JP3604819B2 - Body fluid analyzer - Google Patents

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a body fluid analyzer capable of analyzing a substance to be detected contained in a body fluid such as a blood glucose level, and more particularly to a body fluid analyzer capable of automatically and continuously performing a series of steps.
[0002]
[Prior art]
2. Description of the Related Art Conventionally, when measuring a blood glucose level or the like, a finger, upper arm, abdomen, buttocks, etc. were scratched using a puncture device (lancet), blood droplets were squeezed out therefrom, taken out of a packaging material, and attached to a sensor. This has been done by attaching the blood drop to the electrode.
However, it is very troublesome to squeeze out the necessary amount of blood droplets for measurement, and if the puncture device and sensor are separated, there are many operations required by the measurer in performing a series of processes, There is a problem that the measurement is complicated.
[0003]
In addition, when puncturing with a puncture device or when squeezing out a blood drop, blood may be scattered, contaminating surrounding parts at the time of measurement, or causing a fear of the measurer.
[0004]
[Problems to be solved by the invention]
An object of the present invention is to provide a body fluid analyzer capable of performing a series of steps required for measurement automatically and continuously, without giving a fear to a measurer, and capable of performing a sanitary measurement. It is to be.
[0005]
[Means for Solving the Problems]
In view of the above problems, as a result of intensive studies, the present inventors have found that a puncture means, a compression band (cuff) for discharging bodily fluid from a punctured finger and its pressurizing means, and information about the discharged bodily fluid into an electric signal. A unit for converting, a means for determining a measured value based on the electric signal, a display for displaying the determined measured value, and the like are housed in one device, and a series of steps required for the measurement are automatically and continuously controlled by a computer. It is possible to perform the analysis of the bodily fluid easily and quickly, and by providing a cover so that the bodily fluid discharged to the puncturing means is not scattered, it is possible to give fear to the measurer. The present invention was found to be possible and to perform hygienic measurements, and completed the present invention.
[0006]
That is, the present invention provides puncturing means for puncturing a finger, a compression band (cuff) for compressing the finger, pressurizing means for supplying air to the cuff, and exhaust means for exhausting air from the cuff. A means for converting information relating to bodily fluid discharged from a finger into an electrical signal, a means for determining a measured value based on the electrical signal, and a display for displaying the determined measured value; The body fluid analyzer is characterized in that the puncture means is provided with a cover so that the discharged body fluid does not scatter.
Further, the present invention is a body fluid analyzer in which a pressure sensor for detecting a pressure of a cuff is further added to the above body fluid analyzer.
[0007]
[Action]
Puncturing means for puncturing a finger, a cuff for compressing the finger, pressurizing means for supplying air to the cuff, exhaust means for exhausting air from the cuff, and information on bodily fluid discharged from the finger. According to the body fluid analyzer of the present invention having a means for converting to an electric signal, a means for determining a measured value based on the electric signal, and a display for displaying the determined measured value, after the finger is punctured, The body fluid is drained by pressing with a pressurized cuff, and after draining, the cuff is loosened by evacuation and the finger is opened, the necessary information from the obtained body fluid is converted into an electric signal and the measured value is determined, Since the information can be displayed on the display, a series of steps required for the measurement can be automatically and continuously performed, and the analysis of the body fluid can be performed simply and quickly.
[0008]
In addition, since the body fluid analyzer is provided with a cover on the puncturing means so that the discharged body fluid does not scatter, it is possible to remove the fear of the measurer about puncturing or blood, and to contaminate surrounding parts with body fluid. Without the need for sanitary measurements.
By adding a pressure sensor that detects the pressure of the cuff to the body fluid analyzer, the upper limit of the pressure of the cuff can be determined regardless of the thickness of the finger of the measurer, and gives the measurer an excessive feeling of pressure. An appropriate amount of bodily fluid can be squeezed out of the finger without the need.
[0009]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, the present invention will be described in detail with reference to the drawings.
Here, the body fluid in the present invention refers to a liquid that can be discharged from a living body by puncturing, such as blood or intercellular exudate.
FIG. 1 shows a perspective view of a body fluid analyzer according to an example of the present invention. The body fluid analyzer 1 has a rectangular parallelepiped casing 11, and the casing 11 includes a tightening portion 2, a puncturing portion 3 having a cover 6, a display 4, a main switch 51, and a puncturing switch 52. Is provided.
[0010]
The tightening portion 2 has a cylindrical shape so that a finger can be inserted therein, and a cuff (compression band) 21 for pressing the finger is provided inside the tightening portion 2. The cuff 21 can press and release a finger by using the injection and exhaust of air by a cuff driving device (not shown). The cuff driving device has a sensor (pressure sensor) for detecting the pressure of the cuff 21, a solenoid valve, a pump, and a leak valve, and these are communicated with the cuff 21 through a rubber tube. The cuff driving device is controlled by a computer (not shown) provided inside the body fluid analyzer 1.
[0011]
The puncture unit 3 has a cover 6 and a plate-like base 7 housed in the cover 6 as shown in FIG. A puncturing blade 71 is provided on one side of the base 7 so as to be able to move forward and backward (see FIGS. 3A and 3B), and an electrode tip 72 is provided on the other side. Electrode leads 73a and 73b are provided so as to be connected to the terminals of the electrode chip 72 (see FIG. 3 (c)). Further, leaf springs 74 are provided on both front sides of the base 7, and the protruding puncture blade 71 can be retracted to the initial position. FIG. 3D is a perspective view of the base 7 and the puncture blade 71 as viewed from the rear.
[0012]
The puncture blade 71 is preferably made of stainless steel in consideration of hygiene safety, and a commercially available puncture blade 71 such as Blood Lancets manufactured by Feather Safety Razor can be used. In addition, although the puncture blade is used in the present embodiment, the present invention is not limited to this, and may be anything as long as it can injure the skin and discharge body fluids, For example, it may be needle-shaped (puncture needle).
[0013]
One of the electrodes of the electrode tip 72 is coated with an enzyme ink (not shown). Various types of enzyme inks can be selected according to the substance to be detected in the body fluid.For example, when measuring a blood sugar level, an ink composition containing glucose oxidase or the like can be used, or To measure the medium cholesterol level, an ink composition containing cholesterol oxidase or the like can be used.
[0014]
The cover 6 for accommodating the base 7 has a substantially cylindrical shape as shown in FIG. 4 (a), but the finger placed on the body fluid analyzer 1 A recess 61 is provided to fit (see FIG. 4B).
FIG. 5 shows a side view of the cover 6. The length (L) and the diameter (D) of the cover 6 depend on the size of the base 7 and the puncture blade 71 to be used, but the length (L) is 10 to 60 mm, particularly 50 mm, and the diameter (D) is 5 It is preferably from 30 to 30 mm, particularly preferably 20 mm. The recess 61 is preferably recessed in a semicircle, and the radius (R) of the circle is preferably 2 to 15 mm, particularly preferably 8 mm. The concave portion 61 and the end portion 62 of the cover 6 are preferably continuous in a curved line, and the curved line is preferably formed by a circular arc having a radius (r) of 0.5 to 5 mm, particularly 2 mm.
[0015]
The material of the cover 6 is not particularly limited as long as it is a polymer that can be sterilized and is generally used, such as polyethylene, polystyrene, polypropylene, and Teflon. Also, the thickness of the cover 6 is not particularly limited as long as it does not significantly deform during use, and is usually preferably about 0.5 to 3 mm. The cover 6 may be opaque so that the body fluid or the puncture blade 71 is not directly visible, or may be transparent so that the body fluid or the puncture blade 71 is directly visible. Further, the translucent body may be made translucent red so that the body fluid (blood) is not visible but the operation of the puncture blade 71 can be seen. Is also good. The fear of the puncture or blood that the measurer has may vary, and may be appropriately designed according to the needs of these persons.
[0016]
In order to make the cover 6 transparent to translucent to opaque, the transparency can be adjusted by, for example, changing the mixing ratio of calcium carbonate kneaded into the resin before molding, and for example, a magenta dye is appropriately mixed with the resin. By doing so, a red cover can be obtained.
If the cover 6 accommodating the base 7 having the puncture blade 71 and the electrode tip 72 is made into a cartridge type that can be removed from the body fluid analyzer 1, they can be disposable, which is very advantageous in terms of hygiene. .
[0017]
The puncture blade 71 is advanced (see FIG. 2) by driving a puncture blade driving device (in this embodiment, a solenoid) 9 via the arm member 8. The solenoid 9 is driven by turning on the puncture switch 52. The tip portion of the puncturing blade 71 that has been advanced projects from the base 7 and reaches a position ahead of the electrode tip 72. The amount of protrusion of the puncture blade 71 from the electrode tip 72 is such that the finger can be punctured and drained while the finger is attached to the body fluid analyzer 1, and the discharged body fluid comes into contact with the electrode tip 72. What is necessary is just to set so that it may be obtained. Specifically, it is preferably from 100 to 2000 μm, particularly preferably 750 μm. The protruding puncture blade 71 is retracted to the initial position by the action of the leaf spring 74 provided on the base 7. In this embodiment, the solenoid is used as a method for driving the puncture blade. However, the present invention is not limited to this, and the puncture blade can be driven by various methods.
[0018]
FIGS. 6A and 6B show the relationship between the puncture blade 71 and the electrode tip 72 and the cover 6. It is preferable that the tip surface of the electrode tip 72 be flush with the surface of the most concave portion in the concave portion 61 of the cover 6. The protrusion amount of the puncture blade 71 is preferably 100 to 2000 μm, particularly preferably 750 μm from the most concave portion in the concave portion 61.
[0019]
On the other hand, the relationship between the cover 6 and the casing 11 is shown in FIG. FIG. 7 is a sectional view of the body fluid analyzer 1 taken along the line AA in FIG. In this embodiment, the cover 6 protrudes sufficiently outward from the concave portion 110 of the casing 11, but the present invention is not limited to this, and the most concave portion in the concave portion 61 of the cover 6 is the concave portion 110 of the casing 11. It just needs to be outside.
[0020]
FIG. 8 is a block diagram showing an example of a circuit configuration of the body fluid analyzer.
In this body fluid analyzer, the cuff 21 communicates with a pressure sensor, an electromagnetic valve, a pump, and a leak valve by a rubber tube, and these constitute a pneumatic system. The operation of each member in the body fluid analyzer is controlled by a computer. The computer has a function to turn on / off a solenoid valve, a leak valve and a pump, a function to capture air pressure data detected by a pressure sensor, a function to operate a solenoid, a function to capture an electric signal from an electrode, and a function to calculate an electric signal. It has a function of determining a measured value and a function of outputting the measured value to a display.
[0021]
This computer is initialized when the main switch 51 is turned on, drives the solenoid 9 when the puncture switch 52 is turned on, and is programmed to drive the pump after a predetermined time. In addition, the pump may be turned off and the solenoid valve and the leak valve may be opened by taking in information that the pressure of the cuff 21 or the body fluid that has been detected by the pressure sensor has come into contact with the electrode, or after a predetermined time has elapsed since the pump was turned on. Command. The electric signals from the electrodes are also taken into the computer, and the measured values determined by the computer are output to the display 4.
Note that this circuit configuration is merely an example, and a pressure sensor may not be necessary in some cases.
[0022]
An example of the detailed operation of the body fluid analyzer in FIG. 1 will be described with reference to the flowchart shown in FIG.
Before starting the measurement, the measurer inserts a finger into the cuff 21. The finger may be any finger, or may be a finger on either the left or right hand. When the main switch 51 is turned on, the system is initialized such as clearing the memories in the computer.
[0023]
Next, the measurer turns on puncture switch 52. When the puncture switch 52 is turned on, the solenoid 9 is driven, and the puncture blade 71 projects from the base 7 via the arm member 8 (step 1). The protruding puncture blade 71 damages the skin of the finger, but at this time, the body fluid may jump out. However, since the cover 6 is provided on the puncture portion 3 of the present invention, it is possible to prevent contamination of the surrounding area due to scattering of body fluid. The punctured blade 71 returns to its original position by the action of the leaf spring 74. After the puncture blade 71 projects, the pump is driven (step 2), and the cuff 21 is pressurized. The cuff 21 compresses a finger and squeezes body fluid from the damaged skin. At this time, the bodily fluid may jump out. However, similarly to the above, the cover 6 can prevent the bodily fluid from being contaminated.
[0024]
There are three methods for determining whether to turn off the pump. First, when the apparent blood pressure reaches a predetermined value (P) due to, for example, the pressure of the cuff, the determination is YES (FIG. 9: step 3). Note that the apparent blood pressure refers to a transient blood pressure value displayed from the pressure sensor in the process of pressing the finger with the cuff. That is, an apparent blood pressure that directly reflects the cuff pressure can be detected by the pressure sensor. The value of P is desirably 120 mmHg or more, and about 180 mmHg can obtain the most appropriate amount of liquid. According to the first method, the upper limit of the cuff pressure can be determined regardless of the thickness of the finger of the measurer, and the body fluid can be squeezed out without giving the measurer an excessive feeling of pressure.
[0025]
Second, when a predetermined time (T) has elapsed since the pump was turned on, the determination is YES (FIG. 10: step 3 '). The value of T is preferably about 5 to 60 seconds, and about 20 seconds can obtain the most appropriate amount of liquid.
Third, when the squeezed body fluid comes into contact with the electrode, the determination is YES (FIG. 11: step 3 "). According to the third method, a necessary and sufficient amount of body fluid can be secured and excess The finger is not unduly pressed by the pressure, and the pressure sensor is not required when the second method and the third method are applied in this step.
[0026]
When the drive of the pump is stopped according to the determination by any one of the first to third methods (FIG. 9: step 4), the solenoid valve and the leak valve are opened immediately, and the air in the cuff is quickly exhausted (step 5). ). One valve may be used, but by using the electromagnetic valve and the leak valve together, the air in the cuff can be quickly exhausted, and the finger of the measurer can be released from the compressed state.
[0027]
The squeezed body fluid comes into contact with the electrode on the electrode tip 72, and information on the body fluid is sent to the computer as an electric signal to start the calculation (step 6). When the time t has elapsed from the start of the calculation (step 7), the calculation is terminated (step 8). Since a certain time is required for the measured value to stabilize, the value of t greatly depends on the performance of the electrode, but generally requires about 5 to 60 seconds. When the measured value is determined by the calculation by the computer, the measured value is displayed on the display 4 (step 9).
[0028]
According to the body fluid analyzer of the present invention described above, a series of operation steps can be reduced, and the inspection can be completed extremely easily and hygienically. In addition, since the present apparatus is provided with all of a puncture unit, a cover thereof, a pressurizing unit, a unit for converting information on body fluid into an electric signal, a unit for determining a measured value, and a display for displaying the measured value, The user does not need to be skilled, can use it easily and quickly, and can suppress fear of general users about puncturing and the like. Furthermore, the body fluid analyzer of the present invention can analyze not only the blood sugar level but also various substances in the body fluid by changing the type of the enzyme ink used.
[0029]
Although the present invention has been described in detail with reference to the drawings, the present invention is not limited thereto, and various modifications can be made without departing from the spirit of the present invention. For example, by making the display part rotatable with respect to the apparatus main body, the display can be oriented in a desired direction, and measurement can be easily performed. Further, the present invention is not limited to a finger, and may be applied to a device for a wrist, an arm or the like. Furthermore, it is also possible to provide an audio guide for the blind and to change the system to a series of systems until the measurement result is heard with a single switch.
[0030]
【The invention's effect】
ADVANTAGE OF THE INVENTION According to the apparatus of this invention, while a series of processes required for a measurement can be performed automatically and continuously, a fearlessness is not given to a measurer, and the analysis of a bodily fluid is simply and quickly performed hygienically. Can be done.
[Brief description of the drawings]
FIG. 1 is a perspective view showing an example of a body fluid analyzer of the present invention.
FIG. 2 is a view showing a cover, a base, a puncturing blade, and a puncturing blade driving device (solenoid) in the body fluid analyzer of the present invention.
FIG. 3 is a view showing a base, a puncture blade and an electrode tip in the body fluid analyzer of the present invention. (A) is a view as seen from the puncture blade side, (b) is a view showing a state where the puncture blade is projected, (c) is a view as seen from the electrode tip installation side, and (d) is a rear view. FIG.
FIG. 4 is a perspective view showing a cover in the body fluid analyzer of the present invention. (A) shows a state where the finger is not placed, and (b) shows a state where the finger is placed.
FIG. 5 is a side view of a cover in the body fluid analyzer of the present invention.
FIG. 6 is a diagram showing a positional relationship among a cover, a puncture blade, and an electrode tip in the body fluid analyzer of the present invention. (A) is a side view, (b) is a top view.
FIG. 7 is a sectional view taken along the line AA in the body fluid analyzer of FIG. 1;
FIG. 8 is a block diagram showing an example of a circuit configuration of the body fluid analyzer of the present invention.
FIG. 9 is a flowchart showing an example of the operation of the body fluid analyzer in FIG. 1;
FIG. 10 is a diagram showing another example of step 3 in the flowchart of FIG. 9;
FIG. 11 is a diagram showing another example of step 3 in the flowchart of FIG. 9;
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 ... Body fluid analyzer 11 ... Casing 110 ... Recess 2 ... Tightening part 21 ... Cuff 3 ... Puncturing part 4 ... Display 51 ... Main switch 52 ... Puncturing switch 6 ... Cover 61 ... Recess 62 ... End 7 ... Base 71 ... Puncture Blade 72 ... Electrode tips 73a, 73b ... Electrode lead 74 ... Leaf spring 8 ... Arm member 9 ... Solenoid

Claims (2)

Puncturing means for puncturing a finger, a compression band for compressing the finger, pressurizing means for supplying air to the compression band, exhaust means for exhausting air from the compression band, and pressure of the compression band. A body fluid analyzer comprising: a pressure sensor for detecting; a unit for converting information relating to body fluid discharged from a finger into an electric signal; a unit for determining a measured value based on the electric signal; and a display for displaying the determined measured value. The puncture means is provided with a cover so that the discharged bodily fluid is not scattered. Puncturing means for puncturing a finger, a compression band for compressing the finger, pressurizing means for supplying air to the compression band, exhaust means for exhausting air from the compression band, and body fluid discharged from the finger A body fluid analyzer having a means for converting information regarding an electrical signal, a means for determining a measured value based on the electrical signal, and a display for displaying the determined measured value. A body fluid analyzer, wherein a cover is provided to prevent the scattered body fluid from scattering.

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