WO2013027355A1 - Indwelling needle assembly - Google Patents

Indwelling needle assembly Download PDF

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Publication number
WO2013027355A1
WO2013027355A1 PCT/JP2012/005053 JP2012005053W WO2013027355A1 WO 2013027355 A1 WO2013027355 A1 WO 2013027355A1 JP 2012005053 W JP2012005053 W JP 2012005053W WO 2013027355 A1 WO2013027355 A1 WO 2013027355A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
magnet
inner needle
outer needle
cap
Prior art date
Application number
PCT/JP2012/005053
Other languages
French (fr)
Japanese (ja)
Inventor
健志 山口
Original Assignee
二プロ株式会社
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 二プロ株式会社 filed Critical 二プロ株式会社
Priority to JP2013529858A priority Critical patent/JP5880983B2/en
Publication of WO2013027355A1 publication Critical patent/WO2013027355A1/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
    • A61M25/0612Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0618Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3273Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel freely sliding on needle shaft without connection to syringe or needle
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3223Means impeding or disabling repositioning of used needles at the syringe nozzle
    • A61M2005/3226Means impeding or disabling repositioning of used needles at the syringe nozzle with means obstructing or blocking the needle mounting opening
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Definitions

  • the present invention relates to an indwelling needle assembly that is punctured and placed in a blood vessel when performing infusion, blood collection, hemodialysis, and the like, and in particular, includes a needle tip protector that protects the needle tip of an inner needle after use.
  • the present invention relates to an indwelling needle assembly.
  • an indwelling needle assembly in which an outer needle of an outer needle unit is passed through and an inner needle of an inner needle unit is assembled is known.
  • the indwelling needle assembly punctures a patient's blood vessel, and then removes the inner needle unit including the inner needle from the outer needle unit including the outer needle, thereby removing the outer needle from the patient. It is used for treatment by placing it in the blood vessel.
  • the inner needle of the inner needle unit removed from the outer needle unit after puncturing the patient's blood vessel has a sharp needle tip at its distal end, and this needle tip is a doctor, nurse, or waste disposal company.
  • an accidental puncture accident may occur.
  • Such an erroneous puncture accident may cause infection such as AIDS or virus from blood or the like adhering to the needle tip, and it is important to prevent it beforehand.
  • an indwelling needle assembly including a protector has been proposed in which when the inner needle is pulled out from the outer needle, a slide-type cover provided in the inner needle unit is extended to accommodate the entire inner needle.
  • a protector for example, the one described in Japanese Patent No. 3400550 (Patent Document 1) and Japanese Patent Laid-Open No. 7-148270 (Patent Document 2).
  • Patent Document 3 Japanese Patent Laid-Open No. 2002-102345 (Patent Document 3), a spring-type needle tip protector is disposed in the outer needle unit, and the needle tip protector is detached from the outer needle unit by pulling out the inner needle. It has been proposed to cover the needle tip.
  • the protector since the protector is structured to cover the entire inner needle, there is a problem that the indwelling needle assembly itself cannot be increased in size. . Further, in the case of a spring-type needle tip protector, there is a problem that a biasing force of the spring is applied when the inner needle is pulled out, and a large force is required when the inner needle is pulled out. In addition, the tip of the inner needle may re-project from the protector.
  • Patent Document 4 Japanese Patent No. 4661240
  • Patent Document 4 includes a needle tip protector that can accommodate only a needle tip that is slidably attached to the inner needle, and is proximal to the needle tip protector. While the end is not removable from the inner needle, the distal end opening of the needle tip protector is positioned against the magnet when the needle tip of the inner needle is housed in the needle tip protector from the opening.
  • a structure has been proposed in which a cover member made of a magnetic material or magnet is adsorbed to close the distal opening of the needle tip protector. According to such a structure, since the needle tip is protected by the small needle tip protector that accommodates only the needle tip, an increase in the size of the indwelling needle assembly can be avoided.
  • the biasing force of the spring is not exerted when the inner needle is pulled out, it is possible to avoid an increase in the pulling force of the inner needle. Furthermore, since the distal side opening of the needle tip protector is closed by the closing member attracted by the magnetic force, the closing member can be stably held in the closed position, and the opening is surely opened again. It was a breakthrough that could be prevented. Further, the applicant of the present application can realize highly reliable protection of the needle tip without causing an increase in the size of the magnet or the like even when the inner needle has a large diameter in the indwelling needle assembly having the previously proposed structure. We have been studying further improved structures.
  • the present invention has been made in the background of the above-mentioned circumstances, and the problem to be solved is that, even when the inner needle has a large diameter, without enlarging the magnet, the outer needle unit, and the inner needle unit, It is an object of the present invention to provide an indwelling needle assembly having a novel structure capable of reliably adsorbing a closing member to a magnet and stably realizing protection of the needle tip by a needle tip protector.
  • the first aspect of the present invention includes an inner needle having a needle tip at a distal end, an inner needle hub attached to the proximal end of the inner needle, and movement in the needle axis direction with respect to the inner needle.
  • An inner needle unit having a needle tip protector attached thereto, an outer needle through which the inner needle can be inserted, an outer needle hub attached to the proximal end of the outer needle and through which the inner needle can be inserted;
  • An outer needle unit that is detachably attached to the proximal end of the outer needle hub and through which the inner needle can be inserted and has an outer needle cap that covers the proximal end of the outer needle hub.
  • a needle is inserted into the outer needle cap and the outer needle hub and accommodated in the outer needle, and the inner needle unit is brought into contact with the outer needle cap by contacting the inner needle unit with the outer needle cap.
  • the inner needle unit The needle tip protector includes a cylindrical portion through which the inner needle is inserted, and a distal side opening through which the inner needle is inserted is formed on the distal side of the cylindrical portion.
  • a first magnet having magnetic poles arranged in a direction perpendicular to the axis is fixedly disposed on one side of the direction perpendicular to the axis of the needle across the distal opening.
  • a closing member that can be attracted to the first magnet and can close the distal opening is disposed on the other side in the straight direction so as to be movable toward the first magnet, and the cylindrical portion.
  • a proximal opening through which the inner needle is inserted is formed on the proximal side of the inner needle, and the needle tip of the inner needle is assembled so as not to come out of the proximal opening.
  • a second magnet is disposed on the outer needle cap of the outer needle unit, and in an assembled state of the outer needle unit and the inner needle unit, The magnetic poles of the second magnet are arranged in the axial direction in the same manner as the first magnet, and the second magnet is arranged on the outer side of the first magnet in the axial direction.
  • the indwelling needle assembly is characterized in that the needle tip protector is detachably attracted to the outer needle cap by the attractive force of the first magnet and the second magnet.
  • the needle tip protector adsorbed to the outer needle cap as the inner needle moves in the pulling direction is moved distally in the needle axis direction.
  • the inner needle is detached from the distal opening of the cylindrical portion, and the closing member is attracted by the first and second magnets to close the distal opening.
  • the inner needle unit is in a state where the needle tip is housed inside the cylindrical portion of the needle tip protector by preventing the needle tip of the inner needle from coming out of the proximal opening. It is designed to be removed from the outer needle unit.
  • the state in which the needle tip of the inner needle of the inner needle unit detached from the outer needle unit is held in the needle tip protector is maintained, so that the used needle tip can be used by doctors, nurses, disposal companies, etc. It is possible to prevent erroneous puncture.
  • the magnetic pole of the first magnet provided in the needle tip protector is directed so as to directly face the closing member in the axial direction across the inner needle (distal opening), the first magnet The magnetic force can be efficiently applied to the closing member, and the closing member can be reliably sucked when the inner needle is detached from the distal opening.
  • the diameter of the inner needle (distal opening) is increased, the occlusion member is enlarged and the separation distance from the first magnet is increased. There is a concern that it may be difficult to stably suck the blocking member.
  • the magnetic pole of the first magnet is directed so as to directly face the closing member in the direction perpendicular to the axis across the inner needle (distal opening). It is possible to stably perform attraction by the first magnet of the closing member even when the is large.
  • the second magnet provided on the outer needle cap is arranged so that the magnetic poles are arranged in the direction perpendicular to the axis in the same direction as the first magnet and located outside the first magnet. It is possible to stably attract the needle tip protector to the outer needle cap by effectively applying the attractive force of the two magnets to each other.
  • the magnetic poles of the first magnet and the second magnet are similarly arranged in the direction perpendicular to the axis, and the two magnets are arranged so as to overlap each other in the direction perpendicular to the axis.
  • the outer needle cap is provided with a fitting recess having a non-circular cross section that opens to the proximal end side. While the second magnet is disposed on the peripheral wall portion of the fitting recess, the distal end of the cylindrical portion of the needle tip protector projects with the same non-circular cross section as the fitting recess.
  • a fitting convex portion having an outer shape slightly smaller than the fitting concave portion is provided, and the outer needle cap and the needle tip protector are connected to the inner needle by fitting the fitting concave portion and the fitting convex portion.
  • the first magnet and the second magnet are arranged to face each other in the direction perpendicular to the axis.
  • the needle tip protector can be easily and reliably positioned with respect to the outer needle cap, and the fitting concave portion with the noncircular cross section is fitted.
  • the magnets can be positioned easily and reliably.
  • a third aspect of the present invention is the indwelling needle assembly according to the first or second aspect, wherein the closing member is made of a magnetic material.
  • the closing member unlike the case where the closing member is a magnet, the closing member does not need to be arranged with the same polarity, so that the closing member can be easily and reliably assembled.
  • the blocking member in the indwelling needle assembly according to any one of the first to third aspects, has a disk shape, and covers the distal opening. It has an outer diameter to obtain.
  • the closing member can be reliably and stably closed. Further, since the movement resistance is small, the closing member can be adsorbed with a weaker magnetic force. Therefore, even when the inner needle has a large diameter, that is, when the closing member that closes the distal side opening has a large diameter, it is possible to realize reliable protection of the needle tip without increasing the size of the magnet or the like. is there. In addition, since it is difficult to accurately control the polarity on the circumference of the closing member, it is desirable that the disk-shaped closing member is not a magnet but a magnetic body.
  • the magnetic pole of the first magnet provided on the needle tip protector is directed so as to directly face the closing member across the inner needle, and the first magnet provided on the outer needle cap. Since the two magnets are arranged so that the magnetic poles are arranged in the direction perpendicular to the axis in the same manner as the first magnet and are superimposed on the outside of the first magnet, Thus, it is possible to suck the closing member with a larger force while avoiding an increase in the number of parts and an increase in the size of the member.
  • FIG. 1 is an enlarged longitudinal sectional view of a needle tip protector portion of the indwelling needle assembly shown in FIG. 1.
  • FIG. 5 is an enlarged cross-sectional view of the closing member portion of the indwelling needle assembly shown in FIG. 1, corresponding to the VV cross section of FIG.
  • the medical staff side at the time of operation of the indwelling needle assembly is expressed as the proximal side
  • the patient side is expressed as the distal side.
  • FIGS. 1 and 2 are longitudinal sectional views of an indwelling needle assembly 10 having a structure according to the present invention.
  • the indwelling needle assembly 10 includes an inner needle unit 12 and an outer needle unit 14.
  • the inner needle unit 12 has an inner needle 18 having a sharp needle tip 16 at a distal end, an inner needle hub 20 attached to the proximal end of the inner needle 18, and moves in the needle axial direction with respect to the inner needle 18.
  • a needle tip protector 22 is provided that can be mounted.
  • the outer needle unit 14 includes an outer needle 24 through which the inner needle 18 can be inserted, an outer needle hub 26 that is attached to the proximal end of the outer needle 24 and through which the inner needle 18 can be inserted, and a proximity of the outer needle hub 26.
  • An outer needle cap 28 that covers the proximal end of the outer needle hub 26 and covers the inner needle 18 is detachably attached to the distal end.
  • the inner needle 18 is inserted into the outer needle cap 28 and the outer needle hub 26 and accommodated in the outer needle 24, and the inner needle unit 12 is brought into contact with the outer needle cap 28, whereby the inner needle unit 12 is contacted. 12 and the outer needle unit 14 are assembled together to form the indwelling needle assembly 10.
  • the inner needle 18 is a hollow needle and is formed of a known material such as stainless steel, aluminum, titanium, or an alloy thereof.
  • the needle tip 16 provided at the distal end of the inner needle 18 has a tapered shape whose outer diameter gradually decreases toward the tip, and can puncture a living body easily and with low stimulation.
  • the inner needle hub 20 attached to the proximal end of the inner needle 18 includes a substantially cylindrical pedestal portion 30 in which the proximal end of the inner needle 18 is fixed in an embedded state, and a distal end of the pedestal portion 30.
  • the substantially cylindrical protector accommodating portion 32 that protrudes and the substantially cylindrical cap coupling portion 34 that protrudes from the proximal end of the pedestal portion 30 are integrally formed of synthetic resin.
  • the proximal end of the inner needle 18 is exposed at the proximal end surface of the pedestal portion 30, and the lumen 96 of the inner needle 18 communicates with the internal space of the cap connecting portion 34.
  • an inner needle cap 36 is removably assembled to the opening of the cap connecting portion 34.
  • the inner needle cap 36 is a stepped cylindrical synthetic resin member provided with a step portion at an axially intermediate portion.
  • the opening on the small diameter side of the inner needle cap 36 is covered with a gas tight filter 38 in a liquid-tight manner. That is, the ventilation filter 38 has a property of allowing gas to pass through but blocking liquid.
  • a syringe or the like can be connected to the large-diameter side opening of the inner needle cap 36.
  • the opening part of the cap connection part 34 is liquid-tightly covered by assembling
  • the needle tip protector 22 of the inner needle unit 12 is composed of a stepped cylindrical synthetic resin member provided with a step portion at an axially intermediate portion, and includes a cylindrical portion 40 through which the inner needle 18 is inserted. ing.
  • the large-diameter side end which is the distal side of the tubular part 40 is provided with a fitting convex part 42 which protrudes in a substantially rounded non-circular cross section as shown in FIG.
  • a recess 44 is formed in the fitting convex portion 42, and the opening of the concave portion 44 is covered with a lid member 46, whereby a magnet housing space 48 is formed in the fitting convex portion 42. Yes.
  • Distal openings 52a and 52b through which the inner needle 18 is inserted are respectively penetrated through the bottom plate 50 and the lid member 46 of the recess 44.
  • a thin, substantially disk-shaped closing member 56 that is fixedly disposed and can be attracted to the first magnet 54 on the other side in the axial direction and can close the distal opening 52 is first. It is movably disposed on the magnet 54 side.
  • the N pole is set on the inner surface of the first magnet 54 in the direction perpendicular to the axis
  • the S pole is set on the outer surface.
  • a wall 58 that extends in the needle axis direction is provided at the small-diameter opening that is the proximal side of the tubular portion 40, and the proximal opening through which the inner needle 18 is inserted into the wall 58. The part 60 is penetrated.
  • the inner needle 18 is inserted through the proximal opening 60, the tubular portion 40, and the distal openings 52 a and 52 b in this order, so that the needle with respect to the inner needle 18 is inserted.
  • the tip protector 22 is mounted so as to be movable in the needle axis direction.
  • the needle tip protector 22 is accommodated and disposed in the protector accommodating portion 32 provided in the inner needle hub 20.
  • the needle tip protector 22 is moved to a position where the needle tip 16 of the inner needle 18 is accommodated in the cylindrical portion 40. .
  • the needle tip 16 of the inner needle 18 cannot be removed from the proximal opening 60 of the needle tip protector 22.
  • the outer needle 24 has a hollow needle shape, and preferably has an appropriate flexibility.
  • it can be composed of various soft resins such as ethylene-tetrafluoroethylene copolymer (ETFE), polyurethane, polyether nylon resin, and polypropylene.
  • ETFE ethylene-tetrafluoroethylene copolymer
  • the distal end 62 of the outer needle 24 is also tapered so that the outer diameter gradually decreases toward the tip.
  • the distal end 62 of the outer needle 24 may be provided with one or more through holes as required so that fluid can be efficiently distributed to the outer needle 24.
  • An outer needle hub 26 having a substantially cylindrical shape is fixed to the proximal end of the outer needle 24 in a liquid-tight manner, and the lumen 98 of the outer needle 24 and the inside of the outer needle hub 26 are communicated with each other.
  • a synthetic resin outer needle connector 68 having a substantially cylindrical shape is liquid-tightly fixed to a synthetic resin cylindrical body 64 provided on the distal side via an elastic tube 66. It is set as the structure.
  • a female luer taper 70 that allows connection to other medical devices is formed on the inner peripheral surface of the outer needle connector 68.
  • a male screw 72 is provided to ensure connection with other medical devices.
  • the outer needle connector 68 is not provided, and it is possible to connect to other medical devices using the flexibility of the elastic tube 66.
  • the outer needle cap 28 is attached to the proximal end of the outer needle connector 68 of the outer needle hub 26.
  • the outer needle cap 28 has a structure in which elastic packings 76a and 76b are disposed inside a cylindrical member 74 made of synthetic resin.
  • a tubular protrusion 78 is provided that is fluid-tightly connected to the female luer taper 70 of the outer needle connector 68.
  • a guide wall portion 80 is provided so as to surround the tubular protrusion 78, and a female screw 82 into which the male screw 72 of the outer needle connector 68 is screwed is formed inside the guide wall portion 80.
  • the opening on the proximal end side of the tubular projection 78 is covered with an elastic packing 76 in a liquid-tight manner.
  • the elastic packings 76a and 76b are respectively provided with slits 84a and 84b at the center portions, and the inner needle 18 can be passed through the slits 84a and 84b.
  • the opening of the tubular protrusion 78 is closed by the elastic packing 76, and the liquid can be prevented from flowing out from the proximal end of the outer needle unit 14.
  • the male thread 72 of the outer needle connector 68 is screwed to the female thread 82 of the guide wall 80 of the outer needle cap 28 while the tubular protrusion 78 of the outer needle cap 28 is connected to the female luer taper 70 of the outer needle connector 68.
  • the proximal end side opening of the outer needle connector 68 is covered with the outer needle cap 28 in a liquid-tight manner.
  • a fitting recess 86 is formed in the proximal end side of the cylindrical member 74 of the outer needle cap 28. As shown in FIGS. 5A and 5B, which will be described later, the fitting recess 86 has a substantially non-circular cross-sectional shape that is the same as the fitting protrusion 42 of the needle tip protector 22.
  • a second magnet 90 is fixedly disposed on the peripheral wall 88 that defines the planar inner peripheral surface of the fitting recess 86.
  • the second magnet 90 has the magnetic poles of the second magnet 90 arranged in the straight axis direction in the same manner as the first magnet 54.
  • the second magnet 90 is disposed on the outer side of the first magnet 54 in the axial direction.
  • the fitting convex portion 42 of the needle tip protector 22 is fitted to the fitting concave portion 86 of the outer needle cap 28, and the needle tip protector 22 is removed by the attractive force of the first magnet 54 and the second magnet 90.
  • the needle cap 28 is detachably adsorbed.
  • FIGS. 3 (a), 4 (a), and 5 (a) show the situation before using the indwelling needle assembly, which is equivalent to FIG.
  • the inner needle unit 12 is relatively pulled out from the outer needle unit 14 as shown in FIG.
  • the needle tip protector 22 is attracted to the outer needle cap 28 by the attractive force of the first magnet 54 and the second magnet 90, so that the inner needle 18 is pulled out.
  • the needle tip protector 22 adsorbed to the outer needle cap 28 moves to the distal side moving end in the needle axis direction.
  • the closing member 56 is attracted by the first and second magnets 54 and 90 to close the distal opening 52 (see FIG. 3 (c) FIG. 4 (b) and FIG. 5 (b)).
  • the needle tip 16 of the inner needle 18 is prevented from coming out of the proximal opening 60, so that the needle tip 16 of the inner needle 18 is accommodated inside the needle tip protector 22, and the inner needle unit 12 is disengaged from the outer needle unit 14 (states shown in FIGS. 3D, 4C, and 5C).
  • the inner needle unit 12 and the outer needle unit 14 are separated, and the inner needle unit 12 can be safely discarded in a state where the needle tip 16 of the inner needle 18 is accommodated in the needle tip protector 22. .
  • the inner needle 18 has a protruding portion 92 at a location moved proximally from the needle tip 16 by a predetermined distance.
  • the protrusion 92 has an outer diameter dimension in the needle axis direction that is larger than an inner diameter dimension of the proximal opening 60 of the needle tip protector 22 and smaller than an inner diameter dimension of the distal openings 52a and 52b. .
  • the needle tip 16 of the inner needle 18 can be accommodated inside the tubular portion 40 of the needle tip protector 22 through the distal openings 52b and 52a of the needle tip protector 22, while the needle tip protector.
  • the formation portion of the protrusion 92 in the inner needle 18 is formed when the protrusion 92 contacts the peripheral edge of the proximal opening 60 of the needle tip protector 22. Is set to be completely accommodated inside the cylindrical portion 40. Further, it is desirable to dispose a metal ring 94 having an inner diameter that is slightly larger than the outer diameter of the inner needle 18 and through which the protrusion 92 cannot be inserted, on the proximal side of the protrusion 92 of the inner needle 18. Thereby, the inner needle 18 can be further prevented from coming out of the proximal opening 60 of the needle tip protector 22.
  • the protrusion 92 and the metal ring 94 are not shown for the purpose of clarifying the drawing.
  • Such a protrusion 92 is, for example, with respect to a predetermined position of the inner needle 18 inserted through the proximal opening 60, the tubular portion 40, and the distal openings 52a and 52b of the needle tip protector 22 in this order. It can be provided by crushing or the like. Alternatively, the protrusion 92 can be provided by pressing a separate elastic ring at a predetermined position of the inner needle 18. Furthermore, a liquid absorber (not shown) that absorbs blood, body fluid, and the like may be provided in the internal space of the tubular portion 40 of the needle tip protector 22. Examples of the material of the liquid absorber include sponge, polyurethane, rubber-like elastic member, and the like.
  • the magnetic pole of the first magnet 54 provided on the cylindrical portion 40 of the needle tip protector 22 is In the direction perpendicular to the needle axis direction across the inner needle 18, it is directed so as to directly face the closing member 56.
  • the magnetic force of the first magnet 54 can be efficiently applied to the closing member 56, the diameter of the inner needle 18 is increased as in the indwelling needle assembly 10 used for, for example, artificial dialysis treatment, and the closing member 56 is Even when the distance between the first magnet 54 and the closing member 56 increases as the size increases, the closing member 56 is reliably sucked when the inner needle 18 is detached from the distal opening 52, and the inner needle 18 is Re-protrusion from the distal opening 52 of the needle tip protector 22 can be reliably prevented.
  • the second magnet 90 provided on the outer needle cap 28 is arranged so that the magnetic poles are arranged in the direction perpendicular to the axis in the same direction as the first magnet 54 and located outside the first magnet 54.
  • the suction force of the one magnet 54 and the second magnet 90 can be effectively applied to each other, and the needle tip protector 22 can be reliably attracted to the outer needle cap 28. Furthermore, since the magnetic poles of the first magnet 54 and the second magnet 90 are similarly arranged in the direction perpendicular to the axis and the magnets 54 and 90 are arranged so as to overlap each other in the direction perpendicular to the axis, the necessary arrangement of the magnets can be changed. By devising well, the closing member 56 can be attracted with a larger magnetic force while avoiding an increase in the number of parts and an increase in the size of the magnet of the member.
  • the material of the magnet used for the closing member 56, the first magnet 54, and the second magnet 90 is not particularly limited, and examples include a Samakova magnet, an Alnico magnet, a neodymium magnet, and a ferrite magnet.
  • the closing member 56 is preferably made of a magnetic material because of the ease of positioning with respect to the first magnet 54 and the second magnet 90.
  • the material of the magnetic material used for the closing member 56 is not particularly limited as long as the magnet can adsorb, but a magnetic material such as stainless steel having good rust resistance is preferable.
  • the shape of the closing member 56 is not particularly limited as long as it is a shape that can close the distal side opening 52 of the tubular portion 40 of the needle tip protector 22 after the inner needle 18 is removed. Thus, a thin disk shape is preferable. Since the circular closure member 56 has no corners on the outer peripheral surface, it can be smoothly moved by being prevented from being caught on the inner surface of the magnet housing space 48 when attracted to the first magnet 54. It is.
  • the fitting concave portion 86 of the outer needle cap 28 has a substantially semicircular non-circular cross section, while the fitting convex portion 42 of the needle tip protector 22 is the same as the fitting concave portion 86. And has an outer shape slightly smaller than the fitting recess 86.
  • the outer needle cap 28 and the needle tip protector 22 are highly positioned around the needle axis of the inner needle 18 only by fitting the fitting concave portion 86 and the fitting convex portion 42. Therefore, the first magnet 54 and the second magnet 90 can be reliably arranged to face each other in the axial direction, and a desired attraction force by the first magnet 54 and the second magnet 90 can be obtained with certainty.
  • the fitting recess 86 of the outer needle cap 28 a space for accommodating the second magnet 90 is ensured by skillfully utilizing the thick peripheral wall portion 88 to define the planar inner peripheral surface. Yes. Accordingly, the first magnet 54 and the second magnet 90 can be arranged opposite to each other in the axial direction without increasing the overall size of the indwelling needle assembly, and a large magnetic force can be exerted on the closing member 56. is there.
  • the first magnet and the second magnet need only be arranged opposite to each other so that the magnetic poles are similarly arranged in the direction perpendicular to the needle axis, and the arrangement of the N pole and the S pole is opposite to that of the embodiment. Needless to say, the same effects can be obtained even if they are arranged.
  • the fitting concave portion 86 of the outer needle cap 28 and the fitting convex portion 42 of the needle tip protector 22 are not limited to specific shapes as long as they are configured with a non-circular cross section that can be easily positioned in the circumferential direction.
  • a rectangular cross-section, a polygonal cross-section, or the like may be used.
  • an uneven engagement portion may be provided between the overlapping surfaces of the fitting concave portion 86 of the outer needle cap 28 and the fitting convex portion 42 of the needle tip protector 22 so as to further improve the positioning accuracy.
  • the distal opening 52 of the cylindrical portion 40 of the needle tip protector 22 is closed to fill the inner space of the cylindrical portion 40 of the needle tip protector 22 with the needle of the inner needle 18.
  • a conical recess may be formed in a portion where the needle tip 16 can come into contact.
  • the needle tip 16 pushes the blocking member 56 that closes the distal opening 52 of the tubular portion 40 of the needle tip protector 22 and moves distally. Protruding from the side opening 52 or protruding from a place other than the distal opening 52 can be prevented.
  • 10 Indwelling needle assembly
  • 12 Inner needle unit
  • 14 Outer needle unit
  • 16 Needle tip
  • 18 Inner needle
  • 20 Inner needle hub
  • 22 Needle tip protector
  • 24 Outer needle
  • 26 Outer needle Hub: 28: outer needle cap
  • 40 cylindrical portion
  • 42 fitting convex portion
  • 52 distal opening
  • 54 first magnet
  • 56 occlusion member
  • 60 proximal opening
  • 86 Fitting recess
  • 88 peripheral wall
  • 90 second magnet

Abstract

Provided is an indwelling needle assembly that has a novel structure, is able to stably achieve protection of a needle tip by means of a needle tip protector, and reliably performs adhesion to the magnet of an occlusion member without an accompanying enlargement of the magnet, an outer needle unit, or an inner needle unit, even if the inner needle has a large gauge. The indwelling needle assembly (10) results from being provided with an outer needle unit (14) and an inner needle unit (12) having a needle tip protector (22), and in the needle tip protector (22), sandwiching a distal aperture (52), a first magnet (54) of which the magnetic poles are aligned in a perpendicular-axis direction perpendicular to the direction of the needle shaft is disposed in an affixed manner at one side in the perpendicular-axis direction, while an occlusion member (56) that can occlude the distal aperture (52) by being able to be drawn towards the first magnet (54) is disposed at the other side in the perpendicular-axis direction and in a manner so as to be able to move to the side of the first magnet (54). Furthermore, a second magnet (90) is disposed in the outer needle cap (28) of the outer needle unit (14), the magnetic poles of the second magnet (90) are aligned similarly to the first magnet (54) in the perpendicular-axis direction, and the second magnet (90) is provided to the outside of the first magnet (54) in the perpendicular-axis direction.

Description

留置針組立体Indwelling needle assembly
 本発明は、輸液や採血、血液透析等を行う際に、血管に穿刺されて留置される留置針組立体に係り、特に、使用後の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に関するものである。 The present invention relates to an indwelling needle assembly that is punctured and placed in a blood vessel when performing infusion, blood collection, hemodialysis, and the like, and in particular, includes a needle tip protector that protects the needle tip of an inner needle after use. The present invention relates to an indwelling needle assembly.
 従来から、外針ユニットの外針を貫通して内針ユニットの内針を組み付けた留置針組立体が知られている。この留置針組立体は、輸液や採血、血液透析等を行うに際して、患者の血管に穿刺した後、内針を含む内針ユニットを外針を含む外針ユニットから取り外すことにより、外針を患者の血管に留置させて治療に使用するものである。 Conventionally, an indwelling needle assembly in which an outer needle of an outer needle unit is passed through and an inner needle of an inner needle unit is assembled is known. When performing infusion, blood collection, hemodialysis, etc., the indwelling needle assembly punctures a patient's blood vessel, and then removes the inner needle unit including the inner needle from the outer needle unit including the outer needle, thereby removing the outer needle from the patient. It is used for treatment by placing it in the blood vessel.
 ところで、患者の血管への穿刺後に、外針ユニットから取り外した内針ユニットの内針は、その遠位端に鋭利な針先を有しており、かかる針先が医者や看護婦、廃棄業者等に誤って穿刺される誤穿刺事故が発生するおそれがある。このような誤穿刺事故は、針先に付着した血液等からエイズやウイルス等の感染を引き起こすおそれがあり、未然に防止することが重要となる。 By the way, the inner needle of the inner needle unit removed from the outer needle unit after puncturing the patient's blood vessel has a sharp needle tip at its distal end, and this needle tip is a doctor, nurse, or waste disposal company. There is a risk that an accidental puncture accident may occur. Such an erroneous puncture accident may cause infection such as AIDS or virus from blood or the like adhering to the needle tip, and it is important to prevent it beforehand.
 そこで、外針から内針を引き抜く際に、内針ユニットに備えたスライド式のカバーが伸長して内針全体が収容されるようにしたプロテクタを備えた留置針組立体が提案されている。例えば特許第3400550号公報(特許文献1)特開平7-148270号公報(特許文献2)に記載のものがそれである。また、特開2002-102345号公報(特許文献3)には、ばね式の針先プロテクタが外針ユニットに配設されており、内針を引き抜くことにより外針ユニットから針先プロテクタが離脱して針先を覆うようにしたものが提案されている。 Therefore, an indwelling needle assembly including a protector has been proposed in which when the inner needle is pulled out from the outer needle, a slide-type cover provided in the inner needle unit is extended to accommodate the entire inner needle. For example, the one described in Japanese Patent No. 3400550 (Patent Document 1) and Japanese Patent Laid-Open No. 7-148270 (Patent Document 2). In Japanese Patent Laid-Open No. 2002-102345 (Patent Document 3), a spring-type needle tip protector is disposed in the outer needle unit, and the needle tip protector is detached from the outer needle unit by pulling out the inner needle. It has been proposed to cover the needle tip.
 ところが、このような従来構造のプロテクタを備えた留置針組立体では、プロテクタが内針全体を覆う構造とされていることから、留置針組立体自体の大型化が避けられないという問題があった。またばね式の針先プロテクタの場合、内針を引き抜く際にばねの付勢力が加えられ、内針の引き抜きに際して大きな力が必要になるという問題もあった。また、内針の針先がプロテクタから再突出するおそれもあった。 However, in the indwelling needle assembly provided with the protector having such a conventional structure, since the protector is structured to cover the entire inner needle, there is a problem that the indwelling needle assembly itself cannot be increased in size. . Further, in the case of a spring-type needle tip protector, there is a problem that a biasing force of the spring is applied when the inner needle is pulled out, and a large force is required when the inner needle is pulled out. In addition, the tip of the inner needle may re-project from the protector.
 これに対して、本願出願人は、特許4661240号公報(特許文献4)において、内針にスライド自在に装着された針先のみを収容し得る針先プロテクタを備え、かかる針先プロテクタの近位端は内針から離脱不能とされている一方、針先プロテクタの遠位側の開口部には、内針の針先が開口部から針先プロテクタの内部に収容された際に、磁石に対して磁性材や磁石からなる覆蓋部材を吸着させて針先プロテクタの遠位側開口部を閉塞するようにした構造を提案した。このような構造によれば、針先のみを収容する小型の針先プロテクタによって針先が保護されることから、留置針組立体の大型化を回避することができる。また、内針を引き抜く際にばねの付勢力が及ぼされないことから、内針の引き抜き力が大きくなることを回避できる。さらに、針先プロテクタの遠位側開口部が磁力により吸着される閉塞部材によって閉塞されることから、閉塞部材を安定して閉位置に保持することができ、再度開口部が開口することを確実に防止できる画期的なものであった。そして、本願出願人は、先に提案した構造の留置針組立体において、内針が大径になる場合でも、磁石等の大型化を招くことなく確実な針先の保護を高度に実現し得る更なる改良構造について検討を重ねていた。 On the other hand, the applicant of the present application, in Japanese Patent No. 4661240 (Patent Document 4), includes a needle tip protector that can accommodate only a needle tip that is slidably attached to the inner needle, and is proximal to the needle tip protector. While the end is not removable from the inner needle, the distal end opening of the needle tip protector is positioned against the magnet when the needle tip of the inner needle is housed in the needle tip protector from the opening. A structure has been proposed in which a cover member made of a magnetic material or magnet is adsorbed to close the distal opening of the needle tip protector. According to such a structure, since the needle tip is protected by the small needle tip protector that accommodates only the needle tip, an increase in the size of the indwelling needle assembly can be avoided. Further, since the biasing force of the spring is not exerted when the inner needle is pulled out, it is possible to avoid an increase in the pulling force of the inner needle. Furthermore, since the distal side opening of the needle tip protector is closed by the closing member attracted by the magnetic force, the closing member can be stably held in the closed position, and the opening is surely opened again. It was a breakthrough that could be prevented. Further, the applicant of the present application can realize highly reliable protection of the needle tip without causing an increase in the size of the magnet or the like even when the inner needle has a large diameter in the indwelling needle assembly having the previously proposed structure. We have been studying further improved structures.
特許第3400550号公報Japanese Patent No. 3400550 特開平7-148270号公報JP 7-148270 A 特開2002-102345号公報JP 2002-102345 A 特許4661240号公報Japanese Patent No. 4661240
 本発明は、上述の事情を背景に為されたものであって、その解決課題は、内針が大径となる場合でも、磁石や外針ユニットおよび内針ユニットの大型化を伴うことなく、閉塞部材の磁石への吸着を確実に行い、針先プロテクタによる針先の保護を安定して実現し得る、新規な構造の留置針組立体を提供することにある。 The present invention has been made in the background of the above-mentioned circumstances, and the problem to be solved is that, even when the inner needle has a large diameter, without enlarging the magnet, the outer needle unit, and the inner needle unit, It is an object of the present invention to provide an indwelling needle assembly having a novel structure capable of reliably adsorbing a closing member to a magnet and stably realizing protection of the needle tip by a needle tip protector.
 すなわち、本発明の第1の態様は、遠位端に針先を有する内針と、該内針の近位端に取り付けられた内針ハブと、該内針に対して針軸方向に移動可能に装着された針先プロテクタを備えた内針ユニットと、前記内針が挿通可能な外針と、該外針の近位端に取り付けられて該内針が挿通可能な外針ハブと、該外針ハブの近位端に着脱可能に取り付けられて該内針が挿通可能であると共に前記外針ハブの近位端を覆蓋する外針キャップを備えた外針ユニットとを含み、前記内針が前記外針キャップおよび前記外針ハブに挿通されて前記外針の内部に収容配置されると共に、該外針キャップに前記内針ユニットが当接されることにより前記内針ユニットと前記外針ユニットが互いに組み付けられてなる留置針組立体において、前記内針ユニットの前記針先プロテクタは、前記内針が挿通配置された筒状部を備え、該筒状部の遠位側には、該内針が挿通された遠位側開口部が形成されていると共に、該遠位側開口部を挟んで前記針軸方向に直交する軸直方向の一方の側に該軸直方向で磁極が配列された第一磁石が固定的に配設されている一方、該軸直方向の他方の側に該第一磁石に吸引可能とされて該遠位側開口部を閉塞可能な閉塞部材が該第一磁石側に移動可能に配設されており、且つ該筒状部の近位側には、該内針が挿通された近位側開口部が形成されていると共に、該内針の前記針先が該近位側開口部から抜け出し不能に組み付けられている一方、前記外針ユニットの前記外針キャップには第二磁石が配設されており、該外針ユニットと前記内針ユニットの組み付け状態において、前記第二磁石の磁極が前記軸直方向で前記第一磁石と同様に配列されていると共に、該軸直方向において該第一磁石の外方側に該第二磁石が配設されるようになっており、該第一磁石と該第二磁石の吸引力により前記針先プロテクタが前記外針キャップに離脱可能に吸着されていることを特徴とする留置針組立体を提供するものである。 That is, the first aspect of the present invention includes an inner needle having a needle tip at a distal end, an inner needle hub attached to the proximal end of the inner needle, and movement in the needle axis direction with respect to the inner needle. An inner needle unit having a needle tip protector attached thereto, an outer needle through which the inner needle can be inserted, an outer needle hub attached to the proximal end of the outer needle and through which the inner needle can be inserted; An outer needle unit that is detachably attached to the proximal end of the outer needle hub and through which the inner needle can be inserted and has an outer needle cap that covers the proximal end of the outer needle hub. A needle is inserted into the outer needle cap and the outer needle hub and accommodated in the outer needle, and the inner needle unit is brought into contact with the outer needle cap by contacting the inner needle unit with the outer needle cap. In the indwelling needle assembly in which the needle units are assembled to each other, the inner needle unit The needle tip protector includes a cylindrical portion through which the inner needle is inserted, and a distal side opening through which the inner needle is inserted is formed on the distal side of the cylindrical portion. A first magnet having magnetic poles arranged in a direction perpendicular to the axis is fixedly disposed on one side of the direction perpendicular to the axis of the needle across the distal opening. A closing member that can be attracted to the first magnet and can close the distal opening is disposed on the other side in the straight direction so as to be movable toward the first magnet, and the cylindrical portion. A proximal opening through which the inner needle is inserted is formed on the proximal side of the inner needle, and the needle tip of the inner needle is assembled so as not to come out of the proximal opening. A second magnet is disposed on the outer needle cap of the outer needle unit, and in an assembled state of the outer needle unit and the inner needle unit, The magnetic poles of the second magnet are arranged in the axial direction in the same manner as the first magnet, and the second magnet is arranged on the outer side of the first magnet in the axial direction. The indwelling needle assembly is characterized in that the needle tip protector is detachably attracted to the outer needle cap by the attractive force of the first magnet and the second magnet.
 本態様によれば、前記外針ユニットから前記内針ユニットを引き抜くに際して、前記内針の引き抜き方向への移動に伴い前記外針キャップに吸着された前記針先プロテクタが前記針軸方向の遠位側移動端に移動して、前記筒状部の前記遠位側開口部から該内針が離脱すると共に前記閉塞部材が第一および第二磁石に吸引されて該遠位側開口部が閉塞される。また、内針の針先が前記近位側開口部からの抜け出しが阻止されることにより前記針先が前記針先プロテクタの筒状部の内部に収容された状態で、該内針ユニットが該外針ユニットから離脱されるようになっている。 According to this aspect, when the inner needle unit is pulled out from the outer needle unit, the needle tip protector adsorbed to the outer needle cap as the inner needle moves in the pulling direction is moved distally in the needle axis direction. The inner needle is detached from the distal opening of the cylindrical portion, and the closing member is attracted by the first and second magnets to close the distal opening. The Further, the inner needle unit is in a state where the needle tip is housed inside the cylindrical portion of the needle tip protector by preventing the needle tip of the inner needle from coming out of the proximal opening. It is designed to be removed from the outer needle unit.
 これにより、外針ユニットから離脱された内針ユニットの内針の針先が針先プロテクタに収容された状態が保持されることから、使用後の針先が医師や看護師、廃棄業者等に誤穿刺されることを未然に防止することができる。 As a result, the state in which the needle tip of the inner needle of the inner needle unit detached from the outer needle unit is held in the needle tip protector is maintained, so that the used needle tip can be used by doctors, nurses, disposal companies, etc. It is possible to prevent erroneous puncture.
 特に、針先プロテクタに設けられた第一磁石の磁極が、内針(遠位側開口部)を挟んだ軸直方向において閉塞部材に直接対向するように向けられていることから、第一磁石の磁力を効率的に閉塞部材に及ぼすことができて、内針が遠位側開口部から離脱した際の閉塞部材の吸引を確実に行うことができる。例えば、人工透析治療等に用いる留置針組立体の場合、内針(遠位側開口部)の径が大きくなり、閉塞部材が大型化すると共に第一磁石との離隔距離が大きくなることから、安定した閉塞部材の吸引が困難となる場合が懸念される。しかしながら、本態様によれば、第一磁石の磁極が、内針(遠位側開口部)を挟んだ軸直方向において閉塞部材に直接対向するように向けられていることにより、内針の径が大きい場合でも閉塞部材の第一磁石による吸引を安定して行うことが可能となる。 In particular, since the magnetic pole of the first magnet provided in the needle tip protector is directed so as to directly face the closing member in the axial direction across the inner needle (distal opening), the first magnet The magnetic force can be efficiently applied to the closing member, and the closing member can be reliably sucked when the inner needle is detached from the distal opening. For example, in the case of an indwelling needle assembly used for artificial dialysis treatment, etc., the diameter of the inner needle (distal opening) is increased, the occlusion member is enlarged and the separation distance from the first magnet is increased. There is a concern that it may be difficult to stably suck the blocking member. However, according to this aspect, the magnetic pole of the first magnet is directed so as to directly face the closing member in the direction perpendicular to the axis across the inner needle (distal opening). It is possible to stably perform attraction by the first magnet of the closing member even when the is large.
 さらに、外針キャップに設けた第二磁石を、軸直方向で第一磁石と同様に磁極を配列すると共に第一磁石の外方に位置するように配設することにより、第一磁石と第二磁石の吸引力を相互に効率的に及ぼして外針キャップに針先プロテクタを安定して吸着することができる。 Further, the second magnet provided on the outer needle cap is arranged so that the magnetic poles are arranged in the direction perpendicular to the axis in the same direction as the first magnet and located outside the first magnet. It is possible to stably attract the needle tip protector to the outer needle cap by effectively applying the attractive force of the two magnets to each other.
 特に、第一磁石と第二磁石の磁極を軸直方向で同様に配列して且つ軸直方向で両磁石を重ね合わせるように配設したことから、必要な磁石の配列をうまく工夫することにより、部品点数の増大や部材の大型化を回避しつつ、閉塞部材をより大きな力で吸引することができるのである。 In particular, the magnetic poles of the first magnet and the second magnet are similarly arranged in the direction perpendicular to the axis, and the two magnets are arranged so as to overlap each other in the direction perpendicular to the axis. Thus, it is possible to suck the closing member with a larger force while avoiding an increase in the number of parts and an increase in the size of the member.
 本発明の第2の態様は、前記第1の態様に記載の留置針組立体において、前記外針キャップには、近位端側に開口する非円形断面の嵌合凹部が設けられていると共に該嵌合凹部の周壁部に前記第二磁石が配設されている一方、前記針先プロテクタの前記筒状部の遠位端には、該嵌合凹部と同一の非円形断面で突出すると共に該嵌合凹部よりもわずかに小さな外形形状を有する嵌合凸部が設けられており、前記嵌合凹部と前記嵌合凸部の嵌合により前記外針キャップと前記針先プロテクタが前記内針の針軸周りで位置決めされていると共に、前記第一磁石と前記第二磁石が前記軸直方向で対向配置されるようになっているものである。 According to a second aspect of the present invention, in the indwelling needle assembly according to the first aspect, the outer needle cap is provided with a fitting recess having a non-circular cross section that opens to the proximal end side. While the second magnet is disposed on the peripheral wall portion of the fitting recess, the distal end of the cylindrical portion of the needle tip protector projects with the same non-circular cross section as the fitting recess. A fitting convex portion having an outer shape slightly smaller than the fitting concave portion is provided, and the outer needle cap and the needle tip protector are connected to the inner needle by fitting the fitting concave portion and the fitting convex portion. And the first magnet and the second magnet are arranged to face each other in the direction perpendicular to the axis.
 本態様によれば、非円形断面の嵌合凹部と嵌合凸部を設けることにより、外針キャップに対する針先プロテクタの位置決めが容易かつ確実に行い得ると共に、非円形断面の嵌合凹部と嵌合凸部の周壁部に第一および第二の磁石を配設するだけで、それら磁石の位置決めも容易且つ確実に行うことができる。 According to this aspect, by providing the fitting concave portion and the fitting convex portion with the noncircular cross section, the needle tip protector can be easily and reliably positioned with respect to the outer needle cap, and the fitting concave portion with the noncircular cross section is fitted. By simply disposing the first and second magnets on the peripheral wall portion of the joint convex portion, the magnets can be positioned easily and reliably.
 本発明の第3の態様は、前記第1又は第2の態様に記載の留置針組立体において、前記閉塞部材が磁性体で形成されているものである。 A third aspect of the present invention is the indwelling needle assembly according to the first or second aspect, wherein the closing member is made of a magnetic material.
 本態様によれば、閉塞部材が磁石の場合と異なり極性を合わせて配設する必要がないため、閉塞部材の組み付けを容易且つ確実に行うことができる。 According to this aspect, unlike the case where the closing member is a magnet, the closing member does not need to be arranged with the same polarity, so that the closing member can be easily and reliably assembled.
 本発明の第4の態様は、前記第1乃至第3の何れか一つの態様に記載の留置針組立体において、前記閉塞部材が円盤形状とされており、前記遠位側開口部を覆蓋し得る外径を有しているものである。 According to a fourth aspect of the present invention, in the indwelling needle assembly according to any one of the first to third aspects, the blocking member has a disk shape, and covers the distal opening. It has an outer diameter to obtain.
 本態様によれば、閉塞部材の全周に亘って角部がなく閉塞時の移動抵抗をより少なくすることができることから、閉塞部材の閉塞を確実且つ安定して行うことができる。また、移動抵抗が小さいことにより、より弱い磁力で閉塞部材を吸着することができる。それ故、内針が大径になる場合すなわち前記遠位側開口部を塞ぐ閉塞部材が大径になる場合でも、磁石等の大型化を招くことなく確実な針先の保護を実現し得るのである。なお、閉塞部材の円周上に極性を精度よく制御して形成することが困難であることから、円盤形状の閉塞部材は磁石ではなく磁性体であることが望ましい。 According to this aspect, since there is no corner portion over the entire circumference of the closing member and the movement resistance at the closing time can be further reduced, the closing member can be reliably and stably closed. Further, since the movement resistance is small, the closing member can be adsorbed with a weaker magnetic force. Therefore, even when the inner needle has a large diameter, that is, when the closing member that closes the distal side opening has a large diameter, it is possible to realize reliable protection of the needle tip without increasing the size of the magnet or the like. is there. In addition, since it is difficult to accurately control the polarity on the circumference of the closing member, it is desirable that the disk-shaped closing member is not a magnet but a magnetic body.
 本発明の留置針組立体においては、針先プロテクタに設けられた第一磁石の磁極が、内針を挟んで閉塞部材に直接対向するように向けられていると共に、外針キャップに設けた第二磁石が、軸直方向で第一磁石と同様に磁極が配列されて且つ第一磁石の外方に重ね合わせるように配設されていることから、必要な磁石の配列をうまく工夫することにより、部品点数の増大や部材の大型化を回避しつつ、閉塞部材をより大きな力で吸引することができるのである。 In the indwelling needle assembly of the present invention, the magnetic pole of the first magnet provided on the needle tip protector is directed so as to directly face the closing member across the inner needle, and the first magnet provided on the outer needle cap. Since the two magnets are arranged so that the magnetic poles are arranged in the direction perpendicular to the axis in the same manner as the first magnet and are superimposed on the outside of the first magnet, Thus, it is possible to suck the closing member with a larger force while avoiding an increase in the number of parts and an increase in the size of the member.
本発明の第1の実施形態としての留置針組立体の使用前の状態を示す縦断面図。The longitudinal cross-sectional view which shows the state before use of the indwelling needle assembly as a 1st Embodiment of this invention. 図1に示した留置針組立体の内針ユニットの引き抜き後の状態を示す縦断面図。The longitudinal cross-sectional view which shows the state after extraction of the inner needle unit of the indwelling needle assembly shown in FIG. 図1および図2に示した留置針組立体の使用時の工程を示す説明図。Explanatory drawing which shows the process at the time of use of the indwelling needle assembly shown to FIG. 1 and FIG. 図1に示した留置針組立体の針先プロテクタ部の拡大縦断面図。FIG. 2 is an enlarged longitudinal sectional view of a needle tip protector portion of the indwelling needle assembly shown in FIG. 1. 図1に示した留置針組立体の閉塞部材部の拡大横断面図であり、図4のV-V断面に相当する図。FIG. 5 is an enlarged cross-sectional view of the closing member portion of the indwelling needle assembly shown in FIG. 1, corresponding to the VV cross section of FIG.
 以下、本発明を更に具体的に明らかにするために、本発明の実施形態について、図面を参照しつつ、詳細に説明する。以下の説明において、留置針組立体操作時における医療従事者側を近位側、患者側を遠位側と表現することにする。 Hereinafter, in order to clarify the present invention more specifically, embodiments of the present invention will be described in detail with reference to the drawings. In the following description, the medical staff side at the time of operation of the indwelling needle assembly is expressed as the proximal side, and the patient side is expressed as the distal side.
 先ず、図1及び図2は、本発明に従う構造とされた留置針組立体10の縦断面図が示されている。図1及び図2に示すように、留置針組立体10は、内針ユニット12と外針ユニット14より構成されている。内針ユニット12は、遠位端に鋭利な針先16を有する内針18と、内針18の近位端に取り付けられた内針ハブ20と、内針18に対して針軸方向に移動可能に装着された針先プロテクタ22を備えている。一方、外針ユニット14は、内針18が挿通可能な外針24と、外針24の近位端に取り付けられて内針18が挿通可能な外針ハブ26と、外針ハブ26の近位端に着脱可能に取り付けられて内針18が挿通可能であると共に外針ハブ26の近位端を覆蓋する外針キャップ28を備えている。そして、内針18が外針キャップ28および外針ハブ26に挿通されて外針24の内部に収容配置されると共に、外針キャップ28に内針ユニット12が当接されることにより内針ユニット12と外針ユニット14が互いに組み付けられて、留置針組立体10が形成されている。 First, FIGS. 1 and 2 are longitudinal sectional views of an indwelling needle assembly 10 having a structure according to the present invention. As shown in FIGS. 1 and 2, the indwelling needle assembly 10 includes an inner needle unit 12 and an outer needle unit 14. The inner needle unit 12 has an inner needle 18 having a sharp needle tip 16 at a distal end, an inner needle hub 20 attached to the proximal end of the inner needle 18, and moves in the needle axial direction with respect to the inner needle 18. A needle tip protector 22 is provided that can be mounted. On the other hand, the outer needle unit 14 includes an outer needle 24 through which the inner needle 18 can be inserted, an outer needle hub 26 that is attached to the proximal end of the outer needle 24 and through which the inner needle 18 can be inserted, and a proximity of the outer needle hub 26. An outer needle cap 28 that covers the proximal end of the outer needle hub 26 and covers the inner needle 18 is detachably attached to the distal end. The inner needle 18 is inserted into the outer needle cap 28 and the outer needle hub 26 and accommodated in the outer needle 24, and the inner needle unit 12 is brought into contact with the outer needle cap 28, whereby the inner needle unit 12 is contacted. 12 and the outer needle unit 14 are assembled together to form the indwelling needle assembly 10.
 内針ユニット12において、内針18は中空針であり、ステンレス鋼、アルミニウム、チタン又はそれらの合金等の公知の材料から形成されている。内針18の遠位端に設けられた針先16は、外径が先端に向かって漸減するテーパ状とされており、生体への穿刺が容易且つ低刺激で行い得るようになっている。一方、内針18の近位端に取り付けられた内針ハブ20は、内針18の近位端が埋設状態で固定された略円柱形状の台座部30と、台座部30の遠位端から突出する略円筒形状のプロテクタ収容部32と、台座部30の近位端から突出する略円筒形状のキャップ連結部34が、合成樹脂により一体成形された構造とされている。なお、内針18の近位端が台座部30の近位側端面に露出されており、内針18の内腔96がキャップ連結部34の内部空間と連通されている。 In the inner needle unit 12, the inner needle 18 is a hollow needle and is formed of a known material such as stainless steel, aluminum, titanium, or an alloy thereof. The needle tip 16 provided at the distal end of the inner needle 18 has a tapered shape whose outer diameter gradually decreases toward the tip, and can puncture a living body easily and with low stimulation. On the other hand, the inner needle hub 20 attached to the proximal end of the inner needle 18 includes a substantially cylindrical pedestal portion 30 in which the proximal end of the inner needle 18 is fixed in an embedded state, and a distal end of the pedestal portion 30. The substantially cylindrical protector accommodating portion 32 that protrudes and the substantially cylindrical cap coupling portion 34 that protrudes from the proximal end of the pedestal portion 30 are integrally formed of synthetic resin. The proximal end of the inner needle 18 is exposed at the proximal end surface of the pedestal portion 30, and the lumen 96 of the inner needle 18 communicates with the internal space of the cap connecting portion 34.
 さらに、キャップ連結部34の開口部には、内針キャップ36が離脱可能に組み付けられている。内針キャップ36は、軸方向中間部分に段差部が設けられた段付円筒形状の合成樹脂部材とされている。内針キャップ36の小径側の開口部は、通気フィルタ38により液密に覆蓋されている。すなわち、通気フィルタ38は、気体は透過するが液体は遮断する性質を持ち合わせるものである。また、内針キャップ36の大径側開口部には、シリンジ等が連結可能とされている。そして、キャップ連結部34の開口部に対して、内針キャップ36の小径側端部を密着状態で組み付けることにより、キャップ連結部34の開口部が液密に覆蓋されるようになっている。 Furthermore, an inner needle cap 36 is removably assembled to the opening of the cap connecting portion 34. The inner needle cap 36 is a stepped cylindrical synthetic resin member provided with a step portion at an axially intermediate portion. The opening on the small diameter side of the inner needle cap 36 is covered with a gas tight filter 38 in a liquid-tight manner. That is, the ventilation filter 38 has a property of allowing gas to pass through but blocking liquid. A syringe or the like can be connected to the large-diameter side opening of the inner needle cap 36. And the opening part of the cap connection part 34 is liquid-tightly covered by assembling | attaching the small diameter side edge part of the inner needle cap 36 with respect to the opening part of the cap connection part 34 in close contact.
 内針ユニット12の針先プロテクタ22は、軸方向中間部分に段差部が設けられた段付き円筒形状の合成樹脂部材により構成されており、内針18が挿通配置される筒状部40を備えている。筒状部40の遠位側となる大径側端部には、後述する図5(c)に示すように略かまぼこ状の非円形断面で突出する嵌合凸部42が設けられている。この嵌合凸部42には凹所44が形成されており、該凹所44の開口部が蓋部材46で覆蓋されることにより、嵌合凸部42内に磁石収容空間48が形成されている。凹所44の底板50と蓋部材46には、それぞれ内針18が挿通される遠位側開口部52a,52bが貫設されている。そして、磁石収容空間48の内部には、遠位側開口部52a,52bを挟んで針軸方向に直交する軸直方向の一方の側に軸直方向で磁極が配列された第一磁石54が固定的に配設されている一方、軸直方向の他方の側に第一磁石54に吸引可能とされて遠位側開口部52を閉塞可能な薄肉の略円盤形状の閉塞部材56が第一磁石54側に移動可能に配設されている。なお、本実施形態では、第一磁石54の軸直方向の内方面にN極が外方面にS極が設定されている。さらに、筒状部40の近位側となる小径側開口部には、針軸方向に広がる壁部58が設けられており、壁部58に対して内針18が挿通される近位側開口部60が貫設されている。 The needle tip protector 22 of the inner needle unit 12 is composed of a stepped cylindrical synthetic resin member provided with a step portion at an axially intermediate portion, and includes a cylindrical portion 40 through which the inner needle 18 is inserted. ing. The large-diameter side end which is the distal side of the tubular part 40 is provided with a fitting convex part 42 which protrudes in a substantially rounded non-circular cross section as shown in FIG. A recess 44 is formed in the fitting convex portion 42, and the opening of the concave portion 44 is covered with a lid member 46, whereby a magnet housing space 48 is formed in the fitting convex portion 42. Yes. Distal openings 52a and 52b through which the inner needle 18 is inserted are respectively penetrated through the bottom plate 50 and the lid member 46 of the recess 44. In the magnet housing space 48, a first magnet 54 in which magnetic poles are arranged in the axial direction on one side of the axial direction orthogonal to the needle axis direction across the distal openings 52a and 52b. A thin, substantially disk-shaped closing member 56 that is fixedly disposed and can be attracted to the first magnet 54 on the other side in the axial direction and can close the distal opening 52 is first. It is movably disposed on the magnet 54 side. In the present embodiment, the N pole is set on the inner surface of the first magnet 54 in the direction perpendicular to the axis, and the S pole is set on the outer surface. Furthermore, a wall 58 that extends in the needle axis direction is provided at the small-diameter opening that is the proximal side of the tubular portion 40, and the proximal opening through which the inner needle 18 is inserted into the wall 58. The part 60 is penetrated.
 このような針先プロテクタ22に対して、内針18が近位側開口部60、筒状部40、遠位側開口部52a,52bの順に挿通されることで、内針18に対して針先プロテクタ22が針軸方向に移動可能に装着される。そして、図1に示す内針ユニット12と外針ユニット14との組み付け状態では、針先プロテクタ22は内針ハブ20に設けられたプロテクタ収容部32に収容配置されることとなる。また、図2に示す内針ユニット12を外針ユニット14から引き抜いた状態では、針先プロテクタ22は、内針18の針先16が筒状部40の内部に収容される位置まで移動される。なお、後述するように、内針18の針先16は、針先プロテクタ22の近位側開口部60から抜け出し不能となっている。 With respect to such a needle tip protector 22, the inner needle 18 is inserted through the proximal opening 60, the tubular portion 40, and the distal openings 52 a and 52 b in this order, so that the needle with respect to the inner needle 18 is inserted. The tip protector 22 is mounted so as to be movable in the needle axis direction. In the assembled state of the inner needle unit 12 and the outer needle unit 14 shown in FIG. 1, the needle tip protector 22 is accommodated and disposed in the protector accommodating portion 32 provided in the inner needle hub 20. In the state where the inner needle unit 12 shown in FIG. 2 is pulled out from the outer needle unit 14, the needle tip protector 22 is moved to a position where the needle tip 16 of the inner needle 18 is accommodated in the cylindrical portion 40. . As will be described later, the needle tip 16 of the inner needle 18 cannot be removed from the proximal opening 60 of the needle tip protector 22.
 次に、外針ユニット14において、外針24は中空針形状を呈しており、適度な可撓性を有していることが好ましい。例えば、エチレン―テトラフルオロエチレン共重合体(ETFE)、ポリウレタン、ポリエーテルナイロン樹脂、ポリプロピレン等の各種の軟質樹脂により構成することができる。また、内針18の針先16と同様の理由から、外針24の遠位端62も、外径が先端に向かって漸減するテーパ状とされている。なお、外針24の遠位端62には、必要に応じて1つ以上の貫通穴を設けて、外針24への流体の流通を効率よく行うようにしてもよい。 Next, in the outer needle unit 14, the outer needle 24 has a hollow needle shape, and preferably has an appropriate flexibility. For example, it can be composed of various soft resins such as ethylene-tetrafluoroethylene copolymer (ETFE), polyurethane, polyether nylon resin, and polypropylene. For the same reason as the needle tip 16 of the inner needle 18, the distal end 62 of the outer needle 24 is also tapered so that the outer diameter gradually decreases toward the tip. It should be noted that the distal end 62 of the outer needle 24 may be provided with one or more through holes as required so that fluid can be efficiently distributed to the outer needle 24.
 外針24の近位端には、略円筒形状とされた外針ハブ26が液密に固着され、外針24の内腔98と外針ハブ26の内部とが連通されている。外針ハブ26は、遠位側に設けられた合成樹脂製の筒体64に対して、弾性チューブ66を介して、略円筒形状とされた合成樹脂製の外針コネクタ68が液密に固着された構成とされている。なお、外針コネクタ68の内周面には、他の医療用具との接続を可能とするメスルアーテーパ70が形成されている。外針コネクタ68の近位端付近外周上には、他の医療用具との接続を確実にするため、雄ねじ72が設けられている。なお、この外針コネクタ68を備えず、弾性チューブ66の可撓性を利用して他の医療用具と接続することも可能である。 An outer needle hub 26 having a substantially cylindrical shape is fixed to the proximal end of the outer needle 24 in a liquid-tight manner, and the lumen 98 of the outer needle 24 and the inside of the outer needle hub 26 are communicated with each other. In the outer needle hub 26, a synthetic resin outer needle connector 68 having a substantially cylindrical shape is liquid-tightly fixed to a synthetic resin cylindrical body 64 provided on the distal side via an elastic tube 66. It is set as the structure. A female luer taper 70 that allows connection to other medical devices is formed on the inner peripheral surface of the outer needle connector 68. On the outer periphery near the proximal end of the outer needle connector 68, a male screw 72 is provided to ensure connection with other medical devices. The outer needle connector 68 is not provided, and it is possible to connect to other medical devices using the flexibility of the elastic tube 66.
 外針ハブ26の外針コネクタ68の近位端には、外針キャップ28が取り付けられている。外針キャップ28は、合成樹脂製の円筒部材74の内部に弾性パッキン76a、76bが配設された構造とされている。円筒部材74の遠位側には、外針コネクタ68のメスルアーテーパ70に液密に連結される管状突起78が設けられている。さらに管状突起78の周囲を囲むようにガイド壁部80が突設されており、ガイド壁部80の内部には外針コネクタ68の雄ねじ72が螺合される雌ねじ82が形成されている。管状突起78の近位端側の開口部は弾性パッキン76により液密に覆蓋されている。 The outer needle cap 28 is attached to the proximal end of the outer needle connector 68 of the outer needle hub 26. The outer needle cap 28 has a structure in which elastic packings 76a and 76b are disposed inside a cylindrical member 74 made of synthetic resin. On the distal side of the cylindrical member 74, a tubular protrusion 78 is provided that is fluid-tightly connected to the female luer taper 70 of the outer needle connector 68. Further, a guide wall portion 80 is provided so as to surround the tubular protrusion 78, and a female screw 82 into which the male screw 72 of the outer needle connector 68 is screwed is formed inside the guide wall portion 80. The opening on the proximal end side of the tubular projection 78 is covered with an elastic packing 76 in a liquid-tight manner.
 弾性パッキン76a、76bにはそれぞれ中央部分にスリット84a,84bが設けられており、それらスリット84a,84bを通じて内針18が貫通可能とされている。また、外針キャップ28から内針18を引き抜いた後は、弾性パッキン76により管状突起78の開口部が閉塞され、外針ユニット14の近位端から液体が流出するのを防ぐことが出来る。このように、外針キャップ28の管状突起78を外針コネクタ68のメスルアーテーパ70に連結しつつ、外針コネクタ68の雄ねじ72を外針キャップ28のガイド壁部80の雌ねじ82に螺合することにより、外針コネクタ68の近位端側開口部が外針キャップ28により液密に覆蓋されるようになっている。 The elastic packings 76a and 76b are respectively provided with slits 84a and 84b at the center portions, and the inner needle 18 can be passed through the slits 84a and 84b. In addition, after the inner needle 18 is pulled out from the outer needle cap 28, the opening of the tubular protrusion 78 is closed by the elastic packing 76, and the liquid can be prevented from flowing out from the proximal end of the outer needle unit 14. In this way, the male thread 72 of the outer needle connector 68 is screwed to the female thread 82 of the guide wall 80 of the outer needle cap 28 while the tubular protrusion 78 of the outer needle cap 28 is connected to the female luer taper 70 of the outer needle connector 68. Thus, the proximal end side opening of the outer needle connector 68 is covered with the outer needle cap 28 in a liquid-tight manner.
 さらに、外針キャップ28の円筒部材74の近位端側には、嵌合凹部86が開口形成されている。後述する図5(a),(b)に示すように、嵌合凹部86は、針先プロテクタ22の嵌合凸部42と同一の略かまぼこ状の非円形断面形状を有している。嵌合凹部86の平面状内周面を画成する周壁部88には、第二磁石90が固定的に配設されている。ここで、第二磁石90は、図1に示す外針ユニット14と内針ユニット12の組み付け状態において、第二磁石90の磁極が軸直方向で第一磁石54と同様に配列されていると共に、軸直方向において第一磁石54の外方側に第二磁石90が配設されている。これにより、外針キャップ28の嵌合凹部86に対して針先プロテクタ22の嵌合凸部42が嵌め合わされると共に、第一磁石54と第二磁石90の吸引力により針先プロテクタ22が外針キャップ28に離脱可能に吸着されるようになっている。 Furthermore, a fitting recess 86 is formed in the proximal end side of the cylindrical member 74 of the outer needle cap 28. As shown in FIGS. 5A and 5B, which will be described later, the fitting recess 86 has a substantially non-circular cross-sectional shape that is the same as the fitting protrusion 42 of the needle tip protector 22. A second magnet 90 is fixedly disposed on the peripheral wall 88 that defines the planar inner peripheral surface of the fitting recess 86. Here, in the assembled state of the outer needle unit 14 and the inner needle unit 12 shown in FIG. 1, the second magnet 90 has the magnetic poles of the second magnet 90 arranged in the straight axis direction in the same manner as the first magnet 54. The second magnet 90 is disposed on the outer side of the first magnet 54 in the axial direction. As a result, the fitting convex portion 42 of the needle tip protector 22 is fitted to the fitting concave portion 86 of the outer needle cap 28, and the needle tip protector 22 is removed by the attractive force of the first magnet 54 and the second magnet 90. The needle cap 28 is detachably adsorbed.
 次に、図3~図5を用いて本実施形態における留置針組立体使用時の工程を断面図にて説明する。図3(a),図4(a),図5(a)は留置針組立体使用前の状況で、図1に等しい。そして、内針18の針先16および外針24を体内に穿刺後、図3(b)に示すように相対的に内針ユニット12を外針ユニット14から引き抜く。外針ユニット14から内針ユニット12を引き抜くに際して、第一磁石54と第二磁石90の吸引力により針先プロテクタ22は外針キャップ28に吸着されていることから、内針18の引き抜き方向への移動に伴い外針キャップ28に吸着された針先プロテクタ22が針軸方向の遠位側移動端に移動する。そして、筒状部40の遠位側開口部52から内針18が離脱すると、閉塞部材56が第一および第二磁石54,90に吸引されて遠位側開口部52が閉塞される(図3(c)図4(b),図5(b)の状態)。さらに、内針18の針先16が近位側開口部60からの抜け出しが阻止されることにより、内針18の針先16が針先プロテクタ22の内部に収容された状態で、内針ユニット12が外針ユニット14から離脱されるようになっている(図3(d),図4(c),図5(c)の状態)。これによって、内針ユニット12と外針ユニット14は分離され、内針18の針先16が針先プロテクタ22内に収容された状態で、内針ユニット12を安全に廃棄することが可能となる。 Next, the steps when using the indwelling needle assembly in the present embodiment will be described with reference to FIGS. FIGS. 3 (a), 4 (a), and 5 (a) show the situation before using the indwelling needle assembly, which is equivalent to FIG. Then, after puncturing the needle tip 16 and the outer needle 24 of the inner needle 18 into the body, the inner needle unit 12 is relatively pulled out from the outer needle unit 14 as shown in FIG. When pulling out the inner needle unit 12 from the outer needle unit 14, the needle tip protector 22 is attracted to the outer needle cap 28 by the attractive force of the first magnet 54 and the second magnet 90, so that the inner needle 18 is pulled out. As the needle moves, the needle tip protector 22 adsorbed to the outer needle cap 28 moves to the distal side moving end in the needle axis direction. When the inner needle 18 is detached from the distal opening 52 of the tubular portion 40, the closing member 56 is attracted by the first and second magnets 54 and 90 to close the distal opening 52 (see FIG. 3 (c) FIG. 4 (b) and FIG. 5 (b)). Further, the needle tip 16 of the inner needle 18 is prevented from coming out of the proximal opening 60, so that the needle tip 16 of the inner needle 18 is accommodated inside the needle tip protector 22, and the inner needle unit 12 is disengaged from the outer needle unit 14 (states shown in FIGS. 3D, 4C, and 5C). As a result, the inner needle unit 12 and the outer needle unit 14 are separated, and the inner needle unit 12 can be safely discarded in a state where the needle tip 16 of the inner needle 18 is accommodated in the needle tip protector 22. .
 ここで、内針18の針先16の近位側開口部60からの抜け出しを阻止する機構について詳述する。図4に示すように、内針18は、針先16から所定距離だけ近位側に移動した箇所に、突起部92を有している。この突起部92は、針軸方向における外径寸法が、針先プロテクタ22の近位側開口部60の内径寸法よりも大きく且つ遠位側開口部52a,52bの内径寸法よりも小さくされている。これにより、内針18の針先16は、針先プロテクタ22の遠位側開口部52b,52aを通過して針先プロテクタ22の筒状部40の内部に収容可能である一方、針先プロテクタ22の近位側開口部60を通過することができず、針先16の針先プロテクタ22からの抜け出しが阻止されるようになっている。内針18における突起部92の形成部位は、図4(c)に示すように、突起部92が針先プロテクタ22の近位側開口部60の周縁部に当接した際に、針先16が筒状部40の内部に完全に収容されるように設定される。また、内針18の突起部92よりも近位側において、内針18の外径よりも僅かに大きく、且つ突起部92が挿通不能な内径を有する金属リング94を配設することが望ましい。これにより、針先プロテクタ22の近位側開口部60からの内針18の抜け出しをさらに確実に防止できる。なお、図3においては、図面明瞭化の目的から突起部92および金属リング94の図示を省略している。 Here, a mechanism for preventing the inner needle 18 from coming out of the proximal end opening 60 of the needle tip 16 will be described in detail. As shown in FIG. 4, the inner needle 18 has a protruding portion 92 at a location moved proximally from the needle tip 16 by a predetermined distance. The protrusion 92 has an outer diameter dimension in the needle axis direction that is larger than an inner diameter dimension of the proximal opening 60 of the needle tip protector 22 and smaller than an inner diameter dimension of the distal openings 52a and 52b. . As a result, the needle tip 16 of the inner needle 18 can be accommodated inside the tubular portion 40 of the needle tip protector 22 through the distal openings 52b and 52a of the needle tip protector 22, while the needle tip protector. 22 cannot pass through the proximal opening 60 of the needle 22 so that the needle tip 16 is prevented from coming out of the needle tip protector 22. As shown in FIG. 4C, the formation portion of the protrusion 92 in the inner needle 18 is formed when the protrusion 92 contacts the peripheral edge of the proximal opening 60 of the needle tip protector 22. Is set to be completely accommodated inside the cylindrical portion 40. Further, it is desirable to dispose a metal ring 94 having an inner diameter that is slightly larger than the outer diameter of the inner needle 18 and through which the protrusion 92 cannot be inserted, on the proximal side of the protrusion 92 of the inner needle 18. Thereby, the inner needle 18 can be further prevented from coming out of the proximal opening 60 of the needle tip protector 22. In FIG. 3, the protrusion 92 and the metal ring 94 are not shown for the purpose of clarifying the drawing.
 このような突起部92は、例えば、針先プロテクタ22の近位側開口部60、筒状部40、遠位側開口部52a,52bを順に挿通された内針18の所定位置に対して、潰し加工等を施すことにより設けることができる。また、内針18の所定位置に別体の弾性リングを圧着させて突起部92を設けることもできる。
さらに、針先プロテクタ22の筒状部40の内部空間に血液・体液などを吸収する液体吸収体(図示しない)を備えても良い。液体吸収体の材質としては、例えばスポンジ、ポリウレタン、ゴム状弾性部材等が挙げられる。
Such a protrusion 92 is, for example, with respect to a predetermined position of the inner needle 18 inserted through the proximal opening 60, the tubular portion 40, and the distal openings 52a and 52b of the needle tip protector 22 in this order. It can be provided by crushing or the like. Alternatively, the protrusion 92 can be provided by pressing a separate elastic ring at a predetermined position of the inner needle 18.
Furthermore, a liquid absorber (not shown) that absorbs blood, body fluid, and the like may be provided in the internal space of the tubular portion 40 of the needle tip protector 22. Examples of the material of the liquid absorber include sponge, polyurethane, rubber-like elastic member, and the like.
 このような構造とされた本実施形態の留置針組立体10においては、図4に拡大して示すように、針先プロテクタ22の筒状部40に設けられた第一磁石54の磁極が、内針18を挟んだ針軸方向に直交する軸直方向において、閉塞部材56に直接対向するように向けられている。それ故、第一磁石54の磁力を効率的に閉塞部材56に及ぼすことができることから、例えば人工透析治療等に用いる留置針組立体10のように内針18の径が大きくなり閉塞部材56が大型化すると共に第一磁石54と閉塞部材56の離隔距離が増大する場合でも、内針18が遠位側開口部52から離脱した際の閉塞部材56の吸引を確実に行い、内針18の針先プロテクタ22の遠位側開口部52からの再突出を確実に防止することができる。また、外針キャップ28に設けた第二磁石90を、軸直方向で第一磁石54と同様に磁極を配列すると共に第一磁石54の外方に位置するように配設することにより、第一磁石54と第二磁石90の吸引力を相互に効率的に及ぼして、外針キャップ28への針先プロテクタ22の吸着を確実に行うことができる。さらに、第一磁石54と第二磁石90の磁極を軸直方向で同様に配列して且つ軸直方向で両磁石54,90を重ね合わせるように配設したことから、必要な磁石の配列をうまく工夫することにより、部品点数の増大や部材の磁石の大型化を回避しつつ、閉塞部材56をより大きな磁力で吸引することができるのである。 In the indwelling needle assembly 10 of this embodiment having such a structure, as shown in an enlarged view in FIG. 4, the magnetic pole of the first magnet 54 provided on the cylindrical portion 40 of the needle tip protector 22 is In the direction perpendicular to the needle axis direction across the inner needle 18, it is directed so as to directly face the closing member 56. Therefore, since the magnetic force of the first magnet 54 can be efficiently applied to the closing member 56, the diameter of the inner needle 18 is increased as in the indwelling needle assembly 10 used for, for example, artificial dialysis treatment, and the closing member 56 is Even when the distance between the first magnet 54 and the closing member 56 increases as the size increases, the closing member 56 is reliably sucked when the inner needle 18 is detached from the distal opening 52, and the inner needle 18 is Re-protrusion from the distal opening 52 of the needle tip protector 22 can be reliably prevented. Further, the second magnet 90 provided on the outer needle cap 28 is arranged so that the magnetic poles are arranged in the direction perpendicular to the axis in the same direction as the first magnet 54 and located outside the first magnet 54. The suction force of the one magnet 54 and the second magnet 90 can be effectively applied to each other, and the needle tip protector 22 can be reliably attracted to the outer needle cap 28. Furthermore, since the magnetic poles of the first magnet 54 and the second magnet 90 are similarly arranged in the direction perpendicular to the axis and the magnets 54 and 90 are arranged so as to overlap each other in the direction perpendicular to the axis, the necessary arrangement of the magnets can be changed. By devising well, the closing member 56 can be attracted with a larger magnetic force while avoiding an increase in the number of parts and an increase in the size of the magnet of the member.
 例えば、閉塞部材56,第一磁石54,第二磁石90に使用される磁石の材料としては、特に限定されないがサマコバ磁石、アルニコ磁石、ネオジウム磁石、フェライト磁石等が挙げられる。なお、閉塞部材56は第一磁石54,第二磁石90に対する位置決めの容易性から、磁性材で形成されることが望ましい。閉塞部材56に用いる磁性体の材料としては、磁石が吸着するものであれば特に限定しないが、耐錆性のよいステンレス等の磁性材が好ましい。また、閉塞部材56の形状としては、内針18抜去後の針先プロテクタ22の筒状部40の遠位側開口部52を塞ぐことのできる形状であれば特に限定されないが、本実施形態の如く薄肉円盤形状のものが好ましい。円形形状の閉塞部材56であれば、外周面に角部がなく第一磁石54に吸引される際に磁石収容空間48の内面への引っ掛かり等が回避されて、円滑な移動が可能となるからである。 For example, the material of the magnet used for the closing member 56, the first magnet 54, and the second magnet 90 is not particularly limited, and examples include a Samakova magnet, an Alnico magnet, a neodymium magnet, and a ferrite magnet. The closing member 56 is preferably made of a magnetic material because of the ease of positioning with respect to the first magnet 54 and the second magnet 90. The material of the magnetic material used for the closing member 56 is not particularly limited as long as the magnet can adsorb, but a magnetic material such as stainless steel having good rust resistance is preferable. Further, the shape of the closing member 56 is not particularly limited as long as it is a shape that can close the distal side opening 52 of the tubular portion 40 of the needle tip protector 22 after the inner needle 18 is removed. Thus, a thin disk shape is preferable. Since the circular closure member 56 has no corners on the outer peripheral surface, it can be smoothly moved by being prevented from being caught on the inner surface of the magnet housing space 48 when attracted to the first magnet 54. It is.
 また、図5に示すように、外針キャップ28の嵌合凹部86が略かまぼこ状の非円形断面とされている一方、針先プロテクタ22の嵌合凸部42が、嵌合凹部86と同一の非円形断面で突出すると共に嵌合凹部86よりもわずかに小さな外形形状を有している。これにより、嵌合凹部86と嵌合凸部42を嵌合するのみで、外針キャップ28と針先プロテクタ22が内針18の針軸周りで高度に位置決めされることとなる。それ故、第一磁石54と第二磁石90を確実に軸直方向で対向配置することができ、第一磁石54と第二磁石90による所望の吸着力を確実に得ることができる。 Further, as shown in FIG. 5, the fitting concave portion 86 of the outer needle cap 28 has a substantially semicircular non-circular cross section, while the fitting convex portion 42 of the needle tip protector 22 is the same as the fitting concave portion 86. And has an outer shape slightly smaller than the fitting recess 86. Thereby, the outer needle cap 28 and the needle tip protector 22 are highly positioned around the needle axis of the inner needle 18 only by fitting the fitting concave portion 86 and the fitting convex portion 42. Therefore, the first magnet 54 and the second magnet 90 can be reliably arranged to face each other in the axial direction, and a desired attraction force by the first magnet 54 and the second magnet 90 can be obtained with certainty.
 特に、外針キャップ28の嵌合凹部86において、平面状内周面を画成するために厚肉とされた周壁部88を巧く利用して、第二磁石90の収容スペースを確保している。従って、留置針組立体の全体サイズを大型化することなく、第一磁石54と第二磁石90の軸直方向の対向配置を実現し得て、大きな磁力を閉塞部材56に及ぼすことができるのである。 In particular, in the fitting recess 86 of the outer needle cap 28, a space for accommodating the second magnet 90 is ensured by skillfully utilizing the thick peripheral wall portion 88 to define the planar inner peripheral surface. Yes. Accordingly, the first magnet 54 and the second magnet 90 can be arranged opposite to each other in the axial direction without increasing the overall size of the indwelling needle assembly, and a large magnetic force can be exerted on the closing member 56. is there.
 以上、本発明の実施形態について詳述したが、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、第一磁石と第二磁石は、針軸に直交する軸直方向で同様に磁極が配列されて対向配置されていればよく、実施形態とN極S極の配列が反対となるように配設しても同様の作用効果が得られることは言うまでもない。 As mentioned above, although embodiment of this invention was explained in full detail, this invention is not limited by the specific description. For example, the first magnet and the second magnet need only be arranged opposite to each other so that the magnetic poles are similarly arranged in the direction perpendicular to the needle axis, and the arrangement of the N pole and the S pole is opposite to that of the embodiment. Needless to say, the same effects can be obtained even if they are arranged.
 外針キャップ28の嵌合凹部86と針先プロテクタ22の嵌合凸部42は周方向での位置決めが容易な非円形断面で構成されていれば具体的な形状に限定されない。例えば、前記実施形態の略かまぼこ状の断面形状の他、矩形断面や多角形断面等であってもよい。 The fitting concave portion 86 of the outer needle cap 28 and the fitting convex portion 42 of the needle tip protector 22 are not limited to specific shapes as long as they are configured with a non-circular cross section that can be easily positioned in the circumferential direction. For example, in addition to the substantially semi-cylindrical cross-sectional shape of the embodiment, a rectangular cross-section, a polygonal cross-section, or the like may be used.
 また、外針キャップ28の嵌合凹部86と針先プロテクタ22の嵌合凸部42の重ね合わせ面間に凹凸係合部を設けて、更なる位置決め精度の向上を図るようにしてもよい。 Further, an uneven engagement portion may be provided between the overlapping surfaces of the fitting concave portion 86 of the outer needle cap 28 and the fitting convex portion 42 of the needle tip protector 22 so as to further improve the positioning accuracy.
 さらに、閉塞部材56の近位端側には、針先プロテクタ22の筒状部40の遠位側開口部52を塞いで針先プロテクタ22の筒状部40の内部空間に内針18の針先16を格納した際、針先16が当接しうる部分に円錐状の凹部が形成されていても良い。該凹部により、内針18が針先プロテクタ22内部で位置ずれした場合に、針先16が針先プロテクタ22の筒状部40の遠位側開口部52を塞ぐ閉塞部材56を押しのけて遠位側開口部52から突出したり、遠位側開口部52以外の場所から突出したりすることを防ぐことができる。 Further, on the proximal end side of the closing member 56, the distal opening 52 of the cylindrical portion 40 of the needle tip protector 22 is closed to fill the inner space of the cylindrical portion 40 of the needle tip protector 22 with the needle of the inner needle 18. When the tip 16 is stored, a conical recess may be formed in a portion where the needle tip 16 can come into contact. When the inner needle 18 is displaced in the needle tip protector 22 due to the recess, the needle tip 16 pushes the blocking member 56 that closes the distal opening 52 of the tubular portion 40 of the needle tip protector 22 and moves distally. Protruding from the side opening 52 or protruding from a place other than the distal opening 52 can be prevented.
10:留置針組立体、12:内針ユニット、14:外針ユニット、16:針先、18:内針、20:内針ハブ、22:針先プロテクタ、24:外針、26:外針ハブ、28:外針キャップ、40:筒状部、42:嵌合凸部、52:遠位側開口部、54:第一磁石、56:閉塞部材、60:近位側開口部、86:嵌合凹部、88:周壁部、90:第二磁石 10: Indwelling needle assembly, 12: Inner needle unit, 14: Outer needle unit, 16: Needle tip, 18: Inner needle, 20: Inner needle hub, 22: Needle tip protector, 24: Outer needle, 26: Outer needle Hub: 28: outer needle cap, 40: cylindrical portion, 42: fitting convex portion, 52: distal opening, 54: first magnet, 56: occlusion member, 60: proximal opening, 86: Fitting recess, 88: peripheral wall, 90: second magnet

Claims (4)

  1.  遠位端に針先を有する内針と、該内針の近位端に取り付けられた内針ハブと、該内針に対して針軸方向に移動可能に装着された針先プロテクタを備えた内針ユニットと、
     前記内針が挿通可能な外針と、該外針の近位端に取り付けられて該内針が挿通可能な外針ハブと、該外針ハブの近位端に着脱可能に取り付けられて該内針が挿通可能であると共に前記外針ハブの近位端を覆蓋する外針キャップを備えた外針ユニットとを含み、
     前記内針が前記外針キャップおよび前記外針ハブに挿通されて前記外針の内部に収容配置されると共に、該外針キャップに前記内針ユニットが当接されることにより前記内針ユニットと前記外針ユニットが互いに組み付けられてなる留置針組立体において、
     前記内針ユニットの前記針先プロテクタは、前記内針が挿通配置された筒状部を備え、該筒状部の遠位側には、該内針が挿通された遠位側開口部が形成されていると共に、該遠位側開口部を挟んで前記針軸方向に直交する軸直方向の一方の側に該軸直方向で磁極が配列された第一磁石が固定的に配設されている一方、該軸直方向の他方の側に該第一磁石に吸引可能とされて該遠位側開口部を閉塞可能な閉塞部材が該第一磁石側に移動可能に配設されており、且つ該筒状部の近位側には、該内針が挿通された近位側開口部が形成されていると共に、該内針の前記針先が該近位側開口部から抜け出し不能に組み付けられている一方、
     前記外針ユニットの前記外針キャップには第二磁石が配設されており、該外針ユニットと前記内針ユニットの組み付け状態において、前記第二磁石の磁極が前記軸直方向で前記第一磁石と同様に配列されていると共に、該軸直方向において該第一磁石の外方側に該第二磁石が配設されるようになっており、該第一磁石と該第二磁石の吸引力により前記針先プロテクタが前記外針キャップに離脱可能に吸着されていることを特徴とする留置針組立体。
    An inner needle having a needle tip at a distal end, an inner needle hub attached to the proximal end of the inner needle, and a needle tip protector attached to the inner needle so as to be movable in the needle axis direction An inner needle unit,
    An outer needle through which the inner needle can be inserted, an outer needle hub attached to the proximal end of the outer needle and through which the inner needle can be inserted, and a detachably attached to the proximal end of the outer needle hub An outer needle unit having an outer needle cap through which an inner needle can be inserted and covering a proximal end of the outer needle hub,
    The inner needle is inserted into the outer needle cap and the outer needle hub and accommodated in the outer needle, and the inner needle unit is brought into contact with the outer needle cap, thereby In the indwelling needle assembly in which the outer needle units are assembled to each other,
    The needle tip protector of the inner needle unit includes a cylindrical portion through which the inner needle is inserted, and a distal side opening through which the inner needle is inserted is formed on the distal side of the cylindrical portion. And a first magnet having magnetic poles arranged in a direction perpendicular to the axis is fixedly disposed on one side of the axis perpendicular to the needle axis direction across the distal opening. On the other hand, a closing member that can be attracted to the first magnet on the other side in the axial direction and can close the distal opening is movably disposed on the first magnet side, A proximal opening through which the inner needle is inserted is formed on the proximal side of the cylindrical portion, and the needle tip of the inner needle is assembled so that it cannot be pulled out from the proximal opening. While
    A second magnet is disposed on the outer needle cap of the outer needle unit. When the outer needle unit and the inner needle unit are assembled, the magnetic pole of the second magnet is in the direction perpendicular to the first axis. The magnets are arranged in the same manner as the magnets, and the second magnets are arranged on the outer sides of the first magnets in the direction perpendicular to the axis. The attraction of the first magnets and the second magnets The indwelling needle assembly, wherein the needle tip protector is detachably attracted to the outer needle cap by force.
  2.  前記外針キャップには、近位端側に開口する非円形断面の嵌合凹部が設けられていると共に該嵌合凹部の周壁部に前記第二磁石が配設されている一方、
     前記針先プロテクタの前記筒状部の遠位端には、該嵌合凹部と同一の非円形断面で突出すると共に該嵌合凹部よりもわずかに小さな外形形状を有する嵌合凸部が設けられており、
     前記嵌合凹部と前記嵌合凸部の嵌合により前記外針キャップと前記針先プロテクタが前記内針の針軸周りで位置決めされていると共に、前記第一磁石と前記第二磁石が前記軸直方向で対向配置されるようになっている請求項1に記載の留置針組立体。
    While the outer needle cap is provided with a fitting recess having a non-circular cross section that opens to the proximal end side, the second magnet is disposed on the peripheral wall portion of the fitting recess,
    The distal end of the cylindrical portion of the needle tip protector is provided with a fitting convex portion protruding in the same non-circular cross section as the fitting concave portion and having a slightly smaller outer shape than the fitting concave portion. And
    The outer needle cap and the needle tip protector are positioned around the needle axis of the inner needle by the fitting of the fitting recess and the fitting protrusion, and the first magnet and the second magnet are positioned on the shaft. The indwelling needle assembly according to claim 1, wherein the indwelling needle assembly is arranged to face each other in a straight direction.
  3.  前記閉塞部材が磁性体で形成されている請求項1又は2に記載の留置針組立体。 The indwelling needle assembly according to claim 1 or 2, wherein the closing member is made of a magnetic material.
  4.  前記閉塞部材が円盤形状とされており、前記遠位側開口部を覆蓋し得る外径を有している請求項1~3の何れか1項に記載の留置針組立体。 The indwelling needle assembly according to any one of claims 1 to 3, wherein the closing member has a disk shape and has an outer diameter capable of covering the distal opening.
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JP2021511890A (en) * 2018-01-31 2021-05-13 スミスズ メディカル エーエスディー,インコーポレイティド Releasable safety catheter insertion assembly
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JP2016007429A (en) * 2014-06-25 2016-01-18 ニプロ株式会社 Indwelling needle
JP2017520344A (en) * 2014-07-08 2017-07-27 ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company Set using fluid transfer device or retractable needle and septum
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JPWO2017183427A1 (en) * 2016-04-19 2019-02-28 ニプロ株式会社 Indwelling needle and indwelling needle assembly
JP7134410B2 (en) 2016-04-19 2022-09-12 ニプロ株式会社 Indwelling needle and indwelling needle assembly
WO2018026006A1 (en) * 2016-08-04 2018-02-08 ニプロ株式会社 Valved needle assembly, and indwelling needle assembly
CN109562253A (en) * 2016-08-04 2019-04-02 尼普洛株式会社 Needle assemblies and indwelling needle assembly with valve
JPWO2018026006A1 (en) * 2016-08-04 2019-06-06 ニプロ株式会社 Valved needle assembly and indwelling needle assembly
JP7174353B2 (en) 2016-08-04 2022-11-17 ニプロ株式会社 Valved needle assembly and indwelling needle assembly
CN115282461A (en) * 2016-08-04 2022-11-04 尼普洛株式会社 Needle assembly with valve and indwelling needle assembly
JP2018068733A (en) * 2016-10-31 2018-05-10 ニプロ株式会社 Indwelling needle assembly
JP2021511890A (en) * 2018-01-31 2021-05-13 スミスズ メディカル エーエスディー,インコーポレイティド Releasable safety catheter insertion assembly
JP2019034192A (en) * 2018-11-01 2019-03-07 ニプロ株式会社 Indwelling needle
WO2020209368A1 (en) 2019-04-11 2020-10-15 ニプロ株式会社 Indwelling needle assembly
US11338114B2 (en) 2019-07-09 2022-05-24 Becton, Dickinson And Company Magnetic catheter system and methods
WO2021007104A1 (en) * 2019-07-09 2021-01-14 Becton, Dickinson And Company Magnetic catheter system and methods
CN112206376A (en) * 2019-07-09 2021-01-12 贝克顿·迪金森公司 Magnetic catheter system and method
CN112206376B (en) * 2019-07-09 2023-02-03 贝克顿·迪金森公司 Magnetic catheter system and method
WO2021126640A1 (en) * 2019-12-18 2021-06-24 Becton, Dickinson And Company Inhibiting fluid leakage and splatter in catheter devices and systems
WO2023220845A1 (en) * 2022-05-16 2023-11-23 百仕韦(长汀)医疗器械有限公司 Hemodialysis needle with swing brake pad

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