Separation insert, separation device, 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

Technical Field

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

Background Art

[0002] Conventionally, as one of the techniques for performing a fractionation operation for separating specific cells from blood, a technique has been proposed in which, with an insert housed in a centrifuge tube, the centrifuge tube containing blood and a separation liquid is centrifuged using a centrifuge (see, for example, Patent Document 1). Further, this insert is configured to include a cylindrical body having a closed upper surface and an open lower surface, and an opening provided on this upper surface that allows fluid to pass through, and is held in a container during the fractionation operation.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] By the way, in recent years, there has been an increasing need to effectively separate and remove red blood cells with changed properties in the blood even when a predetermined time has elapsed since the blood was collected. However, in the above conventional technique, as described above, the insert only includes a cylindrical body and an opening provided on the upper surface of the cylindrical body, and is merely held in a container during the fractionation operation. Therefore, when fractionating specific cells by decantation after centrifugation, there is a risk that red blood cells with changed properties may be erroneously fractionated, making it difficult to perform high-purity fractionation. Thus, there was room for improvement from the viewpoint of performing high-purity fractionation.

[0005] The present invention has been made in view of the above, and aims to provide a separation insert, a separation device, and a separation method that enable separation with high purity. [Means for solving the problem]

[0006] To solve the above-mentioned problems and achieve the objective, the separation insert described in claim 1 is a separation insert housed in a container, which, when a centrifugal separation operation is performed on the container containing a liquid to be separated containing a sample, 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, wherein the container has an open end with an opening and a bottom end provided opposite to the open end, and the separation insert comprises a first internal space which is the space on the bottom end side and which houses the first separation component after the centrifugal separation operation, and an internal space which is the space on the open end side. The insert body has a partitioning means for dividing a second internal space, which is between the first and second internal spaces, into which the second separated component is contained after the centrifugal separation operation, and a support means for supporting the partitioning means with respect 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 centrifugal separation operation, and the insert body is configured such that at least a part of the insert body can float on the liquid to be separated when the container is filled with the liquid to be separated. 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 on the bottom end side of the first support means, which is capable of supporting the first support means with respect to the container. The insert body is configured such that, in the containment state, the partition means and the first support means can float in the liquid to be separated, while the second support means cannot float in the liquid to be separated.

[0007] The separation insert according to claim 2 is the separation insert according to claim 1, By making the diameter of the partition means substantially the same as the inner diameter of the container, and by not providing any notches or openings other than the insert opening in the partition means, it is 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.

[0008] The separation insert according to claim 3 is Claim 1 In the separation insert described above, The separation insert comprises a second partition provided on the insert body, 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, and a second insert opening provided on the second partition, 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 centrifugal separation operation, and the second partition is provided on the opening end side of the second support means.

[0009] The separation insert according to claim 4 is Claim 1 In the separation insert described above, The second support means comprises a support body and a flange for holding the second support means in a predetermined position, with the flange provided at the bottom end of the support body.

[0010] The separation insert according to claim 5 is Claim 1 In the separation insert described above, The second support means comprises a substantially cylindrical support body and a flange portion provided over the entire end of the support body on the open end side, the flange portion for holding the second support means in a predetermined position, wherein the flange portion 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.

[0011] The separation insert according to claim 6 is Claim 1 In the separation insert described above, The insert body is a nozzle portion provided so as to protrude from the partition means toward the bottom end, and includes 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.

[0012] The separation insert according to claim 7 is Claim 6 In the separation insert described above, The inner diameter of the nozzle portion was made smaller towards the bottom end.

[0013] Claim 8 The separation device comprises a container having an open end with an opening and a bottom end provided opposite to the open end, and the separation insert according to claim 1 or 2.

[0014] The separation method according to claim 9 is 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 the container containing a liquid to be separated containing a sample, using a separation insert housed in the container, wherein the container has an open end having an opening and a bottom end provided opposite to the open end, and the separation insert has a partitioning means for partitioning the internal space of the container into a first internal space which is the space on the bottom end side and contains the first separation component after the centrifugal separation operation and a second internal space which is the space on the open end side and contains the second separation component after the centrifugal separation operation and a support means for supporting the partitioning means with respect to the container, and an insert opening provided in the partitioning means, during the centrifugal separation operation, the insert The insert body is configured such that, in a containment state in which the liquid to be separated is contained in the container, the partition means and the first support means are able to float on the liquid to be separated, and the second support means are not able to float on the liquid to be separated, and the insert body comprises 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, and 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 on the bottom end side of the first support means, and capable of supporting the first support means with respect to the container, and the insert body is configured such that, in a containment state in which the liquid to be separated is contained in the container, the partition means and the first support means are able to float on the liquid to be separated, and the second support means is not able to float on the liquid to be separated, and the separation method comprises a dispensing step of dispensing the liquid to be separated into the container, and after the dispensing step, performing the centrifugation operation on the container containing the liquid to be separated to separate the components of the sample into a first separation component and a second separation component. Centrifugal separation process The process includes, after the centrifugal separation step, a separation step of separating the second separated component, and Centrifugal separation processIn this case, during the centrifugation operation, at least a part of the insert main body portion floating on the separation target liquid in the accommodation state pushes up the first separation component toward the opening end side, thereby moving the first separation component from the second internal space to the first internal space via the insert opening.

Advantages of the Invention

[0016] According to the separation insert described in claim 1, or Claim 8 According to the separation instrument described in [reference], the insert main body portion is configured such that at least a part of the insert main body portion can float on the separation target liquid in the accommodation state. Therefore, in the accommodation state, at least a part of the insert main body portion floats on the separation target liquid, so that the first separation component and the second separation component can be effectively separated during the centrifugation operation regardless of the state of the sample. Thus, when decantation is performed after the centrifugation operation, it is possible to avoid the first separation component from being mixed into the second separation component, and it becomes possible to perform the separation with high purity. Furthermore, the insert body is configured such that, in the contained state, the partition means and the first support means can float on the liquid to be separated, while the second support means cannot float on the liquid to be separated. Therefore, in the contained state, the partition means and the first support means float on the liquid to be separated, allowing for effective separation of the first and second separation components during centrifugal separation, regardless of the state of the sample. In addition, when the liquid to be separated is not contained, the partition means and the first support means can be supported in the container via the second support means, improving the ease of installation of the insert body within the container.

[0017] According to the separation insert described in claim 2, By making the diameter of the partitioning means approximately the same as the inner diameter of the container, and by not providing any openings other than notches or insert openings in the partitioning means, it is possible to suppress the movement of air located in the first internal space from the first internal space to the second internal space when the container is filled. As a result, at least a portion of the insert body can be effectively floated in the liquid to be separated when the container is filled.

[0018] According to the separation insert described in claim 3, Since the second partition is provided on the open end side of the second support means, compared to the case where the second partition is provided on the bottom end side of the second support, it is easier to avoid the first separated component (especially the easily suspended component of the first separated component) mixing with the second separated component when decantation is performed after centrifugation, thus enabling separation with high purity.

[0019] According to the separation insert described in claim 4, Since the flange is provided at the bottom end of the support body, compared to the case where the flange is provided at the open end of the support body, it is possible to avoid the first separated component mixing with the second separated component when the first separated component is present in the gap between the support body and the side wall of the container, and to perform separation with high purity.

[0020] According to the separation insert described in claim 5, Since the flange is configured such that it protrudes from the end of the support body toward the open end and its outer surface is substantially flush with the inner surface of the container, compared to the case where the flange is provided at the bottom end of the support body, it is easier to avoid the first separated component (especially the easily suspended component of the first separated component) mixing with the second separated component when decantation is performed after centrifugation, thus enabling separation with higher purity.

[0021] According to the separation insert described in claim 6, The insert body is equipped with a nozzle portion that protrudes from the partitioning means toward the bottom end, so that the air located in the first internal space in the containment state can be prevented from moving from the first internal space to the second internal space, and at least a part of the insert body can be effectively floated in the liquid to be separated in the containment state.

[0022] According to the separation insert described in claim 7, By making the inner diameter of the nozzle smaller towards the bottom end, according to Newton's law of viscosity, the velocity of the liquid to be separated can be increased as it flows towards the bottom end within the nozzle. Therefore, compared to the case where the inner diameter of the nozzle is uniform, the first and second separation components can be effectively separated during the centrifugal separation operation, and the efficiency of the separation can be increased.

[0023] According to the separation method described in claim 9, Centrifugal separation processIn this configuration, during the centrifugation operation, at least a portion of the insert body, which floats in the liquid to be separated in the contained state, pushes the first separation component toward the opening end, thereby moving the first separation component from the second internal space to the first internal space via the insert opening. Therefore, because at least a portion of the insert body floats in the liquid to be separated in the contained state, the first separation component and the second separation component can be effectively separated during the centrifugation operation regardless of the state of the sample. Consequently, when decantation is performed after the centrifugation operation, contamination of the first separation component with the second separation component can be avoided, and preparative separation can be performed with high purity. Furthermore, the insert body is configured such that, in the contained state, the partition means and the first support means can float on the liquid to be separated, while the second support means cannot float on the liquid to be separated. Therefore, in the contained state, the partition means and the first support means float on the liquid to be separated, allowing for effective separation of the first and second separation components during centrifugal separation, regardless of the state of the sample. In addition, when the liquid to be separated is not contained, the partition means and the first support means can be supported in the container via the second support means, improving the ease of installation of the insert body within the container. [Brief explanation of the drawing]

[0025] [Figure 1] This is a front view showing an overview of the separation device according to Embodiment 1 of the present invention. [Figure 2] Figure 1 is a perspective view of the separation device from above. [Figure 3] Figure 1 is a perspective view of the separation device from below. [Figure 4] Figure 1 is a longitudinal cross-sectional view of the separation device. [Figure 5] This figure shows the state after excess air bubbles have been removed from the container during the dispensing step of the sample separation method. [Figure 6] This figure shows the state after the liquid to be separated has been injected during the dispensing step of the sample separation method. [Figure 7] This figure shows the state after the centrifugal separation step of the sample separation method has been performed. [Figure 8] This is a front view showing an overview of the separation device according to Embodiment 2. [Figure 9] Figure 8 is a perspective view of the separation device from above. [Figure 10] Figure 8 is a perspective view of the separation device from below. [Figure 11] Figure 8 is a longitudinal cross-sectional view of the separation device. [Figure 12] This is a magnified view showing the peripheral region of the separation insert in Figure 11. [Figure 13] This figure shows the results of the performance verification test, specifically the measurements taken using a blood cell counter on a cell suspension obtained by centrifugation using whole blood collected 48 hours prior to collection. [Figure 14] This figure shows the results of the performance verification test, specifically the measurements taken using a blood cell counter on a cell suspension obtained by centrifugation using whole blood collected 72 hours prior to blood collection. [Figure 15] This figure shows the results of the FCM analysis performed on a cell suspension obtained by centrifugation using whole blood collected 48 hours prior to blood collection, as described below, from the performance verification test results. [Figure 16] This figure shows the results of the FCM analysis performed on a cell suspension obtained by centrifugation using whole blood collected 72 hours prior to blood collection, as described later, from the performance verification test results. [Figure 17] This figure shows a modified example of the separation insert, and represents the region corresponding to Figure 4. [Figure 18] This figure shows a modified example of the separation insert, and represents the region corresponding to Figure 4. [Figure 19] This figure shows a modified example of the separation insert, and represents the region corresponding to Figure 4. [Figure 20] This figure shows a modified example of the separation insert, and represents the region corresponding to Figure 4. [Figure 21] This figure shows a modified example of the separation insert, and represents the region corresponding to Figure 4. [Modes for carrying out the invention]

[0026] The embodiments of the separation insert, separation device, and separation method according to this invention will be described in detail below with reference to the attached drawings. First, the basic concept of the embodiment will be described in [I], then the specific details of the embodiment will be described in [II], and finally, modifications of the embodiment will be described in [III]. However, the present invention is not limited by the embodiments.

[0027] [I] Basic Concepts of the Embodiments First, the basic concept of the embodiment will be explained. The embodiment is, in general terms, a separation insert housed in a container, which, when a centrifugal separation operation is performed on a container containing a liquid to be separated containing a sample, 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, via the separation insert, and relates to the separation apparatus and the separation method thereof.

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

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

[0030] Furthermore, the term "reagent" refers to any substance used to detect the target of analysis, and is a concept that includes, for example, magnetic particle reagents and latex particle reagents.

[0031] Furthermore, "sludge" refers to materials discharged, for example, as a result of water and sewage treatment or industrial wastewater treatment.

[0032] Furthermore, "separation target liquid" refers to the liquid used for separating the sample. This separation target liquid is a concept that includes, for example, a liquid containing only the sample, or a liquid containing the sample and the solution (for example, a specific gravity separation liquid and / or a diluent), but in this embodiment, it will be described as a liquid containing the sample and the solution.

[0033] [II] Specific details of the embodiment Next, the specific details of the embodiment will be described.

[0034] [Embodiment 1] First, let's describe the separation device according to Embodiment 1. This Embodiment 1 is a configuration in which the support part, which will be described later, comprises a first support part and a second support part, which will be described later.

[0035] (composition) First, the configuration of the separation device 1 according to Embodiment 1 will be described.

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

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

[0038] (Construction - Container) Returning to Figure 1, let's first explain the configuration of container 10.

[0039] The container 10 is for housing the sample and the separation insert 20. This container 10 is constructed, for example, using a known centrifuge tube, and comprises a container body 11, an opening 12, and a lid 13, as shown in Figure 1.

[0040] (Configuration - Container - Container body) The container body 11 is the basic structure of the container 10. This container body 11 is formed from a long, hollow body made of resin (or glass), and specifically, the bottom portion 11d of the container body 11 is formed from a hollow body that is roughly conical in shape.

[0041] Furthermore, as shown in Figure 1, the container body 11 has an open end 11a on which the opening 12 is provided, a bottom end 11b provided opposite to the open end 11a, and a side wall portion 11c provided between the open end 11a and the bottom end 11b.

[0042] In the first embodiment, the "bottom portion 11d" refers to the portion of the container body 11 that includes the bottom end 11b and its vicinity, as shown in Figure 1.

[0043] Furthermore, while the specific shape and size of the container body 11 are arbitrary, in Embodiment 1 they are set as follows.

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

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

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

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

[0048] The specific shape and size of this opening 12 are arbitrary, but in Embodiment 1 they are set as follows.

[0049] In other words, the shape of the opening 12 is set to be approximately circular. However, it is not limited to this, and may be set to, for example, an approximately elliptical shape or an approximately polygonal shape (for example, an approximately rectangular shape).

[0050] Furthermore, the diameter of the opening 12 is set to be approximately the same as the outer diameter of the opening end 11a. However, this is not the only option; for example, it may be set to be smaller than the outer diameter of the opening end 11a.

[0051] (Composition - Container - Lid) The lid portion 13 is for sealing the opening 12. This lid portion 13 is formed of a hollow resin body with an open bottom surface, and as shown in Figure 1, when the opening 12 is sealed by the lid portion 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 locking structure).

[0052] Furthermore, while the specific shape and size of the lid portion 13 are arbitrary, in Embodiment 1 they are set as follows.

[0053] In other words, the cross-sectional shape of the lid portion 13 along the XY plane is set to a shape that can be fitted to the open end portion 11a of the container body 11 and the portion near it, and as an example, it is set to be approximately annular.

[0054] Furthermore, the inner diameter of the lid portion 13 is set to a size that allows it to be fitted to the open end portion 11a of the container body 11 and the surrounding portion. Specifically, it is set to be approximately the same as the outer diameter of the open end portion 11a of the container body 11.

[0055] Furthermore, the vertical length of the lid portion 13 is set to a length that allows it to be fitted to the open end portion 11a of the container body 11 and the surrounding portion. For example, it is set to a length of about one-eighth to one-sixth of the vertical length of the container body 11.

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

[0057] The separation insert 20 is used to separate the components of the sample into the first separation component S1 and the second separation component S2 shown in Figure 7 when a centrifugation operation is performed on the container 10 containing the liquid LS to be separated, which contains the sample. The separation insert 20 is formed separately from the container 10 and is housed 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 arrangement; for example, a part of the container body 11 may be positioned at the bottom portion 11d).

[0059] Furthermore, as shown in Figures 1 to 4, the separation insert 20 comprises an insert body 30, a first insert opening 80, and a second insert opening 90.

[0060] (Configuration - Separation insert - Insert body) The insert body portion 30 is the basic structure of the separation insert 20 and, as shown in Figure 4, comprises a first partition portion 40, a second partition portion 50, a support portion 60, and a nozzle portion 70.

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

[0062] Furthermore, "first separated component S1" refers to the component to be removed from the sample components separated by the centrifugation operation, and in Embodiment 1, this corresponds to a predetermined cell contained in the blood (for example, red blood cells).

[0063] Furthermore, "second separation component S2" refers to components of the sample separated by centrifugation other than the first separation component S1, and in Embodiment 1, this includes components that are to be separated (for example, white blood cells).

[0064] (Configuration - Separation 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. This first partition 40 is formed of a roughly plate-shaped body made of resin (or glass), and specifically, as shown in Figure 4, it is formed as a roughly plate-shaped body with a concave shape that is recessed downwards.

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

[0066] Here, "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, where the first separated component S1 is contained after the centrifugal separation operation.

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

[0068] Furthermore, "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, where the second separated component S2 is contained after the centrifugal separation 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, from the first partition 40 to the open end 11a of the container body 11, when the container is filled.

[0070] (Configuration - Separation insert - Insert body - Second partition) The second partition 50 is for dividing the first internal space IS1 into a bottom-side first internal space IS1a and an opening-side first internal space IS1b. This second partition 50 is formed of a roughly plate-shaped body made of resin (or glass), and specifically, as shown in Figure 4, it is formed as a roughly plate-shaped body with a concave shape that is recessed downwards.

[0071] Furthermore, as shown in Figure 4, the second partition 50 is located above the bottom portion 11d of the container body 11 and below the first partition 40 when the container is filled.

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

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

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

[0075] In Embodiment 1, as shown in Figure 1, this opening-side first internal space IS1b corresponds to the space from the first partition 40 to the second partition 50 within the first internal space IS1 when the container is filled.

[0076] (Configuration - Separation insert - Insert body - Support part) The support portion 60 is a support means for supporting the first partition portion 40 with respect to the container 10, and as shown in Figure 1, it comprises a first support portion 61 and a second support portion 62.

[0077] (Configuration - Separation insert - Insert body - Support part - First support part) The first support portion 61 is part of the basic structure of the support portion 60. This first support portion 61 is formed as a roughly cylindrical body made of resin (or glass) with an open top and bottom surface, and as shown in Figure 4, it is provided to protrude from the first partition portion 40 toward the bottom end 11b side of the container body 11 (downward side in Figure 4) and is connected to the first partition portion 40.

[0078] (Configuration - Separation insert - Insert body - Support part - Second support part) The second support portion 62 is another part of the basic structure of the support portion 60, and enables the first support portion 61 to be supported by the container 10. This second support portion 62 is formed separately from the first support portion 61 and, as shown in Figure 4, is provided on the bottom end 11b side of the container body 11 than the first support portion 61.

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

[0080] (Configuration - Separation insert - Insert body - Support part - Second support part - Support body part) The support body 63 is the basic structure of the second support body 62. This support body 63 is formed as a roughly cylindrical body made of resin (or glass) with an open top and bottom surface, and as shown in Figure 4, it is provided to protrude from the second partition 50 toward the open end 11a side of the container body 11 (upper side in Figure 4) and is connected to the second partition 50.

[0081] (Structure - Separation insert - Insert body - Support part - Second support part - Flange part) The flange portion 64 is for holding the second support portion 62 in a predetermined position. This flange portion 64 is formed as a roughly annular body made of resin (or glass), and as shown in Figure 4, it is provided to protrude outward from the support body portion 63 toward the outside of the container 10 and is connected to the support body portion 63.

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

[0083] With this installation, compared to the case where the flange portion 64 is 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 in Figure 4), if the first separated component S1 is present in the gap between the support body portion 63 and the side wall portion 11c of the container 10, it is possible to avoid the first separated component S1 mixing with the second separated component S2, and to perform separation with high purity.

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

[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 flowing 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 flowing in the opposite direction to the above one direction), and the liquid to be separated LS flowing from the first internal space IS1 to the second internal space IS2 and simultaneously from the second internal space IS2 to the first internal space IS1 (i.e., the liquid to be separated LS flowing simultaneously in both the above one direction and the above reverse direction).

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

[0087] Specifically, the nozzle portion 70 is positioned such that its upper end is in direct communication with the first insert opening 80, which will be described later, and is connected to the first partition portion 40.

[0088] This nozzle portion 70 prevents the air located in the first internal space IS1 from moving from the first internal space IS1 to the second internal space IS2 in the containment state described later, and allows at least a portion of the insert body portion 30 to be effectively suspended in the liquid LS to be separated in the containment state described later.

[0089] (Configuration - Separation insert - Insert body - Other components) Furthermore, while the specific configuration of the insert body 30 is arbitrary, in Embodiment 1 it is configured as follows.

[0090] (Configuration - Separation Insert - Insert Body - Other Components - Configuration 1) First, in the state in which the liquid to be separated LS is contained in the container 10 (hereinafter referred to as the "contained state"), the insert body 30 is configured such that at least a part of the insert body 30 can float on the liquid to be separated LS.

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

[0092] For more details, 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] (Regarding the configuration - separation insert - insert body - other components - first partition section) Specifically, the planar shape of the first partition 40 is set to be approximately the same as the inner diameter shape of the part of the container body 11 other than the bottom part 11d, and more precisely, it is set to be approximately circular.

[0094] Furthermore, the diameter of the first partition 40 is set to be smaller than the inner diameter of the parts 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 LS to be separated, and also to a length that ensures the desired strength of the first partition 40. For example, it may be set to approximately 0.3 mm to 1.0 mm.

[0096] (Regarding the configuration - separation insert - insert body - other components - second partition section) Furthermore, the planar shape of the second partition 50 is set to be approximately the same as the inner diameter shape of the part of the container body 11 other than the bottom part 11d, and specifically, it is set to be approximately circular.

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

[0098] Furthermore, the thickness of the second partition 50 is set to a length that ensures the desired strength of the second partition 50, and as an example, it may be set to approximately 0.3 mm to 1.0 mm.

[0099] (Regarding the configuration - separate insert - insert body - other components - first support part) Furthermore, the planar shape of the first support portion 61 is set to be approximately annular. However, it is not limited to this, and may be set to annular shapes other than approximately annular (for example, rectangular annular or triangular annular shapes).

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

[0101] Furthermore, the vertical length of the first support portion 61 is set so that the lower end of the first support portion 61 is located above the second partition portion 50. For example, it is set to be about 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 LS to be separated, and also to a length that ensures the desired strength of the first support portion 61. For example, it may be set to approximately 0.3 mm to 1.0 mm.

[0103] (Regarding the configuration - separate insert - insert body - other components - second support part) Furthermore, the planar shape of the support body portion 63 of the second support portion 62 is set to be approximately circular. However, it is not limited to this, and may be set to a circular shape other than approximately circular (for example, a rectangular circular shape or a triangular circular shape).

[0104] Furthermore, the outer diameter of the support body portion 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 portion 63 of the second support portion 62 is set to be approximately the same as the vertical length of the first support portion 61. However, this is not limited to this, and for example, it may be set to be different from the vertical length of the first support portion 61.

[0106] Furthermore, the thickness of the support body portion 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 as an example, it may be set to about 0.3 mm to 1.0 mm.

[0107] Furthermore, the outer diameter of the flange portion 64 of the second support portion 62 is set to a length that allows the second support portion 62 to be held in place by the container 10, and more specifically, it is set to be approximately the same as the inner diameter of the container 10.

[0108] Furthermore, the inner diameter of the flange portion 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 portion 64 of the second support portion 62 is set to a length that can ensure the desired strength of the flange portion 64 of the second support portion 62, and as an example, it may be set to about 0.3 mm to 1.0 mm.

[0110] (Regarding the components - separation insert - insert body - other components - nozzle part) Furthermore, the inner diameter of the nozzle portion 70 is set to decrease as it approaches the bottom end 11b side of the container body 11 (the lower side in Figure 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 later, 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 later.

[0112] As a result, according to Newton's law of viscosity, the speed of the liquid to be separated LS flowing through the nozzle section 70 can be increased as it flows toward the bottom end 11b of the container body 11. Therefore, compared to the case where the inner diameter of the nozzle section 70 is uniform, the first separation component S1 and the second separation component S2 can be effectively separated in the centrifugal separation operation, and the efficiency of the separation can be increased.

[0113] However, this is not the only option; for example, the inner diameter of the nozzle portion 70 may be set to be uniform.

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

[0115] However, the configuration is not limited to this; for example, the length may be set such that the lower end of the nozzle portion 70 is located below (or above) the lower end of the first support portion 61.

[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 on the liquid LS to be separated, and to a length that ensures the desired strength of the nozzle portion 70. For example, it may be set to about 0.3 mm to 1.0 mm.

[0117] With this configuration, when the liquid to be separated LS is contained, the first partition 40 and the first support 61 float on the liquid to be separated LS, so that the first separation component S1 and the second separation component S2 can be effectively separated during the centrifugation operation regardless of the state of the sample (in particular, when the liquid to be separated LS is contained, the red blood cells of the first separation component S1 whose specific gravity has changed can be pushed upward toward the open end 11a of the container body 11 by the floating first partition 40 and the first support 61, thereby moving them to the opening side first internal space IS1b and / or the bottom side first internal space IS1a via the first insert opening 80, which contributes to improving the separation efficiency). Furthermore, when the liquid to be separated LS is not contained, the first partition 40 and the first support 61 can be supported in the container 10 via the second support 62, which improves the ease of installation of the insert body 30 within the container 10.

[0118] (Configuration - Separation Insert - Insert Body - Other Configurations - Configuration 2) Furthermore, the first partition portion 40, the first support portion 61, and the nozzle portion 70 are integrally formed, and the second partition portion 50 and the second support portion 62 (support body portion 63 and flange portion 64) are integrally formed.

[0119] Specifically, each part is formed as a single unit by injection molding (or 3D printing) of a transparent resin material.

[0120] This allows the separation insert 20 to be constructed simply and quickly, improving the manufacturability of the separation insert 20.

[0121] However, this is not limited to this, and for example, the first partition 40, the first support 61, the nozzle 70, the second partition 50, and the second support 62 may each be formed separately, and then the first partition 40, the first support 61, and the nozzle 70 may be connected by fasteners, etc., while the second partition 50 and the second support 62 may also be connected by fasteners, etc.

[0122] (Configuration - Separation insert - First insert opening) Returning to Figure 2, the first insert opening 80 is an insert opening that 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 first insert opening 80 during the centrifugal separation operation. At least one of these first insert openings 80 is provided in the first partition 40, specifically, as shown in Figure 2, only one is provided in the approximately central part of the first partition 40 (however, it is not limited to this, and for example, multiple openings may be provided).

[0123] Furthermore, while the specific shape and size of the first insert opening 80 are arbitrary, in Embodiment 1 they are set as follows.

[0124] In other words, the shape of the first insert opening 80 is set to be approximately circular. However, it is not limited to this, and may be set to be approximately elliptical, approximately polygonal (for example, approximately rectangular).

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

[0126] (Configuration - Separation insert - Second insert opening) The second insert opening 90 is an opening that 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 during the centrifugal separation operation. At least one of these second insert openings 90 is provided in the second partition 50, specifically, as shown in Figure 3, only one is provided in the approximate central part of the second partition 50 (however, it is not limited to this, and for example, multiple openings may be provided).

[0127] Furthermore, while the specific shape and size of the second insert opening 90 are arbitrary, in Embodiment 1 they are set as follows.

[0128] In other words, the shape of the second insert opening 90 is set to be approximately circular. However, it is not limited to this, and may be set to be approximately elliptical, approximately polygonal (for example, approximately rectangular).

[0129] Furthermore, 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 limited to this, and for example, it may be set to be different from the diameter of the first insert opening 80.

[0130] With the separation insert 20 and separation apparatus 1 described above, at least a portion of the insert body 30 floats in the liquid LS to be separated when contained, so that the first separation component S1 and the second separation component S2 can be effectively separated during the centrifugation operation regardless of the state of the sample. Therefore, when decantation is performed after the centrifugation operation, the mixing of the first separation component S1 with the second separation component S2 can be avoided, and separation can be performed with high purity.

[0131] (Method for separating samples) Next, a method for separating a sample using the separation device 1 according to Embodiment 1 will be described.

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

[0133] (Method for separating samples - Dispensing process) First, let's explain the dispensing process.

[0134] The dispensing process involves dispensing the liquid to be separated, LS, into container 10.

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

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

[0137] Next, the separation device 1 is placed in a centrifuge (not shown), and then the container 10 is used to remove excess air bubbles from inside the container 10.

[0138] Furthermore, as shown in Figure 5, when the excess air bubbles are removed, the state inside the container 10 is such that the first partition 40, the first support 61, and the nozzle 70 are floating in the specific gravity separation liquid LS1, while the second partition 50 and the second support 62 are held in place by the container 10.

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

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

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

[0142] Here, the method for setting the amount of sample solution LS2 poured into container 10 is arbitrary, but in Embodiment 1, it is set to an amount such that, after the centrifugation step, the interface of the first separated component S1 is at approximately the same position as (or lower than) the first partition 40.

[0143] (Method for separating samples - Centrifugal separation step) Next, we will explain the centrifugal separation process.

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

[0145] Specifically, first, the separation device 1 is set in a centrifuge, and then the centrifuge is used to perform a centrifugation process for a predetermined time, thereby performing a centrifugation operation on the container 10. After that, the first partition 40, the first support 61, and the nozzle 70 floating in the liquid LS to be separated are pushed down to the second support 62 using a dispenser.

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

[0147] During the centrifugal separation operation described above, the first partition 40, the first support 61, and the nozzle 70 float in the liquid LS to be separated. The first partition 40 and the first support 61, which are suspended, push the red blood cells, whose specific gravity has changed, towards the open end 11a of the container body 11. This allows them to move through the first insert opening 80 to the first internal space IS1b on the open side and / or the first internal space IS1a on the bottom side, thereby improving the separation efficiency.

[0148] Furthermore, since the inner diameter of the nozzle portion 70 decreases towards the bottom end 11b side of the container body 11, the first separation component S1 and the second separation component S2 can be effectively separated during the centrifugal separation operation, thereby increasing the efficiency of the separation.

[0149] (Method for separating samples - preparative process) Next, I will explain the preparation process.

[0150] The preparative step is a step in which the second separated component S2 is separated after the centrifugation step.

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

[0152] The separated second component S2 is then subjected to a predetermined measurement or analysis process using a known measuring or analytical device (not shown) after, for example, a known liquid culture medium or the like has been added to another container.

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

[0154] (Effects of Embodiment 1) As described above, according to Embodiment 1, the insert body 30 is configured such that at least a portion of it can float in the liquid LS to be separated when it is contained. Therefore, when the insert body 30 is contained, at least a portion of it floats in the liquid LS to be separated, allowing for effective separation of the first separation component S1 and the second separation component S2 during centrifugation, regardless of the state of the sample. Thus, when decantation is performed after centrifugation, the first separation component S1 cannot be mixed with the second separation component S2, and separation can be performed with high purity.

[0155] Furthermore, the insert body 30 is configured such that, in the containment state, the first partition 40 and the first support 61 can float in the liquid to be separated LS, while the second support 62 cannot float in the liquid to be separated LS. Therefore, in the containment state, the first partition 40 and the first support 61 float in the liquid to be separated LS, allowing for effective separation of the first separation component S1 and the second separation component S2 during the centrifugation operation, regardless of the state of the sample. In addition, when the liquid to be separated LS is not contained, the first partition 40 and the first support 61 can be supported in the container 10 via the second support 62, improving the ease of installation of the insert body 30 within the container 10.

[0156] Furthermore, since the flange portion 64 is provided at the bottom end 11b side of the support body portion 63, compared to the case where the flange portion 64 is provided at the open end 11a side of the support body portion 63, it is possible to avoid the first separated component S1 being mixed into the second separated component S2 when the first separated component S1 is present in the gap between the support body portion 63 and the side wall portion 11c of the container 10, and separation can be performed with high purity.

[0157] Furthermore, since the insert body portion 30 is equipped with a nozzle portion 70 that protrudes from the first partition portion 40 toward the bottom end portion 11b, it is possible to suppress the movement of air located in the first internal space IS1 to the second internal space IS2 when the insert is contained, and at least a part of the insert body portion 30 can be effectively suspended in the liquid LS to be separated when the insert is contained.

[0158] Furthermore, since the inner diameter of the nozzle portion 70 is made smaller towards the bottom end 11b, according to Newton's law of viscosity, the velocity of the liquid to be separated LS flowing through the nozzle portion 70 can be increased as it flows towards the bottom end 11b. Therefore, compared to the case where the inner diameter of the nozzle portion 70 is uniform, the first separation component S1 and the second separation component S2 can be effectively separated in the centrifugal separation operation, and the efficiency of the separation can be increased.

[0159] Furthermore, in the separation step of the separation method, during the centrifugation operation, the first separation component S1 is pushed upward toward the opening end 11a by at least a portion of the insert body 30, which is floating in the liquid LS to be separated in the containment state, thereby moving the first separation component S1 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 LS to be separated in the containment state, the first separation component S1 and the second separation component S2 can be effectively separated during the centrifugation operation regardless of the state of the sample. Thus, when decantation is performed after the centrifugation operation, contamination of the first separation component S1 with the second separation component S2 can be avoided, and separation can be performed with high purity.

[0160] [Embodiment 2] First, the separation device according to Embodiment 2 will be described. This Embodiment 2 is a configuration in which the second partition is provided on the open end side of the second support. However, unless otherwise specified, the configuration of this Embodiment 2 is substantially the same as the configuration of Embodiment 1, and for components that are substantially the same as the configuration of Embodiment 1, the same reference numerals and / or names used in this Embodiment 1 will be used as necessary, and their descriptions will be omitted.

[0161] (composition) First, the configuration of the separation device 1 according to Embodiment 2 will be described.

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

[0163] (Construction - Container) First, let's explain the configuration of container 10.

[0164] The container 10 according to Embodiment 2 is configured in substantially the same way as the container 10 according to Embodiment 1.

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

[0166] The separation insert 20 according to Embodiment 2 is configured in substantially the same way as the separation insert 20 according to Embodiment 1, as shown in Figures 8 to 12. However, the details of the configuration of the insert body 30 are improved as described below.

[0167] (Configuration - Separation insert - Insert body) Returning to Figure 8, the insert body 30 includes a first partition 40, a second partition 50, a support 60, and a nozzle 70, as shown in Figures 8 to 12.

[0168] (Configuration - Separation insert - Insert body - First partition) Returning to Figure 8, as shown in Figure 8, the first partition 40 is positioned above the bottom portion 11d of the container body 11 when the container is filled.

[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 by not providing any notches or openings other than the first insert opening 80 in the first partition 40, it is possible to suppress the movement of air located in the first internal space IS1 to the second internal space IS2 when the container is filled.

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

[0171] Furthermore, as shown in Figures 9 and 11, the first partition 40 is provided only with the first insert opening 80.

[0172] This configuration of the first partition 40 makes it possible to suppress the movement of air located in the first internal space IS1 to the second internal space IS2 in the containment state, and to effectively suspend at least a portion of the insert body 30 in the liquid LS to be separated in the containment state.

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

[0174] Furthermore, while the specific configuration of the second partition 50 is arbitrary, in Embodiment 2, the second partition 50 is provided on the open end 11a side (upper side in Figure 12) of the second support 62, which will be described later.

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

[0176] However, this is not limited to this, and for example, the second partition 50 may be located on the bottom end 11b side (the lower side in Figure 12) of the second support portion 62 described later, rather than on the open end 11a side, and also on the open end 11a side of the central part in the vertical direction of the second support portion 62 described later.

[0177] With this configuration of the second partition 50, compared to the case where the second partition 50 is provided on the bottom end 11b side of the second support 62 described later, it is easier to avoid the first separated component S1 (especially the components of the first separated component S1 that tend to float) mixing with the second separated component S2 when decantation is performed after centrifugation, thus enabling separation with high purity.

[0178] (Configuration - Separation insert - Insert body - Support part) Returning to Figure 8, the support portion 60 includes a first support portion 61 and a second support portion 62, as shown in Figures 8 to 12.

[0179] (Configuration - Separation insert - Insert body - Support part - First support part) The first support portion 61 according to Embodiment 2 is configured in substantially the same manner as the first support portion 61 according to Embodiment 1.

[0180] (Configuration - Separation insert - Insert body - Support part - Second support part) The second support portion 62 is formed separately from the first support portion 61 and, as shown in Figures 11 and 12, is located on the bottom end 11b side of the container body 11 than the first support portion 61, and includes a support body portion 63 and a flange portion 64.

[0181] (Configuration - Separation insert - Insert body - Support part - Second support part - Support body part) The support body 63 according to Embodiment 2 is configured in substantially the same way as the support body 63 according to Embodiment 1.

[0182] (Structure - Separation insert - Insert body - Support part - Second support part - Flange part) Returning to Figure 8, the flange portion 64 is provided across the entire end of the support body portion 63 on the open end 11a side (upper end in Figure 8), as shown from Figure 8 to Figure 12.

[0183] Furthermore, although the specific configuration of the flange portion 64 is arbitrary, in Embodiment 2, the flange portion 64 is configured such that it protrudes from the end of the support body portion 63 on the open end 11a side toward the open end 11a side, and the outer surface of the flange portion 64 substantially conforms to the inner surface of the container 10.

[0184] Specifically, the cross-sectional shape of the flange portion 64 along the XZ plane is set to be a roughly convex shape that protrudes upward, as shown in Figure 12.

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

[0186] Furthermore, the inner diameter of the flange portion 64 is set to be smaller than the outer diameter of the flange portion 64 and to increase as it approaches the top. However, this is not the only option; for example, the inner diameter of the flange portion 64 may be set to be uniform across almost the entire surface.

[0187] With this flange portion 64, compared to the case where the flange portion 64 is provided at the bottom end 11b side of the support body portion 63, it is easier to avoid the first separated component S1 (especially the easily suspended components of the first separated component S1) mixing with the second separated component S2 when decantation is performed after centrifugation, thus enabling separation with high purity.

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

[0189] (Configuration - Separation insert - Insert body - Nozzle part) The nozzle portion 70 according to Embodiment 2 is configured in substantially the same way as the nozzle portion 70 according to Embodiment 1.

[0190] With the separation insert 20 and separation apparatus 1 described above, similar to the separation insert 20 and separation apparatus 1 in Embodiment 1, at least a portion of the insert body 30 floats in the liquid LS to be separated when it is contained, so that the first separation component S1 and the second separation component S2 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 avoid the first separation component S1 mixing with the second separation component S2, and to perform separation with high purity.

[0191] (Method for separating samples) Next, the method for separating the sample using the separation apparatus 1 according to Embodiment 2 is the same as the separation method according to Embodiment 1, so its explanation will be omitted.

[0192] (Examples of implementation) The following describes specific examples of implementations using the separation insert of the present invention (specifically, examples of performance verification tests). However, the present invention is not limited to the contents of the following examples.

[0193] (Implementation Examples - Overview of the Test) First, I will explain the overview of the performance verification test.

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

[0195] (Examples of implementation - Overview of the test - Details of the configuration of various isolation inserts) Furthermore, the various separation inserts used in performance verification tests are classified into two types (hereinafter referred to as "fixed cell separation inserts" and "floating cell separation inserts").

[0196] Of these, the fixed cell isolation insert used was the same as the isolation insert described in the aforementioned International Publication No. 2012 / 149641.

[0197] Furthermore, the suspension-type cell isolation insert used was the same as the one used for the isolation insert 10 according to Embodiment 2.

[0198] (Implementation Examples - Examination Overview - Examination Methods) The test method for this performance verification test is optional, but it is as follows:

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

[0200] Furthermore, for the sample solution LS2 described later, performance verification tests were conducted for each of the three sample solutions, each containing a sample solution containing three different whole blood samples (hereinafter referred to as "Sample 1," "Sample 2," and "Sample 3") collected from different donors.

[0201] For details of the performance verification test described above, first, 15 mL of specific gravity separation solution LS1 was dispensed into a first container (identical to container 10 above) containing a fixed cell separation insert and a second container (identical to container 10 above) containing a suspension cell separation insert.

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

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

[0205] Next, in each of the first and second containers, the supernatant containing the cells to be recovered, which was contained in the upper part of the first separation insert (or second separation insert), was decanted into another container, and then a cell count was performed on the supernatant using a hemocytometer (a hemocytometer manufactured by HORIBA).

[0206] The supernatants collected from the first and second containers were centrifuged, and 100 μL of the first liquid (PBS (phosphate-buffered saline)) was added to each pellet (the precipitate after centrifugation (specifically, the separated human peripheral blood mononuclear cells (PBMCs))) in the FCM (flow cytometer) tube to suspend them.

[0207] Next, 5 μL of a reagent (Human TruStain FcX from BioLegend) to prevent antibody binding was added to each FCM tube, and the FCM tubes were left to stand at room temperature for 10 minutes.

[0208] Next, after adding the first liquid described above, the mixture was centrifuged using a centrifuge under predetermined conditions (500 × g, 5 minutes, room temperature).

[0209] Next, after removing the supernatant, 20 μL of antibody solution (Multicolor TBNK antibody solution from BD Biosciences) was added to each sample and mixed by vortex mixing. The samples were 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, and then the mixture was centrifuged under specified 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, and the cell saturates separated using each isolation insert were obtained.

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

[0213] (Case Study - Detailed Results of Performance Verification Tests) Next, we will explain the details of the performance verification test results.

[0214] The following results were confirmed from the performance verification tests.

[0215] First, regarding the measurement results from the blood cell analyzer shown in Figures 13 and 14, regardless of the type of sample (specifically, the first, second, and third samples) and the time elapsed since blood collection, the ratio of lymphocytes to white blood cells in the supernatant contained in the second container was higher than the ratio of lymphocytes to white blood cells in the supernatant contained in the first container. Furthermore, regardless of the type of sample, the ratio of granulocytes to white blood cells in the supernatant contained in the second container was lower than the ratio of granulocytes to white blood cells in the supernatant contained in the first container.

[0216] First, regarding the analysis results from FCM analysis shown in Figures 15 and 16, regardless of the type of sample (specifically, the first, second, and third samples) and the time elapsed since blood collection, the ratio of various target components (specifically, CD3, CD4, CD8, CD19, and CD16 / 56 positive cells) to lymphocytes separated by suspension-type cell separation inserts was higher than the ratio of various target components (specifically, CD3, CD4, CD8, CD19, and CD16 / 56 positive cells) to lymphocytes separated by fixed-type cell separation inserts.

[0217] CD3 is a component of the T cell receptor and a unique marker common to T cells. CD4 is a transmembrane glycoprotein and is 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 marker for glycoproteins involved in the development, activation, differentiation, and antibody production of B cells. CD16 is a marker present on quiescent NK cells. CD56 is a marker whose expression is elevated on activated NK cells.

[0218] These test results (specifically, the analysis results from FCM analysis shown in Figures 15 and 16) confirm the effectiveness of using the separation insert 10 of the present invention, as it allows for the effective separation of target components by using a suspension-type cell separation insert.

[0219] (Effects of Embodiment 2) As described above, according to Embodiment 2, by making the diameter of the first partition portion 40 substantially the same as the inner diameter of the container 10, and by not providing any notches or openings other than the first insert opening 80 in the first partition portion 40, it is possible to suppress the movement of air located in the first internal space IS1 to the second internal space IS2 in the containment state. Thus, it is possible to suppress the movement of air located in the first internal space IS1 to the second internal space IS2 in the containment state, and at least a part of the insert body portion 30 can be effectively floated in the liquid LS to be separated in the containment state.

[0220] Furthermore, since the second partition 50 is provided on the open end 11a side of the second support 62, compared to the case where the second partition 50 is provided on the bottom end 11b side of the second support 62, it is easier to avoid the first separated component S1 (especially the components of the first separated component S1 that tend to float) mixing with the second separated component S2 when decantation is performed after centrifugation, thus enabling separation with high purity.

[0221] Furthermore, since the flange portion 64 is configured such that it protrudes from the end of the support body portion 63 on the open end 11a side toward the open end 11a side, and the outer surface of the flange portion 64 substantially conforms to the inner surface of the container 10, compared to the case where the flange portion 64 is provided at the end of the support body portion 63 on the bottom end 11b side, it is easier to avoid the first separated component S1 (especially the components of the first separated component S1 that tend to float) mixing with the second separated component S2 when decantation is performed after centrifugation, thereby enabling separation with high purity.

[0222] [III] Modifications of the Embodiments While embodiments of the present invention have been described above, the specific configurations and means of the present invention can be arbitrarily modified and improved within the scope of the technical idea of ​​each invention described in the claims. Such modifications will be described below.

[0223] (Regarding the problems to be solved and the effects of the invention) First, the problems that the invention aims to solve and the effects of the invention are not limited to those described above. The present invention may solve problems not described above, produce effects not described above, solve only some of the problems described above, or produce only some of the effects described above.

[0224] (Regarding shape, numerical values, structure, and time series) With regard to the components illustrated in the embodiments and drawings, their shapes, numerical values, or the interrelationships of the structure or time series of multiple components can be arbitrarily modified and improved within the scope of the technical concept of the present invention.

[0225] (Regarding the separation device) In embodiments 1 and 2 described above, the container 10 and the separation insert 20 are formed separately, but the invention is not limited to this, and for example, the container 10 and the separation insert 20 may be formed as a single unit.

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

[0227] (Regarding the container) In the embodiments 1 and 2 described above, the bottom portion 11d of the container body 11 is formed as a hollow body that is substantially conical in shape. However, the invention is not limited to this, and for example, the bottom portion 11d of the container body 11 may be formed as a hollow body that is substantially hemispherical in shape.

[0228] (Regarding the separate insert) In the embodiments 1 and 2 described above, the separation insert 20 is provided with a second partition portion 50 and a second insert opening 90. However, the invention is not limited to this, and for example, the second partition portion 50 and the second insert opening 90 may be omitted.

[0229] (Regarding the first and second partition sections) In the embodiments 1 and 2 described above, the first partition portion 40 and the second partition portion 50 are formed as a concave, substantially plate-like body that is recessed downwards. However, the invention is not limited to this, and for example, they may be formed as a substantially flat, substantially plate-like body.

[0230] (Regarding the support structure) In the above 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-quarter of 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 portion 60 may be set to be shorter than the vertical length of the support portion 60 according to Embodiment 1 (for example, about half the vertical length of the support portion 60).

[0232] In this case, for example, as shown in Figure 17, the nozzle portion 70 may be provided such that its upper end is in direct communication with the first insert opening 80, and its lower end is also in direct communication with the first insert opening 80.

[0233] Furthermore, as shown in Figure 18, the nozzle portion 70 may be provided such that its vertical length is shorter than that of the nozzle portion 70 in Figure 17, so that the upper end of the nozzle portion 70 is in direct communication with the first insert opening 80, but the lower end of the nozzle portion 70 is not in direct communication with 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 Embodiment 1.

[0235] Furthermore, although the first embodiment described above states that the support portion 60 comprises a first support portion 61 and a second support portion 62, it is not limited to this. For example, the support portion 60 may have a first support portion 61 with the same configuration or a first support portion 61 with a different configuration instead of the second support portion 62.

[0236] As an example, the support portion 60 may include the first support portion 61 shown in Figure 17 and the first support portion 61 shown in Figure 18.

[0237] Furthermore, although the first embodiment described above states that the support body portion 63 of the second support portion 62 is formed as a substantially cylindrical body, it is not limited to this. For example, the support body portion 63 may include a plurality of legs that protrude from the lower end of the first support portion 61 toward the bottom end 11b of the container body 11 and are spaced apart from each other, and an annular connecting portion that connects the plurality of legs.

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

[0239] (Regarding the nozzle) In the above embodiment 1, the nozzle portion 70 is provided in the first partition portion 40, but this is not limited to this, and for example, as shown in Figures 19 and 20, the nozzle portion 70 may be omitted.

[0240] In this case, for example, as shown in Figure 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 in Figure 19).

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

[0242] (Regarding the guard) In the above embodiment 1, the flange portion 64 was described as being provided at the end of the support body portion 63 on the bottom end 11b side of the container body 11. However, it is not limited to this, and for example, as shown in Figure 21, it may be provided at the end of the support body portion 63 on the open end 11a side of the container body 11 (the upper end in Figure 21).

[0243] (Note) The separation insert in Appendix 1 is a separation insert housed in a container, and when a centrifugal separation operation is performed on the container containing the liquid to be separated, which contains the sample, 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, wherein the container has an open end with an opening and a bottom end provided opposite to the open end, and the separation insert comprises a first internal space which is the space on the bottom end side, which contains the first separation component after the centrifugal separation operation, and a second internal space which is the space on the open end side. The insert body comprises a partitioning means for separating the container from a second internal space in which the second separated component is contained after the centrifugal separation operation, and a support means for supporting the partitioning means with respect 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 centrifugal separation operation, and the insert body is configured such that at least a part of the insert body can float on the liquid to be separated when the container is filled with the liquid to be separated.

[0244] The separation insert of Appendix 2 is the separation insert of 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 on the bottom end side of the first support means, and capable of supporting the first support means with respect to the container, and the insert body is configured such that, in the contained 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 in Appendix 3, in the separation insert described in Appendix 2, has a diameter of the partition means that is approximately 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.

[0246] The separation insert of Appendix 4 is the separation insert of Appendix 2, wherein the separation insert comprises a second partition portion provided on the insert body portion, which partitions 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 on 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 centrifugal separation operation, and the second partition portion is provided on the opening end side portion of the second support means.

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

[0248] The separation insert of Appendix 6, in the separation insert of Appendix 2, comprises a substantially cylindrical support body and a flange portion provided over the entire end of the support body on the open end side, for holding the second support means in a predetermined position, wherein the flange portion 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 is substantially aligned with the inner surface of the container.

[0249] The separation insert of Supplementary Note 7 is the separation insert described in Supplementary Note 1 or 2, wherein the insert main body portion is a nozzle portion provided so as to project from the partitioning means toward the bottom end portion side, and the separation target liquid can 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 described in Supplementary Note 7, wherein the inner diameter of the nozzle portion is made smaller toward the bottom end portion side.

[0251] The separation device of Supplementary Note 9 includes a container having an opening end portion provided with an opening and a bottom end portion provided so as to face the opening end portion, and the separation insert described in Supplementary Note 1 or 2.

[0252] The separation method of Supplementary Note 10 is 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 centrifugation operation is performed on the container containing the separation target liquid containing the sample, using a separation insert accommodated in the container. The container has an opening end portion provided with an opening and a bottom end portion provided so as to face the opening end portion. The separation insert has a partition means for partitioning the internal space of the container into a first internal space which is the space on the bottom end portion side and in which the first separation component is accommodated after the centrifugation operation, and a second internal space which is the space on the opening end portion side and in which the second separation component is accommodated after the centrifugation operation, and a support means for supporting the partition means with respect to the container. The separation insert further includes an insert opening provided in the partition means, and the insert opening enables the separation target liquid to flow from at least one of the first internal space and the second internal space to the other through the insert opening during the centrifugation operation. The separation method includes a dispensing step of dispensing the separation target liquid into the container, a separation step of separating the components of the sample into the first separation component and the second separation component by performing the centrifugation operation on the container containing the separation target liquid after the dispensing step, and a separation step of separating the second separation component after the centrifugation step. In the separation step, during the centrifugation operation, at least a part of the insert main body floating on the separation target liquid in the accommodation state where the separation target liquid is accommodated in the container pushes up the first separation component toward the opening end portion side, and the first separation component is moved from the second internal space to the first internal space through the insert opening.

[0253] (Effect of Supplementary Note) With the separation insert described in Appendix 1, or the separation apparatus described in Appendix 6, the insert body is configured such that at least a portion of the insert body can float in the liquid to be separated when contained. Therefore, when at least a portion of the insert body floats in the liquid to be separated when contained, the first separation component and the second separation component can be effectively separated during the centrifugation operation regardless of the state of the sample. Thus, when decantation is performed after the centrifugation operation, the first separation component can not be mixed with the second separation component, and preparative separation can be performed with high purity.

[0254] According to the separation insert described in Appendix 2, the insert body is configured such that, in the contained state, the partition means and the first support means can float on the liquid to be separated, while the second support means cannot float on the liquid to be separated. Therefore, in the contained state, the partition means and the first support means float on the liquid to be separated, allowing for effective separation of the first separation component and the second separation component during centrifugal separation, regardless of the state of the sample. Furthermore, when the liquid to be separated is not contained, the partition means and the first support means can be supported in the container via the second support means, improving the ease of installation of the insert body within the container.

[0255] According to the separation insert described in Appendix 3, by making the diameter of the partitioning means approximately the same as the inner diameter of the container, and by not providing any notches or openings other than the insert opening in the partitioning means, it is 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. As a result, at least a part of the insert body can be effectively floated in the liquid to be separated in the containment state.

[0256] According to the separation insert described in Appendix 4, since the second partition is provided on the open end side of the second support means, compared to the case where the second partition is provided on the bottom end side of the second support means, it is easier to avoid the first separated component (especially the easily suspended component of the first separated component) mixing with the second separated component when decantation is performed after centrifugation, thus enabling separation with high purity.

[0257] According to the separation insert described in Appendix 5, since the flange is provided at the bottom end of the support body, compared to the case where the flange is provided at the open end of the support body, it is possible to avoid the first separation component mixing with the second separation component when the first separation component exists between the partitioning means and the flange, and to perform separation with high purity.

[0258] According to the separation insert described in Appendix 6, the flange 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 is substantially aligned with the inner surface of the container. Compared to the case where the flange is provided at the end of the support body on the bottom end side, it is easier to avoid the first separated component (especially the easily suspended component of the first separated component) mixing with the second separated component when decantation is performed after centrifugation, thus enabling separation with high purity.

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

[0260] According to the separation insert described in Appendix 8, the inner diameter of the nozzle section is made smaller towards the bottom end. Therefore, according to Newton's law of viscosity, the velocity of the liquid to be separated can be increased as it flows towards the bottom end within the nozzle section. Thus, compared to the case where the inner diameter of the nozzle section is uniform, the first and second separation components can be effectively separated during the centrifugal separation operation, and the efficiency of the separation can be increased.

[0261] According to the separation method described in Appendix 10, during the separation step, at least a portion of the insert body, which floats in the liquid to be separated in the containment state, pushes the first separation component toward the opening end, thereby moving the first separation 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 liquid to be separated in the containment state, the first separation component and the second separation component can be effectively separated during the centrifugation operation regardless of the state of the sample. Thus, when decantation is performed after the centrifugation operation, contamination of the first separation component with the second separation component can be avoided, and preparative separation can be performed with high purity. [Explanation of Symbols]

[0262] 1 Separation device 10 containers 11 Container body 11a Open end 11b Bottom end 11c Side wall part 11d Bottom part 12 Aperture 13 Lid 20 Separation Inserts 30 Insert body 40 First partition section 50 Second partition section 60 Support part 61 1st support part 62 Second support part 63 Support body part 64 Guard section 70 Nozzle section 80 First insert opening 90 Second insert opening IS interior space IS1 1st interior space IS1a Bottom 1st internal space IS1b Opening side 1st internal space IS2 2nd internal space LS separation target liquid LS1 Specific gravity separation liquid LS2 sample solution S1 1st 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. By making the diameter of the partition means substantially the same as the inner diameter of the container, and by not providing any notches or openings other than the insert opening in the partition means, it is 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 contained state. The separation insert according to claim 1.

3. The separation insert is, A second partition portion provided in the insert body, 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 portion 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 provided with a nozzle portion that protrudes from the partition means toward the bottom end, and the nozzle portion 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. 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 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 centrifugation 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 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, Following the dispensing step, a centrifugation step is performed on the container containing the liquid to be separated to separate 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 centrifugal 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.

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