WO2012002015A1 - Outil de raccord et ensemble aiguille placée à demeure - Google Patents

Outil de raccord et ensemble aiguille placée à demeure 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
English (en)
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/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention se rapporte à un outil de raccord qui est pourvu d'une aiguille creuse ; d'un moyeu qui est monté sur une partie proximale d'une aiguille externe, qui comprend un canal en liaison avec l'aiguille externe et pour lequel un tuyau peut être raccordé au canal depuis la partie proximale ; et d'un mécanisme de soupape pour bloquer et ouvrir le canal, le mécanisme de soupape comprenant un corps de soupape qui est agencé au milieu du canal et qui présente une partie ouvrante qui peut être fermée, construite avec un matériau élastique, et un élément de fonctionnement qui est supporté de sorte à être mobile le long de la direction longitudinale du canal pour effectuer des opérations d'ouverture et de fermeture de la partie ouvrante. L'outil de raccord peut avoir un premier état dans lequel la partie ouvrante est fermée et l'élément de fonctionnement est positionné davantage vers le côté proximal que vers la partie ouvrante ; ou un second état dans lequel, lorsque le tuyau est raccordé au canal dans le premier état, l'élément de fonctionnement est pressé avec le tuyau de sorte à se déplacer dans la direction d'extrémité pour pousser et ouvrir la section ouvrante. L'outil de raccord comprend une partie d'étanchéité pour maintenir une étanchéité à l'air à l'intérieur du canal dans le second état.
PCT/JP2011/058695 2010-06-30 2011-04-06 Outil de raccord et ensemble aiguille placée à demeure WO2012002015A1 (fr)

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JP2010150078 2010-06-30

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Cited By (9)

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WO2013052656A1 (fr) * 2011-10-06 2013-04-11 Becton, Dickinson And Company Systèmes et procédés pour étanchéifier un septum dans un dispositif de cathéter
WO2013137348A1 (fr) * 2012-03-16 2013-09-19 テルモ株式会社 Ensemble cathéter
US9114241B2 (en) 2009-02-11 2015-08-25 Becton, Dickinson And Company Systems and methods for providing a flushable catheter assembly
US9126012B2 (en) 2011-10-06 2015-09-08 Becton, Dickinson And Company Intravenous catheter with duckbill valve
US9155863B2 (en) 2011-10-06 2015-10-13 Becton, Dickinson And Company Multiple use stretching and non-penetrating blood control valves
US9155876B2 (en) 2011-10-06 2015-10-13 Becton, Dickinson And Company Port valve of a blood control catheter
US9358364B2 (en) 2011-10-06 2016-06-07 Becton, Dickinson And Company Activator attachment for blood control catheters
US9750925B2 (en) 2014-01-21 2017-09-05 Becton, Dickinson And Company Ported catheter adapter having combined port and blood control valve with venting
EP4275721A1 (fr) * 2022-05-11 2023-11-15 Inductio AG Seringue médicale

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JP2002263197A (ja) * 2001-03-12 2002-09-17 Medikit Kk 留置用カテーテル
JP2004242762A (ja) * 2003-02-12 2004-09-02 Nipro Corp 留置用カテーテル

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002263197A (ja) * 2001-03-12 2002-09-17 Medikit Kk 留置用カテーテル
JP2004242762A (ja) * 2003-02-12 2004-09-02 Nipro Corp 留置用カテーテル

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US9089671B2 (en) 2011-10-06 2015-07-28 Becton, Dickinson And Company Systems and methods for sealing a septum within a catheter device
US9126012B2 (en) 2011-10-06 2015-09-08 Becton, Dickinson And Company Intravenous catheter with duckbill valve
US9155863B2 (en) 2011-10-06 2015-10-13 Becton, Dickinson And Company Multiple use stretching and non-penetrating blood control valves
WO2013052656A1 (fr) * 2011-10-06 2013-04-11 Becton, Dickinson And Company Systèmes et procédés pour étanchéifier un septum dans un dispositif de cathéter
US9358364B2 (en) 2011-10-06 2016-06-07 Becton, Dickinson And Company Activator attachment for blood control catheters
US10118017B2 (en) 2011-10-06 2018-11-06 Becton, Dickinson And Company Activator attachment for blood control catheters
US11135399B2 (en) 2011-10-06 2021-10-05 Becton, Dickinson And Company Activator attachment for blood control catheters
WO2013137348A1 (fr) * 2012-03-16 2013-09-19 テルモ株式会社 Ensemble cathéter
US9750925B2 (en) 2014-01-21 2017-09-05 Becton, Dickinson And Company Ported catheter adapter having combined port and blood control valve with venting
US10543351B2 (en) 2014-01-21 2020-01-28 Becton, Dickinson And Company Ported catheter adapter having combined port and blood control valve with venting
EP4275721A1 (fr) * 2022-05-11 2023-11-15 Inductio AG Seringue médicale
WO2023217973A1 (fr) * 2022-05-11 2023-11-16 Inductio Ag Seringue médicale

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