JP2002058661A - Component measuring apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a component measuring apparatus which can surely measure prescribed components in body fluid in a short time. SOLUTION: This component measuring apparatus 1 mainly equipped with a main body 2, a finger touching part 3, a puncture means 4 housed in a housing 5, a tip withdrawing mechanism 6, a pump 8, an electromagnetic valve, a pressure sensor, and a measuring means 7. A tip 13 is mounted on the housing 5 and a fingertip is pressed onto the finger touching part 3 to seal up the tip end of the tip 13. When an operation button 222 is pressed down, the pump 8 is actuated and the pressure in the housing 5 is detected by the pressure sensor. Only when the inside of the housing 5 is in a decompression condition, a puncture needle equipped on the tip 13 punctures the fingertip. Blood is sucked out from the puncture site. When the blood collection is detected, the pump 8 is stopped and the electromagnetic valve is opened to release the decompressing condition. After that, prescribed components are measured by the measuring means 7, processed by a control means 11, and then the result is displayed on a display part 12.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a component measuring device, and more particularly, to a blood test, in which a fingertip is punctured with a puncture needle to collect blood and to determine the amount of a specific component such as glucose in the blood. The present invention relates to a component measuring device for measuring.

[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, a patient may take his or her own blood by puncturing the skin of the fingertip with a puncture device equipped with a puncture needle or a scalpel, and pressing around the puncture site with a finger or the like. The blood is 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.

In a conventional blood glucose measurement, a puncture operation and
Since the blood sampling operation and the measurement operation are performed separately, the operability is also poor.

As a device capable of solving such a problem, there is known a blood glucose measuring device in which a puncturing device and a measuring device are integrated and provided with a suction means for squeezing blood (Japanese Patent Application No. Hei 10 (1999)). 183794, Japanese Patent Application No. 10-33
0057).

In these blood glucose measuring devices, first, a fingertip is pressed against the tip of the chip, and the opening of the tip is sealed so as to maintain airtightness.

Next, after puncturing the fingertip with a puncture needle protruding from the distal end opening, the suction means is operated (in a reduced pressure state) in this state, blood is drawn from the punctured site, and the blood is collected. Then, the blood glucose level of the collected blood is measured by the measuring device.

However, in the blood glucose measuring device, depending on the position of the pressed finger or the like, a gap is formed between the finger and the tip of the tip, and the pressure cannot be sufficiently reduced even when the suction means is operated. As a result, the blood volume required for measuring the blood sugar level cannot be obtained, or it takes a relatively long time to obtain a sufficient blood volume.

[0011]

SUMMARY OF THE INVENTION An object of the present invention is to provide a component measuring device capable of reliably measuring a predetermined component in a body fluid in a short time.

[0012]

This and other objects are achieved by the present invention which is defined below as (1) to (16).

(1) A component measuring apparatus for collecting a body fluid through an epidermis and measuring a component of the body fluid, wherein the applying section applies the epidermis and the applying section applies the epidermis to the airtight section. A closed space, a decompression means for decompressing the space, a measurement means for measuring an amount and / or a property of a predetermined component in a bodily fluid collected in the space, and a pressure for detecting a pressure in the space Detecting means, notifying means for notifying predetermined information, trying to depressurize the space by the pressure reducing means, based on the information from the pressure detecting means, to be notified by the notifying means, A component measuring device, comprising:

(2) A component measuring device which is used by mounting a tip provided with a puncture needle, wherein the puncture portion is applied to an epidermis to be punctured, and the puncture is performed to puncture the epidermis applied to the puncture portion. A puncturing means for operating a needle, a storage space for the puncture needle, a decompression means for reducing the pressure of the puncture site of the epidermis by the puncture needle, a pressure detection means for detecting a pressure in the storage space, and a puncture site. Measuring means for measuring the amount of a predetermined component in the collected blood, and a notifying means for notifying predetermined information, tried to decompress the storage space by the decompression means, to the information from the pressure detection means A component measuring device configured to perform notification by the notification unit based on the information.

(3) A component measuring device which is used by mounting a tip provided with a puncture needle, wherein the puncture portion is applied to an epidermis to be punctured, and the puncture is performed so as to puncture the epidermis applied to the abutment portion. A puncturing means for operating a needle, a storage space for the puncture needle, a decompression means for reducing the pressure of the puncture site of the epidermis by the puncture needle, a pressure detection means for detecting a pressure in the storage space, and a puncture site. Measuring means for measuring the amount of the predetermined component in the collected blood; and notifying means for notifying predetermined information, the pressure reducing means attempts to decompress the storage space, and the pressure detecting means detects the storage space. A component measuring device characterized in that when the depressurized state is not detected, the notifying unit notifies an error.

(4) A component measuring device to be used with a tip provided with a puncture needle, wherein the puncture portion is applied to the epidermis to be punctured, and the puncture is performed to puncture the epidermis applied to the puncture portion. A puncturing means for operating a needle, a storage space for the puncture needle, a decompression means for reducing the pressure of the puncture site of the epidermis by the puncture needle, a pressure detection means for detecting a pressure in the storage space, and a puncture site. Measuring means for measuring the amount of the predetermined component in the collected blood; and notifying means for notifying predetermined information, the pressure reducing means attempts to decompress the storage space, and the pressure detecting means detects the storage space. When the depressurized state is not detected, the notifying means notifies that the position of the epidermis applied to the contact portion should be corrected, and also notifies the pressure detecting means even after a lapse of a predetermined time. A component measuring device characterized in that when the depressurized state of the storage space is not detected, an error is notified by the notification means.

(5) Any of the above (2) to (4), wherein the puncture needle is operated by the puncture means when the depressurized state of the storage space is detected by the pressure detection means. The component measuring device according to any one of the above.

(6) A component measuring device to be used by mounting a tip provided with a puncture needle, wherein the puncture portion is applied to the epidermis to be punctured, and the puncture is performed so as to puncture the epidermis applied to the abutment portion. A puncturing means for operating a needle, a storage space for the puncture needle, a decompression means for reducing the pressure of the puncture site of the epidermis by the puncture needle, a pressure detection means for detecting a pressure in the storage space, and a puncture site. Measuring means for measuring the amount of a predetermined component in the collected blood, the pressure reducing means attempts to decompress the storage space, and if the pressure detecting means detects the depressurized state of the storage space, A component measuring device configured to operate the puncture needle by the puncture means.

(7) A drive source electrically driven is provided,
Operating means for starting the operation of the puncturing means by driving the drive source, wherein when the pressure detecting means detects a reduced pressure state in the storage space, the operation starting means operates the puncturing means. Is started, and the puncture needle is operated by the puncture means. (5) or (6).

(8) The puncturing means includes a plunger,
The component measuring device according to any one of (2) to (6), further including an urging member for urging the plunger in a distal direction.

(9) The plunger has a locking portion for restricting the movement of the plunger in the distal direction, and releases the locking of the locking portion in a state where the plunger is urged by the urging member. The component measuring device according to the above (8), which moves in a direction and performs puncturing with the puncture needle.

(10) There is provided a drive source which is electrically driven, and there is provided an operation start means for releasing the locking of the locking portion by driving the drive source, and the pressure detecting means reduces the pressure in the storage space. The component measuring device according to (9), wherein when the is detected, the locking of the locking portion is released by the operation start means.

(11) When the depressurized state of the storage space is detected by the pressure detecting means, the depressurized state is temporarily released, and thereafter the puncture is performed, and the puncture needle is detected by the depressurizing means. The component measuring device according to any one of the above (2) to (10), wherein the puncture site of the finger with the puncture needle is set in a reduced pressure state together with the storage space.

(12) The component measuring device has a housing that holds the chip and houses the puncturing means, and the decompression means puts the storage space in the housing into a decompressed state. The component measuring device according to any one of (1) to (11).

(13) The pressure detecting means detects the pressure of the storage space in the housing (12).
The component measuring device according to 1.

(14) The above-mentioned chips (2) to (13), wherein the chip has a contact portion for contacting the skin, and the opening formed inside the contact portion is closed by the skin.
The component measuring device according to any one of the above.

(15) The component measuring apparatus according to any one of (2) to (14), wherein the chip has a test paper and a blood passage for supplying blood to the test paper.

(16) The component measuring apparatus according to (15), wherein the test paper is a test paper for measuring blood glucose.

[0029]

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

The component measuring apparatus according to the present invention is an apparatus for collecting a body fluid (hereinafter, blood is representatively described in the present embodiment) through an epidermis (skin) and measuring a predetermined component of the body fluid. .

The part of the epidermis involved in the collection of the body fluid (in this embodiment, the puncture part) is preferably a finger, but may be, for example, a palm, a back of a hand, a side part of a hand, an arm,
Thighs and the like.

In the following embodiment, a component measuring device in which a fingertip (finger) is punctured will be described as a representative.

FIG. 1 is a perspective view schematically showing a first embodiment of a component measuring apparatus according to the present invention, FIG. 2 is a longitudinal sectional view showing an example of the configuration of a chip used in the present invention, FIG. 3 and FIG.
Is a longitudinal sectional view showing a configuration example of a puncturing means and a housing containing a puncturing means of the component measuring device of the first embodiment, respectively. FIGS. FIG. 12 is a longitudinal sectional view showing a configuration example of a main part, FIG. 12 is a block diagram showing a circuit configuration of the component measuring device of the first embodiment, and FIG. 13 shows a control operation of a control unit of the component measuring device of the first embodiment. It is a flowchart shown. 1 to 11, the right side is referred to as a “proximal end” and the left side is referred to as a “distal end”.

As shown in FIGS. 1, 5 and 12, a component measuring device (blood component measuring device) 1 of the first embodiment
The main body 2, the finger pad 3 installed on the main body 2, the puncturing means 4 stored in the housing 5, the tip retreat mechanism 6 provided on the base end side of the housing 5, and the collection of blood (body fluid) Measuring means 7 for detecting a predetermined component in the collected blood (body fluid) while detecting the pressure, a pump 8 for reducing the pressure inside the housing 5, and an electromagnetic valve for releasing, relaxing or holding the reduced pressure inside the housing 5 26, a pressure sensor (pressure detecting means) 27 for detecting the pressure in the housing 5,
Solenoid (drive source) 28, switch 29, battery (power supply) 9, and control means 1 provided on circuit board 10
1 and a memory 33, a display unit (notification unit) 12, a voice output unit (notification unit) 32, and an external output unit 34.

The component measuring device 1 is used with a chip 13 mounted thereon. Hereinafter, each component will be described.

The main body 2 is composed of a housing 21 and a lid 22 facing each other. The main body 2 has a storage space 23 formed therein. In the storage space 23, the puncturing means 4, the housing 5, the tip retracting mechanism 6, the measuring means 7, the pump 8, the solenoid valve 26, the solenoid 28, switch 29, battery 9, circuit board 10, control means 11, memory 33, display unit 12, audio output unit 32, and external output unit 3
4 are stored respectively. Further, a pressure sensor 27 is provided in the housing 5.

An opening 21 which penetrates the inside and outside of the housing 21 and has a circular cross section
2 are formed. The chip 13 is mounted (held) on the housing 5 described later via the opening 212.

On the surface on the tip end side of the wall portion 211, a finger contact portion (a contact portion to which the skin is applied) 3 is formed so as to surround the outer periphery of the opening 212 and correspond to the shape of the fingertip (finger). Is installed. A finger contact surface 31 is provided on the distal end side of the finger contact portion 3.
Are formed. The component measuring device 1 is operated while the fingertip is in contact with the finger contact portion 3 (finger contact surface 31). Thereby, the fingertip is punctured, and the amount of a predetermined component (hereinafter, glucose is described as a representative in the present embodiment) in the collected blood is measured.

On the upper surface of the lid 22, a display window (opening) 221 penetrating the inside and outside of the lid 22 is formed, and the display window 221 is closed by a plate-like member made of a transparent material. Have been.

The storage space 23 corresponding to the display window 221
The display unit 12 is installed at a position inside the inside. Therefore, various information displayed on the display unit 12 can be confirmed via the display window 221.

The display section 12 is, for example, a liquid crystal display element (L
CD) and the like. The display unit 12 can display, for example, power on / off, power supply voltage (remaining battery level), measured value, measurement date and time, error display, position correction display, operation guidance, and the like.

The audio output unit 32 is composed of, for example, a buzzer (a device that emits a fixed sound or a melody), a device that emits words, and the like.

The notifying means is not limited to the above-mentioned means.
In addition, for example, a light emitting element such as a light emitting diode (LED) and an EL element, a lamp, an EL display element, and the like can be given.

The external output section 34 is for outputting data such as the obtained blood sugar level to an external device such as a personal computer.

An operation button 2 is provided on the upper surface of the lid 22.
22 are installed. The component measuring device 1 is configured such that when the operation button 222 is pressed, the switch 29 is turned on in conjunction with the operation button 222 and the signal is input from the switch 29 to the control unit 11.

On the lower side of the display section 12 in FIG.
The control means 11 including a microcomputer and a memory 33 are mounted on the circuit board 10. The control unit 11 controls various operations of the component measuring device 1, such as determining whether or not blood has been collected, determining whether or not the blood pressure has been reduced, and the like. The control means 11
Has a built-in calculation unit that calculates the amount of glucose in blood (blood sugar level) based on a signal from the measuring means 7.

On the lower left side of the circuit board 10 in FIG. 1, a pump 8 is provided as a decompression means (suction means). The pump 8 is operated by electric power, and is connected to a ventilation path 54 formed in the housing 5 described later via a tube 81. This tube 81 has flexibility, for example, polyvinyl chloride, polyethylene,
Polypropylene, ethylene-vinyl acetate copolymer (EV
A) such as polyolefins, polyamides, polyesters,
It is made of a polymer material such as silicone rubber and polyurethane.

The pump 8 is provided in the cavity 5 of the housing 5.
By sucking and discharging the air in the housing 2, the housing 5
The inner cavity 52 is set in a reduced pressure state. In particular, the component measuring apparatus 1 attempts to depressurize the lumen 52 of the housing 5 by the pump 8 before, simultaneously with, or after puncturing of the tip 13 with the needle 141 described later. ing.

The pump 8 is capable of sucking blood from the puncture site of the fingertip (for example, 100 to 40).
(About 0 mmHg) as long as the pressure can be applied to the inner cavity 52 of the housing 5 and the puncture site at the fingertip.

On the lower right side of the circuit board 10 in FIG. 1, a battery 9 is installed as a power source. The battery 9 is electrically connected to the pump 8, the solenoid valve 26, the solenoid 28, the control unit 11, the display unit 12, the audio output unit 32, and the like, and supplies electric power necessary for the operation thereof.

The measuring means 7 is provided on the near side of the pump 8 in FIG.
Is installed. The measuring means 7 includes a chip 1 described later.
3 optically detects the supply (collection) of blood to the test paper 18 provided in the test paper 3 and optically measures the amount of glucose in the blood spread on the test paper 18. In a state where the chip 13 is mounted and held in the housing 5, the tip 13 is located near the side where the test paper 18 is located.

As described above, the measuring means 7 has both the function of detecting the collection of blood and the function of measuring the amount of glucose (predetermined component) in the blood spread on the test paper 18. The number of parts can be reduced, the configuration can be simplified, and the number of assembling steps of the apparatus can be reduced as compared with the case where the means are separately provided.

The measuring means 7 has a light emitting element (light emitting diode) 71 and a light receiving element (photodiode) 72.

The light emitting element 71 is electrically connected to the control means 11, and the light receiving element 72 is electrically connected to the control means 11 via the amplifier 24 and the A / D converter 25.

The light emitting element 71 is activated by a signal from the control means 11 and emits light. This light is preferably pulsed light that emits intermittently at predetermined time intervals.

When the light emitting element 71 is turned on with the chip 13 mounted on the housing 5, the light emitted from the light emitting element 71 is irradiated on the test paper 18, and the reflected light is received by the light receiving element 72. Photoelectric conversion is performed. Light receiving element 72
Outputs an analog signal corresponding to the amount of received light, and after the signal is amplified as desired by the amplifier 24,
The signal is converted into a digital signal by the / D converter 25 and input to the control means 11.

The control means 11 determines whether or not blood has been collected, that is, whether or not blood has been spread on the test paper 18 of the chip 13 based on the input signal.

Further, the control means 11 performs predetermined arithmetic processing on the basis of the input signal and, if necessary, performs correction calculation to obtain the amount of glucose in blood (blood glucose level). The obtained blood sugar level is displayed on the display unit 12.

A housing 5 containing the puncturing means 4 and a tip retracting mechanism 6 connected to the base end of the housing 5 are provided on the near side of the measuring means 7 in FIG.

The chip retracting mechanism 6 is fixed to the housing 21, while the housing 5 is not fixed to the housing 21, but is moved by the chip retracting mechanism 6 in the axial direction (the left and right direction in FIG. 1). It is installed so that it can be moved.

As described above, this component measuring device 1
The chip 13 is mounted on the housing 5 for use. As shown in FIG. 2, the tip 13 includes a puncture needle 14, a first housing 15 for slidably storing the puncture needle 14,
A second housing 16 installed on an outer peripheral portion of the first housing 15, a test paper fixing portion 17 installed on an outer peripheral portion of the second housing 16, and a test paper 18 fixed on the test paper fixing portion 17. It is composed of

The puncture needle 14 includes a needle 141 and a needle 141.
And a hub 142 fixed to the base end side of the first housing 15 and housed in the inner cavity 152 of the first housing 15.

The needle body 141 is formed of a hollow member or a solid member made of a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy, and has a sharp cutting edge (needle tip) at its tip. Are formed. With this cutting edge, the surface (skin) of the fingertip is punctured.

The hub 142 is formed of a substantially columnar member, and its outer peripheral portion slides while being in contact with the inner peripheral surface 151 of the first housing 15.

A reduced diameter portion 143 is formed at the base end of the hub 142. The reduced diameter portion 143 is used for the needle holder 4 of the plunger 41 constituting the puncturing means 4 described later.
11 is fitted.

The first housing 15 is formed of a bottomed cylindrical member having a wall 153 as a bottom, and has a lumen 152 formed therein.

At a substantially central portion of the wall 153, a hole 154 having a circular cross section is formed. This hole 154
The needle 141 passes through when the fingertip (finger) is punctured. The hole diameter of the hole 154 is set smaller than the outer diameter of the tip of the hub 142. For this reason, when the puncture needle 14 moves toward the distal end of the inner cavity 152 and the distal end of the hub 142 abuts against the proximal end of the wall 153, the puncture needle 14 is prevented from further moving in the distal direction. Is done. Therefore, the length of protrusion of the needle body 141 from the tip of the tip 13 is kept constant when the fingertip is punctured. Therefore, it is possible to more reliably prevent the blade tip of the needle body 141 from piercing the fingertip deeper than necessary.

Further, a mechanism for adjusting the moving distance of the plunger 41 described later may be provided to adjust the puncturing depth of the fingertip by the cutting edge of the needle 141.

The outer peripheral portion of the first housing 15
Is fixedly mounted.

The second housing 16 is formed of a substantially cylindrical member, and has a lumen 161 formed therein.

At the tip of the second housing 16,
A contact portion 163 projecting in a ring shape is formed. The contact portion 163 is a portion where the fingertip is pressed, and inside the contact portion 163, a distal end opening (opening) 16 through which the lumen portion 161 is opened.
2 are formed. The outer peripheral edge of the distal end of the contact portion 163 has a shape suitable for exerting an effect of stimulating a peripheral portion of the puncture when pressed against a fingertip and relieving pain during puncture. Further, when the pressure is reduced by the pump 8, the shape is such that the inflow of air from between the tip of the contact portion 163 and the surface of the fingertip can be suppressed as much as possible. In addition,
The contact portion 163 may not be provided at the distal end of the second housing 16, and the distal end surface of the second housing 16 may constitute a flat surface.

The second housing 16 has a contact portion 163
A ring-shaped flange 164 protruding outward is formed on the outer peripheral portion near the base end of. This flange 1
Reference numeral 64 designates a position with respect to the housing 5 in a state in which the base end thereof abuts on the distal end of the housing 5 in a state of being mounted on the housing 5 described later.

A concave portion 165 is formed in the outer peripheral portion of the second housing 16, and a test paper fixing portion 17 on which a disk-shaped test paper 18 is installed is mounted in the concave portion 165.

The blood introduction guide 1 protruding toward the inner cavity 161 is provided on the inner peripheral surface of the second housing 16.
66 are formed. This blood introduction guide 166
It has a function of receiving blood (sample) flowing into the lumen 161 from the distal end opening 162 after the fingertip puncture.

In such a chip 13, a blood passage 19 is formed through the second housing 16 and the test paper fixing portion 17 to communicate the inner cavity 161 of the second housing 16 with the outside. The blood passage 19 is a flow passage for guiding blood obtained by puncturing to the test paper 18, and has a passage opening 191 opened to the inner cavity 161 and a passage opening 192 opened to the outside of the chip 13. ing. The passage opening 192 is located at the center of the test paper 18.

The blood introduction guide 166 is formed near the passage opening 191. For this reason, the blood received by the blood introduction guide 166 efficiently passes through the passage opening 1.
The blood is guided from 91 to the blood passage 19. This blood reaches the passage opening 192 by capillary action, and the blood reaches the passage opening 192.
Is supplied to the central portion of the test paper 18 installed so as to close the surface, and develops radially.

The test paper 18 has a reagent supported on a carrier capable of absorbing and developing 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 blood (sample). For example, in the case of blood glucose measurement, glucose oxidase (GOD)
And peroxidase (POD), for example, 4-aminoantipyrine, N-ethyl N- (2-hydroxy-3-
A color-forming agent (color-forming reagent) such as sulfopropyl) -m-toluidine; and those which react with blood components such as, for example, ascorbate oxidase, alcohol oxidase, and cholesterol oxidase, depending on the components to be measured. And the same coloring agent (coloring reagent). 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.

Such a chip 13 is connected to the housing 2 described above.
It is detachably attached (fitted) to the housing 5 (fitting portion 53) through one opening 212.

As shown in FIGS. 3 and 4, the housing 5 is formed of a bottomed cylindrical member having a wall 51 as a bottom, and a lumen (storage space) 52 is formed inside the housing. ing. A fitting portion 53 whose inner diameter is reduced in accordance with the shape of the outer periphery of the chip 13 is formed on the distal end side of the housing 5. The chip 13 is inserted into the fitting portion 53 and fitted (fixed). In FIGS. 3 and 4,
To facilitate understanding of the description, the structure of the chip 13 is simplified.

At the side of the housing 5, an air passage 54 for communicating the lumen 52 with the outside is formed.
Is connected to the pump 8 via a tube 81.
The air in the lumen 52 is supplied to the air passage 54 and the tube 81.
The inside of the cavity 52 (including the inside of the chip 13) is depressurized.

As shown in FIG. 5, one end of a tube 82 is connected to the middle of the tube 81, and the other end of the tube 82 is open to the outside of the main body 2. The tube 82 has flexibility and can be made of, for example, the same material as the tube 81.

An electromagnetic valve 26 for opening and closing (opening / closing) the flow path is provided in the middle of the tube 82.

When the solenoid valve 26 is closed (in the closed state), the reduced pressure state of the inner cavity 52 (including the inside of the chip 13) is maintained, and when the solenoid valve 26 is opened (when it is opened). A tube 82 in the lumen portion 52 in the decompressed state.
Air (atmosphere) from outside through the air passage 81 and the ventilation path 54
Is introduced, and the reduced pressure state is released or alleviated.

Therefore, the tube (flow path) 81,
The 82 and the electromagnetic valve 26 constitute a decompression releasing unit.

As shown in FIGS. 3 and 4, a hole 511 is formed in the wall portion 51 of the housing 5 at a substantially central portion thereof. A thin tube 65 having an orifice (passage) 651 formed therein is provided in the hole 511. Through the orifice 651, air flows between the lumen 52 provided on both sides of the thin tube 65 and a variable volume chamber 631 described later.

A ring-shaped seal ring (sealing member) 55 is fitted to the tip of the housing 5. Thereby, when the chip 13 is mounted on the housing 5, the chip 1
The base end of the third flange 164 and the seal ring 55 are in contact with each other, and the airtightness of the lumen 52 is maintained.

The seal ring 55 is made of an elastic material. Examples of such an elastic body include natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acryl rubber, ethylene-propylene rubber, hydrin rubber, urethane rubber, silicone rubber, and fluorine rubber And various thermoplastic elastomers such as styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, and fluororubber.

The housing 5 has a ring-shaped flange 56 protruding outward on the outer periphery of the base end thereof, and a cylindrical projection 59 formed at the base end thereof.

The puncturing means 4 is housed in the inner cavity 52 on the proximal side of the fitting portion 53 of the housing 5. The puncture means 4 moves the puncture needle 14 attached to it in the distal direction, and punctures the surface of the fingertip with the cutting edge of the needle body 141.

The puncturing means 4 includes a plunger 41 and a coil spring (biasing member) for biasing the plunger 41 in the distal direction.
And a coil spring (biasing member) 43 for biasing the plunger 41 in the proximal direction.

At the tip of the plunger 41, a cup-shaped needle holder 411 is provided. This needle holder 411
, The reduced diameter portion 143 of the puncture needle 14 is detachably fitted. At the base end of the plunger 41, an elastically deformable elastic piece 412 having a protruding locking portion 413 at the distal end is provided.

In the state before the tip 13 is mounted on the housing 5, that is, before the puncture needle 14 is mounted on the plunger 41 (see FIG. 3), the locking portion 413 is moved by the elastic force of the elastic piece 412. 3, which is urged upward in the middle to abut the inner peripheral surface of the housing 5. On the other hand, when the tip 13 is mounted on the housing 5, that is, when the puncture needle 14 is mounted on the plunger 41 (see FIG. 4), the locking portion 413 is formed so as to penetrate through the inside and outside of the housing 5. 57, which locks into its edge. Thereby, the movement of the plunger 41 in the tip direction is restricted. The opening 57 is closed by a flat sealing member (sealing member) 58, and the airtightness of the lumen 52 is maintained. The seal member 58 can be made of the same material as the seal ring 55.

A coil spring (spring for puncturing) 42 is installed on the base end side of the plunger 41, and both ends thereof are
It is in contact with plunger 41 and wall 51. on the other hand,
The coil spring (push-back spring) 43 includes a plunger 41.
And both ends thereof are in contact with the plunger 41 and the fitting portion 53, respectively.

Further, as shown in FIG.
A pressure sensor 27 is installed in the inside of the housing 5.
3 (including the pressure in 3). Information from the pressure sensor 27, that is, the pressure (data) detected by the pressure sensor 27 is input to the control unit 11.

As shown in FIGS. 3 and 4, outside the housing 5, a drive source electrically driven is provided.
A solenoid 28 is provided. This solenoid 28
Are arranged so that the locking portion 413 can be moved toward the inside of the lumen portion 52 (in the direction of the arrow in the figure) by the plunger 281.

When the locking portion 413 is locked in the opening 57, the coil spring 42 is in a compressed state and urges the plunger 41 toward the distal end. The plunger 281 of the solenoid 28 moves in the direction of the arrow in FIG.
When the locking state of the locking portion 413 is released by 81, the coil spring 42 expands and moves the plunger 41 in the distal direction, and the cutting edge of the needle 141 pierces the surface (skin) of the fingertip. Therefore, the solenoid 28 constitutes an operation start means for starting the operation of the puncture means 4.

On the other hand, at this time, the coil spring 43 is compressed and urges the plunger 41 in the proximal direction, that is, tries to push the plunger 41 back in the proximal direction. afterwards,
The plunger 41 performs a damping movement, and stops at a position where the elastic force of the coil spring 42 and the elastic force of the coil spring 43 are balanced.

When the plunger 41 is stationary, the cutting edge of the needle 141 is housed in the tip 13.

A tip retracting mechanism 6 is provided at the base end of the housing 5. The chip retracting mechanism 6 moves the housing 5 and the chip 13 attached thereto in a direction away from the fingertip 200 (base end direction).

The tip retracting mechanism 6 has a main body 61, a seal ring 64, and a thin tube 65, as shown in FIGS.

The main body 61 is formed of a bottomed cylindrical member having a wall 62 as a bottom, and has a lumen 63 formed therein. The proximal end side of the housing 5 is inserted into the lumen 63.

At the tip of the main body 61, a ring-shaped convex portion 611 protruding toward the center thereof is formed. In the state before the tip retreat mechanism 6 is operated, the protrusion 611
And the distal end of the flange 56 are in contact with each other. Thereby, the movement of the housing 5 in the distal direction is restricted. That is, it is possible to prevent the housing 5 from falling out of the main body 61.

At this time, the tip of the contact portion 163 is
It is almost the same position as the finger contact surface 31 or the finger contact surface 3
1 (see FIG. 5). Thus, when the fingertip 200 is brought into contact with the finger contact portion 3, the surface of the fingertip 200 is reliably brought into contact with the contact portion 163, and the tip opening 162 can be closed.

The wall portion 62 has a substantially central portion formed with a concave portion 621 having a circular cross section. The diameter of the concave portion 621 is set substantially equal to the outer diameter of the convex portion 59, and the convex portion 59 is inserted into the concave portion 621. The outer diameter of the flange 56 is set substantially equal to the inner diameter of the main body 61. By adopting such a configuration, regardless of the axial position of the housing 5, for example, a vertical displacement in the figure (a displacement between the center of the housing 5 and the main body 61) can be more reliably prevented. .

The outer periphery of the projection 59, that is, the housing 5
A ring-shaped seal ring 64 is provided between the base end of the wall portion 62 and the surface 622 on the distal end side of the wall portion 62. The seal ring 64 is in airtight contact with each of the base end of the housing 5 and the surface 622. Thus, an airtight variable volume chamber (decompression chamber) 631 is defined in a region surrounded by the seal ring 64, the base end of the housing 5, the surface 622, and the inner surface of the recess 621.

The seal ring 64 is made of an elastic material and operates the tip retracting mechanism 6 (the state shown in FIG. 8).
Then, the housing 5 is urged in the distal direction by the elastic force. That is, the seal ring 64 also functions as an urging means. As such an elastic body, the same material as the seal ring 55 and the like can be used.

The thin tube 65 is formed of a cylindrical member, and has an orifice (passage) 651 formed therein. The orifice 651 is provided in the lumen 5 of the housing 5.
2 and the variable volume chamber 631 are communicated with each other. Such orifice 6
The diameter of 51 is not particularly limited.
It is preferably about 0.3 mm. Orifice 651
Is within the above range, a necessary and sufficient air passage (flow) resistance can be obtained.

By adjusting the diameter of the orifice 651, the timing of starting the operation of the pump 8 and the operation of the tip retracting mechanism 6 can be adjusted.

It should be noted that the thin tube 65 is not limited to the one shown in the figure, and the number of the thin tube 65 may be set as required.
There may be more than one.

In such a chip retracting mechanism 6, when the fingertip 200 is brought into contact with the contact part 163 and the pump 8 is operated with the tip end opening 162 sealed, first, the inner cavity 52
(Including the inside of the chip 13) is decompressed, and the air in the variable volume chamber 631 flows through the orifice 651 into the lumen 5.
2 and the pressure in the variable volume chamber 631 is started.
Since the air passage resistance of the orifice 651 is high, the volume of the variable volume chamber 631 gradually decreases, and the housing 5 and the chip 13 mounted thereon move gradually in the direction away from the fingertip 200.

Eventually, the base end 591 of the convex portion 59 and the concave portion 62
When the bottom surface of the housing 1 comes into contact with the housing 5, the movement of the housing 5 and the chip 13 mounted thereon toward the base end is stopped (see FIG. 9). Therefore, by adjusting the length of the protrusion 59 in the axial direction, it is possible to prevent the chip 13 from being unnecessarily separated from the fingertip 200. That is, the chip 1 is formed by the convex portion 59 and the bottom surface of the concave portion 621 abutting thereon.
Means (moving distance defining means) for defining the moving distance (maximum evacuation distance) from the third fingertip 200 is configured.

The distance between the tip 13 and the fingertip 200 (the maximum retreat distance of the tip 13) is not particularly limited, but is preferably, for example, about 0.2 to 3 mm, and 0.5 to 2.0 mm. More preferably, it is about 5 mm.
By setting the separation distance within the above range, a sufficient amount of blood can be secured more reliably and in a shorter time. In addition, it is possible to more reliably prevent the fingertip 200 from coming off the tip opening 162.

The tip retracting mechanism 6 operates following the operation of the pump 8. That is, the tip retracting mechanism 6
Reduces the pressure in the inner cavity 52 by the pump 8 and
After sucking the fingertip 200 at 62, the tip 13 is gradually retracted (moved) in the proximal direction. For this reason, the tip retracting mechanism 6 is configured to move the puncture site 2 of the fingertip 200.
While maintaining 10 in a reduced pressure state, the chip 13 is
Can be separated from.

The tip retracting mechanism 6 is provided with a pump 8
It operates using the decompression force generated by. In other words, the pump (decompression means) 8 can be said to be one of the components of the chip retracting mechanism 6.

Since such a chip retracting mechanism 6 does not require the addition of another driving source, it is advantageous for reducing the size, weight, and manufacturing cost of the component measuring device 1.

In the component measuring device 1, as shown in FIG. 6, when the fingertip 200 is pressed against the finger contact portion 3, the surface of the fingertip 200 comes into contact with the tip of the contact portion 163. Capillaries around the puncture site 210 are compressed by the tip of the part 163, but as shown in FIG.
Since the tip 13 can be separated from the fingertip 200 while maintaining the puncture site 210 at a reduced pressure, the capillaries around the puncture site 210 that have been pressed by the tip of the contact portion 163 are opened, Blood 220 is more reliably drawn out of puncture site 210 in a short time, and a sufficient and necessary blood volume for measuring the glucose amount can be secured.

The operating state of the chip retracting mechanism 6 (FIG. 9)
), The housing 5 moves in the proximal direction,
The seal ring 64 is in a compressed state. As described above, since the seal ring 64 is made of an elastic body, the seal 5 urges the housing 5 in the distal direction in the state shown in FIG. Therefore, when the solenoid valve 26 is opened to release the reduced pressure state, the seal ring 64 returns to the substantially original shape by its own elastic force, and moves the housing 5 toward the distal end (see FIGS. 10 and 11). At this time, the housing 5
The distal end of the flange 56 abuts on the base end of the convex portion 611 of the main body 61, and further movement in the distal direction is restricted (see FIG. 11). That is, the housing 5 and the chip 13 mounted thereon return to the position before the operation of the chip retreat mechanism 6.

Next, the operation of each part and the control operation of the control means when performing puncture, blood collection, expansion and blood sugar level measurement using the component measuring apparatus 1 will be described with reference to the flowcharts shown in FIGS. This will be described with reference to FIG.

[1] First, the tip 13 is inserted into the fitting portion 53 of the housing 5 through the opening 212 of the housing 21, and the reduced diameter portion 143 of the puncture needle 14 is fitted to the needle holder 411 (FIG. 4).

Further, when the tip 13 is pushed in the proximal direction, the plunger 41 is pressed against the urging force of the coil spring 42.
Moves in the proximal direction. The locking portion 413 includes an elastic piece 412.
And is in contact with the inner peripheral surface of the lumen 52 when the locking portion 413 comes to the position of the opening 57 (see FIG. 4). As a result, even if the pressing force in the proximal direction by the tip 13 is released, the locking portion 4
13 is locked in the opening 57, and the movement of the plunger 41 in the distal direction is restricted. At this time, the coil spring 42 is in a compressed state. In this state, preparation for puncturing by the puncturing means 4 and preparation for blood (sample) collection are completed.

[2] Next, a power switch (not shown) is turned on. Thereby, each part of the component measuring device 1 is activated and becomes in a measurable state. Note that the solenoid valve 26 is closed.

[3] Next, the fingertip (finger) 2
Press 00. Thereby, the contact portion 1 of the chip 13
The fingertip 200 is crimped to 63. At this time, the tip opening 162 is closed with the fingertip 200 so as to minimize air leakage (see FIG. 5).

[4] Next, the operation button 222 is pressed to operate the component measuring device 1. As a result, FIG.
3 is executed.

First, prior to puncturing, the control means 11
The pump 8 is operated to start suctioning air in the lumen 52 (including the inside of the chip 13) of the housing 5 (Step S101 in FIG. 13).

As a result, when there is no problem, the pressure of the lumen portion 52 (including the inside of the chip 13) is reduced, and the pressure is reduced (see FIG. 6). At this time, fingertip 2
The puncture site 210 of the 00 needle 141 is also in a decompressed state. However, in this state, the fingertip 200 located inside the contact portion 163 (the tip opening 162) swells toward the inside of the chip 13 in a hill shape, and the contact portion 163
Around the puncture site 210 where the tip of the
Capillaries are compressed.

Next, the pressure in the inner cavity 52 (including the inside of the chip 13) of the housing 5 is detected by the pressure sensor 27 (step S102 in FIG. 13).

Next, the control means 11 controls the pressure sensor 27
It is determined whether or not the lumen portion 52 (including the inside of the chip 13) has been decompressed, that is, whether or not the pressure has been reduced to a predetermined pressure (OK). (Step S103 in FIG. 13).

In step S103, the pressure OK
If not, it is determined whether or not the time is up (step S104 in FIG. 13).

If it is determined in step S104 that the time is not up, a position correction notification is performed (step S105 in FIG. 13).

In this step S105, the position of the finger applied to the finger application unit 3 is to be corrected, for example, displayed on the display unit 12 or informed by voice through the audio output unit 32. It goes without saying that this may be performed by both the display unit 12 and the audio output unit 32.

The operator (user) can know the situation by this position correction notification, move the finger position to an appropriate position so that air leakage is reduced as much as possible, and change the finger position. To a proper posture.

After executing step S105, the process returns to step S102, and executes step S102 and subsequent steps again. If it is determined in step S104 that the time is up, an error is notified (step S106 in FIG. 13). Further, the pump 8 is stopped, and the solenoid valve 26 is once opened and closed again.

In this step S 106, the error is displayed on the display unit 12, for example, or the audio output unit 32 notifies the user of the error. In addition, this is displayed on the display unit 12.
It goes without saying that the processing may be performed by both the voice output unit 32 and the audio output unit 32.

The operator (user) can recognize from the error notification that an error has occurred (there is a problem).

[5] In the step S103,
If it is determined that the pressure is OK, the surface of fingertip 200 is punctured (step S107 in FIG. 13).

That is, the control means 11 controls the solenoid 2
8 is energized. Thereby, the plunger 281 of the solenoid 28 moves in the direction of the arrow in FIG. 4, abuts the locking portion 413, and pushes it back toward the lumen 52. Accordingly, the locking of the locking portion 413 is released, the plunger 41 moves in the distal direction by the elastic force of the compressed coil spring 42, and the needle body 141 protrudes from the distal opening 162,
The surface of the fingertip 200 is punctured (see FIG. 7). Needle 141
Bleeding occurs from the puncture site 210 due to.

After the needle 141 punctures the fingertip 200,
The coil spring 43 pushes the plunger 41 back in the proximal direction. The plunger 41 undergoes a damping motion, and the coil spring 42
At a position where the elastic force of the coil spring 43 balances the elastic force of the coil spring 43 (see FIG. 8). At this time, the cutting edge of the needle 141 is housed in the tip 13. As described above, the cutting edge of the needle 141 does not protrude from the distal end opening 162 except at the time of puncturing, so that it does not accidentally injure the skin and the like, and can also prevent infection, thereby improving safety. high.

[6] The suction of the air in the inner cavity 52 by the pump 8 is continued, and the air in the variable volume chamber 631 gradually flows into the inner cavity 52 through the orifice 651 to change the volume. The volume of the chamber 631 gradually decreases. As a result, the housing 5 and the chip 13 attached thereto move in the proximal direction, that is, the fingertip 2
Movement is gradually started in a direction away from 00.

At this time, since the decompressed state of the lumen portion 52 and the puncture site 210 of the fingertip 200 is maintained, the fingertip 200 does not come off from the distal end opening 162. Further, even if the chip 13 moves in the direction away from the fingertip 200, the fingertip 200 does not move following the chip 13 because it is in contact with the finger rest 3. Therefore, the chip 13 is securely separated from the fingertip 200.

When the tip 13 is separated from the fingertip 200, the capillaries around the puncture site 210, which have been pressed by the tip of the contact portion 163, are gradually opened, and blood 220 is sucked out of the puncture site 210. (See FIG. 9). That is, bleeding is promoted as compared with a case where the fingertip 200 and the chip 13 are not separated from each other, and a necessary blood volume can be secured in a short time.

The minimum pressure generated by the pump 8 is preferably, for example, about 100 to 400 mmHg.

Eventually, the base end 591 of the convex portion 59 and the concave portion 62
1 contacts the bottom surface. As a result, the movement of the housing 5 and the tip 13 attached thereto in the proximal direction is stopped. As described above, since the tip 13 stops when the tip 13 is separated from the fingertip 200 by an appropriate distance, the fingertip 200 does not come off from the distal end opening 162. Therefore, it is possible to more reliably prevent the blood 220 sucked from the puncture site 210 from scattering and contaminating the surroundings, and the safety is high.

As described above, in the component measuring device 1, the puncturing operation and the depressurizing operation are performed by one press of the operation button 222, and the retracting operation of the tip 13 is performed by the pump 8
This is performed by utilizing the depressurizing force of the above, and the decompression releasing operation described later is also automatically started, so that the operability is extremely good.

[7] In the operation of [6], the puncture site 2
The blood 220 that has been raised in a granular manner on the blood 10 is sucked into the chip 13, and the blood introduction guide 166 formed inside the chip 13.
To the test paper 18 through the blood passage 19,
It is supplied to the center of the test paper 18 and developed radially (see FIG. 2).

As the blood 220 is supplied to and spread on the test paper 18, glucose (a component to be measured) in the blood 220 reacts with the reagent carried on the test paper 18, and the test paper 18
Is colored according to the amount of glucose.

On the other hand, after executing the step S107 shown in FIG. 13, the control means 11 drives the measuring means 7 and monitors the coloration of the test paper 18 via the measuring means 7 (monitor).
Then, it is determined whether or not blood has been collected (step S108 in FIG. 13).

In step S108, when the voltage level of the signal input from the light receiving element 72 of the measuring means 7 exceeds a preset threshold value, it is determined that blood has been collected, and If the voltage level is below the threshold, it is determined that blood has not been collected.

The threshold value is sufficiently higher than the voltage level of the signal before the test paper 18 is colored, and
The value is set to a value sufficiently smaller than the voltage level of the signal when the color is displayed.

If it is determined in step S108 that blood has not been collected, it is determined whether or not the time is up (step S109 in FIG. 13).

In step S104, if it is determined that the time is not up, the process returns to step S108, and steps S108 and subsequent steps are executed again. If it is determined that the time is up, an error is notified (FIG. 13).
Step S110), the pump 8 is stopped, the solenoid valve 26 is once opened to release the reduced pressure state, and the solenoid valve 26 is closed again.

In this step S106, the error is displayed on the display unit 12 or the audio output unit 32 notifies the error by voice. In addition, this is displayed on the display unit 12.
It goes without saying that the processing may be performed by both the voice output unit 32 and the audio output unit 32.

The operator (user) can know from the error notification that the error is an error (there is a problem).

If it is determined in step S108 that blood has been collected, the pump 8 is stopped.
That is, the suction of the air in the lumen 52 by the pump 8 is stopped (step S111 in FIG. 13).

Next, the solenoid valve 26 is opened to release the reduced pressure state (step S112 in FIG. 13).

When the solenoid valve 26 is opened, the tubes 82, 81
Outside air (atmosphere) flows into the lumen portion 52 (including inside the chip 13) and the puncture site 210 via the ventilation path 54, and the lumen portion 52 (including inside the chip 13) and the puncture site 210 become large. It returns to the atmospheric pressure (see FIG. 10).

Further, the seal ring 64 returns to a substantially original shape by its own elastic force, and moves the housing 5 toward the distal end (see FIGS. 10 and 11). At this time, the distal end of the flange 56 of the housing 5 comes into contact with the proximal end of the convex portion 611 of the main body 61, and further movement in the distal direction is restricted (see FIG. 11).

When it is confirmed that there is no sense of suction around the puncture site 210 of the fingertip 200 and the pressure returns to the atmospheric pressure, the contact portion 163 of the chip 13 is separated from the fingertip 200.

[8] After executing the step S112 shown in FIG. 13, the control means 11 measures the degree of coloration of the test paper 18 by the measuring means 7, performs an arithmetic process based on the obtained data, Correction such as correction calculation and hematocrit value correction calculation is performed to quantify the blood sugar level (step S113 in FIG. 13).

In this case, since the depressurized state of the inner cavity 52 (including the inside of the chip 13), that is, the depressurized state of the storage space for the test paper 18, has been released, the glucose (the component to be measured) in the blood 220 ) And the components (eg, oxygen, carbon dioxide, water vapor, etc.) in the atmosphere necessary for the reaction between the reagent carried on the test paper 18 are sufficiently supplied, whereby the blood glucose level can be accurately measured.

Next, the calculated blood sugar level is displayed on the display unit 1.
2 (step S114 in FIG. 13).

Thus, the blood sugar level can be grasped. After the decompression state is released in step S112, the electromagnetic valve 26 is closed again in preparation for the next measurement.

As described above, this component measuring device 1
According to the method, a sufficient amount of blood necessary and sufficient for measurement can be collected in a short time, and a blood sugar level (amount of a predetermined component in blood) can be accurately and reliably measured.

Prior to puncturing, decompression is attempted, and only when the decompression state is confirmed, puncturing means 4 is operated to perform puncturing. Therefore, it is possible to prevent unnecessary finger puncturing. It is possible to reduce the burden on the patient.

Further, since the test paper 18 is provided on the chip 13, puncturing, blood collection, development on the test paper 18, and measurement (quantification of components) can be performed continuously.
Blood glucose measurement (component measurement) can be performed easily and in a short time.

Further, the preparation operation at the time of use is easy, and therefore, it is advantageous even when it is used regularly or repeatedly.

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 14 is not directly visible, fear of puncturing is reduced.

As described above, this component measuring device 1
It is suitable for use when the patient himself measures his or her blood glucose level.

The component measuring device 1 has a simple structure, is small and lightweight, is inexpensive, and is suitable for mass production.

Next, a second embodiment of the component measuring device of the present invention will be described. FIG. 14 shows a second example of the component measuring device of the present invention.
It is a flowchart which shows the control operation of the control means in embodiment. In addition, description about the common point with the component measuring device 1 of 1st Embodiment mentioned above is abbreviate | omitted, and a main difference is demonstrated.

The structure of the component measuring device 1 according to the second embodiment is the same as that of the component measuring device 1 according to the above-described first embodiment, and a description thereof will be omitted, and its operation will be described with reference to the flowchart shown in FIG. The following description focuses on differences from the component measuring apparatus 1 of the first embodiment described above.

In the component measuring device 1, the operation buttons 22
When pressing operation 2, the program shown in FIG. 14 is executed.

First, prior to puncturing, the control means 11
The pump 8 is operated to start suctioning air in the lumen 52 (including the inside of the chip 13) of the housing 5 (step S201 in FIG. 14).

Next, the pressure in the lumen 52 (including the inside of the chip 13) of the housing 5 is detected by the pressure sensor 27 (step S202 in FIG. 14).

Next, the control means 11 controls the pressure sensor 27
It is determined whether or not the lumen portion 52 (including the inside of the chip 13) has been decompressed, that is, whether or not the pressure has been reduced to a predetermined pressure (OK). (Step S203 in FIG. 14).

In step S203, the pressure OK
If it is determined that the error is not detected, an error notification is made (FIG. 1
4, step S204), the pump 8 is stopped, and the solenoid valve 26 is once opened and closed again.

In this step S204, the error is displayed on the display unit 12 or is notified by voice through the voice output unit 32, for example. In addition, this is displayed on the display unit 12.
It goes without saying that the processing may be performed by both the voice output unit 32 and the audio output unit 32.

The operator (user) can know from the error notification that an error has occurred (there is a problem).

In step S103, the pressure OK
If determined to be, the surface of the fingertip 200 is punctured (step S205 in FIG. 14).

Next, the control means 11 drives the measuring means 7, monitors (monitors) the color of the test paper 18 via the measuring means 7, and determines whether or not blood has been collected (FIG. 14). Step S206).

If it is determined in step S206 that no blood has been collected, it is determined whether or not the time is up (step S207 in FIG. 14).

In step S207, if it is determined that the time is not up, the process returns to step S206, and the steps from step S206 are executed again. If it is determined that the time is up, an error is notified (FIG. 14).
Step S208), the pump 8 is stopped, the solenoid valve 26 is once opened to release the reduced pressure state, and the solenoid valve 26 is closed again.

In this step S208, the error is displayed on the display unit 12 or is notified by voice through the voice output unit 32, for example. In addition, this is displayed on the display unit 12.
It goes without saying that the processing may be performed by both the voice output unit 32 and the audio output unit 32.

The operator (user) can know from the error notification that there is an error (that there is some trouble).

When it is determined in step S206 that blood has been collected, the pump 8 is stopped,
That is, the suction of the air in the lumen 52 by the pump 8 is stopped (step S209 in FIG. 14).

Next, the solenoid valve 26 is opened to release the reduced pressure state (step S210 in FIG. 14).

Next, the degree of coloration of the test paper 18 is measured by the measuring means 7, and arithmetic processing is performed based on the obtained data, and correction such as temperature correction calculation and hematocrit value correction calculation is performed to determine the blood glucose level. (Step S in FIG. 14)
211).

Next, the calculated blood sugar level is displayed on the display unit 1.
2 (step S212 in FIG. 14).

Thus, the blood sugar level can be grasped. After the decompression state is released in step S210, the solenoid valve 26 is closed again in preparation for the next measurement.

According to the component measuring device 1, the same effects as those of the component measuring device 1 of the first embodiment can be obtained.

Next, a third embodiment of the component measuring device of the present invention will be described. FIG. 15 shows a second example of the component measuring device of the present invention.
It is a flowchart which shows the control operation of the control means in embodiment. In addition, description about the common point with the component measuring device 1 of 1st Embodiment mentioned above is abbreviate | omitted, and a main difference is demonstrated.

The structure of the component measuring device 1 according to the third embodiment is the same as that of the component measuring device 1 according to the above-described first embodiment, and a description thereof will be omitted. The operation thereof will be described with reference to the flowchart shown in FIG. The following description focuses on differences from the component measuring apparatus 1 of the first embodiment described above.

In the component measuring device 1, the operation buttons 22
When the user presses No. 2, the program shown in FIG. 15 is executed.

First, prior to puncturing, control means 11
The pump 8 is operated to start sucking air in the lumen 52 (including the inside of the chip 13) of the housing 5 (step S301 in FIG. 15).

Next, the pressure in the lumen 52 (including the inside of the chip 13) of the housing 5 is detected by the pressure sensor 27 (step S302 in FIG. 15).

Next, the control means 11 controls the pressure sensor 27
It is determined whether or not the lumen portion 52 (including the inside of the chip 13) has been decompressed, that is, whether or not the pressure has been reduced to a predetermined pressure (OK). (Step S303 in FIG. 15).

In step S203, the pressure OK
If not, it is determined whether or not the time is up (step S304 in FIG. 15).

If it is determined in step S304 that the time is not up, a position correction notification is performed (step S305 in FIG. 15).

In step S 305, the fact that the position of the finger applied to the finger application unit 3 should be corrected is displayed on the display unit 12, or the audio output unit 32 notifies the user by voice. It goes without saying that this may be performed by both the display unit 12 and the audio output unit 32.

The operator (user) can know the situation by the position correction notification, move the finger position to an appropriate position so that air leakage is reduced as much as possible, and change the finger position. To a proper posture.

After executing the step S305, the process returns to the step S302, and the steps from the step S302 are executed again. If it is determined in the step S304 that the time is up, an error is notified (step S306 in FIG. 15). Further, the pump 8 is stopped, and the solenoid valve 26 is once opened and closed again.

In step S 306, the error is displayed on the display unit 12, or the audio output unit 32 notifies the user of the error. In addition, this is displayed on the display unit 12.
It goes without saying that the processing may be performed by both the voice output unit 32 and the audio output unit 32.

The operator (user) can know from the error notification that an error has occurred (there is a problem).

At the step S303, the pressure OK
When the determination is made, the pump 8 is stopped, that is, the suction of the air in the lumen 52 by the pump 8 is stopped (step S307 in FIG. 15).

Next, the solenoid valve 26 is once opened to release the reduced pressure state (step S308 in FIG. 15). After the pressure reduction state is released in step S308, the electromagnetic valve 26 is closed again.

Then, the surface of fingertip 200 is punctured (step S309 in FIG. 15). Next, the pump 8 is operated, and the lumen 52 of the housing 5 (including the inside of the chip 13)
The suction of the air in the inside is started (step S31 in FIG. 15).
0).

Next, the control means 11 drives the measuring means 7, monitors the coloration of the test paper 18 via the measuring means 7, and determines whether or not blood has been collected (FIG. 15). Step S311).

If it is determined in step S311, that no blood has been collected, it is determined whether or not the time is up (step S312 in FIG. 15).

In step S312, if it is determined that the time is not up, the process returns to step S311. Steps S311 and subsequent steps are executed again. If it is determined that the time is up, an error is notified (FIG. 15).
Step S313), the pump 8 is stopped, the solenoid valve 26 is once opened to release the reduced pressure state, and the solenoid valve 26 is closed again.

In step S 313, the error is displayed on the display unit 12, or the audio output unit 32 notifies the user of the error. In addition, this is displayed on the display unit 12.
It goes without saying that the processing may be performed by both the voice output unit 32 and the audio output unit 32.

The operator (user) can know from the error notification that an error has occurred (there is a problem).

If it is determined in step S311, that blood has been collected, the pump 8 is stopped.
That is, the suction of the air in the lumen 52 by the pump 8 is stopped (step S314 in FIG. 15).

Next, the solenoid valve 26 is opened to release the reduced pressure state (step S315 in FIG. 15).

Next, the degree of coloration of the test paper 18 is measured by the measuring means 7, and arithmetic processing is performed based on the obtained data, and correction such as temperature correction calculation and hematocrit value correction calculation is performed to determine the blood glucose level. (Step S in FIG. 15)
316).

Next, the calculated blood sugar level is displayed on the display unit 1.
2 (step S317 in FIG. 15).

As a result, the blood sugar level can be grasped. After the pressure reduction state is released in step S315, the electromagnetic valve 26 is closed again in preparation for the next measurement.

According to the component measuring device 1, the same effects as those of the component measuring device 1 of the first embodiment can be obtained.

In the component measuring device 1, when the reduced pressure state is detected, the reduced pressure state is temporarily released, and then the puncture is performed. Since the change in the amount of skin that swells due to pressure can be reduced, more accurate puncture can be performed with respect to the puncture depth.

[0220] In the present invention, for example, the steps S304 and S305 may be omitted.

Next, a fourth embodiment of the component measuring device of the present invention will be described. FIG. 16 shows a fourth example of the component measuring device of the present invention.
It is a longitudinal section showing an example of composition of an important section in an embodiment. The description of the common points with the component measuring device 1 of the first to third embodiments will be omitted, and the main differences will be described. In FIG. 16, the right side is referred to as a “base end” and the left side is referred to as a “distal end”.

The composition of the component measuring device 1 of the fourth embodiment is different from that of the component measuring devices 1 of the first to third embodiments described above in terms of the decompression releasing means.

That is, in the component measuring device 1, FIG.
As shown in FIG. 6, a thin tube 83 is provided instead of the electromagnetic valve 26 of the component measuring device 1 of the first to third embodiments described above.

The thin tube 83 is formed of a cylindrical member, and has an orifice (flow path) 831 formed therein. The thin tube 83 is joined (connected) to the end of the tube 82, and the tip of the thin tube 83 (orifice 831) is open to the outside of the main body 2.

Since the orifice 831 of the thin tube 83 has a small diameter, the air passage resistance is large. Although the diameter of such an orifice 831 is not particularly limited, for example, 0.01
It is preferably about 0.3 mm. Further, the length of the orifice 831 is not particularly limited, but is, for example, 5 to 5.
It is preferably about 15 mm. By setting the diameter of the orifice 831 within the above range, a necessary and sufficient air passage (flow) resistance can be obtained.

The tubes (flow paths) 81 and 82 and the thin tube 83 constitute a pressure reduction releasing means.

The number of the thin tubes 83 is not limited to the illustrated one, and the number of the thin tubes 83 and the number of orifices may be plural as necessary.

In the component measuring apparatus 1, the flow rate of the air sucked by the operation of the pump 8 is larger (larger) than the flow rate of the outside air (atmosphere) flowing from the orifice 831 of the thin tube 83. Then, the air in the lumen 52 of the housing 5 is sucked, whereby the pressure of the lumen 52 (including the inside of the chip 13) decreases,
The pressure is reduced.

Then, when the pump 8 stops, the thin tube 83
The outside air (atmosphere) flows into the lumen 52 (including the inside of the chip 13) and the puncture site 210 through the orifices 831, tubes 82, 81 and the air passage 54 of
(Including the inside of the chip 13) and the puncture site 210 are released from the reduced pressure state. That is, the lumen 52 (including the inside of the chip 13) and the puncture site 210 return to the atmospheric pressure.

According to the component measuring device 1, the same effects as those of the component measuring devices 1 of the above-described first to third embodiments can be obtained.

Although the component measuring device of the present invention has been described based on the illustrated embodiments, the present invention is not limited to these embodiments. Any configuration that can be obtained can be substituted.

Further, in the above embodiment, blood was used as a representative example of the body fluid to be collected. However, in the present invention, the body fluid to be collected is not limited to this. Good.

In the above embodiment, glucose (blood sugar level) was described as a representative component to be measured. However, in the present invention, the component to be measured is not limited to this. For example, protein, cholesterol, Inorganic ions such as uric acid, creatinine, alcohol, and sodium may be used.

Further, in the above embodiment, the measuring means measures the amount of the predetermined component. In the present invention, the measuring means may measure the property of the predetermined component. It may measure the amount and properties of a predetermined component.

In the present invention, the suction force of the pump 8 at the time of collecting blood, that is, the pressure in the storage space (lumen 52) of the puncture needle may be kept constant. May be changed).

FIGS. 17 and 18 show pressure patterns in the storage space (lumen 52) for the puncture needle when blood is collected.

In the present invention, for example, as shown in FIG. 17, the pressure in the storage space (lumen 52) for the puncture needle may be alternately switched between low pressure and high pressure, or as shown in FIG. Alternatively, the pressure in the storage space (lumen 52) for the puncture needle may be gradually increased. In this case, the timing of puncturing is not particularly limited.

By changing the pressure in the storage space (lumen 52), it is possible to collect a sufficient and sufficient amount of blood in a shorter time and more reliably.

In the above embodiment, the pressure sensor is used as the pressure detecting means. However, the present invention is not limited to this. For example, a position sensor may be used.

When a position sensor is used as the pressure detecting means, for example, a mark is put on the housing 5 and a position sensor such as a photo interrupter is installed on the housing 21 of the main body 2 so that the pressure changes. When the housing 5 is pulled into the chip retracting mechanism 6, it can be detected by the position sensor.

In the above-described embodiment, the blood sampling detecting means for detecting the blood sampling and the measuring means for measuring the amount of the predetermined component in the blood (in this embodiment, this means is referred to as "measuring means"). However, in the present invention, the blood sampling detecting means and the measuring means may be provided separately.

In the above embodiment, means for optically detecting blood sampling is used as the blood sampling detecting means. However, the present invention is not limited to this.
Means for electrically detecting may be used.

Further, in the present invention, when blood sampling detection means for optically detecting blood sampling is used, the color (coloring) of the test paper is detected by the reaction between the components in blood and the reagent as described above. In addition to the above, for example, a device that detects the introduction of blood into a blood passage (blood passage) that supplies blood to the test paper of the chip may be used.

When detecting the introduction of blood into the blood passage, for example, at least the vicinity of the blood passage of the chip is formed of a light-transmissive (transparent) member, and the blood collection detecting means The blood passage is irradiated with light, the reflected light or transmitted light is received, photoelectrically converted, and the output voltage from the blood collection / detection means is monitored by the control means. When blood is introduced into the blood passage, the color of the site changes to substantially red-black, whereby the amount of reflected light or transmitted light from the site changes, and the output voltage from the blood collection detection unit changes. Changes, the detection of the change in the output voltage (light quantity) is regarded as the detection of blood sampling.

The blood collection detecting means for electrically detecting the collection of blood includes, for example, a sensor (electrode) for detecting (measuring) the impedance of a blood passage or the like of a chip, a biosensor, and the like.

When the biosensor is used, for example, when blood is introduced into the blood passage, the output current from the biosensor changes. By detecting the change in the output current (current value), Detection of blood sampling.

In the case where a sensor for detecting the impedance is used, for example, when blood is introduced into the blood passage, the impedance between the electrodes of the sensor changes. Detection of blood sampling.

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 blood and the reagent as described above, and converts the measured value into a measured value. The present invention is not limited to the conversion and display. For example, a potential change generated according to the amount of the component in the sample may be electrically measured, converted to a measured value, and displayed.

Further, in the above-described embodiment, the reduced pressure state is released before the measurement, but in the present invention, the reduced pressure state may be relaxed before the measurement.

In the present invention, the operations of the pressure reducing means, the puncturing means, and the tip retreating mechanism may be started manually or automatically.

[0251]

As described above, according to the present invention, it is possible to reliably measure a predetermined component in a body fluid (for example, blood or the like) in a short time.

In particular, it is possible to prevent unnecessary puncturing of the epidermis, thereby reducing the burden on the patient.

When a test paper is provided on the chip,
Puncture, collection of blood, development on a test paper, and measurement (quantification of components) can be continuously performed, and component measurement can be performed easily and in a short time.

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

Further, accidents such as accidental puncture 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.

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.

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

[Brief description of the drawings]

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

FIG. 2 is a longitudinal sectional view showing a configuration example of a chip used in the present invention.

FIG. 3 is a longitudinal sectional view showing a configuration example of a puncturing means and a housing containing the puncturing means of the component measuring apparatus of the first embodiment (a state before a chip is mounted on the housing).

FIG. 4 is a vertical cross-sectional view (with a chip mounted on the housing) showing a configuration example of a puncturing means and a housing incorporating the puncturing means of the component measuring device of the first embodiment.

FIG. 5 is a longitudinal sectional view showing a configuration example of a main part in the component measuring device according to the first embodiment (a state before the operation of the pressure reducing unit and the puncturing unit).

FIG. 6 is a vertical cross-sectional view (a state when a pressure reducing unit is operated) showing a configuration example of a main part in the component measuring device of the first embodiment.

FIG. 7 is a longitudinal sectional view showing a configuration example of a main part of the component measuring device according to the first embodiment (a state when the puncturing means is operated).

FIG. 8 is a longitudinal sectional view showing a configuration example of a main part of the component measuring device according to the first embodiment (after puncturing and when the pressure reducing means is operating).

FIG. 9 is a vertical cross-sectional view showing a configuration example of a main part in the component measuring device according to the first embodiment (a state when the tip retracting mechanism is operated).

FIG. 10 is a longitudinal sectional view showing a configuration example of a main part in the component measuring device according to the first embodiment (a state when the decompression releasing means is operated).

FIG. 11 is a longitudinal sectional view (final state) showing a configuration example of a main part in the component measuring device of the first embodiment.

FIG. 12 is a block diagram illustrating a circuit configuration of the component measuring device according to the first embodiment.

FIG. 13 is a flowchart illustrating a control operation of a control unit of the component measuring device according to the first embodiment.

FIG. 14 is a flowchart illustrating a control operation of a control unit in the second embodiment of the component measurement device of the present invention.

FIG. 15 is a flowchart showing a control operation of a control unit in a third embodiment of the component measuring device of the present invention.

FIG. 16 is a longitudinal perspective view showing a main part in a fourth embodiment of the component measuring device of the present invention.

FIG. 17 is a graph showing a pressure pattern in a storage space (lumen portion 52) for a puncture needle when blood is collected in the present invention.

FIG. 18 is a graph showing a pressure pattern in a storage space (lumen 52) for a puncture needle when blood is collected in the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Component measuring apparatus 2 Main body 21 Housing 211 Wall part 212 Opening 22 Lid 221 Display window 222 Operation button 223 Lock release member 23 Storage space 3 Finger contact part 31 Finger contact surface 4 Puncturing means 41 Plunger 411 Needle holder 412 Elastic piece 413 Locking part 42 Coil spring 43 Coil spring 5 Housing 51 Wall part 511 Hole 52 Lumen part 53 Fitting part 54 Air passage 55 Seal ring 56 Flange 57 Opening 58 Seal member 59 Convex part 591 Base end 6 Chip retreat mechanism 61 Main part 611 Convex part 62 wall part 621 concave part 622 surface 63 lumen 631 variable volume chamber 64 seal ring 65 thin tube 651 orifice 7 measuring means 71 light emitting element 72 light receiving element 8 pump 81, 82 tube 83 thin tube 831 orifice 9 battery 10 circuit board 11 control Means 1 Display unit 13 Tip 14 Puncture needle 141 Needle body 142 Hub 143 Reduced diameter portion 15 First housing 151 Inner peripheral surface 152 Inner cavity 153 Wall 154 Hole 16 Second housing 161 Inner cavity 162 Tip opening 163 Contact portion 164 Flange 165 Recess 166 Blood introduction guide 17 Test paper fixing part 18 Test paper 19 Blood passage 191 Passage opening 192 Passage opening 24 Amplifier 25 A / D converter 26 Solenoid valve 27 Pressure sensor 28 Solenoid 281 Plunger 29 Switch 32 Audio output unit 33 Memory 34 External output unit 200 Fingertip 210 Puncture site 220 Blood S101 to S114 steps S201 to S212 steps S301 to S317 steps

Claims (11)

[Claims] 1. A component measuring device for collecting a body fluid through an epidermis and measuring a component of the body fluid, the hermetically sealed by applying an epidermis to the epidermis, and applying the epidermis to the epidermis. A space to be decompressed; a decompression means for decompressing the space;
Or measuring means for measuring the property, pressure detecting means for detecting the pressure in the space, and notifying means for notifying predetermined information, trying to depressurize the space by the depressurizing means, from the pressure detecting means A component measuring device configured to perform the notification by the notification unit based on the information of (1). 2. A component measuring device which is used by mounting a tip provided with a puncture needle, wherein said puncture needle pierces an epidermis applied to said puncture skin, said puncture needle being adapted to puncture the epidermis applied to said puncture portion. Puncturing means for operating the puncture needle, a pressure reducing means for reducing the pressure of the puncture site of the epidermis by the puncture needle together with the storage space for the puncture needle, a pressure detecting means for detecting the pressure of the storage space, and sampling from the puncture site. Measuring means for measuring the amount of the predetermined component in the blood, and notifying means for notifying predetermined information, the pressure reducing means attempts to decompress the storage space, and based on information from the pressure detecting means. A component measuring device configured to perform the notification by the notification unit. 3. A component measuring device to be used by mounting a tip provided with a puncture needle, wherein the puncture needle is adapted to puncture the epidermis applied to the puncture epidermis. Puncturing means for operating the puncture needle, a pressure reducing means for reducing the pressure of the puncture site of the epidermis by the puncture needle together with the storage space for the puncture needle, a pressure detecting means for detecting the pressure of the storage space, and sampling from the puncture site. Measuring means for measuring the amount of the predetermined component in the blood, and notifying means for notifying predetermined information, an attempt is made to reduce the pressure of the storage space by the pressure reducing means, The component measuring device is configured to, when a depressurized state is not detected, notify the error by the notifying unit. 4. A component measuring device which is used by mounting a tip provided with a puncture needle, wherein the puncture needle is adapted to puncture the epidermis applied to the epidermis to be punctured. Puncturing means for operating the puncture needle, a pressure reducing means for reducing the pressure of the puncture site of the epidermis by the puncture needle together with the storage space for the puncture needle, a pressure detecting means for detecting the pressure of the storage space, and sampling from the puncture site. Measuring means for measuring the amount of the predetermined component in the blood, and notifying means for notifying predetermined information, an attempt is made to reduce the pressure of the storage space by the pressure reducing means, When the depressurized state is not detected, the notifying unit notifies that the position of the epidermis applied to the abutting portion should be corrected, and also notifies the pressure detecting unit even after a lapse of a predetermined time. Ri when said reduced pressure of the storage space is not detected, the component measuring device characterized by being configured to notify that an error by the notifying means. 5. The puncture needle according to claim 2, wherein the puncture needle is operated by the puncture means when the pressure detecting means detects the decompression state of the storage space. Component measuring device. 6. A component measuring device to be used by mounting a tip provided with a puncture needle, wherein the puncture portion is adapted to puncture the epidermis to be punctured, and the puncture needle is adapted to puncture the epidermis applied to the puncture portion. Puncturing means for operating the puncture needle, a pressure reducing means for reducing the pressure of the puncture site of the epidermis by the puncture needle together with the storage space for the puncture needle, a pressure detecting means for detecting the pressure of the storage space, and sampling from the puncture site. And measuring means for measuring the amount of the predetermined component in the blood that has been tried, the decompression means attempts to decompress the storage space, if the pressure detection means detects the decompression state of the storage space, A component measuring device, wherein the puncture needle is operated by the puncture means. 7. A driving source that is electrically driven, and has an operation start unit that starts operation of the puncturing unit by driving the driving source, and a pressure reduction state of the storage space is detected by the pressure detection unit. 7. The component measuring device according to claim 5, wherein when the operation is started, the operation of the puncture means is started by the operation start means, and the puncture needle is operated by the puncture means. 8. The component measuring device according to claim 2, wherein the puncturing means has a plunger and an urging member for urging the plunger in a distal direction. 9. The plunger has a locking portion for restricting movement in the distal direction, and releases the locking of the locking portion in a state where the plunger is urged by the urging member, thereby allowing the plunger to move in the distal direction. The component measuring device according to claim 8, wherein the component is moved to and punctured by the puncture needle. And a drive source that is electrically driven; and an operation start unit that releases the locking of the locking unit by driving the drive source. The component measuring device according to claim 9, wherein when detected, the locking of the locking portion is released by the operation start means. 11. When the depressurized state of the storage space is detected by the pressure detecting means, the depressurized state is temporarily released, and thereafter, the puncture is performed, and the puncture needle is removed by the depressurizing means. The puncture site of the finger by the puncture needle is set in a reduced pressure state together with the storage space.
The component measuring device according to any one of the above.