TWI719792B - Physiological monitor - Google Patents
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Abstract
本發明係揭示一種生理監測器,包含封閉殼體、電路單元、保護套以及訊號量測貼片,可貼附於哺乳類動物的體表,用以連續感測並記錄哺乳類動物的生理訊號。尤其,訊號量測貼片包含上透濕層、至少二電極、至少二定位環、至少二導電水凝膠、基座以及下透濕層,其中上透濕層及下透濕層是相互結合以保護夾附在其中的元件,並由下透濕層底下的背膠貼附到體表而固定。由於上透濕層及下透濕層具高度的透濕性及透氣性,可避免引起不適感,非常適合長時間使用,大幅改善使用上的便利性。The present invention discloses a physiological monitor comprising a closed casing, a circuit unit, a protective cover and a signal measuring patch, which can be attached to the body surface of mammals to continuously sense and record the physiological signals of the mammals. In particular, the signal measurement patch includes an upper moisture-permeable layer, at least two electrodes, at least two positioning rings, at least two conductive hydrogels, a base, and a lower moisture-permeable layer, wherein the upper moisture-permeable layer and the lower moisture-permeable layer are combined with each other It protects the components attached to it, and is fixed by attaching the adhesive under the lower moisture-permeable layer to the body surface. Since the upper moisture permeable layer and the lower moisture permeable layer have high moisture permeability and air permeability, it can avoid causing discomfort, which is very suitable for long-term use and greatly improves the convenience of use.
Description
本發明係有關於一種生理監測器,尤其是利用高透氣與透濕功能的非防水材料構成上透濕層及下透濕層,並相互結合以保護夾附在其中的元件,且由下透濕層底下的背膠貼附到體表而固定,因而具高度的透濕性,可避免引起不適感,非常適合長時間使用,大幅改善使用上的便利性。The present invention relates to a physiological monitor, in particular, an upper moisture-permeable layer and a lower moisture-permeable layer are composed of non-waterproof materials with high air permeability and moisture permeability, and they are combined with each other to protect the components sandwiched therein. The adhesive under the wet layer is attached to the body surface and fixed, so it has a high degree of moisture permeability, which can avoid causing discomfort. It is very suitable for long-term use and greatly improves the convenience of use.
隨著醫學技術的不斷進步,許多疾病及生理訊號之間的相互關係已被詳細研究,例如,異常的血壓、心跳常會導致心血管疾病,因此,生理訊號量測裝置的使用已相當普遍,比如利用心律量測器量測的心律可當作健康狀態的指標性參考數據。With the continuous advancement of medical technology, the relationship between many diseases and physiological signals has been studied in detail. For example, abnormal blood pressure and heartbeat often lead to cardiovascular diseases. Therefore, the use of physiological signal measuring devices has become quite common, such as The heart rate measured by the heart rate measuring device can be used as an index reference data of health status.
傳統上,大部分的心律量測器是利用多個貼片狀的電極片貼附到胸部體表,藉以量測、放大相當微弱的心律訊號,並利用連接線將訊號傳送到處理裝置,比如電腦,進而顯示心律波形以方便直接觀察,同時經適當的訊號處理後判斷是否發生異常狀況,並產生預設的警示運作以提醒操作者注意。Traditionally, most heart rate measuring devices use multiple patch-like electrodes attached to the chest surface to measure and amplify rather weak heart rhythm signals, and use cables to transmit the signals to processing devices, such as The computer then displays the heart rhythm waveform to facilitate direct observation. At the same time, after proper signal processing, it is determined whether an abnormal situation occurs, and a preset warning operation is generated to remind the operator to pay attention.
不過上述的心律量測器只能在醫療院所進行,並不適合一般的居家環境,而且也無法長時間量測,所以對於體弱的年長者或病患來說,不能提供早期監測、防制潛在性疾病的發生。因此,近年來,學界、業界都一直在研發可隨身使用且長時間量測的生理監測器。However, the above-mentioned heart rate measuring devices can only be performed in medical institutions. They are not suitable for general home environment and cannot be measured for a long time. Therefore, for frail elderly or patients, early monitoring and prevention cannot be provided. The occurrence of underlying diseases. Therefore, in recent years, academia and the industry have been developing physiological monitors that can be used on the body and measured for a long time.
然而,上述習用技術的缺點在於生理監測器的透氣、透濕性不佳,很容易蓄積汗液,使得體表相當悶熱、潮濕,甚至過敏、紅腫、發癢,引起不適感。再者,這類裝置不具防水功能,要在洗澡、游泳之前先行移除,以避免影響電氣運作,所以使用上是相當不方便。However, the disadvantages of the above-mentioned conventional technology are that the physiological monitor has poor ventilation and moisture permeability, and it is easy to accumulate sweat, which makes the body surface quite hot, humid, and even allergic, red, swollen, and itchy, causing discomfort. Furthermore, this type of device is not waterproof, and must be removed before bathing or swimming to avoid affecting electrical operation, so it is quite inconvenient to use.
因此,需要一種創新的生理監測器,利用高透氣與透濕功能的非防水材料構成上透濕層及下透濕層,並相互結合以保護夾附在其中的元件,且由下透濕層底下的背膠貼附到體表而固定,因而具高度的透濕性,可避免引起不適感,非常適合長時間使用,大幅改善使用上的便利性,藉以解決習用技術的問題。Therefore, there is a need for an innovative physiological monitor that uses non-water-proof materials with high air permeability and moisture permeability to form an upper moisture-permeable layer and a lower moisture-permeable layer, which are combined with each other to protect the components attached to it, and the lower moisture-permeable layer The bottom adhesive is attached to the body surface and fixed, so it has a high degree of moisture permeability, which can avoid causing discomfort. It is very suitable for long-term use, greatly improving the convenience of use, and solving the problems of conventional technology.
本發明之主要目的在於提供一種生理監測器,包含封閉殼體、電路單元、保護套以及訊號量測貼片,可貼附於哺乳類動物的體表,例如人體皮膚,用以連續感測並記錄哺乳類動物的生理訊號,舉例來說心電圖訊號、肌電圖訊號或腦波訊號。The main purpose of the present invention is to provide a physiological monitor, including a closed casing, a circuit unit, a protective cover, and a signal measuring patch, which can be attached to the body surface of mammals, such as human skin, for continuous sensing and recording Physiological signals of mammals, such as electrocardiogram signals, electromyogram signals or brain wave signals.
封閉殼體包含上部殼體及下部殼體,係相互接合或藉黏膠結合而形成封閉且具有防水功效的容置空間。上部殼體具可按壓區,是在向下施力按壓或拍擊下而向下變形,且在施力釋放後而回復。封閉殼體具有導電性的至少二傳導結構,係穿過該下部殼體的底部。The closed shell includes an upper shell and a lower shell, which are joined to each other or combined with glue to form a closed and waterproof accommodating space. The upper shell has a depressible area, which deforms downward when the force is pressed or slapped downward, and returns after the force is released. The closed shell has at least two conductive structures with conductivity, which pass through the bottom of the lower shell.
電路單元是容置於容置空間內,並經由按鍵開關而連動到可按壓區,且在可按壓區被按壓時,經按鍵開關而觸發電路單元的預設電氣功能,比如包含連續感測並記錄該生理訊號以供讀取或是觸發事件記錄的功能,能夠提供連續生理訊號一個時間標記以便針對特定事件觀察分析,且傳導結構是電氣連接電路單元。保護套是包覆住封閉殼體,並具延展性、防水性、防塵性、防刮性以及減輕外力衝擊的作用。The circuit unit is accommodated in the accommodating space and linked to the depressible area via a key switch, and when the depressible area is pressed, the preset electrical function of the circuit unit is triggered by the key switch, such as continuous sensing and The function of recording the physiological signal for reading or triggering event recording can provide a time stamp of the continuous physiological signal for observation and analysis of specific events, and the conductive structure is electrically connected to the circuit unit. The protective sleeve covers the closed shell and has ductility, water resistance, dust resistance, scratch resistance and the function of reducing the impact of external forces.
進一步,訊號量測貼片是設置於封閉殼體底下,且包含上透濕層、至少二電極、至少二定位環、至少二導電水凝膠、基座以及下透濕層。此外,至少一空隙是介於訊號量測貼片與封閉殼體之間以利水氣流通,訊號量測貼片亦可從封閉殼體拆卸分離而更新替換。Furthermore, the signal measurement patch is disposed under the closed casing and includes an upper moisture-permeable layer, at least two electrodes, at least two positioning rings, at least two conductive hydrogels, a base, and a lower moisture-permeable layer. In addition, at least one gap is between the signal measurement patch and the closed casing to facilitate water flow, and the signal measurement patch can also be detached from the closed casing for replacement.
上透濕層具有上表面以及下表面,其中下部殼體是貼附於上透濕層的上表面,此外,上透濕層的至少一部分下表面係塗佈具有生物相容性的背膠,上透濕層具有至少一上透濕層開口,且每個上透濕層開口內是套設防水圈。The upper moisture-permeable layer has an upper surface and a lower surface. The lower shell is attached to the upper surface of the upper moisture-permeable layer. In addition, at least a part of the lower surface of the upper moisture-permeable layer is coated with a biocompatible adhesive. The upper moisture-permeable layer has at least one upper moisture-permeable layer opening, and each opening of the upper moisture-permeable layer is sheathed with a waterproof ring.
至少二電極貼附於上透濕層的下表面,且每個電極具有量側端部以及連結部,其中量側端部是由連結部朝側方向延伸而成,連結部是對齊於上透濕層開口。尤其,上透濕層開口的橫向尺寸是大於或等於連結部的橫向尺寸,傳導結構是穿過上透濕層開口而連接至連結部。At least two electrodes are attached to the lower surface of the upper moisture-permeable layer, and each electrode has a volume-side end and a connecting portion, wherein the volume-side end is formed by extending the connecting portion in a lateral direction, and the connecting portion is aligned with the upper transparent layer. Wet layer opening. In particular, the lateral dimension of the opening of the upper moisture-permeable layer is greater than or equal to the lateral dimension of the connecting portion, and the conductive structure passes through the opening of the upper moisture-permeable layer to connect to the connecting portion.
至少二定位環是貼附到該至少二電極的量側端部的下表面,而至少二導電水凝膠是位於該至少二定位環內,並貼附到該至少二電極的量側端部的下表面,其中定位環具有將該導電水凝膠定位的作用。At least two positioning rings are attached to the lower surface of the at least two electrodes at the volume-side ends, and at least two conductive hydrogels are located in the at least two positioning rings and attached to the volume-side ends of the at least two electrodes The positioning ring has the function of positioning the conductive hydrogel.
基座具有上表面以及下表面,而該至少二電極的連結部是貼附於基座的上表面,且該至少二電極的量側端部是在基座外。The base has an upper surface and a lower surface, and the connecting portion of the at least two electrodes is attached to the upper surface of the base, and the quantitative side ends of the at least two electrodes are outside the base.
下透濕層具有上表面以及下表面,其中基座是在下透濕層的上表面上,且下透濕層的橫向尺寸是小於上透濕層的橫向尺寸且下透濕層的橫向尺寸是大於基座的橫向尺寸。此外,下透濕層的至少一部分的下表面係塗佈具有生物相容性的背膠,且下透濕層可進一步具有未被基座遮蔽或覆蓋的至少二下透濕層開口,其中每個下透濕層開口是各別對齊該至少二電極的量測端部,且每個下透濕層開口是大於且容置該至少二定位環。The lower moisture-permeable layer has an upper surface and a lower surface, wherein the base is on the upper surface of the lower moisture-permeable layer, and the transverse dimension of the lower moisture-permeable layer is smaller than that of the upper moisture-permeable layer and the transverse dimension of the lower moisture-permeable layer is Larger than the lateral dimension of the base. In addition, at least a part of the lower surface of the lower moisture-permeable layer is coated with a biocompatible adhesive, and the lower moisture-permeable layer may further have at least two lower moisture-permeable layer openings that are not shielded or covered by the base, wherein each The openings of the lower moisture permeable layer are respectively aligned with the measuring ends of the at least two electrodes, and each opening of the lower moisture permeable layer is larger than and accommodates the at least two positioning rings.
更加具體而言,防水圈是透過膠黏合或熔接而直接固定於基座上以達水密功能,下透濕層的橫向尺寸是小於上透濕層的橫向尺寸,且上透濕層及下透濕層是透過物理或化學方式而結合,用以保護夾附在其中的元件。More specifically, the waterproof ring is directly fixed on the base through glue bonding or welding to achieve the watertight function. The horizontal dimension of the lower moisture-permeable layer is smaller than that of the upper moisture-permeable layer, and the upper moisture-permeable layer and the lower moisture-permeable layer The wet layer is combined through physical or chemical means to protect the components attached to it.
此外,下透濕層的背膠以及該至少二導電水凝膠是貼附於哺乳類動物的體表而固定,並由貼附至導電水凝膠的電極藉感測以產生哺乳類動物的生理訊號,且經由穿過上透濕層開口的傳導結構而傳送至電路單元。In addition, the back glue of the lower moisture-permeable layer and the at least two conductive hydrogels are attached to the body surface of mammals for fixation, and the electrodes attached to the conductive hydrogel are sensed to generate physiological signals of the mammals. , And transmitted to the circuit unit through the conductive structure passing through the opening of the upper moisture-permeable layer.
本發明的上透濕層及下透濕層是由高透氣與透濕功能的非防水材料構成,比如人工或天然纖維所製成的不織布,因而具有高度的透氣性及透濕性,可避免體表引起不適感,另外上透濕層及下透濕層兩者是重疊貼附,亦可避免外部水氣直接侵襲而造成其貼附於皮膚的能力快速衰減,所以是非常適合長時間使用,能大幅改善使用上的便利性。The upper moisture-permeable layer and the lower moisture-permeable layer of the present invention are composed of non-waterproof materials with high air permeability and moisture permeability, such as non-woven fabrics made of artificial or natural fibers, and therefore have high air permeability and moisture permeability, which can avoid The body surface causes discomfort. In addition, the upper moisture-permeable layer and the lower moisture-permeable layer are overlapped and attached, which can also prevent the direct invasion of external water and cause its ability to adhere to the skin rapidly decay, so it is very suitable for long-term use , Can greatly improve the convenience of use.
以下配合圖示及元件符號對本發明之實施方式做更詳細的說明,俾使熟習該項技藝者在研讀本說明書後能據以實施。The following is a more detailed description of the implementation of the present invention in conjunction with the diagrams and component symbols, so that those who are familiar with the art can implement it after studying this specification.
請同時參閱第一圖、第二圖及第三圖,其中第一圖為本發明實施例生理監測器的剖示圖,第二圖為生理監測器的分解爆炸示意圖,第三圖為生理監測器的分解爆炸示意圖。如第一圖、第二圖及第三圖所示,本發明實施例的生理監測器包含封閉殼體10、電路單元20、保護套30以及訊號量測貼片40,可貼附於哺乳類動物的體表上,用以連續感測並記錄哺乳類動物的生理訊號。Please refer to the first, second and third figures at the same time. The first figure is a cross-sectional view of the physiological monitor according to the embodiment of the present invention, the second figure is an exploded and exploded schematic diagram of the physiological monitor, and the third figure is a physiological monitoring The exploded schematic diagram of the device. As shown in the first, second and third figures, the physiological monitor of the embodiment of the present invention includes a closed
具體而言,封閉殼體10是包含上部殼體11及下部殼體12,其中上部殼體11及下部殼體1是利用接合方式或黏膠結合方式而相互結合以形成封閉且具有防水功效的容置空間13。進一步,上部殼體11具有可按壓區14,可在向下施力按壓或拍擊下而向下變形,且在施力釋放後而回復。封閉殼體10還包含具有導電性的至少二傳導結構15,係穿過下部殼體12的底部,尤其,該至少二傳導結構15與下部殼體12亦緊密封裝而具有防水功效。此外,下部殼體12亦向容置空間13內延伸出柱狀或牆面的結構,並與上部殼體11接觸,依此強化封閉殼體10的結構性。Specifically, the closed
電路單元20是容置於封閉殼體10的容置空間13內,並經由按鍵開關21而連動到上部殼體11的可按壓區14,且在可按壓14區被按壓時,可經按鍵開關14而觸發電路單元20的預設電氣功能,比如包含連續感測並記錄生理訊號以供讀取,或是觸發事件記錄的功能,能夠提供連續生理訊號一時間的標記以便針對特定事件觀察分析。此外,上述的至少二傳導結構15是電氣連接到電路單元20。進一步來說,下部殼體12可於製程時先將電路單元20置入其中,經過檢驗測試後再結合上部殼體11而製成封閉殼體10。The
保護套30包覆封閉殼體10,包含頂部及周圍,其中封閉殼體10可於底部長出凸出結構,並且保護套30可延伸出多個環形結構套住該凸出結構以固定住保護套30,尤其,保護套30具延展性、防水性、防塵性、防刮性以及減輕外力衝擊的作用。The
再者,訊號量測貼片40為多層結構組成,是位於封閉殼體10的下方且橫向向外延伸超出封閉殼體10的全部周圍一段距離以貼附於皮膚,具有訊號量測功能及黏貼性,並可長時間貼附到哺乳類動物的體表上而固定,且很容易撕下而剝離,尤其是不會引起不適感,也不容易留下殘膠。Furthermore, the
此外,訊號量測貼片40與封閉殼體10之間具有至少一空隙以利水氣流通,具體而言,訊號量測貼片40是位於下部殼體12的底部,並且該一訊號量測貼片40於各個方向延伸的橫向尺寸皆是大於封閉殼體10的橫向尺寸。In addition, there is at least one gap between the
進一步而言,訊號量測貼片40是包含由上而下依序堆疊的上透濕層50、至少二電極60、至少二定位環R、至少二導電水凝膠P、基座70以及下透濕層80,其中上透濕層50是向上與封閉殼體10的底部即下部殼體12的底部結合,且上透濕層50與下部殼體12的底部是部分接觸,另外,上透濕層50與下透濕層80是相互堆疊而結合的,彼此的橫向尺寸或重疊面積可以有多種組合,諸如,下透濕層80與上透濕層50的外邊緣是切齊一致的,或是下透濕層80的橫向尺寸是小於上透濕層50的橫向尺寸,或是下透濕層80的橫向尺寸是大於上透濕層50的橫向尺寸,另外,也可以是部分下透濕層80的橫向尺寸是小於上透濕層50的橫向尺寸,亦或是部分下透濕層80的橫向尺寸是大於上透濕層50橫向尺寸的組合,且上透濕層50及下透濕層80是透過物理或化學方式而結合,用以保護夾附在其中的元件。例如,上透濕層50及下透濕層80是透過熔接或膠黏合方式而緊密貼合。此外,下透濕層80中至少有1/3的外邊緣周長的橫向尺寸是大於上透濕層50,以利長時間貼附。進一步來說,上透濕層50的下表面含有背膠,且下透濕層80的下表面亦含有背膠,當下透濕層80的橫向尺寸是大於上透濕層50的橫向尺寸,或是下透濕層80與上透濕層50的外邊緣是切齊一致時,是該下透濕80層的下表面完整貼附於哺乳類動物的皮膚,而當下透濕層80的橫向尺寸是小於上透濕層50的橫向尺寸時,是該下透濕層80以及部分上透濕層50的下表面同時貼附於並接觸哺乳類動物的皮膚,因此具有強化貼附效果的作用。Furthermore, the
此外,下透濕層80的外邊緣周長的尺寸是小於上透濕層50,下透濕層80則完全或大部份被上透濕層50覆蓋,因此不會直接面對外力衝擊,例如淋浴,以利長時間貼附,尤其是當上透濕層50的貼附情形衰減時,可單獨將上透濕層移除,再換上新的上透濕層50,以利維持貼附的持久性。更佳者,使用者可額外覆蓋一具有黏性的貼布於上透濕層50上,部份黏在上透濕層50而其餘黏在皮膚上,藉此加強貼附的有效性。另一方面,下透濕層80可單獨由一可透濕或透氣的無基材雙面黏膠所組成,例如壓克力膠或熱熔膠,同樣具有吸汗、透氣等舒適特性,且由於不具備基材,其厚度較薄,可為0.05mm ~ 0.3mm之間,所以其黏膠邊緣與皮膚相黏之處,在使用期間不容易因外力干涉而被掀起。In addition, the outer edge circumference of the lower moisture-
上透濕層50具有上表面以及下表面,而下部殼體12是設置於上透濕層50的上表面,且上透濕層50還具有至少一上透濕層開口52,其中每個上透濕層開口52內都是套設防水圈54。The upper moisture-
每個電極60是貼附於上透濕層50的下表面,且具有量側端部61以及連結部62,其中連結部62是集中分佈在與下部殼體12重疊的範圍之內,且量測端部61是由連結部62朝側方向延伸而成。每個電極60及其延伸路徑彼此互不干涉,量測端部61可具有比連結部62更大的面積,以達成良好的量測效果。連結部62是對齊於上透濕層開口52,尤其,上透濕層開口52的橫向尺寸是大於或等於連結部62的橫向尺寸,更進一步說明,每個電極60的量測端部61可直接或間接接觸哺乳類動物皮膚以感測體表的心電訊號,而連結部62位是於上透濕層50之下,連結部62與量測端部61亦有垂直方向的電氣連結。此外,傳導結構15是穿過上透濕層開口52而連接至連結部62,因此哺乳類動物的生理訊號如心電訊號可從量測端部61的下表面傳遞至連結部62的上表面再傳遞至傳導結構15,進一步可傳遞到電路單元20中處理與記錄,另一方面,傳導結構15可與連結部62分離,亦即訊號量測貼片40可從下部殼體12脫離而實施更換。Each
進一步說明,該至少二電極60可由具有導電性及離子導電性的銀與氯化銀之化合物(Ag/AgCl)所形成,另一方面,亦可藉由塗布Ag/AgCl、銀、碳或石墨等導電塗佈層於可撓曲的基材上所形成,即塗佈於量測端部61和連結部62以及連接兩者之間的路經,且該基材可為PET、PE、PP、PC等或是軟性電路板所組成之材料。Furthermore, the at least two
另外,該至少二電極60中相距較近之量測端部61,其中心點之間的距離至少為4cm,此外該至少二電極60的下表面與下透濕層之間進一步具有一電氣及水氣之絕緣層L,可確保每個電極60之間的電氣傳導能夠獨立運作且不互相干擾。In addition, the measurement ends 61 of the at least two
每個定位環R是貼附到相對應的量測端部61的下表面,定位環R也可以貼附到量測端部61下表面的至少一部分導電塗佈層上,且導電水凝膠P是位於相對應量的定位環R內,並貼附到量測端部61的下表面。導電水凝膠P貼附於哺乳類動物的皮膚可做為感測生理訊號的良好介質,又其中水凝膠P是透過定位環R而與下透濕層80形成隔閡,彼此不易互相接觸或產生電氣連結。Each positioning ring R is attached to the lower surface of the
基座70是由一硬式材質所組成,例如塑膠,具有上表面以及下表面,其中基座70是與封閉殼體10所結合。另外,該至少二電極60是緊貼基座70的上表面,係平行於該上表面而分布。進一步來說,電極60的連結部62是貼附於基座70的上表面,且每個電極60的量測端部61都是在基座70外,亦即量測端部61是未被基座70支撐住,因此具有可撓曲的特性,而且每個電極的量測端部61中心點與相鄰的基座70外邊緣之距離為大於10mm。連結部62是與封閉殼體10的傳導結構15垂直結合以傳遞感測電氣訊號。另一方面,基座70的厚度是高於電極60與下透濕層80堆疊的厚度,亦即基座70的厚度為0.5mm到10mm之間,因此在貼附在皮膚上時,電極60在基座70外所形成的水平高度是低於位在基座70上表面的水平高度,亦即量測端部61的高度是低於連結部62,以便將電極60服貼於皮膚上。此外,防水圈54是透過膠黏合或熔接而直接固定於基座70上,藉以與封閉殼體10結合時達水密功能,而且每個防水圈54是各自對應到一傳導結構15,讓每個傳導結構15獨立被保護在防水圈54內,所以彼此傳遞的訊號不會互相干擾。上透濕層50貼附於基座70上,更進一步沿著基座70的側邊邊緣貼附,上透濕層50分佈於基座70上的水平高度是高於上透濕層50其餘部分的水平高度。The
下透濕層80具有上表面以及下表面,且基座70是在下透濕層80的上表面上,且下透濕層80的至少一部分的下表面係塗佈具有生物相容性的背膠,進一步可貼附於哺乳類動物的皮膚表面以達到固定裝置於體表的功能。尤其是,下透濕層80還進一步具有未被基座70遮蔽或覆蓋的至少二下透濕層開口82,該至少二電極60的量測端部61是對齊該至少二下透濕層開口82,並透過開口直接或間接結合皮膚以達量測效果。另外,下透濕層80可為一片式,其所分佈的範圍涵蓋上透濕層50、電極60以及基座70,尤其是下透濕層80的整個下表面皆塗佈背膠。較佳的,上透濕層50及下透濕層80是由具有高透氣與透濕功能的非防水材料構成,具有高度的水氣透過率(moisture vapor transmission rate, MVTR),例如400 gm/m2/24 hr以上,且非防水材料可為人工或天然纖維所製成的不織布或織布。進一步來說,不織布亦稱無紡布,透過對人工或天然纖維的不同加工,可分成「水針(水刺)、熱風、熱軋、無塵」四種布質,且可為白色或黑色的呈色,該不織布的材料又可細分為壓克力(Acrylic)、棉(Cotton)、聚酯(Polyester)、聚乙烯對苯二甲酸酯(PET)、聚胺酯(Polyurethane)、聚丙烯(Polypropylene)、耐綸(Nylon)、嫘縈布(Rayon)等內含材質。The lower moisture-
再者,下透濕層80的背膠以及每個導電水凝膠P是貼附於哺乳類動物的體表而固定,並由貼附至導電水凝膠P的電極60藉感測而產生哺乳類動物的生理訊號,且經由穿過上透濕層開口52的傳導結構15而傳送至電路單元20。Furthermore, the back glue of the lower moisture-
上述的生理訊號可包含心律訊號、心電訊號、肌電訊號或腦波訊號等各種生理電訊號,且導電水凝膠P是由樹脂、水、電解質、醇類等物質化合而形成,並具有離子導電性及黏性,而定位環R是透過膠黏合或熔接方式而固定於相對應的電極60。The above-mentioned physiological signals can include various physiological signals such as heart rhythm signal, electrocardiographic signal, myoelectric signal or brain wave signal, and the conductive hydrogel P is formed by the combination of resin, water, electrolyte, alcohol and other substances, and has Ionic conductivity and adhesiveness, and the positioning ring R is fixed to the corresponding
具體而言,電路單元20可包含電路基板、多個電子元件、資料存取接口、控制器單元、加速規單元、電池以及記憶體(圖中未顯示)。Specifically, the
進一步,資料存取接口是固定於電路基板上,並電氣連接至控制器單元、電池及記憶體,且資料存取接口可連結至外部裝置而進行資料傳輸,或對電池進行充電,其中電池可為一次性或可充電電池,用以供應電力。Further, the data access interface is fixed on the circuit board and electrically connected to the controller unit, battery and memory, and the data access interface can be connected to an external device for data transmission or to charge the battery. The battery can be It is a disposable or rechargeable battery to supply electricity.
控制器單元電氣連結電池及記憶體,用以將感測到的生理訊號數位化並程式化,進而控制系統運作的行為模式。另一方面,控制器單元亦可實施運算功能,將所接收到的生理訊號轉換成心跳率(heart rate)資訊而儲存或傳遞到外部裝置。加速規單元係對生理監測器於X、Y、Z三軸空間中的運動軌跡進行量測,並藉由對生理監測器的運動軌跡之判斷以分析使用者的行為習慣以及觸發事件記錄。The controller unit is electrically connected to the battery and the memory to digitize and program the sensed physiological signals, and then control the behavior mode of the system operation. On the other hand, the controller unit can also implement arithmetic functions to convert received physiological signals into heart rate information for storage or transmission to an external device. The accelerometer unit measures the motion trajectory of the physiological monitor in the X, Y, and Z three-axis space, and analyzes the user's behavior habits and trigger event recording by judging the motion trajectory of the physiological monitor.
例如,外部裝置可包含USB單元,記憶體可為內建於電路基板上的快閃記憶體,或是插設於電路基板上一記憶體插槽的儲存卡。For example, the external device may include a USB unit, and the memory may be a flash memory built on the circuit board, or a memory card inserted into a memory slot on the circuit board.
另外,電路單元20可進一步具有無線傳輸單元(圖中未顯示),而無線傳輸單元可包含藍牙、WiFi、Zigbee、行動通訊或光通訊傳輸單元,用以將已數位化的生理訊號,藉無線方式傳輸至手機、平板電腦或電腦等外部裝置,並經由外部裝置的圖形化訊號以便於觀察及解讀該生理訊號。該無線傳輸單元亦可透過按鍵開關21的觸發行為而與外部裝置連結並且進行資料傳輸。另一方面,電路單元20具有一電源供應單元(圖中未顯示),供應整體電路單元20系統運作所需的電力,又其中該電源供應單元可為一次性或可充電之電池。進一步來說,電路單元20亦具有一磁力啟動單元(圖中未顯示),能透過特定磁性與磁力的外部磁力工具,例如磁鐵,接近該磁力啟動單元來達成與該按鍵開關21相同的電氣觸發、傳輸觸發或事件觸發功能。In addition, the
再者,保護套30可進一步具有延伸結構,用以插入上述的資料存取接口而達到水密功能,且保護套30的表面是具有突起狀或凹陷狀的非平面區域,用以對應到封閉殼體10的可按壓區14,提供使用者藉至少一手指的觸感而找到突起位置,藉以準確按壓到可按壓區14。進一步,保護套14的表面可再具有至少二限位凸點,係圍繞突起區域以避免突起區域遭到誤壓。此外,保護套30可具有一開口以容置電路單元20的資料存取接口,另一方面,可額外有一軟性塞子塞入該資料存取接口,具防水功能且避免落塵進入資料存取接口中。Furthermore, the
基座70可包含至少一結構干涉體71,係垂直於基座70的水平表面,且上透濕層50具有至少一對位開口,而下部殼體12具有至少一對位開口,且上透濕層50的至少一對位開口以及下部殼體12的至少一對位開口是對準於該至少一結構干涉體71,並由該至少一結構干涉體71穿過上透濕層50的至少一對位開口以套入下部殼體12的至少一對位開口而固定。另外,防水圈54是透過膠黏合或熔接而直接固定於基座70上,藉以與下部殼體12結合時,其內部空間達水密功能。具體來說,防水圈54主要是透過該至少一結構干涉體71與下部殼體12互相干涉,迫使下部殼體12壓縮防水圈54而緊密結合,其中該至少一結構干涉體71之一的分佈是緊鄰防水圈54。例如,該結構干涉體71與防水圈54邊緣最短的水平距離是小於20mm。下部殼體12與基座70的表面無直接接觸,或者,上透濕層50或基座70與下部殼體12之間是非完全結合因而透水且透氣的。尤其,上透濕層80是貼附於基座70上且防水圈54的厚度是高於上透濕層80的厚度,可為0.05 mm ~ 10mm。因此,下部殼體12的底部與基座70或是上透濕層80之間至少有一空隙,其高度如0.05 mm ~ 10mm,讓其間的水氣得以流通,以利長期貼附。此外,基座70可具有多個孔洞結構,係分佈於大部份的基座70,且不涵蓋到基座70與該電極量測端部61以及防水圈54重疊的區域,藉此以提升訊號量測貼片的透氣性。The base 70 may include at least one
尤其是,本發明的生理監測器可進一步包含至少一離型層90,是貼附於透濕層50或下透濕層80的下表面,且離型層90的橫向尺寸是大於或等於透濕層50與下透濕層80的橫向尺寸,其中上透濕層50或下透濕層80的背膠以及該至少二導電水凝膠P是在離型層90被剝除後而裸露。較佳的,離型層90可為兩片式部份相互交疊的形式,或兩片式部份摺合的形式,以利於使用者移除操作。In particular, the physiological monitor of the present invention may further include at least one
綜上所述,本發明的主要特點在於利用高透氣與透濕功能的非防水材料構成上透濕層及下透濕層,並相互結合以保護夾附在其中的元件,包含電極、定位環、導電水凝膠、基座,藉以構成訊號量測貼片,且在訊號量測貼片上配置封閉殼體,用以容置電氣連接至訊號量測貼片的電路單元,並由下透濕層底下的背膠貼附到哺乳類動物的體表上而固定,因而能連續感測並記錄該哺乳類動物的生理訊號。尤其,上透濕層及下透濕層是由具有高透氣與透濕功能的非防水材料構成。另一方面,透濕也代表材料具有吸水功能,能夠吸附汗水,可避免引起不適感,該上、下透濕層相互堆疊結合也具有某種程度的阻水性,可降低外部水氣對下透濕層底下背膠黏性的影響,例如淋浴時的水第一時間會被阻擋在透濕層外,不會直接衝擊背膠,整體而言該透濕層非常適合長時間使用,大幅改善使用上的便利性。In summary, the main feature of the present invention is to use non-waterproof materials with high air permeability and moisture permeability to form the upper moisture-permeable layer and the lower moisture-permeable layer, and they are combined to protect the components attached to them, including electrodes and positioning rings. , Conductive hydrogel, and base to form a signal measurement patch, and a closed shell is arranged on the signal measurement patch to accommodate the circuit unit electrically connected to the signal measurement patch, and is transparent The adhesive under the wet layer is attached to and fixed on the body surface of the mammal, so that it can continuously sense and record the physiological signal of the mammal. In particular, the upper moisture-permeable layer and the lower moisture-permeable layer are made of non-waterproof materials with high air permeability and moisture permeability. On the other hand, moisture permeability also means that the material has a water-absorbing function, can absorb sweat, and can avoid causing discomfort. The upper and lower moisture-permeable layers are stacked and combined with each other and also have a certain degree of water resistance, which can reduce the penetration of external water vapor to the bottom. The adhesive under the wet layer is affected by the viscosity of the adhesive. For example, the water in the shower will be blocked out of the moisture-permeable layer for the first time and will not directly impact the adhesive. On the whole, the moisture-permeable layer is very suitable for long-term use, which greatly improves the use Convenience.
本發明的另一特點在於利用定位環限制導電水凝膠而貼附並固定於電極的下方,因此,電極實際上並未接觸到體表,而是由導電水凝膠接觸體表,而由於導電水凝膠本身具有良好導電性,所以能將體表的微弱電氣訊號傳導至電極,進一步經由傳導結構而傳送至電路單元以進行訊號處理而達到生理監測的目的。Another feature of the present invention is that the conductive hydrogel is attached and fixed below the electrode by the positioning ring. Therefore, the electrode does not actually touch the body surface, but the conductive hydrogel touches the body surface. The conductive hydrogel itself has good conductivity, so it can conduct the weak electrical signals on the body surface to the electrodes, and then transmit them to the circuit unit through the conductive structure for signal processing to achieve the purpose of physiological monitoring.
以上所述者僅為用以解釋本發明之較佳實施例,並非企圖據以對本發明做任何形式上之限制,是以,凡有在相同之發明精神下所作有關本發明之任何修飾或變更,皆仍應包括在本發明意圖保護之範疇。The above descriptions are only used to explain the preferred embodiments of the present invention, and are not intended to restrict the present invention in any form. Therefore, any modification or change related to the present invention is made under the same spirit of the invention. , Should still be included in the scope of the present invention's intention to protect.
10:封閉殼體10: Closed shell
11:上部殼體11: Upper shell
12:下部殼體12: Lower shell
13:容置空間13: accommodating space
14:按壓區14: Compression zone
15:傳導結構15: Conductive structure
20:電路單元20: circuit unit
21:按鍵開關21: key switch
30:保護套30: protective sleeve
40:訊號量測貼片40: Signal measurement patch
50:上透濕層50: Upper moisture-permeable layer
52:上透濕層開口52: Upper moisture-permeable layer opening
54:防水圈54: Waterproof ring
60:電極60: Electrode
61:量側端部61: Measuring side end
62:連結部62: Connection
70:基座70: Pedestal
71:結構干涉體71: Structural Interference Body
80:下透濕層80: Lower moisture permeable layer
82:下透濕層開口82: Lower moisture permeable layer opening
90:離型層90: Release layer
L:絕緣層L: insulating layer
P:導電水凝膠P: Conductive hydrogel
R:定位環R: positioning ring
第一圖顯示依據本發明實施例生理監測器的剖示圖。 第二圖顯示依據本發明實施例生理監測器的分解爆炸示意圖。 第三圖顯示依據本發明實施例生理監測器中訊號量測貼片的分解爆炸示意圖。 The first figure shows a cross-sectional view of a physiological monitor according to an embodiment of the present invention. The second figure shows a schematic exploded exploded view of the physiological monitor according to an embodiment of the present invention. The third figure shows the exploded schematic diagram of the signal measurement patch in the physiological monitor according to the embodiment of the present invention.
10:封閉殼體 10: Closed shell
11:上部殼體 11: Upper shell
12:下部殼體 12: Lower shell
13:容置空間 13: accommodating space
14:可按壓區 14: Pressable area
15:傳導結構 15: Conductive structure
20:電路單元 20: circuit unit
21:按鍵開關 21: key switch
30:保護套 30: protective sleeve
40:訊號量測貼片 40: Signal measurement patch
50:上透濕層 50: Upper moisture-permeable layer
52:上透濕層開口 52: Upper moisture-permeable layer opening
54:防水圈 54: Waterproof ring
60:電極 60: Electrode
61:量側端部 61: Measuring side end
62:連結部 62: Connection
70:基座 70: Pedestal
80:下透濕層 80: Lower moisture permeable layer
82:下透濕層開口 82: Lower moisture permeable layer opening
90:離型層 90: Release layer
P:導電水凝膠 P: Conductive hydrogel
R:定位環 R: positioning ring
Claims (9)
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Citations (2)
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CN105050490A (en) * | 2013-03-12 | 2015-11-11 | 维塔尔康奈克特公司 | Disposable biometric patch device |
WO2019241753A1 (en) * | 2018-06-15 | 2019-12-19 | Proteus Digital Health, Inc. | Re-wearable physiological monitoring device |
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CN105050490A (en) * | 2013-03-12 | 2015-11-11 | 维塔尔康奈克特公司 | Disposable biometric patch device |
WO2019241753A1 (en) * | 2018-06-15 | 2019-12-19 | Proteus Digital Health, Inc. | Re-wearable physiological monitoring device |
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