JP2007175534A - Instrument for blood-collecting - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an instrument for blood-collecting which is easily operated, prevents the bacterial contamination of collected blood, and can improve safety as well as collect blood for inspection in a good status. <P>SOLUTION: The instrument 1 for blood-collecting has a blood-collecting bag 10, a blood-collecting needle 152, and a tube 15 connected to them. A bifurcation connector 92 is formed in the middle of the tube 15 and the one end of a tube 91 is connected to the bifurcation connector 92. A bag 20, which temporarily contains the blood, is connected to the other end of the tube 91. Moreover, the one end of a tube 96 is connected to the bag 20 and a sampling port 71 is installed in the other end of the tube 96. A clamp 16 is formed in the tube 15 and a sealing member 93 and a clamp 95 are formed in the tube 91. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a blood collection device.

  In normal blood collection (operation for introducing blood collected from a blood collection needle into a blood bag (blood collection bag)), alcohol disinfection is performed, but bacteria that are present on the skin or subcutaneously still remain in the blood bag along with the blood. May be mixed in.

  Depending on the type of bacteria, the contaminated bacteria grow even while the blood bag containing the collected blood is refrigerated, and if this blood is used for transfusion without being aware of it, it will be transfused. Patients may develop infections and sepsis.

  Unlike currently used blood storage solutions (anticoagulants such as ACD-A solution and CPD solution), red blood cell storage solutions (SAGM solution, OPTISOL solution, MAP solution, etc.) currently used have a relatively neutral pH. Therefore, the tendency of bacterial growth during refrigeration is strong.

  Since these bacteria often squeeze not only on the skin surface but also subcutaneously, it is difficult to avoid invasion of the collected blood just by disinfecting the blood sampling puncture site immediately before blood collection. .

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

  However, there is still no blood bag or blood collection device that can remove this initial blood collection (see, for example, Patent Document 1).

JP-A-2-167173

  An object of the present invention is to provide a blood collection device that is simple in operation, prevents bacterial contamination of collected blood, can improve safety, and can collect blood for testing in a good state. There is to do.

Such an object is achieved by the present inventions (1) to (12) below.
(1) a blood collection needle for collecting blood from a donor;
A blood collection bag for storing blood collected from the blood collection needle;
A first tube having one end communicating with the blood collection bag and the other end communicating with the blood collection needle, respectively, and introducing the collected blood from the blood collection needle into the blood collection bag;
Branching from the first tube via the branching section, and having a storage section for temporarily storing blood, and a second tube having a blood outlet port stored in the storage section,
Before collecting the blood collected from the blood collection needle into the blood collection bag, the initial flow of the blood is introduced into the second tube and introduced into the storage unit, and then stored in the storage unit. A blood collection device for collecting the collected blood through the outlet,
The second tube is branched from the branch portion so that an angle formed by the first tube and the second tube between the blood collection needle and the branch portion is an acute angle. A blood sampling device characterized by

  (2) The blood collection device according to (1), wherein the storage unit is a bag body made of a resin sheet material having flexibility.

  (3) The blood collection device according to (1) or (2), wherein the storage unit has a capacity of 10 to 100 ml.

  (4) The blood collection instrument according to any one of (1) to (3), wherein the storage unit is provided in the vicinity of the extraction port.

  (5) Said (1) thru | or (4) which has the 1st flow-path sealing means which can open | release from the state which interrupted | blocked the flow path in the said 1st tube between the said branch part and the said blood collection bag. A blood collection device according to any one of the above.

  (6) The blood collection device according to (5), wherein the first flow path sealing means is a breakable sealing member that opens the flow path in the first tube when it is broken.

  (7) Said (1) thru | or (6) which has the sealing means for 2nd flow paths which can interrupt | block from the state which open | released the flow path in the said 2nd tube between the said branch part and the said accommodating part. A blood collection device according to any one of the above.

  (8) Any of the above (1) to (7), wherein the second tube has a backflow prevention means that allows a flow from the branch portion to the storage portion and prevents a flow in the reverse direction. The blood collecting device described in 1.

  (9) The second tube includes a tube having one end connected to the branch portion and the other end connected to one end side of the storage portion, and the takeout port is provided on the other end side of the storage portion. The blood collection device according to any one of (1) to (8) above.

  (10) The blood collection device according to any one of (1) to (9), wherein the extraction port is provided at an end of the second tube.

  (11) The flow path of the second tube is any one of the above (1) to (10), wherein an area of a cross section is set smaller than an area of a cross section of the flow path of the first tube. The blood sampling device described.

  (12) The blood collection instrument causes the initial flow of blood collected from the blood collection needle to flow into the second tube, introduces a predetermined amount into the storage unit, and then collects the blood into the blood collection bag In parallel with this, the blood collection device according to any one of (1) to (11) above, wherein the blood stored in the storage unit is collected through the outlet.

  According to the blood collection instrument of the present invention, the second tube is separated from the branch portion so that the angle formed by the first tube and the second tube between the blood collection needle and the branch portion becomes an acute angle. Operation is easy because it is branched.

  In addition, since the second tube has a storage portion for temporarily storing blood, the initial blood collection may remain on the blood collection bag side at the branch portion of the first tube and the second tube. In addition, the initial blood collection can be easily and reliably removed from the collected blood. Thereby, contamination of bacteria into the collected blood and each blood component separated from the collected blood is prevented, and the safety is improved.

  In addition, when sampling blood (when collecting blood for examination), it is possible to prevent an excessive load on the blood (for example, preventing damage to blood cells typified by hemolysis). Thereby, blood can be sampled in a good state.

In addition, when sampling blood, it is possible to suppress a decrease in the amount collected.
Further, since the storage portion is provided in the second tube, when the storage portion is provided in a portion other than the second tube (for example, in the third tube branched from the second tube) Compared to a case where the blood is provided, the operation when sampling blood (when collecting blood for examination) is easier.

Hereinafter, the blood collection instrument of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
FIG. 1 is a plan view showing a first embodiment of a blood collection instrument according to the present invention.

  As shown in the figure, the blood collection device 1 has a blood collection bag 10 for storing the collected blood.

  The blood collection bag 10 is formed by stacking flexible sheet materials made of a soft resin such as polyvinyl chloride, which will be described later, and fused (thermal fusion, high frequency fusion, etc.) or adhesion at the peripheral seal portion 12. The bag body 11 has a bag shape.

  A blood storage portion 13 for storing the collected blood is formed in an inner portion surrounded by the seal portion 12 of the bag body 11. The blood collection bag 10 may also be used as a red blood cell bag for storing red blood cells. In this case, the blood storage unit 13 stores and stores concentrated red blood cells.

  Two openings 14 and 14 are formed in the upper portion of the bag body 11 so as to be openable by a peel tab, and a discharge port 18 is formed in a side portion of the one opening 14. One end of a tube 61 is connected to the discharge port 18 via a sealing member (connecting member) 17. As the sealing member 17, the thing of the structure similar to the sealing member 93 mentioned later can be used.

  Although not shown, one or more bags such as a plasma bag, a buffy coat bag, and a platelet bag (medical solution storage bag) may be provided on the other end side of the tube 61. That is, the blood collection instrument may constitute a bag connector.

  Further, in the present invention, the sealing member 17, the discharge port 18, and the tube 61 described above may be omitted.

  Further, one end of a flexible tube 15 is connected to the upper portion of the bag body 11 so as to communicate with the blood storage unit 13, and a blood collection needle 152 is attached to the other end of the tube 15 via a hub 151. Has been. The hub 151 is fitted with a cap 153 that encloses the blood collection needle 152. The main portion of the first flow path is constituted by the lumen of the tube 15.

  In the middle of the tube 15, a bifurcated connector (branch portion) 92 that branches into two branches is provided. One end of a flexible tube 91 is connected to the branch connector 92.

  Here, although the illustrated branch connector 92 is a toroidal tube, the branch connector 92 in the present invention is not limited to this, for example, the direction of a Y-shaped tube, a T-shaped tube, a toroidal tube, and a Y-shaped tube. May be reversed.

  Further, between the branch connector 92 of the tube 15 and the blood collection bag 10, a clamp (clamp member) 16 serving as a first flow path sealing means is provided. The clamp 16 is preferably arranged in the vicinity of the branch connector 92.

  The blood collection device 1 has a bag (bag body) 20 which is a storage unit for temporarily storing the collected blood.

  The bag 20 is made of, for example, a flexible sheet material made of a soft resin such as polyvinyl chloride, which will be described later, and is fused (thermally fused, high frequency fused, etc.) or adhered to the peripheral seal portion 22. The bag body 21 has a bag shape.

  A storage portion 23 is formed in an inner portion surrounded by the seal portion 22 of the bag body 21.

  The other end of the tube 91 is connected to one end portion (left end portion in FIG. 1) of the bag body 21 so as to communicate with the storage portion 23.

  The capacity of the bag 20 is not particularly limited and is determined in consideration of various conditions such as the space volume (volume) of the lumen of the tube forming the circuit, but is preferably about 10 to 100 ml, and about 20 to 50 ml. More preferred.

  If the capacity of the bag 20 is less than the above range, a predetermined amount of collected blood may not be stored when the volume of the lumen of the tube forming the circuit is relatively large. If it exceeds, the blood collection device 1 becomes large and difficult to operate.

  A sealing member (second channel sealing means) 93 is provided in the middle of the tube 91. The configuration of the sealing member 93 will be described in detail later.

  Further, between the sealing member 93 of the tube 91 and the bag 20, a clamp (clamp member) 95 which is a second flow path sealing means is provided. This clamp 95 is preferably arranged in the vicinity of the bag 20.

  One end of a flexible tube 96 is connected to the other end (the right end in FIG. 1) of the bag body 21 so as to communicate with the storage portion 23, and the other end (end) of the tube 96. Is connected to a sampling port (connector) 71. The configuration of the sampling port 71 will be described in detail later. The main part of the second flow path is constituted by the lumens of the tubes 96 and 91.

  In this blood sampling instrument 1, the tube 96 is connected to the side opposite to the tube 91 of the bag 20, but in the present invention, the connection portion of the tube 96 to the bag 20 and the connection portion of the tube 91 to the bag 20 are connected. For example, the tube 96 may be connected to the same side as the tube 91 of the bag 20 (left side in FIG. 1).

  In the present invention, the sampling port 71 may be directly connected to, for example, the left end or the right end in FIG.

  The area of the cross section of the flow path of the tubes 91 and 96 is preferably set smaller than that of the tube 15. That is, it is preferable to make the inner diameters of the tubes 91 and 96 smaller than the inner diameter of the tube 15. In this way, there is an advantage that the amount of blood remaining in the tubes 91 and 96 can be reduced in introducing the collected blood into the blood collection bag 10 described later.

  In addition, the length of the tube 96 is preferably set shorter than that of the tube 91, and particularly preferably set to such an extent that the air in the tube 96 is not substantially affected. That is, the bag 20 is preferably installed in the vicinity of the sampling port (blood outlet) 71.

  Moreover, it is preferable that an anticoagulant is placed in advance in the blood collection bag 10 described above. This anticoagulant is usually a liquid, and examples thereof include an ACD-A solution, a CPD solution, a CPDA-1 solution, and a heparin sodium solution. The amount of these anticoagulants is an appropriate amount according to the planned blood collection amount.

  Next, the sheet material constituting the blood collection bag 10 and the bag 20, the constituent materials of the tubes 15, 61, 91, and 96 will be described.

[1] About Blood Collection Bag 10 The composition, characteristics, etc. of the sheet material constituting the bag body 11 of the blood collection bag 10 are not particularly limited.

  In this case, the constituent material of the sheet material of the blood collection bag 10 is a material mainly composed of soft polyvinyl chloride or soft polyvinyl chloride (for example, a copolymer with a small amount of other polymer material, a polymer blend, a polymer alloy). Etc.) is preferred.

  As the plasticizer in the soft polyvinyl chloride, for example, di-2-ethylhexyl phthalate (DEHP), dinormaldecyl phthalate (DnDP) and the like are preferable.

The content of the plasticizer in the sheet material is preferably about 25 to 50 wt%, more preferably about 30 to 40 wt%.
The sheet material as described above can be manufactured, for example, by the following method.

  A predetermined material is sufficiently kneaded using a kneader, the kneaded product is extruded through a T die or a circular die, and the obtained flat sheet-like material is subjected to thermoforming, blowing, stretching, cutting, and cutting. Steps such as part sealing (fusion) are sequentially performed to form a desired shape and form.

  Moreover, in order to prevent blocking between sheets, the surface of a sheet (base material) can be roughened (embossed), or an anti-blocking agent, a slip agent, etc. can be added or added.

[2] About Bag 20 The composition, characteristics, etc. of the sheet material constituting the bag body 21 of the bag 20 are not particularly limited, and for example, the same material as the sheet material in the blood collection bag 10 can be used. When the same material as the sheet material in the blood collection bag 10 is used, the number of sheet materials to be prepared is reduced, which is advantageous in manufacturing.

[3] Tubes 15, 61, 91, and 96 The constituent materials of the tubes 15, 61, 91, and 96 are, for example, soft polyvinyl chloride, polyethylene, polypropylene, ethylene-vinyl acetate copolymer, styrene-butadiene-styrene. Examples thereof include thermoplastic elastomers such as copolymers, and materials mainly composed of these materials. Among them, soft polyvinyl chloride or materials mainly composed of these materials are preferable.

  If each tube is made of soft polyvinyl chloride, sufficient flexibility and softness can be obtained, so that it is easy to handle and suitable for clogging with a clamp or the like. In addition, the tube made of soft polyvinyl chloride is excellent in compatibility with the bag material of the same main material, so when joining them by fusion or adhesion, the joint strength is high and the air tightness is excellent. It is preferable for maintaining durability and sterility against the centrifugation operation. In addition, the kind of plasticizer used for each tube and its content are not specifically limited.

  Here, the dimensions such as the inner diameter and the outer diameter of the tubes 91 and 96 are not particularly limited. However, if the inner diameter is too large or the wall thickness is too thin (the ratio of the outer diameter / the inner diameter is small), the tubes 91 and 96 will be described. However, since it is soft and sealed by the sealing member 93 and a cap 76 to be described later, it is easily deformed into a flat shape when subjected to high-pressure steam sterilization.

  Further, when the inner diameters of the tubes 91 and 96 are relatively large, the spatial volume (volume) of the lumens of the tubes 91 and 96 is increased, and when blood collection and blood sampling are performed, Loss may occur.

  As a countermeasure to this tube volume problem, there is a method of using tubes 91 and 96 having relatively small inner and outer diameters, but the outer diameter is reduced in terms of connection (joining) with other members. In addition, there is a limit, and the deformation of the tubes 91 and 96 during the above-described high-pressure steam sterilization cannot be sufficiently prevented.

  Therefore, in order to effectively solve such a problem, the inner diameter of the tubes 91 and 96 is preferably about 0.5 to 2.0 mm, more preferably about 0.8 to 1.5 mm. The diameter is preferably about 2 to 4 times the inner diameter, and more preferably about 2.5 to 3.5 times the inner diameter.

  Moreover, when the inner diameters of the tubes 91 and 96 are less than the above range, blood may not flow smoothly in sampling of blood into the decompression blood collection tube 85 described later, and the blood flow rate may be insufficient. The blood flow rate is usually preferably about 1 to 5 μm / sec.

  In particular, the outer diameter of the tubes 91 and 96 is preferably about 4.0 to 4.5 mm as the most suitable size for connection with other members.

  Next, the configuration of the sealing members 17 and 93 will be described. In addition, since the structure of each sealing member 17 and 93 is substantially the same, the sealing member 93 is demonstrated typically.

  FIG. 2 is a vertical cross-sectional view showing a configuration example of the sealing member 93. As shown in the figure, the sealing member 93 includes a short tube 930 made of a flexible resin, such as soft polyvinyl chloride, and is liquid-tightly inserted into the short tube 930 and is solid. A cylindrical body 931 whose one end is closed by a columnar portion 932 is formed.

  One end of the upper tube 91 in FIG. 2 is liquid-tightly connected to the upper end portion of the short tube 930 in FIG. 2, and one end of the lower tube 91 in FIG. 2 is connected to the lower end portion of the short tube 930 in FIG. Are connected in a liquid-tight manner.

  A thin and fragile fracture portion 933 is formed on the outer periphery of the cylindrical body 931. The flow path is opened by bending the solid columnar portion 932 together with the short tube 930 from the outside of the short tube 930 with fingers or the like to break the fracture portion 933 and separating the solid columnar portion 932.

  Examples of the constituent material of the cylindrical body 931 include hard materials such as hard polyvinyl chloride, polycarbonate, and polyester.

  In addition, the upper portion of the solid columnar portion 932 in the figure has a wedge shape, and the upper end portion (top portion) 934 has a width dimension smaller than the outer diameter of the cylindrical body 931 and larger than the inner diameter of the tube 91. It is preferable that the solid columnar portion 932 does not block the tube 91 after the solid columnar portion 932 is broken and separated. Further, as illustrated, a groove 935 that promotes blood circulation may be provided in the upper end 934 of the solid columnar portion 932.

  Next, the configuration of the sampling port 71 will be described. FIG. 3 is a longitudinal sectional view showing a configuration example of the sampling port 71. In the following description, the right side in FIG. 3 is referred to as “tip”, and the left side is referred to as “base end”.

  As shown in the figure, the sampling port 71 includes a connector main body 73, a plug 77, and a cap 76.

The base end portion 732 of the connector main body 73 is liquid-tightly connected to the end portion of the tube 96.
The connector main body 73 has a substantially cylindrical shape, and ribs 74 are erected on the outer peripheral surface thereof.

  In addition, a plug (plug body) 77 that can be punctured by a needle tube is fitted into the distal end portion 731 of the connector main body 73. Examples of the needle tube include a puncture needle (double-ended needle) and an injection needle of a blood collection device for reduced-pressure blood collection tubes.

  A cap 76 that encloses the plug 77 is attached to the distal end side of the connector main body 73. A blood outlet is formed near the plug 77 on the distal end side of the connector main body 73.

  Examples of the constituent material of the connector main body 73 and the rib 74 include hard materials such as hard polyvinyl chloride, polycarbonate, and polyester.

  Further, as the constituent material of the stopper 77, it is preferable to use a material that can puncture the needle tube relatively easily. For example, natural rubber, isoprene rubber, butyl rubber, silicone rubber, urethane rubber, acrylic rubber, butadiene rubber, styrene- Examples include various rubber materials such as butadiene rubber.

  Examples of the constituent material of the cap 76 include various rubber materials such as natural rubber, isoprene rubber, butyl rubber, silicone rubber, urethane rubber, acrylic rubber, butadiene rubber, and styrene-butadiene rubber.

  As shown in FIG. 4, for example, a holder (depressurized blood collection device for reduced pressure collection tube) 82 of a reduced pressure blood collection tube (container) 85 is connected to the sampling port 71. The initial flow (initial blood collection flow) is collected in the vacuum blood collection tube 85.

  Here, the reduced-pressure blood collection tube 85 includes a blood collection tube main body 86 and a rubber plug 87 fitted into the blood collection blood tube main body 86. The inside of the decompression blood collection tube 85 is in a vacuum or a decompressed state.

  The holder 82 includes a bottomed cylindrical holder main body 83 and a double-ended needle 84 that is installed concentrically with the holder main body 83.

  In this case, a member (luer adapter 841) on which a male screw is formed is fixed to the double-ended needle 84, and a female screw that is screwed with the male screw is formed at the center of the bottom portion (left end portion in FIG. 4) of the holder body 83. Then, by screwing them together, the double-ended needle 84 is detachably mounted and fixed to the holder main body 83.

  Note that the length on the left side in FIG. 4 and the length on the right side in FIG. 4 of the double-ended needle 84 are set to lengths that can sufficiently pierce the stopper 77 and the rubber stopper 87, respectively.

  Although not shown in the drawing, a stretchable (elastic material) encapsulating member that encapsulates the double-ended needle 84 may be installed on at least one side of the luer adapter 841 as a boundary. Thereby, the leakage of blood from the double-ended needle 84 can be prevented.

  Next, based on FIG. 1 and FIG. 4, the operation of the blood collection device 1 (blood treatment method using the blood collection device) will be described.

  As shown in FIG. 4, the cap 76 is removed from the connector main body 73 of the sampling port 71, and the double-ended needle 84 of the holder 82 is pierced through the plug 77 of the sampling port 71, thereby penetrating the holder 82 into the sampling port 71. Installing.

  Then, the blood collection bag 10 and the bag 20 of the blood collection instrument 1 are respectively installed at positions lower than the part where the blood collection needle 152 is punctured.

  Next, as shown in FIG. 1, the tube 15 is pressure-closed by the clamp 16 and the flow path is closed (blocked). Further, the clamp 95 is opened, and the flow path of the tube 91 between the sealing member 93 and the bag 20 is opened (opened).

  Next, the cap 153 is removed from the hub 151, the blood collection needle 152 is punctured into the vein (blood vessel) of the donor (blood donor), and when it is confirmed that the blood collection needle 152 captures the vein, the hub 151 is fixed with tape or the like. Then, the breaking portion 933 of the sealing member 93 is broken to separate the solid columnar portion 932, and the flow path in the sealing member 93 is opened.

  As a result, the initial blood flow (blood) flows into the tube 91 via the blood collection needle 152, a part of the tube 15 (part from the blood collection needle 152 to the branch connector 92), the branch connector 92, and flows through the tube 91. Introduced into the storage part 23 of the bag 20. In this case, since the flow path of the tube 15 is blocked by the clamp 16, blood flows from the tube 15 through the branch connector 92 into the tube 91.

  In addition, before the blood is introduced, the air in the tubes 15 and 91 and the branch connector 92 is discharged from the other end of the tube 91 and collected in the bag 20.

  As a result, the pressure in the tubes 15 and 91 and the volume of the lumens of the tubes 15 and 91 are kept substantially constant, and an excessive load can be prevented from being applied to the blood cells. It is possible to prevent hemolysis and the like from occurring.

  Further, blood does not enter and remain on the side of the clamp 16 at the branch connector 92.

  In this manner, after a predetermined amount of blood is collected (collected) in the bag 20, the tube 91 is closed with the clamp 95, and the flow path is closed (blocked).

Next, blood collection into the blood collection bag 10 is started.
In this case, the clamp 16 is opened, and the flow path of the tube 15 is opened (opened). Thereby, the collected blood flows through the tube 15 and is introduced into the blood storage part 13 of the blood collection bag 10.

  In parallel with the blood collection into the blood collection bag 10, the blood stored in the bag 20 is collected (sampled) into the reduced pressure blood collection tube 85.

  In this case, the reduced-pressure blood collection tube 85 is inserted into the holder 82 and pushed into the innermost part of the holder 82, and the double-ended needle 84 of the holder 82 is punctured into the rubber stopper 87 and penetrated. Thereby, the blood stored in the bag 20 flows through the tube 96 and is sucked into the vacuum blood collection tube 85 and collected. After the blood sampling into the decompression blood collection tube 85 is completed, the decompression blood collection tube 85 is pulled out from the holder 82.

  When sampling blood into a plurality of decompression blood collection tubes 85, the above-described operation is repeated.

  After the blood collection into the decompression blood collection tube 85, that is, the sampling of the blood into the decompression blood collection tube 85 is completed, the holder 82 is removed from the sampling port 71, and the cap 76 is attached to the connector main body 73 of the sampling port 71.

  In addition, since the plug 77 is fitted in the connector main body 73 of the sampling port 71, the blood leakage can be prevented by the plug 77.

  Further, in collecting blood into the blood collection bag 10, after a predetermined amount of blood has been collected into the blood collection bag 10, the blood collection needle 152 is extracted from the blood vessel of the donor, a cap 153 is attached to the hub 151, and a tube sealer or the like is provided if necessary. Thus, the tubes 91 and 15 are sealed by fusion, the sealed portion is cut, and the tubes 91 and 15 on the sampling port 71 side are separated and removed.

  Thereby, the blood collection bag 10 in which the collected blood from which the initial blood collection flow has been removed is stored is obtained.

  In the case of the bag assembly described above, the collected blood stored in the blood collection bag 10 is subjected to a centrifugal separation operation, and separated into a plurality of blood components such as red blood cells, buffy coats, and plasma, and separated. The blood component is transferred to a predetermined blood component bag connected to the blood collection bag 10 according to a conventional method.

  On the other hand, the initial blood collection collected in the reduced-pressure blood collection tube 85 is discarded or used for, for example, biochemical examination of serum, antibody examination of infectious disease virus (for example, AIDS, hepatitis, etc.). it can.

  As described above, according to the blood collection instrument 1, the blood collection initial stream having a high probability of bacterial infection can be easily and reliably removed at the time of blood collection. Bacteria are prevented from being mixed in each blood component separated from the blood, improving safety.

  In the case where the bag 20 is not provided, when sampling the initial blood collection into the decompression blood collection tube 85, the initial blood collection may enter and remain on the side of the clamp 16 at the branch connector 92. When blood is collected into the blood collection bag 10 after sampling, there is a possibility that the initial blood collection remaining on the side of the clamp 16 may be mixed into the blood collection bag 10.

  The main cause of the entry of blood into the clamp 16 is as follows. When the bag 20 is not provided, when the initial blood collection flow is introduced into the tube 91 and sampled into the vacuum blood collection tube 85, there is no escape space for the air in the tubes 15 and 91, and the air is discharged to the outside. Therefore, the tubes 15 and 91 from the blood collection needle 152 to the sampling port 71 cannot be filled with blood, and the gas-liquid interface stops in the middle of the tube 15 or 91. When the decompression blood collection tube 85 is attached in this state, the air in the tubes 15 and 91 is sucked into the decompression blood collection tube 85 at the moment when the decompression blood collection tube 85 and the sampling port 71 communicate with each other. The road suddenly becomes depressurized. In order to restore the reduced pressure state in the circuit to the normal pressure state, blood is filled in the circuit. At that time, it is considered that blood also enters the clamp 16 side.

  However, since the blood collection instrument 1 has the bag 20 between the branch connector 92 and the sampling port 71 (second flow path), the air in the tubes 15 and 91 is removed from the bag as described above. Therefore, the blood does not enter and remain on the side of the clamp 16 at the branch connector 92. Therefore, the initial blood collection can be reliably removed.

  Moreover, when the bag 20 is not provided, hemolysis may occur in the blood sampled in the vacuum blood collection tube 85, and this hemolysis may reduce the measurement accuracy in the measurement of sodium and potassium in the serum. is there.

  The main causes of this hemolysis are as follows. As described above, when the bag 20 is not provided, when blood is introduced into the tube 91 and sampled into the vacuum blood collection tube 85, the blood in the tubes 15 and 91 from the blood collection needle 152 to the sampling port 71 is removed. Can not be satisfied with. When the decompression blood collection tube 85 is attached in this state, the air in the tubes 15 and 91 is sucked into the decompression blood collection tube 85 at the moment when the decompression blood collection tube 85 and the sampling port 71 communicate with each other. The road is suddenly depressurized. At this time, due to a combination of factors such as the position of the blood collection needle 152 and the softness of the blood vessels, the tubes 15 and 91 are crushed, the cross-sectional area of the flow path is reduced, and the suction pressure is relatively large (blood by suction). In combination with the relatively high movement speed of the sample), it is considered that the cells in the sampled blood, particularly the red blood cells, are damaged.

  However, since the blood collecting instrument 1 has the bag 20 between the branch connector 92 and the sampling port 71, it is possible to prevent hemolysis from occurring in the blood as described above.

  In addition, it is usual to perform blood sampling by replacing a plurality of reduced-pressure blood collection tubes 85 with the holder 82. However, when the bag 20 is not provided, the first reduced-pressure blood collection tube 85 uses the reduced-pressure blood collection tubes 85. The amount of blood actually sampled (sample amount) is reduced with respect to the sampleable amount of 85 (maximum amount that can be sampled by suction by decompression). Insufficient sample volume adversely affects the number of inspection items, inspection accuracy, inspection workability, and the like.

  As described above, when the bag 20 is not provided, the main cause of this is that when the blood is introduced into the tube 91 and sampled into the vacuum blood collection tube 85, the air escape space in the tubes 15 and 91 is lost. Since the air cannot be discharged to the outside, the tubes 15 and 91 from the blood collection needle 152 to the sampling port 71 cannot be filled with blood. In this state, when the reduced pressure blood collection tube 85 is attached, This is because the air in the tubes 15 and 91 is sucked into the vacuum blood collection tube 85 and collected.

  However, as described above, the blood collection instrument 1 has the bag 20 that temporarily stores blood in the vicinity of the sampling port 71 of the second flow path, and is stored in the bag 20. Since the blood is sampled into the decompression blood collection tube 85, even if the air in the tube 96 is sucked into the first decompression blood collection tube 85, the amount thereof is small. The amount of blood (sample amount) can be brought close to the sampleable amount of the decompression blood collection tube 85.

  Further, when the bag 20 is provided in a portion other than the second flow path, for example, when the bag 20 is provided in a third flow path branched from the second flow path, the initial blood collection flow is introduced into the tube 91. When sampling into the reduced pressure blood collection tube 85, an operation for switching the flow path (flow path switching operation) is required. However, in this blood collection instrument 1, as described above, the bag 20 is used as the second flow path. Since it is installed, the flow path switching operation is unnecessary, and therefore, the operation in blood processing using the blood collection instrument 1 described above is easy.

  Moreover, in the blood collection instrument 1, since the sealing member 93 is provided on the tube 91, it is possible to freely select the time when the initial blood collection flow begins to flow into the tube 91.

  Further, as described above, the inner diameters of the tubes 91 and 96 are made relatively small (particularly about 0.5 to 2.0 mm), and the thickness of the tubes 91 and 96 is made relatively large (especially, the outer diameter is reduced to the inner diameter). When it is about 2 to 4 times, the deformation (collapse) of the tubes 91 and 96 during high-pressure steam sterilization can be suppressed.

Next, a second embodiment of the blood collection instrument of the present invention will be described.
FIG. 5 is a plan view showing a second embodiment of the blood collection device of the present invention. In addition, description is abbreviate | omitted about the common point with the instrument 1 for blood collection mentioned above, and a main difference is demonstrated.

  As shown in the figure, the blood sampling device 1a has a check valve (back flow preventing means) 94 between the other end of the tube 96, that is, the right end of the tube 96 in FIG. is doing.

  6 is a longitudinal sectional view showing a configuration example of the check valve 94, and FIG. 7 is a sectional view taken along line AA in FIG. In the following description, the right side in FIGS. 6 and 7 is referred to as “base end”, and the left side is referred to as “tip”.

  As shown in these drawings, the check valve 94 includes a short tube 940 made of a flexible resin such as soft polyvinyl chloride, and a valve body 941 made of an elastic material. ing. The valve body 941 is fitted and fixed in a liquid-tight manner in the short tube 940.

  The sampling port 71 is liquid-tightly connected to the distal end of the short tube 940, and the end of the tube 96 is liquid-tightly connected to the proximal end of the short tube 940.

  The valve main body 941 communicates with the tube 96 and has a hollow portion 942 that becomes a part of the blood flow path. A tapered surface 943 is formed at the tip of the hollow portion 942. That is, the length L in the vertical direction in FIG. 6 of the distal end portion of the hollow portion 942 gradually decreases from the proximal end side toward the distal end side.

  A pair of plate-like opening / closing members 944 and 944 are formed at the tip of the valve body 941. The open / close members 944 and 944 are in close contact with each other by an elastic force and a restoring force, whereby the flow path in the check valve 94 is closed. When the blood flow is directed from the distal end side to the proximal end side, pressure is applied to the outer surface of each opening / closing member 944, 944 by the blood, and acts to bring the opening / closing member 944 into close contact with each other. For this reason, blood does not flow from the distal end side to the proximal end side.

  On the other hand, when the blood flow is directed from the proximal end side to the distal end side, a predetermined pressure is applied to the distal end portion of the tapered surface 943 by the blood, and the opening and closing members 944 and 944 are displaced in a direction away from each other by the pressure. Then, the flow path in the check valve 94 is opened. Thereby, blood flows from the proximal end side to the distal end side.

  Examples of the constituent material of the valve body 941 include various rubber materials such as natural rubber, isoprene rubber, butyl rubber, silicone rubber, urethane rubber, acrylic rubber, butadiene rubber, and styrene-butadiene rubber.

  The check valve 94 prevents blood from flowing backward. That is, blood does not flow from the sampling port 71 to the branch connector 92 side (bag 20 side), but flows only from the branch connector 92 (bag 20) to the sampling port 71 side.

  Therefore, when the blood stored in the bag 20 is sampled into the decompression blood collection tube 85, the check valve 94 can prevent the blood from flowing back to the bag 20 side.

In the present invention, the position of the check valve 94 is not particularly limited as long as it is the second flow path, but the position of the check valve 94 is preferably on the sampling port 71 side than the bag 20 as described above. More preferably between the sampling port 71.
This blood collection device 1a can also achieve the same effects as the blood collection device 1 described above.

Next, a third embodiment of the blood collection instrument of the present invention will be described.
FIG. 8 is a plan view showing a third embodiment of the blood collection instrument of the present invention. In addition, description is abbreviate | omitted about a common point with the instrument 1a for blood collection mentioned above, and a main difference is demonstrated.

  As shown in the figure, the blood collection device 1b has a check valve (backflow prevention means) 94 in the middle of the tube 91, that is, between the sealing member 93 and the clamp 95 of the tube 91.

When blood is introduced into the bag 20, the check valve 94 can prevent the backflow of blood to the branch connector 92 side.
This blood collection device 1b can also obtain the same effects as the blood collection device 1a described above.

Next, a fourth embodiment of the blood collection instrument of the present invention will be described.
FIG. 9 is a plan view showing a fourth embodiment of the blood collection device of the present invention. In addition, description is abbreviate | omitted about a common point with the instrument 1a for blood collection mentioned above, and a main difference is demonstrated.

  As shown in the figure, in the blood sampling instrument 1c, the first flow path sealing means is constituted by a breakable sealing member 19 that opens when the first flow path is broken. That is, the blood collection instrument 1 c has a sealing member (first flow path sealing means) 19 between the branch connector 92 of the tube 15 and the blood collection bag 10. The sealing member 19 is preferably disposed in the vicinity of the branch connector 92.

  As this sealing member 19, the thing of the structure similar to the sealing member 93 mentioned above can be used.

Similarly to the blood collection device 1a described above, the blood collection device 1c is provided with a check valve (reverse flow prevention) between the other end of the tube 96, that is, between the right end of the tube 96 in FIG. Means) 94, and when the blood stored in the bag 20 is sampled into the vacuum blood collection tube 85, the check valve 94 can prevent the blood from flowing back to the bag 20 side.
This blood collection device 1c can also provide the same effects as the blood collection device 1a described above.

Next, specific examples of the blood collection instrument of the present invention will be described.
Example 1
A blood collecting instrument 1 shown in FIG. 1 was prepared. The capacity of the bag 20 was 20 ml. Using this blood collection device, the initial blood collection is temporarily stored in the bag 20 by the above-described method, and then 200 ml of blood is collected in the blood collection bag 10 and the initial blood collection stored in the bag 20 is collected. Was collected (sampled) in a vacuum blood collection tube 85. A vacuum blood collection tube with a sampling capacity of 10 ml was used.

(Example 2)
A blood collecting device 1a shown in FIG. 5 (the capacity of the bag 20 is 20 ml) is prepared, and 200 ml of blood is collected in the blood collecting bag 10 in the same manner as in Example 1 and the initial flow of blood is reduced. It was collected (sampled) in a blood collection tube 85. A vacuum blood collection tube with a sampling capacity of 10 ml was used.

(Example 3)
A blood collecting device 1b shown in FIG. 8 (the capacity of the bag 20 is 20 ml) is prepared. Similarly to Example 1, 200 ml of blood is collected in the blood collecting bag 10 by the method described above, and the initial blood collection is decompressed. It was collected (sampled) in a blood collection tube 85. A vacuum blood collection tube with a sampling capacity of 10 ml was used.

Example 4
A blood collection device 1c shown in FIG. 9 (the capacity of the bag 20 is 20 ml) is prepared, and 200 ml of blood is collected in the blood collection bag 10 by the method described above, and the initial blood collection flow is reduced in the same manner as in Example 1. It was collected (sampled) in the blood collection tube 85. A vacuum blood collection tube with a sampling capacity of 10 ml was used.

(Comparative Example 1)
A blood collection device having a structure substantially the same as that of Example 1 was prepared except that the bag 20 and the clamp 95 were omitted. Using this blood collection instrument, the initial blood collection was directly collected (sampled) into the vacuum blood collection tube 85, and then 200 ml of blood was collected in the blood collection bag 10. A vacuum blood collection tube with a sampling capacity of 10 ml was used.

(Comparative Example 2)
A blood collecting instrument having substantially the same structure as that of Example 1 was prepared except that the branch connector 92, the tube 91, the sealing member 93, the clamp 95, and the bag 20 were omitted. Using this blood collection device, 200 ml of blood was collected in a blood collection bag 10 by a conventional method.

  In any of Examples 1 to 4 and Comparative Examples 1 and 2, the donor solution of Yersinia enterocolitica (phosphate buffer suspension) was applied to the donor site once a day from one week before blood collection. Liquid: concentration 100 cfu / ml) was applied with a cotton swab. In addition, the planned puncture site was not washed until blood collection.

  Next, using the collected blood stored in the blood collection bag in Examples 1 to 4 and Comparative Examples 1 and 2, the following bacterial culture test was performed.

[Bacteria culture test]
After mixing 200 ml of blood in the blood collection bag, an operation adapter is inserted into the opening 14 of the blood collection bag 10, and about 50 ml of blood is aseptically sampled from the rubber part of the operation adapter using a syringe and a needle attached thereto. The blood was poured into a glass container in which a culture medium was stored, and was subjected to culture.

  For the number of examinations (number of donors) 25, the number of bacteria detected (number of bacteria detected) after culturing was examined. The medium and various culture conditions are as follows.

Medium: Brain Heart Infusion w / PAB and CO2, Under Vacuum (Difco)
Medium volume: 50ml
Culture temperature: 25-30 ° C
Observation period (culture period): 10 days The results of this bacterial culture test are shown in Table 1 below.

<Consideration of results>
In Examples 1 to 4, when the initial blood collection flow is introduced into the bag 20, the air in the tube can be released into the bag 20, whereby the pressure in the tube and the volume of the lumen of the tube are substantially constant. Therefore, the blood does not enter and remain on the side of the clamp 16 at the branch connector 92, and therefore, the initial blood collection is almost completely removed from the collected blood. Therefore, as shown in Table 1 above, the number of bacteria detected was 0.

  On the other hand, in the comparative example 2, since the collected blood contained the initial blood collection, the number of bacteria detected was large.

  Further, in Comparative Example 1, when sampling the initial blood flow into the reduced pressure blood collection tube, the air in the tube cannot be discharged to the outside, so that the tube from the blood collection needle to the sampling port cannot be filled with blood. For this reason, immediately after mounting the reduced-pressure blood collection tube, blood is filled in the circuit in order to restore the reduced pressure state to the normal pressure state. At that time, blood may enter and remain on the clamp 16 side, and the blood is mixed in the collected blood, and the number of bacteria detected cannot be reduced to zero.

  In Examples 1 to 4 and Comparative Example 1, the degree of hemolysis (the number of hemolysis detected) of the blood sample sampled in the vacuum blood collection tube 85 and the average value of the sample amount are shown in Table 2 below.

  The blood sample was examined for the degree of hemolysis as follows. After blood coagulation, the serum was separated by centrifugation at 3000 rpm for 10 minutes, and the color of the serum was visually observed. Then, according to the color tone of red, the following three ranks were judged: no hemolysis (level 0), slight hemolysis (level 1), and hemolysis (level 2).

No hemolysis (level 0): no red color tone is observed.
Slight hemolysis (level 1): Slight red color is observed.
Hemolysis (level 2): A red color tone is observed.

  The above-mentioned microhemolysis (level 1) and hemolysis (level 2) were regarded as “with hemolysis”, and the number of detections with hemolysis (the number of hemolysis detections) was determined.

<Consideration of results>
In Examples 1 to 4, when the initial blood collection flow is introduced into the bag 20, the air in the tube can be released into the bag 20, whereby the pressure in the tube and the volume of the lumen of the tube are substantially constant. Therefore, hemolysis does not occur as shown in Table 2 above. In other words, in Examples 1 to 4, there were 0 cases of slight hemolysis (level 1) and hemolysis (level 2).

  In Examples 1 to 4, since the initial blood collection was once stored in the bag 20 provided in the vicinity of the sampling port, and the blood was sampled into the vacuum blood collection tube, as shown in Table 2 above, the sample The amount hardly decreases.

  In contrast, in Comparative Example 1, hemolysis was observed. That is, there were 10 cases of microhemolysis (level 1). In Comparative Example 1, since the inside of the tube from the blood collection needle to the sampling port cannot be filled with blood, the air in the tube is sucked into the decompression blood collection tube at the moment when the decompression blood collection tube is attached. It is presumed that red blood cells and the like were damaged when the tube was crushed and blood flowed through the tube.

  Moreover, in Comparative Example 1, the inside of the tube from the blood collection needle to the sampling port cannot be filled with blood, and in this state, the blood is sampled by attaching the reduced pressure blood collection tube. As a result, the sample volume was reduced by 2 ml. Note that the decrease in the sample amount in Comparative Example 1 corresponds to the spatial volume of the tube length of 30 cm.

  As mentioned above, although the blood sampling instrument of the present invention has been described based on the illustrated embodiments, the present invention is not limited to these, and the configuration of each part is an arbitrary configuration having the same function. Can be replaced.

  For example, in the present invention, the predetermined configurations (configuration requirements) of the respective embodiments may be appropriately combined.

  Moreover, in this invention, a branch part is not restricted to a branch connector as shown in figure, For example, you may be comprised with the multiway cock, such as a three-way cock.

It is a top view which shows 1st Embodiment of the instrument for blood collection of this invention. It is a longitudinal cross-sectional view which shows the structural example of the sealing member in this invention. It is a longitudinal cross-sectional view which shows the structural example of the sampling port in this invention. It is a longitudinal cross-sectional view which shows the front-end | tip part of the sampling port shown in FIG. 3, a vacuum blood collection tube, and its holder. It is a top view which shows 2nd Embodiment of the instrument for blood collection of this invention. It is a longitudinal cross-sectional view which shows the structural example of the non-return valve in this invention. It is sectional drawing in the AA line in FIG. It is a top view which shows 3rd Embodiment of the instrument for blood collection of this invention. It is a top view which shows 4th Embodiment of the instrument for blood collection of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1, 1a, 1b, 1c Blood collection instrument 10 Blood collection bag 11 Bag main body 12 Seal part 13 Blood storage part 14 Opening part 15 Tube 151 Hub 152 Blood collection needle 153 Cap 16 Clemme 17 Sealing member 18 Outlet 19 Sealing member 20 Bag 21 Bag Main Body 22 Sealing Portion 23 Storage Portion 61 Tube 71 Sampling Port 73 Connector Main Body 731 Tip Portion 732 Base End Portion 74 Rib 76 Cap 77 Plug 82 Holder 83 Holder Main Body 84 Double-head Needle 841 Luer Adapter 85 Depressurized Blood Collection Tube 86 Blood Collection Tube Main Body 87 Rubber stopper 91 Tube 92 Branch connector 93 Sealing member 930 Short tube 931 Cylindrical body 932 Solid columnar portion 933 Breaking portion 934 Upper end portion 935 Groove 94 Check valve 940 Short tube 941 Valve body 942 Hollow portion 943 Te Tapered surface 944 closing member 95 clamp 96 tube

Claims (10)

A blood collection needle to collect blood from a donor;
A blood collection bag for storing blood collected from the blood collection needle;
A first tube having one end communicating with the blood collection bag and the other end communicating with the blood collection needle, and introducing blood collected from the blood collection needle into the blood collection bag;
Branching from the first tube via the branching section, and having a storage section for temporarily storing blood, and a second tube having a blood outlet port stored in the storage section,
Before collecting the blood collected from the blood collection needle into the blood collection bag, the initial flow of the blood is introduced into the second tube and introduced into the storage unit, and then stored in the storage unit. A blood collection device for collecting the collected blood through the outlet,
The second tube is branched from the branch portion so that an angle formed by the first tube and the second tube between the blood collection needle and the branch portion is an acute angle. A blood sampling device characterized by   The blood collection instrument according to claim 1, wherein the storage portion is a bag body made of a resin sheet material having flexibility.   The blood collecting device according to claim 1 or 2, wherein the capacity of the storage portion is 10 to 100 ml.   The blood collection instrument according to any one of claims 1 to 3, wherein the storage portion is provided in the vicinity of the outlet.   5. The first flow path sealing means according to claim 1, wherein the flow path in the first tube between the branch portion and the blood collection bag can be opened from a blocked state. Blood collection instrument.   6. The blood collection device according to claim 5, wherein the first flow path sealing means is a breakable sealing member that opens the flow path in the first tube when broken.   7. The second flow path sealing means according to claim 1, further comprising: a second flow path sealing unit capable of blocking a flow path in the second tube between the branch portion and the storage portion from an open state. Blood collection instrument.   The blood collection device according to any one of claims 1 to 7, wherein the second tube has a backflow prevention means that allows a flow from the branch portion to the storage portion and prevents a flow in the reverse direction. .   2. The second tube includes a tube having one end connected to the branch portion and the other end connected to one end side of the storage portion, and the extraction port is provided on the other end side of the storage portion. The blood collecting instrument according to any one of 8 to 8.   The blood sampling instrument according to any one of claims 1 to 9, wherein the outlet is provided at an end of the second tube.

Images