JP2000152923A - Component measuring device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a sanitary component measuring device with improved safety which can continuously pierce a body surface, draw a humor (blood)from a vein, and measure the components of the humor without splashing the humor. SOLUTION: This component measuring device 1A has the main body 2, a lid 27 rotatably attached to the main body 2, a piercing means 3 with a needle 12 to pierce the body surface, a pressure reducing means 5 for keeping the pierced part by the needle 12 in a reduced pressure condition, a link mechanism 6, a reduced pressure releasing means 7 for releasing the reduced pressure condition by the pressure reducing means 5, an operating means 8, and a measuring means for measuring a prescribed component such as glucose included in the subject (blood). When the lid 27 is opened, a plunger 50 for pressure reduction is pressed toward the top by the operation of the link mechanism 6, a second engagement part 54 being engaged with a claw 82, so that spaces 262 and 261 are in the pressure reducible condition.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an apparatus for measuring a component, and
Specimen (blood) by puncturing the surface of a living body such as a fingertip with a puncture needle
And a component measuring device for measuring the amount of a specific component such as glucose in the sample.

[0002]

2. Description of the Related Art In recent years, with the increase in the number of diabetic patients, autologous blood glucose measurement in which patients monitor daily fluctuations in blood glucose levels has been recommended.

In order to measure the blood sugar level, a test paper which develops a color according to the amount of glucose in the blood is mounted, blood is supplied to the test paper, the color is developed and developed, and the degree of the color development is measured optically. The measurement is performed using a blood glucose measuring device that measures (colorimeters) and quantifies the blood glucose level.

Prior to this measurement, as a method for a patient to collect his or her own blood, a patient's skin is punctured using a component measuring device equipped with a puncture needle or a scalpel, and the area around the puncture is pressed with a finger or the like. The blood is then squeezed out.

[0005] However, the fingertips are concentrated in capillaries and are suitable for collecting blood. On the other hand, since nerves are concentrated and painful, the pain and burden on the patient are great. Because it involves fear,
Many patients are unable to continue their own blood glucose measurements.

Conventionally, since the component measuring device and the blood sugar measuring device are separate from each other, after puncturing by the component measuring device, the user has to switch to the blood sugar measuring device while the fingertip is bleeding, resulting in poor operability. It was disadvantageous in terms of hygiene.

[0007] Japanese Patent Laid-Open Publication No. Hei 6-339473 discloses an apparatus in which a component measuring device and a blood glucose measuring device are integrated. The blood glucose measurement device disclosed in this publication performs puncturing means, means for transferring blood to a blood chemical reagent, and optical measurement of the blood chemical reagent in a housing, and displays the result. It has display means.

However, in this blood glucose measuring device, the operation of opening the lid covering the site from which blood is to be collected, the preparation for puncturing with a puncture needle, and the operation of puncturing must be performed separately, and moreover, the puncturing is performed. However, since the amount of bleeding was insufficient, it was necessary to squeeze out the blood by squeezing with a finger or the like after puncturing, resulting in poor operability.

[0009]

SUMMARY OF THE INVENTION According to the present invention, puncture, collection of body fluid (blood) and measurement can be performed continuously with simple operation, and no bodily fluid is scattered. It is an object of the present invention to provide a component measuring device having high property.

[0010]

This and other objects are achieved by the present invention which is defined below as (1) to (17).

(1) A component measuring apparatus for measuring an amount of a predetermined component in a specimen using a test paper, comprising: a main body having a chip mounting portion for mounting a chip provided with the test paper; A lid body that is movably installed and covers the tip mounting portion when closed, and a puncture needle can be attached thereto, and puncture means for puncturing a specimen collection site with the attached puncture needle; and the puncture needle Pressure reducing means that can put the puncture site by the pressure reduction state, and measurement means for measuring the amount of a predetermined component in the sample spread on the test paper, and the pressure reduction is performed with the operation of opening the lid. A component measuring device, characterized in that it is arranged to prepare for activation of the means.

(2) The component measuring device according to (1), further comprising a display unit for displaying the measurement result, and covering the display unit when the lid is closed.

(3) The above (1) or (2) wherein the operation of the pressure reducing means and the operation of the puncturing means are performed in conjunction with each other.
The component measuring device according to 1.

(4) The component measuring apparatus according to any one of (1) to (3), further including an operating means for causing the depressurizing means and the puncturing means to operate substantially simultaneously or in a predetermined order.

(5) The component measuring apparatus according to any one of (1) to (4), wherein the puncturing means has an adjusting mechanism for adjusting a puncturing depth.

(6) The component measuring apparatus according to any one of (1) to (5), wherein the puncturing means has a puncturing plunger and a first urging means for urging the puncturing plunger.

(7) The puncture plunger has a first locking portion for restricting movement in the tip direction, and
The component measuring apparatus according to (6), wherein the component is moved in the distal direction by releasing the lock of the first locking portion while being urged by the urging means, and puncture is performed with a puncture needle.

(8) The component measuring device according to (6) or (7), wherein the direction of the operation for performing the puncture by operating the puncture plunger is different from the direction of movement of the puncture plunger. .

(9) The pressure reducing means includes a pressure reducing plunger provided with an airtight sealing member, and a second biasing means for biasing the pressure reducing plunger (1) to (8). The component measuring device according to any one of the above.

(10) The depressurizing plunger has a second locking portion for restricting the movement in the proximal direction, and the second locking portion is urged by the second urging means. The component measuring device according to the above (9), which moves in the proximal direction by releasing the locking of the component, and generates the reduced pressure state.

(11) The pressure reducing means has a pressure reducing plunger provided with an airtight sealing member, and a second biasing means for biasing the pressure reducing plunger. It has a second locking portion for restricting the movement in the proximal direction, and releases the locking of the second locking portion in a state where the second locking portion is urged by the second urging means so as to move in the proximal direction. Moving to cause the decompression state,
The component measuring device according to the above (7), which releases the locking of the locking portion.

(12) The component measuring apparatus according to any one of (1) to (11), wherein the pressure reducing means has a one-way valve.

(13) The lid is connected to a rotation shaft of the lid,
The component measuring device according to any one of (1) to (12), further including a transmission mechanism that transmits a rotational force of the rotating shaft to the pressure reducing unit.

(14) The above-mentioned (1) to (1) further comprising decompression releasing means for releasing the decompression state by the decompression means.
The component measuring device according to any one of 3).

(15) The component measuring apparatus according to any one of (1) to (14) above, wherein the puncture needle mounted on the puncturing means passes through the tip mounting section and punctures a sample collection site.

(16) The component measuring apparatus according to any one of the above (1) to (15), wherein the chip mounting portion has a sealing member for maintaining airtightness with the mounted chip.

(17) The component measuring device according to any one of (1) to (16), further including a power switch, wherein the power switch is turned on when the lid is opened.

[0028]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a component measuring apparatus according to the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

FIG. 1 is a perspective view showing an embodiment of the component measuring apparatus according to the present invention, and FIGS. 2 to 10 are sectional plan views showing the internal structure and operating state of the component measuring apparatus shown in FIG. 1, respectively. . 2 to 10, the right side is referred to as “proximal end” and the left side is referred to as “distal end”.

As shown in FIGS. 1 to 10, a component measuring device (blood component measuring device) 1A includes a main body 2, a lid 27 rotatably (openable and closable) with respect to the main body 2, Puncturing means 3 for puncturing the surface of a living body with a puncture needle, and decompression means 5 for putting a puncture site with the puncture needle into a reduced pressure state
, A link mechanism 6, a decompression releasing unit 7 for releasing the decompressed state by the decompression unit 5, an operating unit 8, and a measuring unit 13. Hereinafter, each of these components will be described.

The main body 2 has a housing 21, and a tip mounting portion 22 for detachably mounting a chip 9 to be described later is provided at the tip of the housing 21. The tip mounting portion 22 has an opening 221 through which the puncture needle 12 can pass.
Are formed.

The chip mounting portion 22 is provided with a seal ring (sealing member) 23 for maintaining airtightness between the chip 9 and the chip 9 when the chip 9 is mounted.

On the upper surface of the main body 2, there is formed a display section 14 composed of a liquid crystal display (LCD) or the like. In the display unit 14, for example, power on / off,
Power supply voltage (remaining battery level), measured values, measurement date and time, error display, operation guidance, and the like can be displayed.

At the base end of the main body 2, a plate-like lid 27 is rotatably supported by a shaft (rotating shaft) 29. The tip of the lid 27 is bent at a substantially right angle, and the bent portion constitutes a shielding portion 28 that covers the chip mounting portion 22 when the lid 27 is closed.

In the housing 21, a space 26 defined by the inner surface of the housing 21 and the walls 24 and 25 is provided.
1, 262, and these spaces 261, 262 include:
The puncturing means 3 and the decompression means 5 are stored respectively.

The puncturing means 3 includes a puncturing plunger 30,
A coil spring (first urging means) 35 for urging the puncture plunger 30 in the distal direction.

At the distal end of the puncture plunger 30, a cup-shaped needle holder 31 for mounting (fitting) the lancet 11 having the puncture needle 12 is provided. This needle holder 3
A lancet 11 is detachably attached to 1. An elastically deformable elastic piece 32 having a protruding first locking portion 33 at the distal end is provided at the base end of the puncture plunger 30.

The first locking portion 33 is urged upward in FIG. 2 by the elastic force of the elastic piece 32 and is in contact with the wall portion 24, but at the position of the opening 241 formed in the wall portion 24. When it comes,
It is inserted into the opening 241 and protrudes toward the space 262. This restricts the movement of the puncture plunger 30 in the distal direction. The space 261 and the space 262 communicate with each other via the opening 241.

On the side of the puncture plunger 30,
A pair of protrusions 34 are formed. Both protrusions 34 are inserted into guide grooves 42 formed in a fixing member 41 described later. Thereby, puncturing plunger 30 moves along guide groove 42.

The puncturing means 3 has an adjusting mechanism 4 for adjusting the puncturing depth of the puncturing needle 12. The adjusting mechanism 4 is mainly inserted into the space 261 and fixed to the housing 21, and a shaft fixedly connected to the base end of the puncture plunger 30 and inserted through the fixed member 41. 45 and a movable member 47 movable in the axial direction with respect to the fixed member 41.

A coil spring 35 is installed on the outer periphery of the distal end side of the shaft 45, and the proximal end of the coil spring 35 contacts the fixing member 41 via the spacer 43, and the distal end of the coil spring 35 is located on the proximal end of the puncture plunger 30. Is in contact with

The spacer 43 has a function of sliding the shaft 45 smoothly and reliably with respect to the fixing member 41.

When the first locking portion 33 is locked in the opening 241, the coil spring 35 is in a compressed state and urges the puncture plunger 30 toward the distal end. The coil spring 35 extends to move the puncture plunger 30 in the distal direction, and the elastic coefficient is such that the puncture needle 12 does not puncture the living body surface again while performing a damping movement after puncturing the living body surface. It is preferred that

Screws are formed on the outer periphery of the base end of the fixed member 41 and the inner periphery of the distal end of the movable member 47, respectively, and these are screwed together. In this case, the protrusions 44 formed on the outer peripheral surface of the base end portion of the fixed member 41 are formed on the inner peripheral surface of the distal end portion of the movable member 47 by a plurality of recesses 4 formed intermittently along the circumferential direction.
8, the movable member 47 can be positioned with respect to the fixed member 41.

At the base end of the shaft 45, a cap-shaped locking portion 4 is provided.
6 are formed. On the other hand, a stopper 49 is formed on the inner peripheral surface of the movable member 47 so as to protrude inward.
6 is locked to the stopper 49, so that the shaft 45
In addition, the movement of puncturing plunger 30 connected thereto in the distal direction is restricted.

Here, when the movable member 47 screwed to the distal end of the fixed member 41 is rotated in a predetermined direction, the movable member 4 is rotated.
7 moves in the axial direction with respect to the fixing member 41. By adjusting the rotation direction and the rotation amount of the movable member 47,
The position of the stopper 49 that determines the stop position of the plunger 30 in the distal direction is adjusted, and the maximum protrusion length of the puncture needle 12 from the opening 221, that is, the puncture depth of the puncture needle 12 into the specimen collection site can be adjusted. it can.

A seal ring (sealing member) 521 is fitted around the outer periphery of the base end of the movable member 47. Thereby, regardless of the position of the movable member 47 in the axial direction, the space 2
The airtightness of 61 is maintained, and the space 261 can be in a reduced pressure state.

The pressure-reducing means (suction means) 5 mainly comprises a pressure-reducing plunger 50, a coil spring 56 for urging the pressure-reducing plunger 50 in the proximal direction, a shielding member 57, and a one-way valve 59. Have been.

The depressurizing plunger 50 is a rod-shaped member, and has a gasket 51 at its tip. The gasket 51 has a seal ring (sealing member) 52 made of an elastic material on an outer peripheral portion thereof.

The seal ring 52 is airtightly adhered to the inner surfaces of the walls 24 and 25. When the plunger 50 moves in the axial direction, the seal ring 52
It slides in the same direction along the inner surfaces of the walls 24 and 25 while maintaining airtightness. In this case, the seal ring 52 preferably has a sliding resistance that does not hinder the expansion and contraction of the coil spring 56.

A flange 5 is provided between the walls 24 and 25.
5 is provided, and the pressure reducing plunger 50 is inserted through the center opening of the flange 55. This flange 55
Has a function of restricting the movement of the gasket 51 in the proximal direction, and also has a function as a spring seat of the coil spring 56.

A locking member 53 is fixed to the base end of the pressure reducing plunger 50. At the side end of the locking member 53,
A second locking portion 54 that regulates the movement of the depressurizing plunger 50 in the proximal direction is formed. The locking member 53
Has a function as a spring seat of the coil spring 56.

The coil spring 56 includes a plunger 50 for reducing pressure.
, And both ends thereof abut against the flange 55 and the locking member 53, respectively, and urge the depressurizing plunger 50 in the proximal direction by its elastic force.

The distal end of the space 262 is shielded by a shielding member 57. An air hole 58 is formed in the shielding member 57, and the cap-shaped one-way valve 5 is closed so as to close the air hole 58.
9 are installed. The one-way valve 59 is capable of discharging the air in the space 262 to the outside from the ventilation hole 58, but conversely, preventing the air from being introduced from the outside into the space 262 through the ventilation hole 58. It has.

A link mechanism (transmission mechanism) 6 for transmitting the rotational force of the shaft 29 to the plunger 50 for pressure reduction is connected to the shaft 29 of the lid 27.

The link mechanism 6 mainly includes the first link 6
1, a second link 62, and pins 63 and 64. One end of the first link 61 is fixed to the shaft 29,
The other end of the first link is connected to one end of the second link 62 and a pin 63
And are rotatably supported. The other end of the second link is rotatably supported by a pin 64 with respect to a piston 65 provided on the base end side of the locking member 53.

The piston 65 has a plunger 50 for reducing pressure.
In the state where the lid 27 is closed, it is located closest to the proximal end (see FIG. 2).
When the shaft 29 rotates due to the opening and closing operation of the lid 27, the rotational force is converted into linear motion of the piston 65 by the action of the link mechanism 6.

Also, within the turning radius of the first link 61,
The power switch 104 of the component measuring device 1A is provided. The power switch 104 is constituted by a touch switch, and as shown in FIG. 5, when the lid 27 is opened to a certain extent (a state in which the lid 27 is rotated by, for example, about 90 to 180 ° from the closed state), As a result, the first link 61 rotates by a predetermined angle, and the other end contacts the trigger of the power switch 104, and the power switch 104 is turned on. As a result, a state where measurement is possible is established.

As described above, since the operation of opening the lid 27 is linked with the power switch 104 and turns on the power switch 104, there is no need to perform an operation of turning on the power separately, and the operability is excellent.

The link mechanism 6 as described above has a simple structure and is advantageous for miniaturization of the apparatus, and is also advantageous in that the power transmission efficiency is good and the malfunction is extremely small. In the present invention, it goes without saying that a cam mechanism, a combined structure of a link mechanism and a cam mechanism, or any other mechanism can be used in place of the link mechanism 6.

The pressure reducing means 5 is operated by operating the operating means 8. The operating means 8 is provided with a fulcrum 84 with respect to the housing 21.
A lever 81 rotatably mounted around a lever, and a lever 8
1 and a spring 85 for urging the member 1 clockwise in FIG. An operation button 83 projecting out of the housing 21 is formed at the distal end of the lever 81, and a claw 82 that is engaged with the second engaging portion 54 is formed at the base end of the lever 81.

When the operation button 83 is not touched, the pawl 82 is inserted inside the opening 251 formed on the wall 25 (on the side approaching the depressurizing plunger 50) by the urging force of the spring 85. , Are locked or can be locked with the second locking portion 54. In the state shown in FIG. 6, when the operation button 83 is pressed with a finger or the like, the lever 81 rotates counterclockwise against the urging force of the spring 85 and the claw 8
2 is retracted from the opening 251, the engagement with the second engagement portion 54 is released, the plunger 50 for depressurization moves in the proximal direction, and the space 262 and the space 261 communicating therewith are brought into a decompressed state.

The operating means 8 operates the pressure reducing means 5 and also operates the puncturing means 3 in conjunction with the operation (almost simultaneously). That is, as shown in FIG. 7, the locking between the claw 82 and the second locking portion 54 is released,
When the pressure reducing plunger 50 moves in the proximal direction, the opening 2
The first locking portion 33 that has been locked to the space 41 and pressed into the space 262 is pressed against the base edge of the gasket 51 and
Pushed back to the first side, the engagement with the opening 241 is released. Thereby, the puncture plunger 30 moves toward the distal end, and the puncture needle 12 punctures the surface of the living body.

In the component measuring apparatus 1A, the direction in which the operation button 83 is pressed, that is, the direction in which the puncture plunger 30 is operated to perform puncture, is different from the direction in which the puncture plunger 30 moves (the puncture direction). (Directions substantially orthogonal to each other). Therefore, the fear of puncturing is reduced, and at the time of puncturing, the contact pressure of the tip of the projecting portion 91 of the tip 9 on the living body surface does not change due to the pressing force of the operation button 83, and thus the puncturing depth as set. Is realized.

The space 26 created by the operation of the pressure reducing means 5
The depressurized states 1 and 262 can be released by the decompression releasing means 7. The decompression releasing means 7 is provided with a lever 71 rotatably mounted on a fulcrum 74 with respect to the housing 21.
And a spring 75 for urging the lever 71 counterclockwise in FIG.
And a pulling wire 76.

An operation button 72 projecting out of the housing 21 is formed at a base end of the lever 71, and a hook 73 is formed at a tip of the lever 71. Traction wire 76
Is hooked on a hook 73, and the other end is fixed to an edge of the one-way valve 59.

When the operation button 72 is not touched by the hand, almost no tension acts on the pulling wire 76 due to the urging force of the spring 75, and the one-way valve 59 has the function described above. . As shown in FIG.
When the operation button 72 is pressed with a finger or the like in a depressurized state at 262, the lever 71 rotates clockwise against the urging force of the spring 75, and tension is applied to the pulling wire 76, and the one-way valve 5
The edge of 9 is pulled toward the tip and deformed. This allows
Outside air flows into the spaces 261 and 262 through the ventilation holes 58, and the spaces 261 and 262 return to the atmospheric pressure.

The seal rings 23, 52, 521 and the one-way valve 59 are each made of an elastic material. Examples of such an elastic body include natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber,
Various rubber materials such as nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, hydrin rubber, urethane rubber, silicone rubber, fluorine rubber, styrene, polyolefin, polyvinyl chloride, polyurethane, and polyester And various thermoplastic elastomers such as polyamide, polybutadiene and fluoro rubber.

The chip 9 is preferably made of a resin molded body, and has a projecting portion 91 projecting in an annular shape. The tip of the protruding portion 91 is a portion that comes into contact with the surface of a living body (sample collection site) such as a fingertip, an upper arm, an abdomen, a thigh, and an earlobe, and has a tip opening 92.

The outer peripheral edge of the distal end of the protruding portion 91 has a shape suitable for exerting an effect of stimulating the periphery of the puncture part when pressed against the surface of the living body (skin) and relieving pain at the time of puncture. Further, when the pressure is reduced by the pressure reducing means 5,
The shape is such that air can be suppressed as much as possible from flowing between the tip of the protruding portion 91 and the living body surface.

It is preferable that such a chip 9 is made of a transparent or colored transparent material in order to secure the visibility inside, and particularly to make it possible to visually check the bleeding state after puncturing.

A test paper 93 is provided on the back side of such a chip 9 and above the protruding portion 91 in FIG. The test paper 93 is obtained by supporting a reagent on a carrier capable of absorbing and developing a sample (blood).

Examples of the carrier include a sheet-like porous material such as a nonwoven fabric, a woven fabric, and a stretched sheet.
The porous body preferably has hydrophilicity.

The reagent carried on the carrier is appropriately determined depending on the component to be measured in the sample. For example, for blood glucose measurement, glucose oxidase (GOD), peroxidase (POD) and, for example, 4-aminoantipyrine, N-ethyl N- (2-hydroxy-3-sulfopropyl) -m-toluidine Coloring agent (coloring reagent)
Other examples include those that react with blood components such as ascorbate oxidase, alcohol oxidase, and cholesterol oxidase, and the same coloring agents (coloring reagents) as described above, depending on the components to be measured.
Further, a buffer such as a phosphate buffer may be further contained. Needless to say, the types and components of the reagents are not limited to these.

A printed circuit board (not shown) is provided in the main body 2.
Is mounted on the printed circuit board, and a control means 10 including a microcomputer is mounted on the printed circuit board, and controls various operations of the component measuring device 1A (see FIG. 11). The control unit 10 has a built-in arithmetic unit that calculates the amount of a component (for example, glucose) to be measured in a sample based on a signal from the photometric unit 13.

The measuring means 13 is for optically measuring the amount of a predetermined component (in the present embodiment, the amount of sugar in blood) in the specimen spread on the test paper 93. The photometric unit 13 is located on the back side of the chip mounting unit 22 and includes a light emitting element 131 and
And a light receiving element 42 (see FIG. 1).

The light emitting element 131 is electrically connected to the control means 10, and the light receiving element 132 is electrically connected to the control means 10 via an amplifier and the A / D converter 100 (not shown).

The light emitting element 131 operates according to a signal from the control means 10 and emits light. This light is preferably pulsed light that emits intermittently at predetermined time intervals. This pulse light has, for example, a period of 0.5 to 5.0 msec.
The light emission time of one pulse is about 0.05 to 0.3 msec. The wavelength of the pulse light is preferably 5
About 00 to 720 nm, more preferably 570 to 660 nm
Degree.

When the light emitting element 131 is turned on with the chip 9 mounted on the chip mounting section 22, the light emitting element 131 is turned on.
Is emitted to the test paper 93, and the reflected light is received by the light receiving element 132 and photoelectrically converted. An analog signal corresponding to the amount of received light is output from the light receiving element 132, and after being amplified as desired, the A / D converter 100
Is converted into a digital signal and input to the control means 10.

The control means 10 performs predetermined arithmetic processing on the basis of the input signal and, if necessary, carries out a correction calculation to determine the amount of the component to be measured in the sample (hereinafter referred to as "blood glucose level"). Do) find blood sugar level. The obtained blood sugar level is displayed on the display unit 14.

Further, the component measuring device 1 A
1, power supply voltage detection unit 102, switch circuit 103, control oscillation unit 105, clock oscillation unit 106, data storage unit 10.
7, a buzzer output unit 108, an external output unit 109, and a temperature measurement unit 110 (see FIG. 11).

The power supply unit 101 is loaded with a battery. The power supply voltage detection unit 102 detects the voltage of the battery and outputs the detected value to the control unit 10. Thereby, the remaining amount of the battery can be checked. The remaining battery level is displayed on the display unit 14.

The switch circuit 103 detects the inputs of the following various switches, and inputs the signals to the control means 10. As the types of switches, in addition to the power switch 104 described above, a storage data reading switch, a time setting /
There are a change switch, a reset switch, a buzzer operation / non-operation selection switch, a 50 Hz / 60 Hz commercial power frequency selection switch, and the like.

As described above, the power switch 104
It is turned on / off as the lid 27 opens and closes. The other switches can be operated by operating any one or a combination of two or more of a plurality of operation buttons (not shown).

The control oscillating unit 105 constitutes a timer, oscillates clock pulses at fixed time intervals, and supplies a reference signal for operation of the microcomputer (micro processing unit: MPU) of the control means 10.

The clock oscillating section 106 constitutes a clock for specifying an absolute time (date and time), oscillates clock pulses at fixed time intervals, and supplies a reference signal for operation of a clock control circuit incorporated in the control means 10. I do.

The data storage unit 107 has a first memory (R
AM), a second memory (ROM), and a third memory (non-volatile RAM). The photometric value (photometric data) input from the photometric means 13 is stored in the first memory according to a predetermined format.

Further, the relationship (calibration curve) between the absorbance obtained from the photometric value and the blood sugar level is stored in the second memory.

In the third memory, a calibration value unique to each device is stored in advance. The unique calibration values here include a prescribed value of the amount of reflected light, a correction coefficient for the final absorbance calculation, and the like.

The buzzer output section 108 activates the buzzer based on a signal from the control means 10 and emits a sound. The buzzer sounds, for example, when the measurement is completed.

The external output unit 109 is for outputting data such as the obtained blood sugar level to an external device such as a personal computer. In this case, the external output unit 109 has a built-in communication driver such as RS232C. When performing infrared communication, the external output unit 10
Reference numeral 9 includes an infrared light emitting element and a driving circuit for the infrared light emitting element.

The temperature measuring section 110 includes a temperature sensor (thermistor) that can measure the environmental temperature. The temperature measurement unit 110 measures the temperature at any time, and the temperature information is stored in the first memory of the data storage unit 13. Further, the temperature information read from the first memory is input to the control means 10 and is used for blood glucose level temperature correction calculation.

Next, the operation of each unit when performing puncturing, sample collection, deployment, and blood sugar level measurement using the component measuring apparatus 1A will be described with reference to FIGS. 2 to 10.

[1] When the lid 27 (the state shown in FIG. 2) in the closed state is rotated clockwise and gradually opened,
The shaft 29 rotates in the same direction, and by the action of the link mechanism 6,
The piston 65 moves toward the distal end (see FIG. 3). As a result, the locking member 53 is pressed by the piston 65, and the pressure reducing plunger 50 moves in the distal direction. By this movement, the coil spring 56 is gradually compressed.

As the depressurizing plunger 50 moves in the distal direction, the air in the space 262 surrounded by the walls 24 and 25, the gasket 51, and the shielding member 57 passes through the openings 241, 261 and 221. After the gasket 51 passes through the opening 241, the gasket 51 is discharged through the vent hole 58. [2] When the gasket 51 comes into contact with or comes closest to the shielding member 57, the second locking portion 54 of the locking member 53
And is located on the tip side of the claw 82 (see FIG. 4). At this time, the first link 61 and the second link 62 form a straight line.

[3] When the clockwise rotation of the lid 27 further proceeds from the state shown in FIG. 4, the piston 65 starts to return in the proximal direction. The compressed coil spring 56
Of the pressure reducing plunger 50 also tends to move in the proximal direction by the elastic force of
It stops at that position (see FIG. 5). At this time, the gasket 51 is located on the tip side from the opening 241. In this state, the preparation for the operation of the pressure reducing means 5 is completed.

[4] When the operation of opening the lid 27 is almost completed, the end of the first link 61 contacts the trigger of the power switch 104, and the power switch 104 is turned on (FIG. 5).
reference). Thereby, each part of the component measuring device 1A is activated and becomes in a measurable state.

In this state, the display section 14 can be viewed almost entirely without being covered by the lid 27.

[5] Next, the lancet 11 having the puncture needle 12 is mounted on the needle holder 31. First, the lancet 11 is inserted into the main body 2 through the opening 221 of the tip mounting portion 22 by using a predetermined tool or the like, and the base end of the lancet 11 is fitted to the needle holder 31 (see FIG. 6).

When the lancet 11 is further pushed in the proximal direction, the puncture plunger 30 moves in the proximal direction against the urging force of the coil spring 35. The first locking portion 33
It is urged by the elastic force of the elastic piece 32 and is in contact with the wall portion 24. However, when the first locking portion 33 comes to the position of the opening 241, it is inserted into the opening 241 and protrudes toward the space 262 ( See FIG. 6). Thereby, even if the pressing force in the proximal direction by the lancet 11 is released, the first locking portion 33 is
1 and the movement of the puncture plunger 30 in the distal direction is restricted. At this time, the coil spring 35 is in a compressed state. In this state, preparation for puncturing by puncturing means 3 is completed.

By adjusting the direction of rotation and the amount of rotation of the movable member 47 with respect to the fixed member 41, the maximum projection length of the puncture needle 12 from the opening 221, that is, the puncture depth of the puncture needle 12 into the specimen collection site is determined in advance. Is set.

[6] Next, the chip 9 is mounted on the chip mounting section 22 (see FIG. 6). This allows blood (specimen)
Preparation for collection is complete.

[7] Projecting portion 91 of mounted chip 9
To the fingertip (sample collection site) 15. At this time, the tip opening 92 of the protruding portion 91 is closed with the fingertip 15 so as to minimize air leakage (see FIG. 7).

[8] The operation button 83 is pressed. As a result, the lever 81 rotates counterclockwise against the urging force of the spring 85, the claw 82 comes off the second locking portion 54, and the pressure reducing plunger 50 moves in the proximal direction by the elastic force of the coil spring 56. Start moving (see FIG. 7). The space 262 and the space 261 communicating therewith are provided with the seal rings 52, 521, 2
3 and the fingertip 15, and the inflow of air from the vent hole 58 is prevented by the action of the one-way valve 59, so that the pressure-reducing plunger 50 moves in the proximal direction. Accordingly, the pressure in the spaces 262 and 261 is reduced, and the spaces 262 and 261 are in a reduced pressure state.

The minimum pressure in the space 261 caused by the operation of the pressure reducing plunger 50 is preferably lower than the atmospheric pressure by, for example, about 300 mmHg. Thereby, a required amount of blood can be bleeding in a short time.

Immediately after the movement of the pressure reducing plunger 50 in the proximal direction (pressure reducing operation by the pressure reducing means 5) is started,
When the gasket 51 passes through the opening 241, the base edge of the gasket 51 comes into contact with the first locking portion 33 locked in the opening 241 and pushes it back to the space 261 (FIG. 7).
reference). As a result, the locking of the first locking portion 33 is released, the puncture plunger 30 moves in the distal direction by the elastic force of the compressed coil spring 35, and the puncture needle 12 passes through the inside of the tip 9 and the projecting portion. The fingertip 15 protrudes from the distal end opening 92 and punctures the surface of the fingertip 15 (see FIG. 8). Puncture needle 1
Bleeding occurs from the puncture site due to 2.

At this time, since the movement of the puncture plunger 30 in the distal direction is restricted by the engagement of the locking portion 46 with the stopper 49, the puncture depth of the fingertip 15 by the puncture needle 12 is kept constant. It is.

[9] After the puncture needle 12 punctures the fingertip 15, the coil spring 35 returns to its natural length through a damping motion,
The puncture needle 12 comes out of the surface of the fingertip 15 and is stored in the housing 21 inside the tip opening 92 and the opening 221 of the tip (see FIG. 9). Thus, the puncture needle 12
Except at the time of puncturing, it does not protrude from the tip opening 92 and the opening 221, so that the skin and the like are not accidentally damaged, infection can be prevented, and safety is high.

[10] As described above, the space 261
Is in a decompressed state, so that the tip opening 9 of the tip 9 is
The puncture site of the fingertip 15 located inside the puncture needle 2 by the puncture needle 12 is also in a decompressed state.
Is sucked out. That is, bleeding is promoted as compared with a case where such suction is not performed, and a required amount of blood can be secured in a short time.

As described above, in the component measuring device 1A, 1
Since the depressurizing operation and the puncturing operation are performed almost simultaneously by pressing the operation button 83 twice, the operability is extremely good.

[11] After puncturing the fingertip 15 with the puncture needle 12 and confirming an appropriate amount of bleeding through the tip 9, the operation button is pressed while the tip of the protrusion 91 of the tip 9 is in contact with the fingertip 15. Press 72. Thereby, the spring 75
The lever 71 rotates clockwise against the urging force of the one-way valve 59, the edge of the one-way valve 59 is pulled toward the distal end via the pulling wire 76 and deformed, and the outside air flows through the air hole 58 into the space 26.
1, 262 and return to the atmospheric pressure in the spaces 261 and 262 (see FIG. 10).

At this time, since the inflow portion of the outside air is far away from the blood 16 on the puncture site, and the inflow of the outside air is not rapid, the blood 16 on the puncture site may not be scattered by the air flow. Absent.

When it is confirmed that the sense of suction around the puncture site of the fingertip 15 has disappeared and the pressure has returned to the atmospheric pressure, the protruding portion 91 of the chip 9 is separated from the fingertip 15.

[12] Further, before and after the release of the reduced pressure state of the above [11], the blood 1 protruding granularly on the puncture site is obtained.
6 is transferred to the test paper 93 via a groove (not shown) formed inside the chip 9, for example, and is spread on the test paper 93.

The test paper 93 is colored according to the amount of sugar (component to be measured) contained in the blood 16 by the action of the reagent carried. The degree of coloration is measured by the measuring means 132 described above, and based on the obtained data, the control means 1
Calculation processing is performed at 0, and correction such as temperature correction calculation and hematocrit value correction calculation is performed to quantify the blood sugar level. And
The result is displayed on the display unit 14.

FIG. 12 is a perspective view showing another embodiment of the component measuring apparatus of the present invention. Component measuring device 1B shown in FIG.
Is a box-shaped main body 200 and a hinge 20
And a lid 201 rotatably supported through the cover 2.

A circular recess 206 is formed in the center of the upper surface of the main body 200, and the chip mounting portion 20 is formed in the recess 206.
3 are formed. The chip 300 having the protruding portion 301 is detachably mounted on the chip mounting portion 203.

The main body 200 includes a plurality of chips 30.
A chip housing portion 204 is formed, which is formed by a concave portion capable of housing 0. A small window 2 on the side of the chip storage unit 204 through which the number of chips 300 stored in the chip storage unit 204 can be visually recognized with the lid 201 closed.
05 is formed.

Although not shown in FIG. 12, the main body 200 has a puncturing means 3, an adjusting mechanism 4, a depressurizing means 5, and a link mechanism 6 (or similar to those described in the component measuring apparatus 1A). A mechanism that performs the same function as above), a decompression releasing unit 7, an operating unit 8, a control unit 10, a measuring unit 13, and the like are provided.

The operation button 83 of the operation means 8 and the operation button 72 of the decompression releasing means 7 respectively protrude into a recess 207 formed on the upper surface of the main body 200.

A liquid crystal display element (L
A display unit 208, such as a CD), is provided.

In the component measuring device 1B, when the lid 201 is closed, the chip mounting section 203 is covered with the lid 201 and the display section 208 is also covered. When the lid 201 is opened, the operation of the decompression means 5 is prepared in the same manner as described above.

When the operation button 83 of the operation means 8 is pressed, the operation of the pressure reducing means 5 and the operation of the puncturing means 3 are performed in an interlocked manner (almost simultaneously or in a predetermined order).

Although the component measuring apparatus of the present invention has been described based on the embodiments shown in the drawings, the present invention is not limited to these embodiments. Any configuration obtained can be substituted.

Further, in the above embodiments, blood was described as a sample, but the sample is not limited to this, and other samples such as interstitial fluid such as urine, lymph, cerebrospinal fluid, saliva, and body fluid may also be used. Good.

The component to be measured is not limited to glucose (blood sugar level), but may be, for example, inorganic ions such as protein, cholesterol, uric acid, creatinine, alcohol, and sodium, and hemoglobin (occult blood).

Further, the component measuring device of the present invention optically measures (colorimetrically measures) the color intensity of the test paper colored by the reaction between the components in the sample and the reagent as described above, and converts the measured value into a measured value. In addition to the conversion and display, a change in potential generated according to the amount of the component in the sample may be electrically measured, converted to a measured value, and displayed.

[0128]

As described above, according to the present invention, puncture, collection of body fluid (blood, etc.), development on a test paper, and measurement (quantification of components) can be performed continuously. Measurement can be performed easily and in a short time. In this case, the operability is excellent, and the operation of opening the lid is particularly convenient because the preparation of the operation of the pressure reducing means and the turning on of the power switch are performed.

Further, since the preparation operation at the time of use is easy, it is advantageous when the device is used regularly or repeatedly.

In addition, since the suction around the puncture site can be performed by the decompression means, the outflow (bleeding) of bodily fluids is promoted, and the amount of bodily fluid necessary for an examination or the like can be promptly removed even with shallow puncture with little pain. Can be secured.

Further, when the decompression releasing means is provided, scattering (contamination) of bodily fluid due to a rapid flow of air near the puncture site can be prevented, which is sanitary.

Further, accidents such as accidental puncturing of the living body surface after puncturing once are prevented, and the safety is high. Moreover, since the puncture needle is not directly visible, fear of puncturing is reduced.

Further, since the puncture depth by the puncture needle is appropriate, a required amount of body fluid can be secured with minimum pain. In particular, when a mechanism for adjusting the puncture depth is provided, the puncture depth can be appropriately adjusted according to various conditions such as individual differences and the puncture site, and each time a bodily fluid is collected (blood collection), A constant puncture depth can be achieved.

When the puncture direction of the puncture needle and the operation direction of the puncture operation are made different,
The force of the operation does not act on the surface of the living body to be punctured, so that more stable puncturing can be performed, the puncturing depth as set is realized, and the fear of puncturing is reduced.

As described above, the component measuring apparatus of the present invention is suitable for use when a patient himself / herself measures a blood sugar level or the like.

The component measuring apparatus of the present invention has a simple structure, is inexpensive, and is suitable for mass production.

[Brief description of the drawings]

FIG. 1 is a perspective view showing an embodiment of a component measuring device of the present invention.

FIG. 2 is a sectional plan view showing an internal structure and an operation state of the component measuring device of the present invention shown in FIG.

FIG. 3 is a cross-sectional plan view showing an internal structure and an operation state of the component measuring device of the present invention shown in FIG.

FIG. 4 is a cross-sectional plan view showing an internal structure and an operation state of the component measuring device of the present invention shown in FIG.

5 is a cross-sectional plan view showing the internal structure and operating state of the component measuring device of the present invention shown in FIG.

6 is a cross-sectional plan view showing the internal structure and operating state of the component measuring device of the present invention shown in FIG.

FIG. 7 is a cross-sectional plan view showing an internal structure and an operating state of the component measuring device of the present invention shown in FIG.

8 is a cross-sectional plan view showing the internal structure and operating state of the component measuring device of the present invention shown in FIG.

9 is a cross-sectional plan view showing an internal structure and an operation state of the component measuring device of the present invention shown in FIG.

10 is a cross-sectional plan view showing an internal structure and an operation state of the component measuring device of the present invention shown in FIG.

11 is a block diagram showing a circuit configuration of the component measuring device of the present invention shown in FIG.

FIG. 12 is a perspective view showing another embodiment of the component measuring device of the present invention.

[Explanation of symbols]

 1A, 1B Component measuring device 2 Main body 21 Housing 22 Tip mounting part 221 Opening 23 Seal ring 24 Wall part 241 Opening 25 Wall part 251 Opening 261 Space 262 Space 27 Lid 28 Shielding part 29 Axis 3 Lancing means 30 Puncture plunger 31 Needle Holder 32 Elastic piece 33 First locking part 34 Projecting part 35 Coil spring 4 Adjusting mechanism 41 Fixed member 42 Guide groove 43 Spacer 44 Projection 45 Shaft 46 Locking part 47 Movable member 48 Depression 49 Stopper 5 Decompression means 50 Decompression plunger 51 Gasket 52 Seal ring 521 Seal ring 53 Locking member 54 Second locking portion 55 Flange 56 Coil spring 57 Shielding member 58 Vent hole 59 One-way valve 6 Link mechanism 61 First link 62 Second link 63 Pin 64 Pin 65 Piston 7 Decompression Removal means 71 Lever 72 Operation button 73 Hook 74 Support point 75 Spring 76 Pulling wire 8 Operation means 81 Lever 82 Claw 83 Operation button 84 Support point 85 Spring 9 Chip 91 Projection 92 Tip opening 93 Test paper 10 Control means 100 A / D converter Reference Signs List 101 power supply section 102 power supply voltage detection section 103 switch circuit 104 power switch 105 control oscillation section 106 clock oscillation section 107 data storage section 108 buzzer output section 109 external output section 110 temperature measurement section 11 lancet 12 puncture needle 13 measuring means 131 light emitting element 132 Light receiving element 14 Display part 15 Fingertip 16 Blood 200 Main body 201 Lid 202 Hinge 203 Chip mounting part 204 Chip storage part 205 Small window 206 Depression 207 Depression 208 Display part 300 Chip 301 Projection

 ────────────────────────────────────────────────── ─── Continuing on the front page (72) Inventor Tomo Ijiri 2-44-1, Hatagaya, Shibuya-ku, Tokyo Terumo Corporation F-term (reference) 2G045 AA13 CA25 CB30 DA31 FA11 FB16 FB17 GC12 HA07 HA10 HA13 HA14 JA07 4C038 KK10 KL01 KL07 KX04 KY01 KY03 TA02 UA01 UE02 UE04 UE05 UE07 UE10 UF03 UF06 UF07 UF10

Claims (17)

[Claims] 1. A component measuring device for measuring an amount of a predetermined component in a specimen using a test paper, comprising: a main body having a chip mounting portion for mounting a chip including the test paper; A lid body that is freely installed and covers the tip mounting portion when in a closed state, a puncture needle can be mounted, and a puncturing means that punctures a specimen collection site with the mounted puncture needle; A pressure reducing unit that can put a puncture site in a reduced pressure state; and a measuring unit that measures an amount of a predetermined component in a sample spread on a test paper. A component measuring device, characterized in that it is configured to prepare for operation of the component. 2. The component measuring device according to claim 1, further comprising a display unit for displaying a measurement result, wherein the component measurement unit covers the display unit when the lid is closed. 3. The component measuring device according to claim 1, wherein the operation of the pressure reducing unit and the operation of the puncturing unit are performed in an interlocked manner. 4. The component measuring apparatus according to claim 1, further comprising operating means for causing said depressurizing means and said puncturing means to operate substantially simultaneously or in a predetermined order. 5. The component measuring device according to claim 1, wherein said puncturing means includes an adjusting mechanism for adjusting a puncturing depth. 6. The puncturing means comprises: a puncturing plunger;
The component measuring device according to claim 1, further comprising a first biasing unit configured to bias the puncture plunger. 7. The puncturing plunger has a first locking portion that regulates movement in the distal direction, and engages the first locking portion in a state where it is urged by the first urging means. 7. The component measuring device according to claim 6, wherein the component is moved in the distal direction by releasing the stop and puncture is performed with a puncture needle. 8. The component measuring device according to claim 6, wherein a direction of an operation for performing puncturing by operating the puncturing plunger is different from a moving direction of the puncturing plunger. 9. The pressure reducing device according to claim 1, further comprising: a pressure reducing plunger provided with an airtight sealing member; and a second biasing means for biasing the pressure reducing plunger. The component measuring device as described in the above. 10. The pressure-reducing plunger has a second locking portion for restricting movement in the proximal direction, and the second locking portion is biased by the second biasing means. The component measuring device according to claim 9, wherein the component is moved in a proximal direction by releasing the locking, and the reduced pressure state is generated. 11. The pressure reducing means includes a pressure reducing plunger provided with an airtight sealing member, and a second biasing means for biasing the pressure reducing plunger. It has a second locking portion that regulates movement in the proximal direction, and moves in the proximal direction by releasing the locking of the second locking portion while being urged by the second urging means. The component measuring device according to claim 7, wherein the depressurized state is caused, and the locking of the first locking portion is released. 12. The component measuring device according to claim 1, wherein said pressure reducing means has a one-way valve. 13. The component measuring device according to claim 1, further comprising a transmission mechanism that is connected to a rotation shaft of said lid and transmits a rotation force of said rotation shaft to said pressure reducing means. 14. The component measuring apparatus according to claim 1, further comprising a decompression releasing means for releasing the decompressed state by said decompression means. 15. A puncture needle attached to the puncture means,
The component measuring device according to any one of claims 1 to 14, wherein the specimen is punctured at the sample collection site after passing through the chip mounting portion. 16. The component measuring device according to claim 1, wherein the chip mounting portion has a sealing member for maintaining airtightness with the mounted chip. 17. The component measuring device according to claim 1, further comprising a power switch, wherein the power switch is turned on when the lid is opened.