JP3813974B2 - Blood collection instrument - Google Patents

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 can prevent bacterial contamination of collected blood, improve safety, and can collect blood for examination in a good state.

Such an object is achieved by the present inventions (1) to (8) below.
(1) a blood collection needle for collecting blood from a donor;
A blood collection bag containing an anticoagulant in advance and storing the 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 into the blood collection bag;
Branching from the first tube via a first branching section, and having a second tube having a blood outlet.
Prior to guiding the collected blood to the blood collection bag, the blood collection device removes the initial blood collection from the collected blood by guiding the blood to the second tube,
The blood collection instrument is provided between the first branch portion and the blood collection bag and in the vicinity of the first branch portion, blocks the flow path in the first tube, and breaks. Then, a breakable first sealing means for opening the flow path in the first tube;
A blood collection device comprising a bag provided on the second tube and collecting air.

  (2) The blood collection device includes a third tube branched from the second tube via a second branch portion, and the bag for collecting the air is attached to an end portion of the third tube. The blood collection device according to (1), which is provided.

  (3) The blood collection device according to (2), further including a third sealing unit that can block the flow path in the third tube.

  (4) The blood collection device according to any one of (1) to (3), wherein the bag for collecting the air has a capacity of 1 to 100 ml.

  (5) The blood collection device according to any one of (1) to (4), further including a second sealing unit capable of blocking the flow path in the second tube.

  (6) The above-described (1) to (1), further comprising a backflow prevention means provided on the second tube, which allows a flow from the first branch portion to the takeout port and prevents a flow in the reverse direction. 5) The blood collection device according to any one of 5).

  (7) Any of the above (1) to (6), wherein an area of a cross section of the flow path in the second tube is set smaller than an area of a cross section of the flow path in the first tube The blood collecting device described in 1.

  (8) The blood collection device according to any one of (1) to (7), wherein the blood outlet is configured by a connector.

  According to the present invention, the action of the bag that collects air (between the blood collection needle and the branch of the first tube and the air in the second tube is collected in the bag, etc.) In the branch portion of the second tube, the initial blood collection flow does not remain on the blood collection bag side, and the initial blood collection flow 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 testing), the action of a bag that collects air prevents the blood from being overloaded (for example, into blood cells typified by hemolysis). In this way, blood can be sampled in a good state.

  Moreover, when sampling blood, the reduction | decrease of a collection amount can be suppressed by the effect | action of the bag which collect | recovers air.

  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.

  Furthermore, one end of a flexible tube (first tube) 15 is connected to the upper portion of the bag body 11 so as to communicate with the blood storage portion 13, and the other end of the tube 15 is connected via a hub 151. A blood collection needle 152 is attached. The hub 151 is fitted with a cap 153 that encloses the blood collection needle 152. The main part of the first flow path is configured by the lumen of the tube 15 (the flow path in the tube 15).

  In the middle of the tube 15, a bifurcated branch connector (first branch portion) 92 is provided, and one end of a flexible tube (second tube) 91 is connected to the branch connector 92. ing. The main part of the second flow path is constituted by the lumen of the tube 91 (the flow path in the tube 91).

  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.

  The tube 15 between the branch connector 92 and the blood collection bag 10 is provided with a clamp (first sealing means) 16. The clamp 16 is preferably disposed in the vicinity of the branch connector 92.

  The other end (end portion) of the tube 91 is provided with a bifurcated branch connector (second branch portion) 32, and a sampling port (connector) 71 is connected to the branch connector 32. The configuration of the sampling port 71 will be described in detail later.

  Here, although the illustrated branch connector 32 is a toroidal tube, the branch connector 32 in the present invention is not limited to this, for example, the orientation of a Y-shaped tube, a T-shaped tube, a toroidal tube, and a Y-shaped tube. May be reversed.

  Further, in this blood sampling instrument 1, the sampling port 71 is connected to the other end (end portion) of the tube 91 via the branch connector 32. However, in the present invention, the branch connector 32 is in the middle of the tube 91. The sampling port 71 may be directly connected to the other end (end portion) of the tube 91.

  A sealing member (second sealing means) 93 is provided in the middle of the tube 91. In this case, the sealing member 93 is preferably disposed in the vicinity of the branch connector 92. The configuration of the sealing member 93 will be described in detail later.

  Here, in this invention, the 2nd sealing means is not limited to the sealing member 93, For example, using tube pressure closing means (sealing means which can open and close a flow path), such as a clamp, the tube 91 is used. May be closed with the clamp (tube pressure closing means) so that the flow path of the tube 91 can be blocked. In addition, a clamp (tube pressure closing means) may be provided together with the sealing member 93. In this case, the clamp (tube pressure closing means) is installed between the branch connector 92 and the sealing member 93. preferable.

  The blood sampling instrument 1 has a bag (bag) 20 for collecting air and suppressing pressure fluctuations.

  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.

  One end (terminal) of a flexible tube (third tube) 31 is connected to the upper portion of the bag body 21 so as to communicate with the storage portion 23, and the other end of the tube 31 is connected to the branch connector 32. Has been. The main part of the third flow path is configured by the lumen of the tube 31 (the flow path in the tube 31).

  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 1 to 100 ml, and about 5 to 30 ml. More preferred.

  If the capacity of the bag 20 is less than the above range, the effect of the bag 20 to be described later may not be obtained when the space volume of the lumen of the tube forming the circuit is relatively large. As a result, the blood collection device 1 is increased in size.

  The tube 31 is provided with a clamp (third sealing means) 33. This clamp 33 is preferably arranged in the vicinity of the branch connector 32. By disposing the clamp 33 in the vicinity of the branch connector 32, it is possible to suppress a decrease in the amount of blood that can be sampled into the first decompression blood collection tube 85 described later.

  The branch connector 32, the tube 31, the clamp 33 and the bag 20 constitute a pressure buffering means that suppresses pressure fluctuations in the flow path (second flow path) in the tube 91.

  The area of the cross section of the flow path in the tube 91 described above is preferably set smaller than that of the tube 15. That is, it is preferable to make the inner diameter of the tube 91 smaller than the inner diameter of the tube 15. In this way, there is an advantage that the amount of blood remaining in the tube 91 can be reduced in introducing the collected blood into the blood collection bag 10 described later. Hereinafter, the flow path in the tube is also simply referred to as “tube flow path”.

  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, 31, 61, and 91 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 applied.

[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, 31, 61, 91 As constituent materials of the tubes 15, 31, 61, 91, 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 tube 91 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 tube 91 is soft. Yes, since it is sealed by the sealing member 93 and a cap 76 described later, it becomes easy to be deformed into a flat shape when subjected to high-pressure steam sterilization.

  In addition, when the inner diameter of the tube 91 is relatively large, the spatial volume (volume) of the lumen of the tube 91 is increased, and blood loss is caused due to the spatial volume when blood collection and blood sampling are performed. There is.

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

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

  When the inner diameter of the tube 91 exceeds the above range, the amount of air discharged from the tube 91 increases in sampling of blood into the decompression blood collection tube 85 described later, so the tube 91 is shortened or the capacity of the bag 20 is increased. Must be bigger.

  Moreover, when the inner diameter of the tube 91 is 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 tube 91 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.

A base end 732 of the connector main body 73 is liquid-tightly connected to the branch connector 32.
The connector main body 73 has a substantially cylindrical shape, and ribs 74 are erected on the outer peripheral surface thereof.

  Further, a plug 77 is fitted into the distal end portion 731 of the connector main body 73. 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 a needle 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 82 of a decompression blood collection tube (container) 85 is connected to the sampling port 71, and the initial flow of blood (initial blood collection) is achieved by the holder 82 and the decompression blood collection tube 85. 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 1) will be described.

  First, an outline will be described. In the blood processing method using the blood collection instrument 1 (the action of the blood collection instrument 1), the blood collected from the blood collection needle 152 is guided to the tube 91. At this time, the air between the blood collection needle 152 of the first tube 15 and the branch connector 92 and in the tube 91 is collected in the bag 20. Thereafter, the initial blood collection flow is collected in the vacuum blood collection tube 85 via the sampling port 71 (the blood collection initial flow is removed from the collected blood), and the collected blood is introduced into the blood collection bag 10. That is, in the blood processing method using the blood collection instrument, the blood is guided to the tube 91 prior to introducing the blood collected from the blood collection needle 152 into the blood collection bag 10. Details will be described below.

  First, 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 33 is opened, and the flow path of the tube 31 is opened (opened).

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

  As a result, the initial blood collection (blood) flows into the tube 91 via the blood collection needle 152, part of the tube 15, and the branch connector 92, and flows toward the sampling port 71. 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. This blood introduction is performed by using the venous pressure and arranging the sampling port 71 at a position lower than the site where the blood collection needle 152 is punctured.

  When blood is introduced, the air in the tubes 15 and 91 and the branch connector 92 flows into the tube 31 through the branch connector 32, is discharged from the end of the tube 31, and is collected in the bag 20. . In other words, the decrease in the volume of the lumens of the tubes 15 and 91 due to the introduction of blood, that is, the increase in the pressure in the lumens of the tubes 15 and 91 is alleviated (suppressed) by the bag 20 being inflated.

  As described above, the pressure in the tubes 15 and 91 is kept almost constant, and it is possible to prevent an excessive load from being applied to the blood cells, thereby preventing hemolysis and the like from occurring in the blood. it can.

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

  When the blood reaches the vicinity of the branch connector 32, the tube 31 is closed with a clamp 33, the flow path is closed (blocked), and the introduction of blood is stopped.

  Next, 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. Attach to 71.

  Next, 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 and penetrated through the rubber stopper 87, thereby sampling blood. The blood is sucked into the vacuum blood collection tube 85 and collected.

  In this case, since the inside of the tubes 15 and 91 from the blood collection needle 152 to the sampling port 71 is almost filled with blood, the double-ended needle 84 of the holder 82 is punctured and penetrated into the rubber stopper 87 of the decompression blood collection tube 85. When blood is aspirated, an excessive load is not applied to the blood cells, so that it is possible to prevent hemolysis and the like from occurring in the blood, and the blood enters the clamp 16 side at the branch connector 92. It wo n’t be left behind.

  When the sampling of blood into the first decompression blood collection tube 85 is completed, the decompression blood collection tube 85 is pulled out from the holder 82, the next decompression blood collection tube 85 is inserted into the holder 82, and pushed into the innermost part of the holder 82. The double-ended needle 84 of the holder 82 is punctured and penetrated into the rubber stopper 87, and blood sampling is performed. The blood is sucked into the vacuum blood collection tube 85 and collected. This operation is repeated to sample blood into the required number of decompression blood collection tubes 85.

  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.

  Next, blood collection into the blood collection bag 10 is started. This blood collection is performed using, for example, a decompression type blood collection device or the like, or is performed by placing the blood collection bag 10 at a position lower than the site where the blood collection needle 152 is punctured.

  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 this way, after collecting a predetermined amount of blood, the blood collection needle 152 is removed from the blood vessel of the donor, a cap 153 is attached to the hub 151, and if necessary, the tubes 91 and 15 are fused by a tube sealer or the like. Sealing is performed, the sealing 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 device 1 (the blood processing method using the blood collection device 1), it is possible to easily and reliably remove the initial blood collection with a high probability of bacterial infection. Thus, contamination of bacteria into the collected blood and each blood component separated from the collected blood is prevented, and safety is improved.

  When the branch connector 32, the tube 31, the clamp 33 and the bag 20 are not provided, when sampling the initial blood collection flow into the decompression blood collection tube 85, the initial blood collection flow is directed to the clamp 16 at the branch connector 92. In some cases, the blood collected in the blood collection bag 10 may be left after the sampling, and the blood collection initial flow remaining on 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 or the like is not provided, when the initial blood collection flow is introduced into the tube 91 and sampled into the vacuum blood collection tube 85, the air in the tubes 15 and 91 has no escape and 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 branch connector 32, the tube 31, the clamp 33, and the bag 20, as described above, blood enters the clamp 16 side and remains in the branch connector 92. Therefore, the initial blood collection can be surely removed.

  Further, when the branch connector 32, the tube 31, the clamp 33 and the bag 20 are not provided, hemolysis may occur in the blood sampled in the vacuum blood collection tube 85, and this hemolysis causes sodium and potassium in the serum. There is a risk that the measurement accuracy in this measurement will be reduced.

  The main causes of this hemolysis are as follows. As described above, when the bag 20 or the like is not provided, when the blood is introduced into the tube 91 and sampled into the reduced-pressure blood collection tube 85, the inside of the tubes 15 and 91 from the blood collection needle 152 to the sampling port 71 is set. Can't fill with blood. 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 includes the branch connector 32, the tube 31, the clamp 33, and the bag 20, it is possible to prevent hemolysis from occurring in the blood as described above.

  In addition, it is usual to perform sampling of blood by replacing a plurality of reduced-pressure blood collection tubes 85 with the holder 82. However, if the branch connector 32, the tube 31, the clamp 33 and the bag 20 are not provided, the first one is used. In the decompression blood collection tube 85, the actually sampled amount of blood (sample amount) is smaller than the sampling possible amount of the decompression blood collection tube 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 or the like is not provided, the main cause is that when the blood is introduced into the tube 91 and sampled into the vacuum blood collection tube 85, the air in the tubes 15 and 91 is externally introduced. Therefore, the tubes 15 and 91 from the blood collection needle 152 to the sampling port 71 cannot be filled with blood. In this state, if the decompression blood collection tube 85 is attached, the tubes 15 and 91 This is because air is sucked into the vacuum blood collection tube 85 and collected.

  However, since the blood collection instrument 1 has the branch connector 32, the tube 31, the clamp 33, and the bag 20, as described above, the inside of the tubes 15 and 91 from the blood collection needle 152 to the sampling port 71 is almost blood. The blood can be sampled into the first vacuum blood collection tube 85 in a state where the vacuum is satisfied, and when the vacuum blood collection tube 85 is mounted, the tube 31 is closed with the clamp 33 and the flow path is blocked. Therefore, the air in the bag 20 and the air in the tube 31 on the bag 20 side from the clamp 33 can be prevented from being collected in the decompression blood collection tube 85. For this reason, sampling into the first decompression blood collection tube 85 is performed. The amount of blood that can be obtained (sample amount) can be matched with the sampleable amount of the decompression blood collection tube 85 as much as possible.

  Further, in the blood collection instrument 1, since the tube 91 is provided with the sealing member 93, it is possible to freely select the time when the initial blood collection flow begins to flow into the tube 91. For this reason, the connection to the sampling port 71, Depending on the instrument to be mounted or inserted, the initial blood collection stream can be flowed through the tube 91 at an appropriate timing.

  Further, as described above, the inner diameter of the tube 91 is made relatively small (especially about 0.5 to 2.0 mm) and the thickness of the tube 91 is made relatively large (especially the outer diameter is 2 to 4 times the inner diameter). The degree of deformation of the tube 91 during high-pressure steam sterilization can be suppressed.

Next, a second embodiment will be described.
FIG. 5 is a plan view showing a second embodiment of the blood collection device of the present invention.

  Hereinafter, the second embodiment will be described with a focus on the differences from the first embodiment described above, and the description of the same matters will be omitted.

  As shown in FIG. 5, in the blood collection instrument 1c of the second embodiment, when the tube 15 between the branch connector 92 and the blood collection bag 10 is broken as a first sealing means, the flow path of the tube 15 (first 1 is provided with a breakable sealing member 95 that opens. That is, the blood collection instrument 1c is obtained by changing the clamp 16 of the blood collection instrument 1 of the first embodiment described above to the sealing member 95, and other configurations are the same as those of the blood collection instrument 1 described above. .

  The sealing member 95 is preferably disposed in the vicinity of the branch connector 92. As the sealing member 95, the thing similar to the sealing member 93 mentioned above can be used, for example.

  Regarding the action of the blood sampling instrument 1c (the blood processing method using the blood sampling instrument 1c), an operation of breaking the fracture portion of the sealing member 95 is performed instead of the operation of opening the clamp 16 in the blood sampling instrument 1 described above. . That is, when blood collection into the blood collection bag 10 is started, the broken portion of the sealing member 95 is broken to separate the solid columnar portion, and the flow path in the sealing member 95 is opened. As a result, the flow path of the tube 15 is opened (opened), whereby the collected blood flows through the tube 15 and is introduced into the blood storage portion 13 of the blood collection bag 10.

According to the present embodiment, the same effects as those of the first embodiment described above can be obtained.
And in this embodiment, compared with the case where a clamp or the like capable of opening and closing the flow path is used as the first sealing means, there is no forgetting to close the clamp, so that the blood collection bag 10 is more mixed with the initial blood collection flow. It can be surely prevented.

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 was collected (sampled) in the reduced pressure blood collection tube 85 by the method described above, 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 1)
A blood collecting instrument having substantially the same structure as that of Example 1 was prepared except that the branch connector 32, the tube 31, the clamp 33 and the bag 20 were omitted. Using this blood collection device, the initial blood collection was collected (sampled) in the reduced pressure blood collection tube 85 in the same manner as in Example 1 except for the operation of the clamp 33, and then 200 ml of blood was collected in the blood collection bag 10. Collected. 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 in Example 1 was prepared except that the branch connector 92, the tube 91, the sealing member 93, the branch connector 32, the tube 31, the clamp 33, 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 both cases of Example 1 and Comparative Examples 1 and 2, the Yersinia enterocolitica bacterial solution (phosphate buffer suspension: A concentration of 100 cfu / ml) was applied with a cotton swab. In addition, the planned puncture site was not washed until blood collection.

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

[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 Example 1, when sampling the initial blood flow into the vacuum blood collection tube, the tube from the blood collection needle to the sampling port could be almost filled with blood. In this state, the blood was sampled by attaching the reduced pressure blood collection tube, so that the blood did not enter and remain on the side of the clamp 16 at the branch connector 92. For this reason, all of the initial blood collection from the collected blood. Was almost completely removed, and thus the number of bacteria detected was 0, as shown in Table 1 above.

  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 Example 1 and Comparative Examples 1 and 2, 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 Example 1, when sampling the initial blood flow into the vacuum blood collection tube, the tube from the blood collection needle to the sampling port could be almost filled with blood. Since blood was sampled by attaching a vacuum blood collection tube in this state, no excessive load is applied to the blood, and thus hemolysis does not occur as shown in Table 2 above. That is, in Example 1, there were 0 cases of slight hemolysis (level 1) and hemolysis (level 2).

  In Example 1, since the blood was sampled by attaching a vacuum blood collection tube in a state where the tube from the blood collection needle to the sampling port was almost filled with blood, as shown in Table 2 above, the sample amount was almost Does not decrease.

  In contrast, in Comparative Example 1, hemolysis was observed. That is, there were two 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. The sample volume was reduced by 3.5 ml. Note that the decrease in the sample amount in Comparative Example 1 corresponds to the spatial volume of the tube length of 35 cm.

  As mentioned above, although the blood collection instrument of the present invention has been described based on the illustrated embodiment, the present invention is not limited to this, and the configuration of each part is replaced with an arbitrary configuration having the same function. can do. Moreover, other arbitrary structures and processes may be added to the present invention.

  For example, in the present invention, the tube (second tube) 91 may be provided with a check valve (backflow prevention means) 94.

  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 portion of the short tube 940, and the branch connector 32 is liquid-tightly connected to the proximal end portion of the short tube 940.

  The valve main body 941 communicates with the branch connector 32 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 members 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 distal end side to the proximal 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, but flows only from the branch connector 92 to the sampling port 71 side.

  In the present invention, the position of the check valve 94 is not particularly limited as long as it is the tube 91, but the position of the check valve 94 is preferably on the sampling port 71 side from the branch connector 32 as described above, More preferably between the port 71.

  When the check valve 94 is installed at the above position, the blood can be introduced more smoothly because the check valve 94 does not become pressure resistance when blood reaches the vicinity of the branch connector 32.

  In the present invention, the sampling port 71 and the tube 31 may be connected to both branch ends of the branch connector 32 so as to be opposite to each other. That is, the tube 31 is connected to the upper branch end of the branch connector 32 in FIGS. 1 and 5, and the sampling port 71 is connected to the lower branch end of the branch connector 32 in FIGS. 1 and 5. Good.

  Further, in the present invention, each branch portion is not limited to the branch connector as shown in the figure, and may be constituted by a 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.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1, 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 20 Bag 21 Bag main body 22 Seal part 23 Storage Part 31 tube 32 branch connector 33 clamp 61 tube 71 sampling port 73 connector main body 731 distal end 732 base end 74 rib 76 cap 77 plug 82 holder 83 holder main body 84 double-ended needle 841 luer adapter 85 decompression blood collection tube 86 blood collection tube main body 87 rubber Plug 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 94 2 Hollow part 943 Tapered surface 944 Opening and closing member 95 Sealing member

Claims (8)

A blood collection needle to collect blood from a donor;
A blood collection bag containing an anticoagulant in advance and storing the 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 into the blood collection bag;
Branching from the first tube via a first branching section, and having a second tube having a blood outlet.
Prior to guiding the collected blood to the blood collection bag, the blood collection device removes the initial blood collection from the collected blood by guiding the blood to the second tube,
The blood collection instrument is provided between the first branch portion and the blood collection bag and in the vicinity of the first branch portion, blocks the flow path in the first tube, and breaks. Then, a breakable first sealing means for opening the flow path in the first tube;
A blood collection device comprising a bag provided on the second tube and collecting air.   The blood collection instrument has a third tube branched from the second tube via a second branch, and the bag for collecting the air is provided at an end of the third tube. The blood collection device according to claim 1.   The blood sampling device according to claim 2, further comprising a third sealing unit capable of blocking a flow path in the third tube.   The blood collection device according to any one of claims 1 to 3, wherein a capacity of the bag for collecting the air is 1 to 100 ml.   The blood sampling device according to any one of claims 1 to 4, further comprising a second sealing unit capable of blocking a flow path in the second tube.   The backflow prevention means which is provided in the said 2nd tube, enables the flow from the said 1st branch part to the said extraction port, and blocks | prevents the flow of the reverse direction in any one of Claim 1 thru | or 5 The blood sampling device described.   The blood collection device according to any one of claims 1 to 6, wherein an area of a cross section of the flow path in the second tube is set smaller than an area of a cross section of the flow path in the first tube. .   The blood collection device according to any one of claims 1 to 7, wherein the blood outlet is constituted by a connector.

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