JP5376429B2 - Analytical device, analytical apparatus and analytical method using the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an analyzing device capable of sampling a specimen liquid directly and feeding it inside. <P>SOLUTION: The analyzing device is characterized in that a capillary cavity 19 and an injection port 13 protruded from the axis 43 toward the outer circumference are connected by a guide portion 17 which is formed to extend toward the inner circumference, and on which a capillary force acts, thereby feeding a specimen liquid sampled from the leading end of the injection port 13 to a separation cavity 23, and in that a bent portion 22 and a recess 21 are formed at the connected portion between the guide portion 17 and the capillary cavity 19, thereby changing the direction of the passage. <P>COPYRIGHT: (C)2009,JPO&amp;INPIT

Description

  The present invention relates to an analysis device used for analyzing a liquid collected from a living organism, and an analysis apparatus and analysis method using the same, and more specifically, allows an analysis device to directly collect a sample liquid. Regarding technology.

  Conventionally, as a method for analyzing a liquid collected from a living organism or the like, a method for analyzing using a device for analysis in which a liquid channel is formed is known. The analytical device can control the fluid using a rotating device, and utilizes centrifugal force to dilute the sample liquid, measure the solution, separate the solid component, transfer and distribute the separated fluid, Since a solution and a reagent can be mixed, various biochemical analyzes can be performed.

  As shown in FIG. 30, an analytical device 50 that transfers a solution using centrifugal force injects a sample liquid from an injection port 51 into a measuring chamber 52 using an insertion instrument such as a pipette. After holding the sample solution with the capillary force of 52, the sample solution is transferred to the separation chamber 53 by the rotation of the analyzing device. An analytical device that uses such centrifugal force as a power source for liquid feeding can be used as a preferred shape because microchannels for liquid feeding control can be arranged radially by using a disk shape, and no wasted area is generated. It is done.

Further, as shown in FIG. 31, the analyzing device 54 described in Patent Document 2 collects a sample solution from an inlet 55 so as to fill the first cavity 56 by capillary action, and the axial center of the analyzing device 54. The sample liquid in the first cavity 56 is configured to be transferred to the separation cavity 58 by rotating around 57, and the sample liquid can be collected directly from the injection port 55, so that an insertion instrument such as a pipette is not required. It has the merit that the sample solution can be injected into the analytical device by a simple operation.
JP 7-500910 (Fig. 1) JP-T-4-504758 (FIG. 3)

  However, Patent Document 1 has a problem that work efficiency at the time of supplying the sample liquid is poor because the sample liquid cannot be directly collected. Further, in Patent Document 2, although the sample liquid can be directly collected, the rotation radius becomes large because the analysis device does not have an axis, and the analysis apparatus becomes larger and the load on the apparatus increases. Have.

  SUMMARY OF THE INVENTION An object of the present invention is to provide an analysis device that can directly collect a sample solution and supply it to the inside, and an analyzer that can be reduced in size as compared with the prior art.

  The analysis device according to claim 1 of the present invention is a micro that rotates around an axial center set inside thereof and transfers a sample solution toward the internal measurement spot by centrifugal force accompanying the rotation. An analytical device having a channel structure and used for reading to access a reaction solution at the measurement spot, which protrudes from the axial center in the outer peripheral direction and collects a sample solution from the tip, and from the injection port An inductive portion with capillary force formed extending in the inner circumferential direction, a capillary cavity capable of holding a necessary amount of sample liquid collected from the inlet through the inductive portion by the capillary force, and the capillary cavity. A receiving cavity for receiving the sample liquid to be transferred, and a recess is formed in the connecting portion between the guide portion and the capillary cavity to change the direction of the passage. Characterized in that the formation of the bent portion.

The analyzing device according to claim 2 of the present invention is characterized in that, in claim 1, a protective cap for holding the sample liquid scattered from the guiding portion is provided outside the injection port.
The analysis device according to claim 3 of the present invention is characterized in that, in claim 1, a cavity opened to the atmosphere is formed on the side of the base portion, the bent portion, and the capillary cavity of the guide portion. To do.

  The analysis device according to claim 4 of the present invention is characterized in that, in claim 3, the cross-sectional shape orthogonal to the flow direction of the guiding portion is formed by an inclined surface that gradually narrows toward the back end. To do.

  The analysis device according to claim 5 of the present invention is the analysis device according to claim 1, wherein the bent portion is formed on the same circumference as the capillary cavity with respect to the axial center or at an inner circumferential position with respect to the capillary cavity. It is characterized by that.

  The analysis apparatus according to claim 6 of the present invention is an analysis apparatus in which the analysis device according to claim 1 that has collected the sample liquid is set, and is a rotation driving unit that rotates the analysis device around an axis. And analysis means for accessing and analyzing the reactant in the analysis device based on the solution transferred by the rotation driving means, and the sample liquid in the capillary cavity is received by the rotation of the rotation driving means. It is configured to be transferred to the cavity.

  An analysis method according to claim 7 of the present invention is an analysis method using the analysis device according to claim 1, wherein the analysis device is centered on an axis set inside the analysis device. Rotating the sample liquid spotted on the inlet of the analytical device at the bent portion and transferring only the sample liquid held in the capillary cavity to the receiving cavity; and the transferred sample It comprises a step of mixing a reagent with at least a part of a liquid, and a step of accessing a reaction product of the measurement spot at a timing when the measurement spot is interposed at a reading position.

According to an eighth aspect of the present invention, there is provided an analytical device that is driven to rotate around an axial center set therein, and that transports a sample liquid toward the internal measurement spot by centrifugal force accompanying the rotational drive. An analytical device having a channel structure and used for reading to access a reaction solution at the measurement spot, which protrudes from the axial center in the outer peripheral direction and collects a sample solution from the tip, and from the injection port An inductive portion with capillary force formed extending in the inner circumferential direction, a capillary cavity capable of holding a necessary amount of sample liquid collected from the inlet through the inductive portion by the capillary force, and the capillary cavity. and a receiving cavity for receiving the sample liquid to be transported, as well as connecting the receiving cavity in the measurement spot, before beginning of the induction portion To the formation of the liquid reservoir that temporarily holds before the sample liquid suction into the induction unit characterized.

The analysis device according to claim 9 of the present invention is characterized in that, in claim 8, a bent portion is formed in the connecting portion between the guide portion and the capillary cavity to change the direction of the passage. And

  The analysis device according to claim 10 of the present invention is characterized in that, in claim 8 or claim 9, a filter is provided in the liquid reservoir.

  According to this configuration, the sample solution can be directly collected and supplied to the inside without using an insertion tool, so that the user's work efficiency can be improved. In addition, the analyzer can be downsized and the load can be reduced.

  In addition, in the case of an analytical device in which a liquid reservoir that temporarily holds the sample liquid before being sucked into the induction portion is formed at the start end of the induction portion, the liquid reservoir even if the injection port is separated from the fingertip after spotting. Since the sample liquid held in the chamber is automatically sucked into the analysis device through the induction unit, the operability for the user is improved, and a fixed amount of sample liquid can be taken in reliably. Improve accuracy.

Hereinafter, embodiments of an analysis device, an analysis apparatus using the analysis device, and an analysis method according to the present invention will be described with reference to FIGS.
(Embodiment 1)
1 to 6 show the analysis device of the first embodiment.

  FIGS. 1A and 1B show a state in which the protective cap 2 of the analysis device 1 is closed and opened. FIG. 2 shows an exploded state with the lower side in FIG. 1 (a) facing upward, and FIG. 3 shows an assembly drawing thereof.

  This analytical device 1 shown in FIG. 1 and FIG. 2 includes a base substrate 3 having a microchannel structure having fine irregularities on its surface, a cover substrate 4 that covers the surface of the base substrate 3, and a diluent. Are composed of four parts including a diluent container 5 that holds a protective cap 2 and a protective cap 2 for preventing sample liquid scattering.

The base substrate 3 and the cover substrate 4 are joined with the diluent container 5 and the like set therein, and the protective cap 2 is attached to the joined substrate.
By covering the openings of several concave portions formed on the upper surface of the base substrate 3 with the cover substrate 4, a plurality of storage areas described later (same as measurement spots described later) and the microchannels connecting the storage areas are connected. A flow path having a structure is formed. Necessary ones of the storage areas are loaded with reagents necessary for various analyses. One side of the protective cap 2 is pivotally supported so that it can be opened and closed by engaging with the shafts 6 a and 6 b formed on the base substrate 3 and the cover substrate 4. When the sample liquid to be examined is blood, the gap between the flow paths of the microchannel structure on which the capillary force acts is set to 50 μm to 300 μm.

  The outline of the analysis process using this analytical device 1 is that the sample solution is spotted on the analytical device 1 in which a diluent is set in advance, and at least a part of the sample solution is diluted with the diluent, and then measurement is performed. It is what.

FIG. 4 shows the shape of the diluent container 5.
4A is a plan view, FIG. 4B is a cross-sectional view taken along line AA of FIG. 4A, FIG. 4C is a side view, FIG. 4D is a rear view, and FIG. These are front views seen from the opening 7. The opening 7 is sealed with an aluminum seal 9 as a seal member after filling the interior 5a of the diluent container 5 with the diluent 8 as shown in FIG. 6 (a). On the opposite side of the diluent container 5 from the opening 7, a latch portion 10 is formed. The dilution liquid container 5 is formed between the base substrate 3 and the cover substrate 4 and is set in the dilution liquid container housing part 11 so that the liquid holding position shown in FIG. 6A and the liquid discharge shown in FIG. It is housed in a freely movable position.

FIG. 5 shows the shape of the protective cap 2.
5 (a) is a plan view, FIG. 5 (b) is a cross-sectional view taken along line BB of FIG. 5 (a), FIG. 5 (c) is a side view, FIG. 5 (d) is a rear view, and FIG. These are the front views seen from the opening 2a. As shown in FIG. 6 (a) in the closed state shown in FIG. 1 (a), a locking groove 12 with which the latch portion 10 of the diluent container 5 can be engaged is formed inside the protective cap 2. ing.

  FIG. 6A shows the analysis device 1 before use. In this state, the protective cap 2 is closed, and the latch portion 10 of the diluent container 5 is engaged with the locking groove 12 of the protective cap 2 so as to prevent the diluent container 5 from moving in the arrow J direction. Locked in position. In this state, it is supplied to the user.

  When the protective cap 2 is opened as shown in FIG. 1B against the engagement with the latch portion 10 in FIG. 6A when the sample liquid is spotted, the locking groove of the protective cap 2 As shown in FIG. 6 (b), the bottom portion 2b formed with 12 is elastically deformed, and the engagement between the locking groove 12 of the protective cap 2 and the latch portion 10 of the diluent container 5 is released.

  In this state, the sample solution is spotted on the exposed inlet 13 of the analytical device 1 and the protective cap 2 is closed. At this time, by closing the protective cap 2, the wall surface 14 that has formed the locking groove 12 comes into contact with the surface 5 b of the latch portion 10 of the diluent container 5 on the side of the protective cap 2, and the diluent container 5 is pushed in the direction of arrow J (direction approaching the liquid discharge position). An opening rib 11a as a protruding portion is formed in the diluent container housing portion 11 from the base substrate 3 side. When the diluent container 5 is pushed in by the protective cap 2, the diluent container 5 is inclined obliquely. The aluminum seal 9 stretched on the sealing surface of the opening 7 collides with the opening rib 11a and is broken as shown in FIG.

As shown in FIGS. 7 and 8, the analysis device 1 is set on the rotor 101 of the analysis apparatus 100 with the cover substrate 4 facing downward, so that the component analysis of the sample solution can be performed.
A groove 102 is formed on the upper surface of the rotor 101. When the analysis device 1 is set on the rotor 101, the groove 102 is formed on the rotation support 15 and the protective cap 2 formed on the cover substrate 4 of the analysis device 1. The rotation support portion 16 engages with and accommodates the groove 102.

  When the analysis device 1 is set on the rotor 101 and the door 103 of the analyzer is closed before the rotor 101 is rotated, the set analysis device 1 is moved by the movable piece 104 provided on the door 103 side. The position on the rotational axis of the rotor 101 is pressed against the rotor 101 by the biasing force of the spring 105, and the analysis device 1 rotates integrally with the rotor 101 that is rotationally driven by the rotational driving means 106. Reference numeral 107 denotes an axial center during rotation of the rotor 101. The protective cap 2 is attached in order to prevent the sample liquid adhering to the vicinity of the inlet 13 from being scattered outside due to centrifugal force during analysis.

  As a material of the parts constituting the analysis device 1, a resin material having a low material cost and excellent mass productivity is desirable. Since the analysis apparatus 100 analyzes the sample liquid by an optical measurement method for measuring light transmitted through the analysis device 1, the material of the base substrate 3 and the cover substrate 4 may be PC, PMMA, AS, MS, or the like. A synthetic resin having high transparency is desirable.

  Further, as the material of the diluent container 5, since it is necessary to enclose the diluent 8 in the diluent container 5 for a long period of time, a crystalline synthetic resin having a low moisture permeability such as PP and PE is desirable. . As a material for the protective cap 2, there is no particular problem as long as it is a material with good moldability, and an inexpensive resin such as PP or PE is desirable.

  The base substrate 3 and the cover substrate 4 are preferably joined by a method that hardly affects the reaction activity of the reagent carried in the storage area. Ultrasonic welding or laser welding is less likely to generate reactive gas or solvent during joining. Etc. are desirable.

  Further, a hydrophilic treatment for increasing the capillary force is applied to the portion where the solution is transferred by the capillary force due to the minute gap between the substrates 3 and 4 by joining the base substrate 3 and the cover substrate 4. Specifically, hydrophilic treatment using a hydrophilic polymer or a surfactant is performed. Here, hydrophilic means that the contact angle with water is less than 90 °, more preferably less than 40 °.

FIG. 9 shows the configuration of the analyzer 100.
The analysis apparatus 100 includes a rotation drive unit 106 for rotating the rotor 101, an optical measurement unit 108 for optically measuring the solution in the analysis device 1, and the rotation speed and direction of the rotor 101 and optical. Control means 109 for controlling the measurement timing and the like of the measurement means, a calculation unit 110 for processing the signal obtained by the optical measurement means 108 and calculating the measurement result, and for displaying the result obtained by the calculation unit 110 Display unit 111.

  The rotation driving means 106 not only rotates the analyzing device 1 around the rotation axis 107 at a predetermined rotation speed around the rotation axis 107 via the rotor 101 but also centers on the rotation axis 107 at a predetermined stop position. The analyzing device 1 can be swung by reciprocating left and right in a predetermined amplitude range and cycle.

  The optical measurement means 108 includes a light source 112 for irradiating light to the measurement unit of the analysis device 1 and a photodetector for detecting the amount of transmitted light that has passed through the analysis device 1 out of the light emitted from the light source 112. 113.

  The analysis device 1 is driven to rotate by the rotor 101, and the sample liquid taken into the inside from the injection port 13 is rotated around the rotation axis 107 located on the inner periphery of the injection port 13. The centrifugal force generated and the capillary force of the capillary channel provided in the analysis device 1 are used to transfer the solution inside the analysis device 1. The channel structure will be described in detail along with the analysis process.

FIG. 10 shows the vicinity of the inlet 13 of the analytical device 1.
FIG. 10A shows an enlarged view of the injection port 13 as seen from the outside of the analytical device 1, and FIG. 10B shows the microchannel structure seen through the cover substrate 4 from the rotor 101 side. It is. The inlet 13 has a shape protruding from the axial center 107 set in the analysis device 1 in the outer peripheral direction, and a minute gap formed between the base substrate 3 and the cover substrate 4 so as to extend in the inner peripheral direction. Since it is connected to the capillary cavity 19 that can hold the required amount by the capillary force via the guide portion 17 on which the capillary force of δ acts, the sample liquid 18 is directly attached to the inlet 13 by opening the protective cap 2. Thus, the sample liquid adhering to the vicinity of the injection port 13 is taken into the analysis device 1 by the capillary force of the guide portion 17.

  The cross-sectional shape perpendicular to the flow direction of the guiding portion 17 (the DD cross section in FIG. 10B) is not a vertical rectangular shape as shown in FIG. 18 on the back side, but as shown in FIG. The rear end is formed with an inclined surface 20 that becomes gradually narrower toward the cover substrate 4. The guide portion 17, the capillary cavity 19, and the connection portion are formed with a bent portion 22 that forms a recess 21 in the base substrate 3 and changes the direction of the passage.

  A separation cavity 23 serving as a receiving cavity in a gap where a capillary force does not act is formed beyond the capillary cavity 19 when viewed from the guide portion 17. A cavity 24 having one end connected to the separation cavity 23 and the other end open to the atmosphere is formed on a side of a part of the capillary cavity 19, the bent portion 22, and the guide portion 17. By the action of the cavity 24, the sample liquid collected from the injection port 13 is preferentially transmitted through the side wall of the guide portion 17 and the capillary cavity 19 where the cavity 24 is not formed, as shown in FIG. 10B. Thus, the air in the capillary cavity 19 is discharged toward the cavity 24, and the sample liquid 18 can be filled without entraining bubbles.

  FIG. 11 shows a state before the analysis device 1 after spotting is set on the rotor 101 and rotated. At this time, as explained in FIG. 6C, the aluminum seal 9 of the diluent container 5 collides with the opening rib 11a and is broken. Reference numerals 25 a, 25 b, 25 c, and 25 d are air holes formed in the base substrate 3.

− Step 1 −
As shown in FIG. 12A, the analysis device 1 holds the sample solution in the capillary cavity 19 and is set on the rotor 101 in a state where the aluminum seal 9 of the diluent container 5 is broken.

− Step 2 −
When the rotor 101 is rotationally driven in the clockwise direction (C2 direction) after the door 103 is closed, the held sample solution is broken at the position of the bent portion 22, and the sample solution in the guide portion 17 is discharged into the protective cap 2. Then, the sample liquid 18 in the capillary cavity 19 flows into the separation cavity 23 as shown in FIGS. 12B and 15A, and is centrifuged into the plasma component 18a and the blood cell component 18b in the separation cavity 23. The The diluent 8 that has flowed out of the diluent container 5 flows into the holding cavity 27 via the discharge channels 26a and 26b. When the diluent 8 that has flowed into the holding cavity 27 exceeds a predetermined amount, the excess diluent 8 flows into the overflow cavity 29 via the overflow channel 28 and further through the rib 30 for backflow prevention to the reference measurement chamber. It flows into 31.

  The diluent container 5 has a bottom portion opposite to the opening 7 sealed with the aluminum seal 9 and is formed with an arcuate surface 32 as shown in FIGS. 4 (a) and 4 (b). At the liquid discharge position of the state diluent container 5 shown in 12 (b), as shown in FIG. 13, the center m of the arc surface 32 is offset by a distance d so as to be closer to the discharge channel 26b side than the rotation axis 107. Therefore, the diluent 8 that has flowed toward the arc surface 32 is changed to a flow (in the direction of arrow n) from the outside toward the opening 7 along the arc surface 32, and the diluent container 5 is changed. Are efficiently discharged from the opening 7 to the diluent container housing 11.

− Step 3 −
Next, when the rotation of the rotor 101 is stopped, the plasma component 18 a is sucked up into the capillary cavity 33 formed on the wall surface of the separation cavity 23, and is passed through the capillary channel 37 communicating with the capillary cavity 33 as shown in FIG. As shown in FIG. 15B, the fixed amount flows through the metering flow path 38 and is held. FIG. 15C shows a perspective view of the capillary cavity 33 and its periphery.

− Step 4 −
When the rotor 101 is rotationally driven in the counterclockwise direction (C1 direction), as shown in FIG. 14B, the plasma component 18a held in the measuring flow path 38 is measured through the backflow preventing rib 39 to the measurement chamber 40. In addition, the diluent 8 in the holding cavity 27 flows into the measurement chamber 40 through the siphon-shaped connection channel 41 and the backflow prevention rib 39. Further, the sample liquid in the separation cavity 23 flows into the overflow cavity 36 via the siphon-shaped connection channel 34 and the rib 35 for backflow prevention. Then, as necessary, the rotor 101 is reciprocally rotated counterclockwise (C1 direction) and clockwise (C2 direction) and is swung to comprise the reagent, the diluent 8 and the plasma component 18a carried in the measurement chamber. Stir the solution to be measured.

− Step 5 −
When the rotor 101 is rotated counterclockwise (C1 direction) or clockwise (C2 direction) and the measurement spot of the reference measurement chamber 31 passes between the light source 112 and the photodetector 113, the calculation unit 110 of the photodetector 113 The reference value is determined by reading the detected value. Further, at the timing when the measurement spot of the measurement chamber 40 passes between the light source 112 and the photodetector 113, the calculation unit 110 reads the detection value of the photodetector 113 and calculates a specific component based on the reference value.

  As described above, since the diluent container 5 can be opened by opening and closing the protective cap 2 when the user collects the sample solution, and the diluent can be transferred into the analysis device 1, the analyzer can be simplified. The cost can be reduced, and the operability for the user can be improved.

  Furthermore, since the diluent container 5 sealed with the aluminum seal 9 as the sealing member is used, and the diluent container 5 is opened by breaking the aluminum seal 9 with the opening rib 11a as the projecting portion, The analysis accuracy can be improved without the dilution liquid evaporating and decreasing.

  6A, the latch portion 10 of the diluent container 5 is engaged with the locking groove 12 of the closed protective cap 2, and the diluent container 5 is engaged. Is held at the liquid holding position so that it does not move in the direction of arrow J, so that the diluent container 5 is configured to be movable in the diluent container housing portion 11 by opening and closing the protective cap 2. During the period until the user opens the protective cap 2 and uses it, the position of the diluent container 5 in the diluent container housing 11 is locked to the liquid holding position, so that the user can transport the container before use. There is no case where the diluent container 5 is accidentally opened and the diluent is spilled.

  FIG. 16 shows a manufacturing process in which the analyzing device 1 is set to the shipping state shown in FIG. First, before closing the protective cap 2, the groove 42 (see FIGS. 2 and 4 (d)) provided in the lower surface of the diluent container 5 and the hole 43 provided in the cover substrate 4 are aligned, At the liquid holding position, the protrusion 42a of the locking jig 44 provided separately from the base substrate 3 or the cover substrate 4 is engaged with the groove 42 of the diluent container 5 through the hole 43 to hold the diluent container 5 with the liquid. Set in a locked state. Then, the protective cap 2 is closed in a state where the pressing jig 46 is inserted from the notch 45 (see FIG. 1) formed on the upper surface of the protective cap 2 and the bottom surface of the protective cap 2 is pressed and elastically deformed. Can be set to the state shown in FIG. 6A by releasing the pressing jig 46.

The shape in the vicinity of the capillary cavity 19 from the inlet 13 will be described in detail.
As shown in FIGS. 10 (b) and 17 (a), the connecting portion between the guiding portion 17 and the capillary cavity 19 is formed with a bent portion 22 and a recessed portion 21 to change the direction of the passage. In “Step 2”, when the rotor 101 is rotationally driven in the clockwise direction (C2 direction), the sample liquid held in the capillary cavity 19 is broken at the position of the bent portion 22, and the fixed amount of sample liquid is separated from the cavity. We were able to send to 23. In other words, the fact that the sample liquid held in the capillary cavity 19 is broken at the position of the bent portion 22 means that the amount of the sample liquid discharged into the protective cap 2 is limited to a very small amount in the guide portion 17. This can be limited, and it is possible to avoid a situation in which the sample liquid held in the capillary cavity 19 is accidentally discharged into the protective cap 2, which is effective in maintaining safety. Here, the distance L1 from the axis 107 (the center of the groove 42 provided on the lower surface of the diluent container 5) to the bent portion 22 and the distance L2 from the axis 107 to the capillary cavity 19 are L1 = L2. .

Furthermore, in order to improve the safety described above, it is desirable that the bent portion 22 is formed at an inner peripheral position (L1 <L2) than the capillary cavity 19 as shown in FIG.
Further, as shown in FIG. 10C, the cross-sectional shape of the guiding portion 17 is formed by the inclined surface 20 that gradually narrows toward the cover substrate 4 as shown in FIG. As shown in the figure, a larger capillary force acts than in the case where the cross-sectional shape of the guide portion 17 is formed to have a constant cross-sectional rectangle up to the innermost end, and the sample liquid can be reliably taken into the capillary cavity 19 and lost. Thus, the amount of the sample solution in the guiding unit 17 can be reduced.

  Further, since the analysis apparatus 100 rotates the analysis device 1 around the axis 107 (the center of the groove 42 provided on the lower surface of the diluent container 5) set inside the analysis device 1, Compared to a conventional analyzer that is driven to rotate about an axis set outside the analyzing device 1, the radius of rotation is small, and a reduction in size can be realized.

  In each of the above embodiments, the case where the groove 42 is provided on the lower surface of the diluent container 5 has been described as an example. However, the groove 42 is provided on the upper surface of the diluent container 5, and the groove 42 corresponds to the groove 42. The base substrate 3 may be provided with a hole 43 so that the protrusion 44 a of the locking jig 44 is engaged with the groove 42.

  In the above embodiment, the locking groove 12 of the protective cap 2 is directly engaged with the latch portion 10 of the diluent container 5 to lock the diluent container 5 in the liquid holding position. It is also possible to indirectly engage the locking groove 12 and the latch portion 10 of the diluent container 5 to lock the diluent container 5 at the liquid holding position.

  In each of the above embodiments, the analysis device 1 is rotated around the rotation axis 107 to transfer the components centrifuged from the sample solution and the diluent 8 released from the diluent container 5 to the measurement chamber 40. In this example, the solution component separated from the sample solution or the reaction product of the solution component separated from the sample solution and the reagent is accessed for analysis, but the solution component is separated from the sample solution. If this is not necessary, the centrifugal separation step is not necessary. In this case, the analytical device 1 is rotated around the rotation axis 107 to determine the quantity of the sample liquid deposited. All of the sample liquid and the diluent 8 released from the diluent container 5 are transferred to the measurement chamber 40 for dilution, and the solution component diluted with the diluent or the reaction product of the solution component diluted with the diluent and the reagent Access to analyze. Further, the analysis device 1 is rotated around the rotation axis 107 and the solid component separated from the sample solution and the diluted solution released from the diluent container 5 are transferred to the measurement chamber for dilution and separated from the sample solution. It is also possible to access and analyze the reaction product of the solid component separated from the sample solution or the solid component and the reagent.

  In the above embodiment, the analysis device body in which the microchannel structure having a fine uneven shape on the surface is formed in the two layers of the base substrate 3 and the cover substrate 4, but the substrate of three or more layers Can also be configured. Specifically, a three-layer structure that forms a microchannel structure by centering a substrate having a notch formed in accordance with the microchannel structure and bonding another substrate on the upper and lower surfaces thereof to close the notch. The structure can be given as an example.

(Embodiment 2)
21 to 23 show the vicinity of the inlet 13 of the analytical device 1A of the second embodiment. Other parts are the same as those of the first embodiment.

  In the case of the structure of the analysis device 1 according to the first embodiment, the posture of the analysis device 1 is vertical as shown in FIG. 19 and the injection port 13 is brought into contact with the blood reservoir 121 of the fingertip 120 of the examinee. Thus, blood as a sample is sucked up to the capillary cavity 19 by the capillary force of the guiding portion 17 and the capillary cavity 19. However, it has been found that when the sample solution is sucked up with the analytical device 1 in the vertical position, the suction force is reduced due to the influence of gravity applied to the sample solution, so that the suction time is significantly reduced. It was. In addition, while it is necessary to keep the injection port 13 in contact with the fingertip 120 during suction, it is not easy to operate the analysis device 1 in the same posture on the fingertip 120 of the examinee for several tens of seconds or more. I have also understood that. FIG. 20A shows a cross-sectional view of the vicinity of the injection port 13 and the guiding portion 17 represented by the EE cross section of FIG. 10, and FIG. 20B shows a sample solution (blood) 18 in the injection port 13. It shows the state that is attached.

  Therefore, in the second embodiment, as shown in FIG. 21 (a), a part of the inner surface of the base substrate 3 forming the portion of the injection port 13 of the base substrate 3 and the cover substrate 4 is formed as shown in FIG. As shown in FIG. 22A, the liquid reservoir 122 is formed at the starting end of the guiding portion 17 by thinly forming the guiding portion 17 by a distance longer than that in the case of FIG. 10.

  In the case of the structure of the analyzing device 1A in which the liquid reservoir portion 122 is formed, the inlet of the analyzing device 1 is set to be vertical or inclined as shown in FIG. By bringing 13 into contact with the blood reservoir 121 of the fingertip 120 of the examinee, the gap of the liquid reservoir 122 is instantaneously filled by the surface tension of the blood 18. The volume of the liquid reservoir 122 is desirably set to at least a fixed amount of blood necessary for carrying out the analysis, but may be set to about half of the necessary amount of blood.

  Even if the analysis device 1 is separated from the fingertip after the inlet 13 is brought into contact with the blood reservoir 121, the blood accumulated in the liquid reservoir 122 as shown in FIG. 17 and the capillary force of the capillary cavity 19 sucks blood as a sample into the capillary cavity 19. In addition, after the analytical device 1 is removed from the fingertip, the blood suction time can be shortened by maintaining the posture of the analytical device 1 in such a manner that gravity does not affect the suction of the sample liquid in the horizontal direction. It becomes. In addition, even when the time during which the analysis device 1 is kept in contact with the examinee's fingertip 120 is shorter than before, the quantitative blood can be sampled and an accurate analysis can be realized.

(Embodiment 3)
24 to 26 show the vicinity of the inlet 13 of the analyzing device 1B of the third embodiment. Other parts are the same as those of the first embodiment.

  In the analysis device 1A of the second embodiment, a part of the inner surface of the base substrate 3 is thinly formed to form the liquid reservoir 122. However, in the analysis device 1B of the third embodiment, FIG. As shown in FIG. 24B and FIG. 25A, the base substrate 3 and the length of the cover substrate 4 forming the inlet 13 portion of the base substrate 3 and the cover substrate 4 are set as shown in FIG. The liquid reservoir 122 is formed at the start end of the guide portion 17 by making the tip 4a of the cover substrate 4 arc-shaped.

  In the case of the structure of the analytical device 1B in which the liquid reservoir 122 is formed, the posture of the analytical device 1 is inclined as shown in FIG. 26, and the injection port 13 is placed in the blood reservoir 121 of the fingertip 120 of the examinee. By bringing them into contact with each other, as shown in FIG. 25 (b), a fixed amount of blood necessary for performing the analysis adheres to the liquid reservoir 122 due to the surface tension of the blood 18.

  With this configuration, even after the inlet 13 is brought into contact with the blood reservoir 121 and the analytical device 1 is separated from the fingertip, the blood adhering to the reservoir 122 is caused by the capillary force of the guiding portion 17 and the capillary cavity 19. The blood as a sample is sucked up to the capillary cavity 19. In addition, after the analytical device 1 is removed from the fingertip, the blood suction time can be shortened by maintaining the posture of the analytical device 1 in such a manner that gravity does not affect the suction of the sample liquid in the horizontal direction. It becomes. In addition, even when the time during which the analysis device 1 is kept in contact with the examinee's fingertip 120 is shorter than before, the quantitative blood can be sampled and an accurate analysis can be realized.

(Embodiment 4)
27 to 29 show the vicinity of the inlet 13 of the analyzing device 1C of the fourth embodiment. Other parts are the same as those of the first embodiment.

In the analysis device 1B of the third embodiment, the liquid reservoir 122 is formed at the starting end of the guide portion 17 by forming the tip 4a of the cover substrate 4 in an arc shape.
Is formed in a circular arc shape perpendicular to the base substrate 3 to form the liquid reservoir 122, whereas in the analyzing device 1C of the fourth embodiment, FIGS. 27 (a) and 28 (a). As shown in FIG. 2, the planar shape of the tip 4a of the cover substrate 4 is an arc shape, and the cross-sectional shape of the tip 4a is formed on the inclined surface 4b with the base substrate 3 side receding toward the guide portion 17 to A liquid reservoir 122 is formed therebetween. A groove 123 reaching the liquid reservoir 122 from the tip of the injection port 13 is formed on the inner surface of the base substrate 3 of the injection port 13.

  In the case of the structure of the analytical device 1C in which the liquid reservoir 122 is formed, the posture of the analytical device 1 is inclined as shown in FIG. 29, and the injection port 13 is placed in the blood reservoir 121 of the fingertip 120 of the examinee. As a result of the contact, as shown in FIG. 28 (b), a fixed amount of blood necessary for performing the analysis adheres to the liquid reservoir 122 due to the surface tension of the blood 18. Further, since the air at the back end portion of the liquid reservoir 122 is smoothly discharged through the groove 123, the fixed amount of blood can be quickly attached to the liquid reservoir 122.

  With this configuration, even after the inlet 13 is brought into contact with the blood reservoir 121 and the analytical device 1 is separated from the fingertip, the blood adhering to the reservoir 122 is caused by the capillary force of the guiding portion 17 and the capillary cavity 19. The blood as a sample is sucked up to the capillary cavity 19. In addition, after the analytical device 1 is removed from the fingertip, the blood suction time can be shortened by maintaining the posture of the analytical device 1 in such a manner that gravity does not affect the suction of the sample liquid in the horizontal direction. It becomes. In addition, by forming the groove 123, blood can be guided to the guide portion 17 through the groove 123 even in blood that is not formed in a spherical shape by the fingertip (a state where the fingertip is wet and spread). In the present embodiment, only one groove 123 is formed, but a plurality of grooves 123 may be formed, and the cross-sectional shape of the groove 123 may be formed in an arc shape, a triangular shape, or a quadrangular shape.

(Embodiment 5)
In each of the above-described embodiments, the sample liquid sucked up through the guiding portion 17 and the capillary cavity 19 is transferred to the subsequent measurement chamber 40 and used for reading to access the inspection object in the measurement chamber 40 as a measurement spot. Although the case of the analysis device has been described as an example, the sample liquid is directly sucked into the measurement chamber having capillary force from the injection port 13 and used for reading to access the inspection object entered in the measurement chamber. Even in the case of a device, even if it takes a short time to bring the inlet 13 into contact with the blood pool by providing the liquid reservoir 122 described in the second to fourth embodiments, the liquid reservoir Since the blood adhering to the portion 122 is sucked up by the capillary force of the measurement chamber, It can achieve precise analysis.

  In addition, a filter material is provided in a part or all of the liquid reservoir 122 of each of the above embodiments, and the components sucked up from the liquid reservoir 122 into the guide portion 17 having capillary force and the measurement chamber having capillary force are filtered. It is also possible to sort by material. Specifically, when the sample liquid is blood, the filter material prevents or reduces the passage of blood cell components, thereby selecting components that contact the reagent in the measurement chamber so that the reagent and plasma components are accurate. It is possible to reduce the variation of the reaction in response to the reaction and to improve the analysis accuracy.

  The present invention is useful as a transfer control means for an analytical device used for component analysis of a liquid collected from a living organism.

FIG. 3 is an external perspective view of the analytical device according to the first embodiment of the present invention with the protective cap closed and opened. Exploded perspective view of the analysis device of the same embodiment A perspective view of the analytical device with the protective cap closed as seen from the back Explanatory drawing of the diluent container of the embodiment Explanatory drawing of the protective cap of the embodiment Sectional drawing of the state in which the protective cap is closed before using the analytical device of the same embodiment, when spotting the sample liquid, and after spotting Perspective view just before setting the analysis device to the analyzer Sectional view of the analysis device set in the analyzer Configuration diagram of the analyzer of the same embodiment The enlarged perspective view of the principal part of the device for analysis of the embodiment Sectional view before setting the analysis device to the analyzer and starting rotation Sectional view after setting the analytical device in the analyzer and rotating and then centrifuging Sectional drawing which shows the position of the diluent container at the timing when the diluent is released from the rotation axis of the device for analysis and the diluent container Sectional view when the solid component of the sample solution after centrifugation is quantitatively collected and diluted Enlarged view and perspective view of main parts Cross-sectional view of the process to set to the shipping state The top view of the same part of another embodiment with the plane between the inlet port of the same embodiment and a capillary cavity Sectional drawing of the comparative example of the embodiment Explanatory drawing of the analysis device use state of Embodiment 1 of this invention EE sectional view in FIG. The expansion perspective view of the principal part of the analysis device of Embodiment 2 of this invention and the expansion perspective view of a base substrate EE sectional view in FIG. 21B before and after spotting Explanatory drawing of the usage state of the analytical device of the same embodiment The expansion perspective view of the principal part of the analysis device of Embodiment 3 of this invention and the expansion perspective view of a base substrate EE sectional view in FIG. 24B before and after spotting Explanatory drawing of the usage state of the analytical device of the same embodiment The expansion perspective view of the principal part of the analysis device of Embodiment 4 of this invention and the expansion perspective view of a base substrate EE sectional view in FIG. 27 (b) before and after spotting Explanatory drawing of the usage state of the analytical device of the same embodiment Partially cutaway perspective view of analysis device of Patent Document 1 Plan view of analysis device of Patent Document 2

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Analytical device 2 Protective cap 2a Opening 2b Bottom part 3 Base substrate 4 Cover substrate 5 Diluent container 5a Inside 5b Surface of latch part 10 6a, 6b Shaft 7 Opening 8 Diluent 9 Aluminum seal (seal member)
DESCRIPTION OF SYMBOLS 10 Latch part 11 Dilution liquid container accommodating part 12 Groove for latching 13 Inlet 11a Opening rib (protrusion part)
DESCRIPTION OF SYMBOLS 15,16 Rotation support part 17 Guidance part 18 Sample liquid 18a Plasma component 18b Blood cell component 19 Capillary cavity 20 Inclined surface 21 Recessed part 22 Bending part 23 Separation cavity (receiving cavity)
24 Cavity 25a, 25b, 25c, 25d Air hole 26a, 26b Discharge flow path 27 Holding cavity 28 Overflow flow path 29 Overflow cavity 30 Rib 31 Reference measurement chamber 32 Arc surface 33 Capillary cavity 33 Connection flow path 35 Rib 36 Overflow Flow cavity 37 Capillary flow path 38 Metering flow path 39 Backflow prevention rib 40 Measurement chamber 41 Connection flow path 42 Groove 43 Hole 44 Locking jig 44a Protrusion 45 Notch 46 Pressing jig 100 Analyzing apparatus 101 Rotor 102 Groove 103 Door DESCRIPTION OF SYMBOLS 104 Movable piece 105 Spring 106 Rotation drive means 107 Rotation axis center 108 Optical measurement means 109 Control means 110 Calculation part 111 Display part 112 Light source 113 Photo detector 120 Examiner's fingertip 121 Blood pool 122 Liquid reservoir part 123 Groove

Claims (10)

It has a microchannel structure that rotates around an axial center set inside and transports the sample liquid toward the internal measurement spot by centrifugal force accompanying the rotation drive, and the reaction liquid in the measurement spot An analytical device used to access and read
An inlet that projects from the axis toward the outer circumference and collects the sample liquid from the tip;
A guide section on which capillary force is formed so as to extend in an inner circumferential direction from the inlet;
A capillary cavity capable of holding a necessary amount of sample liquid collected from the inlet through the guide portion by capillary force; and
A receiving cavity for receiving a sample liquid transferred from the capillary cavity;
An analytical device in which a concave portion is formed in a connection portion between the guide portion and the capillary cavity to change a direction of a passage.   The analytical device according to claim 1, further comprising a protective cap that holds a sample liquid scattered from the guide portion outside the injection port. The analytical device according to claim 1, wherein a cavity opened to the atmosphere is formed on a side of the base portion, the bent portion, and the capillary cavity of the guide portion. The analytical device according to claim 3, wherein a cross-sectional shape perpendicular to the flow direction of the guide portion is formed by an inclined surface that gradually becomes narrower toward the back end. 2. The analytical device according to claim 1, wherein the bent portion is formed on the same circumference as the capillary cavity with respect to the axial center or at an inner circumferential position with respect to the capillary cavity. An analysis apparatus in which the analysis device according to claim 1 that has collected a sample liquid is set,
Rotational drive means for rotating the analytical device about an axis;
Analyzing means for accessing and analyzing reactants in the analytical device based on the solution transferred by the rotary drive means;
An analyzer configured to transfer a sample liquid in the capillary cavity to the receiving cavity by rotation of the rotation driving means. An analysis method using the analysis device according to claim 1,
The analytical device is rotated around an axial center set inside the analytical device, and the sample liquid spotted on the inlet of the analytical device is broken at the bent portion and held in the capillary cavity. Transferring only the prepared sample liquid to the receiving cavity;
Mixing a reagent with at least a portion of the transferred sample liquid;
And a step of accessing a reaction product of the measurement spot at a timing at which the measurement spot is present at a reading position. It has a microchannel structure that rotates around an axial center set inside and transports the sample liquid toward the internal measurement spot by centrifugal force accompanying the rotation drive, and the reaction liquid in the measurement spot An analytical device used to access and read
An inlet that projects from the axis toward the outer circumference and collects the sample liquid from the tip;
A guide section on which capillary force is formed so as to extend in an inner circumferential direction from the inlet;
A capillary cavity capable of holding a necessary amount of sample liquid collected from the inlet through the guide portion by capillary force; and
A receiving cavity for receiving a sample liquid transferred from the capillary cavity;
Connecting the receiving cavity to the measurement spot;
An analysis device in which a liquid reservoir for temporarily holding the sample solution before being sucked into the guide is formed at the start end of the guide. A concave portion is formed in the connecting portion between the guide portion and the capillary cavity to form a bent portion that changes the direction of the passage.
The analytical device according to claim 8. Claim 8 or claim 9 Symbol mounting analyzing device provided with a filter to the liquid reservoir.

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