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CN102089021A - 用于经皮部件的插入器 - Google Patents

用于经皮部件的插入器 Download PDF

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CN102089021A
CN102089021A CN2009801265187A CN200980126518A CN102089021A CN 102089021 A CN102089021 A CN 102089021A CN 2009801265187 A CN2009801265187 A CN 2009801265187A CN 200980126518 A CN200980126518 A CN 200980126518A CN 102089021 A CN102089021 A CN 102089021A
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S·吉尔恩
O·马塞厄森
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Unomedical AS
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. 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
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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
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    • 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
    • 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
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • 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
    • A61M5/14—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0246—Holding devices, e.g. on the body fixed on the skin having a cover for covering the holding means
    • 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
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2209/00—Ancillary equipment
    • A61M2209/06—Packaging for specific medical equipment
    • 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

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Abstract

本申请涉及一种包括经皮部件和插入器的装置，其中该经皮部件具有安装表面。所述装置在输送过程中被置于无菌包装物之中，该包装物用作插入器，并被附接到所述经皮部件，即，所述包装物和所述插入器是一个一体单元。该装置包括经皮部件和插入器。所述经皮部件包括：具有安装表面(2)的安装部分(1)，硬质套管(9)，引导流体从流体源流向所述硬质套管(9)的流体路径；所述插入器包括：使用前至少部分地覆盖所述经皮部件的包装物(10)，该包装物(10)包括：在正常使用过程中不能由使用者变形的不可变形部分，以及在使用过程中可沿着插入方向被纵向地缩短的可变形部分(10a)。优选地，所述安装表面(2)至少部分具有粘性。

Description

用于经皮部件的插入器
技术领域
本发明涉及一种包括经皮部件和插入器的装置，其中经皮部件具有安装表面。该装置在输送过程中被置于无菌包装物中，该包装物用作插入器，并被附接到所述经皮部件，即，所述包装物和所述插入器是一个一体单元。
背景技术
WO2007/141210公开了一种组件，该组件包括可安装于皮肤的装置和用于该装置的包装物。所述装置的所述包装物可被附接到封闭的可安装于皮肤的装置，并且随后所述包装物可被用作施加器，用于将所述可安装于皮肤的装置安装于病人的皮肤表面上。当所述包装物被沿着壳体的方向，即沿着皮肤表面推动时，所述包装物将从所述可安装于皮肤的装置上卸下。本体部分包括壳体部分，在壳体部分中安置有套管插入机构，即，所述套管插入机构不是所述包装物的组成部分，按照该文献所述套管插入机构是复杂的，其包括盘形张力弹簧。
发明内容
本发明涉及一种装置，该装置包括经皮部件和插入器。所述经皮部件包括具有安装表面的安装部分、硬质套管、引导流体从流体源流向所述硬质套管的流体路径。所述插入器包括在使用前至少部分地覆盖所述经皮部件的包装物或由在使用前至少部分地覆盖所述经皮部件的包装物组成，所述包装物包括在正常使用过程中不能由使用者加以变形的不可变形部分和在使用过程中能够沿着插入方向被纵向缩短的可变形部分。
所述插入器和所述包装物由同样的材料件构成，这意味着浪费的数量将减少，并且使用者只需处理更少的单元。
按照一个实施例，所述安装表面至少部分具有粘性，通常所述安装表面在使用前由可去除衬垫覆盖以便保护一个或更多个粘性表面。所述安装表面至少部分具有粘性意味着可能所述安装表面上仅仅选定区域具有粘性。
按照一个实施例，在使用前所述可去除衬垫可构成所述包装物的外壳和所述经皮部件的粘性表面的一部分。
按照一个实施例，硬质板被附接到所述安装部分，该硬质板可具有由挠性材料制成的直线部分，该直线部分将所述硬质板划分为第一部分和第二部分，其中所述第二部分被固定至所述安装部分，所述第一部分可围绕由直线的所述挠性材料形成的轴a枢转。所述硬质板也可具有柔软的挠性材料的区域，例如围绕所述套管的插入点。
按照该实施例，所述第一部分和所述第二部分之间的角度α在第一位置小于90度，并大于由将被插入的所述硬质套管(9)的长度所限定的角度。
按照一个实施例，所述硬质套管可由钢或硬质塑料制成。
按照一个实施例，所述流体源是附接到所述安装部分的容器。
按照一个实施例，所述包装物可由硬质可变形塑料形成，例如，由两种或更多种具有不同受压缩性能(即材料缩短的程度)的硬质塑料形成。
按照一个实施例，所述安装部分可具有两个至少部分具有粘性的表面，一个表面朝向所述插入器包装物，一个表面朝向所述安装表面。这使得将所述装置放置并粘附于病人皮肤、并且随后将所述经皮部件粘附于所述安装部分的相对表面成为可能。
按照一个实施例，所述容器可装有胰岛素。
附图说明
现在将参考以下附图描述本发明的实施例，其中：
图1显示了经皮部件的一个实施例的俯视图，其已被置于病人皮肤上。
图2显示了经皮部件的第二实施例中的套管的放大侧视图。
图3a和图3b显示图2中的套管被置于经皮部件内，该经皮部件在套管插入前位于第一位置(图3a)，在套管被插入后位于第二位置(图3b)。
图4显示了经皮部件被置于病人皮肤上，该经皮部件具有部分地安装的泵送部分。
图5a和图5b显示了包装物的第二实施例，该包装物在套管插入前位于第一位置(图5a)，在套管被插入后位于第二位置(图5b)。
图6a-6f显示了包装物/插入器的第三实施例，其经过定位、插入和进入工作的步骤。
具体实施方式
图1显示了经皮部件的第一实施例，所述经皮部件包括套管，该套管能够利用本发明的插入器而被插入。所述插入器也可被用于例如需要注射单一剂量药物的免疫接种。所述经皮部件包括具有安装表面2的安装部分1，由于安装所述装置后所述安装表面变成朝向病人并与病人接触，因而图中未示出所述安装表面。所述安装部分1可由柔性材料制造，该材料能够调整以适应病人的皮肤表面，所述安装表面可为部分或全部覆盖所述安装部分的下侧面的粘合剂，所述下侧面即所述安装部分1在使用中朝向病人的侧面。按照一个实施例，所述安装部分1在上侧面和下侧面上都包括粘合剂，即，在安装表面2上和相对表面上都包括粘合剂。另外，所述安装部分1可具有由更柔软并更具挠性的材料形成的部分(显示为围绕套管部分的阴影区域)。所述更柔软并更具挠性的材料例如可为TPE。
由更硬并且更少挠性的材料形成的板3被固定于所述安装部分2的顶部。所述板3具有两根轨道4a和4b，该轨道对应于所述经皮部件的对应的盖5中的凹槽或钩。所述盖5可包括泵和用于给予正确数量的药物的装置。容器6也可被直接或间接地附接到所述板3。如果所述容器6间接附接到所述板，其将通过连接器针8附接到连接器部分7。所述连接器部分7提供了通向套管9的流体路径，并可由例如PUR或TPE制造。所述套管9由硬质材料制造，并具有尖的端部，该端部可刺穿皮肤。“硬质材料”是指坚硬得足以穿透病人的皮肤表面并保持其原始形状的材料。按照一个实施例，所述套管是钢针-G29，长5mm。通常所述针不到10mm长，此处长度是指超过病人皮肤的程度。
图2显示了经皮部件的一部分的第二实施例的放大图。所述套管9包括由硬质材料制造的弯针，所述硬质材料可为例如钢或硬质塑料。所述连接器部分7被附接到所述板3，所述板3具有由柔软的挠性材料3a形成的区域。在柔软的挠性材料3a的区域中，板3例如可沿着所述柔软材料形成的线弯曲。所述柔软的挠性材料例如可为TPE层。
图3a和3b显示了图2所示的套管部分位于经皮部件上。所述经皮部件被置于按照本发明的实施例的包装物内。所述包装物由硬质顶部10结合可压缩部分10a形成。这样的包括物可由多于一种材料制造，但可选择地，部分10和10a的不同特性也可通过改变材料的形态(例如所述材料可在可压缩部分10a处形成波纹状)或厚度(例如所述材料可在可压缩部分10a处设置得更薄)来实现。用于所述包装物的合适的材料例如为PP。图3a显示了在插入前所述经皮部件和所述包装物所处的状态，图3b显示了所述两个单元在所述套管插入后所处的状态。
在插入前，所述包装物形成封闭的无菌室，所述经皮部件被保存在该无菌室中。所述包装物的顶部10、10a气密地连接于所述安装部分1，从而形成所述无菌室。
所示实施例中的包装物10包括由波纹状材料10a形成的区域，所述区域可沿着插入方向被压缩，即所述包装物10的尺寸在该方向上减小。在包装物10未形成波纹的区域中，该包装物由确保所述包装物在正常使用和存储时尺寸不发生变化的材料和形状形成。当使用者打算使用该装置时，该使用者首先撕去保护所述粘性安装表面2的可去除衬垫11，在使用中该表面将所述经皮部件固定到病人，然后使用者将所述包装物10向下推向病人皮肤。当所述包装物10被推向皮肤时，所述板3的第一部分与病人皮肤接触并位于固定位置，而由于所述板3围绕与板3的挠性材料3a部分平行的轴a弯曲，所述板3的第二部分从病人皮肤抬起。当使用者希望插入套管9时，使用者如箭头所示在所述包装物10的顶部上向下推。这一动作导致板3的第二部分绕轴a枢转，使板3变直，套管9先刺穿所述安装部分1，然后刺穿病人皮肤。最终所述包装物10从所述经皮部件上除去并被处置。由于所述包装物和所述插入器由相同材料构成，与插入器为分离单元的类似产品相比，浪费的数量减少了。
图4显示了图1所示的经皮部件在套管9已经被经皮插入病人皮肤中之后的状态。所述经皮部件由盖部分地覆盖，该盖位于到达其终止位置的半途中，为将盖5移至其终止工作位置，需要沿箭头方向向前推盖5。可以看见容器6的连接器针8位于盖5之下，并且当盖5位于工作位置时，连接器针8将刺穿覆盖连接器部分7的入口的保护层。所述装置可由患有糖尿病的病人使用，此时容器6将装有胰岛素。
图5a和5b显示了按照本发明的插入器的第二实施例。所述经皮部件由于其被所述包装物完全覆盖而不可见。按照本实施例，包装物10为盒体形式，其中包装物10的波纹部分10a沿盒体的侧边设置。当插入器-包装物已经被置于病人皮肤上并且将被致动时，使用者向下推保护顶部从而导致经皮部件的未示出的套管被插入皮肤。插入器的该实施例可被制成两部件注塑模制组件。
图6a-6f显示了按照本发明的插入器的第三实施例。与在先描述的实施例中的相同附图标记表示相同部件。
图6a显示了在使用前具有可去除衬垫11的封闭包装物。
图6b显示了即将使用的不具有可去除衬垫11的封闭包装物。
图6c显示了所述硬质套管9插入之后的封闭包装物。
图6d显示了所述套管9插入之后、包装物/插入器已经被移除的经皮部件。
图6e显示了盖位于其到达终止位置的半途中时的所述经皮部件，本例中盖具有泵和控制器以及流体容器6。
图6f显示了所述经皮部件位于其最终工作位置，此时流体被向病人输注。

Claims (13)

1.一种包括经皮部件和插入器的装置，其中，
所述经皮部件包括：
-具有安装表面(2)的安装部分(1)，
-硬质套管(9)，
-引导流体从流体源流向所述硬质套管(9)的流体路径，
所述插入器包括：
-使用前至少部分地覆盖所述经皮部件的包装物(10)，该包装物(10)包括：
——在正常使用过程中不能由使用者加以变形的不可变形部分，
——在使用过程中能够沿着插入方向被纵向地缩短的可变形部分(10a)。
2.按照权利要求1所述的装置，其中，所述安装表面(2)至少部分具有粘性。
3.按照权利要求2所述的装置，其中，所述安装表面(2)由可去除衬垫(11)覆盖。
4.按照权利要求3所述的装置，其中，所述可去除衬垫(11)在使用前构成所述包装物的外壳和所述经皮部件的粘性表面的一部分。
5.按照上述权利要求中的任一项所述的装置，其中，硬质板(3)被附接到所述安装部分(1)。
6.按照权利要求5所述的装置，其中，所述硬质板(3)具有由挠性材料(3a)制成的直线部分，该直线部分将所述硬质板(3)划分为第一部分和第二部分，其中所述第二部分被固定至所述安装部分(1)，所述第一部分能够围绕由直线的所述挠性材料(3a)形成的轴a枢转。
7.按照权利要求6所述的装置，其中，所述第一部分和所述第二部分之间的角度α在第一位置小于90度，并大于由将被插入的所述硬质套管(9)的长度所限定的角度。
8.按照上述权利要求中的任一项所述的装置，其中，所述安装部分(1)具有围绕所述套管(9)的插入点的挠性部分。
9.按照上述权利要求中的任一项所述的装置，其中，所述硬质套管(9)由钢或硬质塑料制成。
10.按照上述权利要求中的任一项所述的装置，其中，所述流体源(6)是附接到所述安装部分(1)的容器。
11.按照上述权利要求中的任一项所述的装置，其中，所述包装物(10，10a)由硬质可变形塑料形成，例如，由两种或更多种具有不同受压缩性能的硬质塑料形成。
12.按照上述权利要求中的任一项所述的装置，其中，所述安装部分(1)具有两个至少部分具有粘性的表面，一个表面朝向所述插入器包装物(10，10a)，一个表面朝向所述安装表面(2)。
13.按照上述权利要求中的任一项所述的装置，其中，所述容器(6)装有胰岛素。
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US20110137257A1 (en) 2011-06-09
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WO2010003886A1 (en) 2010-01-14

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