JP2020151104A - Sticking type biological sensor - Google Patents

Abstract

To provide a sticking type biological sensor in which a biological signal for testing can be easily input after completion.SOLUTION: A sticking type biological sensor includes: a pressure-sensitive adhesive layer having a sticking surface to be stuck onto a subject; an electrode; a base material layer provided superposed on an opposite surface of the sticking surface of the pressure-sensitive adhesive layer; an electronic device provided on the base material layer for processing a biological signal acquired through the electrode; a battery provided on the base material layer for supplying power to the electronic device; a circuit part provided on the base material layer for connecting the electrode and the electronic device; a cover provided on the base material layer for covering the electronic device, the battery, and the circuit part; and a pad connected to the circuit part or the electrode.SELECTED DRAWING: Figure 1

Description

The present invention relates to a stick-on biosensor.

Conventionally, there is a biosensor using a biocompatible polymer substrate including a plate-shaped first polymer layer, a plate-shaped second polymer layer, an electrode, and a data acquisition module (see, for example, Patent Document 1). ).

Japanese Unexamined Patent Publication No. 2012-010978

By the way, when a biological sensor is used for medical purposes, a test is performed after completion according to an industrial standard or the like, and for example, the attenuation rate of the biological signal extracted from the biological sensor is measured with respect to the biological signal input to the biological sensor. In some cases.

In such a case, the electrode included in the biological sensor may be a mesh-shaped electrode exposed from the sticking surface of the adhesive layer to be stuck to the skin of the living body, or may be composed of a plurality of conductive parts exposed from the sticking surface. In the case of an electrode to be used, if the terminal of the test device is brought into contact with the electrode in order to input a biological signal to the biosensor, the adhesive layer sticks to the terminal and it becomes difficult to return to the original state.

Further, when the terminal of the test device is brought into contact with only a part of the mesh-shaped electrode or only a part of a plurality of electrode parts and a biological signal is input to the biosensor, the test device is applied to the entire mesh electrode or a plurality of electrode parts. Since the resistance value is higher than when the terminal of the above is brought into contact with the electrode, it becomes difficult to measure correctly.

As described above, when the biosensor includes the mesh-shaped electrode as described above or the electrode composed of a plurality of conductive portions, it is difficult to input the biological signal to the biosensor for testing.

Therefore, it is an object of the present invention to provide a stick-on biosensor capable of easily inputting a biological signal for testing after completion.

The stick-on biosensor according to the embodiment of the present invention is a base material provided so as to be overlapped with a pressure-sensitive adhesive layer having a sticking surface to be stuck to a subject, an electrode, and an opposite surface of the sticking surface of the pressure-sensitive adhesive layer. A layer, an electronic device provided on the base material layer for processing a biological signal acquired via the electrode, a battery provided on the base material layer for supplying power to the electronic device, and the base. A circuit unit provided on the material layer and connecting the electrode and the electronic device, a cover provided on the base material layer and covering the electronic device, the battery, and the circuit unit, and the circuit unit or the circuit unit. Includes pads connected to electrodes.

It is possible to provide a stick-on biosensor capable of easily inputting a biological signal for testing after completion.

It is a perspective view which shows the sticking type biosensor 100 of embodiment. It is a top view which shows the sensor device 100A of embodiment. It is a figure which shows the cross section of AA of FIG. It is a figure which shows the part of FIG. 3 enlarged. It is an exploded view which shows the sticking type biosensor 100M1 of the 1st modification of embodiment. It is a figure which shows the cross section of the completed state corresponding to CC arrow view of FIG. It is a figure which shows the stick-on type biosensor 100. It is a figure which shows the stick-on type biosensor 100. It is a figure which shows the probe 140M of the modification of the embodiment. It is a figure which shows the sticking type biosensor 100M3 of the 3rd modification of embodiment. It is sectional drawing which shows the state which the terminal 500 of the test apparatus is connected to the test terminal 180 of the sticking type biosensor 100M3. It is a figure which shows the sticking type biosensor 100M4 of the 4th modification of embodiment. It is a figure which shows the sticking type biosensor 100M5 of the 5th modification of embodiment. It is sectional drawing which shows the state which the terminal 500M5 of a test apparatus is connected to the test terminal 180M3 of the sticking type biosensor 100M5.

Hereinafter, embodiments to which the stick-on biosensor of the present invention is applied will be described.

<Embodiment>
FIG. 1 is a perspective view showing the stick-on biosensor 100 of the embodiment. The stick-on biosensor 100 includes, as main components, a pressure-sensitive adhesive layer 110, a base material layer 120, a circuit unit 130, a probe 140, an electronic device 150, a battery 160, a cover 170, and a test terminal 180.

FIG. 2 is a plan view showing the sensor device 100A of the embodiment. The sensor device 100A is a stick-on biosensor 100 from which the cover 170 has been removed.

FIG. 3 is a diagram showing a cross section taken along the line AA of FIG. The cross section of the portion excluding the cover 170 from the cross section shown in FIG. 3 corresponds to the cross section seen by the arrow BB in FIG. FIG. 4 is an enlarged view of a part of FIG.

In the following, the XYZ coordinate system will be defined and described. In the following, for convenience of explanation, the negative side of the Z axis is referred to as the lower side or the lower side, and the positive side of the Z axis is referred to as the upper side or the upper side, but does not represent a universal hierarchical relationship.

In the present embodiment, as an example, a stick-on biosensor 100 that is brought into contact with a living body as a subject to measure biological information will be described. The living body means a human body and an organism other than the human body, and is attached to the skin, scalp, forehead, or the like. Hereinafter, each member constituting the stick-on biosensor 100 will be described.

Hereinafter, a mode in which the probe 140 is used as an example of an electrode that comes into contact with a living body as a subject will be described.

The stick-on biosensor 100 is a sheet-like member having a substantially elliptical shape in a plan view. The upper surface 111 (the surface on the + Z direction side) of the stick-on biosensor 100 is covered with the cover 170. The lower surface of the stick-on biosensor 100 is a stick-on surface.

The circuit unit 130, the electronic device 150, and the battery 160 are mounted on the upper surface of the base material layer 120. Further, the probe 140 is provided so as to be embedded in the pressure-sensitive adhesive layer 110 so as to be exposed from the lower surface 112 of the pressure-sensitive adhesive layer 110. The lower surface 112 is a sticking surface of the sticking type biosensor 100.

The pressure-sensitive adhesive layer 110 and the base material layer 120 are laminated, and the laminate of the pressure-sensitive adhesive layer 110 and the base material layer 120 is covered with a cover 170 except for the lower surface 112.

The pressure-sensitive adhesive layer 110 is a flat-plate adhesive layer. The pressure-sensitive adhesive layer 110 extends along the longitudinal direction (X-axis direction), and the central portion 115 in the longitudinal direction (X-axis direction) is shorter than the end portions 110B at both ends in the longitudinal direction (X-axis direction). It overhangs outward in the direction (Y-axis direction).

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 in which the stick-on biosensor 100 comes into contact with the living body. Since the lower surface 112 has pressure-sensitive adhesiveness, it can be attached to the skin 10 of a living body. The lower surface 112 is the lower surface of the stickable biological sensor 100, and can be attached to the surface of the living body such as the skin 10.

The pressure-sensitive adhesive layer 110 has a groove portion 112A provided on the lower surface 112. The groove portion 112A is formed in a mesh shape in a rectangular region in a plan view, and the probe 140 is housed in the groove portion 112A.

The pressure-sensitive adhesive layer 110 has a through hole 113 that penetrates the pressure-sensitive adhesive layer 110 in the thickness direction (Z direction). The through hole 113 communicates with the through hole 123 provided in the base material layer 120, and the probe support 200 is housed inside the through hole 113 and the through hole 123.

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 and a silicone-based pressure-sensitive adhesive. Acrylic pressure-sensitive adhesives are preferable.

The acrylic pressure-sensitive adhesive contains an acrylic polymer as a main component.

Acrylic polymer is a pressure sensitive adhesive component. The acrylic polymer contains a (meth) acrylic acid ester such as isononyl acrylate and methoxyethyl acrylate as a main component, and a monomer component copolymerizing with a (meth) acrylic acid ester such as acrylic acid as an optional component. A polymer obtained by polymerizing the above can be used. The content of the main component in the monomer component is 70% by mass to 99% by mass, and the content of the optional component in the monomer component is 1% by mass to 30% by mass. As the acrylic polymer, for example, the (meth) acrylic acid ester-based polymer described in JP-A-2003-342541 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 is a pressure-sensitive adhesive force adjusting agent that reduces the pressure-sensitive adhesive force of the acrylic polymer and adjusts the pressure-sensitive adhesive force of the pressure-sensitive adhesive layer 110. The carboxylic acid ester is a carboxylic acid ester compatible with an acrylic polymer.

Specifically, the carboxylic acid ester is, for example, the trifatty acid glyceryl.

The content ratio of the carboxylic acid ester is preferably 30 parts by mass to 100 parts by mass, and more preferably 50 parts by mass to 70 parts by mass or less with respect to 100 parts by mass of the acrylic polymer.

The acrylic pressure-sensitive adhesive may contain a cross-linking agent, if necessary. The cross-linking agent is a cross-linking component that cross-links the acrylic polymer. Examples of the cross-linking agent include polyisocyanate compounds, epoxy compounds, melamine compounds, peroxide compounds, urea compounds, metal alkoxide compounds, metal chelate compounds, metal salt compounds, carbodiimide compounds, oxazoline compounds, aziridine compounds, amine compounds and the like. .. These cross-linking agents may be used alone or in combination. The cross-linking agent is preferably a polyisocyanate compound (polyfunctional isocyanate compound).

The content of the cross-linking agent is preferably, for example, 0.001 part by mass to 10 parts by mass, and more preferably 0.01 part by mass to 1 part by mass with respect to 100 parts by mass of the acrylic polymer.

The pressure-sensitive adhesive layer 110 preferably has excellent biocompatibility. For example, when the pressure-sensitive adhesive layer 110 is subjected to a keratin peeling test, the keratin peeling area ratio is preferably 0% to 50%, more preferably 1% to 15%. When the keratin exfoliation area ratio is in the range of 0% to 50%, the load on the skin 10 (see FIG. 2) can be suppressed even if the pressure-sensitive adhesive layer 110 is attached to the skin 10 (see FIG. 2). The keratin exfoliation test is measured by the method described in JP-A-2004-83425.

The moisture permeability of the pressure-sensitive adhesive layer 110 is preferably 300 (g / M4 / day) or more, more preferably 600 (g / M4 / day) or more, and 1000 (g / M4 / day) or more. Is more preferable. If the moisture permeability of the pressure-sensitive adhesive layer 110 is 300 (g / M4 / day) or more, even if the pressure-sensitive adhesive layer 110 is attached to the skin 10 of a living body (see FIG. 2), the skin 10 (see FIG. 2). ) Load can be suppressed.

The pressure-sensitive adhesive layer 110 satisfies at least one of the requirements that the keratin peeling area ratio in the keratin peeling test is 50% or less and the moisture permeability is 300 (g / M4 / day) or more. , The pressure-sensitive adhesive layer 110 has biocompatibility. It is more preferable that the material of the pressure-sensitive adhesive layer 110 satisfies both of the above requirements. As a result, the pressure-sensitive adhesive layer 110 is more stable and has high biocompatibility.

The thickness of the pressure-sensitive adhesive layer 110 is preferably such that the distance between the upper surface 111 and the lower surface 112 in the region other than the groove 112A is 10 μm to 300 μm. When the thickness of the pressure-sensitive adhesive layer 110 is 10 μm to 95 μm, the stick-on biosensor 100 can be made thinner, and in particular, the area other than the electronic device 150 in the stick-on biosensor 100 can be made thinner. The distance between the upper surface 111 and the lower surface 112 in the region other than the groove portion 112A is more preferably 20 μm to 100 μm, and further preferably 30 μm to 50 μm.

The base material layer 120 is a support layer that supports the pressure-sensitive adhesive layer 110, and the pressure-sensitive adhesive layer 110 is adhered to the lower surface of the base material layer 120. A circuit unit 130 is embedded in the upper surface side of the base material layer 120, and an electronic device 150 and a battery 160 are mounted on the upper surface side.

The base material layer 120 is a flat plate-shaped (sheet-shaped) member made of an insulator, and is provided on the upper surface of the pressure-sensitive adhesive layer 110 as shown in FIG. As shown in FIG. 2, the shape of the base material layer 120 in a plan view is the same as the shape of the pressure-sensitive adhesive layer 110 in a plan view, and they are aligned and overlapped in a plan view.

As shown in FIG. 3, the base material layer 120 has a lower surface 121 and an upper surface 122. The lower surface 121 and the upper surface 122 are flat surfaces. The lower surface 121 is in contact with the upper surface 111 of the pressure-sensitive adhesive layer 110 (pressure-sensitive adhesion). The upper surface 122 of the base material layer 120 is an example of a mounting surface.

The base material layer 120 has a groove portion 122A provided on the upper surface 122 and a through hole 123 provided at the same position as the through hole 113 of the pressure-sensitive adhesive layer 110 in a plan view and having an opening size equal to that of the through hole 113. The probe support 200 is housed in the through holes 113 and 123.

The thickness of the base material layer 120 is preferably 1 μm to 300 μm, more preferably 5 μm to 100 μm, and even more preferably 10 μm to 50 μm.

The base material layer 120 is formed from the base material composition. The base material composition contains a base material resin as a main component. The base material layer 120 has adhesiveness (tack).

As the base resin, for example, a flexible resin capable of imparting appropriate elasticity, flexibility and toughness to the base layer 120 is used. Examples of the base resin include thermoplastic resins such as polyurethane-based resins, silicone-based resins, acrylic-based resins, polystyrene-based resins, vinyl chloride-based resins, and polyester resin-based resins. From the viewpoint of ensuring that the base material layer 120 has more excellent elasticity, it is preferable to use a polyurethane resin.

The probe support 200 is housed in a pressure-sensitive adhesive layer 110A similar to the pressure-sensitive adhesive layer 110, a base material layer 120A similar to the base material layer 120, and a groove 112A provided on the lower surface of the pressure-sensitive adhesive layer 110A. It has a probe 140 and a connecting portion 210 provided on the side surface of the pressure-sensitive adhesive layer 110A and the base material layer 120A.

The laminate of the pressure-sensitive adhesive layer 110A and the base material layer 120A is columnar, and the connecting portion 210 is a cylindrical member and has a through hole 210A. The connecting portion 210 is made of a conductive member, and a laminate of the pressure-sensitive adhesive layer 110A and the base material layer 120A is fitted inside the through hole 210A. In this state, the lower end of the side surface of the connecting portion 210 is connected to the probe 140, and the upper end of the side surface of the connecting portion 210 is connected to the wiring 131. By using such a connecting portion 210, the wiring 131 and the probe 140 can be connected.

The circuit unit 130 has a wiring 131. As shown in FIGS. 3 and 4, the wiring 131 is provided inside the groove portion 122A of the upper surface 122 of the base material layer 120A. As shown in FIG. 2, the wiring 131 is patterned in a T shape in a plan view, and is provided one on the + X direction side and one on the −X direction side. The wiring 131 has a terminal 131A connected to the terminal 151 of the electronic device 150 and a terminal 131B connected to the terminal of the battery 160, and the remaining one end (the end on the + X direction side and the end on the −X direction side). Section) is connected to the connection section 210.

As a material for forming the wiring 131, copper, nickel, gold, an alloy thereof, or the like can be used. Copper is preferable as the material of the wiring 131.

The thickness of the wiring 131 is preferably designed to be thinner than the thickness of the base material layer 120. The thickness of the wiring 131 is preferably 0.1 μm to 100 μm, more preferably 1 μm to 50 μm, and even more preferably 5 μm to 30 μm.

The probe 140 is an electrode that comes into contact with a subject, and specifically, is an electrode that comes into contact with the skin 10 and detects a biological signal when the pressure-sensitive adhesive layer 110 is attached to the skin 10. The biological signal is, for example, an electric signal representing an electrocardiographic waveform, an electroencephalogram, a pulse, or the like.

The electrode used as the probe 140 is manufactured by using a conductive composition containing at least a conductive polymer and a binder resin as described later. Further, the electrode is manufactured by punching a sheet-shaped member obtained by using the conductive composition with a mold or the like, and is used as a probe.

As shown in FIG. 4, the probe 140 is formed in a grid shape (mesh shape) in a plan view, and has holes 140A arranged in a matrix shape. At the ends (parts of the four ends) of the probe 140 in the X and Y directions, the ladder-shaped sides of the probe 140 may protrude. The electrode used as the probe 140 may have a predetermined pattern shape. Examples of the predetermined electrode pattern shape include a mesh shape, a stripe shape, and a shape in which a plurality of electrodes are exposed from the sticking surface. As an example, 25 holes 140A are provided in 5 rows × 5 columns. The hole 140A is filled with the pressure-sensitive adhesive layer 110.

As shown in FIGS. 3 and 4, the probe 140 is arranged on the lower surface 112 of the pressure-sensitive adhesive layer 110, and is embedded in the pressure-sensitive adhesive layer 110 so as to be exposed from the lower surface 112 of the pressure-sensitive adhesive layer 110. ing. The probe 140 is embedded in the groove portion 112A of the pressure-sensitive adhesive layer 110, and is arranged on the lower surface 112 forming the groove portion 112A. The lower surface of the probe 140 is flush with the lower surface 112 of the pressure-sensitive adhesive layer 110.

The thickness of the probe 140 is preferably thinner than the thickness of the pressure-sensitive adhesive layer 110. The thickness of the probe 140 is preferably 0.1 μm to 100 μm, more preferably 1 μm to 50 μm.

The electrode used as the probe 140 is preferably manufactured by thermosetting the following conductive composition and molding it. The conductive composition contains a conductive polymer, a binder resin, and at least one of a cross-linking agent and a plasticizer.

As the conductive polymer, for example, polythiophene, polyacetylene, polypyrrole, polyaniline, polyphenylene vinylene and the like can be used. These may be used alone or in combination of two or more. Among these, it is preferable to use a polythiophene compound. PEDOT / PSS doped with polystyrene sulfonic acid (poly4-styrene sulfonate; PSS) to poly 3,4-ethylenedioxythiophene (PEDOT) because it has lower contact impedance with the living body and has high conductivity. Is more preferable to use.

The content of the conductive polymer is preferably 0.20 parts by mass to 20 parts by mass with respect to 100 parts by mass of the conductive composition. When the content is within the above range, excellent conductivity, toughness and flexibility can be imparted to the conductive composition. The content of the conductive polymer is more preferably 2.5 parts by mass to 15 parts by mass, and further preferably 3.0 parts by mass to 12 parts by mass with respect to the conductive composition.

As the binder resin, a water-soluble polymer, a water-insoluble polymer, or the like can be used. As the binder resin, it is preferable to use a water-soluble polymer from the viewpoint of compatibility with other components contained in the conductive composition. The water-soluble polymer contains a polymer (hydrophilic polymer) that is completely insoluble in water and has hydrophilicity.

As the water-soluble polymer, a hydroxyl group-containing polymer or the like can be used. As the hydroxyl group-containing polymer, saccharides such as agarose, polyvinyl alcohol (PVA), modified polyvinyl alcohol, or a copolymer of acrylate and sodium acrylate can be used. 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 acetacetyl group-containing polyvinyl alcohol and diacetone acrylamide modified polyvinyl alcohol. As the diacetone acrylamide-modified polyvinyl alcohol, for example, a diacetone acrylamide-modified polyvinyl alcohol-based resin (DA-modified PVA-based resin) described in JP-A-2016-166436 can be used.

The content of the binder resin is preferably 5 parts by mass to 140 parts by mass with respect to 100 parts by mass of the conductive composition. When the content is within the above range, excellent conductivity, toughness and flexibility can be imparted to the conductive composition. The content of the binder resin is more preferably 10 parts by mass to 100 parts by mass, and further preferably 20 parts by mass to 70 parts by mass with respect to the conductive composition.

The cross-linking agent and the plasticizer have a function of imparting toughness and flexibility to the conductive composition. By imparting flexibility to the molded product of the electric composition, an electrode having elasticity was obtained. As a result, the probe 140 having elasticity can be produced.

The toughness is a property that achieves both excellent strength and elongation. The toughness does not include the property that one of the strength and the elongation is remarkably excellent, but the other is remarkably low, and includes the property of having an excellent balance of both strength and elongation.

Flexibility is a property that can suppress the occurrence of damage such as breakage in the bent portion after bending the molded body (electrode sheet) of the conductive composition.

The cross-linking agent cross-links the binder resin. By including the cross-linking agent in the binder resin, the toughness of the conductive composition can be improved. The cross-linking agent preferably has reactivity with a hydroxyl group. If the cross-linking agent has reactivity with a hydroxyl group, the cross-linking agent can react with the hydroxyl group of the hydroxyl group-containing polymer when the binder resin is a hydroxyl group-containing polymer.

Examples of the cross-linking 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 dialdehyde such as glyoxal; alkoxyl group-containing compounds and methylol groups. Examples include contained compounds. These may be used alone or in combination of two or more. Of these, a zirconium compound, an isocyanate compound, or an aldehyde compound is preferable from the viewpoint of reactivity and safety.

The content of the cross-linking agent is preferably 0.2 parts by mass to 80 parts by mass with respect to 100 parts by mass of the conductive composition. When the content is within the above range, excellent toughness and flexibility can be imparted to the conductive composition. The content of the cross-linking agent is more preferably 1 part by mass to 40 parts by mass, and more preferably 3.0 parts by mass to 20 parts by mass.

The plasticizer improves the tensile elongation and flexibility of the conductive composition. Examples of the plasticizer include glycerin, ethylene glycol, propylene glycol, sorbitol, and polyol compounds such as N-methylpyrrolidone (NMP), dimethylformamide (DMF), NN'-dimethylacetamide (DMAc), and dimethyl sulfoxide. Examples thereof include aprotic compounds such as (DMSO). These may be used alone or in combination of two or more. Among these, glycerin is preferable from the viewpoint of compatibility with other components.

The content of the plasticizer is preferably 0.2 parts by mass to 150 parts by mass with respect to 100 parts by mass of the conductive composition. When the content is within the above range, excellent toughness and flexibility can be imparted to the conductive composition. The content of the plasticizer is more preferably 1.0 part by mass to 90 parts by mass, and further preferably 10 parts by mass to 70 parts by mass with respect to 100 parts by mass of the conductive polymer.

At least one of the cross-linking agent and the plasticizer may be contained in the conductive composition. By including at least one of the cross-linking agent and the plasticizer in the conductive composition, the molded product of the conductive composition can improve toughness and flexibility.

When the conductive composition contains a cross-linking agent but no plasticizer, the molded product of the conductive composition can further improve toughness, that is, both tensile strength and tensile elongation, and is flexible. It is possible to improve the sex.

When the conductive composition contains a plasticizer but does not contain a cross-linking agent, the tensile elongation of the molded product of the conductive composition can be improved, so that the molded product of the conductive composition is tough as a whole. Can be improved. In addition, the flexibility of the molded product of the conductive composition can be improved.

It is preferable that both the cross-linking agent and the plasticizer are contained in the conductive composition. By including both the cross-linking agent and the plasticizer in the conductive composition, the molded product of the conductive composition is imparted with even better toughness.

In addition to the above components, the conductive composition may contain a surfactant, a softener, a stabilizer, a leveling agent, an antioxidant, an antioxidant, a leavening agent, a thickener, a colorant, or, if necessary. Various known additives such as a filler can be appropriately contained in an arbitrary ratio. Examples of the surfactant include silicone-based surfactants.

The conductive composition is prepared by mixing the above-mentioned components in the above-mentioned ratios.

The conductive composition can appropriately contain a solvent in an arbitrary ratio, if necessary. As a result, an aqueous solution of the conductive composition (an aqueous solution of the conductive composition) is 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 amides such as N, N-dimethylformamide. Examples of the aqueous solvent include water; methanol, ethanol, propanol, alcohol for isopropanol, and the like. Among these, it is preferable to use an aqueous solvent.

Any one or more of the conductive polymer, the binder resin, and the cross-linking agent may be used as an aqueous solution dissolved in a solvent. In this case, the above-mentioned aqueous solvent is preferable as the solvent.

The electronic device 150 is installed on the upper surface 122 of the base material layer 120 and is electrically connected to the wiring 131. The electronic device 150 processes a biological signal acquired via an electrode used as a probe 140. The electronic device 150 has a rectangular shape in a cross-sectional view. Two terminals 151 are provided on the lower surface (−Z direction) of the electronic device 150. Examples of the material of the terminal 151 include solder and a conductive paste. As shown in FIG. 2, the two terminals 151 of the electronic device 150 are electrically connected to the two terminals 131A, respectively.

As shown in the enlarged view of FIG. 2, the electronic device 150 includes an ASIC (application specific integrated circuit) 150A, an MPU (Micro Processing Unit) 150B, a memory 150C, and a wireless communication unit 150D as an example. , Is connected to the probe 140 and the battery 160 via the circuit unit 130.

The ASIC 150A includes an A / D (Analog to digital) converter. The electronic device 150 is driven by the electric power supplied from the battery 160 and acquires the 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 MPU 150B obtains the added average value of the biological signal acquired a plurality of times and stores it in the memory 150C. As an example, the electronic device 150 can continuously acquire biological signals for 24 hours or more. Since the electronic device 150 may measure a biological signal for a long time, it is devised to reduce power consumption.

The wireless communication unit 150D is a transceiver used when the test device of the evaluation test reads out the biological signal stored in the memory 150C in the evaluation test by wireless communication, and communicates at 2.4 GHz as an example. The evaluation test is, for example, a JIS 60601-2-47 standard test. The evaluation test is a test for confirming the operation performed after the completion of the biological sensor that detects a biological signal as a medical device. The evaluation test requires that the attenuation rate of the biological signal extracted from the biological sensor is less than 5% with respect to the biological signal input to the biological sensor. This evaluation test is performed on all finished 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 battery type. The battery 160 is an example of a battery. The battery 160 has two terminals (not shown) provided on its lower surface. The two terminals of the battery 160 are each electrically connected to the two terminals 131B. The capacity of the battery 160 is set so that the electronic device 150 can measure the biological signal for 24 hours or more, for example.

The cover 170 covers the upper surfaces of the base material layer 120, the circuit unit 130, the electronic device 150, and the battery 160. The cover 170 has a recess 170A on the base material layer 120 that houses the electronic device 150, the battery 160, and the like. The cover 170 is adhered to the upper surface of the base material layer 120 with the electronic device 150, the battery 160, and the like housed in the recess 170A.

The cover 170 not only serves as a cover for protecting the circuit unit 130, the electronic device 150, and the battery 160 on the base material layer 120, but also provides internal components from the impact applied to the stickable biosensor 100 from the upper surface side. It has a role as a protective shock absorbing layer. As the cover 170, for example, silicone rubber, soft resin, urethane or the like can be used.

The test terminal 180 has a base 181 and a pad 182, and a wiring 183. The test terminal 180 is used when performing an evaluation test. The wiring 183 is an example of the connection wiring for connecting the circuit unit 130, the probe 140, and the pad 182.

In the stick-on biosensor 100, the mesh-shaped probe 140 is exposed from the lower surface 112 of the pressure-sensitive adhesive layer 110. Therefore, when the terminal of the test device is brought into contact with the probe 140 in order to perform an evaluation test, the test device The pressure-sensitive adhesive layer 110 adheres to the terminal, and it is difficult to restore it to its original state.

Further, since the probe 140 is made of a conductive polymer, for example, when the terminal of the test device is in contact with only a part of the end of the probe 140, the terminal of the test device is brought into contact with the entire probe 140. The resistance value of the probe 140 becomes larger than that in the case of the above case, and it becomes difficult to evaluate correctly. This is because the entire probe 140 is attached to the skin 10 of the living body.

Therefore, the stick-on biosensor 100 is a test terminal that enables the biological signal for the test to be input to the electronic device 150 in a state substantially equal to the case where the skin 10 of the living body is stuck on the entire probe 140. Contains 180.

The base 181 is a base made of an insulator and extends in the + Y direction from the side surface of the cover 170. A pad 182 and a wiring 183 having a rectangular shape in a plan view are provided on the upper surface of the base 181. The portion of the base 181 connected to the cover 170 and provided with the wiring 183 is narrow in the X direction as in the wiring 183, and the portion provided with the pad 182 on the tip side is rectangular in a plan view. Such a base 181 may be made of an insulator, for example, urethane rubber.

The pad 182 is connected to the wiring 131 of the circuit unit 130 via the wiring 183. The pad 182 is provided on the upper surface of the base 181 and is set so that the impedance seen from the electronic device 150 is equal to the impedance seen from the electronic device 150 to the probe 140. As an example, the pad 182 and the wiring 183 may be made of copper, nickel, gold, an alloy thereof, or the like, similarly to the circuit unit 130. The pad 182 is provided outside the base material layer 120 and the cover 170 via the wiring 183.

The pad 182 of the test terminal 180 may have any shape as long as the terminals of the test device can be connected and the test signal can be directly input to the electronic device 150 without using the probe 140. Further, the base 181 may also have any shape.

As described above, the stick-on biosensor 100 includes a test terminal 180 separately from the probe 140 in addition to the mesh-shaped probe 140 exposed from the pressure-sensitive adhesive layer 110 and the lower surface 112 of 110A.

Therefore, the biological signal for the test can be input to the electronic device 150 in a state where the terminal of the test device is connected to the pad 182 without using the probe 140 for the input of the biological signal for the test. If the terminal of the test device is connected to the pad 182, the biological signal for the test can be input to the electronic device 150 under substantially the same conditions as when the terminal of the test device is connected to the entire probe 140.

Further, after inputting the biological signal for the test into the electronic device 150, the wireless communication unit 150D of the electronic device 150 is activated, the wireless communication unit 150D and the test device are connected by wireless communication, and the biological signal is transmitted by the test device. It should be read. Then, the attenuation rate of the biological signal extracted from the attached biosensor 100 with respect to the biological signal input to the electronic device 150 of the attached biosensor 100 may be obtained, and it may be evaluated whether or not the attenuation rate is less than 5%. In this way, the evaluation test of the stick-on biosensor 100 can be performed.

Therefore, it is possible to provide a stick-on biosensor 100 capable of easily inputting a biological signal for testing after completion.

FIG. 5 is an exploded view showing the stick-on biosensor 100M1 of the first modification of the embodiment. FIG. 6 is a view showing a cross section of a completed state corresponding to the arrow view of CC of FIG. In the following, the same components as those shown in FIGS. 1 to 4 are designated by the same reference numerals, and the description thereof will be omitted.

The stick-on biosensor 100M1 has, as main components, a pressure-sensitive adhesive layer 110, a base material layer 120, a circuit unit 130M1, a substrate 135, a probe 140M1, a fixing tape 145, an electronic device 150M1, a battery 160, a cover 170M1, and a test. Includes terminal 180.

In the stick-on biosensor 100M1, the electronic device 150M1 is divided into a plurality of parts, and the battery 160 is arranged on the −X direction side of the electronic device 150M1. Further, in the stick-on biosensor 100M1, the opening shapes of the through holes 113 and 123 of the pressure-sensitive adhesive layer 110 and the base material layer 120 are rectangular, and the probe 140M1 is rectangular in a plan view. Further, the fixing tape 145 attached from above the probe 140M1 has a rectangular annular shape in a plan view, and the pressure-sensitive adhesive layer 110MA1 and the base material layer 120MA1 attached from above the fixing tape 145 have a rectangular shape in a plan view.

The circuit unit 130M1 has a wiring 131M1, a frame 132M1, and a substrate 133M1. The stick-on biosensor 100M1 includes two such circuit units 130M1. The wiring 131M1 and the frame 132M1 are provided on the upper surface of the substrate 133M1 and are integrally formed. The wiring 131M1 and the frame 132M1 can be made of copper, nickel, gold, an alloy thereof, or the like.

The two circuit units 130M1 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 131M1 is connected to the electronic device 150M1 and the terminal 135A for the battery 160 via the wiring of the substrate 135. The frame 132M1 is a rectangular annular conductive member larger than the opening of the through hole 123 of the base material layer 120.

The substrate 133M1 has the same shape as the wiring 131M1 and the frame 132M1 in a plan view. The portion of the substrate 133M1 provided with the frame 132M1 has a rectangular annular shape larger than the opening of the through hole 123 of the base material layer 120. The frame 132M1 and the rectangular annular portion of the substrate 133M1 on which the frame 132M1 is provided are provided so as to surround the through hole 123 on the upper surface of the base material layer 120. The substrate 133M1 may be made of an insulator, and for example, a polyimide substrate or a film can be used. Since the base material layer 120 has adhesiveness (tack), the substrate 133M1 is fixed to the upper surface of the base material layer 120.

The substrate 135 is an insulator-made substrate on which the electronic device 150M1 and the battery 160 are mounted, and is provided on the upper surface 122 of the base material layer 120. The substrate 135 is fixed by the tack (adhesiveness) of the substrate layer. As the substrate 135, a polyimide substrate or a film can be used as an example. Wiring and terminals 135A for the battery 160 are provided on the upper surface of the substrate 135. The wiring of the board 135 is connected to the electronic device 150M1 and the terminal 135A, and is also connected to the wiring 131M1 of the circuit unit 130M1.

The probe 140M1 has a rectangular shape in a 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 like the probe 140 shown in FIG. .. The probe 140M1 is an example of an electrode that comes into contact with a subject. As shown in FIG. 5, the ladder-shaped side of the probe 140M1 may protrude at the ends (the portions of the four ends) of the probe 140M1 in the X and Y directions. The electrode used as the probe 140M1 may have a predetermined pattern shape. Examples of the predetermined electrode pattern shape include a mesh shape, a stripe shape, and a shape in which a plurality of electrodes are exposed from the sticking surface.

The fixing tape 145 is an example of the joint portion of the present embodiment. The fixing tape 145 is, for example, a copper tape. An adhesive is applied to the lower surface of the fixing tape 145. The fixing tape 145 has a rectangular annular shape larger than the openings of the through holes 113 and 123 in a plan view, and fixes the probe 140M1 to the frame 132M1. The fixing tape 145 may be a metal tape other than copper.

The fixing tape 145 may be a non-conductive tape such as a resin tape composed of a non-conductive resin base material and an adhesive, in addition to a tape having a metal layer such as a copper tape. A conductive tape such as a metal tape is preferable because the probe 140M1 can be joined (fixed) to the frame 132M1 of the circuit unit 130 and electrically connected.

The probe 140M1 is fixed to the frame 132M1 by a fixing tape 145 overlaid on the four end portions in a state where the four end portions are arranged on the frame 132M1. The fixing tape 145 is adhered to the frame 132M1 through a gap such as a hole 140A of the probe 140M1.

In this state, the four ends of the probe 140M1 are fixed to the frame 132M1 with the fixing tape 145, and the pressure-sensitive adhesive layer 110MA1 and the base material layer 120MA1 are laminated on the fixing tape 145 and the probe 140M1 to form a pressure-sensitive adhesive layer. When the 110MA1 and the base material layer 120MA1 are pressed downward, the probe 140M1 is pushed along the inner walls of the through holes 113 and 123 as shown in FIG. 6, and the pressure-sensitive adhesive layer 110MA1 enters the inside of the hole 140A of the probe 140M1. Is pushed in.

The probe 140M1 is pushed down to a position where the central portion is substantially flush with the lower surface 112 of the pressure-sensitive adhesive layer 110 in a state where the four end portions are fixed to the frame 132M1 by the fixing tape 145. Therefore, when the probe 140M1 is applied to the skin 10 of a living body (see FIG. 2), the pressure-sensitive adhesive layer 110MA1 is adhered to the skin 10 and the probe 140M1 can be brought into close contact with the skin 10.

Further, the peripheral portion of the rectangular annular shape surrounding the central portion of the pressure-sensitive adhesive layer 110MA1 in a plan view is located on the fixing tape 145. In FIG. 6, the upper surface of the pressure-sensitive adhesive layer 110MA1 is substantially flat, but the central portion may be recessed below the peripheral portion of the rectangular annular shape. The base material layer 120MA1 is superposed on a substantially flat upper surface of the pressure sensitive adhesive layer 110MA1.

Such the pressure-sensitive adhesive layer 110MA1 and the base material layer 120MA1 may be made of the same material as the pressure-sensitive adhesive layer 110 and the base material layer 120, respectively. Further, the pressure-sensitive adhesive layer 110MA1 may be made of a material different from that of the pressure-sensitive adhesive layer 110. Further, the base material layer 120MA1 may be made of a material different from that of the base material layer 120.

Although the thickness of each part is exaggerated in FIG. 6, the thickness of the pressure-sensitive adhesive layers 110 and 100MA1 is actually 10 μm to 300 μm, and the thickness of the base material layers 120 and 120MA1 is 1 μm to 300 μm. Is. The thickness of the wiring 131M1 is 0.1 μm to 100 μm, the thickness of the substrate 133M1 is about several hundred μm, and the thickness of the fixing tape 145 is 10 μm to 300 μm.

Further, as shown in FIG. 6, when the probe 140M1 and the frame 132M1 are in direct contact with each other to ensure an electrical connection, the fixing tape 145 may be a non-conductive resin tape or the like. Good.

Further, in FIG. 6, the fixing tape 145 covers the side surfaces of the frame 132M1 and the substrate 133M1 in addition to the probe 140M1, and reaches the upper surface of the base material layer 120. However, since the fixing tape 145 only needs to be able to bond the probe 140M1 and the frame 132M1, it does not have to reach the upper surface of the base material layer 120 and does not have to cover the side surface of the substrate 133M1. It does not have to be covered.

Further, the substrate 133M1 and the two substrates 135 may be one integrated substrate. In this case, wiring 131M1, two frames 132M1, and terminals 135A are provided on the surface of one substrate, and an electronic device 150M1 and a battery 160 are mounted.

The electronic device 150M1 also includes an ASIC 150A, an MPU 150B, a memory 150C, and a connector 150MD1. The electronic device 150M1 has a connector 150MD1 instead of the wireless communication unit 150D of the electronic devices 150 shown in FIGS. 1 to 3.

The cover 170M1 has a base 170MA and a protrusion 170MB protruding from the center of the base 170MA in the + Z direction. The base 170MA is a portion of the cover 170M1 located around the cover 170M1 in a plan view, and is a portion lower than the protruding portion 170MB. A recess 170MC is provided below the protrusion 170MB. In the cover 170M1, the lower surface of the base 170MA is adhered to the upper surface 122 of the base material layer 120. The substrate 135, the electronic device 150, and the battery 160 are housed in the recess 170MC. The cover 170M1 is adhered to the upper surface 122 of the base material layer 120 with the electronic device 150, the battery 160, and the like housed in the recess 170MC.

The cover 170M1 also has a through hole 170MD above the connector 150MD1. The connector of the test device for the evaluation test is inserted into the through hole 170MD and connected to the connector 150MD1.

In the stick-on biosensor 100M1, in the evaluation test, the biological signal stored in the memory 150C is read out by the test apparatus via the connector 150MD1. The through hole 170MD of the cover 170M1 may be filled with the same material as the cover 170M1 after the evaluation test is completed.

FIG. 7 is a diagram showing a stick-on biosensor 100M1. In FIG. 7, the stick-on biosensor 100M1 is shown in a simplified manner, and each component covered by the cover 170M1 is transparently shown.

After performing the evaluation test using the pad 182 of the test terminal 180 in the state shown in FIG. 7, the test terminal 180 may be cut off. In this case, the insulation of the cut portion may be ensured by applying a sealing agent or attaching an insulating seal to the cross section of the wiring 183 exposed on the end side of the cover 170M1.

FIG. 8 is a diagram showing a stick-on biosensor 100M2. The stick-on biosensor 100M2 has a configuration in which the cover 170M1 of the stick-on biosensor 100M1 shown in FIG. 7 is replaced with the cover 170M2. In FIG. 8, the stick-on biosensor 100M2 is shown in a simplified manner, and each component covered by the cover 170M2 is transparently shown.

After performing the evaluation test using the pad 182, the test terminal 180 may be covered with the terminal cover 171M2 as shown in FIG. The terminal cover 171M2 is an example of the second cover. The cover 170M2 of the stick-on biosensor 100M2 shown in FIG. 8 is obtained by attaching the terminal cover 171M2 covering the test terminal 180 to the cover 170M1 of the stick-on biosensor 100M1 shown in FIG. 7 after the evaluation test is completed.

The terminal cover 171M2 has a rectangular shape in a plan view, and projects in the + Y direction from the end extending in the X direction on the + Y direction side of the cover 170M2 to cover the entire test terminal 180 vertically. Such a terminal cover 171M2 can be made of silicone rubber, soft resin, urethane or the like like the cover 170M2. As an example, the terminal cover 171M2 may be provided with an adhesive layer to cover the top and bottom of the test terminal 180 and adhere to the end edge of the cover 170M1 to seal the test terminal 180. .. The terminal cover 171M2 may be configured to cover only the pad 182 on the upper surface side of the test terminal 180.

Further, the probe 140M2 as shown in FIG. 9 may be included instead of the mesh probe 140M1. The probe 140M2 is an example of an electrode that comes into contact with a subject. FIG. 9 is a diagram showing a probe 140M2 of a second modification of the embodiment. The probe 140M2 has a plurality of conductive portions 141M2 arranged in a matrix. The plurality of conductive portions 141M2 are exposed from the lower surface of the pressure-sensitive adhesive layer 110A and are connected to the connecting portion 210 (see FIG. 4). The probe 140M2 having such a plurality of conductive portions 141M2 may be produced by processing a conductive polymer. The conductive polymer may be molded so that the plurality of conductive portions 141M2 exposed from the lower surface of the pressure-sensitive adhesive layer 110A, the plurality of conductive portions 141M2, and the connecting portion 210 (see FIG. 4) are connected.

FIG. 10 is a diagram showing a stick-on biosensor 100M3 of a third modification of the embodiment. The stick-on biosensor 100M3 includes a test terminal 180M3 provided between the pressure-sensitive adhesive layer 110 and the cover 170 instead of the test terminal 180 of the stick-on biosensor 100M1 shown in FIG. 7. Further, the electronic device 150 and the cover 170 are included in place of the electronic device 150M1 and the cover 170M1.

The test terminal 180M3 has a base 181M3, a pad 182M3, and a wiring 183M3. The test terminal 180M3 is covered with a cover 170.

FIG. 11 is a diagram showing a state in which the terminal 500 of the test device is connected to the test terminal 180 in the cross section taken along the line DD of FIG. Since the test terminal 180M3 is covered with the cover 170, if the needle-shaped terminal 500 is pierced into the cover 170 and connected to the pad 182M3 of the test terminal 180M3, the biological signal for the test can be input.

Therefore, it is possible to provide a stick-on biosensor 100M3 that can easily input a biological signal for testing after completion.

FIG. 12 is a diagram showing a stick-on biosensor 100M4 of a fourth modification of the embodiment. The stick-on biosensor 100M4 includes a test terminal 180M4. The test terminal 180M4 protrudes from both ends of the cover 170 in the X direction and has a base 181 and a pad 182, and a wiring 183M4. The wiring 183M4 is connected to the wiring 131 of the circuit unit 130 by bypassing along the outer edge of the probe 140. After the evaluation test is completed, the test terminal 180M4 may be sealed with a cover similar to the cover 171 shown in FIG.

FIG. 13 is a diagram showing a stick-on biosensor 100M5 of the fifth modification of the embodiment. The stick-on biosensor 100M5 includes a cover 170M5 instead of the cover 170 of the stick-on biosensor 100M3 shown in FIG. The cover 170M5 has an opening 171M5 provided on the test terminal 180M3 and a sealing portion 172M5 that can be attached to and detached from the opening 171M5 and can seal the opening 171M5. The opening 171M5 may be provided at a position overlapping the test terminal 180M3.

FIG. 14 is a cross-sectional view showing a state in which the terminal 500M5 of the test device is connected to the test terminal 180M3 of the stick-on biosensor 100M5.

When connecting the terminal 500M5 of the test device to the pad 182M3, if the sealing portion 172M5 is removed, the terminal 500M5 is inserted into the opening 171M5 and connected to the pad 182M3, a biological signal for testing can be input. it can.

Therefore, it is possible to provide a stick-on biosensor 100M5 that can easily input a biological signal for testing after completion.

Although the stick-on biosensor of the exemplary embodiment of the present invention has been described above, the present invention is not limited to the specifically disclosed embodiment and deviates from the scope of claims. It is possible to make various modifications and changes.

100, 100M3, 100M4, 100M5 Stick-on biosensor 110 Pressure-sensitive adhesive layer 120 Base material layer 130 Circuit part 140 Probe 150 Electronic device 160 Battery 170, 170M5 Cover 171M5 Opening 172M5 Sealing part 180, 180M3, 180M4 Test terminal 182 , 182M3 pad

Claims (7)

A pressure-sensitive adhesive layer with a sticking surface that can be stuck to the subject,
With electrodes
A base material layer provided on the opposite surface of the pressure-sensitive adhesive layer to which it is attached,
An electronic device provided on the base material layer and processing a biological signal acquired via the electrode.
A battery provided on the substrate layer and supplying electric power to the electronic device,
A circuit unit provided on the base material layer and connecting the electrode and the electronic device,
A cover provided on the base material layer and covering the electronic device, the battery, and the circuit portion.
A patch-type biosensor including the circuit unit or a pad connected to the electrode. Further including a connection wiring for connecting the circuit unit or the electrode and the pad.
The stick-on biosensor according to claim 1, wherein the pad is provided outside the base material layer and the cover via the connection wiring. The stick-on biosensor according to claim 2, further comprising a second cover for sealing the pad with the electronic device, the battery, and the circuit portion covered by the cover. The stick-on biosensor according to claim 1, wherein the pad is provided on the base material layer and is covered with the cover. The stick-on biosensor according to claim 4, wherein the cover has an opening provided at a position overlapping the pad and a sealing portion that is detachably attached to the opening and can seal the opening. The stick-on biosensor according to any one of claims 1 to 5, further comprising a substrate on which the electronic device and the battery are mounted and provided on the base material layer. The stick-on biosensor according to any one of claims 1 to 6, wherein the circuit portion is formed and further includes a second substrate provided on the base material layer.

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