TWI742368B - Electrocardiography patch and method of manufacturing the same - Google Patents
Electrocardiography patch and method of manufacturing the same Download PDFInfo
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- TWI742368B TWI742368B TW108115941A TW108115941A TWI742368B TW I742368 B TWI742368 B TW I742368B TW 108115941 A TW108115941 A TW 108115941A TW 108115941 A TW108115941 A TW 108115941A TW I742368 B TWI742368 B TW I742368B
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- 238000004519 manufacturing process Methods 0.000 title claims description 14
- 238000002565 electrocardiography Methods 0.000 title abstract description 3
- 229910052751 metal Inorganic materials 0.000 claims abstract description 182
- 239000002184 metal Substances 0.000 claims abstract description 182
- 238000007789 sealing Methods 0.000 claims abstract description 76
- 239000002344 surface layer Substances 0.000 claims description 41
- 238000000034 method Methods 0.000 claims description 15
- 239000012790 adhesive layer Substances 0.000 claims description 10
- 230000003014 reinforcing effect Effects 0.000 claims description 8
- 238000005530 etching Methods 0.000 claims description 5
- 238000003825 pressing Methods 0.000 claims description 3
- 238000005520 cutting process Methods 0.000 claims 1
- 238000004080 punching Methods 0.000 claims 1
- 238000005452 bending Methods 0.000 description 10
- PXHVJJICTQNCMI-UHFFFAOYSA-N Nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 description 7
- 210000000038 chest Anatomy 0.000 description 7
- 238000010586 diagram Methods 0.000 description 6
- 210000003414 extremity Anatomy 0.000 description 5
- 230000006698 induction Effects 0.000 description 5
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 4
- 229910052709 silver Inorganic materials 0.000 description 4
- 239000004332 silver Substances 0.000 description 4
- 229910052759 nickel Inorganic materials 0.000 description 3
- 239000005020 polyethylene terephthalate Substances 0.000 description 3
- 229920000139 polyethylene terephthalate Polymers 0.000 description 3
- 210000002445 nipple Anatomy 0.000 description 2
- 210000004197 pelvis Anatomy 0.000 description 2
- 229920000515 polycarbonate Polymers 0.000 description 2
- 239000004417 polycarbonate Substances 0.000 description 2
- -1 polyethylene terephthalate Polymers 0.000 description 2
- 229910000881 Cu alloy Inorganic materials 0.000 description 1
- 229910045601 alloy Inorganic materials 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 210000003423 ankle Anatomy 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000002612 cardiopulmonary effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000007731 hot pressing Methods 0.000 description 1
- 230000003601 intercostal effect Effects 0.000 description 1
- 239000010410 layer Substances 0.000 description 1
- WABPQHHGFIMREM-UHFFFAOYSA-N lead(0) Chemical compound [Pb] WABPQHHGFIMREM-UHFFFAOYSA-N 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
- 210000000707 wrist Anatomy 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
- A61B5/282—Holders for multiple electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/683—Means for maintaining contact with the body
- A61B5/6832—Means for maintaining contact with the body using adhesives
- A61B5/6833—Adhesive patches
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- Animal Behavior & Ethology (AREA)
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- Veterinary Medicine (AREA)
- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
Abstract
Description
本揭露是有關於一種心電圖貼片及一種心電圖貼片的製造方法。 The present disclosure relates to an electrocardiogram patch and a manufacturing method of the electrocardiogram patch.
心電圖(electrocardiograph,ECG)偵測器廣泛應用於獲得與心肺系統相關之電性活動的醫學(即生物電位)訊號。心電圖電極被施加於患者皮膚的各個位置以獲得醫學訊號。將電極定位於患者身上後,電極透過一組心電圖導線耦接至心電圖偵測器。心電圖導線的遠端可包含連接器,連接器透過按扣耦接至電極以接收來自身體的醫學訊號。心電圖導線的近端透過轉接器耦接至心電圖偵測器,並將從身體接收的醫學訊號提供至心電圖偵測器。 Electrocardiograph (ECG) detectors are widely used to obtain medical (ie, biopotential) signals related to the electrical activity of the cardiopulmonary system. Electrocardiogram electrodes are applied to various parts of the patient's skin to obtain medical signals. After positioning the electrodes on the patient, the electrodes are coupled to the ECG detector through a set of ECG wires. The distal end of the electrocardiogram lead may include a connector, and the connector is coupled to the electrode through a snap button to receive medical signals from the body. The proximal end of the electrocardiogram wire is coupled to the electrocardiogram detector through the adapter, and provides the medical signal received from the body to the electrocardiogram detector.
包含電極及導線的傳統心電圖組件可透過類似於形成軟性印刷電路(flexible printed circuit,FPC)的方法製造,例如蝕刻製程及顯影製程。此外,心電圖組件可透過銀漿印刷的方式製造。 The traditional electrocardiogram device including electrodes and wires can be manufactured by a method similar to forming a flexible printed circuit (FPC), such as an etching process and a developing process. In addition, ECG components can be manufactured by silver paste printing.
然而,上述的傳統方法導致心電圖組件的成本過高,且使用銀漿印刷可能降低心電圖組件的品質穩定性。此 外,心電圖組件具有兩種類型,分別為可調式(無定位)類型及不可調式(定位)類型。可調式心電圖組件的位置可透過拉伸來調節,但只有專業人員才能操作可調式心電圖組件。不可調式心電圖組件的位置可能無法根據患者身體的尺寸進行調整。 However, the above-mentioned traditional methods result in excessively high cost of the ECG component, and the use of silver paste printing may reduce the quality stability of the ECG component. this In addition, there are two types of ECG components, which are adjustable (no positioning) type and non-adjustable (positioning) type. The position of the adjustable ECG component can be adjusted by stretching, but only professionals can operate the adjustable ECG component. The position of the non-adjustable ECG component may not be adjusted according to the size of the patient's body.
本揭露之一技術態樣為一種心電圖貼片。 One technical aspect of this disclosure is an electrocardiogram patch.
根據本揭露一實施方式,一種心電圖貼片包含具有底部密封膜、頂部密封膜、至少一第一金屬帶及至少一第二金屬帶的主體。第一金屬帶及第二金屬帶位於底部密封膜與頂部密封膜之間。第一金屬帶及第二金屬帶具有第一端及第二端。第一金屬帶的第一端具有感應區,且第二金屬帶的第一端具有接觸區。 According to one embodiment of the present disclosure, an electrocardiogram patch includes a main body having a bottom sealing film, a top sealing film, at least one first metal strip and at least one second metal strip. The first metal belt and the second metal belt are located between the bottom sealing film and the top sealing film. The first metal belt and the second metal belt have a first end and a second end. The first end of the first metal strip has a sensing area, and the first end of the second metal strip has a contact area.
本揭露之一技術態樣為一種心電圖貼片的製造方法。 One technical aspect of this disclosure is a manufacturing method of an electrocardiogram patch.
根據本揭露一實施方式,一種心電圖貼片的製造方法,包含下列步驟:由金屬片形成圖案化金屬結構,其中圖案化金屬結構具有複數個金屬帶;以及熱壓合底部密封膜、圖案化金屬結構及頂部密封膜。 According to an embodiment of the present disclosure, a method for manufacturing an electrocardiogram patch includes the following steps: forming a patterned metal structure from a metal sheet, wherein the patterned metal structure has a plurality of metal strips; and thermally pressing the bottom sealing film and the patterned metal Structure and top sealing film.
根據本揭露上述實施方式,由於心電圖貼片的主體具有位於底部密封膜與頂部密封膜之間的第一金屬帶及第二金屬帶,因此可透過沖壓與熱壓合以形成心電圖貼片而無須進行蝕刻、顯影及銀漿印刷。如此一來,可降低心電圖貼片的電阻及製造成本,且可提高心電圖貼片的品質穩定性。此外, 由於第一金屬帶的第一端具有感應區,因此可省略傳統心電圖的導線與電極之間之按扣連接的組裝時間及拆卸時間。此外,第二金屬帶的第一端具有能夠電性耦接至手臂與腿之延伸部的接觸區域。另外,由於第一金屬帶的第二端及第二金屬帶的第二端為並排排列,這樣的配置可使心電圖偵測器容易耦接至轉接器(例如軟性印刷電路連接器)。 According to the above-mentioned embodiments of the present disclosure, since the main body of the electrocardiogram patch has the first metal strip and the second metal strip between the bottom sealing film and the top sealing film, it can be formed by stamping and hot pressing to form the electrocardiogram patch without the need Perform etching, development and silver paste printing. In this way, the resistance and manufacturing cost of the ECG patch can be reduced, and the quality stability of the ECG patch can be improved. also, Since the first end of the first metal band has a sensing area, the assembly time and disassembly time of the snap connection between the lead wire and the electrode of the traditional electrocardiogram can be omitted. In addition, the first end of the second metal band has a contact area that can be electrically coupled to the extension part of the arm and the leg. In addition, since the second end of the first metal strip and the second end of the second metal strip are arranged side by side, this configuration allows the ECG detector to be easily coupled to the adapter (such as a flexible printed circuit connector).
應瞭解到,上述的一般性描述及後續的詳細描述均為示例性說明,且旨在提供本揭露所欲保護之範圍的進一步解釋。 It should be understood that the above general description and the subsequent detailed description are exemplary descriptions, and are intended to provide further explanation of the scope of protection intended by the present disclosure.
100、100a‧‧‧心電圖貼片 100, 100a‧‧‧ECG patch
110‧‧‧主體 110‧‧‧Main body
111a‧‧‧第一彎曲部 111a‧‧‧First bending part
111b‧‧‧第二彎曲部 111b‧‧‧Second bending part
112‧‧‧頂表面層 112‧‧‧Top surface layer
113‧‧‧底表面層 113‧‧‧Bottom surface layer
114‧‧‧頂部密封膜 114‧‧‧Top Sealing Film
115‧‧‧底部密封膜 115‧‧‧Bottom sealing film
116‧‧‧第一金屬帶 116‧‧‧The first metal belt
1161‧‧‧帶狀部 1161‧‧‧belt
117‧‧‧第一端 117‧‧‧First end
118‧‧‧第二端 118‧‧‧Second end
119、119a‧‧‧感應區 119、119a‧‧‧Induction zone
122‧‧‧側壁部 122‧‧‧Sidewall
123‧‧‧底部 123‧‧‧Bottom
126‧‧‧第二金屬帶 126‧‧‧Second Metal Belt
127‧‧‧第一端 127‧‧‧First end
128‧‧‧第二端 128‧‧‧Second end
129‧‧‧接觸區 129‧‧‧Contact area
130、130a‧‧‧延伸部 130, 130a‧‧‧Extension
132‧‧‧頂表面層 132‧‧‧Top surface layer
133‧‧‧底表面層 133‧‧‧Bottom surface layer
134‧‧‧頂部密封膜 134‧‧‧Top sealing film
135‧‧‧底部密封膜 135‧‧‧Bottom sealing film
136‧‧‧第三金屬帶 136‧‧‧The third metal belt
1361‧‧‧帶狀部 1361‧‧‧Band
137‧‧‧第一端 137‧‧‧First end
138‧‧‧第二端 138‧‧‧Second end
139‧‧‧感應區 139‧‧‧Induction zone
140‧‧‧對位標記 140‧‧‧Registration mark
150‧‧‧補強板 150‧‧‧Reinforcing plate
160‧‧‧導電凝膠 160‧‧‧Conductive gel
170‧‧‧雙面黏膠層 170‧‧‧Double-sided adhesive layer
180a‧‧‧第一離形紙 180a‧‧‧The first release paper
180b、180c‧‧‧第二離形紙 180b、180c‧‧‧Second release paper
4-4、4’-4’‧‧‧線段 4-4, 4’-4’‧‧‧ line segment
V1~V6‧‧‧符號 V1~V6‧‧‧Symbol
RA、RL、LA、LL‧‧‧符號 RA, RL, LA, LL‧‧‧ symbols
D1、D2‧‧‧直徑 D1, D2‧‧‧diameter
S1、S2‧‧‧步驟 S1, S2‧‧‧Step
L1~L5‧‧‧虛線 L1~L5‧‧‧Dotted line
第1圖繪示根據本揭露一實施方式之心電圖貼片的上視圖。 Fig. 1 shows a top view of an electrocardiogram patch according to an embodiment of the present disclosure.
第2圖繪示當第1圖之心電圖貼片的感應區貼附於患者身體時的位置示意圖。 Figure 2 is a schematic diagram showing the position of the electrocardiogram patch of Figure 1 when the sensing area is attached to the patient's body.
第3A圖繪示第1圖之心電圖貼片的內部結構示意圖。 Figure 3A is a schematic diagram of the internal structure of the ECG patch of Figure 1.
第3B圖繪示與第3A圖不同的另一實施方式之心電圖貼片的內部結構示意圖。 FIG. 3B is a schematic diagram of the internal structure of an electrocardiogram patch according to another embodiment that is different from FIG. 3A.
第4圖繪示第1圖之心電圖貼片沿線段4-4或線段4’-4’的剖面圖。 Figure 4 shows a cross-sectional view of the ECG patch of Figure 1 along the line 4-4 or the line 4'-4'.
第5圖繪示第4圖的局部放大圖。 Figure 5 shows a partial enlarged view of Figure 4.
第6圖繪示根據本揭露一實施方式之心電圖貼片的製造方法的流程圖。 FIG. 6 shows a flowchart of a method for manufacturing an electrocardiogram patch according to an embodiment of the present disclosure.
第7圖繪示根據本揭露一實施方式之心電圖貼片的上視圖。 FIG. 7 is a top view of an electrocardiogram patch according to an embodiment of the present disclosure.
以下將以圖式揭露本揭露之複數個實施方式,為明確說明起見,許多實務上的細節將在以下敘述中一併說明。然而,應瞭解到,這些實務上的細節不應用以限制本揭露。也就是說,在本揭露部分實施方式中,這些實務上的細節是非必要的。此外,為簡化圖式起見,一些習知慣用的結構與元件在圖式中將以簡單示意的方式繪示之。 Hereinafter, a plurality of implementation manners of the present disclosure will be disclosed in diagrams. For the sake of clarity, many practical details will be described in the following description. However, it should be understood that these practical details should not be used to limit this disclosure. In other words, in some implementations of this disclosure, these practical details are unnecessary. In addition, in order to simplify the drawings, some conventionally used structures and elements are shown in the drawings in a simple and schematic manner.
第1圖繪示根據本揭露一實施方式之心電圖(electrocardiography,ECG)貼片100的上視圖。第2圖繪示當第1圖之心電圖貼片100的感應區119、139貼附於患者身體時的位置示意圖。如第1圖及第2圖所示,心電圖貼片100包含彈性主體110及至少一個彈性延伸部130。延伸部130電性耦接至主體110。在較佳的實施方式中,彈性主體110可作為胸前導程(precordial lead),且延伸部130可作為標準肢導程(standard limb lead)。彈性主體110可覆蓋在患者的胸部上。在較佳的實施方式中,心電圖貼片100包含四個延伸部130,且每個延伸部130具有一個感應區139,例如符號LA、RA、LL及RL所標示的位置。此外,主體110具有六個感應區119,例如符號V1、V2、V3、V4、V5及V6所標示的位置。在下文中,這十個符號分別用於描述各種不同的位置。
FIG. 1 shows a top view of an electrocardiography (ECG)
當使用心電圖貼片100時,延伸部130的四個感應
區139可分別貼附至患者四肢的手腕及腳踝處,且主體110的六個感應區119可貼附至患者心臟周圍的胸部位置,如第2圖所示。心電圖貼片100可作為具有十個電極的標準十二導程心電圖貼片。在較佳的實施方式中,延伸部130的四個感應區139可交替地定位於右肩、左肩、右骨盆及左骨盆。然而,感應區119的數量及感應區139的數量並不用以限制本揭露,且每個數量可依設計者的需求而定。
When using the
在一些實施方式中,主體110還具有類似十字形的對位標記140。當心電圖貼片100的主體110貼附至患者身體時,對位標記140的水平線可定位在與乳頭對齊的第四肋間隙上,使得V1及V2位於兩個乳頭之間相同的線上,且對位標記140的垂直線可與患者身體的中心線對齊。
In some embodiments, the
在以下敘述中,將詳細說明第1圖之心電圖貼片100的結構。
In the following description, the structure of the
第3A圖繪示第1圖之心電圖貼片100的內部結構示意圖。第4圖繪示第1圖之心電圖貼片100沿線段4-4或線段4’-4’的剖面圖。如第3A圖及第4圖所示,主體110具有頂部密封膜114、底部密封膜115、至少一個第一金屬帶116及至少一個第二金屬帶126。第一金屬帶116及第二金屬帶126位於底部密封膜115與頂部密封膜114之間,且用以作為導電路徑以取代傳統的心電圖導線。
FIG. 3A is a schematic diagram of the internal structure of the
在一些實施方式中,第一金屬帶116及第二金屬帶126可為透過沖壓鎳片而形成的鎳(Ni)帶。在另一實施方式中,第一金屬帶116及第二金屬帶126可以由包含銅合金、鋁
合金或任何其他類似的材料製成。第一金屬帶116及第二金屬帶126可各具有1.5mm至3mm範圍中的寬度。此外,主體110的頂部密封膜114及底部密封膜115可為透過熱壓合而彼此貼合的兩個熱壓合膜,使得心電圖貼片100具有良好的拉伸強度。此外,頂部密封膜114、底部密封膜115、第一金屬帶116及第二金屬帶126為具有彈性的,因此心電圖貼片100具有良好的延展性。
In some embodiments, the
在較佳的實施方式中,主體110具有作為胸前導程的六個第一金屬帶116及作為標準肢導程的四個第二金屬帶126。第一金屬帶116及第二金屬帶126依照感應區119的位置及延伸部130的連接而不規則地排列。每個第一金屬帶116具有第一端117及遠離第一端117的第二端118,且第一金屬帶116的第一端117具有感應區119。也就是說,感應區119為第一金屬帶116的一部分。第一金屬帶116具有連接至感應區119的帶狀部1161。在一些實施方式中,感應區119的直徑D1大於帶狀部1161的寬度。第二金屬帶126具有第一端127及遠離第一端127的第二端128。第二金屬帶126的第一端127具有接觸區129以與延伸部130連接。此外,第一金屬帶116的第二端118及第二金屬帶126的第二端128並排排列於主體110的一端,如第3A圖所示。
In a preferred embodiment, the
由於心電圖貼片100的主體110具有位於底部密封膜115與頂部密封膜114之間的第一金屬帶116及第二金屬帶126,因此可透過沖壓與熱壓合以形成心電圖貼片100而無須進行蝕刻、顯影及銀漿印刷。如此一來,可降低心電圖貼片
100的電阻和製造成本,且可提高心電圖貼片100的品質穩定性。此外,由於第一金屬帶116的第一端117具有感應區119,因此可省略傳統心電圖的導線與電極之間之按扣連接的組裝時間及拆卸時間。根據以上,心電圖貼片100可為一次性產品且可帶來便利。此外,第二金屬帶126的第一端127具有可電性耦接至手臂或腿之延伸部130的接觸區129,將於下文中進一步描述。第一金屬帶116及第二金屬帶126之間的差異為第一端是否電性耦接至附加的金屬帶。更具體地來說,第一金屬帶116的第一端117可為從第一金屬帶116一體延伸的感應區,第二金屬帶126的第一端127配置為電性耦接至肢體導程之延伸部130的連接部分。
Since the
此外,如第3A圖及第4圖所示,主體110具有分別位於主體110的兩個相對側的第一彎曲部111a及第二彎曲部111b。舉例來說,參見第3A圖,第一彎曲部111a位於主體110的右側並定位於患者的左胸部,第二彎曲部111b位於主體110的左側並定位於患者的右胸部。在較佳的實施方式中,第一彎曲部111a由主體110的底部密封膜115、三個第一金屬帶116及頂部密封膜114界定。第一彎曲部111a中的三個第一金屬帶116的感應區119分別標記為V4、V5及V6。第二彎曲部111b由主體110的底部密封膜115、一個第一金屬帶116及頂部密封膜114界定。第一彎曲部111a中的第一金屬帶116的感應區119標記為V1。當使用心電圖貼片100時,第一彎曲部111a及第二彎曲部111b使得一些感應區119(例如第1圖的符號V1、V4、V5及V6所對應的位置)能夠根據患者身體的尺寸可
調節地貼附至患者的胸部。在本實施方式中,當從上視角度觀察時,第一彎曲部111a及第二彎曲部111b形成為U形構造,但本揭露並不以此為限。在一實施方式中,第一彎曲部111a大於第二彎曲部111b,使得心電圖貼片100有助於貼附至身型略圓潤的患者身上。
In addition, as shown in FIGS. 3A and 4, the
在另一實施方式中,如第3B圖所示,第一彎曲部111a及第二彎曲部111b形成為連續波形。換句話說,當從上視角度觀察時,第一彎曲部111a及第二彎曲部111b各形成多於一個的U形構造,且第一彎曲部111a及第二彎曲部111b之U形構造的數量為可改變的,依設計者的需求而定。在第3B圖中,第一彎曲部111a及第二彎曲部111b皆具有三個U形構造。這樣的設計使得第一彎曲部111a及第二彎曲部111b在第3B圖中的延伸範圍大於在第3A圖中的延伸範圍。
In another embodiment, as shown in FIG. 3B, the first
在一些實施方式中,心電圖貼片100還包含補強板150,補強板150配置為支撐第一金屬帶116的第二端118及第二金屬帶126的第二端128。第一金屬帶116的第一端117由對應的帶狀部1161彎曲延伸至各種位置,第一金屬帶116的第二端118及第二金屬帶126的第二端128在主體110的一端終止並對齊。由於第一金屬帶116的第二端118及第二金屬帶126的第二端128透過補強板150支撐,這樣的配置可讓心電圖偵測器容易耦接至轉接器(例如軟性印刷電路連接器)。如第3A圖所示,第一金屬帶116的第二端118及第二金屬帶126的第二端128不規則地排列在補強板150上。具體地來說,補強板150上的第二端118、128由左側至右側分別連接至RL、V1、RA、
LA、V2、V3、V4、V5、V6及LL,據此,補強板150上的第二端118、128由左側至右側的排列為128、118、128、128、118、118、118、118、118及128。換句話說,主體110內部的第一金屬帶116及第二金屬帶126的排列為126、116、126、126、116、116、116、116、116及126,但並不用以限制本揭露。
In some embodiments, the
在一些實施方式中,心電圖貼片100還包含電性耦接至主體110的延伸部130。延伸部130具有底部密封膜135、頂部密封膜134及第三金屬帶136。沿第三金屬帶136之延伸部130的剖面結構類似於沿第一金屬帶116之主體110的剖面結構,延伸部130的形成類似於主體110的形成。延伸部130的底部密封膜135及頂部密封膜134為彼此貼合的兩個熱壓合膜。此外,頂部密封膜134及底部密封膜135具有彈性。
In some embodiments, the
第三金屬帶136位於延伸部130的底部密封膜135與頂部密封膜134之間。第三金屬帶136具有第一端137及第二端138,其中第三金屬帶136的第一端137具有感應區139,且第三金屬帶136的第二端138電性耦接至主體110的第二金屬帶126的接觸區129。舉例來說,第三金屬帶136的第二端138可透過焊接以電性耦接至第二金屬帶126的接觸區129。此外,第三金屬帶136具有連接至感應區139的帶狀部1361。在一些實施方式中,感應區139的直徑D2大於帶狀部1361的寬度。在上述的較佳實施方式中,心電圖貼片100具有四個延伸部130及四個第二金屬帶126,第三金屬帶136的第二端138電性耦接至第二金屬帶126的第一端127,因此延伸部
130電性耦接至主體110。
The
應瞭解到,已敘述過的元件連接關係不再重複贅述,合先敘明。在以下敘述中,將說明心電圖貼片100的其他層及感應區119、139的結構。
It should be understood that the connection relationship of the components that has been described will not be repeated, and will be described first. In the following description, the structure of the other layers of the
第5圖繪示第4圖的局部放大圖。如第4圖及第5圖所示,主體110還包含頂表面層112、底表面層113、導電凝膠160及雙面黏膠層170。主體110的頂表面層112及底表面層113分別位於主體110的頂部密封膜114的頂面及底部密封膜115的底面上。主體110的頂表面層112可透過印刷形成對位標記140及第1圖的符號V1、V2、V3、V4、V5及V6,其中第1圖的符號V1、V2、V3、V4、V5及V6的位置分別對應於第3A圖的第一金屬帶116的感應區119的位置。在一些實施方式中,底部密封膜115的底面還可具有其他的對位標記及符號,依設計者的需求而定。
Figure 5 shows a partial enlarged view of Figure 4. As shown in FIGS. 4 and 5, the
此外,頂表面層112及底表面層113具有彈性。舉例來說,主體110的頂表面層112及底表面層113可由聚碳酸酯(polycarbonate,PC)或聚對苯二甲酸乙二酯(polyethylene terephthalate,PET)製成,但並不用以限制本揭露。
In addition, the
此外,導電凝膠160位於底表面層113的底面上且與第一金屬帶116的感應區119接觸。雙面黏膠層170位於底表面層113的底面上且圍繞導電凝膠160,如第4圖所示。當主體110貼附至患者的胸部時,導電凝膠160及雙面黏膠層170與患者的皮膚接觸。
In addition, the
此外,主體110的第一金屬帶116的感應區119為
碟形的。第一金屬帶116的感應區119具有底部123及圍繞底部123的側壁部122,且側壁部122鄰接第一金屬帶116的帶狀部1161及感應區119的底部123。
In addition, the
類似地,延伸部130還包含頂表面層132、底表面層133、導電凝膠160及雙面黏膠層170。延伸部130的頂表面層132及底表面層133分別位於延伸部130的頂部密封膜134的頂面及底部密封膜135的底面上。延伸部130的頂表面層132可透過印刷形成符號LA、RA、LL及RL,其中第1圖的符號LA、RA、LL及RL的位置分別對應於第3A圖的第三金屬帶136的感應區139的位置。此外,頂表面層132及底表面層133具有彈性,且可以由聚碳酸酯或聚對苯二甲酸乙二酯製成。
Similarly, the
導電凝膠160位於底表面層133的底面上且與第三金屬帶136的感應區139接觸。雙面黏膠層170位於底表面層133的底面上且圍繞導電凝膠160。當延伸部130貼附至患者的四肢中的其中一個時,導電凝膠160及雙面黏膠層170與患者的皮膚接觸。
The
此外,延伸部130的第三金屬帶136的感應區139為碟形,且具有與包含底部123及側壁部122的第一金屬帶116的感應區119相同的結構。
In addition, the
在以下的敘述中,將說明第3A圖之心電圖貼片100的製造方法。
In the following description, a method of manufacturing the
第6圖繪示根據本揭露一實施方式之心電圖貼片的製造方法的流程圖。此方法從步驟S1開始:由金屬片形成圖案化金屬結構,其中圖案化金屬結構具有複數個金屬帶。在 一實施方式中,透過沖壓金屬片以形成圖案化金屬結構,因此圖案化金屬結構可具有位於金屬帶之間的複數個連接部分。在另一實施方式中,透過蝕刻金屬片形成不具有金屬帶之間之連接部分的圖案化金屬結構。此方法持續進行至步驟S2:熱壓合底部密封膜、圖案化金屬結構及頂部密封膜。 FIG. 6 shows a flowchart of a method for manufacturing an electrocardiogram patch according to an embodiment of the present disclosure. The method starts from step S1: forming a patterned metal structure from a metal sheet, wherein the patterned metal structure has a plurality of metal strips. exist In one embodiment, the patterned metal structure is formed by stamping the metal sheet, so the patterned metal structure may have a plurality of connecting parts between the metal strips. In another embodiment, a patterned metal structure without connecting portions between metal strips is formed by etching a metal sheet. The method continues to step S2: thermocompressing the bottom sealing film, the patterned metal structure, and the top sealing film.
在一些實施方式中,金屬片可為鎳片。透過沖壓以對金屬片進行圖案化之後,圖案化的金屬片可形成透過連接部分彼此連接的金屬帶。隨後,熱壓合第4圖的底部密封膜115、圖案化金屬結構及第4圖的頂部密封膜114。在第4圖的圖案化金屬結構透過底部密封膜115及頂部密封膜114密封之後,圖案化金屬片的連接部分被切割(例如沖壓)以彼此分離,進而在剩餘的連接部分之間形成間隙。如此一來,便形成第3A圖的第一金屬帶116及第二金屬帶126,且第一金屬帶116及第二金屬帶126彼此電性分離。
In some embodiments, the metal sheet may be a nickel sheet. After the metal sheet is patterned by stamping, the patterned metal sheet can form a metal strip connected to each other through the connecting portion. Subsequently, the
此外,形成第3A圖的第一金屬帶116及第二金屬帶126之後,第4圖的頂表面層112及底表面層113可分別貼附至第4圖的頂部密封膜114的頂面及底部密封膜115的底面,如此一來便可以獲得第3A圖的心電圖貼片100。
In addition, after forming the
第7圖繪示根據本揭露一實施方式之心電圖貼片100a的上視圖。心電圖貼片100a包含主體110a及電性連接至主體110a的四個延伸部130a。主體110a的結構類似於上述之主體110的結構,且延伸部130a的結構類似於上述之延伸部130的結構。本實施方式與第1圖所示的實施方式不同之處在於心電圖貼片100a還包含第一離形紙180a及兩個第二離形紙
180b、180c。第一離形紙180a貼附至主體110a的底側。第二離形紙180b與第一離形紙180a的上邊緣相鄰,且貼附至兩個上方延伸部130a的底側。此外,第二離形紙180c與第一離形紙180a的下邊緣相鄰,且貼附至兩個下方延伸部130a的底側。舉例來說,第一離形紙180a及第二離形紙180b、180c位於下方且貼附至第4圖的導電凝膠160及雙面黏膠層170。
FIG. 7 shows a top view of the
當欲使用心電圖貼片100a時,使用者沿第一離形紙180a與第二離形紙180b之間的虛線L1及第一離形紙180a與第二離形紙180c之間的虛線L2,撕開第一離形紙180a,接著撕開第二離形紙180b、180c的其中一張,隨後撕開第二離形紙180b、180c中的另一張。在本實施方式中,虛線L1及L2可具有郵票孔(stamp hole,亦稱折斷孔)。在另一實施方式中,虛線L1可為第一離形紙180a與第二離形紙180b之間的小間隙,且虛線L2可為第一離形紙180a及第二離形紙180c之間的小間隙。
When the
此外,主體110a還可具有虛線L3、L4及L5,使得主體110a的一些感應區119a可被集中於離形紙上,以便在使用之前容易定位於第一離形紙180a上。當使用心電圖貼片100a時,使用者可以決定感應區119a(例如符號V1、V2、V3及V4)是否沿虛線L3、L4及L5撕開,以依照患者身體的尺寸調整感應區119a的位置。在本實施方式中,虛線L3、L4及L5可為用於可拆卸連接的沖壓孔。
In addition, the main body 110a may also have dotted lines L3, L4, and L5, so that some
雖然本揭露已以實施方式揭露如上,然其並非用以限定本揭露,任何熟習此技藝者,在不脫離本揭露之精神和 範圍內,當可作各種之更動與潤飾,因此本揭露之保護範圍當視後附之申請專利範圍所界定者為準。 Although this disclosure has been disclosed as above in the implementation manner, it is not intended to limit this disclosure. Anyone who is familiar with this technique will not deviate from the spirit and spirit of this disclosure. Within the scope, various changes and modifications can be made. Therefore, the protection scope of this disclosure shall be subject to the scope of the attached patent application.
100‧‧‧心電圖貼片 100‧‧‧ECG Patch
110‧‧‧主體 110‧‧‧Main body
111a‧‧‧第一彎曲部 111a‧‧‧First bending part
111b‧‧‧第二彎曲部 111b‧‧‧Second bending part
112‧‧‧頂表面層 112‧‧‧Top surface layer
119‧‧‧感應區 119‧‧‧Induction zone
130‧‧‧延伸部 130‧‧‧Extension
132‧‧‧頂表面層 132‧‧‧Top surface layer
139‧‧‧感應區 139‧‧‧Induction zone
140‧‧‧對位標記 140‧‧‧Registration mark
150‧‧‧補強板 150‧‧‧Reinforcing plate
4-4、4’-4’‧‧‧線段 4-4, 4’-4’‧‧‧ line segment
V1~V6‧‧‧符號 V1~V6‧‧‧Symbol
RA、RL、LA、LL‧‧‧符號 RA, RL, LA, LL‧‧‧ symbols
Claims (19)
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WOPCT/US2019/015532 | 2019-01-29 |
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TWM551476U (en) * | 2017-08-30 | 2017-11-11 | 宇心生醫股份有限公司 | Device for obtaining ECG |
CN109009081A (en) * | 2017-06-09 | 2018-12-18 | 美商宇心生医股份有限公司 | Integrated ECG electrode patch |
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EP1050269A1 (en) * | 1999-05-07 | 2000-11-08 | Nessler Medizintechnik GmbH & Co KG | Multiple-contact electrode |
JP3534405B1 (en) * | 2002-11-28 | 2004-06-07 | 鐘淵化学工業株式会社 | Method for producing heat-resistant flexible laminate and heat-resistant flexible laminate produced thereby |
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CN109009081A (en) * | 2017-06-09 | 2018-12-18 | 美商宇心生医股份有限公司 | Integrated ECG electrode patch |
TWM551476U (en) * | 2017-08-30 | 2017-11-11 | 宇心生醫股份有限公司 | Device for obtaining ECG |
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TW202027676A (en) | 2020-08-01 |
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