Wearable Devices

Abstract

To provide a wearable device capable of stably acquiring continuous biological information, and a detection method.SOLUTION: A wearable device comprises a detection part and a flexible substrate. The detection part detects biological information of an object person. The flexible substrate is disposed in a first direction of the detection part, includes an electronic component electrically connected to the detection part, and has flexibility. The detection part includes an electrode part having an electrode to be electrically connected to the electronic component, a first plating layer disposed in a second direction opposite to the first direction of the electrode part and containing gold, and a second plating layer disposed in the second direction of the first plating layer and containing a metal other than the gold.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] SUMMARY OF THE DISCLOSURE The present invention relates to a wearable device and a detection method. [Background technology]

[0002] In recent years, various technologies have been proposed to detect human biometric information using wearable devices that can be worn by humans. For example, a technology has been proposed in which a small and lightweight electrocardiogram sensor is attached to the skin with adhesive tape or the like to obtain continuous electrocardiogram signals. It is expected that such wearable devices will be used to obtain continuous biometric information in daily life. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 6539827 [Patent Document 2] Patent No. 6718183 [Patent Document 3] Patent No. 6795003 Summary of the Invention [Problem to be solved by the invention]

[0004] However, wearable devices may not be able to acquire biometric information due to various factors in daily life. For example, wearable devices may bend and break due to the movement of the human body. In addition, sweat (moisture) may cause discomfort to the wearer, or the wearer may peel off from the skin. Therefore, an object of the present invention is to provide a wearable device and a detection method capable of stably acquiring continuous biometric information. [Means for solving the problem]

[0005] In order to solve the above-mentioned problems and achieve the object, the present invention is a wearable device for acquiring biometric information of a subject, comprising a detection unit for detecting the biometric information, and a flexible substrate having flexibility and an electronic component arranged in a first direction of the detection unit and electrically connected to the detection unit, wherein the detection unit has an electrode unit having an electrode electrically connected to the electronic component, a first plating layer arranged in a second direction opposite to the first direction of the electrode unit and containing gold, and a second plating layer arranged in the second direction of the first plating layer and containing a metal other than gold.

[0006] The present invention also provides a detection method that includes detecting an abnormality in the subject based on the biological information acquired using the wearable device. Effect of the Invention

[0007] According to the present invention, it is possible to provide a wearable device and a detection method capable of stably acquiring continuous biological information. [Brief description of the drawings]

[0008] [Figure 1] FIG. 1 is a diagram showing an example of the structure of a wearable device 100 according to an embodiment. [Diagram 2] FIG. 2 is a diagram showing an example of the structure of the flexible substrate 110 and the electronic component section 120 according to the embodiment. [Diagram 3] FIG. 3 is a diagram showing an example of wiring on the flexible substrate 110 and the rigid substrate 121 according to the embodiment. [Figure 4] FIG. 4 is a diagram showing an example of the structure of the adhesive portion 130 according to the embodiment. [Diagram 5] FIG. 5 is a diagram showing an example of a layer configuration of the plating layer 150 according to the embodiment. [Figure 6] FIG. 6 is a diagram for explaining a method of attaching the wearable device 100 according to the embodiment. [Figure 7] FIG. 7 is a diagram showing an example of the structure of the adhesive portion 130 according to the first modification. [Figure 8] FIG. 8 is a diagram showing an example of a layer configuration of a plating layer 150 according to the second modification. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] A wearable device and a detection method according to an embodiment will be described below with reference to the accompanying drawings. Note that the embodiment described below is not limited to the following description. The embodiment described below can be combined with other embodiments or conventional techniques as long as there is no inconsistency in the configuration. The embodiment described below can include the configuration described in Japanese Patent No. 6539827.

[0010] Note that the configurations illustrated below are not limited to the illustrated contents. For example, the dimensions and angles of each part illustrated below can be changed as appropriate within the scope that does not impair the functionality of the wearable device.

[0011] (Embodiment) An example of the structure of a wearable device 100 according to an embodiment will be described with reference to Fig. 1. Fig. 1 is a diagram showing an example of the structure of a wearable device 100 according to an embodiment. Fig. 1 illustrates a perspective view of the wearable device 100.

[0012] The wearable device 100 is a device (sensor device, wearable device) that acquires biometric information of a subject. For example, the wearable device 100 is formed in a substantially rectangular (striped) shape and is attached to the skin (skin) of a subject. The subject is a person from whom biometric information is acquired, and corresponds to a person who wears the wearable device 100 (wearer). Note that the term "substantially rectangular" does not only mean a rectangle having four corners (vertices) and opposite sides that are parallel to each other, but also includes, for example, a shape with four rounded corners and a shape with each side having a slight curvature, as shown in FIG. 1.

[0013] For example, the wearable device 100 detects an electrocardiogram signal as bioinformation. In the following description, the wearable device 100 that acquires an electrocardiogram signal will be described, but the embodiment is not limited to this. For example, the wearable device 100 may be a sensor device that acquires bioinformation other than an electrocardiogram signal, such as body temperature or blood pressure. Furthermore, the wearable device 100 is not limited to acquiring one type of bioinformation, and can also acquire multiple types of bioinformation.

[0014] 1, the wearable device 100 has a flexible substrate 110, an electronic component unit 120, and an adhesive unit 130. The flexible substrate 110, the electronic component unit 120, and the adhesive unit 130 will be described in detail later.

[0015] Note that the contents described in FIG. 1 are merely an example, and are not limited to the contents shown in the figure. For example, FIG. 1 illustrates a case where the wearable device 100 is substantially rectangular, but the embodiment is not limited to this. The wearable device 100 can be formed in any shape, such as a square, a circle, or an ellipse. Among these shapes, the wearable device 100 is preferably substantially rectangular or elliptical, and is particularly preferably substantially rectangular or elliptical with an aspect ratio (ratio of major axis to minor axis) of 1.1 or more. With the wearable device 100 of such a shape, the distance between the electrodes can be set wide in the same area, making it possible to obtain continuous biological information with higher sensitivity. In addition, it is desirable that the end shape of the wearable device 100 is not angular. With such a shape, the device is less likely to come off from the subject's skin and does not cause discomfort.

[0016] In this embodiment, when the wearable device 100 is attached to the skin of a subject, the direction away from the skin (first direction) may be described as "upper". Furthermore, the direction opposite to the "first direction" (second direction) may be described as "lower".

[0017] An example of the structure of the flexible substrate 110 and the electronic component section 120 according to the embodiment will be described with reference to Fig. 2. Fig. 2 is a diagram showing an example of the structure of the flexible substrate 110 and the electronic component section 120 according to the embodiment. The upper part of Fig. 2 illustrates a top view of the flexible substrate 110 and the electronic component section 120. The middle part of Fig. 2 illustrates a front view of the flexible substrate 110 and the electronic component section 120. The lower part of Fig. 2 illustrates a bottom view of the flexible substrate 110 and the electronic component section 120.

[0018] The flexible substrate 110 is a substrate on which a conductor is wired and has flexibility so as to flexibly follow the movements of a person wearing the wearable device 100. The flexible substrate 110 is, for example, an FPC (Flexible Printed Circuits) formed in a substantially rectangular shape. The flexible substrate 110 can be formed using any material, such as polyimide resin, polyamide resin, polyester resin, epoxy resin, and acrylic resin. The flexible substrate 110 preferably has a thickness of 0.10 mm or more and less than 0.80 mm, and more preferably has a thickness of 0.15 mm or more and less than 0.60 mm. The layer having the flexible substrate 110 is also called a "flexible layer." The flexible substrate 110 is also called a "flexible substrate."

[0019] For example, flexible substrate 110 has on its first surface (top surface) conductors that electrically connect the electronic components mounted on wearable device 100. Flexible substrate 110 also has on its second surface (bottom surface) opposite to the first surface three electrodes 111, 112, and 113. Here, electrodes 111 and 112 are set as a positive electrode and a negative electrode, and electrode 113 located between the positive electrode and the negative electrode is set as a reference electrode, making it possible to acquire biological information more stably.

[0020] The electrodes 111, 112, and 113 are electrodes for detecting an electrocardiogram (ECG) of a subject. Each of the electrodes 111, 112, and 113 is electrically connected to a conductor wired on the upper surface of the flexible substrate 110 via a through hole. The layer having the three electrodes 111, 112, and 113 is also called an "electrode layer." The electrode layer is an example of a "detection unit" that detects biological information.

[0021] 2, the case where there are three electrodes for detecting an electrocardiogram signal is described, but the embodiment is not limited to this. The number of electrodes for detecting an electrocardiogram signal can be set as necessary.

[0022] The electronic component section 120 is electrically connected to conductors wired on the upper surface of the flexible substrate 110, and includes various electronic components that control processing in the wearable device 100. For example, the electronic component section 120 controls power supply to each section in the wearable device 100, amplification and collection of electrocardiogram signals detected by the electrodes 111, 112, and 113, and output of the collected electrocardiogram signals. The layer having the electronic component section 120 is also called the "electronic component layer."

[0023] Here, the electronic component part 120 is laminated on the hard substrate 121. The hard substrate 121 is a substrate laminated on the flexible substrate 110 and supports the electronic component part 120. For example, the hard substrate 121 can be any hard substrate such as a paper phenol substrate, a paper epoxy substrate, a glass composite substrate, a glass epoxy substrate, or a glass polyimide substrate. Among such hard substrates, a paper epoxy substrate, a glass epoxy substrate, or a glass polyimide substrate is preferable, and a glass epoxy substrate is particularly preferable. The hard substrate 121 preferably has a thickness of 0.30 mm or more and less than 3.0 mm, and more preferably has a thickness of 0.50 mm or more and less than 2.0 mm. Such a hard substrate makes it easier to support the electronic component part 120, so that it is possible to acquire bioinformation more stably.

[0024] By being laminated on the hard substrate 121, the electronic component unit 120 has improved durability against bending (bending) compared to when it is laminated directly on the flexible substrate 110 or when it is installed inside the flexible substrate 110. As a result, the wearable device 100 reduces the risk of damage such as the solder of the electronic component unit 120 coming off and breaking due to bending, and it becomes possible to stably acquire continuous biological information.

[0025] Furthermore, the hard substrate 121 is disposed at an end of the flexible substrate 110. This reduces the number of wires on the flexible substrate 110 to only a few wires directed to the electronic component unit 120 (hard substrate 121), simplifying the wiring. As a result, the wearable device 100 can reduce the risk of wire breakage, making it possible to continuously and stably acquire biological information.

[0026] Furthermore, the hard substrate 121 is disposed at a position corresponding to the electrode 112 of the flexible substrate 110, and more preferably at a position corresponding to the electrodes 112 and 113. This makes the electrodes 112 and the like robust against bending. As a result, the wearable device 100 reduces the risk of damage to the electrodes 112 and the like due to bending, and thus makes it possible to continuously and stably acquire biological information.

[0027] Furthermore, the area of ​​the hard substrate 121 is preferably 5 to 50% of the area of ​​the flexible substrate 110, and more preferably 20 to 40% of the area of ​​the flexible substrate 110. If the area of ​​the hard substrate 121 is within this range, the wearable device 100 is less likely to be damaged and the electronic component unit 120 is more easily supported, making it possible to acquire biometric information more stably. The area of ​​the hard substrate 121 is the area of ​​the surface of the hard substrate 121 that faces the flexible substrate 110. The area of ​​the flexible substrate 110 is the area of ​​the surface of the flexible substrate 110 that faces the hard substrate 121.

[0028] Note that the contents described in FIG. 2 are merely an example, and are not limited to the contents shown in the figure. For example, in FIG. 2, a case where the electronic component unit 120 is laminated on the hard substrate 121 is described, but the embodiment is not limited to this. The electronic component unit 120 can be laminated on any member as long as the member is harder (less flexible) than the flexible substrate 110. In other words, the electronic component unit 120 is laminated on an "isolation layer" for isolating the flexible substrate 110 from bending. As the isolation layer, for example, a flexible substrate made of a material harder than the flexible substrate 110, or a flexible substrate made thicker than the flexible substrate 110, can be arbitrarily applied. Note that the isolation layer is also called a "support layer" that supports the electronic component unit 120.

[0029] Furthermore, the electronic component unit 120 does not necessarily have to be provided on the hard substrate 121. For example, the electronic component unit 120 may be provided directly on the flexible substrate 110 without the hard substrate 121. In other words, the flexible substrate 110 may have the electronic component unit 120 electrically connected to the detection unit.

[0030] 2 are not limited to the above-mentioned materials. For example, the materials of the flexible substrate 110, the electrodes 111, 112, and 113, the electronic component part 120, and the hard substrate 121 can be any known material within the scope of not impairing the functions of the above-mentioned parts.

[0031] An example of wiring on the flexible substrate 110 and the rigid substrate 121 according to the embodiment will be described with reference to Fig. 3. Fig. 3 is a diagram showing an example of wiring on the flexible substrate 110 and the rigid substrate 121 according to the embodiment. The upper part of Fig. 3 illustrates wiring in a top view of the rigid substrate 121. The middle part of Fig. 3 illustrates wiring in a top view of the flexible substrate 110. The lower part of Fig. 3 illustrates wiring in a front view of the flexible substrate 110 and the rigid substrate 121.

[0032] As shown in Fig. 3, a plurality of lead wires 140 are arranged on the upper surface of the hard substrate 121. The lead wires 140 electrically connect various electronic components included in the electronic component section 120. Note that the wiring branched into three shown in the upper part of Fig. 3 is merely an example, and the embodiment is not limited thereto. The lead wires 140 on the hard substrate 121 are appropriately insulated and connected to the lead wires 140 on the flexible substrate 110.

[0033] Lead wires 140 for connecting the three electrodes 111, 112, and 113 to the electronic component section 120 are disposed on the upper surface of the flexible substrate 110. Through holes are formed at positions 110A, 110B, and 110C of the flexible substrate 110. The lead wires 140 are connected to the three electrodes 111, 112, and 113 via the through holes formed at each position. The lead wires 140 extending from the electrodes 111, 112, and 113 are individually connected to the lead wires 140 on the hard substrate 121 while being insulated.

[0034] Note that the contents described in Fig. 3 are merely an example and are not limited to the contents shown in the figure. For example, in the lower part (front view) of Fig. 3, the lead wires 140 arranged on the upper surface of each board are shown separated from each board, but this is intended to clearly show the lead wires 140, and in reality the two are not separated.

[0035] 3, the lead wires 140 on the hard substrate 121 are bundled at one point, but they may be bundled at several points and connected to the flexible substrate 110. However, to simplify the wiring, it is preferable to bundle the lead wires at a small number of points.

[0036] An example of the structure of the adhesive portion 130 according to the embodiment will be described with reference to Fig. 4. Fig. 4 is a diagram showing an example of the structure of the adhesive portion 130 according to the embodiment. The upper part of Fig. 4 illustrates a front view of the adhesive portion 130. The lower part of Fig. 4 illustrates a bottom view of the adhesive portion 130.

[0037] The adhesive section 130 is disposed on the bottom surface of the flexible substrate 110, and is a member having an adhesive force for attaching the flexible substrate 110 and the electronic component section 120 to the skin of a subject. The adhesive section 130 has five layers: a waterproof layer 131, a conductive gel layer 132, a waterproof layer 133, a water absorbing layer 134, and a skin adhesive layer 135.

[0038] The waterproof layer 131 is disposed on the bottom surface of the flexible substrate 110 (electrode layer) and is a layer having waterproof and insulating properties. For example, the waterproof layer 131 includes a material having excellent waterproof properties, such as polyester resin, polyurethane resin, polyethylene resin, polypropylene resin, and nylon resin. The waterproof layer 131 has holes for contacting the electrodes 111, 112, and 113 with the conductive gels 132A, 132B, and 132C described below. In the example of FIG. 4, the waterproof layer 131 has a circular hole having a diameter of 15 mm.

[0039] The conductive gel layer 132 is disposed on the bottom surface of the waterproof layer 131, is capable of coming into contact with the subject's skin, and is electrically connected to the electrodes 111, 112, and 113. For example, the conductive gel layer 132 has three conductive gels 132A, 132B, and 132C. The conductive gel layer 132 is an example of a "detection unit" that detects biological information.

[0040] Each of the conductive gels 132A, 132B, and 132C is a hydrogel (water-containing gel) having electrical conductivity. In the example of FIG. 4, each of the conductive gels 132A, 132B, and 132C has a circular shape with a diameter of 17 mm. Of these, the conductive gel 132A is disposed on the bottom surface of the electrode 111 and is electrically connected to the electrode 111. The conductive gel 132B is disposed on the bottom surface of the electrode 112 and is electrically connected to the electrode 112. The conductive gel 132C is disposed on the bottom surface of the electrode 113 and is electrically connected to the electrode 113.

[0041] In addition, in the area of ​​the conductive gel layer 132 where the three conductive gels 132A, 132B, 132C are not present, nothing may be placed therein, or any arbitrary member may be placed therein. If nothing is placed therein, the waterproof layer 131 and the waterproof layer 133 will be directly bonded to each other. If any arbitrary member is placed therein, it is preferable to place a member having insulating and waterproof properties.

[0042] The waterproof layer 133 is disposed on the bottom surface of the conductive gel layer 132 and is a layer having waterproof and insulating properties. For example, the waterproof layer 133 includes a material having excellent waterproof properties, such as polyester resin, polyurethane resin, and nylon resin. The waterproof layer 133 has holes for contacting each of the conductive gels 132A, 132B, and 132C with the subject's skin. In the example of FIG. 4, the waterproof layer 133 has a circular hole having a diameter of 15 mm. The bottom surface of the conductive gel layer 132 corresponds to the surface of the conductive gel layer 132 opposite to the surface adjacent to the electrode layer.

[0043] The water absorption layer 134 is disposed on the bottom surface of the waterproof layer 133 and is a layer having water absorption properties. For example, the water absorption layer 134 includes a nonwoven fabric. The water absorption layer 134 is not limited to a nonwoven fabric, and may be made of, for example, a fiber having water absorption properties. As such fibers, polyester resin, polyurethane resin, polypropylene resin, nylon resin, etc. are preferably used as the material, and polyurethane resin or polypropylene resin is particularly preferably used as the material. Fibers made of such materials have excellent breathability and elasticity, so that the effect of the water absorption layer 134 described later is easily exhibited. In addition, the bottom surface of the waterproof layer 133 corresponds to the surface of the waterproof layer 133 opposite to the surface adjacent to the conductive gel layer 132.

[0044] The water-absorbing layer 134 has holes for contacting the conductive gels 132A, 132B, and 132C with the skin of the subject. In the example of Fig. 4, the water-absorbing layer 134 has circular holes with a diameter of 22 mm.

[0045] The water absorption layer 134 has the function of absorbing sweat (moisture) generated on the skin of the subject and dissipating it to the outside of the wearable device 100. Therefore, the water absorption layer 134 prevents the hydrogel (conductive gel layer 132) from absorbing moisture and expanding, thereby reducing discomfort caused by the expansion. In addition, by preventing the hydrogel from expanding, the water absorption layer 134 reduces the possibility that the hydrogel will peel off from adjacent layers. This reduces the possibility that the wearable device 100 will peel off from the wearer's skin due to sweat, and further allows the device to be attached continuously for up to about two weeks.

[0046] Furthermore, by providing the water absorption layer 134, the wearable device 100 can reduce effects on the human body (skin), such as cytotoxicity, sensitization (allergic reaction), and irritation. In particular, when a nonwoven fabric is used as the water absorption layer 134, the effects on the human body can be further reduced.

[0047] In addition, the holes in the water absorption layer 134 are larger than the holes in the waterproof layer 133. Therefore, the ends (edges) of the holes in the water absorption layer 134 are spaced apart from the conductive gels 132A, 132B, and 132C, which reduces the possibility that moisture absorbed by the water absorption layer 134 will pass through the ends of the holes and be absorbed by the conductive gels 132A, 132B, and 132C.

[0048] The skin adhesive layer 135 is disposed on the bottom surface of the water absorbing layer 134 and is a layer that can be adhered to the skin of the subject. For example, the skin adhesive layer 135 includes an acrylic adhesive or a hydrocolloid. The skin adhesive layer 135 has holes for contacting each of the conductive gels 132A, 132B, and 132C with the skin of the subject. In the example of FIG. 4, the waterproof layer 133 has a circular hole with a diameter of 22 mm.

[0049] 4 is merely an example and is not limited to the illustrated content. For example, the shape and size of conductive gel layer 132 are not limited to the illustrated content and can be changed as desired. In response to changes in the shape and size of conductive gel layer 132, the shapes and sizes of the holes (or grooves) in waterproof layer 131, waterproof layer 133, water absorption layer 134, and skin adhesive layer 135 are also changed. The holes (or grooves) in waterproof layer 131, waterproof layer 133, water absorption layer 134, and skin adhesive layer 135 are examples of openings.

[0050] Although not shown in FIG. 4, the adhesive section 130 may have an adhesive layer for adhering each layer in addition to the above-mentioned five layers. The adhesive layer may be made of any adhesive, such as a liquid or sheet-like adhesive. However, when each of the above-mentioned layers has an adhesive function with the adjacent layers, the adhesive layer may be omitted. For example, when the skin adhesive layer 135 has an adhesive function with the water absorption layer 134, the adhesive layer may be omitted between the water absorption layer 134 and the skin adhesive layer 135. Furthermore, when the waterproof layer 133 has an adhesive function with the water absorption layer 134, the adhesive layer may be omitted between the waterproof layer 133 and the water absorption layer 134.

[0051] 4 are not limited to the above-mentioned materials. For example, the materials of waterproof layer 131, conductive gel layer 132, waterproof layer 133, water absorption layer 134, and skin adhesive layer 135 can be any known material within the scope of not impairing the functions of the above-mentioned parts.

[0052] Here, the plating layer 150 formed on the surface of the electrode 111 will be described with reference to Fig. 5. Fig. 5 is a diagram showing an example of the layer configuration of the plating layer 150 according to an embodiment. Note that the plating layers formed on the surfaces of the electrodes 112 and 113 are similar to the plating layer formed on the surface of the electrode 111, and therefore a description thereof will be omitted.

[0053] 5 corresponds to the direction toward the skin (second direction) when the wearable device 100 is attached to the skin of a subject, and the "downward direction" corresponds to the direction away from the skin (first direction). That is, in FIG. 5, the conductive gel 132A is disposed above the plating layer 150 (second direction).

[0054] 5, the plating layer 150 is disposed above the electrode 111 (in a second direction). The plating layer 150 includes a first plating layer 151, a second plating layer 152, and a third plating layer 153.

[0055] Here, the electrode 111 has a layer containing copper as the outermost layer 111A in contact with the plating layer 150. The thickness of the outermost layer 111A is, for example, 33 μm. The outermost layer 111A is adhered by an adhesive layer 111B containing polyimide (PI). The thickness of the adhesive layer 111B is, for example, 26 μm.

[0056] The first plating layer 151 is disposed above the electrode 111 and is a layer containing gold. For example, the first plating layer 151 is a gold (Au) strike. A gold strike is a very thin plating formed before forming another plating layer. Strike plating is generally formed by plating at a high current density in a short time, and has high durability and high adhesion to other plating layers. Such a first plating layer 151 can particularly reduce ion migration, in which metal ions such as copper and nickel contained in the electrode portion are eluted into the conductive gel portion.

[0057] The thickness of the first plating layer 151 is, for example, preferably not less than 0.1 nm and less than 1 μm, more preferably not less than 0.1 nm and less than 100 nm, and particularly preferably not less than 1 nm and less than 50 nm.

[0058] The second plating layer 152 is disposed above the first plating layer 151 and is a layer containing a metal other than gold. For example, the second plating layer 152 is a thin film (plating) formed of palladium (Pd), silver (Ag), chromium (Cr), zinc (Zn), rhodium (Rh), platinum (Pt), or the like, and has a thickness of 0.1 μm. The second plating layer 152 is preferably made of palladium (Pd) because it can improve adhesion with the first plating layer and reduce ion migration.

[0059] The thickness of second plating layer 152 is, for example, preferably not less than 1 nm and less than 10 μm, more preferably not less than 1 nm and less than 1 μm, and particularly preferably not less than 10 nm and less than 500 nm.

[0060] The third plating layer 153 is disposed above the second plating layer 152 and is a layer containing gold. For example, the third plating layer 153 is a thin film formed of gold (Au), silver (Ag), platinum (Pt), or the like, and has a thickness of 0.05 μm. The third plating layer 153 is preferably made of gold (Au) because it has good adhesion to the second plating layer and can reduce ion migration.

[0061] The thickness of the third plating layer 153 is, for example, preferably not less than 1 nm and not more than 10 μm, more preferably not less than 1 nm and not more than 1 μm, and particularly preferably not less than 10 nm and not more than 500 nm.

[0062] Each layer included in the plating layer 150 can be formed by, for example, electrolytic plating or electroless plating, but may be formed by any method without being limited thereto. Any known technique can be applied as a method for forming each layer.

[0063] Although not shown in FIG. 5, a printed layer may be provided above the plating layer 150. The printed layer is a layer formed by printing. Examples of materials for forming the printed layer include metal filler and curable resin. The printed layer may be one layer or two or more layers. For example, the printed layer may include a first printed layer that is disposed in the second direction of the third plating layer and contains silver and curable resin, and a second printed layer that is disposed in the second direction of the first printed layer and contains silver, silver chloride (AgCl) and curable resin. By providing the printed layer, durability and scratch resistance can be improved.

[0064] Note that the contents described in FIG. 5 are merely examples and are not limited to those shown in the drawings. For example, the thickness of each layer shown in FIG. 5 is not limited to the values ​​shown in the drawings and can be set arbitrarily. Also, for example, at least one of the three electrodes 111, 112, and 113 may have the plating layer 150. Also, for example, the materials of the second plating layer and the third plating layer shown in FIG. 5 are merely examples and may be changed to other materials. Also, the third plating layer may not necessarily be provided. Other configurations of the plating layers will be described in Modification 2.

[0065] A method of attaching the wearable device 100 according to the embodiment will be described with reference to Fig. 6. Fig. 6 is a diagram for explaining a method of attaching the wearable device 100 according to the embodiment.

[0066] For example, the wearable device 100 is distributed in a state in which the flexible substrate 110, the electronic component unit 120, and the adhesive unit 130 are integrated together. That is, as shown in Fig. 6, the flexible substrate 110 and the electronic component unit 120 are pre-attached to the upper surface of the adhesive unit 130. Note that the upper surface of the adhesive unit 130 corresponds to the upper surface of the waterproof layer 131, and corresponds to the surface of the waterproof layer 131 opposite to the surface adjacent to the conductive gel layer 132.

[0067] Although not shown in FIG. 6, the bottom surface of the wearable device 100 (i.e., the bottom surface of the skin adhesive layer 135) is covered with a release paper. A user of the wearable device 100 peels off the release paper to expose the bottom surface of the skin adhesive layer 135. Then, the user attaches the bottom surface of the skin adhesive layer 135 to any position on the subject's skin. The bottom surface of the adhesive part 130 corresponds to the bottom surface of the skin adhesive layer 135, and corresponds to the surface of the skin adhesive layer 135 opposite to the surface adjacent to the water absorption layer 134. The user of the wearable device 100 corresponds to medical professionals such as doctors, the subject, and those who support the subject in medical terms or in daily life.

[0068] That is, the wearable device 100 has a layer configuration including, in order from the side closest to the human body (skin), a skin adhesive layer 135, a water absorbing layer 134, a waterproof layer 133, a conductive gel layer 132, a waterproof layer 131, an electrode layer (electrodes 111, 112, 113), a flexible layer (flexible substrate 110), an isolation layer (hard substrate 121), and an electronic component layer (electronic component section 120). The electrode section (electrodes 111, 112, 113) of the wearable device 100 attached to any position on the skin detects biological information from the human body via the conductive gel section (132).

[0069] Note that the content described in Fig. 6 is merely an example, and is not limited to the illustrated content. For example, Fig. 6 describes a representative example in which flexible substrate 110, electronic component section 120, and adhesive section 130 are distributed in an integrated state, but the embodiment is not limited to this. For example, each section included in wearable device 100 may be manufactured and distributed by an individual vendor.

[0070] 6, for convenience of illustration, each layer is shown as having the same thickness, but the thickness of each layer can be set arbitrarily. Also, since the thicknesses of skin adhesive layer 135, water absorption layer 134, and waterproof layer 133 are extremely thin compared to the size (diameter) of the holes of skin adhesive layer 135, water absorption layer 134, and waterproof layer 133, when wearable device 100 is attached to the skin of the subject, conductive gel layer 132 is easily brought into contact with the subject's skin.

[0071] In the above embodiment, the layer having the three electrodes 111, 112, and 113 is described as an "electrode layer", but since the electrodes 111, 112, and 113 are small and exist as dots compared to the flexible layer and the isolation layer, they do not necessarily have to be called "layers". For example, the three electrodes 111, 112, and 113 may be called "electrode parts".

[0072] In the above embodiment, the layer having the three conductive gels 132A, 132B, and 132C is described as a "conductive gel layer," but since the conductive gels 132A, 132B, and 132C are small compared to the flexible layer and the isolation layer and exist in a dot shape, they do not necessarily have to be called a "layer." For example, the three conductive gels 132A, 132B, and 132C may be called a "conductive gel portion."

[0073] As described above, the wearable device 100 includes a detection unit (electrode layer and conductive gel layer 132), a flexible layer (flexible substrate 110), an isolation layer (hard substrate 121), and an electronic component layer (electronic component unit 120). The detection unit detects biometric information. The flexible layer has a conductor electrically connected to the detection unit. The isolation layer is laminated on the flexible layer and is harder than the flexible layer. The electronic component layer is laminated on the isolation layer and includes electronic components electrically connected to the conductor. This allows the wearable device 100 to stably acquire continuous biometric information. For example, since the wearable device 100 has an isolation layer for isolating the electronic component layer from bending of the flexible layer, the risk of damage to the electronic component layer due to bending is reduced, and therefore it is possible to stably acquire continuous biometric information.

[0074] In other words, the wearable device 100 includes a detection unit, a first layer, a second layer, and a third layer. The detection unit detects biological information. The first layer is disposed in a first direction of the detection unit, has a conductor electrically connected to the detection unit, and is flexible. The second layer is disposed in a first direction of the first layer, and is harder than the first layer. The third layer is disposed in a first direction of the second layer, and includes an electronic component electrically connected to the conductor. The wearable device 100 also includes a fourth layer and a fifth layer. The fourth layer is disposed in a second direction opposite to the first direction of the detection unit, and is waterproof. The fifth layer is disposed in a second direction of the fourth layer, and is water-absorbent. Note that the above descriptions "first" to "fifth" are used to distinguish each layer, and do not mean an order or the like.

[0075] The wearable device 100 also includes a conductive gel layer 132, an electrode layer (electrodes 111, 112, 113), an electronic component layer (electronic component section 120), a flexible layer (flexible substrate 110), a waterproof layer 133, and a water absorbing layer 134. The conductive gel layer 132 is capable of contacting the skin of the subject. The electrode layer has an electrode electrically connected to the conductive gel layer 132. The electronic component layer includes electronic components. The flexible layer has an electrode layer disposed on a first surface, an electronic component layer disposed on a second surface opposite to the first surface, and a conductor electrically connecting the electrode layer and the electronic component layer. The waterproof layer 133 is disposed on a surface of the conductive gel layer 132 opposite to the surface adjacent to the electrode layer. The water absorbing layer 134 is disposed on a surface of the waterproof layer 133 opposite to the surface adjacent to the conductive gel layer 132. This allows the wearable device 100 to stably acquire continuous biological information. For example, the wearable device 100 has a water-absorbing layer 134 that absorbs sweat and dissipates it to the outside of the wearable device 100, reducing the possibility that the hydrogel (conductive gel layer 132) absorbs moisture, expands, and peels off from adjacent layers. As a result, the wearable device 100 can stably acquire continuous biological information.

[0076] In other words, the wearable device 100 includes a first layer, a second layer, a conductive gel portion, an electrode portion, a third layer, and a fourth layer. The first layer has water absorbency. The second layer is disposed in a first direction of the first layer and has waterproof properties. The conductive gel portion is disposed in a first direction of the second layer and is capable of contacting the skin of a subject. The electrode portion is disposed in the first direction of the conductive gel portion and is electrically connected to the conductive gel portion. The third layer is disposed in the first direction of the electrode portion, has a conductor electrically connected to the electrode portion, and is flexible. The fourth layer is disposed in the first direction of the third layer and includes an electronic component electrically connected by the conductor. Note that the above descriptions "first" to "fourth" are used to distinguish each layer and do not mean an order or the like.

[0077] In other words, the wearable device 100 has a detection unit (electrode), a flexible substrate, a first plating layer, and a second plating layer. The flexible substrate is arranged in a first direction of the detection unit, has an electronic component electrically connected to the detection unit, and is flexible. The first plating layer is arranged in a second direction of the electrode unit and contains gold. The second plating layer is arranged in a second direction of the first plating layer and contains a metal other than gold. This allows the wearable device 100 to reduce ion migration, in which metal ions such as copper and nickel contained in the electrode unit are eluted into the conductive gel portion. This allows the wearable device 100 to reduce itching and rough skin caused by the elution of metal ions into the conductive gel portion, making it possible to stably acquire continuous biological information.

[0078] (Variation 1) In the above embodiment, the pores of the water absorption layer 134 are larger than the pores of the waterproof layer 133, but the embodiment is not limited to this. For example, the pores of the water absorption layer 134 may be the same size as the pores of the waterproof layer 133.

[0079] An example of the structure of the adhesive portion 130 according to Modification 1 will be described with reference to Fig. 7. Fig. 7 is a diagram showing an example of the structure of the adhesive portion 130 according to Modification 1. The upper part of Fig. 4 illustrates a front view of the adhesive portion 130. The lower part of Fig. 4 illustrates a bottom view of the adhesive portion 130.

[0080] 4, the holes in the water absorption layer 134 have a diameter of 15 mm, which is the same size as the holes in the waterproof layer 133. In this case, the ends (edges) of the holes in the water absorption layer 134 are close to the conductive gels 132A, 132B, and 132C, so there is a possibility that moisture absorbed by the water absorption layer 134 will pass through the ends of the holes and be absorbed by the conductive gels 132A, 132B, and 132C.

[0081] Therefore, the waterproof layer 133 has a thickness of 30 μm or more and less than 150 μm, and more preferably has a thickness of 75 μm or more and less than 120 μm. By making the waterproof layer 133 have a certain thickness or more, the ends (edges) of the holes in the water absorption layer 134 are spaced apart from the conductive gels 132A, 132B, and 132C, so that it is possible to reduce the possibility that moisture absorbed by the water absorption layer 134 will pass through the ends of the holes and be absorbed by the conductive gels 132A, 132B, and 132C. Furthermore, by making the thickness of the waterproof layer 133 less than a certain value, the wearable device 100 can easily follow the movement of the wearer, and therefore it is possible to acquire biological information more stably.

[0082] 7, the holes in skin adhesive layer 135 have a diameter of 15 mm, which is the same size as the holes in waterproof layer 133 and water absorbent layer 134. This allows the holes to be formed after waterproof layer 133, water absorbent layer 134, and skin adhesive layer 135 are stacked together, simplifying the manufacturing process.

[0083] (Variation 2) Further, the layer structure of the plating layer 150 is not limited to the layer structure of Fig. 5. Other layer structures will be described with reference to Fig. 8. Fig. 8 is a diagram showing an example of the layer structure of the plating layer 150 according to the second modification.

[0084] As shown in Fig. 8, plating layer 150 according to modification 2 is disposed above electrode 111 (second direction), and includes first plating layer 151 and second plating layer 154. Here, electrode 111 and first plating layer 151 shown in Fig. 8 are similar to electrode 111 and first plating layer 151 shown in Fig. 5, and therefore description thereof will be omitted.

[0085] The second plating layer 154 is disposed above the first plating layer 151 and is a layer containing silver (Ag). For example, the second plating layer 154 is a thin film (plating) formed of silver and has a thickness of 0.2 μm. The surface of the second plating layer 154 may be subjected to an anti-oxidation treatment to improve durability and scratch resistance.

[0086] The thickness of second plating layer 154 is, for example, preferably 1 nm or more and 10 μm, more preferably 1 nm or more and less than 1 μm, and particularly preferably 10 nm or more and less than 500 nm.

[0087] According to this, the plating layer 150 according to the second modification can reduce ion migration, in which metal ions contained in the electrode part are eluted into the conductive gel part. As a result, the plating layer 150 according to the second modification can reduce itching and rough skin caused by the elution of metal ions into the conductive gel part, making it possible to stably acquire continuous biological information.

[0088] (Other embodiments) In addition to the above-described embodiment, the present invention may be embodied in various different forms.

[0089] (Detection method) This embodiment can be provided as a detection method that includes detecting an abnormality (heart disease such as atrial fibrillation) of a subject based on biological information acquired using a wearable device 100. For example, the detection method detects an abnormality of a subject based on biological information for 72 hours or more. Furthermore, the longer the detection time, the more accurate the detection of the abnormality of the subject can be achieved, and it is preferable to detect an abnormality of a subject based on a detection time of preferably 120 hours or more, and more preferably 168 hours or more. Any known method can be applied as the method for detecting an abnormality based on biological information.

[0090] The above-described embodiment can be arbitrarily combined with the above-described modified examples, and the above-described modified examples may be arbitrarily combined with each other.

[0091] [Example] The present invention will be described in more detail below based on examples, but the present invention is not limited to these examples.

[0092] [Example A] Using Example A, durability against bending and discomfort in long-term use were examined. Based on the configurations described in the above-mentioned embodiments, wearable devices corresponding to Examples A1 to A7 and Comparative Examples A1 to A2 shown in Table 1 were created. Table 1 shows the device configurations and evaluation results of the wearable devices according to each of the examples and comparative examples.

[0093] [Table 1]

[0094] The examples in Table 1 were created by changing the device configuration of the wearable devices according to each of the Examples and Comparative Examples. The device configurations that were subject to change included four items: layer configuration, isolation layer area, isolation layer material, and isolation layer position.

[0095] The layer structure is the layer structure described in the above-mentioned embodiment. That is, the layer structure shown in Table 1 indicates whether or not each layer is present, from the side closest to the human body (skin), including the skin adhesive layer 135, the water absorbing layer 134, the waterproof layer 133, the conductive gel layer 132, the waterproof layer 131, the electrode layer (electrodes 111, 112, 113), the flexible layer (flexible substrate 110), the isolation layer (hard substrate 121), and the electronic component layer (electronic component section 120). In Table 1, a circle indicates that the layer is present, and a hysteresis indicates that the layer is not present.

[0096] As for the detailed configuration (material) of each layer, a layer containing an acrylic adhesive and a hydrocolloid was used as the skin adhesive layer 135, a nonwoven fabric made of polyurethane resin was used as the water absorbing layer 134, layers made of polyester resin were used as the waterproof layers 133 and 131, and a substrate made of polyimide resin and having a thickness of 0.18 mm was used as the flexible substrate 110. As in the electrode layer shown in Figs. 2 and 6, electrodes 111 and 112 were disposed at both ends in the longitudinal direction of the wearable device, and electrode 113 was disposed between the two electrodes at a position close to electrode 112. Electrodes 111 and 112 were used as the positive and negative electrodes, and electrode 113 was used as the reference electrode. The material of the isolation layer is described later in "Isolation Layer Material" in Table 1, and each has a thickness of 0.8 mm.

[0097] The isolation layer area indicates the ratio [%] of the isolation layer area to the flexible layer area. Note that a "-" sign indicates that no data is available (no isolation layer).

[0098] The isolation layer material indicates the material of the isolation layer. In the example of Table 1, the isolation layer material was selected from glass epoxy, paper phenol, and glass polyimide. Note that the "-" mark indicates that there is no corresponding data (no isolation layer).

[0099] The isolation layer position indicates the position of the isolation layer in the flexible layer. In the example of Table 1, the end or center was selected as the isolation layer position. Here, the end means either one of the two ends in the longitudinal direction of the wearable device, and is the position corresponding to electrode 111 or electrode 112. Also, the center means the position between electrodes 111 and 112, and does not correspond to electrode 113. Note that a "-" mark indicates that there is no corresponding data (no isolation layer).

[0100] As shown in Table 1, the wearable device of Example A1 has nine layers, including skin adhesive layer 135, water absorption layer 134, waterproof layer 133, conductive gel layer 132, waterproof layer 131, electrode layer, flexible layer, isolation layer, and electronic component layer. Moreover, the wearable device of Example A1 has an isolation layer area of ​​"35%", an isolation layer material of "glass epoxy", and an isolation layer position at the "end".

[0101] The wearable device of Example A2 has an isolation layer area of ​​15%. The layer structure, isolation layer material, and isolation layer position of the wearable device of Example A2 are the same as those of Example A1.

[0102] The wearable device of Example A3 has an isolation layer area of ​​45%. The layer configuration, isolation layer material, and isolation layer position of the wearable device of Example A3 are the same as those of Example A1.

[0103] In the wearable device of Example A4, the material of the isolation layer is "paper phenol." In addition, the layer structure, isolation layer area, and isolation layer position of the wearable device of Example A4 are the same as the layer structure, isolation layer area, and isolation layer position of Example A1.

[0104] In the wearable device of Example A5, the material of the isolation layer is "glass polyimide." In addition, the layer structure, isolation layer area, and isolation layer position of the wearable device of Example A5 are the same as the layer structure, isolation layer area, and isolation layer position of Example A1.

[0105] In the wearable device of Example A6, the position of the isolation layer is “center.” The layer configuration, isolation layer area, and isolation layer material of the wearable device of Example A6 are the same as those of Example A1.

[0106] The wearable device of Example A7 does not have water-absorbing layer 134 in its layer structure, but has eight layers, including skin adhesive layer 135, waterproof layer 133, conductive gel layer 132, waterproof layer 131, electrode layer, flexible layer, isolation layer, and electronic component layer. In addition, the isolation layer area, isolation layer material, and isolation layer position of the wearable device of Example A7 are the same as those of Example A1.

[0107] The wearable device of Comparative Example A1 does not have a water-absorbing layer 134 or an isolating layer in its layer configuration, but has seven layers: a skin adhesive layer 135, a waterproof layer 133, a conductive gel layer 132, a waterproof layer 131, an electrode layer, a flexible layer, and an electronic component layer. In addition, since the wearable device of Comparative Example A1 does not have an isolating layer, there is no relevant data for the area, material, and position of the isolating layer.

[0108] The wearable device of Comparative Example A2 does not have water absorption layer 134, waterproof layer 133, or isolation layer in its layer configuration, but has six layers: skin adhesive layer 135, conductive gel layer 132, waterproof layer 131, electrode layer, flexible layer, and electronic component layer. In addition, since the wearable device of Comparative Example A2 does not have an isolation layer, there is no relevant data for the isolation layer area, isolation layer material, and isolation layer position.

[0109] Next, evaluation of the wearable devices according to each of the examples and comparative examples will be described. The evaluation of the wearable devices according to each of the examples and comparative examples was performed in five items: bending test 1, bending test 2, data accuracy, waterproofness, and discomfort.

[0110] In the bending test 1, each wearable device is bent and straightened 100 times using a bending test device. Here, this test device is a device that can automatically repeat bending and straightening of a plate-shaped test object. The test device is equipped with two plate members with a variable relative angle as a base, and the test object is bent and straightened by fixing both ends of the test object to the two plate members. In this embodiment, both ends of the wearable device are fixed to the base with tape at 15 mm, and bending and straightening are repeatedly performed to a bending radius of 17 mm and a bending angle of 180°. After bending and straightening 100 times, each wearable device is used to evaluate the damage state. The damage state is evaluated in three stages: "A", "B", and "C". "A" indicates that the device can be used as before the test, that is, no damage is observed. "B" indicates that the wearable device worked, but some damage was observed in the acquired data. "C" indicates that the wearable device no longer works.

[0111] In the bending test 2, each wearable device was bent and straightened 1000 times using the test equipment used in the bending test 1. After bending and straightening 1000 times, each wearable device was used to evaluate the damage state. The evaluation criteria for the damage state were the same as those in the bending test 1, so the explanation is omitted.

[0112] Data accuracy was evaluated based on the accuracy of the data (electrocardiogram signals) obtained by using each wearable device for seven days, based on the lack of data loss and noise. Data accuracy was evaluated on a three-level scale: "A," "B," and "C." "A" indicates that there was no data loss or noise. "B" indicates that some data loss or noise was observed. "C" indicates that the wearable device was damaged and no data for the seven days could be obtained.

[0113] Waterproofing was evaluated based on the expansion rate of the conductive gel layer 132 after each wearable device was left for seven days in an environment with a temperature of 30 degrees and a humidity of 95%. The expansion rate was evaluated in two stages: "A" and "B." "A" indicates that the expansion rate is less than 20%. "B" indicates that the expansion rate is 20% or more.

[0114] Discomfort was assessed by the wearer's discomfort after wearing each wearable device for seven days. Discomfort was assessed on a three-point scale: "A," "B," and "C." "A" indicates that no particular discomfort was felt. "B" indicates that some itching was felt. "C" indicates that severe itching was felt. Note that the itching that occurred in the discomfort assessment was observed approximately 72 hours after wearing the device. Furthermore, severe itching was observed approximately 120 hours after wearing the device.

[0115] The wearable device of Example A1 was evaluated as "A" in five categories: bending test 1, bending test 2, data accuracy, waterproofness, and discomfort. The wearable device of Example A1 achieved the best results compared to the wearable devices of the other Examples and Comparative Examples.

[0116] The wearable device of Example A2 was evaluated as "B" in Bending Test 1 and Bending Test 2. This result suggests that the risk of disconnection can be reduced by making the isolation layer area larger than a certain size.

[0117] The wearable device of Example A3 was rated as "B" in terms of data accuracy and discomfort. This result suggests that by reducing the area of ​​the isolation layer, the shape of the wearable device can more easily follow the movement of the body, which may prevent peeling.

[0118] The wearable device of Example A4 was evaluated as "B" in the bending test 2. This result suggests that by making the isolating layer have a certain hardness (paper phenol) or more, bending of the isolating layer itself can be prevented, and the risk of breakage can be reduced.

[0119] The wearable device of Example A5 was rated as "B" in data accuracy and discomfort. This result suggests that by making the isolation layer have a certain hardness (glass polyimide) or less, the shape of the wearable device can easily follow the movement of the body, and peeling can be prevented.

[0120] The wearable device of Example A6 was evaluated as "B" in bending test 2, data accuracy, and discomfort. Here, when the isolation layer is in the center, the flexible layer bends at both ends of the isolation layer, so the number of bending points increases to two compared to when the isolation layer is at the end (one bending point). This result suggests that the risk of disconnection can be reduced by reducing the number of bending points. It also suggests that reducing the number of bending points makes it easier to follow the movement of the body and may prevent peeling.

[0121] The wearable device of Example A7 was rated as "B" in terms of discomfort. This result suggests that the presence of a water-absorbing layer may facilitate the dissipation of sweat to the outside of the wearable device, thereby reducing itching.

[0122] The wearable device of Comparative Example A1 was rated as "B" in the bending test 1 and discomfort, and was rated as "C" in the bending test 2. These results suggest that without an isolation layer, all of the important wiring of the device would be placed on the flexible layer, increasing the risk of disconnection. Also, without a water-absorbing layer, it would be difficult for sweat to dissipate outside the wearable device, which could lead to itching.

[0123] The wearable device of Comparative Example A2 was evaluated as "B" in the bending test 1, data accuracy, and waterproofness, and was evaluated as "C" in the bending test 2 and discomfort. This result suggests that without the isolation layer, all important wiring of the device is arranged on the flexible layer, increasing the risk of disconnection. It was also suggested that without the water absorption layer 134, sweat is less likely to dissipate to the outside of the wearable device, which may lead to itching. It was also suggested that without the water absorption layer 134 and the waterproof layer 133, much of the sweat generated on the skin contact surface of the wearable device is absorbed by the hydrogel (conductive gel layer 132), causing it to expand significantly, increasing the risk of peeling.

[0124] [Example B] Next, ion migration was examined using Example B. Based on the configuration described in Example A1 above, wearable devices corresponding to Examples B1 to B2 and Comparative Examples B1 to B4 shown in Table 2 were fabricated. Table 2 shows the plating configuration and evaluation results of the wearable devices according to each Example and Comparative Example.

[0125] [Table 2]

[0126] The examples in Table 2 were created by changing the layer configuration of the plating layer formed on the surface of the electrode part on the flexible substrate of the wearable device according to each of the examples and comparative examples. The layer configurations of the plating layer that were changed were the first plating layer, the second plating layer, and the third plating layer.

[0127] The layer structure of the plating layer corresponds to the layer structure described in the above embodiment. That is, the layer structure of the plating layer shown in Table 2 indicates whether or not each of the first plating layer, the second plating layer, and the third plating layer is present, in order from the side closer to the flexible substrate. In Table 2, the main components in the plating layer are represented as Au for gold, Pd for palladium, Ag for silver, and Ni for nickel. Also, a "-" mark indicates that the layer is not present.

[0128] As for the detailed configuration of the plating layers, in the first plating layer, the Au strike layer was 10 nm thick, and the Ni layer was 3 μm thick, and in the second plating layer and the third plating layer, the Pd layer was 100 nm thick, the Ag layer was 150 nm thick, and the Au layer was 100 nm thick.

[0129] The plating solution used to form the Au strike layer may be an electroless gold plating solution (e.g., Flash Gold NB (registered trademark) or Flash Gold V (registered trademark) manufactured by Okuno Chemical Industries Co., Ltd.), an electrolytic plating solution (e.g., Acid Strike (registered trademark) manufactured by Japan High Purity Chemical Co., Ltd.), or the like. Among these, it is preferable to form the Au strike layer using an electroless plating solution, since this allows for dense and uniform plating.

[0130] Although not shown in Table 2, each of the examples and comparative examples of Example B had the following configuration. That is, the detailed configuration (material) of the printed layer was a 10 μm thick layer made of silver and thermosetting resin as the first printed layer, and a 10 μm thick layer made of silver, silver chloride, and thermosetting resin as the second printed layer. As in the case of Figs. 2 and 5, the electrode layer had electrodes 111 and 112 arranged at both ends in the longitudinal direction of the wearable device, and electrode 113 arranged between the two electrodes at a position close to electrode 112. Electrodes 111 and 112 were set as a positive electrode and a negative electrode, and electrode 113 was set as a reference electrode.

[0131] Next, the evaluation of the wearable devices according to each of the examples and comparative examples will be described. The evaluation of the wearable devices according to each of the examples and comparative examples was performed on five items: the amount of copper (Cu) eluted, the amount of nickel (Ni) eluted, discomfort, appearance evaluation 1, and appearance evaluation 2.

[0132] The Cu and Ni elution test uses inductively coupled plasma atomic emission spectrometry (ICP-AES) to detect Cu and Ni eluted into the conductive gel attached to the wearable device. The wearable device was operated and the conductive gel was left attached for 7 days, after which the state of metal elution in the conductive gel was evaluated. The elution state was rated on a three-level scale: "A," "B," and "C." "A" indicates less than 100 ppm, meaning that almost no elution was observed. "B" indicates between 100 ppm and 300 ppm, meaning that some elution was observed in the acquired data. "C" indicates 300 ppm or more.

[0133] Appearance change 1 was evaluated by the discoloration of the conductive gel after wearing each wearable device for seven days. Appearance change 1 was evaluated on a three-level scale: "A," "B," and "C." "A" indicates that no discoloration was observed. "B" indicates that some discoloration occurred. "C" indicates that severe discoloration occurred.

[0134] Appearance change 2 was evaluated by observing the change in color of the conductive gel after wearing each wearable device 20 times for seven days. Appearance change 2 was evaluated using three levels: "A," "B," and "C." "A" indicates that no discoloration was observed. "B" indicates that some discoloration occurred. "C" indicates that severe discoloration occurred.

[0135] The wearable device of Example B1 was evaluated as "A" in four items: Cu elution amount, Ni elution amount, appearance change 1, and appearance change 2. The wearable device of Example B1 achieved the best results compared to the wearable devices of the other Examples and Comparative Examples.

[0136] For the wearable device of Example B2, the Cu elution amount, Ni elution amount, and appearance change 1 were evaluated as "A," and the appearance change 2 was evaluated as "B." From these results, when silver was used as the second plating layer and no third plating layer was provided, some discoloration of the conductive gel was observed after long-term use, but the other evaluation items were evaluated as equivalent to Example B1.

[0137] The wearable device of Comparative Example B1 was evaluated as "A" for the amount of Ni elution, "B" for appearance change 1, and "C" for the amount of Cu elution and appearance change 2. From these results, when only the gold strike layer was used as the plating layer, elution of 100 ppm or more of Cu was observed, and some itching and discoloration of the conductive gel were observed.

[0138] The wearable device of Comparative Example B2 was evaluated as "B" for the amount of Ni elution and appearance change 1, and as "C" for the amount of Cu elution and appearance change 2. From these results, when the gold strike layer was not used as the first plating layer, and the other three plating layers were used, elution of 100 ppm or more of Cu and Ni was observed, and some itching and discoloration of the conductive gel were observed.

[0139] The wearable device of Comparative Example B3 was evaluated as "C" in four categories: Cu elution amount, Ni elution amount, appearance change 1, and appearance change 2. The wearable device of Comparative Example B3 had the worst results compared to the wearable devices of the other Examples and Comparative Examples.

[0140] The wearable device of Comparative Example B4 was evaluated as "C" in four categories, namely, Cu elution amount, appearance change 1, and appearance change 2, and was evaluated as "A" in the amount of Ni elution. From this result, the wearable device of Comparative Example B4 had the second worst result after the wearable device of Comparative Example B3, although the amount of Ni elution was less than 100 ppm.

[0141] As described above, Example B confirmed the effectiveness of providing a gold strike plating layer on the surface of the electrode portion, and of providing a plating layer containing a metal other than gold on the surface of the gold strike. [Explanation of symbols]

[0142] 100 Wearable Devices 110 Flexible PCB 111,112,113 electrode 120 Electronic Components Department 121 Hard substrate 130 Adhesive part 131,133 waterproof layer 132 Conductive gel layer 134 Water absorption layer 135 Skin adhesive layer 140 Lead Wire 150 plating layer 151 First plating layer 152 Second plating layer 153 3rd plating layer

Claims

1. A wearable device that acquires biological information of a subject, A detection unit that detects an electrocardiogram signal as the biological information; a flexible substrate having electronic components electrically connected to the detection unit and disposed in a first direction that is a direction away from the subject in the detection unit; and a waterproof layer disposed in a second direction opposite to the first direction of the detection unit and having waterproof properties; a water-absorbing layer disposed in the second direction of the waterproof layer and having water-absorbing properties; The detection unit is an electrode portion having an electrode electrically connected to the electronic component; a first plating layer including gold and disposed in the second direction of the electrode portion; a second plating layer disposed in the second direction of the first plating layer and including palladium, silver, chromium, zinc, rhodium, or platinum; a conductive gel portion that can come into contact with the subject's skin and is electrically connected to the electrode; having The flexible substrate comprises: A conductor electrically connected to the detection unit; a rigid substrate disposed in the first direction of the flexible substrate and being harder than the flexible substrate; the electronic component is disposed in the first direction of the rigid substrate and is electrically connected to the conductor; Wearable devices.

2. The waterproof layer and the water absorbing layer have an opening for contacting the conductive gel portion with the skin of the subject. The wearable device of claim 1 .

3. The opening of the water absorption layer is larger than the opening of the waterproof layer. The wearable device of claim 2 .

4. The water absorption layer is a layer including a nonwoven fabric. The wearable device according to any one of claims 1 to 3.

5. The rigid substrate is disposed on an end of the flexible substrate. The wearable device according to any one of claims 2 to 4.

6. The hard substrate is disposed at a position corresponding to the electrode of the flexible substrate. The wearable device according to any one of claims 2 to 4.

7. The second plating layer includes palladium. A wearable device according to any one of claims 1 to 6.

8. a third plating layer disposed in the second direction of the second plating layer and including gold; A wearable device according to any one of claims 1 to 7.

9. The thickness of the first plating layer is 0.1 nm or more and less than 1 μm. A wearable device according to any one of claims 1 to 8.

10. The thickness of the second plating layer is 1 nm or more and less than 10 μm. A wearable device according to any one of claims 1 to 9.

11. The thickness of the third plating layer is 1 nm or more and less than 10 μm. The wearable device of claim 8 .

12. the first direction corresponds to a direction in which the wearable device is moved away from the skin when the wearable device is attached to the skin of the subject. A wearable device according to any one of claims 1 to 11.

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