JP2010253152A - Apheresis donation apparatus, and method for operating the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To give an incentive to a blood donation action by purifying a plasma component by a plasma purifier in retransfusion, and also to appropriately and efficiently purify the plasma component by the plasma purifier, in an apheresis donation apparatus having a single puncture needle. <P>SOLUTION: The apheresis donation apparatus 1 includes: the single puncture needle 10; a centrifugal machine 11 for separating the blood into at least a blood donation component, the plasma component, and a retansfusion component; a blood donation component storage part 12; a first circuit 13 for connecting the puncture needle 10 to the centrifugal machine 11; a second circuit 14 for connecting the centrifugal machine 11 to the blood donation component storage part 12; and a third circuit 15 connected from the centrifugal machine 11 to the first circuit 13. The plasma purifier 20 for purifying the plasma component is connected to the third circuit 15. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a technique for separating a collected blood component, collecting and storing a specific blood donation component, and returning a non-blood donation component that has not been collected.

  Blood donation includes whole blood donation and component donation in which specific components are collected and other components are returned. Since component blood donation requires blood return, a circuit for blood collection (blood removal) and blood return is required. For this reason, in component blood donation, a double needle component blood donation device having a puncture needle for blood collection, a puncture needle for blood return, and a circuit connected to each has been used. By using an apparatus having such a configuration, blood donation has been performed so that the blood flow is basically one-way.

  However, in the case of the double needle, since the puncture is performed at two places such as both arms, the mental burden and the physical burden on the donor are large, which is a factor of mental restraint of blood donation motive.

  In order to eliminate such burdens on donors, lower the hurdles of donor blood donation behavior and blood donation, and to eliminate the complicated work of puncture and circuit installation at the site of blood donation, component blood donation with a single needle is the mainstream nowadays. It has become.

  In the case of a single needle, blood is collected and returned by a single puncture needle, so that a part of the circuit can perform both forward blood flow and reverse blood flow. In a circuit portion common to the forward blood flow and the reverse blood flow, it is necessary to control blood flow by providing both blood collection and blood return functions (see Patent Documents 1, 2, and 3). ).

JP 2004-105581 A Japanese Patent No. 3850429 Japanese Patent No. 3487609

  By the way, the blood donation is based on the behavior of the donor for charity, and there is no direct cost for blood collection. However, in order to ensure the safety of the collected blood and the safety of the donor, all the circuits that are in contact with blood are made disposable (disposable). In addition, the safety of the collected blood is variously verified through various tests and evaluations. As a result, the safe blood that can ultimately be used is substantially expensive.

  The blood products business bears the costs for the safety of these blood and the safety of donors, and there is a need for costs to secure donors while financial incentives are prohibited for donors. It has a business structure that bears these as costs necessary for business continuity.

  Although the blood product business has a business structure that cannot be realized without the actions of the donor from whom the blood is obtained, there is a reality that the donor's blood donation opportunities are decreasing.

  In particular, the population with relatively high awareness of blood donation is shifting to the elderly, and the number of young donors who donate blood due to charity awareness has decreased. It is getting harder to secure.

  In addition, blood providers have secured blood with safety as a top priority, so blood from unhealthy / disease reserves that exceed certain thresholds for blood in blood tests. It is premised on the measures to be discarded.

  After the ban on donation of money, blood companies motivate them to feel a sense of accomplishment by providing physical nutrition drinks or recording them in a blood donation notebook, etc., in order to attract donor donations and incentives We have been approaching donor acquisition such as securing repeaters.

  However, as mentioned above, with the current decline in the population of young people who cause blood donation and the aging / unhealth of the population that causes blood donation, a different approach is necessary to secure blood. It has become.

  Therefore, the present inventors are considering to improve / promote health by providing blood in order to incentivize blood donation behavior. Specifically, for example, a plasma purifier is provided in the blood return circuit, and it is considered that unnecessary substances such as LDL are removed from the plasma component to purify the plasma component and then returned to the donor. However, when a plasma purifier is simply provided in the blood return circuit, in the case of a single puncture needle component blood donation device as described above, for example, a part of the blood collection and blood return circuit is common, so that the plasma purification Blood return components such as blood cell components other than plasma components may enter the vessel. For example, if many blood cell components frequently enter the plasma purifier, the plasma purifier may be clogged or the purification ability may be reduced.

  The present invention has been made in view of such points, and in the component blood donation device of a single puncture needle, the plasma component is purified by a plasma purifier when blood is returned to provide incentive to the blood donation behavior, It is an object of the present invention to appropriately and efficiently purify plasma components with the plasma purifier.

  The invention for achieving the above object is a component blood donation device for performing component blood donation, which is a single puncture needle unit, a centrifuge that separates blood into at least a blood donation component, a plasma component, and a blood return component A blood donation component reservoir that stores the blood donation component, the puncture needle portion and the centrifuge are connected, blood is sent from the puncture needle portion to the centrifuge, and the puncture needle is fed from the centrifuge A first circuit for sending the blood return component to a section, the centrifuge and the blood donation component storage section are connected, and the blood donation component separated by the centrifuge is sent to the blood donation component storage section A second circuit connected to the first circuit from the centrifuge, and a plasma component separated by the centrifuge is returned to the first circuit and returned to the puncture needle unit A circuit, and the third circuit purifies the plasma component. Wherein the plasma purifier that is connected. “Blood donation component” and “plasma component” are those after being separated by a centrifuge and do not necessarily have to be pure. I just need it. The plasma component is preferably in a state in which no blood cell component is mixed therein.

  According to the present invention, the third circuit for returning the plasma component separated by the centrifuge to the first circuit is provided, and the plasma purifier is connected to the third circuit, so that blood donation is performed. By purifying plasma components, it is possible to improve / promote donor health. This gives incentives to blood donation behavior and secures more donors. In addition, in a component blood donation device having a single puncture needle part, it is possible to prevent blood return components such as blood cell components other than plasma components from entering the plasma purifier frequently and in large quantities, so that clogging of the plasma purifier and Reduction in purification capacity is suppressed. As a result, it is possible to appropriately and efficiently purify plasma components by the plasma purifier.

  A plasma component reservoir that temporarily stores the plasma component may be connected to the third circuit.

  The plasma purifier may be disposed closer to the centrifuge than the plasma component reservoir of the third circuit.

  The plasma purifier may be disposed closer to the first circuit than the plasma component reservoir of the third circuit.

  The third circuit may have a branch circuit to which the plasma component reservoir is connected, and the plasma purifier may be connected to the branch circuit.

  A bypass circuit that bypasses the plasma purifier may be connected to the branch circuit.

  The first circuit includes a blood collection circuit for sending blood from the puncture needle unit to the centrifuge and a blood return circuit for sending the blood return component from the centrifuge to the puncture needle unit. You may have.

  The component blood donation apparatus may further include an inflow suppression unit that suppresses the blood return component of the first circuit from flowing into the third circuit.

  The plasma purifier may have a hollow membrane for separating and removing unnecessary substances from plasma components.

  The plasma purifier may have an adsorption member that adsorbs and removes unnecessary substances from plasma components.

  Another aspect of the present invention is a method of operating a component blood donation device for performing component blood donation, wherein the component blood donation device includes a single puncture needle, blood, at least a blood donation component, a plasma component, A centrifuge for separating the blood return component, a blood donation component reservoir for storing the blood donation component, a first circuit connecting the puncture needle unit and the centrifuge, the centrifuge and the blood donation component storage A second circuit that connects the components, a third circuit that is connected from the centrifuge to the first circuit, and a plasma purifier that is connected to the third circuit and purifies plasma components. The blood removed from the puncture needle is sent to the centrifuge through the first circuit, and in the centrifuge, the blood is converted into at least a blood donation component, a plasma component, and a blood return component. Separating the separated blood donation component into the second circuit Through the third circuit, the plasma component is purified by the plasma purifier through the third circuit and returned to the first circuit, and the puncture through the first circuit together with the blood return component The component blood donation device is operated so as to return to the needle portion.

  The component blood donation device further includes a plasma component storage unit that is connected to the third circuit and temporarily stores the plasma component, and before or after purifying the plasma component with the plasma purifier Then, the plasma component may be temporarily stored in the plasma component storage unit, and then returned to the first circuit.

  According to the present invention, the donor's health condition can be improved and promoted by blood donation, so that the blood donation behavior can be motivated and more donors can be secured. In addition, by improving the donor's health condition, the blood condition is improved at the next and subsequent blood donations, and the ratio of blood discarded by the blood operator's examination can be reduced. In addition, in realizing the component blood donation device, blood components such as blood cell components do not frequently and frequently enter the plasma purifier, and the plasma purifier can appropriately and efficiently purify the plasma component. it can.

It is a schematic diagram which shows the outline of a structure of a component blood donation apparatus. It is a schematic diagram which shows the outline of a structure of the component blood donation apparatus which has a plasma component storage part. It is a schematic diagram which shows the outline of a structure of the component blood donation apparatus which changed the position of the plasma component storage part. It is a schematic diagram which shows the outline of a structure of the component blood donation apparatus which connected the plasma component storage part to the branch circuit of the 3rd circuit. It is a schematic diagram which shows the outline of a structure of the component blood donation apparatus which provided the bypass circuit in the branch circuit. It is a schematic diagram which shows the outline of a structure of the component blood donation apparatus which has a plasma component storage part which has a blood collection circuit and a blood return circuit separately. It is a schematic diagram which shows the outline of a structure of the component blood donation apparatus of a comparative example. It is a graph which shows the result of the pressure transition obtained by experiment.

  Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings. FIG. 1 is a schematic diagram showing an outline of a configuration of a component blood donation apparatus 1 according to the present embodiment. In addition, in this specification and drawing, about the component which has the substantially same function structure, duplication description is abbreviate | omitted by attaching | subjecting the same code | symbol.

  The component blood donation device 1 includes a single puncture needle unit 10, a centrifuge 11 that separates blood into at least a blood donation component, a plasma component, and a blood return component, and a blood donation component storage unit 12 that stores the blood donation component. The first circuit for connecting the puncture needle unit 10 and the centrifuge 11, sending blood from the puncture needle unit 10 to the centrifuge 11, and sending the blood return component from the centrifuge 11 to the puncture needle unit 10. 13, a second circuit 14 for connecting the centrifuge 11 and the blood donation component storage unit 12 to send the blood donation component separated by the centrifuge 11 to the blood donation component storage unit 12, and the centrifuge 11 The third circuit 15 is connected in the middle of the first circuit 13 and returns the plasma component separated by the centrifuge 11 to the first circuit 13.

  A plasma purifier 20 that purifies plasma components is connected to the third circuit 15. The plasma purifier 20 uses a module having a hollow membrane for separating and removing unnecessary substances from plasma components, or a module having an adsorbing member for adsorbing and removing unnecessary substances from plasma components. The plasma purifier 20 having a hollow membrane used size filtration that allows plasma components to pass through a hollow membrane cross section such as a hollow fiber having fine pores in the cross section and sifts according to the size of the molecule. Is. The plasma purifier 20 having an adsorbing member is, for example, a substance that adsorbs an unnecessary substance in a plasma component by bringing the plasma into contact with a carrier labeled with a specific substance, or a substance that adsorbs the plasma itself with the carrier itself. For example, a module filled with porous beads as an adsorbing member.

  For example, the first circuit 13 and the third circuit 15 are connected to pumps P <b> 1 and P <b> 2 for feeding the respective circuits.

  The connection part A between the first circuit 13 and the third circuit 15 is provided with a flow path switching valve 21 such as a three-way cock as an inflow suppressing means. The flow path switching valve 21 allows the flow from the puncture needle 10 at the time of blood collection only to the centrifuge 11 side, and the puncture through both the first circuit 13 and the third circuit 15 from the centrifuge 11 at the time of blood return. Flow to the needle 10 side, flow from the centrifuge 11 to the puncture needle 10 side only when returning blood, and puncture from the centrifuge 11 to return to the third circuit 15 when returning blood A flow or the like only on the needle portion 10 side can be selectively realized. Further, the flow path switching valve 21 can suppress the blood return component of the first circuit 13 from flowing into the third circuit 15 side at the connection portion A.

  The component blood donation apparatus 1 includes a control unit 30 that controls operations of the centrifuge 11, the pumps P1 and P2, the flow path switching valve 21, and the like. The control unit 30 includes, for example, a computer, executes a program recorded in the memory, and controls the operation of the centrifuge 11, the pumps P1, P2, the flow path switching valve 21, and the like, thereby controlling the component blood donation device 1 It can be operated.

  In addition, as a material of the said puncture needle part 10, stainless steel or a nickel titanium alloy etc. are illustrated. The materials of the first circuit 13, the second circuit 14, and the third circuit 15 are polyvinyl chloride, polyethylene, polypropylene, polyester such as PET and PBT, ethylene-vinyl acetate copolymer, polyurethane, and polyester elastomer. And thermoplastic elastomers such as styrene-butadiene-styrene copolymer, etc., among which polyvinyl chloride is particularly preferable. This is because, if each tube is made of polyvinyl chloride, it is easy to handle because sufficient flexibility and flexibility are obtained.

  The blood donation component storage unit 12 stores a blood donation component to be provided to the blood center, and a bag is suitably used for the blood donation component storage unit 12. As the material of the blood donation component reservoir 12, a polyolefin, that is, a polymer obtained by polymerizing or copolymerizing olefins or diolefins such as ethylene, propylene, butadiene, and isoprene can be used. For example, polyethylene, polypropylene, ethylene-vinyl acetate Examples thereof include a copolymer (EVA), a polymer blend of EVA and various thermoplastic elastomers, or any combination thereof. Furthermore, polyesters such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), poly-1,4-cyclohexanedimethyl terephthalate (PCHT), and polyvinylidene chloride can also be used.

  Examples of the hollow membrane of the plasma purifier 20 include homogeneous micropores made of ethylene vinyl alcohol copolymer, polysulfone, polyethersulfone, polyester, polyamide, polyacrylonitrile, cellulose derivatives such as cellulose diacetate, polyolefin, etc. Specific examples of the products include Cascade Flow EC (Asahi Kasei Kuraray Medical, Japan), CHAGALL (Fresenius, Germany), ALBUSAVE (DIDECO, Italy), and the like. Examples of carriers used for adsorption removal of the plasma purifier 20 include sepharose, polyvinyl alcohol, cellulose, ethylene vinyl alcohol copolymer, activated carbon, and the like, and examples of specific substances include tryptophan, protein A, Phenylalanine, dextran sulfate, antibody, antigen, quaternary ammonium, and the like can be mentioned. Specific products include Imsorba TR (Asahi Kasei Kuraray Medical, Japan), Liposorba (Kaneka, Japan), TheraSorb (Miltenyi Biotec, Germany).

  Next, operation | movement of the component blood donation apparatus 1 comprised as mentioned above is demonstrated. When the puncture needle unit 10 is punctured by the donor during component blood donation, blood collected from the puncture needle unit 10 is first sent to the centrifuge 11 through the first circuit 13 by the pump P1 shown in FIG. Next, in the centrifuge 11, the blood is separated into blood-returning components mainly composed of, for example, a platelet component as a blood donation component, a plasma component, and other blood cell components. The blood return component is the remaining blood component after the blood donation component and the plasma component are removed by the centrifuge 11, and the blood return component includes plasma that has not been separated by the centrifuge 11, Blood cells of the same type as the component that performs blood donation after being sufficiently stored in the blood donation component storage unit 12 may also be included.

  The platelet component separated by the centrifuge 11 is sent to the blood donation component storage unit 12 through the second circuit 14 and stored. The blood return component is returned to the puncture needle unit 10 through the first circuit 13 by, for example, the pump P1. The plasma component is returned from the connection A to the first circuit 13 through the third circuit 15. At this time, the plasma component passes through the plasma purifier 20 and is an unnecessary substance such as a component that increases with aging, a substance that is supposed to induce metabolic syndrome, specifically, active oxygen, LDL cholesterol, Urea nitrogen, neutral fat, etc. are removed and purified.

  The blood return component and the purified plasma component merge at the connection portion A, are sent to the puncture needle portion 10 through the first circuit 13, and are returned to the donor. In addition, operation | movement of these component blood donation apparatuses 1 is implement | achieved when the control part 30 controls pump P1, P2, the centrifuge 11, the flow-path switching valve 21, etc. FIG.

  According to the above embodiment, the third circuit 15 for returning the plasma component separated by the centrifuge 11 to the first circuit 13 is provided, and the plasma purifier 20 is provided in the third circuit 15. Since it is connected, it is possible to purify plasma components by donating blood and to improve and promote donor health. This gives incentives to blood donation behavior and secures more donors. Further, in the component blood donation device 1 having the single puncture needle portion 10, it is possible to prevent blood return components including blood cell components and the like from entering the plasma purifier 20 frequently and in large quantities. The decrease in the purification capacity can be suppressed, and as a result, the plasma components can be purified appropriately and efficiently by the plasma purifier 20.

  Since the connection part A between the first circuit 13 and the third circuit 15 is provided with a flow path switching valve 21 that suppresses the blood return component of the first circuit 13 from flowing into the third circuit 15. The blood return component can be prevented from entering the third circuit 15 from the connection portion A and entering the plasma purifier 20. This also maintains the purification efficiency of the plasma purifier 20.

  When the plasma purifier 20 has a hollow membrane that separates and removes unnecessary substances from plasma components, unnecessary substances are removed by the membrane pores. Substances that do not pass through membrane pores such as immune complexes can be removed. Further, when the plasma purifier 20 has an adsorbing member that adsorbs and removes unnecessary substances from plasma components, by using an adsorbent corresponding to the adsorption target to be removed, the target to be removed by plasma purification is selected as a donor. Can meet your needs. In particular, when focusing on removing LDL, a liposorber (Kaneka), which is an adsorbent for LDL, can be used.

  In the component blood donation device 1 of the above embodiment, for example, as shown in FIG. 2, a plasma component storage unit 40 that temporarily stores plasma components may be connected to the third circuit 15. In such a case, for example, the plasma purifier 20 may be disposed closer to the first circuit 13 than the plasma component reservoir 40. In this case, the plasma component separated by the centrifuge 11 is sent to the plasma component storage unit 40 through the third circuit 15 and temporarily stored. Thereafter, when blood is returned, the plasma components in the plasma component reservoir 40 are purified by the plasma purifier 20 through the third circuit 15 and then returned to the first circuit 13 from the connection portion A, toward the puncture needle 10 side. Sent. Other operations are the same as those in the above embodiment, for example.

  According to this embodiment, for example, plasma components from the centrifuge 11 can be temporarily stored at the time of blood collection, so that separation of platelet components and plasma components by the centrifuge 11 and storage of platelet components can be further performed. Can be performed continuously for a long time. In addition, since the plasma purifier 20 is closer to the first circuit 13 than the plasma component reservoir 40, it is easy to control the plasma temporarily stored in the plasma component reservoir 40 continuously to the plasma purifier 20, Changes in the amount of plasma (flow rate, flow rate) flowing into the plasma purifier 20 can be reduced.

  In the above embodiment, as shown in FIG. 3, the plasma purifier 20 may be arranged closer to the centrifuge 11 than the plasma component reservoir 40 of the third circuit 15. In such a case, the plasma component separated by the centrifuge 11 is purified by the plasma purifier 20 through the third circuit 15, and then sent to the plasma component storage unit 40 and temporarily stored. Thereafter, when returning blood, the plasma components in the plasma component storage unit 40 are returned from the connection unit A to the first circuit 13 through the third circuit 15 and sent to the puncture needle unit 10 side. Other operations are the same as those in the above embodiment, for example.

  According to this embodiment, the plasma purifier 20 is closer to the centrifuge 11 than the plasma component reservoir 40 and can remove unnecessary substances before temporarily storing the plasma, so the plasma component reservoir 40 In this case, it is possible to suppress precipitation such as acne that may be precipitated when the plasma is primarily stored.

  In the above embodiment, the plasma component reservoir 40 is directly connected to the main circuit of the third circuit 15. However, for example, as shown in FIG. 4, the third circuit 15 is connected to the plasma component reservoir 40. The plasma purifier 20 may be connected to the branch circuit 50. The branch circuit 50 is a single line and branches from the main circuit 51 of the third circuit 15. For example, a flow path switching valve 52 is provided at a connection portion B between the branch circuit 50 and the main circuit 51. In such a case, the plasma component separated by the centrifuge 11 is purified by the plasma purifier 20 through the main circuit 51 and the branch circuit 50 of the third circuit 15 and then sent to the plasma component storage unit 40 and temporarily. Stored. Thereafter, when returning blood, for example, the plasma component in the plasma component reservoir 40 is purified again by the plasma purifier 20 through the branch circuit 50, and then from the connection A to the first circuit through the main circuit 51 of the third circuit 15. Return to 13. Other operations are the same as those in the above embodiment, for example.

  According to this embodiment, when the plasma purifier 20 is clogged beyond the plasma purification capacity of the plasma purifier 20, the first without passing through the plasma purifier 20 and the plasma component reservoir 40. The circuit 13 can be controlled to return plasma.

  In the embodiment, as shown in FIG. 5, a bypass circuit 60 that bypasses the plasma purifier 20 may be connected to the branch circuit 50. For example, a flow path switching valve 61 is provided at a connection portion between the branch circuit 50 and the bypass circuit 60. In such a case, for example, the plasma component passes through the plasma purifier 20 either when it is sent from the centrifuge 11 to the plasma component reservoir 40 or when it is returned from the plasma component reservoir 40 to the first circuit 13 side. And purified. The plasma component passes through the bypass circuit 60 when it is not purified by the plasma purifier 20. Other operations are the same as those in the above embodiment, for example. By doing so, for example, the plasma purifier 20 that purifies plasma only in one direction without performing plasma purification in both directions can be used.

  The first circuit 13 of the component blood donation apparatus 1 in the above embodiment includes, for example, a blood collection circuit 70 for sending blood from the puncture needle unit 10 to the centrifuge 11 and a centrifuge 11 as shown in FIG. A blood return circuit 71 for sending a blood return component to the puncture needle unit 10 may be provided separately. The blood return circuit 71 is connected to the connection part A from the centrifuge 11, for example. Further, for example, a blood return component storage unit 72 is connected to the blood return circuit 71. In such a case, for example, at the time of blood collection, blood collected from the puncture needle unit 10 is sent to the centrifuge 11 through the blood collection circuit 70 of the first circuit 13. The blood return component separated by the centrifuge 11 is sent to the blood return component storage unit 72 through the blood return circuit 71 and temporarily stored. Thereafter, the blood return component is sent from the blood return component storage unit 72 to the puncture needle unit 10 through the blood return circuit 71 at the time of blood return. Other operations are the same as those in the above embodiment, for example. Further, the blood return component storage unit 72 may be connected via a branch circuit as in the case of the plasma component storage unit 40 without being directly connected to the blood return circuit 71.

  The preferred embodiments of the present invention have been described above with reference to the accompanying drawings, but the present invention is not limited to such examples. It will be apparent to those skilled in the art that various changes or modifications can be made within the scope of the ideas described in the claims, and these are naturally within the technical scope of the present invention. It is understood that it belongs. For example, the circuit configuration of the component blood donation device 1 described in the above embodiment may have other configurations as long as it has substantially the same function. The blood donation component is not limited to the platelet component, and may be other components such as white blood cells and red blood cells.

  Examples are described below. The examples are not to be construed as limiting the claims.

Example 1
In Example 1, the experiment was performed using the component blood donation apparatus 1 having the same configuration as that in FIG. The said component blood donation apparatus 1 was manufactured using ALYX (made by Fenwal). ALYX is a component blood donation device having a single puncture needle (single needle), and includes a first circuit 13 that flows into the centrifuge 11, a centrifuge 11, and a first circuit from the centrifuge 11. 13 has a third circuit 15 that does not share a circuit portion, a plasma component reservoir 40 connected to the third circuit 15, a second circuit 14, and a blood donation component reservoir 12. To this, a three-way cock 21 as a flow path switching valve and a plasma purifier 20 (membrane type plasma component separator: Cascadeflo EC50W, Asahi Kasei Kuraray Medical Co., Ltd.) were connected to manufacture a component blood donation device 1. Further, a pressure gauge (COPAL ELECTRONICS) was connected to the third circuit 15 in order to measure the pressure transition during blood return.

  Using the above component blood donation device 1, ACD-A solution (composition: sodium citrate 22.0 g / L, citric acid 8.0 g / L, at a rate of 210 mL as an anticoagulant to 1.39 L of blood from in-house volunteers An operation of separating and collecting platelet components from 1.6 L of whole blood prepared by adding 22.0 g / L of glucose) was performed. When collecting blood into the centrifuge 11, the three-way cock 21 is operated so that blood does not flow through the plasma purifier 20, and when returning blood, plasma flows through the plasma purifier 20. The three-way cock 21 was operated. The pressure transition during blood return processing and the measurement of LDL cholesterol concentration during blood return were performed. LDL cholesterol concentration was measured by SRL after serum separation of the returned blood. The removal rate of LDL cholesterol was calculated by dividing the LDL cholesterol concentration after returning blood by the LDL cholesterol concentration of the original blood.

(Example 2)
An experiment was conducted using an LDL adsorber (Liposorber (Kaneka Corporation)) as the plasma purifier 20. The apparatus was the same as in Example 1 except for the plasma purifier 20, and the same measurement was performed.

(Example 3)
In Example 3, the same experiment as in Example 1 was performed using the component blood donation device 1 having the same configuration as in FIG.

Example 4
In Example 4, the same experiment as in Example 2 was performed using the component blood donation device 1 having the same configuration as in FIG.

(Example 5)
In Example 5, the same experiment as in Example 1 was performed using the component blood donation device 1 having the same configuration as in FIG.

(Comparative Example 1)
In Comparative Example 1, the same experiment as in Example 1 was performed using a component blood donation device that does not have a dedicated circuit for returning plasma components from the centrifuge to the puncture needle. Specifically, for example, as shown in FIG. 7, the component blood donation device 100 includes a first circuit 101 that connects a single puncture needle unit 10 and a centrifuge 11, and the first circuit 101 includes A plasma purifier 20 is connected. A bypass circuit 102 that bypasses the plasma purifier 20 is connected to the first circuit 101. The centrifuge 11 is connected to a second circuit 103 that communicates with the blood donation component reservoir 12.

  In the component blood donation device 100, blood is sent from the puncture needle unit 10 to the centrifuge 11 through the bypass circuit 102 of the first circuit 101 at the time of blood collection. The platelet component separated by the centrifuge 11 is sent to and stored in the blood donation component storage unit 12. Thereafter, when returning blood, plasma components other than platelet components are sent from the centrifuge 11 to the puncture needle unit 10 through the plasma purifier 20, and blood return components including blood cell components are transferred from the centrifuge 11 to the puncture needle unit. 10 through the bypass circuit 102.

(Comparative Example 2)
An experiment was conducted using an LDL adsorber (Liposorber (Kaneka Corporation)) as the plasma purifier 20. The apparatus was the same as that in Comparative Example 1 except for the plasma purifier 20, and the same measurement was performed.

  The result of the pressure transition obtained in the above experiment is shown in FIG. In all of Examples 1 to 5, the blood pressure of 1.6 L did not exceed the allowable pressure resistance of the plasma purifier 20. On the other hand, in Comparative Examples 1 and 2, blood cell components remaining in the circuit were introduced into the plasma purifier 20, and an increase in pressure was observed from the start of plasma processing by the plasma purifier 20. In Comparative Example 1, the pressure resistance of the plasma purifier (Cascadeflo EC50W) is 66.6 kPa or more at the time of 400 ml blood treatment, and blood treatment beyond that cannot be performed. In Comparative Example 2, the plasma purifier (at 200 ml blood treatment) The allowable pressure resistance of Liposorber) was 13.3 kPa or more, and blood treatment beyond that could not be performed.

  Next, LDL cholesterol removal rate is shown in Table 1. In Examples 1-5, almost all LDL cholesterol in 1.6 L of blood can be removed, whereas in Comparative Examples 1 and 2, the amount of blood treatment decreases with increasing pressure, so that sufficient removal is possible. There wasn't.

  In the component blood donation device of a single puncture needle, the present invention purifies the plasma component with the plasma purifier when returning blood, gives incentive to the blood donation behavior, and appropriately purifies the plasma component with the plasma purifier And it is useful when performing efficiently.

DESCRIPTION OF SYMBOLS 1 Component blood donation apparatus 10 Puncture needle part 11 Centrifuge 12 Blood donation component storage part 13 1st circuit 14 2nd circuit 15 3rd circuit 20 Plasma purifier

Claims (12)

A component blood donation device for performing component blood donation,
A single puncture needle,
A centrifuge that separates blood into at least a blood donation component, a plasma component, and a blood return component;
A blood donation component reservoir for storing the blood donation component;
A first circuit for connecting the puncture needle unit and the centrifuge, sending blood from the puncture needle unit to the centrifuge, and sending the blood return component from the centrifuge to the puncture needle unit When,
A second circuit for connecting the centrifuge and the blood donation component reservoir and sending the blood donation component separated by the centrifuge to the blood donation component reservoir;
A third circuit connected to the first circuit from the centrifuge and returning the plasma component separated by the centrifuge to the first circuit and back to the puncture needle unit;
A component blood donating apparatus, wherein a plasma purifier for purifying the plasma component is connected to the third circuit.   The component blood donation device according to claim 1, wherein a plasma component storage unit that temporarily stores the plasma component is connected to the third circuit.   The component blood donation device according to claim 2, wherein the plasma purifier is arranged on the centrifuge side with respect to the plasma component reservoir of the third circuit.   The component blood donation device according to claim 2, wherein the plasma purifier is disposed closer to the first circuit than the plasma component reservoir of the third circuit.   The component blood donating apparatus according to claim 2, wherein the third circuit has a branch circuit that connects the plasma component reservoir, and the plasma purifier is connected to the branch circuit.   The component blood donating device according to claim 5, wherein a bypass circuit that bypasses the plasma purifier is connected to the branch circuit.   The first circuit includes a blood collection circuit for sending blood from the puncture needle unit to the centrifuge and a blood return circuit for sending the blood return component from the centrifuge to the puncture needle unit. It has, The component blood donation apparatus in any one of Claims 1-6 characterized by the above-mentioned.   The component blood donation device according to any one of claims 1 to 7, further comprising an inflow suppression unit that suppresses the blood return component of the first circuit from flowing into the third circuit. .   The component blood donating device according to any one of claims 1 to 8, wherein the plasma purifier has a hollow membrane for separating and removing unnecessary substances from plasma components.   The component blood donating device according to any one of claims 1 to 8, wherein the plasma purifier has an adsorbing member that adsorbs and removes unnecessary substances from plasma components. An operation method of a component blood donation device for performing component blood donation,
The component blood donation device is:
A single puncture needle,
A centrifuge that separates blood into at least a blood donation component, a plasma component, and a blood return component;
A blood donation component reservoir for storing the blood donation component;
A first circuit connecting the puncture needle unit and the centrifuge;
A second circuit connecting the centrifuge and the blood donation component reservoir;
A third circuit connected from the centrifuge to the first circuit;
A plasma purifier connected to the third circuit for purifying plasma components,
Blood collected from the puncture needle portion is sent to the centrifuge through the first circuit, and in the centrifuge, the blood is separated into at least a blood donation component, a plasma component, and a blood return component and separated. The blood donation component is stored in the blood donation component reservoir through the second circuit, the plasma component is purified by the plasma purifier through the third circuit and returned to the first circuit, and together with the blood return component, The method for operating a component blood donation device, wherein the component blood donation device is operated so as to return to the puncture needle portion through a first circuit. The component blood donation device is:
A plasma component reservoir connected to the third circuit for temporarily storing the plasma component;
The plasma component is temporarily stored in the plasma component storage unit before or after the plasma component is purified by the plasma purifier, and then returned to the first circuit. The operating method of the component blood donation apparatus described in 1.

Images