Specimen processing system

Abstract

Provided is a specimen processing instrument and a specimen processing system configured for easy size reduction.　In the present invention, a cartridge instrument (200) is for processing a specimen to make the condition of a substance of interest in the specimen suitable for analysis. The cartridge instrument comprises: a reservoir member (32) having a disk-shaped top part; and a holding member (31) that holds the reservoir member (32). The reservoir member (32) has a plurality of reservoir parts (32b) for holding a specimen and a reagent for processing the specimen. The plurality of reservoir parts (32b) are provided along the circumference of a disk part (32a), so as to extend downward under the disk part (32a). The reservoir member (32) is rotatably held by the holding member (31), where the center of the disk part (32a) serves as an axis of rotation, and also includes a cover member (33) that covers the holding member (31) and the reservoir member (32) from above. The cover member (33) has an opening on the top surface thereof, and a pipette tip can be inserted through the opening.

Description

Technical Field

[0001] The present invention relates to a specimen processing apparatus and a specimen processing system.

Background Art

[0002] Conventionally, as an apparatus for processing a specimen, the apparatus of Patent Document 1 has been proposed. In this apparatus, a plurality of chambers fixed to the peripheral portion and storing a specimen, a reagent, etc. are provided, and a central portion that can be selectively communicated with the plurality of chambers and is surrounded by the plurality of chambers is rotated, so that a desired reagent is supplied to the specimen side through the central portion, and the specimen is processed.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, in the above conventional apparatus, it is necessary to provide a mechanism for supplying a desired reagent to the specimen side through the central portion by rotating the central portion surrounded by the plurality of chambers, and the structure of the apparatus becomes complicated, and there is room for improvement from the viewpoint of making the apparatus compact.

[0005] The present invention is for solving the above problems in the prior art, and an object thereof is to provide a specimen processing apparatus and a specimen processing system that can be easily made compact.

Means for Solving the Problems

[0006] In order to solve the above-described problems and achieve the object, the specimen processing according to claim 1 SystemA specimen processing apparatus that performs processing to make a test target in a specimen suitable for testing A specimen processing system including a system, a rotation driving device, a discharge and suction device, and a temperature control device, wherein the specimen processing device It has a disk-shaped storage member at the upper part and a holding member that holds the storage member. The storage member has a plurality of storage means for storing the specimen and reagents for processing the specimen respectively. The plurality of storage means are provided along the circumference of the disk so as to extend downward of the disk. The storage member is rotatably held by the holding member about the center of the disk. The plurality of storage means include a first storage means for mixing and storing the specimen and the reagent, and a second storage means for storing the reagent, the second storage means being adjacent to the first storage means. The first storage means extends downward to a position lower than the second storage means and the rotation driving device rotates the storage member about an axis, The discharge suction the suction device discharges or suctions the specimen or the reagent, the discharge and suction device includes discharge and suction means, the discharge and suction means moves up and down from above the storage member at a predetermined position, the storage member is rotatable such that the plurality of storage means selectively face the predetermined position, the temperature control device has a recess in an upper portion capable of accommodating at least one of the storage means, and is movable in the vertical direction at a predetermined position below the storage member of the specimen processing device 。

[0007] The specimen processing according to claim 2 System is the specimen processing according to claim 1 System In this case, it includes a cover member that covers the holding member and the storage member from above, and the cover member has an opening on the upper surface through which a pipette tip can be inserted.

[0009] The specimen processing according to claim 3 System is the specimen processing according to claim 1 or 2 System In this case, the test target is a nucleic acid and the processing is nucleic acid extraction.

[0011] Claim 4 The specimen processing system according to claim is the specimen processing system according to claim Any one of 1 to 3 In the specimen processing system according to claim, the discharge and suction means is a pipette tip.

[0013] Claim 5 The specimen processing system according to claim is the specimen processing system according to any one of claims 1 to 4 In the specimen processing system according to any one of claims, it includes a separation device, and the separation device is movable in the vertical direction at a predetermined position below the storage member of the specimen processing device.

Advantages of the Invention

[0014] The specimen processing according to claim 1 System According to this, it has a storage member with a disk-shaped upper part and a holding member for holding the storage member. Since the storage member has a plurality of storage means and the storage member is rotatably held, for example, the structure of the specimen processing apparatus can be simplified, so that it is possible to provide a specimen processing apparatus that can be easily made compact. Further, the plurality of storage means include a first storage means for mixing and storing a specimen and a reagent, and a second storage means for storing a reagent, the second storage means being adjacent to the first storage means. Since the first storage means extends downward more than the second storage means, for example, by providing a device (for example, a temperature control device or a separation device, etc.) for processing the specimen below the storage member, it becomes possible to efficiently process the specimen using the device. Further, by including a specimen processing device, a rotation driving device, and a discharge and suction device, for example, the specimen processing device can be easily made compact, so that it is possible to provide a specimen processing system that can be easily made compact. Also, for example, the discharge and suction device includes discharge and suction means, the discharge and suction means moves up and down from above the storage member at a predetermined position, and the storage member is rotatable such that the plurality of storage means selectively face the predetermined position. Thus, for example, using the discharge and suction means, operations such as mixing the specimen and the reagent stored in the plurality of storage means can be performed, so that it is possible to automatically bring the inspection target in the specimen into a state suitable for inspection. Also, the temperature control device has a recess in an upper portion capable of accommodating at least one of the storage means, and is movable in the vertical direction at a predetermined position below the storage member of the specimen processing device. Thus, for example, at an appropriate timing, it is possible to perform an operation of adjusting the temperature on the storage means side using the temperature control device at a position where it does not interfere with the discharge and suction means.

[0015] The specimen processing according to claim 2 System According to this, it includes a cover member that covers the holding member and the storage member from above. Since the cover member has an opening through which a pipette tip can be inserted on the upper surface, for example, it becomes possible to prevent foreign matter from mixing into the storage means of the storage member. Also, for example, it becomes possible to access the specimen or reagent in the storage means using a pipette tip without detaching the cover member.

[0017] Claim 3 The specimen processing described in System According to this, since the inspection target is nucleic acid and the processing is nucleic acid extraction, for example, it is possible to provide a specimen processing apparatus that can be easily made compact and that performs nucleic acid extraction.

[0019] Claim 4According to the specimen processing system described in [reference], since the discharge and suction means is a pipette tip, for example, operations such as mixing the specimen and reagents stored in a plurality of storage means can be performed using the pipette tip. Therefore, it is possible to automatically make the inspection target in the specimen in a state suitable for inspection.

[0021] Claim 5 According to the specimen processing system described in [reference], since the separation device is movable in the vertical direction at a predetermined position below the storage member of the specimen processing device, for example, at an appropriate timing, the separation device can be used at a position where it does not interfere with the discharge and suction means, and the separation operation can be performed.

Brief Description of the Drawings

[0022]

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Mode for Carrying Out the Invention

[0023] Hereinafter, with reference to the accompanying drawings, embodiments of the specimen inspection system according to the present invention will be described in detail. First, [I] the basic concept of the embodiment will be described, then [II] the specific content of the embodiment will be described, and finally, [III] modifications to the embodiment will be described. However, the present invention is not limited by the embodiments.

[0024] 〔I〕Embodiment's Basic Concept First, the basic concept of the embodiment will be described. Generally speaking, the specimen inspection system according to the embodiment generates a sample containing the inspection target by performing a process of extracting the inspection target on a specimen containing the inspection target, and performs inspections such as biochemical inspection, hematological inspection, nucleic acid inspection, or immunoassay on the generated sample containing the inspection target.

[0025] Here, "biochemical test" means a test for measuring components in a sample such as blood using colorimetry, turbidity measurement, enzyme method, enzyme activity method, etc. The items measured in this "biochemical test" are arbitrary, and examples include AST, ALT, and γ-GT in liver function tests, LDL cholesterol, HDL cholesterol, and triglycerides in lipid tests, and blood glucose and HbA1c in diabetes tests. Also, "hematological test" means a test for performing quantitative and qualitative tests on mainly blood cell components and plasma components in blood. The items measured in this "hematological test" are arbitrary, and examples include red blood cell count, hemoglobin amount, white blood cell count, hematocrit, platelet count, etc. Also, "nucleic acid test" is a nucleic acid amplification test, which is a test for detecting or quantifying specific deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a sample. Representative nucleic acid tests include polymerase chain reaction method (PCR method), TMA method, NASBA method, LAMP method, etc., which are nucleic acid amplification methods, as well as DNA probe method, Southern hybridization method, Northern hybridization method, etc. Also, "immunological test" means a test for measuring or detecting components in a sample such as urine and blood using antigen-antibody reaction. Examples of the types of "immunological tests" applicable to the present invention include nephelometry, immunoturbidimetry, agglutination method, enzyme immunoassay (EIA) (e.g., chemiluminescent EIA (CLEIA), ELISA), fluorescence immunoassay, chemiluminescent immunoassay, electrochemiluminescent immunoassay, chemically amplified luminescence proximity homogeneous assay, etc. Also, the items measured in the "immunological test" are arbitrary, and examples include pathogenic bacteria or viruses of infectious diseases, or antibodies against them, hormones, cancer markers, autoantibodies, etc.

[0026] In addition, examples of the types of "specimen containing the test object" include serum, plasma, whole blood, blood cell components, urine, feces, sputum, cerebrospinal fluid, oral mucosa, pharyngeal mucosa, intestinal mucosa, vaginal mucosa, and biopsy samples (e.g., fine needle aspiration (FNA) samples of the thyroid gland, intestinal samples, liver samples). Further, examples of the types of "sample containing the test object" include processed samples obtained by treating the above-described specimen containing the test object with an acid, an alkali, a protein denaturant, a surfactant, an oxidizing agent, a reducing agent, an enzyme, dilution, filtration, extraction, heating, concentration, etc., or a combination thereof.

[0027] (Configuration) First, the configuration of the specimen inspection system will be described. FIG. 1 is a perspective view of a cartridge device according to an embodiment of the present invention, FIG. 2 is a schematic plan view of the specimen inspection system, FIG. 3 is a schematic front view of the specimen inspection system, FIG. 4 is a schematic side view of the specimen inspection system, and FIG. 5 is an exploded perspective view of the cartridge device. In FIG. 2, a part of the temperature control device 91 and the processing device 92 is actually in a hidden and invisible state, but is illustrated by a broken line for convenience of explanation. The X - Y - Z axes in each figure are assumed to be mutually orthogonal axes, the Z - axis direction is the vertical direction, the +Z direction is referred to as the upper side, the -Z direction is referred to as the lower side, and the Y - axis direction and the X - axis direction are the horizontal directions. The following description will be made based on this.

[0028] The specimen inspection system 100 in FIG. 2 is a system for performing biochemical inspection, hematological inspection, nucleic acid inspection, or immunoassay. Hereinafter, an example will be illustratively described in the case where the specimen inspection system 100 generates a sample containing the test object by performing a process of extracting the test object on a specimen containing the nucleic acid as the test object, and performs a nucleic acid amplification test based on the real - time PCR method on the generated sample containing the test object. Note that the "real - time PCR method" is a type of PCR method for amplifying DNA or RNA, and is a method of monitoring and analyzing in real - time while amplifying DNA or RNA.

[0029] The specimen inspection system 100 shown in FIG. 2 is a specimen inspection system that performs processing to make the inspection target in the specimen suitable for inspection, and is also a system that performs a nucleic acid inspection (specifically, a nucleic acid amplification inspection) on a sample containing the inspection target generated by performing the above processing.

[0030] Generally speaking, the specimen inspection system 100 includes a pipette tip 1 shown in FIG. 3, a discharge and suction device (not shown), a cartridge device 200, a rotation drive device (not shown), a detection device (for example, a light irradiation device and a fluorescence detection device, not shown), a temperature control device 91, a processing device 92, and a control unit (not shown).

[0031] Also, although the electrical connection method of each part in the specimen inspection system 100 is arbitrary, communication or power supply can be directly or indirectly performed between the discharge and suction device, the rotation drive device, the detection device, the temperature control device 91, or the processing device 92 and the control unit.

[0032] (Configuration - Pipette Tip) The pipette tip 1 shown in FIG. 3 or FIG. 4 is a discharge and suction means for discharging and sucking a liquid or gas (for example, air) such as a sample or a reagent containing nucleic acid as the inspection target. The type and configuration of this pipette tip 1 are arbitrary. For example, it is formed of a resin material or a glass material, and is configured to discharge and suck a liquid or gas such as a sample or a reagent through a pipette tip side opening 11 provided at the tip. Note that this pipette tip 1 may be interpreted as a part of the discharge and suction device. A pipette tip having an opening for discharge and suction can be replaced for each sample or reagent used, and can be preferably used to prevent contamination. However, the opening for discharge and suction is not limited to the pipette tip. For example, the tip of a nozzle may be used. When using the opening at the tip of the nozzle, a device for cleaning the tip of the nozzle is required for each use.

[0033] A "reagent" is a chemical used to prepare a sample for testing within a flow channel device described below. For example, it is a chemical used to subject nucleic acids in a sample to a nucleic acid amplification reaction. Examples of "reagents" for use in nucleic acid amplification reactions include, for example, chaotropic agents for extracting nucleic acids from cells, bacteria, etc. in a sample, nucleic acid extraction solutions such as surfactants, magnetic particle solutions containing magnetic silica beads for recovering the extracted nucleic acids, washing solutions for removing impurities, and enzymes such as DNA polymerase for performing nucleic acid amplification, nucleic acid amplification solutions containing dNTPs, etc.

[0034] (Configuration - Dispensing and Suction Device) The dispensing and suction device (not shown) is a device that discharges and suctions liquids or gases such as samples or reagents containing nucleic acids via a pipette tip 1, or supports and moves the pipette tip 1. The type and configuration of this dispensing and suction device are arbitrary. For example, it is configured using a known dispensing device (as an example, a dispensing device equipped with a nozzle and a pump not shown), and is also configured with a support mechanism that supports by holding a part of the upper side (+Z direction) of the pipette tip, and is further configured with an actuator or the like for moving the pipette tip 1 in the vertical direction (Z-axis direction), front-rear direction (Y-axis direction), or left-right direction (X-axis direction) while the pipette tip 1 is being supported.

[0035] (Configuration - Cartridge Device) The cartridge device 200 in FIGS. 1 to 5 is a sample processing device for performing processing to make a sample suitable for testing, and is also a testing device for performing nucleic acid testing on a sample containing nucleic acids. Details of this cartridge device 200 will be described later.

[0036] (Configuration - Rotation Drive Device) The rotation drive device (not shown) is a device that rotates the storage member 32 in Fig. 5 about a rotation axis 300 passing through the center of the storage member 32. The "rotation axis" 300 is the axis with respect to which the storage member 32 rotates, is an axis along the vertical direction (Z-axis direction), and is an axis shown for convenience of explanation. The specific type and configuration of the rotation drive device are arbitrary. For example, it includes a rotation motor provided below (-Z direction) the storage member 32 and a long transmission member for transmitting the rotational force of the rotation motor to the storage member 32. Then, by connecting the tip of this transmission member to the rotation member attachment portion 301 of the storage member 32, the rotational force of the rotation motor can be transmitted to the storage member 32 via the transmission member, and the storage member 32 rotates based on the transmitted rotational force. The rotation drive device may be arranged, for example, laterally instead of below the storage member 32, and the rotation axis 300 may be rotated via a belt or the like. Also, as the power source of the rotation drive device, various motors and air cylinders are generally used, and it may be configured as a mechanism for transmitting power by means of pulleys, cranks, gears, etc. via a belt.

[0037] (Configuration - Detection Device) The detection device (not shown) is a detection means for detecting a target component contained in a sample accommodated in the accommodation portion 21 of the flow path device 2 in Fig. 5. This detection device is configured using, for example, a known detection device (as an example, a light irradiation device and a fluorescence detection device), etc., and is provided in the vicinity of the flow path device 2.

[0038] (Configuration - Temperature Control Device) The temperature control device 91 in FIGS. 2 to 4 is a temperature control means for directly or indirectly heating or cooling the flow path device 2, and heats or cools at least a part of the temperature control device 91, preferably through the upper surface (the surface on the upper side (+Z direction)), and is fixedly provided in the vicinity of the flow path device 2. The specific type and configuration of this temperature control device 91 are arbitrary. For example, any heating means or cooling means used in a normal real-time PCR reaction, such as a Peltier element, an oil bath, air, etc., can be used. In the illustrated example, it is configured using a Peltier element capable of directly heating and cooling the flow path device 2.

[0039] (Device for configuration - processing) In nucleic acid testing, the processing device 92 in FIGS. 2 to 4 is a device used for performing the process of extracting nucleic acid from a sample. Also, as shown in FIGS. 3 and 4, it is preferably a device provided on the lower side (-Z direction) of the cartridge device 200, and is a device equipped with an actuator (not shown) and movable in the vertical direction (Z-axis direction) by the actuator. The specific type and configuration of this processing device 92 are arbitrary. For example, it includes a temperature control unit 921 and a separation unit 922. Note that the temperature control unit 921 and the separation unit 922 may be integrally formed as the processing device 92 as in the illustrated example, or may be formed as separate processing devices.

[0040] In the illustrated example, the temperature control unit 921 is a recess into which one storage unit 32b is inserted from the upper side (+Z direction) of the processing device 92. It is also a part where known heating means (such as heating wires) for heating the inserted storage unit 32b are provided around it. Further, it is a part provided at a position facing each storage unit 32b when the storage member 32 rotates. Note that the temperature control unit 921 and the heating means in the processing device 92 correspond to the temperature control device. In the illustrated example, the temperature control unit 921 is constituted by a recess, but the shape is not limited to a recess as long as the temperature of the storage unit 32b can be maintained at an appropriate temperature. For example, it may be a through-hole, or may be a shape in which flat heating means are brought into contact with the storage unit 32b from one direction or a plurality of directions. Also, it may be an oil bath or a water bath. The temperature control unit 921 does not necessarily have to directly surround the storage unit 32b. For example, it may be a member that blows warm air onto the storage unit 32b from the vicinity.

[0041] The separation unit 922 is a member for applying a magnetic field to the storage unit 32b. In the illustrated example, it is arranged in the processing device 92 provided below the storage unit 32b (-Z direction). However, when the processing device 92 moves upward (+Z direction) (that is, when the separation unit 922 moves toward the storage unit 32b side), it is configured such that one storage unit 32b is inserted. The separation unit 922 is a part having known magnetic field generation means (such as neodymium magnets, electromagnets, etc.), and moves up and down to apply a magnetic field from one direction or a plurality of directions on the side of the storage unit 32b. Further, the separation unit 922 is a part provided adjacent to a position facing each storage unit 32b when the storage member 32 rotates. In the example shown in FIG. 2, it is a part provided at a position corresponding to the second end portion 331b of the long hole 331 of the cover member 33 described later in the XY plane. However, the installation position does not necessarily have to be the position in the illustrated example. For example, it may be arranged closer to the rotation axis side than the position facing the storage unit 32b. Note that the separation unit 922 and the magnetic field generation means in the processing device 92 correspond to the separation device. In the illustrated example, a configuration in which the processing device 92 moves up and down is shown, but a configuration in which the separation unit 922 moves up and down may also be used, or a configuration in which the separation unit 922 moves in the horizontal direction may also be used.

[0042] (Configuration - Control Unit) The control unit (not shown) is a unit that controls each part of the specimen inspection system 100, and includes an operation unit, a communication unit, an output unit, a power supply unit, a control unit, and a storage unit (all not shown).

[0043] (Configuration - Control Unit - Operation Unit, Communication Unit, Output Unit, Power Supply Unit) The communication unit is a communication means for communicating between the ejection and suction device, the rotation drive device, the detection device, the temperature control device 91, or the processing device 92 and the control unit. The output unit is an output means for outputting various information based on the control of the control unit, and is configured using, for example, known display means or voice output means. The power supply unit is a power supply means for supplying the power supplied from a commercial power supply or a battery (e.g., a battery, etc.) to each part of the control unit and also to the ejection and suction device, the rotation drive device, the detection device, the temperature control device 91, or the processing device 92.

[0044] (Configuration - Control Unit - Control Unit) The control unit is a control means for controlling each part of the control unit. Specifically, this control unit is a computer configured to include a CPU, various programs interpreted and executed on the CPU (including basic control programs such as an OS and application programs that are started on the OS and realize specific functions), and an internal memory such as a RAM for storing programs and various data.

[0045] (Configuration - Control Unit - Storage Unit) The storage unit is a storage means for storing programs and various data necessary for the operation of the control unit, and is configured using a rewritable known recording medium, and for example, a non - volatile recording medium such as a flash memory can be used.

[0046] (Configuration - Details of the Configuration of the Cartridge Device) Next, the details of the configuration of the cartridge device 200 in FIGS. 1 to 5 will be described. However, this cartridge device 200 can be manufactured in any shape, method, and material, unless otherwise specified.

[0047] As shown in FIG. 5, the cartridge device 200 includes a flow path device 2, a holding member 31, a storage member 32, and a cover member 33.

[0048] (Configuration - Details of the Configuration of the Cartridge Device - Flow Path Device) FIG. 6 is a perspective view of an example of the flow path device as viewed from above, FIG. 7 is a perspective view of an example of the flow path device as viewed from below, and FIG. 8 is a plan view of an example of the flow path device. In FIGS. 6 and 7, the accommodation portion 21 provided inside the flow path device 2 is shown by a dashed line, and in FIG. 8, the flow paths communicating between the accommodation portion 21 and the flow path device side opening 22 are shown by dashed lines. Note that the shape of the flow paths and the accommodation portion 21 inside the flow path device can be appropriately changed according to the purpose, and any known shape can be used.

[0049] The flow path device 2 in FIGS. 6 to 8 is an accommodation device for accommodating a liquid sample containing nucleic acid in nucleic acid testing. The specific type and configuration of this flow path device 2 are arbitrary. For example, it is in a flat plate shape as a whole, and when used for real-time PCR, it is formed of a light-transmitting material (such as a transparent resin) in order to detect fluorescence, and it is also elastically deformable. The flow path device 2 further includes a first portion 2a, a second portion 2b, a protruding portion 2c, an accommodation portion 21, and a flow path device side opening 22.

[0050] The first part 2a is a part of the flow path device 2 and is thicker than the second part 2b in the illustrated example. The second part 2b is a part of the flow path device 2, is thinner than the first part 2a in the illustrated example, and protrudes from the first part 2a. The protrusions 2c are provided at two positions at the end on the side of the first part 2a in the flow path device 2 and protrude in the direction (X-axis direction) orthogonal to the direction (Y-axis direction) in which the flow path device 2 extends. In the present invention, it is not essential to provide the protrusions 2c, but as will be described later, it is preferable to provide the protrusions 2c from the viewpoint of more securely fixing the flow path device to the holding member.

[0051] The accommodating part 21 is a part that accommodates a sample of a liquid containing nucleic acid in nucleic acid testing, is provided in the second part 2b of the flow path device 2, is provided on the tip side (+Y direction) in the second part 2b, and is provided in six positions in the illustrated example. The flow path device side opening 22 functions at least as an inlet for allowing a sample of a liquid containing nucleic acid to flow into the accommodating part 21, communicates with the accommodating part 21 via a flow path, and is provided on the upper surface (+Z direction surface) of the flow path device 2. And this flow path (for example, the flow path illustrated in FIG. 8) is configured such that the sample supplied to the flow path device side opening 22 is supplied to the accommodating part 21 via the flow path. Since any configuration including known configurations can be applied to the specific configuration of the flow path, detailed description thereof is omitted.

[0052] (Configuration - Details of the Configuration of the Cartridge Device - Holding Member) FIG. 9 is a perspective view of the holding member as viewed from above, FIG. 10 is a perspective view of the holding member as viewed from below, FIG. 11 is a cross-sectional view taken along line A-A of FIG. 9, and FIG. 12 is a cross-sectional view of the holding member with the flow path device held. In FIG. 12, a cross-sectional view taken along line A-A of FIG. 9 with the flow path device 2 held is shown.

[0053] The holding member 31 in FIGS. 9 to 12 is a member that holds the flow path device 2 and the storage member 32 in FIG. 5. The specific type and configuration of this holding member 31 are arbitrary. For example, it is generally in the shape of a flat plate. Also, when the pipette tip 1 in FIG. 3 moves above the holding member 31 (in the +Z direction), it forms the bottom surface facing the pipette tip side opening 11 of the pipette tip 1, and it is formed of a resin material or the like. Further, the holding member 31 includes an upper surface 31a in FIG. 9, a bottom surface 31b in FIG. 10, a side surface 31c in FIG. 9, a recess 311, a first opening 312, an inclined surface 313 in FIG. 10, and a second opening 314.

[0054] The upper surface 31a in FIG. 9 is the upper surface (+Z direction) of the holding member 31, the bottom surface 31b in FIG. 10 is the lower surface (-Z direction) of the holding member 31, and the side surface 31c is the surface that forms the periphery of the holding member 31.

[0055] The recess 311 in FIG. 9 is a recessed portion for positioning the flow path device 2 with respect to the holding member 31, and it is provided at a position adjacent to the first opening 312 in FIGS. 9 and 11 on the upper surface 31a of the holding member 31. It is also a portion that accommodates the first portion 2a (that is, the end portion of the flow path device 2) of the flow path device 2 in FIG. 6, and it is a portion having a shape corresponding to the first portion 2a.

[0056] The first openings 312 in FIGS. 9 and 11 are openings through which the flow path device 2 is disposed, and are also openings that penetrate from the upper surface 31a side to the bottom surface 31b side. The inclined surfaces 313 in FIGS. 10 and 11 are surfaces that incline downward (-Z direction) as they are away from the concave portion 311. The inclination angle of this inclined surface 313 is arbitrary. For example, as shown in FIG. 12, a part of the flow path device 2 held by the holding member 31 abuts against the tip 313a of the inclined surface 313 and elastically deforms, so that at least a part of the flow path device 2 is inclined with respect to the bottom surface 31b of the holding member 31. It may be set by performing experiments, simulations, etc. in advance. Note that the inclined surface 313 is a configuration for facilitating the installation of the flow path device 2. However, if conditions such as the thickness of the holding member 31 being sufficiently thin and the flexibility of the flow path device 2 being sufficiently high are met and a desired inclination can be given to the flow path device 2, it is not necessarily required to form it as an inclined surface, and it may be a vertically straight surface in the vertical direction.

[0057] The second opening 314 in FIGS. 9 and 10 is a portion for holding the storage member 32. As a whole, it has a slightly larger diameter than the disk portion 32a of the storage member 32 in FIG. 6, but the inner stepped portion 314a has a smaller diameter than the disk portion 32a. Thus, since the stepped portion 314a is provided, when the storage member 32 is passed through the second opening 314 from the upper side (+Z direction) of the storage member 32, the peripheral edge of the disk portion 32a of the storage member 32 is caught by the stepped portion 314a, and the storage member 32 is held by the holding member 31.

[0058] (Configuration - Details of the Configuration of the Cartridge Device - Storage Member) FIG. 13 is a perspective view of the storage member as viewed from above, and FIG. 14 is a perspective view of the storage member as viewed from below.

[0059] The storage member 32 in FIGS. 13 and 14 is a specimen processing device that makes the nucleic acid in the specimen suitable for testing in nucleic acid testing. Specifically, it is a device for performing nucleic acid extraction. The specific type and configuration of the storage member 32 are arbitrary. For example, it is rotatably held by the holding member 31 with the center of the disk portion 32a of the storage member 32 as the axis. Also, it is rotatable so that a plurality of storage portions 32b selectively face a position corresponding to the second end portion 331b of the long hole 331 of the cover member 33 described later. Further, it is formed of a resin material or the like and includes a disk portion 32a and a storage portion 32b.

[0060] The disk portion 32a is a part of the upper side (+Z direction) of the storage member 32. It is also a disk-shaped part that is a disk. It includes a rotating member attachment portion 301 and an opening portion 302. The rotating member attachment portion 301 is a portion to which a transmission member of a rotation driving device (not shown) is connected and is provided at the center of the disk portion 32a. The opening portion 302 is an opening provided on the same circumference of the disk portion 32a with respect to the center of the disk portion 32a and is an opening that communicates with the inside of the storage portion 32b provided on the lower side (-Z axis direction) of the disk portion 32a.

[0061] The storage portion 32b is a plurality of storage means for storing the specimen and the reagents for processing the specimen respectively. It is provided along the circumference of the disk portion 32a so as to extend downward (-Z direction) of the disk portion 32a, and a plurality of storage portions 32b are provided. The number, shape, and size of each of these storage portions 32b are arbitrary and can be appropriately changed according to the desired specimen processing conditions. In the illustrated example, eight storage portions 32b with different lengths and shapes are provided. Also, what is stored in each of these storage portions 32b is arbitrary. For example, the specimen and the reagent are mixed and stored in one storage portion, and the reagent (for example, a liquid containing a chaotropic agent or a liquid containing magnetic beads) is stored in another storage portion, and the reagent (for example, a washing liquid) is stored in still another storage portion.

[0062] (Configuration - Details of the Configuration of the Cartridge Device - Cover Member) FIG. 15 is a perspective view of the cover member as viewed from above, FIG. 16 is a perspective view of the cover member as viewed from below, and FIG. 17 is a cross-sectional view taken along line B-B of FIG. 16.

[0063] The cover member 33 in FIGS. 15 to 17 is a member that covers the holding member 31 and the storage member 32 in FIG. 5 from above (+Z direction). Specifically, it is a member that covers at least a part of the holding member 31 from the upper surface 31a side in FIG. 9. The specific type and configuration of this cover member 33 are arbitrary, but for example, it is formed of a resin material or the like. Further, the cover member 33 includes an upper portion 33a in FIG. 15, side portions 33b, a hollow portion 33c in FIGS. 16 and 17, a long hole 331 in FIG. 15, an adjustment portion 332, and a protrusion 333 in FIG. 17. Note that the cover member 33 may be provided with an engaging portion 335 for fixing to the holding member 31.

[0064] The upper portion 33a in FIG. 15 is a portion that forms the upper (+Z direction) surface (upper surface) of the cover member 33. The side portion 33b is a portion that forms the peripheral side surface of the cover member 33. The hollow portion 33c in FIGS. 16 and 17 is a space provided on the back side (-Z direction) of the cover member 33 and is a portion surrounded by the upper portion 33a and the side portions 33b.

[0065] The long hole 331 in FIG. 15 is a long hole that penetrates in the vertical direction (Z-axis direction) from a position facing the storage member 32 in FIG. 5 to a position facing the flow path device 2. It is also an opening through which the pipette tip 1 can be inserted, and includes a first end portion 331a and a second end portion 331b in FIG. 15. The first end portion 331a in FIG. 15 is a portion facing the flow path device side opening 22 in FIG. 5 and is a circular portion having a diameter through which the pipette tip 1 can be inserted from the tip to a desired length. The second end portion 331b in FIG. 15 is a portion facing each opening 302 of the storage member 32 in FIG. 5 and is a circular portion having a diameter through which the pipette tip 1 can be inserted from the tip to a desired length.

[0066] The adjustment part 332 in Fig. 15 is an adjustment means for adjusting the verticality of the pipette tip 1 with respect to the flow path device side opening 22 in Fig. 5 by contact with the pipette tip 1, and is the part where the pipette tip 1 abuts. The "verticality of the pipette tip 1" is a concept corresponding to the degree to which the long axis of the pipette tip 1 extends along the vertical direction (Z-axis direction). For example, from the viewpoint of accurately positioning the pipette tip side opening 11 of the pipette tip 1 with respect to the flow path device side opening 22, the closer the long axis of the pipette tip 1 extends along the vertical direction (that is, the closer the inner angle formed by the longitudinal direction of the pipette tip 1 and the vertical direction is to 0 degrees), the more preferable it is. The adjustment part 332 in Fig. 15 protrudes upward (+Z direction) from the upper part 33a, and in the illustrated example, covers a part of the first end 331a of the long hole 331. Also, in the illustrated example, it is provided with an enlarged part that opens toward the second end 331b side (-X direction), and the pipette tip 1 that moves horizontally from the second end 331b side to the first end 331a side (+X direction) is guided into the adjustment part 332 through the enlarged part and can abut against the inside of the adjustment part 332. Note that the adjustment part 332 does not necessarily have to be located at the position of the first end 331a of the long hole 331, and may be located at another position adjacent to or separated from the long hole 331. In this case, after the verticality of the pipette tip 1 is adjusted at a position separated from the first end 331a of the long hole 331, the pipette tip 1 moves to the first end 331a.

[0067] The protrusions 333 in FIGS. 15 to 17 are fixing means for fixing the flow path device 2 in FIG. 12 to the holding member 31. In the examples shown in FIGS. 16 and 17, a part of the protrusion 333 is provided adjacent to the long hole 331 along the longitudinal direction (X-axis direction) of the long hole 331. And the height of the protrusion 333 in the vertical direction (Z-axis direction) is configured such that when the cover member 33 is attached to the holding member 31 in FIG. 12, the protrusion 333 abuts on the first part 2a of the flow path device 2 held by the holding member 31. By configuring in this way, the flow path device 2 abutted on the protrusion 333 will be pressed and fixed to the holding member 31 by the protrusion 333. Note that the position of the protrusion 333 does not necessarily need to be adjacent to the long hole 331 as long as the flow path device 2 can be fixed to the holding member.

[0068] (Assembly method of the cartridge device) Next, an assembly method of the cartridge device 200 in the illustrated example will be described. FIGS. 18 and 19 are perspective views of some components of the cartridge device, and FIG. 20 is a cross-sectional view of the cartridge device. Note that in FIG. 20, a cross-sectional view of the same cross-section as the cross-sectional view in FIG. 12 is illustrated.

[0069] First, the storage member 32 is attached to the holding member 31 in FIG. 5. For example, by passing the storage member 32 from above (+Z direction) through the second opening 314 of the holding member 31 in FIG. 9, as shown in FIG. 18, the storage member 32 is attached to the holding member 31. Here, the peripheral edge of the disk portion 32a of the storage member 32 is caught by the step portion 314a in FIG. 9, so that the storage member 32 is rotatably attached and held to the holding member 31.

[0070] Next, attach the flow path device 2 to the holding member 31 in FIG. 5. For example, by passing the tip of the flow path device 2 (the end on the side where the housing portion 21 is provided) through the concave portion 311 and the first opening 312 in FIG. 9, as shown in FIG. 19, attach the flow path device 2 to the holding member 31. In the illustrated example, the protruding portion 2c of the flow path device 2 in FIG. 6 is disposed in the concave portion 311 of the holding member 31 in FIG. 9 and is hooked, thereby preventing the flow path device 2 from falling off the holding member 31. The flow path device 2 is to be provided at a predetermined interval from the storage member 32. The separation distance between the flow path device 2 and the storage member 32 is preferably made as short as possible to shorten the moving distance of the discharge suction means, to the extent that the strength of the holding member is not impaired.

[0071] Next, attach the cover member 33 to the holding member 31 in FIG. 5. Specifically, attach the cover member 33 to the holding member 31 from above (+Z direction) of the holding member 31. In the illustrated example, by engaging the engaging portion 335 in FIG. 16 with the outer shape of the holding member 31, the cover member 33 is fixed to the holding member 31. In this case, the protrusion 333 provided on the cover member 33 in FIGS. 15 to 17 abuts on the first portion 2a of the flow path device 2 in FIG. 20 and presses and fixes the first portion 2a to the bottom of the concave portion 311 in the holding member 31 from above (+Z direction). As shown in FIG. 12, a part of the flow path device 2 abuts on the tip portion 313a of the inclined surface 313 and is elastically deformed, and at least a part of the flow path device 2 is inclined with respect to the bottom surface 31b of the holding member 31. Also, in this case, the second portion 2b of the flow path device 2 extends with an inclination downward (-Z direction) from the bottom surface 31b side of the holding member 31. Thus, the assembly of the cartridge device 200 in FIG. 1 is completed.

[0072] (Mounting method of cartridge device) Next, the method of attaching the cartridge device 200 will be described. It is assumed that each component of the specimen inspection system 100 other than the cartridge device 200 is provided at a predetermined position in a housing (not shown) of the specimen inspection system 100, and the description will focus particularly on the relative positions of the temperature control device 91 and the processing device 92 and the cartridge device 200. FIGS. 21 and 22 are cross-sectional views of the holding member, the flow path device, and the temperature control device when attaching the cartridge device. In FIGS. 21 and 22, cross-sectional views of the same cross-section as the cross-sectional view of FIG. 12 are shown.

[0073] First, the cartridge device 200 in FIG. 1 is attached by placing and fixing a part of the cartridge device 200 on an attachment member (not shown) (for example, any member that supports a part of the cartridge device 200). In this case, the height of the bottom surface 31b of the holding member 31 in FIG. 22 of the cartridge device 200 is substantially the same as the height of the upper surface of the temperature control device 91 (the surface in the +Z direction, which is a horizontal surface). Therefore, as shown in FIG. 21, before the cartridge device 200 is fixed to the attachment member (not shown), a part of the second portion 2b of the flow path device 2 that was inclined downward (-Z direction) is pressed against the temperature control device 91 and elastically deformed as shown in FIG. 22, so that a part of the second portion 2b becomes horizontal and adheres closely to the upper surface of the temperature control device 91, and the housing portion 21 of the flow path device 2 in FIG. 5 adheres closely to the temperature control device 91. In this case, as described above, since the first portion 2a of the flow path device 2 is fixed to the holding member 31 in FIG. 22 by the protrusion 333 of the cover member 33 in FIG. 16, the housing portion 21 of the flow path device 2 will surely adhere closely to the temperature control device 91.

[0074] Next, a transmission member of a rotation driving device (not shown) is connected to the rotation member attachment portion 301 in FIG. 5. And when the cartridge device 200 is attached to the attachment member (not shown) in this way, as shown in FIGS. 2 and 3, the processing device 92 will be provided below (-Z direction) the storage member 32. Thus, the attachment of the cartridge device 200 is completed.

[0075] (Control of Specimen Inspection System) Next, the control of the specimen inspection system 100 will be described. Although the control of the specimen inspection system 100 is optional, for example, the control unit (not shown) of the control unit of the specimen inspection system 100 executes the program of the recording unit to perform the specimen processing and specimen measurement described below. In order to do so, the ejection suction device, the rotation drive device, the detection device, the temperature control device 91, and the processing device 92 are controlled at appropriate timings. Here, after individually explaining the control of each device, the nucleic acid extraction process and the nucleic acid inspection process will be explained. FIG. 23 is a side view of the specimen inspection system, and FIG. 24 is a schematic front view of the specimen inspection system. In FIG. 23, for convenience of explanation, only one of the plurality of storage units 32b is shown, and the illustration of the other storage units is omitted.

[0076] (Control of Specimen Inspection System - Control of Ejection Suction Device) First, when controlling a discharge and suction device (not shown), the control unit of the control unit controls the pump or actuator of the discharge and suction device by communicating with the discharge and suction device to control the discharge or suction of the pipette tip 1 in FIG. 3, or to move the pipette tip 1 in the vertical direction (Z-axis direction), front-rear direction (Y-axis direction), or left-right direction (X-axis direction). In particular, regarding the movement in the left-right direction (X-axis direction), since the pipette tip 1 is basically supported along the vertical direction (Z-axis direction) at a position facing the long hole 331 in FIG. 2, the pipette tip side opening 11 of the pipette tip 1 will move in a state facing the long hole 331 in FIG. 2 of the cover member 33 in FIG. 23. In the illustrated example, by moving the pipette tip 1 in the vertical direction (Z-axis direction) at the first end 331a of the long hole 331, the pipette tip side opening 11 can be brought closer to (FIG. 24) or moved away from (FIG. 23) the flow path device side opening 22 in FIG. 2. Also, by moving the pipette tip 1 in the vertical direction (Z-axis direction) at the second end 331b of the long hole 331, the pipette tip side opening 11 can be inserted into and removed from the storage portion 32b through the opening 302 of the storage member 32 in FIG. 5. Note that the vertical movement of the pipette tip 1 does not necessarily have to be at the end of the long hole 331. For example, in the example of FIG. 15, there is a substantially circular widened portion 331c near the center in the longitudinal direction of the long hole 331, and the pipette tip 1 can also be moved in the vertical direction at this widened portion 331c.

[0077] In the illustrated example, the position on the XY plane in the specimen inspection system 100 where the second end 331b is provided corresponds to a predetermined position regarding the pipette tip 1 or the storage portion 32b.

[0078] (Control of the Specimen Inspection System - Control of the Rotation Drive Device) Also, when controlling a rotation driving device (not shown), the control unit of the control unit communicates with the rotation driving device to rotate the rotation motor of the rotation driving device clockwise or counterclockwise by an arbitrary angle, and transmits a rotational force to the storage member 32 in FIG. 5 via the transmission member of the rotation driving device, so that it is possible to rotate the rotation shaft 300 clockwise or counterclockwise by an arbitrary angle around the rotation axis.

[0079] (Control of the Specimen Inspection System - Control of the Detection Device) Also, when controlling a detection device (not shown), the control unit of the control unit communicates with the detection device to detect the target component contained in the sample accommodated in the accommodation unit 21 of the flow path device 2 in FIG. 5.

[0080] (Control of the Specimen Inspection System - Control of the Temperature Control Device) Also, when controlling the temperature control device 91 in FIGS. 2 and 3, the control unit of the control unit can communicate with the temperature control device 91 to perform heating or cooling.

[0081] (Control of the Specimen Inspection System - Control of the Processing Device) Also, when controlling the processing device 92 in FIGS. 2, 3, and 23, the control unit of the control unit communicates with the processing device 92 to control the actuator of the processing device 92, enabling the processing device 92 to move in the vertical direction (Z-axis direction). Further, the control unit of the control unit can heat by using the heating means around the temperature control unit 921 in FIG. 2 by communicating with the processing device 92, and can apply a magnetic field through the magnetic field generating means (such as neodymium magnets, electromagnets, etc.) around the separation unit 922. In particular, as described above, since the temperature control unit 921 and the separation unit 922 in FIG. 2 are provided at positions facing each storage member 32b when the storage member 32 rotates, when the processing device 92 is moved upward (+Z direction) with a predetermined storage member 32b rotated to a position facing the temperature control unit 921, the storage member 32b is inserted into the temperature control unit 921, and the storage member 32b can be heated. Similarly, when the processing device 92 is moved upward (+Z direction) with the storage member 32b rotated to a position facing the separation unit 922, as shown in FIG. 23, the storage member 32b is inserted into the separation unit 922, and a magnetic field can be applied to the storage member 32b. In this case, in the illustrated example, since the other storage member adjacent to the storage member 32b is shorter than the storage member 32b, it is possible to prevent the other storage member from interfering with the processing device 92, so that the predetermined storage member 32b is surely inserted into the temperature control unit 921 or the separation unit 922.

[0082] Note that the position on the XY plane in the specimen inspection system 100 where the temperature control unit 921 and the separation unit 922 of the processing device 92 are provided corresponds to a predetermined position with respect to the processing device 92.

[0083] (Specimen processing) Next, the specimen processing performed using the specimen inspection system 100 will be described. In this specification, as an example of specimen processing, nucleic acid extraction processing will be described. Nucleic acid extraction processing is a process of separating nucleic acids to be inspected contained in a specimen from cells or binding proteins, or removing substances that cause reaction inhibition or the like in subsequent nucleic acid detection from a sample solution containing nucleic acids, and is a process of bringing the nucleic acids into a state suitable for nucleic acid detection according to a known nucleic acid extraction protocol.

[0084] For example, as described above, when assembling the cartridge device 200, a specimen containing nucleic acids is stored in one of the storage parts 32b in FIGS. 13 and 14, and a denaturing reagent containing a chaotropic agent or a surfactant, a reagent containing magnetic beads, a nucleic acid amplification reagent containing DNA polymerase, dNTP, etc., and a washing solution are stored in the other plurality of storage parts 32b, respectively, and the cartridge device 200 can be assembled.

[0085] The nucleic acid extraction process is carried out, for example, according to the following procedure. A reagent stored in one of the storage parts 32b shown in FIGS. 13 and 14 is aspirated with a pipette tip 1 inserted through an opening 302 into the storage part 32b. The pipette tip 1 holding the aspirated reagent moves upward (+Z direction) from the upper end of the opening of the storage part 32b, and then is inserted by moving downward (-Z direction) through the opening into another storage part 32b for storing the sample, and the reagent is discharged at that position. The discharged reagent and the sample are mixed to obtain a desired reaction of the sample. The sample mixed with the reagent may be aspirated and discharged on the spot with the pipette tip 1 for further mixing. At this time, the pipette tip 1 holding the denaturing reagent moves only in the vertical direction, for example, at the position of the second end 331b of the long hole 331 in FIG. 2, and as the storage member 32 rotates about the rotation axis 300, the opening 302 of the storage part 32b that requires liquid aspiration / discharge moves to a position facing the pipette tip side opening 11. When using a liquid sample, the sample can be aspirated and discharged with the pipette tip 1 instead of the reagent, but from the viewpoint of preventing contamination of the sample, it is preferable to aspirate and discharge the reagent. The reagent mentioned here is not particularly limited, but generally, a chaotropic agent that is a protein denaturant or a denaturing reagent containing a surfactant such as SDS is used. Similarly, another reagent can be injected into and mixed with the sample after mixing with the reagent.

[0086] The sample may be heated as needed. In this case, for example, the temperature control part 921 shown in FIG. 4 can be moved upward (+Z direction) from below to contact or approach the storage part 32b containing the sample. Here, instead of the temperature control part 921, the storage member 32 may be moved downward (-Z direction), but from the viewpoint of preventing splashing of the sample, it is preferable to move the temperature control part 921.

[0087] Further, a purification step may be provided to remove substances unnecessary for nucleic acid detection, substances that inhibit nucleic acid detection, etc. from the sample. For example, a particle solution in which magnetic particles that capture the target substance are suspended in the sample is added, and after mixing and reacting, the magnetic particles are magnetically collected to remove the liquid containing unnecessary substances, etc. Further, by adding a washing solution to the magnetically collected magnetic particles, suspending them, and repeating the magnetic collection and liquid removal several times, residual unnecessary substances, etc. can be further removed. The magnetic collection can be performed, for example, by moving the separation unit 922 shown in FIG. 4 upward from the lower side (+Z direction) to contact or approach the target storage unit 32b. Instead of the separation unit 922, the storage member 32 may be moved downward (-Z direction), but from the viewpoint of preventing the sample from splashing, etc., it is preferable to move the separation unit 922.

[0088] (Sample measurement) Next, the sample measurement performed in the sample inspection system 100 will be described. In this specification, as an example of sample measurement, nucleic acid detection (nucleic acid inspection process) using a nucleic acid amplification method will be described. In nucleic acid detection using a nucleic acid amplification method, the nucleic acid to be inspected is mixed with a nucleic acid amplification reagent after being made suitable for inspection by the sample treatment as exemplified above. For the nucleic acid amplification reagent, for example, when performing real-time PCR, one containing DNA polymerase, dNTP, etc. is used. Also for the nucleic acid amplification reagent, like other reagents, the one previously stored in one storage unit 32b is aspirated using the pipette tip 1 and discharged into another storage unit 32b in which the sample containing the processed nucleic acid is stored.

[0089] The sample (pre-amplification sample) mixed with the nucleic acid amplification reagent is aspirated using the pipette tip 1. The pipette tip 1 that aspirates and holds the pre-amplification sample moves upward from the opening 302 of the storage unit 32b (+Z direction), and then moves along the longitudinal direction of the long hole 331 toward the first end 331a in FIGS. 15 and 16 (+X direction), generally without changing the height. The height of the pipette tip 1 during movement is preferably set low enough not to interfere with the movement in order to reduce the influence of leakage of the sample held by the pipette tip 1.

[0090] The pre-amplification sample held in the pipette tip 1 is injected into the interior of the flow path device 2 exemplified in FIGS. 6 to 8 as a device for nucleic acid amplification reaction. In the example shown in FIG. 19, the opening 22 of the flow path device 2 is exposed above the holding member 31 in a state where the flow path device 2 is set in the holding member 31. The opening 11 of the pipette tip 1 moves vertically downward (-Z direction) from above the exposed flow path device side opening 22 and contacts the flow path device side opening 22, and discharges the pre-amplification sample toward the flow path device side opening 22.

[0091] A plurality of accommodating portions 21 inside the flow path device 2 may each be provided in advance with different primers, probes, etc. By being mixed with nucleic acids, DNA polymerase, dNTP, etc. contained in the injected pre-amplification sample, it becomes possible to perform a nucleic acid amplification reaction. Note that the accommodating portion 21 may also be provided in advance with DNA polymerase, dNTP, etc., and the nucleic acid amplification reagent may also contain primers, probes, etc.

[0092] The flow path device 2 is installed in a state of being in close contact with the temperature control device 91 as exemplified in FIG. 22. The temperature control device 91 brings about a desired temperature change programmed in advance for the sample stored in the storage portion 21 of the flow path device 2. The temperature change program can be appropriately changed depending on, in particular, the case of real-time PCR, the base sequences of the DNA serving as a template, the primers, the probes, the material of the flow path device, the shape, etc.

[0093] When the flow path device 2 is not used, the pre-amplification sample may be dispensed into a normal PCR tube or the like by the above-described discharge suction means or manually, and a nucleic acid amplification reaction may be performed using a known thermal cycler or the like.

[0094] (Adjustment of verticality) Next, the adjustment of the verticality of the pipette tip 1 will be described. FIGS. 25 to 27 are front views of the specimen inspection system. Due to any factor (for example, an error at the initial attachment of the pipette tip 1 to the aspiration / dispensing device, or an environmental factor such as the influence of the surrounding environment such as vibration), as shown in FIG. 25, the pipette tip 1 may be supported by the aspiration / dispensing device in a state where it is displaced from the vertical direction (Z-axis direction). In this case, when the pipette tip 1 is moved toward the adjustment unit 332 side (+X direction) at an arbitrary timing in each of the above-described processes, the pipette tip 1 contacts the expansion part of the adjustment unit 332 from the horizontal direction and is guided inside the adjustment unit 332. As shown in FIG. 26, by abutting against the inside of the adjustment unit 332, the support of the pipette tip 1 by the aspiration / dispensing device is corrected by the force received from the adjustment unit 332 when abutting, and as shown in FIG. 27, the pipette tip 1 is supported along the vertical direction (Z-axis direction) and the verticality is adjusted. Therefore, it becomes possible to insert the pipette tip side opening 11 into the flow path device side opening 22 of the flow path device 2 and reliably inject the sample.

[0095] (Effects of the Embodiment) As described above, according to the embodiment, by having the reservoir member 32 with a disk-shaped upper part and the holding member 31 that holds the reservoir member 32, and the reservoir member 32 having a plurality of reservoirs 32b and being rotatably held, for example, the structure of the cartridge device 200 can be simplified, and thus it becomes possible to provide the cartridge device 200 that can be easily made compact.

[0096] Further, by providing the cover member 33 that covers the holding member 31 and the reservoir member 32 from above (+Z direction), and the cover member 33 having the long hole 331 through which the pipette tip 1 can be inserted in the upper part 33a, for example, it becomes possible to prevent foreign matter from entering the reservoir 32b of the reservoir member 32. Also, for example, it becomes possible to access the specimen or reagent in the reservoir 32b using the pipette tip 1 without detaching the cover member 33.

[0097] In addition, since the inspection target is nucleic acid and the process is nucleic acid extraction, for example, it is possible to provide a cartridge device 200 that can be easily compacted, and to provide the cartridge device 200 for performing nucleic acid extraction.

[0098] In addition, by providing the cartridge device 200, a rotation driving device (not shown), and a discharge and suction device (not shown), for example, the cartridge device 200 can be easily compacted, so that it is possible to provide a specimen processing system 100 that can be easily compacted. Further, for example, the discharge and suction device includes a pipette tip 1, and the pipette tip 1 moves up and down from above the storage member 32 at a predetermined position (for example, a position corresponding to the second end portion 331b of the long hole 331), and the storage member 32 is rotatable so that a plurality of storage portions 32b face a predetermined position (for example, a position corresponding to the second end portion 331b of the long hole 331) selectively. Thus, for example, using the pipette tip 1, operations such as mixing the specimen and the reagent stored in the plurality of storage portions 32b can be performed, so that it is possible to automatically make the inspection target in the specimen in a state suitable for inspection.

[0099] Further, the processing device 92 has a temperature control portion 921 capable of accommodating at least one of the storage portions 32b at the upper part, and is movable in the vertical direction at a predetermined position on the lower side (-Z direction) of the storage member 32 of the cartridge device 200. Thus, for example, at an appropriate timing, the function as a temperature control device of the processing device 92 is used at a position where it does not interfere with the pipette tip 1, and it is possible to perform an operation of adjusting the temperature on the storage portion 32b side.

[0100] Further, the processing device 92 is movable in the vertical direction at a predetermined position on the lower side (-Z direction) of the storage member 32 of the cartridge device 200. Thus, for example, at an appropriate timing, the function as a separation device of the processing device 92 is used at a position where it does not interfere with the pipette tip 1, and it is possible to perform a separation operation.

[0101] 〔III〕Modifications to the Embodiment The embodiments of the present invention have been described above. However, the specific configurations and means of the present invention can be arbitrarily modified and improved within the scope of the technical idea of each invention described in the claims. Such modification examples will be described below.

[0102] (Regarding the problems to be solved and the effects of the invention) First, the problems to be solved by the invention and the effects of the invention are not limited to the above-described content. According to the present invention, it is also possible to solve problems not described above or achieve effects not described above. Also, it may solve only some of the described problems or achieve only some of the described effects.

[0103] (Regarding shape, numerical value, structure, time series) Regarding the components exemplified in the above embodiments and drawings, with respect to the shape, numerical value, or the structure or time series mutual relationship of a plurality of components, it can be arbitrarily modified and improved within the scope of the technical idea of the present invention.

[0104] (Regarding elastic deformation) In the above embodiment, the case where the flow path device 2 in FIG. 22 elastically deforms and the second portion 2b of the flow path device 2 comes into close contact with the temperature control device 91 has been described. However, it is not limited thereto. For example, instead of the flow path device 2 or together with the flow path device 2, the holding member 31 or the cover member 33 may be elastically deformed so that the second portion 2b of the flow path device 2 comes into close contact with the temperature control device 91.

[0105] (Regarding the cartridge device)

[0106] In the above-described embodiment, the case where nucleic acid extraction and nucleic acid testing are performed using the cartridge device 200 has been described, but the present invention is not limited thereto. For example, the shape of the cartridge device 200 may be arbitrarily changed and configured as a device for performing only one of nucleic acid extraction or nucleic acid testing. Specifically, in the left-right direction (X-axis direction), it may be divided at a position corresponding to between the second opening 314 and the concave portion 311 in the holding member 31 of FIG. 9 and configured as a device for performing only one of sample processing or sample measurement.

[0107] (Regarding the adjustment unit (Part 1)) In the above-described embodiment, as shown in FIG. 15, the case where only one adjustment unit 332 is provided in the cover member 33 as the adjustment means has been described, but the present invention is not limited thereto. For example, an adjustment unit (adjustment means) having the same shape as the adjustment unit 332 may be provided at a part corresponding to the second end portion 331b of the long hole 331 in the upper portion 33a of the cover member 33. The adjustment unit in this case may be configured to include an expanding portion that opens toward the first end portion 331a side (+X direction).

[0108] Further, at an arbitrary position in the upper portion 33a of the cover member 33, a mortar-shaped hole (insertion hole) having a smaller diameter as it goes downward (-Z direction) is provided as an adjustment means, and the tip of the pipette tip 1 is periodically inserted into the hole from above (+Z direction) of the mortar-shaped hole, thereby correcting the support by the discharge suction device of the pipette tip 1 and adjusting the verticality of the pipette tip 1. In this case, a boss (protruding portion) for forming the aforementioned mortar-shaped hole may be provided on the hollow portion 33c side of the cover member 33. Also, in this case, the diameter of the widest part (the uppermost part (+Z direction)) of the hole is set to be larger than the diameter of the flow path device side opening 22. By configuring in this way, the adjustment means includes an insertion hole into which the tip of the pipette tip 1 is inserted from above (+Z direction), and for example, by inserting the tip of the pipette tip 1 into the insertion hole, it becomes possible to reliably adjust the verticality.

[0109] (Regarding the adjustment unit (Part 2)) In the above-described embodiment, the case where the verticality of the pipette tip 1 is adjusted by bringing the pipette tip 1 into contact with the adjustment unit 332 in FIG. 26 and correcting the support of the pipette tip 1 by the discharge and suction device has been described, but the present invention is not limited thereto. For example, after configuring the internal shape of the adjustment unit 332 to have a smaller diameter as it goes downward (-Z direction), when the pipette tip 1 is moved downward (-Z direction) within the adjustment unit 332, the pipette tip 1 may be configured to be guided so as to face the vertical direction (Z-axis direction), thereby adjusting the verticality of the pipette tip 1. Further, the adjustment unit described in the above-mentioned "(Regarding the adjustment unit (Part 1))" may be configured in the same manner. Further, these adjustment units may be provided at any position in the cover member 33.

[0110] (Regarding the adjustment unit (Part 3)) An arbitrary sensor for measuring the verticality of the pipette tip 1 may be provided for the discharge and suction device (not shown) or the pipette tip 1 of the above-described embodiment, and the control unit of the control unit (not shown) may be configured to communicate with the sensor so that the verticality of the pipette tip 1 can be grasped at an arbitrary timing. In this case, when the control unit of the control unit (not shown) detects that the pipette tip 1 is inclined with respect to the vertical direction (Z-axis direction) based on the detection value of the sensor, at least a part of the pipette tip 1 is adjusted to the adjustment unit 332 described in the embodiment, or the adjustment unit provided on the second end portion 331b side of the elongated hole 331 described in "(Regarding the adjustment unit (Part 1))", or a process of inserting the tip of the pipette tip 1 into the mortar-shaped hole described in "(Regarding the adjustment unit (Part 1))" may be performed to adjust the verticality.

[0111] (Regarding the adjustment unit (Part 4)) In the above embodiment, the case where the adjustment means is provided on the cover member 33 has been described. However, the present invention is not limited to this. For example, it may be provided on the holding member 31. Specifically, although it is arbitrary, for example, on a part of the holding member 31 exposed through the long hole 331 in FIG. 2, a mortar-shaped hole or a protruding adjustment part such as the adjustment part 332 described in "(Regarding the adjustment part (Part 1))" may be provided as the adjustment means. Further, an opening penetrating through an arbitrary position of the cover member 33 may be provided, and a protruding adjustment part such as a mortar-shaped hole or the adjustment part 332 may be provided as the adjustment means on the part of the holding member 31 exposed through the opening.

[0112] (Regarding the adjustment part (Part 5)) After arbitrarily changing the configuration of the specimen inspection system 100 of the above embodiment, an adjustment part may be provided. FIG. 28 is a plan view of a modified example of the specimen inspection system, and FIG. 29 is a side view of the modified example of the specimen inspection system. Note that the cartridge device 600 in FIGS. 28 and 29 may be configured to include an arbitrary cover member similar to the cover member 33 of the cartridge device 200 of the embodiment in FIG. 2 or a cover member without the long hole described in "(Regarding the cover member)" of the modified example described later, or it may be configured without a cover member.

[0113] The specimen inspection system 500 in FIGS. 28 and 29 is the same as the specimen inspection system 100 of the embodiment except for the matters to be specifically noted. The specimen inspection system 500 includes a temperature control device 51 and a cartridge device 600. Note that the temperature control device 51 is the same as the temperature control device 91 of the embodiment. The cartridge device 600 includes a flow path device 6 and a holding member 71.

[0114] The flow path device 6 is configured in the same manner as the flow path device 2 of the embodiment. In particular, it is a flat rectangular shape as a whole and includes a housing part 61 and a flow path device side opening 62. Note that the housing part 61 and the flow path device side opening 62 are the same as the components with the same names in the embodiment.

[0115] The holding member 71 is configured in the same manner as the holding member 31 of the embodiment. In particular, as shown in FIG. 29, the holding member 71 holds the flow path device 6 with the temperature control device 51 interposed therebetween. Further, as shown in FIG. 28, the holding member 71 includes a first opening 711 and an adjustment portion 712. The first opening 711 is a through-opening, and as shown in FIG. 28, it exposes a part of the flow path device 6. The adjustment portion 712 is an adjustment means for adjusting the position of the pipette tip 1 with respect to the flow path device side opening 62 by adjusting the verticality of the pipette tip 1 by contact with the pipette tip 1, and is an insertion hole. The insertion hole is configured to have a smaller diameter as it goes downward (-Z direction), and the diameter of the widest part of the hole (the uppermost part (+Z direction)) is set to be larger than the diameter of the flow path device side opening 62. When configured in this way, when the pipette tip 1 moves to the flow path device side opening 62 side (that is, the adjustment portion 712 side) through the long hole of a cover member (not shown), even if the pipette tip 1 is slightly deviated from the vertical direction (Z-axis direction), when the pipette tip 1 is moved downward (-Z direction), the tip of the pipette tip 1 can be guided to the flow path device side opening 62 while being in contact with the adjustment portion 712, so that the verticality of the pipette tip 1 can be adjusted.

[0116] (Regarding the flow path device side opening) In the above embodiment, the flow path device side opening 22 was described as a portion that functions as an inlet for allowing a sample of a liquid containing nucleic acid to flow into the storage portion 21. However, when suction is performed with the pipette tip side opening 11 of the pipette tip 1 inserted into the flow path device side opening 22, the sample stored in the storage portion 21 can be suctioned. Therefore, it is possible to allow the sample to flow into or out of the pipette tip 1 through the flow path device side opening 22.

[0117] (Regarding the cover member) In the above-described embodiment, the elongated hole 331 was provided in the cover member, but it is also possible to adopt a form without providing the elongated hole. For example, holes into which the tip portion of the chip can be inserted in the vertical direction may be provided at two or three positions corresponding to the positions of the first end portion 331a and the second end portion 331b or the wide portion 331c in FIG. 15, and the other portions may have a structure without openings.

[0118] (Regarding the movement of the pipette tip) In the nucleic acid test process described in the above embodiment, when injecting a sample into the flow path device 2, it was described that the pipette tip 1 was moved from the second end portion 331b side to the first end portion 331a side along the elongated hole 331 in FIG. 2. In this case, the pipette tip side opening 11 may be moved while maintaining the height thereof between the height of the holding member 31 and the upper portion 33a of the cover member 33 in the vertical direction (Z-axis direction), or alternatively, the pipette tip side opening 11 may be moved while maintaining the height thereof above the upper portion 33a of the cover member 33 (+Z direction). Further, when moving the pipette tip side opening 11 while maintaining the height thereof above the upper portion 33a of the cover member 33 (+Z direction), the pipette tip 1 may be moved to an arbitrary position facing the upper portion 33a of the cover member 33 without facing the elongated hole 331 in FIG. 2.

[0119] (Regarding the pipette tip) In the above-described embodiment, the case where the discharge and suction means is the pipette tip 1 was described, but it is not limited thereto. For example, any member (such as a nozzle) that plays the same role as the pipette tip 1 may be used as the discharge and suction means.

[0120] (Regarding storage in the storage portion) In the above-described embodiment, it is arbitrary which of the storage parts in FIG. 13 is used to mix and store the reagent and the specimen. For example, the reagent and the specimen are mixed in one storage part which is shown for convenience as only one in FIG. 23, and only the reagent may be stored in another storage part (a storage part arranged adjacent to the aforementioned one storage part) having a length shorter than that of the only one storage part shown. In this case, the aforementioned one storage part corresponds to the "first storage means" extending downward more than the other storage parts, and the other storage part corresponds to the "second storage means". Note that the storage example described here is merely an example and does not limit the invention. For example, only the reagent may be stored in the aforementioned one storage part, and the reagent and the specimen may be mixed in the other storage part. When configured in this way, the plurality of storage parts 32b include one storage part for mixing and storing the specimen and the reagent, and another storage part for storing the reagent, the other storage part being adjacent to the one storage part. Since the one storage part extends downward more than the other storage parts, for example, by providing a processing device 92 for processing the specimen on the lower side (-Z direction) of the storage member 32, it becomes possible to efficiently process the specimen using the processing device 92.

[0121] (Regarding combinations) The technologies of the above-described embodiment and the modified examples may be arbitrarily combined. For example, as adjustment means, in addition to the adjustment part 332 described in the embodiment, the bowl-shaped hole described in the modified example "(Regarding the adjustment part (Part 1))" may be added, or the adjustment means provided in the holding member described in the modified example "(Regarding the adjustment part (Part 4))" may be added.

[0122] (Supplementary note) The specimen processing apparatus described in Supplementary Note 1 is a specimen processing apparatus that performs processing to make the inspection target in the specimen in a state suitable for inspection, and has a disk-shaped storage member at the upper part and a holding member that holds the storage member. The storage member has a plurality of storage means for storing the specimen and reagents for processing the specimen respectively, and the plurality of storage means are provided along the circumference of the disk so as to extend downward of the disk. The storage member is rotatably held by the holding member about the center of the disk.

[0123] The specimen processing apparatus of Supplementary Note 2 is the specimen processing apparatus described in Supplementary Note 1, and includes a cover member that covers the holding member and the storage member from above, and the cover member has an opening on the upper surface through which a pipette tip can be inserted.

[0124] The specimen processing apparatus of Supplementary Note 3, in the specimen processing apparatus described in Supplementary Note 1 or 2, the plurality of storage means include a first storage means for mixing and storing the specimen and the reagent, and a second storage means for storing the reagent, and the second storage means is adjacent to the first storage means, and the first storage means extends downward to a lower level than the second storage means.

[0125] The specimen processing apparatus of Supplementary Note 4 is the specimen processing apparatus described in any one of Supplementary Notes 1 to 3, in which the inspection target is a nucleic acid and the processing is nucleic acid extraction.

[0126] The specimen processing system of Supplementary Note 5 is a specimen processing system including the specimen processing apparatus described in any one of Supplementary Notes 1 to 4, a rotation drive device that rotates the storage member about the center, and a discharge / suction device that discharges or sucks a specimen or a reagent. The discharge / suction device includes discharge / suction means, and the discharge / suction means moves up and down from above the storage member at a predetermined position, and the storage member is rotatable such that the plurality of storage means selectively face the predetermined position.

[0127] The specimen processing system of Supplementary Note 6 is the specimen processing system described in Supplementary Note 6, in which the discharge / suction means is a pipette tip.

[0128] The specimen processing system of Supplementary Note 7 is the specimen processing system described in Supplementary Note 5 or 6, and includes a temperature control device. The temperature control device has a recess at the upper part capable of accommodating at least one of the storage means, and is movable in the vertical direction at a predetermined position below the storage member of the specimen processing device.

[0129] The specimen processing system of Supplementary Note 8 is the specimen processing system described in any one of Supplementary Notes 5 to 7, and includes a separation device. The separation device is movable in the vertical direction at a predetermined position below the storage member of the specimen processing device.

[0130] (Effect of Supplementary Note) According to the specimen processing device described in Supplementary Note 1, since it has a storage member with a disk-shaped upper part and a holding member for holding the storage member, and the storage member has a plurality of storage means and is rotatably held, for example, the structure of the specimen processing device can be simplified, so it is possible to provide a specimen processing device that can be easily made compact.

[0131] According to the specimen processing device described in Supplementary Note 2, since it includes a cover member that covers the holding member and the storage member from above, and the cover member has an opening through which a pipette tip can be inserted on the upper surface, for example, it is possible to prevent foreign substances from mixing into the storage means of the storage member. Also, for example, it is possible to access the specimen or reagent in the storage means using a pipette tip without detaching the cover member.

[0132] According to the specimen processing device described in Supplementary Note 3, the plurality of storage means include a first storage means for mixing and storing a specimen and a reagent, and a second storage means for storing a reagent, and the second storage means is adjacent to the first storage means. Since the first storage means extends below the second storage means, for example, by providing a device (such as a temperature control device or a separation device, etc.) for processing the specimen below the storage member, it is possible to efficiently process the specimen using the device.

[0133] According to the specimen processing apparatus described in Supplementary Note 4, since the inspection target is nucleic acid and the process is nucleic acid extraction, for example, it is possible to provide a specimen processing apparatus that can be easily made compact, and that can perform nucleic acid extraction.

[0134] According to the specimen processing system described in Supplementary Note 5, by including a specimen processing apparatus, a rotation drive apparatus, and a discharge / suction apparatus, for example, it is possible to easily make the specimen processing apparatus compact, and thus it is possible to provide a specimen processing system that can be easily made compact. Further, for example, the discharge / suction apparatus includes discharge / suction means, the discharge / suction means moves up and down from above a storage member at a predetermined position, and the storage member is rotatable such that a plurality of storage means face it selectively with respect to the predetermined position. Thus, for example, by using the discharge / suction means, operations such as mixing the specimen and reagents stored in the plurality of storage means can be performed, and it becomes possible to automatically bring the inspection target in the specimen into a state suitable for inspection.

[0135] According to the specimen processing system described in Supplementary Note 6, since the discharge / suction means is a pipette tip, for example, by using the pipette tip, operations such as mixing the specimen and reagents stored in the plurality of storage means can be performed, and it becomes possible to automatically bring the inspection target in the specimen into a state suitable for inspection.

[0136] According to the specimen processing system described in Supplementary Note 7, the temperature control device has a recess in the upper part capable of accommodating at least one of the storage means, and is movable in the vertical direction at a predetermined position below the storage member of the specimen processing apparatus. Thus, for example, at an appropriate timing, it is possible to perform an operation of adjusting the temperature on the storage means side by using the temperature control device at a position where it does not interfere with the discharge / suction means.

[0137] According to the specimen processing system described in Supplementary Note 8, since the separation device is movable in the vertical direction at a predetermined position below the storage member of the specimen processing apparatus, for example, at an appropriate timing, it is possible to perform a separation operation by using the separation device at a position where it does not interfere with the discharge / suction means.

Explanation of Signs

[0138] 1 Pipette tip 2 Flow path device 2a First part 2b Second part 2c Protrusion 6 Flow path device 11 Pipette tip side opening 21 Accommodation part 22 Flow path device side opening 31 Holding member 31a Upper surface 31b Bottom surface 31c Side surface 32 Storage member 32a Disc part 33 Cover member 33a Upper part 33b Side part 33c Hollow part 51 Temperature control device 61 Accommodation part 62 Flow path device side opening 71 Holding member 91 Temperature control device 92 Processing device 100 Specimen inspection system 200 Cartridge device 300 Rotating shaft 311 Recess 312 First opening 313 Inclined surface 313a Tip part 314 Second opening 314a Step part 301 Rotating member mounting part 302 Opening 32b Storage part 331 Long hole 331a First end 331b Second end 331c Wide part 332 Adjusting part 333 Protrusion 335 Engaging part 500 Specimen inspection system 600 Cartridge device 711 First opening 712 Adjustment part 921 Temperature control part 922 Separation part

Claims

1. A specimen processing system comprising a specimen processing device for performing a process to make a test object in a specimen suitable for testing, a rotation driving device, a discharge / suction device, and a temperature control device, wherein the specimen processing device has a storage member with a disk-shaped upper part and a holding member for holding the storage member, the storage member has a plurality of storage means for storing the specimen and reagents for processing the specimen respectively, the plurality of storage means are provided along the circumference of the disk so as to extend downward of the disk, the storage member is rotatably held by the holding member about the center of the disk, the plurality of storage means include a first storage means for mixing and storing the specimen and the reagent, and a second storage means for storing the reagent, the second storage means being adjacent to the first storage means, the first storage means extends downward further than the second storage means, the rotation driving device rotates the storage member about its center, the discharge / suction device discharges or suctions the specimen or the reagent, the discharge / suction device includes discharge / suction means which moves up and down above the storage member at a predetermined position, the storage member is rotatable such that the plurality of storage means selectively face the predetermined position, the temperature control device has a recess in its upper part capable of accommodating at least one of the storage means, and is movable in the vertical direction at a predetermined position below the storage member of the specimen processing device, A specimen processing system.

2. comprising a cover member for covering the holding member and the storage member from above, the cover member having an opening on its upper surface through which a pipette tip can be inserted, The specimen processing system according to Claim 1.

3. wherein the test object is a nucleic acid and the process is nucleic acid extraction, The specimen processing system according to Claim 1 or 2.

4. wherein the discharge / suction means is a pipette tip, The specimen processing system according to any one of Claims 1 to 3.

5. comprising a separation device, the separation device being movable in the vertical direction at a predetermined position below the storage member of the specimen processing device, The specimen processing system according to any one of Claims 1 to 4.

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