WO2021095808A1 - Catheter assembly - Google Patents

Catheter assembly Download PDF

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Publication number
WO2021095808A1
WO2021095808A1 PCT/JP2020/042277 JP2020042277W WO2021095808A1 WO 2021095808 A1 WO2021095808 A1 WO 2021095808A1 JP 2020042277 W JP2020042277 W JP 2020042277W WO 2021095808 A1 WO2021095808 A1 WO 2021095808A1
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WO
WIPO (PCT)
Prior art keywords
catheter
hub
inner needle
arrow
grip
Prior art date
Application number
PCT/JP2020/042277
Other languages
French (fr)
Japanese (ja)
Inventor
石田昌弘
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
Priority to JP2021556149A priority Critical patent/JPWO2021095808A1/ja
Publication of WO2021095808A1 publication Critical patent/WO2021095808A1/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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like

Definitions

  • the present invention relates to a catheter assembly having a safety member for preventing accidental puncture of an inner needle.
  • a catheter assembly as disclosed in Japanese Patent Publication No. 2013-529111 is used.
  • This catheter assembly has a multi-tube with an inner needle inserted through a catheter (outer needle).
  • the user punctures a multi-tube into the patient's body, then allows the catheter to enter the blood vessel, and further removes the internal needle from the catheter to place the catheter.
  • the catheter assembly disclosed in Japanese Patent Application Laid-Open No. 2013-529111 moves with the catheter operating member for advancing and retreating the catheter and the catheter hub, and the needle tip of the internal needle by following the advancing and retreating of the catheter operating member. It has a safety member that activates the function of preventing accidental puncture of the inner needle by covering it.
  • the safety member is made to follow by engaging the safety member with the catheter hub or the catheter operating member to prevent accidental puncture. It is configured to disengage as the function is activated. Therefore, in the catheter assembly, the engagement structure between the catheter, the catheter hub, the inner needle, the safety member, and the catheter operating member tends to be complicated, and the assembling work of each member is troublesome.
  • the present invention relates to the above-mentioned technique of a catheter assembly, and an object of the present invention is to provide a catheter assembly capable of simplifying the assembly of each member and greatly improving work efficiency.
  • one aspect of the present invention is for a user to operate a catheter, a catheter hub for holding the catheter, an internal needle inserted through the catheter, the catheter and the movement of the catheter hub. It can be moved together with the catheter hub by being inserted into the catheter hub and fitted with the catheter operating member for the purpose of moving, and the inner needle advances beyond the tip of the inner needle pierced by the treatment target.
  • a catheter assembly including a safety member that activates an erroneous puncture prevention function, wherein the catheter operating member extends in an axial direction of a tubular portion having an insertion space into which the safety member is inserted and an insertion space. It has a slit, which allows the inner needle to pass from the side of the tubular portion to the insertion space, while allowing the safety member to pass from the insertion space to the side of the tubular portion. Make it impossible.
  • the above catheter assembly simplifies the assembly of each member and can greatly improve work efficiency.
  • FIG. 3A is a first operation diagram showing a procedure when using the catheter assembly.
  • FIG. 3B is a second operation diagram showing a procedure when using the catheter assembly.
  • FIG. 4A is a third operation diagram showing a procedure when using the catheter assembly.
  • FIG. 4B is a fourth operation diagram showing a procedure when using the catheter assembly.
  • FIG. 6A is a perspective view of the inner needle hub that supports the inner needle as viewed from below.
  • FIG. 6B is a front view of the inner needle hub that supports the inner needle.
  • FIG. 7A is a perspective view of the safety member as viewed from below.
  • FIG. 7B is a perspective view showing a state in which the cover body covers the inner needle. It is a perspective view which looked at the state which attached the catheter operation member to a catheter hub and a cover body from the lower side. It is a perspective view which looked at the upper grip from the lower side. It is a perspective view which shows the lower grip. It is explanatory drawing explaining the fixing of the inner needle hub and the lower grip.
  • FIG. 5 is a cross-sectional view taken along the line XII-XII of FIG.
  • FIG. 13A is a perspective view showing a state before assembling the lower grip and the lower support member.
  • FIG. 13B is a perspective view showing an assembled state of the lower grip and the lower support member.
  • FIG. 19A is a perspective view schematically showing a disassembled state of the catheter assembly according to the modified example.
  • FIG. 19B is a cross-sectional view of the catheter assembly of FIG. 19A in a direction orthogonal to the longitudinal direction.
  • the catheter assembly 10 is used when infusing, transfusing, or collecting blood to a treatment target (living body), and the catheter 12 is inserted into the treatment target and the catheter 12 is inserted into the body of the treatment target. Indwell to make the inside and outside of the body conductive.
  • the catheter assembly 10 allows the insertion of a catheter 12 (eg, central venous catheter, PICC, midline catheter, etc.) that is longer than the peripheral venous catheter.
  • the catheter assembly 10 may have a configuration in which a peripheral venous catheter can be inserted. Further, the catheter assembly 10 is not limited to the intravenous catheter, and may be one into which an arterial catheter such as a peripheral arterial catheter is inserted.
  • the catheter assembly 10 has a catheter 12, an inner needle 14, a catheter hub 20, an inner needle hub 30, a safety member 40, and a catheter operating member 60 in a state before use (before puncture).
  • the inner / outer needle assembly 16 is provided.
  • the catheter assembly 10 accommodates the inner / outer needle assembly 16 and includes a grip 18 (housing) for the user to grip.
  • the inner needle 14 penetrates the inside of the catheter 12 and the catheter hub 20, and the needle tip 15 of the inner needle 14 forms a multi-tube 11 protruding from the tip of the catheter 12.
  • a safety member 40 through which the inner needle 14 is inserted is arranged on the proximal end side of the catheter hub 20, and an inner needle hub 30 holding the inner needle 14 is arranged on the proximal end side of the safety member 40.
  • the catheter operating member 60 is arranged above the catheter 12, the catheter hub 20, and the safety member 40, and these members can move forward and backward.
  • the inner / outer needle assembly 16 including the proximal end side portion of the multiple tube 11 is housed in the grip 18, and the inner needle hub 30 is fixed to the grip 18.
  • the operation of the catheter assembly 10 when it is used will be described first.
  • a user such as a doctor or a nurse grasps the grip 18 of the catheter assembly 10 in the pre-puncture state shown in FIG. 3A, and holds the catheter 12 and the internal needle 14 to the blood vessel (vein or artery) of the patient (treatment target).
  • the user advances the catheter 12 and the catheter hub 20 by relatively advancing the catheter operating member 60 with respect to the grip 18 (including the inner needle hub 30).
  • the catheter 12 enters the back of the blood vessel.
  • the safety member 40 also moves integrally with the movement of the catheter 12 and the catheter hub 20.
  • the catheter 12 and the catheter hub 20 are pulled out from the tip of the grip 18 by the above-mentioned advance operation, and then the safety member 40 is projected from the tip of the grip 18.
  • the catheter operating member 60 catheter 12, catheter hub 20
  • the user may perform an operation of retracting the grip 18 relative to the catheter operating member 60.
  • the base end portion of the safety member 40 moves to the movement limit (advance position) of the grip 18.
  • the safety member 40 activates the erroneous puncture prevention function by exposing the tip of the safety member 40 from the grip 18 and advancing beyond the tip of the inner needle 14 to cover the inner needle 14.
  • the safety member 40 is in a locked state in which movement in the distal end direction and the proximal end direction is stopped without coming out of the grip 18.
  • the safety member 40 is separated from these members.
  • the catheter operating member 60 and the safety member 40 are separated from each other, so that the catheter operating member 60 and the catheter hub 20 can be disengaged from each other. Therefore, the catheter 12 and the catheter hub 20 are separated from the lower part of the catheter operating member 60.
  • the catheter 12 and the catheter hub 20 are placed in the treatment target in a form detached from the catheter operating member 60.
  • the valve member 22 of the catheter hub 20 Prior to indwelling, the valve member 22 of the catheter hub 20 is removed and a connector (not shown) of another medical device is connected.
  • the inner needle 14, the inner needle hub 30, the safety member 40, and the grip 18 are appropriately discarded by the user while being integrated.
  • each configuration of the catheter assembly 10 that carries out the above operation will be specifically described.
  • the catheter 12 of the catheter assembly 10 is formed of a tubular body having appropriate flexibility.
  • a lumen 12a penetrating in the direction of arrow A (axial direction) is provided inside the catheter 12.
  • the inner cavity 12a is set to a diameter capable of accommodating the inner needle 14 and allowing the drug solution, blood, and the like to flow.
  • the length of the catheter 12 can be appropriately designed according to the application, various conditions, etc., and is set to, for example, about 14 to 500 mm, preferably within the range of 30 to 400 mm, and more preferably in the range of 76 to 200 mm. Set in.
  • a soft resin material is preferable as the constituent material of the catheter 12, and for example, a fluororesin such as polytetrafluoroethylene (PTFE), ethylene / tetrafluoroethylene copolymer (ETFE), perfluoroalkoxy alkane resin (PFA), etc.
  • a fluororesin such as polytetrafluoroethylene (PTFE), ethylene / tetrafluoroethylene copolymer (ETFE), perfluoroalkoxy alkane resin (PFA), etc.
  • PTFE polytetrafluoroethylene
  • ETFE ethylene / tetrafluoroethylene copolymer
  • PFA perfluoroalkoxy alkane resin
  • olefin resins such as polyethylene and polypropylene or mixtures thereof, polyurethanes, polyesters, polyamides, polyether nylon resins, and mixtures of olefin resins with ethylene / vinyl acetate copolymers.
  • the outer peripheral surface of the catheter 12 is coated with a coating material 13 that reduces the insertion resistance (penetration resistance) of the catheter 12 with respect to the treatment target.
  • a coating material 13 that reduces the insertion resistance (penetration resistance) of the catheter 12 with respect to the treatment target.
  • the coating material 13 is applied to the entire circumferential direction of the catheter 12 and to 2/3 or more of the total length of the catheter 12 from the tip end side to the proximal end side (arrow A2 side) of the catheter 12.
  • the coating material 13 is also applied to the needle tip 15 of the inner needle 14 exposed from the tip of the catheter 12.
  • the coating material 13 may be applied to the inner peripheral surface forming the lumen 12a of the catheter 12, or may be applied to the outer peripheral surface of the inner needle 14.
  • the material constituting the coating material 13 is not particularly limited as long as it can improve the lubricity of the catheter 12, and for example, silicone, maleic anhydride-based polymer, acrylic acid-based polymer, and sulfobetaine-based material that can reduce frictional resistance. A material such as a polymer may be applied. Further, the catheter assembly 10 can be coated with a material that enhances hydrophilicity, water repellency, antibacterial property or antithrombotic property as the coating material 13.
  • the base end portion of the catheter 12 is fixed to the tip end portion in the catheter hub 20 by an appropriate fixing means such as caulking, fusion, and adhesion.
  • the catheter hub 20 is exposed on the skin of the treatment target with the catheter 12 inserted into the blood vessel of the treatment target, and is attached with tape or the like and placed together with the catheter 12.
  • the catheter hub 20 is formed in a tubular shape that tapers toward the arrow A1 side (tip direction). Flange portions 21 projecting outward in the radial direction are continuously provided on the outer peripheral surface of the catheter hub 20 on the proximal end side. The flange portion 21 has a spiral shape that can be screwed into other medical devices. Further, inside the catheter hub 20, an internal space 20a is provided which communicates with the lumen 12a of the catheter 12 and allows the drug solution and blood to flow. The proximal end of the internal space 20a communicates with the proximal end opening 20a1 of the catheter hub 20.
  • the constituent material of the catheter hub 20 is not particularly limited, but for example, a thermoplastic resin such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, and a methacrylate / butylene / styrene copolymer may be applied.
  • a thermoplastic resin such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, and a methacrylate / butylene / styrene copolymer may be applied.
  • a valve member 22 is inserted into the catheter hub 20 from the base end opening 20a1 toward the back side (arrow A1 side) of the internal space 20a.
  • the valve member 22 has an insertion portion 23 that is inserted into the catheter hub 20 and an exposed portion 24 that is exposed from the catheter hub 20.
  • the insertion portion 23 is entirely made of an elastic material, and is formed in a tapered shape that tapers toward the arrow A1 side.
  • the outer peripheral surface of the insertion portion 23 is in surface contact with the inner peripheral surface of the catheter hub 20.
  • the exposed portion 24 is formed in a disk shape which is connected to the base end of the insertion portion 23 and has an elastic portion 24a integrally formed with the insertion portion 23 and a hard portion 24b which covers the outside of the elastic portion 24a in an annular shape. ..
  • the radial outer side of the exposed portion 24 protrudes to the same extent as the flange portion 21 in the assembled state of the catheter hub 20 and the valve member 22.
  • a valve hole 25 that can be elastically opened and closed is provided at the axial center of the insertion portion 23 and the exposed portion 24.
  • the inner needle 14 and the tip of the safety member 40 are inserted into the valve hole 25 in the state before puncture, and the inner surface of the valve hole 25 and the outer surface of the safety member 40 are in close contact with each other.
  • the valve member 22 puts the catheter hub 20 and the safety member 40 in a fitted state, and prevents blood from leaking when the inner needle 14 is punctured.
  • the inner needle 14 of the catheter assembly 10 is formed of a hollow tube body having rigidity capable of puncturing the skin of a living body.
  • a sharp needle tip 15 is formed at the tip of the inner needle 14.
  • a hollow portion 14a is formed through the inside of the inner needle 14 along the direction of the arrow A, and the hollow portion 14a has a tip opening 14a1 provided at the needle tip 15 and a base provided at the base end of the inner needle 14. It communicates with the end opening 14a2.
  • a lateral hole 14a3 for communicating the outside of the inner needle 14 and the hollow portion 14a is provided at a position slightly distant from the needle tip 15 on the arrow A2 side.
  • Examples of the constituent material of the inner needle 14 include stainless steel, aluminum or aluminum alloy, metal material such as titanium or titanium alloy, hard resin, ceramics and the like.
  • the inner needle 14 is firmly fixed to the inner needle hub 30 by appropriate fixing means such as fusion, adhesion, and insert molding.
  • the inner needle hub 30 has a grip fixing portion 31 fixed to the grip 18 and an inner needle hub 30 projecting upward (arrow C1 side) from the grip fixing portion 31. It has a holding frame portion 32 that directly holds the needle 14.
  • the grip fixing portion 31 has a width that is inserted into the accommodation space 18a of the grip 18, and is formed in an arcuate cross-section in which the central portion in the width direction is recessed downward along the bottom wall 91 of the grip 18.
  • On the lower surface of the grip fixing portion 31 a plurality of (three in the present embodiment) fixing convex portions 34 that project downward shortly and form a mounting mechanism 33 with the grip 18 are provided.
  • the plurality of fixing convex portions 34 are located in the middle of a pair of tip fixing convex portions 34a located on the tip side of the grip fixing portion 31 in the arrow A direction and arranged in the width direction, and the grip fixing portion 31 in the arrow A direction.
  • An intermediate fixing convex portion 34b is included.
  • the pair of tip fixing convex portions 34a are formed in a substantially cubic block, while the intermediate fixing convex portion 34b is formed in a substantially rectangular block long in the arrow A direction.
  • the holding frame portion 32 has a tubular portion 35 on the tip side that extends in the direction of arrow A for a predetermined length and fixes the inner needle 14.
  • the tubular portion 35 has a hole portion 35a into which the inner needle 14 is inserted as an axial center.
  • the holding frame portion 32 supports the tubular portion 35 via a plurality of frame plates 36 protruding from the upper surface of the grip fixing portion 31 and extending in the direction of arrow A.
  • Each frame plate 36 forms a space in which the blunt needle hub 51 described later can slide by floating the tubular portion 35.
  • the base end side of the holding frame portion 32 with respect to the tubular portion 35 constitutes a space that defines the slide range of the blunt needle hub 51.
  • the safety member 40 is inserted and fitted into the catheter hub 20 (valve member 22) so as to follow the catheter hub 20 in the moving process. It is composed.
  • the safety member 40 includes a cover body 41 that covers the outside of the inner needle 14 as it advances, a blunt needle 50 that protrudes from the needle tip 15 of the inner needle 14 after puncture, and a blunt needle hub 51 that holds the blunt needle 50. To be equipped.
  • the cover body 41 includes a tip cover portion 42 located on the arrow A1 side, a base end extension portion 43 connected to the upper portion of the tip cover portion 42 and extending a predetermined length toward the arrow A2 side, and a base end extension. It has a pair of projecting portions 44 projecting outward in the width direction from the existing portion 43. Further, an engaging protrusion 45 with which the blunt needle hub 51 is engaged is provided on the arrow A1 side (connecting portion of the tip cover portion 42) of the base end extending portion 43.
  • the tip cover portion 42 is formed in a cylindrical shape through which a protective space 42a capable of accommodating the inner needle 14 is formed.
  • the tip cover portion 42 is formed in a thin tubular shape on the tip side and a thicker tubular shape on the base end side than the tip side.
  • the outer peripheral surface of the tip cover portion 42 on the tip end side is inserted and brought into close contact with the valve member 22 in the state before puncture, so that the outer peripheral surface is frictionally fitted to the catheter hub 20 including the valve member 22.
  • the base end of the tip cover portion 42 faces the tip of the holding frame portion 32 of the inner needle hub 30.
  • the cover body 41 is designed so that the needle tip 15 is located closer to the base end side than the tip end of the tip cover portion 42 at the advance position where the movement of the cover body 41 is restricted by the grip 18.
  • the base end extending portion 43 is formed so as to have a connecting portion 43a projecting upward at the connecting portion with the tip cover portion 42 and extending from the connecting portion 43a to the base end side and slightly wider than the connecting portion 43a. It has a plate portion 43b.
  • the height (arrow C direction) of the connecting portion 43a is defined by suspending the tip cover portion 42.
  • the plate portion 43b has a thickness that makes the safety member 40 rigid so as not to be deformed in the vertical direction or the width direction.
  • the plate portion 43b extends along the upper portion of the inner needle hub 30 (holding frame portion 32) to the base end in the grip 18 in the state before puncture.
  • the pair of projecting portions 44 are formed in a plate shape thinner than the proximal end extending portion 43, and extend from the intermediate portion in the arrow A direction of the proximal end extending portion 43 to the proximal end.
  • Each protrusion 44 projects outward from the inner needle hub 30 (grip fixing portion 31) in the width direction (arrow B direction) and extends to a position near the side wall 77 of the grip 18 (see also FIG. 12).
  • Each protrusion 44 constitutes a guide mechanism 46 that guides the safety member 40 in the direction of arrow A in cooperation with the grip 18.
  • one of the pair of protrusions 44 (the arrow B1 side) of the protrusion 44 is provided with a guided protrusion 47 that protrudes toward the arrow C2 and extends along the direction of the arrow A.
  • the guided protrusion 47 constitutes a part of the guide mechanism 46 and is arranged inside the lower side wall 92 on the arrow B1 side of the grip 18 (lower grip 90), so that the safety member 40 is displaced in the width direction. To prevent.
  • the protruding portion 44 on the arrow B1 side has a locked convex portion 48 on the arrow B1 side (outside in the width direction) of the guided protrusion 47 and on the arrow A2 side of the protruding portion 44.
  • the locked convex portion 48 is locked to the locking portion 109 of the grip 18 at the advanced position where the safety member 40 has advanced, so that one of the safety movement limiting mechanism portions 49 that restricts the advancement and retreat of the cover body 41. To configure.
  • the locked convex portion 48 will be described in detail later.
  • the blunt needle 50 of the safety member 40 is a rod member (round bar) configured so that the inner needle 14 cannot puncture the catheter 12 or the living body, and is movably housed in the hollow portion 14a of the inner needle 14. Will be done.
  • the tip of the blunt needle 50 is formed in a shape blunter than the needle tip 15 of the inner needle 14 (for example, a polished flat surface), and the base end of the lateral hole 14a3 in the hollow portion 14a of the inner needle 14 in the state before puncture. It is located in the vicinity.
  • the blunt needle 50 constitutes the multiple tube 11 together with the catheter 12 and the inner needle 14 in the state before puncture. Then, as the safety member 40 advances, the tip of the blunt needle 50 is exposed from the needle tip 15.
  • the thickness of the blunt needle 50 may be slightly smaller than the diameter of the hollow portion 14a of the inner needle 14, and for example, the outer diameter may be set in the range of about 0.19 mm to 1.19 mm.
  • the material constituting the blunt needle 50 is not particularly limited as long as sufficient hardness can be obtained, and for example, stainless steel, superelastic alloys such as Ni—Ti alloys, shape memory alloys, cobalt alloys, etc. Examples thereof include precious metals such as gold and platinum, metal materials such as tungsten alloys, and resin materials having a predetermined hardness or higher.
  • the blunt needle hub 51 is configured to be movable relative to the inner needle 14, the inner needle hub 30, and the grip 18 by fixing and holding the blunt needle 50 and engaging with the cover body 41.
  • the blunt needle 50 advances and retreats following the advance and retreat of the blunt needle hub 51.
  • the blunt needle hub 51 has a blunt needle holding portion 52 for holding the blunt needle 50, and an arm portion 53 extending from the base end of the blunt needle holding portion 52 toward the tip end.
  • the blunt needle holding portion 52 is formed in a block shape having a predetermined height in the vertical direction, and the base end side of the blunt needle 50 is fixed at the upper portion thereof.
  • the blunt needle holding portion 52 is arranged in a space on the base end side of the holding frame portion 32 with respect to the tubular portion 35 in the state before puncture. Therefore, the blunt needle hub 51 advances with respect to the inner needle hub 30, and when the tip end surface of the blunt needle holding portion 52 comes into contact with the base end surface of the tubular portion 35, the subsequent advancement of the blunt needle hub 51 is prevented. ..
  • the arm portion 53 extends from the blunt needle holding portion 52 to the arrow A1 side by a predetermined length, and the entire extending portion is configured to be elastically deformable in the width direction.
  • an engaging portion 54 that engages with the engaging protrusion 45 of the cover body 41 before puncturing is provided.
  • the engaging portion 54 is composed of an inclined portion 55 located at the tip portion and a hook portion 56 that projects shorter toward the arrow A1 side than the inclined portion 55 and sandwiches the engaging protrusion 45 between the inclined portion 55.
  • the inclined portion 55 projects toward the arrow A1 side and the arrow B1 side (inside in the width direction).
  • the engaging protrusion 45 of the cover body 41 is formed in a triangular shape along the inclination of the inclined portion 55 in a plan sectional view, and is guided by the inclination of the inclined portion 55.
  • the hook portion 56 surrounds the engaging protrusion 45 between the plate piece 56a projecting from the connecting portion of the inclined portion 55 toward the arrow A1 and the plate piece 56a protruding shortly toward the arrow B1 from the tip of the plate piece 56a. Includes a convex portion 56b (to be caught).
  • the plate piece 56a of the hook portion 56 is elastic outward in the width direction when the cover body 41 advances at the stage where the movement of the blunt needle hub 51 is restricted (the stage where the blunt needle holding portion 52 abuts on the tubular portion 35). It is deformed to release the hook between the convex portion 56b and the engaging protrusion 45.
  • the safety member 40 is not limited to the above configuration as long as it can prevent the needle tip 15 of the inner needle 14 from being erroneously stabbed.
  • the safety member 40 may be composed of only the cover body 41 without the blunt needle 50 or the blunt needle hub 51.
  • the catheter operating member 60 is a member that advances and retreats the catheter 12, the catheter hub 20, and the safety member 40 based on the user's operation.
  • the catheter operating member 60 includes an operating plate portion 61 extending in the longitudinal direction of the grip 18 (direction of arrow A), a hub accommodating portion 62 connected to the base end of the operating plate portion 61 and accommodating the catheter hub 20, and a hub accommodating portion. It has an operation unit tubular portion 63 connected to the base end of 62 and accommodating the safety member 40.
  • the operation plate portion 61 is a portion where a user's finger is touched to perform an advance / retreat operation.
  • a plurality of tabs 64 are provided on the upper surface of the operation plate portion 61.
  • the most advanced tab 64a of the plurality of tabs 64 projects more than the other tabs 64, making it easier for the user's finger to push out the catheter operating member 60.
  • the operation plate portion 61 is formed to be thin, it has flexibility that can be bent in a direction away from the multi-layer tube 11.
  • the pair of side edges 61a of the operation plate portion 61 are arranged on the pair of rail walls 96 and 98 of the grip 18 described later in the state before puncture.
  • the material constituting the operation plate portion 61 (catheter operation member 60) is not particularly limited, and for example, the material mentioned in the catheter hub 20 can be appropriately selected.
  • a concave block 65 that warps toward the arrow C1 side toward the arrow A1 side is provided.
  • a groove 65a in which the catheter 12 is arranged in a punctured state is provided on the lower surface of the concave block 65 and in the center in the width direction.
  • the width of the groove 65a is formed to be slightly wider than the outer diameter of the catheter 12.
  • a plurality of ribs 66 that can come into contact with the catheter 12 are provided on the lower surface of the operation plate portion 61.
  • the hub accommodating portion 62 of the catheter operating member 60 has an accommodating chamber 62a for accommodating the catheter hub 20 including the valve member 22 inside, and is formed in a box shape in which the lower part of the accommodating chamber 62a is opened.
  • the hub accommodating portion 62 is formed to be narrower than the side wall 77 of the grip 18, and the movement is guided by the side wall 77 in the movement of the catheter operating member 60.
  • a gap 62b is provided on the tip surface of the hub accommodating portion 62 so as to extend only the catheter 12 (multiple tube 11) narrower than the diameter of the catheter hub 20.
  • the operation unit tubular portion 63 is formed in a cylindrical shape that protrudes from the proximal end surface of the hub accommodating portion 62 toward the proximal end by a predetermined length.
  • An insertion space 63a communicating with the accommodation chamber 62a of the hub accommodation portion 62 is provided inside the operation unit cylinder portion 63.
  • the insertion space 63a is formed so as to penetrate the inside of the operation portion tubular portion 63 in the axial direction, and the tip cover portion 42 of the safety member 40 (cover body 41) is inserted.
  • an arcuate rib 67 which is formed so as to project in the circumferential direction to reinforce the operating portion tubular portion 63 is provided.
  • the inner diameter of the insertion space 63a is set to be slightly larger than the outer diameter D of the safety member 40 (the tip cover portion 42 of the cover body 41) and smaller than the outer diameter of the catheter hub 20 and the valve member 22. Therefore, the operation unit cylinder portion 63 is configured to have a margin space 63a1 (see FIG. 12) with respect to the outer diameter D of the tip cover portion 42 to be inserted. As a result, the safety member 40 can rotate around the axis with respect to the catheter operating member 60.
  • the operation unit tubular portion 63 has a slit 63b formed over the entire axial length of the operation unit tubular portion 63. That is, the slit 63b communicates with the accommodating chamber 62a on the tip end side and extends linearly to the most basic end of the operation unit tubular portion 63.
  • the slit 63b allows the inner needle 14 to pass from the side of the operation unit cylinder 63 to the insertion space 63a, while allowing the tip cover portion 42 to pass from the insertion space 63a to the side of the operation unit 63a. Make it impossible.
  • the width W of the slit 63b is set to a dimension larger than the outer diameter ⁇ of the inner needle 14 having a circular cross section.
  • the width W of the slit 63b is set to be smaller than the outer diameter D of the tip cover portion 42 having a circular cross section. Therefore, the dimensions of the outer diameter ⁇ of the inner needle 14, the outer diameter D of the safety member 40 (the base end side of the tip cover portion 42), and the width W of the slit 63b have a relationship of ⁇ ⁇ W ⁇ D.
  • the width W of the slit 63b may be formed to be slightly smaller than the outer diameter ⁇ of the inner needle 14, and the operation unit tubular portion 63 may be elastically deformed when the inner needle 14 is passed through the slit 63b.
  • the operation unit tubular portion 63 is configured to have a certain length along the axial direction in order to suppress bending of the catheter operating member 60 with respect to the safety member 40.
  • the axial length L of the operation unit tubular portion 63 is preferably set to 1/3 or more of the axial length of the hub accommodating portion 62 accommodating the catheter hub 20.
  • the grip 18 of the catheter assembly 10 is formed to have an appropriate thickness that is easy for the user to hold, and extends for a predetermined length along the direction of arrow A.
  • a storage space 18a in which the catheter 12, the catheter hub 20, the safety member 40, and the catheter operating member 60 can advance and retreat is formed in the grip 18.
  • the accommodation space 18a communicates with the tip opening portion 18b of the grip 18 so that the catheter 12, the catheter hub 20, the safety member 40, and the catheter operating member 60 can be delivered.
  • the grip 18 is configured by mutually assembling an upper grip 70 (first member) and a lower grip 90 (second member) that can be divided in the arrow C direction (direction orthogonal to the longitudinal direction).
  • the upper grip 70 has a ceiling wall 71, a pair of upper side walls 72 and an upper rear wall 73, and is formed in a concave shape (bowl shape) open downward. ing.
  • the ceiling wall 71 has a covering portion 71a whose upper portion is unexposed from the intermediate portion in the direction of arrow A to the base end.
  • the covering portion 71a is formed in an arc shape in a cross-sectional view.
  • the pair of ridges 74 are close to the upper surface of the cover 41 (a pair of protrusions 44) above the cover 41, and form a part of a guide mechanism 46 that guides the advance / retreat of the cover 41 (FIG. 12). See also).
  • the ceiling wall 71 has a pair of (two-pronged) extending portions 76 because the operating portion exposed notch 75 is formed in the center in the arrow B direction on the tip side of the intermediate portion.
  • the pair of upper side walls 72 and the pair of ridges 74 extend from the base end of the covering portion 71a to substantially the tip of the pair of extension portions 76 (to the base end of the upper protrusion piece portion 78 described later), and are paired.
  • the extension portion 76 is reinforced.
  • the pair of upper side walls 72 project downward from the side side of the ceiling wall 71 to form the side wall 77 of the grip 18 together with the lower side wall 92 of the lower grip 90.
  • the upper side wall 72 on the arrow B1 side accommodates the locked convex portion 48 of the cover body 41 inside in each pre-puncture state, and the locked convex portion 48 is not exposed.
  • a plurality of upper recesses 72a for guiding the user's grip are formed on the tip end side of each upper side wall 72.
  • the operation portion exposed notch 75 of the upper grip 70 is composed of a pair of ridge portions 74 and communicates with the accommodation space 18a.
  • the operating portion exposed notch 75 exposes the tab 64 of the catheter operating member 60 so as to be able to advance and retreat.
  • the operating portion exposed notch 75 is opened at the tip to allow the catheter operating member 60 (tab 64) to advance and detach from the grip 18.
  • the pair of extending portions 76 extend on both sides of the operating portion exposed notch 75 so as to gradually decrease from the covering portion 71a toward the arrow A1 side.
  • Each tip of the pair of extending portions 76 is formed with an upper projecting piece portion 78 that is substantially flat and protrudes outward in the width direction from the pair of upper side walls 72.
  • tip fixing hooks 80 On the lower surface of the pair of upper protrusions 78, tip fixing hooks 80, which are a part of the fixing mechanism 79 of the upper grip 70 and the lower grip 90, are provided.
  • the pair of tip fixing hooks 80 project shortly downward and have claws projecting inward in the width direction at the protruding end (lower end).
  • a block projecting portion 81 projecting downward to the same extent as the upper side wall 72 is formed on the lower surface of the upper projecting piece portion 78 on the arrow B1 side.
  • the block protrusion 81 partially covers the outside of the safety movement limiting mechanism portion 49 (space portion 110) of the lower grip 90, which will be described later, in the width direction, and generally covers the locked convex portion 48 of the safety member 40 that has moved to the advanced position.
  • a positioning notch 82 is provided on the side surface of the first upper projecting piece portion 78a on the side of the arrow A1 side of the block projecting portion 81.
  • an upper bearing hole 83 for axially supporting the lower support member 120 described later is provided on the lower surface of the upper projecting piece portion 78 (hereinafter referred to as the second upper projecting piece portion 78b) on the arrow B2 side. Further, a positioning notch 82 is also provided on the side surface of the second upper projecting piece portion 78b on the arrow B2 side.
  • the upper rear wall 73 of the upper grip 70 projects shorter than the pair of upper side walls 72 toward the arrow C2 side, and the pair of ridges 74 are connected to the tip surface thereof.
  • a base end fixing hook 84 forming a part of the fixing mechanism 79 is provided and fixed at a position near the base end fixing hook 84 (arrow A2 side and arrow B1 side).
  • the hook 85 is formed as a protrusion.
  • the base end fixing hook 84 is provided with a claw that projects downward shortly and projects toward the arrow A1 side at the protruding end (lower end).
  • the lower grip 90 has a bottom wall 91, a pair of lower side walls 92 and a lower rear wall 93, and is formed in a concave shape (bowl shape) open upward. ing.
  • the predetermined range on the arrow A1 side of the bottom wall 91 is formed in an arc shape in which the center in the width direction is recessed downward, and is a guide surface 91a that guides the advance / retreat of the catheter hub 20.
  • the predetermined range on the arrow A2 side of the bottom wall 91 is formed to be lower than the guide surface 91a although it has the same shape as the guide surface 91a, and is a mounted portion 91b to which the inner needle hub 30 is mounted.
  • the mounted portion 91b is provided with a plurality of mounting holes 94 (three in the present embodiment) into which the fixing convex portions 34 of the inner needle hub 30 can be fitted.
  • the plurality of mounting holes 94 are located at positions separated from the pair of tip mounting holes 94a arranged in the width direction on the tip side of the mounted portion 91b by a predetermined distance in the proximal direction.
  • the pair of tip mounting holes 94a are formed in a rectangular shape slightly long in the arrow B direction, and the intermediate mounting holes 94b are formed in a long hole long in the arrow A direction.
  • the pair of lower side walls 92 of the lower grip 90 project upward (arrow C1 side) from the side side of the bottom wall 91 and cover substantially the entire direction of arrow A. It is postponed.
  • a plurality of lower recesses 92a that are connected to the upper recess 72a and guide the user's grip are formed.
  • the lower side wall 92 on the arrow B2 side has a rail wall 96 connected to the thick wall 95 on the upper side and inside (arrow B1 side) of the thick wall 95 while the lower portion is formed of the thick wall 95. That is, a step is formed on the upper part of the lower side wall 92 and on the arrow B2 side, and the upper side wall 72 of the upper grip 70 is arranged in this step portion so as to be in close contact with the side surface of the rail wall 96 in the assembled state. ..
  • the lower side wall 92 on the arrow B1 side has a thick wall 95 at the lower part, while the upper part of the thick wall 95 has a two-step step.
  • the arrow B1 side is formed at the lowest position at the upper end of the thick wall 95, and has a protruding wall 97 that projects shortly inside (from the central portion in the width direction to the arrow B2 side), and further, the upper end of the protruding wall 97 and the arrow. It has a rail wall 98 that projects short on the B2 side.
  • the height of the rail wall 98 on the arrow B1 side is the same as the height of the rail wall 96 on the arrow B2 side.
  • the upper side wall 72 of the upper grip 70 is arranged in the stepped portion composed of the thick wall 95 and the protruding wall 97 in the assembled state.
  • the locked convex portion 48 of the cover body 41 is arranged in the assembled state. That is, a guide space 99a (a part of the safety guide space 99) for the locked convex portion on which the locked convex portion 48 can slide is formed between the upper side wall 72 of the upper grip 70 and the rail wall 98. Will be done.
  • the guide mechanism 46 that guides the safety member 40 is composed of a pair of upper side walls 72 of the upper grip 70, a pair of ridges 74, and a pair of rail walls 96 and 98 of the lower grip 90. That is, in the assembled state of the upper grip 70 and the lower grip 90, a safety guide space 99 for guiding the protruding portion 44 of the safety member 40 is formed between the pair of ridge portions 74 and the upper and lower rail walls 96 and 98. ..
  • the safety member 40 arranges the rail wall 98 on the arrow B1 side of the lower grip 90 in the gap between the guided protrusion 47 and the locked convex portion 48 in the state where the guide mechanism 46 is constructed.
  • the side edge 61a of the operation plate portion 61 of the catheter operating member 60 is arranged on the pair of rail walls 96 and 98 so that the advancement and retreat of the catheter operating member 60 can be guided (FIG. 12).
  • the operation plate portion 61 is indicated by a two-dot chain line).
  • the safety guide space 99 shares the operating member guide space 100.
  • the safety guide space 99 is opened upward with the upper grip 70 separated from the lower grip 90, and is closed with the upper grip 70 fixed to the lower grip 90.
  • the pair of side edges 61a of the catheter operating member 60 are formed to have a width narrower than the width of the pair of protrusions 44 of the safety member 40, and are arranged on the pair of rail walls 96 and 98. Therefore, the operating member guide space 100 is set narrower than the safety guide space 99 by the supporting member 120 described later, and is opened at the tip (tip opening portion 18b) of the grip 18, so that the catheter operating member 60 can be delivered. It is supposed to be.
  • a pair of projecting bodies 101 projecting outward in the width direction from the pair of lower side walls 92 are provided at the tip of the lower grip 90.
  • the pair of projectiles 101 have a sufficient thickness along the direction of arrow C, and the upper surface thereof is located slightly higher than the upper ends of the rail walls 96 and 98.
  • the pair of projectiles 101 constitutes a fixing mechanism 79 for fixing the upper grip 70 and the lower grip 90, and an arrangement mechanism 102 for arranging the lower support member 120.
  • the projectile 101 on the arrow B1 side projects from the upper part of the lower side wall 92 toward the arrow B1.
  • a first fixing hole 103a which is a part of the fixing mechanism 79, is formed through the first projecting body 103 in the thickness direction.
  • the tip fixing hook 80 of the first upper projecting piece portion 78a is inserted into the first fixing hole 103a, so that the claw is caught on the lower end surface of the projecting body 101.
  • a positioning projection 104 that projects shortly upward is provided on the arrow B1 side of the first projecting body 103, and the positioning projection 104 is inserted into the positioning notch 82 of the first upper projecting piece portion 78a.
  • the projectile 101 on the arrow B2 side projects toward the arrow B2 above and below the lower side wall 92 (hereinafter, the arrow C1 side is referred to as the second projectile upper block 105, and the arrow C2 side is referred to as the second projectile lower block 106).
  • the support member 120 has a moving space 107 in which the support member 120 can rotate and move.
  • a bearing notch 105a that rotatably supports the lower support member 120 is provided on the tip end side of the second projectile upper block 105.
  • the bearing notch 105a is formed in a U shape open to the arrow B1 side in a plan view, and communicates with the inner accommodation space 18a.
  • the upper end portion of the bearing notch 105a is formed in a stepped shape having a diameter larger than that of the lower portion, and a pair of small protrusions 123 of the support member 120 described later are arranged in this stepped portion.
  • a second fixing hole 105b which is a part of the fixing mechanism 79, is formed through the base end side of the second projecting body upper block 105 in the thickness direction, and a second upper projecting piece is further formed on the arrow B2 side.
  • a positioning protrusion 104 to be inserted into the positioning notch 82 of the portion 78b is provided.
  • the second projectile lower block 106 is provided in a range facing the tip end side of the second projectile upper block 105 in order to form the arrangement mechanism 102 of the support member 120.
  • a lower bearing hole 108 that pivotally supports the lower support member 120 is provided on the upper surface of the second projecting lower block 106.
  • the support member 120 is a component that is rotatably attached by the arrangement mechanism 102 of the grip 18 and supports the catheter 12 (multi-tube 11) extending below the catheter operating member 60 in the pre-puncture state. Further, the support member 120 rotates when the wall of the hub accommodating portion 62 comes into contact with the movement of the catheter operating member 60, so that the catheter operating member 60 can be sent out from the accommodating space 18a.
  • the support member 120 has a shaft portion 121 extending in the direction of arrow C and a support main body portion 122 projecting in a direction orthogonal to the axis of the shaft portion 121.
  • a pair of small protrusions 123 having a guide plane 121a and a guide plane 121a connected to the upper end of the rail wall 96 are provided on the upper portion of the shaft portion 121.
  • the side edge 61a of the catheter operating member 60 is close to the guide plane 121a in the state before puncture, and restricts the rotation of the support member 120.
  • the support main body portion 122 is narrow in the vicinity of the connecting portion of the shaft portion 121 in a plan view, and becomes wider as the distance from the vicinity of the connecting portion is increased.
  • the upper surface of the support main body 122 is formed to be flat (parallel to the bottom wall 91) in the protruding direction from the shaft 121, and is inclined downward at the protruding end.
  • An inclined protrusion 122a along the upper surface is formed on the base end side of the protruding end.
  • the lower support member 120 configured in this way is inserted along the bearing notch 105a from above the lower grip 90 in a posture in which the support main body portion 122 is directed toward the arrow B1 side. At this time, the lower support member 120 is smoothly inserted into the bearing notch 105a and the lower bearing hole 108 by passing the vicinity of the connecting portion of the support main body portion 122 through the open portion of the bearing notch 105a on the accommodation space 18a side. ..
  • the upper end of the shaft portion 121 supported by the lower grip 90 is arranged in the upper bearing hole 83 of the upper grip 70.
  • the support main body 122 supports the catheter 12 and suppresses the deflection of the catheter 12.
  • the support member 120 becomes rotatable by the side edge 61a coming out of the guide plane 121a, and allows the catheter operating member 60 and the safety member 40 to be delivered.
  • a locking portion 109 which is the other side of the safety movement limiting mechanism portion 49 that restricts the movement of the safety member 40 (cover body 41), is provided. It is provided.
  • the locking portion 109 is a space portion 110 in which the lower side wall 92 is cut out from above, an advance limiting portion 111 facing the locked convex portion 48 in the advancing direction, and a retracting portion that regulates the retreat of the locked convex portion 48. It has a limiting unit 112.
  • the space portion 110 communicates with the tip of the safety guide space 99.
  • the advance restriction portion 111 projects from the upper side (arrow C1 side) of the space portion 110 toward the arrow A2 side, and is connected to the first projectile 103 formed on the outer side in the width direction.
  • the protruding end of the advance limiting portion 111 on the arrow A2 side is formed on the advance limiting surface 111a that restricts the advance of the locked convex portion 48.
  • the advance restriction surface 111a is formed flat along the direction of arrow C.
  • the retreat limiting portion 112 includes an elastic arm portion 113 extending in the space portion 110 toward the arrow A2 side, and a return portion 114 that is inclined and folded back toward the arrow C1 side and the arrow A1 side from the protruding end of the elastic arm portion 113.
  • the elastic arm portion 113 can be elastically deformed in the direction of arrow C, and when the locked convex portion 48 that is advancing comes into contact with the return portion 114, the elastic arm portion 113 is elastically deformed, and the locked convex portion 48 moves to the arrow A1 side. Then, it is elastically restored.
  • the return portion 114 protrudes to the same height position as the upper end of the rail wall 98.
  • the return portion 114 has a receding limiting surface 114a inclined toward the arrow A1 side toward the arrow C1 side on the inside of the return (opposite side of the advancing limiting surface 111a).
  • the locking portion 109 has an advancing position of the locked convex portion 48 between the advancing limiting surface 111a and the retreating limiting surface 114a.
  • the outer upper end portion of the return portion 114 is a guide surface 114b that facilitates overcoming of the locked convex portion 48 by inclining toward the arrow A1 side toward the arrow C1 side.
  • the return portion 114 is provided with a thin wall 114c protruding from the arrow B2 side of the retreat limiting surface 114a to the arrow A1 side.
  • the thin wall 114c is located at the same position as the rail wall 98 on the arrow B1 side in the width direction, and the inner side surface of the thin wall 114c guides the guided protrusion 47 of the cover body 41, and the arrow B2 of the locked convex portion 48. Prevents deviation to the side.
  • the locked convex portion 48 of the safety member 40 projects shortly from the protruding portion 44 toward the arrow B1 side, and is formed in a three-dimensional shape having a tip surface 48a, an upper surface 48b, a lower surface 48c, and a base end surface 48d. ..
  • the front end surface 48a is formed parallel to the arrow C direction
  • the upper surface 48b is formed parallel to the arrow A direction.
  • the lower surface 48c is inclined toward the arrow C2 side from the lower end of the tip surface 48a toward the arrow A2 side, and when the locked convex portion 48 gets over the return portion 114, it becomes a guide surface 114b of the return portion 114. It is a guided surface.
  • the base end surface 48d is inclined from the upper surface 48b toward the arrow C2 side toward the arrow A2 side, and when the locked convex portion 48 moves to the advance position, the base end surface 48d faces the same inclination direction as the retreat limiting surface 114a. To do. As a result, when a retreating force is applied to the safety member 40, the base end surface 48d of the locked convex portion 48 and the retreat limiting surface 114a are positively engaged with each other to regulate the retreat of the safety member 40.
  • the lower rear wall 93 of the lower grip 90 has a proximal flange 115 projecting toward the arrow C1 side and projecting toward the arrow A2 side with respect to the rail walls 96 and 98.
  • a third fixing hole 115a is formed through the base end flange 115 along the thickness direction.
  • the third fixing hole 115a is formed long in the direction of arrow B so that the base end fixing hook 84 and the fixing protrusion 85 can be inserted together.
  • the catheter assembly 10 is basically configured as described above, and the assembly of the catheter assembly 10 will be described below.
  • the catheter assembly 10 assembles each member according to the procedure shown in FIG. Generally, after assembling the inner / outer needle assembly 16 first, the inner / outer needle assembly 16 is arranged on the lower grip 90, and the upper grip 70 is further attached to the inner / outer needle assembly 16 and the lower grip 90.
  • a step of incorporating the safety member 40 into the inner needle 14 is performed (step S1).
  • a part in which the inner needle 14 and the inner needle hub 30 are fixed in advance, a part in which the blunt needle 50 and the blunt needle hub 51 are fixed in advance, and a cover body 41 are prepared.
  • the tip of the blunt needle 50 is inserted from the base end of the inner needle hub 30, and the blunt needle 50 is advanced along the hollow portion 14a of the inner needle 14.
  • the arm portion 53 of the blunt needle hub 51 is guided to the tip end side of the holding frame portion 32 through the space inside the holding frame portion 32 of the inner needle hub 30, and the blunt needle holding portion 52 of the blunt needle hub 51 is the holding frame portion. It is arranged at a position facing the base end of the tubular portion 35 in 32.
  • the tip of the inner needle 14 is inserted from the base end of the tip cover portion 42 (protection space 42a) of the cover body 41. Since the tip cover portion 42 has a thick tubular shape on the base end side and a wide protective space 42a, the needle tip 15 of the inner needle 14 can be easily entered.
  • the cover body 41 is moved toward the proximal end along the inner needle 14, and the engaging protrusion 45 of the cover body 41 reaches the tip of the arm portion 53 of the blunt needle hub 51 that has passed through the inner needle hub 30, the engagement is engaged.
  • the combined protrusion 45 and the engaging portion 54 are engaged and integrated as a safety member 40. That is, at this stage, the inner needle 14 is exposed from the tip of the safety member 40 to form the safety holding assembly 130.
  • step S2 a step of incorporating a component (indwelling body) to which the catheter 12 and the catheter hub 20 (including the valve member 22) are fixed in advance into the safety holding assembly 130 including the inner needle 14 and the safety member 40 is performed (step).
  • step S2 As shown in FIG. 17, with the valve member 22 inserted in the catheter hub 20, the tip of the inner needle 14 is inserted into the valve hole 25 of the valve member 22 from the proximal end side. At this time, since the tip cover portion 42 of the cover body 41 has not yet been inserted into the valve member 22, the valve hole 25 is easily opened. Therefore, the valve member 22 smoothly moves on the outer peripheral surface of the inner needle 14 while suppressing the sticking of the inner needle 14.
  • the catheter hub 20 is temporarily attached to the outer peripheral surface of the tip cover portion 42.
  • the catheter hub 20 and the tip cover portion 42 are fitted via the valve member 22.
  • a multi-tube 11 is formed in which the needle tip 15 of the inner needle 14 protrudes from the tip of the catheter 12.
  • a step of immersing (dip) the catheter 12 and the inner needle 14 in the coating material 13 is performed (step S3).
  • the coating material 13 is stored in a storage tank (not shown), and the tip of the multi-layer pipe 11 having the safety holding assembly 130 at the base end is directed downward to enter the stored liquid from above to below. ..
  • the catheter hub 20 waits for a certain period of time at a position where it is not immersed, and then the multilayer tube 11 is pulled upward.
  • the coating material 13 is applied to the surface of the catheter 12 and the needle tip 15. Further, at the time of dipping, since the catheter operating member 60 is not attached, the coating material 13 is not applied to the catheter operating member 60.
  • step S4 a step of incorporating the catheter operating member 60 is performed (step S4).
  • the catheter hub 20 and the safety member 40 that have been fitted for dipping are separated. That is, as shown in FIG. 17, the catheter hub 20 is relatively moved in the axial direction (tip direction) with respect to the safety member 40 (safety holding assembly 130). As a result, the inner needle 14 is exposed at the base end of the catheter hub 20 with respect to the valve member 22 and at the tip end with respect to the tip end cover portion 42.
  • the catheter operating member 60 is mounted from the side with the inner needle 14 exposed between the base end of the valve member 22 and the tip of the safety member 40.
  • the width W of the slit 63b formed in the operating portion tubular portion 63 of the catheter operating member 60 is larger than the outer diameter ⁇ of the inner needle 14, the insertion space 63a of the operating portion tubular portion 63 is passed through the slit 63b.
  • the inner needle 14 can be smoothly inserted into the slit.
  • the hub accommodating portion 62 of the catheter operating member 60 is open at the lower side, the catheter hub 20 (including the valve member 22) can be easily inserted into the accommodating chamber 62a with the inner needle 14 inserted.
  • the catheter hub 20 (including the valve member 22) housed in the catheter operating member 60
  • the catheter hub 20 and the catheter operating member 60 are moved toward the proximal end.
  • the tip of the safety member 40 is reinserted into the valve hole 25 of the valve member 22.
  • the safety member 40 reaches the valve member 22. It will be in a state of being tightly fitted to.
  • the inner / outer needle assembly 16 in which the catheter 12, the catheter hub 20, the inner needle 14, the inner needle hub 30, the safety member 40, and the catheter operating member 60 are assembled is constructed.
  • step S5 the step of arranging the previously assembled inner / outer needle assembly 16 on the lower grip 90 is performed (step S5).
  • the lower grip 90 is in a state where the support member 120 is attached by the above-mentioned assembly method (see FIGS. 13A and 13B).
  • the inner / outer needle assembly 16 is inserted from the upper open portion of the lower grip 90 toward the lower side (arrow C2 side), and the plurality of fixing convex portions 34 of the inner needle hub 30 are inserted. Is inserted and fitted into the plurality of mounting holes 94 of the lower grip 90, respectively (see also FIG. 11). As a result, the inner / outer needle assembly 16 engages with the lower grip 90.
  • the safety guide space 99 (space 110) and the operating member guide space 100 formed between the upper grip 70 and the lower grip 90 are opened in a state where the upper grip 70 is separated from the lower grip 90. .. Therefore, the safety member 40 and the catheter operating member 60 can be easily arranged by inserting the inner / outer needle assembly 16 into the lower grip 90 toward the arrow C2 side.
  • step S6 a step of attaching the upper grip 70 to the lower grip 90 with which the inner / outer needle assembly 16 is engaged is performed (step S6). That is, the upper grip 70 is brought closer from the upper side of the lower grip 90 toward the lower side (arrow C2 side), and the tip fixing hooks 80 of the first and second upper projecting pieces 78a and 78b of the upper grip 70 are attached to the lower grip 90. It is inserted into the first and second fixing holes 103a and 105b of the above, and hooked on the first projecting body 103 and the second projecting body upper block 105.
  • the base end fixing hook 84 and the fixing protrusion 85 of the upper grip 70 are inserted into the third fixing hole 115a of the lower grip 90, and the base end fixing hook 84 is hooked on the base end flange 115.
  • the upper grip 70 and the lower grip 90 are firmly integrated as the grip 18 by fixing the two places where the catheter operating member 60 is sandwiched between them at the tip and one place at the base end to each other. It becomes.
  • the catheter assembly 10 is in the pre-puncture state after the assembly is completed by fixing the upper grip 70 and the lower grip 90.
  • the safety guide space 99 space portion 110 in which the pair of protruding portions 44 (locked convex portions 48) of the safety member 40 are arranged is closed in the direction of the arrow A of the upper grip 70 and the lower grip 90.
  • the pair of protrusions 44 are made inseparable.
  • the inner needle hub 30 is fixed to the grip 18, so that the inner needle 14 cannot move, while the catheter 12, the catheter hub 20, the safety member 40, and the catheter operating member 60 are inside. It is possible to move forward and backward relative to the needle 14.
  • the present invention is not limited to the above embodiment, and various modifications can be made according to the gist of the invention.
  • the mounting mechanism 33 for fixing the inner needle hub 30 and the lower grip 90 is not limited to the above, and may have various configurations (adhesive structure, fixing structure by hook, etc.).
  • the fixing mechanism 79 for fixing the upper grip 70 and the lower grip 90 is not limited to the above, and may have various configurations (adhesive structure, fitting structure, etc.).
  • the catheter assembly 10A according to the modified example shown in FIGS. 19A and 19B has a structure for guiding and restricting the movement of the safety member 40A in a direction different from the location where the operating portion of the catheter operating member 60A is arranged. Therefore, it is different from the catheter assembly 10 described above.
  • elements having the same configuration or the same function as those in the above embodiment are designated by the same reference numerals, and detailed description thereof will be omitted.
  • the grip 18A of the catheter assembly 10A can be divided into an upper grip 140 and a lower grip 150, but the upper grip 140 includes a ceiling wall 71 and a rear block body 141 on the arrow A2 side. , The structure does not have a side wall.
  • the lower grip 150 has a bottom wall 91 and a pair of side walls 77, but does not have a rear wall on the arrow A2 side. Further, the lower grip 150 is provided with a guide elongated hole 151 (safety guide space 99) for guiding the locked convex portion 48A of the safety member 40A in the bottom wall 91. The tip of the long guide hole 151 is closed while the lower grip 150 alone has an open base end. The base end opening portion of the guide elongated hole 151 is closed by the rear block body 141 as the upper grip 140 is attached to the lower grip 150.
  • a guide elongated hole 151 safety guide space 99
  • an operating member guide space 100 is formed between the ceiling wall 71 of the upper grip 140 and each side wall 77 of the lower grip 150.
  • a pair of wings 68 (operating portions) of the catheter operating member 60A are arranged in the pair of operating member guide spaces 100, respectively.
  • the catheter operating member 60A is engaged with the catheter hub 20 or the safety member 40A, and the user can advance and retreat the catheter 12, the catheter hub 20 and the safety member 40A based on the operation of the pair of wings 68.
  • the inner / outer needle assembly 16A of the catheter assembly 10A is configured by assembling a catheter 12, a catheter hub 20, an inner needle 14, an inner needle hub 30, a safety member 40A, and a catheter operating member 60A.
  • the inner needle hub 30 fixes the base end of the inner needle 14 and is fixed to a mounting portion (not shown) on the base end side of the lower grip 150 constituting the mounting mechanism 33.
  • the safety member 40A includes the above-mentioned locked convex portion 48A at the base end portion of the tubular portion through which the inner needle 14 is inserted.
  • the locked convex portion 48A protrudes toward the arrow C2 side by a predetermined length, and the protruding end thereof is configured to be wider than the guide elongated hole 151. Therefore, the locked convex portion 48A (safety member 40A) is prevented from coming off from the guide elongated hole 151 in the assembled state.
  • the long guide hole 151 extends along the longitudinal direction of the lower grip 150 (direction of arrow A), and the closing portion 152 at the tip thereof reaches the vicinity of the tip of the lower grip 150.
  • a locking portion 153 that restricts the movement of the locked convex portion 48A (safety member 40A) at the advanced advance position of the locked convex portion 48A slightly closer to the base end side of the guide elongated hole 151 than the closed portion 152 ( A part of the safety movement restriction mechanism unit 49) is provided.
  • the locking portion 153 is composed of a closing portion 152 at the tip of the guide elongated hole 151 and a convex portion 154 (return piece portion) that narrows the guide elongated hole 151 inward in the width direction.
  • the convex portion 154 is elastically deformed when the locked convex portion 48A is advanced on the arrow A1 side to move the locked convex portion 48A to the advanced position, while the locked convex portion 48A moved to the advanced position is It regulates the retreat to the arrow A2 side.
  • the safety member 40A is exposed from the grip 18A together with the catheter hub 20 and the movement of the safety member 40A is restricted while covering the needle tip 15 of the inner needle 14 at the advanced position. Can be prevented.
  • a pair of wings 68 of the catheter operating member 60A are arranged at the boundary between the upper grip 140 and the lower grip 150 (operation member guide space 100) so that the catheter assembly 10A can be moved. Therefore, the delivery of the catheter operating member 60A from the grip 18A is simplified. Further, since the safety movement limiting mechanism portion 49 of the safety member 40A is not shared with the operating member guide space 100, the configuration of the tip portion of the grip 18A is simplified, and the advance / retreat of the safety member 40A at the advance position is more firmly restricted. It becomes possible to do.
  • One aspect of the present invention is a catheter operating member for the user to operate the catheter 12, the catheter hub 20 for holding the catheter 12, the internal needle 14 inserted through the catheter 12, and the catheter 12 and the catheter hub 20. It can be moved together with the catheter hub 20 by being inserted into the catheter hub 20 and fitted with the 60, and it advances beyond the needle tip 15 of the inner needle 14 pierced by the treatment target and erroneously punctures the inner needle 14.
  • a catheter assembly 10 including a safety member 40 that activates a prevention function, wherein the catheter operating member 60 includes a tubular portion (operating unit tubular portion 63) having an insertion space 63a into which the safety member 40 is inserted, and a tubular portion.
  • the slit 63b has a slit 63b extending in the axial direction of the catheter portion, and the slit 63b allows the inner needle 14 to pass through the insertion space 63a from the side of the tubular portion, while the slit 63b from the insertion space 63a to the side of the tubular portion.
  • the passage of the safety member 40 is disabled.
  • the catheter assembly 10 has a configuration in which the safety member 40 is inserted and fitted into the catheter hub 20, so that the catheter hub 20 and the safety member 40 can be inserted into the catheter hub 20 and the safety member 40.
  • the member 40 can be fitted in the axial direction.
  • the catheter operating member 60 has a tubular portion (operating unit tubular portion 63) and a slit 63b, and while the slit 63b allows the inner needle 14 to pass through, the safety member 40 cannot pass through.
  • the catheter operating member 60 can be attached from the side of the inner needle 14 via the slit 63b in a state where the inner needle 14 is inserted into the catheter hub 20 and brought close to the tip of the safety member 40.
  • the safety member 40 through which the tubular portion is inserted into the catheter hub 20 by directing the tubular portion toward the safety member 40. Therefore, the assembly of the catheter hub 20, the safety member 40, and the catheter operating member 60 can be simplified, and the work efficiency can be significantly improved.
  • the width W of the slit 63b is formed to be larger than the diameter (outer diameter ⁇ ) of the inner needle 14 and smaller than the width (outer diameter D) of the safety member 40.
  • the catheter hub 20 has a configuration in which the valve member 22 is inserted inside, and the safety member 40 is inserted into the valve hole 25 of the valve member 22 and fitted into the catheter hub 20 via the valve member 22.
  • the catheter assembly 10 can cause the catheter hub 20 to hold the safety member 40 with an appropriate fitting force via the valve member 22.
  • the catheter operating member 60 has a hub accommodating portion 62 accommodating the catheter hub 20, and is configured to follow the catheter hub 20 and the safety member 40 as the hub accommodating portion 62 moves by the user's operation.
  • the hub accommodating portion 62 can be detached from the catheter hub 20 based on the release of the fitting between the catheter hub 20 and the safety member 40.
  • the catheter assembly 10 can easily disengage the catheter hub 20 from the catheter operating member 60 when the catheter hub 20 and the safety member 40 are disengaged from each other.
  • the catheter 12 and the inner needle 14 are immersed in a predetermined coating material 13 in a state of being overlapped with each other, so that the coating material 13 is applied to the surface.
  • the catheter 12 and the inner needle 14 can be immersed in the coating material 13 in a state of being overlapped with each other, so that the manufacturing process can be simplified and the work efficiency can be further improved.
  • the coating material 13 is a material that reduces the insertion resistance of the catheter 12 with respect to the treatment target. As a result, the coating material 13 is applied to the multi-tube 11 on which the catheter 12 and the inner needle 14 are overlapped, so that the catheter 12 can be smoothly inserted into the treatment target.
  • the catheter operating member 60 has an operating portion (operating plate portion 61) extending to the distal end side of the catheter hub 20 and being operated by the user, and is applied to the catheter hub 20 and the safety member 40 after the coating material 13 is applied. Will be inserted.
  • the coating material 13 can be applied to the multilayer tube 11 without the catheter operating member 60, which further simplifies the assembly and reduces the manufacturing cost. it can.
  • the portion where the safety member 40 is inserted into the catheter hub 20 and the tubular portion (operation unit tubular portion 63) and the tubular portion are formed in a cylindrical shape, and the inner diameter of the tubular portion is the safety member 40 through which the safety member 40 is inserted. It is set to a dimension having a margin space 63a1 with respect to the outer diameter of. As a result, the catheter assembly 10 can smoothly insert the safety member 40 when the safety member 40 is inserted into the tubular portion of the catheter operating member 60 and the safety member 40 is inserted into the catheter hub 20. ..
  • the safety member 40 can be relatively rotated when the safety member 40 is inserted into the catheter hub 20, and the insertion and fitting can be performed. It is possible to perform it stably.
  • the length L of the tubular portion (operation unit tubular portion 63) along the axial direction is 1/3 or more of the length along the axial direction of the hub accommodating portion 62 accommodating the catheter hub 20 in the catheter operating member 60. Is set to. As a result, in the catheter assembly 10, the distance between the tubular portion of the catheter operating member 60 and the safety member 40 is increased, and the bending of the catheter operating member 60 with respect to the safety member 40 is suppressed when the catheter operating member 60 is operated. .. Therefore, the catheter operating member 60 can smoothly move the safety member 40.

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Abstract

A catheter assembly (10) comprises: a catheter (12); an inner needle (14); a safety member (40); and a catheter operating member (60). The safety member (40) is movable together with a catheter hub (20) by being inserted and fitted in the catheter hub (20). The catheter operating member (60) comprises: an operating unit cylinder portion (63) having an insertion space (63a) through which the safety member (40) is inserted; and a slit (63b) extending in an axial direction of the operating unit cylinder portion (63). The slit (63b) allows the inner needle (14) to pass through the insertion space (63a) from the side of the operating unit cylinder portion (63), and disables the safety member (40) from passing from the insertion space (63a) to the side of the operating unit cylinder portion(63).

Description

カテーテル組立体Catheter assembly
　本発明は、内針の誤刺を防止するセーフティ部材を有するカテーテル組立体に関する。 The present invention relates to a catheter assembly having a safety member for preventing accidental puncture of an inner needle.
　輸液や輸血等の導入部を処置対象（患者）に形成する際には、特表２０１３－５２９１１１号公報に開示されているようなカテーテル組立体が使用される。このカテーテル組立体は、カテーテル（外針）に内針を挿通した多重管を有する。このカテーテル組立体の使用において、ユーザは、多重管を患者の体内に穿刺し、その後カテーテルを血管内に進入させ、さらにカテーテルから内針を抜去してカテーテルを留置する。 When forming an introduction part for infusion or blood transfusion as a treatment target (patient), a catheter assembly as disclosed in Japanese Patent Publication No. 2013-529111 is used. This catheter assembly has a multi-tube with an inner needle inserted through a catheter (outer needle). In the use of this catheter assembly, the user punctures a multi-tube into the patient's body, then allows the catheter to enter the blood vessel, and further removes the internal needle from the catheter to place the catheter.
　また、特表２０１３－５２９１１１号公報に開示のカテーテル組立体は、カテーテル及びカテーテルハブを進退操作するためのカテーテル操作部材と、カテーテル操作部材の進退に追従して移動し、内針の針先を覆うことで内針の誤刺防止機能を発動するセーフティ部材とを有する。 Further, the catheter assembly disclosed in Japanese Patent Application Laid-Open No. 2013-529111 moves with the catheter operating member for advancing and retreating the catheter and the catheter hub, and the needle tip of the internal needle by following the advancing and retreating of the catheter operating member. It has a safety member that activates the function of preventing accidental puncture of the inner needle by covering it.
　ところで、特表２０１３－５２９１１１号公報に開示されているようなセーフティ部材を有するカテーテル組立体は、カテーテルハブ又はカテーテル操作部材にセーフティ部材を係合させることで、セーフティ部材を追従させ、誤刺防止機能の発動に伴い係合を解除させるように構成される。このため、カテーテル組立体は、カテーテル、カテーテルハブ、内針、セーフティ部材、カテーテル操作部材同士の係合構造が複雑になり易く、各部材同士の組立作業に手間がかかる。 By the way, in a catheter assembly having a safety member as disclosed in Japanese Patent Application Laid-Open No. 2013-529111, the safety member is made to follow by engaging the safety member with the catheter hub or the catheter operating member to prevent accidental puncture. It is configured to disengage as the function is activated. Therefore, in the catheter assembly, the engagement structure between the catheter, the catheter hub, the inner needle, the safety member, and the catheter operating member tends to be complicated, and the assembling work of each member is troublesome.
　本発明は、上記のカテーテル組立体の技術に関連するものであり、各部材の組立が簡易化し作業効率を大幅に向上させることができるカテーテル組立体を提供することを目的とする。 The present invention relates to the above-mentioned technique of a catheter assembly, and an object of the present invention is to provide a catheter assembly capable of simplifying the assembly of each member and greatly improving work efficiency.
　前記の目的を達成するために、本発明の一態様は、カテーテルと、前記カテーテルを保持するカテーテルハブと、前記カテーテルに挿通された内針と、前記カテーテル及び前記カテーテルハブの移動をユーザが操作するためのカテーテル操作部材と、前記カテーテルハブ内に挿入されて嵌合することで当該カテーテルハブと共に移動可能であり、処置対象に穿刺した前記内針の針先よりも進出して当該内針の誤刺防止機能を発動するセーフティ部材とを備えるカテーテル組立体であって、前記カテーテル操作部材は、前記セーフティ部材が挿通される挿通空間を有する筒部と、前記筒部の軸方向に延在するスリットとを有し、前記スリットは、前記筒部の側方から前記挿通空間に前記内針を通過可能とする一方で、前記挿通空間から前記筒部の側方への前記セーフティ部材の通過を不能とする。 In order to achieve the above object, one aspect of the present invention is for a user to operate a catheter, a catheter hub for holding the catheter, an internal needle inserted through the catheter, the catheter and the movement of the catheter hub. It can be moved together with the catheter hub by being inserted into the catheter hub and fitted with the catheter operating member for the purpose of moving, and the inner needle advances beyond the tip of the inner needle pierced by the treatment target. A catheter assembly including a safety member that activates an erroneous puncture prevention function, wherein the catheter operating member extends in an axial direction of a tubular portion having an insertion space into which the safety member is inserted and an insertion space. It has a slit, which allows the inner needle to pass from the side of the tubular portion to the insertion space, while allowing the safety member to pass from the insertion space to the side of the tubular portion. Make it impossible.
　上記のカテーテル組立体は、各部材の組立が簡易化し作業効率を大幅に向上させることができる。 The above catheter assembly simplifies the assembly of each member and can greatly improve work efficiency.
本発明の一実施形態に係るカテーテル組立体の斜視図である。It is a perspective view of the catheter assembly which concerns on one Embodiment of this invention. カテーテル組立体の分解斜視図である。It is an exploded perspective view of a catheter assembly. 図３Ａは、カテーテル組立体の使用時の手順を示す第１動作図である。図３Ｂは、カテーテル組立体の使用時の手順を示す第２動作図である。FIG. 3A is a first operation diagram showing a procedure when using the catheter assembly. FIG. 3B is a second operation diagram showing a procedure when using the catheter assembly. 図４Ａは、カテーテル組立体の使用時の手順を示す第３動作図である。図４Ｂは、カテーテル組立体の使用時の手順を示す第４動作図である。FIG. 4A is a third operation diagram showing a procedure when using the catheter assembly. FIG. 4B is a fourth operation diagram showing a procedure when using the catheter assembly. カテーテル組立体の側面断面図である。It is a side sectional view of the catheter assembly. 図６Ａは、内針を支持する内針ハブを下側から見た斜視図である。図６Ｂは、内針を支持する内針ハブの正面図である。FIG. 6A is a perspective view of the inner needle hub that supports the inner needle as viewed from below. FIG. 6B is a front view of the inner needle hub that supports the inner needle. 図７Ａは、セーフティ部材を下側からみた斜視図である。図７Ｂは、カバー体が内針を覆った状態を示す斜視図である。FIG. 7A is a perspective view of the safety member as viewed from below. FIG. 7B is a perspective view showing a state in which the cover body covers the inner needle. カテーテルハブ及びカバー体にカテーテル操作部材を組み付けた状態を下側から見た斜視図である。It is a perspective view which looked at the state which attached the catheter operation member to a catheter hub and a cover body from the lower side. 上グリップを下側から見た斜視図である。It is a perspective view which looked at the upper grip from the lower side. 下グリップを示す斜視図である。It is a perspective view which shows the lower grip. 内針ハブと下グリップの固定を説明する説明図である。It is explanatory drawing explaining the fixing of the inner needle hub and the lower grip. 図５のＸＩＩ－ＸＩＩ線断面図である。FIG. 5 is a cross-sectional view taken along the line XII-XII of FIG. 図１３Ａは、下グリップ及び下支え部材の組立前の状態を示す斜視図である。図１３Ｂは、下グリップ及び下支え部材の組立状態を示す斜視図である。FIG. 13A is a perspective view showing a state before assembling the lower grip and the lower support member. FIG. 13B is a perspective view showing an assembled state of the lower grip and the lower support member. グリップによりカバー体の移動を制限するセーフティ移動制限機構部を示す部分側面断面図である。It is a partial side sectional view which shows the safety movement restriction mechanism part which restricts the movement of a cover body by a grip. カテーテル組立体の組立時の手順を示すフローチャートである。It is a flowchart which shows the procedure at the time of assembling the catheter assembly. カテーテル組立体の組立手順を示す第１説明図である。It is 1st explanatory drawing which shows the assembly procedure of a catheter assembly. カテーテル組立体の組立手順を示す第２説明図である。It is a 2nd explanatory drawing which shows the assembly procedure of a catheter assembly. カテーテル組立体の組立手順を示す第３説明図である。It is a 3rd explanatory drawing which shows the assembly procedure of a catheter assembly. 図１９Ａは、変形例に係るカテーテル組立体の分解状態を模式的に示す斜視図である。図１９Ｂは、図１９Ａのカテーテル組立体の長手方向と直交する方向の断面図である。FIG. 19A is a perspective view schematically showing a disassembled state of the catheter assembly according to the modified example. FIG. 19B is a cross-sectional view of the catheter assembly of FIG. 19A in a direction orthogonal to the longitudinal direction.
　以下、本発明について好適な実施形態を挙げ、添付の図面を参照して詳細に説明する。 Hereinafter, preferred embodiments of the present invention will be given and described in detail with reference to the accompanying drawings.
　本発明の一実施形態に係るカテーテル組立体１０は、図１に示すように、処置対象（生体）に輸液、輸血又は採血等を行う際に用いられ、処置対象の体内にカテーテル１２を挿入及び留置して体内と体外を導通させる。カテーテル組立体１０は、末梢静脈カテーテルよりも長さが長いカテーテル１２（例えば、中心静脈カテーテル、ＰＩＣＣ、ミッドラインカテーテル等）を挿入可能とする。なお、カテーテル組立体１０は、末梢静脈カテーテルを挿入可能な構成でもよい。また、カテーテル組立体１０は、静脈用カテーテルに限らず、末梢動脈カテーテル等の動脈用カテーテルを挿入するものでもよい。 As shown in FIG. 1, the catheter assembly 10 according to the embodiment of the present invention is used when infusing, transfusing, or collecting blood to a treatment target (living body), and the catheter 12 is inserted into the treatment target and the catheter 12 is inserted into the body of the treatment target. Indwell to make the inside and outside of the body conductive. The catheter assembly 10 allows the insertion of a catheter 12 (eg, central venous catheter, PICC, midline catheter, etc.) that is longer than the peripheral venous catheter. The catheter assembly 10 may have a configuration in which a peripheral venous catheter can be inserted. Further, the catheter assembly 10 is not limited to the intravenous catheter, and may be one into which an arterial catheter such as a peripheral arterial catheter is inserted.
　図１及び図２に示すように、カテーテル組立体１０は、使用前（穿刺前）の状態で、カテーテル１２、内針１４、カテーテルハブ２０、内針ハブ３０、セーフティ部材４０及びカテーテル操作部材６０を組み付けた内外針組立体１６を備える。さらに、カテーテル組立体１０は、内外針組立体１６を収容すると共に、ユーザが把持するためのグリップ１８（ハウジング）を備える。 As shown in FIGS. 1 and 2, the catheter assembly 10 has a catheter 12, an inner needle 14, a catheter hub 20, an inner needle hub 30, a safety member 40, and a catheter operating member 60 in a state before use (before puncture). The inner / outer needle assembly 16 is provided. Further, the catheter assembly 10 accommodates the inner / outer needle assembly 16 and includes a grip 18 (housing) for the user to grip.
　穿刺前状態の内外針組立体１６は、カテーテル１２及びカテーテルハブ２０内を内針１４が貫通し、内針１４の針先１５がカテーテル１２の先端より突出した多重管１１を形成している。カテーテルハブ２０よりも基端側には、内針１４が挿通されたセーフティ部材４０が配置され、さらにセーフティ部材４０の基端側に内針１４を保持した内針ハブ３０が配置される。カテーテル操作部材６０は、カテーテル１２、カテーテルハブ２０、セーフティ部材４０の上方に配置され、これらの部材を進退可能としている。グリップ１８内には、多重管１１の基端側部分を含む内外針組立体１６が収容され、このグリップ１８に対して内針ハブ３０が固定されている。 In the inner / outer needle assembly 16 in the pre-puncture state, the inner needle 14 penetrates the inside of the catheter 12 and the catheter hub 20, and the needle tip 15 of the inner needle 14 forms a multi-tube 11 protruding from the tip of the catheter 12. A safety member 40 through which the inner needle 14 is inserted is arranged on the proximal end side of the catheter hub 20, and an inner needle hub 30 holding the inner needle 14 is arranged on the proximal end side of the safety member 40. The catheter operating member 60 is arranged above the catheter 12, the catheter hub 20, and the safety member 40, and these members can move forward and backward. The inner / outer needle assembly 16 including the proximal end side portion of the multiple tube 11 is housed in the grip 18, and the inner needle hub 30 is fixed to the grip 18.
　本実施形態に係るカテーテル組立体１０の理解の容易化のため、先にカテーテル組立体１０の使用時の動作について説明する。医師や看護師等のユーザは、使用時に、図３Ａに示す穿刺前状態のカテーテル組立体１０のグリップ１８を把持して、カテーテル１２及び内針１４を患者（処置対象）の血管（静脈又は動脈）内に穿刺する。この穿刺状態を維持したまま、ユーザは、グリップ１８（内針ハブ３０を含む）に対しカテーテル操作部材６０を相対的に進出させることで、カテーテル１２及びカテーテルハブ２０を進出させる。これによりカテーテル１２が血管の奥に進入していく。またカテーテル操作部材６０の進出初期時には、カテーテル１２及びカテーテルハブ２０の移動に伴ってセーフティ部材４０も一体的に移動する。 In order to facilitate understanding of the catheter assembly 10 according to the present embodiment, the operation of the catheter assembly 10 when it is used will be described first. At the time of use, a user such as a doctor or a nurse grasps the grip 18 of the catheter assembly 10 in the pre-puncture state shown in FIG. 3A, and holds the catheter 12 and the internal needle 14 to the blood vessel (vein or artery) of the patient (treatment target). ) To puncture. While maintaining this puncture state, the user advances the catheter 12 and the catheter hub 20 by relatively advancing the catheter operating member 60 with respect to the grip 18 (including the inner needle hub 30). As a result, the catheter 12 enters the back of the blood vessel. Further, at the initial stage of advancement of the catheter operating member 60, the safety member 40 also moves integrally with the movement of the catheter 12 and the catheter hub 20.
　図３Ｂに示すように、上記の進出操作によって、カテーテル１２及びカテーテルハブ２０がグリップ１８の先端から抜け出し、次にセーフティ部材４０がグリップ１８の先端から突出する。なおカテーテル操作部材６０（カテーテル１２、カテーテルハブ２０）の進出操作時に、ユーザは、カテーテル操作部材６０に対してグリップ１８を相対的に後退する操作を行ってもよい。カテーテル操作部材６０をさらに進出させるとセーフティ部材４０の基端部がグリップ１８の移動限界（進出位置）に移動する。この際、セーフティ部材４０は、その先端がグリップ１８から露出して内針１４の先端よりも進出して内針１４を覆うことで、誤刺防止機能を発動する。 As shown in FIG. 3B, the catheter 12 and the catheter hub 20 are pulled out from the tip of the grip 18 by the above-mentioned advance operation, and then the safety member 40 is projected from the tip of the grip 18. When the catheter operating member 60 (catheter 12, catheter hub 20) is advanced, the user may perform an operation of retracting the grip 18 relative to the catheter operating member 60. When the catheter operating member 60 is further advanced, the base end portion of the safety member 40 moves to the movement limit (advance position) of the grip 18. At this time, the safety member 40 activates the erroneous puncture prevention function by exposing the tip of the safety member 40 from the grip 18 and advancing beyond the tip of the inner needle 14 to cover the inner needle 14.
　セーフティ部材４０は、進出位置において、グリップ１８から抜け出ずに先端方向及び基端方向への移動が停止した係止状態となる。これによりカテーテル１２、カテーテルハブ２０及びカテーテル操作部材６０をさらに進出させると、セーフティ部材４０がこれらの部材から離脱する。 At the advanced position, the safety member 40 is in a locked state in which movement in the distal end direction and the proximal end direction is stopped without coming out of the grip 18. As a result, when the catheter 12, the catheter hub 20, and the catheter operating member 60 are further advanced, the safety member 40 is separated from these members.
　そして図４Ａに示すように、カテーテル組立体１０は、カテーテル操作部材６０とセーフティ部材４０が分離することで、カテーテル操作部材６０とカテーテルハブ２０の係合が解除可能となる。このため、カテーテル１２及びカテーテルハブ２０は、カテーテル操作部材６０の下方から離脱される。 Then, as shown in FIG. 4A, in the catheter assembly 10, the catheter operating member 60 and the safety member 40 are separated from each other, so that the catheter operating member 60 and the catheter hub 20 can be disengaged from each other. Therefore, the catheter 12 and the catheter hub 20 are separated from the lower part of the catheter operating member 60.
　図４Ｂに示すように、カテーテル１２及びカテーテルハブ２０は、カテーテル操作部材６０から外れた形態となって、処置対象に留置される。留置前には、カテーテルハブ２０の弁部材２２が取り外されて、他の医療機器のコネクタ（不図示）が接続される。一方、内針１４、内針ハブ３０、セーフティ部材４０及びグリップ１８は一体化したままユーザにより適宜廃棄される。以下、上記動作を実施するカテーテル組立体１０の各構成について、具体的に説明していく。 As shown in FIG. 4B, the catheter 12 and the catheter hub 20 are placed in the treatment target in a form detached from the catheter operating member 60. Prior to indwelling, the valve member 22 of the catheter hub 20 is removed and a connector (not shown) of another medical device is connected. On the other hand, the inner needle 14, the inner needle hub 30, the safety member 40, and the grip 18 are appropriately discarded by the user while being integrated. Hereinafter, each configuration of the catheter assembly 10 that carries out the above operation will be specifically described.
　図１、図２及び図５に示すように、カテーテル組立体１０のカテーテル１２は、適度な可撓性を有する管体に構成されている。カテーテル１２の内部には矢印Ａ方向（軸方向）に貫通する内腔１２ａが設けられている。内腔１２ａは、内針１４を収容可能且つ薬液や血液等を流通可能な直径に設定されている。カテーテル１２の長さは、用途や諸条件等に応じて適宜設計可能であり、例えば１４～５００ｍｍ程度に設定され、好ましくは３０～４００ｍｍの範囲内に設定され、より好ましくは７６～２００ｍｍの範囲内に設定される。 As shown in FIGS. 1, 2 and 5, the catheter 12 of the catheter assembly 10 is formed of a tubular body having appropriate flexibility. A lumen 12a penetrating in the direction of arrow A (axial direction) is provided inside the catheter 12. The inner cavity 12a is set to a diameter capable of accommodating the inner needle 14 and allowing the drug solution, blood, and the like to flow. The length of the catheter 12 can be appropriately designed according to the application, various conditions, etc., and is set to, for example, about 14 to 500 mm, preferably within the range of 30 to 400 mm, and more preferably in the range of 76 to 200 mm. Set in.
　カテーテル１２の構成材料は、軟質樹脂材料が好適であり、例えば、ポリテトラフルオロエチレン（ＰＴＦＥ）、エチレン・テトラフルオロエチレン共重合体（ＥＴＦＥ）、ペルフルオロアルコキシフッ素樹脂（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又はこれらの混合物、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、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あげられる。 A soft resin material is preferable as the constituent material of the catheter 12, and for example, a fluororesin such as polytetrafluoroethylene (PTFE), ethylene / tetrafluoroethylene copolymer (ETFE), perfluoroalkoxy alkane resin (PFA), etc. Examples thereof include olefin resins such as polyethylene and polypropylene or mixtures thereof, polyurethanes, polyesters, polyamides, polyether nylon resins, and mixtures of olefin resins with ethylene / vinyl acetate copolymers.
　カテーテル１２の外周面には、処置対象に対するカテーテル１２の挿入抵抗（刺通抵抗）を低減するコーティング材１３が塗布されている。例えば、コーティング材１３は、カテーテル１２の周方向全体、且つカテーテル１２の先端から基端側（矢印Ａ２側）に向かってカテーテル１２の全長の２／３以上に塗布されていることが好ましい。また、コーティング材１３は、カテーテル１２の先端から露出されている内針１４の針先１５にも塗布されている。なお、コーティング材１３は、カテーテル１２の内腔１２ａを構成する内周面にも塗布されていてもよく、また内針１４の外周面に塗布されていてもよい。 The outer peripheral surface of the catheter 12 is coated with a coating material 13 that reduces the insertion resistance (penetration resistance) of the catheter 12 with respect to the treatment target. For example, it is preferable that the coating material 13 is applied to the entire circumferential direction of the catheter 12 and to 2/3 or more of the total length of the catheter 12 from the tip end side to the proximal end side (arrow A2 side) of the catheter 12. The coating material 13 is also applied to the needle tip 15 of the inner needle 14 exposed from the tip of the catheter 12. The coating material 13 may be applied to the inner peripheral surface forming the lumen 12a of the catheter 12, or may be applied to the outer peripheral surface of the inner needle 14.
　コーティング材１３を構成する材料は、カテーテル１２の潤滑性を高めることが可能であれば特に限定されず、例えば摩擦抵抗を低減可能なシリコーンや無水マレイン酸系ポリマー、アクリル酸系ポリマー、スルホベタイン系ポリマー等の材料を適用するとよい。また、カテーテル組立体１０は、コーティング材１３として親水性、撥水性、抗菌性又は抗血栓性を高める材料を適用することもできる。 The material constituting the coating material 13 is not particularly limited as long as it can improve the lubricity of the catheter 12, and for example, silicone, maleic anhydride-based polymer, acrylic acid-based polymer, and sulfobetaine-based material that can reduce frictional resistance. A material such as a polymer may be applied. Further, the catheter assembly 10 can be coated with a material that enhances hydrophilicity, water repellency, antibacterial property or antithrombotic property as the coating material 13.
　カテーテル１２の基端部は、かしめ、融着、接着等の適宜の固着手段により、カテーテルハブ２０内の先端部に固着される。カテーテルハブ２０は、カテーテル１２が処置対象の血管内に挿入された状態で処置対象の皮膚上に露出され、テープ等により貼り付けられてカテーテル１２と共に留置される。 The base end portion of the catheter 12 is fixed to the tip end portion in the catheter hub 20 by an appropriate fixing means such as caulking, fusion, and adhesion. The catheter hub 20 is exposed on the skin of the treatment target with the catheter 12 inserted into the blood vessel of the treatment target, and is attached with tape or the like and placed together with the catheter 12.
　カテーテルハブ２０は、矢印Ａ１側（先端方向）に向かって先細りとなる筒状に形成されている。カテーテルハブ２０の基端側外周面には、径方向外側に突出するフランジ部２１が連設されている。フランジ部２１は、他の医療機器が螺合可能な螺旋状を呈している。また、カテーテルハブ２０の内部には、カテーテル１２の内腔１２ａに連通して薬液や血液を流通可能な内部空間２０ａが設けられる。内部空間２０ａの基端は、カテーテルハブ２０の基端開口２０ａ１に連通している。 The catheter hub 20 is formed in a tubular shape that tapers toward the arrow A1 side (tip direction). Flange portions 21 projecting outward in the radial direction are continuously provided on the outer peripheral surface of the catheter hub 20 on the proximal end side. The flange portion 21 has a spiral shape that can be screwed into other medical devices. Further, inside the catheter hub 20, an internal space 20a is provided which communicates with the lumen 12a of the catheter 12 and allows the drug solution and blood to flow. The proximal end of the internal space 20a communicates with the proximal end opening 20a1 of the catheter hub 20.
　カテーテルハブ２０の構成材料は、特に限定されるものではないが、例えば、ポリプロピレン、ポリカーボネート、ポリアミド、ポリスルホン、ポリアリレート、メタクリレート・ブチレン・スチレン共重合体等の熱可塑性樹脂を適用するとよい。 The constituent material of the catheter hub 20 is not particularly limited, but for example, a thermoplastic resin such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, and a methacrylate / butylene / styrene copolymer may be applied.
　カテーテルハブ２０には、基端開口２０ａ１から内部空間２０ａの奥側（矢印Ａ１側）に向かって弁部材２２が挿入されている。弁部材２２は、カテーテルハブ２０に挿入される挿入部２３と、カテーテルハブ２０から露出される露出部２４とを有する。挿入部２３は、全体が弾性材料により構成され、矢印Ａ１側に向かって先細りとなるテーパ状に形成されている。挿入部２３の外周面は、カテーテルハブ２０の内周面に面接触可能である。 A valve member 22 is inserted into the catheter hub 20 from the base end opening 20a1 toward the back side (arrow A1 side) of the internal space 20a. The valve member 22 has an insertion portion 23 that is inserted into the catheter hub 20 and an exposed portion 24 that is exposed from the catheter hub 20. The insertion portion 23 is entirely made of an elastic material, and is formed in a tapered shape that tapers toward the arrow A1 side. The outer peripheral surface of the insertion portion 23 is in surface contact with the inner peripheral surface of the catheter hub 20.
　露出部２４は、挿入部２３の基端に連なり、この挿入部２３に一体成形される弾性部２４ａと、弾性部２４ａの外側を環状に覆う硬質部２４ｂとを有する円盤状に形成されている。露出部２４の径方向外側は、カテーテルハブ２０と弁部材２２の組立状態で、フランジ部２１と同程度突出している。挿入部２３及び露出部２４の軸心には、弾力的に開閉可能な弁孔２５が設けられている。弁部材２２は、穿刺前状態で、内針１４及びセーフティ部材４０の先端が弁孔２５に挿入されて、弁孔２５の内面とセーフティ部材４０の外面が密着する。これにより弁部材２２は、カテーテルハブ２０とセーフティ部材４０を嵌合状態とし、また内針１４の穿刺時に血液の漏れを防止する。 The exposed portion 24 is formed in a disk shape which is connected to the base end of the insertion portion 23 and has an elastic portion 24a integrally formed with the insertion portion 23 and a hard portion 24b which covers the outside of the elastic portion 24a in an annular shape. .. The radial outer side of the exposed portion 24 protrudes to the same extent as the flange portion 21 in the assembled state of the catheter hub 20 and the valve member 22. A valve hole 25 that can be elastically opened and closed is provided at the axial center of the insertion portion 23 and the exposed portion 24. In the valve member 22, the inner needle 14 and the tip of the safety member 40 are inserted into the valve hole 25 in the state before puncture, and the inner surface of the valve hole 25 and the outer surface of the safety member 40 are in close contact with each other. As a result, the valve member 22 puts the catheter hub 20 and the safety member 40 in a fitted state, and prevents blood from leaking when the inner needle 14 is punctured.
　一方、カテーテル組立体１０の内針１４は、生体の皮膚を穿刺可能な剛性を有する中空状の管体に構成される。内針１４の先端には鋭利な針先１５が形成されている。内針１４の内部には矢印Ａ方向に沿って中空部１４ａが貫通形成され、この中空部１４ａは、針先１５に設けられた先端開口１４ａ１と、内針１４の基端に設けられた基端開口１４ａ２とに連通している。また、針先１５から矢印Ａ２側に多少離れた位置には、内針１４の外部と中空部１４ａを連通する横孔１４ａ３が設けられている。 On the other hand, the inner needle 14 of the catheter assembly 10 is formed of a hollow tube body having rigidity capable of puncturing the skin of a living body. A sharp needle tip 15 is formed at the tip of the inner needle 14. A hollow portion 14a is formed through the inside of the inner needle 14 along the direction of the arrow A, and the hollow portion 14a has a tip opening 14a1 provided at the needle tip 15 and a base provided at the base end of the inner needle 14. It communicates with the end opening 14a2. Further, a lateral hole 14a3 for communicating the outside of the inner needle 14 and the hollow portion 14a is provided at a position slightly distant from the needle tip 15 on the arrow A2 side.
　内針１４の構成材料としては、例えば、ステンレス鋼、アルミニウム又はアルミニウム合金、チタン又はチタン合金のような金属材料、あるいは硬質樹脂、セラミックス等があげられる。内針１４は、融着、接着、インサート成形等の適宜の固着手段により、内針ハブ３０に強固に固着される。 Examples of the constituent material of the inner needle 14 include stainless steel, aluminum or aluminum alloy, metal material such as titanium or titanium alloy, hard resin, ceramics and the like. The inner needle 14 is firmly fixed to the inner needle hub 30 by appropriate fixing means such as fusion, adhesion, and insert molding.
　図２、図５、図６Ａ及び図６Ｂに示すように、内針ハブ３０は、グリップ１８に固定されるグリップ固定部３１と、グリップ固定部３１から上方向（矢印Ｃ１側）に突出して内針１４を直接保持する保持枠部３２とを有する。グリップ固定部３１は、グリップ１８の収容空間１８ａに挿入される幅で、且つグリップ１８の底壁９１に沿うように幅方向中央部が下側に窪む断面円弧状に形成されている。グリップ固定部３１の下面には、下方向に向かって短く突出し、グリップ１８との間で取付機構３３を構成する複数（本実施形態では３つ）の固定用凸部３４が設けられている。 As shown in FIGS. 2, 5, 6A and 6B, the inner needle hub 30 has a grip fixing portion 31 fixed to the grip 18 and an inner needle hub 30 projecting upward (arrow C1 side) from the grip fixing portion 31. It has a holding frame portion 32 that directly holds the needle 14. The grip fixing portion 31 has a width that is inserted into the accommodation space 18a of the grip 18, and is formed in an arcuate cross-section in which the central portion in the width direction is recessed downward along the bottom wall 91 of the grip 18. On the lower surface of the grip fixing portion 31, a plurality of (three in the present embodiment) fixing convex portions 34 that project downward shortly and form a mounting mechanism 33 with the grip 18 are provided.
　複数の固定用凸部３４には、グリップ固定部３１の矢印Ａ方向先端側に位置して幅方向に並ぶ一対の先端固定用凸部３４ａと、グリップ固定部３１の矢印Ａ方向中間に位置する中間固定用凸部３４ｂとが含まれる。一対の先端固定用凸部３４ａは、略立方形状のブロックに形成される一方で、中間固定用凸部３４ｂは、矢印Ａ方向に長い略直方形状のブロックに形成される。 The plurality of fixing convex portions 34 are located in the middle of a pair of tip fixing convex portions 34a located on the tip side of the grip fixing portion 31 in the arrow A direction and arranged in the width direction, and the grip fixing portion 31 in the arrow A direction. An intermediate fixing convex portion 34b is included. The pair of tip fixing convex portions 34a are formed in a substantially cubic block, while the intermediate fixing convex portion 34b is formed in a substantially rectangular block long in the arrow A direction.
　また、保持枠部３２は、矢印Ａ方向に所定長さ延在して内針１４を固着する筒状部３５を先端側に有する。筒状部３５は、内針１４が挿入される孔部３５ａを軸心に有する。保持枠部３２は、グリップ固定部３１の上面から突出して矢印Ａ方向に延在する複数の枠板３６を介して筒状部３５を支持している。各枠板３６は、筒状部３５を浮かせることで、後記の鈍針ハブ５１がスライド可能な空間を形成している。また保持枠部３２において筒状部３５よりも基端側は、鈍針ハブ５１のスライド範囲を規定する空間を構成している。 Further, the holding frame portion 32 has a tubular portion 35 on the tip side that extends in the direction of arrow A for a predetermined length and fixes the inner needle 14. The tubular portion 35 has a hole portion 35a into which the inner needle 14 is inserted as an axial center. The holding frame portion 32 supports the tubular portion 35 via a plurality of frame plates 36 protruding from the upper surface of the grip fixing portion 31 and extending in the direction of arrow A. Each frame plate 36 forms a space in which the blunt needle hub 51 described later can slide by floating the tubular portion 35. Further, the base end side of the holding frame portion 32 with respect to the tubular portion 35 constitutes a space that defines the slide range of the blunt needle hub 51.
　図２、図５、図７Ａ及び図７Ｂに示すように、セーフティ部材４０は、カテーテルハブ２０（弁部材２２）に挿入及び嵌合されることで、移動過程のカテーテルハブ２０に追従するように構成される。このセーフティ部材４０は、進出に伴って内針１４の外側を覆うカバー体４１と、穿刺後に内針１４の針先１５から突出する鈍針５０と、鈍針５０を保持する鈍針ハブ５１とを備える。 As shown in FIGS. 2, 5, 7A and 7B, the safety member 40 is inserted and fitted into the catheter hub 20 (valve member 22) so as to follow the catheter hub 20 in the moving process. It is composed. The safety member 40 includes a cover body 41 that covers the outside of the inner needle 14 as it advances, a blunt needle 50 that protrudes from the needle tip 15 of the inner needle 14 after puncture, and a blunt needle hub 51 that holds the blunt needle 50. To be equipped.
　カバー体４１は、矢印Ａ１側に位置する先端カバー部４２と、先端カバー部４２の上部に連結されて矢印Ａ２側に向かって所定長さ延在する基端延在部４３と、基端延在部４３から幅方向外側に突出する一対の突出部４４とを有する。また、基端延在部４３の矢印Ａ１側（先端カバー部４２の連結箇所）には、鈍針ハブ５１が係合する係合用突部４５が設けられている。 The cover body 41 includes a tip cover portion 42 located on the arrow A1 side, a base end extension portion 43 connected to the upper portion of the tip cover portion 42 and extending a predetermined length toward the arrow A2 side, and a base end extension. It has a pair of projecting portions 44 projecting outward in the width direction from the existing portion 43. Further, an engaging protrusion 45 with which the blunt needle hub 51 is engaged is provided on the arrow A1 side (connecting portion of the tip cover portion 42) of the base end extending portion 43.
　先端カバー部４２は、内針１４を収容可能な保護空間４２ａが貫通形成された円筒状に構成されている。先端カバー部４２は、先端側が細い筒状に形成され、基端側が先端側よりも太い筒状に形成されている。先端カバー部４２の先端側の外周面は、穿刺前状態において弁部材２２に挿入及び密着されることで、弁部材２２を含むカテーテルハブ２０に摩擦嵌合される。また穿刺前状態において、先端カバー部４２の基端は、内針ハブ３０の保持枠部３２の先端に対向している。そして、カバー体４１は、グリップ１８によりカバー体４１の移動が規制された進出位置において、先端カバー部４２の最先端よりも基端側に針先１５が位置するように設計されている。 The tip cover portion 42 is formed in a cylindrical shape through which a protective space 42a capable of accommodating the inner needle 14 is formed. The tip cover portion 42 is formed in a thin tubular shape on the tip side and a thicker tubular shape on the base end side than the tip side. The outer peripheral surface of the tip cover portion 42 on the tip end side is inserted and brought into close contact with the valve member 22 in the state before puncture, so that the outer peripheral surface is frictionally fitted to the catheter hub 20 including the valve member 22. Further, in the pre-puncture state, the base end of the tip cover portion 42 faces the tip of the holding frame portion 32 of the inner needle hub 30. The cover body 41 is designed so that the needle tip 15 is located closer to the base end side than the tip end of the tip cover portion 42 at the advance position where the movement of the cover body 41 is restricted by the grip 18.
　基端延在部４３は、先端カバー部４２との連結箇所において上方向に突出する連結部４３ａと、連結部４３ａから基端側に延在し且つ連結部４３ａよりも若干幅広に形成された板部４３ｂとを有する。連結部４３ａは、先端カバー部４２を吊り下げることで、その高さ（矢印Ｃ方向）位置を規定する。また板部４３ｂは、セーフティ部材４０を上下方向や幅方向に変形させない剛性とする厚みを持っている。この板部４３ｂは、穿刺前状態で、内針ハブ３０（保持枠部３２）の上部に沿ってグリップ１８内の基端まで延在している。 The base end extending portion 43 is formed so as to have a connecting portion 43a projecting upward at the connecting portion with the tip cover portion 42 and extending from the connecting portion 43a to the base end side and slightly wider than the connecting portion 43a. It has a plate portion 43b. The height (arrow C direction) of the connecting portion 43a is defined by suspending the tip cover portion 42. Further, the plate portion 43b has a thickness that makes the safety member 40 rigid so as not to be deformed in the vertical direction or the width direction. The plate portion 43b extends along the upper portion of the inner needle hub 30 (holding frame portion 32) to the base end in the grip 18 in the state before puncture.
　一対の突出部４４は、基端延在部４３よりも薄い板状に形成され、基端延在部４３の矢印Ａ方向中間部から基端までの間を延在している。各突出部４４は、幅方向（矢印Ｂ方向）外側に向かって内針ハブ３０（グリップ固定部３１）よりも突出し、グリップ１８の側壁７７の近傍位置まで延在している（図１２も参照）。各突出部４４は、セーフティ部材４０の移動においてグリップ１８と協働して矢印Ａ方向にガイドを行うガイド機構４６を構成している。 The pair of projecting portions 44 are formed in a plate shape thinner than the proximal end extending portion 43, and extend from the intermediate portion in the arrow A direction of the proximal end extending portion 43 to the proximal end. Each protrusion 44 projects outward from the inner needle hub 30 (grip fixing portion 31) in the width direction (arrow B direction) and extends to a position near the side wall 77 of the grip 18 (see also FIG. 12). ). Each protrusion 44 constitutes a guide mechanism 46 that guides the safety member 40 in the direction of arrow A in cooperation with the grip 18.
　また、一対の突出部４４のうち一方（矢印Ｂ１側）の突出部４４には、矢印Ｃ２側に突出し、且つ矢印Ａ方向に沿って延在する被ガイド突部４７が設けられている。被ガイド突部４７は、ガイド機構４６の一部を構成し、グリップ１８（下グリップ９０）の矢印Ｂ１側の下部側壁９２よりも内側に配置されることで、セーフティ部材４０の幅方向のずれを防止する。 Further, one of the pair of protrusions 44 (the arrow B1 side) of the protrusion 44 is provided with a guided protrusion 47 that protrudes toward the arrow C2 and extends along the direction of the arrow A. The guided protrusion 47 constitutes a part of the guide mechanism 46 and is arranged inside the lower side wall 92 on the arrow B1 side of the grip 18 (lower grip 90), so that the safety member 40 is displaced in the width direction. To prevent.
　さらに、矢印Ｂ１側の突出部４４は、被ガイド突部４７よりも矢印Ｂ１側（幅方向外側）、且つ当該突出部４４の矢印Ａ２側に被係止凸部４８を有する。被係止凸部４８は、セーフティ部材４０が進出した進出位置においてグリップ１８の係止部１０９に係止されることで、カバー体４１の進出及び後退を制限するセーフティ移動制限機構部４９の一方を構成する。この被係止凸部４８については後に詳述する。 Further, the protruding portion 44 on the arrow B1 side has a locked convex portion 48 on the arrow B1 side (outside in the width direction) of the guided protrusion 47 and on the arrow A2 side of the protruding portion 44. The locked convex portion 48 is locked to the locking portion 109 of the grip 18 at the advanced position where the safety member 40 has advanced, so that one of the safety movement limiting mechanism portions 49 that restricts the advancement and retreat of the cover body 41. To configure. The locked convex portion 48 will be described in detail later.
　セーフティ部材４０の鈍針５０は、カテーテル１２や生体に対して内針１４が穿刺不能となるように構成された棒部材（丸棒）であり、内針１４の中空部１４ａに移動可能に収容される。鈍針５０の先端は、内針１４の針先１５よりも鈍らな形状（例えば、研磨した平坦面）に形成され、穿刺前状態で、内針１４の中空部１４ａにおける横孔１４ａ３の基端近傍位置に配置されている。 The blunt needle 50 of the safety member 40 is a rod member (round bar) configured so that the inner needle 14 cannot puncture the catheter 12 or the living body, and is movably housed in the hollow portion 14a of the inner needle 14. Will be done. The tip of the blunt needle 50 is formed in a shape blunter than the needle tip 15 of the inner needle 14 (for example, a polished flat surface), and the base end of the lateral hole 14a3 in the hollow portion 14a of the inner needle 14 in the state before puncture. It is located in the vicinity.
　すなわち、鈍針５０は、穿刺前状態で、カテーテル１２及び内針１４と共に多重管１１を構成している。そして、セーフティ部材４０の進出に伴って鈍針５０の先端が針先１５から露出される。鈍針５０の太さは、内針１４の中空部１４ａの直径よりも僅かに小径であるとよく、例えば外径が０．１９ｍｍ～１．１９ｍｍ程度の範囲に設定されるとよい。鈍針５０を構成する材料は、充分な硬質性が得られれば特に限定されるものではなく、例えば、ステンレス鋼、Ｎｉ－Ｔｉ系合金のような超弾性合金、形状記憶合金、コバルト系合金、金、白金のような貴金属、タングステン系合金等の金属材料、又は所定硬度以上の樹脂材料があげられる。 That is, the blunt needle 50 constitutes the multiple tube 11 together with the catheter 12 and the inner needle 14 in the state before puncture. Then, as the safety member 40 advances, the tip of the blunt needle 50 is exposed from the needle tip 15. The thickness of the blunt needle 50 may be slightly smaller than the diameter of the hollow portion 14a of the inner needle 14, and for example, the outer diameter may be set in the range of about 0.19 mm to 1.19 mm. The material constituting the blunt needle 50 is not particularly limited as long as sufficient hardness can be obtained, and for example, stainless steel, superelastic alloys such as Ni—Ti alloys, shape memory alloys, cobalt alloys, etc. Examples thereof include precious metals such as gold and platinum, metal materials such as tungsten alloys, and resin materials having a predetermined hardness or higher.
　また、鈍針ハブ５１は、鈍針５０を固定及び保持し、カバー体４１に係合することで内針１４、内針ハブ３０及びグリップ１８に対して相対移動可能に構成される。この鈍針ハブ５１の進退に追従して鈍針５０が進退する。鈍針ハブ５１は、鈍針５０を保持する鈍針保持部５２と、鈍針保持部５２の基端から先端方向に延在するアーム部５３とを有する。 Further, the blunt needle hub 51 is configured to be movable relative to the inner needle 14, the inner needle hub 30, and the grip 18 by fixing and holding the blunt needle 50 and engaging with the cover body 41. The blunt needle 50 advances and retreats following the advance and retreat of the blunt needle hub 51. The blunt needle hub 51 has a blunt needle holding portion 52 for holding the blunt needle 50, and an arm portion 53 extending from the base end of the blunt needle holding portion 52 toward the tip end.
　鈍針保持部５２は、上下方向に所定高さを有するブロック状に構成され、その上部において鈍針５０の基端側を固定している。鈍針保持部５２は、穿刺前状態で、保持枠部３２の筒状部３５よりも基端側の空間に配置される。そのため、鈍針ハブ５１は、内針ハブ３０に対して進出し、鈍針保持部５２の先端面が筒状部３５の基端面に接触すると、以降の鈍針ハブ５１の進出が阻止される。 The blunt needle holding portion 52 is formed in a block shape having a predetermined height in the vertical direction, and the base end side of the blunt needle 50 is fixed at the upper portion thereof. The blunt needle holding portion 52 is arranged in a space on the base end side of the holding frame portion 32 with respect to the tubular portion 35 in the state before puncture. Therefore, the blunt needle hub 51 advances with respect to the inner needle hub 30, and when the tip end surface of the blunt needle holding portion 52 comes into contact with the base end surface of the tubular portion 35, the subsequent advancement of the blunt needle hub 51 is prevented. ..
　アーム部５３は、鈍針保持部５２から矢印Ａ１側に所定長さ延在しており、延在部分全体が幅方向に弾性変形可能に構成されている。アーム部５３の先端には、穿刺前状態でカバー体４１の係合用突部４５に係合する係合部５４が設けられている。係合部５４は、先端部に位置する傾斜部５５と、傾斜部５５よりもさらに矢印Ａ１側に短く突出して傾斜部５５との間で係合用突部４５を挟み込むフック部５６とにより構成される。 The arm portion 53 extends from the blunt needle holding portion 52 to the arrow A1 side by a predetermined length, and the entire extending portion is configured to be elastically deformable in the width direction. At the tip of the arm portion 53, an engaging portion 54 that engages with the engaging protrusion 45 of the cover body 41 before puncturing is provided. The engaging portion 54 is composed of an inclined portion 55 located at the tip portion and a hook portion 56 that projects shorter toward the arrow A1 side than the inclined portion 55 and sandwiches the engaging protrusion 45 between the inclined portion 55. The arrow.
　傾斜部５５は、矢印Ａ１側且つ矢印Ｂ１側（幅方向内側）に向かって突出している。カバー体４１の係合用突部４５は、平面断面視で傾斜部５５の傾斜に沿った三角形状に形成されており傾斜部５５の傾斜にガイドされる。フック部５６は、傾斜部５５の連結箇所から矢印Ａ１側に突出する板片５６ａと、板片５６ａの先端から矢印Ｂ１側に短く突出して傾斜部５５との間で係合用突部４５を囲う（引っ掛かる）凸部５６ｂとを含む。フック部５６の板片５６ａは、鈍針ハブ５１の移動が制限された段階（鈍針保持部５２が筒状部３５に当接した段階）で、カバー体４１が進出すると幅方向外側に弾性変形して、凸部５６ｂと係合用突部４５の引っ掛かりを解除する。 The inclined portion 55 projects toward the arrow A1 side and the arrow B1 side (inside in the width direction). The engaging protrusion 45 of the cover body 41 is formed in a triangular shape along the inclination of the inclined portion 55 in a plan sectional view, and is guided by the inclination of the inclined portion 55. The hook portion 56 surrounds the engaging protrusion 45 between the plate piece 56a projecting from the connecting portion of the inclined portion 55 toward the arrow A1 and the plate piece 56a protruding shortly toward the arrow B1 from the tip of the plate piece 56a. Includes a convex portion 56b (to be caught). The plate piece 56a of the hook portion 56 is elastic outward in the width direction when the cover body 41 advances at the stage where the movement of the blunt needle hub 51 is restricted (the stage where the blunt needle holding portion 52 abuts on the tubular portion 35). It is deformed to release the hook between the convex portion 56b and the engaging protrusion 45.
　なお、セーフティ部材４０は、内針１４の針先１５の誤刺を防止できれば、上記の構成に限定されるものではない。例えば、セーフティ部材４０は、鈍針５０や鈍針ハブ５１を備えずカバー体４１のみで構成されてもよい。 The safety member 40 is not limited to the above configuration as long as it can prevent the needle tip 15 of the inner needle 14 from being erroneously stabbed. For example, the safety member 40 may be composed of only the cover body 41 without the blunt needle 50 or the blunt needle hub 51.
　図２、図５及び図８に示すように、カテーテル操作部材６０は、ユーザの操作に基づきカテーテル１２、カテーテルハブ２０及びセーフティ部材４０を進退させる部材である。カテーテル操作部材６０は、グリップ１８の長手方向（矢印Ａ方向）に延在する操作板部６１と、操作板部６１の基端に連なりカテーテルハブ２０を収容するハブ収容部６２と、ハブ収容部６２の基端に連なりセーフティ部材４０を収容する操作部筒部６３とを有する。 As shown in FIGS. 2, 5 and 8, the catheter operating member 60 is a member that advances and retreats the catheter 12, the catheter hub 20, and the safety member 40 based on the user's operation. The catheter operating member 60 includes an operating plate portion 61 extending in the longitudinal direction of the grip 18 (direction of arrow A), a hub accommodating portion 62 connected to the base end of the operating plate portion 61 and accommodating the catheter hub 20, and a hub accommodating portion. It has an operation unit tubular portion 63 connected to the base end of 62 and accommodating the safety member 40.
　操作板部６１は、ユーザの指が当てられて進退操作がなされる部位である。操作板部６１の上面には、複数のタブ６４が設けられている。複数のタブ６４のうち最も先端のタブ６４ａは、他のタブ６４よりも突出することでカテーテル操作部材６０をユーザの指により押し出し易くしている。また、操作板部６１は、薄肉に形成されることで、多重管１１から離れる方向に湾曲可能な可撓性を有する。操作板部６１の一対の側縁６１ａは、穿刺前状態で、後記するグリップ１８の一対のレール壁９６、９８上に配置される。操作板部６１（カテーテル操作部材６０）を構成する材料は、特に限定されるものではなく、例えば、カテーテルハブ２０であげた材料を適宜選択し得る。 The operation plate portion 61 is a portion where a user's finger is touched to perform an advance / retreat operation. A plurality of tabs 64 are provided on the upper surface of the operation plate portion 61. The most advanced tab 64a of the plurality of tabs 64 projects more than the other tabs 64, making it easier for the user's finger to push out the catheter operating member 60. Further, since the operation plate portion 61 is formed to be thin, it has flexibility that can be bent in a direction away from the multi-layer tube 11. The pair of side edges 61a of the operation plate portion 61 are arranged on the pair of rail walls 96 and 98 of the grip 18 described later in the state before puncture. The material constituting the operation plate portion 61 (catheter operation member 60) is not particularly limited, and for example, the material mentioned in the catheter hub 20 can be appropriately selected.
　操作板部６１の先端には、矢印Ａ１側に向かって矢印Ｃ１側に反った凹状ブロック６５が設けられている。この凹状ブロック６５の下面且つ幅方向中央には、穿刺状態でカテーテル１２が配置される溝６５ａが設けられている。溝６５ａの幅は、カテーテル１２の外径よりも若干広く形成されている。また操作板部６１の下面には、カテーテル１２に接触可能な複数のリブ６６が設けられている。 At the tip of the operation plate portion 61, a concave block 65 that warps toward the arrow C1 side toward the arrow A1 side is provided. A groove 65a in which the catheter 12 is arranged in a punctured state is provided on the lower surface of the concave block 65 and in the center in the width direction. The width of the groove 65a is formed to be slightly wider than the outer diameter of the catheter 12. Further, a plurality of ribs 66 that can come into contact with the catheter 12 are provided on the lower surface of the operation plate portion 61.
　一方、カテーテル操作部材６０のハブ収容部６２は、弁部材２２を含むカテーテルハブ２０を収容する収容室６２ａを内側に有すると共に、この収容室６２ａの下方を開放した箱状に形成されている。ハブ収容部６２は、グリップ１８の側壁７７よりも幅狭に形成され、カテーテル操作部材６０の移動において側壁７７により移動がガイドされる。ハブ収容部６２の先端面には、カテーテルハブ２０の直径よりも狭くカテーテル１２（多重管１１）のみを延出させる間隙６２ｂが設けられている。 On the other hand, the hub accommodating portion 62 of the catheter operating member 60 has an accommodating chamber 62a for accommodating the catheter hub 20 including the valve member 22 inside, and is formed in a box shape in which the lower part of the accommodating chamber 62a is opened. The hub accommodating portion 62 is formed to be narrower than the side wall 77 of the grip 18, and the movement is guided by the side wall 77 in the movement of the catheter operating member 60. A gap 62b is provided on the tip surface of the hub accommodating portion 62 so as to extend only the catheter 12 (multiple tube 11) narrower than the diameter of the catheter hub 20.
　操作部筒部６３は、ハブ収容部６２の基端面から基端方向に向かって所定長さ突出する円筒状に形成されている。この操作部筒部６３の内側にはハブ収容部６２の収容室６２ａに連通する挿通空間６３ａが設けられている。挿通空間６３ａは、操作部筒部６３内を軸方向に貫通形成され、セーフティ部材４０（カバー体４１）の先端カバー部４２が挿通される。また、操作部筒部６３の外周面には、周方向に突出形成されて操作部筒部６３を補強する円弧状リブ６７が設けられている。 The operation unit tubular portion 63 is formed in a cylindrical shape that protrudes from the proximal end surface of the hub accommodating portion 62 toward the proximal end by a predetermined length. An insertion space 63a communicating with the accommodation chamber 62a of the hub accommodation portion 62 is provided inside the operation unit cylinder portion 63. The insertion space 63a is formed so as to penetrate the inside of the operation portion tubular portion 63 in the axial direction, and the tip cover portion 42 of the safety member 40 (cover body 41) is inserted. Further, on the outer peripheral surface of the operating portion tubular portion 63, an arcuate rib 67 which is formed so as to project in the circumferential direction to reinforce the operating portion tubular portion 63 is provided.
　挿通空間６３ａの内径は、セーフティ部材４０（カバー体４１の先端カバー部４２）の外径Ｄよりも多少大きく、且つカテーテルハブ２０や弁部材２２の外径よりも小さく設定されている。このため、操作部筒部６３は、挿通されている先端カバー部４２の外径Ｄに対して余裕空間６３ａ１（図１２参照）を持つように構成される。これによりカテーテル操作部材６０に対してセーフティ部材４０が軸回りに回転自在となる。 The inner diameter of the insertion space 63a is set to be slightly larger than the outer diameter D of the safety member 40 (the tip cover portion 42 of the cover body 41) and smaller than the outer diameter of the catheter hub 20 and the valve member 22. Therefore, the operation unit cylinder portion 63 is configured to have a margin space 63a1 (see FIG. 12) with respect to the outer diameter D of the tip cover portion 42 to be inserted. As a result, the safety member 40 can rotate around the axis with respect to the catheter operating member 60.
　そして、操作部筒部６３は、当該操作部筒部６３の軸方向全長にわたって形成されたスリット６３ｂを有する。すなわちスリット６３ｂは、先端側において収容室６２ａに連通し、操作部筒部６３の最基端まで直線状に延在している。このスリット６３ｂは、操作部筒部６３の側方から挿通空間６３ａに内針１４を通過可能とする一方で、挿通空間６３ａから操作部筒部６３の側方への先端カバー部４２の通過を不能とする。 Then, the operation unit tubular portion 63 has a slit 63b formed over the entire axial length of the operation unit tubular portion 63. That is, the slit 63b communicates with the accommodating chamber 62a on the tip end side and extends linearly to the most basic end of the operation unit tubular portion 63. The slit 63b allows the inner needle 14 to pass from the side of the operation unit cylinder 63 to the insertion space 63a, while allowing the tip cover portion 42 to pass from the insertion space 63a to the side of the operation unit 63a. Make it impossible.
　具体的には、図８及び図１２に示すように、スリット６３ｂの幅Ｗは、断面円形状の内針１４の外径φよりも大きな寸法に設定されている。その一方で、スリット６３ｂの幅Ｗは、断面円形状の先端カバー部４２の外径Ｄよりも小さな寸法に設定されている。従って、内針１４の外径φ、セーフティ部材４０（先端カバー部４２の基端側）の外径Ｄ、スリット６３ｂの幅Ｗの寸法は、φ＜Ｗ＜Ｄの関係となっている。なお、スリット６３ｂの幅Ｗは、内針１４の外径φよりも若干小さく形成され、スリット６３ｂに内針１４を通過させる際に操作部筒部６３を弾性変形させる構成でもよい。 Specifically, as shown in FIGS. 8 and 12, the width W of the slit 63b is set to a dimension larger than the outer diameter φ of the inner needle 14 having a circular cross section. On the other hand, the width W of the slit 63b is set to be smaller than the outer diameter D of the tip cover portion 42 having a circular cross section. Therefore, the dimensions of the outer diameter φ of the inner needle 14, the outer diameter D of the safety member 40 (the base end side of the tip cover portion 42), and the width W of the slit 63b have a relationship of φ <W <D. The width W of the slit 63b may be formed to be slightly smaller than the outer diameter φ of the inner needle 14, and the operation unit tubular portion 63 may be elastically deformed when the inner needle 14 is passed through the slit 63b.
　また図５に示すように、操作部筒部６３は、セーフティ部材４０に対するカテーテル操作部材６０の曲がりを抑制するために、軸方向に沿った長さをある程度持つように構成される。詳細には、操作部筒部６３の軸方向長さＬは、カテーテルハブ２０を収容するハブ収容部６２の軸方向長さの１／３以上に設定されることが好ましい。これによりカテーテル操作部材６０の操作時に、カテーテル操作部材６０とセーフティ部材４０の直線性を良好に維持することができる。 Further, as shown in FIG. 5, the operation unit tubular portion 63 is configured to have a certain length along the axial direction in order to suppress bending of the catheter operating member 60 with respect to the safety member 40. Specifically, the axial length L of the operation unit tubular portion 63 is preferably set to 1/3 or more of the axial length of the hub accommodating portion 62 accommodating the catheter hub 20. As a result, when the catheter operating member 60 is operated, the linearity between the catheter operating member 60 and the safety member 40 can be maintained satisfactorily.
　図１に戻り、カテーテル組立体１０のグリップ１８は、ユーザが持ち易い適宜の太さに形成され、矢印Ａ方向に沿って所定長さ延在している。グリップ１８内には、カテーテル１２、カテーテルハブ２０、セーフティ部材４０及びカテーテル操作部材６０が進退可能な収容空間１８ａが形成されている。収容空間１８ａは、グリップ１８の先端開放部１８ｂに連通し、カテーテル１２、カテーテルハブ２０、セーフティ部材４０及びカテーテル操作部材６０を送出可能としている。グリップ１８は、矢印Ｃ方向（長手方向と直交する方向）に分割可能な上グリップ７０（第１部材）と、下グリップ９０（第２部材）とを相互に組み付けることで構成される。 Returning to FIG. 1, the grip 18 of the catheter assembly 10 is formed to have an appropriate thickness that is easy for the user to hold, and extends for a predetermined length along the direction of arrow A. A storage space 18a in which the catheter 12, the catheter hub 20, the safety member 40, and the catheter operating member 60 can advance and retreat is formed in the grip 18. The accommodation space 18a communicates with the tip opening portion 18b of the grip 18 so that the catheter 12, the catheter hub 20, the safety member 40, and the catheter operating member 60 can be delivered. The grip 18 is configured by mutually assembling an upper grip 70 (first member) and a lower grip 90 (second member) that can be divided in the arrow C direction (direction orthogonal to the longitudinal direction).
　図１、図２及び図９に示すように、上グリップ７０は、天井壁７１、一対の上部側壁７２及び上部後壁７３を有し、下方向に開放した凹形状（椀状）に形成されている。天井壁７１は、矢印Ａ方向中間部から基端にわたって上部を非露出とする被覆部７１ａを有する。被覆部７１ａは、断面視で円弧状に形成されている。被覆部７１ａの下面（内側）には、一対の上部側壁７２よりも下方向に短く突出して、矢印Ａ方向に延在する一対の突条部７４が設けられている。一対の突条部７４は、カバー体４１の上方においてカバー体４１（一対の突出部４４）の上面に近接し、カバー体４１の進退をガイドするガイド機構４６の一部を構成する（図１２も参照）。 As shown in FIGS. 1, 2 and 9, the upper grip 70 has a ceiling wall 71, a pair of upper side walls 72 and an upper rear wall 73, and is formed in a concave shape (bowl shape) open downward. ing. The ceiling wall 71 has a covering portion 71a whose upper portion is unexposed from the intermediate portion in the direction of arrow A to the base end. The covering portion 71a is formed in an arc shape in a cross-sectional view. On the lower surface (inside) of the covering portion 71a, a pair of ridge portions 74 projecting downward shorter than the pair of upper side walls 72 and extending in the direction of arrow A are provided. The pair of ridges 74 are close to the upper surface of the cover 41 (a pair of protrusions 44) above the cover 41, and form a part of a guide mechanism 46 that guides the advance / retreat of the cover 41 (FIG. 12). See also).
　一方、天井壁７１は、中間部よりも先端側において矢印Ｂ方向中央に操作部露出切り欠き７５が形成されていることで一対（二又）の延出部７６を有する。一対の上部側壁７２及び一対の突条部７４は、被覆部７１ａの基端から一対の延出部７６の略先端にわたって（後記の上突片部７８の基端まで）延在し、一対の延出部７６を補強している。 On the other hand, the ceiling wall 71 has a pair of (two-pronged) extending portions 76 because the operating portion exposed notch 75 is formed in the center in the arrow B direction on the tip side of the intermediate portion. The pair of upper side walls 72 and the pair of ridges 74 extend from the base end of the covering portion 71a to substantially the tip of the pair of extension portions 76 (to the base end of the upper protrusion piece portion 78 described later), and are paired. The extension portion 76 is reinforced.
　また、一対の上部側壁７２は、天井壁７１の側辺から下方向に突出することで、下グリップ９０の下部側壁９２と共にグリップ１８の側壁７７を構成する。矢印Ｂ１側の上部側壁７２は、各穿刺前状態において、カバー体４１の被係止凸部４８を内側に収容して被係止凸部４８を非露出とする。また、各上部側壁７２の先端側には、ユーザの把持をガイドする複数の上部窪み７２ａが形成されている。 Further, the pair of upper side walls 72 project downward from the side side of the ceiling wall 71 to form the side wall 77 of the grip 18 together with the lower side wall 92 of the lower grip 90. The upper side wall 72 on the arrow B1 side accommodates the locked convex portion 48 of the cover body 41 inside in each pre-puncture state, and the locked convex portion 48 is not exposed. Further, on the tip end side of each upper side wall 72, a plurality of upper recesses 72a for guiding the user's grip are formed.
　上グリップ７０の操作部露出切り欠き７５は、一対の突条部７４間により構成され、収容空間１８ａに連通している。操作部露出切り欠き７５は、カテーテル操作部材６０のタブ６４を進退可能に露出させる。操作部露出切り欠き７５は、先端において開放し、カテーテル操作部材６０（タブ６４）の進出及びグリップ１８からの離脱を可能としている。 The operation portion exposed notch 75 of the upper grip 70 is composed of a pair of ridge portions 74 and communicates with the accommodation space 18a. The operating portion exposed notch 75 exposes the tab 64 of the catheter operating member 60 so as to be able to advance and retreat. The operating portion exposed notch 75 is opened at the tip to allow the catheter operating member 60 (tab 64) to advance and detach from the grip 18.
　一対の延出部７６は、操作部露出切り欠き７５の両サイドを、被覆部７１ａから矢印Ａ１側に向かって徐々に低くなるように延在している。一対の延出部７６の各先端部には、略平坦状を呈すると共に、一対の上部側壁７２よりも幅方向外側に突出する上突片部７８が形成されている。一対の上突片部７８の下面には、上グリップ７０と下グリップ９０の固定機構７９の一部である先端固定用フック８０がそれぞれ設けられている。一対の先端固定用フック８０は、下方向に短く突出し、幅方向内側に突出する爪を突出端（下端）に備える。 The pair of extending portions 76 extend on both sides of the operating portion exposed notch 75 so as to gradually decrease from the covering portion 71a toward the arrow A1 side. Each tip of the pair of extending portions 76 is formed with an upper projecting piece portion 78 that is substantially flat and protrudes outward in the width direction from the pair of upper side walls 72. On the lower surface of the pair of upper protrusions 78, tip fixing hooks 80, which are a part of the fixing mechanism 79 of the upper grip 70 and the lower grip 90, are provided. The pair of tip fixing hooks 80 project shortly downward and have claws projecting inward in the width direction at the protruding end (lower end).
　また、矢印Ｂ１側の上突片部７８（以下、第１上突片部７８ａという）の下面には、上部側壁７２と同じ程度下方向に突出するブロック突部８１が形成されている。ブロック突部８１は、後述する下グリップ９０のセーフティ移動制限機構部４９（空間部１１０）の幅方向外側を部分的に覆い、進出位置に移動したセーフティ部材４０の被係止凸部４８を概ね非露出とする。さらに、第１上突片部７８ａのブロック突部８１よりも矢印Ａ１側の側面には、位置決め切り欠き８２が設けられている。一方、矢印Ｂ２側の上突片部７８（以下、第２上突片部７８ｂという）の下面には、後記の下支え部材１２０を軸支するための上軸受穴８３が設けられている。また第２上突片部７８ｂの矢印Ｂ２側の側面にも位置決め切り欠き８２が設けられている。 Further, on the lower surface of the upper projecting piece portion 78 on the arrow B1 side (hereinafter referred to as the first upper projecting piece portion 78a), a block projecting portion 81 projecting downward to the same extent as the upper side wall 72 is formed. The block protrusion 81 partially covers the outside of the safety movement limiting mechanism portion 49 (space portion 110) of the lower grip 90, which will be described later, in the width direction, and generally covers the locked convex portion 48 of the safety member 40 that has moved to the advanced position. Unexposed. Further, a positioning notch 82 is provided on the side surface of the first upper projecting piece portion 78a on the side of the arrow A1 side of the block projecting portion 81. On the other hand, an upper bearing hole 83 for axially supporting the lower support member 120 described later is provided on the lower surface of the upper projecting piece portion 78 (hereinafter referred to as the second upper projecting piece portion 78b) on the arrow B2 side. Further, a positioning notch 82 is also provided on the side surface of the second upper projecting piece portion 78b on the arrow B2 side.
　上グリップ７０の上部後壁７３は、矢印Ｃ２側に向かって一対の上部側壁７２よりも短く突出し、その先端面に一対の突条部７４が連結されている。この上部後壁７３の下面には、固定機構７９の一部を構成する基端固定用フック８４が設けられると共に、基端固定用フック８４の近傍位置（矢印Ａ２側且つ矢印Ｂ１側）に固定用突起８５が突出形成されている。基端固定用フック８４は、下方向に短く突出し、矢印Ａ１側に突出する爪を突出端（下端）に備える。 The upper rear wall 73 of the upper grip 70 projects shorter than the pair of upper side walls 72 toward the arrow C2 side, and the pair of ridges 74 are connected to the tip surface thereof. On the lower surface of the upper rear wall 73, a base end fixing hook 84 forming a part of the fixing mechanism 79 is provided and fixed at a position near the base end fixing hook 84 (arrow A2 side and arrow B1 side). The hook 85 is formed as a protrusion. The base end fixing hook 84 is provided with a claw that projects downward shortly and projects toward the arrow A1 side at the protruding end (lower end).
　図２、図５及び図１０に示すように、下グリップ９０は、底壁９１、一対の下部側壁９２及び下部後壁９３を有し、上方向に開放した凹形状（椀状）に形成されている。底壁９１の矢印Ａ１側の所定範囲は、幅方向中央が下側に窪む円弧状に形成され、カテーテルハブ２０の進退をガイドするガイド面９１ａとなっている。また底壁９１の矢印Ａ２側の所定範囲は、ガイド面９１ａと同形状であるものの当該ガイド面９１ａよりも低く形成され、内針ハブ３０が装着される被装着部９１ｂとなっている。 As shown in FIGS. 2, 5 and 10, the lower grip 90 has a bottom wall 91, a pair of lower side walls 92 and a lower rear wall 93, and is formed in a concave shape (bowl shape) open upward. ing. The predetermined range on the arrow A1 side of the bottom wall 91 is formed in an arc shape in which the center in the width direction is recessed downward, and is a guide surface 91a that guides the advance / retreat of the catheter hub 20. Further, the predetermined range on the arrow A2 side of the bottom wall 91 is formed to be lower than the guide surface 91a although it has the same shape as the guide surface 91a, and is a mounted portion 91b to which the inner needle hub 30 is mounted.
　図１１に示すように、被装着部９１ｂには、内針ハブ３０の固定用凸部３４を嵌合可能な複数（本実施形態では３つ）の装着孔９４が設けられている。具体的には複数の装着孔９４は、被装着部９１ｂの先端側において幅方向に２つ並ぶ一対の先端装着孔９４ａと、一対の先端装着孔９４ａから基端方向に所定間隔離間した位置に設けられる中間装着孔９４ｂとを含む。一対の先端装着孔９４ａは、矢印Ｂ方向に若干長い長方形状に形成され、中間装着孔９４ｂは、矢印Ａ方向に長い長孔に形成されている。 As shown in FIG. 11, the mounted portion 91b is provided with a plurality of mounting holes 94 (three in the present embodiment) into which the fixing convex portions 34 of the inner needle hub 30 can be fitted. Specifically, the plurality of mounting holes 94 are located at positions separated from the pair of tip mounting holes 94a arranged in the width direction on the tip side of the mounted portion 91b by a predetermined distance in the proximal direction. Includes an intermediate mounting hole 94b provided. The pair of tip mounting holes 94a are formed in a rectangular shape slightly long in the arrow B direction, and the intermediate mounting holes 94b are formed in a long hole long in the arrow A direction.
　すなわち、内針ハブ３０と下グリップ９０の装着では、内針ハブ３０を下グリップ９０の底壁９１に向けて移動する（単純に矢印Ｃ２側に入れ込む）。これにより、一対の先端固定用凸部３４ａを一対の先端装着孔９４ａに挿入すると共に、中間固定用凸部３４ｂを中間装着孔９４ｂに挿入して、各固定用凸部３４と各装着孔９４がそれぞれ強固に嵌合する。 That is, when the inner needle hub 30 and the lower grip 90 are attached, the inner needle hub 30 is moved toward the bottom wall 91 of the lower grip 90 (simply inserted into the arrow C2 side). As a result, the pair of tip fixing convex portions 34a are inserted into the pair of tip mounting holes 94a, and the intermediate fixing convex portions 34b are inserted into the intermediate mounting holes 94b, so that the fixing convex portions 34 and the respective mounting holes 94 are inserted. Are firmly fitted to each other.
　図２、図１０及び図１２に示すように、下グリップ９０の一対の下部側壁９２は、底壁９１の側辺から上方向（矢印Ｃ１側）に突出すると共に、矢印Ａ方向の略全体にわたって延在している。各下部側壁９２の先端側には、上部窪み７２ａに連なりユーザの把持をガイドする複数の下部窪み９２ａが形成されている。 As shown in FIGS. 2, 10 and 12, the pair of lower side walls 92 of the lower grip 90 project upward (arrow C1 side) from the side side of the bottom wall 91 and cover substantially the entire direction of arrow A. It is postponed. On the tip end side of each lower side wall 92, a plurality of lower recesses 92a that are connected to the upper recess 72a and guide the user's grip are formed.
　矢印Ｂ２側の下部側壁９２は、下部が厚壁９５に構成される一方で、厚壁９５の上部且つ内側（矢印Ｂ１側）に厚壁９５に連なるレール壁９６を有する。つまり下部側壁９２の上部且つ矢印Ｂ２側には、段差が形成されており、この段差部分には、組立状態でレール壁９６の側面に密着するように上グリップ７０の上部側壁７２が配置される。 The lower side wall 92 on the arrow B2 side has a rail wall 96 connected to the thick wall 95 on the upper side and inside (arrow B1 side) of the thick wall 95 while the lower portion is formed of the thick wall 95. That is, a step is formed on the upper part of the lower side wall 92 and on the arrow B2 side, and the upper side wall 72 of the upper grip 70 is arranged in this step portion so as to be in close contact with the side surface of the rail wall 96 in the assembled state. ..
　矢印Ｂ１側の下部側壁９２は、下部が厚壁９５に構成される一方で、厚壁９５の上部が２段の段差に構成されている。具体的には、厚壁９５の上端において矢印Ｂ１側が最も低く形成され、その内側（幅方向中央部から矢印Ｂ２側）に短く突出した突壁９７を有し、さらに突壁９７の上端且つ矢印Ｂ２側において短く突出したレール壁９８を有する。矢印Ｂ１側におけるレール壁９８の高さは、矢印Ｂ２側におけるレール壁９６の高さと同一である。厚壁９５と突壁９７とで構成される段差部分には、組立状態で上グリップ７０の上部側壁７２が配置される。 The lower side wall 92 on the arrow B1 side has a thick wall 95 at the lower part, while the upper part of the thick wall 95 has a two-step step. Specifically, the arrow B1 side is formed at the lowest position at the upper end of the thick wall 95, and has a protruding wall 97 that projects shortly inside (from the central portion in the width direction to the arrow B2 side), and further, the upper end of the protruding wall 97 and the arrow. It has a rail wall 98 that projects short on the B2 side. The height of the rail wall 98 on the arrow B1 side is the same as the height of the rail wall 96 on the arrow B2 side. The upper side wall 72 of the upper grip 70 is arranged in the stepped portion composed of the thick wall 95 and the protruding wall 97 in the assembled state.
　突壁９７とレール壁９８とで構成される段差部分は、組立状態でカバー体４１の被係止凸部４８が配置される。すなわち、上グリップ７０の上部側壁７２とレール壁９８との間には、被係止凸部４８が摺動可能な被係止凸部用ガイド空間９９ａ（セーフティガイド空間９９の一部）が形成される。 In the stepped portion composed of the protruding wall 97 and the rail wall 98, the locked convex portion 48 of the cover body 41 is arranged in the assembled state. That is, a guide space 99a (a part of the safety guide space 99) for the locked convex portion on which the locked convex portion 48 can slide is formed between the upper side wall 72 of the upper grip 70 and the rail wall 98. Will be done.
　セーフティ部材４０をガイドするガイド機構４６は、上グリップ７０の一対の上部側壁７２と一対の突条部７４、下グリップ９０の一対のレール壁９６、９８により構成される。つまり、上グリップ７０と下グリップ９０の組立状態で、一対の突条部７４とレール壁９６、９８の上下間には、セーフティ部材４０の突出部４４をガイドするセーフティガイド空間９９が形成される。セーフティ部材４０は、ガイド機構４６の構築状態で、被ガイド突部４７と被係止凸部４８の間の隙間に下グリップ９０の矢印Ｂ１側のレール壁９８を配置させる。また上記したように、一対のレール壁９６、９８上には、カテーテル操作部材６０の操作板部６１の側縁６１ａが配置されてカテーテル操作部材６０の進退もガイド可能となっている（図１２中では、操作板部６１を２点鎖線で示している）。換言すれば本実施形態において、セーフティガイド空間９９は操作部材ガイド空間１００を共有している。 The guide mechanism 46 that guides the safety member 40 is composed of a pair of upper side walls 72 of the upper grip 70, a pair of ridges 74, and a pair of rail walls 96 and 98 of the lower grip 90. That is, in the assembled state of the upper grip 70 and the lower grip 90, a safety guide space 99 for guiding the protruding portion 44 of the safety member 40 is formed between the pair of ridge portions 74 and the upper and lower rail walls 96 and 98. .. The safety member 40 arranges the rail wall 98 on the arrow B1 side of the lower grip 90 in the gap between the guided protrusion 47 and the locked convex portion 48 in the state where the guide mechanism 46 is constructed. Further, as described above, the side edge 61a of the operation plate portion 61 of the catheter operating member 60 is arranged on the pair of rail walls 96 and 98 so that the advancement and retreat of the catheter operating member 60 can be guided (FIG. 12). Inside, the operation plate portion 61 is indicated by a two-dot chain line). In other words, in the present embodiment, the safety guide space 99 shares the operating member guide space 100.
　セーフティガイド空間９９は、下グリップ９０に対して上グリップ７０が離間している状態で上方が開放され、下グリップ９０に上グリップ７０を固定した状態で閉塞される。その一方で、カテーテル操作部材６０の一対の側縁６１ａは、セーフティ部材４０の一対の突出部４４の幅よりも狭い幅に形成され、一対のレール壁９６、９８上に配置される。このため操作部材ガイド空間１００は、後記の下支え部材１２０によりセーフティガイド空間９９よりも幅狭に設定され、グリップ１８の先端（先端開放部１８ｂ）において開放しており、カテーテル操作部材６０を送出可能としている。 The safety guide space 99 is opened upward with the upper grip 70 separated from the lower grip 90, and is closed with the upper grip 70 fixed to the lower grip 90. On the other hand, the pair of side edges 61a of the catheter operating member 60 are formed to have a width narrower than the width of the pair of protrusions 44 of the safety member 40, and are arranged on the pair of rail walls 96 and 98. Therefore, the operating member guide space 100 is set narrower than the safety guide space 99 by the supporting member 120 described later, and is opened at the tip (tip opening portion 18b) of the grip 18, so that the catheter operating member 60 can be delivered. It is supposed to be.
　図１３Ａ及び図１３Ｂに示すように、下グリップ９０の先端には、一対の下部側壁９２から幅方向外側に突出する一対の突体１０１が設けられている。一対の突体１０１は、矢印Ｃ方向に沿って充分な厚みを有しており、その上面はレール壁９６、９８の上端よりも若干高い位置にある。一対の突体１０１は、上グリップ７０と下グリップ９０との固定を行う固定機構７９、及び下支え部材１２０を配置する配置機構１０２を構成する。 As shown in FIGS. 13A and 13B, a pair of projecting bodies 101 projecting outward in the width direction from the pair of lower side walls 92 are provided at the tip of the lower grip 90. The pair of projectiles 101 have a sufficient thickness along the direction of arrow C, and the upper surface thereof is located slightly higher than the upper ends of the rail walls 96 and 98. The pair of projectiles 101 constitutes a fixing mechanism 79 for fixing the upper grip 70 and the lower grip 90, and an arrangement mechanism 102 for arranging the lower support member 120.
　矢印Ｂ１側の突体１０１（以下、第１突体１０３という）は、下部側壁９２の上部から矢印Ｂ１側に突出している。第１突体１０３には、固定機構７９の一部である第１固定孔１０３ａが厚さ方向に貫通形成されている。第１固定孔１０３ａには、組立時に、第１上突片部７８ａの先端固定用フック８０が挿入されることで、爪が突体１０１の下端面に引っ掛かる。また、第１突体１０３の矢印Ｂ１側には、上方向に短く突出する位置決め突起１０４が設けられ、この位置決め突起１０４は第１上突片部７８ａの位置決め切り欠き８２に挿入される。 The projectile 101 on the arrow B1 side (hereinafter referred to as the first projectile 103) projects from the upper part of the lower side wall 92 toward the arrow B1. A first fixing hole 103a, which is a part of the fixing mechanism 79, is formed through the first projecting body 103 in the thickness direction. At the time of assembly, the tip fixing hook 80 of the first upper projecting piece portion 78a is inserted into the first fixing hole 103a, so that the claw is caught on the lower end surface of the projecting body 101. Further, a positioning projection 104 that projects shortly upward is provided on the arrow B1 side of the first projecting body 103, and the positioning projection 104 is inserted into the positioning notch 82 of the first upper projecting piece portion 78a.
　矢印Ｂ２側の突体１０１は、下部側壁９２の上下において矢印Ｂ２側に突出し（以下、矢印Ｃ１側を第２突体上ブロック１０５といい、矢印Ｃ２側を第２突体下ブロック１０６という）、その間に下支え部材１２０が回転移動可能な移動用空間１０７を有する。第２突体上ブロック１０５の先端側には、下支え部材１２０を回転可能に支持する軸受切り欠き１０５ａが設けられている。軸受切り欠き１０５ａは、平面視で、矢印Ｂ１側に開放したＵ字状に形成され、内側の収容空間１８ａに連通している。軸受切り欠き１０５ａの上端部は、下側部分よりも大径の段差状に形成されており、後記の下支え部材１２０の一対の小突起１２３がこの段差部分に配置される。また、第２突体上ブロック１０５の基端側には、固定機構７９の一部である第２固定孔１０５ｂが厚さ方向に貫通形成され、さらに矢印Ｂ２側には、第２上突片部７８ｂの位置決め切り欠き８２に挿入される位置決め突起１０４が設けられている。 The projectile 101 on the arrow B2 side projects toward the arrow B2 above and below the lower side wall 92 (hereinafter, the arrow C1 side is referred to as the second projectile upper block 105, and the arrow C2 side is referred to as the second projectile lower block 106). In the meantime, the support member 120 has a moving space 107 in which the support member 120 can rotate and move. A bearing notch 105a that rotatably supports the lower support member 120 is provided on the tip end side of the second projectile upper block 105. The bearing notch 105a is formed in a U shape open to the arrow B1 side in a plan view, and communicates with the inner accommodation space 18a. The upper end portion of the bearing notch 105a is formed in a stepped shape having a diameter larger than that of the lower portion, and a pair of small protrusions 123 of the support member 120 described later are arranged in this stepped portion. Further, a second fixing hole 105b, which is a part of the fixing mechanism 79, is formed through the base end side of the second projecting body upper block 105 in the thickness direction, and a second upper projecting piece is further formed on the arrow B2 side. A positioning protrusion 104 to be inserted into the positioning notch 82 of the portion 78b is provided.
　第２突体下ブロック１０６は、下支え部材１２０の配置機構１０２を構成するために、第２突体上ブロック１０５の先端側に対向する範囲に設けられる。第２突体下ブロック１０６の上面には、下支え部材１２０を軸支する下軸受穴１０８が設けられている。 The second projectile lower block 106 is provided in a range facing the tip end side of the second projectile upper block 105 in order to form the arrangement mechanism 102 of the support member 120. A lower bearing hole 108 that pivotally supports the lower support member 120 is provided on the upper surface of the second projecting lower block 106.
　下支え部材１２０は、グリップ１８の配置機構１０２により回転自在に取り付けられ、穿刺前状態において、カテーテル操作部材６０の下側を延在するカテーテル１２（多重管１１）を下支えする部品である。また、下支え部材１２０は、カテーテル操作部材６０の移動においてハブ収容部６２の壁が接触することで回転し、収容空間１８ａからカテーテル操作部材６０を送出可能とする。 The support member 120 is a component that is rotatably attached by the arrangement mechanism 102 of the grip 18 and supports the catheter 12 (multi-tube 11) extending below the catheter operating member 60 in the pre-puncture state. Further, the support member 120 rotates when the wall of the hub accommodating portion 62 comes into contact with the movement of the catheter operating member 60, so that the catheter operating member 60 can be sent out from the accommodating space 18a.
　この下支え部材１２０は、矢印Ｃ方向に延在する軸部１２１と、軸部１２１の軸心と直交方向に突出する支持本体部１２２とを有する。軸部１２１の上部には、レール壁９６の上端に連なるガイド平面１２１ａ及びガイド平面１２１ａを有する一対の小突起１２３が設けられている。ガイド平面１２１ａには、穿刺前状態で、カテーテル操作部材６０の側縁６１ａが近接し、下支え部材１２０の回転を規制する。 The support member 120 has a shaft portion 121 extending in the direction of arrow C and a support main body portion 122 projecting in a direction orthogonal to the axis of the shaft portion 121. A pair of small protrusions 123 having a guide plane 121a and a guide plane 121a connected to the upper end of the rail wall 96 are provided on the upper portion of the shaft portion 121. The side edge 61a of the catheter operating member 60 is close to the guide plane 121a in the state before puncture, and restricts the rotation of the support member 120.
　支持本体部１２２は、平面視で、軸部１２１の連結部分近傍が幅狭で、連結部分近傍から離れるに従って幅広となっている。支持本体部１２２の上面は、軸部１２１から突出方向に向かって平坦状（底壁９１に平行）に構成され、また突出端において下方向に傾斜している。突出端の基端側には上面に沿った傾斜突部１２２ａが突出形成されている。 The support main body portion 122 is narrow in the vicinity of the connecting portion of the shaft portion 121 in a plan view, and becomes wider as the distance from the vicinity of the connecting portion is increased. The upper surface of the support main body 122 is formed to be flat (parallel to the bottom wall 91) in the protruding direction from the shaft 121, and is inclined downward at the protruding end. An inclined protrusion 122a along the upper surface is formed on the base end side of the protruding end.
　このように構成された下支え部材１２０は、支持本体部１２２を矢印Ｂ１側に向けた姿勢で下グリップ９０の上から軸受切り欠き１０５ａに沿って挿入される。この際、支持本体部１２２の連結部分近傍が軸受切り欠き１０５ａの収容空間１８ａ側の開放部分を通過することで、下支え部材１２０は、軸受切り欠き１０５ａ及び下軸受穴１０８にスムーズに挿入される。上グリップ７０と下グリップ９０を装着した際に、下グリップ９０に支持された軸部１２１の上端が上グリップ７０の上軸受穴８３に配置される。 The lower support member 120 configured in this way is inserted along the bearing notch 105a from above the lower grip 90 in a posture in which the support main body portion 122 is directed toward the arrow B1 side. At this time, the lower support member 120 is smoothly inserted into the bearing notch 105a and the lower bearing hole 108 by passing the vicinity of the connecting portion of the support main body portion 122 through the open portion of the bearing notch 105a on the accommodation space 18a side. .. When the upper grip 70 and the lower grip 90 are attached, the upper end of the shaft portion 121 supported by the lower grip 90 is arranged in the upper bearing hole 83 of the upper grip 70.
　そして穿刺前状態では、カテーテル操作部材６０の側縁６１ａがガイド平面１２１ａに存在することで、支持本体部１２２の回転が規制されてカテーテル１２を支持可能に待機する。これにより、支持本体部１２２は、カテーテル１２を下支えして、カテーテル１２の撓みを抑制する。カテーテル操作部材６０がグリップ１８から抜け出す際に、下支え部材１２０は、ガイド平面１２１ａから側縁６１ａが抜けることで回転可能となり、カテーテル操作部材６０及びセーフティ部材４０の送出を許容する。 Then, in the pre-puncture state, the side edge 61a of the catheter operating member 60 is present on the guide plane 121a, so that the rotation of the support main body 122 is restricted and the catheter 12 is supported and waits. As a result, the support main body 122 supports the catheter 12 and suppresses the deflection of the catheter 12. When the catheter operating member 60 comes out of the grip 18, the support member 120 becomes rotatable by the side edge 61a coming out of the guide plane 121a, and allows the catheter operating member 60 and the safety member 40 to be delivered.
　また図１４に示すように、下グリップ９０の矢印Ｂ１側の下部側壁９２には、セーフティ部材４０（カバー体４１）の移動を制限するセーフティ移動制限機構部４９の他方である係止部１０９が設けられている。係止部１０９は、下部側壁９２を上側から切り欠いた空間部１１０と、被係止凸部４８の進出方向に対向する進出制限部１１１と、被係止凸部４８の後退を規制する後退制限部１１２とを有する。空間部１１０は、セーフティガイド空間９９の先端に連通している。 Further, as shown in FIG. 14, on the lower side wall 92 on the arrow B1 side of the lower grip 90, a locking portion 109, which is the other side of the safety movement limiting mechanism portion 49 that restricts the movement of the safety member 40 (cover body 41), is provided. It is provided. The locking portion 109 is a space portion 110 in which the lower side wall 92 is cut out from above, an advance limiting portion 111 facing the locked convex portion 48 in the advancing direction, and a retracting portion that regulates the retreat of the locked convex portion 48. It has a limiting unit 112. The space portion 110 communicates with the tip of the safety guide space 99.
　進出制限部１１１は、空間部１１０の上側（矢印Ｃ１側）から矢印Ａ２側に向かって突出し、幅方向外側に形成された第１突体１０３と連なっている。そして、進出制限部１１１の矢印Ａ２側の突出端が被係止凸部４８の進出を制限する進出制限面１１１ａに形成されている。進出制限面１１１ａは、矢印Ｃ方向に沿って平坦状に構成されている。 The advance restriction portion 111 projects from the upper side (arrow C1 side) of the space portion 110 toward the arrow A2 side, and is connected to the first projectile 103 formed on the outer side in the width direction. The protruding end of the advance limiting portion 111 on the arrow A2 side is formed on the advance limiting surface 111a that restricts the advance of the locked convex portion 48. The advance restriction surface 111a is formed flat along the direction of arrow C.
　後退制限部１１２は、空間部１１０内を矢印Ａ２側に延在する弾性アーム部１１３と、弾性アーム部１１３の突出端から矢印Ｃ１側且つ矢印Ａ１側に傾斜して折り返した返し部１１４とを有する。弾性アーム部１１３は、矢印Ｃ方向に弾性変形可能であり、進出中の被係止凸部４８が返し部１１４に接触した際に弾性変形し、被係止凸部４８が矢印Ａ１側に移動すると弾性復元する。 The retreat limiting portion 112 includes an elastic arm portion 113 extending in the space portion 110 toward the arrow A2 side, and a return portion 114 that is inclined and folded back toward the arrow C1 side and the arrow A1 side from the protruding end of the elastic arm portion 113. Have. The elastic arm portion 113 can be elastically deformed in the direction of arrow C, and when the locked convex portion 48 that is advancing comes into contact with the return portion 114, the elastic arm portion 113 is elastically deformed, and the locked convex portion 48 moves to the arrow A1 side. Then, it is elastically restored.
　返し部１１４は、レール壁９８の上端と同じ高さ位置まで突出している。返し部１１４は、矢印Ｃ１側に向かって矢印Ａ１側に傾斜した後退制限面１１４ａを、返しの内側（進出制限面１１１ａの対向側）に有する。係止部１０９は、進出制限面１１１ａと後退制限面１１４ａとの間を被係止凸部４８の進出位置としている。 The return portion 114 protrudes to the same height position as the upper end of the rail wall 98. The return portion 114 has a receding limiting surface 114a inclined toward the arrow A1 side toward the arrow C1 side on the inside of the return (opposite side of the advancing limiting surface 111a). The locking portion 109 has an advancing position of the locked convex portion 48 between the advancing limiting surface 111a and the retreating limiting surface 114a.
　また、返し部１１４の外側の上端部は、矢印Ｃ１側に向かって矢印Ａ１側に傾斜することで被係止凸部４８の乗り越えを容易化する案内面１１４ｂとなっている。さらに、返し部１１４は、後退制限面１１４ａの矢印Ｂ２側から矢印Ａ１側に突出する薄壁１１４ｃが設けられている。薄壁１１４ｃは、その幅方向位置が矢印Ｂ１側のレール壁９８と同じ位置にあり、その内側面によってカバー体４１の被ガイド突部４７をガイドし、また被係止凸部４８の矢印Ｂ２側へのズレを防止する。 Further, the outer upper end portion of the return portion 114 is a guide surface 114b that facilitates overcoming of the locked convex portion 48 by inclining toward the arrow A1 side toward the arrow C1 side. Further, the return portion 114 is provided with a thin wall 114c protruding from the arrow B2 side of the retreat limiting surface 114a to the arrow A1 side. The thin wall 114c is located at the same position as the rail wall 98 on the arrow B1 side in the width direction, and the inner side surface of the thin wall 114c guides the guided protrusion 47 of the cover body 41, and the arrow B2 of the locked convex portion 48. Prevents deviation to the side.
　ここで、セーフティ部材４０の被係止凸部４８は、突出部４４から矢印Ｂ１側に短く突出すると共に、先端面４８ａ、上面４８ｂ、下面４８ｃ及び基端面４８ｄを有する立体形状に形成されている。先端面４８ａは、矢印Ｃ方向に対し平行に形成されており、上面４８ｂは矢印Ａ方向に対し平行に形成されている。一方、下面４８ｃは、先端面４８ａの下端から矢印Ａ２側に向かって矢印Ｃ２側に傾斜しており、被係止凸部４８が返し部１１４を乗り越える際に、返し部１１４の案内面１１４ｂに案内される面となっている。基端面４８ｄは、上面４８ｂから矢印Ｃ２側に向かって矢印Ａ２側に傾斜しており、進出位置に被係止凸部４８が移動した際に、後退制限面１１４ａと同じ傾斜方向になって対向する。これにより、セーフティ部材４０に後退の力がかかった際に、被係止凸部４８の基端面４８ｄと後退制限面１１４ａが積極的に引っ掛かり合い、セーフティ部材４０の後退を規制する。 Here, the locked convex portion 48 of the safety member 40 projects shortly from the protruding portion 44 toward the arrow B1 side, and is formed in a three-dimensional shape having a tip surface 48a, an upper surface 48b, a lower surface 48c, and a base end surface 48d. .. The front end surface 48a is formed parallel to the arrow C direction, and the upper surface 48b is formed parallel to the arrow A direction. On the other hand, the lower surface 48c is inclined toward the arrow C2 side from the lower end of the tip surface 48a toward the arrow A2 side, and when the locked convex portion 48 gets over the return portion 114, it becomes a guide surface 114b of the return portion 114. It is a guided surface. The base end surface 48d is inclined from the upper surface 48b toward the arrow C2 side toward the arrow A2 side, and when the locked convex portion 48 moves to the advance position, the base end surface 48d faces the same inclination direction as the retreat limiting surface 114a. To do. As a result, when a retreating force is applied to the safety member 40, the base end surface 48d of the locked convex portion 48 and the retreat limiting surface 114a are positively engaged with each other to regulate the retreat of the safety member 40.
　図１０に戻り、下グリップ９０の下部後壁９３は、レール壁９６、９８よりも矢印Ｃ１側に突出すると共に、矢印Ａ２側に突出する基端フランジ１１５を有する。基端フランジ１１５には、厚さ方向に沿って第３固定孔１１５ａが貫通形成されている。第３固定孔１１５ａは、矢印Ｂ方向に長く形成され、基端固定用フック８４及び固定用突起８５をまとめて挿入可能としている。 Returning to FIG. 10, the lower rear wall 93 of the lower grip 90 has a proximal flange 115 projecting toward the arrow C1 side and projecting toward the arrow A2 side with respect to the rail walls 96 and 98. A third fixing hole 115a is formed through the base end flange 115 along the thickness direction. The third fixing hole 115a is formed long in the direction of arrow B so that the base end fixing hook 84 and the fixing protrusion 85 can be inserted together.
　本実施形態に係るカテーテル組立体１０は、基本的には以上のように構成されるものであり、以下このカテーテル組立体１０の組立について説明する。 The catheter assembly 10 according to the present embodiment is basically configured as described above, and the assembly of the catheter assembly 10 will be described below.
　カテーテル組立体１０は、図１５に示す手順に沿って各部材を組み立てていく。概略的には、内外針組立体１６を先に組み立てた後に、この内外針組立体１６を下グリップ９０に配置し、さらに上グリップ７０を内外針組立体１６及び下グリップ９０に装着する。 The catheter assembly 10 assembles each member according to the procedure shown in FIG. Generally, after assembling the inner / outer needle assembly 16 first, the inner / outer needle assembly 16 is arranged on the lower grip 90, and the upper grip 70 is further attached to the inner / outer needle assembly 16 and the lower grip 90.
　内外針組立体１６の組立では、まずセーフティ部材４０を内針１４に組み込む工程を行う（ステップＳ１）。この場合、図１６に示すように、内針１４と内針ハブ３０を予め固定した部品、鈍針５０と鈍針ハブ５１を予め固定した部品、及びカバー体４１を用意する。そして、内針ハブ３０の基端から鈍針５０の先端を挿入していき、内針１４の中空部１４ａに沿って鈍針５０を進出させていく。鈍針ハブ５１のアーム部５３は、内針ハブ３０の保持枠部３２内の空間を通して保持枠部３２の先端側に導かれ、また鈍針ハブ５１の鈍針保持部５２は、保持枠部３２内の筒状部３５の基端に対向する位置に配置される。 In assembling the inner / outer needle assembly 16, first, a step of incorporating the safety member 40 into the inner needle 14 is performed (step S1). In this case, as shown in FIG. 16, a part in which the inner needle 14 and the inner needle hub 30 are fixed in advance, a part in which the blunt needle 50 and the blunt needle hub 51 are fixed in advance, and a cover body 41 are prepared. Then, the tip of the blunt needle 50 is inserted from the base end of the inner needle hub 30, and the blunt needle 50 is advanced along the hollow portion 14a of the inner needle 14. The arm portion 53 of the blunt needle hub 51 is guided to the tip end side of the holding frame portion 32 through the space inside the holding frame portion 32 of the inner needle hub 30, and the blunt needle holding portion 52 of the blunt needle hub 51 is the holding frame portion. It is arranged at a position facing the base end of the tubular portion 35 in 32.
　そして、カバー体４１の先端カバー部４２（保護空間４２ａ）の基端から、内針１４の先端を挿入していく。先端カバー部４２は、基端側が太い筒状で保護空間４２ａも広くなっているので、内針１４の針先１５を容易に進入可能とする。内針１４に沿ってカバー体４１を基端方向に移動し、カバー体４１の係合用突部４５が内針ハブ３０内を通過した鈍針ハブ５１のアーム部５３の先端に至ると、係合用突部４５と係合部５４を係合させてセーフティ部材４０として一体化させる。すなわち、この段階ではセーフティ部材４０の先端から内針１４が露出してセーフティ保有組立体１３０となる。 Then, the tip of the inner needle 14 is inserted from the base end of the tip cover portion 42 (protection space 42a) of the cover body 41. Since the tip cover portion 42 has a thick tubular shape on the base end side and a wide protective space 42a, the needle tip 15 of the inner needle 14 can be easily entered. When the cover body 41 is moved toward the proximal end along the inner needle 14, and the engaging protrusion 45 of the cover body 41 reaches the tip of the arm portion 53 of the blunt needle hub 51 that has passed through the inner needle hub 30, the engagement is engaged. The combined protrusion 45 and the engaging portion 54 are engaged and integrated as a safety member 40. That is, at this stage, the inner needle 14 is exposed from the tip of the safety member 40 to form the safety holding assembly 130.
　次に、カテーテル１２とカテーテルハブ２０（弁部材２２を含む）を予め固定した部品（留置体）を、上記の内針１４及びセーフティ部材４０からなるセーフティ保有組立体１３０に組み込む工程を行う（ステップＳ２）。図１７に示すように、カテーテルハブ２０に弁部材２２を挿入した状態で、弁部材２２の弁孔２５に対し基端側から内針１４の先端を挿入していく。この際、弁部材２２は、カバー体４１の先端カバー部４２がまだ挿入されていないので弁孔２５が開放し易くなっている。従って、弁部材２２は、内針１４の突き刺さりが抑止されつつ、内針１４の外周面上を円滑に移動する。 Next, a step of incorporating a component (indwelling body) to which the catheter 12 and the catheter hub 20 (including the valve member 22) are fixed in advance into the safety holding assembly 130 including the inner needle 14 and the safety member 40 is performed (step). S2). As shown in FIG. 17, with the valve member 22 inserted in the catheter hub 20, the tip of the inner needle 14 is inserted into the valve hole 25 of the valve member 22 from the proximal end side. At this time, since the tip cover portion 42 of the cover body 41 has not yet been inserted into the valve member 22, the valve hole 25 is easily opened. Therefore, the valve member 22 smoothly moves on the outer peripheral surface of the inner needle 14 while suppressing the sticking of the inner needle 14.
　そして、カテーテルハブ２０の軸方向（基端方向）への移動を継続することで、カテーテルハブ２０を先端カバー部４２の外周面に一旦装着する。この状態では、弁部材２２を介してカテーテルハブ２０と先端カバー部４２が嵌合する。そして、カテーテルハブ２０よりも先端では、カテーテル１２の先端から内針１４の針先１５が突出した多重管１１が形成される。 Then, by continuing the movement of the catheter hub 20 in the axial direction (base end direction), the catheter hub 20 is temporarily attached to the outer peripheral surface of the tip cover portion 42. In this state, the catheter hub 20 and the tip cover portion 42 are fitted via the valve member 22. Then, at the tip of the catheter hub 20, a multi-tube 11 is formed in which the needle tip 15 of the inner needle 14 protrudes from the tip of the catheter 12.
　上記の多重管１１の形成状態で、図１５に示すように、カテーテル１２及び内針１４をコーティング材１３に浸ける（ディップする）工程を行う（ステップＳ３）。このディッピングでは、コーティング材１３を図示しない貯留槽に貯留しておき、セーフティ保有組立体１３０を基端に有する状態の多重管１１の先端を下方に向けて、貯留液の上方から下方に進入させる。そして、カテーテルハブ２０が浸からない位置で一定時間待機し、その後に多重管１１を上方に引き上げる。これにより、カテーテル１２の表面及び針先１５にコーティング材１３が塗布される。またディッピング時は、カテーテル操作部材６０が装着されていない状態なので、カテーテル操作部材６０にコーティング材１３が塗布されることがない。 In the formed state of the multiple tube 11, as shown in FIG. 15, a step of immersing (dip) the catheter 12 and the inner needle 14 in the coating material 13 is performed (step S3). In this dipping, the coating material 13 is stored in a storage tank (not shown), and the tip of the multi-layer pipe 11 having the safety holding assembly 130 at the base end is directed downward to enter the stored liquid from above to below. .. Then, the catheter hub 20 waits for a certain period of time at a position where it is not immersed, and then the multilayer tube 11 is pulled upward. As a result, the coating material 13 is applied to the surface of the catheter 12 and the needle tip 15. Further, at the time of dipping, since the catheter operating member 60 is not attached, the coating material 13 is not applied to the catheter operating member 60.
　コーティング材１３の形成後に、カテーテル操作部材６０を組み込む工程を行う（ステップＳ４）。この工程では、ディッピングのために嵌合していたカテーテルハブ２０とセーフティ部材４０を分離させる。すなわち図１７に示すように、カテーテルハブ２０をセーフティ部材４０（セーフティ保有組立体１３０）に対して軸方向（先端方向）に相対移動させる。これによりカテーテルハブ２０の弁部材２２よりも基端で、先端カバー部４２よりも先端に内針１４が露出する。 After forming the coating material 13, a step of incorporating the catheter operating member 60 is performed (step S4). In this step, the catheter hub 20 and the safety member 40 that have been fitted for dipping are separated. That is, as shown in FIG. 17, the catheter hub 20 is relatively moved in the axial direction (tip direction) with respect to the safety member 40 (safety holding assembly 130). As a result, the inner needle 14 is exposed at the base end of the catheter hub 20 with respect to the valve member 22 and at the tip end with respect to the tip end cover portion 42.
　この弁部材２２の基端とセーフティ部材４０の先端との間に内針１４が露出している状態で、カテーテル操作部材６０を側方から装着する。ここで、カテーテル操作部材６０の操作部筒部６３に形成されたスリット６３ｂの幅Ｗは、内針１４の外径φよりも大きいため、スリット６３ｂを介して操作部筒部６３の挿通空間６３ａに内針１４をスムーズに入れることができる。またカテーテル操作部材６０のハブ収容部６２は下方が開放されていることで、内針１４が挿通されたままカテーテルハブ２０（弁部材２２を含む）を収容室６２ａに簡単に入れることができる。 The catheter operating member 60 is mounted from the side with the inner needle 14 exposed between the base end of the valve member 22 and the tip of the safety member 40. Here, since the width W of the slit 63b formed in the operating portion tubular portion 63 of the catheter operating member 60 is larger than the outer diameter φ of the inner needle 14, the insertion space 63a of the operating portion tubular portion 63 is passed through the slit 63b. The inner needle 14 can be smoothly inserted into the slit. Further, since the hub accommodating portion 62 of the catheter operating member 60 is open at the lower side, the catheter hub 20 (including the valve member 22) can be easily inserted into the accommodating chamber 62a with the inner needle 14 inserted.
　そして、カテーテル操作部材６０にカテーテルハブ２０（弁部材２２を含む）が収容された状態で、カテーテルハブ２０及びカテーテル操作部材６０を基端方向に移動させる。これにより、セーフティ部材４０の先端が弁部材２２の弁孔２５に再挿入される。そして、カテーテル操作部材６０の操作部筒部６３の基端がセーフティ部材４０の先端カバー部４２と基端延在部４３の連結部４３ａの先端に達した段階では、セーフティ部材４０が弁部材２２に強く嵌合した状態となる。これにより、カテーテル１２、カテーテルハブ２０、内針１４、内針ハブ３０、セーフティ部材４０、カテーテル操作部材６０が組み立てられた内外針組立体１６が構築される。 Then, with the catheter hub 20 (including the valve member 22) housed in the catheter operating member 60, the catheter hub 20 and the catheter operating member 60 are moved toward the proximal end. As a result, the tip of the safety member 40 is reinserted into the valve hole 25 of the valve member 22. Then, when the base end of the operation portion tubular portion 63 of the catheter operating member 60 reaches the tip of the connecting portion 43a of the tip cover portion 42 of the safety member 40 and the proximal end extending portion 43, the safety member 40 reaches the valve member 22. It will be in a state of being tightly fitted to. As a result, the inner / outer needle assembly 16 in which the catheter 12, the catheter hub 20, the inner needle 14, the inner needle hub 30, the safety member 40, and the catheter operating member 60 are assembled is constructed.
　その後、組立では、先に組み立てた内外針組立体１６を下グリップ９０に配置する工程を行う（ステップＳ５）。この際、下グリップ９０は、上記した組立方法（図１３Ａ及び図１３Ｂ参照）により下支え部材１２０を装着した状態としておく。図１８に示すように組立では、この下グリップ９０の上方の開放部分から下側（矢印Ｃ２側）に向かって内外針組立体１６を挿入し、内針ハブ３０の複数の固定用凸部３４を下グリップ９０の複数の装着孔９４にそれぞれ挿入及び嵌合させる（図１１も参照）。これにより内外針組立体１６が下グリップ９０に係合する。 After that, in the assembly, the step of arranging the previously assembled inner / outer needle assembly 16 on the lower grip 90 is performed (step S5). At this time, the lower grip 90 is in a state where the support member 120 is attached by the above-mentioned assembly method (see FIGS. 13A and 13B). As shown in FIG. 18, in the assembly, the inner / outer needle assembly 16 is inserted from the upper open portion of the lower grip 90 toward the lower side (arrow C2 side), and the plurality of fixing convex portions 34 of the inner needle hub 30 are inserted. Is inserted and fitted into the plurality of mounting holes 94 of the lower grip 90, respectively (see also FIG. 11). As a result, the inner / outer needle assembly 16 engages with the lower grip 90.
　ここで、上グリップ７０と下グリップ９０との間に形成されるセーフティガイド空間９９（空間部１１０）、操作部材ガイド空間１００は、下グリップ９０から上グリップ７０が離間した状態で開放している。このため、下グリップ９０に対する内外針組立体１６の矢印Ｃ２側に向かう挿入により、セーフティ部材４０及びカテーテル操作部材６０を容易に配置することができる。 Here, the safety guide space 99 (space 110) and the operating member guide space 100 formed between the upper grip 70 and the lower grip 90 are opened in a state where the upper grip 70 is separated from the lower grip 90. .. Therefore, the safety member 40 and the catheter operating member 60 can be easily arranged by inserting the inner / outer needle assembly 16 into the lower grip 90 toward the arrow C2 side.
　最後に、組立では、内外針組立体１６が係合した下グリップ９０に対して上グリップ７０を装着する工程を行う（ステップＳ６）。つまり下グリップ９０の上方から下側（矢印Ｃ２側）に向かって上グリップ７０を近づけて、上グリップ７０の第１及び第２上突片部７８ａ、７８ｂの先端固定用フック８０を下グリップ９０の第１及び第２固定孔１０３ａ、１０５ｂに挿入し第１突体１０３及び第２突体上ブロック１０５に引っ掛ける。また上グリップ７０の基端固定用フック８４及び固定用突起８５を下グリップ９０の第３固定孔１１５ａに挿入し、基端固定用フック８４を基端フランジ１１５に引っ掛ける。このように上グリップ７０及び下グリップ９０は、先端においてカテーテル操作部材６０を間に挟んだ２箇所と、基端の１箇所とを相互に固定することで、グリップ１８として強固に一体化した状態となる。 Finally, in the assembly, a step of attaching the upper grip 70 to the lower grip 90 with which the inner / outer needle assembly 16 is engaged is performed (step S6). That is, the upper grip 70 is brought closer from the upper side of the lower grip 90 toward the lower side (arrow C2 side), and the tip fixing hooks 80 of the first and second upper projecting pieces 78a and 78b of the upper grip 70 are attached to the lower grip 90. It is inserted into the first and second fixing holes 103a and 105b of the above, and hooked on the first projecting body 103 and the second projecting body upper block 105. Further, the base end fixing hook 84 and the fixing protrusion 85 of the upper grip 70 are inserted into the third fixing hole 115a of the lower grip 90, and the base end fixing hook 84 is hooked on the base end flange 115. In this way, the upper grip 70 and the lower grip 90 are firmly integrated as the grip 18 by fixing the two places where the catheter operating member 60 is sandwiched between them at the tip and one place at the base end to each other. It becomes.
　カテーテル組立体１０は、上グリップ７０と下グリップ９０の固定によって組立が終了して穿刺前状態となる。この状態でセーフティ部材４０の一対の突出部４４（被係止凸部４８）が配置されるセーフティガイド空間９９（空間部１１０）は、上グリップ７０及び下グリップ９０の矢印Ａ方向に閉塞されて一対の突出部４４を離脱不能とする。また、内外針組立体１６は、内針ハブ３０がグリップ１８に固定されているため内針１４が移動不能となる一方で、カテーテル１２、カテーテルハブ２０、セーフティ部材４０、カテーテル操作部材６０が内針１４と相対的に進退可能となっている。 The catheter assembly 10 is in the pre-puncture state after the assembly is completed by fixing the upper grip 70 and the lower grip 90. In this state, the safety guide space 99 (space portion 110) in which the pair of protruding portions 44 (locked convex portions 48) of the safety member 40 are arranged is closed in the direction of the arrow A of the upper grip 70 and the lower grip 90. The pair of protrusions 44 are made inseparable. Further, in the inner / outer needle assembly 16, the inner needle hub 30 is fixed to the grip 18, so that the inner needle 14 cannot move, while the catheter 12, the catheter hub 20, the safety member 40, and the catheter operating member 60 are inside. It is possible to move forward and backward relative to the needle 14.
　なお、本発明は、上記の実施形態に限定されず、発明の要旨に沿って種々の改変が可能である。例えば、内針ハブ３０と下グリップ９０を固定する取付機構３３は、上記に限定されず、種々の構成（接着構造、フックによる固定構造等）をとり得る。また、上グリップ７０と下グリップ９０を固定する固定機構７９も、上記に限定されず、種々の構成（接着構造、嵌合構造等）をとり得る。 The present invention is not limited to the above embodiment, and various modifications can be made according to the gist of the invention. For example, the mounting mechanism 33 for fixing the inner needle hub 30 and the lower grip 90 is not limited to the above, and may have various configurations (adhesive structure, fixing structure by hook, etc.). Further, the fixing mechanism 79 for fixing the upper grip 70 and the lower grip 90 is not limited to the above, and may have various configurations (adhesive structure, fitting structure, etc.).
〔変形例〕
　図１９Ａ及び図１９Ｂに示す変形例に係るカテーテル組立体１０Ａは、セーフティ部材４０Ａの移動をガイド及び制限する構造を、カテーテル操作部材６０Ａの操作部分が配置される箇所とは異なる方向に設けた点で、上記のカテーテル組立体１０と異なる。なお、以降の説明において、上記の実施形態と同じ構成又は同じ機能を有する要素には、同じ符号を付してその詳細な説明を省略する。 [Modification example]
The catheter assembly 10A according to the modified example shown in FIGS. 19A and 19B has a structure for guiding and restricting the movement of the safety member 40A in a direction different from the location where the operating portion of the catheter operating member 60A is arranged. Therefore, it is different from the catheter assembly 10 described above. In the following description, elements having the same configuration or the same function as those in the above embodiment are designated by the same reference numerals, and detailed description thereof will be omitted.
　具体的には、カテーテル組立体１０Ａのグリップ１８Ａは、上グリップ１４０と下グリップ１５０に分割可能であるが、上グリップ１４０は、天井壁７１を備えると共に、矢印Ａ２側に後ブロック体１４１を備え、側壁を備えない構成となっている。 Specifically, the grip 18A of the catheter assembly 10A can be divided into an upper grip 140 and a lower grip 150, but the upper grip 140 includes a ceiling wall 71 and a rear block body 141 on the arrow A2 side. , The structure does not have a side wall.
　下グリップ１５０は、底壁９１及び一対の側壁７７を備える一方で、矢印Ａ２側に後壁を備えない構成となっている。また下グリップ１５０は、セーフティ部材４０Ａの被係止凸部４８Ａをガイドするガイド長孔１５１（セーフティガイド空間９９）を底壁９１に備える。ガイド長孔１５１は、下グリップ１５０単体では先端が閉塞されている一方で基端が開放している。このガイド長孔１５１の基端開放部は、下グリップ１５０に上グリップ１４０を装着することに伴い後ブロック体１４１により閉塞される。 The lower grip 150 has a bottom wall 91 and a pair of side walls 77, but does not have a rear wall on the arrow A2 side. Further, the lower grip 150 is provided with a guide elongated hole 151 (safety guide space 99) for guiding the locked convex portion 48A of the safety member 40A in the bottom wall 91. The tip of the long guide hole 151 is closed while the lower grip 150 alone has an open base end. The base end opening portion of the guide elongated hole 151 is closed by the rear block body 141 as the upper grip 140 is attached to the lower grip 150.
　上グリップ１４０と下グリップ１５０の組立状態では、上グリップ１４０の天井壁７１と、下グリップ１５０の各側壁７７との間に、操作部材ガイド空間１００がそれぞれ形成される。一対の操作部材ガイド空間１００には、カテーテル操作部材６０Ａの一対のウイング６８（操作部分）が各々配置される。カテーテル操作部材６０Ａは、カテーテルハブ２０又はセーフティ部材４０Ａに係合され、ユーザにより一対のウイング６８の操作に基づき、カテーテル１２、カテーテルハブ２０及びセーフティ部材４０Ａを進退させることができる。 In the assembled state of the upper grip 140 and the lower grip 150, an operating member guide space 100 is formed between the ceiling wall 71 of the upper grip 140 and each side wall 77 of the lower grip 150. A pair of wings 68 (operating portions) of the catheter operating member 60A are arranged in the pair of operating member guide spaces 100, respectively. The catheter operating member 60A is engaged with the catheter hub 20 or the safety member 40A, and the user can advance and retreat the catheter 12, the catheter hub 20 and the safety member 40A based on the operation of the pair of wings 68.
　カテーテル組立体１０Ａの内外針組立体１６Ａは、カテーテル１２、カテーテルハブ２０、内針１４、内針ハブ３０、セーフティ部材４０Ａ、カテーテル操作部材６０Ａを組み付けて構成される。内針ハブ３０は、内針１４の基端を固定すると共に、取付機構３３を構成する下グリップ１５０の基端側の装着部（不図示）に固定される。セーフティ部材４０Ａは、内針１４が挿通される筒部の基端部に上記の被係止凸部４８Ａを備える。被係止凸部４８Ａは、矢印Ｃ２側に向かって所定長さ突出し、その突出端がガイド長孔１５１よりも幅広に構成されている。従って、被係止凸部４８Ａ（セーフティ部材４０Ａ）は、組立状態で、ガイド長孔１５１からの抜けが防止される。 The inner / outer needle assembly 16A of the catheter assembly 10A is configured by assembling a catheter 12, a catheter hub 20, an inner needle 14, an inner needle hub 30, a safety member 40A, and a catheter operating member 60A. The inner needle hub 30 fixes the base end of the inner needle 14 and is fixed to a mounting portion (not shown) on the base end side of the lower grip 150 constituting the mounting mechanism 33. The safety member 40A includes the above-mentioned locked convex portion 48A at the base end portion of the tubular portion through which the inner needle 14 is inserted. The locked convex portion 48A protrudes toward the arrow C2 side by a predetermined length, and the protruding end thereof is configured to be wider than the guide elongated hole 151. Therefore, the locked convex portion 48A (safety member 40A) is prevented from coming off from the guide elongated hole 151 in the assembled state.
　ガイド長孔１５１は、下グリップ１５０の長手方向（矢印Ａ方向）に沿って延在し、その先端の閉塞部１５２が下グリップ１５０の先端付近に達している。ガイド長孔１５１の閉塞部１５２よりも若干基端側には、被係止凸部４８Ａの進出した進出位置において被係止凸部４８Ａ（セーフティ部材４０Ａ）の移動を制限する係止部１５３（セーフティ移動制限機構部４９の一部）が設けられている。 The long guide hole 151 extends along the longitudinal direction of the lower grip 150 (direction of arrow A), and the closing portion 152 at the tip thereof reaches the vicinity of the tip of the lower grip 150. A locking portion 153 (safety member 40A) that restricts the movement of the locked convex portion 48A (safety member 40A) at the advanced advance position of the locked convex portion 48A slightly closer to the base end side of the guide elongated hole 151 than the closed portion 152 ( A part of the safety movement restriction mechanism unit 49) is provided.
　係止部１５３は、ガイド長孔１５１の先端の閉塞部１５２と、ガイド長孔１５１を幅方向内側に狭める凸状部１５４（返し片部）とによって構成される。凸状部１５４は、被係止凸部４８Ａの矢印Ａ１側の進出時に弾性変形して被係止凸部４８Ａを進出位置に移動させる一方で、進出位置に移動した被係止凸部４８Ａが矢印Ａ２側に後退することを規制する。これにより、セーフティ部材４０Ａは、カテーテルハブ２０と共にグリップ１８Ａから露出され進出位置において内針１４の針先１５を覆った状態で移動が規制されることになり、内針１４の誤刺を良好に防止することができる。 The locking portion 153 is composed of a closing portion 152 at the tip of the guide elongated hole 151 and a convex portion 154 (return piece portion) that narrows the guide elongated hole 151 inward in the width direction. The convex portion 154 is elastically deformed when the locked convex portion 48A is advanced on the arrow A1 side to move the locked convex portion 48A to the advanced position, while the locked convex portion 48A moved to the advanced position is It regulates the retreat to the arrow A2 side. As a result, the safety member 40A is exposed from the grip 18A together with the catheter hub 20 and the movement of the safety member 40A is restricted while covering the needle tip 15 of the inner needle 14 at the advanced position. Can be prevented.
　以上のカテーテル組立体１０Ａは、カテーテル操作部材６０Ａの一対のウイング６８を、上グリップ１４０と下グリップ１５０の境界（操作部材ガイド空間１００）に配置して移動可能とする。よって、カテーテル操作部材６０Ａのグリップ１８Ａからの送出が簡易化する。またセーフティ部材４０Ａのセーフティ移動制限機構部４９が操作部材ガイド空間１００と共有していないことで、グリップ１８Ａの先端部の構成を簡素化させ、進出位置におけるセーフティ部材４０Ａの進退をより強固に制限することが可能となる。 In the above catheter assembly 10A, a pair of wings 68 of the catheter operating member 60A are arranged at the boundary between the upper grip 140 and the lower grip 150 (operation member guide space 100) so that the catheter assembly 10A can be moved. Therefore, the delivery of the catheter operating member 60A from the grip 18A is simplified. Further, since the safety movement limiting mechanism portion 49 of the safety member 40A is not shared with the operating member guide space 100, the configuration of the tip portion of the grip 18A is simplified, and the advance / retreat of the safety member 40A at the advance position is more firmly restricted. It becomes possible to do.
　上記の実施形態から把握し得る技術的思想及び効果について、以下に記載する。 The technical ideas and effects that can be grasped from the above embodiments are described below.
　本発明の一態様は、カテーテル１２と、カテーテル１２を保持するカテーテルハブ２０と、カテーテル１２に挿通された内針１４と、カテーテル１２及びカテーテルハブ２０の移動をユーザが操作するためのカテーテル操作部材６０と、カテーテルハブ２０内に挿入されて嵌合することで当該カテーテルハブ２０と共に移動可能であり、処置対象に穿刺した内針１４の針先１５よりも進出して当該内針１４の誤刺防止機能を発動するセーフティ部材４０とを備えるカテーテル組立体１０であって、カテーテル操作部材６０は、セーフティ部材４０が挿通される挿通空間６３ａを有する筒部（操作部筒部６３）と、筒部の軸方向に延在するスリット６３ｂとを有し、スリット６３ｂは、筒部の側方から挿通空間６３ａに内針１４を通過可能とする一方で、挿通空間６３ａから筒部の側方へのセーフティ部材４０の通過を不能とする。 One aspect of the present invention is a catheter operating member for the user to operate the catheter 12, the catheter hub 20 for holding the catheter 12, the internal needle 14 inserted through the catheter 12, and the catheter 12 and the catheter hub 20. It can be moved together with the catheter hub 20 by being inserted into the catheter hub 20 and fitted with the 60, and it advances beyond the needle tip 15 of the inner needle 14 pierced by the treatment target and erroneously punctures the inner needle 14. A catheter assembly 10 including a safety member 40 that activates a prevention function, wherein the catheter operating member 60 includes a tubular portion (operating unit tubular portion 63) having an insertion space 63a into which the safety member 40 is inserted, and a tubular portion. The slit 63b has a slit 63b extending in the axial direction of the catheter portion, and the slit 63b allows the inner needle 14 to pass through the insertion space 63a from the side of the tubular portion, while the slit 63b from the insertion space 63a to the side of the tubular portion. The passage of the safety member 40 is disabled.
　上記のカテーテル組立体１０は、カテーテルハブ２０内にセーフティ部材４０が挿入及び嵌合する構成であることで、カテーテルハブ２０及びセーフティ部材４０への内針１４の挿通形態で、カテーテルハブ２０とセーフティ部材４０が軸方向に嵌合可能となる。しかも、カテーテル操作部材６０は、筒部（操作部筒部６３）及びスリット６３ｂを有し、このスリット６３ｂが内針１４を通過可能とする一方で、セーフティ部材４０の通過を不能としている。これにより、カテーテルハブ２０に内針１４を挿通してセーフティ部材４０の先端に近づけた状態で、スリット６３ｂを介してカテーテル操作部材６０を内針１４の側方から装着することができる。さらに、セーフティ部材４０に筒部を向かわせて、筒部を挿通したセーフティ部材４０をカテーテルハブ２０内に挿入することが可能となる。従って、カテーテルハブ２０、セーフティ部材４０及びカテーテル操作部材６０同士の組立が簡易化し、作業効率を大幅に向上させることができる。 The catheter assembly 10 has a configuration in which the safety member 40 is inserted and fitted into the catheter hub 20, so that the catheter hub 20 and the safety member 40 can be inserted into the catheter hub 20 and the safety member 40. The member 40 can be fitted in the axial direction. Moreover, the catheter operating member 60 has a tubular portion (operating unit tubular portion 63) and a slit 63b, and while the slit 63b allows the inner needle 14 to pass through, the safety member 40 cannot pass through. As a result, the catheter operating member 60 can be attached from the side of the inner needle 14 via the slit 63b in a state where the inner needle 14 is inserted into the catheter hub 20 and brought close to the tip of the safety member 40. Further, it is possible to insert the safety member 40 through which the tubular portion is inserted into the catheter hub 20 by directing the tubular portion toward the safety member 40. Therefore, the assembly of the catheter hub 20, the safety member 40, and the catheter operating member 60 can be simplified, and the work efficiency can be significantly improved.
　また、スリット６３ｂの幅Ｗは、内針１４の直径（外径φ）よりも大きく、且つセーフティ部材４０の幅（外径Ｄ）よりも小さく形成される。これにより、カテーテル組立体１０は、簡単な構成によって、スリット６３ｂに対して内針１４を通過させることができ、またセーフティ部材４０がスリット６３ｂを通過することを防止してカテーテル操作部材６０とセーフティ部材４０の組立状態を維持することができる。 Further, the width W of the slit 63b is formed to be larger than the diameter (outer diameter φ) of the inner needle 14 and smaller than the width (outer diameter D) of the safety member 40. As a result, the catheter assembly 10 can pass the inner needle 14 through the slit 63b with a simple configuration, and prevents the safety member 40 from passing through the slit 63b to prevent the catheter operating member 60 and the safety member 60 from passing through the slit 63b. The assembled state of the member 40 can be maintained.
　また、カテーテルハブ２０は、弁部材２２が内部に挿入される構成であり、セーフティ部材４０は、弁部材２２の弁孔２５に挿入され当該弁部材２２を介してカテーテルハブ２０内に嵌合される。これにより、カテーテル組立体１０は、弁部材２２を介してカテーテルハブ２０にセーフティ部材４０を適度な嵌合力で保持させることができる。 Further, the catheter hub 20 has a configuration in which the valve member 22 is inserted inside, and the safety member 40 is inserted into the valve hole 25 of the valve member 22 and fitted into the catheter hub 20 via the valve member 22. To. As a result, the catheter assembly 10 can cause the catheter hub 20 to hold the safety member 40 with an appropriate fitting force via the valve member 22.
　また、カテーテル操作部材６０は、カテーテルハブ２０を収容するハブ収容部６２を有し、ユーザの操作によるハブ収容部６２の移動に伴いカテーテルハブ２０及びセーフティ部材４０を追従させる構成であり、さらに、カテーテルハブ２０とセーフティ部材４０の嵌合の解除に基づきカテーテルハブ２０からハブ収容部６２を離脱可能とする。これにより、カテーテル組立体１０は、カテーテルハブ２０とセーフティ部材４０の嵌合の解除時に、カテーテル操作部材６０からカテーテルハブ２０を容易に離脱させることができる。 Further, the catheter operating member 60 has a hub accommodating portion 62 accommodating the catheter hub 20, and is configured to follow the catheter hub 20 and the safety member 40 as the hub accommodating portion 62 moves by the user's operation. The hub accommodating portion 62 can be detached from the catheter hub 20 based on the release of the fitting between the catheter hub 20 and the safety member 40. As a result, the catheter assembly 10 can easily disengage the catheter hub 20 from the catheter operating member 60 when the catheter hub 20 and the safety member 40 are disengaged from each other.
　また、カテーテル１２及び内針１４は、相互に重ねた状態で所定のコーティング材１３に浸けられることで、コーティング材１３が表面に塗布される。これによりカテーテル組立体１０の製造時には、カテーテル１２及び内針１４を重ねた状態でコーティング材１３に浸けることができるため、製造工程が簡素化し、作業効率を一層向上させることが可能となる。 Further, the catheter 12 and the inner needle 14 are immersed in a predetermined coating material 13 in a state of being overlapped with each other, so that the coating material 13 is applied to the surface. As a result, when the catheter assembly 10 is manufactured, the catheter 12 and the inner needle 14 can be immersed in the coating material 13 in a state of being overlapped with each other, so that the manufacturing process can be simplified and the work efficiency can be further improved.
　また、コーティング材１３は、処置対象に対するカテーテル１２の挿入抵抗を低減する材料である。これにより、カテーテル１２及び内針１４を重ねた多重管１１にコーティング材１３が塗布されていることで、処置対象に対するカテーテル１２の挿入が円滑化する。 Further, the coating material 13 is a material that reduces the insertion resistance of the catheter 12 with respect to the treatment target. As a result, the coating material 13 is applied to the multi-tube 11 on which the catheter 12 and the inner needle 14 are overlapped, so that the catheter 12 can be smoothly inserted into the treatment target.
　また、カテーテル操作部材６０は、カテーテルハブ２０よりも先端側に延在しユーザに操作される操作部（操作板部６１）を有し、コーティング材１３の塗布後にカテーテルハブ２０及びセーフティ部材４０に挿入される。これにより、カテーテル組立体１０の製造時には、カテーテル操作部材６０がない状態で、コーティング材１３を多重管１１に塗布することが可能となり、組立がより一層簡易化し、また製造コストを低減することができる。 Further, the catheter operating member 60 has an operating portion (operating plate portion 61) extending to the distal end side of the catheter hub 20 and being operated by the user, and is applied to the catheter hub 20 and the safety member 40 after the coating material 13 is applied. Will be inserted. As a result, when the catheter assembly 10 is manufactured, the coating material 13 can be applied to the multilayer tube 11 without the catheter operating member 60, which further simplifies the assembly and reduces the manufacturing cost. it can.
　また、セーフティ部材４０がカテーテルハブ２０及び筒部（操作部筒部６３）に挿入される箇所、及び筒部は円筒状に形成されており、筒部の内径は、挿通されているセーフティ部材４０の外径に対して余裕空間６３ａ１を持つ寸法に設定されている。これにより、カテーテル組立体１０は、カテーテル操作部材６０の筒部にセーフティ部材４０を挿通してカテーテルハブ２０に当該セーフティ部材４０を挿入させる際に、セーフティ部材４０をスムーズに入れていくことができる。しかも、セーフティ部材４０と、カテーテル操作部材６０の筒部とが円筒状に形成されている構成では、カテーテルハブ２０にセーフティ部材４０を挿入させる際に相対回転させることができ、挿入及び嵌合を安定的に行うことが可能となる。 Further, the portion where the safety member 40 is inserted into the catheter hub 20 and the tubular portion (operation unit tubular portion 63) and the tubular portion are formed in a cylindrical shape, and the inner diameter of the tubular portion is the safety member 40 through which the safety member 40 is inserted. It is set to a dimension having a margin space 63a1 with respect to the outer diameter of. As a result, the catheter assembly 10 can smoothly insert the safety member 40 when the safety member 40 is inserted into the tubular portion of the catheter operating member 60 and the safety member 40 is inserted into the catheter hub 20. .. Moreover, in the configuration in which the safety member 40 and the tubular portion of the catheter operating member 60 are formed in a cylindrical shape, the safety member 40 can be relatively rotated when the safety member 40 is inserted into the catheter hub 20, and the insertion and fitting can be performed. It is possible to perform it stably.
　また、筒部（操作部筒部６３）の軸方向に沿った長さＬは、カテーテル操作部材６０においてカテーテルハブ２０を収容するハブ収容部６２の軸方向に沿った長さの１／３以上に設定されている。これにより、カテーテル組立体１０は、カテーテル操作部材６０の筒部とセーフティ部材４０が重なり合っている距離が長くなり、カテーテル操作部材６０の操作時にセーフティ部材４０に対するカテーテル操作部材６０の曲がりが抑制される。従って、カテーテル操作部材６０は、セーフティ部材４０をスムーズに移動させることができる。 Further, the length L of the tubular portion (operation unit tubular portion 63) along the axial direction is 1/3 or more of the length along the axial direction of the hub accommodating portion 62 accommodating the catheter hub 20 in the catheter operating member 60. Is set to. As a result, in the catheter assembly 10, the distance between the tubular portion of the catheter operating member 60 and the safety member 40 is increased, and the bending of the catheter operating member 60 with respect to the safety member 40 is suppressed when the catheter operating member 60 is operated. .. Therefore, the catheter operating member 60 can smoothly move the safety member 40.

Claims (9)

  1. 　カテーテルと、
    　前記カテーテルを保持するカテーテルハブと、
    　前記カテーテルに挿通された内針と、
    　前記カテーテル及び前記カテーテルハブの移動をユーザが操作するためのカテーテル操作部材と、
    　前記カテーテルハブ内に挿入されて嵌合することで当該カテーテルハブと共に移動可能であり、処置対象に穿刺した前記内針の針先よりも進出して当該内針の誤刺防止機能を発動するセーフティ部材とを備えるカテーテル組立体であって、
    　前記カテーテル操作部材は、前記セーフティ部材が挿通される挿通空間を有する筒部と、前記筒部の軸方向に延在するスリットとを有し、
    　前記スリットは、前記筒部の側方から前記挿通空間に前記内針を通過可能とする一方で、前記挿通空間から前記筒部の側方への前記セーフティ部材の通過を不能とする
    　カテーテル組立体。     With a catheter
    A catheter hub that holds the catheter and
    The inner needle inserted through the catheter and
    A catheter operating member for the user to operate the catheter and the movement of the catheter hub, and
    Safety that can be moved together with the catheter hub by being inserted into the catheter hub and fitted into the catheter hub, and advances beyond the needle tip of the inner needle punctured by the treatment target to activate the erroneous puncture prevention function of the inner needle. A catheter assembly with members
    The catheter operating member has a tubular portion having an insertion space through which the safety member is inserted, and a slit extending in the axial direction of the tubular portion.
    The slit allows the inner needle to pass from the side of the tubular portion to the insertion space, while disabling the passage of the safety member from the insertion space to the side of the tubular portion. ..
  2. 　請求項１記載のカテーテル組立体において、
    　前記スリットの幅は、前記内針の直径よりも大きく、且つ前記セーフティ部材の幅よりも小さく形成される
    　カテーテル組立体。     In the catheter assembly according to claim 1,
    A catheter assembly formed in which the width of the slit is larger than the diameter of the inner needle and smaller than the width of the safety member.
  3. 　請求項１又は２記載のカテーテル組立体において、
    　前記カテーテルハブは、弁部材が内部に挿入される構成であり、
    　前記セーフティ部材は、前記弁部材の弁孔に挿入され当該弁部材を介して前記カテーテルハブ内に嵌合される
    　カテーテル組立体。     In the catheter assembly according to claim 1 or 2.
    The catheter hub has a configuration in which a valve member is inserted inside.
    The safety member is a catheter assembly that is inserted into a valve hole of the valve member and fitted into the catheter hub via the valve member.
  4. 　請求項１～３のいずれか１項に記載のカテーテル組立体において、
    　前記カテーテル操作部材は、前記カテーテルハブを収容するハブ収容部を有し、ユーザの操作による前記ハブ収容部の移動に伴い前記カテーテルハブ及び前記セーフティ部材を追従させる構成であり、
    　さらに、前記カテーテルハブと前記セーフティ部材の嵌合の解除に基づき前記カテーテルハブから前記ハブ収容部を離脱可能とする
    　カテーテル組立体。     In the catheter assembly according to any one of claims 1 to 3.
    The catheter operating member has a hub accommodating portion for accommodating the catheter hub, and is configured to follow the catheter hub and the safety member as the hub accommodating portion is moved by a user operation.
    Further, a catheter assembly capable of detaching the hub accommodating portion from the catheter hub based on the release of the fitting between the catheter hub and the safety member.
  5. 　請求項１～４のいずれか１項に記載のカテーテル組立体において、
    　前記カテーテル及び前記内針は、相互に重ねた状態で所定のコーティング材に浸けられることで、前記コーティング材が表面に塗布される
    　カテーテル組立体。     In the catheter assembly according to any one of claims 1 to 4.
    A catheter assembly in which the coating material is applied to the surface by immersing the catheter and the inner needle in a predetermined coating material in a state of being overlapped with each other.
  6. 　請求項５記載のカテーテル組立体において、
    　前記コーティング材は、前記処置対象に対する前記カテーテルの挿入抵抗を低減する材料である
    　カテーテル組立体。     In the catheter assembly according to claim 5,
    The coating material is a catheter assembly that is a material that reduces the insertion resistance of the catheter to the treatment target.
  7. 　請求項５又は６記載のカテーテル組立体において、
    　前記カテーテル操作部材は、前記カテーテルハブよりも先端側に延在し前記ユーザに操作される操作部を有し、前記コーティング材の塗布後に前記カテーテルハブ及び前記セーフティ部材に挿入される
    　カテーテル組立体。     In the catheter assembly according to claim 5 or 6.
    The catheter operating member has an operating portion that extends to the distal end side of the catheter hub and is operated by the user, and is a catheter assembly that is inserted into the catheter hub and the safety member after application of the coating material.
  8. 　請求項１～７のいずれか１項に記載のカテーテル組立体において、
    　前記セーフティ部材が前記カテーテルハブ及び前記筒部に挿入される箇所、及び前記筒部は円筒状に形成されており、
    　前記筒部の内径は、挿通されている前記セーフティ部材の外径に対して余裕空間を持つ寸法に設定されている
    　カテーテル組立体。     In the catheter assembly according to any one of claims 1 to 7.
    The location where the safety member is inserted into the catheter hub and the tubular portion, and the tubular portion are formed in a cylindrical shape.
    A catheter assembly in which the inner diameter of the tubular portion is set to a dimension having a margin space with respect to the outer diameter of the safety member to be inserted.
  9. 　請求項１～８のいずれか１項に記載のカテーテル組立体において、
    　前記筒部の軸方向に沿った長さは、前記カテーテル操作部材において前記カテーテルハブを収容するハブ収容部の軸方向に沿った長さの１／３以上に設定されている
    　カテーテル組立体。     In the catheter assembly according to any one of claims 1 to 8.
    A catheter assembly in which the length along the axial direction of the tubular portion is set to 1/3 or more of the length along the axial direction of the hub accommodating portion accommodating the catheter hub in the catheter operating member.
PCT/JP2020/042277 2019-11-14 2020-11-12 Catheter assembly WO2021095808A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002028246A (en) * 2000-07-13 2002-01-29 Mitsubishi Pencil Co Ltd Safety device for intravenous cannula
JP2017176455A (en) * 2016-03-30 2017-10-05 テルモ株式会社 Catheter assembly

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002028246A (en) * 2000-07-13 2002-01-29 Mitsubishi Pencil Co Ltd Safety device for intravenous cannula
JP2017176455A (en) * 2016-03-30 2017-10-05 テルモ株式会社 Catheter assembly

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