WO2020059170A1

WO2020059170A1 - Blood collection set

Info

Publication number: WO2020059170A1
Application number: PCT/JP2019/007884
Authority: WO
Inventors: 秋山真洋; 永田剛大
Original assignee: テルモ株式会社
Priority date: 2018-09-18
Filing date: 2019-02-28
Publication date: 2020-03-26
Also published as: CN112654375A; JP7250030B2; CN112654375B; JPWO2020059170A1

Abstract

A blood collection set (10) comprising a blood collection needle (12), a blood collection bag (20) for storing blood, a blood collection line (36) guiding blood collected from the blood collection needle (12) to the blood collection bag (20), a branching line (38) branching from the blood collection line (36), and an initial-flow blood bag (24) provided to the branching line (38) and for storing initial-flow blood during blood collection, wherein a fluid replacement port (26) for injecting a fluid infusion is provided to the blood collection line (36) so as to be closer to the blood collection needle (12) than the branching-off part for the branching line (38) is.

Description

Blood collection set

{Circle over (1)} The present invention relates to a blood collection set including an initial blood bag for storing initial blood at the time of blood collection.

For example, Japanese Patent No. 4030682 discloses a blood collection set including a blood collection line for guiding blood collected from a blood collection needle to a blood collection bag, and a first-flow blood bag provided on a branch line branched from the blood collection line. ing. According to such a blood collection set, it is possible to store the initial blood that is easily contaminated with bacteria present on the skin and subcutaneously in the initial blood bag, so that it is possible to prevent the bacteria from flowing into the blood collection bag.

By the way, in hospitals and the like, autologous blood transfusion for transfusion of blood that has been collected and stored in advance in preparation for bleeding during surgery is widely performed. In this case, since the donor is a non-healthy patient and it is necessary to maintain the circulating blood volume, an infusion such as saline is administered to the donor after autologous blood sampling, which collects his own blood used in surgery (replacement fluid) I do.

At this time, it is preferable to administer the infusion to the donor using a blood collection needle, but it is necessary to prevent the initial blood from being administered to the donor together with the infusion.

The present invention has been made in view of such problems, and a blood collection set capable of administering an infusion solution to a donor via a blood collection needle while preventing initial blood from returning to the donor. The purpose is to provide.

An embodiment of the present invention provides a blood collection needle, a blood collection bag for containing blood, a blood collection line for guiding blood collected from the blood collection needle to the blood collection bag, a branch line branched from the blood collection line, and the branch A first-flow blood bag for storing first-flow blood at the time of blood collection; anda blood-collecting needle side of the blood-collection line with respect to the blood-collecting needle side, for injecting an infusion solution. This is a blood collection set provided with a fluid replacement port.

According to the blood collection set of the present invention, the replacement fluid port is provided on the blood collection needle side of the branch line of the blood collection line, so that the first-flow blood present in the branch line and the first-flow blood bag is returned to the donor. Infusion can be administered to the donor via a blood collection needle while preventing blood pressure.

It is the schematic of the blood collection set which concerns on one Embodiment of this invention. It is explanatory drawing of the state which connected the infusion set to the blood collection set. It is a 1st explanatory view of blood collection using a blood collection set. It is the 2nd explanatory view of the blood collection using the blood collection set. It is an explanatory view of administration of an infusion solution using a blood collection set. It is explanatory drawing of the branch connector which concerns on a modification.

Hereinafter, a preferred embodiment of the blood collection set according to the present invention will be described with reference to the accompanying drawings.

The blood collection set 10 according to one embodiment of the present invention is for collecting blood (whole blood) from a donor 200 (see FIG. 3 and the like, a patient and the like), and thereafter administering an infusion agent to the donor 200. is there. Specifically, the blood collection set 10 is used, for example, at the time of autologous blood collection for collecting own blood used in surgery.

As shown in FIG. 1, a blood collection set 10 includes a blood collection needle 12, a first blood collection flow path member 14, a branch connector 16, a second blood collection flow path member 18, a blood collection bag 20, a branch tube 22, a first flow blood bag 24, and a replacement fluid. A port 26 (infusion port) is provided.

The blood collection needle 12 is configured to be able to puncture the skin of the donor 200 (see FIG. 3 and the like, a blood donor), and is made of, for example, a metal material such as stainless steel, aluminum or an aluminum alloy, titanium or a titanium alloy. The blood collection needle 12 is formed in a circular tube shape and has a hollow portion serving as a blood flow path. Before using the blood collection needle 12, the blood collection needle 12 is provided with a cap 28.

The first blood collection flow path member 14 is a soft tube that guides blood collected from the blood collection needle 12 to the branch connector 16. One end of the first blood collection flow path member 14 is connected to a base end (base end) of the blood collection needle 12.

The branch connector 16 is an integrally molded product of a hard resin material. The branch connector 16 has a connector main body 16a, a first connection port 16b, and a second connection port 16c. The connector main body 16a is formed in a tubular shape, and has a hollow portion through which blood flows. The other end of the first blood collection flow path member 14 is connected to one end of the connector main body 16a.

The first connection port 16b is a cylindrical portion that protrudes laterally from one end of the connector body 16a. The angle between the axis of the first connection port 16b and the axis of the connector body 16a is substantially a right angle. The second connection port 16c is a cylindrical portion that protrudes laterally from the other end of the connector body 16a. The angle between the axis of the second connection port 16c and the axis of the connector body 16a is substantially a right angle.

The first connection port 16b and the second connection port 16c protrude in the same direction from the connector main body 16a. In other words, the first connection port 16b and the second connection port 16c are arranged along the extending direction of the connector main body 16a. That is, the first connection port 16b and the second connection port 16c are provided in parallel with each other.

In the branch connector 16, the angle between the axis of the first connection port 16b and the axis of the connector main body 16a may be an acute angle. The angle between the axis of the second connection port 16c and the axis of the connector body 16a may be an acute angle. The first connection port 16b and the second connection port 16c may be provided to be shifted from each other in the circumferential direction of the connector main body 16a. That is, the first connection port 16b and the second connection port 16c may protrude from the connector main body 16a in directions opposite to each other, for example. Further, the first connection port 16b and the second connection port 16c do not need to protrude laterally from the connector main body 16a. That is, the first connection port 16b and the second connection port 16c may be provided in any manner with respect to the connector main body 16a.

The second blood collection flow path member 18 guides the blood that has flowed into the branch connector 16 from the blood collection needle 12 via the first blood collection flow path member 14 to the blood collection bag 20. One end of the second blood collection flow path member 18 is connected to the connector main body 16a, and the other end of the second blood collection flow path member 18 is connected to the blood collection bag 20. The second blood collection flow path member 18 includes a sealing member 30 and a connection tube 31.

The sealing member 30 is connected to the other end of the connector body 16a. The sealing member 30 is such that the flow path is closed in an initial state and the flow path is opened by performing a breaking operation. The connection tube 31 is a soft tube that guides the blood flowing through the sealing member 30 to the blood collection bag 20. One end of the connection tube 31 is connected to the sealing member 30, and the other end of the connection tube 31 is connected to the blood collection bag 20. The connection tube 31 is provided with a clamp 32 for closing and opening the flow path of the second blood collection flow path member 18. In other words, the clamp 32 is provided in the second blood collection flow path member 18 on the downstream side of the sealing member 30 (on the side of the blood collection bag 20).

The blood collection bag 20 is a soft bag for containing (retaining) blood collected from the donor 200. It is preferable that an anticoagulant is put in the blood collection bag 20 in advance. Examples of the anticoagulant include ACD-A solution, CPD solution, CPDA-1 solution, sodium heparin solution and the like. The amount of the anticoagulant is an appropriate amount according to the expected blood collection amount.

The branch tube 22 is a soft tube that guides the blood that has flowed into the branch connector 16 from the blood collection needle 12 via the first blood collection flow path member 14 to the initial flow blood bag 24. One end of the branch tube 22 is connected to the second connection port 16 c of the branch connector 16. The other end of the branch tube 22 is connected to the initial blood bag 24. The branch tube 22 is provided with a clamp 34 for closing the flow path of the branch tube 22.

The initial blood bag 24 is a soft bag for containing the initial blood at the time of blood collection. The first-flow blood bag 24 may be provided with a sampling port (not shown). In this case, the initial blood can be used for the test.

The fluid replacement port 26 is an infusion solution introduction portion for injecting the infusion solution, and is formed in a cylindrical shape. The fluid replacement port 26 is provided with a detachable closing portion 27 so as to close the opening of the fluid replacement port 26 in an initial state before the infusion set 100 (see FIG. 2) is connected to the fluid replacement port 26. The closing portion 27 is provided integrally with the rehydration port 26 so that it can be screwed off.

As shown in FIG. 2, the infusion set 100 includes, for example, an infusion bag 102, a drip tube 104, an infusion tube 106, a clamp 108, and a connector 110. The infusion bag 102 contains an infusion solution such as physiological saline. The infusion tube 106 connects the drip tube 104 and the connector 110 to each other. The clamp 108 opens and closes the flow path of the infusion tube 106. In the illustrated example, the clamp 108 is a roller clamp. The connector 110 is configured to be connectable to the replacement fluid port 26.

As shown in FIG. 1, in such a blood collection set 10, the first blood collection flow path member 14, the connector main body 16 a and the second blood collection flow path member 18 guide the blood collected from the blood collection needle 12 to the blood collection bag 20. The blood collection line 36 is configured. The second connection port 16c and the branch tube 22 constitute a branch line 38 branched from the blood collection line 36.

The fluid replacement port 26 is provided so that the infusion solution is injected upstream (toward the blood collection needle 12) from a branch portion of the branch line 38 in the blood collection line 36 (connection portion of the second connection port 16c in the connector body 16a). ing. The sealing member 30 constitutes a portion adjacent to the branch portion of the blood collection line 36 on the blood collection bag 20 side.

Next, the operation of the blood collection set 10 configured as described above will be described below. Here, a method will be described in which blood is collected from a donor 200 such as a patient using the blood collection set 10, and then an infusion agent is administered to the donor 200.

First, as shown in FIG. 2, the user prepares a blood collection set 10 (blood collection bag 20), and attaches the infusion set 100 to the blood collection set 10. Specifically, the user twists off the closing portion 27 of the fluid replacement port 26 with respect to the fluid replacement port 26 and connects the connector 110 of the infusion set 100 to the fluid replacement port 26. Then, the user performs priming of the blood collection set 10 and the infusion set 100.

Subsequently, as shown in FIG. 3, the user removes the cap 28 from the blood collection needle 12, opens the clamp 34 and opens the flow path of the branch tube 22, and then collects the blood collection needle 12 into the vein of the donor 200. The needle 12 is punctured.

Then, the initial blood flowing from the blood collection needle 12 into the branch connector 16 via the first blood collection flow path member 14 is stored in the initial blood bag 24 via the branch tube 22. At this time, since the flow path of the second blood collection flow path member 18 is closed by the sealing member 30, the initial blood flow does not flow into the second blood collection flow path member 18. In addition, since the first connection port 16 b of the branch connector 16 is filled with the infusion agent, the initial blood does not flow into the replacement fluid port 26.

When a predetermined amount of initial blood is stored in the initial blood bag 24, the user closes the clamp 34 to close the flow path of the branch tube 22, performs a breaking operation of the sealing member 30, and opens the clamp 32 to perform the second operation. The flow path of the blood collection flow path member 18 is opened.

Then, as shown in FIG. 4, blood flowing from the blood collection needle 12 to the branch connector 16 via the first blood collection flow path member 14 is stored in the blood collection bag 20 via the second blood collection flow path member 18. At this time, since the flow path of the branch tube 22 is closed by the clamp 34, the initial blood flow is not guided from the initial flow blood bag 24 to the second blood collection flow path member 18 via the branch tube 22. Thereby, blood that does not include initial blood that may be contaminated with bacteria existing on the skin and under the skin can be collected in the blood collection bag 20.

When a predetermined amount of blood is stored in the blood collection bag 20, the user closes the clamp 32 to close the flow path of the connection tube 31, and then operates the clamp 108 to open the flow path of the infusion tube 106. .

Then, as shown in FIG. 5, the infusion solution guided from the infusion bag 102 to the infusion tube 106 via the infusion tube 104 is supplied to the replacement fluid port 26, the first connection port 16b, the first blood collection flow path member 14, and the blood collection needle. 12 to the donor 200. At this time, since the infusion agent does not pass through the branch line 38, the blood (initial blood) that has aggregated in the branch line 38 is not returned to the donor 200.

(4) When the administration of the infusion solution is completed, the user removes the blood collection needle 12 from the donor 200 and covers the tip of the blood collection needle 12 with a protector (not shown).

In this case, the blood collection set 10 according to the present embodiment has the following effects.

According to the blood collection set 10, the replacement fluid port 26 is provided on the blood collection needle 12 side of the blood collection line 36 on the blood collection needle 12 side of the branch portion of the branch line 38. The infusion solution can be administered to the donor 200 via the blood collection needle 12 while preventing the solution from returning to the original state.

血 The blood collection line 36 is provided with a branch connector 16 having a connector main body 16a and a first connection port 16b and a second connection port 16c provided in the connector main body 16a. The blood collection line 36 has one end connected to the blood collection needle 12, the first blood collection flow path member 14, the connector main body 16a connected to the other end of the first blood collection flow path member 14, and one end connected to the connector main body 16a. , A second blood collection flow path member 18 having the other end connected to the blood collection bag 20. The fluid replacement port 26 is connected to the first connection port 16b. The branch line 38 has the second connection port 16c and the branch tube 22 connected to the second connection port 16c. The second connection port 16c is located closer to the second blood collection flow path member 18 than the first connection port 16b. According to such a configuration, the configuration of the blood collection set 10 can be simplified.

The blood collection line 36 constitutes a portion adjacent to the branch portion of the blood collection line 36 on the blood collection bag 20 side. The sealing member 30 in which the flow path is closed in the initial state and the flow path is opened by performing a rupture operation is used. Have. According to such a configuration, when the first-flow blood is collected in the first-flow blood bag 24, the first-flow blood is effectively prevented from flowing into the blood collection bag 20 side (the connection tube 31) from the branch portion in the blood collection line 36. be able to.

The branch connector 16 is an integrally molded product. According to such a configuration, the number of components can be reduced as compared with a case where each of the connector main body 16a, the first connection port 16b, and the second connection port 16c is formed as a separate component.

(4) The fluid replacement port 26 is provided with a detachable closing portion 27 so as to close the opening of the fluid replacement port 26 before the blood collection set 10 is used. According to such a configuration, the infusion set 100 is easily connected to the replacement fluid port 26 when the blood collection set 10 is used, while preventing the contamination of the replacement fluid port 26 before the use of the blood collection set 10. be able to.

The blood collection set 10 may include a branch connector 17 shown in FIG. 6 instead of the branch connector 16 described above. As shown in FIG. 6, the branch connector 17 has a connector main body 17a, a first connection port 17b, and a second connection port 17c. The connector main body 17a is formed in a tubular shape, and has a hollow portion for blood flow. The other end of the first blood collection flow path member 14 is connected to one end of the connector main body 17a.

The first connection port 17b is a cylindrical portion that protrudes laterally from one end of the connector main body 17a. The first connection port 17b protrudes from the outer peripheral surface of the connector main body 17a so as to incline toward the direction perpendicular to the axial direction of the connector main body 17a toward the side where the other end of the first blood collection flow path member 14 is located. That is, the angle θ1 between the first connection port 17b and the connector body 17a is set to an acute angle. The angle θ1 to be formed can be appropriately set in consideration of the use situation, manufacturing conditions, and the like. For example, the angle θ1 is set in a range from 30 ° to 60 °, and is set to 45 ° in the present embodiment.

The second connection port 17c is a cylindrical portion protruding laterally from the other end of the connector main body 17a. The second connection port 17c protrudes from the outer peripheral surface of the connector main body 17a so as to incline toward the direction perpendicular to the axial direction of the connector main body 17a toward the side where the other end of the first blood collection flow path member 14 is located. That is, the angle θ2 between the second connection port 17c and the connector main body 17a is set to an acute angle. The angle θ2 to be formed can be appropriately set in consideration of use conditions, manufacturing conditions, and the like. For example, the angle θ2 is set in a range from 30 ° to 60 °, and is set to 45 ° in the present embodiment. The angle θ1 and the angle θ2 are the same. That is, the first connection port 17b and the second connection port 17c extend in parallel with each other. The angle θ1 to be formed and the angle θ2 to be formed do not have to be the same as each other, and can be appropriately changed.

In the present modified example, the first connection port 17b is inclined from the outer peripheral surface of the connector main body 17a toward the direction where the other end of the first blood collection flow path member 14 is located in a direction orthogonal to the axial direction of the connector main body 17a. It protrudes.

According to such a configuration, as compared with the case where the angle θ1 between the connector main body 17a and the first connection port 17b is set to 90 ° (the branch connector 16 shown in FIG. 1), the branch connector 17 is moved in the horizontal direction (the branch connector 16). (A direction orthogonal to the axial direction of the connector main body 17a). Thereby, the branch connector 17 can be formed compact. Further, when performing the operation of removing the blocking portion 27 and the operation of connecting the connector 110 (see FIGS. 2 and 3) of the infusion set 100 to the replacement fluid port 26, the tension applied to the blood collection needle 12 (the blood collection needle 12 is 200).

The second connection port 17c protrudes from the outer peripheral surface of the connector main body 17a so as to incline toward the direction orthogonal to the axial direction of the connector main body 17a toward the side where the other end of the first blood collection flow path member 14 is located. .

According to such a configuration, as compared with the case where the angle θ2 between the connector main body 17a and the second connection port 17c is set to 90 ° (the branch connector 16 shown in FIG. 1), the branch connector 17 is moved in the horizontal direction (the branch connector 16). (A direction orthogonal to the axial direction of the connector main body 17a). Thereby, the branch connector 17 can be formed compact.

The first connection port 17b and the second connection port 17c extend in parallel with each other.

According to such a configuration, the operation of removing the closing portion 27 and the operation of connecting the connector 110 (see FIGS. 2 and 3 and the like) of the infusion set 100 to the replacement fluid port 26 while forming the branch connector 17 compactly. When performing, it can suppress that the branch tube 22 interferes.

The present invention is not limited to the configuration described above. The blood collection set 10, for example, centrifuges blood containing a plurality of components into a plurality of components having different specific gravities (for example, two components of a light specific gravity component and a heavy specific gravity component), and stores each component in a different bag. And may be configured as part of a blood bag system for storage.

血 The blood collection set according to the present invention is not limited to the above-described embodiment, but may adopt various configurations without departing from the gist of the present invention.

Reference Signs List 10 blood collection set 12 blood collection needle 14 first blood collection flow path member 16, 17

branch connector

16a,

17a connector body

16b, 17b

first connection port

16c, 17c second connection port 18 second blood collection flow Path member 20 blood collection bag 22 branch tube 24 initial blood bag 26 fluid replacement port 27 closing part 30 sealing member 31 connection tube 36 blood collection line 38 branch line

Claims

A blood collection needle,
A blood collection bag for containing blood,
A blood collection line that guides blood collected from the blood collection needle to the blood collection bag,
A branch line branched from the blood collection line,
An initial blood bag, which is provided in the branch line and accommodates initial blood at the time of blood collection,
A blood collection set, wherein a blood replacement port for injecting an infusion solution is provided on the blood collection needle side of the blood collection line with respect to a branch portion of the branch line.
The blood collection set according to claim 1,
The blood collection line is provided with a branch connector having a connector body and a first connection port and a second connection port provided in the connector body,
The blood collection line,
A first blood collection flow path member having one end connected to the blood collection needle;
The connector main body connected to the other end of the first blood collection flow path member,
A second blood collection flow path member having one end connected to the connector main body and the other end connected to the blood collection bag,
The fluid replacement port is connected to the first connection port,
The branch line is
Said second connection port;
A branch tube connected to the second connection port,
The blood collection set, wherein the second connection port is located closer to the second blood collection flow path member than the first connection port.
The blood collection set according to claim 1,
The blood collection line constitutes a portion adjacent to the blood collection bag side with respect to the branch portion in the blood collection line, and a sealing member in which the flow path is opened by performing a breaking operation by closing the flow path in an initial state. Have a blood collection set.
The blood collection set according to claim 2, wherein
The blood collection set, wherein the branch connector is an integrally molded product.
The blood collection set according to any one of claims 1 to 4, wherein
A blood collection set, wherein a closing portion is detachably provided in the fluid replacement port so as to close an opening of the fluid replacement port before use of the blood collection set.
The blood collection set according to claim 2 or 4,
The first connection port protrudes from an outer peripheral surface of the connector main body so as to be inclined toward a side where the other end of the first blood collection flow path member is located in a direction orthogonal to an axial direction of the connector main body. Blood collection set.
The blood collection set according to claim 6, wherein
The second connection port protrudes from the outer peripheral surface of the connector main body so as to be inclined toward a side where the other end of the first blood collection flow path member is located in a direction orthogonal to an axial direction of the connector main body. Blood collection set.
The blood collection set according to claim 7, wherein
The blood collection set, wherein the first connection port and the second connection port extend parallel to each other.