JP7645563B2 - Biological information measuring device - Google Patents

Description

This relates to a biometric information measuring device that detects the biometric information of individual living organisms, including animals and livestock. In particular, it includes domesticated mammals such as pet dogs and cats as target living organisms.

Conventional near-infrared cerebral oxygen monitors are primarily used for monitoring during surgery. Specifically, a sensor is attached to the skin of the head, and tissue oxygen saturation is non-invasively (percutaneously) evaluated at a location approximately 2-3 cm directly below the sensor. The guidelines for using near-infrared cerebral oxygen monitors in cardiovascular anesthesia state that "cerebral oxygen monitors using near-infrared spectroscopy (near-infrared cerebral oxygen monitors) are frequently used in cardiovascular surgery because they can continuously and non-invasively predict the balance of oxygen supply and demand in the brain. It is believed that early detection and treatment of cerebral hypoperfusion can reduce preventable brain damage."

However, the normal value for brain tissue oxygen saturation in healthy adults is said to be 58% to 82%, or 70% ± 10%, and the normal range for absolute values is wide. The reason why the normal range for absolute values is set wide is because of the influence of individual differences in the person being measured. Specifically, there are individual differences in the thickness of the skull, the amount of bodily fluids such as cerebrospinal fluid, and subcutaneous blood flow, and it is said that measurement errors occur depending on the person being measured.

For example, in a conventional near-infrared cerebral oxygen monitor that measures by attaching a sensor to the skin of the head, as described in Patent Document 1, the measured value is evaluated as a relative value, and is evaluated based on the percentage by which the value for the same patient under the same conditions has decreased or increased over time during surgery. Therefore, it was difficult to evaluate the measured value as an absolute value, or to determine whether the measured value was normal or abnormal.

In addition, due to the influence of individual differences in the person being measured, if the sensor is attached in a slightly different position from the previous time, if the sensor is attached in a different way, if the patient's posture is different, or if the measurement value varies depending on the person measuring, there are issues with measurement errors occurring and the measurements being difficult to reproducible.

Patent No. 6452896

The present invention aims to provide a biometric information measuring device that can evaluate the measured value itself as an absolute value, or determine whether the measured value is normal or abnormal, and that can ensure reproducibility of the measured value without causing fluctuation in the measured value depending on the measurement conditions, the subject being measured, or the person measuring it.

The following measures have been taken to solve the above problems. Note that the numbers or character strings of numbers and letters following the names of the following components are symbols shown for the convenience of understanding the components in the drawings, and are not intended to have any meaning or limitation in themselves.

[1] (Elimination of false positives by determining rectal adhesion state)
A measuring device comprising: a measuring unit (pulse oximeter) having a rod-shaped flexible shaft 1 that is inserted into the rectum of a subject animal for measurement; a processing unit that performs calculation processing on data obtained by measurement by the measuring unit; and an output unit that outputs a signal of the calculation data by the processing unit,
The measurement unit includes a contact-type sensor group including an optical sensor (reflective pulse oximeter) 110S and a temperature sensor 110T, which are arranged in a specific circumferential direction of the flexible shaft and are adapted to contact and detect blood flow components on the inner wall of the rectum and target the blood flow components on the inner wall of the rectum, and which are arranged in the axial direction so as to face a common specific circumferential direction (a specific phase direction around the axis when viewed in the axial direction);
The processing unit determines whether or not there is an abnormal measurement state based on the detection values of each sensor (whether a pulse peak can be identified, whether the peak value is within a predetermined threshold range, whether there is a constant rhythm that should be synchronized with the electrocardiogram waveform, and whether the detection value of the temperature sensor is a normal value), and outputs this determination result together with the detection values of each sensor as the calculation data, as a signal to the output unit, which then outputs it in the form of sound, light, image or text or color display or change, vibration, etc.

The flexible shaft and the output unit may be physically connected by an integral or coupled structure, or the flexible shaft and the output unit may be in a non-connected state and receive the detection value or output signal by a wired or wireless connection. In Examples 1 and 2 described below, the flexible shaft and the output unit having a display unit are integrally configured, and the housing of the display unit serves as an operating handle during insertion. On the other hand, in Example 3 (Figs. 10 and 11) described below, the flexible shaft and the output unit having a display unit are connected by a cord connector structure 28c via a cord-like transmission line 28.

In addition, by arranging each sensor in the same direction in the axial direction, it is possible to measure the temperature and blood flow of a continuous surface in the insertion direction of the intestinal wall, and by ensuring the correlation of the measurement values of each sensor, it is possible to ensure the accuracy of identifying abnormal measurement conditions.

[2] Further comprising an alarm unit (as an integral structure or a separate structure) connected to the flexible shaft by wire or wirelessly;
The notification unit receives the calculated data output as a signal by the output unit via a wired or wireless connection, displays the sensor detection value, and notifies the result of the abnormal measurement state determination by notification means using sound, light, or display.

An abnormal measurement state is notified by the notification (display or sound) unit that notifies (to a separate terminal notification device/integrated display). By notifying an abnormal measurement state by sound, light, or display, erroneous data recognition can be prevented and the flexible shaft insertion operator can be prompted to adjust the measurement state.

In the embodiment disclosed in Figures 1 to 6, the flexible shaft is provided with an alarm unit having an integrated display and operation unit. Alternatively, the flexible shaft may have a built-in processing unit, output unit, and data transmission unit, and may be provided with an alarm unit having a built-in corresponding receiving unit, and a display unit. Alternatively, the flexible shaft may have a built-in data transmission unit, and may have a processing unit, output unit, and alarm unit separate from the shaft.

(Contact type sensors)
On the side of the flexible shaft, a group of contact-type sensors are arranged in the axial direction so that they face the same circumferential direction, i.e., a specific lateral direction. In this embodiment, the sensors are a combination of an optical sensor 110S and a temperature sensor 110S, but a pressure sensor may also be combined. Based on the measurement values of each sensor, which are thought to be correlated, a comprehensive judgment is made as to whether or not there is an abnormal measurement state.

[3] (Measurement and Evaluation) *SPO2 sensor ← SPO2
The device has an intermittent measurement function that measures the oxygen saturation of the microvessels or tissue oxygen saturation of the rectal tissue intermittently or continuously over a specified period of time, and by storing the measurement value together with a time code, it is possible to determine whether the detected SPO2 value falls within a specified threshold range of a certain fluctuation pattern and to determine whether there is any disturbance in the waveform due to body movement or changes in posture.

(Continuous and intermittent measurement function)
Here, the intermittent measurement function is a functional element that measures oxygen saturation or tissue oxygen saturation intermittently or continuously for a predetermined period of time, and corresponds to an optical sensor (e.g., a reflective pulse oxisensor) 110S that targets the blood flow components on the inner wall of the rectum, as in the embodiment described below. In the embodiment described below, a reflective optical sensor that is the optical sensor 110S that measures the oxygen saturation in the blood is provided on the measurement surface near the tip of the flexible shaft 1, and this reflective optical sensor continuously measures the oxygen saturation of the blood flow on the inner wall of the rectum for a predetermined period of time.

However, it also includes a function that uses an optical sensor to measure tissue oxygen saturation (including venous blood) in the artery at the measurement location. The "functional element that measures oxygen saturation or tissue oxygen saturation" includes both a function that estimates and calculates tissue oxygen saturation at a specific location of the target living body based on oxygen saturation measurement, and a function that estimates and calculates oxygen saturation at a specific location of the target living body based on tissue oxygen saturation measurement. In the embodiment, the oxygen saturation at the measurement location (rectum) is output, but it may also be a function that estimates and calculates tissue oxygen saturation of the intestine or brain and outputs it, or a function that switches between these. In this case, it can be said to be a continuous intermittent measurement function that measures tissue oxygen saturation intermittently or continuously for a specific period of time based on the oxygen saturation of the microvessels in the rectal tissue.

(Composite discrimination by simultaneous measurement of TMP and SPO2)
Contact temperature measurement determines whether the temperature is constant. The appropriateness of SPO2 measurement can be determined by whether the rectal temperature is constant, and other diseases and abnormalities in lung function can also be detected. Cardiac function can also be evaluated by fluctuations in HR and TMP only. For example, abnormalities in cardiac function and lung function can be detected by whether a pulsation peak can be identified, whether the peak value is within a predetermined threshold range, and whether the heartbeat has a constant rhythm.

[4] (Measurement surface 11F)
The flexible shaft is characterized in that a flat measurement surface 11F formed of a plane or a gently curved surface in a specific circumferential direction has an optical sensor 110S and a temperature sensor 110T arranged axially on the flat measurement surface 11F, which target blood flow components in the inner wall of the rectum.

The measurement surface 11F, which is formed as a flat or gently curved surface, can be brought into stable contact with the intestinal wall. In addition, by arranging them in the axial direction on the measurement surface 11F, the SPO2 and temperature of the contact surface can be accurately measured. Note that in the embodiment, the reference numeral 110T denotes a temperature sensor and 110S denotes an optical sensor, but there are also possible examples of arrangement in which the order is reversed, or in which they are arranged perpendicular to the axial direction, so-called side-by-side arrangement.

[5] (Limit shaft cross-sectional shape and attachments)
The device is characterized in that the tip bulge 11 has a convex rotating body or an elongated spheroidal head 111 at its tip and has a contact-type sensor group consisting of an optical sensor 110S and a temperature sensor 110T built into its side, and the shaft portion 12 extending like a rod is abutted and joined by attachment structures 121, 122 or removably combined with the tip bulge 11.
The tip of the shaft 12 is provided with a bulging tip 11, and the tip of the bulging tip 11 has a bullet-shaped head, allowing for smooth insertion without damaging the rectal wall. The bulging tip 11 also promotes intestinal contraction, improving adhesion to the intestinal wall.

In addition to the above, it can be used in the following ways:

[6] Measurement result recording program Testing application (sharing measurement results with owners) (Figs. 6 and 7)
The system allows owner information (pet's individual data and characteristics) to be entered from the owner app, measurement data and test records to be entered from the medical app, and each piece of information to be accessed from each app via the server. It is characterized by the ability to display data trends and time-recorded statistics (average values for the animal, normal data behavior), and search and output by linking with electronic medical records. Test data can be shared. (It can also be used as monitoring information. It is also possible to create a system that links data with other measuring devices (ultrasound imaging devices, blood testing devices) and photographs.)

[7] System linked with attribute data (Fig. 6) By inputting personal data PD such as attribute data and individual data of the target animal, a threshold value for determining the range of normal values can be automatically set. In addition, by inputting medical data MD such as the target animal's past or present medical history, chronic illnesses, injury and surgery history, and castration data, a threshold value for determining the range of normal values can be automatically set. In the system shown in Fig. 6, each of these data is stored in the server 4 together with the accumulated data of the acquired data, and the data is comprehensively managed and displayed in the processing unit (5, 28) of each terminal.

[8] (Hospitalization and visit information)
The system further includes a step of setting, as medical data, hospitalization information or visit information to a hospital or facility for a predetermined symptom of the subject individual,
Data may be output separately for data at the time of admission or visit to the hospital and data at home, and alerts may be detected by comparing the values with those of other attribute groups (Figure 6).

(Comparison with statistical data)
Only normal measurement data is recorded.
The device used for temporary testing (pulse oximeter) is inserted into the intestine to store previous measurement data (or data from animals of the same species), and is used in conjunction with a statistical processing system for the stored data.
At least the pulse rate and rectal temperature may be measured using an intraenteral insertion examination device (pulse oximeter) and compared with statistical data for use in the calculation process of an estimated rectal temperature or for checking an error in the pulse rate.

By providing a notification means for alerting the measurement status of a specific individual, the above-mentioned means make it possible to evaluate the measured value as an absolute value, or to determine whether the measured value is normal or abnormal. It is also possible to provide a biometric information measuring device that is less likely to fluctuate depending on the measurement conditions, the subject being measured, or the person measuring, and ensures the reproducibility of the measured value.

1A is a front view, FIG. 1B is a rear view, FIG. 1C is a bottom view, FIG. 1D is a left side view, and FIG. 1E is a right side view of a biological information measuring device according to a first embodiment of the present invention. FIG. 2 is a cutaway perspective view of the biological information measuring device according to the first embodiment taken along the line A-A of the FIG. FIG. 2 is an exploded front view of the configuration of FIG. 1 with a cover and an attachment removed; B-B cross section (right) and CC cross section (left) of Figure 3 1 shows an example of a side use state and an example of a flat use state of the biological information measuring device of the first embodiment. FIG. 13 is a diagram illustrating the configuration of a biological information measuring device and a measuring system including the biological information measuring device according to a second embodiment of the present invention; Display examples and data configuration examples of the biological information measuring device of the embodiment 1. Continuous display example of judgment data by the biological information measuring device of the embodiment (normal state, abnormal state) Example of statistical display of judgment data (also displays enlarged abnormality status) FIG. 13A is a perspective view of a biological information measuring device according to a third embodiment, and FIG. 13B is an explanatory diagram of a usage state of the biological information measuring device according to the third embodiment. FIG. 13 is a front view of a biological information measuring device and a terminal according to a third embodiment.

Below, examples of how to implement the present invention are described with reference to the figures shown as examples.

(Device configuration)
The bioinformation measuring device of the present invention is a measuring device equipped with a measuring unit (pulse oximeter) consisting of a rod-shaped flexible shaft 1 which is inserted into the rectum of a target animal to perform measurement, a processing unit 2 which performs calculation processing on the data obtained by measurement by the measuring unit, and an output unit (built into the processing unit 2) which outputs a signal based on the calculation data by the processing unit (Figure 1).

(Measurement unit (pulse oximeter consisting of flexible shaft 1))
The measuring section is made of a rod-shaped flexible shaft 1 that can be inserted into the rectum of a target animal. In the same specific circumferential direction of the flexible shaft, an optical sensor (reflective pulse oximeter) 110S that detects the inner wall of the rectum by contact (targeting the blood flow components in the inner wall of the rectum) and a temperature sensor 110T are arranged in the axial direction so as to face the common specific circumferential direction (FIG. 1a). Here, the common specific circumferential direction refers to a specific phase direction around the axis (the direction of the lead line of reference numeral 31 in FIG. 1d) in the axial view as shown in FIG. 1d.

(Flexible Shaft 1)
The flexible shaft 1 has a convex rotating body or an elongated spheroidal head 111 at its tip, and is integrally formed with a tip bulge 11 with a contact-type sensor group built into the side and a rod-like extending shaft portion 12, which are connected in the axial direction (Figs. 1, 2, 5, 6, etc.). An elastically deformable shaft rod 100A is built into a portion of the central section of the flexible shaft.

The tip of the elastically deformable flexible shaft 12 is provided with a bulging tip 11 at its axial end, giving it a rod-like shape with a bulging tip, and the tip of the bulging tip 11 has a warhead-shaped head. As shown by hatching in Figure 2, the bulging tip has a partially circular axial cross-sectional shape, specifically, an approximately two-thirds circle with the upper one-third of a given diameter cut perpendicular to the diameter. A shaft rod 100A is built into the center of the circular cross-sectional shape, and transmission lines for measurement signals from each sensor in the measurement unit are fixed along the shaft rod 100A, and each sensor is connected by wire to the processing unit. The tip of the bulging tip is a convex rotating body or oval that narrows toward the tip, for example, a red round nose warhead-shaped head shape (Figure 1, etc.).

(Attachment structure)
In the embodiment shown in Figure 3, a corresponding attachment structure 121 and an attachment structure 122 are provided at the base of the tip swelling portion 11 and the tip of the shaft portion 12, respectively, and the end faces of one attachment structure 121 and the other attachment structure 122 are brought into contact with each other, and the attachment structures are rotated in one direction so that the locking projection 121C of one attachment structure 121 and the locking groove 122D of the other attachment structure 122 are locked, thereby the attachment structures are joined together and in a combined state. This combined state can be removed by rotating them relative to each other in a specific direction (Figure 3).

(Cover part 3)
In the embodiment, a cover part 3 is further provided which integrally covers the entire attachment structure up to a part of the processing part 2 connected to the other attachment structure 122. The cover part 3 is made of an elastically deformable resin molded body such as EVA resin, which is integrally molded by connecting a cylinder 31 into which the shaft part 12 can be inserted and a frame 32 which can be fitted into the tip part of the rectangular parallelepiped of the processing part 2.

(Contact type sensors)
The tip bulge 11 of the flexible shaft is provided with a flat measurement surface 11F formed of a flat or gently curved surface in a specific circumferential direction and with a rounded edging around the surface, and a "contact type sensor group" consisting of an optical sensor 110S and a temperature sensor 110T targeting the blood flow components of the inner wall of the rectum is arranged in the axial direction on this flat measurement surface 11F so as to face the same circumferential direction, i.e., a specific lateral direction. In the embodiment, the sensor is composed of a combination of an optical sensor 110S and a temperature sensor 110S, but a pressure sensor may also be combined. Based on the measured values of each sensor that are considered to be correlated, a comprehensive judgment is made as to whether or not there is an abnormal measurement state.

The measurement surface 11F, which is formed from a flat or gently curved surface, and the rounded edging around it allow the measurement surface to be in stable contact with the intestinal wall. In addition, by arranging the electrodes in the axial direction on the measurement surface 11F, the SPO2 temperature of the contact surface can be accurately measured.

In the embodiment, reference numeral 110T denotes a thermometer and 110S denotes an optical sensor, but there are also possible examples in which the order is reversed, or in which they are arranged side-by-side, perpendicular to the axial direction.

(Optical sensor 110S)
The optical sensor 110S can be either a reflective or transmissive optical sensor. This utilizes the difference in light transmittance/reflectance to receive light emitted at multiple wavelengths with a light receiving sensor, and measures the light intensity and wavelength of the reflected light/transmitted light to compare and measure the light transmittance of the reflected signals of the arterial and venous blood flows in the inner wall of the rectum that are in contact with the sensor. In this embodiment, a reflective pulse oximeter is used, and the optical sensor determines whether the blood is arterial or venous, and an electrocardiogram waveform is obtained based on the principle of measuring the oxygen saturation of the arterial blood.

(Detection of abnormal measurement state)
Detection of an abnormal measurement state (determining whether or not an abnormal state exists) means determining whether there is an abnormality in the state of adhesion to the rectum (whether optical interference from stool, etc., or the degree of adhesion to the intestinal wall is within the range of normal measurement) or an abnormality in measurement due to sudden body movement (whether measurement is impossible due to body movement).

The detected value (whether the pulse peak can be identified (value cannot be obtained), whether the peak value is within a specified threshold range, whether it is a constant rhythm that should be synchronized with the heartbeat (fluctuations in value per unit of time due to sudden increases and decreases)) is determined. Examples include undercounting the pulse rate due to poor contact (low value making it impossible to measure), abnormal values due to excessive body movement, and discontinuity in measured values due to time changes (sudden abnormal values in the heart rate due to double counting). For example, a change (fluctuation) per unit of time around one second that is more than twice the normal amount is a clearly abnormal change per unit of time.

The temperature sensor 110T uses a thermometer to measure the temperature of the body tissue in contact with the sensor, and determines the stability of the measurement based on whether the thermometer measurement value is within the normal range and the amount of change per unit time. For example, a clearly abnormal measurement value for the target animal, or an abnormal change per unit time of around 1 second can be input and set in advance, and if this set value is exceeded, it can be determined that an abnormal measurement state exists.

(Sudden body movement)
The causes of abnormal measurement state include unexpected body movement and the presence of foreign matter. The animal may make unexpected body movements unintended by the measurer due to the need for restraint, differences in posture, improper fixation by the tail, etc. In this state, proper SPO2 measurement cannot be performed. In response to this, in the present invention, a flat measurement surface 11F for contact measurement consisting of a substantially flat surface is formed in a specific circumferential direction of the tip swelling portion, and the processing unit main body 2 is operated so that this flat measurement surface 11F is pressed against the rectal wall, and measurement is performed by bringing the bulged flat measurement surface 11F of the tip swelling portion into close contact with the intestinal wall (FIG. 5). This makes it easier to maintain a normal measurement state even if there is unexpected body movement. In addition, by measuring in the rectum, measurement errors due to light interference, pigmentation, and the influence of body hair do not occur in the first place.

The processing unit of the present invention has a step of analyzing whether the electrocardiogram waveform obtained by the reflective pulse oxisensor (optical sensor 110S) built into the flexible shaft repeats regular time fluctuations within a predetermined distortion range to determine whether the measurement is normal. This utilizes the principle that, unless there is arrhythmia, the electrocardiogram waveform will be synchronized in a normal measurement state without body movement or fecal interference.

(Processing section)
The processing unit is a part that performs arithmetic processing of data obtained by the measurement of the measuring unit, and the processing unit in the embodiment is built into the processing unit body 2 in a thin rectangular parallelepiped shape, and this processing unit body 2 is configured integrally with the flexible shaft 1. The arithmetic processing is characterized in that erroneous detection is eliminated by determining the rectal adhesion state, that is, the presence or absence of an abnormal measurement state is determined by the detection value of each sensor. In the embodiment, an output unit is further built into the processing unit body 2 in a thin rectangular parallelepiped shape. The processing component body 2 in the embodiment has a processing unit and an output unit built in, and is equipped with a display unit 21 that displays processed data on a liquid crystal display on the front, an acquisition unit 23 for authentication data, and a speaker (not shown) that notifies of an abnormal state. A switch 25 and two buttons 24 that serve as 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 built into the back.

The presence or absence of an abnormal measurement state is determined, for example, by whether a pulsation peak can be identified, whether the peak value is within a predetermined threshold range, whether there is a constant rhythm that should be synchronized with the electrocardiogram waveform, and whether the detected value of the temperature sensor is normal.

More specifically, it has an intermittent measurement function that measures the tissue oxygen saturation of the microvessels in the rectal tissue intermittently or continuously over a specified period of time, and by storing the measurement value together with a time code, it is possible to determine whether the SPO2 sensor detection value falls within a specified threshold range of a certain fluctuation pattern and to determine whether there is any disturbance in the waveform due to body movement or changes in posture.

(Synchrony-Based Estimation Step)
The determination of an abnormal measurement state may include a step of estimating a normal measurement state based on the synchronization of the changes in the SPO2 and temperature values. Generally, there is a correlation between the changes in the SPO2 and temperature values. By determining the correlation between the changes in the SPO2 and temperature values, it is possible to determine whether the measurement state is normal. In addition, it is possible to determine whether the measurement state is abnormal based on changes in heart rate that are not linked to changes in body temperature. That is, body temperature changes are generally caused by inflammation, and the heart rate should also increase in conjunction with the changes, but if they are not linked, there is a risk of an abnormality in the measurement state. On the other hand, if only either the heart rate (circulatory function) or the SPO2 (pulmonary function) is abnormal even though the body temperature is normal, it can be determined that there is a high possibility that the measurement state is normal.

In a system equipped with a transmitting unit and a server with an automatic data storage function as shown in FIG. 6, data 21P1, 21P2 at each time can be stored in chronological order in a data set state as data sets DSU1, DSU2, ... consisting of continuous data, as shown in FIG. 7. At this time, the time code P2 containing the abnormal measurement discrimination data 21P2 is automatically recorded, and this time code is stored in the data structure part of the chronological data set as error data DSE excluded from the data set. The data set in a normal measurement state can be played back and displayed as a short video, or only the data set in a normal measurement state can be extracted and played back continuously.

In addition, data on the normal range for the target animal is input in advance, and if two or more of SPO2, heart rate, and temperature are clearly deviating from the normal values, it can be determined that there is an abnormality in the animal's restraint state or the insertion state of the measuring device. This data on the normal range can be converted data based on input of the target animal's personal data PD or input of treatment data MD at the medical institution (Figure 6).

(Composite discrimination by simultaneous measurement of TMP and SPO2)
Contact temperature measurement determines whether the temperature is constant. Whether the rectal temperature is constant can determine the appropriateness of the SPO2 measurement. It can also detect the presence or absence of other diseases and abnormalities in lung function.

Cardiac function can also be evaluated based on fluctuations in HR and TMP alone. For example, abnormalities in cardiac or pulmonary function can be detected based on whether or not a pulsation peak can be identified, whether or not the peak value is within a predetermined threshold range, and whether or not the heartbeat has a regular rhythm.

(Estimation of tissue oxygen saturation)
As a future possibility of utilizing the technology, it is also possible to estimate and calculate the local mixed blood oxygen saturation and/or tissue oxygen saturation of the brain based on the measurement evaluation of the continuous and intermittent measurement function. In addition, in synchronization with the detected pulse, the change in the oxygen supply and demand balance of the local tissue, the local perfusion state, metabolism, and blood flow state are evaluated, and the evaluation results are displayed on the display unit.

The tissue oxygen saturation (StO2, rSO2) of the present invention is measured not on the surface of a peripheral area, but on mixed blood including arterial blood components, venous blood components, and capillary blood components in internal organs, making it possible to estimate and calculate local mixed blood oxygen saturation and/or tissue oxygen saturation in the rectum.

(Output section)
The output unit outputs the discrimination result by the processing unit together with the sensor detection value as the calculation data to the output unit (by displaying or changing sound, light, image, character or color, vibration, etc.). The output unit of the embodiment includes a transmission unit 27 built into the thin rectangular processing unit body 2 integrally formed with the flexible shaft 1, and a display unit 21 as an alarm unit provided on the front side of the processing unit body 2. The display unit 21 notifies the discrimination result by lighting up the display in a normal state or flashing the display in an abnormal state. In the display example shown in Figures 1, 3, 6, 7, etc., the display unit 21 displays a discrimination result display 201 consisting of a heart-shaped mark, a time code 202 of the measurement date and time, a measured value 203 of the body temperature TEP, a measured value 204 of the heart rate HR, and a measured value 205 of the SPO2 side by side. The alarm unit 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 via a wired or wireless connection, and outputs and displays the sensor detection value from the display unit or sound unit of the output unit.

(Display unit 21)
The display unit 21 displays the measured values of body temperature and heart rate as numerical values, and continuously displays each waveform based on time change (FIGS. 8 and 9). When there is a data-unacquired portion (204GE) or a waveform discontinuity portion (205GE) in each waveform, the section ER in that time period 202 is determined to be an abnormal measurement state, and an error display 207 consisting of the word "Error" indicating the abnormal measurement determination result is displayed by lighting or flashing (FIG. 8b).

The measurement status determination result is output as data to the output section. On the output screen, as shown in FIG. 9, the text display may be switched between normal measurement status "M" and abnormal measurement status "E". Also, as shown in FIG. 7, the inside of a heart-shaped mark may be switched between illuminated and unilluminated. In addition, when displaying each waveform, as shown in FIG. 9, the data details of a specified section MSR of a shortened display MR of a past waveform may be displayed in parallel as an expanded display SR with the horizontal axis expanded.

When the heart rate (up and down fluctuations in SPO2) shows regularity in time-dependent changes at a constant rhythm as shown in Figure 8a, and the amount of change over time or the acceleration of change is within the threshold, a normal display is made (Figure 8a, DS1, DS2 in Figure 9). However, when the amount of change in body temperature is abnormal, or there is an abnormal rhythm due to arrhythmia (amount of change over time outside the threshold), an abnormality judgment display is made (DSE in Figure 9).

1 to 6, a notification unit is provided that includes a display unit and operation unit that is integrated with the flexible shaft. Alternatively, a processing unit, an output unit, and a data transmission unit may be built into the flexible shaft, and the notification unit may include a corresponding receiving unit and a display unit. Alternatively, a data transmission unit may be built into the flexible shaft, and the processing unit, output unit, and notification unit may be provided separately from the shaft.

(System Configuration)
The measurement system of the present invention shown in Fig. 6 is a system including the biological information measurement device of Example 2, a server 4 for storing transmitted and received data, a processing device (2, 28, 5) for processing the data of the server, and an output device (21, 281, 51, 61) for outputting the processed contents (Fig. 6). A terminal 61 owned by the owner of the living animal, i.e., a patient, and a terminal 5 owned by a medical institution or a treating doctor, i.e., a medical worker, are data-linked via the server.

(Emergency assessment and notification)
In such a measurement system, in a normal measurement state, it is possible to know a change in the physical state that requires emergency treatment. When a result of the emergency judgment is obtained, it is preferable to notify the user by sound and/or flashing in the notification unit, and to perform data linkage and automatic linkage of the started application, such as outputting an emergency signal to a display unit or processing unit that can link data, such as the user terminal or doctor terminal shown in FIG. 6.

(Measuring device 100 (pulse oximeter) of Example 2)
6, the measuring device of Example 2 has an elastically deformable truncated cone-shaped flexible part 12B fixed to the side of the processing unit main body 2, and a tip part formed integrally with a rod-shaped shaft part 12 and a tip bulge 11 fixed to the tip of the flexible part 12B. A transparent tubular part 110 is removably incorporated in a predetermined axial section of the warhead-shaped head of the tip bulge 11, and one side of this tubular part 110 is molded into a flat measurement surface 11F, and a temperature sensor 110T and an optical sensor 110S are housed inside the tubular part 110, side by side in the vicinity of the circumferential direction.

Specifically, a flat measurement surface 11F is formed in a predetermined circumferential direction of the tip bulge 11, and a partial area of this flat measurement surface 11F is assembled and configured by a transparent tubular part 110, and a group of sensors (temperature sensor 110T and optical sensor 110S) whose measurement direction is the normal direction of the measurement surface 11F are housed side-by-side and close to each other inside the transparent part of the measurement surface 11F formed by the tubular part 110. After measurement, the tubular part 110 can be removed or replaced with another part for further use.

The measuring device of Example 2 is provided with a bioinformation reading sensor 23 on the front side of the processing unit main body 2, which is formed in the shape of a rectangular plate, and can read the identification information or microchip information of the target animal. The processing unit main body 2 also has a wireless transmitter 27 embedded therein, and the acquired data is transmitted in real time to the output terminal 28 set up for data linkage, and the acquired data is processed and displayed in a reproducible manner on the display unit 281 of the output terminal 28. The processed data is, for example, the continuous display processed data shown in FIG. 8 or the statistical display processed data shown in FIG. 9, which is edited and recorded by the processing terminal and also stored in the server 4, and is displayed in a reproducible manner on the display unit of each terminal.

(Measuring device of Example 3)
In the measuring device of the third embodiment shown in Figures 10 and 11, an elastically deformable truncated cone-shaped flexible part 12B is fixed to the side of a thin box-shaped processing unit main body 2, and a tip part in which a rod-shaped shaft part 12 and a tip swelling part 11 are integrally molded is fixed to the tip of the flexible part 12B. A transmission line 28 is connected to the base side of the processing unit main body, and a terminal 30, which is an output part and an operation part, is connected by a connector structure 28C at the tip of the transmission line 28. The terminal 30 processes the output data from the processing unit main body 2 using application software, and displays the measurement contents such as a normal measurement status display 301 (illuminated or blinking pattern display) and 305 (colored or blinking character display), SPO2 value 302, heart rate 304, body temperature 303, and a time chart graph display 306 (time chart graph of heart rate) and 307 (time chart scale) on the display screen 31, or emits an alert sound or vibration.

(Compared to conventional products)
Generally, medical equipment that measures brain tissue oxygen saturation is called a near-infrared brain oxygen monitor, and is clearly distinguished from conventional pulse oximeters that measure only percutaneous arterial blood oxygen saturation. The tissue oxygen saturation or local mixed blood oxygen saturation refers to the oxygen saturation of microvessels (arterioles, venules, capillaries). In addition, most of the percutaneous arterial blood oxygen saturation (SPO2) measured by conventional pulse oximeters targets only the arterial blood of peripheral sites (fingertips, ears, tongue, nose, etc.). However, in conventional oxygen saturation and tissue oxygen saturation measurements, there is a possibility that measurement errors will occur depending on the measurement environment due to the influence of light interference from fluorescent lights, etc. In addition, measurement errors may occur depending on the method and position of attaching the sensor to the skin, which may affect the reproducibility of the measured value.

In contrast to the conventional products, the present invention proposes a new bioinformation measuring device that addresses the above-mentioned problems with conventional measurements. This bioinformation measuring device, a pulse oximeter, measures oxygen saturation (SPO2) and tissue oxygen saturation (also known as STO2 or RSO2), or so-called rectal measurement, by inserting a sensor directly into the rectum or colon, which are organs that are relatively close to the body surface and can be reached with minimal invasiveness, to make surface contact with the rectum or colon.

(Advantages of rectal measurement)
The continuous and intermittent function of measuring tissue oxygen saturation (so-called STO2 or RSO2) by directly contacting a sensor with an organ (e.g., esophagus, stomach, rectum, colon, etc.) can reduce the influence of individual differences due to the bones and body fluids of the subject, compared to measuring StO2 by attaching a sensor to the body surface, and even tissue oxygen saturation can be evaluated as an absolute value. In addition, compared to StO2 and SPO2, StO2' and SPO2' are measured by inserting a sensor into the measurement section, so measurement errors due to the attachment and attachment position of the sensor by the measurer are less likely to occur, and the reproducibility of the measured value may be increased. The reproducibility is affected by the fact that the sensor may become dirty due to contents or feces in the organ, causing measurement errors. At the same time, since the position where the sensor is directly contacted with the organ is inside the body, measurement errors due to the measurement environment such as optical interference can also be eliminated.

(Specific example of blood flow target and evaluation calculation process of the present invention)
Compared to conventional products, the tissue oxygen saturation (so-called StO2, RSO2) measured by this invention targets mixed blood including venous blood components and capillary components in addition to arterial blood components, and the purpose is to evaluate changes in the oxygen supply and demand balance of local tissues, local perfusion status, metabolism, and blood flow status by measuring the oxygen saturation of some tissues.

(Comparison with other local oxygen saturation ( _SPO2 ))
The present invention can also estimate whole body oxygen saturation (SPO2) from local oxygen saturation (SPO2') by combining with a measuring device for a site other than the rectum (such as a fingertip or head body surface measurement). For example, by simultaneously measuring SPO2 measurements (SPO2') on the tongue surface and SPO2 measurements (SPO2'') on the rectum, it is possible to compare the differences in the values and behavior of the values, or to use the comparison value as a new parameter: oxygen saturation comparison value.

In addition to comparing the StO2' and SPO2' values, another method is to measure SPO2' and SPO2 simultaneously and compare the values with the arterial waveform. If SPO2' is lower than SPO2, it is possible to infer bleeding, ischemia, or reduced blood flow in the arterial blood of the measurement area (e.g. esophagus, stomach, rectum, colon, etc.). By comparing the StO2' and SPO2' values, and comparing the SPO2' and SPO2 values with the arterial waveform, it is possible to infer abnormalities in the measurement area or surrounding organs and use this information to determine whether or not to perform a CT scan or ultrasound examination.

<Basic Features of the Invention>
The following are extracted as basic features of the present invention.
(1) A measuring device (pulse oximeter) having a flexible shaft that is inserted into the rectum of a target animal for measurement,
A reflective pulse oximeter and temperature sensor that target the blood flow components on the inner wall of the rectum are closely arranged on the flat side of the flexible shaft (Figure 1). The shape is suitable for rectal insertion and is less susceptible to the influence of fecal matter.
(2) Measuring the tissue oxygen saturation of the microvessels in the rectal tissue to evaluate changes in the oxygen supply and demand balance of the local tissue, the local perfusion state, metabolism, and blood flow state, and then estimating and calculating the local mixed blood oxygen saturation and/or tissue oxygen saturation of the brain based on this evaluation.
Since it calculates tissue oxygen saturation rather than simple oxygen saturation, it can measure even in low blood pressure or when arterial pulsation is weak or absent. In addition, since it estimates and calculates oxygen saturation in brain tissue from the measurement value of rectal tissue, it is more reliable than conventional peripheral site measurements.
(3) The oxygen saturation or tissue oxygen saturation (StO2, rSO2) of the present invention is measured not on the surface of a peripheral site but on a mixed blood including arterial blood components, venous blood components, and capillary blood components in internal organs. Since tissue oxygen saturation is a measurement value including venule and capillary blood components, it can also detect venous and capillary abnormalities such as microbleeding in tissues. In addition, since a measurement value is obtained for each pulse, measurement information for a healthy individual of the target organism can be obtained by processing to correct the variation.

<Effects of the present invention>
The present invention provides a pulse oximeter or measurement system that can avoid erroneous recognition of data due to an abnormality in the measurement state by providing a notification means for alerting the measurement state of a specific individual. Specifically, the following advantages of the pulse oximeter can be utilized.
- Oxygen saturation is difficult to measure when blood pressure is low or the arterial pulsation is weak (or absent), but tissue oxygen saturation can be measured.
- Because tissue oxygen saturation is a measurement that includes venular and capillary components, it is possible to measure microbleeding in tissues that is difficult to reflect by oxygen saturation.
- A shape that detects rectal pressure and is easy to place in the rectum (the value is stable and the animal is unlikely to resist it, making it suitable for testing (examination) active animals). In particular, the tip of the relatively thin elastic shaft is flattened (balloon-shaped), making it ideal for monitoring the depth of anesthesia. It can also detect the occurrence of excessive pain and predict accidents caused by bodily movement.

<Use for anorectal pressure testing>
The pulse oximeter of the present invention may be used to detect painful conditions or evaluate anorectal manometry tests performed to diagnose fecal incontinence.

(Hospitalization and visit information)
As a processing method of a measurement system equipped with the measurement device of the present invention, a step of setting hospitalization information or visit information to a hospital or facility for a specified symptom of a target individual is further included, and data at the time of hospitalization or visit to the hospital and data at home can be output separately.

(Group recording of pre- and post-operative data)
The method further comprises a step of storing treatment information for a predetermined symptom of the subject individual, and group-recording resting data of the subject individual during a pre-operative or post-operative period as attribute data of the symptom.
For example, by combining the attribute groups "medical history,""surgicalhistory,""before and after surgery," and "before and after contraception," it is possible to determine the status of postoperative progression.

(Alert output)
It determines whether the transmitted data exceeds preset upper, lower, and average values, and if it detects that the values have been exceeded, it outputs an alert.

In this system, it is preferable to perform individual machine identification based on the personal data PD when acquiring data or storing data on the server.

It is also preferable to have a matching unit that matches the differences in data accumulation or measurement with individual identification using the microchip number. For example, the processing unit main body 2 may be provided with a reading unit 23 that acquires and authenticates the microchip data of a living animal, and a matching unit that matches the read data, and when data is stored in the server 4 or output processing is performed by the output processing unit, the personal data PD and treatment data MD are linked, and a matching step of matching the individual identification information of the living organism, for example, the microchip number, may be included.

(Record of communication between owner and doctor after alert)
When obtaining measurement data, the measurement results or judgment results are output to the owner terminal 61, the attending physician or hospital terminal 5, and when normal data is judged but an emergency condition is notified due to a data abnormality, a text information chat or voice communication line is secured, a display is displayed indicating that the line is available, and the system can record communications after the line is used.

Estimation of rectal temperature: A system can be created that processes data by using a constantly worn wearable transmitter in combination with an intestinal insertion examination device (pulse oximeter). Data from the intestinal insertion examination device (pulse oximeter) that is temporarily inserted into the intestine of the target individual organism is output to a wearable transmitter that is constantly worn on the individual organism, and the system can be equipped with an output section via the wearable transmitter.

At least the pulse rate and rectal temperature are measured using a measuring device (pulse oximeter), and the error in the calculation process of the estimated rectal temperature or the pulse rate can be displayed. For example, the rectal temperature is estimated by assuming that the times corresponding to the maximum and minimum rectal temperatures match the times corresponding to the maximum and minimum epidermal temperatures.

If oxygen saturation could be measured rectally, like body temperature measurement, it would reduce the effort required and improve the stability and reproducibility of the measurement values.

(Measurement principle)
There are two types of optical sensors: a transmission type that measures oxygen saturation by sandwiching the target blood vessel between a light emitting sensor and a receiving sensor, and a reflection type that does not sandwich the target blood vessel. The present invention is equipped with a reflection type pulse oximeter and a temperature sensor in its vicinity. By making the shaft shape thicker at the tip and equipping the sensor at the thicker part, more reliable measurements can be performed.

In addition to the above, the material constituting the flexible shaft 1 may be specifically a material in which a cover part 3 made of an elastic resin such as EVA resin is overcoated or irremovably attached around the elastically deformable shaft rod 100A. Alternatively, the material constituting the flexible shaft 1 may be a shaft rod 100A made of a metal material (a rod body with a shape memory alloy or a return spring material interposed therebetween) as a core material, and an outer skin material of an adherend may be attached around the core material. The base or tip of the shaft part of the flexible shaft 1, or the boundary with the tip bulge part 11, or a part of the axial direction of the adherend or the core material may be equipped with a free rotation mechanism that can automatically eliminate twisting, or a core material shaft rotation operation mechanism that rotates only the core material around its axis.

The present invention is not limited to the above-described embodiments, and various modifications, such as integrating or separating the components, increasing or decreasing the number of components, or combining with known components, or replacing some components, are possible without departing from the gist of the present invention. For example, the processing unit main body or its processing device and display device may be configured separately, or the 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 may be made in real time to a pre-set related terminal. Also, information obtained from different living animals may be accumulated and processed as statistical data for each type of living animal.

1 Flexible shaft 11 Tip swelling portion 11F Measurement surface 111 Bullet-shaped head portion 12 Shaft portion 121 122 Attachment structure 21 Display portion (output portion)
201, 206, 207 Notification section (display of discrimination result)
110S Optical sensor (reflective pulse oximeter)
110T Temperature sensor 100 Biological information measuring device 202 Time code 2 Processing unit main body 3 Cover part

Claims (5)

A biological information measuring device comprising: a rod-shaped measuring unit that is inserted into the rectum of a target animal to measure; 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 part is composed of a shaft part extending in a rod shape and a tip bulge part formed of a bulging head part provided at the axial end of the shaft part,
an optical sensor and a temperature sensor that detect a detection value by contacting an inner wall of the rectum are arranged in a specific circumferential direction of the distal end swelling portion;
The processing unit determines whether or not an abnormal measurement state is present based on the detection values of each sensor, an optical sensor and a temperature sensor, which are placed in contact with the rectal wall, and outputs this determination result, together with the detection values of each sensor, as the calculation data to the output unit as a signal. The biological information measuring device of claim 1 , characterized in that a measurement surface consisting of a flat or gently curved surface is formed in a specific circumferential direction of the bulging tip of the measuring part, and a reflective pulse oximeter and a temperature sensor targeting blood flow components in the inner wall of the rectum are arranged axially on this measurement surface. The bioinformation measuring device according to claim 1, characterized in that it has a continuous measurement function that measures the oxygen saturation of blood vessels or tissue oxygen saturation in rectal tissue intermittently or continuously for a predetermined period of time, and stores the measured value together with a time code to determine whether the detected value of the optical sensor falls within a predetermined threshold range of a certain fluctuation pattern, thereby determining whether the waveform is disturbed due to body movement or a change in posture. Further comprising a notification unit connected to the measurement unit by wire or wirelessly,
The biological information measuring device of claim 1, characterized in that the notification unit receives the calculated data output as a signal by the output unit via a wired or wireless connection, displays the sensor detection value, and notifies the determination result of an abnormal measurement state by notification means using sound, light, or display. The bioinformation measuring device according to claim 1, characterized in that the tip bulge, which is made of a convex rotating body or a prolate spheroidal head and has a contact-type sensor group consisting of an optical sensor and a temperature sensor built in, and the rod-shaped shaft section are abutted and joined together by an attachment structure or are detachably combined with each other.

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