JP2002085384A - Tip for component measuring device and component measuring device and system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a tip for a component measuring device capable of measuring a predetermined component in humor in a short time while ensuring safety, and a component measuring device and system. SOLUTION: The component measuring device is used as the tip 13 for the component measuring device is mounted in its housing 5; the device is composed mainly of a body, a finger rest, a lancing means 4 contained in the housing 5, a tip retracting mechanism, a pump, a solenoid valve, and a measuring means for detecting the sampling of blood and for measuring the predetermined component in the blood sampled. Each part of the tip 13 and each part of the component measuring device 1 are dimensioned to meet a relation of L1<L2 wherein L1 is the distance over which the reduced diameter portion (fitting portion) 143 of the tip 13 fits into the lancet holder 411 of a plunger 41 when the tip 13 not yet used is properly mounted in the housing 5 and L2 is the distance from the end (end opening 162) of an abutting portion 163 to the tip of the lancing needle 14 of the tip 13 under a stable condition after lancing.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

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

[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, while the fingertips are concentrated in capillaries and suitable for blood collection, the nerves are also concentrated and painful, which causes a great deal of pain and burden on the patient. 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 chip is mounted on the blood glucose measuring device, a fingertip is pressed against the tip of the chip, and the opening at the tip is sealed so as to maintain airtightness.

Next, after the fingertip is punctured with a puncture needle protruding from the distal end opening, the suction means is operated in this state to draw blood from the punctured site and collect the blood. And
The blood glucose level of the collected blood is measured by the measuring device.

However, in the blood glucose measuring device, when a used chip is mounted on the blood glucose measuring device, the needle tip of the puncture needle projects from the tip opening of the chip at the time of mounting. There is a possibility that the surface of a living body such as a fingertip may be punctured by the needle tip by mistake.

[0011]

SUMMARY OF THE INVENTION An object of the present invention is to provide a highly safe component measuring device chip, a component measuring device, and a component which can reliably measure a predetermined component in a body fluid in a short time. To provide a measurement system.

[0012]

This and other objects are achieved by the present invention which is defined below as (1) to (26).

(1) A component measuring device chip which is used by being attached to a component measuring device for measuring a component of a bodily fluid collected by puncturing the epidermis with a puncture needle, provided at an inner cavity portion and at a tip end. A chip body having a contact portion with which the epidermis abuts, and is provided movably in a lumen of the chip body,
A puncture needle for puncturing the epidermis, when attempting to mount the component measurement device tip on the component measurement device, when the component measurement device chip is not properly mounted, and / or the component measurement device The tip for a puncture needle of the component measuring device tip is configured so as not to protrude from the contact portion when the tip for a component is used.

(2) A component measuring device chip having the puncture needle, which is used by being attached to a component measuring device for measuring a component of a bodily fluid collected by puncturing the epidermis with a puncture needle by a biasing means, A lumen body, a tip body provided at the distal end and having an abutting portion with which the epidermis abuts, and a movably provided lumen within the lumen of the tip body, supporting the puncture needle and the component measuring device And a lancet provided with a fitting portion for fitting to the urging means or the plunger urged by the urging means of the component measuring device when the chip is mounted on the component measuring device. When the used component measuring device tip is properly mounted on the component measuring device, the fitting distance of the fitting portion is L1, and the urging means after the puncture needle punctures the epidermis In the stable state of When the distance from the tip of the contact portion to the tip of the puncture needle of the component measuring device tip is L2, L
A component measurement device chip configured to satisfy a relationship of 1 <L2.

(3) The tip body is provided with an introduction guide for receiving bodily fluids. When the distance from the tip of the contact portion to the tip of the introduction guide is L3, L2-L1> L3. The component measuring device chip according to the above (2), which is configured to satisfy the relationship.

(4) The component measuring device chip according to the above (2) or (3), further comprising a use preventing means for preventing a plurality of uses.

(5) When the component measuring device chip is mounted on the component measuring device, the use preventing means allows the fitting of the fitting portion when the component measuring device chip is not used. The chip according to the above (4), which is configured to prevent the fitting of the fitting portion when the component measuring device chip has been used.

(6) The contact portion has an opening formed at its tip so that the lumen is open, and the interior of the cavity is decompressed with the opening closed by the skin. The chip for a component measuring device according to any one of (1) to (5), wherein the tip is used by adsorbing the epidermis to the opening.

(7) The tip for a component measuring device according to any one of (1) to (6), wherein the tip of the puncture needle is movable to a position near or beyond the tip of the contact portion. .

(8) The chip for a component measuring device according to any one of (1) to (7), further comprising a test paper and a passage for supplying a body fluid to the test paper.

(9) The chip for a component measuring device according to the above (8), wherein the test paper is a test paper for measuring blood glucose.

(10) A tip body provided with an inner cavity portion and a contact portion provided at the distal end and contacting the epidermis, and a lancet movably provided in the inner cavity portion of the tip body to support a puncture needle. A component measuring device for measuring a component of a bodily fluid collected by puncturing the epidermis with the puncture needle, using the component measuring device chip having Puncture needle of the component measuring device tip when attempting to mount the component measuring device tip, when the component measuring device tip is not properly mounted, and / or when the component measuring device tip is already used. Wherein the stylus tip is configured not to protrude from the contact portion.

(11) A tip body having an inner cavity portion and a contact portion provided at the distal end and contacting the epidermis, and a lancet movably provided in the inner cavity portion of the tip body to support a puncture needle. A component measurement device for measuring a component of a bodily fluid collected by puncturing the epidermis with the puncture needle, wherein the component measurement device comprises a plunger and the plunger. Biasing means for biasing the plunger, wherein the lancet of the component measuring device tip is fitted to the biasing means or the plunger when the component measuring device tip is mounted on the component measuring device. Has a fitting portion, when the unused component measuring device chip is properly attached to the component measuring device,
The fitting distance of the fitting portion is L1, from the tip of the contact portion in the stable state of the urging means after the puncture needle pierces the epidermis to the tip of the puncture needle of the component measuring device tip. Wherein the distance of L2 is L2, the relationship L1 <L2 is satisfied.

(12) The contact portion has an opening formed at the tip thereof so as to open the cavity, and the interior of the cavity is decompressed while the opening is closed by the epidermis. The component measuring device according to the above (10) or (11), wherein the skin is adsorbed to the opening for use.

(13) The component measuring apparatus according to any one of (10) to (12), wherein the tip of the puncture needle is movable to a position near or beyond the tip of the contact portion.

(14) The component measuring device chip is
The component measuring device according to any one of the above (10) to (13), comprising a test paper and a passage for supplying a body fluid to the test paper.

(15) The component measuring device according to (14), wherein the test paper is a test paper for measuring blood glucose.

(16) The component measuring device chip is
The component measuring device according to any one of the above (10) to (15), further comprising use preventing means for preventing the use of the component a plurality of times.

(17) When the component measuring device chip is mounted on the component measuring device, the use preventing means permits the fitting of the fitting portion when the component measuring device chip is not used. The component measuring device according to the above (16), which is configured to prevent the fitting of the fitting portion when the component measuring device chip has been used.

(18) A tip body provided at an inner cavity and a distal end and having an abutting portion with which the epidermis abuts, and a lancet movably provided within the inner cavity of the tip body and supporting a puncture needle. A component measuring device chip having
A component measuring system comprising: a component measuring device mounted to use the component measuring device chip, and a component measuring device for measuring a component of a bodily fluid collected by puncturing the epidermis with the puncture needle. When attempting to mount the component measuring device chip, if the component measuring device chip is not properly mounted, and / or if the component measuring device chip has been used, the component measuring device chip A component measuring system, wherein a tip of a puncture needle of a tip is configured not to protrude from the contact portion.

(19) A component measuring device for measuring a component of a bodily fluid collected by puncturing the epidermis with a puncture needle by an urging means, and a component measuring device mounted on the component measuring device and having the puncture needle A component measuring system comprising: a component tip; wherein the component measuring device has a plunger urged by the urging means, and the component measuring device tip is provided at a lumen and at a tip end. A tip body having an abutting portion with which the epidermis abuts, and a movably provided inside the lumen of the tip body, supporting the puncture needle, and mounting the component measuring device chip on the component measuring device. And a lancet provided with a fitting portion to be fitted to the plunger when the component measuring device tip is properly mounted on the component measuring device. Fit L1 was the joint distance, and L2 was the distance from the tip of the contact portion to the tip of the puncture needle of the component measuring device tip in a stable state of the urging means after the puncture needle punctured the epidermis. In a case, the component measurement system is configured to satisfy a relationship of L1 <L2.

(20) An introduction guide for receiving a body fluid is provided on the tip body of the component measuring device tip, and a distance from the tip of the contact portion to the tip of the introduction guide is L3. , L2−L1> L3, the component measurement system according to the above (19), which is configured to satisfy the relationship:

(21) The contact portion has an opening formed at the tip thereof so as to open the cavity, and the interior of the cavity is decompressed while the opening is closed by the epidermis. The component measuring device according to any one of the above (18) to (20), wherein the device is used by adsorbing the epidermis to the opening.

(22) The component measuring apparatus according to any one of (18) to (21), wherein the tip of the puncture needle is movable to a position near or beyond the tip of the contact portion.

(23) The component measuring device chip is as follows:
The component measuring device according to any one of (18) to (22), further including a test paper and a passage for supplying a body fluid to the test paper.

(24) The component measuring apparatus according to the above (23), wherein the test paper is a test paper for measuring blood glucose.

(25) The component measuring device chip comprises:
The component measuring device according to any one of the above (18) to (24), further comprising a use blocking means for blocking the use of the component a plurality of times.

(26) When the component measuring device chip is mounted on the component measuring device, the use preventing means allows the fitting of the fitting portion when the component measuring device chip is not used. The component measuring device according to the above (25), wherein when the component measuring device chip has been used, the fitting of the fitting portion is prevented.

[0039]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, a chip for a component measuring device, a component measuring device and a component measuring system according to the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

The component measuring device chip, the component measuring device, and the component measuring system of the present invention puncture the epidermis (skin), and puncture the body fluid from the punctured site (hereinafter, blood will be described as a representative in the present embodiment). This is a device that collects and measures a predetermined component of the body fluid.

The puncture site of the epidermis is preferably a finger, but may be, for example, a palm, a back of a hand, a side of a hand, an arm,
Thighs and the like.

In the following embodiments, a chip for a component measuring device, a component measuring device, and a component measuring system that puncture a fingertip (finger) will be described as representatives.

FIG. 1 is a perspective view schematically showing an embodiment of a component measuring apparatus of the present invention, FIG. 2 is a longitudinal sectional view showing an embodiment of a chip for a component measuring apparatus of the present invention, and FIGS. 7 is a longitudinal sectional view showing a configuration example of a puncturing means included in the component measuring apparatus shown in FIG. 1 and a housing for incorporating the puncturing means, and a chip for the component measuring apparatus shown in FIG. 2, and FIGS.
1 is a longitudinal sectional view showing a configuration example of a main part in the component measuring device shown in FIG. 1, FIG. 13 is a block diagram showing a circuit configuration of the component measuring device shown in FIG. 1, and FIG. It is a flowchart which shows the control operation | movement of the control means of a component measuring apparatus (a part includes operation | movement etc. of an operator). In addition,
1 to 12, the right side is referred to as “base end”, and the left side is referred to as “distal end”.

As shown in FIGS. 1, 7 and 13, a component measuring device (blood component measuring device) 1 is housed in a main body 2, a finger pad 3 installed in the main body 2, and a housing 5. Puncturing means 4, a tip retracting mechanism 6 provided on the proximal end side of housing 5, and measuring means 7 for detecting collection of blood (body fluid) and measuring a predetermined component in the collected blood (body fluid). , A pump 8 for reducing the pressure in the housing 5, an electromagnetic valve 26 for releasing, relaxing or holding the reduced pressure in the housing 5, a battery (power supply) 9, and a circuit board 10.
It has a control unit 11 and a display unit 12 provided above.

The component measuring device 1 is used with a component measuring device chip (hereinafter simply referred to as a “chip”) 13 mounted thereon. The component measuring device 1 and the chip 13 constitute a component measuring system. 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 chip retracting mechanism 6, the measuring means 7, the pump 8, the solenoid valve 26, the battery 9, circuit board 10,
The control means 11 and the display unit 12 are housed respectively.

An opening 21 that penetrates the inside and outside of the housing 21 and has a circular cross section is formed in the wall 211 on the front end side of the housing 21.
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 a skin is applied) 3 formed around the outer periphery of the opening 212 and corresponding 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, lancet dextrose 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, operation guidance, and the like.

The operation button 2 is provided on the upper surface of the lid 22.
22 are installed. In the component measuring device 1, by pressing the operation button 222, the puncturing means
Subsequently, the pump (decompression means) 8 is configured to operate sequentially or almost simultaneously.

The power of the component measuring device 1 may be turned on by pressing the operation button 222.

On the lower side of the display section 12 in FIG.
The control means 11 including a microcomputer is 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. Also,
The control means 11 has a built-in arithmetic unit for calculating the amount of glucose in blood (blood sugar level) based on the 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 pressure reducing 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 connected to the inner 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.

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 electromagnetic valve 26, the control unit 11, the display unit 12, and the like, and supplies power required for the operation thereof.

In front 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 (photo diode) 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 operates according to 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 side 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 (left and right directions 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 comprises a puncture needle 14, a first housing 15 for slidably (movably) accommodating the puncture needle 14, and a first housing 15
, A chip body 130 composed of a second housing 16 installed on the outer peripheral portion, a test paper fixing portion 17 installed on the outer peripheral portion of the second housing 16, and a test fixed on the test paper fixing portion 17. Paper 18.

The puncture needle 14 includes a needle 141 and a needle 141.
Lancet 142 fixed to the base end side of
The first housing 15 is slidably (movably) housed in the inner cavity 152.

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, and 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 lancet 142 is formed of a substantially columnar member, supports the needle body 141, and slides while its outer peripheral portion is in contact with the inner peripheral surface 151 of the first housing 15.

A reduced diameter portion (fitting portion) 143 having a reduced diameter is formed at the base end of the lancet 142. The reduced diameter portion 143 is fitted with a lancet holder 411 of the plunger 41 constituting the puncturing means 4 described later.

The first housing 15 is formed of a cylindrical member having a bottom with the 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. When the fingertip (finger) is punctured, the needle tip of the needle body 141 passes through the hole 154 and a lumen 161 of the first housing described later. Also,
The diameter of the hole 154 is set smaller than the outer diameter of the tip of the lancet 142. For this reason, the puncture needle 14 is
52, the distal end of the lancet 142 abuts against the proximal end of the wall portion 153.
Is prevented from moving toward the distal end.

Thus, when the tip of the needle 141 moves to a position near or beyond the tip of the abutting portion 163 described later, further movement in the tip direction is restricted.
That is, the needle tip of the needle body 141 is set so as to be movable to a position near or beyond the tip of a contact portion 163 described later.

Therefore, the needle body 141 has a constant projection length from the tip of the tip 13 when puncturing the fingertip,
It is possible to more reliably prevent the needle tip of the needle body 141 from puncturing 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.

On the base end side of the inner peripheral surface 151, a ring-shaped convex portion 155 projecting inward is formed.

When the tip 13 is not used, the outer periphery of the lancet 142 is locked and fixed to the projection 155. In this state, the needle tip of the needle 141 is
It is set not to protrude from.

The fixing force between the convex portion 155 and the lancet 142 allows the puncture needle 14 to be mounted (fitted) on the lancet holder 411 described later without any trouble, and the plunger 41 described later is fixed to the locking portion 413. It can be moved in the proximal direction without hindrance until it is inserted into the opening 57, and when the puncturing means 4 is operated, the projection 155
And the lancet 142 are easily released.

On the other hand, when the chip 13 has been used,
The fixing between the convex portion 155 and the lancet 142 is released.

When the chip 13 is not used, the protrusion 15
Since the lancet 142 is fixed to the component 5, when the chip 13 is mounted on the housing 5 of the component measuring device 1,
Fitting of the reduced diameter portion 143 to the lancet holder 411 is allowed, and the plunger 41 can be moved in the proximal direction so that the locking portion 413 can be inserted into the opening 57.

On the other hand, when the chip 13 has been used,
Since the fixing between the convex portion 155 and the lancet 142 is released, when the chip 13 is mounted on the housing 5 of the component measuring device 1, the lancet holder 41 of the reduced diameter portion 143.
1 is prevented, the plunger 41 cannot be moved in the proximal direction, and the locking portion 413 cannot be inserted into the opening 57.

Therefore, the projection 155 and the lancet 142 constitute means for permitting the same chip 13 to be used only once, that is, use preventing means for preventing the same chip 13 from being used a plurality of times. You.

The method of fixing the lancet 142 to the first housing 15 (use preventing means) is not limited to this. For example, a locking means may be provided on the inner peripheral surface 151 and / or the outer peripheral portion of the lancet 142. Provided or inner peripheral surface 1
A material that utilizes (uses) a frictional force between the outer peripheral portion of the lancet 142 and the lancet 142, or that weakly adheres or fuses the inner peripheral surface 151 to the lancet 142 may be used.

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,
The contact portion 163 is formed in an annular shape such as an annular shape (ring shape) and protrudes toward the distal end. The contact portion 163 is a portion against which a fingertip is pressed, and has a distal end opening (opening) 162 to which the lumen portion 161 opens at the distal end.
Are formed.

The tip 13 is used while the distal end opening 162 is closed with a fingertip, the pressure in the inner cavity 161 is reduced by the pump 8, and the fingertip is sucked into the distal end opening 162.

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 reducing pain at the time of puncture. When the pressure is reduced by the pump 8, the contact portion 16
3 has such a shape as to minimize the inflow of air from between the tip of the finger and the surface of the fingertip.

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.

The shape of the contact portion 163 is not limited to the one shown in the figure, and may be, for example, a flat surface having no step with respect to the front end surface of the flange 164.

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 set is mounted in the concave portion 165.

[0096] On the inner peripheral surface of the second housing 16, the blood introduction guide 1 protruding toward the inner cavity 161 is provided.
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 (passage) 19 for communicating the inner cavity 161 of the second housing 16 with the outside is formed through the second housing 16 and the test paper fixing portion 17. I have. 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 the chip 1.
3 and a passage opening 192 that opens to the outside. 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 cylindrical member having a bottom with a wall 51 as a bottom, and has a lumen (storage space) 52 formed therein. 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). 3 to 6, the structure of the chip 13 is simplified for easy understanding of the description.

An air passage 54 is formed on the side of the housing 5 for communicating the lumen 52 with the outside.
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. 7, 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.

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

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 body. 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 fluoro 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 on the base end thereof.

The puncturing means 4 is housed in the 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 comprises a plunger 41 and a coil spring (urging means) for urging the plunger 41 in the distal direction.
42 and a coil spring (biasing means) 43 for biasing the plunger 41 in the proximal direction.

At the tip of the plunger 41, a cup-shaped (tubular) lancet holder 411 is provided.
The reduced diameter portion 143 of the puncture needle 14 is detachably fitted to the lancet holder 411. That is, the reduced diameter portion 14
3 is inserted into the lancet holder 411, the lancet holder 411 is slightly pushed open, and the
Thus, the reduced diameter portion 143 is securely fitted and fixed to the lancet holder 411.

Note that the lancet holder 411 has:
For example, a slit may be formed.

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 a 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.

As shown in FIGS. 3 and 4, on the outside of the housing 5, an unlocking part 413 can be moved toward the inside of the lumen 52 (in the direction of the arrow in the figure). A member 223 is provided. This locking release member 2
23 moves in conjunction with the pressing of the operation button 222 described above.

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 in the distal direction. Press the operation button 222 to move the unlocking member 223 in the direction of the arrow in the figure,
When the locking state of the locking portion 413 is released, the coil spring 42 is released.
Is extended to move the plunger 41 in the distal direction, and the cutting edge of the needle 141 pierces the surface (skin) of the fingertip.

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.

Thereafter, the plunger 41 performs a damping movement,
As shown in FIG. 5, the coil spring 42 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 in a stationary state (stable state), the cutting edge of the needle 141 is
Is housed inside.

As shown in FIG. 4, when the unused chip 13 is properly mounted on the housing 5 of the component measuring device 1, the reduced diameter portion (fitting portion) 143 of the chip 13 and the plunger 41 Of the lancet holder 411 is L1.

As shown in FIG. 5, when the unused tip 13 is properly mounted on the housing 5 of the component measuring device 1, the tip (not shown) of the contact portion 163 in the stable state after the puncturing is performed. Let L2 be the distance from the tip opening 162) to the tip of the puncture needle 14 of the tip 13.

The chip 13 and the component measuring device 1
<Dimensions of each part are set so as to satisfy the relationship of L2.

As a result, for example, as shown in FIG.
When the used tip 13 removed from the housing 5 is mounted on the housing 5 again, or during the mounting, the tip of the puncture needle 14 is moved from the tip (tip opening 162) of the contact portion 163. Does not protrude. That is, the tip of the puncture needle 14 is stored in the tip body 130.

Similarly, for example, when an unused chip 13 is mounted on the housing 5, if the chip body 13
Even when the tip 13 is not properly attached to the housing 5, such as when the fixing of the ridge 155 and the lancet 142 has been released, the tip of the puncture needle 14 is kept in contact with the contact portion 1.
63 does not protrude from the tip. That is, the tip of the puncture needle 14 is stored in the tip body 130.

As described above, when the chip 13 and the component measuring device 1 attempt to mount the chip 13 on the housing 5, the chip 13 is not properly mounted,
When 3 is used, the tip of the puncture needle 14 of the tip 13 is configured not to protrude from the distal end (the distal end opening 162) of the reduced diameter portion 143.

Therefore, accidents such as accidentally puncturing the surface of a living body with the tip of the puncture needle 14 are prevented, and the safety is high.

The fitting distance L1 is not particularly limited, but is preferably about 0.3 to 10 mm,
More preferably, it is about 5 mm.

Further, the distance L2 is not particularly limited.
It is preferably about 0.5 to 20 mm, and 1 to 10 m
m is more preferable.

The difference between the distance L2 and the fitting distance L1 (L
2-L1) is preferably 0 mm <L2-L1 <10
mm, more preferably 2 mm <L2-L1 <5 mm.

By setting the difference between the distance L2 and the fitting distance L1 as described above, safety is further improved, and when the tip 13 is mounted on the housing 5, the reduced diameter portion 143 with respect to the lancet holder 411 is provided. Can be more reliably fixed (fitted), and it is advantageous for miniaturization.

The tip body 130 of the lancet holder 411 when the puncture needle 14 punctures the fingertip (epidermis)
The length of the part that fits inside or the unused tip 13
Is properly attached to the housing 5 of the component measuring device 1, the distance between the base end of the tip body 130 and the base end of the reduced diameter portion (fitting portion) 143 of the lancet 142 is L1 <L.
It is preferable that the setting is made so as to satisfy the relationship of 2.

The length of the portion of the lancet holder 411 that fits inside the chip body 130 is not particularly limited, but is preferably about 0.8 to 2.5 mm, and preferably 1 to 2.5 mm.
More preferably, it is about 1.5 mm.

As shown in FIG. 2, when the distance from the tip of the contact portion 163 (tip opening 162) to the tip of the blood introduction guide 166 is L3, the tip 13 and the component measuring device 1 It is preferable that the dimensions of each part are set so as to satisfy the relationship of L1> L3.

The distance L3 is not particularly limited.
It is preferably about 1 to 2 mm, and 1.3 to 1.8 m
m is more preferable.

A tip retracting mechanism 6 is provided on the base end side 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 tubular 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 projecting 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 slightly (see FIG. 7). 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 recess 621 having a circular cross section at a substantially central portion thereof. 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 body, and when the tip retracting mechanism 6 is in operation (the state shown in FIG. 10), the elastic force urges the housing 5 toward the distal end. 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 narrow 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 is to be noted that the thin tube 65 is not limited to the one shown in the figure.
There may be more than one.

In such a chip retreat mechanism 6, when the fingertip 200 is brought into contact with the contact portion 163 and the pump 8 is operated with the distal 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 5 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. 10). 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 convex portion 59 and the bottom surface of the concave portion 621 abutting on the convex portion 59 constitute a means (moving distance defining means) for defining the moving distance (maximum retreat distance) of the chip 13 from the fingertip 200.

The separation distance between the chip 13 and the fingertip 200 (the maximum retreat distance of the chip 13) is not particularly limited, but is preferably, for example, about 0.2 to 2.5 mm, and 0.5 to 2.5 mm. More preferably, it is about 1.5 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 includes 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 in reducing the size, weight, and manufacturing cost of the component measuring device 1.

In the component measuring device 1, as shown in FIG. 8, 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 portion 163, but the puncture site 21 of the fingertip 200 is compressed.
Since the tip 13 can be separated from the fingertip 200 while maintaining the pressure 0 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, and the blood 220 becomes more permeable. The blood is sucked out of the puncture site 210 surely and 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. 1)
0), the housing 5 moves in the proximal direction, and the seal ring 64 is compressed. As described above, since the seal ring 64 is formed 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 this depressurized 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. 11 and 12). 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. 12). 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, development 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, an unused chip 13 is inserted into the fitting portion 53 of the housing 5 through the opening 212 of the housing 21.
Insert When the tip 13 is not used, the outer peripheral portion of the lancet 142 is locked and fixed to the convex portion 155 of the tip body 130. Therefore, when the tip 13 is inserted into the fitting portion 53 of the housing 5, the puncture needle 14 Is fitted into the lancet holder 411 (see FIG. 4).

When the tip 13 is further pushed in 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.

On the other hand, when the chip 13 has been used,
Since the outer peripheral portion of the lancet 142 is not locked and fixed to the convex portion 155 of the tip main body 130, even if the tip 13 is mounted on the housing 5, the reduced diameter portion 143 of the puncture needle 14 is fitted to the lancet holder 411. In addition, the plunger 41 cannot be moved in the proximal direction, and the locking portion 413 cannot be inserted into the opening 57.
That is, preparation for puncturing by puncturing means 4 is not performed (see FIG. 6).

Therefore, the used chip 13 is not reused (the same chip 13 is prevented from being used more than once), and the chip 13 is safe.

As described above, even if the used tip 13 is mounted on the housing 5, the tip of the puncture needle 14 does not protrude from the tip (tip opening 162) of the abutting portion 163, so that it is safe and secure. (See FIG. 6).

[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. 7).

[4] Next, the operation button 222 is pressed to puncture the surface of the fingertip 200 (step S101 in FIG. 14).

When the operation button 222 is pressed, the unlocking member 223 connected to the operation button 222 moves downward in FIG. As a result, the lock release member 223 comes into contact with the lock portion 413 and pushes it back toward the inner cavity 52. As a result, the engagement of the engagement portion 413 is released, and the plunger 41 moves in the distal direction by the elastic force of the compressed coil spring 42, the needle 141 projects from the distal opening 162, and punctures the surface of the fingertip 200. (See FIG. 8). Needle 1
Bleeding occurs from the puncture site 210 due to 41.

When the operation button 222 is pressed, the operation switch (not shown) of the pump 8 is turned on almost simultaneously.

[5] After the needle 141 pierces the fingertip 200, the coil spring 43 pushes the plunger 41 back in the proximal direction. The plunger 41 stops at a position where the elastic force of the coil spring 42 and the elastic force of the coil spring 43 balance through the damping movement (see FIGS. 5 and 9). At this time, the needle 1
The cutting edge 41 is housed in the tip 13. As described above, the cutting edge of the needle body 141 has the tip opening 16 except at the time of puncturing.
2 so that it does not protrude, it does not injure the skin etc. accidentally, and it can also prevent infection,
High safety.

[6] When the operation switch of the pump 8 is turned on, the control means operates the pump 8 (FIG. 14).
Step S102).

That is, almost simultaneously with the operation [4], the pump 8 operates, and the suction of the air in the lumen 52 of the housing 5 is started. As a result, the pressure of the lumen 52 (including the inside of the chip 13) is reduced, and the pressure is reduced.

At this time, the puncture site 210 of the fingertip 200 with the needle 141 is also in a reduced pressure state. However, in this state, the fingertip 200 located inside the contact portion 163 (tip opening 162) rises toward the inside of the chip 13 like a hill, and the puncture site 210 where the tip of the contact portion 163 is in contact. The capillaries are squeezed in the surrounding area.

[7] Further, the lumen 5 by the pump 8
When the suction of 2 is continued, the air in the variable volume chamber 631
Through the orifice 651, the gas gradually flows into the lumen 52, and the volume of the variable volume 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 200
It gradually starts moving in the direction away from.

At this time, since the depressurized state of the lumen 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. 10). 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 almost simultaneously by one pressing of the operation button 222, and the retracting operation of the tip 13 is performed by the depressurizing force of the pump 8. Is carried out using
Since the decompression releasing operation described later is also started automatically, the operability is extremely good.

[8] By the operation of the above [7], 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 lancet dextrose amount Color changes according to

On the other hand, after executing the step S102 shown in FIG. 14, 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 S103 in FIG. 14).

In step S103, 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.

Note that 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 S103 that no blood has been collected, it is determined whether or not the time is up (step S104 in FIG. 14).

In step S104, if it is determined that the time is not up, the process returns to step S102, and steps S102 and subsequent steps are executed again. If it is determined that the time is up, an error process is performed (FIG. 14). Step S105).

In step S105, the pump 8 is stopped, the solenoid valve 26 is opened to release the reduced pressure state, and a display indicating an error (error display) is displayed on the display unit 12.

The operator (user) can recognize from the error display that the error is an error (there is a problem). The operation when the electromagnetic valve 26 is opened will be described later in detail.

When it is determined in step S103 that blood has been collected, the pump 8 is stopped (step S106 in FIG. 14).

Next, the solenoid valve 26 is opened to release the reduced pressure state (step S107 in FIG. 14).

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. 11).

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. 11 and 12). At this time, the tip of the flange 56 of the housing 5 is
, And further movement in the distal direction is restricted (see FIG. 12).

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.

[9] After executing the step S107 shown in FIG. 14, 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 S108 in FIG. 14).

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 has been released. ) 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 S109 in FIG. 14). Thereby, the blood sugar level can be grasped.

As described above, this component measuring device 1
According to the above, the chip 13 is connected to the housing 5 of the
When the tip 13 is not properly attached or when the used tip 13 is attached to the housing 5, the puncture needle 1 of the tip 13
Since the needle point of the fourth needle body 141 does not protrude from the front end (the front end opening 162) of the contact portion 163, it is safe.

In addition, in a short time, a sufficient amount of blood necessary and sufficient for measurement can be collected, and a blood sugar level (amount of a predetermined component in blood) can be accurately and reliably measured. .

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 continuously performed.
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 when the device 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.

Although the component measuring device chip, the component measuring device, and the component measuring system of the present invention have been described based on the illustrated embodiment, the present invention is not limited to this. The configuration can be replaced with any configuration that can exhibit the same function.

[0205] In the above-described embodiment, blood is representatively described as a bodily fluid to be collected. However, in the present invention, the bodily fluid to be collected is not limited to this, and may be, for example, sweat, lymph, cerebrospinal fluid, or the like. 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, but 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 above-described embodiment, the means for both 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.

Further, in the above-described embodiment, a means for optically detecting blood collection is used as the blood collection detecting means. However, the present invention is not limited to this.
Means for electrically detecting may be used.

Further, the component measuring device and the component measuring system of the present invention optically measure (colorimetrically measure) the color intensity of the test paper colored by the reaction between the components in blood and the reagent as described above. The present invention is not limited to the method of converting to a measured value and displaying the measured value. For example, it is also possible to electrically measure a potential change corresponding to the amount of a component in a sample, convert the measured value to a measured value, and display the measured value.

In the above 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 decompression means and the tip retreat mechanism may be started manually or automatically, respectively. In the latter case, a sensor or the like configured to magnetically sense the movement of the puncture needle in the tip direction at the time of puncturing the fingertip is installed near the side position of the fitting portion of the housing, and information of this sensor is provided. , The pressure reducing means and the chip retracting mechanism can be operated. Further, in the present invention, the chip retracting mechanism may be omitted.

[0213]

As described above, according to the present invention, when the component measuring device chip is not properly mounted on the component measuring device, or when the used component measuring device chip is mounted on the component measuring device, In addition, since the tip of the puncture needle of the component measuring device tip does not protrude from the tip of the contact portion, it is safe.

In addition, it is possible to reliably measure a predetermined component in a body fluid (eg, blood) in a short time.

When a test paper is provided on the component measuring device chip, puncturing, collection of a body fluid (eg, blood), development on the test paper, and measurement (quantification of components) are continuously performed. And the 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.

In addition, 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 is suitable for mass production.

[Brief description of the drawings]

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

FIG. 2 is a longitudinal sectional view showing an embodiment of a chip for a component measuring device of the present invention.

FIG. 3 is a longitudinal sectional view showing an example of a configuration of a puncturing means and a housing containing a puncturing means of the component measuring device shown in FIG. 1 and a chip for the component measuring device shown in FIG. State before mounting).

4 is a longitudinal sectional view showing an example of a configuration of a puncturing means and a housing containing a puncturing means included in the component measuring device shown in FIG. 1 and a chip for the component measuring device shown in FIG. Attached state).

5 is a longitudinal sectional view (stable state after puncturing) showing a configuration example of a puncturing means and a housing containing a puncturing means included in the component measuring device shown in FIG. 1 and a chip for the component measuring device shown in FIG. 2; .

6 is a longitudinal sectional view showing an example of a configuration of a puncturing means and a housing containing a puncturing means included in the component measuring device shown in FIG. 1 and a chip for the component measuring device shown in FIG. 2 (used component measuring device chip); Is mounted on the housing).

FIG. 7 is a longitudinal sectional view showing a configuration example of a main part in the component measuring device shown in FIG. 1 (a state before the puncturing means is operated).

FIG. 8 is a longitudinal sectional view showing a configuration example of a main part in the component measuring device shown in FIG. 1 (when the puncturing means is operated).

9 is a longitudinal sectional view showing a configuration example of a main part of the component measuring device shown in FIG. 1 (when the pressure reducing means is operated).

10 is a longitudinal sectional view showing a configuration example of a main part in the component measuring device shown in FIG. 1 (when the tip retracting mechanism operates).
It is.

11 is a vertical cross-sectional view showing a configuration example of a main part of the component measuring device shown in FIG. 1 (when the decompression releasing means is operated).

12 is a longitudinal sectional view (final state) showing a configuration example of a main part in the component measuring device shown in FIG. 1.

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

FIG. 14 is a flowchart showing a control operation (including a part of the operation of the operator) of the control means of the component measuring device shown in FIG. 1;

[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 Lancet 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 part 631 Variable volume chamber 64 Seal ring 65 Small tube 651 Orifice 7 Measuring means 71 Light emitting element 72 Light receiving element 8 Pump 81, 82 Tube 9 Battery 10 Circuit board 11 Control means 12 Display part 13 Component measurement Constant device tip 130 Tip main body 14 Puncture needle 141 Needle body 142 Lancet 143 Reduced diameter portion 15 First housing 151 Inner peripheral surface 152 Inner cavity 153 Wall 154 Hole 155 Convex 16 Second housing 161 Inner cavity 162 Tip opening 163 Contact part 164 Flange 165 Depression 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 Electromagnetic valve 200 Fingertip 210 Puncture site 220 Blood S101 ~ S109 Step

Claims (8)

[Claims] Claims: 1. A component measuring device chip used by being attached to a component measuring device for measuring a component of a bodily fluid collected by puncturing the epidermis with a puncture needle, the tip being provided at an inner cavity portion and at a tip, A tip body having a contact portion with which the epidermis abuts, and a puncture needle movably provided in the lumen of the tip body and puncturing the epidermis, for the component measuring device to the component measuring device When attempting to mount the tip, if the component measuring device tip is not properly mounted, and / or if the component measuring device tip has been used, the puncture needle of the component measuring device tip A tip for a component measuring device, wherein a tip of the needle does not protrude from the contact portion. 2. A chip for a component measuring device which is used by being attached to a component measuring device for measuring a component of a bodily fluid collected by puncturing the epidermis with a puncturing needle by an urging means, and having the puncturing needle, A tip body having a cavity and a contact portion provided at the tip and having an abutment with an epidermis; provided movably within the lumen of the tip body to support the puncture needle and for the component measuring device A lancet provided with a fitting portion that fits into the urging means of the component measuring device or the plunger urged by the urging means when the chip is mounted on the component measuring device; When the component measuring device chip is properly mounted on the component measuring device, the fitting distance of the fitting portion is L1, and the urging means after the puncture needle punctures the epidermis. The contact portion in a stable state Wherein the distance from the tip of the tip to the tip of the puncture needle of the component measuring device tip is L2, the relationship L1 <L2 is satisfied. 3. The tip body is provided with an introduction guide for receiving a bodily fluid, and when a distance from a tip of the contact portion to a tip of the introduction guide is L3, a relationship of L2−L1> L3 is satisfied. The chip for a component measuring device according to claim 2, wherein the chip is configured to satisfy the following. 4. A tip body having a lumen portion, a tip portion provided at a distal end thereof, and an abutting portion with which an epidermis contacts, a lancet movably provided in the lumen portion of the tip body and supporting a puncture needle. A component measuring device for measuring a component of a bodily fluid collected by puncturing the epidermis with the puncture needle, using the component measuring device chip provided with When attempting to mount the tip, if the component measuring device tip is not properly mounted, and / or if the component measuring device tip has been used, the puncture needle of the component measuring device tip A component measuring device, wherein a needle tip does not protrude from the contact portion. 5. A tip body having a lumen portion, a tip portion provided at a distal end thereof, and a contact portion with which an epidermis contacts, a lancet movably provided in the lumen portion of the tip body and supporting a puncture needle. A component measurement device for measuring a component of a bodily fluid collected by puncturing the epidermis with the puncture needle, wherein the component measurement device is equipped with a chip for a component measurement device provided with: a plunger; and the plunger. And a lancet of the component measuring device tip is fitted to the biasing device or the plunger when the component measuring device tip is mounted on the component measuring device. It has a fitting portion, and when the unused component measuring device chip is properly mounted on the component measuring device, the fitting distance of the fitting portion is L1, and the puncture needle is The biasing hand after puncturing Wherein the distance from the tip of the contact portion to the tip of the puncture needle of the component measuring device tip in the stable state is L2, and the relationship L1 <L2 is satisfied. measuring device. 6. A tip body having an inner cavity portion and a contact portion provided at a distal end and contacting an epidermis, and a lancet movably provided in the inner cavity portion of the tip body and supporting a puncture needle. A component measuring system comprising: a component measuring device chip having the component measuring device chip; and a component measuring device for measuring a component of a bodily fluid collected by puncturing the epidermis with the puncture needle, using the component measuring device chip. When attempting to mount the component measuring device chip on the component measuring device, when the component measuring device chip is not properly mounted, and / or when the component measuring device chip has been used. In this case, the component measuring system is characterized in that the tip of the puncture needle of the component measuring device tip does not protrude from the contact portion. 7. A component measuring device for measuring a component of a bodily fluid collected by puncturing the epidermis with a puncture needle by an urging means, and a component measuring device attached to the component measuring device and having the puncture needle. A component measuring system including a tip, wherein the component measuring device has a plunger biased by the biasing means, the component measuring device tip is provided at an inner cavity and a tip, A tip body having an abutment portion with which the epidermis abuts, and movably provided in the lumen of the tip body, supporting the puncture needle, and mounting the component measurement device tip to the component measurement device. A lancet provided with a fitting portion to be fitted to the plunger, when the unused component measuring device chip is properly mounted on the component measuring device, and Mating distance L1 and the distance from the tip of the contact portion to the needle tip of the puncture needle of the component measuring device tip in the stable state of the urging means after the puncture needle pierces the epidermis is L2, A component measurement system configured to satisfy a relationship of L1 <L2. 8. An introduction guide for receiving a bodily fluid is provided on the tip body of the component measuring device tip, wherein a distance from a tip of the contact portion to a tip of the introduction guide is L3. The component measurement system according to claim 7, wherein the component measurement system is configured to satisfy a relationship of L2-L1> L3.