WO2015141422A1

WO2015141422A1 - Blood collecting device and method of manufacturing blood collecting device

Info

Publication number: WO2015141422A1
Application number: PCT/JP2015/055500
Authority: WO
Inventors: 隆慶八尾
Original assignee: テルモ株式会社
Priority date: 2014-03-18
Filing date: 2015-02-26
Publication date: 2015-09-24
Also published as: JPWO2015141422A1; JP6377133B2; CN106102689B; CN106102689A

Abstract

A blood collecting device includes a blood collecting bag for storing collected blood, a tube connected at one end to an end connecting member for releasably sealing the one end and connected at the other end to the blood collecting bag, and a medicinal solution in the blood collecting bag and the tube. Space is formed in the one end of the tube, and the space has a width of from 10mm to 80mm in the center axis direction of the tube.

Description

Blood collection device and method for producing blood collection device

The present invention relates to a blood collection device having a blood collection bag for storing blood collected from a blood collection needle through a tube, and a method for manufacturing the blood collection device.

In Patent Documents 1 and 2, a blood collection needle for collecting blood from a donor, a blood collection bag for storing the collected blood, one end connected to a blood collection bag and the other end to a blood collection needle or a sealing member, A blood collection device having a tube for introducing the collected blood into a blood collection bag is disclosed.

JP 2004-89495 A Japanese Patent Laid-Open No. 2001-17539

However, the blood collection device as described above is manufactured by filling a blood collection bag and a tube with a chemical solution such as an anticoagulant, a blood preservation solution, or a red blood cell preservation solution. When a blood collection needle or a sealing member is connected to the tube to close the tube, the operator may accidentally crush the tube. Then, the drug solution leaks from the tube and flows into a hub or sealing member that connects the blood collection needle and the tube, or attaches to the operator's hand, thereby adhering to the outer surface of the blood collection device. There is a fear.

Here, glucose is contained in the above chemical solution. Therefore, when the blood collection device is subsequently sterilized and stored, the chemical solution adhering to the hub or the sealing member is dried or the chemical solution adhering to the outer surface of the blood collection device is dried. There is a possibility that. When incorporating a drug-containing tube into a system that is manufactured as a product with the drug introduced in this way, the drug solution adheres to the hub or sealing member of the blood collection needle or the outer surface of the blood collection device, and the adhesion When the phenomenon that the portion is discolored occurs, the appearance is poor, and the commercial value of the blood collection device is reduced. Since such a product is not a product, the yield of the product is reduced. In addition, it is not preferable from the viewpoint of hygiene that the chemical solution adheres to the outer surface of the blood sampling device.

Therefore, the present invention has been made to solve the above-described problems, and provides a blood collection instrument and a method for producing the blood collection instrument that can prevent the occurrence of defects such as poor appearance during production, With the goal.

One aspect of the present invention made to solve the above problems is that a blood collection bag for storing collected blood, an end connection member whose one end is openably sealed, and the other end is A tube connected to the blood collection bag, and in a blood collection instrument having a drug solution in the blood collection bag and in the tube, a space is formed inside one end of the tube, The width of the tube in the central axis direction is 10 mm to 80 mm.

According to this aspect, the space is sufficiently formed inside one end of the tube. Therefore, when an end connection member is connected to one end of the tube at the time of manufacturing a blood collection device, even if an operator accidentally crushes the tube, the liquid medicine injected into the tube leaks from the tube. There is no risk of adhering to the inside of the end connection member or the outer surface of the blood collection device. Therefore, it is possible to prevent problems such as poor appearance during the production of the blood sampling device. Therefore, the yield of the product for blood collection is improved.

In the above aspect, the end connection member preferably includes a blood collection needle and a hub that connects the tube and the blood collection needle.

According to this aspect, it is possible to prevent the occurrence of problems such as poor appearance during the manufacture of a blood collection device in which the hub and the blood collection needle are directly connected to the tube connected to the blood collection bag.

In the above aspect, the end connection member includes a sealing member connected to the tube and a first tube connected to the sealing member, and the sealing member includes the tube and the first It is preferable that the tube can be blocked and communicated.

According to this aspect, it is possible to connect to various members via the sealing member, and it is possible to prevent problems such as poor appearance during the production of blood collection instruments having various configurations.

Another aspect of the present invention made to solve the above-described problems is that a blood collection bag for storing collected blood and an end connection member whose one end is openably sealed, and the other end In the method for manufacturing a blood collection device having a drug solution in the blood collection bag and in the tube, the injection nozzle inserted into one end of the tube One end portion of the tube while the chemical solution is injected into the blood collection bag and the inside of the tube, and the tube is crushed by the first gripping tool so as to be crushed in the radial direction of the tube. In the suck back process in which the inside of the tube is sucked under reduced pressure, and the injection nozzle is retracted from one end of the tube, a space is formed inside the one end of the tube. The nozzle retracting step is performed and the tube is released from the state of being gripped by the first gripping tool, while the width of the tube in the central axis direction is the center gripping direction of the tube in the first gripping tool. A chuck gripping step in which the tube is gripped by a second gripping tool smaller than the width so as to be crushed in the radial direction of the tube, whereby the width of the tube in the central axis direction is increased; An end connecting member connecting step in which the end connecting member is connected to one end of the tube while the tube is held by two gripping tools.
Still further, in the above aspect, the width of the space is 10 mm to 80 mm when the chuck holding step is completed.

According to these aspects, a sufficient space is formed inside the one end portion of the tube when the chuck holding step is completed. Therefore, even if the operator accidentally crushes the tube when the end connection member connection step is performed, the chemical injected into the tube leaks out of the tube and is used in the end connection member or for blood collection. There is no risk of sticking to the outer surface of the instrument. For this reason, it is possible to prevent the occurrence of defects such as poor appearance during the manufacture of the blood sampling device. Therefore, the yield of the product for blood collection is improved.

In the above aspect, in the chuck re-holding step, the timing at which the tube is released from the state of being gripped by the first gripping tool is the same as the timing at which the tube is gripped by the second gripping tool, or It is preferable that it is after the timing when the tube is gripped by the second gripping tool.

According to this aspect, in the chuck grip replacement step, the chemical solution injected into the tube can be reliably replaced from the first gripper to the second gripper without leaking from the tube. .

In the above aspect, it is preferable that (the width in the central axis direction of the tube in the first gripping tool) − (width in the central axis direction of the tube in the second gripping tool) = 5 mm to 75 mm.

According to this aspect, the width of the space inside the tube is more effectively expanded in the chuck re-holding process.

According to the blood collecting instrument and the method for producing a blood collecting instrument of the present invention, it is possible to prevent the occurrence of problems such as poor appearance when the blood collecting instrument is manufactured.

1 is a plan view of a blood collection device of Example 1. FIG. In the blood collection instrument of Example 1, it is an enlarged view of the periphery of the one end part of a tube. It is a figure which shows a chemical | medical solution injection | pouring process. It is a figure which shows a suck back process. It is a figure which shows a nozzle backward process. It is a figure which shows a chuck | zipper grasp replacement process. It is a figure which shows a blood collection needle | hook connection process. It is a figure which shows a modification. 6 is a plan view of a blood collection device of Example 2. FIG. In the blood collection instrument of Example 2, it is an enlarged view of the periphery of the one end part of a tube. It is a figure which shows a sealing member connection process.

[Example 1]
<Configuration of blood collection device>
As shown in FIG. 1, the blood collection instrument 1 of this embodiment includes a blood collection bag 10, a tube 12, a sealing member 14, a tube 16, a hub 18, a blood collection needle 20, a cap 22, and the like. . The hub 18 fixes the blood collection needle 20 and is connected to the tube 12. When the cap 22 covers the blood collection needle 20, the tube 12 is sealed. In the present embodiment, the hub 18, the blood collection needle 20 and the cap 22 constitute an example of the “end connection member” of the present invention.

The blood collection bag 10 is a bag for storing collected blood. The blood collection bag 10 has a bag body 30 configured in a bag shape. The bag body 30 is formed by stacking resin-made flexible sheet materials and fusing (thermal fusing, high-frequency fusing, etc.) or bonding at the peripheral seal portion 32. A blood storage portion 34 for storing blood sampled blood is formed in an inner portion surrounded by the seal portion 32 of the bag body 30. In the blood storage portion 34, the liquid chemical liquid 24, which is a chemical liquid, is stored (accommodated). Examples of the drug solution 24 include ACD (acid citrate dextrose), CPD solution (cytolate phosphate dextrose), MAP solution, SAGM solution, OPTISOL solution, and the like. The amount of the drug solution 24 is adjusted to an appropriate amount according to the planned blood collection amount.

Further, the bag body 30 has a discharge port 36 at the top thereof. The discharge port 36 is sealed so that it can be opened, and two discharge ports 36 are provided. A sealing member 14 is provided on the side of one discharge port 36. The sealing member 14 is connected to one end of a tube 16 having flexibility. Furthermore, the bag body 30 is connected to the other end portion 12b of the tube 12 having flexibility. Note that the inside of each of the discharge port 36, the tube 12, and the sealing member 14 communicates with the blood storage portion 34.

The tube 12 is connected to the blood collection needle 20 through the hub 18 at one end 12a. Further, the tube 12 is connected at the other end 12b so as to communicate with the bag body 30 of the blood collection bag 10. The tube 12 is formed in a cylindrical shape, and has a flow path for introducing blood collected by the blood collection needle 20 into the blood collection bag 10 therein. The chemical solution 24 is injected into the tube 12. The tube 12 is an example of the “tube” in the present invention.

The hub 18 is connected to the tube 12 and the blood collection needle 20. The hub 18 is fitted with a cap 22 that covers the blood collection needle 20 and can be opened by removing the cap 22.

These tubes 12, hub 18, blood collection needle 20 and cap 22 constitute a blood collection line.

It should be noted that one or more bags such as a plasma bag (not shown), a buffy coat bag, a platelet bag (medicine solution storage bag), and the like may be provided on the other end side of the tube 16. That is, the blood collection instrument 1 may constitute a bag connector.

Next, the sheet material constituting the blood collection bag 10, the constituent material of the tube 12, the constituent material of the tube 16, and the like will be described.

The composition, characteristics, etc. of the sheet material constituting the bag body 30 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.

Examples of the constituent material of the tube 12 and the tube 16 include thermoplastic elastomers such as soft polyvinyl chloride, polyethylene, polypropylene, ethylene-vinyl acetate copolymer, styrene-butadiene-styrene copolymer, and the like. Among them, soft polyvinyl chloride or a material mainly composed of this is 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.

<Operation of blood collection device>
Next, a blood processing method using the blood collection device 1 will be described as an action of the blood collection device 1. First, the cap 22 is removed from the hub 18 and puncture is performed with a blood collection needle 20 into a vein (blood vessel) of a donor (blood donor). Thereby, the collected blood flows through the tube 12 and is introduced into the blood storage part 34 in which the drug solution 24 is injected in the blood collection bag 10. In this way, blood is collected in the blood collection bag 10.

<Configuration of one end of the tube>
Next, the configuration of the one end portion 12a of the tube 12 will be described. As shown in FIG. 2, the drug solution 24 is injected into the tube 12, but an air replacement unit 40, which is a space, is provided inside the one end 12 a connected to the blood collection needle 20 via the hub 18. Is formed. The air replacement part 40 is formed from the tip of the end 12a of the tube 12 to which the blood collection needle 20 is connected (right side in FIG. 2) to the other end 12b side (left side in FIG. 2). As an example, the width Δ of the one end portion 12a is 80 mm, and the width δ of the air replacement portion 40 is 10 mm to 80 mm. Both the width Δ and the width δ are widths in the central axis direction of the tube 12 (left and right direction in FIG. 2).

The width δ in the axial direction of the air replacement part 40 is preferably 10 mm to 80 mm, and more preferably 15 mm to 60 mm. When the width δ is shorter than the lower limit value of the above range, the possibility that the chemical solution in the tube 12 is scattered outside increases, and when the width δ is longer than the upper limit value of the above range, the manufacturing apparatus becomes large.

As described above, the tube 12 includes the air replacement portion 40 in the region of the one end portion 12a defined by the width Δ.

<Method for manufacturing blood sampling device>
Next, a method for injecting the drug solution 24 into the blood collection bag 10 and the tube 12 and then connecting the blood collection needle 20 to the tube 12 will be described as a method for manufacturing the blood collection instrument 1. In this embodiment, the chuck CH1, the chuck CH2, the chuck CH3, and the injection nozzle N are used when the blood collection instrument 1 is manufactured. As an example, the width L1 of the chuck CH1 is 7 mm, the width L2 of the chuck CH2 is 7 mm, the width L3 of the chuck CH3 is 2 mm, and the width LN of the injection port Na of the injection nozzle N is 5 to 7 mm. The width L1, the width L2, the width L3, and the width LN are all widths in the central axis direction of the tube 12.

In addition, each operation | movement of chuck | zipper CH1, chuck | zipper CH2, chuck | zipper CH3, and the injection | pouring nozzle N may be automatically controlled by the control part not shown. Further, the chuck CH1 and the chuck CH2 are examples of the “first gripping tool” of the present invention, and the chuck CH3 is an example of the “second gripping tool” of the present invention.

Further, the sizes of the width L1, the width L2, and the width L3 are not particularly limited to the above numerical values and can be changed. As an example, the width L1, the width L2, and the width L3 may be defined so as to satisfy the condition of (L1 + L2) −L3 = 5 mm to 75 mm. Thus, the width L3 of the chuck CH3 is smaller than the total width of the width L1 of the chuck CH1 and the width L2 of the chuck CH2.

Therefore, first, a chemical injection process is performed. Specifically, as shown in FIG. 3, the injection port Na of the injection nozzle N is inserted into the one end portion 12 a of the tube 12. Then, the drug solution 24 is injected into the blood storage part 34 of the blood collection bag 10 through the tube 12 from the injection port Na of the injection nozzle N. As a result, the drug solution 24 is injected into the blood collection bag 10 and the tube 12.

Next, a suck back process is performed. Specifically, as shown in FIG. 4, the tube 12 is gripped by the chuck CH <b> 1 and the chuck CH <b> 2 so as to be crushed in the radial direction of the tube 12. Further, the inside of the tube 12 is sucked under reduced pressure through the injection nozzle N at one end 12 a of the tube 12.

Next, a nozzle retracting process is performed. Specifically, as shown in FIG. 5, the injection port Na of the injection nozzle N is removed from the inside of the one end 12 a of the tube 12 and retreats. Thereby, the air replacement part 40 which is space is formed inside the one end part 12 a of the tube 12. The air replacement section 40 is formed from the tip of the end 12a of the tube 12 to which the blood collection needle 20 is connected (right side in FIG. 5) to the other end 12b side (left side in FIG. 5). At this time, the width δ of the air replacement section 40 is, for example, 5 mm to 7 mm. The width δ is the width of the tube 12 in the central axis direction (left-right direction in FIG. 5).

Next, a chuck grip replacement process is performed. Specifically, as shown in FIG. 6, while the tube 12 is released from the state of being gripped by the chuck CH1 and the chuck CH2, the tube 12 is crushed in the radial direction of the tube 12 by the chuck CH3. Grasped. Here, the timing at which the tube 12 is released from the state of being gripped by the chuck CH1 and the chuck CH2 is the same as the timing at which the tube 12 is gripped by the chuck CH3, or the timing at which the tube 12 is gripped by the chuck CH3. Later.

And the width | variety of the air replacement part 40 expands by performing such a chuck holding | grip replacement process. For example, the width δ of the air replacement unit 40 is 10 mm to 80 mm when the chuck grip replacement process is completed. Here, as a comparative example, when the chuck holding step is not performed, the width δ of the air replacement unit 40 is less than 10 mm. Thus, the width δ of the air replacement unit 40 can be increased by performing the chuck re-holding step as compared to the case where the chuck re-holding step is not performed.

Next, a blood collection needle connecting step is performed. Specifically, as shown in FIG. 7, while the tube 12 is gripped by the chuck CH3, the blood collection needle 20 to which the cap 22 is connected is connected to the one end portion 12a of the tube 12 via the hub 18. Thereby, as shown in FIG. 2, the blood collection needle 20 and the cap 22 are connected to the one end portion 12 a of the tube 12 through the hub 18. The blood collection needle connecting step is an example of the “end connecting member connecting step” in the present invention.

As described above, the drug solution 24 is injected into the blood collection bag 10 and the tube 12, and then the blood collection needle 20 can be connected to the tube 12. Then, after that, the tube 12 is released from the state of being gripped by the chuck CH3, whereby the configuration of the one end portion 12a of the tube 12 is as shown in FIG. At this time, the width δ of the air replacement part 40 is 10 mm to 80 mm.

As shown in FIG. 8, as a modification, instead of using the chuck CH1 and the chuck CH2 as described above, one chuck CHX may be used. At this time, the width LX in the central axis direction of the tube 12 in the chuck CHX is the same as the total width of the width L1 of the chuck CH1 and the width L2 of the chuck CH2. As an example, the width LX of the chuck CHX is 14 mm. The chuck CHX is an example of the “first gripper” in the present invention.

In the blood collection device 1 of the present embodiment, the air replacement part 40 is formed inside the one end part 12a of the tube 12, and the width δ of the air replacement part 40 is 10 mm to 80 mm. As described above, the air replacement portion 40 is sufficiently formed inside the one end portion 12 a of the tube 12. Therefore, when the blood collection needle 20 is connected to the one end portion 12a of the tube 12 via the hub 18 when the blood collection device 1 is manufactured, even if the operator accidentally crushes the tube 12, it is injected into the tube 12. There is no possibility that the drug solution 24 leaked from the tube 12 and adheres to the outer surface of the blood sampling device 1. Therefore, it is possible to prevent the occurrence of problems such as poor appearance when the blood collecting instrument 1 is manufactured. Therefore, the product yield of the blood collection instrument 1 is improved.

Further, the end connection member in the blood collection instrument 1 includes a blood collection needle 20, a hub 18 that connects the tube 12 and the blood collection needle 20, and a cap 22. In this way, it is possible to prevent problems such as poor appearance during the production of the blood collection instrument 1 in which the hub 18 and the blood collection needle 20 are directly connected to the tube 12 connected to the blood collection bag 10.

In the method of manufacturing the blood sampling instrument 1 of the present embodiment, a chemical solution injection process, a suck back process, a nozzle retraction process, a chuck grip replacement process, and a blood sampling needle connection process are performed, and the chuck grip replacement process ends. In this case, the width δ of the air replacement part 40 is 10 mm to 80 mm. As described above, when the chuck gripping replacement process is completed, the air replacement portion 40 is sufficiently formed inside the one end portion 12 a of the tube 12. Therefore, even if the operator accidentally crushes the tube 12 when the blood collection needle connecting step is performed, the drug solution 24 injected into the tube 12 leaks from the tube 12 and the outer surface of the blood collection device 1. There is no risk of sticking to. Therefore, it is possible to prevent the occurrence of problems such as poor appearance when the blood collecting instrument 1 is manufactured. Therefore, the product yield of the blood collection instrument 1 is improved.

Further, in the chuck grip changing step, the timing at which the tube 12 is released from the state of being gripped by the chuck CH1 and the chuck CH2 is the same as the timing at which the tube 12 is gripped by the chuck CH3, or the tube 12 is gripped by the chuck CH3. Later than the timing. Thereby, in the chuck re-holding step, the chemical liquid 24 injected into the tube 12 does not leak from the tube 12, and the chuck CH1 and the chuck CH2 are reliably re-gripped to the chuck CH3, or the chuck CHX. To the chuck CH3.

Also, (LH1-LH2) −LH3 = 5 mm to 75 mm. As a result, the width δ of the air replacement portion 40 inside the tube 12 is more effectively expanded in the chuck re-holding step.

[Example 2]
Next, the second embodiment will be described. The same components as those of the first embodiment are denoted by the same reference numerals, the description thereof will be omitted, and different points will be mainly described.

<Configuration of blood collection device>
As shown in FIG. 9, the blood collection device 2 of Example 2 is different from the blood collection device 1 of Example 1 in that the sealing member 50, the branch connector 52, the tube 54, the tube 56, and the clamp 58, a temporary storage bag 60, a tube 62, a sampling port 64, and the like. In the blood sampling instrument 2, the sealing member 50 is connected to the one end 12 a of the tube 12.

In this embodiment, the sealing member 50, the branch connector 52, the tube 54, the hub 18, the blood collection needle 20, the cap 22, the tube 56, the clamp 58, the temporary storage bag 60, and the tube 62 and the sampling port 64 constitute an example of the “end connection member” of the present invention.

The sealing member 50 is connected to the tube 12 so that it can be opened. The sealing member 50 has a structure as shown in FIG. 10, and can block and communicate between the tube 12 and the tube 54.

As shown in FIG. 10, the sealing member 50 includes a short tube 70 and a cylindrical body 72. The short tube 70 is made of a flexible resin such as soft polyvinyl chloride. The cylindrical body 72 is closed at one end by a solid columnar portion 74.

One end portion 12a of the tube 12 is connected to the left end portion of the short tube 70 in FIG. Further, the tube 54 is connected to the right end of the short tube 70 in FIG. In the state shown in FIG. 10, the tube 12 and the tube 54 are blocked by the cylindrical body 72.

A thin and fragile fracture portion 76 is formed on the outer periphery of the cylindrical body 72. When the broken column 76 is broken by folding the solid columnar portion 74 together with the short tube 70 from the outside of the short tube 70 with fingers or the like, the solid columnar portion 74 is separated from the cylindrical body 72. As a result, the tube 12 and the tube 54 communicate with each other.

Returning to the description of FIG. 9, the branch connector 52 is connected to a tube 54 and a tube 56. The tube 54 is connected to the blood collection needle 20 through the hub 18 at one end thereof. The tube 54 is connected to the sealing member 50 at the other end. The tube 54 is an example of the “first tube” in the present invention. The hub 18 connects the tube 54 and the blood collection needle 20. Further, the tube 54 may be connected at one end thereof to various bags such as a bag containing a red blood cell storage solution.

The tube 56 branches off from the tube 54 at the branch connector 52 portion at one end thereof. The tube 56 is connected to the temporary storage bag 60 via the clamp 58 at the other end. The tube 56 is an example of the “second tube” in the present invention.

The temporary storage bag 60 is a bag that is connected to the other end of the tube 56 and temporarily stores the collected blood. This temporary storage bag 60 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 (heat fusion, high frequency fusion, etc.) at the peripheral seal portion 80. Or a bag body 82 which is bonded to form a bag.

The tube 62 has a temporary storage bag 60 connected to one end and a sampling port (connector) 64 connected to the other end. The sampling port 64 is connected to, for example, a holder of a decompression blood collection tube (container) (not illustrated) (a blood collection device for decompression blood collection tube). Collected in a vacuum blood collection tube.

<Operation of blood collection device>
Next, a blood processing method using the blood collection device 2 will be described as an action of the blood collection device 2.

First, the cap 22 is removed from the hub 18 and puncture is performed with a blood collection needle 20 into a vein (blood vessel) of a donor (blood donor). At this time, since the space between the tube 12 and the tube 54 is blocked by the sealing member 50, blood flows from the tube 54 to the tube 56 through the branch connector 52. Thereby, the initial blood flow (blood) flows through the blood collection needle 20, the tube 54, and the branch connector 52, flows into the tube 56, and is introduced into the temporary storage bag 60. Thus, after a predetermined amount of blood is collected (collected) in the temporary storage bag 60, the tube 56 is closed by the clamp 58, and the flow path of the tube 56 is closed (blocked).

Next, when the broken portion 76 of the sealing member 50 is broken by bending the solid columnar portion 74 together with the short tube 70 from the outside of the short tube 70 as described above, the tube 12 and the tube 54 communicate with each other. . Thereby, the collected blood flows through the tube 54 and the tube 12 and is introduced into the blood storage part 34 of the blood collection bag 10. In this way, blood is collected in the blood collection bag 10.

<Configuration of one end of the tube>
Next, the configuration of the one end portion 12a of the tube 12 will be described. As shown in FIG. 10, the chemical liquid 24 is injected into the tube 12, but an air replacement portion 40 that is a space is formed inside the one end portion 12 a connected to the sealing member 50. . For example, the width Δ of the one end portion 12a is 80 mm, and the width δ of the air replacement portion 40 is 10 mm to 80 mm.

<Method for manufacturing blood sampling device>
In the present embodiment, as a difference from the first embodiment, a sealing member connecting step is performed instead of the blood collection needle connecting step. Specifically, as shown in FIG. 11, the sealing member 50 is connected to the one end portion 12a of the tube 12 while the tube 12 is gripped by the chuck CH3. Thereby, as shown in FIG. 9, the blood collection needle 20 and the temporary storage bag 60 are connected to the one end portion 12 a of the tube 12 via the sealing member 50. The sealing member connecting step is an example of the “end connecting member connecting step” in the present invention.

Here, as described above, the blood collecting device 1 and the blood collecting device 2 manufactured by injecting the drug solution 24 into the blood collecting bag 10 and the tube 12 and then connecting the blood collecting needle 20 to the tube 12 are sterilized, The occurrence of appearance defects was evaluated. Then, 200 sets of evaluations were performed on the blood sampling device 1 and 100 sets of evaluations were performed on the blood sampling device 2, but no appearance defects occurred.

In the blood sampling device 2 of the present embodiment, the air replacement part 40 is formed inside the one end part 12a of the tube 12, and the width δ of the air replacement part 40 is 10 mm to 80 mm. As described above, the air replacement portion 40 is sufficiently formed inside the one end portion 12 a of the tube 12. Therefore, when the sealing member 50 is connected to the one end portion 12a of the tube 12 at the time of manufacturing the blood collection device 2, the drug solution injected into the tube 12 even if the operator accidentally crushes the tube 12 There is no fear that 24 leaks out of the tube 12 and adheres to the outer surface of the blood collection device 2. Therefore, it is possible to prevent the occurrence of problems such as poor appearance when the blood collecting instrument 2 is manufactured. Therefore, the product yield of the blood sampling device 2 is improved.

Further, the end connection member of the blood sampling instrument 2 includes a sealing member 50 connected to the tube 12 and a tube 54 connected to the sealing member 50, and the sealing member 50 includes the tube 12 and the tube 54. Can be blocked and communicated with each other. In this way, the one end portion 12a of the tube 12 can be connected to various members via the sealing member 50, and problems such as poor appearance occur at the time of manufacturing the blood sampling device 2 having various configurations. Can be prevented.

The manufacturing method of the blood sampling instrument 2 of the present embodiment includes a chemical solution injection process, a suck back process, a nozzle retraction process, a chuck grip replacement process, and a sealing member connection process. When finished, the width δ of the air replacement part 40 is between 10 mm and 80 mm. As described above, when the chuck gripping replacement process is completed, the air replacement portion 40 is sufficiently formed inside the one end portion 12 a of the tube 12. Therefore, even if an operator accidentally crushes the tube 12 when the sealing member connecting step is performed, the drug solution 24 injected into the tube 12 leaks out of the tube 12 and the blood collecting instrument 2 There is no risk of adhering to the outer surface. Therefore, it is possible to prevent problems such as poor appearance during the production of the blood sampling device 2. Therefore, the product yield of the blood sampling device 2 is improved.

It should be noted that the above-described embodiment is merely an example, and does not limit the present invention in any way, and various improvements and modifications can be made without departing from the scope of the invention.

DESCRIPTION OF SYMBOLS 1 Blood collection instrument 2 Blood collection instrument 10 Blood collection bag 12 Tube 12a One end part 18 Hub 20 Blood collection needle 22 Cap 24 The said chemical | medical solution 40 Air replacement part 50 Sealing member 60 Temporary storage bag CH1 Chuck CH2 Chuck CH3 Chuck CHX Chuck N Injection nozzle Na Inlet Δ (Width of one end) δ (Air replacement portion) Width L1 (Chuck CH1) Width L2 (Chuck CH2) Width L3 (Chuck CH3) Width LX (Chuck CHX) Width LN (Injection nozzle) Width of tip

Claims

A blood collection bag for storing the collected blood, a tube connected to an end connection member whose one end is sealed so as to be openable, and a tube connected to the blood collection bag at the other end. In a blood collection instrument having the inside of the blood collection bag and the inside of the tube,
A space is formed inside one end of the tube,
The width of the space in the central axis direction of the tube is 10 mm to 80 mm;
A blood sampling device characterized by
The blood collection device of claim 1,
The end connection member includes a blood collection needle, and a hub for connecting the tube and the blood collection needle;
A blood sampling device characterized by
The blood collection device of claim 1,
The end connection member includes a sealing member connected to the tube, and a first tube connected to the sealing member,
The sealing member is capable of blocking and communicating between the tube and the first tube;
A blood sampling device characterized by
A blood collection bag for storing the collected blood, a tube connected to an end connection member whose one end is sealed so as to be openable, and a tube connected to the blood collection bag at the other end. In the method for producing a blood collection device having the inside of the blood collection bag and the inside of the tube,
A chemical solution injection step in which the chemical solution is injected into the blood collection bag and the tube from an injection nozzle inserted into one end of the tube;
A suckback step in which the inside of the tube is sucked under reduced pressure at one end of the tube while the tube is gripped by the first gripping tool so as to be crushed in the radial direction of the tube;
A nozzle retreating step in which a space is formed inside one end of the tube by retreating the injection nozzle from one end of the tube;
The second gripping tool is released from the state in which the tube is gripped by the first gripping tool, and the width in the central axis direction of the tube is smaller than the width in the central axis direction of the tube in the first gripping tool. The chuck is replaced so that the tube is crushed in the radial direction of the tube so that the width in the central axis direction of the tube in the space increases, and
An end connection member connecting step in which the end connection member is connected to one end of the tube while the tube is gripped by the second gripping tool,
A method for producing a blood sampling device characterized by the above.
In the manufacturing method of the instrument for blood collection of Claim 4,
The width of the space is 10 mm to 80 mm when the chuck re-holding process is completed;
A method for producing a blood sampling device characterized by the above.
In the manufacturing method of the blood collection instrument of Claim 4 or 5,
In the chuck grip changing step, the timing at which the tube is released from the state of being gripped by the first gripping tool is the same as the timing at which the tube is gripped by the second gripping tool, or the tube is 2 Be later than the timing of gripping by the gripping tool,
A method for producing a blood sampling device characterized by the above.
In the manufacturing method of the blood collection instrument according to any one of claims 4 to 6,
(Width in the central axis direction of the tube in the first gripping tool) − (width in the central axis direction of the tube in the second gripping tool) = 5 mm to 75 mm,
A method for producing a blood sampling device characterized by the above.
In the manufacturing method of the blood collection instrument any one of Claims 4 thru | or 7,
The end connection member includes a blood collection needle, and a hub for connecting the tube and the blood collection needle;
A method for producing a blood sampling device characterized by the above.
In the manufacturing method of the blood collection instrument any one of Claims 4 thru | or 7,
The end connection member includes a sealing member connected to the tube, and a first tube connected to the sealing member,
The sealing member is capable of blocking and communicating between the tube and the first tube;
A method for producing a blood sampling device characterized by the above.