Biological information acquisition device

Abstract

Provided is a biological information acquisition device or a biological information acquisition method for electrocardiogram information and blood flow-related information that can ensure the reproducibility of measurement values without degrading the accuracy of intestinal measurement regardless of the convenience or foreign matter at the measurement site. 【Solution means】A biological information acquisition device including a measurement unit, a processing unit that performs arithmetic processing on data obtained by measurement, and an output unit that outputs a signal of arithmetic data by the processing unit, wherein the measurement unit includes an optical sensor and a temperature sensor that are arranged in close proximity to each other in an installation area in a specific circumferential direction of a flexible shaft and detect detection values in contact with the inner wall of a body cavity, and a strip-shaped or hat-shaped wiping cover that contacts the inner wall of the body cavity and wipes is provided at a shaft head of the flexible shaft excluding the specific circumferential direction.

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 time changes), and blood pressure), as well as 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 systemic perfusion insufficiency in a patient, those including a surface perfusion pressure monitor and a blood pressure monitor are disclosed (Patent Document 1, Japanese Patent Publication No. 2007-525253). This surface perfusion pressure monitor may include a Doppler sensor or a photoelectric plethysmogram. 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 systemic 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 gastrointestinal tract or upper airway / upper digestive tract of the patient to measure sublingual gland PCO2 and SaO2. It is said that a pH sensor can be used in combination with blood flow determination.

[0003] In the above system, it is described that the measurement of the surface perfusion pressure becomes more accurate by using the reference measurement of blood pressure. Blood pressure can be measured at the upper arm position, toe, and thigh, or it can also be measured directly through an arterial line inserted into an available artery. The measurement of the surface perfusion pressure is divided by the blood pressure measurement to calculate the resulting index, which is referred to as the SPP index (0045).

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

[0005] Separately from the above, a rectal digital thermometer is disclosed. This measures the temperature of the rectal wall in contact with the thermometer inserted into the rectum as the body temperature of a living organism. Considering that the inside of the anus is less affected by the outside air and is supposed to measure the temperature closest to the body temperature, it is used for the examination of a corpse and the diagnosis of patients in a severe body temperature abnormal state.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Patent Document 2

Disclosure of the Invention

Problems to be Solved by the Invention

[0007] Here, it is also conceivable to mount an optical sensor on a rectal digital thermometer and acquire the temperature and blood flow information of the rectal wall by a temperature sensor or an optical sensor brought into contact with the rectal wall surface.

[0008] However, there are many cases where dirt such as feces adheres to or remains in the rectum, and there is a problem that the optical sensor does not function well depending on the state of the rectum. If the location of dirt is included in the detection target by the optical sensor, since the optical characteristics are significantly different from those of the rectum, for example, the reflected wave of ultrasonic waves may be misrecognized as reflected waves of different wavelengths and amplitudes, resulting in misrecognition of the blood flow state and the corresponding depth, or for example, it may be recognized as an extremely low heart rate or a decrease in pulse rate. These have an impact on the reliability of the rectal insertion detection method itself, which can acquire biological information with high accuracy.

[0009] Therefore, an object of the present invention is to provide a rectal insertion type detection device that can accurately function the sensor regardless of the state of the rectum, such as when dirt such as feces adheres to or remains in the rectum, and can acquire biological information with high accuracy.

Means for Solving the Problems

[0010] To solve the above problems, the following means are taken. The numbers or character strings of numbers and alphabets described following the following component names are symbols shown for convenience of understanding the components in the drawings, and do not themselves have any meaning or intention of limitation.

[0011] [1] The biological information acquisition device of the present invention is composed of a rod-shaped flexible shaft inserted into the body cavity from a body cavity opening such as the intestine, vagina, mouth, nose, ear, etc. of a target animal, and measures the biological information of the insertion destination by a sensor group provided in a specific installation area near the tip of the shaft head. A measurement unit (1), a processing unit (2) that performs arithmetic processing on the data obtained by the measurement, and an output unit (21) that outputs a signal of the arithmetic data by the processing unit. It is a biological information acquisition device provided with The measuring unit (1) includes a group of sensors (a combination of an optical sensor S2, a temperature sensor S1, an acoustic wave sensor, an electric wave sensor, an infrared sensor, an electromagnetic wave sensor, an electrocardiogram electrode, a vibration sensor, and an image sensor) arranged in close proximity to each other within a specific installation area on a specific circumferential side surface of the flexible shaft or on the head of the shaft at the tip thereof, the sensors contacting a wall of a body cavity into which the flexible shaft is inserted (an internal wall of the body, for example, a rectal wall) to detect detection values ​​and measure biological information, The flexible shaft is characterized by being provided with a "wiping cover (3)" consisting of a belt-like or hat-like covering body around the head of the shaft, excluding the specific installation area. The wiping cover (3) is a band- or hat-shaped cover body that includes the axial range of the installation area of ​​the flexible shaft portion 12 and covers the cover area at the tip side of the shaft head excluding the installation areas of the optical sensor S2 and the temperature sensor S1, and comes into contact with and wipes the inner wall of the body cavity, and has a wiping function on its surface. This wiping cover 3 comes into contact with the body cavity wall of the insertion destination and wipes away lump or film-like foreign matter, excluding it from the body cavity wall within the detection range of the detection unit.

[0012] [2] The installation area including each sensor is configured as a single horizontally or vertically elongated flat circular installation area having a closed shape, The wiping cover (3) is made of a napped brush or wiping cloth and has a window portion 3H shaped to fit the flat circular installation area. Wipe the area around the window 3H with a nap brush or cleaning cloth, and A plurality of sensors are arranged in the axial direction within the window portion 3H at various positions on the axis of the rod-shaped flexible shaft, and are characterized by detecting the body cavity wall surface in contact or without contact.

[0013] The inside of the window 3H may be left open, or a part of the window 3H may be covered with a light-transmitting sheet.

[0014] [3] In the biological information acquisition device according to any one of the above, the wiping cover (3) is formed of a hat-shaped or band-shaped circumferential body that is circumferentially attached to the entire circumferential direction of a predetermined axial range at the tip of the flexible shaft, and can be detached from the flexible shaft by deforming the hat-shaped or band-shaped shape of the circumferential body. Also, by selecting and attaching one of a plurality of wiping covers provided in advance and then detaching the attachment, other wiping covers can be exchanged and attached.

[0015] [4] In the biological information acquisition device according to any one of the above, at the shaft head at the tip of the flexible shaft, a light emission irradiation unit that emits light to irradiate the surroundings outside the shaft and an imaging camera are provided, and a sensor group composed of a combination of a plurality of sensors among 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 is provided in the installation area on the side surface of the flexible shaft.

[0016] While irradiating the surroundings outside the shaft with light from the light emission irradiation unit and imaging the light emission irradiation range with the imaging camera, and acquiring measurement values with each sensor of the sensor group, the measurement values acquired simultaneously with the imaging data obtained by visually recognizing the state inside the body cavity by irradiation are output to the output unit together with the video of the imaging data.

[0017] Also, together with the light emission irradiation and the imaging of the camera, while sending out a cleaning liquid, each sensor of the optical sensor and the temperature sensor detects a measurement value, determines the presence or absence of an abnormal measurement state based on the detected value, and outputs a signal of this determination result together with the detected value of each sensor to the output unit as the calculation data.

[0018] [5] In the biological information acquisition device according to any one of the above, the shaft tip is composed of a transparent or translucent cover, and the light emission irradiation unit is built inside the cover at the shaft tip.

[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. Together 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 calculation 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 calculation 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 to the flexible shaft by wire or wirelessly. The notification unit receives the calculation data output as a signal by the output unit by wire or wireless connection, Detected value displays the above, and notifies the determination result of the abnormal measurement state by a notification means such as 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 and discontinuous measurement function for intermittently or continuously measuring information on the blood flow of the tissue within the body cavity wall (oxygen saturation or tissue oxygen saturation) over a predetermined time. By storing the continuous and discontinuous measured values of the blood flow information together with the time code by this optical sensor, it is determined whether the continuous and discontinuous 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 determined.

[0023] [9] In the biological information acquisition device according to any one of the above, a measurement surface is formed by a flat surface or a gently curved surface on a specific circumferential direction of a flexible shaft, and a blood flow sensor targeting a blood flow component on the inner wall of a body cavity, a sensor for detecting the temperature or pressure in the body cavity, and a tip irradiation light emitting unit are provided side by side at axially adjacent positions.

[0024]

[10] It is characterized in that a tip swelling part composed of a convex rotating body or a prolate spheroid shaft head and incorporating a sensor group composed of a combination of a plurality of types among 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, and a shaft part extending in a rod shape are in contact and joined by an attachment structure or are removably combined. [Advantages of the Invention]

[0025] By taking the above measures, it is possible to perform more accurate and precise measurement by wiping the periphery of the measurement part with a cleaning cover to exclude dirt such as feces and then detecting in a state where the dirt is excluded.

[0026] In addition, by making the cleaning cover replaceable or the shaft part itself replaceable, it is possible to suppress the occurrence of hygienic problems such as the adhesion and infection of bacteria in the living body.

[0027] In particular, by configuring the cylindrical surface of the cleaning cover with a raised brush or a water-absorbing cloth having a water-absorbing function, it is possible to exclude the dirt in the intestine while absorbing water, wipe the inner wall surface of the intestine, and detect the wiped inner wall surface of the intestine immediately afterwards, so that measurement can be performed without being affected by wiping and exclusion. [Brief Description of the Drawings]

[0028]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Mode for Carrying Out the Invention

[0029] Hereinafter, embodiments for carrying out the present invention will be described together with the respective figures shown as examples. The biological information acquisition device of the present invention is an in-body cavity insertion type detection device or measurement device that is inserted into the anus, vagina, nasal cavity, oral cavity, ear (referred to as "body cavity") of a target animal to detect biological information inside the body, and calculates or estimates a measurement value based on the detected value and outputs it. Target animals include domestic animals such as dogs and cats, and livestock animals such as cows and horses. The biological information includes electrocardiogram waveform information (for example, P wave, QRS wave, presence or absence of arrhythmia, movement of the myocardium, etc.) or blood pressure-related information (pulse pressure, propagation speed to the measurement site, hardness of blood vessels, stenosis / plaque amount of blood vessels, blood flow volume / blood flow speed, information on changes in blood pressure based on these (short-term temporal changes), and blood pressure), as well as information on sound and vibration. (Device Configuration) As a specific device configuration of the biological information acquisition device of the present invention, A measurement unit (1) composed of a rod-shaped flexible shaft that is inserted into the body cavity of a target animal for measurement, A processing unit (2) that performs arithmetic processing on data obtained by measurement, an output unit (21) that outputs a signal of the arithmetic data by the processing unit, and a wiping cover (3) made of a cover body that covers the periphery of the shaft head excluding the specific installation area of the flexible shaft of the measuring unit 1. The measurement unit (1) uses the tip of the shaft head 11 at the tip of the flexible shaft part 12 or / and the side surface in a specific circumferential direction as the installation area, and in this installation area, each detection part of a sensor group composed of a plurality of types of sensors that contact the inner wall of the body cavity and detect detection values is arranged close to each other. The wiping cover (3) is a strip-shaped or hat-shaped cover body that covers the "cover area" on the front side of the shaft head at the axial position of the installation area of the flexible shaft part 12 or the axial position before and after it, and excluding the installation area of the detection range by the sensors of the sensor group. It contacts and wipes the inner wall of the body cavity, and each detection part of the sensor group contacts and detects the wiped inner wall of the body cavity to acquire biological information. The acquired biological information is converted into output data through arithmetic processing by the processing unit, and is output as a signal in the form of image data and audio data by the output unit. Note that the output unit is attached to or communicatively connected to the processing unit 2.

[0030] And the biological information acquisition method by the biological information acquisition device of the present invention is A device for inserting a flexible shaft into a body cavity such as the rectum or vagina of a target animal to acquire biological information, a step of wiping off the deposits on the body cavity wall at the insertion tip by a wiping cover provided with a predetermined cover area of the flexible shaft and excluding them from the detection range; a step of acquiring biological information consisting of a sensor group, in which each sensor of the sensor group in the installation area on the side surface of the flexible shaft acquires first biological information (at least one or more pieces of information such as oxygen saturation, oxygen saturation waveform, tissue oxygen saturation, tissue oxygen saturation waveform, pulse rate, body temperature) from the body cavity wall after wiping; a step of processing the acquired biological information as output information by the processing unit; The steps consisting of the step of outputting output information by an output unit are performed in order or at overlapping simultaneous timings.

[0031] Furthermore, a biological information acquisition method using a biological information acquisition device having an issuing company unit and an imaging camera at the tip of a flexible shaft performs a cleaning step.

[0032] Moreover, a biological information acquisition method using a biological information acquisition device having a cleaning nozzle at the tip of a flexible shaft and a feeding device connected thereto performs a cleaning step.

[0033] (Cleaning cover) The cleaning cover 3 is composed of a cylindrical body having a raised brush or a water-absorbing cloth on its surface, and has a window portion 3H in a shape along the flat circular installation area at a location corresponding to the installation area in the cylindrical body. The opening edge of the window portion 3H and the raised brush or cleaning cloth on the side surface of the cylindrical body around the window portion 3H perform cleaning while absorbing water. An optical sensor and a temperature sensor are arranged in the window portion 3H.

[0034] Also, the cleaning cover (3) is composed of a hat-shaped or ring-shaped circumferential body that is detachably circumferentially mounted in the entire circumferential direction within a predetermined axial range at the tip of the flexible shaft, enabling the replacement of a plurality of cleaning covers.

[0035] Also, as in Embodiment 4 shown in FIG. 5 and Embodiment 5 shown in FIG. 6, at the tip crown portion of the tip swelling portion of the flexible shaft of the biological information acquisition device, there may be a light-emitting irradiation portion that emits light around the outside of the shaft and an imaging camera, and the captured image in the store is displayed as a video in real time by an output unit.

[0036] Also, as in Embodiment 4 shown in FIG. 5 and Embodiment 5 shown in FIG. 6, in the biological information acquisition device, the tip of the shaft may be composed of a transparent or translucent cover, and the light-emitting irradiation portion may be built inside this tip cover of the shaft.

[0037] In the biological information acquisition device according to any one of the above, the processing unit determines the presence or absence of an abnormal measurement state based on the detection values of each of the optical sensor and the temperature sensor, and outputs a signal to the output unit as the calculation data together with the detection values of each sensor and the determination result.

[0038] In the biological information acquisition device according to any one of the above, the device further includes a notification unit that is connected to the flexible shaft by wire or wirelessly. The notification unit receives the calculation data output as a signal by the output unit through a wired or wireless connection, displays the sensor detection value, and notifies the determination result of the abnormal measurement state by means of sound, light, or display.

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

[0040] (Measurement unit (biological information acquisition device composed of a flexible shaft 1)) The shaft head 11 at the tip of the flexible shaft portion 12 of the biological information acquisition sensor has an elliptical spherical bulging body shape. When this measurement unit is inserted into the rectum, the side surface of the measurement unit contacts the body cavity wall (for example, the rectal wall, vaginal wall, nasal cavity wall, ear cavity wall, or oral cavity wall). Sensor group (a combination of a plurality of optical sensor S2, temperature sensor S1, acoustic wave sensor, radio wave sensor, infrared sensor, electromagnetic wave sensor, electrocardiogram electrode, vibration sensor, and image sensor) More specifically, a flexible shaft extending in a rod shape and an elliptical spherical bulging body-shaped measurement unit at its tip are connected in a uniaxial direction to form a rectal inserter. Among this measurement unit, a detection unit is embedded in the side surface of the most bulging maximum diameter portion. It is made of an elastically deformable resin body, and a sensor is embedded in a part thereof. The casing of the processing unit is integrally or wired-connected to the base of this rectal inserter, and a detection signal by the detection unit or a signal of current information by the contact of the electrode terminal is sent to the processing unit.

[0041] The measurement unit consists of a rod-shaped flexible shaft 1 that can be inserted into the rectum, vagina, ear, or nose of the target animal. On the same specific circumferential direction of the flexible shaft, a blood flow sensor (reflective pulse oximeter) 110S that detects contact with the inner wall of the body cavity (targeting the blood flow components of the inner wall of the body cavity) and a temperature sensor S1 are arranged axially side by side so as to face the same specific circumferential direction (Figure 1a). Here, the same specific circumferential direction that they share with each other refers to a specific phase direction around the axis (the direction of the lead line numbered 31 in Figure 1d) in the axial plane view as shown in Figure 1d.

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

[0043] The shaft head 11 is provided at the axial tip of the shaft part 12 having flexibility that can be elastically deformed, making it a rod shape with a swollen tip, and the tip of the shaft head 11 is a bullet-shaped shaft head.

[0044] (Attachment structure) In the embodiment, attachment structures 121 and 122 corresponding to each other are provided at the base of the shaft head 11 and the tip of the shaft part 12 respectively. By bringing the end faces of one attachment structure 121 and the other attachment structure 122 into contact with each other and rotating them in one direction so that the locking protrusion 121C of one attachment structure 121 and the locking groove 122D of the other attachment structure 122 are locked, the attachment structures are brought into contact and joined to be in a combined state. This combined state can be removed by rotating them relative to each other in a specific direction (Figure 3).

[0045] (Cleaning cover 3) In the embodiment, further provided is a wiping cover 3 that integrally covers at least a part of the shaft head 11 at the tip of the flexible shaft, the axial position of the detection range of the sensor group (S1, S2), and / or the cover area ahead thereof. The wiping cover 3 is composed of an elastically deformable resin molded body such as EVA resin in which a hemispherical portion 31 that covers the hemispherical portion which is the narrowed portion at the tip of the shaft head 11, a cylindrical portion 32 that is peripherally attached to the cylindrical portion of the shaft head 11, and an annular end portion 32E of the cylindrical body 32 are connected. Among these, in the cylindrical portion 32, a window portion 3H having a size corresponding to the installation area of the sensor is formed, and the surface of the cylindrical body around the window portion 3H is composed of a water-absorbent wiping body made of a flocked cloth, a wiping cloth, or a cloth with brush hairs. The tip may also be composed of a water-absorbent wiping body.

[0046] The inner diameter of the said "wiping cover" is made to be the same as or slightly larger than the diameter of the flexible shaft, facilitating the removal of the "wiping cover" after insertion into the rectum.

[0047] The measurement surface of the installation area provided with each sensor is composed of an area in the shape of a single flat circle (elliptical shape or oval shape) (horizontally long or vertically long). The wiping cover is composed of a flocked brush or a wiping cloth and has a window portion 3H in the shape along the flat circular installation area, and the measurement surface of the installation area is exposed within this window portion 3H. The wiping cover is provided with a wiping cloth or a wiping brush at least along the periphery of the window portion 3H, and the detection surface in the body cavity facing the measurement surface of the installation area within the window portion 3H is wiped by these flocked brushes or wiping cloths.

[0048] Note that the inside of the window portion 3H of the wiping cover may remain open, or a part of it may be covered with a light-transmitting sheet.

[0049] The hemispherical portion 31 and the cylindrical portion 32 that constitute the cleaning cover 3 may be configured as an integral part connected as in Example 1 (Figs. 1 and 2) or Example 3 (Fig. 4), or may be configured as separate parts that can be connected by overlapping the connecting end portions of the ring bodies as in Example 2 (Fig. 3). Also, like Example 3 (Fig. 4), it may be in a form that can be deformed into a compact short cylindrical bag body by turning the end opening inside out and winding it around.

[0050] (Contact type sensor group) On the shaft head portion 11 of the flexible shaft, a measurement surface 11F of a flat installation region is provided which is formed as a flat surface or a gently curved surface in a specific circumferential direction and the periphery of the surface is formed into a rounded edge portion, and on this flat installation region's measurement surface 11F, a sensor group composed of contact type or non-contact type sensors targeting the blood flow information of the inner wall of the body cavity is provided. The sensor group composed of contact type sensors is composed of any plurality of types among contact type optical sensors, temperature sensors for acquiring various information of the inner wall of the body cavity, acoustic wave sensors, radio wave sensors, infrared sensors, electromagnetic wave sensors, electrocardiogram electrodes, and vibration sensors, and the non-contact type sensors are composed of either non-contact type optical sensors or image sensors. The sensor group used in the present invention is composed of a combination of any plurality of these types of sensors.

[0051] The contact type sensor group of the embodiment consists of a temperature sensor S1 having a detection portion composed of a circular transparent window and a reflective pulse oximeter S2 having a detection portion composed of a square transparent window. They are arranged side by side in the axial direction so as to face the same circumferential direction, that is, a specific lateral direction. In the 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 be further combined. Based on the measured values of each sensor considered to be correlated, a comprehensive determination is made as to whether it is in an abnormal measurement state. By the measurement surface 11F of the installation region formed as a flat surface or a gently curved surface and the cleaning cloth that covers the periphery thereof in an edge shape, foreign matter can be removed from near the measurement surface, and the measurement surface can be stably brought into contact with the inner wall of the body cavity. Also, by arranging them side by side 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 reflection / transmission type sensor can be used. By utilizing the difference in light transmittance / reflection rate, light emission at multiple wavelengths is received by a light receiving sensor, and the light intensity and wavelength of the reflected light / transmitted light are measured, thereby comparatively measuring the light transmittance of the reflection signals of the blood flows in the arteries and veins on the inner wall of the body cavity in contact with the sensor. In the embodiment, a reflection type pulse oximeter is used, and an electrocardiogram waveform is acquired based on the principle of discriminating between arterial blood and venous blood by the optical sensor and measuring the oxygen saturation of arterial blood.

[0053] (Detection of abnormal measurement state) The detection of an abnormal measurement state (discrimination of the presence or absence of an abnormal state) refers to discriminating an abnormal state of close contact with the rectum (such as light interference from feces or the like, or whether the adhesion force to the intestinal wall is within the normal measurement range), or a measurement abnormality due to an unexpected body movement (whether it is a state where measurement cannot be performed due to body movement).

[0054] The detected value (whether it is possible to specify a pulsation peak (the value cannot be obtained), whether the peak value is within a predetermined threshold range, and whether it has a certain rhythm synchronized with the heartbeat (the variation of the value per unit time due to a sharp increase and decrease)) is discriminated. For example, an undercount of the pulse due to poor contact (a measurement impossible state due to a low value), an abnormal value of the measurement due to excessive body movement, and discontinuity of the measurement value due to a time change (a sudden abnormal value of the heart rate due to double counting) can be cited. For example, a change (variation amount) per unit time of about 1 second being more than twice that of normal is an obvious abnormal change amount per unit time.

[0055] The temperature sensor S1 measures the temperature of the body tissue in contact with the sensor by a thermometer, and discriminates the stability of the measurement based on whether the measured value of the thermometer is within the normal range and the variation amount per unit time. For example, an obviously abnormal measured value depending on the target animal or an obvious abnormal variation amount per unit time of about 1 second is set in advance as an input, and it can be discriminated that it is in an abnormal measurement state when it exceeds this set value.

[0056] (Unexpected body movement) Causes of abnormal measurement states include unexpected body movements and foreign matter contamination. Due to the need for animal restraint, differences in posture, and inadequate fixation by the tail, animals may be in a state where unexpected body movements occur unintentionally by the measurer. In this state, appropriate SPO2 measurement cannot be performed. In response, in the present invention, a flat measurement surface 11F for contact measurement, which is substantially planar in a specific circumferential direction of the shaft head, is formed, and the processing unit main body 2 is operated so as to press this flat measurement surface 11F against the rectal wall, and measurement is performed by closely adhering the inflated flat measurement surface 11F of the shaft head to the intestinal wall (Fig. 5). Thereby, it is made easy to maintain a normal measurement state even in the case of unexpected body movements. In addition, by measuring in the rectum, measurement errors due to light interference, pigment deposition, and the influence of body hair do not occur in the first place.

[0057] The processing unit 2 of the present invention has a step of analyzing whether the electrocardiogram waveform obtained by a reflection type pulse oximeter (blood flow sensor S2) incorporated in a flexible shaft repeats regular time variations within a predetermined distortion range to determine a normal measurement state. This utilizes the principle that, as long as there is no arrhythmia, it synchronizes with the electrocardiogram waveform in a normal measurement state without body movement or fecal interference.

[0058] (Processing unit 2) The processing unit is a part that performs arithmetic processing on the data obtained by the measurement of the measurement unit. The processing unit in the embodiment is incorporated in a thin rectangular parallelepiped-shaped processing unit main body 2, and this processing unit main body 2 is configured integrally with the flexible shaft 1. As the arithmetic processing, it is characterized in that false detection is eliminated by determining the state of close contact with the rectum, that is, the presence or absence of an abnormal measurement state is determined based on the detection values of each sensor. In the embodiment, an output unit is further incorporated in the thin rectangular parallelepiped-shaped processing unit main body 2. The processing unit component body 2 of the embodiment incorporates a processing unit and an output unit inside, and further includes a display unit 21 for liquid crystal displaying processing data on the front, an acquisition unit 23 for authentication data, and a speaker (not shown) for notifying an abnormal state. A switch 25 and two buttons 24 that also serve as a lock button and a setting button are provided on the end side surface. A knob-equipped cover plate 26 for replacing the built-in battery and memory is incorporated on the back.

[0059] The determination of the presence or absence of an abnormal measurement state is performed, for example, by whether or not a pulsation peak can be specified, whether the peak value is within a predetermined threshold range, whether it has a certain rhythm to be synchronized with the electrocardiogram waveform, and whether the detected value of the temperature sensor is a normal value.

[0060] More specifically, it has a continuous and discontinuous measurement function of intermittently or continuously measuring the tissue oxygen saturation of the microvessels in the rectal tissue for a predetermined time, and stores the measurement values together with the time code, thereby determining whether the SPO2 sensor detection value falls within a predetermined threshold range of a certain fluctuation pattern, and determining the disturbance of the waveform due to body movement or posture change.

[0061] (Estimation step based on synchrony) In the determination of an abnormal measurement state, an estimation step of a normal measurement state based on the synchrony of the value changes of SPO2 and temperature can be included. Generally, there is a correlation between the value changes of SPO2 and temperature. By judging the correlation of the value changes of SPO2 and temperature, it can be determined that it is in a normal measurement state. Also, based on the heartbeat change that is not linked to the body temperature fluctuation, it can be determined that it is in an abnormal measurement state. That is, the body temperature fluctuation is generally due to inflammation, and the heartbeat should also increase in conjunction, but if it is not linked, there is a risk of abnormal measurement state. On the other hand, if only either the heartbeat (circulation function) or SPO2 (lung function) is an abnormal value despite the normal body temperature, it can be determined that there is a high possibility of being in a normal measurement state.

[0062] In the processing step by the processing unit, Based on the potential difference between the electrode terminals in the rectum and each attachment location, an electrocardiogram waveform is acquired, the heart rate is acquired from the R - R interval of the electrocardiogram waveform, and the heart rate as output information is processed.

[0063] Also, in the said processing step, The change in the electrical resistance value between the electrode terminals, the change in the R-R interval of the continuous electrocardiogram waveform, or separately, the respiratory rate is obtained from the respiratory waveform and the waveform peak interval from a sensor attached to the rectum, skin, or mucosa, and the respiratory waveform, electrocardiogram waveform, or information readable from the respiratory rate, heart rate, respiratory waveform, and electrocardiogram waveform, as well as information on diseases and health status, is processed as output information.

[0064] The first biological information obtained by the biological information acquisition sensor includes at least one or more of oxygen saturation, oxygen saturation waveform, tissue oxygen saturation, tissue oxygen saturation waveform, pulse rate, and body temperature.

[0065] When the additional detection unit includes a second biological information acquisition sensor, the second biological information obtained thereby is at least one or more of oxygen saturation, oxygen saturation waveform, tissue oxygen saturation, tissue oxygen saturation waveform, pulse rate, and body temperature at the attachment location of the additional detection unit, and consists of information of the same type as the first biological information. By continuously obtaining biological information of the same type as the first biological information at a plurality of locations by the additional detection unit, it is possible to estimate whether the value of the obtained biological information is a correct value.

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

[0067] The output processing of the "blood pressure-related information" may be to obtain an oxygen saturation waveform or a tissue oxygen saturation waveform at two or more different sensor placement parts, and calculate and process "changes in pulse wave propagation velocity or pulse wave propagation time" based on the comparison of each waveform and the electrocardiogram waveform. That is, when a plurality of locations where the biological information acquisition sensor is placed among a plurality of attachment locations or the rectum of the target animal are used as the sensor placement parts, at each sensor placement part, "oxygen saturation waveform or tissue oxygen saturation waveform, that is, saturation waveform" is obtained respectively, Based on the waveform shapes of each oxygen saturation waveform or tissue oxygen saturation waveform obtained 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 the variations thereof, an estimated blood pressure value or "blood pressure-related information", which is information related to blood pressure fluctuations, is obtained as output information.

[0068] (Output processing of "artery-related information") Also, "oxygen saturation waveform or tissue oxygen saturation waveform" is obtained as the first biological information and the second biological information at two or more different sensor placement units, the electrocardiogram waveform which is electrocardiogram information is obtained, and by comparing between each sensor placement unit, "artery-related information", which is any one or more of information such as the degree of arteriosclerosis or flexibility, stenosis or occlusion, or bleeding information of the artery from the heart to each sensor placement unit, can be processed as output information.

[0069] That is, in the processing step, the processing unit, based on the waveform shapes of each oxygen saturation waveform or tissue oxygen saturation waveform obtained at two or more different sensor placement units, 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 the variations thereof, calculates "changes in pulse wave velocity or pulse wave propagation time", and processes, as output information, one or more of information such as the degree of arteriosclerosis or flexibility, stenosis or occlusion information, or information related to artery bleeding of the artery from the heart to each sensor placement unit where biological information is obtained.

[0070] When processing the first biological information obtained in the rectum and the second biological information obtained at each of a plurality of attachment locations, if the biological information values of the same type obtained at a plurality of locations are significantly different, the measurement accuracy or the normality of the measurement state is obtained as output information from the comparison between the variation of the oxygen saturation with other biological information fixed values and the variation of the electrocardiogram waveform by the electrocardiogram electrodes.

[0071] When respiratory waveform information is obtained based on resistance value information from the electrode terminals of the additional detection unit due to high-frequency current, information on the respiratory rate is acquired as output information using the variable length of the time interval between consecutive heartbeats in the respiratory waveform information.

[0072] (Example 1) The biological information acquisition device according to Example 1 of the present invention shown in FIGS. 1 to 2 is inserted into the body cavity of a target animal, and is in contact with the body cavity wall at the insertion tip, and has a rod-shaped flexible shaft (shaft base 11, flexible shaft portion 12, shaft head 13) provided with a sensor group near the tip thereof, a measurement unit 1 composed of a box-shaped housing configured integrally with the flexible shaft 1, and a processing unit 2 that performs arithmetic processing on the data obtained by the measurement; a display unit 21 that is provided on one side surface of the box-shaped housing of the processing unit 2 and outputs the output data after the arithmetic processing as a signal; a transmitter 27 that is provided near the base of the box-shaped housing of the processing unit 2 and outputs the output data after the arithmetic processing as a signal by transmission; and a "cleaning cover 3" composed of a cover body that covers the periphery of the shaft head except for the specific installation area of the flexible shaft of the measurement unit 1.

[0073] And the biological information acquisition display system according to Example 1 of the present invention shown in FIG. 1 includes the biological information acquisition device, a portable terminal device 28 having an output unit 281 that receives and displays the data transmitted from the transmitter 27 of the biological information acquisition device, a data server 4 that receives and stores the data by existing communication means, and a processing terminal device 51 that transmits and receives data to and from the data server 4, displays the data on a display unit 51, inputs the accessory information of the data at an input unit 52, processes the data into management data, and stores the management data together with the data server 4, and a portable terminal device 61 having an output unit that receives and displays the data from the data server 4.

[0074] The measurement 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 having a cylindrical cross section are connected in order in the linear axis direction, It is composed of a sensor group S1, S2 built into the shaft head 11 of the flexible shaft, and the detection parts of the sensor group are collectively provided within a specific installation area in a specific circumferential direction 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 is formed of a narrow conical frustum protruding laterally. A fine-hole-shaped sensor terminal hole 13C is provided on the top surface of the conical frustum, and a sensor terminal bar 12C can be inserted and connected into the hole (Fig. 2).

[0076] The middle part of the flexible shaft consists of a flexible shaft part 12 in the shape of a cylindrical rod. The cylindrical rod of this flexible shaft part is composed of an elastic rod whose axis, that is, the axis of the extending cylindrical axis, can be elastically bent. Inside the elastic rod, a communication line for transmitting detection information from the shaft head at the tip is built in along the axial direction, that is, the extending direction. The base end part of the flexible shaft part 12 consists of a short connecting part whose diameter expands conically, and a sensor terminal bar 12C made of an angular rod protrudes from the center of the end part of the connecting part. The sensor terminal bar 12C is inserted into the sensor terminal hole 13C of the shaft base 11, so that it is connected to the communication line inside the flexible shaft part 12 in a signal-transmissible manner, and transmits the detection information by the sensor group to the sensor terminal hole 13C.

[0077] The tip part of the flexible shaft consists of a shaft head 11 formed in a capsule shape that bulges to have a larger diameter than the flexible shaft part 12. The shaft head 11 is integrally composed of a conical diameter-expanding part that expands in diameter at the tip of the flexible shaft part 12 to have a larger diameter than the flexible shaft part, a cylindrical part with a larger diameter than the flexible shaft part, and a tip part of a cylindrical body rounded into a semi-spherical shape. On a specific side surface in the axial direction of the cylindrical body of the shaft head 11, a measurement surface of an elliptical plane that is long in the cylindrical axis direction of the cylindrical body is formed, and the detection parts of a sensor group composed of a plurality of sensors (S1, S2) are provided side by side within the measurement surface of this installation area.

[0078] The sensor group is a group of sensors composed of multiple types of sensors that contact the body cavity wall (inner wall of the body, such as the rectal wall) at the insertion site and detect multiple types of detection values. The sensor group of 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 provided at adjacent positions arranged on the axis of the flexible shaft within an elliptical installation area.

[0079] (Processing unit 2) The processing unit 2 of Example 1 is a part that performs arithmetic processing on the data obtained by the measurement of the measurement unit. The processing unit of the example is built into a thin rectangular parallelepiped-shaped box-shaped housing. This box-shaped housing 2 is provided with a display unit for indicating detection information and abnormal / property detection status, and a display button.

[0080] The cleaning cover (3) is a strip-shaped or hat-shaped cover body (hat-shaped part 31, strip-shaped part 32) that includes the axial range of the installation area of the flexible shaft part 12 and covers the cover area on the front side of the shaft head excluding the installation areas of the optical sensor S2 and the temperature sensor S1. The cover body of the cleaning cover 3 of the example is integrally formed by a hemispherical hat-shaped part 31 that bulges spherically forward and a cylindrical strip-shaped part 32 connected to the base of the hat-shaped part 31. Among them, the entire surface of the strip-shaped part 32 is made of a cleaning cloth, and the cleaning cloth is subjected to fluffing processing and has a cleaning function and a water absorption function.

[0081] (Measurement unit) The cleaning cover of Example 2 shown in FIG. 3 is composed of a cap-shaped cover body with a semi-elliptical spherical tip and a cylindrical side cover body. The end portions 32F of each cover body are combined so as to overlap each other and are attached to the shaft head for use. The side cover body has a strip-shaped formal cloth on its surface that contacts the body cavity wall at the insertion site and cleans around the shaft head excluding the specific installation area of the flexible shaft. The tip cover body is made of an elastic resin body, and the cylindrical side cover body is made of a stretchable cleaning cloth body. The thickness 311T of the tip head of the cap-shaped tip cover body is designed to be 150% or more and 200% or less than the side thickness 32F.

[0082] The measuring unit (1) of Example 2 shown in FIG. 3 is the same as that of Example 1. A flexible shaft in which a shaft base 13, a flexible shaft portion 12, and a shaft head 11 having a cylindrical cross section are connected in order in the linear axis direction, It is composed of sensor groups S1 and S2 built in the shaft head 11 of the flexible shaft and provided with the detection units gathered in a specific installation area in a specific circumferential direction or tip direction of the shaft head 11. However, the measurement surface of the installation area of the shaft head 11 in the measuring unit of Example 2 is an oval shape capable of arranging the detection units of two or more sensors, and the detection units of two sensors are arranged in the measurement surface of this installation area.

[0083] A sensor group (a combination of a plurality of optical sensors, temperature sensors, acoustic sensors, radio sensors, infrared sensors, electromagnetic wave sensors, electrocardiogram electrodes, vibration sensors, and image sensors) that contacts the body cavity wall (inner body wall, for example, rectal wall) of the insertion tip and detects a detection value is provided side by side in close proximity to a specific installation area in a specific circumferential direction or at the shaft head at the tip of the flexible shaft.

[0084] The "cleaning cover" of Example 3 shown in FIG. 4 can be deformed into a compact short cylindrical bag body by turning the resin long bag-shaped end opening shown in FIGS. 4(a), (c), and (d) inside out and winding it around the outer surface of the bag tube. Further, the shaft head, which is the measuring unit of Example 3, is integrated with the flexible shaft and consists of a rod-shaped flexible shaft in which the shaft head does not have a swelling portion. That is, the shaft head of Example 3 consists of a cylindrical rod having an outer diameter corresponding to the inner diameter of the long bag-shaped cleaning cover, and the tip thereof is hemispherical.

[0085] The wiping cover of Example 3 is composed of an elongated bag-shaped adherend made of an elastic body having a window portion 3H on the side surface. Here, the elongated bag shape means a shape in which the tip is narrowed to form a bag bottom, and an opening end portion 33, which is the base of a cylindrical tube extending in a cylindrical shape, is formed as the opening of the bag mouth. The bag mouth portion has an opening end portion 33 of an annular ring body that bulges outward from the outer shape of the tube of the tube body. By winding this opening end portion 33 around the tube body side and folding it back in order, the length of the bag tube portion 32 can be adjusted. Also, the portion in contact with the body cavity wall surface is wound inward and housed, and it is deformable into the form of a short tube bag body and can be removed. By winding the surface of the bag tube in this way and removing it in the form of a short bag shape, the wiping cover can be replaced while preventing hygienic problems.

[0086] Note that the tip portion 31, which is the bag bottom of the wiping cover of Example 3, is composed of a resin material with a variable thickness that gradually becomes thicker than the peripheral side portion. When inserted into the body cavity such as the vagina or intestine, the tip can elastically deform and contact, and the relatively thick resin tip portion 31 enables smooth insertion. Also, the bag hole of the wiping cover of Example 3 at the opening end portion is formed with a circular cross-section, and its inner diameter is made larger than the diameter of the flexible shaft, making it easier to remove the "wiping cover" after insertion into the rectum.

[0087] At the shaft head at the tip of the shaft, a light-emitting irradiation portion that emits light and irradiates the surroundings around the shaft, an imaging camera, Or, it is characterized by having the sensor group (a combination of a plurality of 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).

[0088] In Example 4 shown in FIG. 5, the tip of the shaft head 11, which is the tip of the measurement portion, is composed of a transparent or translucent hemispherical cover, and the light-emitting irradiation portion with an imaging camera is built inside the cover at the tip of this shaft, facing the tip side in the axial direction. Example 4 shown in FIG. 5 is a form in which the light-emitting irradiation portion with an imaging camera is installed facing the axis, that is, the tip direction. The wiping cover is composed of a bag-shaped elastic resin having translucency that covers the entire shaft head 11.

[0089] The cleaning cover is mounted in the same manner as in Example 3, in a deployed state where it is extended from a shortened state in which the end opening 33 is wound around so as to cover the entire axial direction of the shaft head. The cleaning cover mounted in the deployed state has an oval window portion in a specific side surface direction, and the detection portions of the sensor group are exposed within this window portion 3H. Also, in the mounted state, as shown in Fig. 5(a2), by causing the light emitting irradiation portion of Example 4 to emit light with the cleaning cover mounted, light is emitted to the surroundings, that is, irradiated toward the tip direction, and it is possible to image foreign matters that are difficult to pass light through the inner wall in the air with the imaging camera.

[0090] Note that the measurement unit (1) of Example 4 is, 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 having a cylindrical cross-section are connected in order in the linear axial direction, and a sensor group S1, S2 incorporated in the shaft head 11 of the flexible shaft and provided with detection portions gathered within a specific installation region in a specific circumferential direction or tip direction of the shaft head 11.

[0091] In Example 5 shown in Fig. 6, the tip of the shaft head 11, which is the tip of the measurement unit, is constituted by a transparent or translucent hemispherical cover, and the light emitting irradiation portion with an imaging camera is built into the inside of this shaft tip cover facing laterally with respect to the axial direction. The light emitting irradiation portion with an imaging camera of Example 5 is installed in a form facing a specific side surface direction in which the detection portions of the sensors are arranged, and the cleaning cover is constituted by an elastic resin bag-shaped body that covers the entire shaft head 11, and the entire periphery thereof is covered with a cleaning cloth by raising the nap.

[0092] In addition, the side portion of the cylindrical body has an oval window portion 3H, and a tip window portion 31A formed of a substantially trapezoidal opening is provided in the vicinity of the front side of the window portion 3H at the corresponding position of the light-emitting irradiation portion. The opening end portion 33E is made of an elastic ring body corresponding to the diameter of the flexible shaft portion 12, and the opening end portion 33E is elastically adhered to the conical base portion of the shaft head portion 11 in a state where the cleaning cover is attached to maintain the attached state. Further, by causing the light-emitting irradiation portion of Example 5 to emit light, the periphery is irradiated from the opening of the tip window portion, and the irradiation portion is imaged by an imaging camera and displayed on the display portion in real time, or the captured video is recorded. The cleaning portion is irradiated toward the light-emitting tip, that is, the irradiation direction on the side portion, and a foreign object that is difficult to transmit light through the inner wall of the stationary air is imaged by the imaging camera.

[0093] In Example 6 shown in FIG. 7, a cleaning liquid injection nozzle 15 is provided on the front side of the installation area including the sensor group and the detection portions of the optical sensor S2 and the temperature sensor S1. The injection nozzle 15 includes a cleaning liquid delivery device (25S, WH, WT) communicated through an internal liquid pipe. Specifically, the injection nozzle 15 includes a liquid pipe 153 installed along the axis of the shaft head of the measurement unit 1, an orifice portion 152 that bends and accelerates the delivery direction at the tip of the liquid pipe 153, a spherical water stop valve 152B installed in the orifice portion 152, and a nozzle outlet 151.

[0094] Further, the liquid pipe 153 communicated through the flexible shaft is connected to a delivery amount adjustment device (not shown) installed in the processing unit 2 of the housing, and is externally connected to a delivery tank WT provided with a delivery pump via an external liquid pipe WH connected through the delivery amount adjustment device (FIGS. 7 and 8). In Example 7, a delivery switch 25S of the delivery pump is provided in the processing unit 2 of the box-shaped housing. Each sensor of the optical sensor and the temperature sensor detects a measured value while the cleaning liquid is being delivered, the presence or absence of an abnormal measurement state is determined based on the detected value, and this determination result is signal-output to the output unit as the arithmetic data together with the detected values of each sensor.

[0095] Also, the tip of the measurement unit 1 in Example 6, like that in Example 3, consists of a rod-shaped body integrally formed with the same diameter as the flexible shaft without a swelling portion. The installation area of the shaft head is formed of an elliptical curved surface that demarcates a part of the measurement direction, which is a specific radial direction of a cylindrical rod shape. The rectangular detection portions of the sensors S1 and S2 are provided side by side in the portion closer to the center thereof. The rectangular nozzle portion is exposed toward the tip tooth portion side of this installation area (FIGS. 8 and 9). A long bag-shaped wiping cover 3 made of an elastic resin corresponding to the shape of the shaft head is attached so as to cover this shaft head. The open end portion can be turned inside out by winding, and by folding back and unfolding this open end portion, it becomes a long bag-shaped unfolded state. Further, on the side surface of the wiping cover in a specific direction, two openings consisting of a tip window portion and a window portion are provided at positions corresponding to the injection nozzle 15 of the shaft head and the detection portions of the sensors in the installation area.

[0096] The processing unit discriminates the presence or absence of an abnormal measurement state based on the detection values of the optical sensor and the temperature sensor, and performs processing to signal-output the discrimination result together with the detection values of the sensors as the arithmetic data to the output unit.

[0097] It further includes a notification unit connected to the flexible shaft by wire or wirelessly. The notification unit receives the arithmetic data signal-output by the output unit by wire or wireless connection, displays the sensor detection values, and notifies the discrimination result of the abnormal measurement state by means of notification such as sound, light, or display.

[0098] It has a continuous and discontinuous measurement function of intermittently or continuously measuring the information on the blood flow (oxygen saturation or tissue oxygen saturation) of the tissue within the body cavity wall over a predetermined time, and by storing the measurement values together with the time code, it discriminates whether the detection value of the optical sensor falls within a predetermined threshold range of a certain fluctuation pattern, and discriminates the disturbance of the waveform due to body movement or posture change.

[0099] Together with the tip irradiation light emitting part, a reflection type pulse oximeter and a temperature sensor targeting the blood flow component of the body cavity inner wall are arranged in the axial direction on the measurement surface of the installation area formed in a plane or a gently curved surface in a specific circumferential direction of the flexible shaft. The measurement surface of the installation area in Example 1 is an ellipse on which the detection parts of two sensors can be arranged, and the measurement surfaces of the installation areas in Examples 2, 3, and 4 are oblong shapes on which the detection parts of two or more sensors can be arranged.

[0100] It is characterized in that it consists of a convex rotating body or a shaft head of a prolate spheroid, and a tip swelling part incorporating a contact type sensor group composed of an optical sensor and a temperature sensor, and a shaft part extending in a rod shape are brought into contact and joined by an attachment structure or are removably combined.

[0101] For example, it is possible to measure each position of the body for measuring an electrocardiogram across the heart, and to compare the measurements of the lower body. By using the first potential information inside the body (inside the intestine), a waveform with less noise can be obtained, enabling highly accurate measurement.

[0102] Although there is only one type of electrocardiogram that can be obtained (only two-lead / three-lead), it can be measured simply and accurately (without noise). Since it crosses the body in the vertical direction, the body resistance is considered to be small. Since the influence of individual differences in the attachment location is small, statistical comparison is possible.

[0103] The biological information acquisition sensor (1) of Example 3 shown in FIG. 4 is attached to a measurement part composed of a rod-shaped flexible shaft that is inserted into the rectum of the target animal for measurement. The measurement part includes a blood flow sensor and a temperature sensor that come into contact with and detect the inner wall of the body cavity side by side in the same specific circumferential direction of the flexible shaft.

[0104] (Processing unit) The processing unit discriminates the presence or absence of an abnormal measurement state based on the detection values of each sensor, and outputs a signal to the output unit as the calculation data together with this discrimination result and the sensor detection values. Rather than the body surface (where there is an effect of skin resistance due to hardening), as a device for "acquiring electrocardiogram information from the intestine", an example is a sensor shaft head composed of a metal cover 11 integrally formed of a conductor. Since it is in wet contact with the organ, the electrical resistance is low, noise is less likely to be superimposed, and highly accurate measurement is possible.

[0105] (Contact-type sensor group) On the side surface of the flexible shaft, contact-type sensor groups are arranged side by side in the axial direction so as to face the same circumferential direction, that is, a specific side direction. In the embodiment, it is composed of a combination of a blood flow sensor S2 and a temperature sensor 110S, but a pressure sensor may be further combined. Based on the measured values of each sensor considered to be correlated, a comprehensive determination is made as to whether it is in an abnormal measurement state.

[0106] [3](Blood pressure-related information) The first biological information is the potential information and oxygen saturation waveform information in the intestine, The second, third,... biological information is the potential information and oxygen saturation waveform information at the terminal attachment position, The processing unit performs arithmetic processing on blood pressure-related information including changes in pulse wave velocity based on electrocardiogram waveform information and oxygen saturation waveform information, The output unit is characterized by displaying the blood pressure-related information on a display unit.

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

[0108] Rather than the body surface (where there is an effect of skin resistance due to hardening), in order to "acquire the potential information of the electrocardiogram from the intestine", since it is in wet contact with the organ, the electrical resistance is low, noise is less likely to be superimposed, and highly accurate measurement is possible.

[0109] <Operational effects of the embodiment> The present invention can provide a biological information acquisition device or a biological information acquisition method that can avoid misrecognition of data due to abnormal measurement states by taking notification means for alerting the measurement states of specific individuals. Specifically, the following operational effects can be regarded as merits. · It is difficult to measure oxygen saturation under low blood pressure or when the arterial pulsation is weak (or absent), but tissue oxygen saturation can be measured. · Since tissue oxygen saturation is a measured value that includes venule components and capillary components, it is possible to measure even microbleeding in tissues that is difficult to be reflected by oxygen saturation. · A shape for detecting intrarectal pressure, a shape that is easy to be placed in the rectum (the value is stable and it is not easily resisted by the measured animal, so it is suitable for examining (diagnosing) an animal during activity). In particular, since the shaft head of a relatively thin elastic shaft has a structure that bulges flat and old-fashioned (balloon shape), it is suitable for monitoring the depth of anesthesia. Also, it is possible to detect the occurrence of extra pain and predict a body movement accident.

[0110] <Use for anorectal manometry> Using the biological information acquisition device of the present invention, it is possible to evaluate anorectal manometry performed for detecting a state of feeling pain or diagnosing fecal incontinence.

[0111] (Inpatient and outpatient information) As a processing method of a measurement system equipped with the acquisition device of the present invention, it further includes a step of setting inpatient information or outpatient information to a hospital or a facility for a predetermined symptom of a target individual, and can output separately for data at the time of hospitalization or outpatient visit and data at home.

[0112] (Group recording of preoperative and postoperative data) It further includes a step of storing surgical information for a predetermined symptom of a target individual and group recording resting data during the preoperative or postoperative period of the target individual as attribute data of the symptom. For example, by combining the attribute groups "medical history", "surgical history", "before and after surgery", and "before and after contraception", it is possible to judge the state of postoperative progress.

[0113] (Alert output) Determine whether the transmitted data exceeds the preset upper limit value, lower limit value, and average value, and if it is detected that the value has exceeded, perform an alert output.

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

[0115] Also, it is preferable to have a collation unit that collates differences in data accumulation or measurement and individual identification using the microchip number. For example, in the processing unit main body 2, it is equipped with a reading unit 23 that acquires and authenticates the microchip data of a living animal and a collation unit that collates the read data. When performing output processing by the data storage or output processing unit in the server 4, it is possible to link the personal data PD and the treatment data MD and include a collation step for the individual identification information of the living body, such as the microchip number.

[0116] (Communication line record between the owner and the attending physician after the alert) When acquiring measurement data, output the measurement result or determination result to the owner terminal 61, the attending physician, or the hospital terminal 5. Also, in the case of normal data determination and emergency state notification due to data abnormality, it is possible to secure a character information chat or a call communication line, display that the line is available, and have a system that records the communication after using the line.

[0117] Estimation of rectal temperature: It is also possible to have a system that performs data processing by combining a wearable transmitter worn at all times and an intestinal insertion inspection device (biological information acquisition device). The data of the intestinal insertion inspection device (biological information acquisition device) temporarily inserted into the intestinal tract of the target biological individual is output to the wearable transmitter worn by the biological individual at all times, and a system can be provided with an output unit through the wearable transmitter.

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

[0119] Similar to body temperature measurement, if oxygen saturation can be measured rectally, it is possible to reduce the labor and achieve both measurement value stability and reproducibility.

[0120] According to an embodiment of the present invention, it is possible to evaluate the measured value itself as an absolute value or determine whether the measured value is normal or abnormal for the estimation device and the method for estimating blood flow information. Also, the measurement value is less likely to vary depending on the measurement conditions, measurement object, or measurer, and an acquisition device for blood pressure-related information or artery-related information that can ensure the reproducibility of the measurement value is provided.

[0121] (Measurement principle) As one form of the biological information acquisition sensor, a light-emitting type blood flow sensor can be mentioned. There are two types of light-emitting type blood flow sensors: a transmission type that measures oxygen saturation with a light-emitting sensor and a receiving sensor sandwiching the target blood vessel, and a reflection type that does not sandwich the target blood vessel. The present invention is equipped with a reflection type biological information acquisition device and a temperature sensor in its vicinity. By making the shaft shape conical at the tip and providing a sensor at this conical portion, more reliable measurement can be performed.

[0122] Specifically, the constituent material of the flexible shaft 1 constituting the inserter may be made of a material in which a wiping cover 3 made of an elastic resin such as EVA resin is overcoated or fixedly attached around an axially deformable shaft rod 100A. Alternatively, as the constituent material of the flexible shaft 1, a shaft rod 100A made of a metal material (a rod body with a shape memory alloy or a return spring material interposed) may be used as a core material, and an outer skin material of the adherend may be adhered around the core material. At the base or the shaft head of the shaft portion of the flexible shaft 1, or at the boundary with the shaft head 11, or at an axial part of the adherend or the core material, a freely rotatable mechanism capable of automatically eliminating torsion, or a core material shaft rotation operation mechanism for rotating only the core material around the axis may be provided.

[0123] (High-precision measurement by using the rectum as one of the electrocardiogram electrodes) Taking the insertion location in the body as one of the reference measurement locations, and "comparing" the propagation speeds at one or more other measurement locations: other measurement locations, the degree of pulse pressure can be determined, and blood pressure can be estimated and electrocardiogram information can be obtained. (Biological information acquisition sensor (1)) The biological information acquisition sensor (1) may be an in-body insertion sensor capable of acquiring at least pulse wave information. In the embodiment, a sensor capable of acquiring blood pressure information and SPO2 information with the optical sensor 110S is used.

[0124] (Additional detection unit (26c)) The additional detection unit (26c) is a terminal having an electrode or / and an optical sensor attached to the wearing location on the surface of the body to acquire conductive information, and is wired-connected to 2G. As another embodiment, by also receiving a sensor in the additional detection unit 26, by comparing the SPO2 information at a plurality of measurement locations, blood pressure-related information (such as blood vessel constriction) based on SPO2 can be obtained.

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

[0126] Note that the present invention is not limited to the above embodiments, and various modifications such as integration, separation of the configuration, or increase or decrease in the number of elements, combination with known elements, or replacement of some elements are possible without departing from the gist of the present invention. For example, the main body of the processing unit or the processing device and the display device therein may be configured separately, or the processing by the processing unit, the output by the output unit, and the notification by the notification unit may be simultaneously performed in the management device and output to a preset related terminal in real time. Further, the acquired information of 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 comprises a measurement unit consisting of a rod-shaped flexible shaft that is inserted into a body cavity from a body cavity part such as the rectum or vagina of a target animal for measurement, a processing unit that performs arithmetic processing on the data obtained by the measurement, and an output unit that outputs the arithmetic data by the processing unit, and has the following characteristics.

[0128] The measurement unit includes an optical sensor and a temperature sensor that are arranged adjacent to each other in a specific circumferential direction installation area of the flexible shaft and detect detection values in contact with the inner wall of the body cavity. The shaft head of the flexible shaft excluding the specific circumferential direction is provided with a strip-shaped or hat-shaped wiping cover (3) that contacts and wipes the inner wall of the body cavity.

[0129] The installation area provided with each sensor is composed of one flat circular installation area (horizontally long or vertically long). The wiping cover (3) is composed of a raised brush or a wiping cloth and has a window portion 3H in a shape along the flat circular installation area. While wiping with a raised brush or a wiping cloth around the window portion 3H, The optical sensor and the temperature sensor are arranged side by side in the axial direction within the window portion 3H.

[0130] The wiping cover (3) is composed of a hat-shaped or band-shaped circumferential body that is removably circumferentially mounted on the entire circumferential direction of a predetermined axial direction range at the tip of the flexible shaft, and a plurality of wiping covers can be exchanged.

[0131] It is provided with a light-emitting irradiation unit that emits light around the outside of the shaft, and an imaging camera. The tip of the shaft is composed of a transparent or translucent cover, and the light-emitting irradiation unit is built into the cover at the tip of this shaft. Along with the light-emitting irradiation and the imaging of the camera, each sensor of the optical sensor and the temperature sensor detects a measured value and outputs it to the output unit.

[0132] The tip of the shaft is composed of a transparent or translucent cover, and the light-emitting irradiation unit is built into the cover at the tip of this shaft.

[0133] 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, there are provided an injection nozzle for the cleaning liquid and a delivery device for the cleaning liquid communicated through an internal liquid pipe. 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.

Explanation of Signs

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

Claims

1. A biological information acquisition device comprising: a measurement unit made of a rod-shaped flexible shaft that is inserted into a body cavity of a target animal to perform measurement; a processing unit that performs calculation processing on data obtained by the measurement; and an output unit that outputs a signal of the calculation data by the processing unit, the measuring unit includes a sensor group including a plurality of types of sensors positioned close to a specific installation area in a specific circumferential direction of the flexible shaft or in a specific installation area in a head portion of the shaft at the tip thereof, the sensor group contacting a wall of a body cavity into which the flexible shaft is inserted to detect a detection value; A biological information acquisition device characterized in that a wiping cover is provided around the head of the flexible shaft, excluding the specific installation area, for contacting and wiping the wall of the body cavity into which the flexible shaft is inserted.

2. The installation area including each sensor is configured as a single horizontally or vertically elongated flat circular installation area, The wiping cover is made of a napped brush or a wiping cloth, and has a window portion 3H shaped to fit the flat circular installation area. Wipe the area around the window with a nap brush or cleaning cloth, 2. The biological information acquiring device according to claim 1, wherein a plurality of sensors are arranged in an axial direction along a flat circular installation area within the window portion, and detect the body cavity wall surface in contact or non-contact manner.

3. The bioinformation acquisition device of claim 1, wherein the wiping cover is a hat-shaped or band-shaped peripheral attachment that is attached circumferentially in the entire circumferential direction within a predetermined axial range of the tip of the flexible shaft, and the wiping cover can be removed by deforming the peripheral attachment shape of the peripheral attachment.

4. The bioinformation acquisition device of claim 1, characterized in that the shaft head at the tip of the flexible shaft has a light-emitting irradiation unit that emits light to illuminate the surrounding area, and an imaging camera, and the specific installation area of ​​the flexible shaft has a sensor group that combines one of each of optical sensors, temperature sensors, acoustic wave sensors, radio wave sensors, infrared sensors, electromagnetic wave sensors, electrocardiogram electrodes, and image sensors.

5. 5. The bioinformation acquisition device according to claim 4, wherein a shaft head at a tip of the shaft is formed with a transparent or semi-transparent cover, and the light emitting irradiation unit is built inside the cover at the tip of the shaft.

6. a cleaning liquid ejection nozzle built into a tip surface or a side surface of the flexible shaft at a tip side of the installation area; A liquid pipe is arranged inside the flexible shaft along the axial direction of the rod-shaped member; A cleaning liquid delivery device communicated through a liquid pipe, 2. The bioinformation acquisition device of claim 1, characterized in that while the cleaning liquid is being ejected from the ejection nozzle by the ejection of the cleaning liquid, the body cavity wall is wiped with a wiping cover at the front of the installation area, and each sensor of the sensor group acquires a measurement value, and 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 a signal to the output unit as the calculation data.

7. The flexible shaft further includes a notification unit connected to the flexible shaft by wire or wirelessly. The bioinformation acquisition device of claim 1, characterized in that the notification unit receives the calculation data output as a signal by the output unit via a wired or wireless connection, displays the detection value, and notifies the determination result of an abnormal measurement state by notification means using sound, light, or display.

8. The bioinformation acquisition device of claim 1, further comprising an optical sensor having an intermittent measurement function for measuring information on blood flow in tissue within a body cavity wall intermittently or continuously over a predetermined period of time, and wherein the optical sensor stores the intermittent measurement values ​​of the blood flow information together with a time code, thereby determining whether the intermittent measurement values ​​fall within a predetermined threshold range of a certain fluctuation pattern, thereby determining whether waveform disturbances are caused by body movement or changes in posture.

9. The bioinformation acquisition device of claim 1, further comprising a light emitting irradiation unit and a measurement surface formed of a flat or gently curved surface in a specific circumferential direction of the flexible shaft, the measurement surface including a reflective pulse oximeter and a temperature sensor arranged in the axial direction and targeting blood flow components in the inner wall of the body cavity.

10. 2. The biometric information acquisition device according to claim 1, characterized in that the head of the shaft is a convex rotating body or an elongated spheroid, and the tip bulge portion incorporating a group of contact-type sensors consisting of optical sensors and temperature sensors, and the shaft portion extending in a rod-like shape are abutted and joined or removably combined by an attachment structure.

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