Device for collecting biological sample

Abstract

This device for collecting a biological sample from a living body includes a first adhesive layer in which an introduction port for a biological sample is formed in a part of a sticking surface to a living body, and a moisture-permeable waterproof base material in which a flow path for allowing the biological sample to flow into the device from the introduction port is formed and which is laminated on the first adhesive layer, wherein: he flow path is surrounded by a moisture-permeable waterproof material; one surface of a first waterproof base material is adhered to a sticking surface-facing surface of the first adhesive layer; one surface of the moisture-permeable waterproof base material is adhered via a second adhesive layer to the other surface of the first waterproof base material; and one surface of a second waterproof base material is adhered via a third adhesive layer to the other surface of the moisture-permeable waterproof base material; and the flow path is formed by a space formed in the moisture-permeable waterproof base material.

Description

Device for collecting biological samples

[0001] The present invention relates to a device for collecting biological samples.

[0002] Conventionally, a liquid collection device has been known that has a capillary-shaped micro-channel with a first opening at one end of the micro-channel and a second opening at the other end, and that collects a biological sample.

[0003] Japanese Patent Application Laid-Open No. 2021-01762

[0004] In the conventional technology described above, openings are formed at both ends of the flow channel, so there is a possibility that other liquids may become mixed into the biological sample collected in the flow channel.

[0005] The disclosed technology aims to prevent other liquids from contaminating the collected biological sample.

[0006] The disclosed technology is a device for collecting a biological sample from a living organism, comprising: a first adhesive layer having an inlet for the biological sample formed in a part of its surface to be attached to the living organism; and a breathable waterproof substrate laminated to the first adhesive layer, the breathable waterproof substrate having a flow path formed therein for allowing the biological sample to flow from the inlet into the device, the flow path being surrounded by a breathable waterproof material; one side of the first waterproof substrate being adhered to the surface of the first adhesive layer opposite the attachment surface; one side of the breathable waterproof substrate being adhered to the other side of the first waterproof substrate via a second adhesive layer; and one side of a second waterproof substrate being adhered to the other side of the breathable waterproof substrate via a third adhesive layer; the flow path being formed by a space formed in the breathable waterproof substrate.

[0007] This can prevent other liquids from being mixed into the collected biological sample.

[0008] FIG. 1 is a top view of a device; FIG. 2 is a diagram illustrating a device of a first embodiment; FIG. 3 is a diagram illustrating a device of a second embodiment; FIG. 4 is a diagram illustrating an example of a system configuration of an analysis system; FIG. 5 is a diagram illustrating an example of a hardware configuration of an analysis apparatus; FIG. 6 is a diagram illustrating a functional configuration of an analysis apparatus; and FIG. 7 is a flowchart illustrating processing of the analysis apparatus.

[0009] First Embodiment A device according to this embodiment will be described below with reference to Fig. 1. Fig. 1 is a top view of the device.

[0010] The device 100 of this embodiment is attached to a human body to collect a biological sample from the human body. In the following description, sweat exuded from the human body will be described as an example of the biological sample collected by the device 100.

[0011] Here, a description will be given of a usage scenario of the device 100 of this embodiment. In the following description, a person to whom the device 100 is attached may be referred to as a user of the device 100.

[0012] The device 100 of this embodiment may be attached to the user's body surface while the user is sweating a small amount. Specifically, the device 100 may be attached to the user's body surface while the user is showering, bathing, walking, or the like, or after any of these. Note that activities that cause a small amount of sweat are not limited to these and may include any activity in daily life.

[0013] The device 100 of this embodiment is formed with a flow path 110 and an inlet 120. The flow path 110 allows sweat produced on the user's body surface to flow into the device 100 through the inlet 120, and retains the sweat within the device 100. The inlet 120 allows the sweat produced on the user's body surface to flow into the flow path 110. The device 100 of this embodiment may be rectangular, with the flow path 110 and the inlet 120 formed along the longitudinal direction of the rectangle.

[0014] 1, the shape of the device 100 is rectangular and the flow path 110 is formed in the longitudinal direction of the rectangle, but this is not limiting. The shape of the device 100 may be circular or the like, and is not limited to a rectangle. Furthermore, the positions at which the flow path 110 and the inlet 120 are formed in the device 100 are not limited to the example shown in FIG. 1.

[0015] Next, the device 100 of this embodiment will be further described with reference to Fig. 2. Fig. 2 is a diagram illustrating the device of the first embodiment. Fig. 2(A) is an enlarged view of a region R1 including the flow channel 110 and the inlet 120 in the top view of the device 100 shown in Fig. 1, and Fig. 2(B) is a cross-sectional view taken along line A-A in Fig. 2(A).

[0016] The device 100 of this embodiment includes an adhesive layer 101 , a first layer substrate 102 , an adhesive layer 105 , a second layer substrate 103 , an adhesive layer 106 , and a third layer substrate 104 .

[0017] The adhesive layer 101 is formed of an adhesive for skin to attach the device 100 to the human body. One surface 101a of the adhesive layer 101 is the surface that adheres to the human body, and the other surface 101b is adhered to one surface 102a of the first layer base material 102. The adhesive layer 101 is an example of a first adhesive layer.

[0018] The first-layer substrate 102 is a waterproof substrate. In the first-layer substrate 102, the other surface 102b opposite to the one surface 102a is adhered to one surface 103a of the second-layer substrate 103 via an adhesive layer 105. The adhesive layer 105 is formed of an adhesive that adheres the first-layer substrate 102 and the second-layer substrate 103. The first-layer substrate 102 is an example of a first waterproof substrate, and the adhesive layer 105 is an example of a second adhesive layer.

[0019] The second layer substrate 103 is a moisture-permeable waterproof substrate, one side 103a of which is adhered to the first layer substrate 102 via an adhesive layer 105, and the other side 103b of which is adhered to one side 104a of the third layer substrate 104 via an adhesive layer 106.

[0020] The third-layer substrate 104 is a waterproof substrate. Specifically, the third-layer substrate 104 is a cover film or the like. The first-layer substrate 102 and the third-layer substrate 104 may be formed of the same material. One surface 104a of the third-layer substrate 104 is adhered to the other surface 103b of the second-layer substrate via an adhesive layer 106. The third-layer substrate 104 is an example of a second waterproof substrate, and the adhesive layer 106 is an example of a third adhesive layer.

[0021] 2(B), the pressure-sensitive adhesive layer 101 and the first layer substrate 102 are formed with an inlet 120 for allowing sweat exuded from the human body to flow into the flow path 110 when one surface 101a of the pressure-sensitive adhesive layer 101 is adhered to the surface of the human body. The inlet 120 passes through the pressure-sensitive adhesive layer 101, the first layer substrate 102, and the pressure-sensitive adhesive layer 105, and is connected to an end 112 which is one end of the flow path 110 formed in the second layer substrate 103.

[0022] The second layer substrate 103 has a flow path 110 formed therein, extending from an end 112 connected to the inlet 120 to a terminal end 113. The terminal end 113 of the flow path 110 is closed by the second layer substrate 103.

[0023] In this embodiment, the flow path 110 is a space formed by cutting out the second layer substrate 103. In other words, the flow path 110 is a space surrounded by the second layer substrate 103, which is a moisture-permeable waterproof substrate, the first layer substrate 102, which is a waterproof substrate, and the third layer substrate 104.

[0024] Therefore, in this embodiment, when sweat flows into the flow path 110 from the inlet 120, the air in the flow path 110 is discharged outside the flow path 110 through the second layer substrate 103, while the sweat that has flowed into the flow path 110 does not flow out to the outside of the flow path 110.

[0025] Therefore, according to this embodiment, even if there is no outlet for discharging the air in the flow path 110 to the outside, the air in the flow path 110 is discharged to the outside in response to the inflow of sweat into the flow path 110. Therefore, in this embodiment, the entire space that forms the flow path 110 can be filled with sweat, and even if the amount of sweat exuded from the body surface is small, the sweat can be stored in the flow path 110.

[0026] Furthermore, in this embodiment, since the third layer substrate 104 is a waterproof substrate, sweat accumulated in the flow path 110 can be prevented from evaporating.

[0027] Therefore, according to this embodiment, it is possible to collect a minute amount of sweat produced by the user. In other words, according to this embodiment, the device 100 can efficiently collect a minute amount of biological sample.

[0028] Since the device 100 of this embodiment can collect such a small amount of sweat, it is not necessary for the user to engage in exercise that would cause a large amount of sweat, and sweat can be collected from the user in everyday life. Therefore, this embodiment can reduce the burden on the user when collecting a biological sample.

[0029] Furthermore, in this embodiment, no liquid other than sweat flows into the flow path 110 from outside the flow path 110. Therefore, according to the device 100 of this embodiment, it is possible to prevent liquid other than sweat from mixing with the sweat collected as the subject of analysis, thereby improving the accuracy of the analysis.

[0030] Furthermore, the first layer substrate 102, the second layer substrate 103, and the third layer substrate 104 in this embodiment are flexible, which makes it possible to reduce pain and itching when the user applies the device 100 to the skin.

[0031] Furthermore, in this embodiment, sweat has been described as an example of a biological sample, but the biological sample collected by the device 100 may be, for example, saliva, tears, blood, interstitial fluid, urine, or the like.

[0032] Second Embodiment A second embodiment will be described below with reference to the drawings. The second embodiment differs from the first embodiment in that a detection unit for detecting a biological sample is provided in the flow channel 110. In the following description of the second embodiment, differences from the first embodiment will be described, and components having the same functional configuration as those in the first embodiment will be assigned the same reference numerals as those in the first embodiment, and descriptions thereof will be omitted.

[0033] 3A and 3B are diagrams illustrating a device according to a second embodiment of the present invention, in which Fig. 3A is an enlarged view of a region R1 including a channel 110 and an inlet 120 in a top view of the device 100A, and Fig. 3B is a cross-sectional view taken along line A-A in Fig. 3A.

[0034] In the device 100A of this embodiment, a detection unit 130 for detecting sweat is provided in the flow path 110.

[0035] The detection unit 130 of this embodiment is formed by drying and sealing in a reagent. The reagent is a colorimetric reagent that changes color in response to a substance contained in a biological sample.

[0036] In this embodiment, the reagent included in the detection unit 130 may change color in response to the pH value of the biological sample, or in response to the concentration of electrolytes (sodium, potassium, chloride ions, etc.) in the biological sample, or in response to the detection of an amino acid, such as valine, leucine, or isoleucine.

[0037] Furthermore, the detection unit 130 may be one that changes color depending on lactic acid, uric acid, protein, lipid, ketone, hormone, mRNA, iron, or the like.

[0038] The detection unit 130 of this embodiment may be disposed within the flow channel 110 at a position that is a predetermined distance L1 away from the terminal end 113 of the flow channel 110. In this embodiment, by disposing the detection unit 130 in this manner, the reagent that has changed color in response to a substance contained in the biological sample flows toward the terminal end 113, making it even easier to recognize the color change of the reagent.

[0039] Furthermore, the detection unit 130 may be arranged so that the distance L1 from the end 113 to the detection unit 130 is longer than the distance L2 from the detection unit 130 to the end 112. In this embodiment, by arranging the detection unit 130 in this manner, sweat can be quickly filled up to the detection unit 130.

[0040] In this embodiment, the detection unit 130 is disposed at a position that does not overlap with the inlet 120. More specifically, the detection unit 130 is disposed at a position that is a predetermined distance L2 away from the end 112 where the flow path 110 and the inlet 120 are connected. The distance L2 is longer than the width L3 of the inlet 120 in the A-A cross section.

[0041] In this embodiment, by arranging the detection unit 130 in this manner, it is possible to prevent the reagent enclosed in the detection unit 130 from coming into contact with the human body through the inlet 120, thereby improving safety.

[0042] In the present embodiment, the third layer base material 104 may be a transparent cover film, etc. By making the third layer base material 104 transparent, the color change of the detection unit 130 can be visually observed from the top surface of the device 100A through the third layer base material 104.

[0043] In this way, the device 100A of this embodiment can efficiently collect a small amount of sweat and detect the sweat based on the change in color of the detection unit 130.

[0044] In this embodiment, a colorimetric reagent is used as the method for detecting sweat by the detection unit 130, but the method for detecting sweat may be a method other than the method using a colorimetric reagent. For example, the detection unit 130 may be an electrode, and sweat may be detected electrochemically.

[0045] Furthermore, the device 100A of this embodiment may be included in an analysis system that analyzes the color change of the detection unit 130.

[0046] 4 is a diagram showing an example of the system configuration of an analysis system 10 according to this embodiment. The analysis system 10 includes a device 100A, a detector 300, and an analysis apparatus 400.

[0047] In the analysis system 10 of this embodiment, one of the substances contained in the biological sample is set as a target substance, and the concentration of the target substance is measured. In the following description, the target substance contained in the biological sample, the concentration of which is to be measured, is referred to as the measurement target.

[0048] In this embodiment, the measurement target is sodium ions (Na ＋ ), and the concentration of the object to be measured is sodium ion (Na ＋ The electrolyte was sodium ion (Na ＋ ), as well as chloride ions (Cl － ) etc.

[0049] The detector 300 of this embodiment extracts color information indicating the color of the detection unit 130 of the device 100A. In other words, the detector 300 extracts color information indicating the color of the reagent placed on the device 100A.

[0050] The color information in this embodiment may be, for example, RGB values ​​(R value, G value, B value). Specifically, the detector 300 in this embodiment may be, for example, an imaging device or a spectroscope. The detector 300 in this embodiment may be any device as long as it can detect color information indicating the color of the reagent.

[0051] The analyzer 400 of this embodiment acquires color information of the detection unit 130 of the device 100A from the detector 300, calculates the concentration of the measurement object from the color information, and outputs the result of the measurement.

[0052] The analysis device 400 of this embodiment will be described below. Fig. 5 is a diagram showing an example of the hardware configuration of the analysis device.

[0053] The analysis device 400 of this embodiment includes a processor 41, a memory 42, an auxiliary storage device 43, an I / F (Interface) device 44, a communication device 45, and a drive device 46. The hardware components of the analysis device 400 are connected to each other via a bus 47.

[0054] The processor 41 has various computing devices such as a CPU (Central Processing Unit), a GPU (Graphics Processing Unit), etc. The processor 41 reads various programs (for example, a learning program, etc.) into the memory 42 and executes them.

[0055] The memory 42 has a main storage device such as a read-only memory (ROM) or a random access memory (RAM). The processor 41 and the memory 42 form a so-called computer, and the processor 41 executes various programs read onto the memory 42, causing the computer to realize the functions of the analysis device 400, which will be described later.

[0056] The auxiliary storage device 43 stores various programs and various data used when the processor 41 executes the various programs.

[0057] The I / F device 44 is a connection device that connects the analysis device 400 with an operation device 48 and a display device 49, which are examples of external devices. The I / F device 44 accepts operations for the analysis device 400 via the operation device 48. The I / F device 44 may also output results of processing by the analysis device 400 and display them to an administrator of the analysis device 400 via the display device 49.

[0058] The communication device 45 is a communication device for communicating with other devices (in this embodiment, the detector 300).

[0059] The drive device 46 is a device for loading a recording medium 50. The recording medium 50 here includes media that record information optically, electrically, or magnetically, such as CD-ROMs, flexible disks, and magneto-optical disks. The recording medium 50 may also include semiconductor memories that record information electrically, such as ROMs and flash memories.

[0060] The various programs to be installed in the auxiliary storage device 43 are installed, for example, by setting the distributed recording medium 50 in the drive device 46 and reading the various programs recorded on the recording medium 50 by the drive device 46. Alternatively, the various programs to be installed in the auxiliary storage device 43 may be installed by being downloaded from a network via the communication device 45.

[0061] Next, functions of the analysis device 400 of this embodiment will be described with reference to Fig. 6. Fig. 6 is a diagram illustrating the functional configuration of the analysis device.

[0062] The analysis device 400 of this embodiment includes a color information acquisition unit 410 , a density calculation unit 420 , and an output unit 430 .

[0063] The color information acquisition unit 410 of this embodiment acquires the color information extracted by the detector 300 from each of the detection units 130 of the device 100A.

[0064] In addition, the color information of this embodiment may be, for example, if the detector 300 is an imaging device, the RGB values ​​of the image of the detection unit 130 extracted from image data showing an image of the device 100A captured after the reagent contained in the detection unit 130 reacts with the biological sample.

[0065] Furthermore, if the detector 300 is an imaging device, the color information may include luminance, color difference, hue, saturation, and brightness, which indicate the brightness of the image of the detector 130 .

[0066] The concentration calculation section 420 calculates the concentration of the measurement object using, for example, the color information acquired by the color information acquisition section 410 .

[0067] Specifically, the concentration calculation section 420 of this embodiment analyzes the color information acquired by the color information acquisition section 410, and acquires the concentration of the object to be measured as the measurement result.

[0068] The concentration calculation unit 420 of this embodiment may be realized by, for example, a trained model generated by machine learning using pre-created training data. In this case, the concentration calculation unit 420 may input the color information acquired by the color information acquisition unit 410 to the trained model, and acquire the concentration of the object to be measured output from the trained model as the measurement result.

[0069] Furthermore, if the relationship between the color and concentration of the reagent is expressed by a simple regression equation, the concentration calculation unit 420 can use this regression equation and does not need to use a trained model.

[0070] The output section 430 outputs the concentration of the measurement object calculated by the concentration calculation section 420 .

[0071] Next, the processing of the analysis device 400 of this embodiment will be described with reference to Fig. 7. Fig. 7 is a flowchart illustrating the processing of the analysis device.

[0072] The analysis device 400 of this embodiment acquires color information of the detection unit 130 of the device 100A extracted by the detector 300 using the color information acquisition unit 410 (step S701). Note that the analysis device 400 and the detector 300 may be connected via, for example, wireless communication, and the color information may be acquired by the analysis device 400 via communication.

[0073] Next, the concentration calculation unit 420 of the analysis device 400 calculates the concentration of the measurement object using the color information acquired in step S701 (step S702).

[0074] Next, the analyzer 400 causes the output unit 430 to output the concentration of the measurement object acquired by the concentration calculation unit 420 (step S703).

[0075] The process of Fig. 7 will be specifically described below. In the following description, the detector 300 will be described as an imaging device.

[0076] In device 100A, when a biological sample reaches detection unit 130, the color of the reagent contained in detection unit 130 changes. Detector 300 captures an image of device 100A after the color of the reagent contained in detection unit 230 has changed, and acquires image data.

[0077] The color information acquisition unit 410 of the analysis device 400 acquires image data from the detector 300 and identifies the image of the detection unit 130 from among the images indicated by the acquired image data. Specifically, for example, the color information acquisition unit 410 may identify a circular image included in the image of the device 100A as the image of the detection unit 130.

[0078] Next, the color information acquisition unit 410 extracts color information from the identified image. Specifically, the color information acquisition unit 410 may extract RGB values, luminance, color difference, hue, saturation, brightness, etc. of the identified image as color information.

[0079] In the analysis device 400, when the color information acquisition unit 410 acquires the color information from the detection unit 130, the concentration calculation unit 420 acquires the pH value, the concentration of sodium ions, etc. as the results of analyzing the color information.

[0080] In the above description, image data is acquired from the detector 300, and the color information of the detection unit 130 is extracted in the analysis device 400, but this is not limiting. The extraction of the color information may be performed in the detector 300.

[0081] In addition, in the above description, color information of the detection unit 130 is extracted based on image data of the device 100A, and the extracted color information is input into the trained model, but this is not limited to this.

[0082] In this embodiment, image data captured by the detector 300 may be input directly to the trained model. In this case, the trained model may extract color information from the input image data.

[0083] In this way, in this embodiment, when measuring the concentration of the target substance contained in a sample, the concentration of the target substance can be obtained using color information of the reagent after reacting with the target substance contained in sweat and color information of the reagent that has reacted to substances other than the target substance contained in sweat or the characteristics of the sample.

[0084] Furthermore, in the device 100A of this embodiment, it is possible to prevent bodily fluids other than sweat from flowing into the flow path 110, thereby reducing the effect of bodily fluids other than sweat on the color change of the reagent, thereby improving the accuracy of the analysis.

[0085] The present invention is not limited to the configurations described in the above embodiments, but may be combined with other elements, etc. These aspects can be changed without departing from the spirit of the present invention, and can be appropriately determined depending on the application form.

[0086] This international application claims priority based on Japanese Patent Application No. 2024-102556 filed on June 26, 2024, and the entire contents of Japanese Patent Application No. 2024-102556 are incorporated herein by reference.

[0087] REFERENCE SIGNS LIST 10 Analysis system 100, 100A Device 101, 105, 106 Adhesive layer 102 First layer substrate 103 Second layer substrate 104 Third layer substrate 110 Flow path 120 Inlet 130 Detection unit

Claims

1. A device for collecting a biological sample from a living organism, comprising: a first adhesive layer having an inlet for the biological sample formed in part of its surface to be attached to the living organism; and a breathable waterproof substrate laminated to the first adhesive layer, having a flow path formed therein for allowing the biological sample to flow from the inlet into the device, wherein the flow path is surrounded by a breathable waterproof material; one side of the first waterproof substrate is adhered to the surface of the first adhesive layer opposite the attachment surface; one side of the breathable waterproof substrate is adhered to the other side of the first waterproof substrate via a second adhesive layer; and one side of a second waterproof substrate is adhered to the other side of the breathable waterproof substrate via a third adhesive layer; and the flow path is formed by a space formed in the breathable waterproof substrate.

2. The device according to claim 1, wherein a detection unit for detecting the biological sample is disposed on the flow path.

3. The device according to claim 2, wherein the detection unit is positioned at a predetermined distance from the end of the flow path.

4. The device according to claim 2, wherein the detection unit is located at a predetermined distance from the inlet.

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