WO2012002015A1 - Connection tool and indwelling needle assembly - Google Patents

Connection tool and indwelling needle assembly Download PDF

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Publication number
WO2012002015A1
WO2012002015A1 PCT/JP2011/058695 JP2011058695W WO2012002015A1 WO 2012002015 A1 WO2012002015 A1 WO 2012002015A1 JP 2011058695 W JP2011058695 W JP 2011058695W WO 2012002015 A1 WO2012002015 A1 WO 2012002015A1
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WO
WIPO (PCT)
Prior art keywords
flow path
state
needle
opening
connector
Prior art date
Application number
PCT/JP2011/058695
Other languages
French (fr)
Japanese (ja)
Inventor
秀憲 田邊
図師　泰伸
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 WO2012002015A1 publication Critical patent/WO2012002015A1/en

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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
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M5/1582—Double lumen needles
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M2005/3201—Coaxially assembled needle cannulas placed on top of another, e.g. needles having different diameters
    • 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
    • A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
    • 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
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
    • 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
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/064—Slit-valve
    • 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
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/066—Septum-like element

Definitions

  • the present invention relates to a connector and an indwelling needle assembly including the same.
  • an indwelling needle assembly connected to the infusion line is punctured into the patient's blood vessel and placed in place.
  • Such an indwelling needle assembly includes a hollow outer needle, a tubular outer needle hub fixed to the proximal end of the outer needle, an inner needle inserted into the outer needle and having a sharp needle tip at the tip, It is comprised by the inner needle hub fixed to the proximal end of the inner needle (for example, refer patent document 1).
  • the outer needle hub houses a valve body (hemostatic valve) and a tubular operation member that opens and closes the valve body.
  • the inner needle is removed from the outer needle while holding the outer needle by hand (see FIG. 2 of Patent Document 1).
  • the outer needle can be placed in the blood vessel.
  • the valve body in the outer needle hub is in the closed state, blood is prevented from leaking.
  • a tubular connector is connected to the proximal end portion of the outer needle hub (see FIG. 3 of Patent Document 1).
  • the operation member in the outer needle hub is pressed in the distal direction, and the valve body is expanded.
  • the said valve body will be in an open state and can administer an infusion solution from the connector side to the outer needle side.
  • the operating member is loosely fitted to the outer needle hub so that it can be easily moved along the longitudinal direction in the outer needle hub, that is, A gap is formed between the inner periphery of the outer needle hub and the outer periphery of the operation member.
  • the connector is connected to the outer needle hub and the valve body is opened, blood flows into the operation member, and further flows into the gap through the proximal end opening of the operation member. Once the blood flows into the gap, the blood stays there, and there is a problem that it becomes a bacterial growth source or a thrombus source. There is also a problem that the airtightness of the blood flow path passing through the outer needle hub cannot be maintained by the gap.
  • An object of the present invention is to provide a connector that can reliably maintain the airtightness in the flow channel when blood flows into the flow channel of the hub by flashback, and an indwelling needle assembly including the connector. To provide a solid.
  • the present invention provides: A hollow outer needle, A hub provided at a base end portion of the outer needle, having a flow channel communicating with the inside of the outer needle, and capable of connecting a tubular body to the flow channel from the base end side; A valve mechanism for blocking and opening the flow path, The valve mechanism is provided in the middle of the flow path, and has a valve body having an openable / closable opening / closing part made of an elastic material, and is supported so as to be movable along the longitudinal direction of the flow path.
  • a first state in which the opening / closing part is closed and the operation member is located on a proximal end side relative to the opening / closing part, and the pipe body from the first state to the flow path.
  • the second member moves in the distal direction and pushes the opening / closing part open.
  • It is a connection tool characterized by having the seal part which maintains the airtightness in the channel in the 2nd state.
  • the seal portion is provided on the outer peripheral portion of the operation member, and in close contact with the inner peripheral surface of the flow channel in the second state, maintains the airtightness in the flow channel. It is preferable that
  • the flow path has a taper portion having a tapered shape in which the inner diameter gradually decreases in the distal direction on the inner peripheral surface thereof.
  • the seal portion has a ring shape, and an outer diameter thereof is smaller than a maximum inner diameter of the taper portion and larger than a minimum inner diameter, and the seal portion is in any of the first state and the second state. It is preferable that it is located in the taper part.
  • the operation member has a member main body configured by a cylindrical body having both ends opened, It is preferable that the seal portion is constituted by a ring-shaped member separate from the member main body, and is fixed to the outer peripheral portion of the member main body by fitting.
  • the operation member has a member main body configured by a cylindrical body having both ends opened, It is preferable that the seal portion is formed of a protrusion that is formed integrally with the outer peripheral portion of the member main body and protrudes in a ring shape along the circumferential direction of the outer peripheral portion.
  • a gap is formed between the inner peripheral surface of the flow path and the seal portion, and the air in the flow path is interposed through the gap. It is preferable that the gas can be discharged.
  • the seal portion is provided on the inner peripheral surface of the flow path, and in close contact with the outer peripheral portion of the operation member in the second state, maintains the airtightness in the flow path. It is preferable that
  • the valve body has a function of urging the operation member toward the proximal direction in the second state.
  • the opening / closing part is composed of a plate-like part and a through-hole formed so as to penetrate in the thickness direction of the plate-like part.
  • At least one groove is formed on the outer periphery of the plate-like portion along the thickness direction.
  • the present invention provides: A connector of the present invention; An indwelling needle assembly comprising: an inner needle inserted through the outer needle in the first state.
  • the distal end portion of the member body has a tapered shape in which the outer diameter gradually decreases in the distal direction.
  • the said seal part is arrange
  • the seal portion has elasticity.
  • FIG. 1 is an exploded perspective view showing a first embodiment when the connector of the present invention is applied as an indwelling needle.
  • FIG. 2 is a longitudinal cross-sectional view sequentially showing the use state of the indwelling needle assembly of the present invention.
  • FIG. 3 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention.
  • FIG. 4 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention.
  • FIG. 5 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention.
  • FIG. 6 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention.
  • FIG. 7 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention.
  • FIG. 8 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention.
  • FIG. 9 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention.
  • FIG. 10 is a longitudinal sectional view of an operating member in the second embodiment when the connector of the present invention is applied to an indwelling needle.
  • FIG. 11 is a longitudinal sectional view showing a third embodiment when the connector of the present invention is applied to an indwelling needle.
  • FIG. 1 is an exploded perspective view showing a first embodiment in which the connector of the present invention is applied as an indwelling needle
  • FIGS. 2 to 9 are longitudinal cross-sectional views sequentially illustrating usage states of the indwelling needle assembly of the present invention.
  • FIG. 1 the right side in FIGS. 1 to 9 is referred to as “base end” and the left side is referred to as “tip”.
  • the indwelling needle assembly 1 includes an indwelling needle (connector) 11 and a puncture needle 12.
  • the indwelling needle assembly 1 is assembled by inserting the puncture needle 12 into the indwelling needle 11 and the assembled state shown in FIGS. 2 and 3, and the puncture needle 12 is removed from the indwelling needle 11, FIGS. The removal state shown can be taken.
  • the indwelling needle assembly 1 can puncture the living body surface in the assembled state.
  • the indwelling needle 11 can be indwelled on the surface of the living body by setting it in the extracted state.
  • a connector (tube body) 20 can be connected to the indwelling needle 11 placed on the surface of the living body (see FIGS. 6 and 7).
  • the connector 20 Before describing the indwelling needle assembly 1, the connector 20 will be described. As shown in FIGS. 6 and 7, the connector 20 is connected to the proximal end portion of the indwelling needle 11.
  • the connector 20 is formed of a circular tubular member, and has a tapered shape whose outer diameter gradually decreases in the distal direction. Thereby, when connecting the connector 20, the connector 20 can be easily inserted in the base end part of the indwelling needle 11, Therefore The connection operation can be performed easily.
  • a distal end portion of a tube (not shown) is connected to the proximal end portion of the connector 20.
  • a bag (not shown) filled with an infusion solution (liquid) Q is connected to the proximal end portion of the tube.
  • the infusion needle Q is supplied to the indwelling needle 11 from the bag in a connected state where the connector 20 is connected (see FIG. 7).
  • the connector 20 may further have a cylindrical lock portion disposed concentrically on the outer periphery thereof. It is preferable that a female screw that is screwed with a protrusion 32 of the outer needle hub 3 of the indwelling needle 11 to be described later is formed on the inner peripheral portion of the lock portion.
  • the indwelling needle assembly 1 As shown in FIGS. 1 to 9, the indwelling needle 11 blocks the hollow outer needle 2, the outer needle hub 3 fixed to the proximal end of the outer needle 2, and the flow path 31 of the outer needle hub 3. And a valve mechanism 6 to be opened.
  • the outer needle 2 is composed of a flexible tube having a certain degree of flexibility.
  • the constituent material of the outer needle 2 is preferably a resin material, particularly a soft resin material. Specific examples thereof include fluorine resins such as PTFE, ETFE, and PFA, olefin resins such as polyethylene and polypropylene, or A mixture thereof, polyurethane, polyester, polyamide, polyether nylon resin, a mixture of the olefin resin and an ethylene-vinyl acetate copolymer, and the like can be given.
  • the outer needle 2 has internal visibility. That is, the outer needle 2 is preferably composed of a transparent (colorless and transparent), colored transparent or translucent resin. Thereby, when the outer needle 2 secures a blood vessel, the flashback of the blood R flowing from the distal end opening 22 of the outer needle 2 can be visually confirmed.
  • an X-ray contrast agent such as barium sulfate, barium carbonate, bismuth carbonate and tungstic acid can be blended so that the outer needle 2 has a contrast function.
  • the outer needle hub 3 is fixed in a liquid-tight manner by the method.
  • the outer needle hub 3 is composed of a cylindrical member, and its inner cavity functions as a flow path 31 through which the blood R and the infusion agent Q pass.
  • the flow path 31 communicates with the lumen 21 of the outer needle 2.
  • the valve mechanism 6 is housed and disposed in the flow path 31.
  • the outer needle hub 3 uses the inner cavity portion as a storage portion for storing the valve mechanism 6 in addition to the flow path 31.
  • a tapered first tapered portion 312 in which the inner diameter of the inner peripheral surface 311 defining the flow channel 31 gradually decreases toward the distal end is formed at the distal end of the flow channel 31.
  • the taper-like 2nd taper part 314 which the internal diameter of the internal peripheral surface 311 reduces gradually toward a front end direction is formed in the base end part of the flow path 31.
  • the connector 20 can be inserted into the second tapered portion 314 from its proximal end side.
  • the inner peripheral surface 311 of the flow path 31 and the outer peripheral portion of the connector 20 are in close contact with each other, and thus liquid tightness is maintained.
  • an inner diameter of the inner peripheral surface 311 is reduced, that is, a reduced diameter portion 315 protruding from the inner peripheral surface 311 along the circumferential direction is formed.
  • the reduced diameter portion 315 is a portion that functions as a stopper that prevents the operation member 8 of the valve mechanism 6 from being detached from the flow path 31.
  • a pair of projecting portions 32 are formed to project from the outer peripheral portion of the proximal end of the outer needle hub 3. These protrusions 32 are disposed on opposite sides of each other via the central axis of the outer needle hub 3. As described above, when the connector 20 has the lock portion, when the connector 20 is connected to the outer needle hub 3, each protrusion 32 can be screwed into the lock portion, and thus the connection state is reliably maintained. be able to.
  • the valve mechanism 6 is accommodated in the outer needle hub 3.
  • the valve mechanism 6 shuts and opens the flow path 31 and includes a valve body 7 and an operation member 8 that opens and closes the valve body 7.
  • valve body 7 is installed in the middle of the flow path 31, that is, in a portion between the first tapered portion 312 and the second tapered portion 314.
  • the valve body 7 is made of an elastic material and is housed in the flow path 31 in a compressed state toward the central axis. Thereby, the valve body 7 is reliably fixed in the flow path 31.
  • a portion where the valve body 7 of the flow path 31 is installed and fixed is referred to as a “valve body installation portion 316”.
  • the valve element 7 has an opening / closing part 71 that can be opened and closed.
  • the opening / closing part 71 includes a plate-like part 711 having a disk shape and a through hole 712 formed in the plate-like part 711.
  • the plate-like portion 711 has a posture in which the surface is perpendicular to the longitudinal direction of the flow path 31.
  • the through-hole 712 is comprised by the slit penetrated in the thickness direction of the plate-shaped part 711, for example.
  • the shape of the slit is not particularly limited.
  • the slit shown in FIG. 1 has a single character shape, and may have a cross shape, a Y shape (t-shape), or the like. With such a configuration, the opening / closing part 71 is surely a part having a self-closing property.
  • a plurality of grooves 73 are formed in the outer peripheral portion of the plate-like portion 711 along the thickness direction. These grooves 73 are arranged at equal intervals along the circumferential direction of the outer peripheral portion of the plate-like portion 711.
  • Each groove 73 formed in this manner functions as an exhaust path for discharging the air G in the flow path 31 blocked by the valve body 7 when flashback occurs (see FIG. 3). By this exhaust, the portion of the flow path 31 on the downstream side of the valve body installation portion 316 can be filled with the blood R.
  • the number of grooves 73 formed is preferably a plurality as shown in the figure, but is not limited to this, and may be one, for example.
  • a protrusion 74 is formed to protrude from the base end surface of the plate-like portion 711.
  • the protrusion 74 is formed in a ring shape so as to surround the through hole 712 in plan view.
  • the operation member 8 is a member for opening / closing the opening / closing part 71 of the valve body 7.
  • the operation member 8 is supported so as to be movable along the longitudinal direction of the flow path 31.
  • the operating member 8 is positioned on the proximal end side relative to the opening / closing part 71 (see FIGS. 2 to 4), and the operating member from the first state.
  • the second state can be taken when 8 moves in the distal direction and penetrates the opening / closing part 71 to push the opening / closing part 71 open.
  • the opening / closing part 71 is closed by self-occlusion. Thereby, the flow path 31 is interrupted
  • the opening / closing part 71 is forcibly opened by the operation member 8.
  • the flow path 31 is opened between the distal end portion and the proximal end portion of the valve mechanism 6.
  • the distal end portion (tapered portion 83) of the operation member 8 protrudes from the distal end surface of the opening / closing portion 71.
  • the operation member 8 includes a member main body 81 formed of a cylindrical body and a seal portion 82 fixed to the member main body 81.
  • the member body 81 is open at both ends, and has a distal end opening 811 and a proximal end opening 812. Accordingly, the inner needle 4 of the puncture needle 12 can be inserted through the member main body 81 and the valve body 7 in an assembled state (see FIGS. 2 and 3).
  • a tapered portion 83 having a tapered shape whose outer diameter gradually decreases toward the distal end is formed at the distal end of the member main body 81.
  • An engaging portion 84 is formed to project in the middle of the member main body 81 in the longitudinal direction, that is, in the vicinity of the proximal end side of the tapered portion 83.
  • the engaging portion 84 is formed in a ring shape along the circumferential direction of the member main body 81. As shown in FIG. 2, the engaging portion 84 engages with the reduced diameter portion 315 of the outer needle hub 3 in the first state. Thereby, it is possible to prevent the operation member 8 from being separated from the flow path 31.
  • An installation portion 85 in which the seal portion 82 is installed is formed at the base end portion of the member main body 81.
  • the installation portion 85 is configured by a concave portion formed in a ring shape along the circumferential direction of the member main body 81.
  • the seal portion 82 is inserted into the installation portion 85 having such a shape.
  • the seal portion 82 is unintentionally detached from the member main body 81 even when the member main body 81 is moving in combination with the fitting of the seal portion 82 to the installation portion 85. Can be reliably prevented.
  • a pair of missing portions 813 are formed at the edge of the base end opening 812 of the member main body 81. These missing portions 813 are arranged on the opposite sides with respect to the central axis of the member main body 81.
  • Each of the defect portions 813 formed in this way functions as an exhaust port for discharging the air in the member main body 81 when the connector 20 is connected to the indwelling needle assembly 1. By this exhaust, residual air in the member main body 81 can be prevented.
  • the number of missing portions 813 formed in the present embodiment is two, but is not limited thereto, and may be one or three or more, for example.
  • the missing portion 813 may be omitted. In this case, it is preferable that a gap is formed between the operation member 8 and the outer needle hub 3 in the first state.
  • the seal part 82 is installed in the installation part 85 of the member main body 81.
  • the seal portion 82 can maintain airtightness in the flow path 31 of the outer needle hub 3.
  • the seal portion 82 is a ring-shaped member made of an elastic material that is separate from the member main body 81.
  • the cross-sectional shape of the seal portion 82 is circular in the present embodiment, but is not limited thereto, and may be, for example, a polygon such as a quadrangle, an ellipse, a V shape, or a U shape.
  • the inner diameter of the seal portion 82 in a natural state where no external force is applied may be the same as the outer diameter of the installation portion 85 of the member main body 81, but is preferably slightly smaller. When the inner diameter of the seal portion 82 is slightly smaller than the outer diameter of the installation portion 85, the seal portion 82 is fitted into the installation portion 85 and is securely fixed.
  • the outer diameter .phi.d 1 of the seal portion 82 in a natural state is intermediate in size between the largest internal diameter .phi.d 2max and minimum inside diameter .phi.d 2min second tapered portion 314, i.e., the second tapered portion 314 smaller than the maximum inner diameter .phi.d 2max, is set larger than the minimum inner diameter .phi.d 2min (see FIG. 2).
  • the seal part 82 can move within the range where the second taper part 314 is formed. As shown in FIGS. 2 to 4 and 9, in the first state, the seal portion 82 is separated from the inner peripheral surface 311 of the second taper portion 314 (channel 31). As a result, a gap 317 is formed between the outer peripheral surface 821 of the seal portion 82 and the inner peripheral surface 311 of the second tapered portion 314.
  • the blood R flows from the distal end opening 22 of the outer needle 2 and flows down the outer needle 2. That is, flashback occurs (see FIG. 3).
  • the blood R that has flowed down flows into the flow path 31 and pushes out the air G in the flow path 31 from the grooves 73 of the valve body 7.
  • the pushed air G is discharged into the atmosphere through the gap 317.
  • the seal portion 82 has the outer peripheral surface 821 in close contact with the inner peripheral surface 311 of the second taper portion 314. Thereby, the airtightness in the flow path 31 is reliably maintained.
  • the blood R also flows into the member main body 81 of the operation member 8, and further through the defect portion 813, the outer peripheral portion of the member main body 81 and the inner peripheral surface 311 of the outer needle hub 3. It is likely to flow into the space between the two (hereinafter referred to as “dead space 313”).
  • the airtightness of the dead space 313 that is a part of the flow path 31 is maintained by the seal portion 82, the blood R can be prevented from flowing into the dead space 313. Thereby, it is possible to prevent the blood R from staying in the dead space 313, and thus it is possible to prevent a problem that the staying blood R becomes a bacterial growth source or a thrombus source. it can.
  • the seal portion 82 has elasticity. Thereby, in the second state, the seal portion 82 is compressed between the member main body 81 and the second tapered portion 314 and elastically deformed. At this time, since a restoring force is generated in the seal portion 82, the adhesion force between the sealing portion 82 and the second taper portion 314 is increased by the restoring force, and the airtightness in the flow path 31 (dead space 313) is more reliable. Retained.
  • the seal portion 82 is separated from the second taper portion 314 until it reaches the second state, so that sliding resistance with the second taper portion 314 is suppressed. Therefore, the movement is performed smoothly.
  • the puncture needle 12 includes an inner needle 4 and an inner needle hub 5 fixed to the proximal end portion of the inner needle 4.
  • the inner needle 4 is inserted through the outer needle 2, and the distal end portion of the inner needle hub 5 is inserted and fitted into the proximal end portion of the outer needle hub 3.
  • the valve mechanism 6 of the indwelling needle 11 is in the first state, and the inner needle 4 passes through the valve body 7 and the operation member 8 all together.
  • the inner needle 4 has a sharp needle tip 41 at the tip.
  • the length of the inner needle 4 is set to such a length that at least the needle tip 41 protrudes from the distal end opening 22 of the outer needle 2 when in the assembled state.
  • the living body surface can be punctured by the protruding needle tip 41.
  • the inner needle 4 may be a solid needle or a hollow needle.
  • the inner needle 4 is a solid needle, it is possible to ensure sufficient strength while reducing the outer diameter. Further, by making the inner needle 4 a solid needle, when the puncture needle 12 is discarded after the operation is completed, it is possible to prevent blood from remaining inside the inner needle 4 or flowing out of the blood. it can.
  • the inner needle 4 is a hollow needle, when the inner needle 4 punctures a blood vessel, blood flows into the hollow portion of the inner needle 4, so that flashback of the blood R can be confirmed.
  • the inner needle 4 can be configured to have both a hollow portion and a solid portion (for example, a configuration in which the distal end side is hollow and the proximal end side is solid).
  • a groove (flow path) 44 is formed in a recessed manner along the longitudinal direction of the inner needle 4 in the outer peripheral portion of the tip of the inner needle 4.
  • the groove 44 functions as an introduction path for introducing the blood R into the lumen 21 of the outer needle 2 when the inner needle 4 is punctured into the blood vessel.
  • the blood R introduced from the groove 44 flows into the gap between the inner needle 4 and the outer needle 2 (see FIG. 3). Thereby, the flashback of blood R can be confirmed reliably from an early stage. Then, the blood R passes through the lumen 21 of the outer needle 2 and flows into the flow path 31 of the outer needle hub 3.
  • the inner needle 4 may have a tapered portion whose outer diameter gradually decreases in the distal direction.
  • Examples of the constituent material of the inner needle 4 include metal materials such as stainless steel, aluminum or an aluminum alloy, titanium or a titanium alloy.
  • the inner needle hub 5 is fixed to the proximal end portion of the inner needle 4. Further, the inner needle hub 5 is constituted by a tubular member, and when the inner needle 4 is a hollow needle, it is preferable that an air filter is installed at the proximal end opening.
  • the inner needle hub 5 and the outer needle hub 3 described above are each preferably made of a transparent (colorless and transparent), colored transparent or translucent resin to ensure internal visibility. Thereby, when the outer needle 2 secures a blood vessel, the flashback of the blood R flowing in through the groove 44 of the inner needle 4 described above can be visually confirmed.
  • the constituent material of the member main body 81 of the outer needle hub 3, the inner needle hub 5, and the operation member 8 is not particularly limited.
  • polyolefins such as polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyurethane, polyamide ,
  • resin materials such as polyester, polycarbonate, polybutadiene, and polyvinyl chloride.
  • the elastic material constituting the valve body 7 and the seal portion 82 of the operation member 8 is not particularly limited.
  • natural rubber isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene rubber, urethane rubber, nitrile rubber, acrylic rubber ,
  • Various rubber materials such as fluoro rubber and silicone rubber, various thermoplastic elastomers such as urethane, polyester, polyamide, olefin and styrene, or mixtures thereof
  • examples thereof include elastic materials, and among these elastic materials, it is particularly preferable to use isoprene rubber.
  • isoprene rubber is used as the constituent material of the valve body 7, there is an advantage that the compression set is small and the expiration date of the product becomes long.
  • the indwelling needle assembly 1 is in an assembled state.
  • an infusion bag filled with the infusion agent Q is connected to the connector 20 in advance, so that the infusion agent Q can be supplied.
  • the indwelling needle assembly 1 in an assembled state is grasped, and the patient's blood vessel is punctured.
  • the blood R flows into the proximal direction of the lumen 21 of the outer needle 2 through the groove 44 of the inner needle 4 due to blood pressure. This can be confirmed in the outer needle hub 3 (see FIG. 3).
  • the indwelling needle assembly 1 is further advanced toward the distal end by a minute distance.
  • the blood R that has flowed in can discharge the air G in the flow path 31 through the grooves 73 of the valve body 7 as described above. It reaches where 7 is located.
  • the outer needle hub 3 of the indwelling needle 11 is fixed to the skin with an adhesive tape or the like.
  • the connector 20 is connected to the outer needle hub 3 (see FIGS. 5 and 6).
  • the operation member 8 is pressed by the connector 20 and moves in the distal direction, and pushes the valve body 7 open.
  • the indwelling needle 11 will be in a 2nd state.
  • the seal portion 82 is not in contact with the inner peripheral surface 311 of the outer needle hub 3 until the second state is reached, that is, until immediately before the blood R starts to enter the member main body 81 of the operation member 8. (See FIG. 5).
  • the taper portion 83 of the operating member 8 penetrates the opening / closing portion 71 of the valve body 7, so that the biasing force in the proximal direction acts on the taper portion 83 by the opening / closing portion 71. is doing.
  • the connector 20 is removed from the indwelling needle 11
  • the pressing force applied to the operation member 8 by the connector 20 is released, and the operation member 8 is moved in the proximal direction by the urging force of the opening / closing portion 71. Moving.
  • the indwelling needle 11 returns to the first state, that is, the opening / closing part 71 is closed, and thus the infusion agent Q in the indwelling needle 11 is prevented from leaking (see FIG. 9).
  • FIG. 10 is a longitudinal sectional view of an operating member in the second embodiment when the connector of the present invention is applied to an indwelling needle.
  • base end the right side in FIG. 10
  • tip the left side
  • the present embodiment is the same as the first embodiment except that the configuration of the seal portion is different.
  • the seal portion 82 ⁇ / b> A is formed integrally with the proximal end outer peripheral portion of the member main body 81.
  • the seal portion 82A is a protrusion that protrudes in a ring shape along the circumferential direction of the base end outer peripheral portion of the member main body 81, that is, a flange formed by expanding the outer diameter of the base end outer peripheral portion of the member main body 81. It consists of
  • the member main body 81 and the seal portion 82A are integrally formed, the number of parts constituting the operation member 8A can be suppressed. Further, the operation member 8A can be easily manufactured, for example, by molding.
  • FIG. 11 is a longitudinal sectional view showing a third embodiment when the connector of the present invention is applied to an indwelling needle.
  • base end the right side in FIG. 11
  • tip the left side
  • This embodiment is the same as the first embodiment except that the installation position of the seal portion is different.
  • a seal portion 33 is disposed on the outer needle hub 3A.
  • the seal portion 33 is a ring-shaped member made of an elastic material.
  • the cross-sectional shape of the seal portion 33 is circular in the present embodiment, but is not limited thereto, and may be, for example, a polygon such as a quadrangle, an ellipse, a V shape, or a U shape.
  • a ring-shaped recess 318 is formed on the inner peripheral surface 311 of the flow path 31 on the proximal end side of the reduced diameter portion 315 along the circumferential direction.
  • the seal portion 33 is inserted and installed in the recess 318.
  • the outer peripheral surface 331 of the seal portion 33 provided in this manner is in close contact with the outer peripheral portion 814 of the operation member 8. Thereby, the airtightness in the flow path 31 is reliably maintained, so that the infusion of the infusion agent Q and the blood R into the dead space 313 can be prevented.
  • connection tool and indwelling needle assembly of this invention were demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises a connection tool and an indwelling needle assembly is the same. It can be replaced with any structure that can perform its function. Moreover, arbitrary components may be added.
  • the indwelling needle assembly (connector) of the present invention is used by being inserted into a blood vessel, for example, inserted into an abdominal cavity, thoracic cavity, lymphatic vessel, spinal canal, etc. It can also be applied to.
  • valve body is not limited to the one shown in the figure, and may be one constituted by, for example, a duckbill valve.
  • the seal portion is configured to be in close contact with the tapered portion of the outer needle hub in the second state, but is not limited thereto, for example, A protrusion protruding in a ring shape along the circumferential direction may be formed on the inner peripheral surface of the outer needle hub, and the outer needle hub may be configured to be in close contact with the protrusion.
  • the connector of the present invention includes a hollow outer needle, a hub provided at a proximal end portion of the outer needle, having a flow channel communicating with the inside of the outer needle, and capable of connecting a tubular body to the flow channel from the proximal end side.
  • a valve mechanism that shuts off / opens the flow path and the valve mechanism is provided in the middle of the flow path and has an openable / closable opening / closing portion made of an elastic material, along the longitudinal direction of the flow path And an operating member that opens and closes the opening / closing part, the opening / closing part is closed, and the operating member is located closer to the proximal end than the opening / closing part, and the first state
  • the operation member is pressed by the pipe body and can move to the distal end direction to push the opening / closing part, and the airtightness in the flow path is maintained in the second state.
  • a sealing portion When the pipe body is connected to the road, the operation member is pressed by the pipe body and can move to the distal end direction to push the opening / closing part, and the airtightness in the flow path is maintained in the second state.
  • the seal portion of the operating member is in close contact with the inner peripheral surface of the flow path of the hub, and the airtightness in the flow path is reliably maintained.
  • the blood tends to flow into the space between the operating member and the hub, which is also the blind spot of the flow path.
  • the seal portion since the airtightness of the space that is a part of the flow path is maintained by the seal portion, it is possible to prevent blood from flowing into the space. Thereby, it is possible to prevent blood from staying in the space, and thus it is possible to prevent a problem that the staying blood becomes a bacterial growth source or a thrombus source. Therefore, the connection tool of the present invention has industrial applicability.

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Abstract

A connection tool is provided with a hollow needle; a hub which is provided upon a proximal portion of an outer needle, has a channel in connection within the outer needle, and for which a tube is connectable to the channel from the proximal portion; and a valve mechanism for blocking and opening the channel; wherein the valve mechanism has a valve body which is provided in the middle of the channel and which has a closable opening portion constructed with elastic material, and an operating member which is supported so as to be movable along the longitudinal direction of the channel for performing opening and closing operations of the opening portion. The connection tool can take a first state in which the opening portion is closed and the operating member is positioned more toward the proximal side than toward the opening portion; or a second state in which, when the tubing is connected to the channel from the first state, the operating member is pressed with the tubing so as to move in the tip direction to push open the opening section. The connection tool has a sealing portion for maintaining air-tightness within the channel in the second state.

Description

接続具および留置針組立体Connector and indwelling needle assembly
　本発明は、接続具およびそれを備える留置針組立体に関する。 The present invention relates to a connector and an indwelling needle assembly including the same.
　患者に対し輸液を行う際などには、輸液ラインと接続される留置針組立体を患者の血管に穿刺し、留置してこれを行う。 When performing infusion for a patient, etc., an indwelling needle assembly connected to the infusion line is punctured into the patient's blood vessel and placed in place.
　このような留置針組立体は、中空の外針と、外針の基端に固着された管状の外針ハブと、外針内に挿入され、先端に鋭利な針先を有する内針と、内針の基端に固着された内針ハブとで構成されている（例えば、特許文献１参照）。また、外針ハブには、弁体（止血弁）と、当該弁体の開閉操作を行なう管状の操作部材とが収納されている。 Such an indwelling needle assembly includes a hollow outer needle, a tubular outer needle hub fixed to the proximal end of the outer needle, an inner needle inserted into the outer needle and having a sharp needle tip at the tip, It is comprised by the inner needle hub fixed to the proximal end of the inner needle (for example, refer patent document 1). The outer needle hub houses a valve body (hemostatic valve) and a tubular operation member that opens and closes the valve body.
　この留置針組立体を患者の血管に穿刺する際には、内針を外針内に挿入し、内針の針先を外針の先端から突出させた組立状態で（特許文献１の図１参照）穿刺操作を行う。そして、内針の針先が血管内に到達すると、針先の開口より流入した血液は、内針の内腔を通り、透明な内針ハブの内部に流入し、血液が視認される、いわゆるフラッシュバックが生じる。これにより、内針が血管を確保したことを確認することできる。このフラッシュバックを確認したら、外針を進め、外針を血管内に挿入する。 When this indwelling needle assembly is punctured into a patient's blood vessel, the inner needle is inserted into the outer needle, and the needle tip of the inner needle protrudes from the tip of the outer needle (FIG. 1 of Patent Document 1). (Ref.) Perform puncture operation. When the needle tip of the inner needle reaches the blood vessel, the blood that flows in from the opening of the needle tip passes through the lumen of the inner needle, flows into the transparent inner needle hub, and blood is visually recognized. Flashback occurs. Thereby, it can be confirmed that the inner needle has secured the blood vessel. When this flashback is confirmed, the outer needle is advanced and the outer needle is inserted into the blood vessel.
　次いで、外針を手で押さえつつ、当該外針から内針を抜き取る（特許文献１の図２参照）。これにより、外針を血管に留置することができる。また、このとき、外針ハブ内の弁体が閉状態となっているため、血液が漏出するのが防止されている。 Next, the inner needle is removed from the outer needle while holding the outer needle by hand (see FIG. 2 of Patent Document 1). Thereby, the outer needle can be placed in the blood vessel. At this time, since the valve body in the outer needle hub is in the closed state, blood is prevented from leaking.
　次いで、外針ハブの基端部に管状のコネクタを接続する（特許文献１の図３参照）。この接続されたコネクタにより、外針ハブ内の操作部材が先端方向に押圧されて、弁体を押し広げる。これにより、当該弁体が開状態となり、コネクタ側から外針側へ輸液剤を投与することができる。 Next, a tubular connector is connected to the proximal end portion of the outer needle hub (see FIG. 3 of Patent Document 1). By the connected connector, the operation member in the outer needle hub is pressed in the distal direction, and the valve body is expanded. Thereby, the said valve body will be in an open state and can administer an infusion solution from the connector side to the outer needle side.
　さて、特許文献１に記載の留置針組立体では、操作部材は、外針ハブ内をその長手方向に沿って容易に移動することができるように、外針ハブに対し遊嵌した状態、すなわち、外針ハブの内周部と操作部材の外周部との間に間隙が形成されている。そして、外針ハブにコネクタを接続して、弁体が開状態となると、操作部材にも血液が流入することとなり、さらには操作部材の基端開口を経て前記間隙にも流れ込んでしまう。前記間隙に一旦血液が流れ込むと、当該血液は、そこで滞留してしまい、細菌の増殖源となったり、血栓源となったりするという問題があった。また、前記間隙によって、外針ハブ内を通過する血液の流路の気密性を保持することができないという問題もあった。 Now, in the indwelling needle assembly described in Patent Document 1, the operating member is loosely fitted to the outer needle hub so that it can be easily moved along the longitudinal direction in the outer needle hub, that is, A gap is formed between the inner periphery of the outer needle hub and the outer periphery of the operation member. When the connector is connected to the outer needle hub and the valve body is opened, blood flows into the operation member, and further flows into the gap through the proximal end opening of the operation member. Once the blood flows into the gap, the blood stays there, and there is a problem that it becomes a bacterial growth source or a thrombus source. There is also a problem that the airtightness of the blood flow path passing through the outer needle hub cannot be maintained by the gap.
特開２００２－２６３１９７号公報JP 2002-263197 A
　本発明の目的は、フラッシュバックにより血液がハブの流路内に流入した際に、当該流路内の気密性を確実に保持することができる接続具、および、かかる接続具を備える留置針組立体を提供することにある。 An object of the present invention is to provide a connector that can reliably maintain the airtightness in the flow channel when blood flows into the flow channel of the hub by flashback, and an indwelling needle assembly including the connector. To provide a solid.
　上記目的を達成するために、本発明は、
　中空の外針と、
　前記外針の基端部に設けられ、該外針内と連通する流路を有し、該流路に基端側から管体を接続可能なハブと、
　前記流路を遮断・開放する弁機構とを備え、
　前記弁機構は、前記流路の途中に設けられ、弾性材料で構成された開閉可能な開閉部を有する弁体と、前記流路の長手方向に沿って移動可能に支持され、前記開閉部を開閉操作する操作部材とを有し、前記開閉部が閉じ、該開閉部よりも前記操作部材が基端側に位置する第１の状態と、前記第１の状態から前記流路に前記管体を接続した際に、該管体で前記操作部材が押圧されて先端方向に移動し前記開閉部を押し開く第２の状態とを取り得、
　前記第２の状態で前記流路内の気密性を保持するシール部を有することを特徴とする接続具である。 In order to achieve the above object, the present invention provides:
A hollow outer needle,
A hub provided at a base end portion of the outer needle, having a flow channel communicating with the inside of the outer needle, and capable of connecting a tubular body to the flow channel from the base end side;
A valve mechanism for blocking and opening the flow path,
The valve mechanism is provided in the middle of the flow path, and has a valve body having an openable / closable opening / closing part made of an elastic material, and is supported so as to be movable along the longitudinal direction of the flow path. A first state in which the opening / closing part is closed and the operation member is located on a proximal end side relative to the opening / closing part, and the pipe body from the first state to the flow path. When the operation member is pressed by the tube body, the second member moves in the distal direction and pushes the opening / closing part open.
It is a connection tool characterized by having the seal part which maintains the airtightness in the channel in the 2nd state.
　また、本発明の接続具では、前記シール部は、前記操作部材の外周部に設けられ、前記第２の状態で前記流路の内周面に密着して前記流路内の気密性を保持するものであるのが好ましい。 Moreover, in the connection tool of the present invention, the seal portion is provided on the outer peripheral portion of the operation member, and in close contact with the inner peripheral surface of the flow channel in the second state, maintains the airtightness in the flow channel. It is preferable that
　また、本発明の接続具では、前記流路は、その内周面に内径が先端方向に向かって漸減するテーパ状をなすテーパ部を有し、
　前記シール部は、リング状をなし、その外径が前記テーパ部の最大内径よりも小さく、最小内径よりも大きいものであり、前記第１の状態および前記第２の状態のいずれの状態で前記テーパ部に位置しているのが好ましい。 Further, in the connection tool of the present invention, the flow path has a taper portion having a tapered shape in which the inner diameter gradually decreases in the distal direction on the inner peripheral surface thereof.
The seal portion has a ring shape, and an outer diameter thereof is smaller than a maximum inner diameter of the taper portion and larger than a minimum inner diameter, and the seal portion is in any of the first state and the second state. It is preferable that it is located in the taper part.
　また、本発明の接続具では、前記操作部材は、両端がそれぞれ開口した筒体で構成された部材本体を有し、
　前記シール部は、前記部材本体と別体のリング状をなす部材で構成され、前記部材本体の外周部に嵌合により固定されているのが好ましい。 Moreover, in the connection tool of the present invention, the operation member has a member main body configured by a cylindrical body having both ends opened,
It is preferable that the seal portion is constituted by a ring-shaped member separate from the member main body, and is fixed to the outer peripheral portion of the member main body by fitting.
　また、本発明の接続具では、前記操作部材は、両端がそれぞれ開口した筒体で構成された部材本体を有し、
　前記シール部は、前記部材本体の外周部に一体的に形成され、該外周部の周方向に沿ってリング状に突出した突部で構成されているのが好ましい。 Moreover, in the connection tool of the present invention, the operation member has a member main body configured by a cylindrical body having both ends opened,
It is preferable that the seal portion is formed of a protrusion that is formed integrally with the outer peripheral portion of the member main body and protrudes in a ring shape along the circumferential direction of the outer peripheral portion.
　また、本発明の接続具では、前記第１の状態では、前記流路の内周面と前記シール部との間に間隙が形成されており、該間隙を介して、前記流路内の空気を排出可能であるのが好ましい。 In the connecting device of the present invention, in the first state, a gap is formed between the inner peripheral surface of the flow path and the seal portion, and the air in the flow path is interposed through the gap. It is preferable that the gas can be discharged.
　また、本発明の接続具では、前記シール部は、前記流路の内周面に設けられ、前記第２の状態で前記操作部材の外周部に密着して前記流路内の気密性を保持するものであるのが好ましい。 In the connecting device of the present invention, the seal portion is provided on the inner peripheral surface of the flow path, and in close contact with the outer peripheral portion of the operation member in the second state, maintains the airtightness in the flow path. It is preferable that
　また、本発明の接続具では、前記弁体は、前記第２の状態で前記操作部材を基端方向に向かって付勢する機能を有するのが好ましい。 Moreover, in the connection tool of the present invention, it is preferable that the valve body has a function of urging the operation member toward the proximal direction in the second state.
　また、本発明の接続具では、前記開閉部は、板状部と、該板状部の厚さ方向に貫通して形成された貫通孔とで構成されているのが好ましい。 Moreover, in the connection tool of the present invention, it is preferable that the opening / closing part is composed of a plate-like part and a through-hole formed so as to penetrate in the thickness direction of the plate-like part.
　また、本発明の接続具では、前記板状部には、その外周部に厚さ方向に沿って溝が少なくとも１本形成されているのが好ましい。 Moreover, in the connector according to the present invention, it is preferable that at least one groove is formed on the outer periphery of the plate-like portion along the thickness direction.
　上記目的を達成するために、本発明は、
　本発明の接続具と、
　前記第１の状態で前記外針に挿通される内針とを備えることを特徴とする留置針組立体である。 In order to achieve the above object, the present invention provides:
A connector of the present invention;
An indwelling needle assembly comprising: an inner needle inserted through the outer needle in the first state.
　また、本発明の接続具では、前記部材本体の先端部は、その外径が先端方向に向かって漸減したテーパ状をなすのが好ましい。 Moreover, in the connection tool of the present invention, it is preferable that the distal end portion of the member body has a tapered shape in which the outer diameter gradually decreases in the distal direction.
　また、本発明の接続具では、前記シール部は、前記部材本体の基端部に配置されているのが好ましい。
　また、本発明の接続具では、前記シール部は、弾性を有するのが好ましい。 Moreover, in the connector of this invention, it is preferable that the said seal part is arrange | positioned at the base end part of the said member main body.
In the connector according to the present invention, it is preferable that the seal portion has elasticity.
図１は、本発明の接続具を留置針として適用した場合の第１実施形態を示す分解斜視図である。FIG. 1 is an exploded perspective view showing a first embodiment when the connector of the present invention is applied as an indwelling needle. 図２は、本発明の留置針組立体の使用状態を順に示す縦断面図である。FIG. 2 is a longitudinal cross-sectional view sequentially showing the use state of the indwelling needle assembly of the present invention. 図３は、本発明の留置針組立体の使用状態を順に示す縦断面図である。FIG. 3 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention. 図４は、本発明の留置針組立体の使用状態を順に示す縦断面図である。FIG. 4 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention. 図５は、本発明の留置針組立体の使用状態を順に示す縦断面図である。FIG. 5 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention. 図６は、本発明の留置針組立体の使用状態を順に示す縦断面図である。FIG. 6 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention. 図７は、本発明の留置針組立体の使用状態を順に示す縦断面図である。FIG. 7 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention. 図８は、本発明の留置針組立体の使用状態を順に示す縦断面図である。FIG. 8 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention. 図９は、本発明の留置針組立体の使用状態を順に示す縦断面図である。FIG. 9 is a longitudinal cross-sectional view sequentially illustrating the use state of the indwelling needle assembly of the present invention. 図１０は、本発明の接続具を留置針に適用した場合の第２実施形態における操作部材の縦断面図である。FIG. 10 is a longitudinal sectional view of an operating member in the second embodiment when the connector of the present invention is applied to an indwelling needle. 図１１は、本発明の接続具を留置針に適用した場合の第３実施形態を示す縦断面図である。FIG. 11 is a longitudinal sectional view showing a third embodiment when the connector of the present invention is applied to an indwelling needle.
　以下、本発明の接続具および留置針組立体を添付図面に示す好適な実施形態に基づいて詳細に説明する。 Hereinafter, the connector and the indwelling needle assembly of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
　＜第１実施形態＞
  図１は、本発明の接続具を留置針として適用した場合の第１実施形態を示す分解斜視図、図２～図９は、それぞれ、本発明の留置針組立体の使用状態を順に示す縦断面図である。なお、以下では、説明の都合上、図１～図９中の右側を「基端」、左側を「先端」と言う。 <First Embodiment>
FIG. 1 is an exploded perspective view showing a first embodiment in which the connector of the present invention is applied as an indwelling needle, and FIGS. 2 to 9 are longitudinal cross-sectional views sequentially illustrating usage states of the indwelling needle assembly of the present invention. FIG. In the following, for convenience of explanation, the right side in FIGS. 1 to 9 is referred to as “base end” and the left side is referred to as “tip”.
　図２に示すように、留置針組立体１は、留置針（接続具）１１と穿刺針１２とで構成されている。この留置針組立体１は、留置針１１に穿刺針１２を挿入して組み立てた、図２、図３に示す組立状態と、留置針１１から穿刺針１２を抜去した、図４～図９に示す抜去状態とを取り得る。留置針組立体１は、組立状態で生体表面を穿刺することができる。その後、抜去状態とすることにより、留置針１１を生体表面に留置することができる。また、生体表面に留置された留置針１１にコネクタ（管体）２０を接続することができる（図６、図７参照）。 As shown in FIG. 2, the indwelling needle assembly 1 includes an indwelling needle (connector) 11 and a puncture needle 12. The indwelling needle assembly 1 is assembled by inserting the puncture needle 12 into the indwelling needle 11 and the assembled state shown in FIGS. 2 and 3, and the puncture needle 12 is removed from the indwelling needle 11, FIGS. The removal state shown can be taken. The indwelling needle assembly 1 can puncture the living body surface in the assembled state. Then, the indwelling needle 11 can be indwelled on the surface of the living body by setting it in the extracted state. In addition, a connector (tube body) 20 can be connected to the indwelling needle 11 placed on the surface of the living body (see FIGS. 6 and 7).
　留置針組立体１について説明する前に、コネクタ２０について説明する。
　図６、図７に示すように、コネクタ２０は、留置針１１の基端部に接続されるものである。このコネクタ２０は、円管状の部材で構成され、その外径が先端方向に向かって漸減したテーパ状をなしている。これにより、コネクタ２０を接続する際に、コネクタ２０を留置針１１の基端部に容易に挿入することができ、よって、その接続操作を容易に行なうことができる。 Before describing the indwelling needle assembly 1, the connector 20 will be described.
As shown in FIGS. 6 and 7, the connector 20 is connected to the proximal end portion of the indwelling needle 11. The connector 20 is formed of a circular tubular member, and has a tapered shape whose outer diameter gradually decreases in the distal direction. Thereby, when connecting the connector 20, the connector 20 can be easily inserted in the base end part of the indwelling needle 11, Therefore The connection operation can be performed easily.
　また、コネクタ２０の基端部には、チューブ（図示せず）の先端部が接続されている。そして、チューブの基端部には、輸液剤（液体）Ｑが充填されたバッグ（図示せず）が接続されている。留置針１１は、コネクタ２０が接続された接続状態で、前記バッグからの輸液剤Ｑが供給される（図７参照）。 Further, a distal end portion of a tube (not shown) is connected to the proximal end portion of the connector 20. A bag (not shown) filled with an infusion solution (liquid) Q is connected to the proximal end portion of the tube. The infusion needle Q is supplied to the indwelling needle 11 from the bag in a connected state where the connector 20 is connected (see FIG. 7).
　なお、コネクタ２０は、その外周部に同心的に配置された筒状をなすロック部をさらに有するものであってもよい。このロック部の内周部には、後述する留置針１１の外針ハブ３の突部３２と螺合する雌ネジが形成されているのが好ましい。 In addition, the connector 20 may further have a cylindrical lock portion disposed concentrically on the outer periphery thereof. It is preferable that a female screw that is screwed with a protrusion 32 of the outer needle hub 3 of the indwelling needle 11 to be described later is formed on the inner peripheral portion of the lock portion.
　次に、留置針組立体１について説明する。
　図１～図９に示すように、留置針１１は、中空の外針２と、外針２の基端部に固定された外針ハブ３と、外針ハブ３の流路３１を遮断・開放する弁機構６とを有している。 Next, the indwelling needle assembly 1 will be described.
As shown in FIGS. 1 to 9, the indwelling needle 11 blocks the hollow outer needle 2, the outer needle hub 3 fixed to the proximal end of the outer needle 2, and the flow path 31 of the outer needle hub 3. And a valve mechanism 6 to be opened.
　外針２は、ある程度の可撓性を有する可撓管で構成されている。この外針２の構成材料は、樹脂材料、特に、軟質樹脂材料が好適であり、その具体例としては、例えば、ＰＴＦＥ、ＥＴＦＥ、ＰＦＡ等のフッ素系樹脂、ポリエチレン、ポリプロピレン等のオレフィン系樹脂またはこれらの混合物、ポリウレタン、ポリエステル、ポリアミド、ポリエーテルナイロン樹脂、前記オレフィン系樹脂とエチレン－酢酸ビニル共重合体との混合物等が挙げられる。 The outer needle 2 is composed of a flexible tube having a certain degree of flexibility. The constituent material of the outer needle 2 is preferably a resin material, particularly a soft resin material. Specific examples thereof include fluorine resins such as PTFE, ETFE, and PFA, olefin resins such as polyethylene and polypropylene, or A mixture thereof, polyurethane, polyester, polyamide, polyether nylon resin, a mixture of the olefin resin and an ethylene-vinyl acetate copolymer, and the like can be given.
　このような外針２は、その全部または一部が内部の視認性を有しているのが好ましい。すなわち、外針２は、透明（無色透明）、着色透明または半透明の樹脂で構成されているのが好ましい。これにより、外針２が血管を確保した際、外針２の先端開口２２から流入する血液Ｒのフラッシュバックを目視で確認することができる。 It is preferable that all or part of the outer needle 2 has internal visibility. That is, the outer needle 2 is preferably composed of a transparent (colorless and transparent), colored transparent or translucent resin. Thereby, when the outer needle 2 secures a blood vessel, the flashback of the blood R flowing from the distal end opening 22 of the outer needle 2 can be visually confirmed.
　また、外針２の構成材料中には、例えば硫酸バリウム、炭酸バリウム、炭酸ビスマス、タングステン酸のようなＸ線造影剤を配合し、外針２に造影機能を持たせることもできる。 Further, in the constituent material of the outer needle 2, for example, an X-ray contrast agent such as barium sulfate, barium carbonate, bismuth carbonate and tungstic acid can be blended so that the outer needle 2 has a contrast function.
　図１（図２～図９についても同様）に示すように、外針２の基端部には、例えば、カシメ、融着（熱融着、高周波融着等）、接着剤による接着等の方法により、外針ハブ３が液密に固定されている。 As shown in FIG. 1 (the same applies to FIGS. 2 to 9), for example, caulking, fusion (thermal fusion, high-frequency fusion, etc.), adhesion with an adhesive, etc. The outer needle hub 3 is fixed in a liquid-tight manner by the method.
　外針ハブ３は、円筒状部材で構成され、その内腔部が、血液Ｒや輸液剤Ｑが通過する流路３１として機能するものである。この流路３１は、外針２の内腔２１と連通している。また、流路３１には、弁機構６が収納、配置されている。このように外針ハブ３は、その内腔部を流路３１の他に、弁機構６を収納する収納部としても利用したものとなっている。 The outer needle hub 3 is composed of a cylindrical member, and its inner cavity functions as a flow path 31 through which the blood R and the infusion agent Q pass. The flow path 31 communicates with the lumen 21 of the outer needle 2. Further, the valve mechanism 6 is housed and disposed in the flow path 31. As described above, the outer needle hub 3 uses the inner cavity portion as a storage portion for storing the valve mechanism 6 in addition to the flow path 31.
　流路３１の先端部には、該流路３１を画成する内周面３１１の内径が先端方向に向かって漸減するテーパ状の第１のテーパ部３１２が形成されている。これにより、流路３１を先端方向に向かって流下した輸液剤Ｑが、外針２に容易に導入されることとなる。 A tapered first tapered portion 312 in which the inner diameter of the inner peripheral surface 311 defining the flow channel 31 gradually decreases toward the distal end is formed at the distal end of the flow channel 31. As a result, the infusion agent Q that has flowed down the flow path 31 in the distal direction is easily introduced into the outer needle 2.
　流路３１の基端部には、内周面３１１の内径が先端方向に向かって漸減するテーパ状の第２のテーパ部３１４が形成されている。図６に示すように、第２のテーパ部３１４には、その基端側からコネクタ２０を挿入することができる。流路３１にコネクタ２０を挿入すると、流路３１の内周面３１１とコネクタ２０の外周部とが密着し、よって、液密性が維持される。 The taper-like 2nd taper part 314 which the internal diameter of the internal peripheral surface 311 reduces gradually toward a front end direction is formed in the base end part of the flow path 31. As shown in FIG. As shown in FIG. 6, the connector 20 can be inserted into the second tapered portion 314 from its proximal end side. When the connector 20 is inserted into the flow path 31, the inner peripheral surface 311 of the flow path 31 and the outer peripheral portion of the connector 20 are in close contact with each other, and thus liquid tightness is maintained.
　第２のテーパ部３１４の先端側直近には、内周面３１１の内径が縮径した、すなわち、内周面３１１からその周方向に沿ってリング状の突出した縮径部３１５が形成されている。この縮径部３１５は、弁機構６の操作部材８が流路３１から離脱するのを防止するストッパとして機能する部分である。 Near the distal end side of the second taper portion 314, an inner diameter of the inner peripheral surface 311 is reduced, that is, a reduced diameter portion 315 protruding from the inner peripheral surface 311 along the circumferential direction is formed. Yes. The reduced diameter portion 315 is a portion that functions as a stopper that prevents the operation member 8 of the valve mechanism 6 from being detached from the flow path 31.
　また、図１に示すように、外針ハブ３の基端外周部には、一対の突部３２が突出形成されている。これらの突部３２は、外針ハブ３の中心軸を介して互いに反対側に配置されている。前述したようにコネクタ２０がロック部を有する場合、コネクタ２０を外針ハブ３に接続した際、各突部３２がロック部に螺合することができ、よって、その接続状態を確実に維持することができる。 Further, as shown in FIG. 1, a pair of projecting portions 32 are formed to project from the outer peripheral portion of the proximal end of the outer needle hub 3. These protrusions 32 are disposed on opposite sides of each other via the central axis of the outer needle hub 3. As described above, when the connector 20 has the lock portion, when the connector 20 is connected to the outer needle hub 3, each protrusion 32 can be screwed into the lock portion, and thus the connection state is reliably maintained. be able to.
　外針ハブ３には、弁機構６が収納されている。この弁機構６は、流路３１を遮断・開放するものであり、弁体７と、弁体７を開閉操作する操作部材８とで構成されている。 The valve mechanism 6 is accommodated in the outer needle hub 3. The valve mechanism 6 shuts and opens the flow path 31 and includes a valve body 7 and an operation member 8 that opens and closes the valve body 7.
　図２に示すように、弁体７は、流路３１の途中、すなわち、第１のテーパ部３１２と第２のテーパ部３１４との間の部分に設置されている。この弁体７は、弾性材料で構成され、流路３１内にその中心軸側に向かって圧縮状態で収納されている。これにより、弁体７が流路３１内に確実に固定される。以下、流路３１の弁体７が設置、固定されている部分を「弁体設置部３１６」と言う。 As shown in FIG. 2, the valve body 7 is installed in the middle of the flow path 31, that is, in a portion between the first tapered portion 312 and the second tapered portion 314. The valve body 7 is made of an elastic material and is housed in the flow path 31 in a compressed state toward the central axis. Thereby, the valve body 7 is reliably fixed in the flow path 31. Hereinafter, a portion where the valve body 7 of the flow path 31 is installed and fixed is referred to as a “valve body installation portion 316”.
　弁体７は、開閉可能な開閉部７１を有している。開閉部７１は、円板状をなす板状部７１１と、板状部７１１に形成された貫通孔７１２とで構成されている。板状部７１１は、その面が流路３１の長手方向に対して垂直な姿勢となっている。また、貫通孔７１２は、板状部７１１の厚さ方向に貫通した、例えばスリットで構成されている。このスリットの形状としては、特に限定されず、例えば図１に示す構成では一文字状となっており、その他、十文字状、Ｙ字状（ト字状）等であってもよい。このような構成により、開閉部７１は、確実に自己閉塞性を有する部分となる。 The valve element 7 has an opening / closing part 71 that can be opened and closed. The opening / closing part 71 includes a plate-like part 711 having a disk shape and a through hole 712 formed in the plate-like part 711. The plate-like portion 711 has a posture in which the surface is perpendicular to the longitudinal direction of the flow path 31. Moreover, the through-hole 712 is comprised by the slit penetrated in the thickness direction of the plate-shaped part 711, for example. The shape of the slit is not particularly limited. For example, the slit shown in FIG. 1 has a single character shape, and may have a cross shape, a Y shape (t-shape), or the like. With such a configuration, the opening / closing part 71 is surely a part having a self-closing property.
　図１に示すように、板状部７１１の外周部には、その厚さ方向に沿って複数本の溝７３が形成されている。これらの溝７３は、板状部７１１の外周部の周方向に沿って等間隔に配置されている。このように形成された各溝７３は、それぞれ、フラッシュバックが生じた際に、弁体７で遮断された流路３１内の空気Ｇを排出する排気路として機能する（図３参照）。この排気により、流路３１の弁体設置部３１６よりも下流側の部分を血液Ｒで満たすことができる。なお、溝７３の形成数は、図示の構成のように複数本あるのが好ましいが、これに限定されず、例えば、１本であってもよい。 As shown in FIG. 1, a plurality of grooves 73 are formed in the outer peripheral portion of the plate-like portion 711 along the thickness direction. These grooves 73 are arranged at equal intervals along the circumferential direction of the outer peripheral portion of the plate-like portion 711. Each groove 73 formed in this manner functions as an exhaust path for discharging the air G in the flow path 31 blocked by the valve body 7 when flashback occurs (see FIG. 3). By this exhaust, the portion of the flow path 31 on the downstream side of the valve body installation portion 316 can be filled with the blood R. The number of grooves 73 formed is preferably a plurality as shown in the figure, but is not limited to this, and may be one, for example.
　また、板状部７１１の基端面には、突部７４が突出形成されている。この突部７４は、平面視で貫通孔７１２を囲むようにリング状に形成されている。 Further, a protrusion 74 is formed to protrude from the base end surface of the plate-like portion 711. The protrusion 74 is formed in a ring shape so as to surround the through hole 712 in plan view.
　操作部材８は、弁体７の開閉部７１を開閉操作する部材である。この操作部材８は、流路３１の長手方向に沿って移動可能に支持されている。これにより、留置針１１（弁機構６）では、操作部材８が開閉部７１よりも基端側に位置する第１の状態（図２～図４参照）と、その第１の状態から操作部材８が先端方向に移動して開閉部７１を貫通し、当該開閉部７１を押し開く第２の状態（図６および図７参照）とを取り得る。また、第１の状態では、開閉部７１が自己閉塞性によって閉じたものとなっている。これにより、流路３１は、遮断される。第２の状態では、開閉部７１が操作部材８によって強制的に開いたものとなっている。これにより、流路３１は、弁機構６の先端側の部分と基端側の部分との間が開通する。なお、第２の状態では、操作部材８の先端部（テーパ部８３）が開閉部７１の先端面から突出しているのが好ましい。 The operation member 8 is a member for opening / closing the opening / closing part 71 of the valve body 7. The operation member 8 is supported so as to be movable along the longitudinal direction of the flow path 31. As a result, in the indwelling needle 11 (valve mechanism 6), the operating member 8 is positioned on the proximal end side relative to the opening / closing part 71 (see FIGS. 2 to 4), and the operating member from the first state. The second state (see FIGS. 6 and 7) can be taken when 8 moves in the distal direction and penetrates the opening / closing part 71 to push the opening / closing part 71 open. In the first state, the opening / closing part 71 is closed by self-occlusion. Thereby, the flow path 31 is interrupted | blocked. In the second state, the opening / closing part 71 is forcibly opened by the operation member 8. As a result, the flow path 31 is opened between the distal end portion and the proximal end portion of the valve mechanism 6. In the second state, it is preferable that the distal end portion (tapered portion 83) of the operation member 8 protrudes from the distal end surface of the opening / closing portion 71.
　図１に示すように、操作部材８は、円筒体で構成された部材本体８１と、部材本体８１に固定されたシール部８２とで構成されている。 As shown in FIG. 1, the operation member 8 includes a member main body 81 formed of a cylindrical body and a seal portion 82 fixed to the member main body 81.
　部材本体８１は、両端がそれぞれ開口しており、先端開口８１１および基端開口８１２を有している。これにより、組立状態で穿刺針１２の内針４が部材本体８１および弁体７を一括して挿通することができる（図２、図３参照）。 The member body 81 is open at both ends, and has a distal end opening 811 and a proximal end opening 812. Accordingly, the inner needle 4 of the puncture needle 12 can be inserted through the member main body 81 and the valve body 7 in an assembled state (see FIGS. 2 and 3).
　部材本体８１の先端部には、その外径が先端方向に向かって漸減したテーパ状をなすテーパ部８３が形成されている。これにより、操作部材８が弁体７の開閉部７１を開く際、テーパ部８３が開閉部７１に容易に入り込むことができ、よって、開閉部７１を外方に向かって確実に押し広げることができる。 A tapered portion 83 having a tapered shape whose outer diameter gradually decreases toward the distal end is formed at the distal end of the member main body 81. Thereby, when the operating member 8 opens the opening / closing part 71 of the valve body 7, the taper part 83 can easily enter the opening / closing part 71, so that the opening / closing part 71 can be surely pushed outward. it can.
　部材本体８１の長手方向の途中、すなわち、テーパ部８３の基端側直近には、係合部８４が突出形成されている。係合部８４は、部材本体８１の周方向に沿ってリング状に形成されている。そして、図２に示すように、係合部８４は、第１の状態で外針ハブ３の縮径部３１５に係合する。これにより、操作部材８が流路３１から離脱するのを防止することができる。 An engaging portion 84 is formed to project in the middle of the member main body 81 in the longitudinal direction, that is, in the vicinity of the proximal end side of the tapered portion 83. The engaging portion 84 is formed in a ring shape along the circumferential direction of the member main body 81. As shown in FIG. 2, the engaging portion 84 engages with the reduced diameter portion 315 of the outer needle hub 3 in the first state. Thereby, it is possible to prevent the operation member 8 from being separated from the flow path 31.
　部材本体８１の基端部には、シール部８２が設置される設置部８５が形成されている。設置部８５は、部材本体８１の周方向に沿ってリング状に形成された凹部で構成されている。このような形状の設置部８５にシール部８２が挿入される。そして、後述するようにシール部８２が設置部８５に嵌合するのと相まって、部材本体８１が移動している最中であっても当該部材本体８１からシール部８２が不本意に離脱するのを確実に防止することができる。 An installation portion 85 in which the seal portion 82 is installed is formed at the base end portion of the member main body 81. The installation portion 85 is configured by a concave portion formed in a ring shape along the circumferential direction of the member main body 81. The seal portion 82 is inserted into the installation portion 85 having such a shape. As will be described later, the seal portion 82 is unintentionally detached from the member main body 81 even when the member main body 81 is moving in combination with the fitting of the seal portion 82 to the installation portion 85. Can be reliably prevented.
　また、部材本体８１の基端開口８１２の縁部には、一対の欠損部８１３が形成されている。これらの欠損部８１３は、部材本体８１の中心軸を介して互いに反対側に配置されている。このように形成された各欠損部８１３は、それぞれ、留置針組立体１にコネクタ２０を接続する際に、部材本体８１内の空気を排出する排気口として機能する。この排気により、部材本体８１内の空気の残留を防止することができる。なお、欠損部８１３の形成数は、本実施形態では２つであるが、これに限定されず、例えば、１つまたは３つ以上であってもよい。 Also, a pair of missing portions 813 are formed at the edge of the base end opening 812 of the member main body 81. These missing portions 813 are arranged on the opposite sides with respect to the central axis of the member main body 81. Each of the defect portions 813 formed in this way functions as an exhaust port for discharging the air in the member main body 81 when the connector 20 is connected to the indwelling needle assembly 1. By this exhaust, residual air in the member main body 81 can be prevented. Note that the number of missing portions 813 formed in the present embodiment is two, but is not limited thereto, and may be one or three or more, for example.
　なお、操作部材８では、欠損部８１３が省略されていてもよい。この場合、第１の状態で操作部材８と外針ハブ３との間に間隙が形成されているのが好ましい。 In the operation member 8, the missing portion 813 may be omitted. In this case, it is preferable that a gap is formed between the operation member 8 and the outer needle hub 3 in the first state.
　部材本体８１の設置部８５には、シール部８２が設置されている。このシール部８２は、外針ハブ３の流路３１内の気密性を保持することができるものである。 The seal part 82 is installed in the installation part 85 of the member main body 81. The seal portion 82 can maintain airtightness in the flow path 31 of the outer needle hub 3.
　シール部８２は、部材本体８１と別体の、弾性材料で構成されたリング状をなす部材である。シール部８２の横断面形状は、本実施形態では円形であるが、これに限定されず、例えば、四角形等のような多角形、楕円形、Ｖ字状、Ｕ字状であってもよい。 The seal portion 82 is a ring-shaped member made of an elastic material that is separate from the member main body 81. The cross-sectional shape of the seal portion 82 is circular in the present embodiment, but is not limited thereto, and may be, for example, a polygon such as a quadrangle, an ellipse, a V shape, or a U shape.
　外力を付与しない自然状態でのシール部８２の内径は、部材本体８１の設置部８５の外径と同じであってもよいが、それより若干小さいのが好ましい。シール部８２の内径が設置部８５の外径より若干小さい場合、シール部８２は、設置部８５に嵌合して、確実に固定されることとなる。 The inner diameter of the seal portion 82 in a natural state where no external force is applied may be the same as the outer diameter of the installation portion 85 of the member main body 81, but is preferably slightly smaller. When the inner diameter of the seal portion 82 is slightly smaller than the outer diameter of the installation portion 85, the seal portion 82 is fitted into the installation portion 85 and is securely fixed.
　また、自然状態でのシール部８２の外径φｄ１は、第２のテーパ部３１４の最大内径φｄ２ｍａｘと最小内径φｄ２ｍｉｎとの中間の大きさである、すなわち、第２のテーパ部３１４の最大内径φｄ２ｍａｘよりも小さく、最小内径φｄ２ｍｉｎよりも大きく設定されている（図２参照）。 The outer diameter .phi.d 1 of the seal portion 82 in a natural state is intermediate in size between the largest internal diameter .phi.d 2max and minimum inside diameter .phi.d 2min second tapered portion 314, i.e., the second tapered portion 314 smaller than the maximum inner diameter .phi.d 2max, is set larger than the minimum inner diameter .phi.d 2min (see FIG. 2).
　そして、シール部８２は、第２のテーパ部３１４が形成されている範囲内を移動することができる。図２～図４、図９に示すように、第１の状態では、シール部８２は、第２のテーパ部３１４（流路３１）の内周面３１１から離間している。これにより、シール部８２の外周面８２１と第２のテーパ部３１４の内周面３１１との間に、間隙３１７が形成される。前述したように組立状態の留置針組立体１で生体表面を穿刺して、外針２が血管を確保すると、血液Ｒが外針２の先端開口２２から流入して、当該外針２を流下してくる、すなわち、フラッシュバックが生じる（図３参照）。この流下した血液Ｒは、流路３１に流入して、当該流路３１内の空気Ｇを弁体７の各溝７３から押し出す。そして、押し出された空気Ｇは、前記間隙３１７を介して、大気中に排出される。 And the seal part 82 can move within the range where the second taper part 314 is formed. As shown in FIGS. 2 to 4 and 9, in the first state, the seal portion 82 is separated from the inner peripheral surface 311 of the second taper portion 314 (channel 31). As a result, a gap 317 is formed between the outer peripheral surface 821 of the seal portion 82 and the inner peripheral surface 311 of the second tapered portion 314. As described above, when the living body surface is punctured with the indwelling needle assembly 1 in the assembled state and the outer needle 2 secures a blood vessel, the blood R flows from the distal end opening 22 of the outer needle 2 and flows down the outer needle 2. That is, flashback occurs (see FIG. 3). The blood R that has flowed down flows into the flow path 31 and pushes out the air G in the flow path 31 from the grooves 73 of the valve body 7. The pushed air G is discharged into the atmosphere through the gap 317.
　図６、図７に示すように、第２の状態では、シール部８２は、外周面８２１が第２のテーパ部３１４の内周面３１１に密着する。これにより、流路３１内の気密性が確実に保持される。また、第２の状態では、血液Ｒは、操作部材８の部材本体８１内にも流入し、さらには欠損部８１３を介して、部材本体８１の外周部と外針ハブ３の内周面３１１との間の空間（以下「デッドスペース３１３」と言う）にも流入しそうになる。しかしながら、シール部８２によって、流路３１の一部であるデッドスペース３１３の気密性が維持されているため、当該デッドスペース３１３への血液Ｒの流入を阻止することができる。これにより、デッドスペース３１３に血液Ｒが滞留するのを防止することができ、よって、滞留した血液Ｒが細菌の増殖源となったり、血栓源となったりする不具合が生じるのを防止することができる。 As shown in FIGS. 6 and 7, in the second state, the seal portion 82 has the outer peripheral surface 821 in close contact with the inner peripheral surface 311 of the second taper portion 314. Thereby, the airtightness in the flow path 31 is reliably maintained. In the second state, the blood R also flows into the member main body 81 of the operation member 8, and further through the defect portion 813, the outer peripheral portion of the member main body 81 and the inner peripheral surface 311 of the outer needle hub 3. It is likely to flow into the space between the two (hereinafter referred to as “dead space 313”). However, since the airtightness of the dead space 313 that is a part of the flow path 31 is maintained by the seal portion 82, the blood R can be prevented from flowing into the dead space 313. Thereby, it is possible to prevent the blood R from staying in the dead space 313, and thus it is possible to prevent a problem that the staying blood R becomes a bacterial growth source or a thrombus source. it can.
　前述したように、シール部８２は、弾性を有するものである。これにより、第２の状態では、シール部８２は、部材本体８１と第２のテーパ部３１４との間で圧縮されて弾性変形する。このときシール部８２には復元力が生じるため、当該復元力によりシール部８２と第２のテーパ部３１４との密着力が増大し、流路３１（デッドスペース３１３）内の気密性がより確実に保持される。 As described above, the seal portion 82 has elasticity. Thereby, in the second state, the seal portion 82 is compressed between the member main body 81 and the second tapered portion 314 and elastically deformed. At this time, since a restoring force is generated in the seal portion 82, the adhesion force between the sealing portion 82 and the second taper portion 314 is increased by the restoring force, and the airtightness in the flow path 31 (dead space 313) is more reliable. Retained.
　また、操作部材８が先端方向に移動する際、シール部８２は第２の状態になるまで第２のテーパ部３１４から離間しているため、第２のテーパ部３１４との摺動抵抗が抑制され、よって、その移動が円滑に行なわれる。 Further, when the operation member 8 moves in the distal direction, the seal portion 82 is separated from the second taper portion 314 until it reaches the second state, so that sliding resistance with the second taper portion 314 is suppressed. Therefore, the movement is performed smoothly.
　図２、図３に示すように、穿刺針１２は、内針４と、内針４の基端部に固定された内針ハブ５とを備えている。組立状態では、外針２に内針４が挿通され、内針ハブ５の先端部が外針ハブ３の基端部に挿入、嵌合している。また、このとき、留置針１１の弁機構６が第１の状態となっており、内針４が弁体７および操作部材８を一括して挿通している。 2 and 3, the puncture needle 12 includes an inner needle 4 and an inner needle hub 5 fixed to the proximal end portion of the inner needle 4. In the assembled state, the inner needle 4 is inserted through the outer needle 2, and the distal end portion of the inner needle hub 5 is inserted and fitted into the proximal end portion of the outer needle hub 3. At this time, the valve mechanism 6 of the indwelling needle 11 is in the first state, and the inner needle 4 passes through the valve body 7 and the operation member 8 all together.
　内針４は、先端に鋭利な針先４１を有している。内針４の長さは、組立状態としたとき、少なくとも針先４１が外針２の先端開口２２から突出する程度の長さとされる。そして、この突出した針先４１により、生体表面を穿刺することができる。 The inner needle 4 has a sharp needle tip 41 at the tip. The length of the inner needle 4 is set to such a length that at least the needle tip 41 protrudes from the distal end opening 22 of the outer needle 2 when in the assembled state. The living body surface can be punctured by the protruding needle tip 41.
　内針４は、中実針であってもよいし、中空針であってもよい。内針４が中実針である場合、その外径を小さくしつつも十分な強度を確保することができる。また、内針４を中実針とすることにより、操作終了後、穿刺針１２を廃棄する際に、内針４の内部に血液が残留したり、その血液が流出するのを予防することができる。また、内針４が中空針である場合、当該内針４が血管を穿刺したときに血液が内針４の中空部に流入することにより、血液Ｒのフラッシュバックを確認することができる。また、内針４は、中空部と中実部との双方を有する構成（例えば、先端側を中空とし、基端側を中実とする構成等）とすることもできる。 The inner needle 4 may be a solid needle or a hollow needle. When the inner needle 4 is a solid needle, it is possible to ensure sufficient strength while reducing the outer diameter. Further, by making the inner needle 4 a solid needle, when the puncture needle 12 is discarded after the operation is completed, it is possible to prevent blood from remaining inside the inner needle 4 or flowing out of the blood. it can. Moreover, when the inner needle 4 is a hollow needle, when the inner needle 4 punctures a blood vessel, blood flows into the hollow portion of the inner needle 4, so that flashback of the blood R can be confirmed. Further, the inner needle 4 can be configured to have both a hollow portion and a solid portion (for example, a configuration in which the distal end side is hollow and the proximal end side is solid).
　また、内針４の先端外周部には、内針４の長手方向に沿って溝（流路）４４が凹没して形成されている。溝４４は、内針４を血管に穿刺した際に、血液Ｒを外針２の内腔２１に導入する導入路として機能する。溝４４から導入された血液Ｒは、血液が内針４と外針２との隙間に流入する（図３参照）。これにより、血液Ｒのフラッシュバックを早期から確実に確認することができる。そして、血液Ｒは、外針２の内腔２１を通過し、外針ハブ３の流路３１内に流入する。 Further, a groove (flow path) 44 is formed in a recessed manner along the longitudinal direction of the inner needle 4 in the outer peripheral portion of the tip of the inner needle 4. The groove 44 functions as an introduction path for introducing the blood R into the lumen 21 of the outer needle 2 when the inner needle 4 is punctured into the blood vessel. The blood R introduced from the groove 44 flows into the gap between the inner needle 4 and the outer needle 2 (see FIG. 3). Thereby, the flashback of blood R can be confirmed reliably from an early stage. Then, the blood R passes through the lumen 21 of the outer needle 2 and flows into the flow path 31 of the outer needle hub 3.
　また、内針４は、その外径が先端方向に向かって漸減するテーパ部を有していてもよい。 Further, the inner needle 4 may have a tapered portion whose outer diameter gradually decreases in the distal direction.
　このような内針４の構成材料としては、例えば、ステンレス鋼、アルミニウムまたはアルミニウム合金、チタンまたはチタン合金のような金属材料が挙げられる。 Examples of the constituent material of the inner needle 4 include metal materials such as stainless steel, aluminum or an aluminum alloy, titanium or a titanium alloy.
　内針４の基端部には、内針ハブ５が固定されている。また、内針ハブ５は、管状をなす部材で構成され、内針４が中空針である場合には、基端開口部にエアフィルタが設置されているのが好ましい。 The inner needle hub 5 is fixed to the proximal end portion of the inner needle 4. Further, the inner needle hub 5 is constituted by a tubular member, and when the inner needle 4 is a hollow needle, it is preferable that an air filter is installed at the proximal end opening.
　このような内針ハブ５および前述した外針ハブ３は、それぞれ、好ましくは透明（無色透明）、着色透明または半透明の樹脂で構成され、内部の視認性が確保されている。これにより、外針２が血管を確保した際、前述した内針４の溝４４を介して流入する血液Ｒのフラッシュバックを目視で確認することができる。 The inner needle hub 5 and the outer needle hub 3 described above are each preferably made of a transparent (colorless and transparent), colored transparent or translucent resin to ensure internal visibility. Thereby, when the outer needle 2 secures a blood vessel, the flashback of the blood R flowing in through the groove 44 of the inner needle 4 described above can be visually confirmed.
　外針ハブ３、内針ハブ５、操作部材８の部材本体８１の構成材料としては、特に限定されず、それぞれ、例えば、ポリエチレン、ポリプロピレン、エチレン－酢酸ビニル共重合体等のポリオレフィン、ポリウレタン、ポリアミド、ポリエステル、ポリカーボネート、ポリブタジエン、ポリ塩化ビニル等の各種樹脂材料が挙げられる。 The constituent material of the member main body 81 of the outer needle hub 3, the inner needle hub 5, and the operation member 8 is not particularly limited. For example, polyolefins such as polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyurethane, polyamide , Various resin materials such as polyester, polycarbonate, polybutadiene, and polyvinyl chloride.
　弁体７、操作部材８のシール部８２を構成する弾性材料としては、特に限定されず、例えば、天然ゴム、イソプレンゴム、ブチルゴム、ブタジエンゴム、スチレン－ブタジエンゴム、ウレタンゴム、ニトリルゴム、アクリルゴム、フッ素ゴム、シリコーンゴムのような各種ゴム材料（特に加硫処理したもの）や、ウレタン系、ポリエステル系、ポリアミド系、オレフィン系、スチレン系等の各種熱可塑性エラストマー、あるいはそれらの混合物等の各種弾性材料が挙げられ、これらの弾性材料の中でも、特に、イソプレンゴムを用いるのが好ましい。弁体７の構成材料にイソプレンゴムを用いた場合には、圧縮永久歪みが小さく、製品の使用期限が長くなるという利点がある。 The elastic material constituting the valve body 7 and the seal portion 82 of the operation member 8 is not particularly limited. For example, natural rubber, isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene rubber, urethane rubber, nitrile rubber, acrylic rubber , Various rubber materials (especially those vulcanized) such as fluoro rubber and silicone rubber, various thermoplastic elastomers such as urethane, polyester, polyamide, olefin and styrene, or mixtures thereof Examples thereof include elastic materials, and among these elastic materials, it is particularly preferable to use isoprene rubber. When isoprene rubber is used as the constituent material of the valve body 7, there is an advantage that the compression set is small and the expiration date of the product becomes long.
　次に、留置針組立体１の使用状態について説明する。
　［１］　図２に示すように、留置針組立体１は、組立状態となっている。 Next, the use state of the indwelling needle assembly 1 will be described.
[1] As shown in FIG. 2, the indwelling needle assembly 1 is in an assembled state.
　また、コネクタ２０には、輸液剤Ｑが充填された輸液バッグが予め接続されており、輸液剤Ｑの供給が可能となっている。 In addition, an infusion bag filled with the infusion agent Q is connected to the connector 20 in advance, so that the infusion agent Q can be supplied.
　［２］　次に、組立状態の留置針組立体１を把持し、患者の血管を穿刺する。外針２により血管が確保されると、血圧により血液Ｒが、内針４の溝４４を介して外針２の内腔２１を基端方向へ流入するので、視認性を有する外針２または外針ハブ３において、これを確認することができる（図３参照）。そして、このフラッシュバックを確認した後、さらに、留置針組立体１を微小距離先端方向へ進める。 [2] Next, the indwelling needle assembly 1 in an assembled state is grasped, and the patient's blood vessel is punctured. When a blood vessel is secured by the outer needle 2, the blood R flows into the proximal direction of the lumen 21 of the outer needle 2 through the groove 44 of the inner needle 4 due to blood pressure. This can be confirmed in the outer needle hub 3 (see FIG. 3). After confirming this flashback, the indwelling needle assembly 1 is further advanced toward the distal end by a minute distance.
　また、図３に示すように、流入した血液Ｒは、前述したように流路３１内の空気Ｇを弁体７の各溝７３を介して排出することができるため、流路３１の弁体７が位置するところまで到達する。 Further, as shown in FIG. 3, the blood R that has flowed in can discharge the air G in the flow path 31 through the grooves 73 of the valve body 7 as described above. It reaches where 7 is located.
　［３］　外針２により血管が確保されたら、外針２または外針ハブ３を一方の手で固定し、他方の手で内針ハブ５を把持して基端方向へ引っ張り、内針４を外針２から抜去する（図４参照）。これにより、留置針組立体１は、抜去状態となる。このとき、留置針１１では、弁体７が自己閉塞性により閉状態となっているため、流路３１内の血液Ｒが外部へ漏出するのが防止されている。また、抜去された穿刺針１２は、不用となるため、廃棄処分に供される。 [3] When a blood vessel is secured by the outer needle 2, the outer needle 2 or the outer needle hub 3 is fixed with one hand, and the inner needle hub 5 is grasped with the other hand and pulled toward the proximal end. Is removed from the outer needle 2 (see FIG. 4). Thereby, the indwelling needle assembly 1 will be in an extraction state. At this time, in the indwelling needle 11, since the valve body 7 is closed due to self-occlusion, the blood R in the flow path 31 is prevented from leaking to the outside. Moreover, since the extracted puncture needle 12 becomes unnecessary, it is subjected to disposal.
　［４］　次に、留置針１１の外針ハブ３を粘着テープ等により皮膚に固定する。そして、外針ハブ３にコネクタ２０を接続する（図５、図６参照）。この接続により、操作部材８は、コネクタ２０で押圧されて先端方向に移動し、弁体７を押し開く。これにより、留置針１１は、第２の状態となる。なお、第２の状態となるまでは、すなわち、血液Ｒが操作部材８の部材本体８１内に入り始める直前までは、シール部８２は、外針ハブ３の内周面３１１と接触していない（図５参照）。 [4] Next, the outer needle hub 3 of the indwelling needle 11 is fixed to the skin with an adhesive tape or the like. Then, the connector 20 is connected to the outer needle hub 3 (see FIGS. 5 and 6). By this connection, the operation member 8 is pressed by the connector 20 and moves in the distal direction, and pushes the valve body 7 open. Thereby, the indwelling needle 11 will be in a 2nd state. Note that the seal portion 82 is not in contact with the inner peripheral surface 311 of the outer needle hub 3 until the second state is reached, that is, until immediately before the blood R starts to enter the member main body 81 of the operation member 8. (See FIG. 5).
　［５］　次に、輸液剤Ｑの供給を開始する。これにより、輸液剤Ｑは、血液Ｒを先端方向に押し出しつつ、コネクタ２０内、操作部材８の部材本体８１内、外針２内を順に通過し、患者に投与される（図７参照）。 [5] Next, supply of the infusion solution Q is started. Thereby, the infusion agent Q passes through the connector 20, the member main body 81 of the operation member 8, and the outer needle 2 in order while pushing the blood R in the distal direction, and is administered to the patient (see FIG. 7).
　［６］輸液剤Ｑの投与が完了したら、コネクタ２０を留置針１１から取り外す（図８参照）。 [6] When administration of the infusion Q is completed, the connector 20 is removed from the indwelling needle 11 (see FIG. 8).
　また、第２の状態では、操作部材８のテーパ部８３が弁体７の開閉部７１を貫通しているため、この開閉部７１によって、テーパ部８３に対し基端方向への付勢力が作用している。そして、コネクタ２０を留置針１１から取り外す操作を行なうと、当該コネクタ２０による操作部材８への押圧力が解除されることとなり、操作部材８は、開閉部７１の前記付勢力により基端方向へ移動する。これにより、留置針１１が第１の状態に戻り、すなわち、開閉部７１が閉じ、よって、留置針１１内の輸液剤Ｑの漏れが防止される（図９参照）。 In the second state, the taper portion 83 of the operating member 8 penetrates the opening / closing portion 71 of the valve body 7, so that the biasing force in the proximal direction acts on the taper portion 83 by the opening / closing portion 71. is doing. When the connector 20 is removed from the indwelling needle 11, the pressing force applied to the operation member 8 by the connector 20 is released, and the operation member 8 is moved in the proximal direction by the urging force of the opening / closing portion 71. Moving. Thereby, the indwelling needle 11 returns to the first state, that is, the opening / closing part 71 is closed, and thus the infusion agent Q in the indwelling needle 11 is prevented from leaking (see FIG. 9).
　＜第２実施形態＞
  図１０は、本発明の接続具を留置針に適用した場合の第２実施形態における操作部材の縦断面図である。なお、以下では、説明の都合上、図１０中の右側を「基端」、左側を「先端」と言う。 Second Embodiment
FIG. 10 is a longitudinal sectional view of an operating member in the second embodiment when the connector of the present invention is applied to an indwelling needle. In the following, for convenience of explanation, the right side in FIG. 10 is referred to as “base end” and the left side is referred to as “tip”.
　以下、この図を参照して本発明の接続具および留置針組立体の第２実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the second embodiment of the connector and the indwelling needle assembly of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do.
　本実施形態は、シール部の構成が異なること以外は前記第１実施形態と同様である。
　図１０に示すように、操作部材８Ａでは、シール部８２Ａは、部材本体８１の基端外周部に一体的に形成されている。このシール部８２Ａは、部材本体８１の基端外周部の周方向に沿ってリング状に突出した突部、すなわち、部材本体８１の基端外周部の外径が拡径して形成されたフランジで構成されている。 The present embodiment is the same as the first embodiment except that the configuration of the seal portion is different.
As shown in FIG. 10, in the operation member 8 </ b> A, the seal portion 82 </ b> A is formed integrally with the proximal end outer peripheral portion of the member main body 81. The seal portion 82A is a protrusion that protrudes in a ring shape along the circumferential direction of the base end outer peripheral portion of the member main body 81, that is, a flange formed by expanding the outer diameter of the base end outer peripheral portion of the member main body 81. It consists of
　このように部材本体８１とシール部８２Ａとが一体的に形成されていることにより、操作部材８Ａを構成する部品点数を抑えることができる。また、操作部材８Ａを例えば金型成形で容易に製造することができる。 As described above, since the member main body 81 and the seal portion 82A are integrally formed, the number of parts constituting the operation member 8A can be suppressed. Further, the operation member 8A can be easily manufactured, for example, by molding.
　＜第３実施形態＞
  図１１は、本発明の接続具を留置針に適用した場合の第３実施形態を示す縦断面図である。なお、以下では、説明の都合上、図１１中の右側を「基端」、左側を「先端」と言う。 <Third Embodiment>
FIG. 11 is a longitudinal sectional view showing a third embodiment when the connector of the present invention is applied to an indwelling needle. In the following, for convenience of explanation, the right side in FIG. 11 is referred to as “base end” and the left side is referred to as “tip”.
　以下、この図を参照して本発明の接続具および留置針組立体の第３実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the third embodiment of the connector and the indwelling needle assembly of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do.
　本実施形態は、シール部の設置位置が異なること以外は前記第１実施形態と同様である。 This embodiment is the same as the first embodiment except that the installation position of the seal portion is different.
　図１１に示すように、外針ハブ３Ａにシール部３３が配置されている。シール部３３は、弾性材料で構成されたリング状をなす部材である。シール部３３の横断面形状は、本実施形態では円形であるが、これに限定されず、例えば、四角形等のような多角形、楕円形、Ｖ字状、Ｕ字状であってもよい。 As shown in FIG. 11, a seal portion 33 is disposed on the outer needle hub 3A. The seal portion 33 is a ring-shaped member made of an elastic material. The cross-sectional shape of the seal portion 33 is circular in the present embodiment, but is not limited thereto, and may be, for example, a polygon such as a quadrangle, an ellipse, a V shape, or a U shape.
　また、流路３１の縮径部３１５よりも基端側の部分には、その内周面３１１に周方向に沿ったリング状の凹部３１８が形成されている。この凹部３１８にシール部３３が挿入、設置されている。 Further, a ring-shaped recess 318 is formed on the inner peripheral surface 311 of the flow path 31 on the proximal end side of the reduced diameter portion 315 along the circumferential direction. The seal portion 33 is inserted and installed in the recess 318.
　このように設けられたシール部３３は、図１１示す第２の状態で、外周面３３１が操作部材８の外周部８１４に密着する。これにより、流路３１内の気密性が確実に保持され、よって、デッドスペース３１３への輸液剤Ｑや血液Ｒの流入を阻止することができる。 In the second state shown in FIG. 11, the outer peripheral surface 331 of the seal portion 33 provided in this manner is in close contact with the outer peripheral portion 814 of the operation member 8. Thereby, the airtightness in the flow path 31 is reliably maintained, so that the infusion of the infusion agent Q and the blood R into the dead space 313 can be prevented.
　以上、本発明の接続具および留置針組立体を図示の実施形態について説明したが、本発明は、これに限定されるものではなく、接続具および留置針組立体を構成する各部は、同様の機能を発揮し得る任意の構成のものと置換することができる。また、任意の構成物が付加されていてもよい。 As mentioned above, although the connection tool and indwelling needle assembly of this invention were demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises a connection tool and an indwelling needle assembly is the same. It can be replaced with any structure that can perform its function. Moreover, arbitrary components may be added.
　また、本発明の留置針組立体（接続具）は、血管内に挿入して使用されるものの他に、例えば、腹腔内、胸腔内、リンパ管内、脊柱管内等に挿入して使用されるものにも適用することもできる。 The indwelling needle assembly (connector) of the present invention is used by being inserted into a blood vessel, for example, inserted into an abdominal cavity, thoracic cavity, lymphatic vessel, spinal canal, etc. It can also be applied to.
　また、弁体は、図示の構成ものに限定されず、例えば、ダックビル弁で構成されたものであってもよい。 Further, the valve body is not limited to the one shown in the figure, and may be one constituted by, for example, a duckbill valve.
　また、シール部は、前記第１実施形態および前記第２実施形態では第２の状態で外針ハブのテーパ状をなす部分に密着するよう構成されているが、これに限定されず、例えば、外針ハブの内周面にその周方向に沿ってリング状に突出する突部を形成し、当該突部に密着するよう構成されていてもよい。 Further, in the first embodiment and the second embodiment, the seal portion is configured to be in close contact with the tapered portion of the outer needle hub in the second state, but is not limited thereto, for example, A protrusion protruding in a ring shape along the circumferential direction may be formed on the inner peripheral surface of the outer needle hub, and the outer needle hub may be configured to be in close contact with the protrusion.
　本発明の接続具は、中空の外針と、外針の基端部に設けられ、外針内と連通する流路を有し、流路に基端側から管体を接続可能なハブと、流路を遮断・開放する弁機構とを備え、弁機構は、流路の途中に設けられ、弾性材料で構成された開閉可能な開閉部を有する弁体と、流路の長手方向に沿って移動可能に支持され、開閉部を開閉操作する操作部材とを有し、開閉部が閉じ、開閉部よりも操作部材が基端側に位置する第１の状態と、第１の状態から流路に管体を接続した際に、管体で操作部材が押圧されて先端方向に移動し開閉部を押し開く第２の状態とを取り得、第２の状態で流路内の気密性を保持するシール部を有する。そのため、第２の状態でハブの流路の内周面に操作部材のシール部が密着して当該流路内の気密性が確実に保持される。この状態でフラッシュバックにより血液が流路内に流入した際には、当該血液は、流路の死角でもある、操作部材とハブとの間の空間にも流入しようとする。しかしながら、シール部によって、流路の一部である前記空間の気密性が維持されているため、この空間への血液の流入を阻止することができる。これにより、前記空間に血液が滞留するのを防止することができ、よって、滞留した血液が細菌の増殖源となったり、血栓源となったりする不具合が生じるのを防止することができる。従って、本発明の接続具は、産業上の利用可能性を有する。 The connector of the present invention includes a hollow outer needle, a hub provided at a proximal end portion of the outer needle, having a flow channel communicating with the inside of the outer needle, and capable of connecting a tubular body to the flow channel from the proximal end side. A valve mechanism that shuts off / opens the flow path, and the valve mechanism is provided in the middle of the flow path and has an openable / closable opening / closing portion made of an elastic material, along the longitudinal direction of the flow path And an operating member that opens and closes the opening / closing part, the opening / closing part is closed, and the operating member is located closer to the proximal end than the opening / closing part, and the first state When the pipe body is connected to the road, the operation member is pressed by the pipe body and can move to the distal end direction to push the opening / closing part, and the airtightness in the flow path is maintained in the second state. A sealing portion. Therefore, in the second state, the seal portion of the operating member is in close contact with the inner peripheral surface of the flow path of the hub, and the airtightness in the flow path is reliably maintained. When blood flows into the flow path by flashback in this state, the blood tends to flow into the space between the operating member and the hub, which is also the blind spot of the flow path. However, since the airtightness of the space that is a part of the flow path is maintained by the seal portion, it is possible to prevent blood from flowing into the space. Thereby, it is possible to prevent blood from staying in the space, and thus it is possible to prevent a problem that the staying blood becomes a bacterial growth source or a thrombus source. Therefore, the connection tool of the present invention has industrial applicability.

Claims (11)

  1. 　中空の外針と、
    　前記外針の基端部に設けられ、該外針内と連通する流路を有し、該流路に基端側から管体を接続可能なハブと、
    　前記流路を遮断・開放する弁機構とを備え、
    　前記弁機構は、前記流路の途中に設けられ、弾性材料で構成された開閉可能な開閉部を有する弁体と、前記流路の長手方向に沿って移動可能に支持され、前記開閉部を開閉操作する操作部材とを有し、前記開閉部が閉じ、該開閉部よりも前記操作部材が基端側に位置する第１の状態と、前記第１の状態から前記流路に前記管体を接続した際に、該管体で前記操作部材が押圧されて先端方向に移動し前記開閉部を押し開く第２の状態とを取り得、
    　前記第２の状態で前記流路内の気密性を保持するシール部を有することを特徴とする接続具。     A hollow outer needle,
    A hub provided at a base end portion of the outer needle, having a flow channel communicating with the inside of the outer needle, and capable of connecting a tubular body to the flow channel from the base end side;
    A valve mechanism for blocking and opening the flow path,
    The valve mechanism is provided in the middle of the flow path, and has a valve body having an openable / closable opening / closing part made of an elastic material, and is supported so as to be movable along the longitudinal direction of the flow path. A first state in which the opening / closing part is closed and the operation member is located on a proximal end side relative to the opening / closing part, and the pipe body from the first state to the flow path. When the operation member is pressed by the tube body, the second member moves in the distal direction and pushes the opening / closing part open.
    A connector having a seal portion for maintaining airtightness in the flow path in the second state.
  2. 　前記シール部は、前記操作部材の外周部に設けられ、前記第２の状態で前記流路の内周面に密着して前記流路内の気密性を保持するものである請求項１に記載の接続具。 The said seal part is provided in the outer peripheral part of the said operation member, closely_contact | adheres to the internal peripheral surface of the said flow path in the said 2nd state, and maintains the airtightness in the said flow path. Connection tool.
  3. 　前記流路は、その内周面に内径が先端方向に向かって漸減するテーパ状をなすテーパ部を有し、
    　前記シール部は、リング状をなし、その外径が前記テーパ部の最大内径よりも小さく、最小内径よりも大きいものであり、前記第１の状態および前記第２の状態のいずれの状態で前記テーパ部に位置している請求項２に記載の接続具。     The flow path has a tapered portion having a tapered shape in which an inner diameter gradually decreases in a tip direction on an inner peripheral surface thereof,
    The seal portion has a ring shape, and an outer diameter thereof is smaller than a maximum inner diameter of the taper portion and larger than a minimum inner diameter, and the seal portion is in any of the first state and the second state. The connector according to claim 2, wherein the connector is located at the tapered portion.
  4. 　前記操作部材は、両端がそれぞれ開口した筒体で構成された部材本体を有し、
    　前記シール部は、前記部材本体と別体のリング状をなす部材で構成され、前記部材本体の外周部に嵌合により固定されている請求項２に記載の接続具。     The operation member has a member body composed of a cylindrical body having both ends opened,
    The connector according to claim 2, wherein the seal portion is configured by a member that forms a ring shape that is separate from the member main body, and is fixed to the outer peripheral portion of the member main body by fitting.
  5. 　前記操作部材は、両端がそれぞれ開口した筒体で構成された部材本体を有し、
    　前記シール部は、前記部材本体の外周部に一体的に形成され、該外周部の周方向に沿ってリング状に突出した突部で構成されている請求項２に記載の接続具。     The operation member has a member body composed of a cylindrical body having both ends opened,
    The connector according to claim 2, wherein the seal portion is formed integrally with an outer peripheral portion of the member main body, and includes a protrusion protruding in a ring shape along a circumferential direction of the outer peripheral portion.
  6. 　前記第１の状態では、前記流路の内周面と前記シール部との間に間隙が形成されており、該間隙を介して、前記流路内の空気を排出可能である請求項２に記載の接続具。 3. In the first state, a gap is formed between the inner peripheral surface of the flow path and the seal portion, and the air in the flow path can be discharged through the gap. The connector as described.
  7. 　前記シール部は、前記流路の内周面に設けられ、前記第２の状態で前記操作部材の外周部に密着して前記流路内の気密性を保持するものである請求項１に記載の接続具。 The said seal | sticker part is provided in the inner peripheral surface of the said flow path, and adhere | attaches the outer peripheral part of the said operation member in the said 2nd state, and maintains the airtightness in the said flow path. Connection tool.
  8. 　前記弁体は、前記第２の状態で前記操作部材を基端方向に向かって付勢する機能を有する請求項１に記載の接続具。 The connector according to claim 1, wherein the valve body has a function of urging the operation member toward the proximal direction in the second state.
  9. 　前記開閉部は、板状部と、該板状部の厚さ方向に貫通して形成された貫通孔とで構成されている請求項１に記載の接続具。 The connecting device according to claim 1, wherein the opening / closing portion includes a plate-like portion and a through-hole formed so as to penetrate in the thickness direction of the plate-like portion.
  10. 　前記板状部には、その外周部に厚さ方向に沿って溝が少なくとも１本形成されている請求項９に記載の接続具。 10. The connector according to claim 9, wherein at least one groove is formed in the outer periphery of the plate-like portion along the thickness direction.
  11. 　請求項１に記載の接続具と、
    　前記第１の状態で前記外針に挿通される内針とを備えることを特徴とする留置針組立体。     The connector according to claim 1;
    An indwelling needle assembly comprising: an inner needle that is inserted through the outer needle in the first state.
PCT/JP2011/058695 2010-06-30 2011-04-06 Connection tool and indwelling needle assembly WO2012002015A1 (en)

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US9114241B2 (en) 2009-02-11 2015-08-25 Becton, Dickinson And Company Systems and methods for providing a flushable catheter assembly
US9155876B2 (en) 2011-10-06 2015-10-13 Becton, Dickinson And Company Port valve of a blood control catheter
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