JP4783711B2 - Blood collection device - Google Patents

Description

  The present invention relates to a blood collection apparatus.

  Component blood collection is a procedure in which blood (whole blood) collected from a donor (donor) is separated into blood components by centrifugation or membrane separation, and the necessary blood components are collected and the remaining blood components are returned to the donor. is there. In the case of component blood collection using a centrifugal separation method, particularly a centrifugal bowl method, a method is adopted in which a blood collection step and a blood return step are alternately repeated with a single blood collection needle in order to reduce invasion to the donor.

  In normal component blood collection, in addition to alcohol sterilization, popidone iodine sterilization, etc., still, bacteria on the skin surface, hair follicles and under the skin may be mixed with blood components in the blood component collection bag. .

  Depending on the type of bacteria, the contaminated bacteria can grow while the blood component collection bag containing the blood components is stored, and if this blood component is used for transfusion without being aware of it, Patients may develop infections and sepsis.

  These bacteria are often found not only on the skin surface, but also in the roots of the hair roots and subcutaneously, so just before the blood is collected, simply disinfecting the puncture site of the blood collection needle will prevent the bacteria from entering the collected blood. It is difficult to avoid.

  Here, it has been empirically known that bacteria invade the collected blood first stream (primary blood collection) (mostly with a piece of skin).

  Then, in order to remove the initial blood collection flow, the blood component collection circuit of the blood component collection device branches from a branch portion provided in the blood processing line connecting the blood collection needle and the inlet of the blood separator, A blood component collection device provided with an initial flow collection line for collecting an initial flow has been proposed (see, for example, Patent Document 1). The initial flow collection line is provided with an initial flow collection bag for collecting the initial blood collection, and the initial flow collection bag is provided with a mark that serves as an index of the collection amount of the first blood collection (target collection amount). ing.

  When collecting the initial blood collection into the initial flow collection bag, the operator manually opens and closes a plurality of clamps (channel opening / closing means) according to a predetermined procedure, and sets each channel of the blood component collection circuit. Open or close.

  However, there is a possibility that the operator sometimes performs an erroneous operation such as wrong procedure for opening / closing the clamp or forgetting to close the clamp. As a result, for example, the initial blood collection flow may flow into the centrifuge, and bacteria may be mixed into the collected blood component (blood) during the main blood collection. Further, when collecting the initial blood collection, for example, it may be overlooked that the blood level in the initial flow collection bag reaches the marked line, and an excessive amount of the initial blood collection may be collected.

JP-T-2006-503650

  The object of the present invention is to allow the operator to easily and reliably perform the opening / closing operation of the channel opening / closing means during the initial flow collection operation, and to ensure the initial flow collection operation. An object of the present invention is to provide a blood collection device capable of preventing bacterial contamination and improving the safety when transfusion of a predetermined blood component or blood.

Such an object is achieved by the present inventions (1) to (34) below.
(1) a blood collection means equipped with a blood collection needle for collecting blood from a donor,
A blood collection bag for storing the blood collected by the blood collection means;
A blood collection circuit having an initial flow collection line for collecting an initial flow of blood collected from the blood donor;
Prior to the collection of blood into the blood collection bag, an initial flow collection operation is performed for collecting an initial flow of blood collected from the blood donor through the first flow collection line, and then blood from the blood donor to the blood collection bag is performed. A blood collection device for collecting
In the initial flow collection operation, a flow channel opening and closing means that opens and closes a predetermined flow channel of the blood collection circuit and is manually opened and closed;
Open / closed state detecting means for detecting the open / closed state of the flow path by the flow path opening / closing means;
Transmitting means for transmitting the detection result of the open / close state detecting means;
Receiving means for receiving information transmitted from the transmitting means;
Based on the information received by the receiving means, procedure information creating means for creating procedure information indicating a procedure including an opening / closing operation of the flow path opening / closing means in the initial flow sampling operation;
A blood collection device comprising: an informing means for informing the procedure information.

(2) blood collection means equipped with a blood collection needle for collecting blood from a donor,
A blood separator for separating blood collected by the blood collecting means;
A blood component collection bag for collecting a predetermined blood component separated by the blood separator;
A blood collection circuit having an initial flow collection line for collecting an initial flow of blood collected from the blood donor;
Prior to collection of the predetermined blood component, an initial flow collection operation is performed to collect an initial flow of blood collected from the donor through the initial flow collection line, and thereafter, blood collected from the donor is separated. A blood collection device for collecting the predetermined blood component,
In the initial flow collection operation, a flow channel opening and closing means that opens and closes a predetermined flow channel of the blood collection circuit and is manually opened and closed;
Open / closed state detecting means for detecting the open / closed state of the flow path by the flow path opening / closing means;
Transmitting means for transmitting the detection result of the open / close state detecting means;
Receiving means for receiving information transmitted from the transmitting means;
Based on the information received by the receiving means, procedure information creating means for creating procedure information indicating a procedure including an opening / closing operation of the flow path opening / closing means in the initial flow sampling operation;
A blood collection device comprising: an informing means for informing the procedure information.

(3) a blood collection means provided with a blood collection needle for collecting blood from a blood donor;
A blood separator for separating blood collected by the blood collecting means;
A blood component collection bag for collecting a predetermined blood component separated by the blood separator;
A blood treatment line connecting the blood collection needle and the inlet of the blood separator;
An anticoagulant injection line for injecting an anticoagulant, branched from a first branch portion provided in the blood treatment line;
An initial flow collection line for branching from a second branch portion provided between the blood collection needle and the first branch portion of the blood processing line and for collecting an initial flow of blood collected from the blood donor; A blood collection circuit having
An anticoagulant supply means for adding the anticoagulant to the blood collected by the blood collection means,
Prior to collection of the predetermined blood component, an initial flow collection operation is performed to collect an initial flow of blood collected from the donor through the initial flow collection line, and thereafter, blood collected from the donor is separated. A blood collection device for collecting the predetermined blood component,
In the initial flow collection operation, a flow channel opening and closing means that opens and closes a predetermined flow channel of the blood collection circuit and is manually opened and closed;
Open / closed state detecting means for detecting the open / closed state of the flow path by the flow path opening / closing means;
Transmitting means for transmitting the detection result of the open / close state detecting means;
Receiving means for receiving information transmitted from the transmitting means;
Based on the information received by the receiving means, procedure information creating means for creating procedure information indicating a procedure including an opening / closing operation of the flow path opening / closing means in the initial flow sampling operation;
A blood collection device comprising: an informing means for informing the procedure information.

(4) The blood collection circuit has an initial flow collection bag connected to the initial flow collection line and collecting the initial flow of blood,
The blood collection device comprises a blood volume detection means for detecting the volume of blood collected in the initial flow collection bag;
The blood collection device according to any one of (1) to (3), further including a transmission unit that transmits a detection result of the blood volume detection unit to the reception unit.

  (5) The blood collection device according to (4), wherein the blood volume detection means is provided in the initial flow collection bag.

  (6) The blood collection device according to (4) or (5), wherein the transmission unit that transmits the detection result of the blood volume detection unit is provided in the initial flow collection bag.

  (7) The blood collection unit according to any one of (4) to (6), wherein the blood volume detection means detects that the amount of blood collected in the initial flow collection bag has reached a predetermined level. apparatus.

(8) The blood volume detection means has a pair of terminals provided in the initial flow collection bag so as to be separated from each other, and a power supply unit, and the amount of blood collected in the initial flow collection bag When the predetermined amount is reached, the pair of terminals are conducted through the blood in the initial flow collection bag, and the conduction is detected.
When continuity between the pair of terminals is detected by the open / close state detection means, a predetermined signal indicating that the amount of blood collected in the initial flow collection bag has reached a predetermined amount is transmitted from the transmission means. The blood collection device according to any one of (4) to (6), configured as described above.

  (9) The blood collection device according to any one of (1) to (8), wherein the open / close state detection means is provided in the flow path opening / closing means.

  (10) The blood collection device according to any one of (1) to (9), wherein the transmission unit that transmits the detection result of the open / close state detection unit is provided in the flow path opening / closing unit.

(11) The flow path opening / closing means is provided at a plurality of locations of the blood sampling circuit,
The blood collection device according to any one of (1) to (10), wherein the open / close state detection means is provided in each of the flow path open / close means.

  (12) The blood collection device according to (11), wherein the transmission unit that transmits the detection result of the open / close state detection unit is provided in each of the channel opening / closing units.

(13) The notification unit includes a display unit that displays an electronic image.
Each of the channel opening / closing means is a clamp having different colors or a marker having markers different from each other,
In the initial flow sampling operation, the instruction of opening / closing operation of the clamp is displayed on the display unit in the color corresponding to the clamp performing the opening / closing operation as the procedure information (11). Or the blood collection apparatus as described in (12).

(14) The notification unit includes a display unit that displays an electronic image.
Each of the channel opening / closing means is a clamp having different colors or a marker having markers different from each other,
In the initial flow sampling operation, the instruction to open / close the clamp is displayed on the display unit as the procedure information in a color corresponding to the clamp performing the opening / closing operation and in an image of the clamp. The blood collection device according to (11) or (12) above.

(15) The flow path opening / closing means includes a pressure closing portion that press-closes a tube that forms a flow path of the blood sampling circuit, and an engagement portion that engages and maintains the pressure closed state of the pressure closing portion. Clemme that has
The open / closed state detection means has a pair of terminals that contact each other when the engagement portion of the clamp is engaged, and a power supply unit, and when the pair of terminals contact each other and become conductive, Configured to detect the continuity,
When the open / closed state detecting means detects the continuity of the pair of terminals, a predetermined signal indicating that the clamp is closed is transmitted from the transmitting means. 14) The blood collecting device according to any one of 14).

(16) The blood collection circuit has an initial flow collection bag connected to the initial flow collection line and collecting the initial flow of blood,
The blood collection device comprises a blood volume detection means for detecting the volume of blood collected in the initial flow collection bag;
Transmission means for transmitting the detection result of the blood volume detection means to the reception means,
As the channel opening / closing means, a first channel opening / closing member for opening / closing the channel of the initial flow collection line, and the channel of the blood processing line between the second branch portion and the blood collection needle are opened / closed. A second flow path opening / closing member, and a third flow path opening / closing member for opening / closing the flow path of the blood processing line between the first branch portion and the second branch portion are provided. ,
The blood collection device according to (3), wherein the open / close state detection means is provided in each of the first flow path opening / closing member, the second flow path opening / closing member, and the third flow path opening / closing member.

  (17) The blood collection device according to (16), wherein the blood volume detection means is provided in the initial flow collection bag.

  (18) The blood collection device according to (16) or (17), wherein the transmission unit that transmits the detection result of the blood volume detection unit is provided in the initial flow collection bag.

  (19) The blood collection unit according to any one of (16) to (18), wherein the blood volume detection means detects that the amount of blood collected in the initial flow collection bag has reached a predetermined level. apparatus.

(20) The blood volume detection means includes a pair of terminals provided in the initial flow collection bag so as to be separated from each other, and a power supply unit, and the amount of blood collected in the initial flow collection bag When the predetermined amount is reached, the pair of terminals are conducted through the blood in the initial flow collection bag, and the conduction is detected.
When continuity between the pair of terminals is detected by the open / close state detection means, a predetermined signal indicating that the amount of blood collected in the initial flow collection bag has reached a predetermined amount is transmitted from the transmission means. The blood collection device according to any one of (16) to (19), configured as described above.

  (21) The transmission means for transmitting the detection result of the open / close state detection means is provided in each of the first flow path opening / closing member, the second flow path opening / closing member, and the third flow path opening / closing member. The blood collection device according to any one of (16) to (20).

(22) In the initial flow collection operation, the first flow path opening / closing member is opened and the third flow path opening / closing member is closed. Collecting an initial flow of a predetermined amount of blood in the initial flow collection bag through a collection line, and closing the second flow path opening and closing member;
Opening the third flow path opening / closing member and operating the anticoagulant supply means causes the anticoagulant to flow through the anticoagulant injection line, the first branch part, and the second branch part to the initial flow. After performing the anticoagulant supply step of supplying the sampling line and closing the first flow path opening and closing member,
The blood collection device according to any one of (16) to (21), which is configured to open the second flow path opening / closing member.

  (23) In the initial flow collection operation, an instruction to open the second flow path opening / closing member is notified, the opening of the second flow path opening / closing member is detected, and the initial flow collection is performed. The blood collection according to (22), which is configured to notify an instruction to close the second flow path opening / closing member when it is detected that the initial flow of a predetermined amount of blood has been collected in the bag. apparatus.

  (24) In the initial flow sampling operation, when it is detected that the second flow path opening / closing member is closed, an instruction to open the third flow path opening / closing member is notified, and the third flow opening / closing member is notified. When it is detected that the flow path opening / closing member is opened, the anticoagulant supply means is operated, and the anticoagulant is passed through the anticoagulant injection line, the first branch portion, and the second branch portion. Is supplied to the initial flow collection line, and the blood collection device according to (23) is configured to notify an instruction to close the first flow path opening / closing member.

  (25) In the initial flow collection operation, when it is detected that the first flow path opening / closing member is closed, an instruction to open the second flow path opening / closing member is notified, and the second flow opening / closing member is notified. The blood collection device according to (24), wherein the predetermined blood component can be collected when it is detected that the flow path opening / closing member is opened.

  (26) In the initial flow collection operation, when it is detected that the first flow path opening / closing member is closed, an instruction to open the second flow path opening / closing member is notified, and the second flow opening / closing member is notified. The blood collection device according to (24), configured to start collecting the predetermined blood component when it is detected that the flow path opening / closing member is opened.

(27) The notification unit includes a display unit that displays an electronic image.
The first flow path opening / closing member, the second flow path opening / closing member, and the third flow path opening / closing member are each a clamp having different colors or a marker having different colors.
In the initial flow sampling operation, the instruction to open / close the clamp is displayed on the display unit in the color corresponding to the clamp performing the opening / closing operation as the procedure information (16). Thru | or the blood-collecting apparatus in any one of (26).

(28) The notification unit includes a display unit that displays an electronic image,
The first flow path opening / closing member, the second flow path opening / closing member, and the third flow path opening / closing member are each a clamp having different colors or a marker having different colors.
In the initial flow sampling operation, the instruction to open / close the clamp is displayed on the display unit as the procedure information in a color corresponding to the clamp performing the opening / closing operation and in an image of the clamp. The blood collection device according to any one of (16) to (26) above.

(29) The first flow path opening / closing member, the second flow path opening / closing member, and the third flow path opening / closing member are respectively closed by pressure to close a tube forming the flow path of the blood collection circuit. And an engagement part that engages and maintains the pressure-closed state of the pressure-closed part,
The open / closed state detection means has a pair of terminals that contact each other when the engagement portion of the clamp is engaged, and a power supply unit, and when the pair of terminals contact each other and become conductive, Configured to detect the continuity,
(16) to (16) configured such that when the open / closed state detecting means detects conduction of the pair of terminals, the transmitting means transmits a predetermined signal indicating that the clamp is closed. 28) The blood collecting device according to any one of 28).

  (30) The blood collecting apparatus according to any one of (16) to (29), wherein the anticoagulant supply means is a liquid feed pump installed in the anticoagulant injection line.

  (31) The blood collection device separates blood collected from a blood donor, collects the predetermined blood component, and has a blood component collection step that returns the remaining blood component to the blood donor. The blood collection device according to any one of (16) to (30), wherein the component collection operation is performed for at least one cycle.

(32) The receiving means is provided, and has an arm band to be worn on the blood donor's arm,
The blood collection apparatus according to any one of (1) to (31), wherein the information received by the receiving unit is configured to be transmitted from the receiving unit to the procedure information creating unit.

  (33) The blood collection device according to any one of (1) to (32), wherein communication between the transmission unit and the reception unit is performed wirelessly.

  (34) The blood collection device according to any one of (1) to (33), configured to execute the initial flow collection operation based on information received by the reception unit.

  According to the present invention, at the time of blood collection, it is possible to easily collect (remove) an initial flow (initial blood collection) that may cause bacterial infection from blood collected from a donor (donor). Thus, the contamination of bacteria into the collected blood and each blood component separated from the collected blood is suppressed, and safety is improved.

  In particular, during the initial flow collection operation, the open / close state detection means detects the open / close state of the flow path by the flow path opening / closing means, and based on the detection result, procedure information indicating the procedure in the initial flow collection operation is created, Since the notification is made, the operator can easily and surely perform the opening / closing operation of the channel opening / closing means. This ensures that the initial flow collection operation is performed.

Hereinafter, the blood collection device of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
The blood collection apparatus of the present invention has a blood collection circuit including a blood collection bag for storing (collecting) blood (whole blood) collected by the blood collection means, and the blood collection apparatus for collecting the whole blood and the blood collection means Blood component collection device that has a blood collection circuit that has a blood collection circuit that includes a blood component collection bag that collects a predetermined blood component separated by the blood separator, and a blood separator that collects blood collected by the blood separator In the following embodiments, a case where the blood collection device of the present invention is applied to a plasma collection device (blood component collection device) for collecting plasma will be described as a representative example.

  FIG. 1 is a plan view (partly including a block diagram) showing an embodiment in which the blood collection device of the present invention is applied to a blood component collection device for mainly collecting plasma, and FIG. 2 is shown in FIG. FIG. 3 is a front view showing an initial flow collection bag of the blood component collection device shown in FIG. 1. 4 is a perspective view showing the clamp of the blood component collection device shown in FIG. 1. FIG. 4 (a) shows an open state, and FIG. 4 (b) shows a closed state. Is shown. 5 is a diagram showing the armband of the blood component collection device shown in FIG. 1, wherein FIG. 5 (a) is a plan view and FIG. 5 (b) is a perspective view. For convenience of explanation, the upper side in FIG. 3 is referred to as “upper” and the lower side is referred to as “lower”.

  A blood component collection device (blood collection device) 1 shown in FIG. 1 includes a hollow needle (blood collection needle) (blood collection means for collecting blood from a donor) 291 that is punctured into a blood vessel of a donor (blood donor) and a collected blood. A centrifuge (centrifuge bowl) (blood separator) 20 that centrifuges in the blood storage space 146, and a plasma collection bag (blood component collection bag) 25 that collects plasma (blood components) separated by the centrifuge 20 A blood component collection circuit (blood processing circuit) 2 comprising: a blood sample collected from a donor is centrifuged, a predetermined amount of plasma is collected, and then, together with the remaining plasma, white blood cells, platelets and red blood cells (remaining blood components) ) To the donor (blood return).

  The blood component collection device 1 includes a hollow needle 291, a blood collection / return line (blood treatment line) 21 that serves as both a blood collection line and a blood return line, a centrifuge 20, and an outlet of the centrifuge 20. The collection bag side line 22 connected to 144, the anticoagulant injection line 23 and the initial flow collection line 27 connected in the middle of the blood collection / return line 21 and the collection bag side line 22 are connected in the middle. An air bag side line 24 communicating with the outlet 144 of the centrifuge 20 via the collection bag side line 22, a plasma collection bag (blood component collection bag) 25 connected to the collection bag side line 22, and a plasma collection bag 25, the sub bag 32 connected by the tube (flow path) 32a, the air bag 26 connected to the air bag side line 24, and the initial flow collection line 2 And a blood component collection circuit (blood collection circuit) 2 and a initial flow collection bag 81 connected with.

  In addition, the blood component collection device 1 includes a centrifuge drive device 10 for rotating the rotor 142 of the centrifuge 20 and a blood pump for feeding blood or blood components (liquid) in the blood collection / return line 21. (Liquid feed pump) (first liquid feed means) 11 and anticoagulant pump (liquid feed pump) for feeding anticoagulant (liquid) in the anticoagulant injection line 23 (second liquid feed means) ) 12, an air pump 56 for introducing (supplying) air to an arm band (a tourniquet) 7 to be mounted on the donor's arm, and a flow path for opening and closing the flow path of the blood component collection circuit 2 Control for controlling the opening / closing means 51 and the channel opening / closing means 52, the centrifuge drive device 10, the blood pump 11, the anticoagulant pump 12, the air pump 56, the channel opening / closing means 51, the channel opening / closing means 52 and the like. Means 55, turbidity sensor 14, optical Sensor 15, weight sensor 16, pressure sensor 18, first bubble sensor 17, second bubble sensor 34, third bubble sensor 35, fourth bubble sensor 36, and fifth bubble. A sensor 37 and a touch panel 19 are provided. The anticoagulant pump 12 constitutes an anticoagulant supply means for adding an anticoagulant to the collected blood.

Hereinafter, the structure of each part is demonstrated.
The hollow needle 291 is connected to one end of the blood collection / return line 21, and a wing 292 is provided on the proximal end side of the hollow needle 291. In FIG. 1, the hollow needle 291 is covered with a cap.

  The blood collection / return line 21 is disposed between the hollow needle side line 21a to which the hollow needle 291 is connected at one end and the centrifuge side line 21b to which the inlet 143 of the centrifuge 20 is connected. Pump tube 21g.

  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 is connected to the internal pressure of the hollow needle side line 21a (the internal pressure of the blood collection / return line 21 on the hollow needle 291 side from the blood pump 11), that is, the pressure sensor 18 for detecting the donor pressure.

  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 branch connector 21 c provided in the blood collection / return line 21. That is, the anticoagulant injection line (flow path) 23 branches from the branch connector (first branch portion) 21c, that is, branches from the blood collection / return line (flow path) 21 via the branch connector 21c. . The branch connector 21c is located (provided) in the vicinity of the hollow needle 291. 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 branch connector 21c side. In FIG. 1, the anticoagulant container connecting needle 23d is covered with a cap.

  The anticoagulant container connecting needle 23d of the anticoagulant injection line 23 is connected to a container (bag) (not shown) in which an anticoagulant (anticoagulant liquid) is housed (contained). As will be described later, the anticoagulant flows through the anticoagulant injection line 23 from the anticoagulant container connection needle 23d toward the branch connector 21c and is supplied (injected) to the hollow needle side line 21a. Thereby, for example, the anticoagulant can be added (mixed) to the blood collected by the hollow needle 291 via the anticoagulant injection line 23.

  In addition, although it does not specifically limit as an anticoagulant, For example, ACD-A liquid etc. can be used.

  One end of the initial flow collection line 27 is connected to a branch connector 21 e provided in the blood collection / return line 21. That is, the initial flow collection line (flow path) 27 branches from the branch connector (second branch portion) 21e, that is, branches from the blood collection / return line (flow path) 21 via the branch connector 21e. The branch connector 21e is located (provided) between the hollow needle 291 and the branch connector 21c.

  The initial flow collection bag 81 is a container for collecting (reserving) an initial flow (initial blood collection) of blood collected from a donor by a hollow needle 291. The other end of the initial flow collection line 27 is connected to the initial flow collection bag 81. In the initial flow collection operation (initial flow collection process, anticoagulant feeding process) described later, the initial flow collection bag 81 is arranged such that the initial flow collection line 27 side (upper side in FIG. 3) is on the upper side in the vertical direction. Set (installed).

  As shown in FIG. 3, the initial flow collection bag 81 is provided with a pair of terminals (electrodes) 45, an IC chip 41d having a transmission part (transmission means) 42d, an antenna 47, and a power supply part 48d. The IC chip 41d and the pair of terminals 45, the IC chip 41d and the antenna 47, and the IC chip 41d and the power supply unit 49d are electrically connected to each other.

  The pair of terminals 45 are installed on the upper part of the initial flow collection bag 81 so as to be separated from each other by a predetermined distance, the upper part being fixed to the upper part of the initial flow collection bag 81, and the lower part being the initial flow collection bag 81. Located in. In this case, the positional relationship between each terminal 45 and the initial flow collection bag 81 is that the amount of blood in the initial flow collection bag 81 reaches a predetermined amount (target amount) when an initial flow collection operation described later is performed. In other words, when the blood level of the blood in the initial flow collection bag 81 coincides with the marked line, it is preferable that both terminals 45 are conducted through the blood.

  It should be noted that both terminals 45 may be conducted shortly before the amount of blood in the initial flow collection bag 81 reaches a predetermined amount (target amount).

  Further, the IC chip 41d, the antenna 47, and the power supply unit 49d are respectively installed outside the initial flow collection bag 81.

  As shown in FIG. 2, the IC chip 41d includes a signal generation unit (not shown) that generates a signal having a predetermined frequency when the pair of terminals 45 are conductive, and the signal (detection result of the blood volume detection means). And a transmission unit (transmission means) 42d for transmitting (transmitting wirelessly) via the antenna 47. That is, the IC chip 41d does not transmit a signal when the pair of terminals 45 are non-conductive, generates a signal of a predetermined frequency when the pair of terminals 45 is conductive, and transmits the signal to the antenna 47. Send through. A signal (information) transmitted from the transmission unit 42d of the IC chip 41d is received by a reception unit (reception unit) 43 of the IC chip 41e provided on the armband 7 described later. Thus, communication between the transmission unit 42d of the IC chip 41d and the reception unit 43 of the IC chip 41e is performed wirelessly.

  As described above, the pair of terminals 45 and the signal generation unit of the IC chip 41d constitute blood volume detection means for detecting the volume of blood collected in the initial flow collection bag 81. These terminals 45 and signals The generator detects that the pair of terminals 45 are connected, that is, the amount of blood collected in the initial flow collection bag 81 has reached a predetermined amount (target amount), and the pair of terminals 45 is connected. When detected, a signal having a predetermined frequency indicating that the amount of blood collected in the initial flow collection bag 81 has reached a predetermined amount (target amount) is transmitted from the transmitter 42d.

  Note that the communication between the IC chip 41d of the initial collection bag 81 and the IC chip 41e of the armband 7 is not limited to wireless communication, and may be performed by wire, for example.

  Although the capacity | capacitance of the initial flow collection bag 81 is not specifically limited, It is preferable that it is about 10-100 mL, and it is more preferable that it is about 20-50 mL.

  If the capacity of the initial flow collection bag 81 is less than the above range, the initial flow of blood collected from the donor by the hollow needle 291 (initial blood collection flow) may not be sufficiently removed (collected). Exceeding this increases the amount of blood collected from the donor, increasing the burden on the donor.

  In addition, the initial flow collection bag 81 is preferably provided with a marked line (not shown) that serves as an index of the collection amount (target collection amount) of the initial blood collection. By providing the marked line, in the initial flow collection operation described later, the posture of the initial flow collection bag 81 is set so that the initial flow collection line 27 side is on the upper side in the vertical direction. By collecting blood until the surface matches the marked line, a target amount of blood can also be collected.

  A needle tube 83 is connected to the side of the initial flow collection bag 81 opposite to the connection portion of the initial flow collection line 27.

  An encapsulation member 84 that encapsulates the needle tube 83 is installed around the needle tube 83. As the encapsulating member 84, for example, a member made of a film made of various rubber materials (elastic material) and easily pierced by the needle tip of the needle tube 83 is preferably used.

  Further, a holder 85 having a cap 86 is attached to the proximal end side of the needle tube 83, whereby the needle tube 83 is accommodated in the holder 85. The holder 85 may be detachably attached to the needle tube 83.

  Further, in the middle of the initial flow collection line 27, a line (between the hollow needle 291 of the hollow needle side line 21a and the branch connector 21e, and between the branch connector 21e and the branch connector 21c of the hollow needle side line 21a, respectively. There are provided clamps (channel opening / closing means) 91, 92, and 93 that are opened and closed in the middle of the channel and are manually opened and closed. The clamp 91 is provided as a first channel opening / closing member (first channel opening / closing means) for opening and closing the channel (the channel in the tube) of the initial flow collection line 27. Further, the clamp 92 serves as a second flow path opening / closing member (second flow path opening / closing means), and the flow path (flow path in the tube) of the hollow needle needle line 21a between the hollow needle 291 and the branch connector 21e. It is provided to open and close. The clamp 93 serves as a third flow path opening / closing member (third flow path opening / closing means) between the branch connector 21e and the branch connector 21c, and the flow path of the hollow needle side line 21a (flow path in the tube). It is provided to open and close.

  Here, since the clamp 91 does not open again once it is closed at the time of collecting the components, the clamp 91 has a structure that does not open (difficult to open) once closed (difficult to open), for example, It is preferable to use a shutter clamp. For this reason, in this embodiment, a shutter clamp is used as the clamp 91.

  Moreover, it is preferable to use the clamps to which the clamps of different colors or the markers of different colors are attached, respectively. In the present embodiment, as the clamp 91, a blue clamp, a clamp 92, a red clamp, and a yellow clamp 93 are used.

  Thus, the operator (operator) can easily distinguish the clamps 91 to 93 by color (color difference).

  In addition, procedure information described later can be displayed on the touch panel 19 in a corresponding color (the color of the operation target clamp) in an easy-to-understand manner, so that the operator can easily and reliably determine which clamp is to be operated. I can grasp it.

  As shown in FIGS. 2 and 4, the clamp 91 includes an IC chip 41 a having a pair of terminals (electrodes) (not shown), a transmission unit (transmission means) 42 a, and an antenna (not shown). And a power supply unit 49a, the IC chip 41a and a pair of terminals, the IC chip 41a and the antenna, and the IC chip 41a and the power supply unit 49a are electrically connected to each other. Similarly, the clamp 92 includes a pair of terminals (electrodes) (not shown), an IC chip 41b having a transmission unit (transmission means) 42b, an antenna (not shown), and a power supply unit 49b. The IC chip 41b and the pair of terminals, the IC chip 41b and the antenna, and the IC chip 41b and the power supply unit 49b are electrically connected to each other. Similarly, the clamp 93 is provided with an IC chip 41c having a pair of terminals (electrodes) 44, a transmission unit (transmission means) 42c, an antenna 46, and a power supply unit 49c, and the IC chip 41c. The pair of terminals 44, the IC chip 41c and the antenna 46, and the IC chip 41c and the power source 49c are electrically connected to each other.

  Hereinafter, the clamp 93 will be described as a representative, and the description of the other clamps 91 and 92 will be omitted.

  As shown in FIG. 4, the overall shape of the clamp 93 is substantially U-shaped. And one front end side of the U-shape is curved, and a claw 931 is formed at the front end. Further, the other U-shaped portion is an operation portion 932, and the tip portion 933 of the operation portion 932 and the claw 931 can be engaged with each other.

  Further, inside the U-shape of the clamp 93, a pair of press-closing portions that oppose each other and press-close the tubes that form the flow path of the blood collection / return line 21 between the branch connector 21c and the branch connector 21e. 934 is formed.

  The claw 931 and the distal end portion 933 of the operation portion 932 constitute an engaging portion that maintains the pressure closed state of the pair of pressure closing portions 934.

  As shown in FIG. 4B, when the clamp 93 is grasped with a finger, the operation unit 932 is pushed into the claw 931 side, and the clamp 93 is closed, the tube is pressed and closed by a pair of pressure closing units 934. Is closed. When the distal end 933 of the operation unit 932 is hooked on the claw 931, the distal end 933 of the operation unit 932 and the claw 931 are engaged, and the pressure-closed state of the pair of pressure-closing portions 934 is maintained.

  Further, as shown in FIG. 4A, when the engagement between the tip 933 of the operation portion 932 and the claw 931 is released, the clamp 93 is opened by the restoring force of the clamp or the restoring force of the tube, and the flow path of the tube Is released.

  One of the pair of terminals 44 is installed on the proximal end side of the claw 931 of the clamp 93 and the other is installed on the distal end portion 933 of the operation unit 932.

  As a result, as shown in FIG. 4B, when the clamp 93 is closed (when the flow path is closed by the clamp 93), that is, the tip 933 and the claw 931 of the operation portion 932 of the clamp 93 When the are engaged, the pair of terminals 44 are in contact and conductive.

  Further, as shown in FIG. 4A, when the clamp 93 is open (when the flow path is opened by the clamp 93), that is, between the tip 933 of the operation portion 932 of the clamp 93 and the claw 931. When the engagement is disengaged, the pair of terminals 44 are separated and non-conductive.

  As shown in FIG. 2, the IC chip 41c includes a signal generation unit (not shown) that generates a signal having a predetermined frequency when the pair of terminals 44 are turned on, and the signal (detection result of the open / close state detection means). And a transmission unit (transmission means) 42c for transmitting (transmitting wirelessly) via the antenna 46. That is, the IC chip 41c does not transmit a signal when the pair of terminals 44 are non-conductive, and generates a signal of a predetermined frequency when the pair of terminals 44 is conductive, and the signal is transmitted to the antenna 46. Send through. The signal (information) transmitted from the transmission unit 42 c of the IC chip 41 c is received by the reception unit (reception unit) 43 of the IC chip 41 e provided in the armband 7. Thus, communication between the transmission unit 42c of the IC chip 41c and the reception unit 43 of the IC chip 41e is performed wirelessly.

  As described above, the pair of terminals 44 and the signal generation unit of the IC chip 41c constitute the open / close state detecting means for detecting the open / close state of the flow path by the clamp 93 (open / close state of the clamp 93). 44 and the signal generation unit detect the continuity of the pair of terminals 44. When the continuity of the pair of terminals 44 is detected, a signal having a predetermined frequency indicating that the clamp 93 is closed is transmitted from the transmission unit 42c. Send.

  The communication between the IC chip 41c of the clamp 93 and the IC chip 41e of the armband 7 is not limited to wireless, and may be performed by wire, for example.

  As described above, the clamp 93 is representatively described, but the other clamps 91 and 92 are also the same.

  The frequencies of signals transmitted from the IC chips 41a to 41d provided in the clamps 91 to 93 and the initial flow collection bag 81 are set to different values. Thereby, in the IC chip 41e of the control means 55 or the armband 7, it is determined whether the received signal is a signal transmitted from one of the clamps 91 to 93 or the initial flow collection bag 81 depending on the frequency of the signal. It can be distinguished (discriminated).

  When the clamps 91 and 92 are opened and the clamp 93 is closed, the initial flow of blood collected from the donor by the hollow needle 291 is separated from the hollow needle 291 by the donor's venous pressure or drop (self-weight). It flows through the line 21a, the branch connector 21e, and the initial flow collection line 27, and is introduced (collected) into the initial flow collection bag 81. That is, the initial flow (initial blood collection) of blood collected from the donor by the hollow needle 291 is removed from the hollow needle side line 21 a via the branch connector 21 e and the initial flow collection line 27, and is stored in the initial flow collection bag 81. Is collected. In this way, it is possible to easily remove (collect) the initial flow of the collected blood, which may cause bacterial infection, and thereby to the plasma (blood component) separated from the collected blood. The contamination of bacteria is suppressed and safety is improved.

  In addition, blood stored in the initial flow collection bag 81 can be collected (sampled) in a vacuum blood collection tube having a rubber stopper (not shown), for example.

  In this case, after closing the clamp 91, the cap 86 of the holder 85 is removed, and the decompression blood collection tube is inserted into the holder 85 from the rubber plug side, pushed into the innermost part of the holder 85, and the needle tube 83 is punctured into the rubber plug. Pierce. As a result, the blood stored in the initial flow collection bag 81 is sucked into the reduced pressure blood collection tube and collected. After the blood sampling into the reduced pressure blood collection tube is completed, the reduced pressure blood collection tube is pulled out from the holder 85. When blood is sampled into a plurality of decompression blood collection tubes, the above-described operation is repeated.

  The blood collected in the reduced-pressure blood collection tube can be used for, for example, serum biochemical tests, antibody tests for infectious disease viruses (for example, AIDS, hepatitis, etc.).

  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 for forming the blood collection / return line 21, collection bag side line 22, anticoagulant injection line 23, airbag side line 24 and initial flow collection line 27, pump tubes 21 g and 23 a, and subbag 32 As a constituent material of the connected tube 32a, the tube 21h connected to the chamber 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.

  Moreover, the same material as that of the tube can be used as the constituent material of the branch connectors 21c, 21e, and 61 described above.

  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. The sub bag 32 can be used, for example, for collecting air in the plasma collection bag 25.

  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.

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

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

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

  The centrifuge drive device 10 has a motor as a drive source and a disk-shaped fixed base that holds the centrifugal separator 20. When the motor is driven, the fixed base and the rotor 142 fixed thereto are It rotates on the predetermined centrifugation conditions (for example, rotation speed 3000-6000 rpm) set beforehand. 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 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, and the reflected light reflected by the reflecting surface of the rotor 142 is received by the light receiving unit. Then, it is converted into an electrical signal corresponding to the amount of received light in the light receiving unit.

  At this time, the projection light and the reflected light are transmitted through the blood component in the blood storage space 146, respectively, but depending on the position of the blood component interface (in this embodiment, the interface between the plasma layer and the blood cell layer), Since the abundance ratios of the blood components at the positions where the projected 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 varies (changes), and this variation can be detected as a change in the output voltage from the light receiving unit.

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

  Here, the plasma layer and the blood cell layer in the blood storage space 146 have different colors depending on the blood components, and the blood cell layer 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 the passage of air or bubbles, respectively. These prevent air from being injected into the donor.

  The second bubble sensor 34 is used to detect air (presence or absence of anticoagulant) at a predetermined position of the anticoagulant injection line 23 in order to detect that the anticoagulant injection line 23 is empty. .

  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.

  More specifically, 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 are ultrasonic waves from the outside of the tube, respectively. The gas and liquid (gas / liquid distinction, gas / liquid level, etc.) in the tube can be detected by utilizing the difference in ultrasonic conductivity between the liquid and bubbles (gas). It is a detection means. Note that each of these bubble sensors (gas and liquid detection means) is not limited to the ultrasonic sensor (ultrasonic sensor), and for example, an optical sensor or an infrared sensor may be used.

  As the turbidity sensor 14, for example, an ultrasonic sensor, an optical sensor, an infrared sensor, or the like can be used.

  As shown in FIG. 5, the arm band (cuff) (blood tourniquet) 7 includes a bag body 71 in which air is stored (introduced) and a cover 72 that covers the bag body 71. The cover 72 is provided with a magic tape (“magic tape” is a registered trademark), and the magic tape can be fixed in a state where the arm band 7 is wound around the donor's arm.

  Further, one end side of a tube 73 is connected to the bag body 71, and a connection portion (not shown) that is detachably connected to the air pump 56 is provided on the other end side of the tube 73. ing. Thereby, air can be introduced into the bag body 71 of the armband 7 by the operation of the air pump 56.

  The armband 7 is provided with an IC chip 41e having a receiving portion (receiving means) 43 and the like, and an antenna 48, and the IC chip 41e and the antenna 48 are electrically connected. The IC chip 41e and the antenna 48 are installed on the outer surface of the cover 72, respectively.

  Further, one end side of a cable 74 having a plurality of lines (conductive wires) is electrically connected to the IC chip 41e, and the other end side of the cable 74 is provided on the apparatus main body side having the control means 55 and the like. A connector (not shown) that is detachably connected to the connector (not shown) is provided. By connecting these connectors to each other, the control means 55 and the IC chip 41e of the armband 7 are electrically connected.

  Each line of the cable 74 is dedicated to transmitting (outputting) the detection results (information received by the receiving unit 43) in each of the clamps 91 to 93 and the initial flow collection bag 81 to the control means 55. A signal line and a power supply line (power line) are included. The power supply to the IC chip 41e of the armband 7 is performed from the apparatus main body side via the power line of the cable 74.

  As shown in FIG. 2, the IC chip 41 e has a receiving unit (receiving unit) 43, and each IC chip provided in each clamp 91 to 93 and the initial flow collection bag 81 by the receiving unit 43. The signals transmitted from the transmission units 42a to 42d of 41a to 41d are received via the antenna 48, respectively.

  For example, when a signal is transmitted from the IC chip 41c of the clamp 93 (when the clamp 93 is closed), the IC chip 41e directs a signal indicating that the clamp 93 is closed to the control means 55. When the signal is not transmitted from the IC chip 41c of the clamp 93 (when the clamp 93 is open), a signal indicating that the clamp 93 is open is output to the control means 55. The signal indicating that the clamp 93 is closed and the signal indicating that it is open are not particularly limited. As an example, one of the output levels may be a low level and the other may be a high level output.

The same applies to the other clamps 91 and 92.
Further, when a signal is transmitted from the IC chip 41d of the first flow collection bag 81, the IC chip 41e indicates that the amount of blood collected in the first flow collection bag 81 has reached a predetermined amount (target amount). When the signal shown is output to the control means 55 and no signal is transmitted from the IC chip 41d of the first flow collection bag 81, the amount of blood collected in the first flow collection bag 81 is a predetermined amount (target amount). A signal indicating that the signal has not been reached is output to the control means 55. The signal indicating that the amount of blood collected in the initial flow collection bag 81 has reached a predetermined amount (target amount) and the signal indicating that it has not reached are not particularly limited. As an example, one of the output levels may be a low level and the other may be a high level output.

  Note that communication between the IC chip 41e of the armband 7 and the control means 55 is not limited to wired communication, and may be performed wirelessly, for example.

  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, an air pump 56, a flow path opening / closing means 51, a flow path opening / closing means 52, turbidity. Degree 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, pressure sensor 18 and the touch panel 19 are electrically connected to each other. The control means 55 includes a calculation unit and a memory (both not shown).

  This control means 55 achieves (configures) the main function of the procedure information creation means for creating procedure information indicating procedures including the opening / closing operations of the respective clamps (channel opening / closing means) 91 to 93 in the initial flow sampling operation described later. The

  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. A color electronic image is displayed on the display unit of the touch panel. 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.

  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 pressure The detection signal from the sensor 18 and the signal from the IC chip 41e of the armband 7 are 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, 52 and the operation of the centrifuge drive device 10, the air pump 56, and the touch panel 19 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).

  Hereinafter, the usage method and operation of the blood component collection device 1 are described. Note that each step (operation) performed before the first cycle plasma collection operation (main blood collection) and the transition to the first cycle plasma collection operation (main blood collection) will be described in detail later.

  After completion of the anticoagulant feeding process, which will be described later, when the clamps 92 and 93 are opened and the clamp 91 is closed, the process proceeds to the first cycle plasma collection operation (main blood collection). A predetermined program is executed, and the first cycle of 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 collecting step, blood collection is started by rotating (forward rotation) the blood pump 11 clockwise (forward direction) in FIG. At the same time, the flow path opening / closing means 51 is opened, the flow path opening / closing means 52 is closed, and blood components in the blood storage space 146 of the centrifuge 20 are collected via the collection bag side line 22 and the air bag side line 24. The air in the circuit 2 (sterilized air) is transferred into the airbag 26 and stored.

  Simultaneously with the blood collection, the anticoagulant pump 12 is rotated (forward) in the counterclockwise direction (forward direction) in FIG. An anticoagulant is supplied, and this anticoagulant is added to the blood sample.

  As a result, blood (anticoagulant-added blood) is transferred via 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.

  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 from the inside into two layers, a plasma layer (PPP layer) and a blood cell layer.

  Furthermore, 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, and the plasma flows through the collection bag side line 22.

  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.

  Next, the flow path opening / closing means 51 is closed, the flow path opening / closing means 52 is opened, and the plasma in the blood storage space 146 of the centrifuge 20 is transferred into the plasma collection bag 25 via the collection bag side line 22. 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.

  When plasma collection is to be terminated, the operation of the blood pump 11 and the anticoagulant pump 12 is stopped, the channel opening / closing means 51 is opened, the channel opening / closing means 52 is closed, and the centrifuge drive device 10 is activated. 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 proceeds to the blood cell return process (blood return). In this blood cell 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, the blood pump 11 is rotated (reversed) counterclockwise (reverse direction) in FIG.

  As a result, the remaining blood components in the blood storage space 146 of the centrifuge 20 are returned to the donor via the centrifuge side line 21b, the hollow needle side line 21a, and the hollow needle 291.

  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 controlled by the control means 55 prior to the main blood collection, that is, the plasma collection step of the first cycle (collection of plasma (blood component) into the plasma collection bag 25). An initial flow collection operation (initial flow collection step, anticoagulant feeding step) for collecting an initial flow of blood collected from a donor through the collection line 27 (initial flow of blood collection) into the first flow collection bag 81 is performed. This blood collection, that is, the plasma collection step of the first cycle is performed.

  In each step (each operation) before the main blood collection (plasma collection step in the first cycle), in particular, in the initial flow collection operation, the open / close state of the flow path by each clamp 91-93 (open / close of each clamp 91-93). State) and the amount of blood collected in the initial flow collection bag 81 (for example, whether or not a predetermined amount (target amount) has been reached) is detected, and these detection results (information received by the receiving unit 43) are detected. Based on this, procedure information indicating a procedure including an opening / closing operation of each clamp 91-93 in the initial flow sampling operation (for example, an instruction to open / close each clamp 91-93) is created, and this procedure information is displayed on the touch panel 19. In addition, each step before the main blood collection such as the initial flow collection operation is executed.

  Also, on the touch panel 19, as the procedure information, the opening / closing operation instructions of each of the clamps 91 to 93 are the colors of the operation target clamps (colors corresponding to the clamps performing the opening / closing operation) and the images of the clamps. Is displayed.

  Hereinafter, based on FIG. 6 and FIG. 7, the process before the main blood collection, that is, the above-described first cycle plasma collection operation will be described.

  6 and 7 are flowcharts for explaining the operation of the blood component collection device shown in FIG. 1 (flowchart showing the control operation of the control means 55), and FIG. 8 is an initial flow of the blood component collection device shown in FIG. It is a figure which shows the structural example of a collection screen.

  First, the operator connects an anticoagulant bag (not shown) containing an anticoagulant to the anticoagulant line 23, and fills the anticoagulant with about 1/3 of the bubble removing chamber (drip tube) 23c. Hang the anticoagulant bag on a hanger (not shown). Further, the clamps 92 and 93 are closed, and only the clamp 91 is opened.

  Then, the operator presses a priming start button (priming start switch) displayed on the touch panel 19. Thereby, a priming process (priming operation) is started.

  In the priming step, the anticoagulant pump 12 is rotated in the forward direction to prime the coagulant injection line 23 and the branch connector 21c of the hollow needle side line 21a to the chamber 21d with the anticoagulant. When all of the bubble sensors 34, 36, and 37 detect the anticoagulant, priming is completed and the anticoagulant pump 12 is stopped.

  When the priming process ends, the process moves to the initial flow collection operation (initial flow collection process of the initial flow collection operation), and the programs shown in FIGS. 6 and 7 are executed.

First, the initial flow collection screen is displayed on the touch panel 19 (step S101).
On the initial flow collection screen in step S101, an instruction (procedure) to open the red clamp 92 is displayed. Specifically, for example, as shown in FIG. 8, the closed state and the opened state are displayed in red, which is the color of the operation-targeted state 92, and between these points, An arrow pointing from the closed clamp to the open clamp is displayed.

  In addition, the initial flow collection screen in step S101 includes, for example, other open / close states of the other clamps 91 and 93, that is, the clamp 91 is in an open state, the clamp 93 is in a closed state, etc. May be displayed. This is the same in the related steps described below.

  Here, the operator originally punctures the donor's blood vessel with the hollow needle 291 and opens the clamp 92.

  Thereby, the initial flow of blood collected from the donor by the hollow needle 291 (initial blood flow) is the hollow needle 291, the hollow needle side line 21a, the branch connector 21e, the initial flow due to the donor's venous pressure and drop (self-weight). It flows through the flow collection line 27 and is introduced (collected) into the initial flow collection bag 81.

  In addition, you may comprise so that the liquid feeding to the first flow collection bag 81 of a blood collection initial flow may be performed with a pump.

  Next, based on the signal (information) transmitted from the IC chip 41b of the red clamp 92, it is determined whether or not the clamp 92 has been opened based on the signal output from the IC chip 41e of the armband 7 (step S102). ), When the clamp 92 is opened, the initial flow collecting screen is displayed on the touch panel 19 (step S103).

  In the initial flow collecting screen in step S103, for example, information indicating that the initial blood collection is being collected or “If the initial blood collection is completed without leaving this place, the clamp 92 is immediately closed. The operator's procedure such as “Please” is displayed.

  Next, based on a signal (information) transmitted from the IC chip 41 d of the first flow collection bag 81 and based on a signal output from the IC chip 41 e of the armband 7, a predetermined amount of blood is collected in the first flow collection bag 81. It is determined whether or not (target amount) has been collected (step S104). If a predetermined amount has been collected, an initial flow collection screen is displayed on the touch panel 19 (step S105).

On the initial flow collection screen in step S105, an instruction to close the red clamp 92 is displayed. Specifically, for example, a closed clamp and an open clamp are displayed in red, which is the color of the operation target clamp 92, and the open clamp is closed between these clamps. An arrow pointing in the direction of the clamp is displayed.
Here, the operator originally closes the clamp 92.

  Next, it is determined whether or not a predetermined time has passed (step S106). If the predetermined time has not passed, the armband 7 is checked based on the signal (information) transmitted from the IC chip 41b of the red clamp 92. Based on the signal output from the IC chip 41e, it is determined whether or not the clamp 92 is closed (step S107). If the clamp 92 is closed, the process proceeds to step S110.

  On the other hand, if the clamp 92 is not closed in step S107, the process returns to step S106, and step S106 and subsequent steps are executed again.

  If a predetermined time has elapsed in step S106, a nurse call process is performed (step S108).

  In the nurse call process of step S108, for example, a warning that an initial blood collection is excessively collected is given by sound such as a buzzer (not shown) or light emission (light) of the light emitting unit, and the nurse call is displayed on the touch panel 19. Display the reset button (nurse call reset switch).

  Here, the operator originally closes the clamp 92 and presses the nurse call reset button displayed on the touch panel 19.

  Next, it is determined whether or not the nurse call reset button has been pressed. If it has been pressed, the process returns to step S106, and step S106 and subsequent steps are executed again.

In step S <b> 110, the initial flow collection screen is displayed on the touch panel 19.
On the initial flow collection screen in step S110, an instruction to open the yellow clamp 93 is displayed. Specifically, for example, a closed state and an open state are displayed in yellow, which is the color of the operation target, and the closed state is opened from the closed state. An arrow pointing in the direction of the clamp is displayed.

  Here, the operator originally opens the clamp 93. The operation of opening the clamp 93 is an anticoagulant feeding process.

  Next, based on the signal (information) transmitted from the IC chip 41c of the yellow clamp 93, it is determined whether or not the clamp 93 has been opened based on the signal output from the IC chip 41e of the armband 7 (step S111). ) When the clamp 93 is opened, an anticoagulant liquid feeding screen is displayed on the touch panel 19 (step S112).

  On the anticoagulant feeding screen in step S112, for example, information indicating that the anticoagulant feeding is in progress is displayed.

  Next, the anticoagulant pump 12 is rotated (forward rotation) a predetermined number of times (for example, one rotation) in the forward direction (step S113).

  As a result, the anticoagulant flows from the branch connector 21c through the hollow needle side line 21a, the branch connector 21e, and the initial flow collection line 27 (supplied to the initial flow collection line 27). Then, the flow path from the branch connector 21c to the branch connector 21e of the hollow needle side line 21a and from the branch connector 21e of the initial flow collection line 27 to the middle thereof is filled (washed) with the anticoagulant.

Next, the initial flow collection screen is displayed on the touch panel 19 (step S114).
On the initial flow collection screen in step S114, an instruction to close the blue clamp 91 is displayed. Specifically, for example, a closed clamp and an open clamp are displayed in blue, which is the color of the operation target clamp 91, and the closed clamp is closed from the opened clamp. An arrow pointing in the direction of the clamp is displayed.

  Here, the operator originally closes the clamp 91. By the operation of closing the clamp 91, as will be described later, the display screen of the touch panel 19 is switched, and the anticoagulant feeding process is completed.

  Next, based on a signal (information) transmitted from the IC chip 41a of the blue clamp 91, it is determined whether or not the clamp 91 is closed based on a signal output from the IC chip 41e of the armband 7 (step S115). ) When the clamp 91 is closed, a blood collection start screen is displayed on the touch panel 19 (step S116).

  On the blood collection start screen in step S116, an instruction to open the red clamp 92 is displayed. Specifically, for example, a closed clamp and an open clamp are displayed in red, which is the color of the operation target clamp 92, and the closed clamp is opened between these clamps. An arrow pointing in the direction of the clamp is displayed.

Here, the operator originally opens the clamp 92.
Next, based on the signal (information) transmitted from the IC chip 41b of the red clamp 92, it is determined whether or not the clamp 92 has been opened based on the signal output from the IC chip 41e of the armband 7 (step S117). ), When the clamp 92 is opened, the process proceeds to the main blood collection, and the main blood collection, that is, the first cycle plasma collection operation described above is started.

  As described above, according to this blood component collection device 1, it is possible to easily remove an initial flow (blood collection initial flow) that may cause bacterial infection from blood collected from a donor during blood collection. Thus, contamination of bacteria in the collected plasma is suppressed, and safety when a predetermined blood component (for example, plasma) is transfused into the patient is improved. In addition, the removed blood collection initial flow can be stored in the initial flow collection bag 81.

  In particular, at the time of initial flow collection operation, the open / close state of the flow path by each clamp 91-93 (open / close state of each clamp 91-93) and the amount of blood collected in the initial flow collection bag 81 (a predetermined amount has been reached). And the procedure information of the initial flow sampling operation such as instructions for opening and closing the clamps 91 to 93 is created and displayed on the touch panel 19 based on the detection results. And the opening / closing operation | movement of the clamps 91-93 can be performed reliably. Thereby, the initial flow collection operation can be performed reliably. Further, the operator can reliably collect the initial amount of blood collection in the initial flow collection bag 81 without excess or deficiency without mistaken (missing) the timing of closing the clamp 92.

  Also, as each clamp 91-93, a different color clamp (or a clamp marked with a different color marker) is used, and on the touch panel 19, instructions for opening / closing the clamps 91-93 are respectively displayed. Since it is displayed in the color of the operation target Clemme and the image of the Clenme, the operator can easily and surely know which Clemme should be operated (open or closed) It is possible to open and close the clamps 91 to 93 easily and reliably.

  In addition, when it is determined in step S117 that the clamp 92 is opened, the plasma collection operation of the first cycle is automatically started, so that the operation performed by the operator can be reduced and the labor of the operator is reduced. can do.

  In the above-described embodiment, among the clamps 91 to 93, only the clamp for which the opening / closing operation is instructed is detected, and it is determined (determined) whether the open / close state is appropriate. However, the present invention is not limited to this, and for example, it may be configured to detect the open / close state of all the clamps 91 to 93 and determine whether the open / close state is appropriate. Good.

  For example, between step S101 and step S102, it is determined whether the blue clamp 91 is open and the yellow clamp 93 is closed. A predetermined warning may be given. The same applies to other locations. In this case, the initial flow collection operation can be performed more reliably.

  In the above embodiment, the plasma collecting operation of the first cycle is automatically started when it is determined in step S117 that the clamp 92 has been opened. For example, when it is determined in step S117 that the clamp 92 has been opened, the first cycle of the plasma collection operation may be configured. In this case, for example, when it is determined in step S117 that the clamp 92 has been opened, a blood collection start button (blood collection start switch) is displayed on the touch panel 19, and when the operator presses the blood collection start button, plasma in the first cycle is displayed. A collection operation can be configured to start.

  Further, in the present invention, the linking information for linking the apparatus main body provided with the control means 55 and the like to the blood component collection circuit 2 is displayed, for example, immediately before the hollow needle 291 is punctured into the donor. To 93 and the IC chips 41a to 41d (not shown) of the arm band 7 are stored in a memory (not shown), respectively, and the detection results are obtained from the respective clamps 91 to 93 and the IC chips 41a to 41d of the arm band 7 respectively. You may comprise so that it may be transmitted to the control means 55 via the IC chip 41e of the armband 7 with the tied information.

  Examples of the association information include the sex, height, weight, blood collection number, ID (model, serial number, etc.) of the apparatus main body.

  The control means 55 on the apparatus main body side detects the detection results from the IC chips 41a to 41d of the clamps 91 to 93 and the armband 7 in the blood component collection device 1 other than the blood component collection device 1 based on the association information. Distinguish from detection results.

  According to this, even when a plurality of blood component collection devices 1 are arranged close to each other, each blood component collection device 1 can reliably perform the initial flow collection operation.

  As mentioned above, although the blood collection apparatus of this invention was demonstrated based on embodiment of illustration, this invention is not limited to this, The structure of each part is substituted by the thing of the arbitrary structures which have the same function. be able to. Moreover, other arbitrary structures and processes may be added to the present invention.

  In the present invention, the receiving means is not limited to the armband, but may be provided in another part (for example, an apparatus main body provided with the control means).

  Further, the means for detecting the open / closed state of the flow path opening / closing means is not limited to that of the above-described embodiment, for example, it is configured by using a pressure sensor or the like, and the tightening force when the flow path opening / closing means is closed, etc. You may come to detect.

  Further, the notification means is not limited to a display means such as a touch panel, but may be a means for transmitting procedure information by voice or the like.

  In addition, the present invention is not limited to the case where it is applied to obtain a plasma preparation (or a raw material plasma of a plasma fractionation preparation), but is applied, for example, to obtain a platelet preparation, erythrocyte preparation, leukocyte preparation, etc. from blood. May be. That is, in the present invention, 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 (white blood cells including plasma), and the like. There may be.

  Further, the present invention may be configured to have a plurality of blood component collection bags and collect a plurality of blood components.

  Further, in the above-described embodiment, the case where the present invention is applied to a so-called intermittent type (also referred to as a single-needle type or one-arm type) blood collection device in which a blood collection line and a blood return line are integrated has been described. For example, the present invention can be applied to a so-called continuous type (also referred to as a two-needle type or double-arm type) blood collection device in which a blood collection line and a blood return line are separately provided.

  The present invention can also be applied to a blood collection device that collects predetermined blood components and does not return the remaining blood components to the donor.

  The present invention can also be applied to a blood collection device that collects blood (whole blood) collected from a donor in a blood collection bag. In this case, the procedure may be indicated by a color indicator such as an LED having the same color as the clamp without providing a display.

  In the present invention, the optical sensor is not limited to the illustrated one, and may be a line sensor, for example.

  In the present invention, the blood separator is not limited to the centrifugal type, and may be, for example, a membrane type.

FIG. 3 is a plan view (partly including a block diagram) showing an embodiment when the blood collection device of the present invention is applied to a blood component collection device that mainly collects plasma. It is a block diagram which shows the circuit structure of the blood component collection device shown in FIG. It is a front view which shows the first flow collection bag of the blood component collection device shown in FIG. It is a perspective view which shows the clamp of the blood component collection device shown in FIG. It is the top view and perspective view which show the arm band of the blood component collection device shown in FIG. It is a flowchart for demonstrating the effect | action of the blood component collection device shown in FIG. It is a flowchart for demonstrating the effect | action of the blood component collection device shown in FIG. It is a figure which shows the structural example of the first flow collection screen of the blood component collection apparatus shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Blood component collection device 2 Blood component collection circuit 10 Centrifuge drive device 11 Blood pump 12 Anticoagulant pump 14 Turbidity sensor 15 Optical sensor 16 Weight sensor 17 First bubble sensor 18 Pressure sensor 19 Touch panel 20 Centrifuge 21 Blood collection / return line 21a Hollow needle side line 21b Centrifuge side line 21c Branch connector 21d Chamber 21e Branch connector 21g Pump tube 21h Tube 21i Filter 22 Collection bag side line 23 Anticoagulant injection line 23a Pump tube 23c For removing air bubbles Chamber 23d Anticoagulant welder connection needle 24 Airbag side line 25 Plasma collection bag 26 Airbag 27 Initial flow collection line 291 Hollow needle 292 Wing 32 Subbag 32a Tube 34 Second bubble cell SA 35 Third bubble sensor 36 Fourth bubble sensor 37 Fifth bubble sensor 41a-41e IC chip 42a-42d Transmitter 43 Receiver 44, 45 Terminal 46, 47, 48 Antenna 49a-49e Power supply 51, 52 Flow path opening / closing means 55 Control means 56 Air pump 61 Branch connector 62 Tube 63 Filter 64 Disinfection filter 7 Armband 71 Bag body 72 Cover 73 Tube 74 Cable 81 Initial flow collection bag 83 Needle tube 84 Encapsulating member 85 Holder 86 Cap 91-93 Clemme 931 Claw 932 Operation part 933 Tip part 934 Pressure closing part 142 Rotor 143 Inlet 144 Outlet 145 Upper part 146 Blood storage space S101 to S117 Steps

Claims (8)

A blood collection means comprising a blood collection needle for collecting blood from a donor,
A blood collection bag for storing the blood collected by the blood collection means;
A blood collection circuit having an initial flow collection line for collecting an initial flow of blood collected from the blood donor;
Prior to the collection of blood into the blood collection bag, an initial flow collection operation is performed for collecting an initial flow of blood collected from the blood donor through the first flow collection line, and then blood from the blood donor to the blood collection bag is performed. A blood collection device for collecting
In the initial flow collection operation, a flow channel opening and closing means that opens and closes a predetermined flow channel of the blood collection circuit and is manually opened and closed;
Open / closed state detecting means for detecting the open / closed state of the flow path by the flow path opening / closing means;
Transmitting means for transmitting the detection result of the open / close state detecting means;
Receiving means for receiving information transmitted from the transmitting means;
Based on the information received by the receiving means, procedure information creating means for creating procedure information indicating a procedure including an opening / closing operation of the flow path opening / closing means in the initial flow sampling operation;
A blood collection device comprising: an informing means for informing the procedure information. A blood collection means comprising a blood collection needle for collecting blood from a donor,
A blood separator for separating blood collected by the blood collecting means;
A blood component collection bag for collecting a predetermined blood component separated by the blood separator;
A blood collection circuit having an initial flow collection line for collecting an initial flow of blood collected from the blood donor;
Prior to collection of the predetermined blood component, an initial flow collection operation is performed to collect an initial flow of blood collected from the donor through the initial flow collection line, and thereafter, blood collected from the donor is separated. A blood collection device for collecting the predetermined blood component,
In the initial flow collection operation, a flow channel opening and closing means that opens and closes a predetermined flow channel of the blood collection circuit and is manually opened and closed;
Open / closed state detecting means for detecting the open / closed state of the flow path by the flow path opening / closing means;
Transmitting means for transmitting the detection result of the open / close state detecting means;
Receiving means for receiving information transmitted from the transmitting means;
Based on the information received by the receiving means, procedure information creating means for creating procedure information indicating a procedure including an opening / closing operation of the flow path opening / closing means in the initial flow sampling operation;
A blood collection device comprising: an informing means for informing the procedure information. A blood collection means comprising a blood collection needle for collecting blood from a donor,
A blood separator for separating blood collected by the blood collecting means;
A blood component collection bag for collecting a predetermined blood component separated by the blood separator;
A blood treatment line connecting the blood collection needle and the inlet of the blood separator;
An anticoagulant injection line for injecting an anticoagulant, branched from a first branch portion provided in the blood treatment line;
An initial flow collection line for branching from a second branch portion provided between the blood collection needle and the first branch portion of the blood processing line and for collecting an initial flow of blood collected from the blood donor; A blood collection circuit having
An anticoagulant supply means for adding the anticoagulant to the blood collected by the blood collection means,
Prior to collection of the predetermined blood component, an initial flow collection operation is performed to collect an initial flow of blood collected from the donor through the initial flow collection line, and thereafter, blood collected from the donor is separated. A blood collection device for collecting the predetermined blood component,
In the initial flow collection operation, a flow channel opening and closing means that opens and closes a predetermined flow channel of the blood collection circuit and is manually opened and closed;
Open / closed state detecting means for detecting the open / closed state of the flow path by the flow path opening / closing means;
Transmitting means for transmitting the detection result of the open / close state detecting means;
Receiving means for receiving information transmitted from the transmitting means;
Based on the information received by the receiving means, procedure information creating means for creating procedure information indicating a procedure including an opening / closing operation of the flow path opening / closing means in the initial flow sampling operation;
A blood collection device comprising: an informing means for informing the procedure information. The blood collection circuit is connected to the initial flow collection line and has an initial flow collection bag for collecting the initial flow of blood,
The blood collection device comprises a blood volume detection means for detecting the volume of blood collected in the initial flow collection bag;
The blood collection apparatus according to claim 1, further comprising: a transmission unit that transmits a detection result of the blood volume detection unit to the reception unit.   The blood collection device according to any one of claims 1 to 4, wherein the open / close state detecting means is provided in the flow path opening / closing means.   The blood collection device according to any one of claims 1 to 5, wherein the transmission means for transmitting the detection result of the open / close state detection means is provided in the flow path opening / closing means. The channel opening / closing means is provided at a plurality of locations of the blood sampling circuit,
The blood collection device according to any one of claims 1 to 6, wherein the open / close state detection means is provided in each of the flow path open / close means. The receiving means is provided, and has an arm band to be worn on the blood donor's arm,
The blood collection apparatus according to any one of claims 1 to 7, wherein the information received by the receiving means is configured to be transmitted from the receiving means to the procedure information creating means side.

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