WO2023149570A1

WO2023149570A1 - Biological tissue analysis method and device for detecting abnormality of biological tissue

Info

Publication number: WO2023149570A1
Application number: PCT/JP2023/003730
Authority: WO
Inventors: 高伸八木; 茂根本; 浩司山口
Original assignee: 株式会社根本杏林堂
Priority date: 2022-02-07
Filing date: 2023-02-06
Publication date: 2023-08-10

Abstract

The present invention provides a biological tissue analysis method. The biological tissue analysis method comprises: causing at least one light-emitting element 11Ma provided to a first leak detection sensor 10M to emit light so as to irradiate a first biological tissue 2a in the vicinity of a first blood vessel 1a, and receiving scattered light that has been scattered by the first biological tissue 2a with a light-receiving element 12M provided to the first leak detection sensor 10M; causing at least one light-emitting element 11Ra provided to a second leak detection sensor 10R to emit light so as to irradiate a second biological tissue 2b in the vicinity of a second blood vessel 1b which differs from the first blood vessel 1a, and receiving scattered light that has been scattered by the second biological tissue 2b with a light-receiving element 12R provided to the second leak detection sensor 10R; comparing an output value Main for light reception by the light-receiving element 12M with an output value Ref for light reception by the light-receiving element 12R and calculating a difference value Diff; and detecting an abnormality occurring in the first biological tissue 2a on the basis of the difference value Diff.

Description

Method for analyzing biological tissue and apparatus for detecting abnormalities in biological tissue

The present invention relates to a method for analyzing biological tissue and an apparatus for detecting abnormalities in biological tissue.

The administration of drug solutions, etc. into the patient's blood vessels is performed by inserting a needle into the cutaneous vein on the back of the hand or the forearm, and injecting the drug solution, etc. into the vein through the needle. A leakage detection system using an optical semiconductor element is used to determine whether or not a drug solution or the like has leaked out of a blood vessel.

In Patent Document 1, an optical measurement unit is arranged in a blood vessel into which an infusion solution is injected, light of a predetermined wavelength is irradiated toward the blood vessel, and the intensity of reflected light from the blood vessel is detected. An infusion monitoring device is disclosed that determines whether the infusion is leaking out of the blood vessel based on the intensity value.

Japanese Patent No. 6449069

The injection of the anticancer drug, which is a drug solution, into the blood vessel must be performed over a relatively long time of about 1 to 2 hours. Furthermore, anticancer drugs are highly toxic to normal cells, and extravasation of anticancer drugs is extremely dangerous, so visual observation is required at regular time intervals (15 minutes). However, if the infusion monitoring device of Patent Document 1 continues to monitor extravasation for a long period of time, the characteristic line (Base LINE, see FIG. 3 of Patent Document 1) that indicates the intensity of the reflected light may swell, causing extravasation. It may be difficult to determine whether the drug solution has leaked into the living tissue of the patient.

An object of the present invention is to provide a method for analyzing biological tissue.

To achieve the above object, the present invention provides a method for analyzing a biological tissue, which comprises causing at least one first light-emitting element provided in a first sensor to emit light to emit a first light in the vicinity of a first blood vessel. irradiating a biological tissue and receiving scattered light scattered by the first biological tissue with a first light receiving element provided in the first sensor; and at least one second sensor provided in the second sensor. illuminating a second biological tissue in the vicinity of a second blood vessel different from the first blood vessel by emitting light from two light emitting elements, and scattering light scattered by the second biological tissue to the second sensor; Light is received by a second light receiving element provided, and a change is detected by comparing a first measured value received by the first light receiving element and a second measured value received by the second light receiving element. and detecting an abnormality occurring in the first biological tissue based on the change.

According to the present invention, a method for analyzing biological tissue can be provided.

3 is a perspective view of the sensor head 15 of the leakage detection sensor 10 as seen from the contact surface 14 side. FIG. 2 is a plan view showing the arrangement of light emitting elements 11 and light receiving elements 12 mounted on a sensor head 15. FIG. 4 is a model diagram showing the principle of leak detection by the leak detection sensor 10. FIG. FIG. 2 is a model diagram showing the arrangement of light-emitting elements 11 and light-receiving elements 12 with respect to an irradiation target; It is a photograph which shows the test apparatus performed using a pig skin model. It is a photograph which shows the test apparatus performed using a pig skin model. 4 is a diagram showing output characteristics of the light receiving element 12 measured using a pig skin model; FIG. 4 is a diagram showing output characteristics of a light receiving element 12 when the blood vessel 1 is in a normal state; FIG. 1 is a schematic diagram showing a state of a blood vessel 1; FIG. 4 is a diagram showing output characteristics of a light receiving element 12 when a blood vessel 1 expands from a normal state; FIG. 1 is a schematic diagram showing a state of a blood vessel 1; FIG. FIG. 2 is a model diagram showing an example of veins on the back of the hand and the arrangement of each leakage detection sensor; FIG. 4 is a model diagram showing an example of veins in the forearm and the arrangement of each leakage detection sensor; FIG. 4 is a plan view showing the configuration of the first leakage detection sensor 10M; FIG. 11 is a plan view showing the configuration of a second leakage detection sensor 10R; It is a diagram showing a measurement result on the back of the hand in the embodiment. It is a diagram showing the measurement result in the forearm in the embodiment. FIG. 4 is a diagram showing measurement results on the back of the hand in an example. FIG. 4 is a diagram showing the measurement results of the forearm in the example. It is a figure which shows an application example typically.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. FIG. 1A is a perspective view of the sensor head 15 of the leakage detection sensor 10 used in the present invention, viewed from the contact surface 14 side. FIG. 1B is a plan view showing the arrangement of the light emitting element 11 and the light receiving element 12 mounted on the sensor head 15. FIG.

The sensor head 15 is used by being fixed in close contact with the patient during drug injection, and has four light-emitting elements 11 and one light-receiving element 12 . The light-emitting element 11 is an element that emits light of a predetermined wavelength when a voltage is applied. As the light-emitting element 11, for example, a light-emitting diode that emits infrared rays can be used. The light-receiving element 12 is an element that receives at least light of a wavelength emitted by the light-emitting element 11 and converts the light-receiving energy into electric energy, and an electric output is obtained from the converted electric energy. For example, a phototransistor can be used as the light receiving element 12 .

In this embodiment, the leakage detection sensor 10 is provided with four light emitting elements 11 and one light receiving element 12. The light emitting element 11 and the light receiving element 12 are mounted on the substrate 13 and fixed inside the sensor head 15 . The light-receiving element 12 is mounted at a position corresponding to the center of the contact surface 14 of the sensor head 15, and the four light-emitting elements 11 surround the light-receiving element 12 at equal distances from the light-receiving element 12 at equal angular intervals. Implemented. With such an arrangement, the center of the light-emitting region of all the light-emitting elements 11 and the center of the light-receiving region of the light-receiving element 12 are aligned. Since the present embodiment has four light emitting elements 11, these light emitting elements 11 are arranged at intervals of 90 degrees around the light receiving element 12. FIG.

Next, the operation of the leakage detection sensor 10 of this embodiment will be described. FIG. 2A is a model diagram showing the principle of detection of leakage of a chemical or the like by the leakage detection sensor 10. FIG. FIG. 2B is a model diagram showing the arrangement of the light-emitting element 11 and the light-receiving element 12 that irradiate the vicinity of the blood vessel 1, the blood vessel 1, and the living tissue 2 in the vicinity thereof. Prior to securing the sensor head 15 to the subject, an injection needle 4 (needle) is punctured into the patient's blood vessel 1 . The injection needle 4 is punctured into a vein in either the patient's forearm or the back of the hand, but may be punctured in a vein at another site. After the injection needle 4 is punctured, the sensor head 15 is fixed to the patient using an adhesive sheet or the like so that the center of the sensor head 15 is positioned almost directly above the punctured tip of the injection needle 4 .

FIG. 2A also shows a blister 6 caused by leakage of a drug solution (for example, an anticancer drug) from the injection needle 4. In an experiment for detecting leakage of a drug solution, a dummy sample was used. used. 3A and 3B are photographs showing an experimental apparatus for detecting leakage using a pig skin model as a dummy sample. FIG. 4 is a diagram showing output characteristics of the light receiving element 12 measured using a pig skin model.

In the pig skin model, an injection needle 4 is pierced into the pig skin 5 , a leakage detection sensor 10 is arranged directly above the injection needle 4 , water is injected into the pig skin 5 through the injection needle 4 , and blisters 6 are artificially formed. It is made possible to form The formed blister 6 is regarded as the liquid medicine leaked from the injection needle 4 in this pig skin model. Then, the leakage detection sensor 10 is driven to cause the light emitting element 11 to emit light, the light receiving element 12 detects the scattered light from the surrounding tissues including the blister 6, and the output value is measured. The pig skin 5 used in the experiment is pig abdominal skin and has a thickness of 2 mm for the epidermis and 2 mm for the subcutaneous layer. These two pieces of pig skin 5 form a sandwich structure. A 23G (winged needle) is used as the injection needle 4 . The puncture position of the injection needle 4 is directly below the leak detection sensor 10 . Water is injected in increments of 0.2 ml for a total of 3 ml of water. The water used is physiological saline.

First, 0.2 ml of water is injected from the injection needle 4 at a time, and the blister 6 grows accordingly. The blister 6 reproduces the leakage of the drug solution. The light emitting element 11 emits light to the surrounding tissue including the blister 6, and the value detected by the light receiving element 12 is measured. FIG. 4 shows plots A to C, which are three measurement results of the light receiving element 12. Plot A is the result when it is estimated that the blister 6 was formed at the farthest point from the light receiving element 12. It is a characteristic in which the output value of the light receiving element 12 is described. Plot C is a characteristic describing the output value of the light receiving element 12 when it is estimated that the bubble 6 is formed at the point closest to the light receiving element 12 (for example, immediately below the light receiving element 12). Plot B is an intermediate characteristic between plots A and C.

As shown in FIG. 4, the output value of the light receiving element 12 attenuates as the injection amount of water corresponding to the leak amount of the chemical solution increases. Also, when the bubble 6 is close to the light receiving element 12, the output value of the light receiving element 12 is greatly attenuated. That is, when the light receiving element 12 is located near the blister 6, it can be said that the sensitivity for detecting leakage of the chemical solution is higher. Then, for example, when the output value of the light receiving element 12 drops to 0.7 V (the cutoff value), it can be estimated that there was a leak of 2 ml or more in plot A, while 0.5 ml in plot B and 0.5 ml in plot C It can be estimated that there was a leak of 0.25ml. Since the flow rate of anticancer drug injection is 1 to 3 ml/min, it can be said that leakage can be detected in about 1 minute after the drug begins to leak.

As described above, the experiment using the pig skin model confirmed that the leak detection sensor 10 could detect the blister 6 corresponding to the leak in the skin. Furthermore, it was confirmed that the leakage amount can be estimated by the leakage detection sensor 10 from the plot characteristics and the measurement time by setting the predetermined output value as the cutoff value as described above.

Next, an experiment was conducted in which the leakage detection sensor 10 was placed on the skin of a healthy subject, for example, just above the vein on the back of the hand, and the output value of the light receiving element 12 was measured. FIG. 5A is a diagram showing output characteristics of light receiving element 12 when blood vessel 1 is in a normal state. FIG. 5B is a schematic diagram showing the state of the blood vessel 1. FIG. Administration of the contrast agent takes a relatively short time (about 15 seconds to 1 minute), but administration of the anticancer agent takes a relatively long time. Assuming the time during which the cancer drug is administered, it is a relatively long time of 1200 seconds (20 minutes). The left vertical axis is the sensor internal temperature [° C.] of the leakage detection sensor 10 and the right vertical axis is the sensor output [V] of the light receiving element 12 .

The output value of the light-receiving element 12 may have a sharp spike-like rise in a constant period of about 200 seconds to about 400 seconds. This spike-like steep rising lasts for about 1 minute, and is presumed to be of biological origin. Assuming that the output value of the light receiving element 12 is 0.8 V and that the output value of the light receiving element 12 is 0.8 V, the output value of the light receiving element 12 is within a range of ±0.02 V with respect to the baseline BL1. is periodically fluctuating. It should be noted that the internal temperature of the leak detection sensor 10 was substantially constant during the experiment, and the blood vessel 1 was in a normal state, not dilated and not contracted, as shown in FIG. 5B.

FIG. 6A is a diagram showing output characteristics of the light receiving element 12 when the blood vessel 1 expands from its normal state. FIG. 6B is a schematic diagram showing the state of the blood vessel 1. FIG. The vertical axis and horizontal axis in FIG. 6A are the same as in FIG. 5A.

As in the case where the blood vessel 1 is in a normal state, the output value of the light-receiving element 12 shows a sharp spike-like rise with a duration of about 1 minute. Then, if this spike-like rise is excluded and the output value of the light receiving element 12 of 0.8 V is used as a reference baseline BL1, the output value of the light receiving element 12 is As indicated by the arrow, the whole is shifted downward from the baseline BL1. This deviation is hereinafter referred to as "drift". Then, the output value of 0.76 V is set as a new baseline BL2, and the voltage fluctuates periodically within a range of about ±0.02 V with respect to this baseline BL2. It should be noted that the internal temperature of the leak detection sensor 10 is substantially constant during the experiment.

As shown in FIG. 6B, the blood vessel 1 expands from the normal state in FIG. 5B and has a larger cross-sectional area. That is, at the beginning of the experiment, the blood vessel 1 was in a normal state, but it can be inferred that the blood vessel 1 dilated during the passage of about 400 seconds. , is presumed to have drifted as indicated by the arrows. It is presumed that this dilation of the blood vessel 1 is caused by poor blood circulation due to posture maintenance. If the baseline BL1 of the output value of the light receiving element 12 changes to the baseline BL2 due to the dynamic change of the blood vessel 1, it is difficult to use the sensor output value to detect leakage. However, according to the present invention, leakage of the drug solution from the biological tissue 2 including dynamic changes can be detected accurately by the method described below.

FIG. 7A is a model diagram showing an example of veins on the back of the hand and the arrangement of the first leak detection sensor 10M (first sensor) and the second leak detection sensor 10R (second sensor). FIG. 7B is a model diagram showing an example of veins in the forearm and the arrangement of the first leakage detection sensor 10M and the second leakage detection sensor 10R. Administration of the anticancer drug is performed through the injection needle 4 which is punctured by the injection needle 4 into the first blood vessel 1a which is, for example, one of the veins in the back of the hand or the forearm. In the present invention, the first leakage detection sensor 10M is arranged directly above the first blood vessel 1a downstream of the position where the injection needle 4 is punctured, and is located near the first blood vessel 1a. Tissue 2a is irradiated. Similarly, a second leakage detection sensor 10R is placed directly above a second blood vessel 1b different from the first blood vessel 1a, and irradiates a second living tissue 2b in the vicinity of the second blood vessel 1b. That is, two leak detection sensors 10 are used to measure light scatter in each vein. Experiments in which anticancer drugs are actually administered to healthy subjects are highly risky and unrealistic. Therefore, by processing the drift of the output value of the leak detection sensor 10 due to dilation or contraction of the vein without administering the drug solution, the leakage of the drug solution can be detected by the leak detection sensor 10 in a developmental manner. .

Both FIGS. 8A and 8B show the configurations of the first leakage detection sensor 10M and the second leakage detection sensor 10R, respectively. The first leak detection sensor 10M includes two light emitting elements 11Ma that are arranged to face each other and form a first pair, two light emitting elements 11Mb that are arranged to face each other and form a second pair, and one light receiving element 12M. have Similarly, the second leakage detection sensor 10R includes two light emitting elements 11Ra that are arranged to face each other and form a first pair, two light emitting elements 11Rb that are arranged to face each other and form a second pair, and one light emitting element 11Rb. It has a light receiving element 12R. It is desirable that both the first blood vessel 1a in which the first leakage detection sensor 10M is arranged and the second blood vessel 1b in which the second leakage detection sensor 10R is arranged have the same diameter. . Both the location where the first leakage detection sensor 10M is arranged and the location where the second leakage detection sensor 10R is arranged should preferably have a substantially straight vein, and should not be located near a bifurcation of the vein.

As described above, the first leak detection sensor 10M is placed directly above the first blood vessel 1a, and the second leak detection sensor 10R is placed directly above the second blood vessel 1b. 2 leak detection sensor 10R. In this embodiment, the two light emitting elements 11Ma and the two light emitting elements 11Mb are all caused to emit light at the same timing. Similarly, the two light emitting elements 11Ra and the two light emitting elements 11Rb are caused to emit light at the same timing. It should be noted that, of the two light emitting elements 11Ma and the two light emitting elements 11Mb, at least one light emitting element 11Ma (first light emitting element) may emit light. Similarly, of the two light emitting elements 11Ra and the two light emitting elements 11Rb, at least one light emitting element 11Ra (second light emitting element) may emit light.

FIG. 9 is a diagram showing the results of measurement by arranging the first leak detection sensor 10M and the second leak detection sensor 10R on the back of the hand in the embodiment. The characteristics of the output value Main of the first leak detection sensor 10M, the output value Ref of the second leak detection sensor 10R, and the difference value Diff obtained by subtracting the output value Ref from the output value Main are shown.

Fig. 9 also shows the measurement results for the stationary state, intermittent movement, and continuous movement of the hand. In the stationary state, the output value Main and the output value Ref decrease (drift) over time as indicated by the arrows. This drift is presumed to be due to venous dilation as described above. On the other hand, the characteristic of the difference value Diff is within the range of ±0.05 V even after time passes.

In addition, when the wrist is intermittently moved at a height of 0 to 10 cm, the characteristic of the difference value Diff is within the range of ±0.05 V even after the passage of time. On the other hand, when the finger is continuously moved, the characteristic of the difference value Diff does not fall within the range of ±0.05V. For example, when a hand is clenched, since the blood vessels extending to the middle finger and the thumb have different elongation degrees, the change in the inner diameter is also different, so that the movement of the fingertips cannot be accommodated.

FIG. 10 is a diagram showing the results of measurement by arranging the first leak detection sensor 10M and the second leak detection sensor 10R on the forearm in the embodiment. The characteristics of the output value Main of the first leak detection sensor 10M, the output value Ref of the second leak detection sensor 10R, and the difference value Diff obtained by subtracting the output value Ref from the output value Main are shown.

In addition, Fig. 10 shows the measurement results in the static state, intermittent motion, and continuous motion. In the stationary state, the output value Main and the output value Ref decrease (drift) over time as indicated by the arrows. This drift is presumed to be due to venous dilation as described above. On the other hand, the characteristic of the difference value Diff is within the range of ±0.05 V even after time passes.

In addition, when the forearm is intermittently moved to an angle of 0 to 45 degrees, the characteristic of the difference value Diff is within the range of ±0.05 V even after the passage of time. Furthermore, even when the finger is intermittently or continuously moved, the characteristic of the difference value Diff is within the range of ±0.05V. This is because, for example, when the hand is clenched, the change in the inner diameter of the blood vessel is considered to have little effect on the forearm.

In this embodiment, two leakage detection sensors measure the scattered light of the living tissue 2 around the veins for two different veins. It was then shown that biologically derived data noise, such as venous dilatation, can be eliminated by the two leak detection sensors.

More specifically, when medication is administered to the first blood vessel 1a by the infusion needle 4 and leakage occurs at that time, the output value from the first leakage detection sensor 10M arranged directly above the first blood vessel 1a It is assumed that Main is attenuated (see FIG. 4). On the other hand, the output value Ref from the second leakage detection sensor 10R arranged directly above the second blood vessel 1b different from the first blood vessel 1a does not attenuate. Then, when leakage of the chemical solution occurs, it is expected that the difference value Diff obtained by subtracting the output value Ref from the output value Main deviates from the range of ±0.05V. As described above, it is possible to detect leakage of the chemical solution.

That is, the method for analyzing biological tissue including dynamic changes according to the embodiment of the present invention causes at least one light-emitting element 11Ma (first light-emitting element) provided in the first leakage detection sensor 10M to emit light to generate the first irradiates the first living tissue 2a in the vicinity of the blood vessel 1a. Scattered light scattered by the first living tissue 2a is received by the light receiving element 12M (first light receiving element) provided in the first leak detection sensor 10M. Similarly, at least one light-emitting element 11Ra (second light-emitting element) provided in the second leakage detection sensor 10R is caused to emit light so that a second blood vessel 1b near a second blood vessel 1b different from the first blood vessel 1a is detected. of the living tissue 2b. Scattered light scattered by the second living tissue 2b is received by the light receiving element 12R (second light receiving element) provided in the second leak detection sensor 10R. Then, the output value Main (first measured value) received by the light receiving element 12M is compared with the output value Ref (second measured value) received by the light receiving element 12R to calculate the difference value Diff (change). An abnormality occurring in the first living tissue 2a is detected based on the change.

The change may be obtained from, for example, a difference value, a ratio value, or a correlation value between the output value Main received by the light receiving element 12M and the output value Ref received by the light receiving element 12R. Abnormality of the first living tissue 2a means that, for example, a drug solution is leaking around the first blood vessel 1a. Further, according to the embodiments of the present invention, it is possible to provide a method for analyzing biological tissue.

(Example)
Examples of the present invention will now be described. In this embodiment, two light emitting elements 11Ma (one group of light emitting elements) forming a first pair and two light emitting elements 11Mb (two groups of light emitting elements) forming a second pair in the first leakage detection sensor 10M are used. light-emitting elements) are caused to emit light at different timings. The same is true for the second leakage detection sensor 10R.

Regarding the first leak detection sensor 10M, first, the two light emitting elements 11Ma constituting the first pair emit light, the light receiving element 12M receives the light, and outputs the output value Ma. Next, the two light-emitting elements 11Mb forming the second pair emit light, the light-receiving element 12M receives the light, and outputs the output value Mb. Then, the received light energy is averaged by the following formula.
Average value Mave=(Ma+Mb)/2
Similarly, for the second leakage detection sensor 10R, first, the two light emitting elements 11Ra (one group of light emitting elements) forming the first pair emit light, the light receiving element 12R receives the light, and outputs the output value Ra. . Next, the two light-emitting elements 11Rb (second group of light-emitting elements) forming the second pair emit light, the light-receiving element 12R receives the light, and outputs an output value Rb. Then, the received light energy is averaged by the following formula.
Average value Rave=(Ra+Rb)/2

FIG. 11 is a diagram showing the measurement results obtained by arranging the first leakage detection sensor 10M and the second leakage detection sensor 10R on the back of the hand in the example. Output value Ma from first leak detection sensor 10M, output value Mb and its average value Mave, output value Ra from second leak detection sensor 10R, output value Rb and its average value Rave, average value from average value Mave The characteristics of the difference value Diff with Rave subtracted are shown. In FIG. 11, the reference lines (baselines) of the output value Ma, the output value Mb, the output value Ra, and the output value Rb do not decrease over time. Although dilation occurs in the veins as described above, drift due to dilation is eliminated in the example. The characteristic of the difference value Diff is within the range of ±0.05 V even after time passes.

FIG. 12 is a diagram showing the measurement results obtained by arranging the first leak detection sensor 10M and the second leak detection sensor 10R on the forearm in the example. Output value Ma from first leak detection sensor 10M, output value Mb and its average value Mave, output value Ra from second leak detection sensor 10R, output value Rb and its average value Rave, average value from average value Mave The characteristics of the difference value Diff with Rave subtracted are shown. In FIG. 12, the reference lines (baselines) of the output value Ma, the output value Mb, the output value Ra, and the output value Rb do not decrease over time. Although dilation occurs in the veins as described above, drift due to dilation is eliminated in the example. The characteristic of the difference value Diff is within the range of ±0.05 V even after time passes.

All of the two light emitting elements 11Ma and the two light emitting elements 11Mb may be driven at the same time, or may be driven with different light emission timings, or a combination of these, simultaneous driving and driving with different light emission timings. and may be repeated alternately. By driving all the light emitting elements 11 at the same time, a large amount of light can be obtained, so leakage from a deeper part than the body surface can also be detected.

(Application example)
A device 100 to which the analysis method according to the embodiment or example of the present invention is applied will be described below with reference to FIG. 13 . FIG. 13 is a diagram schematically showing an apparatus 100 to which the analysis method according to the embodiment or example of the present invention is applied.

A device 100 for notifying an abnormality occurring in a living tissue 2 includes at least one first light emitting element 11Ma that irradiates the vicinity of a first blood vessel 1a, and receives scattered light scattered in the vicinity of the first blood vessel 1a. A first leakage detection sensor 10M is provided, which is composed of a first light receiving element 12M. Furthermore, at least one second light emitting element 11Ra for illuminating the vicinity of a second blood vessel 1b different from the first blood vessel 1a, and a second light receiving element for receiving scattered light scattered in the vicinity of the second blood vessel 1b. and a second leakage detection sensor 10R configured with an element 12R. It also has control means 101 and well-known notification means 102 .

Then, using the analysis method for the biological tissue 2 in the embodiment or example of the present invention, an abnormality occurring in the vicinity of the first blood vessel 1a is detected. The detection is performed by analyzing each output value from the first leakage detection sensor 10M and the second leakage detection sensor 10R in the control means 101. FIG. The analyzed result can be displayed on a display or the like, which is a well-known notification means 102, or notified by a buzzer or light. Thus, the device 100 for detecting abnormalities in the living tissue 2 can be provided.

As described above, the present invention has been described by the representative embodiments and examples, but the present invention is not limited to the above-described embodiments and examples, and can be arbitrarily changed within the scope of the technical idea of the present invention. be able to.

This application claims priority from Japanese Patent Application No. 2022-17450 filed on February 7, 2022, and is incorporated herein by reference in its entirety.

1a first blood vessel 1b second blood vessel 2 biological tissue 2a first biological tissue 2b second biological tissue 4 injection needle (needle)
10M first leak detection sensor (first sensor)
10R Second leak detection sensor (second sensor)
11Ma light-emitting element (first light-emitting element, first group of light-emitting elements)
11 Mb light-emitting element (2 groups of light-emitting elements)
11Ra light emitting element (second light emitting element, first group of light emitting elements)
11Rb light emitting element (2 groups of light emitting elements)
12M light receiving element (first light receiving element)
12R light receiving element (second light receiving element)
100 Device Diff Difference value (change)
Main output value (first measured value)
Mave Average value Rave Average value Ref Output value (second measured value)

Claims

A biological tissue analysis method comprising:
At least one first light-emitting element provided in the first sensor emits light to irradiate the first living tissue in the vicinity of the first blood vessel, and the scattered light scattered in the first living tissue is emitted to the first living tissue. receiving light with a first light receiving element provided in one sensor;
At least one second light-emitting element provided in a second sensor is caused to emit light to irradiate a second biological tissue in the vicinity of a second blood vessel different from the first blood vessel, and the second biological tissue is irradiated with light. receiving the scattered light scattered by the second light receiving element provided in the second sensor;
calculating a change by comparing a first measured value received by the first light receiving element and a second measured value received by the second light receiving element;
and detecting an abnormality in the first biological tissue based on the change.
The first light emitting element illuminates the first blood vessel and the first living tissue, and the second light emitting element illuminates the second blood vessel and the second living tissue. The analysis method according to claim 1, characterized by:
The analysis method according to claim 1 or 2, wherein the change is obtained from a difference value, a ratio value, or a correlation value between the first measured value and the second measured value.
The first light emitting element provided in the first sensor is composed of one group of light emitting elements and two groups of light emitting elements,
4. The method according to any one of claims 1 to 3, wherein the second light emitting element provided in the second sensor is composed of one group of light emitting elements and two groups of light emitting elements. Analysis method described.
irradiating the first living tissue by alternately causing the first group of light emitting elements and the second group of light emitting elements constituting the first light emitting element to emit light;
5. The method according to claim 4, wherein the first group of light emitting elements and the second group of light emitting elements constituting the second light emitting element are alternately caused to emit light to irradiate the second living tissue. analysis method.
The first measured value is an average value of the measured value of the scattered light by the irradiation of the first group of light emitting elements and the measured value of the scattered light by the irradiation of the second group of light emitting elements in the first sensor, The second measured value is an average value of the measured value of the scattered light by the irradiation of the first group of light emitting elements and the measured value of the scattered light by the irradiation of the second group of light emitting elements in the second sensor. The analysis method according to claim 4 or 5, characterized by:
The first sensor is composed of the first light emitting element having four light emitting elements and the first light receiving element,
The second sensor according to any one of claims 1 to 6, wherein the second sensor is composed of the second light-emitting element having four light-emitting elements and the second light-receiving element. analysis method.
The analysis method according to any one of claims 1 to 7, characterized in that the first blood vessel is punctured by a needle for injecting a drug solution.
The analysis method according to claim 8, wherein the abnormality is leakage of the drug solution that occurs around the first blood vessel.
a first sensor composed of at least one first light-emitting element that irradiates the vicinity of a first blood vessel and a first light-receiving element that receives scattered light scattered in the vicinity of the first blood vessel;
At least one second light emitting element for illuminating the vicinity of a second blood vessel different from the first blood vessel, and a second light receiving element for receiving scattered light scattered in the vicinity of the second blood vessel. A device for detecting an abnormality in a biological tissue, comprising:
10. An apparatus for detecting abnormalities occurring in the vicinity of said first blood vessel by the analysis method according to any one of claims 1 to 9.