CN113597284A - Biosensor and method for measuring the same - Google Patents
Biosensor and method for measuring the same Download PDFInfo
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- CN113597284A CN113597284A CN202080018415.5A CN202080018415A CN113597284A CN 113597284 A CN113597284 A CN 113597284A CN 202080018415 A CN202080018415 A CN 202080018415A CN 113597284 A CN113597284 A CN 113597284A
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- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
Abstract
The invention provides a biosensor, which comprises a pressure-sensitive adhesive layer, a sensor layer and a sensor layer, wherein the pressure-sensitive adhesive layer is used for being stuck on a biological surface; an electrode disposed on a biological surface-facing adhesion side of the pressure-sensitive adhesive layer so as to be contactable with the biological surface; an electronic device for processing the biological signal obtained by the electrode; and a circuit unit for connecting the electrode to the electronic device, wherein the electrode has a connection surface connected to the circuit unit on a side of attachment to the biological surface.
Description
Technical Field
The present invention relates to biosensors.
Background
Biosensors for measuring biological information such as an electrocardiogram, a pulse, a brain wave, and an electromyogram are used in medical institutions such as hospitals and clinics, nursing facilities, and homes. The biosensor includes a bioelectrode that is brought into contact with a living body to acquire biological information of a subject. When measuring biological information, the biosensor is attached to the skin of a subject, and the bioelectrode is brought into contact with the skin of the subject. The biological information is measured by acquiring an electric signal related to the biological information through the bioelectrode.
As such a biosensor, for example, a biocompatible polymer substrate including a polymer layer having an electrode on one surface is disclosed, and a product obtained by polymerizing dimethylvinyl terminal dimethylsiloxane (DSDT) and tetramethyltetravinylcyclotetrasiloxane (TTC) at a predetermined ratio is used as the polymer layer (for example, see patent document 1). In the biocompatible polymer substrate, the polymer layer is attached to the skin of a human, the electrode detects an electrical voltage signal from the skin of the human from the heart muscle, and the data acquisition module receives and records the electrical voltage signal from the heart muscle.
< Prior Art document >
< patent document >
Patent document 1 Japanese unexamined patent application publication No. 2012-10978
Disclosure of Invention
< problems to be solved by the present invention >
However, since the biocompatible polymer substrate of patent document 1 is used by being attached to the skin of a subject through a polymer layer, the biocompatible polymer substrate may be bent in the thickness direction or the biosensor may be stretched in the surface direction in accordance with the movement of the skin of the subject. Therefore, in the conventional biocompatible polymer substrate, there is a possibility that the electrode is peeled off from the living body or the polymer layer. In addition, since the electrode is peeled off from the biological or polymer layer, there is a possibility that stable conductivity cannot be obtained.
An object of one embodiment of the present invention is to provide a biosensor that is conductive and can suppress peeling between an adhesive layer provided on one surface of an electrode and a biological surface on which the electrode is provided.
< means for solving the problems >
One embodiment of the biosensor of the present invention includes a pressure-sensitive adhesive layer for adhering to a biological surface; an electrode disposed on a biological surface-facing adhesion side of the pressure-sensitive adhesive layer so as to be contactable with the biological surface; an electronic device for processing the biological signal obtained by the electrode; and a circuit unit for connecting the electrode to the electronic device, wherein the electrode has a connection surface connected to the circuit unit on a side of attachment to the biological surface.
< effects of the invention >
One embodiment of the biosensor of the present invention can suppress peeling between an adhesive layer provided on one surface of an electrode and a biological surface on which the electrode is provided, and can have conductivity.
Drawings
Fig. 1 is an exploded view showing an adhesive type biosensor.
Fig. 2 is a view showing a cross section of a completed state corresponding to the a-a view cross section of fig. 1.
Fig. 3 is a perspective view of an electrode according to an embodiment.
Fig. 4 is a partially enlarged plan view of the electrode.
Fig. 5 is a diagram showing a circuit configuration of the attachment type biosensor.
FIG. 6 is a cross-sectional view showing an example of another mode of the patch type biosensor in a finished state corresponding to the cross-sectional view taken along line A-A in FIG. 1.
Fig. 7 is a perspective view showing an example of another configuration of the electrode.
Fig. 8 is a perspective view showing an example of another configuration of the electrode.
Fig. 9 is a graph showing a relationship between the opening ratio and the peel adhesion.
Fig. 10 is a graph showing a relationship between the number of holes and peel adhesion.
FIG. 11 is a graph showing the relationship between the number of holes and the elongation at break in examples 2-1 to 2-4.
Detailed Description
Hereinafter, embodiments of the present invention will be described in detail. In the drawings, the same components are denoted by the same reference numerals, and redundant description thereof is omitted, so that the description can be easily understood. In addition, the scale of each member in the drawings may be different from that in reality. In this specification, a three-dimensional rectangular coordinate system in three axes (X axis direction, Y axis direction, Z axis direction) is used, coordinates in the main surface of the electrode are set to the X axis direction and the Y axis direction, and a height direction (thickness direction) is set to the Z axis direction. The direction from the bottom to the top of the electrode was set to the + Z-axis direction, and the opposite direction was set to the-Z-axis direction. In the following description, for convenience of explanation, the + Z axis direction is referred to as upper side or upper side, and the-Z axis direction is referred to as lower side or lower side, but these do not indicate a general vertical relationship. In the present specification, the wavy line "to" indicating a numerical range indicates that the numerical values recited before and after the lower limit and the upper limit are included, unless otherwise specified.
< biosensor >
A biosensor according to an embodiment will be described. In the present embodiment, a case of a patch type biosensor that is brought into contact with a living body to measure biological information will be described as an example. The term "living organism" refers to a human body (human), and animals such as cattle, horses, pigs, chickens, dogs, and cats. The biosensor is attached to a part of the living being (e.g., skin, scalp, forehead, etc.). The biosensor is used for a living body, and can be suitably used for a human body.
Fig. 1 is an exploded view showing an adhesive type biosensor 100 according to an embodiment. Fig. 2 is a view showing a cross section of a completed state corresponding to the a-a view cross section of fig. 1. As shown in fig. 1 and 2, the adhesive biosensor 100 according to one embodiment includes, as main constituent elements, a pressure-sensitive adhesive layer 110, a base material layer 120, a circuit portion 130, a substrate 135, a probe 140, a fixing tape 145, an electronic device 150, a battery 160, and a case 170. Hereinafter, each member constituting the attachment type biosensor 100 will be described.
The adhesive biosensor 100 is a sheet-like member having a substantially elliptical shape in plan view. In the adhesive biosensor 100, the lower surface (-Z direction side surface) and the opposite upper surface side of the skin 200 of a living body are covered with the case 170. The lower surface of the attachment type biosensor 100 is an attachment surface.
The pressure-sensitive adhesive layer 110 is a flat plate-shaped adhesive layer. The length direction of the pressure-sensitive adhesive layer 110 is the X-axis direction, and the width direction is the Y-axis direction. The pressure-sensitive adhesive layer 110 is supported by the base material layer 120 and is bonded to the lower surface 121 of the base material layer 120.
As shown in fig. 2, the pressure-sensitive adhesive layer 110 has an upper surface 111 and a lower surface 112. The upper surface 111 and the lower surface 112 are flat surfaces. The pressure-sensitive adhesive layer 110 is a layer of the adhesive type biosensor 100 that is in contact with a living organism. Since the lower surface 112 has pressure-sensitive adhesiveness, it can be adhered to the skin 200 of a living being. The lower surface 112 is a lower surface of the adhesive biosensor 100, and can be adhered to a biological surface such as the skin 200.
The material of the pressure-sensitive adhesive layer 110 is not particularly limited as long as it has pressure-sensitive adhesiveness, and examples thereof include materials having biocompatibility. Examples of the material of the pressure-sensitive adhesive layer 110 include an acrylic pressure-sensitive adhesive, a silicone-based pressure-sensitive adhesive, and the like. Acrylic pressure-sensitive adhesives can be preferably cited.
The acrylic pressure-sensitive adhesive contains an acrylic polymer as a main component.
Acrylic polymers are pressure sensitive adhesive components. As the acrylic polymer, a polymer obtained by polymerizing a monomer component containing, as an optional component, a monomer copolymerizable with a (meth) acrylate such as acrylic acid, and the like, and containing, as a main component, a (meth) acrylate such as isononyl acrylate or methoxyethyl acrylate, can be used. The content of the monomer component of the main component is 70 to 99% by mass, and the content of the monomer component of any component is 1 to 30% by mass. As the acrylic polymer, for example, a (meth) acrylic acid ester polymer described in Japanese patent application laid-open No. 2003-342541, and the like can be used.
The acrylic pressure-sensitive adhesive preferably further contains a carboxylic acid ester.
The carboxylic acid ester contained in the acrylic pressure-sensitive adhesive reduces the pressure-sensitive adhesive force of the acrylic polymer, and is a pressure-sensitive adhesive force adjuster for adjusting the pressure-sensitive adhesive force of the pressure-sensitive adhesive layer 110. The carboxylic acid ester is a carboxylic acid ester which is compatible with the acrylic polymer.
Specifically, the carboxylic acid ester is fatty acid triglyceride as an example.
The content of the carboxylic acid ester is preferably 30 to 100 parts by mass, more preferably 50 to 70 parts by mass or less, per 100 parts by mass of the acrylic polymer.
The acrylic pressure-sensitive adhesive may have a crosslinking agent as needed. The crosslinking agent is a crosslinking component for crosslinking the acrylic polymer. Examples of the crosslinking agent include polyisocyanate compounds, epoxy compounds, melamine compounds, peroxides, urea compounds, metal alkoxide compounds, metal chelates, metal salt compounds, carbodiimide compounds, oxazoline compounds, aziridine compounds, and amine compounds. These crosslinking agents may be used alone or in combination. The crosslinking agent is preferably a polyisocyanate compound (polyfunctional isocyanate compound).
The content of the crosslinking agent is preferably 0.001 to 10 parts by mass, more preferably 0.01 to 1 part by mass, based on 100 parts by mass of the acrylic polymer.
It is preferable that the pressure-sensitive adhesive layer 110 have excellent biocompatibility. For example, when the pressure-sensitive adhesive layer 110 is subjected to a keratolytic test, the keratolytic area ratio is preferably 0% to 50%, more preferably 1% to 15%. When the keratin peeling area ratio is in the range of 0% to 50%, the load on the skin 200 (see fig. 2) can be suppressed even when the pressure-sensitive adhesive layer 110 is stuck to the skin 200 (see fig. 2). The test for exfoliation of keratin was carried out by the method described in Japanese patent application laid-open No. 2004-83425.
It is preferable that the pressure-sensitive adhesive layer 110 have a moisture permeability of 300 (g/m)2Day), more preferably 600 (g/m)2Day), more preferably 1000 (g/m)2/day) above. If the moisture permeability of the pressure-sensitive adhesive layer 110 is 300 (g/m)2And day) or more, the load on the skin 200 (see fig. 2) can be suppressed even when the pressure-sensitive adhesive layer 110 is stuck to the skin 200 (see fig. 2) of a living being.
The pressure-sensitive adhesive layer 110 has a keratolytic area ratio of 50% or less and a moisture permeability of 300 (g/m) satisfying the keratolytic test2/day) so that the pressure-sensitive adhesive layer 110 has biocompatibility. More preferably, the material of the pressure-sensitive adhesive layer 110 satisfies the above two conditions. Thus, the pressure-sensitive adhesive layer 110 is more stable with higher biocompatibility.
It is preferable that the thickness between the upper surface 111 and the lower surface 112 of the pressure-sensitive adhesive layer 110 is 10 μm to 300 μm. When the thickness of the pressure-sensitive adhesive layer 110 is 10 μm to 95 μm, the thickness of the adhesive biosensor 100, particularly the thickness of the region other than the electronic device 150 in the adhesive biosensor 100, can be reduced.
The base material layer 120 is a support layer for supporting the pressure-sensitive adhesive layer 110, and the pressure-sensitive adhesive layer 110 is adhered to the lower surface 121 of the base material layer 120. Circuit unit 130 and substrate 135 are disposed on the upper surface side of base material layer 120.
The base material layer 120 is a flat (sheet-like) member made of an insulator. The shape of the base material layer 120 in plan view is the same as the shape of the pressure-sensitive adhesive layer 110 in plan view, and the base material layer and the pressure-sensitive adhesive layer are aligned and overlapped in plan view.
The thickness of the base material layer 120 is preferably 1 μm to 300 μm, more preferably 5 μm to 100 μm, and still more preferably 10 μm to 50 μm.
The circuit unit 130 includes a wiring 131, a frame 132, and a substrate 133, and connects the probe 140 and the electronic device 150. The attachment type biosensor 100 includes two such circuit portions 130. The wiring 131 and the frame 132 are integrally formed on the upper surface of the substrate 133. The wiring 131 connects the frame 132 with the electronic device 150 and the battery 160. The circuit unit 130 is connected to the probe 140 on the side opposite to the attachment side to the surface of the skin 200 (+ Z-axis direction). The connection portion of the circuit unit 130 to the probe 140 is disposed on the side opposite to the attachment side of the probe 140 to the surface of the skin 200 (+ Z-axis direction).
The wiring 131 and the frame 132 may be made of copper, nickel, gold, or an alloy thereof. The thickness of the wiring 131 and the frame 132 is preferably 0.1 to 100. mu.m, more preferably 1 to 50 μm, and still more preferably 5 to 30 μm.
The two circuit portions 130 are provided corresponding to the two through holes 113 and 123 of the pressure-sensitive adhesive layer 110 and the base material layer 120, respectively. The wiring 131 is connected to the electronic device 150 and the terminal 135A for the battery 160 through the wiring of the substrate 135. The frame 132 is a rectangular ring-shaped conductive member larger than the opening of the through hole 123 of the base material layer 120.
The substrate 133 has the same shape as the wiring 131 and the frame 132 in a plan view. The portion of the substrate 133 where the frame 132 is provided has a rectangular ring shape larger than the opening of the through-hole 123 of the base material layer 120. The frame 132 and the rectangular ring-shaped portion of the substrate 133 where the frame 132 is provided are provided so as to surround the through hole 123 on the upper surface of the base material layer 120. The substrate 133 may be formed of an insulator material, and for example, a substrate or a thin film formed of polyimide or the like can be used. Since the base material layer 120 has adhesiveness (tackiness), the substrate 133 is fixed to the upper surface of the base material layer 120.
The substrate 135 is formed of an insulator material for mounting the electronic device 150 and the battery 160, and is provided on the upper surface 122 of the base material layer 120. The substrate 135 is fixed by the tackiness (tackiness) of the base material layer. As the substrate 135, a substrate or a thin film made of polyimide or the like can be used as an example. On the upper surface of the substrate 135, a terminal 135A for wiring and the battery 160 is provided. The wiring of the substrate 135 is connected to the electronic device 150 and the terminal 135A, and is also connected to the wiring 131 of the circuit portion 130.
The probe 140 is provided in a state where it is pressed into the inner walls of the through holes 113 and 123 from the upper surface (+ Z-axis direction surface) of the periphery of the through hole 123 of the base material layer 120 along the inner walls of the through holes 113 and 123 by the pressure-sensitive adhesive layer 110A. As described above, the probe 140 is provided so as to be exposed from the lower surface 112 of the pressure-sensitive adhesive layer 110 and embedded in the pressure-sensitive adhesive layer 110A, and is disposed so as to be contactable with the surface of the skin 200 on the adhesion side (-Z axis direction) of the surface of the pressure-sensitive adhesive layer 110 to the skin 200. As for the probe 140, it has an exposed area where a part of the probe 140 is exposed on the adhesion side (-Z axis direction) of the pressure-sensitive adhesive layer 110 with the skin 200. The probe 140 is brought into contact with the skin 200 while the pressure-sensitive adhesive layer 110 is adhered to the skin 200, thereby detecting a biological signal. The biological signal is an electrical signal representing, for example, an electrocardiographic waveform, brain wave, pulse, or the like.
The probe 140 has a connection surface 141 that is located on the upper surface (+ Z-axis direction surface) of the frame 132 of the circuit unit 130 located around the through hole 123 of the base material layer 120 and is connected to the frame 132 of the circuit unit 130 on the side attached to the biological surface (-Z-axis direction). The connection surface 141 may be connected to both the wiring 131 and the frame 132.
The probe 140 is formed in a rectangular shape in plan view, is larger than the through holes 113 and 123 of the pressure-sensitive adhesive layer 110 and the base material layer 120, and has holes 140A arranged in a matrix. At the X-direction and Y-direction ends (square end portions) of the probe 140, ladder-shaped sides of the probe 140 may protrude.
The probe 140 may have a hole 140A over the entire surface of the main surface thereof, and preferably has a hole 140A in the connection surface 141. The probe 140 has holes 140A over the entire main surface thereof or in the periphery of the end portion thereof, so that the holes 140A can be formed in the connection surface 141. By providing the hole 140A in the attachment face 141, the pressure-sensitive adhesive layer 110A can be exposed from the hole 140A formed in the attachment face 141, so that the pressure-sensitive adhesive layer 110A can be easily brought into contact with the upper surface (+ Z-axis direction surface) of the frame 132 of the circuit portion 130.
The probe 140 is formed using an electrode. The electrode will be described with reference to fig. 3 and 4. In fig. 3 and 4, the electrodes correspond to the probes 140 shown in fig. 1 and 2, and the holes of the electrodes correspond to the holes 140A shown in fig. 1 and 2.
(electrode)
Fig. 3 is a perspective view of the electrode. As shown in fig. 3, the electrode 10 is formed with a plurality of holes 13 penetrating in the thickness direction (Z-axis direction) of the electrode 10 in a lattice shape in a plate-like (sheet-like) member having a pair of main surfaces 11 and 12 parallel to each other.
The main surfaces 11 and 12 are each a flat surface. The main surface 11 is one (+ Z-axis direction) main surface of the electrode 10, which is a surface of the electrode 10. The main surface 12 is a main surface located in the opposite direction (the (-Z-axis direction) to the main surface 11, which is the back surface of the electrode 10. Main surfaces 11 and 12 are formed in a rectangular shape in a plan view. In the present embodiment, the rectangular shape means a shape obtained by chamfering corners of a rectangle or a square in addition to a rectangle or a square.
The size of the electrode 10 in a plan view is preferably 5mm to 50 mm.
The thickness of the electrode 10 is preferably 0.1 μm to 100. mu.m. If the thickness of the electrode 10 is 0.1 μm to 100 μm, the electrode 10 has strength and is easy to handle.
The plurality of holes 13 are arranged in a square lattice shape on the main surface 11, and are aligned in two intersecting axial directions (X-axis direction, Y-axis direction) at substantially equal intervals on the main surface 11. All the holes 13 are formed to have substantially the same size and shape. It should be noted that the plurality of holes 13 may not be equally spaced.
As shown in fig. 4, the hole 13 is formed in a circular shape in a plan view. The diameter L of the hole 13 can be suitably designed according to the size of the main surface 11, and is preferably 100nm to 10mm, more preferably 300nm to 5mm, and further preferably 600 μm to 2 mm. Note that the shape of the hole 13 may be an ellipse. When the shape of the hole 13 is an ellipse, the diameter L of the hole 13 preferably has the above-mentioned value as the major axis.
The distance P between the holes 13 varies depending on the shape, size, etc. of the holes 13, and is preferably 100nm to 10mm, more preferably 300nm to 5mm, and further preferably 600nm to 2mm or less. The distance P between the holes 13 means the shortest distance between the adjacent holes 13. Since the holes 13 are formed in a circular shape in a plan view, the distance between the holes 13 means the interval between the closest points of the adjacent holes 13.
The opening ratio of the holes 13 is 2% to 80%, preferably 10% to 70%, and more preferably 30% to 60%. If the opening ratio of the hole 13 is less than 2%, the area of the adhesive layer exposed from the hole 13 of the electrode 10 is small when the adhesive layer is provided on the electrode 10. Therefore, when the adhesive layer is peeled together with the electrode 10 from the adhesive surface, the peeling adhesion of the adhesive layer to the adhesive surface becomes excessively small. If the opening ratio of the hole 13 exceeds 80%, the area of the adhesive layer exposed from the hole 13 of the electrode 10 becomes too large. Therefore, when the adhesive layer is peeled off together with the electrode 10 from the adhesive surface, the adhesive force becomes excessively strong.
The open porosity is a ratio of the sum of the areas of the holes 13 to the total area of the main surface (main surface 11 or main surface 12) of the electrode 10 including the area of the holes 13, and is represented by the following formula (1).
Opening ratio (%) (sum of areas of the holes 13) (cm)2) Area of the entire main surface (main surface 11 or main surface 12) of electrode 10 including area of hole 13 (cm)2)×100…(1)
Preferably, the number of holes 13 is 2000/cm2Hereinafter, more preferably 1000 pieces/cm2Hereinafter, more preferably 500 pieces/cm2The following. If the number of holes 13 is 2000/cm2When the adhesive layer is provided on the electrode 10, the number of adhesive layers exposed from the hole 13 of the electrode 10 can be sufficiently secured, and the electrical conductivity can be easily maintained. The lower limit value of the number of holes 13 may be two or more.
The electrode 10 may be formed using a conductive composition including a conductive polymer and a binder resin.
As the conductive polymer, for example, polythiophene, polyacetylene, polypyrrole, polyaniline, polystyrene, or the like can be used. These may be used alone or in combination of two or more. Among them, a polythiophene compound is preferably used. PEDOT/PSS obtained by doping poly (4-styrenesulfonate; PSS) with poly (3, 4-ethylenedioxythiophene) (PEDOT) is more preferable because of its low contact resistance with living organisms and high conductivity.
The content of the conductive polymer is preferably 0.20 to 20 parts by mass, more preferably 2.5 to 15 parts by mass, and still more preferably 3.0 to 12 parts by mass, based on 100 parts by mass of the conductive composition. When the content is in the range of 0.20 to 20 parts by mass relative to the conductive composition, the conductive composition can have excellent conductivity, toughness and flexibility.
As the conductive polymer, an aqueous solution dissolved in a solvent can be used. In this case, an organic solvent or an aqueous solvent can be used as the solvent. Examples of the organic solvent include ketones such as acetone and Methyl Ethyl Ketone (MEK), esters such as ethyl acetate, ethers such as propylene glycol monomethyl ether, and amines such as N, N-dimethylformamide. Examples of the aqueous solvent include water and alcohols such as methanol, ethanol, propanol, and isopropanol. Among these, an aqueous solvent is preferably used.
As the binder resin, a water-soluble polymer, a water-insoluble polymer, or the like can be used. The binder resin is preferably a water-soluble polymer from the viewpoint of compatibility with other components contained in the conductive composition. The water-soluble polymer includes a polymer (hydrophilic polymer) which is not completely soluble in water and has hydrophilicity.
As the water-soluble polymer, a hydroxyl group-containing polymer or the like can be used. Examples of the hydroxyl group-containing polymer include saccharides such as agarose, polyvinyl alcohol (PVA), modified polyvinyl alcohol, and copolymers of acrylic acid and sodium acrylate. These may be used alone or in combination of two or more. Among these, polyvinyl alcohol or modified polyvinyl alcohol is preferable, and modified polyvinyl alcohol is more preferable.
Examples of the modified polyvinyl alcohol include acetoacetyl-containing polyvinyl alcohol and diacetone acrylamide-modified polyvinyl alcohol. The diacetone acrylamide-modified polyvinyl alcohol may be, for example, a diacetone acrylamide-modified polyvinyl alcohol resin (DA-modified PVA-based resin) described in Japanese patent application laid-open No. 2016-166436.
The content of the binder resin is preferably 5 to 140 parts by mass, more preferably 10 to 100 parts by mass, and still more preferably 20 to 70 parts by mass, based on 100 parts by mass of the conductive composition. When the content is in the range of 5 to 140 parts by mass relative to the conductive composition, the conductive composition can have excellent conductivity, toughness and flexibility.
The binder resin may be an aqueous solution dissolved in a solvent. As the solvent, the same solvents as in the case of the conductive polymer described above can be used.
Preferably, the conductive composition further includes at least one of a crosslinking agent and a plasticizer. The crosslinking agent and the plasticizer have a function of imparting toughness and flexibility to the conductive composition.
The toughness is a property of satisfying both excellent strength and elongation. Toughness does not include properties where one of strength and elongation is significantly excellent and the other is significantly lower, including properties where the balance of both strength and elongation is excellent.
Flexibility is a property that can suppress damage such as breakage from occurring in a bent portion after bending an electrode 10 that is a cured product of a conductive composition.
The crosslinking agent crosslinks the binder resin. By containing a crosslinking agent in the binder resin, the toughness of the conductive composition can be improved. Preferably, the crosslinking agent has reactivity with hydroxyl groups. If the crosslinking agent has reactivity with a hydroxyl group, the crosslinking agent can react with a hydroxyl group of the hydroxyl group-containing polymer in the case where the binder resin is a hydroxyl group-containing polymer.
Examples of the crosslinking agent include zirconium compounds such as zirconium salts, titanium compounds such as titanium salts, borides such as boric acid, isocyanate compounds such as blocked isocyanate, aldehyde compounds such as glyoxal, alkoxy group-containing compounds, and methylol group-containing compounds. These may be used alone or in combination of two or more. Among them, a zirconium compound, an isocyanate compound or an aldehyde compound is preferable from the viewpoint of reactivity and safety.
The content of the crosslinking agent is preferably 0.2 to 80 parts by mass, more preferably 1 to 40 parts by mass, and still more preferably 3.0 to 20 parts by mass, based on 100 parts by mass of the conductive composition. When the content is in the range of 0.2 to 80 parts by mass per 100 parts by mass of the conductive composition, excellent toughness and flexibility can be imparted to the conductive composition.
The crosslinking agent may be an aqueous solution dissolved in a solvent. As the solvent, the same solvents as in the case of the conductive polymer described above can be used.
The plasticizer improves the tensile elongation and flexibility of the conductive composition. Examples of the plasticizer include polyhydric alcohol compounds such as glycerin, ethylene glycol, propylene glycol, sorbitol, and polymers thereof, aprotic compounds such as N-methylpyrrolidone (NMP), dimethyl formamide (DMF), N-N' -dimethylacetamide (DMAc), and dimethyl sulfoxide (DMSO), and the like. These may be used alone or in combination of two or more. Among them, glycerin is preferred from the viewpoint of compatibility with other components.
The content of the plasticizer is preferably 0.2 to 150 parts by mass, more preferably 1.0 to 90 parts by mass, and still more preferably 10 to 70 parts by mass, based on 100 parts by mass of the conductive composition. When the content is in the range of 0.2 to 150 parts by mass per 100 parts by mass of the conductive composition, excellent toughness and flexibility can be imparted to the conductive composition.
At least one of the crosslinking agent and the plasticizer may be contained in the conductive composition. When at least one of the crosslinking agent and the plasticizer is contained in the conductive composition, the toughness and flexibility of the electrode 10 can be improved.
When the conductive composition contains the crosslinking agent and does not contain the plasticizer, the electrode 10 can further improve both the toughness, i.e., the tensile strength and the tensile elongation, and can improve the flexibility.
When the conductive composition contains a plasticizer and does not contain a crosslinking agent, the tensile elongation of the electrode 10 can be improved, and therefore, the toughness of the electrode 10 as a whole can be improved. In addition, the flexibility of the electrode 10 can be improved.
Preferably, both the crosslinking agent and the plasticizer are contained in the conductive composition. The inclusion of both the crosslinking agent and the plasticizer in the conductive composition imparts further excellent toughness to the electrode 10.
The conductive composition may contain, as required, various known additives such as a surfactant, a softening agent, a stabilizer, a leveling agent, an oxidation inhibitor, a hydrolysis inhibitor, a swelling agent, a thickener, a colorant, and a filler in an arbitrary ratio in addition to the above components. Examples of the surfactant include silicone surfactants.
The conductive composition is prepared by mixing the above components in the above proportions.
The conductive composition may contain a solvent at an arbitrary ratio as needed. Thus, an aqueous solution of the conductive composition (conductive composition aqueous solution) was prepared.
As the solvent, an organic solvent or an aqueous solvent can be used. Examples of the organic solvent include ketones such as acetone and Methyl Ethyl Ketone (MEK), esters such as ethyl acetate, ethers such as propylene glycol monomethyl ether, and amines such as N, N-dimethylformamide. Examples of the aqueous solvent include water and alcohols such as methanol, ethanol, propanol, and isopropanol. Among them, an aqueous solvent is preferably used.
An example of a method for manufacturing the electrode 10 will be described. After the conductive composition is applied to the surface of the release substrate, the conductive composition is heated, and a crosslinking reaction of the binder resin is caused to proceed by the crosslinking agent contained in the conductive composition, thereby curing the binder resin. Thereby, a cured product of the conductive composition can be obtained. Then, the surface of the cured product is pressed into a predetermined shape by a press or the like to be molded. This makes it possible to obtain the electrode 10 shown in fig. 3, in which the holes 13 having substantially the same size and shape are arranged in a square lattice pattern on the main surface 11.
As the release base material, a separator (separator), a core material, or the like can be used. As the separator, a resin film such as a polyethylene terephthalate (PET) film, a Polyethylene (PE) film, a polypropylene (PP) film, a Polyamide (PA) film, a Polyimide (PI) film, or a fluororesin film can be used. As the core material, a resin film such as a PET film or a PI film, a ceramic sheet, a metal film such as an aluminum foil, a resin substrate reinforced with glass fibers, plastic nonwoven fibers, or the like, a silicon substrate, a glass substrate, or the like can be used.
As a method for applying the conductive composition onto the release substrate, a method based on roll coating, screen coating, gravure coating, spin coating, reverse coating, bar coating, blade coating, air knife coating, dipping, distribution coating, or the like, a method in which a small amount of the conductive composition is dropped onto a substrate and spread with a blade, or the like can be used. By these coating methods, the conductive composition is uniformly coated on the release substrate.
As a method for heating the conductive composition, a known dryer such as a drying oven, a vacuum oven, an air circulation oven, a hot air dryer, a far infrared ray dryer, a microwave vacuum dryer, or a high frequency dryer can be used.
The heating conditions may be any conditions that allow the crosslinking agent contained in the aqueous solution of the conductive composition to react.
The heating temperature of the aqueous conductive composition solution is set to a temperature at which the reaction of the crosslinking agent contained in the aqueous conductive composition solution can proceed. The heating temperature is preferably 100 to 200 ℃ and more preferably 110 to 150 ℃. When the heating temperature is in the range of 100 to 200 ℃, the reaction of the crosslinking agent is easily progressed, and the curing of the binder resin can be accelerated.
The heating time of the aqueous solution of the conductive composition is preferably 0.5 to 300 minutes, more preferably 5 to 120 minutes. When the heating time is in the range of 0.5 to 300 minutes, the binder resin can be sufficiently cured.
In this way, the electrode 10 is a sheet-like electrode having the main surfaces 11 and 12, and has a plurality of holes 13, and the hole opening ratio of the holes 13 in the main surfaces 11 and 12 is set to 8% to 80%. Thus, when the electrode 10 is provided with the pressure-sensitive adhesive layer 110 as an adhesive layer on the main surface 11 side, it is possible to suppress a decrease in adhesive force necessary for the connection of the pressure-sensitive adhesive layer 110 to the skin 200, which is a biological surface in contact with the part to be adhered, through the hole 13 of the electrode 10. Therefore, in the case where the electrode 10 is provided with the pressure-sensitive adhesive layer 110 on the main surface 11 side, the occurrence of peeling between the pressure-sensitive adhesive layer 110 and the skin 200 can be suppressed. The electrode 10 may have a peel adhesion of, for example, 0.010N/10mm or more.
The peel adhesion strength is obtained by, for example, a method according to jis z 0237:2009, a method in which an experimental plate specified in jis z 0237:2009 is changed to another adherend, or the like. The peel adhesion force can be, for example, the peel strength in the case where the electrode 10 is adhered to an experimental plate, an adherend, and a peel experiment is performed at a tensile speed of 300 mm/min and a peel angle of 180 °. The peel adhesion is preferably 0.010N/10mm to 0.8N/10mm, more preferably 0.080N/10mm to 0.55N/10 mm. If the peel adhesion is less than 0.010N/10mm, the pressure-sensitive adhesive layer 110 may have a low adhesion to the skin 200 and may be insufficiently adhered when the pressure-sensitive adhesive layer 110 is adhered to the electrode 10 for use. When the peel adhesion exceeds 0.8N/10mm, the pressure-sensitive adhesive layer 110 may have a high adhesion, which may hinder re-adhesion of the pressure-sensitive adhesive layer 110.
In addition, in electrode 10, the area of main surface 11 or main surface 12 in contact with skin 200 can be sufficiently ensured by setting the aperture ratio of holes 13 in main surfaces 11 and 12 to 2% to 80%. Therefore, the electrode 10 can stably maintain electrical conductivity with the skin 200.
Thus, when the pressure-sensitive adhesive layer 110 is provided on the main surface 11 side of the electrode 10, the pressure-sensitive adhesive layer 110 is prevented from peeling from the skin 200 and has conductivity. Therefore, when the electrode 10 is used in a biosensor, the measurement can be performed while preventing the electrode 10 from peeling from the skin for a long time.
The electrode 10 canThe number of holes 13 can be set to 2000/cm2The following. Thus, when the adhesive layer is provided on the electrode 10, the number of adhesive layers exposed from the hole 13 of the electrode 10 can be sufficiently ensured, and the contact area of the electrode 10 with respect to the skin 200 can be maintained. Therefore, when the electrode 10 is provided with the pressure-sensitive adhesive layer 110 on the main surface 11 side, the occurrence of peeling between the pressure-sensitive adhesive layer 110 and the skin 200 can be further suppressed, and the electrical conductivity can be ensured.
The electrodes 10 may be configured such that the holes 13 are arranged in a square lattice pattern on the main surfaces 11 and 12. Thus, when the electrode 10 is provided in the adhesive layer, the adhesive layer can be brought into contact with the skin 200 substantially uniformly over the entire circumference of the electrode 10 through the hole 13 of the electrode 10, and the contact area of the electrode 10 with the skin 200 can be secured substantially uniformly. Thus, when the adhesive layer is provided on the main surface 11 side of the electrode 10, even if the adhesive layer expands and contracts in each direction of the skin 200, the adhesive layer can stably maintain the adhesive force with respect to the skin 200, and can stably maintain the electrical conduction with the skin 200.
The electrode 10 may have a hole 13 penetrating perpendicularly to the main surfaces 11 and 12. This enables the pressure-sensitive adhesive layer 110 to be easily passed through the hole 13 when the pressure-sensitive adhesive layer 110 is provided on the electrode 10. Thereby, the electrode 10 can easily contact the pressure-sensitive adhesive layer 110 with the skin 200 from the hole 13, and can stably maintain the connection of the pressure-sensitive adhesive layer 110 with the skin 200. Further, since the influence of the viscosity of the pressure-sensitive adhesive layer 110 can be reduced, an adhesive layer suitable for the kind of the skin 200 can be used.
As shown in fig. 1 and 2, the probe 140 is fixed to the frame 132 by a fixing band 145 covering the square end portion in a state where the square end portion is disposed on the frame 132. The fixing strap 145 is adhered to the frame 132 through a gap of the hole 140A of the probe 140 and the like.
The securing strap 145 is, as one example, a copper strap, which is rectangular ring-shaped in plan view. The fixing band 145 has adhesive coated on its lower surface. The fixing band 145 is provided on the frame 132 so as to surround four sides of the probe 140 outside the openings of the through holes 113 and 123 in a plan view, and fixes the probe 140 to the frame 132. The fixing tape 145 may be a metal tape other than copper.
In this manner, the pressure-sensitive adhesive layer 110A and the base layer 120A are laminated on the fixing tape 145 and the probe 140 in a state where the four-sided end portions of the probe 140 are fixed to the frame 132 by the fixing tape 145. When the pressure-sensitive adhesive layer 110A and the base material layer 120A are pressed downward, the probe 140 is pressed along the inner walls of the through holes 113 and 123, and the pressure-sensitive adhesive layer 110A is pressed into the hole 140A of the probe 140.
The probe 140 is pressed down to a position substantially flush with the lower surface 112 of the pressure-sensitive adhesive layer 110 in a state where the portions of the four sides of the end are fixed onto the frame 132 by the fixing tape 145. Therefore, when the probe 140 is brought into contact with the skin 200 of a living being (see fig. 2), the pressure-sensitive adhesive layer 110A adheres to the skin 200, and the probe 140 can be brought into close contact with the skin 200.
It is preferable that the thickness of the probe 140 is thinner than that of the pressure-sensitive adhesive layer 110. The thickness of the probe 140 is preferably 0.1 to 100 μm, more preferably 1 to 50 μm, as the thickness of the electrode 10.
The portion (rectangular ring-shaped portion) of the pressure-sensitive adhesive layer 110A surrounding the central portion in plan view is located above the fixing tape 145. In fig. 2, although the upper surface of the pressure-sensitive adhesive layer 110A is substantially flat, the central portion may be recessed below the peripheral portion. The base material layer 120A is superimposed on the substantially flat upper surface of the pressure-sensitive adhesive layer 110A.
The pressure-sensitive adhesive layer 110A and the base layer 120A may be made of the same material as the pressure-sensitive adhesive layer 110 and the base layer 120, respectively. The pressure-sensitive adhesive layer 110A may be made of a material different from that of the pressure-sensitive adhesive layer 110. The base layer 120A may be made of a material different from that of the base layer 120.
In fig. 2, the thicknesses of the respective portions are exaggerated, and actually, the thicknesses of the pressure-sensitive adhesive layers 110 and 110A are 10 to 300 μm, and the thicknesses of the base material layers 120 and 120A are 1 to 300 μm. The thickness of the wiring 131 is 0.1 to 100 μm, the thickness of the substrate 133 is about several 100 μm, and the thickness of the fixing tape 145 is 10 to 300 μm.
As shown in fig. 2, when the probe 140 is in direct contact with the frame 132 to ensure electrical connection, the fixing tape 145 may be a tape made of resin or the like having no conductivity.
In fig. 2, the fixing tape 145 covers the side surfaces of the frame 132 and the substrate 133 in addition to the probe 140, and reaches the upper surface of the base material layer 120. However, the fixing tape 145 may be used to join the probe 140 to the frame 132, and may not reach the upper surface of the base material layer 120, may not cover the side surface of the substrate 133, or may not cover the side surface of the frame 132.
In addition, the substrate 133 and the two substrates 135 may be one substrate integrated. In this case, the wiring 131, the two frames 132, and the terminal 135A are provided on the surface of one substrate, and the electronic device 150 and the battery 160 are mounted.
The electronic device 150 is provided on the upper surface 122 of the base material layer 120, and is electrically connected to the wiring 131. The electronic device 150 has a rectangular shape in cross section. Terminals are provided on the lower surface (-Z direction) of the electronic device 150. Examples of the material of the terminal of the electronic device 150 include solder, conductive paste, and the like.
As shown in fig. 1, the electronic device 150 includes, as an example, an ASIC (application specific integrated circuit) 150A, MPU (Micro Processing Unit)150B, a memory 150C, and a wireless communication Unit 150D, and is connected to the probe 140 and the battery 160 via the circuit Unit 130. The electronics 150 process the bio-signals acquired by the probe 140.
ASIC150A includes an A/D (analog to digital) converter. The electronic device 150 is driven by the power supplied from the battery 160, and acquires a biological signal measured by the probe 140. The electronic device 150 performs processing such as filtering and digital conversion on the biological signal, and the MPU150B calculates an average value of the biological signals acquired a plurality of times and stores the average value in the memory 150C. The electronic device 150 can continuously acquire the bio-signal for 24 hours or more as an example. Since the electronic device 150 may measure a biological signal for a long time, a study for reducing power consumption has been conducted.
The wireless communication unit 150D is a radio transceiver used when the experimental device for the evaluation experiment reads the biological signal stored in the memory 150C by wireless communication in the evaluation experiment, and communicates at 2.4GHz as an example. Evaluation test As an example, a test according to JIS 60601-2-47 was used. The evaluation test is an operation confirmation test performed after completion of a biosensor used as a medical device for detecting a biological signal. The evaluation experiment requires that the decay rate of the bio-signal extracted from the biosensor with respect to the bio-signal input to the biosensor is less than 5%. The evaluation test was conducted on all the completed products.
As shown in fig. 2, the battery 160 is provided on the upper surface 122 of the base material layer 120. As the battery 160, a lead storage battery, a lithium ion secondary battery, or the like can be used. The battery 160 may be a button-type battery. The battery 160 is an example of a secondary battery. The battery 160 has terminals provided on a lower surface thereof. The terminals of the battery 160 are connected to the probe 140 and the electronic device 150 through the circuit portion 130. The capacity of the battery 160 is set, for example, such that the electronic device 150 can measure the biosignal for 24 hours or more.
The case 170 covers the base material layer 120, the circuit portion 130, the substrate 135, the probes 140, the fixing tape 145, the electronic device 150, and the battery 160. The housing 170 includes a base 170A and a protrusion 170B protruding from the center of the base 170A in the + Z direction. The base 170A is a portion located around the housing 170 in a plan view, and is lower than the projection 170B. A recess 170C is provided below the projection 170B. The lower surface of base 170A of housing 170 is bonded to upper surface 122 of substrate layer 120. The substrate 135, the electronic device 150, and the battery 160 are accommodated in the recess 170C. Case 170 is bonded to upper surface 122 of base layer 120 in a state where electronic device 150, battery 160, and the like are accommodated in recess 170C.
The case 170 functions as a case for protecting the circuit unit 130, the electronic device 150, and the battery 160 on the base material layer 120, and also functions as an impact absorbing layer that is applied to the impact-protected internal component of the attachment type biosensor 100 from the upper surface side. As the case 170, for example, silicone rubber, soft resin, urethane, or the like can be used.
Fig. 5 is a diagram showing a circuit configuration of the attachment type biosensor 100. Each probe 140 is connected to the electronic device 150 and the battery 160 via the wiring 131 and the wiring 135B of the substrate 135. Two probes 140 are connected in parallel with respect to the electronics 150 and the battery 160.
In this manner, the attachment biosensor 100 includes the probe 140, and the probe 140 is provided with a connection surface 141 connected to the frame 132 of the circuit portion 130 on the attachment side (-Z axis direction) to the surface of the skin 200. The probe 140 is connected to the frame 132 via the connection surface 141, so that the probe 140 is less likely to be peeled off from the frame 132. Accordingly, the attachment biosensor 100 can stabilize the connection between the probe 140 and the frame 132, and can stably ensure the conduction between the probe 140 and the frame 132. In the attachment biosensor 100, the probe 140 is disposed on the attachment side of the pressure-sensitive adhesive layer 110 to the surface of the skin 200 (in the (-Z-axis direction) so as to be in contact with the surface of the skin 200, and thus can stably have electrical continuity with the skin 200. Thus, the adhesive biosensor 100 can suppress the separation of the pressure-sensitive adhesive layer 110 provided on one surface of the probe 140 and the skin 200 on which the probe 140 is provided, and has conductivity. Therefore, in the adhesive biosensor 100, even when the adhesive biosensor 100 is used for a long time with the adhesive biosensor 100 attached to the skin, the measurement of biological information can be stably performed by the adhesive biosensor 100.
The attachment biosensor 100 has one or more holes 140A on the connection surface 141 of the probe 140, and the circuit part 130 and the probe 140 can be connected to each other on the opposite side (+ Z-axis direction) of the attachment side (-Z-axis direction) of the surface of the skin 200. The probe 140 has a hole 140A in the connection face 141, so that the pressure-sensitive adhesive layer 110A exposed from the hole 140A formed in the connection face 141 can be brought into contact with the upper surface (+ Z-axis direction surface) of the frame 132 of the circuit portion 130. Thereby, the state in which the probe 140 is connected to the frame 132 through the pressure-sensitive adhesive layer 110A can be maintained. Thus, the attachment biosensor 100 can more stably connect the probe 140 and the frame 132 through the pressure-sensitive adhesive layer 110A exposed through the hole 140A formed in the connection surface 141.
The attachment biosensor 100 includes the probe 140 formed using the electrode 10 (see fig. 3), and the probe 140 may have an aperture ratio of 8% to 80%. Thus, the adhesive biosensor 100 can suppress a decrease in the adhesive force of the skin 200 with respect to the pressure-sensitive adhesive layer 110 through the hole 140A of the probe 140, and can suppress the probe 140 from peeling off from the skin 200. In addition, the adhesive biosensor 100 can ensure conductivity in the probe 140, and can stably have conduction with the skin 200. Thus, the adhesive biosensor 100 can more stably suppress the separation between the pressure-sensitive adhesive layer 110 provided on one surface of the probe 140 and the skin 200 on which the probe 140 is provided, and has conductivity. Therefore, in the adhesive biosensor 100, even when the adhesive biosensor 100 is used for a long time with the adhesive biosensor 100 attached to the skin, the measurement of biological information can be stably performed by the adhesive biosensor 100.
The attachment biosensor 100 can set the number of the holes 140A of the probe 140 to 300/cm2The following. This can further suppress the occurrence of peeling between the pressure-sensitive adhesive layer 110 passing through the hole 140A of the probe 140 and the skin 200, and can ensure conductivity. Thus, the adhesive biosensor 100 can be stably used in a state of being adhered to the skin 200 for a long time.
The attachment biosensor 100 may be configured such that the holes 140A of the probes 140 are arranged in a square lattice shape on the main surface. This allows the pressure-sensitive adhesive layer 110 to be brought into contact with the skin 200 substantially uniformly from the hole 140A over the entire circumference of the probe 140, and the contact area between the probe 140 and the skin 200 can be secured substantially uniformly. Therefore, in the attachment type biosensor 100, even if the surface of the skin 200 moves, the skin 200 in contact with the probe 140 expands and contracts in various directions, and the state in which the pressure-sensitive adhesive layer 110 is attached to the skin 200 through the hole 140A of the probe 140 can be stably maintained.
The attachment biosensor 100 can have the hole 140A of the probe 140 vertically penetrating the main surface of the probe 140. Thus, the adhesive biosensor 100 can easily bring the pressure-sensitive adhesive layer 110 into contact with the skin 200 through the hole 140A of the probe 140, and thus can easily form the connection of the pressure-sensitive adhesive layer 110 to the skin 200.
The attachment biosensor 100 is used for measuring biological information, and then is collected as necessary, and can be reused by taking out the electronic device 150 and the battery 160 and exchanging them.
The adhesive biosensor 100 is a measurement device that detects an electrical signal from a living being to measure biological information, and can be used as an adhesive electrocardiograph, an adhesive electroencephalograph, an adhesive blood pressure meter, an adhesive pulsimeter, an adhesive electromyograph, an adhesive thermometer, an adhesive accelerometer, or the like.
Among them, the adhesive biosensor 100 is suitable for use as an adhesive electrocardiograph. In an electrocardiographic examination, the attachment type biosensor 100 acquires a minute action potential (electromotive force) of a cardiac muscle generated by the beating of the heart of a subject as biological information, and thereby examines an electrocardiographic abnormality such as arrhythmia or ischemic heart disease. In the electrocardiographic examination, the adhesive biosensor 100 is attached to the chest, both wrists, both ankles, or the like of a subject, and can stably detect the action potential of the cardiac muscle caused by the beating of the heart of the subject as an electric signal by the probe 140. The attachment type biosensor 100 can more accurately acquire an electrocardiogram waveform by using an electric signal detected by the probe 140.
(alternative mode of biosensor)
As shown in fig. 6, the attachment biosensor 100 may have a moisture barrier layer 115 in the through- holes 113 and 123 instead of the pressure-sensitive adhesive layer 110A.
The moisture barrier layer 115 has a function of suppressing moisture existing around the probe 140 from permeating through the adhesive biosensor 100 in the thickness direction. The moisture barrier layer 115 is formed on the lower surface of the adhesive type biosensor 100 together with the pressure-sensitive adhesive layer 110. By providing the moisture barrier layer 115 around the lower surface of the probe 140, moisture around the probe 140 can be prevented from permeating in the thickness direction of the adhesive biosensor 100, and moisture can be maintained at the interface between the lower surface of the probe 140 and the skin 200 when the probe 140 is brought into contact with the skin 200 of a living being. In addition, since moisture is maintained at the interface between the lower surface of the probe 140 and the skin 200, drying of the probe 140 can be suppressed, and an increase or variation in impedance of the probe 140 due to drying of the surface of the probe 140 can be suppressed.
The moisture barrier layer 115 has a lower moisture permeability than the pressure-sensitive adhesive layer 110 and the base material layer 120. Specifically, the moisture-permeability of the moisture barrier layer 115 is, for example, less than 1000g/m2Day, preferably 600g/m2Day or less, more preferably 300g/m2Day or less, more preferably 80g/m2Day or less, and further, for example, 0.001g/m2Day or more.
Examples of the material of the moisture barrier layer 115 include rubber-based resins (polyisobutylene-based resins, isobutylene-based resins, SBR-based resins, natural rubber/SBR-based resins, and the like), polystyrene-based resins, polyolefin-based resins (polypropylene-based resins, polyethylene-based resin layers), acrylic resins, polyvinyl alcohol-based resins, and the like. These resins may be used alone or in combination of two or more.
The moisture barrier layer 115 may have bubbles. As the moisture barrier layer 115, a polypropylene resin, a foamed product of an acrylic resin, or the like can be used.
The moisture barrier layer 115 preferably has pressure sensitive adhesive properties. Such a moisture barrier layer having pressure-sensitive adhesiveness preferably includes a rubber-based resin layer (rubber-based pressure-sensitive adhesive layer), and more preferably includes a polyisobutylene-based resin layer (polyisobutylene-based pressure-sensitive adhesive layer).
The polyisobutylene-based resin layer is formed from a polyisobutylene-based composition. The polyisobutylene composition contains polyisobutylene as a rubber component. The content of polyisobutylene in the polyisobutylene-based composition is preferably 10 to 50% by mass, and more preferably 20 to 40% by mass, for example.
The polyisobutylene composition preferably contains a high water absorbent resin and a binder. Thus, a rubber composition such as a polyisobutylene composition can have excellent moisture barrier properties and pressure-sensitive adhesive properties.
Examples of the super absorbent resin include anhydrous maleate-based resins (for example, sodium salt crosslinked product of isobutylene/anhydrous maleic acid copolymer), polyacrylate-based resins, polysulfone-based resins, polyacrylamide-based resins, polyvinyl alcohol-based resins, and the like, and preferably include anhydrous maleate-based resins. The content of the super absorbent resin is, for example, 1 to 10 parts by mass, and more preferably 3 to 5 parts by mass, based on 100 parts by mass of the polyisobutylene.
Examples of the tackifier include rosin-based resins, terpene-based resins (e.g., terpene-aromatic liquid resins), benzofuran-indene-based resins, phenol-formalin-based resins, xylene formaldehyde-based resins, petroleum-based resins (e.g., C5-based petroleum resins, C9-based petroleum resins, C5/C9-based petroleum resins, etc.), and preferably include petroleum-based resins. The content of the tackifier is preferably 10 to 200 parts by mass, and more preferably 50 to 150 parts by mass, based on 100 parts by mass of polyisobutylene.
The polyisobutylene-based composition may further contain a softener, a filler, a crosslinking agent, and the like as necessary.
Examples of the softening agent include oils such as liquid rubbers, e.g., polybutene, liquid isoprene rubber, and liquid butadiene rubber, paraffin oil, and naphthene oil; esters such as phthalic acid esters and phosphoric acid esters are preferably used as the liquid rubber. The content of the softener is preferably 10 to 200 parts by mass, more preferably 50 to 150 parts by mass, based on 100 parts by mass of polyisobutylene.
Examples of the filler include ground calcium carbonate, light calcium carbonate, and calcium carbonate such as white brilliant calcium carbonate; carbon black, talc, mica, clay, mica powder, bentonite, silica, alumina, aluminum silicate, titanium oxide, glass powder, boron nitride powder; metal powders such as aluminum powder and iron powder; resin powders such as acrylic resin powder and styrene resin powder; and metal hydroxides such as aluminum hydroxide and magnesium hydroxide, preferably calcium carbonate. The content of the filler is preferably 10 to 200 parts by mass, more preferably 50 to 150 parts by mass, based on 100 parts by mass of polyisobutylene.
Examples of the crosslinking agent include isocyanate compounds such as hexamethylene diisocyanate. The content of the crosslinking agent is preferably 1 to 10 parts by mass, more preferably 3 to 5 parts by mass, based on 100 parts by mass of polyisobutylene, for example.
The polyisobutylene composition may contain known additives such as a blowing agent and a plasticizer at an arbitrary ratio.
From the viewpoint of stability of fixation to the skin, the rubber-based resin layer preferably includes a styrene-butadiene rubber (SBR) -based resin layer and a natural rubber/SBR-based resin layer, and more preferably includes an SBR-based resin layer.
The SBR-based resin layer is formed of an SBR-based composition. SBR-based compositions are referred to as rubber-containing SBR. The content of SBR in the SBR-based composition is preferably 10 to 50% by mass, more preferably 20 to 40% by mass.
The SBR-based composition may contain a super absorbent resin, a thickener, a softener, a filler, a crosslinking agent, and the like, as in the polyisobutylene-based composition.
The natural rubber/SBR-based resin layer is formed of a natural rubber/SBR-based composition. The natural rubber/SBR-based composition contains natural rubber and SBR as rubber components. The total content of the natural rubber and the SBR in the natural rubber/SBR-based composition is preferably 10 to 50% by mass, more preferably 20 to 40% by mass.
The natural rubber/SBR-based composition may contain a super absorbent resin, a thickener, a softener, a filler, a crosslinking agent, and the like, as in the polyisobutylene-based composition.
The thickness of the moisture blocking layer 115 is approximately the same as that of the pressure-sensitive adhesive layer 110. Specifically, the thickness of the moisture barrier layer 115 is preferably 10 to 300. mu.m, more preferably 20 to 100. mu.m, and still more preferably 30 to 50 μm.
(modification example)
In the present embodiment, the electrode 10 may not have the hole 13 in the main surface 11.
In the present embodiment, the number of the holes 13 may be set to an optimum number, as appropriate, depending on the size of the electrode 10, and the like, and may be one or more.
As shown in fig. 7, in the present embodiment, the electrode 10 may have a plurality of concave portions 14 recessed from the principal surface 11 to the principal surface 12 in addition to the hole 13. This can increase the contact area between the main surface 12 of the electrode 10 and the skin 200, and thus the electrode 10 and the skin 200 can more stably secure electrical conductivity.
In the present embodiment, the arrangement of the holes 13 is not limited to the square lattice shape, and may be a rhombic lattice shape or a hexagonal lattice shape (staggered shape). In addition, the plurality of holes 13 may be arranged regularly or irregularly.
In the present embodiment, the shape of the hole 13 may be a polygon such as a rectangle in a plan view. For example, as shown in fig. 8, the hole 13 may be formed in a rectangular shape in a plan view. The rectangle may be square or rectangular. In this case, the length L of each side of the hole 13 is preferably 100nm to 10mm, more preferably 300nm to 5mm, and still more preferably 600 μm to 2 mm. When the shape of the hole 13 is rectangular, the longer side is preferably the above value.
In the present embodiment, the shape and size of each hole 13 may not be uniform.
In the present embodiment, the through- holes 113 and 123 of the adhesive biosensor 100 are formed in a rectangular shape in a plan view, but may be formed in other shapes such as a circular shape.
In the present embodiment, the attachment type biosensor 100 may not have the electronic device 150, the battery 160, or the case 170.
In the present embodiment, the adhesive biosensor 100 may be provided with a release sheet made of a resin such as polyethylene terephthalate on the lower surfaces of the pressure-sensitive adhesive layer 110, the pressure-sensitive adhesive layer 110A, and the probe 140.
(examples)
The embodiments will be described in more detail below by way of examples and comparative examples, but the embodiments are not limited to these examples and comparative examples.
< example 1>
[ example 1-1]
(preparation of conductive composition)
38.0 parts by mass of an aqueous solution containing PEDOT/PSS (PEDOT/PSS concentration: 1%, "Clevious PH 1000", manufactured by Helrich) as a conductive polymer, 10.0 parts by mass of an aqueous solution containing modified polyvinyl alcohol (modified polyvinyl alcohol concentration: 10%, "G0 HSENX Z-410", manufactured by Nippon synthetic Chemicals Co., Ltd.) as a binder resin, 2.0 parts by mass of an aqueous solution containing a zirconium compound (zirconium compound concentration: 10%, "SAFELINK SPM-01", manufactured by Nippon synthetic Chemicals Co., Ltd.) as a crosslinking agent, 2.0 parts by mass of glycerin (manufactured by Wako pure chemical Co., Ltd.) as a plasticizer, and 0.08 parts by mass of a silicone surfactant ("SILFACE SAG 002", manufactured by Nissan chemical industry ") as a surfactant were added to the ultrasonic bath. Then, an aqueous solution containing these components was mixed in an ultrasonic bath for 30 minutes to prepare a uniform aqueous solution of the conductive composition.
Since the concentration of PEDOT/PSS in the aqueous solution containing PEDOT/PSS was about 1%, the content of PEDOT/PSS in the aqueous solution of the conductive composition became 0.38 parts by mass. Since the concentration of the modified polyvinyl alcohol in the aqueous solution containing the modified polyvinyl alcohol was about 10%, the content of the modified polyvinyl alcohol in the aqueous solution of the conductive composition was 1.00 part by mass. Since the concentration of the zirconium-based compound in the aqueous solution containing the zirconium-based compound is about 10%, the content of the zirconium-based compound in the aqueous solution of the conductive composition is 0.20 parts by mass. The remainder is a solvent in the aqueous solution of the conductive composition.
The contents of the conductive polymer, the binder resin, the crosslinking agent, the plasticizer, and the surfactant were 10.4 parts by mass, 27.3 parts by mass, 5.5 parts by mass, 54.6 parts by mass, and 2.2 parts by mass, respectively, with respect to 100 parts by mass of the conductive composition.
(preparation of electrode)
The aqueous solution of the conductive composition thus prepared was applied onto a PET film (3 cm. times.3 cm), and then the aqueous solution of the conductive composition was dried by heating at 120 ℃ for 10 minutes to prepare a cured product of the conductive composition (1 cm. times.1 cm in length, 10 μm in thickness). Then, the cured product was pressed with a press while being closely adhered to a release sheet (PET film). Thus, a probe sheet was produced which had a plurality of circular holes on the release sheet and electrodes (pore diameter: 300 μm, open pore ratio: 30%) arranged in a square lattice pattern on the main surface.
(evaluation of peeling difficulty)
In order to evaluate the difficulty of peeling off the electrode, a moisture barrier layer and an adherend to be attached to the electrode were prepared.
(1) Preparation of moisture barrier
An SBR-based resin (product "SLY-25", manufactured by ritonan electric corporation) was diluted with a toluene solvent so that the ratio of the SBR-based resin to the toluene solvent was 10:1 to prepare a mixed solution. The mixed solution was applied to the surface of a second release sheet (PET film), and the sheet was dried by heating. Thereby, a moisture barrier sheet having pressure-sensitive adhesiveness was obtained. The moisture barrier layer was formed in a substantially rectangular shape (1 cm. times.1 cm, thickness 25 μm) in plan view.
(2) Preparation of adherend
A pretreatment of naturally thawing a pigskin (Yucatan micropig: YMP "skin set, manufactured by Charles River, Japan) cryopreserved at-80 ℃ and removing subcutaneous fat was performed. Thereafter, the pretreated pigskin was cut into 30mm × 50mm × 5 mm. The cut pigskin was used as an adherend.
(3) Measurement of peeling adhesion
On one main surface of the fabricated electrode, the fabricated moisture barrier layer was formed as described above, thereby fabricating an experimental body. Then, the exposed main surface of the electrode of the test piece was attached to the prepared adherend as described above, and pressure-bonded by making a 2kg roller go and go once. Thereafter, the test body was kept at 23 ℃ for 5 minutes in a standard atmosphere of 50% RH. Then, in this standard environment, 180 DEG peel adhesion (unit: N/10mm) of the test body to the adherend was measured by performing a 180 DEG peel test of the test body under conditions of a peel angle of 180 DEG and a tensile speed of 100 mm/min using a bench top precision Universal testing machine ("Autograph AGS-50 NX", manufactured by Shimadzu corporation). The measurement was performed three times (N is 3), and the average value of the measured values was set as the peel adhesion (initial peel strength). The measurement results are shown in fig. 9. Further, the peel adhesion force at room temperature obtained by the above experiment was 0.010mN/10mm or more, and the evaluation was good (shown as a in table 1). When the peel adhesion was less than 0.010N/10mm or more than 0.8N/10mm, the evaluation was poor (shown as B in Table 1). The measurement results and evaluation results of peel adhesion are shown in table 1.
[ examples 1-2]
The procedure of example 1-1 was repeated, except that the spacing between the holes of the electrode was changed to 600 μm and the opening ratio was changed to 14.9% in example 1-1.
[ examples 1 to 3]
The same procedure as in example 1-1 was repeated, except that the interval between the pores of the electrode was changed to 900 μm and the open porosity was changed to 8.1% in example 1-1.
[ examples 1 to 4]
The procedure of example 1-1 was repeated, except that the pore diameter of the electrode was changed to 600 μm and the opening ratio was changed to 46.8% in example 1-1.
[ examples 1 to 5]
The procedure of example 1-1 was repeated, except that the pore diameter of the electrode was changed to 900 μm and the opening ratio was changed to 55.9% in example 1-1.
[ examples 1 to 6]
The procedure of example 1-1 was repeated, except that the pore diameter of the electrode was changed to 1200 μm and the opening ratio was changed to 53.9% in example 1-1.
[ examples 1 to 7]
The procedure of example 1-1 was repeated, except that the hole interval between the electrodes was changed to 1200 μm and the opening ratio was changed to 6.1% in example 1-1.
Comparative examples 1 to 1
The procedure of example 1-1 was repeated, except that the hole interval between the electrodes was changed to 2000. mu.m in example 1-1, and the opening ratio was changed to 1.2%.
Table 1 shows the shapes of the pores, the pore diameters, the intervals between pores, the opening ratios, and the peeling adhesion of the electrodes of the examples and comparative examples.
(Table 1)
As shown in FIG. 9 and Table 1, in examples 1-1 to 1-7, the opening ratio was 6.1% or more, and the peel adhesion was 0.012N/10mm or more. On the other hand, in comparative example 1-1, the aperture ratio was 1.2%, and the peel adhesion was 0.000N/10 mm.
From this, it was confirmed that when the opening ratio of the electrode was 6% to 56%, the peel adhesion force was 0.012N/10mm or more, and high adhesiveness was obtained. Therefore, in the biosensor according to one embodiment, since the electrode has an aperture ratio in a predetermined range, the electrode can have stable adhesive force and conductivity when used as an electrode of the biosensor. Therefore, it can be said that the biosensor can be effectively used for measuring a cardiogram for a long time (for example, 24 hours) by closely adhering the biosensor to the skin of a subject.
< example 2>
[ example 2-1]
(preparation of electrode)
The electrode produced in example 1-1 was used. The number of holes per unit area of the electrode was 261 holes/cm2。
(evaluation of peeling difficulty)
The peel adhesion was measured and evaluated in the same manner as in example 1-1. The measurement results are shown in fig. 10. Further, the peel adhesion at ordinary temperature obtained by the above experiment was evaluated in the same manner as in example 1-1. The results of measurement and evaluation of peel adhesion are shown in table 2.
(evaluation of the elongation at Break)
The expansion and contraction rate at break when the test piece was subjected to a 180 ° peel test was measured. Fig. 11 shows the measurement results of the expansion and contraction rate at break. Table 2 shows the measurement results and evaluation results of the expansion and contraction rate at break.
[ examples 2-2]
Except that the aperture diameter of the electrode and the interval between the holes were changed to 600 μm in example 2-1, and the number of holes per unit area of the electrode was changed to 61 holes/cm2Otherwise, the same procedure as in example 2-1 was repeatedAnd (6) rows.
[ examples 2 to 3]
Except that in example 2-1, the aperture diameter of the electrode and the interval between the holes were changed to 900 μm, and the number of holes per unit area of the electrode was changed to 26 holes/cm2Otherwise, the procedure was carried out in the same manner as in example 2-1.
[ examples 2 to 4]
Except that in example 2-1, the aperture diameter of the electrode and the interval between the holes were changed to 1200 μm, and the number of holes per unit area of the electrode was changed to 14 holes/cm2Otherwise, the procedure was carried out in the same manner as in example 2-1.
Comparative example 2-1
Except that in example 2-1, the aperture diameter of the electrode and the interval between the holes were changed to 100 μm, and the number of holes per unit area of the electrode was changed to 2500 holes/cm2Otherwise, the procedure was carried out in the same manner as in example 2-1.
Table 2 shows the shape of the pores, the pore diameter, the interval between pores, the number of pores per unit area, the peeling adhesion, and the expansion and contraction rate at break of the electrodes of the examples and comparative examples.
(Table 2)
As shown in FIG. 10 and Table 2, in examples 2-1 to 2-4, the number of holes per unit area was 14 or more, and the peel adhesion was 0.082N/10mm or more. On the other hand, as shown in Table 2, in comparative example 2-1, the number of holes per unit area was 2500/cm2The peel adhesion was 0.000N/10 mm.
As shown in FIG. 11 and Table 2, in examples 2-1 to 2-4, even when the peel adhesion was 0.082N/10mm or more, the elongation at break was 5% or more.
From this, it was confirmed that when the number of holes per unit area of the electrode was 261 or less, the electrode could have a peel adhesion force of 0.082N/10mm or more, and could have high adhesion. In addition, it was confirmed that the electrode can have a stretching ratio at the time of fracture of 5% or more.
Therefore, the number of holes per unit area of the electrode is equal to or less than a predetermined value, and the expansion and contraction rate at the time of fracture is also equal to or more than a predetermined value, so that when the electrode is used as a probe for a biosensor, the adhesion layer provided on one surface of the probe can be prevented from peeling off from the biological surface on which the probe is provided, and the electrode can have conductivity. Thus, since the biosensor can stably have adhesive force and conductivity, it can be said that the biosensor can be effectively used for continuously measuring a electrocardiogram for a long time (for example, 24 hours) by closely adhering the biosensor to the skin of a subject.
As described above, the embodiments have been described, but the embodiments are merely examples, and the present invention is not limited thereto. The above embodiments may be implemented in other various ways, and various combinations, omissions, substitutions, and changes may be made without departing from the spirit of the invention. These embodiments and modifications thereof are included in the scope and gist of the invention, and are included in the invention described in the claims and the equivalent scope thereof.
The invention claims that the entire contents of Japanese patent application No. 2019-.
Description of the reference numerals
10 electrode
11. 12 major surface
13. 140A hole
100 sticking type biosensor (biosensor)
110 pressure sensitive adhesive layer
120 base material layer
130 circuit part
140 probe
141 connecting surface
150 electronic device
160 cell
170 casing
Claims (7)
1. A biosensor, having:
a pressure sensitive adhesive layer for attachment to a biological surface;
an electrode disposed on a biological surface-facing adhesion side of the pressure-sensitive adhesive layer so as to be contactable with the biological surface;
an electronic device for processing the biological signal obtained by the electrode; and
a circuit unit for connecting the electrode and the electronic device,
the electrode has a connection surface connected to the circuit portion on a side of attachment to the biological surface.
2. The biosensor of claim 1,
the electrode is formed in a plate shape having a pair of main surfaces parallel to each other, and has one or more holes penetrating through the connection surface in a thickness direction of the electrode,
the circuit unit is connected to the electrode on the opposite side of the biological surface to the side to which the biological surface is attached.
3. The biosensor of claim 1 or 2,
the electrode is a plate-shaped electrode including a conductive polymer and a binder resin and having a pair of main surfaces parallel to each other,
the electrode has a plurality of holes penetrating in a thickness direction thereof,
the aperture ratio of the pores in the main surface is 2% to 80%.
4. The biosensor of claim 2 or 3,
the number of the holes is 2000/cm2The following.
5. The biosensor of any one of claims 2 to 4,
the plurality of holes are arranged in a square lattice shape, a rhombic lattice shape, or a hexagonal lattice shape on the main surface.
6. The biosensor of any one of claims 2 to 5,
the hole is vertically penetrated with respect to the main surface.
7. The biosensor of any one of claims 2 to 6,
at least one of the pair of main surfaces includes a recess.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2019-042984 | 2019-03-08 | ||
| JP2019042984 | 2019-03-08 | ||
| JP2020-030104 | 2020-02-26 | ||
| JP2020030104A JP6814899B2 (en) | 2019-03-08 | 2020-02-26 | Biosensor |
| PCT/JP2020/009239 WO2020184346A1 (en) | 2019-03-08 | 2020-03-04 | Biosensor |
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| Publication Number | Publication Date |
|---|---|
| CN113597284A true CN113597284A (en) | 2021-11-02 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202080018415.5A Pending CN113597284A (en) | 2019-03-08 | 2020-03-04 | Biosensor and method for measuring the same |
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| CN (1) | CN113597284A (en) |
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|---|---|---|---|---|
| WO2021200859A1 (en) * | 2020-03-30 | 2021-10-07 | 日東電工株式会社 | Electrode and biosensor using same |
| WO2024024694A1 (en) * | 2022-07-26 | 2024-02-01 | 日東電工株式会社 | Biological adhesive and biosensor |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2014237059A (en) * | 2014-09-25 | 2014-12-18 | 日本電信電話株式会社 | Bioelectrode and biosignal measurement device |
| JP2018102404A (en) * | 2016-12-22 | 2018-07-05 | グンゼ株式会社 | Bioelectrode |
| WO2018198571A1 (en) * | 2017-04-28 | 2018-11-01 | 日東電工株式会社 | Laminate for biosensor and method for producing laminate for biosensor |
| JP2018186958A (en) * | 2017-04-28 | 2018-11-29 | 日東電工株式会社 | Sheet for biological sensor |
| TW201841590A (en) * | 2017-04-28 | 2018-12-01 | 日商日東電工股份有限公司 | Biosensor |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030069510A1 (en) * | 2001-10-04 | 2003-04-10 | Semler Herbert J. | Disposable vital signs monitor |
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- 2020-03-04 CN CN202080018415.5A patent/CN113597284A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2014237059A (en) * | 2014-09-25 | 2014-12-18 | 日本電信電話株式会社 | Bioelectrode and biosignal measurement device |
| JP2018102404A (en) * | 2016-12-22 | 2018-07-05 | グンゼ株式会社 | Bioelectrode |
| WO2018198571A1 (en) * | 2017-04-28 | 2018-11-01 | 日東電工株式会社 | Laminate for biosensor and method for producing laminate for biosensor |
| JP2018186958A (en) * | 2017-04-28 | 2018-11-29 | 日東電工株式会社 | Sheet for biological sensor |
| TW201841590A (en) * | 2017-04-28 | 2018-12-01 | 日商日東電工股份有限公司 | Biosensor |
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| JP6814899B2 (en) | 2021-01-20 |
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