WO2023048138A1 - Kit d'extraction et procédé d'extraction - Google Patents

Kit d'extraction et procédé d'extraction Download PDF

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Publication number
WO2023048138A1
WO2023048138A1 PCT/JP2022/034973 JP2022034973W WO2023048138A1 WO 2023048138 A1 WO2023048138 A1 WO 2023048138A1 JP 2022034973 W JP2022034973 W JP 2022034973W WO 2023048138 A1 WO2023048138 A1 WO 2023048138A1
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WO
WIPO (PCT)
Prior art keywords
tube
transfer tube
platelet
sample collection
collection
Prior art date
Application number
PCT/JP2022/034973
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English (en)
Japanese (ja)
Inventor
川口悟司
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2023048138A1 publication Critical patent/WO2023048138A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus

Definitions

  • the present invention relates to a collection kit and collection method for collecting blood products for testing.
  • Blood products include red blood cell products, plasma products, platelet products, and whole blood products. Blood products containing components required by patients are used for blood transfusion. Blood products are stored and transported in medical bags. In order to ensure the safety of blood products, a small sample may be collected and cultured. A culture test detects the presence or absence of pathogens by collecting a sample in a culture bottle and placing the culture bottle in an environment suitable for the growth of bacteria.
  • platelet products are tested according to the following procedure.
  • a small-capacity collection bag is connected to a medical bag containing a platelet preparation (hereinafter referred to as a platelet bag).
  • a portion of the platelet product in the platelet bag is then transferred to the collection bag.
  • the collection bag is then separated from the platelet bag.
  • the collection bag is carried to the clean bench.
  • the platelet product from the collection bag is injected into the blood culture bottle.
  • the tubing of the collection bag Prior to injection, is connected to tubing extending from the sample collection tube. Using the scale of the sample collection tube as a guide, a specified amount of platelet product is transferred from the collection bag to the sample collection tube.
  • the operator operates the valve of the sample collection tube while visually checking the scale of the sample collection tube to transfer a specified amount of platelet product from the sample collection tube to the blood culture bottle.
  • the culture test anaerobic culture and aerobic culture are performed. Therefore, platelet preparations are dispensed into culture bottles used for anaerobic culture and culture bottles used for aerobic culture. After that, the culture bottle is set in a culture apparatus and subjected to a culture test for a predetermined period.
  • US Pat. No. 8,777,921 discloses a collection device for collecting samples from medical bags.
  • the conventional testing procedure requires detachment of the collection bag and sample collection tube in the process of dispensing platelet products from the platelet bag to the culture bottle as described above.
  • An aseptic connecting device for aseptically welding or cutting the tubes is used for the detachment work.
  • Multiple attachment/detachment operations using an aseptic joining apparatus require much labor and waiting time.
  • platelet products remain inside the tube when the tube is welded or cut. Therefore, the conventional examination procedure has the problem that valuable platelet preparations are wasted.
  • the dispensing of the platelet product from the sample collection tube to the culture bottle is performed by the operator's visual observation of the liquid surface and manual work, so the collection amount tends to vary.
  • An object of the present invention is to solve the above problems.
  • a first aspect of the present invention includes a sample collection tube having an upstream end and a downstream end and containing a platelet product; and a platelet bag connected to the upstream end of the sample collection tube.
  • a first transfer tube connected to the downstream end of the sample collection tube;
  • a second transfer tube connected to the downstream end of the sample collection tube;
  • a bottle connecting portion arranged downstream of the tube and downstream of the second transfer tube and to which a culture bottle can be connected;
  • a first sealing member for opening and closing the second transfer tube;
  • a second sealing member for releasably sealing between a second transfer tube and the bottle connection; communicating with the first transfer tube from the downstream end inside the sample collection tube to the upstream; and an overflow tube that protrudes toward the end and causes a predetermined amount of the platelet product to flow out to the first transfer tube.
  • the collection kit described in item (1) above can dispense the platelet product collected in the sample collection tube into two culture bottles by operating the second sealing member and the first sealing member.
  • One of the culture bottles is filled with the amount of platelet preparation that overflows from the overflow tube.
  • the platelet product corresponding to the remaining amount that did not flow out from the overflow tube flows. Therefore, the collection kit allows a predetermined amount of platelet preparation to be weighed into the culture bottle without the need for the user to perform a weighing operation, thereby suppressing variations in the collection amount.
  • the collection kit can introduce the platelet product into the culture bottle by one sterile joining operation of connecting and disconnecting the platelet bag and one sealing operation, so that the labor required for the work can be reduced.
  • the collection kit can reduce the amount of platelet preparation that remains in the tube and is wasted compared to the conventional method.
  • the tip of the overflow tube may be arranged at a position where half the volume of the sample collection tube can be transferred to the first transfer tube.
  • the collection kit described in item (2) above can equalize the amount of platelet products injected into the first culture bottle and the amount of platelet products injected into the second culture bottle.
  • the collection kit of item (3) above can simplify the flow channel configuration.
  • the collection kit of item (4) above can exhaust the air in the internal space from the exhaust valve when injecting platelet products into the sample collection tube.
  • This collection kit can smoothly inject the platelet product into the sample collection tube, shortening the time required for operation.
  • the collection kit of item (5) above can reduce the amount of platelet products remaining in the sample collection tube, and can reduce the loss of precious platelet products.
  • a second aspect of the present invention is a collection method for collecting the platelet product into the culture bottle using the collection kit according to item (1) above, wherein the platelet bag is connected to the connection tube. a step of injecting the platelet product in the platelet bag into the sample collection tube to fill the sample collection tube with the platelet product; separating the platelet bag from the connection tube; connecting the first culture bottle, and opening the second sealing member in a state where the second transfer tube is closed by the first sealing member to pass through the overflow tube to the first culture bottle.
  • a step of injecting a predetermined amount of the platelet product a step of connecting a second culture bottle to the bottle connecting portion; opening the first sealing member to allow the second culture via the second transfer tube; and injecting a predetermined amount of the platelet product into a bottle.
  • the collection method of item (6) above can reduce the labor required for the work.
  • the collection method described above can reduce the amount of platelet preparation that remains in the tube and is wasted compared to the conventional method.
  • the collection method described above can suppress variations in the amount of platelet products collected in culture bottles.
  • the above collection kit and collection method are excellent in work efficiency when collecting platelet products into culture bottles.
  • the collection kit and collection method of the above aspects can reduce waste of platelet preparations.
  • the collection kit and collection method of the above aspects can suppress variations in the amount of platelet preparation collected into the culture bottle.
  • FIG. 1 is a plan view of the collection kit according to the embodiment.
  • 2 is a cross-sectional view of the sample collection tube of FIG. 1;
  • FIG. FIG. 3 is a flow chart showing a collection method using the collection kit according to the embodiment.
  • 4 is a plan view of a platelet bag joined to the collection kit of FIG. 1.
  • FIG. FIG. 5 is a cross-sectional view of the sample collection tube of FIG. 2 in which a platelet product is injected.
  • FIG. 6 is an explanatory diagram showing the dispensing operation of the platelet preparation into the first culture bottle.
  • FIG. 7 is a cross-sectional view of the sample collection tube immediately after the platelet product has been dispensed into the first culture bottle.
  • FIG. 8 is an explanatory diagram showing the dispensing operation of the platelet preparation into the second culture bottle.
  • the collection kit 10 is used, for example, in culture tests for confirming the safety of blood products at establishments such as blood centers that manufacture blood products.
  • culture tests for confirming the safety of blood products at establishments such as blood centers that manufacture blood products.
  • anaerobic bacteria culture and aerobic bacteria culture are tested. Therefore, two culture bottles, one for anaerobic culture and the other for aerobic culture, are used in the culture test.
  • the collection kit 10 is used to collect a liquid sample and dispense a predetermined amount of the sample into two culture bottles.
  • the collection kit 10 includes a sample collection tube 12, a connecting tube 14, an exhaust valve 16, a first transfer tube 18, a second transfer tube 20, a first sealing member 22, and a Y tube. 24 , a third transfer tube 26 , a second sealing member 28 and a bottle connection 30 .
  • the sample collection tube 12 has a cylindrical main body 120 .
  • the body portion 120 has an upstream end portion 121 at one end in the longitudinal direction and a downstream end portion 122 at the other end in the longitudinal direction.
  • the upstream end portion 121 is formed like a wall and seals the upstream side of the body portion 120 .
  • the downstream end portion 122 is formed like a wall and seals the downstream side of the body portion 120 .
  • the sample collection tube 12 has an internal space 123 surrounded by a body portion 120 , an upstream end portion 121 and a downstream end portion 122 .
  • the internal space 123 has a volume that can accommodate the amount of platelet preparation required for injection into two culture bottles 80 (see FIG. 6).
  • the volume of the internal space 123 is, for example, 16 mL.
  • the sample collection tube 12 has a first port 124 and a second port 125 at the upstream end 121 .
  • the first port 124 and the second port 125 have a tubular shape and protrude outward from the upstream end 121 .
  • the first port 124 has a channel 126 communicating with the internal space 123 .
  • the connection tube 14 is connected to the first port 124 .
  • the channel 126 allows the connection tube 14 and the internal space 123 to communicate with each other.
  • connection tube 14 is made of, for example, a flexible thermoplastic resin such as vinyl chloride resin.
  • the connecting tube 14 can be connected to other tubes by using an aseptic connecting device without exposing the internal flow path to the outside air.
  • the exhaust valve 16 is connected to the second port 125 .
  • the exhaust valve 16 is a check valve that allows air to pass through. Exhaust valve 16 allows air to exit from interior space 123 . Exhaust valve 16 blocks the entry of outside air and liquid into interior space 123 .
  • the sample collection tube 12 has a first transfer tube 18 and a third port 127 at its downstream end 122 .
  • the first transfer tube 18 extends straight downstream from the downstream end 122 .
  • the first transfer tube 18 can be made of the same material as the connecting tube 14 . Note that the first transfer tube 18 may be made of a hard material.
  • the first transfer tube 18 is connected in the interior space 123 of the sampling tube 12 to an overflow tube 130 (see FIG. 2).
  • the overflow pipe 130 extends linearly from the downstream end 122 toward the upstream end 121 .
  • Overflow tube 130 communicates with first transfer tube 18 .
  • Overflow tube 130 may be integrally formed with first transfer tube 18 .
  • a tip 131 of the overflow tube 130 is positioned substantially in the center of the main body 120 in the longitudinal direction.
  • the overflow tube 130 collects platelets accumulated above the tip 131 .
  • the formulation can be expelled.
  • the space above the tip 131 of the overflow tube 130 is called an upper space 132
  • the space below the tip 131 is called a lower space 133 .
  • the upper space 132 and the lower space 133 each have a capacity (eg, 8 mL) that is half the total capacity of the internal space 123 .
  • the third port 127 extends cylindrically downstream from the downstream end 122 .
  • the third port 127 has a channel 134 communicating with the internal space 123 .
  • Channel 134 opens into downstream end 122 .
  • Downstream end 122 has a sloped portion 135 that slopes toward the opening of channel 134 .
  • the sloped portion 135 is sloped so that the opening of the channel 134 is at the lowest position at the downstream end 122 .
  • the inclined portion 135 allows the platelet product to flow to the third port 127 without causing the platelet product to stay at the bottom of the internal space 123 .
  • the second transfer tube 20 is connected to the third port 127 as shown in FIG.
  • the second transfer tube 20 is constructed of the same material as the connecting tube 14 .
  • the second transfer tube 20 is bent and connected to a downstream Y-tube 24 .
  • a first sealing member 22 is attached to the second transfer tube 20 .
  • the first sealing member 22 consists of a clamp that can close the second transfer tube 20 . In the initial state, the first sealing member 22 opens the second transfer tube 20 .
  • the Y-tube 24 connects the downstream of the first transfer tube 18, the downstream of the second transfer tube 20, and the third transfer tube 26.
  • a Y-tube 24 joins the first transfer tube 18 and the second transfer tube 20 .
  • a third transfer tube 26 is connected to the downstream branch of the Y-tube 24 .
  • the third transfer tube 26 is constructed of the same material as the connecting tube 14 .
  • a second sealing member 28 is connected downstream of the third transfer tube 26 .
  • the second sealing member 28 is a cylindrical member having a channel inside.
  • the second sealing member 28 further has a breakable sealing member in the channel.
  • the channel inside the second sealing member 28 connects the third transfer tube 26 on the upstream side and the bottle connecting portion 30 on the downstream side.
  • the sealing member seals the flow path inside the second sealing member 28 to prevent communication of the flow path.
  • the internal sealing member breaks.
  • the sealing member is broken, the flow path inside the second sealing member 28 is opened.
  • the second sealing member 28 allows communication between the third transfer tube 26 and the bottle connecting portion 30 by opening the internal flow path.
  • the bottle connecting portion 30 has an outer cylinder 301, an injection needle 302, and a cap 303.
  • the outer tube 301 is a cylindrical member having dimensions capable of accommodating the mouth portion 82 of the culture bottle 80 (see FIG. 6).
  • the injection needle 302 projects short from the center of the bottle connector 30 .
  • the injection needle 302 has a lumen that communicates with the flow path of the second sealing member 28 .
  • the injection needle 302 penetrates the stopper 84 of the culture bottle 80 .
  • the injection needle 302 can inject the platelet product into the culture bottle 80 .
  • Cap 303 is connected to outer cylinder 301 via a hinge. In the initial state, the cap 303 closes the outer cylinder 301 to keep the injection needle 302 clean.
  • the bottle connector 30 is not limited to the configuration described above, and for example, a blood collection needle with a cap can be used.
  • the collection kit 10 of this embodiment is configured as described above, and the operation thereof will be described below along with the method of use.
  • the platelet preparation dispensing work using the collection kit 10 is performed according to the procedure shown in FIG. First, the operator joins the platelet bag 90 to the collection kit 10 (step S10).
  • the platelet bag 90 is a medical bag containing a platelet product, as shown in FIG. Platelet bag 90 has tubing 92 for connection.
  • the tube 92 and the connection tube 14 are joined by an aseptic joining device without coming into contact with the outside air.
  • the operator injects the platelet product into the sample collection tube 12 (step S20 in FIG. 3).
  • the collection kit 10 and the platelet bag 90 are arranged with the platelet bag 90 facing up and the bottle connector 30 facing down.
  • the first sealing member 22 of the collection kit 10 is opened, and the second sealing member 28 is kept closed (initial state).
  • the platelet product flows from the platelet bag 90 into the collection kit 10 by gravity.
  • Platelet preparations are stored in the sample collection tube 12 , first transfer tube 18 , second transfer tube 20 and third transfer tube 26 .
  • the exhaust valve 16 causes the air inside the collection kit 10 to flow out. By removing the air inside the collection kit 10, the platelet preparation can be smoothly injected into the collection kit 10.
  • the user closes the connection tube 14 at the timing when the liquid surface of the platelet product reaches the tip of the sample collection tube 12 . This stops the infusion of the platelet product. Thereafter, the user uses a tube sealer (high-frequency sealer) or the like to seal the connection tube 14, and then separates the platelet bag 90 (step S30 in FIG. 3).
  • the tube sealer separates the connecting tube 14 and the tube 92 of the platelet bag 90 and seals the ends by welding. Separation of the connecting tube 14 and the tube 92 is performed without exposing the internal flow path to the outside air.
  • the user attaches the first culture bottle 80 to the bottle connector 30 (step S40 in FIG. 3).
  • the user opens cap 303 of bottle connector 30 .
  • the user pierces the mouth portion 82 of the culture bottle 80 into the outer cylinder 301 with the injection needle 302 .
  • the first culture bottle 80 is connected to the bottle connector 30 as shown in FIG.
  • the user closes the first sealing member 22 as shown in step S50 of FIG. Thereafter, as shown in step S60 of FIG. 3, the user opens the second sealing member .
  • the user bends the second sealing member 28 to break the internal sealing member.
  • the platelet product in the sample collection tube 12 flows through the overflow tube 130 from the sample collection tube 12 toward the culture bottle 80 .
  • the platelet product in the upper space 132 above the tip 131 of the overflow tube 130 flows into the culture bottle 80 .
  • the platelet product stops flowing out of the sample collection tube 12.
  • a predetermined amount eg, 8 mL
  • the collection kit 10 can measure a predetermined amount of platelet product into the culture bottle 80 without requiring a user's weighing operation.
  • the user removes the first culture bottle 80 from the bottle connector 30 and connects the second culture bottle 80 to the bottle connector 30 (step S70 in FIG. 3).
  • the user opens the first sealing member 22 (step S80 in FIG. 3).
  • the platelet preparation flows through the second transfer tube 20 and the third transfer tube 26 and is injected into the culture bottle 80 .
  • a predetermined amount eg, 8 mL
  • the user removes the second culture bottle 80 from the bottle connector 30 (step S90 in FIG. 3).
  • Dispensing of the platelet preparation using the collection kit 10 is completed by the above steps.
  • the collection kit 10 two culture bottles 80 into which a predetermined amount of platelet preparation is injected are obtained.
  • One of the two culture bottles 80 is subjected to an anaerobic culture test and the other is subjected to an aerobic culture test.
  • the present invention is not limited to the above-described embodiments, and can take various configurations without departing from the gist of the present invention.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un kit d'extraction (10) qui comprend : un tube d'extraction d'échantillon (12) ; un premier tube de transfert (18) qui est relié à une extrémité aval (122) du tube d'extraction d'échantillon (12) ; un second tube de transfert (20) qui est relié à l'extrémité aval (122) du tube d'extraction d'échantillon (12) ; et une section de raccordement de bouteille (30) à laquelle une bouteille de culture (80) peut être reliée. Le tube d'extraction d'échantillon (12) comporte un tube de trop-plein (130) qui se raccorde au premier tube de transfert (18), fait saillie vers une extrémité amont (121) depuis l'extrémité aval (122) à l'intérieur du tube d'extraction d'échantillon (12), et amène une quantité prescrite d'une préparation de plaquettes à s'écouler vers le premier tube de transfert (18).
PCT/JP2022/034973 2021-09-27 2022-09-20 Kit d'extraction et procédé d'extraction WO2023048138A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2021-156348 2021-09-27
JP2021156348 2021-09-27

Publications (1)

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WO2023048138A1 true WO2023048138A1 (fr) 2023-03-30

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999062614A1 (fr) * 1998-06-01 1999-12-09 Baxter International Inc. Systemes pour prelevements sanguins et methodes faisant appel a un tube de prelevement sanguin a evacuation d'air
WO2013137361A1 (fr) * 2012-03-14 2013-09-19 テルモ株式会社 Récipient pour analyse de sang et instrument de prélèvement sanguin

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999062614A1 (fr) * 1998-06-01 1999-12-09 Baxter International Inc. Systemes pour prelevements sanguins et methodes faisant appel a un tube de prelevement sanguin a evacuation d'air
WO2013137361A1 (fr) * 2012-03-14 2013-09-19 テルモ株式会社 Récipient pour analyse de sang et instrument de prélèvement sanguin

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