CN101072597A - 插入器 - Google Patents
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- CN101072597A CN101072597A CNA2005800422356A CN200580042235A CN101072597A CN 101072597 A CN101072597 A CN 101072597A CN A2005800422356 A CNA2005800422356 A CN A2005800422356A CN 200580042235 A CN200580042235 A CN 200580042235A CN 101072597 A CN101072597 A CN 101072597A
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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
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
-
- 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
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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
-
- 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
- A61M5/14—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
- A61M2005/1587—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body suitable for being connected to an infusion line after insertion into a patient
Abstract
本发明涉及用于输注组件的插入器,该输注组件用于间断或连续地供给治疗物质,例如胰岛素。插入器包括:针体单元,该针体单元包括针体承座(2)和载运本体(4);以及套管壳体(3)。该套管壳体和针体承座可释放地连接,且当它们连接时,插入针体(6)置于套管(5)内部。载运本体引导在退回位置和前进位置之间的、相对于组件壳体的运动。当释放时,针体单元和套管壳体通过弹簧单元(13)而压向前进位置,在该前进位置,针体和套管将布置在皮下。本发明的目的是提供用于输注组件的一次性插入器,该插入器能够使用户在使用过程中容易和安全地处理,并在使用后容易和安全地进行处置。
Description
技术领域
[01]本发明涉及用于输注组件的插入器,该输注组件用于间断或连续地供给治疗物质,例如胰岛素。插入器包括:针体单元,该针体单元包括插入针体;以及套管壳体,该套管壳体包括软的塑料套管,以便布置在病人皮下。
背景技术
[02]EP 688232 B1涉及低型面倾斜输注组件,它包括套管壳体,该套管壳体有软的塑料套管,以便布置在病人体内。在插入过程中,套管壳体锁定在针体承座上,且插入组件用手布置,即该组件不包括插入器。
[03]US 2002/0077599 A1涉及用于低型面倾斜输注组件的插入器,该插入器包括:插入器壳体,该插入器壳体有底壁;保持器,该保持器可滑动地与插入器壳体连接,用于沿基本与底壁平行的方向在退回位置和伸出位置之间运动。插入器还包括基座部件,该基座部件与插入器壳体的外表面连接。保持器用于可释放地接收套管壳体。当使用时,保持器30向前运动,使得针体27和套管26以合适角度刺入皮肤,并进入皮下层合适距离。然后,套管壳体28能够通过按压释放按钮66而从插入器组装体10中释放。然后,安装垫80固定在皮肤上,并取出针体27,从而留下就位的套管26。
[04]该参考文献涉及相当复杂的结构,且该复杂结构需要使用两个壳体部分,上部部分和底部部分可以由任意合适材料构成,并可以通过螺钉(23,图5)、互锁凸片、粘接剂、热铆接或它们的组合来保持,或者通过任何其它已知的固定装置。
[05]在US 6293925 B1中所述的插入器包括注射器和插入组件。注射器设计成使针体以选定插入角度以及在控制的插入力和插入速度的情况下穿过皮肤。注射器包括弹簧负载柱塞,该柱塞有头部,用于在使插入组件向外凸出的情况下接收和支承插入组件就位,用于经皮地穿过病人皮肤布置。柱塞设计成退回和保持在锁定位置,并有驱动弹簧,该驱动弹簧压缩成向柱塞头部施加预定弹簧力。图30和31示出当准备使用注射器时怎样使皮下插入组件14与注射器装配。
发明内容
[06]本发明的目的是提供简单便宜的、用于输注组件的插入器,该插入器能够在使用过程中由用户容易和安全地进行操作,且在使用后能够容易和安全地进行处置。
[07]本发明涉及用于倾斜输注组件的、一次性和低型面的插入器,该插入器包括组件壳体、套管壳体、针体承座、弹簧单元和载运本体,其中:
[08]组件壳体配设有在内表面上的引导装置,用于保证载运本体的运动;
[09]套管壳体包括要被布置在皮下的软套管;
[10]针体承座包括用于穿刺皮肤的针体;
[11]套管壳体和针体承座可释放地相互固定,且当相互固定时,针体联接套管;优选是,针体布置在套管内部;
[12]载运本体配设有在外表面上的引导装置,该引导装置保证相对于组件壳体(1)从退回位置至前进位置的运动;
[13]载运本体与释放装置连接,且当操作释放装置时,载运本体、套管壳体和针体承座通过弹簧单元而压向前进位置,当用户使装置抵靠皮肤时,在该前进位置,针体和套管将布置于皮下;
[14]针体承座和载运本体配设有不可释放的相互作用锁定装置。
[15]“联接”的意思是针体布置成充分靠近套管,以便保证套管的皮下插入,而不管针体布置在套管的内部、旁边或周围。
[16]根据本发明的一个实施例,针体承座和载运本体形成为单个单元,例如通过将组件壳体的活动部件和针体承座模制在一起,或者通过将插入针体直接固定在组件壳体的活动部件上。根据本发明,在插入器的制造过程中,在包括载运本体和针体承座的针体单元固定在组件壳体中之后,还可以使用自身已知的输注组件(例如由EP 688232 B1已知的组件)来形成在载运本体和针体承座之间的不可释放连接。不可释放的连接例如可以通过胶接、焊接或通过将两个单元相互机械锁定而形成。
[17]在优选实施例中,通过在针体承座的、由组件壳体的坚固部件覆盖的部分中形成开口以及通过在载运本体中形成相应凸起而在载运本体和针体承座之间形成不可释放的连接。当组件壳体布置在针体单元周围(“周围”的意思是组件壳体在至少两个相对侧覆盖针体单元)时,组件壳体的弹性将两个相对侧挤压在一起,从而将针体承座和载运本体挤压在一起,或者通过基本刚性的组件壳体的两个相对侧产生的限定空间将载运本体的凸起和针体承座的开口压在一起,并当针体承座的开口和载运本体的凸起完全装配在一起时在载运本体和针体承座之间形成不可释放的连接。
[18]根据本发明的另一实施例,针体单元在使用后锁定在插入器上。当针体单元在使用后锁定在插入器上时,用户可以通过仅抓住插入器而除去插入器和针体单元,而不是用户在使用后抓住插入器和针体单元。根据图1-3所示的实施例,针体单元锁定在插入器上,因为针体单元只能够在有限空间内运动。该有限空间通过在三侧的U形组件壳体、通过在两侧的组件壳体的引导装置和针体单元(因为引导装置防止侧向运动)以及通过止动器12来限定,该止动器12防止针体单元超过固定点向前运动。
[19]根据本发明的另一实施例,可以使针体单元从前进位置(在该前进位置,针体能够穿刺病人皮肤)返回至退回位置,以便降低与使用过的针体接触的危险。
[20]根据本发明的另一实施例,组件壳体的底部部分(该组件壳体的底部部分是在插入过程中最靠近用户的一侧)可以拉伸,并相对于基线(该基线是平行于针体但是高度更低的线,其中,“高度更低”的意思是更靠近用户,即组件壳体的更低侧的高度)向前弯转。底部部分的该延伸或凸出提供了在病人皮肤和插入器之间的合适接触,以便使套管以合适角度插入,且延伸或凸出部件使安装垫升高至用于与皮肤接触的合适位置。
[21]当针体单元处于退回位置时,凸出部件的端部优选是将超过由插入针体的端部之前的针体/套管而形成的线。这使得需要在延伸部分中提供开口,以便使针体/套管能够通过。根据图1-3的实施例,这通过将该凸出部件分成两个支脚来实现。在本实施例中,凸出部件形成为数学上连续的曲线,但是它也可以是不连续的,即配设有一个或多个断开处。
[22]在本发明的另一方面,组件壳体由单件材料制成。针体承座壳体由单件材料构成意味着不需要螺钉等来装配或固定包围载运本体和插入器组件的外壳。组件壳体可以通过模制(即注射模制)来制造,或者通过任意其它已知的技术。还有,组件壳体可以制造为例如两半,然后,这两半胶接或焊接在一起。组件壳体可以由塑料或金属或具有所需机械特性的任意其它合适材料来制造。
[23]本发明的插入器为简单结构,并包括相对较少的部件,因此制造和装配将更便宜。这使得该插入器特别适合用作一次性产品。
[24]在还一实施例中,组件壳体由单件U形材料而形成。组件壳体为U形,这意味着它由矩形或椭圆形扁平材料构成,该扁平材料进行弯曲,这样,当从侧部看,该材料的端部形成两个基本平行的支脚,这两个支脚在一端通过直线或弧形线而连接,其中,支脚并不需要有相同长度。材料为弯曲形状并不意味着它通过弯曲而构成;它例如可以模制成弯曲形状。当组件壳体为U形时,称为低位支脚的部件是当插入器处在用于插入注入装置的位置时与用户接触的支脚。
[25]在另一实施例中,组件壳体形成为具有圆形或多边形切开型面的管件。
[26]在还一实施例中,弹簧单元在第一位置处固定在组件壳体上,且在第二位置处固定在载运本体或针体单元上,其中,当弹簧单元被偏压(biased)时,第一位置布置成比第二位置更靠近组件壳体的前端,其中,组件壳体的前端是在插入过程中最靠近用户的组件壳体端部。当释放装置驱动时,该特征将使得形成单个单元的载运本体和针体承座相对于壳体向前拉动。弹簧单元可以由将退回至一松弛的未被偏压(unbiased)的位置的任意材料来制成,优选是由橡胶、塑料或金属来制造。
附图说明
[27]下面将参考附图更详细地介绍本发明,附图中示出本发明的优选实施例。
[28]图1是一本发明的插入器的实施例的上部/侧部视图,其中输注组件处于退回位置;
[29]图2是一插入器的上部/侧部视图,其中,输注组件处于前进位置;
[30]图3是一插入器的上部/侧部视图,其中,输注组件处于前进位置,套管壳体与针体单元分开;
[31]图4是一连接在套管壳体上的针体单元的上部/侧部视图;
[32]图5是一具有输注组件的插入器的另一实施例的底部/侧部分解图;
[33]图6是一图5所示的、具有输注组件的插入器的上部/侧部分解图;
[34]图7是一图5所示的插入器的上部/侧部视图,其中,针体单元与套管壳体分开,且处于前进位置;
[35]图8是一插入器的第三实施例的上部/侧部视图,该插入器布置成准备用于输送;
[36]图9a和b示出第三实施例的一分解图;
[37]图10示出第三实施例的载运本体,该载运本体处于准备用于插入的退回位置;
[38]图11示出一具有C形弹簧单元的第四实施例的侧视图;
[39]图12示出第四实施例的、组合有弹簧单元的针体单元从上部/后部看的视图;
[40]图12A示出一类似于第四实施例的弹簧单元从上部/前部看的视图;
[41]图13示出一具有圆形弹簧的第五实施例从侧部A、从上部B和从后面C看的视图;
[42]图13A示出一具有圆形弹簧的第二实施例从侧部看的视图;
[43]图14示出一具有S形弹簧单元的第六实施例从上面看的视图;
[44]图15示出一具有线圈弹簧单元的第七实施例从侧部看在(A)前进位置和(B)退回位置的视图;
[45]图16示出一具有片簧的第八实施例,其中视图A:从侧部看的前进位置,视图B:从后部看的前进位置,视图C:从侧部看的退回位置,视图D:从上部看的退回位置;
[46]图17示出一具有固定在组件壳体相对侧上的弹簧单元的第九实施例,其中视图(A)从侧部看的前进位置,视图(B)从侧部看的退回位置,视图(C)从上部看的前进位置,视图(D)从上部看的退回位置的视图;
[47]图18示出一具有螺旋弹簧单元的插入器的第十实施例;
[48]图19示出S形弹簧单元的第十一实施例的一侧视图;
[49]图20示出S形弹簧单元的第十一实施例从上部看的一视图;
[50]图21示出一能够通过本发明的插入器来插入的输注组件。
具体实施方式
[51]图1-3的插入器组件包括:组件壳体1;针体单元,在本实施例中,该针体单元由一包括插入针体6的针体承座2和一与该针体承座2可释放地连接的载运本体4构成;以及套管壳体3,该套管壳体3包括侧向(laterally)凸出的套管5。
[52]组件壳体1配设有释放按钮7,当释放按钮被驱动时,该按钮将释放弹簧单元13,并使得针体单元2、4和套管壳体3向前运动至前进位置。当释放按钮7驱动时,针体单元的柔性部件8将向下推动,并从未示出的止动件中释放。柔性部件8在图2、3和7中表示为针体单元处于前进位置,而在图4中表示为针体单元与组件壳体1隔开。
[53]图1-3和5-7示出本发明实施例,其中,组件壳体1为U形形状并有上部支脚1a和低位支脚1b。在该实施例中,上部和低位支脚平行,并在一端通过长度与针体单元2、4的高度大约相同的材料件而连接。在上部和低位支脚1a、1b之间的距离取决于与套管壳体3连接的针体单元2、4的高度和总体形状,且在上部和低位支脚1a、1b之间的距离应当足以包含引导装置9a、9b、9c,当针体单元2、4和套管壳体3在退回位置和前进位置之间运行时,该引导装置使它们保持就位。
[54]图1-3中的组件壳体的引导装置包括:两个相对和向外L形部件9a,它们由低位支脚1b支承;凸缘9b,该凸缘9b从上部支脚1a向下伸出;以及凸缘9c,该凸缘9c从上部支脚1a的侧部向内伸出,并与针体单元2、4的侧部9e接触。在针体单元2、4上的相应引导装置包括在针体单元2、4底侧的两个向内L形部件(图中未示出),这两个部件的型面与在组件壳体1上的向外L形部件相对应,如图5所示,且在针体单元2、4上侧,两个凸缘9d从顶侧支持,保持与上部支脚1a和凸缘9b接触。
[55]在低位支脚1b的端部形成两个向外的弯曲部件10。这些部件10表示当用户插入套管时该用户的正确插入角度。而且,部件10还保证当插入套管5时,布置成与套管壳体3连接的安装垫14将处于正确的待用位置。
[56]从低位支脚1b伸出的基本三角形部件11用于方便操作,因为总的插入器组件相当小,且当用户的灵活性降低时可能很难操作。
[57]图6和7中示出弹簧单元13,当释放按钮7驱动时,该弹簧单元13向前推动针体单元2、4。弹簧单元13布置在组件壳体1和针体单元2、4之间并在U形组件壳体1的封闭端。弹簧单元13固定在针体承座2的后端处凸起18a上和固定在组件壳体1内部的凸起18b上。弹簧单元13可以为任意合适弹簧,但是在本实施例中,弹簧单元13优选是线圈弹簧,它将针体单元2、4推离组件壳体端部。
[58]弹簧单元13还可以是片簧,它布置在组件壳体1和针体单元2、4之间并在U形组件壳体1的封闭端,或者弹簧单元13可以形成在组件壳体1的前部和针体单元2、4的后部之间的弹性连接,从而向前拉动针体单元2、4。
[59]为了在使用释放按钮7时控制针体单元2、4的向前运动,组件壳体1的低位支脚1b配设有止动器12。在图1-3的实施例中,当针体单元2、4上的相应凸起撞击止动器12时,针体单元2、4停止向前运动。在图5-7的实施例中,两个凸缘9f在轨道19中运动,该轨道19形成为低位支脚1b中的槽,且当凸缘9f与轨道19的一端或两端接触时提供止动器12a。
[60]当没有止动器12来停止针体单元2、4的向前运动时,针体单元2、4将在针体单元的前部与用户皮肤接触时停止。使用止动器12将更容易控制插入深度,且止动器12能够将针体单元2、4锁定在组件壳体1上,从而能够在使用后将插入器和针体单元2、4作为单件而取出。
[61]在另一优选实施例中,止动器12由U形组件壳体1的上部和低位支脚1a和1b的端部形成。当支脚1a和1b的一端或两端向内弯曲时,该支脚端部限制在U形组件壳体的开口端处在上部和低位支脚1a、1b之间的距离。当该距离限制为小于针体单元2、4的高度时,向内弯转的端部用作止动器12。
[62]在图5中,针体承座2表示为与套管壳体3和载运本体4分开。在该优选实施例中,针体承座2包括在后半部分中的两个开口15,该开口15与在载运本体4上的两个凸起16相对应。当凸起16布置在开口15中时,针体承座2和载运本体4在水平平面中彼此相对锁定(在本实施例中,水平平面是垂直于在针体承座2的开口和载运本体4的凸起之间的接触表面的平面)。当包括连接的针体承座2和载运本体4的针体单元2、4布置在组件壳体1中时,组件壳体1的支脚1a和1b覆盖在两相对侧的针体单元2、4,并防止沿垂直方向运动。
[63]当插入器组件进行制造并准备使用时,它通常以包装、成套和消毒的状态而交付给用户,以便准备使用。当用户打开包装时,针体单元2、4与形成输注组件的套管壳体3连接,且输注组件处于退回位置。安装垫14布置在套管壳体3的底侧,且安装垫的粘性侧由隔离纸覆盖。用户从安装垫上除去隔离纸,并将插入器的底部部件1b、10布置成以合适角度抵靠在皮肤上;然后用户拖动释放按钮7。
[64]当推动释放按钮7时,针体单元2、4与套管壳体3一起释放,并向前推向前进位置,并且当布置在套管5内部的插入针体6刺入皮肤时,套管将布置在皮下。
[65]套管例如可以为EP专利No.688232中所述的已知类型,其中,套管5布置在穿过套管壳体3的矩形孔中。除了该通孔,该文献的套管壳体包括两个引导开口和两个锁定开口。这些开口为关于包括穿过通道的中心轴线并垂直于后侧延伸的平面对称的形状。引导开口为基本方形截面的细长开口,该开口用于接收在连接针体或连接承座上的引导销17。在图3、5、6和7中,针体单元2、4与套管壳体3分开,可以看见针体承座2的引导销17。
[66]当由安装垫14覆盖的套管5和套管壳体3布置就位时,用户从针体单元2、4上松开套管壳体3,并除去插入器组件的剩余部分(包括组件壳体1和锁定在组件壳体1上的针体单元)。在EP专利No.688232中,示出在套管壳体和针体承座之间的合适的可释放连接,且该实例被本文参引。
[67]为了以可靠方式来处置使用过的插入器剩余部分,用户能够将针体单元2、4拉回至退回位置,并将插入器剩余部分放回至打开的包装中。
[68]在已经处置了插入器和针体单元之后,用户能够使套管壳体3(这时固定在用户皮肤上)与连接承座连接。
[69]连接承座可以通过软管而与鲁尔(luer)连接部件连接。通过鲁尔连接部件,能够从泵供给合适的治疗物质,例如胰岛素。连接承座还可以是具有合适进口的关闭部件,该进口用于注射器的插入针体。该关闭部件可以保持该位置直到三天,同时用户能够通过该进口注入药物例如胰岛素,以便减少皮肤的外伤。
[70]图8-10所示的第三实施例的插入器组件包括:组件壳体1;针体单元,该针体单元由包括插入针体6的针体承座2和与该针体承座2可释放地连接的载运本体4而构成;以及套管壳体3,该套管壳体3包括套管5。
[71]在图8中示出本实施例怎样进行输送:针体单元2、4放松,即无偏压(non-biased)或只是稍微向前偏压的位置,且针体由硬的外壳顶部20而覆盖,该外壳顶部20必须在使用前从装置上除去。组件壳体1形成为具有椭圆形切开型面的管件。组件壳体1在对着硬外壳顶部20的位置处覆盖有可拆卸的扁平盖21。该扁平盖能够配设有粘接剂,用于保证在盖21和组件壳体1之间的气密密封,或者它能够被焊接在组件壳体上,同时具有承受运输所需的强度和能够提供装置的气密密封的任意盖都可以使用。针体单元2、4与手柄22可释放地连接,该手柄在底端配设有凸起23,用于固定弹簧单元13(见图9a和9b)。载运本体4的上侧配设有成矩形板形状的引导装置9d,载运本体4的该引导装置9d装配至组件壳体1的、具有向下L型形状的引导装置9b中。
[72]L型面和矩形板的组合保证载运本体具有有限的上下运动能力,并以很好控制的方式沿组件壳体1的臂引导。在本实施例中,弹簧单元13包括成O形环形状的弹性体。弹簧在位置p1处固定在组件壳体1的底侧前部部分上,并在位置p2处固定在载运本体4的后部部分上。在本实施例中,弹簧单元13固定在载运本体4的载运部分的后面(和远处),这使得当弹簧被偏压时载运本体4进入稍微倾斜的位置,因为只有载运本体4的底部由弹簧单元13向前拉动,且该倾斜位置能够锁定,或者使载运本体4锁定在退回位置,因为引导装置9d配设有在最后一半上的凸出部件30(见图12、15、19、20)。当弹簧单元13被偏压时,该凸出部件30受到向下力的影响,该向下力因为载运本体4在低点向前拉动而产生。
[73]当用户将使用该装置时,通过拉动手柄22直到(1)在手柄底侧的凸起23经过在组件壳体1底部内侧的凸出部件24或者直到(2)在引导装置9d上的凸出部件30经过在组件壳体1的L形引导装置9b的端部或开口,针体单元2、4进入退回位置(见图10)。然后,用户使向上弯曲的部件10抵靠在皮肤上,并释放针体单元2、4。
[74]当用户希望从退回位置释放针体单元2、4时,当针体单元通过(1)而锁定时,用户能够将两个压力点7推至一起,或者当针体单元通过(2)而锁定时,用户能够在7a处向下推。优选是,在组件壳体1的上侧和底侧都将有所示的压力点7a,以便使用户施加相对方向的手指力。当点7彼此相向推动时,壳体的、垂直于在压力点之间的线的直径将增大,且当在载运本体4上侧的引导装置9d卡入向内的L形部件中时,凸起23升高脱离凸出部件24。这驱动弹簧单元13,并使得针体单元2、4和安装的套管壳体3向前运动至前进位置。当在7a处向下推时,用户将引导装置9d的前端向下推动,并使得在引导装置9d后端的凸出部件与组件壳体1的装置9b脱开,这驱动弹簧单元13,并使得针体单元2、4和安装的套管壳体3向前运动至前进位置。
[75]在图11和12中示出具有不同种类的弹簧单元13的第四实施例。本实施例的弹簧单元13由两个片簧制成,且当弹簧单元未被偏压时,它们每一个都形成为C形。片簧形成为C形意味着它们只包括一个凸曲线,弹簧怎样形成和怎样固定在曲线的各端13a和13b上将取决于弹簧所选择的材料和形状。片簧13固定在组件壳体1的底壁上,这样,C形弹簧单元13的后端13a相对于组件壳体1静止。片簧的前端13b抵靠在针体单元2、4的表面4a上,或者固定在针体单元2、4上。在本实施例中,C形弹簧单元13布置在针体单元2、4的后端和组件壳体1的后端之间,且当手柄22拉回时,弹簧单元13被偏压,C形弹簧单元的两端13a和13b拉拢得更靠近。当释放按钮17驱动时,弹簧单元13将返回未被偏压形状,且针体单元2、4将向前推动。
[76]在图12A中示出片簧13固定在组件壳体1的顶壁上的实施例,这样,稍微C形的弹簧单元13的后端13a相对于组件壳体1静止。片簧的前端13b抵靠在针体单元2、4的表面上,或者固定在针体单元2、4上,但是在本实施例中,该前端13b低于针体高度地固定在针体单元2、4的前部部分上。
[77]片簧怎样在13a处固定在组件壳体1上将取决于它们的制造材料,因为这影响它们的制成形状,特别是厚度。当片簧由塑料材料制造时,当它们例如通过模制来制造时,在它们固定于壳体1上的位置处的材料几乎可以采取任意形状。当材料为合适厚度时,片簧的凸出部件25可以压入组件壳体1的开口中。当片簧由例如金属制造时,在片簧上形成凸出部件25将更昂贵,这时,在要固定在组件壳体1上的片簧中切割例如三侧边矩形狭槽并形成切口26就很充分了。该狭槽使得切口26能够从片簧表面上向外弯曲,并使它抵靠在组件壳体1上。当片簧通过凸出部件25或通过切口26而固定在组件壳体1上时,将不需要通过例如焊接、胶接等来将弹簧进一步固定在壳体上。
[78]图13示出插入器的第五实施例,其中,弹簧单元13由圆形弹簧形成。圆形弹簧13的最后侧部分13a相对于组件壳体1静止,且圆形弹簧13的前部部分13b固定在针体单元2、4上或固定在手柄22上,或者在稍微偏压的状态下简单地抵靠在活动针体单元2、4或手柄22上。弹簧单元可能形成有延伸部分13c,该延伸部分13c沿组件壳体1的底壁延伸。总之,这样的延伸部分13c能够沿其长度被固定,但是,优选地在接近组件壳体1的前部的一位置p1处固定。
[79]图13A示出一实施例,其中,圆形弹簧单元13的最后侧部分13a抵靠着组件壳体1的上部(针体高度之上),且圆形弹簧13的前部13b被固定到手柄22,其固定方式是:把一特定形成的部分按一轻度偏压的状态抵靠所述手柄22。
[80]图14示出第六实施例,其中,弹簧单元13形成为S形,并由金属或塑料制成的片簧而构成。当针体单元2、4处于它的最前侧位置时,S形弹簧的前部部分13b优选是以稍微偏压的状态固定或抵靠在针体单元的表面4a上;S形弹簧的最后端固定在组件壳体1的底部。优选是,最后端通过延长部件13c而固定在壳体上,该延长部分13c能够布置在由两个相对和向内弯转的竖立L形部件而形成的引杆(trail)中,并在后端例如通过使弹簧单元13的凸出部件25压入组件壳体1的开口中而固定,且在前端通过在延长部件中的三面矩形狭槽26而固定,该三面矩形狭槽26形成能够卡住组件壳体1的前边缘的切口。当手柄和针体单元拉回时,S形的两端压向一起,从而偏压弹簧,且当释放按钮驱动时,弹簧向前推动针体单元2、4。
[81]本发明第六实施例的弹簧单元13也可以形成为数字8,具有比普通S形更多的曲线,或者比数字8更圆。
[82]图15示出插入器的第七实施例,其中,弹簧单元13由线圈弹簧而形成。线圈弹簧单元13的最后侧部分13a相对于组件壳体1静止,且线圈弹簧13的前部部分13b固定在针体单元2、4上或固定在手柄22上,或者在稍微偏压的状态下简单地抵靠在活动针体单元或手柄上。弹簧单元13可以局部包围于沿组件壳体1的底壁布置的引杆中。该引杆优选是由与组件壳体1相同的材料制成。引杆可以包括从组件壳体1的底壁升高的壁,且该壁可以相互平行、向内圆角或彼此相向倾斜。针体单元2、4的一部分形成为向下延伸,且该部分向下延伸至引杆内部并在该引杆内部滑动。弹簧单元13的前端13b固定或抵靠在该部分上。当手柄22进入退回位置时,该部分通过将弹簧单元13的活动端13b推向静止端13a而保证引杆内部的弹簧单元13受到偏压。
[83]图16示出插入器的第八实施例,其中,弹簧单元13为圆形或矩形弹簧片。该弹簧片13的后端13a相对于组件壳体1静止,且该后端13b固定或抵靠在组件壳体1的顶壁的一部分上。前端13b例如在位置P2处(见图9a和9b)固定在针体单元2、4的底侧。
[84]图17示出插入器的第九实施例,其中,弹簧单元13固定在组件壳体1的相对壁上。在图17中,弹簧单元13的前端13b固定在组件壳体1的侧壁上,且弹簧单元13的最后侧部分13a在位置p3处固定或抵靠在活动针体单元2、4上。在该实施例中,弹簧单元13形成环绕针体单元2、4的底部部分的环路,且当弹簧单元处于未被偏压状态时实际并不接触位置p3。当手柄22拉回,从而使弹簧单元13受到偏压时,该环路将变形和环绕针体单元2、4的底部部分拉紧,且当释放按钮驱动时,针体单元2、4将通过弹簧单元13向前拉动,环路将返回到它的原始形状。优选地,本实施例将由金属丝或具有类似特征的其它材料来制造。
[85]还可以构成片簧的弹簧单元13,其中,最前侧部分抵靠在位置p3上,并在图C和D中以细黑线表示,且最后侧部分在侧壁的后部位置处固定在组件壳体1的侧壁上。这时,片簧将由金属或塑料制成。
[86]图18示出具有螺旋弹簧13的插入器,其中,弹簧的一端13a固定在针体单元2、4的底部部分上,且另一端13b固定在组件壳体1的前部的挂钩或类似物上。当针体单元2、4退回时,螺旋弹簧展开,且当释放保持器时,弹簧线圈向上和向前运动,使得针体和套管以合适角度刺入皮肤和进入皮下层合适距离。
[87]通过使弹簧金属丝的两端穿过弹簧线圈的中心通向弹簧的相对端,拉簧可以制成压缩弹簧。当拉动金属丝端部时,弹簧将压缩。
[88]图19和20示出第十一实施例,其中,弹簧单元13由两个片簧制成,且各片簧形成为稍微弯曲S形。片簧形成为S形意味着它们包括两个凸曲线。片簧13固定在组件壳体1的顶壁上,这样,S形弹簧单元13的后端13a相对于组件壳体1静止。片簧的前端13b固定在针体单元2、4上。在本实施例中,S形弹簧单元13布置在针体单元2、4的前端和组件壳体1的后端之间,且当手柄22拉回时,弹簧单元13被偏压,且S形弹簧单元的两端13a和13b靠拢得更接近。当释放按钮17驱动时,弹簧单元13将返回未被偏压形状,且针体单元2、4将向前推动。
[89]图21示出输注组件,它能够通过本发明的插入器而插入。输注组件包括:注入部件,该注入部件将通过插入器而插入;以及连接器部件,该连接器部件在插入后能够形成在例如胰岛素泵和注入部件之间的连接件。在本实施例中,连接器部件关于由两个臂形成的平面对称。
[90]这里所示的大部分弹簧单元实施例是压缩弹簧,除了第三实施例和第十实施例,该第三实施例提供了由弹性O形环构成的弹簧单元,而该第十实施例配设有由平螺旋弹簧构成的弹簧单元,这些单元是拉伸弹簧。第九实施例由圆角螺纹(round thread)构成,该圆角螺纹用作压缩和拉伸弹簧。
[91]弹簧单元例如可以由钢和塑料制成。塑料的弹簧单元优选是由POM(聚甲醛)制成,且组件壳体、硬外壳顶部和载运本体优选是由PP(聚丙烯)制成。当弹簧单元和载运本体模制在一起作为一个单元时,优选材料是POM。
[92]在本说明书中,术语“片簧”包括“弹簧片”。
[93]也可以使用磁体,而不使用弹簧单元13来使针体单元2、4从退回位置至前进位置。当使用磁体时,应当选择具有足够排斥力的排斥磁体来使得针体单元2、4从退回位置运动至前进位置。一个磁体布置在组件壳体1中,且另一磁体布置在承载注入装置的针体单元2、4处。当通过驱动释放按钮来释放针体单元2、4时,在磁体之间的排斥力将迫使针体单元2、4进入前进位置。磁体可以分别模制在组件壳体中和针体单元中,以便保护和隐藏磁体。而且,排斥磁体应当制成不同尺寸,以避免磁场变化。
[94]图21示出包括连接器部件40和套管壳体3的输注组件。套管壳体3能够通过权利要求所述的插入器而插入。在插入后,插入器的插入针体6与插入器一起除去,且连接器部件40布置在所示位置。在本实施例中,连接器部件40关于与针体平行并包括连接器部件40的两个臂41的平面对称。该连接器部件41还包括连接器针体42,该连接器针体穿透套管壳体3的屏障层。
[95]连接器部件40可以通过未示出的管而与鲁尔连接部件连接。通过鲁尔连接件,可以从泵供给合适的治疗物质,例如胰岛素。连接器部件还可以是具有合适进口的关闭部件,该进口用于注射器的插入针体。该关闭部件可以保留在该位置直到三天,同时用户可以通过该进口注入药物例如胰岛素,以便减少由于重复穿刺皮肤而引起的皮肤损伤。
Claims (21)
1.用于输注组件的插入器,其包括一组件壳体(1)、一套管壳体(3)、一针体承座(2)、一弹簧单元(13)和一载运本体(4),其中:
所述组件壳体(1)配设有在内表面上的引导装置(9a、9b、9c),用于引导所述载运本体(4)的运动;
所述套管壳体(3)包括要被皮下布置的的软套管(5);
所述针体承座(2)包括一用于穿刺皮肤的插入针体(6);
所述套管壳体(3)和所述针体承座(2)可释放地相互连接,且当它们进行连接时,所述插入针体(6)联接联接所述套管(5);
所述载运本体(4)配设有在外表面上的引导装置(9e、9d、9f),该引导装置在退回位置和前进位置之间引导相对于所述组件壳体(1)的运动;
且所述弹簧单元(13)与所述释放装置(7)连接,且当所述释放装置(7)被激发时,所述套管壳体(3)、所述针体承座(2)和所述载运本体(4)由所述弹簧单元促动至一前进位置,在该前进位置,所述针体(6)和所述套管(5)能够被布置于皮下;
其中,所述针体承座(2)和所述载运本体(4)配设有不可释放的相互作用锁定装置。
2.根据权利要求1所述的插入器,其特征在于:所述插入针体(6)布置在所述套管(5)内部。
3.根据权利要求1或2所述的插入器,其特征在于:所述针体承座(2)和所述载运本体(4)形成为一单个单元。
4.根据权利要求1或2所述的插入器,其特征在于:所述针体承座(2)包括在所述针体承座(2)的一部分中的开口(15),该开口由所述组件壳体(1)的材料覆盖,且所述载运本体(4)配设有与在所述针体承座(2)中的开口(15)相对应的凸起(16)。
5.根据权利要求1至4所述的插入器,其特征在于:所述针体单元(2、4)包括所述针体承座(2),且所述载运本体(4)在插入后能够被安置于退回位置中。
6.根据权利要求1至5所述的插入器,其特征在于:所述组件壳体(1)的底座形成有一凸出部件(10)。
7.根据权利要求6所述的插入器,其特征在于:所述凸出部件(10)与所述插入针体(6)的纵向方向成一角度。
8.根据权利要求1至7所述的插入器,其特征在于:它包括一止动器(12、12a)。
9.根据权利要求8所述的插入器,其特征在于:所述止动器(12a)包括用于一凸缘(9f)的一轨道(19)的至少一端。
10.用于一输注组件的插入器,其包括一组件壳体(1)、一套管壳体(3)、一针体承座(2)、一弹簧单元(13)和一载运本体(4),其中:
所述组件壳体(1)配设有在内表面上的引导装置(9a、9b、9c),用于引导所述载运本体(4)的运动;
所述套管壳体(3)包括要被皮下布置的软套管(5);
所述针体承座(2)包括一用于穿刺皮肤的插入针体(6);
所述套管壳体(3)和所述针体承座(2)可释放地相互连接,且当它们连接时,所述插入针体(6)联接所述套管(5);
所述载运本体(4)配设有在外表面上的引导装置(9e、9d、9f),该引导装置在退回位置和前进位置之间引导相对于所述组件壳体(1)的运动;
且所述弹簧单元(13)与所述释放装置(7、7a)连接,且当所述释放装置(7、7a)被促动时,所述套管壳体(3)、所述针体承座(2)和所述载运本体(4)由所述弹簧单元促动至前进位置,在该前进位置,所述针体(6)和所述套管(5)能够被布置于皮下;
其特征在于,所述组件壳体(1)由一单个材料单元来制造。
11.根据权利要求10所述的插入器,其特征在于:所述插入针体(6)被布置在所述套管(5)内部。
12.根据权利要求10至11所述的插入器,其特征在于:所述组件壳体(1)为U形。
13.根据权利要求12所述的插入器,其特征在于:所述U形的低位支脚包括一凸出部件(10),该凸出部件与一基线形成一定角度,该基线在所述针体(6)下面并与所述针体(6)平行。
14.根据权利要求10和11所述的插入器,其特征在于:所述组件壳体形成为一具有一圆形或多边形型面的管件。
15.根据权利要求1或10所述的插入器,其特征在于:所述组件壳体(1)形成用于所述插入器的输送包装的至少一部分。
16.根据权利要求1或10所述的插入器,其特征在于:所述组件壳体(1)配设有一硬顶部(20)。
17.根据权利要求1或10所述的插入器,其特征在于:所述弹簧单元(13)在第一位置(p1)处固定在所述组件壳体(1)上,且在第二位置(p2)处固定在所述载运本体(4)或所述针体承座(2)上,且当所述弹簧单元(13)未被偏压时,所述第一位置位于比所述第二位置更靠近所述组件壳体(1)的前端。
18.根据权利要求1或10所述的插入器,其特征在于:所述弹簧单元(13)为弹性O形环。
19.根据权利要求1或10所述的插入器,其特征在于:所述弹簧单元(13)在第一位置处固定在所述组件壳体(1)上,且在第二位置处固定在所述载运本体(4)或所述针体承座(2)上,且当所述弹簧单元(13)未被偏压时,所述第一位置位于比所述第二位置更靠近所述组件壳体(1)的后端。
20.根据权利要求1或10所述的插入器,其特征在于:所述弹簧单元(13)是布置在所述组件壳体(1)的后端和所述针体单元(2、4)之间的片簧。
21.根据权利要求20所述的插入器,其特征在于:所述弹簧单元(13)具有两个凸曲线的形状,这两个凸曲线在所述针体单元(2、4)的各侧;并且在未偏压状态下,各曲线在一端(13b)处固定在所述针体单元(2、4)上,在另一端(13a)处固定在所述组件壳体(1)上,所述组件壳体在固定至所述针体单元(2、4)的位置的后面。
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US7850658B2 (en) | 2003-11-10 | 2010-12-14 | Smiths Medical Asd, Inc. | Subcutaneous infusion device and method including release feature for adhesive portion |
US7731691B2 (en) | 2003-11-10 | 2010-06-08 | Smiths Medical Asd, Inc. | Subcutaneous infusion device and device for insertion of a cannula of an infusion device and method |
US7309326B2 (en) | 2003-11-18 | 2007-12-18 | Icu Medical, Inc. | Infusion set |
DE602004026114D1 (de) | 2004-01-16 | 2010-04-29 | Top Kk | Verweilnadel |
US20050159709A1 (en) | 2004-01-20 | 2005-07-21 | Becton, Dickinson And Company | Safety shield system for a plastic syringe |
DK1727576T3 (da) | 2004-03-26 | 2009-07-06 | Unomedical As | Infusionssæt |
US20050277892A1 (en) | 2004-06-09 | 2005-12-15 | Feng-Chi Tsao | Leakproof needle cover structure improvement |
US7585287B2 (en) | 2004-06-16 | 2009-09-08 | Smiths Medical Md, Inc. | Device and method for insertion of a cannula of an infusion device |
DE202004011617U1 (de) * | 2004-07-23 | 2004-10-07 | Clinico Gmbh | Kupplungsvorrichtung zum Anschließen einer medizinischen Versorgungsleitung an einen Katheter |
-
2005
- 2005-12-09 AU AU2005313662A patent/AU2005313662B2/en active Active
- 2005-12-09 MX MX2007006840A patent/MX2007006840A/es active IP Right Grant
- 2005-12-09 EP EP05812876A patent/EP1824537A2/en not_active Ceased
- 2005-12-09 WO PCT/DK2005/050010 patent/WO2006061027A2/en active Application Filing
- 2005-12-09 CA CA002589693A patent/CA2589693A1/en not_active Abandoned
- 2005-12-09 US US11/721,263 patent/US7867200B2/en active Active
- 2005-12-09 JP JP2007544738A patent/JP4964141B2/ja active Active
- 2005-12-09 CN CN2005800422356A patent/CN101072597B/zh active Active
- 2005-12-09 US US11/298,259 patent/US7867199B2/en active Active
- 2005-12-09 KR KR1020077013624A patent/KR20070086306A/ko active IP Right Grant
-
2007
- 2007-05-31 IL IL183601A patent/IL183601A/en not_active IP Right Cessation
- 2007-06-15 NO NO20073064A patent/NO20073064L/no not_active Application Discontinuation
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102470211A (zh) * | 2009-07-30 | 2012-05-23 | 犹诺医药有限公司 | 具有水平移动部件的插入装置 |
CN102470211B (zh) * | 2009-07-30 | 2014-05-07 | 犹诺医药有限公司 | 具有水平移动部件的插入装置 |
CN103826676A (zh) * | 2011-09-30 | 2014-05-28 | 安尼马斯公司 | 用于医疗导管的插入装置 |
CN103826676B (zh) * | 2011-09-30 | 2017-05-24 | 安尼马斯公司 | 用于医疗导管的插入装置 |
Also Published As
Publication number | Publication date |
---|---|
EP1824537A2 (en) | 2007-08-29 |
US7867200B2 (en) | 2011-01-11 |
CA2589693A1 (en) | 2006-06-15 |
MX2007006840A (es) | 2007-08-14 |
AU2005313662B2 (en) | 2011-07-14 |
KR20070086306A (ko) | 2007-08-27 |
JP2008522680A (ja) | 2008-07-03 |
WO2006061027A3 (en) | 2006-09-28 |
JP4964141B2 (ja) | 2012-06-27 |
IL183601A (en) | 2012-06-28 |
IL183601A0 (en) | 2007-09-20 |
US20060161108A1 (en) | 2006-07-20 |
AU2005313662A1 (en) | 2006-06-15 |
WO2006061027A2 (en) | 2006-06-15 |
NO20073064L (no) | 2007-09-04 |
US7867199B2 (en) | 2011-01-11 |
CN101072597B (zh) | 2010-06-16 |
US20090306596A1 (en) | 2009-12-10 |
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