WO2017088153A1 - Dispositif de détection de fuite pour dispositifs médicaux - Google Patents

Dispositif de détection de fuite pour dispositifs médicaux 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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WO
WIPO (PCT)
Prior art keywords
electrode
electrode wires
short
substrate
alarm
Prior art date
Application number
PCT/CN2015/095712
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English (en)
Chinese (zh)
Inventor
文霞
Original Assignee
深圳市泽智知识产权有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 深圳市泽智知识产权有限公司 filed Critical 深圳市泽智知识产权有限公司
Priority to CN201580083833.1A priority Critical patent/CN108348675B/zh
Priority to PCT/CN2015/095712 priority patent/WO2017088153A1/fr
Publication of WO2017088153A1 publication Critical patent/WO2017088153A1/fr

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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)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • 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

L'invention concerne un dispositif de détection de fuite (30) pour dispositifs médicaux, comprenant un substrat (31) ayant une partie périphérique pour entourer et exposer une zone de contact (11) du dispositif médical à la peau; un circuit de détection de fuite (32) disposé sur une surface supérieure du substrat (31) et comprenant un premier fil d'électrode (321) et un second fil d'électrode (322) espacés l'un de l'autre, qui sont rendus conducteurs et court-circuités lorsqu'ils sont traversés par un liquide; et un module d'alarme (33) électriquement connecté auxdits premier et second fils d'électrode, qui est déclenché lorsque lesdits premier et second conducteurs d'électrode sont rendus conducteurs et court-circuités. Le dispositif de détection de fuite (30) peut facilement et précisément réaliser la détection de fuite, à faible coût, avec un procédé simple, et avec une grande précision et une grande sécurité.
PCT/CN2015/095712 2015-11-26 2015-11-26 Dispositif de détection de fuite pour dispositifs médicaux WO2017088153A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201580083833.1A CN108348675B (zh) 2015-11-26 2015-11-26 用于医疗器械的漏液检测装置
PCT/CN2015/095712 WO2017088153A1 (fr) 2015-11-26 2015-11-26 Dispositif de détection de fuite pour dispositifs médicaux

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2015/095712 WO2017088153A1 (fr) 2015-11-26 2015-11-26 Dispositif de détection de fuite pour dispositifs médicaux

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WO2017088153A1 true WO2017088153A1 (fr) 2017-06-01

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CN107728056A (zh) * 2017-11-20 2018-02-23 国网山东省电力公司龙口市供电公司 一种具备报警功能的漏电保护测试仪
WO2019120436A1 (fr) 2017-12-22 2019-06-27 Coloplast A/S Appareil de stomie comprenant une partie de plaque de base en couches et/ou d'ensemble capteur et procédés associés
WO2019120426A1 (fr) 2017-12-22 2019-06-27 Coloplast A/S Plaque de base et partie d'ensemble capteur pour un appareil de stomie
WO2019161861A1 (fr) 2018-02-20 2019-08-29 Coloplast A/S Partie d'ensemble capteur et plaque de base pour un appareil de stomie et dispositif de connexion à une plaque de base ou à une partie d'ensemble capteur
WO2019161860A1 (fr) 2018-02-20 2019-08-29 Coloplast A/S Procédés de changement d'appareil de stomie et dispositifs accessoires associés d'un système de stomie
TWI679966B (zh) * 2018-09-05 2019-12-21 蔡韋德 洗腎病人溢血偵測警示裝置
CN111249572A (zh) * 2020-02-05 2020-06-09 翔安生医科技股份有限公司 生命体征监测系统
CN111317454A (zh) * 2020-02-28 2020-06-23 南通大学 一种用于中央凶险型前置胎盘流血的报警设备
CN111879019A (zh) * 2020-06-12 2020-11-03 浙江大学 一种利用电极片检测光热发电储热装置熔盐泄漏的系统
US10987243B2 (en) 2006-02-28 2021-04-27 Coloplast A/S Method of detecting detachment of an ostomy device from a patient
TWI744213B (zh) * 2021-05-14 2021-10-21 亞東學校財團法人亞東科技大學 靜脈注射異常檢測系統
EP3727240B1 (fr) 2017-12-22 2021-12-01 Coloplast A/S Dispositifs accessoires d'un système de stomie et procédés associés pour communiquer un état de fonctionnement
EP3727232B1 (fr) 2017-12-22 2022-01-26 Coloplast A/S Appareil de stomie comportant des points de capteur sélectifs et procédés associés
EP3727234B1 (fr) 2017-12-22 2022-01-26 Coloplast A/S Appareil de stomie avec détection de fuite angulaire
CN114080204A (zh) * 2019-06-14 2022-02-22 霍利斯特公司 造口术器具的渗漏检测系统
USD970017S1 (en) 2020-08-25 2022-11-15 Coloplast A/S Ostomy appliance monitor
US11517469B2 (en) 2019-01-31 2022-12-06 Coloplast A/S Base plate and sensor assembly part of an ostomy system having a moisture sensor
US11534323B2 (en) 2017-12-22 2022-12-27 Coloplast A/S Tools and methods for placing a medical appliance on a user
US11540937B2 (en) 2017-12-22 2023-01-03 Coloplast A/S Base plate and sensor assembly of a medical system having a leakage sensor
US11589811B2 (en) 2017-12-22 2023-02-28 Coloplast A/S Monitor device of a medical system and associated method for operating a monitor device
US11590015B2 (en) 2017-12-22 2023-02-28 Coloplast A/S Sensor assembly part and a base plate for a medical appliance and a method for manufacturing a sensor assembly part and a base plate
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US11612512B2 (en) 2019-01-31 2023-03-28 Coloplast A/S Moisture detecting base plate for an ostomy appliance and a system for determining moisture propagation in a base plate and/or a sensor assembly part
US11612508B2 (en) 2017-12-22 2023-03-28 Coloplast A/S Sensor assembly part for a medical appliance and a method for manufacturing a sensor assembly part
US11627891B2 (en) 2017-12-22 2023-04-18 Coloplast A/S Calibration methods for medical appliance tools
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US11701248B2 (en) 2017-12-22 2023-07-18 Coloplast A/S Accessory devices of a medical system, and related methods for communicating leakage state
US11707377B2 (en) 2017-12-22 2023-07-25 Coloplast A/S Coupling part with a hinge for a medical base plate and sensor assembly part
US11707376B2 (en) 2017-12-22 2023-07-25 Coloplast A/S Base plate for a medical appliance and a sensor assembly part for a base plate and a method for manufacturing a base plate and sensor assembly part
EP3727219B1 (fr) 2017-12-22 2023-08-09 Coloplast A/S Plaque de base de détection d'humidité pour un appareil de stomie et système de détermination de propagation d'humidité dans une plaque de base et/ou une partie d'ensemble capteur
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US11865029B2 (en) 2017-12-22 2024-01-09 Coloplast A/S Monitor device of a medical system having a connector for coupling to both a base plate and an accessory device
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US11096818B2 (en) 2006-02-28 2021-08-24 Coloplast A/S Ostomy appliance having an electrode
US11890219B2 (en) 2014-04-17 2024-02-06 Coloplast A/S Thermoresponsive skin barrier appliances
CN107728056B (zh) * 2017-11-20 2023-10-24 国网山东省电力公司龙口市供电公司 一种具备报警功能的漏电保护测试仪
CN107728056A (zh) * 2017-11-20 2018-02-23 国网山东省电力公司龙口市供电公司 一种具备报警功能的漏电保护测试仪
US11590015B2 (en) 2017-12-22 2023-02-28 Coloplast A/S Sensor assembly part and a base plate for a medical appliance and a method for manufacturing a sensor assembly part and a base plate
US11786392B2 (en) 2017-12-22 2023-10-17 Coloplast A/S Data collection schemes for an ostomy appliance and related methods
US11612508B2 (en) 2017-12-22 2023-03-28 Coloplast A/S Sensor assembly part for a medical appliance and a method for manufacturing a sensor assembly part
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