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WO2013141137A1 - Aiguille de bouteille pourvue d'un couvercle - Google Patents

Aiguille de bouteille pourvue d'un couvercle Download PDF

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Publication number
WO2013141137A1
WO2013141137A1 PCT/JP2013/057216 JP2013057216W WO2013141137A1 WO 2013141137 A1 WO2013141137 A1 WO 2013141137A1 JP 2013057216 W JP2013057216 W JP 2013057216W WO 2013141137 A1 WO2013141137 A1 WO 2013141137A1
Authority
WO
WIPO (PCT)
Prior art keywords
bottle needle
central axis
cover
outer peripheral
head
Prior art date
Application number
PCT/JP2013/057216
Other languages
English (en)
Japanese (ja)
Inventor
立▲崎▼斉
沖山忠
Original Assignee
株式会社ジェイ・エム・エス
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 株式会社ジェイ・エム・エス filed Critical 株式会社ジェイ・エム・エス
Publication of WO2013141137A1 publication Critical patent/WO2013141137A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M5/31—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
    • A61M5/329—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 characterised by features of the needle shaft
    • 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
    • A61M5/329—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 characterised by features of the needle shaft
    • A61M5/3291—Shafts with additional lateral openings

Definitions

  • the present invention relates to a bottle needle with a cover in which a cover is attached to a bottle needle (sometimes referred to as a resin needle or a puncture needle) that is pierced into a rubber stopper such as a vial bottle.
  • a bottle needle sometimes referred to as a resin needle or a puncture needle
  • Patent Documents 1 and 2 describe connectors that enable this series of operations to be performed efficiently.
  • the connector is connected to a vial bottle, a chemical solution bag, and a syringe for moving a liquid between them.
  • the connector is provided with a cock for switching the flow path between these three. By operating the cock to push and pull the syringe in a state where an appropriate flow path is formed, the liquid can be moved between the vial and the drug solution bag via the syringe.
  • the connector and the chemical solution bag are communicated by slip-connecting a male luer provided in the connector and a needleless port provided in the chemical solution bag.
  • the needleless port includes a partition member (hereinafter referred to as “septum”) made of an elastic material such as rubber and having a linear slit (cut) formed at the center.
  • the connector and the vial are communicated by piercing the rubber stopper of the vial with a bottle needle provided in the connector.
  • Some drugs are designated as powerful drugs, such as some anticancer drugs. It is necessary to avoid a situation in which a chemical solution containing such a dangerous drug leaks out and adheres to an operator's finger or the like, or the operator sucks the vapor.
  • Patent Documents 1 and 2 described above a method of covering the male luer with a cover that can be compressed and deformed is described in order to prevent liquid from leaking out from the male luer that is not connected to the needleless port.
  • a linear slit (cut) is formed at a position facing the tip of the male luer of the cover.
  • the bottle needle that is pierced into the rubber stopper of the vial is used to reduce the change in the atmospheric pressure in the vial.
  • a gas flow path is formed for communicating the.
  • the bottle needle punctured in the rubber stopper is pulled out from the rubber stopper. Liquid tends to remain in the vicinity of the opening of the liquid channel.
  • An object of the present invention is to prevent liquid from leaking from the bottle needle to the outside world.
  • the bottle needle with a cover includes a bottle needle having a sharp tip and a cover covering at least the tip of the bottle needle.
  • a liquid channel through which a liquid flows and a gas channel through which a gas flows are formed independently of each other along the longitudinal direction of the bottle needle.
  • a lateral hole communicating with the liquid channel opens on the outer peripheral surface of the bottle needle.
  • the cover has a substantially cylindrical shape and is elastically deformable in the longitudinal direction of the bottle needle, and is provided at one end of the outer peripheral wall.
  • a head penetrating the tip In a state where the outer peripheral wall is not compressed and deformed, the head portion of the cover closes the lateral hole opened in the outer peripheral surface of the bottle needle.
  • the possibility of liquid leaking from the bottle needle to the outside world can be reduced.
  • FIG. 1 is a cross-sectional view of a bottle needle with a cover according to Embodiment 1 of the present invention.
  • FIG. 2A is a perspective view of the bottle needle according to the first embodiment of the present invention as viewed from the opening side of the lateral hole communicating with the liquid channel.
  • FIG. 2B is a perspective view of the bottle needle according to the first embodiment of the present invention as seen from the opening side of the gas flow path.
  • FIG. 3A is a perspective view seen from above the cover according to the first embodiment of the present invention, and FIG. 3B is a perspective view seen from below.
  • FIG. 4A is a front view of a cover according to Embodiment 1 of the present invention, and FIG. 4B is a side view thereof.
  • FIG. 5A is a plan view of the cover according to the first embodiment of the present invention as viewed from the direction of the arrow 5A in FIG. 4A
  • FIG. 5B is the cover according to the first embodiment of the present invention as viewed from the direction of the arrow 5B in FIG. 4A
  • FIG. 6A is a cross-sectional view of the cover according to the first embodiment of the present invention taken along the plane including line 6A-6A in FIG. 4B
  • FIG. 6B is a cross-sectional view taken along the line 6B-6B in FIG. 4A. It is arrow sectional drawing of the cover concerning Embodiment 1.
  • FIG. 7A is a perspective view seen from below the cover according to the first embodiment of the present invention, cut along a horizontal plane passing through the first region of the first compression unit.
  • FIG. 7B is a perspective view seen from below the cover according to the first embodiment of the present invention, cut along a horizontal plane passing through the second region of the first compression unit.
  • FIG. 7C is a perspective view seen from below of the cover according to the first embodiment of the present invention, cut along a horizontal plane passing through the first region of the second compression unit.
  • FIG. 7D is a perspective view seen from below the cover according to the first embodiment of the present invention, cut along a horizontal plane passing through the second region of the second compression unit.
  • FIG. 8A and 8B are sectional views showing a state before the bottle needle with a cover according to the first embodiment of the present invention is punctured into the rubber stopper of the vial bottle.
  • 9A and 9B are cross-sectional views showing a state in which the bottle needle with the cover according to the first embodiment of the present invention is punctured into the rubber stopper of the vial bottle.
  • FIG. 10 is sectional drawing of the bottle needle with a cover concerning Embodiment 2 of this invention.
  • FIG. 11 is the perspective view seen from the upper direction of the cover concerning Embodiment 2 of this invention.
  • the head is formed with a lumen in which the tip of the bottle needle is stored.
  • the inner peripheral surface of the lumen is in close contact with the outer peripheral surface of the bottle needle to close the lateral hole in a state where the outer peripheral wall is not compressed and deformed.
  • a protruding convex portion is formed at the position of the tip of the head through which the bottle needle penetrates.
  • the outer peripheral wall of the cover includes a plurality of compression units arranged along a central axis direction (that is, a longitudinal direction of the bottle needle).
  • each of the plurality of compression units is preferably deformed by the compression force in the central axis direction.
  • N is an integer of 2 or more
  • each of the plurality of compression units has N thick portions formed at equiangular intervals with respect to the central axis, or N thin portions It is preferable that they are formed at equiangular intervals with respect to the central axis, or that both N thick portions and N thin portions are formed at equiangular intervals with respect to the central axis.
  • each of the plurality of compression units is preferably changed periodically in the circumferential direction. It is preferable that the phase of the periodic change in thickness is shifted with respect to the central axis between two compression units adjacent in the central axis direction. In such a preferable configuration, the portions that hardly deform when the compressive force is applied and the portions that greatly bend and deform are alternately formed in the circumferential direction of each compression unit. And between two adjacent compression units, these two different types of parts are substantially opposed in the central axis direction. Therefore, the possibility that the cover is buckled and deformed can be reduced.
  • the phase of the periodic change in thickness is shifted by 360 / 2N degrees with respect to the central axis between two compression units adjacent in the central axis direction.
  • Each of the N thick portions is preferably a rib-like convex portion extending in a direction parallel to the central axis direction.
  • each of the N thin-walled portions is preferably a groove-like recess extending in a direction parallel to the central axis direction.
  • the plurality of compression units have a substantially similar shape, and a plurality of compression units having different diameters are arranged such that the compression units farther from the head have larger diameters.
  • a substantially forward tapered cover whose diameter increases as it moves away from the head when viewed macroscopically. Therefore, the dimensional change amount of the entire cover when the compressive force is applied can be increased. Further, when the cover is molded using a mold, the mold can be easily removed, so that the moldability is improved.
  • At least one of the N thick parts and the N thin parts extends over the entire range in the central axis direction of the compression unit in which the N thick parts are formed.
  • the N thick parts are preferably formed on the outer surface of the outer peripheral wall. Thereby, a large space can be secured between the outer peripheral wall and the male member. Accordingly, when the outer peripheral wall is compressed and deformed, collision between the outer peripheral wall and the male member is less likely to occur, so that the dimensional change amount of the entire cover can be increased.
  • the N thin portions are formed on the inner surface of the outer peripheral wall. Therefore, a large space can be secured between the outer peripheral wall and the male member. Accordingly, when the outer peripheral wall is compressed and deformed, collision between the outer peripheral wall and the male member is less likely to occur, so that the dimensional change amount of the entire cover can be increased.
  • each of the plurality of compression units has a forward taper shape that is a forward taper surface whose diameter increases as the distance from the head increases.
  • a substantially forward tapered cover whose diameter increases as the distance from the head increases. Therefore, the dimensional change amount of the entire cover when the compressive force is applied can be increased. Further, when the cover is molded using a mold, the mold can be easily removed, so that the moldability is improved.
  • each of the plurality of compression units may have a cylindrical shape in which both the inner surface and the outer surface are cylindrical surfaces closer to the head side than the forward tapered shape. Accordingly, when the cover is molded using a mold, the mold can be easily removed, so that the moldability is improved.
  • each of the plurality of compression units has a reverse taper shape that is a reverse taper surface whose diameter decreases as the inner surface and the outer surface move away from the head, closer to the head side than the forward taper shape. It may be.
  • the cross-sectional shape of the outer peripheral wall along a plane perpendicular to the central axis at an arbitrary position on the central axis is preferably substantially circular.
  • FIG. 1 is a cross-sectional view of a bottle needle 1 with a cover according to Embodiment 1 of the present invention.
  • the bottle needle 1 with a cover includes a bottle needle 10 and a cover 100 attached to the bottle needle 10.
  • 1 a is the central axis of the bottle needle 10 and the cover 100.
  • FIG. 1 is a sectional view taken along a plane including the central axis 1a.
  • the direction of the central axis 1a is referred to as “vertical direction”
  • the side of the base material 19 is referred to as “lower side”
  • the opposite side is referred to as “upper side”.
  • a direction along a plane orthogonal to the central axis 1a is referred to as “horizontal direction”.
  • the “vertical direction” and “horizontal direction” do not mean the posture of the bottle needle 1 with cover in actual use.
  • the direction orthogonal to the central axis 1a is referred to as “radial direction”, and the direction of rotation around the central axis 1a is referred to as “circumferential direction”.
  • FIGS. 1, 2A, and 2B are perspective views of the bottle needle 10 viewed from different directions.
  • the bottle needle 10 is a rod-like member that protrudes from the base 19 and has a substantially conical surface (tapered surface) to form a sharp tip 10t.
  • a conical portion 15 having an outer surface and a columnar portion 16 that connects the conical portion 15 and the base 19 are provided.
  • the outer peripheral surface of the columnar portion 16 is a tapered surface whose outer diameter slightly decreases as it approaches the conical portion 15.
  • the taper angle of the outer peripheral surface of the cone portion 15 is smaller than the taper angle of the cone portion 15.
  • the shape of the outer peripheral surface of the bottle needle 10 is not limited to this, and can be arbitrarily configured.
  • the outer peripheral surface of the columnar portion 16 may be a cylindrical surface whose outer diameter is constant in the direction of the central axis 1a.
  • the outer peripheral surface of the columnar portion 16 is composed of two tapered surfaces having different taper angles, but is composed of a single tapered surface. It may be configured, or may be configured by arbitrarily combining a tapered surface and / or a cylindrical surface.
  • the outer peripheral surface of the bottle needle 10 does not need to be clearly distinguished from the conical portion 15 and the columnar portion 16, and is, for example, a curved surface whose outer diameter gradually changes as it approaches the base 19 from the tip 10t. It may be configured.
  • the channel 11 is a liquid channel through which liquid flows
  • the channel 12 is a gas channel through which gas flows.
  • the liquid flow path 11 communicates with the lateral hole 11a on the tip 10t side.
  • the lateral hole 11a extends along a direction orthogonal to the central axis 1a, and is open on the outer peripheral surface of the columnar portion 16 as shown in FIG. 2A.
  • the gas flow path 12 is opened in the outer peripheral surface of the cone part 15 as shown to FIG. 2B in the front-end
  • the base 19 may be a part of a connector (not shown) connected to a vial, for example.
  • the bottle needle 10 of the first embodiment can be used as the bottle needle of the connector described in Patent Documents 1 and 2.
  • the liquid channel 11 and the gas channel 12 are opened on the lower surface of the base 19, but may be extended to communicate with a desired channel.
  • the bottle needle 10 and the base 19 are preferably made of a hard material that can be regarded as a substantially rigid body.
  • the bottle needle 10 and the base 19 can be formed by a method such as integral molding using a resin material such as polyacetal or polycarbonate.
  • FIG. 3A is a perspective view of the cover 100 as viewed from above, and FIG. 3B is a perspective view of the cover 100 as viewed from below.
  • 4A is a front view of the cover 100
  • FIG. 4B is a side view of the cover 100
  • FIG. 5A is a plan view of the cover 100 viewed from the direction of arrow 5A in FIG. 4A
  • FIG. 5B is a cover 100 viewed from the direction of arrow 5B in FIG.
  • FIG. 6A is a cross-sectional view of the cover 100 taken along the line 6A-6A in FIG. 4B
  • FIG. 6B is a cross-sectional view of the cover 100 taken along the line 6B-6B in FIG. 4A. is there.
  • the cover 100 includes an outer peripheral wall 101 having a substantially cylindrical shape, a head 150 provided at one end of the outer peripheral wall 101, and an annular base 180 provided at the other end of the outer peripheral wall 101.
  • the cover 100 can be integrally formed of a rubber-like elastic material (also called an elastomer. For example, silicon rubber or isoprene rubber) having flexibility (softness).
  • the outer peripheral wall 101 When a compressive force in the vertical direction (the direction of the central axis 1a) is applied to the cover 100, the outer peripheral wall 101 is elastically compressed and deformed so that its vertical dimension is shortened.
  • the outer peripheral wall 101 includes a first compression unit 110 and a second compression unit 120 in this order from the head 150 side.
  • the first compression unit 110 will be described.
  • the first compression unit 110 includes a first region 111 and a second region 112 having different shapes on the outer surface (the surface opposite to the central axis 1a) and the inner surface (the surface facing the central axis 1a). Prepare in this order.
  • the outer surface 111a of the first region 111 is a cylindrical surface whose outer diameter is constant in the direction of the central axis 1a.
  • the inner surface 111b of the first region 111 is also a cylindrical surface whose inner diameter is constant in the direction of the central axis 1a. Accordingly, the first region 111 of the first embodiment has a cylindrical shape in which both the outer surface 111a and the inner surface 111b are cylindrical surfaces.
  • the outer surface 112a of the second region 112 has a tapered surface whose outer diameter increases as the distance from the head 150 increases. It is called “tapered surface”.
  • the inner surface 112b of the second region 112 is also a tapered surface (forward tapered surface) whose inner diameter increases as the distance from the head 150 increases. Accordingly, the second region 112 of the first embodiment has a forward tapered shape in which both the outer surface 112a and the inner surface 112b are forward tapered surfaces.
  • a pair of convex portions 113 projecting outward in the radial direction are formed at symmetrical positions with respect to the central axis 1a.
  • the convex portion 113 is a rib-shaped projection extending along a direction parallel to the central axis 1a.
  • the outer surface of the convex portion 113 (the surface opposite to the central axis 1a) is a cylindrical surface having the central axis 1a as the central axis.
  • the convex 113 extends from the upper end to the lower end of the first compression unit 110 over the entire range of the first compression unit 110 in the direction of the central axis 1a.
  • FIG. 7A is a perspective view seen from below the cover 100 cut along a horizontal plane (a plane orthogonal to the central axis 1a) passing through the first region 111 of the first compression unit 110.
  • FIG. FIG. 7B is a perspective view seen from below of the cover 100 cut along a horizontal plane passing through the second region 112 of the first compression unit 110.
  • the inner surface 112b of the second region 112 is formed with a pair of recesses 114 radially expanded outward in a symmetric position with respect to the central axis 1a.
  • the recess 114 is a groove-like recess extending along a direction parallel to the central axis 1a.
  • the bottom surface of the recess 114 (the surface facing the central axis 1a) is a conical surface having the central axis 1a as the central axis.
  • the recess 114 extends from the upper end to the lower end of the second region 112 over the entire range of the second region 112 in the direction of the central axis 1a.
  • the direction in which the pair of recesses 114 face each other is orthogonal to the direction in which the pair of protrusions 113 face each other.
  • the convex portions 113 and the concave portions 114 are alternately formed at equal angular intervals in the circumferential direction of the first pressure contact unit 110, so that the thickness of the first compression unit 110 (the dimension in the direction orthogonal to the central axis 1a) is obtained. ) Changes periodically in the circumferential direction. More specifically, the first region 111 has a constant thickness (basic thickness) in a region other than the convex portion 113, and is thicker than the basic thickness in the convex portion 113 (see FIG. 7A).
  • the second region 112 has a constant thickness (basic thickness) in regions other than the convex portion 113 and the concave portion 114, and is thicker than the basic thickness at the convex portion 113 and thinner than the basic thickness at the concave portion 114 (FIG. 7B). reference).
  • the convex part 113 comprises the thick part locally thickened
  • the recessed part 114 comprises the thin part locally thinned.
  • the second compression unit 120 will be described.
  • the second compression unit 120 includes a first region 121 and a second region 122 having different shapes on the outer surface (the surface opposite to the central axis 1a) and the inner surface (the surface facing the central axis 1a). Prepare in this order.
  • the outer surface 121a of the first region 121 is a cylindrical surface whose outer diameter is constant in the direction of the central axis 1a.
  • the inner surface 121b of the first region 121 is also a cylindrical surface whose inner diameter is constant in the direction of the central axis 1a. Accordingly, the first region 121 of the first embodiment has a cylindrical shape in which both the outer surface 121a and the inner surface 121b are cylindrical surfaces.
  • the outer surface 122a of the second region 122 is a tapered surface (forward tapered surface) whose outer diameter increases as the distance from the head 150 increases.
  • the inner surface 122b of the second region 122 is also a tapered surface (forward tapered surface) whose inner diameter increases as the distance from the head 150 increases. Accordingly, the second region 122 of the first embodiment has a forward tapered shape in which both the outer surface 122a and the inner surface 122b are forward tapered surfaces.
  • a pair of convex portions 123 projecting outward in the radial direction are formed at symmetrical positions with respect to the central axis 1a.
  • the convex portion 123 is a rib-like projection extending along a direction parallel to the central axis 1a.
  • the outer surface of the convex portion 123 (surface opposite to the central axis 1a) is a cylindrical surface having the central axis 1a as the central axis.
  • the convex 123 extends from the upper end to the lower end of the second compression unit 120 over the entire range of the second compression unit 120 in the direction of the central axis 1a.
  • FIG. 7C is a perspective view seen from below the cover 100 cut by a horizontal plane (a plane orthogonal to the central axis 1a) passing through the first region 121 of the second compression unit 120.
  • FIG. FIG. 7D is a perspective view of the cover 100 cut from a horizontal plane passing through the second region 122 of the second compression unit 120 as viewed from below.
  • the inner surface 122b of the second region 122 is formed with a pair of recesses 124 that are radially expanded outward in a symmetric position with respect to the central axis 1a.
  • the recess 124 is a groove-like recess extending along a direction parallel to the central axis 1a.
  • the bottom surface of the recess 124 (the surface facing the central axis 1a) is a conical surface having the central axis 1a as the central axis.
  • the recess 124 extends from the upper end to the lower end of the second region 122 over the entire range of the second region 122 in the direction of the central axis 1a.
  • the direction in which the pair of recesses 124 face each other is orthogonal to the direction in which the pair of protrusions 123 face each other.
  • the convex portions 123 and the concave portions 124 are alternately formed at equal angular intervals in the circumferential direction of the second compression unit 120, whereby the thickness of the second compression unit 120 (the dimension in the direction orthogonal to the central axis 1a). ) Changes periodically in the circumferential direction. More specifically, the first region 121 has a constant thickness (basic thickness) in regions other than the convex portion 123, and is thicker than the basic thickness in the convex portion 123 (see FIG. 7C).
  • the second region 122 has a constant thickness (basic thickness) in regions other than the convex portion 123 and the concave portion 124, and is thicker than the basic thickness at the convex portion 123 and thinner than the basic thickness at the concave portion 124 (FIG. 7D). reference).
  • the convex part 123 comprises the thick part locally thickened
  • the recessed part 124 comprises the thin part locally thinned.
  • the first compression unit 110 and the second compression unit 120 that are adjacent to each other have a relatively larger diameter (dimension) in the second compression unit 120, but their shapes are substantially the same. It is. However, the phase of the periodic change of the thickness along the circumferential direction is shifted by 90 degrees between the first compression unit 110 and the second compression unit 120. That is, when viewed along a direction parallel to the central axis 1 a, the position of the pair of thick portions (that is, the pair of convex portions 113) of the first compression unit 110 and the pair of thick portions of the second compression unit 120. That is, the position of the pair of convex portions 123 is different by 90 degrees with respect to the central axis 1a.
  • the position of the pair of thin portions (that is, the pair of recesses 114) of the first compression unit 110 and the pair of thin portions (that is, the pair of thin portions) of the second compression unit 120 (that is, The position of the pair of recesses 124) differs from the central axis 1a by 90 degrees.
  • a first connecting portion 106 is provided between the head 150 and the first compression unit 110.
  • the first connecting portion 106 has a forward tapered shape that is a tapered surface (forward tapered surface) that increases as the inner surface and outer surface thereof move away from the head 150.
  • the second connecting portion 107 has a cylindrical shape whose inner surface and outer surface are both cylindrical surfaces.
  • first connecting portion 106 and the second connecting portion 107 is not limited to the above, and may be any shape. Further, one or both of the first connecting part 106 and the second connecting part 107 may be omitted.
  • the head 150 is formed with a lumen 151 that communicates with the internal space of the outer peripheral wall 101.
  • a portion including the tip 10 t of the bottle needle 10, the opening of the gas flow path 12, and the opening of the lateral hole 11 a is inserted into the lumen 151.
  • the shape of the inner peripheral surface of the lumen 151 is arbitrary, but can be set to a shape along the outer peripheral surface of the bottle needle 10.
  • the inner diameter of the lumen 151 is preferably set slightly smaller than the outer diameter of the bottle needle 10 so that the inner peripheral surface of the lumen 151 is in close contact with the outer peripheral surface of the bottle needle 10. Since the horizontal hole 11a extends in a direction perpendicular to the central axis 1a, the opening of the horizontal hole 11a is sealed in a liquid-tight manner by the inner peripheral surface of the lumen 151.
  • a slit 153 that penetrates the head 151 in the vertical direction is formed in the deepest portion 152 of the lumen 151.
  • the slit 153 is a linear notch whose shape viewed from above is a “ ⁇ ” (minus) shape.
  • ⁇ minus
  • the upper surface 155 of the head 150 is formed with a convex portion 156 that protrudes upward from the upper surface 155.
  • the outer surface of the convex portion 156 is a substantially conical surface, but the present invention is not limited to this, and may be a convex curved surface that swells smoothly in a dome shape, such as a substantially truncated cone surface or a spherical surface. Good.
  • the slit 153 passes through the top (center) of the convex portion 156.
  • the base 180 is provided to fix the cover 100 to the base material 19 (see FIG. 1).
  • the method for fixing the base 180 to the substrate 19 is not particularly limited, and any method such as adhesion, fusion, engagement, and fitting can be used.
  • the shape of the base 180 can be arbitrarily set according to the fixing method. In order to accurately position the cover 100 with respect to the bottle needle 10, at least one of the base portion 180 and the base material 19 may be formed with a fitting shape that fits the other.
  • the bottle needle 1 with a cover according to the first embodiment is punctured into a rubber stopper of a vial bottle.
  • the present inventors photographed a sectional view of the deformation of the cover 100 and the rubber stopper before and after the bottle needle 1 with a cover was inserted into the rubber stopper of the vial using X-ray CT. Observed. This will be described below.
  • FIGS. 8A and 8B are cross-sectional views created based on photographs taken by X-ray CT of the state before the bottle needle 1 with cover according to Embodiment 1 of the present invention is punctured into the rubber stopper 925 of the vial 920.
  • FIG. is there.
  • the cross sections of FIGS. 8A and 8B are the same as the cross sections of FIGS. 6A and 6B, respectively.
  • the rubber stopper 925 is attached to the mouth 921 of the vial 920, whereby the vial 920 is sealed.
  • a cap 926 is attached to the port 921 and the rubber plug 925 so that the rubber plug 925 does not come off from the port 921.
  • An opening 927 is formed at the center of the cap 926, and the rubber plug 925 is exposed in the opening 927.
  • the bottle needle 1 with cover and the rubber stopper 925 are opposed to each other.
  • the convex portion 156 of the head 150 of the cover 100 is pressed against the rubber stopper 925 exposed in the opening 927 of the cap 926, and the bottle needle 10 is pushed toward the vial 920.
  • the tip 10t of the bottle needle 10 penetrates the slit 153 of the head 150, and further punctures the rubber stopper 925 and penetrates it.
  • the cover 100 is elastically compressed and deformed in the direction of the central axis 1a.
  • 9A and 9B are cross-sectional views created based on photographs taken by X-ray CT of the state in which the bottle needle 1 with cover of the first embodiment is punctured into the rubber stopper of the vial bottle.
  • 9A and 9B are the same as the cross sections of FIGS. 8A and 8B, respectively.
  • the bottle needle 10 penetrates the slit 153 formed in the head 150 of the cover 100, and further penetrates the rubber stopper 925.
  • the portion around the bottle needle 10 of the rubber stopper 925 is greatly deformed into the vial 920 by being penetrated by the bottle needle 10.
  • the lateral hole 11a opened to the tip 10t side of the bottle needle 10 and the gas flow path 12 are exposed in the vial 920.
  • the liquid can be allowed to flow into the vial 920 through the liquid channel 11 and the lateral hole 11a, and the liquid in the vial 920 can be allowed to flow out of the vial 920.
  • air pressure in the vial bottle 920 is reduced, and entrance / exit of a liquid is made easy.
  • the cover 100 receives a compressive force from the rubber plug 925, and the convex portion 156 (see FIGS. 6A and 6B) of the head 150 is deformed so much that the initial shape is not recognized and is closely attached to the rubber plug 925.
  • the outer peripheral wall 101 is greatly compressed and deformed.
  • the deformed shape of the outer peripheral wall 101 is substantially symmetric with respect to the central axis 1a. This indicates that the outer peripheral wall 101 is not substantially buckled.
  • the deformation of the outer peripheral wall 101 is not constant in the circumferential direction. That is, as shown in FIG. 9A, the first compression unit 110 is greatly bent and deformed so that the outer surface 111a and the outer surface 112a are in contact with each other in the cross section including the pair of concave portions 114 (thin wall portions). On the other hand, as shown in FIG. 9B, the cross section including the pair of convex portions 113 (thick portions) is slightly bent so as to bulge outward. Further, as shown in FIG.
  • the second compression unit 120 is greatly bent and deformed so that the outer surface 121a and the outer surface 122a are in contact with each other in the cross section including the pair of concave portions 124 (thin wall portions).
  • the cross section including the pair of convex portions 123 (thick portions) is slightly bent so as to bulge outward.
  • the first compression unit 110 and the second compression unit 120 are hardly deformed in a portion having relatively high mechanical strength (rigidity) due to the formation of the thick portion (the convex portions 113 and 123).
  • the thin-walled portions are bent and deformed greatly at portions having relatively low mechanical strength (rigidity).
  • the first cross section shown in FIG. 9B the second compression unit 120 is mainly deformed with almost no deformation, and the second compression unit 120 is mainly deformed.
  • the outer peripheral wall 101 can be greatly compressed and deformed in the direction of the central axis 1a without being buckled.
  • first compression unit 110 and the second compression unit 120 have substantially similar shapes, a portion (a portion having a relatively low mechanical strength) and a small portion (a portion having a relatively low mechanical strength) in the direction of the central axis 1a.
  • the first compression unit 110 and the second compression unit 120 have a modification in which the portions having relatively high mechanical strength are alternately formed in the circumferential direction. Since the first compression unit 110 and the second compression unit 120 are stacked one above the other with a phase shift, it is possible to increase the amount of dimensional change due to compression of the entire cover 100 while suppressing buckling deformation. it can.
  • the second compression unit 120 has a larger diameter than the first compression unit 110, the outer peripheral wall 101 can be deformed so that the first compression unit 110 enters the second compression unit 120. Thereby, the dimensional change amount of the cover 100 can be further increased. Since the dimensional change amount of the cover 100 is large, the height (the dimension in the direction of the central axis 1a) of the cover 100 at the time of compression (FIGS. 9A and 9B) can be reduced. The insertion depth can be increased.
  • the outer peripheral wall 101 of the cover 100 is elastically recovered and extended. That is, the bottle needle 10 moves relative to the rubber plug 925 and the head 150 in a state where the convex portion 156 of the head 150 of the cover 100 is in close contact with the rubber plug 925. In this process, the rubber plug 925 and the edge of the slit 153 of the head 150 slide on the outer peripheral surface of the bottle needle 10, and the liquid adhering to the outer peripheral surface of the bottle needle 10 is peeled off.
  • the rubber stopper 925 When the bottle needle 10 passes through the rubber stopper 925, the rubber stopper 925 is elastically recovered and returns to the initial shape, and the hole of the rubber stopper 925 that has been punctured by the bottle needle 10 is immediately closed. Thereafter, when the bottle needle 10 passes through the slit 153 of the head 150 of the cover 100, the slit 153 immediately recovers and closes.
  • the tip 10t of the bottle needle 10 and the vicinity thereof are accommodated in the lumen 151 of the head 150.
  • the inner peripheral surface of the lumen 151 is in close contact with the outer peripheral surface of the bottle needle 10 and closes each opening on the side hole 11a and the distal end 10t side of the gas flow path 12. Thereafter, the convex portion 156 of the head 150 is separated from the rubber plug 925 and returns to the initial state shown in FIGS. 8A and 8B.
  • the cover 100 is attached to the bottle needle 10. Therefore, in a state where the bottle needle 10 is not punctured by the rubber stopper 925, the liquid can be prevented from leaking from the bottle needle 10 to the outside.
  • the horizontal hole 11a extends along a direction orthogonal to the central axis 1a and opens on the outer peripheral surface of the bottle needle 10. This is advantageous in that the inner peripheral surface of the inner cavity 151 of the cover 100 closes the lateral hole 11a in a liquid-tight manner. Further, when the bottle needle 10 punctured in the rubber stopper 925 is pulled out from the rubber stopper 925, the liquid adhering to the periphery of the opening of the lateral hole 11a is peeled off at the edges of the rubber stopper 925 and the slit 153 of the head 150. Since it becomes easy to remove, it is advantageous in reducing the amount of liquid remaining around the opening of the lateral hole 11a after being pulled out from the rubber plug 925.
  • a convex portion 156 protruding toward the rubber plug 925 is formed on the surface of the head 150 facing the rubber plug 925. Therefore, after the bottle needle 10 punctures the rubber stopper 925, the bottle needle 10 is pulled out from the rubber stopper 925 until the tip 10t of the bottle needle 10 is accommodated in the lumen 151 of the cover 100.
  • the portion near the slit 153 of the portion 150 and the rubber stopper 925 are kept in close contact. This is advantageous in reducing the amount of liquid adhering to the outer surface of the head 150 and the outer surface of the rubber plug 925 after the head 150 and the rubber plug 925 are separated.
  • FIG. 10 is sectional drawing along the surface containing the central axis 1a of the bottle needle 2 with a cover concerning Embodiment 2 of this invention.
  • FIG. 11 is a perspective view of the cover-equipped bottle needle 2 as viewed from above.
  • the same members as those in the first embodiment are denoted by the same reference numerals, and description thereof will be omitted.
  • the outer peripheral wall 201 of the cover 200 has a so-called bellows shape, and this is different from the outer peripheral wall 101 of the cover 100 of the first embodiment. That is, the outer peripheral wall 201 has a bellows shape whose outer diameter and inner diameter are changed in a constant cycle in the direction of the central axis 1a within a certain range. Similar to the outer peripheral wall 101 of the first embodiment, the outer peripheral wall 201 can be elastically compressed and deformed so that the dimension in the direction of the central axis 1a is shortened.
  • the macroscopic outer diameter of the outer peripheral wall 201 is constant in the direction of the central axis 1a.
  • the present invention is not limited to this, and for example, the outer diameter of the outer peripheral wall 201 increases toward either side in the direction of the central axis 1a. May be.
  • the second embodiment is the same as the first embodiment except for the above.
  • the second embodiment also has the same effect as the first embodiment.
  • the horizontal hole 11a of the bottle needle 10 extends along a straight line (that is, the radial direction) orthogonal to the central axis 1a.
  • the central axis 1a May extend along a straight line that intersects at an angle other than a right angle to the straight line, or may extend along a straight line that does not pass through the central axis 1a.
  • the horizontal hole 11a may cross the liquid flow path 11 and penetrate the bottle needle 10 along the horizontal direction.
  • a plurality of lateral holes 11 a may communicate with the liquid flow path 11. In this case, a plurality of openings formed on the outer peripheral surface of the bottle needle 10 in the lateral hole 11a are formed according to the number of the lateral holes 11a.
  • the convex portions 156 are formed on the upper surfaces 155 of the covers 100 and 200, but the shape of the upper surface 155 can be arbitrarily set. For example, the convex portion 156 may be omitted.
  • the head 150 of the covers 100 and 200 and the rubber stopper 925 are kept in close contact until the bottle needle 10 is removed from the rubber stopper 925.
  • the top surface 155 of the head 150 faces the rubber plug 925 because it is advantageous for reducing the amount of liquid remaining on the upper surface 155 of the head 150 and the outer surface of the rubber plug 925 after the rubber plug 925 is removed from the rubber plug 925. It is preferable to protrude.
  • a lock mechanism may be provided so that the bottle needle 10 punctured in the rubber stopper 925 does not come out unintentionally.
  • a lock mechanism is arbitrary, for example, a cylindrical hood provided with a locking mechanism for locking to the mouth 921 of the vial 920 can be integrally provided on the base 19.
  • the compression units 110 and 120 configuring the cover 100 include the first region having the cylindrical shape and the second region having the forward tapered shape, but the configuration of the compression unit is not limited to this. . What is necessary is just to be able to bend and deform so that the part which has relatively low mechanical strength of a compression unit may be folded when compression force is applied. In general, it is advantageous that the compression unit includes two or more regions having different angles of the outer surface or the inner surface with respect to the central axis 1a in order to cause such bending deformation.
  • the outer peripheral wall 101 includes two compression units, but the number of compression units constituting the outer peripheral wall 101 is not limited to two, and may be three or more.
  • the number of the compression units is large, the dimensional change amount of the cover at the time of compression can be easily increased, which is advantageous when the bottle needle 10 is long.
  • the number of compression units constituting the outer peripheral wall is preferably 4 or less, and more preferably 2 or 3.
  • a portion with a large amount of dimensional change in the direction of the central axis 1a during compression portion having a relatively low mechanical strength
  • a portion with a small amount (relatively high) portion with a small amount (relatively high)
  • the thick portion and the thin portion are formed so that the portion having the mechanical strength is opposed to the vertical direction.
  • the diameters (sizes) of the plurality of compression units constituting the outer peripheral wall 101 need not all be different.
  • the diameters of the plurality of compression units constituting the outer peripheral wall 101 may all be the same.
  • the arrangement of the plurality of compression units having different diameters in the order of the diameter in the direction of the central axis 1a has the advantage that the amount of dimensional change during compression can be increased.
  • the arrangement of the plurality of compression units having different diameters so that the diameter of the compression unit farther from the head 150 becomes larger is a mold when a cover is molded using a mold. There are advantages such as easy removal, improved attachment stability of the cover using the base 180, and a reduction in the size of the head 150.
  • both the convex part (thick part) and the concave part (thin part) are formed in the compression unit, but either one may be omitted. Even if any of the convex portion (thick portion) and the concave portion (thin portion) is omitted, the thickness of the compression unit can be periodically changed in the circumferential direction, and the above-described effect of the present invention can be obtained.
  • the convex portion (thick portion) and the concave portion (thin portion) are formed, the convex portion (thick portion) and the concave portion (thin portion) are alternately arranged in the circumferential direction.
  • the convex portion (thick portion) may be formed on the inner surface of the compression unit, and the concave portion (thin portion) may be formed on the outer surface of the compression unit.
  • forming the convex portion on the outer surface of the compression unit and forming the concave portion on the inner surface of the compression unit as in the first embodiment secures a large space between the outer peripheral wall 101 and the bottle needle 10. Is preferable. The larger the space between the outer peripheral wall 101 and the bottle needle 10, the less likely the collision between the outer peripheral wall 101 deformed during compression and the bottle needle 10 will occur, so the dimensional change amount of the entire cover can be increased. is there.
  • the convex part (thick part) and the concave part (thin part) may be formed only on a part of the compression unit in the direction of the central axis 1a. However, forming over the entire range of the compression unit in the direction of the central axis 1a can reduce deformation at a portion where deformation is not desired and increase deformation at a portion where deformation is desired. This is advantageous for preventing buckling deformation of the material and increasing the amount of dimensional change during compression.
  • the number N of convex portions (thick portions) and concave portions (thin portions) formed in the compression unit does not have to be 2 as in the first embodiment, and may be 3 or more. However, as the number N increases, the dimensional change amount of the cover during compression decreases. Therefore, the number N is preferably 4 or less, more preferably 2 or 3.
  • N is an integer of 2 or more convex portions (thick portions) and / or concave portions (thin portions) are formed on each compression unit, the convex portions between the two compression units adjacent to each other in the direction of the central axis 1a.
  • the position of the part (thick part) and / or the concave part (thin part) is shifted in the circumferential direction.
  • the amount of misalignment between the convex portions (thick portions) and / or the concave portions (thin portions) between two compression units adjacent in the direction of the central axis 1a is 360 / 2N degrees with respect to the central axis 1a. Is preferred.
  • the cross-sectional shape along the plane perpendicular to the central axis 1a of the outer peripheral walls 101 and 201 is circular.
  • the cross-sectional shape of the outer peripheral wall is not limited to this, and the positive direction and the regular six It may be a regular polygon such as a square, an arbitrary polygon, or an ellipse.
  • the outer peripheral wall preferably has a circular cross-sectional shape.
  • the field of use of the present invention is not particularly limited, but can be preferably used in the field of bottle needles pierced by rubber stoppers used for vials and the like.
  • it can be preferably used in the field of handling dangerous drugs (for example, anticancer drugs) and blood that need to be prevented from leaking or evaporating.
  • dangerous drugs for example, anticancer drugs
  • blood that need to be prevented from leaking or evaporating.
  • it can also be used in various fields that handle liquids such as foods other than those for medical use.

Landscapes

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

Abstract

Cette aiguille de bouteille (10) a un trajet d'écoulement de liquide formé indépendamment (11) et un trajet d'écoulement de gaz (12), et un trou horizontal (11a) communiquant avec le trajet d'écoulement de liquide est ouvert sur la surface périphérique externe de l'aiguille de bouteille. Un couvercle (100) est pourvu d'une paroi périphérique externe (101) qui a une forme sensiblement cylindrique et peut être élastiquement déformée par compression et d'une tête (150) disposée à une extrémité de la paroi périphérique externe. Lorsque la paroi périphérique externe n'est pas déformée par compression, la tête du couvercle obture le trou horizontal ouvert dans la surface périphérique externe de l'aiguille de bouteille. Lorsque la tête est déplacée par rapport à l'aiguille de bouteille de telle sorte que la paroi périphérique extérieure est déformée par compression, l'aiguille de bouteille perfore la tête, et le trou horizontal et le trajet d'écoulement de gaz sont exposés à partir de la tête.
PCT/JP2013/057216 2012-03-23 2013-03-14 Aiguille de bouteille pourvue d'un couvercle WO2013141137A1 (fr)

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JP2012067283 2012-03-23

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015226749A (ja) * 2014-05-02 2015-12-17 株式会社ジェイ・エム・エス オス部材用カバー及びコネクタ
EP3045200A1 (fr) * 2015-01-16 2016-07-20 Sanofi-Aventis Deutschland GmbH Unité d'aiguille
WO2016124430A1 (fr) * 2015-02-02 2016-08-11 Sanofi-Aventis Deutschland Gmbh Unité d'aiguille pour percer une paroi de réservoir de médicament depuis l'intérieur
CN112439125A (zh) * 2020-12-09 2021-03-05 深圳麦科田生命科学有限公司 无针输液阀体和无针输液接头
WO2022163311A1 (fr) 2021-02-01 2022-08-04 株式会社ジェイ・エム・エス Raccord médical
GB2613150A (en) * 2021-11-23 2023-05-31 Quanta Dialysis Technologies Ltd Infusate bag spike
US11674614B2 (en) 2020-10-09 2023-06-13 Icu Medical, Inc. Fluid transfer device and method of use for same

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Publication number Priority date Publication date Assignee Title
JPS61146269A (ja) * 1984-12-17 1986-07-03 デラタ　コ−ポレ−シヨン 注射液バイアル用アダプターを備えた噴射式皮下注射器
JPH01148272A (ja) * 1987-11-04 1989-06-09 Critikon Inc 腸管外液剤容器のためのスパイク
JPH07505064A (ja) * 1991-12-18 1995-06-08 アイシーユー　メディカル、インコーポレイテッド 医療用弁
WO2012008285A1 (fr) * 2010-07-12 2012-01-19 株式会社ジェイ・エム・エス Dispositif d'administration de solution de médicament destiné à un usage médical

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61146269A (ja) * 1984-12-17 1986-07-03 デラタ　コ−ポレ−シヨン 注射液バイアル用アダプターを備えた噴射式皮下注射器
JPH01148272A (ja) * 1987-11-04 1989-06-09 Critikon Inc 腸管外液剤容器のためのスパイク
JPH07505064A (ja) * 1991-12-18 1995-06-08 アイシーユー　メディカル、インコーポレイテッド 医療用弁
WO2012008285A1 (fr) * 2010-07-12 2012-01-19 株式会社ジェイ・エム・エス Dispositif d'administration de solution de médicament destiné à un usage médical

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015226749A (ja) * 2014-05-02 2015-12-17 株式会社ジェイ・エム・エス オス部材用カバー及びコネクタ
EP3045200A1 (fr) * 2015-01-16 2016-07-20 Sanofi-Aventis Deutschland GmbH Unité d'aiguille
WO2016124430A1 (fr) * 2015-02-02 2016-08-11 Sanofi-Aventis Deutschland Gmbh Unité d'aiguille pour percer une paroi de réservoir de médicament depuis l'intérieur
US11674614B2 (en) 2020-10-09 2023-06-13 Icu Medical, Inc. Fluid transfer device and method of use for same
CN112439125A (zh) * 2020-12-09 2021-03-05 深圳麦科田生命科学有限公司 无针输液阀体和无针输液接头
WO2022163311A1 (fr) 2021-02-01 2022-08-04 株式会社ジェイ・エム・エス Raccord médical
GB2613150A (en) * 2021-11-23 2023-05-31 Quanta Dialysis Technologies Ltd Infusate bag spike

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