CN101808685A - 具有双稳平衡状态的插入器 - Google Patents

具有双稳平衡状态的插入器 Download PDF

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CN101808685A
CN101808685A CN200880022603A CN200880022603A CN101808685A CN 101808685 A CN101808685 A CN 101808685A CN 200880022603 A CN200880022603 A CN 200880022603A CN 200880022603 A CN200880022603 A CN 200880022603A CN 101808685 A CN101808685 A CN 101808685A
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inserter device
inserter
flexible member
syringe needle
housing
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S·吉尔恩
S·B·哈斯特德
B·B·哈格多恩
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Unomedical AS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • 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
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1581—Right-angle needle-type devices
    • 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
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585—Needle inserters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion

Abstract

本发明涉及一种用于输注套装的插入器，其用来间歇地或连续地施用诸如胰岛素的治疗药物。该插入器包括用于插入和缩回引入针头的装置。使用根据本发明的插入器装置，能够在皮下或经皮放置医用装置时引入插入针头。插入器装置包括壳体(1，2，12)，所述壳体在插入所述插入针头之前隐藏所述插入针头(7，17)，并且能在插入所述插入针头和放置所述医用装置之后隐藏所述插入针头(7，17)。所述插入针头(7，17)在插入期间相对于所述壳体(1，2，12)朝向患者的皮肤表面移动。所述插入器装置包括具有两个平衡状态的双稳弹性元件(1，11)。

Description

具有双稳平衡状态的插入器
技术领域
本发明涉及一种用于输注套装的插入器，该输注套装用来间歇地或连续地施用诸如胰岛素的治疗药物。该插入器包括用于插入和缩回引导针头的装置。
背景技术
构造用于输注套装的插入器是众所周知的，该插入器在插入前隐藏和保护插入针头，并且在穿透患者皮肤后缩回插入针头，之后隐藏和保护该插入针头。
EP 1.762.259中公开了这样的装置。根据该文献的插入器包括具有插入针头的针座以及确保插入针头自动插入和自动缩回的两个弹簧部件。尽管这种装置的设计是紧凑并且用户友好的，但该机构较为复杂并且设置有必须相对彼此移动的部件。
本发明在插入前和缩回后提供对插入针头的保护，同时该插入器装置结构非常简单，使其生产成本低廉而且可靠。
US 2004/0116865A1中公开了另一种装置。该文献涉及一种针头插入装置，其包括壳体，该壳体具有用于施加到目标对象皮肤上的安装表面，其中所述安装表面限定大致平面，并且该安装表面上形成有针头孔。针头包括用于穿透目标对象的皮肤的远侧尖端，尖端相对于大致平面设置在壳体内。围绕所述针头孔的安装表面能够在第一位置和第二位置之间移动，在第一位置上，针头的尖端设置在壳体内，在第二位置上，当与针头将要进行注射的部位相对应的皮肤部分被拉动靠着针头时，针头的尖端伸出穿过针头孔。根据这种装置，注射针头相对于壳体是静止的，双稳部件移动皮肤而不是移动注射针头。
发明内容
本发明涉及一种插入器装置，用于在皮下或经皮放置医用装置时引导穿透部件进入患者皮肤。该插入器设备包括壳体，所述壳体在所述插入之前隐藏所述插入针头，并且所述壳体还能在插入和放置所述医用装置之后隐藏所述插入针头，其中所述插入针头在插入期间相对于所述壳体朝向患者的皮肤表面移动。所述插入器装置包括具有两个平衡状态的双稳弹性元件。
弹性元件为由于某种变形-例如由于压缩或拉伸-而能够储存弹性势能的装置，需要力使弹性元件变形。平衡状态为这样的一个状态，其中弹性元件处于平衡并且不会引起移动，尽管弹性元件不会引起移动，但它可以具有相当大的弹性势能，如果弹性元件被推离平衡状态，该弹性势能就可以被释放；如果弹性元件是双稳的，它将具有两个这种平衡状态。如果具有两个平衡状态的弹性元件被阻止到达最接近的第一平衡状态，那么它会从试图到达这个平衡状态中转换为试图到达第二平衡状态。双稳弹性元件可以是单个未装载的材料件，其能够在两个平衡状态之间跳变，或者双稳弹性元件可以是单个装载的材料件，其由于载荷而到达能够在两个平衡状态之间跳变的状态。该双稳弹性元件也可以由几个单独的材料件构成，所述几个材料件一起形成单个装载的或未装载的双稳弹性元件。
弹性元件的一个例子是螺旋盘簧，其通常不能用于本发明，因为这种弹簧只有一个平衡状态，当弹簧变形时，其总是试图回到这个平衡状态，而不管这种变形是压缩还是拉伸弹簧。
根据一个实施例，所述第一平衡状态处于缩回位置，在所述缩回位置所述插入针头和/或插管受保护而不受周围环境影响，所述第二平衡状态处于向前位置，在所述向前位置所述插入针头和/或插管从所述壳体伸出。
根据一个实施例，所述弹性元件形成为所述插入器装置的壳体的外表面的一部分。
根据另一个实施例，所述双稳弹性元件由具有两个相对端部的柔性材料件构成，尽管所述两个相对端部能够枢转，所述两个相对端部相对于所述壳体保持静止在恒定的距离，所述距离小于所述弹性元件处于未装载状态的长度。
根据一个实施例，通过触发装置能够使所述弹性元件从一个位置到另一个位置。
因为所述插入器装置结构简单、成本低廉，所以所述插入器装置通常是一次性的，即所述插入器装置用于单次使用。
通常，待插入的装置为包括贯通开口和插管的输注部件，或者待插入的装置可以是传感器部件，所述传感器部件包括用于皮下或经皮定位的传感器。
通常，所述医用装置包括用于将所述医用装置紧固到患者皮肤上的粘性近侧表面。所述粘性近侧表面可由不可释放地紧固到医用装置本体上的单独安装垫的近侧表面构成。
根据一个实施例，所述医用装置设有硬的自穿透插管，根据另一个实施例，所述插入器装置设有穿透插入针头，所述医用装置设有软的插管。
附图说明
图1a、1b和1c示出了根据本发明的插入器的实施例，包括带有待插入医用装置的具有双稳特性的壳体；
图2a和2b示出了插入器的另一个实施例，包括带有待插入医用装置的具有双稳特性的壳体；
图3a、3b和3c示出了插入器的第三个实施例，包括由扁平弯曲材料形式的双稳弹性元件，图3d示出了该实施例端口装置的插管部分的放大示意图；
图4a和4b为第三个实施例的内部机构示意图。
具体实施方式
图1a、1b和1c的实施例包括弹性元件1，该弹性元件也形成插入器装置的壳体的一部分。弹性元件1通过连接件3连接到壳体部分2。弹性元件1设有针座4，插入针头7嵌入到该针座4中。图1b是图1a的实施例的截面图，该图示出了处于准备好插入的位置的固定至弹性元件1的端口装置。图1所示的端口装置包括设有贯通开口的本体5和不可释放地紧固到端口装置的本体5上并从本体5的近侧伸出的插管6，端口装置的近侧是指当装置安装到患者身上时面对患者皮肤的那一侧。根据这个实施例，端口装置仅仅通过插入针头7与端口装置的插管6之间的摩擦力固定到弹性元件1上，但是如果比如端口装置为设有诸如钢制的硬插管的类型，其不需要插入针头来切穿患者的皮肤，那么端口装置可以通过例如在弹性元件1的近侧表面上设置突起部分而固定到插入器装置上，该突起部分可以被挤压到端口装置的本体5上对应成形的孔中，并且由于端口装置的本体5的侧面和弹性元件1的突起部分侧面的至少一部分之间的摩擦力而保持就位。
弹性元件1由较薄的材料制成，这就是为什么可以在插入器装置的外表面看见针座4的位置的原因。表面上的突起表示针座4和端口装置所处的位置，因此该突起可以用作触发按钮。如果弹性元件由较厚的材料制成，那么插入器装置需要设置实体的触发按钮以指示施加压力的正确位置。
壳体部分2的近侧周边，即壳体部分2与患者皮肤接触的部分在使用过程中是静止的，即在使用过程中不移动。位于接触表面上方并且形成连接件3的一部分的壳体部分2可以弯曲远离插入器的中心，壳体部分2由连续的材料制成，其可以弯曲而不会断裂，即该材料不是脆性的而是柔性的。
当要使用插入器装置时，首先将其从无菌包装中取出。通过将端口装置固定到插入器装置的针座4上，图1a和1b所示插入器的实施例可以方便地运送。然后将该插入器装置放置到患者皮肤上合适的位置并使用两个手指将其保持在那个位置，如图1b(右边)所示。接着向下按压针座4，如图1b中箭头所示。当向下按压时，弹性元件1变形而使得角度α(图1c所示)从大约90°改变到大约180°，弹性元件被迫使离开第一平衡状态，而试图到达第二平衡状态。弹性元件1的变形就象是从第一状态跳变到第二状态，因此触发按钮上轻微的压力会引起快速的变形，从而导致插入针头7“射”入患者体内。在压力从触发按钮上移除后，弹性元件跳回到第一平衡状态，并且将插入针头7从患者和端口装置缩回。缩回是因为由于弹性元件在到达第二平衡状态前就碰到患者皮肤而绝不会到达第二平衡状态。因为弹性元件1只能在两个平衡状态下保持静止，所以弹性元件被称作双稳。
图2a和2b示出了根据本发明的插入器装置的另一个实施例。这个实施例也包括弹性元件1，该弹性元件1形成插入器装置的壳体的外表面的一部分。与图1a和图1b中相同的附图标记表示相同的部件。图2所示的端口装置包括本体5和插管，所述本体5设有贯通开口，当插入器装置安装到患者身上时，该插管还是不可释放地紧固到端口装置的本体5上并从本体5近侧延伸的穿透部件7。根据这个实施例，端口装置可以通过设置在针座4中的结构固定到弹性元件1上，例如针座4可以设置有一个或多个突起部件，该一个或多个突起部件配合到端口装置的本体5的远侧表面中紧密对应的开口中。
图2的实施例的触发和工作方式和图1的实施例所描述的相同。
图3a、3b和3c示出了根据本发明的插入器装置的第三个实施例。该实施例也包括双稳弹性元件11，该双稳弹性元件位于壳体12内。弹性元件11通过将其圆形端部置于壳体12的相对壁上的槽13中而保持就位。弹性元件的端部所处的壳体的壁之间的距离小于构成弹性元件11的柔性材料件的长度。针座14紧固到弹性元件11的中心部分，插入针头17嵌在针座14中，使得该插入针头不可释放地紧固到针座14上，例如在模制过程中嵌入该插入针头。该插入器装置设有触发按钮23，所述触发按钮23安装成使得触发按钮23的突起部分24与弹性元件11接触，尤其是在触发按钮23被触发时，也就是触发按钮23被迫使离开平衡状态时，突起部分24触碰弹性元件11。一对引导部件25紧固在壳体12上，以便控制弹性元件11从缩回位置到向前位置的移动。引导部件25在弹性元件11的两侧平行放置在竖直位置，并且覆盖弹性元件11移动路径的整个长度。
要利用这个实施例的插入器装置插入的装置是结合有单独的插管部分的端口装置。图3d示出了插管部分的放大示意图。端口装置包括由较硬的材料制成的本体15，插管部分包括由较硬的材料制成的本体20、防止微生物进入到内部开口的隔膜22以及由软且柔性的材料制成的插管16。插管部分还包括锁定部分21，该锁定部分21将插管部分固定在端口装置的本体15中的期望位置上。PCT/DK2006/000737中详细描述了插管部分和提出的锁定部分21的实施例，该申请的相关部分通过参考并入本文。本体15可以设有安装垫18，安装垫18不可释放地紧固到本体15上，或者安装垫18可以设成单独的衬垫并且安装垫18在插入器装置定位在插入位置之前附接到患者皮肤上。如果安装垫18不可释放地紧固到本体15上，那么应当在使用前移除保护粘性表面的层，然后将安装垫16的粘性表面和插入器装置一起置于患者皮肤上。
因为弹性元件11是弯曲的并且处于张力作用下，所以其仅仅具有两个静止的位置-即两个平衡状态-缩回位置和向前位置，在缩回位置插入针头和插管被保护而不受周围环境影响，在向前位置插入针头17和插管16被皮下放置或经皮放置。由于针座14和待插入的装置的本体15的体积不允许，双稳弹性元件11绝不会在向前位置到达完全静止位置，因此弹性元件11在已经于缩回位置被触发并且试图到达向前位置之后，将自动地跳回到缩回位置，并且由于插管部分的锁定部分21与端口装置的相应部分连接而将插管装置留在端口装置的本体15中，并防止插管部分与弹性元件11和针座14一起缩回。
当要使用插入器装置时，首先将其从无菌包装中取出。根据该实施例，端口装置可以和插入器装置一起被运送，其中所述端口装置位于插入器装置近端的成型孔中同时插管部分附接至插入针头，或者端口装置可以被单独运送并且在使用插入器装置之前通过安装垫18紧固到患者的皮肤上。在把端口装置和安装垫18一起放置在合适的位置并保持就位之前或之后，将插入器装置放置在患者皮肤上。然后朝向壳体12的中心推压触发按钮23。当触发该触发按钮23时，突起部分24推压弹性元件11离开第一静止位置，即缩回位置。当继续向前推压触发按钮23时，触发按钮在其位于弹性元件11上的固定点处折断。这个特征防止了插入器装置的反复触发，而插入器装置的反复触发可引起问题或不舒服，因为目前可能已经污染的插入针头17会跳出壳体并将周围环境暴露于皮肤穿透和可能的感染。

Claims (12)

1.一种插入器装置，用于在皮下放置或经皮放置医用装置时引入插入针头(7，17)，所述插入器装置包括壳体(1，2，12)，所述壳体在插入之前隐藏所述插入针头(7，17)，并且能在插入和放置所述医用装置之后隐藏所述插入针头(7，17)，所述插入针头(7，17)在插入期间相对于所述壳体(1，2，12)朝向患者的皮肤表面移动，其特征在于，所述插入器装置包括具有两个平衡状态的双稳弹性元件(1，11)。
2.如权利要求1所述的插入器装置，其特征在于，其中一个平衡状态处于缩回位置，在所述缩回位置所述插入针头(7，17)和/或插管(6，16)被保护而不受周围环境影响，其中第二平衡状态处于向前位置，在所述向前位置所述插入针头(7，17)和/或插管(6，16)从所述壳体(2，12)伸出。
3.如权利要求1或2所述的插入器装置，其特征在于，所述插入针头(7，17)固定到所述弹性元件(1，11)上。
4.如权利要求1、2或3所述的插入器装置，其特征在于，所述弹性元件(1)为所述插入器装置的壳体的外表面的一部分。
5.如权利要求1、2或3所述的插入器装置，其特征在于，所述弹性元件(1，11)由具有两个相对端部的柔性材料件构成，所述两个相对端部相对于所述壳体保持静止时的距离小于所述弹性元件处于拉伸或未装载状态时的长度。
6.如前面任何一项权利要求所述的插入器装置，其特征在于，所述弹性元件(1)能够通过触发装置(23)从一个位置到另一个位置。
7.如前面任何一项权利要求所述的插入器装置，其特征在于，所述插入器装置是一次性的，即所述插入器装置用于单次使用。
8.如前面任何一项权利要求所述的插入器装置，其特征在于，待插入的医用装置为包括贯通开口和插管的输注部件。
9.如权利要求1-7中任一项所述的插入器装置，其特征在于，待插入的装置为传感器部件，所述传感器部件包括用于皮下或经皮定位的传感器。
10.如前面任何一项权利要求所述的插入器装置，其特征在于，所述医用装置包括用于将所述医用装置紧固到患者皮肤上的粘性近侧表面。
11.如前面任何一项权利要求所述的插入器装置，其特征在于，所述医用装置设有硬的自穿透插管。
12.如权利要求1-10中任一项所述的插入器装置，其特征在于，所述插入器装置设有穿透插入针头(7，17)，所述医用装置设有软的插管(6，16)。
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IL202747A0 (en) 2010-06-30
US20100286615A1 (en) 2010-11-11
WO2009004026A1 (en) 2009-01-08
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RU2010103450A (ru) 2011-08-10

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