Portable biological information observation device and portable biological information observation system

Abstract

To provide a small, easy-to-handle portable biological information observation device. [Solution] A portable bio-information observation device according to one embodiment of the present invention is a portable bio-information observation system comprising at least an irradiation device that irradiates a part to be observed with photon energy, an imaging device that captures the visualized part to be observed as a visualization image and generates a visualization image signal, a display device, and an operation unit, wherein the system comprises at least a main body having the irradiation device, the imaging device, and the display device, the main body having a photon energy emission unit and an imaging unit on one side of its opposing surface, a display unit on the other side of the opposing surface, and an illumination control unit that controls the visualization light of the illumination device, the illumination control unit controlling the irradiation device that irradiates the photon energy to have a wavelength, brightness, and brightness distribution set according to the visualization conditions of the part to be observed, based on a command from the operation unit.

Description

Technical Field

[0001] The present invention relates to a portable biological information observation device and a portable biological information observation system.

Background Art

[0002] Conventionally, as a device for observing biological information, for example, a visualization image of the lymphatic system, Patent Document 1 discloses a lymphatic system function evaluation device that administers a visualization agent to the human body and irradiates light to visualize the lymphatic system and observes the visualization image of the lymphatic system with an imaging device.

[0003] Also, for example, as a device for observing an image of the pupil, Patent Document 2 discloses a photorefractor including an imaging optical system that photographs illumination light from an illumination light source reflected by the fundus of the test eye, position detection means for detecting the separation distance between the imaging optical system and the test eye, and an image processing arithmetic unit that analyzes the captured image by the imaging optical system.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0005] Since the lymphatic system function evaluation device of Patent Document 1 includes devices such as a camera unit including an imaging device and a light irradiation device, a lymphatic system function evaluation device, an input device, and a display, it is a large-scale device and is used in a state installed in a dedicated examination room or the like. Therefore, for example, even when the observed part is a part of the body or when performing preliminary observation, there is a problem that the subject can only observe the visualization image of the lymphatic system in a dedicated examination room.

[0006] The photorefractor described in Patent Document 2 is a device that arranges multiple point light sources in a horizontal row from left to right as illumination sources, selectively lights up one of the point light sources, and observes a bright crescent in the pupil corresponding to this point light source. Therefore, the light source is limited to a point light source, and the application of this technology is limited to a photorefractor for observing the image of the pupil.

[0007] The present invention has been made in view of the above circumstances, and aims to provide a compact and easy-to-handle portable biological information observation device or portable biological information observation system. [Means for solving the problem]

[0008] A portable bio-information observation device according to one embodiment of the present invention comprises at least an irradiation device that irradiates a part to be observed with photon energy, an imaging device that captures the part to be observed visualized by the irradiation of the visualization light from the irradiation device as a visualization image and generates a visualization image signal of the part to be observed, a display device that displays the visualization image signal generated by the imaging device, and an operation unit, wherein the portable bio-information observation system comprises at least a main body having the irradiation device, the imaging device, and the display device, the main body having at least a pair of opposing surfaces, one of the opposing surfaces having a photon energy emission section of the irradiation device and the imaging section of the imaging device, the other surface of the opposing surface having a display section of the display device, and an illumination control unit that controls the visualization light of the illumination device, the illumination control unit controlling the irradiation device that irradiates the photon energy to have a wavelength, brightness, and brightness distribution set according to the visualization conditions of the part to be observed, based on a command from the operation unit. [Effects of the Invention]

[0009] According to a portable biological information observation device of one embodiment of the present invention, it is possible to provide a compact and easy-to-handle portable biological information observation device or portable biological information observation system. [Brief explanation of the drawing]

[0010] [Figure 1] This is a block diagram of a portable biological information observation device according to the first embodiment of the present invention. [Figure 2] This is a front view of a portable biological information observation device according to Embodiment 1 of the present invention. [Figure 3] This is a rear view of a portable biological information observation device according to Embodiment 1 of the present invention. [Figure 4] This is a side view of a portable biological information observation device according to Embodiment 1 of the present invention. [Figure 5] This is a perspective view of a portable biological information observation device according to Embodiment 1 of the present invention. [Figure 6] This is an example of a visible image of a lymphatic system including multiple systems, obtained by a portable biological information observation device according to Embodiment 1 of the present invention. (A) is an example of the display unit, and (B) is a trace diagram of the lymphatic system. [Figure 7] This is an example of a visible image including the lymphatic system and blood vessels obtained by a portable biological information observation device according to Embodiment 2 of the present invention. (A) is an example of the display unit, and (B) is a trace diagram of the lymphatic system. [Figure 8] This is an example of a visible image of sweat glands obtained using a portable biological information observation device according to Embodiment 2 of the present invention. Figure 8A is a fluorescence image of a dye phototherapy agent containing ICG. Figure 8B is a toluidine blue stained image of the region corresponding to Figure 8A. [Figure 9] This is a fluorescence image of sweat gland cells when a dye phototherapy agent according to Embodiment 2 of the present invention is added and irradiated with light. [Figure 10] Figure 9 shows a toluidine blue stained image of sweat gland cells. [Figure 11] These are stained images of hair follicle cells using a dye phototherapy agent containing ICG, as measured by a portable biological information observation device according to Embodiment 2 of the present invention. Figure 11A is a wide-area image, and Figure 11B is a magnified portion of Figure 11A. [Modes for carrying out the invention]

[0011] Hereinafter, a portable biological information observation device and a portable biological information observation system according to an embodiment of the present invention will be described with reference to the drawings. However, the embodiments shown below are examples of a portable biological information observation device for embodying the technical idea of the present invention, and do not specify the present invention thereto. The present invention can be equally applied to other embodiments included in the claims.

[0012] The portable biological information observation device according to Embodiment 1 of the present invention will be described with reference to FIGS. 1 to 6.

[0013] FIG. 1 is a block diagram of a portable biological information observation device 10 according to Embodiment 1 of the present invention. FIG. 2 is a front view of the portable biological information observation device according to Embodiment 1 of the present invention. FIG. 3 is a rear view of the portable biological information observation device according to Embodiment 1 of the present invention. FIG. 4 is a side view of the portable biological information observation device according to Embodiment 1 of the present invention. FIG. 5 is a perspective view of the portable biological information observation device according to Embodiment 1 of the present invention.

[0014] The portable biological information observation device 10 includes a main body unit 11. The main body unit 11 has a pair of opposing surfaces. On one of the opposing surfaces, an emission unit 21 of the visualization light of the irradiation device 20 and an imaging unit 31 of the imaging device 30 are provided. On the other of the opposing surfaces, a display unit 41 of the display device 40 is provided. Further, a control device 50 is provided in the main body unit. The control device 50 is connected to an external system 60 via wireless communication such as Wi-Fi, Bluetooth, etc. The external system includes an image analysis device 61 that analyzes a visualization image captured by the imaging device 30 of the portable biological information observation device 10, and an enlarged display device 62 that enlarges and displays the image information analyzed by the image analysis device or the visualization image captured by the imaging device 30.

[0015] The portable biological information observation device 10 of the present invention has the following functions a) to h). a) It is possible to use the entire surface around the camera on the surface as an illumination device. b) The front surface of the back side can be used as a monitor. c) A rod-shaped grip part that supports the imaging / monitoring part is provided on the lower surface. d) There are protrusions on the vertical front surface from the grip part, improving the holding force. e) The operability grip and operation buttons by a switch operable with the thumb or index finger are easy to operate with one hand. f) Using an LED as the light source of the lighting device to evenly illuminate the observed part. Also, it is preferable to penetrate the skin and irradiate deep inside. In the case of a handy type at a short distance, the brightness of the emitted light of the LED is sufficient to penetrate the skin. That is, there is no need to use laser light. g) Multiple LEDs are arranged, and optical elements such as collimators, lenses, etc. can be omitted. h) A function to control the irradiation of the LED according to the fluorescence conditions of the fluorescent agent.

[0016] [1. Intensity of infrared rays] (1) Conventionally, from 0 (off) to 10 (maximum). (2) In this application, preset Strong: Deep part (appropriately set from 5 to 10) Weak: Skin surface (1 - 2) Medium: Intermediate value (3) Realized by a collimated light LED array. Even in the handy type, a wide range can be observed by panoramic shooting. Although the imaging range of the camera in the handy type is limited, by the panoramic shooting function, a panoramic image can be obtained by synthesizing the imaging information obtained by moving the camera along the observed part through image processing. From this panoramic image, a visualized image over a wide range of the observed part can be obtained. (4) A 3D fluorescence image can be obtained from fluorescence images with different depths. Image data with depth can be obtained.

[0017] The light source section of the irradiation device's output unit has multiple LEDs arranged, for example, in a matrix. The output unit of the irradiation device utilizes the straight-line propagation of LED light to emit visualization light that is uniform and parallel across the entire surface area of ​​the output unit. Because it utilizes the straight-line propagation of LED light, there is no need to attach optical components such as separate optical sheets or separate collimating lenses to the output surface side of the output unit. Such a light source is generally called a surface light source, but in this embodiment, the output unit does not only mean uniformly distributing the light source across the entire surface, but also includes any light source unit as long as the light emitted from the output unit is substantially parallel light. For example, a ring-shaped light source also achieves a uniform brightness distribution, so it is included as a form of output unit.

[0018] For example, the control panel can include a first switch (a switch for switching between video and still images) and a second switch (a preset switch for infrared intensity).

[0019] [2. Expansion of the scope of application] 2-1. Lymphatic System Indocyanine green (hereinafter referred to as "ICG") can be used as a visualization agent. When visualizing the lymphatic system with visualization light, for example, ICG can be injected into the lymphatic system as a visualization agent, and then near-infrared light can be used as the visualization light. In this embodiment, the combination of visualization light and visualization agent is not limited to this, and any combination can be adopted as long as the observed part can be visualized. For example, any photon energy including at least one of visible light, infrared light, near-infrared light, ultraviolet light, and laser light can be used as the visualization light. Furthermore, depending on the visualization light and the observed part, it is possible to choose to use a visualization agent containing at least one of ICG, patent blue, indigo carmine, lipiodol, isosulfan blue, iopamilon, heptamethyl resinate dye, protoproferiin, or organic anion transporter (OATP), or not to use a visualization agent. Similarly, for areas other than the lymphatic system, the combination of visualization light and visualization agent is not limited to the following examples, but any combination can be used as long as it allows visualization of the area being observed. 2-2. Blood Vessels can be visualized by injecting visualization agents such as ICG. Furthermore, because hemoglobin absorbs light, when light is shone on the area being observed, the resulting shadows can be visualized as blood vessels. In this case, since blood vessels can be visualized without using a visualization agent, it becomes possible to choose whether or not to use a visualization agent. 2-3. Subcutaneous tissue The portable biological information observation device of this embodiment can visualize not only the lymphatic system and blood vessels, but also subcutaneous tissue such as sweat glands and hair follicles. For the visualization of sweat glands, for example, ICG can be used as a visualization agent. For the visualization of hair follicles, for example, ICG can be used as a visualization agent.

[0020] [3. Wavelengths of infrared radiation] The practical brightness is, for example, 760 nm (near-infrared 700 nm to 1000 nm). The upper limit of visible light (red) is approximately 760 to 850 nm. Here, the use of near-infrared light is exemplified as the emission unit of the illumination device 20, the emission unit of the visualization light 21, as the photon energy emission unit. However, this embodiment is not limited to this, and any photon energy can be used as long as it can be used as visualization light. For example, ultraviolet light, infrared light, visible light, electromagnetic waves, X-rays, etc., can be used as long as they can be visualized by an imaging device such as a camera.

[0021] [4. Configuration of the operating switch] (1) Example of a thumb-side switch Switching between still images and videos is possible, for example, by a single press or long press of a switch. The grip and switch are designed so that the switch can be operated while holding the device with one hand. For example, the switch can be pressed with the thumb. (2) Example of an index finger switch on the light source side With the three preset modes (strong, medium, and weak), you can select the setting with a single switch. Previously, with a selection of 0-10, you had to use an up / down switch to adjust the setting, making one-handed adjustment difficult.

[0022] [5. Convenient Features] (1) By mirroring the handheld monitor, it can be viewed on a larger screen. Image data can be transferred to an external system via wireless communication such as Wi-Fi or Bluetooth. (2) Power saving enables battery operation. Cordless operation is important in the field. For example, sterile procedures are required in the operating room. It is easier to handle without a power cord. On the other hand, if the battery is heavy or if long operating time is required, an external power source can be used. The size of the battery is envisioned to be similar to that of a power tool battery. (3) As a free arm, it can also be fixed. Various specifications are possible, such as fixing it to a stand, fixing it to the ceiling, fixing it with a headband, making the gripping bar detachable, or changing the fixing fittings. For example, a) gripping bar, b) hanging from the ceiling, and c) headband (freehand) are possible. To make it freehand, a screw-fastening part is provided on the gripping bar. As shown in Figures 2 to 5, the arm mounting hole is provided in the center of the bottom surface of the main body. In addition, multiple arm mounting holes are provided on the surrounding surfaces other than the opposing surface of the main body, and in this embodiment, as shown in Figure 4, in addition to the bottom surface of the main body, an arm mounting hole is also provided in the center of the right side surface of the main body, and by changing the arm mounting position, it is possible to switch the screen between portrait and landscape orientation. (4) Since the arm is angle-adjustable and extendable, the camera can be positioned in the desired orientation, and the display device can also be positioned in a way that is easy for the operator to view.

[0023] [Test Example 1] Visualization of the lymphatic system Figure 6 shows an example of a visible image obtained by a portable biological information observation device according to Embodiment 1 of the present invention. (A) is an example of the display unit, and (B) is a trace diagram of the lymphatic system.

[0024] In Test Example 1, a visualization image of the lymphatic system is obtained using the portable biological information observation device of Embodiment 1.

[0025] (Test method) 1) Inject ICG as a visualization agent into the lymphatic vessel to be observed. 2) Operate the first switch on the control panel to select either video or still image. 3) The second switch on the control unit is operated to set the use of near-infrared light emitted from the device's emitter to correspond to the target lymphatic vessel depth. The second switch consists of, for example, three preset switches, from which the use of near-infrared light is selected from strong (mode for imaging the deep lymphatic system), medium (mode for imaging the lymphatic system at a medium depth), and weak (mode for imaging the shallow lymphatic system). By operating the second switch according to the visualization conditions of the area being observed, the wavelength, brightness, and brightness distribution of the near-infrared light emitted from the irradiation device as visualization light are set to correspond to the target lymphatic vessel depth. 4) While irradiating the area under observation with visualization light having a wavelength, brightness, and brightness distribution set by the second switch on the control unit from the irradiation device, the imaging device captures an image of the area under observation and fluorescence as a visualization image of the lymphatic system of the area under observation, and acquires a visualization image signal. 5) Display at least one of the images of the observed area captured by the imaging device and the visualized image of the lymphatic system of the observed area on a display device to confirm the visualized image. 6) If necessary, at least one of the images of the observed area captured by the imaging device and the visualized lymphatic system of the observed area is mirrored to an external system via wireless communication, so that the visualized image can be viewed on the external system's large display.

[0026] (Test results) As shown in the display example of the display unit in Figure 6(A) and the traced diagram of the lymphatic system in Figure 6(B), by irradiating the observed area with near-infrared light (760 nm), the lymphatic system could be visualized by fluorescence, and a visualized image could be obtained. Furthermore, by correlating with mapping data of multiple lymphatic systems obtained in advance, multiple lymphatic systems can be identified and distinguished, and each lymphatic system can be displayed, for example, using a different color. In the example in Figure 6(A), three types of lymphatic systems are displayed in different colors on the display unit. Figure 6(B) is a diagram that more clearly represents the appearance of the lymphatic system by tracing the display example on the actual display unit in Figure 6(A).

[0027] [Method for obtaining multiple lymphatic system mapping data] There are no particular limitations on the method for acquiring mapping data for multiple lymphatic systems, but for example, the following methods can be employed. (1) First, in the first visualization test, the entire lymphatic system pathway is identified by injecting the fluorescent agent into the entire lymphatic system so that the fluorescent agent reaches all lymphatic systems of the subject. (2) Next, as the first stage of the second visualization test, a fluorescent agent is injected into only one location among the lymphatic systems identified in (1) above, to visualize only one lymphatic system from among multiple lymphatic systems, and mapping image data of that first lymphatic system is obtained. (3) Furthermore, as the second stage of the second visualization test, a fluorescent agent is injected into one of the areas within the entire lymphatic system pathway identified in (1) above that was not colored in (2) above, and a differential fluorescence image of only the second lymphatic system from among multiple lymphatic systems is obtained, thereby obtaining mapping image data of that second lymphatic system. (4) Repeat the third and fourth stages in the same manner as in (3) above, until all of the entire lymphatic system pathways identified in (1) above are obtained as mapping image data of individual lymphatic systems.

[0028] [Visualization images of the three-dimensional distribution of the lymphatic system] Figures 6(A) and 6(B) show that the visualization images of the lymphatic system on the actual display unit allow for the distinction and visualization of each lymphatic pathway of multiple lymphatic systems. Furthermore, Figures 6(A) and 6(B) show that the visualization images contain not only planar image information but also information about the three-dimensional distribution of the lymphatic system, such as how the lymphatic systems intersect in the depth direction. In Experimental Example 1, the near-infrared intensity was set to "medium," so the lymphatic system distributed a few centimeters inside the subject's epidermis is clearly visualized. The lymphatic system is distributed not only in the planar direction along the epidermis but also three-dimensionally in the depth direction, and as mentioned above, the depth distribution of the lymphatic system that is visualized can be selected according to the near-infrared intensity. In this way, by adjusting the near-infrared intensity for visualizing the lymphatic system in multiple stages and performing image analysis by superimposing the visualization images at each near-infrared intensity, it is possible to distinguish multiple lymphatic systems and obtain a visualization image of the three-dimensional distribution of each lymphatic system. Furthermore, machine learning, such as deep learning, is effective for image analysis of visualization images of multiple lymphatic systems.

[0029] [Image analysis of lymphatic system visualization images using deep learning 0033] Experimental Example 1 demonstrates the process of actually displaying a visualization image of the lymphatic system of one subject on the display unit, and acquiring, recording, and analyzing the visualization image data. Because there are individual differences in the distribution of the lymphatic system, as mentioned above, in order to acquire multiple standard lymphatic system mapping data, it is necessary to perform image analysis on the lymphatic system visualization image data of multiple subjects with different attributes. In such image processing, it is effective to employ deep learning, which has a proven track record in various image analyses, from the perspective of understanding lymphatic system patterns by learning from a large amount of image data. An example of an image analysis method for lymphatic system visualization images using deep learning is shown below.

[0030] (1) Preprocessing of lymph visualization images To create training data from lymphatic system visualization image data containing multiple lymphatic systems obtained from subjects, image standardization processing is performed as a preprocessing step, including standardization of brightness distribution, standardization of color balance, unification of image size, and expansion of the number of image data by rotating and scaling the images. For this image preprocessing, the scikit-image library is used. This library is a Python library specialized for image processing, and 18 modules are available, enabling image processing such as feature extraction and size determination in addition to Pillow. Furthermore, although not particularly limited, Albumentatios, a machine learning library, is used for data augmentation. This library is an open-source network library and is used for data augmentation.

[0031] (2) CNN learning model We will create a learning model suitable for image recognition of lymphatic system distribution using license-free libraries that are freely available on web pages, etc. The learning model will consider at least the following conditions. While not particularly limited, we used Caffe as a library for creating image recognition models using deep learning. This library is a machine learning library specifically designed for image recognition, offering high-speed operation and GPU support.

[0032] 2a) Obtain one or more types of standard lymphatic system mapping data as a three-dimensional distribution in which multiple lymphatic systems are distinguished, and use it for comparative study with subject-specific information. 2b) The standard lymphatic system mapping data described in 2a) above should be organized in a format that allows for the understanding of hierarchy and diversification levels, such as a tree diagram, and at the very least, a universally common standard model should be constructed for the highest level standardization model. 2c) The teaching data must satisfy at least the following conditions: • The image must be standardized to a predetermined level through preprocessing. The image label information must include, at a minimum, the subject's attribute information, the subject's vital signs at the time of examination, information identifying the examination equipment and conditions, location information of the subject corresponding to the image (information identifying the body part of the subject), and setting information such as the intensity of near-infrared light. Do not use unclear images or poorly labeled data. If you absolutely must use them as training or input data, add accurate information about the data defects as label information, and then flag them as data requiring caution before using them.

[0033] (3) Evaluation of the model The model is evaluated, and its image recognition accuracy is verified. The image data preprocessed in (1) above is classified into training and test sets, and the model trained with the training image data is validated using the test image data with methods such as the holdout method and cross-validation method. (4) If the model evaluation in (3) above verifies that the trained CNN model can achieve the required recognition accuracy, further training of the CNN model will be carried out while using it for actual lymphatic system image recognition, and a standardized and typified model will be constructed as a three-dimensional distribution in which multiple lymphatic systems are distinguished with higher accuracy, and this standardized model will be used for lymphatic system examinations and clinical practice.

[0034] [Embodiment 2] A portable biological information observation device and portable biological information observation system according to Embodiment 2 of the present invention will be described. The description of components common to Figures 1 to 6 will be omitted. Embodiment 1 obtained a visualization image of the lymphatic system, but this embodiment differs from Embodiment 1 in that it obtains visualization images of parts of the observed area other than the lymphatic system (visual images of parts b) to j) below.

[0035] In other words, in this embodiment, the part to be observed is the following, into which a visualization agent has been injected. b) Blood vessels: Blood vessels can be visualized by injecting visualization agents such as ICG. Furthermore, because hemoglobin absorbs light, when light is shone on the area being observed, the resulting shadows can be visualized as blood vessels. In this case, since blood vessels can be visualized without using a visualization agent, it becomes possible to choose whether or not to use a visualization agent. c) Sweat glands can also be visualized using ICG. d) Hair follicles can also be visualized using ICG.

[0036] [Test Example 2] Regarding the acquisition of visualized images of blood vessels As Test Example 2 of this embodiment, an example of acquiring a visualized image of blood vessels is shown. Figure 7 is an example of a visible image including the lymphatic system and blood vessels obtained by the portable biological information observation device of Embodiment 2 of the present invention. (A) is an example of the display unit, and (B) is a trace diagram of the lymphatic system. The specific test method and test results are as follows (1) to (3).

[0037] (1) A visualization agent was injected into the lymphatic system of the subjects, and images of the visualized lymphatic system were recorded by irradiating it with near-infrared light at a wavelength of 760 μm. The white fluorescent area indicated by the long arrow in Figure 7(A) is the lymphatic system. (2) Figure 7(A), which is an image of the actual display unit described in (1) above, shows not only a visualized image of the lymphatic system but also a visualization of blood vessels. In Figure 7(A), these visualized blood vessels are indicated by short arrows. Hemoglobin flowing in blood vessels absorbs near-infrared light even without the use of a visualization agent, so the blood vessels can be visualized because they appear as dark images along the blood vessel pathways. (3) This embodiment is not limited to the method of visualizing blood vessels using the near-infrared absorption effect of hemoglobin as described in (2) above, which does not use a visualizing agent, but also includes methods using a visualizing agent, for example. For example, a visualizing agent containing ICG, etc., can be injected into the blood vessels of a subject to visualize the blood vessels.

[0038] [Test Example 3] Regarding the acquisition of visualization images of subcutaneous tissue other than the lymphatic system and blood vessels, the following items were tested. c) Sweat glands can also be visualized by injecting a visualization agent, as they emit fluorescence when exposed to visualization light. d) When a visualization agent is injected into the hair follicles, they emit fluorescence under the visualization light, making them visible.

[0039] [Test Example 3] Visualization and Image Acquisition Test of Sweat Glands (Test method) Visualization images of sweat glands were obtained in the same manner as in Test Example 1, items 1) to 6). ICG was injected into the sweat glands to be observed as a visualization agent.

[0040] (Test results) Figure 8A is a fluorescence image of a phototherapy agent containing ICG. Figure 8B is a toluidine blue stained image of the region corresponding to Figure 8A. The white area in Figure 8A corresponds to the toluidine blue stained area in Figure 8B (a dark blue area; however, since Figure 6B is a monochrome image converted from the original color image, the toluidine blue stained area is shown as a color close to black or dark). This indicates that this region is the sweat gland cells, which are the target tissue for treatment. This shows that the phototherapy agent injected subcutaneously in the armpit by the phototherapy needle is concentrated in the sweat gland cells, which are the target tissue for treatment.

[0041] The pigment phototherapy needle used in this test example is equipped with multiple needles of different lengths. Using this pigment phototherapy needle, the pigment phototherapy agent can be injected to different subcutaneous depths across the surface area of ​​the epidermis of the armpit corresponding to the target tissue. By distributing and injecting the pigment phototherapy agent to different subcutaneous depths, a portion of the pigment phototherapy agent injected subcutaneously is injected close to the sweat gland area and is concentratedly taken up by the target sweat gland cells directly via the extravascular pathway. In addition, a portion of the pigment phototherapy agent injected subcutaneously is injected into the lymphatic system corresponding to the target sweat gland cells and is concentratedly taken up by the target sweat gland cells via the lymphatic system (see Figure 8B).

[0042] Because ICG is concentrated in the sweat gland cells in this way, when illuminated with visualization light, the sweat gland cells emit fluorescence, as shown in Figure 8A. By imaging this fluorescence of the sweat gland cells with an imaging device, a clear visualization image of the sweat gland cells can be obtained. Obtaining a clear visualization image is useful for sweat gland treatment, such as identifying the treatment area for axillary hyperhidrosis.

[0043] In this example, as described above, a pigment phototherapy needle with multiple needles of different lengths was used as an example. However, this example is not limited to this, and other types of pigment phototherapy needles can be used. In this case as well, the location of the target tissue can be determined, and since the pigment phototherapy agent utilizes the specific retention properties of ICG, the pigment phototherapy agent can be concentrated and taken up by the target tissue. Specifically, in this example, the pigment phototherapy agent has been adjusted in terms of ICG-containing components, concentration, and pH to facilitate uptake by, for example, sweat gland cells, and the injection site into the subcutaneous tissue has been quantitatively determined.

[0044] [Test Example 4] A test example in which a luminescent agent is concentrated in a target tissue (e.g., sweat gland cells). (Test method) The test was conducted under the same conditions as in Test Example 1 described above. In this test example, similar to Test Example 1, the purpose was to treat axillary hyperhidrosis, and the treatment involved thermotherapy with a pigment phototherapy agent incorporated into the target tissue. However, the target of treatment in this test example was more narrowly defined, focusing on the sweat gland region and specifically the acinar cells of the sweat glands.

[0045] The phototherapy agent used was a phototherapy agent containing ICG of the same specifications as that used in Test Example 1. The excitation light was also the same specification alexandrite laser as in Test Example 1, with the same power output and irradiation time. The phototherapy filter applied to the epidermis of the armpit, corresponding to the treatment target tissue, was also the same specification as in Test Example 1. For the phototherapy agent, 0.3 ml of a phototherapy agent containing 0.25 mg / ml ICG of the same specifications as in Test Example 1 was administered by subcutaneous injection.

[0046] While Test Example 1 focused on the area in the armpit where sweat gland cells are concentrated, this test example targets a more specific tissue for treatment, specifically the acinar cells within the sweat gland region, and concentrates the uptake of the pigment phototherapy agent there.

[0047] By injecting a phototherapy agent subcutaneously through the epidermis corresponding to the target tissue using a phototherapy needle, the injected phototherapy agent is concentratedly taken up by the target tissue, the sweat gland cells, via the lymphatic system and extravascular drainage pathways corresponding to the target sweat gland cells. In this test example, although there is no particular limitation to the phototherapy needle, a specification with multiple needles of different lengths as described above was used to concentrate the uptake of the phototherapy agent into the target sweat gland acinar cells via both the lymphatic system and extravascular drainage pathways.

[0048] (Test results) Figure 9 shows a fluorescence image of sweat gland cells when a dye phototherapy agent according to Embodiment 2 of the present invention is added and irradiated with light, and Figure 10 shows a toluidine blue stained image of the sweat gland cells from Figure 9.

[0049] Figure 9 is an image taken from the outside of the epidermis with a camera, showing the fluorescence emitted by tissue that has concentratedly absorbed the pigment phototherapy agent. Figure 10 is an image stained with toluidine blue, which is the target tissue for treatment, and the sweat gland region in the same area as in Figure 9 is shown as dark blue. However, as with Figure 8B, the toluidine blue stained area is a dark blue area in a color image, but since Figure 10 is a monochrome image converted from the original color image, the toluidine blue stained area is shown as a color close to black or a dark color.

[0050] In Figure 10, the area enclosed by the white line (the area stained in a dark color, or dark blue in the case of a color photograph) represents the distribution area of ​​sweat gland cells, which are the target tissue. Toluidine blue is also distributed in areas other than sweat gland cells, but here we will focus on area A enclosed by the white line and area B enclosed by the black line in Figure 10.

[0051] In Figure 10, within region A enclosed by the white line, the dark blue areas represent sweat gland mammary cells. Region B enclosed by the black line represents the sweat gland ducts. In Figure 9, tissue that has concentratedly absorbed the pigment phototherapy agent fluoresces and appears white in the image. Region A enclosed by the white line in Figure 9 and region A enclosed by the white line in Figure 10 correspond to each other in terms of their relative positions, and region B enclosed by the black line in Figure 9 and region B enclosed by the black line in Figure 10 correspond to each other in terms of their relative positions.

[0052] In Figure 10, the degree of uptake of the phototherapy agent into the tissue can be determined from the fluorescence intensity (intensity of the white glowing areas). Here, the degree of uptake is evaluated on a four-point scale: +2 (very high uptake), +1 (high uptake), -1 (low uptake), and -2 (very low uptake). The degree of uptake of the phototherapy agent into the acinar cells of the sweat glands in region A, enclosed by the white lines in Figure 10, was evaluated as +2 (very high uptake). The degree of uptake of the phototherapy agent into the sweat gland ducts in region B, enclosed by the black lines in Figure 10, was evaluated as -1 (low uptake). In addition, in regions other than region A and region B enclosed by the black lines in Figure 10, the phototherapy agent is taken up to some extent by the background cells, but the uptake is very weak compared to the area of ​​acinar cells, the target tissue of the sweat glands in region A enclosed by the white lines.

[0053] The pigment phototherapy needle used in this test example has multiple injection holes along its length, allowing the pigment phototherapy agent to be injected over a wide area distributed from the epidermis to the depths. Therefore, by using this pigment phototherapy needle, the pigment phototherapy agent is distributed and injected over a wide area to different depths in the subcutaneous tissue, and the pigment phototherapy agent injected subcutaneously is concentratedly taken up directly by the sweat gland acinar cells near the injection holes via extravascular fluid pathways. In addition, a portion of the pigment phototherapy agent injected subcutaneously is injected into the lymphatic system corresponding to the target sweat gland acinar cells and is concentratedly taken up by the target sweat gland acinar cells via the lymphatic system. Because the pigment phototherapy agent of this embodiment utilizes the specific retention properties of ICG, it is hardly taken up by tissues that are not normally targeted for treatment, such as the sweat gland ducts in region B enclosed by the black line in Figure 10.

[0054] As can be seen from Figure 9, the visualization agent is incorporated only in the region where the target tissue, the acinar cells of the sweat glands, are present. As a result, when visualization light is irradiated, only the target tissue emits fluorescence, and by imaging this fluorescence of the target tissue with an imaging device, the target tissue can be clearly visualized. The portable biological information observation device of this embodiment is extremely useful for identifying the treatment area during sweat gland treatment, such as thermotherapy for axillary hyperhidrosis, by clearly visualizing the target tissue, such as the acinar cells of the sweat glands.

[0055] In this example, the dye phototherapy needle shown corresponds to that described in Figure 10 below. However, this example is not limited to this, and other types of dye phototherapy needles can be used. In this case as well, by determining the location of the target tissue and utilizing the specific retention properties of ICG, the dye phototherapy agent can be concentrated and taken up by the target tissue. Specifically, in this example, the dye phototherapy agent, for example, has its ICG-containing components, concentration, and pH adjusted to be easily taken up by sweat gland cells, and the injection site into the subcutaneous tissue is quantitatively determined.

[0056] In this example, as described above, a pigment phototherapy needle with multiple needles of different lengths was used as an example. However, this example is not limited to this, and other types of pigment phototherapy needles can be used. In this case as well, the location of the target tissue can be determined, and since the pigment phototherapy agent utilizes the specific retention properties of ICG, the pigment phototherapy agent can be concentrated and taken up by the target tissue. Specifically, in this example, the pigment phototherapy agent has been adjusted in terms of ICG-containing components, concentration, and pH to facilitate uptake by, for example, sweat gland cells, and the injection site into the subcutaneous tissue has been quantitatively determined.

[0057] [Test Example 5] Visualization and Image Acquisition Test for Hair Follicles (Test method) Visualization images of hair follicle cells were obtained in the same manner as in Test Example 1, items 1) to 6). ICG was injected into the hair follicles to be observed as a visualization agent. In this test example, the ICG concentration was kept constant at 0.25 g / ml, and the test was conducted using abdominal hair follicles.

[0058] (Test results) Figure 11 shows stained hair follicle cells with a pigment phototherapy agent containing ICG. Figure 11A is a wide-area image, and Figure 11B is a magnified portion of Figure 11A. The arrows in Figure 11A indicate the epidermis. The arrows in Figure 11B indicate hair follicle cells. In Figures 11A and 11B, the dark areas are those where ICG has been taken up and stained. It can be seen that the pigment phototherapy agent injected subcutaneously in the armpit using a pigment phototherapy needle is concentrated in the hair follicle cells, which are the target tissue for treatment. When visualization light is shone on the areas where ICG has been taken up, the ICG fluoresces. By imaging the hair follicle cells that have been taken up by ICG and are fluorescing in this way using an imaging device, a clear visualization image can be obtained.

[0059] The pigment phototherapy needle used in this test example is equipped with numerous needles of different lengths. Using this pigment phototherapy needle, the pigment phototherapy agent can be injected to different subcutaneous depths across a surface area of ​​the epidermis in the armpit corresponding to the target tissue. By distributing and injecting the pigment phototherapy agent to different subcutaneous depths, a portion of the pigment phototherapy agent injected subcutaneously is injected close to the hair follicle region and is concentratedly taken up by the target hair follicle cells via the extravascular pathway. In addition, a portion of the pigment phototherapy agent injected subcutaneously is injected into the lymphatic system corresponding to the target hair follicle cells and is concentratedly taken up by the target hair follicle cells via the lymphatic system (see Figure 11B).

[0060] Because ICG is concentrated in the hair follicle cells in this way, when illuminated with visualization light, the hair follicle cells emit fluorescence, as shown in Figure 11A. By imaging this fluorescence of the hair follicle cells with an imaging device, a clear visualization image of the hair follicle cells can be obtained. Obtaining a clear visualization image is useful for identifying the treatment area in hair follicle treatment.

[0061] In this example, as described above, a pigment phototherapy needle with multiple needles of different lengths was used as an example. However, this example is not limited to this, and other types of pigment phototherapy needles can be used. In this case as well, the location of the target tissue can be determined, and since the pigment phototherapy agent utilizes the specific retention properties of ICG, the pigment phototherapy agent can be concentrated and taken up by the target tissue. Specifically, in this example, the pigment phototherapy agent has been adjusted in terms of ICG-containing components, concentration, and pH to facilitate uptake by, for example, sweat gland cells, and the injection site into the subcutaneous tissue has been quantitatively determined.

[0062] <Variation> The above embodiments exemplify portable biological information observation devices and portable biological information observation systems that embody the technical concept of the present invention. The present invention is not limited to these embodiments, and can be equally applied to other embodiments, such as modifications to these embodiments or combinations of the technologies described in these embodiments.

[0063] For example, near-infrared light was used as an example of visualization light, but this embodiment is not limited to this. For example, the brightness, wavelength, and brightness distribution of the visualization light can be set according to the specifications of the visualization agent, such as red light or laser light. [Explanation of Symbols]

[0064] 10…Portable biological information observation device 20…Irradiation device 30…Insulating film for display devices 40…Imaging device 50…Control device 60...Gripping part 70…External systems

Claims

1. A portable biological information observation system comprising at least an irradiation device that irradiates the area to be observed with photon energy, an imaging device that captures the area to be observed visualized by the irradiation of the visualization light from the irradiation device as a visualization image and generates a visualization image signal of the area to be observed, a display device that displays the visualization image signal generated by the imaging device, and an operation unit, The system comprises at least the irradiation device, the imaging device, and the display device, The main body portion has at least one pair of opposing surfaces, A photon energy emission unit of the irradiation device and an imaging unit of the imaging device are provided on one of the opposing surfaces. A display unit for the display device is provided on the other surface of the opposing surface. A portable biological information observation device comprising an illumination control unit that controls the visualization light of the illumination device, wherein the illumination control unit controls the illumination device that irradiates the photon energy to have a wavelength, brightness, and brightness distribution set according to the visualization conditions of the observed part, based on a command from the operation unit.

2. Furthermore, a gripping part is detachably attached to the main body. The gripping portion is formed in an elongated shape and has a grip portion at the tip. The grip portion is provided with a protruding portion that is positioned in a direction intersecting the grip portion. The portable biological information observation device according to claim 1, characterized in that the operating part is provided near the projection of the protruding part or the grip part.

3. The portable biological information observation device according to claim 1, characterized in that the operating unit includes at least one of the following switches: a preset switch for setting the wavelength, brightness, and brightness distribution of the visualization light emitted from the irradiation device, and an image switching switch for switching between video and still images.

4. The portable biological information observation device according to claim 1, characterized in that the region in which the plurality of LEDs are arranged is distributed on one of the opposing surfaces, excluding the outer frame portion of one of the opposing surfaces and the imaging unit.

5. The observed part is, a) Lymphatic system b) Blood vessels c) sweat glands d) Hair follicles At least one of the following: The irradiation device irradiates the area to be observed into which the visualization agent has been injected with visualization light. The visualization light is irradiated onto the part to be observed into which the visualization agent has been injected. The portable biological information observation device according to claim 1, characterized in that the imaging device captures a visualized image of the observed portion visualized by the illumination device, and generates a visualized image signal of the observed portion.

6. The portable biological information observation device according to claim 5, characterized in that the visualization image signal includes, in addition to the imaging signal of the visualization image, an image recognition output signal obtained by image recognition processing of the visualization image signal by an image recognition unit having a learning function.

7. The part to be observed is injected with the visualization agent. The imaging device captures a visualization image of the area to be observed irradiated by the irradiation device and generates an imaging signal. The portable biological information observation system according to claim 5, characterized in that the display device displays at least one of the imaging signal of the visualization image and the image corresponding to the image recognition output signal.

8. The visualization light used includes photon energy comprising at least one of visible light, infrared light, near-infrared light, ultraviolet light, and laser light. The portable biological information observation system according to claim 1, characterized in that, depending on the visualization light and the part to be observed, it is possible to select to use the visualization agent comprising at least one of ICG, patent blue, indigo carmine, lipiodol, isosulfan blue, iopamilon, heptamethyl lemmycete, protoproferin, and organic anion transporter (OATP), or not to use the visualization agent.

9. The observed portion is injected with ICG as the visualization agent. The irradiation device irradiates the observed portion with light containing at least one of infrared, near-infrared, or red light as the visualization light. The portable biological information observation device according to claim 5, characterized in that it captures a visualization image including fluorescence in the observed part irradiated with the visualization light by the irradiation device and generates an imaging signal.

10. moreover, (1) By communicating with an external system, the visible image is displayed on an external magnifying monitor. (2) The main unit is equipped with a detachable battery and a function to switch between power supply from the battery and power supply from the power cord. (3) The gripping part is detachably connected to the main body, 3a) It shall be a stationary type. 3b) Secure the device to the mounting stand, ceiling, headband, etc. 3c) To secure by suspending from the ceiling, and, 3d) Attach a mounting bracket instead of the gripping part. The portable biological information observation device according to claim 1, characterized in that the main body is attached by at least one of the following.

11. The portable biological information observation device according to claim 1, characterized in that the lighting control unit controls the plurality of LEDs to have wavelengths, luminances, and luminance distributions set according to multi-stage visualization conditions in the depth direction based on commands from the operation unit, thereby capturing multi-stage visualization images in the depth direction with the imaging device, and generating a 3D visualization image by synthesizing these multi-stage visualization images in the depth direction.

12. A portable biometric information device according to claim 1, A computing device comprising at least a display device with a mirroring function and an image recognition device with a learning function having the image recognition unit, A portable biological information observation system comprising: The control device is The image capture signal of the visualization image and the image corresponding to at least one of the image recognition output signals generated by the image recognition unit are communicated with the computing device. A portable biological information observation system characterized by displaying information on at least one of the display device and the display device with mirroring function.

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