Biological information acquisition sensor, biological information acquisition device, and biological information acquisition method

The combination of electromyography and ultrasound imaging using a sensor sheet and ultrasonic probe provides a comprehensive and accurate method for monitoring pelvic floor muscle activity, addressing the limitations of existing evaluation methods and improving exercise effectiveness.

JP2026122571APending Publication Date: 2026-07-29NOK CORP
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
NOK CORP
Filing Date
2025-01-16
Publication Date
2026-07-29

AI Technical Summary

Technical Problem

Existing methods for evaluating pelvic floor muscle exercise effectiveness, such as electromyography and ultrasound imaging, face challenges including psychological discomfort, gender limitations, and cumbersome operation, making it difficult to accurately monitor muscle activity during exercises.

Method used

A biological information acquisition system comprising a sensor sheet with electrodes and an ultrasonic probe that measures electromyographic signals from the transversus abdominis muscle and combines them with ultrasound imaging of the bladder to provide comprehensive feedback on pelvic floor muscle activity.

Benefits of technology

Enables easy and accurate monitoring of pelvic floor muscle activity, allowing instructors to provide effective feedback and individuals to learn the correct technique, thereby enhancing the effectiveness of pelvic floor muscle exercises.

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Abstract

To enable easy and accurate monitoring of pelvic floor muscle activity during pelvic floor muscle exercises. [Solution] To confirm the activity of the pelvic floor muscles during pelvic floor muscle exercises, a sensor sheet 101 is attached to the abdominal region 12 corresponding to the transversus abdominis muscle, and an electromyogram of the transversus abdominis muscle, which contracts in coordination with the pelvic floor muscles, is obtained. However, even if the transversus abdominis muscle contracts, this does not necessarily mean that the pelvic floor muscles are also contracting, so the activity of the pelvic floor muscles is confirmed by ultrasound. More specifically, an ultrasound probe is placed over the sensor sheet 101, and an ultrasound sensor 201 is pressed against the abdominal region 12 to obtain an ultrasound image (M-mode image) showing the activity of the bladder base, which can be identified with the contraction of the pelvic floor muscles. This makes it possible to help practitioners of pelvic floor muscle exercises learn the knack for contracting the pelvic floor muscles, that is, which parts of the body to focus on and how to do so.
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Description

Technical Field

[0006]

[0001] The present disclosure relates to a biological information acquisition sensor, a biological information acquisition device, and a biological information acquisition method.

Background Art

[0002] The pelvic floor muscle exercise, which has attracted attention in recent years, is said to originate from the Kegel exercise proposed by the American obstetrician Arnold Kegel in the 1940s. Kegel devised the Kegel exercise as part of the treatment for female patients suffering from urinary incontinence. <00,00010>

[0003] The pelvic floor muscle is a muscle located at the bottom of the pelvis (see FIGS. 1(A)-(C)), and plays a role in supporting the organs in the pelvis. The pelvic floor muscle group centered on the pelvic floor muscle includes the urethral sphincter muscle. It is considered that when a woman experiences childbirth, the pelvic floor muscle group relaxes during childbirth, resulting in a weakened sphincter function and accompanying cases of urinary incontinence. The pelvic floor muscle exercise enhances the sphincter function by strengthening the pelvic floor muscle, leading to improvement in urinary incontinence.

[0004] The pelvic floor muscle exercise not only improves urinary incontinence but also undertakes functional training of the deep muscles of the trunk, so it is also effective in maintaining posture and improving low back pain. It is expected to bring meaningful results in extending the healthy life span and maintaining and improving QOL (Quality of Life).

[0005] On the other hand, there is a knack to the pelvic floor muscle exercise, and it is difficult to be aware of whether it is effective for the pelvic floor muscle. Moreover, the pelvic floor muscle is an inner muscle, and the shape change during training cannot be confirmed from outside the body. Therefore, the instructor or practitioner of the pelvic floor muscle exercise cannot know the state of the pelvic floor muscle during training and cannot confirm the effect of the training.

[0006] Against this backdrop, research is underway on biofeedback technologies to visualize the activity level of pelvic floor muscles during training. For example, Non-Patent Literature 1 describes pelvic floor muscle exercises, specifically the HA breathing method and HU breathing method, performed in a lateral position, along with the ability to confirm the activity level of the pelvic floor muscles from electromyography based on electromyographic signals collected from subjects. (See page 82 of Non-Patent Literature 1, "2-4. Measurement Items and Measurement Methods").

[0007] Another example of biofeedback technology is described in Patent Document 1, which involves acquiring an ultrasound image of the bladder using an ultrasound probe (2) and displaying it on the touch panel screen (11) of a portable information terminal (1) (see paragraphs 0040-0042, 0104, and 0130 of Patent Document 1). Patent Document 1 describes a method for confirming the contraction of the pelvic floor muscles from changes in the size of the bladder (see paragraph 0129 of Patent Document 1). [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] Japanese Patent Publication No. 2022-120842 [Patent Document 2] Japanese Patent Publication No. 2019-051236 [Non-patent literature]

[0009] [Non-Patent Document 1] Kazumi Tsujino, Satoko Hoshino, "Examination of Breathing Techniques for Effective Pelvic Floor Muscle Contraction: A Practical Approach to Exercise Instruction for Middle-Aged and Elderly Women," Japan Health and Fitness Foundation, Research Grant, 2017, pp. 79-90. [Overview of the project] [Problems that the invention aims to solve]

[0010] In Non-Patent Document 1, the electromyography (EMG) of the pelvic floor muscles is measured by inserting a special probe into the woman's vagina. In other words, the electromyogram of the pelvic floor muscles is obtained as an intravaginal electromyogram. Since the intravaginal electromyogram shows the effects of contraction of the perineum, including the vaginal sphincter and the surrounding external urethral sphincter and external anal sphincter, as well as the contraction of the pelvic diaphragm, the intravaginal electromyogram can be used as an indicator for measuring the amount of muscle activity of the pelvic floor muscles.

[0011] However, collecting intravaginal electromyography data to measure pelvic floor muscle activity is likely to be psychologically uncomfortable. Furthermore, considerations would need to be given to factors such as the gender of the supervisor assisting with the measurement, and the location of the measurement is not a limiting factor. Moreover, this measurement method is exclusively applicable to women and cannot be used for men.

[0012] In this regard, Non-Patent Document 1 discusses the relationship between the contraction of the transversus abdominis and rectus abdominis muscles (see Figure 2) and the contraction of the pelvic floor muscles, and verifies the relationship between the measurement results of electromyography (EMG) between the pelvic floor muscles and the transversus abdominis and rectus abdominis muscles (hereinafter referred to as "transversus abdominis, etc.") (see pages 82-89 of Non-Patent Document 1). Since the EMG of the transversus abdominis, etc. can be measured on the body surface regardless of gender, psychological resistance will be significantly reduced.

[0013] Regarding the crucial relationship between the contraction of the pelvic floor muscles and the transversus abdominis muscle, Non-Patent Literature 1 has confirmed that during rhythmic contraction tasks involving voluntary contraction of the pelvic floor muscles, the pelvic floor muscles and the transversus abdominis muscle cooperate to maintain their muscle activity (see Non-Patent Literature 1, page 88, sections "3-8" and "3-8-1"). For more information on "voluntary contraction of the pelvic floor muscles" and "rhythmic contraction tasks," please refer to Non-Patent Literature 1, pages 80-81, sections "2-3-1" to "2-3-3."

[0014] On the other hand, it has been confirmed that even when performing rhythmic contraction tasks involving voluntary contraction of the pelvic floor muscles, there are cases where cooperative contraction between the pelvic floor muscles and the transversus abdominis muscle, etc., is not demonstrated (see Non-Patent Literature 1, page 88, "3-8-2"). Therefore, while evaluating the electromyography of the transversus abdominis muscle, etc., during pelvic floor muscle training can be one method for estimating the muscle activity of the pelvic floor muscles, it is known that the activity of the transversus abdominis muscle, etc., does not necessarily mean that the pelvic floor muscles are working, and it is not possible to completely estimate the muscle activity of the pelvic floor muscles from the electromyography of the transversus abdominis muscle, etc.

[0015] Ultrasound images, such as those suggested in Patent Document 1, faithfully reproduce internal body movements and are therefore highly reliable as derivative feedback indicating pelvic floor muscle activity. On the other hand, acquiring ultrasound images requires holding an ultrasound sensor containing a relatively large and bulky ultrasound probe and pressing it against the abdomen, which is burdensome during operation. Moreover, the ultrasound sensor must be pressed against the abdomen, causing discomfort during continuous use. Ultrasound images are not suitable for continuous evaluation over time.

[0016] In summary, while electromyography-based and ultrasound imaging-based evaluation methods were mentioned as real-time assessment methods for confirming the effects of pelvic floor muscle exercises, each has its advantages and disadvantages, and no single method is definitively superior. It is desirable to improve the accuracy of the evaluation while using the readily available electromyography-based evaluation method for muscles such as the transversus abdominis as a basis.

[0017] The objective of this disclosure is to enable easy and accurate monitoring of pelvic floor muscle activity during pelvic floor muscle exercises. [Means for solving the problem]

[0018] One aspect of the biological information acquisition sensor includes a sensor sheet attached to the human body to acquire an electrical signal generated by muscles, and an ultrasonic probe applied onto the sensor sheet attached to the human body, and an ultrasonic sensor that receives an ultrasonic echo signal from the human body. The sensor sheet includes a sheet made of an elastomer, a plurality of electrodes provided on the sheet and made of an elastomer with conductivity imparted thereto, a plurality of wirings provided on the sheet and connected to the electrodes respectively and made of an elastomer with conductivity imparted thereto, and an insulating layer made of an elastomer fixed to the sheet so as to cover the wirings leaving the electrode portions.

[0019] One aspect of the biological information acquisition device includes the above biological information acquisition sensor, an electromyogram generation unit that generates image data of an electromyogram based on an electrical signal taken out from an output end of the wiring included in the sensor sheet, and an echo image generation unit that generates image data of an ultrasonic echo based on a signal of the ultrasonic echo output by the ultrasonic probe included in the ultrasonic sensor.

[0020] One aspect of the biological information acquisition method is a biological information acquisition method using the above biological information acquisition sensor. The method includes attaching the sensor sheet to a region of the abdomen corresponding to the transverse abdominal muscle, and pressing the ultrasonic sensor against the abdomen so as to apply the ultrasonic probe onto the sensor sheet attached to the human body.

Effect of the Invention

[0021] During the execution of pelvic floor muscle exercise, the activity state of the pelvic floor muscles can be easily and accurately grasped.

Brief Description of the Drawings

[0022] [Figure 1] (A) is a schematic diagram of the back side of the human body showing the positions of the pelvic floor muscle groups, (B) is a side view of the human body showing the position and shape of the pelvic floor muscles of a male, and (C) is a side view of the human body showing the position and shape of the pelvic floor muscles of a female. [Figure 2] A schematic diagram of the front side of the human body showing a muscle group including the transverse abdominal muscle. [Figure 3] As an example of a posture when training the pelvic floor muscles, a schematic diagram illustrating a performer of pelvic floor muscle exercises in a lying position. [Figure 4] A schematic diagram showing one aspect when a biological information acquisition sensor is attached to a performer of pelvic floor muscle exercises in a lying position and the biological information acquisition method is implemented. [Figure 5] A plan view of the sensor sheet. [Figure 6] A cross-sectional view taken along line A-A in FIG. 5. [Figure 7] A plan view of the sensor sheet shown with the insulating layer removed. [Figure 8] A block diagram showing an example of an electromyogram generation unit. [Figure 9] A block diagram showing an example of an echo image generation unit. [Figure 10] A block diagram showing another example of an electromyogram generation unit. [Figure 11] A block diagram showing another example of an echo image generation unit. [Figure 12] A block diagram showing another example of an image generation unit (electromyogram generation unit and echo image generation unit). [Figure 13] A block diagram showing yet another example of an image generation unit (electromyogram generation unit and echo image generation unit). [Figure 14] As an experimental example using a phantom, (A) shows a correspondence between a configuration example of each part and an M-mode image in an experiment without using the sensor sheet (comparative experiment), and (B) shows a correspondence between a configuration example of each part and an M-mode image in an experiment using the sensor sheet (verification experiment). [Figure 15] (A) shows an echo image obtained in the comparative experiment, and (B) shows an echo image obtained in the verification experiment. [Figure 16] A graph showing waveforms of echo intensities obtained during the experiments shown in FIGS. 14(A) and (B). [Figure 17]As examples of experiments using the human body, (A) is a schematic diagram showing an ultrasound image obtained during muscle relaxation in a comparative experiment, (B) is a schematic diagram showing an ultrasound image obtained during muscle contraction in a comparative experiment, (C) is a schematic diagram showing an ultrasound image obtained during muscle relaxation in a verification experiment, and (D) is a schematic diagram showing an ultrasound image obtained during muscle contraction in a verification experiment. [Figure 18] Graphs showing the muscle contraction timing from Figures 17(B) and 17(D) superimposed on electromyogram images obtained from verification experiments. [Modes for carrying out the invention]

[0023] The embodiments will be described below with reference to the drawings. 1. Overview 2. Evaluation using electromyography (1) Sensor sheet (2) Electromyogram generation unit 3. Evaluation using ultrasound imaging (1) Ultrasonic sensor (2) Echo image generation unit 4. Biometric Information Acquisition Device 5. Method for acquiring biometric information (1) First process (2) Second process (3) Summary 6. An example of a different image generation unit (1) Electromyogram generation unit (2) Echo image generation unit (3) Display method 7. An example of a different image generation unit 8. Another example of the image generation unit 9. Variations

[0024] 1. Overview This embodiment discloses a biological information acquisition sensor, a biological information acquisition device, and a biological information acquisition method. The biological information acquisition sensor, and the biological information acquisition device and method using the same, of this embodiment are intended to acquire the amount of pelvic floor muscle contraction as biological information in order to check the activity of the pelvic floor muscles when performing pelvic floor muscle exercises.

[0025] As shown in Figure 1, the pelvic floor muscles are located at the bottom of the pelvis and support the organs within the pelvis (see Figures 1(A)-(C)), and it is difficult to directly obtain the amount of their contraction. Therefore, in this embodiment, the amount of pelvic floor muscle contraction is estimated by measuring the electromyogram obtained by measuring the electromyographic potential of the transversus abdominis muscle, which has been confirmed to contract in coordination with the pelvic floor muscles, i.e., the electrical signals generated by the muscle (see Non-Patent Literature 1, page 88, "3-8-1").

[0026] As shown in Figure 2, the transversus abdominis muscle is located medial to the internal oblique muscle. The electromyographic activity of the transversus abdominis muscle can be acquired from the abdomen 12 of the human body 11 using electrodes attached to the body surface (see Figure 2-3).

[0027] Pelvic floor muscle exercises are performed in a lateral recumbent position, as shown in Figure 3, using the HA breathing method. The HA breathing method is a breathing technique that primarily contracts the lower transversus abdominis muscle (see Non-Patent Literature 1, pages 79 and 81, "(1) HA breathing method").

[0028] As shown in Figure 4, in this embodiment, in order to extract the electromyographic potential of the transversus abdominis muscle, a sensor sheet 101 is attached to the region of the abdomen 12 of the human body 11 that corresponds to the transversus abdominis muscle. The sensor sheet 101 functions as a bio-information acquisition sensor BIS, and the electromyographic potential of the transversus abdominis muscle acquired by the sensor sheet 101 is converted into electromyographic image data by the electromyographic generation units 131A to D and displayed as an electromyographic image on the monitor 172 (see Figure 8).

[0029] On the other hand, as mentioned above, it has been confirmed that synergistic contraction between the pelvic floor muscles and the transversus abdominis muscle does not always occur (see Non-Patent Document 1, page 88, "3-8-2"). For this reason, it is not possible to fully estimate the muscle activity of the pelvic floor muscles from electromyography of the transversus abdominis muscle alone.

[0030] Therefore, in this embodiment, the acquisition of biological information using ultrasound echo is appropriately combined to allow visual confirmation of the degree of pelvic floor muscle contraction. However, what is visualized as an ultrasound image is not the contraction of the pelvic floor muscles themselves, but rather an image of the bladder (see Figure 1(B)(C)). Since the bottom of the bladder is linked to the contraction of the pelvic floor muscles, the ultrasound image of the bladder can be considered identical to the contraction of the pelvic floor muscles.

[0031] As shown in Figure 4, in order to obtain an ultrasound image of the bladder base that can be identified with an image of pelvic floor muscle contraction, the ultrasound probe 202 (see Figure 9) built into the ultrasound sensor 201 is pressed against the abdomen 12 of the human body 11. The ultrasound sensor 201 functions as a bio-information acquisition sensor (BIS), and the ultrasound echo signal acquired by the ultrasound probe 202 is converted into ultrasound echo image data by the echo image generation units 211A to D and displayed as an echo image on the monitor 272 (see Figure 9).

[0032] Thus, in the biological information acquisition method of this embodiment, a first step is to prepare a sensor sheet 101 and attach it to the area of ​​the abdomen 12 corresponding to the transverse abdominal muscle, and a second step is to press the ultrasonic sensor 201 against the abdomen 12. In the second step, in order to position the ultrasonic probe 202 at the location of the bladder, the ultrasonic probe 202 is placed on the sensor sheet 101 attached to the human body 11, and the ultrasonic sensor 201 is pressed against the abdomen 12.

[0033] According to this embodiment, since the ultrasonic sensor 201 is pressed against the sensor sheet 101 and the ultrasonic echo signal is acquired by the ultrasonic probe 202 in this state, the sensor sheet 101 is required to have a specific structure for this purpose. The structure of the sensor sheet 101 will be described in detail later.

[0034] In actual operation, a sensor sheet 101 is attached to the abdomen 12 to monitor the activity of the pelvic floor muscles, and the activity of the transverse abdominal muscle is monitored. Even if the transverse abdominal muscle is active, the pelvic floor muscles may not be contracting sufficiently. Therefore, the ultrasound image of the bladder acquired by the ultrasound sensor 201 is monitored as needed, and the activity of the pelvic floor muscles is confirmed from the visualized state of the bottom of the bladder. This allows instructors and practitioners of pelvic floor muscle exercises to know the state of the pelvic floor muscles during training.

[0035] As a result, instructors can provide appropriate advice to those performing pelvic floor muscle exercises. Those performing the exercises can receive feedback on whether the training was effective, and by accumulating this experience, they can learn the knack for contracting the pelvic floor muscles—that is, which parts of the body to focus on and how to do so.

[0036] 2. Evaluation using electromyography As mentioned above, the components necessary for generating an electromyogram (EMG) are the sensor sheet 101 as a bio-information acquisition sensor (BIS) and the EMG generation units 131A to D. In this embodiment, the EMG generation unit is denoted by reference numeral 131A, while the EMG generation units of the three other embodiments described later are denoted by reference numerals 131B to D, respectively.

[0037] (1) Sensor sheet As shown in Figures 5 to 7, the sensor sheet 101 has six electrodes 112 on a rectangular sheet 111. The electrodes 112 are arranged in a grid of three on one side and three on the other side at both ends of the sheet 111 in the width direction.

[0038] As shown in Figure 6, which is a cross-section along line AA in Figure 5, the electrode 112 and the wiring 113 are laminated in the same layer on the sheet 111, and an insulating layer 114 is further laminated to cover the peripheral portion of the electrode 112 and the wiring 113.

[0039] The sheet 111, electrode 112, wiring 113, and insulating layer 114 are all made from elastomer material. For example, urethane elastomers are used as elastomers. However, not limited to urethane elastomers, various elastomers can be used as appropriate, as long as they have the property of transmitting ultrasonic waves generated by the ultrasonic probe 202 built into the ultrasonic sensor 201. Examples include polyester elastomers, styrene elastomers, polyolefin elastomers, and polyamide elastomers.

[0040] Sheet 111 is the base component of the entire structure and has a stepped shape in which the width of the area to which the wiring 113 extends is narrowed relative to the area where the electrodes 112 are placed. The thickness of sheet 111 is 50 μm or less, for example, 10 to 25 μm or less. Therefore, sheet 111 not only has elasticity and flexibility, but also adheres to objects such as the human body 11.

[0041] The electrode 112 has a circular shape. The wiring 113 has a linear shape with one end connected to the electrode 112. The end of the wiring 113 on the opposite side of the connection end to the electrode 112 protrudes from the end of the sheet 111. This protruding portion is an output terminal 113a that is connected to a connecting wire 115 (described later) by a coupler (not shown).

[0042] The electrodes 112 and wiring 113 of this shape are made conductive. Conductivity is imparted, for example, by forming the electrodes 112 and wiring 113 with a conductive composite material in which conductive particles or conductive fibers are dispersed within an elastomer. As another example, conductivity may be imparted by forming the electrodes 112 and wiring 113 with an organic conductive polymer compound.

[0043] The electrodes 112 and wiring 113 are formed on the sheet 111 by printing methods such as screen printing, inkjet printing, gravure printing, or offset printing. As a result, the electrodes 112 and wiring 113 are sufficiently thin and, like the sheet 111, possess stretchability and flexibility.

[0044] The insulating layer 114 is a component with a thickness of 50 μm or less, for example, 10 to 25 μm or less, which is sufficient to maintain insulation against the wiring 113. Similar to the sheet 111, the insulating layer 114 not only has elasticity and flexibility, but also adheres to objects such as the human body 11.

[0045] The insulating layer 114 not only covers one side of the sheet 111 on which the electrodes 112 and wiring 113 are formed, but also protrudes beyond the sheet 111 at the output terminal 113a of the wiring 113, supporting the output terminal 113a. In a predetermined region including the portion supporting the output terminal 113a, the insulating layer 114 may be formed from a separate, more rigid member.

[0046] The sensor sheet 101, configured as described above, is attached to the human body 11 with the side of the insulating layer 114 where the electrodes 112 are exposed in contact with the body. At this time, the sensor sheet 101 is thin enough to conform to the shape of an object such as the human body 11, not only individually as a whole but also as a whole. Therefore, the sensor sheet 101 maintains close contact with the human body 11, including the abdomen 12. However, if necessary, an adhesive layer (not shown) having properties that transmit ultrasonic waves and insulating properties may be provided on the contact surface with the human body 11 (the upper surface in Figure 6).

[0047] Figure 6, which shows the cross-sectional shape of the sensor sheet 101, exaggerates the thickness of each part. Therefore, referring to Figure 6, it appears that the surface of the electrode 112 is positioned considerably deeper than the surface of the insulating layer 114, and that it does not come into contact with the human body 11 at all, or if it does, only a small area of ​​contact. In contrast, the thickness of the insulating layer 114 is 50 μm or less, for example, 10 to 25 μm or less, so the thickness dimension of the insulating layer 114 from the surface of the electrode 112 is minimal and does not hinder the contact of the electrode 112 with the human body 11. When the sensor sheet 101 is attached to the human body 11, the six electrodes 112 come into contact with the body over a sufficient area.

[0048] The sensor sheet 101 described above is related to the technology described in Patent Document 2. However, Patent Document 2 only describes an electrode sheet formed thinly from an elastomer as the material. Patent Document 2 does not disclose or suggest anything about the properties of transmitting ultrasonic waves.

[0049] (2) Electromyogram generation unit As shown in Figure 8, the electromyogram generation unit 131A is connected to the sensor sheet 101 by connectors CN1 and CN2.

[0050] Connector CN1 is the connector on the sensor sheet 101 side, and is connected to the wiring 113 by a connecting wire 115. The electrodes 112 provided on the sensor sheet 101 are arranged in two rows of three electrodes each. To simplify the explanation, we will use a single row of three electrodes as an example and describe the connection to the electromyogram generation unit 131A.

[0051] A set of electrodes 112 consists of a first electrode, a second electrode, and a body ground, each with a different role. For example, in Figure 5, from right to left, they are the first electrode, the body ground, and the second electrode, and in Figure 8, from top to bottom, they are the first electrode, the body ground, and the second electrode.

[0052] Therefore, from connector CN2 on the electromyogram generation unit 131A side, which is connected to connector CN1, wiring corresponding to the first electrode, body ground, and second electrode are drawn out in order from top to bottom in Figure 8.

[0053] The electromyogram generation unit 131A comprises two buffer amplifiers 132 and 133 and one differential amplifier 134. The first electrode, drawn from connector CN2, is connected to the positive terminal of buffer amplifier 132, and the negative terminal and output terminal of buffer amplifier 132 are connected to the positive terminal of differential amplifier 134. The second electrode, drawn from connector CN2, is connected to the positive terminal of buffer amplifier 133, and the negative terminal and output terminal of buffer amplifier 133 are connected to the negative terminal of differential amplifier 134. The body ground is connected to the ground terminal of differential amplifier 134.

[0054] A circuit having two buffer amplifiers 132 and 133 and one differential amplifier 134 outputs an electromyographic signal using a bipolar induction method. More specifically, the potential difference between the first electrode and body ground and the potential difference between the second electrode and body ground are determined, and the difference between the potential difference generated at the first electrode and the potential difference generated at the second electrode is output from the output terminal of the differential amplifier 134 as an electromyographic signal, that is, an electrical signal generated by the muscle.

[0055] The output signal of the differential amplifier 134 is filtered by the filter 135, amplified by the amplifier 136, and input to the analysis processing unit 137.

[0056] Filter 135 incorporates low-pass and high-pass filters to remove unwanted low and high frequencies from the output signal of the differential amplifier 134. Amplifier 136 amplifies the signal that has passed through filter 135 and outputs it to the analysis processing unit 137.

[0057] The analysis processing unit 137 digitally converts the signal output from the amplifier 136 and performs various processing to generate electromyogram image data. Therefore, the analysis processing unit 137 can be said to be the core circuit of the electromyogram generation unit 131A, which performs image generation processing based on the electrical signal taken from the output terminal 113a of the wiring 113 of the sensor sheet 101 and generates electromyogram image data.

[0058] The electromyogram generation unit 131A includes a main control unit 151. The main control unit 151 is composed of, for example, a microcomputer that interprets and executes a program, or an integrated circuit that sequentially executes prescribed processing, and is in charge of controlling the analysis processing unit 137 and the display control circuit 171. Image data generated by the analysis processing unit 137 is sent to the display control circuit 171 by command from the main control unit 151, and is displayed on the monitor 172 as an electromyogram according to the display control of the display control circuit 171.

[0059] Instructors and practitioners of pelvic floor muscle exercises can understand the activity level of the transversus abdominis muscle (see Figure 2) by observing the electromyogram displayed on monitor 172.

[0060] 3. Evaluation using ultrasound imaging As mentioned above, the components necessary for generating an echo image are the ultrasonic sensor 201 as a biological information acquisition sensor (BIS) and the echo image generation units 211A to D. In this embodiment, the echo image generation unit is denoted by reference numeral 211A, and the echo image generation units of the three other embodiments described later are denoted by reference numerals 211B to D, respectively.

[0061] (1) Ultrasonic sensor As shown in Figure 9, the ultrasonic sensor 201 has an ultrasonic probe 202 built into a handy-type housing (see Figure 4) that can be held in one hand and pressed against the human body 11. The ultrasonic probe 202 is equipped with a transducer array 203 which has multiple ultrasonic transducers arranged to emit ultrasonic waves. The transducer array 203 receives ultrasonic echoes that have reflected back from inside the human body 11 and outputs them as ultrasonic echo signals.

[0062] Each ultrasonic transducer constituting the transducer array 203 has a structure (not shown) in which electrodes are provided at both ends of a piezoelectric material such as a piezoelectric ceramic, polymer piezoelectric element, or piezoelectric single crystal.

[0063] In this embodiment, the ultrasonic probe 202 is placed on a sensor sheet 101 attached to the abdominal region 12 corresponding to the transversus abdominis muscle, and the ultrasonic sensor 201 is pressed against the human body 11. When the transducer array 203 emits ultrasound at this position, it is possible to acquire the ultrasound echo reflected from the bladder. At this time, since the sensor sheet 101 is made entirely of elastomer, the ultrasound irradiated from the transducer array 203 propagates within the sensor sheet 101. The ultrasound echo returning from the human body 11 also propagates within the sensor sheet 101 and is received by the transducer array 203.

[0064] (2) Echo image generation unit The echo image generation unit 211A comprises an echo signal transmission / reception circuit 231, an ultrasonic image generation unit 241, a main control unit 251, and a display control circuit 271. The main control unit 251 is composed of, for example, a microcomputer that interprets and executes a program, or an integrated circuit that sequentially executes prescribed processing, and is responsible for controlling the echo signal transmission / reception circuit 231, the ultrasonic image generation unit 241, and the display control circuit 271.

[0065] The echo signal transmission / reception circuit 231 includes a pulse generator 232 that drives the transducer array 203 of the ultrasonic probe 202. The pulse generator 232 is a collection of multiple pulse oscillators. Each oscillator outputs a drive signal (voltage) with an adjusted delay amount to the electrodes of the individual ultrasonic transducers constituting the transducer array 203, based on a transmission delay pattern corresponding to a control signal from the main control unit 251. When a pulsed or continuous wave voltage is applied to the electrodes of the individual ultrasonic transducers of the transducer array 203, the piezoelectric material expands and contracts, generating pulsed or continuous wave ultrasound from each ultrasonic transducer. An ultrasonic beam is generated by the combined wave of these ultrasounds.

[0066] The ultrasonic waves emitted by the transducer array 203 are reflected from the inside of the human body 11, in this embodiment from the bladder, and returned to the transducer array 203 as ultrasonic echoes. The transducer array 203 outputs a signal corresponding to the received ultrasonic echo.

[0067] The echo signal transmission and reception circuit 231 includes an amplifier 233, an AD converter 234, and a beamformer 235.

[0068] The ultrasonic echo signal output by the transducer array 203 is amplified by the amplifier 233, converted into a digital signal by the AD converter 234, and then input to the beamformer 235. The beamformer 235 performs reception focus processing by adding the digitized signals from each ultrasonic transducer of the transducer array 203, which it receives from the AD converter 234, with a corresponding delay applied to each signal. Through reception focus processing, the output signals of each ultrasonic transducer, which have been digitally converted by the AD converter 234, are added together as integers, and ultrasonic image data is generated in which the focus of the ultrasonic echo is narrowed.

[0069] The ultrasonic image generation unit 241 has a signal processing unit 242, a DSC (digital scan converter) 243, and an image processing unit 244 connected in series.

[0070] The signal processing unit 242 performs various processes on the ultrasonic image data output from the beamformer 235 of the echo signal transmission / reception circuit 231 to generate M-mode image data.

[0071] The DSC243 rasterizes the M-mode image data generated by the signal processing unit 242 and converts it into image data that conforms to the scanning method of a normal television signal.

[0072] The image processing unit 244 performs various image processing operations on the image data converted by the DSC 243, and then sends it to the display control circuit 271 according to the commands from the main control unit 251.

[0073] The display control circuit 271, under the control of the main control unit 251, displays an ultrasound image (M-mode image) on the monitor 272, according to the ultrasound image data output from the image processing unit 244. The image displayed on the monitor 272 is a motion image of the bladder.

[0074] As mentioned above, instructors and practitioners of pelvic floor muscle exercises understand the activity of the transverse abdominal muscle (see Figure 2) by observing the electromyogram displayed on monitor 172. At the same time, by referring to the bladder motion image (M-mode image) displayed on monitor 272, it is possible to confirm whether the pelvic floor muscles are actually contracting as a result of the pelvic floor muscle exercises being performed.

[0075] 4. Biometric Information Acquisition Device In this embodiment, the configuration for generating electromyograms includes a sensor sheet 101 and an electromyogram generation unit 131A as an image generation unit. Furthermore, the configuration for generating echo images includes an ultrasonic sensor 201 and an echo image generation unit 211A as an image generation unit.

[0076] The electromyogram generation unit 131A generates electromyogram image data based on the electrical signals taken from the output terminal 113a of the wiring 113 of the sensor sheet 101.

[0077] The echo image generation unit 211A generates ultrasound echo image data based on the ultrasound echo signal output by the ultrasound probe 202 of the ultrasound sensor 201.

[0078] In this embodiment, the sensor sheet 101 and the ultrasonic sensor 201 are understood as a biological information acquisition sensor BIS. By adding the electromyogram generation unit 131A and the echo image generation unit 211A to the biological information acquisition sensor BIS, the biological information acquisition devices BIA-A to D are constructed. The biological information acquisition device in this embodiment is denoted by the code BIA-A, while the biological information acquisition devices of the other three embodiments described later are denoted by the codes BIA-B to D, respectively.

[0079] 5. Method for acquiring biometric information In this embodiment, a bio-information acquisition sensor BIS (sensor sheet 101, ultrasonic sensor 201) is applied to a person performing pelvic floor muscle exercises, and the activity state of the pelvic floor muscles is observed using a bio-information acquisition device BIA-A (electromyogram generation unit 131A, echo image generation unit 211A).

[0080] At this time, the method for acquiring biological information consists of a first step of attaching a sensor sheet 101 to the abdominal region corresponding to the transverse abdominal muscle, and a second step of pressing an ultrasonic sensor 201 against the abdomen 12 so as to place the ultrasonic probe 202 on top of the sensor sheet 101 attached to the human body 11.

[0081] (1) First process The sensor sheet 101 is attached to the human body 11 so that the side with the insulating layer 114, where the electrode 112 is exposed, is in contact with the body. The position where the sensor sheet 101 is attached is the abdominal region 12 corresponding to the transversus abdominis muscle (see Figures 2 and 4).

[0082] The sensor sheet 101 is composed of an elastomer sheet 111, electrodes 112, wiring 113, and an insulating layer 114, and possesses not only elasticity and flexibility but also adhesion to the human body 11 (see Figures 5 to 7). Therefore, the sensor sheet 101 can be made to adhere closely to the abdominal region 12 corresponding to the transversus abdominis muscle, which is the target of electromyography measurement.

[0083] From the sensor sheet 101, which is in close contact with the abdomen 12, electrical signals of muscle potential generated by the transversus abdominis muscle can be extracted via the electrodes 112. The electromyogram generation unit 131A then generates electromyogram image data showing the activity status of the transversus abdominis muscle based on the electrical signals extracted from the sensor sheet 101, and displays the electromyogram based on the generated image data on the monitor 172.

[0084] Since the transversus abdominis muscle contracts in conjunction with the pelvic floor muscles, the activity level of the pelvic floor muscles can be estimated by referring to the electromyogram of the transversus abdominis muscle displayed on monitor 172.

[0085] (2) Second process The synergistic contraction of the pelvic floor muscles and the transversus abdominis muscle does not occur with 100% probability (see Non-Patent Literature 1, page 88, "3-8-2"). While it is presumed that there is a causal relationship between the synergistic contraction of the pelvic floor muscles and the transversus abdominis muscle, this causal relationship is not clear, and even if it were clear, it would be difficult to convey this in words and allow the person to experience it. Therefore, the bio-information acquisition method of this embodiment uses ultrasound to observe the activity of the bladder, which can be identified with the contraction movement of the pelvic floor muscles, while observing the activity of the transversus abdominis muscle using electromyography.

[0086] In the second step, in order to acquire an ultrasound image of the bladder, the ultrasound sensor 201 is pressed against the abdomen 12 so that the ultrasound probe 202 is placed on the sensor sheet 101 attached to the abdomen 12.

[0087] The echo image generation unit 211A generates ultrasound echo image data based on the ultrasound echo signal output by the ultrasound probe 202, and displays the ultrasound echo image (M-mode image) based on the generated image data on the monitor 272.

[0088] Monitor 272 displays motion images of the bladder. The condition of the bottom of the bladder directly reflects the activity of the pelvic floor muscles, so by referring to the ultrasound images displayed on Monitor 272, it is possible to confirm whether the pelvic floor muscles are contracting in coordination with the transverse abdominal muscles.

[0089] (3) Summary The ultrasonic sensor 201 acquires an ultrasound image of the bladder by placing the ultrasonic probe 202 on a sensor sheet 101 attached to the abdomen 12. This is possible because the ultrasound emitted from the transducer array 203 of the ultrasonic probe 202 propagates through the inside of the sensor sheet 101 to reach the bladder (see Figure 1(B)(C)), reflects off the bladder, and then propagates again through the inside of the sensor sheet 101 to return to the transducer array 203. In other words, this is due to the ultrasonic propagation property of the sensor sheet 101.

[0090] It is presumed that the property of transmitting ultrasonic waves is obtained because elastomers, particularly urethane-based elastomers, are used as the materials for the components of the sensor sheet 101: the sheet 111, the electrode 112, the wiring 113, and the insulating layer 114. It is also presumed that the thickness of the sheet 111 and the insulating layer 114 being 50 μm or less, for example, 10 to 25 μm or less, and that the electrode 112 and the wiring 113 are produced by a printing method, also contribute to giving the sensor sheet 101 the property of transmitting ultrasonic waves.

[0091] 6. An example of a different image generation unit The electromyogram generation unit 131B, another example of an image generation unit, will be described based on Figure 10, and the echo image generation unit 211B will be described based on Figure 11. Parts identical to those described in Figure 8 for the electromyogram generation unit 131A and Figure 9 for the echo image generation unit 211A are indicated by the same reference numerals, and their descriptions are omitted.

[0092] The biological information acquisition device BIA-B of this embodiment includes an electromyogram generation unit 131B and an echo image generation unit 211B.

[0093] (1) Electromyogram generation unit The electromyogram generation unit 131B connects a communication control circuit 181 to the main control unit 151 and the analysis processing unit 137, instead of the display control circuit 171. The communication control circuit 181 is equipped with a communication interface (not shown) that performs at least one of wired communication and wireless communication according to a specific communication protocol. Upon receiving a command from the main control unit 151, the communication control circuit 181 transmits the video data of the electromyogram received from the analysis processing unit 137 to an external device (not shown).

[0094] The analysis processing unit 137 of the electromyogram generation unit 131B edits the electromyogram image data into a format that can be played back by media player software, which is used for video playback. The main control unit 151 sends a control command to the analysis processing unit 137, causing it to output the generated electromyogram video data to the communication control circuit 181. The communication control circuit 181 receives a command from the main control unit 151 and transmits the electromyogram video data received from the analysis processing unit 137 via wired or wireless communication.

[0095] If the communication control circuit 181 is equipped with a wired communication interface, and an information device that supports a common communication protocol and has a media player installed, such as a personal computer (not shown), is connected to the communication control circuit 181, the electromyogram video data generated by the analysis processing unit 137 will be transmitted to the personal computer. The personal computer can then play the received electromyogram video data using a media player and display it on a display (not shown).

[0096] If the communication control circuit 181 is equipped with a wireless communication interface, it is possible to play back the electromyogram video data wirelessly transmitted by the communication control circuit 181 on an information device that supports a common communication protocol and has a media player installed, such as a smartphone or tablet.

[0097] (2) Echo image generation unit The echo image generation unit 211B connects a communication control circuit 281 to the main control unit 251 and the image processing unit 244, instead of the display control circuit 271. The communication control circuit 281 is equipped with a communication interface (not shown) that performs at least one of wired communication and wireless communication according to a specific communication protocol. Upon receiving a command from the main control unit 251, the communication control circuit 281 transmits the video data of the ultrasound echo received from the image processing unit 244 to an external device (not shown).

[0098] The image processing unit 244 of the echo image generation unit 211B edits the image data of the ultrasound echo into a format that can be played back by media player software, which is used for video playback. The main control unit 251 sends a control command to the image processing unit 244, causing it to output the generated ultrasound echo video data to the communication control circuit 281. The communication control circuit 281 receives a command from the main control unit 251 and transmits the ultrasound echo video data received from the image processing unit 244 via wired or wireless communication.

[0099] If the communication control circuit 281 is equipped with a wired communication interface, and an information device that supports a common communication protocol and has a media player installed, such as a personal computer (not shown), is connected to the communication control circuit 281, the video data of the ultrasound echo generated by the image processing unit 244 will be transmitted to the personal computer. The personal computer can then play the received video data of the ultrasound echo using a media player and display it on a display (not shown).

[0100] If the communication control circuit 281 is equipped with a wireless communication interface, it is possible to play back the video data of the ultrasound echo wirelessly transmitted by the communication control circuit 281 on an information device that supports a common communication protocol and has a media player installed, such as a smartphone or tablet.

[0101] (3) Display method Regarding electromyography (EMG), three viewing methods were introduced: viewing on monitor 172, viewing on wired devices such as personal computers, and viewing on wireless devices such as smartphones and tablet terminals. Similarly, three viewing methods were introduced for ultrasound echoes: viewing on monitor 272, viewing on wired devices such as personal computers, and viewing on wireless devices such as smartphones and tablet terminals. In total, there are six viewing methods.

[0102] These six methods of browsing can be combined and applied as appropriate.

[0103] For example, various viewing methods are acceptable, such as viewing electromyograms on monitor 172 and ultrasound images on a smartphone, or viewing both electromyograms and ultrasound images on computer displays placed side by side. When implementing the program, instructors and practitioners of pelvic floor muscle exercises should appropriately select a viewing method that is easy to see and understand.

[0104] 7. An example of a different image generation unit

[0105] Another example of the image generation unit (electromyogram generation unit 131C, echo image generation unit 211C) will be described with reference to Figure 12. This embodiment is based on the image generation unit (electromyogram generation unit 131A, echo image generation unit 211A) described with reference to Figures 8 and 9. Therefore, the same parts as in the first embodiment described with reference to Figures 8 and 9 are indicated by the same reference numerals and their descriptions are omitted.

[0106] In this embodiment, the electromyogram generation unit 131A and the echo image generation unit 211A are integrated, and their respective main control units 151 and 251 are combined into a single main control unit 351. Furthermore, the display control circuits 171 and 271 are combined into a single display control circuit 371, and the monitors 172 and 272 are combined into a single monitor 372.

[0107] Therefore, the electromyogram image data generated by the analysis processing unit 137 is sent to the display control circuit 371 by command from the main control unit 351, and is displayed on the monitor 372 as an electromyogram according to the display control of the display control circuit 371. Similarly, the ultrasound echo image data (M-mode image) generated by the image processing unit 244 is sent to the display control circuit 371 by command from the main control unit 351, and is displayed on the monitor 372 as an ultrasound echo according to the display control of the display control circuit 371.

[0108] At this time, the display control circuit 371, in accordance with the command from the main control unit 351, edits the electromyography image data and the ultrasound echo image data into a single screen of integrated data with synchronized time axes. On the monitor 372, the electromyography and ultrasound echo are displayed side by side, for example, vertically, with the same time axis.

[0109] Therefore, since the electromyogram and ultrasound echo are displayed on the same time axis within a single screen of the monitor 372, it becomes easier to confirm whether the pelvic floor muscles are contracting along with the transversus abdominis muscle.

[0110] 8. Another example of the image generation unit Another example of the image generation unit (electromyogram generation unit 131D, echo image generation unit 211D) will be described based on Figure 13. This embodiment is based on the image generation unit (electromyogram generation unit 131B, echo image generation unit 211B) described based on Figures 10 and 11. Therefore, the same parts as those in the second embodiment described based on Figures 10 and 11 are indicated by the same reference numerals, and their descriptions are omitted.

[0111] In this embodiment, the electromyogram generation unit 131B and the echo image generation unit 211B are integrated, and their respective main control units 151 and 251 are combined into a single main control unit 351. Furthermore, the communication control circuits 181 and 281 are combined into a single communication control circuit 381.

[0112] Therefore, the electromyogram image data generated by the analysis processing unit 137 is sent to the communication control circuit 381 by command from the main control unit 351 and transmitted to an external device (not shown) as video data of the electromyogram that can be viewed by a media player. Similarly, the ultrasound echo image data (M-mode image) generated by the image processing unit 244 is sent to the communication control circuit 381 by command from the main control unit 351 and transmitted to an external device (not shown) as video data of the ultrasound echo that can be viewed by a media player.

[0113] At this time, the communication control circuit 381, in accordance with the command from the main control unit 351, edits the electromyography image data and the ultrasound echo image data into a single integrated data set with synchronized time axes.

[0114] On external devices that receive the integrated data, such as personal computers or smartphones, the electromyogram and ultrasound images are displayed side-by-side, for example, vertically, on the same time axis, via a media player.

[0115] Therefore, since the electromyogram and ultrasound echo are displayed on the same time axis on a single display screen of the external device, it becomes easier to confirm whether the pelvic floor muscles are contracting along with the transversus abdominis muscle.

[0116] 9. Variations Various modifications and changes are permitted during implementation.

[0117] For example, regarding the sensor sheet 101, specific shapes, various numerical values, and manufacturing methods have been shown for each part, such as the sheet 111, electrodes 112, and wiring 113. However, these are merely one form of implementation, and various modifications and changes may be made during implementation.

[0118] Furthermore, in the biological information acquisition devices BIA-A to D, an example was shown in which the sensor sheet 101, which serves as the biological information acquisition sensor BIS, and the electromyogram generation units 131A to D are connected by connectors CN1 and CN2. However, in actual implementation, connectors CN1 and CN2 are not necessarily required. For example, the connection lines 115 extending from the sensor sheet 101 may be directly connected to the two buffer amplifiers 132 and 133 and the one differential amplifier 134.

[0119] Furthermore, the electromyogram generation units 131A to D may be housed entirely within a single housing, or they may be distributed and housed in multiple housings.

[0120] This also applies to the echo image generation units 211A to D. For example, the ultrasonic sensor 201 may contain only the ultrasonic probe 202 in the housing as illustrated in Figure 4, or it may also contain other circuits such as the echo signal transmission / reception circuit 231 and the signal processing unit 242.

[0121] Any changes or modifications are permitted during implementation. [Examples]

[0122] The inventors of this application conducted experiments to verify whether the sensor sheet transmits ultrasound waves and whether ultrasound images showing bladder movement can be obtained normally even from above the sensor sheet. The details of the experiment and its results are reported below based on Figures 14(A)(B) to 18.

[0123] 1. Experiments using a phantom (1) Experimental apparatus As shown in Figures 14(A) and (B), a phantom was used in the experiment, and an ultrasonic probe was used to acquire images (M-mode images) of the ultrasonic echoes inside the phantom. The results were compared with and without a sensor sheet (see Figure 14(A)) to verify the extent to which the sensor sheet affects the ultrasonic echo images.

[0124] The phantom used in the experiment was the US-2 ultrasonic evaluation phantom manufactured by Kyoto Kagaku Co., Ltd. This phantom contains three wires. In Figures 14(A) and 14(B), the three wires are shown as black dots arranged in a vertical line.

[0125] The sensor sheet, or biopotential sensor, used was a stretchable FPC (Flexible Printed Circuits) manufactured by Nippon Mectron Co., Ltd.

[0126] For the ultrasound probe, we used the "VSCAN Air" (product name), a convex-type ultrasound probe manufactured by GE Healthcare Japan Corporation.

[0127] In addition, the experiment also used ultrasound gel and EMG cream. The ultrasound gel used was "F JELLY PLUS" (product image) manufactured by Fujifilm Corporation. For the EMG cream, Kenz's EMG cream was used.

[0128] (2) Experimental results Figure 14(A) shows an example of an experiment (comparative experiment) that does not use a sensor sheet.

[0129] In this experiment, an ultrasound gel was applied to the phantom, and an ultrasound probe was placed on top of it to irradiate the phantom with ultrasound. In Figure 14(A), the image above the words "M-mode" is an M-mode image of an ultrasound echo acquired by the ultrasound probe at a specific moment. Three wires can be seen appearing in white.

[0130] Figure 14(B) shows an example of an experiment (verification experiment) using a sensor sheet.

[0131] In this experiment, EMG cream was applied to the phantom, and a sensor sheet was attached on top of it. Ultrasound gel was applied to the sensor sheet, and an ultrasound probe was placed on top of it to irradiate the phantom with ultrasound. In Figure 14(B), the image above the words "M-mode" is an M-mode image of an ultrasound echo acquired by the ultrasound probe at a specific moment. Three wires can be seen appearing in white.

[0132] Figure 15(A) is a schematic diagram showing an echo image obtained in a comparative experiment. It is a snapshot taken at a specific moment from an M-mode image without a sensor sheet.

[0133] Figure 15(B) is a schematic diagram showing an echo image obtained in a verification experiment. It is a snapshot of a specific moment taken from an M-mode image of ultrasound propagating through the sensor sheet.

[0134] Comparing the image in Figure 15(A) with the image in Figure 15(B), the latter ultrasound image is darker overall than the former, but no significant decrease in quality is observed, and it was confirmed that an image of sufficient quality for visible evaluation within the body can be obtained.

[0135] Figure 16 is a graph showing the waveform of the echo intensity obtained during the experiment shown in Figures 14(A) and (B). The echo intensity is the voltage (mV) output by the transducer array of the ultrasonic probe.

[0136] In Figure 16, the echo intensity in the comparative experiment without using a sensor sheet (see Figure 14(A)) is shown by a solid line. The echo intensity in the verification experiment using a sensor sheet (see Figure 14(B)) is shown by a dotted line.

[0137] As can be seen from the graph in Figure 16, there is no significant difference in echo intensity when using a sensor sheet compared to when not using one. Therefore, from the perspective of echo intensity, it has been proven that images sufficient for visible evaluation within a living organism can be obtained even from ultrasound echo signals acquired via a sensor sheet.

[0138] 2. Experiments using the human body (1) Experimental apparatus Similar to the embodiment, electromyography of the transversus abdominis muscle (see Figure 2) and ultrasound measurement of the abdomen were performed simultaneously. The sensor sheet, ultrasound probe, ultrasound gel, and EMG cream used in the experiment were the same as those used in "1. Experiment using a phantom" in the previous section.

[0139] In experiments using human subjects, we conducted both experiments without sensor sheets (comparative experiments) and experiments with sensor sheets (verification experiments).

[0140] In the comparative experiment, ultrasound gel was applied to the abdominal region corresponding to the transversus abdominis muscle, and an ultrasound probe was placed on top of it to acquire ultrasound signals.

[0141] In the verification experiment, EMG cream was applied to the abdominal area corresponding to the transverse abdominis muscle, and a sensor sheet was attached on top of it. Then, ultrasound gel was applied on top of the sensor sheet, and an ultrasound probe was placed over it to acquire ultrasound echoes. At this time, electromyographic signals were acquired from the sensor sheet.

[0142] (2) Experimental results Figures 17(A) and (B) show ultrasound images obtained in a comparative experiment, extracted from M-mode images at a specific moment. (A) is an image of muscle relaxation, and (B) is an image of muscle contraction. The dark area in the center is the bladder, and by observing the state of the bottom of the bladder, it is possible to understand the movement state of the pelvic floor muscles located below it.

[0143] Figures 17(C) and (D) show ultrasound images obtained in the verification experiment, extracted from M-mode images at a specific moment. (C) shows the image during muscle relaxation, and (D) shows the image during muscle contraction. Even in the ultrasound images obtained in the verification experiment, the bladder changes shape, and the displacement of its base can be clearly seen. Therefore, it is possible to understand the movement state of the pelvic floor muscles located below the base of the bladder.

[0144] Figure 18 is a graph showing the muscle contraction timing from Figures 17(C) and 17(D) superimposed on electromyogram images obtained from the verification experiment. The horizontal axis represents time (10 to 30 seconds), and the vertical axis represents the voltage value (-20 to 20 μV), which indicates the magnitude of the electromyogram.

[0145] As shown in Figure 18, the voltage value fluctuates in accordance with the increase or decrease in electromyography (EMG) acquired from a sensor sheet attached to the abdominal region corresponding to the transversus abdominis muscle. The intervals in which the voltage value is high indicate intervals in which the transversus abdominis muscle is contracting. Muscle contraction in the transversus abdominis muscle generally occurs in the intervals of approximately 10-11.5 seconds, 13.5-16 seconds, 19-20 seconds, 23.5-26 seconds, and 28.5-30 seconds.

[0146] In Figure 18, the intervals indicated by double arrows and labeled "contraction" represent the intervals in which displacement of the bladder base, as observed from ultrasound images, occurred, i.e., pelvic floor muscle contraction. From the graph in Figure 18, it can be confirmed that, with the exception of the interval from 28.5 to 30 seconds, the contraction of the transversus abdominis muscle and the contraction of the pelvic floor muscles occur at almost the same time. At this timing, pelvic floor muscle exercises are being performed correctly.

[0147] In contrast, around 27 seconds, the voltage value indicating contraction of the transverse abdominal muscle momentarily increases, and contraction of the pelvic floor muscles occurs in the 27-29 second range. However, during this time, until approximately 28.5 seconds, the voltage value indicating contraction of the transverse abdominal muscle decreases. After 28.5 seconds, the voltage value increases, and at 29 seconds, the contraction of the pelvic floor muscles subsides. From these measurement results, it can be inferred that in the 27-30 second range, the pelvic floor muscles do not contract as intended by the person performing the pelvic floor exercises. [Explanation of Symbols]

[0148] 11 human body 12 Abdomen 101 Sensor Sheet 111 seats 112 Electrode 113 Wiring 113a Output end 114 Insulating layer 115 connecting line 131A, 131B, 131C, 131D Electromyography generation unit (image generation unit) 132,133 Buffer Amplifier 134 Differential Amplifier 135 filters 136 Amplifier 137 Analysis Processing Unit 151 Main Control Unit 171 Display control circuit 172 monitors 181 Communication control circuit 201 Ultrasonic Sensor 202 Ultrasound probe 203 Oscillator Array 211A, 211B, 211C, 211D Echo Image Generation Unit (Image Generation Unit) 231 Echo signal transmission and reception circuit 232 Pulse Generator 233 Amplifier 234 AD Converters 235 Beamformer 241 Ultrasound Image Generation Unit 242 Signal Processing Unit 243 DSC 244 Image Processing Unit 251 Main Control Unit 271 Display Control Circuit 272 monitors 281 Communication control circuit 351 Main Control Unit 371 Display Control Circuit 372 monitors 381 Communication control circuit BIA-A, BIA-B, BIA-C, BIA-D Biometric Information Acquisition Devices BIS (Biometric Information Acquisition Sensor) CN1, CN2 connectors

Claims

1. A sensor sheet attached to the human body to acquire electrical signals generated by muscles, An ultrasonic sensor having an ultrasonic probe that is applied to the sensor sheet attached to the human body, and which receives ultrasonic echo signals from the human body, Equipped with, The aforementioned sensor sheet is A sheet made of elastomer, A plurality of electrodes provided on the aforementioned sheet, made of an elastomer material to which conductivity has been imparted, Multiple wires, each connected to the electrodes and provided on the sheet, are made of an elastomer material to which conductivity has been imparted, An insulating layer made of elastomer is fixed to the sheet so as to cover the wiring while leaving the electrode portion untouched, Equipped with, Biometric information acquisition sensor.

2. The sensor sheet is attached to the abdominal region corresponding to the transversus abdominis muscle, and receives electrical signals generated by the transversus abdominis muscle via the electrodes. The ultrasonic sensor receives an ultrasonic echo signal including the bottom of the bladder. A biological information acquisition sensor according to claim 1.

3. The elastomer used as the material for the sheet, the electrode, the wiring, and the insulating layer is urethane-based. A biological information acquisition sensor according to claim 1.

4. The thickness of the aforementioned sheet is 50 μm or less. A biological information acquisition sensor according to claim 1.

5. A biological information acquisition sensor according to any one of claims 1 to 4, An electromyogram generation unit generates electromyogram image data based on an electrical signal taken from the output terminal of the wiring of the sensor sheet, An echo image generation unit generates ultrasound echo image data based on the ultrasound echo signal output by the ultrasound probe of the ultrasound sensor, A biological information acquisition device equipped with the following features.

6. A biological information acquisition sensor according to any one of claims 1 to 4, An image generation unit that performs image generation processing based on the output signal of the biological information acquisition sensor, Equipped with, The image generation unit, Based on the electrical signal extracted from the output terminal of the wiring of the sensor sheet, electromyogram image data is generated. Based on the ultrasonic echo signal output by the ultrasonic probe of the ultrasonic sensor, the ultrasonic echo image data is generated. A device for acquiring biological information.

7. The image generation unit, The electromyography image data and the ultrasound echo image data are edited together as integrated data on a single screen with synchronized time axes. The biological information acquisition device according to claim 6.

8. A method for acquiring biological information using the biological information acquisition sensor described in claim 1, The aforementioned sensor sheet is attached to the abdominal region corresponding to the transverse abdominis muscle. The ultrasonic sensor is pressed against the abdomen so that the ultrasonic probe is placed on the sensor sheet attached to the human body. Methods for acquiring biometric information.

9. The elastomer used as the material for the sheet, the electrode, the wiring, and the insulating layer is urethane-based. The method for obtaining biological information according to claim 8.

10. The thickness of the aforementioned sheet is 50 μm or less. The method for obtaining biological information according to claim 8.

11. Based on the electrical signal extracted from the output terminal of the wiring of the sensor sheet, electromyogram image data is generated. Based on the ultrasonic echo signal output by the ultrasonic probe of the ultrasonic sensor, the ultrasonic echo image data is generated. A method for acquiring biological information according to any one of claims 8 to 10.

12. Based on at least one of the electromyography image data and the ultrasound echo image data, an image is displayed on a monitor. The method for acquiring biological information according to claim 11.

13. At least one of the electromyography image data and the ultrasound echo image data is edited into video data that can be played back by a media player. The aforementioned video data is transmitted and output to an external source. The method for acquiring biological information according to claim 11.

14. The electromyography image data and the ultrasound echo image data are edited together as integrated data on a single screen with synchronized time axes. The method for acquiring biological information according to claim 11.

15. Based on the aforementioned integrated data, an image is displayed on the monitor. The method for acquiring biological information according to claim 14.

16. The aforementioned integrated data is edited into video data that can be played by a media player. The aforementioned video data is transmitted and output to an external source. The method for acquiring biological information according to claim 14.