Blood purification device

Abstract

To provide a blood purification device capable of appropriately controlling the concentration of blood cell components contained in circulating blood.SOLUTION: A blood purification device includes: a plasma separator having a first space and a second space separated by a membrane; a blood removal-side flow path that supplies blood to the first space of the plasma separator; a blood return-side flow path that supplies blood from the first space to a subject M; a blood pump that sends blood in the blood removal-side flow path to the first space of the plasma separator; a circulation flow path that supplies blood from the blood return-side flow path to the blood removal-side flow path; a circulation pump that sends liquid from the blood return-side flow path to the blood removal-side flow path; a supply flow path that supplies plasma and / or replacement fluid to the blood removal-side flow path; a branch flow path that branches from the supply flow path and supplies plasma or replacement fluid to the circulation flow path; a branch pump that sends plasma or replacement fluid to the circulation flow path; and a control unit that controls driving of the branch pump to send part of the plasma or replacement fluid into the branch flow path so as to merge it into the circulation flow path. The connection point of the supply flow path is located on the downstream side relative to the connection point of the circulation flow path.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a blood purification device. [Background technology]

[0002] Blood purification therapy, which separates plasma components from blood taken outside the body and removes disease-causing substances from the plasma components, has been widely known. For example, Patent Document 1 describes a device configured to add a portion of the plasma separated in a plasma separator to blood from which the plasma has been separated in a plasma separator, and circulate the blood from the downstream side of the plasma separator to the upstream side via a branch between a blood return circuit and a circulation circuit. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 5547293 Summary of the Invention [Problem to be solved by the invention]

[0004] However, in conventional techniques, after adding plasma to the blood, the blood is circulated from the downstream side to the upstream side of the plasma separator via a branch between the blood return side circuit and the circulation circuit. Therefore, if the blood and plasma are not sufficiently mixed, there is a risk that blood with a high or low blood cell content will be circulated in the circulation circuit.

[0005] The present invention has been made in consideration of the above circumstances, and aims to provide a blood purification device that can appropriately control the concentration of blood cell components contained in blood circulated from downstream to upstream of a plasma separator. [Means for solving the problem]

[0006] a supply flow path that supplies plasma and / or replacement fluid to the second blood flow path; a branch flow path that branches off from the supply flow path and supplies plasma or replacement fluid from the supply flow path to the circulation flow path; a third pump that sends the plasma or replacement fluid in the branch flow path to the circulation flow path; and a control unit that controls the operation of the third pump to send a portion of the plasma in the supply flow path to the branch flow path and merge it with the circulation flow path, wherein the connection point of the supply flow path is located downstream of the connection point of the circulation flow path with the second blood flow path.

[0007] The blood collection system may further include a plasma component adsorber and a plasma collection flow path that supplies plasma from the second space of the plasma separator to the plasma component adsorber, and the supply flow path may supply plasma from the plasma component adsorber to the second blood flow path.

[0008] The plasma separator may include a plasma collection flow path that supplies plasma from the second space of the plasma separator to the plasma separator, and the plasma separator may be connected to a supply flow path to supply plasma to the supply flow path.

[0009] The blood supply system may include a fluid replacement bag connected to the supply flow path, and the supply flow path may supply plasma and replacement fluid to the second blood flow path.

[0010] The blood supply system may include a replacement fluid bag, and the supply flow path may supply replacement fluid from the replacement fluid bag to the second blood flow path.

[0011] The control unit may control the driving of the third pump to control the hematocrit value of the blood in the circulation channel.

[0012] The control unit may control the driving of the third pump based on the hematocrit value of the blood flowing in the circulation channel and the hematocrit value of the blood of the sample.

[0013] The control unit may control the driving of the second pump to circulate a portion of the blood in the second blood flow path to the circulation flow path and merge with the first blood flow path.

[0014] The control unit may control the driving of the third pump based on the speed of the second pump. [Effects of the Invention]

[0015] According to the present invention, the concentrations of blood cell components contained in circulating blood can be appropriately controlled. [Brief explanation of the drawings]

[0016] [Figure 1] 1 is a diagram showing a schematic configuration of a blood purification device according to a first embodiment. [Figure 2] FIG. 1 is a diagram showing the schematic configuration of a blood purification device according to a second embodiment. [Figure 3] FIG. 10 is a diagram showing the schematic configuration of a blood purification device according to a third embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0017] First Embodiment A first embodiment of the blood purification apparatus will be described below with reference to the drawings.

[0018] As shown in Fig. 1, the blood purification device 10 is a device used, for example, in plasma exchange (PE). Plasma exchange is a therapy in which the plasma components separated from the blood of a specimen M are discarded and replaced with an equal volume of a replacement fluid (albumin solution or fresh frozen plasma), thereby removing pathogenic substances contained in the plasma components. In plasma exchange, the separated plasma components are not re-introduced into the blood.

[0019] The blood purification device 10 includes, for example, a plasma separator 11, a blood removal side flow path 12, a blood return side flow path 13, a blood pump 14, a circulation flow path 15, a circulation pump 16, a fluid replacement bag 17, a supply flow path 18, a supply pump 19, a branch flow path 20, a branch pump 21, a waste fluid flow path 22, a waste fluid pump 23, a waste fluid tank 24, and a control unit 50.

[0020] The plasma separator 11 has a first space and a second space separated by a membrane. The membrane is porous and separates plasma components smaller than the pores from blood cells larger than the pores. As a result, the first space becomes a space through which blood cells flow, and the second space becomes a space through which plasma components flow. Blood supplied from the blood removal side flow path 12 is supplied to the first space, and the plasma permeates the membrane and is separated into the second space. The plasma separated into the second space is discharged from the waste liquid flow path 22. Furthermore, the blood from which the plasma has been separated flows out from the first space into the blood return side flow path 13.

[0021] The blood removal side flow path 12 is an example of a first blood flow path, and is provided between the specimen M and the plasma separator 11. By driving a blood pump 14 provided midway along the blood removal side flow path 12, blood is sent from the specimen M to the first space of the plasma separator 11.

[0022] The blood return side flow path 13 is an example of a second blood flow path and is provided between the specimen M and the plasma separator 11. By driving a blood pump 14, which is an example of a first pump provided midway along the blood removal side flow path 12, blood containing blood cells from which plasma components have been separated in the plasma separator 11 is sent to the specimen M.

[0023] The circulation flow path 15 is provided as a bypass flow path between the blood removal side flow path 12 and the blood return side flow path 13, and by driving a circulation pump 16, which is an example of a second pump provided at a midpoint of the circulation flow path 15, blood containing blood cells from which plasma components have been separated in the plasma separator 11 is circulated from the blood return side flow path 13 to the blood removal side flow path 12.

[0024] The supply flow path 18 is provided between the fluid replacement bag 17 and the blood return side flow path 13, and is connected to a portion of the blood return side flow path 13 downstream of the connection portion with the circulation flow path 15. As a result, the circulation flow path 15 is supplied with blood after the plasma flowing out from the plasma separator 11 has been separated, before being mixed with the replenishment liquid supplied from the supply flow path 18. The supply flow path 18 sends the replenishment liquid from the fluid replacement bag 17 to the blood return side flow path 13 by driving a supply pump 19 provided at a midpoint of the supply flow path 18. The replenishment liquid sent to the blood return side flow path 13 is mixed with a portion of the blood containing blood cells from which the plasma component has been separated in the plasma separator 11, and is sent to the specimen M via the blood return side flow path 13.

[0025] In this embodiment, "upstream" and "downstream" are determined by the flow of a liquid, such as blood, flowing through a flow path.

[0026] The branch flow path 20 branches off from the supply flow path 18 and is provided between the replacement fluid bag 17 and the circulation flow path 15. A branch pump 21, an example of a third pump provided midway along the branch flow path 20, is driven to send a replacement fluid from the replacement fluid bag 17 to the circulation flow path 15. The branch flow path 20 is a flow path directly connected to the circulation flow path 15. The replacement fluid sent to the circulation flow path 15 is sent to the blood removal side flow path 12 via the circulation flow path 15. The branch flow path 20 allows the replacement fluid to merge with the blood containing blood cells from which plasma components have been separated within the circulation flow path 15. The flow rate of the replacement fluid flowing through the branch flow path 20 can be adjusted by the branch pump 21, and the flow rate of the blood containing blood cells from which plasma components have been separated, flowing from the blood return side flow path 13 into the circulation flow path 15, can be adjusted by the circulation pump 16. The concentration of blood cell components in the circulating blood can be appropriately controlled by arbitrarily adjusting the ratio between the flow rate of the replacement fluid and the flow rate of the blood containing blood cells from which plasma components have been separated.

[0027] The waste liquid flow path 22 is provided between the plasma separator 11 and the waste liquid tank 24, and by driving the waste liquid pump 23 provided at a midpoint of the waste liquid flow path 22, the plasma components separated from the blood in the plasma separator 11 are sent to the waste liquid tank 24.

[0028] The control unit 50 is realized by, for example, a hardware processor such as a CPU (Central Processing Unit) executing a program (software). Furthermore, some or all of these components may be realized by hardware (including circuitry) such as an LSI (Large Scale Integration), an ASIC (Application Specific Integrated Circuit), an FPGA (Field-Programmable Gate Array), or a GPU (Graphics Processing Unit), or may be realized by a combination of software and hardware. The program may be stored in advance in the storage unit of the control unit 50, or may be stored on a removable computer-readable recording medium such as a DVD or CD-ROM, and installed in the storage unit of the control unit 50 by inserting the computer-readable recording medium into a drive device.

[0029] The control unit 50 controls the flow rate of blood pumped by driving each of the pumps 14, 16, 19, 21, and 23, for example, by controlling the driving of the blood pump 14, the circulation pump 16, the supply pump 19, the branch pump 21, and the waste pump 23.

[0030] The control unit 50, for example, controls the operation of the branch pump 21 to control the hematocrit value of the blood in the circulation flow path 15. The control unit 50, for example, controls the operation of the branch pump 21 based on the hematocrit value of the blood of the specimen M in the blood removal side flow path 12. The control unit 50, for example, controls the operation of the branch pump 21 so that the hematocrit value of the blood flowing in the circulation flow path 15 becomes the same as the hematocrit value of the blood of the specimen M in the blood removal side flow path 12. The hematocrit value indicates the proportion of red blood cells in the blood.

[0031] The control unit 50 may calculate the flow rate of the branch pump 21 as follows, for example, and control the branch pump 21 to achieve the calculated flow rate.

[0032] First, the following definitions are made: The hematocrit (Hct) of the sample indicates the ratio of blood cell components in the blood: a [-] (range: 0 to 1; 1 corresponds to 100%) Flow rate of blood pump 14: Qb [mL / min] Flow rate of circulation pump 16: Qr [mL / min] Flow rate of the drainage pump 23 (plasma separation flow rate): Qf [mL / min] Plasma collection rate: b[-] (range: 0 to 1), which indicates the ratio of plasma separation flow rate to blood flowing into the plasma separator 11 [Qf / (Qb+Qr)]. Flow rate of branch pump 21: Qa [mL / min]

[0033] In the initial state, blood is circulating through each of the flow paths 12, 13, and 15. The pumps 21 and 23 are stopped. Therefore, in the initial state, the Hct in flow paths 12 and 15 is a, and the Hct at inlet A of the plasma separator 11 shown in Figure 1 is also a.

[0034] When treatment begins, pumps 21 and 23 start operating, and branch pump 21 must be controlled to an appropriate value. Now consider the Hct of blood after plasma separation at outlet B of plasma separator 11. Hct at outlet B can be calculated using the following formula:

number

[0035] When this formula is expressed using the plasma collection rate b, it becomes the following formula.

number

[0036] Because the blood flowing through position C is a branch of the blood at outlet B, the Hct of the blood at position C is the same as that at outlet B. The flow rate at position C is (Qr - Qa) [mL / min].

[0037] From the above, the flow rate of branch pump 21 required to make Hct in circulation channel 15 the same hematocrit value a as that in blood removal channel 12 can be calculated using the following formula: Control unit 50 may control branch pump 21 so that the flow rate of branch pump 21 is calculated in this manner.

number

[0038] The control unit 50 controls, for example, the operation of the circulation pump 16, causing a portion of the blood in the blood return side channel 13 to merge with the circulation channel 15 and then with the blood removal side channel 12. The control unit 50 controls the operation of the branch pump 21 based on, for example, the speed of the circulation pump 16 and the plasma collection rate.

[0039] Next, the operation of the blood purification device 10 of this embodiment will be described.

[0040] In the blood purification device 10 of this embodiment, the replenishment liquid in the fluid replacement bag 17 is sent to the circulation channel 15 via the branch channel 20. That is, the replenishment liquid in the fluid replacement bag 17 is sent directly to the circulation channel 15. In this case, the replenishment liquid sent to the circulation channel 15 is mixed with blood circulated from the blood return channel 13 and then circulated to the blood removal channel 12 via the circulation channel 15. That is, the mixture of the replenishment liquid sent to the circulation channel 15 and the blood circulated from the blood return channel 13 does not pass through the branch between the blood return channel 13 and the circulation channel 15. Therefore, compared to conventional devices, the concentration of blood cell components in the blood in the circulation channel 15 can be controlled appropriately (for example, to a concentration similar to that of the blood in the blood removal channel 12). For example, although an excessively high concentration of blood cell components can cause hemolysis, the blood purification device 10 of this embodiment can reduce the risk of unintended hemolysis.

[0041] In particular, in the blood purification device 10 of this embodiment, the operation of the branch pump 21 is controlled so that the hematocrit value of the blood flowing in the circulation flow path 15 becomes the same as the hematocrit value of the blood of the specimen M in the blood removal side flow path 12. Therefore, the concentration of blood cell components contained in the circulating blood is more appropriately controlled.

[0042] Second Embodiment Next, a second embodiment of the blood purification apparatus will be described with reference to the drawings.

[0043] As shown in Fig. 2, the blood purification apparatus 10A is used for double filtration plasmapheresis (DFPP). Double filtration plasmapheresis is a therapy in which plasma components separated from the blood of a specimen M are sent to a plasma component separator to screen out pathogenic substances contained in the plasma components, and the plasma containing the pathogenic substances is discarded while the remaining plasma is returned to the specimen and replaced with a replacement liquid (albumin solution or fresh frozen plasma) in an amount equal to the discarded plasma, thereby removing the pathogenic substances contained in the plasma components.

[0044] The blood purification device 10A includes, for example, a plasma separator 11, a blood removal flow path 12, a blood return flow path 13, a blood pump 14, a circulation flow path 15, a circulation pump 16, a plasma collection flow path 25, a plasma pump 26, a plasma component separator 27, a fluid replacement bag 17, a supply flow path 18, a supply pump 19, a branch flow path 20, a branch pump 21, a waste fluid flow path 28, a waste fluid pump 29, a waste fluid tank 30, and a control unit 50.

[0045] The plasma separator 11 has a first space and a second space separated by a membrane. The membrane is porous and separates plasma components and pathogenic substances that are smaller than the pores from blood cells. As a result, the first space becomes a space through which blood cells flow, and the second space becomes a space through which plasma components flow. Blood supplied from the blood removal side flow path 12 is supplied to the first space, and the plasma components and pathogenic substances permeate the membrane and are separated into the second space. The plasma components and pathogenic substances separated into the second space are discharged from the plasma collection flow path 25. Furthermore, the blood from which the plasma has been separated flows out from the first space into the blood return side flow path 13.

[0046] The blood removal side flow path 12 is an example of a first blood flow path, and is provided between the specimen M and the plasma separator 11. By driving a blood pump 14, which is an example of a first pump provided at a midpoint of the blood removal side flow path 12, blood is sent from the specimen M to the first space of the plasma separator 11.

[0047] The blood return side flow path 13 is an example of a second blood flow path, and is provided between the specimen M and the plasma separator 11. By driving a blood pump 14 provided midway along the blood removal side flow path 12, blood containing blood cells from which plasma components and pathological substances have been separated in the plasma separator 11 is sent to the specimen M.

[0048] The circulation flow path 15 is provided as a bypass flow path between the blood removal side flow path 12 and the blood return side flow path 13, and by driving a circulation pump 16, which is an example of a second pump provided at a position midway along the circulation flow path 15, blood containing blood cells from which plasma components and pathological substances have been separated in the plasma separator 11 is circulated from the blood return side flow path 13 to the blood removal side flow path 12.

[0049] The plasma collection flow path 25 is provided between the plasma separator 11 and the plasma component separator 27, and by driving a plasma pump 26 provided midway along the plasma collection flow path 25, the plasma components separated from blood containing blood cells in the plasma separator 11 are sent to the plasma component separator 27.

[0050] The plasma component separator 27 has a first space and a second space separated by a membrane. The membrane is porous and separates plasma components smaller than the pores from pathogenic substances larger than the pores. This allows the first space to be a space through which pathogenic substances flow, and the second space to be a space through which plasma components flow.

[0051] The supply flow path 18 is provided between the fluid replacement bag 17 and the blood return flow path 13, and is connected to a portion of the blood return flow path 13 downstream of the connection portion with the circulation flow path 15. As a result, the circulation flow path 15 is supplied with blood after the plasma flowing out from the plasma separator 11 has been separated, before being mixed with the replenishment liquid supplied from the supply flow path 18. The supply flow path 18 is also connected to the plasma component separator 27, and mixes the plasma components separated from pathological substances in the plasma component separator 27 with the replenishment liquid sent from the fluid replacement bag 17. The supply flow path 18 drives a supply pump 19 provided midway along the supply flow path 18, thereby sending the replenishment liquid mixed with the plasma components to the blood return flow path 13. The replenishment liquid sent to the blood return flow path 13 is mixed with a portion of the blood containing blood cells from which the plasma components have been separated in the plasma separator 11, and is sent to the specimen M.

[0052] The branch flow path 20 branches off from the supply flow path 18 and is provided between the replacement fluid bag 17 and the circulation flow path 15. By driving a branch pump 21, which is an example of a third pump provided midway along the branch flow path 20, a mixture of replacement fluid from the replacement fluid bag 17 and plasma components separated from pathogenic substances in the plasma component separator 27 is sent to the circulation flow path 15. The branch flow path 20 is a flow path directly connected to the circulation flow path 15. The mixture sent to the circulation flow path 15 is sent to the blood removal side flow path 12 via the circulation flow path 15. The branch flow path 20 allows blood containing blood cells from which plasma components and pathogenic substances have been separated to merge with a replacement liquid (mixture) mixed with the plasma components within the circulation flow path 15. The flow rate of the replacement liquid mixed with the plasma components flowing through the branch flow path 20 can be adjusted by the branch pump 21, and the flow rate of blood containing blood cells from which plasma components have been separated, flowing from the blood return side flow path 13 into the circulation flow path 15, can be adjusted by the circulation pump 16. By arbitrarily adjusting the ratio of the flow rate of the replenishment liquid mixed with the plasma components to the flow rate of the blood containing blood cells from which the plasma components have been separated, the concentration of blood cell components contained in the circulating blood can be appropriately controlled.

[0053] The waste liquid flow path 28 is provided between the plasma component separator 27 and the waste liquid tank 30, and by driving a waste liquid pump 29 provided at a midpoint of the waste liquid flow path 28, the pathogenic substances separated from the plasma components in the plasma component separator 27 are sent to the waste liquid tank 30.

[0054] The control unit 50 is realized by, for example, a hardware processor such as a CPU (Central Processing Unit) executing a program (software). Furthermore, some or all of these components may be realized by hardware (including circuitry) such as an LSI (Large Scale Integration), an ASIC (Application Specific Integrated Circuit), an FPGA (Field-Programmable Gate Array), or a GPU (Graphics Processing Unit), or may be realized by a combination of software and hardware. The program may be stored in advance in the storage unit of the control unit 50, or may be stored on a removable computer-readable recording medium such as a DVD or CD-ROM, and installed in the storage unit of the control unit 50 by inserting the computer-readable recording medium into a drive device.

[0055] The control unit 50 controls the flow rate of blood pumped by driving each of the pumps 14, 16, 19, 21, and 26, for example, by controlling the driving of the blood pump 14, circulation pump 16, supply pump 19, branch pump 21, and plasma pump 26.

[0056] The control unit 50 controls, for example, the drive of the branch pump 21 to control the hematocrit value of the blood in the circulation flow path 15. The control of the drive of the branch pump 21 by the control unit 50 is substantially the same as in the first embodiment, and by replacing the drainage pump 23 with the plasma pump 26, the flow rate of the branch pump 21 can be calculated.

[0057] The control unit 50 controls, for example, the operation of the circulation pump 16, causing a portion of the blood in the blood return side channel 13 to merge with the circulation channel 15 and then with the blood removal side channel 12. The control unit 50 controls the operation of the branch pump 21 based on, for example, the speed of the circulation pump 16 and the plasma collection rate.

[0058] Next, the operation of the blood purification device 10A of this embodiment will be described.

[0059] In the blood purification device 10A of this embodiment, the replenishment liquid in the fluid replacement bag 17 is mixed with plasma components separated from pathogens in the plasma component separator 27 and sent to the circulation channel 15 via the branch channel 20. That is, the mixture of the replenishment liquid in the fluid replacement bag 17 and the plasma components separated from pathogens in the plasma component separator 27 is sent directly to the circulation channel 15. In this case, the mixture sent to the circulation channel 15 is mixed with blood circulated from the blood return channel 13 and then circulated to the blood removal channel 12 via the circulation channel 15. That is, the mixture does not pass through the branch between the blood return channel 13 and the circulation channel 15. Therefore, compared to conventional devices, the concentration of blood cell components in the circulation channel 15 can be more appropriately controlled (e.g., the same concentration as that of blood in the blood removal channel 12). For example, although an excessively high concentration of blood cell components can cause hemolysis, the blood purification device 10 of this embodiment can reduce the risk of unintended hemolysis.

[0060] In particular, in the blood purification device 10A of this embodiment, the operation of the branch pump 21 is controlled so that the hematocrit value of the blood flowing in the circulation flow path 15 becomes the same as the hematocrit value of the blood of the specimen M in the blood removal side flow path 12. Therefore, the concentration of blood cell components contained in the circulating blood is more appropriately controlled.

[0061] The blood purification apparatus 10A is not limited to the example shown in Figure 2. For example, the blood purification apparatus 10A does not have to have the supply pump 19 and the waste fluid pump 29. Furthermore, openable and closable valves may be provided as needed. For example, the supply pump 19 and the waste fluid pump 29 may be replaced with valves, and a valve may be provided in the supply flow path 18 downstream of the branch point of the branch flow path 20.

[0062] <Third embodiment> Next, a third embodiment of the blood purification apparatus will be described with reference to the drawings.

[0063] 3, the blood purification device 10B is used for plasma adroption (PA), a treatment method for removing disease-causing substances by passing plasma components separated from the blood of a specimen M through a plasma component adsorber.

[0064] The blood purification device 10B includes, for example, a plasma separator 11, a blood removal side flow path 12, a blood return side flow path 13, a blood pump 14, a circulation flow path 15, a circulation pump 16, a plasma collection flow path 25, a plasma pump 26, a plasma component adsorber 31, a plasma return side flow path 32, a branch flow path 20, a branch pump 21, and a control unit 50.

[0065] The plasma separator 11 has a first space and a second space separated by a membrane. The membrane is porous and separates plasma components and pathogenic substances that are smaller than the pores from blood cells. As a result, the first space becomes a space through which blood cells flow, and the second space becomes a space through which plasma components flow. Blood supplied from the blood removal side flow path 12 is supplied to the first space, and the plasma components and pathogenic substances permeate the membrane and are separated into the second space. The plasma components and pathogenic substances separated into the second space are discharged from the plasma collection flow path 25. Furthermore, the blood from which the plasma has been separated flows out from the first space into the blood return side flow path 13.

[0066] The blood removal side flow path 12 is an example of a first blood flow path, and is provided between the specimen M and the plasma separator 11. By driving a blood pump 14, which is an example of a first pump provided at a midpoint of the blood removal side flow path 12, blood is sent from the specimen M to the first space of the plasma separator 11.

[0067] The blood return side flow path 13 is an example of a second blood flow path, and is provided between the specimen M and the plasma separator 11. By driving a blood pump 14 provided midway along the blood removal side flow path 12, blood containing blood cells from which plasma components and pathological substances have been separated in the plasma separator 11 is sent to the specimen M.

[0068] The circulation flow path 15 is provided as a bypass flow path between the blood removal side flow path 12 and the blood return side flow path 13, and by driving a circulation pump 16, which is an example of a second pump provided at a position midway along the circulation flow path 15, blood containing blood cells from which plasma components and pathological substances have been separated in the plasma separator 11 is circulated from the blood return side flow path 13 to the blood removal side flow path 12.

[0069] The plasma collection flow path 25 is provided between the plasma separator 11 and the plasma component adsorber 31, and by driving a plasma pump 26 provided midway along the plasma collection flow path 25, the plasma components separated from blood containing blood cells in the plasma separator 11 are sent to the plasma component adsorber 31.

[0070] The plasma component adsorber 31 includes a filter that adsorbs pathogenic substances from the delivered plasma components, and discharges the plasma components from which the pathogenic substances have been removed into the plasma return flow path 32.

[0071] The plasma return flow path 32 is provided between the plasma component adsorber 31 and the blood return flow path 13, and is connected to a portion of the blood return flow path 13 downstream of the connection portion with the circulation flow path 15. As a result, the circulation flow path 15 is supplied with blood after the plasma flowing out from the plasma separator 11 has been separated, before being mixed with the plasma components from which pathological substances have been removed and supplied from the plasma return flow path 32. By driving a plasma pump 26 provided midway along the plasma collection flow path 25, the plasma return flow path 32 sends the plasma components from which pathological substances have been removed in the plasma component adsorber 31 to the blood return flow path 13. The plasma components sent to the blood return flow path 13 are mixed with a portion of the blood containing blood cells from which the plasma components have been separated in the plasma separator 11, and are sent to the specimen M.

[0072] The branch flow path 20 branches off from the plasma return flow path 32 and is provided between the plasma component adsorber 31 and the circulation flow path 15. By driving a branch pump 21, which is an example of a third pump provided midway along the branch flow path 20, plasma components from which pathological substances have been removed in the plasma component adsorber 31 are sent to the circulation flow path 15. The plasma components sent to the circulation flow path 15 are mixed with blood containing blood cells sent from the blood return flow path 13 to the circulation flow path 15, and are sent from the blood return flow path 13 to the blood removal flow path 12 via the circulation flow path 15. The branch flow path 20 allows the blood containing blood cells from which plasma components and pathological substances have been separated to merge with the plasma components from which the pathological substances have been removed within the circulation flow path 15. The flow rate of the plasma components from which pathological substances have been removed flowing through the branch flow path 20 can be adjusted by the branch pump 21, and the flow rate of the blood containing blood cells from which plasma components have been separated, flowing from the blood return flow path 13 into the circulation flow path 15, can be adjusted by the circulation pump 16. By arbitrarily adjusting the ratio of the flow rate of plasma components from which pathogenic substances have been removed to the flow rate of blood containing blood cells from which plasma components have been separated, the concentration of blood cell components contained in the circulating blood can be appropriately controlled.

[0073] The control unit 50 is realized by, for example, a hardware processor such as a CPU (Central Processing Unit) executing a program (software). Furthermore, some or all of these components may be realized by hardware (including circuitry) such as an LSI (Large Scale Integration), an ASIC (Application Specific Integrated Circuit), an FPGA (Field-Programmable Gate Array), or a GPU (Graphics Processing Unit), or may be realized by a combination of software and hardware. The program may be stored in advance in the storage unit of the control unit 50, or may be stored on a removable computer-readable recording medium such as a DVD or CD-ROM, and installed in the storage unit of the control unit 50 by inserting the computer-readable recording medium into a drive device.

[0074] The control unit 50 controls the flow rate of blood delivered by driving the pumps 14, 16, 21, and 26, for example, by controlling the driving of the blood pump 14, the circulation pump 16, the branch pump 21, and the plasma pump 26.

[0075] The control unit 50 controls, for example, the drive of the branch pump 21 to control the hematocrit value of the blood in the circulation flow path 15. The control of the drive of the branch pump 21 by the control unit 50 is substantially the same as in Example 1, and by replacing the drainage pump 23 with the plasma pump 26, the flow rate of the branch pump 21 can be calculated.

[0076] The control unit 50 controls, for example, the operation of the circulation pump 16, causing a portion of the blood in the blood return side channel 13 to merge with the circulation channel 15 and then with the blood removal side channel 12. The control unit 50 controls the operation of the branch pump 21 based on, for example, the speed of the circulation pump 16 and the plasma collection rate.

[0077] Next, the operation of the blood purification apparatus 10B of this embodiment will be described.

[0078] In the blood purification apparatus 10B of this embodiment, plasma components from which pathogenic substances have been removed in the plasma component adsorber 31 are sent to the circulation flow path 15 via the branch flow path 20. That is, the plasma components from which pathogenic substances have been removed in the plasma component adsorber 31 are sent directly to the circulation flow path 15. In this case, the plasma components from which pathogenic substances have been removed in the plasma component adsorber 31 are mixed with blood containing blood cells from which plasma components have been separated in the plasma separator 11, which is circulated from the blood return flow path 13 to the circulation flow path 15. The mixed liquid is then circulated to the blood removal flow path 12 via the circulation flow path 15. That is, the mixed liquid does not pass through the branch between the blood return flow path 13 and the circulation flow path 15. Therefore, compared to conventional techniques, the concentration of blood cell components in the circulation flow path 15 can be more appropriately controlled (e.g., the same concentration as that of blood in the blood removal flow path 12). For example, although an excessively high concentration of blood cell components can cause hemolysis, the blood purification apparatus 10 of this embodiment can reduce the risk of unintended hemolysis.

[0079] In particular, in the blood purification device 10B of this embodiment, the operation of the branch pump 21 is controlled so that the hematocrit value of the blood flowing in the circulation flow path 15 becomes the same as the hematocrit value of the blood of the specimen M in the blood removal side flow path 12. Therefore, the concentration of blood cell components contained in the circulating blood is more appropriately controlled.

[0080] The above-described embodiments can also be implemented in the following manner.

[0081] In the second embodiment, the replenishment liquid in the fluid replacement bag 17 is mixed with the plasma components separated in the plasma component separator 27 and sent to the circulation flow path 15 via the branch flow path 20. Alternatively, the plasma components separated in the plasma component separator 27 may be sent to the circulation flow path 15 via the branch flow path 20 without providing the fluid replacement bag 17 and the supply pump 19.

[0082] The above-described embodiments are intended to facilitate understanding of the present invention and are not intended to limit the scope of the present invention. The present invention may be modified or improved without departing from its spirit, and equivalents are also included within the scope of the present invention. In other words, designs modified by those skilled in the art as appropriate are also encompassed within the scope of the present invention as long as they incorporate the characteristics of the present invention. For example, the elements of the embodiments, as well as their arrangement, materials, conditions, shape, size, etc., are not limited to those exemplified and can be modified as appropriate. Furthermore, the elements of the embodiments can be combined to the extent technically possible, and such combinations are also encompassed within the scope of the present invention as long as they incorporate the characteristics of the present invention. [Explanation of symbols]

[0083] 10, 10A, 10B...blood purification device, 11...plasma separator, 12...blood removal side flow path, 13...blood return side flow path, 14...blood pump, 15...circulation flow path, 16...circulation pump, 17...fluid replacement bag, 18...supply flow path, 19...supply pump, 20...branch flow path, 21...branch pump, 22...waste flow path, 23...waste pump, 24...waste tank, 25...plasma collection flow path, 26...plasma pump, 27...plasma component separator, 28...waste flow path, 29...waste pump, 30...waste tank, 31...plasma component adsorption device, 32...plasma return side flow path, 50...control unit, M...sample.

Claims

1. a plasma separator having a first space and a second space separated by a membrane; a first blood flow path that supplies blood from a specimen to the first space of the plasma separator; a second blood flow path that supplies blood from the first space of the plasma separator to the specimen; a first pump that pumps the blood in the first blood flow path from the specimen to the first space of the plasma separator; a circulation flow path that supplies blood from the second blood flow path to the first blood flow path; a second pump that pumps the blood in the circulation flow path from the second blood flow path to the first blood flow path; a supply flow path for supplying plasma and / or replacement fluid to the second blood flow path; a branch flow path that branches off from the supply flow path and supplies the plasma or the replacement fluid from the supply flow path to the circulation flow path; a third pump that sends the plasma or the replacement fluid in the branch flow path to the circulation flow path; a control unit that controls the driving of the third pump and sends a part of the plasma and / or the replacement fluid in the supply flow path to the branch flow path so that the part joins with the circulation flow path; Equipped with the connection point of the supply flow path is located downstream of the connection point of the circulation flow path in the second blood flow path. Blood purification device.

2. a plasma component adsorbent; a plasma collection flow path that supplies plasma from the second space of the plasma separator to the plasma component adsorber, the supply flow path supplies plasma from the plasma component adsorber to the second blood flow path. The blood purification device according to claim 1 .

3. a plasma component separator; a plasma collection flow path for supplying plasma from the second space of the plasma separator to the plasma component separator, 2. The blood purification apparatus according to claim 1, wherein the plasma component separator is connected to the supply flow path and supplies plasma to the supply flow path.

4. a fluid supply bag connected to the supply flow path; The supply flow path supplies plasma and replacement fluid to the second blood flow path. The blood purification device according to claim 3 .

5. Has a fluid replacement bag, The supply flow path supplies replacement fluid from the replacement fluid bag to the second blood flow path. The blood purification device according to claim 1 .

6. the control unit controls the driving of the third pump to control the hematocrit value of the blood in the circulation channel. The blood purification device according to claim 1 .

7. the control unit controls the driving of the second pump to circulate a portion of the blood in the second blood flow path to the circulation flow path and merge it with the first blood flow path. The blood purification device according to claim 1 .

8. The control unit controls the driving of the third pump based on the speed of the second pump. The blood purification device according to claim 7.

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