JP2011220826A - Body fluid analyzer - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an analyzer that can equally use an inspection tool whether it is the one just taken out of a refrigerator or the one which is returned to room temperature.SOLUTION: A body fluid analyzer in which the component contained in a body fluid is analyzed through a disposable inspection tool inserted thereinto, comprises: an insertion section into which the disposable inspection tool can be inserted; a temperature measurement section which can measure temperature of the sensor section of the disposable inspection tool inserted; an input section for inputting an output from the sensor section of the disposable inspection tool inserted; heating means which can heat the sensor section; and controlling means which performs analytical processing of the component contained in the body fluid based on the output from the sensor section and controls the heating means based on an output from the temperature measurement section. When the temperature of the sensor section obtained by the temperature measurement section is lower than prescribed temperature, the control means preheats the sensor section before performing the analytical processing until the temperature of the sensor section reaches the prescribed temperature.

Description

  The present invention relates to a body fluid analyzer that can be used to analyze a body fluid, for example, a gas component in blood or measure pH, and in particular, is supplied from a body fluid introduction hole, a body fluid passage extending from the body fluid introduction hole, and the body fluid passage. The present invention relates to a body fluid analyzer that inserts a disposable inspection tool having a sensor unit capable of detecting at least one component of body fluid to be analyzed and analyzes components in the body fluid via the sensor unit of the disposable inspection tool.

This type of analyzer is used for the purpose of examining a patient's cardiopulmonary function in a hospital or the like, for example, blood acidity PH, carbon dioxide partial pressure PCO2, oxygen partial pressure PO2, sodium ion concentration Na, potassium ion concentration K, chloride ion concentration. Measurement of various gas partial pressures and ion concentrations such as Cl, ionized calcium concentration Ca, urea nitrogen concentration BUN, glucose concentration Glu, hematocrit value Hct, bicarbonate ion HCO3-, oxygen saturation SO2, total carbon dioxide amount TCO2, It is used to calculate calculation items based on various measurement results such as excess base BE and hemoglobin concentration Hgb, and various stationary and portable types have been proposed and put into practical use.
The applicant, as a stationary or portable analyzer of this type, has a disposable inspection instrument configured to be able to introduce body fluid after being inserted into the analyzer, and an analyzer used for the disposable inspection instrument. It has already been proposed (Patent Documents 1 and 2).

Japanese Patent No. 3761285 Japanese Patent No. 4041560

Since the disposable inspection tool and the analysis device according to Patent Documents 1 and 2 described above are configured so that body fluid can be introduced into the disposable inspection device after the disposable inspection device is inserted into the analysis device, analysis should be performed. There is an effect that the body fluid does not come into contact with the outside air before the analysis is performed, the possibility that the operator comes into contact with the collected body fluid is extremely reduced, and the handling is simplified.
Since the disposable inspection tool according to Patent Documents 1 and 2 described above is disposable, it is necessary to stock a certain amount. However, the sensor part deteriorates when left at room temperature for a long time. For this reason, it is usually stored in a refrigerator and returned to room temperature before use. However, since it takes time to return to the normal temperature after taking it out of the refrigerator, in general, take out the amount of disposable inspection tools that will be used up in a few days from the refrigerator in advance and return to normal temperature. But I am trying to use it.
However, in such a usage, the management of the disposable inspection tool taken out of the refrigerator becomes very troublesome. That is, if there are too many items out of the refrigerator, the disposable inspection tool will not be used without being used up within the scheduled number of days. On the other hand, if there are too few items left in the refrigerator, there will be insufficient disposable inspection tools that can be used immediately. Blood pH and blood gas analysis is a clinical test item performed for patients who need to perform changes in minute order and perform changes in minute order, and are performed for pathologic evaluation of respiratory function. . In other words, because it is an urgent laboratory test item, it cannot be predicted in advance that there will be patients to be measured, it may be rarely used when not in use, and suddenly a large amount must be used It is also an inspection item that occurs. Moreover, it must be measured immediately when it is desired to measure, and it is necessary to measure in as short a time as possible. Therefore, it is necessary to measure from the state of normal temperature, and if all are removed from the refrigerator and incubated, the use is limited. If it is necessary to measure a large amount suddenly, if you take it out of the refrigerator and use it immediately, the accuracy of the measurement cannot be ensured and the purpose of the clinical test cannot be achieved. It becomes necessary to wait until the temperature is reached.
In order to solve such a problem, the present invention can be used in the same manner whether it is a disposable inspection tool immediately after being taken out of the refrigerator or a disposable inspection tool being taken out of the refrigerator and returned to room temperature. It is an object of the present invention to provide an analysis apparatus that can perform the above-described analysis.

  In order to achieve the above-described object, a body fluid analyzer according to the present invention includes a body fluid introduction hole, a body fluid passage extending from the body fluid introduction hole, and a sensor unit capable of detecting at least one component of the body fluid supplied from the body fluid passage. A body fluid analyzer that analyzes a component in body fluid via a sensor part of the disposable inspection tool, the insertion part into which the disposable inspection tool can be inserted, and the insertion A temperature measurement unit capable of measuring the temperature of the sensor unit of the disposable inspection tool inserted from the unit, an input unit for inputting an output of the sensor unit of the disposable test tool inserted from the insertion unit, and the sensor unit A heating means capable of heating, and a control means for performing analysis processing of components in body fluid based on the output from the sensor unit and controlling the heating means based on the output from the temperature measurement unit If the temperature of the sensor unit obtained by the temperature measurement unit is lower than a predetermined temperature when the sensor unit is inserted from the insertion unit, the control unit performs the heating before performing the analysis process. The sensor is preheated until the temperature of the sensor unit reaches a predetermined temperature by operating the means.

  A body fluid analyzer according to the present invention inserts a disposable test tool having a body fluid introduction hole, a body fluid passage extending from the body fluid introduction hole, and a sensor unit capable of detecting at least one component of the body fluid supplied from the body fluid passage. A body fluid analyzer for analyzing a component in body fluid via a sensor part of the disposable inspection tool, the insertion part capable of inserting the disposable inspection tool, and a disposable inspection tool inserted from the insertion part. A temperature measurement unit capable of measuring the temperature of the sensor unit; an input unit for inputting an output of the sensor unit of the disposable inspection tool inserted from the insertion unit; a heating unit capable of heating the sensor unit; and the sensor And a control means for controlling the heating means on the basis of the output from the temperature measuring section. The control means comprises the sensor. When the temperature of the sensor unit obtained by the temperature measurement unit is lower than a predetermined temperature when the unit is inserted from the insertion unit, the heating unit is operated before performing the analysis process, Since the sensor unit is preheated until the temperature reaches a predetermined temperature, if the inspection tool is immediately after being taken out of the refrigerator, the analysis process is performed after the preheat treatment. In the case where is returned to room temperature, the analysis process is performed without performing the pre-heat treatment. Therefore, management of the inspection tool becomes easy, and problems such as a shortage of sensors that can be used immediately at the time of use do not occur.

It is a disassembled perspective view of the disposable test tool used for the body fluid analyzer which concerns on this invention. It is an expansion | deployment perspective view of the disposable test | inspection tool shown in FIG. In the figure, the partition plate 2 is omitted. It is a perspective view of the disposable test | inspection tool shown in FIG. 1 is a schematic perspective view of a body fluid analyzer according to the present invention equipped with a disposable inspection tool 1. FIG. It is a schematic block diagram which shows the internal structure of a bodily fluid analyzer.

Embodiments of a body fluid analyzer according to the present invention will be described below with reference to the accompanying drawings.
FIG. 1 is an exploded perspective view of a disposable inspection tool used in the body fluid analyzer according to the present invention.
As shown in the drawings, the disposable inspection tool 1 is made of a suitable material such as a transparent or translucent plastic material, and is sandwiched between two substrates 1A, 1B and substrates that are superposed on each other, and has an adhesive layer on both sides. The two substrates 1A and 1B are liquid-tightly joined to each other by the thin partition plate 2 when assembled.

One substrate 1A has a body fluid passage 3 formed of a groove through which a body fluid of a human or animal to be examined is passed, as shown in FIG. 1, on the inner surface thereof, that is, the surface facing the thin partition plate 2. It is formed in a U shape along the part. One end of the body fluid passage 3 communicates with the body fluid introduction hole 4, and the other end of the body fluid passage 3 communicates with the first body fluid storage section 5 formed of a groove formed on the inner surface of the substrate 1A.
As shown in the figure, the grooves constituting the first body fluid storage unit 5 are bent and arranged, and the width and depth thereof are the width and depth of the grooves constituting the body fluid passage 3 in order to obtain a sufficient volume. It is set larger than this.
Further, as shown in the figure, the body fluid passage 3 has a relatively narrow portion 3a extending from the body fluid injection hole 4, a sensor contact portion 3b following the relatively narrow portion 3a, and a sensor contact portion 3b. A constricted portion 3c and a portion 3d extending from the constricted portion 3c to the groove of the first body fluid storage unit 5 are provided. A narrow groove 6 constituting a part of the reagent passage is formed inwardly at a portion of the passage 3 adjacent to the relatively narrow portion 3a of the sensor contact portion 3b.
Further, a branch passage 7 extending toward the peripheral edge is formed in the sensor contact portion 3 b of the body fluid passage 3, and its tip ends at a through hole 8. The through-hole 8 is positioned so as to face a reference electrode described later, and can be filled with a gel-like saturated potassium chloride solution.
Further, an opening 9 is formed in an inner region surrounded by the U-shaped passage 3 of one substrate 1A, and this opening 9 receives a means for pressing a reagent container described later at the time of measurement. Is provided.
Furthermore, a through-hole 15 for guiding and locking when the disposable inspection tool is inserted into the body fluid analyzer according to the present invention is provided in the substantially central portion of the one substrate 1A.

A recess 12 is formed at one corner of the inner surface of the other substrate 1 </ b> B, that is, the surface facing the thin partition plate 2. As shown in FIG. 2, the sensor substrate 11 constituting the sensor unit and the heating substrate 10 for heating the sensor unit are mounted on the recess 12 with the heating substrate 10 facing down. .
Further, a mounting concave surface 14 of the calibration liquid container 13 is formed at a position corresponding to the opening 9 of one substrate 1A in the substrate 1B. A round recess is formed in the center of the bottom of the mounting concave surface 14 and protrudes inward in the center. When the calibration liquid container 13 is pressed by the pressing means 36 of the body fluid analyzer described later, the calibration liquid A needle-like body for piercing the container 13 is integrally provided.
Reference numeral 16 denotes a second bodily fluid storage unit including a bent groove provided symmetrically with the first bodily fluid storage unit 5 at a position corresponding to the first bodily fluid storage unit 5 on one substrate 1A. Yes.
The calibration solution container 13 is filled with a reagent for calibrating each sensor on the sensor substrate 11, and this calibration solution container 13 is pressed by the pressing means through the opening 9 when the sensor is calibrated prior to measurement. It is made of a material that can be easily punched when pressed against the needle-like body, and as an example, it can be preferably made in a foil pack shape.
The substrate 1B has a narrow groove that forms part of the reagent passage from a round recess at the center of the bottom of the mounting concave surface 14 to a position corresponding to the free end of the narrow groove 6 that forms part of the reagent passage on one substrate 1A. 17 is formed.
The sensor substrate 11, by applying a conductive ink onto a substrate to form a plurality of electrodes 11b, each electrode 11b, acidity PH, carbon dioxide partial pressure PCO _2, the oxygen partial pressure PO _2, sodium Na, potassium Various gas concentrations such as K, chlorine Cl, ionized calcium Ca, urea nitrogen BUN, glucose Glu, hematocrit Hct, bicarbonate ion HCO ₃₋ , oxygen saturation SO ₂ , total carbon dioxide TCO ₂ , excess base BE, and hemoglobin Hgb And a sensor 11c for measuring the ion concentration.
Each sensor 11c can use its own existing one, and is configured to detect as a voltage value or a current value, and a detailed description thereof will be omitted.
Each electrode 11b is connected to a terminal 11e arranged in alignment along one side edge of the substrate 11a through a conductor 11d, and these terminals 11e are connected to two substrates 1A with a thin partition plate 2 interposed therebetween. When 1B is fixed to each other, it is exposed. That is, as can be seen from FIG. 3, the width of one substrate 1A is slightly smaller than that of the other substrate 1B, thereby exposing each terminal 11e on the other substrate 1B.
As shown in FIG. 2, the sensor substrate 11 has one corner portion cut out, and when the sensor substrate 11 is arranged so as to overlap the heating substrate 10, the sensor substrate 11 is heated from the portion where the corner portion is cut out. The terminal 10a of the circuit board 10 is configured to be exposed. The heating substrate 10 is provided with a conductor 10b having an appropriate resistance value so as to generate heat when a current of a predetermined value is supplied from the body fluid analyzer through the terminal 10a.

  The start end 16a of the groove constituting the second bodily fluid storage unit 16 communicates with the terminal end 5a of the first bodily fluid storage unit 5 in the one substrate 1A through the communication hole 18 in the partition plate 2, and the second A hole 19 that communicates with the outside is provided at the end 16b of the groove of the body fluid storage section 16, and this hole is a plug member made of a material that is permeable to air and impermeable to liquid (see FIG. The body fluid injected during use flows into the first and second body fluid storage sections through the body fluid passage 3 and prevents the body fluid that has flowed in from leaking outside. A through hole 20 is provided at a position on the other substrate 1B corresponding to the through hole 15 in one substrate 1A. When the two substrates 1A and 1B are bonded to each other, the through holes 15 and 20 are aligned. It is made to agree.

The partition plate 2 is provided with a plurality of openings 21 at positions along the sensor contact portion 3b and the branch passage 7 of the passage 3 in one substrate 1A, and the sensor contact portion 3b and the branch passage of the passage 3 are provided. The body fluid that flows to 7 is in contact with each sensor 11c and electrode 11b on the other substrate 1B through these openings 21.
Further, the partition plate 2 includes a hole 22 provided at a position corresponding to the through hole 10 on one substrate 1A and the through hole 20 on the other substrate 1B, the free end of the narrow groove 6 on one substrate 1A, and the other substrate. A hole 23 for communicating with the free end of the narrow groove 17 on 1B, and a hole 25 or an easily breakable portion 26 provided at a position corresponding to the opening 9 in one substrate 1A are provided.

Next, with reference to FIG.4 and FIG.5, the structure of the bodily fluid analyzer which concerns on this invention which uses the disposable inspection tool 1 mentioned above is demonstrated.
FIG. 4 is a schematic perspective view of a body fluid analyzer equipped with the disposable inspection tool 1, and FIG. 5 is a schematic block diagram showing the internal structure of the body fluid analyzer. FIG. 5 is a schematic block diagram of the body fluid analyzer in a state in which the disposable inspection tool is mounted, and the disposable inspection tool is shown in cross section.
In the figure, reference numeral 30 denotes a body fluid analyzer, and reference numeral 31 denotes a casing of the body fluid analyzer. As shown in the drawing, the body fluid analyzer 31 has an insertion port 32 of the disposable inspection tool 1 on the front surface of the casing 31, and the upper surface portion of the casing 31 is configured with a touch panel so as to function as an operation unit. A monitor 33 and a printer 34 are provided.
The casing 31 has a
A temperature sensor 35 (temperature) arranged at a position corresponding to the upper part of the sensor part of the inserted inspection tool 1 so as to measure the temperature of the sensor part of the inserted inspection tool 1, that is, the sensor substrate 11 in a non-contact manner. Measuring section)
A pressing means 36 disposed at a position corresponding to the upper portion of the opening 9 of the inserted inspection tool 1;
A locking pin 37 disposed at a position corresponding to the upper side of the through hole 15 of the inserted inspection tool 1;
A terminal portion 38 connected to the sensor terminal 11d of the inspection tool 1, a terminal portion 39 connected to the terminal 10a of the heating substrate,
An operation signal from the monitor 33 constituted by the temperature sensor 35, the locking pin 37, and the touch panel is input, and the pressing means 36 and the heating substrate 10 are operated based on the input information, and input from the sensor terminal 11d. And a control means 40 for performing calculations related to body fluid based on the information.
The locking pin 37 is locked to the through-hole 15 of the test tool 1 when the test tool 1 is inserted to an appropriate position from the insertion port of the casing of the body fluid analyzer, and a lock signal is sent to the control means 40. The controller 40 is configured to output the signal, and the control means 40 operates using a locking signal from the locking pin 37 as a trigger.
When the inspection tool 1 is inserted into the body fluid analyzer, the control means 40 starts measuring the temperature of the sensor substrate 11 by the temperature sensor 35. The control means 40 inputs the measurement result of the temperature sensor 35. When the temperature of the sensor substrate 11 is lower than a predetermined temperature, a current is supplied to the heating substrate 10 via the terminal portion 39 for heating. As a result, the sensor substrate 11 is heated. When the temperature of the sensor substrate 11 exceeds a predetermined temperature due to the heat generation of the heating substrate 10, the control device 40 stops supplying current to the heating substrate 10 and activates the pressing means 36 to The calibration liquid container 13 is pressed downward from above. As a result, the calibration liquid container 13 is pierced by the needle-like body, the internal calibration liquid is pushed out, and the calibration liquid is pushed into the reagent passage through the grooves 6 and 17 and reaches the sensor substrate 11. Here, the control device 40 calibrates the sensor unit with the calibration liquid, and then causes the monitor 3 to display a display prompting the introduction of the body fluid from the body fluid introduction hole.
When the user introduces body fluid from the body fluid introduction hole according to the display on the monitor 3, the body fluid flows through the reagent passage and reaches the sensor substrate 11. Here, the control device 40 performs a component analysis of the body fluid based on the signal from the sensor unit, stores the analysis result in an appropriate storage means, and displays it on the monitor 3 as necessary. 4 to output.

1A, 1B Substrate 2 Thin partition plate 3 Body fluid passage 4 Body fluid introduction hole 5 First body fluid storage portion 6 Narrow groove constituting part of reagent passage 7 Branch passage 8 Through hole 9 Opening portion 10 Heating substrate 10a Terminal 10b Conductor 11 Sensor substrate 11a Substrate 11b Electrode 11c Sensor 11d Conductor 11d Terminal 12 Concave surface 13 Calibration liquid container 14 Mounting concave surface 15 Through hole 16 Second bodily fluid storage portion 17 Narrow groove forming part of reagent passage 18 Communication hole 19 Hole DESCRIPTION OF SYMBOLS 20 Through-hole 21 Several opening part 22 Hole 23 Hole 25 Hole 26 Easy breakable part 30 Body fluid analyzer 31 Casing 32 Insertion part 33 Monitor 34 Printer 35 Temperature sensor 36 Pressing means 37 Locking pin 38 Terminal part 39 Terminal part 40 Control apparatus

Claims (5)

A sensor for the disposable inspection tool is inserted by inserting a disposable inspection tool having a body fluid introduction hole, a body fluid passage extending from the body fluid introduction hole, and a sensor unit capable of detecting at least one component of the body fluid supplied from the body fluid passage. A body fluid analyzer for analyzing components in the body fluid through a section,
An insertion part into which the disposable inspection tool can be inserted;
A temperature measurement unit capable of measuring the temperature of the sensor unit of the disposable inspection tool inserted from the insertion unit;
An input unit for inputting the output of the sensor unit of the disposable inspection tool inserted from the insertion unit;
Heating means capable of heating the sensor unit;
And a control means for controlling the heating means based on the output from the temperature measurement section, while performing analysis processing of components in body fluid based on the output from the sensor section,
The control means is
When the temperature of the sensor unit obtained by the temperature measurement unit when the sensor unit is inserted from the insertion unit is lower than a predetermined temperature, the heating unit is operated before the analysis process is performed, and the sensor A body fluid analyzer characterized in that the sensor section is preheated until the temperature of the section reaches a predetermined temperature. The body fluid analyzer according to claim 1, wherein the temperature measuring unit is a non-contact temperature sensor. The body fluid analyzer comprises an insertion detection means for detecting whether or not a disposable inspection tool has been inserted from the insertion portion,
The body fluid analyzer according to claim 1 or 2, wherein the body fluid analyzer is configured to operate when the insertion detection means detects the insertion of a disposable test tool. The disposable inspection tool includes a calibration liquid storage unit that stores a calibration liquid for calibrating the sensor unit,
Body fluid analyzer
A pressing means for pressing the calibration liquid container of the disposable inspection tool and pushing the calibration liquid from the calibration liquid container to the sensor unit;
The control device is
When the temperature of the sensor unit obtained by the temperature measurement unit is lower than a predetermined temperature when inserted from the insertion unit, the heating unit is first operated until the temperature of the sensor unit reaches the predetermined temperature. Pre-heat the sensor unit, then operate the pressing means to calibrate the sensor unit, and then perform the analysis process,
When the temperature of the sensor unit obtained by the temperature measurement unit when inserted from the insertion unit is higher than a predetermined temperature, the sensor unit is operated by operating the pressing unit without performing the pre-heat treatment by the heating unit. The body fluid analyzer according to any one of claims 1 to 3, wherein the body fluid analyzer is configured to calibrate and then perform the analysis process. The body fluid analyzer comprises display means for displaying information related to the operation to the user,
After the control device operates the pressing means to calibrate the sensor unit and before executing the analysis process by the analysis processing unit, a display prompting the introduction of body fluid from the body fluid introduction hole is displayed. The body fluid analyzer according to claim 4, wherein the body fluid analyzer is configured to be displayed on a display unit.

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