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WO2017057476A1 - Aiguille creuse en résine médicale, ensemble d'instrumentation médicale l'utilisant, et cylindre externe muni d'une pièce de ponction - Google Patents

Aiguille creuse en résine médicale, ensemble d'instrumentation médicale l'utilisant, et cylindre externe muni d'une pièce de ponction Download PDF

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Publication number
WO2017057476A1
WO2017057476A1 PCT/JP2016/078653 JP2016078653W WO2017057476A1 WO 2017057476 A1 WO2017057476 A1 WO 2017057476A1 JP 2016078653 W JP2016078653 W JP 2016078653W WO 2017057476 A1 WO2017057476 A1 WO 2017057476A1
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WO
WIPO (PCT)
Prior art keywords
puncture
hollow needle
medical
distal end
outer cylinder
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2016/078653
Other languages
English (en)
Japanese (ja)
Inventor
るり子 飯渕
滋晃 冨家
学 有延
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
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 Terumo Corp filed Critical Terumo Corp
Priority to JP2017543497A priority Critical patent/JPWO2017057476A1/ja
Publication of WO2017057476A1 publication Critical patent/WO2017057476A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles

Definitions

  • the present invention relates to a medical medical hollow needle for medical use, a medical device set using the hollow needle, an outer cylinder with a puncture portion, and a prefilled syringe.
  • the present invention relates to a medical resin hollow needle that can be connected by puncturing to a port for co-infusion of an infusion solution container, a medical device set using the same, and an outer cylinder with a puncture unit.
  • a hollow needle for example, a hollow needle that communicates with an inner hole and has a side hole opened to the side of a distal end portion is known.
  • a medical resin hollow needle described in Japanese Patent Application Laid-Open No. 2006-55670 is a slot formed on the side of the tip of the cannula 310. 338, an opening 358 formed on the side of the tip of the cannula 340, and the like.
  • a medical resin hollow needle described in US Pat. No. 4,058,121 (Patent Document 2) is provided with a port 10 formed on the side of the tip of the hollow needle 1.
  • a medical resin hollow needle described in US Publication No. 2007-78429 (Patent Document 3) includes a port 38 formed on the side of the tip of the cannula 14. In administration to the vein and blood collection, drug administration and blood collection are performed via the port of the vein line using the medical resin hollow needle as described above.
  • JP 2006-55670 A JP 2003-126269 A, US Publication 2001/47154
  • US Patent Publication No. 4058121 US Publication No. 2007-78429
  • a staying portion that is, a flushing defective portion may occur in the port.
  • a stay portion may be generated in the port, and the hollow needle may be detached during the flushing operation.
  • the diameter of the puncture site of the rubber stopper of the port may be increased, and liquid leakage may occur from the puncture trace after the hollow needle is removed.
  • An object of the present invention is to provide a medical resin hollow needle that can reliably flush the inside of the port and that causes very little liquid leakage from the port when the hollow needle is removed, and a medical device set and puncture using the same.
  • An outer cylinder with a part is provided.
  • a medical resin hollow needle having a puncture portion at the distal end and a luer taper nozzle of a medical device and a hub portion attachable to the proximal end
  • the puncture portion includes a puncture end portion having a solid puncture end that is tapered toward the tip, and a hollow portion that is continuous with the puncture end portion and extends to the proximal end side
  • the hollow portion has a lumen communicating with the inside of the hub portion, and a side hole penetrating the side wall of the hollow portion and communicating the lumen and the outside, and the side hole on the side of the puncture end portion
  • the distal wall is a medical resin hollow needle extending in the proximal direction from the lumen toward the outside.
  • a medical device set comprising the medical resin hollow needle and a medical device
  • the medical device includes a cylindrical outer cylinder main body, an outer cylinder provided at a distal end portion of the outer cylinder main body, and the Luer taper nozzle having a distal end opening, and is slidable in the outer cylinder.
  • a medical device set which is a prefilled syringe comprising:
  • An outer cylinder with a puncture portion comprising a cylindrical outer cylinder main body portion and a puncture portion provided at a distal end portion of the outer cylinder main body portion,
  • the puncture portion includes a puncture end portion having a solid puncture end that is tapered toward the tip, and a hollow portion that is continuous with the puncture end portion and extends to the proximal end side,
  • the hollow portion has a lumen and a side hole that penetrates the side wall of the hollow portion and communicates the lumen with the outside, and the distal end wall of the side hole on the puncture end portion side is the inner wall.
  • An outer cylinder with a puncture portion extending in the proximal direction from the cavity toward the outside.
  • FIG. 1 is a front view of a medical resin hollow needle according to an embodiment of the present invention.
  • FIG. 2 is a plan view of the medical resin hollow needle shown in FIG.
  • FIG. 3 is a right side view of the medical resin hollow needle shown in FIG. 1.
  • FIG. 4 is a left side view of the medical resin hollow needle shown in FIG.
  • FIG. 5 is a cross-sectional view taken along line AA in FIG.
  • FIG. 6 is a perspective view of the medical resin hollow needle shown in FIG.
  • FIG. 7 is an enlarged view of a front end portion of the front view of the medical resin hollow needle shown in FIG. 1.
  • FIG. 8 is an enlarged view of the tip of the cross-sectional view of the medical resin hollow needle shown in FIG. 5.
  • FIG. 9 is an explanatory diagram for explaining the action of the medical resin hollow needle of the present invention.
  • FIG. 10 is an explanatory diagram for explaining the action of the medical resin hollow needle of the present invention.
  • FIG. 11 is an explanatory diagram for explaining the action of the medical resin hollow needle of the present invention.
  • FIG. 12 is an explanatory diagram for explaining the action of the medical resin hollow needle of the present invention.
  • FIG. 13 is a cross-sectional view of the distal end portion of a medical resin hollow needle according to another embodiment of the present invention.
  • FIG. 14 is a front view of a medical resin hollow needle according to another embodiment of the present invention.
  • 15 is a cross-sectional view taken along line BB in FIG.
  • FIG. 16 is a front view of a medical device set according to an embodiment of the present invention.
  • FIG. 17 is a front view of an outer cylinder with a puncture unit according to an embodiment of the present invention.
  • 18 is a cross-sectional view taken along the line CC of FIG.
  • FIG. 19 is an enlarged cross-sectional view of the distal end portion of the cross-sectional view of the outer cylinder with puncture portion shown in FIG.
  • FIG. 20 is a front view of a prefilled syringe using the outer cylinder with a puncture portion shown in FIGS.
  • FIG. 21 is an explanatory diagram for explaining the distal end portion of the prefilled syringe shown in FIG. 20.
  • the medical resin hollow needle of the present invention will be described with reference to the illustrated embodiment.
  • the medical resin hollow needle 1 of the present invention has a puncture portion 10 at a distal end and a hub portion 5 that can be attached to a luer taper nozzle of a medical device at a proximal end.
  • the puncture portion 10 includes a puncture end portion 2 having a solid puncture end 2a that is tapered toward the tip, and a hollow portion 3 that is continuous with the puncture end portion 2 and extends to the proximal end side.
  • the hollow portion 3 has a lumen 11 that communicates with the inside of the hub portion 5, and side holes 7a and 7b that penetrate the side walls of the hollow portion 3 and communicate the lumen 11 and the outside, and the side holes 7a and 7b.
  • the distal end wall 71 (puncture end portion side portion) on the puncture end portion 2 side extends from the lumen 11 toward the outside in the proximal direction of the hollow portion 3.
  • the medical resin hollow needle 1 of this embodiment includes a puncture portion 10, a large diameter portion 4 having a larger diameter and a predetermined length than the hollow portion 3, and a large diameter portion 4.
  • a short taper portion 6 provided between the hollow portions 3 and a hub portion 5 provided at a proximal end and attachable to a luer taper nozzle of a medical device are provided.
  • the puncture portion 10 has a puncture end portion 2 and a hollow portion 3 extending a predetermined length from the proximal end of the puncture end portion 2.
  • the hollow portion 3 extends a predetermined length from the proximal end of the puncture end portion 2 and includes a lumen 11 therein.
  • the hollow portion 3 extends to the tip of the tapered portion 6.
  • the distal end portion of the hollow portion 3 is provided with side holes 7a and 7b that communicate the inside of the hollow needle 1 made of medical resin, in other words, the lumen 11 and the outside.
  • the puncture end 2 is tapered toward the tip, and has a puncture end 2a at the tip.
  • the puncture unit 10 can be connected to a container elastic seal member of a vial, a port of a medical device, or the like by puncturing.
  • the medical resin hollow needle 1 includes a solid tapered puncture end portion 2, a hollow portion 3, a tapered portion 6, and a tapered portion 6, as shown in FIG. A large diameter portion 4 and a hub portion 5 are provided.
  • the distal end portion 12 of the lumen 11 is reduced in diameter toward the distal end and ends without reaching the puncture end portion 2. ing. By doing so, the flush liquid can be discharged more obliquely backward. Furthermore, the liquid that has hit the wall at the tip of the lumen 11 tends to flow toward the side hole, and the flush effect is enhanced.
  • the side holes 7 a and 7 b are provided so as to communicate with the lumen 11 at the distal end portion of the lumen 11, specifically, at the proximal end portion from the reduced diameter portion.
  • the inner diameter of the lumen 11 is preferably 0.4 to 1.0 mm, particularly preferably 0.6 to 0.8 mm.
  • the puncture end 2 has a puncture end 2a at the distal end, and is solid with an acute taper angle (taper expansion angle) toward the proximal end side. It has become.
  • the tapered puncture end 2 is preferably a cone having a total length of 1.0 to 4.7 mm and a taper angle of 12 to 45 degrees.
  • the tapered puncture end 2 preferably has a total length of 1.7 to 4.0 mm and a taper angle of 14 to 30 degrees, a total length of 2.1 to 4.0 mm, and a taper angle of 14 to 25. More preferably.
  • the total length of the hollow part 3 including the puncture end 2 is 7 to 14 mm, and the maximum outer diameter of the hollow part 3 is 1.5 to 3.0 mm.
  • the hollow portion 3 including the puncture end 2 is sufficiently thin while maintaining strength and has a certain axial length, so that it is easy to puncture the elastic seal member of the vial and the like during puncture.
  • the puncture end 2 can be confirmed.
  • the full length L the shorter one tends to maintain the intensity
  • the total length is preferably 8 to 12 mm, and particularly preferably 9 to 11 mm.
  • the maximum outer diameter R of the hollow portion 3 is 1.8 to 2.6 mm.
  • the thickness is preferably 2.0 to 2.4 mm.
  • the hollow portion 3 has a gentle taper angle, and its proximal end has the maximum diameter.
  • the hollow portion 3 may have substantially no taper angle.
  • the distal end wall 71 which is a portion of the side holes 7a and 7b on the puncture end 2 side extends from the lumen 11 toward the outside in the proximal direction.
  • the entire side holes 7a and 7b extend in the proximal direction from the lumen 11 toward the outside.
  • the base end wall 72 which is a part on the base end side of the side holes 7a and 7b also extends in the base end direction from the lumen 11 to the outside.
  • the side holes 7a and 7b are quadrangular prisms that extend in the proximal direction from the lumen 11 toward the outside, in other words, from the lumen 11 with respect to the central axis of the hollow portion 3. It extends diagonally backward toward the outside.
  • the side holes 7a and 7b are formed by four wall surfaces, and as shown in FIG. 8, there are inclined surfaces that incline toward the base end side from the lumen 11 toward the outside. It has become.
  • the base end walls 72 of the side holes 7a and 7b are inclined surfaces that incline toward the base end side from the lumen 11 toward the outside.
  • the distal end wall 71 and the proximal end wall 72 are formed in parallel.
  • the two opposing side walls connecting the two inclined surfaces 71 and 72 extend substantially parallel to the central axis of the hollow portion.
  • the inclination angle of the inclined surface forming the distal end wall 71 and the proximal end wall 72 to the proximal end side with respect to the central axis of the hollow portion 3 is preferably 95 to 135 degrees, and particularly preferably 120 to 135 degrees. preferable.
  • the side holes 7a and 7b have a rectangular column shape that is long in the axial direction.
  • the axial length of the openings of the side holes 7a and 7b is preferably 0.5 to 2.5 mm, and particularly preferably 0.5 to 2.0 mm.
  • the circumferential length of the openings of the side holes 7a and 7b is preferably 0.3 to 1.0 mm, particularly preferably 0.4 to 0.8 mm.
  • the side holes 7 a and 7 b have an outer opening 73 and an inner opening 74.
  • the distal end of the outer opening 73 is located closer to the proximal end side than the distal end of the inner opening 74.
  • the distal end of the outer opening 73 is preferably located 0.03 to 1.3 mm proximal to the distal end of the inner opening 74. In particular, it is preferably located at the base end side of 0.18 to 1.3 mm.
  • the medical resin hollow needle 1 of this embodiment two side holes are provided so as to face each other.
  • three or more side holes may be provided so as to be substantially equiangular with respect to the central axis of the hollow portion 3. Further, there may be only one side hole.
  • the thickness (side wall thickness) of the hollow needle 1 in the portion where the side holes 7a and 7b are provided is preferably 0.3 to 1.3 mm, and particularly 0.6 to 1.0 mm. It is preferable that
  • both the distal end wall 71 and the proximal end wall 72 are inclined surfaces that are inclined toward the proximal end side from the lumen 11 to the outside, and are formed in parallel to each other.
  • the flash efficiency can be increased even if only the tip wall 71 on the tip side is the inclined surface as described above.
  • the number of the side holes 7a and 7b is provided in the position which opposes in the example mentioned above, it is good also as providing three or more side holes 7a and 7b.
  • the total opening area of the side holes 7a and 7b is preferably 0.15 to 7.5 mm 2 , and particularly preferably 0.2 to 4.8 mm 2 . Further, the opening area of each side hole 7a, 7b (the area of the outer surface opening and the inner surface opening) is preferably 0.15 to 2.5 mm 2 , particularly preferably 0.2 to 1.6 mm 2 .
  • the hollow needle 1 that is formed separately on the distal end side and the proximal end side and can be assembled integrally at the site in the side holes 7a and 7b, the hollow needle 1 formed of two parts may be used. it can.
  • the large-diameter portion 4 is a cylindrical portion extending from the distal end of the hub portion 5 in the distal direction, and has a length and an outer diameter that can maintain a stable connection state to a port or the like of the infusion container. Moreover, the large diameter part 4 has a gentle taper angle, and the base end has the maximum diameter. Thereby, while being able to hold
  • the tapered portion 6 that connects the proximal end of the hollow portion 3 and the distal end of the large-diameter portion 4 can be easily inserted into the elastic seal member of the port of the infusion container following the hollow portion 3, and The length and the taper angle are such that the large-diameter portion can enter the elastic seal member.
  • the lumen 15 from the tapered portion 6 to the large-diameter portion 4 includes three inner surface ribs 16 formed at equal angles around the central axis in order to reinforce the hollow needle 1. Yes.
  • the hub portion 5 is a cylindrical portion that extends rearward from the base end of the large diameter portion 4 and has an inner surface that can be attached to a luer taper nozzle of a medical device. Specifically, the inside of the hub portion 5 is provided with a 6% taper, so that a normal standard female female connection portion (for example, a nozzle portion of a syringe) having a 6% taper can be connected.
  • the standard medical female connection is ISO 594-1: 1986 “Matching joints with 6% (about 3.43 °) taper of syringe barrels, needles and other medical devices-Part 1 : General requirements ”.
  • two ribs 8a and 8b are provided on the outer surface of the base end portion of the hub portion 5 so as to face each other.
  • the ribs 8a and 8b can be used as screwed portions when screwed with screwed portions of other medical devices.
  • projecting portions 9a, 9b, 9c, 9d extending in the axial direction provided on the outer surface near the tip of the hub portion 5 are provided. This protruding portion can be used as a gripping portion of the hollow needle 1 and facilitates screwing of the hub portion 5 with another medical device.
  • the hub portion 5 is provided at the tip of the hub portion 5 and is provided at the tip of the hub portion 5 tip portion 5a and the hub portion 5 tip portion 5a.
  • a step portion 5b is provided.
  • the step portion 5b functions as a locking portion that stops the puncture of the medical resin hollow needle 1 when connected to the port of the infusion container.
  • the stepped portion 5b is a rapidly expanding tapered portion that has a short overall length and rapidly expands toward the rear.
  • Examples of the material for forming the hollow needle 1 made of medical resin include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer Polyester such as polyethylene terephthalate, cyclic olefin resin, polyether ether ketone, polybutylene terephthalate, polycarbonate, polyamide, polyacetal, modified polyphenylene ether, polyester resin, fluorine resin, polysulfone, polyetherimide, polyethersulfone, Thermoplastic resins such as polyether ketone, polyether lactone, and liquid crystal polyester, or epoxy resin, unsaturated polyester resin, phenol resin, urea Fat, melamine resins, such as thermosetting resin of the polyurethane resin.
  • Polyester such as polyethylene terephthalate, cyclic olefin resin, polyether ether ket
  • the medical resin hollow needle 1 of the present invention is connected to the mixed injection port or the discharge port of the infusion container, and the drug solution stays inside the hollow needle 1 after administration of the drug solution, infusion solution, blood product, or blood sampling, etc. And flushing blood.
  • a medical resin hollow needle 1 is provided as a hub on a nozzle portion of a syringe 30 filled with a medical fluid 57 as shown in FIG. Wear using part 5.
  • the syringe 30 is punctured by the hollow portion 3 including the puncture end portion 2 of the hollow needle 1 with the elastic seal member 42 of the vial 40.
  • the pusher 52 is pushed in, and the medical liquid 57 in the syringe 30 is injected into the vial 40.
  • the vial 40 is turned upside down with the syringe 30, and the pusher 52 is pulled so that the drug 43 is dissolved or diluted in the syringe 30. Aspirate. After the drug solution is sucked into the syringe 30, the syringe 30 to which the hollow needle 1 is connected is detached from the vial 40.
  • the syringe 30 filled with the medicinal solution is connected to the mixed injection port 63 of the infusion container 70 as shown in FIG.
  • the operation of connecting the syringe 30 filled with the medicinal solution to the co-infusion port 63 is performed by puncturing the elastic seal member 74 of the co-infusion port 63 with the distal end portion 3 including the puncture end portion 2 of the hollow needle 1. To do.
  • the puncture end 2 penetrates the elastic seal member 74 and the tip thereof reaches the mixed injection port 63.
  • the distal end portion 3 of the hollow needle 1 passes through the elastic seal member 74 and reaches the mixed injection port 63.
  • the tapered portion 6 of the hollow needle 1 passes through the elastic seal member 74, and the subsequent large diameter portion 4 passes through the elastic seal member 74 of the mixed injection port 63.
  • the large diameter portion 4 of the hollow needle 1 passes through the elastic seal member 74 of the mixed injection port 63, so that the syringe 30 to which the hollow needle 1 is connected is connected to the mixed injection port 63 of the infusion container 70. It will be in the state connected firmly. In this state, the drug solution can be injected into the infusion container by pushing the pusher 52. After the injection of the chemical solution is completed, the syringe 30 with the hollow needle 1 attached is detached from the infusion container.
  • a syringe 30 to which the hollow needle 1 as shown in FIG. 9 is connected is used.
  • the syringe 30 is filled with a flush solution (specifically, physiological saline, water for injection, heparinized physiological saline, etc.).
  • a flush solution specifically, physiological saline, water for injection, heparinized physiological saline, etc.
  • the elastic seal member 93 of the mixed injection port 92 is punctured by the puncture end portion 2 having the puncture end 2 a of the hollow needle 1, and the side holes 7 a and 7 b of the hollow portion 3 are in front of the elastic seal member 93.
  • Push in. the hollow portion 3 of the hollow needle 1 is held by the elastic seal member 93 of the mixed injection port 92.
  • the flushing is performed by pushing the pusher 52 of the syringe 30 to eject the flush liquid from the side holes 7a and 7b.
  • the medical resin hollow needle 1 of the present invention is such that the side holes 7a and 7b formed in the hollow portion 3 have portions on the side of the puncture end 2 facing the outside from the lumen 11. It extends in the end direction.
  • the distal end walls 71 of the side holes 7a and 7b are inclined surfaces that are inclined from the lumen 11 toward the outside toward the proximal end side. Therefore, at the time of flushing, the flush liquid flows out from the side holes 7a and 7b toward the proximal end of the hollow needle 1 as shown by dotted arrows in FIG.
  • the flush liquid flows also to the base end side portion from the side holes 7a and 7b, the stored liquid 94 in the flushing target portion can be surely replaced with the flush liquid. Moreover, there is little pressure loss at the time of flash work, and it is easy to eject the flash liquid. In addition, it is possible to reliably and easily flush the medicinal solution, blood, and the like remaining in the flushing target site where the hollow needle 1 is punctured without rotating the punctured hollow needle 1. Further, in the hollow needle 1 of this embodiment, since the distal end portion of the lumen 11 has a reduced diameter, the liquid hitting the wall portion of the distal end portion of the lumen 11 can easily flow toward the side hole, and the flush effect. Is also expensive.
  • the distal end portion 12a of the lumen 11 of the hollow portion 3 is substantially the same as the medical resin hollow needle 1e of the embodiment shown in FIG.
  • the inner diameter may extend from the side holes 7a and 7b in a predetermined length in the tip direction.
  • the distance between the tip of the inner opening 74 of the side hole of the lumen 11 and the tip of the tip portion 12a of the lumen 11 is preferably 0.5 to 2.0 mm, particularly preferably 0.5 to 1.0 mm.
  • the shape of the side hole in the medical resin hollow needle of the present invention is not limited to that described above.
  • the side holes may be circular, elliptical, polygonal or the like. And in the medical resin hollow needles of all the above-described embodiments, it may have only one side hole or may have three or more side holes.
  • the side hole has a smaller area of the outer opening 73 than the inner opening 74 as in the medical resin hollow needle 1e of the embodiment. It may be.
  • the side holes preferably have the largest cross section at the inner opening 74 and the smallest cross section at the outer opening 73. In other words, the side hole preferably has a smaller inner cavity from the inner opening 74 toward the outer opening 73.
  • the portion on the puncture end side (tip surface) of the side hole may be inclined at an acute angle with respect to the central axis of the hollow portion 3 from the portion on the base end side (base end surface) of the side hole. preferable.
  • the medical resin hollow needles 1h of the examples shown in FIGS. 14 and 15 may not have a large diameter portion.
  • the basic configuration of the medical resin hollow needle 1h of this embodiment is the same as the medical resin hollow needle 1 of the above-described embodiment.
  • the hollow needle 1h of this embodiment is not provided with a large diameter portion, and the proximal end of the tapered portion 6 provided at the proximal end portion of the hollow portion 3 is connected to the distal end of the hub portion 5.
  • the medical resin hollow needle 1h of this embodiment is provided with a hub portion 5 provided at the base end and attachable to a luer taper nozzle of a medical device, like the hollow needle 1, and this hub portion 5
  • a hollow portion 3 having a puncture end portion 2 at the distal end is provided on the distal end side.
  • the hollow portion 3 includes side holes 7 a and 7 b on the proximal end side of the puncture end portion 2.
  • the medical device set 100 of this embodiment includes a medical resin hollow needle 1 and a medical device 50.
  • a prefilled syringe 50 is used as a medical device.
  • As the prefilled syringe 50 a cylindrical outer cylinder main body 51a, an outer cylinder 51 provided at a distal end portion of the outer cylinder main body 51a, and a Luer taper nozzle 51b having a distal end opening, and a slide inside the outer cylinder 51 are provided.
  • the above-described medical resin hollow needle 1 is used.
  • the medical resin hollow needle 1 the medical resin hollow needles of all the above-described embodiments may be used. it can. Therefore, the puncture end portion side portions of the side holes 7a and 7b extend in the proximal direction from the lumen 11 to the outside.
  • the prefilled syringe 50 a known one is used.
  • the medical liquid 57 filled in the prefilled syringe 50 include a water solution for injection, a physiological saline solution, a glucose solution, or a solution, or a drug (for example, vitamins, minerals, cyclosporine, benzodiazepines). , Sodium chloride injection solution, antibiotics, protein preparation), and a chemical solution capable of dissolving or diluting the powder preparation in the vial.
  • the prefilled syringe 50 includes a sealing member 53 (specifically, a removable cap) attached to the luer taper nozzle 51b in order to seal the distal end opening of the outer cylinder 51.
  • the sealing member may be a peelable film.
  • the outer cylinder 51 is a cylindrical body made of a transparent or translucent material and, if necessary, a material having low oxygen permeability and water vapor permeability.
  • the outer cylinder 51 includes a main body 51a, the above-described luer taper nozzle 51b, and a flange 56 provided at the rear end.
  • the luer taper nozzle 51b is a normal standard female female connector.
  • the standard medical female connection is ISO 594-1: 1986 “Matching joints with 6% (about 3.43 °) taper of syringe barrels, needles and other medical devices-Part 1 : General requirements ”.
  • the gasket 54 includes a main body portion extending at substantially the same outer diameter and a plurality of annular ribs (two in this embodiment) provided on the main body portion. Slide while in close contact.
  • a pusher 52 is connected to the gasket 54 at its rear end. The pusher 52 may be attached at the time of use.
  • the pusher 52 includes a pressing portion 55 at the rear end.
  • the medical device set of the present invention may include a vial that contains a medicine to be dissolved or diluted by the medical liquid 57 filled in the prefilled syringe 50.
  • the medical device set according to the present invention includes a vial containing a medicine to be dissolved or diluted by the medical liquid 57 of the prefilled syringe 50 and an infusion solution containing a liquid infusion containing a drug solution in which the medicine is dissolved or diluted.
  • a container may be provided.
  • the outer cylinder 21 with a puncture portion of the present invention includes a cylindrical outer cylinder main body portion 23 and a puncture portion 22 provided at the distal end portion of the outer cylinder main body portion 23.
  • the puncture portion includes a puncture end portion 32, a hollow portion 33, a large diameter portion 34 having a larger diameter and a predetermined length than the hollow portion 33, and a short tapered portion 36 provided between the large diameter portion 34 and the hollow portion 33. Is provided.
  • the hollow portion 33 is provided on the proximal end side with a predetermined length from the puncture end 32a and on the distal end side with a predetermined length from the tapered portion 36, and has side holes 37a and 37b communicating the inner hole 15 of the hollow portion 3 with the outside, and a tapered shape. And a puncture end 32.
  • the basic structure of the hollow part 33 in the outer cylinder 21 with a puncture part of this embodiment is the same as the hollow part 3 of the medical resin hollow needle 1 described above.
  • the outer cylinder 21 with a puncture portion includes a puncture end portion 32, a hollow portion 33, a large diameter portion 34 having a larger diameter and a predetermined length than the hollow portion 33, and a short taper provided between the large diameter portion 34 and the hollow portion 33.
  • the base part 35 which connects the part 36 and the shoulder part 24 of the outer cylinder main-body part 23 and the large diameter part 34 is provided. Further, the inner diameter 15 of the large diameter portion 34 and the hollow portion 33 communicate with the internal space 19 of the outer cylinder main body portion 21.
  • the hollow part 33 which has the side holes 37a and 37b in the outer cylinder 21 with a puncture part of this Example is demonstrated.
  • the shape of the hollow portion 33 is the same as that of the hollow portion 3 of the medical resin hollow needle 1 described above.
  • the side holes 37 a and 37 b communicate the internal space 19 of the outer cylinder 21 with a puncture portion and the outside through the inner cavity 38 of the hollow portion 33.
  • the large diameter portion 34 is a cylindrical portion that extends in the distal direction from the distal end of the pedestal portion 35.
  • the shape of the large diameter portion 34 is the same as the large diameter portion 4 of the medical resin hollow needle 1 described above.
  • the shape of the tapered portion 36 connecting the base end of the hollow portion 33 and the distal end of the large diameter portion 34 is the same as the tapered portion 6 of the medical resin hollow needle 1 described above.
  • the shape of the side holes 37a and 37b is the same as the side holes 7a and 7b of the medical resin hollow needle 1 described above.
  • the side holes 37a and 37b on the puncture end portion 32 side are inclined surfaces extending in the proximal direction from the lumen 38 toward the outside.
  • hook made from a medical resin of all the Examples mentioned above can be used as a shape of the hollow part containing a side hole.
  • the outer cylinder main body portion 23 includes a cylindrical main body portion, a shoulder portion 24 located at the distal end portion, and a flange portion 28 provided at the proximal end. And as above-mentioned, the outer cylinder main-body part 23 and the hollow part 33 are connected by the base part 35. As shown in FIG.
  • the pedestal portion 35 is a cylindrical portion having a larger diameter than the large diameter portion 34, and a stepped portion 35 a is formed between the pedestal portion 35 and the large diameter portion 34.
  • Examples of the material for forming the outer cylinder 21 with puncture portion of the present invention include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene.
  • Various resins such as copolymers, polyesters such as polyethylene terephthalate, cyclic olefin polymers, and cyclic olefin copolymers are mentioned. Among them, because of easy molding and heat resistance, polypropylene, cyclic olefin polymers, cyclic olefin copolymers Such resins are preferred.
  • cyclic Olefin copolymers are particularly preferred.
  • the prefilled syringe 20 of the present invention includes an outer cylinder 21 with a puncture part, a gasket 25 slidably accommodated in the outer cylinder 21 with a puncture part, a medicine 27 filled in the outer cylinder 21 with a puncture part, And a pusher 26 attached to or attachable to the proximal end of the gasket 25.
  • the prefilled syringe 20 of this embodiment uses the above-described outer cylinder 21 with a puncture unit, and further includes a seal cap 80 that seals the outer cylinder 21 with a puncture unit in a liquid-tight manner.
  • the outer cylinder with puncture portion 21 is as described above.
  • the gasket 25 includes a main body portion extending with substantially the same outer diameter, and a plurality of annular ribs provided on the main body portion (in this embodiment, two, two or more liquid-tight These ribs are in fluid-tight contact with the inner surface of the outer cylinder 21.
  • the front end surface of the gasket 25 is formed in the shape of the inner surface of the front end of the main body portion 23 of the outer tube 21 with a puncture portion so as not to form a gap as much as possible when contacting the inner surface of the outer tube 21 with the puncture portion. It has a corresponding shape.
  • the material for forming the gasket 25 examples include elastic rubber (eg, butyl rubber, latex rubber, silicone rubber), synthetic resin (eg, styrene elastomer such as SBS elastomer and SEBS elastomer, ethylene- ⁇ olefin copolymer). It is preferable to use a polyolefin-based elastomer or the like.
  • the gasket 25 is provided with a recess extending inward from the base end portion, and a plunger mounting portion is provided in the recess.
  • the plunger mounting portion is constituted by, for example, a female screw portion.
  • the pusher (plunger) 26 includes a main body part extending in the axial direction having a cross-shaped cross section, a gasket mounting part protruding from the main body part, and a pressing disk part 29 provided at the base end part.
  • the gasket mounting portion is formed by, for example, a protruding portion and a male screw portion formed on the outer surface thereof. The pusher 26 is not attached and may be attached at the time of use.
  • Examples of the medical liquid 27 filled in the prefilled syringe 20 include a solution or diluent such as water for injection, physiological saline, and aqueous glucose solution, and a drug (for example, vitamin, mineral, cyclosporine, benzodiazepine drug). , Sodium chloride injection solution, antibiotics, protein preparation), and a chemical solution capable of dissolving or diluting the powder preparation in the drug container.
  • a solution or diluent such as water for injection, physiological saline, and aqueous glucose solution
  • a drug for example, vitamin, mineral, cyclosporine, benzodiazepine drug.
  • Sodium chloride injection solution antibiotics, protein preparation
  • a chemical solution capable of dissolving or diluting the powder preparation in the drug container.
  • the seal cap 80 of this embodiment has a closed distal end portion 81, an opening proximal end portion 82, and a puncture portion storage portion 88 that stores the hollow portion 33 of the outer tube 21 with a puncture portion.
  • the puncture portion storage portion 88 stores the tip storage portion 84 that stores the puncture end portion 32 and the hollow portion 33 of the puncture portion 22 and seals the side holes 37 a provided in the hollow portion 33.
  • a portion 83, a large-diameter portion accommodating portion that accommodates the large-diameter portion 34, a locking portion 86 that engages with the stepped portion 35a, and a base end portion 87 that is expanded in diameter are provided.
  • the seal cap 80 When the seal cap 80 is attached to the hollow portion 33 of the outer cylinder 21 with the puncture portion, the side hole 37a of the hollow portion 33 is sealed by the sealing portion 83 and is in close contact with the step portion 35a. The part 86 is engaged and brought into close contact.
  • the seal cap 80 includes a locking portion 86 that protrudes in an annular shape and is provided on the inner surface located on the distal end side of the predetermined length from the opening base end portion 82.
  • the locking part 86 protrudes from the apex part toward the front end part, a rear side inclined part (taper part) in which the projecting height gradually decreases from the apex part toward the opening base end part, and protrudes from the apex part toward the distal end. It has a front side inclined portion (tapered portion) whose height gradually decreases.
  • the sealing portion 83 that houses the hollow portion 33 and seals the side hole 37 a provided in the small diameter portion 33 is substantially equal to or slightly equal to the outer diameter of the hollow portion 33. It has a small inner diameter and a cylindrical inner surface extending in the predetermined long axis direction.
  • the sealing part 83 may have a protrusion of a size that fits into the side hole 37a. This protrusion has an effect of preventing leakage of liquid from the side hole 37a.
  • the hollow portion 33 of the outer cylinder 21 with puncture portion does not advance any more in a state where the step portion 35a of the outer cylinder 21 with puncture portion and the engaging portion 86 of the seal cap 80 are engaged. It has become. Further, the puncture end 32 a of the puncture end portion 32 of the hollow portion 33 does not reach the distal end surface of the distal end storage portion 84 in a state where the stepped portion 35 a and the locking portion 86 are engaged.
  • the puncture portion storage portion 88 is formed of an elastic material into which a puncture needle can be inserted.
  • elastic materials that can be inserted into the puncture needle include rubbers such as butyl rubber, isoprene rubber, latex rubber and silicone rubber, styrene elastomers such as SBS elastomer and SEBS elastomer, and ethylene- ⁇ -olefin co-polymers.
  • An elastomer such as an olefin elastomer such as a polymer elastomer is preferred.
  • Example 1 A medical resin hollow needle (Example 1) having the form shown in FIGS. 1 to 6 was prepared using polycarbonate resin as a forming material.
  • the inner diameter of the hollow part provided with the side hole was 0.8 mm
  • the outer diameter was 2.0 mm
  • the thickness at the side hole part was 0.6 mm.
  • the side hole has a rectangular shape that is long in the axial direction in the hollow portion, the axial length is 1.0 mm
  • the radial length is 0.5 mm
  • the side wall has a distal end wall and a proximal end.
  • the inclination angle of the wall with respect to the distal end side of the central axis of the hollow needle was 135 °.
  • Comparative Example 1 A polycarbonate resin was used as a forming material, and a medical resin hollow needle (Comparative 1) having a form shown in FIGS.
  • the inner diameter of the hollow portion provided with the side hole was 0.8 mm
  • the outer diameter was 2.0 mm
  • the thickness at the side hole portion was 0.6 mm.
  • the side hole has a rectangular shape that is long in the axial direction in the hollow portion, the axial length is 2.4 mm
  • the radial length is 0.6 mm
  • the side wall has a distal end wall and a proximal end.
  • the inclination angle of the wall with respect to the tip end side of the central axis of the hollow needle was 90 °.
  • Example 1 The resin hollow needle of Example 1 was connected to a 1 mL syringe filled with 500 ⁇ L of water, the pusher was pressed firmly, and the injection angle of the liquid flow flowing out from the side hole was measured.
  • the liquid flow was ejected obliquely backward from the side hole, and the angle of the central axis of the syringe with respect to the distal end side was about 135 degrees.
  • the injection angle of the liquid flow flowing out from the side hole was measured.
  • the liquid flow was injecting diagonally forward from the side hole, and the angle with respect to the front end side of the center axis
  • the medical resin hollow needle of the present invention is as follows. (1) A medical resin hollow needle having a puncture portion at a distal end and a luer taper nozzle of a medical device and a hub portion attachable to a proximal end,
  • the puncture portion includes a puncture end portion having a solid puncture end that is tapered toward the tip, and a hollow portion that is continuous with the puncture end portion and extends to the proximal end side,
  • the hollow portion has a lumen communicating with the inside of the hub portion, and a side hole penetrating the side wall of the hollow portion and communicating the lumen and the outside, and the side hole on the side of the puncture end portion
  • the distal wall is a medical resin hollow needle extending in the proximal direction from the lumen toward the outside.
  • the flush liquid is side by side in the punctured port. It ejects slightly from the hole in the proximal direction. For this reason, the flush liquid also flows to the base end side from the side hole portion where retention is likely to occur even after flushing, so the flush liquid can be satisfactorily filled in the port without forming a retention portion such as a chemical solution or blood in the port. Can be substituted. Further, in the flushing operation, an operation of rotating the hollow needle is unnecessary, and liquid leakage due to expansion of the puncture hole of the port rubber plug after the hollow needle is removed from the port does not occur.
  • the above embodiment may be as follows.
  • the tip of the outer opening of the side hole is located 0.03 to 1.3 mm proximal to the tip of the inner opening of the side hole.
  • the medical device set of the present invention is as follows. (9) A medical device set comprising the medical resin hollow needle according to any one of (1) to (8), and a medical device,
  • the medical device includes a cylindrical outer cylinder main body, an outer cylinder provided at a distal end portion of the outer cylinder main body, and the Luer taper nozzle having a distal end opening, and is slidable in the outer cylinder.
  • a medical device set which is a prefilled syringe comprising:
  • this medical device set includes the above-described medical resin hollow needle, the liquid can be satisfactorily flushed and the liquid is caused by expansion of the puncture hole of the port rubber plug after the hollow needle is removed from the port. There is no leakage.
  • the outer cylinder with a puncture part of this invention is the following.
  • An outer cylinder with a puncture portion comprising a cylindrical outer cylinder main body portion and a puncture portion provided at a distal end portion of the outer cylinder main body portion,
  • the puncture portion includes a puncture end portion having a solid puncture end that is tapered toward the tip, and a hollow portion that is continuous with the puncture end portion and extends to the proximal end side,
  • the hollow portion has a lumen and a side hole that penetrates the side wall of the hollow portion and communicates the lumen with the outside, and the distal end wall of the side hole on the puncture end portion side is the inner wall.
  • An outer cylinder with a puncture portion extending in the proximal direction from the cavity toward the outside.
  • the puncture end side portion of the side hole extends in the proximal direction of the hollow portion, so that the flush liquid is slightly proximal to the side hole in the punctured port. Erupts. For this reason, the flush liquid also flows to the base end side from the side hole portion where retention is likely to occur even after flushing, so the flush liquid can be satisfactorily filled in the port without forming a retention portion such as a chemical solution or blood in the port. Can be substituted. Further, in the flushing operation, an operation of rotating the hollow needle is unnecessary, and liquid leakage due to expansion of the puncture hole of the port rubber plug after the hollow needle is removed from the port does not occur.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention concerne une aiguille creuse en résine médicale 1 comprenant une partie de ponction 10 au niveau d'une extrémité distale de celle-ci, et étant munie d'une partie d'embase 5 pouvant être montée sur une buse conique Luer d'un instrument médical au niveau d'une extrémité proximale de celui-ci. La partie de ponction 10 est munie d'une partie d'extrémité de ponction 2 ayant une extrémité de ponction solide 2a réduite en diamètre selon une forme conique vers l'extrémité distale de celle-ci, et une partie creuse 3 continue avec la partie d'extrémité de ponction 2 et s'étendant vers l'extrémité proximale. La partie creuse 3 a un alésage 11 en communication avec l'intérieur de la partie d'embase 5, et des trous latéraux 7a, 7b pénétrant à travers une paroi latérale de la partie creuse 3 qui sont en communication avec l'extérieur de l'alésage 11, et des parois d'extrémité distale 71 (parties sur des côtés de partie d'extrémité de ponction) sur des côtés de partie d'extrémité de ponction 2 des trous latéraux 7a, 7b s'étendent dans une direction d'extrémité proximale depuis l'alésage vers l'extérieur.
PCT/JP2016/078653 2015-09-29 2016-09-28 Aiguille creuse en résine médicale, ensemble d'instrumentation médicale l'utilisant, et cylindre externe muni d'une pièce de ponction Ceased WO2017057476A1 (fr)

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JP2017543497A JPWO2017057476A1 (ja) 2015-09-29 2016-09-28 医療用樹脂製中空針、それを用いた医療用具セットおよび穿刺部付外筒

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Cited By (6)

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Publication number Priority date Publication date Assignee Title
WO2022181527A1 (fr) * 2021-02-25 2022-09-01 株式会社狭山金型製作所 Tube d'aiguille, ensemble tube d'aiguille et aiguille à injection
JP2023542974A (ja) * 2020-09-23 2023-10-12 ベクトン・ディキンソン・アンド・カンパニー バイアルアダプタのためのカニューレ
WO2024142545A1 (fr) * 2022-12-27 2024-07-04 テルモ株式会社 Dispositif médical
WO2024157594A1 (fr) * 2023-01-23 2024-08-02 テルモ株式会社 Dispositif médical
US12357538B1 (en) 2024-11-25 2025-07-15 Genzyme Corporation Vial adapter and injection kit for withdrawing a liquid medicament from an injection vial
US12357539B1 (en) 2024-05-16 2025-07-15 Genzyme Corporation Vial adapter and injection kit for withdrawing a liquid medicament from an injection vial

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JPS62194347U (fr) * 1986-05-30 1987-12-10
JP2008149500A (ja) * 2006-12-15 2008-07-03 Nippon Sherwood Medical Industries Ltd カニューレの成形用金型および成形方法

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JP3883527B2 (ja) * 2003-07-17 2007-02-21 ニプロ株式会社 トランスファーニードル
US20070078429A1 (en) * 2005-06-15 2007-04-05 Inviro Medical Devices Ltd. Safety fluid transfer cannula
JP4787647B2 (ja) * 2005-09-06 2011-10-05 テルモ株式会社 医療用容器への薬剤混注器具

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JPS62194347U (fr) * 1986-05-30 1987-12-10
JP2008149500A (ja) * 2006-12-15 2008-07-03 Nippon Sherwood Medical Industries Ltd カニューレの成形用金型および成形方法

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023542974A (ja) * 2020-09-23 2023-10-12 ベクトン・ディキンソン・アンド・カンパニー バイアルアダプタのためのカニューレ
WO2022181527A1 (fr) * 2021-02-25 2022-09-01 株式会社狭山金型製作所 Tube d'aiguille, ensemble tube d'aiguille et aiguille à injection
JPWO2022181527A1 (fr) * 2021-02-25 2022-09-01
WO2024142545A1 (fr) * 2022-12-27 2024-07-04 テルモ株式会社 Dispositif médical
WO2024157594A1 (fr) * 2023-01-23 2024-08-02 テルモ株式会社 Dispositif médical
US12357539B1 (en) 2024-05-16 2025-07-15 Genzyme Corporation Vial adapter and injection kit for withdrawing a liquid medicament from an injection vial
US12357538B1 (en) 2024-11-25 2025-07-15 Genzyme Corporation Vial adapter and injection kit for withdrawing a liquid medicament from an injection vial

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