WO2023120550A1 - Crampon - Google Patents

Crampon Download PDF

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Publication number
WO2023120550A1
WO2023120550A1 PCT/JP2022/046999 JP2022046999W WO2023120550A1 WO 2023120550 A1 WO2023120550 A1 WO 2023120550A1 JP 2022046999 W JP2022046999 W JP 2022046999W WO 2023120550 A1 WO2023120550 A1 WO 2023120550A1
Authority
WO
WIPO (PCT)
Prior art keywords
air passage
needle tip
circular
needle
liquid passage
Prior art date
Application number
PCT/JP2022/046999
Other languages
English (en)
Japanese (ja)
Inventor
大輔 藤井
Original Assignee
ニプロ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ニプロ株式会社 filed Critical ニプロ株式会社
Publication of WO2023120550A1 publication Critical patent/WO2023120550A1/fr

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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

Definitions

  • This disclosure relates to bottle needles.
  • a plastic needle called a bottle needle is used to connect the container containing the drug solution used for infusion etc. to the tube of the infusion set.
  • Bottle needles are required to have a shape and strength that allow them to smoothly pierce an elastomer stopper attached to the mouth of a drug solution container, and to ensure a sufficient flow rate.
  • the bottle needle In which not only a liquid passage through which a liquid medicine flows but also an air passage through which air is supplied is formed inside.
  • the air passage it is preferable that the air passage extends closer to the needle tip than the liquid passage in order to prevent air from flowing into the liquid passage.
  • the bottle needle has a complex shape in which the vent path extends to the tip of the needle and has a region in which the vent path and the liquid passage extend in parallel (see, for example, Patent Document 1).
  • the molding pin will also become thin, so the molding pin will be bent and easily shaken by the resin pressure, the molding accuracy will decrease, and the short circuit will be more likely to occur.
  • the elongated molding pin is easily bent and shakes when inserted into the mold cavity. If the molding pin bends and contacts the inner wall of the cavity, the inner wall of the cavity is damaged or the molding pin is worn.
  • An object of the present disclosure is to solve at least one of various problems that occur when molding bottle needles, and to facilitate molding of highly reliable bottle needles.
  • a first aspect of the bottle needle of the present disclosure includes a needle tip portion formed on the distal end side, a connecting portion provided on the proximal end side, and an intermediate portion formed between the needle tip portion and the connecting portion. , a branched tubular portion that branches and protrudes from the intermediate portion, a passage that connects the tip opening of the liquid passage formed in the needle tip portion, and the base end opening of the liquid passage formed in the connecting portion.
  • the vent channel has a non-circular portion with a non-circular cross-section, and has a tapered shape in which the cross-sectional area gradually decreases from the distal end to the proximal end.
  • the cross section of the non-circular portion is such that the maximum length in the direction along the line connecting the center of the air passage and the center of the liquid passage is the center of the air passage and the center of the liquid passage. can be shorter than the maximum width in the direction orthogonal to the line connecting the With such a configuration, it becomes easy to secure the thickness of the partition wall between the liquid passage and the outer wall on the side opposite to the liquid passage.
  • the air passage has a distal circular portion formed on the distal side of the non-circular portion and a proximal circular portion formed on the proximal side of the non-circular portion. It can be configured to have a part. Since the vent channel has a tapered shape that narrows toward the proximal end, the circular portion on the distal end side and the circular portion on the proximal end side are provided with a draft angle, and the entire vent channel is formed of non-circular portions. Releasability is improved as compared with the case where it is formed. Furthermore, the tapered portion of the forming pin can have a large cross-sectional area to reduce deflection.
  • the bottle needle may have a gate mark at the time of molding in the connecting portion or the intermediate portion. With such a configuration, unevenness of the gate marks does not occur at the tip of the needle, so that puncturing can be performed smoothly.
  • the proximal end of the needle tip portion has a smaller diameter than the distal end of the intermediate portion, and the proximal end of the needle tip portion and the distal end of the intermediate portion are radially inwardly convex tips.
  • the side curved surface may be smoothly connected to the proximal side curved surface that is convex radially outward.
  • a second aspect of the bottle needle of the present disclosure includes a needle tip portion formed on the distal end side, a connecting portion provided on the proximal end side, and an intermediate portion formed between the needle tip portion and the connecting portion. and a branched tubular portion that branches and protrudes from the intermediate portion. and a branch cylinder flange formed between the valve body housing part, the thickness of the base being thinner than the thickness of the valve body housing part and matching the thickness of the connection part, and the base and the branch cylinder The brim is smoothly connected by a curved surface.
  • the thickness of the base is thinner than the thickness of the valve housing portion and matches the thickness of the connecting portion. Therefore, even if the resin pressure is not increased at the time of molding, the resin can smoothly flow into both the branch tube portion and the needle tip portion, thereby improving the molding accuracy. On the other hand, since the base portion and the branched cylinder brim portion are smoothly connected by the curved surface, a sufficient thickness can be secured in the valve housing portion.
  • the bottle needle of the present disclosure since the molding accuracy is improved, a highly reliable bottle needle can be realized.
  • FIG. 3 is a cross-sectional view taken along line IV-IV of FIG. 2;
  • FIG. 3 is a cross-sectional view taken along line VV of FIG. 2;
  • FIG. 3 is a cross-sectional view taken along line VI-VI of FIG. 2;
  • FIG. 3 is a cross-sectional view taken along line VII-VII of FIG. 2;
  • FIG. 3 is a cross-sectional view taken along line VIII-VIII of FIG. 2;
  • It is sectional drawing which expands and shows a branch cylinder part and a connection part.
  • the bottle needle of one embodiment has a bottle needle main body 101 including a main tube portion 111 and a branch tube portion 112 protruding sideways from the main tube portion 111.
  • the main cylinder portion 111 has a needle tip portion 121 provided on the distal end side, a connection portion 123 provided on the base end side, and an intermediate portion 122 formed between the needle tip portion 121 and the connection portion 123 . are doing.
  • Bottle needles are often used with the tip portion 121 up and the connection portion 123 down. , the direction in which the branch tube portion 112 protrudes is the top, and the opposite side is the bottom.
  • the needle tip portion 121 has a needle shape that gradually decreases in diameter toward the sharp tip, and can pierce a rubber stopper or the like provided in the drug solution container.
  • a tip opening 133 of a liquid passage and a tip opening 134 of an air passage are formed in the needle tip portion 121 .
  • the air passage tip opening 134 is located on the tip side of the liquid passage tip opening 133 .
  • the connecting portion 123 has a tapered shape with a slightly reduced diameter toward the base end side, and can be connected to a tube or the like.
  • a liquid passage proximal end opening 137 is opened at the proximal end of the connecting portion 123 .
  • the intermediate portion 122 is formed to have a larger diameter than the needle tip portion 121 and the connecting portion 123, and the branched tubular portion 112 protrudes upward.
  • An air passage base end opening 138 is opened at the upper end of the branched tubular portion 112 .
  • a liquid passage 131 and an air passage 132 are formed in the main cylindrical portion 111 .
  • the liquid passage 131 connects the liquid passage distal end opening 133 and the liquid passage proximal end opening 137 .
  • the air passage 132 connects a front end opening 134 of the air passage and a base end opening 138 of the air passage through the lumen 112a of the branch tubular portion.
  • the liquid passage 131 and the air passage 132 are formed in parallel in at least part of the needle tip portion 121 and the intermediate portion 122 . Since the air passage 132 is connected to the lumen 112 a of the tubular branch portion 112 , it is formed above the liquid passage 131 (on the side of the tubular branch portion 112 ).
  • a large-diameter portion 131b having a larger inner diameter than the small-diameter portion 131a on the distal end side is formed on the base end side of the liquid passage 131, and the small-diameter portion 131a and the large-diameter portion 131b are connected by an enlarged diameter portion 131c.
  • the central axis of the small-diameter portion 131a on the distal end side is located below the central axis of the large-diameter portion 131b, and the enlarged-diameter portion 131c is asymmetrically enlarged in diameter, and is located above the lower portion. It has a wider shape.
  • the air passage 132 excluding the portion of the lumen 112a of the branch tube portion, is formed in a tapered shape in which the cross-sectional area gradually decreases from the distal end side to the base end side (the branch tube portion side). This is a configuration for allowing a molding pin for molding the air passage 132 to come out to the tip side.
  • the air passage 132 has a non-circular portion 132a with a non-circular cross section.
  • the cross-sectional area of the non-circular portion 132a also gradually decreases from the distal end side to the proximal end side.
  • the maximum height d1 in the direction (vertical direction) connecting the center of the air passage 132 and the center of the liquid passage 131 is equal to the center of the air passage 132 and the liquid passage. It is smaller than the maximum width d2 in the direction (width direction) crossing the direction connecting the center of 131 .
  • the connection between the ventilation passage 132 and the liquid passage 131 is reduced. It becomes easy to increase the thickness t1 of the partition wall between them and the thickness t2 of the outer wall of the air passage 132 on the side opposite to the liquid passage 131 .
  • the cross-sectional area of the air passage 132 and the cross-sectional area of the molding pin for forming the air passage 132 can be increased compared to the case of forming a circular air passage having a diameter equal to d1.
  • a molding pin When forming the air passage 132, a molding pin is inserted from the tip side into a narrow cavity that forms the main cylindrical portion of the mold. If the molding pin is shaken while being inserted, it abuts against the inner wall of the cavity, resulting in wear of the molding pin or damage to the inner wall of the cavity. Further, if the molding pin is shaken due to resin pressure during molding, the air passage 132 will be distorted, and in the worst case, it will short-circuit with the liquid passage 131 .
  • the cross-sectional area of the molding pin can be increased compared to the case of forming a circular air passage having a diameter equal to d1, so that the bending of the molding pin can be reduced to prevent blurring. can be suppressed.
  • the cross section of the air passage 132 at the non-circular portion 132a is a circular shape with a cutout at the upper end.
  • the molded pin can be easily formed.
  • it is not limited to such a shape, and may be, for example, an elliptical shape, an elliptical shape, a semicircular shape, or any other shape in which d1 is smaller than d2.
  • the air passage 132 has a distal circular portion 132b on the distal side (needle tip portion side) of the non-circular portion 132a, and a proximal circular shape on the proximal side (branch tube portion side). It has a portion 132c.
  • the molded pin has a distal circular portion 132b on the distal side (needle tip portion side) of the non-circular portion 132a, and a proximal circular portion 132c on the proximal side (branch tube portion side).
  • a distal circular portion 132b and the proximal circular portion 132c are drafted, and the molding pin as a whole has a substantially conical shape.
  • a non-circular portion 132a having a straight surface formed by a notch is provided at a portion of the forming pin where it is particularly necessary to ensure the thickness of the partition wall or the outer wall of the bottle needle.
  • demerits related to molding such as scratches in the air passage 132 can be minimized.
  • the intermediate portion 122 is formed to have a diameter larger than that of the needle tip portion 121 . Therefore, in the intermediate portion 122, the thickness of the wall can be easily increased sufficiently.
  • the air passage 132 has a tapered shape with a diameter that gradually decreases toward the branch tube portion 112 , and the cross-sectional area of the intermediate portion 122 of the air passage 132 is smaller than the cross-sectional area of the needle tip portion 121 . Therefore, in the intermediate portion 122, the thickness of the partition wall and the outer wall can be ensured even if the cross-sectional shape of the air passage 132 is circular.
  • the boundary between the non-circular portion 132 a and the proximal circular portion 132 c coincides with the boundary between the needle tip portion 121 and the intermediate portion 122 .
  • the non-circular portion 132a can be configured to reach the intermediate portion 122 side
  • the proximal side circular portion 132c can be configured to extend toward the needle tip portion 122 side.
  • the entire air passage 132 can be formed as a non-circular portion without forming the distal circular portion 132b and the proximal circular portion 132c. In this case, notch processing becomes easier than in the case of forming a notch in a part.
  • only one of the distal circular portion 132b and the proximal circular portion 132c may be formed. These can be appropriately changed in consideration of the thickness of each wall, the area of the liquid passage/ventilation path, and the strength of the bottle needle.
  • the liquid passage 131 is tapered such that the cross-sectional area gradually decreases from the proximal side to the distal side. Moreover, the liquid passage 131 also has a cut-out circle-shaped cross section with a notched upper end. By making the cross-sectional shape of the liquid passage 131 a circular shape, it becomes easier to increase the thickness of the partition wall between the air passage 132 and the liquid passage 131 .
  • the intermediate portion 122 has a flange portion 151 protruding radially outward. Forming the flange 151 facilitates gripping of the bottle needle and improves operability. Further, in this embodiment, as shown in FIG. 9, gates for molding are provided on both sides of the brim portion 151 . By positioning the gate at the brim portion 151 , it is possible to prevent gate traces from being formed on the outer surface of the needle tip portion 121 . In the case of this embodiment, a recessed seat 152 is formed on the side surface of the distal end of the brim-shaped portion 151, and the center of the recessed seat serves as a gate.
  • the gate at the time of molding is not limited to the brim portion 151, but is preferably located at a portion other than the needlepoint portion 121.
  • the branch tubular portion 112 includes a base portion 125 connected to the intermediate portion 122, a valve housing portion 126 on the opposite side of the base portion, and a branching portion formed between the base portion 125 and the valve housing portion 126. It has a cylindrical collar portion 127 .
  • a check valve and a filter can be arranged in the lumen 112a of the branch tube portion 112 .
  • a cap can be attached to the valve housing portion 126 to block the air passage. By forming the branched cylinder flange portion 127, attachment of the cap can be facilitated.
  • the resin injected from the gate must flow smoothly. It is preferable to flow toward the needle tip portion 121 side.
  • the resin pressure may not be increased beyond the branch tube portion 112 and the needle tip side may not reach the needle tip side unless the resin pressure is increased. is difficult to flow.
  • the resin pressure is increased, the molding accuracy of the needle tip portion 121 is lowered, and burrs are likely to occur.
  • the branch tube portion 112 By making the branch tube portion 112 thin, the resin can easily flow toward the needle tip portion 121 without increasing the resin pressure. is necessary, and it is difficult to make the entire branch tubular portion 112 thin.
  • the branch tube portion 112 has the required strength.
  • the thickness t4 of the valve body accommodating portion 126 is thicker than the thickness t3 of the base portion 125, it becomes difficult for the resin to flow uniformly where the thickness changes.
  • the curved surface 128 smoothly connects the base 125 and the lower surface of the branched cylinder flange 127, thereby facilitating the uniform flow of the resin.
  • the thickness t4 of the valve housing portion 126 is preferably about 1.5 to 2.0 times the thickness t3 of the base portion 125.
  • the thickness t3 of the base portion 125 is made equal to the thickness t5 of the connection portion 123 .
  • the resin injected from the gate flows to the branch tube portion 112 and the connecting portion 123 in a well-balanced manner, so that the molding accuracy of the bottle needle as a whole is improved.
  • a difference of about ⁇ 10% between the thickness t3 of the base portion 125 and the thickness t5 of the connecting portion 123 can be allowed.
  • the intermediate portion 122 and the needle tip portion 121 are smoothly connected by the boundary portion 155 .
  • the boundary portion 155 is formed by combining two curved surfaces.
  • the curved surface on the side of the tip portion 121 is convex radially inward, and the curved surface on the side of the intermediate portion 122 is convex radially outward.
  • Intermediate portion 122 and tip portion 121 are smoothly connected by boundary portion 155, which is a combination of two curved surfaces, so that tip portion 121 is less likely to break.
  • the bottle needle of the example and the bottle needle of the comparative example were the same in shape, material, etc., other than the shape of the connecting portion.
  • a weight of 250 g is dropped from a predetermined height onto the tip of the needle while the flange is fixed and supported so that the tip of the needle protrudes horizontally, and whether the tip breaks. was measured.
  • the bottle needles of the examples did not break until the weight was dropped from a height of 130 mm, regardless of whether the weight was colliding with the top surface, the bottom surface, or the side surface.
  • the bottle needle of the comparative example broke at a height of 110 mm when the weight was struck from any direction.
  • the bottle needle of the present disclosure is highly reliable and useful in the medical field and the like.

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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)

Abstract

L'invention concerne un crampon comprenant : une unité cylindrique principale (111) ayant une section de pointe d'aiguille (121), une section de liaison (123) et une section intermédiaire (122) ; une unité cylindrique de ramification (112) qui fait saillie par ramification hors de la section intermédiaire (122) ; un passage de liquide (131) qui relie une ouverture distale de passage de liquide (133), formée dans la section de pointe d'aiguille (121), à une ouverture proximale de passage de liquide (135), formée dans la section de liaison 123) ; et un passage d'air (132) qui relie une ouverture distale de passage d'air (137), formée dans la pointe d'aiguille (121), à une ouverture proximale de passage d'air (138), formée dans l'unité cylindrique de ramification (112). Le passage d'air (132) comprend une section de forme non circulaire (132a) ayant une section transversale non circulaire. Le passage d'air présente une forme effilée dans laquelle la surface de section transversale est progressivement réduite du côté distal vers le côté proximal.
PCT/JP2022/046999 2021-12-24 2022-12-21 Crampon WO2023120550A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2021210725 2021-12-24
JP2021-210725 2021-12-24

Publications (1)

Publication Number Publication Date
WO2023120550A1 true WO2023120550A1 (fr) 2023-06-29

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PCT/JP2022/046999 WO2023120550A1 (fr) 2021-12-24 2022-12-21 Crampon

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WO (1) WO2023120550A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010061743A1 (fr) * 2008-11-25 2010-06-03 株式会社ジェイ・エム・エス Connecteur
WO2012132286A1 (fr) * 2011-03-31 2012-10-04 パナソニック株式会社 Aiguille pour la perfusion de médicament et procédé de perfusion de médicament
JP2014513995A (ja) * 2011-02-08 2014-06-19 カルメル ファルマ アクチボラゲット 結合デバイスおよびそのキット
WO2020168175A1 (fr) * 2019-02-15 2020-08-20 Yukon Medical, Llc Dispositif de transfert destiné à être utilisé avec un contenant de liquide de perfusion
JP2021520267A (ja) * 2018-04-10 2021-08-19 ベクトン ディキンソン アンド カンパニー リミテッド Ｄｖｏの最後の一滴の引出しを目的とする、フラッシュを備えたプラスチックスパイクを収容するプロテクタ

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010061743A1 (fr) * 2008-11-25 2010-06-03 株式会社ジェイ・エム・エス Connecteur
JP2014513995A (ja) * 2011-02-08 2014-06-19 カルメル ファルマ アクチボラゲット 結合デバイスおよびそのキット
WO2012132286A1 (fr) * 2011-03-31 2012-10-04 パナソニック株式会社 Aiguille pour la perfusion de médicament et procédé de perfusion de médicament
JP2021520267A (ja) * 2018-04-10 2021-08-19 ベクトン ディキンソン アンド カンパニー リミテッド Ｄｖｏの最後の一滴の引出しを目的とする、フラッシュを備えたプラスチックスパイクを収容するプロテクタ
WO2020168175A1 (fr) * 2019-02-15 2020-08-20 Yukon Medical, Llc Dispositif de transfert destiné à être utilisé avec un contenant de liquide de perfusion

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