JP4233496B2 - Body fluid testing device - Google Patents

Description

  The present invention relates to a bodily fluid testing device that performs testing by puncturing a puncture needle on the surface of a living body such as a fingertip when testing bodily fluid such as blood.

In recent years, with the increase in the number of diabetic patients, self blood glucose level measurement in which patients themselves monitor fluctuations in daily blood glucose levels has been recommended. For self blood glucose level measurement, a test paper that is colored according to the amount of glucose in the blood is attached, blood is supplied to the test paper, and the degree of coloration is measured optically (color measurement) to determine the blood glucose level. A blood glucose meter that quantifies the blood glucose level is used. Prior to this measurement, the patient needs to squeeze out the blood by pressing the skin around the puncture portion with a finger or the like after puncturing the skin of the fingertip using a puncture tool equipped with a puncture needle or a knife. And since the puncture device and the blood glucose measuring device are separate, it is necessary to switch from the puncture device to the blood glucose measuring device in the state of bleeding, and the operability is poor, which is not preferable from the viewpoint of hygiene.
Therefore, a device in which a conventional puncture device and a blood glucose measuring device are integrated is disclosed in Japanese Patent Laid-Open No. 6-339473 (Patent Document 1). This blood glucose meter includes a puncturing means, a means for transferring body fluid to the chemical reagent for body fluid, and a means for optically measuring the chemical reagent for body fluid and displaying the result in the housing. However, in this blood glucose meter, since the amount of bleeding is insufficient even when puncturing is performed, it is necessary to squeeze the body fluid by squeezing with a finger or the like after puncturing, and there is not much difference in operability from the conventional one. In addition, as a blood glucose meter, there is one disclosed in JP-A-9-276235 (Patent Document 2). This blood glucose meter includes a puncturing means, a compression band for pressing a finger, and a means for measuring and displaying a body fluid component in the housing. However, although this blood glucose meter can collect a necessary amount of body fluid due to the effect of the compression band, when the finger is pulled out from the compression band after use, the body fluid remaining on the fingertip adheres to the compression band and causes infection, etc. Have the risk of

JP-A-6-339473 JP-A-9-276235

  An object of the present invention is to provide a bodily fluid test apparatus that can continuously perform puncture, bodily fluid collection, and measurement in view of the above-described problems of the prior art and that is extremely unlikely to cause bodily fluid adhesion.

What achieves the above object is as follows.
(1) A bodily fluid testing device for puncturing the skin to collect a small amount of bodily fluid and measuring the components of the bodily fluid, the bodily fluid testing device comprising a case having a lid member that can be opened and closed, and the bodily fluid testing device a piercing member detachably mounted includes a protrusion capable of puncturing needle, body fluid guide path to the detection chip and detection chip includes a reagent that reacts with a specific component in the body fluid is detachably attached to the body fluid testing device and A detection chip member having a suction port communicating with the body fluid guiding path ; a puncture member mounting portion; a puncture start switch; and an elastic member for biasing the puncture member mounting portion; and a temporary protrusion of the puncture needle A puncture needle drive mechanism for performing, a suction mechanism for sucking a puncture site with an electric pump, a reduced pressure state release mechanism for releasing a reduced pressure state by the suction mechanism, and the detection chip after contacting the body fluid Possess a detection mechanism for detecting the state, and fluid status evaluator for evaluating the fluid state from the detection result by the detection mechanism, and a display mechanism for displaying the evaluation results of body fluid state evaluation mechanism, further, the lid The member has an opening into which a fingertip can be inserted with the lid member closed, and the fingertip inserted through the opening is pressed against the suction port of the detection chip member. A bodily fluid testing device that can be formed .
( 2 ) The body fluid testing device according to (1), further including a lid member sensor that detects opening and closing of the lid member.
( 3 ) The body fluid testing device according to (1) or (2) , wherein the lid member includes a storage unit that can store a plurality of spare puncture members and spare detection chip members.
( 4 ) The puncture member and the detection tip member constitute a chip puncture needle assembly in which the puncture member and the detection tip member are integrated, and the chip puncture needle assembly includes the suction port that can be in close contact with the fingertip above the cutting edge of the puncture needle. one end opening of the body fluid taxiway humoral testing apparatus according to any one of (1) to those other end projects into the suction port extends to the tip (3).
( 5 ) The bodily fluid testing device includes a suction mechanism control mechanism that detects the operation of the puncture needle drive mechanism including the puncture start switch, activates the suction mechanism based on the detection result, and stops the operation of the suction mechanism. The bodily fluid test | inspection apparatus in any one of said (1) thru | or (4) provided.

The bodily fluid testing device of the present invention is a bodily fluid testing device for puncturing the skin, collecting a small amount of bodily fluid, and measuring the components of the bodily fluid, and the bodily fluid testing device includes a case provided with an openable / closable lid member; A detection chip including a puncture member that includes a puncture needle that is detachably attached to the bodily fluid testing device, and a reagent that is detachably attached to the bodily fluid testing device and reacts with a specific component in the bodily fluid, and the detection chip A detection chip member having a body fluid guiding path, a puncture member mounting portion, a puncture start switch, and an elastic member for biasing the puncture member mounting portion, and a puncture for temporarily projecting the puncture needle Detecting the operation of a needle drive mechanism, a suction mechanism for sucking a puncture site with an electric pump, and a puncture needle drive mechanism including the puncture start switch, and operating the suction mechanism based on the detection result; A suction mechanism control mechanism for stopping the operation of the pulling mechanism, a decompression state release mechanism for releasing the decompression state by the suction mechanism, a detection mechanism for detecting the state of the detection chip after contact with body fluid, and the detection A body fluid state evaluation mechanism that evaluates a body fluid state from a detection result by the mechanism; and a display mechanism that displays an evaluation result by the body fluid state evaluation mechanism.
In particular, since it is equipped with a suction means, it is possible to reliably collect body fluid, and by providing a decompression state release mechanism, it is possible to prevent excessive decompression state from being sustained and to reduce the burden on the puncture site, and further to the inside of the body fluid device There is also very little adhesion.

The bodily fluid test | inspection apparatus of this invention is demonstrated in detail based on the preferred Example shown on drawing.
FIG. 1 is an external view of an embodiment of a bodily fluid testing device of the present invention, FIG. 2 is a plan view with a protective cover removed from the bodily fluid testing device shown in FIG. 1, and FIG. 3 is a bodily fluid testing shown in FIG. It is internal structure explanatory drawing which fractured | ruptured the case part of the apparatus.
The body fluid testing device 1 of the present invention is a body fluid testing device for puncturing the skin to collect a small amount of body fluid and measuring the components of the body fluid. The body fluid testing device 1 is detachably attached to the case 2, the puncture member 16 that is detachably attached to the case 2 and includes a puncture needle that can protrude into the opening 8 for puncturing the fingertip, and the case 2. In addition, the detection chip 25 including a reagent that reacts with a specific component in the body fluid, the detection chip member including the body fluid guiding path to the detection chip 25, the puncture member mounting portion, the puncture start switch, and the puncture member mounting portion are energized. A puncture needle drive mechanism 10 for temporarily projecting the puncture needle formed substantially air-tight except for the puncture needle protrusion, and an electric pump 12a. By detecting the inside of the drive mechanism, the operation of the suction mechanism 12 for sucking the peripheral part including the puncture part of the fingertip by the puncture needle and the puncture needle drive mechanism 10 including the puncture start switch are detected. Based on this detection result, the suction mechanism 12 for starting the operation of the suction mechanism 12 and starting the operation of the suction mechanism 12 and stopping the operation of the suction mechanism 12, and the decompression state release for releasing the decompression state by the suction mechanism 12 The mechanism 31, a detection mechanism for detecting the state of the detection chip 25 after contact with the body fluid, a body fluid state evaluation mechanism for evaluating the body fluid state from the detection results of the detection mechanisms 104 and 105, and an evaluation result by the body fluid state evaluation mechanism And a display mechanism 5 for displaying.

The body fluid testing device 1 according to this embodiment includes a case 2 and an internal mechanism housed in the case 2. In the embodiment shown in FIGS. 1 to 5, the case 2 includes a case main body 2a and a lid member 2b having one end portion rotatably attached to the case main body 2a. The lid member 2b includes an opening 8 into which a fingertip can be inserted, and a cover 4 attached to the side surface of the opening 8. The lid member may not be provided. Further, the lid member does not include an opening or the like into which a fingertip can be inserted, and the case body 2a can be simply encapsulated with a mounting portion of a chip puncture needle assembly to be described later. The one end part may be rotatably attached. Further, as the lid member, the lid member may not be completely closed in a state where a chip puncture needle assembly, which will be described later, is mounted on the mounting portion.
The internal mechanism housed in the case body 2a includes a puncture needle driving mechanism 10 for temporarily projecting the puncture needle, and a suction mechanism 12 for sucking a peripheral portion including a puncture portion of the fingertip by the puncture needle. The body fluid state is evaluated from the decompression state release mechanism 31 for releasing the decompression state by the suction mechanism 12, the detection mechanisms 104 and 105 for detecting the state of the detection chip 25 after the body fluid contact, and the detection result by the detection mechanism. A body fluid state evaluation mechanism and a display mechanism 5 for displaying an evaluation result by the body fluid state evaluation mechanism.

  And in this bodily fluid test | inspection apparatus 1, in use, the detection chip | tip 25 containing the puncture member 16 provided with the puncture needle which can protrude for the fingertip puncture in the opening part 8, and the reagent which reacts with the specific component in body fluid, A detection chip member having a body fluid guiding path to the detection chip 25 is attached. In this embodiment, a tip puncture needle assembly 22 in which the puncture member 16 and the detection tip member are integrated is used, and the tip puncture needle assembly 22 is attached to the assembly mounting portion 7 of the body fluid testing device. Removably mounted. The tip puncture needle assembly 22 is replaced for each inspection. Further, as shown in FIG. 3, the lid member 2b is provided with a storage portion 15 in which a plurality of spare tip puncture needle assemblies 22 can be stored, and the upper surface of the lid member 2b is provided with a top surface as shown in FIG. A small window 17 for confirming the remaining number of unused tip puncture needle assemblies 22 is provided, and the remaining number of tip puncture needle assemblies can be confirmed from the outside.

The chip puncture needle assembly 22 includes a puncture member (lancet) 16, a cylindrical member that movably accommodates the puncture member 16, and an assembly body member to which the distal end portion of the cylindrical member is fixed. The assembly is located above the cutting edge of the puncture needle of the puncture member 16 and includes an annular opening 26 and a detection chip 25 that can be in close contact with the fingertip. Further, one end opening projects into the annular opening 26 and the other end is A body fluid guiding path extending to the vicinity of the chip 25 is provided. For this reason, blood due to bleeding generated by being punctured by the puncture member 16 passes through the guide path and is sent to the detection chip 25.
The guide path is desirably designed to reduce the remaining amount of body fluid, although its cross-sectional shape and length vary depending on the amount of body fluid required for measurement. Specifically, the cross-sectional shape may be a tubular shape, a V-shaped groove, or a rectangular groove, but a thin rectangular shape is preferable because the remaining amount of body fluid can be reduced. The thickness is preferably about 0.05 to 0.5 mm, and the width is preferably about 0.5 to 3 mm. A length of about 5 mm to 15 mm is appropriate.

The annular opening (suction port) 26 of the tip puncture needle assembly 22 is a part that contacts a living body surface such as a fingertip, upper arm, abdomen, thigh, or earlobe. The opening diameter (opening area) of the suction port 26 is adjusted so that suction blood can be collected satisfactorily regardless of individual differences such as sex and age, and the puncture site. Specifically, the opening diameter of the suction port 26 is preferably 4 to 10 mm, and more preferably 4 to 6 mm when the puncture site is a finger or an earlobe. The outer peripheral edge of the suction port 26 of the tip puncture needle assembly 22 has a shape suitable for exerting the effect of stimulating the periphery of the puncture portion when pressed against the surface of the living body (skin) and relieving pain during puncture. Yes. Further, when the inside of the puncture device 11 is in a decompressed state, the shape is suitable for preventing air from flowing into the puncture device 11 from between the tip puncture needle assembly 22 and the living body surface.
It is desirable to provide a body fluid introduction guide part at the edge of the guide path of the annular opening 26. The body fluid introduction guide portion has a function of guiding the body fluid to the guide path opening when the body fluid comes into contact therewith. As the body fluid guide portion, a rail-like guide is preferably provided so as to protrude on both the left and right sides of the periphery of the guide passage opening. The body fluid introduction guide portion preferably has a width of about 1 to 3 mm, a height of about 0.5 to 3 mm, and a length of about 1 to 3 mm.
The tip puncture needle assembly 22 is preferably made of a transparent or colored transparent material so that the bleeding state after the puncture can be visually confirmed, in order to ensure the internal visibility. It may be.

The detection chip 25 is suitable for a target body fluid test. For example, when measuring glucose in blood, glucose oxidase, peroxidase and a color reagent are carried. The component to be measured is not limited to glucose (blood glucose level) but may be, for example, protein, cholesterol, uric acid, creatinine, alcohol, sodium sugar inorganic ion, hemoglobin (occult blood), or the like. In addition, as the detection chip substrate, liquid-absorbing (hydrophilic) paper, film, nonwoven fabric, or the like is used.
The portion 7 exposed in the lid member 2b of the internal mechanism of the body fluid test apparatus 1 is the mounting portion 7 of the tip puncture needle assembly 22, and the mounting portion 7 is chamfered at four corners. In addition, it has a quadrangular prism shape that is obliquely cut from the center of the upper surface, and a gasket that is in close contact with the inner surface of the tip puncture needle assembly 22 is provided on the side surface.

  The puncture needle drive mechanism 10 for temporarily projecting the puncture needle includes a cylindrical housing 27, a plunger 28 that slides inside the housing 27, and a shaft 21 that is fixed to the rear end of the plunger 28. The adjustment cover 30 attached to the rear end of the housing 27 so as to enclose the rear end of the shaft 21, the elastic member (spring member) 18, and the opening cover that covers the side opening 27 a of the housing 27 9 and a puncture start switch member 3. The plunger 28 has a locking claw portion 19 that penetrates into the side opening 27a of the housing 27 on the side surface, can penetrate into the cylindrical member of the tip puncture needle assembly 22 at the tip, and punctures the puncture member 16 at the tip. A cylindrical puncture needle holder portion 20 capable of holding a needle hub is provided. One end (front end) of the elastic member 18 is fixed to the rear end (connecting portion with the shaft 21) of the plunger 28, covers the front end portion of the shaft, and the rear end is formed at the center of the housing 27. It is fixed to an elastic member fixing portion 29 protruding inward. Therefore, in a state where the locking claw portion 19 of the plunger 28 is engaged with the opening portion of the housing 27 as shown in FIG. 7, the elastic member 18 has the rear end of the plunger 28 and the elastic member of the housing 27. It is in a compressed state between the fixed portions 29. Further, the shaft 21 includes a rib 21a at the rear end portion, and the adjustment cover 30 includes a rib 30a provided at an intermediate portion thereof so as to be able to contact the rib 21a. The amount of protrusion of the puncture needle is adjusted by adjusting the position of the adjustment cover.

  Further, as shown in FIG. 9, the elastic member 18 is configured so that the tip of the puncture needle is open to the tip puncture needle assembly 22 when the locking claw portion 19 of the plunger 28 is not engaged with the opening of the housing 27. The length is such that it does not protrude from the part. For this reason, when the fingertip is pulled out after the puncture is completed, the puncture needle is not caught on the fingertip. The locking claw portion 19 of the plunger 28 has a rod-like shape with a predetermined length, one end (rear end) being fixed to the plunger 28 and the tip being a free end, and the tip slightly outward. It protrudes. For this reason, the claw portion 19 easily enters the engaging claw intrusion opening portion 27a provided in the housing 27, and both of them come into contact with each other (the front end surface of the claw portion and the inner end surface of the opening portion). , Engage. The side opening 27a is covered with the opening cover 9, and the puncture start switch member 3 is provided on the outer side. The switch member 3 includes a pressing operation portion 3a and a disengaging tip portion 3b, and the disengaging tip portion 3b opens a side opening portion of the housing 27 (a tip portion of a claw that has entered the opening portion). The outer cover 9 can be pressed from the outside. For this reason, when the switch member 3 is pressed, the puncture needle is urged by the compression release of the compressed spring as shown in FIG. 8, protrudes from the assembly 22 and punctures the finger 23. The chip puncture needle assembly 22 can puncture without limiting the puncture site.

Note that the present invention is not limited to such a configuration. For example, the start of puncture is configured such that the tip puncture needle assembly 22 can be moved back and forth, and the tip puncture needle assembly 22 and the body fluid testing device 1 (case) A mechanical sensor such as a micro switch may be provided in the joint portion of 2), and the puncture may be started by slightly pushing the puncture site with the tip puncture needle assembly 22 in contact.
In addition, the body fluid testing device 1 of this embodiment is a mechanical chip puncture needle assembly for removing the chip puncture needle assembly 22 without touching the reagent portion or the body fluid spotted portion of the chip puncture needle assembly 22. A release lever 6 is provided. The release lever 6 has an exposed protrusion 6a. When the release lever 6 is moved in the direction of the arrow in FIG. 4, the tip puncture needle assembly 22 is detached from the mounting portion 7 by being pushed by the protrusion 6a.

Next, the suction mechanism 12 for sucking a peripheral part including the puncture part of the fingertip by the puncture needle and the reduced pressure state release mechanism 31 for releasing the reduced pressure state by the suction mechanism 12 will be described.
The suction mechanism 12 includes a suction pump (electric pump) 12a, a tube 12b connecting the suction pump 12a and the cylindrical housing 27 of the puncture needle drive mechanism 10, and an exhaust pipe 12c connected to the suction pump 12a. The decompression state release mechanism 31 is constituted by a decompression release valve provided in the middle of the tube 12b. For this reason, the inside of the cylindrical housing 27 of the puncture needle drive mechanism 10 is substantially airtight except for an opening 26 (a portion that is closed by a finger during use) from which the puncture needle 16 protrudes. By depressurizing the inside of the cylindrical housing 27 of the puncture needle drive mechanism 10, it is possible to suck the part of the finger that is in close contact with the opening. As the suction pump (electric pump), an electric suction pump such as a linear motion type (piston type or diaphragm type), a rotary motion type, or a sliding motion type is used. The decompression state release mechanism 31 may be provided directly on the suction pump or on the cylindrical housing 27 of the puncture needle drive mechanism 10.

  Any decompression release valve may be used as long as it can perform flow control or pressure control mechanically, electromagnetically, or mechanically. For example, a throttle valve, a flow rate adjustment valve, a solenoid valve, etc. are mentioned. Further, as the throttle valve, one using a fine tube is suitable, and in the illustrated embodiment, a throttle valve (low intake valve) made up of a fine tube is used. The diameter (inner diameter) of the micro-thin tube is determined from the exhaust speed of the electric pump and the gas flow rate from the narrow tube. Note that the reduced pressure state release mechanism may be achieved by providing a slightly low degree of airtightness of the cylindrical housing 27 of the puncture needle drive mechanism 10 without providing a special configuration as described above. Specifically, it is conceivable to provide pores on the side surface of the housing 27 and to provide a slight gap between the housing 27 and the fixing portion of the adjustment cover 30. A reduced pressure release mechanism can be provided to the puncture needle drive mechanism 10 by a minute intake port formed by these pores, a low-volume intake valve, and the like.

Next, the operation of the puncture needle drive mechanism 10 including the puncture start switch is detected, a suction mechanism operation function for starting the operation of the suction mechanism 12 based on the detection result, and a suction mechanism control unit for stopping the operation of the suction mechanism 12; A detection mechanism for detecting the state of the detection chip 25 after the body fluid contact will be described.
The body fluid testing device 1 of this embodiment is irradiated with light from the light emitting element 104 and the light emitting element 104 for applying light to the detection chip 25 as a detection mechanism for detecting the state of the detection chip 25 after the body fluid contact. The light receiving element 105 for receiving the reflected light reflected by the light is output from the light receiving element. An analog signal corresponding to the amount of received light is output from the light receiving element and amplified by the amplifying unit 106 and then digitally converted by the AD converter 107. It is converted into a signal and input to the control unit 100 described later. The measurement of the amount of reflected light using the light emitting element and the light receiving element (detection by the detection chip 25) is continuously performed at regular time intervals (for example, every second) until the control unit determines that the measurement is finished.

In addition, the body fluid testing device 1 of this embodiment includes a chip puncture needle assembly mounting monitoring sensor 103 and a lid opening / closing sensor 115, and can detect from a resting state to a measurable state of the body fluid testing device 1. Specifically, the lid opening / closing sensor 115 detects the opening of the lid member 2b, and the tip puncture needle assembly attachment monitoring sensor 103 confirms that the tip puncture needle assembly is attached. Detect something.
The lid opening / closing sensor 115 is preferably a mechanical type, but may be an electric type or an optical type. When the body fluid test apparatus 1 optically measures the reaction at the detection chip 25, the cover member 2b of the case 2 and the protective cover 4 provided on the cover member 2b prevent external light from entering the detection chip 25. Prevents and improves measurement accuracy.

In FIG. 10, the block diagram of the electrical component part of the bodily fluid test | inspection apparatus 1 of this Example is shown.
The body fluid testing device 1 includes a light-emitting element 104, a light-receiving element 105, an amplifier 106 for the light-receiving element 105, and a light-receiving signal forming unit including an AD converter 107 that returns a signal output from the amplifier 106. ) 114, lid open / close detection sensor 115, pressure sensor 108 for detecting the pressure inside the puncture needle drive mechanism, suction pump 12a, puncture start detection sensor 110, tip puncture needle assembly attachment monitoring sensor 103, display unit 5, sound An output unit 113, a memory 112, and an external output unit 111 are provided, and these are electrically connected to the control unit 100. An AD converter and a memory that return a signal output from the control unit 100, the amplification unit, and the amplification unit are mounted on the substrate 24.

The control unit 100 is composed of a microcomputer, and calculates a target blood component such as blood glucose based on a signal from the light receiving element 105 (more precisely, a signal output from the light receiving signal forming unit). It has a function. Further, the control unit 100 controls the light emitting element, the suction pump, the display unit, the audio output unit, the memory, and the external output unit.
The display unit is for displaying a body fluid test result based on a signal from the control unit 100, and a liquid crystal display is preferably used. The sound output unit outputs a buzzer sound or a body fluid test result by sound based on a signal from the control unit 100 (body fluid state evaluation mechanism). The external output unit 111 is for outputting a body fluid detection result (for example, data such as a blood glucose level) stored in a memory (storage unit) to an external device such as a personal computer. In this case, the external output unit 111 incorporates a communication driver such as RS232C. When performing infrared communication, the external output unit 111 uses an infrared light emitting element and its drive circuit. The memory is for storing a body fluid detection result (for example, data such as a blood glucose level) together with a measurement time.

The chip puncture needle assembly mounting monitoring sensor 103 is for detecting whether or not the puncture tool has been pushed to a puncturable position, and may be any of a magnetic sensor, a mechanical sensor, and an optical sensor. Is preferred. The chip puncture needle assembly mounting monitoring sensor 103 is not provided, and the reflected light of the unused chip puncture needle assembly is received by the light emitting element 104 and the light receiving element 105, thereby confirming the mounting of the chip puncture needle assembly. You may do it.
The puncture start detection sensor is a sensor that detects that puncture has started, and is provided directly to the puncture start switch or at a site that is driven when the puncture needle drive mechanism 10 is punctured. The puncture start detection sensor may be any of a magnetic sensor, a mechanical sensor, and an optical sensor. The pressure sensor 108 is provided in a tube that communicates the suction pump and the inside of the puncture needle drive mechanism. As the pressure sensor, for example, a semiconductor type pressure sensor is preferably used. The pressure sensor may be provided inside the puncture needle drive mechanism. By providing this pressure sensor, it is possible to monitor whether or not the body fluid suction is correctly performed when the pump is operated. Specifically, it is possible to detect that the finger 23 and the opening of the tip puncture needle assembly 22 are not correctly contacted and that a leak has occurred, and this is detected by the control unit 100 by means of a warning display on the display unit or a voice output unit. An error message can be output.

Next, the operation of each part when collecting and measuring body fluid using the body fluid testing device 1 will be described.
When the lid member 2b of the case 2 of the body fluid testing device 1 is opened, the lid opening / closing sensor 115 notifies the control unit 100 that the lid has been opened, and displays an instruction to attach the chip puncture needle assembly 22 on the display unit 5. . Next, the tip puncture needle assembly 22 is set on the tip puncture needle assembly mounting portion 7 and pushed in until the locking claw portion 19 of the plunger 28 is engaged with the opening of the housing 27. Thereby, it will be in the state shown in FIG. 7, and the spring 18 will be hold | maintained in a compression state. In this state, the light receiving element is activated, and the detected signal is converted by the converter and input to the control unit, and the control unit determines that the tip puncture needle assembly 22 is attached. At the same time, the tip puncture needle assembly mounting monitoring sensor 103 detects whether or not the puncture tool has been pushed into a puncturable position, and the detection result is input to the control unit. When it is confirmed that the tip puncture needle assembly 22 has been pushed to a position where puncturing is possible, the display unit 5 displays a puncture startable state.

  Next, when the suction port 26 at the tip of the tip puncture needle assembly 22 is pressed against the puncture site such as a finger as shown in FIG. 6 and the puncture start switch member 3 is pushed in the direction of the arrow in FIG. By the tip portion 3b, the engaging claw intrusion opening portion of the housing 27 (the front end portion of the claw portion that has entered the opening portion) is pressed through the opening cover 9, and the locking claw portion 19 of the plunger 28 is pressed. The engagement with the opening of the housing 27 is released. As a result, the elastic member 18 is released from the compressed state, and the lancet 16 and the puncture needle holder portion 20 are accelerated and advanced, and puncture of the skin with the cutting edge of the lancet 16 is performed (FIG. 8). The post-puncture lancet 16 and the puncture needle holder 20 are housed in the case 2 by the damping movement of the elastic member 18 (FIG. 9).

  When the puncture start sensor detects the puncture start, the control unit 100 operates the electric pump 12a to suck the inside of the puncture needle drive mechanism in order to suck the peripheral part including the puncture part of the fingertip by the puncture needle. To do. Note that the suction means may be operated directly by the puncture start switch without providing the puncture start sensor. Moreover, the timing of starting the operation of the suction pump may be performed with a slight delay even if it is performed simultaneously with the puncture. The pressure by the suction pump is a negative pressure, preferably 200 mmHg to 600 mmHg, particularly preferably 400 mmHg or more. Thereby, a required amount of blood can be discharged from the puncture site in a short time. Body fluid that bleeds onto the skin penetrates the groove on the inner wall of the chip and soaks into the test paper. Measurement starts in this state, and the result is displayed on the display unit 5 (FIG. 6). After the measurement is completed, the tip puncture needle assembly 22 is removed from the mounting portion 7 by the tip puncture needle assembly release lever 6, and the measurement is completed.

And the bodily fluid test | inspection apparatus 1 of this Example is provided with a control part, and a control part is controlled so that the action | operation of the suction mechanism 12 stops using the state change signal of the detection chip 25 detected by a detection mechanism. Is. For this reason, the control unit 100 can determine that the body fluid has been sucked into the detection chip 25 based on the voltage change of the light receiving element input as a digital signal, and uses this to control the end of the operation of the suction pump. Note that the present invention is not limited to such a method, and the suction pump may be automatically stopped at a preset time.
When the body fluid is supplied to the detection chip 25, a component (for example, glucose) in the body fluid reacts with the reagent contained in the test paper, and a color change occurs, which is changed using the light emitting element and the light receiving element. The degree of fluid is detected, and the body fluid property (for example, blood glucose level) is calculated from the degree.

FIG. 1 is a front view of an embodiment of the body fluid testing device of the present invention. FIG. 2 is a plan view of a state in which the protective cover is removed from the body fluid testing device shown in FIG. FIG. 3 is an explanatory diagram of the internal structure in which the case portion of the body fluid testing device shown in FIG. 1 is broken. FIG. 4 is an explanatory diagram for explaining a mounting process of the tip puncture needle assembly to the body fluid testing device shown in FIG. FIG. 5 is a view showing a state in which the tip puncture needle assembly is mounted on the body fluid test apparatus shown in FIG. FIG. 6 is a diagram illustrating a state where a finger is inserted into the body fluid test apparatus illustrated in FIG. 5. FIG. 7 is a cross-sectional view of a state in which the tip puncture needle assembly is mounted on the body fluid testing device shown in FIG. FIG. 8 is a cross-sectional view of a state where a finger is punctured by the body fluid testing device shown in FIG. FIG. 9 is a cross-sectional view of the state in which the inspection by the body fluid inspection device shown in FIG. 1 is completed. FIG. 10 is a block diagram showing a circuit configuration of the body fluid testing device of the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Body fluid test | inspection apparatus 2 Case 2a Case main body 2b Cover member 3 Puncture start switch member 4 Cover 5 Display mechanism 7 Mounting part 8 Opening part 10 Puncture needle drive mechanism 11 Puncture instrument 12 Suction mechanism 12a Electric pump (suction pump)
12b Tube 16 Puncture member 18 Elastic member 22 Tip puncture needle assembly 31 Depressurized state release mechanism 100 Control unit 103 Chip puncture needle assembly mounting monitoring sensor 104 Light emitting element 105 Light receiving element 108 Pressure sensor 110 Puncture start detection sensor

Claims (5)

A body fluid testing device for puncturing the skin to collect a small amount of body fluid and measuring the components of the body fluid, the body fluid testing device being detachable from the case having a lid member that can be opened and closed, and the body fluid testing device A puncture member having a puncture needle attached to the body and capable of projecting, a detection chip including a reagent that is detachably attached to the body fluid testing device and reacts with a specific component in the body fluid, a body fluid guiding path to the detection chip, and the body fluid guidance A detection chip member having a suction port communicating with the path , a puncture member mounting portion, a puncture start switch, and an elastic member for biasing the puncture member mounting portion, and for temporarily projecting the puncture needle A puncture needle drive mechanism, a suction mechanism with an electric pump for sucking a puncture site, a reduced pressure state release mechanism for releasing a reduced pressure state by the suction mechanism, and a state of the detection chip after contact with a body fluid A detection mechanism for leaving, a fluid status evaluator for evaluating the fluid state from the detection result by the detection mechanism, have a display mechanism for displaying the evaluation results of body fluid state evaluation mechanism, further, the lid member And an opening through which the fingertip can be inserted when the lid member is closed, and the opening can be pressed against the suction port of the detection chip member by the fingertip inserted through the opening. A bodily fluid testing device characterized by being formed . The bodily fluid test | inspection apparatus of Claim 1 which has a cover member sensor which detects opening and closing of the said cover member. The bodily fluid test | inspection apparatus of Claim 1 or 2 which has an accommodating part which can accommodate the said spare said puncture member and the said spare detection chip member inside the said cover member. The puncture member and the detection tip member constitute an integrated tip puncture needle assembly, and the tip puncture needle assembly includes the suction port that can be in close contact with a fingertip above the cutting edge of the puncture needle, and the body fluid humoral testing apparatus according to any one of the one end opening of the taxiway claims 1 other end projects into the suction port in which extends to the tip 3. The body fluid testing device includes a suction mechanism control mechanism that detects the operation of a puncture needle drive mechanism including the puncture start switch, activates the suction mechanism based on the detection result, and stops the operation of the suction mechanism. The bodily fluid test | inspection apparatus in any one of Claims 1 thru | or 4 .

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