EP2928528A1 - Bouchon, en particulier bouchon de seringue servant à obturer de manière étanche un orifice distal d'un corps de seringue - Google Patents

Bouchon, en particulier bouchon de seringue servant à obturer de manière étanche un orifice distal d'un corps de seringue

Info

Publication number
EP2928528A1
EP2928528A1 EP13736478.2A EP13736478A EP2928528A1 EP 2928528 A1 EP2928528 A1 EP 2928528A1 EP 13736478 A EP13736478 A EP 13736478A EP 2928528 A1 EP2928528 A1 EP 2928528A1
Authority
EP
European Patent Office
Prior art keywords
closure
syringe
cap
opening
hard
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.)
Withdrawn
Application number
EP13736478.2A
Other languages
German (de)
English (en)
Inventor
Mustafa Kücük
Christoph Huber
Levent Kusogullari
Bastian Fischer
Katharina JENÖFI
Qazim FETOSHI
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.)
Schott Pharma Schweiz AG
Original Assignee
Schott Schweiz AG
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
Priority claimed from PCT/EP2012/005063 external-priority patent/WO2013083279A2/fr
Application filed by Schott Schweiz AG filed Critical Schott Schweiz AG
Priority to EP13736478.2A priority Critical patent/EP2928528A1/fr
Priority claimed from PCT/EP2013/001688 external-priority patent/WO2014086437A1/fr
Priority to US14/731,995 priority patent/US20160001015A1/en
Publication of EP2928528A1 publication Critical patent/EP2928528A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A61M5/504—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the fluid passageway
    • 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
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/20—Closure caps or plugs for connectors or open ends of tubes
    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
    • 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
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle

Definitions

  • the invention relates to a closure, in particular a syringe closure for the sealing closing of a distal opening or a syringe cone of a syringe body.
  • the invention relates to a
  • Syringe closure with a syringe body about the distal opening in particular the syringe cone arranged around or can be arranged
  • Syringe cone sealingly closing and releasably connected to the fastener cap and the cap itself.
  • US 6,190,364 shows a syringe closure for a syringe body.
  • the syringe body itself has a distal tip and a distal opening extending therethrough, in particular in the form of a syringe cone, so that a liquid located in the syringe body can leave the syringe body through the distal opening or syringe cone.
  • the syringe body comprises a fastening element which is arranged or can be arranged on the syringe body.
  • Fastener may be integrally formed with the syringe or placed on the distal tip of the syringe body and firmly connected thereto.
  • the fastener further comprises threaded elements or
  • the closure cap encloses the region of the distal tip or tip cone and seals and seals the distal opening of the syringe body.
  • the closure cap is screwed out of the attachment element and an injection cannula attached to the syringe body in such a way that a needle opening extending through the injection cannula is in a conductive connection with the distal opening of the syringe body.
  • a syringe seal with a sealing strip which is releasably connected to both the fastener and with the cap, so that the seal strip breaks when the cap from
  • EP 1600190 A1 therefore, a syringe closure for sealing and closing has become known in which, on the one hand, manipulations at the syringe opening are recognized and, on the other hand, production has been substantially simplified compared to US Pat. No. 6,390,364.
  • EP 1 600 190 A1 has provided the fastening element with a latching means which is latched with a latching means of the closure cap.
  • the locking means of both the fastener and the cap are designed such that they can not be unlocked without damage, that is, after unlocking no damage-free reclosing is possible.
  • EP 1 600 190 A1 precludes damage-free re-latching, it is possible, at least at the cost of damage to lock the cap again with the fastener. Protection against repeated use in order to ensure a single use for a syringe is also not available from EP 1 600 190 A1.
  • a closure for a prefillable disposable plastic syringe with a syringe body and a directly connected in the exit end end of his injection needle consisting of an outer rigid plastic needle cap made of hard elastic material, directly on the syringe body, the injection needle enveloping, placed is, and the inside, at least in the area of the needle tip, provided with a sealing material consisting of a soft elastic material is known, wherein the plastic needle cap with the syringe body circumferentially welded directly or glued, to form a predetermined separation point in the
  • US 2001/00350 A has disclosed a closure cap connected to a fastening element for closing a distal opening of a syringe body.
  • the disadvantage of this arrangement was that a
  • EP 1 034 810 A1 shows a syringe for medical purposes, having a needle attachment piece attached to the syringe cylinder and closed by a closure cap, for example a tip cap, until the use of the syringe, which is set up in the form of a Luer cone for attaching a cannula in which the closure cap is enclosed together with the end of the needle attachment piece by a safety cap and the closure cap is held positively and / or non-positively in the safety cap, furthermore with a retaining ring which can be firmly latched in its position pushed onto the needle attachment piece on the needle attachment piece.
  • the connection between the safety cap and a retaining ring can be broken.
  • Unrecognized drug can be repeatedly used or confused.
  • the original contents of a syringe can be changed after opening the tip cap and the syringe can be closed again unnoticed.
  • Tip Caps can be applied to another syringe with another drug as described above after opening. This allows traces of a drug through the tip cap to another syringe transferred and thus contaminate the drug. Due to the contamination caused, the effect of a drug can be changed or destroyed. For the patients this can mean serious health consequences.
  • a syringe can be wound up after opening the Tip Caps with other drugs and closed again unnoticed. This will change the effect of the drug. If the modified drug is given to a patient, it can have serious health consequences. In the closures according to the prior art, wanton
  • a closure in particular a
  • Syringe closure for sealingly sealing a distal opening, in particular a syringe cone of a syringe body is provided, wherein the syringe closure arranged on the syringe body around the distal opening, in particular the syringe cone around or
  • Anordenbares fastener and a distal opening, in particular the syringe cone sealingly occlusive and releasably connected to the fastener cap comprises.
  • the closure cap has at least one hard area and an elastomer part, wherein the elastomer part tightly seals the distal opening by resting in the region of a syringe of the distal opening.
  • Tamper-evident closure can be prevented in that the distal opening or the syringe cone is not completely enclosed by the elastomer part, but only partially or even rests only on the distal opening and the opening unexpectedly closes securely pressure-tight only by the support.
  • Another indication of a repeated use or misuse in an embodiment according to the invention is also due to the absence of a
  • Thread ensured. This prevents a positive connection between the closure and the Luer lock or the Luer lock adapter after the opening or use of the closure.
  • pressure-tight means, for example, a tight closure of the distal opening with a pressure of at least 1 bar or more for at least 30 seconds.
  • closure cap with the
  • Connecting surface (s) connected by a joining method in particular glued and / or welded, in particular laser welded and / or
  • the hard area of the cap is thus material fit with the
  • Connection represents the only bracket on the syringe that passes through the
  • connection point (s) or connection surface (s) can be arranged at different points of the hard area of the closure cap.
  • the closure cap comprises a head part and a foot part, wherein the foot part engages in the fastening element and the head part the
  • Closure represents.
  • the / can
  • Fastening element directed side of the foot part can be arranged.
  • Adapter a separate component, the z. B. on a bead of the glass syringe in a predetermined, d. H. defined height locks.
  • the tightness of the connection of the closure cap and distal opening or the cone of the glass syringe is ensured by the predetermined distance and the engagement of the fastening element or fastening ring or luer lock adapter.
  • the syringe closure according to the invention can be used both for a syringe body of a glass material, but also of a thermoplastic.
  • the fastening element in a syringe body made of glass material is a separate component, preferably a fastening ring, which engages in a bead of the glass material at a predetermined height, whereas in a syringe body of a plastic, here a thermoplastic
  • Fastening element is part of the syringe body.
  • the closure cap comprises an elastomer part with which the distal opening, for example the syringe cone, is closed and a region which consists of a hard component, a so-called hard region.
  • the hard component or the hard area of the closure cap with the elastomeric part form fit, in particular in a the distal opening, for example, the syringe cone sheathing area, is connected.
  • the positive connection of the threaded part or the hard part with the elastomeric part has the advantage that over-rotation of the base part is prevented.
  • Base materials are selected accordingly. This allows a broad
  • the grip region of the closure cap is preferably integrated into the elastomer part of the closure cap.
  • the elastomer part covers only a small part of the syringe cone with the distal opening or even covers only the distal opening. This ensures that the elastomer part alone without the cohesive connection between the hard area of the
  • the elastomeric part has only an axial extent which corresponds at most to the axial length of the head part of the closure cap, preferably even shorter than the axial extent of the head part of the closure cap.
  • All of the materials used for the closure cap ie both the elastomer as well as the hard component or component, are chosen so that they can be used for pharmaceutical use.
  • the materials Preferably, the materials have a USP Class VI classification.
  • they are dyeable in a particular preferred embodiment.
  • the elastomers used are preferably elastomers and butyl rubber which have been approved for pharmaceutical use.
  • the hard component can among other things. all approved thermoplastics are used, but particularly preferred are thermoplastics that survive as many types of sterilization without significant geometry or material changes. Exemplary thermoplastics are polycarbonate, polyetheretherketone, polyetherimide, polyetherblockamide, copolyester.
  • a conventional injection molding method may be preferably used for the hard component, and various methods may be used for the elastomer part, preferably the compression / vulcanization method.
  • the elastomer part can also be produced by transfer injection or injection molding. The two components will be in another
  • the closure cap for closing, in particular the distal opening, in particular of the syringe closure consists of a hard area and an elastomeric part, wherein the connection between the elastomeric part and the hard component or the hard area is preferably positive fit and can be realized in various ways.
  • the closure cap includes the hard component, which is preferably designed in the form of a sleeve, in particular an outer cap, a through opening in the axial direction.
  • the opening may be oval, circular or polygonal, in particular polygonal design.
  • the hard region or the hard component, in particular the sleeve, preferably the outer cap, in the first embodiment, comprises at least one axial section which, distributed over a circumference of the section, comprises at least one
  • the distal portion of the outer geometry of the elastomeric member is designed to be congruent with the through-going opening of the hard component.
  • the distal portion of the elastomeric member includes one or more radially projecting portions
  • the projections or ribs of the elastomeric part are then received by the punctures and / or the grooves of the hard component or the hard area.
  • Design elements are dispensed with for this purpose. By engaging the ribs or projections in the windows, both components are locked together axially and radially.
  • the hard component or the hard area includes an opening, in particular a
  • the opening on the proximal side is annular and the opening in at least one axial
  • the opening in the distal region with a non-circular cross-section or a cross-sectional surface with a non-circular inner contour includes ribs or
  • Projections directed inward, d. H. extend radially from the inner contour into the axial opening of the hard component.
  • the number of ribs or projections preferably corresponds to the polygonal design of the opening.
  • the distal region of the outer geometry of the elastomeric component or the base part is designed so that it is congruent with the continuous stepped opening of the hard component, d. H. a portion of the elastomer component is not circular in cross section formed preferably polygonal. The section with non-circular
  • Outer contour comprises in one embodiment grooves in which engage the ribs or projections of the hard area in the mounted state. By engaging the ribs in the grooves, both components are locked together axially and radially.
  • the elastomeric member is inevitably moved with the hard component in the axial and radial directions and thereby separated from the syringe cone.
  • Component or hard area and elastomer part includes the hard
  • Component an opening, in particular through-stepped opening in the axial direction, wherein the voltage applied to the ends of the hard component in the axial direction of the openings are made larger than an intermediate therebetween Opening, ie the cross section of the intermediate opening in the axial
  • the Direction has a first cross section (Qi) which is always less than the second cross section (Q 2 ) and the third cross section (Q 3 ) of the end portions of the opening in the axial direction.
  • the inner contour of the opening at the ends can be designed circular, oval or polygonal.
  • the inner contour of the opening in the first axial region is not circular or circular, in particular
  • the elastomer component or the elastomer part is designed so that it is congruent with the continuous stepped opening of the hard component or the hard area, at least in the distal region. This type of design provides an axial locking of hard and elastomer component or base part.
  • Closure flap are in an efficient and robust design.
  • the axial and radial connection of the two components can be realized in a simple manner. This, in turn, causes both components
  • FIG. 1a- c first embodiment of a syringe closure
  • Fig. 7a-7c closure cap wherein the syringe is a glass syringe and the
  • Fig. 3a Hard area of a closure cap for a closure
  • Fig. 9b.1 - 9c.3 Fig. 3d.1 - Cap, consisting of elastomer part and hard area 3f for a closure according to Figures 1 a - 2, Fig. 4a - 5c, 7a - 8c.
  • Fig. 10a - 10c second embodiment of a syringe closure with Fig. 13a - 13c connecting points on the foot part of the hard area of Fig. 16a - 16c cap, wherein the syringe is a glass syringe and the fastener is a separate component, with the
  • Closure cap is materially connected
  • FIG. 10d section through the fastening element with connecting points or connecting surfaces
  • Fig. 11a - 11c syringe closure according to the second embodiment with Fig. 14a - 14c connecting points on the foot part of the hard portion of Fig. 17a - 17c cap, wherein the syringe is a plastic syringe and the fastening element, with which the closure cap is materially connected, part of Plastic syringe is.
  • Fig. 12a.1 hard area of a closure cap for a closure
  • Fig. 13a - 14c elastomer part of a closure cap for a closure Fig. 16a - 17c of FIG. 10a to 1 c, 13a to 14c, 16a to 17c;
  • Fig. 12d.1 - cap consisting of elastomer part
  • FIGS. 1a-2c, 4a-5c, 7a-8c A complete syringe closure 1 according to a first embodiment of the invention is shown in FIGS. 1a-2c, 4a-5c, 7a-8c.
  • FIGS. 4a, 4a-4c, 7a-7c show an embodiment of the invention in which the syringe body 2 is a glass syringe and the fastening element 3 is a separate component, a so-called Luer-Lock adapter 3.1.
  • Figs. 2a-2c, Fig. 5a-5c, 8a-8c show an embodiment of the invention, in which the syringe body 2 is a plastic syringe and the fastener 3, the so-called Luer-Lock 3.2 or Luer-lock collar 3.2 part of the syringe body 2.
  • the complete syringe closure 1 comprises a syringe body 2 with a distal opening 4.
  • the distal opening 4 of the syringe body 2 is closed and sealed.
  • the elastomer part 10 encloses the distal opening or the syringe cone only partially or when resting not at all, so that the closure after first use can no longer be fixed to the syringe, as there is no positive possibility for this more on the closure is present.
  • the bearing surface for the elastomer part can then, as shown in particular in FIG.
  • pressure-tight means, for example, a tight closure of the distal opening, for example at a pressure of at least 1 bar or more for at least 30 seconds.
  • Suitable elastomers are thermoplastic elastomers and butyl rubbers. The elastomers are selected so that the entire closure cap 20, comprising a hard portion 30 in which the elastomeric member 10 is incorporated, can be sterilized by any standard sterilization method such as gamma sterilization with, for example, 20KGy or ETO or steam of, for example, 121 ° C ° C and above for at least 20 min. or with
  • Electron beams are sterilized. This allows a wide application of the closure caps 20, in addition to glass syringes on syringes made of thermoplastics.
  • the fastener or the mounting ring 3 and the syringe body 2 of the plastic syringe as shown, a one-piece component.
  • the closure cap 20 as a second component comprises a hard component or component 30.
  • the hard component or hard area 30 is according to the invention with the fastening element 3, i. the Luer-Lock 3.1 and in the case of a
  • Plastic syringe the Luer lock adapter 3.2 materially connected, preferably by different molding technologies.
  • Attachment points or contact surfaces are, for example, at Welding columns, for example, by ultrasound or a lateral
  • Einkoppeln laser radiation can be melted onto the welding surfaces and a material-locking connection between the bottom 42 of the hard area 30 and the top 44 of the fastener to
  • connection surface or the welding column 40.1 is shown in particular detail in FIGS. 1c, 2c, 4c, 5c, 7c and 8c. From each of these figures goes in the first
  • Embodiment of the invention shows that the end face 42 of the hard area by the connection points or connecting surfaces 40.2 material fit with the top 44 of the fastener or luer lock or luer lock adapter in the case of glass syringes material fit by a joining method such. As bonding, ultrasound or laser welding are connected.
  • FIG. 10d the fastening element is shown in greater detail in a top view, representative of the closures illustrated in FIGS. 11a-11c, 14a-14c and 17a-17c.
  • the fastener 3.2 shown in Figure 10d is a Luer-lock adapter as it is used in glass syringes.
  • the luer-lock adapter surrounding the distal opening 4 has, in the illustrated embodiment, an annular sleeve 3000 extending from the
  • annular sleeve 3000 gripper 3002.1, 3002.2, 3002.3, 3002.4, 3002.5, 3002.6, 3002.7, 3002.8 extend radially inward to the distal opening.
  • the grippers 3002.1, 3002.2, 3002.3, 3002.4, 3002.5, 3002.6, 3002.7, 3002.8 engage under tension in an undercut surrounding the distal opening and thus secure by clamping the position of the Luer lock adapter on the distal opening 4 of the glass syringe. While the grippers are under tension, the rügförmige sleeve 3000 is largely stress-free.
  • FIG. 10e shows a section along the section line A-A in FIG. 10d.
  • the grippers 3002.4, 3002.8 which bear against the distal opening 4 of the glass syringe in the region of the undercut 3004 under tension.
  • the sleeve 3000 which includes a thread 3010 for screwing on a needle after breaking open the closure closing the distal opening and a support surface 3012, or bottom 46 which or the
  • connection points 40.1, 40.2 of the hard area of the closure cap not shown, and ensure a material-fit connection of the closure cap with the fastening element.
  • the material-locking connection of closure cap and fastening element is formed in the non-tensioned region of the fastening element, so that unintentional breaking of the material-locking connection under load of the energized areas, for example during and after assembly of the fastener element on the distal opening 4 of the glass syringe safely prevented.
  • connection points 40.1, 40.2 are arranged in regions which have low to no mechanical stresses, in particular during and after the assembly of the Luer-Lock adapter or
  • FIGS. 3a.1 to 3a.3 Figures 3a.1 to 3a.3, Figures 6a.1 to 6a.3 and Figures 9a.1 to 9a.3 show different versions of the hard portion 30 of the cap 20.
  • FIG. 3a. 1 to 3a.3 is the opening in the axial direction 100 which is let into the hard area 30 and into which the elastomer part shown in FIGS. 3b.1 to 3c.3 can be inserted.
  • the connecting points 40.1, 40.2, 40.3, which are arranged on the lower side 42 of the head part, can clearly be seen in FIGS. 3a.1 to 3a.3
  • Fastener 3 can be materially connected by a joining process.
  • the foot part of the hard area 30 comprises recessed grips 102 for engaging the closure cap.
  • the elastomer part is designed symmetrically, which allows a very simple production.
  • the elastomer part comprises a middle part 200 and a respective head part 202, 202.2.
  • the head part 202, 202.2 comprises a recess 204 in which the syringe cone can engage in the closed state of the closure cap.
  • the recess is such that only a small part of the syringe cone is enclosed.
  • the end part 202.3, 202.4 is configured without a depression, so that, as shown in FIG. 2b, the elastomer part only rests on the syringe cone when the syringe body is closed.
  • FIG. 2d shows the support of the symmetrical elastomer part 10 on the edge 9 or the tip of the distal opening 4.
  • Expansion of the elastomeric part 10 with D1 is considerably shorter with respect to the extent of the elastomeric part 1000 in the prior art with DO, so that, as in the prior art, in addition to the axial pressure 1100, a radial pressure 1200 is exerted on the distal opening 4.
  • the elastomeric part in its axial extension D1 is substantially shorter than the entire hard component 30 with extension D2 or in particular as the head part 32 of the hard component with the extension D3.
  • the embodiment according to FIGS. 6a.1 to 6f essentially shows a difference in the embodiment with regard to the shape of the elastomer part, as shown in FIGS. 6b.1-6c.3.
  • the elastomer part 6b.1 - 6c.3 im Essentially designed symmetrically and in its length D1 substantially shorter than the entire hard area 30 with length D2.
  • the elastomer part 10 is carried in the rotational movement of the hard component 30 in that
  • the same components as in the preceding figures are designated by the same reference numerals.
  • the projections 302 are again in the middle part 200 of the elastomeric component.
  • the end surfaces 202.1, 202.2 of the elastomeric component, as in the embodiment according to FIGS. 3b.1 and 3b.2, have depressions 204, whereas the end surfaces according to FIGS. 6c.1 to 6c.2 are flat.
  • FIGS. 9a.1 to 9f differ in the embodiment according to FIGS. 9a.1 to 9f.
  • the hard area has 20 openings 400.
  • Corresponding elastomer part is shown in Fig. 9b.1 to 9c.3 and also has a symmetrical shape and protrusions 402, which engages in the windows of the hard area 400 and protrude beyond it, so that the cap can be easily grasped in the head area.
  • connection points are not arranged on the head portion 32 of the hard area 30, but on the foot portion 34 of the hard area, differ in the
  • connection points 40.4, 40.5, 40.6 which are at the foot portion 34 of the hard area 30 in contrast to the first
  • Embodiment are arranged.
  • FIGS. 15a.1 to 15f corresponds to the arrangement according to FIGS. 6a.1 to 6f except for the arrangement of the connection points 40.4, 40.5, 40.6 in the foot region 34.
  • connection points 40.4, 40.5, 40.6 in the foot region 34.
  • Figures 18a.1 to 18f correspond essentially to the configuration of the closure cap according to the figures 9a.1 to 9f. In that regard, reference is hereby made to the same reference numerals. The only difference with respect to the configuration in FIGS. 9a.1 to 9f in the embodiment according to FIGS. 18a.1 to 18f is the arrangement of the connection points 4.4, 4.5, 4.6 in the foot region 34 of the hard region 30.
  • Syringe cone specified which is characterized by the fact that it can be safely used only once and any possibility of reuse in a simple manner is excluded. This is ensured by the fact that a material-locking connection between the cap and the fastener on the syringe cone is given, which must be broken when using. Due to the design of the elastomeric member, the surprisingly even then a tight completion of the syringe cone available, if only on the syringe cone fitting and not or only partially enclosing, ensures that the shutter after the onset of the material connection and thus the first use no longer the
  • Syringe cone can be attached.
  • the hard area has no thread thus a positive connection is excluded. Furthermore, a simple manufacturability is ensured since the
  • Elastomer part is constructed substantially symmetrical. Another advantage of the symmetrical design is that the elastomeric parts do not have to be aligned in a particular direction. For the elastomeric parts previously complex sorting systems are necessary in the art to align the elastomeric parts in a specific mounting direction. This alignment is complicated and can be avoided by the invention.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un bouchon, en particulier un bouchon de seringue servant à obturer de manière étanche un orifice distal (4), par exemple un cône de seringue, d'un corps de seringue. Le bouchon, en particulier le bouchon de seringue, comprend un élément de fixation (3) qui est ou peut être disposé sur le corps de seringue autour de l'orifice distal, en particulier autour du cône de seringue, en particulier un raccord luer lock ou un adaptateur luer lock (3.1), et un capuchon (20) qui obture de manière étanche l'orifice distal, par exemple le cône de seringue, et qui est relié de manière amovible à l'élément de fixation. L'invention est caractérisé en ce que le capuchon est relié dans la zone de l'élément de fixation par liaison de matière, de préférence exclusivement par liaison de matière, à l'élément de fixation, en particulier au raccord ou à l'adaptateur luer lock, par au moins un point de jonction ou une surface de jonction, et en ce que le capuchon comprend une zone dure (30) et une partie en élastomère (10), la partie en élastomère obturant de manière sûre l'orifice distal, en particulier uniquement en appuyant sur ou en entourant un court segment dans la zone d'une pointe de l'orifice distal.
EP13736478.2A 2012-12-07 2013-06-10 Bouchon, en particulier bouchon de seringue servant à obturer de manière étanche un orifice distal d'un corps de seringue Withdrawn EP2928528A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP13736478.2A EP2928528A1 (fr) 2012-12-07 2013-06-10 Bouchon, en particulier bouchon de seringue servant à obturer de manière étanche un orifice distal d'un corps de seringue
US14/731,995 US20160001015A1 (en) 2012-12-07 2015-06-05 Closure element, in particular a syringe closure element for closing a distal opening of a syringe body in a sealing manner

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PCT/EP2012/005063 WO2013083279A2 (fr) 2011-12-09 2012-12-07 Obturateur, notamment obturateur de seringue pour l'obturation étanche d'une ouverture distale d'un corps de seringue
PCT/EP2013/001688 WO2014086437A1 (fr) 2012-12-07 2013-06-10 Bouchon, en particulier bouchon de seringue servant à obturer de manière étanche un orifice distal d'un corps de seringue
EP13736478.2A EP2928528A1 (fr) 2012-12-07 2013-06-10 Bouchon, en particulier bouchon de seringue servant à obturer de manière étanche un orifice distal d'un corps de seringue

Publications (1)

Publication Number Publication Date
EP2928528A1 true EP2928528A1 (fr) 2015-10-14

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP13736478.2A Withdrawn EP2928528A1 (fr) 2012-12-07 2013-06-10 Bouchon, en particulier bouchon de seringue servant à obturer de manière étanche un orifice distal d'un corps de seringue

Country Status (2)

Country Link
US (1) US20160001015A1 (fr)
EP (1) EP2928528A1 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2774650A1 (fr) * 2013-03-04 2014-09-10 Debiotech S.A. Ensemble connecteur capuchon
EP3269418A1 (fr) * 2016-07-12 2018-01-17 Becton Dickinson France Ensemble de capuchon d'extrémité, système médical d'injection et procédé de production d'un système médical d'injection
JP6899071B2 (ja) * 2016-11-18 2021-07-07 住友ゴム工業株式会社 ノズルキャップおよびそのノズルキャップを使ったプレフィルドシリンジ
CN112292168B (zh) 2018-06-22 2023-11-28 赛诺菲 药物输送装置、用于制造药物输送装置的方法和焊接连接的用途
US11305072B2 (en) 2018-11-28 2022-04-19 Fresenius Kabi Usa, Llc Tamper evident assembly for syringes
JP7454910B2 (ja) * 2019-01-21 2024-03-25 ニプロ株式会社 シリンジ用キャップ組体
US12005238B2 (en) * 2020-10-20 2024-06-11 Fresenius Kabi Usa, Llc Impact resistant and tamper evident system for prefilled syringe

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2014086437A1 *

Also Published As

Publication number Publication date
US20160001015A1 (en) 2016-01-07

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