Wearable Devices

Abstract

The present invention addresses the problem of providing a wearable device and a detection method with which it is possible to stably acquire continuous biological information.　A wearable device according to an embodiment of the present invention includes a detecting unit, a first layer, a second layer, and a third layer. The detecting unit detects the biological information. The first layer is disposed in a first direction with respect to the detecting unit, has a conductor electrically connected to the detecting unit, and has flexibility. The second layer is disposed in the first direction with respect to the first layer and is harder than the first layer. The third layer is disposed in the first direction with respect to the second layer and includes an electronic component electrically connected to the conductor.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION Embodiments of the present invention relate 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 continuously acquire electrocardiogram signals. It is expected that such wearable devices will be able to acquire continuous biometric information in everyday life. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 6539827 specification Summary of the Invention [Problem to be solved by the invention]

[0004] However, wearable devices may be unable to acquire biometric information due to various factors in daily life. For example, wearable devices may bend and break due to human body movement. Furthermore, sweat (moisture) may cause discomfort to the wearer or the device may peel off from the wearer's skin. Therefore, an object of the present invention is to provide a wearable device and a detection method that can stably acquire 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; a flexible first layer arranged in a first direction of the detection unit, having a conductor electrically connected to the detection unit; a second layer arranged in the first direction of the first layer, being harder than the first layer; and a third layer arranged in the first direction of the second layer, including an electronic component electrically connected to the conductor.

[0006] The present invention also provides a wearable device for acquiring biometric information of a subject, comprising: a first layer that is water-absorbent; a second layer that is waterproof and arranged in a first direction of the first layer; a conductive gel portion that is contactable with the skin of the subject and arranged in the first direction of the second layer; an electrode portion that is arranged in the first direction of the conductive gel portion and has an electrode electrically connected to the conductive gel portion; a flexible third layer that is arranged in the first direction of the electrode portion and has a conductor electrically connected to the electrode portion; and a fourth layer that is arranged in the first direction of the third layer and includes electronic components electrically connected by the conductor.

[0007] 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. [Effects of the Invention]

[0008] According to the present invention, it is possible to provide a wearable device and a detection method that are capable of stably acquiring continuous biological information. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a diagram showing an example of the structure of a wearable device 100 according to an embodiment. [Figure 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. [Figure 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. [Figure 5] FIG. 5 is a diagram for explaining a method for attaching the wearable device 100 according to the embodiment. [Figure 6] FIG. 6 is a diagram showing an example of the structure of the adhesive portion 130 according to a modified example. DETAILED DESCRIPTION OF THE INVENTION

[0010] 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 no contradiction occurs in the configuration. Furthermore, the embodiment described below can include the configuration described in Japanese Patent No. 6539827.

[0011] Note that the configurations illustrated below are not limited to the illustrated contents. For example, the dimensions and angles of the components illustrated below can be changed as appropriate within the scope that does not impair the functionality of the wearable device.

[0012] (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.

[0013] The wearable device 100 is a device (sensor device) that acquires biometric information of a subject. For example, the wearable device 100 is formed in a substantially rectangular (strip-like) shape and is used by being attached to the subject's skin. The subject is a person from whom biometric information is acquired, and corresponds to a person who wears the wearable device 100 (wearer). The term "substantially rectangular" refers not only to a rectangle having four corners (vertices) and opposite sides that are parallel to each other, but also to a shape with four rounded corners or a shape with each side having a slight curvature, as shown in FIG. 1.

[0014] For example, the wearable device 100 detects an electrocardiogram signal as biometric information. Note that, although the following description will be given of the wearable device 100 acquiring an electrocardiogram signal, the embodiment is not limited to this. For example, the wearable device 100 may be a sensor device that acquires biometric information 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 biometric information, but can also acquire multiple types of biometric information.

[0015] 1, the wearable device 100 includes a flexible substrate 110, an electronic component section 120, and an adhesive section 130. The flexible substrate 110, the electronic component section 120, and the adhesive section 130 will be described in detail later.

[0016] Note that the content described in FIG. 1 is merely an example and is not limited to the illustrated content. For example, FIG. 1 illustrates an example in which the wearable device 100 is substantially rectangular, but the embodiment is not limited to this. The wearable device 100 can be formed into any shape, such as a square, a circle, or an ellipse. Among these shapes, a substantially rectangular or elliptical shape is preferable for the wearable device 100, and a substantially rectangular or elliptical shape with an aspect ratio (ratio of the major axis to the minor axis) of 1.1 or more is particularly preferable. A wearable device 100 of this shape allows for a wider inter-electrode distance within the same area, making it possible to acquire continuous biometric information with higher sensitivity. Furthermore, it is desirable that the end shape of the wearable device 100 is not angular. This shape makes it less likely to peel off from the subject's skin and does not cause discomfort.

[0017] In addition, in this embodiment, when the wearable device 100 is attached to the skin of a subject, the direction away from the skin may be described as "up." "Up" is an example of a first direction. Furthermore, the direction opposite to "up" may be described as "down." "Down" is an example of a second direction.

[0018] An example of the structure of the flexible substrate 110 and the electronic component section 120 according to the embodiment will be described using 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.

[0019] The flexible substrate 110 is a substrate on which conductors are wired and has flexibility so that it can flexibly follow the movements of the person wearing the wearable device 100. The flexible substrate 110 is, for example, a flexible printed circuit (FPC) 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, or 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 including the flexible substrate 110 is also called a "flexible layer."

[0020] 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 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, thereby enabling more stable acquisition of biological information.

[0021] 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.

[0022] 2, the case where there are three electrodes for detecting electrocardiographic signals is described, but the embodiment is not limited to this. The number of electrodes for detecting electrocardiographic signals can be set as needed.

[0023] The electronic component unit 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 unit 120 controls the supply of power to each unit in the wearable device 100, the amplification and collection of electrocardiogram signals detected by the electrodes 111, 112, and 113, and the output of the collected electrocardiogram signals. The layer having the electronic component unit 120 is also called the "electronic component layer."

[0024] Here, the electronic component unit 120 is laminated on a hard substrate 121. The hard substrate 121 is laminated on the flexible substrate 110 and supports the electronic component unit 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 these hard substrates, a paper epoxy substrate, a glass epoxy substrate, or a glass polyimide substrate is preferred, with a glass epoxy substrate being particularly preferred. 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 can easily support the electronic component unit 120, thereby enabling more stable acquisition of biometric information.

[0025] By being stacked on the hard substrate 121, the electronic component unit 120 has improved durability against bending (bending) compared to when it is stacked 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 loose and breaking due to bending, and it becomes possible to continuously and stably acquire biological information.

[0026] Furthermore, the hard substrate 121 is disposed at the end of the flexible substrate 110. This reduces the number of wires on the flexible substrate 110 to just a few wires directed toward the electronic component section 120 (hard substrate 121), thereby 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.

[0027] 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 electrode 112 and the like robust against bending. As a result, the wearable device 100 reduces the risk of damage to the electrode 112 and the like due to bending, and therefore becomes able to continuously and stably acquire biological information.

[0028] 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 section 120 is more easily supported, making it possible to acquire biometric information more stably. Note that the area of ​​the hard substrate 121 is the area of ​​the surface of the hard substrate 121 that faces the flexible substrate 110. Furthermore, the area of ​​the flexible substrate 110 is the area of ​​the surface of the flexible substrate 110 that faces the hard substrate 121.

[0029] Note that the content described in FIG. 2 is merely an example and is not limited to the content shown in the drawing. For example, FIG. 2 describes a case where electronic component unit 120 is stacked on hard substrate 121, but the embodiment is not limited to this. Electronic component unit 120 can be stacked on any member as long as it is a member that is harder (less flexible) than flexible substrate 110. In other words, electronic component unit 120 is stacked on an "isolation layer" that isolates flexible substrate 110 from bending. As the isolation layer, for example, a flexible substrate made of a material harder than flexible substrate 110 or a flexible substrate that is thicker than flexible substrate 110 can be used as desired. Note that the isolation layer is also called a "support layer" that supports electronic component unit 120.

[0030] 2 are not limited to the materials described above. For example, any known material can be used for the flexible substrate 110, electrodes 111, 112, and 113, electronic component part 120, and hard substrate 121 as long as the function of each of the above-described parts is not impaired.

[0031] An example of wiring on the flexible substrate 110 and the rigid substrate 121 according to the embodiment will be described using 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. These 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 to this. 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 arranged on the upper surface of the flexible substrate 110. Furthermore, through holes are formed at positions 110A, 110B, and 110C on 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 lead wires 140 on the rigid substrate 121 while remaining insulated.

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

[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 them at as few points as possible.

[0036] An example of the structure of the adhesive portion 130 according to the embodiment will be described using 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 adhesive strength 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 that has waterproof and insulating properties. For example, the waterproof layer 131 includes a material with excellent waterproof properties, such as polyester resin, polyurethane resin, polyethylene resin, polypropylene resin, or nylon resin. The waterproof layer 131 has holes for contacting the electrodes 111, 112, and 113 with the conductive gels 132A, 132B, and 132C, which will be described later. In the example of FIG. 4, the waterproof layer 131 has a circular hole with 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 skin of the subject, 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 (a water-containing gel) having 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, and 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. Furthermore, if any arbitrary member is placed therein, it is preferable to place a member that has 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 that has waterproof and insulating properties. For example, the waterproof layer 133 includes a material with excellent waterproof properties, such as polyester resin, polyurethane resin, or nylon resin. The waterproof layer 133 has holes for allowing each of the conductive gels 132A, 132B, and 132C to come into contact with the subject's skin. In the example of FIG. 4, the waterproof layer 133 has a circular hole with 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 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 water-absorbent layer. For example, the water absorption layer 134 includes a nonwoven fabric. Note that the water absorption layer 134 is not limited to a nonwoven fabric, and may be made of, for example, a water-absorbent fiber. Materials such as polyester resin, polyurethane resin, polypropylene resin, and nylon resin are preferably used as such fibers, and polyurethane resin or polypropylene resin is particularly preferred. Fibers made of such materials have excellent breathability and elasticity, making it easier for the effects of the water absorption layer 134, described below, to be exerted. The bottom surface of the waterproof layer 133 corresponds to the surface of the waterproof layer 133 opposite the surface adjacent to the conductive gel layer 132.

[0044] The water absorption layer 134 has holes for allowing each of the conductive gels 132A, 132B, and 132C to come into contact with the subject's skin. In the example of Fig. 4, the water absorption layer 134 has circular holes with a diameter of 22 mm.

[0045] The water absorption layer 134 has the function of absorbing sweat (moisture) produced on the wearer's skin 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. Furthermore, by preventing the expansion of the hydrogel, the water absorption layer 134 reduces the possibility of the hydrogel peeling 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 worn 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] Furthermore, 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 adhere to the subject's skin. 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 subject's skin. 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 also change. 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 portion 130 may have an adhesive layer for adhering each layer in addition to the five layers described above. The adhesive layer may be formed of any adhesive, such as a liquid or sheet. However, if each of the above layers has an adhesive function to adjacent layers, the adhesive layer may be omitted. For example, if the skin adhesive layer 135 has an adhesive function to the water absorption layer 134, the adhesive layer may be omitted between the water absorption layer 134 and the skin adhesive layer 135. Furthermore, if the waterproof layer 133 has an adhesive function to 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 materials described above. For example, any known material can be used as the material for waterproof layer 131, conductive gel layer 132, waterproof layer 133, water-absorbing layer 134, and skin-adhesive layer 135, as long as the function of each of the above-mentioned parts is not impaired.

[0052] A method for attaching the wearable device 100 according to the embodiment will be described with reference to Fig. 5. Fig. 5 is a diagram for explaining a method for attaching the wearable device 100 according to the embodiment.

[0053] For example, the wearable device 100 is distributed in a state where the flexible substrate 110, the electronic component unit 120, and the adhesive unit 130 are integrated together. That is, as shown in Fig. 5, the flexible substrate 110 and the electronic component unit 120 are pre-attached to the upper surface of the adhesive unit 130. 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.

[0054] Although not shown in FIG. 5 , 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. The user then attaches the bottom surface of the skin adhesive layer 135 to any position on the subject's skin. The bottom surface of the adhesive portion 130 corresponds to the bottom surface of the skin adhesive layer 135, that is, 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 a medical professional such as a doctor, the subject, or someone who provides medical or daily support to the subject.

[0055] 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).

[0056] Note that the content described in Fig. 5 is merely an example and is not limited to the illustrated content. For example, Fig. 5 describes a typical example in which the flexible substrate 110, the electronic component part 120, and the adhesive part 130 are distributed as an integrated unit, but the embodiment is not limited to this. For example, each part included in the wearable device 100 may be manufactured and distributed by an individual vendor.

[0057] 5, for convenience of illustration, each layer is shown as having the same thickness, but the thickness of each layer can be set arbitrarily. Furthermore, 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 pores of skin adhesive layer 135, water absorption layer 134, and waterproof layer 133, so when wearable device 100 is attached to the skin of a subject, conductive gel layer 132 easily comes into contact with the subject's skin.

[0058] 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 point-like 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 sections."

[0059] In the above embodiment, the layer having the three conductive gels 132A, 132B, and 132C is described as a "conductive gel layer." However, since the conductive gels 132A, 132B, and 132C are small and present in a dot-like manner compared to the flexible layer and the isolation layer, 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."

[0060] 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 stacked on the flexible layer and is harder than the flexible layer. The electronic component layer is stacked 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, the wearable device 100 has an isolation layer that isolates the electronic component layer from bending of the flexible layer, thereby reducing the risk of damage to the electronic component layer due to bending, making it possible to stably acquire continuous biometric information.

[0061] 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 terms "first" to "fifth" above are used to distinguish between the layers and do not indicate an order or the like.

[0062] The wearable device 100 also includes a conductive gel layer 132, an electrode layer (electrodes 111, 112, and 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 thereof, an electronic component layer disposed on a second surface opposite the first surface thereof, 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, which reduces the possibility that the hydrogel (conductive gel layer 132) will absorb moisture, expand, and peel off from adjacent layers. As a result, the wearable device 100 can stably acquire continuous biological information.

[0063] In other words, the wearable device 100 comprises a first layer, a second layer, a conductive gel portion, an electrode portion, a third layer, and a fourth layer. The first layer is water-absorbent. The second layer is disposed in a first direction of the first layer and is waterproof. The conductive gel portion is disposed in a first direction of the second layer and is contactable with the subject's skin. 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 terms "first" to "fourth" above are used to distinguish between the layers and do not indicate an order or the like.

[0064] (Variation) 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.

[0065] An example of the structure of the adhesive portion 130 according to a modified example will be described using Fig. 6. Fig. 6 is a diagram showing an example of the structure of the adhesive portion 130 according to a modified example. 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.

[0066] 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 into the conductive gels 132A, 132B, and 132C.

[0067] Therefore, the waterproof layer 133 has a thickness of 30 μm or more and less than 150 μm, and more preferably a thickness of 75 μm or more and less than 120 μm. By providing the waterproof layer 133 with 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, thereby reducing the possibility that moisture absorbed by the water absorption layer 134 will be absorbed by the conductive gels 132A, 132B, and 132C through the ends of the holes. Furthermore, by providing the waterproof layer 133 with a thickness less than a certain amount, the wearable device 100 can more easily follow the movements of the wearer, thereby enabling more stable acquisition of biological information.

[0068] 6, 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, thereby simplifying the manufacturing process.

[0069] (Other embodiments) In addition to the above-described embodiments, the present invention may be implemented in various different forms.

[0070] (Detection method) This embodiment can be provided as a detection method that includes detecting an abnormality (heart disease such as atrial fibrillation) in a subject based on biological information acquired using a wearable device 100. For example, the detection method detects an abnormality in a subject based on biological information from 72 hours or more. Furthermore, the longer the detection time, the more accurately the subject's abnormality can be detected, and it is preferable to detect an abnormality in a subject based on a detection time of preferably 120 hours or more, and more preferably 168 hours or more. Note that any known method can be applied as the method for detecting an abnormality based on biological information.

[0071] 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.

[0072] [Example] The present invention will be described in more detail below based on examples, but the present invention is not limited to these examples.

[0073] Based on the configurations described in the above-described embodiments, wearable devices corresponding to Examples 1 to 7 and Comparative Examples 1 and 2 shown in Table 1 were created. Table 1 shows the device configurations and evaluation results of the wearable devices according to each Example and Comparative Example.

[0074] [Table 1]

[0075] The examples in Table 1 were created by changing the device configuration of the wearable devices according to each example and comparative example. The device configurations that were changed included four items: layer configuration, isolation layer area, isolation layer material, and isolation layer position.

[0076] The layer configuration is the same as that described in the above-mentioned embodiment. That is, the layer configuration shown in Table 1 indicates whether or not each of the following layers is present, in order from the side closest to the human body (skin): skin adhesive layer 135, water absorption layer 134, waterproof layer 133, conductive gel layer 132, waterproof layer 131, electrode layer (electrodes 111, 112, 113), flexible layer (flexible substrate 110), isolation layer (hard substrate 121), and electronic component layer (electronic component section 120). In Table 1, a "○" indicates that the corresponding layer is present, and a "-" indicates that the corresponding layer is not present.

[0077] The detailed structure (materials) of each layer include: skin adhesive layer 135, a layer containing acrylic adhesive and hydrocolloid; water-absorbing layer 134, a nonwoven fabric made of polyurethane resin; waterproof layers 133 and 131, layers made of polyester resin; and flexible substrate 110, a 0.18 mm thick substrate made of polyimide resin. As in Figures 2 and 5, the electrode layer had electrodes 111 and 112 positioned at both ends of the wearable device in the longitudinal direction, with electrode 113 positioned between these two electrodes, closer to electrode 112. Electrodes 111 and 112 were used as the positive and negative electrodes, respectively, and electrode 113 was used as the reference electrode. The materials of the isolation layers are described below under "Isolation Layer Materials" in Table 1, and each had a thickness of 0.8 mm.

[0078] The isolation layer area indicates the ratio [%] of the isolation layer area to the flexible layer area. Note that a "-" sign indicates that there is no applicable data (no isolation layer).

[0079] 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 "-" symbol indicates that there is no corresponding data (no isolation layer).

[0080] The isolation layer position indicates the position of the isolation layer in the flexible layer. In the example of Table 1, either the end or the center was selected as the isolation layer position. Here, the end refers to either one of the two longitudinal ends of the wearable device, and is the position corresponding to electrode 111 or electrode 112. The center refers to the position between electrodes 111 and 112, and is not the position corresponding to electrode 113. Note that a "-" sign indicates that there is no corresponding data (no isolation layer).

[0081] As shown in Table 1, the wearable device of Example 1 has nine layers: 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. Furthermore, the wearable device of Example 1 has an isolation layer area of ​​"35%", an isolation layer material of "glass epoxy", and an isolation layer position at the "end".

[0082] The wearable device of Example 2 has an isolation layer area of ​​15%. The layer structure, isolation layer material, and isolation layer position of the wearable device of Example 2 are the same as the layer structure, isolation layer material, and isolation layer position of Example 1.

[0083] The wearable device of Example 3 has an isolation layer area of ​​45%. The layer structure, isolation layer material, and isolation layer position of the wearable device of Example 3 are the same as the layer structure, isolation layer material, and isolation layer position of Example 1.

[0084] The wearable device of Example 4 has an isolation layer made of "paper phenol." The layer structure, isolation layer area, and isolation layer position of the wearable device of Example 4 are the same as those of Example 1.

[0085] The material of the isolation layer of the wearable device of Example 5 is "glass polyimide." The layer structure, isolation layer area, and isolation layer position of the wearable device of Example 5 are the same as those of Example 1.

[0086] The wearable device of Example 6 has an isolation layer positioned at the "center." The layer configuration, isolation layer area, and isolation layer material of the wearable device of Example 6 are the same as those of Example 1.

[0087] The wearable device of Example 7 does not have a water-absorbing layer 134 in its layer configuration, but has eight 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, an isolation layer, and an electronic component layer. The isolation layer area, isolation layer material, and isolation layer position of the wearable device of Example 7 are the same as those of Example 1.

[0088] The wearable device of Comparative Example 1 does not have a water-absorbing layer 134 or an isolation 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. Furthermore, since the wearable device of Comparative Example 1 does not have an isolation layer, there is no relevant data for the isolation layer area, isolation layer material, and isolation layer position.

[0089] The wearable device of Comparative Example 2 does not have a water-absorbing layer 134, a waterproof layer 133, or an isolation layer in its layer configuration, but has six layers: a skin-adhesive layer 135, a conductive gel layer 132, a waterproof layer 131, an electrode layer, a flexible layer, and an electronic component layer. Furthermore, since the wearable device of Comparative Example 2 does not have an isolation layer, there is no relevant data for the isolation layer area, isolation layer material, and isolation layer position.

[0090] Next, the evaluation of the wearable devices according to each example and comparative example will be described. The evaluation of the wearable devices according to each example and comparative example was carried out in five categories: bending test 1, bending test 2, data accuracy, waterproofness, and discomfort.

[0091] In Bending Test 1, each wearable device was bent and stretched 100 times using a bending test device. This test device was capable of automatically and repeatedly bending and stretching a plate-shaped test object. The test device had two plate members with variable relative angles as bases. The test object was bent and stretched by fixing both ends of the test object to these two plate members. In this example, both ends of the wearable device were fixed to the base with tape at 15 mm. Repeated bending and stretching were performed to a bending radius of 17 mm and a bending angle of 180°. After 100 bending and stretching cycles, each wearable device was evaluated for damage. The damage was rated on a three-point scale: "A," "B," and "C." "A" indicates that the device was usable as before the test, i.e., no damage was observed. "B" indicates that the wearable device functioned but some loss of acquired data was observed. "C" indicates that the wearable device no longer functioned.

[0092] Bending test 2 was a test in which each wearable device was bent and stretched 1000 times using the testing equipment used in bending test 1. After 1000 bending and stretching cycles, each wearable device was used to evaluate the state of damage. The evaluation criteria for the state of damage were the same as those in bending test 1, so explanation is omitted here.

[0093] Data accuracy was evaluated based on the accuracy of the data (electrocardiogram signals) obtained using each wearable device for seven days, based on the lack of data loss and noise. Data accuracy was evaluated on a three-point scale: "A," "B," and "C." "A" indicates that no data loss or noise was observed. "B" indicates that some data loss or noise was observed. "C" indicates that the wearable device was damaged and data for seven days could not be obtained.

[0094] Waterproofing was evaluated based on the expansion rate of the conductive gel layer 132 after leaving each wearable device in an environment with a temperature of 30°C and humidity of 95% for seven days. The expansion rate was evaluated on a two-level scale: "A" and "B." "A" indicates an expansion rate of less than 20%. "B" indicates an expansion rate of 20% or more.

[0095] Discomfort was assessed by assessing the discomfort experienced by the wearer after wearing each wearable device for seven days. Discomfort was assessed on a three-point scale: "A," "B," and "C." "A" indicates no particular discomfort. "B" indicates some itching. "C" indicates severe itching. Note that the itching experienced in the discomfort assessment was observed approximately 72 hours after wearing the device. Severe itching was observed approximately 120 hours after wearing the device.

[0096] The wearable device of Example 1 obtained an evaluation result of "A" in five categories: Bending Test 1, Bending Test 2, Data Accuracy, Waterproofing, and Discomfort. The wearable device of Example 1 achieved the best results compared to the wearable devices of the other Examples and Comparative Examples.

[0097] The wearable device of Example 2 obtained an evaluation result of "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.

[0098] The wearable device of Example 3 was rated "B" for data accuracy and discomfort. This result suggests that reducing the area of ​​the isolation layer may enable the shape of the wearable device to more easily follow the movement of the body, preventing peeling.

[0099] The wearable device of Example 4 obtained an evaluation result of "B" in Bending Test 2. This result suggests that by making the isolating layer hard enough (paper phenol) or more, it is possible to prevent the isolating layer itself from bending and reduce the risk of breakage.

[0100] The wearable device of Example 5 was rated "B" for data accuracy and discomfort. This result suggests that by making the isolation layer at a certain hardness (glass polyimide) or less, the shape of the wearable device can more easily follow the movement of the body, potentially preventing peeling.

[0101] The wearable device of Example 6 received a rating of "B" in Bending Test 2, data accuracy, and discomfort. When the isolation layer is located in the center, the flexible layer bends at both ends of the isolation layer, resulting in two bending points compared to when the isolation layer is located at the ends (one bending point). This result suggests that reducing the number of bending points can reduce the risk of breakage. It also suggests that reducing the number of bending points can make the device more likely to follow the movements of the body, potentially preventing peeling.

[0102] The wearable device of Example 7 was rated as "B" for discomfort. This result suggests that the presence of a water-absorbing layer may facilitate the evaporation of sweat to the outside of the wearable device, potentially reducing itching.

[0103] The wearable device of Comparative Example 1 received a rating of "B" in Bending Test 1 and discomfort, and a rating of "C" in Bending Test 2. These results suggest that without an isolation layer, all of the device's important wiring would be placed on the flexible layer, increasing the risk of wire breakage. Furthermore, without a water-absorbing layer, it becomes difficult for sweat to escape from the wearable device, potentially leading to itching.

[0104] The wearable device of Comparative Example 2 received a rating of "B" in Bending Test 1, data accuracy, and waterproofing, and a rating of "C" in Bending Test 2 and discomfort. These results suggest that without the isolation layer, all of the device's important wiring would be located on the flexible layer, increasing the risk of disconnection. Furthermore, without the water-absorbing layer 134, sweat would be less likely to evaporate to the outside of the wearable device, potentially leading to itching. Furthermore, without the water-absorbing layer 134 and waterproof layer 133, much of the sweat generated on the skin-adhering surface of the wearable device 100 would be absorbed by the hydrogel (conductive gel layer 132), causing it to expand significantly, increasing the risk of peeling. [Explanation of symbols]

[0105] 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

Claims

1. A wearable device that acquires biological information of a subject, a detection unit that detects the biological information; a first layer that is disposed in a first direction of the detection portion, has a conductor electrically connected to the detection portion, and is flexible; a second layer disposed in the first direction of the first layer and harder than the first layer; a third layer including electronic components arranged in the first direction of the second layer and electrically connected to the conductor; Equipped with a surface of the second layer facing a second direction opposite to the first direction, the surface including at least an area corresponding to an area where the electronic component is to be disposed, is in contact with the first layer; Wearable devices.

2. The detection unit an electrode portion having an electrode electrically connected to the conductor; a conductive gel portion that can come into contact with the subject's skin and is electrically connected to the electrode; detecting an electrocardiogram signal as the biological information; The wearable device of claim 1 .

3. a fourth layer that is disposed in a second direction opposite to the first direction of the detection unit and has waterproof properties; a fifth layer disposed in the second direction of the fourth layer and having water absorption properties; and Further comprising: The wearable device of claim 2 .

4. the fourth layer and the fifth layer have openings for contacting the conductive gel portion with the subject's skin; The wearable device of claim 3 .

5. the opening in the fifth layer is larger than the opening in the fourth layer; The wearable device of claim 4 .

6. The fifth layer is a layer including a nonwoven fabric. The wearable device according to any one of claims 3 to 5.

7. The fourth layer has a thickness of 30 μm or more and less than 150 μm. The wearable device according to any one of claims 3 to 6.

8. The fourth layer has a thickness of 75 μm or more and less than 120 μm. The wearable device of claim 7 .

9. The area of ​​the second layer is 5 to 50% of the area of ​​the first layer. The wearable device according to claim 1 or 2.

10. The area of ​​the second layer is 15 to 45% of the area of ​​the first layer. The wearable device of claim 9 .

11. The second layer is disposed on an end of the first layer. The wearable device according to any one of claims 1 to 10.

12. the second layer is disposed at a position corresponding to the electrode of the first layer; The wearable device according to any one of claims 2 to 8.

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

14. the second layer is one of a paper epoxy substrate, a glass epoxy substrate, and a glass polyimide substrate; The wearable device according to any one of claims 1 to 13.

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