CN102883761B - 筒和筒连接组件的组合以及相关方法 - Google Patents

筒和筒连接组件的组合以及相关方法 Download PDF

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CN102883761B
CN102883761B CN201180006571.0A CN201180006571A CN102883761B CN 102883761 B CN102883761 B CN 102883761B CN 201180006571 A CN201180006571 A CN 201180006571A CN 102883761 B CN102883761 B CN 102883761B
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奥兹·卡比里
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2422—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/2425—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by compression of deformable ampoule or carpule wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M2005/14506—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons mechanically driven, e.g. spring or clockwork
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/1456—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir

Abstract

一种筒连接组件（80），其特征在于，包括外轴（84）的驱动柱塞（82）、以及包括能相对于外轴（84）伸缩地移动的内轴（88）的驱动器（86），其中，驱动器（86）的旋转导致驱动柱塞（82）在远离驱动器（86）的方向上前进，并且其中，筒连接组件（80）插入到筒（22）中，该筒中滑动地设置有柱塞（24），并且驱动器（86）的旋转导致驱动柱塞（82）在筒（22）中朝着远端前进直至抵靠柱塞（24）。

Description

筒和筒连接组件的组合以及相关方法
技术领域
本发明总体上涉及外部药泵(externaldrugpump)，特别地涉及一种用于将药从筒(cartridge)中推出的组件，其中该组件连接(interface)在致动器(例如电机)与推动装置(例如筒中的柱塞)之间。
背景技术
外部药泵典型地用于向患者输送含有口服时不能消化的大分子(诸如胰岛素)的物质。典型地，该泵附着于患者的腹部并通过插入到患者的皮肤中的插管或针将物质输送给患者。
Gross和Cabiri的PCT专利申请PCT/IL2008/001312(以WO2009/044401公布)(以及美国专利申请12/244666和12/244668，将其公开内容通过引证结合于此)描述了一种外部药泵。在该泵中，设置有装有待给受治疗者服用的物质的筒。(在整个说明书和权利要求书中，术语“药”和“物质”可互换地使用并涵盖给受治疗者服用的任何物质。整个说明书和权利要求书中的术语“筒”涵盖用于药的任何容器，诸如但不限于筒、药水瓶、注射器、瓶、安瓿等，且不限于任何尺寸或形状。)
筒用塞(stopper)密封，并具有彼此螺纹接合的第一和第二螺纹元件(例如螺钉和螺母)。第二螺纹元件的远端限定使第二螺纹元件接合至塞的接合部分。第一螺纹元件可相对于筒旋转，并在第一螺纹元件的旋转期间相对于筒线性地固定。通过电机而旋转的第一螺纹元件构造为使塞和至少第二螺纹元件的远端朝着筒的远端线性地前进，而使第二螺纹元件和塞基本上不旋转。
为了便于对上述组件的理解，提供以下内容。
参照图1，该图示出了WO2009/044401的现有技术筒组件的相关元件(基于该申请的图4)，其中筒22插入到壳体底座中。
筒22的远端插入到筒刺穿机构44中，该筒刺穿机构刺穿位于筒22的其中具有塞24(塞是柱塞、活塞或推动装置的一个实例；塞将被称作柱塞)的远端处的密封件。筒22然后降低到壳体底座中。典型地，相对的弹性臂70将筒支撑在壳体底座上。当筒22降低到壳体底座中时，第一嵌齿(cog)52接合第二嵌齿54。(第一嵌齿52通过电机而旋转，在此未示出)。在一些申请中，在筒22插入到壳体中之前，第一螺纹元件26从筒的近端伸出距离h。第一螺纹元件(或第二嵌齿54)的近端包括圆形部分74。壳体底座的部分34包括倾斜面76。圆形部分74滑过该倾斜面，第一螺纹元件在筒内部被推动距离h。结果，第一和第二螺纹元件26和28以及塞24朝着筒22的远端移动。在操作期间，电机(未示出)使嵌齿52旋转，嵌齿52使嵌齿54旋转。这使塞24朝着筒22的远端线性地前进，从而给予来自筒22的物质。
现在参照图2，该图示出了在筒22已填充之前柱塞24处于初始位置中的筒22。该筒由制造商预填充或由用户填充，诸如使用穿过隔膜17插入到筒22中(图3)或穿过隔膜19插入到药泵的壳体中(图4)的皮下注射器针头15来填充。如图3所示，当填充筒时，柱塞24在筒22中线性地移动。因为诸如由于公差、不同注射量、不同直径或其他尺寸、不同柱塞形状、气泡或其他因素而导致没有两个筒将填充有完全相同量的物质，因此使人遗憾的是，在筒22已填充之后，柱塞24的位置不定。这可能造成一个问题，因为与柱塞24连接的齿轮和螺纹机构的总长度(其是预定的)可能不能满足柱塞24的填充位置(其是未知的)，从而造成不能适当地推动柱塞以给予物质的问题。
发明内容
本发明试图提供一种用于将药从筒中推出的改进的组件，其中该组件连接在致动器(例如电机)与推动装置(例如筒中的柱塞)之间，如下文中更详细地描述的。本发明解决了上述现有技术的问题。虽然参照PCT专利申请WO2009/044401对本发明进行了描述，然而应理解的是，本发明适用于许多类型的电机驱动的药筒。
因此根据本发明的一实施例提供了一种筒连接组件，包括：驱动柱塞，该驱动柱塞包括外轴；以及驱动器，该驱动器包括相对于外轴可伸缩地移动的内轴，其中驱动器的旋转导致驱动柱塞在远离驱动器的方向上前进，并且其中筒连接组件插入到一筒中，该筒中滑动地设置有柱塞，并且驱动器的旋转导致驱动柱塞在筒中朝着远端前进直至抵靠柱塞。驱动器可以包括齿轮。内轴可以与中间轴配合，并且中间轴可以与外轴配合，使得这些轴相对彼此可伸缩地移动。
根据本发明的一非限制性实施例，内轴螺纹通过螺纹接收在中间轴的中空部分内部，并且中间轴通过螺纹接收在外轴的中空部分内部。
根据本发明的一实施例还提供了一种用于连接在驱动器与滑动地设置在筒中的柱塞之间的方法，该方法包括将筒连接组件插入到筒中，该筒连接组件包括：驱动柱塞，该驱动柱塞包括外轴；以及驱动器，该驱动器包括相对于外轴可伸缩地移动的内轴，并且该方法包括使驱动器旋转以导致驱动柱塞在筒中朝着远端前进直至抵靠柱塞。
附图说明
从以下结合附图的详细描述，将更充分地理解和认识本发明，附图中：
图1是现有技术筒组件的简图；
图2是在筒已填充之前柱塞处于初始位置中的现有技术筒的简图；
图3是通过穿过隔膜插入到筒中的皮下注射器针头来填充现有技术筒的简图；
图4是通过穿过隔膜插入到药泵的壳体中的皮下注射器针头来填充现有技术筒的简图；
图5和图6分别是根据本发明的一实施例构造并操作的包括驱动柱塞的筒连接组件的简图和剖视简图；
图7和图8是根据本发明的一实施例的分别在驱动柱塞抵靠筒的柱塞之前和之后的插入到筒中的筒连接组件的简图；
图9和图10分别是根据本发明的另一实施例构造并操作的将旋拧到筒的柱塞中的驱动器(齿轮)离开并抵靠筒连接组件的本体的筒连接组件的简图；
图11A和图11B是根据本发明的一实施例构造并操作的示出了锁定组件的图9和图10的筒连接组件的特写图示。
具体实施方式
现在参照图5和图6，这两个图示出了根据本发明的一非限制性实施例构造并操作的筒连接组件80。
筒连接组件80包括位于外轴84的远端处的驱动柱塞82。驱动器86(诸如但不限于齿轮)包括内轴88。内轴88接收在中间轴90的中空部分内部并与中间轴螺纹配合。中间轴90又接收在外轴84的中空部分内部并与外轴螺纹配合。轴84，88和90布置为相对于彼此伸缩地移动。外轴84可还包括近端O型环92。驱动柱塞82和O型环92优选地由弹性体(诸如天然橡胶或合成橡胶)制成。其他部件可以由塑料或金属制成。
在一可替代实施例中，中间轴90可以省略，并且内轴88和外轴84可以布置为相对于彼此伸缩地移动。在另一可替代实施例中，可以具有布置为相对于彼此伸缩地移动的三个以上的轴。
现在参照图7，该图示出了插入到筒22中的筒连接组件80。驱动柱塞82最初略微远离筒22的柱塞24。驱动器86的(诸如通过与未示出的旋转电机配合)旋转导致内轴88旋转，这导致中间轴90旋转并朝着筒连接组件80的远端(即，在如用箭头91表示的朝着驱动柱塞82的方向上)线性地前进。中间轴90的远端移动又导致外轴84与驱动柱塞82一起朝着远端前进。驱动柱塞82抵靠筒22的内壁的摩擦使得对于驱动柱塞82而言与旋转相比更易于线性地移动，以使内轴88和中间轴90的旋转导致驱动柱塞82在筒22中朝着远端前进直至驱动柱塞82抵靠柱塞24，如图8所示。在可替代实施例中，当驱动柱塞82线性地前进直至其抵靠柱塞24时，允许驱动柱塞82略微旋转。在另一可替代实施例中，驱动柱塞82不需要接触筒22的内壁并在筒22中朝着远端前进直至抵靠柱塞24。
因此，通过本发明，无论在用待给予的物质填充筒22之后柱塞24的最终位置是怎样的，由于筒连接组件80的距离补偿作用，通过筒连接组件80用于推动柱塞24的驱动机构将总是适当地接触柱塞24。
现在参照图9和图10，这两个图示出了类似元件用类似标号表示的筒连接组件的可替代实施例。在该实施例中，筒连接组件100能通过螺纹连接而连接至柱塞124。柱塞124形成有螺纹孔126。筒连接组件100包括从其远端伸出、形成有与螺纹孔126对应的外螺纹的螺纹紧固件102。螺纹孔126和螺纹紧固件102形成有右旋(顺时针)螺纹。因此，伸缩轴形成有左旋(逆时针)螺纹，以与将螺纹紧固件102螺纹连接到螺纹孔126中的方向相反。筒连接组件100的伸缩轴(诸如第一实施例的伸缩轴84，88和90，在此未示出)在操作过程中顺时针(从驱动器86的远端观看)旋转，以朝着筒连接组件的远端线性地前进(如上所述)。
可能期望为筒连接组件100配备有完全位于组件100的本体103内部的伸缩轴，以使驱动器86(在图9和图10所示的实施例中用双齿轮示出，但本发明不限于这种齿轮)抵靠筒连接组件100的本体103的近端，如图10所示。如果伸缩轴没有在本体中紧贴地旋转至图10的位置，则这些轴在装配之前的运输和处理过程中可能旋开，因此没有保持图10的位置，这个位置是与筒柱塞装配的理想位置。另一方面，如果驱动器86过分紧靠组件100的本体以试图保持图10的关闭位置，这能够增加电机克服紧靠连接以开始使驱动器86旋转所需的力矩，从而使电机过载。
为了解决该双重问题(可能打开伸缩轴或驱动器过分紧靠)，锁定组件设置有如现在参照图11A和图11B描述的组件100。
驱动器86形成有由壁105和第一锁定齿106界定的凹部104。筒连接组件100的本体103的近端形成有第二锁定齿108。在图11A和图11B所示的最终位置(图10的最终位置)中，第二锁定齿108接收在凹部104中。第一和第二锁定齿106和108分别形成有倾斜壁110和112。倾斜壁110和112可在顺时针方向上滑过彼此，意味着第二锁定齿108在顺时针方向上在凹部104内外自由移动。这允许驱动器86在顺时针方向上的旋转，该顺时针方向是电机使驱动器86旋转以使伸缩轴朝着远端前进的方向。然而，第二锁定齿108不能通过壁105，这意味着第二锁定齿108不能在逆时针方向上通过凹部104，从而防止驱动器86远离本体103的近端而旋开。
因此，第一和第二锁定齿106和108的锁定组件使得容易装配伸缩轴组件与柱塞124，且达到并保持驱动器86的最终期望位置(即筒齿轮最终位置)。锁定组件防止伸缩轴组件在运输和处理过程中打开，并确保打开力矩在操作过程中较小。
本领域技术人员将理解，本发明不限于上文中已特别示出和描述的。相反地，本发明的范围包括上文中描述的特征的组合和子组合以及本领域的技术人员在阅读前述描述之后将做出的且不属于现有技术的修改和变型。

Claims (9)

1.一种筒和筒连接组件的组合，包括：
筒(22)，所述筒具有内圆柱表面、滑动地插入到所述筒(22)中的第一塞(24)、远端以及所述筒内的用于给予目标体的物质；
筒连接组件(80)，所述筒连接组件包括：
驱动柱塞(82)，所述驱动柱塞包括第一轴(84)；以及
驱动器(86)，所述驱动器包括第二轴(88)，所述第二轴(88)与所述第一轴(84)相配合，以使所述轴能相对于彼此伸缩地移动，其中，所述驱动器(86)的旋转导致所述驱动柱塞(82)在远离所述驱动器(86)的方向上线性地前进，该布置使得当将所述筒连接组件(80)插入到所述筒(22)中时，所述驱动柱塞(82)与所述内圆柱表面处于互补抗旋转摩擦关系中，所述互补抗旋转摩擦关系是阻止所述驱动柱塞(82)相对于所述筒(22)的旋转的力，以使所述驱动器(86)的旋转导致所述驱动柱塞(82)朝着所述远端线性地前进直至所述驱动柱塞(82)抵靠所述第一塞(24)，由此所述驱动柱塞(82)朝着所述远端推动所述第一塞(24)以定量供给来自所述筒的物质。
2.根据权利要求1所述的组合，其中，所述驱动器(86)包括齿轮。
3.根据权利要求1所述的组合，其中，所述第二轴(88)通过螺纹接收在所述第一轴(84)的中空部分内部。
4.根据权利要求1所述的组合，进一步包括通过螺纹接收在所述第一轴(84)的中空部分内部的中间轴(90)，所述第二轴(88)通过螺纹接收在所述中间轴(90)的中空部分内部。
5.根据权利要求1所述的组合，其中，所述驱动柱塞(82)位于所述第一轴(84)的远端处。
6.根据权利要求1所述的组合，包括从所述筒连接组件(100)的远端伸出的螺纹紧固件(102)，所述螺纹紧固件与形成在所述柱塞(124)中的螺纹孔(126)相配合。
7.根据权利要求1所述的组合，包括锁定组件，所述锁定组件允许所述驱动器(86)在第一旋转方向上旋转并阻止所述驱动器(86)在与所述第一旋转方向相反的第二旋转方向上的旋转。
8.根据权利要求7所述的组合，其中，所述驱动器(86)形成有由壁(105)和第一锁定齿(106)界定的凹部(104)，并且所述筒连接组件(80，100)的本体(103)的近端形成有第二锁定齿(108)，所述第二锁定齿在最终装配位置中接收在所述凹部(104)中，并且其中，所述第一锁定齿(106)和所述第二锁定齿(108)形成有能在所述第一旋转方向上滑过彼此的倾斜壁(110，112)，但是所述第二锁定齿(108)不能在所述第二旋转方向上移动通过所述壁(105)。
9.一种用于在驱动器与滑动地设置在筒中的柱塞之间进行连接的方法，所述方法包括：
提供筒(22)，所述筒具有内圆柱表面、滑动地插入到所述筒(22)中的第一塞(24)、远端以及所述筒中的用于给予目标体的物质；
将筒连接组件(80)插入到所述筒(22)中，所述筒连接组件(80)包括：驱动柱塞(82)，所述驱动柱塞包括第一轴(84)；以及驱动器(86)，所述驱动器包括第二轴(88)，所述第二轴(88)与所述第一轴(84)相配合，以使所述轴能相对于彼此伸缩地移动；以及
使所述驱动器(86)旋转以导致所述驱动柱塞(82)在所述筒(22)中朝着远端线性地前进直至所述驱动柱塞(82)抵靠所述第一塞(24)，该布置使得当将所述筒连接组件(80)插入到所述筒(22)中时，所述驱动柱塞(82)与所述内圆柱表面处于互补抗旋转摩擦关系中，所述互补抗旋转摩擦关系是阻止所述驱动柱塞(82)相对于所述筒(22)的旋转的力，以使所述驱动器(86)的旋转导致所述驱动柱塞(82)朝着所述远端线性地前进直至所述驱动柱塞(82)抵靠所述第一塞(24)，由此所述驱动柱塞(82)朝着所述远端推动所述第一塞(24)以定量供给来自所述筒的物质。
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US9259532B2 (en) 2016-02-16
WO2011090956A3 (en) 2011-11-24
BR112012017839B1 (pt) 2020-04-07
US20130190691A1 (en) 2013-07-25
EP2774637B1 (en) 2017-04-05
BR112012017839A2 (pt) 2016-04-19
US20110178463A1 (en) 2011-07-21
CN104069563A (zh) 2014-10-01
CN102883761A (zh) 2013-01-16
US20160030665A1 (en) 2016-02-04
CN104069563B (zh) 2016-12-07
EP2525846B1 (en) 2015-07-29
WO2011090956A2 (en) 2011-07-28
US7967795B1 (en) 2011-06-28
BR122019022494B1 (pt) 2020-10-27
EP2774637A1 (en) 2014-09-10
JP2013517095A (ja) 2013-05-16
JP5856077B2 (ja) 2016-02-09

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