JP4641778B2 - Blood component collection device - Google Patents

Description

  The present invention relates to a blood component collection device.

  When collecting blood, the collected blood is separated into each blood component by centrifugation, etc. for reasons such as effective use of the blood and reduction of the burden on the donor, and only the components necessary for the transfuser are collected. Blood is collected to return to the person.

  In such component blood collection, for example, when obtaining a plasma preparation, blood collected from a blood donor is introduced into a blood component collection circuit using a blood component collection device, and the centrifuge bowl installed in the blood component collection circuit The blood cell is separated into plasma and blood cells by using a centrifuge, and the plasma is collected in a blood component collection bag to obtain a plasma preparation, and the blood cells are returned (returned) to the blood donor together with the remaining plasma. That is, when collecting plasma, a blood component collection operation including a blood component collection step of collecting plasma and a blood component return step of returning the remaining blood components (mainly blood cells) to the donor is performed in a plurality of cycles (for example, , See Patent Document 1).

  In such a blood component collection device, the operator determines the number of cycles of blood component collection operation based on the predicted value of the amount of plasma desired to be collected in one cycle and the target amount of plasma to be collected. For example, when the amount of plasma to be collected in one cycle is 180 mL and the target amount of plasma to be collected is 600 mL, the operator recognizes that four cycles are necessary in the blood component collection operation, and inputs the number of cycles to the blood component collection device. Thus, the cycle number of the blood component collection operation is set.

  However, in the conventional blood component collection device, since the operator determines the number of cycles for blood component collection operation and inputs it to the blood component collection device, it takes time and effort to set the number of cycles for blood component collection operation. .

  Further, since the operator determines the number of cycles for blood component collection operation, an error may occur in setting the number of cycles.

  In addition, when the amount of plasma actually collected in one cycle is smaller than the amount of plasma desired to be collected in one cycle, it may not be possible to collect a target amount of plasma.

JP 2001-17540 A

  An object of the present invention is to provide a blood component collection device that can easily and accurately set the number of cycles of blood component collection operations.

Such an object is achieved by the present inventions (1) to ( 5 ) below.
(1) Blood collection means for collecting blood from a donor,
A centrifuge for centrifuging blood collected by the blood collection means;
A blood component collection circuit comprising a blood component collection bag for collecting a predetermined blood component separated by the centrifuge;
Blood that performs at least one cycle of blood component collection operation, which includes centrifugation of the collected blood to collect the predetermined blood component and a blood component return step of returning the remaining blood component to the donor A component collecting device,
When a plurality of end conditions for ending the blood component collection step are set and any one of the plurality of end conditions is satisfied, the blood component collection step is ended and the blood component return step is performed. Is composed of
Target sampling amount input means for inputting a target sampling amount of the predetermined blood component;
Target sampling amount setting means for setting the input target sampling amount;
Predicting means for predicting the amount of the predetermined blood component collected per cycle for each of the cases where the end conditions are satisfied and the blood component collecting step is terminated;
The prediction means on the basis of the minimum value of each prediction value predicted by, possess a number of cycles determining means for determining the number of cycles the blood component collection operation,
The predicting means sequentially predicts the amount of the predetermined blood component collected per cycle from the first cycle for each of the cases where the blood component collection step is completed by satisfying the termination conditions,
The cycle number determining means sequentially adds the minimum value from the first cycle, and the number of cycles when the added value is equal to or greater than the set target collection amount of the predetermined blood component. Is determined as the number of cycles of the blood component collection operation .

( 2 ) having blood donor information input means for inputting information about the blood donor,
For at least one of the end conditions, the prediction means inputs the sampling amount of the predetermined blood component per cycle when the end condition is satisfied and the blood component collecting step is ended. The blood component collection device according to (1 ), wherein the blood component collection device is configured to perform prediction based on information related to a blood donor.

( 3 ) The blood component collection device according to ( 2 ), wherein the information about the blood donor includes at least one of sex, height, weight, and hematocrit value.

( 4 ) The plurality of termination conditions include a case where blood cells flow out of the centrifuge, a case where the blood collection amount per cycle reaches an allowable extracorporeal blood circulation amount, and the collection of the predetermined blood component per cycle. The blood component collection device according to any one of (1) to ( 3 ), wherein at least one of a case where the amount reaches a preset value is included.

( 5 ) The blood component collection device according to any one of (1) to ( 4 ), wherein the predetermined blood component is plasma.

  According to the present invention, since the number of cycles for blood component collection operation is automatically set, the operation (operation) for setting the number of cycles is easy.

  In addition, since the number of cycles of blood component collection operation is determined based on the minimum value among a plurality of predicted values of the amount of blood component collected per cycle, the target amount is insufficient because the number of cycles of blood component collection operation is insufficient. It is possible to prevent the blood component from being collected. That is, the number of blood component collection operations can be accurately set, and a target amount of blood components can be reliably collected.

  Hereinafter, the blood component collection device of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

  FIG. 1 is a plan view (partly including a block diagram) showing an embodiment when the blood component collection device of the present invention is applied to a plasma collection device that mainly collects plasma, and FIG. FIG. 2 is a partially broken cross-sectional view of a state in which a centrifuge drive device is mounted on a centrifuge provided in the blood component collection device shown in FIG.

  A blood component collection device (plasma collection device) 1 shown in FIG. 1 includes a hollow needle assembly (blood collection means for collecting blood from a donor) including a hollow needle (blood collection needle) 291 that is punctured into a donor (blood donor) blood vessel. 29, a centrifuge (centrifugal bowl) 20 that centrifuges the collected blood in the blood storage space 146, and a plasma collection bag (blood component collection) that collects plasma (blood components) separated by the centrifuge 20 A blood component collection circuit 2 having a bag 25, and after centrifuging blood collected from a donor and collecting a predetermined amount of plasma, leukocytes, platelets and red blood cells (remaining blood components) are collected together with the remaining plasma. It is a device that returns it to the donor.

  The blood component collection device 1 is connected to a hollow needle assembly 29, a blood collection / return line 21 used as both a blood collection line and a blood return line, a centrifuge 20, and an outlet 144 of the centrifuge 20 The collection bag side line 22, the anticoagulant injection line 23 connected to the blood collection / return line 21, and the collection bag side line 22 are connected to the centrifuge through the collection bag side line 22. An air bag side line 24 communicating with the 20 outlets 144; a plasma collection bag 25 connected to the collection bag side line 22; a subbag 32 connected to the plasma collection bag 25 by a tube (flow path) 32a; The blood component collection circuit 2 includes an airbag 26 connected to the airbag-side line 24.

  The blood component collection device 1 includes a centrifuge drive device 10 for rotating the rotor 142 of the centrifuge 20, a blood pump 11 for feeding blood or blood components in the blood collection / return line 21, The anticoagulant pump 12 for feeding the anticoagulant in the anticoagulant injection line 23, the first channel opening / closing means 51 for opening and closing the channel of the blood component collection circuit 2, and the second channel Control means 55 for controlling the opening / closing means 52, the centrifuge drive device 10, the blood pump 11, the anticoagulant pump 12, the first channel opening / closing means 51, the second channel opening / closing means 52, and the like; Turbidity sensor 14, optical sensor 15, weight sensor 16, first bubble sensor 17, second bubble sensor 34, third bubble sensor 35, fourth bubble sensor 36, 5 bubble sensor 37 and touch panel And a 9.

Hereinafter, the configuration of each unit will be described.
The hollow needle assembly 29 includes a hollow needle 291 that is punctured into a donor's blood vessel, a wing 292, and a tube 293 that communicates with the hollow needle 291. In FIG. 1, the hollow needle 291 is covered with a cap. The hollow needle assembly 29 is detachably connected to one end of the blood collection / return line 21 via a connector 38. The connector 38 is constituted by a luer connector with a lock, for example.

  The blood collection / return line 21 includes a centrifuge side line 21b in which a hollow needle side line 21a in which a hollow needle assembly 29 is connected to one end via a connector 38 and an inflow port 143 of the centrifuge 20 are connected. And a pump tube 21g disposed between them.

  The hollow needle side line 21a includes a chamber 21d for removing bubbles and microaggregates.

  An air-permeable and bacteria-impermeable filter 21i is connected to the chamber 21d through a tube (flow path) 21h. This line can be used for detecting the internal pressure (donor pressure) of the hollow needle side line 21a.

  The collection bag side line 22 has one end connected to the outlet 144 of the centrifuge 20 and the other end connected to the plasma collection bag 25. In the middle of the collection bag side line 22, a branch connector 61 is provided that branches into three (three forks) (a total of four connection ports). The collection bag side line 22 is connected via the branch connector 61. Connected.

  The branch connector 61 is connected to a filter 63 that is air-permeable and bacteria-impermeable through a tube (flow path) 62. This line can be used, for example, for detecting the internal pressure of the centrifuge 20.

  One end of the anticoagulant injection line 23 is connected to a connection branch connector 21 c provided in the blood collection / return line 21. The anticoagulant injection line 23 includes a pump tube 23a, a sterilization filter (infusion filter) 64, a bubble removal chamber 23c, and an anticoagulant container connection needle 23d from the connection branch connector 21c side. In FIG. 1, the anticoagulant container connecting needle 23d is covered with a cap.

  The airbag side line 24 is connected to the branch connector 61. That is, the air bag 26 is provided to be branched from the collection bag side line 22 through the air bag side line 24.

  Each of the blood pump 11 and the anticoagulant pump 12 is constituted by a roller pump (tube pump) having a rotor that rotates while pressing and closing the pump tubes 21g and 23a with a plurality of rollers.

  Tubes used to form blood collection / return line 21, collection bag side line 22, anticoagulant injection line 23 and airbag side line 24, pump tubes 21g and 23a, tubes 32a connected to the bag, chamber As a constituent material of the tube 21h connected to 21d and the tube 62 connected to the branch connector 61, polyvinyl chloride is preferable.

  If each tube is made of polyvinyl chloride, sufficient flexibility and softness can be obtained, so that it is easy to handle and is suitable for clogging with a clamp or the like.

  In addition, as each pump tube 21g and 23a, what has the intensity | strength of the grade which is not damaged even if it presses with a roller pump is used.

  Further, as the constituent materials of the connecting branch connector 21c and the branch connector 61 described above, the same constituent materials as those of the tube can be used.

  The plasma collection bag 25 is a container for collecting plasma, and is connected to the centrifuge 20 via the collection bag side line 22, whereby the inside of the plasma collection bag 25 is stored in the blood storage space 146 of the rotor 142. Communicating with

  The sub bag 32 is connected to the plasma collection bag 25 via the tube 32a, and the insides thereof communicate with each other. This subbag 32 can be used, for example, as a plasma storage bag.

  The airbag 26 is a container for temporarily storing (storing) air (air), and is connected to the branch connector 61 via the airbag-side line 24. That is, the air bag 26 is connected to the centrifuge 20 via the air bag side line 24, the branch connector 61, and the collection bag side line 22, whereby the inside of the air bag 26 is connected to the blood storage space 146 of the rotor 142. Communicating with

  Each of the plasma collection bag 25, the sub bag 32, and the air bag 26 is laminated with a resin-made flexible sheet material, and its peripheral portion is fused (heat fusion, high frequency fusion, etc.) or bonded. A bag is used.

  As a material used for the plasma collection bag 25, the sub bag 32, and the air bag 26, for example, soft polyvinyl chloride is preferably used.

  The centrifuge 20 provided in the blood component collection circuit 2 is generally called a centrifuge bowl, and separates blood into plasma and blood cells (platelets, white blood cells, and red blood cells) by centrifugal force. As the centrifuge 20, the one shown in FIG. 2 is used.

  The first flow path opening / closing means 51 is provided to open and close the middle of the flow path of the airbag side line 24.

  The second flow path opening / closing means 52 is provided to open and close the flow path of the collection bag side line 22 on the plasma collection bag 25 side from the branch connector 61.

  The first flow path opening / closing means 51 and the second flow path opening / closing means 52 include a line or tube insertion portion, and the insertion portion includes a drive source such as a solenoid, an electric motor, a cylinder (hydraulic pressure or air pressure), for example. It has a clamp that operates at Specifically, an electromagnetic clamp that operates with a solenoid is suitable.

  As shown in FIG. 2, the centrifuge drive device 10 includes a housing 201 that houses the centrifuge 20, a leg portion 202, a motor 203 that is a drive source, and a disk-shaped fixing that holds the centrifuge 20. It is comprised with the stand 205. FIG. The housing 201 is placed and fixed on the upper portion of the leg portion 202.

  In addition, a motor 203 is fixed to the lower surface of the housing 201 via a spacer 207 with bolts 206. A fixed base 205 is fitted on the tip of the rotating shaft 204 of the motor 203 so as to rotate coaxially and integrally with the rotating shaft 204, and the bottom of the rotor 142 is fitted on the upper portion of the fixed base 205. A concave portion is formed.

  The upper portion 145 of the centrifuge 20 is fixed to the housing 201 by a fixing member (not shown). In the centrifuge drive device 10, when the motor 203 is driven, the fixed base 205 and the rotor 142 fixed thereto rotate under a predetermined centrifugal condition (for example, a rotational speed of 3000 to 6000 rpm). Under this centrifugal condition, a blood separation pattern (for example, the number of blood components to be separated) in the rotor 142 can be set.

  In the rotor 142, the volume of the blood storage space 146 is, for example, about 100 to 350 mL.

  The optical sensor 15 is installed on the side of the housing 201 (left side in FIG. 2).

  The optical sensor 15 is configured to project light toward the blood storage space 146 and to receive the reflected light.

  The optical sensor 15 irradiates (projects) light (for example, laser light) from the light projecting unit 151, and the reflected light reflected by the reflecting surface 147 of the rotor 142 is received by the light receiving unit 152. The light receiving unit 152 converts the received light quantity into an electrical signal.

  Here, the optical sensor 15 has a reflecting surface on one side and a reflecting plate 153 that changes the optical path, and the light irradiated from the light projecting unit 151 passes through the reflecting plate 153 and is reflected on the reflecting surface 147. The light that is irradiated to the light and reflected by the reflecting surface 147 is received by the light receiving unit 152 via the reflecting plate 153.

  At this time, the projection light and the reflected light are transmitted through the blood component in the blood storage space 146, but at the position of the blood component interface (in the present embodiment, the interface B between the plasma layer 131 and the blood cell layer 132). Accordingly, since the abundance ratios of the blood components at the positions where the light projection light and the reflected light are transmitted are different, their transmittances are changed. As a result, the amount of light received by the light receiving unit 152 varies (changes), and this variation can be detected as a change in the output voltage from the light receiving unit 152.

  That is, the optical sensor 15 can detect the position of the blood component interface based on the change in the amount of light received by the light receiving unit 152.

  Here, the plasma layer 131 and the blood cell layer 132 in the blood storage space 146 have different colors depending on the blood components, respectively, and the blood cell layer 132 is red with the color of the red blood cells. For this reason, from the viewpoint of improving the accuracy of the optical sensor 15, there is a range suitable for the wavelength of the projection light, and the wavelength range is not particularly limited, but is preferably about 600 to 900 nm, for example. 750 to 800 nm is more preferable.

  The weight sensor 16 constitutes detection means for detecting the amount of plasma collected in the plasma collection bag 25.

  The turbidity sensor 14 is for detecting the turbidity of the fluid flowing in the collection bag side line 22 and outputs a voltage value corresponding to the turbidity. Specifically, a low voltage value is output when the turbidity is high, and a high voltage value is output when the turbidity is low.

  The turbidity sensor 14 can detect, for example, the mixing of blood cells into plasma flowing through the collection bag side line 22.

  The first bubble sensor 17 is for detecting that air has flowed into the blood collection / return line 21. That is, the presence or absence of blood in the blood collection / return line 21 is detected by the first bubble sensor 17.

  The fourth bubble sensor 36 and the fifth bubble sensor 37 are for detecting that bubbles have passed. These prevent air from being injected into the donor.

  The second bubble sensor 34 prevents air in the anticoagulant injection line 23 from being emptied (so that it is filled with the anticoagulant). Used to detect the presence or absence of a coagulant.

  The third bubble sensor 35 is for detecting that air or blood (plasma) has flowed into the collection bag side line 22 between the outlet 144 of the blood storage space 146 of the centrifuge 20 and the branch connector 61. Is. That is, the presence or absence of blood in the collection bag side line 22 is detected by the third bubble sensor 35.

  As the turbidity sensor 14 and the bubble sensors 17, 34, 35, 36, and 37, for example, an ultrasonic sensor, an optical sensor, an infrared sensor, or the like can be used.

  The control means 55 is composed of, for example, a microcomputer or the like, and includes a centrifuge drive device 10, a blood pump 11, an anticoagulant pump 12, a first flow path opening / closing means 51, and a second flow path opening / closing means 52. , Turbidity sensor 14, optical sensor 15, weight sensor 16, first bubble sensor 17, second bubble sensor 34, third bubble sensor 35, fourth bubble sensor 36, fifth bubble sensor 37 and Each is electrically connected to the touch panel 19 or the like. The control means 55 includes a calculation unit and a memory (both not shown).

  By this control means 55, a predicting means for predicting the amount of plasma (blood component) collected per cycle, a cycle number determining means for determining the number of cycles of the plasma collecting operation (blood component collecting operation), and plasma (blood component) The main function of the target sampling amount setting means for setting the target sampling amount is achieved.

  The touch panel 19 includes a liquid crystal display panel, an EL display panel, and the like. The touch panel 19 functions as an input unit (operation unit) that receives an input of an operator's instruction, and a display unit (notification unit) that displays (notifies) various types of information. It has the function as. This touch panel 19 constitutes a target collection amount input means for inputting a target collection amount of plasma (blood component) and a donor information input means for inputting information (donor information) related to the donor (donor information).

  Note that input means (for example, operation buttons, operation switches, operation dials and the like) and display means (notification means) such as a liquid crystal display panel and an EL display panel may be provided separately.

  From the turbidity sensor 14, the optical sensor 15, the weight sensor 16, the first bubble sensor 17, the second bubble sensor 34, the third bubble sensor 35, the fourth bubble sensor 36 and the fifth bubble sensor 37. Each detection signal is input to the control means 55 as needed. Further, from the touch panel 19, a signal corresponding to the instruction content of the operator input to the touch panel 19 is input to the control means 55 as needed. Based on the signals from these, the control means 55 operates the blood component collection device 1 according to a preset program, that is, the rotation, stop, or rotation direction of the blood pump 11 and the anticoagulant pump 12 (normal (Rotation / reverse rotation) and the opening / closing of each flow path opening / closing means 51 and 52 and the operation of the centrifuge drive device 10 are controlled as necessary.

  Such control means 55 causes blood collected from the donor to flow into the centrifuge 20 (blood storage space 146), and collects (transfers) the plasma separated by the centrifuge 20 into the plasma collection bag 25. Plasma collection step (blood component collection step) and blood return step (blood cell return step) (blood component return step) (return blood) mainly returning blood cells (remaining blood components) remaining in the centrifuge 20 to the donor The operation of the blood component collection apparatus 1 is controlled so as to perform a plasma collection operation (blood component collection operation). This plasma collection operation is performed at least once (one cycle), and usually a plurality of times (multiple cycles).

  In addition, when a plurality of end conditions for ending the plasma collection process are set and any one of the plurality of end conditions is satisfied, the plasma collection process is ended and the blood return process is performed (the blood return process). Transition).

Hereinafter, the usage method and operation of the blood component collection device 1 will be described.
First, the operator primes the anticoagulant injection line 23 and the hollow needle assembly 29 with the anticoagulant, and then punctures the hollow needle 291 into the donor's blood vessel. This completes preparation for plasma collection.

  Next, the operator presses the collection start switch displayed on the touch panel 19. Thereby, the program is executed by the control means 55 and the plasma collection operation is started. In the plasma collection operation, the blood component collection device 1 first performs a plasma collection step.

  In the plasma collection process, the blood pump 11 is rotated clockwise (in the normal direction) in FIG. 1 to start blood collection. At the same time, the first flow path opening / closing means 51 is opened, the second flow path opening / closing means 52 is closed, and the blood storage space 146 of the centrifuge 20 is collected via the collection bag side line 22 and the airbag side line 24. The air (sterilized air) in the blood component collection circuit 2 such as the inside is transferred into the airbag 26 and stored.

  Simultaneously with the blood collection, the anticoagulant pump 12 is rotated counterclockwise in FIG. 1 to supply an anticoagulant such as ACD-A solution through the anticoagulant injection line 23. An anticoagulant is added to the blood sample.

  As a result, blood (blood added with an anticoagulant) is transferred through the blood collection / return line 21 and introduced into the blood storage space 146 of the rotor 142 from the inlet 143 of the centrifuge 20 via the tube 141. .

  At this time, the air in the blood storage space 146 of the centrifuge 20 is transferred and stored in the airbag 26 via the collection bag side line 22 and the airbag side line 24.

  Simultaneously with or before or after the blood collection, the centrifuge drive device 10 is operated to rotate the rotor 142 at a predetermined rotational speed. By the rotation of the rotor 142, the blood introduced into the blood storage space 146 is separated into two layers, a plasma layer (PPP layer) 131 and a blood cell layer 132 from the inside.

  Further, when the blood collection and the supply of the anticoagulant are continued and the anticoagulant-added blood exceeding the capacity of the blood storage space 146 is introduced into the blood storage space 146, the blood storage space 146 is completely filled with blood, Plasma overflows from the outlet 144 of the centrifuge 20.

  Next, when plasma flowing out from the blood storage space 146 of the centrifuge 20 is detected by the third bubble sensor 35, the storage of the air in the blood storage space 146 into the airbag 26 is completed.

  The plasma overflowed from the centrifuge 20 flows through the collection bag side line 22.

  Next, the first channel opening / closing means 51 is closed, the second channel opening / closing means 52 is opened, and the plasma in the blood storage space 146 of the centrifuge 20 is collected via the collection bag side line 22. Transfer into bag 25 and collect.

  Note that the weight of the plasma collection bag 25 is measured by the weight sensor 16, and the measured weight signal is input to the control means 55.

  Next, the end of plasma collection is determined. In this case, in the present embodiment, in each cycle other than the final cycle, the following three end conditions, that is, end conditions 1 to 3 are set, and if any one of these is satisfied (detection) Then, plasma collection is terminated. Further, in the final cycle, the following four end conditions, that is, end conditions 1 to 4 are set, and when any one of these is satisfied (detected), the plasma collection is ended.

(Termination condition 1)
When blood cells flow out from the centrifuge 20, that is, when blood cells are detected by the turbidity sensor 14.

(Termination condition 2)
When the amount of blood collected per cycle reaches the allowable extracorporeal blood volume.

(Termination condition 3)
When the amount of plasma collected per cycle (plasma collected amount) reaches a preset value, that is, the amount of plasma collected per cycle detected by the weight sensor 16 is equal to the set plasma collected amount per cycle (upper limit). Value).

(Termination condition 4)
The current plasma collection amount (total plasma collection amount) detected by the weight sensor 16 reaches the target plasma collection amount (target plasma collection amount).

  Here, the set plasma collection amount per cycle in the end condition 3 and the target plasma collection amount in the end condition 4 can be input (changed) by the operator by operating the touch panel 19, respectively. Yes. When the value of the set plasma collection amount per cycle is input, the set plasma collection amount per cycle is set to the input value. Similarly, when the value of the target plasma collection amount is input, the target plasma collection amount is set to the input value.

  A predetermined value (for example, 250 mL) is set (preset) in advance as an initial value of the set plasma collection amount per cycle.

  When plasma collection ends, the operation of the blood pump 11 and the anticoagulant pump 12 is stopped, the operation of the centrifuge drive device 10 is stopped, and the rotation of the rotor 142 of the centrifuge 20 is stopped.

  With the above, the plasma collection process is completed, and the process returns to the blood return process. In this blood return step, the blood components remaining in the blood component collection circuit 2 (mainly the blood storage space 146 of the rotor 142) are returned to the donor. Specifically, first, the first flow path opening / closing means 51 is opened, the second flow path opening / closing means 52 is closed, and the blood pump 11 is rotated (reversed) counterclockwise in FIG.

  Thereby, the remaining blood components in the blood storage space 146 of the rotor 142 are returned to the donor via the centrifuge side line 21b, the hollow needle side line 21a, and the hollow needle assembly 29.

  Next, when air is detected by the first bubble sensor 17, the blood return is terminated, and the process proceeds to the plasma collection step of the plasma collection operation of the next cycle.

  When this cycle is the final cycle, blood is returned when air is detected by the fifth bubble sensor 37. Thereby, almost all the remaining blood components in the blood component collection circuit 2 are returned to the donor, and the plasma collection operation is completed.

  The blood component collection device 1 is configured to automatically determine the value of the number of cycles of the plasma collection operation described above and set the value as the number of cycles of the plasma collection operation. That is, the blood component collection device 1 satisfies each termination condition (termination conditions 1 to 3) in each cycle other than the final cycle and terminates the plasma collection process. The number of cycles of the plasma collection operation described above is determined and set based on the predicted minimum value among the predicted values.

  In this case, in this embodiment, for each of the cases where the plasma collection process is completed by satisfying each of the end conditions 1 to 3, the amount of plasma collected per cycle is sequentially predicted from the first cycle, and the minimum value is Sequential addition (accumulation) is performed from one cycle, and the number of cycles when the added value is equal to or greater than the target plasma collection amount (target plasma collection amount) is determined as the cycle number of the plasma collection operation. .

  Moreover, in the blood component collection device 1, an operator can input information (donor information) related to a donor (blood donor) by operating the touch panel 19.

  Examples of the information on the donor include (included) sex, height, weight, hematocrit value (Hct), and the like.

  And in this blood component collection device 1, about the end conditions 1 and 2, respectively, the amount of plasma collected per cycle when the end condition is satisfied and the plasma collection step is finished is based on the information on the donor. Predict. Below, the specific example of the method of estimating the collection amount of the plasma per cycle is demonstrated about each when each completion | finish conditions 1-3 are satisfy | filled and a plasma collection process is complete | finished.

(Prediction method for end condition 1)
The amount of plasma collected per cycle (predicted value) A [mL] is obtained (calculated) from the following formula (1) based on the hematocrit value (Hct) of the donor. It should be noted that the formula (1) to be applied differs between the first cycle and the second and subsequent cycles.

A [first cycle] = 670−10 × Hct
[After the second cycle] = 530−8 × Hct (1)
The expression (1) is stored in the memory of the control means 55. For example, the data may be tabulated and the table may be stored.

(Prediction method for end condition 2)
The amount of plasma collected per cycle (predicted value) A [mL] is obtained (calculated) from the following equation (2) based on the sex, height and weight of the donor.

A = TBV × (allowable circulation rate) − (volume of blood storage space [mL]) (2)
However, TBV [mL] is a donor's circulating blood volume, and is calculated (calculated) from the following equation (3). In addition, this formula (3) is applied differently depending on gender (male and female). The allowable circulation rate is usually 15%.

TBV [male] = 0.168Hi ³ +0.050 Wt + 0.444
[Women] = 0.250Hi ³ + 0.063Wt + 0.662 Formula (3)
However, Hi: Height [m], Wt: Weight [kg]
The expressions (2) and (3) are stored in the memory of the control means 55. For example, the data may be tabulated and the table may be stored.

(Prediction method for end condition 3)
The plasma collection amount A (predicted value) [mL] per cycle is the set plasma collection amount [mL] per cycle.

  As described above, the set plasma collection amount per cycle is set in advance to a predetermined value (for example, 250 mL), but can be changed by the operator by operating the touch panel 19. It has become.

  Next, the control operation of the control means 55 when setting the number of cycles for the plasma collection operation will be described.

  FIG. 3 is a flow chart for explaining the operation of the blood component collection device shown in FIG. 1. FIG. 3 shows the control operation of the control means 55 when setting the number of cycles of the plasma collection operation. Yes.

  As shown in FIG. 3, first, the count value (variable) N of the counter is initialized and set to 1 (N = 1) (step S101).

  Next, sex, height, weight, and hematocrit value (Hct) are input as information about the donor (step S102).

  Next, the target collection amount of plasma is input, and the target collection amount is set (step S103).

  Next, the amount of plasma collected per cycle when the termination condition 1 is satisfied and the plasma collection process is terminated is predicted using the “prediction method for the termination condition 1” described above (step S104).

  Next, the amount of plasma collected per cycle when the termination condition 2 is satisfied and the plasma collection process is terminated is predicted using the aforementioned “prediction method for the termination condition 2” (step S105).

  Next, the amount of plasma collected per cycle when the termination condition 3 is satisfied and the plasma collection process is terminated is predicted using the “prediction method for the termination condition 3” described above (step S106).

  Next, the minimum value among the predicted values for the end conditions 1 to 3 is selected (step S107).

  Next, the minimum value is added (totaled) up to the Nth cycle to obtain an added value (total value) (step S108). When N = 1, the minimum value in the first cycle is the added value.

  Next, it is determined whether or not the added value is equal to or greater than the target collected amount of plasma (step S109), and when it is determined that the added value is not equal to or greater than the target collected amount of plasma (the target collected amount has not been reached) The count value N is incremented by 1 (N = N + 1) (step S110), the process returns to step S104, and step S104 and subsequent steps are executed again.

  If it is determined in step S109 that the added value is equal to or greater than the target collection amount of plasma (having reached the target collection amount), the number of plasma collection operations is determined to be N (N cycles), and N (N cycles) ) Is set as the number of cycles for plasma collection operation (step S111).

  As described above, according to this blood component collection device 1, when the information on the donor and the target collection amount of plasma are input, the number of cycles of the plasma collection operation is automatically set. The operation (operation) is easy.

  In addition, since the number of plasma collection operations is determined based on the minimum of a plurality of predicted values of the amount of plasma collected per cycle, the number of plasma collection operations is insufficient and the target amount of plasma is reduced. It can be prevented that the sample cannot be collected. That is, the number of plasma collection operations can be accurately set, and a target amount of plasma can be reliably collected.

  The blood component collection device of the present invention has been described based on the illustrated embodiments. However, the present invention is not limited to this, and the configuration of each part is of any configuration having the same function. Can be substituted. In addition, any other component may be added to the present invention.

  In addition, the blood component collection device of the present invention is not limited to the application to obtain a plasma preparation, and may be applied to obtain, for example, a platelet preparation, a red blood cell preparation, a white blood cell preparation, etc. from blood. That is, in the blood component collection device of the present invention, the blood components collected in the blood component collection bag are not limited to plasma, but include, for example, platelets (platelets including plasma), red blood cells (red blood cells including plasma), white blood cells (plasma). White blood cells).

1 is a plan view (partly including a block diagram) showing an embodiment of a blood component collection device of the present invention. FIG. 2 is a partially broken cross-sectional view showing a state in which a centrifuge drive device is mounted on a centrifuge provided in the blood component collection device shown in FIG. 1. It is a flowchart for demonstrating the effect | action of the blood component collection device shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Blood component collection apparatus 2 Blood component collection circuit 10 Centrifuge drive device 11 Blood pump 12 Anticoagulant pump 14 Turbidity sensor 15 Optical sensor 151 Light projection part 152 Light reception part 153 Reflector plate 16 Weight sensor 17 1st bubble Sensor 19 Touch panel 20 Centrifuge 21 Blood collection / return line 21a Hollow needle side line 21b Centrifuge side line 21c Branch connector for connection 21d Chamber 21g Pump tube 21h Tube 21i Filter 22 Collection bag side line 23 Anticoagulant injection line 23a Pump tube 23c Bubble removal chamber 23d Anticoagulant fuser connection needle 24 Airbag side line 25 Plasma collection bag 26 Airbag 29 Hollow needle assembly 291 Hollow needle 292 Wing 293 Tube 32 Subbag 32a Tube 34 Second bubble sensor 35 Third bubble sensor 36 Fourth bubble sensor 37 Fifth bubble sensor 38 Connector 51 First channel opening / closing means 52 Second channel opening / closing means 55 Control means 61 Branch connector 62 Tube 63 Filter 64 Disinfection filter 131 Plasma layer 132 Blood cell layer 141 Tubing body 142 Rotor 143 Inlet 144 Outlet 145 Upper part 146 Blood storage space 147 Reflecting surface 153 Reflecting plate 201 Housing 202 Leg part 203 Motor 204 Rotating shaft 205 Fixed base 206 Bolt 207 Spacer S101 ~ S111 Step

Claims (5)

Blood collection means for collecting blood from a donor,
A centrifuge for centrifuging blood collected by the blood collection means;
A blood component collection circuit comprising a blood component collection bag for collecting a predetermined blood component separated by the centrifuge;
Blood that performs at least one cycle of blood component collection operation, which includes centrifugation of the collected blood to collect the predetermined blood component and a blood component return step of returning the remaining blood component to the donor A component collecting device,
When a plurality of end conditions for ending the blood component collection step are set and any one of the plurality of end conditions is satisfied, the blood component collection step is ended and the blood component return step is performed. Is composed of
Target sampling amount input means for inputting a target sampling amount of the predetermined blood component;
Target sampling amount setting means for setting the input target sampling amount;
Predicting means for predicting the amount of the predetermined blood component collected per cycle for each of the cases where the end conditions are satisfied and the blood component collecting step is terminated;
The prediction means on the basis of the minimum value of each prediction value predicted by, possess a number of cycles determining means for determining the number of cycles the blood component collection operation,
The predicting means sequentially predicts the amount of the predetermined blood component collected per cycle from the first cycle for each of the cases where the blood component collection step is completed by satisfying the termination conditions,
The cycle number determining means sequentially adds the minimum value from the first cycle, and the number of cycles when the added value is equal to or greater than the set target collection amount of the predetermined blood component. Is determined as the number of cycles of the blood component collection operation . Having blood donor information input means for inputting information about the blood donor,
For at least one of the end conditions, the prediction means inputs the sampling amount of the predetermined blood component per cycle when the end condition is satisfied and the blood component collecting step is ended. The blood component collection device according to claim 1, wherein the blood component collection device is configured to perform prediction based on information related to a blood donor. The blood component collection device according to claim 2 , wherein the information on the blood donor includes at least one of sex, height, weight, and hematocrit value. The plurality of end conditions include a case where blood cells flow out of the centrifuge, a case where the blood collection amount per cycle reaches an allowable extracorporeal blood circulation amount, and the amount of the predetermined blood component collected per cycle in advance. The blood component collection device according to any one of claims 1 to 3 , wherein at least one of a case where a set value is reached is included. The blood component collection device according to any one of claims 1 to 4 , wherein the predetermined blood component is plasma.

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