WO2017163789A1 - Raccord médical et ensemble de perfusion - Google Patents

Raccord médical et ensemble de perfusion Download PDF

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Publication number
WO2017163789A1
WO2017163789A1 PCT/JP2017/007970 JP2017007970W WO2017163789A1 WO 2017163789 A1 WO2017163789 A1 WO 2017163789A1 JP 2017007970 W JP2017007970 W JP 2017007970W WO 2017163789 A1 WO2017163789 A1 WO 2017163789A1
Authority
WO
WIPO (PCT)
Prior art keywords
flow path
valve body
medical connector
pressure
downstream side
Prior art date
Application number
PCT/JP2017/007970
Other languages
English (en)
Japanese (ja)
Inventor
健 角田
和矢 秋山
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 WO2017163789A1 publication Critical patent/WO2017163789A1/fr

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Classifications

    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/24—Check- or non-return valves
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body

Definitions

  • the present invention relates to a medical connector and an infusion set.
  • an infusion set that constitutes a flow path for transporting a liquid such as a chemical solution is generally used.
  • the infusion set is configured by connecting members such as an infusion tube, various medical devices, and a medical connector.
  • the present invention has been developed in view of the above situation, and in an infusion line, a valve body capable of realizing both a flow of fluid from the upstream side to the downstream side and a flow of fluid from the downstream side to the upstream side is provided.
  • An object of the present invention is to provide a medical connector and an infusion set.
  • a medical connector includes a connector main body having an inner wall that defines a flow path, a central portion having a communication portion that allows fluid to communicate in a direction along the flow path, and the central portion. And a valve body disposed in the flow path, and a reverse pressure that is a pressure from the downstream side to the upstream side of the flow path is applied to the valve body. And when the flow path is opened via the communication portion and a positive pressure, which is a pressure from the upstream side to the downstream side of the flow path, is applied, the flow is interposed between the peripheral edge portion and the inner wall. It is characterized by being configured to open the road.
  • the peripheral portion is deformed while being in contact with the valve body. It is preferable to provide the first structure.
  • a said 1st structure is a supported part which is supported by the said inner wall and covers the said center part in the downstream of the said flow path with respect to the said valve body.
  • the supported portion includes a contact portion that contacts the central portion when the positive pressure is applied, and a connecting portion that connects the contact portion and the inner wall, With The contact portion is preferably closer to the valve body than the connection portion in the direction along the flow path.
  • the connector body includes a second structure that can contact the peripheral edge, and the valve body is reverse pressure from the downstream side to the upstream side of the flow path.
  • the peripheral portion is deformed so as to be separated from the first structure while the peripheral portion is in contact with the second structure.
  • the second structure is positioned on the upstream side of the flow path with respect to the valve body, and has a reduced diameter that is smaller than the valve body through a step surface. Part.
  • the valve body when the back pressure is less than a predetermined value, the valve body is in a state in which the central portion is covered with the supported portion while the peripheral edge is in contact with the stepped surface. It is preferable to close the flow path while maintaining the above.
  • the first predetermined value when the predetermined value is the first predetermined value, the first predetermined value opens the flow path when the positive pressure is applied to the valve body.
  • the second predetermined value is preferably larger.
  • the valve body is in contact with the first structure on the downstream side of the flow path, and is in contact with the second structure on the upstream side of the flow path. It is preferable to be positioned in the flow path.
  • the communication part is preferably a slit or a through hole.
  • the medical connector of the present invention includes a connector main body having an inner wall that defines a flow path, a central portion having a communication portion that allows fluid to communicate in a direction along the flow path, and And a valve body that is disposed in the flow path and has a peripheral edge located around the center part, and the valve body has a positive pressure that is a pressure from the upstream side to the downstream side of the flow path.
  • the flow path is opened through the communication portion, and when a reverse pressure, which is a pressure from the downstream side to the upstream side of the flow path, is applied, the gap between the peripheral edge portion and the inner wall is applied. It is configured to open the flow path.
  • the infusion set of the present invention is characterized by including the above-described medical connector.
  • achieve both the flow of the fluid from an upstream to a downstream and the flow of the fluid from a downstream to an upstream are provided. can do.
  • FIG. 2 is a cross-sectional view taken along line AA of the medical connector shown in FIG.
  • FIG. 2 is a cross-sectional view taken along line BB of the medical connector shown in FIG.
  • It is a longitudinal cross-sectional view in the state where the back pressure was applied to the flow path of the medical connector shown in FIG.
  • It is a longitudinal cross-sectional view in the state where the positive pressure was applied to the flow path of the medical connector shown in FIG.
  • It is a figure which shows the modification of the valve body with which the medical connector shown in FIG. 1 is provided.
  • It is a longitudinal cross-sectional view of the modification of the medical connector shown in FIG.
  • It is a front view of an infusion set provided with the medical connector which concerns on one Embodiment of this invention.
  • the upstream side of the flow channel means the right side in FIGS. 1, 4, 5, and 7, and the downstream side of the flow channel means the opposite side.
  • the medical connector 1 is a longitudinal sectional view, a sectional view taken along the line AA, and a sectional view taken along the line BB, respectively, of the medical connector 1 according to the present embodiment.
  • the pressure from the upstream side to the downstream side of the flow channel 14 (hereinafter referred to as “positive pressure” as appropriate) is also the pressure from the downstream side to the upstream side of the flow channel 14 (hereinafter, referred to as “positive pressure”).
  • the medical connector 1 is shown in a state where it is not applied (referred to as “back pressure” as appropriate) (hereinafter referred to as “non-pressure state” where appropriate).
  • the medical connector 1 includes a connector main body 10 and a valve body 30.
  • the valve body 30 has a central portion 31 and a peripheral edge portion 35 and is disposed in the flow path 14 defined by the connector main body 10.
  • the central portion 31 has a communication portion 32 that allows fluid to communicate in a direction along the flow path 14.
  • the communication part 32 is a slit 33 as shown in FIG.
  • the peripheral edge portion 35 is located around the central portion 31.
  • the valve body 30 of this example has a circular flat shape, and the central portion 31 and the peripheral portion 35 are integrally formed.
  • Examples of the material of the valve body 30 include natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, hydrin rubber, urethane rubber, silicone rubber, and fluorine rubber.
  • Various thermoplastic materials such as styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, chlorinated polyethylene, etc. Is mentioned.
  • the connector body 10 has an inner wall 13 that partitions the flow path 14. Moreover, the connector main body 10 is comprised by the 1st member 11 and the 2nd member 12 which were mutually connected in this example.
  • the connector main body 10 includes a first structure 15 and a second structure 19.
  • the first structure 15 is a supported portion 16 that is supported by the inner wall 13 and covers the central portion 31 on the downstream side of the flow path 14 with respect to the valve body 30.
  • the supported portion 16 is configured as a part of the first member 11.
  • the supported portion 16 includes a contact portion 17 that contacts the central portion 31 of the valve body 30 when a positive pressure is applied, and a connecting portion 18 that connects the contact portion 17 and the inner wall 13.
  • the contact portion 17 is closer to the valve body 30 than the connecting portion 18 in the direction along the flow path 14. That is, the contact part 17 protrudes to the upstream side of the flow path 14 from the connection part 18, and has a cylindrical shape in this example.
  • the connecting portion 18 is composed of a plurality of (four in this example) rod-like portions protruding from the abutting portion 17 toward the radially outer side of the abutting portion 17. Between these rod-shaped parts, an opening 18 a communicating in the direction along the flow path 14 is formed.
  • the second structure 19 can be in contact with the peripheral edge 35. Further, in this example, the second structure 19 is located on the upstream side of the flow path 14 with respect to the valve body 30, and is a reduced diameter portion 20 having a diameter smaller than that of the valve body 30 through the step surface 21. is there. The reduced diameter portion 20 is configured as a part of the second member 12 in this example.
  • Examples of the material of the connector main body 10 include polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymer; ethylene-vinyl acetate copolymer (EVA); polyvinyl chloride; polyvinylidene chloride; polystyrene; polyamide; polyimide; Polyimide (polymethyl 4-pentene-1); ionomer; acrylic resin; polymethyl methacrylate; acrylonitrile-butadiene-styrene copolymer (ABS resin); acrylonitrile-styrene copolymer (AS resin); butadiene- Styrene copolymer; Polyester such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycyclohexane terephthalate (PCT); polyether; polyether ketone Polyether ether ketone (PEEK); Polyetherimide; Polyacetal (POM); Polyphenylene oxide;
  • the valve body 30 comes into contact with the first structure 15 on the downstream side of the flow path 14 and contacts the second structure 19 on the upstream side of the flow path 14. Is positioned inside.
  • the valve body 30 is, as shown in FIG. 1, in the non-pressure state, the supported portion 16 as the first structure 15, specifically, the contact portion 17 on the downstream side of the flow path 14. In contact with the reduced diameter portion 20 as the second structure 19, specifically, the stepped surface 21 of the reduced diameter portion 20 on the upstream side of the flow path 14. Yes.
  • first predetermined value When back pressure less than a predetermined value (hereinafter referred to as “first predetermined value” as appropriate) is applied to the flow path 14, the valve body 30 has a peripheral surface 35 with a stepped surface 21 as shown in FIG. 1.
  • the center part 31 is maintained in a state covered with the supported part 16 while being in contact with the flow path, and the flow path 14 is closed.
  • the communication part 32 of this example is the slit 33, as long as the slit 33 is in a closed state, the flow path 14 is in a closed state. Therefore, when the counter pressure less than the first predetermined value is applied to the flow path 14, it is only necessary to maintain the state in which the slit 33 is closed.
  • the abutment portion 17 may not be in contact with the central portion 31.
  • the peripheral portion 35 is deformed so that the central portion 31 is separated from the first structure 15 while being in contact with the second structure 19.
  • the peripheral portion 35 is in contact with the reduced diameter portion 20 as the second structure 19, while the central portion 31 is the supported portion 16 as the first structure 15, specifically the contact portion 17. Deforms away from. More specifically, the central portion 31 is deformed so as to be separated from the contact portion 17 as it goes radially inward.
  • the valve body 30 since the valve body 30 is in a state in which the slit 33 as the communication portion 32 is opened due to the deformation of the central portion 31, the valve body 30 is opened through the communication portion 32 as shown in FIG. Become.
  • the valve body 30 When a positive pressure less than the second predetermined value is applied to the flow path 14, the valve body 30 has the center portion 31 at the supported portion 16 while the peripheral edge portion 35 is in contact with the stepped surface 21 as shown in FIG. 1.
  • the channel 14 is closed while maintaining the state covered with the water.
  • the second predetermined value is smaller than the first predetermined value. That is, the first predetermined value is larger than the second predetermined value.
  • the clearance gap is formed between the peripheral part 35 of the valve body 30 and the inner wall 13 of the connector main body 10, the flow path 14 will be in the obstruct
  • the communication part 32 of the central part 31 may be in a state of not communicating because the slit 33 itself is closed, or may be in a state of not communicating by being covered by the contact part 17. .
  • the peripheral portion 35 of the valve body 30 is deformed while the central portion 31 is in contact with the contact portion 17.
  • the contact portion 17 of the supported portion 16 as the first structure 15 contacts the central portion 31 of the valve body 30.
  • the peripheral edge 35 is deformed. Specifically, the peripheral edge 35 is deformed so as to be separated from the inner wall 13 toward the outer side in the radial direction. At this time, since the valve body 30 creates a gap between the peripheral edge 35 and the inner wall 13 due to the deformation of the peripheral edge 35, the flow path is interposed between the peripheral edge 35 and the inner wall 13 as shown in FIG. 14 will be opened.
  • the valve body 30 when a reverse pressure equal to or higher than the first predetermined value is applied to the flow path 14, the valve body 30 opens the flow path 14 via the communication portion 32.
  • a positive pressure equal to or greater than the second predetermined value is applied to the flow path 14, the valve body 30 opens the flow path 14 through between the peripheral edge portion 35 and the inner wall 13. Therefore, according to the medical connector 1, both the flow of fluid from the upstream side to the downstream side and the flow of fluid from the downstream side to the upstream side in the infusion line are realized by a simple procedure of adjusting the suction pressure. Therefore, suction from the downstream side to the upstream side becomes possible.
  • the medical connector 1 alternately applies a reverse pressure equal to or higher than the first predetermined value and a positive pressure equal to or higher than the second predetermined value to the flow path 14, so that the fluid on the downstream side of the valve body 30 in the flow path 14. Both the flow of the fluid from the upstream side to the downstream side and the flow of the fluid from the downstream side to the upstream side can be realized without stagnation. Furthermore, since the valve body 30 opens the flow path 14 between the peripheral part 35 and the inner wall 13, the medical connector 1 tends to increase the flow rate when the fluid flows from the upstream side to the downstream side.
  • the medical connector 1 includes a connecting portion 18 on the downstream side of the valve body 30 in the flow path 14. Thereby, the medical connector 1 is caused by the turbulence generated by the fluid flowing from the upstream side to the downstream side between the peripheral edge portion 35 of the valve body 30 and the inner wall 13 trying to bypass the connecting portion 18. The fluid on the downstream side of the valve body 30 can flow downstream without being retained.
  • FIG. 6 shows a valve body 30 ′ that is a modification of the valve body 30.
  • the communication part 32 included in the valve body 30 ′ may be a through hole 34.
  • the communication portion 32 is the through hole 34
  • the state where the through hole 34 is closed is maintained when a reverse pressure less than the first predetermined value is applied to the flow path 14 (see FIG. 1). Therefore, the contact portion 17 of the supported portion 16 is in a state of being in contact with the central portion 31 while covering the through hole 34.
  • the positive pressure less than the second predetermined value is applied to the flow path 14 (see FIG. 1), it is necessary to maintain the state in which the through hole 34 is closed. 17 will be in the state which contacted the center part 31, with the through-hole 34 covered.
  • the medical connector 2 according to this modification has a configuration in which the left and right sides of the medical connector 1 shown in FIG. 1 are reversed, that is, the upstream side and the downstream side of the flow path 14 are reversed. Since the medical connector 2 has the same configuration as the medical connector 1 except that the upstream side and the downstream side of the flow path 14 are reversed, the description thereof is omitted.
  • the flow of fluid from the upstream side to the downstream side and the fluid flow from the downstream side to the upstream side in the infusion line can be performed with a simple technique of adjusting the suction pressure. Both flows can be realized and suction from the downstream side to the upstream side becomes possible.
  • FIG. 8 is a view showing an infusion set 100 including the medical connector 1 or 2.
  • the infusion set 100 constitutes an infusion line that connects from an infusion holder such as an infusion bag (not shown in FIG. 8) to an indwelling needle (not shown in FIG. 8).
  • the infusion set 100 includes a plurality of medical tubes 101, a drip tube 102 in which the flow rate of the infusion agent supplied from the infusion holder can be visually recognized, and a plurality of infusion agent flow rates in the medical tube 101.
  • the adjustment clamp 103 that can be changed to the state, the closing clamp 104 that closes the medical tube 101, the connection part 105 that can connect another medical device, and the medical that connects the plurality of medical tubes 101 Connector 1 or 2.
  • the several medical tube 101 of this embodiment is provided with the 1st medical tube 101a and the 2nd medical tube 101b.
  • the upstream end of the infusion line of the infusion set 100 is connected to the infusion holder, and the downstream end is connected to the indwelling needle, thereby Infusion can be performed.
  • a suction device such as a syringe
  • blood suction from a patient can be sucked from the downstream side to the upstream side.
  • the medical connector 1 or 2 is connected to the upstream side of the infusion line or It can be provided at any location on the downstream side.
  • the connector main body 10 has been described as being composed of two members, the first member 11 and the second member 12, but the connector main body 10 may be composed of one member. You may be comprised with the member or more.
  • the medical connector according to the present invention is not limited to the configuration of the medical connectors 1 and 2 described above, and may be, for example, a medical connector including an indwelling needle that is placed in a patient's vasculature.
  • a medical connector including an indwelling needle that is placed in a patient's vasculature.
  • the medical connectors 1 and 2 may be of a luer lock type so that they can be easily connected to another medical device such as the medical tube 101 (see FIG. 8).
  • the upstream and downstream configurations of the flow path 14 in the medical connector according to the present invention can be changed as appropriate according to the usage and the like, and the above-described configurations of the medical connectors 1 and 2 are used. It is not limited.

Abstract

La présente invention concerne un raccord médical et un ensemble de perfusion comportant : un corps principal de raccord ayant une paroi interne définissant un canal d'écoulement ; et un corps de soupape disposé à l'intérieur du canal d'écoulement et ayant une section centrale avec une section de communication permettant le passage de fluide dans la direction d'écoulement du canal d'écoulement, et une section de bord située autour de la section centrale. Le raccord médical et l'ensemble de perfusion sont conçus de telle sorte que lorsqu'une contre-pression, qui est une pression dans une direction du côté aval vers le côté amont du canal d'écoulement, est appliquée, le corps de soupape ouvre le canal d'écoulement par l'intermédiaire de la section de communication, et lorsqu'une pression positive, qui est une pression dans une direction du côté amont vers le côté aval du canal d'écoulement, est appliquée, le corps de soupape ouvre le canal d'écoulement avec un espace entre la section de bord et la paroi interne interposée entre celles-ci.
PCT/JP2017/007970 2016-03-24 2017-02-28 Raccord médical et ensemble de perfusion WO2017163789A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016060595 2016-03-24
JP2016-060595 2016-03-24

Publications (1)

Publication Number Publication Date
WO2017163789A1 true WO2017163789A1 (fr) 2017-09-28

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PCT/JP2017/007970 WO2017163789A1 (fr) 2016-03-24 2017-02-28 Raccord médical et ensemble de perfusion

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4332249A (en) * 1980-08-01 1982-06-01 Sherwood Medical Industries, Inc. Filter and valve assembly for hypodermic syringe
WO2014153302A1 (fr) * 2013-03-16 2014-09-25 Infield Medical, Llc Valve de dispositif de transfert

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4332249A (en) * 1980-08-01 1982-06-01 Sherwood Medical Industries, Inc. Filter and valve assembly for hypodermic syringe
WO2014153302A1 (fr) * 2013-03-16 2014-09-25 Infield Medical, Llc Valve de dispositif de transfert

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