EP2376341B1 - Closure for a container for pharmaceuticals - Google Patents

Closure for a container for pharmaceuticals Download PDF

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Publication number
EP2376341B1
EP2376341B1 EP09771718.5A EP09771718A EP2376341B1 EP 2376341 B1 EP2376341 B1 EP 2376341B1 EP 09771718 A EP09771718 A EP 09771718A EP 2376341 B1 EP2376341 B1 EP 2376341B1
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EP
European Patent Office
Prior art keywords
closure
seal element
wall
sealing element
retaining element
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.)
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Application number
EP09771718.5A
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German (de)
French (fr)
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EP2376341A1 (en
Inventor
Dirk ZÖLCHER
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.)
West Pharmaceutical Services Deutschland GmbH and Co KG
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West Pharmaceutical Services Deutschland GmbH and Co KG
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Application filed by West Pharmaceutical Services Deutschland GmbH and Co KG filed Critical West Pharmaceutical Services Deutschland GmbH and Co KG
Publication of EP2376341A1 publication Critical patent/EP2376341A1/en
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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D41/00—Caps, e.g. crown caps or crown seals, i.e. members having parts arranged for engagement with the external periphery of a neck or wall defining a pouring opening or discharge aperture; Protective cap-like covers for closure members, e.g. decorative covers of metal foil or paper
    • B65D41/02—Caps or cap-like covers without lines of weakness, tearing strips, tags, or like opening or removal devices
    • B65D41/023—Caps or cap-like covers without lines of weakness, tearing strips, tags, or like opening or removal devices with integral internal sealing means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means

Definitions

  • the invention relates to a closure for a preferably sterile medicament container, which closure for connection to the medicament container is thermally deformable by heating, has a prefabricated closure body which is cup-shaped with a bottom and a wall, and which has at least one puncture opening in the bottom of its cup shape , wherein at this closure body in the region of the bottom of its cup shape, an elastic-soft sealing element is arranged such that the at least one puncture opening is closed by the sealing element and a part of the sealing element in the use position of the closure is accessible from outside, wherein the closure body of the Wall independent holding element has, which protrudes in the position of use of the closure inwardly from the bottom of the cup-shaped closure body, and wherein a receptacle for the sealing element is formed by the holding element and the Dichtele ment is arranged in the recording.
  • closures are previously known according to the preamble of claim 1, which made it be that first a closure body is produced in the form of a cap and in a further manufacturing step in the same tool or a part thereof, the elastic-soft sealing element is injected into the cap.
  • the sealing element is injected into the closure body, whereby a large area connection area between sealing element and closure body is formed, and that the closed by the closure medicine bottle has at its mouth a bottle cap integrally connected to the medicine bottle, to which the sealing element in the unused state sealingly the bottle cap rests and is supported by this at least partially.
  • the production of such an arrangement requires complex tool.
  • a closure of the type mentioned is known, which is thermally deformable for connection to a medicament container by heating and a has prefabricated closure body which is cup-shaped with a bottom and a wall.
  • an elastic-soft sealing element is arranged such that the at least one puncture opening is closed by the sealing element.
  • the sealing element is arranged in a retaining element serving as a receptacle, which protrudes inward in the position of use of the closure from the bottom of the pot-shaped closure body.
  • the cavity formed by the cylindrical holding member may be filled with a preferably rubber-made sealing material.
  • the cylindrical holding element of the WO 2009/0954881 A1 Prior art closure also has the end facing the container interior an outer or bottom wall, which must be pierced by means of a spray cannula, such that after removal of the cannula a puncture hole remains in the outer wall.
  • the present invention has for its object to provide a closure for a particularly sterile medication container, in which the maintenance of the sealing element is improved on the cap.
  • the sealing element is prefabricated, inserted into the receptacle and held therein under prestress, and that the sealing element is materially connected to the closure body.
  • the sealing element is prefabricated, inserted into the receptacle and held therein under prestress.
  • the advantage here is that an inserted in use with a cannula or needle in the sealing element puncture hole can be automatically closed by the bias of the sealing element after use.
  • the sealing element with the closure body is materially connected, for example by injection, gluing or welding.
  • the closure body may consist of non-elastic material, for example a hard plastic.
  • the puncture openings may be closed from outside by removable covers before use.
  • the bottom is flat or flat. But it can also be used a curved outward or inward floor.
  • the medicament container may, for example, be a bottle or a pouch or a general container for preferably liquid medicaments.
  • the medication container is often placed down or suspended, so that the bottom of the cup shape of the closure body is disposed under the wall.
  • a particularly good decoupling of the retaining element from the deformation forces, which are introduced under thermal stress of the closure body in the closure body, is achieved when the holding element is spaced from the wall of the cup shape of the closure body and with this at least in sections, preferably over the entire extension of the holding element on the bottom of the pot shape, forming a gap.
  • the holding element may consist of several individual parts which cooperate for receiving the sealing element, or the holding element may be formed integrally. It is particularly advantageous if the holding element describes a contour which rotates along the bottom of the at least one piercing opening. The holding element can thus introduce a bias on the arranged in the receptacle sealing element, which is directed to the respective puncture opening.
  • a decoupling of the retaining element from the wall can be provided that extends from the retaining element and the wall of the cup shape of the closure body formed space over the entire length of the contour.
  • the holding element passes through the sealing element and / or that the holding element engages along the contour on a circumference of the sealing element at least in sections.
  • the sealing element from several sides, preferably on all sides with respect to the bottom of the closure body, be held by the holding member to the closure body.
  • the holding element has ribs which engage the inserted sealing element and which are each oriented transversely to the extension direction of the circumference of the sealing element.
  • the holding element is formed as a wall.
  • An embodiment of the retaining element as a web can also be provided.
  • the retaining element has segments, which are each adapted to a portion of the circumference of the sealing element. These segments thus follow the circumference of the sealing element and engage in these sections of the sealing element.
  • the holding element may be formed, for example, as a continuous wall or as a continuous web.
  • the holding element is integrally formed with the closure body.
  • the sealing element is made of rubber material or TPE material.
  • the closure body can be made, for example, from a thermoplastic material, ie a fusible plastic.
  • a puncture opening may be used to introduce a drug into a dilution solution while the other puncture opening may be provided to remove the now diluted drug.
  • These puncture openings can be arranged in a common plane.
  • the holding element describes a contour which rotates the at least two puncture openings together.
  • the holding element forms a receptacle in which a sealing element can be arranged for both puncture openings.
  • the holding element forms a constriction in the receptacle for the sealing element in a region between the at least two puncture openings.
  • the advantage here is that by this constriction and a bias voltage can be introduced to the sealing element whose force component is substantially parallel to the connecting line of the puncture openings. This results in a substantially all-sided bias in the sealing element in the areas of the puncture openings.
  • Another advantage is that can be saved by the constriction material of the sealing element.
  • the holding element can thus be a spectacle-shaped or eight-shaped Describe contour, which is predetermined by the twin arrangement of the circular puncture openings.
  • a separate receptacle for a sealing element is formed by the holding element at each puncture opening of the closure body.
  • These sealing elements may be integrally connected to one another outside the respective receptacle.
  • the bottom of the cup shape of the closure in particular in the region of the edge of the puncture opening or puncture openings, covering part of the sealing element in the position of use of the closure to the outside.
  • the holding element maintains a minimum distance from the puncture opening, in particular from the circumference or edge of the puncture opening.
  • the sealing element is limited in one of the at least one puncture opening adjacent region of the bottom end face.
  • the advantage here is that bulging of the sealing element is avoided when expanding the cap. It is particularly advantageous if the area surrounds the pierceable opening or it borders.
  • the sealing element is arranged axially spaced from the wall. The advantage here is that the sealing element is mechanically decoupled from the wall, so that expanding or relieving deformation forces that are applied by the wall, for example in a thermal treatment, not or only reduced transferred to the sealing element.
  • the invention is advantageously applicable to an infusion container in which the closure of the infusion container is designed according to the invention.
  • FIG. 1 shows a generally designated 1 closure for a sterile medicament container according to the prior art in a sectional view, wherein the sectional plane is selected so that it is perpendicular to the plane defined by the opening of the medicament container level.
  • the closure 1 has a closure body 2, which is made of a hard, so non-elastic, material.
  • This closure body 2 forms a pot shape with a flat or flat bottom 3 and a wall 5 adjoining the bottom 3.
  • the wall 5 On the wall 5, another wall 4 connects.
  • the wall 5 has a diameter receded from the wall 4, whereby a shoulder 13 is formed between the wall 4 and the wall 5.
  • the bottom 3 and the wall 5 form a receptacle 6 for a Seal element 7 made of TPE material.
  • the sealing element 7 closes from the inside in the FIG. 1 no further evident, as in the embodiment of Figure 7 trained puncture openings 8.
  • the part of the sealing element 7 located behind the puncture openings 8 in the use position of the closure 1 is accessible from the outside.
  • liquids can be added to or taken out of the medicament container by passing a cannula or needle or the like through the puncture opening 8 and the sealing element 7 arranged behind it.
  • the hole remaining in the sealing element 7 after removal of the cannula or needle or the like is automatically closed again. This is achieved in that the sealing element 7 is arranged under prestress in the receptacle 6.
  • FIG. 2 shows an exemplary sectional view through such a deformed closure.
  • FIG. 3 shows another known from the prior art closure 1, which essentially like the closure 1 according to FIG. 1 is constructed, but to improve the retention of the sealing element 7 in the closure body 2, the sealing element 7 is connected at its periphery 9 cohesively with the wall 5.
  • FIG. 5 shows an inventive embodiment of a closure 1 in a sectional view, wherein the sectional plane as in the FIGS. 1 to 4 is selected.
  • the closure 1 according to FIG. 5 has a prefabricated, hard closure body 2.
  • This closure body 2 made of a thermoplastic, non-elastic material has - as by comparison with FIG. 7 becomes clear - an oval pot shape with a flat or flat bottom 3 and a subsequent to this floor 3 wall 5.
  • the closure 1 has the same appearance as the closures according to Figure 1 to 4 ,
  • the closure body 2 On its inside in the position of use facing the interior of the medication container inside, however, the closure body 2 additionally has a holding element 11, through which a receptacle 12 for the sealing element 7 is formed.
  • the holding element 11 is inwardly from the bottom 3 of the cup-shaped closure body 2 from.
  • the sealing element 7 is made of an elastic-soft material and closes two in FIG. 7 closer apparent piercing openings 8, which are formed in the bottom 3 of the closure body 2.
  • the sealing element 7 is made of TPE material, for example. It is also a sealing element 7 made of rubber or other elastic material used.
  • FIG. 6 shows an exemplary sectional view through the closure 1 according to FIG. 5 after deformation due to thermal Stress.
  • FIG. 7 shows a three-dimensional side view of the outside of the closure body. 2
  • the closure body 2 has a cup shape, which is formed by the bottom 3 and the walls 4 and 5.
  • the closure body 2 is withdrawn in its diameter in the region of the wall 5 relative to the wall 4, whereby a shoulder 13 is formed.
  • the bottom 3 and the shoulder 13 thus form end faces and are axially oriented, while the walls 4 and 5 form radially aligned surfaces.
  • the wall 5 with the bottom 3 are thus pot-shaped out of the shoulder 13.
  • puncture openings 8 are introduced, through which for filling or for the removal of liquids cannulas or the like are performed.
  • the puncture openings 8 are arranged in a twin arrangement.
  • FIG. 8 shows a three-dimensional view of the in use position of the closure 1 inner part of the cap. 2
  • the wall 4 forms a further pot shape with the shoulder 13, wherein the shoulder 13 represents the bottom of this further pot shape.
  • the shoulder 13 represents the bottom of this further pot shape.
  • first pot shape is embedded.
  • the holding element 11 projects from the bottom 3 and thus forms with the bottom 3 a receptacle 12 for the sealing element 7, which in FIG. 8 is not apparent.
  • the holding element 11 is formed as a wall and describes a contour which surrounds the puncture openings 8 together.
  • the bottom 3 extends on both sides of the holding element 11, whereby in the region of the edge of the puncture openings 8 a part of the sealing element 7 arranged in the receptacle 12 is covered outwards.
  • the holding element 11 holds a minimum distance 17 from the puncture openings 8. Since the holding element 11 extends around the two puncture openings 8 like a spectacle, the distance of the holding element 11 from the puncture openings 8 in the area between the puncture openings 8 is greater than the minimum distance 17. This minimum distance 17 for each puncture opening 8 surrounds the puncture opening 8 and covers it Area formed by the bottom 3, which is the Sealing element 7 in the position of use in the receptacle 12 frontally limited to the outside, so that it does not fall out or can bulge outward.
  • the contour which describes the holding element 11 is chosen to match the dimensions of the sealing element 7.
  • the inserted or injected sealing element 7 thus comes along its entire circumference 9 with the holding element 11 in touching contact.
  • the holding element 11 thus acts on these contact points on the sealing element 7 and holds this.
  • the holding member 11 is integrally formed as protruding from the bottom wall 3 with the closure body 2.
  • the holding element 11 is spaced from the wall 5 along the contour described by the holding element 11 and thus forms a gap 16 with the wall 5. Holding element 11 and wall 5 thus close the intermediate space 16.
  • This gap 16 serves to compensate for the deformation forces in the closure body 2, whereby the resulting deformation does not act on the shape of the holding element 11.
  • the gap 16 extends over the entire length of the contour described by the holding member 11.
  • a constriction 14 is formed in the region of the receptacle 12 which is arranged between the puncture openings 8.
  • This constriction 14 has the effect that a force component, which runs essentially parallel to the connecting line of the centers of the puncture openings 8 or with this line at an acute angle, preferably of less than 45, can be introduced to the sealing element 7 in the region of the puncture openings 8 via a pretension °, includes.
  • the sealing element 7 is frictionally connected in the receptacle 12 with the closure body 2, since due to the bias of the sealing element 7, the static friction between the periphery 9 of the sealing element and the holding member 11 is increased.
  • FIG. 9 shows a further inventive embodiment of a closure cap 2.
  • the closure body 2 according to Figure 9 differs from the closure body 2 according to FIG. 8 in that the holding element 11 is formed from a plurality of separate segments 15, which jointly describe a contour which surrounds the two puncture openings 8.
  • the individual segments 15 of the retaining element 11 engage in each case against a section of the circumference 9 of the sealing element 7.
  • the segments 15 are adapted in their shape in each case to a portion of the circumference 9 of the sealing element 7.
  • the contour described by the holding element 11, which surrounds the puncture openings 8 together, is identical to the contour of the holding element 11 according to FIG. 8 ,
  • the holding member 11 also forms a constriction 14 in the region of the receptacle 12 between the puncture openings 8 for the purpose described above.
  • the contour and thus the segments 15 maintain a minimum distance 17 to the puncture openings 8, which is greater than zero.
  • a puncture opening 8 enclosing and bounding area of the bottom 3 is formed for each puncture opening 8, which limits the sealing element 7 in the position of use in the receptacle 12 frontally to the outside, so that it can not fall out or bulge outward.
  • the holding element 11 is spaced from the wall 5 of the cup-shaped closure body 2, whereby between the segments 15 and the wall 5 each intermediate spaces 16 are formed.
  • the segments 15 are decoupled from movements of the wall 5, for example thermal deformations, and deformation forces in the closure body 2 are essentially not transmitted to the holding element 11 and therefore do not substantially change the shape of the receptacle 12 Sealing element 7 even in this embodiment, even then held securely on the closure body 2 and receives even then its bias when the rest of the closure body 2 deforms.
  • the holding element 11 is formed independently of the wall 5.
  • sealing element 7 If the sealing element 7 is injected into the receptacle 12, material of the sealing element 7 also passes through the gaps between the segments 15 into the area between the holding element 11 and the wall 5. In this case, the segments 15 of the holding element 11 penetrate the sealing element 7 ,
  • a closure body 2 which is prefabricated from a non-elastic material, a pot shape with a bottom 3 and a wall 4, 5 on.
  • a puncture opening 8 is introduced, which is provided for the addition or removal of liquid drugs.
  • This puncture opening 8 is sealed by a sealing element 7.
  • the sealing element 7 is held in a receptacle 12, which is formed by the bottom 3 and one of this bottom 3 in the position of use of the closure 1 inwardly projecting retaining element 11.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)

Description

Die Erfindung betrifft einen Verschluss für ein vorzugsweise steriles Medikamentenbehältnis, welcher Verschluss zur Verbindung mit dem Medikamentenbehältnis durch Erwärmen thermisch verformbar ist, einen vorgefertigten Verschlusskörper aufweist, welcher topfförmig mit einem Boden und einer Wand ausgebildet ist, und der im Boden seiner Topfform wenigstens eine Durchstichöffnung aufweist, wobei an diesem Verschlusskörper im Bereich des Bodens seiner Topfform ein elastisch-weiches Dichtelement derart angeordnet ist, dass die wenigstens eine Durchstichöffnung durch das Dichtelement verschlossen ist und ein Teil des Dichtelements in Gebrauchsstellung des Verschlusses von außen zugänglich ist, wobei der Verschlusskörper ein von der Wand unabhängiges Halteelement hat, welches in Gebrauchsstellung des Verschlusses nach innen von dem Boden des topfförmigen Verschlusskörpers absteht, und wobei durch das Halteelement eine Aufnahme für das Dichtelement gebildet ist und das Dichtelement in der Aufnahme angeordnet ist.The invention relates to a closure for a preferably sterile medicament container, which closure for connection to the medicament container is thermally deformable by heating, has a prefabricated closure body which is cup-shaped with a bottom and a wall, and which has at least one puncture opening in the bottom of its cup shape , wherein at this closure body in the region of the bottom of its cup shape, an elastic-soft sealing element is arranged such that the at least one puncture opening is closed by the sealing element and a part of the sealing element in the use position of the closure is accessible from outside, wherein the closure body of the Wall independent holding element has, which protrudes in the position of use of the closure inwardly from the bottom of the cup-shaped closure body, and wherein a receptacle for the sealing element is formed by the holding element and the Dichtele ment is arranged in the recording.

Beispielsweise aus der DE 38 35 720 A1 sind Verschlüsse gemäß dem Oberbegriff des Anspruchs 1 vorbekannt, die dadurch gefertigt werden, dass zunächst ein Verschlusskörper in Form einer Kappe hergestellt wird und in einem weiteren Herstellungsschritt im selben Werkzeug oder einem Teil davon das elastisch-weiche Dichtelement in die Kappe eingespritzt wird. Diese Verschlüsse haben sich in der Praxis bewährt.For example, from the DE 38 35 720 A1 closures are previously known according to the preamble of claim 1, which made it be that first a closure body is produced in the form of a cap and in a further manufacturing step in the same tool or a part thereof, the elastic-soft sealing element is injected into the cap. These closures have proven themselves in practice.

Es hat sich herausgestellt, dass derartige Verschlüsse im Verlauf der weiteren Verarbeitung, insbesondere bei Montage auf dem Medikamentenbehältnis, welches beispielsweise eine Flasche sein kann, und der anschließenden Wärmebehandlung zur Sterilisation, dem Autoklavieren, in weiten Bereichen starken Verformungskräften ausgesetzt sind, die einen sicheren Halt des Dichtelements und gegebenenfalls dessen ursprüngliche Vorspannung beeinträchtigen können. Es ist/sind daher bislang eine Nachkontrolle des fertig montierten Verschlusses und/oder ein erhöhter Aufwand bei der Verbindung des Dichtelements mit dem Verschlusskörper erforderlich.It has been found that such closures in the course of further processing, in particular when mounted on the medicament container, which may be a bottle, for example, and the subsequent heat treatment for sterilization, autoclaving, are exposed to strong deformation forces in many areas, the secure hold may affect the sealing element and possibly its original bias. It is / are therefore so far a follow-up of the fully assembled closure and / or increased effort in the connection of the sealing element with the closure body required.

Beispielsweise ist in der DE 38 35 720 A1 vorgesehen, dass das Dichtelement in den Verschlusskörper eingespritzt wird, wodurch ein großflächiger Verbindungsbereich zwischen Dichtelement und Verschlusskörper entsteht, und dass die durch den Verschluss verschlossene Medikamentenflasche an ihrer Flaschenmündung einen mit der Medikamentenflasche einstückig verbundenen Flaschendeckel aufweist, an welchem das Dichtelement im unbenutzten Zustand dichtend an dem Flaschendeckel anliegt und durch diesen zumindest teilweise abgestützt wird. Die Fertigung einer derartigen Anordnung erfordert jedoch aufwändiges Werkzeug.For example, in the DE 38 35 720 A1 provided that the sealing element is injected into the closure body, whereby a large area connection area between sealing element and closure body is formed, and that the closed by the closure medicine bottle has at its mouth a bottle cap integrally connected to the medicine bottle, to which the sealing element in the unused state sealingly the bottle cap rests and is supported by this at least partially. However, the production of such an arrangement requires complex tool.

Aus der vorangemeldeten, aber nach veröffentlichten WO 2009/0095488 A1 ist ein Verschluss der eingangs erwähnten Art bekannt, der zur Verbindung mit einem Medikamentenbehältnis durch Erwärmen thermisch verformbar ist und einen vorgefertigten Verschlusskörper aufweist, der topfförmig mit einem Boden und einer Wand ausgebildet ist. Im Boden des topfförmigen Verschlusskörpers ist ein elastisch-weiches Dichtelement derart angeordnet, dass die wenigstens eine Durchstichöffnung durch das Dichtelement verschlossen ist. Das Dichtelement ist in einem als Aufnahme dienenden Halteelement angeordnet, welches in Gebrauchsstellung des Verschlusses nach innen von dem Boden des topfförmigen Verschlusskörpers absteht. In der WO 2009/095488 A1 ist erwähnt, dass der durch das zylindrische Halteelement gebildete Hohlraum mit einem vorzugsweise mit Gummi hergestellten Dichtungsmaterial angefüllt sein kann.From the pre-registered, but after published WO 2009/0095488 A1 a closure of the type mentioned is known, which is thermally deformable for connection to a medicament container by heating and a has prefabricated closure body which is cup-shaped with a bottom and a wall. In the bottom of the cup-shaped closure body, an elastic-soft sealing element is arranged such that the at least one puncture opening is closed by the sealing element. The sealing element is arranged in a retaining element serving as a receptacle, which protrudes inward in the position of use of the closure from the bottom of the pot-shaped closure body. In the WO 2009/095488 A1 is mentioned that the cavity formed by the cylindrical holding member may be filled with a preferably rubber-made sealing material.

Das zylindrische Halteelement des aus WO 2009/0954881 A1 vorbekannten Verschlusses weist auch der dem Behälterinnenraum zugewandten Stirnseite eine Außen- oder Bodenwand auf, die mittels einer Spritzkanüle durchstochen werden muss, derart, dass nach Entfernen der Kanüle ein Einstichloch in der Außenwand verbleibt.The cylindrical holding element of the WO 2009/0954881 A1 Prior art closure also has the end facing the container interior an outer or bottom wall, which must be pierced by means of a spray cannula, such that after removal of the cannula a puncture hole remains in the outer wall.

Der vorliegenden Erfindung liegt die Aufgabe zugrunde, einen Verschluss für ein insbesondere steriles Medikamentenbehältnis zu schaffen, bei welchem der Halt des Dichtelements an der Verschlusskappe verbessert ist.The present invention has for its object to provide a closure for a particularly sterile medication container, in which the maintenance of the sealing element is improved on the cap.

Zur Lösung dieser Aufgabe ist bei einem Verschluss der eingangs genannten Art vorgesehen, dass das Dichtelement vorgefertigt, in die Aufnahme eingesetzt und darin unter Vorspannung gehalten ist, und dass das Dichtelement mit dem Verschlusskörper stoffschlüssig verbunden ist.To achieve this object, it is provided in a closure of the type mentioned that the sealing element is prefabricated, inserted into the receptacle and held therein under prestress, and that the sealing element is materially connected to the closure body.

Dadurch, dass das Halteelement von dem Boden des topfförmigen Verschlusskörpers absteht und unabhängig von der Wand der Topfform ist, werden die oben beschriebenen, in dem Verschlusskörper wirkenden Verformungskräfte nicht auf die durch das Halteelement gebildete Aufnahme übertragen, wodurch die Befestigung des Dichtelements in der Aufnahme nicht beeinträchtigt wird. Somit ist der Halt des Dichtelements an dem Verschlusskörper verbessert. Erfindungsgemäß ist vorgesehen, dass das Dichtelement vorgefertigt, in die Aufnahme eingesetzt und darin unter Vorspannung gehalten ist. Von Vorteil ist dabei, dass ein in Gebrauch mit einer Kanüle oder Nadel in das Dichtelement eingebrachtes Durchstichloch durch die Vorspannung des Dichtelements nach Gebrauch selbsttätig verschlossen werden kann. Um einen verbesserten Halt des Dichtelements an dem Verschlusskörper vorzusehen, ist das Dichtelement mit dem Verschlusskörper stoffschlüssig, beispielsweise durch Einspritzen, Kleben oder Schweißen, verbunden.Characterized in that the holding element protrudes from the bottom of the pot-shaped closure body and regardless of the wall of the Is pot shape, the above-described, acting in the closure body deformation forces are not transmitted to the receptacle formed by the holding member, whereby the attachment of the sealing element is not affected in the recording. Thus, the maintenance of the sealing element on the closure body is improved. According to the invention it is provided that the sealing element is prefabricated, inserted into the receptacle and held therein under prestress. The advantage here is that an inserted in use with a cannula or needle in the sealing element puncture hole can be automatically closed by the bias of the sealing element after use. In order to provide an improved hold of the sealing element on the closure body, the sealing element with the closure body is materially connected, for example by injection, gluing or welding.

Der Verschlusskörper kann aus nicht-elastischem Material, beispielsweise einem Hartkunststoff, bestehen.The closure body may consist of non-elastic material, for example a hard plastic.

Die Durchstichöffnungen können vor Gebrauch durch abnehmbare Abdeckungen von außen verschlossen sein.The puncture openings may be closed from outside by removable covers before use.

Vorzugsweise ist der Boden flach oder eben ausgebildet. Es kann aber auch ein nach außen oder innen gewölbter Boden verwendet werden.Preferably, the bottom is flat or flat. But it can also be used a curved outward or inward floor.

Das Medikamentenbehältnis kann beispielsweise eine Flasche oder ein Beutel oder ein allgemeines Behältnis für vorzugsweise flüssige Medikamente sein. Im Gebrauch wird das Medikamentenbehältnis häufig gestürzt aufgestellt oder aufgehängt, sodass der Boden der Topfform des Verschlusskörpers unter dessen Wand angeordnet ist.The medicament container may, for example, be a bottle or a pouch or a general container for preferably liquid medicaments. In use, the medication container is often placed down or suspended, so that the bottom of the cup shape of the closure body is disposed under the wall.

Eine besonders gute Entkopplung des Halteelements von den Verformungskräften, die bei thermischer Beanspruchung des Verschlusskörpers in den Verschlusskörper eingebracht werden, wird erreicht, wenn das Halteelement von der Wand der Topfform des Verschlusskörpers beabstandet ist und mit dieser zumindest abschnittsweise, vorzugsweise über die gesamte Erstreckung des Halteelements auf dem Boden der Topfform, einen Zwischenraum bildet.A particularly good decoupling of the retaining element from the deformation forces, which are introduced under thermal stress of the closure body in the closure body, is achieved when the holding element is spaced from the wall of the cup shape of the closure body and with this at least in sections, preferably over the entire extension of the holding element on the bottom of the pot shape, forming a gap.

Das Halteelement kann aus mehreren Einzelteilen bestehen, die zur Aufnahme des Dichtelements zusammenwirken, oder das Halteelement kann einstückig ausgebildet sein. Besonders günstig ist es dabei, wenn das Halteelement eine Kontur beschreibt, welche die wenigstens eine Durchstichöffnung entlang des Bodens umläuft. Das Halteelement kann somit eine Vorspannung auf das in der Aufnahme angeordnete Dichtelement einbringen, die auf die jeweilige Durchstichöffnung gerichtet ist.The holding element may consist of several individual parts which cooperate for receiving the sealing element, or the holding element may be formed integrally. It is particularly advantageous if the holding element describes a contour which rotates along the bottom of the at least one piercing opening. The holding element can thus introduce a bias on the arranged in the receptacle sealing element, which is directed to the respective puncture opening.

Für eine möglichst vollständige Entkoppelung des Halteelements von der Wand kann vorgesehen sein, dass sich der von dem Halteelement und der Wand der Topfform des Verschlusskörpers gebildete Zwischenraum über die gesamte Länge der Kontur erstreckt.For as complete a decoupling of the retaining element from the wall can be provided that extends from the retaining element and the wall of the cup shape of the closure body formed space over the entire length of the contour.

Es kann vorgesehen sein, dass das Haltelement das Dichtelement durchsetzt und/oder dass das Halteelement entlang der Kontur an einem Umfang des Dichtelements zumindest abschnittsweise angreift. Somit kann das Dichtelement von mehreren Seiten, vorzugsweise allseitig in bezug auf den Boden des Verschlusskörpers, durch das Halteelement an dem Verschlusskörper gehalten sein.It can be provided that the holding element passes through the sealing element and / or that the holding element engages along the contour on a circumference of the sealing element at least in sections. Thus, the sealing element from several sides, preferably on all sides with respect to the bottom of the closure body, be held by the holding member to the closure body.

Beispielsweise kann vorgesehen sein, dass das Halteelement Rippen aufweist, die an dem eingesetzten Dichtelement angreifen und die jeweils quer zur Erstreckungsrichtung des Umfangs des Dichtelements orientiert sind. Durch die Ausbildung von Rippen wird eine nochmals verbesserte Stabilität des Halteelements gegenüber Verformungskräften, die in den Verschlusskörper eingebracht werden, erreicht.For example, it can be provided that the holding element has ribs which engage the inserted sealing element and which are each oriented transversely to the extension direction of the circumference of the sealing element. By the formation of ribs, a further improved stability of the holding element with respect to deformation forces, which are introduced into the closure body, is achieved.

Alternativ oder zusätzlich kann vorgesehen sein, dass das Halteelement als Wandung ausgebildet ist. Auch eine Ausbildung des Halteelements als Steg kann vorgesehen sein.Alternatively or additionally, it may be provided that the holding element is formed as a wall. An embodiment of the retaining element as a web can also be provided.

Beispielsweise kann vorgesehen sein, dass das Halteelement Segmente aufweist, die jeweils an einen Abschnitt des Umfangs des Dichtelements angepasst sind. Diese Segmente folgen somit dem Umfang des Dichtelements und greifen in diesen Abschnitten an das Dichtelement an.For example, it can be provided that the retaining element has segments, which are each adapted to a portion of the circumference of the sealing element. These segments thus follow the circumference of the sealing element and engage in these sections of the sealing element.

Besonders günstig ist es dabei, wenn diese Segmente untereinander verbunden sind und das Halteelement somit entlang des gesamten Umfangs des Dichtelements an dem Dichtelement angreift. Das Halteelement kann beispielsweise als durchgängige Wandung oder als durchgängiger Steg ausgebildet sein.It is particularly advantageous if these segments are interconnected and thus engages the holding element along the entire circumference of the sealing element on the sealing element. The holding element may be formed, for example, as a continuous wall or as a continuous web.

Für eine besonders kostengünstige Fertigung des Verschlusses kann vorgesehen sein, dass das Halteelement mit dem Verschlusskörper einstückig ausgebildet ist.For a particularly cost-effective production of the closure can be provided that the holding element is integrally formed with the closure body.

Für eine kostengünstige Fertigung des Verschlusses kann vorgesehen sein, dass das Dichtelement aus Gummimaterial oder aus TPE-Material gefertigt ist.For a cost-effective production of the closure can be provided that the sealing element is made of rubber material or TPE material.

Der Verschlusskörper kann beispielsweise aus einem thermoplastischen Material, also einem schmelzbaren Kunststoff, gefertigt sein.The closure body can be made, for example, from a thermoplastic material, ie a fusible plastic.

Günstige Gebrauchseigenschaften des Verschlusses werden erreicht, wenn der Verschlusskörper im Boden seiner Topfform wenigstens zwei Durchstichöffnungen aufweist, welche durch das Dichtelement oder jeweils durch ein Dichtelement verschlossen sind, wobei durch jede Durchstichöffnung jeweils ein Teil eines oder des Dichtelements in Gebrauchstellung des Verschlusses zugänglich ist. Beispielsweise ist eine Durchstichöffnung zum Einbringen eines Medikaments in eine Verdünnungslösung verwendbar, während die andere Durchstichöffnung zur Entnahme des nun verdünnten Medikaments vorgesehen sein kann.Favorable use properties of the closure are achieved when the closure body has at least two puncture openings in the bottom of its cup shape, which are closed by the sealing element or in each case by a sealing element, wherein each part of one or of the sealing element in the use position of the closure is accessible through each puncture opening. For example, a puncture opening may be used to introduce a drug into a dilution solution while the other puncture opening may be provided to remove the now diluted drug.

Diese Durchstichöffnungen können in einer gemeinsamen Ebene angeordnet sein.These puncture openings can be arranged in a common plane.

Gemäß einer Ausgestaltung der Erfindung kann vorgesehen sein, dass das Halteelement eine Kontur beschreibt, welche die wenigstens zwei Durchstichöffnungen gemeinsam umläuft. Somit wird vorteilhaft erreicht, dass das Halteelement eine Aufnahme bildet, in welcher ein Dichtelement für beide Durchstichöffnungen angeordnet werden kann.According to one embodiment of the invention can be provided that the holding element describes a contour which rotates the at least two puncture openings together. Thus, it is advantageously achieved that the holding element forms a receptacle in which a sealing element can be arranged for both puncture openings.

Gemäß einer Ausgestaltung der Erfindung kann vorgesehen sein, dass das Halteelement in einem Bereich zwischen den wenigstens zwei Durchstichöffnungen eine Verengung in der Aufnahme für das Dichteelement bildet. Von Vorteil ist dabei, dass durch diese Verengung auch eine Vorspannung auf das Dichtelement eingebracht werden kann, deren Kraftkomponente im Wesentlichen parallel zu der Verbindungslinie der Durchstichöffnungen verläuft. Somit ergibt sich eine im wesentlichen allseitige Vorspannung im Dichtelement in den Bereichen der Durchstichöffnungen. Von Vorteil ist weiter, dass durch die Verengung Material des Dichtelements eingespart werden kann. Das Halteelement kann somit eine brillenförmige oder achtförmige Kontur beschreiben, welche durch die Zwillingsanordnung der kreisrunden Durchstichöffnungen vorgegebenen ist.According to one embodiment of the invention, it may be provided that the holding element forms a constriction in the receptacle for the sealing element in a region between the at least two puncture openings. The advantage here is that by this constriction and a bias voltage can be introduced to the sealing element whose force component is substantially parallel to the connecting line of the puncture openings. This results in a substantially all-sided bias in the sealing element in the areas of the puncture openings. Another advantage is that can be saved by the constriction material of the sealing element. The holding element can thus be a spectacle-shaped or eight-shaped Describe contour, which is predetermined by the twin arrangement of the circular puncture openings.

Alternativ kann vorgesehen sein, dass durch das Halteelement an jeder Durchstichöffnung des Verschlussköpers eine separate Aufnahme für ein Dichtelement ausgebildet ist. Diese Dichtelemente können außerhalb der jeweiligen Aufnahme einstückig miteinander verbunden sein.Alternatively, it can be provided that a separate receptacle for a sealing element is formed by the holding element at each puncture opening of the closure body. These sealing elements may be integrally connected to one another outside the respective receptacle.

Für einen besonders festen Halt des Dichtelements an dem Boden des Verschlusskörpers kann vorgesehen sein, dass der Boden der Topfform des Verschlusses, insbesondere im Bereich des Randes der Durchstichöffnung oder der Durchstichöffnungen, einen Teil des Dichtelements in Gebrauchsstellung des Verschlusses nach außen abdeckt. Vorzugsweise kann vorgesehen sein, dass das Halteelement einen Mindestabstand von der Durchstichöffnung, insbesondere vom Umfang oder Rand der Durchstichöffnung, einhält.For a particularly firm hold of the sealing element at the bottom of the closure body can be provided that the bottom of the cup shape of the closure, in particular in the region of the edge of the puncture opening or puncture openings, covering part of the sealing element in the position of use of the closure to the outside. Preferably, it can be provided that the holding element maintains a minimum distance from the puncture opening, in particular from the circumference or edge of the puncture opening.

Bei einer Ausgestaltung der Erfindung kann vorgesehen sein, dass das Dichtelement in einem der wenigstens einen Durchstichöffnung benachbarten Bereich von dem Boden stirnseitig begrenzt ist. Von Vorteil ist dabei, dass ein Auswölben des Dichtelementes bei Aufdehnen der Kappe vermieden wird. Besonders günstig ist es dabei, wenn der Bereich die Durchstichöffnung umschließt oder sie berandet. Bei einer Ausgestaltung der Erfindung kann vorgesehen sein, dass das Dichtelement von der Wand axial beabstandet angeordnet ist. Von Vorteil ist dabei, dass das Dichtelement von der Wand mechanisch entkoppelt ist, so dass aufweitende oder entlastende Verformungskräfte, die von der Wand beispielsweise bei einer thermischen Behandlung aufgebracht werden, nicht oder nur vermindert auf das Dichtelement übertragen werden.In one embodiment of the invention can be provided that the sealing element is limited in one of the at least one puncture opening adjacent region of the bottom end face. The advantage here is that bulging of the sealing element is avoided when expanding the cap. It is particularly advantageous if the area surrounds the pierceable opening or it borders. In one embodiment of the invention can be provided that the sealing element is arranged axially spaced from the wall. The advantage here is that the sealing element is mechanically decoupled from the wall, so that expanding or relieving deformation forces that are applied by the wall, for example in a thermal treatment, not or only reduced transferred to the sealing element.

Die Erfindung ist mit Vorteil bei einem Infusionsbehälter anwendbar, bei dem der Verschluss des Infusionsbehälters erfindungsgemäß ausgebildet ist.The invention is advantageously applicable to an infusion container in which the closure of the infusion container is designed according to the invention.

Die Erfindung wird nun anhand von Ausführungsbeispielen beschrieben, ist aber nicht auf diese Ausführungsbeispiele beschränkt. Weitere Ausführungsbeispiele ergeben sich durch Kombination der Merkmale der Ausführungsbeispiele untereinander und/oder mit Merkmalen der Patentansprüche.The invention will now be described with reference to embodiments, but is not limited to these embodiments. Further embodiments result from combining the features of the embodiments with each other and / or with features of the claims.

Es zeigt:

Figur 1
eine Schnittansicht eines Verschlusses nach dem Stand der Technik,
Figur 2
eine Schnittansicht des Verschlusses gemäß Figur 1 nach thermischer Beanspruchung,
Figur 3
eine Schnittansicht eines weiteren Verschlusses nach dem Stand der Technik,
Figur 4
eine Schnittansicht des Verschlusses gemäß Figur 3 nach thermischer Beanspruchung,
Figur 5
eine Schnittansicht eines erfindungsgemäßen Verschlusses,
Figur 6
eine Schnittansicht des Verschlusses gemäß Figur 5 nach thermischer Beanspruchung,
Figur 7
eine dreidimensionale Ansicht von außen des Verschlusses gemäß Figur 5,
Figur 8
eine dreidimensionale Ansicht der Innenseite des Verschlusses gemäß Figur 5 und
Figur 9
eine dreidimensionale Ansicht der Innenseite eines weiteren erfindungsgemäßen Verschlusses.
It shows:
FIG. 1
a sectional view of a closure according to the prior art,
FIG. 2
a sectional view of the closure according to FIG. 1 after thermal stress,
FIG. 3
a sectional view of another closure according to the prior art,
FIG. 4
a sectional view of the closure according to FIG. 3 after thermal stress,
FIG. 5
a sectional view of a closure according to the invention,
FIG. 6
a sectional view of the closure according to FIG. 5 after thermal stress,
FIG. 7
a three-dimensional view from the outside of the closure according to FIG. 5 .
FIG. 8
a three-dimensional view of the inside of the closure according to FIG. 5 and
FIG. 9
a three-dimensional view of the inside of another closure according to the invention.

Figur 1 zeigt einen im Ganzen mit 1 bezeichneten Verschluss für ein steriles Medikamentenbehältnis nach dem Stand der Technik in einer Schnittansicht, wobei die Schnittebene so gewählt ist, dass sie senkrecht auf der durch die Öffnung des Medikamentenbehältnisses definierten Ebene steht. FIG. 1 shows a generally designated 1 closure for a sterile medicament container according to the prior art in a sectional view, wherein the sectional plane is selected so that it is perpendicular to the plane defined by the opening of the medicament container level.

Der Verschluss 1 weist einen Verschlusskörper 2 auf, der aus einem harten, also nicht-elastischen, Material gefertigt ist. Dieser Verschlusskörper 2 bildet mit einem flach oder eben ausgeführten Boden 3 und einer sich an den Boden 3 anschließenden Wand 5 eine Topfform.The closure 1 has a closure body 2, which is made of a hard, so non-elastic, material. This closure body 2 forms a pot shape with a flat or flat bottom 3 and a wall 5 adjoining the bottom 3.

An die Wand 5 schließt sich eine weitere Wand 4 an. Die Wand 5 weist einen gegenüber der Wand 4 zurückgenommenen Durchmesser auf, wodurch eine Schulter 13 zwischen Wand 4 und Wand 5 ausgebildet ist.On the wall 5, another wall 4 connects. The wall 5 has a diameter receded from the wall 4, whereby a shoulder 13 is formed between the wall 4 and the wall 5.

Der Boden 3 und die Wand 5 formen eine Aufnahme 6 für ein Dichtelement 7 aus TPE-Material.The bottom 3 and the wall 5 form a receptacle 6 for a Seal element 7 made of TPE material.

Das Dichtelement 7 verschließt von innen in der Figur 1 nicht weiter ersichtliche, wie bei dem Ausführungsbeispiel gemäß Figur 7 ausgebildete Durchstichöffnungen 8. Hierbei ist der hinter den Durchstichöffnungen 8 liegende Teil des Dichtelements 7 in Gebrauchsstellung des Verschlusses 1 von außen zugänglich.The sealing element 7 closes from the inside in the FIG. 1 no further evident, as in the embodiment of Figure 7 trained puncture openings 8. Here, the part of the sealing element 7 located behind the puncture openings 8 in the use position of the closure 1 is accessible from the outside.

Somit können Flüssigkeiten in das Medikamentenbehältnis gegeben beziehungsweise aus diesem entnommen werden, indem eine Kanüle oder Nadel oder dergleichen durch die Durchstichöffnung 8 und das dahinter angeordnete Dichtelement 7 geführt wird.Thus, liquids can be added to or taken out of the medicament container by passing a cannula or needle or the like through the puncture opening 8 and the sealing element 7 arranged behind it.

Um die Sterilität des Medikamentenbehältnisses zu erhalten, ist es wünschenswert, dass das nach Entfernen der Kanüle oder Nadel oder dergleichen in dem Dichtelement 7 verbleibende Loch selbsttätig wieder verschlossen wird. Dies wird dadurch erreicht, dass das Dichtelement 7 unter Vorspannung in der Aufnahme 6 angeordnet ist.In order to maintain the sterility of the medicament container, it is desirable that the hole remaining in the sealing element 7 after removal of the cannula or needle or the like is automatically closed again. This is achieved in that the sealing element 7 is arranged under prestress in the receptacle 6.

Bei der Fertigung des Medikamentenbehältnisses und insbesondere zur Verbindung des Verschlusses 1 mit einem nicht weiter dargestellten Medikamentenbehältnis ist es erforderlich, den Verschluss zu erwärmen. Durch diese thermische Beanspruchung werden in den Verschlusskörper 2 Verformungskräfte eingebracht, die zu einer Verformung des Verschlusskörpers 2 führen.In the manufacture of the medicament container and in particular for the connection of the closure 1 with a medicament container, not shown, it is necessary to heat the closure. As a result of this thermal stress, deformation forces are introduced into the closure body 2, which lead to a deformation of the closure body 2.

Figur 2 zeigt eine beispielhafte Schnittansicht durch einen solcherart verformten Verschluss 1. FIG. 2 shows an exemplary sectional view through such a deformed closure. 1

Es ist ersichtlich, dass die Verformung zu einer Änderung des Durchmessers der Wand 5 und der Wand 4 geführt hat, während der flache Boden 3 der Topfform des Verschlusskörpers 2 im Wesentlichen unbeeinträchtigt geblieben ist.It can be seen that the deformation has led to a change in the diameter of the wall 5 and the wall 4, while the flat bottom 3 of the cup shape of the closure body 2 substantially remained undisturbed.

Diese Verformung der Wand 5 führt - wie aus Figur 2 ersichtlich ist - dazu, dass zwischen dem Umfang 9 des Dichtelements 7 und der Wand 5 ein ringförmiger Spalt 10 klafft, sodass das Dichtelement 7 nicht mehr durch die Wand 5 des topfförmigen Verschlusskörpers 2 gehalten ist.This deformation of the wall 5 leads - as from FIG. 2 it can be seen - to the fact that between the circumference 9 of the sealing element 7 and the wall 5, an annular gap 10 gap, so that the sealing element 7 is no longer held by the wall 5 of the cup-shaped closure body 2.

Es besteht somit die Gefahr, dass das Dichtelement 7 während des Durchstechens mit einer Kanüle von dem Boden 3 der Topfform des Verschlusskörpers 2 losgerissen wird, wodurch die Sterilität des Innenraums des Medikamentenbehältnisses nicht mehr garantiert ist.There is thus the risk that the sealing element 7 is torn off during piercing with a cannula of the bottom 3 of the cup shape of the closure body 2, whereby the sterility of the interior of the medicament container is no longer guaranteed.

Figur 3 zeigt einen weiteren aus dem Stand der Technik bekannten Verschluss 1, der im Wesentlichen wie der Verschluss 1 gemäß Figur 1 aufgebaut ist, wobei aber zur Verbesserung des Haltes des Dichtelements 7 in den Verschlusskörper 2 das Dichtelement 7 an seinem Umfang 9 stoffschlüssig mit der Wand 5 verbunden ist. FIG. 3 shows another known from the prior art closure 1, which essentially like the closure 1 according to FIG. 1 is constructed, but to improve the retention of the sealing element 7 in the closure body 2, the sealing element 7 is connected at its periphery 9 cohesively with the wall 5.

Durch diese Verbindung wird die Herausbildung eines Spaltes 10 wie in Figur 2 bei einer thermischen Verformung des Verschlusses 1 verhindert.Through this connection, the formation of a gap 10 as in FIG. 2 prevented in a thermal deformation of the closure 1.

Bei diesem Verschluss 1 werden jedoch die Verformungskräfte über die Wand 5 auf das Dichtelement 7 eingebracht, wodurch dieses im Bereich der Durchtrittsöffnungen 8 auf Zug belastet wird und sich entsprechend verformt.In this closure 1, however, the deformation forces on the wall 5 are introduced to the sealing element 7, whereby this is loaded in the region of the passage openings 8 to train and deformed accordingly.

Diese Verformung hat zur Folge, dass eine Vorspannung verloren geht und dass somit ein selbsttätiges Verschließen von Durchstichkanälen in dem Dichtelement 7 nicht mehr gewährleistet ist.This deformation has the consequence that a bias voltage is lost and thus that an automatic closing of puncture channels in the sealing element 7 is no longer guaranteed is.

Figur 5 zeigt ein erfindungsgemäßes Ausführungsbeispiel eines Verschlusses 1 in einer Schnittansicht, wobei die Schnittebene wie bei den Figuren 1 bis 4 gewählt ist. FIG. 5 shows an inventive embodiment of a closure 1 in a sectional view, wherein the sectional plane as in the FIGS. 1 to 4 is selected.

Auch der Verschluss 1 gemäß Figur 5 hat einen vorgefertigten, harten Verschlusskörper 2. Dieser Verschlusskörper 2 aus einem thermoplastischen, nicht-elastischen Material weist - wie durch Vergleich mit Figur 7 deutlich wird - eine ovale Topfform mit einem ebenen oder flachen Boden 3 und einer sich an diesem Boden 3 anschließenden Wand 5 auf. An die Wand 5 schließt sich über eine Schulter 13 eine weitere Wand 4 von zylindrischer Grundform an. Der Verschluss 1 bietet dasselbe äußere Erscheinungsbild wie die Verschlüsse gemäß Figur 1 bis 4.Also, the closure 1 according to FIG. 5 has a prefabricated, hard closure body 2. This closure body 2 made of a thermoplastic, non-elastic material has - as by comparison with FIG. 7 becomes clear - an oval pot shape with a flat or flat bottom 3 and a subsequent to this floor 3 wall 5. To the wall 5 connects via a shoulder 13, a further wall 4 of cylindrical basic shape. The closure 1 has the same appearance as the closures according to Figure 1 to 4 ,

Auf seiner in Gebrauchsstellung dem Inneren des Medikamentenbehältnisses zugewandten Innenseite hat der Verschlusskörper 2 jedoch zusätzlich ein Halteelement 11, durch welches eine Aufnahme 12 für das Dichtelement 7 gebildet ist.On its inside in the position of use facing the interior of the medication container inside, however, the closure body 2 additionally has a holding element 11, through which a receptacle 12 for the sealing element 7 is formed.

Hierzu steht das Halteelement 11 nach Innen von dem Boden 3 des topfförmigen Verschlusskörpers 2 ab.For this purpose, the holding element 11 is inwardly from the bottom 3 of the cup-shaped closure body 2 from.

Das Dichtelement 7 ist aus einem elastisch-weichen Material gefertigt und verschließt zwei in Figur 7 näher ersichtliche Durchstichöffnungen 8, die im Boden 3 des Verschlusskörpers 2 ausgebildet sind. Das Dichtelement 7 ist beispielsweise aus TPE-Material gefertigt. Es ist auch ein Dichtelement 7 aus Gummi oder einem anderen elastischen Material verwendbar.The sealing element 7 is made of an elastic-soft material and closes two in FIG. 7 closer apparent piercing openings 8, which are formed in the bottom 3 of the closure body 2. The sealing element 7 is made of TPE material, for example. It is also a sealing element 7 made of rubber or other elastic material used.

Figur 6 zeigt eine beispielhafte Schnittansicht durch den Verschluss 1 gemäß Figur 5 nach Verformung aufgrund thermischer Beanspruchung. FIG. 6 shows an exemplary sectional view through the closure 1 according to FIG. 5 after deformation due to thermal Stress.

Zwar haben sich - wie bei den Beispielen gemäß Figur 1 bis 4 - die Wand 4 und die Wand 5 durch die Verformungskräfte aufgeweitet, jedoch hat sich diese Verformung nicht auf die Halteelemente 11 übertragen, weshalb die durch die von dem Boden 3 abstehenden Halteelemente 11 gebildete Aufnahme 12 ihre Gestalt nicht verändert hat. Der Sitz und Halt des Dichtelements 7 in der Aufnahme 12 ist somit durch die thermische Beanspruchung nicht beeinträchtigt.Although have - as in the examples according to Figure 1 to 4 - The wall 4 and the wall 5 widened by the deformation forces, but this deformation has not been transferred to the support members 11, which is why the receptacle 12 formed by the protruding from the bottom 3 holding elements 11 has not changed its shape. The seat and hold of the sealing element 7 in the receptacle 12 is thus not affected by the thermal stress.

Figur 7 zeigt eine dreidimensionale Seitenansicht auf die Außenseite des Verschlusskörpers 2. FIG. 7 shows a three-dimensional side view of the outside of the closure body. 2

Deutlich ist zu sehen, dass der Verschlusskörper 2 eine Topfform aufweist, die durch den Boden 3 und die Wände 4 und 5 gebildet ist. Der Verschlusskörper 2 ist in seinem Durchmesser im Bereich der Wand 5 gegenüber der Wand 4 zurückgenommen, wodurch eine Schulter 13 ausgebildet ist. Der Boden 3 und die Schulter 13 bilden somit stirnseitige Flächen und sind axial orientiert, während die Wände 4 und 5 radial ausgerichtete Flächen bilden.It can clearly be seen that the closure body 2 has a cup shape, which is formed by the bottom 3 and the walls 4 and 5. The closure body 2 is withdrawn in its diameter in the region of the wall 5 relative to the wall 4, whereby a shoulder 13 is formed. The bottom 3 and the shoulder 13 thus form end faces and are axially oriented, while the walls 4 and 5 form radially aligned surfaces.

Die Wand 5 mit dem Boden 3 stehen somit topfförmig aus der Schulter 13 hervor.The wall 5 with the bottom 3 are thus pot-shaped out of the shoulder 13.

In den Boden 3 sind zwei Durchstichöffnungen 8 eingebracht, durch welche zum Befüllen beziehungsweise zur Entnahme von Flüssigkeiten Kanülen oder dergleichen geführt werden. Die Durchstichöffnungen 8 sind in einer Zwillingsanordnung angeordnet.In the bottom 3, two puncture openings 8 are introduced, through which for filling or for the removal of liquids cannulas or the like are performed. The puncture openings 8 are arranged in a twin arrangement.

Zur Abdichtung der Durchstichöffnungen 8 ist hinter diesen Durchstichöffnungen 8 ein in Figur 7 nicht weiter ersichtliches Dichtelement 7 angeordnet, welches die Durchstichöffnungen 8 vollständig verschließt. Hierbei deckt der Boden 3 im Bereich des Randes der Durchstichöffnungen 8 einen Teil des Dichtelements 7 in Gebrauchsstellung des Verschlusses 1 nach außen ab.To seal the puncture openings 8 is behind these puncture openings 8 in FIG. 7 not further apparent Sealing element 7 is arranged, which completely closes the puncture openings 8. Here, the bottom 3 covers in the region of the edge of the puncture openings 8 a part of the sealing element 7 in the position of use of the closure 1 to the outside.

Figur 8 zeigt eine dreidimensionale Ansicht auf den in Gebrauchsstellung des Verschlusses 1 innenliegenden Teil der Verschlusskappe 2. FIG. 8 shows a three-dimensional view of the in use position of the closure 1 inner part of the cap. 2

Es ist ersichtlich, dass die Wand 4 mit der Schulter 13 eine weitere Topfform bildet, wobei die Schulter 13 den Boden dieser weiteren Topfform darstellt. In diesen Boden ist die aus Boden 3 und Wand 5 gebildete erste Topfform eingelassen.It can be seen that the wall 4 forms a further pot shape with the shoulder 13, wherein the shoulder 13 represents the bottom of this further pot shape. In this bottom of the bottom 3 and 5 wall formed first pot shape is embedded.

Das Halteelement 11 steht vom Boden 3 ab und bildet somit mit dem Boden 3 eine Aufnahme 12 für das Dichtelement 7, welches in Figur 8 nicht ersichtlich ist.The holding element 11 projects from the bottom 3 and thus forms with the bottom 3 a receptacle 12 for the sealing element 7, which in FIG. 8 is not apparent.

Das Halteelement 11 ist als Wandung ausgebildet und beschreibt eine Kontur, welche die Durchstichöffnungen 8 gemeinsam umläuft. Der Boden 3 erstreckt sich auf beiden Seiten des Halteelements 11, wodurch im Bereich des Randes der Durchstichöffnungen 8 ein Teil des in der Aufnahme 12 angeordneten Dichtelements 7 nach außen abgedeckt wird.The holding element 11 is formed as a wall and describes a contour which surrounds the puncture openings 8 together. The bottom 3 extends on both sides of the holding element 11, whereby in the region of the edge of the puncture openings 8 a part of the sealing element 7 arranged in the receptacle 12 is covered outwards.

Das Halteelement 11 hält einen Mindestabstand 17 von den Durchstichöffnungen 8 ein. Da das Halteelement 11 brillenförmig um die beiden Durchstichöffnungen 8 verläuft, ist der Abstand des Halteelements 11 von den Durchstichöffnungen 8 im Bereich zwischen den Durchstichöffnungen 8 größer als der Mindestabstand 17. Durch diesen Mindestabstand 17 ist für jede Durchstichöffnung 8 ein die Durchstichöffnung 8 umschließender und berandender Bereich von dem Boden 3 ausgebildet, welcher das Dichtelement 7 in Gebrauchsstellung in der Aufnahme 12 stirnseitig nach außen begrenzt, so dass es nicht herausfallen oder sich nach außen wölben kann.The holding element 11 holds a minimum distance 17 from the puncture openings 8. Since the holding element 11 extends around the two puncture openings 8 like a spectacle, the distance of the holding element 11 from the puncture openings 8 in the area between the puncture openings 8 is greater than the minimum distance 17. This minimum distance 17 for each puncture opening 8 surrounds the puncture opening 8 and covers it Area formed by the bottom 3, which is the Sealing element 7 in the position of use in the receptacle 12 frontally limited to the outside, so that it does not fall out or can bulge outward.

Die Kontur, die das Halteelement 11 beschreibt, ist passend zu den Abmessungen des Dichtelements 7 gewählt.The contour which describes the holding element 11 is chosen to match the dimensions of the sealing element 7.

Das eingesetzte oder eingespritzte Dichtelement 7 kommt somit entlang seines gesamten Umfangs 9 mit dem Halteelement 11 in Berührkontakt. Das Halteelement 11 greift somit an diesen Berührstellen an dem Dichtelement 7 an und hält dieses.The inserted or injected sealing element 7 thus comes along its entire circumference 9 with the holding element 11 in touching contact. The holding element 11 thus acts on these contact points on the sealing element 7 and holds this.

Das Halteelement 11 ist als von dem Boden 3 abstehende Wandung mit dem Verschlusskörper 2 einstückig ausgebildet.The holding member 11 is integrally formed as protruding from the bottom wall 3 with the closure body 2.

Das Halteelement 11 ist von der Wand 5 entlang der durch das Halteelement 11 beschriebenen Kontur beabstandet und bildet somit mit der Wand 5 einen Zwischenraum 16. Halteelement 11 und Wand 5 schließen somit den Zwischenraum 16 ein. Dieser Zwischenraum 16 dient zum Ausgleich der Verformungskräfte in dem Verschlusskörper 2, wodurch die resultierende Verformung nicht auf die Gestalt des Halteelements 11 einwirkt. Der Zwischenraum 16 erstreckt sich über die gesamte Länge der durch das Halteelement 11 beschriebenen Kontur.The holding element 11 is spaced from the wall 5 along the contour described by the holding element 11 and thus forms a gap 16 with the wall 5. Holding element 11 and wall 5 thus close the intermediate space 16. This gap 16 serves to compensate for the deformation forces in the closure body 2, whereby the resulting deformation does not act on the shape of the holding element 11. The gap 16 extends over the entire length of the contour described by the holding member 11.

Durch das Halteelement 11 ist in dem Bereich der Aufnahme 12, der zwischen den Durchstichöffnungen 8 angeordnet ist, eine Verengung 14 ausgebildet. Diese Verengung 14 bewirkt, dass auf das Dichtelement 7 im Bereich der Durchstichöffnungen 8 über eine Vorspannung eine Kraftkomponente eingebracht werden kann, die im Wesentlichen parallel zu der Verbindungslinie der Mittelpunkte der Durchstichöffnungen 8 verläuft oder mit dieser Linie einen spitzen Winkel, vorzugsweise von weniger als 45°, einschließt.By the holding element 11, a constriction 14 is formed in the region of the receptacle 12 which is arranged between the puncture openings 8. This constriction 14 has the effect that a force component, which runs essentially parallel to the connecting line of the centers of the puncture openings 8 or with this line at an acute angle, preferably of less than 45, can be introduced to the sealing element 7 in the region of the puncture openings 8 via a pretension °, includes.

Das Dichtelement 7 ist in der Aufnahme 12 mit dem Verschlusskörper 2 kraftschlüssig verbunden, da aufgrund der Vorspannung des Dichtelements 7 die Haftreibung zwischen dem Umfang 9 des Dichtelements und dem Halteelement 11 erhöht ist.The sealing element 7 is frictionally connected in the receptacle 12 with the closure body 2, since due to the bias of the sealing element 7, the static friction between the periphery 9 of the sealing element and the holding member 11 is increased.

Figur 9 zeigt ein weiteres erfindungsgemäßes Ausführungsbeispiel einer Verschlusskappe 2. Der Verschlusskörper 2 gemäß Figur 9 unterscheidet sich von dem Verschlusskörper 2 gemäß Figur 8 dadurch, dass das Halteelement 11 aus mehreren separaten Segmenten 15 gebildet ist, welche gemeinsam eine Kontur beschreiben, welche die beiden Durchstichöffnungen 8 umläuft. FIG. 9 shows a further inventive embodiment of a closure cap 2. The closure body 2 according to Figure 9 differs from the closure body 2 according to FIG. 8 in that the holding element 11 is formed from a plurality of separate segments 15, which jointly describe a contour which surrounds the two puncture openings 8.

Wird in die durch das Halteelement 11 und den Boden 3 gebildete Aufnahme 12 ein vorgefertigtes Dichtelement 7 eingesetzt, so greifen die einzelnen Segmente 15 des Halteelements 11 jeweils an einem Abschnitt des Umfangs 9 des Dichtelements 7 an. Hierzu sind die Segmente 15 in ihrer Form jeweils an einen Abschnitt des Umfangs 9 des Dichtelements 7 angepasst.If a prefabricated sealing element 7 is inserted into the receptacle 12 formed by the retaining element 11 and the bottom 3, then the individual segments 15 of the retaining element 11 engage in each case against a section of the circumference 9 of the sealing element 7. For this purpose, the segments 15 are adapted in their shape in each case to a portion of the circumference 9 of the sealing element 7.

Die von dem Halteelement 11 beschriebene Kontur, welche die Durchstichöffnungen 8 gemeinsam umläuft, ist identisch mit der Kontur des Halteelements 11 gemäß Figur 8. Somit bildet das Halteelement 11 ebenfalls eine Verengung 14 im Bereich der Aufnahme 12 zwischen den Durchstichöffnungen 8 zu dem zuvor beschrieben Zweck. Auch bei diesem Ausführungsbeispiel halten die Kontur und somit die Segmente 15 einen Mindestabstand 17 zu den Durchstichöffnungen 8 ein, der größer ist Null. Durch diesen Mindestabstand 17 ist für jede Durchstichöffnung 8 ein die Durchstichöffnung 8 umschließender und berandender Bereich von dem Boden 3 ausgebildet, welcher das Dichtelement 7 in Gebrauchsstellung in der Aufnahme 12 stirnseitig nach außen begrenzt, so dass es nicht herausfallen oder sich nach außen wölben kann.The contour described by the holding element 11, which surrounds the puncture openings 8 together, is identical to the contour of the holding element 11 according to FIG FIG. 8 , Thus, the holding member 11 also forms a constriction 14 in the region of the receptacle 12 between the puncture openings 8 for the purpose described above. Also in this embodiment, the contour and thus the segments 15 maintain a minimum distance 17 to the puncture openings 8, which is greater than zero. By this minimum distance 17, a puncture opening 8 enclosing and bounding area of the bottom 3 is formed for each puncture opening 8, which limits the sealing element 7 in the position of use in the receptacle 12 frontally to the outside, so that it can not fall out or bulge outward.

Auch bei dem Ausführungsbeispiel gemäß Figur 9 ist das Halteelement 11 von der Wand 5 des topfförmigen Verschlusskörpers 2 beabstandet angeordnet, wodurch zwischen den Segmenten 15 und der Wand 5 jeweils Zwischenräume 16 gebildet werden. Durch die Beabstandung sind die Segmente 15 von Bewegungen der Wand 5, beispielsweise thermischen Verformungen, entkoppelt, und Verformungskräfte in dem Verschlusskörper 2 werden im Wesentlichen nicht auf das Halteelement 11 übertragen und führen daher im Wesentlichen nicht zu einer Gestaltsänderung der Aufnahme 12. Somit ist das Dichtelement 7 auch bei diesem Ausführungsbeispiel selbst dann sicher an dem Verschlusskörper 2 gehalten und erhält selbst dann seine Vorspannung, wenn sich der übrige Verschlusskörper 2 verformt.Also in the embodiment according to FIG. 9 the holding element 11 is spaced from the wall 5 of the cup-shaped closure body 2, whereby between the segments 15 and the wall 5 each intermediate spaces 16 are formed. As a result of the spacing, the segments 15 are decoupled from movements of the wall 5, for example thermal deformations, and deformation forces in the closure body 2 are essentially not transmitted to the holding element 11 and therefore do not substantially change the shape of the receptacle 12 Sealing element 7 even in this embodiment, even then held securely on the closure body 2 and receives even then its bias when the rest of the closure body 2 deforms.

Durch die Beabstandung des Halteelements 11 von der Wand 5 ist das Halteelement 11 unabhängig von der Wand 5 ausgebildet.Due to the spacing of the holding element 11 from the wall 5, the holding element 11 is formed independently of the wall 5.

Wird das Dichtelement 7 in die Aufnahme 12 eingespritzt, so gelangt Material des Dichtelements 7 durch die Lücken zwischen den Segmenten 15 auch in den Bereich zwischen dem Halteelement 11 und der Wand 5. In diesem Fall durchsetzen somit die Segmente 15 des Halteelements 11 das Dichtelement 7.If the sealing element 7 is injected into the receptacle 12, material of the sealing element 7 also passes through the gaps between the segments 15 into the area between the holding element 11 and the wall 5. In this case, the segments 15 of the holding element 11 penetrate the sealing element 7 ,

Das Bestehen eines Kontaktes zwischen Dichtelement 7 und der Wand 5 ist aber für den Halt des Dichtelements 7 in der Aufnahme 12 nicht erforderlich, da die Haltekräfte und die für das Aufbringen einer Vorspannung erforderliche Kräfte durch die Segmente 15 des Halteelements 11 aufgebracht werden. Ein derartiger Kontakt kann also bei unvermeidlichen thermischen Verformungen des Verschlusskörpers 2 verloren gehen, ohne das die Befestigung des Dichtelements 7 an dem Boden 3 leidet.However, the existence of a contact between sealing element 7 and the wall 5 is not required for the maintenance of the sealing element 7 in the receptacle 12, since the holding forces and the forces required for the application of a bias forces are applied by the segments 15 of the support member 11. Such a contact can therefore be lost in case of unavoidable thermal deformation of the closure body 2, without the attachment of the sealing element 7 suffers from the bottom 3.

Bei dem Verschluss 2 für ein insbesondere steriles Medikamentenbehältnis weist ein Verschlusskörper 2, welcher aus einem nicht-elastischen Material vorgefertigt ist, eine Topfform mit einem Boden 3 und einer Wand 4, 5 auf. In den Boden 3 der Topfform des Verschlusskörpers 2 ist wenigstens eine Durchstichöffnung 8 eingebracht, die zur Zugabe beziehungsweise Entnahme von flüssigen Medikamenten vorgesehen ist. Diese Durchstichöffnung 8 ist durch ein Dichtelement 7 abgedichtet. Das Dichtelement 7 ist in einer Aufnahme 12 gehalten, die durch den Boden 3 und ein von diesem Boden 3 in Gebrauchsstellung des Verschlusses 1 nach innen abstehendes Halteelement 11 gebildet ist.In the closure 2 for a particularly sterile medicament container, a closure body 2, which is prefabricated from a non-elastic material, a pot shape with a bottom 3 and a wall 4, 5 on. In the bottom 3 of the cup shape of the closure body 2 at least one puncture opening 8 is introduced, which is provided for the addition or removal of liquid drugs. This puncture opening 8 is sealed by a sealing element 7. The sealing element 7 is held in a receptacle 12, which is formed by the bottom 3 and one of this bottom 3 in the position of use of the closure 1 inwardly projecting retaining element 11.

Claims (19)

  1. Closure for a preferably sterile container for pharmaceuticals, said closure (1) being thermally deformable by heating for the connection with the container for pharmaceuticals, having a prefabricated closure body (2) which is pot-shaped having a bottom (3) and a wall (5) and which has at least one puncture opening (8) in the bottom (3) of its pot shape, wherein an elastically soft seal element (7) is located on said closure body (2) in the region of the bottom (3) of its pot shape in such a manner that the at least one puncture opening (8) is closed by the seal element (7) and a part of the seal element (7) is, in the use position of the closure (1), accessible from outside, characterized in that the closure body (2) has a retaining element (11) which is independent of the wall (5), said retaining element (11) protruding inwardly from the bottom (3) of the pot-shaped closure body (2) in the use position of the closure (1), and wherein a mounting (12) for the seal element (7) is formed by the retaining element (11) and the seal element (7) is located in the mounting (12), and that the seal element (7) is prefabricated, inserted into the mounting (12) and held there under pretension, and that the seal element (7) is integrally bonded to the closure body (2).
  2. Closure according to Claim 1, characterized in that the retaining element (11) is spaced from the wall (5) of the pot shape of the closure body (2) and forms at least sectionally an intermediate space (16) with said wall (5).
  3. Closure according to Claim 1 or 2, characterized in that the retaining element (11) forms a contour which encircles the at least one puncture opening (8) along the bottom (3).
  4. Closure according to one of Claims 1 to 3, characterized in that the intermediate space (16), which is formed by the retaining element (11) and the wall (5) of the pot shape of the closure (2), extends along the entire length of the contour.
  5. Closure according to one of Claims 1 to 4, characterized in that the retaining element (11) at least sectionally engages, along the contour, on a circumference (9) of the seal element (7).
  6. Closure according to one of Claims 1 to 5, characterized in that the retaining element (11) has ribs which engage on the inserted seal element (7) and which are in each case oriented transversely to the direction of extent of the circumference (9) of the seal element (7).
  7. Closure according to one of Claims 1 to 6, characterized in that the retaining element (11) is formed as a wall.
  8. Closure according to one of Claims 1 to 7, characterized in that the retaining element (11) has segments (15) which in each case are adapted to a section of the circumference (9) of the seal element (7).
  9. Closure according to one of Claims 1 to 8, characterized in that the retaining element (11) engages on the seal element (7) along the entire circumference (9) of the seal element (7).
  10. Closure according to one of Claims 1 to 9, characterized in that the retaining element (11) is formed integrally with the closure body (2).
  11. Closure according to one of Claims 1 to 10, characterized in that the seal element (7) is made from rubber material or from TPE material.
  12. Closure according to one of Claims 1 to 11, characterized in that the closure body (2) has, in the bottom (3) of its pot shape, at least two puncture openings (8) which are closed by the seal element (7) or in each case by one seal element (7), wherein in each case a part of one or of the seal element (7) is accessible through each puncture opening (8) in the use position of the closure (1).
  13. Closure according to Claim 12, characterized in that the retaining element (11) forms a contour which collectively encircles the at least two puncture openings (8).
  14. Closure according to one of Claims 12 or 13, characterized in that the retaining element (11) forms a restriction (14) in the mounting (12) for the seal element (7) in a region between the at least two puncture openings (8).
  15. Closure according to one of Claims 12 to 14, characterized in that a separate mounting (12) for a seal element (7) is formed on each puncture opening (8) of the closure body (2) by the retaining element (11).
  16. Closure according to one of Claims 1 to 15, characterized in that the bottom (3) of the pot shape of the closure (1) externally covers a part of the seal element (7) in the use position of the closure (1).
  17. Closure according to one of Claims 1 to 16, characterized in that the seal element (7) is delimited at the face side by the bottom (3) in a region (17) which is adjacent to the at least one puncture opening (8), said region (17) preferably enclosing or bordering the puncture opening (8).
  18. Closure according to one of Claims 1 to 17, characterized in that the seal element (7) is located spaced axially from the wall (5).
  19. Infusion container, characterized in that the closure of the infusion container is formed according to one of Claims 1 to 18.
EP09771718.5A 2008-12-09 2009-12-04 Closure for a container for pharmaceuticals Active EP2376341B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102008060995A DE102008060995A1 (en) 2008-12-09 2008-12-09 Closure for a medicine container
PCT/EP2009/008677 WO2010066382A1 (en) 2008-12-09 2009-12-04 Closure for a container for pharmaceuticals

Publications (2)

Publication Number Publication Date
EP2376341A1 EP2376341A1 (en) 2011-10-19
EP2376341B1 true EP2376341B1 (en) 2013-07-31

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Application Number Title Priority Date Filing Date
EP09771718.5A Active EP2376341B1 (en) 2008-12-09 2009-12-04 Closure for a container for pharmaceuticals

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US (1) US8616401B2 (en)
EP (1) EP2376341B1 (en)
CN (2) CN102256881B (en)
BR (1) BRPI0923234B1 (en)
DE (1) DE102008060995A1 (en)
ES (1) ES2433219T3 (en)
WO (1) WO2010066382A1 (en)

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CN102256881A (en) 2011-11-23
CN102256881B (en) 2014-04-02
US20110240642A1 (en) 2011-10-06
WO2010066382A1 (en) 2010-06-17
CN104015995A (en) 2014-09-03
CN104015995B (en) 2017-07-07
BRPI0923234B1 (en) 2019-05-14
DE102008060995A1 (en) 2010-06-10
ES2433219T3 (en) 2013-12-10
EP2376341A1 (en) 2011-10-19
BRPI0923234A2 (en) 2016-01-26
US8616401B2 (en) 2013-12-31

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