CN110840448B - Electrocardiogram electrode patch and preparation method thereof - Google Patents
Electrocardiogram electrode patch and preparation method thereof Download PDFInfo
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- CN110840448B CN110840448B CN201911308735.XA CN201911308735A CN110840448B CN 110840448 B CN110840448 B CN 110840448B CN 201911308735 A CN201911308735 A CN 201911308735A CN 110840448 B CN110840448 B CN 110840448B
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- 238000002360 preparation method Methods 0.000 title claims description 11
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- 229920006267 polyester film Polymers 0.000 claims description 12
- 229910052709 silver Inorganic materials 0.000 claims description 11
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- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 4
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- 229910052751 metal Inorganic materials 0.000 description 2
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- 229920002799 BoPET Polymers 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
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Abstract
The patch comprises an insulating film, a plurality of lead wires printed on the inner surface of the film, a plurality of contact electrodes printed on the outer surface of the film and an anti-interference film attached to the inner surface, wherein the insulating film is provided with a via hole, a contact area of the insulating film is integrally connected between a first side lead-out area and a second side lead-out area, the inner electrodes of the lead wires are positioned in the contact area, the lead-out electrodes of the lead wires are dispersed in the first side lead-out area and the second side lead-out area, the distance between the lead-out electrodes is larger than that between the inner electrodes, the contact electrodes are intensively positioned in the contact area and electrically connected with the corresponding inner electrodes through the via hole, and a signal shielding structure is arranged on the anti-interference film to cover a line section of the lead wires. The invention has the effects of multiple anti-interference and size miniaturization.
Description
Technical Field
The invention relates to the technical field of consumables used by electrocardio sensor equipment, in particular to an electrocardio electrode patch and a preparation method thereof.
Background
The electrocardio sensor equipment is used for collecting human electrocardio signals, the corresponding medical electrocardio electrode patch is a disposable consumable product attached to a human body, the electrocardio sensor equipment needs to accurately collect human heart bioelectric energy signals, and the electrocardio electrode patches in the current market are mainly imported. However, the electrocardiograph electrode patch commonly adopted in the market at present uses single-layer PET or PI as a base material, conductive paste and silver chloride paste are only printed on a single surface based on cost consideration, and are respectively used as a lead wire and a contact electrode of the patch, so that the electrocardiograph electrode patch is easy to be interfered by external signals when being used in a responsible environment of simultaneous operation of multiple clinical monitoring devices, and human electrocardiograph signals received by an electrocardiograph sensor are distorted, and therefore, how to resist the signal interference is a problem which needs to be overcome in the market of the medical electrocardiograph sensor generally. If the size of the electrocardio electrode patch is simply increased, the manufacturing cost is increased, and when the posture of a human body is changed in use, the traditional electrocardio electrode patch is easy to loose or fall off from the position of the electrocardio electrode patch of the human body, so that the electrocardio signal of the human body cannot be sensed. In addition, the lead wires of the electrocardio electrode patch are all terminal connectors for pulling signals to the same side of the patch so as to be combined with the plug-in type connector, signal interference exists at the terminal connector too close to the terminal connector, and the cost of the connector serving as a consumable and the lead wires is increased.
Chinese patent application publication No. CN109009081a discloses an integrated electrocardiogram electrode patch, which comprises a connector and an electrode patch body. The electrode patch body comprises a flexible circuit board and conductive adhesive. The flexible circuit board is provided with a plurality of electrodes for measuring electrocardiogram signals; and conductive adhesive formed on the surfaces of the electrodes. The integrated electrocardiogram electrode patch can be attached to the surface of a human body in a volt-form. The flexible circuit board is provided with a plurality of conductive circuits on the same side as the electrodes.
Chinese patent application publication No. CN109846475a discloses a disposable electrocardio monitoring electrode and wire, including the electrode slice, the one end of electrode slice is connected with affiliated wire, the one end surface that affiliated wire kept away from the electrode slice is provided with the grafting end, the surface of grafting end is provided with two metal poles, the one end that affiliated wire kept away from the electrode slice is provided with the adaptation connecting wire, the one end that the adaptation connecting wire is close to the grafting end is provided with the slot, the inside of slot is provided with the grafting pipe with metal pole grafting complex, the electrode slice includes the backup pad, the top of backup pad is provided with the tie layer, the bottom of backup pad is provided with the current-conducting plate, the bottom of current-conducting plate is provided with the adhesion layer, the bottom of electrode slice is provided with the protective layer.
Disclosure of Invention
The invention provides an electrocardio electrode patch which is used for solving the problem that the electrocardio electrode patch is easy to be interfered by external signals and realizing the functions of miniaturization and multiple anti-interference of the size of a disposable electrocardio electrode patch.
The invention provides a preparation method of an electrocardio electrode patch, which is used for realizing efficient manufacturing of the small-size anti-interference electrocardio electrode patch with multiple anti-interference functions.
The main purpose of the invention is realized by the following technical scheme:
an electrocardio electrode patch is proposed, comprising:
the insulation film is provided with an outer surface, an inner surface and a plurality of penetrating through holes, the insulation film is divided into a contact area, a first side lead-out area and a second side lead-out area according to the shape area, the through holes are formed in the contact area, and the contact area is integrally connected between the first side lead-out area and the second side lead-out area;
a plurality of lead wires printed on the inner surface of the insulating film, one end of the lead wires being integrally formed as an inner electrode, the other end of the lead wires being integrally formed as an outer electrode, the inner electrodes being located in the contact region, each inner electrode covering one or more of the via holes, the outer electrodes being dispersed at the first side outer region and the second side outer region such that a pitch of the outer electrodes is greater than that of the inner electrodes;
a plurality of contact electrodes printed on the outer surface of the insulating film, the contact electrodes being concentrated in the contact region and corresponding to the inner electrodes, each contact electrode covering one or more of the vias through which the corresponding inner electrode is electrically connected, and
the anti-interference film is attached to the inner surface of the insulating film, and a signal shielding structure is arranged on the anti-interference film and covers the line section of the lead line.
According to the technical scheme I, the lead wire and the contact electrode are respectively formed on the inner surface and the outer surface of the insulating film and conducted through the through hole, the anti-interference film is attached to the inner surface of the insulating film and the scattered arrangement of the lead electrodes, when the anti-interference device is used, the insulating film isolates interference of human bioelectricity on the lead wire, the thickness of the insulating film ensures the minimum isolation distance between the lead wire and the contact human body under random bending of the electrocardio electrode patch, the signal shielding structure arranged on the anti-interference film covers the wire section of the lead wire, the interference of external signals running simultaneously by multiple monitoring devices on the wire section of the lead wire is isolated, the distance between the lead electrodes is larger than that between the internal electrodes, the interference between the external signals on the lead electrodes is isolated, the multiple anti-interference effect is achieved, a plug terminal positioned on the same side and an extension wire of the lead connecting plug terminal are not needed, and the size of the patch of the disposable electrocardio electrode patch can be realized. In a specific application, the electrocardio electrode patch can be even arranged on the joint surface of the electrocardio sensor after the size is reduced, and the electrocardio sensing position is adjusted in a mode that hands of an operator are not required to directly contact with the electrocardio electrode patch.
The present invention may be further configured in a preferred example to: the patch further comprises a limit coating layer which is printed on the inner surface of the insulating film and is isolated between the line sections of the adjacent lead wires, or when the second side leading-out area is a plurality of and is led out by the contact area in series, the gap between the contact area and the section nearest to the second side leading-out area, adjacent to the line sections of the lead wires, is larger than the thickness of the insulating film, and preferably, the gap between the contact area and the section nearest to the second side leading-out area is larger than or equal to 0.015mm.
According to the preferable technical scheme, the spacing coating is utilized to be isolated between the line sections of the adjacent lead wires, the function of limiting the lower limit value of the gap between the line sections of the adjacent lead wires can be exerted in the use occasion of bending the electrocardio electrode patch, and particularly, the gap can be limited to be more than or equal to 0.015mm so as to avoid mutual signal interference between the line sections of the adjacent lead wires excessively close to the leading-out line sections when bending the electrocardio electrode patch, or the gap between the contact area and the section closest to the leading-out area on the second side is utilized to be larger than the thickness of the insulating film, so that the degree of mutual signal interference between the line sections of the adjacent lead wires can be reduced or/and the gap filling of the spacing coating is facilitated.
The present invention may be further configured in a preferred example to: the patch also comprises an insulating ink layer which is printed on the inner surface of the anti-interference film, and the printing thickness of the insulating ink layer is preferably 15-25 mu m.
By adopting the preferable technical scheme, the signal shielding structure and the lead wire are electrically isolated by utilizing the formation of the insulating ink layer, so that the signal wire and the signal shielding structure are prevented from being electrically short-circuited.
The present invention may be further configured in a preferred example to: the contact electrode includes a lead pad layer on the outer surface of the insulating film and a contact layer on the lead pad layer; preferably, the inner electrode is not covered by the anti-interference film, or the anti-interference film covers the inner electrode.
By adopting the preferable technical scheme, the multi-layer structure of the contact electrode and the lead cushion layer positioned at the bottom are utilized to realize the through hole conduction between the contact electrode and the lead wire, and the contact layer of the contact electrode is prevented from being diffused and polluted to the inner surface of the insulating film; the first preferred mode is that the anti-interference film does not cover the inner electrode, so that the contact electrode has better flexibility to be closely attached to a human body electrocardio sensing point; or, the second preferred, the anti-interference film covers the inner electrode, so that the inner electrode has better positioning and shielding effects on the inner surface, and the sliding or loosening of the inner electrode is avoided.
The present invention may be further configured in a preferred example to: the signal shielding structure is printed on the inner surface of the anti-interference film.
By adopting the above preferred technical scheme, the signal shielding structure is formed on the inner surface of the film of the anti-interference film by printing, so that the signal shielding structure is closer to the line section of the lead line, a better anti-interference effect is achieved, and the outer surface of the film of the anti-interference film can provide an exposed surface of a flat printable identification pattern.
The present invention may be further configured in a preferred example to: the outline shape of the signal shielding structure corresponds to the line section of the lead wire, and the width of the signal shielding structure is larger than the width of the line section of the lead wire; preferably, the signal shielding structure comprises shielding lines, shielding points or a combination thereof.
By adopting the preferable technical scheme, the specific contour outline and width limitation of the signal shielding structure are utilized to accurately shield the line section of the lead line.
The present invention may be further configured in a preferred example to: the via hole comprises a central hole and a plurality of peripheral holes surrounding the central hole, wherein the distance from the peripheral holes to the central hole is smaller than the radius of the inner electrode, specifically, the diameter of the via hole is 0.015-0.15 mm, and preferably, the diameter of the via hole is 0.015-0.05 mm.
By adopting the preferable technical scheme, the inner electrode can substantially and completely cover the via hole by limiting the hole configuration of the via hole and the distance from the peripheral hole to the central hole, the peripheral hole can be used as a buffer hole of the central hole, the electric connection of the central hole is not affected even if the electric connection of the peripheral hole breaks, and the through hole conduction of the contact electrode and the inner electrode can be realized by specifically utilizing the specific diameter size range of the via hole, and the printing coating can not excessively diffuse and overflow on the other surface of the film.
The present invention may be further configured in a preferred example to: the thickness of the polyester film of the insulating film is 0.025-0.1 mm, the thickness of the silver paste coating of the lead wire is 4-12 mu m, and the line width of the line section of the lead wire is 0.2-1.2 mm.
By adopting the above preferred technical scheme, the electrocardio electrode patch has a sufficiently miniaturized line section and sufficiently thinned layers of thicknesses for being combined with the joint surface of the electrocardio sensor by utilizing the specific polyester film thickness range, the silver paste brushing thickness range and the line width range of the line section of the lead line.
The main purpose of the invention is realized by the following technical scheme:
the preparation method of the electrocardio electrode patch comprises the following steps:
providing an insulating film, wherein the insulating film is provided with an outer surface, an inner surface and a plurality of penetrating through holes, the insulating film is divided into a contact area, a first side lead-out area and a second side lead-out area, the through holes are formed in the contact area, and the contact area is integrally connected between the first side lead-out area and the second side lead-out area;
forming a plurality of lead wires on the inner surface of the insulating film by first printing, wherein one end of each lead wire is formed into an inner electrode, the other end of each lead wire is formed into an extraction electrode, the inner electrodes are positioned in the contact area, each inner electrode covers one or more through holes, and the extraction electrodes are scattered in the first side extraction area and the second side extraction area, so that the interval between the extraction electrodes is larger than that between the inner electrodes;
forming a plurality of contact electrodes on the outer surface of the insulating film by a second printing, wherein the contact electrodes are positioned in the contact areas and correspond to the inner electrodes, each contact electrode covers one or more through holes, and the corresponding inner electrodes are electrically connected through the through holes, and
and an anti-interference film is attached to the inner surface of the insulating film, and a signal shielding structure is arranged on the inner surface of the anti-interference film and covers the line section of the lead line.
Through adopting the basic technical scheme II, the lead wire and the contact electrode are respectively formed by double-sided twice printing and are conducted through the through hole of the insulating film, the anti-interference film is attached, the lead wire is clamped between the insulating film and the anti-interference film, the insulating film isolates the interference of human bioelectricity to the lead wire, and the signal shielding structure of the anti-interference film isolates the interference of an external signal to the line section of the lead wire, so that the electrocardio electrode patch with multiple anti-interference effects is obtained.
The present invention may be further configured in a preferred example to: the via hole comprises a central hole and a plurality of peripheral holes surrounding the central hole, wherein the distance from the peripheral holes to the central hole is smaller than the radius of the inner electrode, specifically, the diameter of the via hole is 0.015-0.15 mm, preferably 0.015-0.05-mm, the polyester film thickness of the insulating film is 0.025-0.1-mm, the silver paste coating thickness of the lead wire is 4-12 mu m, and the line width of the line section of the lead wire is 0.2-1.2-mm.
In summary, the present invention includes at least one of the following beneficial technical effects:
1. the size miniaturization and multiple anti-interference functions of the disposable electrocardio electrode patch are realized, and the product is designed in a full-thin film manner, so that a plug terminal or/and an external lead wire positioned on the same side is not needed; specifically, the anti-interference effect of the electrocardio electrode patch can be effectively achieved by the three-prevention design, namely the anti-interference effect of the electrocardio electrode patch, the anti-interference effect of the electrocardio electrode patch on a human body to be attached and the anti-interference effect of the electrocardio electrode patch on external environment equipment are achieved;
2. the disposable electrocardio electrode patch can be loaded on the sensing head of the electrocardio sensor in a miniaturized and thinned form;
3. the preparation process of the electrocardio electrode patch needs to use printing equipment and laminating equipment, does not need mounting equipment for combining device endpoints except film surface treatment equipment, has relatively simple treatment process and can manufacture the electrocardio electrode patch with multiple anti-interference functions.
Drawings
FIG. 1 is a schematic view of explosion of each membrane layer and a partial enlarged view of a signal shielding structure of an ECG electrode patch according to a first embodiment of the present invention;
FIG. 2 is a schematic diagram showing an electrocardiograph electrode patch according to a first preferred embodiment of the present invention;
FIG. 3A is a schematic view of a partial cross-section at an inner electrode according to a first preferred embodiment of the invention;
FIG. 3B is a schematic view showing a partial top surface at the inner electrode according to the first preferred embodiment of the invention;
FIG. 4 is a flowchart showing a process for manufacturing an ECG electrode patch according to a second preferred embodiment of the present invention;
fig. 5A to 5D are schematic views of a thin film contact region in a partial cross-section in each main step in the process of manufacturing an electrocardiographic electrode patch according to a second preferred embodiment of the present invention;
FIG. 6 is an exploded view of the membrane layers of an ECG electrode patch according to a third preferred embodiment of the present invention;
fig. 7 is a schematic perspective view of an electrocardiograph electrode patch according to a third preferred embodiment of the present invention.
Reference numerals are 10, an insulating film, 11, a contact area, 12, a first side lead-out area, 13, a nearest second side lead-out area, 14, a relatively far second side lead-out area, 20, a lead wire, 21, an inner electrode, 22, a lead electrode, 30, a contact electrode, 31, a lead cushion layer, 32, a contact layer, 40, an anti-interference film, 41, a signal shielding structure, 42, an insulating film, 50, a via hole, 51, a central hole, 52, a peripheral hole, 60, a limiting coating layer, 70 and an insulating ink layer.
Detailed Description
The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is apparent that the described embodiments are only examples for understanding a part of the inventive concept of the present invention, and are not representative of all embodiments, nor are they to be construed as the only embodiments. All other embodiments, based on the embodiments of the present invention, which are obtained by those of ordinary skill in the art under the understanding of the inventive concept of the present invention, are within the scope of the present invention.
It should be noted that, if directional indications (such as up, down, left, right, front, and rear … …) are included in the embodiments of the present invention, the directional indications are merely used to explain the relative positional relationship, movement conditions, etc. between the components in a specific posture (as shown in the drawings), and if the specific posture is changed, the directional indications are correspondingly changed.
In order to facilitate understanding of the technical scheme of the present invention, the electrocardiograph electrode patch and the preparation method thereof of the present invention are described and explained in further detail below, but are not intended to limit the scope of protection of the present invention.
The electrocardiograph electrode patch and the preparation method thereof according to the present invention are described in further detail below, but should not limit the scope of protection of the present invention.
FIG. 1 is a schematic view of explosion of each membrane layer of an electrocardio electrode patch and a partial enlarged view of a signal shielding structure, FIG. 2 is a schematic view of an electrocardio electrode patch in perspective, and FIG. 3A is a schematic view of an internal electrode in partial cross section; FIG. 3B is a schematic view of a portion of the upper surface at the inner electrode; referring to fig. 1 and 2, a first embodiment of the present invention discloses an electrocardiographic electrode patch including an insulating film 10, a plurality of lead wires 20, a plurality of contact electrodes 30, and an anti-interference film 40.
The insulation film 10 has an outer surface, an inner surface and a plurality of through holes 50, the insulation film 10 is divided into a contact area 11, a first side lead-out area 12 and second side lead-out areas 13 and 14 according to the shape, the through holes 50 are arranged in the contact area 11, the contact area 11 is integrally connected between the first side lead-out area 12 and the second side lead-out areas 13 and 14, the insulation film 10 can be a PET polyester film, the color of the insulation film can be transparent, white or black, more particularly a transparent insulation film, and the insulation film is used for observing whether the position of the lead wire 20 is printed well. In this embodiment, the second side lead-out regions 13,14 are plural, and one of the second side lead-out regions 14 is farther from the contact region 11 than the other second side lead-out region 13.
The lead wires 20 are printed on the inner surface of the insulating film 10, one ends of the lead wires 20 are integrally formed into inner electrodes 21, the other ends of the lead wires 20 are integrally formed into lead-out electrodes 22, the inner electrodes 21 are positioned in the contact areas 11, each inner electrode 21 is covered with one or more through holes 50, the lead-out electrodes 22 are dispersed in the first side lead-out areas 12 and the second side lead-out areas 13 and 14 in a manner that the distance between the lead-out electrodes 22 is larger than that between the inner electrodes 21, the lead wires 20 are specifically printed conductive wires, such as silver paste, carbon paste, biological carbon paste, nano silver paste, graphene, carbon nano tubes and other conductive pastes, are printed and cured to form the conductive wires, more specifically silver paste printed conductive wires, and have excellent conductivity and flexibility and fracture resistance. In the present embodiment, the wire section of the lead wire 20 to which the lead-out electrode 22 of one of the second side lead-out regions 14 located relatively far away is correspondingly connected is arc-shaped in winding shape while passing through the nearest second side lead-out region 13, and the lead-out electrode 22 of the nearest second side lead-out region 13 is kept at the same gap to avoid signal interference between the wire section and the lead-out electrode.
Referring to fig. 3A, the contact electrodes 30 are printed on the outer surface of the insulating film 10, the contact electrodes 30 are centrally located in the contact region 11 and correspond to the inner electrodes 21, each contact electrode 30 covers one or more of the vias 50, and the corresponding inner electrode 21 is electrically connected through the via 50. The contact electrode 30 is used for contacting the surface of the human body at the cardiac sensing point. In addition, the anti-interference film 40 is attached to the inner surface of the insulating film 10, and a signal shielding structure 41 is disposed on the anti-interference film 40 to cover the wire section of the lead wire 20.
The implementation principle of the embodiment is as follows: the lead wire 20 and the contact electrode 30 are respectively formed on the inner surface and the outer surface of the insulating film 10 and conducted through the via hole 50, the anti-interference film 40 is attached to the inner surface of the insulating film 10, and the lead electrode 22 are arranged in a dispersed manner, so that the insulating film 10 isolates the interference of human bioelectricity on the lead wire 20 when in use, and the thickness of the insulating film 10 ensures the minimum isolation distance between the lead wire 20 and the contact human body under any bending of the electrocardio electrode patch when in use; the signal shielding structure 41 provided on the anti-interference film 40 covers the line section of the lead wire 20, isolates the interference of external signals running simultaneously by multiple monitoring devices on the line section of the lead wire 20, the distance between the extraction electrodes 22 is larger than that between the internal electrodes 21, isolates the interference of external signals between the extraction electrodes 22, thereby obtaining multiple anti-interference effects, eliminating the need of plug terminals on the same side and extension wires for pulling and connecting the plug terminals, and realizing the miniaturization of the disposable electrocardio electrode patch. In a specific application, the electrocardio electrode patch can be even arranged on the joint surface of the electrocardio sensor after the size is reduced, and the electrocardio sensing position is adjusted in a mode that hands of an operator do not need to directly contact with the electrocardio electrode patch.
With respect to a specific structure of the lead wires 20, each lead wire 20 has a middle wire section, one end of which is connected to one inner electrode 21 and the other end of which is connected to one lead electrode 22. The arrangement direction of the plurality of internal electrodes 21 is preferably perpendicular to the arrangement direction of the plurality of lead-out electrodes 22, so that the correspondingly connected contact electrodes 30 can be densely arranged, and therefore the length occupied by the contact area 11 relative to the whole length of the electrocardio electrode patch can be effectively reduced, which is beneficial to the contact of the electrocardio sensor and the dispersion of the lead-out electrodes 22 by the line section of the lead wire 20.
Regarding one possible structure for increasing the restriction of the lead wire 20, in a preferred example, the electrocardio electrode patch further comprises a restriction coating 60 printed on the inner surface of the insulating film 10, the restriction coating 60 being isolated between the line sections adjacent to the lead wire 20, or when the second side lead-out regions 13,14 are plural and are serially led out from the contact region 11, a gap between the contact region 11 and a line section adjacent to the lead wire 20 at a section nearest to the second side lead-out regions 13,14 is larger than a thickness of the insulating film 10, preferably, a gap between the line sections adjacent to the lead wire 20 is equal to or larger than 0.015mm. Therefore, the spacing coating 60 is used to isolate the wire sections adjacent to the lead wires 20, so that the function of limiting the lower limit value of the gap between the wire sections adjacent to the lead wires 20 can be exerted in the use occasion of bending the electrocardio electrode patch, and particularly, the gap can be limited to be more than or equal to 0.015mm so as to avoid mutual signal interference between the wire sections adjacent to the lead wires 20 when bending the electrocardio electrode patch, or the gap between the contact area 11 and the section nearest to the second side lead-out area 13 is used to be larger than the thickness of the insulating film 10, so that the degree of mutual signal interference between the wire sections adjacent to the lead wires 20 can be reduced or/and the gap filling of the spacing coating 60 is facilitated. In this embodiment, the limiting coating 60 has an opening exposing the extraction electrode 22.
Regarding an implementation of the surface insulation coating of the signal shielding structure 41, in a preferred example, the electrocardio electrode patch further includes an insulation ink layer 70 printed on the inner surface of the anti-interference film 40, and preferably, the printing thickness of the insulation ink layer 70 is 15-25 μm. Therefore, by forming the insulating ink layer 70, the signal shielding structure 41 and the lead wire 20 are electrically isolated, and electrical short circuit between the signal wire and the signal shielding structure 41 is avoided.
Regarding one possible position of the signal shielding structure 41, in a preferred example, the signal shielding structure 41 is printed on the inner face of an insulating film 42 such as a PET film in the anti-interference film 40. Therefore, the signal shielding structure 41 is formed on the inner surface of the anti-interference film 40 by printing, so that the signal shielding structure 41 is closer to the line section of the lead line 20, a better anti-interference effect is achieved, and an exposed surface of the flat printable identification pattern can be provided on the outer surface of the insulating film 42 of the anti-interference film 40. The insulating film 42 may be transparent, white or black in color, more specifically, a white insulating film, and a logo pattern or other graphics may be printed on the outer surface of the insulating film 42.
Regarding one possible aspect of the signal shielding structure 41, in a preferred example, the contour outline of the signal shielding structure 41 corresponds to the line section of the lead line 20 and the width of the signal shielding structure 41 is larger than the line section of the lead line 20; preferably, the signal shielding structure 41 comprises shielding lines, shielding points or a combination thereof. Therefore, the specific contour profile and width of the signal shielding structure 41 are utilized to precisely shield the line segment of the lead line 20.
With respect to one embodiment of the contact electrode 30, in a preferred example, referring to fig. 3A, the contact electrode 30 includes a lead pad layer 31 and a contact layer 32, the lead pad layer 31 is located on the outer surface of the insulating film 10, and the contact layer 32 is located on the lead pad layer 31. Therefore, with the multilayer structure of the contact electrode 30 and the lead pad layer 31 at the bottom, the through-hole conduction between the contact electrode 30 and the lead wire 20 is achieved, and diffusion contamination of the contact layer 32 of the contact electrode 30 to the inner surface of the insulating film 10 is prevented. Preferably, the anti-interference film 40 does not cover the inner electrode 21, so that the contact electrode 30 has better flexibility to be closely attached to the cardiac sensing point of the human body. In this embodiment, the lead pad layer 31 is a conductive pattern formed by silver paste printing, and the contact layer 32 is a conductive pattern formed by silver chloride paste printing, and the patterns may be identical.
Regarding one possible configuration and size range of the via hole 50, in a preferred example, referring to fig. 3A and 3B, the via hole 50 includes a central hole 51 and a plurality of peripheral holes 52 surrounding the central hole 51, and a distance from the peripheral holes 52 to the central hole 51 is smaller than a radius of the inner electrode 21, specifically, a diameter of the via hole 50 is 0.015-0.15 mm, preferably 0.015-0.05 mm. Therefore, the via hole 50 is defined by the hole arrangement and the distance from the peripheral hole 52 to the central hole 51, so that the internal electrode 21 can substantially and completely cover the via hole 50, the peripheral hole 52 can be used as a buffer hole for the central hole 51, the electrical connection of the central hole 51 is not affected even if the electrical connection of the peripheral hole 52 breaks, and the contact electrode 30 and the through hole of the internal electrode 21 can be conducted by the specific diameter size range of the via hole 50 without excessively diffusing and overflowing on the other surface of the film.
With respect to one practical size range of each main member, in a preferred example, the polyester film thickness of the insulation film 10 is 0.025 to 0.1. 0.1 mm, the silver paste coating thickness of the lead wire 20 is 4 to 12 μm, and the wire width of the wire section of the lead wire 20 is 0.2 to 1.2 mm. Therefore, the electrocardio electrode patch has a sufficiently miniaturized line section and sufficiently thinned layers of thickness for bonding to the bonding face of the electrocardio sensor by utilizing a specific polyester film thickness range, a silver paste brushing thickness range and a line width range of the line section of the lead line 20.
Regarding an overall shape and size of the electrocardio electrode patch, basically in this embodiment, the shape of the electrocardio electrode patch may be a strip shape with a width variation, the part of the line section of the lead wire 20 is narrowest, the first side lead-out area 12 and the second side lead-out areas 13 and 14 are the second widest, the contact area 11 is the widest, the positions of the areas are quickly confirmed by the width variation in use, and in addition, the overall length of the electrocardio electrode patch may be controlled to be 10-18 cm, and the total film thickness may be controlled to be 0.06-0.3 mm.
In addition, the second embodiment of the present invention further provides a method for manufacturing an electrocardiograph electrode patch of the first embodiment or an electrocardiograph electrode patch with a similar function, and fig. 4 is a flowchart of the manufacturing process; FIGS. 5A-5D are schematic views of a thin film contact region 11 in a partially cross-sectional view at main steps in the manufacturing process; the preparation method comprises the following main steps S1 to S4.
Referring to fig. 5A, the insulating film 10 is divided into a contact region 11, a first side lead-out region 12 and second side lead-out regions 13 and 14 by the insulating film 10, wherein the via 50 is arranged in the contact region 11, and the contact region 11 is integrally connected between the first side lead-out region 12 and the second side lead-out regions 13 and 14;
referring to fig. 5B, a plurality of lead wires 20 are first printed on the inner surface of the insulating film 10, one end of the lead wires 20 is formed into an inner electrode 21, the other end of the lead wires 20 is formed into an outer electrode 22, the inner electrode 21 is positioned in the contact region 11, each inner electrode 21 covers one or more of the through holes 50, and the outer electrodes 22 are dispersed in the first side outer region 12 and the second side outer regions 13,14, so that the distance between the outer electrodes 22 is larger than that between the inner electrodes 21;
referring to fig. 5C, a plurality of contact electrodes 30 are formed on the outer surface of the insulating film 10 by a second printing process, wherein the contact electrodes 30 are located in the contact areas 11 and correspond to the inner electrodes 21, each contact electrode 30 covers one or more of the vias 50, and the corresponding inner electrode 21 is electrically connected through the via 50;
in step S4, an anti-interference film 40 is attached to the inner surface of the film, referring to fig. 5D, an anti-interference film 40 is attached to the inner surface of the insulating film 10, and a signal shielding structure 41 is disposed on the inner surface of the anti-interference film 40 to cover the line section of the lead line 20.
Specifically, the main steps S1 to S4 are all implemented on a film master, a plurality of unit areas corresponding to the film shape of the product are integrated together, and the required monomer shape is cut after the printing and attaching process is completed.
The implementation principle of the embodiment is as follows: the conductive wire 20 and the contact electrode 30 are respectively formed by double-sided twice printing, the via hole 50 of the insulating film 10 is conducted, the anti-interference film 40 is attached, the conductive wire 20 is clamped between the insulating film 10 and the anti-interference film 40, the insulating film 10 isolates the interference of human bioelectricity to the conductive wire 20, the signal shielding structure 41 of the anti-interference film 40 isolates the interference of external signals to the wire section of the conductive wire 20, and thus the electrocardio electrode patch with multiple anti-interference effects is obtained.
Regarding a possible size range of the via hole 50 and other main members, in a preferred example, the via hole 50 includes a central hole 51 and a plurality of peripheral holes 52 surrounding the central hole 51 corresponding to each of the inner electrodes 21, a distance from the peripheral holes 52 to the central hole 51 is smaller than a radius of the inner electrodes 21, specifically, a diameter of the via hole 50 is 0.015 to 0.15mm, preferably 0.015 to 0.05 mm, a polyester film thickness of the insulating film 10 is 0.025 to 0.1 mm, a silver paste coating thickness of the lead wire 20 is 4 to 12 μm, and a line width of a line section of the lead wire 20 is 0.2 to 1.2 mm.
FIG. 6 is a schematic view of explosion of the membrane layers of another electrocardio electrode patch, and FIG. 7 is a partial cross-sectional view of the electrocardio electrode patch at an inner electrode 21; referring to fig. 6 and 7, a third embodiment of the present invention discloses an electrocardiographic electrode patch including an insulating film 10, a plurality of lead wires 20, a plurality of contact electrodes 30, and an anti-interference film 40.
The insulation film 10 is provided with an outer surface, an inner surface and a plurality of penetrating through holes 50, the insulation film 10 is divided into a contact area 11, a first side lead-out area 12 and second side lead-out areas 13 and 14 according to the shape, the through holes 50 are arranged in the contact area 11, the contact area 11 is integrally connected between the first side lead-out area 12 and the second side lead-out areas 13 and 14, the lead wire 20 is printed on the inner surface of the insulation film 10, one end of the lead wire 20 is integrally formed into an inner electrode 21, the other end of the lead wire 20 is integrally formed into a lead electrode 22, the inner electrode 21 is positioned in the contact area 11, each inner electrode 21 covers one or more through holes 50, the lead electrodes 22 are dispersed in the first side lead-out area 12 and the second side lead-out areas 13 and 14, the distance between the lead electrodes 22 is larger than that between the inner electrodes 21, the contact electrode 30 is printed on the outer surface of the insulation film 10, the other end of the lead wire 20 is integrally formed into a lead electrode 22, the inner electrode 40 is arranged on the contact area 30 corresponding to the inner electrode 40, the inner electrode 40 is covered by the contact area 40, and the inner electrode 50 is covered by the contact area 40. Referring to fig. 7, the anti-interference film 40 may cover the inner electrode 21. Therefore, the anti-interference film 40 covers the inner electrode 21, so that the inner electrode 21 has better positioning and shielding effects on the inner surface, so as to avoid sliding or loosening of the inner electrode 21.
In summary, the invention proposes a disposable anti-interference electrode sheet by utilizing one or more embodiments, through independent innovation research and test, in the best embodiment, a lead wire of the printed electrocardio electrode sheet which adopts a duplex multilayer printing technology and a composite technology is preferably but not exclusively used as a basic signal acquisition transmission layer and is clamped between an insulating film and an anti-interference film, the patch adopts a polyester film which is independently and innovatively researched and developed to print nano silver paste for a printing base layer, a duplex double-sided conduction technology is formed through a via hole, a nano silver paste lead wire is printed on one side of the film, a nano silver prize via hole lead point is printed on the other side of the film, and a layer of silver chloride paste is printed on the basis as a contact electrode for electrode signal acquisition; the surface of the nano silver paste lead wire layer is adhered with a polyester film for protecting and shielding the nano silver paste lead wire formed by printing by adopting a composite process, and the nano silver paste lead wire layer is used as an anti-interference film. The preparation method of the invention innovatively realizes the separation of the electrode signal acquisition layer and the lead wire layer, the design can avoid mutual interference of own signals, and in addition, as the nano silver paste lead layer is arranged on the other surface, the signal interference generated by the local contact of the lead wire with the skin surface is avoided; the surface of the nano silver paste lead wire layer is adhered with a polyester film by adopting a composite technology for protecting and printing a nano silver paste shielding layer, and the shielding layer can effectively isolate external signal interference and ionizing radiation. Through the technical scheme, the three anti-interference designs of the electrode plate, namely the anti-interference, the anti-interference of a user and the anti-interference of an external environment are achieved, and the anti-interference effect is effectively achieved.
The embodiments of the present invention are all preferred embodiments for easy understanding or implementation of the technical solution of the present invention, and are not limited in scope by the present invention, and all equivalent changes according to the structure, shape and principle of the present invention should be covered in the scope of the claimed invention.
Claims (20)
1. An electrocardio electrode patch, comprising:
an insulating film (10) having an outer surface, an inner surface and a plurality of through vias (50), wherein the insulating film (10) is divided into a contact region (11), a first side lead-out region (12) and second side lead-out regions (13, 14) according to a shape region, the through vias (50) are arranged in the contact region (11), and the contact region (11) is integrally connected between the first side lead-out region (12) and the second side lead-out regions (13, 14);
a plurality of lead wires (20) printed on the inner surface of the insulating film (10), one end of the lead wires (20) integrally forming an inner electrode (21), the other end of the lead wires (20) integrally forming an extraction electrode (22), the inner electrode (21) being located in the contact region (11), each inner electrode (21) covering one or more of the via holes (50), the extraction electrodes (22) being dispersed at the first side extraction region (12) and the second side extraction region (13, 14) such that a pitch between the extraction electrodes (22) is larger than a pitch between the inner electrodes (21);
a plurality of contact electrodes (30) printed on the outer surface of the insulating film (10), the contact electrodes (30) being centrally located within the contact region (11) and corresponding to the inner electrodes (21), each contact electrode (30) covering one or more of the vias (50) and electrically connecting the corresponding inner electrode (21) through the via (50); and
The anti-interference film (40) is attached to the inner surface of the insulating film (10), and a signal shielding structure (41) is arranged on the anti-interference film (40) and covers the line section of the lead wire (20).
2. The electrocardio-electrode patch of claim 1, further comprising: a limit coating (60) printed on the inner surface of the insulating film (10), the limit coating (60) being isolated between the line sections adjacent to the lead lines (20); alternatively, when the second side lead-out regions (13, 14) are plural and are serially led out from the contact region (11), a gap between line sections adjacent to the lead lines (20) on a section between the contact region (11) and the second side lead-out region (13) that is relatively adjacent is larger than the thickness of the insulating film (10).
3. The electrocardio electrode patch according to claim 2, characterized in that a gap of a line section adjacent to the lead line (20) is 0.015mm or more.
4. The electrocardio-electrode patch of claim 1, further comprising: and an insulating ink layer (70) printed on the inner surface of the anti-interference film (40).
5. The electrocardio-electrode patch according to claim 4, characterized in that the printed thickness of the insulating ink layer (70) is between 15 and 25 μm.
6. The electrocardio-electrode patch according to claim 1, characterized in that the contact electrode (30) comprises a lead pad layer (31) and a contact layer (32), the lead pad layer (31) being located on the outer surface of the insulating film (10), the contact layer (32) being located on the lead pad layer (31).
7. The electrocardio-electrode patch of claim 6 wherein the inner electrode (21) is uncovered by the anti-interference film (40).
8. The electrocardio-electrode patch according to claim 6, characterized in that the anti-interference film (40) covers the inner electrode (21).
9. The electrocardio-electrode patch of claim 1 wherein the signal shielding structure (41) is printed on the membrane inner face of the anti-interference membrane (40).
10. The electrocardio electrode patch of claim 9, wherein the contour profile of the signal shielding structure (41) corresponds to a line section of the lead wire (20) and the width of the signal shielding structure (41) is greater than the width of the line section of the lead wire (20).
11. The electrocardio-electrode patch of claim 10, wherein the signal shielding structure (41) comprises shielding lines, shielding points or a combination thereof.
12. The electrocardio-electrode patch of any one of claims 1-10, wherein the via (50) comprises a central hole (51) and a plurality of peripheral holes (52) surrounding the central hole (51) corresponding to each inner electrode (21), the distance from the peripheral holes (52) to the central hole (51) being smaller than the radius of the inner electrode (21); the diameter of the via hole (50) is 0.015-0.15 mm.
13. The electrocardio-electrode patch of claim 12 wherein the via (50) has a diameter of 0.015 to 0.05 mm.
14. The electrocardio-electrode patch according to claim 12, characterized in that the thickness of the polyester film of the insulating film (10) is 0.025-0.1. 0.1 mm; the silver paste coating thickness of the lead wire (20) is 4-12 mu m; the line width of the line section of the lead line (20) is between 0.2 and 1.2 and mm.
15. The electrocardiographic electrode patch according to claim 14, wherein the arrangement direction of the plurality of inner electrodes (21) is perpendicular to the arrangement direction of the plurality of extraction electrodes (22).
16. The preparation method of the electrocardio electrode patch is characterized by comprising the following steps of:
providing an insulating film (10), wherein the insulating film (10) is provided with an outer surface, an inner surface and a plurality of penetrating through holes (50), the insulating film (10) is divided into a contact area (11), a first side lead-out area (12) and second side lead-out areas (13, 14), the through holes (50) are arranged in the contact area (11), and the contact area (11) is integrally connected between the first side lead-out area (12) and the second side lead-out areas (13, 14);
-forming a plurality of lead lines (20) on the inner surface of the insulating film (10) by first printing, wherein one ends of the lead lines (20) are formed into inner electrodes (21), the other ends of the lead lines (20) are formed into extraction electrodes (22), the inner electrodes (21) are positioned in the contact areas (11), each inner electrode (21) covers one or more of the via holes (50), and the extraction electrodes (22) are dispersed in the first side extraction areas (12) and the second side extraction areas (13, 14) such that the spacing between the extraction electrodes (22) is larger than the spacing between the inner electrodes (21);
-forming a plurality of contact electrodes (30) on the outer surface of the insulating film (10) by a second printing, the contact electrodes (30) being located within the contact areas (11) and corresponding to the inner electrodes (21), each contact electrode (30) covering one or more of the vias (50) and electrically connecting the corresponding inner electrode (21) through the via (50); and
And an anti-interference film (40) is attached to the inner surface of the insulating film (10), and a signal shielding structure (41) is arranged on the inner surface of the anti-interference film (40) to cover the line section of the lead wire (20).
17. The method of manufacturing an electrocardiographic electrode patch according to claim 16, wherein the via (50) includes a central hole (51) and a plurality of peripheral holes (52) surrounding the central hole (51) corresponding to each internal electrode (21), and a distance from the peripheral holes (52) to the central hole (51) is smaller than a radius of the internal electrode (21).
18. The method of manufacturing an electrocardiographic electrode patch according to claim 17, wherein the diameter of the via hole (50) is 0.015-0.15 mm.
19. The method of manufacturing an ecg electrode patch according to claim 18, wherein the diameter of the via hole (50) is between 0.015 and 0.05-mm.
20. The method for producing an electrocardiographic electrode patch according to claim 17, characterized in that the polyester film thickness of the insulating film (10) is 0.025 to 0.1. 0.1 mm; the silver paste coating thickness of the lead wire (20) is 4-12 mu m; the line width of the line section of the lead line (20) is between 0.2 and 1.2 and mm.
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| CN111615256B (en) * | 2020-06-10 | 2024-06-21 | 深圳市璞瑞达薄膜开关技术有限公司 | Double-sided conducting circuit film without exposed hole and manufacturing method thereof |
| WO2023070571A1 (en) * | 2021-10-29 | 2023-05-04 | 深圳迈瑞动物医疗科技股份有限公司 | Electrocardiogram electrode patch |
| CN114222438A (en) * | 2021-12-13 | 2022-03-22 | 浙江帝诺医疗科技有限公司 | Electrode paste production method and electrode paste |
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| DE29620395U1 (en) * | 1996-02-11 | 1997-01-23 | Bedrich, Michael R., Dipl.-Phys., 01445 Radebeul | Body electrode system |
| US6076003A (en) * | 1998-05-01 | 2000-06-13 | R.Z. Comparative Diagnostics Ltd. | Electrocardiography electrodes holder and monitoring set |
| JP2000126145A (en) * | 1998-10-28 | 2000-05-09 | Omron Corp | Electrocardiograph measurement, and electrode for organism |
| JP5451606B2 (en) * | 2007-07-06 | 2014-03-26 | コーニンクレッカ フィリップス エヌ ヴェ | Shielded biomedical electrode patch |
| US9700222B2 (en) * | 2011-12-02 | 2017-07-11 | Lumiradx Uk Ltd | Health-monitor patch |
| CN202920181U (en) * | 2012-10-18 | 2013-05-08 | 深圳市美的连电子科技有限公司 | Disposable electrocardio electrode |
| CN103815899B (en) * | 2014-03-07 | 2017-01-11 | 华中科技大学 | Non-contacting electrocardio electrode module and electrocardiogram detector |
| CN105640544A (en) * | 2016-03-18 | 2016-06-08 | 青岛光电医疗科技有限公司 | Disposable noise-resistant shielding electrode |
| JP7126672B2 (en) * | 2017-10-05 | 2022-08-29 | 株式会社アイ・メデックス | Bioelectrode and electrical connection structure between layers |
| CN107951484A (en) * | 2017-12-01 | 2018-04-24 | 电子科技大学 | A kind of dismountable suppression active dry electrode of motion artifacts fabric electrocardio |
| CN108784688A (en) * | 2018-06-03 | 2018-11-13 | 东北大学 | A kind of flexible non-contact EGC sensor and preparation method thereof |
| CN209018732U (en) * | 2018-07-23 | 2019-06-25 | 山东正心医疗科技有限公司 | A kind of electrocardioelectrode |
| CN110301909B (en) * | 2019-07-23 | 2024-06-04 | 广西师范大学 | Anti-interference flexible bioelectric dry electrode and preparation method thereof |
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