CN1871042A - Internal fluid connector - Google Patents

Abstract

Translated fromChinese

提供一种包括储罐和泵组件的医疗器械，该储罐适于在其内部容纳流体药品。泵组件包括泵进口、泵出口及布置它们之间的内部流动通道、及具有进口和出口的流体连接器。该流体连接器布置成从初始状态和致动状态操作，在该初始状态下，流体连接器布置在泵的内部，在该致动状态下，在储罐的内部与泵组件的内部之间经由流体连接器建立流体连通，并且使流体连接器的出口布置在泵组件的流动通道中。

A medical device is provided that includes a reservoir adapted to contain a fluid drug therein and a pump assembly. The pump assembly includes a pump inlet, a pump outlet and an internal flow channel disposed therebetween, and a fluid connector having the inlet and outlet. The fluid connector is arranged to operate from an initial state, in which the fluid connector is disposed inside the pump, and an actuated state, between the interior of the reservoir and the interior of the pump assembly via A fluid connector establishes fluid communication and has an outlet of the fluid connector disposed in the flow channel of the pump assembly.

Description

Translated fromChinese

内部流体连接器internal fluid connector

技术领域technical field

本发明一般涉及一种包括适于彼此流体连通的泵组件和储罐的医疗器械。The present invention generally relates to a medical device comprising a pump assembly and a reservoir adapted to be in fluid communication with each other.

背景技术Background technique

在本发明的公开中，最经常地提到通过胰岛素的注射或输注治疗糖尿病，然而，这仅仅是本发明的典型使用。In the disclosure of the present invention, the treatment of diabetes by injection or infusion of insulin is most often mentioned, however, this is only a typical use of the present invention.

用来把药品输送给病人的可携带药品输送器械是熟知的，并且一般包括适于包含液体药品并具有与空心输液针流体连通的出口的储罐、以及用来从储罐和经空心针穿过对象的皮肤而排出药品的排出装置。这样的器械常常称作输液泵(infusion pump)。Portable drug delivery devices for delivering drugs to patients are well known and generally include a reservoir adapted to contain liquid drug and having an outlet in fluid communication with a hollow infusion needle, and a A discharge device that discharges a drug through a subject's skin. Such devices are often referred to as infusion pumps.

基本上，输液泵可划分成两类。第一类包括是打算用3-4年的比较昂贵的泵的输液泵，为此原因用于这样一种泵的初始成本常常是这种类型疗法的障碍。尽管比传统注射器和笔复杂，但该泵提供胰岛素的连续注射、剂量准确及选择性可编程输送分布的优点，并且用户与膳食联系致动药团注射。Basically, infusion pumps can be divided into two categories. The first category includes infusion pumps which are relatively expensive pumps intended to be used for 3-4 years, for which reason the initial cost for such a pump is often a barrier to this type of therapy. Although more complex than conventional syringes and pens, the pump offers the advantages of continuous injection of insulin, dose accuracy and selectively programmable delivery profiles, and user-actuated bolus injection in connection with meals.

为了解决以上问题，已经进行了几种尝试，以提供成本低和使用便利的第二类药品输注器械。这些器械旨在部分或全部一次性的，并且可以提供与输液泵有关的多种优点而没有附带的成本和不便，例如，泵可以预填充，因而避免对于填充或重新填充药品储罐的需要。这种类型的输注器械的例子从美国专利4,340,048和4,552,561(基于渗透泵)、美国专利5,858,001(基于活塞泵)、美国专利6,280,148(基于隔膜泵)、美国专利5,957,895(基于限流器泵(也称作放出孔泵))、美国专利5,527,288(基于气体产生泵)、或美国专利5,814,020(基于可膨胀胶)得知，这些专利都是为了在便宜的、基本上一次性的药品输注器械中使用而在最近几十年提出的，引用的文件通过参考而包括。美国专利6,364,865公开了一种手持输注器械，它允许两个小瓶型容器连接并在容器之一中建立压力，由此排出在容器中包含的药品。In order to solve the above problems, several attempts have been made to provide a second type of drug infusion device which is low cost and convenient to use. These devices are intended to be partially or fully disposable, and may offer many of the advantages associated with infusion pumps without the attendant cost and inconvenience, for example, the pumps may be prefilled, thus avoiding the need to fill or refill drug storage tanks. Examples of infusion devices of this type are derived from US Patents 4,340,048 and 4,552,561 (based on osmotic pumps), US Patent 5,858,001 (based on piston pumps), US Patent 6,280,148 (based on diaphragm pumps), US Patent 5,957,895 (based on restrictor pumps (also based on known as bleed pumps)), US Patent 5,527,288 (based on gas generating pumps), or US Patent 5,814,020 (based on expandable glue), all of which are intended for use in inexpensive, essentially disposable drug infusion devices As used and proposed in recent decades, cited documents are incorporated by reference. US Patent 6,364,865 discloses a hand-held infusion device which allows two vial-type containers to be connected and build up pressure in one of the containers, thereby expelling the drug contained in the container.

一次性泵一般包括适于通过粘合装置施加到对象的皮肤上的皮肤接触安装表面，并且使输液针布置成，在使用的情形下，它从安装表面伸出，由此透入对象的皮肤，借此在器具处于使用中的同时覆盖其中针透入皮肤的地方。输液针可以布置成永久地从安装表面伸出，从而针借助于输液泵的施加同时插入，这就像在美国专利2,605,765、4,340,048和在EP 1 177 802中公开的那样，针可以装备有处于缩回状态的器械，即，使针的远尖端“隐藏”在泵器械内，这允许用户把泵器械放置在皮肤上而可能没有观察到针，这就像在美国专利5,858,001和5,814,020中公开的那样。除泵之外，可以使用用来传输流体药品的可选择装置，例如下面所讨论的离子电渗疗法。The disposable pump generally includes a skin-contacting mounting surface adapted to be applied to the skin of a subject by adhesive means, and the infusion needle is arranged so that, in use, it protrudes from the mounting surface, thereby penetrating the subject's skin , whereby the place where the needle penetrates the skin is covered while the appliance is in use. The infusion needle can be arranged to protrude permanently from the mounting surface so that the needle is simultaneously inserted by means of the application of the infusion pump, as disclosed in U.S. Patents 2,605,765, 4,340,048 and in EP 1 177 802. Devices that are in the back state, i.e., have the distal tip of the needle "hidden" within the pump device, which allows the user to place the pump device on the skin without possibly seeing the needle, as disclosed in U.S. Patent Nos. 5,858,001 and 5,814,020 . In addition to pumps, alternative devices for delivering fluid medications may be used, such as iontophoresis, discussed below.

尽管可能期望以上描述的第二类完全或部分一次性注射装置可比传统耐用输液泵显著较便宜地制造，但由于太贵而不能用作日常使用的传统输液泵的真正替代物。While it might be expected that the second class of fully or partially disposable injection devices described above could be manufactured significantly less expensive than conventional durable infusion pumps, they are too expensive to be used as a true replacement for conventional infusion pumps for everyday use.

发明内容Contents of the invention

考虑到以上确认的问题，本发明的目的在于提供一种皮肤可安装药品输送器械或系统以及用于它的元件，这些元件允许这样一种器械或系统以便利和成本有效的方式使用。系统和元件的构造因此应该有助于提供一种允许容易和迅速操作而使用可靠的医疗输送装置。In view of the problems identified above, it is an object of the present invention to provide a skin mountable drug delivery device or system and elements therefor which allow such a device or system to be used in a convenient and cost effective manner. The configuration of the system and elements should thus help to provide a reliable medical delivery device allowing easy and quick handling.

在本发明的公开中，将描述实现以上目的的一个或多个的、或者将实现由下面的公开以及由典型实施例的描述成为显然的目的的实施例和方面。In the disclosure of the present invention, embodiments and aspects that achieve one or more of the above objects, or that will achieve objects apparent from the following disclosure and from the description of typical embodiments will be described.

因而，与第一方面相对应，提供一种包括储罐和泵组件的医疗器械，该储罐适于在其内部容纳流体药品。泵组件包括泵进口、泵出口及布置它们之间的内部流动通道。泵组件还包括流体连接器，该流体连接器包括进口和出口，其中流体连接器布置成从初始状态和致动状态操作，在该初始状态下，流体连接器布置在泵的内部，在该致动状态下，在储罐的内部与泵组件的内部之间经流体连接器建立流体连通，并且使流体连接器的出口布置在泵组件的流动通道中。以这种方式，泵组件设有用来把泵组件连接到储罐上的内置可致动装置。Accordingly, corresponding to the first aspect, there is provided a medical device comprising a tank adapted to contain a fluid drug therein and a pump assembly. The pump assembly includes a pump inlet, a pump outlet and an internal flow channel disposed therebetween. The pump assembly also includes a fluid connector including an inlet and an outlet, wherein the fluid connector is arranged to operate from an initial state, where the fluid connector is disposed inside the pump, and an actuated state. In a dynamic state, fluid communication is established between the interior of the storage tank and the interior of the pump assembly through the fluid connector, and the outlet of the fluid connector is arranged in the flow channel of the pump assembly. In this way, the pump assembly is provided with built-in actuatable means for connecting the pump assembly to the tank.

流体致动器可以由布置在泵组件内或外的任何适当装置致动。例如，泵组件可以包括允许外部部件与流体连接器接合由此从初始到致动状态操作流体连接器的致动开口，或者流体连接器可以由装在泵组件内的电气装置释放或致动。The fluid actuator may be actuated by any suitable device arranged inside or outside the pump assembly. For example, the pump assembly may include an actuation opening that allows an external component to engage the fluid connector thereby operating the fluid connector from an initial to an actuated state, or the fluid connector may be released or actuated by an electrical device housed within the pump assembly.

在典型实施例中，泵进口和泵出口及如果提供的致动开口包括在初始状态下密封泵的内部并由此把流动通道和流体连接器密封在初始无菌状态下的密封件。密封件可以是任何适当类型的，例如在已经施加密封件之后允许灭菌气体穿过它们的气体可穿过密封件。在使用辐射来给器械灭菌的情况下，也可以使用对于气体不可穿过的密封件。In typical embodiments, the pump inlet and pump outlet and, if provided, the actuation opening comprise seals which in the initial state seal the interior of the pump and thereby seal the flow channels and fluid connectors in an initial sterile state. The seals may be of any suitable type, for example gas permeable seals allowing a sterile gas to pass through them after the seals have been applied. If radiation is used to sterilize the instrument, a seal impermeable to gas can also be used.

流体连接器可以包括尖的进口端，并且储罐可以包括允许尖的流体连接器进口端穿过其插入的可透过部分。优选地，储罐的可透过部分包括自密封针可透过膜，例如由橡胶材料或弹性化合物制成。对应地，泵出口可以包括允许尖的经皮器械插入穿过的自密封针可透过膜。The fluid connector may include a pointed inlet end, and the reservoir may include a permeable portion that allows the pointed fluid connector inlet end to be inserted therethrough. Preferably, the permeable part of the tank comprises a self-sealing needle permeable membrane, eg made of rubber material or an elastomeric compound. Correspondingly, the pump outlet may comprise a self-sealing needle-permeable membrane to allow insertion of a pointed percutaneous instrument therethrough.

泵组件可以处于例如与电子控制致动装置相结合的机械泵(例如，隔膜泵、活塞泵或滚子泵)、机械驱动泵(例如，由弹簧驱动)、气体驱动泵或由渗透引擎驱动的泵的形式。在典型实施例中，流动通道包括可变体积泵腔室，流动通道优选地还包括与泵进口相联的进口阀和与泵出口相联的出口阀。The pump assembly can be, for example, a mechanical pump (e.g., a diaphragm, piston, or roller pump), a mechanically driven pump (e.g., driven by a spring), a gas-driven pump, or an osmotic engine driven pump in combination with an electronically controlled actuation device. pump form. In typical embodiments, the flow channel includes a variable volume pump chamber, and the flow channel preferably also includes an inlet valve associated with the pump inlet and an outlet valve associated with the pump outlet.

在典型实施例中，医疗器械还包括适于透过对象的皮肤的经皮器械(例如，包括尖端)，经皮器械布置成或适于布置成与泵出口流体连通。In typical embodiments, the medical device further comprises a percutaneous device (eg, comprising a tip) adapted to penetrate the skin of a subject, the percutaneous device being arranged or adapted to be arranged in fluid communication with the pump outlet.

在本发明的上下文中，经皮器械(该术语也覆盖类似术语，在本技术领域中传统使用的经皮接近器械和经皮接近工具)可以为尖空心输液针的形式，显微针阵列、或本身比较柔软的钝插管与尖插入针的组合可以提供尖经皮器械，插入针在经皮器械的钝部分插入之后是可缩回的。在后一种情况下，实际由本发明的缩回装置缩回的经皮器械的部分不必包括允许组合经皮器械穿过皮肤插入的尖端，这样一种尖端在经皮器械的插入期间退回。插管优选地相对于典型地是固体钢针的插入针是软的和柔性的。在本发明的公开中以及在典型实施例的描述中，最经常地提到输液针形式的经皮器械。经皮器械的长度可以按照实际用途选择，例如，相对于皮肤表面可以以大体直角插入的空心钢针可以具有2-8mm，优选地3-5mm的插入长度，而相对于皮肤表面也可以以倾斜角度插入的插管可以稍长，例如4-20mm。In the context of the present invention, a percutaneous device (this term also covers similar terms, percutaneous access device and percutaneous access tool as traditionally used in the art) may be in the form of a pointed hollow infusion needle, an array of microneedles, Or a combination of a blunt cannula which is inherently soft and a pointed insertion needle can provide a pointed percutaneous device which is retractable after insertion of the blunt part of the percutaneous device. In the latter case, the part of the percutaneous device which is actually retracted by the retraction means of the present invention does not have to comprise a tip allowing the insertion of the combined percutaneous device through the skin, such a tip being retracted during insertion of the percutaneous device. The cannula is preferably soft and flexible relative to the insertion needle, which is typically a solid steel needle. In the disclosure of the invention and in the description of typical embodiments, reference is most often made to percutaneous devices in the form of infusion needles. The length of the percutaneous instrument can be selected according to the actual use. For example, a hollow steel needle that can be inserted at a substantially right angle with respect to the skin surface can have an insertion length of 2-8mm, preferably 3-5mm, and can also be inclined with respect to the skin surface. Angled cannulas can be slightly longer, for example 4-20mm.

在另外典型实施例中，本发明提供一种包括上述医疗器械的医疗组件，该医疗组件还包括经皮器械单元，该经皮器械单元具有：经皮器械，包括适于透入对象的皮肤的尖端；和安装表面，适于施加到对象的皮肤上，其中经皮器械单元和医疗器械适于在使用的情形下彼此固定，并且其中经皮器械适于布置成与泵出口流体连通。当经皮器械单元和医疗器械彼此固定时，可以建立在经皮器械与泵组件之间的流体连通，就像当经皮器械单元和医疗器械彼此固定时流体连接器可以从初始到致动状态操作那样。In another exemplary embodiment, the present invention provides a medical assembly comprising the above medical device, the medical assembly further comprising a percutaneous device unit having: a percutaneous device comprising a a tip; and a mounting surface adapted to be applied to the skin of a subject, wherein the percutaneous device unit and the medical device are adapted to be secured to each other in a situation of use, and wherein the percutaneous device is adapted to be arranged in fluid communication with the pump outlet. When the percutaneous device unit and the medical device are secured to each other, fluid communication between the percutaneous device and the pump assembly can be established, just as the fluid connector can be brought from the initial to the actuated state when the percutaneous device unit and the medical device are secured to each other Operate like that.

对应于另一个方面，提供包括经皮单元和储罐单元的医疗器械，其中经皮单元包括用来穿过对象的皮肤部分传送流体的经皮装置、和适于施加到对象的皮肤上的安装表面。储罐单元包括：储罐，适于容纳流体药品，储罐包括允许经皮装置布置成与储罐的内部流体连通的出口；和排出装置，用来在使用的情形下从储罐和经经皮装置穿过对象的皮肤排出流体药品。经皮单元和储罐单元还包括在使用情形下允许储罐单元固定到经皮单元上的联接装置。经皮器械单元和储罐单元可以包括壳体，在该壳体内分别布置经皮器械的储罐和排出组件。Corresponding to another aspect, there is provided a medical device comprising a transdermal unit and a reservoir unit, wherein the transcutaneous unit comprises a transdermal device for delivering a fluid through a portion of a subject's skin, and a mount adapted to be applied to the subject's skin surface. The storage tank unit comprises: a storage tank adapted to contain a fluid drug, the storage tank including an outlet allowing the transdermal device to be placed in fluid communication with the interior of the storage tank; The transdermal device expels the fluid drug through the subject's skin. The transcutaneous unit and the reservoir unit also comprise coupling means allowing the reservoir unit to be secured to the transcutaneous unit in a situation of use. The percutaneous device unit and the reservoir unit may comprise a housing, within which the reservoir and the drain assembly of the percutaneous device are respectively arranged.

术语“经皮”覆盖其中通过一部分皮肤运送流体的所有形式的给药，例如皮内或皮下给药。经皮装置可以为经皮器械、喷射注入装置或通过使用离子电渗透疗法的原理使离子药剂从皮肤表面上的预定地点渗入对象的皮下组织的电极的形式。对于离子电渗透疗法的更透彻讨论，参考作为参考引入的美国专利6,622,037。依据经皮装置的性质，排出装置可以具有不同的构造和性质。例如，当使用一个或多个空心输液针或插管时，排出装置可以布置成加压或抽吸来自储罐的流体药品，而在离子电渗透疗法的情况下，排出装置是用来在一组电极上施加电流的装置，即“驱动”装置。The term "transdermal" covers all forms of administration in which a fluid is delivered through a part of the skin, eg intradermal or subcutaneous administration. A transdermal device may be in the form of a transdermal device, a jet injection device, or an electrode that infiltrates an ionic agent from a predetermined location on the skin surface into the subcutaneous tissue of a subject by using the principles of iontophoresis. For a more thorough discussion of iontophoresis, refer to US Patent 6,622,037, which is incorporated by reference. Depending on the nature of the transcutaneous device, the ejection device can have different configurations and properties. For example, when one or more hollow infusion needles or cannulas are used, the expulsion device may be arranged to pressurize or draw fluid drug from the reservoir, while in the case of iontophoresis, the expulsion device is used in a A device that applies current to a set of electrodes, the "driver" device.

对应于又一个方面，提供一种包括经皮器械单元和储罐单元的医疗器械，其中经皮器械单元包括：经皮器械，包括适于透过对象的皮肤的尖端；和安装表面，适于施加到对象的皮肤上。储罐单元包括：储罐，适于容纳流体药品；和排出组件，适于与储罐合作以从储罐和经经皮器械穿过对象的皮肤排出流体药品。经皮器械单元和储罐单元还适于在使用情形下彼此固定，由此允许在储罐与经皮器械之间建立流体连通。经皮器械单元和储罐单元可以包括在使用情形下允许储罐单元固定到经皮器械单元上的可释放联接装置。包括两个单元的这样一种医疗器械也可以认为是一种医疗系统。Corresponding to yet another aspect, there is provided a medical device comprising a percutaneous device unit and a storage tank unit, wherein the percutaneous device unit comprises: a percutaneous device comprising a tip adapted to penetrate the skin of a subject; and a mounting surface adapted to Applied to the subject's skin. The reservoir unit includes: a reservoir adapted to contain a fluid drug; and a drain assembly adapted to cooperate with the reservoir to drain the fluid drug from the reservoir and the transcutaneous device through the skin of the subject. The percutaneous device unit and the reservoir unit are also adapted to be secured to each other in the situation of use, thereby allowing fluid communication to be established between the reservoir and the percutaneous device. The percutaneous device unit and the reservoir unit may comprise releasable coupling means allowing the reservoir unit to be secured to the percutaneous device unit in a situation of use. Such a medical device comprising two units may also be considered a medical system.

术语排出组件覆盖组合提供可从储罐排出流体的元件或结构的集合。排出组件例如可以是与电子控制致动装置相结合的机械泵(例如，隔膜泵、活塞泵或滚子泵)、机械驱动泵(例如，由弹簧驱动)、气体驱动泵或由渗透引擎驱动的泵。The term drain assembly covers a combination providing a collection of elements or structures that can drain fluid from a tank. The discharge assembly can be, for example, a mechanical pump (e.g., a diaphragm, piston, or roller pump), a mechanically driven pump (e.g., driven by a spring), a gas-driven pump, or an osmotic engine driven pump combined with an electronically controlled actuation device. Pump.

安装表面适于贴着对象(例如，用户或病人)的皮肤施加，并且可以由在安装表面外部的附连装置(例如，允许医疗器械联接到皮肤可安装器械上的联接装置、或者粘合绷带或敷料)或由提供在安装表面上的粘合装置保持与皮肤接触。安装表面也可以适于经皮肤可安装器械的间置元件向皮肤安装，例如，皮肤可安装器械可以包括医疗器械附加到其上的接收部分，经皮器械穿过在接收部分中的开口插入到皮肤中。The mounting surface is suitable for application against the skin of the subject (e.g., a user or patient) and may be provided by an attachment device external to the mounting surface (e.g., an attachment device that allows a medical device to be attached to a skin-mountable device, or an adhesive bandage). or dressing) or are kept in contact with the skin by adhesive means provided on the mounting surface. The mounting surface may also be suitable for mounting an intervening element of a percutaneously mountable device to the skin, for example, the skin mountable device may comprise a receiving portion to which the medical device is attached, the percutaneous device being inserted through an opening in the receiving portion into in the skin.

通过以上布置，可实现不同的概念。例如，通过提供至少两个不同的单元之一，将有可能提供两种或多种组合，其中经皮器械单元和储罐单元的每种组合提供一种具有不同能力的组件，如下面进一步详细讨论的那样。在单元设有可释放联接装置的情况下，单元之一可与新的或不同的单元互换而允许另一个单元再使用，由此延长再使用单元的操作寿命。因而，本发明在典型实施例中提供一种将给用户提供界面的元件包括在第一单元中而将本身提供药品输送的元件包括在第二单元中的装置，这允许组合元件以简单、可靠及用户友好的方式组合或互换。With the above arrangement, different concepts can be realized. For example, by providing one of at least two different units, it will be possible to provide two or more combinations, wherein each combination of percutaneous device unit and reservoir unit provides an assembly with different capabilities, as detailed further below as discussed. Where the units are provided with releasable coupling means, one of the units may be interchanged with a new or different unit allowing the other unit to be reused, thereby extending the operational life of the reusable unit. Thus, the present invention provides, in an exemplary embodiment, a device in which an element that provides an interface to the user is included in a first unit and an element that itself provides drug delivery is included in a second unit, which allows combining the elements in a simple, reliable manner. and user-friendly way to combine or interchange.

例如，储罐单元可以设有一定药品量和输送泵，该输送泵包括允许药品输送超过例如10天的能量源，而经皮器械单元可以设有经皮器械和在安装表面上的粘合表面，该粘合表面具有2天的期望(推荐)操作寿命，这允许储罐单元在10天的时段上与5个经皮器械单元一起使用，这显著降低了使用组合器械的总成本。储罐可以预填充或适于填充一次或多次。For example, a reservoir unit may be provided with an amount of drug and a delivery pump including an energy source that allows delivery of the drug over, say, 10 days, while a transdermal device unit may be provided with a transdermal device and an adhesive surface on the mounting surface , the adhesive surface has an expected (recommended) operating life of 2 days, which allows the reservoir unit to be used with 5 percutaneous device units over a period of 10 days, which significantly reduces the overall cost of using the combined device. Tanks can be prefilled or adapted to be filled one or more times.

另一方面，经皮器械单元可以设有例如针或软插管、和允许针单元安装和在延长时间段上使用的粘合装置(例如，用来与结肠造口术袋附连的类型)，例如当必须输注比较大量的药品时，储罐单元具有较短的期望操作寿命。可选择地，具有不同类型的药品的不同储罐单元可以与这样一种“长期”安装针单元组合地使用。On the other hand, the percutaneous device unit may be provided with, for example, a needle or soft cannula, and adhesive means (e.g., of the type used to attach to a colostomy bag) that allow the needle unit to be installed and used over an extended period of time. , for example when a relatively large amount of medicine has to be infused, the tank unit has a short expected operating life. Alternatively, different reservoir units with different types of drug could be used in combination with such a "long term" mounted needle unit.

为了容易使用，当针单元和储罐单元彼此固定时可以建立在针与储罐之间的流体连通，就像排出装置当针单元和储罐单元彼此固定时可以被致动并且当单元彼此脱开时不被致动那样。实际上，一种或两种操作也可以由用户手动地进行。For ease of use, a fluid communication between the needle and the reservoir can be established when the needle unit and the reservoir unit are secured to each other, just as the expulsion device can be actuated when the needle unit and the reservoir unit are secured to each other and when the units are detached from each other Not actuated like that when on. In fact, one or both operations can also be performed manually by the user.

在典型实施例中，排出组件包括泵，该泵具有适于布置成与储罐的出口流体连通的进口、和适于布置成与经皮器械流体连通的出口，由此允许经皮装置布置成与储罐的内部流体连通。通过样一种布置，泵用作从储罐抽吸药品的吸入泵，该储罐结果必须是可压扁的或者在使用不可压扁储罐的情况下要通气。排出组件也可以为适于给储罐加压的装置的形式，例如用来在包括可移动活塞的储罐中驱动活塞的装置。储罐单元可以包括多于一个储罐和多于一个排出组件。例如，单个排出组件可以用来从多于一个储罐排出药品，由此同时混合药品或交替药品，或者每个储罐可以设有排出组件，该排出组件可以连接到公共经皮器械上或者连接到个别经皮器械上，例如经皮器械单元可以包括适于连接到排出组件上的多于一个的经皮器械。In an exemplary embodiment, the exhaust assembly includes a pump having an inlet adapted to be arranged in fluid communication with an outlet of the reservoir, and an outlet adapted to be arranged in fluid communication with the transcutaneous device, thereby allowing the transcutaneous device to be placed in In fluid communication with the interior of the storage tank. With such an arrangement, the pump acts as a suction pump for drawing medicine from the tank, which must then be crushable or vented in the case of non-collapsible tanks. The discharge assembly may also be in the form of a device suitable for pressurizing the tank, such as a device for driving a piston in a tank comprising a movable piston. A storage tank unit may include more than one storage tank and more than one discharge assembly. For example, a single ejection assembly could be used to eject drug from more than one storage tank, thereby simultaneously mixing or alternating drugs, or each reservoir could be provided with an ejection assembly that could be connected to a common transcutaneous device or to a To an individual percutaneous device, for example a percutaneous device unit may comprise more than one percutaneous device adapted to be connected to the ejection assembly.

为了提供通过泵的初始无菌流动通道，流动通道可以布置在进口与出口之间，从而进口和出口密封所述泵的内部，并由此流动通道处于初始无菌状态下。通过种布置，将不必提供作为完全无菌单元的储罐单元，实际上药品必须在无菌状态下提供。To provide an initially sterile flow channel through the pump, the flow channel may be arranged between the inlet and outlet such that the inlet and outlet seal the interior of the pump and thus the flow channel is initially sterile. With this arrangement, it will not be necessary to provide the tank unit as a completely sterile unit, in fact the medicine must be provided in a sterile state.

在示例实施例中，储罐单元可从其中泵与储罐之间没有流体连通的初始状态变换到其中当泵单元第一次固定到针单元上时在泵的进口装置与储罐的出口装置之间建立流体连通的不可逆操作状态。通过种布置，避免有害物质在泵与储罐的重新连接期间被引入到储罐中。In an example embodiment, the reservoir unit can be transformed from an initial state in which there is no fluid communication between the pump and the reservoir to a state in which there is a gap between the inlet arrangement of the pump and the outlet arrangement of the reservoir when the pump unit is first secured to the needle unit. An irreversible operating state in which fluid communication is established between them. By this arrangement, it is avoided that harmful substances are introduced into the tank during reconnection of the pump to the tank.

为了保证在泵与储罐之间的清洁连接，在初始条件下，分离流体连接器可以布置在泵的内部内。这样一种流体连接器可以包括尖的进口端和出口，而泵的进口和储罐的出口可以处于两个针可透过膜的形式。通过种布置，流体连接器的尖端，例如连接针，可穿过所述两个膜运动，并因而在初始条件与其中在储罐的内部与泵的内部之间经流体连接器建立流体连通的操作条件之间运动，流体连接器的出口布置在流动通道中。优选地当储罐单元第一次连接到经皮装置单元上时，流体连接器在其两个位置之间运动。对应地，在这样一种第一次连接期间，将建立两种流体连通(在经皮器械的经皮器械与泵之间、和在泵与储罐之间)，而在以后连接期间，只建立单个新的流体连通(在经皮器械单元的经皮器械与泵之间)。In order to ensure a clean connection between the pump and the tank, in initial conditions a separate fluid connector can be arranged inside the interior of the pump. Such a fluid connector may comprise a pointed inlet port and outlet, while the inlet of the pump and the outlet of the tank may be in the form of two needle permeable membranes. With this arrangement, the tip of the fluid connector, such as a connection needle, can move through the two membranes and thus in an initial condition and a fluid connection between the interior of the tank and the interior of the pump is established via the fluid connector. To move between operating conditions, the outlet of the fluid connector is arranged in the flow channel. Preferably the fluid connector is moved between its two positions when the reservoir unit is first connected to the transcutaneous device unit. Correspondingly, during such a first connection, two fluid communications will be established (between the percutaneous device of the percutaneous device and the pump, and between the pump and the reservoir), while during subsequent connections only A single new fluid communication (between the percutaneous device of the percutaneous device unit and the pump) is established.

在示例实施例中，经皮器械包括具有尖的远端的第一部分、和与第一部分流体连通并且具有第二端的第二部分。优选地经皮器械的第二端是尖的，并且泵的出口装置包括允许优选地当两个单元彼此连接时在经皮器械的第二端与泵的内部之间建立流体连通的针可透过膜。In an example embodiment, a percutaneous device includes a first portion having a pointed distal end, and a second portion in fluid communication with the first portion and having a second end. Preferably the second end of the percutaneous device is pointed and the outlet means of the pump comprises a needle permeable needle allowing fluid communication to be established between the second end of the percutaneous device and the interior of the pump, preferably when the two units are connected to each other. Over film.

对应地，在另一个方面，本发明提供一种泵，该泵具有适于布置成与流体供给源流体连通的进口装置、和出口装置，该泵包括在进口与出口装置之间布置的内部流动通道，进口与出口装置密封所述泵的内部并由此把流动通道密封在初始无菌条件下，其中在初始条件下流体连接装置布置在泵的内部，流体连接装置包括进口端和出口，借此流体连接装置布置成在初始条件与其中进口端从泵进口装置伸出的操作条件之间运动，借此在流体供给源与泵的内部之间经流体连接装置和借助于布置在流动通道中的流体连接装置的出口可建立流体连通。Correspondingly, in another aspect, the invention provides a pump having inlet means adapted to be arranged in fluid communication with a fluid supply, and outlet means, the pump comprising an internal flow Channel, inlet and outlet means seal the interior of the pump and thereby seal the flow channel under initial sterile conditions, wherein in the initial condition a fluid connection is arranged inside the pump, the fluid connection includes an inlet and an outlet, by The fluid connection means is arranged to move between an initial condition and an operating condition in which the inlet port protrudes from the pump inlet means, whereby between the fluid supply source and the interior of the pump via the fluid connection means and by means of the fluid connection means arranged in the flow channel The outlet of the fluid connection device can establish fluid communication.

经皮器械单元可以装有例如从安装表面伸出的针，然而，为了限制意外针伤害的危险，经皮装置的尖端优选地可在其中尖端相对于安装表面缩回的初始位置与其中尖端相对于安装表面伸出的延伸位置之间运动。依据把器械安装在用户上的打算方法，当两个单元彼此连接时经皮器械可以在两个位置之间运动，如在连接储罐单元之前经皮器械单元安装在用户的皮肤上的情况下将是正确的。然而，在组装单元安装在用户的皮肤上之前两个单元打算彼此连接的情况下，经皮器械单元优选地包括用来在初始与延伸位置之间移动经皮装置的尖端的用户可致动的致动装置。The percutaneous device unit may be provided with, for example, a needle protruding from the mounting surface, however, in order to limit the risk of accidental needle injury, the tip of the percutaneous device is preferably opposite to where the tip is in an initial position in which the tip is retracted relative to the mounting surface Moves between extended positions where the mounting surface protrudes. Depending on the intended method of mounting the device on the user, the percutaneous device can be moved between two positions when the two units are connected to each other, as in the case where the percutaneous device unit is mounted on the user's skin before the reservoir unit is connected will be correct. However, where the two units are intended to be connected to each other before the assembled unit is mounted on the user's skin, the percutaneous device unit preferably includes a user-actuatable tip for moving the tip of the percutaneous device between initial and extended positions. Actuating device.

为了防止在两个单元组装之前经皮器械的意外致动，经皮器械单元可以包括用来阻挡致动装置的装置，当经皮器械单元和储罐单元彼此固定时，释放该阻挡装置，由此允许致动装置致动。In order to prevent accidental actuation of the percutaneous device before the assembly of the two units, the percutaneous device unit may comprise means for blocking the actuation means, which is released when the percutaneous device unit and the reservoir unit are secured to each other, by This allows the actuation device to actuate.

为了进一步减小经皮器械伤害的可能性，经皮器械的尖端在其中尖端相对于安装表面伸出的延伸位置与其中尖端相对于安装表面缩回的缩回位置之间可以是可运动的。对应地，组合器械可以包括当缩回装置被致动时用来在延伸与缩回位置之间移动经皮器械的尖端的用户可致动缩回装置。为了防止经皮器械的重新使用，经皮装置可以永久地被锁定在其缩回位置中。To further reduce the potential for injury of the percutaneous device, the tip of the percutaneous device may be movable between an extended position in which the tip is extended relative to the mounting surface and a retracted position in which the tip is retracted relative to the mounting surface. Correspondingly, the combination device may include user-actuatable retraction means for moving the tip of the percutaneous device between the extended and retracted positions when the retraction means is actuated. To prevent re-use of the percutaneous device, the percutaneous device may be permanently locked in its retracted position.

为了防止用户错误，用来引入经皮器械的致动装置可以在初始条件下覆盖缩回装置，致动装置的致动暴露该缩回装置。例如，致动装置可以是被从器械除去的握持装置(例如，带条)的形式，借此所述除去操作触发经皮器械的插入，并且同时暴露用来退回经皮器械的缩回装置。In order to prevent user errors, the actuation means used to introduce the percutaneous instrument may cover the retraction means in an initial condition, the actuation of the actuation means revealing the retraction means. For example, the actuation means may be in the form of a gripping means (e.g., a strap) that is removed from the instrument, whereby said removal triggers insertion of the percutaneous instrument and simultaneously exposes retraction means for retracting the percutaneous instrument. .

如上所述，当组装和拆开两个单元时，可以致动和不致动排出组件，然而，致动装置和缩回装置也可以用来分别致动和不致动排出组件。就像对于在泵与储罐之间的初始连接那样，排出组件的初始致动可以导致由于泵送动作的开始而启动电子控制装置，而以后不致动将仅不致动实际的泵送动作，控制装置仍然是活动的(例如，从控制装置的初始致动起计数时间)。As mentioned above, the ejection assembly can be actuated and deactivated when assembling and disassembling the two units, however, the actuation means and the retraction means can also be used to actuate and deactivate the ejection assembly respectively. As with the initial connection between the pump and the tank, an initial actuation of the discharge assembly may result in activation of the electronic control due to the start of the pumping action, whereas subsequent inactivation will simply not actuate the actual pumping action, the control The device is still active (eg counting time from initial actuation of the control device).

在本发明的以上公开中，两个单元已经主要描述为“整体”单元，然而，这只是示例构造，并且这两个“主要”单元可以在认为希望的情况下细分成另外的单元。例如，储罐单元可以设有可互换控制单元，这允许不同类型的控制单元连接到储罐单元本身上，例如第一类型的控制单元可以提供单种输送分布，第二控制单元可以是可编程的以由此修改输送方案，或者控制第三单元可以包括允许控制单元与外部装置通信的装置。在后一种情况下，控制单元可以使用无绳远程控制而控制。对应地，储罐可以是可互换的，允许使用不同尺寸的储罐或不同类型的药品。In the above disclosure of the present invention, two units have been mainly described as "integral" units, however, this is only an example configuration, and these two "main" units may be subdivided into further units if deemed desirable. For example, the tank unit may be provided with interchangeable control units, which allow different types of control units to be connected to the tank unit itself, for example a first type of control unit may provide a single delivery profile and a second control unit may be Programming to thereby modify the delivery regimen, or controlling the third unit may include means allowing the control unit to communicate with external devices. In the latter case, the control unit can be controlled using a cordless remote control. Correspondingly, the tanks may be interchangeable, allowing the use of different sized tanks or different types of medicines.

在本发明的另一个方面，经皮器械单元按以上描述提供，并且如以上公开的那样适于与储罐单元组合地使用。对应地，本发明如以上公开的那样也提供一种储罐单元，该储罐单元如以上公开的那样适于与经皮器械单元组合地使用。在典型实施例中，这样一种经皮器械单元可以设有空心针，该空心针包括具有出口开口并且适于透入对象的皮肤的尖的远端、和具有形成流体进口装置的进口开口的尖的近端，流体进口装置适于布置成与流体供给源流体连通。通过这种布置，针提供了针进口与出口开口之间的液压刚性流体连通(例如，由金属形成)，这样通过监视针上游的压力累积而实现了对早期闭塞的检测。In another aspect of the invention, a percutaneous device unit is provided as described above and adapted for use in combination with a reservoir unit as disclosed above. Correspondingly, the present invention also provides a storage tank unit as disclosed above, which is suitable for use in combination with a percutaneous device unit as disclosed above. In a typical embodiment, such a percutaneous device unit may be provided with a hollow needle comprising a pointed distal end having an outlet opening and adapted to penetrate the skin of a subject, and an inlet opening forming a fluid inlet means. With a pointed proximal end, the fluid inlet device is adapted to be placed in fluid communication with a fluid supply. With this arrangement, the needle provides hydraulically rigid fluid communication (eg, formed of metal) between the needle inlet and outlet openings, such that detection of early occlusion is achieved by monitoring pressure buildup upstream of the needle.

在又一个方面，提供一种系统，该系统包括第一针单元、和如以上公开的那样与至少一个另外针单元连通的第一储罐单元或以上公开的储罐单元，另外的单元具有与第一单元不同的能力。不同的能力可以涉及单元的任何构造特征，例如针的类型、用户可致动装置的类型、输送/泵送装置的类型、或储罐/药品的类型。In yet another aspect, there is provided a system comprising a first needle unit, and a first reservoir unit as disclosed above, or a reservoir unit as disclosed above, in communication with at least one additional needle unit, the additional unit having a Different abilities of the first unit. The different capabilities may relate to any constructional feature of the unit, such as the type of needle, type of user-actuatable device, type of delivery/pumping device, or type of reservoir/drug.

更明确地说，在典型实施例中，提供一种包括以上公开的经皮器械单元和多个储罐单元的系统，每个储罐单元包括容纳流体药品的储罐和用来把流体药品从储罐排出的排出组件。经皮器械单元和储罐单元包括允许储罐单元固定到经皮器械单元上以提供储罐与经皮器械之间的流体连通的配对联接装置，其中经皮器械单元和储罐单元的每种组合提供具有不同能力的组件。可以实现提供例如具有相同药品的不同量的储罐单元、具有不同药品或给定药品的变形的储罐单元、适于以不同预置速率排出的储罐单元、适于以固定分别可选择速率排出的储罐单元的不同能力。储罐单元的一种可以设有控制排出组件的处理器、和可操作地联接到控制器上用来从分离控制器械接收流动指令和把流动指令输送到处理器的接收器。接收器可以是无线接收器。储罐单元可以还设有不同的输入装置(例如，用于无线或有线连接、或手动输入)或不同的输出装置(例如，用于无线或有线连接、不同的显示装置或不同的报警装置)。More specifically, in an exemplary embodiment, there is provided a system comprising the above-disclosed transcutaneous device unit and a plurality of tank units, each tank unit comprising a tank containing a fluid drug and for transferring the fluid drug from Discharge assembly for tank discharge. The percutaneous device unit and the reservoir unit include mating coupling means that allow the reservoir unit to be secured to the percutaneous device unit to provide fluid communication between the reservoir and the percutaneous device, wherein each of the percutaneous device unit and the reservoir unit Composition provides components with different capabilities. It is possible to provide, for example, tank units with different quantities of the same drug, tank units with different drugs or variants of a given drug, tank units adapted to discharge at different preset rates, adapted to discharge at fixed respectively selectable rates Different capacities of discharged tank units. One type of storage tank unit may be provided with a processor controlling the discharge assembly, and a receiver operably coupled to the controller for receiving flow commands from the separation control device and delivering the flow commands to the processor. The receiver may be a wireless receiver. The tank unit may also be provided with different input devices (for example, for wireless or wired connection, or manual input) or different output devices (for example, for wireless or wired connection, different display devices or different alarm devices) .

在另一个典型实施例中，提供一种包括以上公开的多个经皮器械单元和储罐单元的系统，储罐单元包括容纳流体药品的储罐、和用来把流体药品从储罐排出的排出组件。经皮器械单元和储罐单元包括允许经皮器械单元固定到储罐单元上以提供储罐与经皮器械之间的流体连通的配对联接装置，其中经皮器械单元和储罐单元的每种组合提供具有不同能力的组件。通过提供具有诸如空心皮下针、插管和输液针组件、及显微针阵列之类的不同经皮器械的经皮器械单元，通过提供不同的粘合剂，通过提供不同的插入或缩回装置，或通过提供不同的联接装置，可以实现不同的能力。In another exemplary embodiment, there is provided a system comprising a plurality of percutaneous device units disclosed above and a storage tank unit, the storage tank unit comprising a storage tank containing a fluid drug, and a device for discharging the fluid drug from the storage tank. Drain the components. The percutaneous device unit and the reservoir unit include mating coupling means that allow the percutaneous device unit to be secured to the reservoir unit to provide fluid communication between the reservoir and the percutaneous device, wherein each of the percutaneous device unit and the reservoir unit Composition provides components with different capabilities. By providing percutaneous device units with different percutaneous devices such as hollow hypodermic needles, cannula and infusion needle assemblies, and microneedle arrays, by providing different adhesives, by providing different insertion or retraction mechanisms , or by providing different coupling devices, different capabilities can be achieved.

本发明也提供一种方法，该方法包括步骤：提供包括经皮器械和安装表面的经皮器械单元；提供储罐单元，该储罐单元包括适于容纳流体药品的储罐、和用来从储罐排出流体药品的排出组件，该方法包括组装经皮器械单元和储罐单元以提供储罐与经皮器械之间的流体连通的另外步骤。当组装两个单元时可以建立在经皮器械与储罐之间的流体连通，或者当进一步致动组装器械时可以建立这种流体连通，两种选择都由以上限定覆盖。该方法可以包括另外的步骤：把安装表面安装到对象的皮肤表面上；和在把安装表面安装到对象的皮肤表面上之后，致动经皮器械以在储罐与对象之间建立流体连通。The present invention also provides a method comprising the steps of: providing a transcutaneous device unit comprising a transcutaneous device and a mounting surface; providing a storage tank unit comprising a storage tank adapted to contain a fluid drug, and a A cartridge venting fluid drug discharge assembly, the method comprising the further step of assembling a transcutaneous device unit and a cartridge unit to provide fluid communication between the cartridge and the transcutaneous device. The fluid communication between the percutaneous device and the reservoir may be established when assembling the two units, or may be established when further actuating the assembled device, both options covered by the above definition. The method may include the additional steps of: mounting the mounting surface on the subject's skin surface; and actuating the transcutaneous device to establish fluid communication between the reservoir and the subject after mounting the mounting surface on the subject's skin surface.

另一种方法提供以预设速率分配药品的药品输送器械，该方法包括步骤：提供一种系统，该系统包括经皮器械单元，该经皮器械单元包括经皮器械和适于施加到对象的皮肤上的安装表面，系统还包括多个储罐单元，每个储罐单元包括容纳流体药品的储罐、和用来以预设速率从储罐排出流体的排出组件；选择具有希望预设速率的储罐单元；及组装经皮器械单元和选择的储罐单元，以提供储罐与经皮器械之间的流体连通。Another method of providing a drug delivery device that dispenses a drug at a predetermined rate includes the steps of: providing a system that includes a transdermal device unit including a transdermal device and a device adapted to be applied to a subject. The mounting surface on the skin, the system also includes a plurality of tank units, each tank unit including a tank containing the fluid drug, and a discharge assembly for discharging the fluid from the tank at a preset rate; and assembling the transcutaneous device unit and the optional reservoir unit to provide fluid communication between the reservoir and the percutaneous device.

如这里使用的那样，术语“药品”是指包容能够以受控方式穿过诸如空心针之类的输送装置的任何含药品可流动药物，如液体、溶液、凝胶或细悬浮物。代表性药品包括：药剂，如肽、蛋白、及激素；生物衍生或活性试剂；激素和基因基试剂；营养配方；及固体(分散)或液体形式的其它物质。在典型实施例的描述中，将提到胰岛素的使用。对应地，术语“皮下”注射是指包容对于对象经皮输送的任何方法。而且，术语针(当没有另外规定时)限定适于透入对象皮肤的穿刺部件。As used herein, the term "medicament" refers to any drug-containing flowable drug, such as a liquid, solution, gel, or fine suspension, containing a drug-containing flowable drug that can pass through a delivery device such as a hollow needle in a controlled manner. Representative pharmaceuticals include: pharmaceutical agents, such as peptides, proteins, and hormones; biologically derived or active agents; hormones and gene-based agents; nutritional formulas; and other substances in solid (dispersion) or liquid form. In the description of exemplary embodiments, reference will be made to the use of insulin. Correspondingly, the term "subcutaneous" injection is meant to encompass any method of percutaneous delivery to a subject. Also, the term needle (when not specified otherwise) defines a piercing member adapted to penetrate the skin of a subject.

附图说明Description of drawings

在下面，将参照附图进一步描述本发明，在附图中：In the following, the invention will be further described with reference to the accompanying drawings, in which:

图1-11以立体图表示对于药品输送器械的第一实施例的使用顺序，Figures 1-11 show in perspective views the sequence of use for the first embodiment of the drug delivery device,

图12表示储罐单元的另一个实施例，Figure 12 shows another embodiment of the tank unit,

图13以非组装状态表示用于药品输送器械的另一个实施例的针单元和储罐单元，Figure 13 shows a needle unit and a reservoir unit for another embodiment of a drug delivery device in a non-assembled state,

图14表示图13的针单元的分解视图，Figure 14 shows an exploded view of the needle unit of Figure 13,

图15表示图13的针单元在第一状态下的立体图，Figure 15 shows a perspective view of the needle unit of Figure 13 in a first state,

图16表示图14的针载体的立体图，Figure 16 shows a perspective view of the needle carrier of Figure 14,

图17表示图13的针单元在第二状态下的立体图，Figure 17 shows a perspective view of the needle unit of Figure 13 in a second state,

图18表示图13的针单元的侧视图，Figure 18 shows a side view of the needle unit of Figure 13,

图19表示图13的储罐单元的另外立体图，Figure 19 shows another perspective view of the storage tank unit of Figure 13,

图20表示图13的储罐单元的内部的立体图，Figure 20 shows a perspective view of the interior of the storage tank unit of Figure 13,

图21表示另一种储罐单元的分解视图，Figure 21 shows an exploded view of another tank unit,

图22A表示连接到储罐上的泵的示意概要，Figure 22A shows a schematic outline of a pump connected to a storage tank,

图22B表示泵组件的分解视图，Figure 22B shows an exploded view of the pump assembly,

图22C表示图22C的泵组件的横截面视图，Figure 22C represents a cross-sectional view of the pump assembly of Figure 22C,

图22D和22E表示图22C的泵组件的局部横截面视图，22D and 22E represent partial cross-sectional views of the pump assembly of FIG. 22C,

图23A和23B以示意代表表示插管和插入针组合形式的经皮器械，Figures 23A and 23B schematically represent a combined percutaneous device in the form of a cannula and insertion needle,

图24表示另一种药品输送器械的立体图，Figure 24 shows a perspective view of another drug delivery device,

图25A-25D表示适于与本发明的使用的不同排出装置，Figures 25A-25D show different discharge devices suitable for use with the present invention,

图26表示具有模块储罐单元的医疗器械，及Figure 26 represents a medical device with a modular tank unit, and

图27表示用于医疗器械的模块系统。Figure 27 shows a modular system for a medical device.

在附图中，类似结构主要由类似附图标记辨别。In the drawings, similar structures are primarily identified by similar reference numerals.

具体实施方式Detailed ways

当在下面使用诸如“上部”和“下部”、“右”和“左”、“水平”和“垂直”或类似相对表达之类的术语时，这些仅指附图，而不指实际使用情形。表示的附图是示意代表，为此原因，不同结构的构造以及那里的相对尺寸仅用于说明目的。When terms such as "upper" and "lower", "right" and "left", "horizontal" and "vertical" or similar relative expressions are used below, these refer only to the drawings and not to actual usage . The shown figures are schematic representations, for which reason the configuration of the different structures and the relative dimensions there are used for illustration purposes only.

首先，参照图1-12，将描述一种药品输送器械的实施例，主要集中于直接用户取向特征。经皮器械单元2包括空心输液针形式的经皮器械，并且因而在下面将称作针单元，然而，该针可以用适于流体药品输送的任何希望经皮器械代替。First, with reference to Figures 1-12, an embodiment of a drug delivery device will be described, focusing primarily on the direct user orientation feature. Thetranscutaneous device unit 2 comprises a percutaneous device in the form of a hollow infusion needle and will thus be referred to below as a needle unit, however, the needle may be replaced by any desired percutaneous device suitable for fluid drug delivery.

更明确地说，图1表示一种模块皮肤可安装药品输送器械1的形式的医疗器械的立体图，该药品输送器械1包括盖板状的针单元2和储罐单元5。当供给给用户时，单元的每一个优选地封闭在其自己的密封包装(未表示)内。More specifically, FIG. 1 shows a perspective view of a medical device in the form of a modular skin-mountable drug delivery device 1 comprising a cover-shapedneedle unit 2 and areservoir unit 5 . Each of the units is preferably enclosed within its own sealed package (not shown) when supplied to the user.

针单元包括：基座部分10，具有适于施加到用户皮肤上的下部安装表面；和外壳部分20，其中布置空心输液针(未表示)。所述针包括第一针部分，该第一针部分具有适于透入用户皮肤的尖的远端、和适于布置成与储罐单元流体连通的第二尖端。在图示的实施例中，针的尖端可在其中该尖端相对于安装表面缩回的初始位置与其中尖端相对于安装表面伸出的延伸位置之间运动。而且，针可在其中尖端相对于安装表面伸出的延伸位置与其中尖端相对于安装表面缩回的缩回位置之间运动。针单元还包括：为第一带条部件21形式的用户可握持致动装置，以便当该致动装置被致动时在初始位置与第二位置之间移动针的尖端；为第二带条部件22形式的用户可握持缩回装置，以便当该缩回装置被致动时在延伸位置与缩回位置之间移动针的尖端。如可看到的那样，第二带条初始由第一带条覆盖。所述外壳还包括适于与在储罐单元上的对应下凹联接装置合作的一对弹性布置钩形部件形式的用户可致动凸出联接装置40，这允许储罐单元在使用的情形下可释放地固定到针单元上。在图示的实施例中，基座部分包括附加到较柔软的粘合片部件12上的比较刚性的上部部分11，该粘合片部件12具有提供安装表面本身的下部粘合表面，粘合表面装有可剥离保护片。基座部分也包括适于与储罐单元上的对应凹槽相接合的隆起部件13。The needle unit comprises: abase part 10 having a lower mounting surface adapted to be applied to the skin of a user; and ahousing part 20 in which a hollow infusion needle (not shown) is arranged. The needle includes a first needle portion having a pointed distal end adapted to penetrate the skin of a user, and a second pointed end adapted to be placed in fluid communication with the reservoir unit. In the illustrated embodiment, the tip of the needle is movable between an initial position in which the tip is retracted relative to the mounting surface and an extended position in which the tip is extended relative to the mounting surface. Furthermore, the needle is movable between an extended position in which the tip is extended relative to the mounting surface and a retracted position in which the tip is retracted relative to the mounting surface. The needle unit further comprises: a user grippable actuating means in the form of afirst strap part 21 for moving the tip of the needle between an initial position and a second position when the actuating means is actuated; A user in the form of abar member 22 can grip the retraction means to move the tip of the needle between an extended position and a retracted position when the retraction means is actuated. As can be seen, the second strip is initially covered by the first strip. The housing also includes user actuatable male coupling means 40 in the form of a pair of resiliently arranged male couplings adapted to cooperate with corresponding female coupling means on the tank unit, which allows the tank unit to Releasably secured to the needle unit. In the illustrated embodiment, the base portion includes a relatively rigidupper portion 11 attached to a relatively softadhesive sheet member 12 having a lower adhesive surface that provides the mounting surface itself, the adhesive The surface is equipped with a peel-off protective sheet. The base portion also includes raisedmembers 13 adapted to engage corresponding recesses on the tank unit.

储罐单元5包括：预填充储罐，容纳流体药品配方(例如胰岛素)；和电子控制泵形式的排出装置，用来在使用情形下从储罐通过针排出药品。储罐单元具有适于安装到基座部分的上部表面上的大体平坦的下部表面，并且包括适于接收在外壳部分20的对应空腔中的突出部分50、以及适于与在针单元上的对应钩形部件31接合的下凹联接装置51。突出部分提供在两个单元之间的界面，并且包括泵出口、和当这两个单元被组装时允许泵启动的触点装置(未表示)。所述下部表面也包括允许用户可视地控制储罐的内装物的窗口(看不到)。Thereservoir unit 5 comprises a pre-filled reservoir containing a fluid drug formulation (eg insulin) and an ejection means in the form of an electronically controlled pump for ejecting the drug from the reservoir through a needle in the case of use. The tank unit has a generally planar lower surface adapted to be mounted on the upper surface of the base portion, and includes a protrudingportion 50 adapted to be received in a corresponding cavity in thehousing portion 20, and adapted to be in contact with a needle unit on the needle unit. The corresponding female coupling means 51 engages with thehook part 31 . The protrusion provides the interface between the two units and includes the pump outlet, and a contact arrangement (not shown) that allows the pump to be activated when the two units are assembled. The lower surface also includes windows (not visible) that allow the user to visually control the contents of the tank.

在安装过程中的第一步骤是通过把储罐单元简单地滑动成与针单元相接合而组装所述两个单元(图2)。当钩形部件正确接合储罐单元时，听到“咔搭”声(图3)，向用户发出这两个单元已经适当组装的信号。如果希望，也可以产生可视或可听信号。此后，用户除去可剥离片14以露出粘合表面(图4)，这之后可把器械附加到用户的皮肤表面上，典型地附加到腹部上(图5)。通过如由箭头指示的那样握持和拉开致动带条21，借此针被插入，接着输注自动启动，从而开始药品的输注(图6)。针插入机构可以在预应力状态下供给，并且以后由致动装置释放，或者针的插入可以由用户“激励”。“蜂鸣”信号确认器械正在操作并且药品被输注。储罐单元优选地设有在例如堵塞、泵故障或内装物用完的情况下向用户提供可听报警信号的信号装置和探测装置。The first step in the installation process is to assemble the two units by simply sliding the cartridge unit into engagement with the needle unit (Figure 2). When the hook member properly engages the tank unit, an audible "click" (Fig. 3) signals to the user that the two units have been properly assembled. Visual or audible signals may also be produced, if desired. Thereafter, the user removes thepeelable sheet 14 to expose the adhesive surface (FIG. 4), after which the device can be attached to the user's skin surface, typically the abdomen (FIG. 5). The infusion of the drug is started by gripping and pulling apart theactuation strip 21 as indicated by the arrow, whereby the needle is inserted and the infusion is then automatically initiated (Fig. 6). The needle insertion mechanism may be supplied in a pre-stressed state and later released by the actuation means, or the insertion of the needle may be "activated" by the user. A "beep" signal confirms that the instrument is operating and that the drug is infused. The tank unit is preferably provided with signaling means and detection means providing an audible warning signal to the user in the event of eg a blockage, pump failure or emptying of contents.

在对于针单元的使用，器械已经搁置到位经过推荐时间段(例如48或72小时)之后-或者在储罐变空的情况下或因为其它原因，通过如由箭头指示的那样握持(图7)和拉动(图8)缩回带条22，导致针的缩回，接着是药品注射的自动停止，这之后附加到粘合片上的带条用来从皮肤表面除去器械(图9)，从而从皮肤除去了该器械。After the instrument has been left in place for a recommended period of time (e.g., 48 or 72 hours) for use with the needle unit—either with the tank empty or for other reasons—by holding it as indicated by the arrow (Fig. 7 ) and pulling ( FIG. 8 ) retracts thestrip 22, resulting in retraction of the needle, followed by automatic cessation of drug injection, after which the strip attached to the adhesive sheet is used to remove the instrument from the skin surface ( FIG. 9 ), thereby The device was removed from the skin.

当已经除去器械时，通过如由箭头指示的那样同时压下两个钩形部件31(图10)，使储罐单元5如由箭头指示的那样脱离与针单元2的接合(图11)，而使两个单元脱开，针单元2然后可丢弃。此后，储罐单元可再次与新的针单元一起使用，直到它变空。When the instrument has been removed, thecartridge unit 5 is disengaged from theneedle unit 2 as indicated by the arrow ( FIG. 11 ) by simultaneously depressing the two hook members 31 ( FIG. 10 ) as indicated by the arrow, Instead of disengaging the two units, theneedle unit 2 can then be discarded. Thereafter, the tank unit can be used again with a new needle unit until it is empty.

储罐单元可以提供固定的基本输注速率，或者它可以作为具有允许输注速率由医师和/或用户/病人设置的调节装置55的可调节单元(图12)而供给。储罐单元也可以设有允许控制装置被编程或被电子设定的装置(未表示)。The tank unit may provide a fixed basal infusion rate, or it may be supplied as an adjustable unit (Fig. 12) with adjustment means 55 allowing the infusion rate to be set by the physician and/or user/patient. The tank unit may also be provided with means (not shown) allowing the control means to be programmed or set electronically.

参照图1-11描述的器械也可以以可选择的方式使用。例如，针单元可以安装到皮肤上，这之后附加储罐。依据针单元的构造，可能或者防止在附加储罐单元之前引入所述针。The apparatus described with reference to Figures 1-11 may also be used in an alternative manner. For example, the needle unit can be mounted to the skin, after which the reservoir is attached. Depending on the configuration of the needle unit, it may or may be prevented that the needle is introduced before the additional tank unit.

图13表示与图1的实施例大体相对应的医疗器械500的另一个实施例，该器械包括贴片状针单元502和可附加到其上的储罐单元505。Figure 13 shows another embodiment of a medical device 500 generally corresponding to that of Figure 1, comprising a patch-like needle unit 502 and a reservoir unit 505 attachable thereto.

图14表示包括上部外壳部分510、针载体520及安装在其上的输液针530的针单元；致动部件540；释放部件550；下部外壳部分560及薄片部件570的分解立体图。致动部件包括用户可握持部分541和针致动部分542，并且释放部件包括用户可握持部分551和针缩回部分552。在如图15中所示的组装状态下，上部和下部外壳部分形成外壳503，在该外壳503中安装着针和针载体，致动和释放部件可操作地连接到针载体上，用户可握持部分布置在该外壳的外侧。与图1的实施例不同，针单元不包括基座板部分，而是包括从外壳延伸的两个隆起部件561，隆起部件和外壳的下部表面安装在柔性薄片部件上，该柔性薄片部件在其下部表面上设有下部粘合层571，允许针单元附加到对象的皮肤部位上。薄片部件还包括布置成与下部突起565对准的开口572该下部突起565绕用于经皮器械的出口孔设置，就像所述薄片设有大量小开孔以改进通过薄片的呼吸性。外壳503设有允许储罐单元附加到针单元505上和从该针单元释放储罐单元的用户可致动联接装置511，储罐单元包括对应匹配的联接装置506以及显示器587。显示器可以指示例如单元的适当功能、在储罐中的药品量或不同的错误状态。14 shows an exploded perspective view of a needle unit comprising anupper housing part 510, aneedle carrier 520 and aninfusion needle 530 mounted thereon; anactuation member 540; arelease member 550; alower housing part 560 and asheet member 570. The actuation member includes auser grippable portion 541 and aneedle actuation portion 542 , and the release member includes auser grippable portion 551 and aneedle retraction portion 552 . In the assembled state as shown in Figure 15, the upper and lower housing parts form ahousing 503 in which the needle and needle carrier are mounted, the actuation and release components are operatively connected to the needle carrier, and the user can hold the needle. The holding portion is arranged on the outside of the housing. Unlike the embodiment of FIG. 1 , the needle unit does not include a base plate portion, but instead includes two raisedmembers 561 extending from the housing, the raised members and the lower surface of the housing being mounted on a flexible sheet member on which A loweradhesive layer 571 is provided on the lower surface, allowing the needle unit to be attached to the subject's skin site. The foil member also comprises anopening 572 arranged in alignment with alower protrusion 565 arranged around the exit aperture for the percutaneous device, just as the foil is provided with a number of small openings to improve breathability through the foil.Housing 503 is provided with a user-actuatable coupling 511 allowing attachment and release of a cartridge unit to and from needle unit 505 , the cartridge unit comprising corresponding mating coupling 506 and display 587 . The display can indicate for example the proper functioning of the unit, the amount of medicine in the tank or different error states.

如看到的那样，释放部件的用户可握持部件551初始由致动部件上的部分覆盖，这减小了用户误使用释放部件而不是致动部件的可能性。而且，致动和释放部件(或其部分)可以用颜色编码，以进一步有助于用户正确地使用器械。例如，致动部件可以是绿的以指示“启动”，而释放部件可以是红的以指示“停止”。As seen, the user-gripable part 551 of the release part is initially covered by a portion on the actuation part, which reduces the possibility of a user mistakenly using the release part instead of the actuation part. Also, the actuation and release components (or parts thereof) may be color coded to further assist the user in proper use of the instrument. For example, the actuation member may be green to indicate "activation" and the release member may be red to indicate "stop".

图16以立体图表示具有针530的针载体520和致动部件540的针致动部分542。针致动部分包括允许它相对于外壳滑动的两个支腿543，支腿穿过在外壳中的相应开口563布置。针载体适于连接到下部外壳部分的铰链部件562上，由此允许针载体和由此使针与由铰链限定的枢转轴线对应地枢转。在图示的实施例中，针载体为弯曲薄片金属部件的形式，所述载体包括通过铰链部分523彼此连接的上部臂521和下部臂522，允许下部臂相对于上部臂和与枢转轴线相对应地枢转。下部臂形成其中安装空心输液针530的托盘(例如，通过焊接或粘合)，所述针具有：适于透过对象的皮肤的远尖部分531，该远部分大体与针单元的安装表面相垂直地延伸；和近部分532，布置成大体与所述枢转轴线相对应，并且适于接合流体供给源。因而，当上部臂的一部分安装在外壳中时，下部臂可在其中针的远部分缩回在外壳内的第一缩回位置与其中远部分相对于安装表面伸出的第二延伸位置之间枢转。在图示的实施例中，针载体提供用来在两个位置之间移动下部臂的驱动装置。这在本实施例中可以由与铰链部分相对应的薄片材料本身的弹性性质提供，或者可选择地，辅助弹簧可以提供在这两个臂之间以由此把它们推开。为了把下部部分锁定在被激励的可释放第一位置中，上部臂设有：柔性释放臂526，包括把下部臂支撑和捕获在其第一向下偏置位置中的掣子(catch)527；以及释放部分528，与针致动部分542的斜表面544接合，所述掣子还包括当下部臂从其延伸位置向其缩回位置移动时适于接合下部臂的倾斜边缘部分529，如下面将更详细地描述的那样。FIG. 16 shows theneedle carrier 520 with theneedle 530 and theneedle actuation part 542 of theactuation member 540 in a perspective view. The needle actuation part comprises twolegs 543 which allow it to slide relative to the housing, the legs being arranged throughcorresponding openings 563 in the housing. The needle carrier is adapted to be connected to thehinge part 562 of the lower housing part, thereby allowing the needle carrier and thus the needle to pivot correspondingly to the pivot axis defined by the hinge. In the illustrated embodiment, the needle carrier is in the form of a curved sheet metal part, said carrier comprising anupper arm 521 and alower arm 522 connected to each other by ahinge portion 523 allowing the lower arm to pivot relative to the upper arm and to the pivot axis. Pivot accordingly. The lower arm forms a tray into which ahollow infusion needle 530 is mounted (e.g., by welding or gluing), said needle having adistal tip portion 531 adapted to penetrate the subject's skin, which distal portion is substantially in contact with the mounting surface of the needle unit. extending vertically; and aproximal portion 532, arranged generally corresponding to said pivot axis, and adapted to engage a fluid supply. Thus, when a portion of the upper arm is mounted in the housing, the lower arm is movable between a first retracted position in which the distal portion of the needle is retracted within the housing and a second extended position in which the distal portion protrudes relative to the mounting surface pivot. In the illustrated embodiment, the needle carrier provides drive means for moving the lower arm between two positions. This may in this embodiment be provided by the elastic properties of the sheet material itself corresponding to the hinge portion, or alternatively a secondary spring may be provided between the two arms to thereby push them apart. To lock the lower part in the actuated releasable first position, the upper arm is provided with: aflexible release arm 526 including acatch 527 supporting and capturing the lower arm in its first downwardly biased position and arelease portion 528 engaged with the rampedsurface 544 of theneedle actuation portion 542, the catch further comprising a ramped edge portion 529 adapted to engage the lower arm when the lower arm moves from its extended position to its retracted position, as follows as will be described in more detail below.

为了使针致动，用户握住形成用户可握持部分541的柔性带条(它优选包括粘合部分以把它保持在其图示的折叠初始位置中)，并且把针致动部分542拉出外壳，致动部件540由此完全脱离外壳。更明确地说，当倾斜表面544被移动时，它强迫掣子(latch)527离开下部臂以由此释放它，在这之后，释放部分528脱离斜面，允许两个支腿从外壳拉出。如在图17中看到的那样，当除去致动部件时，暴露释放部件的用户可握持部分551。关于致动部件，释放部件的用户可握持部分优选地包括粘合部分，以把它保持在图示的折叠初始位置中。To actuate the needle, the user grasps the flexible strip forming the user-gripable portion 541 (it preferably includes an adhesive portion to keep it in its illustrated folded initial position), and pulls theneedle actuating portion 542 out of the housing whereby the actuatingmember 540 is completely disengaged from the housing. More specifically, when rampedsurface 544 is moved, it forceslatch 527 away from the lower arm thereby releasing it, after which releaseportion 528 disengages the ramp, allowing both legs to be pulled out of the housing. As seen in Figure 17, when the actuation member is removed, theuser grippable portion 551 of the release member is exposed. With regard to the actuation member, the user-gripable portion of the release member preferably includes an adhesive portion to hold it in the illustrated folded initial position.

在图示的实施例中，释放部件为由柔性材料形成并且具有内部和外部端的带条的形式，该带条穿过在外壳中的开口512，带条由此形成用户可握持部分551和针缩回部分552，带条的内部端附连到外壳上，并且带条的外部端附连到薄片部件570的周边部分上，或者可选择地，附连到外壳的周边部分上。在图18中表示的伸出中，释放部件示出在其初始位置中，形成环路555的缩回部分布置在针载体的下部臂的下面，这个位置允许下部臂运动到其致动位置，并由此把针移动到其延伸位置。In the illustrated embodiment, the release member is in the form of a strap formed of flexible material and having inner and outer ends that passes through anopening 512 in the housing, the strap thus forming a user-gripable portion 551 and Theneedle retraction portion 552, the inner end of the strap is attached to the housing, and the outer end of the strap is attached to a peripheral portion of thesheet member 570, or alternatively, to a peripheral portion of the housing. In the extension represented in Figure 18, the release member is shown in its initial position, the retractedportion forming loop 555 is arranged below the lower arm of the needle carrier, this position allows the lower arm to move to its actuated position, and thereby move the needle to its extended position.

当用户决定从皮肤除去针单元时，用户握住用户可握持部分551，把它升离外壳，并且把它向上拉动，借此环路缩短由此向上强迫下部臂，这个位置与中间释放状态相对应。通过这个动作，下部臂接合掣子527的倾斜边缘部分529，由此向外强迫该倾斜边缘部分529，直到它在与图16中表示的位置相对应的下部臂下方卡回。当致动部件540已经从针单元除去时，针载体被不可逆地锁定在其缩回位置中。当用户进一步拉入释放部件时，附连释放部件的薄片部件的周边部分将升离皮肤，借此可从皮肤除去针单元及与其附连的储罐单元，这就像参照图7-9表示和描述的那样。When the user decides to remove the needle unit from the skin, the user grasps the user-gripable portion 551, lifts it off the housing, and pulls it upwards, whereby the loop shortens thereby forcing the lower arm upwards, this position is the same as the intermediate release state Corresponding. With this action, the lower arm engages the beveled edge portion 529 of thedetent 527, thereby forcing the beveled edge portion 529 outward until it snaps back under the lower arm corresponding to the position shown in FIG. When theactuation member 540 has been removed from the needle unit, the needle carrier is irreversibly locked in its retracted position. When the user pulls the release member further in, the peripheral portion of the sheet member to which the release member is attached will lift off the skin, whereby the needle unit and its attached reservoir unit can be removed from the skin, as shown with reference to Figures 7-9. and as described.

优选地，致动和释放部件可以形成为和布置成与储罐单元(未表示)连通。例如，致动部件的支腿之一可以在其初始位置中穿过外壳突出，以由此接合储罐单元上的对应触点，这向储罐单元指示已经附连针单元，而致动部件的除去将指示针已经插入并因而可开始药品输注。对应地，释放部件的致动可用来停止泵。Preferably, the actuation and release member may be formed and arranged to communicate with a tank unit (not shown). For example, one of the legs of the actuating member may protrude through the housing in its initial position to thereby engage a corresponding contact on the tank unit, which indicates to the tank unit that the needle unit has been attached, while the actuating member Removal of the needle will indicate that the needle has been inserted and thus drug infusion can begin. Correspondingly, actuation of the release member may be used to stop the pump.

在图19中，表示连接到储罐单元上的针单元502的侧部。除两个隆起部件561和用户可致动联接装置511之外，针单元还包括连接到储罐单元上和/或与其相接合以提供与储罐单元的功能界面的结构。更明确地说，针单元包括：流体进口，由从针单元伸出的针的尖的近部分532提供，并且适于接合储罐单元的流体出口；致动器515，从针单元伸出，并且适于接合和致动在储罐单元中的流体连接器(见下文)；及第一和第二触点致动器548、558，适于接合在储单元上的对应触点。第一触点致动器由穿过在外壳中的开口伸出的针致动器的支腿543之一的远端提供，并且第二触点致动器由连接到释放部件550的针缩回部分552上的外壳的铰链部分提供。当针单元第一次连接到储罐单元上时，两个触点致动器将从外壳突出并且接合储罐单元上的对应触点，由此指示针单元已经被连接。当针被致动时，第一触点致动器将退回，并由此脱开在储罐单元上的对应触点而开始泵致动。当针缩回时，第二触点致动器将枢转，并且脱离在储罐单元上的对应触点而停止泵致动。In Fig. 19, the side of theneedle unit 502 connected to the tank unit is shown. In addition to the two raisedmembers 561 and the user-actuatable coupling 511, the needle unit also includes structure to connect to and/or engage with the cartridge unit to provide a functional interface with the cartridge unit. More specifically, the needle unit comprises: a fluid inlet provided by a pointedproximal portion 532 of the needle extending from the needle unit and adapted to engage a fluid outlet of the reservoir unit; anactuator 515 extending from the needle unit, and adapted to engage and actuate a fluid connector in the tank unit (see below); and first andsecond contact actuators 548, 558 adapted to engage corresponding contacts on the tank unit. The first contact actuator is provided by the distal end of one of thelegs 543 of the needle actuator extending through an opening in the housing, and the second contact actuator is provided by a needle retractor connected to therelease member 550.Back portion 552 is provided on the hinge portion of the housing. When the needle unit is connected to the tank unit for the first time, the two contact actuators will protrude from the housing and engage corresponding contacts on the tank unit, thereby indicating that the needle unit has been connected. When the needle is actuated, the first contact actuator will retract and thereby disengage the corresponding contact on the tank unit to initiate pump actuation. When the needle is retracted, the second contact actuator will pivot and disengage the corresponding contact on the tank unit, stopping pump actuation.

图20表示在除去外壳的上部部分情况下的储罐单元。储罐单元包括：储罐760；和排出组件，包括泵组件300及其控制和致动装置580、581。泵组件包括用于连接到经皮接近器械(例如，针530)上的出口322和允许内部流体连接器致动的开口323，见下文。储罐560处于预填充的、柔性的和可压扁的袋的形式，该袋包括适于布置成与泵组件流体连通的针可透过膜，见下文。图示的泵组件是机械致动薄膜泵，然而，储罐和排出装置可以具有任何适当的构造，例如像参照图25A-25D公开的那样。Figure 20 shows the tank unit with the upper part of the housing removed. The storage tank unit comprises: a storage tank 760; and a discharge assembly including apump assembly 300 and its control and actuation means 580,581. The pump assembly includes anoutlet 322 for connection to a percutaneous access device (eg, needle 530 ) and anopening 323 to allow actuation of the internal fluid connector, see below. Thereservoir 560 is in the form of a pre-filled, flexible and collapsible bag comprising a needle permeable membrane adapted to be placed in fluid communication with the pump assembly, see below. The illustrated pump assembly is a mechanically actuated membrane pump, however, the reservoir and drain may have any suitable configuration, eg as disclosed with reference to Figures 25A-25D.

控制和致动装置包括：泵致动部件，为线圈致动器581的形式，布置成致动隔膜泵的活塞；PCB或挠性芯头(flex-print)，与用来尤其控制泵致动的微处理器583相连；触点588、589，与针单元上的触点致动器合作；信号发生装置585，用来产生可听和/或可感知的信号；显示器(未表示)；及能量源586。触点优选地由隔膜保护，该隔膜可以由外壳的柔性部分形成。The control and actuation means comprise: pump actuation means, in the form of a coil actuator 581, arranged to actuate the piston of the diaphragm pump; The microprocessor 583 is connected; The contacts 588, 589 cooperate with the contact actuators on the needle unit; The signal generating device 585 is used to generate audible and/or perceivable signals; Display (not shown); and Energy source 586. The contacts are preferably protected by a membrane, which may be formed by a flexible part of the housing.

在图21中，表示图13的储罐单元505的分解视图，该单元包括：上部外壳部件507；下部外壳部件508，具有透明区域509和接收从针单元延伸的隆起部件561的凹槽504；柔性储罐760，具有倒圆的边缘部分762，在该边缘部分762上安装膜部件761；泵组件300，具有布置在储罐上方的致动器和电路板(未表示)，并且包括用来控制泵的致动的电子元件。上部和下部外壳部件包括为相对的上部和下部隆起部分780形式的适于接合和安装位于外壳中的储罐的储罐安装装置。每个隆起部分包括中央切除部分781，当组装外壳部件时该中央切除部分781适于接合在其相对表面上的膜部件，由此把储罐在外壳内锁定到位。锁定程度将由施加到膜上的压力、膜部件的弹性性质、及在隆起与膜部件之间的摩擦力确定。在切除部分的每一侧上，隆起部分包括可有助于把储罐安装在外壳中的直线部分782。直线部分可以接合初始预填充储罐以有助于把它锁定到位，然而，当储罐变空和变扁时，这种夹持可能变弱。相反，当储罐变空时，与膜的接合适于适当地把储罐保持到位。直线部分也可以适于夹持和完全压扁储罐，因而用作辅助安装装置。辅助安装装置(未表示)可以接合和夹持储罐，其它装置(未表示)可以在其它位置处，例如沿焊接边缘765，接合和夹持储罐。In Figure 21 there is shown an exploded view of the cartridge unit 505 of Figure 13, the unit comprising: an upper housing part 507; a lower housing part 508 having a transparent region 509 and a recess 504 receiving a raisedpart 561 extending from the needle unit; A flexible storage tank 760 having a rounded edge portion 762 on which a membrane member 761 is mounted; apump assembly 300 having an actuator and a circuit board (not shown) disposed above the storage tank and including Electronics that control the actuation of the pump. The upper and lower housing components include tank mounting means in the form of opposing upper and lower raised portions 780 adapted to engage and mount a tank located in the housing. Each raised portion includes a central cut-out portion 781 adapted to engage the membrane member on its opposing surface when the housing parts are assembled, thereby locking the canister in place within the housing. The degree of locking will be determined by the pressure applied to the membrane, the elastic properties of the membrane member, and the friction between the protrusion and the membrane member. On each side of the cutout, the raised portion includes a straight portion 782 that may assist in mounting the tank in the housing. The straight portion may engage the initial pre-filled tank to help lock it in place, however, this grip may weaken as the tank becomes empty and flattened. Instead, the engagement with the membrane is adapted to properly hold the tank in place when the tank becomes empty. The straight section can also be adapted to grip and completely flatten the tank, thus serving as an installation aid. Auxiliary mounting devices (not shown) may engage and grip the tank, and other devices (not shown) may engage and grip the tank at other locations, such as along welded edge 765 .

参照图22A，表示连接到储罐上的泵的示意概要，泵包括如下一般特征：与储罐的流体连接件391、储罐390、安全阀392、进口和出口393、394、具有相关活塞396的泵腔室395、及出口397。箭头指示在各个元件之间的流动方向。当活塞向下(在图中)运动时，相对负压建立在泵腔室内部，这将使进口阀打开，并且以后将通过安全阀的敞开初级侧从储罐抽取流体。当活塞向上(在图中)运动时，相对过压建立在泵腔室中，这将使进口阀关闭并使出口阀和安全阀打开，借此流体将从泵腔室通过出口阀和安全阀的次级侧流到出口。显然，在通常的操作中，安全阀在流体的吸入和排出期间允许流体通过，并因而在正常操作期间是“被动的”。然而，在对储罐加压的情况下(如对于柔性储罐可能发生的那样)，在储罐中的升高压力将传递到安全阀的初级侧和经泵腔室到安全阀的次级侧，在这种情况下，在安全阀的初级侧的压力将防止次级侧打开。Referring to Figure 22A, a schematic overview of a pump connected to a tank is shown, the pump including the following general features:fluid connection 391 to the tank,tank 390,safety valve 392, inlet andoutlet 393, 394, with associatedpiston 396pump chamber 395, andoutlet 397. Arrows indicate the direction of flow between the various elements. As the piston moves downwards (in the diagram), a relative negative pressure builds up inside the pump chamber which will cause the inlet valve to open and will later draw fluid from the tank through the open primary side of the relief valve. As the piston moves upwards (in the diagram), a relative overpressure builds up in the pump chamber, which closes the inlet valve and opens the outlet and relief valves, whereby fluid passes from the pump chamber through the outlet and relief valves The secondary side flows to the outlet. Obviously, in normal operation, the safety valve allows the passage of fluid during intake and discharge of fluid, and is thus "passive" during normal operation. However, in the event of pressurization of the tank (as may happen with flexible tanks), the elevated pressure in the tank will be passed to the primary side of the safety valve and via the pump chamber to the secondary side of the safety valve. side, in which case the pressure on the primary side of the relief valve will prevent the secondary side from opening.

在图22B中，表示利用在图22A中描绘的泵原理的泵组件300的分解视图，泵组件(下面也称作泵)适于与图1-13的储罐单元一起使用。泵是包括活塞致动泵隔膜的隔膜泵，该活塞致动泵隔膜具有流量控制进口和出口阀。泵具有包括第一、第二及第三部件301、302、303的一般分层构造，在这些部件之间插入第一和第二隔膜层311、312，借此泵腔室341由第一和第二部件与第一隔膜层组合地形成，安全阀345由第一和第三部件与第一隔膜层组合地形成，及进口和出口阀342、343由第二和第三部件与第二隔膜层组合地形成(见图22C)。诸层由外部夹具310以堆叠布置保持。泵还包括进口321和出口322以及连接开口323，这三个都由把泵的内部密封在初始无菌状态下的相应隔膜331、332、333覆盖。隔膜可由穿过给定密封件引入的针或其它部件透过或刺穿(例如，由纸制成)。出口还包括允许泵连接到出口针上的自密封、针可透过膜334(例如，橡胶状材料的)。如在图22C中表示的那样，流体通道(由黑线指示)经安全阀345的初级侧形成在进口321(见下面)与进口阀342之间，形成在进口阀、泵腔室345与出口阀343之间，及经安全阀的次级侧形成在出口阀与出口322之间，流体通道形成在不同的层中或其之间。泵也包括用来致动泵隔膜的活塞340，活塞由外部驱动装置(未表示)驱动。In Fig. 22B, there is shown an exploded view of apump assembly 300 utilizing the pump principle depicted in Fig. 22A, the pump assembly (hereinafter also referred to as pump) adapted for use with the tank unit of Figs. 1-13. The pump is a diaphragm pump including a piston actuated pump diaphragm with flow control inlet and outlet valves. The pump has a generally layered construction comprising first, second andthird parts 301, 302, 303 between which are interposed first and second diaphragm layers 311, 312 whereby thepump chamber 341 is separated by the first and The second part is formed in combination with the first diaphragm layer, thesafety valve 345 is formed in combination with the first and third parts and the first diaphragm layer, and the inlet andoutlet valves 342, 343 are formed in combination with the second and third parts and the second diaphragm layer. The layers are formed in combination (see Figure 22C). The layers are held in a stacked arrangement byexternal clamps 310 . The pump also comprises aninlet 321 and anoutlet 322 and aconnection opening 323, all three covered byrespective membranes 331, 332, 333 which seal the interior of the pump in an initially sterile state. The septum may be penetrated or pierced (eg, made of paper) by a needle or other component introduced through a given seal. The outlet also includes a self-sealing, needle-permeable membrane 334 (eg, of a rubber-like material) that allows a pump to be connected to the outlet needle. As shown in FIG. 22C, a fluid passage (indicated by a black line) is formed between the inlet valve 321 (see below) and theinlet valve 342 via the primary side of therelief valve 345, between the inlet valve, thepump chamber 345 and the outlet valve. Between thevalves 343, and the secondary side via the safety valve is formed between the outlet valve and theoutlet 322, fluid passages are formed in or between different layers. The pump also includes apiston 340 for actuating the pump diaphragm, the piston being driven by an external drive (not shown).

泵还包括可滑动地定位在针腔室360中的空心连接针350形式的流体连接器，该针腔室360布置在连接开口后面，见图22D。针腔室穿过泵的诸层形成，并且包括内部密封膜315，穿过该膜315可滑动地布置针，所述膜由第一隔膜层形成。针包括尖远端351、其上布置针活塞352的近端、及与远端流动连通的近侧开口353，针和活塞相对于内部隔膜和腔室可滑动地布置。如由图22D可理解的那样，在其初始位置的针活塞由一个或多个径向布置的键槽359旁通。提供这些以便允许蒸汽灭菌和通风，否则当流体连接器在针腔室中向前运动时捕获空气。The pump also includes a fluid connector in the form of ahollow connection needle 350 slidably positioned in aneedle chamber 360 arranged behind the connection opening, see Fig. 22D. The needle chamber is formed through the layers of the pump and includes aninner sealing membrane 315 through which the needle is slidably disposed, said membrane being formed by the first septum layer. The needle includes a pointeddistal end 351 , a proximal end on which aneedle piston 352 is disposed, and aproximal opening 353 in flow communication with the distal end, the needle and piston being slidably disposed relative to the internal septum and chamber. As can be appreciated from FIG. 22D , the needle piston in its initial position is bypassed by one or more radially arrangedkeyways 359 . These are provided to allow for steam sterilization and venting that would otherwise trap air as the fluid connector moves forward in the needle chamber.

上述泵组件可以提供在图1-20中表示的类型的药品输送器械中。在其中储罐单元附连到针单元上的使用情形下，输液针的近端532穿过泵的出口密封件和膜334引入，并且致动器515(见图19)穿过连接隔膜333引入。通过这种动作，连接针从在图22D中表示的其初始位置推到在图22E中表示的致动位置，在该致动位置中，远端穿过进口隔膜331和进一步穿过靠近储罐布置的针可透过膜运动，这样经由针中的近开口353在储罐与进口阀之间建立了流动通道。在这个位置中，密封件形成在针活塞与针腔室之间。The pump assembly described above may be provided in a drug delivery device of the type shown in Figures 1-20. In a use situation where the reservoir unit is attached to the needle unit, theproximal end 532 of the infusion needle is introduced through the outlet seal and membrane 334 of the pump, and the actuator 515 (see FIG. 19 ) is introduced through the connectingseptum 333 . By this action, the connecting needle is pushed from its initial position shown in Figure 22D to the actuated position shown in Figure 22E, in which the distal end passes through theinlet septum 331 and further through The needle is arranged to move through the membrane such that a flow channel is established between the reservoir and the inlet valve via theproximal opening 353 in the needle. In this position, a seal is formed between the needle piston and the needle chamber.

显然，当两个单元脱开时，输液针的近端532从泵出口退出，而连接针永久地提供泵与储罐之间的流体连通。Obviously, when the two units are disconnected, theproximal end 532 of the infusion needle is withdrawn from the pump outlet, while the connecting needle permanently provides fluid communication between the pump and the reservoir.

在上述实施例中，经皮器械为整体针器械的形式(例如，所表示的输液针或针传感器(未表示))，然而，经皮器械也可以为与插入针组合的插管或传感器的形式，该插入针在其插入之后退出。例如，第一针部分可以为(比较软的)输注插管(例如，Teflon插管)和贯穿布置的可除去的插入针的形式。这种类型的插管针布置从所谓的输液组件是熟知的，这样的输液组件典型地用来与(耐用的)输液泵相组合地提供输液地点。In the above embodiments, the percutaneous device is in the form of an integral needle device (e.g., an infusion needle or a needle sensor (not shown) shown), however, the percutaneous device may also be a cannula or sensor combined with an insertion needle. form, the insertion needle exits after its insertion. For example, the first needle portion may be in the form of a (relatively soft) infusion cannula (eg, a Teflon(R) cannula) and a removable insertion needle disposed therethrough. Cannula needle arrangements of this type are well known from so-called infusion sets, which are typically used in combination with (durable) infusion pumps to provide an infusion site.

因而，图23A和23B示意地表示插管和插入针组合如何可布置在给定医疗器械600(部分表示)，例如输液器械或输液组件中的外壳601内。更明确地说，该医疗器械包括经皮组件650，该经皮组件650包括由下部部件653携带的比较软插管651(它例如可以是软Teflon插管类型的)、和可滑动地布置在插管内并且由上部部件663携带的尖插入针661(例如，由医疗级不锈钢制成)的组合，两个部件安装成允许插管、插入针相应地轴向移动。插管包括允许它与或布置成与流体源流体连通的近进口(未表示)。医疗器械还包括具有用于插管的开口621以及释放部件622的基座板620。下部部件包括弹性体密封件652，穿过该弹性体密封件652布置插入针。插管和插入针依据两个部件在器械中如何安装可以是直的或弯曲的，例如与枢转轴线相对应的弓形或与直线运动相对应的直线，如表明的那样。上部部件包括把部件一起锁定在初始位置中的联接部件667，使插入针的远端从插管的远开口延伸，如在图23A中表示的那样，并且基板包括用来把下部部件锁定在延伸位置中的联接部件657，使插管的远端穿过基座板中的开口延伸(见图23B)。在器械的外壳与上部部件之间，第一弹簧668布置成向上偏置上部部件。对应地，器械也包括向上偏置下部部件的第二弹簧658。医疗器械还包括与在图1中图示的实施例相对应的握持拉片676和拉动部件677。Thus, Figures 23A and 23B schematically illustrate how a cannula and insertion needle combination may be arranged within a housing 601 in a given medical device 600 (shown in part), such as an infusion set or infusion set. More specifically, the medical device includes a percutaneous assembly 650 comprising a relatively soft cannula 651 (which may be, for example, of the soft Teflon(R) cannula type) carried by a lower part 653, and slidably arranged A combination of pointed insertion needle 661 (eg, made of medical grade stainless steel) within the cannula and carried by upper part 663, the two parts are mounted to allow corresponding axial movement of the cannula, insertion needle. The cannula includes a proximal port (not shown) that allows it to be in fluid communication with or arranged to be in fluid communication with a fluid source. The medical device also includes a base plate 620 having an opening 621 for the cannula and a release member 622 . The lower part includes an elastomeric seal 652 through which the insertion needle is arranged. The cannula and insertion needle can be straight or curved depending on how the two parts are mounted in the instrument, eg arcuate corresponding to a pivot axis or straight corresponding to linear movement, as indicated. The upper part includes a coupling part 667 that locks the parts together in an initial position, allowing the distal end of the insertion needle to extend from the distal opening of the cannula, as shown in FIG. The coupling member 657 is in position such that the distal end of the cannula extends through the opening in the base plate (see Figure 23B). Between the housing of the instrument and the upper part, a first spring 668 is arranged to bias the upper part upwards. Correspondingly, the instrument also includes a second spring 658 that biases the lower part upwards. The medical device also includes a grip tab 676 and a pull member 677 corresponding to the embodiment illustrated in FIG. 1 .

在使用的情形下，组件或者手动地或者通过可释放插入帮助，例如穿过在外壳中的开口作用的弹簧加载部件(未表示)，向下运动，借此使具有伸出插入针的插管穿过对象的皮肤插入。在这个位置中，下部部件接合联接部件657，由此把插管锁定在其延伸位置，就像联接部件667由释放部件622释放那样，由此允许上部部件借助于第一弹簧返回其初始位置。In the case of use, the assembly is moved downwards either manually or by a releasable insertion aid, such as a spring-loaded member (not shown) acting through an opening in the housing, whereby the cannula with the protruding insertion needle Inserted through the subject's skin. In this position, the lower part engages the coupling part 657, thereby locking the cannula in its extended position, as the coupling part 667 is released by the release part 622, thereby allowing the upper part to return to its original position by means of the first spring.

当用户打算从表面除去输送器械时，用户握住拉片的握持部分并且在大体与皮肤表面相平行的第一方向上拉动它，通过该动作，柔性带条677从下部部件释放联接部件657，借此下部部件以及由此插管借助于第二弹簧缩回。当插管已经从皮肤退回时，用户使用新的展开拉片以从皮肤表面拉开整个输送器械，例如通过在远离皮肤表面的方向上拉动该拉片。When the user intends to remove the delivery device from the surface, the user grasps the grip portion of the tab and pulls it in a first direction generally parallel to the skin surface, by which action the flexible strap 677 releases the coupling member 657 from the lower part , whereby the lower part and thus the cannula are retracted by means of the second spring. When the cannula has been withdrawn from the skin, the user uses the new deployment tab to pull the entire delivery device away from the skin surface, for example by pulling the tab in a direction away from the skin surface.

在图24中，表示参照图1-12描述的适用于以后安装过程的器械的实施例(即，首先安装针单元)。In Fig. 24, an embodiment of the instrument described with reference to Figs. 1-12 is shown which is suitable for a later installation process (ie the needle unit is installed first).

更明确地说，图24表示药品输送器械100形式的医疗器械的立体图，该药品输送器械100包括针外壳110、具有适于施加到对象的皮肤上的下部安装表面133的基座部件130、及分离泵单元150。在图示的实施例中，基座部件包括附连到较柔性的粘合贴片部件132上的较刚性上部部分131，该粘合贴片部件132具有提供安装表面本身的下部粘合表面。针外壳可以与基座部件整体地形成，或者作为分离单元附连到其上，两个元件组合地形成平台单元。在图示的实施例中，针单元包括外壳111，在该外壳111内，枢转地布置空心针112。More particularly, FIG. 24 shows a perspective view of a medical device in the form of a drug delivery device 100 comprising a needle housing 110, a base member 130 having a lower mounting surface 133 adapted to be applied to the skin of a subject, and The pump unit 150 is separated. In the illustrated embodiment, the base member includes a relatively rigid upper portion 131 attached to a relatively flexible adhesive patch member 132 having a lower adhesive surface that provides the mounting surface itself. The needle housing may be formed integrally with the base part, or attached thereto as a separate unit, the two elements in combination forming the platform unit. In the illustrated embodiment, the needle unit comprises a housing 111 within which a hollow needle 112 is pivotally arranged.

外壳包括由第一和第二盖装置覆盖的第一和第二开口(或窗口)。在图示的实施例中，第一盖装置为针可透过橡胶隔膜121的形式，并且第二盖隔膜为允许元件被引入到外壳的内部中的可刺穿纸片的形式。纸片对于灭菌气体是可透过的，纸片、橡胶隔膜及外壳组合地提供用于封装针部分的无菌隔离。The housing includes first and second openings (or windows) covered by first and second cover means. In the illustrated embodiment the first cover means is in the form of a needle permeable rubber septum 121 and the second cover septum is in the form of a pierceable paper sheet allowing the element to be introduced into the interior of the housing. The paper sheet is permeable to sterilizing gases and the paper sheet, rubber septum and housing in combination provide a sterile barrier for enclosing the needle portion.

针包括：第一针部分113，具有适于透入对象的皮肤的第一尖端，第一针部分大体与安装表面相垂直地延伸；和第二针部分114，与第一针部分经中间针部分115流体连通，并且具有第二尖端，第二针部分大体与安装表面相平行地布置。针由安装部件117连接到外壳上，允许针与由第二针部分限定的轴线相对应地枢转，借此针可在其中第一针部分相对于安装表面缩回的初始无菌位置与其中第一针部分的尖端穿过橡胶隔膜和相对于安装表面伸出的第二位置之间运动。外壳也包括向初始位置偏置针的偏置部件118。通常，针的“下游”部分(这里：第一部分)被称作远部分，并且针的“上游”部分(这里：第二部分)被称作近部分。The needle comprises: a first needle part 113 having a first tip adapted to penetrate the subject's skin, the first needle part extending generally perpendicular to the mounting surface; Portion 115 is in fluid communication and has a second tip, the second needle portion being disposed generally parallel to the mounting surface. The needle is connected to the housing by a mounting member 117, allowing the needle to pivot correspondingly to an axis defined by the second needle portion, whereby the needle can be in an initial sterile position in which the first needle portion is retracted relative to the mounting surface and wherein The tip of the first needle portion moves between passing through the rubber septum and protruding relative to the mounting surface to a second position. The housing also includes a biasing member 118 that biases the needle towards the initial position. Usually, the "downstream" part of the needle (here: the first part) is called the distal part, and the "upstream" part of the needle (here: the second part) is called the proximal part.

储罐(或泵)单元150包括其中布置储罐和排出装置的外壳。储罐适于容纳流体药品(例如，预填充或适于由用户填充)，并且包括适于布置成与第二针部分流体连通的突出针可透过膜155形式的出口装置。排出装置(未表示)适于在使用情形下从储罐和穿过对象的皮肤经空心针排出药品。泵单元还包括相邻储罐出口布置的斜面部件156。储罐和排出装置可以具有任何适当的构造，例如像参照图25A-25D公开的那样。The tank (or pump) unit 150 comprises a housing in which the tank and discharge are arranged. The reservoir is adapted to contain a fluid medicament (eg, pre-filled or adapted to be filled by a user) and includes outlet means in the form of a protruding needle-permeable membrane 155 adapted to be arranged in fluid communication with the second needle portion. The discharge means (not shown) is adapted to discharge the drug from the reservoir and through the skin of the subject through the hollow needle in the case of use. The pump unit also includes a ramp member 156 arranged adjacent to the outlet of the tank. The storage tank and drain may have any suitable configuration, for example as disclosed with reference to Figures 25A-25D.

安装平台包括接收部分，接收部分和泵单元包括允许泵单元固定到平台单元上的配对联接装置160。该配对联接装置是可释放的，允许耐用或多次使用泵单元附连到一次性平台单元上多次。The mounting platform includes a receiving portion, the receiving portion and the pump unit including mating coupling means 160 allowing the pump unit to be secured to the platform unit. The mating coupling means are releasable, allowing the durable or multi-use pump unit to be attached to the disposable platform unit multiple times.

在使用情形中，平台单元安装在用户皮肤上(例如，通过布置在安装表面上的粘合装置)，并且泵单元通过使它大体与安装表面相平行地滑动成与平台单元接合而附连和锁定到平台单元上。在以后的操作期间，将突出膜和斜面部件移动成与针接合，由此破坏纸阻挡盖122，在该操作期间，在第二针部分与储罐之间建立流体连通，就像针从其初始位置到其第二位置枢转那样，第一尖针端由此穿透橡胶隔膜和用户皮肤。In a use situation, the platform unit is mounted on the user's skin (for example, by adhesive means disposed on the mounting surface), and the pump unit is attached and attached by sliding it generally parallel to the mounting surface into engagement with the platform unit. Locks to platform unit. During a later operation, the protruding membrane and ramp member are moved into engagement with the needle, thereby breaking the paper barrier cover 122, during which fluid communication is established between the second needle portion and the reservoir, just as the needle exits it. As the initial position pivots to its second position, the first sharp needle end thereby penetrates the rubber septum and the user's skin.

在泵单元已经连接和经皮将针引入之后，可启动泵。这可以当连接两个单元时自动地发生，或者通过分离的用户可致动启动装置，例如启动按钮(未表示)发生。After the pump unit has been connected and the needle introduced percutaneously, the pump can be activated. This can happen automatically when the two units are connected, or by a separate user-actuatable activation means, such as an activation button (not shown).

在可选择实施例(未表示)中，第二针部分可以固定地(即，非转动地)附连到安装部件117上，中间针部分115在它由斜面部件156强迫向下时被弹性弯曲。在这样一种布置中，可以省去偏置部件118。In an alternative embodiment (not shown), the second needle portion may be fixedly (i.e., non-rotatably) attached to the mounting member 117, the intermediate needle portion 115 being resiliently bent as it is forced downward by the ramp member 156. . In such an arrangement, biasing member 118 may be omitted.

在上述实施例中，已经描述了一种包括与排出装置的例子相组合的柔性储罐的输送装置。然而，储罐和排出装置可以是适于布置在皮肤可安装药品输送器械内的任何类型。而且，由于本发明的针也可以为针传感器的形式，所以医疗器械的内部可以包括适于与针传感器合作的传感器装置。In the above-described embodiments, a delivery device including a flexible storage tank combined with an example of a discharge device has been described. However, the reservoir and discharge means may be of any type suitable for placement within a skin-mountable drug delivery device. Furthermore, since the needle of the present invention may also be in the form of a needle sensor, the interior of the medical device may comprise sensor means adapted to cooperate with the needle sensor.

在图25A-25E中，示意表示适于与本发明一起使用的排出装置的例子，然而，这些仅仅是例子，就像各个元件的表示布置不必适于在以上表示的输送器械中的直接应用那样。更明确地说，图25A表示泵装置，该泵装置包括：药品容纳筒1010，形成储罐，并且具有允许与针连接的远封闭部件1011、和滑动地布置其内的活塞1015；柔性带齿活塞杆1020(例如，如在美国专利6,302,869中公开的那样)；电动机1030，它经蜗轮装置1031驱动活塞杆以从筒排出药品，电机由控制装置1040控制，并且用于控制装置和电机的能量由电池1050提供。当在插入物已经与输送器械脱开之后(通过未表示的装置)或通过分离的用户可致动装置(未表示)插入针时，可以致动所述泵。In Figures 25A-25E, examples of expulsion devices suitable for use with the present invention are schematically represented, however, these are merely examples, as the representational arrangement of the individual elements is not necessarily suitable for direct application in the delivery apparatus represented above . More specifically, FIG. 25A shows a pump device comprising: adrug containing cartridge 1010 forming a reservoir and having adistal closure member 1011 allowing connection with a needle and apiston 1015 slidably disposed therein; a flexible toothed Piston rod 1020 (for example, as disclosed in U.S. Patent 6,302,869);electric motor 1030, which drives the piston rod viaworm gear 1031 to expel drug from the cartridge, the motor is controlled by thecontrol device 1040 and is used to control the power of the device and the motor Provided bybattery 1050. The pump may be actuated when the needle is inserted after the insert has been disengaged from the delivery device (by means not shown) or by a separate user actuatable means (not shown).

图25B表示泵装置，该泵装置包括：药品容纳筒1110，具有远和近封闭部件1111、1112、和滑动地布置其内的活塞1115；气体产生装置1120，与筒的内部经导管1121流体连通，用来驱动活塞以从所述筒排出药品，气体产生装置由控制装置1140控制，并且用于控制装置和气体产生的能量由电池1150提供。泵如上指示的那样可以致动。用于药品输送器械的这种气体产生装置的详细公开可在例如美国专利5,858,001中找到。Figure 25B shows a pump device comprising: adrug containing cartridge 1110 having distal andproximal closure members 1111, 1112, and apiston 1115 slidably disposed therein; agas generating device 1120 in fluid communication with the interior of the cartridge via aconduit 1121 , used to drive the piston to expel the drug from the cartridge, the gas generating device is controlled by thecontrol device 1140 and the power for the control device and gas generation is provided by thebattery 1150 . The pump can be actuated as indicated above. A detailed disclosure of such a gas generating device for a drug delivery device can be found, for example, in US Patent No. 5,858,001.

图25C表示泵装置，该泵装置包括：药品容纳筒1210，具有远和近封闭部件1211、1212、和滑动地布置其内的活塞1215；渗透引擎1220，与筒的内部经导管1221流体连通，用来驱动活塞以从筒排出药品。渗透引擎包括包含盐溶液的第一刚性储罐1225、和包含水的第二可压扁储罐1226，两个储罐由半透膜1227分离。当供给用户时，在第二储罐与隔膜之间的流体连接件1228由用户可切断隔膜(例如，弱焊接)封闭，该隔膜当切断时，将允许渗透过程开始，因为水从第二储罐穿过隔膜并进入第一储罐抽吸。泵如以上指示的那样可以致动。渗透驱动原理的详细公开可在例如美国专利5,169,390中找到。Figure 25C shows a pump device comprising: adrug containing cartridge 1210 having distal andproximal closure members 1211, 1212, and apiston 1215 slidably disposed therein; anosmotic engine 1220 in fluid communication with the interior of the cartridge via aconduit 1221, Used to drive the piston to expel the drug from the barrel. The osmotic engine comprises a firstrigid tank 1225 containing a saline solution, and a secondcollapsible tank 1226 containing water, the two tanks being separated by asemi-permeable membrane 1227 . When supplied to the user, thefluid connection 1228 between the second reservoir and the membrane is closed by a user severable membrane (e.g., a weak weld) which, when severed, will allow the permeation process to begin as water flows from the second reservoir. The tank is pumped through the diaphragm and into the first storage tank. The pump can be actuated as indicated above. A detailed disclosure of osmotic drive principles can be found, for example, in US Patent No. 5,169,390.

图25D表示泵装置，该泵装置包括布置在刚性的流体填充次级储罐1311内的药品容纳柔性储罐1310，该次级储罐1311通过包括流动限制器1331的导管1330与初级储罐1320流体连通。初级储罐为具有可运动活塞1321的筒的形式，并且容纳有粘性驱动流体。弹簧1340布置成作用于活塞以从第一到第二储罐驱动流体，由此当柔性储罐连接到输液针(未表示)上时从柔性储罐排出药品。流量可以由在驱动流体中由弹簧产生的压力、驱动流体的粘度及在流动限制器中的流动阻力(即，流出孔原理)确定。当在插入物已经与输送器械脱开之后(通过未表示的装置或)通过分离的用户可致动装置(未表示)将针插入时，泵可以通过拉紧弹簧或通过释放预应力弹簧而被致动。用于药品输注的这种原理的例子从DE 2552446得知。在可选择构造中，可以直接对药品储罐进行加压以经流动限制器排出药品，例如如在美国专利6,074,369中公开的那样。25D shows a pump arrangement comprising a drug-containingflexible reservoir 1310 disposed within a rigid, fluid-filledsecondary reservoir 1311 connected to aprimary reservoir 1320 via aconduit 1330 comprising aflow restrictor 1331. fluid communication. The primary tank is in the form of a cartridge with amovable piston 1321 and contains a viscous drive fluid. Thespring 1340 is arranged to act on the piston to drive fluid from the first to the second reservoir, thereby expelling the drug from the flexible reservoir when the flexible reservoir is connected to an infusion needle (not shown). The flow rate can be determined by the pressure in the drive fluid created by the spring, the viscosity of the drive fluid, and the resistance to flow in the flow restrictor (ie, the orifice principle). When the needle is inserted after the insert has been disengaged from the delivery device (by means not shown or) by a separate user actuatable means (not shown), the pump can be activated by tensioning the spring or by releasing a prestressed spring. actuate. An example of this principle for drug infusion is known from DE 2552446. In an alternative construction, the drug storage tank may be pressurized directly to expel the drug through a flow restrictor, such as disclosed in US Patent No. 6,074,369.

图26示出了与图1-11的实施例相对应的医疗器械900，然而，储罐单元具有包括适于安装在储罐单元920上的“耐用”控制单元910的模块结构，该储罐单元920包括储罐和由控制单元通过触点921可控制的排出组件。经皮器械单元930可以与在图1-11中的相同。经皮器械单元和储罐单元包括允许储罐单元固定到经皮器械单元上以提供储罐与经皮器械之间的流体连通的配对联接装置(931)，控制器单元和储罐单元包括允许控制器单元固定到储罐单元上以控制排出组件的配对联接装置(917、921)。控制单元可以包括如下特征的一个或多个：振荡器、RF发射器、RF接收器、显示器、药团按钮918(如表示的那样)或其它用户输入装置、备用电池、存储器。而且，控制单元可以适于提供固定流量，或者它可以是可编程的(例如，经远程控制)以提供给定速率或给定分布。不同的控制单元也可以与不同的储罐单元(例如，包括不同的药品或不同量的药品)、或者与不同的针单元(例如，包括针或软插管)一起使用。如以上叙述的那样，控制器可以由用户用作耐用器械，然而，(较简单)控制器样式可以预附加到储罐单元上，并且可以用作提供各种一次性器械的装置。Figure 26 shows amedical device 900 corresponding to the embodiment of Figures 1-11, however, the tank unit has a modular construction comprising a "durable"control unit 910 adapted to be mounted onUnit 920 comprises a tank and a discharge assembly controllable by the control unit viacontact 921 . Thepercutaneous instrument unit 930 may be the same as in FIGS. 1-11. The percutaneous device unit and the reservoir unit include mating coupling means (931) allowing the reservoir unit to be secured to the percutaneous device unit to provide fluid communication between the reservoir and the percutaneous device, the controller unit and the reservoir unit including allowing A controller unit is secured to the tank unit to control the mating couplings (917, 921) of the discharge assembly. The control unit may include one or more of the following features: oscillator, RF transmitter, RF receiver, display, bolus button 918 (as shown) or other user input device, battery backup, memory. Also, the control unit may be adapted to provide a fixed flow rate, or it may be programmable (eg via remote control) to provide a given rate or a given distribution. Different control units may also be used with different reservoir units (eg comprising different medicaments or different amounts of medicaments), or with different needle units (eg comprising needles or soft cannulas). As stated above, the controller can be used as a durable instrument by the user, however, the (simpler) controller version can be pre-attached to the tank unit and can be used as a means of providing various disposable instruments.

图27表示除基本针贴片单元930和基本储罐单元920之外包括多个不同类型的控制单元的模块系统。远程控制器940可以与控制单元的某些相组合地使用。控制单元可以处于只可由远程控制器控制的远程可控制单元911的形式。其变形912可以添加药团按钮918，允许用户用药团而不必使用远程控制器。控制单元可以提供成各种编程控制单元913，每个提供在单元上所指示的固定流量。这样一种单元打算用于没有远程控制器的用途，并且可以包括所表示的显示器919。也可以提供可编程控制单元914，这允许例如开业医师针对单个病人为控制单元编程。模型915代表与储罐单元和针单元相组合的公开控制单元的任一种。FIG. 27 shows a modular system comprising a number of different types of control units in addition to a basicneedle patch unit 930 and abasic tank unit 920 . The remote controller 940 may be used in combination with some of the control units. The control unit may be in the form of a remotely controllable unit 911 which is only controllable by a remote controller. A variation 912 of this could add abolus button 918, allowing the user to take a bolus without having to use a remote control. The control unit may be provided as various programmed control units 913, each providing a fixed flow rate indicated on the unit. Such a unit is intended for use without a remote control and may include a display 919 as indicated. A programmable control unit 914 may also be provided, which allows, for example, a medical practitioner to program the control unit for an individual patient. Model 915 represents any of the disclosed control units combined with a tank unit and a needle unit.

在优选实施例的以上描述中，为不同元件提供描述的功能性的不同结构和装置，已经描述到本发明的概念对于是本领域技术人员的读者显然的程度。用于不同元件的详细构造和详述被认为是，由本领域的技术人员沿在本说明书中叙述的路线进行的通常设计过程的目的。In the above description of the preferred embodiments, different structures and arrangements of described functionality have been provided for different elements, to the extent that the concepts of the present invention are apparent to the reader who is skilled in the art. The detailed construction and elaboration for the different elements are considered the object of a usual design process by a person skilled in the art along the lines set forth in this specification.

Claims (14)

Translated fromChinese

1.一种医疗器械，包括：1. A medical device, comprising:-储罐(760)，适于在其内部容纳流体药品，- a storage tank (760), adapted to contain a fluid medicine inside it,-泵组件(300)，包括：- a pump assembly (300), comprising:-泵进口(321)、泵出口(322)及布置在它们之间的内部流动通道(341、342、343)，- pump inlet (321), pump outlet (322) and internal flow channels (341, 342, 343) arranged between them,-流体连接器(350)，包括进口(351)和出口(353)，- fluid connector (350), comprising inlet (351) and outlet (353),-其中，流体连接器布置成从初始状态和致动状态操作，在该初始状态下，流体连接器布置在泵的内部，在该致动状态下，在储罐的内部与泵组件的内部之间经由流体连接器建立流体连通，并且流体连接器的出口布置在泵组件的流动通道中。- wherein the fluid connector is arranged to operate from an initial state in which the fluid connector is arranged inside the pump and an actuated state between the interior of the tank and the interior of the pump assembly The fluid communication between them is established via a fluid connector, and the outlet of the fluid connector is arranged in the flow channel of the pump assembly.2.根据权利要求1所述的医疗器械，其中，泵进口和泵出口包括在初始状态下密封泵的内部并由此把流动通道和流体连接器密封在初始无菌状态下的密封件。2. The medical device of claim 1, wherein the pump inlet and the pump outlet comprise seals that in an initial state seal the interior of the pump and thereby seal the flow channel and fluid connectors in an initial sterile state.3.根据权利要求1所述的医疗器械，包括允许外部部件与流体连接器接合以由此从初始状态到致动状态操作流体连接器的致动开口。3. The medical device of claim 1, comprising an actuation opening that allows the outer member to engage the fluid connector to thereby operate the fluid connector from the initial state to the actuated state.4.根据权利要求3所述的医疗器械，其中，泵进口、泵出口及致动开口包括在初始状态下密封泵的内部并由此把流动通道和流体连接器密封在初始无菌状态下的密封件。4. The medical device of claim 3, wherein the pump inlet, the pump outlet, and the actuation opening include seals that initially seal the interior of the pump and thereby seal the flow channels and fluid connectors in an initial sterile state. Seals.5.根据权利要求1-4中任一项所述的医疗器械，其中，流体连接器包括尖的进口端，储罐包括允许尖的流体连接器进口端插入穿过的可透过部分(761)。5. The medical device according to any one of claims 1-4, wherein the fluid connector includes a pointed inlet end, and the reservoir includes a permeable portion (761 ) that allows the pointed fluid connector inlet end to be inserted therethrough. ).6.根据权利要求5所述的医疗器械，其中，储罐的可透过部分包括自密封针可透过膜。6. The medical device of claim 5, wherein the permeable portion of the reservoir comprises a self-sealing needle permeable membrane.7.根据以上权利要求中任一项所述的医疗器械，其中，流动通道包括可变体积泵腔室。7. A medical device according to any one of the preceding claims, wherein the flow channel comprises a variable volume pump chamber.8.根据权利要求7所述的医疗器械，其中，流动通道还包括与泵进口相联的进口阀和与泵出口相联的出口阀。8. The medical device of claim 7, wherein the flow channel further comprises an inlet valve associated with the pump inlet and an outlet valve associated with the pump outlet.9.根据以上权利要求中任一项所述的医疗器械，其中，泵出口包括允许一尖的经皮器械插入穿过的自密封针可透过膜。9. A medical device according to any one of the preceding claims, wherein the pump outlet comprises a self-sealing needle permeable membrane allowing insertion of a pointed percutaneous instrument therethrough.10.根据以上权利要求中任一项所述的医疗器械，还包括用来致动泵组件的致动器。10. A medical device according to any one of the preceding claims, further comprising an actuator for actuating the pump assembly.11.根据以上权利要求中任一项所述的医疗器械，还包括具有适于透过对象皮肤的尖端的经皮器械(530)，该经皮器械布置成或适于布置成与泵出口流体连通。11. The medical device according to any one of the preceding claims, further comprising a percutaneous device (530) having a tip adapted to penetrate the subject's skin, the percutaneous device being arranged or adapted to be arranged in contact with the pump outlet fluid connected.12.一种包括根据权利要求1-10中任一项所述的医疗器械的医疗组件，还包括经皮器械单元(502)，该经皮器械单元包括：12. A medical assembly comprising the medical device according to any one of claims 1-10, further comprising a percutaneous device unit (502), the percutaneous device unit comprising:-经皮器械(530)，包括适于透过对象的皮肤的尖端，- a percutaneous device (530) comprising a tip adapted to penetrate the skin of a subject,-安装表面(571)，适于施加到对象的皮肤上，- a mounting surface (571) suitable for application to the subject's skin,-其中，所述经皮器械单元和医疗器械适于在使用的情形下彼此固定，并且- wherein the percutaneous device unit and the medical device are adapted to be fixed to each other in the situation of use, and-其中，所述经皮器械适于布置成与泵出口流体连通。- wherein said percutaneous device is adapted to be arranged in fluid communication with a pump outlet.13.根据权利要求12所述的医疗组件，其中，当经皮器械单元和医疗器械彼此固定时，在经皮器械与泵组件之间建立流体连通。13. The medical assembly of claim 12, wherein fluid communication is established between the percutaneous device and the pump assembly when the percutaneous device unit and the medical device are secured to each other.14.根据权利要求11或12所述的医疗组件，其中，当经皮器械单元和医疗器械彼此固定时，流体连接器从初始状态到致动状态被操作。14. The medical assembly according to claim 11 or 12, wherein the fluid connector is operated from an initial state to an actuated state when the percutaneous device unit and the medical device are secured to each other.

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