JP2014217555A - Transfusion tube set and method of use thereof - Google Patents

Abstract

PROBLEM TO BE SOLVED: To effectively reduce a risk of exposure of a dangerous medicine such as an anticancer agent.SOLUTION: A transfusion tube set 1 includes: a tube assembly 2 adapted for infusion administration of a dangerous medicine to a patient; a package 3 for storing the tube assembly 2 in a sterile condition; and a bag 5 removably attached to the package that has an openable/closable zipper 22 at the opening. The bag is adapted so that it stores at least the used tube assembly after the administration of the dangerous medicine, and is disposed of in a state that the zipper is closed. Since the tube assembly to which the dangerous medicine adheres can be disposed of as it is in a state that it is tightly sealed in the bag, the risk of exposure of the dangerous medicine can be effectively reduced.

Description

  The present invention relates to an infusion tube set and a method for using the infusion tube, and more particularly to an infusion tube set used for infusion administration of a dangerous drug such as an anticancer drug to a patient and a method for using the infusion tube set.

  Anticancer drugs or anticancer drugs that are typically known as dangerous drugs have cytotoxicity (genotoxicity such as mutagenicity, carcinogenicity, teratogenicity, sperm toxicity, etc.) and cancer cells Not only does it work on normal cells as well. Normal cells are less susceptible to cytotoxic effects than cancer cells and have a higher ability to repair injuries. There is a difference in the effect of anticancer drugs between normal cells and cancer cells, and this difference establishes anticancer drug treatment.

  On the other hand, anticancer drugs have a merit of therapeutic effect and a risk of adverse effects for cancer patients, but there is only a risk for persons other than cancer patients, particularly medical workers. For these people, chronic effects can occur by taking very small amounts of drugs for long periods of time. This problem is similar to the asbestos problem.

  Therefore, in medical facilities such as hospitals, it is urgent to take measures against occupational exposure or exposure to anticancer drugs. The routes of exposure to anticancer agents are mainly the route by skin contact that directly touches the anticancer agent or touches the object contaminated with the anticancer agent, the route by inhalation that inhales contaminated air, and gum. There are routes by digestion and absorption by actions such as chewing, smoking and eating and drinking with exposed hands. To prevent exposure to anticancer drugs as much as possible, provide education and information to healthcare professionals and people working in medical facilities (healthcare professionals, etc.), and have them take adequate exposure measures on an individual basis. Of course, it is important, but besides that, it is important to prevent the anticancer drug from leaking to the external environment as much as possible.

Special table 2009-543608 gazette

  When an anticancer drug is administered by infusion to a patient, the anticancer drug is likely to leak into the external environment during the preparation and administration of the anticancer drug. Therefore, it is necessary to prevent leakage of anticancer drugs at both stages. It is necessary to take measures when transporting the prepared anticancer agent from the preparation site to the administration site because the anticancer agent may be attached to the outer surface of the device during preparation of the anticancer agent. is there. In addition, since anti-cancer drugs are attached to instruments that have been used after administration of anti-cancer drugs, the instruments can be safely used without exposing the anti-cancer drugs attached to these instruments. It is necessary to take measures so that it can be discarded.

  Accordingly, an object of the present invention is to solve at least one of the above problems. More specifically, the present invention aims to effectively reduce the risk of exposure to hazardous chemicals.

According to one aspect of the invention,
A tube assembly adapted for infusion administration of a hazardous drug to a patient, the tube and a proximal adapter provided at the proximal end of the tube for connection to an infusion container or drug supply side; A tube assembly having a distal end connector provided at a distal end portion of the tube and connected to a patient side connector;
A package containing the tube assembly in a sterile condition;
A bag having a zipper that is detachably attached to the package and that can be opened and closed at an opening portion, containing the tube assembly that has been used at least after the administration of the dangerous drug at the administration site, and the zipper A bag adapted to be disposed of in a closed state;
An infusion tube set is provided.

  Preferably, a pocket is provided on an outer surface portion or an inner surface portion of the package, and the bag is accommodated in the pocket so as to be removable.

  Preferably, the bag has an engaging portion that engages with the outside for temporary storage of the bag.

  Preferably, the engaging portion includes a hole formed between the zipper and an opening edge of the bag.

  Preferably, the bag is formed so as to be impermeable to the hazardous chemical.

  Preferably, the bag has such a thickness that the dangerous chemical is impermeable.

  Preferably, the bag has a thickness of 0.06 mm or more.

  Preferably, the bag has a warning label.

  Preferably, the tip connector is a Fashial ™ connector.

  Preferably, the proximal adapter includes a spike for puncturing the infusion container and a proximal connector for connecting the distal connector, and the proximal connector is a Fashial (trademark) connector. .

  Preferably, the bag accommodates the tube assembly in which the proximal adapter is connected to the infusion container containing the dangerous medicine prepared at a preparation site before administration of the dangerous medicine together with the infusion container. And adapted to be transported from the preparation site to the administration site with the zipper closed.

  Preferably, the tube assembly includes an intermediate connector between the proximal adapter and the distal connector, and the intermediate connector is a Faseal ™ connector, and the Faseal ™ connector of another infusion tube set It is connectable with the tip connector consisting of.

According to another aspect of the present invention, there is a method of using the infusion tube set,
Transporting the infusion tube set to the hazardous drug preparation site;
At the preparation site, the package is opened, the tube assembly is taken out, the proximal adapter is connected to the infusion container containing the prepared dangerous chemical, and the tube assembly and the infusion container are connected to each other. Storing in the bag in a state, and closing the zipper;
Transporting the bag containing the tube assembly and the infusion container from the preparation location to the hazardous drug administration location;
Opening the zipper at the administration site to remove the tube assembly and the infusion container and connecting the distal connector to the patient connector;
Storing the tube assembly and the infusion container that have been used after the end of the administration of the hazardous drug at the administration site, and closing the zipper;
Transporting and discarding the bag containing the tube assembly and the infusion container from the administration site to a disposal site;
A method of using the infusion tube set is provided.

According to still another aspect of the present invention, a method of using the infusion tube set comprises:
Preparing the infusion tube set;
Preparing another infusion tube set, wherein the another infusion tube set comprises:
Another tube assembly adapted for infusion administration of hazardous drugs to a patient, on another tube and another infusion container or another medicinal solution supply side provided at the proximal end of the other tube Another tube assembly having another proximal adapter to be connected and another distal connector provided at the distal end of the other tube and connected to another patient-side connector;
Another package containing the other tube assembly in a sterile condition;
Comprising the steps of:
Transporting the infusion tube set to the hazardous drug preparation site;
Transporting the bag containing the tube assembly of the infusion tube set and the infusion container containing the prepared dangerous drug in a state of being connected to each other from the preparation place to the dangerous drug administration place And steps to
Conveying the separate infusion tube set to the administration site;
At the administration site, the other package of the other infusion tube set is opened and the other tube assembly is removed, and the other proximal adapter is connected to the other infusion container containing a secondary drug, Setting another tip connector on the patient side;
At the administration site, the zipper of the bag of the infusion tube set is opened to take out the tube assembly and the infusion container, and the tip connector thereof is connected to the other infusion tube set that has been transported in advance. Connecting to said another intermediate connector of the tube assembly;
The tube assembly and the infusion container of the infusion tube set that have been used after the administration of the dangerous drug at the administration site, and the other tube assembly and the another infusion container of the another infusion tube set In the bag and closing the zipper;
Transporting and discarding the bag from the administration site to a disposal site;
A method of using the infusion tube set is provided.

According to yet another aspect of the invention,
A bag adapted to contain and transport and dispose of instruments with hazardous chemicals, and has a zipper that can be opened and closed at the opening, and is thick enough to impede hazardous chemicals A bag is provided.

  ADVANTAGE OF THE INVENTION According to this invention, the outstanding effect that the risk of exposure to a dangerous chemical can be reduced effectively is exhibited.

It is a perspective view of the infusion tube set concerning the embodiment of the present invention. It is II-II sectional drawing of the infusion tube set of FIG. It is a front view of a 1st tube assembly. It is a front view of the 2nd tube assembly. It is a front view of a bag. FIG. 6 is a perspective view showing a male Fashial ™ connector. 1 is a perspective view showing a female Fashial ™ connector. FIG. It is a perspective view for demonstrating the action | operation of a face seal (trademark) connector. It is a perspective view for demonstrating the action | operation of a face seal (trademark) connector. It is a perspective view for demonstrating the action | operation of a face seal (trademark) connector. It is a figure which shows the conveyance route of an infusion tube set. It is a perspective view for demonstrating the usage method of the infusion tube set in a preparation place, and shows the process of introducing the anticancer agent in a vial into a syringe. It is a front view for demonstrating the usage method of the infusion tube set in a preparation place, and shows the process of introducing the anticancer agent in a syringe into an infusion bag. It is a front view for demonstrating the usage method of the infusion tube set in a preparation place, and shows a priming process. It is a front view which shows the bag and its contents when it is conveyed from a preparation place to an administration place. It is a perspective view for demonstrating the usage method of the infusion tube set in an administration place, and shows the mode at the time of anticancer agent administration. It is a front view which shows the bag and its contents when it is conveyed from an administration place to a disposal place. It is a perspective view for demonstrating the alternative Example of the usage method of an infusion tube set, and shows the mode at the time of anticancer agent administration. FIG. 7 is a front view showing a bag and its contents when transported from a dosing site to a disposal site in an alternative embodiment. It is a perspective view which shows the modification of an infusion tube set. It is a front view which shows the modification of a bag. It is a front view of the 1st modification of the 1st tube assembly. It is a perspective view of an access port. It is sectional drawing of an access port. It is a front view of the 2nd modification of the 1st tube assembly. It is a front view of the 1st modification of the 2nd tube assembly. It is a front view of the 2nd modification of the 2nd tube assembly. It is a front view of the 3rd modification of the 2nd tube assembly. It is a front view of a 3rd tube assembly.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. Note that the terms “upper”, “lower”, “left”, “right”, “front”, “rear”, “vertical” and “horizontal” used below are arranged in the illustrated example for easy understanding. It should be noted that it is used in a limited manner and does not necessarily mean the direction as it is used in actual usage.

The “dangerous drug” to be used in the present invention means “Hazardous Drug” in English. That is, the dangerous chemical means a chemical corresponding to one or more of the following six characteristics (1) to (6) in humans or animals. Dangerous drugs include drugs used in cancer chemotherapy (including anticancer drugs), antiviral drugs, hormone drugs, molecular targeted drugs, and monoclonal antibodies.
(1) Carcinogenicity (2) Teratogenicity or other developmental toxicity (3) Genital toxicity (4) Organ toxicity at low doses (5) Genotoxicity (6) Dangerous by the above criteria Of chemical structure and toxicity of new drugs similar to

Using or working with hazardous drugs (hazard drugs) in a medical setting may cause skin rashes, infertility, miscarriages, congenital abnormalities, and possibly leukemia and other cancers There is. NIOSH (National Institute of Occupational Safety and Health), ASHP (American Medical Pharmacists Association (formerly American Hospital Pharmacists Association)), ISOPP (International Society of Cancer Chemotherapy Pharmacists) and ONS (Cancer Nursing Association) Recommended in the guidelines issued by organizations. References are as follows.
(1) Preventing Occupational Exposure to Antineoplastic Other Hazardous Drugs in Health Care Settings National Institute for Occupational Safety and Health. DHHS (NIOSH) Publication No. 2004-165, 2004
(2) ASHP Reports: ASHP Guidelines on Handling Hazardous Drugs. Am J Health Syst Pharm. 63: 1172-1191, 2006
(3) ISOPP Standards of Practices: Safe Handling of Cytotoxics. J Oncol Pharm Pract, 13 (Suppl): 1-81, 2007
(4) Oncology Nursing Society: Safe Handling of Hazardous Drugs (Second Ed.) ONS, 1-85,2011

  Below, embodiment using the anticancer agent which is the representative example as a dangerous chemical | drug | medicine is described. However, it should be noted that the dangerous chemicals to which the present invention can be applied are not limited to anticancer agents, and the present invention can be applied to dangerous chemicals other than anticancer agents.

  1 and 2 show an infusion tube set 1 according to this embodiment. An infusion tube set 1 includes a tube assembly 2 adapted for administration of an infusion of an anticancer drug to a patient, a package or a package 3 that accommodates the tube assembly 2 in a sterile state, and is detachably attached to the package 3. A bag or a bag 5. In particular, the pocket 4 is provided on the outer surface portion of the package 3, and the bag 5 is accommodated in the pocket 4 so as to be removable.

  The tube assembly 2 is accommodated in the package 3 in an appropriately folded state. The package 3 is made of a transparent and flexible horizontally-long rectangular plastic bag. The outer peripheral edge is completely sealed, and the inside is filled with a sterilizing gas such as ethylene oxide gas. Accommodate.

  The pocket 4 is formed by attaching a plastic sheet 7 to one outer surface (front surface or rear surface) 6 of the package 3 having a rectangular shape. A space between the package outer surface 6 and the sheet 7 becomes a pocket 4. In the case of the present embodiment, as shown in the drawing, sheets 7 having a lateral width equal to the package outer surface 6 and a small height are pasted along both side edges 6A and 6B and lower edge 6C of the package outer surface 6. As a whole, a horizontally elongated rectangular and upward pocket 4 is formed in a substantially lower half of the package outer surface 6.

  The bag 5 has a lateral width that is equal to or slightly smaller than the inner width of the pocket 4, and is accommodated by being inserted into the pocket 4 from above in a folded state in the vertical direction. Details of the bag 5 will be described later. The bag 5 can be easily taken out by grasping the bag 5 and pulling it out of the pocket 4.

  The tube assembly 2 is roughly divided into two types, a first tube assembly 2A as shown in FIG. 3 and a second tube assembly 2B as shown in FIG. In any case, the infusion tube set 1 can be configured by being accommodated in the package 3. First, the first tube assembly 2A will be described.

  As shown in FIG. 3, the first tube assembly 2 </ b> A includes a tube 11, a proximal adapter 12 </ b> A that is provided at the proximal end of the tube 11 and is connected to an infusion container (not shown) or a chemical solution supply side. A distal end connector 13A provided at the distal end of the tube 11 and connected to a patient side connector (not shown). When infusion is performed, the chemical solution from the infusion container or from the chemical solution supply side flows from the proximal adapter 12A through the tube 11 toward the distal connector 13B. Therefore, the proximal end side of the tube 11 can be paraphrased as the upstream side, and the distal end side of the tube 11 can be restated as the downstream side. In the present embodiment, a drug solution containing an anticancer drug is administered to a patient by infusion. However, the drug solution may be administered by a method other than infusion, for example, by pumping. This embodiment is applicable to any administration method.

  As is well known, the tube 11 is formed of a material such as soft polyvinyl chloride (DEHP free), polybutadiene (PVC free), styrene elastomer (PVC free) or the like, and has flexibility (flexibility). The proximal adapter 12A is made of plastic or the like, and has a bottle needle or spike 14 (covered with a protective cap 14p in the figure) for puncturing a rubber stopper of an infusion bag as an infusion container, and priming described later. It sometimes has a proximal connector 15 for connecting the distal connector 13A. The distal connector 13A and the proximal connector 15 will be described in detail later. A protective cap (not shown) is detachably attached to the tip connector 13A. Further, a well-known drip tube 16 and a roller clamp 17 are provided at a position between the proximal adapter 12 </ b> A and the distal connector 13 </ b> A in the tube 11. The drip tube 16 and the roller clamp 17 are provided at a position close to the proximal adapter 12A.

  The proximal end adapter 12 </ b> A, the distal end connector 13 </ b> A, the drip tube 16, and the roller clamp 17 are fixed to the tube 11 so that they cannot be removed from the tube 11. Thereby, the exposure risk of the anticancer agent produced by removing any member from the tube 11 can be reduced or eliminated.

  Next, the second tube assembly 2B shown in FIG. 4 will be described focusing on the differences from the first tube assembly 2A.

  The second tube assembly 2B also includes a tube 11, a proximal adapter 12B, a distal connector 13B (the distal end is covered with a protective cap 13Bp in the drawing), an infusion tube 16, and a roller clamp 17.

  However, unlike the proximal adapter 12A, the proximal adapter 12B has only the spike 14 and does not have the proximal connector 15. The tip connector 13B is also different from the tip connector 13A, which will be described in detail later.

  In addition, an intermediate connector 18 is provided at a position of the tube 11 between the roller clamp 17 and the tip connector 13B. The intermediate connector 18 is fixed to a three-way cock 19 provided in the middle of the tube 11. The three-way cock 19 is configured to switch the connection state of the flow path on the upstream side (base end side), downstream side (tip end side), and intermediate connector side. The switching position includes a first position connecting the upstream and downstream flow paths, a second position connecting the downstream and intermediate connector flow paths, and a flow path between the upstream, downstream, and intermediate connector sides. There are four positions: a third position for connecting all of the above and a fourth position for connecting the flow paths on the upstream side and the intermediate connector side.

  The intermediate connector 18 is configured to be connected to the distal end connector 13A of the first tube assembly 2A. In this case, the intermediate connector 18 forms a patient side connector. This will also be described in detail later.

  Next, the bag 5 will be described with reference to FIG. The bag 5 has a vertically long rectangular shape as a whole, and an opening 21 is formed at the upper end, and an openable / closable chuck, fastener or zipper 22 is provided in the opening 21. The zipper 22 is provided at a position below the upper end edge 23 as an opening edge of the bag 5 by a predetermined distance, and extends along the entire width of the bag 5. The bag 5 is transparent so that its contents can be recognized at a glance. The bag 5 is made of a flexible plastic, and the zipper 22 is also made of a flexible plastic and is integrally provided on the inner surface of the bag 5. As the zipper 22, for example, a slide type zipper known under the name of Ziplock (registered trademark) can be suitably used. When the zipper 22 is opened, access to the bag 5 is possible. When the zipper 22 is closed, access to the bag 5 is not possible, and at the same time, the bag 5 is sealed, and the gas and liquid in the bag 5 are sealed. Leakage is prevented. The bag 5 is folded into four equal parts in the vertical direction along a plurality of folding lines L1, L2, L3 as shown in the figure, and is accommodated in the pocket 4.

  As will be described in detail later, the bag 5 accommodates at least the used tube assembly 2 after the administration of the anticancer drug at the administration site, and is adapted to be discarded with the zipper 22 closed. ing. Therefore, the bag 5 is formed so that not only the liquid anticancer agent but also the anticancer agent which has evaporated to become a gas is impermeable. As a result, exposure of the anticancer agent attached to the contents of the bag 5 to the outside can be suppressed. More specifically, the bag 5 has such a thickness as to make the anticancer agent impermeable, and preferably has a thickness of 0.06 mm or more.

  As will be described in detail later, the bag 5 is adapted to be temporarily stored during administration of the anticancer drug at the administration site (usually it takes about 3 to 4 hours). For this reason, the bag 5 has an engaging part that engages with the outside for temporary storage. Specifically, the engaging portion includes a hole 25 formed in a tab 24 between the zipper 22 and the bag upper end edge 23. In order to maintain the sealed state of the bag 5 when the zipper 22 is closed, the hole 25 is provided outside the zipper 22, that is, at a position that does not affect the sealing performance of the bag 5. In the present embodiment, the hole 25 is provided at one end in the width direction of the tab 24, but the position of the hole 25 is arbitrary. Moreover, although the hole 25 is circular in this embodiment, the shape of the hole 25 is also arbitrary.

  The bag 5 has a warning label 26 on its outer surface, specifically, at least one of the front surface and the rear surface. In the present embodiment, a warning label 26 is printed so as to stand out on the front surface 27 of the bag 5. The warning label 26 indicates that the contents of the bag 5 contain an anticancer drug or a dangerous drug so that all persons working in the medical facility and medical facilities (medical workers, etc.) can recognize at a glance. Has been. Thereby, handling of the bag 5 containing the contents becomes more careful, and it is possible to promote countermeasures against exposure of the anticancer agent.

  The warning label 26 is preferably provided in the upper half of the bag 5 or as high as possible, as shown in the illustrated example. As a result, it is possible to prevent the contents accumulated in the bag 5 from being hidden by the warning label 26 so as to be difficult to see, and to handle the bag 5 containing the contents more safely.

  In addition, the description matter of the warning label 26 is arbitrary, for example, you may describe so that the zipper 22 must be closed except when the bag is opened. The installation position of the warning label 26 is also arbitrary. The warning label 26 is not necessarily printed, and may be a seal, a sticker, or the like.

  Next, the distal connector 13A and the proximal connector 15 of the first tube assembly 2A and the intermediate connector 18 of the second tube assembly 2B will be described.

  As is well known, the term “connector” in the present application includes a pair of connectors that are configured according to the same standard and can be connected to each other, that is, both a male connector and a female connector. Such a connector is anti-cancer both when it is not connected to the mating connector (when it is free), when connecting the connectors, and when disconnecting (disconnecting) the connectors. It is preferable to adopt a structure that does not cause leakage, spillage, jumping, transpiration, etc. of the chemical solution containing the agent. Therefore, the connector of this embodiment also has such a structure. As a connector having such a structure, a connector having a valve that can be opened only at the time of connection can be adopted. However, in this embodiment, a PhaSeal (trademark) connector that exhibits extremely excellent performance with respect to prevention of such liquid leakage is adopted. Has been.

  This Faseal ™ connector is already known and manufactured and sold by the present applicant (see http://www.bdj.co.jp/ms/products/phaseal.html). When using the Faseal (TM) connector, exposure during drug preparation and administration is significantly reduced compared to using conventional connectors, and there are currently several reports on this fact (eg Susan Spivey, Thomas HC. Determining Sources of Workplace Contamination: Conventional Preparation vs Closed System. Hospital Pharmacy Vol 38, Feb 2003 pp.137-139). Therefore, it is possible to construct a closed system infusion system (CSTD) by adopting the Fashial ™ connector, and to minimize the risk of exposure to anticancer drugs. is there. At the same time, contaminants can be prevented from entering the system.

  With reference to FIGS. 6 to 10, the Fashial ™ connector will be described. The connector includes a first or male connector 30 and a second or female connector 50 that can be connected to each other.

  FIG. 6 shows the male connector 30. (A) shows the whole connector in a normal state before use or in an extended position, and (b) and (c) are views for showing the internal structure by omitting or cutting part of parts for convenience. (B) is the figure which abbreviate | omitted the sleeve 33, (c) is the figure which cut | disconnected the piston 34 on the way.

  The male connector 30 is supported by the injection needle storage cylinder 31, the cylinder 32, the sleeve 33, the piston 34, the connection plug 35, the piston sealing 36 fixed to the tip of the piston 34, and the injection needle storage cylinder 31. And an injection needle 37 accommodated in the piston 34. The cylinder 32 is rotatable around the central axis C with respect to the injection needle storage cylinder 31. The sleeve 33 and the piston 34 can move in the direction of the central axis C with respect to the cylinder 32, and can rotate about the central axis C with respect to the cylinder 32. The sleeve 33 and the piston 34 cannot move in the direction of the central axis C with respect to each other, but can rotate around the central axis C. The connection plug 35 is a film body or membrane made of an elastomer or the like, and hermetically and liquid-tightly seals the tip of the flow path in the connector. The injection needle 37 is a hollow needle made of stainless steel or the like, and has a channel inside. A connecting portion 38 for connecting to a counterpart member (tube or the like) is formed at the proximal end of the injection needle storage cylinder 31.

  The sleeve 33 includes a pair of elastically deformable semicircular arms 39 and a sleeve claw 40 formed at the tip of the arm 39. The pair of sleeve claws 40 are engaged with a pair of sleeve claw holes 41 formed in the piston sealing 36. The piston sealing 36 is formed with a pair of piston claws 42 adjacent to the distal end side of the sleeve claw hole 41, and the piston claws 42 are inserted into a pair of piston claw grooves 43 formed in the sleeve 33 with a 90 ° difference. Is possible. A pair of guide protrusions 44 is formed on the sleeve 33, and the guide protrusions 44 can be inserted into guide grooves 45 formed in the cylinder 32 with a difference of 90 °.

  FIG. 7 shows the female connector 50. The female connector 50 is formed in a bottomed cylindrical shape that receives the piston 34 and the piston sealing 36 of the male connector 30. The female connector 50 includes a pair of insertion grooves 51 for inserting the piston claw 42 and the sleeve claw 40 of the male connector 30 and a pair for guiding the piston claw 42 so as to selectively rotate only the piston claw 42 in the inserted state. The guide slot 52 and the connection plug 53 for being brought into butt contact with the connection plug 35 of the male connector 30 are provided. Similarly to the connection plug 35 of the male connector 30, the connection plug 53 is a film body made of an elastomer or the like, and hermetically and liquid-tightly seals the end of the flow path in the connector. A connecting portion is also formed at the proximal end of the female connector 50.

  The operation of these connectors will be described. When connecting both connectors, as shown in FIG. 8, the piston 32 and the sleeve claw 40 are inserted into the insertion groove 51 of the female connector 50 by holding the cylinder 32 of the male connector 30, and the male connector 30 is connected to the female connector 30. Push toward 50. Then, the arm 39 is deformed to the proximal end, and the engagement between the sleeve claw 40 and the sleeve claw hole 41 is released, and at the same time, only the piston claw 42 gets over the wall 54 on the distal end side of the guide slot 52 and Enter the entrance.

  While maintaining this pushed-in state, the cylinder 32 is rotated as shown in FIG. That is, the cylinder 32 is rotated as if twisted. Simultaneously with this rotation, the guide groove 45 rotates toward the guide protrusion 44. Piston 34 and piston sealing 36 rotate with cylinder 32. The cylinder 32 is rotated until the piston pawl 42 reaches the end of the guide slot 52. Once the cylinder 32 is rotated, the piston pawl 42 is hooked on the wall 54, so that even if the cylinder 32 is released, the male connector 30 does not come off from the female connector 50, and the connection plugs 35, 53 of both connectors. Keeps in close contact.

  When the piston claw 42 reaches the end of the guide slot 52 (the state shown in FIG. 8), the guide groove 45 also coincides with the guide protrusion 44. As a result, the injection needle storage cylinder 31 and the cylinder 32 can move relative to the sleeve 33 and the piston 34 in the axial direction.

  Therefore, as shown in FIG. 10, the cylinder 32 is pushed toward the female connector 50, and the cylinder 32 is slid to the axial front end side on the outer peripheral side of the sleeve 33. As a result, the sleeve 33 and the piston 34 are stored in the cylinder 33, and the male connector 30 moves to the contracted position.

  Then, the injection needle 37 inside the male connector 30 reaches the inside of the female connector 50 by sequentially piercing the connection plug 35 of the male connector 30 and the connection plug 53 of the female connector 50 that are in close contact with each other. As a result, the inside of the male connector 30 and the inside of the female connector 50 are brought into communication. This communication state is achieved only by the internal passage of the injection needle 37. In other words, there is no place where the fluid flows other than the internal passage of the injection needle 37. The connection plugs 35 and 53 are brought into close contact with the outer peripheral surface of the injection needle 37 to completely seal the gap therebetween. Thereby, a safe connector connection is achieved.

  To remove both connectors, the procedure reverse to the above may be performed. As can be seen from the above description, the chemical solution does not jump, spill, or leak out when both connectors are connected, connected, and disconnected. Even when the connector is filled with a medicine and is free, the surfaces of the connection plugs 35 and 53 are dry, and the chemical solution in the connector does not leak or evaporate. Therefore, by using the Fashial ™ connector, a completely closed infusion system can be constructed, and the risk of exposure to anticancer agents can be minimized.

  In the present embodiment, the male connector 30 is used for the distal connector 13A of the first tube assembly 2A, the female connector 50 is used for the proximal connector 15, and the female connector 50 is used for the intermediate connector 18 of the second tube assembly 2B. Is used. However, it will be appreciated that the male and female connector arrangements may be reversed. The same applies to other parts not shown here. As the male connector 30, “BD Faseal Injector Lurelock” (manufacturing and sales notification number 07B1X00003000132) manufactured by Nippon Becton Dickinson Co., Ltd. can be suitably used. As the female connector 50, for example, a connector portion of “BD Face seal protector” (manufacturing / sales notification number 07B1X00003000129) manufactured by Nippon Becton Dickinson Co., Ltd. can be suitably used. For example, US Patent Application Publication No. 2011 / 0125128A1 can be cited as a reference patent document of the Faseal (trademark) connector.

  Next, the usage method of the infusion tube set 1 which concerns on this embodiment is demonstrated. In the basic embodiment described below, an infusion tube set 1 having a first tube assembly 2A as shown in FIG. 3 is used. For convenience, the infusion tube set including the first tube assembly 2A is referred to as a first infusion tube set 1A.

  For convenience, the infusion tube set including the second tube assembly 2B as shown in FIG. 4 is referred to as a second infusion tube set 1B. In an alternative embodiment described later, an infusion tube set in which the pocket 4 and the bag 5 are omitted from the second infusion tube set 1B is used. For convenience, this infusion tube set is referred to as a second infusion tube set 1B 'without a bag.

  In FIG. 11, the conveyance route or path | route of the infusion tube set 1 is shown. After the infusion tube set 1 is delivered to the medical facility, it is first transported to the preparation place P1 (Route I). The preparation place P1 refers to a place where an anticancer agent is prepared, typically a preparation section or preparation room in a medical facility, more specifically a desk, bench or cabinet where the preparation is actually performed. Say. Here, the pharmacist wears disposable gowns, gloves, masks, caps, etc., and prepares them with sufficient exposure measures.

  After the preparation, the bag 5 in which the tube assembly 2 and the like are accommodated and the zipper 22 is closed is conveyed from the preparation place P1 to the administration place P2 (Route II). This conveyance is performed, for example, by a staff member or a nurse in the medical facility. In particular, it should be noted that this transport may be performed by a person who has not taken any exposure measures. However, since all the instruments to which the anticancer agent is attached are sealed in the bag 5, it is safe. Leakage of the anticancer agent from the bag 5 during transportation is reliably prevented.

  The administration location P2 refers to a location where an anticancer drug is administered to a patient, typically a hospital room or treatment room in a medical facility, more specifically a location where administration is actually performed adjacent to the patient. Say. Here, nurses wear disposable gowns, gloves, masks, caps, etc., and perform administration work with sufficient exposure measures.

  After the administration is completed, the bag 5 in which the tube assembly 2 and the like are accommodated and the zipper 22 is closed is transported from the administration location P2 to the disposal location P3 and discarded (Route III). This transport discard is performed immediately after the end of administration by a nurse who has taken measures against exposure, and the clothes worn at the same time as the disposal of the bag 5 are also discarded. However, it may be transported by a staff member who has not taken exposure measures, and in this case as well, all the instruments to which the anticancer agent adheres are sealed in the bag 5, which is safe. Leakage of the anticancer agent from the bag 5 during transportation is reliably prevented.

  The disposal place P3 refers to a place where the bags 5 containing the instruments are discarded. Typically, a disposal container dedicated to medical waste installed in a medical facility, preferably dedicated to hazardous chemical waste. A waste container. The disposal place P3 may be in the same room as the administration place P2, or in another room. In addition, it can also be called the disposal place P3 including the place where the waste is actually disposed in the medical facility to the place outside the medical facility where the waste is finally disposed of by incineration or the like. In this case, a trader who does not take countermeasures for exposure is often transported from the medical facility to a disposal site outside the medical facility. However, it is safe because leakage of the anticancer drug from the bag 5 is prevented including such a transport process.

  On the other hand, after the second infusion tube set 1B including the second tube assembly 2B is delivered to the medical facility, it may be directly transported to the administration site P2 (Route IV). This will be described later.

  Next, the specific usage method of the infusion tube set 1 in each place is demonstrated.

  In the preparation place P1, the bag 5 is taken out from the pocket 4 of the first infusion tube set 1A. Then, the package 3 is opened, and the first tube assembly 2A is taken out. The package 3 is discarded here.

  On the other hand, as shown in FIG. 12, an infusion container containing a small bottle or vial 61 containing an anticancer agent, a syringe 62, and a liquid in which the anticancer agent is mixed (referred to as a mixed solution). As an infusion bag 63 (see FIG. 13). A syringe connector 64 similar to the distal end connector 13A of the first tube assembly 2A (consisting of the male Faseal ™ connector 30) is attached to the distal end portion of the syringe 62. A vial adapter 65 is attached to the mouth of the vial 61. The vial adapter 65 includes a vial connector 66 similar to the proximal connector 15 (consisting of a female Faseal ™ connector 50) of the first tube assembly 2A at the distal end thereof. As the vial adapter 65, “BD Face seal protector” (manufacturing and sales notification number 07B1X00003000129) manufactured by Nippon Becton Dickinson Co., Ltd. is preferably used. By using this, pressure inside and outside the vial (positive pressure and negative pressure) can be made equal, and when the rubber stopper of the vial 61 is punctured, it is possible to prevent the drug aerosol or gas from leaking outside.

  As is well known, the vial adapter 65 has a hollow needle or spike for piercing a stopper (rubber stopper) at the mouth of the vial 61 at the base end thereof. The vial adapter 65 is attached to the vial 61 in a state where a stopper is punctured with a spike. Next, the syringe connector 64 of the syringe 62 in the contracted state is connected to the vial connector 66 of the vial adapter 65.

  The plunger 67 of the syringe 62 is pulled while the whole is turned upside down (the vial 61 is up and the syringe 62 is down), and the anticancer agent in the vial 61 is inhaled into the syringe 62. Thereafter, the syringe connector 64 is removed from the vial connector 66 and the syringe 62 is removed from the vial adapter 65. Since the syringe connector 64 and the vial connector 66 are made of Fashial (trademark) connectors, the anticancer drug can be prevented from jumping or leaking at the time of removal. The vial 61 and the vial adapter 65 are discarded here.

  Next, as shown in FIG. 13, the proximal adapter 12A of the first tube assembly 2A is connected to an infusion bag 63 in which a physiological saline solution to be mixed is previously stored. At this time, the spike 14 of the proximal adapter 12A is punctured into the rubber stopper 68 of the infusion bag 63. The syringe connector 64 of the syringe 62 is connected to the proximal connector 15 of the proximal adapter 12A.

  A first passage extending from the distal end portion of the spike 14 to the attachment port of the tube 11 and a second passage extending from the distal end portion of the spike 14 into the proximal connector 15 are formed inside the proximal end adapter 12A. Therefore, when the plunger 67 of the syringe 62 is pushed, the anticancer agent in the syringe 62 is introduced into the infusion bag 63 through the second passage. This introduction is indicated by arrows in the figure. Thereby, an anticancer agent is mixed with physiological saline, and an anticancer agent is prepared. The prepared anticancer agent is also referred to as a post-preparation anticancer agent. When the anticancer agent has been introduced, the syringe connector 64 is removed from the proximal connector 15 and the syringe 62 is removed from the proximal adapter 12A. The syringe 62 including the syringe connector 64 is now discarded.

  Since the air is filled in the tube 11 as it is, priming is performed to expel this air and replace it with the anticancer agent after preparation. During this priming, the distal connector 13A of the first tube assembly 2A is connected to the proximal connector 15 as shown in FIG. Then, the drip tube 16 is repeatedly crushed and elastically restored to its original shape (that is, contracted and expanded). As a result of the pumping action, the anticancer drug after preparation in the infusion bag 63 gradually enters the tube 11, and the air in the tube 11 is gradually pushed out into the infusion bag 63, and finally in the tube 11. After the preparation, the air is exchanged with the anticancer agent, and the inside of the tube 11 is almost filled with the anticancer agent after the preparation. The flow of the anticancer agent after preparation at this time is indicated by an arrow in the figure.

  Thus, according to the present embodiment, it is possible to perform loop priming in which the distal connector 13A is connected to the proximal connector 15 and the anticancer drug is circulated after preparation from the beginning. On the other hand, in the case of a normal tube assembly that does not have a Faseal (TM) connector, the order of priming to fill the tube with physiological saline and then introducing the anticancer drug into the infusion bag must be followed. . In the case of this embodiment, there is no restriction | limiting in the order of anticancer agent introduction | transduction and priming, and it is possible to perform the latter after the former. Therefore, according to the present embodiment, the preparation operation can be performed with an operation easier than usual.

  When priming is thus completed, the distal connector 13A is removed from the proximal connector 15. And as shown in FIG. 15, in the state in which the infusion bag 63 was connected to the 1st tube assembly 2A, both are accommodated in the bag 5. FIG. Thereafter, the zipper 22 is closed and both are sealed in the bag 5, and in this state, the bag 5 is conveyed to the administration site P2. Thus, since both containing the anticancer agent are transported to the administration site P2 in a state of being sealed in the bag 5, the risk of exposure to the anticancer agent during transport can be minimized. The distal end connector 13A may be sealed in the bag 5 while being connected to the proximal end connector 15 and transported.

  Next, at the administration place P2, the zipper 22 of the bag 5 is opened, and the first tube assembly 2A and the infusion bag 63 are taken out from the bag 5. Then, as shown in FIG. 16, the infusion bag 63 is hooked on the hook 72 of the drip stand 71, and the tip connector 13A is temporarily placed at an appropriate position. At the same time, the hole 25 of the bag 5 that has been emptied is hooked on another hook 73 (or the same hook 72) of the drip stand 71, and the bag 5 is temporarily stored. Thereby, the bag 5 can be temporarily stored immediately without worrying about the place where the bag 5 is placed. During the temporary storage of the bag 5, the zipper 22 is preferably closed. It is also preferable that the warning label 26 has a notice to that effect.

  The patient side catheter set 75 is then attached to the patient 74 using known techniques. As is well known, the patient-side catheter set 75 includes a vein indwelling needle inserted into the vein of the patient 74, a tube connected thereto, and the like. In particular, at the proximal end of the patient-side catheter set 75, a patient-side proximal connector 76 as a patient-side connector including a female Faseal (trademark) connector 50 is provided. The distal connector 13A is connected to the patient-side proximal connector 76, and drip administration of the anticancer drug is started.

  When the administration of the anticancer drug is completed, the distal connector 13A is removed from the patient proximal connector 76, and the used first tube assembly 2A and the infusion bag 63 are again shown in FIG. It is accommodated in the bag 5 in a connected state. At this time, the patient side catheter set 75 may be removed from the patient 74 and housed in the bag 5 together. Further, gloves or the like worn by the nurse may be accommodated in the bag 5 together. In this way, the bag 5 has a sufficiently large capacity so that it can cope with an increase in contents. Thereafter, the zipper 22 is closed and the contents are sealed in the bag 5. Thereafter, the bag 5 is transported to the disposal place P3, and the bag 5 is discarded without taking out the contents as it is. As described above, the content containing the anticancer agent is transported to the disposal site P3 in a state of being sealed in the bag 5 and discarded, so that the risk of exposure to the anticancer agent during and after transport is minimized. Can be stopped.

  The above is the method of using the basic embodiment, but the method of using the alternative embodiment will be described below.

  The first infusion tube set 1A provided with the first tube assembly 2A is transported to the preparation place P1, and after the preparation of the anticancer agent, the infusion bag 63 and the first tube assembly 2A are accommodated in the bag 5 and administered. The point conveyed to the place P2 is the same as in the basic embodiment.

  On the other hand, the second infusion tube set 2B 'without a bag is directly conveyed to the administration site P2. The route IV in FIG. 11 corresponds to this. The second tube assembly 2B is taken out from the package 3 of the second infusion tube set 2B 'without the bag, and is used for administration of the secondary drug not containing the anticancer drug.

  That is, administration of an anticancer drug may cause side effects such as vomiting. Therefore, in order to suppress this side effect, an auxiliary drug such as an antiemetic agent is administered in advance. Since the secondary drug does not contain an anticancer drug, the distal connector 13B of the second tube assembly 2B is a normal connector that is not a Fashial (trademark) connector, specifically, a male luer lock connector. . Such luer lock connectors comply with the international standard (ISO) for luer connectors.

  Referring to FIG. 18, at the administration site P <b> 2, the proximal adapter 12 </ b> B of the second tube assembly 2 </ b> B is connected to the secondary drug infusion bag 81 that stores the secondary drug, and the distal connector 13 </ b> B is connected to the patient side catheter set 82. It is connected to the patient side proximal connector 83 (that is, the distal connector 13B is set on the patient side). The patient-side proximal connector 83 is also composed of a normal connector, typically a luer lock connector. Then, the drip administration of the secondary drug is started.

  On the other hand, after the start of the administration of the secondary drug, the first tube assembly 2A transported from the preparation place P1 is connected or coupled to the second tube assembly 2B, and the anticancer drug is administered. An anticancer drug may be administered concurrently during the administration of the secondary drug, or the anticancer drug may be administered after the administration of the secondary drug is completed.

  At this time, the distal end connector 13A of the first tube assembly 2A is connected to the intermediate connector 18 of the second tube assembly 2B including the female Faseal (trademark) connector 50. In this manner, when viewed from the distal end connector 13A, the counterpart intermediate connector 18 corresponds to the patient-side connector.

  When the administration of the secondary drug and anticancer drug is completed, the drug left in the vicinity of the distal end connector 13B of the second tube assembly 2B is used in another syringe, physiological saline, or the like as usual if necessary. Then, it is pushed into the vein of the patient 74, and the line is washed. Then, after an appropriate backflow measure is applied to the patient side catheter set 82, the distal end connector 13B of the second tube assembly 2B is detached from the patient side proximal end connector 83 of the patient side catheter set 82.

  Next, as shown in FIG. 19, the second tube assembly 2B to which the secondary drug infusion bag 81 is connected and the first tube assembly 2A to which the infusion bag 63 is connected remain connected to each other or to each other. In the separated state, it is accommodated in the bag 5. At this time, the patient-side catheter set 75, gloves, and the like may be housed together in the bag 5 as described above. Thereafter, the zipper 22 is closed and the contents are sealed in the bag 5. The bag 5 is transported to the disposal place P3, and the bag 5 is discarded without taking out the contents as it is.

  By the way, since there is no bag 5 in the second infusion tube set 2B ′ without a bag that has been transported to the administration place P2, during administration of the anticancer agent, a bag is provided at the administration place P2 as shown in FIG. There will be only one 5. However, the bag 5 is sufficient to accommodate at least the second tube assembly 2B to which the secondary drug infusion bag 81 is connected and the first tube assembly 2A to which the infusion bag 63 is connected while being connected to each other. There is a capacity. Therefore, these can be accommodated together, transported and discarded as they are.

  As a modification of this alternative embodiment, it is conceivable to directly transport the second infusion tube set 1B with a bag to the administration site P2 instead of the second infusion tube set 1B 'without a bag. In this case, as indicated by the phantom line in FIG. 18, during the administration of the anticancer agent, the two bags 5 are temporarily stored at the administration location P2. In this case, both tube assemblies 2A, 2B, etc. may be accommodated together in one bag 5 after administration, or each tube assembly 2A, 2B, etc. is accommodated in separate bags 5 after disconnecting each other. May be.

  Thus, according to this embodiment, since the infusion tube set 1 in which the bag 5 is attached to the package 3 is provided, not only can the instrument with the anticancer agent attached be accommodated in the bag 5 and discarded as it is. The instrument can be accommodated in the bag 5 and transported. That is, the bag 5 can be used not only for disposal but also for transportation. Therefore, it is possible to minimize the risk of exposure to anticancer drugs not only after disposal but also during transportation, and ensure the safety of medical workers and the like. Moreover, since the infusion tube set 1 is equipped with the bag 5 from the beginning, and the bag 5 always exists near the tube assembly 2 at the preparation place P1 and the administration place P2, the tube assembly 2 to be transported to the next place, etc. Can be stored in the bag 5 immediately and without forgetting, and can greatly contribute to measures against exposure to anticancer agents.

  Further, since the bag 5 is removably accommodated in the pocket 4 on the outer surface portion of the package 3, the bag 5 can be reliably attached to the package 3 until the package 3 is opened. Can be prevented from falling off or being lost.

  Moreover, since the bag 5 has an engaging part that engages with the outside for temporary storage, the bag 5 can be easily stored temporarily during administration of a chemical solution, and is practical. In particular, when the engaging portion includes the hole 25, the bag 5 can be temporarily stored by hooking the hole 25 on the hook 72 of the drip stand 71 typically provided at the administration site P2, which is very convenient. . Moreover, since the hole 5 is only opened in the bag 5, manufacture is also easy.

  Further, the bag 5 is formed so as to make the anticancer agent impermeable, and preferably has a thickness that makes the anticancer agent impermeable, preferably 0.06 mm or more. Since it has thickness, it can suppress reliably that the anticancer agent in the bag 5 permeate | transmits the bag 5, and leaks outside, and can reduce the risk of anticancer agent exposure reliably.

  Moreover, since the bag 5 has the warning label 26, it is possible to call attention to medical staff and the like, and it is possible to further promote the anticancer drug exposure countermeasure.

  In addition, since each connector (13A, 15, 18) to be connected and disconnected is a Fashial (trademark) connector, when the connector is connected, during connection and disconnection, and when the connector is free, It is possible to prevent the chemical solution containing the anticancer drug from jumping, spilling or leaking. This can minimize the risk of exposure to anticancer drugs.

  Moreover, according to the usage method of the infusion tube set 1 which concerns on this embodiment, it is possible to safely convey and discard instruments, such as the tube assembly 2 to which the anticancer agent adhered. Moreover, since the bag 5 which concerns on this embodiment exhibits the outstanding effect as mentioned above, it can be grasped | ascertained also as independent invention.

  The preferred embodiments of the present invention have been described in detail above, but various other embodiments of the present invention are possible. For example, the following embodiments are possible.

  (1) The method of attaching the bag to the package does not necessarily have to be a method of storing in a pocket. For example, there are a method of winding and pressing with a belt or the like, a method of temporarily bonding, a method of storing a bag in a package, and the like. If the bag is also contained in the package, the bag is also maintained in a sterile state. The package may be provided with a closed bag storage bag that provides a space isolated from the space in which the tube assembly is placed, either integrally or separately, and the bag may be stored in the bag storage bag. In this case, since only the space in which the tube assembly is inserted is sterilized and the bag containing bag does not need to be sterilized, the cost required for the sterilization can be reduced. Moreover, when accommodating a bag in a pocket like this embodiment, the method of inserting and accommodating the bag 5 from the side with the pocket 4 facing sideways as shown in FIG. 20 can be considered. At this time, if the depth direction or insertion direction of the pocket 4 and the extension direction of the zipper 22 are made to coincide with each other as shown in the figure, the bending of the bag 5 at the time of insertion can be suppressed and the insertion can be further facilitated. .

  Further, when the bag is accommodated in the pocket, it is possible to provide a retaining means for preventing the bag from coming off. For example, it is possible to provide a flap that covers the opening of a pocket containing the bag, a belt that spans the opening, or an adhesive or double-sided tape that temporarily holds the bag in the pocket.

  Moreover, when accommodating a bag in a pocket, you may provide a pocket in the inner surface part of a package, and accommodate a bag in this.

  The size, shape, number, etc. of the pockets are arbitrary. For example, a pocket having substantially the same size as the package may be formed. Further, the bottom of the pocket may be removed as long as the bag does not fall out. A plurality of bags may be accommodated in the pocket. A bag may be accommodated in each of the plurality of pockets.

  (2) The size, shape, number, etc. of the bag are arbitrary. As shown in FIG. 21, the bag 5 may have a plurality of zippers 22. There are two examples shown, whereby a double seal of the bag is achieved. By providing the plurality of zippers 22, the airtightness of the bag 5 is improved, and the risk of exposure to the anticancer drug can be further reduced.

  The engagement portion in the bag may include a belt, a hook, a pinch, a magnet, an adhesive tape, and the like. When the engaging portion includes a hole, the bag 5 may have a plurality of holes 25 as shown in FIG. In the illustrated example, there are a total of three on both side portions and the central portion, thereby increasing the number of holes for hooking the bag 5 and improving convenience.

  The size, shape, color, etc. of the warning label in the bag are also arbitrary.

  (3) A tube assembly other than the structure described above can be used. The drip tube and the roller clamp may not necessarily be provided, and other parts and instruments may be provided. It may be like an extension tube connected between the tubes. The configurations of the proximal adapter and the distal connector are also arbitrary. The distal connector (and the patient connector), the proximal connector, and the intermediate connector are not necessarily face seal connectors.

  The intermediate connector 18 may be provided in the first tube assembly 2A. Further, the proximal connector 15 may be provided in the second tube assembly 2B. Two or more of the intermediate connector 18 and the proximal connector 15 may be provided in one tube assembly 2. A plurality of tube assemblies 2 may be connected to one tube assembly 2, or another tube assembly 2 may be connected to the tube assembly 2 connected to one tube assembly 2.

  Examples of modifications of the tube assembly include the following. The first and second tube assemblies 2A and 2B shown in FIGS. 3 and 4 are used as basic examples. In the following description, description of the same components is omitted, and only the same reference numerals are given in the drawings.

  (3a) FIG. 22 shows a first modification of the first tube assembly, which is indicated by 2A ′ as a whole. This first modification differs from the basic embodiment in that an access port 101 is provided in the middle of the tube 11. Specifically, a three-way cock 19 is attached in the middle of the tube 11, and an access port 101 is attached to the empty port. The three-way cock 19 and the access port 101 are provided in the tube 11 at a position between the drip tube 16 and the proximal adapter 12A. A protective cap (not shown) is attached to the spike 14 and the tip connector 13A. The proximal end adapter 12A is provided with a flexible band 121, and the band 121 is provided with a plurality of holes 122. As described above, the infusion bag 63 connected to the proximal adapter 12 </ b> A is hooked on the hook 72 of the drip stand 71 and supported by being suspended. In this state, the hook 72 of the drip stand 71 is inserted into any hole 122 of the band 121, and the spike 14 is prevented from coming off the infusion bag 63. In other words, the hook 72 of the drip stand 71 is inserted into the hole 122 at a position that can prevent the spike 14 from coming off.

  23 and 24 show the access port 101. FIG. The access port 101 includes a port main body 102 and a film body 103 fixed to the port main body 102. A male luer lock connector 104 to be attached to the three-way cock 19 is provided at the base end of the port main body 102, and the film body 103 is provided at the distal end of the port main body 102. The film body 103 is made of a material such as silicon, is elastically deformable, and includes a slit 105 that can be opened. The film body 103 is normally in a closed state in which the slit 105 is closed as shown in FIG. 24A. However, when an external access device 106 such as a syringe or an infusion set is inserted into the slit 105, FIG. As shown in b), the slit 105 is opened. As a result, access from the access device 106 to the access port 101 and thus to the first tube assembly 2A 'is possible. Further, the tip 101A of the access port 101 to which the access device 106 is connected constitutes a female luer connector and can be connected to either a luer slip or luer lock connector according to the international standard (ISO) of the luer connector. ing. As a result, the access device 106 having a normal luer connector can be directly connected, and a dedicated access device is not required, thereby improving convenience.

  Such an access port 101 is already known and is available from the Applicant under the product name “BD Q Site ™ Luer Access Split Septum” or “BD Q Site ™ Closed Luer Access Site”. (See http://www.bdj.co.jp/ms/products/qyte.html). The access port 101 is a kind of a closed system. A closed instrument refers to an instrument used to prevent external contaminants from entering the system.

  According to this first modification, it is possible to additionally supply another liquid or medicine into the first tube assembly 2 </ b> A ′ through the access port 101.

  In particular, according to the first modification, the anticancer agent remaining in the first tube assembly 2A ′ immediately before the end of administration of the anticancer agent is transferred to the patient's vein using the access device 106 and the access port 101. Can be fed into. That is, when the anticancer agent in the infusion bag connected to the first tube assembly 2A ′ disappears, the infusion bag is crushed under negative pressure, and the anticancer remaining in the first tube assembly 2A ′. The drug can no longer be supplied to the patient. As a result, the planned amount of anticancer drug cannot be supplied to the patient, which is problematic in terms of appropriate treatment.

  Therefore, in such a case, for example, a syringe as the access device 106 is filled with a flush solution such as physiological saline, the syringe is inserted into the access port 101, and the flush solution is supplied from the syringe into the first tube assembly 2A '. Then, the anticancer drug left in the first tube assembly 2A 'can be supplied into the patient's vein by the flush solution. Since the anticancer agent remaining in the first tube assembly 2A ′ is discharged from the first tube assembly 2A ′ as if it was washed, the access port 101 is a flush (washing) port. In other words. Thus, since the anticancer agent remaining in the first tube assembly 2A ′ can be supplied to the patient, a predetermined amount of the anticancer agent is supplied to the patient to optimize treatment. It is possible.

  From this point of view, it is preferable to provide the access port 101 on the base end side or upstream side as much as possible. This is to reduce the amount of anticancer agent that is not supplied to the patient and eventually remains in the first tube assembly 2A 'as much as possible. The access port 101 can also be provided on the proximal adapter 12A.

  (3b) FIG. 25 shows a second modified example of the first tube assembly, which is indicated by 2A ″ as a whole. This second modified example does not have the drip tube 16 and the roller clamp 17, and the tube 11 It differs from the basic embodiment in that a one-touch clamp or a clamp 111 is attached on the way, and the clamp 111 is for opening and closing a passage in the tube 11 as is well known.

  At the time of priming in the second modified example, the distal end connector 13A is connected to the proximal end connector 15. Since there is no drip tube 16, the pump action by pushing back cannot be expected. However, natural priming by the action of gravity is possible simply by connecting the distal connector 13A to the proximal connector 15. That is, the air in the tube 11 positioned below the infusion bag 63 floats through the first passage and the second passage inside the proximal adapter 12A and enters the infusion bag 63, and after the preparation in the infusion bag 63 Replaced with anticancer drugs.

  (3c) FIG. 26 shows a first modification of the second tube assembly, and the whole is shown by 2B ′. The difference of the first modification from the basic embodiment is that the position of the three-way cock 19 to which the intermediate connector 18 is attached has been changed to a position upstream of the drip tube 16, and the roller clamp 17 The three-way cock 19 to which the access port 101 is attached is added at a position between the distal end connectors 13B. A protective cap (not shown) is attached to the spike 14 and the tip connector 13B.

  As already mentioned, by providing the access port 101, it is possible to additionally supply other liquid or medicine from the access device having a normal connector through the access port 101 into the second tube assembly 2B ′. It is.

  Further, regarding the alternative embodiment of the above method of use, since the position of the intermediate connector 18 comprising the Fashial ™ connector has been moved to the upstream side of the drip tube 16, the first tube assembly 2A ″ shown in FIG. When combined with the second modification, the drip tube 16 and the roller clamp 17 are shared, and the flow rate of the anticancer agent sent from the first tube assembly 2A ″ can be adjusted.

  That is, when the tip connector 13A of the first tube assembly 2A ″ is connected to the intermediate connector 18 of the second tube assembly 2B ′ to supply the anticancer agent, the anticancer agent is upstream of the drip tube 16. The flow rate of the mixed drug is adjusted by the drip tube 16 and the roller clamp 17, and as a result, the flow rate of the anticancer drug is decreased by the drip tube 16 and the roller clamp 17. Adjusted by.

  Thus, the drip tube 16 and the roller clamp 17 can be shared by setting the intermediate connector 18 at the upstream side of the drip tube 16. Even when the drip tube 16 and the first tube assembly without the roller clamp 17 such as the first tube assembly 2A ″ of the second modification are used in combination, the drip tube 16 of the second tube assembly 2B ′ is used. Further, the flow rate of the anticancer agent can be adjusted by using the roller clamp 17 and the cost of the entire system can be reduced.

  (3d) FIG. 27 shows a second modification of the second tube assembly, which is indicated by 2B ″ as a whole. This second modification is a first modification of the second tube assembly shown in FIG. The filter 112 and the clamp 111 are added to the filter 112 and the clamp 111. The filter 112 and the clamp 111 are provided between the roller clamp 17 and the three-way stopcock 19 with the access port 101.

  (3e) FIG. 28 shows a third modification of the second tube assembly, which is generally indicated by 2B ″ ′. This third modification is a basic embodiment of the second tube assembly shown in FIG. The three-way cock 19 with the access port 101 is added to the three-way cock 19 with the access port 101 adjacent to the three-way cock 19 with the intermediate connector 18, and the three-way cock 19 with the intermediate connector 18 and the tip connector 13B. The three-way stopcock 19 with the access port 101 and the three-way stopcock 19 with the intermediate connector 18 may be interchanged.

  (3f) FIG. 29 shows a third tube assembly, which is another type of tube assembly, and the entirety is indicated by 2C. The third tube assembly 2C forms an extension tube. That is, the first tube assemblies 2A, 2A ′, 2A ″ are connected in series to the normal tube assembly so that the first tube assemblies 2A, 2A ′, 2A ″ can be connected to the normal tube assembly that does not have the Fashial ™ connector. It is.

  The third tube assembly 2 </ b> C includes a tube 11, a proximal connector 15 </ b> C provided at the proximal end of the tube 11, and a distal connector 13 </ b> C provided at the distal end of the tube 11. The third tube assembly 2C includes a three-way cock 19 with an intermediate connector 18 and a three-way cock 19 with an access port 101, which are provided between the proximal connector 15C and the distal connector 13C. In the illustrated example, the three-way cock 19 with the intermediate connector 18 is provided on the proximal end side with respect to the three-way cock 19 with the access port 101, but these arrangements may be interchanged. The intermediate connector 18 is a female Fashial (trademark) connector, the proximal connector 15C is an ordinary female luer lock connector, and the distal connector 13C is an ordinary male luer lock connector. A protective cap (not shown) is attached to the proximal connector 15C and the distal connector 13C.

  In use, the proximal connector 15C of the third tube assembly 2C is connected to a distal connector (male luer lock connector) of a normal tube assembly. Further, the tip connector 13C of the third tube assembly 2C is connected to a counterpart connector (female luer lock connector) to which the tip connector of a normal tube assembly is to be originally connected. As a result, the normal tube assembly is extended by the third tube assembly 2C. Since the intermediate connector 18 is provided in the third tube assembly 2C, the tip connector 13A of the first tube assemblies 2A, 2A ′, 2A ″ can be connected thereto.

  The embodiment of the present invention is not limited to the above-described embodiment, and includes all modifications, applications, and equivalents included in the concept of the present invention defined by the claims. Therefore, the present invention should not be construed as being limited, and can be applied to any other technique belonging to the scope of the idea of the present invention. The various configurations or members described in the above embodiments can be combined in different ways as much as possible.

DESCRIPTION OF SYMBOLS 1 Infusion tube set 1A 1st infusion tube set 1B 2nd infusion tube set 1B '2nd infusion tube set 2 without bag 2 Tube assembly 2A, 2A', 2A "1st tube assembly 2B, 2B ', 2B ", 2B"'2nd tube assembly 2C 3rd tube assembly 3 Package 4 Pocket 5 Bag 11 Tube 12A, 12B Base end adapter 13A, 13B, 13C End connector 14 Spike 15, 15C Base end connector 18 Intermediate connector 22 Zipper 23 Upper edge 24 Tab 25 Hole 26 Warning label 30 Male connector 50 Female connector 63 Infusion bag 74 Patient 75 Patient side catheter set 76 Patient side proximal connector 81 Secondary drug infusion bag 82 Patient side catheter set 83 Patient side proximal connector 101 Access Po Door P1 prepared location P2 administration location P3 disposal location

Claims (15)

A tube assembly adapted for infusion administration of a hazardous drug to a patient, the tube and a proximal adapter provided at the proximal end of the tube for connection to an infusion container or drug supply side; A tube assembly having a distal end connector provided at a distal end portion of the tube and connected to a patient side connector;
A package containing the tube assembly in a sterile condition;
A bag having a zipper that is detachably attached to the package and that can be opened and closed at an opening portion, containing the tube assembly that has been used at least after the administration of the dangerous drug at the administration site, and the zipper A bag adapted to be disposed of in a closed state;
An infusion tube set characterized by comprising: The infusion tube set according to claim 1, wherein a pocket is provided on an outer surface portion or an inner surface portion of the package, and the bag is accommodated in the pocket so as to be removable. The infusion tube set according to claim 1 or 2, wherein the bag has an engaging portion that engages with the outside for temporary storage of the bag. The infusion tube set according to claim 3, wherein the engagement portion includes a hole formed between the zipper and an opening edge of the bag. The infusion tube set according to any one of claims 1 to 4, wherein the bag is formed so as to be impermeable to the dangerous chemical. The infusion tube set according to any one of claims 1 to 5, wherein the bag has a thickness that does not allow the dangerous chemical to pass therethrough. The infusion tube set according to any one of claims 1 to 6, wherein the bag has a thickness of 0.06 mm or more. The infusion tube set according to any one of claims 1 to 7, wherein the bag has a warning label. The infusion tube set according to any one of claims 1 to 8, wherein the tip connector is a Fashial (trademark) connector. The proximal adapter has a spike for puncturing the infusion container and a proximal connector for connecting the distal connector, and the proximal connector is a Fashial (trademark) connector. The infusion tube set according to claim 9. The bag contains, together with the infusion container, the tube assembly in which the proximal adapter is connected to the infusion container containing the dangerous medicine prepared at a preparation site before administration of the dangerous medicine; and The infusion tube set according to any one of claims 1 to 10, wherein the infusion tube set is adapted to be transported from the preparation site to the administration site with the zipper closed. The tube assembly includes an intermediate connector between the proximal adapter and the distal connector, the intermediate connector comprising a Fashial (trademark) connector, and the second infusion tube set comprising a Fashial (trademark) connector. It is connectable with a front-end | tip connector. The infusion tube set as described in any one of Claims 1-11 characterized by the above-mentioned. It is the usage method of the infusion tube set as described in any one of Claims 1-12,
Transporting the infusion tube set to the hazardous drug preparation site;
At the preparation site, the package is opened, the tube assembly is taken out, the proximal adapter is connected to the infusion container containing the prepared dangerous chemical, and the tube assembly and the infusion container are connected to each other. Storing in the bag in a state, and closing the zipper;
Transporting the bag containing the tube assembly and the infusion container from the preparation location to the hazardous drug administration location;
Opening the zipper at the administration site to remove the tube assembly and the infusion container and connecting the distal connector to the patient connector;
Storing the tube assembly and the infusion container that have been used after the end of the administration of the hazardous drug at the administration site, and closing the zipper;
Transporting and discarding the bag containing the tube assembly and the infusion container from the administration site to a disposal site;
A method of using an infusion tube set, comprising: It is the usage method of the infusion tube set as described in any one of Claims 1-12,
Preparing the infusion tube set;
Preparing another infusion tube set, wherein the another infusion tube set comprises:
Another tube assembly adapted for infusion administration of hazardous drugs to a patient, on another tube and another infusion container or another medicinal solution supply side provided at the proximal end of the other tube Another tube assembly having another proximal adapter to be connected and another distal connector provided at the distal end of the other tube and connected to another patient-side connector;
Another package containing the other tube assembly in a sterile condition;
Comprising the steps of:
Transporting the infusion tube set to the hazardous drug preparation site;
Transporting the bag containing the tube assembly of the infusion tube set and the infusion container containing the prepared dangerous drug in a state of being connected to each other from the preparation place to the dangerous drug administration place And steps to
Conveying the separate infusion tube set to the administration site;
At the administration site, the other package of the other infusion tube set is opened and the other tube assembly is removed, and the other proximal adapter is connected to the other infusion container containing a secondary drug, Setting another tip connector on the patient side;
At the administration site, the zipper of the bag of the infusion tube set is opened to take out the tube assembly and the infusion container, and the tip connector thereof is connected to the other infusion tube set that has been transported in advance. Connecting to said another intermediate connector of the tube assembly;
The tube assembly and the infusion container of the infusion tube set that have been used after the administration of the dangerous drug at the administration site, and the other tube assembly and the another infusion container of the another infusion tube set In the bag and closing the zipper;
Transporting and discarding the bag from the administration site to a disposal site;
A method of using an infusion tube set, comprising:   A bag adapted to contain and transport and dispose of instruments with hazardous chemicals, and has a zipper that can be opened and closed at the opening, and is thick enough to impede hazardous chemicals A bag characterized by that.

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