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WO2017088153A1 - 用于医疗器械的漏液检测装置 - Google Patents

用于医疗器械的漏液检测装置 Download PDF

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Publication number
WO2017088153A1
WO2017088153A1 PCT/CN2015/095712 CN2015095712W WO2017088153A1 WO 2017088153 A1 WO2017088153 A1 WO 2017088153A1 CN 2015095712 W CN2015095712 W CN 2015095712W WO 2017088153 A1 WO2017088153 A1 WO 2017088153A1
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electrode
electrode wires
short
substrate
alarm
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French (fr)
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文霞
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Shenzhen Zezhi Intellectual Property Co Ltd
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Shenzhen Zezhi Intellectual Property Co Ltd
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Priority to PCT/CN2015/095712 priority Critical patent/WO2017088153A1/zh
Priority to CN201580083833.1A priority patent/CN108348675B/zh
Publication of WO2017088153A1 publication Critical patent/WO2017088153A1/zh
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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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • 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

Definitions

  • the invention relates to a detecting device, in particular to a medical device leak detecting device.
  • the technical problem to be solved by the present invention is to provide a liquid leakage detecting device for a medical device to detect whether or not liquid leakage occurs in a region where the medical device is in contact with the skin.
  • the present invention provides a liquid leakage detecting device for a medical device, comprising:
  • a substrate having a surrounding portion for surrounding and exposing a contact area of the medical device with the skin;
  • the liquid leakage detecting circuit is disposed on the upper surface of the substrate, and includes at least a first electrode wire and a second electrode wire.
  • the first and second electrode wires are spaced apart by a distance, and are short-circuited when being bridged by the liquid.
  • the alarm module may further be electrically connected to different electrode wires, and an alarm is triggered according to the short-circuit conduction between the different electrode wires.
  • the detection of liquid leakage can be realized very conveniently and accurately, the cost is low, the process is simple, and the sensitivity, the accuracy and the safety are high.
  • FIG. 1 is a schematic diagram of an embodiment of a liquid leakage detecting device for a medical device according to an embodiment of the present invention.
  • FIG. 2 is a schematic diagram showing details of a liquid leakage detecting circuit according to an embodiment of the present invention.
  • FIG. 3 is a detailed diagram of a liquid leakage detecting circuit according to an embodiment of the present invention.
  • FIG. 4 is a detailed diagram of a liquid leakage detecting circuit according to an embodiment of the present invention.
  • FIG. 5 is a detailed diagram of a liquid leakage detecting circuit according to an embodiment of the invention.
  • FIG. 6 is a detailed diagram of a liquid leakage detecting circuit according to an embodiment of the invention.
  • the present invention first provides an embodiment of a liquid leakage detecting device for a medical device.
  • a medical needle as an example, as shown in Fig. 1, at the time of infusion or dialysis, the needle 20 is generally tied to the inside of the arm 10, thereby forming a contact area 11 of the needle with the skin.
  • the range of the contact area is not limited to FIG. 1 , and may be expanded or reduced according to different technical needs and the contact manner of the medical device with the skin in actual use.
  • a liquid leakage detecting device 30 is provided around the contact area 11 according to an embodiment of the present invention.
  • the detecting device 30 located in the vicinity of the contact area, may include:
  • the substrate 31 has a surrounding portion for surrounding and exposing the contact area 11 of the medical device and the skin;
  • the liquid leakage detecting circuit 32 is disposed on the upper surface of the substrate 31 and includes at least a first electrode lead 321 and a second electrode lead 322.
  • the first and second electrode leads are spaced apart by a distance and are connected by a liquid. Conduction short circuit
  • the alarm module 33 is electrically connected to different electrode wires, and triggers an alarm according to the short-circuit conduction between the different electrode wires.
  • the alarm module 33 can supply power to the detecting circuit 32, and can be short-circuited or disconnected according to different electrode wires, and a short circuit or a short circuit occurs.
  • the combination of the broken electrode wires and the like trigger different alarm levels, but the combination of the alarm module and the substrate 31 and the detecting circuit 32 may be an integral connection or a split connection.
  • the substrate 31 and the liquid leakage The detecting circuit 32 can separately constitute a liquid leakage detecting device, which can be separately sold, and then combined with the alarm module 33, can be applied to the clinic. In this way, the alarm module can be reused even after the substrate is stained, saving the overall cost.
  • the substrate 31 may be in a form of full or semi-enclosed to surround the contact area 11 as long as the medical device is prevented from contacting the electrode lead; the first and second electrode leads of the detecting circuit 32 may respectively form a
  • the extension portion is electrically connected to the alarm module 33, or the alarm module is electrically connected to different electrode wires through a wire extension portion; the shape of the detection circuit 32 and the electrode wire may also be other patterns, preferably,
  • the substrate 31 is disposed around the contact region 11, for example, the surrounding portion of the substrate 31 has an inner edge adjacent to the contact region and an outer edge of the opposite side; the first electrode wire is distributed along the inner edge The second electrode lead is distributed along the outer edge to monitor leakage as much as possible.
  • At least one intermediate electrode lead may be further included, the different electrode leads being spaced apart by a distance, and guided by the liquid bridge Short circuit.
  • the detecting circuit 32 may further include a third electrode lead (an intermediate electrode lead) 323 spaced apart from the first and second electrode leads, and when connected by a liquid And/or the second electrode wire is electrically shorted; and the alarm module 33 is electrically connected to the third electrode wire, when the third electrode wire is short-circuited with the first and/or second electrode wires, Touch Send an alarm. Since the distance and position between the different electrode wires are predicted, the amount of liquid leakage and the extended area can be perceived according to the short circuit condition between the different electrode wires, such as short circuit between the first electrode wire 321 and the third electrode wire 323.
  • the distribution patterns of the first, second, and third electrode wires are not limited to FIG. 3, and may be other distribution modes, for example, as shown in FIG. 4, which is another distribution pattern of different electrode wires, second and third.
  • the electrode wires 322 and 323 are the same distance as the first electrode wire 321 but are opposite in position, so that when the first electrode wire 321 is short-circuited with the second electrode wire 322 or the third electrode wire 323, a first-level alarm is triggered, and when When one electrode lead 321 and the second electrode lead 322 and the third electrode lead 323 are short-circuited, a secondary alarm is triggered. The more short-circuit points, the larger the leakage area, so the alarm level is higher.
  • the more detection regions that can be formed, the more accurate the detection of the liquid leakage, and the alarm level can be adjusted accordingly.
  • the distance between the individual electrode wires can be reduced.
  • the specific shape of the electrode wires can also be designed to increase the density of the electrode wire distribution, for example, in the leakage At least one interlaced sensing region is designed between the different electrode leads of the detecting circuit, and in the interleaved sensing region, the different electrode wires form a closely adjacent staggered shape.
  • At least one interlaced sensing region 324 is disposed between the different electrode leads 321, 322.
  • a plurality of interleaved sensing regions are evenly distributed according to the surrounding shape, and in the interlaced sensing region 324, The different electrode wires form a closely interlaced shape.
  • the leaking liquid flows through the first electrode lead 321 but has not flown to the second electrode lead 322, if there is no interlaced sensing area 324, the short circuit alarm is not triggered, but if it just flows through the interlaced sensing area 324, A short circuit alarm can occur immediately. If the number of distributions of the interlaced sensing regions is further increased, the sensitivity can be further enhanced.
  • the liquid leakage detecting circuit includes a plurality of intermediate electrode wires in addition to the first and second electrode wires
  • multi-point detection between different electrode wires can be formed by designing an interlaced sensing region between the two electrode wires.
  • the alarm module can sense the number and/or position of the electrode leads that are short-circuited. Knowing the amount of liquid leakage and the area of the leak, it is possible to trigger different alarm levels.
  • At least one interlaced sensing region is respectively disposed between the first electrode lead 321 and the remaining electrode leads, and in the interleaved sensing region, the different electrode leads form a closely interlaced shape.
  • the alarm module triggers different alarm levels according to the position and/or number of electrode wires that are short-circuited.
  • the substrate is a flexible substrate, so that the substrate is adapted to the shape of the body surface, so that the liquid leakage detecting device is more compliant and attached to the body surface region.
  • the lower surface of the substrate may have a layer of adhesive material, and the liquid leakage detecting device is directly attached to the body surface region in a patch shape. If the adhesive material is not used, the leakage detecting device can be fixed to the body surface region by using an auxiliary material such as gauze or a bandage, which is not limited in the present invention.
  • the liquid leakage detecting device may further include a tape layer, the substrate and the liquid leakage detecting circuit being disposed on the upper surface of the tape layer, and having a paste on the lower surface of the tape layer Material layer.
  • At least one side end of the tape layer may have an easy-to-tear portion connected to the tape layer side end of another liquid leakage detecting device to form a continuous structure. This makes it easy to store and use.
  • the liquid leakage detecting device may further include a cover layer covering the substrate and the liquid leakage detecting circuit; the covering layer may be a layer of a permeating material, such as gauze, bandage, etc. Medical aids.
  • the lower surface of the substrate has a separation detecting circuit including an A-electrode wire and a B-th electrode wire, and the A- and B-th electrode wires They are separated by a distance and short-circuited when in contact with the skin of the body surface.
  • the alarm module can be electrically connected to the A and B electrode wires respectively, and an alarm is triggered when the A and B electrode wires are short-circuited and then open.
  • the alarm module can be electrically connected to different electrode wires by conductive clamps and/or pins.
  • the leakage detecting device may further include a fixing component for fixing the medical device to the contact area;
  • the lower surface of the fixing member may be fixed to the body surface region by an adhesive material layer or a gauze or the like, and the lower surface of the fixing member has a first electrode lead and a bth electrode lead, and the a-th and b-th electrode leads are spaced apart by a distance, and Short-circuit conduction when in contact with the skin of the body surface.
  • the alarm module can be electrically connected to the first and fourth electrode wires, respectively, and when an open circuit occurs after the first and second electrode wires are short-circuited, an alarm is triggered.
  • the fixing member may be combined with the substrate for fixing the medical device to the contact area, and the fixing element may include:
  • a ridge for receiving and holding the medical device through the ridge
  • a side wing portion extending outwardly from both sides of the ridge portion, made of a flexible material for operating the medical device through the side wing portion; the lower surfaces of the two side wing portions respectively have a sensing electrode lead, when operating a side wing portion and short-circuiting when the two sensing electrode wires are in contact;
  • the alarm module can be electrically connected to the two sensing electrode wires respectively, and an alarm is triggered when the two sensing electrode wires are short-circuited and then open.
  • liquid leakage detecting device may further include a body temperature sensor such as temperature, humidity, pH value, heart rate, etc., and is electrically connected to the alarm module, and is triggered according to a deviation from a preset physical threshold. Call the police.
  • a body temperature sensor such as temperature, humidity, pH value, heart rate, etc.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
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  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Urology & Nephrology (AREA)
  • External Artificial Organs (AREA)
  • Investigating Or Analyzing Materials By The Use Of Electric Means (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

一种用于医疗器械的漏液检测装置（30），包括基板（31），其具有一围绕部，用于围绕并暴露出该医疗器械与皮肤的接触区域（11）；漏液检测电路（32），置于该基板（31）的上表面，包括第一电极导线（321）与第二电极导线（322），该第一与第二电极导线间隔一段距离，并在被液体跨越时导通短路；报警模块（33），与所述第一与第二电极导线电性连接，当所述第一与第二电极导线短路导通时，触发报警。通过该漏液检测装置（30）可以方便、准确地实现漏液的检测，成本低廉、工艺简单、准确率及安全性高。

Description

用于医疗器械的漏液检测装置 技术领域
本发明涉及一种检测装置，特别涉及一种用于医疗器械漏液检测装置。
背景技术
现在有很多医疗器械是需要与人体长时间相接触的，例如针具，在打点滴或者输液，特别是洗肾透析时，针头需要长时间插进皮肤下的血管中，而一旦针头非正常的脱出，则很可能造成漏血或感染，甚至发生生命危险。除了漏血，其他漏液情况也会经常发生，例如人体的组织液，或者医疗器械输送的营养液等。
造成针头非正常脱出的情况有很多，例如针具本身的问题，或者是患者熟睡中的无意识或者精神烦躁时的躁动引起，但很多时候并不能及时被发现，由此造成了安全隐患。
目前虽然有一些装置可以用来检测脱针及漏血，例如通过对针具导管中流经的血液的成分或者颜色进行分析。但现有的检测方式所需要的设备过于复杂，制造成本高，而且使用起来也并不舒适和方便。
发明内容
本发明所要解决的技术问题在于提供一种用于医疗器械的漏液检测装置，以对医疗器械与皮肤接触的区域中是否发生漏液进行检测。
为解决上述技术问题，本发明提供一种用于医疗器械的漏液检测装置，包括：
基板，具有一围绕部，用于围绕并暴露出所述医疗器械与皮肤的接触区域；
漏液检测电路，置于所述基板的上表面，至少包括第一电极导线与第二电极导线，所述第一与第二电极导线间隔一段距离，在被液体跨接时导通短路。
还可以进一步包括报警模块，与不同电极导线分别电性连接，并根据所述不同电极导线之间的短路导通情况，触发报警。
通过本发明的实施例，可以非常方便、准确的实现漏液的检测，成本低廉，工艺简单，灵敏度、准确率及安全性都很高。
附图说明
图1为根据本发明实施例所述的用于医疗器械的漏液检测装置的实施例示意图。
图2为根据本发明实施例所述的漏液检测电路细节示意图。
图3为根据本发明实施例所述的漏液检测电路细节示意图。
图4为根据本发明实施例所述的漏液检测电路细节示意图。
图5为根据本发明实施例所述的漏液检测电路细节示意图。
图6为根据本发明实施例所述的漏液检测电路细节示意图。
具体实施方式
为更进一步阐述本发明为达成预定发明目的所采取的技术手段及功效,下面将结合附图，通过多个实施例对本发明的技术方案进行详细说明。多个实施例之间，对于相同或近似部件及方法步骤的实现方式、工作原理以及有益效果等，是可以相互参考和引用的，出于篇幅考虑，可能不会在每个实施例中都进行详细的陈述，在此事先陈明。
本发明首先提供一种用于医疗器械的漏液检测装置的实施例。以医疗针具为例，如图1所示，在输液或透析时，针具20一般扎在手臂10的内侧，由此形成一个针具与皮肤的接触区域11。该接触区域的范围不以图1为限，实际使用中可以根据不同的技术需要，以及医疗器械与皮肤的接触方式而扩大或缩小。而围绕所述接触区域11而设置的则是本发明实施例所述的漏液检测装置30。
如图2所示，根据本发明实施例所述的检测装置30，位于接触区域附近，可以包括：
基板31，具有一围绕部，用于围绕并暴露出所述医疗器械与皮肤的接触区域11；
漏液检测电路32，置于所述基板31的上表面，至少包括第一电极导线321与第二电极导线322，所述第一与第二电极导线间隔一段距离，并在被液体跨接时导通短路；
报警模块33，与不同电极导线分别电性连接，并根据所述不同电极导线之间的短路导通情况，触发报警。
图2所示仅为本发明实施方式之一，实际应用并不限于与此，例如，报警模块33可以为检测电路32供电，并可以根据不同电极导线之间是短路还是断路，以及发生短路或断路的电极导线的组合等情况，触发不同的报警级别，但是报警模块与基板31及检测电路32的结合，可以是一体连接，也可以是分体式连接，当分体连接时，基板31及漏液检测电路32即可单独构成一个漏液检测装置，独立售卖，再与报警模块33结合后，即可应用于临床。如此，即便基板污损后，报警模块仍可重复使用，节省了总体成本。
此外，基板31可以是全包围或半包围等形态而围绕所述接触区域11，只要避免医疗器械接触导通所述电极导线即可；检测电路32的第一及第二电极导线可分别形成一个延伸部与报警模块33电性连接，或者，所述报警模块通过一导线延伸部与不同的电极导线电性连接；检测电路32以及电极导线的形状也可以是其他样式，优选的，可随着基板31的形态而围绕所述接触区域11而设置，例如，所述基板31的围绕部具有一靠近接触区域的内沿及相对侧的外沿；所述第一电极导线沿所述内沿分布，所述第二电极导线沿所述外沿分布，以尽量全方位的监测到漏液。
根据本发明的另一实施例，除了所述第一与第二电极导线以外，还可以进一步包括至少一个中间电极导线，所述不同电极导线之间间隔一段距离，并在被液体跨接时导通短路。
如图3所示，所述检测电路32，可以进一步包括第三电极导线(一个中间电极导线)323，与所述第一及第二电极导线间隔一段距离，并在被液体跨接时与第一和/或第二电极导线导通短路；而所述报警模块33，与所述第三电极导线电性连接，当所述第三电极导线与第一和/或第二电极导线短路时，触 发报警。由于不同电极导线之间的距离和位置是预知的，因此，可根据不同电极导线之间的短路情况感知到漏液的多寡以及漫延的面积，如第一电极导线321与第三电极导线323短路时，触发一级报警，而当第三电极导线323与第二电极导线322短路时，触发二级报警，由于第二电极导线的位置更靠近外沿，说明漏液程度更高，漫延的面积增大，因此，二级报警的级别高于一级报警的级别。
上述第一、第二、第三电极导线的分布形态不以图3为限，也可以是其他分布形态，例如图4所示，为另一种不同电极导线的分布形态，第二和第三电极导线322、323与第一电极导线321的距离相同，但位置相对，这样，当第一电极导线321与第二电极导线322或第三电极导线323短路时，触发一级报警，而当第一电极导线321与第二电极导线322及第三电极导线323都发生短路时，触发二级报警。短路点越多，说明漏液漫延面积越大，因此报警级别也越高。
当漏液检测电路中分布的不同电极导线越多时，其可形成的检测区域也越多，对漏液多寡的检测也就越精确，报警级别也可相应的调整。
为进一步增加检测的敏感度，一方面可以减小各个电极导线之间的距离，另一方面，还可以对电极导线的具体形态进行设计，以增加电极导线分布的密度，例如，可以在漏液检测电路不同的电极导线之间设计至少一个交织感测区域，在所述交织感测区域，所述不同电极导线形成紧密相临的交错形状。
如图5所示，即为在不同电极导线321、322之间设置至少一个交织感测区域324，最好是按照围绕形态平均分布多个交织感测区域，在所述交织感测区域324，所述不同电极导线形成紧密相临的交错形状。当漏液流经第一电极导线321，但还未流到第二电极导线322之前，如果没有交织感测区域324，则不会触发短路报警，但如果恰好流经交织感测区域324时，即可立刻发生短路报警。如果进一步增加交织感测区域的分布数量，则可进一步强化灵敏度。
而当漏液检测电路中除第一及第二电极导线外还包括多个中间电极导线时，通过在两两电极导线之间设计交织感测区域即可形成不同电极导线之间的多点检测，报警模块可根据发生短路导通的电极导线的数量和/或位置，感 知到漏液的多寡以及漏液的面积，由此可触发不同的报警级别。
举例来说，如图6所示，第一电极导线321与其余电极导线之间分别设计至少一个交织感测区域，在所述交织感测区域，所述不同电极导线形成紧密相临的交错形状。如此，由于其余电极导线与第一电极导线之间具有距离与位置的对应性，因此，所述报警模块根据发生短路导通的电极导线的位置和/或数量，触发不同的报警级别。
本发明实施例所述基板为柔性基板，以便使基板与体表的形态相适应，使漏液检测装置更加服帖的贴附于体表区域。
所述基板下表面可以具有粘贴材料层，使所述漏液检测装置以贴片形状直接贴附于体表区域。如果不使用粘贴材料，则可以使用纱布、绷带等辅助材料将漏液检测装置固定于体表区域，本发明对此不做限制。
此外，根据本发明的实施例，所述漏液检测装置还可以进一步包括一胶带层，所述基板及漏液检测电路置于所述胶带层上表面，而在所述胶带层下表面具有粘贴材料层。
所述胶带层的至少一侧端可具有易撕部，与另一漏液检测装置的胶带层一侧端连接，形成连续结构。如此，可方便储存及使用。
此外，根据本发明的实施例，所述漏液检测装置还可以进一步包括一覆盖层，覆于所述基板及漏液检测电路上方；所述覆盖层可以为渗透材料层，例如纱布、绷带等医疗辅助材料。
为防止漏液检测装置从体表脱落，根据本发明的另一实施例，所述基板下表面具有脱离检测电路，包括第A电极导线与第B电极导线，所述第A与第B电极导线间隔一段距离，并在与体表皮肤接触时短路导通。
而所述报警模块，可分别与所述第A及第B电极导线电性连接，当所述第A与第B电极导线短路导通后又发生断路时，触发报警。
在本发明实施例中，所述报警模块可通过导电夹钳和/或插针与不同的电极导线之间可分离式的电性连接。
为了使医疗器械更加服帖，根据本发明的实施例，所述漏液检测装置还可以包括一固定元件，用于将所述医疗器械服帖固定于所述接触区域；所述 固定元件下表面可通过粘性材料层或纱布等辅料固定于体表区域，所述固定元件下表面具有第a电极导线与第b电极导线，所述第a与第b电极导线间隔一段距离，并在与体表皮肤接触时短路导通。
而所述报警模块，可分别与所述第a及第b电极导线电性连接，当所述第a与第b电极导线短路导通后又发生断路时，触发报警。
根据本发明的另一实施例，所述固定元件可以与所述基板相结合，用于将所述医疗器械服帖固定于所述接触区域，所述固定元件可以包括：
隆起部，用于容纳并夹持所述医疗器械从所述隆起部穿过；
侧翼部，从所述隆起部两侧向外延伸形成，由柔性材料制成，用于通过所述侧翼部操作所述医疗器械；所述两侧翼部下表面分别具有一感应电极导线，当操作所述侧翼部并使所述两个感应电极导线相接触时短路导通；
而所述报警模块，可分别与所述两个感应电极导线电性连接，当所述两个感应电极导线短路导通后又发生断路时，触发报警。
此外，本发明实施例所述的漏液检测装置，还可以包括温度、湿度、PH值、心律等体征传感器，与所述报警模块电性连接，根据与预置的体征阈值的偏离情况，触发报警。

Claims (10)

  1. 一种用于医疗器械的漏液检测装置，其特征在于，包括：
    基板，具有一围绕部，用于围绕并暴露出所述医疗器械与皮肤的接触区域；
    漏液检测电路，置于所述基板的上表面，至少包括第一电极导线与第二电极导线，所述第一与第二电极导线间隔一段距离，在被液体跨接时导通短路。
  2. 如权利要求1所述的装置，其特征在于，进一步包括：报警模块，与不同电极导线分别电性连接，并根据所述不同电极导线之间的短路导通情况，触发报警。
  3. 如权利要求2所述的装置，其特征在于，所述漏液检测电路还包括至少一个位于所述第一与第二电极导线之间的中间电极导线，所述不同电极导线之间间隔一段距离，并在被液体跨接时导通短路。
  4. 如权利要求2所述的装置，其特征在于，所述漏液检测电路不同的电极导线之间具有至少一个交织感测区域，在所述交织感测区域，所述不同电极导线形成紧密相临的交错形状。
  5. 如权利要求3或4所述的装置，其特征在于，所述报警模块根据发生短路导通的电极导线的数量和/或位置，触发不同的报警级别。
  6. 如权利要求2所述的装置，其特征在于，所述基板为柔性基板，所述基板下表面具有粘贴材料层；所述装置进一步还包括覆盖层，覆于所述基板及漏液检测电路上方；所述覆盖层为渗透材料层。
  7. 如权利要求2所述的装置，其特征在于，所述基板下表面具有脱离检测电路，包括第A电极导线与第B电极导线，所述第A与第B电极导线间隔一段距离，并在与体表皮肤接触时短路导通；
    所述报警模块，分别与所述第A及第B电极导线电性连接，当所述第A与第B电极导线短路导通后又发生断路时，触发报警。
  8. 如权利要求2所述的装置，其特征在于，还包括一固定元件，用于将 所述医疗器械服帖固定于所述接触区域；所述固定元件下表面用于固定于体表区域，且具有第a电极导线与第b电极导线，所述第a与第b电极导线间隔一段距离，并在与体表皮肤接触时短路导通；
    所述报警模块，分别与所述第a及第b电极导线电性连接，当所述第a与第b电极导线短路导通后又发生断路时，触发报警。
  9. 如权利要求2所述的装置，其特征在于，还包括一固定元件，与所述基板相结合，用于将所述医疗器械服帖固定于所述接触区域，所述固定元件包括：
    隆起部，用于容纳并夹持所述医疗器械从所述隆起部穿过；
    侧翼部，从所述隆起部两侧向外延伸形成，由柔性材料制成，用于通过所述侧翼部操作所述医疗器械；所述两侧翼部下表面分别具有一感应电极导线，当操作所述侧翼部并使所述两个感应电极导线相接触时短路导通；
    所述报警模块，分别与所述两个感应电极导线电性连接，当所述两个感应电极导线短路导通后又发生断路时，触发报警。
  10. 如权利要求2所述的装置，其特征在于，还包括体征传感器，与所述报警模块电性连接，根据与预置的体征阈值的偏离情况，触发报警。
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