed by the button 505 moves into the activated state, and the contact between the pawl 570 and the contact surface 562. 如图33中所示的,元件572的移动使得增大近端571从与橡胶密封564相接合处前进,这允许药品从容器550中流出,越过增大近端571并且进入阀流体路径574。 Mobile shown, element 572 is increased so that the proximal end 571 in FIG. 33 proceeds from a rubber seal 564 at engagement, which allows the drug out of the reservoir 550, is increased beyond the proximal end 571 and inlet valve 574 in fluid path. 同时,远端肋573组也被自然推入,并且肋573本身的位置移动到这样一个位置,使得它们引导容器550中的流体、通过阀流体路径574、以及从流体路径561向下到患者针歧管(未示出)。 Meanwhile, the distal end of the rib 573 is also set NATURAL pushed, and the position of the ribs 573 move to a position of itself, so that they guide the fluid container 550, the fluid path through the valve 574, the fluid path from the patient and a needle 561 downwardly to manifold (not shown).

在图34、35和36中所示的第四实施例的第二型式中,可使用替换弹簧和阀型式取代图28到31中所示的模压金属片簧510和阀组件560。 In a fourth version of the second embodiment shown in FIGS. 34, 35 and 36, the springs and valves may be used alternatively substituted molded type metal leaf spring 510 and the valve assembly 560 shown in FIGS. 28 to 31. 在图34和35中,示出了具有基本为环形横截面并盘绕在容器550和歧管臂520上面的弹簧581。 In FIGS. 34 and 35, the spring 581 is shown having a substantially circular cross section and wound around the upper arm of the container 550 and the manifold 520. 另外,取代图28中所示的推动类型的阀组件560,可提供任何数量的阀组件584(诸如下面将更详细描述的)。 Further, to promote the substitution of the type shown in FIG. 28 in the valve assembly 560 may be provided any number of valve assembly 584 (such as described in more detail below). 另外,激励环和弹簧的组合可用在以上所述的其他实施例中。 Further, the combination of energizing ring and a spring used in the above other embodiments. 在这种情况下,可为激励环提供用于多个推动钮功能的好处。 In this case, the benefits may be provided for a plurality of push buttons for the functions of energizing ring.

图35和36还用于示出弹出开启工具540,当环530转动时,弹出开启工具540与倾斜部分582相接合,这用于将弹出开启工具540与贝式弹簧(未示出)相脱离,放松贝式弹簧,从而加压容器550内容物。 35 and 36 shows a further pop opener 540, when the ring 530 is rotated, the pop-up opening portion 582 is engaged with the inclined tool 540, the pop-up for which the opener 540 and a Belleville spring (not shown) from , put sombe spring, so that the pressurized contents of the container 550. 在图36中,示出了第二型式的弹出开启工具583,所述弹出开启工具583基本如上所述那样与倾斜部分582相接合。 In FIG 36, illustrates a second type popup opener 583, the opener 583 eject substantially as described above with the inclined portion 582 is engaged.

在图37到41中所示的装置的第五实施例中,示出了按钮设计700,其中也在一个多功能/步骤程序中执行装置的启动和激励。 In a fifth embodiment of the device shown in FIGS. 37 to 41, the design of the button 700 is shown, which is also a versatile starting and energizing means / step program execution. 图37到41是片状注射器或输液系统的第七实施例的横截面图。 FIGS 37-41 are cross-sectional view of a seventh embodiment of a sheet-like syringe or an infusion system. 图42到44是图37的片状注射器或输液系统的容器子配件的横截面图。 FIGS 42 to 44 are cross-sectional view of the container subassembly of the syringe or a sheet transfer system 37 of FIG. 图45到47分别是在关闭和打开位置中图37的片状注射器或输液系统的阀子配件的横截面图,以及图48是图37的片状注射器或输液系统的两个发射患者针歧管子配件的横截面图。 FIGS 45-47 are cross-sectional view of the valve subassembly in the closed and open position in FIG. 37 or the like injector infusion system, and FIG. 48 is a sheet-patient needle manifold injector transmit two or infusion system 37 of FIG. cross-sectional view of the tube fitting. 图49到53是图37的片状注射器或输液系统的示例装配步骤的视图。 FIGS. 49-53 are views of an example of a sheet assembly step syringe or an infusion system 37 of FIG.

在本发明的第五实施例中,输液装置700包括上部外壳705、容器710、贝式弹簧保持柄730、至少一个贝式弹簧735、容器膜740、患者针歧管745、至少一个患者微型针760、以及下部外壳770。 In a fifth embodiment of the present invention, the infusion device 700 includes an upper housing 705, a container 710, a Belleville holding handle 730, 735 at least one Belleville, a film container 740, the patient needle manifold 745, at least one patient microneedle 760, and lower housing 770. 在图42到44中更详细地示出了容器710,并且容器710还包括具有从阀组件750延伸到歧管745的流体连通路径713的外圆周臂711。 In FIGS. 42 to 44 in more detail shows the container 710, and container 710 further comprises a valve assembly extending from the manifold 750 to the fluid communication path 745 of an outer circumference of the arms 713 711. 容器710还包括设置得与膜740相对的刚性部分712,将物质俘获在它们之间并且将其布置得与阀组件750流体连通。 Container 710 further includes a set of rigid portion opposing film 740712, the material trapped between them and arranged to be in fluid communication with valve assembly 750. 歧管745可包含下面将参照图101详细描述的不同材料榫粘接部分746。 The manifold 745 may include a detailed description with reference to FIG tongue 101 below the bonding section 746 different materials. 装置还包括邻近于按钮780的阀组件750。 Further comprising means adjacent to the button 780 of valve assembly 750. 在图45到46中更详细地示出了阀组件750。 In FIGS. 45 to 46 in more detail shows the valve assembly 750. 最后,如下面将详细描述并示出的,提供了改良的安全组件以便于在使用后启动并防护微型针。 Finally, as will be described below in detail and illustrated, it provides improved safety and protection components in order to start the microneedle after use.

如图37到41中所示的,本发明的实施例700可被构成得提供了片状的、可佩带的、整装物质输液装置,所述装置可用于向患者输送多种药物。 , Embodiments of the present invention shown in FIG 37-41 700 may be configured to be provided a sheet-like, wearable, self-contained substance infusion device, the device may be used to deliver multiple drugs to a patient. 装置700在使用之前和使用期间提供了隐蔽式患者针760,并且所述装置700可通过设置在下部外壳770上的粘合表面(未示出)被固定于患者。 Before using the apparatus 700 provides patient needle 760 and concealed during use, and the apparatus 700 may be provided in the lower housing 770 on the adhesive surface (not shown) is secured to the patient. 通过按钮780的简单操作可实现适当布置之后装置700的启动。 After suitable arrangement may be achieved by a simple operation button 780 of the apparatus 700 to start. 具体地,按钮780的滑动接合用于放松贝式弹簧735,从而为容器710的内容物加压。 Specifically, the slide button release 780 for engagement sombe spring 735, so that the pressing of the contents of the container 710. 按钮780接合还用于打开阀组件750,在容器710内容物与患者微型针760之间形成连续的流体连通路径。 Button 780 is further configured to engage the valve assembly 750 is opened to form a continuous fluid communication path between the container 710 and the contents of the microneedle 760 patients. 最后,按钮780接合用于将支撑元件(未示出)与患者针歧管745相脱离,从而定位患者针760并且完成装置启动。 Finally, the button 780 for engaging the support element (not shown) with the patient needle manifold 745 is disengaged from the tube, thereby positioning the patient and the needle 760 to complete the startup device. 在实现上述功能时,按钮780接合还用于放松稍后将更详细地描述的安全组件,从而减少被患者针760刺到的危险。 In carrying out the above function, the button 780 engages the security component will be described in further detail later used to relax, thereby reducing the risk of patient needle 760 to puncture. 上述实施例的明显优点包括在单次按钮操作中实现这些功能的每一种的能力。 Significant advantage of the above-described embodiments include the ability of each of these functions are implemented in a single button operation. 另外,另一个明显优点包括,包含容器子配件的连续流体连通路径的使用。 In addition, another obvious advantage includes using a continuous fluid container comprising a subassembly communication path.

返回来参考图37,在基本如上所述那样适当地布置装置700之后,通过朝向装置向内滑动按钮780而启动装置700。 Referring back to FIG. 37, in suitably arranged as described above, after the basic device 700, device 700 is activated by sliding the button 780 inwardly toward the device. 该滑动接合朝向保持柄730驱动倾斜部分782。 The sliding engagement lever 730 toward the holding section 782 driving the tilt. 当倾斜部分782与保持柄730相接合时,保持柄730从固定贝式弹簧735的位置位移,使得弹簧735为容器710加压。 When the inclined portion 782 is engaged with the holding lever 730, displacement of the holding lever 730 from the fixed position of Belleville 735, the spring 735 so that container 710 is pressurized. 具体地,该步骤放松贝式弹簧735,允许其压制在容器710的挠性膜740上,为膜740与刚性部分712之间的容器内容物加压。 Specifically, this step is put sombe spring 735, allowing it to press on the flexible film 740 of the container 710, the pressurized container contents between the membrane 740 and the rigid portion 712. 该启动步骤还用于从歧管745下面使得支撑部分位移,放松通过外圆周臂711(或如上所述的任意数量的弹簧)的压缩被向下推压的患者针歧管745并且安放患者针760。 The initiating step further configured such that the manifold 745 below the support portion is displaced by the outer circumference of the relaxed arm 711 (or any number of springs as described above) is pushed down a compression pressure in a patient needle manifold 745 and patient needle mounted 760. 最后,启动步骤还用于打开阀组件750,在容器710与患者针760之间形成流体连通路径。 Finally, a further step start opening the valve assembly 750, a fluid communication path between the container 710 and the patient needle 760.

具体地,如图45、46和47的横截面图中所示的,阀组件750包括可滑动地接合在与容器710流体连通的橡胶止动器752中的塑料按钮751。 In particular, cross-sectional view shown in FIG. 45, 46 and 47, the valve assembly 750 comprises a slidably engages container 710 in fluid communication with the rubber stopper 752 of the plastic button 751. 阀组件750具有初始状态和启动状态,并且包括具有远端径向突出毛刺或肋753组的大直径远端和具有近端棘爪754组的减小直径近端。 The valve assembly 750 has an initial state and an active state, and includes a large diameter distal end having a distal end radially projecting burrs or ribs 753 having a set and a reduced diameter proximal end 754 of the pawl proximal end group. 在使用中,钮751将最终通过按钮780的移动被推入到启动状态下并且棘爪754组将从与橡胶止动器752相接合处前进,这允许药品从容器710中流出,越过棘爪754并且进入流体路径713。 In use, the button 751 will eventually move the button 780 is pushed through into the activated state and the pawl 754 from group 752 forward and engage the rubber stopper, which allows the drug out of the reservoir 710, past the detent 754 and 713 into the fluid path. 如上所述的,上述每个实施例的明显优点包括在单次按钮操作中实现每一步骤的能力。 As described above, the clear advantage of the above-described each embodiment include the ability to achieve each step in a single button operation. 另外,另一个明显优点包括,包含容器子配件的连续流体连通路径的使用。 In addition, another obvious advantage includes using a continuous fluid container comprising a subassembly communication path.

一系列装配图49到53示出了用于上述装置的一个示例装配。 Assembling a series of FIGS. 49 to 53 shows one example of the above-described apparatus for assembling. 在图49中,下部外壳770、固定贝式弹簧730按钮780被制备得用于接收容器和上部外壳。 In Figure 49, the lower housing 770, 730 fixed Belleville button 780 have been prepared for receiving the containers and an upper housing. 在图50中,容器710、歧管745(包括任选针帽719)被制备得下降到下部外壳770中,如图51中所示的。 In Figure 50, container 710, the manifold 745 (optionally including a needle cap 719) are prepared to obtain the lower housing 770 drops, as shown in FIG. 51. 在图52中,随后制备上部外壳705以便于下降到下部外壳770上,如图53中所示的。 In FIG 52, the subsequent preparation of the upper housing 705 so as to drop to the lower housing 770, as shown in FIG. 53.

在上述每个实施例中,输液装置的容器(即,图4的150)可由用于与一个或多个不可伸展但是挠性的膜(即,图4的151)(诸如金属膜)相连接的刚性部分(即,图4的152)构成,并且在第一和第二膜之间(其中第一膜和第二膜中的任意一个也被布置在刚性部分上)或是在第一膜和刚性部分之间可包含任何数量的物质。 In each embodiment described above, the container (i.e., 150 of FIG. 4) for the infusion device may be one or more inextensible but flexible film (i.e., FIG. 151. 4) (such as a metal film) is connected to rigid portion (i.e., 152 of FIG. 4) configuration, and between the first and second membranes (wherein any of the first film and the second film is also disposed on a rigid portion) or in the first film It may comprise any number of substances between the rigid portions. 刚性部分或容器基底可由容器的较硬部分构成并用作挠性膜可压制在其上的较硬部分。 Hard portion constituting the container can be rigid portion or base of the container and used as a flexible membrane which can be pressed harder the portion. 刚性部分可包含设在刚性部分外围周围用于热密封挠性膜的圆顶构架的中央部分和凸缘,或盖于刚性部分并且在它们之间形成内容物容器或腔室的膜盖。 The rigid portion may comprise a central portion and a flange portion provided around the periphery of the rigid film for heat sealing the flexible dome frame, or cover film in the rigid portion and the contents of the container or the lid of the chamber is formed therebetween. 由于腔室的至少一个壁包括挠性膜并且腔室的至少一个壁包括刚性表面,因此一个或多个贝式弹簧(即,图4的130)可被布置得邻近于挠性膜并且用于向挠性膜施加基本恒定的压力并且为容器腔室和内容物加压。 Since at least one wall of the chamber includes a flexible membrane and at least one wall of the chamber comprises a rigid surface, one or more Belleville (i.e., 130 of FIG. 4) may be disposed adjacent to the flexible membrane and for applying a substantially constant pressure to the flexible membrane and a pressurized chamber and the container contents.

如下面将更详细地描述的可具有弹簧随动器的贝式弹簧被设置得用于向容器的挠性膜施加基本均匀和恒定的压力,压制挠性膜和刚性部分之间的容器的内容物,并且经由所需的阀组件(即,图1的120)通过一个或多个流动路径从容器中压迫出内容物。 May have the contents as will be described in more detail with the Belleville spring pressure of the actuator is set to be used to apply a substantially uniform and constant to a flexible film container, pressing the container between the flexible membrane and the rigid portions was forced out and the required contents via the valve assembly (i.e., 120 of FIG. 1) via one or more flow path from the container. 如以上所提到的,容器也可由两个或多个挠性的、不可伸展的膜构成,其中内容物可被包含在所述膜之间并且至少一个膜被附于刚性部分以便于提供用于压制并为容器内容物加压的刚性基底。 As mentioned above, two or more containers may also be flexible, inextensible film, wherein the contents can be contained between the membrane and the at least one membrane is attached to the rigid portion so as to provide a to press the pressurized container contents and rigid substrates. 在容器子配件的另一个实施例中,从初始高速到一个或多个逐步降低的低流速自动地调节流速。 In another embodiment the container subassembly embodiment, the flow rate is automatically adjusted from an initial high speed to the one or more stepped-down lower flow rates. 在2003年3月26日申请的系列号为No.10/396,719的Jim Fentress等人的题为“Multi-Stage Fluid Delivery Device And Method”的美国专利申请中进一步描述了调节流速的其他细节,这里合并参考所述专利申请的全部内容。 In Series No. 2003 March 26 to apply for Jim Fentress, etc. No.10 / 396,719 person entitled "Multi-Stage Fluid Delivery Device And Method" of US patent application further describes other details of the regulation of the flow rate, here all incorporated by reference to the patent application.

容器子配件的挠性膜(即,图4的元件151)可由不可伸展的材料或层压材料制成,诸如金属涂覆膜或其他相似的物质。 Flexible film container subassembly (i.e., element 151 of FIG. 4) may be made of inextensible material or laminate, a metal coating such as a film or other similar substances. 例如,可用在第一实施例的容器中的一个可行性挠性层压膜(即,图4的元件151)可由本领域中普通技术人员公知的第一聚乙烯层、第二化学层构成以便于为基于屏蔽特性而选择的第三金属层提供附着机构,之后是由聚酯或尼龙构成的第四层。 For example, the feasibility of a flexible laminate film can be used in a container in the first embodiment (i.e., element 151 of FIG. 4) may be known in the art of ordinary skill in the first polyethylene layer, a second layer composed of a chemical to attachment means for providing a third metal layer is selected based shielding property, after the fourth layer is made of polyester or nylon. 通过使用与刚性部分相连接的金属涂覆膜或金属膜,提高了容器的屏蔽特性,从而增加或提高容纳于其中的内容物的保存期限。 By using the metal portion is connected to the rigid coating film or a metal film, to improve the shielding characteristics of the container, so as to increase or enhance the shelf life accommodated therein contents. 例如,在容器内容物包含胰岛素的情况下,上述实施例的容器中的主要接触材料包括线型低密度聚乙烯(LLDPE)、低密度聚乙烯(LDPE)、循环烯烃共聚物(COC)和特富龙。 For example, in the case where the contents of the container comprising insulin, primary materials of contact in the above embodiment the container comprises a linear low density polyethylene (LLDPE), low density polyethylene (LDPE), cyclic olefin copolymer (COC) and Laid Teflon. 如下面更详细地描述的,容器内容物的其余流动路径中的主要接触材料包括聚乙烯(PE)、药用等级丙烯酸以及不锈钢。 As described in more detail below, the remaining primary materials of contact in the flow path of the container contents include polyethylene (PE), a pharmaceutically acceptable acid, and grade stainless steel. 与容器的内容物延伸接触的所述材料最好通过ISO 10-993和其他适用的生物相容性测试。 Extending the material in contact with the contents of the container, preferably by ISO 10-993 biocompatibility and other applicable tests.

所述容器最好还能够在适用的可控环境中储存预定保存期限的容器内容物而不会对内容物造成不利影响并且最好能够在多种环境条件下使用。 The contents of the container is preferably further capable of storing a predetermined container shelf life in applicable controlled environments without adverse effect will content and preferably be used in a variety of environmental conditions. 另外,由容器的部件提供的防护不允许气体、液体和固体材料在大于满足所需保存期限的容许度的速度下传输到内容物中(或从其中传输出来)。 Further transmission speed tolerance, protection provided by the components of the container does not allow gas, liquids and solid materials to meet the desired shelf life greater than the contents of the next (or out from a transmission). 在以上所示出的实施例中,容器材料能够在大约华氏34到120度的温度范围内被储存和操作,并且可具有两到三年的保存期限。 In the embodiment illustrated in the above embodiment, the container material can be stored and operated in a temperature range of about 34 to 120 degrees Fahrenheit, and may have a shelf life of two to three years.

除满足稳定要求以外,所述容器还可通过成功地通过任何数量的漏渗试验(诸如在不会漏渗的前提下容纳30psi样品20分钟)来确保操作。 In addition to meeting stability requirements other than to ensure that the container can also operate successfully passed through any number of leakage to test (30psi samples such as housed, provided no leakage to 20 minutes). 除填充以外,由所述容器的结构带来的储存和输送优点还包括下面将更详细地描述的最小化预留空间和适应能力。 In addition to filling, caused by the structure of the container storage and delivery advantages include minimized headspace and adaptability will be described in detail.

在填充之前所述容器最好抽真空,如下面更详细地描述的。 Before filling the container is preferably evacuated, as described in more detail below. 通过在填充之前将所述容器抽真空,并且仅在坚硬底板或刚性部分中具有轻微下陷,可使得容器中的预留空间和过度浪费最小化。 By prior to filling the vessel was evacuated, and only a slight dip in hard or rigid bottom part, the container may be such that the headspace to minimize waste and excessive. 另外,可将容器的形状构成为适合于所使用的激励机构(例如,具有任意直径数量和高度尺寸的盘或贝式弹簧)的类型。 Further, the shape of the container can be configured to be suitable for the excitation mechanism used (e.g., having any diameter and number of trays or height dimensions Belleville) type. 另外,在填充期间使用抽真空的挠性容器使得所填充的容器中的任何空气或气泡最小化。 Further, during filling of the flexible container using a vacuum pump so that any air bubbles or the filled container is minimized. 当装置受到可导致增加内部容器压力的外部压力或温度变化时挠性容器的使用也是非常有利的。 When the device is subjected to external pressure can result in increase of the internal pressure of the vessel or container using a flexible temperature change it is very advantageous. 在这样的情况中,挠性容器膨胀并与内容物相接触,从而防止由于膨胀和收缩力导致的可能泄漏。 In such a case, the flexible container expands and comes into contact with the contents, thereby preventing possible leaks due to the expansion and contraction caused.

容器的另一个特征包括允许在填充时自动进行颗粒检查的能力,或者由使用者在使用时进行颗粒检查。 Another feature of the container include the ability to permit automated particulate inspection at the time of filling, or particle inspection performed by a user during use. 一个或多个容器屏障(诸如刚性部分)可由透明的、清澈的塑料材料模制而成,从而可检查容纳在容器中的物质。 A plurality of containers or barriers (such as a rigid portion) may be transparent, clear molded plastic material, which can check the substance contained in the container. 透明的、清澈的塑料材料最好为循环烯烃共聚物,所述循环烯烃共聚物的特征在于,高透明性和清晰度、低可提取性以及与容纳在容器中的物质的生物相容性。 A transparent, clear plastic material is preferably a cyclic olefin copolymer, the cyclic olefin copolymer is characterized in that high transparency and clarity, low extractables and biocompatibility with the substance housed in the container. 在所述应用中,容器包括可能阻碍检查的极小特征(即,在检查期间可进行转动)。 In the application, the container includes a minimum feature may hinder inspection (i.e., can be rotated during inspection).

在上述实施例中容器(即,图4的150)与患者微型针(即,图1中的141)之间的流体路径是由上面所述的与容器所用的那些相似或相同的材料构成的,并且满足多种生物相容性和储存测试。 In the above embodiment, the container (i.e., 150 of FIG. 4) with the patient microneedles (i.e., 141 in FIG. 1) between the fluid path is the same as those described above or consists of materials similar to the configuration of the container used and satisfies more biocompatible and storage test. 例如,如下面图表1中所示的,在装置内容物包含胰岛素的情况下,实施例的容器中的主要接触材料包括线型低密度聚乙烯、循环烯烃共聚物和特富龙,并且还可包括透明清澈的塑料。 For example, as shown in the chart below, when the contents of the device containing insulin, the main material of the container in contact with the embodiment comprises linear low density polyethylene, cyclic olefin copolymer and Teflon, and may also It comprises a transparent clear plastic. 容器和患者针歧管的微型针之间的其余流动路径中的主要接触材料包括乙烯、药用丙烯酸,和/或不锈钢。 Remaining primary materials of contact in the flow path between the container and the microneedles patient needle manifold comprising ethylene, a pharmaceutically acceptable acid, and / or stainless steel.

图表1 Chart 1

具体地,患者针(即,图1中的141)可由不锈钢制成,患者针歧管(即,图1中的140)可由乙烯和/或药用丙烯酸制成。 In particular, patients with a needle (i.e., in FIG. 1141) may be made of stainless steel, the patient needle manifold (i.e., 140 in FIG. 1) may be ethylene and / or a pharmaceutically acceptable made of acrylic. 当与容器的内容物延伸接触时,所述材料最好通过ISO10-993生物相容性测试。 When the extended contact with the contents of the container, said material preferably by ISO10-993 biocompatibility testing.

如每个实施例中所示的,在用于向容器中施加基本均匀、恒定力以便于从容器中压迫出内容物的装置中包括盘状或贝式弹簧(即,图1中的130),并且在下文中有时称之为恒力弹簧。 As shown in each embodiment, substantially uniformly applied to the vessel for a constant compression in order to force out of the container contents of the device comprises a Belleville or disc-shaped (i.e., in FIG. 1130) and a constant force spring sometimes referred to hereinafter. 恒力弹簧用于储存能量,从而在使用时当通过激励装置使之放松时为容器加压。 A constant force spring for storing energy, so that when the pressurized container is relaxed by the excitation means in use. 布置在多个弹簧夹中心处的保持盘(或柄(即,图1中的135))将贝式弹簧保持在弯曲状态下。 A plurality of spring clips disposed at the center of the retaining disk (or stem (i.e., in FIG 1135)) held in the Belleville bent state. 在这种情况下,在储存期间防止贝式弹簧在容器的膜(即,图4中的151)上或任何其余装置部件上施加压力。 In this case, the Belleville during storage to prevent application of pressure in the container the membrane (i.e., in FIG. 4151) or on any of the remaining apparatus components. 保持盘具有充足的刚性以抵抗弹簧张力和变形,并且在正常拉伸载荷下不会失效。 Holding plate has a sufficient rigidity to resist spring tension and deformation, and does not fail under normal tensile load.

当从贝式弹簧上拉离保持盘时,弹簧夹下降,在这种情况下,在容器的膜盖上施力。 When pulled away from the holding tray Belleville spring clip decreased, in this case, the membrane urging the container lid. 贝式弹簧的边缘被限制在容器的外圆周周围。 Belleville edge is limited around the outer circumference of the container. 为了进行皮内的容器内容物的输送,贝式弹簧可被构成得最好在容器中产生大约1到50psi的压力,更好的是产生大约2到25psi的压力,最好的是产生大约15到20psi的压力。 For transport container contents intradermal, Belleville best may be configured to generate a pressure of about 50psi in a container, more preferably 2 to generate a pressure of about 25psi, the best is to produce approximately 15 the pressure of 20psi. 为了进行皮下注射或输液,大约2到5psi范围内的压力可为足够的。 For subcutaneous injection or infusion, a pressure in the range of from about 2 to 5psi may be sufficient. 贝式弹簧的尺寸的直径可在1.15到1.50英寸之间,最好为1.26英寸,并且还包括用于全部600μl输送的弹簧随动器。 Belleville size diameter of between 1.15 to 1.50 inches, preferably 1.26 inches, and further comprising a follower spring for transporting all 600μl.

图55到60示出了各种型式贝式弹簧随动器800(a)到800(c)的示例,每个弹簧随动器都可与上述实施例中的贝式弹簧802结合使用。 55 to 60 shows various types of Belleville follower 800 (a) to Example 800 (c), each of the spring follower 802 can be used in combination with the Belleville above embodiments. 在每种型式中,位移元件800被设置得邻近于贝式弹簧802,以使得当贝式弹簧802在弯曲和放松位置(即,由保持元件放松)之间移动时,弹簧802在位移元件或随动器800上施加基本恒定的力,而不是直接在容器的挠性膜(即,图4中的151)上施力。 In each type, the displacement member 800 is disposed adjacent to the Belleville spring 802, so that when a Belleville 802 in bending and relaxed position (i.e., relaxed by the holding member) is moved between the spring 802 in the displacement element or follower 800 is applied to a substantially constant force on, rather than directly on the flexible membrane urging the container (i.e., 151 in FIG. 4). 随动器800又对容器膜804施加更均匀分布的力。 Follower 800 in turn applies a force on the container more evenly distributed film 804.

例如,如分别示出了弯曲和放松贝式弹簧802位置的图组55和56、57和58以及59和60中所示的,示例随动器800(a)、800(b)和800(c)与刚性容器壁806(a)、806(b)和806(c)的形状相符。 For example, as shown respectively bending 802 and discharge sombe spring group 55 and the position of FIGS. 56, 57 and 58 and, in the illustrated example 59 and 60 the follower 800 (a), 800 (b) and 800 ( c) a rigid container wall 806 (a), 806 (b) and 806 (c) a shape conforming. 因此,当如图56、58和60中所示的放松贝式弹簧802时,贝式弹簧802分别将随动器800(a)、800(b)和800(c)紧紧地压在刚性容器壁806(a)、806(b)和806(c)上,使得死角损失最小化。 Thus, when the discharge sombe spring 802 as shown in FIG. 56, 58 and 60, respectively Belleville follower 802 800 (a), 800 (b) and 800 (c) tightly against the rigid container wall 806 (a), the 806 (b) and 806 (c), so as to minimize dead loss. 为了进一步减小所述损失,也可提供如下面将参照图90到92更详细地描述的过度模制的贝式弹簧。 To further reduce the loss, as will also be provided over 90-92 molded Belleville described in more detail with reference to FIG.

以上描述的每个实施例还包含至少一个患者针,或微型针(即,图1的141),但是也可包含若干(诸如三个)微型针。 Each of the embodiments described above further comprises at least one patient needle or micro-needle (i.e., 141 of FIG. 1), but may also include a number (such as three) microneedles. 每个微型针最好至少为31规格或更小,诸如为34规格,并且被固定在可被布置得与容器流体连通的患者针歧管(即,图1中的140)中。 Each micro-needle is preferably at least 31 gauge or smaller, such as a size 34, and may be secured in the patient needle manifold arranged in fluid communication with the container (i.e., 140 in FIG. 1). 当在装置中包含不只一个微型针时,微型针也可具有不同的长度、或规格、或不同长度和规格的组合,并且沿主体长度可包含一个或多个孔,所述孔最好位于针尖部附近或针斜面(如果针具有斜面的话)附近。 When comprising more than one micro-needle device, the microneedles may have different, or a combination of different length and gauge length, or size, and may include one or more apertures along the length of the body, the needle holes are preferably located or near the vicinity of the needle bevel (if it has a slope needle).

在上述实施例中,当在比通常需要更大套管或针的直接注射器注射所需更长的时间下进行输液时,使用用于输送容器内容物的多个34规格针是实际的。 In the above embodiment, when the infusion at time greater than the direct injector typically requires the injection needle or cannula longer required, using 34-gauge needle for delivering a plurality of contents of the container it is practical. 在所披露的实施例中,可使用其目标为真皮或皮下空间的任何微型针,然而,以上所述的实施例包括长度为1和4mm之间(即,2mm)的皮下注射微型针,并且这些患者针的布置可为线性或非线性阵列,并且依具体应用所需可包括任何数量的针。 In an embodiment of the disclosure, which may be used to target any of the dermis or subcutaneous space of the microneedle, however, the above-described embodiments comprises a length of between 1 and 4mm (i.e., 2mm) hypodermic microneedles, and the patient needle arrangement may be linear or non-linear array, and depending on the particular application desired may include any number of needles.

患者针被布置在患者针歧管中。 Patient needle is disposed in the patient needle manifold. 在上述每个实施例的患者针歧管(即,图1的140)中,每个患者针具有至少一个流体连通路径,或进料槽。 Patient needle manifold in each of the above embodiments (i.e., 140 of FIG. 1), each having at least one patient needle fluid communication path, or a feed chute. 歧管可仅具有用于一个或多个患者针的一个路径,或者可提供分别向每个针输送内容物的多个流体路径或槽。 The manifold may have a path for one or more patient needles only, or may be provided separately or transporting a plurality of fluid paths tank contents to each needle. 这些路径或槽还可包括用于待输送的内容物的曲折路径,从而影响流体压力和输送速度,并且用作流动限制器。 These paths may comprise grooves or tortuous path for the contents to be delivered, thus affecting the fluid pressure and conveying speed, and serves as a flow restrictor. 取决于具体应用,患者针歧管中的槽或路径可在宽度、深度和结构方面改变,其中槽宽度通常在约0.015和0.04英寸之间,最好为0.02英寸,并且被构成得使得歧管中的死角最小化。 Depending on the application, the patient needle manifold slot or path may be changed in the width, depth and structure, wherein the slot width is typically between about 0.015 and 0.04 inches, preferably 0.02 inches, and is configured to be such that the manifold the dead space is minimized.

以上所述的装置适用于向患者(尤其是人类患者)分配各种物质,包括药物和药剂。 The above-described apparatus is suitable for dispensing various substances to a patient (in particular a human patient), including drugs and agents. 当用在文中时,药剂包括可通过身体膜和表面(特别是皮肤)被输送的具有生物活性的物质。 When used herein, the agent includes a substance having biological activity to be conveyed by the film body and the surface (especially the skin). 以下详细列示的示例包括抗生素、抗病毒剂、镇痛药、麻醉剂、减食欲药、治风湿药、抗抑郁药、抗组胺剂、抗炎药、抗肿瘤药、疫苗(包括DNA疫苗)等。 The following detailed examples listed include antibiotics, antivirals, analgesics, anesthetics, anorexics, antiarthritics, antidepressants, antihistamines, anti-inflammatory agents, antineoplastic agents, vaccines (including DNA vaccines) Wait. 可经真皮或皮下输送给患者的其他物质包括人生长激素、胰岛素、蛋白质、肽及其碎片。 Subcutaneously or intradermally may be delivered to a patient other substances including human growth hormone, insulin, proteins, peptides and fragments thereof. 蛋白质和肽可自然存在、合成或重组产生。 Proteins and peptides can be naturally occurring, synthesized or recombinantly produced. 另外,所述装置可用在细胞疗法中,如在树突细胞的期间。 Further, as it may be used in cell therapy during the dendritic cells in the device. 可从由本发明中使用的药物、疫苗等构成的组中选择出可根据本发明方法输送的其他物质,使用包含阿尔法-1抗胰蛋白酶、抗血管生成剂、抗感剂、布托啡诺、降血钙素及类似物、Ceredase、COX-II抑制剂、皮肤病药剂、双氢麦角胺、多巴胺作用药和拮抗药、脑啡肽和其他吗啡样肽、表皮生长因子、促红细胞生成素及类似物、促卵胞成熟激素、G-CSF、胰增血糖素、GM-CSF、granisetron、生长激素和类似物(包括生长激素释放激素)、生长激素拮抗剂、水蛭素和诸如Hirulog的水蛭素类似物、IgE抑制剂、胰岛素、insulinotropin及类似物、胰岛素类生长因素、干扰素、白细胞间介素、Leutenizing hormone、Leutenizinghormone释放激素和类似物、低分子量肝磷脂、M-CSF、胃复安、咪达唑仑、单克隆抗体、麻药滇痛剂、烟碱、非类固醇抗炎药、低聚糖、ondansetron、甲状旁腺激素及类似物、 May be selected from the group consisting of a drug used in the present invention, vaccine may be delivered out of the other substances according to the invention, containing alpha -1 antitrypsin, anti-angiogenic agent, an anti-sense agents, butorphanol, calcitonin and analogs, Ceredase, COX-II inhibitors, dermatological agents, dihydroergotamine, action of dopamine and antagonists, and other morphine-like peptide enkephalin, epidermal growth factor, erythropoietin, and analogs, follicle cells mature hormone, G-CSF, glucagon, GM-CSF, granisetron, growth hormone and analogs (including growth hormone releasing hormone), growth hormone antagonists, such as hirudin and hirudin similar Hirulog thereof, IgE inhibitor, insulin, insulinotropin and analogs, insulin-like growth factors, interferons, interleukins, Leutenizing hormone, Leutenizinghormone releasing hormone and the like, a low molecular weight heparin, M-CSF, metoclopramide, imidazole midazolam, monoclonal antibodies, Yunnan narcotic analgesics, nicotine, non-steroid anti-inflammatory drugs, oligosaccharides, Ondansetron, parathyroid hormone, and the like, 状旁腺激素拮抗剂、前列腺素拮抗剂、前列腺素、重组细胞可溶性受体、东莨菪碱、血清促效药和拮抗剂、Sildenafil、间羟舒喘宁、溶血栓药、组织纤溶酶原激活物、TNF--、以及TNF--拮抗剂、具有或不具有载体/辅剂的疫苗等药物进行的疾病的诊断、减轻或治疗,包括与成瘾性、关节炎、霍乱、可卡因成瘾性、白喉、破伤风、HIB、拉姆病、脑膜炎双球菌、麻疹、病毒性腮腺炎、风疹、水痘、黄热病、呼吸道合胞病毒、蜱传播日本脑炎、肺炎球菌、链球菌、伤寒症、流行性感冒、肝炎(包含A、B、C和E型肝炎)、中耳炎、狂犬病、脊髓灰质炎、HIV、副流感病毒、轮状病毒、Epstein Barr Virus、CMV、衣原体、非典型性嗜血杆菌、摩拉克氏菌属catarrhalis、人乳头瘤病毒、包含BCG的结核病、淋病、哮喘、atheroschlerosis malaria、E-大肠杆菌、阿尔茨海默氏痴呆、H.幽门、沙 Next thyroid hormone antagonists, Prostaglandin antagonists, Prostaglandins, Recombinant soluble cellular receptors, scopolamine, serum agonists and antagonists, Sildenafil, Hydroxyapatite salbutamol, thrombolytic agent, tissue plasminogen activator , TNF--, and TNF-- antagonists, drugs diagnosis of a disease vaccine with or without carriers / adjuvants performed, alleviating or treating, including addiction, arthritis, cholera, cocaine addiction, diphtheria, tetanus, HIB, Ram disease, meningococcus, measles, mumps virus, rubella, chicken pox, yellow fever, respiratory syncytial virus, tick-borne Japanese encephalitis, pneumococcus, streptococcus, typhoid , influenza, hepatitis (including A, B, C and hepatitis E), otitis media, rabies, polio, HIV, parainfluenza virus, rotavirus, Epstein Barr virus, CMV, chlamydia, atypical bloodthirsty Bacillus, Escherichia Mo Lake catarrhalis, human papilloma virus, tuberculosis comprising a BCG, gonorrhea, asthma, atheroschlerosis malaria, E- coli, Alzheimer's dementia, H. pylori, sand 氏菌、糖尿病、癌症、单纯疱疹、人类乳突淋瘤等有关的预防药和治疗用抗原(包括但不局限于亚基蛋白质、肽和多聚糖、多聚糖接合藻类、类毒素、基因基疫苗、活性减毒剂、reassortant、灭活、全细胞、病毒和细菌载体),以及包含诸如用于感冒的药剂、Anti-addiction药剂、抗过敏症的药剂、止吐剂、抗肥胖症的药剂、antiosteoporeteic、抗感染药物、镇痛剂、麻醉剂、减食欲药、治风湿药、抗咳喘剂、抗痉挛药、抗抑郁症药、抗糖尿病药物、抗组胺、抗炎药、抗偏头痛药、抗晕动病药物、止恶心药、抗肿瘤药、抗帕金森病药、止痒剂、抗精神病药、退热剂、抗胆碱能药、苯并二吖庚因拮抗药、血管扩张药(包括普通血管扩张药、冠状血管扩张药、外周血管扩张药以及脑血管扩张药)、骨刺激剂、中枢神经系兴奋药、激素类、催眠药、免疫抑制剂、肌肉松弛 Coli, diabetes, cancer, herpes, human papilloma and other drug-related prevention and treatment with antigen (including, but not limited to subunit proteins, peptides, and polysaccharides, polysaccharide bonding algae, toxins, genes based vaccines, reducing agent activity, reassortant, inactivated, whole cells, viral and bacterial vectors), and comprising an agent such as an agent for cold, anti-addiction agent, an anti-allergy agents, antiemetics, anti-obesity , antiosteoporeteic, anti-infectives, analgesics, anesthetics, anorexics, antiarthritics, anti-cough agents, antispasmodics, antidepressants, antidiabetic agents, antihistamines, anti-inflammatory agents, antimigraine agents, anti-motion sickness drugs, antinauseants, antineoplastic, antiparkinsonian agents, antipruritic, antipsychotic, antipyretics, anticholinergics, benzodiazepine antagonists due to vascular vasodilators (including general vasodilators, coronary vasodilators, peripheral vasodilators, and cerebral vasodilator), bone stimulating agents, central nervous system stimulants, hormones, hypnotics, immunosuppressives, muscle relaxants, 、拟迷走神经药物、拟副交感神经药、前列腺素类、蛋白质、肽、多肽以及其他高分子、精神兴奋药、镇静剂、性机能减退药和镇定剂等所有主要治疗剂的其他物质,以及诸如题为“Method of Intradermally Injecting Substances”的美国专利No.6,569,143中所述的结核菌素和其他超敏性药剂等主要诊断,这里合并参考所述专利的全部内容。 , To be vagus nerve drugs, other substances in all major therapeutic agents, parasympathomimetics, prostaglandins, proteins, peptides, polypeptides and other polymers, psychostimulants, sedatives, tranquilizers and drugs decreased sexual function, as well as entitled main diagnosis "Method of intradermally Injecting Substances" in the U.S. Patent No.6,569,143 tuberculin and other hypersensitivity agents and the like, herein incorporated by reference the entire contents of which patents.

可根据本发明的系统和方法输送的疫苗剂型可从由能够在人类病菌上诱发免疫反应的抗原或抗原成分构成的组中选择出来,所述抗原或抗原成分来自于HIV-1(诸如tat、nef,gp120或gp160)、人类疱疹病毒(HSV)、诸如gD或其衍生物或者直接早期蛋白(诸如来自于HSV1或HSV2的ICP27)、细胞巨化病毒(CMV(esp人类))(诸如gB或其衍生物)、轮状病毒(包括活性致弱病毒)、Epstein Barr Virus(诸如gp350或其衍生物)、水痘带状疱疹病毒(VZV,诸如gpI、II和IE63),或者来自于肝炎病毒,诸如肝炎B病毒(例如肝炎B表面抗原或其衍生物)、肝炎A病毒(HAV)、肝炎C病毒和肝炎E病毒,或者来自于其他病毒病原体,诸如副粘病毒:呼吸道合胞病毒(RSV,诸如F和G蛋白质或其衍生物)、副流感病毒、麻疹病毒、腮腺炎病毒、人乳头瘤病毒(例如HPV6、11、16、18等HPV)、flaviviruses(例如,黄热病病毒、登革热病毒、蜱 Vaccine formulation can be selected according to the system and method of the present invention is delivered from the group consisting capable of eliciting an immune response in human pathogen antigen or component out, the antigen or antigenic composition derived from HIV-1 (such as tat, nef, gp120 or gp160), human herpes virus (HSV), such as gD or derivatives thereof or immediate early proteins (such as from HSV1 or HSV2 in ICP27), cytomegalovirus (CMV (esp human)) (such as gB or derivatives thereof), rotavirus (including active attenuated viruses), Epstein Barr virus (such as gp350 or derivatives thereof), varicella zoster virus (VZV, such as gpI, II and IE63), or from a hepatitis virus, such as hepatitis B virus (for example hepatitis B surface antigen or a derivative thereof), hepatitis A virus (of HAV), hepatitis C virus and hepatitis E virus, or from other viral pathogens, such as paramyxoviruses: respiratory syncytial virus (of RSV, such as F and G proteins or derivatives thereof), parainfluenza virus, measles virus, mumps virus, human papilloma virus (e.g. HPV6,11,16,18 et HPV), flaviviruses (e.g., yellow fever virus, dengue virus ,tick 播脑炎病毒、日本脑炎病毒)或流感病毒(卵细胞或MDCK细胞中生长的终身或不活化病毒、分裂流感病毒,或者全流感病毒颗粒或精制或其重组细胞蛋白质,例如HA,NP,NA或M蛋白质,或其组合),或者来自于诸如奈瑟氏菌属spp的细菌性病原体,包括N.淋病和N.meningitidis(例如荚膜多糖及其接合藻类、铁传递蛋白结合蛋白质、乳铁传递蛋白结合蛋白质、PilC、粘附素);S.金黄色酿脓葡萄球菌(例如M蛋白质或其碎片,C5A蛋白酶、脂磷壁酸质类),S.agalactiae,S.突变;H.ducreyi;摩拉克氏菌属spp,包括M catarrhalis,也称作布兰汉氏球菌属catarrhalis(例如高分子量和低分子量粘附素和侵袭素);博尔德氏杆菌spp,包括B.百日咳(例如pertactin、百日咳毒素或其衍生物、filamenteous红血球凝聚素、腺苷酸环化酶、菌毛),B.副百日咳和B.bronchiseptica;分支杆菌spp,包括M.结核病(例如ESAT6 Broadcast encephalitis virus, Japanese Encephalitis Virus) or Influenza virus (egg or MDCK cells grown life or inactivated virus, split influenza virus, or purified whole influenza virus particles or cells, or a recombinant protein such as HA, NP, NA or M proteins, or combinations thereof), or derived from bacterial pathogens such as Neisseria spp, including N. gonorrhea, and N.meningitidis (for example capsular polysaccharides and algal engagement, transferrin binding proteins, lactoferrin transferrin binding protein, PILC, adhesins);.. S Staphylococcus aureus (e.g. M proteins or fragments thereof, C5A protease, lipoteichoic acid substance class), S.agalactiae, S mutation; H.ducreyi ; Mo Lake Escherichia spp, including M catarrhalis, also known as Branhamella catarrhalis genus (e.g. high and low molecular weight adhesins and invasins); Boulder Bordetella spp, including B. pertussis (e.g. pertactin, pertussis toxin or derivatives thereof, filamenteous hemagglutinin, adenylate cyclase, fimbriae), B parapertussis and B.bronchiseptica;. Mycobacterium spp, including M. tuberculosis (for example ESAT6 抗原85A、-B或-C),M.bovis、M.麻风杆菌、M.avium、M.副结核M.smegmatis;Logionella属spp,包括L.pneumophila;埃希氏菌属spp,包括enterotoxic E.大肠杆菌(例如,移生因子、热不稳定毒素或其衍生物、热稳定毒素或其衍生物)、enterohemorragic E.大肠杆菌、致肠病的E.大肠杆菌(例如shiga毒素状毒素或其衍生物);弧菌spp,包括V.霍乱(例如霍乱毒素或其衍生物);志贺氏菌属spp,包括S.sonnei、S.dysenteriae、S.flexnerii;耶尔森氏菌属spp,包括Y.enterocolitica(例如,Yop蛋白质)、Y.鼠疫、Y.假结核病;Campylobacter spp,包括C.jejuni(例如毒素、粘附素和侵袭素)以及C.大肠杆菌;沙门氏菌spp,包括S.typhi、S.paratyphi、S.choleraesuis、S.肠炎;李司忒氏菌属spp,包括L.monocytogenes;哈比特属spp,包括H.幽门(例如尿素酶、过氧化氢酶、具液泡的毒素);假单胞菌spp,包括P.aeruginosa;葡萄状球菌spp,包括S.aureus、 . Antigen 85A, -B or -C), M.bovis, M leprae, M.avium, M paratuberculosis M.smegmatis;. Logionella genus spp, including L.pneumophila; Escherichia spp, including enterotoxic E coli (e.g., colonization factors, heat-labile toxin or derivatives thereof, heat-stable toxin or derivatives thereof), enterohemorragic E. coli, enteropathogenic E. coli (for example shiga toxin-like toxin or derivatives); Vibrio spp, including V. cholera (for example cholera toxin or derivatives thereof); Shigella spp, including S.sonnei, S.dysenteriae, S.flexnerii; Yersinia spp, . comprising Y.enterocolitica (e.g., Yop protein), Y plague, Y pseudotuberculosis; Campylobacter spp, including C. jejuni (for example toxins, adhesins and invasins) and C. coli; Salmonella spp, including S. typhi, S.paratyphi, S.choleraesuis, S colitis;. genus Listeria spp, including L. monocytogenes; Habte genus spp, including H. pylori (for example urease, catalase, with the bubble toxin ); Pseudomonas spp, including aeruginosa; Staphylococcus spp, including S.aureus, S.Epidermidis;肠球菌spp,包括E.faecalis、E.faecium;梭菌属spp,包括C.tetani(例如破伤风毒素及其衍生物)、C.肉毒杆菌(例如肉毒杆菌毒素及其衍生物)、C.difficile(例如梭菌毒素A或B及其衍生物);杆菌spp,包括B.anthracis(例如,肉毒杆菌毒素及其衍生物);棒状杆菌属spp,包括C.diphtheriae(例如白喉毒素及其衍生物);包柔氏螺旋体菌spp,包括B.Burgdorferi(例如,OspA、OspC、DbpA、DbpB)、B.garinii(例如,OspA、OspC、DbpA、DbpB)、B.afzelii(例如,OspA、OspC、DbpA、DbpB)、B.andersonii(例如,OspA、OspC、DbpA、DbpB)、B.Hermsii;Ehrlichia spp,包括E.equi和人类Granulocytic Ehrichiosis;立克次氏体属spp,包括R.rickettsii;衣原体spp,包括C.Trachomatis(例如,MOMP、肝磷脂结合蛋白质)、C.肺炎(例如MOMP,肝磷脂结合蛋白质)、C.psittaci;钩端螺旋体spp,包括L.interrogans;密螺旋体spp,包括T.苍白球(例如,稀薄外膜蛋白) S. epidermidis; Enterococci spp, including E.faecalis, E.faecium; Clostridium spp, including C.tetani (e.g. tetanus toxin and derivatives thereof), C botulinum (for example botulinum toxin and. derivatives thereof), C. difficile (e.g. toxin A or B and derivatives thereof); Bacillus spp, including B.anthracis (e.g., botulinum toxin and derivatives thereof); Corynebacterium spp genus, including C.diphtheriae (for example diphtheria toxin and derivatives thereof); Borrelia burgdorferi bacterium spp, including B.Burgdorferi (e.g., OspA, OspC, DbpA, DbpB), B.garinii (e.g., OspA, OspC, DbpA, DbpB), B. afzelii (e.g., OspA, OspC, DbpA, DbpB), B.andersonii (e.g., OspA, OspC, DbpA, DbpB), B.Hermsii; Ehrlichia spp, including human and E.equi granulocytic Ehrichiosis; genus Rickettsia spp, including R.rickettsii; Chlamydia spp, including C. trachomatis (for example, MOMP, heparin-binding proteins), C pneumoniae (e.g. MOMP, heparin-binding proteins), C.psittaci;. Leptospira spp, including L. interrogans; Treponema spp, including T. globus pallidus (e.g., thin outer membrane protein) 、T.denticola、T.hyodysenteriae;或者来自于诸如变形体spp的诸虫,包括P.Falciparum;弓型属spp,包括T.gondii(例如SAG2、SAG3、Tg34);肠阿米巴属spp,包括E.histolytica;巴贝虫属spp,包括B.microti;锥虫属spp,包括T.cruzi;贾第鞭毛虫属,包括G.兰氏鞭毛虫属;Leshmania spp,包括L.major;肺囊虫属spp,包括P.Carinii;毛滴属spp,包括T.vaginalis;Schisostoma spp,包括S.mansoni;或来自于酵母,诸如念珠菌属spp,包括C.乳头状体;隐球菌属spp,包括C.neoformans,如题为“VaccineDelivery System”的PCT专利公开号No.WO 02/083214中所述的,这里合并参考所述专利的全部内容。 , T.denticola, T.hyodysenteriae; or derived from parasites such as Plasmodium spp, including P. falciparum; bow genus spp, including T. gondii (for example SAG2, SAG3, Tg34); intestinal amoeba genus spp, comprising E.histolytica; Babesia spp, including B.microti; Trypanosoma spp, including T.cruzi; Giardia spp., including G. lamblia Portland genus; Leshmania spp, including L. major; lung cysticercosis spp genus, comprising of P. carinii; hair dropwise genus spp, including T.vaginalis; Schisostoma spp, including S.mansoni; or derived from yeast such as Candida spp, including C. papillary body; Cryptococcus spp PCT Patent, including C.neoformans, titled as "VaccineDelivery System" in the Publication No. No.WO 02/083214, the entire contents of which herein incorporated by reference to the patent.

还包括其他用于M.结核病的优选特效抗原,例如Tb Ral2、TbH9、Tb Ra35、Tb38-1、Erd 14、DPV、MTI、MSL、mTTC2以及hTCC1。 Preferably further comprising other effects for M. tuberculosis antigens, for example Tb Ral2, TbH9, Tb Ra35, Tb38-1, Erd 14, DPV, MTI, MSL, mTTC2 and hTCC1. 用于M.结核病的蛋白质还包括其中至少两个(最好为三个)多肽M.结核病被合并成更大蛋白质的熔化蛋白质及其变体。 For M. tuberculosis protein further comprises at least two (preferably three) M. tuberculosis polypeptide are merged into a larger protein fusion proteins and variants thereof. 优选聚变包括Ra12-TbH9-Ra35、Erd14-DPV-MTI、DPV-MTI-MSL、Erd14-DPV-MTI-MSL-mTCC2、Erd14-DPV-MTI-MSL、DPV-MTI-MSL-mTCC2、Tb H9-DPV-MTI。 Preferably comprises a fusion Ra12-TbH9-Ra35, Erd14-DPV-MTI, DPV-MTI-MSL, Erd14-DPV-MTI-MSL-mTCC2, Erd14-DPV-MTI-MSL, DPV-MTI-MSL-mTCC2, Tb H9- DPV-MTI. 用于衣原体的最优选的抗原包括例如高分子量蛋白质(HWMP)、ORF3、以及假定膜蛋白质(Pmps)。 Most preferred antigens for Chlamydia include for example the High Molecular Weight Protein (HWMP), ORF3, and assuming membrane proteins (Pmps). 优选细菌疫苗包括来自于链球菌spp的抗原,包括S.pneumoniae(例如荚膜多糖及其接合藻类、PsaA、PspA、链球菌溶血素、胆碱-结合蛋白质)以及蛋白质抗原肺炎球菌溶血素(生物化学Biophys Acta,1989,67,1007;Rubins等人,微生物致病原因,25,337-342),以及其突变异种解毒衍生物。 Preferred bacterial vaccines comprise antigens derived from Streptococcus spp, including S. pneumoniae (for example capsular polysaccharides and algal engagement, PsaA, PspA, streptolysin, choline - binding proteins) and the protein antigen Pneumolysin (Biological chemical Biophys Acta, 1989,67,1007; Rubins et al., microbial pathogenesis, 25,337-342), and mutant detoxified derivatives thereof. 其他优选菌苗包括来自于嗜血杆菌spp的抗原,包含H.influenzae类型B(“Hib”,例如PRP及其接合藻类)、非典型性H.infiuenzae,例如OMP26、高分子量粘附素、P5、P6、蛋白质D和脂蛋白D,以及丝束蛋白和丝束蛋白衍生肽或多份复制变体或其熔合蛋白质。 Other preferred vaccine comprises from Haemophilus spp antigens, comprising a H.influenzae type B ( "Hib", for example PRP and engaging algae), atypical H.infiuenzae, for example OMP26, high molecular weight adhesins, P5 , P6, protein D and lipoprotein D, and fimbrin and fimbrin derived peptides or parts thereof or fusion protein variant replication. 肝炎B的衍生物表面抗原是本领域中公知的,并且其中包括PreS1、PreS2S抗原。 Hepatitis B surface antigen derivatives are well known in the art, and include PreS1, PreS2S antigen. 在一个优选方面中,本发明的疫苗剂型包括HIV-1抗原、gp120,尤其是当表示在CHO细胞中时。 In a preferred aspect, the dosage forms of the vaccine of the present invention comprises a HIV-1 antigen, of gpl20, especially when expressed in CHO cells while. 在另一个实施例中,本发明的疫苗剂型包括上文中限定的gD2t。 In another embodiment, the vaccine formulations of the invention as defined hereinabove comprises gD2t.

除以上列示的物质输送以外,所述装置和方法也可用于从患者那里抽取物质,或监控患者中某种物质的水平。 Addition to the above listed material transport, the apparatus and method may also be used to extract material from the patient, or monitoring a substance level in the patient. 可被监控或抽取的物质的示例包括血液、间质液或血浆。 Examples of substances that can be monitored or withdrawn include blood, interstitial fluid or plasma. 之后可分析所抽取的物质以便于进行分析元素、葡萄糖、药物等方面的分析。 After the analyte can be extracted in order to facilitate analysis of the elemental analysis, glucose, drugs and the like.

以上所述的本发明的实施例最好包括推动表面(即,按钮)设计,其中所述装置可被布置和固定于皮肤表面,并且通过轻轻地压制按钮或推动表面被激励和/或启动。 The above-described embodiments of the present invention preferably comprises a pushing surface (i.e., button) design, where the means may be disposed and fixed to the skin surface, and is excited and / or activated by pressing a button or lightly pushing surface . 具体地,在第一个步骤中,使用者从无菌包装中取出所述装置并且移除粘合盖(未示出)和/或针帽。 Specifically, in a first step, the user removes the device from the sterile packaging is removed and the adhesive cover (not shown) and / or the needle cap. 在从无菌包装中取出所述装置并且在使用之前,上述特征允许使用者检查装置和其中的内容物两者,包括检查部件的缺失和损坏、有效日期、模糊或颜色改变药物等。 In removing the device from the sterile packaging and prior to use, the above feature allows the user to check the contents of both the object and the apparatus therein, including deletion, and damage to the checking means, expiration date, drugs blur or color change. 在使用之后,使用者可再次检查装置以确保已输送了全部剂量。 After use, the user can check the delivery device again to make sure the entire dose. 在这一点上,如下面详细描述的,所述装置也可包括有效剂量指示器,或者例如由可读规格面积构成的给药剂量指示器,所述可读规格区域为装置外壳的表面面积的至少20%并且精确到标记剂量的+/-10%。 At this point, as described in detail below, the device may also comprise an effective dose indicator or dose indicator for example, composed of a readable area size, the size-readable unit area of ​​a surface region of the housing and at least 20% accurate to +/- 10% of the labeled dose.

下一个步骤是将装置布置并应用于使用者的皮肤表面。 The next step the apparatus is arranged and applied to the skin surface of the user. 像片一样,使用者可将所述装置牢固地压制在皮肤上。 Photograph as a user of the device can be pressed firmly on the skin. 所述装置包括具有将装置固定于使用者皮肤的粘合层的底表面。 The apparatus comprises a means fixed to a bottom surface of the adhesive layer of the skin of the user. 该底表面可为平坦的、弯曲形状的或任何适当形状的,并且其上包括粘合层,在运输之前最好将其覆盖。 The bottom surface of the adhesive layer may comprise a flat, a curved shape or any suitable shape, and which is preferably covered prior to shipping. 在使用之前,使用者剥离粘合剂覆盖层(诸如覆盖粘合剂的膜),从而露出用于布置在皮肤上的粘合剂。 Before use, the user peelable adhesive covering layer (such as a film covering the adhesive), arranged so as to expose the adhesive used on the skin.

在取出之后,使用者可将装置放置在皮肤上并且进行压制以确保适当的粘合。 After removal, the user can place the device on the skin and pressed to ensure proper bonding. 如上所述的,在适当定位之后,通过滑动按钮(即,图1中的105)或压制顶部外壳的推动表面(即,图1中的305)而启动所述装置。 As described above, after appropriate positioning by the slide button (i.e., 105 in FIG. 1) or pushing the pressing surface of the top of the housing (i.e., 305 in FIG. 1) to activate the device. 该启动步骤放松贝式弹簧,将其压制在容器的挠性膜上,为容器加压。 The activation step release sombe spring, which is pressed on the flexible film container, the container is pressurized. 该启动步骤还用于放松患者针歧管并且使得患者针就位。 The initiating step further relax for patient needle manifold and the needle in place so that the patient. 最后,启动步骤还用于打开如上所述的一个或多个阀组件或流动路径,在容器和患者针之间形成流体连通路径。 Finally, the initiating step as described above is also used to open the valve assembly or the one or more flow paths in fluid communication path between the container and the patient needle. 以上所述的每个实施例的明显优点包括在单次推动操作中实现每个步骤的能力。 Each distinct advantage of the above-described embodiments include the ability to achieve each step in a single push operation. 另外,另一个明显优点包括完全位于容器组件中的连续流体连通路径的使用。 In addition, another obvious advantage includes using a continuous fluid located entirely communication path in the container assembly.

在被启动之后,使用者通常将所述装置留在适当的位置中,或者佩带所述装置一段时间,诸如十分钟到二十二小时以便于完全输送装置内容物,之后在不会伤害皮下组织的前提下移开并丢弃所述装置。 After being activated, the device user typically left in place in the device or wear over time, such as ten minutes to January 22 hours for complete delivery of the contents in the apparatus, will not hurt after subcutaneous remove and discard the device under the premise. 然而,在故意或意外移除的情况下,如下面更详细地描述的,可使用一种或多种安全措施以遮蔽由于启动而导致露出的针。 However, in the case of deliberate or accidental removal, as described in more detail below, may use one or more security measures to shield the exposed result due to the start of the needle. 然而如果未推动按钮和按钮滑动并且患者针延伸的话所述安全措施也可被构成得不用使用,避免预使用安全装置。 However, if not the push button and the button slide and the patient if the needle extends security measures may also be configured to be not used, to avoid the use of pre-safety devices.

为了避免无意或意外的针刺、装置的有意重复使用,以及为了保护露出的针,可提供锁定针安全机构并且在从皮肤表面移除装置之后立刻自动地启动锁定针安全机构。 To avoid the inadvertent or accidental needle sticks, the device intends to be reused, and in order to protect the exposed needle, the needle locking safety mechanism may be provided and automatically activate the safety mechanism locking the needle immediately after removal of the device from the skin surface. 在下面更详细地描述的安全特征实施例的第一型式中,可提供挠性安全元件,所述挠性安全元件部分地提供粘合剂覆盖的与患者皮肤相接触的平坦表面部分。 The first version of embodiment of the security features described below in more detail, the flexible security element may be provided, in part, the flexible security element provides a flat surface portion in contact with the patient's skin covered by the adhesive. 一旦被放松之后,皮肤表面使得该元件保持在适当位置处。 Once you are relaxed, the skin surface so that the element remains in place. 在从皮肤表面移除所述装置之后,所述元件延伸到保护患者微型针的位置处。 After removing the device from the skin surface, said extending member to a position to protect the patient microneedles. 之后延伸的安全元件被锁定在位置处并且防止意外伤害或暴露患者针。 After the security element is locked at the extended position and to prevent accidental injury or exposure to patient needle. 安全特征实施例的另一种型式包括挠性患者针帽(即,图1的111),其用于保护患者针并提供无菌保护。 Another type of embodiment includes a flexible patient needle safety cap features (i.e., 111 of FIG. 1), and to protect the patient needle for providing a sterile protection. 所述患者针帽用于在装置制造期间保护患者针,在使用之前保护使用者,并且在移除之前的任意时候提供无菌保护。 The patient needle cap for the needle to protect the patient during the manufacturing apparatus, a user is protected prior to use, and provide a sterile protection at any time before removal. 可通过压配合将针帽与患者针歧管相连接。 The needle cap may be the patient needle manifold is connected by a press fit.

除以上所述的性能特征以外,以上所述的实施例的另一个特征是形成两个或多个可灵活装配的不同整装子配件(即,容器子配件和主体子配件)的能力。 Addition to the performance characteristics of the above, another feature of the above embodiment is formed in two or more different flexible monolith assembled subassembly (i.e., the container subassembly and the body subassembly) capability. 每个子配件都是整装的并且是稳定的,并且具有将容器子配件与其余部件相分离的能力,可分离容器的填充与检查,同时避免对于其余部件的不必要的处理。 Each subassembly is self-contained and stable, and has the ability to rest of the container subassembly and separate member, filling the container with a detachable inspection, while avoiding unnecessary processing for the remaining components. 另外,如果任何其余部件都应被丢弃的话,就会浪费地丢弃容器内容物。 Further, if any of the remaining components are intended to be discarded, it would wastefully discard the contents of the container. 另外,容器子配件不包含不必要的部件,因此会对填充操作带来低颗粒载荷。 Further, the container subassembly does not include unnecessary parts, so the filling operation will bring low particulate loading. 另外,所有的储能部件都在主体子配件中因此在容器的填充期间它们不会因疏忽而被展开。 Further, all of the energy storage component are in the body subassembly in the container during filling so they will not inadvertently be deployed. 具体地,在容器子配件中不包含弹簧,这防止在填充期间出现不期望的弹簧放松的机会。 Specifically, in the container subassembly is not included in the spring, which prevents unwanted spring chance to relax occur during filling. 如以上所述的,容器子配件中的最少外加组分减少了颗粒载荷,并且只包含必要的部件,诸如容器和盖。 As described above, plus a minimum of component container subassembly reduce particulate loading, and only contain the necessary components, such as container and lid. 不存在悬浮部件,并且通常只需要插入装配部件。 Suspension member does not exist, and typically only inserted into the fitting member. 另外,所述容器可被放置在装置的顶部上,这可通过透明部件填充并清楚地观察药剂容器,从而允许使用者或制造者观察容器内容物。 Further, the container may be placed on top of the device, which may be filled by a transparent member and is clearly observed drug container, thereby allowing the manufacturer or user to observe the contents of the vessel.

上述示范性实施例中所提供的任何数量的部件都可具有辅助功能和特征以更好地实现期望结果。 Any number of components provided in the embodiment above-described exemplary embodiments may have auxiliary functions and features to better achieve the desired results. 具体地,示范性实施例可使用如下面将更详细地描述的改良材料、阀和贝式弹簧结构、安全和包装方法和材料,从而实现期望结果。 In particular, the exemplary embodiments may be modified using materials as described in more detail below, the valve structure and Belleville, safety and packaging methods and materials to achieve a desired result. 例如,返回来参照图1,按钮105与推动阀120相接合,启动目前加压的容器150与歧管组件140之间的流动。 For example, referring back to FIG. 1, the button 105 engages and pushes the valve 120, to start the current flow between the pressurized container 150 and the manifold assembly 140. 图1中所示的实施例的推挽式阀组件120被构成得用于在被按钮105推动到打开位置中之前限制容器150与患者针歧管140之间的流动,并且可由下面将更详细地描述的任何数量的改良阀组件构成。 Push-pull valve assembly of FIG. 1 shown in the embodiment 120 is configured to be used to limit the button 105 pushed to an open position in the container prior to flow between the manifolds 140,150 and patient needle tube, and in more detail by the following any number of improved valve assemblies described configuration.

如图61到63中所示的,改良阀组件1200可由放置在通过路径1202与容器(未示出)流体连通的外壳1203中的开口1201中的推挽式阀杆1206构成。 As shown in FIG. 61 to 63, the improved valve assembly 1200 through the path 1202 may be placed in a container (not shown) in fluid communication with the opening 1201 in the housing 1203 of stem 1206 in a push-pull configuration. 图61和63示出了处于关闭位置中的拉阀1200和1400,图64示出了处于关闭位置中的推动阀1500。 61 and FIG. 63 shows the pull valve 1200 is in the closed position and 1400, FIG. 64 shows a push valve 1500 in a closed position.

传统阀组件通常包括可滑动地接合在与容器流体连通的橡胶止动器中的塑料元件,其中所述塑料元件包括固定地放置于橡胶止动器中的近端以阻止任何流体漏出容器。 Conventional valve assembly generally includes a plastic element slidably engaged in a rubber stopper in fluid communication with the container, wherein the plastic element comprises a fixedly disposed to the proximal end of the rubber stopper to prevent any leakage of the fluid container. 由于通过按钮将塑料元件接合在橡胶止动器中并在橡胶止动器中位移,因此在塑料元件的近端处形成开口,这允许与容器流体连通。 Since the plastic element via the button engages the rubber stopper and the rubber stopper is displaced, and thus an opening is formed at the proximal end of the plastic element, which allows fluid communication with the container. 然而,所述组件需要独立的橡胶塞或止动器,塑料元件的近端被放置于其中。 However, the components need to separate the rubber stopper or the stopper, the proximal end of the plastic element is placed therein.

在图61到63中,示出了阀实施例1200、1300和1400,其中阀主体1206、1306和1406是由弹性体构成的。 In FIGS. 61-63, there is shown an embodiment of a valve 1200, 1300 and 1400, 1206,1306 and 1406 in which the valve body is made of an elastic material. 所述阀和阀肋1207、1307和1407是部分由弹性体构成的,这可省却独立的橡胶塞或密封(即,图6的224)。 The ribs and valves 1207,1307 and 1407 are partially made of elastomer, which can be dispensed independently or sealing rubber stopper (i.e., 224 of FIG. 6). 另外,图62和63的阀具有足以避免肋1307和1407与流体路径泄漏口1204和1304相接触并损坏的线性测量。 Further, valves 62 and 63 sufficient to avoid having linear ribs 1307 and 1407 measure the fluid leakage paths 1204 and 1304 in contact with and damaged.

具体地,在图61到63中的每个中,都提供与容器(未示出)流体连通的开口1202、1302和1402。 Specifically, in each of FIGS. 61 to 63 are provided with a container (not shown) in fluid communication opening 1202, 1302 and 1402. 还提供与患者针歧管(未示出)流体连通的第二开口1204、1304和1404。 The second opening also provides 1204,1304 patient needle manifold (not shown) in fluid communication and 1404. 当阀主体1206、1306和1406从关闭位置移动到打开位置时,阀主体1206、1306和1406的密封元件或肋1207、1307和1407分别移动以便于分别在开口1202和1204之间、开口1302和1304之间、开口1402和1404之间提供流体连通路径。 1206,1306 and 1406 when the valve body is moved from the closed position to the open position of the valve body and the sealing member or ribs 1206,1306 1406, 1207,1307 and 1407 move, respectively, so as to respectively between the openings 1202 and 1204, and openings 1302 1304 between the openings to provide fluid communication path between 1402 and 1404. 然而,不允许所述密封元件以允许开口边缘以磨损方式作用在阀主体1206、1306和1406或密封元件1207、1307和1407上的方式接触开口(尤其是开口1204、1304和1404)。 However, the sealing member is not allowed to act to allow the edge of the opening in contact with the valve body wear mode 1206,1306 and 1207,1307 and 1406 or the sealing element 1407 on the way to the opening (openings 1204,1304 and 1404 in particular). 在每个阀实施例1200、1300和1400中通过在打开或关闭阀位置中在密封元件1207、1307和1407与开口1204、1304和1404之间提供充足的间隙而避免这一点。 Example embodiments each valve 1200, 1300 and 1400 by opening or closing the valve position and the sealing element 1207,1307 and 1407 provide sufficient clearance between the openings 1204,1304 and 1404 to avoid this. 例如,图62的肋1307,被充分布置得当阀关闭、打开或处于关闭和打开状态之间时避免与开口1304相接触。 For example, FIG ribs 130,762, and is properly disposed sufficiently close valve, is opened or closed to avoid the opening 1304 and the contact between the opened state. 通过以下更详细地描述的阀主体提供对这些密封元件的其他改良和描述。 Additional description of these improvements and the sealing element by the valve body described in more detail below.

图64到68中所示的阀组件还同时完成低压力流体密封、高压力流体密封以及防止微生物进入的复杂任务。 The valve assembly shown in FIGS. 64 to 68 also simultaneously completed in a low pressure fluid seal, and a high pressure fluid seal to prevent entry of microorganisms of complex tasks. 阀实施例1500需要两个部件,这两个部件一起形成流体阀系统。 Example 1500 requires two valve member embodiment, a fluid valve system with these two components. 第一部件为阀柱塞杆1502,第二部件为阀柱塞杆1502被容纳在其中的圆柱形主体开口1504。 The first valve member to the plunger rod 1502, a second valve member to the plunger rod 1502 is received in a cylindrical opening in which the body 1504. 整个流体阀系统被包含在流体容器中,因此可用于将液体形式的药物容纳在图1的输液装置100中。 The entire fluid valve system is contained in the fluid container, thus can be used to form a liquid medicament housed in the infusion device 100 in FIG. 1.

阀1500具有初始状态和启动状态,并且如图64到68中所示的分别包括径向突出毛刺或肋1506和1508的近端组和远端组。 Valve 1500 having an initial state and an active state, and as shown in 64 to 68 respectively include radially projecting burrs or ribs 1506 and 1508 of the proximal and distal groups groups. 在初始状态中,阀的近端肋1506形成密封以将药物安全地收集在容器(未示出)中,而远端肋1508用于防止微生物进入到流体路径1510中。 In the initial state, the proximal end of the valve sealing rib 1506 is formed so as to secure a drug in a collection vessel (not shown), while the distal end of the rib 1508 to prevent microorganisms from entering the fluid path 1510. 在长时间防止流体从容器的内部流失时以及在相同时间内防止药品从容器外部被污染时,肋1506组和肋1508组两者都执行关键的任务。 Upon prolonged prevent loss of fluid from the interior of the container and to prevent contamination of the drug from outside the container at the same time, the two groups of ribs and the rib 1506 1508 Group perform critical tasks.

在使用中,阀柱塞杆1502将最终通过按钮(未示出)的移动被推入到启动状态下并且肋1506和1508的功能改变以执行新职责。 And ribs 1506 and 1508 functions to change, in use, the plunger rod 1502 final valve (not shown) by moving the button is pushed into the starting state to perform the new functions. 当被推入时,近端肋1506组将前进到与容器流体连通的放大空腔1512中,这允许药品从容器中流出,越过近端肋1506并且进入阀流体路径1510。 When pushed, the proximal end of the rib 1506 will proceed to set an enlarged cavity in fluid communication with the container 1512, which allows the drug out of the reservoir, past the proximal end of the rib 1506 and the fluid path inlet valve 1510. 同时,远端肋1508组也被自然推入,并且肋1508本身的位置移动到这样一个位置,使得它们引导容器中的流体、通过阀流体路径1510从侧部口1514处流出、以及从最后流体路径(未示出)向下到患者针(未示出)。 Meanwhile, the distal end of the rib 1508 is naturally also pushed into the group, and the rib 1508 to position itself in such a position that they guide the fluid in the container 1510 flows out from the opening portion side of the fluid path through the valve 1514, and finally from the fluid path (not shown) downwardly to a patient needle (not shown).

由于远端肋1508组将流体从侧部口1514中引出,因此远端肋1508组现在必须起到高压密封的作用以确保流体正确地从适当侧部口1514中排出,而不是越过远端肋1508本身而漏出,这会导致流体流失。 Since the distal end of the rib 1508 to set the fluid drawn from the lateral opening portion 1514, the distal end of the rib 1508 thus set must now play the role of a high pressure seal to ensure correct fluid discharged from the appropriate side of the opening portion 1514, rather than beyond the distal end of the rib 1508 leak itself, which can lead to fluid loss. 为了确保成功地实现这一点,阀组件还可包含略呈锥形的圆柱形阀主体开口1504,其中阀柱塞杆1502如图65到68中所示的那样前进。 To ensure the successful implementation of this cylindrical valve body, the valve assembly may further comprise a slightly conical opening 1504, wherein the valve plunger rod 1502 as shown in FIG 65-68 shown in advance. 当处于图65到67中所示的初始状态或关闭状态中时,该锥形主体开口1504允许形成流体密封的远端肋1508安全地“获得设定”。 When the initial state shown in FIGS. 65 to 67 or the closed state, the tapered distal end of the body is formed an opening 1504 to allow fluid seal rib safely 1508 "was set." 也就是说,当处于关闭位置中时,阀柱塞杆1502的肋1508在圆柱形阀主体开口1504的内径范围内通常一直是放松的。 That is, when in the closed position, the valve 1502 of the rib 1508 of the plunger rod in the inner diameter of the cylindrical valve body opening generally has a range of 1504 to relax. 因此随着时间的流逝,当最终移动到打开位置中时,肋1508将丧失在主体上施加所需径向压力的某种能力。 Therefore, with the passage of time, when finally moved to the open position, the rib 1508 will lose some ability to exert a desired radial pressure on the body.

当远端肋1508用作阻碍微生物进入的屏障时,如图67中的箭头A所示的,该减小径向压力是可容许的,并且阀将仍然完全发挥作用。 When the distal end of the rib 1508 as a barrier hindering entry of microorganisms, indicated by arrow A in FIG. 67, the reduced radial pressure is tolerable, and the valve will remain fully functional. 然而如图68中所示的当远端肋1508向前移动并且它们的主要作用改变为克服箭头B的流动的高压密封而不是阻碍微生物进入的屏障时,要求远端径向肋1508最好用作流体密封。 However when the distal end 68 as shown in FIG rib 1508 is moved forward and their primary role is changed to the arrow B against the flow of the high pressure seal rather than hinder microorganisms from entering the barrier, the distal end of the requirements with preferably radial ribs 1508 as a fluid seal. 因此如果当关闭时远端肋1508已“获得设定”的话,那么如果它们在非锥形开口中前进的话当打开时它们不能有效地执行这项任务。 Thus if, when the distal end of the rib 1508 has been turned off "was set", then they are not effective if they perform this task proceeds in a non-tapered opening when it is opened. 因此,在图65到68中所示的实施例中,组件1500也具有圆锥形主体开口1504,从而当远端肋1508从初始状态朝向启动状态向前移动时,由于圆锥形主体开口1504具有减小的内径,因此它们将被“再次加压”,因此远端肋1508可有效地工作,而与阀1500关闭期间是否“获得设定”无关。 Thus, in the embodiment illustrated in FIGS. 65-68, the assembly also having a conical body 1500 opening 1504, the ribs 1508 such that when the distal end toward the start state is moved forward from the initial state, since the conical body having an opening 1504 Save smaller inner diameter, so that they will be "re-pressing", and therefore the distal end of the rib 1508 may operate effectively, and whether during closing valve 1500 "was set to" irrelevant.

具有圆锥形主体开口1504的优点在于,它仅通过单个模制部分实现了多重密封和流体流动目标。 A conical body having an opening 1504 advantage is that it is only a single molded part to achieve multiple objectives and fluid flow through the seal. 用在诸如该系统中的典型阀包含与阀柱塞杆结合使用的弹性密封、或塞,从而获得与图64和65中所示的实施例相同的密封特征。 A typical valve, such as the system comprises a valve used in conjunction with the plunger rod elastomeric seal or plug, thereby obtaining the same embodiment shown in FIGS. 64 and 65 seal characteristics. 也就是说,在图64和65中所示的实施例中,由于所用的阀柱塞杆1502是由刚性部分或元件与柔软的过度模制部分构成的(如下文中参照图69和72详细描述的),因此省却了密封或塞。 That is, in the embodiment shown in FIGS. 64 and 65, since (as the valve used in the plunger rod 1502 is made of rigid and flexible parts or elements overmolded sections 69 and 72 described in detail with reference to FIGS. ), and thus save the seal or plug. 由于图69和72的实施例通过更少的零件实现了所有要求的任务,因此由于减少了总零件数量显示出明显的成本节约,并且提供了简单的制造和装配程序。 Since the embodiment of FIG. 69 and 72 embodiment implements all required tasks through fewer parts, thus reducing the total number of parts since the show a significant cost savings, and provides a simple manufacturing and assembly procedures.

构成用于省却弹性塞的这样一种阀柱塞杆1502的一种方法是使用图69到74中所示的一/二注射模制程序。 Such a configuration of the plunger rod to dispense with the elastic valve plug 1502 is one method of one / two injection molding procedure shown in FIG 69-74. 在图69、70和71中,刚性聚乙烯元件1520被构成为阀1502的芯元件并且形成刚性结构,并且包括增大远端1521、用于随后支撑多个远端毛刺的主体1522、用于为流动路径提供间隙的减小直径主体1523、以及用于随后支撑多个近端毛刺的最低限度地增大的近端1524。 In FIGS. 69, 70 and 71, the rigid member 1520 is configured as polyethylene spool element 1502 and form a rigid structure, and includes an enlarged distal end 1521, a distal end for supporting a plurality of subsequent burr body 1522, for provide clearance for the flow path to reduce the diameter of the body 1523, and then minimally for supporting a plurality of enlarged proximal end of the proximal end 1524 of burrs. 图69示出了芯元件1520的透视图、图70示出了芯元件1520的侧视图、以及图71示出了芯元件1520的横截面图。 FIG 69 shows a perspective view of the core member 1520, FIG. 70 shows a side view of the core member 1520, and FIG. 71 shows a cross-sectional view of the core member 1520. 在示范性实施例中,增大远端1521具有大约为0.288英寸的直径和大约为0.030英寸的厚度。 In an exemplary embodiment, the distal end 1521 increasing with a diameter of about 0.288 inches and about 0.030 inches thick. 主体1522具有大约为0.099英寸的直径和位于端部1521和主体1523之间的大约为0.25英寸的长度。 Body 1522 having a diameter of about 0.099 inches at the ends and about 0.25 inches in length between 1521 and the body 1523. 减小直径主体具有大约为0.040英寸的直径和位于端部1524和主体1522之间的大约为0.023英寸的长度。 The body having a reduced diameter of approximately 0.040 inch in diameter and positioned between the end portions 1524 and the body 1522 is approximately 0.023 inches. 增大的近端1524具有大约为0.10英寸的直径和0.01英寸的厚度并且具有从其处沿轴向延伸的45°锥形端部。 Enlarged proximal end 1524 having a diameter of about 0.10 inches and 0.01 inches thick and having a 45 ° tapered end portion extending axially therefrom.

在图72、73和74中所示的第二注射模制程序中,弹性体过度模制部分1530被设在图69到71的芯元件1520上。 In the second injection molding procedure shown in FIGS. 72, 73 and 74, the overmolded elastomeric portion 1530 is provided on the core member 1520 of FIGS. 69-71. 图72示出了过度模制的芯元件1520的透视图、图73示出了过度模制的芯元件1520的侧视图、以及图74示出了过度模制的芯元件1520的横截面图。 FIG 72 shows a perspective view of the core element overmolded 1520, FIG. 73 shows a side view of the core element is molded over 1520, and FIG. 74 shows a cross-sectional view of the core element overmolded 1520. 所形成的阀元件或阀柱塞杆包括远端密封毛刺1531和近端密封毛刺1532,这提供了这样一个表面,所述表面可在阀开口中形成与独立塞所提供的相同密封。 A valve element or the valve formed by the plunger rod includes a distal seal the burr burr proximal seal 1531 and 1532, which provides such a surface, the surface may be formed in the same independent sealing plug is provided in the valve opening. 在这种情况下,所述阀省却了阀中独立橡胶塞或止动器的需要。 In this case, the valve obviating the need to separate the rubber valve plug or stopper. 在示范性实施例中,过度模制的远端毛刺1531具有大约为0.177英寸的直径和大约为0.016英寸的厚度。 In an exemplary embodiment, the distal end overmolded 1531 burr having a diameter of about 0.177 inches and about 0.016 inches thick. 过度模制的近端毛刺1532具有大约为0.114英寸的直径和0.02英寸的厚度并且具有从其处沿轴向延伸的45°锥形端部。 Overmolded proximal end 1532 has a burr of about 0.114 inches in diameter and 0.02 inches thick and having a 45 ° tapered end portion extending axially therefrom.

改良阀柱塞杆和开口仅是本发明实施例所提供的一个改良机构。 Improved valve opening and the plunger rod is merely a modified embodiment of the mechanism provided by the present invention. 在另一个改良阀实施例中,输液装置可使用旋转阀1535为输液装置提供流体连通。 In another embodiment the valve modified embodiment, the infusion device 1535 may be a rotary valve to provide fluid communication with an infusion device. 图75是旋转阀的侧视图、图76是处于使用前和使用中的旋转阀的横截面图。 FIG 75 is a side view of the rotary valve, FIG. 76 is a cross-sectional view of a rotary valve before use and used. 阀1535在路径1536和1537之间可具有简单的装设阀对齐部分,从而当阀如箭头A所示的那样转动时允许从容器(未示出)到针1538的流体连通。 Valve 1535 between 1536 and 1537 paths may have a simple installation of the valve alignment section, so as to allow fluid communication from the container (not shown) to the fluid when the needle 1538 is rotated as shown by an arrow A valve. 在图77、78和79中示出了另一个旋转阀实施例1540,具有截然不同的填充、注射和关闭位置或状态。 In FIGS. 77, 78 and 79 illustrate another embodiment 1540 of the rotary valve embodiments, having different filling, the injection and a closed position or state. 如图77到79中所示的,旋转阀可包括从臂1548处延伸并以可转动的方式装配在第二管1544中的第一管1542,并且通过杠杆臂1548将输液针1546附于第一管1542。 The rotary valve shown in FIG. 77 to 79 may include an extension 1548 from the arm and is rotatably fitted in the second tube to the first tube 1544 in 1542, and by the lever arm 1548 is attached to the first infusion needle 1546 a 1542. 每个管都包括多个用于对齐的开口以便于提供填充位置、关闭位置和注射位置,如下面更详细地描述的。 Each tube comprises a plurality of aligned openings in order to provide the filling position, a closed position and an injection position, as described in more detail below.

在填充位置中,如图79(a)中所示的,第二管1544中的填充开口1541与第一管1542中的填充开口1543对齐,从而通过第二管1544中的容器开口1554与容器流体连通。 In the filling position, as shown in (a), 79, 1544 the second tube with the first tube filling opening 1541 1542 1543 filling opening aligned with the container opening so that 1554 through 1544 in the second container tube fluid communication. 这仅允许填充开口1541与容器之间的流体连通。 This only allows fluid communication between the fill opening and the container 1541. 在图79(b)中所示的注射位置中,第一管1542中的填充开口1543被堵塞,并且第一管1542中的注射开口1552与第二管1544中的容器开口1554对齐。 In the injection position shown in (b) of FIG. 79, a first tube 1542 is blocked filling opening 1543, 1552 and the container 1544 and a second tube in a first tube 1542 injection openings 1554 align. 在图79(c)中所示的关闭位置中,第一管和第二管中的所有开口都被堵塞。 In the closed position shown in FIG. 79 (c) of the drawings, the second opening of the first tube and all tubes were plugged.

当装置被携带并且阀处于图79中的横截面图1550所示的关闭位置中时,流体通过第二管1544侧部中的孔1552进入但是第一管1542的侧壁使之停止。 When the apparatus is carried and the valve is in the closed position as shown in cross-sectional view 1550 of FIG. 79, the fluid tube 1544 through the aperture 1552 of the second side portion of the first tube into the sidewall 1542, but make it stop. 在该位置中,通过杠杆臂1548将输液针1546附于第一管1542,然而,针与第一管内部之间的流体路径与第二管1544的流体路径之间是封闭的,并且杠杆臂1548被布置在一定角度下以便于将针1546保持在使用者皮肤上方。 In this position, the lever arm 1548 through the infusion needle 1546 is attached to the first tube 1542, however, between a closed fluid path between the needle and the inside of the first tube and the second tube fluid path 1544, and the lever arm 1548 is disposed at an angle so as to remain above the skin of the user to the needle 1546.

当装置被启动时,杠杆臂1548旋转以使得针1546进入皮肤中。 When the device is activated, so that the lever arm 1548 is rotated to the needle 1546 into the skin. 该旋转使得第一管1542在第二管内部转动直到第一管1542中的侧部孔1554与第二管1544中的侧部孔1552对齐以允许流体流动。 Such that rotation of the first tube within the second tube 1542 is rotated until the aperture 1552 aligned with a first side portion of the side tube portion 1542 and the second hole 1554 of the tube 1544 to allow fluid to flow. 所述流体从第二管1544中的侧部孔1552中通过第一管1542中的侧部孔1554流入到第一管的中央以流到杠杆臂1548中的流体路径中、沿杠杆臂1548向下流动并且从针1546中流出进入到使用者皮肤中。 The fluid to the fluid path of the lever arm 1548 through the center hole of the first side portion 1554 of the tube 1542 into the first pipe from the second pipe portion 1544 in the lateral hole 1552, 1548 along the lever arm and flows out into the flow from the needle 1546 into the user's skin. 第一管1542中的侧部孔1554被布置得使其仅在针1546已进入到皮肤中期望深度时才打开流体路径。 A first side portion of the hole 1554 in the tube 1542 is arranged so that the needle 1546 is only entered when the desired depth into the skin to open the fluid path.

由于刚性杠杆臂1548用作流体路径,因此旋转阀实施例在阀与针之间不需要挠性流体路径。 Since the rigid lever arm 1548 serves as a fluid path, the rotary valve embodiments are not required the flexible fluid path between the valve and the needle. 另外,阀打开的时限直接与针在皮肤中的位置相关,从而排除了在针被适当地布置在皮肤中之前阀打开的可能性。 Further, the valve open time is directly related to the position of the needle in the skin, thereby eliminating the possibility of valve opening in the skin before being appropriately disposed in the needle.

通过组合打开阀的操作和在相同的操作和部分中插入针,图75到79中所示的实施例的流体路径和阀装配是简单的并且减少至更少的零件。 By combining the valve opening operation of the insertion needle and the same operation and in section, and the fluid path of the valve assembly of the embodiment shown in FIGS. 75 to 79 is reduced to a simple and fewer parts. 另外,管1542和1544无需为完整圆的,而是也可仅为圆弧的。 Further, tubes 1542 and 1544 need not be a complete circle, but may be merely the arc. 流体路径可为沿第一管1542的外侧向下的沟槽(未示出),所述沟槽与第二管1544上的孔1552对齐。 May be a fluid path along the outside of the first trench down tube 1542 (not shown), the groove 1552 aligned with the holes in the second tube 1544. 流体路径也可为沿第二管1544的内侧向下的沟槽(未示出),所述沟槽与第一管1542上的孔1554对齐。 Inside the fluid path may also be downwardly along the second groove 1544 tube (not shown), the groove 1554 is aligned with the holes in the first tube 1542. 流体路径也可由第二管1544内壁中的沟槽(未示出)和第一管1542的外壁构成。 A second fluid path may also be a groove in the inner wall of the tube 1544 (not shown) and the outer wall of the first tube 1542 configured. 在另一种变体中,杠杆臂1548可被附于旋转的外部(或第二)管1544,其中内部(或第一)管1542为固定的,以使得流体从第一管1542中流入到第二管1544。 In another variant, the lever arm 1548 can be attached to the rotation of the outer (or second) 1544 tube, wherein the inner (or first) pipe 1542 is fixed, so that the fluid flows from the first pipe 1542 to The second pipe 1544. 在每种变体中,阀类型为通过组合针插入的运动与打开流体路径的阀而对齐的孔和/或沟槽中的一个。 In each variant, the valve type is inserted through a combination of the movement of the needle valve is opened fluid path aligned holes and / or trenches a.

在图80和81中所示的另一个旋转阀实施例中,输液装置也可在容器沟道与患者针流体路径之间使用改良旋转阀机构。 Embodiment, the infusion device may also use the modified rotary valve mechanism between the container and the needle channel to another patient fluid path of the rotary valve shown in FIGS. 80 and 81 in the embodiment. 图80和81分别示出了关闭和打开位置中的阀组件。 FIGS. 80 and 81 show the closed and open position of the valve assembly. 在图80中,由于臂1559的旋转位置导致流体路径开口1557和1558没有对齐。 In FIG 80, since the rotational position of the arm 1559 causes the fluid path openings 1557 and 1558 are not aligned. 当臂1559沿箭头A的方向转动时,诸如当患者针被放置就位时,元件1556中的元件1555进入到图81中所示的位置中,流体路径开1557和1558变得对齐并允许流体流动。 When the arm 1559 rotates in the direction of arrow A, such as when the patient needle is placed in position, the element 1556 to element 1555 into the position shown in FIG. 81, the fluid path opening 1557 and 1558 become aligned and allow fluid flow.

参照图1,在用于向容器中施加基本均匀、恒定的力以便于从容器中压迫出内容物的装置100中包括盘状或贝式弹簧130,因此也称之为恒力弹簧。 Referring to FIG. 1, for applying a substantially uniform, constant force to the vessel to facilitate forced out of the container 100 from the contents of the device comprises a disk or Belleville spring 130, and therefore also known as a constant force spring. 如上所述的,恒力弹簧130用于储存能量,从而在使用时当通过激励装置使之放松时为容器加压。 As described above, the constant force spring 130 for storing energy, such that when the container is pressurized so as to relax by the excitation means in use. 在图1中,布置在多个贝式弹簧夹中心处的保持盘、柄或销135将贝式弹簧保持在弯曲状态下。 In Figure 1, the disc holder disposed in the center of the spring clip at a plurality of shell-type, or pin shank 135 will be maintained in a Belleville bent state. 在这种情况下,在储存期间防止贝式弹簧在容器150的膜151上或任何其余装置部件上施加压力。 In this case, the Belleville during storage to prevent application of pressure to the container 150 or film 151 on the device any remaining part.

当从贝式弹簧130上拉离保持销135时,弹簧夹被放松并且在容器150的膜盖151上施力。 When the slider 130 from the Belleville retaining pin 135 from the spring clip urging the membrane is relaxed and the cover 151 of container 150. 贝式弹簧130的边缘通常被限制在容器150的外圆周周围,并且为了进行容器内容物的皮内输送,贝式弹簧可被构成得最好在容器中产生大约1psi到50psi的压力,更好的是产生大约2到25psi的压力,最好的是产生大约15到20psi的压力。 Belleville edge 130 is generally limited around the outer circumference of the container 150 and transported to the skin of the container contents, it may be configured Belleville best to create a pressure of about 50psi 1psi in the container, a better It is to generate a pressure of from about 25psi to 2, most preferably about 15 to generate a pressure of 20psi. 为了进行皮下注射或输液,大约2到5psi范围内的压力可为足够的。 For subcutaneous injection or infusion, a pressure in the range of from about 2 to 5psi may be sufficient.

对于这些值来说,在治疗期间最好保持恒定或接近恒定的输液压力。 For these values, during the treatment is preferably maintained constant or near constant infusion pressure. 贝式弹簧机构130是提供所述接近恒定力的一种装置,所述力可转变为接近恒定的压力。 Belleville spring mechanism 130 is to provide an apparatus of the nearly constant force, the force may be converted to a near constant pressure. 如上所述的,为贝式弹簧加载的一种方法是使得弹簧夹偏斜并将销插入到所形成的开口的增大内径中。 As described above, a method for the Belleville spring loaded such that the spring clip is deflected and a pin inserted into an opening formed in the inner diameter increases. 为了返回到非偏斜位置,所述弹簧夹必须首先前进减小内径的距离,在销处于适当位置中时这是不可能的,从而将弹簧保持在加载位置中。 To return to the non-deflected position, the spring clip must first be reduced from the inner diameter of the proceeds, the pin is in the appropriate position it is not possible to hold the spring in the loaded position. 触发贝式弹簧是移除销的简单方法,但是由于贝式弹簧夹在销上导致了明显的摩擦载荷,因此即使在使用杠杆臂时,拉动所述销所需的力也是较大的。 Belleville trigger is a simple method of removing the pin, but due to the Belleville spring clip on the pin results in a significant frictional load, so even when the lever arm, the force required to pull the pin is larger. 如果在弹簧夹与销之间在杠杆臂上施加“力矩”的话,移除就变得较为容易了。 If applied to "torque" on the lever arm between the spring clip and the pin, then it becomes more easy to remove.

在图82中所示的改良实施例中,示出了包括多个弹簧夹1562、销1564、杠杆臂1566和支点1568的贝式弹簧1560。 In the modified embodiment shown in FIG. 82 embodiment, is shown comprising a plurality of spring clips 1562, pin 1564, 1566 of the lever arm and the fulcrum of Belleville 15,601,568. 当力被施加于杠杆臂1566的远端时,在贝式弹簧夹1562上在支点1568处诱发了反作用力。 When a force is applied to the distal end 1566 of the lever arm, the spring clip 1562 on Bayesian induces a reaction force at the fulcrum 1568. 进一步施加力将使得销1564转动直到其弹离贝式弹簧1560,如图83中所示的移除销1564。 Further application of force so that the pin 1564 will rotate until it bounces off the Belleville 1560, as shown in FIG removing pin 83 1564.

在图84(a)、84(b)和84(c)中示出了可使用该基本原理的几个(但非全部销1564)几何结构的取样,并且所述取样包括圆形销(a)、宽杆销(b)、以及窄杆销(c)以便于提供转动提升。 In FIGS. 84 (a), 84 (b) and 84 (c) shows a number (but not all pin 1564) sampling geometry can use this basic principle, and the sample comprises a cylindrical pin (a ), wide lever pin (B), and a narrow lever pin (c) in order to provide rotation of lift. 如结构(a)中所示的圆形几何结构允许放松力F1......Fn被施加在部分(a)外圆周周围的任何位置处,顶部或底部,如图85中所示的,以放松销84(a)。 The structure of (a) a circular geometry shown in the force F1 ...... Fn allows relaxation is applied (a) at any location around the outer circumference of the top or bottom section, as shown in FIG. 85 to release pins 84 (a). 结构(b)中所示的宽杆几何形状允许放松力被施加在部分的较窄外围上以放松如按钮通常所具有的销(b)。 Structure (b) the geometry of the rod shown in width allows to relax the force exerted on the peripheral portion to a relatively narrow relaxation generally has as a button pin (b). 结构(c)中所示的窄杆几何形状允许放松力从杆(c)的侧部而不是端部被施加。 Narrow rod illustrated geometry allows the relaxation force is applied from the side of the lever (c), instead of the structure of the end portion (c) of. 关于图84的结构(a),如图85中的力图所示的,在圆形销(a)的极端处施加放松力,导致更长的有效杠杆臂,从而降低所需力。 The configuration (a) of FIG. 84, as shown in FIG. 85 is sought, a round pin is applied at terminal (a) force relaxation, resulting in a longer effective lever arm, thereby reducing the force required.

可影响力被施加的位置的两个因素是装置的总高度和制造中装配的容易性。 Two factors may influence the applied position of the overall height and ease of assembly manufacturing apparatus. 在图86和87的横截面图中示出了施力和放松贝式弹簧的一种方法。 In the cross-sectional view of FIG. 86 and 87 illustrates a method of biasing spring and placed in Sumbe. 当处于其按钮被启动的输液装置中的位置中时,按钮1570通常如所示的被推向右部,并且斜坡1572通过杠杆臂1566在销1564上施力以便于从贝式弹簧1560上移除销1564。 When an infusion device in which the button is in the activated position, the button 1570 is pushed rightward portion generally as shown, and the ramp 1572 by urging the pin 1564 in the lever arm 1566 to move from the Belleville 1560 In addition to the pin 1564. 如图88和89中的透视图中所示的,可进一步减小所需拉出力的该改良实施例的另一种型式在销1564的外侧上提供了开口环1574。 As shown in perspective view in FIG. 88 and 89 in, another type can be further reduced according to this modified embodiment the force required to pull-out opening is provided on the outer ring 1574 of the pin 1564. 开口环1574必须具有低摩擦系数以便于可从开口环1574的内径中移除销1564,并且当如图89中所示的移除销1564时足以可损坏裂口间隙,以使得贝式弹簧1560被启动。 Split ring 1574 must have a low coefficient of friction so that the pin can be removed from the inner diameter of the opening 1564 of the ring 1574 and may be damaged when the vent FIG sufficient clearance to remove the pin 89 as shown in 1564 to 1560 is that the Belleville start up.

在以上每个实施例中,支点1568相对于销1564的中心线和高度的位置和高度对于功能都是关键性的。 In each of the above embodiments, the fulcrum 1568 is critical with respect to the center line of the pin 1564 and the height position and height for the function. 为了使得效率最大化,应如此布置和衡量支点1568以使得其可引发足够的销位移从而使得销1564扫除贝式弹簧1560,但是需要最小的放松力。 In order to maximize, and shall be so arranged to measure the efficiency of pivot 1568 so that it can lead to a sufficient displacement of the pin so that the pin 1564 remove 1560 Belleville, but requires minimal force relaxation. 将支点1568布置得离销1564的中心线更远将提供更大的销位移,但是增加了杠杆臂上用于移除销1564所需的放松力。 The pivot pins 1568 arranged away from center line 1564 would provide greater pin further displacement, but an increase of 1564 relaxation force required for removing the pin on the lever arm. 同样,将支点1568布置得离销1564的中心线更近将提供更小的销位移,但是减少了杠杆臂上用于移除销1564所需的放松力。 Similarly, the closer the fulcrum 1568 arranged to provide less displacement of the pin from the pin center line 1564, but reduces the relaxation force required to remove the pin for the lever arm 1564.

为了在某些应用中确保可靠的操作,尤其是在那些具有非常易弯的弹簧夹的应用中,所述机构必须被设计得使得支点跨越贝式弹簧的不只一个弹簧夹。 To ensure reliable operation in some applications, particularly in those applications where the spring clip has a very pliable, the mechanism must be designed such that not only across the fulcrum of a Belleville spring clip. 因此,从这一点来看,图84中的结构(a)和(b)比结构(c)更适合于这些应用。 Thus, from this point of view, the structure of FIG. 84 (a) and (b) ratio of the structure (c) is more suitable for these applications. 从概念上说,结构(c)将通过多个窄的、密集的弹簧夹操作,或者可将其构成得仅通过简单地加宽支点1568而工作。 Conceptually, the structure (c) 1568 operated by the plurality of narrow spring clip intensive operation, or it may be obtained simply by constituting a fulcrum widening. 如果贝式弹簧1560的不只一个弹簧夹在某种情况中未被跨越的话,那么相接触的单个弹簧夹就可能与其他弹簧夹无关地偏转并且在没有导致销相对于其他弹簧夹滑动的情况下沿销1564滑动导致弹簧放松失灵。 If the case of a Belleville spring clip 1560 by more than one in some cases are not crossed, then a single contact spring clip may be irrelevant to deflect the spring clip and the other does not result in the spring clip pin slidable relative to other pin 1564 slides along the malfunction causing the spring to relax.

图90到92示出了贝式弹簧1580的改良实施例,该贝式弹簧1580可与上述改良销放松机构结合使用并且取代贝式弹簧1560。 FIGS. 90-92 illustrate a Belleville 1580 modified embodiment, the Belleville 1580 may be used in combination with the above-described improved pin release mechanism 1560 and substituted Belleville. 改良贝式弹簧1580的尺寸通常为具有约1.15英寸到1.50英寸(最好为1.26英寸)的直径,并且可包括弹簧随动器1592以允许如上参照图55到60所述的基本全部容器内容物的输送。 Modified Belleville 1580 size is generally about 1.15 inches to 1.50 inches (preferably 1.26 inches) in diameter, and may include a spring follower as described above with reference to FIG 1592 to allow substantially all of the vessel contents to 55 60 delivery. 在下面所述的改良贝式弹簧1580中,贝式弹簧包括传统弹簧主体1581,以及过度模制的弹性体1582,所述弹性体1582覆盖主体1581并且填充弹簧夹之间的空隙,以使得当贝式弹簧1580在弯曲和放松位置之间前进时,弹簧在整个容器膜表面上施加基本均匀和恒定的力。 In the following the improved Belleville 1580, comprises a conventional Belleville spring body 1581, and the overmolded elastomer 1582, 1581 and the body 1582 to cover the gap between the elastomeric filled spring clip, such that when when Belleville 1580 proceeds between the bent and relaxed position, the spring exerts a substantially uniform and constant force over the entire film surface of the container. 过度模制的弹性体在不损害贝式弹簧性能的情况下填充在弹簧夹之间的“死角”中。 Overmolded in an elastomer without compromising the performance of Belleville filled in the "dead space" between the spring clip.

图90到92中示出的贝式弹簧改良实施例1580可作为主要流体腔加压机构。 90 to FIG. 92 Belleville modified embodiment illustrated embodiment the main fluid chamber 1580 may be used as the pressurizing mechanism. 上述输液装置通常包含这样的贝式弹簧,所述贝式弹簧适合于当可在流体填充腔上弯曲时在所述流体填充腔上施加所需的压力,之后,通过位移而排出所述流体填充腔中的流体。 Such devices typically include the transfusion of Belleville, the Belleville adapted to be bent when the fluid-filled chamber apply a desired pressure on the fluid-filled chamber, and thereafter, discharged by the displacement of the fluid-filled fluid in the cavity. 如图91和92中所示的,填充腔设计中固有的是填充腔1598的刚性侧以便于为填充腔1598提供结构,以及填充腔1598的挠性膜侧,所述挠性膜侧可变形以便于接收偏压到填充腔中的贝式弹簧的臂以便于排出填充腔中的流体。 Shown in FIG. 91 and 92, filling chamber is inherent in the design of the rigid side so as to fill the cavity 1598 to the flexible membrane provides a lateral structure, and filling the cavity to fill the cavity 1598 of 1598, the deformable flexible film side to bias the arm to receive the Belleville filled chamber so as to discharge fluid filled chamber. 尽管贝式弹簧和填充腔可适用于为填充腔加压并且输送流体,但是由于所述填充腔和贝式弹簧两者的刚性本质,贝式弹簧终究不能完全与填充腔1598的刚性侧的形状相一致。 Although Belleville filling chamber and adapted to transfer fluid is pressurized and filled chamber, but since the shape of the rigid nature of both the filling chamber and Belleville, Belleville ultimately can not be completely rigid side of the filling chamber 1598 consistent. 当弹簧在填充腔中“降至最低点”时,一致性的缺乏导致一些流体不会完全从填充腔中推出。 When the spring filling the cavity "bottoming out", lack of consistency leads to some of the fluid will not be completely out of the filling chamber. 所述流体损失是不可取的。 The fluid loss is not desirable.

本发明的改良贝式弹簧1580包括用于通过用弹性材料过度模制贝式弹簧1580而设法使得该流体损失到一定程度的组件,尤其是在贝式弹簧1580的弹簧夹之间,以使得弹性体允许贝式弹簧1580更完全地适应填充腔。 Modified Belleville 1580 by the present invention comprises an elastic material for Belleville 1580 and tried over-molding such that the fluid loss to a certain extent components, in particular between 1580 Belleville spring clip, so that the resilient Belleville body 1580 allows to adapt more fully fill the cavity. 当弹簧夹之间不再存在间隙时这使得贝式弹簧1580排出更多的流体,并且减少流体损失。 When the gap no longer exists between the spring clip 1580 Belleville This makes more fluid discharge and reduce fluid loss. 在图91和92中示出了过度模制贝式弹簧1580的所述使用的一个示例。 In FIGS. 91 and 92 shows one example of the overmolded Belleville 1580 used. 弹簧1580的弹性体填充区域1582在不损害性能的前提下填充弹簧夹之间的“死角”。 Filled elastomer filled region of the spring 1580 1582 "dead space" between the spring clip without sacrificing performance.

弹性体可被模制在整个贝式弹簧1580上,从而形成具有能够允许贝式弹簧1580既为填充腔加压,又完全与填充腔的轮廓一致以便于排出填充腔中的所有流体的柔顺面的弹簧。 The elastomer may be molded on the entire Belleville 1580, thereby forming a compliant surface all fluid filled cavity capable of allowing both a Belleville 1580 to fill the pressure chamber, and completely consistent with the contour of the cavity so as to discharge the filling having spring. 如容器横截面图91和92中所示的,贝式弹簧1590还包括过度模制弹性体随动器1592,与图55到60的随动器相似,但是用作贝式弹簧1590的过度模制表面。 The vessel cross-sectional view shown in FIG. 91 and 92, further comprising a Belleville 1590 overmolded elastomeric follower 1592, and FIGS. 55 to 60 is similar to the follower, but as a Belleville overmolded 1590 molding surface. 提供了随动器1592并且更适应于容器中的形状,尤其是填充腔1598的刚性侧,以使得在贝式弹簧1590前进时避开由随动器1592填充的死角。 Providing follower 1592 and more adapted to the shape of the container, in particular to fill the cavity 1598 of the rigid side, so that the avoiding filled with dead follower 1592 at Belleville 1590 proceeds.

邻近于贝式弹簧1590,挠性膜密封1594被设置得覆盖与刚性腔壁1598相对布置的流体袋1596。 Adjacent to the Belleville 1590, flexible membrane 1594 is provided so as to cover sealing the rigid chamber wall 1598 is disposed opposite the fluid pouch 1596. 如图91中所示的,当被放松时,贝式弹簧1590将内容物从填充腔中压迫出来。 As shown in FIG. 91, when relaxed, Belleville 1590 The contents in the filling chamber from compression. 在图91中所示的实施例中,弹簧1590通过用过度模制的弹性随动器1592“挤压”袋而完全排出袋中的流体。 In the embodiment shown in FIG. 91, the follower spring 1590 1592 "pressed" by the elastic overmolded with a fluid bag and the bag is completely discharged. 以上所述的所述弹性体覆盖贝式弹簧1590和弹性随动器1592的优点在于它增强了贝式弹簧作为“按压”的性能以确保完全抽空填充腔中的流体而不会损害其作为填充腔的加压器的性能。 The elastomer described above is covered elastic Belleville 1590 and 1592 with the advantages of the actuator is that it enhances the Belleville as "pressing" performance to ensure complete evacuation of fluid-filled cavity as a filling without compromising performance pressurizer chamber.

与贝式弹簧组件的使用相关的另一优点在于以生产的方式使用贝式弹簧所产生的摩擦的能力。 Another advantage associated with the use of a Belleville spring assembly in a manner that is produced using a Belleville friction generated capacity. 例如,如装置横截面图93中所示的,保持销1635与贝式弹簧1630之间的摩擦可用于将装置1600保持在非放松状态。 For example, as shown in a cross-sectional view of the device 93, the friction between the holding pin and the Belleville 1635 1630 1600 holding means may be used in a non-relaxed state. 如图93中所示的,示出了示例装置1600具有按钮设计,其中在单个多功能/步骤程序中实现装置1600的启动和激励。 As shown in FIG 93, illustrates an example apparatus 1600 has a button design, start-up and wherein the excitation implemented in a single multifunction apparatus 1600 / step program. 图93是使用侧部按钮1605被启动的示例片状注射器或输液系统的横截面图。 FIG 93 is a cross sectional view of an infusion system or the like injector side button 1605 is used to start.

图93的装置包括按钮1605、上部外壳1610、下部外壳1515、容器拉阀组件1620、贝式弹簧1630、弹簧保持销1635、歧管组件1625、以及容器1650。 FIG device 93 include buttons 1605, an upper housing 1610, lower housing 1515, to pull the container valve assemblies 1620, 1630 Belleville, spring retaining pin 1635, manifold assemblies 1625, 1650 and the container. 所述装置还包括挠性弹簧随动器1655。 The apparatus further comprises a flexible spring follower 1655. 所述装置还可包括具有覆盖物1617的粘合表面1616,所述覆盖物1617与针帽1618固定在一起以便于一步去除。 The apparatus may further comprise a cover having an adhesive surface 1617 of 1616, the cover 1617 with needle cover 1618 are held together to facilitate removal step. 在图93中所示的装置中,当按钮1605被推动时,以有序和/或同时的方式实现两项功能,而不是图1装置的三项功能。 In the apparatus shown in FIG. 93, when the button 1605 is pushed, ordered and / or simultaneous manner to achieve two functions, instead of three functions of the apparatus of FIG. 首先,按钮1605的移动打开用于容器1650与歧管1625的患者微型针1640之间的流体连通的拉阀1620。 First pull movement of the button 1605 to open fluid communication between the patient and the manifold container 1650 1625 1640 microneedle valve 1620 for communication. 如上所述的,所述阀1620可由任何数量的拉阀构成。 As described above, the valve 1620 may be any number of pull valve. 第二,按钮1605的移动移去了弹簧保持盘或销1635,放松贝式弹簧1630。 Moving the second button 1605 is removed or the spring retaining pin plate 1635, spring 1630 sombe discharge. 然而,销1635与弹簧1630之间的摩擦还用于将可转动的容器1650保持在收缩位置中。 However, the friction between the pin 1635 and the spring 1630 is further configured to be rotatable container 1650 in the retracted position. 当按钮放松贝式弹簧1630时,一个或多个歧管驱动弹簧1660使得容器1650关于铰链机构1652向下旋转,并且将针1640推动到患者皮肤中。 When the release button sombe spring 1630, one or more manifolds 1650 of the drive spring on the container 1660 such that the hinge mechanism 1652 is rotated downward, the needle 1640 and pushed into the patient's skin.

按钮1605具有渐缩表面1606,渐缩表面1606还包括沿渐缩表面1606的中心延伸并且销1635可从中穿过的狭缝1608(未示出)。 Button 1605 having a tapered surface 1606, 1606 further includes a tapered surface along the center of the tapered surface 1606 and pin 1635 which can extend through slits 1608 (not shown). 当压制按钮1605时,迫使有狭缝的渐缩表面1606行进得越过销1635,这迫使销1635到渐缩表面1606上并且远离弹簧1630。 When pressing the button 1605, forcing the slit tapered surfaces 1606 have crossed the pin 1635 travels, which forces the pin 1635 into the tapered surface 1606 and 1630 away from the spring. 按钮1605的移动还用于打开拉阀1620。 Move button 1605 is also used to pull open the valve 1620. 在足以打开拉阀1620的短距离之后,销1635被充分地提起以放松弹簧1630和容器1650。 After a short distance sufficient to open the valve 1620 to pull the pin 1635 is sufficiently lifted to loosen the spring 1630 and the container 1650.

具体地,在储存期间通过与弹簧1630的内部弹簧夹相抵触的销1635将贝式弹簧1630保持在张力下,并且阻止它们移动得更近(即,减小贝式弹簧中中央孔的内径)。 Specifically, during storage by the spring inside the spring clip 1630 to 1635 conflict Belleville pin 1630 is held under tension, and prevents (inner diameter Save i.e. formula Beckham spring center hole) thereof move closer . 当弹簧夹穿过中心时它们必须移动得更近以便于放松。 When the spring clip through the center thereof must be moved closer together in order to relax. 当其弯曲得穿过中央以保持弹簧1630的张力时,这允许一个销1635被布置在弹簧夹之间(即,贝式弹簧1630中的中央孔的内径)。 When it is bent to pass through the center of the tension spring 1630 to hold this allows for a pin is disposed between the spring clip 1635 (i.e., the inner diameter of the central hole Belleville 1630). 然而,所述装置必须还自动地插入输液微型针1640,所述微型针1640通过一个或多个独立驱动弹簧1660被附于容器。 However, the device must also be automatically inserted into the infusion microneedle 1640, the microneedle 1640 independently driven by one or more springs 1660 is attached to the container. 在装置1600被使用之前,这些驱动弹簧1660被压缩以便于储存,在使用装置1600时由于微型针1640被插入,因此整个容器1650与微型针1640一起移动。 Before the device 1600 is used, the drive spring 1660 is compressed for storage, since the micro-needle 1640 is inserted, the container 1650 so that the entire movement of the microneedle 1640 1600 together during use of the device.

在图93中所示的实施例中,销1635与贝式弹簧1630之间的摩擦用作将驱动弹簧1660保持在压缩状态下以及将装置1600保持在未启动状态下的方式。 In the embodiment shown in FIG. 93, as the friction between the pin 1635 of the drive Belleville spring 1630 in a compressed state 1660 and 1600 held manner in the non-activated state. 使用者通过按钮1605的移动从贝式弹簧1630上移除销1635而启动装置1600。 1600 is initiated by a user mobile device button 1605 is removed from the pin 1635 Belleville 1630. 销1635的移除不仅允许放松的贝式弹簧1630为容器1650加压,而且还放松容器1650和针1640以便于在驱动弹簧1660的力下向下旋转,并且所述移动足以将针1640插入到患者皮肤(未示出)中。 Not only allows removal of the pin 1635 Belleville 1630 relaxation pressurized container 1650, but also to relax the container 1650 and the needle 1640 so as to rotate downward under the force of the drive spring 1660, and the movement of the needle 1640 is inserted into sufficient skin of the patient (not shown). 销1635在贝式弹簧1630和驱动弹簧1660两者上保持张力,从而仅需要一次操作以在操作中设定两个完全不同的操作。 Pin 1635 maintain tension in both the Belleville springs 1630 and 1660 drive, so that only one operation required to set the operation in two different operations.

在其他装置中,使用者需要执行两个或多个不同步骤以实现容器的加压和患者针的放松。 In other devices, the user needs to perform two or more different steps to achieve relaxation and patient needle pressurized container. 其他装置具有通过使用者的一次推动执行两个步骤的按钮,但是需要更复杂的按钮组件以实现操作的正确时限。 Other devices having a correct time by pushing a button to perform two steps of the user, but require more complex button assembly to effect operation. 在图93中所示的实施例中,所述时限与装置相接合。 In the embodiment shown in FIG. 93, the timing and the engagement means. 这可通过利用贝式弹簧和销系统作为容器驱动弹簧放松机构、利用销1635上的贝式弹簧1630弹簧夹作为保持驱动弹簧上的压缩的方式而实现。 This mechanism can be driven by using the spring relaxation Belleville as a container and pin systems, the use of Belleville spring clip on the pin 16351630 manner as compression drive spring retaining achieved. 当从贝式弹簧1630上移除销1635时消除了摩擦,从而可允许驱动弹簧1660将针1640推入到患者中。 When removed from the Belleville 1630 when pin 1635 eliminates friction, whereby the drive spring 1660 may allow the needle 1640 is pushed into the patient.

如上所述的,贝式弹簧可在容器上弯曲以便于通过排放而排出容器中的流体。 As described above, the Belleville bendable in the container so that the fluid is discharged through the discharge vessel. 如上所述的,容器本身可包括刚性侧和挠性膜侧,所述挠性膜侧可变形以接收弹簧的臂。 As described above, the container itself may comprise rigid side and a flexible film side, the film side of the flexible deformable to receive spring arms. 然而,如下面更详细地描述的,可提供对于材料和结构技术方面的容器改进。 However, as described in more detail below, the container may be provided for structural materials and technical advances.

在典型输液装置中,容器通常是由具有强化学和/或抗药特性的材料制成的。 In a typical infusion, the containers are typically made of a material having reinforced learning and / or resistant characteristics. 这种材料通常不会与其他材料充分地粘接在一起。 Such materials are generally not sufficiently bonded with other materials. 图94到100中所示的本发明的改良容器实施例引进了至少一种其他材料,所述材料可与其他材料(诸如针)充分地粘接在一起,并且还包括用于将不可粘接的材料锁定于该新材料的装置。 94 to FIG improved container of the invention shown in Example 100, the introduction of the at least one other material that is sufficiently bonded together with other material (such as a needle), and further comprising a non-adhesive means for locking means of the material to a new material. 这将具有强抗药特性的不可粘接的材料(诸如容器1700)与可粘接材料(诸如图95的针头接口/弹簧臂1720)相分离。 Material (such as a container 1700) which will not be bonded with a strong resistant characteristics may be separated from the adhesive material (such as FIG needle hub / spring arm of 172,095). 之后这两个独立部分通过密封互锁(诸如图99和图100中所示的O形圈密封锁1730或弹性密封锁1740)彼此接合并作为一个整体发挥作用。 After these two separate parts by interlocking seal (O-ring 99 and density 100 shown in FIG., Such as 1730 or elastomeric seal lock block 1740) engage each other to function as a whole. 图94是容器的视图、图95是提供了流体路径的容器臂的视图。 FIG 94 is a view of the container, FIG 95 is a view of a container provides a fluid path of the arm. 图96是图95的容器臂的透视图。 FIG 96 is a perspective view of the container of FIG arm 95. 图97是图94和95的容器和臂的装配图,以及图98示出了装配的部件。 FIG 97 is a view of an assembled view of the container and the arms 94 and 95, and FIG 98 shows the components assembled.

本发明的改良容器实施例包括提供容器1700和容纳针头接口/弹簧臂1720的流体路径,每一个都由两个独立的模制部分构成。 Improved container of the invention to provide a container embodiment includes a fluid path 1700 and receiving a needle hub / spring arm 1720, each consisting of two separate molded parts. 图94、97和98的容器1700可由具有强化学和/或抗药特性的材料制成。 FIGS. 94, 97 and 170 098 of the container may be made of a material having a strong chemical and / or resistant characteristics. 针头接口/弹簧臂1720和所形成的图95、96、97和98的流体路径1724可由任何数量的塑料材料制成,并且沿阀排出孔1722和针开口1726之间的流体路径可包括单膜密封。 The needle hub / spring arm 1720 and fluid paths 98 95, 96 97, and 1724 may be formed of any number of plastic material, and the discharge hole 1722 along the needle valve opening and the fluid path between the membrane 1726 may comprise a single seal. 之后可通过图99和100中所示的适合的阀机构1730或1740将容器1700与针头接口/弹簧臂1720装配在一起。 After 99 and 100 by suitable valve mechanism shown in the container 1730 or 1740 1700 interfaces with the needle / spring arm 1720 assembled together. 图99和100示出了与图94到98的组件结合使用的第一和第二阀1730和1740。 99 and 100 illustrate the use of assembly 98 in conjunction with FIG. 94 to the first and second valves 1730 and 1740.

在典型输液装置中,容器和针头接口/弹簧臂的结构包括由一部分构成的容器和流体路径。 In a typical infusion device, the vessel and structure of the needle hub / spring arm comprises a container and a fluid path constituted by a part. 然而,如上所述的,容器1700需要由具有强化学和/或抗药特性的材料制成。 However, as described above, the container 1700 made of a material having required a strong chemical and / or resistant characteristics. 不幸的是,该材料不能与其他材料充分地粘接在一起(即,针)。 Unfortunately, the material is not sufficiently bonded together with other materials (i.e., needles). 分离如图94到97中所示的两个部分的优点在于,可更简单地将针1728装配于弹簧臂接口。 FIG advantages of separation of the two parts shown in 94 to 97 wherein, the needle may be more easily mounted on the spring arm 1728 interface. 它们可被插入模制或粘接,而不是机械地固定于不可粘接材料中。 They may be insert molded or glued, rather than mechanically fixed to the non-adhesive material.

在图99和100中示出了用于完成图98中的组件的密封锁示例。 And 100 in FIG. 99 shows an example of complete blockade of assembly 98 in FIG. 在图99中,阀柱塞杆1732被布置在弹簧臂/流体路径外壳1720中的圆柱形开口1734中。 In Figure 99, the valve 1732 is arranged in the plunger rod spring arm / fluid path in the cylindrical opening of the housing 1720 in 1734. 弹簧臂/流体路径外壳1720包括与容器1700中的开口1702相配的减小直径元件1736,并且由O形圈1738密封。 Spring arm / housing 1720 includes a fluid path and an opening of reduced diameter matching element 1702 1700 1736 containers, and sealed by O-rings 1738. 杆1732包括多个肋1733和增大近端1739,它起到与以上参照图5和图6所描述的那些基本相似的作用。 Lever 1732 comprises a plurality of ribs 1733 and proximal end 1739 is increased, it functions substantially similar to those effects 5 and 6 as described above with reference to FIG. 在图100中,O形圈1738由减小直径元件1746外表面周围的弹性外部密封1748取代。 In FIG. 100, O-ring 1738 is reduced by the resilient outer peripheral surface of the outer diameter 1746 of sealing member 1748 substituents. 其余阀功能基本如参照图99所述的。 The rest of the valve function substantially as described with reference to FIG 99.

在本发明的以下附加改良针头接口也包含不可粘接和可粘接材料接合的使用。 In the following additional modified needle hubs of the present invention may also comprise non-adhesive material and an adhesive is used the engagement. 该实施例使用二注射模制程序,所述模制程序具有使得两种或多种不同本质的热塑性塑料形成流体密封的能力。 This embodiment uses two injection molding procedure, so that the molding procedure having two or more different thermoplastics formed essentially fluid-tight capabilities. 由于考虑到所述材料是不同的,因此它们固然不会粘接在一起。 Taking into account the materials are different, although they are not so bonded together. 在正常二注射模制程序中,通常通过待使用的塑料的粘合特性形成密封。 In the normal two injection molding process, is generally formed by bonding the sealing characteristics of plastic to be used. 在下面所述的改良接口实施例的情况中,在塑料之间不存在粘合特性,从而利用多个独特设计形成压配合,因此形成流体密封。 In the case of the embodiment described below an improved interface, the adhesive properties between the plastic does not exist, thereby forming a plurality of unique design using a press fit, thus forming a fluid seal.

在图101中,示出了完全粘接部分1750的横截面图,并且粘接部分1750包括流体路径1752、膜密封1754以及第一注射模具1760。 In Fig. 101 shows a cross-sectional view of the fully bonded portion 1750, and the bonded portion 1750 includes a fluid path 1752, 1754, and sealing membrane 1760 the first injection mold. 之后将第二注射模具1758设置在第一注射模具1760周围并且固定针头1756。 After the second injection mold 1758 is provided around the first fixed needle injection mold 1760 and 1756. 如图101中所示的,第一注射模具1760被模制得具有突出的鸠尾状形状,从而当第二注射模具在每个鸠尾形状周围冷却并收缩时提供与第二注射模具1758之间的机械锁定。 , First injection molding die 1760 is projected to have a dovetail-like shape, thereby providing an injection mold when the second and shrinks around each shape with a dovetail cooled second injection mold 101 as shown in 1758 of FIG. between mechanical locking.

具体地,在适当地冷却和标准多注射模制程序之后,用具有期望处理特征的材料(诸如聚碳酸酯)制成第二注射模具1758。 Specifically, after appropriate cooling and standard multi-injection molding process, a second injection mold 1758 is made of a material (such as polycarbonate) having a desired process characteristics. 在这种情况下,用透明的塑料材料制成第一注射模具1760。 In this case, transparent plastic material of the first injection mold 1760. 透明的塑料材料最好为循环烯烃共聚物(CCP),所述循环烯烃共聚物的特征在于,具有高透明性和清晰性、与容纳在容器中的物质之间的低可提取性以及生物相容性。 Transparent plastics material is preferably a cyclic olefin copolymer (-CCP), a cyclic olefin copolymer characterized by having a high transparency and clarity, low extractables and receiving between the container and the biological material with capacitive. 该材料不能自然粘接于诸如聚碳酸酯等另一种材料。 The material is not naturally bonded to another material such as polycarbonate.

作为完全模制组件1751、1753、1755和1757的横截面图的图102到105中所示的CCP第一注射模具的几何结构可包括任何数量的鸠尾形状和锁定结构。 As a cross-sectional view of the molding assembly completely 1751,1753,1755 and 1757 of FIG CCP geometry shown in the first injection mold 102-105 may include any number and shape of a dovetail lock. 在每种情况中,在第一注射模具的适当冷却之后,用诸如聚碳酸酯的材料制成第二注射模具,并且将其注入到鸠尾形状周围以使得它们可包围每个鸠尾形状。 In each case, after a suitable cooling of the first injection mold, made of a material such as polycarbonate, a second injection mold, and injected around the dovetail shaped such that they can surround each dovetail shape. 当第二注射模具收缩时,正如所有塑料收缩到一定程度时,其将在鸠尾形状的倾斜表面上施加压力并且具有“夹住”鸠尾形状的作用。 When the second injection mold shrinkage, as when all plastic shrink to a certain extent, it will exert a pressure on the inclined surface a dovetail shape and has the effect of "sandwiching" a dovetail shape. 该夹住在两种不同材料之间形成了紧密的流体密封,若非这样在所述不同材料之间就不能形成流体密封。 The sandwich is formed of a fluid tight seal between two different materials, if not so can not form a fluid seal between the different materials.

以上所述的本发明的改良实施例还能够在一个部分中在两种不同的材料类型(即,1760和1758)上形成连续的流体路径。 Development of the invention according to the above embodiment can also be in one part of the two different types of materials (i.e., 1760 and 1758) forms a continuous fluid path. 这减少了部件数量从而降低了成本,否则的话必须使用搭扣配合和(可能还需要)密封元件(诸如O形圈)形成连续的流体路径。 This reduces the number of parts thereby reducing cost, it must be used otherwise and snap-fit ​​(possibly needed) a sealing member (such as an O-ring) to form a continuous fluid path. 这不仅会由于部件数量的增加而导致增加成本,并且还增加了制造复杂性。 This is not only due to the increased number of components and the cost is increased, and also increases manufacturing complexity. 另外,所述结构可取得两种或多种不同材料的期望特征并减少损害的优点,否则如果仅用一种或另一种材料形成所述结构的话可能会造成所述损害。 Further, the structure may be made of two or more different materials desirable features and advantages of reducing the damage, or if only one or the other material, then the structure may cause the damage.

例如,通过用诸如CCP的材料模制第一注射模具(即,1760),本实施例可利用所述材料的有利药物携带能力。 For example, by using a material such as CCP first injection molding mold (i.e., 1760), the present embodiment may utilize the drug advantageously carrying capacity of the material. 不幸的是,事实上所述材料没有显示出任何其他通用的、积极的制造或处理特征。 Unfortunately, the fact that the material does not exhibit any other generic, positive manufacture or handling characteristics. 例如,CCP难以与针粘接在一起。 For example, CCP poor adhesion with the needle. 因此,第二注射模具(即,1758)可用诸如聚碳酸酯的材料制成,针易于粘接于聚碳酸酯,并且还不会对容纳于由CCP制成的部分中的药物造成不利影响。 Thus, the second injection mold (i.e., 1758) is made of a material such as polycarbonate can be used, the needle easily adhered to the polycarbonate, and the drug moiety is not to be received by the CCP made in adverse effects.

应该理解的是,可通过各种方式实现在两个略微不同的材料之间形成流体密封的该原理。 It should be appreciated that this principle can be implemented in the form a fluid seal between two slightly different materials in various ways. 根本原理是以这样一种方式在第二材料的表面上渠化或治理一种材料的收缩,所述方式即,在所述材料之间引起紧密的压力感应密封。 Underlying principle in such a manner on the surface of the second material canal treatment or shrinkage of one material, i.e. the way, causing a tight seal between the pressure sensitive material. 在本发明改良特征的实施例中通过使用鸠尾形状概念的变体实现了这一点。 In an embodiment of the present invention features improved by using variations of the concept of a dovetail shape to achieve this. 如图103到105中所示的,在改进锁定中,在竖直和垂直表面上的收缩也可用于形成充分的流体密封。 FIG 103-105 shown in improving the locking in the vertical shrink and vertical surfaces can also be used to form a substantially fluid-tight seal.

所述概念可被进一步改进为包括对于高容积模制、装配和自动程序的改良。 The concept may be further modified to include improvements for high volume molding, assembly and automated procedure. 鸠尾形状布置代表以各种方式在早期概念上的改进,包括模制程序的简化以及使用热塑性塑料模制操作中的收缩以在不同材料之间形成压力密封。 Representative disposed dovetail shape in the early conceptual modified in various ways, including simplifying the molding process and shrinkage of the thermoplastic used in the plastic molding operation to form a pressure seal between the different materials. 在下面更详细地描述的改良接口实施例中进一步发展了与患者针粘接在一起的能力。 Further development of the embodiment with the needle bonding ability together with improved patient interface described in more detail in the Examples.

以上所述的输液装置的每个实施例都包含至少一个或多个患者针,或微型针。 Each embodiment of the infusion device according to the above containing at least one or more patient needles or microneedles. 每个微型针最好至少为31规格或更小,诸如为34规格,并且被固定在患者针歧管中并可用于标定具体应用所需的真皮或皮下空间。 Each micro-needle is preferably at least 31 gauge or smaller, such as a size 34, and is fixed to the patient needle manifold can be used for calibration of the particular application desired dermis or subcutaneous space.

患者针被布置在患者针歧管中,每个患者针具有至少一个流体连通路径。 Patient needle is disposed in the patient needle manifold each having at least one patient needle fluid communication path. 歧管可仅具有用于一个或多个患者针的一个路径,或者可提供分别向每个针输送内容物的多个流体路径。 The manifold may have a path for one or more patient needles only, or may be provided separately conveying the contents of the plurality of fluid paths to each needle. 在图106中所示的改良的实施例中,形成有迷你型针头接口1770以便于固定针1772,之后将其搭扣配合于相应的针歧管1771中。 In the modified embodiment 106 shown in FIG embodiment, the needle hub is formed with a mini fixed to the needle 1772 to 1770, after which a snap-fit ​​in corresponding needle manifold 1771.

在微小输液装置中,药物容器通常具有适合于将药物储存并保持在液体形式下的属性。 In the minute infusion, the drug container having a generally suitable for the drug reservoir and maintained in a liquid form attribute. 然而,由于药物储存属性导致相同的容器具有不适合于形成坚固药物输送装置所需的外围制造程序的特征。 However, since the properties of the drug reservoir container having the same cause are not suitable for forming solid pharmaceutical manufacturing process required for a peripheral device delivery characteristics. 尽管最好使得流体容器与最终将药物输送给患者的针之间具有直接连通,但是用于储存药物的热塑性塑料不易于与其他材料粘接在一起。 Although it is preferable that the fluid container and finally delivering a drug to a patient having a direct communication between the needle, but medicament for thermoplastics easily stored together with other materials in the adhesive. 因此,如上所述的,几乎不可能将针粘在相同的容器材料上并且形成期望的流体路径而不会出现由于缺乏强粘接而导致的针可能掉落。 Thus, as described above, it is almost impossible to stick the needle in the container on the same material and form the desired fluid path does not occur due to lack of the bonding strength caused by the needle may fall.

图106中所示的本发明的改良接口实施例通过作为独立部分隔离容器的针头接口部分1770而解决了该问题。 Interface improved embodiment of the present invention shown in Fig. 106 as illustrated by the isolation container separate needle portion interface portion 1770 solves this problem. 这样,所分离的接口1770可被构成得适当地发挥作用(即,用作固定的针歧管),可作为药物容器(即,作为生物相容性容器)(未示出)。 Thus, the interface 1770 can be separate configured to be functioning properly (i.e., the needle used as a fixed manifold), as the drug container (i.e., as the biocompatible container) (not shown). 不幸的是,当一个复杂部分被构成为两个更简单的部分时,由于工具、处理、储存(即,备料保存单元或SKUs)等方面的增加,这实际上增加了总成本。 Unfortunately, when a complex part is configured as two portions simpler, due to the increased aspect tools, processing, storage (i.e., preparation or storage unit SKUs) and the like, which actually increases the overall cost. 然而,由于其简单的制造属性,图106中所示的改良实施例可长期节约资源。 However, due to its simple manufacturing properties, improved embodiment 106 shown in FIG embodiment may be a long-term conservation of resources.

可在高空化作用下在标准的简单模制工具中模制接口1770。 It may be at high altitude in standards of simple molding the molding tool interfaces 1770. 可在高速下自动进行模制并且可用适合于与针(诸如针1772)粘接在一起的材料模制所述接口1770。 Can be molded at high speeds and may be automatically adapted to the needle (such as a needle 1772) together with an adhesive material molding said interface 1770. 由于定位要求所述接口1770也不涉及大量处理,并且可通过渐缩表面1773所提供的搭扣配合机械地附于歧管1771,省却成本高的材料和程序。 Since the positioning in claim Interface 1770 does not involve a lot of processing, and by a tapered surface may be provided with fastener 1773 is mechanically attached to the manifold 1771, to dispense with costly materials and procedures. 另外,在实际将接口1770插入到歧管1771中之前,本实施例可进行简单的流体路径连续性测试。 Further, prior to the actual interface 1770 is inserted into the manifold 1771, the present embodiment may be a simple fluid path continuity test.

如上所述的,装置的微型针可具有不同的长度或规格,并且沿主体长度、针尖或针斜面可包含一个或多个孔。 As described above, the microneedle device may have a different length or specifications, and along the length of the body, or bevel of the needle tip may comprise one or more apertures. 当这样的微型针用于输送药物时,它们可由于多种原因而堵塞。 When such microneedles for delivering the drug, which may be blocked for various reasons. 在本发明的另一个改良针实施例中,提供了一种微型针,所述微型针可在尽管可能堵塞的情况下进行药物的输送。 In another embodiment of the present invention improved needle embodiment, there is provided a microneedle, the microneedles may be in the drug delivery although the situation may be clogged.

在图107中的针侧视图中示出了改进实施例的第一变体,其中通过沿针主体的至少一部分使用多孔材料、在针的内部与外部之间提供期望程度的流体连通构成了针1811。 In the side view of the needle 107 is shown an improved embodiment of the first variant embodiment, in which the needle body along at least a portion of the porous material is used to provide the desired degree of fluid between the interior and exterior of the needle constitutes a communicating needle 1811. 因此如果针1811的针尖被堵塞的话,依然可通过多孔材料发生流动。 Therefore, if the needle tip 1811 is blocked, then the flow can still occur through the porous material. 在图108中示出了改进实施例的第二变体,其中除主排出孔1819以外,针1813沿针主体的至少一部分(最好在针1813的针尖周围)使用多个微孔1817。 In FIG 108 shows a modified embodiment of the second variant embodiment, which in addition to the main discharge orifice 1819, 1813 along at least a portion of the needle body of the needle (preferably around the needle tip 1813) 1817 using a plurality of micropores. 如果针尖被堵塞的话,这允许通过微孔1817流动。 If the needle tip is blocked, then this allows the flow through the micropores 1817. 通过在结构中使用多孔材料或者通过随后增加孔可获得每个变体。 By using the structure or the porous material obtained in each variant by subsequent increasing hole.

针的改良、贝式弹簧的改良以及材料用法的改良也可应用在如下面更详细地描述的具有启动改良的装置中。 Improved needle, Belleville modified and improved material usage can also be applied in an apparatus having an improved promoter as described below in more detail. 在图109和110中所示的另一个装置改良中,在一个多功能/步骤程序中执行装置的改良启动和激励,并且使用枢轴臂2770精确地控制时限以同时接近容器和患者皮肤表面。 In a further modified apparatus shown in FIGS. 109 and 110, perform the improved startup and energizing means in a function / procedure step, and the pivot arm 2770 used to accurately control the timing to close the container and the surface of the skin while the patient. 图109是处于未启动状态下所述片状注射器或输液系统的第一实施例的横截面图,图110是处于启动状态下所示的实施例的横截面图。 109 is a cross-sectional view of a first embodiment of the sheet-like syringe or an infusion system of the non-activated state, FIG. 110 is a cross-sectional view of the embodiment shown in the activated state.

图109的装置包括上部和下部外壳(未示出),容器隔膜组件2740、患者针歧管组件2750、以及容器2760。 FIG apparatus 109 includes upper and lower housing (not shown), the container diaphragm assembly 2740, the patient needle manifold assembly 2750, and a container 2760. 还提供了在歧管2750和阀针2780之间延伸的枢轴臂2770。 Pivot arms are also provided between the manifold and the valve pin 2780 2750 2770 extends. 示出了启动机构2790,所述启动机构2790可由任何数量的装置(诸如图1的按钮)构成。 2790 shows a start mechanism, the activation of any number of means (such as a button of FIG. 1) mechanism 2790 may be configured.

在图109和110中所示的实施例中,当装置启动时,以顺序和/或同时的方式实现了两项功能。 In the embodiment illustrated in FIGS. 109 and 110, when the device is activated, the order and / or simultaneous manner to achieve the two functions. 第一,启动机构2790放松歧管2750,所述歧管2750随后由一个或多个歧管弹簧2795驱动,使得枢轴臂2770关于枢轴2775转动。 First, start the relaxation mechanism 2790 2750 2795 followed by one or more drive springs manifold manifold 2750, the manifold 2770 such that the pivot arm 2775 rotates about the pivot. 第二,旋转的枢轴臂2770将患者针歧管2750布置在患者皮肤2751上,并且还将阀针2780驱动到容器隔膜2740中。 Second, rotating the pivot arm 2770 to 2750 patient needle manifold 2751 is disposed on the skin of the patient, and also to drive the valve needle separator vessel 2740 2780. 在这种情况下,旋转的枢轴臂用作容器2760与患者针歧管2750之间的流体连通路径。 In this case, the rotation of the pivot arm 2760 as the container 2750 in fluid communication path between the tube and the patient needle manifold. 因此本实施例通过单次操作(诸如装置按钮(未示出)的简单推动)将微型针刺入到患者皮肤2751中并且打开阀将药物全部注入,并且还提供了流体在容器和患者之间的传输。 Thus the present embodiment, by a single operation (such as a simple push button means (not shown)) A 2751 micro-needle into the skin of the patient and all of the drug injection valve is opened, and also provides a fluid between the container and the patient transmission.

图109和110中所示的改良实施例包括枢轴臂2779或管,所述枢轴臂2779在一端处在直角下包含多个注射针2753,并且在另一端处包含指向相对方向的一个阀针2780。 FIGS. 109 and 110 modified as shown in the embodiment comprises a tube or the pivot arm 2779, one end of said pivot arm 2779 comprises a right angle at the plurality of injection needles 2753, and comprises a valve pointing in opposite directions at the other end needle 2780. 枢轴臂2770的管在两端之间具有枢轴点2775,这使得输液针2753具有刺入患者皮肤2751所需的一定移动范围,同时还使得阀针2780刺入引入到容器2760中的容器隔膜组件2740。 The pivot arm 2770 has a pivot point of the tube 2775 between the ends, so that the infusion needle 2753 having a certain range of movement required for puncturing skin of a patient 2751, while still allowing the needle 2780 penetration into the vessel of the container 2760 diaphragm assembly 2740. 通过一个或多个弹簧2795进行枢转操作,并且通过启动机构2790被保持在装备位置中。 Pivoting operated by one or more springs 2795 and 2790 is held in position by actuating mechanism equipped.

如图110中所示的,当启动机构2790被启动时,弹簧2795开始使得枢轴臂2770的管关于枢轴点2775旋转。 As shown in FIG 110, when the actuation mechanism 2790 is actuated, the spring 2795 so that the pivot arm 2770 begins tube 2775 is rotatable about a pivot point. 当枢轴臂2770的管旋转时,具有输液器针歧管2750的管的端部向下移动,将针2753推入到患者皮肤2751中。 When the tube is rotated pivot arm 2770 having an infusion needle manifold tube ends of the tube 2750 is moved downward, the needle 2753 is pushed into the skin of the patient in 2751. 枢轴臂2770的管的另一端向上移动,将阀针2780推动得穿过隔膜2740。 The other end of the pivot arm 2770 upward movement of the tube, will have to push the needle through the septum 2780 2740. 当阀针2780刺入隔膜2740的远侧时,药物从容器2760中被释放并且穿过阀针2780,沿枢轴臂2770的管向下,并且从歧管2750的输液针2753中排出进入到患者体内。 When the distal septum piercing needle 2780 2740, and the drug is released through the valve pin 2780, 2770 of the pivot arm along the tube downwardly from the container 2760, and the infusion needle from the manifold 27532750 discharged into the the patient. 由于在启动机构2790被推动之前或与之同时使用以上所述的任何一种加压技术为容器2760加压,因此药物将流动。 Because no single technique before starting the pressing mechanism 2790 is pushed or simultaneously using the above-described container 2760 is a pressurized, medicament will thus flow.

与传统装置相比较,本发明的该改良启动实施例是更简单的装置并且包含减少数量的零件,因此易于装配。 Compared with the conventional apparatus, the modified embodiment of the present invention is to start a more simple means and containing a reduced number of parts, and therefore easy to assemble. 例如,在传统装置中,输液针和阀针彼此垂直地移动并且通常通过管连接。 For example, in the conventional apparatus, the valve needle and the infusion needle to each other and generally perpendicular to the pipe connection. 该改良实施例用一个连续刚性旋转零件2770构成的一个移动零件取代了其他实施例中常用的流体路径中的三个移动零件(即,在直角下滑动的两个零件以及一个挠性零件)。 This modified embodiment using a continuous rigid mobile part a rotating part 2770 composed of the three other substituents common fluid path moving parts in the embodiment Examples (i.e., at right angles to the sliding parts, and a flexible part two). 用更易于装配的刚性零件取代了可能难于装配的挠性管。 Easier to assemble with the rigid component may be difficult to replace the flexible tube assembly.

在图111到115中所示的另一个改良启动实施例中,所述装置可使用磁体的吸引力或排斥力在流体上施力并且通过流体路径驱动流体。 In FIGS. 111 to 115 shown in another modified embodiment startup, the device may use magnets attractive or repulsive force and the fluid force on the actuating fluid through the fluid path. 这些实施例也可用于磁力地施加将针推入到皮肤中所需的力。 These embodiments may also be used to apply a magnetic force to push the needle into the skin, the force required. 系统内部的磁体的势能不会随时间的推移而消散,并且可将磁体充分地隔离开以减小它们彼此之间的吸引力以及施加在用于容纳它们的聚合体上的力,从而减少蠕变。 Potential inside the magnet system is not dissipated over time, and may be isolated from the magnet sufficiently to reduce the attraction between each other and for receiving a force thereof is applied to the polymer, thereby reducing the creep change. 可根据使得所述机构最优化所需的强度调节磁体分离距离和强度。 Magnet separation distance may be adjusted according to the intensity and that the means to optimize the required strength.

如图111的横截面装置图中所示的,装置1800具有上部外壳1805、下部外壳1810、膜覆盖的流体容器1815、流体路径1820、以及启动机构1825。 As shown in a cross-sectional view of FIG apparatus 111, the apparatus 1800 has an upper housing 1805, lower housing 1810, the fluid film covering the container 1815, the fluid path 1820, and the activation mechanism 1825. 当被启动(即,通过按钮或相似装置使得机构1825移动,摆脱磁体1805)时,各个磁性上部和下部外壳1805和1810的吸引力一起将容器1815中的内容物通过流体路径1820压迫出,并且经由针1822进入患者体内。 When activated (i.e., button or similar means such that the movement mechanism 1825, 1805 out of the magnet), the respective magnetic attraction of the upper and lower housing 1805 and 1810 with the contents of the container 1815 1820 forced out through the fluid path, and 1822 through the needle into the patient. 在图112的横截面装置图中,第一和第二磁体的排斥力用于从布置在所接合的磁体上方的容器中压迫出内容物。 In a cross-sectional view of the device 112, the first and second magnets is a repulsive force for pressing out the contents from the container disposed above the magnet in engagement.

如图112中所示的,透明覆盖的流体腔1830被布置在与上部磁体1840(在该示例中,N极在上S极在下)相接合的活塞1835的上方。 Shown in FIG. 112, the transparent cover 1830 fluid chamber above the piston 1835 is engaged with the upper magnet 1840 (in this example, N pole on the lower S pole) arranged. 当被启动时,上部磁体被下部磁体1845排斥(在该示例中,S极在上N极在下),迫使活塞1835进入到腔室1830的内容物中。 When activated, the lower portion of the upper magnet is repelled magnet 1845 (in this example, S pole on the lower N pole), forcing the piston 1835 into the chamber 1830 of the contents. 内容物通过开口1850(如上所述的,所述开口可装配阀)被压迫出并且被压迫到歧管1855中。 Contents through the opening 1850 (as described above, the valve opening can be assembled) and is forced out of the manifold pressure to 1855. 歧管可由具有低阻力的材料(诸如聚丙烯或聚乙烯)构成以便于当由歧管弹簧1860驱动时移动。 The manifold may be a material having a low resistance (such as polypropylene or polyethylene) configured to facilitate movement of the spring 1860, when driven by the manifold.

在图113的装置横截面图中所示的另一个启动改良实施例中,装置包括上部外壳1865、下部外壳1870、流体容器1875(透明流体腔)、流体路径1880、以及上部和下部磁体1882和1884。 Another improvement shown in the start cross-sectional view of the apparatus 113 in the embodiment, the apparatus includes an upper housing 1865, lower housing 1870, fluid reservoir 1875 (clear fluid chamber), the fluid path 1880, and upper and lower magnet 1882 and 1884. 可用钢板(未示出)取代磁体1882或1884,这也能获得所需的吸引力。 Available plate (not shown) or a substituted magnet 1882 1884, which can be obtained the desired appeal. 当被启动时(即,通过按钮或相似装置),上部和下部磁体1882和1884的吸引力或磁体和钢板的吸引力一起将容器1815中的内容物通过流体路径1880压迫出,并且经由针1881进入患者体内。 When activated (i.e., button or similar means), the upper and lower magnetic attraction or magnetic attraction and the steel sheet 1882 and 1884 with the contents of the container 1815 1880 forced out through the fluid path 1881 via a needle into the patient. 包含以上所述任何数量机构的中央喷射患者针机构可用于在启动期间安放患者针1881并且导致死角的最小化。 Central injection patient needle mechanism comprising the above-described mechanism may be used in any number of patient needle placement during startup and results in 1881 to minimize dead space.

在使用前和使用之后侧视图114和115中所示的另一个启动改良实施例中,所述装置包括具有多个针1894的磁性上部外壳1890和具有多个开口(未示出)的磁性下部外壳1892,所述开口与针1894同心并且每个开口都具有足以使得每个针1894穿过的直径。 Before and after the use side 114 and 115 shown in another modified embodiment of the startup, said device comprising a lower magnetic upper housing 1894 having a plurality of openings 1890 and magnetic (not shown) having a plurality of pins a housing 1892, a needle 1894 is concentric with said opening and each opening having a diameter sufficient to allow each needle 1894 therethrough. 同样也可用钢板(未示出)取代磁体1890或1892,这也能获得所需的吸引力。 The steel sheet is also available (not shown) or a substituted magnet 1890 1892, which can be obtained the desired appeal. 当使用机构1896被启动时(即,通过按钮或相似装置位移),上部和下部磁体1890和1892的吸引力或磁体和钢板的吸引力压迫针1894通过下部外壳1892的开口,并且进入患者的皮肤表面1895,如图115中所示的。 When using the mechanism 1896 is activated (i.e., button or similar means of displacement), the upper and lower magnets 1890 and 1892 and the attraction plate or magnet attraction compression needle 1894 through the lower housing opening 1892, and into the skin of the patient surface 1895, as shown in FIG 115.

上述每个装置都用于通过片状装置输送物质。 Each of said means are means for conveying the sheet material through. 在布置在使用者身上并被启动之后,使用者通常将所述装置留在适当的位置中,或者佩带所述装置一段时间,之后在不会伤害皮下组织的前提下移开并丢弃所述装置。 After the boot and is arranged on the user, the device user typically left in place in the device or wearing period of time, after the subcutaneous tissue under the premise of not harm removal and discarding of the device . 然而,在故意或意外移除的情况下,如下面更详细地描述的,可使用一种或多种安全措施以遮蔽由于启动而导致露出的针。 However, in the case of deliberate or accidental removal, as described in more detail below, may use one or more security measures to shield the exposed result due to the start of the needle.

通常,无源安全系统是最优选的。 Typically, the passive safety system is the most preferred. 这允许装置在意外移除或如果使用者“遗忘”存在安全步骤的情况下进行自我保护。 This allows the device to protect themselves in unexpectedly removed or if the user "forgotten" by the presence of security steps in the case. 由于这种装置的典型用法是提供人类生长激素,这通常在夜晚供给,因此可认为使用者(诸如佩带所述装置的儿童)实际上可整晚佩带它们,尽管这种情况下的输送仅需不到10分钟。 Since the typical use of such a device is to provide human growth hormone, which is usually supplied at night, and therefore may be considered a user (such as a child wearing the device) may actually wearing them all night, although in this case the delivery only less than 10 minutes. 如果在这期间装置掉落,要是没有无源系统的话,针可能会再刺到使用者或护理者。 If the device is dropped in this period, if there is no passive system, then the needle may then stab to the user or caregiver. 解决方法是在使用期间限制启动或者包含无源安全系统。 The solution is to limit the start or during use contains a passive safety system.

关于安全系统通常存在三个选项。 About security systems usually there are three options. 第一个选项是将针缩回到装置中。 The first option is to retract the needle into the device. 第二个选项是保护针以不会脱落,以及第三个选项是以避免针刺的方式销毁所述针。 The second option is to protect the needle does not come off, and the third option is to avoid the destruction of the acupuncture needle. 尽管每种型式都可成立,但是基本上不存在用于在没有破坏针并导致使用者遭受针刺的危险的情况下销毁针的可行的方法或装置。 Viable method or apparatus in the destruction of the needle without risk of destruction of the needle and cause the user to suffer needling although each type can be set up, but for substantially absent. 其他系统诸如有源系统,探究了一种通过辅加按钮推动或相似操作进行的人工防护和/或销毁,或人工解除安全措施。 Other systems such as an active system, or to explore a similar operation is performed by pushing the auxiliary artificial plus button protection and / or destroyed, or manually released security measures. 下面给出了本发明无源实施例的详细描述,之后给出了本发明有源实施例的详细描述。 The following detailed description is given of the embodiments of the present invention is a passive, active after the detailed description is given of the embodiments of the present invention.

为了防止无意中或意外的针刺、装置的有意的重复使用、以及遮蔽露出的针,可提供锁定针安全机构,并且在从皮肤表面上移除装置时所述锁定针安全机构可自动启动。 In order to prevent inadvertent or accidental needle, intentional reuse apparatus, and shielding the exposed needles, the needle locking safety mechanism may be provided, and upon removal of the device from the skin surface of the needle safety locking mechanism can be automatically started. 可以多种型式提供改良安全机构实施例,包括“鼠夹”类型的安全装置(无源)、针提起并覆盖类型的安全装置(有源或无源)、以及旋转针歧管类型的安全装置(有源或无源)。 Many types can provide an improved safety mechanism embodiments, including "rat trap" type safety device (passive), and lifts the needle cover type safety device (active or passive), and a rotating manifold type needle safety device (active or passive).

下面所述的另一种改良安全机构实施例包括具有和不具有“棘轮”类型锁定零件的弹簧加载的枢转横向屏障机构(无源)、人工轻按顶部的咬合或胶合的下横向屏障机构(有源)、拉出和锁定防护机构(无源)、弹簧加载的提升转换为横向防护物(无源)、弹簧辅助的有狭缝的针缩回“滑板”(无源或有源)、用于提起针的扭簧(无源)、具有和不具有粘合剂的铰接平坦防护物(无源)、以及在使用后弯曲针的安全装置(有源或无源)和双稳态片簧(有源或无源)。 Another embodiment comprises an improved safety mechanism, the top of the artificial bite or gluing Tap lower lateral barrier mechanism with and without lateral barriers pivoting mechanism (passive) "ratchet" type of spring-loaded locking element embodiments described below (active), and pull out the locking mechanism protective (passive), is converted to a spring-loaded lifting lateral shield (passive), the auxiliary spring retracts the needle of a slit "slide" (passive or active) the security device (active or passive) of the torsion spring for lifting the needle (passive), with and without binder hinged planar shield (passive), and a curved needle after use and bistable leaf spring (active or passive).

在图37到41中示出了第一改良安全实施例或鼠夹安全装置。 In FIG 37-41 illustrate a first embodiment of the improved safety device or safety rat trap. 在处于备用或偏压状态下的该安全装置实施例中,与弹簧(即,安全弹簧)结合在一起的套筒被缩回以允许针露出并使用。 Sleeve embodiment, the spring (i.e., the safety spring) in the embodiment of the safety device is in a standby state or bias joined together are retracted to allow the needle is exposed and used. 当从皮肤上移除装置时,弹簧偏转到其未偏压状态,并且以包围并保护针的方式将套筒拔出并布置在针周围。 When the device is removed from the skin, the spring deflecting to its unbiased state, and to surround and protect the needle and pull the sleeve manner arranged around the needle.

在图37中所示的鼠夹类型安全装置的第一示例中,示出了按钮装置700,其中在如上所述的一个多功能/步骤程序中执行装置的启动和激励。 In the first example shown in FIG. 37 murine folder type safety device, the button device 700 is shown, wherein the excitation means and starting execution of a multi-function as described above / step program. 图37是使用侧部按钮被启动并且包含本发明第一改良安全实施例的示例片状注射器或输液系统的横截面图。 FIG 37 is a side button is used to start a cross-sectional view of an example and comprises a sheet-like syringe or an infusion system of the present invention a first improved embodiment of the safety.

图37的装置包括按钮780、上部外壳705、下部外壳770、鼠夹门790、门闩锁791、以及门枢轴点792。 FIG device 37 include buttons 780, upper housing 705, lower housing 770, rat trap door 790, the door latch 791, pivot point 792 and a door. 还提供了板簧793和防护物794,并且在图38中更清楚地示出了它们。 And a leaf spring 793 also provides a shield 794, and more clearly shown in FIG. 38 of them. 当按钮780被推动时,按钮780的移动打开了至少一个阀750,移开了弹簧保持盘或销730,并且从患者针歧管745那里移除了支撑元件(未示出),允许歧管745前进。 When the button 780 is pushed, the button 780 is moved to open at least one valve 750, a spring retaining disc or moved away pin 730 and the tube 745 there is removed a support element (not shown) from the patient needle manifold, to allow the manifold 745 forward. 按钮780的移动还放松了门闩锁791,然而,当装置被粘附在使用者皮肤上时,不允许门790的移动。 Movement button 780 also relaxed the door latch 791, however, when the device is adhered to the skin of the user, does not allow movement of the door 790.

本发明该实施例的一个方面是,在该状态中,安全弹簧793处于朝向未偏压状态下的施力的恒定状态中(即,图38到41中所示的状态中)。 One aspect of this embodiment of the present invention, in this state, the safety spring 793 in a constant state biased toward the non-bias state (i.e., state shown in FIG. 38 to 41). 该恒定施压由装置附于其上的表面(即,患者的皮肤)以及用于粘附装置的粘合剂承受。 The constant pressing means attached thereto by a surface (i.e., the patient's skin) and an adhesive for adhering the device to withstand. 因此,已知安全弹簧793以与嵌在患者体内的针760起相反作用的方式操作并在期望时限内保持它们的嵌入状态。 Thus, the safety spring 793 is known to operation 760 counterproductive manner the needle is embedded in the patient and keep them in a state fitted within the desired time frame. 然而,由于所述力是当从皮肤表面移除装置时确保针760最终防护的施力弹簧793力,因此该力是机构功能性所需的。 However, since the urging force of the spring 793 is to ensure the force of the needle 760 is removed when the final protection device from the skin surface, so that the force is required for functional organization. 因此为了抵消该力,本发明实施例的另一个方面是包含鼠夹门790。 To counteract this force and therefore, another aspect of embodiments of the present invention comprises a rat trap door 790.

鼠夹门790用于以减小安全弹簧793实际传输到皮肤表面上的力的一种方式俘获安全弹簧793。 Rat trap door 790 for secure spring 793 to reduce the actual transmission trapping safety spring 793 in a manner to force the skin surface. 陷阱门790使用杠杆原理(诸如通用鼠夹中所发现的)在安全弹簧793上产生门790的机械优点。 Trap door 790 using the principle of leverage (such as a universal clamp found in murine) gate 790 generate mechanical advantage in the safety spring 793. 因此,当将门790折叠在安全弹簧793上时,安全弹簧793在门790上距离门铰链792的预定点处施加压力,这减小了安全弹簧793的压力点与门790的铰链792之间距离的比例倍数的安全弹簧793的力。 Thus, when the door 790 is folded at 793 the safety spring, the safety spring 793 applies pressure at a predetermined distance from the door hinge point 792 on the door 790, which reduces the distance between the point of pressure safety spring 793 and a hinge 792 790 force of safety spring 793 is a multiple of the ratio. 在使用时,皮肤表面将仅感觉到安全弹簧793的实际力的一小部分而不是其全部力。 In use, the skin surface will feel only a small portion of the force instead of the entire security of the actual force of the spring 793.

然而,当从皮肤表面上移除装置时,如图38到41中所示的,当陷阱门前进到其完全展开状态下时安全弹簧793将陷阱门790推离装置。 However, when the apparatus is removed from the skin surface, as shown in FIG. 38 to 41, when the trap door to its fully deployed state proceeds security spring 793 away from the trap door 790 apparatus. 由于在792处铰接的门790的机械优势,导致安全弹簧793在门790上的初始压力较轻。 Since the mechanical advantage of the hinged door 790, 792, 793 cause the initial pressure safety spring 790 in the door lighter. 然而,当门790被推动并枢转得远离装置时,成比例地降低了机械优势。 However, when the door 790 is pushed and pivoted away from the apparatus, proportionally reduces the mechanical advantage. 因此,安全弹簧793将加速从而在其前进长度终端或接近终端处实现安全弹簧793的全部强度。 Thus, the safety spring 793 so as to accelerate its forward end length or near full strength is achieved at the terminal 793 of safety spring. 该安全弹簧793强度是用于确保任何锁定机构,诸如安全弹簧套筒794上的第一制动装置(未示出)和任何第二制动装置(未示出)可使用安全弹簧793力被接合和锁定以克服制动装置的阻力所必需的。 The strength of the spring 793 is a security to ensure that any locking mechanism, such as the first brake means (not shown) on the safety spring sleeve 794 and any second braking device (not shown) may be used by security force of the spring 793 engaging and locking means to overcome the resistance required for braking. 最后,当安全弹簧793被完全展开时,弹簧套筒794将保护针760并且制动装置将不允许收缩,因此防止针760被获取或重复使用。 Finally, when the safety spring 793 is fully extended, the spring sleeve 794 to protect the needle 760 and the brake means will not allow contraction, thus preventing the needle 760 is acquired or re-use.

在图116中示出了第二改良安全机构实施例,或者针提起并覆盖类型的安全装置,并且所述安全装置包含通称为止转棒轭1950或“曲柄和有狭缝的十字头”的部分。 In FIG 116 shows a second embodiment an improved safety mechanism, or a needle lift and cover type safety device, and the security device comprises a scotch yoke 1950 so far known or "crank and crosshead slit" section . 在题为Ingenious Mechanisms forDesigners(Industrial Press)251页的文献中披露了所述方法的其他细节,这里合并参考其相关内容。 Further details of the method are disclosed in the literature entitled Ingenious Mechanisms forDesigners (Industrial Press) 251 pages, the relevant contents of which incorporated herein by reference. 在本实施例中,针歧管1956与弹簧加载曲柄1952相连接。 In the present embodiment, the needle manifold 1956 and the 1952 is connected to a spring-loaded crank. 曲柄1952具有与歧管1956相通的销1954,因此当曲柄1952旋转时,歧管1956被向下驱动以埋入所述针(未示出)。 1952 and 1956 having a crank pin 1954 of the manifold in communication, so when the crank 1952 rotates, the manifold 1956 is driven downward to the embedded needle (not shown). 曲柄1952在与表示针完全嵌入深度的点处停止旋转以允许流体被输送。 Stopping the rotation of the crank at a point 1952 indicates the needle is fully embedded depth to allow fluid to be delivered. 在允许歧管1956进一步向下移动而从使用者皮肤上移除装置时,曲柄1952被“放松”并且可继续旋转,依照止转棒轭的原理,这将针歧管1956从皮肤中抽出到安全位置。 When the manifold 1956 allows further downward movement means is removed from the skin of the user, the crank 1952 is "relaxed", and may continue to rotate, in accordance with the principles of the scotch yoke, which the needle is withdrawn from the manifold 1956 to the skin secure location.

如图116中所示的,使用与患者针歧管1956相接合的止转棒轭机构实现所述提升,并且被示为使用前位置(a)、使用中位置(b)以及使用后位置(c)。 As shown in 116, using the patient needle manifold 1956 engaging scotch yoke mechanism to achieve the lift, and is shown as a pre-use position (A), in-use position (b) and after use position ( c). 扭簧1952具有销或凸轮臂1954,所述凸轮臂1954具有通过有狭缝的歧管元件1956驱动的凸轮。 The torsion spring 1952 has a pin or cam arm 1954, the arm 1954 having a cam driven by the manifold member has a cam slot 1956. 当弹簧1952施加旋转力时,臂1954将歧管1956驱动到皮肤表面(未示出)中,所述皮肤表面还阻滞臂1954的进一步前进。 When a rotational force is applied to the spring 1952, the arm 1954 is driven to the manifold 1956 of the skin surface (not shown), the skin surface further block 1954 further advancement arm. 当被移除时,臂1954没有前进,在这种情况下,提升并缩回歧管1956。 When removed, the arm 1954 is not advance, in this case, to lift and retract the manifold 1956.

安全机构的鼠夹和止转棒轭类型实施例是无源系统,所述系统不需要使用者执行辅助步骤使得针具有安全性。 Murine safety mechanism folders and scotch yoke type of embodiments is a passive system that does not require additional steps performed by the user so that the needle having a safety. 所述无源系统必须使用某些装置触发安全机构的展开,并且最有效的无源系统是感觉接近于皮肤表面并且当从皮肤表面移除时展开安全机构的那些。 The passive systems use a passive system must expand some safety device trigger mechanism, and the most effective deployment and feel close to those of the skin surface when the safety mechanism is removed from the skin surface. 皮肤的“感觉”是指感觉的元件与展开的元件之间的直接关系。 Skin "feel" refers to the direct relationship between the elements and the sense element unfolded. 以上所述的实施例通过将使用者在皮肤上感觉到的安全机构的力减小到感觉不到的低值而改良了传统无源安全设计。 The above-described embodiments of the safety mechanism via the force felt by the user on the skin is reduced to a low value and improving the feel of the traditional passive safety design.

如图117到122中所示的,包括在其已展开之后将针从皮肤中拉出的本发明的另一个实施例使用斜面机构。 As shown, including after it is expanded to 117-122 embodiment shown in the present invention is further drawn out of the needle from the skin using Example ramp mechanism. 如上所述的,微型输液器包括至少一个驱动弹簧,所述驱动弹簧用于使针或一列针埋入到使用者皮肤中。 As described above, the micro-infusion comprising at least one drive spring, the spring for driving the needle or a needle is embedded in the skin of the user. 以这种方式故意地布置驱动弹簧,即,使其可将针驱动到皮肤中。 In this way the drive spring deliberately arranged, i.e., so that the needle can be driven into the skin. 在图117和118中所示的实施例中,当输液完成时,可将诸如斜面1004等机构提供和布置得允许使用者使得斜面1004与歧管1000或针头或针阵列相接合,并且通过朝向歧管1000推动斜面1004,所述针(未示出)可向上倾斜,或从使用者的皮肤中被拉出。 In the embodiment illustrated in FIGS. 117 and 118, when the infusion is completed, it may be provided and arranged so that the inclined surface 1004 allow a user with the manifold 1000, or an array of needles or the like engagement mechanism 1004 such as a ramp, and by orientation the manifold 1000 push the inclined surface 1004 of the needle (not shown) can be tilted upward or from the user's skin is pulled out. 然而,如果允许驱动弹簧(未示出)停留在在针的歧管1000上施力的位置中的话,那么就克服驱动弹簧的力进行针的该提升操作。 If, however, allowing the drive spring (not shown) remain in the needle manifold 1000 urging position, then it will be against the force of the drive spring the needle lifting operation.

如图117和118中所示的,示出了无源缩回楔形设计,所述设计具有患者针歧管1000,所述患者针歧管1000具有从其相对侧延伸的基本为圆形的销1002,以便于当斜面被弹簧1008朝向歧管1000驱动时与斜面1004的斜面相接合。 As shown in FIG. 117 and 118, illustrating a retracted passive wedge design, said design having a patient needle manifold 1000, the patient needle manifold 1000 having opposing sides extending therefrom substantially circular pin 1002, so that when the ramp is driven towards the spring 1008 when the manifold 1000 and the inclined surface of the inclined surface 1004 engages. 斜面1004不会过早地通过通过粘合皮肤感测拉出元件1006固定的狭缝1012提升歧管1000。 Ramp 1004 adhesive does not prematurely pass through the skin of the sensing element is pulled out of the fixed slits 1006 1012 1000 lifting manifold. 如上所述的,整个组件被设置在输液装置中。 As described above, the entire assembly is provided in the infusion device. 在使用之后,由于装置粘在皮肤表面(未示出)上,因此从皮肤上移除所述装置并且将粘合拉出元件1006向下从装置中拉出。 After use, the stick on the skin surface since the means (not shown), thus removing the adhesive means and the pull-out element 1006 down and out of the device from the skin. 这时,楔形1004的狭缝1012与拉出元件1006相脱离并且楔形1004被驱动在歧管1000的销1002上,如图118中所示的。 In this case, the slit 1012 to the extension member 1006 is disengaged from the wedge 1004 and 1004 is driven in the wedge-shaped pin 1002 of the manifold 1000, 118 shown in FIG. 这提升了歧管1000并且针(未示出)缩回到装置并且针开口由楔形1004从内部覆盖。 This improves the manifold 1000 and the needle (not shown) and the needle retracted into the device is covered by a wedge-shaped opening 1004 from the interior.

在本实施例中,楔形1004或防护物是一模制零件并且被布置在启动按钮(未示出)与歧管1000之间。 In the present embodiment, the wedge-shaped shield 1004, or is a molded part and is arranged in a start button (not shown) between 1000 and the manifold. 弹簧1008也布置在楔形1004与按钮之间。 1008 spring 1004 is also disposed between the wedge and button. 弹簧1008被预加载得仅足以抵偿按钮和缩回的所需行程之间的行程差异就可以。 Spring 1008 is preloaded only enough to compensate for the difference between the stroke and the desired stroke of the button can be retracted. 皮肤感测拉出元件1006将楔形1004保持在适当的位置中。 Skin sensing pulled the wedge element 1006 1004 held in position. 皮肤感测拉出元件1006由可滑动按钮部件(未示出)保持在拉出元件1006的侧部凹口1014中。 Skin sensing element 1006 is pulled out by a slide button member (not shown) held in the pull-out element side recess of 10,141,006.

当按钮被按下时,它移动直到存在用于放松皮肤感测拉出元件1006部件的侧部凹口1014并且同时将弹簧1008压制到其全位移处的间隙。 When the button is pressed, it moves until there is a relaxation of the skin drawn sensing element side recess 1014 and 1006 while the spring member 1008 is pressed into the gap at its full displacement. 由于皮肤的存在使得皮肤感测拉出元件1006停留在位置中。 Due to the presence of the skin such that skin drawn sensing elements 1006 remain in position. 歧管1000被放松并且将针安放在皮肤中。 The manifold 1000 is placed in relaxed and the needle in the skin. 在从皮肤上移除之后,皮肤感测拉出元件1006大表面面积上的粘合剂向外拉,这释放了正处于弹簧加载状态下的楔形1004。 After removal from the skin, the skin on the sensing drawn adhesive member 1006 to pull out a large surface area, which releases the wedge 1004 is in the spring-loaded state. 楔形1004向前移动,提升歧管1000,缩回针并覆盖进入孔。 Wedge 1004 is moved forward, lifting the manifold 1000 into the holes, and covers the needle is retracted.

在本实施例中,存在可被控制的力平衡问题。 In the present embodiment, there is a force balance can be controlled. 用于驱动楔形1004的弹簧1008在展开时会损失力。 1004 for driving the wedge spring 1008 during deployment force will be lost. 设置在歧管1000上并在歧管1000上被向下压制的歧管驱动弹簧(未示出)在由驱动楔形1004提升歧管1000而被压缩时增加力。 Is provided on the manifold 1000 and the drive tube spring 1000 is pressed down on the manifold manifold (not shown) increases the driving force when the lifting wedge 1004 and manifold 1000 are compressed. 这可能被非常强偏压的楔形弹簧1008压倒,然而这不利地影响了压制按钮所需的力。 This can be a very strong spring biased wedge overwhelm 1008, however, this adversely affects the force required to press the buttons.

因此,在图119中示出了上述实施例的另一个型式。 Thus, in FIG. 119 illustrates another version of the above embodiments. 本实施例的概念包括一起被向前发射的歧管1000和滑架1005。 Concept of the present embodiment includes a manifold 1000 together and transmitted forwardly of the carriage 1005. 歧管驱动弹簧(未示出)直接驱动滑架1005,而歧管1000与滑架1005相连接。 Manifold drive spring (not shown) directly drives the carriage 1005, the manifold 1000 and is connected to the carriage 1005. 在这种情况下,在通过将歧管推离制动部分1007而脱开安全器之后,楔形1004用于将歧管1000与滑架1005相分离。 In this case, the portion of the manifold away from the brake release safety device after 1007, 1004 for the wedge 1000 carriage manifold 1005 phase separation. 因此当它们保持压在目前独立的滑架1005上时,无需克服歧管的驱动弹簧。 Thus, when they are kept pressed against the carriage 1005 separate current, required to overcome the spring drive manifold.

改良设计的另一个型式是使用楔形1004的初始行程将歧管1000的驱动弹簧推动得不成直线以使得它们弯曲并且在缩回期间不再能够在歧管1000上施加正常载荷。 Another type of design is improved using the initial stroke of the wedge manifold 1004 spring 1000 pushes the drive was not a straight line so that they bend over and normal load is applied to 1000 during retraction is no longer possible in the manifold pipe. 这两种型式还具有使得歧管1000不能被重新烧制和重复使用的优点。 Both types also has a manifold 1000 that can not be re-fired and re-use advantages.

在图117、118和119的实施例中,防护物是无源的并且用材料完全覆盖所述针。 In the embodiment of FIGS. 117, 118 and 119, the shield material is passive and completely covers the needle. 所述防护物是用具有高强度的模制部分构成的并且在注射期间不会向皮肤表面施力或影响针区域处存在的粘合剂。 The shield is composed of a molded part having a high strength and does not affect the surface or the presence of urging the needle region of the adhesive to the skin during injection. 在使用之后针被保持在内部并且弹簧1008始终都是最小加载的。 After use the needle is held within a minimum and the spring 1008 is always loaded. 本实施例不需要力平衡因此展开的弹簧1008压制驱动弹簧并且皮肤粘附表面需要解除安全防护。 Example no force balance spring according to the present embodiment thus expand compressed drive spring 1008 and the skin surface to be adhered is released security. 因此,低皮肤粘合性或高摩擦是有意义的。 Thus, high or low adhesion to the skin friction is significant. 另外,包含三部分,导致了装配复杂性并且需要较长行程操作(即,增加装置尺寸)。 Further, it consists of three parts, resulting in the complexity of the assembly and requires a long-stroke operation (i.e., increasing the size of the device). 另外,与大多数压缩弹簧机构一样,所述弹簧也可能经历蠕变。 Further, as with most compression spring means, said spring may undergo creep.

本发明该实施例中所包含的斜面元件1004包括斜面形状,所述斜面形状浅得足以克服斜面上的摩擦(即,在提升歧管1000时销1002与斜面1004之间的摩擦)和驱动弹簧的力(即,向下推动歧管1000的力)两者,如果不是这么浅的话,按钮的“行程”或平移就会不利地较长。 Examples ramp element 1004 included in the embodiment of the present invention includes a ramp shape, the ramp shape of shallow enough to overcome the friction on the inclined surface (i.e., the friction between the pin 1000 when the manifold 1002 and lift ramp 1004) and a drive spring force (ie, pushing down force manifold 1000) both, if not so shallow, then the button "stroke" or translation will adversely longer. 如上所述的,本实施例的另一个方面是斜面的平移的使用以影响歧管弹簧,诸如在歧管1000上方“敲击驱动弹簧的杆”。 Described above, another aspect of the present embodiment is used to affect the translation of beveled spring manifold, such as manifold 1000 above the "knock rod drive spring." 本实施例使用这样的结构(未示出),所述结构不仅是将针从皮肤中拉出所需的而且也是将驱动弹簧从其与针歧管1000相接合的状态下移开所需的,从而消除驱动弹簧施加的力,并且使得针的相应提升更容易。 This embodiment uses such a configuration (not shown), the structure of the needle from the skin is not only required but also driving spring pulled away from its desired state of the needle manifold 1000 is engaged , thereby eliminating the force exerted by the drive spring, and that the corresponding needle lift easier.

本实施例的另一个方面,包含这样一种结构,当所述针已被成功地从皮肤中拉出并返回到装置中时,所述结构将在针上提供横向屏障。 Another aspect of the embodiment of the present embodiment, comprises a structure that has been successfully pulled out and returned to the device from the skin when the needle, the transverse barrier structure provided on the needle. 这些针通常足够小,以使得它们需要专用功能部件以确保它们适当地埋入到使用者的皮肤中。 These pins are usually small enough so that they require special features to ensure they are properly embedded into the user's skin. 这些针零件自然延伸到装置的底部,并且除非完全缩回否则都将难以由简单的横向屏障覆盖,所述横向屏障可能使得针弯曲和折断。 These pins extend to the bottom parts of natural means, and unless otherwise it will be hard to fully retracted covered by a simple lateral barrier, the barrier may be such that the lateral bending and breaking the needle. 因此在斜面本身的情况中,本发明的该实施例可用于提升针以使得横向屏障在没有折断针的前提下被展开,这是由于折断的针可对环境有害。 Therefore, in the case of the ramp itself, the embodiment of the present invention may be used to lift the needle so that the transverse barrier is deployed without the premise of the broken needle, which needle may be broken due to harmful to the environment.

与止转棒轭类型相似的另一个实施例包括使用如图120、121和122中所示的V形狭缝机构将它们展开之后用于将针从皮肤中拉出的机构。 Another scotch yoke with a similar type of embodiment includes the use of a V-shaped slot mechanism shown in FIG. 120, 121 and 122 after their deployment mechanism for the needle is pulled out from the skin. 在本发明该实施例的无源缩回狭缝设计中,使用者通过按压歧管而开始装置的操作以启动所述装置。 In this embodiment the passive embodiment of the present invention is the design of the retraction slot, the user operation is started by pressing the manifold means to activate the device. 在输送之后,使用者从皮肤上移除装置并且粘合剂将小锁定从主滑板的通路中拉出。 After delivery, the user removes the device from the skin adhesive and the small locking slide drawn from the main passage. 之后所述歧管缩回到装置中并且针从中穿过的孔由滑板覆盖。 After the manifold is retracted into the device and the needle hole is covered by the slide therethrough.

如图120中所示的,示出了无源缩回狭缝设计,所述无源缩回狭缝设计具有从其相对侧延伸的销1016的滑板1015,以便于与形成在元件1022中的V形槽1020相接合,并且由一对弹簧1025在狭缝1020中驱动滑板1015。 Showing 120 shown in FIG passive retraction slot design, the design of the passive retraction slot 1015 has a sliding plate extending from opposite sides of the pin 1016, so as to form with the element 1022 V-shaped groove 1020 is engaged in the slot 1015 and the driving slide plate 1020 by a pair of spring 1025. 如上所述的,整个组件被设置在输液装置中。 As described above, the entire assembly is provided in the infusion device. 如上所述的,使用者通过按压装置(诸如上述实施例中所述的歧管或按钮(未示出))从而压制图120中所示的弹簧1025而开始装置的操作。 As described above, the operation by the user pressing device (such as the above embodiments described in the manifold or button (not shown)) so that the pressing of the spring 1025 shown in FIG apparatus 120 starts. 在通过放松装置(诸如使用者按钮)启动所述装置之后,弹簧1025被放松并且在由狭缝1020引导时,驱动元件1022朝向皮肤表面压迫滑板1015。 After passing through the relaxation means (such as a user button) to start the apparatus, the spring 1025 is relaxed and when guided by the slit 1020, 1022 drive element 1015 toward the skin surface compression slider. 滑板1015行进到最大针插入点并且皮肤表面(未示出)阻止其进一步向下行进,弹簧1025使之停止向后行进,并且狭缝1020的倾斜突出部分阻止其进一步向前。 1015 proceeds to slide the needle insertion point and the maximum skin surface (not shown) to prevent further downward travel of the spring 1025 is stopped so that the backward travel, and the inclined forwardly projecting portion of the slit to prevent further 1020. 当装置不再与皮肤相接触时,滑板1015被自由向下推动并且进一步向前行进到狭缝1020的向上狭槽。 When the device is no longer in contact with the skin, consisting of the slide plate 1015 is pushed down and further to the forward travel direction of the slit 1020 of the slot. 之后滑板1015的行进在设置在滑板1015下面的歧管(未示出)上施加向上力并且使得针缩回到装置中并且覆盖孔,完全封闭针。 After the travel of the slide plate 1015 in a manifold (not shown) exerts an upward force and causes the needle is retracted into the device and covers the hole, the needle is completely enclosed in the slide plate 1015 is provided below.

本实施例用材料提供了针的完全覆盖,并且可将其模制得具有非常高的强度。 Example material of the present embodiment provides a needle is completely covered, and it may be prepared mold having a very high strength. 在注射期间非常小的力施加到皮肤上并且机构不会影响存在于针处的粘合剂。 During the injection of a very small force is applied to the skin and does not affect the mechanism present in the binder at the needle. 在使用之后,针被安全地保持在内部,因此本实施例清楚地提供“使用中”或“使用后”状态的视觉反馈,并且无需额外零件。 After use, the needle is safely retained inside, the present embodiment therefore clearly provide "in-use" or "after use" state of visual feedback, and no additional parts. 然而,需要皮肤粘附以解除安全装置,从而低刺入和高摩擦可存在困难。 However, a skin adhesive to release the safety device, so that a low penetration and high friction may be difficult. 另外,与上述实施例一样,需要较长行程操作(即,增加装置尺寸)。 Further, as in the above embodiment, it takes a long stroke operation (i.e., increasing the size of the device). 另外,与大多数压缩弹簧机构一样,所述弹簧也可能经历蠕变,因此在装置寿命上可涉及高力保持和展开率。 Further, as with most compression spring means, the spring may be subjected to creep, so the life of the device may involve high force retention rate and expand.

本发明的另一个改良安全实施例是下面所述的无源完全封闭防护物。 Another modified embodiment of the present invention is safe following the passive shield completely closed. 图123是装置的透视底部图,示出了在启动之前输液装置的斗形安全防护零件的实施例的视图,以及图124是装置的透视底部图,示出了在启动之后斗形安全防护零件的视图。 123 is a perspective bottom view of the device showing before starting view of an embodiment of the bucket-shaped security part infusion device, and FIG. 124 is a bottom perspective view of the device showing the after starting the bucket-shaped safety parts of view.

旋转防护物1030可由预加载扭簧1032供以动力并且在按钮1042被压制之前在“上部”旋转位置中保持加载。 Rotating shield 1030 may be pre-loaded torsion spring powered and 1032 before the button 1042 is pressed in the "upper" rotational position remains loaded. 之后防护物1030被放松并能够自由旋转,但是由于在装置的粘合剂覆盖表面1045上接触使用者皮肤,因此阻止其旋转到完全展开位置。 After the shield 1030 is relaxed and free to rotate, but due to the contact of the user's skin the adhesive covers the upper surface of the apparatus 1045, thus preventing rotation thereof to a fully deployed position. 当所述装置不再接触使用者皮肤时,诸如当装置被移除或脱落时,防护物1030不再被皮肤表面阻挡并且旋转180度,之后被锁定在适当的位置中,完全覆盖患者针1040并且避免针刺伤害。 When the device is no longer in contact with the user's skin, such as when the device is removed or detached, no longer shield the skin surface of the barrier 1030 and rotated 180 degrees, after being locked in position, completely covers the patient needle 1040 and to avoid needlestick injuries.

如图123中所示的,针1040通常隐藏在装置的下部粘合剂覆盖表面1045上的开口1035中。 Shown in FIG. 123, the needle is usually hidden in the lower portion 1040 of the adhesive means covers the opening 1035 on the surface 1045. 使用者使用粘合剂表面1045将装置固定在皮肤上之后压制启动按钮1042以启动输液装置。 The user uses the adhesive surface 1045 of the device 1042 is fixed after pressing the start button to start the infusion device on the skin. 当装置被移除时,防护物1030被轻按下并且锁定在针1040上方的适当位置中以避免使用者看到或接触到针。 When the device is removed, the light shield 1030 is pressed and locked in place over the needle 1040 to prevent users from seeing or touching the needle.

防护物1030是模压的并且形成了通过扭簧1032预加载的板金属部分。 Shield 1030 is molded and formed sheet metal part by a preloaded torsion spring 1032. 如可在示出了装置的打开下部外壳的图125中看出的,示出了缩回到装置中的防护物1030,防护物1030的前缘包括被搁在装置的横杆元件1036上的锁定臂1034,从而保持其固定。 FIG open lower housing as can be shown in the apparatus 125 seen, is shown retracted into the shield means 1030, the shield 1030 includes a leading edge rests on the crossbar element 1036 device locking arm 1034, thereby holding it in place. 当如示出了防护物1030准备旋转的装置的打开下部外壳的透视图的图126中所示的按钮1042被启动时,按钮1042上的调整片1044推动横杆元件1036的锁定臂1034以允许防护物1030在从皮肤表面清除时弹簧的加载下旋转。 When the button is opened as shown in shield 1030 is shown ready means for rotating a perspective view of the lower housing of FIG 1,261,042 is activated, the tabs on the button bar pushing member 10421044 1036 locking arm 1034 to allow shield 1030 is rotated in a spring-loaded when removed from the skin surface. 图127示出了在使得防护物1030旋转时装置的打开下部外壳的透视图。 127 shows a perspective view of the shield such that when the lower housing opening 1030 rotating apparatus. 调整片1044从按钮1042处延伸,从而在启动期间有助于防止皮肤夹在按钮与横杆元件1036之间。 Tab 1044 extends from the button 1042, to help prevent skin sandwiched between the button and the rail member 1036 during startup.

在另一个放松实施例中,辅助臂(未示出)相对于锁定臂1034被设在90度的位置处。 Relaxation embodiment, the auxiliary arm (not shown) relative to the lock arm 1034 is provided at the position of 90 degrees in the other. 该臂的指向沿着按钮的移动轴并且在使用之前保持防护物1030固定。 Point of the arm and the holding shield 1030 secured along the movement axis prior to use buttons. 当按钮1042被压制时,按钮1042上的凸轮零件(未示出)向侧面推动辅助臂以使其可通过狭缝下降并且仅通过施加较小的力释放防护物1030。 When the button 1042 is pressed, the cam parts (not shown) to the side pushing the auxiliary arm so as to be lowered by the slits and the smaller force is released only by applying a guard 1030 on button 1042. 这也有助于消除按钮1042位置的公差灵敏性,同时允许防护物1030位于装置的下部中。 This also helps to eliminate the tolerance sensitivity of the position button 1042, 1030 while allowing the lower part of the shield device. 这也可为扭簧1032提供更多的空间并且需要更小的装置高度。 This also provides more space for the torsion spring 1032 and requires less height of the apparatus.

在输液装置给药时,图123到127的防护物1030位于皮肤表面上。 Upon administration infusion device, FIG. 123-127 shield 1030 is located on the skin surface. 当装置被故意地或意外地移除时,由于扭簧1032的作用导致斗状防护物1030通过开口1035翻下并且锁定在孔1048中的调整片1046上,其中在启动期间弹簧销被移除。 When the device is removed intentionally or accidentally, due to the action of the torsion spring 1032 causes the buckets on the lower guard opening 1030 and 1035 turn in the locking hole 1048 of tab 1046, wherein the spring pin is removed during startup .

在本实施例中,通过臂1034和/或布置在防护物1030前端的搭扣结构实现了锁定。 In the present embodiment, the arm 1034 and / or a snap-in locking arrangement achieves structure 1030 of the front end of the shield. 用于接合防护物锁定的力向外推动臂1034越过横截面的小尺寸部分从而将力保持得较低。 Shield for engaging the locking arm 1034 is a force pushing outward beyond the small-sized partial cross-section so as to force kept low. 用于消除防护物1030的力越过垂直于锁定的移动的横截面的大尺寸被施加。 Force for removing the shield 1030 is applied perpendicularly across a large cross-sectional dimension of the locking movement. 这使得用于接合锁定的力较小同时具有较大的力以消除锁定。 This makes for engaging the locking force is smaller while having a larger force to remove the lock.

扭簧1032可被加载到防护物1030上的销(未示出)上,并且弹簧臂可被锁定在弹簧背部上的调整片(未示出)下面,从而预加载弹簧并且形成稳定的子配件。 The torsion spring 1032 may be loaded onto a pin (not shown) on the shield 1030 and the spring arm may be locked on a spring back of the tab (not shown) below, so as to form a stable preload spring subassemblies and . 在按钮子配件之前,通过将枢轴装置,诸如防护物1030的主杆(未示出)按压到下部外壳中的两组搭扣中以形成该枢轴,该防护物组件将被自顶部向下装配到输液装置的下部外壳中。 Before the button subassembly, by pivot means, such as a main rod shield 1030 (not shown) is pressed to the lower portion of the housing to form the two sets of pivot fastener, the guard assembly will be from top to assembled to a lower portion of the housing of the infusion device. 弹簧的一个臂可被放松以压制在端部外壳上,并且弹簧的一个臂可被锁定在弹簧背部上的调整片下面,从而“激励”安全防护物。 A spring arm can be pressed to relax at the end portion of the housing, and a spring arm can be locked on a spring back of the tab below to "encourage" the security guard.

图123到127中所示的安全实施例是用材料完全覆盖针1040的无源安全系统的另一个示例。 123 to 127 secure illustrated embodiment is another example of a passive safety system with the needle 1040 is fully covered with the material. 所述材料被构成为金属冲压件,它可允许更小的壁厚度。 The material is configured as a metal stamping, which may allow for a smaller wall thickness. 在这种情况下,所述实施例仅要求具有抗损坏的高强度的两个辅助部分。 In this case, the embodiment requires only two auxiliary portions having tamper resistant high strength. 另外,防护物施加于皮肤上的最小力比其他实施例更远离于针接触点。 In addition, a minimum force is applied to the shield on the skin than other embodiment of the contact points further away from the needle. 然而,防护物1030需要装置中的一定空间,这可使得装置更长,并且在输送期间防护物1030压制在皮肤上。 However, the shield means 1030 needs a space, which may make the device longer and during transport shield 1030 pressed on the skin. 防护物开口1035还移除了针1040附近的较大粘附表面。 The shield also removes a large opening 1035 near the adhesive surface 1040 of the needle. 另外,与大多数压缩弹簧机构一样,所述弹簧也可能经历蠕变,并且这可能与弹簧选择和构成所需枢轴管的能力有关。 Further, as with most compression spring means, the spring may be subjected to creep, and this may constitute the spring selection and ability to pivot about the desired tube.

由于斗或防护物1030从缩回位置行进到延伸位置,因此上述实施例还可装有改良锁定机构。 Since the bucket or traveling shield 1030 from the retracted position to the extended position, the above-described embodiments may also be provided with an improved locking mechanism. 在这种情况中,防护物为模制部分并且取代具有挠性锁,防护物的枢轴可在周围“装有棘轮”从而防止倒转。 In this case, the shield is a molded part and having a flexible latch substituted, may pivot shield "with ratchet" around to prevent reversed. 图128是在启动之前输液装置的改良安全防护物实施例的透视图,而图129是在启动之前输液装置的改良安全防护零件的透视图。 128 is a perspective view of a modified prior to starting the safety part perspective view of the safety shield improved infusion device embodiment, and FIG. 129 is before the start of the infusion device.

如图128中所示的,按钮1050而非外壳保持防护物1055。 Button 1050 instead of the housing 1055 to maintain the shield 128 as shown in FIG. 当按钮1050被按下时,防护物1055被放松并且基本如上所述的被安放在皮肤上。 When the button 1050 is pressed, the shield 1055 is relaxed and substantially as described above is placed on the skin. 当从皮肤表面移除装置时,弹簧(未示出)在枢轴点处倒转防护物1055和棘轮机构1060,当其转动时与装置主体上的掣子1061相接合,以使得棘轮机构1060将防护物1055保持在适当的位置中。 When the device is removed from the skin surface, a spring (not shown) inverted shield at a pivot point 1055 and a ratchet mechanism 1060, when the rotation of the pawl 1061 engages the apparatus main body, so that the ratchet mechanism 1060 shield 1055 is held in position. 图130详细地示出了棘轮机构1060。 FIG. 130 illustrates in detail the ratchet mechanism 1060. 在防护物1055臂1057上存在棘轮齿1059,并且相应的楔或掣子1061被布置在装置上。 In the presence of ratchet teeth arms 1057 1055 1059 guard, and the corresponding wedge or detent 1061 is disposed on the device. 现在任何局部旋转都被锁定。 Now any local rotation are locked.

棘轮可具有足够大的棘轮齿1059以克服消除载荷,然而它们没有大到从装置的底部突出并进入到使用者体内。 Ratchet may have a sufficiently large to overcome the ratchet teeth 1059 to eliminate the load, but they are not large enough to protrude from the bottom of the device and into the body of the user. 另外,为了实现这些目标,要求棘轮1060将防护物1055隐藏于装置中,从而增加装置的高度。 To achieve those objectives, the ratchet wheel guard 1060 1055 hidden in the device, thereby increasing the height of the apparatus. 提供充足的弹性力以便于在棘轮1060上增量地驱动防护物1055,然而必须注意全行程与蠕变结果之间的力平衡。 Provide sufficient resilient force so as to incrementally drive the ratchet shield 1055 1060 It must be noted force balance between the full stroke of the creep results. 另外,由于弹簧未被自然地布置得被保持并且在装配时必须被装载在装置中,这需要将按钮交错在歧管和防护物之间,因此最终的装配更为复杂。 Further, since the spring is not naturally arranged and held in the device must be loaded during the assembly, which requires the push button interleaved between the manifold and the shield, so the final assembly is more complicated.

棘轮锁定提供了另一种无源安全实施例,所述实施例用材料完全覆盖针并且可由高强度零件模制而成。 Ratchet lock provides another embodiment of passive safety, the embodiment of the needle and the material can be completely covered from a high strength parts manufactured by molding. 本实施例仅需要两个辅助零件并且将在全展开或部分展开的情况下锁定以便于牢固的安全性。 The present embodiment requires only two parts and the auxiliary locks in order to secure safety in case of a full deployed or partially deployed. 施加于皮肤表面上的力比其他实施例更远离于针位点。 Force applied to the skin surface than the other embodiments further away from the site of the needle. 然而,本实施例需要装置中的一定空间,这可使得装置更长。 However, the present embodiment apparatus needs a space, which may make the device longer. 与上述实施例一样,在输送期间防护物1055压制在皮肤上,并且防护物开口移除了针附近的较大粘附表面。 As in the above embodiments, during delivery shield 1055 pressed on the skin, and a removable shield opening larger adhesive surface near the needle. 另外,与大多数压缩弹簧机构一样所述弹簧也可能经历蠕变并且在装配于装置中的过程中弹簧必须加载。 Further, most of the compression spring as the spring mechanism may also be spring-loaded and subjected to creep during assembly in the device of. 如此接近于枢轴点的棘轮锁定也需要非常高的强度。 So close to the pivot point of the locking ratchet also requires a very high strength.

本发明的另一种改良安全实施例是下面所述的无源完全封闭拉出设计实施例。 Another modified embodiment of the present invention is described below safe passive drawn embodiment is designed completely closed. 图131和图133是示出了启动之前输液装置的安全防护物零件的实施例的装置的底部透视图,而图132和图134是示出了启动之后安全防护物零件的装置的底部透视图。 FIG. 131 and FIG 133 is a diagram illustrating a bottom perspective view of the apparatus before starting an embodiment of the safety shield part infusion device, and FIG. 132 and FIG 134 is a diagram illustrating a bottom perspective view of a safety shield part of the apparatus after start- .

在图131到图133的实施例的使用中,使用者基本如上所述那样准备并使用输液装置1060。 In the embodiment using FIGS. 131 to 133 in FIG, substantially as described above, the user infusion device 1060 were prepared and used. 当从皮肤上移除装置时,附于防护物1065上的粘合剂片1062将拉出防护物1065并且在粘合剂1062离开皮肤表面之前将其锁定在适当的位置中。 When the device is removed from the skin, the adhesive sheet 1062 is attached to the shield 1065 is pulled out of the shield 1065 and 1062 away from the skin before the adhesive surface of which is locked in position. 提供了安全外壳或防护物1065,所述防护物1065包括与患者皮肤相接触的平坦表面部分。 Providing a housing or safety shield 1065, the shield 1065 comprises a flat surface portion in contact with the patient's skin. 平坦表面包括设置在其上的粘合剂1062,因此当患者从皮肤上移除装置时,粘合剂1062将用于从装置的内部展开(即,缩回或抽取)防护物1065,从而遮蔽患者针1067,否则在从患者身上移除装置时所述患者针1067将露出。 An adhesive comprising a planar surface 1062 disposed thereon, so that when the device is removed from the patient skin, the adhesive 1062 for deploying from the interior of the device (i.e., retraction or extraction) shield 1065, thereby shielding patient needle 1067, or when the patient is removed from the patient needle apparatus 1067 is exposed. 之后延伸的安全防护物1065被锁定在位置中并且避免意外伤害或暴露于患者针。 After extending the safety shield 1065 is locked in position and prevent accidental injury or exposure to patient needle.

防护物1065是模压的金属零件,所述金属零件被装配在装置1060中并且当移除粘合剂内衬和针帽(未示出)时通过按钮1064被保持在适当位置中以防止防护物1065在使用之前被启动。 Shield 1065 is stamped metal parts, the metal part is fitted in the apparatus 1060 when the removable adhesive and the liner and the needle cap (not shown) via the button 1064 is held in place to prevent the shield 1065 is activated prior to use. 粘合剂1062基本被设在两个部分中,一个位于装置1060的大部分底表面上,一个位于防护物1065的底表面上。 1062 adhesive is provided in two basic parts, a device positioned on a bottom most surface 1060, located on the bottom surface 1065 of the shield. 当装置1060被移除时,这两片独立地移动并且由于按钮1064已被推动因此现在防护物移动。 When the device 1060 is removed, and the two pieces to move independently since the button 1064 has been pushed so now moving shield. 在图134和135中所示的实施例中,在防护物1065中具有多个引导狭缝和调整片1063。 In the embodiment illustrated in FIGS. 134 and 135, a guide slit having a plurality of tabs 1063 and 1065 in the shield. 防护物1065被拉出直到其被俘获在狭缝的顶部与调整片1063之间,从而通过防护物1065上的有角度的调整片被锁定在位置中。 Shield 1065 is pulled out until it is trapped between the top sheet and the adjustment of the slit 1063 so as to be locked in position by the angled tabs on the shield 1065.

本实施例的组件可从底部被搭扣配合于装置中。 Assembly of the present embodiment may be snap fit in the device from the bottom. 当需要与初始锁定相接合时,按钮也被搭扣配合于适当位置中。 When it is desired initial lock is engaged, in a snap-fit ​​button is also appropriate position. 拉出实施例是作为独立部分提供的另一个无源安全实施例并且提供了良好的锁定,所述锁定在人力载荷下不会被压坏。 Another embodiment is drawn as a separate part of the passive embodiment provided and provides good locking is locked in the load will not be crushed human. 然而,本实施例需要装置中的一定空间,并且由于在针处需要较大的粘合剂区域并且在底部处包括至少一个非粘合剂覆盖孔,因此可能难以露出。 However, the embodiment requires a space apparatus according to the present embodiment, and since the adhesive requires a large area and the needle comprises at least one non-adhesive covering the hole at the bottom, it may be difficult to expose. 这也导致需要较大行程,并且在背侧上提供了有限的覆盖。 This also results in a larger required stroke, and provides a limited coverage on the back side. 另外,在移除时展开的情况下可避免与手指接触。 In addition, in the case of the removal can be deployed to avoid contact with the fingers.

本发明的另一个改良安全实施例是下面所述的无源扭簧缩回设计。 Another modified embodiment of the present invention is secure below torsion spring retracted passive design. 图135是处于初始位置中的输液装置的安全防护物零件的实施例的透视图,图136是处于在用位置中的安全防护物零件的透视图,图137是处于最终缩回位置中的安全防护物零件的透视图。 135 is a perspective view of an embodiment of the safety shield part of the infusion device in an initial position, in FIG. 136 is a perspective view of the safety shield part position, FIG. 137 is in the retracted position secure the final a perspective view of the shield part.

本实施例包括位于歧管1076上的销1074上的预加载内部扭簧1070。 This embodiment comprises a pre-loaded on the inner pins 1074 located on the manifold 1076 of the torsion spring 1070. 如果需要的话可使用两个弹簧。 If necessary, use two springs. 当按钮1075被推动时,歧管1076被放松并且弹簧离开断块1071并且推动歧管1076上的驱动销1072以便于在适当的速度下向下推动歧管1076到安放位置。 When the button 1075 is pushed, the manifold 1076 and the spring is relaxed and pushed away from the drive pin 1071 Block on the manifold so as to push downward 10761072 at a speed appropriate to the manifold 1076 placement. 当装置被用完并从皮肤上被移除时,可能发生两种情况中的一种。 When the device is used up and removed from the skin, of the two situations may occur. 第一,被设计得具有额外超程的歧管1076继续向前并且弹簧1070从驱动销1072上脱落,翻转180度,并且抓住歧管1076上的收缩销1074,提升歧管1076从而缩回针(未示出)。 First, was designed with additional overtravel manifold 1076 continues forward and the spring 1070 detached from the drive pin 1072, rotated 180 degrees, and the pins on the shrinkage 10761074 grasp the manifold, the manifold 1076 such that retraction of lift needle (not shown). 在本实施例的替换型式中,允许歧管1076略微向侧面移动,从而从驱动销1072(驱动销1072略短于收缩销1074)上释放弹簧1070,从而翻转到歧管1076上的收缩销1074上,提升歧管1076从而收缩针。 In an alternative version of the present embodiment, to allow the manifold 1076 to move slightly to the side, so that the drive pin 1072 (the drive pin 1072 is slightly shorter than the contraction pin 1074) to release the spring 1070, thereby reversing the contraction pin 1074 on the manifold 1076 , the shrinkage thereby lifting the needle manifold 1076.

弹簧1070的移动端应具有充足的间隙以进行180°旋转但是避免当弹簧臂从驱动销1072到收缩销1074穿过时造成伤害的危险。 Moving end of the spring 1070 should have sufficient clearance for rotation of 180 ° when the spring arm but prevent the pin from the driving pin 1074 through 1072 to a retracted risk of injury. 然而,一旦被缩回之后,弹簧1070就将歧管1076和针保存起来并且废弃所述装置。 However, once retracted, the spring 1070 will be saved together and the needle manifold 1076 and the discarding of the device. 本实施例不需要辅助零件。 Example of the present embodiment no auxiliary parts.

与上述其他实施例一样,存在这样一种无源安全机构,其中歧管为触发器并且不需要辅助零件。 As with the other embodiments described above, there is a passive safety mechanism, the trigger, and wherein the manifold is no auxiliary parts. 在注射期间没有附加力施加到皮肤上,并且在使用之后针被安全地保持在内部。 No additional force is applied to the skin during injection, and after use the needle is safely held therein. 与拉出设计不同,本实施例不影响存在于针处的粘合剂。 Different design to the drawing, the present embodiment does not affect the existence of the binder in the needle. 然而,要求具有间隙以避免由于弹簧1070的移动臂导致可能对于使用者造成伤害。 However, a clearance required to prevent movement of the arm due to the spring 1070 may result in injury to the user. 另外,与大多数压缩弹簧机构一样,所述弹簧也可能经历蠕变,并且可涉及弹簧尺寸和力模式。 Further, as with most compression spring means, the spring may be subjected to creep, and may relate to the size and spring force mode.

本发明的其他改良安全实施例包括以下所述的无源铰接防护物设计实施例。 Other passive articulation improved shield design of the present invention includes the following embodiments secure the examples. 图138是处于弹簧驱动铰接位置中的输液装置的安全防护物零件的透视图,图139是处于粘性驱动铰接位置的安全防护物零件的透视图,图140是具有保持在缩回位置中的环形整体搭扣弹簧的安全防护物的透视图,以及图141是处于启动位置中的搭扣弹簧的透视图。 138 is a perspective view of a safety shield apparatus infusion part hinge spring actuated position, FIG. 139 is a perspective view of the viscous drive coupling point safety shield part, FIG. 140 is a retaining ring in the retracted position safety was a perspective view of the entire spring fastener, and FIG. 141 is a perspective view of the snap spring in the starting position.

在图138和139中,分别示出了铰接防护物1080和1085。 In FIGS. 138 and 139, respectively, illustrating a hinged shield 1080 and 1085. 当位于装置上时,铰接防护物1080和1085是平坦的。 When the apparatus is located on the hinged shield 1080 and 1085 are flat. 防护物1080和1085被锁定为平坦的直到按钮1082和1086分别被推动,在每种情况中,防护物1080和1085都被放松,但是将装置保持于身体上的粘合剂将防护物1080和1085固定在皮肤上平坦位置中。 Shield 1080 and 1085 is locked to the flat until the button is pushed 1082 and 1086, respectively, in each case, the shield 1080 and 1085 are relaxed, it will be held by the adhesive means on the body and the shield 1080 1085 is fixed to the skin in a flat position. 当从皮肤上移除装置时,由于分别被弹簧元件1081和/或粘合表面1083推动,防护物1080和1085“弹起”,并且通过调整片1087被锁定在适当位置中。 When the device is removed from the skin, it is due to the spring and / or adhesion promoting surface element 10,811,083, shields 1080 and 1085, "bounce", and is locked in place by tab 1087.

在每个实施例中,防护物1080和1085都可为充分地铰接在一点1089处的金属零件以确保从装置处转动。 In each embodiment, the shield 1080 and 1085 may be sufficiently articulated at one o'clock metal part 1089 to ensure the rotation from the device. 铰接的金属防护物1080由弹簧元件1081驱动到延伸和锁定位置。 Hinged metal shield 1080 is driven by the spring member to an extended and locked position 1081. 具体地,可将防护物1080构成得具有多个弯曲臂1081,所述弯曲臂1081将作为弹簧作用在装置的表面上。 Specifically, the shield 1080 has a plurality of curved arms configured to be 1081, 1081 as the bending arm spring acting on the surface of the device. 臂1081被装载在装置的底部外壳上并且按钮1082将弹簧的前面(通常在距离铰链1089最远的一点处)锁定在缩回位置中。 Arm 1081 is mounted on the bottom of the housing means and the button 1082 of the front springs (typically at a distance of the hinge point furthest 1089) locked in the retracted position. 当按钮1082被推动时,防护物1080围绕铰链1089自由旋转但是皮肤将防护物保持平坦。 When the button 1082 is pushed, the shield 1080 1089 free to rotate about the hinge but the skin will remain flat shield. 在从皮肤上移除输液装置时,弹簧夹1081自身,或与提供给弹簧1085的粘合剂1083相组合,向外拉动防护物1080和1085并且通过装置前面的多个调整片1087将其锁定在适当位置中。 Upon removal from the infusion device to the skin, the spring clip 1081 itself, or in combination with the spring 1085 provided to the adhesive 1083, 1080 and pulled outward shield 1085 and 1087 through the front of the lock means a plurality of tabs in place.

由于以上所述的每个弹簧实施例都可为较长和/或较薄的零件,因此通常都被构成得具有抵抗失效载荷的能力。 Due to the above-described embodiment, each spring can be longer and / or thinner parts, thus generally are configured to be capable of resisting the failure load. 另外,弹簧1080和1085适于提供适当的保护量,甚至在具有长期载荷和长行程的情况中也是如此。 Further, the spring 1080 and 1085 is adapted to provide an appropriate amount of protection, even in the case of having a long-term load and a long stroke is also true. 在接合之后,弹簧1080和1085都足以在接合之后依需要保持在铰链1089上。 After the engagement, the spring 1080, and 1085 are sufficient to maintain as needed after the bonding on the hinge 1089.

如图140中所示的,上述实施例的替换型式包括具有用作弹簧的自然铰链的防护物1090。 , Alternative version of the above-described embodiment shown in FIG shield 140 comprises a hinge 1090 with a natural spring is used. 按钮1091将防护物1090保持在图140中所示的位置中。 Button 1090 1091 The shield remains in the position 140 shown in FIG. 在被放松之后,防护物1090被偏压成图141中所示的形状。 After being relaxed, the shield 1090 is biased into the shape shown in FIG 141. 因此在装置的启动和移除之后,通过自然铰链的操作弹簧1090被启动为图141中所示的形状,覆盖针(未示出)。 Therefore, after start-up and removal device 1090 is activated to the shape shown in FIG. Nature 141 by operation of the spring hinge, covering the needle (not shown). 装置的基底还可包括至少一个凹口,当防护物1090行进时所述凹口可锁定其后缘。 The apparatus may further comprise a substrate at least one recess, when the travel of the shield 1090 may lock recess trailing edge.

以上所述的铰接防护物实施例提供了另一种完整的无源、整体安全防护物,所述防护物可简单装配并且通过按钮的搭扣启动。 The above-described hinged shield provides another embodiment of a complete passive, the overall safety shield, the shield can be activated by a simple assembly and a snap button. 该特征好确保装置保持低档。 Wherein the holding means ensure a good low. 然而,本实施例包括弯曲元件,并且要求阻塞目的与零件硬度之间的平衡。 However, the present embodiment includes a curved element, and requires a balance between the purpose of blocking the hardness of parts. 还操作通过开口通向所述针,并且在某些情况中弹簧易于损坏。 Also operated by opening to the needle, and the spring easily damaged in some cases. 另外,本实施例在输送期间对针处的皮肤施加载荷并且很大程度上取决于铰链整体性。 Further, the present embodiment a load is applied to the skin at the needle during transport and depends largely on the integrity of the hinge.

用于在微型输液装置中防护针的另一种无源设计是当使用者从皮肤上移除装置时或者从使用者外面旋转针或者使得针“过度旋转”到安全位置。 For a further micro-infusion device is a passive or designed to shield the needle when the user removes the device from the skin of the user from the outside of the rotation needle or the needle "over rotation" to a safe location. 在图142中所示的改良旋转防护物实施例中,主要特征是使用旋转以埋入针1101,以及在从皮肤表面1104移除中使用相同或相似的旋转“路径”移除针1101。 Rotation in a modified shield 142 illustrated in FIG embodiment, the main feature is embedded in a rotary needle 1101, and using the same or similar rotary "Path" in the removal of the needle 1101 is removed from the skin surface 1104. 在图142中所示的实施例中,单个针固定臂1100围绕第一轴1102旋转。 In the embodiment illustrated in FIG. 142, a single fixed needle arm 1100 to rotate about a first axis 1102. 当针1101接触皮肤表面1104时,针1101被安放并且围绕轴1102的行进停止。 When the pin 1101 contact skin surface 1104 when the needle 1101 is mounted and the shaft 1102 is stopped traveling around. 在装置用完并从皮肤表面1104上移除装置时,重新开始围绕轴1102的旋转,将针固定臂1100送回到装置(未示出)中。 When the device runs out and remove the device from the skin surface 1104, 1102 restarts rotation about the axis of the fixed arm 1100 is returned to the needle means (not shown). 在使用之后针固定臂1100也可围绕第二轴1106旋转以再次遮蔽针1101。 After using the needle holder arm 1100 may be rotated to shield the needle about a second axis 1106 1101 again.

如上所述的,输液装置的一个优选特征是连续的流体路径,由于它具有减少无菌屏障的数量和简化装置的制造的潜能,因此这是优选的。 Above, a preferred feature of the infusion device is a continuous fluid path, since it has the potential to reduce the number of manufacturing apparatus and simplification of a sterile barrier, so this is preferable. 因此,包括经由针固定臂1100将针1101旋转到使用者皮肤1104中的实施例促进了这些优点。 Accordingly, comprising a needle holder via the rotary arm 1100 to the embodiment of the needle 1101 1104 promotes the user's skin these advantages. 该实施例还提供了将针1101旋转到使用者皮肤1104中以埋入它们,之后当从皮肤表面1104移除针1101时使得针“过度旋转”到安全位置。 This embodiment also provides a rotary needle 1101 to 1104 to the user's skin are buried, after 1104 when the needle 1101 is removed from the skin surface so that the needle "over rotation" to a safe location. 该过度旋转利用针行进的单个路径并且可用作无源或有源安全系统。 The excessive rotation of the needle with a single path of travel and may be used as passive or active safety system. 另外,所述机构在没有损害从药物容器到针1101的流体路径的整体性或可制造性的前提下具有提供安全性的潜能。 Further, without impairing the integrity of the mechanism provided from the drug container to the fluid path of the needle 1101 or having the potential manufacturability providing security.

微型输液装置的无源安全系统的另一个实施例提供了在移除时启动弹簧的不加载。 Another passive safety system micro-infusion device embodiment provides a starting spring when the load is not removed. 如上所述的,这样的输液装置使用针阵列进行皮下注射。 As described above, the use of such infusion hypodermic needle array. 它们借助于弹簧在刺入皮肤层所需的速度下被射入到患者体内。 By means of a spring which is incident into the patient at the desired rate into the skin layer. 在发生了注射之后,最好在从患者那里移除装置之后以某种方式遮蔽正处于暴露的针以防止随后的处理期间针刺伤害。 After the injection occurs, preferably after removal of the device from which the patient is in some way the exposed needle shield to prevent needle-stick injuries during subsequent processing. 如果驱动弹簧可不加载或以某种方式改变的话,可容易地将针返回到装置外壳中,这样它们就不再造成威胁。 If the drive spring may not be loaded or altered in some way, it can be easily returned to the needle means in the housing, so that they no longer pose a threat. 在本实施例中,提供了由可弯曲梁构成的臂,所述臂可通过凸轮加载并且被构成得用于射出针。 In the present embodiment, the arm is provided by a bending beam configuration, the arms can be loaded by the cam and is configured to be used to exit the needle. 图143到146示出了使用一个辅助零件实现该任务的实施例。 FIGS. 143-146 illustrate the use of a secondary part of the embodiment accomplish this task.

如图143到146中所示的,示出了包含凸轮臂机构的装置的横截面图。 Shown in FIG. 143-146, there is shown a cross-sectional view of the apparatus comprises a cam arm mechanism. 所述机构包括具有至少一个从臂处延伸并且与凸轮开口1114可滑动地连接的随动器1112的臂1110。 The mechanism includes at least one arm extending from the opening 1114 and slidably connected to the cam follower arm of 11,101,112. 所述臂在远端处还包括患者针歧管1116,所述患者针歧管1116由触发器机构1118以可释放的方式保持在适当位置中。 At the distal end of the arm further includes a patient needle manifold 1116, the patient needle manifold 1118 to 1116 the trigger mechanism is releasably held in place by. 凸轮开口1114被设在可滑动元件1124中。 The cam opening 1114 is provided in the slidable element 1124. 在使用中将看到本实施例的四个基本状态,下面将示出并详细描述这四个基本状态。 Seen in the use of four basic state according to the present embodiment will now be shown and described in detail the four basic state.

在第一个状态中,或在图143中所示的准备位置中,臂1110已静止并且组件已准备由使用者启动。 In a first state, or in a ready position shown in FIG. 143, the arm 1110 is stationary and the assembly is ready to start by the user. 这通常是产品的装配和装货结构。 This is usually the product assembly and loading structure. 在第二个状态中,或在图144中所示的弹簧扳起位置中,使用者启动按钮(未示出)并且将元件1124移到右侧。 In the second state, or in the spring 144 shown in FIG cocked position, the user start button (not shown) and the element 1124 to the right. 当通过施加于销1120的力将元件1124移动到右侧时,臂1110保持静止并且被凸轮开口1114关于静止随动器1112的移动驱动到偏斜位置中。 When the element 1124 moved by forces applied to the pin 1120 to the right, the arm 1110 and is held stationary on the stationary cam opening 1114 of the actuator 1112 moves with the drive to the skew position. 由于销1120和触发器1118都连接于按钮,因此每次移动都通过凸轮开口1114和随动器1112将臂1110布置于该弯曲状态下。 Since the flip-flops 1118 and 1120 are pin connected to the button, and therefore each move both 1114 and 1112 the follower arm 1110 is disposed at the curved state by the cam opening. 在使用时使用者以这种方式装备弹簧,这具有优于消除了与加载弹簧相关的应力和蠕变的预加载组件的优点。 In this manner the spring user equipment in use, which eliminates the advantage of having superior preload spring loading assembly associated with stress and creep. 在这种状态下,触发器1118和闩锁1122被接合并且在使用之前准备由使用者即刻发射。 In this state, the flip-flop 1118 and the latch 1122 is engaged and ready to transmit by the user immediately prior to use.

在第三个状态中,或在图145中所示的发射位置中,按钮的进一步移动将触发器1118向前移动得足够远以卸载弹簧(即,放松臂1110),将针1116驱动到皮肤表面1117中。 In a third state, or in a firing position shown in FIG. 145, further movement of the trigger button 1118 is moved forward far enough to unload the spring (i.e., release arm 1110), the needle will be driven into the skin 1116 surface 1117. 闩锁1122已通过设在元件1124中的开口被触发,允许臂1110和元件1124都被搁置在皮肤表面1117上。 The latch 1122 is actuated by the element 1124 provided in the opening, allowing the arm member 1110 and 1124 are resting on the skin surface 1117. 随动器1112、凸轮开口1114和臂1110中的剩余弹簧的力矩耦合向皮肤表面1117施加较轻压力。 1112 follower cam coupled to the remaining opening moment arm of the spring 1114 and 1110 light pressure is applied to the skin surface 1117.

在第四个状态中,或在图146中所示的安全位置中,装置已从皮肤表面1117移除并且由于随动器1112和凸轮开口1114的连接使得元件1124已转动。 In a fourth state, or in the safety position shown in FIG. 146, the apparatus 1117 is removed from the skin surface and because of the cam follower 1112 and 1114 are connected such that an opening element 1124 is rotated. 这使得臂1110再次放松为其原始状态,其中针1116缩回到外壳中。 This allows the arm 1110 to its original relaxed state again, the needle 1116 is retracted into the housing. 上述整个系统都可被设置在输液装置中。 The entire system can be disposed above the infusion device. 在图147中示出了与装置结合使用的凸轮/随动器作用的辅助用法,图147示出了这样一个示例,其中螺纹元件用于为弹簧加载,所述弹簧用于将患者针推入到患者中和从患者中取出,以及为容器内容物加压。 In FIG 147 shows a device used in conjunction with a cam / actuator with the use of the auxiliary function, FIG 147 shows an example in which a threaded element is a spring loaded, the spring for pushing the needle into a patient and removed from the patient into the patient, and the pressure container contents.

具体地,图147示出了具有用于为装置中的弹簧1126加载的扭曲的、或螺纹元件1125的实施例。 In particular, FIG. 147 shows a twisting means for a spring 1126 is loaded, or a threaded element 1125 embodiments. 弹簧1126由销或按钮1127固定,并且当放松时,迫使元件1129向前,其中位于元件1129中的槽中的销1131被迫向下之后向上,与元件1129中的槽相对应。 The spring 1126 is fixed by a pin or button 1127, and when relaxed, the forward force element 1129, element 1129 in which the pin 1131 is located in the slot after the forced upward and downward, the element 1129 corresponds to a slot. 迫使销1131向下并向下压迫枢转的容器和针组件1133。 Forces the pin 1131 downward and the lower container and compression of the needle assembly 1133 to pivot. 元件1129的进一步移动迫使销1131向上,在来自于与组件1133相接触的弹簧1126的辅助下迫使组件1133向上。 Further movement of member 1129 forces the pin 1131 upwards, forcing assembly 1133 upwardly from contact with the auxiliary spring assembly 1133 in 1126.

如上所述的,无源安全系统是最优选的,然而,有源安全系统也是实用的并且可用在若干应用中。 As described above, the passive safety system is the most preferred, however, the active safety system is also useful and can be used in several applications. 如上所述的,关于安全系统通常存在三种选项,包括将针缩回到装置中、遮蔽针以取消进入、以及以避免针刺伤害的方式毁坏针。 As described above, typically there are three systems regarding safety options, including the needle retracted into the device, the needle shield to cancel entering, and to prevent needle stick injury destroying manner. 上面已详细描述了多个无源安全机构。 The above has been described in detail more passive safety agencies. 下面将详细描述本发明的多个有源安全机构实施例。 A plurality of active safety mechanism will be described embodiments of the present invention in detail below.

在图148和149中示出了本发明的改良弹出防护物安全机构实施例。 In 148 and 149 is shown in a pop improved safety shield mechanism of the present embodiment of the invention. 除在移除装置时,使用者向下弹出防护物1130并且将防护物1130锁定在适当位置中以避免接触针1135,装置的功能基本与以上所述的相同。 Substantially the same as above except upon removal of the device, a user pop shield 1130 and shield 1130 downwardly locked in position to prevent contact with the needle 1135, the function of the device.

如图148和149中所示的,防护物1130基本上是塑料或金属的平板,所述防护物1130通过使用装置边缘处的制动部分1137的压制部分被保持在适当的位置中。 And FIG. 148, the shield 149 shown in 1130 is substantially flat plastic or metal, the shield 1130 by using the braking device at the edge of the pressing portion 1137 is held in an appropriate position. 当在使用期间装置处于皮肤表面上时,防护物1130基本是平坦的。 When the apparatus is in use during the skin surface, the shield 1130 is substantially planar. 在移除之后,使用者抓住防护物1130上的制动部分1137的延伸调整片并且关于铰链1139弹出防护物1130以“压毁并覆盖”针1135。 After removal, the user grasps extension tab portion on the brake shield 1137 and 1130 about the hinge 1130 to 1139 pop shield "cover crushing and" pin 1135. 也可提供锁(未示出)以使得在使用之后被关闭时防护物1130以不能移动的方式与装置固定在一起。 Lock may also be provided (not shown) so that the 1130 can not move in the way the device is closed after use shield secured together. 当防护物1130被锁定在位置中时,针1135和针开口两者都被完全覆盖和锁定。 When the barrier 1130 is in the locked position, the needle 1135 and needle both openings are completely covered and locked.

本实施例的组件可包括枢轴上的搭扣配合,并且压配合于初始位置中。 Assembly of the present embodiment may include a snap-fit ​​on the pivot shaft, and is press-fitted in the initial position. 也可在制造早期进行这项操作,以使得在装配装置的其余部分时它处于适当的位置中并位于装置的底部上。 This operation may be performed early in the manufacturing, so that the rest of the assembly when the apparatus is in its proper position on the bottom of the device and located. 也可在防护物1130的顶部上设置粘合剂。 Adhesive may also be provided on top of the shield 1130. 由单个零件提供这样一种有源安全机构,并且具有低档的简单组件以及提供坚实的保护。 Provided by a single active part of such a safety mechanism, and has a low and simple assembly to provide a solid protection. 然而,所述机构是有源的,这需要额外的使用者步骤。 However, the mechanism is active, it requires additional user steps. 另外,防护物1130上的粘合剂可导致装置漂浮,并且压毁针可能存在问题。 Further, the adhesive on the shield 1130 may cause the device to float, and crushing the needle may be problematic. 另外,必须仔细地布置枢轴1139以获得全旋转并避免不完全锁定。 In addition, the arrangement must be carefully pivot 1139 to obtain a full rotation and avoid not completely locked.

如上所述的,可以各种型式提供安全机构的改良实施例,包括鼠夹类型安全装置、针提起并覆盖类型的安全装置、以及旋转针歧管类型的安全装置。 As described above, the safety mechanism can provide various types of modified embodiments, including rat trap type safety device, and lifts the needle cover types of safety devices, the manifold type needle and a rotation safety device. 上面都详细描述了无源和有源机构,然而,几种机构可提供为有源或无源的。 The above describes in detail the passive and active mechanisms, however, several means may be provided as active or passive. 下面将更详细地描述本发明的多个有源/无源安全机构。 Following the present invention a plurality of active / passive safety mechanism described in more detail.

关于以上所述的无源安全机构,诸如针提起并覆盖类型的安全装置实施例等几个实施例也可作为使用者使用的有源系统,但是它们制造起来成本低廉并且使用中非常坚实。 About passive safety mechanism described above, such as a needle cover and lift type safety device embodiment and several embodiments may also be used as the active system users, but they are inexpensive to manufacture and use, very solid. 例如,在针提起并覆盖类型的安全装置中,通过驱动弹簧将针埋入所需的力可能较高。 For example, lift the cover and the safety device of the type needle, the needle is embedded by the drive spring force required may be higher. 因此,在普通有源安全机构中由使用者克服这些力可能较高并且也可能存在针的不完全覆盖的可能性。 Thus, in the conventional active safety mechanism by the user to overcome these forces may be high and the likelihood of incomplete coverage of the needle may be present. 然而作为无源安全机构实施例的上述几个提起和覆盖实施例的有利之处在于每个都具有斜面。 However, the above several embodiments as a passive safety mechanism and the cover lifted advantageous embodiment in that each has an inclined surface. 因此,在用作有源安全机构的情况下,提起和覆盖实施例也可包括斜面以便于在提起针方面获得优于驱动弹簧的优点,并且还包括完全移除驱动弹簧的可能性,这大大减少了使用者遮蔽装置所需的力。 Thus, as in the case of an active safety mechanism, and the cover lifted embodiments may include a chamfer to better advantage of the spring in the drive in terms of lifting the needle, and further includes the possibility of complete removal of the drive spring, which greatly reducing the user force required to shield means. 有源和无源安全机构两者中的最终优点在于,这些概念可有助于与斜面结构成整体的横向屏障的展开,因此制造起来成本低廉、易于使用并且使用中非常坚实。 Both active and passive safety mechanism for the final advantage is that, with the help of these concepts can be expanded to a lateral barrier to the inclined structure of the whole, and therefore inexpensive to manufacture, easy to use and use very solid.

在可作为有源或无源机构的另一种改良安全实施例中,可提供针弯曲安全机构。 In an active or passive as another modified safety mechanism embodiments, the needle may be bent to provide a safety mechanism. 在该实施例(未示出)中,所述机构可包括具有孔的板,在使用和输送过程中针从所述孔中穿过。 In this embodiment (not shown), the mechanism may comprise a plate having an aperture, said aperture passing through from the needle in use and the delivery process. 在使用之后,以有源或无源的方式,板可移动以使得板中孔的边缘在非常小规格的针上施加剪切载荷并且向侧面弯曲它们,同时覆盖它们。 After use, active or passive way to the plate so that the edge of the movable aperture plate shear load is applied on a very small gauge needle and is bent to the side thereof, while covering them.

然而,必须小心避免损坏针以及改变弯曲针所需的力度,这是由于它们应被弯曲得非常靠近存在非常小力矩臂的安装点。 However, care must be taken to avoid damage to the needle and needle bending strength required to change, since they should be very close to the curved mounting points present a very small moment arm. 该实施例可作为有源或无源机构,并且包括低档的简单整体组件。 This embodiment can be used as active or passive means, and includes a simple low overall assembly.

在可作为有源或无源机构的另一种改良安全实施例中,可提供双稳态片簧机构,具有可驱动和缩回针的单个弹簧。 In an active or passive means as another modified embodiment of the safety, the bistable leaf spring mechanism may be provided with a single spring may retract the needle and drive. 提供使用薄塑料或金属片,可形成将沿任一方向工作的偏压系统。 Providing a thin sheet of plastic or metal, may be formed biasing system will work in either direction. 通过双稳态弹簧,使用者仅需克服稳定的阻力,之后“咬合”于另一种稳定状态将提供高速安放。 By a bistable spring, the user only needs to overcome the resistance of stable, then "snap" to the other stable state will provide high-speed mounting. 相反当装置用完时,使用者仅需施加相同小的力并且装置将缩回针。 Conversely when the device is used up, the user only needs a small force applied to the same means and retract the needle.

在本实施例的另一种型式中,薄塑料部件(未示出)可被提供并支撑在一端上并且相互轻微挤压。 In another form of embodiment according to the present embodiment, the thin plastic member (not shown) may be provided and supported on one end and slightly pressed to each other. 当力矩被施加于压缩端部时,塑料将咬合成更稳定的结构。 When a torque is applied to the compression end portion, the plastic will snap the synthesis more stable structure. 当力矩解除时,塑料部件弹回。 When torque is released, the plastic member rebound. 所述双稳态弹簧可作为有源或无源机构,并且可构成为具有低档的简单整体组件并且提供高速度。 It may be used as the bistable spring means active or passive, and may be configured to have a low speed and provides a simple unitary assembly.

前述设计实施例中的大多数都可制成为有源型式的,这可简化它们之处在于,应用使用者的展开力可消除用触发器感测皮肤的需要。 Design of the foregoing embodiments can be made most active type, which are simplified in that, the force to expand the application of the user flip-flop may eliminate the need to sense the skin. 还存在种种概念,其中通过使用者作用在按钮或其他类似部件上的直接力执行缩回,之后在不用中间弹簧或其他部件的情况下移动歧管。 There is also a variety of concepts, wherein the force directly executed by the user acting on the button or other similar member is retracted, then without the use of a spring or other intermediate member manifold moves.

除以上所述的改良安全实施例以外,本发明的其他改良实施例包括改良歧管弹簧、改良填充机构、改良包装机构、以及改良剂量终端期限指示机构。 Addition to the embodiments described above safety improvement, another modified embodiment of the present invention comprises an improved manifold spring, improved filling mechanism, improved packaging means, and improved the dose indicating mechanism Term terminal.

如上所述的,当被设在输液装置中的一个或多个患者针歧管弹簧放松时,患者针歧管通常被向前推进。 As described above, when the infusion device is provided in one or a plurality of patient needle manifold spring relaxed, the patient needle manifold is typically forward. 参照图37、38和39描述了示范性装置。 Referring to FIGS. 37, 38 and 39 illustrates an exemplary apparatus. 然而,图37、38和39的歧管弹簧还可包括图150到156的改良弹簧,下面将详细描述。 However, the manifold 39 and springs 37, 38 can also include an improved spring of FIGS. 150 to 156, will be described in detail below.

在图150到156中,示出了几个改良歧管弹簧实施例。 In FIGS. 150,156, illustrate several embodiments of an improved manifold spring. 在图150、151和152中,示出了改良歧管弹簧第一实施例的透视图。 In FIG. 150, 151 and 152, is shown a perspective view of a first embodiment of an improved manifold spring. 图150和151示出了加载或弯曲位置中的弹簧,图152示出了释放或放松位置中的弹簧。 FIGS. 150 and 151 illustrate the bending or spring-loaded position, FIG. 152 illustrates the release of a spring or relaxed position. 弹簧1140包括第一和第二相邻元件1148和1145,它们相连接以便于当如图152中那样放松时基本产生锐角。 Spring 1140 includes a first and second adjacent elements 1148 and 1145, which are connected as shown so that when the base 152 is generated as an acute angle when relaxed. 当处于加载位置中时,第一元件1148被固定在第二元件1145提供的弧1144。 When in the loading position, the first member 1148 is fixed to the second element 1145 1144 arc provided. 较大的垂直元件1142被设在第一元件1148上以便于与装置中的按钮相接合,从而从弧1144上放松第一元件1148并且通过基本弯曲的元件1146施加压力。 Greater vertical member 1142 is provided on the first member 1148 for engagement with engagement means on the button, thus relaxing the arc from the first member 1148 and 1144 by applying pressure substantially curved element 1146.

在操作中,加载弹簧1140被布置在装置中的歧管1151上方。 In operation, loading manifold 1151 is disposed above the spring 1140 in the apparatus. 弹簧1140被布置在针歧管1151上方,诸如图34中的歧管520。 Spring 1140 is disposed over the needle manifold 1151, the manifold 34, such as 520 in FIG. 在图34中,弹簧581被提供得向歧管520施力,弹簧1140可被布置在歧管1140上方并向歧管施力。 In Figure 34, the spring 581 is provided to the manifold 520 have biasing spring 1140 may be disposed over the manifold 1140 and manifold force. 在图150和151中,通过第一和第二元件1148和1145的接合将弹簧1140保持在加载状态下。 In FIGS. 150 and 151, by engaging the first and second elements 1148 and 1145 of spring 1140 will remain in the loaded state. 当按钮(未示出)被启动时,垂直元件1142通过与按钮元件1159接触而接合,使得第二元件1148移动得远离固定的第一元件弧1144,直到第二元件1148被放松。 When a button (not shown) is activated, a button element 1142 by contact with the vertical member 1159 joined, such that the second element of the first element 1148 moves away from the stationary arc 1144, 1148 until the second member is relaxed. 在被放松之后,第二元件1148的基本环形接触区域1146驱动歧管1151。 After being relaxed, a second substantially annular region of contact element 1148 1146 1151 drive manifold. 环形接触区域1146确保弹簧与歧管接触在弹簧1140的整个伸展上被提供在歧管1151的中心点处。 An annular contact region 1146 in contact with the manifold to ensure that the spring is provided at a central point on the manifold 1151, the entire extent of the spring 1140. 所述接触还确保了适当的歧管行程。 The contact also ensures proper stroke manifold. 在图153到156中示出了改良歧管弹簧的其他实施例并且基本如上所述那样执行。 In FIG. 153 to 156 show other modified embodiments of the manifold of the spring and substantially performed as described above.

在图153中,图150的固定弧1144由从按钮接合元件1149延伸的更大的元件1147取代。 In FIG. 153, FIG stationary arc 1,144,150 from the button by a larger engaging member extending elements 1149 1147 substituents. 当按钮与元件1149相接合时,元件1147放松弹簧并且向前压制歧管1151,如上所述的。 When the button is engaged with the element 1149, element 1147 and compressed spring to relax forward manifold 1151, as described above. 同样在图155中,图150的固定弧1144由元件1141和1143之间的接合部分取代,并且在释放时基本如上所述那样执行。 Also in FIG. 155, FIG stationary arc 1,144,150 is replaced by the engagement portion between the elements 1141 and 1143, and upon release substantially performed as described above. 每个都包括小制动装置以避免意外脱开。 Each comprises a small braking device to prevent accidental disengagement.

在图157到163中,示出了改良“通过按钮”填充机构和方法,所述机构和方法可与以上所述的任何输液装置和改良结合使用。 In FIG. 157 to 163 shows the improved infusion can be combined with any of the above apparatus and improved "button by" filling means and method, the means and methods.

图157中所示的步骤1示出了填充程序。 In step 157 shown in FIG. 1 shows a filling procedure. 装置1150的局部横截面图示出了邻近于容器开口1154的按钮1153。 Partial cross-section illustrating a device 1150 adjacent to the container opening button 11,531,154. 在按钮1153中包含孔2153,这甚至在装配之后还允许通过容器开口1154填充装置1150。 Button 1153 contained in the hole 2153, which even after assembly 1154 also allows the device 1150 by filling the container opening. 在158中所示的步骤2中,在通过按钮孔2153填充之后,阀组件1156被装配在容器开口1154中。 At step 158 in FIG. 2, after the button hole 2153 is filled through the valve assembly 1156 is fitted in the opening of the container 1154. 因此,可通过孔2153装配阀组件1156,以使用按钮1153启动阀1156,需要以某种方式限制孔2153。 Thus, the valve can be fitted through the aperture assembly 2153 1156, buttons 1153 used to actuate the valve 1156, holes 2153 need to restrict some way. 在步骤3中,提供元件1158以关闭按钮孔2153进入口或观察窗,以允许图159中所示的阀1156的启动。 In step 3, a button element 1158 to close the hole or observation window access port 2153 to allow the valve 159 shown in FIG starting 1156. 在关闭之后,如图160中所示的,准备按下按钮1153,从而启动阀组件1156。 After closing, as shown in FIG. 160, ready to press the button 1153, thereby initiating the valve assembly 1156.

在本发明的替换实施例中,阀1156可通过开口2153被插入,之后旋转到完全步骤3。 Embodiment, the valve 1156 may be inserted through the opening 2153 in the alternative embodiment of the present invention, after the rotation step 3 to complete. 如图161和162中的按钮1153的顶视图中所示的,阀1156被构成得具有椭圆形形状,它可滑动地插入到按钮1153的相似形状的孔2153中。 , The valve 1156 is configured to have an oval shape, which is slidably inserted a top view of the button 1153 shown in FIG. 161 and 162 in a similar shape to the button 1153 of the hole 2153. 通过如图163的横截面图中所示的旋转可将椭圆形形状设计为非对称的,以使得一旦处于容器开口中的位置中之后,阀1156的旋转允许阀凸缘垂直于开口。 Rotation as shown by the cross-sectional view in FIG. 163 may be an oval shape designed to be non-symmetrical, such that once the opening of the container is in position, the rotary valve 1156 allows the valve to the opening perpendicular to the flange. 这允许按钮1153(甚至具有开口2153),以便于当按钮1153向前移动时推动阀1156。 This allows the button 1153 (or even having an opening 2153), so as to push the valve 1156 when the button 1153 to move forward when. 该选项消除了将元件1158设置得靠近于按钮观察窗2153以允许在图157到160中启动阀的需要。 This option eliminates the element 1158 disposed close to the observation window 2153 to allow the button to start the valve in the required 157 to 160 in FIG.

另一个改良实施例涉及装置填充和内容物指示。 Another modified embodiment of the apparatus and the filling contents indicated relates. 如图164到167中所示的,上述输液装置可装有剂量终端指示器以允许使用者观察药物是否已被供给,是否已被供给到更少程度,所述程度是否已被供给。 As shown in FIG. 164-167, the transfusion apparatus may be provided with a dose indicator to allow the user terminal to see whether the drug has been supplied, whether it has been supplied to a lesser extent, whether the extent has been supplied.

在一些输液装置中,可具有透明容器,使用者可完全看透容器。 In some infusion devices, it may have a transparent container, a user can be completely seen through the container. 通常,当由于化学反应导致透明材料不能与液体结合使用时,或者水/气体传输速度较高时,溶液可包括透明和非透明材料的组合的使用。 Typically, when a chemical reaction resulting in a transparent material can not be combined with a liquid, or when higher water / gas transmission rate, and may include a transparent solution using a combination of non-transparent material. 非透明材料可为任何数量的材料,诸如具有用于挠性需求的铝或用于刚性需求的涂覆材料的层压材料。 Non-transparent material may be any number of materials, such as aluminum or a laminate having a rigid need for a flexible coating material needs. 下面所述的本发明的实施例包括由用于隔膜1162的挠性、非透明材料和刚性透明材料1164构成的容器1160。 The following examples of the present invention comprises a container 1160 formed from a flexible, non-rigid transparent material and a transparent material for the membrane 1164 1162. 还提供了用于在给药开始和结束之间进行区分的可视指示器1166。 1166 also provides a visual indicator for distinguishing between the start and end of administration. 该可视指示器可为出现在输液结束时的显现或消失的标记。 The visual indicator may be visualized as occurring at the end of infusion or missing marker.

如图164和165中所示的,由指示器1166上的软材料构成的凸起凸纹1168与挠性隔膜1162相接触,并且由于容器的内容物的存在,导致与刚性透明材料1164具有一定距离。 As shown in 164 and 165 as shown, made of a soft material on the indicator relief projection 1166 1168 1162 in contact with the flexible diaphragm, due to the presence of the contents of the container, resulting in a rigid and transparent material having a certain 1164 distance. 然而,凸起凸纹1168在挠性隔膜1162中产生可通过透明材料1164看到的可视变形或轮廓1169。 However, protrusions 1168 produce a visible relief or deformation profile 1169 can be seen through the transparent material 1164 in the flexible membrane 1162. 在图164中示出了所述轮廓1169的一个示例。 In FIG 164 shows an example of the profile 1169. 如图166和167中所示的在容器1160被清空之后,由于容器1160中内容物的缺乏导致与刚性透明材料1164相接触,使得凸起凸纹1168被压扁。 As shown in FIG. 166 and 167 after the container 1160 has been emptied, the lack of the contents of the container 1160 results in contact with a rigid transparent material 1164, such that the relief protrusion 1168 is flattened. 之后消除了挠性隔膜1162的变形1169,如图166中所示的。 After eliminating the deformation of the flexible membrane 1169 to 1162, as shown in 166. 因此本实施例可用于提供流体分配的直接观察,然而,其他实施例也可以包括计时器和压力控制/传感器等多种方式提供剂量终端指示。 Thus direct observation embodiments may be used to provide a fluid distribution of the present embodiment, however, another embodiment provides a dose terminal indicates a number of ways may also include a timer and a pressure control / sensor.

为了提供以上所述的本发明的实施例,挠性材料被提供为隔膜1162。 For embodiments of the present invention provides the above, the flexible membrane 1162 is provided as the material. 在注射开始时,“可变形信号”1168被施加在挠性隔膜1162上,因此,施加于凸起凸纹1168上的力是施加于膜1162和容器内容物上的力,因此这很大程度上导致凸纹1168的较小变形。 When injection starts, "deformable signal" 1168 is applied to the flexible diaphragm 1162, and therefore, the force applied to the protrusion 1168 on the relief force is applied to the film 1162 and the contents of the container, so that a large extent results in a smaller deformation of the relief 1168. 在输液或注射结束或接近结束时,隔膜或膜1162与容器1160的硬透明部分1164相接触,并且凸起凸纹1168被压制在容器上并且标记1160消失。 Infusion or injection at the end or near the end, a diaphragm or membrane 1162 and 1160 of the container rigid transparent portion 1164 is in contact, and the projection 1168 is pressed ridge on the container and labeled 1160 disappears.

在本发明的另一个改良可视指示实施例中,微型输液装置可包含另一个零件,即,用于可视地指示何时完成药物输送。 In another refinement of the present invention, a visual indication embodiments, the infusion device may include a micro other part, i.e., for visually indicating when the drug delivery is completed. 如上所述的,输液装置的几种设计包括与相似部件相组合的针歧管,并且所述输液装置沿用于插入的患者皮肤的通常方向移动。 As described above, the infusion device comprising several design similar to needle manifold member in combination, and generally follow the direction of the infusion device to the skin of a patient insertion movement. 之后针歧管从患者的皮肤上移开以便于缩回。 After removal of the needle manifold so as to be retracted from the patient's skin. 该零件与装置的外壳的上部壳体和下部壳体一起可用于提供所述可视指示器。 An upper housing and a lower housing part and the housing of the device with the visual indicator may be used to provide.

在输液过程中,下部壳体被附于患者皮肤,而上部壳体是距离皮肤最远的外壳部件。 During the infusion, the lower housing is attached to the patient's skin, the skin and the upper housing is furthest from the housing member. 该上部外壳对于患者(或者使用输液装置的人)来说通常是可视的。 The upper portion of the housing to the patient (or the person using the infusion device), it is generally visible. 如上所述的通常称作针歧管的部件被布置在输液装置中。 Commonly referred to needle manifold member as described above is arranged in the infusion device. 一个或多个微型针或非常小的套管被永久地固定在该针歧管中。 One or more microneedles or very small cannula is permanently affixed to the needle manifold. 该针歧管也以各种方式被附于流体容器,以便于形成连续的、防漏的、流体路径。 The needle manifold may also be attached in various ways to the fluid container, so as to form a continuous, leak-proof, fluid path. 提供所述路径以允许流体从流体容器中通过一个或多个流体控制装置、通过针歧管和微型针的远端、并且进入到患者体内。 Providing a path to allow fluid from the fluid reservoir through one or more fluid control device, the distal end of the needle through the needle and micro manifold, and into the patient.

在药物输送的输液程序开始或接近开始时,套管刺入并进入患者皮肤以输送容器所提供的流体、液体、气体或蒸气药物。 When the delivery program or near the start of drug delivery begins, the cannula puncturing the skin and into the patient to deliver fluid, liquids, gases or vapors medicament container is provided. 药物可选择地被输入到患者表皮下面的目标区域中。 Alternatively, the drug is input into the patient beneath the epidermis target region. 为了刺入皮肤以使得可进行药物输送,歧管弹簧沿基本垂直并朝向患者皮肤表面的方向(以及沿通常与套管的长轴平行的方向)由针歧管推动。 In order to penetrate the skin so that the drug delivery can be carried out, the manifold and the spring in a substantially vertical direction toward the patient's skin surface (as well as a direction generally parallel to the long axis of the sleeve) is pushed by the needle manifold. 如上所述的,针歧管移动也可被设计为旋转机构,然而,也可包含该改良可视指示器实施例的突出指示器元件。 As described above, the movement of the needle manifold tube may also be designed as a rotation mechanism, however, it may also comprise an indicator element protruding modified embodiment of the visual indicator. 在药物输送的输液程序结束或接近结束时,通过沿通常远离皮肤的方向移动针歧管和/或通过沿与其先前移动相反的方向移动针歧管而从患者体内抽出套管。 At or near the end of the drug delivery infusion procedures, movement of the needle manifold and / or the needle manifold by moving its previous movement opposite directions withdrawn from the patient through the cannula a direction generally away from the skin.

在示例实施例中针歧管行进的总距离可接近3到6毫米(3mm到6mm)。 Examples total distance traveled in the needle manifold of the exemplary embodiment accessible. 3 to 6 (3mm to 6mm) mm. 然而,优选设计特征是使得发生该行进的输液装置的高或“高度”最小化。 However, preferably designed so that the infusion device is characterized in that the occurrence of high traveling or "height" is minimized. 为了其他功能性需求,针歧管通常是输液装置中最高部件中的一个。 For other functional requirements, the needle is typically infusion manifold member highest one. 在这种理解中,“高”方向是在输液装置布置的区域中垂直于皮肤表面的方向。 In this understanding, the "high" direction is a direction in the region of the infusion device is arranged in perpendicular to the skin surface. 出于这些原因并且为了适应所需的移动,在储存、使用之前以及在针歧管移动以使得套管插入到皮肤中之前,针歧管的顶表面将靠近于上部壳体的内表面或与内表面相接触。 For these reasons and in order to accommodate the movement of the desired, prior to storage, prior to use and move the needle cannula so that the manifold is inserted into the skin, the top surface of the needle near the manifold to the inner surface of the upper housing or contacting the inner surface. 当开始输液程序时,在套管插入期间针歧管移动得远离上部壳体的内表面,在上部壳体与针歧管之间形成间隙或间隔。 When the program starts the infusion, the needle moves within the manifold away from the upper surface of the housing during insertion sleeve, a gap or space is formed between the upper housing and the needle manifold. 当完成流体输液时,针歧管和套管被缩回,从而返回到其起始位置。 Upon completion of the infusion fluid, the needle manifold and sleeve are retracted, thereby returning to its starting position. 本发明的实施例包括设置在针歧管顶部处的零件,患者或使用者可通过上部壳体中的零件观察。 Embodiments of the present invention comprises a needle part is disposed at the top of the manifold, the patient or user may be observed through the upper housing part.

在第一个实施例中,针歧管可具有圆柱棱镜或近似于棱镜的零件,所述零件可从针歧管的顶表面和/或顶表面上方突出。 In a first embodiment, the needle manifold may have a cylindrical prism or a prism similar parts, said parts may protrude from / over a top surface of the needle and the manifold or top surface. 该突出零件可与针歧管主体整体模制,或者它可为附于针歧管主体的独立部分。 The protruding part of the needle manifold may be integrally molded body, or it may be a needle attached to a separate manifold body portion. 该突出零件是高反射性的和/或明亮对比颜色的以便于最优可视性。 The protruding parts are highly reflective and / or bright contrasting colors to facilitate optimum visibility.

与以上所述的针歧管突出零件相对应,可通过顶部壳体在通常位置并以适当的尺寸提供开口,或将其提供为装配于顶部壳体或通过顶部壳体装配的透明视窗或模制透镜状装置。 The needle manifold tube above the corresponding projecting parts, and may be suitable dimensions in order to provide an opening in the normal position by the top of the housing, or provided to be fitted to the top of the housing, or by molding a transparent window or top of the housing assembly It means lenticular system. 针歧管上的突出零件将滑动地装配于顶部壳体开口中或通过顶部壳体开口装配,或滑动地装配于透明窗内部区域上的凹形袋状区域中。 Projecting parts on the needle manifold slidably fitted to the top of the housing opening or through the top opening of the assembly housing, or slidably fitted to the concave pocket region on the interior region of the transparent window. 为了容纳枢转或文本类型的指示器,可在顶部壳体中提供更大的矩形或椭圆形形状的视窗。 To accommodate pivoting or text type indicator, a larger window may provide a rectangular or oval shape in a top of the housing.

如上所述的,针歧管上的突出零件是高反射性的和/或明亮对比颜色的以便于最优可视性。 As described above, the projecting parts on the needle manifold is highly reflective and / or bright contrasting colors to facilitate optimum visibility. 在其他实施例中,单色指示器可包括文本,诸如词语“Ready”、“OK”、或“Start”,在开口或视窗的示例中它们是可视的。 In other embodiments, the indicator may comprise a monochromatic text, such as the words "Ready", "OK", or "Start", in the example of the opening or window they are visible.

另外,通过增加至少一个辅助部分,具有双位置指示器的另一个实施例也是可行的。 Another Further, by adding at least one auxiliary section, having a dual position indicator embodiments are possible. 该双位置或枢转指示器可包括输液之前的上述引证的文本(标记),并且当针歧管已向下行进并且处于返回行程中时,整体的或附于枢转指示器的弹簧可弹出指示器以形成可视的辅助文本,诸如词语“End”、“Done”、或“Remove”。 The two-position or pivot indicator may include text previously cited above infusion (mark), and when the needle has traveled down the manifold and the return stroke is, integral or attached to the pivot spring to eject the indicator to form an auxiliary indicator is visible text, such as the word "End", "Done", or "Remove". 具有标记的移动零件还可相对于针歧管滑动而不是枢转。 Tagged with moving parts may slide relative to the needle manifold rather than pivoting.

在使用中,以上所述的本发明实施例允许环境光穿过顶部壳体中的透明透镜或视窗,所述环境光从布置得靠近于视窗的凹形袋或视窗的凹形袋中的突出指示器表面反射。 In use, the embodiment allows the ambient light passes through the transparent lens or window in the top housing of the present invention above, the ambient light from the projection arranged concave recessed pocket or the bag close to the window of the window indicator surface reflection. 之后所反射的光通过视窗被传输回来之后由使用者的眼睛接收。 After the light reflected after being transmitted back through the window is received by the user's eye. 本质上,当针歧管处于上部或缩回位置中时,输液装置的指示器视窗作为透明透镜所围绕的明亮目标而出现。 In essence, when the needle manifold at an upper or retracted position, indicator window infusion device around a transparent bright objective lens occurs. 由于与顶部壳体的环境表面具有截然相反的颜色,因此指示器是可视的。 Because the color of the opposite surface of the top of the housing environment, so the indicator is visible.

当针歧管向下时,或处于“套管插入”位置中时,突出的指示器零件距离视窗具有一定距离。 When the needle manifold downward, or in a "cannulation" position, projecting from the window pointer having a distance from the part. 在处于该操作模式下的同时穿过视窗的光线无关地从输液装置中反射并在输液装置内部散射,因此视窗显示为暗色。 At the same time is light in this mode of operation through the window regardless of the reflected and scattered from the infusion device within the infusion device, and therefore appear as dark window. 在这种情况下,本发明的该实施例实际上指示出针歧管和套管的位置,而不是指示出流体是否已部分或完全从输液装置中排出并进入到患者体内。 In this case, the embodiment of the present invention actually indicate the position of the needle manifold and the sleeve, rather than indicative of whether the fluid is discharged partially or completely from the infusion set and into the patient. 然而,使用者也可使用其他使用方法以解释指示器视窗中的可视变化。 However, the user may use other methods used to explain a visual change in the indicator window.

出于方便使用和保护性目的,以上所述的实施例通常是已包装的。 For purposes of convenience and protection, the above-described embodiments are generally packaged. 因此,在本发明的另一个改良实施例中,提供了一种包装系统,所述系统允许诸如以上所述那些可预填装装置无菌化、可输送、防污染,并且填充内容物,诸如液体、气体、粉末等形式的药物。 Accordingly, in another modified embodiment of the present invention, there is provided a packaging system, the system allows such as those described above may be pre-filled sterilized apparatus can be transported, pollution, and the contents are filled, such as in the form of liquids, gases, powders and other drugs. 装置本身并非防污染,但是包装表面是防污染的。 Device itself does not stain, but the package surface is anti-pollution.

图168到175中所示的包装系统包括阵列型包装,或组套1170,所述组套1170将多个可预填装装置1175保持在限定位置中(即,竖直),并且提供可为挠性的外部包装,例如柔软袋1185和1190,或刚性的外部包装,例如箱1180。 The packaging system shown in FIG. 168-175 includes an array type package or stack 1170, 1170 of the stack will be a plurality of pre-filled device 1175 remains in a defined position (i.e., vertical), and may be provided a flexible outer wrapper, such as soft bags 1185 and 1190, or a rigid outer package, for example, box 1180.

在制造出包括以上所述的改良实施例的任何输液装置之后,所述装置可被组装到图168的空组套1170的开口1171中,直到如图169中所示的充满,或者如图170中所示的局部充满。 After the infusion device for producing any of the above embodiments comprises a modified, the device can be assembled to an empty stack 168 of FIG. 11,711,170 in the opening, as shown in FIG filled up with 169 or 170 in FIG. shown partially filled. 每个开口都还包括多个肋1196,如下面更详细地描述的。 Each opening further comprises a plurality of ribs 1196, as described in more detail below. 之后提供了诸如袋1185和袋1190(如示出了完整包装示例的图174中所示的)或盒1180和袋1190(如示出了完整包装示例的图175中所示的)等外部包装,从而保证抵抗细菌污染的完整性。 After providing bags such as bags 1185 and 1190 (as shown in FIG complete a package 174 in the example shown) and a bag or box 1180 1190 (as shown in FIG complete a package 175 in the example shown) or the like outside packaging to ensure the integrity of bacterial contamination resistance. 袋1185可具有内部真空,并且袋1190可具有或不具有内部真空。 Bag 1185 may have an internal vacuum, and the pouch 1190 may or may not have an internal vacuum. 刚性盒1180可具有Tyvek、纸、膜或刚性罩,而袋1190可具有或不具有内部真空。 1180 may have a rigid cartridge Tyvek, paper, a film or a rigid cover, and a pocket 1190 may or may not have an internal vacuum. 通常,外部包装可包含另一个包装,增加该包装以防止灰尘与盒或袋相接触(即,防尘罩)。 Typically, the outer package can contain another package, the package increases to prevent dust or the bag in contact with the cartridge (i.e., dust cover). 可通过γ辐射、环氧乙烷、E射线或其他适当的灭菌方法使得该完整包装(即,组套1170和外部包装)灭菌。 By γ radiation, ethylene oxide, E-rays or other suitable methods of sterilization such that the full package (i.e., stack 1170 and an outer wrapper) sterilized.

当装置1175需要被填充时,从外部消毒完整包装以防微生物进入作为无菌环境的填充室中。 When the apparatus 1175 to be filled from outside the package to prevent complete sterilization of microorganisms into the environment as a sterile filling chamber. 之后外部袋1190(即,防尘罩)被移除并且外部包装的盒或袋(即,1180或1185)被打开以取出组套1170,并且具有装置1175的组套被放置在填充机器(未示出)上,之后填充装置1175。 After the outer bag 1190 (i.e., the dust cover) is removed and the outside of the package box or pouch (i.e., 1180 or 1185) is opened to remove the stack 1170, and 1175 with the device stack is placed in a filling machine (not the illustrated), after the filling apparatus 1175.

为了便于填充程序,填充机器可使用肋1195和1196以及如图173的组套的顶视图中所示的设在组套1170的每个开口1171底部中的大开口1198,如图171中所示的那样升起装置1175。 In order to facilitate the filling procedure, the filling machine 1195 and the ribs 1196 may be used as well as a large opening provided in the bottom of each stack in the opening 11711170 group shown in FIG. 173 sets a top view 1198, 171 shown in FIG. lifting apparatus as 1175. 肋1195和1196以及开口1198被提供得用于改进装置1175周围的层流气流并且如果装置的顶部上需要力的话为装置1175提供支撑。 Ribs 1195 and 1196 and the openings 1198 are provided to give a laminar air flow around the device 1175 is improved and if desired, then the force on top of the device to provide support for the device 1175. 肋1195还可用于保持装置1175而肋1196可用于确定装置的中心。 Rib means 1175 and 1195 may also be used to determine the center rib 1196 of the means for holding. 对于具体填充程序,装置1175需要被保持在正确位置中以使得填充机器(未示出)的填充头与装置1175对齐,如图171中的箭头所示的。 Specific procedures for filling, means 1175 in the correct position so that the filling machine (not shown) of the filling head of the device 1175 to be held aligned, as shown by arrow 171 in FIG. 如图171中所示的那样向上移动装置允许填充机器具有辅助装置以便于仔细地对齐装置1175。 Upwardly as shown in FIG mobile device 171 allows the filling machine having an auxiliary means so that the device 1175 to be carefully aligned.

通常,包装与注射器结合使用,其中注射器被布置在由塑料板和玻璃罩构成的组套中,并且提供了由刚性盒构成的外部包装。 Typically, the packaging used in conjunction with the syringe, wherein the syringe is disposed in a stack consisting of glass and plastic plate, and is provided outer package made of a rigid cassette. 本发明的实施例不包括板和玻璃罩,而仅仅为肋1195和1196的布置。 Embodiments of the present invention does not include a plate and a glass, but only to the ribs 1195 and 1196 are arranged. 肋1195和1196的使用确保了较低的前表面,并且允许层流气流存在于所述室中以在装置1175周围流动,并且除提供以上所述的提升能力以外还改进填充的质量。 Ribs 1195 and 1196 used to ensure that the lower front surface, and allowing the laminar air flow present in the chamber to flow around the device 1175, and the lifting capacity than the other to provide a further improvement of the above fill mass.

与以上所述的实施例相关的其他优点在于,具有作为外部包装的挠性袋1185而不是刚性盒1180,这样允许袋1185中的真空提供包装整体性的可视指示器。 Other advantages associated with the above-described embodiment in that the outside of the package has a flexible bag, rather than a rigid box 1185 1180, 1185 which allows the bag to provide visual indicator of the vacuum package integrity. 在该型式中,失去的真空表示非整体性。 In this version, the loss of vacuum indicates non-integrity. 另外,挠性袋1185比提供盒1180更低廉。 Further, flexible bag 11851180 cheaper than providing cassette. 在优选实施例中,提供了具有组套1170和不具有真空的外部袋1185的结构,以及也不具有真空的增加的第二袋1190,以避免灰尘与第一袋相接触。 In a preferred embodiment, there is provided a structure having a stack 1170 and the outer bag does not have a vacuum of 1185, and a vacuum does not have an increased second pocket 1190 to prevent contact with the first dust bag.

尽管上面仅详细描述本发明的几个实施例,但是本领域中普通技术人员可容易地理解的是,在没有显著背离本发明新颖性技术和优点的前提下在示范性实施例中可作出许多修正。 Although a few of the invention described above are merely detailed embodiments, those skilled in the art can readily appreciate that, under the premise of without significantly departing from the present invention is the novel teachings and advantages of the embodiment in an exemplary embodiment may be that many correction. 因此,所有所述修正都应包含在本发明的保护范围内。 Thus, all of the correction to be included within the scope of the present invention.

Claims (66)

1.一种用于通过患者皮肤注射将药物输入到患者体内的装置,所述装置包括:具有适合于与患者皮肤相接触的底表面、以及顶表面的外壳;适合于刺入组织的注射针,所述针具有管腔;设置在形成腔室的所述外壳内部用于容纳所述药物的容器,所述容器限定了具有纵向轴、容器端部和主体端部的主体开口,以及容器口,其中所述主体开口通过所述容器口与所述腔室流体连通,并且所述主体开口通过设置在主体开口的所述容器端部与所述主体端部之间的针孔与注射针的内腔流体连通;用于当所述装置被启动时为所述腔室加压的加压系统;以及设置在所述主体开口中的阀,具有用于密封所述容器口的容器密封和用于密封所述主体开口的所述主体端部的主体密封,并且可在所述主体开口中的第一和第二位置之间沿所述纵向轴移动;其特征在于,当所述阀 1. A method for injecting a patient the drug through the skin to the input means of the patient, the apparatus comprising: a bottom having a surface adapted for contact with the patient's skin, and the top surface of the housing; adapted for piercing tissue of the injection needle said needle having a lumen; disposed inside the housing forming a chamber for receiving the drug container, the container having a body defining a longitudinal axis, the container end and an opening end of the body, and the container mouth wherein the container body through the opening of the port communicated with the fluid chamber, and the body opening by the injection needle pinhole disposed between said container body having an opening end portion of the end portion of the body in fluid communication with the lumen; means for, when the system is pressurized to start pressurizing of the chamber; and a valve disposed in said body opening, the container having a seal for sealing the container mouth, and with the main body portion to seal the end opening of the sealing body, and can be moved along the longitudinal axis between a first position and a second opening in said body; characterized in that, when the valve 于所述第二位置中时,形成了所述容器口和所述针孔之间的流体连通,从而允许药物从由所述加压系统加压的腔室中通过容器口、通过主体开口、通过针孔、以及通过针的内腔流入到患者体内。 In said second position, forming a fluid communication between the container opening and the pin holes, thereby allowing the pressurized medicament from the system by the pressurized chamber through the container mouth through the body opening, It flows into the patient through the pinhole and through the needle lumen.
2.依照权利要求1中所述的装置,其特征在于,所述主体密封和容器密封是由弹性材料构成的。 2. The apparatus according to claim 1, wherein said container is sealed and the sealing body are made of an elastic material.
3.依照权利要求2中所述的装置,其特征在于,所述主体密封还包括适合于与主体开口的内部干涉配合的多个主体密封环,并且容器密封还包括适合于与主体开口的内部干涉配合的多个容器密封环。 3. The apparatus according to claim 2, wherein said seal body further comprising a plurality of suitable interference fit seal ring body inside the main body opening, and the container further comprises an inner seal adapted to cooperate with the body opening a plurality of containers of an interference fit sealing ring.
4.依照权利要求1中所述的装置,其特征在于,所述阀由活塞部分和止动器部分构成,所述活塞部分外部上的止动器部分形成容器密封和主体密封两者,并且所述止动器部分是由比所述活塞部分更具有挠性的材料制成的。 4. The apparatus according to claim 1, wherein the valve portion is constituted by the piston and the stopper portion, the stopper portion on the outer portion of the piston seal and the body of the container is formed both sealed, and the stopper portion is more flexible than the material of the piston portion made.
5.依照权利要求1中所述的装置,其特征在于,所述主体开口具有锥形部分,所述锥形部分从容器端部延伸到主体端部,并且主体端部具有比所述容器端部更大的相对直径。 5. The apparatus according to claim 1, wherein said body has a tapered opening portion, said tapered portion extending from the end portion of the container body to the end portion and the body portion than the end of the container end relatively larger diameter portion.
6.依照权利要求1中所述的装置,其特征在于,所述主体开口在所述容器端部和所述主体端部之间具有第一部分和第二部分,所述第一部分具有第一直径,所述第二部分具有第二直径,其中所述第一直径小于所述第二直径。 6. The apparatus according to claim 1, wherein said body opening having a first portion and a second portion between the container end and the body end portion, said first portion having a first diameter a second portion having a second diameter, wherein the first diameter is smaller than the second diameter.
7.依照权利要求6中所述的装置,其特征在于,所述第一部分和第二部分之间的过渡部分是渐缩的。 7. The apparatus according to claim 6, characterized in that the transition between the first and second portions are tapered.
8.依照权利要求3中所述的装置,其特征在于,所述容器密封环具有第一直径并且主体密封环具有第二直径,其中所述第一直径小于所述第二直径。 8. The apparatus according to claim 3, wherein said seal ring container body having a first diameter and a second sealing ring having a diameter, wherein the first diameter is smaller than the second diameter.
9.依照权利要求1中所述的装置,其特征在于,所述容器口被设置在所述容器端部处。 9. The apparatus according to claim 1, wherein said container port is provided at the end of the container.
10.依照权利要求1中所述的装置,还包括由腔室、容器口、主体开口、针孔和用于保持流体路径的无菌性的阀装置所限定的流体路径。 10. The apparatus according to claim 1, further comprising an opening from the chamber, the mouth of the container body, and a pinhole fluid path valve means for maintaining sterility of the fluid path defined.
11.一种用于通过患者皮肤注射将药物输入到患者体内的装置,所述装置包括:具有底表面和顶表面的外壳;适合于刺入组织的注射针,所述针具有管腔;设置在所述外壳内部用于容纳所述药物的容器,所述容器具有主体开口;用于当所述装置被启动时为所述容器加压的加压装置;以及可在所述主体开口中的第一和第二位置之间移动的阀装置;所述阀装置包括可移动的止动器,所述止动器在处于第一或第二位置中时保持其完整性;其特征在于,当所述阀装置处于所述第二位置中时,形成了所述容器和所述针之间的流体连通,从而允许药物从由所述加压装置加压的容器中通过针流入到患者体内。 11. A method for injecting a patient the drug through the skin to the input means of the patient, the apparatus comprising: a housing having a top surface and a bottom surface; suitable for penetrating tissue of the injection needle, the needle having a lumen; Settings inside the housing for receiving the drug container, said container body having an opening; pressurizing means for pressurizing the container of the device is activated when the; and may be in the body opening valve means movable between a first and a second position; said valve means comprises a movable stopper, the stopper is in the first or in the second position, retaining its integrity; wherein, when when said valve means is in said second position, forming a fluid communication between the container and the needle, thereby allowing the drug to flow from the pressurizing means by said pressurized container through a needle into the patient.
12.一种用于通过患者皮肤注射将药物输入到患者体内的装置,所述装置包括:具有适合于与患者皮肤相接触的底表面、以及顶表面的外壳;适合于刺入组织的注射针;设置在所述外壳内部适合于容纳所述药物的容器,所述容器具有带有纵向轴的主体开口,并且所述主体开口与注射针选择性地流体连通;适合于为所述容器加压的加压系统;以及设置在所述主体开口中的阀,适于密封限定了第一位置的容器,并且可沿所述纵向轴移动到所述主体开口中的第二位置;其特征在于,当所述阀移动到所述第二位置时,在所述容器和所述针之间形成了流体连通,从而允许药物从由所述加压系统加压的容器中通过针流入到患者体内。 12. A method for injecting a patient the drug through the skin to the input means of the patient, the apparatus comprising: a bottom having a surface adapted for contact with the patient's skin, and the top surface of the housing; adapted for piercing tissue of the injection needle ; disposed inside the housing adapted to receive the medicament container, the container having a body with a longitudinal axis of the opening and the opening of the body with the needle in selective fluid communication; pressurizing said container is adapted to pressurized system; and a valve disposed in said body opening, adapted to seal a container defining a first position and may be moved along the longitudinal axis of the opening to a second position in said body; characterized in that, when the valve is moved to the second position, between the container and the needle forms a fluid communication, thereby allowing the drug to flow from the pressurized container by the pressurized system through the needle into the patient.
13.一种用于通过患者皮肤注射将药物输入到患者体内的装置,所述装置包括:具有底表面以及顶表面的外壳;适合于刺入组织的注射针;设置在所述外壳内部适合于容纳所述药物的容器,所述容器具有与容器流体连通的第一流动路径;适合于为所述容器加压的加压系统;由第一流动路径和第二流动路径限定的流体路径,其中第二流动路径与注射针流体连通;以及设置在所述流体路径中的阀,具有容器密封和流体路径密封,所述容器密封和流体路径密封通过它们之间的阀主体相连接,所述流体路径密封具有与流体路径相接触的内侧以及不与流体路径相接触的外侧,所述容器密封被整体设置在流体路径中并且可在所述流体路径中的第一和第二位置之间移动;其特征在于,当容器密封处于第一位置中时,不允许第一流动路径与第二流动路径之间的流体连 13. A method for injecting a patient the drug through the skin to the input means of the patient, the apparatus comprising: a housing having a top surface and a bottom surface; suitable for penetrating tissue of the injection needle; disposed inside the housing adapted to receiving a medicament container, the container having a first flow path in fluid communication with the container; pressurized vessel adapted to be pressurized of the system; a fluid path defined by the first flow path and second flow path, wherein a second flow path in fluid communication with the injection needle; and a valve disposed in the fluid path, and a sealed fluid path having a sealed container, sealing the container and sealing the fluid path through the valve body is connected therebetween, said fluid path having a sealing contact with the inner and outer fluid paths are not in contact with the fluid path, the sealed container is integrally provided in the fluid path and movable between first and second positions in the fluid path; wherein, when the container is sealed in the first position, do not permit fluid flow path between the first and the second flow path connecting ,而当容器密封处于第二位置中时,允许第一流动路径与第二流动路径之间的流体连通。 , When the container is sealed in the second position, allowing fluid flow between the first communication path and the second flow path.
14.依照权利要求13中所述装置,其特征在于,当容器密封处于第一位置中、第二位置中、或它们之间时,保持了容器密封的整体性。 14. The apparatus in accordance with claim 13, wherein, when the container is sealed in the first position, a second position, or between them, maintaining the integrity of the seal of the container.
15.依照权利要求13中所述的装置,其特征在于,当容器密封处于第一位置中、第二位置中、或它们之间时,流体路径密封的外侧不与流体路径相接触。 15. The apparatus according to claim 13, wherein, when the container is sealed in the first position, a second position, and between them, sealing the fluid path is not in contact with the outer side of the fluid path.
16.一种用于通过患者皮肤注射将药物输入到患者体内的装置,所述装置包括:具有适合于与患者皮肤相接触的底表面、和顶表面的外壳;适合于刺入组织的注射针,所述针具有管腔;设置在外壳内部的容器,所述容器由基本为刚性的板和粘于其上的基本为挠性的隔膜构成,形成用于容纳所述药物的腔室,所述容器具有带有纵向轴、和容器端部、以及主体端部的主体开口,以及所述容器口,其特征在于,所述主体开口通过容器口与所述腔室流体连通,并且所述主体开口通过设置在主体开口的所述容器端部与所述主体端部的针孔与注射针的内腔流体连通;用于通过压制所述隔膜为所述腔室加压的加压系统;以及设置在所述主体开口中的阀,具有用于密封所述容器口的容器密封和用于密封所述主体开口的所述主体端部的主体密封,并且可沿所述纵向轴在 16. A method for injecting a patient the drug through the skin to the input means of the patient, the apparatus comprising: a bottom having a surface adapted for contact with the patient's skin, and a top surface of the housing; adapted for piercing tissue of the injection needle said needle having a lumen; disposed inside the housing container, the container is made substantially of a flexible diaphragm constituting a substantially rigid upper plate and adhered thereto to form a chamber for receiving the drug, the with said container having a longitudinal axis and an end portion of the container body, and the opening end of the body, and the container mouth, wherein the container body through the opening port in fluid communication with the chamber, and the body by opening a lumen in fluid communication with the pinhole provided in the container with the needle end and the body end of the body opening; it means for pressing the diaphragm by pressurizing the chamber to the pressurized system; and a valve body disposed in said opening, the container having a seal for sealing the mouth of the container body and the body for sealing an end portion of the seal body opening and along said longitudinal axis 述主体开口的第一和第二位置之间移动;其特征在于,当所述阀从所述第一位置移动到所述第二位置中时,形成了所述容器口和所述针孔之间的流体连通,从而允许药物从由所述加压系统加压的腔室、通过容器口、通过主体开口、通过针孔、以及通过针的内腔流入到患者体内。 Movable between first and second positions of said body opening; wherein, when the valve is moved from the first position to the second position, forms the mouth of the container and the pinholes the fluid communication between, so as to allow the pressurized medicament from the system by the pressurized chamber, through the container mouth, the opening through the body, through the pinhole, and flows through the lumen of the needle into the patient.
17.依照权利要求16中所述的装置,还包括具有歧管端部和针孔端部的针管,其特征在于,针孔端部与针孔流体连通并且歧管端部与针的内腔流体连通,并且歧管端部适合于容纳针。 17. The apparatus according to claim 16 of the claims, further comprising a needle cannula having a manifold end and the end portion of the pinhole, wherein the pinhole pinhole end portion and a lumen in fluid communication with the manifold end portion of the needle in fluid communication with the manifold adapted to receive an end portion of the needle.
18.依照权利要求16中所述的装置,其特征在于,所述容器基本是平坦的并且基本为环形的。 18. The apparatus according to claim 16 of the claims, characterized in that the container is substantially flat and substantially annular.
19.依照权利要求18中所述的装置,其特征在于,所述针管处于所述容器外围周围的弓形路径中。 19. The apparatus according to claim 18, wherein said needle cannula is in the arcuate path around the periphery of the container.
20.依照权利要求16中所述的装置,其特征在于,所述针管由刚性板整体形成。 20. The apparatus according to claim 16 of the claims, wherein the needle tube is formed of a rigid plate integrally.
21.依照权利要求16中所述的装置,其特征在于,所述针管是由不同于刚性板的材料形成的。 21. The apparatus of claim 16 according to claim, wherein said needle cannula is formed of a material different from a rigid plate.
22.依照权利要求17中所述的装置,其特征在于,所述针管的歧管端部可在第一位置和第二位置之间移动,所述第一位置与处于外壳中的针相对应,所述第二位置与处于外壳外部的针相对应。 22. The apparatus according to claim 17, wherein the manifold end of the needle cannula is movable between a first position and a second position, said first position in the housing corresponding pins , the needle is in the second position corresponds to the outer housing.
23.依照权利要求17中所述的装置,还包括针头接口,其中针头接口适合于保持所述针,并且所述针头接口被刚性地附于所述针管的歧管端部,以使得所述针的内腔与所述针管流体连通。 23. The apparatus according to claim 17, further comprising a needle hub, wherein the needle hub is adapted to hold said needle, and the needle hub is rigidly attached to the manifold end portion of the needle tube, so that the needle lumen is in fluid communication with the needle cannula.
24.依照权利要求22中所述的装置,其特征在于,所述针管是悬臂的以使得当歧管端部处于第一位置中时针管偏斜,而当歧管端部处于第二位置中时针管基本不偏斜,并且针管的歧管端部沿弓形路径从第一位置移动到第二位置。 24. The apparatus according to claim 22, wherein the needle tube is cantilevered position such that when the first hour hand pipe deflection, when the end portion of the manifold in the second position in the manifold end tube manifold end portion does not substantially deflected clockwise, and the needle is moved in an arcuate path from a first position to a second position.
25.依照权利要求19中所述的装置,还包括从所述主体开口突出的针稳定器,所述针稳定器具有附于针管的歧管端部的歧管端部,其特征在于,所述针稳定器处于围绕所述容器周围的弓形路径中,与针管相对。 25. The apparatus according to claim 19, further comprising a pin projecting from said body opening stabilizer, said stabilizer having a needle manifold end portion of the tube attached to the needle manifold end portion, wherein the said needle stabilizer is in the arcuate path around the periphery of the container, opposite the needle.
26.依照权利要求16中所述的装置,其特征在于,所述加压系统为适合于压缩所述隔膜的盘簧。 26. The apparatus of claim 16 according to claim, wherein said pressing plate spring system is adapted to compress the diaphragm.
27.依照权利要求16中所述的装置,其特征在于,所述加压系统为适合于压缩所述隔膜的贝式弹簧。 27. The apparatus of claim 16 according to claim, wherein said pressurized Belleville system is adapted to compress the diaphragm.
28.依照权利要求22中所述的装置,其特征在于,所述针管是悬臂的以使得当歧管端部处于第一位置中时针管偏斜,而当歧管端部处于第二位置中时针管比第一位置中时较少偏斜,并且针管的歧管端部沿基本为弓形的路径从第一位置移动到第二位置。 28. The apparatus according to claim 22, wherein the needle tube is cantilevered position such that when the first hour hand pipe deflection, when the end portion of the manifold in the second position in the manifold end clockwise than the first tube is less deflected position, the needle tube and the end portion of the manifold along a substantially arcuate path of movement from a first position to a second position.
29.依照权利要求22中所述的装置,其特征在于,所述针管是悬臂的以使得当歧管端部处于第一位置中时针管具有第一势能,而当歧管端部处于第二位置中时针管具有第二势能,并且第一势能大于第二势能。 29. The apparatus according to claim 22, wherein the needle tube is cantilevered such that when the manifold is in the first position, the end portion has a first potential hour, and when in the second manifold end portion the hour tube has a second position, the potential energy, and the first potential is greater than the second potential.
30.依照权利要求22中所述的装置,还包括连接于针管的针启动弹簧,其中当歧管端部处于第一位置中时针启动弹簧具有第一势能,而当歧管端部处于第二位置中时针启动弹簧具有第二势能,并且第一势能大于第二势能。 30. The apparatus according to claim 22, further comprising a tube connected to the needle start spring, wherein when an end portion of the manifold in a first position having a first spring clockwise starting potential, and when the manifold is in the second end portion hour starting position the spring has a second potential, the first potential and higher than the second potential.
31.一种用于通过患者皮肤注射将药物输入到患者体内的装置,所述装置包括:具有底表面和顶表面以及纵向轴的外壳;适合于刺入组织的注射针;设置在所述外壳内部的容器,形成用于容纳所述药物的腔室,所述容器选择性地与注射针流体连通;盘簧,具有中央孔,并且选择性地、可操作地与容器相接合;以及设置在所述外壳中的启动元件,具有第一端和第二端以及纵向轴,所述第二端具有适合于从盘簧的中央孔中插入和移除的销,所述启动元件具有其中销被设置在盘簧的中央孔中的第一位置和其中销从盘簧的中央孔中移除的第二位置;其特征在于,所述启动元件通过移除力的施加移动到所述第二位置中。 31. A method for injecting a patient the drug through the skin to the input means of the patient, the apparatus comprising: a housing having a top surface and a bottom surface and a longitudinal axis; suitable for penetrating tissue of the injection needle; is provided in the housing inside the container, forming a chamber for containing the medicament, said container selectively in fluid communication with the injection needle; coil spring having a central aperture and selectively operable to engage with the container; and provided promoter element in the housing having a first end and a second end and a longitudinal axis, said second end having a central hole adapted to be inserted from the coil spring and the pin removed, the actuating element having a pin which is a first pin and second positions from a central hole in the disc spring in a central bore wherein a removable disk spring in; wherein said moving member starts by removing the force applied to said second position in.
32.依照权利要求31中所述的装置,其特征在于,当启动元件处于第二位置中时,允许所述盘簧为所述容器加压,从而将药物排出到针中并进入到患者体内。 32. The apparatus according to claim 31, wherein, when the start element in the second position, allow said coil spring to said pressure container so as to expel the medicament into the needle and into the patient .
33.依照权利要求31中所述的装置,其特征在于,所述容器由基本为刚性的板和粘于其上的基本为挠性的隔膜构成。 33. The apparatus according to claim 31, wherein said container is made of a substantially flexible diaphragm constituting a substantially rigid plate and adhered thereon.
34.依照权利要求31中所述的装置,其特征在于,所述销至少部分地通过摩擦被保持在盘簧的中央孔中。 34. The apparatus according to claim 31, characterized in that the pin is at least partially held in the central aperture of the disc spring by friction.
35.依照权利要求31中所述的装置,还包括设在与盘簧相接合的销上的制动部分。 35. The apparatus according to claim 31, further comprising a brake portion provided on the coil spring engaged with the pin.
36.依照权利要求35中所述的装置,其特征在于,销和制动器是分段的,从而减小将销从盘簧的中央孔中移除所需的移除力。 36. The apparatus according to claim 35, characterized in that the pin and the brake is segmented to reduce the removal force required to remove the pin from the center hole of the disc springs.
37.依照权利要求34中所述的装置,其特征在于,销是分段的,从而减小将销从盘簧的中央孔中移除所需的移除力。 37. The apparatus according to claim 34, characterized in that the pin is segmented, thereby reducing the removal force required to remove the pin from the center hole of the disc springs.
38.依照权利要求31中所述的装置,还包括设置在启动元件的所述第一端和所述第二端之间的支点,从而将启动元件形成为杠杆,其中施加在启动元件的第一端上的第一力通过启动元件被传输以产生将销从盘簧中移除所需的移除力。 38. The apparatus according to claim 31, further comprising a fulcrum member disposed between the first starting end and the second end, so that the starting element is formed as a lever, which is applied at the start of the element the first force is transmitted through the upper end of the starting member to produce the removal force required to remove the pin from the spiral spring.
39.依照权利要求38中所述的装置,还包括在基本平行于启动元件纵向轴的路径中可移动的按钮,所述按钮具有斜面,所述斜面与启动元件的第一端相接合,从而所述斜面形成启动元件的第一端被接合在其上的倾斜平面,并且斜面朝向启动元件的移动在启动元件的第一端上施加反作用力,所述反作用力通过启动元件被传输以产生将销从盘簧中移除所需的移除力。 39. The apparatus according to claim 38, further comprising movable in a path substantially parallel to the longitudinal axis of the actuating element of the button, the button has an inclined surface, said inclined surface and a first end engaging the actuating element, whereby the ramp forming a first inclined plane start element end is bonded thereon, and the ramp element moves towards the start of the reaction force exerted on the first end of the actuating element, the reaction force is transmitted through the starting member to produce the removal force required to remove the pin from the spiral spring.
40.依照权利要求38中所述的装置,其特征在于,支点被设置在启动元件上。 40. The apparatus according to claim 38, wherein the fulcrum member is provided on the boot.
41.依照权利要求40中所述的装置,其特征在于,支点被设置在启动元件上并且与所述盘簧相接合。 41. The apparatus according to claim 40, characterized in that the fulcrum is disposed on the actuating element and engages with said coil spring.
42.依照权利要求40中所述的装置,其特征在于,支点沿弓形路径被设置。 42. The apparatus according to claim 40, characterized in that the fulcrum is disposed along an arcuate path.
43.依照权利要求42中所述的装置,其特征在于,支点沿盘簧的径向部分被设置在至少20度处。 43. The apparatus according to claim 42, wherein the fulcrum portion of the radial direction of the disc spring is provided at at least 20 degrees.
44.依照权利要求40中所述的装置,其特征在于,支点被设在启动元件的第二端与启动元件的第一和第二端之间的中点之间。 44. The apparatus according to claim 40, characterized in that the fulcrum is disposed between the midpoint between the first end and the second end of the second actuating element of the actuating element.
45.依照权利要求42中所述的装置,其特征在于,所述盘簧具有多个从盘簧的中央孔延伸的径向气孔,并且支点被径向设置以使得其跨越至少一个气孔。 45. The apparatus according to claim 42, wherein said coil spring having a plurality of air holes radially extending from the central hole of the coil spring, and the fulcrum being disposed radially such that it spans at least a hole.
46.一种用于通过患者皮肤注射将药物输入到患者体内的装置,所述装置包括:具有适合于与患者皮肤相接触的底表面和在装置使用期间可由患者观察的顶表面以及纵向轴的外壳;适合于刺入组织的注射针;设置在所述外壳内部的容器,形成用于容纳所述药物的腔室,所述容器与注射针流体连通;盘簧,具有第一和第二侧面、中央部分和从盘簧的中央部分延伸的至少一个径向气孔,其中所述盘簧具有开始位置,以及终止位置;以及弹簧罩,弹簧罩从中央部分径向延伸并且基本覆盖盘簧至少第一侧上的盘簧中的至少一个气孔。 46. ​​A method for injecting a drug through the skin of the patient to the input apparatus patient, the apparatus comprising: a bottom having a surface adapted for contact with the patient's skin and a top surface as viewed by the patient during use of the device and a longitudinal axis a housing; adapted for piercing tissue of the injection needle; container disposed in the interior of the housing, forming a chamber for receiving the drug, the injection needle is in fluid communication with the container; coil spring having first and second sides , from a central portion and at least one radial hole extending central portion of the coil spring, wherein said coil spring having a start position and an end position; and a spring housing, a spring cover portion extending radially from a central and substantially covering at least a first coil spring at least one hole on the side of the coil spring in.
47.依照权利要求46中所述的装置,其特征在于,所述容器由基本为刚性的板和粘于其上的基本为挠性的隔膜构成,并且弹簧罩与挠性隔膜相接触。 47. The apparatus according to claim 46, wherein said container is made of a substantially rigid plate and adhered thereto a flexible diaphragm constituting substantially, and the spring cover in contact with the flexible membrane.
48.依照权利要求47中所述的装置,其特征在于,所述弹簧罩由弹性材料构成。 48. The apparatus according to claim 47, characterized in that said spring housing is made of an elastic material.
49.依照权利要求47中所述的装置,其特征在于,所述弹簧罩适于与刚性板的几何形状相配,从而当盘簧处于第二位置中时消除容器中的死角。 49. The apparatus according to claim 47, characterized in that said spring housing is adapted to mate with the geometry of the rigid plate, so that when the coil spring is in the second position to eliminate the dead space in the container.
50.依照权利要求47中所述的装置,其特征在于,所述刚性板由基本透明的材料构成。 50. The apparatus according to claim 47, wherein the rigid plate is made of a substantially transparent material.
51.依照权利要求50中所述的装置,其特征在于,所述弹簧罩由弹性材料构成。 51. The apparatus according to claim 50, characterized in that said spring housing is made of an elastic material.
52.依照权利要求51中所述的装置,还包括设置在弹簧罩上的至少一个指示突出部分,其中当盘簧处于开始位置中时,指示突出部分与挠性隔膜相接触并且在挠性隔膜中形成压痕,可通过刚性板看到所述压痕,当盘簧处于终止位置中时,指示突出部分所形成的压痕被刚性板压制并且通过刚性板看不到所述压痕。 52. The apparatus according to claim 51, further comprising a spring disposed at least one indication cover projecting portion, wherein when the coil spring in a starting position, in contact with the projecting portion indicating the flexible diaphragm and the flexible diaphragm forming indentations, the indentations can be seen through the rigid plate, when the coil spring is in the end position, the rigid plate is pressed indicating indentations projecting portion formed by the indentation and can not see the rigid plate.
53.依照权利要求52中所述的装置,其特征在于,至少一个指示突出部分为多个突出部分。 53. The apparatus according to claim 52, characterized in that the at least one indication of the plurality of projecting portions projecting portion.
54.依照权利要求53中所述的装置,其特征在于,所述多个突出部分形成标记,从而指示出装置的状态。 54. The apparatus according to claim 53, wherein said plurality of projecting portions are formed mark, indicating the status of the device.
55.一种用于通过患者皮肤注射将药物输入到患者体内的装置,所述装置包括:具有适合于与患者皮肤相接触的底表面和具有观察窗的顶表面的外壳;适合于刺入组织的注射针;设置在所述外壳内部的容器,由基本为透明材料的顶部隔膜和粘接于其上的基本为挠性的隔膜构成,形成用于容纳所述药物的腔室,所述容器与注射针流体连通;压力产生系统,具有容器接触表面,其中压力产生系统具有开始位置以及终止位置,所述容器接触表面具有弹性部分;以及设置在弹性部分上的至少一个指示突出部分,其中当压力产生系统处于开始位置中时,指示突出部分与挠性隔膜相接触并且在挠性隔膜中形成压痕,可通过顶部隔膜以及通过观察窗看到所述压痕,而当压力产生系统处于终止位置中时看不到所述压痕。 55. A method for injecting a patient the drug through the skin to the input means of the patient, the apparatus comprising: a bottom having a surface adapted for contact with the patient's skin and a top surface of the housing has a viewing window; suitable for puncturing tissue injection needle; container disposed inside the housing, from the top of the separator a substantially transparent material and the adhesive thereon substantially flexible membrane configured to form a chamber for receiving the drug, the container in fluid communication with an injection needle; pressure generating system, the vessel having a contact surface, wherein the pressure generating system having a start position and an end position, said container having a resilient contact surface portion; elastic portion disposed on at least one indication projecting portion, wherein when pressure generating system is in the start position, the projection portion indicating contact with the flexible diaphragm and the flexible diaphragm is formed in the indentation in the top separator, and can be seen by the indentation through the viewing window, and when the pressure generating system is terminated see position when the indentation.
56.依照权利要求55中所述的装置,其特征在于,由指示突出部分所形成的压痕被顶部隔膜压制并且通过顶部隔膜看不到所述压痕,从而指示出压力产生系统处于第二位置中。 56. The apparatus according to claim 55, characterized in that the indentation indicated by the projecting portion is formed on top of the membrane and do not see the indentation pressed through the top membrane, thereby indicating that a second pressure generating system is location.
57.依照权利要求55中所述的装置,其特征在于,至少一个指示突出部分为多个突出部分。 57. The apparatus according to claim 55, wherein the at least one indication of the plurality of projecting portions projecting portion.
58.依照权利要求57中所述的装置,其特征在于,所述多个突出部分形成标记,从而指示出装置的状态。 58. The apparatus according to claim 57, wherein said plurality of projecting portions are formed mark, indicating the status of the device.
59.一种用于通过患者皮肤注射将药物输入到患者体内的装置,所述装置包括:具有适合于与患者皮肤相接触的底表面、底表面中的针孔,以及顶表面的外壳;适合于刺入组织的注射针;设置在所述外壳内部的容器,形成用于容纳所述药物的腔室,以及枢轴,所述容器与注射针流体连通;加压系统,用于为容器加压;以及设置在外壳中用于保持容器的枢转机构,所述枢转机构允许容器在外壳中关于枢轴旋转,所述枢转机构具有其中注射针处于外壳中的第一位置,和其中注射针从所述针孔中从外壳伸出的第二位置;其特征在于,所述枢转机构从所述第一位置移动到所述第二位置,所述加压系统可为容器加压,从而将药物排出到针中并进入到患者体内。 59. A method for injecting a drug through the skin of the patient to the input apparatus patient, the apparatus comprising: a bottom having a surface adapted for contact with the skin of the patient, the bottom surface of the pinhole, and a top surface of the housing; for needle penetration in the tissue; container disposed in the interior of the housing, forming a chamber for containing the drug, and a pivot, the injection needle is in fluid communication with the container; pressurizing system for a container plus pressure; and a pivoting mechanism is provided for holding the container in the housing, the pivot mechanism allows rotation of the container about a pivot in the housing, the pivot mechanism having a first position wherein the needle is in the housing, and wherein the second position of the needle from a pinhole extending from the housing; wherein the pivot mechanism is moved from the first position to the second position, the pressurized container may be pressurized system to expel medicament into the needle and into the patient.
60.一种用于通过患者皮肤注射将药物输入到患者体内的装置,所述装置包括:具有适合于与患者皮肤相接触的底表面、以及顶表面的外壳;适合于刺入组织的注射针,所述针具有内腔;设置在所述外壳内部的容器,形成用于容纳所述药物的腔室,所述容器具有带有纵向轴和容器端部以及主体端部的主体开口,以及容器口,其中,所述主体开口利用容器口与所述腔室流体连通,并且所述主体开口通过设置在所述主体开口的所述容器端部与所述主体端部之间的针孔与注射针的内腔流体连通;加压系统,当装置被启动时用于为所述腔室加压;以及设置在所述主体开口中的可旋转的阀,具有用于密封所述容器口的容器密封和用于密封所述主体开口的主体端部的主体密封,以及设置在它们之间的流体沟槽,所述阀可关于所述纵向轴在所述主体开口中在第一和 60. A method for injecting a patient the drug through the skin to the input means of the patient, the apparatus comprising: a bottom having a surface adapted for contact with the patient's skin, and the top surface of the housing; adapted for piercing tissue of the injection needle said needle having a lumen; container disposed inside the housing, forming a chamber for containing the medicament, the container having a body with a longitudinal axis of the body and the container end and the opening end portion, and a container mouth, wherein the container body opening using port in fluid communication with the chamber, and the body of the injection opening between the pinhole end of the container body through an opening provided in the end portion of the body in fluid communication with the lumen of the needle; pressurization system for pressurization of the chamber when the device is actuated; and a main body disposed in the opening of the rotatable valve, a container for sealing the mouth of the container and a sealing body for sealing the end portion of the body opening seal body, and a fluid channel disposed therebetween, the valve rotatable about said longitudinal axis of said body at a first opening and 二位置之间旋转;其特征在于,所述阀可从第一位置旋转到所述第二位置,通过阀上的流体沟槽在所述容器口和所述针孔之间形成流体连通,从而允许药物从由所述加压系统加压的腔室、通过容器口、通过流体沟槽、通过针孔、以及通过针的内腔流入到患者体内。 Rotation between the two positions; characterized in that the valve can, by means of a valve on the fluid channel in fluid communication from the first position to the second position between the container mouth and the pinhole, so that allowing drug from the system is pressurized by the pressurization chamber, through the container mouth, through the fluid channel, through the pinhole, and flows into the patient through the lumen of the needle.
61.依照权利要求60中所述的装置,其特征在于,所述主体密封和容器密封是由弹性材料制成的。 61. The apparatus of claim 60 according to claim, wherein said body seal and sealed container are made of an elastic material.
62.依照权利要求61中所述的装置,其特征在于,所述主体密封还包括适合于与主体开口的内部干涉配合的多个主体密封环。 62. The apparatus of claim 61 according to claim, wherein said seal body further comprises a plurality of bodies for an interference fit with the interior of the body opening in a sealing ring.
63.依照权利要求60中所述的装置,其特征在于,所述阀包括活塞部分和止动器部分,所述止动器部分位于所述活塞部分外部之上,形成所述主体密封和容器密封两者,并且所述止动器部分是由比所述活塞部分更具挠性的材料构成。 63. The apparatus according to claim 60, characterized in that the valve piston and the stopper portion includes a portion, the stopper portion being located above the outer piston portion, said body is formed and sealed container both sealed, and the stopper portion is made more flexible than the material of the piston portion.
64.依照权利要求60中所述的装置,其特征在于,所述主体开口具有锥形,所述锥形从容器端部延伸到主体端部,并且主体端部具有比所述容器端部大的相对直径。 64. The apparatus according to claim 60, characterized in that said body has a tapered opening, said tapered portion extending from the end of the container body to the end and the body end portion having an end portion than the large container the relative diameters.
65.依照权利要求60中所述的装置,其特征在于,所述主体开口在所述容器端部和所述主体端部之间具有第一部分和第二部分,所述第一部分具有第一直径,所述第二部分具有第二直径,其中所述第一直径小于所述第二直径。 65. The apparatus according to claim 60, characterized in that said body opening having a first portion and a second portion between the container end and the body end portion, said first portion having a first diameter a second portion having a second diameter, wherein the first diameter is smaller than the second diameter.
66.依照权利要求65中所述的装置,其特征在于,所述第一部分和第二部分之间的过渡部分是渐缩的。 66. The apparatus according to claim 65, characterized in that the transition between the first and second portions are tapered.
CN 200480029220 2003-08-12 2004-08-12 Patch-like infusion device CN100509069C (en)

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