WO2022118837A1 - Indwelling needle assembly - Google Patents

Indwelling needle assembly Download PDF

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Publication number
WO2022118837A1
WO2022118837A1 PCT/JP2021/043841 JP2021043841W WO2022118837A1 WO 2022118837 A1 WO2022118837 A1 WO 2022118837A1 JP 2021043841 W JP2021043841 W JP 2021043841W WO 2022118837 A1 WO2022118837 A1 WO 2022118837A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
tip
pusher
hub
valve body
Prior art date
Application number
PCT/JP2021/043841
Other languages
French (fr)
Japanese (ja)
Inventor
弘三 石倉
辰也 工藤
Original Assignee
ニプロ株式会社
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 ニプロ株式会社 filed Critical ニプロ株式会社
Priority to JP2022566933A priority Critical patent/JPWO2022118837A1/ja
Publication of WO2022118837A1 publication Critical patent/WO2022118837A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Definitions

  • the present invention relates to an indwelling needle assembly that is punctured into a blood vessel during infusion, blood sampling, artificial dialysis, or the like.
  • an indwelling needle assembly that is punctured into a blood vessel during infusion, blood sampling, artificial dialysis, etc. has been known.
  • the indwelling needle assembly is provided on the base end side of the inner needle by inserting the inner needle into the outer needle so as to be retractable.
  • the needle hub and the outer needle hub provided on the base end side of the outer needle have a structure in which they are combined with each other. Then, by puncturing the blood vessel together with the inner needle and then pulling out the inner needle from the outer needle, the indwelling needle having the outer needle and the outer needle hub is indwelled in the state of being punctured in the blood vessel.
  • Patent Document 1 proposes an indwelling needle assembly provided with a needle tip protector that protects the needle tip of the inner needle so that the inner needle pulled out from the outer needle is not accidentally re-punctured. That is, Patent Document 1 has a structure in which the protector body arranged on the inner circumference of the outer needle hub moves to the tip of the inner needle by pulling out the inner needle from the outer needle to protect the needle tip of the inner needle. ing.
  • the protector main body when the inner needle is inserted into the outer needle, the protector main body is separated from the inner needle, and when the inner needle is pulled out, the resistance force due to the friction between the inner needle and the protector main body does not act. ing.
  • the action ring attached to the inner peripheral surface of the outer needle hub moves to the tip end side of the protector body, and the action ring deforms the tip portion of the protector body. Move it to a position that covers the tip side of the inner needle. As a result, the needle tip of the inner needle is covered and protected by the protector body.
  • Patent Document 1 since the protector main body is held in a state of protecting the needle tip of the inner needle, the protector main body needs to be deformed by the action ring, so that it is a separate body that can be separated from the outer needle hub. It was necessary to provide an action ring.
  • an indwelling needle assembly provided with a valve body has also been proposed.
  • the slit of the valve body is opened by inserting the tip of the tapered pusher into the slit of the valve body.
  • the indwelling needle assembly having such a structure since the pusher has a diameter that can be inserted into the slit, the internal space of the pusher tends to be narrowed, and the needle tip protector or the like housed inside the pusher or the like. In some cases, the size and shape of the
  • the problem to be solved by the present invention is to provide an indwelling needle assembly having a novel structure capable of solving at least one of the problems inherent in the indwelling needle assembly having the conventional structure as described above.
  • the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be pullable, and the inner needle is pulled out from the outer needle.
  • An indwelling needle assembly provided with a needle tip protector that protects the needle tip of the needle, wherein the needle tip protector has a needle tip protector located laterally away from the inner needle, and the inner needle.
  • a contact portion that leads to a protective position that covers the needle tip
  • a pusher that switches the valve body is arranged inside the outer needle hub on the proximal end side of the valve body, and at least the needle tip protector is provided. A part of it is housed inside the pusher.
  • the needle tip protection portion of the needle tip protector when the inner needle is pulled out from the outer needle, the needle tip protection portion of the needle tip protector is deformed and displaced in the direction approaching the inner needle by the contact portion. The needle tip of the inner needle is covered and protected by the needle tip protection portion.
  • the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub.
  • the pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and at least a part of the needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle is the pusher.
  • the pusher is provided with a small cylinder portion and a large cylinder portion, the large cylinder portion is formed on the tip side of the small cylinder portion, and the large cylinder portion has an internal dimension larger than that of the small cylinder portion. Is made larger.
  • the indwelling needle assembly having a structure according to this aspect, a large space is secured inside the large cylinder portion of the pusher, and the size and shape of the needle tip protector and the like housed inside the large cylinder portion are not easily restricted.
  • the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub.
  • the pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and at least a part of the needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle is the pusher.
  • the pusher is housed in an input portion to which an external force for pressing the pusher against the valve body is input, and an action portion provided on the tip side of the input portion to push the valve body open.
  • the working part has a larger diameter than the input part.
  • an input portion having a diameter smaller than that of the acting portion is provided on the proximal end side, so that, for example, a male is inserted and connected to an outer needle hub from the proximal end opening.
  • the luer is pressed against the base end surface of the pusher, and the external force that pushes the pusher against the valve body is effectively input to the pusher.
  • a force from the valve body to the base end side is likely to be applied to the pusher, and when the external force for pressing the pusher against the valve body is released, the force is released. It becomes easier for the pusher to return to the initial position.
  • the input portion is housed in the luer insertion portion on the proximal end side of the outer needle hub, and the outer diameter dimension of the working portion is large. It is made larger than the inner diameter of the lure insertion portion.
  • the movement toward the base end of the pusher is restricted by the locking of the tip of the luer insertion part and the base end of the action part. Therefore, for example, when the needle tip protector is pulled out to the base end while sliding against the pusher, it is possible to prevent the pusher from being pulled out from the outer needle hub together with the needle tip protector.
  • the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub.
  • the pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and at least a part of the needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle is the pusher.
  • the pusher is housed in an input portion to which an external force for pressing the pusher against the valve body is input, and an action portion provided on the tip side of the input portion to push the valve body open.
  • the working portion having a diameter larger than that of the input portion has an outer dimension larger than the inner dimension of the base end portion of the outer needle hub.
  • the tip portion of the pusher is a large-diameter working portion, a large space is secured inside the working portion and is accommodated inside the working portion. It is difficult to limit the dimensions and shape of the needle tip protector and the like.
  • valve body is formed with a slit that penetrates the inner peripheral portion in the needle axis direction of the inner needle.
  • the outer peripheral end of the working portion is located on the outer periphery of the slit.
  • the indwelling needle assembly having a structure according to this aspect, when the working part is pressed against the valve body, it is possible to prevent the entire working part from entering the slit of the valve body. Therefore, for example, when the opening and closing operation of the valve body by the pusher is repeatedly executed, it is possible to avoid a situation in which the pusher cannot come out of the slit of the valve body and cannot return from the open position to the closed position.
  • the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub.
  • the pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and at least a part of the needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle is the pusher.
  • the pusher Contained inside the pusher, the pusher comprises a tip member attached to an opening on the distal end side of the proximal member, at least a portion of the distal opening of the proximal member. It is blocked by.
  • the internal space of the pusher can be secured by the base end member. Further, even when the needle tip protection protector moves to the tip side due to the tip opening of the accommodating area of the needle tip protection protector in the pusher being blocked at least in a part by the tip member, the needle tip protection is performed. Since the amount of movement of the protector to the tip side is limited by the tip member, it is possible to prevent the needle tip protection protector from interfering with the valve body arranged at the tip rather than the pusher.
  • the tip member includes an insertion portion having a diameter smaller than that of the tip opening of the base end member.
  • the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub.
  • the pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and the opening portion at the tip of the pusher has a flat tubular shape, and the pusher has a flat direction. Insertion protrusions that project toward the tips on both sides and can be inserted into the slits formed in the valve body are formed.
  • the slit is effectively widened by inserting the insertion protrusion of the pusher into the slit of the valve body, and the stable opening operation of the valve body is realized. Will be done. Further, since the large diameter portion of the pusher orthogonal to the flat direction is not inserted into the slit of the valve body, for example, when the valve body is repeatedly opened and closed by the pusher, the insertion protrusion is inserted into the slit. It becomes easy to return from the opened position to the initial closed position.
  • the large-diameter portion orthogonal to the flattening direction of the pusher is pressed against the outer peripheral portion of the valve body without being inserted into the slit, so that the elastic restoring force of the valve body moves the pusher to the closed position. It acts in the direction of making the pusher move from the open position to the closed position of the pusher more stably.
  • the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub.
  • the pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and is provided with a needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle.
  • the opening portion at the tip of the needle has a flat tubular shape, and a protector accommodating portion for accommodating at least a part of the needle tip protector is provided inside the pusher having a flat tubular shape. Is.
  • the wasted space in the pusher when the needle tip protector is housed can be reduced especially in the flat direction, and the dimensions of the needle tip protector are limited. It is possible to reduce the size of the pusher and the outer needle hub without doing so.
  • the flat tubular shape means a cylindrical shape in which the external dimensions in the cross-sectional shape in the direction perpendicular to the axis are different from each other in the two orthogonal directions.
  • the eleventh aspect is the indwelling needle assembly according to the tenth aspect, and the pusher can be inserted into a slit formed in the valve body so as to project toward the tip on both sides in the flat direction.
  • the insertion protrusion is provided.
  • a stable opening operation of the valve body is realized by inserting the insertion protrusion of the pusher into the slit of the valve body.
  • FIG. 3 is a cross-sectional view showing a tip portion of an inner needle constituting the indwelling needle assembly of FIG.
  • Right side view of the needle tip protector shown in FIG. Bottom view of the needle tip protector shown in FIG. IX-IX sectional view of FIG. It is sectional drawing which shows the part of the indwelling needle assembly of FIG.
  • FIG. 1 is a cross-sectional view showing a part of the indwelling needle assembly of FIG. 1, showing a state in which the needle tip is protected by a needle tip protector while the inner needle is being pulled out.
  • FIG. 1 is an enlarged cross-sectional view showing a part of the indwelling needle assembly of FIG. 1, showing a state in which the inner needle unit is separated from the indwelling needle. It is sectional drawing which shows the part of the indwelling needle assembly as 2nd Embodiment of this invention, and corresponds to the XIV-XIV sectional
  • FIG. 14 is a cross-sectional view taken along the line XV-XV.
  • FIG. 16 A perspective view of a pusher constituting the indwelling needle assembly of FIG.
  • FIG. 16 A perspective view showing the pusher of FIG. 16 at another angle.
  • the indwelling needle assembly 10 has a structure in which the inner needle 14 constituting the inner needle unit 12 is inserted into the outer needle 18 constituting the indwelling needle 16 and the inner needle unit 12 and the indwelling needle 16 are combined.
  • the vertical direction refers to the vertical direction in FIG. 1
  • the horizontal direction refers to the vertical direction in FIG. 3.
  • the left side in FIG. 1, which is distal to the distal end side, and the right side in FIG. 1, which is proximal to the proximal end side are referred to.
  • the inner needle unit 12 has a structure in which the inner needle hub 20 is fixed to the inner needle 14.
  • the inner needle 14 is a hard member made of metal or the like, and is a hollow needle in the present embodiment.
  • the tip surface of the inner needle 14 is cut into an inclined shape, and a sharp needle tip 22 is formed.
  • the tip portion of the inner needle 14 is provided with a closing portion 24 for blocking the lumen.
  • a pair of locking protrusions 26, 26 protruding from the outer peripheral surface are formed at the tip portion of the inner needle 14.
  • the locking projection 26 projects in the left-right direction (vertical direction in FIGS. 3 and 4), and is formed by, for example, partially crushing the inner needle 14 in the vertical direction.
  • the locking projection 26 is provided in the closing portion 24 of the inner needle 14, but the locking projection 26 may be provided in the hollow portion of the inner needle 14 that is out of the closing portion 24. Further, the inner needle 14 does not have to be provided with the closing portion 24, and for example, the lumen of the inner needle 14 may be formed so as to penetrate from the tip end to the base end.
  • the inner needle hub 20 includes a hub main body 28 as shown in FIGS. 1 to 3.
  • the hub body 28 has a substantially rectangular tubular shape at the tip end portion and a substantially cylindrical shape at the base end portion.
  • the outer peripheral surface of the tip portion of the hub body 28 is curved in the axial direction and has a small diameter from both ends in the axial direction toward the center, so that the fingers do not slip easily when being picked up by fingers and moved in the axial direction.
  • the hub main body 28 integrally includes a substantially cylindrical inner needle holding portion 30 that protrudes from the inner peripheral surface of the tip portion and extends toward the base end.
  • the inner peripheral surface of the inner needle holding portion 30 is adhered to the outer peripheral surface of the inner needle 14, and the hub main body 28 is fixed to the inner needle 14.
  • the tip of the hub body 28 is provided with a flange-shaped portion 32 projecting toward the outer periphery, so that the tip surface of the hub body 28 has an inner diameter smaller and an outer diameter larger than the base end surface of the outer needle hub 36 described later. ing.
  • a cap member 34 is attached to the base end opening portion of the hub main body 28.
  • the cap member 34 has a substantially cylindrical shape as a whole.
  • the cap member 34 has a tapered outer peripheral surface in which the tip portion having a small diameter is reduced in diameter toward the tip, and the tip portion is fitted to the base end opening portion of the hub body 28 to fit the hub body. It is attached to 28.
  • a breathable filter 35 is attached to the base end opening portion of the cap member 34, and the air inside the cap member 34 can be discharged to the outside through the breathable filter 35, while being inside by, for example, flashback at the time of puncture. Blood that has entered the inside of the cap member 34 through the needle 14 does not pass through the breathable filter 35 and does not leak from the inside of the cap member 34.
  • the cap member 34 is preferably transparent or translucent so that the flashback at the time of puncturing the blood vessel of the inner needle 14 can be easily visually recognized.
  • the indwelling needle 16 has a structure in which the outer needle hub 36 is provided at the base end of the outer needle 18.
  • the outer needle 18 is a hollow needle made of resin or metal. It is desirable that the outer needle 18 has a tapered surface whose outer peripheral surface of the tip portion has a smaller diameter toward the tip.
  • the base end portion of the outer needle 18 is inserted into the inner circumference of the tubular outer needle hub 36 and fixed to the outer needle hub 36.
  • the outer needle hub 36 is, for example, a resin tubular body.
  • the outer needle hub 36 of the present embodiment has a structure in which a needle fixing member 38 constituting a tip portion and a luer connecting member 40 constituting a base end portion are combined.
  • the outer needle hub 36 may be entirely composed of one component, or may be configured by combining three or more components. Further, when a plurality of parts are combined to form the outer needle hub 36, these parts may be fixed by being fitted by being non-adhesive, or may be fixed by means such as adhesion or welding. May be good.
  • the needle fixing member 38 has a cylindrical shape as a whole, and has a tapered portion 42 having a large diameter toward the proximal end in the middle of the axial direction, and the proximal end side of the tapered portion 42 has a larger diameter than the tip end side. It is said that.
  • the needle fixing member 38 is formed with engaging holes 44, 44 penetrating in the vertical direction, and is provided with a tapered inner peripheral surface whose proximal end side expands toward the proximal end with respect to the engaging hole 44. There is. Then, the outer needle 18 is inserted into the tip portion of the needle fixing member 38 having a small diameter, and the outer needle 18 is fixed to the needle fixing member 38 by a cylindrical pin.
  • the luer connecting member 40 is cylindrical as a whole, and a step 46 is provided in the middle in the axial direction, and the tip side of the step 46 is a hub connecting portion 48 having a large diameter, and the base end side has a small diameter. It is said to be the lure insertion portion 50 of the above.
  • a pair of engaging claws 52 are provided on the outer peripheral surface of the hub connecting portion 48, and the engaging claws 52 are engaged with the inner surface of the engaging hole 44 provided in the needle fixing member 38.
  • the needle fixing member 38 and the luer connecting member 40 are connected to form the outer needle hub 36.
  • the inner peripheral surface of the luer insertion portion 50 has a luer taper that expands in diameter toward the base end.
  • the pusher 54 is housed in the luer connecting member 40 of the outer needle hub 36.
  • the pusher 54 has a substantially stepped cylindrical shape as a whole, and has a protector accommodating portion 55 penetrating in the axial direction inside.
  • the pusher 54 has an input portion 56 whose base end portion is a small cylinder portion having a small diameter, and an action portion 58 whose tip portion is a large cylinder portion having a larger diameter than the input portion 56.
  • the input portion 56 and the action portion 58 are formed by a stepped contact portion 60 that protrudes toward the inner circumference of the outer needle hub 36 and the pusher 54 at the base end of the action portion 58 located inside the outer needle hub 36. It is provided integrally and continuously.
  • the shape of the inner peripheral surface of the pusher 54 is a quadrangle corresponding to the first needle insertion portion 68 of the needle tip protector 66 described later in the input portion 56, and is circular in the action portion 58.
  • the protruding dimension of the contact portion 60 from the acting portion 58 changes in the circumferential direction.
  • the internal dimension of the working portion 58 in the direction perpendicular to the axis is larger than the internal dimension of the input portion 56 in the direction perpendicular to the axis. Therefore, the protector accommodating portion 55 provided on the inner circumference of the pusher 54 has a tip portion having a larger diameter than the base end portion.
  • the shape of the inner peripheral surface of the input unit 56 is not limited to a quadrangle, but preferably, the inner diameter dimension such as an ellipse or a polygon is in the circumferential direction so as to prevent the needle tip protector 66 from rotating. It is said that the shape has changed with.
  • the pusher 54 may be appropriately provided with a slit (hole) or the like that penetrates the peripheral wall.
  • the input portion 56 is housed in the luer insertion part 50 of the luer connecting member 40, and the working part 58 is housed in the hub connecting part 48 of the luer connecting member 40.
  • the input portion 56 of the pusher 54 extends with a substantially constant outer diameter, and a gap is formed between the inner peripheral surface of the luer insertion portion 50 having a luer taper and the outer peripheral surface of the input portion 56.
  • the pusher 54 is positioned in a direction perpendicular to the axis of the outer needle hub 36 by superimposing the outer peripheral surface of the acting portion 58 on the inner peripheral surface of the hub connecting portion 48 of the outer needle hub 36.
  • the outer dimension of the acting portion 58 is larger than the inner dimension of the luer insertion portion 50 constituting the proximal end portion of the outer needle hub 36, and the proximal end surface of the acting portion 58 is the outer needle.
  • the base end of the pusher 54 is located on the tip side of the base end of the outer needle hub 36 (lure connecting member 40), and the pusher 54 is accommodated without protruding from the outer needle hub 36 to the base end. There is.
  • a valve body 62 is arranged on the tip end side of the pusher 54 inside the outer needle hub 36.
  • the valve body 62 is formed of a resin elastomer or rubber having rubber-like elasticity.
  • the valve body 62 has a substantially disk shape, and the outer peripheral end portion is sandwiched between the needle fixing member 38 constituting the outer needle hub 36 and the luer connecting member 40 in the thickness direction to obtain an outer needle. It is arranged so as to block the lumen of the hub 36.
  • the valve body 62 includes a slit 64 that penetrates the inner peripheral portion.
  • the slit 64 extends radially from the center of the valve body 62, for example, and penetrates the valve body 62 in the left-right direction in FIG. 2, which is the needle axis direction of the inner needle 14. Then, the lumen of the outer needle hub 36 is switched between a communication state through the slit 64 and a blocking state by opening and closing the slit 64 of the valve body 62.
  • the pusher 54 is arranged on the base end side of the valve body 62, and the outer peripheral edge of the tip of the acting portion 58 of the pusher 54 is located on the outer peripheral side of the outer peripheral end of the slit 64 of the valve body 62.
  • the outer peripheral end of the tip surface of the pusher 54 is located on the outer periphery of the slit 64.
  • the inner peripheral edge of the tip of the acting portion 58 is located on the outer peripheral side of the outer peripheral end of the slit 64, and the entire tip surface of the acting portion 58 is located off the outer periphery of the slit 64.
  • the tip of the pusher 54 may be in contact with the valve body 62 supported by the outer needle hub 36, but in the present embodiment, the tip is located away from the base end with respect to the valve body 62.
  • the protector accommodating portion 55 provided inside the pusher 54 accommodates the needle tip protector 66 as shown in FIGS. 5 to 9.
  • the entire needle tip protector 66 is located inside the pusher 54, preventing the outer needle hub 36 from becoming larger.
  • the needle tip protector 66 is formed of, for example, an elastically deformable metal plate material.
  • the needle tip protector 66 includes a first needle insertion portion 68 extending substantially orthogonal to the needle axis direction of the inner needle 14 at the base end.
  • the first needle insertion portion 68 has a rectangular plate shape, and a first circular hole 70 corresponding to the outer shape of the inner needle 14 is formed in the center so as to penetrate in the thickness direction.
  • the diameter of the first circular hole 70 is larger than the outer diameter of the inner needle 14 at the portion where the locking protrusions 26, 26 are removed, and is larger than the outer diameter dimension of the inner needle 14 at the portion where the locking protrusions 26, 26 are formed. Has also been made smaller.
  • the needle tip protector 66 includes a pair of needle tip protection portions 72a and 72b.
  • the pair of needle tip protection portions 72a and 72b extend from the upper and lower ends of the first needle insertion portion 68 toward the tip.
  • the needle tip protection portion 72a includes an elastic plate portion 74a extending from the upper end portion of the first needle insertion portion 68 toward the tip end.
  • the first portion 76a which is the base end portion
  • the second portion 78a which is the intermediate portion
  • the portion 80a is tilted downward toward the tip.
  • the needle tip protection portion 72a includes a folded portion 82a in which the tip end portion of the third portion 80a is folded downward toward the base end.
  • a pair of side wall portions 84, 84 are provided on the tip portion of the needle tip protection portion 72a so as to face each other in the left-right direction.
  • the side wall portion 84 extends from the third portion 80a of the elastic plate portion 74a.
  • the side wall portion 84 has a tapered shape in which the protrusion dimension from the needle tip protection portion 72a becomes smaller toward the tip in the lateral view shown in FIG. 7. Since the notch 85 is formed between the folded-back portion 82a and the side wall portion 84 of the needle tip protection portion 72a, the side wall portion 84 is not excessively restrained by the folded-back portion 82a and is deformed by bending in the thickness direction. Is allowed.
  • a locking piece 86 is integrally provided on each of the pair of side wall portions 84 and 84 of the needle tip protection portion 72a.
  • the locking piece 86 extends along the protruding tip of the side wall portion 84, and protrudes inward in the facing direction of the pair of side wall portions 84, 84. As shown in FIG. 9, the locking piece 86 is inclined toward the elastic plate portion 74a in the thickness direction toward the protruding tip.
  • the needle tip protection portion 72b includes an elastic plate portion 74b extending from the lower end portion of the first needle insertion portion 68 toward the tip end.
  • the first portion 76b which is the base end portion
  • the second portion 78b which is the intermediate portion
  • the third portion is the tip portion.
  • the portion 80b is tilted upward toward the tip.
  • the needle tip protection portion 72b includes a folded portion 82b in which the tip end portion of the third portion 80b is folded upward toward the base end.
  • the folded portion 82a of the needle tip protection portion 72a and the folded portion 82b of the needle tip protection portion 72b are separated from each other in the vertical direction in the projection in the needle axis direction.
  • the length of the needle tip protection portion 72b from the first needle insertion portion 68 to the tip is shorter than that of the needle tip protection portion 72a. As shown in FIG. 8, the tip of the needle tip protection portion 72b reaches the locking piece 86 of the needle tip protection portion 72a and does not reach the folded portion 82a of the needle tip protection portion 72a. Further, the width dimension of the third portion 80b of the needle tip protection portion 72b in the left-right direction is smaller than that of the third portion 80a of the needle tip protection portion 72a. The width dimension of the third portion 80b is smaller than the distance between the pair of side wall portions 84 and 84 and larger than the distance between the pair of locking pieces 86 and 86.
  • the needle tip protector 66 is provided with a positioning portion 88 between the pair of needle tip protection portions 72a and 72b facing each other.
  • the positioning portion 88 includes a support portion 90 extending from the first needle insertion portion 68 toward the tip, and a second needle insertion portion 92 facing substantially parallel to the first needle insertion portion 68 on the tip side.
  • the structure is such that the first needle insertion portion 68 and the second needle insertion portion 92 are integrally connected by a support portion 90.
  • a second circular hole 94 is formed in the second needle insertion portion 92 so as to penetrate in the thickness direction.
  • the second circular hole 94 has a diameter larger than that of the first circular hole 70, and has a diameter that allows the locking projections 26, 26 of the inner needle 14 to easily pass through when the inner needle 14 is pulled out. ..
  • the needle tip protector 66 is housed in the protector accommodating portion 55 of the pusher 54. That is, the first needle insertion portion 68, the first portions 76a, 76b of the pair of needle tip protection portions 72a, 72b, and the base end portion of the positioning portion 88 are inserted into the tip portion of the input portion 56 of the pusher 54. Has been done. Further, the second portions 78a and 78b and the third portions 80a and 80b of the pair of needle tip protection portions 72a and 72b, and the tip portion of the positioning portion 88 including the second needle insertion portion 92 are the acting portions of the pusher 54. It is inserted in 58.
  • the needle tip protector 66 Since the base end portion of the needle tip protector 66 is inserted into the input portion 56 having a quadrangular inner peripheral cross-sectional shape and having a small diameter, the needle tip protector 66 is positioned in the direction perpendicular to the axis with respect to the pusher 54. It is designed to prevent rattling and misalignment. Further, since the tip portion of the needle tip protector 66 is housed in the working portion 58 having a wide internal space, the pair of needle tip protection portions 72a and 72b are held in the pusher 54 in a state where they are separated from each other in the initial shape. It is contained.
  • the needle tip protector 66 While the needle tip protector 66 is housed in the protector accommodating portion 55 of the pusher 54 inside the outer needle hub 36, the second portions 78a and 78b of the pair of needle tip protection portions 72a and 72b and the pusher 54 are hit.
  • the tangent portion 60 is arranged at an overlapping position in the projection in the needle axis direction.
  • the vertical outer ends of the pair of needle tip protection portions 72a and 72b (the boundary portion between the second portion 78 and the third portion 80) are up and down with respect to the vertical inner end of the contact portion 60. It is located outside the direction.
  • the inner needle unit 12 and the indwelling needle 16 are combined with each other to form the indwelling needle assembly 10. That is, the inner needle 14 is inserted into the indwelling needle 16 from the proximal end side, and penetrates the indwelling needle 16 so that the needle tip 22 protrudes from the tip opening of the outer needle 18.
  • the inner needle hub 20 of the inner needle unit 12 is abutted from the base end side in the axial direction with respect to the base end surface of the outer needle hub 36, whereby the amount of protrusion of the inner needle 14 from the outer needle 18 to the tip is increased. It is stipulated.
  • the inner needle 14 penetrates the needle tip protector 66. That is, the inner needle 14 inserted from the proximal end side with respect to the indwelling needle 16 has a first circular hole 70 of the first needle insertion portion 68 of the needle tip protector 66 and a second circular hole 94 of the second needle insertion portion 92. And penetrates between the folded portions 82a and 82b of the pair of needle tip protection portions 72a and 72b toward the tip side.
  • the needle tip protector 66 moves in the direction perpendicular to the axis of the inner needle 14.
  • the pair of needle tip protection portions 72a and 72b are separated from the inner needle 14 in the vertical direction in the initial shape of the needle tip protector 66 on which no external force is applied, and are separated from the needle tip protector 66 of the inner needle 14 in the vertical direction.
  • the inner needle 14 can move smoothly without causing frictional resistance due to contact between the inner needle 14 and the pair of needle tip protection portions 72a, 72b (folded portions 82a, 82b).
  • the pair of needle tip protection portions 72a and 72b are arranged at a separation distance larger than the vertical width dimension of the inner needle 14 in the initial shape, the inner needle 14 is placed from the base end side with respect to the needle tip protector 66. When inserting, it is not necessary to spread between the pair of needle tip protection portions 72a and 72b, and the insertion work of the inner needle 14 is facilitated.
  • the indwelling needle 16 is moved to the blood vessel by pulling out the inner needle 14 from the outer needle 18 after the inner needle 14 and the outer needle 18 are punctured into the blood vessel of the patient. It is indwelled in a punctured state.
  • the needle tip 22 of the inner needle 14 pulled out from the outer needle 18 is protected by the needle tip protector 66. That is, as shown in FIG. 10, the needle tip 22 of the inner needle 14 pulled out from the outer needle 18 moves between the pair of needle tip protection portions 72a and 72b of the needle tip protector 66. Then, the locking projections 26 and 26 of the inner needle 14 are axially locked with respect to the first needle insertion portion 68. In the inner needle 14, the needle tip 22 is located on the tip side of the second needle insertion portion 92 and is kept in the inserted state without coming out of the second circular hole 94, so that the runout of the needle tip 22 is suppressed. There is.
  • the needle tip protector 66 moves toward the base end side together with the inner needle 14, and the needle tip protector 66 passes through the input portion 56 of the pusher 54.
  • the second portions 78a and 78b of the pair of needle tip protection portions 72a and 72b abut on the contact portion 60 of the pusher 54, and the pair of needle tip protection portions
  • the elastic plate portions 74a and 74b of 72a and 72b are deformed and approach each other. As a result, the needle tip protection portion 72b is pressed against the locking pieces 86, 86 by the needle tip protection portion 72a.
  • the locking pieces 86, 86 are inclined inward in the width direction toward the needle tip protection portion 72a, the locking pieces 86, 86 are locked by being pressed against the locking pieces 86, 86 by the needle tip protection portion 72a.
  • a force that pushes the pieces 86 and 86 apart from each other acts on the pieces 86 and 86.
  • the side wall portions 84, 84 supporting the locking pieces 86, 86 are elastically deformed, the space between the locking pieces 86, 86 is expanded, and the needle tip protection portion 72b is between the locking pieces 86, 86. It moves to the needle tip protection portion 72a side from the locking pieces 86, 86 (see FIGS. 11 and 12).
  • the locking pieces 86, 86 return to their initial positions due to the elasticity of the side wall portions 84, 84 when the force to push them out through the needle tip protection portion 72b is released. Then, both ends of the needle tip protection portion 72b in the width direction are locked to the locking pieces 86, 86, and the needle tip protection portion 72a and the needle do not pass between the locking pieces 86, 86 again.
  • the pre-protection portion 72b is held at an approaching position close to each other. As described above, in the present embodiment, the needle tip protection portion 72a and the needle tip protection portion 72b are locked by locking the elastic plate portion 74b of the needle tip protection portion 72b and the locking pieces 86, 86 of the needle tip protection portion 72a.
  • a holding mechanism for holding the needles in close proximity to each other is configured. Therefore, in the present embodiment, the locking pieces 86, 86 of the needle tip protection portion 72a and the widthwise end portion of the elastic plate portion 74b of the needle tip protection portion 72b are regarded as locking portions that are mutually locked.
  • the holding mechanism is configured by the locking portion.
  • the holding mechanism is integrally provided on the needle tip protector 66. When the needle tip protection portion 72a and the needle tip protection portion 72b are displaced in the approaching direction, the urging force may be generated in the approaching direction, or conversely, the urging force may be generated in the separating direction. It may be good, or it may be possible to prevent the force from being generated.
  • the needle tip protection portion is not limited to the structure of the embodiment, and a needle tip protection portion having a known structure can be appropriately selected and adopted.
  • the tip portion of the needle tip protection portion 72b that has moved to a position closer to the needle tip protection portion 72a by pulling out the inner needle 14 covers the needle tip 22 of the inner needle 14 on the tip side.
  • the tip portion of the needle tip protection portion 72b that has moved to the approach position shown in FIG. 11 is located on the extension line toward the tip side of the inner needle 14.
  • the needle tip protection portions 72a and 72b are designed to protect the needle tip 22 of the inner needle 14 at an approaching position close to each other, and the approaching position of the needle tip protection portions 72a and 72b is the needle tip 22. It is said to be a protective position to protect. Since the needle tip protection portions 72a and 72b of the present embodiment are provided with folded portions 82a and 82b at the tip portions, even if the needle tip 22 moves along the elastic plate portions 74a and 74b, the needle tip 22 Is received by the folded-back portions 82a and 82b, so that the movement is restricted and the needle tip 22 does not re-protrude.
  • the side wall portions 84, 84 of the needle tip protection portion 72a at the protection position are arranged on both the left and right sides with respect to the needle tip 22 of the inner needle 14, and the needle tip 22 is exposed to the tip side by the elastic plate portions 74a, 74b. It is prevented not only on both the upper and lower sides but also on both the left and right sides.
  • the tip portion of the needle tip protector 66 has a bag shape, and the needle tip 22 has the bag-shaped tip portion.
  • the outer peripheral side and the tip side of the needle tip 22 are both covered with the needle tip protector 66. Therefore, even if the needle tip 22 swings in the vertical direction or the horizontal direction, the movement of the needle tip 22 stays in the bag-shaped tip portion of the needle tip protector 66, and the needle tip 22 touches the patient or the medical staff. Can be prevented.
  • the pair of needle tip protection portions 72a and 72b of the needle tip protector 66 are closed close to each other by contacting the stepped portion (contact portion 60) of the pusher 54 from the initial position separated from each other.
  • the needle tip 22 may be covered by being deformed to a position.
  • the needle tip 22 may be covered. Elastic restoration to the initial position may be prevented.
  • the base end portions of the pair of needle tip protection portions 72a and 72b are provided with spring characteristics as a curved cross-sectional shape, so that the initial position separated from each other and the protected position closed close to each other are preferably used.
  • the initial position and the protection position are selectively elastically deformed, and the shape is stably maintained in either the initial position or the protection position.
  • the pair of needle tip protection Even when the shapes of the portions 72a and 72b are maintained in the protective position, it is desirable to provide a locking mechanism for preventing the pair of needle tip protection portions 72a and 72b from being deformed in the direction of mutual separation.
  • the inner needle 14 whose needle tip 22 is protected by the needle tip protector 66 is pulled out toward the proximal end side with respect to the outer needle hub 36 and is separated from the outer needle hub 36 as shown in FIG. Since the holding mechanism is provided on the needle tip protection portions 72a and 72b of the needle tip protector 66, even if the needle tip protector 66 is separated from the outer needle hub 36, the needle tip protection portions 72a and 72b are close to each other. It is held in the protected position and the needle tip 22 is protected by the needle tip protector 66. As described above, since the holding mechanism for holding the needle tip protection portions 72a and 72b at the protective position is provided on the needle tip protector 66 itself, the needle tip protection portion of the needle tip protector 66 separated from the outer needle hub 36 is provided.
  • the needle tip protector 66 may be accommodated in a close state and a guide portion may be provided to guide the needle tip protector 66 so that the needle tip protector 66 can be smoothly pulled out when the needle tip protector 66 is separated from the outer needle hub 36.
  • the guide portion may be, for example, the contact portion 60 of the pusher 54, but for example, by being provided in a state in which the guide portion can be guided to the needle tip protector 66, the guide portion abuts on the needle tip protector 66. It does not have to be.
  • the indwelling needle 16 separated from the inner needle unit 12 is indwelled with the outer needle 18 punctured into the blood vessel of the patient.
  • an infusion line, a connector, a syringe, or the like (not shown) is connected to the base end portion of the outer needle hub 36.
  • the male luer of the connector or syringe connected to the outer needle hub 36 is inserted into the luer insertion portion 50 of the outer needle hub 36 and pressed against the base end of the input portion 56 of the pusher 54 to the input portion 56.
  • An external force that moves the pusher 54 toward the tip side is applied, and the pusher 54 is pushed toward the tip end.
  • the acting portion 58 of the pusher 54 is pressed against the valve body 62.
  • the valve body 62 is elastically deformed, the slit 64 of the valve body 62 is pushed open, and the inside of the patient's blood vessel and the infusion line, the syringe, etc. are communicated with each other through the opened slit 64, and the indwelling needle 16 is used. Infusion and medication are possible through.
  • the outer peripheral end of the acting portion 58 is located outside the outer peripheral end of the slit 64, and the outer peripheral portion of the valve body 62 is inserted without the acting portion 58 being inserted into the slit 64. Press. Therefore, for example, when the infusion line or syringe is removed from the outer needle hub 36 and the pusher 54 is released from being pushed by the male luer, the pusher 54 is based on the elastic restoring force of the valve body 62. It moves to the end side, and the closing operation of the valve body 62 is realized. As a result, the valve body 62 can be stably opened and closed in the indwelling needle 16 which can be used frequently in the indwelling state.
  • FIGS. 14 and 15 show a part of the indwelling needle assembly 100 as the second embodiment of the present invention.
  • the members and parts substantially the same as those in the first embodiment are designated by the same reference numerals in the drawings, and the description thereof will be omitted.
  • the portions not shown in FIGS. 14 to 18 are the same as those of the first embodiment.
  • the indwelling needle assembly 100 includes a pusher 102.
  • the pusher 102 has a small-diameter cylindrical input portion 56 having a cylindrical outer peripheral surface and an inner peripheral surface having a square cross section at the base end portion, and the tip portion is a cylinder.
  • the working portion 104 has a substantially oval inner shape and an outer shape in which the left-right direction is the short axis direction and the vertical direction is the long axis direction.
  • the pusher 102 has a flat shape in which the opening portion at the tip formed by the acting portion 104 has a minimum portion and a maximum portion having a diameter dimension set in two orthogonal directions.
  • the tip portion of the wall portion formed by the working portion 104 has an internal dimension in the vertical direction larger than the internal dimension in the horizontal direction. It has a flat shape.
  • the outer peripheral surface of the working portion 104 in the minor axis direction is a plane extending substantially orthogonal to the minor axis direction.
  • the outer peripheral surface of the working portion 104 in the major axis direction is a curved surface that curves in an arc shape in the circumferential direction.
  • the inner peripheral surface of the working portion 104 has a cross-sectional shape corresponding to the outer peripheral surface, and the width dimension in the minor axis direction is substantially the same as the width dimension in the same direction of the input portion 56.
  • the flat shape of the tip opening portion of the pusher 102 is not limited to an elliptical shape or an oval shape as illustrated, and may be, for example, a rectangular tubular shape.
  • a pair of insertion protrusions 106, 106 are formed on the tip surface of the working portion 104.
  • the insertion protrusions 106 are provided on both sides of the working portion 104 in the flat direction (minor axis direction), respectively.
  • the cross-sectional shape of the insertion protrusion 106 is not particularly limited, but has a shape and dimensions that can be inserted into the slit 64 of the valve body 62, and is preferably a width in the vertical direction which is the opening / closing direction of the slit 64 of the valve body 62. The dimension is made larger than the width dimension in the left-right direction.
  • the insertion protrusion 106 of the present embodiment extends in the axial direction in a substantially oval cross section in which both end surfaces in the vertical direction are curved surfaces, and the vertical direction which is the opening / closing direction of the slit 64 in the vertical cross section is the long axis direction. It is said that.
  • the tip surface of the insertion protrusion 106 is a flat surface that extends orthogonally to the axial direction. For example, in order to improve the ease of insertion into the slit 64, the tip surface is tapered in the vertical direction toward the tip. It may be a shape or the like.
  • Each insertion protrusion 106 is arranged in the radial direction on the tip surface of the action portion 104 so that the separation distance becomes small, so that a predetermined portion of the valve body 62 can be strongly pressed.
  • each insertion protrusion 106 may be provided above and below (up and down in FIG. 16) the tip surface of the action portion 104 where the separation distance becomes large.
  • the number of insertion protrusions 106 may be only one instead of a plurality.
  • the insertion protrusion 106 may not be provided.
  • the insertion protrusion 106 may be continuously provided on the inner edge of the tip surface of the action portion 104 in a circumferential shape so that the inside of the valve body 62 in contact with the tip surface of the action portion 104 is displaced more greatly.
  • the pusher 102 is housed inside the outer needle hub 36, and the needle tip protector 66 is housed inside. Since the needle tip protector 66 has a second portion 78a, 78b in which the needle tip protection portions 72a, 72b are inclined up and down and outward toward the tip in the initial shape before protecting the needle tip 22, the needle tip protector 66 has a needle tip.
  • the outer dimensions are larger than those in the left-right direction in the vertical direction, which is the direction in which the protective portions 72a and 72b face each other.
  • the gap between the needle tip protector 66 and the inner surface of the acting portion 104 is reduced. Will be done.
  • the pusher 102 provided with the protector accommodating portion 55 and the outer needle hub 36 accommodating the pusher 102 can be miniaturized. In particular, in the left-right direction, which is the flat direction of the working portion 104, miniaturization of the pusher 102 or the like can be easily realized.
  • the slit 64 can be expanded more and surely opened by being inserted into the slit 64.
  • the slit 64 is a single character extending in the left-right direction and is designed to open in the vertical direction, but it may also be a slit extending radially in a plurality of directions such as a Y-shape or a cross.
  • the portions of the tip surface of the pusher 102 that are out of the insertion protrusions 106 and 106 are pressed against the base end surface of the valve body 62 on the outer periphery of the slit 64.
  • the valve body 62 is pushed toward the tip side by the pusher 102 and is elastically deformed.
  • the pusher 102 is pushed back to the base end side based on the elasticity of the valve body 62.
  • the acting portion 104 has a larger outer diameter than the input portion 56, and the acting portion 104 presses the outer peripheral side of the valve body 62.
  • the force toward the proximal end is easily transmitted, and the pusher 102 is stably pushed back to the proximal end side. In this way, the pusher 102 moves toward the proximal end due to the elasticity of the valve body 62, so that the insertion protrusions 106, 106 inserted into the slit 64 come out of the slit 64.
  • the slit 64 is closed and communication between the inside and the outside of the blood vessel is blocked.
  • valve body 62 it is possible to prevent the valve body 62 from being opened and closed in response to the attachment / detachment of an infusion line or an external line such as a syringe to the indwelling needle 16 so that the valve body 62 once opened cannot be closed.
  • FIG. 19 shows a part of the indwelling needle assembly 110 as the third embodiment of the present invention.
  • the indwelling needle assembly 110 includes a pusher 112.
  • the parts not shown in FIGS. 19 and 20 are the same as those of the first embodiment.
  • the pusher 112 includes a pusher body 114 as a base end member and an opening / closing member 116 as a tip member attached to an opening on the tip end side of the pusher body 114. ..
  • the pusher body 114 and the opening / closing member 116 are independently formed as separate members, and for example, the pusher 112 is formed by being fixed to each other by means such as adhesion, welding, fitting, and caulking. There is.
  • the pusher main body 114 has the same structure as the pusher 54 of the first embodiment, and includes an input unit 56 and an action unit 58.
  • the opening / closing member 116 includes a substantially disk-shaped mounting portion 118 having substantially the same outer diameter as the working portion 58, and the mounting portion 118 covers the tip opening of the pusher main body 114.
  • the opening / closing member 116 is provided with a through hole 120 that penetrates the central portion in the thickness direction, and is an insertion cylinder portion 122 as an insertion portion in which the opening peripheral portion of the through hole 120 projects from the mounting portion 118 toward the tip end. ing.
  • the insertion cylinder portion 122 has a substantially cylindrical shape having a smaller diameter than the mounting portion 118, and can be inserted into the slit 64 of the valve body 62.
  • the insertion cylinder portion 122 of the present embodiment has a cylindrical shape extending with a substantially constant outer diameter, but for example, the insertion cylinder portion is moved to the tip thereof in order to make it easier to insert and remove from the slit 64. It can also be a tapered cylinder that tapers toward it.
  • the pusher 112 is housed inside the outer needle hub 36, and the needle tip protector 66 is housed inside. Then, when a male luer (not shown) is inserted into the indwelling needle 16 and the pusher 112 is pushed toward the tip side, the insertion tube portion 122 provided at the tip of the pusher 112 inserts the slit 64 of the valve body 62. It is inserted into the slit 64 while being pushed open. As a result, the slit 64 of the valve body 62 is expanded by the insertion cylinder portion 122 of the pusher 112, and the slit 64 is opened.
  • the tip surface of the mounting portion 118 deviating from the insertion cylinder portion 122 to the outer periphery is pressed against the base end surface of the valve body 62 on the outer periphery rather than the slit 64.
  • the valve body 62 in the open state is pushed toward the tip side by the pusher 112 and is elastically deformed. Then, when the male lure is removed from the outer needle hub 36 and the external force for pushing the pusher 112 toward the tip end side is released, the pusher 112 is pushed back to the base end side based on the elasticity of the valve body 62.
  • the pusher 112 moves toward the proximal end due to the elasticity of the valve body 62, so that the insertion cylinder portion 122 inserted into the slit 64 comes out of the slit 64.
  • the slit 64 is closed and communication between the inside and the outside of the blood vessel is blocked. Therefore, it is possible to prevent the valve body 62 from being opened and closed in response to the attachment / detachment of an infusion line or an external line such as a syringe to the indwelling needle 16 so that the valve body 62 once opened cannot be closed.
  • the pusher 112 Since the pusher 112 has a structure in which two parts of the pusher body 114 and the opening / closing member 116 are combined, the performance required for the base end portion of the pusher 112 and the tip portion of the pusher 112 are required. Performance can be achieved to a high degree. For example, if the pusher 112 according to the present embodiment is adopted, the pusher main body 114 constituting the base end portion of the pusher 112 secures the internal space required for accommodating the needle tip protector 66, and the pusher. The opening / closing member 116 constituting the tip portion of the 112 can stably realize the opening operation of the slit 64 of the valve body 62.
  • the holding mechanism is configured by locking the locking pieces 86, 86 in which the needle tip protection portions 72a, 72b project from the side wall portions 84, 84 and the side edge portions of the elastic plate portion 74b.
  • the position where the holding mechanism is provided is not particularly limited.
  • the holding mechanism can be configured by engaging the tip of the needle tip protection portion 72b with the folded-back portion 82a of the needle tip protection portion 72a.
  • a holding mechanism can be configured by providing a locking structure between the needle tip protection portions 72a and 72b and the positioning portion 88.
  • the contact portion 60 for shifting the needle tip protector 66 to the needle tip protection state is provided in a stepped shape protruding inward from the action portion 58 of the pusher 54.
  • the pusher 54 is provided. It may be a ridge that further protrudes from the input portion 56 of the above to the inner circumference.
  • the contact portion 60 does not necessarily have to be provided on the pusher 54.
  • a notch is formed on the base end side of the pusher 54, and the contact portion 60 is placed on the inner peripheral surface of the outer needle hub 36. It can also be provided.
  • a contact portion that protrudes inward in the radial direction may be formed on the inner surface of the lure connecting member, and is separate from the luer connecting member.
  • the contact portion may be realized by assembling the member of the above to the luer connecting member. Further, the contact portion may not be provided.
  • the structure of the needle tip protector 66 is not limited, and needle tip protectors having various known structures may be adopted in combination. can. Further, even when the needle tip protector 66 is not provided or the needle tip protector 66 is not housed in the pusher 54, 102, 112, the pusher 54, 102, 112 of the above embodiment can be adopted.
  • the pusher 112 of the third embodiment has a two-part configuration in which a pusher main body 114 as a base end member and an opening / closing member 116 as a tip end member are combined.
  • the pusher main body may be composed of three or more parts, for example, the working part 58 and the input part 56 of the 114 are made into separate parts.
  • the needle tip protector is housed inside the pusher, but parts other than the needle tip protector may be housed inside the pusher.
  • a coil spring extrapolated to the needle tip protector can be arranged inside the acting portion of the pusher. According to this, for example, when the inner needle is pulled out, the tip portion of the needle tip protector passes through the inner circumference of the coil spring, and the needle tip protection portion of the needle tip protector can be moved to the protected position. Further, if the coil spring is compressed when the pusher is pressed against the valve body, the pusher is moved to the base end side by the elasticity of the coil spring when the force for pushing the pusher is released. Therefore, the valve body can be quickly moved to the closed state.
  • the entire needle tip protector does not necessarily have to be housed inside the pusher.
  • the needle tip protector may be partially housed inside the pusher, for example, the tip portion of the needle tip protector is housed inside the pusher and the base end portion is exposed to the base end rather than the pusher.
  • the working part of the pusher has not only the inner diameter but also the outer diameter larger than the input part.
  • the working part may have an inner diameter larger than the input part and the outer diameter the same as the input part. ..
  • Indwelling needle assembly (first embodiment) 12 Inner needle unit 14 Inner needle 16 Indwelling needle 18 Outer needle 20 Inner needle hub 22 Needle tip 26 Locking protrusion 28 Hub body 30 Inner needle holding part 32 Taper-shaped part 34 Cap member 35 Breathable filter 36 Outer needle hub 38 Needle fixation Member 40 Lure connecting member 42 Taper part 44 Engagement hole 46 Step 48 Hub connecting part 50 Lure insertion part 52 Engagement claw 54 Pusher 55 Protector accommodating part 56 Input part (small cylinder part) 58 Acting part (large cylinder part) 60 Contact part 62 Valve body 64 Slit 66 Needle tip protector 68 First needle insertion part 70 First circular hole 72 Needle tip protection part 74 Elastic plate part 76 First part 78 Second part 80 Second part 80 Third part 82 Folded part 84 Side wall Part 85 Notch 86 Locking piece 88 Positioning part 90 Support part 92 Second needle insertion part 94 Second circular hole 100 Indwelling needle assembly (second embodiment) 102 Pusher 104 Acting part 106 Insertion protruding part

Abstract

Provided is an indwelling needle assembly having a novel structure that can solve at least one of inherent problems of indwelling needle assemblies having the conventional structure. This indwelling needle assembly 10 comprises a needle tip protector 66. The needle tip protector 66 has needle tip protection parts 72a, 72b located laterally away from an inner needle 14. The indwelling needle assembly 10 comprises an abutting part 60 that stops at an outer needle hub 20 and abuts on the pair of needle tip protection parts 72a, 72b to displace the needle tip protection parts 72a, 72b in the direction approaching the inner needle 14, and consequently leads the needle tip protection parts 72a, 72b to a protection position at which the needle tip 22 of the inner needle 14 having been drawn is covered, when the inner needle 14 is drawn from an outer needle 18. A pusher 54 that switches a valve body 62 is disposed at a position closer to the base end than the valve body 62 within an outer needle hub 36. At least a part of the needle tip protector 66 is housed inside the pusher 54.

Description

留置針組立体Indwelling needle assembly
 本発明は、輸液や採血、人工透析などの際に血管に穿刺される留置針組立体に関するものである。 The present invention relates to an indwelling needle assembly that is punctured into a blood vessel during infusion, blood sampling, artificial dialysis, or the like.
 従来から、輸液や採血、人工透析などの際に血管に穿刺される留置針組立体が知られている。留置針組立体は、特開2010-088520号公報(特許文献1)に示されているように、内針が外針に引抜き可能に挿通されて、内針の基端側に設けられた内針ハブと、外針の基端側に設けられた外針ハブとが、相互に組み合わされた構造を有している。そして、内針とともに外針を血管へ穿刺した後で内針を外針から引き抜くことにより、外針と外針ハブとを有する留置針が血管に穿刺された状態で留置される。 Conventionally, an indwelling needle assembly that is punctured into a blood vessel during infusion, blood sampling, artificial dialysis, etc. has been known. As shown in Japanese Patent Application Laid-Open No. 2010-08520 (Patent Document 1), the indwelling needle assembly is provided on the base end side of the inner needle by inserting the inner needle into the outer needle so as to be retractable. The needle hub and the outer needle hub provided on the base end side of the outer needle have a structure in which they are combined with each other. Then, by puncturing the blood vessel together with the inner needle and then pulling out the inner needle from the outer needle, the indwelling needle having the outer needle and the outer needle hub is indwelled in the state of being punctured in the blood vessel.
 ところで、特許文献1では、外針から引き抜かれた内針が誤って再穿刺されないように、内針の針先を保護する針先プロテクタを備える留置針組立体が提案されている。即ち、特許文献1は、外針ハブの内周に配されたプロテクタ本体が、内針の外針からの引抜きによって内針の先端へ移動して、内針の針先を保護する構造とされている。特許文献1では、内針が外針に挿通された状態において、プロテクタ本体が内針に対して離れており、内針の引抜きに際して内針とプロテクタ本体の摩擦による抵抗力が作用しないようになっている。そして、プロテクタ本体が内針とともに基端側へ移動することにより、外針ハブの内周面に取り付けられた作用リングがプロテクタ本体の先端側へ移動し、作用リングがプロテクタ本体の先端部分を変形させて内針の先端側を覆う位置まで移動させる。これにより、内針の針先がプロテクタ本体によって覆われて保護されるようになっている。 By the way, Patent Document 1 proposes an indwelling needle assembly provided with a needle tip protector that protects the needle tip of the inner needle so that the inner needle pulled out from the outer needle is not accidentally re-punctured. That is, Patent Document 1 has a structure in which the protector body arranged on the inner circumference of the outer needle hub moves to the tip of the inner needle by pulling out the inner needle from the outer needle to protect the needle tip of the inner needle. ing. In Patent Document 1, when the inner needle is inserted into the outer needle, the protector main body is separated from the inner needle, and when the inner needle is pulled out, the resistance force due to the friction between the inner needle and the protector main body does not act. ing. Then, when the protector body moves to the base end side together with the inner needle, the action ring attached to the inner peripheral surface of the outer needle hub moves to the tip end side of the protector body, and the action ring deforms the tip portion of the protector body. Move it to a position that covers the tip side of the inner needle. As a result, the needle tip of the inner needle is covered and protected by the protector body.
特開2010-088520号公報Japanese Unexamined Patent Publication No. 2010-08520
 しかしながら、特許文献1では、プロテクタ本体が内針の針先を保護する状態に保持されるために、プロテクタ本体が作用リングによって変形させられる必要があることから、外針ハブから分離可能な別体の作用リングを設ける必要があった。 However, in Patent Document 1, since the protector main body is held in a state of protecting the needle tip of the inner needle, the protector main body needs to be deformed by the action ring, so that it is a separate body that can be separated from the outer needle hub. It was necessary to provide an action ring.
 また、特開2007-136246号公報に示されているように、弁体を備えた留置針組立体も提案されている。弁体のスリットを先細形状の押し子の先端を弁体のスリットへ差し入れることにより、スリットを開くようになっている。しかし、このような構造の留置針組立体では、押し子がスリットへ挿入可能な直径とされるために、押し子の内部空間が狭くなり易く、押し子の内部に収容される針先プロテクタ等の寸法や形状が制限される場合もあった。 Further, as shown in Japanese Patent Application Laid-Open No. 2007-136246, an indwelling needle assembly provided with a valve body has also been proposed. The slit of the valve body is opened by inserting the tip of the tapered pusher into the slit of the valve body. However, in the indwelling needle assembly having such a structure, since the pusher has a diameter that can be inserted into the slit, the internal space of the pusher tends to be narrowed, and the needle tip protector or the like housed inside the pusher or the like. In some cases, the size and shape of the
 本発明の解決課題は、上述の如き従来構造の留置針組立体に内在する課題の少なくとも一つを解決することができる、新規な構造の留置針組立体を提供することにある。 The problem to be solved by the present invention is to provide an indwelling needle assembly having a novel structure capable of solving at least one of the problems inherent in the indwelling needle assembly having the conventional structure as described above.
 以下、本発明を把握するための好ましい態様について記載するが、以下に記載の各態様は、例示的に記載したものであって、適宜に互いに組み合わせて採用され得るだけでなく、各態様に記載の複数の構成要素についても、可能な限り独立して認識及び採用することができ、適宜に別の態様に記載の何れかの構成要素と組み合わせて採用することもできる。それによって、本発明では、以下に記載の態様に限定されることなく、種々の別態様が実現され得る。 Hereinafter, preferred embodiments for grasping the present invention will be described, but each of the embodiments described below is described as an example, and not only can be appropriately combined with each other and adopted, but also described in each embodiment. The plurality of components of the above can be recognized and adopted independently as much as possible, and can be appropriately adopted in combination with any of the components described in another embodiment. Thereby, in the present invention, various other embodiments can be realized without being limited to the embodiments described below.
 第1の態様は、基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されていると共に、該外針から引き抜かれた該内針の針先を保護する針先プロテクタを備えた留置針組立体であって、前記針先プロテクタは前記内針から側方へ離れて位置する針先保護部を有しており、該内針の前記外針からの引抜きに際して前記外針ハブに止まって該針先保護部に当接して、該針先保護部を該内針への接近側へ変位させることで引き抜かれた該内針の針先を覆う保護位置へ導く当接部を備えていると共に、該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配されており、該針先プロテクタの少なくとも一部が該押し子の内部に収容されているものである。 In the first aspect, the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be pullable, and the inner needle is pulled out from the outer needle. An indwelling needle assembly provided with a needle tip protector that protects the needle tip of the needle, wherein the needle tip protector has a needle tip protector located laterally away from the inner needle, and the inner needle. When the needle is pulled out from the outer needle, the inner needle is pulled out by stopping at the outer needle hub, contacting the needle tip protection portion, and displacing the needle tip protection portion toward the inner needle. It is provided with a contact portion that leads to a protective position that covers the needle tip, and a pusher that switches the valve body is arranged inside the outer needle hub on the proximal end side of the valve body, and at least the needle tip protector is provided. A part of it is housed inside the pusher.
 本態様に従う構造とされた留置針組立体によれば、内針を外針から引き抜く際に、針先プロテクタの針先保護部が当接部によって内針に接近する方向へ変形及び変位させられて、内針の針先が針先保護部で覆われて保護される。 According to the indwelling needle assembly having a structure according to this aspect, when the inner needle is pulled out from the outer needle, the needle tip protection portion of the needle tip protector is deformed and displaced in the direction approaching the inner needle by the contact portion. The needle tip of the inner needle is covered and protected by the needle tip protection portion.
 第2の態様は、基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されており、該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配された留置針組立体であって、前記外針から引き抜かれた前記内針の針先を保護する針先プロテクタの少なくとも一部が前記押し子の内部に収容されて、該押し子は小筒部と大筒部を備えており、該大筒部は該小筒部より先端側に形成され、該大筒部は該小筒部よりも内法寸法が大きくされているものである。 In the second aspect, the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub. The pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and at least a part of the needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle is the pusher. The pusher is provided with a small cylinder portion and a large cylinder portion, the large cylinder portion is formed on the tip side of the small cylinder portion, and the large cylinder portion has an internal dimension larger than that of the small cylinder portion. Is made larger.
 本態様に従う構造とされた留置針組立体によれば、押し子の大筒部の内部に大きな空間が確保され、大筒部の内部に収容される針先プロテクタ等の寸法や形状が制限され難い。 According to the indwelling needle assembly having a structure according to this aspect, a large space is secured inside the large cylinder portion of the pusher, and the size and shape of the needle tip protector and the like housed inside the large cylinder portion are not easily restricted.
 第3の態様は、基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されており、該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配された留置針組立体であって、前記外針から引き抜かれた前記内針の針先を保護する針先プロテクタの少なくとも一部が前記押し子の内部に収容されて、該押し子は、該押し子を前記弁体へ押し付ける外力が入力される入力部と、該入力部よりも先端側に設けられて該弁体を押し開く作用部とを備えており、該作用部が該入力部よりも大径とされているものである。 In the third aspect, the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub. The pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and at least a part of the needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle is the pusher. The pusher is housed in an input portion to which an external force for pressing the pusher against the valve body is input, and an action portion provided on the tip side of the input portion to push the valve body open. The working part has a larger diameter than the input part.
 本態様に従う構造とされた留置針組立体によれば、作用部よりも小径の入力部が基端側に設けられることにより、例えば、外針ハブに基端開口から挿入されて接続される雄ルアーが押し子の基端面に押し当てられて、押し子を弁体に押し付ける外力が押し子に対して有効に入力される。また、作用部によって弁体の外周側を押圧した際に、弁体から押し子に対して基端側への力が作用しやすく、押し子を弁体に押し付ける外力が解除される際に、押し子が初期位置に戻りやすくなる。 According to the indwelling needle assembly having a structure according to this embodiment, an input portion having a diameter smaller than that of the acting portion is provided on the proximal end side, so that, for example, a male is inserted and connected to an outer needle hub from the proximal end opening. The luer is pressed against the base end surface of the pusher, and the external force that pushes the pusher against the valve body is effectively input to the pusher. Further, when the outer peripheral side of the valve body is pressed by the acting portion, a force from the valve body to the base end side is likely to be applied to the pusher, and when the external force for pressing the pusher against the valve body is released, the force is released. It becomes easier for the pusher to return to the initial position.
 第4の態様は、第3の態様に記載された留置針組立体において、前記入力部が前記外針ハブの基端側のルアー挿入部に収容されており、前記作用部の外径寸法が該ルアー挿入部の内径寸法よりも大きくされているものである。 In the fourth aspect, in the indwelling needle assembly according to the third aspect, the input portion is housed in the luer insertion portion on the proximal end side of the outer needle hub, and the outer diameter dimension of the working portion is large. It is made larger than the inner diameter of the lure insertion portion.
 本態様に従う構造とされた留置針組立体によれば、ルアー挿入部の先端と作用部の基端の係止によって、押し子の基端へ向けた移動が制限される。それゆえ、例えば針先プロテクタが押し子に対して摺接しながら基端へ引き抜かれる際に、押し子が針先プロテクタとともに外針ハブから引き抜かれてしまうのを防ぐことができる。 According to the indwelling needle assembly having a structure according to this aspect, the movement toward the base end of the pusher is restricted by the locking of the tip of the luer insertion part and the base end of the action part. Therefore, for example, when the needle tip protector is pulled out to the base end while sliding against the pusher, it is possible to prevent the pusher from being pulled out from the outer needle hub together with the needle tip protector.
 第5の態様は、基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されており、該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配された留置針組立体であって、前記外針から引き抜かれた前記内針の針先を保護する針先プロテクタの少なくとも一部が前記押し子の内部に収容されて、該押し子は、該押し子を前記弁体へ押し付ける外力が入力される入力部と、該入力部よりも先端側に設けられて該弁体を押し開く作用部とを備えており、該入力部よりも大径の該作用部は、外法寸法が前記外針ハブの基端部分の内法寸法よりも大きくされているものである。 In the fifth aspect, the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub. The pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and at least a part of the needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle is the pusher. The pusher is housed in an input portion to which an external force for pressing the pusher against the valve body is input, and an action portion provided on the tip side of the input portion to push the valve body open. The working portion having a diameter larger than that of the input portion has an outer dimension larger than the inner dimension of the base end portion of the outer needle hub.
 本態様に従う構造とされた留置針組立体によれば、押し子の先端部分が大径の作用部とされていることにより、作用部の内部に大きな空間が確保され、作用部の内部に収容される針先プロテクタ等の寸法や形状が制限され難い。 According to the indwelling needle assembly having a structure according to this embodiment, since the tip portion of the pusher is a large-diameter working portion, a large space is secured inside the working portion and is accommodated inside the working portion. It is difficult to limit the dimensions and shape of the needle tip protector and the like.
 第6の態様は、第4又は第5の態様に記載された留置針組立体において、前記弁体には、内周部分を前記内針の針軸方向に貫通するスリットが形成されており、前記作用部の外周端が該スリットの外周端よりも外周に位置しているものである。 A sixth aspect is that in the indwelling needle assembly according to the fourth or fifth aspect, the valve body is formed with a slit that penetrates the inner peripheral portion in the needle axis direction of the inner needle. The outer peripheral end of the working portion is located on the outer periphery of the slit.
 本態様に従う構造とされた留置針組立体によれば、作用部が弁体に押し当てられる際に、作用部の全体が弁体のスリットに入り込むのを防ぐことができる。それゆえ、例えば押し子による弁体の開閉作動が繰り返し実行される場合に、押し子が弁体のスリットから抜けなくなって開位置から閉位置へ復帰できなくなる事態を回避できる。 According to the indwelling needle assembly having a structure according to this aspect, when the working part is pressed against the valve body, it is possible to prevent the entire working part from entering the slit of the valve body. Therefore, for example, when the opening and closing operation of the valve body by the pusher is repeatedly executed, it is possible to avoid a situation in which the pusher cannot come out of the slit of the valve body and cannot return from the open position to the closed position.
 第7の態様は、基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されており、該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配された留置針組立体であって、前記外針から引き抜かれた前記内針の針先を保護する針先プロテクタの少なくとも一部が前記押し子の内部に収容されて、該押し子は、基端部材の先端側の開口部に取り付けられた先端部材を含んでおり、該基端部材の先端側の開口部の少なくとも一部が該先端部材によって塞がれているものである。 In the seventh aspect, the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub. The pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and at least a part of the needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle is the pusher. Contained inside the pusher, the pusher comprises a tip member attached to an opening on the distal end side of the proximal member, at least a portion of the distal opening of the proximal member. It is blocked by.
 本態様に従う構造とされた留置針組立体によれば、例えば、押し子の内部空間を基端部材によって確保することができる。また、押し子における針先保護プロテクタの収容領域の先端開口が、先端部材によって少なくとも一部において塞がれていることにより、針先保護プロテクタが先端側へ動いてしまう場合にも、針先保護プロテクタの先端側への移動量が先端部材によって制限されることから、針先保護プロテクタが押し子よりも先端に配された弁体と干渉するのを防ぐことができる。 According to the indwelling needle assembly having a structure according to this aspect, for example, the internal space of the pusher can be secured by the base end member. Further, even when the needle tip protection protector moves to the tip side due to the tip opening of the accommodating area of the needle tip protection protector in the pusher being blocked at least in a part by the tip member, the needle tip protection is performed. Since the amount of movement of the protector to the tip side is limited by the tip member, it is possible to prevent the needle tip protection protector from interfering with the valve body arranged at the tip rather than the pusher.
 第8の態様は、第7の態様において、前記先端部材が前記基端部材の前記先端開口よりも小径の挿入部を備えているものである。本態様に従う構造とされた留置針組立体によれば、弁体に押し子を押し当てて弁体のスリットを押し開く際に、小径の挿入部が弁体のスリットへ挿入され易く、挿入部が挿入されることによってスリットが開き易くなって、弁体の開作動の安定化が図られる。 In the eighth aspect, in the seventh aspect, the tip member includes an insertion portion having a diameter smaller than that of the tip opening of the base end member. According to the indwelling needle assembly having a structure according to this embodiment, when the pusher is pressed against the valve body to push open the slit of the valve body, the small diameter insertion portion is easily inserted into the slit of the valve body, and the insertion portion is formed. Is inserted, the slit is easily opened, and the opening operation of the valve body is stabilized.
 第9の態様は、基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されており、該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配された留置針組立体であって、前記押し子の先端の開口部分が扁平の筒状とされており、該押し子には、扁平方向の両側において先端へ向けて突出し、前記弁体に形成されたスリットへ挿し入れ可能な挿入突出部が形成されているものである。 In the ninth aspect, the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub. The pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and the opening portion at the tip of the pusher has a flat tubular shape, and the pusher has a flat direction. Insertion protrusions that project toward the tips on both sides and can be inserted into the slits formed in the valve body are formed.
 本態様に従う構造とされた留置針組立体によれば、押し子の挿入突出部が弁体のスリットへ挿入されることによって、スリットが有効に広げられて、弁体の安定した開作動が実現される。また、押し子における扁平方向と直交する大径部分は、弁体のスリットに挿入されないことから、例えば、押し子による弁体の開閉作動が繰り返し実行される場合に、挿入突出部がスリットへ挿入された開位置から初期の閉位置へ復帰し易くなる。特に、押し子の扁平方向と直交する大径部分は、スリットへ挿入されずに、弁体の外周部分に押し当てられることから、弁体の弾性的な復元力が押し子を閉位置へ移動させる方向に作用し、押し子の開位置から閉位置への移動がより安定して実現される。 According to the indwelling needle assembly having a structure according to this aspect, the slit is effectively widened by inserting the insertion protrusion of the pusher into the slit of the valve body, and the stable opening operation of the valve body is realized. Will be done. Further, since the large diameter portion of the pusher orthogonal to the flat direction is not inserted into the slit of the valve body, for example, when the valve body is repeatedly opened and closed by the pusher, the insertion protrusion is inserted into the slit. It becomes easy to return from the opened position to the initial closed position. In particular, the large-diameter portion orthogonal to the flattening direction of the pusher is pressed against the outer peripheral portion of the valve body without being inserted into the slit, so that the elastic restoring force of the valve body moves the pusher to the closed position. It acts in the direction of making the pusher move from the open position to the closed position of the pusher more stably.
 第10の態様は、基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されており、該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配された留置針組立体であって、前記外針から引き抜かれた前記内針の針先を保護する針先プロテクタを備えており、前記押し子の先端の開口部分が扁平の筒状とされていると共に、扁平の筒状とされた該押し子の内部には該針先プロテクタの少なくとも一部を収容するプロテクタ収容部が設けられているものである。 In the tenth aspect, the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side so as to be retractable, and the valve body is inserted inside the outer needle hub. The pusher to be switched is an indwelling needle assembly arranged on the proximal end side of the valve body, and is provided with a needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle. The opening portion at the tip of the needle has a flat tubular shape, and a protector accommodating portion for accommodating at least a part of the needle tip protector is provided inside the pusher having a flat tubular shape. Is.
 本態様に従う構造とされた留置針組立体によれば、針先プロテクタを収容した際の押し子内の無駄な空間を特に扁平方向において削減することができて、針先プロテクタの寸法等を制限することなく、押し子や外針ハブの小型化を図ることができる。なお、扁平の筒状とは、軸直角方向の断面形状における外法寸法が、直交2方向において相互に異なる筒状を言う。 According to the indwelling needle assembly having a structure according to this aspect, the wasted space in the pusher when the needle tip protector is housed can be reduced especially in the flat direction, and the dimensions of the needle tip protector are limited. It is possible to reduce the size of the pusher and the outer needle hub without doing so. The flat tubular shape means a cylindrical shape in which the external dimensions in the cross-sectional shape in the direction perpendicular to the axis are different from each other in the two orthogonal directions.
 第11の態様は、第10の態様に記載の留置針組立体であって、該押し子には、扁平方向の両側において先端へ向けて突出し、前記弁体に形成されたスリットへ挿し入れ可能な挿入突出部が設けられているものである。 The eleventh aspect is the indwelling needle assembly according to the tenth aspect, and the pusher can be inserted into a slit formed in the valve body so as to project toward the tip on both sides in the flat direction. The insertion protrusion is provided.
 本態様に従う構造とされた留置針組立体によれば、押し子の挿入突出部が弁体のスリットへ挿入されることによって、弁体の安定した開作動が実現される。 According to the indwelling needle assembly having a structure according to this aspect, a stable opening operation of the valve body is realized by inserting the insertion protrusion of the pusher into the slit of the valve body.
 本発明によれば、上述の如き従来構造の留置針組立体に内在する課題の少なくとも一つを解決することができる。 According to the present invention, it is possible to solve at least one of the problems inherent in the indwelling needle assembly having the conventional structure as described above.
本発明の第1実施形態としての留置針組立体を示す右側面図Right side view showing the indwelling needle assembly as the first embodiment of the present invention. 図1に示す留置針組立体の断面図であって、図3のII-II断面に相当する図It is a cross-sectional view of the indwelling needle assembly shown in FIG. 1, and corresponds to the II-II cross section of FIG. 図2のIII-III断面図Section III-III sectional view of FIG. 図3の留置針組立体を構成する内針の先端部分を示す断面図FIG. 3 is a cross-sectional view showing a tip portion of an inner needle constituting the indwelling needle assembly of FIG. 図1の留置針組立体を構成する針先プロテクタを拡大して示す斜視図An enlarged perspective view of the needle tip protector constituting the indwelling needle assembly of FIG. 1. 図5の針先プロテクタを別の角度で示す斜視図A perspective view showing the needle tip protector of FIG. 5 at another angle. 図5に示す針先プロテクタの右側面図Right side view of the needle tip protector shown in FIG. 図7に示す針先プロテクタの底面図Bottom view of the needle tip protector shown in FIG. 図8のIX-IX断面図IX-IX sectional view of FIG. 図1の留置針組立体の一部を示す断面図であって、内針の引抜き途中を示す図It is sectional drawing which shows the part of the indwelling needle assembly of FIG. 図1の留置針組立体の一部を示す断面図であって、内針の引抜き途中で針先が針先プロテクタによって保護された状態を示す図FIG. 1 is a cross-sectional view showing a part of the indwelling needle assembly of FIG. 1, showing a state in which the needle tip is protected by a needle tip protector while the inner needle is being pulled out. 図5の針先プロテクタを針先保護状態で示す斜視図A perspective view showing the needle tip protector of FIG. 5 in the needle tip protection state. 図1の留置針組立体の一部を拡大して示す断面図であって、内針ユニットが留置針から分離した状態を示す図FIG. 1 is an enlarged cross-sectional view showing a part of the indwelling needle assembly of FIG. 1, showing a state in which the inner needle unit is separated from the indwelling needle. 本発明の第2実施形態としての留置針組立体の一部を示す断面図であって、図15のXIV-XIV断面に相当する図It is sectional drawing which shows the part of the indwelling needle assembly as 2nd Embodiment of this invention, and corresponds to the XIV-XIV sectional | cross section of FIG. 図14のXV-XV断面図FIG. 14 is a cross-sectional view taken along the line XV-XV. 図14の留置針組立体を構成する押し子の斜視図A perspective view of a pusher constituting the indwelling needle assembly of FIG. 図16の押し子を別の角度で示す斜視図A perspective view showing the pusher of FIG. 16 at another angle. 図16に示す押し子の正面図Front view of pusher shown in FIG. 本発明の第3実施形態としての留置針組立体の一部を示す断面図Sectional drawing which shows a part of the indwelling needle assembly as the 3rd Embodiment of this invention. 図19の留置針組立体を構成する押し子の斜視図A perspective view of a pusher constituting the indwelling needle assembly of FIG.
 以下、本発明の実施形態について、図面を参照しつつ説明する。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.
 図1~図3には、本発明の第1実施形態としての留置針組立体10が示されている。留置針組立体10は、内針ユニット12を構成する内針14が、留置針16を構成する外針18に挿通されて、内針ユニット12と留置針16が組み合わされた構造を有している。以下の説明において、原則として、上下方向とは図1中の上下方向を、左右方向とは図3中の上下方向を、それぞれ言う。また、先端側とは遠位となる図1中の左方を、基端側とは近位となる図1中の右方を、それぞれ言う。 1 to 3 show an indwelling needle assembly 10 as a first embodiment of the present invention. The indwelling needle assembly 10 has a structure in which the inner needle 14 constituting the inner needle unit 12 is inserted into the outer needle 18 constituting the indwelling needle 16 and the inner needle unit 12 and the indwelling needle 16 are combined. There is. In the following description, as a general rule, the vertical direction refers to the vertical direction in FIG. 1, and the horizontal direction refers to the vertical direction in FIG. 3. Further, the left side in FIG. 1, which is distal to the distal end side, and the right side in FIG. 1, which is proximal to the proximal end side, are referred to.
 内針ユニット12は、内針14に内針ハブ20が固定された構造を備えている。内針14は、金属等によって形成された硬質の部材であって、本実施形態では中空針とされている。内針14の先端は、先端面が傾斜形状に切削されており、鋭利な針先22が形成されている。内針14の先端部分には、図4に示すように、内腔を遮断する閉塞部24が設けられている。内針14の先端部分には、外周面に突出する一対の係止突起26,26が形成されている。係止突起26は、左右方向(図3,図4中の上下方向)に突出しており、例えば内針14を部分的に上下方向で潰すことによって形成される。本実施形態では、係止突起26が内針14の閉塞部24に設けられているが、係止突起26は閉塞部24を外れた内針14の中空部分に設けられていてもよい。また、内針14は閉塞部24を備えていなくてもよく、例えば内針14の内腔が先端から基端まで貫通して形成されていてもよい。 The inner needle unit 12 has a structure in which the inner needle hub 20 is fixed to the inner needle 14. The inner needle 14 is a hard member made of metal or the like, and is a hollow needle in the present embodiment. The tip surface of the inner needle 14 is cut into an inclined shape, and a sharp needle tip 22 is formed. As shown in FIG. 4, the tip portion of the inner needle 14 is provided with a closing portion 24 for blocking the lumen. A pair of locking protrusions 26, 26 protruding from the outer peripheral surface are formed at the tip portion of the inner needle 14. The locking projection 26 projects in the left-right direction (vertical direction in FIGS. 3 and 4), and is formed by, for example, partially crushing the inner needle 14 in the vertical direction. In the present embodiment, the locking projection 26 is provided in the closing portion 24 of the inner needle 14, but the locking projection 26 may be provided in the hollow portion of the inner needle 14 that is out of the closing portion 24. Further, the inner needle 14 does not have to be provided with the closing portion 24, and for example, the lumen of the inner needle 14 may be formed so as to penetrate from the tip end to the base end.
 内針ハブ20は、図1~図3に示すように、ハブ本体28を備えている。ハブ本体28は、先端部分が略矩形筒形状とされ、基端部分が略円筒形状とされている。ハブ本体28の先端部分は、外周面が軸方向に湾曲して軸方向の両端から中央に向けて小径となっており、手指で摘まんで軸方向に移動操作する際に指が滑り難くなっている。ハブ本体28は、先端部分の内周面から突出して基端へ向けて延びる略円筒状の内針保持部30を一体的に備えている。内針保持部30の内周面が内針14の外周面に対して接着されており、ハブ本体28が内針14に固定されている。ハブ本体28の先端には、外周へ向けて突出する鍔状部32が設けられて、ハブ本体28の先端面が後述する外針ハブ36の基端面よりも内径が小さく且つ外径が大きくされている。 The inner needle hub 20 includes a hub main body 28 as shown in FIGS. 1 to 3. The hub body 28 has a substantially rectangular tubular shape at the tip end portion and a substantially cylindrical shape at the base end portion. The outer peripheral surface of the tip portion of the hub body 28 is curved in the axial direction and has a small diameter from both ends in the axial direction toward the center, so that the fingers do not slip easily when being picked up by fingers and moved in the axial direction. There is. The hub main body 28 integrally includes a substantially cylindrical inner needle holding portion 30 that protrudes from the inner peripheral surface of the tip portion and extends toward the base end. The inner peripheral surface of the inner needle holding portion 30 is adhered to the outer peripheral surface of the inner needle 14, and the hub main body 28 is fixed to the inner needle 14. The tip of the hub body 28 is provided with a flange-shaped portion 32 projecting toward the outer periphery, so that the tip surface of the hub body 28 has an inner diameter smaller and an outer diameter larger than the base end surface of the outer needle hub 36 described later. ing.
 ハブ本体28の基端開口部分には、キャップ部材34が取り付けられている。キャップ部材34は、全体として略円筒形状とされている。キャップ部材34は、小径の先端部分が先端に向けて縮径するテーパ状の外周面を有しており、当該先端部分がハブ本体28の基端開口部分に嵌合されることによって、ハブ本体28に取り付けられている。キャップ部材34の基端開口部分には、通気性フィルタ35が取り付けられており、キャップ部材34の内部の空気が通気性フィルタ35を通じて外部へ排出可能である一方、例えば穿刺時のフラッシュバックによって内針14を通じてキャップ部材34の内部に入った血液は、通気性フィルタ35を通過せず、キャップ部材34の内部から漏出しない。なお、キャップ部材34は、内針14の血管への穿刺時のフラッシュバックを視認し易くするために、透明又は半透明であることが望ましい。 A cap member 34 is attached to the base end opening portion of the hub main body 28. The cap member 34 has a substantially cylindrical shape as a whole. The cap member 34 has a tapered outer peripheral surface in which the tip portion having a small diameter is reduced in diameter toward the tip, and the tip portion is fitted to the base end opening portion of the hub body 28 to fit the hub body. It is attached to 28. A breathable filter 35 is attached to the base end opening portion of the cap member 34, and the air inside the cap member 34 can be discharged to the outside through the breathable filter 35, while being inside by, for example, flashback at the time of puncture. Blood that has entered the inside of the cap member 34 through the needle 14 does not pass through the breathable filter 35 and does not leak from the inside of the cap member 34. The cap member 34 is preferably transparent or translucent so that the flashback at the time of puncturing the blood vessel of the inner needle 14 can be easily visually recognized.
 留置針16は、外針18の基端に外針ハブ36が設けられた構造を有している。外針18は、樹脂や金属によって形成された中空針とされている。外針18は、先端部分の外周面が先端へ向けて小径となるテーパ面とされていることが望ましい。 The indwelling needle 16 has a structure in which the outer needle hub 36 is provided at the base end of the outer needle 18. The outer needle 18 is a hollow needle made of resin or metal. It is desirable that the outer needle 18 has a tapered surface whose outer peripheral surface of the tip portion has a smaller diameter toward the tip.
 外針18の基端部は、筒状とされた外針ハブ36の内周へ挿入されて、外針ハブ36に固定されている。外針ハブ36は、例えば樹脂製の筒状体とされている。本実施形態の外針ハブ36は、先端部分を構成する針固着部材38と、基端部分を構成するルアー連結部材40とが、組み合わされた構造を有している。もっとも、外針ハブ36は、全体が1つの部品で構成されていてもよいし、3つ以上の部品を組み合わせて構成されていてもよい。また、複数の部品を組み合わせて外針ハブ36を構成する場合に、それら部品は非接着で嵌合される等して固定されていてもよいし、接着や溶着などの手段で固着されていてもよい。 The base end portion of the outer needle 18 is inserted into the inner circumference of the tubular outer needle hub 36 and fixed to the outer needle hub 36. The outer needle hub 36 is, for example, a resin tubular body. The outer needle hub 36 of the present embodiment has a structure in which a needle fixing member 38 constituting a tip portion and a luer connecting member 40 constituting a base end portion are combined. However, the outer needle hub 36 may be entirely composed of one component, or may be configured by combining three or more components. Further, when a plurality of parts are combined to form the outer needle hub 36, these parts may be fixed by being fitted by being non-adhesive, or may be fixed by means such as adhesion or welding. May be good.
 針固着部材38は、全体として円筒状とされて、軸方向の途中に基端へ向けて大径となるテーパ部42を備えており、テーパ部42よりも基端側が先端側よりも大径とされている。針固着部材38には、上下方向に貫通する係合孔44,44が形成されており、係合孔44よりも基端側が基端へ向けて拡開するテーパ形状の内周面を備えている。そして、小径とされた針固着部材38の先端部分に外針18が挿入されて、外針18が筒状のピンによって針固着部材38に固定されている。 The needle fixing member 38 has a cylindrical shape as a whole, and has a tapered portion 42 having a large diameter toward the proximal end in the middle of the axial direction, and the proximal end side of the tapered portion 42 has a larger diameter than the tip end side. It is said that. The needle fixing member 38 is formed with engaging holes 44, 44 penetrating in the vertical direction, and is provided with a tapered inner peripheral surface whose proximal end side expands toward the proximal end with respect to the engaging hole 44. There is. Then, the outer needle 18 is inserted into the tip portion of the needle fixing member 38 having a small diameter, and the outer needle 18 is fixed to the needle fixing member 38 by a cylindrical pin.
 ルアー連結部材40は、全体として円筒状であって、軸方向の途中に段差46が設けられており、段差46よりも先端側が大径のハブ連結部48とされていると共に、基端側が小径のルアー挿入部50とされている。ハブ連結部48の外周面には、一対の係合爪52が設けられており、それら係合爪52が針固着部材38に設けられた係合孔44の内面に係合されることによって、針固着部材38とルアー連結部材40が連結されて外針ハブ36を構成している。ルアー挿入部50の内周面は、基端へ向けて拡径するルアーテーパーとされている。 The luer connecting member 40 is cylindrical as a whole, and a step 46 is provided in the middle in the axial direction, and the tip side of the step 46 is a hub connecting portion 48 having a large diameter, and the base end side has a small diameter. It is said to be the lure insertion portion 50 of the above. A pair of engaging claws 52 are provided on the outer peripheral surface of the hub connecting portion 48, and the engaging claws 52 are engaged with the inner surface of the engaging hole 44 provided in the needle fixing member 38. The needle fixing member 38 and the luer connecting member 40 are connected to form the outer needle hub 36. The inner peripheral surface of the luer insertion portion 50 has a luer taper that expands in diameter toward the base end.
 外針ハブ36のルアー連結部材40には、押し子54が収容されている。押し子54は、全体として略段付き円筒形状とされており、軸方向に貫通するプロテクタ収容部55を内部に備えている。押し子54は、基端部分が小径の小筒部である入力部56とされ、先端部分が入力部56よりも大径の大筒部である作用部58とされている。入力部56と作用部58は、外針ハブ36の内部に位置する作用部58の基端において外針ハブ36及び押し子54の内周へ向けて突出する段差状の当接部60によって、一体的に連続して設けられている。押し子54の内周面形状は、入力部56において後述する針先プロテクタ66の第1針挿通部68に対応する四角形とされていると共に、作用部58において円形とされている。これにより、当接部60の作用部58からの突出寸法は、周方向において変化している。作用部58の軸直角方向の内法寸法は、入力部56の軸直角方向の内法寸法よりも大きくされている。従って、押し子54の内周に設けられたプロテクタ収容部55は、先端部分が基端部分よりも大径とされている。なお、入力部56の内周面形状は、四角形に限定されるものではないが、好適には、針先プロテクタ66の回転を阻止し得るように、楕円形や多角形など内径寸法が周方向で変化した形状とされる。押し子54には、周壁を貫通するスリット(孔)などを適宜に設けてもよい。 The pusher 54 is housed in the luer connecting member 40 of the outer needle hub 36. The pusher 54 has a substantially stepped cylindrical shape as a whole, and has a protector accommodating portion 55 penetrating in the axial direction inside. The pusher 54 has an input portion 56 whose base end portion is a small cylinder portion having a small diameter, and an action portion 58 whose tip portion is a large cylinder portion having a larger diameter than the input portion 56. The input portion 56 and the action portion 58 are formed by a stepped contact portion 60 that protrudes toward the inner circumference of the outer needle hub 36 and the pusher 54 at the base end of the action portion 58 located inside the outer needle hub 36. It is provided integrally and continuously. The shape of the inner peripheral surface of the pusher 54 is a quadrangle corresponding to the first needle insertion portion 68 of the needle tip protector 66 described later in the input portion 56, and is circular in the action portion 58. As a result, the protruding dimension of the contact portion 60 from the acting portion 58 changes in the circumferential direction. The internal dimension of the working portion 58 in the direction perpendicular to the axis is larger than the internal dimension of the input portion 56 in the direction perpendicular to the axis. Therefore, the protector accommodating portion 55 provided on the inner circumference of the pusher 54 has a tip portion having a larger diameter than the base end portion. The shape of the inner peripheral surface of the input unit 56 is not limited to a quadrangle, but preferably, the inner diameter dimension such as an ellipse or a polygon is in the circumferential direction so as to prevent the needle tip protector 66 from rotating. It is said that the shape has changed with. The pusher 54 may be appropriately provided with a slit (hole) or the like that penetrates the peripheral wall.
 押し子54は、入力部56がルアー連結部材40のルアー挿入部50に収容され、作用部58がルアー連結部材40のハブ連結部48に収容されている。押し子54の入力部56は、略一定の外径寸法で延びており、ルアーテーパーを有するルアー挿入部50の内周面と入力部56の外周面との間に隙間が形成されている。押し子54は、作用部58の外周面が外針ハブ36のハブ連結部48の内周面に重ね合わされることにより、外針ハブ36に対して軸直角方向で位置決めされている。また、押し子54は、作用部58の外法寸法が外針ハブ36の基端部を構成するルアー挿入部50の内法寸法よりも大きくされており、作用部58の基端面が外針ハブ36の段差46に重ね合わされることにより、外針ハブ36に対して軸方向で位置決めされている。押し子54の基端は、外針ハブ36(ルアー連結部材40)の基端よりも先端側に位置しており、押し子54が外針ハブ36から基端へ突出することなく収容されている。 In the pusher 54, the input portion 56 is housed in the luer insertion part 50 of the luer connecting member 40, and the working part 58 is housed in the hub connecting part 48 of the luer connecting member 40. The input portion 56 of the pusher 54 extends with a substantially constant outer diameter, and a gap is formed between the inner peripheral surface of the luer insertion portion 50 having a luer taper and the outer peripheral surface of the input portion 56. The pusher 54 is positioned in a direction perpendicular to the axis of the outer needle hub 36 by superimposing the outer peripheral surface of the acting portion 58 on the inner peripheral surface of the hub connecting portion 48 of the outer needle hub 36. Further, in the pusher 54, the outer dimension of the acting portion 58 is larger than the inner dimension of the luer insertion portion 50 constituting the proximal end portion of the outer needle hub 36, and the proximal end surface of the acting portion 58 is the outer needle. By being superposed on the step 46 of the hub 36, it is positioned in the axial direction with respect to the outer needle hub 36. The base end of the pusher 54 is located on the tip side of the base end of the outer needle hub 36 (lure connecting member 40), and the pusher 54 is accommodated without protruding from the outer needle hub 36 to the base end. There is.
 外針ハブ36の内部における押し子54の先端側には、弁体62が配されている。弁体62は、ゴム状弾性を有する樹脂エラストマーやゴムによって形成されている。弁体62は、略円板形状とされており、外周端部が外針ハブ36を構成する針固着部材38とルアー連結部材40との間で厚さ方向に挟持されることによって、外針ハブ36の内腔を塞ぐように配されている。弁体62は、内周部分を貫通するスリット64を備えている。スリット64は、例えば弁体62の中心から放射状に延びており、弁体62を内針14の針軸方向である図2中の左右方向に貫通している。そして、外針ハブ36の内腔は、弁体62のスリット64が開閉されることによって、スリット64を通じた連通状態と、遮断状態とに切り替えられる。 A valve body 62 is arranged on the tip end side of the pusher 54 inside the outer needle hub 36. The valve body 62 is formed of a resin elastomer or rubber having rubber-like elasticity. The valve body 62 has a substantially disk shape, and the outer peripheral end portion is sandwiched between the needle fixing member 38 constituting the outer needle hub 36 and the luer connecting member 40 in the thickness direction to obtain an outer needle. It is arranged so as to block the lumen of the hub 36. The valve body 62 includes a slit 64 that penetrates the inner peripheral portion. The slit 64 extends radially from the center of the valve body 62, for example, and penetrates the valve body 62 in the left-right direction in FIG. 2, which is the needle axis direction of the inner needle 14. Then, the lumen of the outer needle hub 36 is switched between a communication state through the slit 64 and a blocking state by opening and closing the slit 64 of the valve body 62.
 押し子54は弁体62よりも基端側に配されており、押し子54の作用部58の先端外周縁は、弁体62のスリット64の外周端よりも外周側に位置している。これにより、押し子54は、先端面の少なくとも外周端がスリット64よりも外周に位置している。より好適には、作用部58の先端内周縁がスリット64の外周端よりも外周側に位置しており、作用部58の先端面の全体がスリット64を外周に外れて位置している。押し子54の先端は、外針ハブ36に支持された弁体62に対して当接していてもよいが、本実施形態では弁体62に対して基端へ離れて位置している。 The pusher 54 is arranged on the base end side of the valve body 62, and the outer peripheral edge of the tip of the acting portion 58 of the pusher 54 is located on the outer peripheral side of the outer peripheral end of the slit 64 of the valve body 62. As a result, at least the outer peripheral end of the tip surface of the pusher 54 is located on the outer periphery of the slit 64. More preferably, the inner peripheral edge of the tip of the acting portion 58 is located on the outer peripheral side of the outer peripheral end of the slit 64, and the entire tip surface of the acting portion 58 is located off the outer periphery of the slit 64. The tip of the pusher 54 may be in contact with the valve body 62 supported by the outer needle hub 36, but in the present embodiment, the tip is located away from the base end with respect to the valve body 62.
 押し子54の内部に設けられたプロテクタ収容部55には、図5~図9に示されているような針先プロテクタ66が収容されている。針先プロテクタ66の全体が押し子54の内部に位置しており、外針ハブ36の大型化が防止されている。針先プロテクタ66は、例えば、弾性変形可能な金属の板材によって形成されている。針先プロテクタ66は、内針14の針軸方向に対して略直交して広がる第1針挿通部68を基端に備えている。第1針挿通部68は、矩形板状とされており、中央には内針14の外形と対応する第1円形孔70が厚さ方向に貫通して形成されている。第1円形孔70の直径は、係止突起26,26を外れた部位における内針14の外径寸法よりも大きく、且つ係止突起26,26の形成部位における内針14の外径寸法よりも小さくされている。 The protector accommodating portion 55 provided inside the pusher 54 accommodates the needle tip protector 66 as shown in FIGS. 5 to 9. The entire needle tip protector 66 is located inside the pusher 54, preventing the outer needle hub 36 from becoming larger. The needle tip protector 66 is formed of, for example, an elastically deformable metal plate material. The needle tip protector 66 includes a first needle insertion portion 68 extending substantially orthogonal to the needle axis direction of the inner needle 14 at the base end. The first needle insertion portion 68 has a rectangular plate shape, and a first circular hole 70 corresponding to the outer shape of the inner needle 14 is formed in the center so as to penetrate in the thickness direction. The diameter of the first circular hole 70 is larger than the outer diameter of the inner needle 14 at the portion where the locking protrusions 26, 26 are removed, and is larger than the outer diameter dimension of the inner needle 14 at the portion where the locking protrusions 26, 26 are formed. Has also been made smaller.
 針先プロテクタ66は、一対の針先保護部72a,72bを備えている。一対の針先保護部72a,72bは、第1針挿通部68の上下端部から先端へ向けて延び出している。針先保護部72aは、第1針挿通部68の上端部から先端へ向けて延び出す弾性板部74aを備えている。弾性板部74aは、基端部分である第1部位76aが上下方向と直交していると共に、中間部分である第2部位78aが先端へ向けて上傾しており、先端部分である第3部位80aが先端へ向けて下傾している。また、針先保護部72aは、第3部位80aの先端部が基端へ向けて下側へ折り返された折返部82aを備えている。 The needle tip protector 66 includes a pair of needle tip protection portions 72a and 72b. The pair of needle tip protection portions 72a and 72b extend from the upper and lower ends of the first needle insertion portion 68 toward the tip. The needle tip protection portion 72a includes an elastic plate portion 74a extending from the upper end portion of the first needle insertion portion 68 toward the tip end. In the elastic plate portion 74a, the first portion 76a, which is the base end portion, is orthogonal to the vertical direction, and the second portion 78a, which is the intermediate portion, is tilted upward toward the tip, and the third portion is the tip portion. The portion 80a is tilted downward toward the tip. Further, the needle tip protection portion 72a includes a folded portion 82a in which the tip end portion of the third portion 80a is folded downward toward the base end.
 針先保護部72aの先端部分には、一対の側壁部84,84が左右方向で相互に対向して設けられている。側壁部84は、弾性板部74aの第3部位80aから延び出している。側壁部84は、図7に示す側方視において先端に向けて針先保護部72aからの突出寸法が小さくなる先細形状とされている。針先保護部72aの折返部82aと側壁部84との間に切込み85が形成されていることから、側壁部84は、折返部82aによって過度に拘束されることなく、厚さ方向の撓み変形を許容される。針先保護部72aの一対の側壁部84,84には、それぞれ係止片86が一体的に設けられている。係止片86は、側壁部84の突出先端に沿って延びており、一対の側壁部84,84の対向方向の内側へ向けて突出している。係止片86は、図9に示すように、突出先端へ向けて厚さ方向で弾性板部74a側へ傾斜している。 A pair of side wall portions 84, 84 are provided on the tip portion of the needle tip protection portion 72a so as to face each other in the left-right direction. The side wall portion 84 extends from the third portion 80a of the elastic plate portion 74a. The side wall portion 84 has a tapered shape in which the protrusion dimension from the needle tip protection portion 72a becomes smaller toward the tip in the lateral view shown in FIG. 7. Since the notch 85 is formed between the folded-back portion 82a and the side wall portion 84 of the needle tip protection portion 72a, the side wall portion 84 is not excessively restrained by the folded-back portion 82a and is deformed by bending in the thickness direction. Is allowed. A locking piece 86 is integrally provided on each of the pair of side wall portions 84 and 84 of the needle tip protection portion 72a. The locking piece 86 extends along the protruding tip of the side wall portion 84, and protrudes inward in the facing direction of the pair of side wall portions 84, 84. As shown in FIG. 9, the locking piece 86 is inclined toward the elastic plate portion 74a in the thickness direction toward the protruding tip.
 針先保護部72bは、第1針挿通部68の下端部から先端へ向けて延び出す弾性板部74bを備えている。弾性板部74bは、基端部分である第1部位76bが上下方向と直交していると共に、中間部分である第2部位78bが先端へ向けて下傾しており、先端部分である第3部位80bが先端へ向けて上傾している。また、針先保護部72bは、第3部位80bの先端部が基端へ向けて上側へ折り返された折返部82bを備えている。針先保護部72aの折返部82aと針先保護部72bの折返部82bは、針軸方向の投影において、上下方向で相互に離れている。 The needle tip protection portion 72b includes an elastic plate portion 74b extending from the lower end portion of the first needle insertion portion 68 toward the tip end. In the elastic plate portion 74b, the first portion 76b, which is the base end portion, is orthogonal to the vertical direction, and the second portion 78b, which is the intermediate portion, is tilted downward toward the tip, and the third portion is the tip portion. The portion 80b is tilted upward toward the tip. Further, the needle tip protection portion 72b includes a folded portion 82b in which the tip end portion of the third portion 80b is folded upward toward the base end. The folded portion 82a of the needle tip protection portion 72a and the folded portion 82b of the needle tip protection portion 72b are separated from each other in the vertical direction in the projection in the needle axis direction.
 針先保護部72bは、針先保護部72aよりも第1針挿通部68から先端までの長さが短くされている。針先保護部72bの先端は、図8に示すように、針先保護部72aの係止片86まで達していると共に、針先保護部72aの折返部82aまでは達していない。また、針先保護部72bの第3部位80bは、針先保護部72aの第3部位80aよりも左右方向の幅寸法が小さくされている。第3部位80bの幅寸法は、一対の側壁部84,84の対向間距離よりも小さく、且つ一対の係止片86,86間の距離よりも大きくされている。 The length of the needle tip protection portion 72b from the first needle insertion portion 68 to the tip is shorter than that of the needle tip protection portion 72a. As shown in FIG. 8, the tip of the needle tip protection portion 72b reaches the locking piece 86 of the needle tip protection portion 72a and does not reach the folded portion 82a of the needle tip protection portion 72a. Further, the width dimension of the third portion 80b of the needle tip protection portion 72b in the left-right direction is smaller than that of the third portion 80a of the needle tip protection portion 72a. The width dimension of the third portion 80b is smaller than the distance between the pair of side wall portions 84 and 84 and larger than the distance between the pair of locking pieces 86 and 86.
 針先プロテクタ66は、一対の針先保護部72a,72bの対向間に位置決め部88を備えている。位置決め部88は、第1針挿通部68から先端へ向けて延び出す支持部90と、第1針挿通部68に対して先端側において略平行に対向する第2針挿通部92とを備えており、第1針挿通部68と第2針挿通部92が支持部90によって一体的につながれた構造とされている。第2針挿通部92には、第2円形孔94が厚さ方向に貫通して形成されている。第2円形孔94は、第1円形孔70よりも大径とされており、内針14を引き抜く際に、内針14の係止突起26,26が容易に通過可能な直径とされている。 The needle tip protector 66 is provided with a positioning portion 88 between the pair of needle tip protection portions 72a and 72b facing each other. The positioning portion 88 includes a support portion 90 extending from the first needle insertion portion 68 toward the tip, and a second needle insertion portion 92 facing substantially parallel to the first needle insertion portion 68 on the tip side. The structure is such that the first needle insertion portion 68 and the second needle insertion portion 92 are integrally connected by a support portion 90. A second circular hole 94 is formed in the second needle insertion portion 92 so as to penetrate in the thickness direction. The second circular hole 94 has a diameter larger than that of the first circular hole 70, and has a diameter that allows the locking projections 26, 26 of the inner needle 14 to easily pass through when the inner needle 14 is pulled out. ..
 針先プロテクタ66は、図2,図3に示すように、押し子54のプロテクタ収容部55に収容されている。即ち、第1針挿通部68と、一対の針先保護部72a,72bの第1部位76a,76bと、位置決め部88の基端部分とが、押し子54の入力部56の先端部分へ挿入されている。また、一対の針先保護部72a,72bの第2部位78a,78b及び第3部位80a,80bと、第2針挿通部92を含む位置決め部88の先端部分とが、押し子54の作用部58へ挿入されている。針先プロテクタ66の基端部分が四角形の内周断面形状を有して小径とされた入力部56に挿入されていることにより、針先プロテクタ66が押し子54に対して軸直角方向で位置決めされており、がたつきや位置ずれが防止されている。また、針先プロテクタ66の先端部分が内部空間の広い作用部58に収容されていることにより、一対の針先保護部72a,72bが相互に離れた初期形状を保った状態で押し子54に収容されている。 As shown in FIGS. 2 and 3, the needle tip protector 66 is housed in the protector accommodating portion 55 of the pusher 54. That is, the first needle insertion portion 68, the first portions 76a, 76b of the pair of needle tip protection portions 72a, 72b, and the base end portion of the positioning portion 88 are inserted into the tip portion of the input portion 56 of the pusher 54. Has been done. Further, the second portions 78a and 78b and the third portions 80a and 80b of the pair of needle tip protection portions 72a and 72b, and the tip portion of the positioning portion 88 including the second needle insertion portion 92 are the acting portions of the pusher 54. It is inserted in 58. Since the base end portion of the needle tip protector 66 is inserted into the input portion 56 having a quadrangular inner peripheral cross-sectional shape and having a small diameter, the needle tip protector 66 is positioned in the direction perpendicular to the axis with respect to the pusher 54. It is designed to prevent rattling and misalignment. Further, since the tip portion of the needle tip protector 66 is housed in the working portion 58 having a wide internal space, the pair of needle tip protection portions 72a and 72b are held in the pusher 54 in a state where they are separated from each other in the initial shape. It is contained.
 外針ハブ36の内部において押し子54のプロテクタ収容部55に針先プロテクタ66が収容された状態下、一対の針先保護部72a,72bの第2部位78a,78bと、押し子54の当接部60は、針軸方向の投影において重なり合う位置に配置されている。換言すれば、一対の針先保護部72a,72bにおける上下方向の外端(第2部位78と第3部位80の境界部分)は、当接部60における上下方向の内端に対して、上下方向の外側に位置している。 While the needle tip protector 66 is housed in the protector accommodating portion 55 of the pusher 54 inside the outer needle hub 36, the second portions 78a and 78b of the pair of needle tip protection portions 72a and 72b and the pusher 54 are hit. The tangent portion 60 is arranged at an overlapping position in the projection in the needle axis direction. In other words, the vertical outer ends of the pair of needle tip protection portions 72a and 72b (the boundary portion between the second portion 78 and the third portion 80) are up and down with respect to the vertical inner end of the contact portion 60. It is located outside the direction.
 内針ユニット12と留置針16は、相互に組み合わされて留置針組立体10を構成する。即ち、内針14は、留置針16に対して基端側から挿入されて、針先22が外針18の先端開口から突出するように留置針16を貫通する。内針ユニット12の内針ハブ20は、外針ハブ36の基端面に対して軸方向で基端側から突き当てられており、それによって内針14の外針18から先端への突出量が規定される。 The inner needle unit 12 and the indwelling needle 16 are combined with each other to form the indwelling needle assembly 10. That is, the inner needle 14 is inserted into the indwelling needle 16 from the proximal end side, and penetrates the indwelling needle 16 so that the needle tip 22 protrudes from the tip opening of the outer needle 18. The inner needle hub 20 of the inner needle unit 12 is abutted from the base end side in the axial direction with respect to the base end surface of the outer needle hub 36, whereby the amount of protrusion of the inner needle 14 from the outer needle 18 to the tip is increased. It is stipulated.
 内針14は、針先プロテクタ66を貫通している。即ち、留置針16に対して基端側から挿入された内針14は、針先プロテクタ66の第1針挿通部68の第1円形孔70と第2針挿通部92の第2円形孔94に挿通され、一対の針先保護部72a,72bの折返部82a,82bの間を先端側へ貫通する。内針14が第1針挿通部68の第1円形孔70と第2針挿通部92の第2円形孔94に挿通されることにより、針先プロテクタ66が内針14に対する軸直角方向への移動及び傾動を制限されて、針先プロテクタ66に対して位置決めされている。一対の針先保護部72a,72bは、外力の作用していない針先プロテクタ66の初期形状において内針14に対して上下方向で側方に離れており、内針14の針先プロテクタ66に対する軸方向の移動に際して、内針14と一対の針先保護部72a,72b(折返部82a,82b)との接触による摩擦抵抗を生じることなく、内針14がスムーズに移動可能とされている。また、一対の針先保護部72a,72bが初期形状において内針14の上下幅寸法よりも大きな離隔距離で配置されていることから、内針14を針先プロテクタ66に対して基端側から挿通する際に、一対の針先保護部72a,72b間を押し広げる必要がなく、内針14の挿通作業が容易とされる。 The inner needle 14 penetrates the needle tip protector 66. That is, the inner needle 14 inserted from the proximal end side with respect to the indwelling needle 16 has a first circular hole 70 of the first needle insertion portion 68 of the needle tip protector 66 and a second circular hole 94 of the second needle insertion portion 92. And penetrates between the folded portions 82a and 82b of the pair of needle tip protection portions 72a and 72b toward the tip side. By inserting the inner needle 14 into the first circular hole 70 of the first needle insertion portion 68 and the second circular hole 94 of the second needle insertion portion 92, the needle tip protector 66 moves in the direction perpendicular to the axis of the inner needle 14. It is positioned with respect to the needle tip protector 66 with limited movement and tilt. The pair of needle tip protection portions 72a and 72b are separated from the inner needle 14 in the vertical direction in the initial shape of the needle tip protector 66 on which no external force is applied, and are separated from the needle tip protector 66 of the inner needle 14 in the vertical direction. When moving in the axial direction, the inner needle 14 can move smoothly without causing frictional resistance due to contact between the inner needle 14 and the pair of needle tip protection portions 72a, 72b (folded portions 82a, 82b). Further, since the pair of needle tip protection portions 72a and 72b are arranged at a separation distance larger than the vertical width dimension of the inner needle 14 in the initial shape, the inner needle 14 is placed from the base end side with respect to the needle tip protector 66. When inserting, it is not necessary to spread between the pair of needle tip protection portions 72a and 72b, and the insertion work of the inner needle 14 is facilitated.
 かくの如き構造とされた留置針組立体10は、内針14と外針18が患者の血管へ穿刺された後、内針14が外針18から引き抜かれることで、留置針16が血管へ穿刺された状態で留置される。 In the indwelling needle assembly 10 having such a structure, the indwelling needle 16 is moved to the blood vessel by pulling out the inner needle 14 from the outer needle 18 after the inner needle 14 and the outer needle 18 are punctured into the blood vessel of the patient. It is indwelled in a punctured state.
 外針18から引き抜かれた内針14は、針先22が針先プロテクタ66によって保護される。即ち、外針18から引き抜かれた内針14は、図10に示すように、針先22が針先プロテクタ66の一対の針先保護部72a,72bの間まで移動する。そして、内針14の係止突起26,26が、第1針挿通部68に対して軸方向で係止される。内針14は、針先22が第2針挿通部92よりも先端側に位置して、第2円形孔94から抜けることなく挿通状態に保たれており、針先22の振れが抑えられている。 The needle tip 22 of the inner needle 14 pulled out from the outer needle 18 is protected by the needle tip protector 66. That is, as shown in FIG. 10, the needle tip 22 of the inner needle 14 pulled out from the outer needle 18 moves between the pair of needle tip protection portions 72a and 72b of the needle tip protector 66. Then, the locking projections 26 and 26 of the inner needle 14 are axially locked with respect to the first needle insertion portion 68. In the inner needle 14, the needle tip 22 is located on the tip side of the second needle insertion portion 92 and is kept in the inserted state without coming out of the second circular hole 94, so that the runout of the needle tip 22 is suppressed. There is.
 内針14を基端へ向けて更に引き抜くと、針先プロテクタ66が内針14とともに基端側へ移動し、針先プロテクタ66が押し子54の入力部56を通過する。針先プロテクタ66が入力部56を通過する際に、一対の針先保護部72a,72bの第2部位78a,78bが押し子54の当接部60に当接して、一対の針先保護部72a,72bの弾性板部74a,74bが変形して相互に接近する。これにより、針先保護部72bは、針先保護部72aが係止片86,86に押し当てられる。係止片86,86は、幅方向の内側へ向けて針先保護部72a側へ傾斜していることから、針先保護部72aが係止片86,86に押し当てられることによって、係止片86,86には相互に離れる方向へ押し広げる力が作用する。その結果、係止片86,86を支持する側壁部84,84が弾性変形して、係止片86,86の間が押し広げられ、針先保護部72bが係止片86,86の間を通って、係止片86,86よりも針先保護部72a側まで移動する(図11,図12参照)。 When the inner needle 14 is further pulled out toward the base end, the needle tip protector 66 moves toward the base end side together with the inner needle 14, and the needle tip protector 66 passes through the input portion 56 of the pusher 54. When the needle tip protector 66 passes through the input portion 56, the second portions 78a and 78b of the pair of needle tip protection portions 72a and 72b abut on the contact portion 60 of the pusher 54, and the pair of needle tip protection portions The elastic plate portions 74a and 74b of 72a and 72b are deformed and approach each other. As a result, the needle tip protection portion 72b is pressed against the locking pieces 86, 86 by the needle tip protection portion 72a. Since the locking pieces 86, 86 are inclined inward in the width direction toward the needle tip protection portion 72a, the locking pieces 86, 86 are locked by being pressed against the locking pieces 86, 86 by the needle tip protection portion 72a. A force that pushes the pieces 86 and 86 apart from each other acts on the pieces 86 and 86. As a result, the side wall portions 84, 84 supporting the locking pieces 86, 86 are elastically deformed, the space between the locking pieces 86, 86 is expanded, and the needle tip protection portion 72b is between the locking pieces 86, 86. It moves to the needle tip protection portion 72a side from the locking pieces 86, 86 (see FIGS. 11 and 12).
 係止片86,86は、針先保護部72bが通過して押し広げる力が解除されると、側壁部84,84の弾性によって初期位置に復帰する。そして、針先保護部72bは、幅方向の両端部が係止片86,86に対して係止され、係止片86,86の間を再び通過することなく、針先保護部72aと針先保護部72bが相互に接近した接近位置に保持される。このように、本実施形態では、針先保護部72bの弾性板部74bと針先保護部72aの係止片86,86との係止によって、針先保護部72aと針先保護部72bを相互に接近した位置に保持する保持機構が構成されている。従って、本実施形態では、針先保護部72aの係止片86,86と、針先保護部72bの弾性板部74bの幅方向端部とが、相互に係止される係止部とされており、当該係止部によって保持機構が構成されている。保持機構は、針先プロテクタ66に一体的に設けられている。なお、針先保護部72aと針先保護部72bは、接近方向へ変位した際に、接近方向に付勢力が生じるようにしてもよいし、逆に離間方向に付勢力が生じるようにしてもよいし、付勢力が生じないようにしてもよい。また、針先保護部は、実施形態の構造に限定されるものではなく、公知構造の針先保護部を適宜に選択して採用することもできる。 The locking pieces 86, 86 return to their initial positions due to the elasticity of the side wall portions 84, 84 when the force to push them out through the needle tip protection portion 72b is released. Then, both ends of the needle tip protection portion 72b in the width direction are locked to the locking pieces 86, 86, and the needle tip protection portion 72a and the needle do not pass between the locking pieces 86, 86 again. The pre-protection portion 72b is held at an approaching position close to each other. As described above, in the present embodiment, the needle tip protection portion 72a and the needle tip protection portion 72b are locked by locking the elastic plate portion 74b of the needle tip protection portion 72b and the locking pieces 86, 86 of the needle tip protection portion 72a. A holding mechanism for holding the needles in close proximity to each other is configured. Therefore, in the present embodiment, the locking pieces 86, 86 of the needle tip protection portion 72a and the widthwise end portion of the elastic plate portion 74b of the needle tip protection portion 72b are regarded as locking portions that are mutually locked. The holding mechanism is configured by the locking portion. The holding mechanism is integrally provided on the needle tip protector 66. When the needle tip protection portion 72a and the needle tip protection portion 72b are displaced in the approaching direction, the urging force may be generated in the approaching direction, or conversely, the urging force may be generated in the separating direction. It may be good, or it may be possible to prevent the force from being generated. Further, the needle tip protection portion is not limited to the structure of the embodiment, and a needle tip protection portion having a known structure can be appropriately selected and adopted.
 内針14の引抜きによって針先保護部72aに対する接近位置へ移動した針先保護部72bの先端部分は、内針14の針先22を先端側において覆っている。要するに、図11に示す接近位置へ移動した針先保護部72bの先端部分は、内針14の先端側への延長線上に位置している。これにより、仮に内針ユニット12を先端側へ押し込む力が作用しても、内針14が針先プロテクタ66を貫通して先端側へ再突出することがなく、使用済みの内針14が誤って穿刺されることがない。このように、針先保護部72a,72bは、相互に接近した接近位置において内針14の針先22を保護するようになっており、針先保護部72a,72bの接近位置が針先22を保護する保護位置とされている。本実施形態の針先保護部72a,72bは、先端部に折返部82a,82bを備えていることから、万が一針先22が弾性板部74a,74bに沿って移動したとしても、針先22が折返部82a,82bによって受け止められることによって移動が制限され、針先22の再突出は生じない。 The tip portion of the needle tip protection portion 72b that has moved to a position closer to the needle tip protection portion 72a by pulling out the inner needle 14 covers the needle tip 22 of the inner needle 14 on the tip side. In short, the tip portion of the needle tip protection portion 72b that has moved to the approach position shown in FIG. 11 is located on the extension line toward the tip side of the inner needle 14. As a result, even if a force that pushes the inner needle unit 12 toward the tip side acts, the inner needle 14 does not penetrate the needle tip protector 66 and re-project toward the tip side, and the used inner needle 14 is erroneously used. Will not be punctured. In this way, the needle tip protection portions 72a and 72b are designed to protect the needle tip 22 of the inner needle 14 at an approaching position close to each other, and the approaching position of the needle tip protection portions 72a and 72b is the needle tip 22. It is said to be a protective position to protect. Since the needle tip protection portions 72a and 72b of the present embodiment are provided with folded portions 82a and 82b at the tip portions, even if the needle tip 22 moves along the elastic plate portions 74a and 74b, the needle tip 22 Is received by the folded- back portions 82a and 82b, so that the movement is restricted and the needle tip 22 does not re-protrude.
 保護位置の針先保護部72aの側壁部84,84は、内針14の針先22に対して左右両側に配されており、針先22の露出が弾性板部74a,74bによる先端側と上下両側だけでなく、左右両側においても防止されている。要するに、針先保護部72a,72bが保護位置へ移動して針先22を保護する状態において、針先プロテクタ66の先端部分が袋状となっており、針先22が当該袋状の先端部分に差し入れられて、針先22の外周側と先端側とが何れも針先プロテクタ66によって覆われている。従って、仮に針先22が上下方向や左右方向に振れたとしても、針先22の移動が針先プロテクタ66の当該袋状の先端部分内に留まり、針先22が患者や医療従事者に触れるのを防ぐことができる。 The side wall portions 84, 84 of the needle tip protection portion 72a at the protection position are arranged on both the left and right sides with respect to the needle tip 22 of the inner needle 14, and the needle tip 22 is exposed to the tip side by the elastic plate portions 74a, 74b. It is prevented not only on both the upper and lower sides but also on both the left and right sides. In short, in a state where the needle tip protection portions 72a and 72b move to the protective position to protect the needle tip 22, the tip portion of the needle tip protector 66 has a bag shape, and the needle tip 22 has the bag-shaped tip portion. The outer peripheral side and the tip side of the needle tip 22 are both covered with the needle tip protector 66. Therefore, even if the needle tip 22 swings in the vertical direction or the horizontal direction, the movement of the needle tip 22 stays in the bag-shaped tip portion of the needle tip protector 66, and the needle tip 22 touches the patient or the medical staff. Can be prevented.
 なお、針先プロテクタ66における一対の針先保護部72a,72bは、相互に離隔した初期位置から押し子54の段差状部分(当接部60)への当接によって相互に接近して閉じた位置に変形することで針先22を覆うようになっていてもよく、例えば、初期位置へ弾性的に保持される一対の針先保護部72a,72bを閉じた位置で係止させることで、初期位置への弾性的な復元を阻止しても良い。好適には、例えば一対の針先保護部72a,72bの基端部分を湾曲断面形状などとしてばね特性を持たせることで、相互に離隔した初期位置と接近して閉じた保護位置との間の境界位置において、それら初期位置と保護位置とに択一的に弾性変形し、初期位置と保護位置との何れか一方に安定して形状保持されるように設定される。尤も、内針14の引抜きに際して閉じた針先プロテクタ66の一対の針先保護部72a,72bを故意に又は意図せずに広げることによる針先再露出を防止するために、一対の針先保護部72a,72bが保護位置へ形状保持される場合でも、一対の針先保護部72a,72bの相互離隔方向への変形を阻止するための係止機構などを設けることが望ましい。 The pair of needle tip protection portions 72a and 72b of the needle tip protector 66 are closed close to each other by contacting the stepped portion (contact portion 60) of the pusher 54 from the initial position separated from each other. The needle tip 22 may be covered by being deformed to a position. For example, by locking a pair of needle tip protection portions 72a and 72b elastically held to the initial position in a closed position, the needle tip 22 may be covered. Elastic restoration to the initial position may be prevented. Preferably, for example, the base end portions of the pair of needle tip protection portions 72a and 72b are provided with spring characteristics as a curved cross-sectional shape, so that the initial position separated from each other and the protected position closed close to each other are preferably used. At the boundary position, the initial position and the protection position are selectively elastically deformed, and the shape is stably maintained in either the initial position or the protection position. However, in order to prevent re-exposure of the needle tip by intentionally or unintentionally expanding the pair of needle tip protection portions 72a, 72b of the needle tip protector 66 that was closed when the inner needle 14 was pulled out, the pair of needle tip protection Even when the shapes of the portions 72a and 72b are maintained in the protective position, it is desirable to provide a locking mechanism for preventing the pair of needle tip protection portions 72a and 72b from being deformed in the direction of mutual separation.
 針先プロテクタ66によって針先22を保護された内針14は、外針ハブ36に対して基端側へ引き抜かれて、図13に示すように、外針ハブ36から分離する。保持機構が針先プロテクタ66の針先保護部72a,72bに設けられていることにより、針先プロテクタ66が外針ハブ36から分離しても、針先保護部72a,72bが相互に接近した保護位置に保持されて、針先22が針先プロテクタ66によって保護される。このように、針先保護部72a,72bを保護位置に保持する保持機構が、針先プロテクタ66自体に設けられていることから、外針ハブ36から分離した針先プロテクタ66の針先保護部72a,72bを保護位置に保持するリング等の別部品を、外針ハブ36に対して分離可能に設ける必要がない。なお、針先プロテクタ66を外針ハブ36から分離する際にスムーズに引き抜けるように、針先プロテクタ66を近接状態で収容し、引抜き時にガイドするガイド部を設けてもよい。ガイド部は、例えば、押し子54の当接部60であってもよいが、例えば、針先プロテクタ66に対してガイド可能な近接状態で設けられていることで、針先プロテクタ66に当接していなくてもよい。 The inner needle 14 whose needle tip 22 is protected by the needle tip protector 66 is pulled out toward the proximal end side with respect to the outer needle hub 36 and is separated from the outer needle hub 36 as shown in FIG. Since the holding mechanism is provided on the needle tip protection portions 72a and 72b of the needle tip protector 66, even if the needle tip protector 66 is separated from the outer needle hub 36, the needle tip protection portions 72a and 72b are close to each other. It is held in the protected position and the needle tip 22 is protected by the needle tip protector 66. As described above, since the holding mechanism for holding the needle tip protection portions 72a and 72b at the protective position is provided on the needle tip protector 66 itself, the needle tip protection portion of the needle tip protector 66 separated from the outer needle hub 36 is provided. It is not necessary to separately provide another part such as a ring for holding the 72a and 72b in the protective position with respect to the outer needle hub 36. The needle tip protector 66 may be accommodated in a close state and a guide portion may be provided to guide the needle tip protector 66 so that the needle tip protector 66 can be smoothly pulled out when the needle tip protector 66 is separated from the outer needle hub 36. The guide portion may be, for example, the contact portion 60 of the pusher 54, but for example, by being provided in a state in which the guide portion can be guided to the needle tip protector 66, the guide portion abuts on the needle tip protector 66. It does not have to be.
 内針ユニット12から分離した留置針16は、外針18が患者の血管へ穿刺された状態で留置される。留置された留置針16は、例えば、図示しない輸液ラインやコネクタやシリンジなどが、外針ハブ36の基端部へ接続される。外針ハブ36に接続されたコネクタやシリンジの雄ルアーが外針ハブ36のルアー挿入部50に挿入されて、押し子54の入力部56の基端に押し当てられることにより、入力部56に押し子54を先端側へ移動させる外力が及ぼされて、押し子54が先端へ向けて押し込まれる。そして、押し子54が先端側へ移動することにより、押し子54の作用部58が弁体62に押し当てられる。これにより、弁体62が弾性変形させられて、弁体62のスリット64が押し開かれ、患者の血管内と輸液ラインやシリンジ等とが開放されたスリット64を通じて相互に連通され、留置針16を通じた輸液や投薬が可能となる。 The indwelling needle 16 separated from the inner needle unit 12 is indwelled with the outer needle 18 punctured into the blood vessel of the patient. In the indwelling needle 16, for example, an infusion line, a connector, a syringe, or the like (not shown) is connected to the base end portion of the outer needle hub 36. The male luer of the connector or syringe connected to the outer needle hub 36 is inserted into the luer insertion portion 50 of the outer needle hub 36 and pressed against the base end of the input portion 56 of the pusher 54 to the input portion 56. An external force that moves the pusher 54 toward the tip side is applied, and the pusher 54 is pushed toward the tip end. Then, as the pusher 54 moves toward the tip end side, the acting portion 58 of the pusher 54 is pressed against the valve body 62. As a result, the valve body 62 is elastically deformed, the slit 64 of the valve body 62 is pushed open, and the inside of the patient's blood vessel and the infusion line, the syringe, etc. are communicated with each other through the opened slit 64, and the indwelling needle 16 is used. Infusion and medication are possible through.
 本実施形態の押し子54において、作用部58の外周端はスリット64の外周端よりも外側に位置しており、作用部58がスリット64に挿入されることなく、弁体62の外周部分を押圧する。それゆえ、例えば、輸液ラインやシリンジが外針ハブ36から取り外されて、雄ルアーによる押し子54の押し込みが解除されると、押し子54が弁体62の弾性的な復元力に基づいて基端側へ移動し、弁体62の閉作動が実現される。これにより、留置状態での頻回利用が可能とされる留置針16において、弁体62を安定して開閉作動させることができる。 In the pusher 54 of the present embodiment, the outer peripheral end of the acting portion 58 is located outside the outer peripheral end of the slit 64, and the outer peripheral portion of the valve body 62 is inserted without the acting portion 58 being inserted into the slit 64. Press. Therefore, for example, when the infusion line or syringe is removed from the outer needle hub 36 and the pusher 54 is released from being pushed by the male luer, the pusher 54 is based on the elastic restoring force of the valve body 62. It moves to the end side, and the closing operation of the valve body 62 is realized. As a result, the valve body 62 can be stably opened and closed in the indwelling needle 16 which can be used frequently in the indwelling state.
 図14,図15には、本発明の第2実施形態としての留置針組立体100の一部が示されている。以下の説明において、第1実施形態と実質的に同一の部材及び部位については、図中に同一の符号を付すことにより説明を省略する。また、本実施形態の留置針組立体100において、図14~図18に示されない部分は、第1実施形態と同様である。 14 and 15 show a part of the indwelling needle assembly 100 as the second embodiment of the present invention. In the following description, the members and parts substantially the same as those in the first embodiment are designated by the same reference numerals in the drawings, and the description thereof will be omitted. Further, in the indwelling needle assembly 100 of the present embodiment, the portions not shown in FIGS. 14 to 18 are the same as those of the first embodiment.
 留置針組立体100は、押し子102を備えている。押し子102は、図16~図18に示すように、基端部分が円筒状の外周面と四角断面の内周面を有する小径筒状の入力部56とされていると共に、先端部分は円筒が特定の軸直角方向(図18中の左右方向)において所定量だけ押しつぶされたような扁平な筒状の作用部104とされている。作用部104は、左右方向が短軸方向となる扁平方向とされ、上下方向が長軸方向とされた略小判形の内形及び外形を有している。これにより、押し子102は、作用部104で構成された先端の開口部分が、直交する2方向において径寸法の最小部分と最大部分とが設定された扁平形状とされている。これにより、押し子102の内部に形成されるプロテクタ収容部55は、作用部104によって壁部が構成された先端部分が、上下方向の内法寸法が左右方向の内法寸法よりも大きくされた扁平形状とされている。作用部104の短軸方向の外周面は、短軸方向に対して略直交して広がる平面とされている。作用部104の長軸方向の外周面は、周方向へ円弧状に湾曲する湾曲面とされている。作用部104の内周面は、外周面と対応する断面形状とされており、短軸方向の幅寸法が入力部56の同方向の幅寸法と略同じとされている。なお、押し子102の先端開口部分の扁平形状は、例示の如き楕円乃至はオーバル形状に限定されるものでなく、例えば長方形の筒形状などであっても良い。 The indwelling needle assembly 100 includes a pusher 102. As shown in FIGS. 16 to 18, the pusher 102 has a small-diameter cylindrical input portion 56 having a cylindrical outer peripheral surface and an inner peripheral surface having a square cross section at the base end portion, and the tip portion is a cylinder. Is a flat cylindrical working portion 104 that is crushed by a predetermined amount in a direction perpendicular to a specific axis (left-right direction in FIG. 18). The working portion 104 has a substantially oval inner shape and an outer shape in which the left-right direction is the short axis direction and the vertical direction is the long axis direction. As a result, the pusher 102 has a flat shape in which the opening portion at the tip formed by the acting portion 104 has a minimum portion and a maximum portion having a diameter dimension set in two orthogonal directions. As a result, in the protector accommodating portion 55 formed inside the pusher 102, the tip portion of the wall portion formed by the working portion 104 has an internal dimension in the vertical direction larger than the internal dimension in the horizontal direction. It has a flat shape. The outer peripheral surface of the working portion 104 in the minor axis direction is a plane extending substantially orthogonal to the minor axis direction. The outer peripheral surface of the working portion 104 in the major axis direction is a curved surface that curves in an arc shape in the circumferential direction. The inner peripheral surface of the working portion 104 has a cross-sectional shape corresponding to the outer peripheral surface, and the width dimension in the minor axis direction is substantially the same as the width dimension in the same direction of the input portion 56. The flat shape of the tip opening portion of the pusher 102 is not limited to an elliptical shape or an oval shape as illustrated, and may be, for example, a rectangular tubular shape.
 作用部104の先端面には、一対の挿入突出部106,106が形成されている。挿入突出部106は、作用部104の扁平方向(短軸方向)の両側にそれぞれ設けられている。挿入突出部106の断面形状は特に限定されないが、弁体62のスリット64へ挿入可能な形状及び寸法とされており、好適には、弁体62のスリット64の開閉方向である上下方向の幅寸法が、左右方向の幅寸法よりも大きくされる。本実施形態の挿入突出部106は、上下方向の両端面が湾曲面とされた略小判形断面で軸方向に延びており、軸直断面においてスリット64の開閉方向である上下方向が長軸方向とされている。挿入突出部106の先端面は、軸方向に対して直交して広がる平面とされているが、例えば、スリット64に対する挿通容易性を高めるために、先端へ向けて上下方向で幅狭となる先細形状等とされていてもよい。各挿入突出部106は、作用部104の先端面において離間距離が小さくなる径方向に配置されており、弁体62の所定部位を強く押圧できるようにされている。なお、各挿入突出部106は、離間距離が大きくなる作用部104の先端面の上下(図16中の上下)に設けられてもよい。挿入突出部106は、複数でなく1つだけであってもよい。挿入突出部106は、設けられていなくてもよい。挿入突出部106を作用部104の先端面の内縁に周状に連続的に設け、作用部104の先端面と当接する弁体62において内側がより大きく変位するようにしてもよい。 A pair of insertion protrusions 106, 106 are formed on the tip surface of the working portion 104. The insertion protrusions 106 are provided on both sides of the working portion 104 in the flat direction (minor axis direction), respectively. The cross-sectional shape of the insertion protrusion 106 is not particularly limited, but has a shape and dimensions that can be inserted into the slit 64 of the valve body 62, and is preferably a width in the vertical direction which is the opening / closing direction of the slit 64 of the valve body 62. The dimension is made larger than the width dimension in the left-right direction. The insertion protrusion 106 of the present embodiment extends in the axial direction in a substantially oval cross section in which both end surfaces in the vertical direction are curved surfaces, and the vertical direction which is the opening / closing direction of the slit 64 in the vertical cross section is the long axis direction. It is said that. The tip surface of the insertion protrusion 106 is a flat surface that extends orthogonally to the axial direction. For example, in order to improve the ease of insertion into the slit 64, the tip surface is tapered in the vertical direction toward the tip. It may be a shape or the like. Each insertion protrusion 106 is arranged in the radial direction on the tip surface of the action portion 104 so that the separation distance becomes small, so that a predetermined portion of the valve body 62 can be strongly pressed. In addition, each insertion protrusion 106 may be provided above and below (up and down in FIG. 16) the tip surface of the action portion 104 where the separation distance becomes large. The number of insertion protrusions 106 may be only one instead of a plurality. The insertion protrusion 106 may not be provided. The insertion protrusion 106 may be continuously provided on the inner edge of the tip surface of the action portion 104 in a circumferential shape so that the inside of the valve body 62 in contact with the tip surface of the action portion 104 is displaced more greatly.
 押し子102は、図14,図15に示すように、外針ハブ36の内部に収容されており、内部に針先プロテクタ66を収容している。針先プロテクタ66は、針先22を保護する前の初期形状において、針先保護部72a,72bが先端へ向けて上下外側へ傾斜する第2部位78a,78bを備えていることから、針先保護部72a,72bの離隔対向方向である上下方向において左右方向よりも外法寸法が大きくされている。それゆえ、針先プロテクタ66の先端部分が左右方向で扁平とされた作用部104のプロテクタ収容部55に収容されることにより、針先プロテクタ66と作用部104の内面との間の空隙が低減される。これにより、プロテクタ収容部55を備える押し子102や、押し子102を収容する外針ハブ36の小型化を図ることができる。特に、作用部104の扁平方向である左右方向において、押し子102等の小型化が実現され易くなる。 As shown in FIGS. 14 and 15, the pusher 102 is housed inside the outer needle hub 36, and the needle tip protector 66 is housed inside. Since the needle tip protector 66 has a second portion 78a, 78b in which the needle tip protection portions 72a, 72b are inclined up and down and outward toward the tip in the initial shape before protecting the needle tip 22, the needle tip protector 66 has a needle tip. The outer dimensions are larger than those in the left-right direction in the vertical direction, which is the direction in which the protective portions 72a and 72b face each other. Therefore, by accommodating the tip portion of the needle tip protector 66 in the protector accommodating portion 55 of the acting portion 104 flattened in the left-right direction, the gap between the needle tip protector 66 and the inner surface of the acting portion 104 is reduced. Will be done. As a result, the pusher 102 provided with the protector accommodating portion 55 and the outer needle hub 36 accommodating the pusher 102 can be miniaturized. In particular, in the left-right direction, which is the flat direction of the working portion 104, miniaturization of the pusher 102 or the like can be easily realized.
 そして、血管等に留置された留置針16に図示しない雄ルアーが挿入されて押し子102が先端側へ押し込まれると、押し子102の一対の挿入突出部106,106が弁体62のスリット64を押し広げながらスリット64へ挿入される。これにより、図18に2点鎖線で仮想的に示すように、弁体62のスリット64が押し子102の挿入突出部106,106によって大きく拡げられて、スリット64が開放状態とされる。本実施形態の挿入突出部106は、上下方向に長尺の断面形状を有していることから、スリット64へ挿入されることによって、スリット64をより大きく拡げて確実に開放させることができる。なお、図18において、スリット64は、左右方向に延びる一文字とされており、上下方向に開くようにされているが、Y字や十字等の複数方向で放射状に延びるスリットとすることもできる。 Then, when a male luer (not shown) is inserted into the indwelling needle 16 placed in the blood vessel or the like and the pusher 102 is pushed toward the tip side, the pair of insertion protrusions 106 and 106 of the pusher 102 are inserted into the slit 64 of the valve body 62. Is inserted into the slit 64 while spreading. As a result, as virtually shown by the two-dot chain line in FIG. 18, the slit 64 of the valve body 62 is greatly expanded by the insertion protrusions 106 and 106 of the pusher 102, and the slit 64 is opened. Since the insertion protrusion 106 of the present embodiment has a long cross-sectional shape in the vertical direction, the slit 64 can be expanded more and surely opened by being inserted into the slit 64. In FIG. 18, the slit 64 is a single character extending in the left-right direction and is designed to open in the vertical direction, but it may also be a slit extending radially in a plurality of directions such as a Y-shape or a cross.
 また、押し子102の先端面において挿入突出部106,106を外れた部分は、スリット64よりも外周において弁体62の基端面に押し当てられる。これにより、弁体62の開状態において、弁体62が押し子102によって先端側へ押し込まれて弾性変形した状態とされている。そして、外針ハブ36から雄ルアーが取り外されて、押し子102を先端側へ押し込む外力が解除されると、押し子102は、弁体62の弾性に基づいて基端側へ押し戻される。特に、作用部104は、入力部56に比して外径が大きくされており、作用部104は弁体62の外周側を押圧することになるため、押し子102に対して弁体62から基端方向へ向けた力が伝わり易く、押し子102が安定して基端側へ押し戻される。このように、押し子102が弁体62の弾性によって基端へ向けて移動することにより、スリット64に挿入された挿入突出部106,106がスリット64から抜け出す。その結果、スリット64が閉じて、血管内と外部の連通が阻止される。従って、留置針16に対する輸液ラインやシリンジ等の外部ラインの着脱に応じて、弁体62が開閉作動されて、一度開いた弁体62が閉じなくなるのを防ぐことができる。 Further, the portions of the tip surface of the pusher 102 that are out of the insertion protrusions 106 and 106 are pressed against the base end surface of the valve body 62 on the outer periphery of the slit 64. As a result, in the open state of the valve body 62, the valve body 62 is pushed toward the tip side by the pusher 102 and is elastically deformed. Then, when the male lure is removed from the outer needle hub 36 and the external force for pushing the pusher 102 toward the tip end side is released, the pusher 102 is pushed back to the base end side based on the elasticity of the valve body 62. In particular, the acting portion 104 has a larger outer diameter than the input portion 56, and the acting portion 104 presses the outer peripheral side of the valve body 62. The force toward the proximal end is easily transmitted, and the pusher 102 is stably pushed back to the proximal end side. In this way, the pusher 102 moves toward the proximal end due to the elasticity of the valve body 62, so that the insertion protrusions 106, 106 inserted into the slit 64 come out of the slit 64. As a result, the slit 64 is closed and communication between the inside and the outside of the blood vessel is blocked. Therefore, it is possible to prevent the valve body 62 from being opened and closed in response to the attachment / detachment of an infusion line or an external line such as a syringe to the indwelling needle 16 so that the valve body 62 once opened cannot be closed.
 図19には、本発明の第3実施形態としての留置針組立体110の一部が示されている。留置針組立体110は、押し子112を備えている。本実施形態の留置針組立体110において、図19,図20に示されない部分は、第1実施形態と同様である。 FIG. 19 shows a part of the indwelling needle assembly 110 as the third embodiment of the present invention. The indwelling needle assembly 110 includes a pusher 112. In the indwelling needle assembly 110 of the present embodiment, the parts not shown in FIGS. 19 and 20 are the same as those of the first embodiment.
 押し子112は、図20にも示すように、基端部材としての押し子本体114と、押し子本体114の先端側の開口部に取り付けられた先端部材としての開閉部材116とを備えている。押し子本体114と開閉部材116は、別部材として独立して形成されており、例えば、接着や溶着、嵌合、かしめ等の手段で相互に固定されることによって、押し子112を構成している。押し子本体114は、第1実施形態の押し子54と同様の構造を有しており、入力部56と作用部58を備えている。 As shown in FIG. 20, the pusher 112 includes a pusher body 114 as a base end member and an opening / closing member 116 as a tip member attached to an opening on the tip end side of the pusher body 114. .. The pusher body 114 and the opening / closing member 116 are independently formed as separate members, and for example, the pusher 112 is formed by being fixed to each other by means such as adhesion, welding, fitting, and caulking. There is. The pusher main body 114 has the same structure as the pusher 54 of the first embodiment, and includes an input unit 56 and an action unit 58.
 開閉部材116は、作用部58と略同じ外径寸法を有する略円板形状の取付部118を備え、取付部118が押し子本体114の先端開口を覆っている。開閉部材116は、中央部を厚さ方向に貫通する貫通孔120を備えており、貫通孔120の開口周縁部が取付部118から先端へ向けて突出する挿入部としての挿入筒部122とされている。挿入筒部122は、取付部118よりも小径の略円筒形状とされており、弁体62のスリット64へ挿入可能とされている。本実施形態の挿入筒部122は、略一定の外径寸法で延びる円筒状とされているが、例えば、挿入筒部は、スリット64に対してより挿入及び抜去し易くするために、先端へ向けて先細となるテーパ筒状とすることもできる。 The opening / closing member 116 includes a substantially disk-shaped mounting portion 118 having substantially the same outer diameter as the working portion 58, and the mounting portion 118 covers the tip opening of the pusher main body 114. The opening / closing member 116 is provided with a through hole 120 that penetrates the central portion in the thickness direction, and is an insertion cylinder portion 122 as an insertion portion in which the opening peripheral portion of the through hole 120 projects from the mounting portion 118 toward the tip end. ing. The insertion cylinder portion 122 has a substantially cylindrical shape having a smaller diameter than the mounting portion 118, and can be inserted into the slit 64 of the valve body 62. The insertion cylinder portion 122 of the present embodiment has a cylindrical shape extending with a substantially constant outer diameter, but for example, the insertion cylinder portion is moved to the tip thereof in order to make it easier to insert and remove from the slit 64. It can also be a tapered cylinder that tapers toward it.
 押し子112は、図19に示すように、外針ハブ36の内部に収容されており、内部に針先プロテクタ66を収容している。そして、留置された留置針16に図示しない雄ルアーが挿入されて押し子112が先端側へ押し込まれると、押し子112の先端に設けられた挿入筒部122が、弁体62のスリット64を押し広げながらスリット64へ挿入される。これにより、弁体62のスリット64が押し子112の挿入筒部122によって拡げられて、スリット64が開放状態とされる。 As shown in FIG. 19, the pusher 112 is housed inside the outer needle hub 36, and the needle tip protector 66 is housed inside. Then, when a male luer (not shown) is inserted into the indwelling needle 16 and the pusher 112 is pushed toward the tip side, the insertion tube portion 122 provided at the tip of the pusher 112 inserts the slit 64 of the valve body 62. It is inserted into the slit 64 while being pushed open. As a result, the slit 64 of the valve body 62 is expanded by the insertion cylinder portion 122 of the pusher 112, and the slit 64 is opened.
 また、挿入筒部122を外周へ外れた取付部118の先端面は、スリット64よりも外周において弁体62の基端面に押し当てられる。これにより、開状態の弁体62は、押し子112によって先端側へ押し込まれて弾性変形した状態とされている。そして、外針ハブ36から雄ルアーが取り外されて、押し子112を先端側へ押し込む外力が解除されると、押し子112は、弁体62の弾性に基づいて基端側へ押し戻される。このように、押し子112が弁体62の弾性によって基端へ向けて移動することにより、スリット64に挿入された挿入筒部122がスリット64から抜け出す。その結果、スリット64が閉じて、血管内と外部の連通が阻止される。従って、留置針16に対する輸液ラインやシリンジ等の外部ラインの着脱に応じて、弁体62が開閉作動されて、一度開いた弁体62が閉じなくなるのを防ぐことができる。 Further, the tip surface of the mounting portion 118 deviating from the insertion cylinder portion 122 to the outer periphery is pressed against the base end surface of the valve body 62 on the outer periphery rather than the slit 64. As a result, the valve body 62 in the open state is pushed toward the tip side by the pusher 112 and is elastically deformed. Then, when the male lure is removed from the outer needle hub 36 and the external force for pushing the pusher 112 toward the tip end side is released, the pusher 112 is pushed back to the base end side based on the elasticity of the valve body 62. In this way, the pusher 112 moves toward the proximal end due to the elasticity of the valve body 62, so that the insertion cylinder portion 122 inserted into the slit 64 comes out of the slit 64. As a result, the slit 64 is closed and communication between the inside and the outside of the blood vessel is blocked. Therefore, it is possible to prevent the valve body 62 from being opened and closed in response to the attachment / detachment of an infusion line or an external line such as a syringe to the indwelling needle 16 so that the valve body 62 once opened cannot be closed.
 押し子112が押し子本体114と開閉部材116の2部品を組み合わせた構造とされていることから、押し子112の基端部分に要求される性能と、押し子112の先端部分に要求される性能とを、それぞれ高度に実現することができる。例えば、本実施形態に係る押し子112を採用すれば、押し子112の基端部分を構成する押し子本体114によって、針先プロテクタ66の収容に必要な内部空間などを確保しながら、押し子112の先端部分を構成する開閉部材116によって、弁体62のスリット64の開作動を安定して実現することができる。 Since the pusher 112 has a structure in which two parts of the pusher body 114 and the opening / closing member 116 are combined, the performance required for the base end portion of the pusher 112 and the tip portion of the pusher 112 are required. Performance can be achieved to a high degree. For example, if the pusher 112 according to the present embodiment is adopted, the pusher main body 114 constituting the base end portion of the pusher 112 secures the internal space required for accommodating the needle tip protector 66, and the pusher. The opening / closing member 116 constituting the tip portion of the 112 can stably realize the opening operation of the slit 64 of the valve body 62.
 以上、本発明の実施形態について詳述してきたが、本発明はその具体的な記載によって限定されない。例えば、前記実施形態では、針先保護部72a,72bが側壁部84,84から突出する係止片86,86と弾性板部74bの側縁部との係止によって保持機構が構成される例を示したが、保持機構を設ける位置は特に限定されない。具体的には、例えば、針先保護部72bの先端が針先保護部72aの折返部82aに係止されることによって、保持機構を構成することもできる。また、例えば、針先保護部72a,72bと位置決め部88との間に係止構造を設けることによって、保持機構を構成することも可能である。 Although the embodiments of the present invention have been described in detail above, the present invention is not limited by the specific description thereof. For example, in the above embodiment, the holding mechanism is configured by locking the locking pieces 86, 86 in which the needle tip protection portions 72a, 72b project from the side wall portions 84, 84 and the side edge portions of the elastic plate portion 74b. However, the position where the holding mechanism is provided is not particularly limited. Specifically, for example, the holding mechanism can be configured by engaging the tip of the needle tip protection portion 72b with the folded-back portion 82a of the needle tip protection portion 72a. Further, for example, a holding mechanism can be configured by providing a locking structure between the needle tip protection portions 72a and 72b and the positioning portion 88.
 前記実施形態では、針先プロテクタ66を針先保護状態に移行させる当接部60が、押し子54の作用部58から内周へ突出する段差状に設けられていたが、例えば、押し子54の入力部56から更に内周へ突出する突条とされていてもよい。 In the above embodiment, the contact portion 60 for shifting the needle tip protector 66 to the needle tip protection state is provided in a stepped shape protruding inward from the action portion 58 of the pusher 54. For example, the pusher 54 is provided. It may be a ridge that further protrudes from the input portion 56 of the above to the inner circumference.
 また、当接部60は、必ずしも押し子54に設けられなくてもよく、例えば、押し子54の基端側に切欠部を形成し、当接部60を外針ハブ36の内周面に設けることもできる。なお、当接部60を外針ハブ36の内周面に設ける場合、例えばルアー連結部材の内面に径方向内方へ突出する当接部を形成してもよいし、ルアー連結部材とは別の部材をルアー連結部材に組み付けることで当接部を実現してもよい。また、当接部はなくてもよい。 Further, the contact portion 60 does not necessarily have to be provided on the pusher 54. For example, a notch is formed on the base end side of the pusher 54, and the contact portion 60 is placed on the inner peripheral surface of the outer needle hub 36. It can also be provided. When the contact portion 60 is provided on the inner peripheral surface of the outer needle hub 36, for example, a contact portion that protrudes inward in the radial direction may be formed on the inner surface of the lure connecting member, and is separate from the luer connecting member. The contact portion may be realized by assembling the member of the above to the luer connecting member. Further, the contact portion may not be provided.
 前記第1~第3実施形態の押し子54,102,112を採用する場合に、針先プロテクタ66の構造は限定されるものではなく、各種公知構造の針先プロテクタを組み合わせて採用することもできる。また、針先プロテクタ66がない場合や、針先プロテクタ66が押し子54,102,112に収容されていない場合にも、前記実施形態の押し子54,102,112を採用し得る。 When the pushers 54, 102, 112 of the first to third embodiments are adopted, the structure of the needle tip protector 66 is not limited, and needle tip protectors having various known structures may be adopted in combination. can. Further, even when the needle tip protector 66 is not provided or the needle tip protector 66 is not housed in the pusher 54, 102, 112, the pusher 54, 102, 112 of the above embodiment can be adopted.
 前記第3実施形態の押し子112は、基端部材としての押し子本体114と、先端部材としての開閉部材116とを組み合わせて構成された2部品構成とされていたが、例えば、押し子本体114の作用部58と入力部56が別部品とされるなどして、押し子を3つ以上の部品で構成することもできる。 The pusher 112 of the third embodiment has a two-part configuration in which a pusher main body 114 as a base end member and an opening / closing member 116 as a tip end member are combined. For example, the pusher main body. The pusher may be composed of three or more parts, for example, the working part 58 and the input part 56 of the 114 are made into separate parts.
 前記実施形態では、押し子の内部に針先プロテクタが収容されていたが、針先プロテクタ以外の部品が押し子の内部に収容されていてもよい。具体的には、例えば、針先プロテクタに外挿されたコイルスプリングを押し子の作用部の内部に配することもできる。これによれば、例えば、内針の引抜きに際して、針先プロテクタの先端部分がコイルスプリングの内周を通過して、針先プロテクタの針先保護部が保護位置へ移動するようにできる。また、押し子が弁体に押し当てられる際にコイルスプリングが圧縮されるようにすれば、押し子を押し込む力が解除される際に、コイルスプリングの弾性によって押し子を基端側へ移動させて、弁体を速やかに閉状態に移行させることができる。 In the above embodiment, the needle tip protector is housed inside the pusher, but parts other than the needle tip protector may be housed inside the pusher. Specifically, for example, a coil spring extrapolated to the needle tip protector can be arranged inside the acting portion of the pusher. According to this, for example, when the inner needle is pulled out, the tip portion of the needle tip protector passes through the inner circumference of the coil spring, and the needle tip protection portion of the needle tip protector can be moved to the protected position. Further, if the coil spring is compressed when the pusher is pressed against the valve body, the pusher is moved to the base end side by the elasticity of the coil spring when the force for pushing the pusher is released. Therefore, the valve body can be quickly moved to the closed state.
 押し子の内部に針先プロテクタが収容される場合に、必ずしも針先プロテクタの全体が押し子の内部に収容される必要はない。例えば、針先プロテクタの先端部分が押し子の内部へ収容され、基端部分が押し子よりも基端に露出する等、針先プロテクタは押し子の内部へ部分的に収容されていてもよい、 When the needle tip protector is housed inside the pusher, the entire needle tip protector does not necessarily have to be housed inside the pusher. For example, the needle tip protector may be partially housed inside the pusher, for example, the tip portion of the needle tip protector is housed inside the pusher and the base end portion is exposed to the base end rather than the pusher. ,
 押し子の作用部は、内径だけでなく外径も入力部よりも大きくされていたが、例えば、作用部は、内径が入力部よりも大きく、外径が入力部と同じであってもよい。 The working part of the pusher has not only the inner diameter but also the outer diameter larger than the input part. For example, the working part may have an inner diameter larger than the input part and the outer diameter the same as the input part. ..
10 留置針組立体(第1実施形態)
12 内針ユニット
14 内針
16 留置針
18 外針
20 内針ハブ
22 針先
26 係止突起
28 ハブ本体
30 内針保持部
32 鍔状部
34 キャップ部材
35 通気性フィルタ
36 外針ハブ
38 針固着部材
40 ルアー連結部材
42 テーパ部
44 係合孔
46 段差
48 ハブ連結部
50 ルアー挿入部
52 係合爪
54 押し子
55 プロテクタ収容部
56 入力部(小筒部)
58 作用部(大筒部)
60 当接部
62 弁体
64 スリット
66 針先プロテクタ
68 第1針挿通部
70 第1円形孔
72 針先保護部
74 弾性板部
76 第1部位
78 第2部位
80 第3部位
82 折返部
84 側壁部
85 切込み
86 係止片
88 位置決め部
90 支持部
92 第2針挿通部
94 第2円形孔
100 留置針組立体(第2実施形態)
102 押し子
104 作用部
106 挿入突出部
110 留置針組立体(第3実施形態)
112 押し子
114 押し子本体(基端部材)
116 開閉部材(先端部材)
118 取付部
120 貫通孔
122 挿入筒部
10 Indwelling needle assembly (first embodiment)
12 Inner needle unit 14 Inner needle 16 Indwelling needle 18 Outer needle 20 Inner needle hub 22 Needle tip 26 Locking protrusion 28 Hub body 30 Inner needle holding part 32 Taper-shaped part 34 Cap member 35 Breathable filter 36 Outer needle hub 38 Needle fixation Member 40 Lure connecting member 42 Taper part 44 Engagement hole 46 Step 48 Hub connecting part 50 Lure insertion part 52 Engagement claw 54 Pusher 55 Protector accommodating part 56 Input part (small cylinder part)
58 Acting part (large cylinder part)
60 Contact part 62 Valve body 64 Slit 66 Needle tip protector 68 First needle insertion part 70 First circular hole 72 Needle tip protection part 74 Elastic plate part 76 First part 78 Second part 80 Second part 80 Third part 82 Folded part 84 Side wall Part 85 Notch 86 Locking piece 88 Positioning part 90 Support part 92 Second needle insertion part 94 Second circular hole 100 Indwelling needle assembly (second embodiment)
102 Pusher 104 Acting part 106 Insertion protruding part 110 Indwelling needle assembly (third embodiment)
112 Pusher 114 Pusher body (base member)
116 Opening and closing member (tip member)
118 Mounting part 120 Through hole 122 Insertion cylinder part

Claims (7)

  1.  基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されていると共に、該外針から引き抜かれた該内針の針先を保護する針先プロテクタを備えた留置針組立体であって、
     前記針先プロテクタは前記内針から側方へ離れて位置する針先保護部を有しており、
     該内針の前記外針からの引抜きに際して前記外針ハブに止まって該針先保護部に当接して、該針先保護部を該内針への接近側へ変位させることで引き抜かれた該内針の針先を覆う保護位置へ導く当接部を備えていると共に、
     該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配されており、該針先プロテクタの少なくとも一部が該押し子の内部に収容されている留置針組立体。
    An inner needle having an inner needle hub on the proximal end side is inserted into an outer needle having an outer needle hub on the proximal end side so as to be retractable, and protects the needle tip of the inner needle pulled out from the outer needle. An indwelling needle assembly with a needle tip protector
    The needle tip protector has a needle tip protection portion located laterally away from the inner needle.
    When the inner needle was pulled out from the outer needle, the needle was pulled out by stopping at the outer needle hub, contacting the needle tip protection portion, and displacing the needle tip protection portion toward the inner needle. It is equipped with a contact part that leads to a protective position that covers the needle tip of the inner needle, and also has a contact part.
    An indwelling needle assembly in which a pusher for switching the valve body is arranged on the proximal end side of the valve body inside the outer needle hub, and at least a part of the needle tip protector is housed inside the pusher. ..
  2.  基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されており、該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配された留置針組立体であって、
     前記外針から引き抜かれた前記内針の針先を保護する針先プロテクタの少なくとも一部が前記押し子の内部に収容されて、
     該押し子は小筒部と大筒部を備えており、
     該大筒部は該小筒部より先端側に形成され、該大筒部は該小筒部よりも内法寸法が大きくされている留置針組立体。
    An inner needle having an inner needle hub on the proximal end side is inserted into an outer needle having an outer needle hub on the proximal end side so as to be retractable, and a pusher for switching the valve body inside the outer needle hub is the valve. An indwelling needle assembly placed on the base end side of the body,
    At least a part of the needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle is housed inside the pusher.
    The pusher has a small cylinder portion and a large cylinder portion, and the pusher has a small cylinder portion and a large cylinder portion.
    An indwelling needle assembly in which the large cylinder portion is formed on the tip side of the small cylinder portion, and the large cylinder portion has a larger internal dimension than the small cylinder portion.
  3.  基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されており、該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配された留置針組立体であって、
     前記外針から引き抜かれた前記内針の針先を保護する針先プロテクタの少なくとも一部が前記押し子の内部に収容されて、
     該押し子は、該押し子を前記弁体へ押し付ける外力が入力される入力部と、該入力部よりも先端側に設けられて該弁体を押し開く作用部とを備えており、
     該作用部が該入力部よりも大径とされている留置針組立体。
    An inner needle having an inner needle hub on the proximal end side is inserted into an outer needle having an outer needle hub on the proximal end side so as to be retractable, and a pusher for switching the valve body inside the outer needle hub is the valve. An indwelling needle assembly placed on the base end side of the body,
    At least a part of the needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle is housed inside the pusher.
    The pusher includes an input portion to which an external force for pressing the pusher against the valve body is input, and an action portion provided on the tip side of the input portion to push the valve body open.
    An indwelling needle assembly in which the working portion has a larger diameter than the input portion.
  4.  前記弁体には、内周部分を前記内針の針軸方向に貫通するスリットが形成されており、
     前記作用部の外周端が該スリットの外周端よりも外周に位置している請求項3に記載の留置針組立体。
    The valve body is formed with a slit that penetrates the inner peripheral portion in the needle axis direction of the inner needle.
    The indwelling needle assembly according to claim 3, wherein the outer peripheral end of the working portion is located on the outer periphery of the outer peripheral end of the slit.
  5.  基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されており、該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配された留置針組立体であって、
     前記外針から引き抜かれた前記内針の針先を保護する針先プロテクタの少なくとも一部が前記押し子の内部に収容されて、
     該押し子は、基端部材の先端側の開口部に取り付けられた先端部材を含んでおり、
     該基端部材の先端側の開口部の少なくとも一部が該先端部材によって塞がれている留置針組立体。
    An inner needle having an inner needle hub on the proximal end side is inserted into an outer needle having an outer needle hub on the proximal end side so as to be retractable, and a pusher for switching the valve body inside the outer needle hub is the valve. An indwelling needle assembly placed on the base end side of the body,
    At least a part of the needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle is housed inside the pusher.
    The pusher includes a tip member attached to an opening on the tip side of the base member.
    An indwelling needle assembly in which at least a part of the opening on the distal end side of the proximal end member is closed by the distal end member.
  6.  基端側に内針ハブを有する内針が基端側に外針ハブを有する外針に対して引抜可能に挿通されており、該外針ハブの内部において弁体を切り換える押し子が該弁体より基端側に配された留置針組立体であって、
     前記外針から引き抜かれた前記内針の針先を保護する針先プロテクタを備えており、
     前記押し子の先端の開口部分が扁平の筒状とされていると共に、
     扁平の筒状とされた該押し子の内部には該針先プロテクタの少なくとも一部を収容するプロテクタ収容部が設けられている留置針組立体。
    An inner needle having an inner needle hub on the proximal end side is inserted into an outer needle having an outer needle hub on the proximal end side so as to be retractable, and a pusher for switching the valve body inside the outer needle hub is the valve. An indwelling needle assembly placed on the base end side of the body,
    It is equipped with a needle tip protector that protects the needle tip of the inner needle pulled out from the outer needle.
    The opening at the tip of the pusher has a flat cylindrical shape, and at the same time,
    An indwelling needle assembly provided with a protector accommodating portion for accommodating at least a part of the needle tip protector inside the pusher having a flat tubular shape.
  7.  前記押し子には、扁平方向の両側において先端へ向けて突出し、前記弁体に形成されたスリットへ挿し入れ可能な挿入突出部が設けられている請求項6に記載の留置針組立体。 The indwelling needle assembly according to claim 6, wherein the pusher is provided with an insertion protrusion that protrudes toward the tip on both sides in the flat direction and can be inserted into a slit formed in the valve body.
PCT/JP2021/043841 2020-12-01 2021-11-30 Indwelling needle assembly WO2022118837A1 (en)

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Citations (5)

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JP2012517326A (en) * 2009-02-11 2012-08-02 ベクトン・ディキンソン・アンド・カンパニー System and method for providing a washable catheter assembly
JP2018527984A (en) * 2015-08-18 2018-09-27 ベー・ブラウン・メルズンゲン・アクチエンゲゼルシャフトB.Braun Melsungen Aktiengesellschaft Catheter apparatus with valve and related methods
US20200188634A1 (en) * 2018-12-17 2020-06-18 B. Braun Melsungen Ag Catheter assemblies and related methods
JP2020142019A (en) * 2019-03-08 2020-09-10 ニプロ株式会社 Needle assembly with valve
WO2020209368A1 (en) * 2019-04-11 2020-10-15 ニプロ株式会社 Indwelling needle assembly

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012517326A (en) * 2009-02-11 2012-08-02 ベクトン・ディキンソン・アンド・カンパニー System and method for providing a washable catheter assembly
JP2018527984A (en) * 2015-08-18 2018-09-27 ベー・ブラウン・メルズンゲン・アクチエンゲゼルシャフトB.Braun Melsungen Aktiengesellschaft Catheter apparatus with valve and related methods
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