TW202007354A - Vital signs monitoring system for medical device - Google Patents

Abstract

This disclosure discloses a vital sign monitoring system for a medical device including a medical device, a vital sign sensing component, and a monitoring system; the vital sign sensing component includes a substrate having a surrounding portion and a connecting portion; the monitoring system includes an alarm module and a signal transmission module; the vital sign sensing component is configured to detect a patient's vital sign data and transmit the vital sign data to the monitoring system; the alarm module of monitoring system generates an alert signal according to the change of the vital sign data alarming, and transmits the alarm signal to a server through the signal transmission module, the server is configured to collect the alarm signal and integrate it into a terminal monitoring device through an operation process; in this disclosure, simultaneous detection of skin leakage and subcutaneous leakage can be achieved, and the physiological condition of the patient can be immediately reflected, thereby improving medical efficiency.

Description

Translated fromChinese

用於醫療器械的生命體徵監測系統Vital sign monitoring system for medical devices

本發明涉及一種生命體徵監測系統，特別涉及一種用於醫療器械的生命體徵監測系統。The invention relates to a vital signs monitoring system, in particular to a vital signs monitoring system for medical devices.

侵入性醫療會帶有一定創傷存在，創傷發生時若無即時妥善處理將會產生惡化的可能，但是現今許多醫療器械是需要侵入人體並與人體長時間接觸的，例如針具，在輸液或進行血液透析時，例如洗腎透析，整個療程時間約耗費三至四小時之久，此時針頭需要長時間侵入皮膚下的血管中，在療程中若針具發生異動則很可能造成漏血或感染，進而引發患者生命危險。除了漏血，其他漏液情況也會經常發生，例如人體的組織液，或者醫療器械輸送的營養液等。Invasive medical treatment will have a certain amount of trauma, and if there is no immediate and proper treatment when the trauma occurs, it may deteriorate. However, many medical devices today need to invade the human body and have long contact with the human body, such as needles, infusion or During hemodialysis, such as kidney dialysis, the entire treatment time takes about three to four hours. At this time, the needle needs to invade the blood vessels under the skin for a long time. If the needle moves during the treatment, it is likely to cause blood leakage or infection. , Which in turn causes the patient's life to be dangerous. In addition to blood leaks, other fluid leaks often occur, such as human body tissue fluids, or nutrient fluids delivered by medical devices.

造成針頭非正常脫落情況有很多，例如針具本身的問題，或者是患者休息中的無意識或者精神煩躁時的躁動引起，若患者與醫護人員沒有及時發現，容易出現患者大量出血的現象，即當在創傷發生時無法進行即時妥善處理的情況下，需要持續對創傷處進行監控以免創傷惡化。There are many situations that cause the needle to fall off abnormally, such as the problem of the needle itself, or the unconsciousness or restlessness of the patient when the patient is resting. If the patient and the medical staff do not find it in time, it is prone to massive bleeding of the patient. In the case where immediate and proper treatment cannot be performed when a trauma occurs, it is necessary to continuously monitor the trauma site to avoid deterioration of the trauma.

有鑑於此，本業者開發出一種用於醫療器械的生命體徵監測系統，能持續監控患者的生命體徵狀態，並透過數據傳輸將生命體徵數據傳輸至閘道器整合，並擁有一終端監控裝置將資訊呈現給相關人員，提高 醫療效率。In view of this, the industry has developed a vital sign monitoring system for medical devices, which can continuously monitor the vital sign status of patients, and transmit vital sign data to the gateway through data transmission for integration, and has a terminal monitoring device to Information is presented to relevant personnel to improve medical efficiency.

本發明所要解決的技術問題在於提供一種用於醫療器械的生命體徵監測系統，其能夠同時偵測皮上漏液情況以及偵測皮下的生命體徵數據，並透過數據傳輸將該生命體徵數據傳輸至閘道器(Gateway)整合，並擁有一終端監控裝置將整合資訊即時呈現給相關人員，提高醫療效率。The technical problem to be solved by the present invention is to provide a vital sign monitoring system for medical devices, which can simultaneously detect leakage on the skin and detect vital sign data under the skin, and transmit the vital sign data to Gateway (Gateway) integration, and has a terminal monitoring device to present integrated information to relevant personnel in real time, improving medical efficiency.

為解決上述技術問題，本發明提供一種用於醫療器械的生命體徵監測系統，包括一醫療器械、一生命體徵感測組件，以及一監控系統；其中，所述生命體徵感測組件包含一基板，所述基板具有一圍繞部與一連接部，且所述圍繞部用於圍繞並暴露出所述醫療器械與皮膚的接觸區域；所述監控系統，包含一警示模組與一信號傳輸模組，所述警示模組電性連接於所述生命體徵感測組件。To solve the above technical problems, the present invention provides a vital sign monitoring system for medical devices, including a medical device, a vital sign sensing component, and a monitoring system; wherein, the vital sign sensing component includes a substrate, The substrate has a surrounding portion and a connecting portion, and the surrounding portion is used to surround and expose the contact area between the medical device and the skin; the monitoring system includes a warning module and a signal transmission module, The warning module is electrically connected to the vital sign sensing component.

所述生命體徵感測組件用以偵測一患者的生命體徵數據並將該生命體徵數據傳送至所述警示模組；所述警示模組根據所述生命體徵數據變化情況，產生一警示信號，並透過所述信號傳輸模組將所述警示信號傳輸到一閘道器，用以收集所述警示信號並透過運算處理整合至一終端監控裝置。The vital signs sensing component is used to detect vital signs data of a patient and transmit the vital signs data to the warning module; the warning module generates a warning signal according to the changes of the vital signs data, The signal transmission module transmits the warning signal to a gateway for collecting the warning signal and integrating it into a terminal monitoring device through arithmetic processing.

所述信號傳輸模組可以為有線傳輸模組或無線傳輸模組，不限於此。The signal transmission module may be a wired transmission module or a wireless transmission module, which is not limited thereto.

所述終端監控裝置可以為一顯示裝置，如電腦、筆電、平板以及手機等，不限於此。The terminal monitoring device may be a display device, such as a computer, a laptop, a tablet, a mobile phone, etc., and is not limited thereto.

作為本發明的改進，所述生命體徵感測組件可包括一皮上感 測器，設置於所述基板的上表面。所述皮上感測器包括一漏液檢測電路，置於所述圍繞部的上表面並向所述連接部延伸，該漏液檢測電路至少包括第一電極導線、第二電極導線與第三電極導線，所述第一、第二與第三電極導線間隔一段距離，在被液體跨接時接近短路，因此可以漏液擴散程度不同，觸發不同等級的警報，具有分級警示的效果。As an improvement of the present invention, the vital sign sensing assembly may include an on-skin sensor, which is disposed on the upper surface of the substrate. The above-skin sensor includes a liquid leakage detection circuit that is placed on the upper surface of the surrounding portion and extends toward the connection portion. The liquid leakage detection circuit includes at least a first electrode lead, a second electrode lead, and a third For electrode leads, the first, second, and third electrode leads are separated by a certain distance, and are close to a short circuit when they are bridged by liquid. Therefore, they can have different levels of leakage diffusion, trigger different levels of alarms, and have the effect of graded warning.

作為本發明的進一步改進，所述圍繞部設有一開口，該圍繞部的兩個末端部分別朝向該開口延伸設置兩個延伸區塊，所述延伸區塊用於增加局部漏液偵測區域，減少偵測死角。As a further improvement of the present invention, the surrounding portion is provided with an opening, and two end portions of the surrounding portion respectively extend toward the opening to provide two extension blocks, the extension blocks are used to increase the local leakage detection area, Reduce the detection of dead ends.

作為本發明的另一種改進，所述皮上感測器可包括一檢測電路，置於所述圍繞部的上表面並向所述連接部延伸，具有第A電極導線與第B電極導線，所述第A與第B電極導線間隔一段距離；所述警示模組，分別與所述第A及第B電極導線電性連接，不同的情況發生時，所述電極導線之間的等效電阻值會不同。當漏液未發生時，所述等效電阻值為100K~500K歐姆；當漏液發生時，所述第A與第B電極導線的阻抗變化異常，接近短路，所述等效電阻值為0K~50K歐姆；當所述生命體徵感測組件自體表脫落時，所述等效電阻值接近無限大，因此所述警示模組可根據不同的等效電阻值，觸發不同的警示級別，提醒相關人員進行相應的處理。As another improvement of the present invention, the on-skin sensor may include a detection circuit, which is placed on the upper surface of the surrounding portion and extends toward the connecting portion, and has an A-th electrode lead wire and a B-th electrode lead wire, so The A and B electrode wires are separated by a distance; the warning module is electrically connected to the A and B electrode wires respectively. When different situations occur, the equivalent resistance between the electrode wires Will be different. When leakage does not occur, the equivalent resistance value is 100K~500K ohms; when leakage occurs, the impedance change of the A and B electrode wires is abnormal, close to a short circuit, and the equivalent resistance value is 0K ~50K ohms; when the vital sign sensing component falls off the body surface, the equivalent resistance value is close to infinity, so the warning module can trigger different warning levels according to different equivalent resistance values to remind Relevant personnel will deal with it accordingly.

所述生命體徵感測組件還可進一步包括一皮下感測器，設置於所述基板的下表面，該皮下感測器包括至少一個發射模組與一檢測模組；所述發射模組發射訊號後，經由皮下血管吸收及反射，反射之訊號會由檢測模組進行感測，從而可用於偵測皮下的生命體徵數據。The vital sign sensing assembly may further include a subcutaneous sensor disposed on the lower surface of the substrate. The subcutaneous sensor includes at least one transmitting module and a detecting module; the transmitting module transmits signals Afterwards, through subcutaneous blood vessel absorption and reflection, the reflected signal will be sensed by the detection module, which can be used to detect subcutaneous vital signs data.

根據所述皮下感測器所偵測到的生命體徵數據，並計算該患 者的生命體徵數據變化值，當該患者的生命體徵數據變化值達到不同程度的預定閾值時，觸發不同的警示級別。According to the vital sign data detected by the subcutaneous sensor, the patient's vital sign data change value is calculated, and when the patient's vital sign data change value reaches different predetermined thresholds, different warning levels are triggered.

本發明之功效：透過該生命體徵感測組件的檢測及該監控系統，所述生命體徵感測系統能夠較全面地監測患者的皮上及皮下生命體徵狀態，在漏液或該生命體徵感測組件脫落時，能觸發不同的警示級別以及時反映患者的情況，讓醫護人員可依照報警級別及時進行對應的處理，提高醫療效率。The efficacy of the present invention: through the detection of the vital signs sensing component and the monitoring system, the vital signs sensing system can more comprehensively monitor the patient's superficial and subcutaneous vital signs status, and detect fluid leakage or vital signs When the component falls off, different warning levels can be triggered to reflect the patient's situation in time, so that the medical staff can perform corresponding treatment in time according to the alarm level, improving medical efficiency.

10‧‧‧手臂10‧‧‧arm

101‧‧‧表皮101‧‧‧Skin

102‧‧‧皮下血管102‧‧‧Subcutaneous vessels

11‧‧‧接觸區域11‧‧‧ contact area

20‧‧‧針具20‧‧‧Needle

30‧‧‧生命體徵感測組件30‧‧‧ Vital sign sensing component

31‧‧‧基板31‧‧‧ substrate

31a‧‧‧延伸區塊31a‧‧‧Extended block

31b‧‧‧延伸區塊31b‧‧‧Extended block

311‧‧‧圍繞部311‧‧‧ Surrounding Department

312‧‧‧翼片部312‧‧‧Flap

32‧‧‧漏液檢測電路32‧‧‧Leak detection circuit

321‧‧‧第一電極導線321‧‧‧First electrode lead

322‧‧‧第二電極導線322‧‧‧Second electrode lead

323‧‧‧第三電極導線323‧‧‧The third electrode lead

324‧‧‧第四電極導線324‧‧‧The fourth electrode lead

325‧‧‧第五電極導線325‧‧‧ fifth electrode lead

33‧‧‧連接部33‧‧‧ Connection

40‧‧‧開口40‧‧‧ opening

50‧‧‧皮下感測器50‧‧‧Subcutaneous sensor

51‧‧‧發射模組51‧‧‧ Launch Module

52‧‧‧檢測模組52‧‧‧Detection module

60‧‧‧固定組件60‧‧‧Fixed components

61‧‧‧隆起部61‧‧‧Bulge

62‧‧‧側翼部62‧‧‧flank

70‧‧‧監控系統70‧‧‧Monitoring system

71‧‧‧警示模組71‧‧‧Alarm module

72‧‧‧信號傳輸模組72‧‧‧Signal transmission module

第1圖為根據本發明實施例所述的用於醫療器械的生命體徵監測系統的使用情境示意圖。FIG. 1 is a schematic diagram of a usage situation of a vital sign monitoring system for medical devices according to an embodiment of the present invention.

第2圖為根據本發明實施例所述的生命體徵感測組件的使用情境示意圖。FIG. 2 is a schematic diagram of a usage situation of a vital sign sensing component according to an embodiment of the present invention.

第3圖為根據本發明實施例所述的生命體徵感測組件的示意圖。FIG. 3 is a schematic diagram of a vital sign sensing component according to an embodiment of the present invention.

第4圖為根據本發明實施例所述的漏液檢測電路示意圖。Figure 4 is a schematic diagram of a liquid leakage detection circuit according to an embodiment of the present invention.

第5圖為根據本發明另一實施例所述的漏液檢測電路示意圖。FIG. 5 is a schematic diagram of a liquid leakage detection circuit according to another embodiment of the present invention.

第6圖為根據本發明又一實施例所述的漏液檢測電路示意圖。FIG. 6 is a schematic diagram of a liquid leakage detection circuit according to another embodiment of the present invention.

第7圖為根據本發明實施例所述的漏液檢測電路局部細節示意圖。FIG. 7 is a partial detail schematic diagram of a liquid leakage detection circuit according to an embodiment of the present invention.

第8圖為根據本發明實施例所述的漏液檢測電路細節示意 圖。Fig. 8 is a schematic diagram of details of a liquid leakage detection circuit according to an embodiment of the present invention.

第9圖為根據本發明實施例所述的生命體徵感測組件的另一實施例及所述的漏液檢測電路示意圖。9 is a schematic diagram of another embodiment of the vital signs sensing assembly according to the embodiment of the present invention and the leakage detection circuit.

第10圖為根據本發明實施例所述的生命體徵感測組件的又一實施例及所述的漏液檢測電路示意圖。FIG. 10 is a schematic diagram of another embodiment of the vital signs sensing assembly according to the embodiment of the present invention and the leakage detection circuit.

第11圖為根據本發明實施例所述的生命體徵感測組件的皮下感測器的示意圖。FIG. 11 is a schematic diagram of a subcutaneous sensor of a vital sign sensing assembly according to an embodiment of the present invention.

第12圖為根據本發明實施例所述的生命體徵感測組件的皮下感測器的運作示意圖。FIG. 12 is a schematic diagram of the operation of the subcutaneous sensor of the vital sign sensing assembly according to the embodiment of the invention.

第13圖為根據本發明實施例所述的生命體徵感測組件與固定組件的示意圖。FIG. 13 is a schematic diagram of a vital sign sensing assembly and a fixing assembly according to an embodiment of the invention.

為更進一步闡述本發明為達成預定發明目的所採取的技術手段及功效，下面將結合附圖，通過多個實施例對本發明的技術方案進行詳細說明。多個實施例之間，對於相同或近似部件及方法步驟的實現方式、工作原理以及有益效果等，是可以相互參考和引用的，出於篇幅考慮，可能不會在每個實施例中都進行詳細的陳述，在此事先陳明。In order to further illustrate the technical means and effects adopted by the present invention to achieve the intended purpose of the invention, the technical solution of the present invention will be described in detail through multiple embodiments in conjunction with the accompanying drawings. Among multiple embodiments, the implementation methods, working principles, and beneficial effects of the same or similar components and method steps may be mutually referenced and cited. For space considerations, it may not be performed in each embodiment Detailed statements are presented here in advance.

本發明實施例首先提供一種用於醫療器械的生命體徵監測系統的使用情境示意圖。如第1圖所示，一生命體徵感測組件30與監控系統70配置在患者的手臂上，持續監控患者的生命體徵狀態，並透過數據傳輸將生命體徵數據傳輸至一閘道器80整合，並擁有一終端監控裝置90將資訊呈現給相關人員。The embodiment of the present invention first provides a schematic diagram of a usage situation of a vital sign monitoring system for medical devices. As shown in FIG. 1, a vitalsign sensing component 30 and amonitoring system 70 are disposed on the patient's arm, continuously monitor the vital sign state of the patient, and transmit the vital sign data to agateway 80 for integration through data transmission. And has aterminal monitoring device 90 to present information to relevant personnel.

第1圖所示僅為本發明實施方式之一，實際應用並不限於與此，例如，該閘道器可同時接收數個所述生命體徵監測系統所傳輸的生命體徵數據，此外，該閘道器可具有一配對系統，該配對系統可將數個床位的生命體徵監測系統的數據整合成醫護人員方便掌握與了解的顯示畫面達成多床監控的效果與提升醫療監控效率。例如，可以針對多床個別監控，或是一床多個生命體徵感測組件的監控。Figure 1 is only one of the embodiments of the present invention, and the actual application is not limited to this. For example, the gateway can simultaneously receive vital sign data transmitted by several vital sign monitoring systems. In addition, the gate The device can have a matching system, which can integrate the data of the vital signs monitoring system of several beds into a display screen that medical staff can easily grasp and understand to achieve the effect of multi-bed monitoring and improve the efficiency of medical monitoring. For example, multiple beds can be individually monitored, or multiple vital signs sensing components in one bed can be monitored.

所述監控終端裝置90可以為一顯示裝置，如電腦、筆電、平板以及手機等，但不限於此，方便醫護人員做監控。The monitoringterminal device 90 may be a display device, such as a computer, a laptop, a tablet, a mobile phone, etc., but it is not limited to this, and it is convenient for medical personnel to perform monitoring.

以醫療針具為例，如第2圖所示，在輸液或透析時，針具20一般紮在手臂10的內側，由此形成一個針具與皮膚的接觸區域11。該接觸區域的範圍不以第2圖為限，實際使用中可以根據不同的技術需要，以及醫療器械與皮膚的接觸方式而擴大或縮小。而圍繞所述接觸區域11而設置的則是本發明實施例所述的生命體徵感測組件30。Taking a medical needle as an example, as shown in FIG. 2, during infusion or dialysis, theneedle 20 is generally tied inside thearm 10, thereby forming acontact area 11 between the needle and the skin. The range of the contact area is not limited to the second image. In actual use, it can be expanded or reduced according to different technical needs and the way of contact between the medical device and the skin. The vitalsigns sensing assembly 30 described in the embodiment of the present invention is disposed around thecontact area 11.

如第3圖所示，根據本發明實施例所述的生命體徵感測組件30，位於接觸區域11附近，可以包括一基板31及一皮上感測器；其中，所述基板31具有一圍繞部311與一連接部33，所述圍繞部311用於圍繞並暴露出所述醫療器械與皮膚的接觸區域11；所述漏液檢測電路32置於所述基板31的上表面，至少包括第一電極導線321、第二電極導線322與第三電極導線323，所述第一、第二與第三電極導線間隔一段距離，在被液體跨接時接近短路。As shown in FIG. 3, the vitalsign sensing assembly 30 according to an embodiment of the present invention is located near thecontact area 11, and may include asubstrate 31 and an on-skin sensor; wherein, thesubstrate 31 has a surrounding Aportion 311 and a connectingportion 33, the surroundingportion 311 is used to surround and expose thecontact area 11 of the medical device with the skin; theleakage detection circuit 32 is placed on the upper surface of thesubstrate 31, at least including Anelectrode lead 321, asecond electrode lead 322, and athird electrode lead 323, the first, second, and third electrode leads are separated by a distance, and are close to a short circuit when being bridged by a liquid.

監控系統70包含一警示模組71與一信號傳輸模組72，所述警示模組71通過所述基板31的連接部33與所述基板31上不同電極導線分別電 性連接，或者通過其中一個導線延伸部與不同電極導線電性連接，並根據所述不同電極導線之間的短路導通情況產生警示信號。上述警示信號可直接透過一聲音警報元件在所述監控系統70上發出聲音警報；或是進一步由所述信號傳輸模組72傳輸到所述終端裝置90，在所述終端裝置90上發出警報。Themonitoring system 70 includes awarning module 71 and asignal transmission module 72. Thewarning module 71 is electrically connected to different electrode wires on thesubstrate 31 through theconnection portion 33 of thesubstrate 31, or through one of them The lead extension is electrically connected to different electrode leads, and generates a warning signal according to the short-circuit conduction between the different electrode leads. The above warning signal can directly send a sound alarm on themonitoring system 70 through a sound alarm element; or it can be further transmitted by thesignal transmission module 72 to theterminal device 90 to issue an alarm on theterminal device 90.

其中，所述圍繞部311設有一開口40，該圍繞部311的兩個末端部分別朝向該開口延伸設置兩個延伸區塊31a、31b，所述延伸區塊31a、31b用於增加局部漏液偵測區域，減少偵測死角。Wherein, the surroundingportion 311 is provided with anopening 40, and two end portions of the surroundingportion 311 are respectively extended toward the opening by two extendingblocks 31a, 31b, and the extendingblocks 31a, 31b are used to increase local leakage Detection area, reduce detection dead angle.

根據本發明的實施例，所述延伸區塊31a、31b為矩形，但也可為半圓形等不限於此。且所述延伸塊鄰近開口的一邊的長度大於2mm，靠近所述圍繞部311內側的一邊的長度大於1mm。According to the embodiment of the present invention, the extension blocks 31a and 31b are rectangular, but they may also be semi-circular and the like, which is not limited thereto. The length of the side of the extension block adjacent to the opening is greater than 2 mm, and the length of the side near the inner side of the surroundingportion 311 is greater than 1 mm.

其中，所述生命體徵感測組件偵測到的生命體徵數據透過所述信號傳輸模組72進行數據傳輸，所述信號傳輸模組72可以為有線傳輸模組或無線傳輸模組，無線傳輸模組可以為Zigbee、Bluetooth或Wi-Fi等，但不限於此。有線傳輸具有穩定傳輸的功能，而無線傳輸可以使裝置與裝置之間有足夠的活動度，但亦可能受限於外在環境的干擾而傳輸功能欠佳，可以依據環境與資源做適切的調整。Wherein, the vital signs data detected by the vital signs sensing component performs data transmission through thesignal transmission module 72. Thesignal transmission module 72 may be a wired transmission module or a wireless transmission module. The group may be Zigbee, Bluetooth, Wi-Fi, etc., but is not limited thereto. Wired transmission has the function of stable transmission, while wireless transmission can allow sufficient activity between devices, but it may also be limited by the interference of the external environment and the transmission function is not good. It can be adjusted according to the environment and resources. .

第3圖所示僅為本發明實施方式之一，實際應用並不限於與此，例如，監控系統70可以為漏液檢測電路32供電，並可以根據不同電極導線之間是短路還是斷路，以及發生短路或斷路的電極導線的組合等情況，觸發不同的警示級別，但是監控系統70與基板31及漏液檢測電路32的結合，可以透過基板31的連接部33一體連接，也可以是分體連接，當分體 連接時，基板31及漏液檢測電路32即可單獨構成一個生命體徵感測組件30，獨立售賣，再與監控系統70結合後，即可應用於臨床。如此，即便基板31污損後，監控系統70仍可重複使用，節省了總體成本。FIG. 3 is only one of the embodiments of the present invention, and the actual application is not limited to this. For example, themonitoring system 70 may supply power to theleakage detection circuit 32, and may be short-circuited or open-circuited between different electrode wires, and The combination of the electrode leads that are short-circuited or broken triggers different warning levels, but the combination of themonitoring system 70 and thesubstrate 31 and theleakage detection circuit 32 can be integrally connected through theconnection portion 33 of thesubstrate 31 or can be separate When connected separately, thesubstrate 31 and theleakage detection circuit 32 can separately constitute a vitalsign sensing component 30, which is sold separately, and then combined with themonitoring system 70, which can be used in the clinic. In this way, even after thesubstrate 31 is contaminated, themonitoring system 70 can be reused, saving the overall cost.

具體而言，如第3圖所示，所述漏液檢測電路32中，第一電極導線321與所述第二及第三電極導線間隔一段距離，並在被液體跨接時與第二和/或第三電極導線接近短路；而所述警示模組71，與所述第一電極導線321、第二電極導線322與第三電極導線323電性連接，當所述第一電極導線321與第二電極導線322和/或第三電極導線323短路時，觸發警示。由於不同電極導線之間的距離和位置是預知的，因此，可根據不同電極導線之間的短路情況感知到漏液的多寡以及漫延的面積，如第一電極導線321與第二電極導線322短路時，觸發一級警示，而當第二電極導線322與第三電極導線323短路時，觸發二級警示，由於第三電極導線323的位置更靠近外沿，說明漏液程度更高，漫延的面積增大，因此，二級警示的級別高於一級警示的級別。Specifically, as shown in FIG. 3, in the liquidleakage detection circuit 32, thefirst electrode lead 321 is separated from the second and third electrode leads by a distance, and is connected to the second and /Or the third electrode lead is close to short circuit; and thewarning module 71 is electrically connected to thefirst electrode lead 321, thesecond electrode lead 322, and thethird electrode lead 323, when thefirst electrode lead 321 is When thesecond electrode lead 322 and/or thethird electrode lead 323 is short-circuited, an alarm is triggered. Since the distance and position between the different electrode wires are predictable, the amount of leakage and the spread area can be detected according to the short circuit between the different electrode wires, such as the short circuit of thefirst electrode wire 321 and thesecond electrode wire 322 When thesecond electrode lead 322 and thethird electrode lead 323 are short-circuited, the second alert is triggered. The position of thethird electrode lead 323 is closer to the outer edge, indicating a higher level of leakage and spreading area. Increase, therefore, the level of the second warning is higher than the level of the first warning.

上述第一電極導線321、第二電極導線322與第三電極導線323的分佈形態不以第3圖為限，也可以是其他分佈形態，例如第4圖所示，為另一種不同電極導線的分佈形態，第二電極導線322和第三電極導線323與第一電極導線321的距離相同，但位置相對，這樣，當第一電極導線321與第二電極導線322或第三電極導線323短路時，觸發一級警示，而當第一電極導線321與第二電極導線322及第三電極導線323都發生短路時，觸發二級警示。短路點越多，說明漏液漫延面積越大，因此警示級別也越高。The distribution patterns of thefirst electrode lead 321, thesecond electrode lead 322 and thethird electrode lead 323 are not limited to FIG. 3, but may be other distribution patterns, for example, as shown in FIG. 4, it is a different electrode lead Distribution pattern, the distance between thesecond electrode lead 322 and thethird electrode lead 323 is the same as thefirst electrode lead 321, but the positions are opposite, so that when thefirst electrode lead 321 is short-circuited with thesecond electrode lead 322 or thethird electrode lead 323 , Trigger a first-level warning, and when thefirst electrode lead 321 and thesecond electrode lead 322 and thethird electrode lead 323 are short-circuited, trigger a second alert. The more short-circuit points, the larger the leakage area, so the warning level is also higher.

根據本發明的另一實施例，除了第3圖所述第一、第二與第 三電極導線以外，還可以進一步包括第四電極導線324與第五電極導線325(中間電極導線)，如第5圖所示。所述不同電極導線之間間隔一段距離，並在被液體跨接時接近短路；而所述警示模組71，與所述第一電極導線321電性連接，當所述第一電極導線321和/或第二電極導線322、第三電極導線323、第四電極導線324及第五電極導線短路325時，觸發警示。由於不同電極導線之間的距離和位置是預知的，因此，可根據不同電極導線之間的短路情況感知到漏液的多寡以及漫延的面積，如第一電極導線321與第四電極導線324或第五電極導線325短路時，觸發一級警示，而當第一電極導線321與第三電極導線323或第二電極導線322短路時，觸發三級警示；由於第二電極導線322與第三電極導線323的位置更靠近外沿，表示漏液程度更高，漫延的面積增大，因此，警示級別也越高。According to another embodiment of the present invention, in addition to the first, second, and third electrode wires described in FIG. 3, afourth electrode wire 324 and a fifth electrode wire 325 (intermediate electrode wire) may be further included, as Figure 5 shows. The different electrode wires are separated by a certain distance, and are close to a short circuit when being bridged by liquid; and thewarning module 71 is electrically connected to thefirst electrode wire 321, when thefirst electrode wire 321 and /Or when thesecond electrode lead 322, thethird electrode lead 323, thefourth electrode lead 324, and the fifth electrode lead short 325, an alarm is triggered. Since the distance and position between different electrode wires are predictable, the amount of leakage and the spread area can be detected according to the short circuit between different electrode wires, such as thefirst electrode wire 321 and thefourth electrode wire 324 or When thefifth electrode lead 325 is short-circuited, a first-level warning is triggered, and when thefirst electrode lead 321 is short-circuited with thethird electrode lead 323 or thesecond electrode lead 322, a third-level alert is triggered; because thesecond electrode lead 322 and the third electrode lead The position of 323 is closer to the outer edge, indicating a higher level of liquid leakage and an increase in the spread area. Therefore, the warning level is also higher.

其中，所述電極導線間隔距離大於0.05mm。Wherein, the distance between the electrode wires is greater than 0.05mm.

當漏液檢測電路中分佈的不同電極導線越多時，其可形成的檢測區域也越多，對漏液多寡的檢測也就越精確，警示級別也可相應的調整。When there are more different electrode wires distributed in the leakage detection circuit, the more detection areas it can form, the more accurate the detection of the amount of leakage, and the warning level can also be adjusted accordingly.

為進一步增加檢測的敏感度，一方面可以減小各個電極導線之間的距離，另一方面，還可以對電極導線的具體形態進行設計，以增加電極導線分佈的密度，例如，可以在漏液檢測電路不同的電極導線之間設計至少一個交織感測區域，在所述交織感測區域，所述不同電極導線形成緊密相臨的交錯形狀。In order to further increase the sensitivity of detection, on the one hand, the distance between each electrode lead can be reduced, on the other hand, the specific shape of the electrode lead can also be designed to increase the density of the electrode lead distribution, for example, it can leak At least one interweaving sensing area is designed between different electrode wires of the detection circuit, and in the interweaving sensing area, the different electrode wires form closely interleaved shapes.

如第6圖所示，即為在不同電極導線321及322之間設置至少一個交織感測區域326，最好是按照圍繞形態平均分佈多個交織感測區域， 在所述交織感測區域326，所述不同電極導線形成緊密相臨的交錯形狀。當漏液流經第一電極導線321，但還未流到第三電極導線322之前，如果沒有交織感測區域326，則不會觸發短路警示，但如果恰好流經交織感測區域326時，即可立刻發生短路警示。如果進一步增加交織感測區域的分佈數量，則可進一步強化靈敏度。As shown in FIG. 6, at least one interweavingsensing area 326 is provided betweendifferent electrode wires 321 and 322, preferably, a plurality of interweaving sensing areas are evenly distributed according to the surrounding shape. In the interweavingsensing area 326 , The different electrode wires form closely interleaved shapes. When the leaked liquid flows through thefirst electrode lead 321, but not before thethird electrode lead 322, if there is no interlacedsensing area 326, the short circuit warning will not be triggered, but if it happens to flow through the interlacedsensing area 326, A short circuit warning can occur immediately. If the distribution number of the interlaced sensing area is further increased, the sensitivity can be further strengthened.

而當漏液檢測電路32中除第一電極導線321、第二電極導線322與第三電極導線323外還包括多個中間電極導線時，通過在兩兩電極導線之間設計交織感測區域即可形成不同電極導線之間的多點檢測，警示模組71可根據發生短路導通的電極導線的數量和/或位置，感知到漏液的多寡以及漏液的面積，由此可觸發不同的警示級別。When theleakage detection circuit 32 includes a plurality of intermediate electrode leads in addition to thefirst electrode lead 321, thesecond electrode lead 322, and thethird electrode lead 323, by designing an interweaving sensing area between the two electrode leads Multi-point detection between different electrode wires can be formed, and thewarning module 71 can detect the amount of leakage and the area of the leakage according to the number and/or position of the short-circuited electrode wires, thus triggering different warnings level.

舉例來說，如第7圖所示，第一電極導線321與其餘電極導線之間分別設計至少一個交織感測區域326，在所述交織感測區域326中，所述不同電極導線形成緊密相臨的交錯形狀。如此，由於其餘電極導線與第一電極導線321之間具有距離與位置的對應性，因此，所述警示模組根據發生短路導通的電極導線的位置和/或數量，觸發不同的警示級別。For example, as shown in FIG. 7, at least one interweavingsensing area 326 is designed between thefirst electrode wire 321 and the remaining electrode wires, in which the different electrode wires form a close phase Pro interlaced shape. In this way, since the remaining electrode wires and thefirst electrode wires 321 have a correspondence between the distance and the position, the warning module triggers different warning levels according to the position and/or number of the electrode wires that are short-circuited.

本發明實施例所述基板31為柔性基板，以便使基板與體表的形態相適應，使所述生命體徵感測組件30更加服帖的貼附於體表區域；所述基板31的材料為聚亞醯胺或聚對苯二甲酸乙二酯。In the embodiment of the present invention, thesubstrate 31 is a flexible substrate, so as to adapt the substrate to the shape of the body surface, so that the vitalsign sensing component 30 is more closely attached to the body surface area; the material of thesubstrate 31 is poly Acetamide or polyethylene terephthalate.

所述基板31下表面可以具有粘貼材料層，使所述生命體徵感測組件30以貼片形狀直接貼附於體表區域。The lower surface of thesubstrate 31 may have an adhesive material layer, so that the vitalsign sensing component 30 is directly attached to the body surface area in a patch shape.

此外，根據本發明的實施例，所述生命體徵感測組件30還可以進一步包括一膠帶層，所述基板31及漏液檢測電路32置於所述膠帶層上 表面，而在所述膠帶層下表面具有粘貼材料層。In addition, according to the embodiment of the present invention, the vitalsign sensing assembly 30 may further include a tape layer, thesubstrate 31 and theleakage detection circuit 32 are placed on the upper surface of the tape layer, and the tape layer The lower surface has a layer of adhesive material.

所述膠帶層的至少一側端可具有易撕部，與另一生命體徵感測組件30的膠帶層一側端連接，形成連續結構。如此，可方便儲存及使用。At least one end of the tape layer may have an easy-to-tear portion, which is connected to one side end of the tape layer of another vitalsign sensing assembly 30 to form a continuous structure. In this way, it can be conveniently stored and used.

此外，根據本發明的實施例，所述生命體徵感測組件30還可以進一步包括一覆蓋層，覆於所述基板及漏液檢測電路上方；所述覆蓋層可以為滲透材料層，例如紗布、繃帶等醫療輔助材料。In addition, according to the embodiment of the present invention, the vitalsign sensing assembly 30 may further include a covering layer overlying the substrate and the leakage detection circuit; the covering layer may be a permeable material layer, such as gauze, Medical auxiliary materials such as bandages.

根據本發明的另一實施例，所述基板31可為一滲透材料透過導線與所述警示模組71電性連接。所述滲透材料，例如：紗布、棉墊等，用於吸收滲漏的液體；所述漏液檢測電路30的電極導線材料為銅箔、銀漿或金屬化纖維中的一種或多種。當基板採用滲透材料時，可加速漏液的吸收，而紗布、棉墊等滲透材料為護理人員接受度高的醫療產品，而護理人員在協助患者進行血液透析時，會需要使用紗布，加上金屬針織技術的結合應用，使得紗布本身即可偵測脫針漏血的情況，將可提升醫療品質以及減輕護理人員的負擔。此外，亦可將上述紗布嵌入一RFID標籤，當漏液發生時，該RFID標籤收到不同的電訊號並以天線回傳給一RFID讀取器(如其他實施例所述之信號傳輸模組)。如此一來該紗布與該RFID讀取器可分開放置，例如該紗布放置於患者手臂，該RFID讀取器放置於患者床邊，當所述RFID讀取器收到漏液信號後發出警示，同時也可透過無線網路傳輸到終端裝置上發出警示。According to another embodiment of the present invention, thesubstrate 31 may be a permeable material electrically connected to thewarning module 71 through a wire. The permeable material, for example, gauze, cotton pads, etc., is used to absorb the leaked liquid; the electrode lead material of theleak detection circuit 30 is one or more of copper foil, silver paste, or metalized fiber. When the penetration material is used for the substrate, the absorption of liquid leakage can be accelerated, and the penetration materials such as gauze and cotton pads are medical products with high acceptance by the nursing staff, and the nursing staff will need to use the gauze when assisting the patient in hemodialysis, plus The combined application of metal knitting technology makes the gauze itself detect the loss of needle and blood leakage, which will improve the medical quality and reduce the burden on nursing staff. In addition, the above-mentioned gauze can also be embedded in an RFID tag. When leakage occurs, the RFID tag receives different electrical signals and transmits it back to an RFID reader via an antenna (such as the signal transmission module described in other embodiments) ). In this way, the gauze and the RFID reader can be placed separately, for example, the gauze is placed on the patient's arm, and the RFID reader is placed beside the patient's bed. When the RFID reader receives a leakage signal, it issues a warning. At the same time, it can be transmitted to the terminal device through the wireless network to issue a warning.

在本發明的另一實施例中，所述基板31還可以進一步包括至少一個自該圍繞部311往外延伸並用以貼抵於患者體表的可撓曲的翼片部312，如第8圖所示，所述基板31具有兩個翼片部312，方便護理人員將所述 生命體徵感測組件30依患者的手臂或生理結構情況調整，以更加服貼於患者的體表，並可降低患者的晃動而導致所述生命體徵感測組件30的偏移。本實施例中所述的漏液檢測電路32可與上述實施例相同，例如第3圖至第7圖中所述的漏液檢測電路，在此不再贅述。In another embodiment of the present invention, thebase plate 31 may further include at least oneflexible fin portion 312 extending outward from the surroundingportion 311 and used to bear against the surface of the patient, as shown in FIG. 8 It is shown that thebase plate 31 has twowing parts 312, so that the nursing staff can adjust the vitalsign sensing component 30 according to the patient's arm or physiological structure, so as to be more suitable for the patient's body surface, and can reduce the patient The sway causes a deviation of the vitalsign sensing assembly 30. The liquidleakage detection circuit 32 described in this embodiment may be the same as the above embodiment. For example, the liquid leakage detection circuit described in FIGS. 3 to 7 will not be repeated here.

此外，所述基板31的圍繞部311、延伸區塊31a、31b與翼片部312的一側也可以切齊為一直線，如第9圖所示，將所述基板的圍繞部311與翼片部312的一側做切齊處理，可減少基板對蝴蝶針具的干擾，其中，所述基板31的延伸區塊31a、31b的面積雖有減少，但可藉由改變電極導線的配置，仍可保有局部的漏液偵測區域，減少偵測死角；本實施例中所述的漏液檢測電路可與上述實施例相同，例如第3圖至第7圖中所述的漏液檢測電路，但不限於此。In addition, the surroundingportion 311 of thesubstrate 31, the extension blocks 31a, 31b and one side of thefin portion 312 may also be cut into a straight line, as shown in FIG. 9, the surroundingportion 311 of the substrate and the fin The side of theportion 312 is aligned to reduce the interference of the substrate to the butterfly needle. Although the area of the extension blocks 31a and 31b of thesubstrate 31 is reduced, it can still be changed by changing the configuration of the electrode lead. Local leakage detection area can be kept to reduce the detection dead angle; the leakage detection circuit described in this embodiment can be the same as the above embodiment, for example, the leakage detection circuit described in FIGS. 3 to 7, But it is not limited to this.

根據本發明的又一實施例，所述基板31的連接部33可沿著所述圍繞部311的外沿向外延伸，如第10圖所示，該連接部33從靠近所述圍繞部311的左側末端處向外延伸，該連接部33也可從靠近所述圍繞部311的右側末端處向外延伸；藉由不同的基板形狀設計，可依患者的手臂或生理結構情況，調整所述生命體徵感測組件30與所述監控系統70結合時的相對位置。According to yet another embodiment of the present invention, the connectingportion 33 of thesubstrate 31 may extend outward along the outer edge of the surroundingportion 311, as shown in FIG. 10, the connectingportion 33 approaches the surroundingportion 311 from The left end of the left side extends outward, and the connectingportion 33 can also extend outward from the right end near the surroundingportion 311; by different substrate shape designs, the patient can be adjusted according to the patient’s arm or physiological structure The relative position of the vitalsigns sensing component 30 when combined with themonitoring system 70.

為防止所述生命體徵感測組件30從體表脫落，根據本發明的另一實施例，所述皮上感測器包括一檢測電路，置於所述圍繞部31的上表面並向所述連接部33延伸，具有第A電極導線與第B電極導線，所述第A與第B電極導線間隔一段距離；所述監控系統70的警示模組71分別與所述第A及第B電極導線電性連接，根據所述電極導線之間的不同的等效電阻值，觸 發不同的警示級別；其中，當漏液未發生時，所述等效電阻值為100K~500K歐姆，當漏液發生時，所述第A與第B電極導線接近短路，所述等效電阻值為0K~50K歐姆，當所述生命體徵感測組件自體表脫落時，所述等效電阻值接近無限大。In order to prevent the vitalsigns sensing assembly 30 from falling off from the body surface, according to another embodiment of the present invention, the on-skin sensor includes a detection circuit placed on the upper surface of the surroundingportion 31 and facing theThe connecting portion 33 extends, and has an A-th electrode lead and a B-th electrode lead, the A-th and B-th electrode leads are separated by a distance; thewarning module 71 of themonitoring system 70 is respectively separated from the A- and B-th electrode leads Electrical connection, according to different equivalent resistance values between the electrode wires, trigger different warning levels; where, when leakage does not occur, the equivalent resistance value is 100K ~ 500K ohms, when leakage occurs At this time, the lead wires of the A and B electrodes are nearly short-circuited, and the equivalent resistance value is 0K to 50K ohms. When the vital sign sensing component is detached from the body surface, the equivalent resistance value is close to infinity.

在本發明實施例中，所述警示模組71可通過導電夾鉗和/或插針與不同的電極導線之間可分離式的電性連接。In the embodiment of the present invention, thewarning module 71 may be detachably electrically connected to different electrode wires through conductive clamps and/or pins.

此外，為了偵測患者皮下的生命體徵情況，所述生命體徵感測組件還可以包括有一皮下感測器50，設置於所述基板的下表面，如第11圖所示；所述皮下感測器包括至少一個發射模組51與一檢測模組52，所述發射模組51發射訊號後，訊號會穿過表皮101經由皮下血管102吸收及反射，反射之訊號會由檢測模組52進行感測，如第12圖所示；例如，皮下感測器50可包括第一發射模組、第二發射模組與一檢測模組，第一發射模組發射的訊號用於偵測是否有漏血，血管破損漏血與正常狀態，使訊號反射強度不同，而第二發射模組發射的訊號做為輔助校正。In addition, in order to detect the patient's subcutaneous vital signs, the vital sign sensing assembly may further include asubcutaneous sensor 50, which is disposed on the lower surface of the substrate, as shown in FIG. 11; the subcutaneous sensing The transmitter includes at least onetransmission module 51 and adetection module 52. After thetransmission module 51 transmits a signal, the signal will be absorbed and reflected through thesubcutaneous blood vessel 102 through theepidermis 101, and the reflected signal will be sensed by thedetection module 52 As shown in FIG. 12; for example, thesubcutaneous sensor 50 may include a first transmitting module, a second transmitting module, and a detection module. The signal transmitted by the first transmitting module is used to detect whether there is a leak Blood and blood vessels are damaged and leaked, and the normal state makes the signal reflection intensity different, and the signal transmitted by the second transmitting module is used as an auxiliary correction.

為了使醫療器械更加服帖，根據本發明的實施例，所述生命體徵感測組件30還可以包括一固定組件60，用於將所述醫療器械服帖固定於所述接觸區域11，如第13圖所示；所述固定組件60下表面可通過粘性材料層或紗布等輔料固定於體表區域。In order to make the medical device more compliant, according to the embodiment of the present invention, the vitalsign sensing assembly 30 may further include a fixingassembly 60 for affixing the medical device to thecontact area 11, as shown in FIG. 13 As shown; the lower surface of the fixingcomponent 60 can be fixed to the body surface area through an adhesive material layer or gauze and other auxiliary materials.

根據本發明的另一實施例，所述固定組件60可以與所述基板31相結合，用於將所述醫療器械服帖固定於所述接觸區域11，如第13圖所述固定組件60可以包括：隆起部61，用於容納並夾持所述醫療器械20從所述隆起部61穿過；側翼部62，從所述隆起部61兩側向外延伸形成，由柔性 材料製成，用於通過所述側翼部62操作所述醫療器械；所述兩個側翼部62下表面分別具有一感應電極導線，當操作所述側翼部62並使所述兩個感應電極導線相接觸時接近短路；而所述監控系統70的警示模組71，可分別與所述兩個感應電極導線電性連接，當所述兩個感應電極導線短路後又發生斷路時，觸發警示。According to another embodiment of the present invention, the fixingassembly 60 may be combined with thesubstrate 31 to fix the medical device to thecontact area 11, as shown in FIG. 13, the fixingassembly 60 may include : A raisedportion 61 for accommodating and holding themedical device 20 through the raisedportion 61; aside wing portion 62, formed to extend outward from both sides of the raisedportion 61, made of a flexible material, used for The medical device is operated through theside wing portion 62; the lower surfaces of the twoside wing portions 62 each have an induction electrode wire, which is close to a short circuit when theside wing portion 62 is operated and the two induction electrode wires are brought into contact; Thewarning module 71 of themonitoring system 70 can be electrically connected to the two sensing electrode wires respectively. When the two sensing electrode wires are short-circuited and then open, a warning is triggered.

此外，本發明實施例所述的生命體徵感測組件30，還可以包括溫度、濕度、PH值、心律、血壓等體徵感測器，與所述警示模組71電性連接，根據與預置的體徵閾值的偏離情況，觸發警示。In addition, the vitalsign sensing assembly 30 according to the embodiment of the present invention may further include temperature, humidity, PH value, heart rhythm, blood pressure and other sign sensors, which are electrically connected to thewarning module 71 according to preset The deviation of the physical sign threshold triggers an alert.

本發明實施例所述的生命體徵感測組件30可以應用於動靜脈導管漏液、藥物注射漏液、手術動刀時靜脈漏液、重症監護之靜脈漏液、葉克膜管路皮上/皮下漏液等情況。The vitalsign sensing assembly 30 according to the embodiment of the present invention can be applied to arterial and venous catheter leakage, drug injection leakage, venous leakage during surgical knife operation, venous leakage in intensive care, and epithelial membrane of Yeke membrane tube. Leakage under the skin, etc.

【本代表圖之符號簡單說明】：[Simple description of symbols in this representative picture]:

30‧‧‧生命體徵感測組件30‧‧‧ Vital sign sensing component

70‧‧‧監控系統70‧‧‧Monitoring system

80‧‧‧閘道器80‧‧‧ Gateway

90‧‧‧終端監控裝置90‧‧‧terminal monitoring device

Claims (10)

Translated fromChinese

一種用於醫療器械的生命體徵監測系統，包括：一醫療器械；一生命體徵感測組件，包含一基板，所述基板具有一圍繞部與一連接部，且所述圍繞部用於圍繞並暴露出所述醫療器械與皮膚的接觸區域，以及；一監控系統，包含一警示模組與一信號傳輸模組，該警示模組電性連接於該生命體徵感測組件；其中，所述生命體徵感測組件用以偵測一患者的生命體徵數據並將所偵測的生命體徵數據傳送至所述警示模組；所述警示模組根據所述生命體徵數據變化情況，產生一警示信號，並透過所述信號傳輸模組將所述警示信號傳輸到一閘道器，用以收集所述警示信號並透過運算處理整合至一終端監控裝置。 A vital sign monitoring system for medical devices, including: a medical device; a vital sign sensing assembly, including a substrate, the substrate having a surrounding portion and a connecting portion, and the surrounding portion is used to surround and expose A contact area between the medical device and the skin, and; a monitoring system including a warning module and a signal transmission module, the warning module is electrically connected to the vital signs sensing component; wherein, the vital signs The sensing component is used to detect vital sign data of a patient and transmit the detected vital sign data to the warning module; the warning module generates a warning signal according to the change of the vital sign data, and The warning signal is transmitted to a gateway through the signal transmission module for collecting the warning signal and integrating into a terminal monitoring device through arithmetic processing. 如權利要求1所述的生命體徵監測系統，其特徵在於，所述生命體徵感測組件包括一皮上感測器，設置於所述基板的上表面，所述皮上感測器包括：一漏液檢測電路，置於所述圍繞部的上表面並向所述連接部延伸，至少包括第一電極導線、第二電極導線與第三電極導線，所述第一、第二與第三電極導線間隔一段距離，在被液體跨接時接近短路；其中，所述圍繞部設有一開口，該圍繞部的兩個末端部分別朝向該開口延伸設置兩個延伸區塊，所述延伸區塊用於增加局部漏液偵測區域，減少偵測死角。 The vital signs monitoring system according to claim 1, wherein the vital signs sensing component includes an on-skin sensor disposed on the upper surface of the substrate, the on-skin sensor includes: a A liquid leakage detection circuit is placed on the upper surface of the surrounding portion and extends toward the connection portion, and includes at least a first electrode lead, a second electrode lead and a third electrode lead, the first, second and third electrodes The wires are separated by a distance, and are close to a short circuit when they are bridged by liquid; wherein, the surrounding portion is provided with an opening, and two end portions of the surrounding portion are respectively extended toward the opening by two extension blocks, the extension blocks are used for To increase the local leakage detection area and reduce the detection dead angle. 如權利要求2所述的生命體徵監測系統，其特徵在於，所述警示模組通過所述基板的連接部與所述基板上不同的電極導線分別電性連接，並根據發生異常阻抗變化的電極導線數量和/或位置，觸發不同的警示級別。 The vital sign monitoring system according to claim 2, wherein the warning module is electrically connected to different electrode leads on the substrate through the connection portion of the substrate, and according to the electrode that changes in abnormal impedance The number and/or position of the wires trigger different warning levels. 如權利要求3所述的生命體徵監測系統，其特徵在於，所述基板包含一RFID標籤，所述不同的警示級別透過無線傳輸方式傳遞至所述信號傳輸模組。 The vital signs monitoring system according to claim 3, wherein the substrate includes an RFID tag, and the different warning levels are transmitted to the signal transmission module through wireless transmission. 警示模組如權利要求2所述的生命體徵監測系統，其特徵在於，所述生命體徵感測組件還包括有一皮下感測器，設置於所述基板的下表面，所 述皮下感測器包括至少一個發射模組與一檢測模組，用於偵測皮下的生命體徵數據；其中，所述發射模組發射訊號後，經由皮下血管吸收及反射，反射之訊號會由檢測模組進行感測。 The warning module as claimed in claim 2, wherein the vital signs monitoring system further comprises a subcutaneous sensor disposed on the lower surface of the substrate, the subcutaneous sensor includes At least one transmitting module and a detecting module for detecting subcutaneous vital signs data; wherein, after transmitting the signal, the transmitting module absorbs and reflects through subcutaneous blood vessels, and the reflected signal will be sensed by the detecting module . 如權利要求5所述的生命體徵監測系統，其特徵在於，所述警示模組根據所述皮下感測器所偵測到的生命體徵數據，並計算該患者的生命體徵數據變化值，當該患者的生命體徵數據變化值達到不同程度的預定閾值時，觸發不同的警示級別。 The vital sign monitoring system according to claim 5, wherein the warning module calculates the change value of the patient's vital sign data based on the vital sign data detected by the subcutaneous sensor when the When the change value of the patient's vital signs data reaches different predetermined thresholds, different warning levels are triggered. 如權利要求5所述的生命體徵監測系統，其特徵在於，所述基板為柔性基板，所述基板的下表面具有粘貼材料層；所述生命體徵感測組件進一步還包括覆蓋層，覆於所述基板及所述漏液檢測電路上方；所述覆蓋層為滲透材料層。 The vital signs monitoring system according to claim 5, wherein the substrate is a flexible substrate, and the lower surface of the substrate has a layer of adhesive material; the vital signs sensing assembly further includes a cover layer covering the substrate Above the substrate and the leakage detection circuit; the cover layer is a permeable material layer. 如權利要求1所述的生命體徵監測系統，其特徵在於，所述信號傳輸模組可以為有線傳輸模組或無線傳輸模組，不限於此；所述終端監控裝置可以為一顯示裝置，如電腦、筆電、平板以及手機等，不限於此。 The vital signs monitoring system according to claim 1, wherein the signal transmission module may be a wired transmission module or a wireless transmission module, which is not limited thereto; the terminal monitoring device may be a display device, such as Computers, laptops, tablets and mobile phones are not limited to this. 如權利要求1所述的生命體徵監測系統，其特徵在於，所述生命體徵感測組件包括一皮上感測器，設置於所述基板的上表面，所述皮上感測器包括：一檢測電路，置於所述圍繞部的上表面並向所述連接部延伸，具有第A電極導線與第B電極導線，所述第A與第B電極導線間隔一段距離；所述警示模組，分別與所述第A及第B電極導線電性連接，根據所述電極導線之間的不同的等效電阻值，觸發不同的警示級別；其中，當漏液未發生時，所述等效電阻值為100K~500K歐姆，當漏液發生時，所述第A與第B電極導線接近短路，所述等效電阻值為0K~50K歐姆，當所述生命體徵感測組件自體表脫落時，所述等效電阻值接近無限大。 The vital signs monitoring system according to claim 1, wherein the vital signs sensing component includes an on-skin sensor disposed on the upper surface of the substrate, the on-skin sensor includes: a The detection circuit is placed on the upper surface of the surrounding portion and extends toward the connection portion, and has an A-th electrode lead and a B-th electrode lead, the A-th and B-th electrode leads are separated by a distance; the warning module, Are electrically connected to the A and B electrode wires, respectively, and trigger different warning levels according to different equivalent resistance values between the electrode wires; wherein, when leakage does not occur, the equivalent resistance The value is 100K~500K ohms, when leakage occurs, the A and B electrode wires are close to short circuit, the equivalent resistance value is 0K~50K ohms, when the vital signs sensing component comes off from the body surface , The equivalent resistance value is close to infinity. 如權利要求9所述的生命體徵監測系統，其特徵在於，所述生命體徵感測組件還包括有一皮下感測器，設置於所述基板的下表面，所述皮下感測器包括至少一個發射模組與一檢測模組，用於偵測皮下的生命體徵數據；其中，所述發射模組發射訊號後，經由皮下血管吸收及反射，反射之訊號會由檢測模組進行感測。 The vital sign monitoring system according to claim 9, wherein the vital sign sensing assembly further includes a subcutaneous sensor disposed on the lower surface of the substrate, the subcutaneous sensor includes at least one transmitter A module and a detection module are used to detect subcutaneous vital signs data; wherein, after the transmission module emits a signal, it is absorbed and reflected by subcutaneous blood vessels, and the reflected signal will be sensed by the detection module.

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