WO2015097067A1 - Système d'obturation, en particulier obturateur de seringue et contenant pour préparations pharmaceutiques, en particulier seringue à usage médical - Google Patents

Système d'obturation, en particulier obturateur de seringue et contenant pour préparations pharmaceutiques, en particulier seringue à usage médical Download PDF

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Publication number
WO2015097067A1
WO2015097067A1 PCT/EP2014/078521 EP2014078521W WO2015097067A1 WO 2015097067 A1 WO2015097067 A1 WO 2015097067A1 EP 2014078521 W EP2014078521 W EP 2014078521W WO 2015097067 A1 WO2015097067 A1 WO 2015097067A1
Authority
WO
WIPO (PCT)
Prior art keywords
cap
longitudinal axis
cap member
closure system
connection
Prior art date
Application number
PCT/EP2014/078521
Other languages
German (de)
English (en)
Inventor
Mustafa Kuecuek
Christoph Huber
Levent Kusogullari
Bastian Fischer
Katharina JENOEFI
Qazim FETOSHI
Edwin SCHELLENBERG
Heinz HAEBERLIN
Thomas Faessler
Original Assignee
Schott 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
Application filed by Schott Ag filed Critical Schott Ag
Publication of WO2015097067A1 publication Critical patent/WO2015097067A1/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
    • A61M5/50—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
    • 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
    • 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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw

Definitions

  • Closure system in particular syringe closure and container for pharmaceutical preparations, in particular syringe for medical purposes
  • the invention relates to a closure system, in particular syringe closure, for sealingly sealing a distal opening of a container for pharmaceutical preparations, the closure system having a container arranged around the distal opening or can be arranged
  • the invention further relates to a container for pharmaceutical preparations, in particular a syringe for medical purposes with such a closure system.
  • US 6,190,364 shows a closure system for a container, in particular syringe body.
  • the syringe body itself has a distal tip and a distal opening extending therethrough,
  • the syringe body comprises a syringe body arranged or arranged
  • This attachment region can be formed integrally with the syringe or placed on the distal tip of the syringe body and firmly connected thereto.
  • the attachment area further has
  • Threaded or bayonet structures which cooperate with threaded elements of a two-part cap to hold the cap on the mounting area.
  • the cap encloses the region of the distal tip or tip cone and closes and seals the distal opening of the syringe body.
  • the cap is screwed from the mounting area in US 6,190,364 and an injection cannula is attached to the sphincter body so that a needle opening extending through the injection cannula is in conductive communication with the distal opening of the syringe body.
  • a problem with such closure systems is that it should be ensured that they can not be used again in certain applications, for example with another drug or for others
  • 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 on the syringe opening are recognized, and on the other hand, production has been considerably simplified compared to US Pat. No. 6,190,364.
  • 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 latching means of both the Fastener as well as the cap designed in such a way that they are not unlocked without damage, that is, after unlocking no damage-free reclosing is possible.
  • EP 1 600 190 A1 Although a damage-free reclosing is excluded in EP 1 600 190 A1, it is still 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.
  • sealing areas of the cap forming elastomeric closures (tip caps) for plastic and glass syringes can be brought back to its original state after intentional or accidental opening all. Since these closures have no tamper evidence or indicators, the visual recognition of the first use is not given. There is a risk that these
  • the contaminated contents of the syringe are administered to a patient, it can lead to infections, thereby jeopardizing the health of the patient.
  • the original contents of a syringe can be changed after opening the tip cap and the syringe can be closed again unnoticed. Patients may be given an incorrect dose of medication or the contents of a syringe may be administered to multiple patients. This can cause serious health problems. Tip caps may also be applied after opening to another syringe with another drug. This can be traces of a
  • a syringe can be wound up after opening the tip-cap 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.
  • the object of the invention is therefore to avoid the disadvantages of the prior art and to provide a closure system for sealing in particular a syringe opening, the one-time use of the cap guaranteed easy and safe and excludes a resealing safely. Furthermore, an orgin Chesver gleich the user on the initial use preferably visually point out, especially to prevent repeated use or misuse. Furthermore, these functions with minimal number of components and low production costs for
  • a closure system for sealing a distal opening of a container for pharmaceutical sealing
  • the closure system comprises a fastening region arranged or arrangeable on the container around the distal opening and a sealing cap releasably sealing the distal opening and detachably connected to the attachment region and forming a sealing region for the distal opening with at least two relatively movable ones
  • Cap elements comprises and is designed to extend along a theoretical longitudinal axis, according to the invention is characterized in that a first, the sealing region exhibiting or this receiving
  • Cap member in the circumferential direction around the longitudinal axis considered in a direction which is also referred to as loosening force is positively and / or positively connected to the mounting portion, and that the second cap member relative to the first cap member in the direction of the longitudinal axis of a first functional position, which also as Closure position is irreversibly in at least a second functional position, which is also referred to as release position is movable, the second cap member in the first functional position via a first, in the direction of the longitudinal axis and effective in the circumferential direction about the longitudinal axis of a movement permitting force and / or positive connection with the first cap member is connected, and the second cap member in the second functional position in Viewed circumferential direction about the longitudinal axis in only one direction, the main direction component of the direction for releasing the non-positive and / or positive connection between the first cap member and
  • Fastening corresponds to rotation with the first cap member is connectable.
  • the longitudinal axis describes the orientation of the closure system and the individual parts of these in the longitudinal direction. This coincides with an advantageous cylindrical design and coaxial arrangement of the individual components with the center axis.
  • Sealing includes pressure and / or media-tight. Suitable media include: liquids, gases, solids or mixtures of these. Under pressure-tight in this application, for example, a tight closure of the distal
  • This minimum force ranges from 1 N to 50 N and is dependent on the
  • the solution according to the invention offers the advantage of a two-stage actuation, the movement from the first to the second functional position being irreversible, ie not reversible. This is a certain minimum actuation force required, which is definable as a function of the design of the connecting elements.
  • the distal opening In the second functional position, the distal opening is still closed at first. A release of the distal opening is possible only by complete disassembly of the closure system from the container. This is due to the possible in the second functional position realization of one-sided rotation
  • Attachment area Removing the closure cap as a unit with the sealing area of the distal opening. Due to the one-sided effective non-rotatable connection is a re-attaching the cap on
  • the solution according to the invention thus offers the advantage of providing a relatively simple design and a small number of components, a reuse safe
  • First use can be reliably detected and avoided. Furthermore, the closure system is difficult to operate due to the required minimum actuating force between the first and second functional position and the multi-stage operation for children.
  • At least one of the cap elements is a
  • Associated display device for detecting the second functional position, which is activated when transferring from the first to the second functional position or when reaching this second functional position.
  • the display device comprises for this purpose at least one display element and an actuating device for activating the display element, wherein the display element and the
  • Actuator are arranged on different cap elements.
  • Cap element is at least partially moved out of its present in the first functional position position. This provides an original closure that only exists prior to first use.
  • Constructive implementation is a plurality of possibilities.
  • a particularly advantageous embodiment provides that the second cap member one, a cavity in the circumferential direction around the longitudinal axis enclosing wall and a via a hinge connection and under irreversible
  • Destruction of detachable connecting elements connected to the wall and the cavity on one side at least partially closing lid member comprises.
  • the actuator is from a on a cap member
  • Cap element positively coupled.
  • the second cap element via a second, in
  • Partial actuations of the closure system can thus be reliably detected by the recognizability of this first actuation stage.
  • the first and / or second in the direction of the longitudinal axis and effective in the circumferential direction around the
  • first connecting element formed as an element from the following group: longitudinal axis relative movement between the first and second cap member permitting non-positive and / or positive connection
  • the first connecting elements are complementary thereto formed second connecting elements on the other cap element in
  • Connecting elements are preferably designed as an element from the following group:
  • Circumferential direction extending about the longitudinal axis and at least over a partial region of the inner and / or outer circumferential surface in the circumferential direction extending undercut or recess
  • At least one or a plurality of connecting elements of one of the first and / or second effective in the direction of the longitudinal axis and in the circumferential direction about the longitudinal axis a relative movement between the first and second
  • Cap member permitting non-positive and / or positive connections on one of the two cap elements of the same connecting elements to form.
  • the connecting elements of the first and / or second non-positive and / or positive-locking connections to the other of the two cap elements, which can be brought into operative connection with these, are then arranged at a distance from one another viewed in the direction of the longitudinal axis.
  • Training takes on a cap member only one connecting element, the task of the connecting elements of the first and second, effective in the direction of the longitudinal axis and in the circumferential direction about the longitudinal axis
  • the rotationally fixed connection effective in the second functional position in only one direction in the circumferential direction about the longitudinal axis can be embodied as one of the following connections or a combination thereof:
  • Circumferential direction of the longitudinal axis achieved only in the release direction of the cap. It is not possible to transmit a torque which can be introduced via the second cap element in the opposite direction to this connection.
  • Relative movement in the other direction are free of an operative connection for torque transmission, whereby a re-attaching the cap after a successful release is excluded.
  • connection formed between the first cap member and the attachment portion is made as one of the following compounds or a combination thereof:
  • a screw connection is selected for simplified production and handling as a connection.
  • At least one entrainment connection for the latter is provided on the attachment area Interaction with a mounting tool when creating the connection between the first cap member and mounting area provided.
  • the second cap element is embodied and designed to cover the driver connection on the first cap element in the first and second functional position.
  • MitschanBankes on the first cap member is a plurality of possibilities.
  • Mitschan gleich arranged in a plane with the connecting elements for unilaterally effective rotationally fixed connection in the circumferential direction about the longitudinal axis.
  • the second cap member is not unnecessarily prolonged and interpreted in terms of the longitudinal extent only taking into account the arrangement of the individual compounds.
  • the sealing region for the distal opening may, according to a first embodiment, be integrally formed on the first cap element or according to a second embodiment of a separate, which can be applied to the distal opening
  • Closing element are formed, wherein the closure element is positively and / or non-positively connected to the first cap member. Due to the fact that the sealing area only rests on the opening, there is no possibility of holding on the distal opening after the connection between the closure cap and the fastening area has been released due to the connection with the closure cap.
  • the closure element is designed in training as a separate component, in particular tip-cap with a, a cylindrical or frusto-conical interior enclosing wall extending in the circumferential direction around the
  • the first cap member is designed as an inner cap, comprising a first cap portion for
  • connection area Forming the connection area with the attachment area and the closure element and a second cap portion portion forming the connection areas with the second cap member and optionally of
  • the first cap portion forms a wall enclosing an inner space for supporting the sealing area or the separate closing element in the direction of the longitudinal axis and in the circumferential direction about the longitudinal axis.
  • the second cap portion of the first cap member forms one, the connecting elements of the first and / or second, in the direction of the longitudinal axis and effective in the circumferential direction about the longitudinal axis a movement permitting non-positive and / or positive
  • Circumferential direction around the longitudinal axis effective rotationally fixed connection having or supporting area, which in a sectional plane which is described by two perpendicular to the longitudinal axis by a
  • Basic cross-sectional shape selected from the group of the following cross-sectional shapes is describable:
  • the second cap member is formed as an outer cap, comprising a, a partial region of the first cap member receiving and complementary thereto formed interior.
  • the design of the second cap member is such that it in the second functional position at least the second Cap portion of the first cap member in the direction of the longitudinal axis over a portion of its extension, preferably together with the
  • Attachment area completely enclosing the first cap element.
  • the connecting elements for unilaterally effective rotationally fixed connection on the second cap portion in the direction of the longitudinal axis between the connecting elements in the direction of
  • the connecting elements for unilaterally effective rotationally fixed connection on the second cap portion in the direction of the longitudinal axis constructive in the direction away from the second cap portion portion end portion and the connecting elements of the longitudinal axis in the direction of the longitudinal axis and in the circumferential direction about the longitudinal axis
  • the container can be made of different materials.
  • the container is made of glass or plastic.
  • the attachment region can be formed integrally on the container.
  • the mounting area is already formed during manufacture.
  • the attachment area is formed by a separate, fixed to the container holding part.
  • Syringe body with a closure system according to one of claims 1 to 26 carried out for sealing sealing of the distal opening.
  • the closure system will meet the requirements of the
  • FIG. 1 a shows a first variant of a first embodiment of a closure
  • FIG. 1b shows a first variant of a first embodiment of a closure
  • FIG. 1 c shows a first variant of a first embodiment of a closure
  • FIG. 1 d shows a first variant of a first embodiment of a closure
  • Figure 2a shows a second variant of a first embodiment of a
  • 2d shows a second variant of a first embodiment of a
  • Figure 3a shows a closure system according to the first embodiment of the invention in an exploded view
  • FIG. 3b shows the closure system according to FIG. 1a in the assembled position
  • FIG. 4 a shows a second cap element of the closure cap in three views;
  • Figure 4b in the second cap member of the cap of Figure 4a in a sectional view;
  • FIG. 5a shows a first cap element in three views
  • FIG. 5b in a first cap element of the closure cap according to FIG. 5a in a sectional view
  • FIG. 6a shows a closure element, in particular tip-cap in three views
  • Figure 6b in closure element according to Figure 6a in a sectional view
  • Figure 7a shows a first variant of a second embodiment of a
  • Locking system in assembly position in a view and a
  • Figure 7b shows a first variant of a second embodiment of a
  • Locking system in a first functional position in one
  • Figure 7c shows a first variant of a second embodiment of a
  • FIG. 7 d shows a first variant of a second embodiment of a
  • FIG. 8 is an exploded view of a closure system according to the second embodiment of the invention.
  • FIG. 9a shows a first cap element in three views
  • FIG. 9b in a first cap element of the closure cap according to FIG. 9a in a sectional representation
  • Figure 1 1 a a second variant of a second embodiment of a
  • Figure 1 1 b shows a second variant of a second embodiment of a
  • FIGS. 1 a to 2d illustrate the basic structure
  • Figures 1 a and 2a show a first variant and a second variant of the first embodiment, the closure system 1 in each case in a first
  • FIG. 1 b shows the closure system 1 according to Figure 1 a
  • Figure 2b shows the closure system 1 according to Figure 2a in a sectional view in a plane, which is characterized by the longitudinal axis L and a perpendicular to this.
  • FIGS. 1 c and 2 c show the closure system 1 according to FIGS. 1 a, 1 b and 2 a, 2 b in a second functional position (release position).
  • FIG. 1 d is a sectional view of FIG. 1 c
  • FIG. 2 d is a sectional view of FIG. 2 c.
  • the closure system 1 comprises one on the container 3 around the distal
  • Opening 2 arranged around or can be arranged attachment area 4 and the distal opening 2 sealingly occlusive and with the
  • Attachment area 4 releasably connected closure cap 5.
  • the container 3 is cylindrical and describes one to a
  • the container 3 serves to receive and store one or more
  • the fastening region 4 is formed according to a first variant shown in FIGS. 1a to 1d by a fastening element formed integrally on the container 3, in particular a luer lock 4.1 or luer collar. According to a second variant shown in FIGS. 2a to 2d, the fastening region 4 is formed by a separate fastening element in the form of a Luer lock adapter 4.2.
  • a sealing region 8 formed on or received by the closure cap 5 is provided.
  • closure system 1 for both variants except the
  • Fixing area 4 is the same, the following explanations refer to both variants.
  • the figures 1 a to 2d is a particularly advantageous embodiment of the
  • Shutter system 1 reproduced, in which the individual components are designed such that these in the two functional positions a
  • the closure cap 5 is formed at least in two parts, comprising at least two cap elements movable relative to one another - a first cap element 6 and a second cap element 7.
  • the first cap element 6 accommodates the sealing region 8.
  • the sealing region 8 is here formed in a particularly advantageous manner by a separate closure element 9 in the form of a so-called tip-cap.
  • the closure element 9 is fixed at least indirectly, in this case via the first cap element 6 with respect to the container 3, in particular the attachment region 4 formed on it.
  • Closure element 9 to the attachment portion 4 is effected indirectly by a connection 10 of the closure element 9 with the first cap member 6 and a connection 1 1 of the cap member 6 with the attachment portion 4.
  • the connection 10 of the closure element 9 with the first cap member 6 is in the illustrated case as a positive Connection performed.
  • the connection 1 1 between the first cap member 6 and the mounting portion 4 is designed as a positive connection in the form of a screw connection.
  • the closure element 9 is surrounded by the first cap element 6 in the circumferential direction and over a partial region of its extension in the installation position in the direction of the longitudinal axis L and due to the tightening torque of the screw connection against the distal opening pressed in a sealing manner.
  • the second cap element 7 is non-positively and / or positively locking to the first cap element 6, in the illustrated case via a form-locking connection acting in the direction of the longitudinal axis L. 12 connected.
  • the compound 12 is designed and arranged so that these under Normal conditions, ie a relative movement of the two cap elements 6, 7 prevented in the direction of the longitudinal axis L without additional force or prevents only a very small clearance ⁇ 1 mm and a
  • FIGS. 1 c and 1 d and 2 c and 2 d The second functional position shown in FIGS. 1 c and 1 d and 2 c and 2 d is characterized by the activation of the display device 15.
  • This comprises a display element 16, which is preferably formed by a changeable in its position wall portion on the second cap member 7, in particular a cover part of the second cap member 7. This can be activated via an actuating element 17 provided on the first cap element 6.
  • the second cap member 7 in the direction of the longitudinal axis L to the distal opening relative to the first cap member 6 by applying a
  • the second cap member 7 is connected to the first cap member 6 in the longitudinal direction via a, at least one unidirectional in the direction of the distal opening 2 away effective force and / or positive connection forming compound 13, which, however, a twisting movement of the second cap member second opposite the first cap member 6 in FIG
  • the applied minimum force must therefore be dimensioned such that a dissolution of the connection 12 is achieved and generating the connection 13 is possible.
  • the compound 13 is designed and configured such that a return movement of the second
  • Cap element 7 in the first functional position is no longer possible. This can be achieved by the special configuration and / or dimensioning of the cap elements 6, 7 to be brought into operative connection with one another
  • Circumferentially effective connection 14 between the first and the second cap member 6, 7 executed as only in the release direction of the connection 10 effective non-positive and / or positive connection 14.
  • This unidirectional connection 14 is therefore one-sided in the circumferential direction around the
  • connection 14 is formed, for example, by a unidirectional coupling, this would be in the tightening direction of
  • the cap member 7 is formed and the realization of the
  • Connections 13 and 14 required connecting elements arranged such that in the second functional position, the cap member 7 viewed in the circumferential direction and in the direction of the longitudinal axis L, the first cap member 6 encloses such that the first cap member 6 completely absorbed by the mounting portion 4 and the cap member 7, ie enclosed will and not is more accessible.
  • the second cap element 7 preferably ends flush with the end region directed away from the container 2 in the longitudinal direction. It is also conceivable that the second cap member 7 in the second
  • Functional position encloses a portion of the extension of the mounting portion 4 in the direction of the longitudinal axis L.
  • Figures 2a to 2d show a closure system 1 according to the invention according to the first embodiment in a second variant with formation of the
  • FIG. 3 a shows the closure cap 5 in FIG.
  • Cap 5 reproduced in a mounting position for closing the container 2 as an independently tradable unit.
  • the first cap part 6 is designed as an inner cap, the structure of which is shown in three views in FIG. 5a and in a sectional view in a sectional plane which is characterized by the longitudinal axis L and a perpendicular to it, in FIG. 5b.
  • the first cap member 6 comprises at least two
  • Each of the cap portions 20.1, 20.2 are assigned certain functions.
  • the first cap part area 20.1 is used for attachment to the attachment area and the connection of the Abdicht Schemees 8, while the second cap portion 20.2 of the realization of the compounds with the second cap member 7 in the individual
  • Connecting elements 1 1 .1 provided, which are engageable with complementarily designed connecting elements 1 1 .2 on the mounting portion 4, in particular the Luer-Lock 4.1 or the Luer-Lock adapter 4.2 in operative connection.
  • connecting elements 1 1 .1 and 1 1 .2 4 extending threads are preferably provided in the circumferential direction around the outer periphery of the first cap portion 20.1 and inner circumference of the mounting portion. The orientation of the course of the threads depends on the desired directions for the realization and the release of the connection between the cap member 6 and mounting portion 4 and the desired required tightening torque.
  • the threads are formed on the first cap portion 20.1 only of the connecting elements 10.1 on the first cap member 6
  • the recesses are as open-edged
  • Cap section 20.2. The recesses form axial, i. in the direction of the longitudinal axis L and acting in the circumferential direction contact and support surfaces for the closure element 9, in particular those provided on this
  • the closure element 9 is shown in three views in Figure 6a and in a sectional view in Figure 6b.
  • the closure element 9 is in the form of a hollow cylindrical element closed on one side to form the sealing region 8, in particular an elastomer element. This is designed and dimensioned to at least partially enclose the distal opening 2 and to abut the wall 2 bounding the opening 2 with the sealing region 8.
  • the sealing area 8 is to a surface area on
  • the connecting elements 10.2 are on the outer circumference 21 of the closure element 9, in particular the in
  • Connection 10 is preferably completely free of play in the circumferential direction. As a fit between the connecting elements 10.1 and 10.2 a transition fit or interference fit is preferably selected.
  • the closure element 9, in particular the outer circumference 21, is dimensioned in such a way from the hollow cylindrical area on the first cap element 6 in FIG
  • Cap portion 20.1 to be recorded Preferably, the contour of the closure element 9 is selected such that it rests flush on the inner circumference of the cap portion 20.1.
  • Closing element 9 provided on a on the inner circumference of the first cap member 6 in the connection region 25 and in the installed position of the second
  • Cap portion 20.2 sustainable investment or support surface 31st
  • At least the sealing region 8, preferably the entire closure element 9, are designed as an elastomer part, which in particular is an elastomer suitable for
  • Suitable elastomers are thermoplastic elastomers and butyl rubbers.
  • Elastomers are selected so that the entire cap 5 with all standard sterilization methods such as a gamma sterilization, with, for example 20KGy or ETO or steam with, for example, a
  • the first cap member 6 has in the second cap portion 20.2 here in an end region directed away from the attachment area connecting elements 12.1 for the realization of both sides in the direction of the longitudinal axis L effective and a relative movement in the circumferential direction around the longitudinal axis L permitting positive engagement.
  • These connecting elements 12.1 are executed in the illustrated case as in the circumferential direction on the outer circumference of the second cap portion 20.2 circumferential closed web elements. It is also conceivable
  • Recesses or projections come into operative connection.
  • Connecting elements 12.1, 12.2 takes place with at least one
  • Main direction component perpendicular to the longitudinal axis L, preferably perpendicular to this. It is crucial that the first functional position through this
  • Connection 12 and the positional relationship of the two cap elements 6, 7 to each other by the arrangement of the connecting elements 12.1, 12.2 to this and is determined.
  • the second functional position and the positional relationship of the two cap elements 6, 7 to each other are determined by the arrangement of the connecting elements 13.1, 13.2 at this.
  • the complementary connecting elements 13.1 and 13.2 are arranged on the second cap portion 20.2 and the second cap member 7 and formed such that after relative movement of the second
  • Cap portion 20.2 pointing to the first cap portion 20.1 End area arranged. In this functional position is a mobility of the second cap member 7 in the circumferential direction in a direction around the
  • Cap element 6 when attaching to the mounting portion 4 corresponds.
  • a positive and / or positive connection is generated during relative movement, which enables a rotationally fixed connection 14 between first and second cap element 6, 7 in this direction.
  • the individual connecting elements arranged on the first and second cap elements 6, 7 for realizing the connection 14 and which can be brought into operative connection with one another are denoted by 14.1, 14.2. These are preferably part of a coupling acting in one direction about the longitudinal axis L.
  • the arrangement of the connecting elements 14.1 on the first cap member 6 and 14.2 on the second cap member 7 is such that upon reaching the
  • connection 13 Form fit by connection 13 and the plane for the connection 14 is achieved. Only the application of a moment, in particular a force in the release direction of the connection 1 1 about the longitudinal axis L causes the connection 14.
  • the connecting elements 14.1 on the first cap member 6 preferably extend over at least a portion in the circumferential direction of the first cap member 6, preferably a total of one Angular range> 90 °, more preferably> 180 °. As a result, the free travel of the second
  • Cap member 7 relative to the first cap member 6 in the circumferential direction minimized until engagement.
  • the extent range in the circumferential direction is less than 360 °, to a free travel during rotation of the second
  • the connecting elements 14.1 are arranged here on the outer circumference of the first cap member 6 and the
  • the connecting elements 14.1 and 14.2 are preferably as in terms of their extension in the direction of the longitudinal axis L extending alternately
  • the driver terminal 24 is integrated in a particularly advantageous embodiment in the connection plane of the connection 14 in the free travel.
  • the driver terminal 24 is designed as a recess arranged on the cap element 6 between the connecting elements 14.1 and extending in the radial direction to the longitudinal axis, into which a mounting tool, in particular a lever arm for applying a torque in the circumferential direction of the longitudinal axis L can engage.
  • the arrangement can also be made offset to the connection plane described by the connection 14, but preferably an arrangement is selected, the interaction of a Mitschtechnikmaschinees with the Mit predominantlyan gleich 24 in the second functional position in embodiments with incomplete coverage of the first cap member 6 in the longitudinal direction through the second cap member 7 and the attachment portion 4 securely prevented, thus avoiding improper loosening of the closure system 1.
  • the extent of the first cap member 6 in the longitudinal direction preferably corresponds to the sum of the extension lengths of the required
  • Direction of the longitudinal axis L considered preferably corresponds at least to Extension length of the second cap portion 20.2. Preferably, this is dimensioned such that the second cap member 7 in the second
  • Function position is arranged flush or with a small gap to the mounting portion 4.
  • Cap element 7 recessed grips 18 or webs provided.
  • the second cap portion 20.2 further serves to accommodate
  • the second cap portion 20.2 carries the actuator 17, which here comprises a arranged on a projection and the second cap member 7 in the second functional position or at the transition to this effective contact surface 26 includes.
  • the display device 15 comprises a display element 16, which preferably of a changeable in its position wall area on the second
  • Cap member 7 in particular a cover part of the second cap member 7 is formed. This can be activated via an actuating element 17 provided on the first cap element 6.
  • Display device 15 is formed in the embodiment shown in Figure 3a, 3b and 4a and 4b of a hollow cylindrical cap member 7 unilaterally closing lid member which via a hinge connection 27 on the first cap member 6 and thus the distal opening. 2
  • Cap member 7 is fixed in the circumferential direction forming wall portion. These connecting webs are designed and arranged to be destroyed irreversibly under the action of force in the direction of the longitudinal axis and thus a
  • FIG. 4a illustrates the cap element 7 in three views.
  • 4b shows a sectional view.
  • Recognizable in Figure 4b is the connecting element 12.2, which as on the inner circumference of a hollow cylindrical portion of the
  • Cap element 7 at least partially circumferential in the circumferential direction
  • Projection preferably completely circumferential projection, in particular web element is formed. This functions in functional concentration as a connecting element 13.2 for the realization of the second in the direction of
  • the arrangement of the / the connecting elements 12.2, 13.2 takes place in the direction of the longitudinal axis L viewed in such a spaced manner on the inner circumference of the
  • the cap member 7 relative to the cap member 6 is arranged under realization of the connection 12, wherein the actuating device 17, in particular the contact surface 26 is either spaced from the cover member or rests against this.
  • the arrangement of the connecting element 13.2 relative to the connecting elements 14.2 such that in the second functional position with relative movement of the second cap member 7 relative to the first cap member 6 in the circumferential direction about the longitudinal axis L, a cooperation with the closure elements 14.1 on the cap member. 6 is possible. That is, the connecting elements 13.1 and 14.1 on the cap member 6 and 13.2 and 14.2 on the cap member 7 are arranged at the same distance in the direction of the longitudinal axis viewed on the respective cap elements.
  • the cap member 7 has here in his pointing to the cap part 6
  • FIG. 1 Illustrate the figures 1 to 6, a first embodiment of the closure system 1, the figures 7 ff. A second embodiment in two variants.
  • Locking system 1 differs in the arrangement of the connection 14 in the direction of the longitudinal axis L considered, the provision of a further position, here referred to as mounting position and the embodiment of the first
  • FIG. 7 a shows a first variant of a second embodiment of a closure system 1 in the assembled position in a view and a view from FIG
  • FIG. 7b shows a first variant of a second one
  • Embodiment of a closure system in a first functional position in a view and a sectional view and Figure 7c shows a first variant of a second embodiment of a closure system 1 according to Figure 7b on a container 3 in the first functional position.
  • FIG. 7d shows a first variant of a second embodiment of a closure system 1 on a container in the second functional position
  • FIG. 8 shows an exploded view of a closure system 1 according to the second embodiment of the invention.
  • the basic structure and the basic function are analogous to the embodiments described in FIGS. 1 to 6.
  • the same reference numerals are used for the same elements and therefore reference is made only to the differences.
  • These consist essentially in the formation of the first cap member 6, the additional integration of another functional position and the arrangement of the individual compounds and consequently the connecting elements to the individual cap elements 6, 7 and the functional concentration in the Fasteners. Again, the first cap member 6 with the
  • Cap portion 20.2 and the cap member 7 are carried out analogously as described in Figures 1 to 6.
  • FIG. 9a shows a first cap element 6 in three views and FIG. 9b shows the first cap element 6 of the cap 5 according to FIG. 9a in a sectional view.
  • the connecting elements 12.1, 13.1 of the first and second in the direction of the longitudinal axis L effective and in the circumferential direction around the
  • Connections 12 and 13 on the first cap member 6 are in
  • driver terminal 24 which in the longitudinal direction between the connecting elements 12.1, 13.1 and the first
  • Cap portion 20.1 is arranged on the outer circumference of the first cap member 6.
  • the connecting elements 14.1 for the rotationally fixed connection are in the longitudinal direction of the cap portion 20.1 directed away end of the
  • Cap member 7 in the end portion directed away from the cap member 6, arranged in the installed position the upper, the lid member contained end portion.
  • the connecting elements 12.2, 13.2 of the connections 12, 13 are in
  • Inner circumference of the inner space 33 enclosing wall of the second cap member 7 is arranged and formed here as projecting into the wall recesses, depending on the training of
  • first cap member 6 web segments in the circumferential direction around the longitudinal axis executed recesses as connecting elements 12.2, 13.2 on the cap member 7, which are arranged spaced apart in the direction of the longitudinal axis L defining the individual functional positions to each other.
  • a further recess 34 is provided, which is arranged in pointing to the cap member 6 and in installation position to the container 2 pointing end portion and another functional position, which is the first functional position upstream, by a longitudinally effective connection with the connecting elements 12.1, 13.1 on first cap member 6 allows.
  • the connecting elements 34, 12.2 and 13.2 thus act
  • Abutment surface 26 of the actuator 17 is arranged and the
  • the cap member 7 is spent after attachment of the cap member 6 on the mounting portion 4 by moving in the direction of the longitudinal axis L to the container 2 from the mounting position to the first functional position.
  • the recess 34 is released and the connecting elements 12.2 in the form of the recess are brought into operative connection with the web segments on the first cap element 6.
  • Cap member 7 preferably the driver terminal 24 viewed in the direction of the longitudinal axis L, so that engagement in these is no longer possible.
  • the second cap element 7 is brought into the second functional position, shown in FIG. 7d. In this will be the
  • connection 13 is generated by the engagement of the connecting elements 13.1 in the recess 13.2 on the second cap member 7.
  • the display device 15 is triggered, in particular the cover element unfolded by the action of the contact surface 26 at this.
  • the cap member 7 is rotated in the release direction of the connection 1 1 in the circumferential direction, the rotationally fixed connection 14 is generated in this direction by the connecting elements 14.1, 14.2 are brought into engagement.
  • Figures 7a to 7d show a second embodiment in which the attachment to an integrally arranged on the container 2 mounting region 4 takes place.
  • Figure 11a shows a second variant with separate
  • Attachment area 4 in the form of a Luer lock adapter 4.2 for a second embodiment of a closure system 1 on a container in the first functional position and in a sectional view.
  • FIG. 11b shows the second one Variant of the second embodiment of a closure Systenns 1 on a container in the second functional position and in sectional view.
  • All embodiments have a through the actuating element 17 of the display device extending vent hole 35.

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)
  • Closures For Containers (AREA)

Abstract

L'invention concerne un système d'obturation, en particulier un obturateur de seringue, servant à l'obturation étanche d'une ouverture distale d'un contenant pour préparations pharmaceutiques. Le système d'obturation comporte une zone de fixation disposée ou pouvant être disposée sur le contenant autour de l'ouverture distale et un bouchon obturateur qui obture l'ouverture distale de manière étanche, qui est relié de manière libérable à la zone de fixation et qui forme une zone d'étanchéité pour l'ouverture distale. Ledit bouchon obturateur est pourvu d'au moins deux éléments de bouchon mobiles l'un par rapport à l'autre. Le système d'obturation est également conçu de manière à s'étendre le long d'un axe longitudinal théorique. L'invention est caractérisée en ce qu'un premier élément de bouchon comportant la zone d'étanchéité ou recevant cette dernière, vu dans la direction circonférentielle autour de l'axe longitudinal, est relié de manière libérable dans une direction de libération à force et/ou par coopération de formes à la zone de fixation, et en ce que le deuxième élément de bouchon peut être déplacé par rapport au premier élément de bouchon, en direction de l'axe longitudinal, d'une première position de fonctionnement dans au moins une deuxième position de fonctionnement, et ce de manière irréversible. Le deuxième élément de bouchon, dans la première position de fonctionnement, est relié au premier élément de bouchon par l'intermédiaire d'une première liaison à force et/ou par coopération de formes agissant en direction de l'axe longitudinal et permettant un déplacement dans la direction circonférentielle autour de l'axe longitudinal, et le deuxième élément de bouchon, dans la deuxième position de fonctionnement, peut être relié solidaire en rotation au premier élément de bouchon, vu dans la direction circonférentielle autour de l'axe longitudinal, dans une seule direction, dont la composante de direction principale correspond à la direction de libération de la liaison à force et/ou par coopération de formes entre le premier élément de bouchon et la zone de fixation.
PCT/EP2014/078521 2013-12-23 2014-12-18 Système d'obturation, en particulier obturateur de seringue et contenant pour préparations pharmaceutiques, en particulier seringue à usage médical WO2015097067A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE201320011561 DE202013011561U1 (de) 2013-12-23 2013-12-23 Verschluss-System, insbesondere Spritzenverschluss und Behälter fürpharmazeutische Präparate, insbesondere Spritze für medizinische Zwecke
DE202013011561.0 2013-12-23

Publications (1)

Publication Number Publication Date
WO2015097067A1 true WO2015097067A1 (fr) 2015-07-02

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018061948A1 (fr) * 2016-09-30 2018-04-05 テルモ株式会社 Capuchon, ensemble seringue, et seringue pre-remplie

Citations (1)

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Publication number Priority date Publication date Assignee Title
WO2013083279A2 (fr) * 2011-12-09 2013-06-13 Schott Schweiz Ag Obturateur, notamment obturateur de seringue pour l'obturation étanche d'une ouverture distale d'un corps de seringue

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Publication number Priority date Publication date Assignee Title
US5624402A (en) 1994-12-12 1997-04-29 Becton, Dickinson And Company Syringe tip cap
DE502005001350D1 (de) 2004-05-29 2007-10-11 Gerresheimer Buende Gmbh Spritzenverschluss und Verfahren zum Herstellen eines Spritzenverschlusses
DE102010061061A1 (de) 2010-12-07 2012-06-14 Alfred Von Schuckmann Spritzenkappe

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013083279A2 (fr) * 2011-12-09 2013-06-13 Schott Schweiz Ag Obturateur, notamment obturateur de seringue pour l'obturation étanche d'une ouverture distale d'un corps de seringue

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018061948A1 (fr) * 2016-09-30 2018-04-05 テルモ株式会社 Capuchon, ensemble seringue, et seringue pre-remplie
JPWO2018061948A1 (ja) * 2016-09-30 2019-07-11 テルモ株式会社 キャップ、シリンジ組立体及びプレフィルドシリンジ
US11273264B2 (en) 2016-09-30 2022-03-15 Terumo Kabushiki Kaisha Cap, syringe assembly, and prefilled syringe

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