CN101095614A - Body fluid composition measuring apparatus - Google Patents

Abstract

A body fluid component measuring apparatus capable of accurately measuring a specific component in a body fluid for a short time is provided. The apparatus includes, in a main body, a measuring means 7 for detecting the sampling of a body fluid and measuring a component of the sampled body fluid, and a pump and an electromagnetic valve which constitute an evacuating mechanism. When the sampling of blood is detected, the pump is stopped to release the evacuation state. Another apparatus according to a second aspect includes a pressure detecting means and a notifying means. A puncturing means 4 is operated only when it is decided, on the basis of a result of detection by a sensor, that the housing is in an evacuation state, and after the sampling is detected, the evacuation is released and information is notified. A further apparatus according to a third aspect includes a pressure adjusting means for fluctuating the pressure.

Description

Body fluid component measuring device

This application is a divisional application, and the application number of the parent application is 01816352.1, the application date of the parent application is 7/26/2001, and the invention name of the parent application is a body fluid component measuring device.

Technical Field

The present invention relates to a body fluid component measuring device, and more particularly to a body fluid component measuring device that punctures the epidermis with a puncture needle at the time of blood detection, collects blood, and measures the amount of a specific component such as glucose in the blood.

Background

In recent years, with the increase in diabetic patients, a self-blood glucose level measurement method is recommended in which the patients monitordaily blood glucose level fluctuations by themselves.

In such a blood glucose level measurement, a blood glucose measuring apparatus is used, in which a test strip developing color in accordance with the amount of glucose in blood is attached, blood is supplied to the test strip, the test strip is scattered and developed, and the degree of the development is optically measured (color measurement) to quantify the blood glucose level.

As a method for collecting blood by the patient himself/herself before measurement, the skin of the epidermis is punctured with a puncturing mechanism having a puncturing needle or a knife, and then the periphery of the punctured portion is pressed with a finger or the like to express blood.

The fingertips are suitable for collecting blood because of the concentration of capillaries, but are also suitable for collecting blood because of the concentration of nerves, and cause pain, a large pain and burden on patients, and fear due to puncture, so that many patients cannot measure blood sugar continuously.

In addition, in the conventional blood glucose measurement, since the puncturing operation, the blood sampling operation, and the measurement operation are performed separately, the operability is also poor.

As a device for solving the above-mentioned problems, there is known a blood glucose measuring device in which a puncturing means and a measuring device are integrated and a suction means for extruding blood is provided (Japanese patent application No. 10-183794 and Japanese patent application No. 10-330057).

With this blood glucose measuring device, first, the tip of the finger is pressed against the tip of the puncture instrument, and the tip opening is hermetically sealed.

Then, after the fingertip is punctured with the puncture needle projecting from the distal end opening, the suction mechanism is driven in this state (in a depressurized state), and blood is aspirated from the puncture site to collect the blood. Then, the blood glucose level of the collected blood is measured by the measuring apparatus.

However, since blood is sucked under a constant pressure by this blood glucose measuring apparatus, it takes a relatively long time to obtain the amount of blood necessary for measuring the blood glucose level.

Further, since the finger is spaced from the distal end of the puncture device by the position of the finger pressed against the finger, and the pressure cannot be sufficiently reduced even when the suction mechanism is driven, the amount of blood required for measuring the blood glucose level cannot be obtained, and it takes a relatively long time to obtain a sufficient amount of blood.

The following shows the glucose in blood when the blood glucose level is measured (_DGlucose) and a reagent, and it can be judged from the following chemical reaction formula that a sufficient amount of oxygen is required for the measurement of the blood Glucose level, and if the amount of oxygen is insufficient, an accurate blood Glucose level cannot be obtained.

However, the conventional blood glucose measuring apparatus measures the blood glucose level in the original state under reduced pressure, and in this case, theoxygen is insufficient, so that an accurate blood glucose level may not be obtained.

Therefore, the present inventors have proposed a method of supplying oxygen (a component in the atmosphere necessary for measurement) sufficiently in a reduced pressure state before measurement by releasing or relaxing the reduced pressure state, and have completed the present invention.

The purpose of the present invention is to provide a body fluid component measurement device capable of accurately and reliably measuring a predetermined component in blood in a short time.

Disclosure of Invention

The above object is achieved by the following first aspects (1) to (10) of the present invention.

(1) A body fluid component measuring device to be used after attaching a puncture instrument having a puncture needle and a test paper,

the puncture device having the puncture needle and the test paper further includes a case, the test paper being disposed on an outer peripheral portion of the case, the case having a contact portion at a distal end thereof, the contact portion being in contact with a skin of a puncture site, and an opening at an inner side of the case;

the body fluid component measuring device includes:

a stopper portion against which the punctured epidermis is made to abut;

a housing space for holding the puncture instrument;

a puncture mechanism for driving the puncture needle to puncture the epidermis attached to the stopper;

a decompression mechanism for bringing the skin puncture site of the puncture needle into a decompressedstate together with the accommodation space of the puncture device;

a measuring mechanism for measuring the amount of a predetermined component in the body fluid collected from the puncture site and scattered on the test strip;

a body fluid collection detection mechanism for detecting collection of the body fluid; and

a decompression release mechanism for releasing or relaxing at least the decompression state of the accommodating space of the test strip,

and adopts the following constitution: when the collection of the body fluid is detected by the body fluid collection/detection means, the reduced pressure state of at least the housing space of the test strip is released or relaxed by the reduced pressure release means, and thereafter the amount of a predetermined component in the collected body fluid is measured by the measurement device.

(2) The body fluid component measurement device according to item (1) above, wherein the measurement requires a predetermined component in the atmosphere.

(3) The body fluid component measuring device according to the above (1) or (2), wherein the decompression cancellation mechanism includes a flow path for communicating the storage space with the outside, and a valve for opening and closing the flow path.

(4) The body fluid component measuring device according to the above (1) or (2), wherein the decompression cancellation mechanism has a flow path for communicating the storage space with the outside, and at least a part of the flow path has a portion having relatively large resistance to passage of air.

(5) The body fluid component measuring device according to any one of the above (1) to (4), wherein at least a part of the measuring means and at least a part of the body fluid collecting and detecting means are shared with each other.

(6) The body fluid component measuring device according to any one of the above (1) to (5), wherein the body fluid component measuring device has a housing which holds the puncture instrument and incorporates the puncture mechanism,

the decompression mechanism brings the accommodation space in the housing into a decompressed state.

(7) The body fluid component measuring device according to item (6) above, wherein the decompression release mechanism releases or relaxes the decompression state of the storage space in the case.

(8) The body fluid component measuring device according to any one of the above (1) to (7), wherein the driving of the puncture mechanism and the driving of the pressure reducing mechanism are started substantially simultaneously.

In the present application, the invention of the first aspect also provides an invention (9) of an aspect including a pressure detection mechanism and a notification mechanism defined in (12) of the second aspect described later, or an invention (10) of an aspect including a pressure adjustment mechanism defined in (25) of the third aspect, both of which are aspects of the apparatus.

(9) The body fluid component measuring device according to any one of the above (1) to (8), further comprising: a pressure detection means for detecting a pressure in the accommodation space; and a notification means for notifying predetermined information, wherein the pressure reduction means tries to reduce the pressure in the storage space, and the notification means notifies the pressure detection means based on information from the pressure detection means.

The puncture device has a stopper portion against which the punctured epidermis is brought into contact.

(10) The body fluid component measuring device according to any one of the above (1) to (9), further comprising a pressure adjusting mechanism for adjusting a pressure in the accommodating space of the puncture needle.

The above object is achieved by (11) to (21) of a second aspect of the present invention described below.

(11) A body fluid component measuring device for collecting body fluid through the epidermis and measuring the components of the body fluid, comprising:

a stopper portion against which the punctured epidermis is made to abut;

a space hermetically sealed by abutting a skin against the stopper;

a decompression mechanism for making the space in a decompressed state;

a measuring means for measuring the amount and/or the property of a predetermined component in the body fluid collected in the space;

a pressure detection means for detecting the pressure in the space; and

a notification mechanism for notifying given information,

and adopts the following constitution: the pressure reducing means reduces the pressure of the space in a test, and the notifying means notifies the space based on information from the pressure detecting means.

(12) A body fluid component measuring device to be used after a puncture instrument having a puncture needle is attached, comprising:

a stopper portion against which the punctured epidermis is made to abut;

a puncture mechanism for driving the puncture needle to puncture the epidermis attached to the stopper;

a decompression mechanism for bringing the skin puncture site of the puncture needle and the accommodation space of the puncture needle into a decompressed state at the same time;

a pressure detecting means for detecting a pressure in the accommodating space;

a measuring means for measuring the amount of a predetermined component in the body fluid collected from the puncture site; and

a notification mechanism for notifying given information,

and adopts the following constitution: the pressure reduction mechanism is configured to reduce the pressure in the storage space in a test, and the notification mechanism is configured to notify the storage space based on information from the pressure detection mechanism.

(13) A body fluid component measuring device to be used after a puncture instrument having a puncture needle is attached, comprising:

a stopper portion against which the punctured epidermis is made to abut;

a puncture mechanism for driving the puncture needle to puncture the epidermis attached to the stopper;

a decompression mechanism for bringing the skin puncture site of the puncture needle and the accommodation space of the puncture needle into a decompressed state at the same time;

a pressure detecting means for detecting a pressure in the accommodating space;

a measuring means for measuring the amount of a predetermined component in the body fluid collected from the puncture site; and

a notification mechanism for notifying given information,

and adopts the following constitution: the pressure reduction mechanism tries to reduce the pressure in the storage space, and the notification mechanism notifies that there is an error when the pressure detection mechanism does not detect the reduced pressure state in the storage space.

(14) A body fluid component measuring device to be used after a puncture instrument having a puncture needle is attached, comprising:

a stopper portion against which the punctured epidermis is made to abut;

a puncture mechanism for driving the puncture needle to puncture the epidermis attached to the stopper;

a decompression mechanism for bringing the skin puncture site of the puncture needle and the accommodation space of the puncture needle into a decompressed state at the same time;

a pressure detecting means for detecting a pressure in the accommodating space;

a measuring means for measuring the amount of a predetermined component in the body fluid collected from the puncture site; and

a notification mechanism for notifying given information,

and adopts the following constitution: the pressure reducing means is adapted to reduce the pressure of the storage space in an attempt, and the notifying means is adapted to notify that the skin position abutting the stopper is to be corrected when the pressure detecting means does not detect the reduced pressure state of the storage space, and to notify the notifying means that an error has occurred when the pressure detecting means does not detect the reduced pressure state of the storage space even after a lapse of a predetermined time.

(15) The body fluid component measuring device according to any one of (12) to (14) above, wherein the puncture needle is driven by the puncture mechanism when the pressure detection mechanism detects a reduced pressure state inthe storage space.

(16) A body fluid component measuring device to be used after a puncture instrument having a puncture needle is attached, comprising:

a stopper portion against which the punctured epidermis is made to abut;

a puncture mechanism for driving the puncture needle to puncture the epidermis attached to the stopper;

a decompression mechanism for bringing the skin puncture site of the puncture needle and the accommodation space of the puncture needle into a decompressed state at the same time;

a pressure detecting means for detecting a pressure in the accommodating space; and

a measuring means for measuring the amount of a predetermined component in the body fluid collected from the puncture site,

and adopts the following constitution: the pressure reduction mechanism is configured to reduce the pressure in the storage space by an attempt, and the puncture needle is driven by the puncture mechanism when the pressure detection mechanism detects a reduced pressure state in the storage space.

(17) The body fluid component measuring device according to the above (15) or (16), further comprising a drive start mechanism having a drive source electrically driven, and starting the driving of the puncture mechanism by the driving of the drive source,

when the pressure detection means detects a reduced pressure state in the storage space, the drive start means starts driving the puncture needle, and the puncture needle is driven by the puncture mechanism.

(18) The body fluid component measuring device according to any one of the above (12) to (16), wherein the puncture mechanism includes a plunger and a biasing member for biasing the plunger in a distal direction.

(19) The body fluid component measuring device according to the above (18), wherein the plunger has an engaging portion for restricting movement in the distal direction, and in a state where the plunger is biased by the biasing member, the engagement of the engaging portion is released, and the plunger is moved in the distal direction to puncture the puncture needle.

(20) The body fluid component measuring device according to item (19) above, further comprising a drive starting mechanism having a drive source electrically driven and releasing the engagement of the engagement portion by the driving of the drive source,

when the pressure detection means detects a reduced pressure state of the storage space, the drive start means releases the engagement of the engagement portion.

(21) The body fluid component measuring device according to any one of the above (12) to (20), wherein when the pressure detecting means detects the reduced pressure state of the storage space, the reduced pressure state is once released, and thereafter the puncture is performed, and the finger puncture site of the puncture needle and the storage space of the puncture needle are simultaneously brought into a reduced pressure state by the pressure reducing means.

(22) The body fluid component measuring device according to any one of the above (12) to (21), wherein the body fluid component measuring device has a housing that holds the puncture instrument and incorporates the puncture mechanism,

the decompression mechanism brings the accommodation space in the housing into a decompressed state.

(23) The body fluid component measuring device according to the above (22), wherein the pressure detecting means detects the pressure in the housingspace in the case.

The above object is also achieved by (24) to (32) of the third aspect of the present invention described below.

(24) A body fluid component measuring device for collecting body fluid through the epidermis and measuring the components of the body fluid, comprising:

a stopper portion against which the punctured epidermis is made to abut;

a space hermetically sealed by abutting a skin against the stopper;

a pressure adjusting mechanism for adjusting the space pressure; and

a measuring means for measuring the amount and/or the property of a given component in the body fluid collected in the space,

and adopts the following constitution: when collecting body fluid through the epidermis in the space, the pressure of the space is reduced by the pressure adjustment mechanism, and the pressure is varied with time.

(25) A body fluid component measuring device to be used after a puncture instrument having a puncture needle is attached, comprising:

a stopper portion against which the punctured epidermis is made to abut;

a puncture mechanism for driving the puncture needle to puncture the epidermis attached to the stopper;

a pressure adjusting mechanism for adjusting the pressure in the accommodating space of the puncture needle; and

a measuring means for measuring the amount of a predetermined component in the body fluid collected from the puncture site,

and adopts the following constitution: when the body fluid is collected from the puncture site, the pressure in the storage space is reduced by the pressure adjustment mechanism, and the pressure is varied with time.

(26) The body fluid component measuring device according to item (25) above, further comprising: the pressure control device is provided with a pressure detection means for detecting the pressure in the storage space, and the pressure in the storage space is adjusted by the pressure adjustment means based on information from the pressure detection means.

(27) The body fluid component measuring device according to the above (25) or (26), wherein the pressure regulating means alternately switches the pressure in the storage space between a first pressure lower than the atmospheric pressure and a second pressure higher than the first pressure when the body fluid is collected.

(28) The body fluid component measuring device according to (27) above, wherein the second pressure is at atmospheric pressure or below.

(29) The body fluid component measuring device according to the above (27) or (28), wherein a difference between the second pressure and the first pressure is 100 to 600 mmHg.

(30) The body fluid component measuring device according to any one of (27) to (29), wherein the cycle of the pressure fluctuation is 1 to 30 sec.

(31) The body fluid component measuring device according to the above (25) or (26), wherein, when the body fluid is collected, the pressure in the storage space is once changed to a first pressure lower than the atmospheric pressure by the pressure adjusting means at least once, and thereafter, the pressure is gradually increased.

(32) The body fluid component measuring device according to any one of (27) to (31), wherein the first pressure is 100 to 600 mmHg.

In the first to third aspects described above,

(33) the body fluid component measuring device according to any one of the above (1) - (8), (14) - (23), and (25) - (32), wherein the puncture device has a stopper portion for abutting a punctured epidermis.

(34) The body fluid component measuring device according to any one of the above (1) - (8), (14) - (23), and (25) - (33), wherein the puncture device comprises a test strip and a blood path for supplying blood to the test strip.

(35) The body fluid component measuring device according to the above (34), wherein the test strip is a test strip for measuring blood glucose.

Brief description of the drawings

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

Fig. 2 is a longitudinal sectional view showing an example of the configuration of the puncture instrument used in the present invention.

Fig. 3 is a vertical cross-sectional view showing an example of the configuration of the puncture mechanism and the housing incorporating the puncture mechanism of the body fluid component measurement device according to the first embodiment (a state before the puncture device is mounted in the housing).

Fig. 4 is a vertical cross-sectional view showing an example of the configuration of the puncture mechanism and the housing incorporating the puncture mechanism of the body fluid component measurement device according to the first embodiment (a state in which the puncture device is mounted in the housing).

FIG. 5 is a vertical cross-sectional view showing an example of the configuration of the main part of the body fluid component measuring apparatus according to the first embodiment (a state before the puncture mechanism is driven).

FIG. 6 is a vertical cross-sectional view showing an example of the configuration of the main part of the body fluid component measuring apparatus according to the first embodiment (the state when the puncture mechanism is driven).

FIG. 7 is a vertical cross-sectional view showing an example of the configuration of the main part of the body fluid component measuring apparatus according to the first embodiment (a state when the pressure reducing mechanism is driven).

FIG. 8 is a vertical cross-sectional view showing an example of the configuration of the main part of the body fluid component measuring apparatus according to the first embodiment (a state when the puncture device retracting mechanism is driven).

FIG. 9 is a vertical cross-sectional view showing an example of the configuration of the main part of the body fluid component measuring apparatus according to the first embodiment (a state when the decompression release mechanism is driven).

FIG. 10 is a vertical cross-sectional view (final state) showing an example of the configuration of the main part of the body fluid component measuring device according to the first embodiment.

FIG. 11 is a block diagram showing a circuit configuration of the body fluid component measuring apparatus according to the first embodiment.

Fig. 12 is a block diagram showing a procedure of a control operation (including a part of the operation, an operator's operation, and the like) of the control means of the body fluid component measurement device according to the first embodiment.

FIG. 13 is a longitudinal sectional view showing a main part of a body fluid componentmeasuring device according to a second embodiment of the present invention.

FIG. 14 is a block diagram showing a circuit configuration of a body fluid component measuring apparatus according to a second embodiment.

Fig. 15 is a vertical cross-sectional view showing an example of a puncture mechanism provided in a body fluid component measuring apparatus according to a second embodiment of the present invention and a configuration of a case having the puncture mechanism built therein (a state before the puncture instrument is mounted in the case).

Fig. 16 is a vertical sectional view showing an example of a puncture mechanism and a housing structure incorporating the puncture mechanism of a body fluid component measurement device according to a second embodiment of the present invention (a state in which the puncture instrument is mounted in the housing).

FIG. 17 is a vertical sectional view (a state when the pressure reducing mechanism is driven) showing an example of the configuration of a main part of the body fluid component measuring apparatus according to the first embodiment of the second aspect of the present invention.

FIG. 18 is a vertical sectional view showing an example of the configuration of the main part of the body fluid component measuring device according to the second embodiment of the present invention (the state when the puncture mechanism is driven).

FIG. 19 is a block diagram showing a circuit configuration of a body fluid component measuring apparatus according to a second embodiment of the present invention.

FIG. 20 is a block diagram showing a procedure of a control operation of a control means of the body fluid component measuring device according to the second embodiment of the present invention.

Fig. 21 is a block diagram showing a control operation of the control means according to the second embodiment of the present invention.

Fig. 22 is a block diagram showing a control operation of the control means according to the third embodiment of the present invention.

Fig. 23 is a graph showing a pressure pattern in the accommodating space (the lumen portion 52) of the puncture needle at the time of blood collection according to the second embodiment of the present invention.

Fig. 24 is a graph showing a pressure pattern in the accommodating space (the cavity portion 52) of the puncture needle at the time of blood collection according to the second embodiment of the present invention.

FIG. 25 is a perspective view schematically showing a first embodiment of a body fluid component measuring device according to a third embodiment of the present invention.

Fig. 26 is a vertical sectional view showing an example of a puncture mechanism provided in a body fluid component measuring apparatus according to a third embodiment of the present invention and a configuration of a case having the puncture mechanism built therein (a state before the puncture device is mounted in the case).

Fig. 27 is a vertical sectional view showing an example of a puncture mechanism and a housing structure incorporating the puncture mechanism of a body fluid component measurement device according to a third embodiment of the present invention (a state in which a puncture instrument is mounted in a housing).

FIG. 28 is a vertical sectional view showing an example of the configuration of the main part of the body fluid component measuring apparatus according to the third embodiment of the present invention (the state before driving of the pressure adjusting mechanism and the puncturing mechanism).

FIG. 29 is a vertical sectional view (state when the puncture mechanism is driven) showing an example of the configuration of the main part of the body fluid component measuring device according to the third embodiment of the present invention.

FIG. 30 is a vertical sectional view showing an example of the configuration of the main part of the body fluid component measuring device according to the third embodiment of the present invention (the state after puncturing and when the pressure adjusting mechanism is operated).

FIG. 31 is a vertical cross-sectional view (final state) showing an example of the configuration of the main part of the body fluid component measuring device according to the third embodiment of the present invention.

FIG. 32 is a block diagram showing a control operation of a control means of the body fluid component measuring device according to the third embodiment of the present invention.

FIG. 33 is a graph showing a pressure pattern in the accommodating space (cavity portion 52) of the puncture needle when blood is collected by the body fluid component measuring device according to the third embodiment of the present invention.

FIG. 34 is a longitudinal sectional view showing a main part of a body fluid component measuring device according to a third embodiment of the present invention.

FIG. 35 is a graph showing a pressure pattern in the accommodating space (cavity portion 52) of the puncture needle when blood is collected by the body fluid component measuring apparatus according to the third embodiment of the present invention.

Bestmode for carrying out the invention

The body fluid component measuring device of the present invention is a device for collecting body fluid through the epidermis (skin) and measuring a predetermined component of the body fluid.

The part of the epidermis involved in the collection of the body fluid (puncture part in the present embodiment) is preferably a finger, but other parts such as the back of the hand, palm of the hand, side of the hand, wrist, thigh, etc. are also possible.

Hereinafter, a body fluid component measuring apparatus (blood glucose measuring apparatus) in the form of puncturing the skin of a fingertip (finger) when a body fluid is blood will be described as a representative example.

Hereinafter, the body fluid component measuring device according to the present invention will be described in detail with reference to preferred embodiments shown in the drawings.

Fig. 1 is a perspective view schematically showing a first embodiment of a body fluid component measuring device according to a first embodiment of the present invention, fig. 2 is a vertical cross-sectional view showing an example of a configuration of a puncture instrument used in the present invention, fig. 3 and 4 are vertical cross-sectional views showing an example of a configuration of a puncture mechanism and a housing having the puncture mechanism incorporated therein, which are provided in the body fluid component measuring device according to the first embodiment, fig. 5 to 10 are vertical cross-sectional views showing an example of a configuration of a main portion of the body fluid component measuring device according to the first embodiment, fig. 11 is a block diagram showing a circuit configuration of the body fluid component measuring device according to the first embodiment, and fig. 12 is a program block diagram showing a control operation (including a part, an operation of an operator, and the like) of a control mechanism of the body fluid component measuring device according to the first embodiment. In fig. 1 to 10, the right side of the paper surface is referred to as the "base end" and the left side is referred to as the "tip end".

As shown in fig. 1, 5, and 11, a body fluid component measurement device (blood component measurement device) 1 according to a first embodiment includes: a body 2; a stopper portion 3 provided on the body 2; a puncture mechanism 4 housed in the housing 5; a puncture instrument retracting mechanism 6 provided on the proximal end side of the housing 5; a measuring means 7 for detecting collection of blood and measuring a predetermined component in the collected blood; a pump 8 for reducing the pressure inside the casing 5; a solenoid valve 26 for releasing, relaxing, or maintaining the pressure-reduced state in the case 5; a battery (power supply) 9; a control mechanism 11 and a display portion 12 provided on the printed circuit board 10.

The body fluid component measurement device 1 is used with the puncture instrument 13 attached thereto, and requires a predetermined component (for example, oxygen, carbon dioxide, water vapor, or the like) in the atmosphere in a chemical reaction when measuring a predetermined component in blood. The following describes each constituent element.

The main body 2 is composed of a frame 21 and a lid 22 facing each other. The main body 2 has a housing space 23 formed therein, and the puncture mechanism 4, the housing 5, the puncture instrument retracting mechanism 6, the measuring mechanism 7, the pump 8, the electromagnetic valve 26, the battery 9, the printed circuit board 10, the control mechanism 11, and the display unit 12 are mounted in the housing space 23.

An opening 212 having a circular cross-sectional shapeis formed through the inside and outside of the frame 21 in the wall portion 211 on the front end side of the frame 21. The puncture instrument 13 described later is attached (held) to the housing 5 through the opening 212.

Further, a stopper portion 3 formed corresponding to the shape of a fingertip (finger) is provided on the surface of the wall portion 211 on the front end side, around the outer periphery of the opening 212. A finger stopper surface 31 is formed on the front end side of the stopper portion 3. The body fluid component measuring apparatus 1 is driven while the fingertip is brought into contact with the stopper portion 3 (finger stopper surface 31).

With this, the epidermis of the finger is punctured, and the amount of a predetermined component (hereinafter, in the present embodiment, glucose is described as a representative) in the collected blood is measured.

With this blood glucose measuring device, first, the tip of the finger is pressed against the tip of the puncture instrument, and the tip opening 212 is sealed to maintain airtightness.

Next, after the fingertip is punctured with the puncture needle projecting from the distal end opening 212, the suction mechanism is driven (brought into a depressurized state) in this state, blood is aspirated from the puncture site, the blood is collected, and then the blood glucose level of the collected blood is measured with the measurement device.

A display window (opening) 221 is formed on the upper surface of the cover 22 so as to penetrate the inside and outside of the cover 22, and the display window is covered with a plate-like member made of a transparent material.

The display unit 12 is provided at a position in the housing space 23 corresponding to the display window 221. Therefore, various information displayed by the display unit 12 can be confirmed through the display window 221.

The display unit 12 is formed of, for example, a liquid crystal display element (LCD). The display unit 12 can display, for example, on/off of a power supply, a power supply voltage (remaining battery level), a measurement value, a measurement date, an error display, an operation guide, and the like.

Further, an operation button 222 is provided on the upper surface of the cover 22. The body fluid component measuring apparatus 1 is configured to sequentially or substantially simultaneously drive a pump (pressure reducing mechanism) 8 connected to a puncturing mechanism 4 described later by pressing the operation button 222.

Further, the power of the body fluid component measurement device 1 may be turned on by pressing the operation button 222.

A printed circuit board 10 is provided on the lower side of the display unit 12 in fig. 1, and a control mechanism 11 formed of a microcomputer is mounted on the printed circuit board 10. The control means 11 controls various operations of the liquid component measurement device 1, for example, determination of whether or not blood is collected. The control means 11 incorporates a calculation section for calculating the amount of glucose (blood glucose level) in the blood based on the signal from the measurement means 7.

A pump 8 as a pressure reducing mechanism (suction mechanism) is provided on the lower left side of the printed circuit board 10 in fig. 1. The pump 8 is electrically driven and is connected to a pipe 81 through a ventilation passage 54 formed in a housing 5 described later. The pipe 81 has flexibility and is made of a polymer material such as polyolefin, e.g., polyvinyl chloride, polyethylene, polypropylene, ethylene-vinyl acetate copolymer (EVA), polyamide, polyester, silicone rubber, polyurethane, or the like.

The pump 8 sucks and discharges air in the cavity 52 of the housing 5, thereby bringing the cavity 52 of the housing 5 into a pressure-reduced state.

The pump 8 may reduce the pressure in the inner cavity 52 of the housing 5 and the finger puncture site to such a level that blood is sucked from the finger puncture site (for example, to a level of 100 to 400 mmHg).

On the lower right side in fig. 1 of the printed circuit board 10, a battery 9 as a power source is provided. The battery 9 is electrically connected to the pump 8, the solenoid valve 26, the control mechanism 11, the display unit 12, and the like, and supplies electric power necessary for driving these components.

A measurement unit 7 is disposed immediately before the pump 8 in fig. 1. The measuring means 7 optically detects the supply (collection) of blood to a test strip 18 provided in the puncture instrument 13 described later, and optically measures the amount of glucose in the blood scattered on the test strip 18 at a position near the position side of the test strip 18 in a state where the puncture instrument 13 is attached to and held in the case 5.

Accordingly, since the measurement means 7 has both a function of detecting the collection of blood and a function of measuring the amount of glucose (predetermined component) in blood scattered on the test strip 18, the number of parts can be reduced, the configuration can be simplified, and the number of assembly steps of the apparatus can be reduced as compared with a case where such an apparatus is provided at each position.

The measurement unit 7 includes a light emitting element (light emitting diode) 71 and a light receiving element (photodiode) 72.

The light emitting element71 is electrically connected to the control means 11, and the light receiving element 72 is electrically connected to the control means 11 through the amplifier 24 and the a/D converter 25.

The light emitting element 71 emits light when driven by a signal from the control means 11. The light is preferably pulsed light that intermittently emits light at given time intervals.

When the light emitting element 71 is caused to emit light in a state where the puncture instrument 13 is mounted in the housing 5, the test paper 18 is irradiated with light emitted from the light emitting element 71, the reflected light is received by the light receiving element 72, photoelectric conversion is performed, an analog signal corresponding to the amount of light received is output from the light receiving element 72, the signal is amplified to a desired signal by the amplifier 24, converted to a digital signal by the a/D converter 25, and input to the control mechanism 11.

The control means 11 determines whether or not blood is collected based on the input signal, that is, whether or not blood is scattered on the test paper 18 of the puncture instrument 13.

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

A housing 5 and a puncture instrument retraction mechanism 6 connected to the proximal end side of the housing 5 are provided on the front side of the measurement mechanism 7 in fig. 1, and the housing 5 incorporates the puncture mechanism 4.

The puncture device retracting mechanism 6 is fixed to the frame 21, while the housing 5 is not fixed to the frame 21 but is provided movably in the axial direction (the left-right direction in fig. 1) thereof by the puncture device retracting mechanism 6.

As described above, the body fluid component measurement device 1 is used by mounting the puncture instrument 13 in the housing 5. As shown in fig. 2, the puncture device 13 includes a puncture needle 14, a first case 15 that slidably accommodates the puncture needle 14, a second case 16 provided on an outer peripheral portion of the first case 15, a strip fixing portion 17 provided on an outer peripheral portion of the second case 16, and a strip 18 fixed to the strip fixing portion 17.

The puncture needle 14 is composed of a needle body 141 and a shank 142 fixed to the proximal end side of the needle body 141, and is accommodated in the cavity portion 152 of the first casing 15.

The needle body 141 is made of a hollow member or a solid member made of a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, a titanium alloy, or the like, and a sharp blade tip (needle point) is formed at the front end thereof to pierce the epidermis (skin) of a fingertip.

The stem 142 is substantially composed of a columnar member, and an outer peripheral portion thereof slides in contact with an inner peripheral surface of the first housing 15.

A reduced diameter portion 143 having a reduced diameter is formed at the proximal end portion of the stem 142. The reduced diameter portion 143 is fitted to a needle holder 411 of the plunger 41 constituting the puncture mechanism 4 described later.

The first casing 15 is formed of a bottomed cylindrical member having a bottom portion formed by a wall portion 153, and an inner cavity portion 152 is formed inside thereof.

A hole 154 having a circular cross-sectional shape is formed in a substantially central portion of the wall portion 153. The needle body 141 passes through the hole 154 when piercing the epidermis of the fingertip (finger). Further, the hole 154 is set to have a hole diameter smaller than the outer diameter of the front end of the shank 142. Therefore, when the puncture needle 14 is moved in the distal end direction of the inner chamber portion 152 and the distal end of the stem 142 is brought into contact with the proximal end of the wall portion 153, the puncture needle 14 can be prevented from being excessively moved in the distal end direction. Therefore, when the needle body 141 pierces a fingertip, the length of projection from the distal end of the puncture instrument 13 is kept constant. Therefore, the cutting edge of the needle body 141 can be reliably prevented from puncturing too deeply and excessively.

Further, a mechanism for adjusting the distance of movement of the plunger 41 described later is provided, whereby the depth of penetration of the tip of the needle body 141 into the fingertip can be adjusted.

A second casing 16 is fixed to an outer peripheral portion of the first casing 15.

The second housing 16 is formed of a substantially cylindrical member, and an inner cavity 161 is formed therein.

An abutting portion 163 protruding in an annular shape is formed at the front end of the second housing 16. The abutting portion 163 is a portion (i.e., a stopper) against which a tip is pressed, and a front end opening (opening) 162 that opens the cavity 161 is formed inside. The outer peripheral edge of the tip of the abutting portion 163 is shaped such that: is suitable for alleviating the stimulation around the puncture and the pain during the puncture when the fingertip is pressed against the puncture pad; in addition, the shape is also made as follows: when the pressureis reduced by the pump 8, the inflow of air from between the tip of the abutting portion 163 and the surface of the fingertip can be suppressed as much as possible. The front end surface of the second casing 16 may be a flat surface without providing the abutting portion 163 at the front end of the second casing 16.

An annular flange 164 protruding outward is formed on the outer peripheral portion of the second housing 16 near the base end of the abutment portion 163. In a state where the annular flange 164 is attached to a housing 5 described later, a base end thereof is in contact with a front end of the housing 5, and defines a position relative to the housing 5.

A recess 165 is formed in the outer periphery of the second housing 16, and a strip fixing portion 17 for mounting a disk-shaped strip 18 is attached to the recess 165.

Further, a blood introduction guide member 166 protruding into the inner chamber 161 is formed on the inner peripheral surface of the second housing 16. The blood introduction guide member 166 has a function of receiving blood (specimen) that has flowed into the lumen 161 from the distal end opening 162 after puncturing the fingertip.

In the puncture instrument 13, a blood passage 19 is formed to communicate the inner cavity 161 of the second case 16 with the outside via the second case 16 and the strip fixing portion 17. The blood passage 19 is a channel for guiding the punctured blood to the test paper 18, and has a passage opening 191 that opens to the inner chamber 161 and a passage opening 192 that opens to the outside of the puncture instrument 13. In addition, the passage opening 192 is located at the center of the test paper 18.

Blood introduction guide member 166 is formed near passage opening 191. Therefore, the blood received by the blood introduction guide member 166 is more efficiently guided from the passage opening 191 to the blood passage 19. The blood reaches the passage opening 192 by capillary action, and is supplied to the center portion of the test paper 18 provided so as to close the passage opening 192, and is scattered radially.

The test strip 18 is a carrier that absorbs and disperses blood and holds a reagent. The support may be a sheet-like porous body such as a nonwoven fabric, a woven fabric, or a stretched sheet. The porous body is preferably hydrophilic.

The reagent held on the carrier can be appropriately determined depending on the component to be measured in blood (specimen). For example, in the case of measuring blood glucose level, for example, Glucose Oxidase (GOD), Peroxidase (POD), and a color-developing agent (color-developing reagent) such as 4-aminoantipyrine and N-ethyl-N- (2-hydroxy-3-sulfopropyl) -m-toluidine may be used, and in addition, for example, a color-developing agent (color-developing reagent) that reacts with blood components such as ascorbate oxidase, alcohol oxidase, and cholesterol oxidase and the like may be used depending on the measurement component. In addition, a buffer such as phosphate buffer may be contained. It goes without saying that the kind and components of the reagent are not limited thereto.

The puncture instrument 13 is detachably attached (fitted) to the housing 5 (fitting portion 53) through the opening 212 of the frame 21.

As shown in fig. 3 and 4, the case 5 is formed of a bottomed cylindrical member having a bottom portion defined by a wall portion 51, and an inner cavity portion (housing space) 52 is formed inside the case. Further, a fitting portion 53 whose inner diameter is reduced in diameter in accordance with the outer peripheral shape of the puncture instrument 13 is formed on the distal end side of the housing 5. The puncture instrument 13 is inserted into the fitting portion 53 and fitted (fixed) thereto. In fig. 3 and 4, the configuration of the puncture instrument 13 is shown in a simplified manner for the sake of easy understanding of the explanation.

A ventilation passage 54 is formed in a side portion of the housing 5 to communicate the inner chamber 52 with the outside. The vent passage 54 is connected to the pump 8 through a pipe 81. The air in the lumen portion 52 is sucked by the pump 81 through the ventilation passage 54 and the tube 81, and the lumen portion 52 (including the puncture instrument 13) is brought into a reduced pressure state.

As shown in fig. 5, one end of the pipe 82 is connected to the middle of the pipe 81, and the other end of the pipe 82 is open to the outside of the body 21. The tube 82 is flexible and is 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 pipe 82.

When the electromagnetic valve 26 is closed (in a closed state), the reduced pressure state of the inner chamber 52 (including the puncture instrument 13) is maintained, and when the electromagnetic valve 26 is opened (in an open state), air (atmosphere) is introduced from the outside into the inner chamber 52 in the reduced pressure state through the tubes 82 and 81 and the ventilation passage 54, and the reduced pressure state is released or relaxed.

Therefore, the pressure reduction release mechanism is constituted by the pipes (flow paths) 81 and 82 and the electromagnetic valve 26.

As shown in fig. 3 and 4, a hole 511 is formed in the wall 51 of the housing 5 substantially at the center thereof. In the hole 511, a narrow tube 65 having an orifice (passage) 651 formed therein is provided. Air can flow through the orifice 651 between the inner chamber 52 provided on both sides of the narrow tube 65 and a variable volume chamber 631 described later.

An annular seal ring (seal member) 55 is fitted to the front end of the housing 5. Therefore, when the puncture instrument 13 is mounted in the housing 5, the proximal end of the flange 164 of the puncture instrument 13 contacts the seal ring 55, and the airtightness of the inner cavity 52 is maintained.

The seal ring 55 is made of an elastomer. Examples of the elastomer include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, styrene butadiene rubber, acrylonitrile butadiene rubber, chloroprene rubber, isobutylene rubber, acrylic rubber, ethylene-propylene rubber, chlorothalonil rubber, urethane rubber, silicone rubber, and fluororubber, and various thermoplastic elastomers such as styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, and fluororubber.

The housing 5 has an annular flange 56 projecting outward on the outer periphery of its base end portion, and a cylindrical projection 59 on its base end.

The puncture mechanism 4 is accommodated in the cavity 52 on the proximal end side from the fitting portion 53 of the housing 5. The puncture mechanism 4 moves the puncture needle 14 attached thereto in the distal direction, and punctures the surface of the fingertip by the blade tip of the needle body 141.

The puncture mechanism 4 includes a plunger 41, a coil spring (urging member) 42 that urges the plunger 41 in the distal direction, and a coil spring (urging member) 43 that urges the plunger 41 in the proximal direction.

A cup-shaped needle holder 411 is provided at the tip end of the plunger 41. The reduced diameter portion 143 of the puncture needle 14 is detachablyfitted to the needle holder 411. Further, an elastically deformable elastic piece 412 is provided at the base end portion of the plunger 41, and a convex engaging portion 413 is provided at the tip end of the elastic piece 412.

In a state before the puncture instrument 13 is mounted to the housing 5, that is, in a state before the puncture needle 14 is mounted to the plunger 41 (see fig. 3), the engaging portion 413 is urged upward in fig. 3 by the elastic force of the elastic piece 412 to contact the inner peripheral surface of the housing 5. On the other hand, in a state in which the puncture instrument 13 is mounted to the housing 5, that is, in a state in which the puncture needle 14 is mounted to the plunger 41 (see fig. 4), the engagement portion 413 is inserted into an opening 57 formed through the inside and outside of the housing 5 and engaged with an edge portion thereof. Thereby, the plunger 41 is restricted from moving in the front direction. The opening 57 is sealed by a flat plate-like sealing member (sealing member) 58, and the airtightness of the inner cavity 52 is maintained. The seal member 58 is made of the same material as the seal ring 55.

A coil spring (puncture spring) 42 is provided on the proximal end side of the plunger 41, and both ends thereof are in contact with the plunger 41 and the wall 51, respectively. On the other hand, a coil spring (return spring) 43 is provided on the tip side of the plunger 41, and both ends thereof are in contact with the plunger 41 and the fitting portion 53, respectively.

As shown in fig. 3 and 4, an engagement releasing member 223 capable of moving the engaging portion 413 into the inner cavity 52 (in the direction indicated by the arrow in the figure) is provided outside the housing 5. The engagement releasing member 223 moves in conjunction with the pressing of the operation button 222.

In a state where the engaging portion 413 is engaged with the opening 57, the coil spring 42 is in a compressed state, and biases the plunger 41 in the front end direction. When the operation button 222 is pressed to move the engagement releasing member 223 in the direction indicated by the arrow in the figure to release the engaged state of the engaging portion 413, the coil spring 42 is expanded to move the plunger 41 in the distal direction, and the tip of the needle body 141 punctures the surface (skin) of the fingertip.

On the other hand, at this time, the coil spring 43 is compressed to urge the plunger 41 in the proximal direction, that is, to press the plunger 41 in the proximal direction. Thereafter, the plunger 41 performs damping movement and is stationary at a position where the elastic force of the coil spring 42 and the elastic force of the coil spring 43 are balanced.

In a state where the plunger 41 is stationary, the blade edge of the needle body 141 is placed in the puncture instrument 13.

A puncture instrument retracting mechanism 6 is provided on the proximal end side of the housing 5.

The puncture instrument retracting mechanism 6 can move the housing 5 and the puncture instrument 13 mounted in the housing 5 in a direction (proximal direction) away from the fingertip 200.

As shown in fig. 5 to 10, the puncture instrument retraction mechanism 6 includes a main body 61, a seal ring 64, and a narrow tube 65.

The main body 61 is a bottomed cylindrical member having a bottom portion formed by the wall portion 62, and an inner cavity 63 is formed therein. The base end side of the housing 5 is inserted into the cavity portion 63.

An annular projection 611 projecting toward the center thereof is formed at the front end of the body 61. In a state before the puncture instrument retraction mechanism 6 is driven, the base end of the protrusion 611 comes into contact with the tip end of the flange 56. Thereby, the movement of the housing 5 in the front end direction is restricted. That is, the housing 5 can be prevented from being pulled out from the body portion 61.

At this time, the tip of the abutting portion 163 is located at substantially the same position as the finger stop surface 31, or slightly protrudes from the finger stop surface 31 (see fig. 5). Thereby, when the fingertip 200 contacts the stopper portion 3, the surface of the fingertip 200 can reliably contact the abutting portion 163, and the front end opening 162 is closed.

A recess 621 having a circular cross-sectional shape is formed in the center of the wall 62. The diameter of the concave portion 621 is set to be 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 to be substantially equal to the inner diameter of the body 61. With this configuration, for example, a vertical displacement (a displacement of the center of the housing 5 and the main body 61) in the drawing can be more reliably prevented regardless of the axial position of the housing 5.

An annular seal ring 64 is provided on the outer periphery of the projection 59, i.e., between the base end of the housing 5 and the leading end side surface 622 of the wall 62. The seal ring 64 hermetically seals the proximal end of the housing 5 and the surface 622, respectively. In this way, a volume variable chamber (decompression chamber) 631 having airtightness 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 biases the housing 5 in the distal direction by its elastic force in the driving state (the state shown in fig. 8) of the puncture instrument retracting mechanism 6. In other words, the seal ring 64 also functions as a biasing mechanism. The elastomer may be made of the same material as the seal ring 55.

The narrow tube 65 is formed of a cylindrical member. An orifice (passage) 651 is formed therein. The orifice 51 is a passage that communicates the inner chamber 52 of the housing 5 with the volume variable chamber 631, and has a small diameter structure, so that the resistance to the passage of air is relatively large, and the diameter of the orifice 651 is not particularly limited, but is preferably about 0.01 to 0.3mm, for example. By setting the diameter of the orifice 651 within the above range, a necessary and sufficient resistance to the passage (flow) of air can be obtained.

By adjusting the diameter of the orifice 651, the start timing of the driving of the pump 8 and the driving of the puncture instrument retraction mechanism 6 can be adjusted.

The number of thin tubes 65 is not limited to the illustrated configuration, and may be as many as necessary.

When the pump 8 is driven in a state where the tip end opening 162 is closed by the finger tip 200 contacting the abutment 163 by the puncture instrument retraction mechanism 6, the cavity 52 (including the interior of the puncture instrument 13) is first brought into a pressure reduction state, and the air in the variable volume chamber 631 flows into the cavity 52 through the orifice 651, whereby the pressure reduction of 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 puncture device 13 mounted in the housing 5 gradually move ina direction away from the fingertip 200.

Next, when the base end 591 of the protrusion 59 comes into contact with the bottom surface of the recess 621, the movement of the housing 5 and the puncture instrument 13 mounted in the housing 5 in the base end direction is stopped (see fig. 8). Therefore, by adjusting the axial length of the projection 59, the puncture instrument 13 can be prevented from excessively separating from the fingertip 200. In other words, the projection 59 and the bottom surface of the recess 621 in contact therewith constitute a mechanism (movement distance specifying mechanism) for specifying the movement distance (maximum retreat distance) of the puncture instrument 13 from the fingertip 200.

The distance between the puncture instrument 13 and the fingertip 200 (the maximum retreat distance of the puncture instrument 13) is not particularly limited, but is preferably about 0.2 to 2.5mm, and more preferably about 0.5 to 1.5 mm. By setting the separation distance within the above range, a sufficient amount of blood can be ensured more reliably and in a shorter time. In addition, the fingertip 200 can be reliably prevented from coming loose from the distal end opening 162.

The puncture instrument retraction mechanism 6 is driven in accordance with the driving of the pump 8. That is, the puncture instrument retracting mechanism 6 decompresses the inner chamber 52 by the pump 8, sucks the fingertip 200 to the distal end opening 162, and then gradually retracts (moves) the puncture instrument 13 in the proximal end direction. Therefore, the puncture device retracting mechanism 6 can move the puncture device 13 away from the fingertip 200 while maintaining the pressure-reduced state of the puncture site 210 of the fingertip 200.

The puncture instrument retraction mechanism 6 is driven by a decompression force generated by the pump 8. That is, the pump (pressure reducing mechanism) 8 may be considered as one of the components of the puncture instrument retracting mechanism 6.

In addition, since the puncture instrument retraction mechanism 6 does not require an additional drive source, it is advantageous for the size and weight of the body fluid component measurement device 1 and for the reduction of the manufacturing cost.

In addition, with this body fluid component measurement device 1, when the fingertip 200 is pressed against the stopper 3 as shown in fig. 6, the surface of the fingertip 200 comes into contact with the tip of the abutment portion 163, and the capillary blood vessels around the puncture site 210 are pressed by the tip of the abutment portion 163, so that the puncture site 210 of the fingertip 200 can be maintained in a depressurized state, and the puncture instrument 13 can be moved away from the fingertip 200, and therefore, the capillary blood vessels around the puncture site 210 pressed by the tip of the abutment portion 163 are opened, and the blood 220 can be sucked out from the puncture site 210 more reliably and in a short time, and a sufficient amount of blood required for measuring the amount of glucose can be secured.

In the driving state (the state shown in fig. 8) of the puncture instrument retracting mechanism 6, the housing 5 is moved in the proximal direction, and the seal ring 64 is in a compressed state. As described above, since the seal ring 64 is made of an elastic body, the housing 5 is urged in the distal direction in the state shown in fig. 8. Thus, when the solenoid valve 26 is opened and the pressure reduction state is released, the seal ring 64 returns to its original shape by its own elastic force, and the housing 5 is moved in the front end direction (see fig. 9 and 10). At this time, the front end of the flange 56 of the housing 5 contacts the base end of the protrusion611 of the body portion 61, and excessive movement in the front end direction is restricted (see fig. 10). That is, the housing 5 and the puncture instrument 13 mounted therein return to the position before the puncture instrument retracting mechanism 6 is driven.

Next, the operation of each part and the control operation of the control means in the case of performing puncturing, blood collection and distribution, and blood glucose level measurement with the body fluid component measurement apparatus 1 will be described with reference to the flowchart shown in fig. 2 to 10 and 12.

First, the puncture instrument 13 is inserted into the fitting portion 53 of the housing 5 through the opening 212 of the frame 21, and the reduced diameter portion 143 of the puncture needle 14 is fitted to the needle holder 411 (see fig. 4).

Subsequently, when the puncture instrument 13 is pushed in the proximal direction, the plunger 41 is moved in the proximal direction against the elastic force of the coil spring 42. The engaging portion 413 is urged by the elastic force of the elastic piece 412 to contact the inner peripheral surface of the inner cavity portion 52, and is inserted into the opening 57 when the engaging portion 413 is at the position of the opening 57 (see fig. 4). Thus, even when the pressing force in the proximal direction of the puncture instrument 13 is released, the engaging portion 413 engages with the opening 57, and 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, the preparation for puncturing by the puncturing mechanism 4 and the preparation for collecting blood (sample) are finished.

Then, a power switch not shown in the figure is turned on, and each part of the body fluid component measuring apparatus 1 is started to be in a measurable state. In addition, the electromagnetic valve 26 is closed.

Next, the fingertip (finger) 200 is pressed against the stopper 3. Thereby, the fingertip 200 is pressed against the abutting portion 163 of the puncture instrument 13. At this time, the tip opening 162 is closed with the fingertip 200 (see fig. 5) so as to reduce air leakage as much as possible.

Then, the operation button 222 is pressed and operated to puncture the front surface of the fingertip 200 (step S1 in fig. 12).

When the operation button 222 is pressed, the engagement releasing member 223 connected to the operation button 222 moves downward in fig. 4. Thereby, the engagement releasing member 223 comes into contact with the engagement portion 413, and the engagement portion 413 is pressed back to the inner cavity portion 52 side. Thus, the engagement of the engaging portion 413 is released, and the plunger 41 is moved in the distal direction by the elastic force of the compressed coil spring 42, so that the needle body 141 is projected from the distal opening 162 to puncture the surface of the fingertip 200 (see fig. 6). Bleeding occurs from the puncture site 210 of the needle body 141.

Further, the drive switch (not shown) of the pump 8 is also turned on substantially at the same time by the pressing of the operation button 222.

When the needle body 141 pierces the fingertip 200, the coil spring 43 pushes the plunger 41 in the proximal direction. After the damping movement, the plunger 41 is at rest at a position where the elastic force of the coil spring 42 and the elastic force of the coil spring 43 are balanced (see fig. 7). At this time, the blade tip of the needle body 141 is accommodated in the puncture instrument 13. Therefore, the blade edge of the needle body 141 does not protrude from the distal end opening 162 except during puncturing. Can eliminate the phenomenon of skin injury by mistake, and can prevent infection with good safety.

When the drive switch of the pump 8 is turned on, the control means drives the pump 8 (step S2 in fig. 12).

In other words, the pump 8 is driven substantially simultaneously with the operation [ 4]described above, and the air suction in the cavity portion 52 of the housing 5 is started. This reduces the pressure in the inner chamber 52 (including the puncture instrument 13) to a reduced pressure state.

At this time, the puncture site 210 of the needle body 141 of the fingertip 200 is also in a decompressed state. However, in this state, the fingertip 200 positioned inside the abutting portion 163 (the distal end opening 162) bulges into the puncture instrument 13, and is formed into a hill shape, and presses the capillary at the peripheral portion of the puncture site 210 abutting against the distal end of the abutting portion 163.

Further, when the suction of the inner chamber 52 of the pump 8 is continued, the air in the variable volume chamber 631 gradually flows out to the inner chamber 52 through the orifice 651, and the volume of the variable volume chamber 631 gradually decreases. Thereby, the housing 5 and the puncture instrument 13 mounted therein start to move gradually in the proximal direction, i.e., in the direction away from the fingertip 200.

At this time, since the decompression state of the inner cavity 52 and the puncture site 210 of the fingertip 200 is continuously maintained, the fingertip 200 does not come loose from the distal end opening 162. Further, even if the puncture instrument 13 moves in a direction away from the fingertip 200, the fingertip 200 contacts the stopper 3, and therefore does not move with the puncture instrument 13. Therefore, the puncture instrument 13 can be reliably separated from the fingertip 200.

When the puncture instrument 13 is separated from the fingertip 200, the capillary vessels in the vicinity of the puncture site 210 pressed by the tip of the abutment portion 163 gradually open, and blood 220 can be aspirated from the puncture site 210 (see fig. 8). In other words, bleeding is promoted and a required amount of blood can be secured in a short time as compared with the case where the fingertip 200 and the puncture instrument 13 are not separated.

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

Next, the base end 591 of the convex portion 59 is in contact with the bottom surface of the concave portion 621. Thereby, the movement of the housing 5 and the puncture instrument 13 contained therein in the proximal direction is stopped. Accordingly, since the puncture instrument 13 can be stopped at a place between appropriate distances from the fingertip 200, the fingertip 200 does not come loose from the front end opening 162. This can more reliably prevent scattering of blood 220 aspirated from puncture site 210 and contamination of the surroundings, and improve safety.

As described above, the body fluid component measuring apparatus 1 can perform the puncturing operation and the pressure reducing operation substantially simultaneously by one-time pressing of the operation button 222, and the retraction operation of the puncture instrument 13 is also performed by the pressure reducing force of the pump 8, and the pressure reducing releasing operation described later can be automatically started, so that the operability is very good.

In the operation [ 7]above, blood 220 that has risen up in the form of particles at the puncture site 210 is sucked into the puncture instrument 13, comes into contact with the blood introduction guide member 166 formed inside thereof, is introduced into the test paper 18 through the blood passage 19, is supplied to the center of the test paper 18, and spreads radially (see fig. 2).

As the blood 220 is supplied to and scattered from the test strip 18, the glucose (component to be measured) in the blood 220 reacts with the reagent held on the test strip 18, and the test strip 18 develops color in accordance with the amount of glucose.

On the other hand, after step S2 shown in fig. 12 is performed, the control means 11 drives the measurement means 7, monitors (monitors) the color development of the test strip 18 by the measurement means 7, and determines whether or not blood is collected (step S3 shown in fig. 12).

In step S3, it is determined that blood has been collected when the voltage value of the signal input from the light-receiving element 72 of the measurement device 7 exceeds a preset limit value, and it is determined that blood has not been collected when the voltage value is lower than the preset limit value.

The above limit values are set as: the voltage value of the signal before the color development of the test paper 18 is very large and the voltage value of the signal during the color development is very small.

If it is determined in step S3 that blood has not been collected, it is determined whether or not the time has elapsed (step S4 in fig. 12).

In the case where it is determined in the above step S4 that the time has not elapsed, the process returns to step S2, the process from step S2 is performed again, and when it is determined that the time has elapsed, the error process is performed (step S5 in fig. 12).

In step S5, the pump 8 is stopped, the electromagnetic valve 26 is opened, the reduced pressure state is released, andthe display unit 12 displays an indication (error indication) indicating the cause of the error.

The operator (user) can grasp the error based on the error indication (any trouble).

The function of the solenoid valve 26 when opened will be described in detail below.

In step S3, if it is determined that blood has been collected, the pump 8 is stopped (step S6 in fig. 12).

Subsequently, the electromagnetic valve 26 is opened to release the pressure reduction state (step S7 in fig. 12).

When the electromagnetic valve 26 is opened, the outside air (atmosphere) flows into the inner cavity 52 (including the puncture device 13) and the puncture site 210 through the tubes 82 and 81 and the ventilation passage 54, and returns the inner cavity 52 (including the puncture device 13) and the puncture site 210 to the atmospheric pressure (see fig. 9).

The seal ring 64 returns to its original shape by its own elastic force, and moves the housing 5 in the front end direction (see fig. 9 and 10). At this time, the distal end of the flange 56 of the housing 5 contacts the proximal end of the projection 611 of the main body 61, and the excessive movement of the housing 5 in the distal direction is restricted (see fig. 10).

If it is confirmed that the suction feeling of the peripheral portion of the puncture site 210 of the fingertip 200 is eliminated and the pressure is returned to the atmospheric pressure, the fingertip 200 is separated from the abutting portion 163 of the puncture instrument 13.

After step S shown in fig. 12 is performed, the control means 11 measures the degree of color development of the test strip 18 by the measuring means 7, and performs correction such as calculation, temperature correction calculation, and hematocrit value correction calculation based on the obtained data to quantify the blood glucose level (step S8 in fig. 12).

In this case, since the reduced pressure state of the inner chamber section 52 (including the puncture instrument 13), that is, the reduced pressure state of the housing space of the test strip 18 is released, the atmospheric components necessary for the reaction between the glucose (component to be measured) in the blood 220 and the reagent held on the test strip 18 can be sufficiently supplied, and thus the blood glucose level can be measured more accurately.

Next, the calculated blood glucose level is displayed on the display unit 12 (step S9 in fig. 12).

This makes it possible to grasp the blood glucose level.

As described above, according to the body fluid component measuring apparatus 1, a sufficient amount of blood necessary for measurement can be collected reliably in a short time, and the blood glucose level (the amount of a predetermined component in the blood) can be measured accurately and reliably.

Further, since the puncture instrument 13 is provided with the test paper 18, puncture, collection of blood, and scattering and measurement (quantification of components) on the test paper 18 can be performed continuously, and thus, measurement of blood glucose level (component measurement) can be easily performed in a short time.

Since the preparation operation in use is easy, it is also advantageous in the case of regular use or repeated use.

The safety is improved by preventing an accident such as erroneous re-piercing of the living body surface after the piercing. Further, since the puncture needle 14 is not directly visible, the fear of puncture is also reduced.

As can be seen from the above, the body fluid component measuring apparatus 1 is suitable for use in a case where a patient measures his/her own blood glucose level or the like.

In addition, the body fluid component measuring apparatus 1 is simple in structure, small in size, light in weight, and inexpensive, and therefore is also suitable for mass production.

Next, a second embodiment of the body fluid component measuring device according to the first embodiment of the present invention will be described. The body fluid component measurement device of the second embodiment is different from the body fluid component measurement device of the first embodiment in the configuration of the decompression release mechanism.

Fig. 13 is a vertical sectional view showing an example of the main part configuration of the body fluid component measuring device according to the second embodiment, and fig. 14 is a block diagram showing the circuit configuration of the body fluid component measuring device according to the second embodiment.

Hereinafter, differences from the body fluid component measuring device of the first embodiment will be mainly described, and the description of the same matters will be omitted. In the following description, the right side of fig. 13 is referred to as the "base end" and the left side is referred to as the "tip end".

As shown in fig. 13 and 14, the body fluid component measuring device 1 of the second embodiment is provided with a narrow tube 83 instead of the electromagnetic valve 26 of the body fluid component measuring device 1 of the first embodiment.

The narrow tube 83 is formed of a cylindrical member, and a throttle (flow path) 831 is formed inside the tube. The narrow tube 83 is joined (connected) to an end of the tube 82, and a tip of the narrow tube 83 (the orifice 831) is opened to the outside of the main body 21.

The orifice 831 of the narrow tube 83 has a small diameter structure, and therefore, the resistance to the passage of air is relatively large. The diameter of the throttle 831 is not particularly limited, but is preferably about 0.01 to 0.3mm, for example. The length of the throttle 831 is not particularly limited, but is preferably about 5 to 15 mm. By setting the diameter of the orifice 831 within the above range, a necessary and sufficient resistance to the passage (flow) of air can be obtained.

The pipes (flow paths) 81 and 82 and the narrow pipe 83 constitute a decompression release mechanism.

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

Next, the operation of the body fluid component measurement device 1 of the first embodiment will be described mainly focusing on the differences from the body fluid component measurement device 1 with reference to a flowchart shown in fig. 12.

First, steps S1 to S6 shown in fig. 12 are basically the same as those of the body fluid component measurement device 1 according to the first embodiment.

In this case, in this body fluid component measuring apparatus 1, since the flow rate of air sucked by driving of the pump 8 is larger (more) than the flow rate of outside air (atmospheric air) flowing in from the orifice 831 of the narrow tube 83, when the pump 8 is driven in step S2, the suction of air in the cavity portion 52 of the housing 5 is started, whereby the pressure in the cavity portion 52 (including the inside of the puncture instrument 13) is reduced and the pressure is reduced.

Then, in step S6, when the pump 8 is stopped, the body fluid component measuring apparatus 1 stops the pump 8, and the outside air flows into the lumen portion 52 (including the puncture device 13) and the puncture site 210 through the orifice 831 of the narrow tube 83, the tubes 82 and 81, and the ventilation path 54, and the decompression state of the lumen portion 52 (including the puncture device 13) and the puncture site 210 is released (step S7 in fig. 12). In other words, the cavity 52 (including the puncture instrument 13) and the puncture site 210 are returned to the atmospheric pressure.

Hereinafter, steps S8 and S9 shown in fig. 12 are the same as those of the body fluid component measuring device 1 according to the first embodiment.

According to this body fluid component measurement device 1, the same effects as those of the body fluid component measurement device 1 of the first embodiment can be obtained.

Although the body fluid component measuring device according to the first aspect of the present invention has been described above based on the illustrated embodiments, the present invention is not limited to this, and for example, the configuration of each part may be replaced with any configuration that can exhibit the same function.

In the above-described embodiments, the components to be measured are exemplified by glucose (blood glucose level), but the components to be measured in the present invention are not limited thereto, and may be, for example, protein, cholesterol, uric acid, creatine amide, ethanol, sodium or other inorganic ions.

In the above embodiment, the blood collection detection means for detecting the collection of blood and the measurement means for measuring the amount of the predetermined component in the blood are provided in combination (in the embodiment, this means is referred to as "measurement means"), but the blood collection detection means and the measurement means may be provided separately in the present invention.

In the above embodiment, as the blood collection detection means, a means for optically detecting the collection of blood is used, but the present invention is not limited thereto, and other means for electrically detecting, for example, may be used.

In the present invention, when a blood collection and detection mechanism that optically detects collection of blood is used, the detection is not limited to color development (color development) of a test strip that detects a reaction between a component in blood and a reagent, and other cases, such as introduction of blood into a blood passage (blood channel) that supplies blood to a test strip of a puncture device, may be detected.

In the case of detecting the introduction of blood into the blood passage, for example, a configuration may be adopted in which at least a portion near the blood passage in the puncture instrument is formed by a member having translucency (transparency), light is irradiated to the blood passage via a blood collection and detection means, reflected light or transmitted light is received, photoelectric conversion is performed, and the voltage output by the blood collection and detection means is monitored via a control means. When blood is introduced into the blood passage, the color of the portion changes to substantially red-black, and therefore the amount of reflected light or transmitted light from the portion changes, the voltage output from the blood collection detection means changes, and blood collection can be detected by detecting the change in the output voltage (amount of light).

As the blood collection detection means for electrically detecting the blood collection, for example, a sensor (electrode) for detecting (measuring) the impedance of the blood path ofthe puncture device or the like, a biosensor, or the like can be used.

In the case of using the biosensor, for example, when blood is introduced into the blood channel, the current output from the biosensor changes, and therefore detection of the change in the output current (current value) enables detection of blood collection.

In addition, in the case of using a sensor for detecting the impedance, for example, when blood is introduced into the blood passage, the impedance between the sensor electrodes changes, and therefore, the detection of the change in the impedance enables detection of blood collection.

The body fluid component measuring apparatus of the present invention optically measures (colorimetrically measures) the color development intensity of the developed test strip by the reaction between the component in the blood and the reagent, and converts and displays the color development intensity into a measured value.

In the above embodiment, the reduced pressure state is released before the measurement, but in the present invention, a structure in which the reduced pressure state is relaxed before the measurement may be adopted.

In the present invention, the driving of the decompression mechanism and the puncture instrument retraction mechanism may be started manually or automatically. In the latter case, a sensor or the like for magnetically sensing the movement of the puncture needle in the distal direction when puncturing the fingertip is provided in the vicinity of the side surface of the fitting portion of the case, and the pressure reducing mechanism and the puncture instrument retracting mechanism are driven based on information from the sensor.

The body fluid component measuring device according to the second embodiment of the present invention will be described in detail below with reference to the preferred embodiments shown in the drawings.

In the following description, fig. 1 to 2, 5, 7 to 10, and 13 are the same as those of the body fluid component measuring device of the first embodiment, and these drawings are used herein.

Fig. 15 and 16 correspond to fig. 3 and 4 of the first embodiment, and are vertical sectional views of a puncture mechanism provided in a body fluid component measurement device according to a first embodiment of the second embodiment (hereinafter, the term "second embodiment") and an example of a housing configuration incorporating the puncture mechanism, respectively. Fig. 5, 17 to 18, and 7 to 11 are vertical sectional views showing an example of the main part configuration of the body fluid component measuring device according to the first embodiment, fig. 19 is a block diagram showing the circuit configuration of the body fluid component measuring device according to the first embodiment, and fig. 20 is a program block diagram showing the control operation of the control means of the body fluid component measuring device according to the first embodiment. In these drawings, the same reference numerals as those in fig. 1 to 14 denote the same or corresponding parts.

In these drawings, the right side of the drawing is referred to as the "base end" and the left side is referred to as the "tip end".

As shown in fig. 1, 5, and 19, a body fluid component measurement device (blood component measurement device) 1 according to a first embodiment includes: a body 2; a stopper portion 3 provided on the body 2; a puncture mechanism 4 housed in the housing 5; a puncture instrument retracting mechanism 6 provided on the proximal end side of the housing 5; a 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 inside the casing 5; a solenoid valve 26 for releasing, relaxing, or maintaining the pressure-reduced state in the case 5; a pressure sensor (pressure detection means) 27 that detects the pressure in the housing 5; a solenoid (drive source) 28; a switch 29; a battery (power supply) 9; a control mechanism 11 and a memory 33 provided on the printed circuit board 10; a display unit (notification means) 12; an audio output unit (notification means) 32; and an external output unit 34.

The body fluid component measuring apparatus 1 is used with the puncture device 13 shown in fig. 2 attached. The following describes each constituent element.

The main body 2 is composed of a frame 21 and a lid 22 facing each other. The main body 2 has a housing space 23 formed therein, and the puncture mechanism 4, the housing 5, the puncture instrument retracting mechanism 6, the measuring mechanism 7, the pump 8, the electromagnetic valve 26, the solenoid 28, the switch 29, the battery 9, the printed circuit board 10, the control mechanism 11, the memory 33, the display unit 12, the audio output unit 32, and the external output unit 34 are mounted in the housing space 23. In addition, a pressure sensor 27 is provided in the housing 5.

An opening 212 having a circular cross-sectional shape is formed through the inside and outside of the frame 21 in the wall portion 211 on the front end side of the frame 21. The puncture instrument 13 described later is attached (held) to the housing 5 through the opening 212.

Further, on the surface of the wall portion 211 on the front end side, around the outer periphery of the opening 212, a finger stopper (stopper against which the skin comes into contact) 3 formed in correspondence with the shape of a fingertip (finger) is provided. A finger stopper surface 31 is formed on the front endside of the stopper portion 3. The fingertip comes into contact with the finger stopper 3 (finger stopper surface 31) to drive the body fluid component measurement device 1. With this, the fingertip is punctured, and the amount of a predetermined component (hereinafter, in the present embodiment, glucose is described as a representative) in the collected blood is measured.

A display window (opening) 221 is formed on the upper surface of the cover 22 so as to penetrate the inside and outside of the cover 22, and the display window is covered with a plate-like member made of a transparent material.

A display unit 12 is provided at a position in the housing space 23 corresponding to the display window 221. Therefore, various information displayed by the display unit 12 can be confirmed through the display window 221.

The display unit 12 is formed of, for example, a liquid crystal display element (LCD). The display unit 12 can display, for example, on/off of a power supply, a power supply voltage (remaining battery level), a measurement value, a measurement date, an error display, a position correction display, an operation guide, and the like.

The sound output unit 32 is constituted by, for example, a buzzer (a device that generates a predetermined sound or melody), a sound emitting device, and the like.

The notification means is not limited to the above configuration, and may be other light emitting elements such as a Light Emitting Diode (LED) and an EL element, a lamp, an EL display element, and the like.

The external output unit 34 outputs the data of the obtained blood glucose level and the like to an external device such as a personal computer.

An operation button 222 is provided on the upper surface of the cover 22. The body fluid component measuring apparatus 1 is configured such that the switch 29, which is interlocked with the operation button 222, is turned on by pressing the operation button 222, and the signal is input from the switch 29 to the control means 11.

A printed circuit board 10 is provided on the lower side of the display unit 12 in fig. 1, and a control unit 11 formed of a microcomputer and a memory 33 are mounted on the printed circuit board 10. The control means 11 controls various operations of the liquid component measurement device 1, such as determination of whether or not blood is collected or not, determination of whether or not a reduced pressure state is present, and the like. The control means 11 incorporates a checking unit that calculates the amount of glucose (blood glucose level) in the blood based on the signal from the measurement means 7.

A pump 8 as a pressure reducing mechanism (suction mechanism) is provided on the lower left side of the printed circuit board 10 in fig. 1. The pump 8 is electrically driven and is connected to a pipe 81 through a ventilation passage 54 formed in a housing 5 described later. The pipe 81 has flexibility and is made of a polymer material such as polyolefin, e.g., polyvinyl chloride, polyethylene, polypropylene, ethylene-vinyl acetate copolymer (EVA), polyamide, polyester, silicone rubber, polyurethane, or the like.

The pump 8 sucks and discharges air in the cavity 52 of the housing 5, thereby bringing the cavity 52 of the housing 5 into a pressure-reduced state. In particular, in this body fluid component measurement device 1, before, simultaneously with, or after the puncture by the needle body 141 of the puncture instrument 13 described later, the pressure in the inner cavity 52 of the housing 5 is reduced by the pump 8.

The pump 8 may be a member for bringing the cavity 52 of the housing 5 and the finger puncturesite into a reduced pressure state to such an extent that blood is sucked from the finger puncture site (for example, to an extent of 100 to 400 mmHg).

A battery 9 as a power source is provided on the lower right side of the printed circuit board 10 in fig. 1. The battery 9 is electrically connected to the pump 8, the solenoid valve 26, the solenoid 28, the control mechanism 11, the display unit 12, the audio output unit 32, and the like, and supplies electric power necessary for driving these components.

A measurement unit 7 is disposed immediately before the pump 8 in fig. 1. The measuring means 7 optically detects the supply (collection) of blood to the test strip 18 provided with the puncture instrument 13 described later, and optically measures the amount of glucose in the blood scattered on the test strip 18 at a position near the position side of the test strip 18 in a state where the puncture instrument 13 is attached to and held in the case 5.

Accordingly, since the measurement means 7 has both a function of detecting the collection of blood and a function of measuring the amount of glucose (predetermined component) in blood scattered on the test strip 18, the number of parts can be reduced, the configuration can be simplified, and the number of assembly steps of the apparatus can be reduced as compared with a case where such means is provided at each position.

The measurement unit 7 includes 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 through the amplifier 24 and the a/D converter 25.

The light emitting element 71 is driven by a signalfrom the control means 11 to emit light. The light is preferably pulsed light that intermittently emits light at given time intervals.

When the light emitting element 71 is caused to emit light in a state where the puncture instrument 13 is mounted in the housing 5, the test paper 18 is irradiated with light emitted from the light emitting element 71, the reflected light is received by the light receiving element 72, photoelectrically changed, an analog signal corresponding to the amount of light received is output from the light receiving element 72, amplified by the amplifier 24 to a desired signal, converted into a digital signal by the a/D converter 25, and input to the control mechanism 11.

The control means 11 determines whether or not blood is collected based on the input signal, that is, whether or not blood is scattered on the test paper 18 of the puncture instrument 13.

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

A housing 5 and a puncture instrument retraction mechanism 6 connected to the proximal end side of the housing 5 are provided on the front side of the measurement mechanism 7 in fig. 1, and the housing 5 incorporates the puncture mechanism 4.

The puncture device retracting mechanism 6 is fixed to the frame 21, while the housing 5 is not fixed to the frame 21 but is provided movably in the axial direction (the left-right direction in fig. 1) thereof by the puncture device retracting mechanism 6.

As described above, the body fluid component measurement device 1 is used by mounting the puncture instrument 13 in the housing 5. The puncture instrument 13 has the same configuration as that described in the first embodiment of the present invention, and the description thereof is omitted here.

The puncture instrument 13 is detachably attached (fitted) to the housing 5 (fitting portion 53) through the opening 212 of the frame 21.

As shown in fig. 15 and 16, the case 5 is formed of a bottomed cylindrical member having a bottom portion defined by a wall portion 51, and an inner cavity portion (housing space) 52 is formed inside the case. Further, a fitting portion 53 whose inner diameter is reduced in diameter in accordance with the outer peripheral shape of the puncture instrument 13 is formed on the distal end side of the housing 5. The puncture instrument 13 is inserted into the fitting portion 53 and fitted (fixed) thereto. Fig. 15 and 16 show examples. The structure of the puncture instrument 13 is shown in a simplified manner for the sake of easy understanding of the explanation.

A ventilation passage 54 is formed in a side portion of the housing 5 to communicate the inner chamber 52 with the outside. The vent passage 54 is connected to the pump 8 through a pipe 81. The air in the lumen portion 52 is sucked by the pump 81 through the ventilation passage 54 and the tube 81, and the lumen portion 52 (including the puncture instrument 13) is brought into a reduced pressure state.

As shown in fig. 5, one end of the pipe 82 is connected to the middle of the pipe 81, and the other end of the pipe 82 is open to the outside of the body 21. The tube 82 is flexible and is 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 pipe 82.

When the electromagnetic valve 26 is closed (in a closed state), the reduced pressure state of the inner chamber 52 (including the puncture instrument 13) is maintained, and when the electromagnetic valve 26 is opened (in an open state), air (atmosphere) is introduced from the outside into the inner chamber 52 in the reduced pressure state through the tubes 82 and 81 and the ventilation passage 54, and the reduced pressure state is released or relaxed.

Therefore, the pressure reduction release mechanism is constituted by the pipes (flow paths) 81 and 82 and the electromagnetic valve 26.

As shown in fig. 15 and 16, a hole 511 is formed in the wall 51 of the housing 5 substantially at the center thereof. In the hole 511, a narrow tube 65 having an orifice (passage) 651 formed therein is provided. Air can flow through the orifice 651 between the inner chamber 52 provided on both sides of the narrow tube 65 and a variable volume chamber 631 described later.

An annular seal ring (seal member) 55 is fitted to the front end of the housing 5. Therefore, when the puncture instrument 13 is mounted in the housing 5, the proximal end of the flange 164 of the puncture instrument 13 contacts the seal ring 55, and the airtightness of the inner cavity 52 is maintained.

The seal ring 55 is made of an elastomer. Examples of the elastomer include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, styrene butadiene rubber, acrylonitrile butadiene rubber, chloroprene rubber, isobutylene rubber, acrylic rubber, ethylene-propylene rubber, chlorothalonil rubber, urethane rubber, silicone rubber, and fluororubber, and various thermoplastic elastomers such as styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, and fluororubber.

The housing 5 has an annular flange 56 projecting outward on the outer periphery of its base end portion, and a cylindrical projection 59 on its base end.

The puncture mechanism 4 is accommodated in the cavity 52 on the proximal end side from the fitting portion 53 of the housing 5. The puncture mechanism 4 moves the puncture needle 14 attached thereto in the distal direction, and punctures the surface of the fingertip by the blade tip of the needle body 141.

The puncture mechanism 4 includes a plunger 41, a coil spring (urging member) 42 that urges the plunger 41 in the distal direction, and a coil spring (urging member) 43 that urges the plunger 41 in the proximal direction.

A cup-shaped needle holder 411 is provided at the tip end of the plunger 41. The reduced diameter portion 143 of the puncture needle 14 is detachably fitted to the needle holder 411. Further, an elastically deformable elastic piece 412 is provided at the base end portion of the plunger 41, and a convex engaging portion 413 is provided at the tip end of the elastic piece 412.

In a state before the puncture instrument 13 is mounted to the housing 5, that is, in a state before the puncture needle 14 is mounted to the plunger 41 (see fig. 15), the engaging portion 413 is urged upward in fig. 15 by the elastic force of the elastic piece 412 to be in contact with the inner peripheral surface of the housing 5. On the other hand, in a state in which the puncture instrument 13 is mounted to the housing 5, that is, in a state in which the puncture needle 14 is mounted to the plunger 41 (see fig. 16), the engagement portion 413 is inserted into an opening 57 formed through the inside and outside of the housing 5 and engaged with an edge portion thereof. Thereby, the plunger 41 is restricted from moving in the front direction. The opening 57 is sealed by a flat plate-like sealing member (sealing member) 58, and the airtightness of the inner cavity 52 is maintained. The seal member 58 is made of the same material as the seal ring 55.

A coil spring (puncture spring) 42 is provided on the proximal end side of the plunger 41, and both ends thereof are in contact with the plunger 41 and the wall 51, respectively. On the other hand, a coil spring (return spring) 43 is provided on the tip side of the plunger 41, and both ends thereof are in contact with the plunger 41 and the fitting portion 53, respectively.

As shown in fig. 19, a pressure sensor 27 is provided in the housing 5, and the pressure in the cavity 52 (including the puncture instrument 13) of the housing 5 is detected by the pressure sensor 27. Information from the pressure sensor 27, that is, pressure (data) detected by the pressure sensor 27 is input to the control means 11.

As shown in fig. 15 and 16, a solenoid 28 is provided outside the housing 5 as a driving source for electric driving. The solenoid 28 is configured to: the plunger 281 can move the engaging portion 413 into the inner cavity 52 (in the direction of the arrow in the figure).

In a state where the engaging portion 413 is engaged with the opening 57, the coil spring 42 is in a compressed state, and biases the plunger 41 in the front end direction. When the plunger 281 of the solenoid 28 moves in a direction indicated by an arrow in the figure and the engagement of the engaging portion 413 is released by the plunger 281, the coil spring 42 expands and the plunger 41 moves in the tip direction, and the tip of the needle body 141 punctures the surface (skin) of a fingertip. Therefore, the solenoid 28 constitutes a drive start mechanism for starting the driving of the puncture mechanism 4.

On the other hand, at this time, the coil spring 43 is compressed to urge the plunger 41 in the proximal direction, that is, to press the plunger 41 in the proximal direction. Thereafter, the plunger 41 performs damping movement and is stationary at a position where the elastic force of the coil spring 42 and the elastic force of the coil spring 43 are balanced.

In a state where the plunger 41 is stationary, the blade edge of the needle body 141 is placed in the puncture instrument 13.

A puncture instrument retracting mechanism 6 is provided on the proximal end side of the housing 5. The puncture instrument retracting mechanism 6 is the same as the structure described in the first aspect of the invention, and a redundant description thereof is omitted here.

In addition, in the body fluid component measurement device 1, when the fingertip 200 is pressed against the stopper 3 as shown in fig. 17, the surface of the fingertip 200 comes into contact with the tip of the abutment portion 163, and the capillary blood vessels around the puncture site 210 are pressed by the tip of the abutment portion 163, as shown in fig. 8, so that the puncture site 210 of the fingertip 200 can be maintained in a depressurized state, and the puncture instrument 13 can be moved away from the fingertip 200, and therefore, the capillary blood vessels around the puncture site 210 pressed by the tip of the abutment portion 163 are opened, and the blood 220 can be sucked out from the puncture site 210 more reliably and in a short time, and a sufficient amount of blood required for measuring the amount of glucose can be secured.

In the driving state (the state shown in fig. 8) of the puncture instrument retracting mechanism 6, the housing 5 is moved in the proximal direction, and the seal ring 64 is in a compressed state. As described above, since the seal ring 64 is made of an elastic body, the housing 5 is urged in the distal direction in the state shown in fig. 8. Thus, when the solenoid valve 26 is opened and the pressure reduction state is released, the seal ring 64 returns to its originalshape by its own elastic force, and the housing 5 is moved in the front end direction (see fig. 9 and 10). At this time, the front end of the flange 56 of the housing 5 contacts the base end of the protrusion 611 of the body portion 61, and excessive movement in the front end direction is restricted (see fig. 10). That is, the housing 5 and the puncture instrument 13 mounted therein return to the position before the puncture instrument retracting mechanism 6 is driven.

Next, the operations of the respective sections and the control operation of the control means in the case of performing puncturing, blood collection and distribution, and blood glucose level measurement with the body fluid component measuring apparatus 1 will be described with reference to the flowchart shown in fig. 2, 5, 7 to 10, 15 to 17, and 20.

First, the puncture instrument 13 is inserted into the fitting portion 53 of the housing 5 through the opening 212 of the frame 21, and the reduced diameter portion 143 of the puncture needle 14 is fitted to the needle holder 411 (see fig. 16).

Subsequently, when the puncture instrument 13 is pushed in the proximal direction, the plunger 41 is moved in the proximal direction against the elastic force of the coil spring 42. The engaging portion 413 is urged by the elastic force of the elastic piece 412 to contact the inner peripheral surface of the cavity portion 52, and is inserted into the opening 57 when the engaging portion 413 is at the position of the opening 57 (see fig. 16). Thus, even when the pressing force in the proximal direction of the puncture instrument 13 is released, the engaging portion 413 engages with the opening 57, and 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, the preparation for puncturing by the puncturing mechanism 4 and the preparation for collecting blood (sample) are finished.

Then, a power switch not shown in the figure is turned on, and each part of the body fluid component measuring apparatus 1 is started to be in a measurable state. In addition, the electromagnetic valve 26 is closed.

Next, the fingertip (finger) 200 is pressed against the stopper 3. Thereby, the fingertip 200 is pressed against the abutting portion 163 of the puncture instrument 13. At this time, the tip opening 162 is closed with the fingertip 200 (see fig. 5) so as to reduce air leakage as much as possible.

Then, the operation button 222 is pressed to drive the body fluid component measuring apparatus 1. Thereby, the routine shown in fig. 20 is implemented.

First, the control unit 11 drives the pump 8 before puncturing, and starts suction of air in the cavity 52 (including the puncture instrument 13) of the housing 5 (step S101 in fig. 20).

Thus, when there is no problem, the pressure in the lumen portion 52 (including the inside of the puncture instrument 13) is reduced to be in a reduced pressure state (see fig. 17). At this time, the puncture site 210 of the needle body 141 of the fingertip 200 is also in a decompressed state. However, in this state, the fingertip 200 positioned inside the abutting portion 163 (the distal end opening 162) bulges into the puncture instrument 13, and is formed into a hill shape, and presses the capillary at the peripheral portion of the puncture site 210 abutting against the distal end of the abutting portion 163.

Next, the pressure in the cavity 52 (including the puncture instrument 13) of the housing 5 is detected by the pressure sensor 27 (step S102 in fig. 20).

Then, the control means 11 determines whether or not the internal cavity 52 (including the puncture instrument 13) is in a reducedpressure state, that is, whether or not the pressure is reduced to a predetermined pressure (pressure OK) set in advance, based on the information from the pressure sensor 27 (step S103 in fig. 20).

In step S103, if it is determined that the pressure OK is not realized, it is determined whether or not the time has elapsed (step S104 in fig. 20).

If it is determined in step S104 that the time has not elapsed, a position correction notification is performed (step S105 in fig. 20).

In step S105, the display unit 12 displays the case where the position of the finger abutting against the finger stopper 3 is to be corrected, or the sound output unit 32 notifies the case of the correction with sound. Of course, this may be performed by both the display unit 12 and the sound output unit 32.

The operator (user) can grasp the situation of the event based on the position correction report, move the finger position to the correct position, reduce air leakage as much as possible, and set the finger posture to the correct posture.

After the execution of step S105, the process returns to step S102, the process from step S102 onward is executed again, and if it is determined in step S104 that the time has elapsed, an error notification is performed (step S106 in fig. 20). Further, the pump 8 is stopped, the electromagnetic valve 26 is opened once, and closed again.

In step S106, for example, the display unit 12 displays the error or the audio output unit 32 notifies the error as an audio. Of course, this may be performed by both the display unit 12 and the sound output unit 32.

The operator (user) can grasp that there is an error (there is any trouble) based on the error notification.

When it is determined that the pressure is OK in step S103, the skin of the fingertip 200 is punctured (step S107 in fig. 20).

In other words, the control mechanism 11 energizes the coil of the solenoid 28. Thereby, the plunger 281 of the solenoid 28 is moved in the direction indicated by the arrow in fig. 16, and comes into contact with the engagement portion 413, thereby pushing back the engagement portion 413 toward the inner cavity portion 52. Thereby, the engagement of the engaging portion 413 is released, and the plunger 41 is moved in the distal direction by the elastic force of the compressed coil spring 42, so that the needle body 141 protrudes from the distal opening 162 and punctures the skin of the fingertip 200 (see fig. 18). Bleeding occurs from the puncture site 210 of the needle body 141.

After the needle body 141 pierces the fingertip 200, the coil spring 43 presses the plunger 41 in the proximal direction. After the damping movement, the plunger 41 is at rest at a position where the elastic force of the coil spring 42 and the elastic force of the coil spring 43 are balanced (see fig. 8). At this time, the blade tip of the needle body 141 is accommodated in the puncture instrument 13. Therefore, the blade edge of the needle body 141 does not protrude from the distal end opening 162 except during puncturing. Can eliminate the phenomenon of skin injury by mistake, and can prevent infection with good safety.

In [ 6], the air in the variable volume chamber 631 gradually flows out to the inner chamber section 52 through the orifice 651 and the volume of the variable volume chamber 631 gradually decreases by continuing the suction of the air in the inner chamber section 52 by the pump 8. Thereby, the housing 5 and the puncture instrument 13 mounted therein start to move gradually in the proximal direction, i.e., in the direction away from the fingertip 200.

At this time, since the decompression state of the inner cavity 52 and the puncture site 210 of the fingertip 200 is continuously maintained, the fingertip 200 does not come loose from the distal end opening 162. Further, even if the puncture instrument 13 moves in a direction away from the fingertip 200, the fingertip 200 contacts the stopper 3, and therefore does not move with the puncture instrument 13. Therefore, the puncture instrument 13 can be reliably separated from the fingertip 200.

When the puncture instrument 13 is separated from the fingertip 200, the capillary vessels in the vicinity of the puncture site 210 pressed by the tip of the abutment portion 163 gradually open, and blood 220 can be aspirated from the puncture site 210 (see fig. 9). In other words, bleeding is promoted and a required amount of blood can be secured in a short time as compared with the case where the fingertip 200 and the puncture instrument 13 are not separated.

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

Next, the base end 591 of the convex portion 59 is in contact with the bottom surface of the concave portion 621. Thereby, the movement of the housing 5 and the puncture instrument 13 contained therein in the proximal direction is stopped. Accordingly, since the puncture instrument 13 can be stopped at a place between appropriate distances from the fingertip 200, the fingertip 200 does not come loose from the front end opening 162. This can more reliably prevent scattering of blood 220 aspirated from puncture site 210 and contamination of the surroundings, and improve safety.

As described above, the body fluid component measuring apparatus 1 can perform the puncturing operation and the pressure reducing operation substantially simultaneously by one-time pressing of the operation button 222, and the retraction operation of the puncture instrument 13 is also performed by the pressure reducing force of the pump 8, and the pressure reducing releasing operation described later can be automatically started, so that the operability is very good.

In the operation [ 6]above, blood 220 that has risen up in the form of particles at the puncture site 210 is sucked into the puncture instrument 13, comes into contact with the blood introduction guide member 166 formed inside thereof, is introduced into the test paper 18 through the blood passage 19, is supplied to the center of the test paper 18, and spreads radially (see fig. 2).

As the blood 220 is supplied to and scattered from the test strip 18, the glucose (component to be measured) in the blood 220 reacts with the reagent held on the test strip 18, and the test strip 18 develops color in accordance with the amount of glucose.

On the other hand, after step S107 shown in fig. 20 is performed, the control means 11 drives the measurement means 7, monitors (monitors) the color development of the test strip 18 by the measurement means 7, and determines whether or not blood is collected (step S108 in fig. 20).

In step S108, it is determined that blood is collected when the voltage value of the signal input from the light-receiving element 72 of the measurement means 7 exceeds a preset limit value, and it is determined that blood is not collected when the voltage value of the signal is lower than the limit value.

The above limit values are set as: the voltage value of the signal before the color development of the test paper 18 is very large and the voltage value of the signal during the color development is very small.

In step S108, if it is determined that blood has not been collected, it is determined whether or not the time has elapsed (stepS109 in fig. 20).

In the above step S104, when it is determined that the time has not elapsed, the process returns to step S108, the process from step S108 is performed again, and when it is determined that the time has elapsed, an error notification is performed (step S110 in fig. 20). Further, the pump 8 is stopped, the electromagnetic valve 26 is opened once, the decompression state is released, and then the electromagnetic valve 26 is closed again.

In step S106, for example, the display unit 12 displays the error or the audio output unit 32 notifies the error as an audio. Of course, this may be performed by both the display unit 12 and the sound output unit 32.

The operator (user) can grasp that there is an error (there is any trouble) based on the error notification.

In addition, when it is determined in step S108 that blood has been collected, the pump 8 is stopped, that is, the suction of air in the inner chamber 52 by the pump 8 is stopped (step S111 in fig. 20).

Subsequently, the solenoid valve 26 is opened to release the pressure reduction state (step S112 in fig. 20).

When the electromagnetic valve 26 is opened, the outside air (atmosphere) flows into the inner cavity 52 (including the puncture device 13) and the puncture site 210 through the tubes 82 and 81 and the ventilation passage 54, and returns the inner cavity 52 (including the puncture device 13) and the puncture site 210 to the atmospheric pressure (see fig. 10).

The seal ring 64 returns to its original shape by its own elastic force, and moves the housing 5 in the front end direction (see fig. 10 and 11). At this time, the distal end of the flange 56 of the housing 5 contacts the proximal end of the projection 611 of the main body 61, and the excessive movement of the housing 5 in the distal direction is restricted (see fig. 11).

If it is confirmed that the suction feeling of the peripheral portion of the puncture site 210 of the fingertip 200 has been eliminated and returned to the atmospheric pressure, the fingertip 200 is moved away from the abutment 163 of the puncture instrument 13.

After step S112 shown in fig. 20 is performed, the control means 11 measures the degree of color development of the test strip 18 by the measuring means 7, and performs correction such as calculation processing, temperature correction calculation, and hematocrit value correction calculation based on the obtained data to quantify the blood glucose level (step S113 in fig. 20).

In this case, since the reduced pressure state of the inner chamber 52 (including the puncture device 13), that is, the reduced pressure state of the housing space of the test strip 18 is released, components in the atmosphere (for example, oxygen, carbon dioxide, water vapor, and the like) necessary for the reaction between the glucose (component to be measured) in the blood 220 and the reagent held on the test strip 18 can be sufficiently supplied, and thus the blood glucose level can be measured more accurately.

Next, the calculated blood glucose level is displayed on the display unit 12 (step S114 in fig. 20).

This makes it possible to grasp the blood glucose level.

In step S112, after the decompression state is released, the solenoid valve 26 is closed again in preparation for the next measurement.

As described above, according to the body fluid component measuring apparatus 1, a sufficient amount of blood necessary for measurement can be collected reliably in a short time, and the blood glucose level (the amount of a predetermined component in the blood) can be measured accurately and reliably.

Further, since the puncture mechanism 4 is driven to puncture only when the pressure reduction is attempted and the reduced pressure state is confirmed before puncturing, the occurrence of redundant puncturing of the finger can be prevented, and the burden on the patient can be reduced.

Further, since the puncture instrument 13 is provided with the test paper 18, puncture, collection of blood, and scattering and measurement (quantification of components) on the test paper 18 can be performed continuously, and thus, measurement of blood glucose level (component measurement) can be easily performed in a short time.

Further, since the preparation operation at the time of use is easy, it is also advantageous for the case of regular use or the case of repeated use.

The safety is improved by preventing an accident such as erroneous re-piercing of the living body surface after the piercing. Further, since the puncture needle 14 is not directly visible, the fear of puncture is also reduced.

As can be seen from the above, the body fluid component measuring apparatus 1 is suitable for use in a case where a patient measures his/her own blood glucose level or the like.

In addition, the body fluid component measuring apparatus 1 is simple in structure, small in size, light in weight, and inexpensive, and therefore is also suitable for mass production.

Next, a second embodiment of the body fluid component measuring device according to the second aspect of the present invention will be described.

FIG. 21 is a block diagram showing a control operation of the control means of the body fluid component measuring apparatus according to the second embodiment of the present invention. The description of the points common to the body fluid component measuring device of the first embodiment is omitted, and only the main points of difference will be described.

The configuration of the body fluid component measurement device 1 according to the second embodiment is the same as that of the body fluid component measurement device 1 according to the first embodiment, and therefore, the description thereof is omitted, and here, the operation thereof will be described centering on the difference from the body fluid component measurement device 1 according to the first embodiment based on the flowchart shown in fig. 21.

In this body fluid component measurement device 1, when the operation button 222 is pressed, the routine shown in fig. 21 is executed.

First, before puncturing, the control unit 11 drives the pump 8 to start suction of air in the cavity 52 (including the puncture instrument 13) of the housing 5 (step S201 in fig. 21).

Next, the pressure in the cavity 52 (including the puncture instrument 13) of the housing 5 is detected by the pressure sensor 27 (step S202 in fig. 21).

Then, the control means 11 determines whether or not the internal cavity 52 (including the puncture instrument 13) is in a reduced pressure state, that is, whether or not the pressure is reduced to a predetermined pressure (pressure OK) set in advance, based on the information from the pressure sensor 27 (step S203 in fig. 21).

If it is determined in step S203 that the pressure OK is not achieved, an error notification is performed (step S204 in fig. 21), and the pump 8 is stopped, the electromagnetic valve 26 is opened once, and closed again.

In step S204, the display unit 12 displays the error or the audio output unit 32 notifies the error as audio. Of course, this may be performed by both the display unit 12 and the sound output unit 32.

The operator (user) can grasp that there is an error (there is any trouble) based on the error notification.

If it is determined in step S203 that the pressure is OK, the epidermis of the fingertip 200 is punctured (step S205 in fig. 21).

Next, the control means 11 drives the measurement means 7, and the measurement means 7 monitors (monitors) the color development of the test strip 18 to determine whether or not blood is collected (step S206 in fig. 21).

In step S206, if it is determined that blood has not been collected, it is determined whether or not the time has elapsed (step S207 in fig. 21).

In step S207, if it is determined that the time has not elapsed, the process returns to step S206, the process from step S206 is performed again, and if it is determined that the time has elapsed, an error notification is performed (step S208 in fig. 21). Further, the pump 8 is stopped, the electromagnetic valve 26 is opened once, the decompression state is released, and then the electromagnetic valve 26 is closed again.

In step S208, for example, the display unit 12 displays the error or the audio output unit 32 notifies the error as an audio. Of course, this may be performed by both the display unit 12 and the sound output unit 32.

The operator (user) can grasp that there is an error (there is any trouble) based on the error notification.

In addition, when it is determined in step S206 that blood has been collected, the pump 8 is stopped, that is, the suction of air in the inner chamber 52 by the pump 8 is stopped (step S209 in fig. 21).

Subsequently, the electromagnetic valve 26 is opened to release the pressure reduction state (step S210 in fig. 21).

Subsequently, the measurement means 7 measures the degree of color development of the test strip 18, and corrects the data by performing calculation, temperature correction calculation, hematocrit value correction calculation, and the like to quantify the blood glucose level (step S211 in fig. 21).

Next, the calculated blood glucose level is displayed on the display unit 12 (step S212 in fig. 21).

This makes it possible to grasp the blood glucose level.

In step S210, after the decompression state is released, the solenoid valve 26 is closed again in preparation for the next measurement.

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

Next, a third embodiment of the body fluid component measuring device according to the second aspect of the present invention will be described.

FIG. 22 is a block diagram showing a control operation of a control means in the third embodiment of the body fluid component measuring apparatus according to the present invention. The description of the points common to the body fluid component measuring device 1 of the first embodiment is omitted, and only the main points of difference will be described.

The configuration of the body fluid component measurement device 1 according to the third embodiment is the same as that of the body fluid component measurement device 1 according to the first embodiment, and therefore, the description thereof is omitted, and here, the operation thereof will be described centering on the difference from the body fluid component measurement device 1according to the first embodiment based on the flowchart shown in fig. 22.

In the body fluid component measurement device 1, when the operation button 222 is pressed, the routine shown in fig. 22 is executed.

First, before puncturing, the control unit 11 drives the pump 8 to start suction of air in the cavity 52 (including the puncture instrument 13) of the housing 5 (step S301 in fig. 22).

Next, the pressure in the cavity 52 (including the puncture instrument 13) of the housing 5 is detected by the pressure sensor 27 (step S302 in fig. 22).

Then, the control means 11 determines whether or not the internal cavity 52 (including the puncture instrument 13) is in a reduced pressure state, that is, whether or not the pressure is reduced to a predetermined pressure (pressure OK) set in advance, based on the information from the pressure sensor 27 (step S303 in fig. 22).

In step S303, if it is determined that the pressure OK is not realized, it is determined whether or not the time has elapsed (step S304 in fig. 22).

If it is determined in step S303 that the time has not elapsed, a position correction notification is performed (step S305 in fig. 22).

In step S305, the display unit 12 displays the case where the position of the finger abutting against the finger stopper 3 is to be corrected, or the sound output unit 32 notifies the case of the correction with sound. Of course, this may be performed by both the display unit 12 and the sound output unit 32.

The operator (user) can grasp the situation of the event based on the position correction report, move the finger position to the correct position, reduce air leakage as much as possible, and set the finger posture to the correct posture.

After the above step S305 is performed, the process returns to the step S302, the process from the step S302 is performed again, and when it is determined that the time has elapsed in the above step S304, an error notification is performed (step S306 in fig. 22). Further, the pump 8 is stopped, the electromagnetic valve 26 is opened once, and closed again.

In step S306, the display unit 12 displays the error or the audio output unit 32 notifies the error with audio. Of course, this may be performed by both the display unit 12 and the sound output unit 32.

The operator (user) can grasp that there is an error (there is any trouble) based on the error notification.

When it is determined that the pressure is OK in step S303, the pump 8 is stopped, that is, the suction of the air in the inner chamber 52 by the pump 8 is stopped (step S307 in fig. 22).

Next, when the solenoid valve 26 is opened, the pressure-reduced state is released (step S308 in fig. 22). In step S308, after the decompression state is released, the electromagnetic valve 26 is closed again.

Next, the skin of the fingertip 200 is punctured (step S309 in fig. 22).

Subsequently, the pump 8 is driven to start sucking air in the cavity 52 (including the puncture instrument 13) of the housing 5 (step S310 in fig. 22).

Next, the control means 11 drives the measurement means 7, and the measurement means 7 monitors (monitors) the color development of the test strip 18 to determine whether or not blood is collected (step S311 in fig. 22).

In step S311, if it is determined that blood has not been collected, it is determined whether or not the time has elapsed (step S312 in fig. 22).

In the above step S312, when it is determined that the time has not elapsed, the process returns to step S311, the process from step S311 is performed again, and when it is determined that the time has elapsed, an error notification is performed (step S313 in fig. 22). Further, the pump 8 is stopped, the electromagnetic valve 26 is opened once, the decompression state is released, and then the electromagnetic valve 26 is closed again.

In step S313, for example, the display unit 12 displays the error or the audio output unit 32 notifies the error as an audio. Of course, this may be performed by both the display unit 12 and the sound output unit 32.

The operator (user) can grasp that there is an error (there is any trouble) based on the error notification.

In addition, when it is determined in step S311 that blood has been collected, the pump 8 is stopped, that is, the suction of air in the inner chamber 52 by the pump 8 is stopped (step S314 in fig. 22).

Subsequently, the solenoid valve 26 is opened to release the pressure reduction state (step S315 in fig. 22).

Subsequently, the measurement means 7 measures the degree of color development of the test strip 18, and corrects the data by performing calculation, temperature correction calculation, hematocrit value correction calculation, and the like to quantify the blood glucose level (step S316 in fig. 22).

Next, the calculated blood glucose level is displayed on the display unit 12 (step S317 in fig. 22).

This makes it possible to grasp the blood glucose level.

In step S315, after the decompression state is released, the solenoid valve 26 is closed again in preparation for the next measurement.

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

Further, according to the body fluid component measuring apparatus 1, when the reduced pressure state is detected, the reduced pressure state is temporarily released and then the puncture is performed, and thus, the change in the amount of the skin swollen by the pressure due to the large hardness of the skin at the fingertip depending on the person can be reduced, and therefore, the puncture can be performed with higher accuracy in terms of the puncture depth.

In the present invention, for example, the above-described steps S304 and S305 may be omitted.

Next, a fourth embodiment of the second aspect of the present invention will be described with reference to fig. 13.

The body fluid component measurement device 1 of the fourth embodiment is the same as the body fluid component measurement devices 1 of the first to third embodiments except that the configuration of the decompression release mechanism is different from that of the body fluid component measurement devices 1 of the first to third embodiments, and the description thereof will not be repeated here.

In other words, as shown in fig. 13, the body fluid component measuring device 1 is provided with a narrow tube 83 instead of the electromagnetic valve 26 of the body fluid component measuring device 1 according to the first to third embodiments.

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

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

The pipes (flow paths) 81 and 82 and the narrow pipe 83 constitute a decompression release mechanism.

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

In this body fluid component measuring apparatus 1, since the flow rate of air sucked by driving the pump 8 is larger (more) than the flow rate of outside air (atmospheric air) flowing in from the orifice 831 of the narrow tube 83, the air in the cavity portion 52 of the housing 5 is sucked when the pump 8 is driven, whereby the pressure in the cavity portion 52 (including the inside of the puncture instrument 13) is reduced and the pressure is reduced.

When the pump 8 is stopped, the outside air flows into the lumen portion 52 (including the puncture instrument 13) and the puncture site 210 through the orifice 831 of the narrow tube 83, the tubes 82 and 81, and the ventilation passage 54, and the reduced pressure state of the lumen portion 52 (including the puncture instrument 13) and the puncture site 210 is released. In other words, the cavity 52 (including the puncture instrument 13) and the puncture site 210 are returned to the atmospheric pressure.

According to this body fluid component measurement device 1, the same effects as those of the body fluid component measurement device 1 of the firstto third embodiments can be obtained.

Although the body fluid component measuring device according to the second aspect of the present invention has been described above with reference to the illustrated embodiments, the present invention is not limited thereto. For example, the structure of each part may be replaced with any structure that can exhibit the same function.

In the above embodiment, blood was described as a representative of the collected body fluid, but in the present invention, the collected body fluid is not limited to this, and may be sweat, lymph, or marrow fluid, for example.

In the above-described embodiment, the component to be measured is exemplified by glucose (blood glucose level), but the present invention is not limited to this in terms of the component to be measured, and may be, for example, protein, cholesterol, uric acid, creatine amide, inorganic ions such as ethanol and sodium.

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, or may measure the amount and the property of the predetermined component.

In the present invention, the suction force of the pump 8, that is, the pressure in the accommodating space (the lumen portion 52) of the puncture needle at the time of blood collection may be a constant pressure or may be a pressure that changes (changes with time).

Fig. 23 and 24 show the pressure pattern in the accommodating space (the cavity portion 52) of the puncture needle at the time of blood collection.

In the present invention, for example, as shown in fig. 23, the pressure in the housing space (the lumen portion 52) of the puncture needle may be alternately switched between low pressure and high pressure, and as shown in fig. 24, the pressure in the housing space (the lumen portion 52) of the puncture needle may be gradually increased. In this case, the timing of puncturing is not particularly limited.

By changing the pressure in the accommodation space (the lumen portion 52), a sufficient amount of blood required for measurement can be reliably collected in a shorter time.

In the above embodiment, the pressure detection means uses the pressure sensor, but the present invention is not limited to this, and other sensors such as a position sensor may be used.

When a position sensor is used as the pressure detection means, for example, a mark is provided in advance on the housing 5, a position sensor such as a photo-interrupter is provided on the housing 21 of the main body 2, and the pressure is detected by the position sensor when the housing 5 is introduced into the puncture instrument retraction mechanism 6 by a change in pressure.

In the above embodiment, the blood collection and detection means for detecting the collection of blood and the means for measuring the amount of the predetermined component in blood are provided in combination (in the embodiment, this means is referred to as "measuring means"), but the blood collection and detection means and the measuring means may be provided separately in the present invention.

In the above embodiment, as the blood collection detection means, a means for optically detecting the collection of blood is used, but the present invention is not limited thereto, and other means for electrically detecting, for example, may be used.

In the present invention, when a blood collection and detection mechanism that optically detects collection of blood is used, the detection is not limited to color development (color development) of a test strip that detects a reaction between a component in blood and a reagent, and other cases, such as introduction of blood into a blood passage (blood channel) that supplies blood to a test strip of a puncture device, may be detected.

In the case of detecting the introduction of blood into the blood passage, for example, a configuration may be adopted in which at least a portion near the blood passage in the puncture instrument is formed by a member having translucency (transparency), light is irradiated to the blood passage via a blood collection and detection means, reflected light or transmitted light is received, photoelectric conversion is performed, and the voltage output by the blood collection and detection means is monitored via a control means. When blood is introduced into the blood passage, the color of the portion changes to substantially red-black, and therefore the amount of reflected light or transmitted light from the portion changes, the voltage output from the blood collection detection means changes, and blood collection can be detected by detecting the change in the output voltage (amount of light).

As the blood collection detection means for electrically detecting the blood collection, for example, a sensor (electrode) for detecting (measuring) the impedance of the blood path of the puncture device or the like, a biosensor, or the like can be used.

In the case of using the biosensor, for example, when blood is introduced into the blood channel, the current output from the biosensor changes, and therefore detection of the change in the output current (current value) enables detection of blood collection.

In addition, in the case of using a sensor for detecting the impedance, for example, when blood is introduced into the blood passage, the impedance between the sensor electrodes changes, and therefore, the detection of the change in the impedance enables detection of blood collection.

The body fluid component measuring apparatus of the present invention optically measures (measures) the intensity of color development of the developed test strip by the reaction between the component in blood and the reagent, and converts and displays the intensity of color development into a measured value.

In the above embodiment, the reduced pressure state is released before the measurement, but in the present invention, a structure in which the reduced pressure state is relaxed before the measurement may be adopted.

In the present invention, the driving of the decompression mechanism and the puncture instrument retraction mechanism may be started manually or automatically.

Next, a body fluid component measuring device according to a third embodiment of the present invention will be described in detail based on preferred embodiments shown in the drawings.

In the following description, the same drawings as those of the first embodiment described above with reference to fig. 2 and 9 will be applied.

Fig. 25 is a perspective view schematically showing a first embodiment of a body fluid component measuring device according to a third embodiment (hereinafter, the term "third embodiment" is omitted) corresponding to fig. 1 of the first embodiment. Fig. 26 to 27 are vertical sectional views showing an example of the puncture mechanism and a housing incorporating the puncture mechanism, and are drawings corresponding to fig. 3 and 4 except that the puncture instrument retracting mechanism 61 is replaced with a supporting portion 600. Fig. 28 to 31 are vertical sectional views showing an example of the configuration of the main part of the body fluid component measuring device according to the first embodiment, and are drawings corresponding to fig. 5, 6, 8 and 10, respectively, except that the puncture instrument retracting mechanism 61 is replaced with a supporting part 600.

FIG. 32 is a block diagram showing a control operation of a control means of the body fluid component measuring apparatus according to the first embodiment. In this figure, the same reference numerals as in the above-described figures denote the same or corresponding parts.

In these drawings, the right side of the drawing is referred to as the "base end" and the left side is referred to as the "tip end".

As shown in fig. 25, 28, and 9, a body fluid component measurement device (blood component measurement device) 1 according to a first embodiment includes: a body 2; a stopper portion 3 provided on the body 2; a puncture mechanism 4 housed in the housing 5; a puncture instrument retracting mechanism 6 provided on the proximal end side of the housing 5; a 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 inside the casing 5; a solenoid valve 26 for releasing, relaxing, or maintaining the pressure-reduced state in the case 5; a pressure sensor (pressure detection means) 27 that detects the pressure in the housing 5; a solenoid (drive source) 28; a switch 29; a battery (power supply) 9; a control mechanism 11 and a memory 33 provided on the printed circuit board 10; a display unit (notification means) 12; an audio output unit (notification means) 32; and an external output unit 34.

The body fluid component measuring apparatus 1 is used after being attached with the puncture device 13. The following describes each constituent element.

The main body 2 is composed of a frame 21 and a lid 22 facing each other. The main body 2 has a housing space 23 formed therein, and the puncture mechanism 4, the case 5, the measurement mechanism 7, the pump 8, the electromagnetic valve 26, the solenoid 28, the switch 29, the battery 9, the printed circuit board 10, the control mechanism 11, the memory 33, the display unit 12, the audio output unit 32, and the external output unit 34 are mounted in the housing space 23. In addition, a pressure sensor 27 is provided in the housing 5.

An opening 212 having a circular cross-sectional shape is formed through the inside and outside of the frame 21 in the wall portion 211 on the front end side of the frame 21. The puncture instrument 13 described later is attached (held) to the housing 5 through the opening 212.

Further, on the surface of the wall portion 211 on the front end side, around the outer periphery of the opening 212, a finger stopper (stopper against which the skin comes into contact) 3 formed in correspondence with the shape of a fingertip (finger) is provided. A finger stopper surface 31 is formed on the front end side of the stopper portion 3. The fingertip comes into contact with the finger stopper 3 (finger stopper surface 31) to drive the body fluid component measurement device 1. With this, the fingertip is punctured, and the amount of a predetermined component (hereinafter, in the present embodiment, glucose is described as a representative) in the collected blood is measured.

A display window (opening) 221 is formed on the upper surface of the cover 22 so as to penetrate the inside and outside of the cover 22, and the display window is covered with a plate-like member made of a transparent material.

A display unit 12 is provided at a position in the housing space 23 corresponding to the display window 221. Therefore, various information displayed by the display unit 12 can be confirmed through the display window 221.

The display unit 12 is formed of, for example, a liquid crystal display element (LCD). The display unit 12 can display, for example, on/off of a power supply, a power supply voltage (remaining battery level), a measurement value, a measurement date, an error display, a position correction display, an operation guide, and the like.

The sound output unit 32 is constituted by, for example, a buzzer (a device that generates a predetermined sound or melody), a sound emitting device, and the like.

The notification means is not limited to the above configuration, and may be other light emitting elements such as a Light Emitting Diode (LED) and an EL element, a lamp, an EL display element, and the like.

The external output unit 34 outputs the data of the obtained blood glucose level and the like to an external device such as a personal computer.

An operation button 222 is provided on the upper surface of the cover 22. The body fluid component measuring apparatus 1 is configured such that the switch 29, which is interlocked with the operation button 222, is turned on by pressing the operation button 222, and the signal is input from the switch 29 to the control means 11.

A printed circuit board 10 is provided on the lower side of the display unit 12 in fig. 25, and a control unit 11 formed of a microcomputer and a memory 33 are mounted on the printed circuit board 10. The control means 11 controls various operations of the liquid component measurement device 1, for example, determination of whether or not blood is collected. The control means 11 incorporates a checking unit that calculates the amount of glucose (blood glucose level) in the blood based on the signal from the measurement means 7.

A pump 8 as a pressure reducing mechanism (suction mechanism) is provided on the lower left side of the printed circuit board 10 in fig. 25. The pump 8 is electrically driven and is connected to a pipe 81 through a ventilation passage 54 formed in a housing 5 described later. The pipe 81 has flexibility and is made of a polymer material such as polyolefin, e.g., polyvinyl chloride, polyethylene, polypropylene, ethylene-vinyl acetate copolymer (EVA), polyamide, polyester, silicone rubber, polyurethane, or the like.

The pump 8 sucks and discharges air in the cavity 52 of the housing 5, thereby bringing the cavity 52 of the housing 5 into a pressure-reduced state.

The pump 8 may reduce the pressure in the inner cavity 52 of the housing 5 and the finger puncture site to such a level that blood is sucked from the finger puncture site (for example, to a level of 100 to 600 mmHg).

On the lower right side in fig. 25 of the printed circuit board 10, a battery 9 as a power source is provided. The battery 9 is electrically connected to the pump 8, the solenoid valve 26, the solenoid 28, the control mechanism 11, the display unit 12, the audio output unit 32, and the like, and supplies electric power necessary for driving these components.

A measurement unit 7 is disposed immediately before the pump 8 in fig. 25. The measuring means 7 optically detects the supply (collection) of blood to the test strip 18 provided with the puncture instrument 13 described later, and optically measures the amount of glucose in the blood scattered on the test strip 18 at a position near the position side of the test strip 18 in a state where the puncture instrument 13 is attached to and held in the case 5.

Accordingly, since the measurement means 7 has both a function of detecting the collection of blood and a function of measuring the amount of glucose (predetermined component) in blood scattered on the test strip 18, the number of parts can be reduced, the configuration can be simplified, and the number of assembly steps of the apparatus can be reduced as compared with a case where such means is provided at each position.

The measurement unit 7 includes 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 through the amplifier 24 and the a/D converter 25.

The light emitting element 71 is driven by a signal from the control means 11 to emit light. The light is preferably pulsed light that intermittently emits light at given time intervals.

When the light emitting element 71 is caused to emit light in a state where the puncture instrument 13 is mounted in the housing 5, the test paper 18 is irradiated with light emitted from the light emitting element 71, the reflected light is received by the light receiving element 72, photoelectrically changed, an analog signal corresponding to the amount of light received is output from the light receiving element 72, amplified by the amplifier 24 to a desired signal, converted into a digital signal by the a/D converter 25, and input to the control mechanism 11.

The control means 11 determines whether or not blood is collected based on the input signal, that is, whether or not blood is scattered on the test paper 18 of the puncture instrument 13.

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

A housing 5 having the puncture mechanism 4 built therein is provided directly in front of the measurement mechanism 7 in fig. 25.

As described above, the body fluid component measurement device 1 is used by mounting the puncture instrument 13 in the housing 5. As shown in fig. 2, the puncture device 13 includes a puncture needle 14, a first case 15 that slidably accommodates the puncture needle 14, a second case 16 provided on an outer peripheral portion of the first case 15, a strip fixing portion 17 provided on an outer peripheral portion of the second case 16, and a strip 18 fixed to the strip fixing portion 17.

The puncture needle 14 is composed of a needle body 141 and a shank 142 fixed to the proximal end side of the needle body 141, and is accommodated in the cavity portion 152 of the first casing 15.

The needle body 141 is made of a hollow member or a solid member made of a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, a titanium alloy, or the like, and a sharp blade tip (needle point) is formed at the front end thereof to pierce the epidermis (skin) of a fingertip.

The stem 142 is substantially composed of a columnar member, and an outer peripheral portion thereof slides in contact with an inner peripheral surface of the first housing 15.

A reduced diameter portion 143 having a reduced diameter is formed at the proximal end portion of the stem 142. The reduced diameter portion 143 is fitted to a needle holder 411 of the plunger 41 constituting the puncture mechanism 4 described later.

The first casing 15 is formed of a bottomed cylindrical member having a bottom portion formed by a wall portion 153, and an inner cavity portion 152 is formed inside thereof.

A hole 154 having a circular cross-sectional shape is formed in a substantially central portion of the wall portion 153. The needle body 141 passes through the hole 154 when piercing the epidermis of the fingertip (finger). Further, the hole 154 is set to have a hole diameter smaller than the outer diameter of the front end of the shank 142. Therefore, when the puncture needle 14 is moved in the distal end direction of the inner chamber section 152 and the distal end of the shank 142 is brought into contact with the proximal end of the wall section 153, the puncture needle 14 can be prevented from being excessively moved in the distal end direction. Therefore, when the needle body 141 pierces a fingertip, the length of projection from the distal end of the puncture instrument 13 is kept constant. Therefore, the cutting edge of the needle body 141 can be reliably prevented from puncturing too deeply and excessively.

Further, a mechanism for adjusting the distance of movement of the plunger 41 described later is provided, whereby the depth of penetration of the tip of the needle body 141 into the fingertip can be adjusted.

A second casing 16 is fixed to an outer peripheral portion of the first casing 15.

The second housing 16 is formed of a substantially cylindrical member, and an inner cavity 161 is formed therein.

An abutting portion 163 protruding in an annular shape is formed at the front end of the second housing 16. The abutting portion 163 is a portion against which the tip is pressed, and a front end opening (opening) 162 that opens the cavity 161 is formed inside thereof. The outer peripheral edge of the tip of the abutting portion 163 is shaped such that: is suitable for alleviating the stimulation around the puncture and the pain during the puncture when the fingertip is pressed against the puncture pad; in addition, the shape is also made as follows: when the pressure is reduced by the pump 8, the inflow of air from between the tip of the abutting portion 163 and the surface of the fingertip can be suppressed as much as possible. The front end surface of the second casing 16 may be a flat surface without providing the abutting portion 163 at the front end of the second casing 16.

An annular flange 164 protruding outward is formed on the outer peripheral portion of the second housing 16 near the base end of the abutment portion 163. In a state where the annular flange 164 is attached to a housing 5 described later, a base end thereof is in contact with a front end of the housing 5, and defines a position relative to the housing 5.

A recess 165 is formed in the outer periphery of the second housing 16, and a strip fixing portion 17 for mounting a disk-shaped strip 18 is attached to the recess 165.

Further, a blood introduction guide member 166 protruding into the inner chamber 161 is formed on the inner peripheral surface of the second housing 16. The blood introduction guide member 166 has a function of receiving blood (specimen) that has flowed into the lumen 161 from the distal end opening 162 after puncturing the fingertip.

In the puncture instrument 13, a blood passage 19 is formed to communicate the inner cavity 161 of the second case 16 with the outside via the second case 16 and the strip fixing portion 17. The blood passage 19 is a channel for guiding the punctured blood to the test paper 18, and has a passage opening 191 that opens to the inner chamber 161 and a passage opening 192 that opens to the outside of the puncture instrument 13. In addition, the passage opening 192 is located at the center of the test paper 18.

Blood introduction guide member 166 is formed near passage opening 191. Therefore, the blood received by the blood introduction guide member 166 is more efficiently guided from the passage opening 191 to the blood passage 19. The blood reaches the passage opening 192 by capillary action, and is supplied to the center portion of the test paper 18 provided so as to close the passage opening 192, and is scattered radially.

The test strip 18 is a carrier that absorbs and disperses blood and holds a reagent. The support may be a sheet-like porous body such as a nonwoven fabric, a woven fabric, or a stretched sheet. The porous body is preferably hydrophilic.

The reagent held on the carrier can be appropriately determined depending on the component to be measured in blood (specimen). For example, in the case of measuring blood glucose level, for example, Glucose Oxidase (GOD), Peroxidase (POD), and a color-developing agent (color-developing reagent) such as 4-aminoantipyrine and N-ethyl-N- (2-hydroxy-3-sulfopropyl) -m-toluidine may be used, and in addition, for example, a color-developing agent (color-developing reagent) that reacts with blood components such as ascorbate oxidase, alcohol oxidase, and cholesterol oxidase and the like may be used depending on the measurement component. In addition, a demulcent such as a phosphate buffer may be included. It goes without saying that the kind and components of the reagent are not limited thereto.

The puncture instrument 13 is detachably attached (fitted) to the housing 5 (fitting portion 53) through the opening 212 of the frame 21.

As shown in fig. 25, 26, and 27, a bottomed cylindrical support portion 600 is fixed to the base end side of the frame body 21. The base end portion of the housing 5 is fitted to the support portion 600.

As shown in fig. 26 and 27, the case 5 is formed of a bottomed cylindrical member having a wall portion 51 as a bottom portion, and an inner cavity portion (housing space) 52 is formed inside thereof. Further, a fitting portion 53 whose inner diameter is reduced in diameter in accordance with the outer peripheral shape of the puncture instrument 13 is formed on the distal end side of the housing 5. The puncture instrument 13 is inserted into the fitting portion 53 and fitted (fixed) thereto. In fig. 26 and 27, the configuration of the puncture instrument 13 is shown in a simplified manner for the sake of easy understanding of the explanation.

A ventilation passage 54 is formed in a side portion of the housing 5 to communicate the inner chamber 52 with the outside. The vent passage 54 is connected to the pump 8 through a pipe 81. The air in the lumen portion 52 is sucked by the pump 81 through the ventilation passage 54 and the tube 81, and the lumen portion 52 (including the puncture instrument 13) is brought into a reduced pressure state.

As shown in fig. 28, one end of the pipe 82 is connected to the middle of the pipe 81, and the other end of the pipe 82 is open to the outside of the main body 2. The tube 82 is flexible and is 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 pipe 82.

When the electromagnetic valve 26 is closed (in a closed state), the reduced pressure state of the inner chamber 52 (including the puncture instrument 13) is maintained, and when the electromagnetic valve 26 is opened (in an open state), air (atmosphere) is introduced from the outside into the inner chamber 52 in the reduced pressure state through the tubes 82 and 81 and the ventilation passage 54, and the reduced pressure state is released or relaxed.

Therefore, the pressure reduction release mechanism is constituted by the pipes (flow paths) 81 and 82 and the electromagnetic valve 26.

The decompression release mechanism and the pump 8 constitute a pressure adjustment mechanism for adjusting the pressure in the inner chamber 52 (including the puncture instrument 13).

An annular seal ring (seal member) 55 is fitted to the front end of the housing 5. Therefore, when the puncture instrument 13 is mounted in the housing 5, the proximal end of the flange 164 of the puncture instrument 13 contacts the seal ring 55, and the airtightness of the inner cavity 52 is maintained.

The seal ring 55 is made of an elastomer. Examples of the elastomer include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, styrene butadiene rubber, acrylonitrile butadiene rubber, chloroprene rubber, isobutylene rubber, acrylic rubber, ethylene-propylene rubber, chlorothalonil rubber, urethane rubber, silicone rubber, and fluororubber, and various thermoplastic elastomers such as styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, and fluororubber.

The puncture mechanism 4 is accommodated in the cavity 52 on the proximal end side from the fitting portion 53 of the housing 5. The puncture mechanism 4 moves the puncture needle 14 attached thereto in the distal direction, and punctures the surface of the fingertip by the blade tip of the needle body 141.

The puncture mechanism 4 includes a plunger 41, a coil spring (urging member) 42 that urges the plunger 41 in the distal direction, and a coil spring (urging member) 43 that urges the plunger 41 in the proximal direction.

A cup-shaped needle holder 411 is provided at the tip end of the plunger 41. The reduced diameter portion 143 of the puncture needle 14 is detachably fitted to the needle holder 411. Further, an elastically deformable elastic piece 412 is provided at the base end portion of the plunger 41, and a convex engaging portion 413 is provided at the tip end of the elastic piece 412.

In a state before the puncture instrument 13 is mounted to the housing 5, that is, in a state before the puncture needle 14 is mounted to the plunger 41 (see fig. 26), the engaging portion 413 is urged upward in fig. 26 by the elastic force of the elastic piece 412 to contact the inner peripheral surface of the housing 5. On the other hand, in a state in which the puncture instrument 13 is mounted to the housing 5, that is, in a state in which the puncture needle 14 is mounted to the plunger 41 (see fig. 27), the engagement portion 413 is inserted into an opening 57 formed through the inside and outside of the housing 5 and engaged with an edge portion thereof. Thereby, the plunger 41 is restricted from moving in the front direction. The opening 57 is sealed by a flat plate-like sealing member (sealing member) 58, and the airtightness of the inner cavity 52 is maintained. The seal member 58 is made of the same material as the seal ring 55.

A coil spring (puncture spring) 42 is provided on the proximal end side of the plunger 41, and both ends thereof are in contact with the plunger 41 and the wall 51, respectively. On the other hand, a coil spring (return spring) 43 is provided on the tip side of the plunger 41, and both ends thereof are in contact with the plunger 41 and the fitting portion 53, respectively.

Further, a pressure sensor 27 is provided in the housing 5, and the pressure in the cavity 52 (including the puncture instrument 13) of the housing 5 is detected by the pressure sensor 27. Information from the pressure sensor 27, that is, pressure (data) detected by the pressure sensor 27 is input to the control means 11.

As shown in fig. 26 and 27, a solenoid 28 is provided outside the housing 5 as a drivingsource for electric driving. The solenoid 28 is configured to: the plunger 281 can move the engaging portion 413 into the inner cavity 52 (in the direction of the arrow in the figure).

In a state where the engaging portion 413 is engaged with the opening 57, the coil spring 42 is in a compressed state, and biases the plunger 41 in the front end direction. When the plunger 281 of the solenoid 28 moves in a direction indicated by an arrow in the figure and the engagement of the engaging portion 413 is released by the plunger 281, the coil spring 42 expands to move the plunger 41 in the tip direction, and the tip of the needle body 141 punctures the surface (skin) of a fingertip. Therefore, the solenoid 28 constitutes a drive start mechanism for starting the driving of the puncture mechanism 4.

On the other hand, at this time, the coil spring 43 is compressed to urge the plunger 41 in the proximal direction, that is, to press the plunger 41 in the proximal direction. Thereafter, the plunger 41 performs damping movement and is stationary at a position where the elastic force of the coil spring 42 and the elastic force of the coil spring 43 are balanced.

In a state where the plunger 41 is stationary, the blade edge of the needle body 141 is placed in the puncture instrument 13.

In addition, in this body fluid component measurement device 1, when the puncture instrument 13 is inserted into the fitting portion 53 of the housing 5 and the reduced diameter portion 143 of the puncture needle 14 is fitted to the needle holder 411, the tip of the abutment portion 163 is located at substantially the same position as the finger stopper surface 31 or slightly protrudes from the finger stopper surface 31 (see fig. 27 and 28). Thereby, when the fingertip 200 contacts the stopper portion 3, the surface of the fingertip 200 can reliably contact the abutting portion 163, and the front end opening 162 is closed.

In the body fluid component measuring apparatus 1 described above, when blood is collected from the puncture site, the drive of the pump 8 and the electromagnetic valve 26 is controlled based on the information from the pressure sensor 27, and the pressure in the inner cavity 52 (including the puncture instrument 13) is reduced, so that the pressure varies (changes) with time.

The pressure pattern in the lumen portion 52 when the blood is collected includes a decompression time, and the pressure may vary with time, but is not particularly limited. An example thereof is explained below.

Fig. 33 is a graph showing a pressure pattern in the lumen portion 52 at the time of blood collection.

As shown in the drawing, when blood is collected by the body fluid component measurement device 1, the drive of the pump 8 and the electromagnetic valve 26 is controlled to alternately switch the pressure in the lumen portion 52 between a first pressure P1 lower than the atmospheric pressure and a second pressure P2 higher than the first pressure P1.

This makes it possible to reliably collect a sufficient amount of blood required for measurement in a shorter time.

The second pressure P2 may be about the same as or less than atmospheric pressure.

Therefore, a sufficient amount of blood necessary for measurement can be collected more reliably in a shorter time.

The first pressure P1 is preferably about 100 to 600mmHg, more preferably about 400 to 600 mmHg.

Therefore, a sufficient amount of blood necessary for measurement can be collected more reliably in a shorter time.

The difference between the second pressure P2 and the first pressure P1 is preferably about 100 to 600mmHg, more preferably about 300 to 600 mmHg.

Therefore, a sufficient amount of blood necessary for measurement can be collected more reliably in a shorter time.

The period T of the pressure fluctuation is preferably about 1 to 30sec, more preferably about 1 to 5 sec.

Therefore, a sufficient amount of blood necessary for measurement can be collected more reliably in a shorter time.

In the present invention, the waveforms shown in fig. 33 may be substantially equal in shape, or may be partially or entirely different in shape.

Next, the operations of the respective sections and the control operation of the control means in the case of performing puncturing, blood collection, blood scattering, and blood glucose level measurement with the body fluid component measuring apparatus 1 will be described with reference to the flowchart shown in fig. 2, 9, 26 to 31, and 32.

First, the puncture instrument 13 is inserted into the fitting portion 53 of the housing 5 through the opening 212 of the frame 21, and the reduced diameter portion 143 of the puncture needle 14 is fitted to the needle holder 411 (see fig. 27).

Subsequently, when the puncture instrument 13 is pushed in the proximal direction, the plunger 41 is moved in the proximal direction against the elastic force of the coil spring 42. The engaging portion 413 is urged by the elastic force of the elastic piece 412 to contact the inner peripheral surface of the inner cavity portion 52, and is inserted into the opening 57 when the engaging portion 413 is at the position of the opening 57 (see fig. 27). Thus, even when the pressing force in the proximal direction of the puncture instrument 13 is released, the engaging portion 413 engages with the opening 57, and 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, the preparation for puncturing by the puncturing mechanism 4 and the preparation for collecting blood (sample) are finished.

Then, a power switch not shown in the figure is turned on, and each part of the body fluid component measuring apparatus 1 is started to be in a measurable state. In addition, the electromagnetic valve 26 is closed.

Next, the fingertip (finger) 200 is pressed against the stopper 3. Thereby, the fingertip 200 is pressed against the abutting portion 163 of the puncture instrument 13. At this time, the tip opening 162 is closed with the fingertip 200 so as to reduce air leakage as much as possible (see fig. 28).

Then, the operation button 222 is pressed to drive the body fluid component measuring apparatus 1. Thereby, the routine shown in fig. 32 is implemented.

First, the needle body 141 of the puncture needle 14 punctures the surface of the fingertip 200 (step S407 in fig. 32).

In other words, the control mechanism 11 energizes the coil of the solenoid 28. Thereby, the plunger 281 of the solenoid 28 is moved in the direction indicated by the arrow in fig. 27, and comes into contact with the engagement portion 413, thereby pushing back the engagement portion 413 toward the inner cavity portion 52. Thereby, the engagement of the engaging portion 413 is released, and the plunger 41 is moved in the distal direction by the elastic force of the compressed coil spring 42, so that the needle body 141 protrudes from the distal opening 162 and punctures the skin of the fingertip 200 (see fig. 29). Bleeding occurs from the puncture site 210 of the needle body 141.

After the needle body141 pierces the fingertip 200, the coil spring 43 pushes the plunger 41 back in the proximal direction. After the damping movement, the plunger 41 is at rest at a position where the elastic force of the coil spring 42 and the elastic force of the coil spring 43 are balanced (see fig. 30). At this time, the blade tip of the needle body 141 is accommodated in the puncture instrument 13. Therefore, the blade edge of the needle body 141 does not protrude from the distal end opening 162 except during puncturing. Can eliminate the phenomenon of skin injury by mistake, and can prevent infection with good safety.

Next, the control means 11 starts controlling the drive of the pump 8 and the solenoid valve 26 (step S402 in fig. 32).

In other words, the control unit 11 controls the drive of the pump 8 and the solenoid valve 26 to alternately switch the pressure in the inner chamber 52 (including the puncture device 13) between the first pressure P1 and the second pressure P2, as shown in fig. 33. The pressure in the vicinity of the puncture site 210 of the needle body 141 of the fingertip 200 also fluctuates (changes) in the same manner as above.

In this case, first, the pump 8 is driven with the electromagnetic valve 26 closed to suck the air in the cavity 52 of the housing 5, and the pressure in the cavity 52 is reduced to the first pressure P1, and the first pressure P1 is maintained for a predetermined time.

Then, the pump 8 is stopped, the electromagnetic valve 26 is opened, the air in the inner chamber portion 52 is discharged, the pressure of the inner chamber portion 52 is made the second pressure P2, the second pressure P2 is maintained for a predetermined time, and the operation is repeated thereafter.

Thus, blood 220 may be aspirated from puncture site 210 (see fig. 30). In particular, a necessary amount of blood can be reliably secured in a short time as compared with a case where the pressure of the inner chamber section 52 is kept constant.

As described above, according to the body fluid component measurement device 1, the puncture operation and the decompression operation are performed by pressing the operation button 222 once, and the decompression release operation described below can be automatically started.

In the operation [ 4]above, blood 220 that has risen up in the form of particles at the puncture site 210 is sucked into the puncture instrument 13, comes into contact with the blood introduction guide member 166 formed inside thereof, is introduced into the test paper 18 through the blood passage 19, is supplied to the center of the test paper 18, and spreads radially (see fig. 2).

As the blood 220 is supplied to and scattered from the test strip 18, the glucose (component to be measured) in the blood 220 reacts with the reagent held on the test strip 18, and the test strip 18 develops color in accordance with the amount of glucose.

On the other hand, after step S402 shown in fig. 32 is performed, the control means 11 drives the measurement means 7, monitors (monitors) the color development of the test strip 18 by the measurement means 7, and determines whether or not blood is collected (step S403 in fig. 32).

In step S403, it is determined that blood is collected when the voltage value of the signal input from the light receiving element 72 of the measurement means 7 exceeds a preset limit value, and it is determined that blood is not collected when the voltage value is lower than the preset limit value.

The above limit values are set as: the voltage value of the signal before the color development of the test paper 18 is very large and the voltage value of the signal during the color development is very small.

In step S403, if it is determined that blood has not been collected, it is determined whether or not the time has elapsed (step S404 in fig. 32).

In step S404, if it is determined that the time has not elapsed, the process returns to step S403, the process from step S403 onward is performed again, and if it is determined that the time has elapsed, the error process is performed (step S405 in fig. 32).

In step S405, the pump 8 is stopped, the electromagnetic valve 26 is opened, the reduced pressure state is released, and an error is displayed on the display unit 12 or notified by sound through the sound output unit 32. It is needless to say that the error may be reported by both the display unit 12 and the audio output unit 32.

The operator (user) can grasp that there is an error (any trouble) based on the error notification.

In step S403, if it is determined that blood has been collected, the pump 8 is stopped (step S406 in fig. 32).

Subsequently, the electromagnetic valve 26 is opened to release the decompression state of the inner chamber section 52 (including the puncture instrument 13) (step S407 in fig. 32).

When the electromagnetic valve 26 is opened, the outside air (atmosphere) flows into the inner cavity 52 (including the puncture device 13) and the puncture site 210 through the tubes 82 and 81 and the ventilation passage 54, and returns the inner cavity 52 (including the puncture device 13) and the puncture site 210 to the atmospheric pressure (see fig. 31).

If it is confirmed that the suction feeling of the peripheral portion of the puncture site 210 of the fingertip 200 has been eliminated and returned to the atmospheric pressure, the fingertip 200 is moved away from theabutment 163 of the puncture instrument 13.

After step S407 shown in fig. 32 is performed, the control unit 11 measures the degree of color development of the test strip 18 by the measurement unit 7, and performs correction such as calculation processing, temperature correction calculation, and hematocrit value correction calculation based on the obtained data to quantify the blood glucose level (step S408 in fig. 32).

In this case, since the reduced pressure state of the inner chamber 52 (including the puncture device 13), that is, the reduced pressure state of the housing space of the test strip 18 is released, components in the atmosphere (for example, oxygen, carbon dioxide, water vapor, and the like) necessary for the reaction between the glucose (component to be measured) in the blood 220 and the reagent held on the test strip 18 can be sufficiently supplied, and thus the blood glucose level can be measured more accurately.

Next, the calculated blood glucose level is displayed on the display unit 12 (step S409 in fig. 32).

This makes it possible to grasp the blood glucose level.

In step S407, after the decompression state is released, the electromagnetic valve 26 is closed again in preparation for the next measurement.

As described above, according to the body fluid component measuring apparatus 1, a sufficient amount of blood necessary for measurement can be collected reliably in a short time, and the blood glucose level (the amount of a predetermined component in the blood) can be measured accurately and reliably.

Further, since the puncture instrument 13 is provided with the test paper 18, puncture, collection of blood, and scattering and measurement (quantification of components) on the test paper 18 can be performed continuously, and thus, measurement of blood glucose level (component measurement) can be easily performed in a short time.

Further, since the preparation operation at the time of use is easy, it is also advantageous for the case of regular use or the case of repeated use.

The safety is improved by preventing an accident such as erroneous re-piercing of the living body surface after the piercing. Further, since the puncture needle 14 is not directly visible, the fear of puncture is also reduced.

As can be seen from the above, the body fluid component measuring apparatus 1 is suitable for use in a case where a patient measures his/her own blood glucose level or the like.

In addition, the body fluid component measuring apparatus 1 is simple in structure, small in size, light in weight, and inexpensive, and therefore is also suitable for mass production.

As shown in fig. 33, in the present embodiment, the puncture is performed before the start of driving of the pump 8 (time t1), but in the present invention, the puncture may be performed substantially simultaneously with the start of driving of the pump 8 (time t2) or after the start of driving of the pump 8 (time t3), for example. In other words, in the present invention, the puncture may be performed when the pressure in the inner cavity 52 (including the puncture instrument 13) is atmospheric pressure, or the puncture may be performed when the pressure is the first pressure P1.

Next, a second embodiment of the body fluid component measuring device according to the present invention will be described.

FIG. 34 is a vertical sectional view showing an example of the configuration of the main part of a body fluid component measuring device according to a second embodiment of the present invention. Note that description of points common to the body fluid component measurement device 1 of the first embodiment is omitted, and points different therefrom are mainly described. In fig. 34, the right side is referred to as the "base end" and the left side is referred to as the "tip end".

The body fluid component measurement device 1 of the second embodiment differs from the body fluid component measurement device 1 of the first embodiment in the configuration of the pressure adjustment mechanism.

That is, as shown in fig. 34, the body fluid component measuring device 1 is provided with a narrow tube 83 instead of the electromagnetic valve 26 of the body fluid component measuring device 1 according to the first embodiment.

The narrow tube 83 is formed of a cylindrical member, and a throttle (flow path) 831 is formed inside the tube. The narrow tube 83 is joined (connected) to an end of the tube 82, and a tip of the narrow tube 83 (the orifice 831) is opened to the outside of the main body 21.

The orifice 831 of the narrow tube 83 has a small diameter structure, and therefore, the resistance to the passage of air is relatively large. The diameter of the throttle 831 is not particularly limited, but is preferably about 0.01 to 0.3mm, for example. The length of the throttle 831 is not particularly limited, but is preferably about 1 to 15 mm. By setting the diameter of the orifice 831 within the above range, a necessary and sufficient resistance to the passage (flow) of air can be obtained.

The pipes (flow paths) 81 and 82 and the narrow pipe 83 constitute a decompression release mechanism, and the decompression release mechanism and the pump 8 constitute a pressure adjustment mechanism.

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

When the body fluid component measurement device 1 collects blood from the puncture site, the drive of the pump 8 is controlled based on the information from the pressure sensor 27, and the pressure inside the inner chamber 52 (including the puncture instrument 13) is reduced, so that the pressure varies (changes) with time.

The pressure pattern in the lumen portion 52 when the blood is collected includes a decompression time, and the pressure may vary with time, but is not particularly limited. An example thereof is explained below.

Fig. 35 is a graph showing a pressure pattern in the lumen portion 52 at the time of blood collection.

As shown in the drawing, when blood is collected by the body fluid component measurement device 1, the pressure in the lumen portion 52 is once reduced to the first pressure P1 lower than the atmospheric pressure by controlling the driving of the pump 8, and then the pressure is gradually increased.

This makes it possible to reliably collect a sufficient amount of blood required for measurement in a shorter time.

The first pressure P1 is preferably about 300 to 600mmHg, more preferably about 400 to 600 mmHg.

Therefore, a sufficient amount of blood necessary for measurement can be collected more reliably in a shorter time.

The rate of increase (pressurization rate) of the pressure in the inner chamber section 52 from the first pressure P1 is preferably about 100 to 300mmHg/sec, more preferably about 200 to 250 mmHg/sec.

Therefore, a sufficient amount of blood necessary for measurement can be collected more reliably in a shorter time.

The supercharging speed may be set arbitrarily, for example, according to the number of narrow tubes 83, the number of throttle holes 831, and the adjustment of the diameter of the throttle holes 831.

In this body fluid component measurement device 1, since the flow rate of air sucked by driving the pump 8 is greater (greater) than the flow rate of outside air (atmospheric air) flowing in from the orifice 831 of the narrow tube 83, the suction of air in the cavity 52 of the housing 5 is started when the pump 8 is driven, and the pressure of the cavity 52 (including the inside of the puncture instrument 13) is thereby made the first pressure P1. That is, the inner cavity 52 (including the puncture instrument 13) is in a decompressed state.

When the pump 8 is stopped, the outside air flows into the lumen portion 52 (including the inside of the puncture device 13) and the puncture site 210 through the orifice 831 of the narrow tube 83, the tubes 82 and 81, and the ventilation passage 54, and the pressure of the lumen portion 52 (including the inside of the puncture device 13) is gradually increased from the first pressure P1, thereby releasing the decompression state of the lumen portion 52 (including the inside of the puncture device 13) and the puncture site 210. In other words, the cavity 52 (including the puncture instrument 13) and the puncture site 210 are returned to the atmospheric pressure.

As shown in fig. 35, the puncturing may be performed at any time before the start of the driving of the pump 8 (time t1), substantially simultaneously with the driving of the pump 8 (time t2), or after the start of the driving of the pump 8 (time t 3). In other words, the puncture can be performed when the pressure in the inner chamber section 52 (including the puncture instrument 13) is atmospheric pressure, or the puncture can be performed when the inner chamber section 52 is in a depressurized state.

The rate of increase (supercharging rate) of the pressure of the inner chamber section 52 from the first pressure P1 may be constant or may vary (change) with time.

The body fluid component measurement device 1 may have only one cycle (the cycle shown in fig. 35) in which the pressure in the inner chamber 52 is once set to the first pressure P1 lower than the atmospheric pressure and then the pressure is gradually increased, or may have a plurality of cycles.

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

The body fluid component measuring device according to the third aspect of the present invention has been described above based on the embodiments shown in the drawings. However, the present invention is not limited to this, and for example, the configuration of each part may be replaced with any configuration that can exhibit the same function.

In the present invention, the given configurations of the above embodiments may be combined as appropriate.

In the above embodiment, blood was described as a representative of the collected body fluid, but in the present invention, the collected body fluid is not limited to this, and may be sweat, lymph, or marrow fluid, for example.

In the above-described embodiment, the component to be measured is exemplified by glucose (blood glucose level), but the present invention is not limited to this in terms of the component to be measured, and may be, for example, protein, cholesterol, uric acid, creatine amide, inorganic ions such as ethanol and sodium.

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, or may measure the amount and the property of the predetermined component.

In the above embodiment, the blood collection detection means for detecting the collection of blood and the measurement means for measuring the amount of the predetermined component in the blood are provided in combination (in the embodiment, this means is referred to as "measurement means"), but the blood collection detection means and the measurement means may be provided separately in the present invention.

In the above embodiment, as the blood collection detection means, a means for optically detecting the collection of blood is used, but the present invention is not limited thereto, and other means for electrically detecting, for example, may be used.

In the present invention, when a blood collection and detection mechanism that optically detects collection of blood is used, the detection is not limited to color development (color development) of a test strip that detects a reaction between a component in blood and a reagent, and other cases, such as introduction of blood into a blood passage (blood channel) that supplies blood to a test strip of a puncture device, may be detected.

In the case of detecting the introduction of blood into the blood passage, for example, a configuration may be adopted in which at least a portion near the blood passage in the puncture instrument is formed by a member having translucency (transparency), light is irradiated to the blood passage via a blood collection and detection means, reflected light or transmitted light is received, photoelectric conversion is performed, and the voltage output by the blood collection and detection means is monitored via a control means. When blood is introduced into the blood passage, the color of the portion changes to substantially red-black, and therefore the amount of reflected light or transmitted light from the portion changes, the voltage output from the blood collection detection means changes, and blood collection can be detected by detecting the change in the output voltage (amount of light).

As the blood collection detection means for electrically detecting the blood collection, for example, a sensor (electrode) for detecting (measuring) the impedance of the blood path of the puncture device or the like, a biosensor, or the like can be used.

In the case of using the biosensor, for example, when blood is introduced into the blood channel, the current output from the biosensor changes, and therefore detection of the change in the output current (current value) enables detection of blood collection.

In addition, in the case of using a sensor for detecting the impedance, for example, when blood is introduced into the blood passage, the impedance between the sensor electrodes changes, and therefore, the detection of the change in the impedance enables detection of blood collection.

The body fluid component measuring apparatus of the present invention optically measures (colorimetrically measures) the color development intensity of the developed test strip by the reaction between the component in the blood and the reagent, and converts and displays the color development intensity into a measured value.

In the above embodiment, the reduced pressure state is released before the measurement, but in the present invention, a structure in which the reduced pressure state is relaxed before the measurement may be adopted.

In the present invention, the driving of the puncture mechanism and the pressure adjustment mechanism may be started manually or automatically.

In the present invention, a puncture instrument retracting mechanism for moving the housing 5 and the puncture instrument 13 attached to the housing 5 in a direction away from the fingers (proximal direction) may be provided. The puncture instrument retracting mechanism may have the same configuration as that described with reference numeral 61 in the embodiments of the present invention according to the first or second aspect.

Further, in the present invention, the body fluid component measurement device 1 of the first embodiment may be a system including the pressure detection means and the notification means defined in the second embodiment, or a system including the pressure adjustment means defined in (25) of the third embodiment, or a system including both of them.

The mechanisms added to the first embodiment are the same as those described in the second and third embodiments, and redundant description thereof will be omitted here.

Briefly, in the first aspect, the body fluid component measuring device further includes a pressure detecting means for detecting the pressure in the storage space and a notifying means for notifying predetermined information, and the body fluid component measuring device is configured to perform pressure reduction on the storage space by the pressure reducing means and to notify the pressure reducing means by the notifying means based on information from the pressure detecting means.

Alternatively, in the first aspect, the body fluid component measuring device may further include a pressure adjusting mechanism for adjusting the pressure in the accommodating space of the puncture needle.

Further, the body fluid component measuring device of the first aspect may be configured to include a pressure detecting means for detecting the pressure in the storage space and a notifying means for notifying predetermined information, to perform pressure reduction on the storage space by the pressure reducing means and to notify the pressure reducing means by the notifying means based on information from the pressure detecting means, or may be a body fluid component measuring device including a pressure adjusting means for adjusting the pressure in the storage space of the puncture needle.

Industrial applicability of the invention

As described above, according to the present invention, it is possible to provide a body fluid component measuring device capable of accurately and reliably measuring a predetermined component in a body fluid (e.g., blood) in a short time when blood is collected (e.g., when blood is collected from a puncture site).

In particular, the skin can be prevented from being punctured excessively, and thus the burden on the patient can be reduced.

Further, in the case where the pressure adjusting mechanism is provided, since the space (for example, the accommodating space of the puncture needle) is depressurized and the pressure is varied with time, a sufficient amount of blood necessary for measurement can be collected reliably in a short time, and further, measurement of a predetermined component in a body fluid can be performed reliably in a short time.

When a test piece is provided in the puncture instrument, puncture, blood collection, and scattering and measurement (quantification of components) on the test piece can be performed continuously, and the measurement of the body fluid component can be performed easily and in a short time.

Since the preparation operation at the time of use is easy, it is also advantageous for the case of regular use or the case of repeated use.

The safety is improved by preventing an accident such as erroneous re-piercing of the living body surface after the piercing. In addition, since the puncture needle is not directly visible, the fear of puncture is also reduced.

As can be seen from the above, the body fluid component measuring apparatus is suitable for use in a case where a patient measures his/her own blood glucose level or the like.

In addition, the body fluid component measuring device is simple in structure, small in size, light in weight, and inexpensive, and therefore is suitable for mass production.

Claims (12)

1. A body fluid component measuring device to be used after attaching a puncture instrument having a puncture needle and a test paper,

the puncture device having the puncture needle and the test paper further includes a case, the test paper being disposed on an outer peripheral portion of the case, the case having a contact portion at a distal end thereof, the contact portion being in contact with a skin of a puncture site, and an opening at an inner side of the case;

the body fluid component measuring device includes:

a stopper portion against which the punctured epidermis is made to abut;

a housing space for holding the puncture instrument;

a puncture mechanism for driving the puncture needle to puncture the epidermis attached to the stopper;

a decompression mechanism for bringing the skin puncture site of the puncture needle into a decompressed state together with the accommodation space of the puncture device;

a measuring mechanism for measuring the amount of a predetermined component in the body fluid collected from the puncture site and scattered on the test strip;

a body fluid collection detection mechanism for detecting collection of the body fluid; and

a decompression release mechanism for releasing or relaxing at least the decompression state of the accommodating space of the test strip,

and adopts the following constitution: when the collection of the body fluid is detected by the body fluid collection/detection means, the reduced pressure state of at least the housing space of the test strip is released or relaxed by the reduced pressure release means, and thereafter the amount of a predetermined component in the collected body fluid is measured by the measurement device.

2. A body fluid component measuring apparatus according to claim 1, wherein a predetermined component in the atmosphere is required for said measurement.

3. A body fluid component measuring device according to claim 1, wherein said decompression canceling mechanism includes a flow path for communicating said accommodating space with the outside, and a valve for opening and closing said flow path.

4. A body fluid component measuring device according to claim 1, wherein said decompression canceling means has a flow path for communicating said accommodating space with the outside, and at least a part of said flow path has a portion having a relatively large resistance to the passage of air.

5. A body fluid component measuring device according to claim 1, wherein at least a part of said measuring means and at least a part of said body fluid collecting and detecting means are used in combination.

6. The body fluid component measuring device according to claim 1, wherein the body fluid component measuring device comprises a housing having the puncture mechanism built therein and holding the puncture instrument,

the decompression mechanism brings the accommodation space in the housing into a decompressed state.

7. A body fluid component measuring device according to claim 6, wherein said decompression canceling mechanism cancels or alleviates a decompressed state of said housing space in said case.

8. The body fluid component measuring device according to claim 1, wherein the actuation of said puncturing means and the actuation of said pressure reducing means are started substantially simultaneously.

9. The body fluid component measuring device according to claim 1, wherein the puncture device has a stopper portion against which the punctured epidermis comes into contact.

10. A body fluid component measuring device according to claim 1, wherein said test strip is a test strip for measuring blood glucose.

11. The body fluid component measuring device according to claim 1, further comprising:

a pressure detection mechanism for detecting a pressure of the accommodation space; and

a notification mechanism for notifying given information,

the pressure detection means detects a pressure reduction state of the storage space, and the notification means notifies that the storage space is in a pressure reduction state.

12. A body fluid component measuring apparatus according to claim 1, further comprising a pressure adjusting mechanism for adjusting a pressure in the accommodating space of said puncture needle,

and adopts the following constitution: when the body fluid is collected from the puncture site, the pressure in the accommodating space is reduced by the pressure adjusting mechanism, and the pressure is varied with time.

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