WO2002093167A1

WO2002093167A1 - Body fluid inspection apparatus

Info

Publication number: WO2002093167A1
Application number: PCT/JP2002/004584
Authority: WO
Inventors: Daiichiro Aoki; Hiromu Ishibashi
Original assignee: Kabushiki Kaisya Advance
Priority date: 2001-05-10
Filing date: 2002-05-10
Publication date: 2002-11-21
Also published as: JP2002340888A

Abstract

A body fluid inspection apparatus includes detection means for detecting chromogenic information of a plurality of chromogenic members which have reacted with a body fluid. The chromogenic information is detected by relative movement between the chromogenic members and the detection means. Furthermore, the detection means includes a plurality of elements for detecting basic color information. Moreover, the light source used for obtaining chromogenic information is a white light output means and the elements for detecting basic color information are a red detection element, a green detection element, and a blue detection element.

Description

Description Body fluid testing device

(Technical field)

The present invention relates to a body fluid testing device.

(Prior art)

Attempts to collect bodily fluids, react the reagents with the bodily fluids, and measure the body fluid component information based on the color of the reaction are based on the proposal of dry chemistry. In general, optical component measurement in dry chemistry has been treated as one-component color development information for one reagent paper. The use of reagents is performed. In Japanese Patent Application Laid-Open No. 6-242107, etc., reagent parts are arranged so as to be adjacent to each other, and a bodily fluid is dropped at the center. Attempts have been made to supply each of the reagents by excluding them, for example, and to cause the reagents to undergo a color reaction.

For a single component, for example, a combination configuration has been proposed, such as a glucose sensor, in which a component value is obtained from an infrared emitting element and an absorption spectrum obtained from a reagent to obtain a numerical display. However, an apparatus that converts various body fluid information into a plurality of pieces of color development information and examines the body fluid does not suffice using only an element having a specific emission wavelength. At present, using a coloring template that shows the relationship between component amounts and color development created in advance, the component amounts, etc. are determined mainly by visual comparison and comparison with actual coloration. Using a photometer Although it has been proposed to measure color development information to determine components, etc., any of these methods requires user training and is cumbersome and cannot be used easily.

In addition, seniors may find training in handling more difficult. Further, the color information based on the body fluid information is also increasing, and therefore, there is a need for a body fluid testing device that can easily and surely measure the color information.

(Summary of the Invention)

In view of the above, the present invention provides a means for detecting color information of a member that has developed a color in response to a body fluid, wherein the detection means includes a plurality of elements for detecting color information having unity. Color information is divided into basic color information such as primary color information. This facilitates the processing of each color information, and the combination of each basic color makes it easy to construct the original color development information, thereby enabling accurate testing of body fluid components.

Further, in the device of the present invention, the member that has developed the color in response to the body fluid and the means for detecting the color information detect the information while relatively moving. Thus, information on a plurality of coloring members can be obtained in a short period of time and easily.

The bodily fluid in the present invention is obtained from blood, urine, sweat, or other living organisms. When these are solids, they may also include those dissolved therein.

A reaction-colored member is a member in which a reagent that reacts with and develops a color with a bodily fluid is formed in a state of contact with the bodily fluid, and includes a glucose measurement reagent, a uric acid measurement reagent, a total cholesterol measurement reagent, and a calcium measurement reagent. Reagents, reagents for albumin determination, reagents for alkaline phosphatase determination Nonwoven fabrics, papers, and carriers impregnated with a drug or the like are exemplified.

In addition, various reagents described in Japanese Patent Application Laid-open No. Hei 10-204 619, Japanese Patent Application Laid-open No. Hei 10-204 6 Other configurations are preferably used.

Note that the reaction between the body fluid component and the reagent is not limited to a reaction in which a covalent bond state changes like a dehydration reaction, but may be a reaction such as an adsorption reaction due to a hydrogen bond or an intermolecular force. For example, a solution containing nucleic acids and proteins extracted from cells, blood, etc. can be regarded as a body fluid.However, when a nucleic acid having a base sequence that binds to the nucleic acid complementarily is used as a reagent, a reaction like a hybridization reaction occurs. is there. In addition, the reaction coloring is not limited to coloring caused by a chemical reaction between a reagent and a body fluid component. For example, when the color or luminescence of the body fluid component itself or a substance previously added to the body fluid component is observed as a difference in average concentration depending on the amount of the body fluid component reacted with the reagent, As a result, different color information is obtained, so that it can be regarded as coloring.

The basic color information in the present invention is, for example, three primary color information of red, green, and blue (R, G, B) and analyzed as CYMK (cyan, yellow, magenta, black). If the primary color information and the measurement color are within a specific range, the primary color information is an example of valid primary color information within that range, and is appropriately selected depending on the measurement target color and the like.

The body fluid testing apparatus of the present invention has a function of making a comprehensive use of not only color information from a single reagent but also color information from a plurality of reagents as in a general blood test. . Furthermore, in the event that an urgent infectious disease or the like occurs, taking into account the advantage that the patient can immediately examine the medical condition, if information on changes in the medical condition can be obtained together, emergency treatment and medical Is also more appropriate. Therefore, a reagent for determining the amount of a certain body fluid component and a reagent for determining the change in the amount Reagents may be placed. For example, place a reagent to determine the amount of protein that reflects a disease state and a reagent to determine the amount of mRNA involved in the synthesis of that protein. From the amount of protein, it is possible to know the current condition, but not to the state of its change. However, if the amount of mRNA can also be examined, it is possible to predict a change in the amount of protein, since protein expression occurs after expression of mRNA. In concrete terms, even if the amount of protein is not so large, if the amount of mRNA is relatively large, the condition can be predicted to worsen in the future. Conversely, if the amount of mRNA is relatively low, one can predict that the condition is heading for recovery. Furthermore, if the nucleic acid of a virus can be examined with a reagent, it is possible to determine what kind of disease will be infected when, and how the condition will change in the future. , Very useful. The information on the amount and change of the body fluid component may be separately examined. It is not necessary for the body fluid testing device itself to have the function of measuring the amounts of proteins and nucleic acids, and the information obtained by the external testing means is input, and as a result, the above-described determination becomes possible. May be.

(Brief description of drawings)

FIG. 1 is a diagram showing a body fluid testing device according to one embodiment of the present invention, FIG. 2 is a diagram schematically showing a partial structure of a body fluid testing device according to another embodiment of the present invention,

FIG. 3 is a diagram schematically showing a partial structure of a body fluid testing device according to still another embodiment of the present invention,

FIG. 4 is a diagram schematically showing a partial structure of a body fluid testing device according to still another embodiment of the present invention, FIG. 5 is a diagram schematically showing a partial structure of a body fluid testing device according to still another embodiment of the present invention,

FIG. 6 (a) is a diagram schematically showing a partial structure of a body fluid testing device according to still another embodiment of the present invention,

FIG. 6 (b) is a cross-sectional view taken along line a—a ′ of FIG. 6 (a).

FIG. 7 is a diagram showing a configuration of a diagnostic system using the body fluid testing device of the present invention,

FIG. 8 is a diagram showing a schematic configuration of a body fluid testing device according to still another embodiment of the present invention.

FIG. 9 is a diagram showing an example of a bodily fluid test unit used in the bodily fluid test device of the present invention, and

FIG. 10 is a diagram showing a configuration of an apparatus for attaching a body fluid to the body fluid inspection unit of FIG.

(Example)

An embodiment of the present invention will be described in detail with reference to FIG.

Reference numeral 1 denotes a light-emitting means, such as a white LED, a white light, etc., which emits white light, such as a white LED. Among them, a white LED which is excellent in quantitativeness of the distribution of the three primary colors is preferable, but the color to be measured is When there is a tendency for white LED, there is a case that it is not particularly limited to white LED.

Further, in the case where a reagent which emits fluorescence by reacting with a body fluid component or which reacts with a reagent after previously staining a body fluid with a fluorescent light, the light-emitting means 1 may be omitted.

Reference numeral 2 denotes a filter. When detecting red, a color filter 21 made of a red translucent member or the like is used. For blue, a color filter 22 made of a blue translucent member is used. If so, a color filter 23 made of a green translucent member or the like is exemplified. Reference numeral 3 denotes a light receiving element for converting received light into an electric signal, and examples thereof include a phototransistor and another optical semiconductor element each of which is the same.

The light receiving element 31 is connected to a color filter 21 made of a red translucent member or the like, and the light receiving element 32 is connected to a color filter 22 made of a blue translucent member or the like. Numeral 3 is connected to a color filter 23 made of a green translucent member or the like.

Note that a CCD sensor or CMOS sensor in which a plurality of filters 21 to 23 and light receiving elements 31 to 33 transmitting these colors are arranged in a linear or two-dimensional plane is also used as the light receiving element. . When such an element is used, color information can be obtained as an image, and unevenness in color development of each reagent can be corrected, so that more accurate processing can be performed.

Numeral 4 is an adjusting means, which includes an A / D converter for converting the light amount of each light receiving element into digital data when performing digital processing while performing amplification adjustment, noise filtering, etc. This is a means for performing necessary adjustments in order to calculate and compare the electric signal at a later stage.

The adjusting means 41 is connected to the light receiving element 31 via the connecting member 91, the adjusting means 42 is connected to the light receiving element 32 via the connecting member 92, and the adjusting means 43 is connected to the light receiving element 32. Connected to light receiving element 33 via member 93

Reference numeral 5 denotes a processing means, which comprises a combination of a computer, a combination of digital logic elements, and a combination of analog logic elements, and calculates and calculates respective color information based on signals obtained from the adjustment means. This is a means for forming and outputting color information by combining the light quantity data of the basic colors recorded in advance and the combined colors based on a table associating them.

6 is a judgment means, which is a combination of a computer and a digital logic element. It consists of a combination configuration and a combination of analog logic elements.From the obtained color information signal, a display signal indicating the amount of the body fluid component to be measured is used, and a pre-recorded color and volume determination table, function, etc. are used. This is for displaying on the screen, storing it temporarily or continuously, and outputting it to an external diagnostic institution via a network. It should be equipped with ancillary equipment according to the network.

The processing means 5 and the determination means 6 may use the same hardware configuration. In addition, information such as a function indicating the correlation between the color information and the amount of the body fluid component does not need to be recorded in the body fluid testing device in advance, and may be obtained from an external network or an external storage medium at the time of use, or may be used as a reagent unit. May be recorded on a body fluid test chip or the like having If the number of reagents or test chips is increased or the shape or quantity of the reagent section is changed as necessary, using these means does not require any changes to the hardware configuration of the body fluid testing device. It is convenient.

Reference numeral 7 denotes a display storage means for displaying information desired by the user on a medium such as a liquid crystal display or paper, and for storing data such as IC memory cards, FD, MO, CD, and CD-RW. This includes those for temporary or continuous recording.

Note that the display storage means 7 may have only a display function without having a storage function. In the case where the display storage means 7 is used on the assumption that it is connected to a device having a display function, such as a portable information terminal and a computer, the display storage means 7 may be omitted. Further, the display storage means 7 may have an information input function. For example, if there is a function that displays characters, numbers, symbols, figures, etc. when necessary, and touches them with a finger or a special device, information such as name and date can be input. There is no need to separately configure buttons, etc. A) The configuration is simplified.

Reference numeral 8 denotes an external connection unit, which is a connection unit for transmitting body fluid data to the outside. If the transmission medium to the outside is wireless, it is connected to an antenna via a modulation circuit, and if it is wired, it is for connection to an optical fiber, telephone line, or other line. It has an interface to connect to

The external connection unit 8 is provided, for example, when the judging means 6 is information that the side using the data can sufficiently know the amount and type of the body fluid component, when there is no need to know any more information, the display storage means 7 In the case where a removable storage medium such as a disk is used and sent to an external organization for the purpose, it may not be necessary.

The body fluid data connected to the external connection unit 8 is data indicating a reaction color obtained by reacting with a reagent, or data that is determined by a color determination, such as the type and amount of a body fluid component, or light reception. The element 31 outputs the signal, and in some cases, the adjusting means 41 converts the signal into a red electric signal that has been electrically amplified or converted into a digital signal and a modulated signal, and has a connection relationship (blue, green) The same applies to the electrical signal).

In this way, the configuration that modulates digital and analog data output by the light-receiving element and outputs it as it is and transmits it to the outside, and the configuration that transmits color information to the outside can further reduce the burden on patients and accumulate information. In some cases, a diagnostic institution with a large amount and high analytical ability has the advantage of being able to perform detailed analysis.

Reference numerals 91, 92, and 93 denote connection members that transmit electric signals, and indicate lead wires or, in the case of a board integrated type, channels on an electric board. The connection members 91, 92, and 93 may be used when connecting the components.

A is a reagent part, and K is a holding member for holding the reagent part. You. Although only one reagent section A is shown in the figure, it is merely for explaining the operation, and a plurality of reagent sections may be provided in parallel.

Next, the operation will be described. '

The light emitting means 1 irradiates the colored sample surface A. The light applied to the sample surface A is reflected and received by the color filter 2. Each of the color filters 21 to 23 passes light having a desired color. The passed light is converted into an electric signal by the light receiving elements 31 to 33. Specifically, the color filter 21 passes the red component of the received reflected light, and the passed red component is input to the light receiving element 31. The color filter 22 passes the blue component of the received reflected light, and the passed blue component is input to the light receiving element 32. The color filter 23 passes the green component of the received reflected light, and the passed green component is input to the light receiving element 33.

The red component signal, the blue component signal, and the green component signal that have been converted into electric signals in the light receiving element 3 are output to the adjusting means 41 to 43 via the connecting members 91 to 93, respectively. The color information converted into a digital signal by the amplification, filtering, and AZD conversions by the adjustment means 41 to 43 respectively is processed by the processing means 5 to determine a total number of colors based on each light amount. The judgment signal is output to the judgment means 6. The judging means 6 judges the amount of the component to be measured from the color information input in this way to create judgment data. The determination data is converted into a display signal corresponding to a target display mode and output to the display storage means 7. The display storage means 7 stores the input display signal and also displays the numerical value, graph, or the like. To display on the display. Further, when the transmission destination of the determination data is external, the determination data is output to the external connection unit 8 so that the determination data is stored in a removable storage medium or transmitted to the other party via a telephone line or the like. In order to recognize the detailed data, it is necessary to store the data for the template in a relatively large memory, but in such a case, the color data itself is recorded without the judgment means 6. The information may be recorded on a medium and sent to an external diagnostic institution by mail or transmitted to an external institution online.

In this embodiment, in order to increase the amount of color detection by condensing light when the area of the reagent section A is large or when the color development is uneven, the light concentrating tool S such as a lens is used for the sample A. It may be interposed between the surface and the color filter 2.

Further, in the present invention, as shown in FIG. 2, a passing-type device that passes the output light of the light emitting means 1 through the sample A may be formed with the sample A interposed therebetween. In this case, more accurate coloring data may be obtained. In this case, the sample A in this case may require a carrier that is thin enough to have optical transparency and adjustment of the sample concentration and the like.

When there is a supporting member for supporting the carrier in a direction in which light passes, it is preferable that the supporting member is formed of a transparent member or a member having a light transmitting property.

Further, the present invention is not limited to the light emitting means 1 because it is sufficient that at least the color information is received by dividing the basic light by a light receiving element having a relatively simple configuration into basic light, and the color can be determined by comprehensively processing the basic light. For example, various external lighting means such as a fluorescent lamp, an incandescent lamp, and sunlight can be used.

An example of such a case is shown in FIGS.

In FIG. 3, reference numeral 103 denotes a filter for transmitting light of a specific wavelength, and when using external illumination light as a light source, a color for removing a color component unnecessary for coloring of the coloring member. Filter. The light passing through the filter 103 is irradiated on the sample, and the reflected light is further passed through the basic light. The light is received by the light receiving element 3 via the filter 2 to be passed. As a result, the color information is converted into an electric signal, output to the adjusting means 4 shown in FIG. 1, and determined as a color.

FIG. 4 shows an embodiment in which the configuration shown in FIG. 3 is a transmission type. 101 is the above-described filter, and 102 is a light collecting member for collecting transmitted light. The light-collecting member 102 is exemplified by a lens, but may have a mirror-finished light-collecting configuration. Such a light-collecting member is similarly used in the embodiment of FIG. It is possible. As described above, the use of external lighting as a light source simplifies the configuration of this device, and promotes the miniaturization of this device.

By the way, since the determination of color information is a relative one that fluctuates depending on the illumination light, for example, the determination of reagent coloring also uses relative determination data in advance and uses more general illumination. In some cases.

In addition, instead of visible light, an aggregate of specific wavelengths, a plurality of laser lights having different wavelengths, etc. are used as illumination light, and the illumination light can be received and separated at least for each wavelength. It is also possible to use a plurality of light receiving elements for receiving light.

Next, an embodiment shown in FIG. 5 will be described. Reference numerals 201 to 203 denote light transmitting members on the light receiving side, which are composed of optical fibers, glass tubes, and the like. Reference numeral 204 denotes a light transmitting member on the irradiation side, which is made of an optical fiber, glass, or the like. Reference numerals 206 to 208 denote filters, which are similar to the filters 21 to 23 shown in FIG. Reference numerals 209 to 211 denote phototransistors, each of which is an example of a light receiving element. Reference numeral 205 denotes a light emitting diode, which is mainly composed of a white diode. Reference numeral 2 1 denotes a power supply terminal, which is supplied with a direct current of about several volts for emitting light of a diode and for driving a light receiving element. I have. Reference numerals 2 13 to 2 14 denote output ends of the light receiving elements, which are connected to the transmission members 91 to 93 in FIG. 1, respectively. The collector side of the phototransistor and the cathode side of the light emitting diode, respectively, are connected to the power supply terminal 211 via a resistor.

This embodiment has the same configuration as that of the embodiment shown in FIG. 1 except that the light transmitting members 201 to 204 are used. However, the light emission for obtaining the coloring state from the sample surface is shown. It is suitably used when the light receiving space is very limited. It can also be used effectively, for example, when the sample surface is too narrow than the light receiving surface of the light receiving element to receive light sufficiently, or when the irradiation surface of the irradiation means cannot sufficiently irradiate the sample. As described above, depending on the state of the sample surface and the irradiation and light receiving spaces, either the irradiation or the light receiving means may not require a light transmitting member.

In the examples shown in FIGS. 1 to 5, although not explicitly shown in the drawings, the sample A may have a plurality of coloring members, and in that case, at least the sample A or the light receiving means is required. By moving one, a plurality of component information is continuously obtained from a plurality of coloring members.

FIG. 6 shows an embodiment in which a light receiving element and a light emitting element are applied to a state in which a plurality of samples are formed in a circular radial shape. FIG. 6B is a cross-sectional view taken along line a_a ′ of FIG. 6A. Reference numeral 600 denotes a light-emitting element, which is formed of a white LED or the like. Reference numeral 602 denotes three filters, including, for example, a filter that passes red, green, and blue as shown in FIG. Reference numeral 603 denotes a light receiving element group, which corresponds to the light receiving element indicated by reference numeral 3 in FIG. Reference numeral 604 denotes a power supply unit for causing the light emitting element 601 to emit light, and reference numeral 605 denotes a transmission member, which is omitted in the figure, but is provided with adjusting means 41 to 43 shown in FIG. And each connected. T is a dropping portion of a body fluid, for example, a portion into which blood or blood diluted with physiological saline or the like (hereinafter referred to as blood or the like) is dropped. To the dropping part T In some cases, a porous sheet for separating blood cells may be interposed.

Reference numeral 606 denotes a porous sheet member, which preferably has a blood cell separating function when the body fluid is blood, for example, a Hemasep (trademark) L membrane or the like is suitably used. If the bodily fluid to be dropped is a material from which unnecessary substances have already been removed, a porous material such as a nonwoven cloth which promotes diffusion and penetration of the bodily fluid may be used.

A dropping portion T is provided at the center of the porous sheet member 606, and a reagent portion 608 to 613 is disposed around the dropping portion T, for example, so as to be embedded therein. In order to support the supporting member, a supporting member 607 having water impermeability and preferably formed of a light transmitting member is additionally provided. The specific configuration utilizes the configuration disclosed in Japanese Patent Application Laid-Open No. H10-2066418. The one described in Japanese Patent Application Laid-Open No. 2006-420 is preferably used. These conventional configurations show a case where the direction in which the body fluid is dropped and the direction in which the color reagent is measured are common in one direction. However, the present invention is not limited to this. For example, the direction in which the body droplet is downward and the direction in which the color reagent is measured are as follows. It may have a configuration like Japanese Patent Application No. 2000-0-37205 on the other side. In this case, the positions of the light emitting element and the light receiving element may be different.

Also, since the dropping part is almost unnecessary after dropping the bodily fluid, this part may be removed and used as a rotary shaft mounting hole. The supporting member 607 can further be rotated manually or automatically around the drip portion, and the operation thereof is performed by a positioning rotation operation with respect to the combination of the light emitting element and the light receiving element, and depending on the case. In some cases, the rotating operation is performed such that a centrifugal force for promoting the penetration of blood or the like into the reagent section can be expected. The direction and speed of rotation are appropriately adjusted depending on the purpose.

An example of positioning during rotation is defined as markers 6 14 to 6 19 Show. The marker has, for example, a color value (for example, pure white, pure red, or the like) that does not produce a color with respect to the color value of the reagent part that is colored by contact between various body fluids and the body fluid. Due to the rotation of the support member 607, when the combined portion of the light emitting element 601 and the light receiving element group 603 has passed through the power, the color is received, and the judgment means 6 shown in FIG. Judge as a marker. For example, if the marker 614 indicates the reagent section 608 to be measured first, the determination means of FIG. 1 detects the marker 614 while the support member 607 is rotating. Then, after a predetermined time, when the reagent section 608 reaches the site of the light emitting element 601 and the light receiving element group 603, the rotation is stopped and the reagent section 608 is measured. I do. In addition, if sufficient light can be received for measurement in a rotated state, the light receiving operation can be performed while rotating.

When the next marker 615 is received by the light receiving element group 603, a predetermined time after that, the reagent part 603 is provided at the site of the light emitting element 601 and the light receiving element group 603. When 9 has been reached, the light receiving element repeats the process when light reception starts, and measures up to the reagent section 6 13. When the support member 607 is repeatedly rotated and stopped, a high function is required for the motor as the rotating means. Therefore, the configuration is such that the motor is constantly rotated to detect and measure the reagent portion. However, it has the advantage that an inexpensive motor can be used. Further, it is preferable to use a media drive such as a floppy disk drive, an MD disk drive, or a CD drive, and to continuously measure the coloring pattern of the reagent section at a speed at which the media drive is constantly rotating.

If the coloring pattern has a characteristic for each reagent part in advance, the reagent part can be recognized by continuously measuring the coloring value without using a marker. In this case, it is desirable that the color of the porous member 606 be a color (for example, black) that does not hinder the measurement of each reagent part. However, the present invention is not limited to this.

In the present embodiment, each of the reagent parts is impregnated with a reagent for the component to be measured by coating the carrier or the like. First, for example, blood or diluted blood is dropped into the dropping portion T. The production of diluted blood is described in, for example,

The technique described in JP-A-11-18853-475 is used. The blood and the like dropped on the lower part of the droplet T are separated by the centrifugal force if the blood cell separation material is interposed, and the blood cells are separated around the lower part of the droplet τ. It penetrates uniformly into each reagent part.

After that, after the supporting member 607 rotates and stops at a predetermined position of the reagent section 608, color information is detected at the reagent section 608 by optical measurement as shown in FIG. After the member 607 rotates and stops at a predetermined position of the reagent section 609, the same optical measurement is performed, and color information is detected.

This operation is sequentially repeated, and the rotation is stopped when the measurement is performed up to the reagent section 6 13. Examples of the rotating operation include the use of a motor that can be positioned by electric control such as a servomotor, a mechanical drive such as a spring mechanism, and a manual operation.

In addition, in addition to the reagent unit as in this embodiment, when the reagent unit is arranged in a line or when blood is dropped and allowed to react with each reagent unit, the color of the reagent unit is measured in a disk shape. When they are used, they may be used in series or separately.

Another embodiment of the present invention is shown in FIG. 7 and will be described in detail. Reference numeral 800 denotes the main body of the instrument, which incorporates therein a light emitting means and a plurality of basic color light receiving means as shown in FIG. 6 and the like, and further comprises a heating means for accelerating the reaction of the reagent part. I have it. Reference numeral 825 denotes display means, which is formed of a liquid crystal or the like, and displays measurement state information, measurement result information, or information indicating a measurement method. 8 2 6 turns the measurement operation on and off. This is an operation switch mainly for external input, such as a switch for transmitting and receiving data.

Reference numeral 800 denotes an inspection unit, and as shown in FIG. 6, a disk-shaped porous member 800 having a plurality of reagent portions 804 and a dropping portion 803 is connected to an inspection unit 201. It is mounted rotatably on the top. 805 is data for identifying a patient, and preferably has a mechanically readable identification symbol. The identification data 800 is composed of, for example, a par code or a character string. Further, the identification data 800 has a storage unit such as a magnetism, a magneto-optical, and the like, so that the data can be stored and corrected.

Reference numeral 806 denotes an insertion port, into which the inspection unit 801 is inserted. Reference numeral 807 denotes a personal memory, which is an IC card, a memory card, and other storage media that can be read and, in some cases, written. Reference numeral 808 denotes a measurement operation memory, which mainly includes data such as a measurement item that varies depending on a patient, operation information for measurement, and the like, such as a procedure for driving the inspection unit and information processing, and a light receiving color and component. It has a configuration in which table data and the like showing the detailed relationship of data are recorded, readable, and in some cases, writable. 809 and 810 are memory entry points, respectively.

Reference numeral 811 denotes an antenna which enables wireless transmission and reception of data and, in some cases, transmission and reception of voice. The antenna 811 is provided as needed. 8 14 are diagnostic institutions, such as medical-related centers and health management service centers, which perform various disease diagnoses based on the body fluid information and transmit diagnostic data to patients, clients, etc. .

Reference numeral 815 denotes a terminal device, which is composed of a personal computer or the like, and is a data which can be easily diagnosed by the data created by the device main body 800. It has an intermediary function to convert between the device main body 800 and the diagnostic institution 8 14, and to make a simple diagnosis based on the correspondence table between the built-in diagnosis and test information. . If data can be exchanged directly between the diagnostic institution 814 and the device main body 800, it may be unnecessary.

Reference numerals 816 and 818 denote connection organizations that connect the network 817 and the terminal devices 815. This is, for example, the provider if the network 817 is the Internet, the communication means 820, and the communication between the patient, the client 823 and the diagnostic institution 814. Things. If the patient and the client 8 23 have specialized knowledge of personal computers, they may use e-mail etc. via the terminal device 8 15, but for the elderly, etc., letters, faxes, telephones, etc. If the device main body 800 has a communication function, the device main body may be configured to communicate by voice or liquid crystal display.

Further, in the present embodiment, a means for heating each reagent portion may be provided to promote the reaction between the reagent of the test unit to be introduced and the body fluid. The heating means is, for example, a nickel heater, an infrared laser, an incandescent light bulb, etc., and is set in the main body 800 since at least after the body droplet is dropped, it can be subjected to a permeation reaction process into each reagent part. The inspection unit may be installed in the inspection unit 801 or may be installed in the process until the inspection unit is inserted into the measuring device body 800. good.

The operation of this embodiment will be described. The patient carries the test unit 8101 in advance or at the time of the test. The inspection unit 801 is equipped with a rotatable and possibly replaceable support 802. The identification data 805 records the purpose of the examination, the case, and the like. Patient or dependent The requester 823 collects blood or the like, and in some cases, drops a body fluid 824 typified by diluting it with a physiological saline solution or the like to the drip portion 803. This work is performed mainly by the patient himself, or may be performed by a caregiver, nurse, or doctor, for example, when the bedridden elderly is a patient.

The body fluid dropped into the dropping section 803 penetrates and moves into each sample section 804 while separating blood cells, reacts with the reagent in the sample section, and develops color. When all of them can be used for the test, or when the device body 800 has built-in heating means to promote the reaction between the reagent and the body fluid, the body fluid 82 After dripping into 3, insert the inspection unit 801 into the insertion port 804. At the same time, a personal memory 807 storing the data of the patient or client performing this examination and a measurement operation memory 808 storing the contents to be measured are provided at each entrance 809, 81. Set to 0.

The device main body 800 is a general-purpose, personal memory 807 and a measurement operation memory 808 are inserted and set, so that it can be temporarily used for a specific patient or client-only machine. It can take such a configuration. Such a mode is a preferable mode when performing a body fluid test on a plurality of patients or the like, such as an elderly caregiver or a nurse. In addition, when the contents of these memories are small or for further simplification, the inspection unit 801, the personal memory 807 and the measurement operation memory 808 may be integrated.

In some cases, this device may be fixedly used as a dedicated machine for each patient. In this case, it is possible to adopt a rotating recording structure by arranging a recording medium around the support 802. That is, the personal information is sometimes merged while rotating the data obtained by measuring the amount of the body fluid component from the coloring information of the reagent section onto the recording medium G attached to the periphery of the outermost layer of the support carrier 802. With a structure that is recorded Therefore, it is possible to adopt a more abbreviated configuration.

After the test unit 801 has been inserted and the color of each reagent section 804 has been sufficiently developed, the switches 826 are operated and operated. In the state shown in FIG. 6, the light-receiving element group 603 receives the light reflected by the sample part by the light emission of the light-emitting element 601 via the RGB filters 602. Then, amplification and digital processing are performed, color information and component information based on the color information are determined, and determination data is created. This judgment data is displayed on the display means 825 and is appropriately recorded in the personal memory 807 and other recording portions described above. In some cases, simple diagnostic data may be displayed on the display means 8 25.

FIG. 8 shows the configuration of a body fluid testing device that enables more advanced processing. The body fluid inspection unit 900 is illuminated by a white light source 902 such as a white LED installed on the substrate 901. Note that the white light source 902 does not necessarily need to be present on the substrate 901. The coloring information of the reagent of the body fluid inspection unit 900 can be obtained by receiving the reflected light or transmitted light from the white light source 9002 with the light receiving element 903. The light receiving element 903 is preferably an image sensor in which photo diodes and the like are arranged in a linear or two-dimensional plane, and examples thereof include a CCD sensor and a CMOS sensor. By using such an image sensor, it is possible to measure the non-uniformity of the color in the reagent section or to measure the specific spot, as compared to the case where spot or average color information is simply obtained with a photo diode or the like. Advanced processing such as selective use of only coloring information is possible.

Further, the light receiving element 903 may be used for acquiring image information other than the color information of the body fluid inspection unit. For example, there is a case in which a necessary part of a device from which a body fluid is collected or a container containing a liquid obtained by diluting the body fluid is acquired as an image, and the amount of the fluid is calculated by using the acquired image. This one According to the law, there is no need for the user to collect a fixed amount of bodily fluids, and handling is easy.

The color information obtained by the light receiving element 903 is transmitted to the processing device 904. The processing device 904 incorporates an arithmetic circuit, a storage unit, and the like, and has input / output terminals. Note that a circuit for controlling a data processing operation may be arranged between the light receiving element 903 and the processing device 904 in some cases.

The signal processed and generated by the processing device 904 is transmitted to the display device 905, the internal storage device 906, and the external device 907. It should be noted that a signal may be input from the display device 905 or the external device 907 to the processing device 904 via the reverse route. The information input from the display device 905 or the external device 907 includes a user name or a number specifying an individual, gender, standard values of body fluid components, blood pressure, height, weight, medical history, and the like. Such information is registered in the internal storage device 906, and it is desirable that no input is required unless there is a change in the second and subsequent uses. A removable storage device may be used as the external device 907, and the above-described information may be registered in the storage device, and the storage device may be mounted when used. When the measuring device is shared by multiple users, it is sufficient to enter a personal name or a number that identifies the individual, or attach a storage device in which personal information is registered.

Connection with the external device 907 is performed through the connector 908. Examples of the external device 907 include a detachable storage device, a computer, a portable information terminal, and the like, through which a connection to an external network can be established. If the body fluid testing device also has a communication function with an external network, an antenna or the like may be attached.

Note that the function of acquiring the color information of the body fluid inspection unit 900, such as the white light source 9002 and the light receiving element 9003, is not included in the measurement device itself, and is not included in the external device 907 or external network. May be included in the You. For example, color information is obtained from a body fluid inspection unit 900 by a device such as a digital camera or a color scanner, and in some cases, the connector 908 or an antenna is connected via an external network using a portable information terminal or the like. This is a case where data is input to the measuring device from the above. With this method, if the user has a device such as a digital camera, there is no need to obtain dedicated hardware for using the body fluid testing system. A measurement operation program may be provided that operates on a computer or the like owned by the user. In addition, if the function of acquiring body fluid test unit information is separated by the user and the measurement function is separated by the administrator of a medical institution or the like, the results of analysis of the data transmitted by the user will be analyzed by doctors and administrators. Information such as add-ons can be added and returned to the user, thereby increasing the utility value.

The operation information required for measurement is input in advance to the storage unit in the processing unit 904 or the internal storage unit 906, or is recorded on the external device 907, external network, or body fluid testing unit. It can be obtained from the information provided.

Figure 9 shows an example of a simplified body fluid testing unit. Since the body fluid inspection system of the present invention is small and easy to handle, it is assumed to be used for preventive medicine, such as physical condition management of healthy patients as well as sick patients. Therefore, it is desirable to increase the frequency of use, and it is necessary to make the body fluid inspection unit as simple as possible so that it can be mass-produced at low cost.

9 is formed of paper, a thin resin sheet, or the like. 1001 is a reagent part, which is formed by a method such as printing. The reagent section 1001 contains other reagents that react with body fluid components to develop color.

It may also include a color marker used for color tone correction, a reaction information reagent that changes color only by the amount of water and pressure regardless of body fluid components, and the like. 1002 is a measurement information marker, in addition to the identification number of the test unit, the type and number of reagents, the correlation function between the degree of discoloration and the amount of body fluid components, the date of manufacture, the normal value range, diagnosis, and messages. Etc. may be included. Since the body fluid inspection system of the present invention is premised on processing the color information of the reagent, if the measurement information marker 1002 is also formed as color information such as color per code and color dot, A sufficient amount of information can be secured. If a large amount of information is included in this part, the amount of information to be held in advance by the measurement device main body can be reduced, and the type and configuration of the inspection unit can be easily changed.

The identification number of the inspection unit 100 is used when it is necessary to identify the user, for example, when the inspection result is used for calculating insurance premiums. Specifically, it is assumed that the used test unit is kept for a certain period of time by the medical institution, the user himself, or an administrator such as an insurer, while the used test unit is used. Information such as the identification number, measurement data, date of use, etc. is stored in at least one of the measurement device and the management storage device. When necessary, the body fluid left in the test unit is subjected to DNA analysis, etc., and the user can be identified by collating it with the stored data such as identification numbers. In the case where the inspection unit and the measuring device are provided with a DNA appraisal function, personal authentication based on the DNA appraisal may be performed together with the measurement. The identification number may be recorded from the measuring device at the time of use, and may be character information such as a name or a number assigned to an individual instead of the identification number.

Reference numeral 1003 denotes a seal, and at least the reagent portion 1001 is sized so that it can be pressed. Since the purpose is to protect the reagent part from the external environment, it may be a bag-like one instead of a seal. It is desirable that the seal 1003 be removed immediately before use.

By arranging the reagent sections in a per-code manner, for example, If a groove is provided in the device and the user slides the inspection unit through the groove, the measuring device can be simplified, for example, the light-receiving unit can be a linear sensor. The shape of the reagent section need not be rectangular, but may be circular or the like.

Alternatively, the light transmitting member 204 on the irradiation side and the light transmitting members 201 to 203 on the light receiving side shown in FIG. 5 are applied to an inspection unit having reagent parts arranged in a bar code. If an integrated light pen is used, color information can be easily read simply by scanning a bar code vertically with this light pen. In this case, since the user only needs to scan the light pen by himself, no driving means for configuring the relative movement between the coloring member and the detecting means is required. Therefore, the configuration of the body fluid inspection device is further simplified.

As a method of reacting the body fluid with the above-mentioned test unit, for example, the test unit is placed in a container, and a body fluid or a diluent of the body fluid is poured into the container, or conversely, a diluent of the body fluid or the body fluid is diluted. One method is to immerse the inspection unit in a container containing the test. If the reagent uses a reaction that is sensitive to temperature, such as an enzyme reaction, keep the temperature low when contacting the body fluid with the test unit, and then raise the temperature to an appropriate temperature to obtain a uniform Reaction can be expected. FIG. 10 shows an example of the inspection aid. Container 110 is filled with body fluid or body fluid diluent 1101. As a method for preparing the diluent, for example, pure water may be put in the container 110 in advance, a capillary tube or the like may be attached to the tip, and the body fluid may be sucked like a dropper. 1 1 0

Reference numeral 2 denotes a support formed of resin or the like, and a blood cell separation section 110

The blood cell separation membrane 110 is provided with a tip 110 4 having excellent liquid permeability. If the blood cell separation part 1103 is formed in a size that fits the mouth of the container 110, the support body 110 becomes unnecessary. You. In addition, when the blood cell separation part 1103 and the tip part 1104 are formed of the same material, they are integrated. The blood cell separation unit 1103 may be embedded in a part of the leading end 1104, or the blood cell separation unit 1103 itself may not be needed. By tracing the reagent part 1001 of the test unit shown in Fig. 10 in the same way as a pen with the test aid having such a structure, the body fluid and the reagent can be easily reacted. it can. In use, the patient may wait until the bodily fluid permeates into the distal end portion, or may press the container 1101 with a finger to permeate it. Individual differences such as the intensity of tracing are corrected using color information contained in the reagent section 1001 and obtained from a reaction information reagent that changes color due to moisture, pressure, or the like. The use of such inspection aids makes operation intuitive and easy to understand, and simplifies storage and recovery after use. There is no need to configure a blood cell separation unit or a body fluid developing unit on the test unit side, and mass production of the test unit is facilitated.

Further, the present invention realizes a system shown in the following cases. case 1

Personal memory 807 Other recorded data necessary for diagnosis may be sent to the diagnostic institution 8 14 by mail, personal delivery, etc. 8 13. In this case, the diagnostic institution 814 sends the diagnosis result to the patient, the client 823, the caregiver, or the like by using a communication medium 820 such as a telephone or FAX. In this case, other communication means such as the antenna 811 may not be necessary and may be simplified as a whole.

Case 2

The data created by the device body 800 is transmitted from the antenna 811 to the diagnostic institution 814 via the wireless medium 819 such as radio waves. The diagnostic institution 8 14 transmits the result of the diagnosis to the inspection terminal 800 again via the wireless medium 8 19. The transmitted diagnosis result is displayed on display means 8 25 If the device main body has voice conversion means, the device main body 800 plays the role of a mobile phone and listens to the diagnosis in real time by voice. In this case, the information may be transmitted to the patient, client, or other caregiver 8 23 by using a transmission medium 8 20 such as mail, telephone, or fax.Case 3

The device main body 800 has a connection terminal such as RS232C and USB, and an infrared input / output unit, and is connected to the computer 815 via these connection means. The diagnostic data is sent once to the terminal 815, where it is diagnosed and displayed on a monitor, or transmitted to the diagnostic institution 814 using the network 817 using a public line or a dedicated line. . At this time, if this network is the Internet, the providers 816 and 818 intervene, and in some cases, the diagnostic institution 814 and the provider 8

May include 18

The diagnostic institution 814 sends back the diagnostic results via the network 817 and the terminal 815 displays the diagnostic data in real time or using e-mail. If the data is sent directly over the public line or wireless, as in Cases 2 and 3, the recording memory may be stored as it is by the caregiver or the like operating it, or the diagnostic data may be sent. If this is the case, recording is performed using the terminal 815 and the device main body 800, which is also good.

The inspection unit 801 has a relatively simple structure since it is mainly completed after a single use, and a part of the inspection unit 801 is replaced, for example, only the support carrier 802 is replaced. A configuration that can be reused is preferable. Further, the inspection unit 800 may be formed in a disk shape to simplify the rotating structure.

A system for transmitting a diagnostic function to an external specialized organization as in the present embodiment, It is suitably used for accurately grasping coloring information and accompanying information such as body fluid components and amounts.

(The invention's effect)

As described in detail above, the present invention can detect almost all of the coloring information of the reagent portion while having a very simple configuration, and can accurately and easily grasp various body fluid components. A blood test unit that can be easily used by anyone can be realized, and at the same time, it has the effect of enabling effective and quick transmission of diagnostic information.

Claims

The scope of the claims

1. In a body fluid inspection device including a detection unit that detects individual coloring information of a plurality of coloring members that have developed a color in response to a body fluid, the detection of the coloring information is performed by relative movement between the coloring member and the detection unit. Further, the body fluid testing device is characterized in that the detecting means includes a plurality of elements for detecting basic color information.

2. The body fluid testing device according to claim 1, wherein the light source for obtaining color information by the detection means is a white output means.

3. The body fluid detection device according to claim 1, wherein the plurality of elements for detecting the basic color information are a red detection element, a green detection element, and a blue detection element.

4. The red detection element includes a red light transmission filter and a light receiving element, the green detection element includes a green light transmission filter and a light reception element, and the blue detection element includes a blue light transmission filter and a light reception element. The body fluid testing device according to claim 3, wherein the body fluid testing device is configured.

5. The body fluid testing device according to claim 2, wherein the white output means is a white light emitting diode.

6. The plurality of coloring members are arranged substantially concentrically on the carrier, and the relative movement between the coloring member and the detecting means passes through the center of the concentric circles and rotates about an axis perpendicular to the carrier. The body fluid testing device according to claim 1, wherein the rotation is:

7. The plurality of coloring members are arranged in a per-code manner on a carrier, and the relative movement between the coloring member and the detection means is a linear movement perpendicular to the bar code. Item 1. The body fluid testing device according to Item 1.

8. The body fluid testing device according to claim 6, wherein the plurality of coloring members have a marker between adjacent members.

27 Corrected Form (Rule 91)