JPH0512943B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a blood separation device that automatically separates blood components in a centrifuged blood bag into separation bags.

[Prior Art] Recently, the adverse effects of whole blood transfusion have been viewed as a problem. BACKGROUND ART Blood component transfusions have become popular with the aim of reducing the physical burden on patients and side effects caused by immunity as much as possible by transfusing only the components necessary for the patient among the various blood components.

On the other hand, in order to make a component preparation, it is necessary to fractionate the blood in a blood bag into each component using a centrifuge and separate each component into separate bags.

Therefore, in the past, a separation stand as shown in Figure 8 was used to manually separate the plasma in the centrifuged blood bag, and a tube sealer was used to seal the tube of the separation bag. I make it and seal it.

In other words, blood bag 1 after centrifugation
are set on the suspension pins 3, 3 of the separation stand 2 to prevent blood cells from flying up. At this time, after previously stopping the middle part of the tube 5 of the separation bag 4 with a needle 6, the needle release 7 attached to the tip of the tube 5 is inserted into the discharge port 1a of the blood bag 1, and both bags 1 and 4 are separated. communicate. Next, by removing the lever 8 of the separation stand 2 from the hook 9, the blood bag 1 and the fixing plate 10 of the separation stand 2 are removed.
and a pressing plate 1 that rotates via a lever 8 that is always biased in a predetermined direction by a spring (not shown).
1 and the cap 6 closing the middle part of the tube 5 is removed, and the plasma is separated into the separation bag 4. Plasma moves to separation bag 4,
When blood cells begin to enter tube 5, Kotsuheru 6
After closing the tube 5, the press plate 11 is returned to its original position, and the lever 8 is locked to the hook 9.

Next, pressure is applied to the separation bag 4 by hand, the cap 6 is opened, air is returned to the blood bag 1 side, and the tube 5 is closed by the cap 6.

[Problems to be Solved by the Invention] As described above, conventional separation operations have mainly been performed manually, which has the following drawbacks.

(1) It places a heavy burden on workers. That is, it is labor-intensive, the separation operation is performed one bag at a time, the separation operation must be stopped immediately upon visual detection of the blood component interface, and only one separation bag can be connected. , and only one component located at the top of the blood bag could be separated in one operation.
Furthermore, it has the disadvantage that applying pressure to the blood bag or separation bag must be done entirely manually. As a result, they may be overwhelmed with work.

(2) Separation stands, scales, scales, and other equipment are required separately, which requires a large installation space.

(3) Detection of blood component interfaces requires experience and intuition.

[Means for Solving the Problems] The present invention has been made for the purpose of solving the above-mentioned problems, and includes the following configuration in order to solve the problems.

That is, a pressurizing means that holds a centrifuged blood bag and pressurizes the held blood bag at a predetermined pressure, and at least two separation bags that communicate with the blood bag via a tube, and a measuring means for measuring the weight of the separation bag held by the measuring means; and a regulating means disposed in the middle of a tube between the separation bag held by the measuring means and the blood bag and regulating the movement of liquid within the tube. , a detection means for detecting an interface level of blood components in a blood bag held by the pressurizing means; and a control means for controlling the regulation means based on information on the weight measured by the measurement means of the separation bag and information detected by the detection means. Equipped with.

[Function] In the above configuration, the control means is configured to adjust the amount of blood components that are pressurized by the pressure means and flow out from the bag to the weight of the separation bag measured by the measurement means and the detection interface level of the detection means. By controlling the regulating means based on this, it is possible to automatically and accurately store a desired amount of a desired blood component in a separation bag. It is also possible to mix desired amounts of blood components.

Further, the control means utilizes the advantages of each means by regulating the regulating means by appropriately utilizing the measurement information and detection information of the above-mentioned measuring means and detection means, depending on the composition of the blood to be separated/mixed. This compact device can automatically and accurately separate and mix blood components in the desired amount without the need for experience or intuition. The usage order of measurement information and detection information at this time is not limited to the example described below, and it goes without saying that changes in the usage order can be applied at any time.

[Embodiments] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings.

1A to 1C are external views of one embodiment of the present invention, in which FIG. 1A is a plan view, FIG. 1B is a front view,
FIG. 1C is a side view.

In FIG. 1, 21 is a pressure plate that pressurizes the blood bag 51, 22 is a stopper that restricts the movement of the pressure plate, 23 is a measurement plate, and 24 is a weight indicator window, which is placed on the measurement plate 23. The measurement result of the weight of the object will be displayed. This measurement is carried out using a spring weighing mechanism using a parallel link mechanism, which has a built-in rotary encoder and outputs a signal proportional to the measured weight.

25 is an adjustment handle for adjusting the vertical position of the photo sensor 29; 26 is a worm gear fixed to the rotating shaft of the adjustment handle 25; 27 is a pinion gear that constantly meshes with the worm gear 26; the photo sensor 29 is fixed to the pinion gear 27. Reference numeral 28 denotes a pressure holding part that holds the blood bag 51 and pressurizes it with the pressure plate 21. Reference numeral 29 indicates a photo sensor that detects the concentrated red blood cells of the blood bag 51, which is suspended from a hook pin (not shown) of the pressure holding part 28. It is.

Reference numeral 31 denotes a hanger for suspending the separation bag, and the lower part thereof is a spring weighing mechanism using a parallel ring mechanism, in which a rotary encoder is built, and a signal proportional to the measured weight is output. Reference numeral 32 is a hanger for suspending a separation bag which can be attached as an option. 33 to 35 are clamp valves that clamp the tube sealer and control the flow of liquid in the tube, and when the valves are closed, the flow of liquid is stopped. Reference numeral 40 denotes an operation panel, which includes a power switch 15, a select switch 36 for mode selection, a start switch 37, and a stop switch 38. Further, 41 and 42 are handles, and 43 is a maintenance panel. Also, 5
Reference numerals 1 to 54 designate bags for containing blood components, which are also attached to the hanger 32 as required.

The configuration of the electrical control section of this embodiment will be explained with reference to the block diagram of FIG.

In the figure, 100 is the program cassette control section 11.
According to the program stored in the program cassette 200 attached to the connector section 115 of 4, the control section 101 that controls the entire control of this embodiment puts the pressure plate 21 in a non-pressurized state against the spring pressure built in. This is a pressurizing cylinder control section that controls the pressurizing cylinder 102 to be maintained. When the pressurizing cylinder 102 is stopped, the pressurizing plate 21 pressurizes the set bag using spring pressure from a spring (not shown). 103 calculates the weight of the bag from the output of a rotary encoder 105 which outputs a signal proportional to the weight of the bag suspended on the hanger 31 of a hanger weight measurement unit 104 disposed below the hanger 31, and outputs it to the control unit 100. hanger weight conversion section,
Reference numeral 106 denotes a weight conversion unit that calculates the bag weight based on the output of the rotary encoder 108 that outputs a signal proportional to the weight of the weight measurement unit 107 that measures the weight of the bag placed on the measurement plate 23, and outputs it to the control unit 100. be.

110-112 are clamp valves 1-3, 33
A valve control unit that controls opening/closing of ~35, 113
1 is a RAM, and 116 is an audio output control unit that controls and drives audio output such as a chime sound from the speaker 117. Further, 29 indicates a photo sensor shown in FIG. 1, and 36 to 38 indicate switches similarly shown in FIG.

The control of this embodiment having the above configuration will be explained below with reference to the flowcharts of FIGS. 3A and 3B.

First, in step S1, the "1" key of the select switch 36 is selected to set the first sequence. Subsequently, each bag is attached to each predetermined position. Here, the inside of the pressure plate is subjected to strong centrifugation (for example,
Set the blood bag 51 which has been subjected to 1700G to 5500G for 4 to 10 minutes, and place child bag 1 on the hanger 31.
52 is suspended, child bags 3, 53, and grandchild bags 54 are placed on the measurement plate 23, and in the following step S3, each bag and the blood bag are communicated with each other by a tube via clamp valves 1, 3, 33, and 35. . This state is shown in FIG. 1A, in which the hanger 32 and the tubes leading to the clamp valves 2, 34 are not provided.

Here, the blood bag 51 subjected to the strong centrifugation process is separated according to each blood component, and is in the state shown in FIG. 4. That is, a concentrated red blood cell layer 61 at the bottom,
A white blood cell layer 62 and a platelet layer 63 are formed thereon, and a plasma layer 64 is formed on top.

In the subsequent step S4, this blood bag 51 is set at the pressure plate 21 position, and as a result, the detection position of the photo sensor 29 is approximately at a predetermined position (for example, about 32 mm from the top surface of the blood bag 51 (position A in FIG. 4)).
level). If the photo sensor 29 is not at the predetermined position, move the photo sensor 29 up and down by rotating the adjustment handle 25 in step S5, adjust it to the predetermined position, and then proceed to step S5.
Proceed to S6. This is because the plasma layer 64 allows light to pass through, so the user can adjust the liquid volume by controlling the blood components to be sent to the child bags 1 and 52 until the photocoupler 29 detects the concentrated red blood cell layer 61. This is because there is.

Since the preparation for blood separation is now complete, the "start" switch 37 is pressed in step S6. Then, in the following step S7, the clamp valves 2, 34 and 3, 35 are closed to prevent liquid from flowing inside the set tube.
This prevents liquid from flowing into the child bag 2 (not set in this example) and the child bags 3 and 53. Then, in step S8, the pressure cylinder control unit 101 is instructed to release the pressure cylinder 102, and the pressure plate 21 presses down (pressurizes) the blood bag 51 by the pressure of the pressure plate spring. Therefore, as shown in step S9, the blood components in the blood bag 51 are transferred to the child bags 1, 33 through the opened clamp valves 1, 33.
52. For this reason, the following step S10
Then, it is checked whether the photo sensor 29 has detected the concentrated red blood cell layer 61, and if it has not detected it, it waits for detection. When the red blood cell level in the blood bag 51 is detected by the photocoupler 29, the process proceeds from step S10 to step S11, and the valve control section 1,110
to close the clamp valves 1 and 33. As a result, the flow of liquid into the child bags 1, 52 is stopped, and only the plasma layer 64 in the blood bag 51 is transferred to the child bags 1, 52.

Subsequently, in step S12, the weights of the empty child bags 3, 53 and grandchild bags 54 placed on the measurement plate 23 are measured (weight information is read from the weight converter 106), and the weights are stored in the RAM 113. do. Then, in step S13, the valve control section 3,
112 to open the clamp valves 3 and 35, and the blood components in the blood bag 51 are then transferred to the child bags 3 and 53, as shown in step S14. The control unit 100 converts the weight converter 1 in step S15.
Monitor the measured weight from 06 and check whether the "first set amount" (for example, 70 g) specified by the program cassette 200 has flowed in (has the weight increased)?
Find out. Here, when the transfer of the "first set amount" is completed, the process proceeds to step S16, where the valve controllers 3, 112 are controlled to close the clamp valves 3, 35, and the flow of liquid into the child bags 3, 53 is stopped. .
Then, in step S17, the pressurizing cylinder control section 101
is controlled to operate the pressure cylinder 102 and open the pressure plate 21. As a result, the child bags 3 and 53 contain platelets, some white blood cells and red blood cells, and the remaining plasma.

Next, in step S18, the valve controllers 1, 110 are controlled to open the clamp valves 1, 33, and as shown in step S19, blood components (plasma) fall naturally from the child bags 1, 52 to the parent bag blood. It flows into the bag 51. For this reason, the following step S20
Child bags 1 and 5 are hung on hanger 31.
2 is read from the hanger weight converter 103, and it is monitored whether or not the "set bag weight" (for example, 20 g) specified by the program cassette 200 has been input, and when the "set bag weight" is reached, the process proceeds to step S21. The valve control unit 110 is controlled to close the clamp valves 1 and 33, and the flow of liquid into the blood bag 51 is stopped.

As a result, a predetermined amount of plasma has flowed into the remaining concentrated red blood cells into the blood bag 51. As a result, the hematocrit value of concentrated red blood cell fluid can be corrected to, for example, 80% or less.

In the next steps S22 and S23, since the blood component separation has been completed, the sound output control section 116 is controlled to emit a chime several times from the speaker 117, and the start lamp 118 (the illumination section of the start switch 37, which is an illuminated switch) is activated. ) flashes. The operator thereby recognizes the end of the blood separation process, fixes and closes the tubes connecting the bags with clips, etc., and presses the end switch 38. Since the control unit 100 monitors the input of the end switch 38 in step S24, the process proceeds to step S25 based on the input of the end switch 38, and controls the valve control units 110 to 112 to open each clamp valve 33 to 35. and end the process.

In addition, although the above explanation describes an example in which the child bag 2 is not hung on the hanger 32, it is also possible to store an additive liquid for blood preservation in the child bag 2 to be supplied to the blood bag 51 as necessary, and to Following S17, a predetermined amount of this additive liquid may be supplied to the blood bag 51.

In this way, blood bag 51 and child bag 1,
52. Of the blood components separated into child bags 3 and 53, concentrated red blood cells 61, white blood cells 62, platelets 63 and some plasma 6 transferred to child bags 3 and 53.
4 can be further subdivided.

In this case, the child bags 3 and 53 are subjected to weak centrifugation. The mild centrifugation process is performed, for example, at 800G for about 5 minutes. As a result of this process, the child bags 3, 53 become in the state shown in FIG. 5, and the uppermost part becomes liquid platelets 65. By performing the mild centrifugation process in this manner, liquid platelets 65 are produced. Thereafter, the process according to FIG. 6 may be executed.

First, in step S50, the "2" switch of the select switch 36 is pressed to set the second sequence. Then, in the following step S51, the child bags 3 and 53 in the state shown in FIG. The tube is connected to the clamp valve 3,
Pass it to 35. Then, as in step S4, it is checked whether the photo sensor 29 is at a predetermined position or not, and if it is not at a predetermined position, the adjustment handle 25 is rotated in step S53 to set the photo sensor 29 at a desired position. Then, the process advances to step S54, and the start switch 37 is pressed. Start switch 37
The control unit 100 that detects the on state controls the pressure cylinder control unit 101 to open the pressure cylinder, and presses the pressure plate 21 against the child bag 3, 53 by a pressure plate spring force (not shown). Subsequently, in step S56, the clamp valves 3 and 35 are opened, and the liquid contents of the child bags 3 and 53 pressed together by the pressure plate 21 are transferred to the grandchild bag 54. Then, in the following step S58, it is monitored whether or not the photo sensor 29 has detected red blood cells. When the photo sensor 29 detects red blood cells, the process advances to step S59, and the valve control section 11
0 to close the clamp valves 3 and 35. Then, in steps S60~S62, steps S22~
Same as 24, output chime sound and start lamp 1
18 blinks and waits for the push input of the end switch 38. When the operator recognizes the end of the second sequence process, performs the necessary processes, and presses the end switch, the process proceeds from step S62 to step S63, where the clamp valves 1 to 3 are opened and the process ends.

By controlling in this way, child bags 3 and 5
Only liquid platelets 65 can be separated from concentrated red blood cells 61, white blood cells 62, and liquid platelets 65 in 3.

The above explanation has been made regarding an example in which the photo sensor 29 is used to control the separation of the content liquid from the child bags 3 and 53, but in addition to this, the device of this embodiment also performs this separation by weight measurement. I can do it. An example in which this separation is carried out by weight measurement will be explained with reference to the flowchart of FIG.

First, in step S100, the "3" switch of the select switch 36 is pressed to set the third sequence. Then, in the following step S101, the previous fifth
The child bags 3 and 53 in the state shown in the figure are set on the pressure plate 21, and the grandchild bag 54 is placed on the measurement plate 23. In the next step S102, the tube passes through the clamp valves 3, 35, and the child bags 3, 53 and grandchild bag 54 are clamped midway and communicated with each other. Then, in step S103, the start switch 37 is pressed. When the control unit 100 detects the depression input of the start switch 37, the process immediately proceeds to step S104, and controls the valve control unit 110 to close the clamp valves 3 and 35. Then, in step S105, the weight of the grandchild bag 54 placed on the measurement plate 23 is measured, and the weight of the grandchild bag 54 placed on the measurement plate 23 is measured.
Store within 3. Then, in step S106, the pressure cylinder control section 101 is controlled to open the pressure cylinder, and the pressure plate 21 is pressed against the child bag 3, 53 by the pressure plate spring pressure (not shown). Next, the clamp valves 3 and 35 are opened at step S107, and the pressure plate 21 is opened as shown at step S108.
The blood components of the child bags 3 and 53 are transferred to the grandchild bag 54 by pressure contact.

Then, in step S109, the weight of the grandchild bag 54 is read and monitored by the weight converter 106, and whether the amount specified by the program cassette 200 (for example, about 40 g) has been transferred and the weight of the grandchild bag 54 has reached a predetermined amount. Find out whether or not. When the predetermined amount of transfer is completed, the process advances to step S110, and thereafter the steps shown in FIG. 6 are performed in steps S110 to S114.
Processing similar to steps S59 to S63 is executed.

As explained above, the blood separation device of this embodiment is capable of handling each blood sample in a multi-bag system (e.g., double bag, triple bag, quadruple bag, SAG bag system, etc.) used for blood component preparations using the centrifugal method. This device automatically separates components (red blood cells, white blood cells, platelets, plasma) into predetermined blood components, and can reduce the burden on the operator compared to conventional manual separation operations. Separation stand function, blood component interface detection function, clamp function, all in one device.
It is made more compact by incorporating a weight measurement function (tube seal function), etc.

In addition, experience and intuition were required to detect the interface between blood components and to control the amount (weight) of each blood component, but with this device, anyone can separate blood components into uniform blood components. The effects can be expected.

[Effects of the Invention] As explained above, according to the present invention, the control means is configured to measure the amount of blood components pressurized by the pressure means and flowing out from the bag, and the weight of the separation bag measured by the measuring means. By controlling the regulating means based on the detected interface level by the detecting means, it is possible to automatically and accurately store a desired amount of a desired blood component in a separation bag. It is also possible to mix predetermined amounts of blood components.

Moreover, with a compact device, a desired amount of blood components can be separated and mixed automatically and accurately without the need for experience or intuition.

[Brief explanation of the drawing]

Figures 1A to C are external views of an embodiment of the present invention, Figure 2 is a block diagram of the embodiment, and Figures 3A and B are the flowchart of the first sequence of blood component separation in this embodiment. Figure 4 is a diagram showing the state of a blood bag that has been subjected to strong centrifugation, and Figure 5 is a diagram that shows the state of a child bag that has been subjected to weak centrifugation after separation processing according to the first sequence of this embodiment. , FIG. 6 is a flowchart of the second sequence of this embodiment, FIG. 7 is a flowchart of the third sequence of this embodiment, and FIG. 8 is an external view of a conventional blood component separation device. In the figure, 11, 21... pressure plate, 23...
Measuring plate, 25...Adjustment handle, 26...
Worm gear, 27...Pinion gear, 29...
Photo sensor, 31, 32...Hanger, 33-3
5...Clamp valve, 36...Select switch, 37...Start switch, 38...End switch, 41, 42...Handle, 51...Blood bag, 52, 53...Child bag, 54...Grandchild bag , 61...Dense red blood cell layer, 62...White blood cell layer,
63... Platelet layer, 64... Plasma layer, 65... Liquid platelet layer, 100... Control section, 101... Pressure cylinder control section, 102... Pressure cylinder, 10
3... Hanger weight conversion section, 104... Hanger weight measurement section, 105, 108... Rotary encoder, 106... Weight conversion section, 107... Weight measurement section, 110-112... Valve control section, 113...
...RAM, 114...program cassette control section, 115...connector section, 116...sound output control section, 117...speaker, 118...start lamp, 200...program cassette.

Claims (1)

[Scope of Claims] 1. Pressurizing means for holding a centrifuged blood bag and pressurizing the holding blood bag at a predetermined pressure; and holding at least two separation bags communicating with the blood bag via a tube. At the same time,
a measuring means for measuring the weight of the separation bag held by the measuring means; disposed midway in the tube between the separation bag held by the measuring means and the blood bag;
a regulating means for regulating the movement of liquid within the tube; a detecting means for detecting an interface level of blood components in the blood bag held by the pressurizing means; information on the weight measured by the measuring means of the separation bag; A blood separation apparatus comprising: a control means for controlling the regulating means based on detection information of the detection means. 2. The detection means includes a light emitting means and a light receiving means that receives the light emitted by the light emitting means and transmitted through the blood bag, and detects the interface level by changing the amount of transmitted light due to differences in blood components in the blood bag. A blood separation device according to claim 1, characterized in that the blood separation device performs the following steps. 3 The tube extending from the blood bag is the first tube on the way.
A patent characterized in that the tube is branched into a tube communicating with a second separation bag and a tube communicating with a second separation bag, and a regulating means is disposed between the branch point of the tube and each separation bag. A blood separation device according to claim 1 or 2. 4. The blood separation device according to any one of claims 1 to 3, wherein at least one of the bag holding means for holding the separation bag is located above the pressurizing means.