Separation insert, separation tool, and separation method

Abstract

Provided are a separation insert, a separation tool, and a separation method that make it possible to perform isolation with high purity.　A separation insert 20 comprises: an insert body 30 that has a first partition part 40 for partitioning an internal space IS of a container 10 into a first internal space IS1 and a second internal space IS2, and has a support part 60 for supporting the first partition part 40 with respect to the container 10; and a first insert opening that is provided in the first partition part 40, and that allows a separation object liquid to flow at least from either one of the first internal space IS1 or the second internal space IS2 to the other via the first insert opening during a centrifugal separation operation. The insert body 30 is configured such that, in an accommodated state, at least a portion of the insert body 30 can float on the separation object liquid.

Description

Separation insert, separation device, and separation method

[0001] The present invention relates to a separation insert, a separation device, and a separation method.

[0002] One conventional technique proposed for separating specific cells from blood involves centrifuging a centrifuge tube containing blood and a separation solution using a centrifuge with an insert housed in the centrifuge tube (see, for example, Patent Document 1). This insert is configured with a cylindrical body with a closed top surface and an open bottom surface, and an opening on the top surface that allows a fluid to pass through, and is held in a container during the separation operation.

[0003] International Publication No. 2012 / 149641

[0004] In recent years, there has been an increasing need to effectively separate and remove red blood cells with altered properties from blood, even after a predetermined time has elapsed since the blood was collected. However, in the above-mentioned conventional technology, as described above, the insert merely comprises a cylindrical body and an opening on the upper surface of the cylindrical body, and is held in a container during the separation operation. Therefore, when separating specific cells by decantation after centrifugation, there is a risk that red blood cells with altered properties may be mistakenly separated, making it difficult to separate the cells with high purity. Therefore, there is room for improvement in terms of separating the cells with high purity.

[0005] The present invention has been made in view of the above, and an object of the present invention is to provide a separation insert, a separation device, and a separation method that enable separation to be performed with high purity.

[0006] In order to solve the above-mentioned problems and achieve the object, the separation insert according to claim 1 is a separation insert to be accommodated in a container, and when a centrifugation operation is performed on the container containing a liquid to be separated that includes a sample, the separation insert separates components of the sample into a first separated component and a second separated component that is a component other than the first separated component, the container has an open end where an opening is provided and a bottom end provided opposite the open end, and the separation insert divides the internal space of the container into a first internal space which is a space on the bottom end side and in which the first separated component is accommodated after the centrifugation operation, and a second internal space on the open end side The insert body has a partitioning means for separating the first internal space into a second internal space in which the second separated component is contained after the centrifugation operation, and a support means for supporting the partitioning means relative to the container, and an insert opening provided in the partitioning means, which allows the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other through the insert opening during the centrifugation operation, and the insert body is configured so that at least a portion of the insert body can float in the liquid to be separated when the liquid to be separated is contained in the container.

[0007] The separation insert of claim 2 is the separation insert of claim 1, wherein the support means comprises a first support means connected to the partition means, and a second support means formed separately from the first support means and provided closer to the bottom end than the first support means, and capable of supporting the first support means relative to the container, and the insert main body is configured so that in the stored state, the partition means and the first support means can float in the liquid to be separated, and the second support means cannot float in the liquid to be separated.

[0008] The separation insert described in claim 3 is the separation insert described in claim 1 or 2, in which the diameter of the partition means is approximately the same as the inner diameter of the container, and the partition means does not have any cutouts or openings other than the insert opening, thereby making it possible to prevent air located in the first internal space from moving from the first internal space to the second internal space in the stored state.

[0009] The separation insert described in claim 4 is the separation insert described in claim 2, and comprises a second partition provided in the insert main body portion for dividing the first internal space into a bottom-side first internal space, which is the space on the bottom end side, and an opening-side first internal space, which is the space on the opening end side; and a second insert opening provided in the second partition portion, which allows the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other through the second insert opening during the centrifugation operation, and the second partition is provided in the portion on the opening end side of the second support means.

[0010] The separation insert described in claim 5 is the separation insert described in claim 2, wherein the second support means comprises a support main body portion and a flange portion for holding the second support means in a predetermined position, and the flange portion is provided at the end portion of the support main body portion on the bottom end side.

[0011] The separation insert of claim 6 is the separation insert of claim 2, wherein the second support means comprises a substantially cylindrical support main body portion and a flange portion provided over the entire end portion on the opening end side of the support main body portion, the flange portion being for holding the second support means in a predetermined position, and the flange portion is configured so that it protrudes from the end portion on the opening end side of the support main body portion toward the opening end side, and the outer surface of the flange portion approximately conforms to the inner surface of the container.

[0012] The separation insert described in claim 7 is the separation insert described in claim 1 or 2, wherein the insert main body portion is a nozzle portion that protrudes from the partition means toward the bottom end side, and is provided with a nozzle portion that allows the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other through the nozzle portion and the insert opening.

[0013] The separating insert according to an eighth aspect of the present invention is the separating insert according to the seventh aspect, wherein the inner diameter of the nozzle portion is made smaller toward the bottom end portion.

[0014] The separation device described in claim 9 comprises a container having an open end with an opening and a bottom end opposite the open end, and the separation insert described in claim 1 or 2.

[0015] A separation method according to claim 10 is a separation method for separating components of a sample into a first separated component and a second separated component other than the first separated component via a separation insert housed in a container when a centrifugation operation is performed on the container containing a liquid to be separated, the method comprising: using a separation insert housed in a container; the container having an opening end at which an opening is provided and a bottom end provided opposite the opening end; the separation insert having an insert main body portion including a partition means for partitioning an internal space of the container into a first internal space on the bottom end side, the first internal space in which the first separated component is accommodated after the centrifugation operation, and a second internal space on the opening end side, the second internal space in which the second separated component is accommodated after the centrifugation operation; and a support means for supporting the partition means relative to the container; and an insert opening provided in the partition means, and an insert opening that allows the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other through the insert opening during operation, and the separation method includes a dispensing step of dispensing the liquid to be separated into the container, a separation step of separating the components of the sample into the first separated component and the second separated component by performing the centrifugation operation on the container containing the liquid to be separated after the dispensing step, and a separation step of separating the second separated component after the centrifugation step, wherein during the separation step, the first separated component is pushed up toward the open end by at least a part of the insert main body that is floating in the liquid to be separated when the liquid to be separated is contained in the container, thereby moving the first separated component from the second internal space to the first internal space via the insert opening.

[0016] According to the separation insert of claim 1 or the separation instrument of claim 9, the insert body is configured so that at least a portion of the insert body can float in the liquid to be separated when stored. This allows at least a portion of the insert body to float in the liquid to be separated when stored, thereby enabling effective separation of the first and second separated components during centrifugation regardless of the state of the sample. This prevents the first separated component from being mixed with the second separated component when decanting after centrifugation, making it possible to perform separation with high purity.

[0017] According to the separation insert of claim 2, the insert body is configured so that, in the contained state, the partitioning means and the first support means can float in the liquid to be separated, but the second support means cannot float in the liquid to be separated. Therefore, since the partitioning means and the first support means float in the liquid to be separated in the contained state, the first separated component and the second separated component can be effectively separated during centrifugation regardless of the state of the sample. Furthermore, when the liquid to be separated is not contained in the container, the partitioning means and the first support means can be supported by the container via the second support means, which improves the installability of the insert body in the container.

[0018] According to the separation insert described in claim 3, the diameter of the partition means is approximately the same as the inner diameter of the container, and the partition means does not have any cutouts or openings other than the insert openings, which makes it possible to prevent air located in the first internal space from moving from the first internal space to the second internal space in the stored state.Therefore, it is possible to prevent air located in the first internal space from moving from the first internal space to the second internal space in the stored state, and at least a portion of the insert main body can be effectively floated in the liquid to be separated in the stored state.

[0019] According to the separation insert described in claim 4, the second partition portion is provided on the opening end side of the second support means, so that when decantation is performed after centrifugation, it is easier to avoid the first separated components (especially those components of the first separated components that tend to float) from being mixed into the second separated components, compared to when the second partition portion is provided on the bottom end side of the second support means, making it possible to perform separation with high purity.

[0020] According to the separation insert described in claim 5, the flange portion is provided at the end portion on the bottom end side of the support main body portion, so that when a first separated component is present in the gap between the support main body portion and the side wall portion of the container, the first separated component can be prevented from mixing with the second separated component, making it possible to perform separation with high purity, compared to when the flange portion is provided at the end portion on the opening end side of the support main body portion.

[0021] According to the separation insert described in claim 6, the flange portion is configured so that it protrudes from the end portion on the opening end side of the support main body portion toward the opening end side, and so that the outer surface of the flange portion roughly conforms to the inner surface of the container.Therefore, compared to when the flange portion is provided at the end portion on the bottom end side of the support main body portion, it is easier to prevent the first separated component (especially the component of the first separated component that is prone to floating) from mixing with the second separated component when decantation is performed after centrifugation, making it possible to perform separation with high purity.

[0022] According to the separation insert described in claim 7, the insert main body portion is provided with a nozzle portion that protrudes from the partition means toward the bottom end side, so that when stored, air located in the first internal space can be prevented from moving from the first internal space to the second internal space, and at least a portion of the insert main body portion can be effectively floated in the liquid to be separated when stored.

[0023] According to the separation insert of claim 8, the inner diameter of the nozzle portion is made smaller toward the bottom end, so that, according to Newton's law of viscosity, the speed of the liquid to be separated flowing through the nozzle portion increases as it flows toward the bottom end, thereby enabling more effective separation of the first and second separated components during centrifugation compared to when the inner diameter of the nozzle portion is uniform, thereby improving the efficiency of the separation.

[0024] According to the separation method of claim 10, in the separation step, during the centrifugation operation, at least a portion of the insert body floating in the separation target liquid in the accommodated state pushes the first separated component toward the open end, causing the first separated component to move from the second internal space to the first internal space via the insert opening. Therefore, since at least a portion of the insert body floats in the separation target liquid in the accommodated state, the first separated component and the second separated component can be effectively separated during the centrifugation operation regardless of the state of the sample. Therefore, when decantation is performed after the centrifugation operation, it is possible to prevent the first separated component from being mixed with the second separated component, and it is possible to perform separation with high purity.

[0025] 11. FIG. 12 is a front view showing an overview of a separation instrument according to a first embodiment of the present invention. FIG. 13 is a perspective view of the separation instrument of FIG. 1, seen from above. FIG. 14 is a perspective view of the separation instrument of FIG. 1, seen from below. FIG. 15 is a longitudinal sectional view of the separation instrument of FIG. 1. FIG. 16 is a view showing a state in which excess air bubbles have been removed from a container in a dispensing step of a sample separation method. FIG. 17 is a view showing a state in which a separation target liquid has been injected in a dispensing step of a sample separation method. FIG. 18 is a view showing a state in which a centrifugation step of a sample separation method has been performed. FIG. 19 is a front view showing an overview of a separation instrument according to a second embodiment. FIG. 19 is a perspective view of the separation instrument of FIG. 16, seen from above. FIG. 19 is a perspective view of the separation instrument of FIG. 16, seen from below. FIG. 19 is a longitudinal sectional view of the separation instrument of FIG. 17. FIG. 19 is an enlarged view showing the peripheral area of ​​a separation insert in FIG. 11. FIG. 19 is a view showing, among the test results of a performance confirmation test, the results of measurement by a blood cell measuring device performed on a cell suspension centrifuged using whole blood 48 hours after blood collection, as described below. FIG. 19 is a view showing, among the test results of a performance confirmation test, the results of measurement by a blood cell measuring device performed on a cell suspension centrifuged using whole blood 72 hours after blood collection, as described below. 4A and 4B are diagrams showing the results of FCM analysis performed on a cell suspension centrifuged using whole blood 48 hours after blood collection (described below) from the test results of a performance confirmation test.

[0023] Fig. 4B is a diagram showing the results of FCM analysis performed on a cell suspension centrifuged using whole blood 72 hours after blood collection (described below) from the test results of a performance confirmation test. A diagram showing a modified example of the separation insert, illustrating the region corresponding to Fig. 4. A diagram showing a modified example of the separation insert, illustrating the region corresponding to Fig. 4. A diagram showing a modified example of the separation insert, illustrating the region corresponding to Fig. 4. A diagram showing a modified example of the separation insert, illustrating the region corresponding to Fig. 4. A diagram showing a modified example of the separation insert, illustrating the region corresponding to Fig. 4. A diagram showing a modified example of the separation insert, illustrating the region corresponding to Fig. 4.

[0026] Hereinafter, with reference to the accompanying drawings, a detailed description will be given of embodiments of a separation insert, a separation device, and a separation method according to the present invention. First, [I] the basic concept of the embodiment will be described, then [II] specific details of the embodiment will be described, and finally, [III] modifications to the embodiment will be described. However, the present invention is not limited to the embodiment.

[0027] [I] Basic Concept of the Embodiment First, the basic concept of the embodiment will be described. The embodiment generally relates to a separation insert to be accommodated in a container, and when a centrifugation operation is performed on the container containing a liquid to be separated that includes a sample, the separation insert separates the components of the sample into a first separated component and a second separated component that is a component other than the first separated component, a separation device using the separation insert, and a separation method using the separation insert.

[0028] Here, the term "sample" refers to a substance consisting of multiple particles and subjected to testing, analysis, and / or inspection. This sample is a concept that includes, for example, specimens, reagents, and sludge, but in the embodiments, it will be described as a biological sample (specimen) containing multiple cells.

[0029] Furthermore, the term "specimen" refers to a biological sample that is suspected of containing a target substance (or that is tested to determine whether it contains a target substance). This specimen is a concept that includes, for example, clinical specimens (for example, blood such as peripheral blood) and liquids containing physiologically active substances such as low-molecular-weight compounds, but in the embodiments, it will be described as blood.

[0030] Furthermore, the term "reagent" refers to a substance used to detect a substance to be analyzed, and is a concept that includes, for example, magnetic particle reagents, latex particle reagents, and the like.

[0031] Furthermore, "sludge" refers to materials discharged in connection with, for example, the treatment of water supply and sewerage systems or industrial wastewater.

[0032] Furthermore, the term "liquid to be separated" refers to a liquid used for separating a sample. This liquid to be separated includes, for example, a liquid containing only a sample, a liquid containing a sample and a solution (for example, a specific gravity separation liquid and / or a dilution liquid), and the like. In the embodiments, however, the liquid to be separated will be described as a liquid containing a sample and a solution.

[0033] [II] Specific Contents of the Embodiments Next, specific contents of the embodiments will be described.

[0034] [Embodiment 1] First, a description will be given of a separation device according to embodiment 1. In this embodiment 1, a support portion (to be described later) includes a first support portion (to be described later) and a second support portion (to be described later).

[0035] (Configuration) First, the configuration of the separation instrument 1 according to the first embodiment will be described.

[0036] In the following description, the X direction in FIG. 1 is referred to as the left-right direction of the separation instrument 1 (the -X direction is the left direction of the separation instrument 1, and the +X direction is the right direction of the separation instrument 1), the Y direction in FIG. 2 is referred to as the front-to-back direction of the separation instrument 1 (the +Y direction is the front direction of the separation instrument 1, and the -Y direction is the rear direction of the separation instrument 1), and the Z direction in FIG. 1 is referred to as the up-down direction of the separation instrument 1 (the +Z direction is the up direction of the separation instrument 1, and the -Z direction is the down direction of the separation instrument 1).

[0037] The separation device 1 is a device for separating components (e.g., particulate components, etc.) of a sample (specifically, blood), and generally comprises a container 10 and a separation insert 20, as shown in Figures 1 to 3.

[0038] (Configuration - Container) Returning to FIG. 1, the configuration of the container 10 will be described first.

[0039] The container 10 is for containing a sample and a separation insert 20. The container 10 is configured using, for example, a known centrifuge tube, and includes a container body 11, an opening 12, and a lid 13, as shown in FIG.

[0040] (Configuration—Container—Container Body) The container body 11 is the basic structure of the container 10. The container body 11 is formed of a long, hollow body made of resin (or glass), and specifically, the bottom portion 11d of the container body 11 is formed of a hollow body that is approximately conical.

[0041] As shown in FIG. 1, the container body 11 has an opening end 11a where the opening 12 is provided, a bottom end 11b that is provided opposite the opening end 11a, and a side wall portion 11c that is provided between the opening end 11a and the bottom end 11b.

[0042] In the first embodiment, the "bottom portion 11d" corresponds to the portion of the container body 11 that includes the bottom end portion 11b and its vicinity, as shown in FIG.

[0043] The specific shape and size of the container body 11 are arbitrary, but in the first embodiment they are set as follows.

[0044] That is, the planar shape of the container body 11 is set to be a substantially circular ring shape. However, the shape is not limited to this, and may be set to, for example, a ring shape other than a substantially circular ring shape (for example, a rectangular ring shape or a triangular ring shape).

[0045] The inner diameter of the container body 11 is set according to the capacity of the container 10 to contain the liquid to be separated LS shown in Figures 6 and 7, and may be set to approximately 15 mm to 30 mm, for example. However, the inner diameter is not limited to this, and may be set to, for example, less than 15 mm or greater than 30 mm.

[0046] The vertical length of the container body 11 is set according to the capacity of the liquid to be separated LS in the container 10, and may be set to approximately 100 mm to 150 mm, for example. However, the length is not limited to this, and may be set to, for example, less than 100 mm or more than 150 mm.

[0047] (Configuration - Container - Opening) Returning to Figure 1, the opening 12 is for allowing the liquid to be separated LS (specifically, a liquid containing a sample, a specific gravity separation liquid LS1, and a diluent) to flow into and out of the container body 11, and is provided at the opening end 11a as shown in Figure 1.

[0048] The specific shape and size of the opening 12 are arbitrary, but in the first embodiment they are set as follows.

[0049] That is, the shape of the opening 12 is set to be substantially circular, but is not limited to this, and may be set to be, for example, substantially elliptical or substantially polygonal (for example, substantially rectangular).

[0050] The diameter of the opening 12 is set to be approximately the same as the outer diameter of the opening end 11a, but is not limited to this, and may be set to be smaller than the outer diameter of the opening end 11a, for example.

[0051] (Configuration—Container—Lid) The lid 13 serves to seal the opening 12. The lid 13 is formed of a hollow resin body with an open bottom, and as shown in Fig. 1, when the opening 12 is sealed by the lid 13, it is connected to the opening end 11a of the container body 11 and its vicinity by a fitting structure (or a screw structure or a locking structure) or the like.

[0052] The specific shape and size of the lid portion 13 are arbitrary, but in the first embodiment they are set as follows.

[0053] That is, the cross-sectional shape of the lid portion 13 along the XY plane is set to a shape that can fit into the opening end 11a of the container body 11 and its surrounding area, and as one example, is set to a substantially circular ring shape.

[0054] In addition, the inner diameter of the lid portion 13 is set to a size that can fit into the opening end 11a of the container body 11 and its surrounding area, and specifically, is set to be approximately the same as the outer diameter of the opening end 11a of the container body 11.

[0055] In addition, the vertical length of the lid portion 13 is set to a length that can fit into the opening end 11a of the container body 11 and its surrounding area, and as an example, is set to approximately one-eighth to one-sixth of the vertical length of the container body 11.

[0056] (Configuration - Separating Insert) Next, the configuration of the separating insert 20 will be described.

[0057] The separation insert 20 is used to separate the components of the sample into a first separated component S1 in Fig. 7 and a second separated component S2 in Fig. 7 when a centrifugation operation is performed on the container 10 containing a separation target liquid LS containing a sample. The separation insert 20 is formed separately from the container 10 and is contained in the container 10.

[0058] Specifically, as shown in Figure 1, the separation insert 20 is positioned above the bottom portion 11d of the container body 11 in the internal space IS of the container 10 (however, this is not limited to this, and for example, a part of the container body 11 may be positioned in the bottom portion 11d).

[0059] As also shown in FIGS. 1 to 4 , the separator insert 20 includes an insert body 30 , a first insert opening 80 , and a second insert opening 90 .

[0060] (Configuration—Separate Insert—Insert Body) The insert body 30 is the basic structure of the separate insert 20, and as shown in FIG. 4, includes a first partition 40, a second partition 50, a support portion 60, and a nozzle portion .

[0061] Here, the term "centrifugation operation" refers to an operation of centrifuging the container 10 containing the liquid to be separated LS using a known centrifuge or the like.

[0062] Furthermore, the "first separated component S1" refers to the component to be removed among the components of the sample separated by the centrifugation operation, and in the first embodiment, this corresponds to a specific cell contained in the blood (for example, red blood cells, etc.).

[0063] Furthermore, the "second separated component S2" refers to the components of the sample separated by the centrifugation operation other than the first separated component S1, and in the first embodiment, this refers to components including the components to be separated (for example, white blood cells, etc.).

[0064] (Configuration—Separate Insert—Insert Body—First Partition) The first partition 40 is a partitioning means for dividing the internal space IS of the container 10 into a first internal space IS1 and a second internal space IS2. The first partition 40 is formed of a generally plate-like body made of resin (or glass), and more specifically, as shown in FIG. 4, it is formed of a generally plate-like body with a concave shape recessed downward.

[0065] Furthermore, as shown in Figure 4, when the separation insert 20 is housed in the container 10 (hereinafter referred to as the "container housed state"), the first partition portion 40 is located at a position above the bottom portion 11d of the container body 11.

[0066] Here, the "first internal space IS1" refers to the space within the internal space IS of the container 10 on the bottom end 11b side of the container body 11, in which the first separated component S1 is accommodated after the centrifugation operation.

[0067] In embodiment 1, as shown in Figure 1, this first internal space IS1 corresponds to the space within the internal space IS of the container 10 extending from the first partition 40 to the bottom end 11b of the container body 11 when the container is housed.

[0068] Furthermore, the "second internal space IS2" refers to the space within the internal space IS of the container 10 on the side of the opening end 11a of the container body 11, in which the second separated component S2 is accommodated after the centrifugation operation.

[0069] In embodiment 1, as shown in Figure 1, this second internal space IS2 corresponds to the space within the internal space IS of the container 10 in the container storage state, extending from the first partition 40 to the opening end 11a of the container body 11.

[0070] (Configuration—Separate Insert—Insert Body—Second Partition) The second partition 50 divides the first internal space IS1 into a bottom-side first internal space IS1a and an opening-side first internal space IS1b. The second partition 50 is formed of a generally plate-like body made of resin (or glass), and more specifically, as shown in FIG. 4, it is formed of a generally plate-like body with a concave shape that is recessed downward.

[0071] As shown in FIG. 4, the second partition 50 is located above the bottom portion 11d of the container body 11 and below the first partition 40 in the container-stored state.

[0072] Here, the "bottom first internal space IS1a" refers to the space within the first internal space IS1 on the bottom end 11b side of the container body 11, which is the space that mainly contains the first separated component S1 whose properties have not changed after the centrifugation operation.

[0073] In embodiment 1, this bottom first internal space IS1a corresponds to the space within the first internal space IS1 that extends from the second partition 50 to the bottom end 11b of the container body 11 when the container is housed, as shown in Figure 1.

[0074] Furthermore, the "opening-side first internal space IS1b" refers to the space within the first internal space IS1 on the opening end 11a side of the container body 11, which is a space (buffer space) that accommodates the first separated component S1 whose properties have not changed after the centrifugation operation and the first separated component S1 whose properties have changed.

[0075] In the first embodiment, as shown in FIG. 1, this opening-side first internal space IS1b corresponds to the space extending from the first partition 40 to the second partition 50 within the first internal space IS1 in the container-accommodated state.

[0076] (Configuration—Separate Insert—Insert Body—Supporting Portion) The supporting portion 60 is a supporting means for supporting the first partition portion 40 relative to the container 10, and as shown in FIG. 1, includes a first supporting portion 61 and a second supporting portion 62.

[0077] (Configuration—Separate Insert—Insert Body—Supporting Part—First Supporting Part) The first supporting part 61 is part of the basic structure of the supporting part 60. This first supporting part 61 is formed of a substantially cylindrical body made of resin (or glass) with open top and bottom faces, and as shown in FIG. 4, is provided so as to protrude from the first partitioning part 40 toward the bottom end part 11b of the container body 11 (the lower side in FIG. 4), and is connected to the first partitioning part 40.

[0078] (Configuration—Separate insert—Insert main body—Support part—Second support part) The second support part 62 is another part of the basic structure of the support part 60, and enables the first support part 61 to be supported relative to the container 10. This second support part 62 is formed separately from the first support part 61, and as shown in FIG. 4, is provided closer to the bottom end part 11b of the container main body 11 than the first support part 61.

[0079] As shown in FIG. 4 , the second support portion 62 includes a support body portion 63 and a flange portion 64 .

[0080] (Configuration—Separate insert—Insert main body—Support portion—Second support portion—Support main body) The support main body 63 is the basic structure of the second support portion 62. This support main body 63 is formed of a substantially cylindrical body made of resin (or glass) with open top and bottom surfaces, and, as shown in FIG. 4, is provided so as to protrude from the second partition portion 50 toward the open end 11a of the container body 11 (upper side in FIG. 4), and is connected to the second partition portion 50.

[0081] (Configuration—separate insert—insert body—support—second support—flange) The flange 64 is for holding the second support 62 in a predetermined position. This flange 64 is formed of a substantially annular body made of resin (or glass), and as shown in FIG. 4 , is provided so as to protrude from the support body 63 toward the outside of the container 10, and is connected to the support body 63.

[0082] Furthermore, the method of installing the flange portion 64 is arbitrary, but in embodiment 1, as shown in Figure 4, the flange portion 64 is provided at the end of the support main body portion 63 on the bottom end portion 11b side of the container main body 11 (the lower end portion in Figure 4).

[0083] By installing it in this manner, when the first separated component S1 is present in the gap between the support body 63 and the side wall 11c of the container 10, it is possible to prevent the first separated component S1 from mixing with the second separated component S2, compared to when the flange portion 64 is provided at the end of the support body 63 on the opening end 11a side of the container body 11 (the upper end portion in Figure 4), and it is possible to perform separation with high purity.

[0084] (Configuration - Separation insert - Insert body - Nozzle portion) The nozzle portion 70 enables the liquid to be separated LS to flow from at least one of the first internal space IS1 or the second internal space IS2 to the other through the nozzle portion 70 and the first insert opening 80 described below.

[0085] Here, "the liquid to be separated LS flows from at least one of the first internal space IS1 or the second internal space IS2 to the other" is a concept that includes, for example, the liquid to be separated LS flowing from the first internal space IS1 to the second internal space IS2 (i.e., the liquid to be separated LS flows in one direction), the liquid to be separated LS flowing from the second internal space IS2 to the first internal space IS1 (i.e., the liquid to be separated LS flows in the opposite direction to the one direction), and the liquid to be separated LS flowing from the first internal space IS1 to the second internal space IS2 and at the same time from the second internal space IS2 to the first internal space IS1 (i.e., the liquid to be separated LS flows in both the one direction and the opposite direction simultaneously).

[0086] Furthermore, this nozzle portion 70 is formed of an approximately cylindrical body (specifically, an approximately cylindrical circle) made of resin (or glass), and as shown in Figure 4, is arranged so as to protrude from the first partition portion 40 toward the bottom end portion 11b of the container body 11 (the lower side in Figure 4).

[0087] Specifically, the nozzle portion 70 is disposed so that the upper end of the nozzle portion 70 directly communicates with a first insert opening 80 (described later), and is connected to the first partition portion 40 .

[0088] Such a nozzle portion 70 can prevent air located in the first internal space IS1 from moving from the first internal space IS1 to the second internal space IS2 in the storage state described below, and can effectively float at least a portion of the insert main body portion 30 in the liquid to be separated LS in the storage state described below.

[0089] (Configuration—Separate Insert—Insert Body—Other Configurations) The specific configuration of the insert body 30 is arbitrary, but in the first embodiment, it is configured as follows.

[0090] (Configuration - Separation insert - Insert main body - Other configurations - Configuration 1) First, when the liquid to be separated LS is contained in the container 10 (hereinafter referred to as the "contained state"), the insert main body 30 is configured so that at least a portion of the insert main body 30 can float in the liquid to be separated LS.

[0091] Specifically, as shown in Figure 6, in the stored state, the insert main body 30 is configured so that the first partition portion 40 and the first support portion 61 can float in the liquid to be separated LS, and the second support portion 62 cannot float in the liquid to be separated LS.

[0092] In more detail, the first partition section 40, the second partition section 50, the first support section 61, the second support section 62, and the nozzle section 70 are configured as follows.

[0093] (Configuration - Separation insert - Insert main body - Other configurations - Regarding the first partition) That is, first, the planar shape of the first partition 40 is set to be approximately the same as the inner diameter shape of the part other than the bottom part 11d of the container main body 11, and specifically, it is set to be approximately circular.

[0094] The diameter of the first partition 40 is set smaller than the inner diameter of the container body 11 other than the bottom portion 11d.

[0095] Furthermore, the thickness of the first partition 40 is set to a length that allows the first partition 40 to float in the liquid to be separated LS and that ensures the desired strength of the first partition 40, and as an example, may be set to approximately 0.3 mm to 1.0 mm.

[0096] (Configuration - Separation insert - Insert main body - Other configurations - Second partition section) Furthermore, the planar shape of the second partition section 50 is set to be approximately the same as the inner diameter shape of the parts other than the bottom part 11d of the container main body 11, and specifically, it is set to be approximately circular.

[0097] The diameter of the second partition 50 is set to be smaller than the diameter of the first partition 40 .

[0098] The thickness of the second partitioning portion 50 is set to a length that ensures the desired strength of the second partitioning portion 50, and may be set to approximately 0.3 mm to 1.0 mm, for example.

[0099] (Configuration—Separate Insert—Insert Body—Other Configurations—First Support Portion) The planar shape of the first support portion 61 is set to be approximately annular. However, the shape is not limited to this, and may be set to, for example, an annular shape other than approximately annular (for example, a rectangular annular shape or a triangular annular shape).

[0100] The outer diameter of the first support portion 61 is set to be smaller than the diameter of the first partition portion 40 .

[0101] In addition, the vertical length of the first support portion 61 is set to a length that positions the lower end of the first support portion 61 above the second partition portion 50, and as an example, is set to a length that is approximately one-seventh to one-eighth of the vertical length of the container body 11.

[0102] Furthermore, the thickness of the first support portion 61 is set to a length that allows the first support portion 61 to float in the liquid to be separated LS and that ensures the desired strength of the first support portion 61, and as an example, may be set to approximately 0.3 mm to 1.0 mm.

[0103] (Configuration—Separate Insert—Insert Body—Other Configurations—Second Support Section) The planar shape of the support body section 63 of the second support section 62 is set to be a substantially circular ring shape. However, the shape is not limited to this, and may be set to, for example, a ring shape other than a substantially circular ring shape (for example, a rectangular ring shape or a triangular ring shape).

[0104] The outer diameter of the support body 63 of the second support portion 62 is set to be approximately the same as the outer diameter of the first support portion 61 .

[0105] Furthermore, the vertical length of the support body 63 of the second support part 62 is set to be approximately the same as the vertical length of the first support part 61. However, this is not limiting, and for example, the vertical length may be set to be different from the vertical length of the first support part 61.

[0106] The thickness of the support body 63 of the second support portion 62 is set to a length that can ensure the desired strength of the second support portion 62, and may be set to approximately 0.3 mm to 1.0 mm, for example.

[0107] In addition, the outer diameter of the flange 64 of the second support portion 62 is set to a length that enables the second support portion 62 to be held against the container 10, and more specifically, is set to be approximately the same as the inner diameter of the container 10.

[0108] The inner diameter of the flange 64 of the second support portion 62 is set to be approximately the same as the outer diameter of the second support portion 62 .

[0109] Furthermore, the thickness of the flange 64 of the second support portion 62 is set to a length that ensures the desired strength of the flange 64 of the second support portion 62, and may be set to approximately 0.3 mm to 1.0 mm, for example.

[0110] (Configuration—Separate Insert—Insert Body—Other Configurations—Nozzle) The inner diameter of the nozzle 70 is set to become smaller toward the bottom end 11b of the container body 11 (the lower side in FIG. 4).

[0111] Specifically, the inner diameter of the upper end of the nozzle portion 70 is set to be approximately the same as the diameter of the first insert opening 80 described below, and the inner diameter of the lower end of the nozzle portion 70 is set to be smaller than the diameter of the first insert opening 80 described below.

[0112] As a result, due to Newton's law of viscosity, the speed of the liquid to be separated LS flowing inside the nozzle portion 70 can increase as it flows toward the bottom end 11b of the container body 11. Therefore, compared to when the inner diameter of the nozzle portion 70 is uniform, the first separated component S1 and the second separated component S2 can be separated more effectively during the centrifugal separation operation, and the efficiency of the separation can be improved.

[0113] However, the present invention is not limited to this, and the inner diameter of the nozzle portion 70 may be set to be uniform, for example.

[0114] The vertical length of the nozzle portion 70 is set so that the lower end of the nozzle portion 70 is positioned at approximately the same level as the lower end of the first support portion 61 .

[0115] However, the present invention is not limited to this, and the length may be set so that the lower end of the nozzle portion 70 is positioned lower (or higher) than the lower end of the first support portion 61, for example.

[0116] Furthermore, the thickness of the nozzle portion 70 is set to a thickness that allows the first partition portion 40 and the first support portion 61 to float in the liquid to be separated LS, and a length that ensures the desired strength of the nozzle portion 70; for example, it may be set to approximately 0.3 mm to 1.0 mm.

[0117] With this configuration, in the contained state, the first partition 40 and the first support 61 float in the separation target liquid LS, thereby enabling effective separation of the first separated component S1 and the second separated component S2 during centrifugation regardless of the state of the sample (particularly, in the contained state, red blood cells of the first separated component S1 whose specific gravity has changed can be pushed up toward the opening end 11a of the container body 11 by the floating first partition 40 and first support 61, and can be moved to the opening-side first internal space IS1b and / or the bottom-side first internal space IS1a via the first insert opening 80, which can contribute to improving separation efficiency). Furthermore, in a state in which the separation target liquid LS is not contained, the first partition 40 and the first support 61 can be supported by the container 10 via the second support 62, thereby improving the installability of the insert body 30 within the container 10.

[0118] (Configuration - Separate insert - Insert main body - Other configurations - Configuration 2) In addition, the first partition portion 40, the first support portion 61, and the nozzle portion 70 are formed integrally, and the second partition portion 50 and the second support portion 62 (support main body portion 63 and flange portion 64) are formed integrally.

[0119] Specifically, they are integrally formed by injection molding (or molding with a 3D printer) a transparent resin material.

[0120] This allows the separating insert 20 to be constructed easily and quickly, and the manufacturability of the separating insert 20 can be improved.

[0121] However, this is not limited to the above, and for example, after the first partition portion 40, the first support portion 61, the nozzle portion 70, the second partition portion 50, and the second support portion 62 are each formed separately, the first partition portion 40, the first support portion 61, and the nozzle portion 70 may be connected by a fastener or the like, and the second partition portion 50 and the second support portion 62 may be connected by a fastener or the like.

[0122] 2, the first insert opening 80 is an insert opening that, during centrifugation, allows the liquid to be separated LS to flow from at least one of the first internal space IS1 or the second internal space IS2 to the other via the first insert opening 80. At least one first insert opening 80 is provided in the first partition section 40, and specifically, as shown in FIG. 2, only one first insert opening 80 is provided in the approximate center of the first partition section 40 (however, this is not limited to this, and multiple first insert openings may be provided, for example).

[0123] Furthermore, the specific shape and size of the first insert opening 80 are arbitrary, but in the first embodiment they are set as follows.

[0124] That is, the shape of the first insert opening 80 is set to a substantially circular shape. However, the shape is not limited to this, and may be set to, for example, a substantially elliptical shape or a substantially polygonal shape (for example, a substantially rectangular shape).

[0125] The diameter of the first insert opening 80 is set to be smaller than the diameter of the first partition portion 40 .

[0126] (Configuration—Separation Insert—Second Insert Opening) The second insert opening 90 is an opening that, during centrifugation, allows the liquid to be separated LS to flow from at least one of the first internal space IS1 or the second internal space IS2 to the other through the second insert opening 90. At least one second insert opening 90 is provided in the second partition section 50, and specifically, as shown in FIG. 3, only one second insert opening 90 is provided in the approximate center of the second partition section 50 (however, this is not limited to this, and multiple second insert openings 90 may be provided, for example).

[0127] Furthermore, the specific shape and size of the second insert opening 90 are arbitrary, but in the first embodiment they are set as follows.

[0128] That is, the shape of the second insert opening 90 is set to be substantially circular, but is not limited to this, and may be set to be, for example, substantially elliptical or substantially polygonal (for example, substantially rectangular).

[0129] The diameter of the second insert opening 90 is set to be approximately the same as the diameter of the first insert opening 80. However, this is not limiting, and for example, the diameter may be set to be different from the diameter of the first insert opening 80.

[0130] With the separation insert 20 and separation instrument 1 described above, at least a portion of the insert body 30 floats in the liquid to be separated LS when stored, thereby effectively separating the first separated component S1 and the second separated component S2 during centrifugation, regardless of the state of the sample. Therefore, when decantation is performed after centrifugation, it is possible to prevent the first separated component S1 from being mixed with the second separated component S2, making it possible to perform separation with high purity.

[0131] (Sample Separation Method) Next, a sample separation method using the separation instrument 1 according to the first embodiment will be described.

[0132] This separation method is a method for separating components of a sample (e.g., cellular components, etc.) into a first separation component S1 and a second separation component S2 using a separation instrument 1 (particularly, a separation insert 20), and includes a dispensing step, a centrifugation step, and a fractionation step.

[0133] (Sample Separation Method - Dispensing Step) First, the dispensing step will be described.

[0134] The dispensing step is a step of dispensing the separation target liquid LS into the container 10.

[0135] Specifically, first, the separation insert 20 is placed in the container 10, and then the specific gravity separation liquid LS1 is poured into the container 10 using a dispenser (for example, a pipette, etc.) not shown.

[0136] Here, the method for setting the amount of specific gravity separation liquid LS1 poured into container 10 is arbitrary, but in embodiment 1, as shown in Figure 5, the amount is set to be such that the first partition portion 40, the first support portion 61, and the nozzle portion 70 can be floated so that the first support portion 61 and the second support portion 62 are spaced apart.

[0137] Next, the separation device 1 is set in a centrifuge (not shown), and then excess air bubbles in the container 10 are removed using the centrifuge.

[0138] As for the state inside the container 10 when the excess air bubbles are removed, as shown in Figure 5, the first partition 40, the first support 61, and the nozzle 70 are floating in the specific gravity separation liquid LS1, but the second partition 50 and the second support 62 are held in the container 10.

[0139] Next, a liquid LS2 containing a sample and a diluent (specifically, a sample diluted with a diluent; hereinafter referred to as "sample liquid LS2") is poured into the container 10 using a dispenser, thereby dispensing the liquid to be separated LS.

[0140] More specifically, by injecting the sample liquid LS2 into the first insert opening 80 with a pipette, a portion of the injected sample liquid LS2 is contained in the first internal space IS1b on the opening side of the container 10, and another portion of the injected sample liquid LS2 is contained in the second internal space IS2 of the container 10, as shown in Fig. 6 (note that, as shown in Fig. 6, the specific gravity separation liquid LS1 and the sample liquid LS2 are mixed and contained in the first internal space IS1 on the opening side and the second internal space IS2). Thereafter, the first partition member 40, the first support member 61, and the nozzle member 70, which are floating on the liquid to be separated LS, are pushed down to the second support member 62 with the pipette.

[0141] Alternatively, for example, the floating first partition 40, first support 61, and nozzle 70 may be pushed down to the second support 62 with a dispenser before the sample liquid LS2 is injected.

[0142] Here, the method for setting the amount of sample liquid LS2 poured into container 10 is arbitrary, but in embodiment 1, the amount is set so that after the centrifugation process, the interface of the first separated component S1 is at approximately the same position as (or lower than) the first partition section 40.

[0143] (Sample Separation Method - Centrifugation Step) Next, the centrifugation step will be described.

[0144] The centrifugation process is a process that follows the dispensing process, in which the components of the sample are separated into a first separated component S1 and a second separated component S2 by performing a centrifugation operation on the container 10 containing the liquid to be separated LS.

[0145] Specifically, first, the separation instrument 1 is set in a centrifuge, and then the centrifuge is used to perform a centrifugation process for a predetermined time, thereby centrifuging the container 10. Thereafter, the first partition part 40, the first support part 61, and the nozzle part 70, which are floating in the liquid to be separated LS, are pushed down to the second support part 62 by a dispenser.

[0146] As a result, as shown in Figure 7, the first separated component S1 is accommodated in the first internal space IS1 (more specifically, the first separated component S1 whose properties have not changed is accommodated in the bottom-side first internal space IS1a, and the first separated component S1 whose properties have changed is accommodated in the opening-side first internal space IS1b), and the second separated component S2 is accommodated in the second internal space IS2.

[0147] During the above-mentioned centrifugation operation, the first partition 40, the first support 61, and the nozzle 70 float in the liquid to be separated LS, so that the floating red blood cells of the first separated component S1 whose specific gravity has changed can be pushed up toward the opening end 11a of the container body 11 by the first partition 40 and the first support 61, and moved via the first insert opening 80 to the opening side first internal space IS1b and / or the bottom side first internal space IS1a, thereby improving the separation efficiency.

[0148] In addition, the inner diameter of the nozzle portion 70 becomes smaller toward the bottom end 11b of the container body 11, so that the first separated component S1 and the second separated component S2 can be effectively separated during the centrifugation operation, thereby increasing the efficiency of the separation.

[0149] (Sample Separation Method - Fractionation Step) Next, the fractionation step will be described.

[0150] The fractionation step is a step of fractionating and collecting the second separated component S2 after the centrifugation step.

[0151] Specifically, first, the second separated component S2 is removed from the container 10 into another container (not shown) by decantation using a known method.

[0152] The collected second separated component S2 is then added to another container, for example, a known liquid culture medium, and then subjected to a predetermined measurement or analysis process using a known measurement or analysis device (not shown).

[0153] By the separation method described above, the second separated component S2 can be separated with high purity, and the accuracy of the separation can be improved.

[0154] According to the first embodiment, the insert body 30 is configured so that at least a portion of the insert body 30 can float in the liquid to be separated LS in the accommodated state. This allows at least a portion of the insert body 30 to float in the liquid to be separated LS in the accommodated state, thereby enabling effective separation of the first separated component S1 and the second separated component S2 during centrifugation, regardless of the state of the sample. This prevents the first separated component S1 from being mixed with the second separated component S2 during decantation after centrifugation, enabling high-purity fractionation.

[0155] Furthermore, the insert body 30 is configured so that, in the contained state, the first partition 40 and the first support 61 can float in the liquid to be separated LS, but the second support 62 cannot float in the liquid to be separated LS. Therefore, in the contained state, the first partition 40 and the first support 61 float in the liquid to be separated LS, thereby enabling effective separation of the first separated component S1 and the second separated component S2 during centrifugation, regardless of the state of the sample. Furthermore, when the liquid to be separated LS is not contained, the first partition 40 and the first support 61 can be supported by the container 10 via the second support 62, improving the ease of installation of the insert body 30 in the container 10.

[0156] Furthermore, since the flange portion 64 is provided at the end portion on the bottom end 11b side of the support main body portion 63, when the first separated component S1 is present in the gap between the support main body portion 63 and the side wall portion 11c of the container 10, it is possible to prevent the first separated component S1 from mixing with the second separated component S2, compared to when the flange portion 64 is provided at the end portion on the opening end 11a side of the support main body portion 63, and it is possible to perform separation with high purity.

[0157] In addition, the insert main body portion 30 is provided with a nozzle portion 70 that protrudes from the first partition portion 40 toward the bottom end portion 11b, so that when in the stored state, the air located in the first internal space IS1 can be prevented from moving from the first internal space IS1 to the second internal space IS2, and at least a portion of the insert main body portion 30 can be effectively floated in the liquid to be separated LS when in the stored state.

[0158] Furthermore, because the inner diameter of the nozzle portion 70 is made smaller toward the bottom end 11b, the speed of the liquid to be separated LS flowing inside the nozzle portion 70 can be increased as it flows toward the bottom end 11b, according to Newton's law of viscosity. Therefore, compared to when the inner diameter of the nozzle portion 70 is uniform, the first separated component S1 and the second separated component S2 can be separated more effectively during the centrifugal separation operation, and the efficiency of the separation can be improved.

[0159] Furthermore, in the separation step of the separation method, during centrifugation, at least a portion of the insert body 30, which is floating in the liquid to be separated LS in the accommodated state, pushes the first separated component S1 toward the open end 11a, causing the first separated component S1 to move from the second internal space to the first internal space via the first insert opening 80. Therefore, since at least a portion of the insert body 30 floats in the liquid to be separated LS in the accommodated state, the first separated component S1 and the second separated component S2 can be effectively separated during centrifugation regardless of the state of the sample. Therefore, when decantation is performed after centrifugation, it is possible to prevent the first separated component S1 from being mixed with the second separated component S2, and it is possible to perform separation with high purity.

[0160] [Embodiment 2] First, a separation device according to embodiment 2 will be described. In this embodiment 2, the second partition portion is provided on the open end side of the second support portion. However, the configuration of this embodiment 2 is substantially the same as the configuration of embodiment 1, except where otherwise specified. Therefore, the configuration that is substantially the same as the configuration of embodiment 1 will be assigned the same reference numerals and / or names as used in embodiment 1 as necessary, and description thereof will be omitted.

[0161] (Configuration) First, the configuration of the separation instrument 1 according to the second embodiment will be described.

[0162] As shown in FIG. 8, the separation device 1 includes a container 10 and a separation insert 20 .

[0163] (Configuration - Container) First, the configuration of the container 10 will be described.

[0164] The container 10 according to the second embodiment is configured in substantially the same manner as the container 10 according to the first embodiment.

[0165] (Configuration - Separating Insert) Next, the configuration of the separating insert 20 will be described.

[0166] 8 to 12, the separating insert 20 according to the second embodiment is configured in a manner similar to that of the separating insert 20 according to the first embodiment. However, the details of the configuration of the insert body 30 are modified as follows.

[0167] (Configuration—Separate Insert—Insert Body) Returning to FIG. 8, the insert body 30 includes a first partition 40, a second partition 50, a support portion 60, and a nozzle portion 70, as shown in FIGS.

[0168] (Configuration—Separate Insert—Insert Body—First Partition) Returning to FIG. 8, the first partition 40 is provided at a position above the bottom portion 11d of the container body 11 in the container-stored state, as shown in FIG.

[0169] Furthermore, although the specific configuration of the first partition 40 is arbitrary, in embodiment 2, the diameter of the first partition 40 is made approximately the same as the inner diameter of the container 10, and the first partition 40 does not have any cutouts or openings other than the first insert opening 80, thereby making it possible to prevent air located in the first internal space IS1 from moving from the first internal space IS1 to the second internal space IS2 in the stored state.

[0170] Specifically, the diameter of the first partition section 40 is set to be approximately the same as the inner diameter of the container body 11 so that, in the accommodated state, the first partition section 40 and the first support section 61 can float in the liquid to be separated LS.

[0171] As shown in FIGS. 9 and 11, the first partition section 40 is provided with only the first insert opening 80 .

[0172] This configuration of the first partition portion 40 prevents air located in the first internal space IS1 from moving from the first internal space IS1 to the second internal space IS2 when stored, and allows at least a portion of the insert main body portion 30 to be effectively floated in the liquid to be separated LS when stored.

[0173] (Configuration - Separate insert - Insert main body - Second partition) Returning to Figure 10, as shown in Figures 10 to 12, when the container is housed, the second partition 50 is located above the bottom portion 11d of the container main body 11 and below the first partition 40.

[0174] Furthermore, the specific configuration of the second partition section 50 is arbitrary, but in embodiment 2, the second partition section 50 is provided on the opening end 11a side (upper side in Figure 12) of the second support section 62 described below.

[0175] Specifically, as shown in FIG. 12, the second partition portion 50 is provided at an open end 11a of a second support portion 62, which will be described later.

[0176] However, without being limited to this, for example, the second partition portion 50 may be provided in a portion closer to the bottom end 11b (lower side in Figure 12) than the opening end 11a of the second support portion 62 described below, and in a portion closer to the opening end 11a than the vertical center of the second support portion 62 described below.

[0177] With this configuration of the second partition section 50, it is easier to prevent the first separated component S1 (especially the component of the first separated component S1 that is more likely to float) from being mixed into the second separated component S2 when decantation is performed after centrifugation, compared to when the second partition section 50 is provided on the bottom end 11b side of the second support section 62 described below, making it possible to perform separation with high purity.

[0178] (Configuration—Separate Insert—Insert Body—Support Portion) Returning to FIG. 8, the support portion 60 includes a first support portion 61 and a second support portion 62, as shown in FIGS.

[0179] (Configuration—Separate Insert—Insert Body—Support Portion—First Support Portion) The first support portion 61 according to the second embodiment is configured in substantially the same manner as the first support portion 61 according to the first embodiment.

[0180] (Configuration - Separate insert - Insert main body portion - Support portion - Second support portion) The second support portion 62 is formed separately from the first support portion 61, and as shown in Figures 11 and 12, is provided closer to the bottom end portion 11b of the container main body 11 than the first support portion 61, and is provided with a support main body portion 63 and a flange portion 64.

[0181] (Configuration—Separate Insert—Insert Body—Support Portion—Second Support Portion—Support Body) The support body 63 according to the second embodiment is configured in substantially the same manner as the support body 63 according to the first embodiment.

[0182] (Configuration - Separate insert - Insert main body - Support part - Second support part - Flange part) Returning to Figure 8, the flange part 64 is provided over the entire end part on the opening end 11a (upper end part in Figure 8) side of the support main body part 63, as shown in Figures 8 to 12.

[0183] Furthermore, the specific configuration of the flange portion 64 is arbitrary, but in embodiment 2, the flange portion 64 is configured so that it protrudes from the end of the support main body portion 63 on the opening end 11a side toward the opening end 11a side, and so that the outer surface of the flange portion 64 roughly conforms to the inner surface of the container 10.

[0184] Specifically, first, the cross-sectional shape of the flange portion 64 along the XZ plane is set to a generally convex shape that protrudes upward, as shown in FIG.

[0185] The outer diameter of the flange 64 is approximately the same as the inner diameter of the container body 11, and the entire outer diameter of the flange 64 is set to be approximately uniform.

[0186] The inner diameter of the flange 64 is set to be smaller than the outer diameter of the flange 64 and to increase upward. However, this is not limiting, and for example, the inner diameter of the flange 64 may be set to be uniform over substantially the entire flange 64.

[0187] With this type of flange 64, it is easier to prevent the first separated component S1 (especially the component of the first separated component S1 that is more likely to float) from mixing with the second separated component S2 when decantation is performed after centrifugation, compared to when the flange 64 is provided at the end on the bottom end 11b side of the support main body 63, making it possible to perform separation with high purity.

[0188] In this case, for example, as shown in FIG. 12, the lower end portion and the portion thereof of the first support portion 61 may be processed so as to fit into the flange portion 64.

[0189] (Configuration—Separate Insert—Insert Body—Nozzle) The nozzle 70 according to the second embodiment is configured in substantially the same manner as the nozzle 70 according to the first embodiment.

[0190] With the separation insert 20 and separation instrument 1 described above, similar to the separation insert 20 and separation instrument 1 according to the first embodiment, at least a portion of the insert body 30 floats in the liquid LS to be separated in the stored state, thereby effectively separating the first separated component S1 and the second separated component S2 during the centrifugation operation, regardless of the state of the sample. Therefore, when decantation is performed after the centrifugation operation, it is possible to prevent the first separated component S1 from being mixed with the second separated component S2, and it is possible to perform separation with high purity.

[0191] (Sample Separation Method) Next, the sample separation method using the separation instrument 1 according to the second embodiment is similar to the separation method according to the first embodiment, and therefore, description thereof will be omitted.

[0192] (Examples) Examples of implementations using the separation insert of the present invention (specifically, examples in which performance confirmation tests were conducted) will be described below in detail, although the present invention is not limited to the content of the following examples.

[0193] (Example of Implementation - Test Outline) First, an outline of the performance confirmation test will be explained.

[0194] The "performance confirmation test" is a test to confirm the purity of the fraction obtained when the separation target liquid LS is separated using various separation inserts.

[0195] (Examples - Test overview - Details of the configuration of various separation inserts) In addition, the various separation inserts used in the performance confirmation test are divided into two types (hereinafter referred to as "fixed cell separation inserts" and "suspension cell separation inserts").

[0196] Of these, the immobilized cell separation insert used had the same configuration as the separation insert described in the above-mentioned WO 2012 / 149641.

[0197] The suspension-type cell separation insert used had the same configuration as the separation insert 10 according to the second embodiment.

[0198] (Example of implementation - Test outline - Test method) The test method for this performance confirmation test is optional, but will be as follows:

[0199] As will be described later, the test method for the suspension cell separation insert was based on the sample separation method according to the present invention.

[0200] Furthermore, for sample solution LS2 described below, a sample solution containing three different whole blood specimens (hereinafter referred to as "Sample 1," "Sample 2," and "Sample 3") collected from different donors was used, and performance confirmation tests were conducted on each of these three sample solutions.

[0201] Regarding the details of the test method for the above performance confirmation test, first, 15 mL of specific gravity separation liquid LS1 was dispensed into a first container (same configuration as container 10) containing a fixed-type cell separation insert and a second container (same configuration as container 10) containing a floating-type cell separation insert.

[0202] Next, the first container and the second container were centrifuged under predetermined conditions (1200×g, 5 minutes, room temperature) using a centrifuge.

[0203] Next, 8 mL of sample solution LS2 (a whole blood sample 48 or 72 hours after collection, diluted 2-fold with 2% FBS (fetal bovine serum)-PBS (phosphate buffered saline)) was injected through the open end of the fixed cell separation insert in the first container. Furthermore, with the suspension cell separation upper insert (first partition 40, first support 61, and nozzle 70) floating in the second container, the sample solution LS2 was injected through the opening 80 of the upper insert, and then the floating suspension cell separation upper insert was pushed down to the suspension cell separation lower insert (second partition 50 and second support 62) with a disposable pipette.

[0204] Next, the first and second containers were centrifuged using a centrifuge under predetermined conditions (1200 × g, 10 minutes, room temperature) with the brake on. After the centrifugation of the second container, a portion of the second separation insert that had floated (the first partition 40, the first support 61, and the nozzle 70) was pushed down to the other portion of the second separation insert (the second partition 50 and the second support 62) using a disposable pipette.

[0205] Next, in each of the first and second containers, the supernatant containing the cells to be collected that was contained in the upper part of the first separation insert (or the second separation insert) was decanted into a separate container, and then cell counts were performed on the supernatants using a blood cell counter (a blood cell counter manufactured by HORIBA).

[0206] The supernatants collected from the first container and the second container were centrifuged, and the pellets (precipitates after centrifugation (specifically, separated human peripheral blood mononuclear cells (PBMCs))) in FCM (flow cytometer) tubes were suspended by adding 100 μL of a first liquid (phosphate buffered saline (PBS)).

[0207] Next, 5 μL of a reagent (Human TruStain FcX manufactured by BioLegend) for preventing antibody binding and the like was added to each FCM tube, and the FCM tube was then allowed to stand at room temperature for 10 minutes.

[0208] Next, the first liquid was added, and then the mixture was centrifuged under predetermined conditions (500×g, 5 minutes, room temperature) using a centrifuge.

[0209] Next, after removing the supernatant, 20 μL of antibody solution (Multicolor TBNK antibody solution manufactured by BD Biosciences) was added to each well, mixed by vortexing, and then allowed to stand in a refrigerator (2-8° C.) for 30 minutes.

[0210] After stirring, 4.5 mL of the second liquid (0.2% BSA (bovine serum albumin)-PBS) was added to each well, followed by centrifugation under predetermined conditions (500×g, 5 minutes, room temperature).

[0211] Next, after removing the supernatant, 500 μL of 0.2% BSA-PBS was added to the pellet in the FCM tube and suspended therein, and the cell suspension separated in each separation insert was obtained.

[0212] Subsequently, analysis (hereinafter referred to as "FCM analysis") was performed using a flow cytometer (manufactured by BD Biosciences).

[0213] (Example of Implementation - Detailed Test Results of Performance Confirmation Test) Next, the detailed test results of the performance confirmation test will be described.

[0214] The results of the performance confirmation test were as follows:

[0215] 13 and 14, regardless of the type of sample (specifically, the first, second, or third sample) or the time elapsed since collection, the ratio of lymphocytes to white blood cells contained in the supernatant contained in the second container was higher than the ratio of lymphocytes to white blood cells contained in the supernatant contained in the first container. Furthermore, regardless of the type of sample, the ratio of granulocytes to white blood cells contained in the supernatant contained in the second container was lower than the ratio of granulocytes to white blood cells contained in the supernatant contained in the first container.

[0216] First, regarding the analysis results of the FCM analysis shown in Figures 15 and 16, regardless of the type of sample (specifically, the first sample, the second sample, and the third sample) and the time elapsed since blood collection, the ratios of various components to be separated (specifically, CD (Cluster of Differentiation) 3, CD4, CD8, CD19, and CD16 / 56-positive cells) to lymphocytes separated using the suspension-type cell separation insert were higher than the ratios of various components to be separated (specifically, CD3, CD4, CD8, CD19, and CD16 / 56-positive cells) to lymphocytes separated using the fixed-type cell separation insert.

[0217] CD3 is a component of the T cell receptor and is a unique marker common to T cells. CD4 is a transmembrane glycoprotein and is a marker expressed on helper T cells, most thymocytes, monocytes, macrophages, and dendritic cells. CD4 plays an important role in the development and activation of helper T cells. CD8 is a marker for cytotoxic T cells (killer T cells). CD19 is a glycoprotein marker involved in the development, activation, differentiation, and antibody production of B cells. CD16 is a marker present on resting NK cells. CD56 is a marker whose expression is increased on activated NK cells.

[0218] These test results (specifically, the analysis results by FCM analysis shown in Figures 15 and 16) confirmed the effectiveness of using the separation insert 10 of the present invention, as the components to be separated can be effectively separated by using a suspension-type cell separation insert.

[0219] (Effects of embodiment 2) Thus, according to embodiment 2, by making the diameter of the first partition 40 approximately the same as the inner diameter of the container 10 and by not providing the first partition 40 with any cutouts or openings other than the first insert opening 80, it is possible to prevent air located in the first internal space IS1 in the storage state from moving from the first internal space IS1 to the second internal space IS2. Therefore, it is possible to prevent air located in the first internal space IS1 in the storage state from moving from the first internal space IS1 to the second internal space IS2, and at least a portion of the insert main body 30 can be effectively floated in the liquid to be separated LS in the storage state.

[0220] Furthermore, since the second partition 50 is provided on the opening end 11a side of the second support part 62, it is easier to prevent the first separated component S1 (especially the component of the first separated component S1 that is more likely to float) from being mixed into the second separated component S2 when decantation is performed after centrifugation, compared to when the second partition 50 is provided on the bottom end 11b side of the second support part 62, making it possible to perform separation with high purity.

[0221] Furthermore, the flange portion 64 is configured so that it protrudes from the end of the support main body portion 63 on the opening end 11a side toward the opening end 11a side, and so that the outer surface of the flange portion 64 roughly conforms to the inner surface of the container 10. Therefore, compared to when the flange portion 64 is provided at the end of the support main body portion 63 on the bottom end 11b side, it is easier to prevent the first separated component S1 (especially the component of the first separated component S1 that is prone to floating) from mixing with the second separated component S2 when decantation is performed after centrifugation, making it possible to perform separation with high purity.

[0222] [III] Modifications to the Embodiments The embodiments of the present invention have been described above, but the specific configurations and means of the present invention can be modified and improved as desired within the scope of the technical ideas of each invention as set forth in the claims. Such modifications will be described below.

[0223] (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 those described above, and the present invention may solve problems not described above or achieve effects not described above, or may solve only some of the problems described or achieve only some of the effects described.

[0224] (Regarding shape, numerical values, structure, and time series) The shape, numerical values, or interrelationships between the structure or time series of multiple components of the components illustrated in the embodiments and drawings can be modified and improved as desired within the scope of the technical concept of the present invention.

[0225] (Regarding the Separation Device) In the above-mentioned first and second embodiments, it has been described that the container 10 and the separation insert 20 are formed separately, but this is not limited thereto, and for example, the container 10 and the separation insert 20 may be formed integrally.

[0226] As an example, the container 10 and the separation insert 20 may be integrally formed by molding a resin material using a 3D printer.

[0227] (Regarding the container) In the above-mentioned embodiments 1 and 2, it has been described that the bottom portion 11d of the container body 11 is formed of a hollow body having an approximately conical shape, but this is not limited thereto, and for example, the bottom portion 11d of the container body 11 may be formed of a hollow body having an approximately hemispherical shape.

[0228] (Regarding the separation insert) In the above-mentioned embodiments 1 and 2, the separation insert 20 is described as having the second partition portion 50 and the second insert opening 90, but this is not limited thereto, and for example, the second partition portion 50 and the second insert opening 90 may be omitted.

[0229] (Regarding the first partition section and the second partition section) In the above-mentioned embodiments 1 and 2, the first partition section 40 and the second partition section 50 are described as being formed from a concave, approximately plate-like body that is recessed downward, but this is not limited to this and they may be formed, for example, from a substantially flat, approximately plate-like body.

[0230] (Regarding the support portion) In the above-mentioned embodiment 1, it was explained that the vertical length of the support portion 60 (first support portion 61 and second support portion 62) is set to approximately one-fourth the vertical length of the container body 11, but this is not limited to this.

[0231] For example, as shown in Figures 17 and 18, the vertical length of the support part 60 may be set to be shorter than the vertical length of the support part 60 in embodiment 1 (for example, approximately half the vertical length of the support part 60).

[0232] In this case, for example, as shown in Figure 17, the nozzle portion 70 may be arranged so that the upper end of the nozzle portion 70 is directly connected to the first insert opening 80, and the lower end of the nozzle portion 70 is directly connected to the first insert opening 80.

[0233] Also, as shown in Figure 18, the nozzle portion 70 may be arranged so that the vertical length of the nozzle portion 70 is shorter than the vertical length of the nozzle portion 70 in Figure 17, so that the upper end of the nozzle portion 70 is directly connected to the first insert opening 80, but the lower end of the nozzle portion 70 is not directly connected to the first insert opening 80.

[0234] Alternatively, the vertical length of the support portion 60 may be set to be longer than the vertical length of the support portion 60 according to the first embodiment.

[0235] In addition, in the first embodiment, the support portion 60 is described as including the first support portion 61 and the second support portion 62, but this is not limiting. For example, instead of the second support portion 62, the support portion 60 may include a first support portion 61 having the same configuration as the second support portion 62 or a first support portion 61 having a different configuration.

[0236] As an example, the support portion 60 may include the first support portion 61 of FIG. 17 and the first support portion 61 of FIG.

[0237] In addition, in the first embodiment, the support body 63 of the second support part 62 is described as being formed of a generally cylindrical body, but this is not limiting. For example, the support body 63 may include a plurality of legs that protrude from the lower end of the first support part 61 toward the bottom end 11b of the container body 11 and are spaced apart from one another, and an annular connecting part that connects the plurality of legs.

[0238] In this case, for example, flanges 64 may be provided on the outer edge portions of the multiple legs.

[0239] (Regarding the Nozzle Portion) In the above-described first embodiment, the nozzle portion 70 is described as being provided in the first partition portion 40, but this is not limiting, and for example, the nozzle portion 70 may be omitted as shown in FIGS. 19 and 20 .

[0240] In this case, for example, as shown in FIG. 19, the flange portion 64 may be provided at the end of the support body portion 63 on the side of the open end 11a of the container body 11 (the upper end portion in FIG. 19).

[0241] Furthermore, as shown in Figure 20, the insert body 30 may be configured so that the entire insert body 30 can float in the liquid to be separated LS by further omitting the flange portion 64 and the second support portion 62.

[0242] (Regarding the flange portion) In the above-mentioned embodiment 1, it has been described that the flange portion 64 is provided at the end of the support main body portion 63 on the bottom end portion 11b side of the container main body 11, but this is not limited thereto, and for example, as shown in Figure 21, the flange portion 64 may be provided at the end of the support main body portion 63 on the opening end portion 11a side of the container main body 11 (the upper end portion in Figure 21).

[0243] (Additional Note) The separation insert of Additional Note 1 is a separation insert to be accommodated in a container, and when a centrifugation operation is performed on the container containing a liquid to be separated, the separation insert separates components of the sample into a first separated component and a second separated component that is a component other than the first separated component, via the separation insert, and the container has an opening end where an opening is provided and a bottom end provided opposite the opening end, and the separation insert divides the internal space of the container into a first internal space which is a space on the bottom end side and in which the first separated component is accommodated after the centrifugation operation, and a second internal space which is a space on the opening end side, The insert body has a partitioning means for separating the first internal space from the second internal space after the centrifugation operation and a support means for supporting the partitioning means relative to the container, and an insert opening provided in the partitioning means that allows the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other through the insert opening during the centrifugation operation, and the insert body is configured so that at least a portion of the insert body can float in the liquid to be separated when the liquid to be separated is contained in the container.

[0244] The separation insert of Appendix 2 is the separation insert described in Appendix 1, wherein the support means comprises a first support means connected to the partition means, and a second support means formed separately from the first support means and provided closer to the bottom end than the first support means, and capable of supporting the first support means relative to the container, and the insert main body is configured so that in the stored state, the partition means and the first support means can float in the liquid to be separated, and the second support means cannot float in the liquid to be separated.

[0245] The separation insert of Appendix 3 is the separation insert described in Appendix 2, in which the diameter of the partition means is approximately the same as the inner diameter of the container, and the partition means does not have any cutouts or openings other than the insert opening, thereby making it possible to prevent air located in the first internal space from moving from the first internal space to the second internal space in the stored state.

[0246] The separation insert of Appendix 4 is the separation insert described in Appendix 2, wherein the separation insert comprises a second partition provided in the insert body portion for dividing the first internal space into a bottom-side first internal space, which is the space on the bottom end side, and an opening-side first internal space, which is the space on the opening end side; and a second insert opening provided in the second partition portion, which allows the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other through the second insert opening during the centrifugation operation, and the second partition is provided in a portion of the second support means on the opening end side.

[0247] The separation insert of Appendix 5 is the separation insert described in Appendix 2, wherein the second support means comprises a support body portion and a flange portion for holding the second support means in a predetermined position, and the flange portion is provided at the end of the support body portion on the bottom end side.

[0248] The separation insert of Appendix 6 is the separation insert described in Appendix 2, wherein the second support means comprises a substantially cylindrical support main body portion and a flange portion provided over the entire end portion of the support main body portion on the opening end side, the flange portion being for holding the second support means in a predetermined position, and the flange portion is configured so that it protrudes from the end portion on the opening end side of the support main body portion toward the opening end side, and the outer surface of the flange portion roughly conforms to the inner surface of the container.

[0249] The separation insert of Appendix 7 is the separation insert described in Appendix 1 or 2, wherein the insert main body portion is a nozzle portion that protrudes from the partition means toward the bottom end side, and is provided with a nozzle portion that allows the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other through the nozzle portion and the insert opening.

[0250] The separation insert of Supplementary Note 8 is the separation insert of Supplementary Note 7, wherein the inner diameter of the nozzle portion is made smaller toward the bottom end portion.

[0251] The separation device of Supplementary Note 9 comprises a container having an open end with an opening and a bottom end opposite the open end, and the separation insert of Supplementary Note 1 or 2.

[0252] The separation method of Supplementary Note 10 is a separation method for separating components of a sample into a first separated component and a second separated component other than the first separated component via a separation insert accommodated in a container when a centrifugation operation is performed on the container containing a liquid to be separated, the method using a separation insert accommodated in the container, the container having an open end where an opening is provided and a bottom end provided opposite the open end, the separation insert comprising an insert main body having a partition means for partitioning an internal space of the container into a first internal space which is a space on the bottom end side and in which the first separated component is accommodated after the centrifugation operation, and a second internal space which is a space on the open end side and in which the second separated component is accommodated after the centrifugation operation, and a support means for supporting the partition means relative to the container, and an insert opening provided in the partition means, and an insert opening that allows the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other through the insert opening. The separation method includes a dispensing step of dispensing the liquid to be separated into the container, a separation step of separating the components of the sample into the first separated component and the second separated component by performing the centrifugation operation on the container containing the liquid to be separated after the dispensing step, and a separation step of separating the second separated component after the centrifugation step. During the separation step, the first separated component is pushed up toward the open end by at least a part of the insert main body that is floating in the liquid to be separated when the liquid to be separated is contained in the container, thereby moving the first separated component from the second internal space to the first internal space via the insert opening.

[0253] (Effects of the Supplementary Note) According to the separation insert described in Supplementary Note 1 or the separation instrument described in Supplementary Note 6, the insert body is configured so that at least a portion of the insert body can float in the liquid to be separated when stored. Since at least a portion of the insert body floats in the liquid to be separated when stored, the first separated component and the second separated component can be effectively separated during centrifugation regardless of the state of the sample. Therefore, when decantation is performed after centrifugation, it is possible to prevent the first separated component from being mixed with the second separated component, and it is possible to perform separation with high purity.

[0254] According to the separation insert described in Appendix 2, the insert body is configured so that, in the contained state, the partitioning means and the first support means can float in the liquid to be separated, but the second support means cannot float in the liquid to be separated. Therefore, since the partitioning means and the first support means float in the liquid to be separated in the contained state, the first separated component and the second separated component can be effectively separated during centrifugation regardless of the state of the sample. Furthermore, when the liquid to be separated is not contained in the container, the partitioning means and the first support means can be supported by the container via the second support means, which improves the installability of the insert body in the container.

[0255] According to the separation insert described in Appendix 3, the diameter of the partition means is approximately the same as the inner diameter of the container, and the partition means does not have any cutouts or openings other than the insert openings, which makes it possible to prevent air located in the first internal space from moving from the first internal space to the second internal space in the stored state.Therefore, it is possible to prevent air located in the first internal space from moving from the first internal space to the second internal space in the stored state, and at least a portion of the insert main body can be effectively floated in the liquid to be separated in the stored state.

[0256] According to the separation insert described in Appendix 4, the second partition is provided on the opening end side of the second support means, so that when decantation is performed after centrifugation, it is easier to avoid the first separated components (especially those of the first separated components that tend to float) from being mixed into the second separated components, compared to when the second partition is provided on the bottom end side of the second support means, making it possible to perform separation with high purity.

[0257] According to the separation insert described in Appendix 5, the flange portion is provided at the end portion on the bottom end side of the support main body portion. Therefore, compared to when the flange portion is provided at the end portion on the opening end side of the support main body portion, if a first separated component exists between the partition means and the flange portion, the first separated component can be prevented from mixing with the second separated component, making it possible to separate and collect with high purity.

[0258] According to the separation insert described in Appendix 6, the flange portion is configured so that it protrudes from the end portion on the open end side of the support body portion toward the open end side, and so that the outer surface of the flange portion roughly conforms to the inner surface of the container.Therefore, compared to when the flange portion is provided at the end portion on the bottom end side of the support body portion, it is easier to prevent the first separated component (especially the component of the first separated component that is prone to floating) from mixing with the second separated component when decantation is performed after centrifugation, making it possible to perform separation with high purity.

[0259] According to the separation insert described in Appendix 7, the insert main body portion is provided with a nozzle portion that protrudes from the partition means toward the bottom end side, so that when stored, air located in the first internal space can be prevented from moving from the first internal space to the second internal space, and at least a portion of the insert main body portion can be effectively floated in the liquid to be separated when stored.

[0260] According to the separation insert described in Appendix 8, the inner diameter of the nozzle portion is made smaller toward the bottom end, so that, according to Newton's law of viscosity, the speed of the liquid to be separated flowing through the nozzle portion increases as it flows toward the bottom end. Therefore, compared to when the inner diameter of the nozzle portion is uniform, the first and second separated components can be separated more effectively during the centrifugation operation, and the efficiency of the separation can be improved.

[0261] According to the separation method described in Appendix 10, in the separation step, during the centrifugation operation, at least a portion of the insert body floating in the separation target liquid in the accommodated state pushes the first separated component toward the open end, thereby moving the first separated component from the second internal space to the first internal space via the insert opening. Therefore, since at least a portion of the insert body floats in the separation target liquid in the accommodated state, the first separated component and the second separated component can be effectively separated during the centrifugation operation regardless of the state of the sample. Therefore, when decantation is performed after the centrifugation operation, it is possible to prevent the first separated component from being mixed with the second separated component, and it is possible to perform fractionation with high purity.

[0262] DESCRIPTION OF SYMBOLS 1 Separation tool 10 Container 11 Container body 11a Opening end 11b Bottom end 11c Side wall 11d Bottom portion 12 Opening 13 Lid 20 Separation insert 30 Insert body 40 First partition 50 Second partition 60 Support 61 First support 62 Second support 63 Support body 64 Collar 70 Nozzle 80 First insert opening 90 Second insert opening IS Internal space IS1 First internal space IS1a Bottom-side first internal space IS1b Opening-side first internal space IS2 Second internal space LS Liquid to be separated LS1 Gravity separation liquid LS2 Sample liquid S1 First separated component S2 Second separated component

Claims

1. A separation insert housed in a container, wherein when a centrifugation operation is performed on the container containing a liquid to be separated, the separation insert separates the components of the sample into a first separation component and a second separation component which is a component other than the first separation component, The aforementioned container is An opening end is provided, It has a bottom end that is provided opposite to the opening end, The separation insert is, An insert body having a partitioning means for dividing the internal space of the container into a first internal space which is the space on the bottom end side and contains the first separated component after the centrifugal separation operation, and a second internal space which is the space on the opening end side and contains the second separated component after the centrifugal separation operation, and a support means for supporting the partitioning means with respect to the container, The partition means includes an insert opening that, during the centrifugal separation operation, allows the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other through the insert opening, In the container in which the liquid to be separated is contained, the insert body is configured such that at least a portion of the insert body can float on the liquid to be separated. The aforementioned support means is A first support means connected to the partition means, A second support means is formed separately from the first support means and is provided on the bottom end side of the first support means, and is capable of supporting the first support means with respect to the container, In the aforementioned containment state, the insert body is configured such that the partition means and the first support means can float in the liquid to be separated, and the second support means cannot float in the liquid to be separated. Separation insert.

2. The diameter of the partition means is made substantially the same as the inner diameter of the container, and the partition means is not provided with any notches or openings other than the insert opening, thereby making it possible to suppress the movement of air located in the first internal space from the first internal space to the second internal space in the containment state. The separation insert according to claim 1.

3. The separation insert is A second partition portion provided in the insert body portion, which divides the first internal space into a bottom-side first internal space which is the space on the bottom end side and an opening-side first internal space which is the space on the opening end side, The second insert opening provided in the second partition allows the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other during the centrifugal separation operation, The second partition is provided on the portion of the second support means that is on the side of the open end. The separation insert according to claim 1.

4. The second support means is Support body and The second support means comprises a flange for holding it in a predetermined position, The flange portion is provided at the end of the support body portion on the bottom end side. The separation insert according to claim 1.

5. The second support means is A roughly cylindrical support body, A flange portion provided over the entire end of the support body on the open end side, comprising a flange portion for holding the second support means in a predetermined position, The flange portion is configured such that it protrudes from the end of the support body on the open end side toward the open end side, and the outer surface of the flange portion substantially conforms to the inner surface of the container. The separation insert according to claim 1.

6. The insert body is a nozzle portion provided so as to protrude from the partition means toward the bottom end, and the nozzle portion is provided so as to allow the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other through the nozzle portion and the insert opening. The separation insert according to claim 1.

7. The inner diameter of the nozzle portion is made smaller towards the bottom end, The separation insert according to claim 6.

8. A container having an opening end provided with an opening and a bottom end provided opposite to the opening end, A separation insert according to claim 1 or 2, A separation device equipped with the following features.

9. A separation method for separating the components of a sample into a first separation component and a second separation component which is a component other than the first separation component, when a centrifugal separation operation is performed on a container containing a liquid to be separated, which contains a sample, using a separation insert housed in the container, the separation insert being used. The aforementioned container is An opening end is provided, It has a bottom end that is provided opposite to the opening end, The aforementioned separation insert is An insert body having a partitioning means for dividing the internal space of the container into a first internal space which is the space on the bottom end side and contains the first separated component after the centrifugal separation operation, and a second internal space which is the space on the opening end side and contains the second separated component after the centrifugal separation operation, and a support means for supporting the partitioning means with respect to the container, The partition means includes an insert opening that, during the centrifugal separation operation, allows the liquid to be separated to flow from at least one of the first internal space or the second internal space to the other through the insert opening, The aforementioned support means is A first support means connected to the partition means, A second support means is formed separately from the first support means and is provided on the bottom end side of the first support means, and is capable of supporting the first support means with respect to the container, In the container in which the liquid to be separated is contained, the insert body is configured such that the partition means and the first support means can float on the liquid to be separated, and the second support means cannot float on the liquid to be separated. The separation method is A dispensing step of dispensing the liquid to be separated into the container, A separation step is performed after the dispensing step, by performing the centrifugation operation on the container containing the liquid to be separated, thereby separating the components of the sample into a first separation component and a second separation component. The process includes, after the centrifugation step, a separation step for separating the second separated component, In the separation step, during the centrifugal separation operation, the first separation component is pushed upward toward the opening end by at least a portion of the insert body that is floating in the liquid to be separated in the containment state, thereby moving the first separation component from the second internal space to the first internal space via the insert opening. Separation method.