JP2008076158A - Blood separation device - Google Patents

Abstract

A blood separation device capable of quickly and efficiently separating blood into a blood cell component and a plasma or serum component and reliably obtaining a plasma or serum component that is less contaminated by hemolysis or the like.
The blood pressure is reduced, the stopper 3 is airtightly attached to an opening 2a of a cylindrical container body 2, and blood is separated into blood cell components and plasma or serum components. A cylindrical structure including a cylindrical body 5 made of a film and a cylindrical support member 6 that is inserted into the cylindrical body 5 and supports the cylindrical body 5 is disposed. 5 from the outside of the outer peripheral side surface to the first end side on the opening 2a side, and the second inside from the inside of the support member 6 to the second end side of the container body 2 A blood separation device 1 that is airtightly and liquidtightly partitioned from the space B.
[Selection] Figure 1

Description

  The present invention relates to a blood separation apparatus capable of performing from the collection of blood to the collection of separated plasma or serum components.

  Conventionally, centrifugation has been used to remove blood cell components from blood and obtain plasma or serum necessary for clinical examination. However, in the centrifugal separation method, operations such as the coagulation process and the process of transferring the supernatant plasma or serum after the separation are complicated. Moreover, it took time to obtain the test result, and a large and expensive centrifuge was required.

  In order to solve this problem, various instruments have been proposed that can remove blood cell components from blood and obtain plasma or serum necessary for clinical examination without using a centrifuge.

  Patent Document 1 below discloses an example of a blood test container that makes it possible to separate plasma or serum from collected blood and to take out the separated plasma or serum. With reference to FIG. 6, the blood test container shown in Patent Document 1 will be described.

  As shown in a longitudinal sectional view in FIG. 6, the blood test container 101 is an airtight container having an outer tube 102, a cylindrical member 103, and a plug 104, and the inside is decompressed. A cylindrical member 103 is inserted into the outer tube 102. The outer tube 102 is a bottomed tubular container, and the outer tube 102 has an opening 102a at the upper end.

  On the other hand, the cylindrical member 103 has an opening 103a at its upper end. A filter 105 is accommodated in the lower part of the cylindrical member 103. The filter 105 includes a filter member 106 and a blood cell stop film 107 disposed below the filter member 106. The filter member 106 is made of a filter material that moves plasma or serum faster than blood cell components. The blood cell stop film 107 is provided for capturing blood cells and preventing the blood cells from being mixed into the separated plasma or serum.

  A protruding portion 103 b protruding downward is formed at the lower end of the cylindrical member 103. A plasma or serum channel 108 is provided in the protrusion 103b. The plasma or serum channel 108 is provided so as to face the lower surface of the blood cell stop film 107 and to extend downward in the protrusion 103b. The plasma or serum separated by the filter member 106 flows down from the plasma or serum channel 108 to the lower plasma or serum storage unit 109. The space above the filter member 105 constitutes the blood storage part 110.

  The plug 104 includes a grip portion 104a, a large diameter portion 104b, and a small diameter portion 104c. The large diameter portion 104b has a larger diameter than the small diameter portion 104c. The small diameter portion 104 c is press-fitted into the opening 103 a of the cylindrical member 103, and the large diameter portion 104 b is press-fitted into the opening 102 a of the outer tube 102.

  When the blood test container 101 is used, blood is collected in the blood storage unit 110 by a pressure difference between the inside and outside by inserting a blood collection needle through the plug 104. The collected blood is filtered by the filter 105. As described above, in the filter member 106, plasma or serum moves downward faster than the blood cell component. Then, plasma or serum passes through the blood cell stop membrane 107 and reaches the plasma or serum channel 108. Thereafter, the plasma or serum flows down to the plasma or serum storage unit 109. On the other hand, blood cells are captured by the blood cell stop film 107. When the blood cell stop film 107 is blocked by blood cells, the filtration is stopped.

After the plasma or serum is separated, the plug 104 that is press-fitted into the opening 102 a of the outer tube 102 is removed together with the tubular member 103. In this way, the separated plasma or serum can be removed.
JP 2004-325412 A

  In the blood test container 101 described in Patent Document 1, blood cells are captured by the blood cell stop film 107, the blood cell stop film 107 is blocked, and filtration stops. However, when the filter is left for a long time after the filtration is finished, the red blood cells captured by the blood cell stop film 107 may be destroyed, and the components in the red blood cells may leak. The leaked erythrocyte component is temporarily stored in the plasma or serum flow path 108, but a part thereof flows down to the plasma or serum storage unit 109, and there is a possibility that the erythrocyte component is mixed into the plasma or serum.

  Furthermore, when taking out the separated plasma or serum, the plug 104 must be removed from the outer tube 102 together with the tubular member 103. When the plug 104 is removed from the outer tube 102 together with the tubular member 103, vibration tends to be applied to the tubular member 103. For this reason, the red blood cells captured by the blood cell stop film 107 are destroyed, the components in the red blood cells leak, and the components in the red blood cells tend to be mixed into plasma or serum. In addition, when vibration is applied to the cylindrical member 103, there is a possibility that the components in the red blood cells stored in the plasma or serum flow path 108 may flow down to the plasma or serum storage unit 109.

  The object of the present invention is to allow blood to be efficiently separated into blood cell components and plasma or serum components in a short time in view of the current state of the prior art described above. It is an object of the present invention to provide a blood separation device that can be suppressed and that allows a laboratory technician to easily extract plasma or serum components separated without being infected with a pathogen.

  The present invention relates to a blood separation device for separating and collecting plasma or serum components in blood from blood cell components, and a first end and a second end opposite to the first end. A cylindrical container body having an opening from which blood is collected on the first end side, and is hermetically attached to the opening of the container body and is pierced by a hollow needle. A plug made of a permeable material, and a blood separation membrane that separates blood into blood cell components and plasma or serum components, and is arranged in the container body, and the second end side of the container body is The cylindrical body that is opened and the outer peripheral side surface are in contact with the inner peripheral side surface of the cylindrical body, and the cylindrical body is supported in the container body. And the cylindrical support part in which the several through-hole from the outer peripheral side surface to an inner peripheral side surface is formed The inner end of which is reduced in pressure, and the end on the first end side of the cylindrical structure in which the cylindrical body is extrapolated to the cylindrical support member is closed, and the plurality The outer peripheral side surface of the cylindrical body or the open end surface of the cylindrical body is hermetically fixed to the container main body on the second end side of the container main body from the portion where the through hole is provided. A fixing portion is provided, whereby movement of blood toward the second end side of the fixing portion is restricted, and the internal space in the container body is an outer periphery of the cylindrical body. Partitioned into a first internal space that extends from the outside of the side surface to the first end of the container body, and a second internal space that extends from the inside of the cylindrical body to the second end of the container body. It is characterized by.

  In the blood separation device according to the present invention, preferably, the second end portion of the cylindrical container body is closed, and therefore, the cylindrical container body is constituted by a bottomed cylindrical container. Yes. In this case, a container main body can be comprised with a general purpose bottomed tubular container like a test tube. Therefore, the cost of the blood separation device can be reduced.

  In the blood separation device according to the present invention, preferably, an inner tube that is inserted into the cylindrical container body and into which a cylindrical structure including the cylindrical body and the support member is inserted is further provided. An end of the inner tube on the first end side of the container body is open, and the opening is hermetically attached to the stopper, and the container of the inner tube A portion on the second end side of the main body is hermetically fixed to the cylindrical body to constitute the fixing portion, whereby the outer peripheral side surface of the cylindrical body is configured to connect the inner tube with the fixing portion. The first internal space is fixed to the container body through the space between the outer peripheral side surface of the cylindrical body and the inner peripheral side surface of the inner tube. It is formed so as to reach the end side. In this case, the second end side portion of the inner tube container main body is airtightly fixed to the cylindrical body, and the fixing portion, that is, the fixed portion in which the cylindrical body is airtightly fixed to the container main body is provided. It is configured. And since this fixing | fixed part is located in the 2nd edge part side of the container main body rather than the part in which the several penetration part is provided, the blood supplied in the 1st internal space is the said cylindrical body And it is possible to reliably lead to the second internal space via the through hole provided in the support member.

  In particular, it is preferable that the inner tube is detachably connected to the container body. In this case, after separating plasma or serum, a cylindrical structure including the cylindrical body and the support member is provided. It can be taken out from the container body together with the inner tube, and the separated plasma or serum can be easily collected.

  In the blood separation device according to the present invention, preferably, the cylindrical container body is provided on the first end as the opening provided on the first end side and on the second end side. And a second plug body hermetically attached to the second opening. In this case, the plasma or serum component separated from the second internal space side can be easily taken out by removing the second stopper from the second opening.

  In the blood separation device according to the present invention, an end of the cylindrical body on the first end side of the container main body is opened, and the support member is the first end of the cylindrical body. It has a top plate that closes the end on the side. In this case, the end portion on the first end side of the container body having a cylindrical structure including a cylindrical shape and a supporting body is reliably closed by the top plate portion. And since the blood supplied to the first internal space first flows down to the top plate portion and spreads toward the outer peripheral line of the top plate portion, the blood spreads and flows down over the entire outer peripheral side surface of the cylindrical body. Therefore, filtration is performed quickly, and an increase in load on red blood cells due to delay in filtration can be suppressed. Therefore, the destruction of red blood cells hardly occurs.

  In the blood separation device according to the present invention, the end of the support member on the second end side is open, and the inside of the support member forms part of the second internal space. Is desirable. In this case, since the inside of the support member constitutes a part of the second internal space, the volume of the first internal space can be increased, thereby allowing more rapid filtration without causing hemolysis. It is possible to carry out in a stable and stable manner.

  In the blood separation device according to the present invention, preferably, the liquid is disposed on the second internal space side with respect to the cylindrical body, and in order to prevent the liquid component from flowing into the second internal space side, A flow path blocking member that expands and blocks the flow path when contacting the component is further provided. In this case, after the filtration is completed, the flow path is reliably blocked by the flow path blocking member, and contamination of the separated plasma or serum component can be suppressed.

  In the present invention, the inside is decompressed, and the steps from collection of blood to separation of blood into plasma or serum components and blood cells and collection of plasma or serum components are performed using only the blood separation device of the present invention. And can be completed in the blood separation device.

  In addition, blood is collected on the first internal space side, and filtration proceeds due to the pressure difference between the first and second internal spaces, so that plasma or serum components can be collected without requiring centrifugation. it can. Moreover, since the plasma or serum component is separated from the blood cell component using the cylindrical body composed of the blood cell separation membrane, and the cylindrical body is composed of the blood cell separation membrane, the filtration area can be increased, It is possible to shorten the separation time.

  The second internal space is provided so as to reach from the inside of the cylindrical body to the second end portion side of the container body, and the volume of the second internal space is larger than the first internal space. Therefore, even when the pressure difference ΔP between the first and second internal spaces is reduced, a sufficient filtration pressure can be maintained.

  Therefore, since the pressure difference during separation can be reduced, the pressure load on the blood cell component is reduced. Therefore, hemolysis can be reliably suppressed.

  Moreover, since the cylindrical body is supported by the inner peripheral side surface of the cylindrical body being in contact with the outer peripheral side surface of the support member, the cylindrical body is hardly deformed. Therefore, it is possible to prevent a reduction in filtration rate due to deformation of the cylindrical body.

  Therefore, according to the present invention, it is possible to cause hemolysis by using only the blood separation device of the present invention without the need for a centrifugal separator to obtain plasma or serum components after collecting a blood sample. And plasma or serum components can be collected quickly.

  Hereinafter, the present invention will be clarified by describing specific embodiments of the present invention with reference to the drawings.

  FIG. 1 is a front sectional view of a blood separation device according to a first embodiment of the present invention, and FIG. 2 is a perspective view showing a support member used in the blood separation device.

  The blood separation device 1 has a cylindrical container body 2. The container body 2 is not limited to a cylindrical shape, and may have another cylindrical shape such as a rectangular tube shape.

  About the material which comprises the container main body 2, as long as it is a material which has air impermeability, it will not specifically limit. Examples of such materials include thermoplastic resins such as polyethylene terephthalate, polyethylene, polypropylene, polystyrene, polymethyl methacrylate, polyacrylonitrile, polyamide, acrylonitrile-styrene copolymer, and ethylene-vinyl alcohol copolymer, and unsaturated. Thermosetting resins such as polyester, epoxy resin, and epoxy-acrylate resin, modified natural resins such as cellulose acetate, cellulose propionate, ethyl cellulose, and ethyl chitin, and silicic acid such as soda lime glass, phosphosilicate glass, and borosilicate glass Conventionally known materials such as glass such as salt glass and quartz glass, and those containing these as the main components, or combinations thereof, may be mentioned. When the container main body 2 is made of a synthetic resin, metal, silicon, or the like may be deposited on the surface, thereby improving the air non-permeability performance.

  The dimensions of the container body 2 are not particularly limited, but considering the suitability for a general clinical verification equipment rack, for example, a substantially cylindrical body having an outer diameter of about 16 mm and a length of up to about 100 mm is desirable.

  As shown in FIG. 1, the container body 2 has an opening 2 a that is an opening on the side where blood is collected on the first end side. The second end side opposite to the side where the opening 2a is provided is closed. Therefore, the container body 2 is constituted by a bottomed cylindrical tubular container. Therefore, the container main body 2 can be formed of a commonly used bottomed tubular container such as a commercially available test tube.

  A stopper 3 is airtightly attached to the opening 2 a of the container body 2. The plug 3 includes an outer diameter portion 3a, a medium diameter portion 3b having a diameter smaller than that of the outer diameter portion 3a, and a small diameter portion 3c having a diameter smaller than that of the medium diameter portion 3b. In addition, a thin portion 3d is provided in the center of the stopper 3 so that a hollow needle such as a syringe can be easily inserted. The plug 3 is made of an appropriate material that is impermeable to air and can be pierced by a hollow needle. Examples of such a material include elastic bodies such as natural rubber, butyl rubber, isoprene rubber, or thermoplastic elastomer.

  The middle diameter portion 3 b of the plug body 3 is press-fitted into the container body 2 from the opening 2 a of the container body 2, whereby the plug body 3 is hermetically attached to the opening 2 a of the container body 2. Accordingly, the middle diameter portion 3b is sized to be hermetically press-fitted into the opening 2a of the container body 2, and the outer diameter portion 3a is larger than the diameter of the middle diameter portion 3b. On the other hand, an inner tube 4 is inserted into the container body 2. The inner tube 4 is constituted by a cylindrical container having an opening 4a at the upper end. The inner diameter of the opening 4a is such that the small-diameter portion 3c of the plug body 3 is press-fitted, whereby the small-diameter portion 3c is airtightly attached to the inner tube 4 from the opening 4a of the inner tube 4. Yes.

  About the material which comprises the inner tube | pipe 4, the material similar to the material which comprises the container main body 2 can be used.

  The inner tube 4 is detachably disposed with respect to the container body 2. As shown in FIG. 1, in this embodiment, the outer peripheral side surface of the inner tube 4 is in contact with the inner peripheral side surface of the container body. That is, the outer diameter of the inner tube 4 and the inner diameter of the container body 2 are made equal. However, the outer diameter of the inner tube 4 may be smaller than the inner diameter of the container body 2.

  A bottom 4b is provided below the inner tube 4, that is, on the second end side of the container body 2. A through hole is provided in the center of the bottom 4b.

On the other hand, on the second end portion side of the container body 2, a plurality of ribs 2b projecting inward from the inner peripheral side surface are provided. The upper end of the rib 2b is in contact with the bottom 4b of the inner tube 4. The rib 2b is not essential, but by providing the rib 2b, when the inner tube 4 is inserted into the container body 2, the insertion depth can be regulated and the posture of the inner tube 4 can be stably maintained.

  In the container main body 2, a cylindrical body 5 made of a blood separation membrane is disposed inside the inner tube 4 while being supported by a cylindrical support member 6. In this embodiment, the cylindrical body 5 is formed by forming a blood separation membrane into a cylindrical shape. As the blood flow separation membrane, a membrane made of a material having an appropriate blood separation performance capable of separating the blood flow into a plasma or serum component and a blood cell component can be used. Therefore, as the blood separation membrane, plasma or serum components can be moved more quickly than blood cell components, and the number of pores or voids that can ensure a practical filtration time, that is, plasma or There is no particular limitation as long as it has a shape that does not physically or chemically inhibit the movement of serum components. Further, the material used for the blood separation membrane is not particularly limited as long as such a requirement is satisfied.

  The thickness of the blood separation membrane is not particularly limited, but is preferably 5 mm or less, more preferably 2.5 mm or less because it is preferable that the amount of blood captured during separation is not excessive. desirable. In order to quickly filter a sufficient amount of blood, the thickness of the blood separation membrane is preferably 5 μm or more, more preferably 10 μm or more.

  The surface shape of the blood separation membrane is not particularly limited as long as it does not cause physical or chemical damage to blood cell components.

Examples of the material for the blood separation membrane include polyethylene terephthalate, polystyrene, polysulfone, polyethersulfone, polypropylene, various synthetic resins such as fluorinated ethylene resin, polycarbonate, and acrylic resin, or cellulose and glass.
As the processed shape, for example, a fiber in which the above-mentioned material is molded is accumulated in a nonwoven fabric, a molded body such as an open-cell foam in which continuous holes made of the above-described material are formed, and a through-hole is formed in a film in which the above-described material is molded. What was formed is mentioned.

  The cylindrical body 5 is formed by forming the blood separation membrane into a cylindrical shape. In this case, the blood separation membrane may have a large number of through-holes in order to proceed with filtration quickly. desirable. On the other hand, in this blood separation membrane, it is preferable that the pore diameter on the blood inlet side and the pore diameter on the blood plasma or serum component outlet side are different. More preferably, a through hole provided with a taper from the inflow side to the outflow side is desirable. As a result, clogging due to red blood cells on the inflow side is less likely to occur. Therefore, the recovery rate of plasma or serum components can be increased.

  The blood separation membrane is preferably one that does not allow blood cell components to pass through. Thereby, contamination of blood cells into plasma or serum components can be surely prevented. In the case of a blood separation membrane that does not pass blood cell components, it is preferable that the pore diameter of the penetrating membrane is 0.2 to 2 μm in average flow pore diameter at the smallest part of the flow path.

  The average flow pore size of the blood separation membrane is a pore size measured by a bubble point method based on JIS K3832. When the average flow pore size is smaller than 0.2 μm, clogging due to blood cell components and proteins tends to occur, and filtration may be stopped. If the average flow pore size is larger than 2 μm, red blood cells are likely to pass through, and the blood separation accuracy may be reduced.

  Further, in order to obtain plasma or serum components even more efficiently, a laminate of prefilters for delaying the moving speed of blood cell components may be used as a blood separation membrane.

Examples of the prefilter material include various synthetic resins such as glass, polyethylene terephthalate, polystyrene, polysulfone, polyethersulfone, polypropylene, fluorinated ethylene resin, polycarbonate, and acrylic resin, and cellulose.
At least one type or two or more types of prefilters may be laminated and combined.

  The thickness of the prefilter is not particularly limited, but is preferably in the range of 100 μm to 5 mm, and more preferably in the range of 500 μm to 2.5 mm so that the amount of blood trapped during separation is not excessive. .

  The pore size of the prefilter is such that the average flow pore size of the smallest pore in each channel is 2 to 10 μm with respect to all channels through which plasma or serum components present in the prefilter can pass. It is preferable to be in the range.

  When the average flow pore size of the prefilter is smaller than 2 μm, clogging due to blood cell components and proteins tends to occur, and the separation efficiency may be reduced. When the average flow pore size is larger than 10 μm, the blood cell component may not move sufficiently slower than the plasma or serum component, and the blood separation performance may not be sufficiently obtained.

  In addition, the blood separation membrane may be subjected to a surface treatment in order to increase the recovery efficiency of specimens such as plasma or serum components, or to suppress protein adsorption.

  Returning to FIG. 1, the cylindrical body 5 is formed by forming the blood separation membrane into a cylindrical shape, so that the blood flow supplemented by the blood separation membrane itself is relatively small. Therefore, plasma or serum components can be quickly separated from a small amount of blood and recovered.

  By the way, the said cylindrical body 5 has the opening 5a in the 1st edge part side of the container main body 2, ie, the blood collection side edge part. The cylindrical body 5 is supported by being externally attached to the support member 6 such that the inner peripheral side surface of the cylindrical body is in contact with the outer peripheral side surface of the cylindrical support member 6. The support member 6 has a top plate portion 6 a on the first end side of the container body 2. The top plate portion 6a closes the end portion on the first end portion side of the cylindrical structure composed of the cylindrical body 5 and the support member 6.

  On the other hand, as shown in FIG. 2, the support member 6 has a plurality of through openings 6b on the outer peripheral side surface. The through-opening 6 b is provided for guiding the plasma or serum component that has passed through the cylindrical body 5 into the support member 6. That is, it constitutes a flow path for plasma or serum components.

  On the other hand, the lower end of the support member 6, that is, the end on the second end side of the container main body 2 is provided with a protruding portion 6 c that protrudes downward from the bottom surface portion. The protrusion 6c is inserted into a through hole provided at the center of the bottom 4b of the inner tube 4 described above. The protruding portion 6c is provided with a through hole 6d, and the through hole 6d constitutes a flow path that can cause plasma or serum components to flow downward. The outer peripheral side surface of the cylindrical support member 6 is in contact with the inner peripheral side surface of the cylindrical body 5 as described above. Accordingly, the plasma or serum component reaches the through-opening 6b from the inner peripheral side surface of the cylindrical body 5 through the through-opening 6b or connects to the inner peripheral side surface, and passes through the through-opening 6b to enter the inside of the support member 6. Will be led to.

  As shown in FIG. 2, in the present embodiment, the plurality of through openings 6 b are linearly extending on the outer peripheral side surface of the support member 6 in the substantially circumferential direction. Other shapes may be used.

  It does not specifically limit about the material which comprises the said supporting member 6, As long as it has the shape retention property which can support the cylindrical body 5, it does not specifically limit. Examples of such a material include an appropriate synthetic resin.

  Further, the lower end of the cylindrical body 5 and the lower end of the support member 6, that is, the opening end surface located on the second end side of the container body 2 are airtight on the upper surface of the bottom portion 4 b of the inner tube 4 described above. And it is fixed fluid-tight. This fixing may be performed using an adhesive. Therefore, the cylindrical body 5 and the support member 6 are arranged so that the inner tube 4 is connected to the inner peripheral surface of the container body 2 on the second end side of the container body 2 with respect to the portion where the through opening 6b is provided. Airtightly fixed through. A portion where the lower end of the cylindrical body 5 and the lower end of the support member 6 are liquid-tightly and airtightly fixed to the upper surface of the bottom portion 4b of the inner tube 4 constitutes a fixing portion in the present invention.

  On the other hand, the inside of the blood separation apparatus 1 is decompressed in order to collect blood and filter it. Since the cylindrical body 5 and the support member 6 are indirectly fixed to the container body 2 by the fixing portion, the inside of the blood separation device 1 is a container from the outside of the outer peripheral side surface of the cylindrical body 5. Partitioned into a first internal space A that reaches the first end of the main body 2 and a second internal space B that extends from the inside of the support member 6 to the second end of the container main body 2. become.

  The pressure inside the container body 2 is not particularly limited, but may be in the range of 10 to 95 kPa in order to exert a driving force for blood filtration and prevent red blood cells from being destroyed by a load on blood cell components. Preferably, it is in the range of 30 to 70 kPa. When the pressure is higher than 95 kPa, blood collection may not be performed quickly. When the pressure is lower than 10 kPa, red blood cells are destroyed and components in red blood cells are likely to leak. Furthermore, when the internal pressure of the container body is in the range of 10 to 95 kPa, in the process in which plasma or serum components in the blood are guided to the second internal space B, the first internal space A and the first The pressure difference between the two internal spaces B can be maintained at a sufficient level, and plasma or serum components can be separated efficiently in a shorter time.

  With reference to FIG. 3, the usage method of the said blood separation apparatus 1 is demonstrated. In use, the hollow needle 11 is pierced through the plug 3 as shown in the leftmost drawing of FIG. In this case, the tip of the hollow needle 11 is positioned in the first internal space A so that the tip of the hollow needle 11 is positioned above the top plate portion 6 a of the support member 6. In order to prevent the hollow plate 11 from penetrating the top plate portion 6 a, it is desirable that the top plate portion 6 a and the support member 6 be made of a material that is not pierced by the hollow needle 11.

  When the outer end of the hollow needle 11 communicates with blood vessels or blood in the already collected syringe or blood in the blood collection container, the inside of the blood separation device 1 is decompressed, so that the blood passes through the hollow needle 11, It will be sucked into the first internal space A.

  Then, as shown in the second diagram from the left in FIG. 3, the blood 12 is collected in the first internal space A. Since the pressure in the second internal space B is lower than the pressure in the first internal space A communicating with the outside, as shown in the third diagram from the left in FIG. proceed. That is, blood flows into the cylindrical body 5 from the outer peripheral side surface of the cylindrical body 5, and plasma or serum components quickly move from the inner peripheral side surface of the cylindrical body 5 to the outer peripheral side surface of the support member 6, It moves through the through opening 6b and into the support member 6.

  Then, as shown in the fourth diagram from the left in FIG. 3, the plasma or serum component flows down from the inside of the support member 6, and the plasma or serum component 13 flows to the second end side of the container body 2. Will be collected.

  Filtration is stopped when the pressure difference ΔP between the first and second internal spaces A and B disappears. In this case, some blood 12 may remain outside the cylindrical body 5. Even in that case, the filtration is stopped when the pressure difference ΔP becomes zero. In this state, as shown in the rightmost drawing of FIG. 3, the container body 2, the plug body 3, the inner tube 4, the cylindrical body 5 disposed in the inner tube 4, and the support member 6 are included. What is necessary is just to pull out a cylindrical structure. As a result, the opening 2a of the container body 2 is exposed, and the plasma or serum component 13 collected at the bottom of the container body 2 can be quickly taken out by a pipette or the like.

  Therefore, according to the blood separation device 1 of the present embodiment, the plasma or serum component 13 is removed from the step of inserting the hollow needle 11 through the plug 3 and collecting blood into the blood separation device 1 using a pipette or the like. It can be seen that the steps up to the recovery can be performed quickly and easily without using a centrifuge. Moreover, since the second internal space B is larger than the first internal space A, plasma or serum components can be quickly separated without increasing the pressure difference ΔP so much. Hemolysis can be prevented, and uncontaminated plasma or serum component 13 can be reliably collected.

  FIG. 4 is a front cross-sectional view showing a blood separation device according to the second embodiment of the present invention. The blood separation device 31 of the second embodiment has a substantially cylindrical container body 32. The container body 32 may have another cylindrical shape such as a rectangular tube shape.

  The container body 32 used in the present embodiment has a first opening 32a at a first end which is an end from which blood is collected, and a second end opposite to the first end. A second opening 32b is provided at the end. The container main body 32 has a shelf 32c that protrudes radially inward from the inner peripheral side surface of the cylindrical container main body 32 between the first end and the second end. A space above the shelf 32c and a space below the shelf 32c are separated by the shelf 32c. The shelf c is provided with a flow path 32d having a very small inner diameter compared to the space below from above. The upper and lower spaces of the shelf portion 32c communicate with each other through the flow path 32d.

  The container main body 32 can be comprised with the material similar to the container main body 2 used in 1st Embodiment. Further, it is desirable that the outer dimensions of the container body 32 be the same as those of the container body 2.

  A first plug 33 is attached to the first opening 32a in an airtight and liquidtight manner. The first plug 33 can be made of the same material as the plug 3 used in the first embodiment. The first plug 33 has an outer diameter portion 33a and a small diameter portion 33b having a smaller diameter than the outer diameter portion 33a. The small portion 33b is press-fitted into the opening 32a, and the first opening 32a is hermetically sealed by the first plug 33. Further, the first plug 33 is provided with a thin portion 33c for facilitating the insertion of the hollow needle.

  A second plug 34 is press-fitted into the second opening 32b. Thereby, the second opening 32b is closed in an airtight and liquid-tight manner.

  As long as the second plug 34 can be removed from the second opening 32b side and the second opening 32b can be liquid-tight and air-tightly closed, an appropriate material such as an elastic body can be used. Can be configured. As such a material, the material similar to the material which comprises the plug 3 used in 1st Embodiment can be used.

  Further, a cover 35 is provided so as to cover the second plug body 34. The cover 35 can be made of an appropriate synthetic resin or metal. The cover 35 makes a distinction between the side on which the first plug body 33 is provided and the side on which the second plug body 34 is provided, and a blood collection needle or a hollow needle is mistakenly attached to the second plug body 34. It is provided to prevent piercing. However, the cover 35 is not necessarily provided.

  In the container main body 32, the cylindrical body 36 is supported above the shelf 32 c so that the outer peripheral side surface is in contact with the inner peripheral side surface of the cylindrical body 36 and the cylindrical body 36. A cylindrical structure comprising a cylindrical support member 37 is inserted. The cylindrical body 36 is configured by forming a blood separation membrane for separating blood from a blood cell component and plasma or serum component into a cylindrical shape. As such a material, in the first embodiment, The same material as that constituting the cylindrical body 5 can be used. Further, the support member 37 can be formed of the same material as that of the support member 6 used in the first embodiment. The support member 37 has a top plate portion 37a on the first end portion side of the container body 32, whereby the end portion on the first end portion side of the cylindrical structure is closed. This structure is the same as the cylindrical body 5 and the support member 6 in the first embodiment.

  Also in the support member 37, similarly to the support member 6, a plurality of linear through openings 37 b are provided so as to penetrate from the outer peripheral side surface to the inner peripheral side surface. In the support member 37, a bottom surface portion 37c is provided below, and a through hole 37d is provided in the center of the bottom surface portion 37c. The through hole 37d communicates with the flow path 32d. Therefore, the inside of the support member 37 communicates with the space below the shelf portion 32c via the flow path 32d. In the present embodiment, the opening end surface end portion, which is the lower end portion of the cylindrical body 36, is airtightly and liquid tightly joined to the upper surface of the shelf portion 32d to constitute a fixed portion. Therefore, the inside of the container main body 32 passes through the first internal space A from the outer peripheral side surface of the cylindrical body 36 to the first end side of the container main body 32 and the flow path 32d from the inside of the support member 37, It is partitioned into a space below the shelf 32c, that is, a second internal space B that is a space reaching the second end side of the container body 32. Therefore, the volume of the second internal space B is sufficiently larger than that of the first internal space A.

  Also in the present embodiment, as in the case of the blood separation device 1 of the first embodiment, the inside is depressurized, and as described later, due to the pressure difference ΔP between the first and second internal spaces, Filtration proceeds and plasma or serum components are rapidly separated from the blood.

  A channel blocking member 38 is provided in a part of the channel 32d. The flow path blocking member 38 is a plate-shaped member having a through hole 38a surrounding the flow path 32d. The flow path blocking member 38 can be made of an appropriate material that swells when it comes into contact with a liquid component such as plasma or serum component, closes the through hole 38a, and blocks the flow path. Such a material is not particularly limited, but a resin having a hydrophilic functional group in the molecular skeleton and capable of absorbing the same amount or more of water with respect to its own weight is preferable.

  Specific examples of the material of the flow path blocking member 38 include polyacrylic acid alkali metal salt-based resins or copolymers thereof and cross-linked products thereof, polyacrylamide-based resins or copolymers thereof and cross-linked products thereof, poly N- Vinylacetamide resins or copolymers thereof and cross-linked products thereof, silicon-based resins or copolymers thereof and cross-linked products thereof, polyvinyl ether resins and copolymers thereof and cross-linked products thereof, polyalkylene oxide resins or the same Examples thereof include copolymers and their crosslinked products, polyvinyl alcohol, polyvinyl pyrrolidone or copolymers thereof, and their crosslinked products.

  As the flow path blocking member 38, a powdered or granular material may be used, or a film or sheet shaped material may be used. If the flow path blocking member 38 is formed into a sheet shape, it is easy to install in the flow path. As the flow path blocking member 38, a paste, slurry, solution or the like may be used, and this may be added and dried.

  The flow path blocking member 38 swells itself by being in contact with plasma or serum components, and closes the flow path. Therefore, the required amount of the flow path blocking member 38 varies depending on the volume of the closed flow path, the swelling rate and the swelling speed of the flow path blocking member 38. Therefore, the optimum amount of the channel blocking member 38 is calculated from the channel volume to be closed, the swelling rate and the swelling speed of the channel blocking member 38.

  The channel volume to be closed is set in a range where moisture in the blood is absorbed and the collected amount of the sample does not decrease. When the volume of the flow path increases, the amount of the flow path blocking member 38 for blocking increases, which may reduce the amount of collected sample.

  Therefore, the closed channel volume is preferably in the range of 0.005 to 1.0 cm 3. The volume of the flow path blocking member 38 is preferably in the range of 5 to 95% with respect to the flow path volume to be closed. If the volume of the flow path blocking member 38 is smaller than 5% of the flow path volume to be blocked, the time until the flow path is closed becomes longer, so components leaked from the red blood cells are mixed into the separated plasma or serum. There is a fear. If the volume of the flow path blocking member 38 is larger than 95% with respect to the flow path volume to be blocked, the flow path may be blocked before all the plasma or serum components are collected, and the recovery efficiency of plasma or serum components May decrease. Note that the flow path blocking member 38 is not necessarily provided.

  Next, the usage method of the blood separation apparatus 31 of 2nd Embodiment is demonstrated with reference to figures.

  Also in this embodiment, the hollow needle 41 is pierced through the first plug 33 as shown in the leftmost drawing of FIG. As a result, since the pressure inside the blood separation device 31 is reduced, blood is guided to the first internal space A due to the pressure difference. That is, as shown in the second diagram from the left in FIG. 5, the blood 42 is guided to the outside of the cylindrical body 36. In this case, the first internal space A is communicated with the outside, whereby a pressure difference ΔP is generated between the first and second internal spaces A and B. As described above, since the volume of the second internal space B is sufficiently larger than the volume of the first internal space A, the filtration proceeds quickly without increasing the pressure difference ΔP. Therefore, filtration proceeds promptly without causing destruction of red blood cells.

  As a result, as shown in the third diagram from the left in FIG. 5, the plasma or serum component of the blood flowing into the cylindrical body 36 made of the blood separation membrane moves quickly, and the through opening 37b of the support member 37 The plasma or serum component moves downward from the inside of the support member 37. Then, the plasma or serum component 43 is collected in the second internal space B through the flow path 32d as shown in the rightmost diagram of FIG.

  Also in this embodiment, the filtration stops when the pressure difference ΔP between the first and second inner spaces A and B becomes zero. If liquid components including plasma or serum components remain after the filtration is stopped, the flow path blocking member 38 blocks the flow path 32d.

  Therefore, in the second internal space B, there is no possibility that components in blood cells or the like flow down from above into the plasma or serum component 43 collected above the plug 34, and reliably collect plasma or serum components with little contamination. can do.

  Note that when the plasma or serum component 43 collected on the plug 34 is taken out, the cover 35 and the plug 34 may be removed.

  That is, plasma or serum components can be collected quickly from the opening 32b side.

1 is a front sectional view of a blood separation device according to a first embodiment of the present invention. The perspective view which shows the external appearance of the supporting member used by 1st Embodiment. The typical front sectional view for explaining the usage method of the blood separation device of a 1st embodiment. The front sectional view of the blood separation device concerning a 2nd embodiment. The typical front sectional view for explaining the usage method of the blood separation device of a 2nd embodiment. Front sectional drawing which shows an example of the conventional blood separation apparatus.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Blood separation apparatus 2 ... Container main body 2a ... Opening 2b ... Rib 3 ... Plug body 3a ... Outer diameter part 3b ... Medium diameter part 3c ... Small diameter part 3d ... Thin-walled part 4 ... Inner tube 4a ... Opening 4b ... Bottom part 5 ... Tube Form 5a ... Opening 6 ... Supporting member 6a ... Top plate 6b ... Through opening 6c ... Projection 6d ... Through hole 11 ... Hollow needle 12 ... Blood 13 ... Plasma or serum component 31 ... Blood separation device 32 ... Container body 32a ... 1st opening 32b ... 2nd opening 33 ... 1st plug 33a ... Large diameter part 33b ... Small diameter part 33c ... Thin part 34 ... 2nd plug 35 ... Cover 36 ... Cylindrical body 37 ... Support member 37a ... top plate part 37b ... through opening 37c ... bottom part 32c ... shelf part 32d ... flow path 38 ... flow path blocking member 38a ... through hole 41 ... hollow needle 42 ... blood 43 ... plasma or serum A ... first internal space B ... Second internal space

Claims (8)

A blood separation device for separating and collecting plasma or serum components in blood from blood cell components,
A cylindrical container body having a first end and a second end opposite to the first end, and an opening through which blood is collected on the first end; ,
A stopper made of a material that is airtightly attached to the opening of the container body and that can be pierced by a hollow needle;
It consists of a blood separation membrane that separates blood into blood cell components and plasma or serum components,
A cylindrical body that is disposed in the container body and is open on the second end side of the container body;
It is arrange | positioned in the said cylindrical body so that an outer peripheral side surface may contact the inner peripheral side surface of the said cylindrical body, The said cylindrical body is supported in the said container main body, and an outer peripheral side surface is set to an inner peripheral side surface. A cylindrical support member in which a plurality of through-holes are formed,
The inside is depressurized,
The end on the first end side of the cylindrical structure formed by extrapolating the cylindrical body to the cylindrical support member is closed,
The outer peripheral side surface of the cylindrical body or the open end surface of the cylindrical body is hermetically fixed to the container body on the second end side of the container body from the portion where the plurality of through holes are provided. The fixed portion is provided, whereby the movement of blood to the second end side from the fixed portion is restricted, and the internal space in the container body is the cylindrical body. A first internal space that extends from the outer side of the outer peripheral side to the first end of the container body, and a second internal space that extends from the inside of the cylindrical body to the second end of the container body. A blood separation device characterized by being partitioned.   The blood separation device according to claim 1, wherein the second end of the cylindrical container body is closed. An inner tube that is inserted into the cylindrical container body and into which the cylindrical structure including the cylindrical body and the support member is inserted; 1 is open at the end, and the stopper is hermetically attached to the opening;
A portion of the inner tube on the container body second end side is hermetically fixed to the cylindrical body to form the fixing portion, whereby the outer peripheral side surface of the cylindrical body is fixed to the cylindrical body. And the first inner space is between the outside of the outer peripheral side surface of the cylindrical body and the inner peripheral side surface of the inner tube. The blood separation device according to claim 2, wherein the blood separation device is formed so as to reach the first end portion side from the space.   The inner tube is detachably connected to the container main body, whereby a cylindrical structure composed of the cylindrical body and the support member can be taken out from the container main body together with the inner tube. The blood separation device according to claim 3.   The cylindrical container body has a first opening as the opening provided on the first end side, and a second opening provided on the second end side, The blood separation device according to claim 1, further comprising a second stopper body hermetically attached to the two openings.   An end of the cylindrical body on the first end side of the container body is opened, and the support member closes an end of the cylindrical body on the first end side. The blood separation device according to any one of claims 1 to 5, comprising:   The end of the support member on the second end side is open, and the inside of the support member constitutes a part of the second internal space. The blood separation device according to Item.   In order to prevent the inflow of the liquid component to the second internal space side than the cylindrical body, the liquid body expands when the liquid component comes into contact with the flow path. The blood separation device according to any one of claims 1 to 7, further comprising a flow path blocking member for blocking.

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