WO2020159472A1

WO2020159472A1 - Electrocardiography patch and method of manufacturing the same

Info

Publication number: WO2020159472A1
Application number: PCT/US2019/015532
Authority: WO
Inventors: Tzu-Chih Lin; Yu-Chen Huang; Kun-Hsi Tsai; Ching-Heng Lin
Original assignee: Vitalchains Corporation
Priority date: 2019-01-29
Filing date: 2019-01-29
Publication date: 2020-08-06
Also published as: TWI742368B; TW202027676A

Abstract

An electrocardiography (ECG) patch includes a main body that has a bottom sealing film, a top sealing film, at least one first metal strip, and at least one second metal strip. The first and second metal strips are between the bottom sealing film and the top sealing film. Each of the first and second metal strips has a first end and a second end. The first end of the first metal strip has a sensing region, and the first end of the second metal strip has a contact region.

Description

ELECTROCARDIOGRAPHY PATCH AND METHOD OF MANUFACTURING

THE SAME

BACKGROUND

Field of Invention

[0001] The present invention relates to an electrocardiography patch and a method of the electrocardiography patch.

Description of Related Art

[0002] Electrocardiograph (ECG) monitors are widely used to obtain medical (i.e. , biopotential) signals containing information indicative of the electrical activity associated with the heart and pulmonary system. To obtain medical signals, ECG electrodes are applied to the skin of a patient in various locations. The electrodes, after being positioned on the patient, are coupled to an ECG monitor by a set of ECG lead wires. The distal ends of the ECG lead wires may include connectors which are coupled to the electrodes through press studs to receive medical signals from the body. The proximal ends of the ECG lead wires are coupled to the ECG monitor through an adapter, and supply the medical signals received from the body to the ECG monitor.

[0003] A traditional ECG assembly including electrodes and lead wires may be manufactured by a method similar to the formation of a flexible printed circuit (FPC), such as a etch process and a development process. Alternatively, the ECG assembly may be manufactured by printing with silver paste.

[0004] However, the aforementioned conventional methods cause the high cost of the ECG assembly, and using the silver paste printing may degrade the quality stability of the ECG assembly. In addition, there are two types of ECG assemblies including an adjustable (no positioning) type and a non-adjustable (positioning) type. The position of the adjustable type ECG assembly may be adjusted through stretching, but only professional users can operate the adjustable type ECG assembly. The position of the non-adjustable type ECG assembly may not be adjusted for measurement based on the size of a patient's body.

SUMMARY

[0005] An aspect of the present invention is to provide an electrocardiography (ECG) patch.

[0006] According to an embodiment of the present invention, an electrocardiography patch includes a main body that has a bottom sealing film, a top sealing film, at least one first metal strip, and at least one second metal strip. The first and second metal strips are between the bottom sealing film and the top sealing film. Each of the first and second metal strips has a first end and a second end. The first end of the first metal strip has an sensing region, and the first end of the second metal strip has a contact region.

[0007] An aspect of the present invention is to provide a method of manufacturing an electrocardiography (ECG) patch.

[0008] According to an embodiment of the present invention, a method of manufacturing an electrocardiography patch includes forming a patterned metal structure from a metal plate, wherein the patterned metal structure has a plurality of metal strips; and thermally laminating a bottom sealing film, the patterned metal structure, and a top sealing film.

[0009] In the aforementioned embodiments of the present invention, because the main body of the ECG patch has the first and second metal strips that are between the bottom sealing film and the top sealing film, the ECG patch can be formed by punching and thermally laminating without etching, developing, and silver paste printing. Therefore, the resistance and the manufacturing cost of the ECG patch can be reduced, and the quality stability of the ECG patch can be improved. Further, since the first end of the first metal strip has the sensing region, assembly time and disassembly time for connection with press studs between traditional ECG lead wires and electrodes can be omitted. Moreover, the first end of the second metal strip has the contact region capable of electrically coupling an extending part for an arm or a leg. In addition, due to the second ends of the first and second metal strips arranged side by side, such a configuration may be easily coupled to an adapter (e.g., FPC connector) of an ECG monitor.

[0010] It is to be understood that both the foregoing general description and the following detailed description are by examples, and are intended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The invention can be more fully understood by reading the following detailed description of the embodiments, with reference made to the accompanying drawings as follows: [0012] Fig. 1 is a top view of an electrocardiography (ECG) patch according to one embodiment of the present invention;

[0013] Fig. 2 is a schematic view of positions of sensing regions of the ECG patch of Fig. 1 when the sensing regions are attached to a patient's body;

[0014] Fig. 3A is a schematic view of the inner structure of the ECG patch of Fig. 1 ;

[0015] Fig. 3B is a schematic view of another embodiment different from Fig. 3A;

[0016] Fig. 4 is a cross-sectional view of the ECG patch taken along line 4-4 or line 4’ -4’ of Fig. 1 ;

[0017] Fig. 5 is a partially enlarged view of Fig. 4;

[0018] Fig. 6 is a flow chart of a method of manufacturing an ECG patch according to one embodiment of the present invention; and

[0019] Fig. 7 is a top view of an electrocardiography (ECG) patch according to one embodiment of the present invention.

DETAILED DESCRIPTION

[0020] Reference will now be made in detail to the present embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used in the drawings and the description to refer to the same or like parts.

[0021] Fig. 1 is a top view of an electrocardiography (ECG) patch 100 according to one embodiment of the present invention. Fig. 2 is a schematic view of positions of sensing regions 1 19 and 139 of the ECG patch 100 of Fig. 1 when the sensing regions 1 19 and 139 are attached to a patient's body. As shown in Fig. 1 and Fig. 2, the ECG patch 100 includes a flexible main body 1 10 and at least one flexible extending part 130. The extending part 130 is electrically coupled to the main body 1 10. In the preferred embodiments, the flexible main body 1 10 can be as precordial lead, and the extending part 130 can be as standard limb lead. The flexible main body 110 may be covered onto the patient’s chest. In the preferred embodiments, the ECG patch 100 includes four extending parts 130, and each of the extending parts 130 has one sensing region 139, such as positions of symbols LA, RA, LL, and RL. Moreover, the main body 1 10 has six sensing regions 1 19, such as positions of symbols V1 , V2, V3, V4, V5, and V6. In the below context, those ten symbols are used to described as various positions, respectively.

[0022] When the ECG patch 100 is in use, the four sensing regions 139 of the extending parts 130 may be respectively attached to the patient's four limbs at the wrists and ankles, and the six sensing regions 1 19 of the main body 1 10 may be attached in standard positions on the chest around the heart of the patient, as shown in Fig. 2. The ECG patch 100 may be used as a standard twelve-lead ECG patch with ten electrodes. In the preferred embodiment, four sensing regions 139 of the extending parts 130 may be positioned onto the right shoulder, left shoulder, right pelvis and left pelvis, alternatively. However, the present invention is not limited to the number of the sensing regions 1 19 and the number of the sensing regions 139, and each of the numbers can be decided by designers as they deem necessary. [0023] In some embodiments, the main body 1 10 further has an alignment mark 140, which is like cross-shaped. When the main body 1 10 of the ECG patch 100 is attached to the patient's body, the horizontal line of the alignment mark 140 may be positioned on the 4^th rib intercostal space which is aligned with nipples so that V1 and V2 are in the same line between two nipples, and the vertical line of the alignment mark 140 may be aligned with the central line of the patient's body.

[0024] In the following description, the structure of the ECG patch 100 of Fig. 1 will be described in detail.

[0025] Fig. 3A is a schematic view of the inner structure of the ECG patch 100 of Fig. 1 . Fig. 4 is a cross-sectional view of the ECG patch 100 taken along line 4-4 or 4’-4’ of Fig. 1 . As shown in Fig. 3A and Fig. 4, the main body 1 10 has a top sealing film 1 14, a bottom sealing film 1 15, at least one first metal strip 1 16, and at least one second metal strip 126. The first and second metal strips 1 16 and 126 are located between the bottom sealing film 1 15 and the top sealing film 1 14, and are used as conductive traces to replace traditional ECG lead wires.

[0026] In some embodiments, the first and second metal strips 1 16 and 126 may be nickel (Ni) strips that are formed by punching a nickel plate. In another embodiment, the first metal strip 1 16 and second metal strips 126 may be made of copper alloy or aluminum alloy, or any other material like that. Each of the first and second metal strips 1 16 and 126 may have a width in a range from 1.5 mm to 3 mm. Further, the top sealing film 1 14 and the bottom sealing film 1 15 of the main body 1 10 may be two thermal lamination films that are bonded with each other by thermally laminating, such that the ECG patch 100 has good tensile strength. In addition, the top sealing film 1 14, the bottom sealing film 1 15, and the first and second metal strips 1 16 and 126 are flexible, and thus the ECG patch 100 has good extensibility.

[0027] In the preferred embodiment, the main body 1 10 has six first metal strips 1 16 for precordial leads and four second metal strips 126 for standard limb leads. The first metal strips 1 16 and the second metal strips 126 are arranged irregularly based on the positions of the sensing regions 1 19 and the connection of the extending parts 130. Each first metal strip 1 16 has a first end 1 17 and a second end 1 18 distal to the first end 1 17. The first end 1 17 of the first metal strip 1 16 has the sensing region 1 19. That is, the sensing region 1 19 is a portion of the first metal strip 1 16. The first metal strip 1 16 has a strip portion 1 161 connected to the sensing region 1 19. In some embodiments, the sensing region 1 19 has a diameter D1 greater than the width of the strip portion 1 161. The second metal strip 126 has a first end 127 and a second end 128 distal to the first end 127. The first end 127 of the second metal strip 126 has a contact region 129 to connect the extending part 130. In addition, the second end 1 18 of the first metal strip 1 16 and the second end 128 of second metal strip 126 are arranged side by side at an end of the main body 1 10, as shown in Fig. 3A.

[0028] Because the main body 1 10 of the ECG patch 100 has the first and second metal strips 1 16 and 126 that are between the bottom sealing film 1 15 and the top sealing film 1 14, the ECG patch 100 can be formed by punching and thermally laminating without etching, developing, and silver paste printing. Therefore, the resistance and the manufacturing cost of the ECG patch 100 can be reduced, and the quality stability of the ECG patch 100 can be improved. Further, since the first end 1 17 of the first metal strip 1 16 has the sensing region 1 19, assembly time and disassembly time for connection with press studs between traditional ECG lead wires and electrodes can be omitted. Accordingly, the ECG patch 100 may be a disposable product and brings convenience. Moreover, the first end 127 of the second metal strip 126 has the contact region 129 capable of electrically coupling the extending part 130 for an arm or a leg, which will be described further below. The difference between the first metal strip 1 16 and the second metal strip 126 is first end whether electrically coupled addition metal strip or not. More specifically, the first end 1 17 of the first metal strip 1 16 is sensing region which may be extended integrally from thereof, the first end 127 of the second metal strip 126 is connecting part which is configured to electrically couple the extending part 130 for limb leads.

[0029] As shown in Fig. 3A and Fig. 4, moreover, the main body 1 10 has a first bending portion 1 1 1 a and a second bending portion 1 1 1 b that are respectively at two opposite sides of the main body 1 10. For example, viewing Fig. 3A, the first bending portion 1 1 1 a is located at the right side of the main body 1 10 and positioned onto the left chest of patient, and the second bending portion 1 1 1 b is located at the left side of the main body 1 10 and positioned onto the right chest of patient. In the preferred embodiment, the first bending portion 1 1 1 a is defined by the bottom sealing film 1 15, three of the first metal strips 1 16, and the top sealing film 1 14 of the main body 1 10. Those sensing regions 1 19 of three of the first metal strips 1 16 in the first bending portion 1 1 1 a are labeled as V4, V5 and V6, respectively. The second bending portion 1 1 1 b is defined by the bottom sealing film 115, one of first metal strip 116, and the top sealing film 114 of the main body 110. The sensing region 119 of one of the first metal strip 116 in the first bending portion 111a is labeled as V1. When the ECG patch 100 is in use, the first and second bending portions 111a and 111b enable some sensing regions 119 (e.g., the corresponding positions of the symbols V1, V4, V5, and V6 of Fig.1) to be adjustably attached to a chest of a patient based on the size of the patient's body. In this embodiment, the first and second bending portions 111a and 111b form a U-shaped configuration when viewed from above, but the present invention is not limited in this regard. In an embodiment, the first bending portion 111a is bigger than the second bending portion 111b, which is contributed the patch 100 to be attached onto chubby patients.

[0030] In another embodiment, as shown in Fig.3B, the first bending portion 111a and the second bending portion 111b are formed as continuous waves. In other words, each of the first and second bending portions 111a and 111b forms more than one U-shaped configuration when viewed from above, and the number of the U-shaped configurations of the first and second bending portions 111a and 111b may be varied as deemed necessary by designers. In Fig.3B, the first and second bending portions 111a and 111b both have three U-shaped configurations. As a result of such a design, extending ranges of the first and second bending portions 111a and 111 b of Fig.3B are greater than that of Fig. 3A.

[0031] In some embodiments, the ECG patch 100 further includes a reinforcing plate 150 configured to support the second ends 118 and 128 of the first and second metal strips 116 and 126. The first ends 117 of the first metal strips 1 16 extend curvedly from respective strip portion 1 161 to position variously, while the second ends 1 18 of the first metal strips 116 and the second ends 128 of the second metal strips 126 are terminated and aligned at an end of the main body 1 10. Since the second ends 1 18 and 128 of the first and second metal strips 1 16 and 126 are supported by the reinforcing plate 150, such a configuration may be easily coupled to an adapter (e.g., FPC connector) of an ECG monitor. As shown in Fig. 3A, the second ends 1 18 of the first metal strips 1 16 and the second ends 128 of the second metal strips 126 are arranged irregularly on the reinforcing plate 150. Specifically, the second ends 1 18 and 128 on the reinforcing plate 150 from left side to right side are respectively connected to RL, V1 , RA, LA, V2, V3, V4, V5, V6, LL. The arrangement of the second ends 1 18 and 128 on the reinforcing plate 150 from left side to right side is 128, 1 18, 128, 128, 1 18, 1 18, 1 18, 1 18, 1 18, and 128. In other words, the arrangement of the first and second metal strips 1 16 and 126 of the inner portion of the main body 1 10 from left side to right side is 126, 1 16, 126, 126, 1 16, 1 16, 1 16, 1 16, 1 16, and 126, but the present invention is not limited in this regard.

[0032] In some embodiments, the ECG patch 100 further includes the extending part 130 electrically coupled to the main body 1 10. The extending part 130 has a bottom sealing film 135, a top sealing film 134, and a third metal strip 136. The cross-sectional structure of the extending part 130 along the third metal strip 136 is similar to that of the main body 1 10 along the first metal strip 1 16, and the formation of the extending part 130 is similar to that of the main body 1 10. The bottom sealing film 135 and the top sealing film 134 of the extending part 130 are two thermal lamination films bonded with each other. In addition, the top sealing film 134 and the bottom sealing film 135 are flexible.

[0033] The third metal strip 136 is between the bottom sealing film 135 and the top sealing film 134 of the extending part 130. The third metal strip 136 has a first end 137 and a second end 138, in which the first end 137 of the third metal strip 136 has an sensing region 139, and the second end 138 of the third metal strip 136 is electrically coupled to the contact region 129 of the second metal strip 126 of the main body 1 10. For example, the second end 138 of the third metal strip 136 may be electrically coupled to the contact region 129 of the second metal strip 126 by soldering. Furthermore, the third metal strip 136 has a strip portion 1361 connected to the sensing region 139. In some embodiments, the sensing region 139 has a diameter D2 greater than the width of the strip portion 1361. In the preferred embodiment above, the ECG patch 100 has four extending parts 130 and four second metal strip, each of second end 138 of the third metal strip 136 is electrically coupled to the first end 127 of the second metal strip 126, therefore the extending parts 130 are electrically coupled to the main body 1 10.

[0034] It is to be noted that the connection relationships of the elements described above will not be repeated in the following description. In the following description, other layers of the ECG patch 100 and the structures of the sensing regions 1 19 and 139 will be described.

[0035] Fig. 5 is a partially enlarged view of Fig. 4. As shown in Fig. 4 and Fig. 5, the main body 1 10 further includes a top surface layer 1 12, a bottom surface layer 1 13, a conductive gel 160, and a double-sided adhesive layer 170. The top surface layer 1 12 and the bottom surface layer 1 13 of the main body 1 10 respectively on the top surface of the top sealing film 114 and the bottom surface of the bottom sealing film 1 15 of the main body 1 10. The top surface layer 1 12 of the main body 1 10 may have the alignment mark 140 and the symbols V1 , V2, V3, V4, V5, and V6 of Fig. 1 by printing, in which the symbols V1 , V2, V3, V4, V5, and V6 of Fig. 1 respectively correspond to the sensing regions 1 19 of the first metal strip 1 16 of Fig. 3A in position. In some embodiments, the bottom surface of the bottom sealing film 1 15 may also have other alignment mark and symbols as deemed necessary by designers.

[0036] In addition, the top surface layer 1 12 and the bottom surface layer 1 13 are flexible. For example, the top surface layer 1 12 and the bottom surface layer 1 13 of the main body 1 10 may be made of polycarbonate (PC) or polyethylene terephthalate (PET), but the present invention is not limited in this regard.

[0037] Moreover, the conductive gel 160 is on the bottom surface of the bottom surface layer 1 13 and is in contact with the sensing region 1 19 of the first metal strip 1 16. The double-sided adhesive layer 170 is on the bottom surface of the bottom surface layer 1 13 and surrounds the conductive gel 160, as shown in Fig. 4. When the main body 1 10 is attached to a chest of a patient, the conductive gel 160 and the double-sided adhesive layer 170 are in contact with the skin of the patient.

[0038] In addition, the sensing region 1 19 of the first metal strip 1 16 of the main body 1 10 is dish-shaped. The sensing region 1 19 of the first metal strip 1 16 has a bottom portion 123 and a sidewall portion 122 surrounding the bottom portion 123, and the sidewall portion 122 adjoins the strip portion 1 161 of the first metal strip 1 16 and the bottom portion 123 of the sensing region 1 19.

[0039] Similarly, the extending part 130 further includes a top surface layer 132, a bottom surface layer 133, the conductive gel 160, and the double-sided adhesive layer 170. The top surface layer 132 and the bottom surface layer 133 of the extending part 130 respectively on the top surface of the top sealing film 134 and the bottom surface of the bottom sealing film 135 of the extending part 130. The top surface layer 132 of the extending part 130 may have the symbols LA, RA, LL, and RL of Fig. 1 by printing, in which the symbols LA, RA, LL, and RL of Fig. 1 respectively correspond to the sensing regions 139 of the third metal strip 136 of Fig. 3A in position. In addition, the top surface layer 132 and the bottom surface layer 133 are flexible and may be made of polycarbonate (PC) or polyethylene terephthalate (PET).

[0040] The conductive gel 160 is on the bottom surface of the bottom surface layer 133 and is in contact with the sensing region 139 of the third metal strip 136. The double-sided adhesive layer 170 is on the bottom surface of the bottom surface layer 133 and surrounds the conductive gel 160. When the extending part 130 is attached to one of limbs of a patient, the conductive gel 160 and the double-sided adhesive layer 170 are in contact with the skin of the patient.

[0041] Moreover, the sensing region 139 of the third metal strip 136 of the extending part 130 is dish-shaped, and has the same structure as the sensing region 1 19 of the first metal strip 1 16 including the bottom portion 123 and the sidewall portion 122. [0042] In the following description, a method of manufacturing the ECG patch 100 of Fig. 3A will be described.

[0043] Fig. 6 is a flow chart of a method of manufacturing an ECG patch according to one embodiment of the present invention. The method begins with step S1 in which a patterned metal structure is formed from a metal plate, in which the patterned metal structure has a plurality of metal strips. In one embodiment, the patterned metal structure is formed by punching the metal plate, and thus the patterned metal structure may have a plurality of connection portions between the metal strips. In another embodiment, the patterned metal structure without the connection portions between the metal strips is formed by etching the metal plate. The method continues with step S2 in which a bottom sealing film, the patterned metal structure, and a top sealing film are thermally laminated.

[0044] In some embodiments, the metal plate may be a nickel plate. After the metal plate is patterned by punching, the patterned metal plate may form the metal strips connected with each other through the connection portions. Thereafter, the bottom sealing film 1 15 of Fig. 4, the patterned metal structure, and the top sealing film 1 14 of Fig. 4 are thermally laminated. After the patterned metal structure are sealed by the bottom sealing film 1 15 and the top sealing film 1 14 of Fig. 4, the connection portions of the patterned metal plate are cut (e.g., punching) to separate from each other, thereby forming gaps between the remaining connection portions. As a result, the first and second metal strips 1 16 and 126 of Fig. 3A are formed, and are electrically isolated from each other. [0045] Moreover, after the first and second metal strips 1 16 and 126 of Fig. 3A are formed, the top surface layer 1 12 and the bottom surface layer 1 13 of Fig. 4 may be respectively adhere to the top surface of the top sealing film 1 14 and the bottom surface of the bottom sealing film 1 15 of Fig. 4, and thus the ECG patch 100 of Fig. 3A can be obtained.

[0046] Fig. 7 is a top view of an electrocardiography (ECG) patch 100a according to one embodiment of the present invention. The ECG patch 100a includes a main body 1 10a and four extending parts 130a electrically connected to the main body 1 10a. The structure of the main body 1 10a is similar to that of the aforementioned main body 1 10, and the structure of the extending part 130a is similar to that of the aforementioned extending part 130. The difference between this embodiment and the embodiment shown in Fig. 1 is that the ECG patch 100a further includes a first release paper 180a and two second release papers 180b and 180c. The first release paper 180a is adhered to a bottom side of the main body 1 10a. The second release papers 180b is adjacent to an upper edge of the first release paper 180a, and is adhered to bottom sides of two upper extending parts 130a. Moreover, the second release papers 180c is adjacent to a lower edge of the first release paper 180a, and is adhered to bottom sides of two lower extending parts 130a. For example, the first release paper 180a and the second release papers 180b and 180c are below and adhered to the conductive gel 160 and the double-sided adhesive layer 170 of Fig. 4.

[0047] When the ECG patch 100a is in use, users can tear the first release paper 180a first, and then tear one of the second release papers 180b and 180c, and then tear the other second release paper 180b or 180c. Moreover, dotted line L1 between the first and second release papers180a and 180b and dotted line L2 between the first and second release papers 180a and 180c can result in convenience when users tear the first and second release papers 180a, 180b, and 180c. In this embodiment, the dotted lines L1 and L2 may have stamp holes. In another embodiment, the dotted line L1 may be a small gap between the first release paper 180a and the second release paper 180b, and the dotted line L2 may be a small gap between the first release paper 180a and the second release paper 180c.

[0048] In addition, the main body 1 10a may further have dotted lines L3, L4, and L5, such that some sensing regions 1 19a of the main body 1 10a can be concentrated so as to be easily positioned on the first release paper 180a before use. When the ECG patch 100a is in use, users can determine whether the sensing regions 1 19a (e.g., the symbols V1 , V2, V3, V4) are teared along the dotted lines L3, L4, and L5 for adjusting their positions based on the size of a patient's body. In this embodiment, the dotted lines L3, L4, and L5 may have stamp holes for detachable connection.

[0049] Although the present invention has been described in considerable detail with reference to certain embodiments thereof, other embodiments are possible. Therefore, the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.

[0050] It will be apparent to those skilled in the art that various modifications and variations can be made to the structure of the present invention without departing from the scope or spirit of the invention. In view of the foregoing, it is intended that the present invention covers modifications and variations of this invention provided they fall within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. An electrocardiography (ECG) patch, comprising:

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, wherein the first and second metal strips are between the bottom sealing film and the top sealing film, each of the first and second metal strips has a first end and a second end, the first end of the first metal strip has an sensing region, the first end of the second metal strip has a contact region.

2. The electrocardiography patch of claim 1 , wherein the main body has a first bending portion at one side of the main body, and the first bending portion is defined by the bottom sealing film, at least three of the first metal strips, and the top sealing film of the main body.

3. The electrocardiography patch of claim 2, wherein the main body has a second bending portion, which is defined by one of the first metal strips, the bottom sealing film, and the top sealing film of the main body, and the first and second bending portions are respectively at two opposite sides of the main body.

4. The electrocardiography patch of claim 1 , wherein each of the first metal strips and the second metal strip of the main body has a width with 1.5-3 mm.

5. The electrocardiography patch of claim 1 , wherein the main body has six the first metal strips and four the second metal strips, and the first metal strips and the second metal strips are arranged irregularly.

6. The electrocardiography patch of claim 1 , the main body further comprises:

a top surface layer and a bottom surface layer respectively on a top surface of the top sealing film and a bottom surface of the bottom sealing film of the main body, wherein the top surface layer has an alignment mark and a symbol, and the symbol corresponds to the sensing region of the first metal strip in position;

a conductive gel on a bottom surface of the bottom surface layer and in contact with the sensing region of the first metal strip; and

a double-sided adhesive layer on the bottom surface of the bottom surface layer and surrounding the conductive gel.

7. The electrocardiography patch of claim 1 , wherein the bottom sealing film and the top sealing film of the main body are two thermal lamination films bonded with each other.

8. The electrocardiography patch of claim 1 , further comprising:

at least one extending part having a bottom sealing film, a top sealing film, and a third metal strip, wherein the third metal strip is between the bottom sealing film and the top sealing film of the extending part, the third metal strip has a first end and a second end, the first end of the third metal strip has an sensing region, and the second end of the third metal strip is electrically coupled to the contact region of the second metal strip.

9. The electrocardiography patch of claim 8, wherein the sensing region of the first metal strip of the main body and the sensing region of the third metal strip of the extending part are dish-shaped.

10. The electrocardiography patch of claim 8, wherein each of the first metal strip of the main body and the third metal strip of the extending part has a strip portion, and each of the sensing region of the first metal strip and the sensing region of the third metal strip has a bottom portion and a sidewall portion surrounding the bottom portion, and the sidewall portion adjoins the strip portion and the bottom portion.

1 1. The electrocardiography patch of claim 10, wherein the sensing region of the first metal strip has a diameter greater than a width of the strip portion of the first metal strip, and the sensing region of the third metal strip has a diameter greater than a width of the strip portion of the third metal strip.

12. The electrocardiography patch of claim 8, the extending part further comprises:

a top surface layer and a bottom surface layer respectively on a top surface of the top sealing film and a bottom surface of the bottom sealing film of the extending part, wherein the top surface layer has a symbol corresponding to the sensing region of the third metal strip in position; a conductive gel on a bottom surface of the bottom surface layer and in contact with the sensing region of the third metal strip; and

13. The electrocardiography patch of claim 8, wherein the bottom sealing film and the top sealing film of the extending part are two thermal lamination films bonded with each other.

14. The electrocardiography patch of claim 8, further comprising:

a first release paper adhered to a bottom side of the main body; and at least one second release paper adjacent to an edge of the first release paper, and adhered to a bottom side of the extending part.

15. The electrocardiography patch of claim 1 , further comprising:

a reinforcing plate is configured to support the second ends of the first and second metal strips, wherein the second ends of the first metal strip and the second metal strip are terminated and aligned at an end of the main body.

16. A method of manufacturing an electrocardiography (ECG) patch, the method comprising:

forming a patterned metal structure from a metal plate, wherein the patterned metal structure has a plurality of metal strips; and

thermally laminating a bottom sealing film, the patterned metal structure, and a top sealing film.

17. The method of manufacturing the electrocardiography patch of claim 16, further comprising:

adhering a top surface layer and a bottom surface layer to a top surface of the top sealing film and a bottom surface of the bottom sealing film, respectively.

18. The method of manufacturing the electrocardiography patch of claim 16, wherein forming the patterned metal structure from the metal plate further comprises:

punching the metal plate to form the patterned metal structure, wherein the patterned metal structure has a plurality of connection portions between the metal strips.

19. The method of manufacturing the electrocardiography patch of claim 18, further comprising:

cutting the connection portions after punching the metal plate such that the metal strips are electrically isolated from each other.

20. The method of manufacturing the electrocardiography patch of claim 16, wherein forming the patterned metal structure from the metal plate further comprises:

etching the metal plate to form the patterned metal structure.