JPH06227993A - Device for preparing blood preparation - Google Patents

Abstract

PURPOSE:To obtain the subject device capable of producing various kinds of blood preparations by simple operation, comprising a blood bag connecting means, a blood storing means, a means for separating blood components by a membrane, a blood cell recovering means, a medicine solution adding means, a transporting means and a means for controlling addition of the medicine solution and transportation. CONSTITUTION:In a blood preparing making device 1 for separating components from blood and producing various blood preparations, a connecting means 20 to be sterilely joined is coupled to a blood bag 10 having precollected blood, the blood in the blood bag 10 is transported to a blood storing means 30 and a medicine solution is added to the blood storing means by a medicine solution adding means 60. Then, the blood is sent from the blood storing means 30 to a separating means 40 by a membrane and separated into a blood cell component and a liquid component. The liquid component is stored in a liquid component storing means 50, the blood cell component is recovered by the blood cell recovering means (the blood bag) 10 and a transporting means 70 for sending the components and the medicine solution adding means 60 for feeding the medicine solution to the blood storing means 30 are regulated by a controlling means 80 to produce various blood preparations by simple operations.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood product preparation device for separating various components from blood and preparing various kinds of blood products.

[0002]

2. Description of the Related Art Conventionally, when various blood products such as red blood cell concentrate, washed red blood cell fluid, leukocyte-removed red blood cell fluid, thawed red blood cell fluid, concentrated platelets, and platelet-rich plasma are prepared from blood collected by donating blood. Has been performed by separating a liquid component (plasma) and a blood cell component in blood by centrifuging a blood bag.

As a method for separating blood into a liquid component and a blood cell component by a method other than the centrifugation method, there is a method using a membrane plasma separator. Japanese Unexamined Patent Publication No. 63-226364 discloses an apparatus based on the drop method for collecting plasma. Japanese Unexamined Patent Publication No. 63-235866 discloses an apparatus for collecting plasma by pressurizing and depressurizing a blood collecting bag. Japanese Patent Application Laid-Open No. 2-98365 also discloses a device for collecting plasma by pressurizing and depressurizing a blood collecting bag.

[0004]

However, in the case of performing the separation by the above-mentioned centrifugation method, although there is an advantage that a large amount of blood can be centrifuged at one time, the step of separating blood after centrifugation is It has the drawback of becoming complicated. That is, the blood cells and plasma separated after centrifugation must be manually separated, the operation is complicated, and blood cells may be mixed in the separated plasma. Also, for some formulations it is difficult to keep the circuit in a completely closed system during the preparation process, which can lead to contamination of the formulation.

Further, when the separation membrane is used, the above-mentioned drawbacks are solved, but the apparatus of the above publication can prepare only the concentrated red blood cell liquid and the raw material plasma, and cannot prepare other red blood cell preparations. . Further, in this device, the blood collection needle is also integrated, and the whole plasma collection kit is brought to the blood collection site, which is inefficient and the operability during blood collection is considered to be poor.

The present invention has been made in view of the above problems, and an object of the present invention is to provide a blood product preparation device which is easy to operate and can prepare various blood products.

[0007]

In order to achieve such an object, the blood product preparation apparatus of the present invention has a connecting means capable of aseptically connecting to a blood bag that has been previously drawn, and temporarily stores blood. Blood storing means, membrane separating means for separating blood into blood cells and liquid components by a membrane, liquid component storing means for storing the separated liquid components, blood cell collecting means for collecting the separated blood cells, and collection of the blood bag Solution adding means for adding a drug solution to the collected blood, a transfer means for transferring at least one of the blood, the separated liquid component and blood cell component, and a control means for controlling the drug solution adding means and the transfer means. The control means transfers the blood in the blood bag connected by the connecting means to the blood storing means, and adds the chemical liquid to the blood storing means by the chemical liquid adding means, and the blood storing means. The liquid component is separated into a liquid component and a blood cell component, the liquid component is stored in the liquid component storage device, and the blood cell component is collected in the blood cell collection device by performing the control once or more times. To be achieved.

[0008]

EXAMPLE FIG. 1 is an overall view showing an example of a blood product preparing apparatus of the present invention.

FIG. 2 is a circuit diagram showing the disposable portion of FIG.

As shown in FIG. 1, the blood product preparation device 1 of the present invention comprises a connecting means 20 capable of aseptically connecting to a blood bag 10 in which blood has been collected in advance, and a blood storing means 30 for temporarily storing blood. A membrane separating means 40 for separating blood into blood cells and a liquid component by a membrane, a liquid component storing means 50 for storing the separated liquid component, a blood cell collecting means 10 for collecting the separated blood cells, and a blood bag 10 are collected. Drug adding means 60 for adding a drug solution to blood, transfer means 70 for transferring blood, at least one of separated liquid components and blood cell components, drug solution adding means 60 and transfer means 70
And a control means 80 for controlling
The blood in the blood bag 10 connected by the connecting means 20 is transferred to the blood storing means 30, the chemical liquid is added to the blood storing means 30 by the chemical liquid adding means 60, and the blood is transferred from the blood storing means 30 to the membrane separating means 40. It is characterized in that the liquid component and the blood cell component are separated, the liquid component is stored in the liquid component storage means 50, and the blood cell component is collected in the blood cell collection means 10 once or more.

As shown in FIG. 2, a disposable part in which blood moves or is stored and a disposable part are set, and a device for moving internal blood by applying physical force from the outside. It can be divided into parts.

The disposable portion is a blood bag 1.
0, blood storing means 30, membrane separating means 40, liquid component storing means 50, blood cell collecting means 10, drug solution adding means 60, and tubes connecting these. Although the blood cell collecting means 10 has a circuit shared with the blood bag 10 in FIG. 2, a blood cell collecting means may be provided separately from the blood bag 10. Further, the function of the blood cell collecting means is changed to the blood storing means 3
It is also possible to use 0 in combination.

The structure of the disposable portion will be described in further detail. A blood (blood collection) bag 10, a blood collection tube 12 extending therefrom, and a connection / disconnection using a connection means 20 capable of aseptically connecting to the blood collection tube 12. And a tube 14. Furthermore, the connection tube 14 has a blood cell component tube 16 communicating at its end with a membrane separation means, that is, a blood cell component tube of the membrane type separator 40, and a blood storage means.
That is, the bypass tube 18 that joins the blood storage tube 17 that connects the blood storage bag 30 and the membrane separator 40.
Consists of. Further, in the membrane separator 40, the liquid component outlet is in communication with the liquid component storing means, that is, the liquid component bag 50 by the liquid component tube 19. A blood storage tube 17 and a drug solution tube 15 communicating with the drug solution adding means 60 from the middle are provided.

As the blood bag 10, the blood storage bag 30, and the liquid component bag 50, soft PVC soft bags are preferably used. The liquid component bag 50 is preferably a polyolefin bag when, for example, plasma is stored depending on the purpose of use. This is to reduce damage caused by freezing and thawing operations.

As the liquid medicine adding means, that is, the liquid medicine bag 60, the one in which the liquid medicine is sealed in advance is used. The drug solution varies depending on the purpose of use, but is physiological saline for washing red blood cells / platelets or for thawing red blood cells, for example.
Other examples include red blood cell preservation solutions.

The membrane separator 40 has a function of separating blood cell components and other components according to the pore size of the membrane. The membrane may be a flat membrane or a hollow fiber. As the membrane material, polypropylene is given as an example.

Next, as the device portion, the connecting means 20
And a transfer means 70 for transferring at least one of blood, the separated liquid component and blood cell component, a drug solution adding means 60 and a control means 80 for controlling the transfer means 70. Further, a closure opening means for closing and opening each tube to control the movement of the content liquid is provided.

In the connecting means 20, the connecting tube 14 and the blood collecting tube 12 whose both ends are sealed and closed are placed so as to be parallel to each other in opposite directions, and the tube is pressed with a clamp to close the tube material. The connection tube 1 is shifted in the direction orthogonal to the tube axis direction while melting and cutting with a heating cutting blade heated to a melting temperature or higher.
4 and the blood collection tube 12 can be melt-connected.

The connecting means 20 will be described with reference to FIGS. The connecting means 20 is composed of a first clamp 202, a second clamp 203 and a heating cutting blade 206. FIG. 3 shows a state in which the blood collection tube 12 and the connection tube 14 are placed in opposite directions and in parallel, and the respective tubes are pressed by a clamp to be closed. The distance between the first and second clamps 202 and 203 is actually short, but the distance is increased for clarity in the drawing. The heating cutting blade 206 melts and cuts the tubes 12 and 14 in a state of being heated from below the gap between both clamps to a temperature higher than the melting temperature of the tubes (FIG. 4). Then, while maintaining the heating temperature, the second clamp 203 moves in a direction orthogonal to the tube axis direction (direction of arrow in FIG. 5) and moves to a position where the blood collection tube 12 and the connection tube 14 are aligned. After that, the heating cutting blade 206 descends downward (in the direction of the arrow in FIG. 6), and the blood collection tube 12 and the connection tube 14 are melted and connected. FIG. 6 shows the clamps 202, 2
03 is open. Since the tubes 12 and 14 are pressed and completely closed by the ends of the clamps 202 and 203 facing each other (the side between the clamps), the tubes 12 and 14 are melt-cut by the heating cutting blade 206 to melt the surface of the heating cutting blade 206. Even if it is moved, the liquid content (blood, etc.) does not leak out, and the connection guarantees sterility.

When cutting the tubes 12 and 14 connected by the connecting means 20, it is possible to reverse the above steps. That is, the clamp 20
2, the tubes 12 and 14 connected to the 203 are set, melted and cut by the heating cutting blade 206, the clamp 203 moves in the direction orthogonal to the tube axial direction, and the heating cutting blade 206 goes down. This means that the tubes 12 and 14 were cut with the ends closed. Also, a commonly used known tube sealer may be separately provided or used for cutting.

Further, since the tubes 12 and 14 connected by the connecting means are in a state of being pressed and closed at the connecting portion, a device may be provided to squeeze the portion from both sides to communicate the inside.

As the transfer means 70, as shown in FIG. 1, the blood storage bag 30 is pressurized or depressurized to transfer blood into the blood storage bag 30 or move blood from the blood storage bag 30. A typical example is a roller pump system in which a tube is squeezed by rollers to move the content liquid.

The pressurizing / depressurizing method will be described with reference to FIG.
The blood storage bag 30 is placed on the tray 74 of the blood storage container storage 72 of the transfer means 70. Below the tray 74, swinging means 78 for swinging the blood storage bag 30 is provided via the weight detecting means 76. The weight detection means 76 is for measuring the weight of the blood storage bag 30 by pressurization and depressurization. Further, the pressurizing / depressurizing means 75 for pressurizing / depressurizing the inside of the blood storage container accommodating portion 72 is kept at a predetermined pressure by the control means by the pressure detected by the pressure detecting portion 73.

FIG. 7 is a reference circuit diagram of a roller pump system. The blood storage bag 30 (which is also a blood collection bag) has tubes connected by two connecting means. A roller pump 701 is installed in the tube 17 extending from the blood storage bag 30 to the membrane separator 40. The separator 40 separates the liquid component and the blood cell component, and the liquid component reaches the liquid component bag 50 through the tube 19. On the other hand, the blood cell component is returned to the blood storage bag 30 via the tube 16. The tube 15 communicates with the middle of the tube 16 so that the liquid medicine of the liquid medicine bag 60 merges. The tube 15 is also provided with a roller pump 702. By rotating these two roller pumps 701 and 702 in the direction of the arrow shown in the figure, the flow of the content liquid (particularly blood cells) is circulated in the order of blood storage bag 30 → tube 17 → separator 40 → tube 16 → blood storage bag 30. Then, the treatment can be continuously performed and the efficiency is improved. Since the purpose is to prepare a blood product, it is not necessary to detect air bubbles, internal pressure, etc. precisely regardless of the human body.

The block opening means is the circuit example of FIG.
The blockage opening means 91 is provided in the tube 16 at the blood cell outlet portion of the separator 40. Further, in the middle of the liquid component bag 50, the tube 19, the bypass tube 18, and the drug solution tube 15 are provided with the closure opening means 93, 95, 97, respectively.

The liquid component bag 50 is provided with a weight detector 52 for measuring the amount of the component. Although not shown, the blood bag 10 may be provided with a weight detection unit.

The control means 80 is electrically connected to the respective closure opening means, the pressure detecting section 73, the pressurizing / depressurizing means 75, the weight detecting section 76, the weight detecting section 52, and the connecting means 20. Control the flow.

Actually, washed red blood cells were prepared using the apparatus shown in FIG. A negative pressure of −180 mmHg is applied to the blood storage bag 30 by the decompression / pressurizing means 75 to transfer 120 g of the concentrated red blood cells of the blood collection bag 10 previously collected to the blood storage bag 30, and 110 g of physiological saline is added thereto and shaken. It is swung by the moving means 78 to mix and dilute well. Positive and negative pressure of 100 mmHg is applied to the blood storage bag for decompression and pressurization 75
The diluted concentrated red blood cell liquid is introduced into the membrane separator 40 and separated into a liquid component and a blood cell component. The blood cell component separated to the blood collection bag 10 side is again collected in the blood storage bag 30, and the same dilution / separation work is performed 3
Repeat times. Finally, by injecting 110 g of physiological saline into the blood collection bag 10 side via the membrane separator 40,
Washed red blood cells were prepared.

As a result, washed red blood cells with a red blood cell recovery rate of 95%, a plasma protein removal rate of 99% and a free hemoglobin amount of 13 mg / dl could be obtained. The working time was 20 minutes, which was less than half the time required for the conventional centrifugation method.

[0030]

The operation of the blood preparation device of the present invention will be described with reference to the example of washing red blood cells.

As shown in FIG. 1, the blood collection bag 10 containing concentrated red blood cells is aseptically connected to the tube 12 and the tube 14 by the connecting means 20.

By applying a predetermined negative pressure to the blood storage bag 30 by the depressurizing / pressurizing means 75, the concentrated red blood cells of the blood collection bag 10 which have been collected in advance are transferred to the blood storage bag 30. At this time, the closing / opening means 95 is opened and 97, 91, 93 are closed. Next, only the blockage opening means 97 is opened to transfer the physiological saline from the drug solution (physiological saline) bag 60 to the blood storage bag 30. The concentrated red blood cells in the blood storage bag 30 are rocked by rocking means 78 with physiological saline added thereto,
Well mixed and diluted. Next, positive pressure is applied to the blood storage bag 30 by the pressure reducing / pressurizing means 75 to introduce the diluted concentrated red blood cell liquid into the membrane separator 40. On this occasion,
The closure opening means 95, 97 are closed, and the closure opening means 91, 93 are opened. The concentrated red blood cell liquid diluted in the blood storage bag 30 passes through the blood storage tube 17, reaches the membrane separator 40, and is separated into a liquid component and a blood cell component.
The drainage liquid is collected as a liquid component through the tube 19 in the liquid component bag 50, and the washed red blood cells are collected in the blood collection bag 1.
It is separated to the 0 side. The blood cell component once stored in the blood collection bag 10 is again collected in the blood storage bag 30, and the same dilution / separation operation is repeated. Mixing physiological saline with concentrated red blood cells is performed while rocking, so cleaning effect is high,
A series of operations can be performed in a closed system, and sterility is guaranteed.

Next, the action of deglycerinization of thawed red blood cells using the blood product preparing apparatus of FIG. 1 will be described.

The blood collection bag 10 containing thawed red blood cells is aseptically connected to the tube 12 and the tube 14 by the connecting means 20. A predetermined negative pressure is applied to the blood storage bag 30 to reduce / pressurize the blood.
The thawed red blood cells of the blood collection bag 10 that has been collected in advance are transferred to the blood storage bag 30 by applying 5 in FIG. At this time, the closing / opening means 95 is opened and 97, 91, 93 are closed. Next, only the blockage opening means 97 is opened to transfer the physiological saline from the drug solution (physiological saline) bag 60 to the blood storage bag 30. The thawed red blood cells in the blood storage bag 30 are mixed and diluted well by adding physiological saline and rocking by the rocking means 78. Next, reduce the positive pressure to the blood storage bag 30.
By applying with the pressurizing means 75, the diluted thawed red blood cell liquid is introduced into the membrane type separator 40. At this time, the closing opening means 95 and 97 are closed, and the closing opening means 9 is closed.
1, 93 open. The thawed red blood cell liquid diluted in the blood storage bag 30 passes through the blood storage tube 17, reaches the membrane separator 40, and is separated into a liquid component and a blood cell component. Glycerin for protecting red blood cells in the thawed red blood cells is collected as a drainage liquid through the tube 19 in the liquid component bag 50,
The washed red blood cells are separated to the blood collection bag 10 side.
The blood cell component once stored in the blood collection bag 10 is again collected in the blood storage bag 30, and the same dilution / separation operation is repeated. Mixing physiological saline with thawed erythrocytes is performed with rocking, so the washing effect is high.

Next, the operation of separating concentrated red blood cells and plasma from whole blood using the blood preparation device of FIG. 1 will be described.

The blood collection bag 10 for whole blood is aseptically connected to the tube 12 and the tube 14 by the connecting means 20.

By applying a predetermined negative pressure to the blood storage bag 30 by the pressure reducing / pressurizing means 75, the whole blood of the blood collection bag 10 which has been collected in advance is transferred to the blood storage bag 30. At this time, the closing / opening means 95 is opened and 97, 91, 93 are closed. The whole blood in the blood storage bag 30 is rocked by the rocking means 78 and mixed well. Next, positive pressure is applied to the blood storage bag 30 by the pressure reducing / pressurizing means 75 to introduce the blood in the blood storage bag 30 into the membrane separator 40. At this time, the closing opening means 95, 97 are closed, and the closing opening means 91, 93 are opened. The blood in the blood storage bag 30 passes through the blood storage tube 17, reaches the membrane separator 40, and is separated into a liquid component (plasma) and a blood cell component. Plasma is collected in the liquid component bag 50 through the tube 19, and the concentrated red blood cells are separated to the blood collection bag 10 side. If necessary, the blood cell components once stored in the blood collection bag 10 are collected again in the blood storage bag 30, and the same separating operation is repeated by the control means 80. After the separation is completed, only the blockage opening means 97 is opened, the red blood cell preservation solution is injected into the blood storage bag 30, and the liquid in the blood storage bag 30 is removed from the membrane separator 40.
Blood collection bag 1 while washing blood cells remaining in the tube
Can be recovered to zero. Finally, from the PRP (platelet-rich plasma) using the blood product preparation device of FIG.
The operation of separating (poor platelet plasma) and platelet concentrate will be described.

The tube 12 and the tube 14 of the blood collection bag 10 containing the PRP are aseptically connected by the connecting means 20.

By applying a predetermined negative pressure to the blood storage bag 30 by the decompression / pressurization means 75, the P of the blood collection bag 10 is
Transfer the RP to the blood storage bag 30. At this time, the closure opening means 9
5 is open and 97, 91 and 93 are closed. The PRP in the blood storage bag 30 is swung by the rocking means 78 and mixed well, and a positive pressure is applied to the blood storage bag 30 by the depressurizing / pressurizing means 75, whereby the blood in the blood storage bag 30 is Is introduced into the membrane separator 40. At this time, the block opening means 95, 97 are closed, and the block opening means 91, 93 are closed.
Open up. The PRP in the blood storage bag 30 passes through the blood storage tube 17 and reaches the membrane separator 40, where the liquid component (P
PP) and blood cell components (platelet concentrate) are separated. P
The PP is collected in the liquid component bag 50 through the tube 19, and the platelet concentrate is separated to the blood collection bag 10 side. The blood cell component once stored in the blood collection bag 10 is collected again in the blood storage bag 30, and the same separation operation is repeated until the platelet concentrate has a predetermined concentration. After reaching the predetermined concentration, only the closure opening means 97 is opened, and the drug solution bag 6
The platelet preservation solution may be injected into the platelet concentrate from 0.

[0040]

[Effect] The blood preparation device of the present invention is easy to operate,
Various blood products can be prepared.

[Brief description of drawings]

FIG. 1 is an overall view showing an embodiment of a blood product preparation device of the present invention.

FIG. 2 is a circuit diagram showing a disposable portion of FIG.

FIG. 3 is a conceptual diagram showing the operation of the connecting means of the blood product preparation device of the present invention.

FIG. 4 is a conceptual diagram showing the operation of the connecting means of the blood product preparation device of the present invention.

FIG. 5 is a conceptual diagram showing the operation of the connecting means of the blood product preparation device of the present invention.

FIG. 6 is a conceptual diagram showing the operation of the connecting means of the blood product preparation device of the present invention.

FIG. 7 is a circuit diagram showing a reference example of a blood product preparation device.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Blood product preparation device 10 Blood bag (blood cell collection means) 20 Connection means 30 Blood storage means 40 Membrane separation means 50 Liquid component storage means 60 Chemical liquid addition means 70 Transfer means 80 Control means

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Kaori Takahashi 1500 Inoguchi, Nakai-cho, Ashigarashami-gun, Kanagawa Terumo Co., Ltd.

Claims (1)

[Claims] 1. A connection means capable of aseptically connecting to a blood bag that has been collected in advance, a blood storage means for temporarily storing blood, and a membrane separation means for separating blood into blood cells and liquid components by a membrane. Liquid component storing means for storing a liquid component, blood cell collecting means for collecting separated blood cells, drug solution adding means for adding a drug solution to the blood collected in the blood bag, the blood, separated liquid component and blood cell component A transfer means for transferring at least one of the above, a drug solution adding means and a control means for controlling the transfer means, wherein the control means controls the blood in the blood bag connected by the connecting means. The liquid is transferred to the blood storing means, the chemical liquid is added to the blood storing means by the chemical liquid adding means, and is transferred from the blood storing means to the membrane separating means to separate into a liquid component and a blood cell component, and the liquid component is the liquid Success And stored in the storage unit, blood cell component is blood preparation system, which comprises carrying out one or more times a control for recovering the blood ball collection means.