Biometric information acquisition device

Abstract

The present invention provides a biological information acquisition device or method for acquiring electrocardiogram information and blood flow-related information that can acquire biological information without reducing the accuracy of intestinal measurements and without ensuring the reproducibility of measurement values, regardless of the type of stool or foreign object being measured. [Solution] A biological information acquisition device comprising a measuring unit, a processing unit for performing calculations on data obtained by measurement, and an output unit for outputting the calculation data from the processing unit as a signal, wherein the measuring unit is provided with an optical sensor and a temperature sensor arranged close to each other in an installation area in a specific circumferential direction of the flexible shaft, and a strip-shaped or cap-shaped cleaning cover is provided on the shaft head of the flexible shaft, excluding the specific circumferential direction, for cleaning by contacting the inner wall of the body cavity.

Description

Technical Field

[0001] The present invention relates to a biological information acquisition device that acquires and displays biological information for each individual of target animals including humans, animals, and livestock, and a method for acquiring the biological information. In particular, it includes domestic animals such as dogs and cats, and livestock animals such as cows and horses as target animals, and relates to a device (intracavitary insertion device) that inserts into the anus, vagina, nasal cavity, oral cavity, ear (referred to as "body cavity") of these target animals to acquire biological information inside the body. Regarding the biological information, in particular, electrocardiogram waveform information (such as P wave, QRS wave, presence or absence of arrhythmia, movement of myocardium, etc.) or blood pressure-related information (pulse pressure, propagation time to the measurement site, hardness of blood vessels, stenosis / plaque volume of blood vessels, blood flow volume / blood flow velocity, information on changes in blood pressure based on these (short-term temporal changes), and blood pressure), in addition to sound and vibration, and relates to a device and method for detecting these biological information with a sensor or estimating from the detected values.

Background Art

[0002] Conventionally, as a system and method for evaluating global perfusion insufficiency in a patient, those including a surface perfusion pressure monitor and a blood pressure monitor have been disclosed (Patent Document 1, Japanese Patent Publication No. 2007-525253). This surface perfusion pressure monitor may include a Doppler sensor or a photoplethysmogram. A surface perfusion index, or alternatively, an optical plethysmography index is derived from surface perfusion pressure measurement and blood pressure measurement to enable evaluation of global perfusion insufficiency. In an alternative embodiment, a blood flow sensor may be added to this system and is adjacent to a mucosal surface accessible by the mouth or nose connected to the patient's gastrointestinal tract or upper airway / upper digestive tract to measure sublingual gland PCO2 and SaO2. A pH sensor may be used in combination with blood flow determination.

[0003] In the aforementioned system, the measurement of surface perfusion pressure is made more accurate by using a reference measurement of blood pressure. Blood pressure can be measured at the upper arm, toes and thigh, or directly via an arterial line inserted into an available artery, and the measurement of surface perfusion pressure is divided by the blood pressure measurement to calculate a resulting index, which is called the SPP index (0045).

[0004] In addition to the above, a wearable device for measuring tympanic membrane temperature has been disclosed as a monitor for acquiring physiological information such as blood pressure and body temperature (see Patent Document 2, Japanese Patent No. 7255906). This wearable device includes an ear insertion portion, which is provided by a thermocouple array module configured to measure tympanic membrane temperature during use, a wired electrical connection portion extending through the ear insertion portion for outputting a signal from the infrared thermocouple array during use, and an acoustic passage at least partially defined within the ear insertion portion.

[0005] In addition to the above, a digital rectal thermometer is disclosed. This thermometer is inserted into the rectum to measure the temperature of the rectal wall in contact with it, and is used in the examination of corpses and patients with severe body temperature abnormalities, considering that the inside of the anus is less affected by the outside air and is said to measure the temperature closest to body temperature. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] Special Publication No. 2007-525253 [Patent Document 2] Patent No. 7255906 [Disclosure of the Invention] [Problems that the invention aims to solve]

[0007] Here, it is conceivable to equip a digital thermometer for rectal use with an optical sensor and acquire information on the temperature and blood flow of the rectal wall using the temperature sensor and optical sensor in contact with the rectal wall.

[0008] However, the rectum is often contaminated with or filled with feces and other waste, and depending on the condition of the rectum, the optical sensor may not function properly. If the optical sensor includes areas containing waste in its detection range, the optical properties will differ significantly from those of the rectum. This could lead to misinterpretations, such as misidentifying reflected ultrasound waves as waves of different wavelengths and amplitudes to determine blood flow status or depth, or misinterpreting extremely low heart rate or pulse rate. These issues can affect the reliability of the rectal insertion detection method itself, which is supposed to acquire biological information with high accuracy.

[0009] Therefore, the objective of this invention is to provide a rectal insertion type detection device that can accurately function even when the rectum is in a state such as when feces or other waste are attached to or retained in the rectum, and can acquire biological information with high accuracy. [Means for solving the problem]

[0010] To address the above issues, the following measures have been taken. Note that the numbers or strings of numbers and letters following the component names below are symbols used for convenience to understand the components in the drawings and do not inherently contain any meaning or limitation.

[0011] [1] The biological information acquisition device of the present invention is It consists of a rod-shaped flexible shaft that is inserted into the body cavity of the target animal through an opening such as the intestines, vagina, mouth, nose, or ears, and a measuring unit (1) that measures biological information of the insertion site by a group of sensors located in a specific installation area near the tip of the shaft head, A biological information acquisition device comprising a processing unit (2) that performs calculations on data obtained by measurement, and an output unit (21) that outputs the calculation data from the processing unit as a signal, The measurement unit (1) is equipped with a group of sensors (a combination of multiple optical sensors S2, temperature sensors S1, sound wave sensors, radio wave sensors, infrared sensors, electromagnetic wave sensors, electrocardiogram electrodes, vibration sensors, and image sensors) arranged in close proximity to each other within a specific installation area on a specific circumferential side of the flexible shaft or on the shaft head at the tip, which contacts the wall of the body cavity to which it is inserted (internal wall, e.g., rectal wall) to detect detected values ​​and measure biological information. The flexible shaft is characterized by having a "cleaning cover (3)" consisting of a strip-shaped or cap-shaped cover body around the shaft head, excluding the aforementioned specific installation area. The cleaning cover (3) covers the area of ​​the shaft head that includes the axial range of the installation area of ​​the flexible shaft portion 12 and excludes the installation areas of the optical sensor S2 and the temperature sensor S1. It is a strip-shaped or cap-shaped cover body that contacts and cleans the inner wall of the body cavity and has a cleaning function on its surface. This cleaning cover 3 contacts the wall of the body cavity to which it is inserted and cleans away any lumpy or membrane-like foreign matter, removing it from the body cavity wall within the detection range of the detection unit.

[0012] [2] The installation area equipped with each sensor is a closed, horizontally or vertically elongated, flattened circular installation area. The cleaning cover (3) is made of a napped brush or a cleaning cloth and has a window portion 3H that conforms to the shape of the flat circular installation area. Clean the area around window section 3H with a brush or cleaning cloth, The invention is characterized in that multiple sensors are arranged axially at various positions on the rod axis of a rod-shaped flexible shaft within the window portion 3H, and detect the body cavity wall surface either in contact with it or without contact.

[0013] The window section 3H may be left open, or a portion of the window section 3H may be covered with a translucent sheet.

[0014] [3] In any of the above-described biological information acquisition devices, the cleaning cover (3) consists of a cap-shaped or ring-shaped circumferential attachment that is mounted around the entire circumference within a predetermined axial range at the tip of the flexible shaft, and can be released and removed from the flexible shaft by deforming the cap-shaped or ring-shaped form of the circumferential attachment. Furthermore, by selecting and attaching one of a plurality of pre-provided cleaning covers and then releasing it, other cleaning covers can be replaced and attached.

[0015] [4] In any of the above-described biological information acquisition devices, the shaft head at the tip of the flexible shaft is equipped with a light-emitting irradiation unit that emits light around the outside of the shaft and illuminates the surroundings, and an imaging camera, The flexible shaft is characterized by having a group of sensors consisting of multiple combinations of optical sensors, temperature sensors, sound wave sensors, radio wave sensors, infrared sensors, electromagnetic wave sensors, electrocardiogram electrodes, and image sensors in the installation area on the side surface.

[0016] Furthermore, the system is characterized by illuminating the area around the shaft with a light-emitting unit while capturing images of the illumination range with an imaging camera, and acquiring measurement values ​​with each sensor in the sensor group, thereby outputting the measurement values ​​acquired simultaneously with the imaging data of the illuminated state inside the body cavity to the output unit along with the image of the imaging data.

[0017] Alternatively, the optical sensor and temperature sensor may detect measured values ​​simultaneously with the emission of light, camera imaging, and the discharge of cleaning solution. Based on these detected values, the presence or absence of an abnormal measurement state may be determined, and this determination result, along with the detected values ​​from each sensor, may be output as calculated data to the output unit.

[0018] [5] A biological information acquisition device as described above, characterized in that the tip of the shaft is made of a transparent or translucent cover, and the light-emitting irradiation unit is built inside the cover at the tip of the shaft.

[0019] [6] In the biological information acquisition device according to any one of the above, a cleaning liquid injection nozzle is provided on the front side of the installation area provided with each sensor and the installation areas of the optical sensor S2 and the temperature sensor S1, and a cleaning liquid delivery device communicated through an internal liquid pipe is provided. Along with the delivery of the cleaning liquid, each sensor of the optical sensor and the temperature sensor detects a measured value, determines the presence or absence of an abnormal measurement state based on the detected value, and outputs a signal to the output unit as the arithmetic data together with the detected value of each sensor.

[0020] The processing unit determines the presence or absence of an abnormal measurement state based on the detected values of each sensor of the optical sensor and the temperature sensor, and outputs a signal to the output unit as the arithmetic data together with the detected value of each sensor.

[0021] [7] In the biological information acquisition device according to any one of the above, it further includes a notification unit connected by wire or wirelessly to the flexible shaft. The notification unit receives the arithmetic data signal - output by the output unit through a wired or wireless connection, displays the sensor detection value, and notifies the discrimination result of the abnormal measurement state by means of sound, light, or display.

[0022] [8] In the biological information acquisition device according to any one of the above, it includes an optical sensor having a continuous - intermittent measurement function for intermittently or continuously measuring information on the blood flow (oxygen saturation or tissue oxygen saturation) of the tissue within the body cavity wall over a predetermined period of time. By this optical sensor, the continuous - intermittent measured values of the blood flow information are stored together with a time code, and it is determined whether the continuous - intermittent measured values fall within a predetermined threshold range of a certain fluctuation pattern, and the waveform disturbance due to body movement or posture change is discriminated.

[0023] [9] A biological information acquisition device according to any of the above-mentioned descriptions, characterized in that a measuring surface is formed by creating a plane or a gently curved surface in a specific circumferential direction of the flexible shaft, and a blood flow sensor targeting the blood flow component of the inner wall of the body cavity, a sensor for detecting the temperature or pressure inside the body cavity, and a tip illumination light-emitting unit are arranged in close proximity in the axial direction on this measuring surface.

[0024]

[10] The device is characterized by a tip bulge consisting of a convex rotating body or elongated spherical shaft head, which incorporates a sensor group consisting of a combination of multiple types of sensors from among optical sensors, temperature sensors, sound wave sensors, radio wave sensors, infrared sensors, electromagnetic wave sensors, electrocardiogram electrodes, and image sensors, and a rod-shaped shaft portion, which are joined together by an attachment structure or are detachably combined. [Effects of the Invention]

[0025] By implementing the aforementioned measures, it became possible to perform more accurate and precise measurements by wiping the area around the measurement unit with a cleaning cover to remove feces and other contaminants before detection.

[0026] Furthermore, by making the cleaning cover replaceable, or even the shaft itself replaceable, it is possible to suppress the occurrence of hygiene problems such as infection from bacteria attached to the device from within the body.

[0027] In particular, by composing the cylindrical surface of the cleaning cover with a brushed or absorbent cloth that has water-absorbing properties, it is possible to remove waste from the intestines while absorbing water and wiping the intestinal wall surface, and by detecting the wiped intestinal wall surface immediately afterward, measurements can be taken without being affected by wiping or removal. [Brief explanation of the drawing]

[0028] [Figure 1] Diagram illustrating the configuration example of the biological information acquisition device and its data processing system according to Example 1. [Figure 2] Example of the separation configuration of the shaft head of the biometric information acquisition device and the configuration of replacement parts. [Figure 3]Example configuration of the separation configuration of the shaft head of the biological information acquisition device in Example 2 [Figure 4] Examples of the states (a), (b), (c), and (d) of the biological information acquisition device in Example 3 before and after the installation of the cleaning cover. [Figure 5] Example of the separation configuration of the shaft head and the configuration of replacement parts of the biological information acquisition device in Example 4 [Figure 6] Example of the separation configuration of the shaft head and the configuration of replacement parts of the biological information acquisition device in Example 5 [Figure 7] Diagram illustrating the overall configuration of the biological information acquisition device of Example 6, which is equipped with a cleaning device. [Figure 8] Figure 7: Cross-sectional view of the main part [Figure 9] Figure 8 shows the state during cleaning (a) and the normal state (b) in the enlarged section of part AA. [Figure 10] Examples of usage status of the biological information acquisition device of Example 1 (a)(b) [Modes for carrying out the invention]

[0029] The following describes examples of embodiments for carrying out the present invention, along with the figures shown as examples. The present invention provides a biological information acquisition device that is inserted into the anus, vagina, nasal cavity, oral cavity, or ear ("body cavity") of a target animal to detect biological information within the body, and calculates or estimates and outputs measured values ​​based on the detected values. The target animals include domesticated animals such as dogs and cats, and livestock animals such as cattle and horses. The aforementioned biological information includes electrocardiogram waveform information (e.g., P wave, QRS wave, presence or absence of arrhythmia, myocardial movement, etc.) or blood pressure-related information (pulse pressure, propagation velocity to the measurement site, vascular stiffness, vascular blockage / plaque volume, blood flow rate / blood flow velocity, information on changes in blood pressure based on these (short-term time changes), and blood pressure), as well as sound and vibration information. (Device configuration) As a specific device configuration of the biological information acquisition device of the present invention, A measuring unit (1) consisting of a rod-shaped flexible shaft that is inserted into the body cavity of the target animal for measurement, A processing unit (2) that performs calculations on the data obtained by measurement, and an output unit (21) that outputs the calculation data from the processing unit as a signal, The measuring unit 1 comprises a cleaning cover (3) consisting of a cover body that covers the area around the shaft head of the flexible shaft, excluding the specific installation area. The measurement unit (1) has an installation area at the tip of the shaft head 11 at the end of the flexible shaft portion 12 and / or a side surface in a specific circumferential direction, and within this installation area, it is equipped with a group of sensors consisting of multiple types of sensors that contact the inner wall of a body cavity to detect values, with each detection unit arranged close to each other. The cleaning cover (3) consists of a strip-shaped or cap-shaped cover body that covers the "cover area" at the tip of the shaft head, excluding the installation area of ​​the sensor group's detection range, at an axial position in the axial direction of the installation area of ​​the flexible shaft portion 12 or in the axial direction before and after it. The sensor group cleans the inner wall of the body cavity by contacting it, and the detection units of the sensor group each contact the cleaned inner wall of the body cavity to detect and acquire biological information. The acquired biological information is converted into output data through calculation processing by the processing unit, and the signal is output to the output unit in the form of image data and audio data. The output unit is attached to or connected to the processing unit 2.

[0030] Furthermore, the method for acquiring biological information using the biological information acquisition device of the present invention is as follows: A device for acquiring biological information by inserting a flexible shaft into the body cavity of a target animal, such as the rectum or vagina. The steps include: wiping off any deposits on the wall of the body cavity to be inserted using a cleaning cover that covers a predetermined area of ​​the flexible shaft, thereby removing them from the detection range; The process involves acquiring primary biological information (at least one of the following: oxygen saturation, oxygen saturation waveform, tissue oxygen saturation, tissue oxygen saturation waveform, pulse rate, and body temperature) from the body cavity wall after cleaning, using a group of sensors located in the installation area on the side of a flexible shaft. The steps include: processing the acquired biological information as output information using a processing unit; The process involves performing each of the following steps sequentially or simultaneously: a step of outputting output information using an output unit; and a step of outputting output information using an output unit.

[0031] Furthermore, the method for acquiring biological information using a biological information acquisition device equipped with an issuing trading company department and an imaging camera at the tip of a flexible shaft includes a cleaning step.

[0032] Furthermore, a method for acquiring biological information using a biological information acquisition device equipped with a cleaning nozzle at the tip of a flexible shaft and a dispensing device that is electrically connected to it, involves a cleaning step.

[0033] (Cleaning cover) The cleaning cover 3 is composed of a cylindrical body having a napped brush or absorbent cloth on its surface, and the cylindrical body has a window portion 3H in a flat, circular shape that conforms to the installation area. The opening edge of window section 3H and the sides of the cylindrical body surrounding window section 3H are wiped clean with a fuzzy brush or cleaning cloth to absorb water, An optical sensor and a temperature sensor are positioned within the window section 3H.

[0034] Furthermore, the cleaning cover (3) consists of a cap-shaped or band-shaped circumferential attachment that is detachably mounted around the tip of the flexible shaft in the entire circumferential direction within a predetermined axial range, and multiple cleaning covers can be replaced.

[0035] Furthermore, as shown in Example 4 in Figure 5 and Example 5 in Figure 6, the tip cap of the bulging part at the end of the flexible shaft of the biological information acquisition device may have a light-emitting unit that emits light around the outside of the shaft, and an imaging camera, and the image captured inside the trading post may be displayed in real time on the output unit.

[0036] Furthermore, as shown in Example 4 in Figure 5 and Example 5 in Figure 6, in the biological information acquisition device, the shaft tip may be made of a transparent or translucent cover, and the light emission unit may be built into the shaft tip cover.

[0037] In any of the above-described biological information acquisition devices, the processing unit determines whether or not an abnormal measurement state is present based on the detected values ​​of the optical sensor and the temperature sensor, and outputs this determination result, along with the detected values ​​of each sensor, as calculation data to the output unit.

[0038] A biological information acquisition device according to any of the above, further comprising a notification unit connected by wire or wireless connection to the flexible shaft, The notification unit is characterized by receiving the calculation data signal output by the output unit via a wired or wireless connection, displaying the sensor detection value, and notifying the determination result of the abnormal measurement state by sound, light, or display notification means.

[0039] The sensors constituting the sensor group include, for example, a reflective pulse oxisensor 110S, a temperature sensor S1, and electrode terminals. Of these, the reflective pulse oxisensor 110S and the temperature sensor S1 together are referred to as the "biological information acquisition sensor".

[0040] (Measurement unit (biometric information acquisition device consisting of a flexible shaft 1)) The shaft head 11 at the tip of the flexible shaft portion 12 of the bio-information acquisition sensor has an ellipsoidal bulge shape. This measurement portion is inserted into the rectum, and the side of the measurement portion contacts the body cavity wall (e.g., the rectal wall, vaginal wall, or nasal cavity wall, ear cavity wall, or oral cavity wall). Sensor group (a combination of multiple of the following: optical sensor S2, temperature sensor S1, sound wave sensor, radio wave sensor, infrared sensor, electromagnetic wave sensor, electrocardiogram electrode, vibration sensor, and image sensor) More specifically, a rectal inserter is constructed by connecting a rod-shaped flexible shaft and an ellipsoidal, bulging measuring section at its end in a uniaxial direction. A detection unit is embedded in the side of the widest, most bulging part of this measuring section. It is made of an elastically deformable resin body, with a sensor embedded in a part of it. The casing of the processing unit is connected to the base of this rectal inserter either integrally or by a wired connection, and a detection signal from the detection unit or a current information signal from the contact of the electrode terminals is sent to the processing unit.

[0041] The measuring unit consists of a rod-shaped flexible shaft 1 that can be inserted into the rectum or vagina of the target animal, or into the ear or nose. A blood flow sensor (reflective pulse oxisensor) 110S, which detects contact with the inner wall of the body cavity (targeting the blood flow component of the inner wall of the body cavity), and a temperature sensor S1 are arranged axially on the flexible shaft so that they face a common specific circumferential direction (Figure 1a). Here, the common specific circumferential direction refers to a specific phase direction around the axis in an axial view as shown in Figure 1d (the direction of the leader line labeled 31 in Figure 1d).

[0042] (Flexible shaft 1) The flexible shaft 1 has a convex, rotating, bullet-shaped shaft head 111 and a built-in detection unit, and the shaft head 11 and the rod-shaped shaft section 12 are integrally connected in the axial direction (Figures 1, 2, 5, 6, etc.). A shaft rod 100A is built into a portion of the central part of the flexible shaft.

[0043] The shaft portion 12 has elastic deformability and flexibility, and a shaft head 11 is provided at the end of the shaft, giving it a rod-like shape with a bulging tip, and the tip of the shaft head 11 is a bullet-shaped shaft head.

[0044] (Attachment structure) In this embodiment, corresponding attachment structures 121 and 122 are provided at the base of the shaft head 11 and the tip of the shaft portion 12, respectively. By bringing the end faces of one attachment structure 121 and the other attachment structure 122 into contact and rotating them in one direction to engage the locking projection 121C of one attachment structure 121 and the locking groove 122D of the other attachment structure 122, the attachment structures come into contact and join together. This joined state can be removed by rotating them relative to each other in a specific direction (Figure 3).

[0045] (Cleaning cover 3) In the embodiment, a cleaning cover 3 is further provided that integrally covers at least a portion of the shaft head 11 at the tip of the flexible shaft, specifically the axial position of the detection range of the sensor group (S1, S2), and / or the cover area beyond that. The cleaning cover 3 is made of an elastically deformable resin molded body such as EVA resin, which is connected to a hemispherical portion 31 that covers the hemispherical portion which is the narrowed part at the tip of the shaft head 11, a cylindrical portion 32 that is attached around the cylindrical portion of the shaft head 11, and an annular end 32E of the cylindrical portion 32. The cylindrical portion 32 has a window portion 3H that is sized to correspond to the sensor installation area, and the surface of the cylindrical portion around the window portion 3H is made of a water-absorbing cleaning material, such as a napped cloth, a cleaning cloth, or a cloth with brushed bristles. The tip may also be made of a water-absorbing cleaning material.

[0046] The inner diameter of the aforementioned "cleansing cover" is made to be the same as or slightly larger than the diameter of the flexible shaft, which makes it easy to remove the "cleansing cover" after rectal insertion.

[0047] The measuring surface of the installation area equipped with each sensor is composed of a single flattened circular (elliptical or oblong) region (either horizontally or vertically elongated). The cleaning cover is made of a napped brush or a cleaning cloth and has a window portion 3H that conforms to the shape of the flat, circular installation area, and the measuring surface of the installation area is exposed within this window portion 3H. The cleaning cover is equipped with a cleaning cloth or cleaning brush at least along the periphery of the window portion 3H, and these brushes or cleaning cloths are used to clean the detection surface inside the body cavity that is opposite to the measurement surface in the installation area within the window portion 3H.

[0048] The window portion 3H of the cleaning cover may be left open, or a portion of it may be covered with a translucent sheet.

[0049] The hemispherical portion 31 and the cylindrical portion 32 constituting the cleaning cover 3 may be configured as a single, connected part, as in Example 1 (Figures 1 and 2) and Example 3 (Figure 4), or as separate parts that can be connected by overlapping the connecting ends of the ring body, as in Example 2 (Figure 3). Alternatively, as in Example 3 (Figure 4), it may be in a form that can be transformed into a compact, short cylindrical bag by turning the end opening inside out and rolling it up.

[0050] (Contact-type sensor group) The shaft head 11 of the flexible shaft is provided with a flat measurement surface 11F, which is formed as a flat or gently curved surface in a specific circumferential direction, and whose periphery is formed as a rounded edge. This flat measurement surface 11F is equipped with a group of sensors consisting of contact-type or non-contact-type sensors that target blood flow information of the inner wall of the body cavity. The group of contact-type sensors consists of multiple types of contact-type optical sensors, temperature sensors that acquire various information of the inner wall of the body cavity, sound wave sensors, radio wave sensors, infrared sensors, electromagnetic wave sensors, electrocardiogram electrodes, and vibration sensors. The non-contact-type sensors consist of either non-contact-type optical sensors or image sensors. The group of sensors used in this invention consists of a combination of any multiple of these multiple types of sensors.

[0051] The contact-type sensor group in this embodiment consists of a temperature sensor S1 having a detection unit made of a circular transparent window, and a reflective pulse oxisensor S2 having a detection unit made of a rectangular transparent window. They are arranged in the axial direction so that they face the same circumferential direction, i.e., a specific lateral direction. In this embodiment, it consists of a combination of a blood flow sensor S2 targeting blood flow components and a temperature sensor S1, but a pressure sensor may also be added. Based on the measured values ​​of each sensor that are considered to be correlated, a comprehensive determination is made as to whether an abnormal measurement state is occurring. Foreign matter is removed from the vicinity of the measurement surface by the measurement surface 11F of the installation area formed of a flat or gently curved surface, and a cleaning cloth that covers its periphery in a border shape, allowing the measurement surface to make stable contact with the inner wall of the body cavity. In addition, by arranging them in the axial direction on the measurement surface 11F, the SpO2 temperature of the contact surface can be accurately measured.

[0052] (Blood flow sensor S2) As the blood flow sensor S2, a reflective or transmissive sensor can be used. This utilizes the difference in light transmittance / reflectance to receive light of multiple wavelengths with a light receiving sensor, and by measuring the light intensity and wavelength of the reflected / transmitted light, the light transmittance of the reflected signals of arterial and venous blood flow in the inner wall of the body cavity in contact with the sensor is compared and measured. In this embodiment, a reflective pulse oxi sensor is used, and the light sensor determines whether it is arterial or venous blood, and an electrocardiogram waveform is acquired by measuring the oxygen saturation of arterial blood.

[0053] (Detection of abnormal measurement conditions) Detecting abnormal measurement conditions (determining whether or not an abnormal condition exists) involves determining whether the adhesion to the rectum is abnormal (whether the light interference from stool, etc., or the magnitude of the adhesion force to the intestinal wall is within the normal measurement range) or whether measurement is abnormal due to unexpected body movement (whether or not measurement is impossible due to body movement).

[0054] The system determines the detected value (whether the pulse peak can be identified (no value can be obtained), whether the peak value is within a predetermined threshold range, and whether it is in a constant rhythm that should be synchronized with the heartbeat (variation in value per unit time due to rapid fluctuations)). Examples include undercounting of the pulse due to poor contact (a state where measurement is impossible due to a low value), abnormal values ​​due to excessive body movement, and discontinuity of measurement values ​​due to changes over time (abnormal values ​​of heart rate due to double counting). For example, a change in unit time (amount of fluctuation) of around 1 second that is more than twice the normal amount is clearly an abnormal amount of change in unit time.

[0055] The temperature sensor S1 measures the temperature of the body tissue in contact with the sensor using a thermometer. The stability of the measurement is determined by whether the thermometer reading is within the normal range and by the rate of change per unit time. For example, abnormal measurement values ​​or clearly abnormal rate of change per unit time of around 1 second can be pre-set, and if these set values ​​are exceeded, it can be determined that the measurement is abnormal.

[0056] (Sudden body movement) Causes of abnormal measurement conditions include unexpected body movements and the presence of foreign objects. Animals may experience unexpected body movements unintended by the measurer due to the need for restraint, differences in posture, or insufficient fixation by the tail. In this state, proper SpO2 measurement cannot be performed. To address this, the present invention forms a flat measuring surface 11F for contact measurement, which is substantially flat in a specific circumferential direction on the shaft head. The processing unit 2 is operated so that this flat measuring surface 11F is pressed against the rectal wall, and the measurement is performed by making the bulging flat measuring surface 11F of the shaft head adhere closely to the intestinal wall (Figure 5). This makes it easier to maintain a normal measurement state even if unexpected body movements occur. Furthermore, by measuring in the rectum, measurement errors due to light interference, pigmentation, and the influence of body hair are eliminated in the first place.

[0057] The processing unit 2 of the present invention includes a step of determining a normal measurement state by analyzing whether the electrocardiogram waveform obtained by a reflective pulse oxisensor (blood flow sensor S2) incorporated in a flexible shaft is repeating regular time fluctuations within a predetermined distortion range. This utilizes the principle that, as long as there is no arrhythmia, the electrocardiogram waveform will be synchronized with the sensor in a normal measurement state without body movement or bowel movement interference.

[0058] (Processing 2) The processing unit is the part that performs calculations on the data obtained by the measurement unit. In this embodiment, the processing unit is built into a thin, rectangular parallelepiped-shaped processing unit body 2, which is integrated with the flexible shaft 1. The calculation process is characterized by eliminating false detections by determining the rectal contact state, that is, determining the presence or absence of an abnormal measurement state based on the detected values ​​of each sensor. In this embodiment, an output unit is further built into the thin, rectangular parallelepiped-shaped processing unit body 2. The processing component body 2 of this embodiment has the processing unit and output unit built inside, and also includes a display unit 21 that displays processing data in liquid crystal on the front, an authentication data acquisition unit 23, and a beaker (not shown) that notifies of abnormal conditions. A switch 25 and two buttons 24 that serve as both a lock button and a setting button are provided on the side of the end. A cover plate 26 with a knob for replacing the built-in battery and memory is incorporated on the back.

[0059] The presence or absence of an abnormal measurement condition is determined, for example, by whether the pulse peak can be identified, whether the peak value is within a predetermined threshold range, whether the rhythm is consistent with the electrocardiogram waveform, and whether the temperature sensor detected value is within the normal range.

[0060] More specifically, it has a continuous measurement function that intermittently or continuously measures the tissue oxygen saturation of microvessels in the rectal tissue over a predetermined period of time, and saves the measured values ​​along with a time code, thereby determining whether the SpO2 sensor detected value falls within a predetermined threshold range of a constant fluctuation pattern, and detecting waveform disturbances caused by body movement or changes in posture.

[0061] (Estimation step based on synchronicity) In determining abnormal measurement conditions, a step to estimate normal measurement conditions can be included, based on the synchronization of SpO2 and temperature changes. Generally, there is a correlation between SpO2 and temperature changes. By determining the correlation between SpO2 and temperature changes, it is possible to determine if the measurement condition is normal. Furthermore, abnormal measurement conditions can be determined based on heart rate changes that do not correlate with body temperature fluctuations. That is, body temperature fluctuations are generally due to inflammation, and heart rate should increase in conjunction with this, but if they do not correlate, there is a possibility of an abnormal measurement condition. On the other hand, if body temperature is normal, but only heart rate (circulatory function) or SpO2 (pulmonary function) is abnormal, it can be determined that there is a high probability that the measurement condition is normal.

[0062] In the processing step by the processing unit, Based on the potential difference between the electrode terminals inside the rectum and each attachment point, an electrocardiogram waveform is acquired, the heart rate is obtained from the RR interval of the electrocardiogram waveform, and the heart rate, which is the output information, is processed.

[0063] Furthermore, in the processing step, The system obtains respiratory rate from changes in electrical resistance between electrode terminals, changes in the RR interval of a continuous electrocardiogram waveform, or respiratory waveforms and peak intervals from sensors attached to the rectum, skin, or mucous membrane. The respiratory waveform, electrocardiogram waveform, or information derived therefrom, such as respiratory rate, heart rate, information readable from the respiratory waveform and electrocardiogram waveform, and information on disease or health status, are then processed as output information.

[0064] The primary biometric information acquired by the biometric information acquisition sensor includes at least one of the following: oxygen saturation, oxygen saturation waveform, tissue oxygen saturation, tissue oxygen saturation waveform, pulse rate, and body temperature.

[0065] If the additional detection unit includes a second biometric information acquisition sensor, the second biometric information acquired by it consists of at least one of the following: oxygen saturation, oxygen saturation waveform, tissue oxygen saturation, tissue oxygen saturation waveform, pulse rate, and body temperature at the mounting location of the additional detection unit, and is of the same type as the first biometric information. By continuously acquiring the same type of biological information as the first biological information at multiple locations using the additional detection unit, it is possible to estimate whether the acquired biological information values ​​are correct or not.

[0066] (Output processing of "blood pressure related information") In the processing step, the processing unit calculates the "change in pulse wave propagation velocity or pulse wave propagation time" based on at least one of the first biological information and the second biological information, and the electrocardiogram information, and obtains an estimated blood pressure value or blood pressure change information, i.e., "blood pressure related information," as output information.

[0067] The output processing of the aforementioned "blood pressure-related information" may also involve acquiring oxygen saturation waveforms or tissue oxygen saturation waveforms at two or more different sensor placement locations, and calculating the "change in pulse wave propagation velocity or pulse wave propagation time" by comparing each waveform and the electrocardiogram waveform. That is, when multiple locations on which biological information acquisition sensors are placed among multiple attachment points or the rectum of the target animal are designated as sensor placement locations, Each sensor placement unit acquires either an "oxygen saturation waveform or a tissue oxygen saturation waveform, i.e., a saturation waveform," Based on the waveform shape of the oxygen saturation waveform or tissue oxygen saturation waveform acquired at each sensor placement unit, the waveform shape of the electrocardiogram waveform in the electrocardiogram information, the time difference information obtained from each waveform of the oxygen saturation waveform or tissue oxygen saturation waveform, or their fluctuations, The system retrieves "blood pressure-related information," which is either an estimated blood pressure value or information regarding blood pressure fluctuations, as output information.

[0068] (Output processing of "arterial-related information") Furthermore, by acquiring "oxygen saturation waveform or tissue oxygen saturation waveform" as the first and second biological information at two or more different sensor placement locations, acquiring an electrocardiogram waveform as electrocardiogram information, and comparing these with each sensor placement location, it is possible to process "arterial-related information," which is one or more pieces of information such as the degree of hardening or flexibility of the arteries from the heart to each sensor placement location, stenosis or occlusion, or bleeding, as output information.

[0069] In other words, in the processing step, the processing unit, based on the waveform shapes of the oxygen saturation waveforms or tissue oxygen saturation waveforms acquired at two or more different sensor placement locations, the waveform shape of the electrocardiogram waveform in the electrocardiogram information, time difference information obtained from each waveform of the oxygen saturation waveform or tissue oxygen saturation waveform, or their fluctuations, The "change in pulse wave propagation velocity or pulse wave propagation time" is calculated and processed. The system processes "arterial-related information," which includes one or more pieces of information such as the degree of hardening or flexibility of the arteries, information on stenosis or occlusion, or information on arterial bleeding, from the heart to each sensor placement location that acquires biological information, as output information.

[0070] When processing primary biological information obtained in the rectum and secondary biological information obtained at multiple attachment sites, if the same type of biological information values ​​obtained at multiple sites differ significantly, the measurement accuracy or the normality of the measurement state is obtained as output information by comparing the fluctuations in oxygen saturation based on other biological information values ​​with the fluctuations in the electrocardiogram waveform obtained by the electrocardiogram electrodes.

[0071] Furthermore, when respiratory waveform information is obtained based on resistance value information from the high-frequency current from the electrode terminals of the additional detection unit, respiratory rate information is acquired as output information by utilizing the variable length of the continuous inter-heartbeat time in the respiratory waveform information.

[0072] (Example 1) The biological information acquisition device of Embodiment 1 of the present invention, shown in Figures 1-2, comprises a measurement unit 1 consisting of a rod-shaped flexible shaft (shaft base 11, flexible shaft portion 12, shaft head 13) that is inserted into the body cavity of a target animal, contacts the wall of the body cavity at the insertion site, and has a group of sensors near its tip, It consists of a box-shaped housing integrated with the flexible shaft 1, and a processing unit 2 that performs calculations on the data obtained by measurement, The display unit 21, which is an output unit that outputs the output data after calculation processing as a signal, is provided on one side of the box-shaped housing of the processing unit 2. A transmitter 27 is provided near the base of the box-shaped housing of the processing unit 2, and outputs the output data after calculation processing as a signal by transmission, The device is configured to include a "cleaning cover 3" which is a cover body that covers the area around the shaft head of the flexible shaft of the measuring unit 1, excluding the specific installation area.

[0073] The biometric information acquisition and display system of Embodiment 1 of the present invention, shown in Figure 1, comprises: a biometric information acquisition device; a portable terminal device 28 equipped with an output unit 281 that receives and displays data transmitted from the transmitter 27 of the biometric information acquisition device; a data server 4 that receives and stores data by existing communication means; a processing terminal device 51 that sends and receives data with the data server 4, displays it on a display unit 51, inputs supplementary information of the data on an input unit 52 to process it into management data, and stores the management data together with the data server 4; and a portable terminal device 61 equipped with an output unit that receives and displays data from the data server 4.

[0074] The measuring unit (1) of Example 1 is A rod-shaped flexible shaft in which a shaft base 13, a flexible shaft portion 12, and a shaft head 11 with a cylindrical cross-section are sequentially connected in the linear axis direction, It consists of sensor groups S1 and S2, which are built into the shaft head 11 of the flexible shaft and whose detection units are clustered together within a specific installation area in a specific circumferential or tip direction of the shaft head 11.

[0075] The shaft base 11 of the flexible shaft is fixed to the front end surface of the box-shaped housing of the processing unit 2 and consists of a constricted frustoconical shape that protrudes laterally. A small hole-shaped sensor terminal hole 13C is provided on the top surface of the frustoconical, allowing the sensor terminal rod 12C to be inserted and connected into the hole (Figure 2).

[0076] The middle section of the flexible shaft consists of a cylindrical flexible shaft section 12. This cylindrical flexible shaft section is made of an elastic rod whose axis, i.e., the axis of the extending cylindrical shaft, is elastically bendable. Inside the elastic rod, a communication wire is built along the axial direction, i.e., the extension direction, for transmitting detection information from the shaft head at the tip. The base end of the flexible shaft section 12 consists of a short connecting section that is conically widened, and a sensor terminal rod 12C, made of a thin rectangular rod, protrudes from the center of the end of the connecting section. The sensor terminal rod 12C is inserted into the sensor terminal hole 13C of the shaft base 11, thereby connecting to the communication wire inside the flexible shaft section 12 in a signal-transmitting manner, and transmitting detection information from the sensor group to the sensor terminal hole 13C.

[0077] The tip of the flexible shaft consists of a shaft head 11 that is shaped like a capsule and has a larger diameter than the flexible shaft portion 12. The shaft head 11 is integrally composed of a conical, enlarged diameter portion that is larger in diameter than the flexible shaft portion at the tip of the flexible shaft portion 12, a cylindrical portion with a larger diameter than the flexible shaft portion, and a hemispherical, rounded tip of a cylinder. A measuring surface is formed on the side of the cylindrical portion of the shaft head 11 in a specific axial direction, forming an elliptical installation area that is elongated in the direction of the cylindrical axis of the cylinder. Within this measuring surface of the installation area, the detection section of a sensor group consisting of multiple sensors (S1, S2) is arranged in a row.

[0078] The sensor group consists of multiple types of sensors that contact the wall of the body cavity to which it is inserted (internal wall, e.g., rectal wall) to detect multiple types of detection values. The sensor group in Example 1 consists of a temperature sensor S1 and an optical sensor S2. The circular detection part of the temperature sensor S1 and the rectangular detection part of the optical sensor S2 are positioned in close proximity to each other on the axis of the flexible shaft within an elliptical installation area.

[0079] (Processing 2) The processing unit 2 of Embodiment 1 is the part that performs calculations on the data obtained by the measurement unit. The processing unit of Embodiment 1 is housed in a thin, rectangular box-shaped enclosure, and this box-shaped enclosure 2 is equipped with a display unit that shows detection information and abnormality / condition detection status, and a display button.

[0080] The cleaning cover (3) consists of a strip-shaped or cap-shaped cover body (cap-shaped part 31, strip-shaped part 32) that covers the cover area at the tip of the shaft head, including the axial range of the installation area of ​​the flexible shaft part 12 and excluding the installation areas of the optical sensor S2 and the temperature sensor S1. The cover body of the cleaning cover 3 in the embodiment is integrally composed of a hemispherical cap-shaped part 31 that bulges outwards in a spherical projection towards the tip, and a cylindrical strip-shaped part 32 connected to the base of the cap-shaped part 31. The entire surface of the strip-shaped part 32 is made of a cleaning cloth, and the cleaning cloth is napped to have a cleaning function and a water absorption function.

[0081] (Measurement part) The cleaning cover of Embodiment 2 shown in Figure 3 consists of a cap-shaped cover body with a semi-ellipsoidal tip and a cylindrical side cover body. The ends 32F of each cover body are overlapped and attached to the shaft head for use. The side cover body has a strip-shaped piece of formal cloth on its surface that contacts and cleans the wall of the body cavity to which it is inserted, around the shaft head, excluding the specific installation area of ​​the flexible shaft. The tip cover is made of an elastic resin, and the cylindrical side cover is made of a stretchable cleaning cloth. The tip of the cap-shaped tip cover is designed to be thicker than 150% but not exceeding 200% of the side thickness 32F.

[0082] The measurement unit (1) of Example 2 shown in Figure 3 is the same as in Example 1. A rod-shaped flexible shaft in which a shaft base 13, a flexible shaft portion 12, and a shaft head 11 with a cylindrical cross-section are sequentially connected in the linear axis direction, It consists of sensor groups S1 and S2, which are built into the shaft head 11 of the flexible shaft and whose detection units are clustered within a specific installation area in a specific circumferential or tip direction of the shaft head 11. However, in the measurement unit of Embodiment 2, the measurement surface of the installation area of ​​the shaft head 11 has an oval shape that allows for the placement of detection units of two or more sensors, and two detection units of sensors are arranged within the measurement surface of this installation area.

[0083] A group of sensors (a combination of multiple optical sensors, temperature sensors, sound wave sensors, radio wave sensors, infrared sensors, electromagnetic wave sensors, electrocardiogram electrodes, vibration sensors, and image sensors) are arranged in close proximity to each other in a specific circumferential direction of the flexible shaft or in a specific installation area on the shaft head at the tip, and are used to detect values ​​by contacting the wall of the body cavity to which it is inserted (internal wall, e.g., rectal wall).

[0084] The "cleaning cover" of Embodiment 3 shown in Figure 4 can be transformed into a compact, short cylindrical bag by turning the end opening of the long, bag-shaped resin bag inside out and winding it around the outer surface of the bag tube, as shown in Figures 4(a), (c), and (d). Furthermore, the shaft head, which is the measuring part of Embodiment 3, is integrated with a flexible shaft, and the shaft head consists of a rod-shaped flexible shaft that does not have a bulge. In other words, the shaft head of Embodiment 3 consists of a cylindrical rod with an outer diameter corresponding to the inner diameter of the bag-shaped cleaning cover, and its tip is hemispherical.

[0085] The cleaning cover of Example 3 consists of a long, bag-shaped periphery made of an elastic material having a window portion 3H on its side. Here, "long, bag-shaped" refers to a shape in which the tip narrows to form the bottom of the bag, and the opening end 33, which is the base of a cylindrical body, is formed as the opening of the bag. The opening of the bag has an annular ring-shaped opening end 33 that bulges outward from the outer diameter of the cylindrical body, and the length of the bag tube portion 32 can be adjusted by winding this opening end 33 towards the cylindrical body and folding it back in sequence. Furthermore, it can be transformed into a short cylindrical bag shape with the portion in contact with the body cavity wall rolled inward and stored, making it removable. By winding the surface of the bag tube in this way to create a short bag shape and removing it, the cleaning cover can be replaced without causing any hygiene problems.

[0086] Furthermore, the tip portion 31, which is the bottom of the cleaning cover in Example 3, is made of a variable-thickness resin material that gradually becomes thicker than the circumferential portion. This allows the tip to elastically deform when inserted into a body cavity such as the vagina or intestine, and the slightly thicker resin tip portion 31 enables smooth insertion. In addition, the opening of the cleaning cover in Example 3 is formed with a circular cross-section, and its inner diameter is made larger than the diameter of the flexible shaft, making it easy to remove the "cleaning cover" after insertion into the rectum.

[0087] The shaft head at the tip of the shaft has a light-emitting unit that illuminates the surrounding area by emitting light outside the shaft, an imaging camera, Alternatively, the device may be characterized by having a group of sensors (a combination of multiple of the following: optical sensors, temperature sensors, sound wave sensors, radio wave sensors, infrared sensors, electromagnetic wave sensors, electrocardiogram electrodes, and image sensors).

[0088] In Embodiment 4 shown in Figure 5, the tip of the shaft head 11, which is the tip of the measuring section, is made of a transparent or translucent hemispherical cover, and a light-emitting unit with an imaging camera is built into the cover at the tip of the shaft, facing axially towards the front. Embodiment 4 shown in Figure 5 is a configuration in which the light-emitting unit with an imaging camera is installed facing the shaft tip, i.e., towards the front, and the cleaning cover is made of a translucent, bag-shaped elastic resin that covers the entire shaft head 11.

[0089] Similar to Example 3, the cleaning cover is installed in an expanded state, extending from a shortened state with the end opening 33 wound up to cover the entire axial direction of the shaft head. When installed in the expanded state, the cleaning cover has an oval-shaped window in a specific lateral direction, and the detection part of the sensor group is exposed within this window 3H. Also, as shown in Figure 5(a2), when the cleaning cover is installed, the light-emitting irradiation part of Example 4 is made to emit light, illuminating the surroundings with a faint light source, i.e., towards the tip, and allowing the imaging camera to capture images of foreign objects on the inner wall that do not easily transmit light.

[0090] The measurement section (1) of Embodiment 4 is similar to Embodiment 1, and consists of a rod-shaped flexible shaft in which a shaft base 13, a flexible shaft section 12, and a cylindrical shaft head 11 are sequentially connected in the linear axis direction. It consists of sensor groups S1 and S2, which are built into the shaft head 11 of the flexible shaft and whose detection units are clustered together within a specific installation area in a specific circumferential or tip direction of the shaft head 11.

[0091] In Embodiment 5 shown in Figure 6, the tip of the shaft head 11, which is the tip of the measuring unit, is made of a transparent or translucent hemispherical cover, and a light-emitting unit with an imaging camera is built into the cover at the tip of this shaft, facing laterally with respect to the axial direction. The light-emitting unit with an imaging camera in Embodiment 5 is installed facing a specific lateral direction in which the sensor's detection units are arranged, and the cleaning cover is made of an elastic resin bag-like cylinder that covers the entire shaft head 11, and its entire perimeter is covered with a brushed cleaning cloth.

[0092] Furthermore, the cylindrical body has an oval-shaped window portion 3H on its side, and a tip window portion 31A, which is a roughly trapezoidal opening, located near the front of the window portion 3H and corresponding to the light-emitting irradiation portion. The opening end portion 33E is made of an elastic ring corresponding to the diameter of the flexible shaft portion 12, and maintains its attached state by elastically adhering to the conical base of the shaft head portion 11 when the cleaning cover is attached. Also, by emitting light from the light-emitting irradiation portion of Embodiment 5, the surrounding area is illuminated from the opening of the tip window portion, and the irradiation portion is captured by the imaging camera and displayed on the display unit in real time, or the captured image is recorded. The cleaning portion is irradiated toward the light source, i.e., the irradiation direction of the side, and foreign matter that does not easily transmit light from the inner wall of the airborne unit is captured by the imaging camera.

[0093] In the embodiment 6 shown in Figure 7, a cleaning liquid injection nozzle 15 is provided at the front of the installation area equipped with a sensor group and detection units for the optical sensor S2 and the temperature sensor S1. This injection nozzle 15 is equipped with a cleaning liquid delivery device (25S, WH, WT) that communicates with it through an internal liquid tube. Specifically, the injection nozzle 15 consists of a liquid tube 153 housed along the axis of the shaft head of the measuring unit 1, an orifice section 152 that bends and accelerates the delivery direction at the tip of the liquid tube 153, a spherical shut-off valve 152B housed in the orifice section 152, and a nozzle outlet 151.

[0094] Furthermore, a liquid pipe 153, which is connected through the flexible shaft, is connected to a discharge volume adjustment device (not shown) housed inside the processing unit 2 of the housing, and a discharge tank WT equipped with a discharge pump is externally connected via an external liquid pipe WH connected from the discharge volume adjustment device (Figures 7 and 8). In Embodiment 7, the discharge switch 25S of the discharge pump is provided in the processing unit 2 of the box-shaped housing. As the cleaning liquid is discharged, the optical sensor and the temperature sensor each detect measurement values, and the presence or absence of an abnormal measurement state is determined based on the detected values. This determination result, along with the detected values ​​of each sensor, is output as calculation data to the output unit as a signal.

[0095] Furthermore, the tip of the measuring section 1 in Example 6, like in Example 3, is made of a rod-shaped body that is integrally formed with the same diameter as the flexible shaft and does not have a bulge. The installation area of ​​the shaft head is an oval-shaped curved surface that demarcates a part of the measurement direction, which is a specific radial direction of the cylindrical rod, and rectangular detection sections of sensors S1 and S2 are provided side by side in the central part of this surface. A rectangular nozzle section is exposed on the tip side of this installation area (Figures 8 and 9). A long, bag-shaped cleaning cover 3 made of elastic resin corresponding to the shape of the shaft head is attached to cover the shaft head. The open end can be turned inside out by winding, and by folding this open end back and unfolding it, it becomes a long, bag-shaped unfolded state. In addition, two openings consisting of a tip window and a window section are provided on the side of the cleaning cover in a specific direction, at positions corresponding to the injection nozzle 15 of the shaft head and the detection section of the sensor in the installation area.

[0096] The processing unit determines whether or not an abnormal measurement state is present based on the detected values ​​of the optical sensor and the temperature sensor, and outputs this determination result, along with the detected values ​​of each sensor, as calculation data to the output unit.

[0097] The system further comprises a notification unit connected to the flexible shaft by wire or wireless means, The notification unit receives the calculation data signaled out by the output unit via a wired or wireless connection, displays the sensor detection value, and notifies the result of the abnormal measurement state using sound, light, or display notification means.

[0098] It has a continuous-intermittent measurement function that intermittently or continuously measures information on blood flow in the tissues within the body cavity wall (oxygen saturation or tissue oxygen saturation) over a predetermined period of time, and by saving the measured values ​​along with a time code, it is possible to determine whether the detected value of the optical sensor falls within a predetermined threshold range of a constant fluctuation pattern, thereby detecting waveform disturbances caused by body movement or changes in posture.

[0099] The device is characterized by having a tip-emitting irradiation unit, along with a reflective pulse oxisensor and a temperature sensor arranged axially on the measurement surface of an installation area formed in a specific circumferential direction of the flexible shaft, which is either planar or gently curved, and which targets the blood flow component of the inner wall of the body cavity. The measurement surface of the installation area in Example 1 is elliptical in shape, capable of accommodating the detection units of two sensors, while the measurement surface of the installation area in Examples 2, 3, and 4 is oval in shape, capable of accommodating the detection units of two or more sensors.

[0100] The device is characterized by a tip bulge consisting of a convex rotating body or elongated spherical shaft head and a built-in contact-type sensor group consisting of an optical sensor and a temperature sensor, and a rod-shaped shaft portion, which are joined together by an attachment structure or are detachably combined.

[0101] For example, it allows for the comparison of electrocardiogram measurements taken at various positions on the body, including the lower body, with the heart in between. By using internal (intestinal) data as the primary source of electrical potential information, it is possible to obtain waveforms with less noise, enabling highly accurate measurements.

[0102] Although only one type of electrocardiogram (two-lead / three-lead only) can be obtained, it can measure accurately (without noise) in a simple manner. Because it crosses the body vertically, it is thought to have less physical resistance. Since the influence of individual differences in attachment locations is small, statistical comparisons can be made.

[0103] The biological information acquisition sensor (1) of Embodiment 3 shown in Figure 4 is attached to a measurement unit consisting of a rod-shaped flexible shaft that is inserted into the rectum of the target animal for measurement. The measurement unit is equipped with a blood flow sensor and a temperature sensor that contact the inner wall of the body cavity and are arranged side by side in the same specific circumferential direction of the flexible shaft.

[0104] (processing) The processing unit determines whether or not an abnormal measurement state is present based on the detected values ​​of each sensor, and outputs this determination result, along with the sensor detected values, as calculation data to the output unit as a signal. One design feature for acquiring electrocardiogram information from within the intestines, rather than from the body surface (which is affected by skin resistance due to hardening), is a sensor shaft head made of a metal cover 11 integrated with a conductive material. Because it is in wet contact with the organ, the electrical resistance is low, noise is less likely to occur, and highly accurate measurements are possible.

[0105] (Contact-type sensor group) On the side of the flexible shaft, a group of contact-type sensors are arranged axially so that they face the same circumferential direction, i.e., a specific lateral direction. In this embodiment, it consists of a combination of a blood flow sensor S2 and a temperature sensor 110S, but a pressure sensor may also be added. Based on the measured values ​​of each sensor that are considered to be correlated, a comprehensive determination is made as to whether an abnormal measurement state is occurring.

[0106] [3] (Blood pressure related information) The first biological information mentioned above is intestinal potential information and oxygen saturation waveform information. The biological information described in the second and third sections above consists of potential information and oxygen saturation waveform information at the terminal attachment site. The processing unit calculates and processes blood pressure-related information, including changes in pulse wave propagation velocity, based on electrocardiogram waveform information and oxygen saturation waveform information. The output unit is characterized by displaying the blood pressure-related information on the display unit.

[0107] The above is a biological information acquisition device that processes changes in pulse wave propagation velocity as blood pressure-related information and outputs it.

[0108] Because electrocardiogram potential information is acquired from "inside the intestines" rather than from the body surface (which is affected by skin resistance due to hardening), the electrical resistance is low due to the wet contact with the organ, resulting in less noise and enabling highly accurate measurements.

[0109] <Effects of the Examples> This invention provides a biological information acquisition device or method that can avoid misinterpretation of data due to abnormal measurement conditions by incorporating notification means for alerting about the measurement status of a specific individual. Specifically, the following effects can be considered advantages. While measuring oxygen saturation is difficult in cases of low blood pressure or when arterial pulsation is weak (or absent), tissue oxygen saturation can be measured. Tissue oxygen saturation is a measurement that includes venule and capillary components, making it possible to measure even minute bleeding within tissues, which is difficult to reflect with oxygen saturation alone. • Its shape allows for the detection of rectal pressure and is easy to place in the rectum (the values ​​are stable and less likely to be resisted by the animal being measured, making it suitable for examinations of active animals). In particular, the relatively thin elastic shaft has a flattened, balloon-shaped head, making it suitable for monitoring the depth of anesthesia. It can also detect the occurrence of extra pain and predict potential movement-related accidents.

[0110] <Use in rectal and anal manometry> The biological information acquisition device of the present invention can be used to detect the state of experiencing pain, or to evaluate rectal and anal manometry performed for the diagnosis of fecal incontinence.

[0111] (Inpatient / Visit Information) The processing method of the measurement system equipped with the acquisition device of the present invention further comprises the step of setting hospitalization information or hospital or facility visit information for predetermined symptoms of the target individual, and can output data separately for hospitalization / visit and data at home.

[0112] (Group record of pre- and post-operative data) The system further comprises the steps of saving treatment information for a specific symptom of the target individual, and grouping and recording resting data of the target individual during the pre- or post-operative period as attribute data for the symptom. For example, by combining attribute groups such as "medical history," "surgical history," "pre- and post-operative," and "pre- and post-contraception," it is possible to assess the post-operative progress.

[0113] (Alert output) The system determines whether the transmitted data exceeds pre-set upper limits, lower limits, and average values, and outputs an alert if it detects that the values ​​have been exceeded.

[0114] In this system, it is preferable to perform individual device identification based on personal data (PD) when acquiring data or when storing data on the server.

[0115] Furthermore, it is preferable to have a matching unit that performs comparison with differences in data storage or measurement, and with individual identification using the microchip number. For example, the processing unit 2 may include a reading unit 23 that acquires and authenticates microchip data of a living animal and a matching unit that compares the read data, and during data storage or output processing by the output processing unit in the server 4, it may be possible to link it with personal data PD and treatment data MD, and to intervene in a matching step of individual identification information of the living organism, such as the microchip number.

[0116] (Communication log between pet owner and veterinarian after the alert) When acquiring measurement data, the system can output the measurement results or discrimination results to the owner terminal 61, the attending physician, or the hospital terminal 5. In addition, when normal data is identified and an emergency status notification is issued due to data abnormality, the system can secure a text chat or voice communication line, display that the line is available, and record the communication after the line has been used.

[0117] Estimation of rectal temperature: A system can be implemented that processes data using a wearable transmitter worn continuously and an intestinal insertion examination device (biometric information acquisition device). The system can also be configured to output data from an intestinal insertion examination device (biometric information acquisition device) temporarily inserted into the intestines of the target organism to a wearable transmitter that is continuously worn by the organism, and to have an output unit that transmits data via the wearable transmitter.

[0118] The aforementioned biological information acquisition device can measure at least pulse rate and rectal temperature, and can calculate the estimated rectal temperature or display the error in pulse rate. For example, the rectal temperature is estimated by assuming that the time corresponding to the highest and lowest rectal temperature coincides with the time corresponding to the highest and lowest epidermal temperature.

[0119] If oxygen saturation could be measured rectally, similar to body temperature measurement, it would reduce the effort involved while simultaneously ensuring the stability and reproducibility of the measurement results.

[0120] According to embodiments of the present invention, an estimation device and a method for estimating blood flow information are provided, which enable the evaluation of the measured value itself as an absolute value, or the determination of whether the measured value is normal or abnormal, and which also ensure the reproducibility of the measured value, as the measured value is less likely to fluctuate depending on the measurement conditions, the subject of measurement, or the person performing the measurement.

[0121] (Measurement principle) One form of biometric information acquisition sensor is a light-emitting blood flow sensor. There are two types of light-emitting blood flow sensors: a transmissive type that measures oxygen saturation by sandwiching the target blood vessel between a light-emitting sensor and a receiving sensor, and a reflective type that does not sandwich the target blood vessel. In this invention, a reflective type biometric information acquisition device is provided, with a temperature sensor placed nearby. By making the shaft shape tapered at the end and placing the sensor in this tapered portion, more reliable measurements can be achieved.

[0122] Specifically, the components of the flexible shaft 1 that makes up the inserter may consist of a material in which a cleaning cover 3 made of an elastic resin such as EVA resin is overcoated or non-removable around an elastically deformable shaft rod 100A. Alternatively, the flexible shaft 1 may consist of a core shaft 100A made of metal (a rod with a shape memory alloy or a spring material interposed between the shafts), with the outer sheath material of the adherend attached around the core shaft. The base or head of the shaft portion of the flexible shaft 1, or the boundary portion with the shaft head 11, or a part of the axial direction of the adherend or core material may be provided with a free rotation mechanism that can automatically eliminate twisting, or a core material axial rotation operation mechanism that rotates only the core material in the axial direction.

[0123] (Highly accurate measurement by using the rectum as one of the electrocardiogram electrodes) By using the insertion site within the body as a reference measurement point and "comparing" the propagation speed with one or more other measurement points, the degree of pulse pressure can be determined, enabling blood pressure estimation and acquisition of electrocardiogram information. (Biometric information acquisition sensor (1)) The bio-information acquisition sensor (1) can be any implantable sensor capable of acquiring at least pulse wave information. In this embodiment, a sensor capable of acquiring blood pressure information and SpO2 information is used, which is an optical sensor 110S.

[0124] (Additional detection unit (26c)) The additional detection unit (26c) is a terminal having electrodes and / or an optical sensor that are attached to a mounting location on the surface of the body to acquire conductive information, and is wired to 2G. In another embodiment, by also receiving a sensor in the additional detection unit 26, blood pressure-related information (such as vascular blockage) based on SpO2 can be obtained by comparing SpO2 information at multiple measurement points.

[0125] A wired connection is required to view electrocardiogram information. In this embodiment, the wired connection of the additional detection unit is configured by attaching the cord 26 to the connector 2G using the connector 26G.

[0126] The present invention is not limited to the above embodiments, and various modifications, combinations with known elements, and substitutions of some elements are possible without departing from the spirit of the invention, such as integrating or separating the configuration or increasing or decreasing the number of elements. For example, the processing unit body or the processing unit and display device within it may be configured separately, or processing by the processing unit, output by the output unit, and notification by the notification unit may be performed simultaneously within the management device and output in real time to pre-set relevant terminals. Furthermore, information acquired from different living animals may be accumulated and processed as statistical data for each type of living animal.

[0127] The biological information acquisition device of the present invention is The device consists of a measuring unit comprising a rod-shaped flexible shaft inserted into the body cavity of the target animal, such as the rectum or vagina, for measurement; a processing unit that performs calculations on the data obtained from the measurement; and an output unit that outputs the calculation data from the processing unit as a signal. The device has the following features.

[0128] The measuring unit is equipped with an optical sensor and a temperature sensor, which contact the inner wall of a body cavity to detect a value, arranged in close proximity to each other in an installation area in a specific circumferential direction of the flexible shaft. The flexible shaft is provided with a strip-shaped or cap-shaped cleaning cover (3) on the shaft head, excluding the aforementioned specific circumferential direction, which contacts and cleans the inner wall of the body cavity.

[0129] Each of the installation areas equipped with sensors 9 consists of a single flattened circular installation area (either horizontally or vertically elongated). The cleaning cover (3) is made of a napped brush or a cleaning cloth and has a window portion 3H that conforms to the shape of the flat circular installation area. Clean the area around window section 3H with a brush or cleaning cloth, Points where the optical sensor and temperature sensor are arranged side by side in the axial direction within the window section 3H.

[0130] The cleaning cover (3) consists of a cap-shaped or band-shaped circumferential attachment that is detachably mounted around the tip of the flexible shaft in the entire circumferential direction within a predetermined axial range, and multiple cleaning covers can be replaced.

[0131] The device includes a light-emitting unit that emits light around the outside of the shaft, and an imaging camera. The tip of the shaft is made of a transparent or translucent cover, and the light-emitting unit is built inside this cover at the tip of the shaft. Along with the light emission and imaging by the camera, the optical sensor and temperature sensor detect measured values ​​and output them to the output unit.

[0132] The shaft tip is made of a transparent or translucent cover, and the light-emitting element is built inside this cover at the tip of the shaft.

[0133] The installation area equipped with each sensor and the installation area of ​​the optical sensor S2 and temperature sensor S1 are further forward, and a cleaning fluid injection nozzle and a cleaning fluid delivery device connected through an internal liquid pipe are provided. As the cleaning fluid is delivered, the optical sensor and temperature sensor each detect measurement values, and the presence or absence of an abnormal measurement state is determined based on the detected values. This determination result, along with the detected values ​​of each sensor, is output as calculation data to the output unit as a signal. [Explanation of symbols]

[0134] Measuring part 1 Processing Unit 2 Output section 21 Shaft head 11 Optical sensor S2 Temperature sensor S1 Cleaning cover 3 Flexible shaft section 12 Window section 3H Light-emitting irradiation section Injection nozzle 15 Dispensing device (dispensing tank) WT

Claims

1. A biological information acquisition device comprising a measuring unit consisting of a rod-shaped flexible shaft inserted into the body cavity of a target animal for measurement, a processing unit that performs calculations on the data obtained by the measurement, and an output unit that outputs the calculation data from the processing unit as a signal, The measuring unit is equipped with a group of sensors consisting of multiple types of sensors in close proximity to a specific circumferential direction of the flexible shaft or a specific installation area on the shaft head at the tip, which contacts the wall of the body cavity to be inserted and detects the detected value. A biological information acquisition device characterized by having a cleaning cover that contacts and cleans the wall of the body cavity to which the flexible shaft is inserted, around the shaft head, excluding the aforementioned specific installation area.

2. The installation area equipped with each sensor consists of a single flattened circular installation area (either horizontally or vertically elongated). The cleaning cover is composed of a napped brush or a cleaning cloth and has a window portion 3H shaped to conform to the flat, circular installation area. Clean the area around the window with a brush or cleaning cloth, The biological information acquisition device according to claim 1, characterized in that a plurality of sensors are arranged in an axial direction along a flat, circular installation area within a window, and detect the body cavity wall surface in contact with or without contact.

3. The biological information acquisition device according to claim 1, wherein the cleaning cover consists of a cap-shaped or band-shaped circumferential attachment that is mounted around the entire circumference of a predetermined axial range at the tip of the flexible shaft, and the cleaning cover can be removed by deforming the circumferential mounting shape of the circumferential attachment.

4. The biological information acquisition device according to claim 1, characterized in that the shaft head at the tip of the flexible shaft has a light-emitting irradiation unit that emits light and irradiates the surroundings, and an imaging camera, and the flexible shaft has a sensor group in the specific installation area of ​​the flexible shaft that combines one of each of several types, including an optical sensor, a temperature sensor, a sound wave sensor, a radio wave sensor, an infrared sensor, an electromagnetic wave sensor, an electrocardiogram electrode, and an image sensor.

5. The biological information acquisition device according to claim 4, wherein the shaft head at the tip of the shaft is made of a transparent or translucent cover, and the light-emitting irradiation unit is built inside the cover at the tip of the shaft.

6. A cleaning fluid injection nozzle is built into the tip surface or side surface of the installation area of ​​the flexible shaft, A liquid pipe is internally routed along the axial direction of the rod within the flexible shaft, It comprises a device for delivering cleaning fluid, which is connected through a liquid pipe, The biological information acquisition device according to claim 1, characterized in that, while or after the injection of cleaning solution by an injection nozzle, the body cavity wall is wiped by a cleaning cover on the front side of the installation area, each sensor in the sensor group acquires a measurement value, the presence or absence of an abnormal measurement state is determined based on the measurement value, and this determination result, together with the measurement value of each sensor, is output as calculation data to the output unit as a signal.

7. The system further comprises a notification unit connected to the flexible shaft by wire or wireless means, The biological information acquisition device according to claim 1, characterized in that the notification unit receives the calculation data signal output by the output unit via a wired or wireless connection, displays the sensor detection value, and notifies the determination result of the abnormal measurement state by notification means of sound, light, or display.

8. The biological information acquisition device according to claim 1, comprising an optical sensor having a continuous measurement function that intermittently or continuously measures information on blood flow in tissues within the body cavity wall over a predetermined period of time, wherein the continuous measurement values ​​of blood flow information are stored together with a time code by the optical sensor, and the device determines whether the continuous measurement values ​​fall within a predetermined threshold range of a constant fluctuation pattern, thereby determining waveform disturbances due to body movement or changes in posture.

9. The biological information acquisition device according to claim 1, characterized in that, together with a light-emitting irradiation unit, a reflective pulse oxisensor and a temperature sensor are arranged in the axial direction on a measuring surface formed as a flat or gently curved surface in a specific circumferential direction of the flexible shaft, targeting the blood flow component of the inner wall of the body cavity.

10. The biological information acquisition device according to claim 1, characterized in that a tip bulge portion, which consists of a convex rotating body or elongated spherical shaft head and incorporates a group of contact-type sensors consisting of an optical sensor and a temperature sensor, and a rod-shaped shaft portion are joined together by an attachment structure or are detachably combined.

Images