Electrocardiogram (ECG) detection device and its preparation method

Abstract

This invention relates to an electrocardiogram (ECG) detection device and its preparation method. The ECG detection device includes an ECG sensing patch and a detection circuit. The ECG sensing patch includes: a bottom protective film; ECG electrodes, located on the bottom protective film, comprising a double-sided conductive fabric layer and a metal conductive film layer, with the metal conductive film layer located at the center of the double-sided conductive fabric layer; a stretch film layer, located above the ECG electrodes, comprising an adhesive layer, an extension layer, and through-holes penetrating the adhesive layer and the extension layer, the through-holes being aligned with the metal conductive film layer; a stress control film layer, located above the stretch film layer, including a first interface for electrical connection with the detection circuit; stretch leads, filling the through-holes, with one end of the stretch leads electrically connected to the ECG electrodes and the other end electrically connected to the first interface; and a top protective film. This invention improves the biocompatibility of the ECG detection device with the skin surface and the adhesion between the ECG electrodes and the stretch film layer, thereby improving the detection reliability and accuracy of the ECG detection device.

Description

Technical Field

[0001] This invention relates to the field of electrocardiogram (ECG) sensing technology, and more particularly to an ECG detection device and its preparation method. Background Technology

[0002] With the fast pace of modern life and the aging population, cardiovascular diseases have become a significant health threat. The diagnosis, treatment, and pathological research of cardiovascular diseases all require the assistance of electrocardiogram (ECG) monitoring. Different cardiovascular diseases present with different ECG abnormalities, and in particular, long-term ECG monitoring can reveal more health information.

[0003] Currently, in the process of electrocardiogram (ECG) signal monitoring, Ag / AgCl wet electrodes are commonly placed on the patient's skin. A large ECG transducer reads the surface potential to generate an ECG. Because these large transducers typically use long shielded wires to connect the transducer chip to individual electrodes placed at different locations on the skin, the patient cannot move freely or leave the hospital for testing, thus reducing the user experience. Furthermore, Ag / AgCl wet electrodes usually utilize conductive adhesive to enhance their electrical contact with the skin; however, prolonged contact between the adhesive layer of the Ag / AgCl wet electrode and the skin can cause redness and / or itching. Additionally, the non-stretchability of the Ag / AgCl wet electrode hinders normal skin stretching during movement, resulting in poor wearing comfort. To address the issues of skin allergies and wearing comfort associated with adhesive fixatives, a stretchable ECG patch film using adhesive silicone as the adhesive layer offers better compatibility and wearing comfort. Since the distance between ECG electrodes needs to be greater than a certain value, using a larger ECG patch can meet the requirements for electrode spacing and skin adhesion. However, the adhesiveness of silicone itself is limited, resulting in weak fixation of planar ECG electrodes. This leads to insufficient adhesion of the electrodes to the ECG patch, causing separation of the electrodes from the patch film and failure of electrical connections.

[0004] Therefore, improving the ease of use of ECG monitoring devices and enhancing their reliability and accuracy are pressing technical issues that need to be addressed. Summary of the Invention

[0005] This invention provides an electrocardiogram (ECG) detection device and its preparation method, which improves the ease of use of the ECG detection device and enhances its detection reliability and accuracy.

[0006] To address the above problems, the present invention provides an electrocardiogram (ECG) detection device, comprising an ECG sensing patch and a detection circuit; wherein, the ECG sensing patch comprises:

[0007] Underlying protective film;

[0008] The electrocardiogram (ECG) electrode is located on the bottom protective film. The ECG electrode includes a double-sided conductive fabric layer and a metal conductive film layer located on the surface of the double-sided conductive fabric layer. The metal conductive film layer is located at the center of the double-sided conductive fabric layer.

[0009] A stretchable film layer is located above the ECG electrode. The stretchable film layer includes an adhesive layer, an extension layer located above the adhesive layer, and a through hole that continuously penetrates the adhesive layer and the extension layer. The through hole is aligned with the metal conductive film layer.

[0010] A stress control membrane layer is located above the tensile membrane layer, and the stress control membrane layer includes a first interface for electrical connection with the detection circuit;

[0011] A stretching lead is inserted into the through hole, with one end of the stretching lead electrically connected to the ECG electrode and the other end electrically connected to the first interface.

[0012] A top protective film covers the stretch film layer, the stress control film layer, and the stretch lead.

[0013] Optionally, the double-sided conductive fabric layer includes a polyester substrate and a non-sensitizing metal material layer covering the surface of the polyester substrate;

[0014] The adhesive layer is distributed around the outer periphery of the metal conductive film layer, and the gaps in the areas of the conductive fabric layer that are not covered by the metal conductive film layer are filled with adhesive layer material.

[0015] Optionally, the metal conductive film layer is a double-sided conductive metal tape, and the double-sided conductive metal tape includes an adhesive conductive layer, and the adhesive conductive layer is in contact with the double-sided conductive fabric layer.

[0016] The projected area of ​​the metal conductive film layer on the bottom protective film is less than or equal to half the projected area of ​​the double-sided conductive fabric layer on the bottom protective film.

[0017] Optionally, the adhesive layer is made of silicone adhesive;

[0018] The material of the extended layer is polydimethylsiloxane, polyurethane, or platinum-catalyzed silica gel.

[0019] Optionally, the stress control film layer is a polyimide tape or a polyethylene terephthalate tape.

[0020] Optionally, the first interface in the stress control film layer includes a first interface electrode and a connection layer located on the surface of the first interface electrode.

[0021] The connecting layer is a double-sided adhesive layer that conducts electricity only in the longitudinal direction; or, the connecting layer includes a double-sided adhesive layer that conducts electricity only in the longitudinal direction and a ferromagnetic film layer located on the double-sided adhesive layer.

[0022] Optionally, the material of the stretch lead is elastic silicone material, elastic polyurethane material, or a composite material composed of elastic rubber and micron-sized metal sheets.

[0023] Optionally, the material of the top protective film is polyethylene terephthalate, polyethylene naphthalate, or polyimide.

[0024] Optionally, the detection circuit includes a second interface for electrical connection with the first interface, the second interface being a metal electrode or a magnetic conductive sheet, and the size of the second interface matching the size of the first interface.

[0025] To address the aforementioned problems, the present invention also provides a method for preparing the electrocardiogram (ECG) detection device as described above, comprising the following steps:

[0026] Forming a substrate;

[0027] The stretching layer and the adhesive layer located on the stretching layer are formed on the substrate to form the stretching film layer including the stretching layer and the adhesive layer;

[0028] The through-hole is formed continuously through the adhesive layer and the extension layer;

[0029] The electrocardiogram (ECG) electrode is formed, and the ECG electrode includes a double-sided conductive fabric layer and a metal conductive film layer located on the surface of the double-sided conductive fabric layer.

[0030] The ECG electrodes are attached to the adhesive layer, such that the metal conductive film layer in the ECG electrodes is aligned with the through hole;

[0031] Separate the substrate from the extended layer and attach the adhesive layer to the bottom protective film;

[0032] Forming the stress control film layer including the first interface;

[0033] Adhere the stress control film layer to the surface of the extension layer;

[0034] A stretch lead is formed to fill the through hole, one end of which is electrically connected to the ECG electrode and the other end is electrically connected to the first interface;

[0035] A top protective film is formed covering the stretch film layer, the stress control film layer, and the stretch lead.

[0036] The electrocardiogram (ECG) detection device and its preparation method provided by the present invention, by setting ECG electrodes including a double-sided conductive fabric layer and a metal conductive film layer located on the surface of the double-sided conductive fabric layer, and sequentially setting a stretch film layer and a stress control film layer above the ECG electrodes, and electrically connecting the ECG electrodes and a first interface located in the stress control film layer through a stretch lead penetrating the stretch film layer, thereby transmitting the detection signal of the ECG electrodes to the detection circuit through the first interface. The flexibility and stretchability of the double-sided conductive fabric layer and the stretch film layer improve the biocompatibility of the ECG detection device with the skin surface and the bonding force between the ECG electrodes and the stretch film layer, thereby improving the detection reliability and accuracy of the ECG detection device. Attached Figure Description

[0037] Appendix Figure 1 This is a schematic diagram of the electrocardiogram (ECG) detection device in a specific embodiment of the present invention;

[0038] Appendix Figure 2 This is a flowchart illustrating the preparation method of the electrocardiogram (ECG) detection device in a specific embodiment of the present invention;

[0039] Appendix Figure 3 -Appendix Figure 12 This is a schematic diagram of the main process structure in the preparation of the electrocardiogram detection device according to a specific embodiment of the present invention. Detailed Implementation

[0040] The specific embodiments of the electrocardiogram detection device and its preparation method provided by the present invention will be described in detail below with reference to the accompanying drawings.

[0041] This specific embodiment provides an electrocardiogram (ECG) detection device, with attachment Figure 1 This is a schematic diagram of the electrocardiogram (ECG) detection device in a specific embodiment of the present invention. Figure 1 As shown, the ECG detection device includes an ECG sensing patch and a detection circuit; wherein, the ECG sensing patch includes:

[0042] 10 layers of protective film at the bottom;

[0043] The electrocardiogram (ECG) electrode is located on the bottom protective film 10. The ECG electrode includes a double-sided conductive fabric layer 11 and a metal conductive film layer 12 located on the surface of the double-sided conductive fabric layer 11. The metal conductive film layer 12 is located at the center of the double-sided conductive fabric layer 11.

[0044] A stretchable film layer is located above the ECG electrode. The stretchable film layer includes an adhesive layer 13, an extension layer 14 located above the adhesive layer 13, and a through hole that continuously penetrates the adhesive layer 13 and the extension layer 14. The through hole is aligned with the metal conductive film layer 12.

[0045] A stress control membrane layer 17 is located above the stretching membrane layer, and the stress control membrane layer 17 includes a first interface 18 for electrical connection with the detection circuit.

[0046] A tension lead 16 is filled into the through hole, and one end of the tension lead 16 is electrically connected to the ECG electrode and the other end is electrically connected to the first interface 18.

[0047] The top protective film 15 covers the stretch film layer, the stress control film layer 17, and the stretch lead 16.

[0048] Specifically, the material of the bottom protective film 10 can be polyimide, polyethylene terephthalate, or polyethylene naphthalate, etc. The bottom protective film 10 serves as the carrier substrate of the ECG sensing patch and the protective film for the ECG electrodes. In some embodiments, a first separation layer is further provided on the upper surface of the bottom protective film 10 facing the stretch film layer. The first separation layer is used to separate the bottom protective film 10 from the stretch film layer, and the bottom protective film 10 from the ECG electrodes, etc., to facilitate maintenance or replacement of the stretch film layer or the ECG electrodes. The material of the first separation layer can be a fluorine-containing material.

[0049] Optionally, the double-sided conductive fabric layer 11 includes a polyester substrate and a non-allergenic metal material layer covering the surface of the polyester substrate, wherein the non-allergenic metal material includes titanium, tantalum and gold stainless steel;

[0050] The adhesive layer 13 is distributed around the outer periphery of the metal conductive film layer 12.

[0051] Optionally, the metal conductive film layer 12 is a double-sided conductive metal tape, and the double-sided conductive metal tape includes an adhesive conductive layer, and the adhesive conductive layer is in contact with the double-sided conductive fabric layer 11.

[0052] The projected area of ​​the metal conductive film layer 12 on the bottom protective film 10 is less than or equal to half of the projected area of ​​the double-sided conductive fabric layer 11 on the bottom protective film 10.

[0053] Specifically, the ECG electrode serves as the sensing electrode of the ECG sensing patch. The ECG electrode is a bilayer composite electrode composed of the double-sided conductive fabric layer 11 and the metal conductive film layer 12. The double-sided conductive fabric layer 11 is formed by depositing the non-sensitizing metal material layer on the surface of the polyester substrate. The metal conductive film layer 12 is located at the center of the surface of the double-sided conductive fabric layer 11, i.e., the axis of the metal conductive film layer 12 coincides with the axis of the double-sided conductive fabric layer 11. The size of the metal conductive film layer 12 (e.g., the width of the metal conductive film layer 12 along the direction parallel to the bottom protective film 10) does not exceed half the size of the double-sided conductive fabric layer 11 (e.g., the width of the double-sided conductive fabric layer 11 along the direction parallel to the bottom protective film 10), thereby facilitating the stable fixation of the metal conductive film layer 12 in the adhesive layer 13 through the double-sided conductive fabric layer 11. The double-sided conductive fabric layer 11 has gaps to enhance the bonding force between the ECG electrode and the adhesive layer 13, thereby improving the reliability of the electrical connection between the ECG electrode and the stretch lead 16. The conductive metal film layer 12 covers a portion of the double-sided conductive fabric layer 11. The gaps in the areas of the double-sided conductive fabric layer 11 not covered by the conductive metal film layer 12 are filled with the adhesive layer 13. On the one hand, this prevents the adhesive layer 13 from excessively filling the gaps in the double-sided conductive fabric layer 11 and overflowing onto the surface of the double-sided conductive fabric layer 11 during the integration of the ECG electrode with the adhesive layer 13, thus preventing the double-sided conductive fabric layer 11 from forming an electrical contact with the skin. On the other hand, the conductive metal film layer 12 is aligned with the through hole, allowing the conductive metal film layer 12 to cover one end of the through hole (i.e., the end of the through hole facing the bottom protective film 10). This prevents the stretching lead material from penetrating into the gaps in the double-sided conductive fabric layer 11 during the process of filling the through hole to form the stretching lead 16, further ensuring the biocompatibility of the ECG electrode with the skin contact surface. In one example, the aperture of the through hole is smaller than the width of the metal conductive film layer 12, so that the bottom opening of the through hole (i.e., the metal conductive film layer 12 covers the end of the through hole facing the bottom protective film 10) can be completely closed by the metal conductive film layer 12.

[0054] Optionally, the adhesive layer 13 is made of silicone adhesive;

[0055] The material of the extended layer 14 is polydimethylsiloxane (PDMS), polyurethane (PU), or platinum-catalyzed silica gel (Ecoflex).

[0056] Specifically, the silicone adhesive has good biocompatibility, and therefore, using the silicone adhesive to form the adhesive layer can better achieve adhesion between the ECG sensor patch and human skin.

[0057] Optionally, the stress control film layer 17 is a polyimide tape or a polyethylene terephthalate tape.

[0058] Optionally, the first interface 18 in the stress control film layer 17 includes a first interface electrode and a connection layer located on the surface of the first interface electrode.

[0059] The connecting layer is a double-sided adhesive layer that conducts electricity only in the longitudinal direction; or, the connecting layer includes a double-sided adhesive layer that conducts electricity only in the longitudinal direction and a ferromagnetic film layer located on the double-sided adhesive layer.

[0060] Optionally, the material of the stretch lead 16 is elastic silicone material, elastic polyurethane material, or a composite material composed of elastic rubber and micron-sized metal sheets.

[0061] Optionally, the material of the top protective film 15 is polyethylene terephthalate (PET), polyethylene naphthalate (PEN), or polyimide (PI).

[0062] Optionally, the detection circuit includes a second interface for electrical connection with the first interface 18, the second interface being a metal electrode or a magnetic conductive sheet, and the size of the second interface matching the size of the first interface.

[0063] Furthermore, this specific embodiment also provides a method for preparing the electrocardiogram detection device as described above, with appended details. Figure 2 This is a flowchart illustrating the preparation method of the electrocardiogram (ECG) detection device according to a specific embodiment of the present invention. Figure 3 -Appendix Figure 12 This is a schematic diagram of the main process structure in the fabrication of the electrocardiogram (ECG) detection device according to a specific embodiment of the present invention. A schematic diagram of the ECG detection device formed according to this specific embodiment can be found in [reference needed]. Figure 1 .

[0064] like Figures 1-12 As shown, the method for preparing the electrocardiogram (ECG) detection device includes the following steps:

[0065] Step S21, forming substrate 31;

[0066] Step S22: The stretching layer 14 and the adhesive layer 13 located on the stretching layer 14 are formed on the substrate 31 to form the stretching film layer including the stretching layer 14 and the adhesive layer 13.

[0067] Step S23: Form the through hole 50 that continuously penetrates the adhesive layer 13 and the extension layer 14;

[0068] Step S24, forming the ECG electrode, the ECG electrode includes a double-sided conductive fabric layer 11 and a metal conductive film layer 12 located on the surface of the double-sided conductive fabric layer 11;

[0069] Step S25: Attach the ECG electrode to the adhesive layer 13, so that the metal conductive film layer 12 in the ECG electrode is aligned with the through hole 50;

[0070] Step S26: Separate the substrate 31 from the extension layer 14 and attach the adhesive layer 13 to the bottom protective film 10;

[0071] Step S27: Form the stress control film layer 17 including the first interface 18;

[0072] Step S28: Adhere the stress control film layer 17 to the surface of the extension layer 14;

[0073] Step S29: Form the stretch lead 16 that fills the through hole 50. One end of the stretch lead 16 is electrically connected to the ECG electrode and the other end is electrically connected to the first interface 18.

[0074] Step S30: Form the top protective film 15 covering the stretch film layer, the stress control film layer 17 and the stretch lead 16.

[0075] For example, the material of the substrate 31 can be glass, polyimide, polyethylene terephthalate, polyethylene naphthalate, or parylene, etc. The substrate 31 can be ultrasonically cleaned using an ethanol solution, acetone solution, and deionized water, dried after cleaning, and then its surface treated with oxygen plasma or ultraviolet / ozone light. In one example, a second separation layer 32 is also formed on the surface of the substrate 31, such as... Figure 3 As shown. The second separation layer 32 is used for subsequent peeling of the substrate 31. The material of the second separation layer 32 can be polytetrafluoroethylene, perfluoro(1-butenyl vinyl ether) polymer, trichlorosilane, perfluorooctyl trichlorosilane, perfluorohexyl trichlorosilane, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene naphthalate, or polyimide. The second separation layer 32 can be formed by spin coating or blade coating. After forming the second separation layer 32, the extension layer 14 can be formed on the surface of the second separation layer 32 by spin coating or blade coating, such as... Figure 4As shown. In one example, the material of the extended layer 14 can be polydimethylsiloxane (PDMS), polyurethane (PU), or platinum-catalyzed silica gel (Ecoflex). Then, the adhesive layer 13 is formed on the surface of the extended layer 14, and the through-hole 50 continuously penetrating the adhesive layer 13 and the extended layer 14 is formed using a laser cutting process or a mechanical cutting process, as shown. Figure 5 As shown. In one example, the adhesive layer 13 is made of a biocompatible silicone adhesive.

[0076] After forming the double-sided conductive fabric layer 11 and the metal conductive film layer 12 respectively, the double-sided conductive fabric layer 11 and the metal conductive film layer 12 can be cut to the required size by laser cutting or mechanical cutting. Then, a bonding process is used to bond the cut double-sided conductive fabric layer 11 and the metal conductive film layer 12 together to form a shape as shown in the figure. Figure 6 The structure is shown. Then, the metal conductive film layer 12 in the ECG electrode is attached to the adhesive layer 13, with the center of the metal conductive film layer 12 aligned with the center of the through hole 50, so that the metal conductive film layer 12 can seal one end opening of the through hole 50, forming a structure as shown. Figure 7 The structure is shown. Next, the extended layer 14 is peeled off from the surface of the second separation layer 32 and transferred onto the underlying protective film 10, forming a structure as shown. Figure 8 The structure is shown. The material of the bottom protective film 10 can be polyimide, polyethylene terephthalate, or polyethylene naphthalate, etc. In some embodiments, a first separation layer is further provided on the upper surface of the bottom protective film 10 facing the stretched film layer. The material of the first separation layer can be a fluorine-containing material.

[0077] The stress control film layer 17 with the first interface 18 is attached to the surface of the extension layer 14 to form a structure as shown in the figure. Figure 9The structure shown is as follows. The first interface 18 includes a first interface electrode and a connecting layer located on the surface of the first interface electrode. The stress control film layer 17 is a polyimide (PI) tape or a polyethylene terephthalate (PET) tape, and the stress control film layer 17 is bonded to the extension layer 14. The material of the first interface electrode can be a conductive polymer, a carbon-based conductive material, a metal, a metal oxide, a metal nanowire, or a metal or metal oxide nanoparticle, etc. The first interface electrode can be formed by vacuum evaporation, magnetron sputtering, photolithography, inkjet printing, screen printing, or gravure printing. The connecting layer is a double-sided adhesive layer that conducts only longitudinally or a double-layer composite film of a double-sided adhesive layer that conducts only longitudinally and a ferromagnetic thin film. The first interface electrode can be mechanically bonded to the connecting layer. Next, the stretch lead 16, which fills the through-hole 50 and is electrically connected to the first interface 18 on the surface of the control film layer 17, can be formed by dispensing or screen printing. Figure 10 As shown. The material of the stretch lead 16 can be a composite material of elastic silicone, elastic polyurethane, or elastic rubber and micron-sized metal sheets. Then, a top protective film 15 is formed covering the extension layer 14, the stretch lead 16, the control film layer 17, and the first interface 18, as shown. Figure 11 As shown. The material of the top protective film 15 can be polyethylene terephthalate (PET), polyethylene naphthalate (PEN), or polyimide (PI).

[0078] Please refer to the connection between the ECG sensor patch and the detection circuit in this specific embodiment. Figure 12 .like Figure 12 As shown, in use, the bottom protective film 10 of the ECG sensor patch is first peeled off through the first separation layer. After the ECG sensor patch is attached to the human body surface, the top protective film 15 is peeled off. Then, the second interface 121 of the detection circuit 120 is aligned with the first interface 18 on the surface of the ECG sensor patch and pressure is applied to form an electrical connection for ECG detection. The ECG detection device also includes an ECG acquisition chip, a power supply structure, and a wireless transmission structure. The functional structure is used to supply power to the various components in the ECG detection device; the wireless transmission structure is used to transmit the signal acquired by the ECG sensor patch to the outside world. The second interface 121, which connects the detection circuit to the ECG sensor patch, is a metal electrode or a magnetic conductive sheet, and its size and position match the first interface 18 in the ECG sensor patch.

[0079] The electrocardiogram (ECG) detection device and its preparation method provided in this specific embodiment, by setting ECG electrodes including a double-sided conductive fabric layer and a metal conductive film layer located on the surface of the double-sided conductive fabric layer, and sequentially setting a stretch film layer and a stress control film layer above the ECG electrodes, and electrically connecting the ECG electrodes and a first interface located in the stress control film layer through a stretch lead penetrating the stretch film layer, thereby transmitting the detection signal of the ECG electrodes to the detection circuit through the first interface. The flexibility and stretchability of the double-sided conductive fabric layer and the stretch film layer improve the biocompatibility of the ECG detection device with the skin surface, thereby improving the detection reliability and accuracy of the ECG detection device.

[0080] The following are three embodiments of forming the ECG sensor patch.

[0081] Example 1

[0082] The ECG sensor patch is prepared through the following specific steps:

[0083] (1) Use ethanol solution, acetone solution and deionized water to ultrasonically clean the glass substrate, dry it after cleaning, and treat the substrate surface with oxygen plasma or ultraviolet light / ozone.

[0084] (2) A polyvinyl alcohol separation layer was prepared on the substrate by spin coating;

[0085] (3) A polydimethylsiloxane extension layer was prepared on the polyvinyl alcohol separation layer by a scraping process;

[0086] (4) A silicone adhesive layer is prepared on the stretchable layer using a scraping process;

[0087] (5) Through holes are formed in the extension layer and adhesive layer using laser cutting technology;

[0088] (6) An electrocardiogram electrode is formed at the through hole position using a bonding process. The electrocardiogram electrode is a composite electrode of a double-sided conductive fabric layer and a double-sided conductive copper foil tape (i.e., the metal conductive film layer).

[0089] (7) Peel off the extension layer and adhesive layer with the ECG electrodes from the surface of the polyvinyl alcohol separation layer and transfer them to the bottom protective film.

[0090] (8) A stress control film layer is bonded to the surface of the stretch layer using a bonding process;

[0091] (9) A stretching lead is formed on the surface of the stretching layer using a scraping process;

[0092] (10) A top protective film is covered on the upper surface of the extension layer, the stretch lead and the stress control film to form an electrocardiogram sensing patch.

[0093] Example 2

[0094] The ECG sensor patch is prepared through the following specific steps:

[0095] (1) Use ethanol solution, acetone solution and deionized water to ultrasonically clean the glass substrate, dry it after cleaning, and treat the substrate surface with oxygen plasma or ultraviolet light / ozone.

[0096] (2) A polytetrafluoroethylene separation layer was prepared on the substrate by spin coating;

[0097] (3) A polyplatinum catalytic silica gel (Ecoflex) extension layer was prepared on the polytetrafluoroethylene separation layer by a blade coating process;

[0098] (4) A silicone adhesive layer is prepared on the extension layer using a scraping process;

[0099] (5) Through holes are formed in the extension layer and adhesive layer using laser cutting technology;

[0100] (6) An electrocardiogram electrode is formed at the through hole position using a bonding process. The electrocardiogram electrode is a composite electrode of a double-sided conductive fabric layer and a double-sided conductive copper foil tape (i.e., the metal conductive film layer).

[0101] (7) Peel off the extended layer and adhesive layer with ECG electrodes from the surface of the polytetrafluoroethylene separation layer and transfer them to the bottom protective film.

[0102] (8) A stress control film layer is bonded to the surface of the stretch layer using a bonding process;

[0103] (9) A stretching lead is formed on the surface of the stretching layer using a scraping process;

[0104] (10) A top protective film is covered on the upper surface of the extension layer, the stretch lead and the stress control film to form an electrocardiogram sensing patch.

[0105] Example 3

[0106] The ECG sensor patch is prepared through the following specific steps:

[0107] (1) Use ethanol solution, acetone solution and deionized water to ultrasonically clean the glass substrate, dry it after cleaning, and treat the substrate surface with oxygen plasma or ultraviolet light / ozone.

[0108] (2) A polyimide separation layer was prepared on the substrate by a blade coating method;

[0109] (3) A polyplatinum catalytic silica gel (Ecoflex) extension layer was prepared on the polyimide separation layer using a blade coating process;

[0110] (4) A silicone adhesive layer is prepared on the extension layer using a scraping process;

[0111] (5) Through holes are formed in the extension layer and adhesive layer using laser cutting technology;

[0112] (6) An electrocardiogram electrode is formed at the through hole position using a bonding process. The electrocardiogram electrode is a composite electrode of a double-sided conductive fabric layer and a double-sided conductive copper foil tape (i.e., the metal conductive film layer).

[0113] (7) Peel off the extended layer and adhesive layer with ECG electrodes from the surface of the polyimide separation layer and transfer them to the bottom protective film.

[0114] (8) A stress control film layer is bonded to the surface of the stretch layer using a bonding process;

[0115] (9) A stretching lead is formed on the surface of the stretching layer using a scraping process;

[0116] (10) A top protective film is covered on the upper surface of the extension layer, the stretch lead and the stress control film to form an electrocardiogram sensing patch.

[0117] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. An electrocardiogram detection device, characterized by, It includes an ECG sensor patch and a detection circuit; wherein, the ECG sensor patch includes: Underlying protective film; The electrocardiogram (ECG) electrode is located on the bottom protective film. The ECG electrode includes a double-sided conductive fabric layer and a metal conductive film layer located on the surface of the double-sided conductive fabric layer. The metal conductive film layer is located at the center of the double-sided conductive fabric layer. A stretchable film layer is located above the ECG electrode. The stretchable film layer includes an adhesive layer, an extension layer located above the adhesive layer, and a through hole that continuously penetrates the adhesive layer and the extension layer. The through hole is aligned with the metal conductive film layer. A stress control membrane layer is located above the tensile membrane layer, and the stress control membrane layer includes a first interface for electrical connection with the detection circuit; A stretching lead is inserted into the through hole, with one end of the stretching lead electrically connected to the ECG electrode and the other end electrically connected to the first interface. A top protective film covers the stretch film layer, the stress control film layer, and the stretch lead wire; The double-sided conductive fabric layer includes a polyester substrate and a non-sensitizing metal material layer covering the surface of the polyester substrate; the adhesive layer is distributed around the outer periphery of the metal conductive film layer, and the gaps in the areas of the double-sided conductive fabric layer not covered by the metal conductive film layer are filled with adhesive layer material. The conductive metal film layer is a double-sided conductive metal tape, and the double-sided conductive metal tape includes an adhesive conductive layer, and the adhesive conductive layer is in contact with the double-sided conductive fabric layer. The projected area of ​​the metal conductive film layer on the bottom protective film is less than or equal to half of the projected area of ​​the double-sided conductive fabric layer on the bottom protective film. The first interface in the stress control film layer includes a first interface electrode and a connection layer located on the surface of the first interface electrode. The connecting layer is a double-sided adhesive layer that conducts electricity only in the longitudinal direction; or, the connecting layer includes a double-sided adhesive layer that conducts electricity only in the longitudinal direction and a ferromagnetic film layer located on the double-sided adhesive layer. The material of the stretching lead is elastic silicone, elastic polyurethane, or a composite material of elastic rubber and micron-sized metal sheets.

2. The electrocardio detection device according to claim 1, wherein The adhesive layer is made of silicone adhesive; The material of the extended layer is polydimethylsiloxane, polyurethane, or platinum-catalyzed silica gel.

3. The electrocardio detection device according to claim 1, wherein The stress control film is a polyimide tape or a polyethylene terephthalate tape.

4. The electrocardio detection device according to claim 1, wherein The material of the top protective film is polyethylene terephthalate, polyethylene naphthalate, or polyimide.

5. The electrocardio detection device according to claim 1, wherein The detection circuit includes a second interface for electrical connection with the first interface. The second interface is a metal electrode or a magnetic conductive sheet, and the size of the second interface matches the size of the first interface.

6. A method of manufacturing an electrocardio detection device according to claim 1, wherein Includes the following steps: Forming a substrate; The stretching layer and the adhesive layer located on the stretching layer are formed on the substrate to form the stretching film layer including the stretching layer and the adhesive layer; The through-hole is formed continuously through the adhesive layer and the extension layer; The electrocardiogram (ECG) electrode is formed, and the ECG electrode includes a double-sided conductive fabric layer and a metal conductive film layer located on the surface of the double-sided conductive fabric layer. The ECG electrodes are attached to the adhesive layer, such that the metal conductive film layer in the ECG electrodes is aligned with the through hole; Separate the substrate from the extended layer and attach the adhesive layer to the bottom protective film; Forming the stress control film layer including the first interface; Adhere the stress control film layer to the surface of the extension layer; A stretch lead is formed to fill the through hole, one end of which is electrically connected to the ECG electrode and the other end is electrically connected to the first interface; A top protective film is formed covering the stretch film layer, the stress control film layer, and the stretch lead.

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