EP1802535B1 - Closing cap for containers filled with medical liquids - Google Patents

Closing cap for containers filled with medical liquids Download PDF

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Publication number
EP1802535B1
EP1802535B1 EP05770389A EP05770389A EP1802535B1 EP 1802535 B1 EP1802535 B1 EP 1802535B1 EP 05770389 A EP05770389 A EP 05770389A EP 05770389 A EP05770389 A EP 05770389A EP 1802535 B1 EP1802535 B1 EP 1802535B1
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EP
European Patent Office
Prior art keywords
membrane
closure cap
cap according
removal
cap
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EP05770389A
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German (de)
French (fr)
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EP1802535A1 (en
Inventor
Torsten Brandenburger
Ismael Rahimy
Gerald Wegner
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Fresenius Kabi Deutschland GmbH
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Fresenius Kabi Deutschland GmbH
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Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Priority to PL05770389T priority Critical patent/PL1802535T3/en
Publication of EP1802535A1 publication Critical patent/EP1802535A1/en
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS 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
    • B65D51/00Closures not otherwise provided for
    • B65D51/002Closures 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 cap for a container which is filled with a medical fluid, in particular for infusion or transfusion, in particular a filled with a liquid for parenteral nutrition bottle-shaped container. Moreover, the invention relates to a container for a medicinal liquid for infusion or transfusion, in particular a bottle-shaped container to be filled with a liquid for parenteral nutrition, which has such a closure cap.
  • the containers include on the one hand the known bags made of multilayer films, which are characterized by transparency, flexibility and sealability, on the other hand, the known bottles, which have different shapes.
  • the bags and bottles differ in the design of the approaches to the removal and supply of medical fluids, which are also referred to as a port.
  • the DE 102 23 560 A1 describes a bag with a port system comprising a withdrawal and injection point.
  • the port system has two separate connectors, one of which serves to remove the liquid and the other to inject an additive.
  • a so-called spike is generally used, which has a relatively large diameter, while for the injection of the additive, a cannula is used, which has a relatively small diameter.
  • different requirements are placed on the training of the collection and injection site.
  • a cap for a medicine bottle which has a sampling and injection point.
  • a common membrane made of an elastic material which is pierceable with a piercing (spike) of an infusion device for removing the drug and a cannula of a syringe for injecting an additive.
  • the membrane also called septum, is firmly welded to the cap.
  • a closure for a medicine bottle is also from the EP 0 364 783 B1 known. This closure is also characterized by a common septum for the port for removing the drug and injecting the additive.
  • the membranes used in medical technology must meet high requirements.
  • the membranes should on the one hand be pierceable with little effort and on the other hand safely seal the container.
  • the membrane should be sealed to seal the injection site after puncturing and removal of the cannula.
  • the membrane of the sampling point should also hold the piercing in tensile stress, so that the piercing part can not slide out of the puncture site.
  • the two membranes are identical.
  • the EP 0 495 330 A1 describes a device for providing access for a flexible container.
  • the known device has both a sampling point and an injection point.
  • the extraction and injection point are closed by membranes, which are designed differently.
  • the membrane of the sampling point is formed as a flat disc, which is widened at its edge, while the membrane of the injection point is curved on the top and bottom outward.
  • the membrane of the injection site is a self-sealing membrane.
  • the disadvantage is that the membrane of the sampling point is not self-sealing.
  • the object of the invention is to provide a closure cap for containers filled with medicinal liquids, in particular liquids for infusion or transfusion, with a withdrawal and injection site, which permits safe handling when the medical liquid is withdrawn and the additive is injected.
  • the removal and injection point are formed as separate accesses with different openings which are each closed by a pierceable self-sealing membrane.
  • the cap does not have a common membrane for both approaches, but two membranes that are designed differently. In this context, under different training, for example, different shapes or materials to understand.
  • the key advantage of the closure cap according to the invention is that the use of separate membranes for the extraction and injection point allows optimal adaptation to the different requirements that are placed on these approaches. Since the port system has membranes of different design, the extraction and injection point to the specific requirements when removing a liquid by means of a spiked part (spike), which has a relatively large diameter, and be optimally adapted when injecting an additive by means of a cannula has a relatively small diameter.
  • a spiked part spike
  • the membrane of the sampling point is designed such that the port can be pierced with a piercing part (spike), wherein the spike is held in tensile stress and the sampling point is securely sealed, while the membrane of the injection site is such that the port is sealed after puncture and removal of the cannula.
  • a piercing part spike
  • both membranes are clamped in the cap.
  • the membranes can also be deformed elastically. Consequently, the mounting of the cap can be done simply by pressing the individual parts in a simple manner. But it is also possible that the membranes are welded to the cap and / or glued.
  • a further preferred embodiment provides that the openings for the membranes are recesses in the cover part of the cap, in which the membranes are suitably inserted.
  • the positive connection ensures that the membranes have a secure fit.
  • a holding plate is arranged on the inside of the cover part of the cap, with which the membranes are clamped.
  • the retaining plate preferably on the membranes under cross-approaches.
  • An alternative embodiment provides the membranes under cross-approaches, which are not provided on a support plate, but on the inside of the cover part.
  • the lugs are preferably integral with the cover part.
  • the assembly can be further simplified if the lugs are bendable parts. Then the membranes need only be used in the lid part and the approaches to be bent.
  • the lugs are designed as annular flanges that provide a secure fit.
  • the holding plate is latching or snapping inserted into the cap.
  • the membranes are inserted into the lid part and then the holding plate in the side part of the cap.
  • the retaining plate may also be integral with the side part, wherein the lid part is formed as a hinged by the side part cap body. The membranes are then inserted into the folded cap body and the cap body is then folded onto the holding plate, so that the membranes between the cap body and holding plate are jammed.
  • the cap body is preferably attached to the side part with a hinge.
  • hinges are known as so-called film hinges in plastics technology.
  • the first and / or second opening in the cap are preferably closed with a twist-off part, which forms a tamper-evident closure.
  • the handling is preferably improved in that the Abcomp compiler are designed as flat handle parts.
  • the Abcomp compiler expediently each have a mark, in particular a trained in the manner of an arrow recess. Since the arrows point in opposite directions, it can immediately be recognized that the respective port is a withdrawal or injection point.
  • the self-sealing membrane of the extraction point preferably has an outer annular portion, which is followed by a central annular portion with an upper and lower abutment surface which is clamped in the cap.
  • the middle annular section merges into an inner dish-shaped section, on the upper side of which a trough-shaped depression is formed.
  • the inner dish-shaped section preferably has a flat underside.
  • the membrane of the donor site is preferably weakened, so that it can be easily pierced with a spike.
  • the membrane is pre-slit crosswise. But it can also be slotted star-shaped or provided only with a simple slot.
  • the membrane of the injection site differs from the membrane of the sampling site by its cross section in the center.
  • the membrane of the injection site has a larger cross-section than the membrane of the extraction site, i. one membrane is thicker in the center than the other membrane.
  • the membrane of the injection point preferably has an outer annular portion.
  • the inner plate-shaped portion connects directly, with trough-shaped depressions are formed both on the upper and lower side of the inner plate-shaped portion.
  • the inventive bottle-shaped container for medical fluids may have different shapes. In addition to round shapes, oval or flattened shapes are also possible.
  • FIG. 1 shows a first embodiment of the closure cap according to the invention for bottle-shaped containers, in particular with a liquid for parenteral nutrition filled bottles.
  • the closure cap is an injection molded part, which is preferably made of polyolefins, in particular PP, PE, PET and blends.
  • the cap 1 has a round lid part 2, to which a cylindrical side part 3 is connected. At the bottom of the side part 3 is a flange 4 for attaching the cap to the head of a bottle.
  • the cover part 2 has a greater wall thickness than the side part 3.
  • the cap 1 has a port system 5 with a removal point 6 and an injection point 7.
  • the port system is described in detail below.
  • the cover part 2 of the cap 5 has two openings 8, 9 with preferably circular cross-section, which are arranged at a distance to each other.
  • a first self-sealing membrane 10 for the removal point 6 and in the second opening 9, a second self-sealing membrane 11 for the injection point.
  • Both membranes are designed differently. They consist of an elastic material, preferably of a synthetic rubber, preferably of polyisoprene.
  • the first membrane 10 for the withdrawal point 6 has an outer annular portion 10a, which is followed by a central annular portion 10b, which has a smaller diameter than the outer portion.
  • the middle annular portion 10b having upper and lower abutment surfaces is clamped.
  • the middle annular portion 10b merges into an inner dish-shaped portion 10c, on the upper side of which an upper trough-shaped depression 10d is formed.
  • the dish-shaped portion 10c has a flat bottom 10e.
  • the dish-shaped section is pre-slit in a crosswise or star-shaped manner, so that, although weakened, the elastic material is not severed.
  • the second diaphragm 11 for the injection point 7, which is thicker than the first diaphragm 10, has an outer annular portion 11 a with an upper and lower abutment surface, which is clamped in the cap.
  • an inner plate-shaped portion 11 b To the annular portion 11 a is followed directly by an inner plate-shaped portion 11 b, at the top and bottom of an upper or lower trough-shaped recess 11 c, 11 d are formed.
  • the trough-shaped depressions 11 c and 11 d of the second membrane 10 have a smaller depth than the trough-shaped depression 10 d of the first membrane 10.
  • the two membranes 10, 11 are clamped by means of a holding plate 13, which snaps into the side part 3 of the cap or latching is used.
  • the edge of the holding plate 13 is seated in an annular groove 14 which extends on the inside of the side part 3 below the lid part 2.
  • the cover part 2 of the cap 1 has a shape complementary to the membranes 10, 11, so that the membranes fit snugly in the cover part.
  • the membranes were supported with the upper abutment surfaces on the underside of the cover part 2.
  • the holding plate 13 has two openings 8 a and 9 a, which have the same or a larger diameter as the corresponding openings 8 and 9 of the cover part 2.
  • the openings 8a and 9a are surrounded by annular projections 15, 16, which bear against the lower abutment surfaces of the membranes 10, 11.
  • the membranes 10, 11 are inserted into the openings 8, 9 of the cover part 2 of the cap 1. Then, the holding plate 13 is inserted into the cap 1, so that the membranes 10, 11 are clamped between the cover part and the holding plate.
  • the removal point 6 and injection point 7 of the cap are each closed with a twist-off 17, 18, which forms a tamper-evident closure.
  • Both Abwindmaschine 17, 18 are formed as flat handle parts, which are each connected via a ring breaking zone 19, 20 to the cover part 2. These handles are easy to turn off by hand.
  • the handle portion 17 has a recess 21 formed in the manner of an arrow, which points upwards, while the handle portion 18 has a recess 22 formed in the manner of an arrow, which points downwards. This makes it clear that after turning off the grip part 17, the removal point 6 and after turning off the grip part 18, the injection point is exposed.
  • the grip part 17 of the removal point 6 is turned off and a puncturing part (not shown), for example the spike of a transfer device for enteral nutrient solutions, or an infusion device inserted into the opening 8 of the lid part 2.
  • a puncturing part for example the spike of a transfer device for enteral nutrient solutions, or an infusion device inserted into the opening 8 of the lid part 2.
  • the pre-slit membrane 10 is pierced, so that the access to the container is made.
  • the grip part 18 is broken off and the cannula of a syringe is pricked into the membrane 11 of the injection site 7.
  • FIG. 2 shows an alternative embodiment of the with reference to the FIG. 1 described embodiment.
  • the cap of FIG. 2 is different from the cap of FIG. 1 only in that the cover part 2 'designed as a hinged cap body and the holding plate 13' is integral with the cap. Otherwise, both caps have the same training. Therefore, the same reference numerals are used for the corresponding parts.
  • the cover part 2 'of the cap 1' of FIG. 2 is attached by means of a film hinge 30, which extends only over part of the circumference of the cap, at the edge of the side part 3.
  • the film hinge 30 is diametrically opposite a snap closure 31, which also extends only over part of the circumference of the cap.
  • the snap closure 31 is formed by a projecting lug 31 a at the edge of the lid part 2 'and an undercut groove 31 b at the edge of the side part 3.
  • the two membranes 10, 11 are inserted into the folded lid part 2 ', and the lid part 2' is folded onto the holding plate 13 ', wherein the projection 31a snaps into the groove 31b.
  • the membranes are clamped again between holding part and cover part.
  • FIGS. 3a and 3b show a further embodiment of the closure cap, which differs from those with reference to the Figures 1 and 2 described embodiments characterized differs in that a holding plate is not provided.
  • the corresponding parts are again denoted by the same reference numerals.
  • the lugs 15 ', 16' for clamping the membranes 10, 11 are annular sleeves on the underside of the cover part 2, whose diameter corresponds to the diameter of the openings 8, 9.
  • the sleeve-shaped projection 15 'of the removal point 6 has a greater length than the projection 16' of the injection point. 7
  • the membranes 10, 11 are first inserted into the openings 8, 9 ( FIG. 3a ). Then the lugs 15 ', 16' are bent so that they rest against the lower contact surfaces of the membranes, so that the membranes are clamped. In the membrane 11 of the injection point 7 it is sufficient to bend the projection 16 'by 90 °. The projection 15 'of the removal point 6, however, is crimped around the outer annular portion 10a of the membrane ( FIG. 3b ).
  • FIG. 4 shows the lower portion of the lid portion of the cap of another embodiment, which differs from the other embodiments in that in the region where the lugs 15 ', 16' are bent, an annular groove 31, 32 is provided. Since the approaches are weakened in this area, the bending of the same is simplified.
  • FIG. 5 shows a bottle-shaped container 33 which is closed with the cap 1.
  • the cap 1 is firmly welded to the head 34 of the bottle 34. Between the cap 1 and the bottle head 34 sits a rubber disc, not shown.
  • the container is filled with a liquid for a parenteral nutrition.
  • the container may also be filled with an infusion or transfusion solution.

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

Abstract

The invention relates to a closing cap for containers that are filled with medical liquids. The closing cap includes removal and injection sites. The removal site has a first opening for removing the medical liquid and is obturated by a first pierceable self-sealing membrane. The injection site includes a second opening for injecting an additive and is obturated by a second pierceable self-sealing membrane. The first and second membranes are configured differently.

Description

Die Erfindung bezieht sich auf eine Verschlusskappe für ein Behältnis, das mit einer medizinischen Flüssigkeit, insbesondere zur Infusion oder Transfusion befüllt ist, insbesondere ein mit einer Flüssigkeit zur parenteralen Ernährung befüllte flaschenförmiges Behältnis. Darüber hinaus betrifft die Erfindung ein Behältnis für eine medizinische Flüssigkeit zur Infusion oder Transfusion, insbesondere ein mit einer Flüssigkeit zur parenteralen Ernährung zu befüllendes flaschenförmiges Behältnis, das über eine derartige Verschlusskappe verfügt.The invention relates to a closure cap for a container which is filled with a medical fluid, in particular for infusion or transfusion, in particular a filled with a liquid for parenteral nutrition bottle-shaped container. Moreover, the invention relates to a container for a medicinal liquid for infusion or transfusion, in particular a bottle-shaped container to be filled with a liquid for parenteral nutrition, which has such a closure cap.

Es sind verschiedene Behältnisse für medizinische Flüssigkeiten bekannt. Zu den Behältnissen zählen zum Einen die bekannten Beutel aus Mehrschichtfolien, die sich durch Transparenz, Flexibilität und Siegelbarkeit auszeichnen, zum Anderen die bekannten Flaschen, die unterschiedliche Formen haben. Die Beutel und Flaschen unterscheiden sich in der Ausbildung der Zugänge zum Entnehmen und Zuführen der medizinischen Flüssigkeiten, die auch als Port bezeichnet werden.Various containers for medical fluids are known. The containers include on the one hand the known bags made of multilayer films, which are characterized by transparency, flexibility and sealability, on the other hand, the known bottles, which have different shapes. The bags and bottles differ in the design of the approaches to the removal and supply of medical fluids, which are also referred to as a port.

Die DE 102 23 560 A1 beschreibt einen Beutel mit einem Port-System, das eine Entnahme- und Zuspritzstelle umfasst. Das Port-System verfügt über zwei separate Konnektoren, von denen der eine der Entnahme der Flüssigkeit und der andere dem Zuspritzen eines Additivs dient. Zum Entnehmen der Flüssigkeit findet im Allgemeinen ein sogenannter Spike Verwendung, der einen relativ großen Durchmesser hat, während zum Zuspritzen des Additivs eine Kanüle benutzt wird, die einen relativ kleinen Durchmesser hat. Insofern werden an die Ausbildung der Entnahme- und Zuspritzstelle unterschiedliche Anforderungen gestellt.The DE 102 23 560 A1 describes a bag with a port system comprising a withdrawal and injection point. The port system has two separate connectors, one of which serves to remove the liquid and the other to inject an additive. To remove the liquid, a so-called spike is generally used, which has a relatively large diameter, while for the injection of the additive, a cannula is used, which has a relatively small diameter. In this respect, different requirements are placed on the training of the collection and injection site.

Die bekannten Flaschen, die eine Alternative zu den häufig verwendeten Beuteln darstellen, werden mit einer Kappe verschlossen. Derartige Verschlusskappen sind auch als sogenannte Eurokappen bekannt, die in der DIN 58374 genormt sind.The known bottles, which are an alternative to the commonly used bags, are capped. Such caps are also known as so-called Euro caps, which are standardized in DIN 58374.

Aus der WO 02/098748 A1 ist eine Verschlusskappe für eine Medikamentenflasche bekannt, die über eine Entnahme- und Zuspritzstelle verfügt. Zur Abdichtung der Entnahme- und Zuspritzstelle dient eine gemeinsame Membran aus einem elastischen Material, die mit einem Einstechteil (Spike) eines Infusionsgeräts zum Entnehmen des Medikaments und einer Kanüle einer Spritze zum Injizieren eines Additivs durchstechbar ist. Die Membran, die auch als Septum bezeichnet wird, ist mit der Kappe fest verschweißt.From the WO 02/098748 A1 is a cap for a medicine bottle is known, which has a sampling and injection point. To seal the withdrawal and injection point is a common membrane made of an elastic material which is pierceable with a piercing (spike) of an infusion device for removing the drug and a cannula of a syringe for injecting an additive. The membrane, also called septum, is firmly welded to the cap.

Ein Verschluss für eine Medikamentenflasche ist auch aus der EP 0 364 783 B1 bekannt. Auch dieser Verschluss zeichnet sich durch ein gemeinsames Septum für den Port zum Entnehmen des Medikaments und Zuspritzen des Additivs aus.A closure for a medicine bottle is also from the EP 0 364 783 B1 known. This closure is also characterized by a common septum for the port for removing the drug and injecting the additive.

Die in der Medizintechnik verwendeten Membranen müssen hohen Anforderungen genügen. Die Membranen sollten einerseits mit geringem Kraftaufwand durchstechbar sein und andererseits das Behältnis sicher abdichten. So sollte die Membran zur Abdichtung der Zuspritzstelle nach der Punktierung und der Entfernung der Kanüle dicht sein. Die Membran der Entnahmestelle sollte zudem das Einstechteil bei Zugbeanspruchung festhalten, so dass das Einstechteil nicht aus der Einstechstelle herausgleiten kann.The membranes used in medical technology must meet high requirements. The membranes should on the one hand be pierceable with little effort and on the other hand safely seal the container. Thus, the membrane should be sealed to seal the injection site after puncturing and removal of the cannula. The membrane of the sampling point should also hold the piercing in tensile stress, so that the piercing part can not slide out of the puncture site.

Ein Medikamentenbehälter gemäß dem Oberbegriff des Anspruchs 1 mit einer topfförmigen Kappe, in die zwei Membranen eingesetzt sind, ist aus der EP 1 010 635 B1 bekannt. Die beiden Membranen sind aber identisch ausgebildet.A medicament container according to the preamble of claim 1 with a cup-shaped cap, are inserted into the two membranes, is from the EP 1 010 635 B1 known. The two membranes are identical.

Die EP 0 495 330 A1 beschreibt eine Vorrichtung zur Schaffung eines Zugangs für einen flexiblen Behälter. Die bekannte Vorrichtung verfügt sowohl über eine Entnahmestelle als auch eine Zuspritzstelle. Die Entnahme- und Zuspritzstelle werden von Membranen verschlossen, die unterschiedlich ausgebildet sind. Die Membran der Entnahmestelle ist als flache Scheibe ausgebildet, die an ihrem Rand wulstartig erweitert ist, während die Membran der Zuspritzstelle an der Ober- und Unterseite nach außen gewölbt ist.The EP 0 495 330 A1 describes a device for providing access for a flexible container. The known device has both a sampling point and an injection point. The extraction and injection point are closed by membranes, which are designed differently. The membrane of the sampling point is formed as a flat disc, which is widened at its edge, while the membrane of the injection point is curved on the top and bottom outward.

Die Membran der Zuspritzstelle ist eine selbstabdichtende Membran. Nachteilig ist, dass die Membran der Entnahmestelle nicht selbstabdichtend ist.The membrane of the injection site is a self-sealing membrane. The disadvantage is that the membrane of the sampling point is not self-sealing.

Der Erfindung liegt die Aufgabe zu Grunde, eine Verschlusskappe für mit medizinischen Flüssigkeiten, insbesondere Flüssigkeiten zur Infusion oder Transfusion befüllte Behältnisse mit einer Entnahme- und Zuspritzstelle bereitzustellen, die eine sichere Handhabung beim Entnehmen der medizinischen Flüssigkeit und dem Zuspritzen des Additivs erlaubt.The object of the invention is to provide a closure cap for containers filled with medicinal liquids, in particular liquids for infusion or transfusion, with a withdrawal and injection site, which permits safe handling when the medical liquid is withdrawn and the additive is injected.

Die Lösung dieser Aufgabe erfolgt erfindungsgemäß mit den Merkmalen des Patentanspruchs 1.The solution of this object is achieved according to the invention with the features of claim 1.

Darüber hinaus ist es eine Aufgabe der Erfindung, ein Behältnis für eine medizinische Flüssigkeit, insbesondere eine Flüssigkeit zur Infusion oder Transfusion, mit einer derartigen Verschlusskappe zu schaffen. Diese Aufgabe wird mit den Merkmalen des Anspruchs 26 gelöst.Moreover, it is an object of the invention to provide a container for a medical liquid, in particular a liquid for infusion or transfusion, with such a closure cap. This object is achieved with the features of claim 26.

Vorteilhafte Ausführungsformen der Erfindung sind Gegenstand der Unteransprüche.Advantageous embodiments of the invention are the subject of the dependent claims.

Bei der erfindungsgemäßen Verschlusskappe sind die Entnahme- und Zuspritzstelle als separate Zugänge mit unterschiedlichen Öffnungen ausgebildet, die jeweils von einer durchstechbaren selbstabdichtenden Membran verschlossen sind. Die Verschlusskappe verfügt also nicht über eine gemeinsame Membran für beide Zugänge, sondern über zwei Membranen, die unterschiedlich ausgebildet sind. In diesem Zusammenhang sind unter unterschiedlicher Ausbildung beispielsweise unterschiedliche Formen oder Materialien zu verstehen.In the closure cap according to the invention, the removal and injection point are formed as separate accesses with different openings which are each closed by a pierceable self-sealing membrane. The cap does not have a common membrane for both approaches, but two membranes that are designed differently. In this context, under different training, for example, different shapes or materials to understand.

Der entscheidende Vorteil der erfindungsgemäßen Verschlusskappe liegt darin, dass die Verwendung separater Membranen für die Entnahme- und Zuspritzstelle die optimale Anpassung an die unterschiedlichen Anforderungen erlaubt, die an diese Zugänge gestellt werden. Da das Portsystem über Membranen unterschiedlicher Ausbildung verfügt, sind die Entnahme- und Zuspritzstelle an die spezifischen Anforderungen beim Entnehmen einer Flüssigkeit mittels eines Einstechteils (Spike), der einen relativ großen Durchmesser aufweist, und beim Zuspritzen eines Additivs mittels einer Kanüle optimal angepasst werden, die einen relativ kleinen Durchmesser aufweist.The key advantage of the closure cap according to the invention is that the use of separate membranes for the extraction and injection point allows optimal adaptation to the different requirements that are placed on these approaches. Since the port system has membranes of different design, the extraction and injection point to the specific requirements when removing a liquid by means of a spiked part (spike), which has a relatively large diameter, and be optimally adapted when injecting an additive by means of a cannula has a relatively small diameter.

Die Membran der Entnahmestelle ist derart ausgebildet, dass der Port mit einem Einstechteil (Spike) durchstochen werden kann, wobei der Spike bei Zugbeanspruchung festgehalten und die Entnahmestelle sicher abgedichtet wird, während die Membran der Zuspritzstelle so beschaffen ist, dass der Port nach Punktierung und Entfernung der Kanüle dicht ist.The membrane of the sampling point is designed such that the port can be pierced with a piercing part (spike), wherein the spike is held in tensile stress and the sampling point is securely sealed, while the membrane of the injection site is such that the port is sealed after puncture and removal of the cannula.

Bei einer bevorzugten Ausführungsform der Verschlusskappe sind beide Membranen klemmend in der Kappe gehalten. Dabei können die Membranen auch elastisch verformt werden. Folglich kann die Montage der Verschlusskappe auf einfache Weise allein durch das Verpressen der einzelnen Teile erfolgen. Es ist aber auch möglich, dass die Membranen mit der Kappe verschweißt und/oder verklebt werden.In a preferred embodiment of the cap, both membranes are clamped in the cap. The membranes can also be deformed elastically. Consequently, the mounting of the cap can be done simply by pressing the individual parts in a simple manner. But it is also possible that the membranes are welded to the cap and / or glued.

Eine weitere bevorzugte Ausführungsform sieht vor, dass die Öffnungen für die Membranen Ausnehmungen in dem Deckelteil der Kappe sind, in denen die Membranen passend eingesetzt sind. Der Formschluss gewährleistet, dass die Membranen einen sicheren Halt haben.A further preferred embodiment provides that the openings for the membranes are recesses in the cover part of the cap, in which the membranes are suitably inserted. The positive connection ensures that the membranes have a secure fit.

Bei einer besonders bevorzugten Ausführungsform ist an der Innenseite des Deckelteils der Kappe eine Halteplatte angeordnet, mit der die Membranen verklemmt sind. Hierzu weist die Halteplatte vorzugsweise die Membranen untergreifende Ansätze auf.In a particularly preferred embodiment, a holding plate is arranged on the inside of the cover part of the cap, with which the membranes are clamped. For this purpose, the retaining plate preferably on the membranes under cross-approaches.

Eine alternative Ausführungsform sieht die Membranen untergreifende Ansätze vor, die nicht an einer Halteplatte, sondern an der Innenseite des Deckelteils vorgesehen sind. Die Ansätze sind vorzugsweise einstückig mit dem Deckelteil. Die Montage kann weiter vereinfacht werden, wenn die Ansätze biegbare Teile sind. Dann brauchen die Membranen nur in den Deckelteil eingesetzt und die Ansätze umgebogen zu werden. Vorzugsweise sind die Ansätze als ringförmige Bördelungen ausgebildet, die einen sicheren Halt bieten.An alternative embodiment provides the membranes under cross-approaches, which are not provided on a support plate, but on the inside of the cover part. The lugs are preferably integral with the cover part. The assembly can be further simplified if the lugs are bendable parts. Then the membranes need only be used in the lid part and the approaches to be bent. Preferably, the lugs are designed as annular flanges that provide a secure fit.

Bei einer weiteren besonders bevorzugten Ausführungsform ist die Halteplatte einrastend oder einschnappend in die Verschlusskappe eingesetzt. Zur Montage werden die Membranen in den Deckelteil und daraufhin die Halteplatte in den Seitenteil der Kappe eingesetzt.In a further particularly preferred embodiment, the holding plate is latching or snapping inserted into the cap. For assembly, the membranes are inserted into the lid part and then the holding plate in the side part of the cap.

Die Halteplatte kann aber auch mit dem Seitenteil einstückig sein, wobei der Deckelteil als von dem Seitenteil abklappbarer Kappenkörper ausgebildet ist. Die Membranen werden dann in den abgeklappten Kappenkörper eingesetzt und der Kappenkörper wird anschließend auf die Halteplatte geklappt, so dass die Membranen zwischen Kappenkörper und Halteplatte verklemmt sind.However, the retaining plate may also be integral with the side part, wherein the lid part is formed as a hinged by the side part cap body. The membranes are then inserted into the folded cap body and the cap body is then folded onto the holding plate, so that the membranes between the cap body and holding plate are jammed.

Der Kappenkörper ist vorzugsweise mit einem Scharnier an dem Seitenteil befestigt. Derartige Scharniere sind als sogenannte Filmscharniere in der Kunststofftechnik bekannt.The cap body is preferably attached to the side part with a hinge. Such hinges are known as so-called film hinges in plastics technology.

Die erste und/oder zweite Öffnung in der Kappe sind vorzugsweise mit einem Abdrehteil verschlossen, das gleichsam einen Originalitätsverschluss bildet. Die Handhabung wird vorzugsweise dadurch verbessert, dass die Abdrehteile als flache Griffteile ausgebildet sind. Die Abdrehteile weisen zweckmäßigerweise jeweils eine Kennzeichnung, insbesondere eine nach Art eines Pfeils ausgebildete Aussparung auf. Da die Pfeile in einander entgegengesetzte Richtungen zeigen, kann sofort erkannt werden, dass es sich bei dem jeweiligen Port um eine Entnahme- oder Zuspritzstelle handelt.The first and / or second opening in the cap are preferably closed with a twist-off part, which forms a tamper-evident closure. The handling is preferably improved in that the Abdrehteile are designed as flat handle parts. The Abdrehteile expediently each have a mark, in particular a trained in the manner of an arrow recess. Since the arrows point in opposite directions, it can immediately be recognized that the respective port is a withdrawal or injection point.

Die selbstabdichtende Membran der Entnahmestelle weist vorzugsweise einen äußeren ringförmigen Abschnitt auf, an den sich ein mittlerer ringförmiger Abschnitt mit einer oberen und unteren Anlagefläche anschließt, der in der Kappe klemmend gehalten ist. Der mittlere ringförmige Abschnitt geht in einen inneren tellerförmigen Abschnitt über, an dessen Oberseite eine muldenförmige Vertiefung ausgebildet ist. Dabei hat der innere tellerförmige Abschnitt vorzugsweise eine flache Unterseite. Die besondere Ausbildung der Membran stellt zum Einen sicher, dass der Spike beim Anstechen der Membran sicher geführt und gehalten wird und gewährleistet zum Anderen, dass die Membran nach dem Herausziehen des Spike auch bei relativ hohem Innendruck in dem Behältnis wieder sicher abdichtet. Es hat sich in Versuchen gezeigt, dass die besondere Ausbildung der Membran für den sofortigen Wiederverschluss ausschlaggebend ist, wobei mit zunehmendem Innendruck in der Verpackung die Abdichtung der Membran noch erhöht wird.The self-sealing membrane of the extraction point preferably has an outer annular portion, which is followed by a central annular portion with an upper and lower abutment surface which is clamped in the cap. The middle annular section merges into an inner dish-shaped section, on the upper side of which a trough-shaped depression is formed. In this case, the inner dish-shaped section preferably has a flat underside. The special design of the membrane ensures on the one hand that the spike is securely guided and held when piercing the membrane and on the other hand ensures that the membrane after pulling out of the spike seals securely even at relatively high internal pressure in the container again. It has been shown in experiments that the special design of the membrane for immediate reclosure is crucial, with increasing internal pressure in the package, the sealing of the membrane is still increased.

Die Membran der Entnahmestelle ist vorzugsweise geschwächt, so dass sie sich leicht mit einem Spike durchstechen lässt. Vorteilhafterweise ist die Membran kreuzweise vorgeschlitzt. Sie kann aber auch sternförmig geschlitzt oder nur mit einem einfachen Schlitz versehen sein.The membrane of the donor site is preferably weakened, so that it can be easily pierced with a spike. Advantageously, the membrane is pre-slit crosswise. But it can also be slotted star-shaped or provided only with a simple slot.

Die Membran der Zuspritzstelle unterscheidet sich von der Membran der Entnahmestelle durch ihren Querschnitt im Zentrum. Vorzugsweise weist die Membran der Zuspritzstelle einen größeren Querschnitt als die Membran der Entnahmestelle auf, d.h. die eine Membran ist im Zentrum dicker als die andere Membran.The membrane of the injection site differs from the membrane of the sampling site by its cross section in the center. Preferably, the membrane of the injection site has a larger cross-section than the membrane of the extraction site, i. one membrane is thicker in the center than the other membrane.

Auch die Membran der Zuspritzstelle weist vorzugsweise einen äußeren ringförmigen Abschnitt auf. An den äußeren ringförmigen Abschnitt schließt sich jedoch der innere tellerförmige Abschnitt direkt an, wobei sowohl an der Oberals auch Unterseite des inneren tellerförmigen Abschnitts muldenförmige Vertiefungen ausgebildet sind. Mit der besonderen Geometrie der Membran wird eine hohe Dichtigkeit erzielt.Also, the membrane of the injection point preferably has an outer annular portion. On the outer annular portion, however, the inner plate-shaped portion connects directly, with trough-shaped depressions are formed both on the upper and lower side of the inner plate-shaped portion. With the special geometry of the membrane, a high density is achieved.

Das erfindungsgemäße insbesondere flaschenförmige Behältnis für medizinische Flüssigkeiten kann unterschiedliche Formen haben. Neben runden Formen sind auch ovale oder abgeflachte Formen möglich.The inventive bottle-shaped container for medical fluids may have different shapes. In addition to round shapes, oval or flattened shapes are also possible.

Im Folgenden werden verschiedene Ausführungsbeispiele der Erfindung unter Bezugnahme auf die Zeichnungen näher erläutert.In the following, various embodiments of the invention will be explained in more detail with reference to the drawings.

Es zeigen:

Figur 1
ein erstes Ausführungsbeispiel der erfindungsgemäßen Verschlusskappe in geschnittener Darstellung,
Figur 2
eine alternative Ausführungsform der Kappe von Figur 1,
Figur 3a
ein weiteres Ausführungsbeispiel der erfindungsgemäßen Kappe vor der Befestigung der Membranen in dem Deckelteil,
Figur 3b
die Kappe von Figur 3a nach der Befestigung der Membranen,
Figur 4
ein weiteres Ausführungsbeispiel der Kappe und
Figur 5
das erfindungsgemäße kappenförmige Behältnis, das mit der erfindungsgemäßen Kappe verschlossen ist.
Show it:
FIG. 1
a first embodiment of the cap according to the invention in a sectional view,
FIG. 2
an alternative embodiment of the cap of FIG. 1 .
FIG. 3a
A further embodiment of the cap according to the invention before the attachment of the membranes in the lid part,
FIG. 3b
the cap of FIG. 3a after fixing the membranes,
FIG. 4
another embodiment of the cap and
FIG. 5
the cap-shaped container according to the invention, which is closed with the cap according to the invention.

Figur 1 zeigt ein erstes Ausführungsbeispiel der erfindungsgemäßen Verschlusskappe für flaschenförmige Behältnisse, insbesondere mit einer Flüssigkeit zur parenteralen Ernährung befüllte Flaschen. Die Verschlusskappe ist ein Spritzgussteil, das vorzugsweise aus Polyolefinen, insbesondere PP, PE, PET und Blends hergestellt ist. FIG. 1 shows a first embodiment of the closure cap according to the invention for bottle-shaped containers, in particular with a liquid for parenteral nutrition filled bottles. The closure cap is an injection molded part, which is preferably made of polyolefins, in particular PP, PE, PET and blends.

Die Verschlusskappe 1 weist einen runden Deckelteil 2 auf, an den sich ein zylindrischer Seitenteil 3 anschließt. Am unteren Rand des Seitenteils 3 befindet sich ein Flansch 4 zur Befestigung der Kappe am Kopf einer Flasche. Der Deckelteil 2 weist eine größere Wandstärke als der Seitenteil 3 auf.The cap 1 has a round lid part 2, to which a cylindrical side part 3 is connected. At the bottom of the side part 3 is a flange 4 for attaching the cap to the head of a bottle. The cover part 2 has a greater wall thickness than the side part 3.

Die Kappe 1 verfügt über ein Portsystem 5 mit einer Entnahmestelle 6 und einer Zuspritzstelle 7. Im Folgenden wird das Portsystem im Einzelnen beschrieben. Der Deckelteil 2 der Kappe 5 weist zwei Öffnungen 8, 9 mit vorzugsweise kreisförmigem Querschnitt auf, die im Abstand zueinander angeordnet sind. In der ersten Öffnung 8 sitzt eine erste selbstabdichtende Membran 10 für die Entnahmestelle 6 und in der zweiten Öffnung 9 eine zweite selbstabdichtende Membran 11 für die Zuspritzstelle. Beide Membranen sind unterschiedlich ausgebildet. Sie bestehen aus einem elestischen Material, vorzugsweise aus einem synthetischen Kautschuk, vorzugsweise aus Polyisopren.The cap 1 has a port system 5 with a removal point 6 and an injection point 7. The port system is described in detail below. The cover part 2 of the cap 5 has two openings 8, 9 with preferably circular cross-section, which are arranged at a distance to each other. In the first opening 8 sits a first self-sealing membrane 10 for the removal point 6 and in the second opening 9, a second self-sealing membrane 11 for the injection point. Both membranes are designed differently. They consist of an elastic material, preferably of a synthetic rubber, preferably of polyisoprene.

Die erste Membran 10 für die Entnahmestelle 6 weist einen äußeren ringförmigen Abschnitt 10a auf, an den sich ein mittlerer ringförmiger Abschnitt 10b anschließt, der einen geringeren Durchmesser als der äußere Abschnitt hat. In der Kappe ist der mittlere ringförmige Abschnitt 10b, der eine obere und untere Anlagefläche hat, klemmend gehalten. Der mittlere ringförmige Abschnitt 10b geht in einen inneren tellerförmigen Abschnitt 10c über, an dessen Oberseite eine obere muldenförmige Vertiefung 10d ausgebildet ist. Der tellerförmige Abschnitt 10c hat eine flache Unterseite 10e. Im Zentrum der muldenförmigen Vertiefung 10d ist der tellerförmige Abschnitt derart kreuzweise oder sternförmig vorgeschlitzt, so dass das elastische Material zwar geschwächt aber nicht durchtrennt ist.The first membrane 10 for the withdrawal point 6 has an outer annular portion 10a, which is followed by a central annular portion 10b, which has a smaller diameter than the outer portion. In the cap, the middle annular portion 10b having upper and lower abutment surfaces is clamped. The middle annular portion 10b merges into an inner dish-shaped portion 10c, on the upper side of which an upper trough-shaped depression 10d is formed. The dish-shaped portion 10c has a flat bottom 10e. In the center of the trough-shaped depression 10d, the dish-shaped section is pre-slit in a crosswise or star-shaped manner, so that, although weakened, the elastic material is not severed.

Die zweite Membran 11 für die Zuspritzstelle 7, die dicker als die erste Membran 10 ist, weist einen äußeren ringförmigen Abschnitt 11 a mit einer oberen und unteren Anlagefläche auf, der in der Kappe klemmend gehalten ist. An den ringförmigen Abschnitt 11 a schließt sich direkt ein innerer tellerförmiger Abschnitt 11 b an, an dessen Ober- und Unterseite eine obere bzw. untere muldenförmige Vertiefung 11 c, 11 d ausgebildet sind. Die muldenförmigen Vertiefungen 11c und 11d der zweiten Membran 10 haben eine geringere Tiefe als die muldenförmige Vertiefung 10d der ersten Membran 10.The second diaphragm 11 for the injection point 7, which is thicker than the first diaphragm 10, has an outer annular portion 11 a with an upper and lower abutment surface, which is clamped in the cap. To the annular portion 11 a is followed directly by an inner plate-shaped portion 11 b, at the top and bottom of an upper or lower trough-shaped recess 11 c, 11 d are formed. The trough-shaped depressions 11 c and 11 d of the second membrane 10 have a smaller depth than the trough-shaped depression 10 d of the first membrane 10.

Die beiden Membranen 10, 11 werden mittels einer Halteplatte 13 klemmend gehalten, die in den Seitenteil 3 der Kappe einschnappend oder einrastend eingesetzt ist. Der Rand der Halteplatte 13 sitzt in einer ringförmigen Nut 14, die an der Innenseite des Seitenteils 3 unterhalb des Deckelteils 2 verläuft.The two membranes 10, 11 are clamped by means of a holding plate 13, which snaps into the side part 3 of the cap or latching is used. The edge of the holding plate 13 is seated in an annular groove 14 which extends on the inside of the side part 3 below the lid part 2.

Im Bereich der Öffnungen 8, 9 weist der Deckelteil 2 der Kappe 1 eine den Membranen 10, 11 komplementäre Form auf, so dass die Membranen passend in dem Deckelteil sitzen. Dabei stützten sich die Membranen mit den oberen Anlageflächen an der Unterseite des Deckelteils 2 ab.In the region of the openings 8, 9, the cover part 2 of the cap 1 has a shape complementary to the membranes 10, 11, so that the membranes fit snugly in the cover part. The membranes were supported with the upper abutment surfaces on the underside of the cover part 2.

Die Halteplatte 13 weist zwei Öffnungen 8a und 9a auf, die den gleichen oder einen größeren Durchmesser wie die entsprechenden Öffnungen 8 und 9 des Deckelteils 2 haben. Die Öffnungen 8a und 9a werden von ringförmigen Ansätze 15, 16 umgeben, die an den unteren Anlageflächen der Membranen 10, 11 anliegen.The holding plate 13 has two openings 8 a and 9 a, which have the same or a larger diameter as the corresponding openings 8 and 9 of the cover part 2. The openings 8a and 9a are surrounded by annular projections 15, 16, which bear against the lower abutment surfaces of the membranes 10, 11.

Zur Montage werden die Membranen 10, 11 in die Öffnungen 8, 9 des Deckelteils 2 der Kappe 1 eingesetzt. Daraufhin wird die Halteplatte 13 in die Kappe 1 eingesetzt, so dass die Membranen 10, 11 zwischen Deckelteil und Halteplatte verklemmt sind.For mounting, the membranes 10, 11 are inserted into the openings 8, 9 of the cover part 2 of the cap 1. Then, the holding plate 13 is inserted into the cap 1, so that the membranes 10, 11 are clamped between the cover part and the holding plate.

Die Entnahmestelle 6 und Zuspritzstelle 7 der Kappe sind jeweils mit einem Abdrehteil 17, 18 verschlossen, das einen Originalitätsverschluss bildet. Beide Abdrehteile 17, 18 sind als flache Griffteile ausgebildet, die jeweils über eine Ringbruchzone 19, 20 an den Deckelteil 2 angeschlossen sind. Diese Griffteile lassen sich leicht mit der Hand abdrehen. Der Griffteil 17 weist eine nach Art eine Pfeils ausgebildete Aussparung 21 auf, die nach oben zeigt, während der Griffteil 18 eine nach Art eines Pfeils ausgebildete Aussparung 22 aufweist, die nach unten zeigt. Dadurch wird deutlich, dass nach Abdrehen des Griffteils 17 die Entnahmestelle 6 und nach Abdrehen des Griffteils 18 die Zuspritzstelle freiliegt.The removal point 6 and injection point 7 of the cap are each closed with a twist-off 17, 18, which forms a tamper-evident closure. Both Abdrehteile 17, 18 are formed as flat handle parts, which are each connected via a ring breaking zone 19, 20 to the cover part 2. These handles are easy to turn off by hand. The handle portion 17 has a recess 21 formed in the manner of an arrow, which points upwards, while the handle portion 18 has a recess 22 formed in the manner of an arrow, which points downwards. This makes it clear that after turning off the grip part 17, the removal point 6 and after turning off the grip part 18, the injection point is exposed.

Zum Entnehmen einer medizinischen Flüssigkeit wird der Griffteil 17 der Entnahmestelle 6 abgedreht und ein nicht dargestelltes Einstechteil, beispielsweise der Spike eines Überleitgerätes für enterale Nährlösungen oder eines Infusionsgerätes in die Öffnung 8 des Deckelteils 2 eingeführt. Dabei wird die vorgeschlitzte Membran 10 durchstochen, so dass der Zugang zu dem Behältnis hergestellt ist.To remove a medical fluid, the grip part 17 of the removal point 6 is turned off and a puncturing part (not shown), for example the spike of a transfer device for enteral nutrient solutions, or an infusion device inserted into the opening 8 of the lid part 2. In this case, the pre-slit membrane 10 is pierced, so that the access to the container is made.

Zum Zuspritzen eines Additivs wird der Griffteil 18 abgebrochen und die Kanüle einer Spritze in die Membran 11 der Zuspritzstelle 7 gestochen.To inject an additive, the grip part 18 is broken off and the cannula of a syringe is pricked into the membrane 11 of the injection site 7.

Figur 2 zeigt eine alternative Ausführungsform des unter Bezugnahme auf die Figur 1 beschriebenen Ausführungsbeispiels. Die Verschlusskappe von Figur 2 unterscheidet sich von der Kappe von Figur 1 nur dadurch, dass der Deckelteil 2' als abklappbarer Kappenkörper ausgebildet und die Halteplatte 13' mit der Kappe einstückig ist. Ansonsten haben beide Kappen die gleiche Ausbildung. Daher werden für die einander entsprechenden Teile auch die gleichen Bezugszeichen verwandt. FIG. 2 shows an alternative embodiment of the with reference to the FIG. 1 described embodiment. The cap of FIG. 2 is different from the cap of FIG. 1 only in that the cover part 2 'designed as a hinged cap body and the holding plate 13' is integral with the cap. Otherwise, both caps have the same training. Therefore, the same reference numerals are used for the corresponding parts.

Der Deckelteil 2' der Kappe 1' von Figur 2 ist mittels eines Filmscharniers 30, das sich nur über einen Teil des Umfangs der Kappe erstreckt, am Rand des Seitenteils 3 befestigt. Dem Filmscharnier 30 liegt diametral ein Schnappverschluss 31 gegenüber, der sich ebenfalls nur über einen Teil des Umfangs der Kappe erstreckt. Der Schnappverschluss 31 wird von einem vorspringenden Ansatz 31a am Rand des Deckelteils 2' und einer hinterschnittenen Nut 31b am Rand des Seitenteils 3 gebildet.The cover part 2 'of the cap 1' of FIG. 2 is attached by means of a film hinge 30, which extends only over part of the circumference of the cap, at the edge of the side part 3. The film hinge 30 is diametrically opposite a snap closure 31, which also extends only over part of the circumference of the cap. The snap closure 31 is formed by a projecting lug 31 a at the edge of the lid part 2 'and an undercut groove 31 b at the edge of the side part 3.

Zur Montage der Kappe werden die beiden Membranen 10, 11 in den abgeklappten Deckelteil 2' eingesetzt, und der Deckelteil 2' wird auf die Halteplatte 13' geklappt, wobei der Ansatz 31a in die Nut 31b einschnappt. Die Membranen sind wieder zwischen Halteteil und Deckelteil verklemmt.To mount the cap, the two membranes 10, 11 are inserted into the folded lid part 2 ', and the lid part 2' is folded onto the holding plate 13 ', wherein the projection 31a snaps into the groove 31b. The membranes are clamped again between holding part and cover part.

Die Figuren 3a und 3b zeigen ein weiteres Ausführungsbeispiel der Verschlusskappe, die sich von den unter Bezugnahme auf die Figuren 1 und 2 beschriebenen Ausführungsformen dadurch unterscheidet, dass eine Halteplatte nicht vorgesehen ist. Die einander entsprechenden Teile werden wieder mit den gleichen Bezugszeichen bezeichnet.The FIGS. 3a and 3b show a further embodiment of the closure cap, which differs from those with reference to the Figures 1 and 2 described embodiments characterized differs in that a holding plate is not provided. The corresponding parts are again denoted by the same reference numerals.

Die Ansätze 15', 16' zum Verklemmen der Membranen 10, 11 sind ringförmige Hülsen an der Unterseite des Deckelteils 2, deren Durchmesser dem Durchmesser der Öffnungen 8, 9 entspricht. Der hülsenförmige Ansatz 15' der Entnahmestelle 6 hat eine größere Länge als der Ansatz 16' der Zuspritzstelle 7.The lugs 15 ', 16' for clamping the membranes 10, 11 are annular sleeves on the underside of the cover part 2, whose diameter corresponds to the diameter of the openings 8, 9. The sleeve-shaped projection 15 'of the removal point 6 has a greater length than the projection 16' of the injection point. 7

Die Membranen 10, 11 werden zunächst in die Öffnungen 8, 9 eingesetzt (Figur 3a). Dann werden die Ansätze 15', 16' derart umgebogen, dass sie an den unteren Anlageflächen der Membranen anliegen, so dass die Membranen klemmend gehalten sind. Bei der Membran 11 der Zuspritzstelle 7 genügt es, den Ansatz 16' um 90° abzuwinkeln. Der Ansatz 15' der Entnahmestelle 6 hingegen wird um den äußeren ringförmigen Abschnitt 10a der Membran umgebördelt (Figur 3b).The membranes 10, 11 are first inserted into the openings 8, 9 ( FIG. 3a ). Then the lugs 15 ', 16' are bent so that they rest against the lower contact surfaces of the membranes, so that the membranes are clamped. In the membrane 11 of the injection point 7 it is sufficient to bend the projection 16 'by 90 °. The projection 15 'of the removal point 6, however, is crimped around the outer annular portion 10a of the membrane ( FIG. 3b ).

Figur 4 zeigt den unteren Abschnitt des Deckelteils der Kappe eines weiteren Ausführungsbeispiels, der sich von den anderen Ausführungsformen dadurch unterscheidet, dass in dem Bereich, an denen die Ansätze 15', 16' abgeknickt werden, eine ringförmige Nut 31, 32 vorgesehen ist. Da die Ansätze in diesem Bereich geschwächt sind, wird das Umbiegen derselben vereinfacht. FIG. 4 shows the lower portion of the lid portion of the cap of another embodiment, which differs from the other embodiments in that in the region where the lugs 15 ', 16' are bent, an annular groove 31, 32 is provided. Since the approaches are weakened in this area, the bending of the same is simplified.

Figur 5 zeigt ein flaschenförmiges Behältnis 33, das mit der Verschlusskappe 1 verschlossen ist. Die Verschlusskappe 1 wird mit dem Kopf 34 der Flasche 34 fest verschweißt. Zwischen Verschlusskappe 1 und Flaschenkopf 34 sitzt eine nicht dargestellte Gummischeibe. Das Behältnis ist mit einer Flüssigkeit für eine parenterale Ernährung befüllt. Das Behältnis kann aber auch mit einer Infusions- oder Transfusionslösung befüllt sein. FIG. 5 shows a bottle-shaped container 33 which is closed with the cap 1. The cap 1 is firmly welded to the head 34 of the bottle 34. Between the cap 1 and the bottle head 34 sits a rubber disc, not shown. The container is filled with a liquid for a parenteral nutrition. The container may also be filled with an infusion or transfusion solution.

Claims (27)

  1. A closure cap (1) for containers filled with medical liquids, in particular containers filled with liquids for infusion or transfusion, which comprises a removal and injection site (6, 7) for removing the medical liquid and injecting an additive, wherein the removal and injection sites (6, 7) are formed as separate accesses to a first opening (8) for removing the liquid, which is closed by a first pierceable self-sealing membrane (10), and to a second opening (9) for injecting the additive, which is closed by a second pierceable self-sealing membrane (11), characterised in that the first and second pierceable membranes are formed differently, and in that the first membrane (10) is formed as a self-sealing membrane, in such a way that the first membrane for removing the liquid can be pierced with a spike of a transfer device for enteral nutritive solutions or an infusion device and the spike can be held fast after the piercing for the secure sealing of the first membrane in the presence of tensile load, and the second membrane (11) is formed as a self-sealing membrane, in such a way that the second membrane can be pierced by a cannula of a syringe for the injection of an additive, the cannula having a smaller diameter than the spike.
  2. The closure cap according to claim 1, characterised in that the first and/or second membrane (10, 11) of the respective removal and injection site (6, 7) are held in a clamped manner.
  3. The closure cap according to claim 1 or 2, characterised in that the cap comprises a lid part (2) and a side part (3), the first and second opening (8, 9) being recesses in the lid part, in which the first and second membrane (10, 11) are inserted in a matching fashion.
  4. The closure cap according to claim 3, characterised in that there is arranged at the inside of the lid part (2) a retaining plate (13, 13'), with which the first and second membrane (10, 11) of the respective removal and injection site (6, 7) are clamped.
  5. The closure cap according to claim 4, characterised in that the retaining plate (13, 13') comprises shoulders (15, 16) engaging beneath the first and/or second membrane (10, 11) of the respective removal and injection site (6, 7).
  6. The closure cap according to claim 3, characterised in that shoulders (15', 16') engaging beneath the first and/or second membrane (10, 11) of the respective removal and injection site (6, 7) are arranged at the inside of the lid part (2).
  7. The closure cap according to claim 6, characterised in that the shoulders (15', 16') are in one piece with the lid part (2).
  8. The closure cap according to claim 6 or 7, characterised in that the shoulders (15', 16') are formed as an annular flange.
  9. The closure cap according to any one of claims 4 or 5, characterised in that the retaining plate (13) is inserted into the cap in a lock-in or snap-in manner.
  10. The closure cap according to any one of claims 4 or 5, characterised in that the retaining plate (13) is in one piece with the side part (3), the lid part (2) being formed as a cap body which can be folded down from the side part.
  11. The closure cap according to claim 10, characterised in that the lid part (2) is fixed with a hinge (30) to the side part (3).
  12. The closure cap according to any one of claims 1 to 11, characterised in that the first and/or second opening (8, 9) are each closed with a twist-off part (17, 18).
  13. The closure cap according to claim 12, characterised in that the twist-off parts (17, 18) are formed as flat grip parts.
  14. The closure cap according to claim 12 or 13, characterised in that the twist-off parts (17, 18) are marked differently.
  15. The closure cap according to claim 14, characterised in that the twist-off parts (17, 18) each comprise a recess (21, 22) formed in the manner of an arrow, the arrows pointing in directions opposite to one another.
  16. The closure cap according to any one of claims 1 to 15, characterised in that the first membrane (10) of the removal site (6) comprises a trough-shaped recess (10d) at the upper side.
  17. The closure cap according to claim 16, characterised in that the first membrane (10) comprises an outer annular portion (10a), which is followed by a middle annular portion (10b) with an upper and lower seating face, which is held in a clamped manner in the cap, the middle annular portion transforming into an inner plate-shaped portion (10c), in which the upper trough-shaped recess (10d) is formed.
  18. The closure cap according to claim 17, characterised in that the inner plate-shaped portion (10c) comprises a flat underside (10e).
  19. The closure cap according to claim 17 or 18, characterised in that the middle annular portion (10b) has a smaller cross-section than the outer annular portion (10a) of the first membrane (10).
  20. The closure cap according to any one of claims 1 to 19, characterised in that the first membrane (10) of the removal site (6) has a smaller cross-section in the centre than the second membrane of the injection site (7).
  21. The closure cap according to any one of claims 1 to 20, characterised in that the first membrane (10) of the removal site (6) is weakened, preferably pre-slit.
  22. The closure cap according to any one of claims 1 to 21, characterised in that the second membrane (11) of the injection site (7) comprises a trough-shaped recess (11c, 11d) at the upper side and the lower side.
  23. The closure cap according to claim 22, characterised in that the second membrane comprises an outer annular portion (11a) with an upper and lower seating face, which outer annular portion is held in a clamped manner in the cap and which is followed by an inner plate-shaped portion (116), in which the upper and a lower trough-shaped recess (11c, 11d) is formed.
  24. The closure cap according to any one of claims 1 to 23, characterised in that the first and/or second membrane of the respective removal and injection site (6, 7) is made from a synthetic rubber, preferably polyisoprene.
  25. The closure cap according to any one of claims 1 to 24, characterised in that the cap is an injection-moulded part, in particular made of polyolefin.
  26. A container for medical liquids, in particular liquids for infusion or transfusion, with a cap according to any one of claims 1 to 25.
  27. The container according to claim 26, characterised in that the container is a bottle-shaped container.
EP05770389A 2004-10-20 2005-08-12 Closing cap for containers filled with medical liquids Active EP1802535B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL05770389T PL1802535T3 (en) 2004-10-20 2005-08-12 Closing cap for containers filled with medical liquids

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102004051300A DE102004051300C5 (en) 2004-10-20 2004-10-20 Cap for containers filled with medical fluids
PCT/EP2005/008787 WO2006042579A1 (en) 2004-10-20 2005-08-12 Closing cap for containers filled with medical liquids

Publications (2)

Publication Number Publication Date
EP1802535A1 EP1802535A1 (en) 2007-07-04
EP1802535B1 true EP1802535B1 (en) 2009-11-18

Family

ID=35160519

Family Applications (1)

Application Number Title Priority Date Filing Date
EP05770389A Active EP1802535B1 (en) 2004-10-20 2005-08-12 Closing cap for containers filled with medical liquids

Country Status (17)

Country Link
US (1) US8211081B2 (en)
EP (1) EP1802535B1 (en)
JP (1) JP4903708B2 (en)
KR (1) KR101215752B1 (en)
CN (1) CN101044069B (en)
AT (1) ATE449012T1 (en)
AU (1) AU2005297511B2 (en)
BR (1) BRPI0517279B1 (en)
CA (1) CA2584384C (en)
DE (2) DE102004051300C5 (en)
DK (1) DK1802535T3 (en)
EA (1) EA009498B1 (en)
ES (1) ES2332417T3 (en)
MX (1) MX2007004706A (en)
PL (1) PL1802535T3 (en)
WO (1) WO2006042579A1 (en)
ZA (1) ZA200703192B (en)

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Also Published As

Publication number Publication date
US20090054865A1 (en) 2009-02-26
JP2008516707A (en) 2008-05-22
ZA200703192B (en) 2008-09-25
CN101044069B (en) 2010-08-25
KR101215752B1 (en) 2012-12-27
US8211081B2 (en) 2012-07-03
DK1802535T3 (en) 2010-01-25
ATE449012T1 (en) 2009-12-15
ES2332417T3 (en) 2010-02-04
DE502005008558D1 (en) 2009-12-31
JP4903708B2 (en) 2012-03-28
CN101044069A (en) 2007-09-26
WO2006042579A1 (en) 2006-04-27
EP1802535A1 (en) 2007-07-04
DE102004051300C5 (en) 2013-01-24
AU2005297511B2 (en) 2012-02-02
DE102004051300B3 (en) 2005-11-17
CA2584384C (en) 2017-04-11
KR20070083666A (en) 2007-08-24
CA2584384A1 (en) 2006-04-27
PL1802535T3 (en) 2010-04-30
EA009498B1 (en) 2008-02-28
BRPI0517279B1 (en) 2018-06-12
EA200700905A1 (en) 2007-10-26
BRPI0517279A (en) 2008-10-07
MX2007004706A (en) 2007-06-14
AU2005297511A1 (en) 2006-04-27

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