HK1084571B - Humor sampling implement - Google Patents

Description

Body fluid collector

Technical Field

The present invention relates to a body fluid collection implement used by being attached to a component measurement device that can be used for measuring a blood glucose level and the like.

Background

In the prior art, in order to measure various components in blood, a method of measuring a reaction product of a specific mold which chemically reacts with a specific component in blood has been studied. In particular, measurement of blood glucose level is important for monitoring the state of a patient, and self-blood glucose measurement, i.e., monitoring of changes in daily blood glucose level by the patient himself or herself, has been recommended. In recent years, as the number of diabetic patients increases, a simple and less painful measurement method and a measurement apparatus have been demanded.

Such blood glucose measurement is often performed by a chemical reaction in which glucose is oxidized by an enzyme such as glucose oxidase or dehydrogenase, and is currently performed by a blood glucose measurement device that measures blood glucose by a colorimetric method or an electrode method. The colorimetric method is a method in which a test strip that develops color according to the amount of glucose in blood is attached, blood is supplied to the test strip, the blood is developed on the test strip to develop the test strip, and the degree of the color development is optically measured (color measurement), whereby the blood glucose level is quantified. The electrode method is to electrically measure the product of the above-mentioned enzymatic reaction.

In the colorimetric blood glucose level measurement, generally, the blood glucose level is measured after a chip (body fluid collection device) incorporating the test strip is mounted on a blood glucose measuring apparatus. The chip has a blood channel (body fluid transport channel) for collecting blood (body fluid) from the blood inlet and transporting the blood to the test strip by capillary action.

However, since the viscosity ratio of blood is high, blood may be retained in the blood passage. In particular, the blood stagnation is likely to occur in a portion of the blood channel close to the test strip (on the side opposite to the blood inlet) or in a portion of the blood channel where the direction of transport of the blood changes, and the blood stagnation occurs in the portion where the direction of transport of the blood changes. In this case, since the blood glucose level cannot be measured, the chip must be discarded, and the patient must collect blood again, which increases the burden.

Therefore, in japanese patent laid-open No. 2001-314394, for example, it has been proposed to solve the above-mentioned problem by using a chip in which a convex portion is provided at a portion where the direction of transport of blood in the blood channel changes, the convex portion being directed in the opposite direction to the transport of blood and facing into the blood channel. In this chip, the convex portion is provided to reduce a meniscus of blood column generated in the vicinity of the convex portion, and it is desired to smoothly carry blood by capillary phenomenon.

However, in this chip, the convex portion is provided on the side of the blood inflow port, and the problem that blood stays in a portion of the blood channel close to the test paper is not actually solved completely.

Disclosure of Invention

The invention aims to provide a body fluid collector which can reliably and quickly convey body fluid to a detection part.

In order to achieve the above object, the invention according to claim 1 is a body fluid collecting instrument comprising a main body and a detecting part,

the body portion having a body fluid transport channel for collecting blood from the body fluid inlet port and transporting it to the body fluid outlet port,

the detection unit is provided on the main body unit and detects a predetermined component in the body fluid transported through the body fluid transport channel,

the body portion is provided with a convex portion which overlaps the detection portion in a plan view and which protrudes into the body fluid transport channel toward the body fluid outlet.

This can prevent the cross-sectional area of the body fluid transport channel on the body fluid outflow port side from increasing, and as a result, can prevent the efficiency of body fluid transport from decreasing. Also, the cross-sectional area can be reduced, which can increase the efficiency of fluid transport. In addition, the meniscus that generates a blood column in the vicinity of the convex portion can be prevented or reduced well.

Therefore, the collected body fluid can be delivered to the detection section more reliably and quickly.

In the body fluid collector according to the present invention, the convex portion is preferably provided at a position corresponding to a substantial center of the detection portion.

In the body fluid collecting device of the present invention, the body fluid transfer path includes a first body fluid transfer path which opens to the body fluid inlet port and a second body fluid transfer path which is continuous with the first body fluid transfer path and in which the body fluid is transferred in a direction different from the transfer direction of the first body fluid transfer path,

the convex portion is preferably provided at an end portion of the main body portion on the side of the body fluid outflow port of the first body fluid transfer path, and protrudes into the second body fluid transfer path.

In the body fluid collecting device according to the present invention, it is preferable that the direction of transporting the body fluid in the first body fluid transporting path and the direction of transporting the body fluid in the second body fluid transporting path are substantially orthogonal to each other.

In the body fluid collecting device of the present invention, the volume of the convex portion is set to V₁[mm³]The volume of the second blood transport channel is set to V₂[mm³]Then, preferably, the relation: v₁/V₂＝0.04～0.7。

In the body fluid collecting device of the present invention, the projections are preferably subjected to hydrophilization treatment on the surfaces thereof.

In the body fluid collection device according to the present invention, it is preferable that the body fluid transport channel has a decreasing cross-sectional area portion whose cross-sectional area decreases toward the body fluid outlet port.

In the body fluid collecting device of the present invention, the minimum cross-sectional area of the gradually decreasing cross-sectional area is R₁[mm²]The maximum cross-sectional area is defined as R₂[mm²]When R is satisfied₁/R₂The relationship is 0.3 to 0.8.

In the body fluid collecting device according to the present invention, it is preferable that the gradually decreasing cross-sectional area is provided in the vicinity of the body fluid outlet port of the body fluid transport channel.

In the body fluid collector of the present invention, the main body preferably has a lower member and an upper member superposed on the lower member and constituting a part of the body fluid transporting path together with the lower member.

In the body fluid collector of the present invention, it is preferable that the body fluid collector includes a puncture needle having a sharp needlepoint at a tip thereof, and the puncture needle punctures the skin with the needlepoint to discharge the body fluid.

Drawings

Fig. 1 is a perspective view showing an embodiment of a chip (body fluid collector of the present invention).

Fig. 2 is an exploded perspective view of the chip shown in fig. 1.

Fig. 3 is a perspective view of the chip shown in fig. 1, viewed from below.

Fig. 4 is a sectional view a-a in fig. 1.

Fig. 5 is a cross-sectional view B-B of fig. 1.

Fig. 6 is a plan view showing a detection unit having the chip shown in fig. 1.

Fig. 7 is a cross-sectional view taken along line C-C of fig. 6.

FIG. 8 is a plan view showing a component measuring apparatus used after loading a chip (body fluid collecting instrument of the present invention).

FIG. 9 is a side view of the component measuring apparatus shown in FIG. 8.

Fig. 10 is a cross-sectional view taken along line X-X in fig. 8.

Fig. 11 is a cross-sectional view Y-Y of fig. 9.

Fig. 12 is a cross-sectional view Y-Y in fig. 9.

Fig. 13 is a diagram showing another configuration example of the second blood transfer channel (second body fluid transfer channel).

Detailed Description

Next, preferred embodiments of the body fluid collecting device and the body fluid collecting method according to the present invention will be described.

First, before the body fluid collecting device and the body fluid collecting method of the present invention are explained, a component measuring apparatus used after the body fluid collecting device of the present invention is loaded (mounted) will be explained. In the following description, as this component measurement device, a device that has a puncture device and can measure (detect) a predetermined component in a body fluid collected through the epidermis (skin) will be described as an example.

The site for collecting the body fluid in the epidermis (body fluid collection site) is preferably a finger, but may be a hand (palm, back of hand, side of hand), wrist, thigh, earlobe, or the like.

In the following, blood is taken as a body fluid, glucose is taken as a predetermined component, and fingertips (fingers) are taken as body fluid collection sites.

FIG. 8 is a plan view showing a component measuring apparatus used after loading a chip (body fluid collecting instrument according to the present invention), FIG. 9 is a side view of the component measuring apparatus shown in FIG. 8, FIG. 10 is a cross-sectional view taken along line X-X in FIG. 8, and FIGS. 11 and 12 are cross-sectional views taken along line Y-Y in FIG. 9. Hereinafter, the left side is referred to as the "front end" and the right side is referred to as the "base end" in fig. 8 to 12, and the upper side is referred to as the "upper" or "upper" and the lower side is referred to as the "lower" or "lower" in fig. 9 to 12.

The component measuring apparatus (blood glucose component measuring apparatus) 100 shown in each figure is a component measuring apparatus used after a chip (body fluid collecting device of the present invention) 1 is mounted thereon, and includes: the puncture device 500 includes a main body 200, a holding member 300 for accommodating and holding the puncture device 500, a pressing mechanism 700, an injection mechanism 800, a measurement device 900, a control device 1100 provided on a circuit board 1000, a display portion 1200, a micro switch 1300, and a battery (power supply portion) 1400. The following describes each constituent element.

The main body 200 has a box shape, and accommodates therein the holding member 300, the pressing mechanism 700, the injection mechanism 800, the measurement mechanism 900, the circuit board 1000 having the control device 1100, the display portion 1200, the micro switch 1300, and the battery (power supply portion) 1400.

On the front end surface 210 of the main body 200, an opening 230 penetrating the main body 200 is formed. The opening 230 is formed corresponding to the cross-sectional shape of the chip 1. The chip 1 is loaded (mounted) on the loading portion 310 through the opening 230, and the loading portion 310 is formed at the front end portion of the holding member 300. Thus, the chip 1 is loaded on the component measuring apparatus 100 (hereinafter, referred to as "loaded state").

On the right inner side surface (upper side surface in fig. 11 and 12) of the chip loading portion 310, a groove 311 is formed along the longitudinal direction. In this groove 311, when the chip 1 is mounted on the component measuring device 100, a flange member 9 formed on a base end portion of the housing 3 described later is inserted, and the groove 311 guides the flange member 9.

In addition, both sides of the main body 200 are gently curved, so that the component measuring apparatus 100 can be easily and reliably held.

A hole 250 is formed in the upper surface 220 of the main body 200, and an operation button 260 is provided in the hole 250.

The component measuring apparatus 100 is configured to operate a puncture device 500 described later by operating this button 260. Further, by pressing the operation button 260, the power of the component measuring apparatus 100 can be turned on.

Further, a display window (opening) 240 penetrating the inside and outside of the main body 200 is formed on the base end side of the upper surface 220 of the main body 200, and the display window 240 is closed by a plate-like member made of a transparent material.

A display unit 1200 is provided below (below) the display window 240. Therefore, various information displayed by the display unit 1200 can be confirmed through the display window 240.

The display unit 1200 is formed of, for example, a liquid crystal display element (LCD). On this display unit 1200, for example, on/off of the power supply, the power supply voltage (remaining battery level), a measurement value, a measurement date, an error display, an operation instruction, and the like can be displayed.

In addition, in a lower portion (lower portion) of the display portion 1200, a circuit board 1000 having a control device 1100 and a battery 1400 are provided.

The control device 1100 is constituted by, for example, a microcomputer, and determines whether or not blood is collected, and controls the respective operations of the component measuring device 100. In addition, an arithmetic unit is installed in the control device 1100, and the arithmetic unit calculates the amount of glucose (blood glucose level) in blood based on a signal from a measurement device 900 described later.

The battery 1400 is electrically connected to the measurement device 900, the control device 1100, the display unit 1200, and the micro switch 1300, respectively, and supplies electric power necessary for operation to them.

A measuring device 900 facing the chip loading portion 310 is provided above (above) the holding member 300. The measurement device 900 optically detects the blood supplied (collected) to the test strip (detection section) 73 of the chip 1, and optically measures the amount of glucose in the blood developed on the test strip 73. The measuring device 900 is formed of an optical member, and is provided at a position facing the test strip 73 (near the side of the test strip 73) in a state where the chip is loaded.

In this way, since the measurement device 900 has both a function of detecting collected blood and a function of measuring the amount of glucose in blood developed on the test strip 73, the number of components can be reduced, the structure can be simplified, and the number of man-hours for assembling the device can be reduced, as compared with a case where a device having these functions is separately provided.

The measurement device 900 includes a member body 910, a light emitting element (light emitting diode) 920 fixed to the member body 910, and a light receiving element (photodiode) 930.

The light emitting element 920 is electrically connected to the control device 1100, and the light receiving element 930 is electrically connected to the control device 1100 through an amplifier and an a/D converter, not shown.

The light emitting element 920 operates according to a signal from the control device 1100 and emits light. The emitted light is preferably pulsed light that intermittently emits light at predetermined time intervals.

When the light emitting element 920 is caused to emit light in a state where the chip is mounted, the light emitted from the light emitting element 920 is irradiated onto the test paper 73, and the reflected light is received by the light receiving element 930 and subjected to photoelectric conversion. An analog signal corresponding to the amount of received light is output from the light receiving element 930, amplified to a desired level by an amplifier, converted into a digital signal by an a/D converter, and input to the control device 1100.

In the control device 1100, it is determined whether or not blood has been collected, that is, whether or not blood has been developed on the test paper 73 of the chip 1, based on the input signal.

Further, the controller 1100 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. The obtained blood glucose level is displayed on the display unit 1200.

A pressing mechanism 700 and a microswitch 1300 facing the chip loading portion 310 are provided at the lower portion (lower portion) of the holding member 300.

In the state where the chip is loaded, the pressing mechanism 700 presses the chip 1 to position the chip with respect to the holding member 300. The pressing mechanism 700 is provided at a position facing a measurement device 900 to be described later via the chip loading unit 310.

The pressing mechanism 700 is provided in the hole 340 communicating with the chip loading portion 310 of the holding member 300, and is composed of a push rod 720 and a spring (urging member) 730 urging the push rod 720 upward.

On an outer peripheral portion of the middle portion of the push rod 720, a flange 740 as a spring seat is protrudingly formed. In a state where the chip is loaded, the tip end portion (upper end portion) of the pusher 720 can be inserted into the recess 36 of the chip 1 described later, whereby the chip 1 is favorably pressed toward the measuring apparatus 900 side.

The cover member 360 is fixed to the holding member 300 by screws 360a and 360b in order to seal the hole 340.

The spring 730 is in a compressed state, and both ends thereof abut against the inner surface of the cover member 360 and the flange 740, respectively, and load the push rod 720 in an upward direction.

As described above, although the push rod 720 is biased by the spring 730, the flange 740 is engaged with the step 370 formed in the hole 340, and therefore, the insertion of the push rod 720 into the chip mounting portion 310 is prevented from being below the step 370.

With the chip loaded, the positioning of the chip 1 with respect to the holding member 300 (component measuring apparatus 100) is completed by the pressing mechanism 700.

The micro switch 1300 detects whether or not the chip 1 is loaded in the chip loading unit 310.

The microswitch 1300 is provided in the hole portion 380 communicating with the chip loading portion 310 of the holding member 300, and the cover member 390 of the hole portion 380 is fixed to the holding member 300 by screws 390a and 390b, and the hole portion 380 is sealed in this manner.

Further, an injection mechanism 800 is provided inside the front end side (the vicinity of the opening 230 in the main body 200) of the holding member 300. The injection mechanism 800 is a member having a function of ejecting the chip 1 from the component measuring apparatus 100, and is composed of an injection pin 810 movable in the distal direction, and a moving rod (not shown) for moving the injection pin 810 in the distal direction.

In the state where the chip is loaded, the injection pin 810 is positioned inside the holder 300, and the tip thereof is in contact with a flange 39 of the chip 1 (see fig. 11) described later. From this state, by sliding operating the moving lever, the injection pin 810 moves in the front end direction inside the holding member 300 and pushes the flange 39 in the front end direction. Thus, the chip 1 moves in the front end direction with respect to the component measuring apparatus 100, and is detached from the chip loading unit 310 (component measuring apparatus 100).

As another configuration example, the following configuration may be adopted: an eccentric cam having a rotation shaft is disposed on the side forward of the front end of the holding member 300, and by rotating this eccentric cam, the flange 39 of the chip 1 is pressed in the front end direction.

Further, the puncture member 500 is accommodated and held in the holding member 300. In other words, the puncture member 500 is attached to the main body 200 of the component measurement apparatus 100 via the holding member 300. Therefore, the holding member 300 may be referred to as an attachment member (structural member) for attaching the puncture member 500 to the main body 200.

The puncture device 500 is a device that operates a puncture needle 5 (needle body 51) described later by puncturing the epidermis with a needle tip 511 thereof, and includes a plunger 510 and a spring (biasing member) 520 that biases the plunger 510 in the distal direction.

The push rod 510 is formed in a rod shape as a whole, and has a push rod main body 514 and a pair of arm portions 512. Each arm 512 is formed at the tip end of the plunger body 514 and is formed integrally with the plunger body 514.

The pusher body 514 is inserted into the support 580 and is movable within a predetermined range along the longitudinal direction thereof.

A recess 513 is formed on the inner surface of the tip end of each arm 512. In this recess 513, a connecting portion 524 of a puncture needle 5 described later is fitted, and the connecting portion 524 can be freely fitted into and removed from the recess 513. Thus, the puncture needle 5 is connected (connected) to the puncture device 500 in a state where the chip is loaded. That is, the arm portion 512 constitutes a support base 530 which connects and holds the puncture needle 5.

A flange 540 as a spring seat is formed to protrude from the middle portion of the push rod 510 in the longitudinal direction (near the boundary portion between the push rod 514 and the wrist portion 512).

In the state where the chip is loaded, the spring 520 is in a compressed state, and both ends thereof abut against the flange 540 and a part (not shown) of the holding member 300, respectively, thereby biasing the push rod 510 in the front end direction.

This state is maintained by the flange 540 being locked by the elastic piece 550 that can be elastically deformed (see fig. 11). One end 551 of the elastic piece 550 is fixed (fixedly attached) to the holding member 300, and the other end is used as a locking portion 552 locked to the flange 540, and the elastic piece 550 is displaced with the one end 551 as a fulcrum (fixed end) so that the locking portion 552 can move toward and away from the push rod 510 (shown by a two-dot chain line in fig. 11).

In this state, a space 560 is formed between the elastic sheet 550 and the holding member 300. When the lock releasing member 571 shown in fig. 10 is inserted into this space 560, the elastic piece 550 is elastically deformed to separate the lock portion 552 from the push rod 510. Thus, the flange 540 is released from the locking state by the elastic piece 550, and the push rod 510 is pushed by the spring 520 and moves in the distal direction (see fig. 12).

As shown in fig. 10, the unlocking member 571 is integrally formed with a plate-like member 570 that is supported in a cantilever manner with respect to the holding member 300, with one end 572 serving as a fixed end and the other end serving as a movable end. A pressing portion 573 is formed at the other end portion of the plate member 570 at a position corresponding to the operation button 260.

Further, a spring 574 is provided between the pressing portion 573 and the holding member 300.

When the operation button 260 is pressed, the pressing portion 573 of the plate member 570 is pressed downward, and the release locking portion 571 moves downward with the pressing portion and is inserted into the space 560. At this time, the spring 574 is in a compressed state, and the operation button 260 is biased upward by the pressing portion 573 of the plate member 570. Therefore, if the operation button 260 is released from being pushed, the operation button 260 is pushed upward by the spring 574 and the pushing portion 573 and moves, and returns to the position almost the same as the original position.

The chip 1 can be used by being mounted on the measurement device 100 as described above. The chip (body fluid collector of the present invention) 1 will be explained in detail below.

Fig. 1 is a perspective view showing an embodiment of a chip (body fluid collector of the present invention), fig. 2 is an exploded perspective view of the chip shown in fig. 1, fig. 3 is a perspective view of the chip shown in fig. 1 as seen from below, fig. 4 is a sectional view a-a of fig. 1, fig. 5 is a sectional view B-B of fig. 1, fig. 6 is a plan view showing a detection unit having the chip shown in fig. 1, and fig. 7 is a sectional view C-C of fig. 6. In the following description, the left side is referred to as the "front end" and the right side is referred to as the "base end" in fig. 1 to 7, and the upper side is referred to as the "upper" or "upper" and the lower side is referred to as the "lower" or "lower" in fig. 1, 2, 5, and 7. Note that fig. 1 and 6 show the test paper omitted.

The chip 1 shown in each figure includes a case 3 accommodating a puncture needle 5, and a detection unit 7 to which a test paper 73 is fixedly attached (fixed). Hereinafter, each constituent element will be described in turn.

The puncture needle 5 is composed of a needle body 51 and a hub 52 fixedly attached (fixed) to the needle body 51.

The needle body 51 is formed of a hollow member or a solid member made of a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy, and a sharp needle point (tip) 511 is formed at the tip of the needle body. When the tip 511 pierces the surface (skin) of a fingertip, a site to be pierced is bled (body fluid).

A bush 52 capable of projecting the needle tip 511 is fixed to the needle body 51 by, for example, fusion bonding, adhesion with an adhesive, fitting, caulking, or the like.

The bush 52 is composed of a cylindrical portion 53 having a substantially cylindrical shape at the distal end side and a rectangular parallelepiped portion 54 having a substantially rectangular parallelepiped shape at the base end. The outer diameter (diameter) of the columnar portion 53 is set to be substantially equal to the height of the rectangular parallelepiped portion 54.

A fitting portion 531 having an enlarged diameter with respect to the outer diameter of the cylindrical portion 53 is formed at the distal end portion of the cylindrical portion 53, and the fitting portion 531 is fitted to a fitting portion 35 of the housing 3 described later.

A pair of convex portions 541 protruding toward the side surfaces are formed at the distal end portion of the rectangular parallelepiped portion 54. Each of the projections 541 abuts against a step portion 34 of the housing 3 described later.

Further, a connecting portion 542 is formed at the distal end portion of the rectangular parallelepiped portion 54, and the shape of the connecting portion 542 corresponds to the shape of the support seat 530 of the push rod 510 described above. When the connection portion 542 is fitted (fitted) to the support seat portion 530 in a state where the chip is loaded, the puncture needle 5 is connected to the plunger 510 (puncture device 500).

The puncture needle 5 is provided in the cavity 33 having the housing 3 and is movable in the cavity 33. The housing 3 is formed of a substantially rectangular parallelepiped member, and has a front end opening 31 and a base end opening 32, which open to an inner cavity 33, formed at the front end and the base end, respectively. The needle body 51 of the puncture needle 5 protrudes from the distal end of the case 3 (chip 1) after passing through the distal end opening 31 (see fig. 12).

As shown in fig. 4, the inner cavity portion 33 is composed of a first inner cavity portion 331 on the distal end side and a second inner cavity portion 332 on the proximal end side.

The first inner cavity 331 is formed in a substantially cylindrical shape and has a cross-sectional area set to be substantially equal to or slightly larger than a cross-sectional area (maximum) of the fitting portion 531 of the bush 52. The second inner cavity 332 is formed in a substantially rectangular parallelepiped shape, and has a cross-sectional area set to be substantially equal to or slightly larger than the cross-sectional area (maximum) of the rectangular parallelepiped-shaped portion 54 (the portion of the projection 541).

When the puncture needle 5 moves relative to the housing 3, the fitting portion 531 of the hub 52 moves along the inner surface of the first inner chamber portion 331, and the portion of the convex portion 541 of the hub 52 moves along the inner surface of the second inner chamber portion 332. At this time, the fitting portions 531 and the convex portions 541 serve as support portions.

According to such a configuration, the puncture needle 5 is supported by the case 3 at two portions, i.e., the fitting portion 531 and the projection 541 of the bush 52, i.e., at two portions in the longitudinal direction of the puncture needle 5, when moving relative to the case 3. Therefore, the puncture needle 5 can move smoothly with respect to the housing 3, and at the same time, can move in the distal direction with high linearity while preventing the displacement thereof with respect to the housing 3. This can prevent the pain of the patient caused by the shaking of the needlepoint 511 of the needle body 51.

Further, since the shape of the first inner chamber portion 331 is different from the shape of the second inner chamber portion 332, a step portion 34 is formed at a boundary portion between the two inner chamber portions in the case 3. Therefore, if the puncture needle 5 moves in the distal direction, the convex portion 541 of the hub 52 abuts against the step portion 34. Then, the puncture needle 5 stops moving, and the length of the needle tip 511 of the puncture needle 5 protruding from the housing 3 is limited. That is, in the present embodiment, the projecting length limiting means is constituted by the stepped portion 34 formed in the housing 3 and the convex portion 541 formed in the hub 52 of the puncture needle 5 abutting against the stepped portion 34. By providing such a projection length regulating means, it is possible to prevent a finger (a portion from which body fluid is collected) from being pierced to a necessary depth or more.

Since both the fitting portion 531 and the convex portion 541 serving as the support portions are only partially in contact with the housing 3, the puncture needle 5 has a small frictional resistance when moving relative to the housing 3, and the movement is smoothly performed. Thus, the movement of the puncture needle 5 relative to the housing 3 is easily controlled.

Further, a fitting portion 35 having a diameter smaller than the inner diameter of the first inner cavity portion 331 is formed at the base end portion of the first inner cavity portion 331. The fitting portion 531 of the puncture needle 5 is fitted into the fitting portion 35. Thus, the puncture needle 5 is fixed with respect to the housing 3.

The fitting force (fixing force) between the fitting portion 35 and the fitting portion 531 is set to be larger than the force required to connect the connecting portion 542 of the puncture needle 5 to the support 530 of the puncture device 500 (plunger 510). This allows the puncture needle 5 to be smoothly connected to the puncture device 500.

The force required to fit the fitting portion 35 and the fitting portion 531 is set to be slightly larger than the force required to release the connection between the connecting portion 542 of the puncture needle 5 and the support base 530 of the puncture device 500. Thereby, the following operational effects can be obtained.

That is, in the chip 1 after use, the fitting portion 531 of the puncture needle 5 is located on the front end side of the fitting portion 35 of the case 3. From this state, if it is necessary to remove the chip 1 from the component measuring apparatus 100 and move the case 3 in the distal direction, the puncture needle 5 connected to the puncture device 500 is relatively moved toward the proximal side, and the fitting portion 35 and the fitting portion 531 are fitted to each other. At substantially the same time, or before and after, the connection between the connection portion 542 of the puncture needle 5 and the support base 530 of the puncture device 500 is released, and the chip 1 is detached from the component measuring apparatus 100. In this way, in the chip 1 detached from the component measuring apparatus 100, the fitting portion 35 is fitted to the fitting portion 531 substantially entirely or partially, and the puncture needle 5 is fixed to the housing 3. Therefore, even when the tip of the chip 1 is directed vertically downward, the protrusion of the needlepoint 511 of the puncture needle 5 from the tip of the case 3 is prevented, and even when the base end of the chip 1 is directed vertically downward, the removal of the puncture needle 5 from the case 3 is prevented. This can prevent damage to the skin by mistake, etc., and contamination of the surrounding environment by scattering of blood, etc., thereby improving safety.

Tapered portions 351 and 352 are formed at the distal end and the proximal end of the fitting portion 35 of the housing 3, respectively.

In the step of assembling the chip 1, the puncture needle 5 is inserted from the proximal end opening 32 of the case 3, and the fitting portion 531 of the hub 52 is fitted to the fitting portion 35 of the case 3, but these fitting operations can be easily performed by forming the tapered portion 352 in the proximal end portion of the fitting portion 35.

On the other hand, by forming the tapered portion 351 at the distal end portion of the fitting portion 35, as described above, when the chip 1 is removed from the component measuring apparatus 100, the fitting portion 531 of the bush 52 and the housing 3 can be fitted to each other more easily and reliably.

In addition, on the lower surface of the housing 3, a concave portion 36 and a rail groove (guide groove) 37 are formed in a recessed form, respectively.

In a state where the chip is loaded, this recess 36 is a portion into which the tip end portion of the pusher 720 (pressing mechanism 700) is inserted, and is formed in a shape corresponding to the shape of the tip end portion of the pusher 720.

The rail groove 37 is formed along the longitudinal direction of the housing 3 from the base end of the housing 3 to the vicinity of the recess 36. The guide rail groove 37 is a member having a function of guiding the tip end portion of the push rod 720 (pressing mechanism 700). By providing the guide groove 37, the front end portion of the push rod 720 can be smoothly and reliably guided by the concave portion 36.

The rail groove 37 has a cross-sectional shape corresponding to a longitudinal sectional shape of the tip end portion of the push rod 720.

Although the rail groove 37 may be formed continuously with the recess 36, in the present embodiment, a structure in which these are not continuous is adopted, and the bank portion 38 is formed between the rail groove 37 and the recess 36.

With this configuration, when the chip 1 is mounted on the component measuring apparatus 100, the tip end portion of the push rod 720 moves toward the concave portion 36 while being guided by the guide groove 37, and can reach the inside of the concave portion 36 while passing over the bank portion 38. At this time, since the chip 1 is reliably mounted on the chip mounting portion 310, the mounting is facilitated since the "click" is sensed.

Further, a pair of flanges 39 are formed on the front end portion of the housing 3 and on both side surfaces thereof. In the state where the chip is loaded, each flange 39 abuts against the front end of the main body 200 of the component measuring apparatus 100. When detaching the chip 1 from the component measuring apparatus 100, each injection pin 810 moves in the distal direction, and the distal end thereof abuts against the flange 39 and is pressed in the distal direction. Thus, the chip 1 is moved in the distal direction with respect to the component measuring apparatus 100, and is detached from the chip loading unit 310 (component measuring apparatus 100).

Further, a pair of wall portions 40, 41, and a boss 42 are formed on the upper surface of the housing 3 so as to face each other. The wall portion 40 is provided upright along both side portions of the front end side of the housing 3, and the wall portion 41 is provided upright on a middle portion of the housing 3 in the longitudinal direction and substantially orthogonal to the longitudinal direction. A detection unit 7 described later is attached to a portion surrounded by these wall portions 40 and 41. That is, this portion constitutes a detection unit mounting portion to which the detection unit 7 is mounted.

On the inner side of the wall portion 40, a pair of projections 42 are provided upright in contact with the wall portion 40. Each of the protrusions 42 is inserted into a recess 723 formed on the hood 72 of the detection unit 7. Thereby, the detection unit 7 is positioned and fixed with respect to the chip 1. In this state, the front end position of the detection unit 7 substantially coincides with the front end position of the housing 3.

The detection unit 7 is a member for detecting glucose (predetermined component) in blood (body fluid).

As shown in fig. 6 and 7, the detecting unit 7 includes a main body 70 and a test paper (detecting portion) 73 provided on the main body 70.

The main body 70 supports the test strip 73, and constitutes a part for attaching the detection unit 7 to the housing 3. The main body 70 is composed of a base (lower member) 71 and a cover (upper member) 72 stacked on the base 71.

The base 71 is formed of a member formed in a flat plate shape. A groove 711 opened to the upper surface is formed in this base 71. The groove 711 is formed substantially linearly along the longitudinal direction of the base 71. The groove 711 is open at the front end of the base 71.

The cover 72 is formed of a member formed in a substantially rectangular parallelepiped shape. A recess 724 is formed in the lower surface of the cover 72 along the longitudinal direction. The base 71 is fixedly mounted (fixed) in this recessed portion 724.

A test strip placement portion 721 for placing a test strip 73 is formed on the upper surface of the cover portion 72 and on the proximal end portion thereof. The test strip placement portion 721 is formed of a concave portion having a substantially circular shape (a planar shape corresponding to the test strip 73) in a plan view, and a through hole 722 communicating with the concave portion 724 is formed in a central portion of the bottom surface thereof.

In a state where the base 71 is fixed in the recess 724 of the cover 72, a blood transport channel (body fluid transport channel) 74 for transporting blood (body fluid) is constituted by a space formed (divided) therebetween and a through-hole 722 formed in the cover 72.

Examples of the method of fixing and attaching the base 71 and the cover 72 include welding (thermal welding, ultrasonic welding, and high-frequency welding), adhesion, and adhesion with an adhesive.

In addition, on both side surfaces of the hood 72, a pair of concave portions 723 are formed. The protrusions 42 of the case 3 are inserted into the respective recesses 723, and thereby the detection unit 7 is positioned and fixed with respect to the chip 1.

A recess is formed at the front end of the cover 72, and the front end of the groove 711 formed in the base 71 is exposed to the outside of the detection unit 7 in the recess. This recess constitutes a blood spot attachment portion 725 for attaching blood raised on the epidermis by puncture. By adhering blood to this blood spot adhering portion, blood is efficiently introduced into the blood transfer channel 74.

The test piece installation part 721 is composed of a concave part 751 for accommodating the test piece 73 and a concave part 752, and the concave part 752 is formed below (lower part) the concave part 751 and has a smaller diameter than the concave part 751. The through-hole 722 is formed in the bottom surface of the concave portion 752. The recess 751 has a tapered upper edge portion, and a plurality of seats 753 are erected on the bottom surface thereof and surround the outer periphery of the recess 752.

In the present embodiment, the pedestal portion 753 was formed in a substantially conical shape, and 9 were provided at substantially equal intervals along the outer periphery of the concave portion 752. In a state where the test sheet 73 is set on the test sheet setting portion 721, the pedestal portions 753 support the outer peripheral portion of the test sheet 73 near the top portion thereof, respectively.

On the bottom surface of the recess 752, a plurality of seats 754 are formed along the opening (blood outflow port 742) of the through-hole 722, and an annular groove 755 is formed at the boundary with the recess 751.

Each of the seats 754 is formed of a small cross-shaped piece provided at the opening of the through-hole 722, and is formed into a cone shape in which the height thereof gradually decreases outward.

Each of the pedestal portions 754 and 753 is a member having a function of supporting the test strip 73, and supports the test strip 73 near its center portion (a boss portion 731 of the test strip 73 described later) near its top portion.

According to such a configuration, in a state where the test strip 73 is set on the test strip setting portion 721, a relatively large gap 756 is formed (divided) between the lower surface of the test strip 73 and the upper surface of the test strip setting portion 721 (particularly, the concave portion 752). The gap 756 communicates with the blood transfer channel 74 through the space between the seats 754.

Such a gap 756 functions as an air discharge gap of the blood transfer channel 74, and prevents the collected blood from stagnating in the middle of the blood transfer channel 74 by the air pressure.

In addition, the gap 756 has a function of assisting (promoting) blood development on the test paper 73. That is, since the blood flowing out of the through-hole 722 (blood transfer channel 74) is supplied to the test strip 73 while being spread radially in the gap 756, the spread of the blood on the test strip 73 can be performed more rapidly and uniformly.

The blood transfer channel 74 has a blood inlet 741 open to the distal end of the detection unit 7, and a blood outlet 742 open to the upper portion (upper portion) of the detection unit 7.

The blood transfer channel 74 of the present embodiment is constituted by a first blood transfer channel (first body fluid transfer channel) 744 formed (divided) by the base 71 and the cover portion 72, and a second blood transfer channel (second body fluid transfer channel) 745 formed by the through-hole 722 communicating with the first blood transfer channel 744.

According to such a configuration, in which a part of the body fluid transport channel is formed by the base (lower member) 71 and the cover (upper member) 72, for example, the blood transport channel 74 having a long overall length and a small cross-sectional area can be formed relatively easily by a simple method, compared to a case where the entire blood transport channel 74 is formed by providing a small hole portion through a block-shaped member.

The first blood transport channel 744 is open to the blood inlet 741 and extends in the longitudinal direction of the detection unit 7, while the second blood transport channel 745 extends in the thickness direction of the detection unit 7 and is open to the blood outlet 742. That is, the blood transport direction (direction a in fig. 7) in the first blood transport channel 744 and the blood transport direction (direction B in fig. 7) in the second blood transport channel 745 are substantially orthogonal to each other. The blood outlet 742 opens to the substantially center of the test strip placement part 721 (test strip 73).

The blood that has contacted the blood spot adhesion portion 725 is introduced into the first blood transport channel 744 from the blood inlet 741, and is transported into the first blood transport channel 744 by capillary action. Then, the transport direction of the blood that has reached the boundary portion between the first blood transport channel 744 and the second blood transport channel 745 is changed by substantially 90 ° so that the blood follows the inner wall surface of the second blood transport channel 745; the blood is transported in the second blood transport channel 745 by capillary action in the second blood transport channel 745 so that the blood is raised to the blood outflow port 742. The blood flowing out of the blood outflow port 742 is supplied to the test strips 73 while spreading radially in the gap 756.

In the following description, the direction of transport of blood in the blood transport channel 74 is simply referred to as "transport direction", a cross section in a direction parallel to the transport direction of the blood transport channel 74 is referred to as "vertical cross section", and a cross section in a direction perpendicular to the transport direction is referred to as "transverse cross section".

In such a blood transfer channel 74, the shape, size, and the like of each part are preferably set as follows. The shape, size, and the like of the first blood transport channel 744 and the second blood transport channel 745 will be described below.

The cross-sectional area (average) of the first blood transport channel 744 is not particularly limited, but is preferably 0.05 to 30mm²About, especially 0.1 to 10mm²The right and left are more preferable. If the cross-sectional area (average) of the first blood transport channel 744 is too small, the blood transport by capillary phenomenon (hereinafter simply referred to as "blood transport") is slow, and it takes a long time to obtain a sufficiently large amount of blood, and on the other hand, if the cross-sectional area (average) of the first blood transport channel 744 is too large, the blood transport becomes difficult.

The cross-sectional shape of the first blood transport channel 744 may be rectangular, square, rhomboid, etc., triangular, hexagonal, octagonal, circular, oval, etc., but is preferably rectangular (as shown in fig. 2, the cross-sectional shape of the groove 711 is formed in the shape of コ). Thus, the amount of blood remaining in the first blood transport channel 744 may be made smaller.

From this viewpoint, the cross-sectional shape of the first blood transporting path 744, particularly a thin (low-height) rectangle, is preferable, and in this case, the height thereof is preferably about 0.05 to 0.5 mm; the width is preferably about 0.5 to 3mm, more preferably about 0.5 to 1 mm.

The length of the first blood transporting path 744 (total length: L1 in FIG. 7) is appropriately set in accordance with the cross-sectional area (average) of the first blood transporting path 744, and is not particularly limited, but is preferably about 1 to 25mm, more preferably about 5 to 20 mm.

On the other hand, the cross-sectional area (average) of the second blood transporting channel 745 is preferably 0.05 to 30mm for the same reason as that described for the first blood transporting channel 744²About, preferably 0.1 to 10mm²Left and right.

The cross-sectional shape of the second blood transport channel 745 is not particularly limited, and may be various shapes similar to the cross-sectional shape of the first blood transport channel 744.

In the present embodiment, the cross-sectional shape of the second blood transport channel 745 is formed to be substantially equal to the shape of the bottom of the projection 743 to be described later. Specifically, as shown in fig. 6, the shape is substantially circular.

As shown in fig. 7, the cross-sectional area of the second blood transport channel 745 is set to be substantially equal to the area of the bottom of the projection 743, and the cross-sectional area is substantially constant along the transport direction. That is, the second blood transport channel 745 is formed in a straight tube shape. With this configuration, even in the second blood transport channel 745 in which blood transport in the direction opposite to the weight direction is performed, efficient blood transport (blood is guided upward) can be realized.

The length (total length: L2 in FIG. 7) of the second blood carrying channel 745 is appropriately set according to the cross-sectional area (average) of the second blood carrying channel 745, but is not particularly limited, and is preferably about 0.1 to 1.0mm, more preferably about 0.4 to 0.8 mm.

The second blood transport channel 745 may be configured as shown in fig. 13. Fig. 13 is a diagram showing another configuration example of the second blood transfer channel (second body fluid transfer channel).

The second blood transport channel 745 shown in fig. 13 is formed in a shape in which the cross-sectional area gradually decreases toward the blood outlet 742, and constitutes a cross-sectional area gradually decreasing portion. This can facilitate blood transport, and thus can perform efficient blood transport.

In this case, if the minimum cross-sectional area of the second blood transport channel 745 is set to R₁[mm²]The maximum cross-sectional area is defined as R₂[mm²]When R is satisfied₁/R₂In the relationship of 0.3 to 0.8, it is more preferable that R is satisfied₁/R₂The relationship is 0.4 to 0.7. Thus, the effect of promoting blood transport in the second blood transport channel 745 is more significantly exertedAnd (5) fruit.

The present invention has such features: the main body 70 of the detection unit 7 is provided with a projection 743 projecting into the blood transport channel, and the projection 743 overlaps with the test strip 73 (is positioned directly below the test strip 73) and faces the blood outflow port 742 (test strip 73) in a plan view.

In the present embodiment, the projection 743 is provided on the bottom surface of the end portion (the boundary portion with the second blood transport channel 745) on the body fluid outflow port 742 side of the first blood transport channel 744 of the main body portion 70 (the base 71), and projects into the second blood transport channel 745.

By providing such a projection 743, it is possible to prevent the cross-sectional area from increasing on the blood outflow port 742 side of the blood transporting channel 74, or to reduce the cross-sectional area, and as a result, it is possible to prevent the efficiency of transporting blood from decreasing. The efficiency of blood transfer can be improved by reducing the cross-sectional area. Further, although the blood moves from the first blood transport channel 744 to the second blood transport channel after the space at the boundary portion between the first blood transport channel 744 and the second blood transport channel 745 is sufficiently filled with the blood, the provision of the projection 743 reduces the volume of the space at the boundary portion between the first blood transport channel 744 and the second blood transport channel 745, and the blood moves quickly. In addition, the meniscus of the blood column generated in the vicinity of this convex portion 743 can be preferably prevented or reduced. Therefore, the collected blood can be more reliably and quickly supplied to the test paper 73.

Therefore, the blood is not accumulated in the blood transfer channel 74 and discarded without using the chip 1, and the blood has to be collected again from the patient, so that the blood glucose level can be measured efficiently.

Here, if the volume of the recess 743 is set to V₁[mm³]The volume of the second blood transport channel 745 is set to V₂[mm³]Then, the relation is preferably satisfied: v₁/V₂0.04 to 0.7, more preferably, the following relationship is satisfied: v₁/V₂0.05 to 0.5. By mixing V₁/V₂Setting the range as described above can further improve the above-described effects.

The convex portion 743 is provided at a position corresponding to the blood outflow port 742 of the blood transporting channel 74, that is, a position substantially corresponding to the center of the test paper 73. This makes it possible to more smoothly carry out the blood supply to the test strip 73.

The projection 743 may have various shapes, but as shown in fig. 7, it is preferably a shape whose cross-sectional shape gradually decreases upward (for example, a shell shape or the like). In this way, the direction of transport from the first blood transport channel 744 to the second blood transport channel 745 can be changed well.

When the shape of the projection 743 is other shapes, the shape (vertical cross-sectional shape) may be a quadrangle such as a square, a diamond, or a trapezoid, a triangle, a hexagon, an octagon, a circle, or an ellipse.

It is preferable that the projections 743 are subjected to hydrophilization treatment on the surface thereof. This allows blood to be more quickly delivered to the blood outflow port 742 of the blood delivery channel 74.

The hydrophilization treatment may be carried out by adding (coating) a surfactant, water-soluble silicon, hydroxypropyl cellulose, polyethylene glycol, polypropylene glycol, or the like, in addition to physical activation treatment such as plasma treatment, glow discharge, corona discharge, ultraviolet irradiation, or the like.

From the above-described viewpoint, it is preferable that hydrophilic treatment be similarly performed on the inner surfaces of the first blood transporting channel 744 and the second blood transporting channel 745.

Such a projection 743 and base 71 can be obtained by: for example, (1): a method of forming in one piece by injection molding, (2): a method for forming a predetermined shape by performing etching on a base material, wherein (3): a method for forming a predetermined shape on a surface of a flat plate-like base material by a printing method, (4): a method of fixedly attaching (fixing) a member having a predetermined shape to a surface of a flat plate-like base material, and the like. According to the method (1) and the method (2), the convex portions 743 and the base 71 with high dimensional accuracy can be easily obtained, and further, according to the methods (3) and (4), the object of reducing the manufacturing cost of the convex portions 743 and the base 71 can be achieved. In addition, any two or more of the above methods (1) to (4) may be used in combination.

The test strip 73 is fixedly attached (fixed) to the test strip placement portion 721, the pedestal portion 753, and the pedestal portion 754 by, for example, welding or bonding with an adhesive.

The test strip 73 is a test strip capable of detecting glucose in blood transported through the blood transport path 74, and for example, the test strip 73 is formed by carrying (impregnating) a reagent (coloring reagent) on a carrier (absorbent body) capable of absorbing blood. The carrier is preferably formed of a porous membrane. In this case, the porous membrane preferably has a pore diameter close to the size of red blood cells in blood for filtering the red blood cells.

By using a carrier formed of a porous film, particularly in the case where the reagent impregnated in the carrier is a reagent system including a reaction process using oxygen as a base, such as an oxidase reaction, after blood is developed on the test paper 73, even in a state where the side receiving blood is covered with blood, oxygen in the atmosphere is supplied from the reaction side (opposite side), so that the reaction can be rapidly progressed, and the color development state can be detected without removing blood.

Examples of the support for the test sheet 73 include sheet-like porous substrates such as nonwoven fabrics, woven fabrics, and stretched sheets.

As the material constituting the carrier such as the porous film, polyesters, polyamides, polyolefins, polysulfones, celluloses, and the like can be cited, but since the carrier is immersed in an aqueous solution in which a reagent is dissolved or the blood is rapidly absorbed and developed at the time of blood collection, it is preferable that the carrier such as the porous film is made of a material having hydrophilicity or a material subjected to hydrophilization treatment by the same method as the above method.

The support body of the test sheet 73 may be formed of a single-layer sheet, or may have a multilayer structure in which a plurality of sheets are stacked.

In the illustrated configuration, the shape of the support of the test strip 73 in plan view is substantially circular, but may be in various shapes such as a rectangle, a rhombus, or other quadrangle, a triangle, a hexagon, an octagon, or an ellipse.

Examples of the reagent impregnated in the support (porous membrane) include a color former (color former) such as Glucose Oxidase (GOD), Peroxidase (POD), 4-aminoantipyrine and N-ethyl N- (2-hydroxy-3-sulfopropyl) -m-toluidine when measuring the blood glucose level, and examples of the measurement component include a reagent reacting with a blood component (predetermined component) such as ascorbate oxidase, alcohol oxidase, enzyme dehydrogenase, galactose oxidase, fructose dehydrogenase, cholesterol oxidase, cholesterol dehydrogenase, lactate oxidase, lactate dehydrogenase, bilirubin oxidase, and xanthine oxidase, and a color former (color former) similar to the above. Further, a buffer such as a phosphate buffer may be contained. As for the kind and composition of the reagent, it is needless to say that they are not limited thereto.

Further, a convex portion 731 is formed near the center portion of the test paper 73. In a state where the test strip 73 is set on the test strip setting portion 721, the projection 731 abuts against and is supported by each of the pedestal portions 754. This makes it possible to fix the test strip 73 to the test strip placement portion 721 more stably, and to prevent unevenness in spreading of blood on the test strip 73 due to deformation (bending, deflection, pleating, etc.) of the test strip 73.

A lid 8 is attached to the tip end portion of the chip 1 to close the inner cavity 33 of the case 3. The cover 8 is attached to the chip 1 before use (unused chip 1), and is detached when the chip 1 is used. The lid 8 has a body 81 and a fitting portion 82.

The fitting portion 82 is formed in a substantially cylindrical shape, and has an outer diameter set substantially equal to or slightly larger than the inner diameter of the first inner chamber portion 331 of the housing 3.

The fitting portion 82 is inserted into and fitted to the front end portion of the first inner cavity portion 331 of the housing 3. Thereby, the lid 8 is mounted on the case 3 (chip 1). Further, the edge portion of the proximal end portion of the fitting portion 82 is tapered, so that the fitting portion 82 can be more easily inserted into the first inner cavity portion 331 of the housing 3.

When the chip 1 is not used, the fitting portion 35 of the housing 3 and the fitting portion 531 of the hub 52 (puncture needle 5) are fitted to each other, and if the fitting portion 82 of the lid 8 is fitted to the distal end portion of the housing 3, the first inner chamber portion 331 of the housing 3, that is, the inner chamber portion 33 of the housing 3 where the needlepoint 511 of the needle body 51 (puncture needle 5) is located is structurally secured. Thereby, entry of bacteria into the first inner chamber portion 331 is prevented. Therefore, the sterilized state by the sterilization treatment performed on the chip 1 is maintained before the cover 8 is detached from the chip 1.

Here, the term "ensuring the sealing property of the inner chamber 33" means that bacteria cannot enter the inner chamber 33 in practice, and the inner chamber 33 is preferably ensured to be airtight, but the airtightness is not necessarily ensured, and may be so high as to exhibit the above-described effects.

Between the body 81 and the fitting portion 82, a diameter-enlarged portion 83 having an enlarged diameter with respect to the outer diameter of the fitting portion 82 is formed. When the lid 8 is mounted on the chip 1, the base end surface of the enlarged diameter portion 83 abuts the front end surface of the case 3, and the position of the lid 8 with respect to the chip 1 is determined.

The main body 81 is substantially triangular in plan view, and is a portion to be gripped by fingers or the like when the lid 8 is attached to the case 3.

A projection 811 is formed at the center of the body 81, and the projection 811 projects toward the surface to be gripped by a finger or the like. The convex portion 811 has a function of preventing sliding when the body 81 is gripped, that is, the convex portion 811 is a member constituting an anti-slip member. By providing this projection 811, the main body 81 can be reliably gripped by fingers or the like, and the attachment/detachment operation of the lid 8 to/from the case 3 (chip 1) can be more reliably performed.

Further, the lid 8 is formed with a hole 84 extending from the base end to the middle of the body 81 along the longitudinal direction thereof. The hole portion 84 serves as a space for accommodating at least the needlepoint 511 of the needle body 51 (puncture needle 5), and is formed so that the center axis of the hole portion 84 substantially coincides with the center axis of the needle body 51. Thus, even if the puncture needle 5 is accidentally moved in the distal direction (when the discharge occurs due to a mistake) in a state where the cover 8 is attached to the case 3, the needle body 51 is accommodated in the hole portion 84, and therefore, the needle tip 511 is prevented from being deformed and damaged. Therefore, by returning the pin body 51 to the state in which the fitting portion 531 of the bush 52 and the fitting portion 35 of the housing 3 are fitted to each other, the original state can be returned to the unused state, and the number of chips 1 discarded without being used can be reduced.

The components described above include: the hub 52, the housing 3, the base 71 (including the projection 743), the cover 72, and the cover 8 of the puncture needle 5 are made of the following materials: for example, thermoplastic resins such as ABS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethyl methacrylate, polyethylene oxide, fluororesin, polycarbonate, polyamide, acetal resin, acrylic resin, and polyethylene terephthalate, and thermosetting resins such as phenol resin, epoxy resin, silicone resin, and unsaturated polyester. In addition, various ceramic materials, various metal materials, and the like can be used for these structural materials.

Further, such a chip 1 has a mismounting prevention device for preventing mismounting of the chip 1 when the chip 1 is mounted on the component measuring apparatus 100. This makes it possible to prevent the component measuring apparatus 100 from malfunctioning. This erroneous mounting prevention device will be described in detail below.

A flange member 9 is formed to protrude from a base end portion of the case 3 of the chip 1 and on one side surface (right side surface) thereof. On the other hand, a groove 311 is formed along the longitudinal direction of the inner surface (right inner surface) of the chip loading portion 310 of the component measuring apparatus 100. When the chip 1 is mounted on the component measuring apparatus 100, the flange member 9 is guided by the groove 311.

Therefore, if the chip 1 is misaligned in the vertical direction and is to be mounted on the component measuring apparatus 100, the chip 1 cannot be mounted (mounted) on the chip mounting portion 310 because the groove 311 for inserting the flange member 9 is not provided.

As described above, the front end of the case 3 is provided with the protruding walls 40 and 41, the bump 42, and the flange 39, so that the chip 1 and the case 3 have a shape on the front end side and a shape on the base end side that are greatly different from each other.

Therefore, if the chip 1 is mistaken for the front-back direction and the vertical direction and is to be mounted on the component measuring apparatus 100, the chip 1 cannot be mounted (mounted) on the chip mounting portion 310 because the shape of the front end side of the housing 3 is different from the shape of the base end side.

Thus, by configuring the erroneous mounting prevention device such that the shape of the distal end side of the housing 3 is different from the shape of the proximal end side, it is possible to prevent an increase in the number of parts of the chip 1 and an increase in the manufacturing cost.

In addition, when the detection unit 7 is used as a device for measuring blood glucose as in the present embodiment, although there are patients with significant visual deterioration due to complications among diabetic patients, since such a misloading prevention device is provided on the chip 1, the chip 1 can be accurately and conveniently loaded into the component measuring device 100 even for patients with significant visual deterioration.

Next, a method (action) of using the chip 1 after being loaded in the component measuring apparatus 100, that is, an example of a blood collection method (body fluid collection method of the present invention) will be described.

[1] First, the chip 1 is inserted into the chip loading portion 310 of the holding member 300 through the opening of the body 200, and the connection portion 542 of the puncture needle 5 is fitted to the support 530 of the plunger 510. This connects the puncture needle 5 and the puncture device 500.

Further, if the chip 1 is pushed in the proximal direction, the pusher 510 moves in the proximal direction against the elastic force of the spring 520.

Here, in the state before the chip 1 is inserted, the flange 540 of the pusher 510 is positioned at the tip side of the locking portion 552, but if the pusher 510 moves in the proximal direction, the edge of the flange 540 comes into contact with the tip surface (inclined surface) of the locking portion 552 and presses it in the direction away from the pusher 510. Thus, the elastic piece 550 is deformed, the locking portion 552 moves, and the flange 540 moves toward the proximal end side beyond the locking portion 552.

As a result, even if the pushing force in the proximal direction of the pusher 510 by the chip 1 is released, the flange 540 is locked to the locking portion 552, and therefore, the movement of the pusher 510 in the distal direction is restricted. In addition, at this time, the spring 520 is in a compressed state.

If the chip 1 is pushed in the proximal direction, the proximal end of the flange 540 abuts the distal end of the support 580, and thus the movement of the pusher 510 in the proximal direction is prevented from exceeding the distal end of the support 580. In this way, the puncture needle 5 is prevented from moving in the proximal direction, but the fitting between the fitting portion 531 of the puncture needle 5 and the fitting portion 35 of the housing 3 is released by the movement of the housing 3 in the proximal direction.

At substantially the same time, the tip of the pusher 720 of the pressing mechanism 700 is inserted into the recess 36 of the chip 1. In this way, in the chip loading section 310, the chip 1 is positioned at an appropriate position, and the position of the test strip 73 with respect to the measuring apparatus 700 is also set at an appropriate position.

In such a state (i.e., the state in which the chip is loaded), preparation for puncturing with the puncture needle 5 and preparation for collecting blood (body fluid) are completed. Then, the cover 8 mounted on the chip 1 is detached.

[2] Next, at substantially the same time as the chip 1 is mounted, the components of the component measuring apparatus 100 are started up by turning on the micro switch 1300, and the component measuring apparatus 100 is in a state in which measurement is possible.

[3] Then, a fingertip (finger) is placed on the tip of the chip 1 and pressed. In this state, the puncture device 500 is operated by pushing the operation button 260.

First, in conjunction with the pressing operation of the operation button 260, the release locking member 571 also moves downward and is inserted into the space 560. Thus, the locking portion 552 moves in a direction away from the plunger 510, and the locked state of the plunger 510 by the locking portion 552 is released.

At this time, the spring 520 in a compressed state moves the push rod 510 in the front end direction due to its elastic force. The push rod 510 moves in the distal direction, so that the puncture needle 5 moves in the distal direction, and the needlepoint 511 of the needle body 51 protrudes from the distal end of the chip 1 through the distal opening 31 of the case 3, thereby puncturing the skin (surface) of the fingertip.

In this case, in the chip 1, the hub 52 of the puncture needle 5 is supported by the case 3 at two positions (fitting portion 531 and projection 541) and moves thereon. Therefore, the shaking of the puncture needle 5 relative to the housing 3 is effectively corrected, and the puncture needle 5 is moved in the front end direction with high linearity. Therefore, it is preferable to prevent the pain of the patient when the needlepoint 511 of the needle body 51 is shaken.

The puncture device 500 is provided with a spring (not shown) that presses and returns the plunger 510 in the proximal direction, and this spring presses the plunger 510 in the proximal direction to return to the original position after the fingertip puncture with the puncture needle 5. The plunger 510 repeats the movement in the distal direction and the movement in the proximal direction by the elastic force of the spring 520 and the elastic force of the spring for pushing and returning, and finally rests at a position where the elastic force of the spring 520 and the elastic force of the spring for pushing and returning are balanced. At this time, the needlepoint 511 of the needle body 51 is accommodated in the chip 1. Thus, the needle tip 511 of the needle body 51 does not protrude from the tip of the chip 1 except during the puncture, and the safety is high without accidentally injuring the skin or the like.

[4] When the puncture is made, the component measuring apparatus 100 with the chip 1 loaded (mounted) is placed on a table or the like, and then the periphery of the puncture site of the fingertip punctured with the puncture needle 5 is kneaded with another finger or the like, so that blood flows out from the puncture site.

[5] Then, the component measuring apparatus 100 is gripped again, and the blood raised at the puncture site is brought into contact with the blood spot adhesion portion 725 of the chip 1 in accordance with the operation of [4 ].

If blood comes into contact with the blood spot attaching portion 725, the blood is introduced into the first blood transporting path 744 from the blood inlet 741, and transported in the first blood transporting path 744 by capillary action. Then, the blood transported in the first blood transport channel 744 sufficiently fills the space at the boundary between the first blood transport channel 744 and the second blood transport channel 745, and thereafter, rises toward the blood outflow port 742 by the capillary phenomenon in the second blood transport channel 745.

At this time, since the projection 743 projecting in the axial direction of the second blood transport channel 745 (in the blood transport direction) is provided on the bottom surface of the end portion of the first blood transport channel 744 on the second blood transport channel 745 side, the space at the boundary portion between the first blood transport channel 744 and the second blood transport channel 745 is quickly filled with blood, and the blood quickly moves into the second blood transport channel 745 and rises toward the blood outflow port 742.

The blood transported in the second blood transport channel 745 is supplied to the test strip placement portion 721 through the blood outflow port 742, and is supplied to the test strips 73 while being radially expanded in the gap 756.

If blood is supplied to the test strip 73, glucose in blood glucose reacts with the reagent in the test strip 73 and develops color according to the amount of glucose.

[6] The color of the test piece 73 is detected by the measuring apparatus 900. In the measurement device 900, light from the light emitting element 920 is irradiated onto the test piece 73, and the reflected light is received by the light receiving element 930 and photoelectrically converted. Then, an analog signal corresponding to the amount of received light is output from the light receiving element 930, amplified to a desired level, converted into a digital signal by an a/D converter, and input to the control device 1100.

[7] The controller 1100 performs predetermined arithmetic processing based on the digital signal, and performs correction such as temperature correction calculation and blood red blood cell density value correction calculation as necessary to obtain the amount of glucose in blood (blood glucose level). That is, the blood glucose level is quantified. Then, the obtained blood glucose level is displayed on the display unit 1200. This makes it possible to grasp the blood glucose level.

According to such a method, 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 blood) can be measured accurately with a small amount of blood.

[8] Next, if the injection mechanism 800 is operated, the injection pin 810 moves in the front end direction and pushes the flange 39 in the front end direction. Thus, the chip 1 is moved in the distal direction with respect to the component measuring apparatus 100, and is detached from the chip loading unit 310 (component measuring apparatus 100).

At this time, if the housing 3 moves in the distal direction, the puncture needle 5 connected to the puncture device 500 moves relatively toward the proximal end side, and the fitting portion 35 and the fitting portion 531 are fitted to each other. At substantially the same time, or before and after, the connection between the connection portion 542 of the puncture needle 5 and the support seat portion 530 of the puncture device 500 is released.

In this way, in the chip 1 detached from the component measuring apparatus 100, almost the whole or a part of the fitting portion 35 and the fitting portion 531 is fitted, and the puncture needle 5 is fixed to the housing 3.

[9] Then, the cover 8 is attached to the tip end portion of the chip 1 as necessary, and the chip 1 is discarded.

The body fluid collection device and the body fluid collection method according to the present invention have been described above with reference to the illustrated embodiments, but the present invention is not limited to the above embodiments.

The structure of each part of the body fluid collector of the present invention can be replaced with any structure capable of exhibiting the same function.

For example, although the puncture needle-integrated body fluid collection device in which the puncture needle and the detection unit are integrated has been described as an example in the above embodiment, the body fluid collection device according to the present invention may be a body fluid collection device configured without the puncture needle and its peripheral components, that is, only the detection unit as described above.

In the above embodiment, the second bulk fluid transfer passage has a configuration in which the cross-sectional area is gradually reduced, but the gradually reducing portion may be provided in the first bulk fluid transfer passage or in both the first and second bulk fluid transfer passages. That is, the decreasing cross-sectional area portion may be provided at any position of the bodily fluid transport channel. Further, the whole body fluid transport channel may be constituted by a cross-sectional area decreasing portion.

For example, in the above-described embodiment, the puncture needle is supported by the case at two points in the longitudinal direction thereof when moving relative to the case, but in the present invention, the puncture needle may be supported by the case at three or more points. Thus, the straightness of the puncture needle is further improved.

In the above-described embodiment, the body fluid transport path is constituted by two transport paths, but the body fluid transport path may be constituted by one or 3 or more transport paths.

The body fluid transport channel is not limited to the channel that has been bent as described above, and may be a channel that is bent at a point in the body fluid transport direction.

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

In the above-described embodiment, the component to be measured is exemplified by glucose (blood sugar), but in the present invention, the component to be measured is not limited thereto, and may be, for example, various sugars, cholesterol, lactic acid, hemoglobin (occult blood), uric acid, creatinine, various proteins, inorganic ions such as sodium, and the like.

In the above-described embodiment, the measurement method is described as an example of a method of measuring the amount of a predetermined component, but in the present invention, the measurement method may be a method of measuring the property of a predetermined component, or may be a method of measuring both the amount and the property of a predetermined component.

In the above-described embodiment, the detection part develops color (develops color) by a reaction between a predetermined component in a body fluid and a reagent, that is, a case where the detection part is applied to a method (colorimetric method) of optically detecting the predetermined component has been described, but in the present invention, the detection part may be applied to an electrode method (a method of electrically detecting the predetermined component). In this case, an electrode is provided on the detection part, and as a reagent that reacts with a predetermined component, a combination of at least one oxidoreductase and at least one electron acceptor such as potassium ferricyanide, a ferrocene derivative, a quinone derivative, or a metal complex, among the aforementioned enzymes, can be used.

According to the body fluid collector and the body fluid collecting method of the invention, collected body fluid can be more reliably and rapidly conveyed to the detection part. Therefore, the body fluid is not retained in the body fluid transporting path, the body fluid collector is not discarded without use, and it is unnecessary to collect the body fluid again from the patient, so that the component measurement can be performed efficiently. Further, the above-described effects are preferably exhibited by a simple structure in which the convex portion is provided without using any special device, and therefore, the present invention can be applied to a disposable article while achieving the object of reducing the manufacturing cost. Therefore, the present invention can be industrially used.

Claims (7)

1. A body fluid collector, characterized by: comprises a main body part and a detection part,

the body portion has a body fluid transfer channel for collecting body fluid from the body fluid inlet port and transferring the collected body fluid to the body fluid outlet port,

the detection unit is provided on the main body unit and detects a predetermined component in the body fluid transported through the body fluid transport channel,

the body portion is provided with a convex portion which overlaps the detection portion in plan view and which protrudes into the body fluid transport channel in a direction toward the body fluid outflow port.

2. A body fluid collector as claimed in claim 1, wherein: the convex portion is provided at a position corresponding to a substantial center of the detection portion.

3. A body fluid collector as claimed in claim 1 or 2, wherein:

the body fluid transfer path has a first body fluid transfer path which opens to the body fluid inlet, and a second body fluid transfer path which is continuous with the first body fluid transfer path and in which the body fluid is transferred in a direction different from the direction in which the body fluid is transferred in the first body fluid transfer path,

the convex portion is provided at an end portion of the main body portion on the side of the body fluid outflow port of the first body fluid transfer path, and protrudes into the second body fluid transfer path.

4. A body fluid collector as claimed in claim 3, wherein: the body fluid transport direction in the first body fluid transport path and the body fluid transport direction in the second body fluid transport path are substantially orthogonal to each other.

5. A body fluid collector as claimed in claim 3, wherein: the volume of the convex part is set as V₁[mm³]The volume of the second blood transport channel is set to V₂[mm³]And then, satisfy the relational expression: v₁/V₂＝0.04～0.7。

6. A body fluid collector as claimed in claim 1, wherein: the body portion has a lower member and an upper member superposed on the lower member and forming a part of the bodily fluid transport channel together with the lower member.

7. A body fluid collector as claimed in claim 1, wherein: the body section has a lower member and an upper member, the upper member being superposed on the lower member and forming a part of the body fluid transfer path together with the lower member, the body fluid transfer path having a first body fluid transfer path opening to the body fluid inflow port and a second body fluid transfer path continuous with the first body fluid transfer path, and a transfer direction of the body fluid of the second body fluid transfer path being substantially orthogonal to the transfer direction of the body fluid in the first body fluid transfer path,

the convex portion is provided at an end portion of the main body portion on the side of the body fluid outflow port of the first body fluid transfer channel and protrudes into the second body fluid transfer channel, and the convex portion is provided at a position corresponding to a substantial center of the detection portion,

the volume of the convex part is set as V₁[mm³]The volume of the second blood transport channel is set to V₂[mm³]And then, satisfy the relational expression: v₁/V₂＝0.04～0.7。