JP2022155297A - Disease monitoring system - Google Patents

Abstract

To provide a disease monitoring system allowing a subject to easily perform in daily life, sampling of a test specimen and measurement of a marker for disease risk diagnosis for diagnosing a disease possibility of being included in the test specimen.SOLUTION: A disease monitoring system 2 comprises a bottom case 22, an upper case 21 including a placement part 211, an immunochromatographic reaction chip 3 having a puncture needle 33, a reaction chip holder 24, an energizing member 25, a lock release part 26, a light irradiation device 41, and a photodetector 42. The placement part 211 includes a puncture needle hole through which a tip of the puncture needle 33 can pass. When the lock release part 26 releases the lock, the immunochromatographic reaction chip 3 receives energizing force from the energizing member 25 and moves toward the upper case 21. The puncture needle 33 is punctured into a living body through the puncture needle hole to sample a test specimen, and includes a stopper 34 for stopping the movement of the immunochromatographic reaction chip 3 and closing the puncture needle.SELECTED DRAWING: Figure 3

Description

The present invention relates to a disease monitoring system that measures disease risk diagnostic markers that may be contained in test specimens.

For example, as in the immunochromatographic test strip disclosed in Patent Document 1, disease risk diagnostic markers that may be contained in test specimens such as blood, urine, stool, nasal discharge and saliva are detected by antigen-antibody reaction. There are immunochromatographic reaction chips for measurement or detection. Such immunochromatographic reaction chips are often used in specialized institutions such as medical institutions and research institutions.

On the other hand, a person to be monitored, i.e., a subject, can easily collect test specimens in their daily lives without going to a medical institution, and carry out disease risk diagnostic markers that may be contained in the test specimens. It is desired to provide a system that can measure and easily recognize test results such as disease risk levels.

Patent Document 2 discloses a plasma or serum separator that can quickly and easily separate and recover plasma or serum from a whole blood sample in blood tests at medical sites that require occasional and immediacy such as emergency tests and home tests, and A method for collecting plasma or serum is disclosed. However, the plasma or serum separator and the method for collecting plasma or serum described in Patent Document 2 include a step of causing bleeding by inserting a blood collection needle into a blood collecting part, and after bleeding, applying the plasma or serum separator to the bleeding site. a step of collecting blood by contacting the blood introduction portion or the mesh member of the blood introduction portion and supplying the blood from the blood introduction portion; and collecting plasma or serum with a metering pipette, capillary tube, or the like. Therefore, the plasma or serum separator and the method for collecting plasma or serum described in Patent Document 2 allow a person to be monitored, i. There is room for improvement in terms of sampling.

Japanese Patent Application Laid-Open No. 2020-63911 JP 2008-275627 A

The present invention has been made in order to solve the above-mentioned problems, and a subject can easily collect a test sample and diagnose a disease risk that may be contained in the test sample in his/her daily life. It is an object of the present invention to provide a disease monitoring system capable of measuring markers.

The above-described problem is a disease monitoring system that collects test specimens and measures disease risk diagnostic markers that may be contained in the test specimens, comprising: a bottom case; and an upper case having a placing portion on which the test sample is placed, and a puncture needle that is housed between the bottom case and the upper case and is punctured into the living body, and collects the test specimen to obtain the disease risk. An immunochromatographic reaction chip for detecting a diagnostic marker, and a reaction having a lock mechanism provided in at least one of the bottom case and the upper case, holding the immunochromatographic reaction chip, and locking the immunochromatographic reaction chip. an urging member provided in the bottom case for urging the immunochromatographic reaction chip toward the upper case; and a locking mechanism provided in at least one of the bottom case and the upper case. a light irradiation device provided in either the bottom case or the upper case for irradiating measurement light toward the immunochromatographic reaction chip; the bottom case and the upper case; and a photodetector for detecting reflection measurement light irradiated from the light irradiation device and reflected by the immunochromatography reaction chip or transmission measurement light transmitted through the immunochromatography reaction chip, The placement section has a puncture needle hole through which the tip of the puncture needle can pass, and the immunochromatographic reaction chip receives a biasing force from the biasing member when the unlocking section unlocks the lock mechanism. and moves toward the upper case, and the puncture needle pierces the living body through the puncture needle hole as the immunochromatography reaction chip moves to collect the test sample. It is solved by a disease monitoring system according to the invention.

According to the disease monitoring system of the present invention, the immunochromatographic reaction chip is housed between the bottom case and the upper case. In addition, the immunochromatographic reaction chip has a puncture needle that is punctured into a living body, and a test sample is collected by the puncture needle to detect disease risk diagnostic markers. The upper case has a placement portion on which a living body is placed. The placement section has a puncture needle hole through which the tip of the puncture needle of the immunochromatographic reaction chip can pass. When the subject operates the unlocking part to unlock the lock mechanism provided in the reaction chip holder, the immunochromatographic reaction chip receives the biasing force from the biasing member and moves toward the upper case. Then, as the immunochromatographic reaction chip moves, the puncture needle is pierced into the living body through the puncture needle hole, and a test specimen is collected. As a result, the subject can easily collect a test sample in their daily life using the disease monitoring system according to the present invention.

In the disease monitoring system according to the present invention, preferably, the puncture needle has a stopper that stops the movement of the immunochromatographic reaction chip and closes the puncture needle hole in a state in which the puncture needle is punctured into the living body. characterized by having

According to the disease monitoring system of the present invention, the puncture needle has a stopper. The stopper stops movement of the immunochromatographic reaction chip while the puncture needle is pierced into the living body. Further, the stopper closes the puncture needle hole in a state in which the puncture needle is punctured into the living body. Therefore, the stopper can prevent stray light from entering the space housing the immunochromatographic reaction chip through the puncture needle hole. Therefore, the photodetector can detect, with higher accuracy, the reflection measurement light emitted from the light irradiation device and reflected by the immunochromatographic reaction chip or the transmission measurement light transmitted through the immunochromatographic reaction chip. As a result, the subject can use the disease monitoring system according to the present invention to easily measure the disease risk diagnostic marker that may be contained in the test sample in daily life.

The disease monitoring system according to the present invention is preferably characterized in that the inner surface of the bottom case and the inner surface of the upper case are coated with a light-absorbing material.

According to the disease monitoring system of the present invention, since the inner surface of the bottom case and the inner surface of the upper case are coated with a light-absorbing material, the detection of the reflection measurement light or the transmission measurement light by the photodetector is difficult. Stability can be improved. In addition, it is possible to prevent the subject from visually recognizing the puncture needle through the puncture needle hole.

The disease monitoring system according to the present invention is preferably characterized in that the unlocking portion is provided on at least one side surface of the bottom case and the upper case.

According to the disease monitoring system according to the present invention, a subject places a living body such as a finger on the placement portion provided in the upper case, and the patient is placed on at least one of the side surfaces of the bottom case and the upper case. The locking mechanism can be unlocked by operating the unlocking portion. Therefore, the subject can unlock the lock mechanism with one hand, for example, and can puncture a living body such as a finger placed on the placement section with the puncture needle. As a result, the subject can use the disease monitoring system according to the present invention to easily collect test specimens and detect disease risk diagnostic markers that may be contained in the test specimens in their daily lives. Measurements and can be made.

In the disease monitoring system according to the present invention, preferably, at least one of progress and results of examination of the marker for diagnosing disease risk is based on the reflected measurement light or the transmission measurement light detected by the photodetector. is further provided with a control unit that executes display processing for displaying on the display device.

According to the disease monitoring system of the present invention, the control unit displays at least one of the examination progress and the examination result of the disease risk diagnostic marker based on the reflected measurement light or transmission measurement light detected by the photodetector. Execute display processing for displaying on a display device. Therefore, by checking the display device, the subject can easily recognize at least one of the examination progress and the examination result of the disease risk diagnostic marker.

In the disease monitoring system according to the present invention, preferably, at least one of progress and results of examination of the marker for diagnosing disease risk is based on the reflected measurement light or the transmission measurement light detected by the photodetector. is further provided with a projection device for projecting and displaying the .

According to the disease monitoring system of the present invention, the projection device displays at least one of the examination progress and the examination result of the disease risk diagnostic marker based on the reflected measurement light or transmission measurement light detected by the photodetector. , for example, can be projected and displayed on a place such as a mirror surface or a wall surface where the subject can easily visually recognize the image. Therefore, the subject can easily perceive at least one of the examination progress and the examination result of the disease risk diagnostic markers by checking the display projected on a mirror surface, wall surface, or the like.

In the disease monitoring system according to the present invention, preferably, the test specimen is blood of the living body, the light irradiation device is a first light irradiation device, and the photodetector is a first photodetector. The immunochromatographic reaction chip is provided with the puncture needle at one end, and is formed of a porous material and has a first layer that separates the blood into blood cells and plasma components, and the first layer a second layer connected to the other end and made of a porous material into which the plasma components separated by the first layer are transferred. The disease monitoring system according to the present invention is preferably provided at a portion of either the bottom case or the upper case corresponding to the other end of the first layer, and the other end of the first layer. a second light irradiation device for irradiating measurement light toward an end; and a portion of either the bottom case or the upper case that corresponds to the other end of the first layer. a second photodetector for detecting reflected measurement light emitted from a light irradiation device and reflected at the other end of the first layer or transmission measurement light transmitted through the other end of the first layer; When the second photodetector detects that the blood has reached the other end of the first layer based on the reflection measurement light or the transmission measurement light, the living body mounted on the mounting section and a guide portion for guiding the separation from the placement portion.

According to the disease monitoring system of the present invention, the immunochromatographic reaction chip has the first layer and the second layer. A puncture needle is provided at one end of the first layer. The first layer is formed of a porous material and separates the blood into blood cells and plasma components. The second layer is connected to the other end of the first layer and made of a porous material. Plasma components separated by the first layer migrate from the first layer to the second layer. The disease monitoring system further includes a second light irradiation device different from the first light irradiation device, a second photodetector different from the first photodetector, and a guiding section. The second light irradiation device is provided at the other end of the first layer, that is, a portion corresponding to the connection portion between the first layer and the second layer, and irradiates the measurement light toward the other end of the first layer. do. The second photodetector is provided at the other end of the first layer, that is, the portion corresponding to the connection portion between the first layer and the second layer, and is irradiated from the second light irradiation device to detect the other end of the first layer. Reflected measurement light reflected at the first layer or transmitted measurement light transmitted through the other end of the first layer is detected. Then, when the second photodetector detects that the blood has reached the other end of the first layer based on the reflected measurement light or the transmission measurement light, the guide section detects the presence of the living body placed on the placement section. It guides the separation from the placing section. Therefore, the subject can easily recognize that the blood collection as the test specimen is completed and the living body placed on the placement section can be removed from the placement section.

In the disease monitoring system according to the present invention, preferably, the first layer separates the blood cell component contained in the blood from the plasma component and promotes migration of the plasma component toward the second layer. It is characterized by having a transition promoting structure.

According to the disease monitoring system according to the present invention, the migration-promoting structure reliably separates blood cell components and plasma components contained in blood by the first layer, and transfers the separated plasma components from the first layer to the second layer. It can be transferred to the layer more reliably. As a result, the disease monitoring system according to the present invention can more accurately detect disease risk diagnostic markers that may be contained in blood as a test specimen.

In the disease monitoring system according to the present invention, preferably, the migration promoting structure is such that the porosity of the porous material of the first layer is from the one end of the first layer to the other of the first layer. It has a structure that decreases towards the end.

According to the disease monitoring system of the present invention, the migration-promoting structure has a simpler structure, so that the plasma components separated by the first layer can more reliably migrate from the first layer to the second layer. As a result, the disease monitoring system according to the present invention can detect disease risk diagnostic markers that may be contained in blood as a test sample with higher accuracy due to the simpler structure of the transition promoting structure.

In the disease monitoring system according to the present invention, preferably, the puncture needle is made of a porous material, and the porous material contains a freeze-dried anticoagulant.

According to the disease monitoring system of the present invention, the freeze-dried anticoagulant is encapsulated in the porous material forming the puncture needle. Therefore, the anticoagulant dissolves in the blood infiltrating the puncture needle, and can suppress coagulation of the blood in the porous material of the puncture needle. As a result, the puncture needle can more reliably transfer blood that has permeated the puncture needle from the puncture needle to the first layer.

According to the present invention, a disease in which a subject can easily collect a test sample and measure a disease risk diagnostic marker that may be contained in the test sample in daily life. A monitoring system can be provided.

BRIEF DESCRIPTION OF THE DRAWINGS It is a perspective view showing the outline|summary of the disease monitoring system which concerns on embodiment of this invention. It is a top view showing the disease monitoring system concerning this embodiment. It is a side view showing the disease monitoring system concerning this embodiment. 1 is a plan view showing the immunochromatographic reaction chip of this embodiment. FIG. 1 is a block diagram showing the main configuration of a disease monitoring system according to this embodiment; FIG.

Preferred embodiments of the invention are described in detail below with reference to the drawings.
Since the embodiments described below are preferred specific examples of the present invention, various technically preferable limitations are applied. Unless otherwise stated, the invention is not limited to these modes. Further, in each drawing, the same constituent elements are denoted by the same reference numerals, and detailed description thereof will be omitted as appropriate.

FIG. 1 is a perspective view showing an outline of a disease monitoring system according to an embodiment of the invention.
FIG. 2 is a plan view showing the disease monitoring system according to this embodiment.
FIG. 3 is a side view showing the disease monitoring system according to this embodiment.

The disease monitoring system 2 according to the present embodiment collects test specimens such as blood, urine, stool, nasal discharge, and saliva, and measures disease risk diagnostic markers that may be contained in the test specimens. In the description of this embodiment, the case where the test sample is blood will be taken as an example. Note that the test specimen is not limited to blood. Disease risk diagnostic markers measured by the disease monitoring system 2 according to this embodiment include, for example, tumor markers. Examples of tumor markers include proteins, enzymes, and hormones contained in blood. 439, SLX, STN, βHCG, NSF, ProGRP, PIVKA-II, ElastaseI and the like. The disease risk diagnostic markers are not limited to tumor markers. For example, the disease risk diagnostic marker may be a virus or a physiologically active substance such as a protein generally measured using an antigen-antibody reaction.

As shown in FIGS. 1 to 3, the disease monitoring system 2 includes an upper case 21, a bottom case 22, an immunochromatographic reaction chip 3, a reaction chip holder 24, a biasing member 25, and a lock release portion. 26 , a first light irradiation device 41 and a first photodetector 42 . The first light irradiation device 41 of this embodiment is an example of the "light irradiation device" of the present invention. The first photodetector 42 of this embodiment is an example of the "photodetector" of the present invention.

The upper case 21 and the bottom case 22 function as a housing or main body of the disease monitoring system 2, and are made of, for example, thermoplastic resin having a predetermined strength. The thermoplastic resin forming the upper case 21 and the bottom case 22 is a thermoplastic resin that can be sterilized and sterilized by wiping or spraying with ethyl alcohol solution before and after each inspection, such as polyether such as polyphenylene oxide. polyesters such as polyethylene terephthalate and polybutylene terephthalate; polyacetal; acrylic resins such as polymethyl methacrylate; styrene resins such as ABS resin and high impact styrene; polyolefin resins such as poly-2-methylpentene and polypropylene; An opaque or colored synthetic resin selected from at least one of the above. Preferably, by forming the upper case 21 and the bottom case 22 from a synthetic resin containing about 1 to 2.5% by weight of a silver zirconium phosphate compound in these resins, the antibacterial properties, strength, impact resistance, etc. can be obtained. An upper case 21 and a bottom case 22 can be formed. The inner surface of the upper case 21 and the inner surface of the bottom case 22 are coated with a light-absorbing material. Materials having light absorption properties include, for example, Vantablack. For example, as indicated by an arrow A1 shown in FIG. 3, the upper case 21 is connected to the bottom case 22 at a hinge portion 23 and pivotally supported with respect to the bottom case 22 so as to be rotatable.

The upper case 21 has a mounting portion 211 on which the living body of the person to be monitored, that is, the subject is mounted. Examples of the subject's living body include the subject's finger and the like. As shown in FIG. 1, the placing portion 211 has a groove shape that allows the subject to easily place his or her finger. For example, the subject can easily hold the upper case 21 with the palm of the hand while easily placing the middle finger or the index finger on the placing portion 211 .

As shown in FIGS. 1 and 2, the placement section 211 has a puncture needle hole 212 through which the distal end portion 331 (see FIG. 3) of the puncture needle 33 provided in the immunochromatographic reaction chip 3 can pass. The puncture needle hole 212 is provided at one end of the mounting portion 211 and substantially in the center of the upper case 21 . Accordingly, for example, when the subject places the middle finger or the index finger on the placement section 211, the puncture needle 33 is punctured into the living body on the distal end side of the first joint of the finger. The details of puncturing with the puncture needle 33 will be described later.

The immunochromatographic reaction chip 3 is accommodated between the upper case 21 and the bottom case 22 and held by the reaction chip holder 24 . A reaction chip holder 24 is provided in at least one of the upper case 21 and the bottom case 22 . As shown in FIG. 3, the reaction tip holder 24 has a protrusion 242 . On the other hand, the immunochromatographic reaction chip 3 has a notch 324 . When the immunochromatographic reaction chip 3 is attached to the reaction chip holder 24, the protrusion 242 of the reaction chip holder 24 and the notch 324 of the immunochromatographic reaction chip 3 are fitted to each other. As a result, the immunochromatographic reaction chip 3 is fixed to the reaction chip holder 24 . As long as the immunochromatographic reaction chip 3 is fixed to the reaction chip holder 24, the reaction chip holder 24 may have a notch, and the immunochromatographic reaction chip 3 may have a protrusion. good.

The immunochromatographic reaction chip 3 is detachable from the reaction chip holder 24 . Therefore, the subject rotates the upper case 21 with respect to the bottom case 22 to open the main body of the disease monitoring system 2, and inserts the immunochromatographic reaction chip 3 fixed to the reaction chip holder 24 into another new immunochromatographic reaction. can be easily replaced with the tip 3 for The immunochromatographic reaction chip 3 has a puncture needle 33 to be punctured into a living body, and collects blood as a test sample from the living body placed on the placement section 211 to detect disease risk diagnostic markers.

As shown in FIG. 3, puncture needle 33 has stopper 34 . The stopper 34 may be formed integrally with the puncture needle 33 or may be provided on the puncture needle 33 as a separate body from the puncture needle 33 . Details of the stopper 34 will be described later.

As described above, the reaction chip holder 24 holds the immunochromatographic reaction chip 3 . In addition, as shown in FIG. 3, the reaction tip holder 24 has a lock mechanism 241 . The lock mechanism 241 locks the immunochromatographic reaction chip 3 . That is, the lock mechanism 241 suppresses the movement of the immunochromatographic reaction chip 3 .

The biasing member 25 is an elastic member such as a spring or rubber, and is provided on the bottom case 22 . The biasing member 25 biases the immunochromatographic reaction chip 3 held by the reaction chip holder 24 toward the upper case 21 as indicated by an arrow A2 shown in FIG.

As shown in FIGS. 1 to 3, the unlocking portion 26 is provided on the side surface 213 of the upper case 21. As shown in FIGS. The unlocking portion 26 may be provided on the side surface 223 of the bottom case 22 .

The unlocking unit 26 unlocks the lock mechanism 241 when receiving an operation such as pressing from the subject. For example, when the subject places the middle finger or index finger of the right hand on the placement section 211, the subject can operate the unlocking section 26 with the thumb of the right hand. Alternatively, when the subject places the middle finger or the index finger of the left hand on the placement section 211, the subject can operate the unlocking section 26 using the little finger of the left hand.

When the subject operates the unlocking unit 26 and the unlocking unit 26 unlocks the lock mechanism 241, the immunochromatographic reaction chip 3 is unlocked and attached as indicated by the arrow A2 shown in FIG. It moves toward the upper case 21 by receiving the biasing force from the biasing member 25 . For example, the immunochromatographic reaction chip 3 receives a biasing force from the biasing member 25 and rotates about the reaction chip holder 24 as a center.

The first light irradiation device 41 is provided in either the upper case 21 or the bottom case 22 and irradiates the immunochromatographic reaction chip 3 with measurement light. In the disease monitoring system 2 shown in FIG. 3 , the first light irradiation device 41 is provided in the upper case 21 . The first light irradiation device 41 is, for example, a light emitting diode (LED: Light Emitting Diode), and irradiates light of a predetermined wavelength.

The first photodetector 42 is provided on either the upper case 21 or the bottom case 22 and detects light emitted from the first light irradiation device 41 . In the disease monitoring system 2 shown in FIG. 3 , the first photodetector 42 is provided on the bottom case 22 . The first photodetector 42 is, for example, an array photodiode. For example, the first photodetector 42 detects reflection measurement light that is emitted from the first light irradiation device 41 and reflected by the immunochromatographic reaction chip 3 . Alternatively, the first photodetector 42 detects the transmitted measurement light that is irradiated from the first light irradiation device 41 and transmitted through the immunochromatographic reaction chip 3 . In the disease monitoring system 2 shown in FIG. 3 , the first photodetector 42 detects the transmission measurement light that is irradiated from the first light irradiation device 41 and transmitted through the immunochromatographic reaction chip 3 . The first photodetector 42 is provided in the upper case 21 in the vicinity of the first light irradiation device 41 when detecting the reflection measurement light irradiated from the first light irradiation device 41 and reflected by the immunochromatographic reaction chip 3. .

Next, the immunochromatographic reaction chip 3 of this embodiment will be described with reference to the drawings.
FIG. 4 is a plan view showing the immunochromatographic reaction chip of this embodiment.
The immunochromatographic reaction chip 3 of this embodiment has a first layer 31 , a second layer 32 , a puncture needle 33 and a stopper 34 .

The puncture needle 33 is provided at one end 311 of the first layer 31 and is made of a porous material. Porous materials forming the puncture needle 33 include, for example, paper, cellulose mixtures, nitrocellulose, polyesters, acrylonitrile copolymers, glass, and non-woven fibers such as rayon. Other examples include plastic materials such as polyethylene and polypropylene, and porous materials such as ceramics.

As indicated by the arrow A3 shown in FIG. 3, the blood collected (that is, infiltrated) into the puncture needle 33 by the puncture needle 33 being punctured into the living body migrates from the puncture needle 33 to the first layer 31 due to capillary action. do. Here, the puncture needle 33 includes a freeze-dried anticoagulant in a porous material. Therefore, the anticoagulant dissolves in the blood infiltrating the puncture needle 33 and can suppress the blood from coagulating in the porous material of the puncture needle 33 . As a result, the puncture needle 33 can more reliably transfer blood that has permeated the puncture needle 33 from the puncture needle 33 to the first layer 31 .

The first layer 31 is made of a material appropriately selected from porous materials capable of generating capillary action, and functions as a blood cell component separation layer. Examples of the porous material forming the first layer 31 include the non-woven fibers and porous bodies described above with regard to the puncture needle 33 . The first layer 31 separates blood into blood cells and plasma components, and causes only the plasma components to migrate from the first layer 31 to the second layer 32 by capillary action as indicated by arrow A4 shown in FIG. On the other hand, blood cells separated by the first layer 31 are captured by the first layer 31 . The first layer 31 has a migration-promoting structure that promotes separation of plasma components from the first layer 31 to the second layer 32 and migration of the plasma components. That is, the migration-promoting structure separates blood cell components and plasma components contained in blood, and promotes migration of the plasma components from the first layer 31 to the second layer 32 . Specifically, in the transition promoting structure of the first layer 31, the porosity of the porous material of the first layer 31 is directed from one end 311 of the first layer 31 to the other end 312 of the first layer 31. It has the characteristics of decreasing as Thereby, the migration promoting structure of the first layer 31 can more reliably migrate the plasma components separated by the first layer 31 from the first layer 31 to the second layer 32 with a simpler structure.

The second layer 32 is connected to the other end 312 of the first layer 31 . The second layer 32 is made of a porous material and functions as a reaction layer for immunochromatography. Examples of the porous material forming the second layer 32 include the non-woven fibers and porous bodies described above regarding the puncture needle 33 . As indicated by the arrow A4 shown in FIG. 4, the plasma components separated by the first layer 31 migrate from the first layer 31 to the second layer 32 and move toward the end 325 of the second layer 32 by capillary action. Migrate further.

As shown in FIG. 4, the second layer 32 has a coloring antibody-carrying layer 321, a specimen detection line 322, and a control line 323. As shown in FIG. The coloring antibody-carrying layer 321, the sample detection line 322, and the control line 323 are arranged side by side in this order along the migration direction of plasma components, ie, the direction of arrow A4.

The coloring antibody-carrying layer 321 is a layer containing a coloring antibody, that is, a labeled antibody. A labeled antibody is an antibody that reacts with an antigenic substance (that is, a disease risk diagnostic marker) immobilized on a labeled body. Examples of labels include colloidal metal particles such as colloidal gold particles and colloidal platinum particles, and color latex particles.

The plasma components separated by the first layer 31 migrate from the first layer 31 to the second layer 32 and pass through the coloring antibody carrying layer 321 . At this time, if blood as a test sample contains an antigenic substance (that is, a disease risk diagnostic marker), a portion of the labeled antibody binds to the disease risk diagnostic marker. Then, a mixture of the labeled antibody bound to the disease risk diagnostic marker and the labeled antibody not bound to the disease risk diagnostic marker (that is, the labeled antibody only) moves toward the specimen detection line 322 .

When the labeled antibody bound to the disease risk diagnostic marker reaches the specimen detection line 322 , it is captured by the capture antibody of the specimen detection line 322 . Then, the sample detection line 322 develops color. On the other hand, the labeled antibody that is not bound to the disease risk diagnostic marker (that is, the labeled antibody only) passes through the specimen detection line 322 without being captured by the capture antibody on the specimen detection line 322 and moves toward the control line 323. . When the labeled antibody that is not bound to the disease risk diagnostic marker reaches the control line 323 , it either binds to the capture antibody on the control line 323 or reacts with the antigenic substance carried on the control line 323 . Then, the control line 323 develops color.

When blood as a test sample does not contain an antigenic substance (that is, a disease risk diagnostic marker), only the labeled antibody contained in the coloring antibody carrying layer 321 migrates toward the sample detection line 322 . Since the labeled antibody at this time is not bound to the disease risk diagnostic marker, it passes through the specimen detection line 322 without being captured by the capture antibody on the specimen detection line 322 and moves toward the control line 323 . Therefore, when the blood does not contain disease risk diagnostic markers, the specimen detection line 322 does not develop color. When the labeled antibody reaches control line 323 , it reacts with the antigenic substance in control line 323 . Then, the control line 323 develops color.

Measurement of disease risk diagnostic markers, more specifically measurement of disease risk diagnostic marker level values, is performed by known immunochromatographic measurement methods. For example, the level value of the disease risk diagnostic marker is measured by measuring the intensity of absorbance or reflectance light in the specimen detection line 322 and the control line 323 .

As shown in FIG. 4, the first light irradiation device 41 of this embodiment is provided from the specimen detection line 322 to the control line 323, and irradiates the specimen detection line 322 and the control line 323 with measurement light at the same time. The first photodetector 42 is provided from the specimen detection line 322 to the control line 323 and detects the reflected measurement light reflected by the specimen detection line 322 and the control line 323 . Alternatively, the first photodetector 42 is provided from the sample detection line 322 to the control line 323 and detects transmitted measurement light transmitted through the sample detection line 322 and the control line 323 .

The disease monitoring system 2 of this embodiment calculates the absorbance based on the transmitted measurement light detected by the first photodetector 42, and calculates the level value of the disease risk diagnostic marker based on the calculated absorbance. Alternatively, the disease monitoring system 2 of the present embodiment calculates the intensity of the reflectance measurement light based on the reflectance measurement light detected by the first photodetector 42, and measures the risk of disease based on the calculated intensity of the reflectance measurement light. Calculate the level value of the diagnostic marker. Alternatively, the disease monitoring system 2 of the present embodiment calculates the ratio of the coloring intensity of the specimen detection line 322 and the coloring intensity of the control line 323 based on the detection result of the first photodetector 42, and calculates the coloring intensity. The level value of the disease risk diagnostic marker is calculated based on the ratio of .

Next, the mode of use of the disease monitoring system 2 according to this embodiment will be described with reference to FIGS. 1 to 4. FIG.

When using the disease monitoring system 2 of this embodiment, the subject first places the middle finger or the index finger on the placing section 211 . Subsequently, the subject operates the unlocking portion 26 provided on the side surface 213 of the upper case 21 . As a result, the unlocking unit 26 unlocks the lock mechanism 241 . Then, the immunochromatographic reaction chip 3 is unlocked and moves toward the upper case 21 under the biasing force of the biasing member 25, as indicated by the arrow A2 shown in FIG.

The puncture needle 33 provided in the first layer 31 of the immunochromatography reaction chip 3 is placed on the placement section 211 through the puncture needle hole 212 provided in the placement section 211 as the immunochromatography reaction chip 3 moves. The body (finger in this usage form) is punctured. As a result, the puncture needle 33 collects blood as a test sample.

At this time, the stopper 34 provided on the puncture needle 33 contacts the peripheral portion of the puncture needle hole 212 in the upper case 21, and the immunochromatographic reaction chip 3 is prevented from moving while the puncture needle 33 is punctured into the living body. stop. Further, the stopper 34 closes the puncture needle hole 212 in a state where the puncture needle 33 is punctured into the living body.

As indicated by an arrow A3 shown in FIG. 3, the blood infiltrating the puncture needle 33 moves from the puncture needle 33 to the first layer 31 due to capillary action. The blood transferred to the first layer 31 is separated into blood cells and plasma components by the first layer 31 . As indicated by the arrow A4 shown in FIG. 4, the plasma components separated by the first layer 31 migrate from the first layer 31 to the second layer 32 and move toward the end 325 of the second layer 32 by capillary action. Migrate further.

Then, when the blood contains disease risk diagnostic markers, both the specimen detection line 322 and the control line 323 are colored. On the other hand, when the blood does not contain disease risk diagnostic markers, the specimen detection line 322 does not develop color, and only the control line 323 develops color. This is as described above with respect to FIG.

According to the disease monitoring system 2 according to the present embodiment, when the subject places a living body such as a finger on the placing portion 211 and operates the unlocking portion 26, the puncture needle 33 moves the immunochromatographic reaction chip 3. As a result, the living body is punctured through the puncture needle hole 212, and blood is collected as a test specimen. At this time, the stopper 34 stops the movement of the immunochromatographic reaction chip 3 while the puncture needle 33 is pierced into the living body. As a result, the subject can easily collect blood as a test sample in daily life using the disease monitoring system 2 according to the present embodiment.

Further, the stopper 34 closes the puncture needle hole 212 in a state where the puncture needle 33 is punctured into the living body. Therefore, the stopper 34 can prevent stray light from entering the space housing the immunochromatographic reaction chip 3 through the puncture needle hole 212 . Therefore, the first photodetector 42 can detect the reflection measuring light reflected by the immunochromatographic reaction chip 3 or the transmitted measuring light transmitted through the immunochromatographic reaction chip 3 with higher accuracy. As a result, the subject can use the disease monitoring system 2 according to the present embodiment to easily measure disease risk diagnostic markers that may be contained in blood as a test specimen in daily life. It can be carried out.

In addition, since the inner surface of the upper case 21 and the inner surface of the bottom case 22 are coated with a light-absorbing material, the detection stability of the reflection measurement light or the transmission measurement light by the first photodetector 42 is improved. can be made Furthermore, it is possible to prevent the puncture needle 33 from being visually recognized by the subject through the puncture needle hole 212 .

In addition, the subject places a living body such as a finger on the placing portion 211 provided in the upper case 21 and operates the unlocking portion 26 provided on the side surface 213 of the upper case 21 to lock the body. Mechanism 241 can be unlocked. Therefore, the subject can unlock the lock mechanism 241 with one hand, for example, and can puncture the living body such as the finger placed on the placement section 211 with the puncture needle 33 . As a result, the subject can use the disease monitoring system 2 according to the present embodiment to easily collect blood as a test specimen and the possibility that the blood as a test specimen contains blood in daily life. can be used to measure certain disease risk diagnostic markers.

Furthermore, since the first layer 31 is provided with a transition promoting structure having a structure in which the void ratio of the porous material of the first layer 31 decreases from one end 311 toward the other end 312, the first The plasma components separated by layer 31 migrate more reliably from first layer 31 to second layer 32 . As a result, the disease monitoring system 2 according to the present embodiment can detect disease risk diagnostic markers that may be contained in blood as a test specimen with higher accuracy due to the simpler structure of the transition promoting structure.

Next, the disease monitoring system 2 according to this embodiment will be further described with reference to the drawings.
FIG. 5 is a block diagram showing the main configuration of the disease monitoring system according to this embodiment.

The disease monitoring system 2 according to this embodiment further includes a control section 51 , a storage section 52 , a guide section 53 , a projection device 54 and a communication section 55 . The control unit 51 has a disease risk diagnosis unit 511 and a display processing unit 512, reads a program 521 stored in the storage unit 52, and executes various calculations and processes. The disease risk diagnosis unit 511 and the display processing unit 512 are implemented by the control unit 51 executing a program 521 stored (stored) in the storage unit 52 . Note that the disease risk diagnosis unit 511 and the display processing unit 512 may be realized by hardware, or may be realized by a combination of hardware and software.

The disease risk diagnosis unit 511 calculates the level value of the disease risk diagnosis marker and diagnoses whether or not there is a possibility that the disease risk diagnosis marker is contained in the blood serving as the test sample. For example, the disease risk diagnosis unit 511 calculates the absorbance based on the transmission measurement light detected by the first photodetector 42, and calculates the level value of the disease risk diagnosis marker based on the calculated absorbance. Alternatively, the disease risk diagnosis unit 511 calculates the intensity of the reflection measurement light based on the reflection measurement light detected by the first photodetector 42, and based on the calculated intensity of the reflection measurement light, the disease risk diagnosis marker Calculate the level value of Alternatively, the disease risk diagnosis unit 511 calculates the ratio of the coloring intensity of the sample detection line 322 and the coloring intensity of the control line 323 based on the detection result of the first photodetector 42, and the ratio of the calculated coloring intensity is Based on this, the level value of the disease risk diagnostic marker is calculated.

The display processing unit 512 transmits a signal related to at least one of the examination progress and the examination result of the disease risk diagnostic marker to the communication unit 55 based on the reflected measurement light or transmission measurement light detected by the first photodetector 42 . The information is sent to the display device 6 via the display device 6, and a display process is executed to display at least one of the examination progress and the examination results of the disease risk diagnostic marker on the display unit 61 of the display device 6. FIG. For example, the display processing unit 512 executes display processing for displaying changes over time in the level values of the markers for diagnosing disease risk calculated by the disease risk diagnosing unit 511 on the display unit 61 of the display device 6 using graphs, tables, or the like. do. Further, when the level value of the disease risk diagnostic marker calculated by the disease risk diagnostic section 511 is higher than a predetermined threshold, the display processing section 512 determines whether the disease risk diagnostic marker is included in the blood as the test specimen. display processing for displaying on the display unit 61 of the display device 6 that there is a possibility that the

Examples of the display device 6 include portable electronic terminal devices such as smartphones and tablet computers. Alternatively, the display device 6 may be a display mechanism that is incorporated in a mirror surface or a wall surface and performs electronic display. The display unit 61 is a display provided in the display device 6, and may be, for example, a display including a touch panel capable of detecting contact of a user's finger. Note that in the block diagram shown in FIG. 5, the display device 6 is provided separately from the disease monitoring system 2 according to the present embodiment. However, the display device 6 may be provided integrally with the disease monitoring system 2 as part of the disease monitoring system 2 according to this embodiment.

Alternatively, the display processing unit 512 outputs a signal related to at least one of the examination progress and the examination result of the disease risk diagnostic marker based on the reflected measurement light or transmission measurement light detected by the first photodetector 42. 54, and controls the projecting device 54 to project and display at least one of the examination progress and examination results of the disease risk diagnostic markers. For example, the display processing unit 512 controls the projection device 54 to project and display changes over time in the level values of the disease risk diagnosis markers calculated by the disease risk diagnosis unit 511 using graphs, tables, and the like. Further, when the level value of the disease risk diagnostic marker calculated by the disease risk diagnostic section 511 is higher than a predetermined threshold, the display processing section 512 determines whether the disease risk diagnostic marker is included in the blood as the test specimen. Control is executed to cause the projection device 54 to project and display that there is a possibility that

The projection device 54 projects and displays at least one of the examination progress and the examination result of the disease risk diagnostic marker on a place such as a mirror surface or a wall surface that is easily visible to the subject.

The storage unit 52 stores the program 521 . The program 521 includes a sequence program for measurement, an image processing program for image processing, an arithmetic program, and the like. Examples of the storage unit 52 include a semiconductor memory built into the disease monitoring system 2 and the like. Alternatively, the storage unit 52 may be a CD (Compact Disc), a DVD (Digital Versatile Disc), a RAM (Random Access Memory), a ROM (Read Only Memory), a hard disk, a memory card, etc. that can be connected to the disease monitoring system 2 . storage media, data servers, and the like. Note that the program 521 is not limited to being stored in the storage unit 52, and may be stored in advance in a computer-readable storage medium and distributed, or downloaded to the measuring instrument body 4 via a network. good too.

As shown in FIGS. 3, 4 and 5, the disease monitoring system 2 according to this embodiment further includes a second light irradiation device 43 and a second photodetector 44. FIG. As shown in FIGS. 3 and 4, the second light irradiation device 43 corresponds to the other end 312 of the first layer 31 of the immunochromatographic reaction chip 3 in either the upper case 21 or the bottom case 22. portion, and irradiates measurement light toward the other end portion 312 of the first layer 31 . In the disease monitoring system 2 shown in FIG. 3, the second light irradiation device 43 is provided in a portion of the upper case 21 corresponding to the other end 312 of the first layer 31 of the immunochromatographic reaction chip 3 . The second light irradiation device 43 is, for example, a light emitting diode, and irradiates light of a predetermined wavelength.

As shown in FIGS. 3 and 4, the second photodetector 44 corresponds to the other end 312 of the first layer 31 of the immunochromatographic reaction chip 3 in either the upper case 21 or the bottom case 22. portion and detects the light emitted from the second light irradiation device 43 . In the disease monitoring system 2 shown in FIG. 3 , the second photodetector 44 is provided in a portion of the bottom case 22 corresponding to the other end 312 of the first layer 31 of the immunochromatographic reaction chip 3 . The second photodetector 44 is, for example, an array photodiode. For example, the second photodetector 44 detects reflected measurement light emitted from the second light irradiation device 43 and reflected at the other end 312 of the first layer 31 . Alternatively, the second photodetector 44 detects the transmitted measurement light emitted from the second light irradiation device 43 and transmitted through the other end 312 of the first layer 31 . In the disease monitoring system 2 shown in FIG. 3 , the second photodetector 44 detects the transmitted measurement light emitted from the second light irradiation device 43 and transmitted through the other end 312 of the first layer 31 . When the second photodetector 44 detects the reflected measurement light emitted from the second light irradiation device 43 and reflected at the other end 312 of the first layer 31 , the second photodetector 44 detects the upper part near the second light irradiation device 43 . It is provided in case 21 .

As shown in FIGS. 1 and 2 , the guide portion 53 is provided in the vicinity of the mounting portion 211 , more specifically in the vicinity of the puncture needle hole 212 . When the second photodetector 44 detects that the blood as the inspection specimen has reached the other end 312 of the first layer 31 based on the reflected measurement light or the transmitted measurement light, it is placed on the placement section 211 . The separation of the living body from the placing section 211 is guided. Guidance of separation may be performed by the guide part 53 emitting light, or by the guide part 53 generating sound.

According to the disease monitoring system 2 according to the present embodiment, the display processing unit 512 of the control unit 51 determines the disease risk diagnostic marker based on the reflection measurement light or the transmission measurement light detected by the first photodetector 42. A display process for displaying at least one of the examination progress and the examination result on the display unit 61 of the display device 6 is executed. Therefore, by confirming the display unit 61 of the display device 6, the subject can easily recognize at least one of the examination progress and the examination result of the disease risk diagnostic marker.

In addition, the projection device 54 displays at least one of the examination progress and examination results of the disease risk diagnostic marker on a mirror surface or a wall surface based on the reflected measurement light or transmission measurement light detected by the first photodetector 42 . It is possible to project and display in a place where the subject can easily visually recognize. Therefore, the subject can easily perceive at least one of the examination progress and the examination result of the disease risk diagnostic markers by checking the display projected on a mirror surface, wall surface, or the like.

Further, when the second photodetector 44 detects that the blood as the inspection specimen has reached the other end 312 of the first layer 31 based on the reflected measurement light or the transmission measurement light, the guide section 53 is loaded. The separation of the living body placed on the placement section 211 from the placement section 211 is guided. Therefore, the subject can easily recognize that the blood collection as the test sample is completed and the living body placed on the placement section 211 can be separated from the placement section 211 . Further, since the guide portion 53 is provided in the vicinity of the placement portion 211, more specifically in the vicinity of the puncture needle hole 212, the subject can place the living body placed on the placement portion 211 on the placement portion. 211 can be recognized more reliably.

The embodiments of the present invention have been described above. However, the present invention is not limited to the above embodiments, and various modifications can be made without departing from the scope of the claims. Some of the configurations of the above embodiments may be omitted, or may be arbitrarily combined in a manner different from the above.

2: Disease monitoring system 3: Immunochromatographic reaction chip 4: Measuring instrument main body 6: Display device 21: Upper case 22: Bottom case 23: Hinge part 24: Reaction chip holder 25: Biasing Member 26: Unlocking part 31: First layer 32: Second layer 33: Puncture needle 34: Stopper 41: First light irradiation device 42: First photodetector 43: Second light Irradiation device 44: Second photodetector 51: Control unit 52: Storage unit 53: Guide unit 54: Projection device 55: Communication unit 61: Display unit 211: Placement unit 212: Puncture Needle hole 213: Side surface 223: Side surface 241: Lock mechanism 242: Protrusion 311: One end 312: The other end 321: Chromogenic antibody-carrying layer 322: Specimen detection line 323 : control line 324: notch 325: end 331: tip 511: disease risk diagnosis unit 512: display processing unit 521: program

Claims (10)

A disease monitoring system for collecting a test sample and measuring a disease risk diagnostic marker that may be contained in the test sample,
a bottom case;
an upper case connected to the bottom case and having a placement portion on which a living body is placed;
an immunochromatographic reaction chip that is housed between the bottom case and the upper case, has a puncture needle that punctures the living body, collects the test sample, and detects the disease risk diagnostic marker;
a reaction chip holder provided in at least one of the bottom case and the upper case, holding the immunochromatographic reaction chip, and having a locking mechanism for locking the immunochromatographic reaction chip;
a biasing member provided in the bottom case for biasing the immunochromatographic reaction chip toward the upper case;
an unlocking portion provided in at least one of the bottom case and the upper case for unlocking the locking mechanism;
a light irradiation device provided in either the bottom case or the upper case for irradiating measurement light toward the immunochromatographic reaction chip;
A photodetector provided in either the bottom case or the upper case for detecting reflection measurement light irradiated from the light irradiation device and reflected by the immunochromatography reaction chip or transmission measurement light transmitted through the immunochromatography reaction chip. When,
with
The placement section has a puncture needle hole through which the tip of the puncture needle can pass,
The immunochromatographic reaction chip receives a biasing force from the biasing member when the unlocking unit unlocks the lock of the lock mechanism, and moves toward the upper case,
A disease monitoring system, wherein the puncture needle is pierced into the living body through the puncture needle hole as the immunochromatographic reaction chip moves to collect the test sample. 2. The puncture needle according to claim 1, wherein the puncture needle has a stopper that stops the movement of the immunochromatographic reaction chip and closes the puncture needle hole in a state in which the puncture needle is punctured into the living body. Disease monitoring system. 3. The disease monitoring system according to claim 1, wherein the inner surface of the bottom case and the inner surface of the upper case are coated with a light-absorbing material. 4. The disease monitoring system according to any one of claims 1 to 3, wherein the unlocking portion is provided on a side surface of at least one of the bottom case and the upper case. Control for executing display processing for displaying at least one of an examination progress state and an examination result of the disease risk diagnostic marker on a display device based on the reflected measurement light or the transmission measurement light detected by the photodetector. A disease monitoring system according to any one of claims 1 to 4, further comprising a unit. The apparatus further comprises a projection device that projects and displays at least one of an examination progress and an examination result of the disease risk diagnostic marker based on the reflected measurement light or the transmission measurement light detected by the photodetector. A disease monitoring system according to any one of claims 1-4. The test specimen is the blood of the living body,
The light irradiation device is a first light irradiation device,
The photodetector is a first photodetector,
The immunochromatographic reaction chip,
a first layer provided with the puncture needle at one end and formed of a porous material for separating the blood into blood cells and plasma components;
a second layer connected to the other end of the first layer and made of a porous material to which the plasma components separated by the first layer are transferred;
has
A second measuring light is provided at a portion of either the bottom case or the upper case corresponding to the other end of the first layer, and emits measurement light toward the other end of the first layer. a light irradiation device;
provided at a portion of either the bottom case or the upper case corresponding to the other end of the first layer, and irradiated from the second light irradiation device at the other end of the first layer a second photodetector for detecting reflected measurement light reflected or transmission measurement light transmitted through the other end of the first layer;
When the second photodetector detects that the blood has reached the other end of the first layer based on the reflection measurement light or the transmission measurement light, the a guide section that guides the separation of the living body from the placing section;
The disease monitoring system according to any one of claims 1 to 6, further comprising: 3. The first layer has a migration-promoting structure that separates the blood cell component contained in the blood from the plasma component and promotes migration of the plasma component toward the second layer. 8. The disease monitoring system according to 7. The transition promoting structure has a structure in which the void ratio of the porous material of the first layer decreases from the one end of the first layer toward the other end of the first layer. 9. A disease monitoring system according to claim 8. The disease monitoring system according to any one of claims 7 to 9, wherein the puncture needle is made of a porous material, and the porous material contains a freeze-dried anticoagulant.

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