EP3519315A1 - Capuchon de fermeture pour un contenant destiné à contenir un liquide médical - Google Patents

Capuchon de fermeture pour un contenant destiné à contenir un liquide médical

Info

Publication number
EP3519315A1
EP3519315A1 EP17777874.3A EP17777874A EP3519315A1 EP 3519315 A1 EP3519315 A1 EP 3519315A1 EP 17777874 A EP17777874 A EP 17777874A EP 3519315 A1 EP3519315 A1 EP 3519315A1
Authority
EP
European Patent Office
Prior art keywords
sealing element
sealing
cap
connection device
outer side
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.)
Pending
Application number
EP17777874.3A
Other languages
German (de)
English (en)
Inventor
Torsten Brandenburger
Christian FRENSCH
Andreas Pfeffer
Alexander Degen
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.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of EP3519315A1 publication Critical patent/EP3519315A1/fr
Pending legal-status Critical Current

Links

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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps

Definitions

  • Cap for a container for receiving a medical
  • the invention relates to a closure cap for a container for receiving a medical fluid according to the preamble of claim 1.
  • Such a closure cap comprises a cap body which delimits an interior space and has at least one opening. At least one connecting device is arranged on the cap body, to which a conveying device for feeding a medical fluid into the container or for removing a medical fluid from the container can be connected.
  • the connection device has a sealing element arranged on the cap body, which is arranged for sealing closure at the opening.
  • a conveyor for connecting the conveyor can be attached.
  • Such a conveying device can be designed, for example, as an injection syringe, which can be attached to the sealing element with an injection cannula and introduced into a fitting direction in the sealing element, so that the sealing element is pierced by the injection cannula.
  • Such a syringe is used in particular for supplying a medical fluid into the container.
  • an infusion set may be used, for example, which is attached to the sealing element with a spike, which is also referred to as a spike, so that the sealing element is pierced by the spike and thus creates access to the receptacle becomes.
  • connection devices each having a sealing element are provided.
  • One of these connection devices is used for supplying a medical fluid into a container connected to the closure cap, for example a bottle, while the other connection device serves for removing a medical fluid from the container.
  • the content of this patent application is incorporated into the present application by reference in its entirety and in particular with reference to Figures 3.a and 3.b and the description thereof.
  • connection devices of which a first for supplying a medical fluid by means of a syringe, a second for removing a medical fluid by means of a mandrel having infusion set and a third to provide a so-called needle-free access is used.
  • the sealing element of the third connection device has a slot opening, which makes it possible to attach a conveying device, for example a syringe, with a needle-free connecting piece to the sealing element in order to open the sealing element and to supply a liquid to the container in this way.
  • Legal requirements may make it necessary to wipe or blot the sealing element on its outside before applying a conveying device, for example a hypodermic syringe for supplying a medical fluid or an infusion set for taking out a medical fluid, for disinfecting.
  • EP 1 457 429 A2 describes an overcap serving for pharmaceutical use with a sealing plug made of a soft material.
  • the Overcap has an end opening in which the connection plug is exposed after deduction of a protective cover for piercing a removal cannula.
  • the sealing plug is welded to the overcap. The welding takes place in the absence of the end covering the protective cover.
  • the protective cover can be made of plastic. It can also be an aluminum foil used.
  • a general object of the present invention is to provide a closure cap in which the disinfection of a sealing element arranged thereon is simplified.
  • This object is achieved by an article having the features of claim 1.
  • the cap according to the invention closes an access to a container. For example, the cap closes the opening in the neck of a bottle.
  • the invention is described by a closure cap for a container, in particular for attachment to a container, for receiving a medical fluid, with
  • cap body defining an interior space and having at least one opening
  • Conveyor in a Ansetzraum can be attached, in particular wherein the sealing element is held by a holding device, in particular a, preferably annular, bead, clamped in the cap body,
  • the first terminal means comprises a break-off piece fixedly connected to the cap body in an initial state and the outside of the body
  • the sealing element is flat or substantially flat on its outer side.
  • the sealing element is arranged in particular in such a way in the first closing device, that the outside of the sealing element is accessible after wiping off the Abbrech Partnerss for wiping.
  • the sealing element can be readily accessed by brushing along the top with a suitable disinfecting tool, such as a swab or wiping cloth, to dab or wipe the sealing element on its outside in this manner.
  • a suitable disinfecting tool such as a swab or wiping cloth
  • the outside of the sealing element corresponds to the side of the sealing element, which, after removing the Abbrech Publisheds, is visible from the outside and to a conveyor, such as a syringe or preferably an infusion set or other conveyor, can be attached.
  • a conveyor such as a syringe or preferably an infusion set or other conveyor, can be attached.
  • the outside is thus accessible from the outside, to connect a conveyor to the cap.
  • the sealing element of the first connection device has a central thickness of 2 mm to 5 mm and / or an overall diameter of 4 mm to 14 mm.
  • the outside is advantageously part of a sealing head of the sealing element, which extends through the opening.
  • the sealing element lies with its sealing head in the opening and closes in this way the opening, wherein the outer side formed on the sealing head faces outward and thus faces away from the interior of the closure cap.
  • the sealing head has a diameter of 2 mm to 10 mm, preferably 5 mm to 8 mm.
  • the opening in the closure cap has a diameter of 2 mm to 10 mm, preferably 5 mm to 8 mm. This provides a large access that is particularly compatible with a variety of infusion sets.
  • the sealing head is formed slotted at least in sections. In one embodiment, the slot is stamped in the sealing head. This can help to introduce a spike.
  • the slot preferably extends from the outside to a depth of 0.5 mm to 2 mm.
  • the slot is a cross slot.
  • the first connection device on an outer side of the closure cap comprises a, preferably circular, elevation.
  • a plateau is provided on the cap.
  • the opening of the first connection device is preferably arranged concentrically in the elevation. In particular, this can improve the stability of the first connection device, for example when piercing a spike.
  • a marking which runs around the puncture site at least in sections is arranged on the outside of the sealing element.
  • the puncture area can be further defined or marked.
  • the marking is provided by an at least partially circumferential web.
  • the marking or the web extends as a, preferably interrupted, circle around the puncture site.
  • a kind of target can be formed so that a user can recognize directly the puncture site for the spike. The visibility of the target can be improved in particular by the increase in which the opening of the first connection device is arranged.
  • the sealing element may have a sealing head, which forms the outside, and a sealing body adjoining the sealing head.
  • the sealing body can be connected via a peripheral circumferential flange with a collar, over this collar a clamped connection with the cap is made.
  • the flange extends in such a way that a recess is formed between the sealing head and the annular collar.
  • the sealing body and the flange lie in one plane.
  • the collar can hedge in an associated recess of the cap and are held there by clamping, so that over the annular collar, the sealing element is connected to the closure cap.
  • the sealing element is clamped over a crimping edge.
  • the bead is provided by a bent wall portion.
  • the sealing element is preferably held exclusively by means of clamps in the cap body, in particular in the holding device.
  • an injection cannula or preferably a mandrel of the conveyor can be attached to the outside of the sealing element in order to pierce the sealing element.
  • the sealing element is pushed aside, wherein the annular collar remains on the associated holding device of the closure cap and thus the sealing element is held on the closure cap in position. If the conveyor is again removed from the closure cap, then the sealing element closes automatically, so that the opening of the closure cap in turn against a liquid passage, in particular against leakage of liquid from the container, is sealed.
  • the sealing element is in a preferred embodiment, a resealable sealing element.
  • the sealing element, in particular the sealing element for connecting a mandrel at least partially or continuously slotted.
  • a break-off piece is preferably connected to the cap body such that the sealing element is completely covered towards the outside.
  • the Abbrech consortium encloses the outside of the sealing element and thus closes the outside from the outside, so that no dirt in the form of solid or liquid contaminants can reach the outside.
  • the Abbrech consortium is in the initial state advantageously integrally, ie in one piece, connected to the cap.
  • the closure cap may in this case be produced, for example, together with the break-off piece as a plastic molded part, for example by means of plastic injection molding.
  • the Abbrechmaschine is connected via a predetermined breaking point with the cap body such that the Abbrech collaborate separated along the predetermined breaking point of the cap body, in particular can be canceled to remove the Abbrechfan of the cap body.
  • the predetermined breaking point runs around the opening, so that the break-off piece is connected to the cap body along a connecting line that surrounds the opening and can be separated from the cap body along this connecting line, in order to release the sealing element and a conveying device to the outside of the cap To be able to apply sealing element.
  • at least one edge region of the outside of the sealing element is aligned substantially with the adjacent predetermined breaking line.
  • the accessibility of the sealing element outside can be improved.
  • the outside of the sealing element is substantially aligned with the adjacent predetermined breaking line.
  • an interior or space between the break-off piece and the outside of the sealing element is provided in a sterile manner.
  • the outside of the sealing element is already in the state in which the Abbrech Granules, is still connected to the cap, sterile. Disinfecting the outside of the sealing element after removing the Abbrech proceedingss and before attaching a conveyor, in particular by wiping or blotting, in this case is no longer necessary. But if, for example, legal requirements make such disinfecting necessary, this additional disinfection can be carried out more easily, in particular, by the good accessibility of the outside of the sealing element.
  • the closure cap may also have a second connection device for supplying a medical fluid.
  • Two connection devices are thus provided on the closure cap, one of which is designed in particular for removing a medical fluid and of which the other is designed in particular for supplying a medical fluid.
  • connection devices can be designed differently in order to make it possible to connect different delivery devices, for example an injection syringe or an infusion set.
  • sealing elements of the connection devices can be designed differently.
  • the sealing element of the second connection device can in this case be designed, in particular, for applying an injection syringe, while the sealing element of the first connection device is designed in particular for attaching a mandrel of an infusion set or the like.
  • the sealing elements can thus be adapted in a special way, for example, with regard to their thickness to be pierced in order to allow a convenient connection of a syringe or an infusion set or the like.
  • the sealing element of the second connection device is preferably a resealable sealing element.
  • the sealing element of the second connection device has an at least partially concave outer side.
  • the sealing element of the second connection device can have a sealing head, which forms the outside, and a sealing body adjoining the sealing head.
  • the sealing body is not fixed to a holding device of the cap body by means of a peripheral annular collar connected via a flange, but is held directly over an edge portion of a second holding means of the cap body.
  • this second sealing element can be configured in particular for piercing by means of an injection cannula. Because such an injection cannula has a comparatively small cross-section, there is less deformation on the sealing element when the injection cannula is punctured compared with the piercing of a mandrel, for example an infusion set.
  • the sealing element is preferably held exclusively by means of clamps in the cap body, in particular in the holding device.
  • the sealing elements of the different connection devices can be different in this variant, in particular in their thicknesses, in order to adapt the connection devices the different conveyors.
  • the sealing element of the second connection device (second sealing element), which can serve for attaching an injection cannula of a syringe, may in particular have a greater thickness than the sealing element of the first connection device (first sealing element), which is adapted, for example, for attaching a mandrel of an infusion set.
  • the first sealing element has a central thickness of 2 mm to 6 mm, preferably from 3 mm to 4 mm.
  • the second sealing element has a central thickness of 2 mm to 6 mm, preferably 3 mm to 4 mm.
  • the sealing elements may have an at least approximately rotationally symmetrical shape.
  • the sealing head and the sealing body may each be at least approximately cylindrical, wherein the outside of the sealing head, which faces outward, is substantially planar or concave.
  • the underside of the first and / or second sealing element that provides the inside is substantially planar.
  • the upper side of the annular collar is lower than the upper side of the sealing head and / or the underside of the annular collar is lower than the underside of the sealing body.
  • the first sealing element has an overall diameter of 8 mm to 14 mm, preferably from 10 mm to 12 mm.
  • the second sealing element has an overall diameter of 4 mm to 1 1 mm, preferably from 6 mm to 9 mm.
  • the sealing head of the first sealing element has a diameter of 4 mm to 10 mm, preferably 5 mm to 8 mm and / or the sealing head of the second sealing element has a diameter of 2 mm to 8 mm, preferably from 3 mm to 6 mm.
  • the sealing element of the first connection device and / or the sealing element of the second connection device has at least one spacer. The spacers ensure that the sealing elements can not stick together with their large surfaces during storage.
  • the spacers are arranged in particular where the sealing effect of the sealing elements is not impaired. They are preferably integral with the sealing element.
  • a plurality of spacers are arranged, in particular on the upper side and / or the underside of the annular collar, distributed over the circumference.
  • the spacers are exemplified as elevations or webs. These may extend, for example, radially outward.
  • a plurality of spacers are arranged distributed in particular on the underside of the sealing element.
  • the spacers are designed, for example, as small nubs. The spacers prevent or reduce sticking of the sealing elements during storage. As a result, an automated gripping and insertion of the sealing elements can be supported in the cap body.
  • the sealing element comprises a sealing head, which provides the outer side of the sealing element, a sealing element adjacent to the sealing head and a collar connected to the sealing body via a flange.
  • the outside of the sealing element is substantially planar and lies above an upper side of the annular collar.
  • the sealing element is characterized in that a puncture site in the sealing head is at least partially slotted formed with a Phillips and arranged around the puncture site a partially or at least partially circumferential mark.
  • the sealing element is preferably a sealing element for connection to a mandrel.
  • the sealing element may, in addition to the features mentioned below, also have the features mentioned in the description and in the claims of the sealing element of the first connection device.
  • the slot Due to the configuration of the slot as a cross slot, in particular the visibility of the puncture site in the sealing element and / or the piercing behavior of a spike can be improved.
  • the slot preferably extends from the outside to a depth of 0.5 mm to 2 mm.
  • the marker extends as a circle, preferably interrupted, around the puncture site.
  • the puncture site and the marking are preferably arranged concentrically.
  • a kind of target can be formed so that a user can recognize directly the puncture site for the spike.
  • the marking can be provided for example by an at least partially circumferential ridge or web.
  • a plurality of spacers are arranged distributed on the upper side of the annular collar and / or on the underside of the annular collar over the circumference.
  • the spacers are exemplified as elevations or webs. The spacers prevent or reduce sticking of the sealing elements during storage. As a result, an automated gripping and insertion of the sealing elements can be supported in the cap body.
  • a container preferably a bottle, which comprises a closure cap according to the invention described above or a sealing element described above.
  • the bottle may be made, for example, by SBM (stretch blow molding) or BFS (blow fill seal).
  • SBM stretch blow molding
  • BFS low fill seal
  • the bottle and the closure cap can be connected to each other in particular by means of clamping, gluing and / or welding.
  • the bottle is filled with an infusion solution.
  • FIG. 1A is a perspective view of a cap on a - schematically illustrated - container
  • Fig. 1B is a perspective view of the cap, with removed
  • FIG. 2A is a side view of the closure cap
  • FIG. 2B is a sectional view of the closure cap according to FIG. 2A
  • FIG. 3A is a view of the top of the cap with removed Abbrech Divisionen
  • FIG. 3B is a sectional view (along the section line A-A) of the closure cap according to FIG. 3A, with removal pieces removed;
  • FIG. 4A is a perspective view of the top of the first sealing element
  • 4B is a perspective view of the underside of the first sealing element
  • 4C is a view on the top of the first sealing element
  • Fig. 4D is a sectional view (taken along section line A-A) of the first seal member of Fig. 4C;
  • 5A is a perspective view of the top of the second sealing element; 5B is a perspective view of the underside of the second sealing element;
  • 5C is a view on the top of the second sealing element
  • Fig. 5D is a sectional view (along the section line A-A) of the second
  • FIGS. 1 and 2 show an exemplary embodiment of a closure cap 2, which can be attached to a container 1, in particular in the form of a bottle, for example a plastic bottle or a glass bottle, in order to close the container 1 to the outside and accesses for filling or removing a medical liquid provide.
  • a container 1 in particular in the form of a bottle, for example a plastic bottle or a glass bottle, in order to close the container 1 to the outside and accesses for filling or removing a medical liquid provide.
  • the cap 2 is attached to a container body 10 of the container 1 and connected in a sealing manner with the container body 10, for example, welded or glued.
  • the closure cap 2 has a cap body 20 which has two attachment devices 3, 4 for connecting different delivery devices on an upper side 21.
  • the connection devices 3, 4 each have a sealing element 31, 41, which is accommodated in a holding device 32, 42 in the form of a positive receptacle on the cap body 20 and is held by clamping on the holding device 32, 42.
  • the sealing element 31 and / or the sealing element 41 is or are held exclusively by means of clamps in the cap body, in particular on the holding device 32, 42.
  • the holding devices 32 and 42 are each formed as a, preferably annular, beaded edge.
  • the holding devices 32, 42 are not yet bent.
  • the holding devices 32, 42 are not yet bent.
  • the sealing elements 31, 41 are then inserted into these still empty sleeves 32, 42.
  • the sleeve walls 32, 42 are then bent in the direction of the sleeve interior.
  • the sealing elements 31, 41 are thereby fastened by means of terminals in the respective connection device 3, 4.
  • the beaded edge 32 preferably extends inwards and upwards around the annular collar 314 of the sealing element 31.
  • the beading edge 32 under and engages behind the annular collar 314 of the sealing element 31.
  • the beaded edge 42 extends around the edge portion 413 of the sealing element 41 only substantially inwards.
  • the flanged edge 42 engages below substantially only the edge portion 413 of the sealing element 41st
  • the beading edge 32 and the beading edge 42 are thus formed by bent wall sections and are also recognizable and distinguishable as such, in particular with respect to an injection-molded section.
  • the sealing elements 31, 41 serve to close openings 321, 421 on the upper side 21 of the cap body 20 to the outside, for which purpose in each case a sealing head 310, 410 of the sealing element 31, 41 protrudes into the associated opening 321, 421 and sealingly seals them ,
  • the sealing elements 31, 41 are inserted into the openings 321, 421 at first non-bent holding devices 32 and 42.
  • the holding devices 32 and 42 are then bent.
  • the connecting devices 3, 4 are in an initial state, shown in Fig. 1A, 2A and 2B, each covered by a Abbrech Sharing 30, 40 and closed to the outside, that the openings 321, 421 with the sealing elements 31, 41 of not accessible on the outside and protected against contamination.
  • the interior formed by the Abbrech Published 30, 40 is sterile.
  • the first connection device 3 also comprises an elevation 33 on its upper side.
  • the elevation 33 extends from the upper side of the closure cap 2.
  • the outer edge of the opening 321 is arranged in the outer side of the elevation 33.
  • the elevation 33 is here a circular elevation 33, which extends in particular concentrically around the opening 321. In particular, this can improve the visibility and / or the accessibility of the puncture site in the connection device 3.
  • the stability of the first connection device 3, for example when piercing a spike can also be improved.
  • the elevation 33 has at the transition to the top of the cap 2 to the outside to a greater degree than the center of the cap. 2
  • a second connection device 4 serves to supply a medical fluid into the container 1.
  • the removal of a medical fluid takes place via a delivery device in the form of a, for example, an infusion set Removal device which has a mandrel with a comparatively large cross-section and can be attached with the mandrel to the sealing element 31 of the associated connection device 3.
  • the delivery of a medicinal liquid takes place via a delivery device in the form of an injection syringe, which can be attached with an injection cannula to the sealing element 41 of the associated second connection device 4 in order to puncture the sealing element 41.
  • the sealing element 31 which is rotationally symmetrical in its basic form has a sealing head 310 with a comparatively larger diameter.
  • the sealing head 310 of the first sealing element 31 has a diameter of preferably from 5 mm to 8 mm and / or the sealing head 410 of the second sealing element 41 has a diameter of 4 mm to 6 mm.
  • the opening 421 of the other, second connection device 4 is smaller, and correspondingly, the sealing head 410 of the second sealing element 41 extending into the opening has a comparatively smaller diameter.
  • FIGS. 4A-4D and 5A-5D Detailed, separate illustrations of the sealing elements 31, 41 are shown in FIGS. 4A-4D and 5A-5D.
  • the first sealing element 31 has a sealing head 310 with an outwardly facing, substantially planar outside 31 1.
  • a sealing head 310 includes - back of the outside 31 1 - a sealing body 312, which is connected via a peripheral flange 313 with a likewise circumferentially encircling annular collar 314.
  • the sealing element 31 is located in an opening 320 of the holding device 32 and is held by clamping on the holding device 32.
  • An underside 315 of the sealing element 31 points into an inner space 20 of the closure cap 2 (see, for example, Fig. 4B).
  • the underside 315 of the first sealing element 31 is substantially planar here.
  • the upper side of the annular collar 314 is lower than the outer or upper side 31 1 of the sealing head 310.
  • the underside of the annular collar 314 is lower than the inner or lower side 315 of the first sealing body 31. The annular collar 314 thus extends beyond the underside 315.
  • the other, second sealing element 41 also has a rotationally symmetrical shape and consists of a sealing head 410, at the rear of a substantially concavely curved outer side 41 1, a cylindrical sealing body 412 connects.
  • the sealing element 41 is fixed directly in an opening 420 of the associated, second holding device 42 by a peripheral portion 413 of the sealing element 41 is clamped in the opening 420 of the holding device 42.
  • An underside 414 of the sealing element 41 points towards the interior 200 of the closure cap 2.
  • the underside 414 of the second sealing element 41 is substantially planar here.
  • the different shape in diameter and thickness is due to the fact that when applying a mandrel, the associated, first sealing element 31 in much stronger Measures to be pushed aside as when attaching an injection cannula to the associated, second sealing element 41st
  • the first sealing element 31 can thus be punctured and displaced in a favorable manner when applying a mandrel.
  • both sealing elements 31, 41 close automatically again when the respective associated conveyor is in turn removed from the connection device 3.4.
  • the sealing element 31 on its outer side 31 1 is substantially planar and substantially flush with the top 21 of the cap body 20, the sealing element 31 can be dabbed or wiped in a favorable manner for the purpose of disinfection, as may be required by legal requirements .
  • the outside of the sealing element 31 lies substantially in the same plane as the upper edge of the opening 321.
  • the edge of the outer side of the sealing element 41 is located substantially in the same plane as the edge of the opening 421. This may also be slightly lower , Due to the concave outer side 41 1, the center of the sealing element 41 is lower than the upper edge of the opening 421.
  • the central region of the sealing head 410 has a thickness of 0.1 to 1 mm, thinner than the edge region of the sealing head 410.
  • a suitable disinfecting tool such as a swab or a wipe.
  • connection device 3 For attaching a conveyor to an associated connection device 3, 4 is basically the procedure as follows.
  • the closure cap 2 connected to the container 1 is present with snap-off pieces 30, 40 arranged fixedly thereon.
  • the Abbrech conductede 30, 40 are integrally formed with the cap body 20 and connected by circumferential predetermined breaking points 300, 400 such with the cap body 20 that the outer sides 31 1, 41 1 of the sealing elements 31, 41 are covered to the outside. If a conveyor to an associated terminal device 3, 4 are recognized, the respective Abbrech fabrics 30, 40 is removed from the cap body 20 by a user, the Abbrech Gla 30, 40 between his fingers and engages from the Cap body 20 along the predetermined breaking point 300, 400 breaks off. In this way, the respective sealing element 31, 41 exposed, so that the conveyor to the outside 31 1, 41 1 of the sealing element 31, 41 can be recognized (not shown in the figures).
  • the sealing element 31, 41 is now pierced, so that a flow connection between a body of the respective conveyor and the interior of the container 1 is created, so that a medical liquid can be filled into the container 1 or removed from the container 1 ,
  • the sealing element 31 is slotted starting from its outer side 31 1 sections.
  • the slot 316 is designed here as a cross slot (see in particular Figures 4A to 4D). This cross slot 316 also serves as a marker to emphasize the user the puncture area.
  • elevations or webs 317 are still arranged on the outside 31 1 of the sealing element 31.
  • the piercing region for the spike on the outer side 31 1 of the sealing element 31, which is defined by the intersecting slots 316, is additionally enclosed by an annular peripheral web 317.
  • the annular circumferential ridge 317 is interrupted in each case at several points.
  • the slots 316 extend through the breaks.
  • the webs 317 may be located at the height of the opening edge of the opening 321 or slightly beyond the top 21 of the cap 2 protrude. This is dependent on the contact pressure with which the sealing element 31 is fixed in the opening 321.
  • a plurality of spacers 318 are arranged distributed over the circumference.
  • the spacers 318 are formed as elevations or webs. These extend here by way of example radially outward.
  • a plurality of spacers 418 are arranged distributed on the inner or lower side 414 of the sealing element 41.
  • the spacers 418 are designed here as small nubs. These spacers 318, 418 prevent or reduce the adhesion of the sealing elements 31, 41 during storage. Thereby, an automated gripping and insertion of the sealing elements 31, 41 are supported in the cap body 20.
  • the closure cap 2 may preferably be made of plastic with its cap body 20, for example by means of plastic injection molding.
  • the Abbrech Partners 30, 40 of the connecting devices 3, 4 are in this case first formed integrally with the cap body and can be canceled for accessing one of the sealing elements 31, 41 from the cap body 20.
  • the sealing elements 31, 41 are made of a relatively soft, elastic material, such as polyisoprene or a thermoplastic elastomer.
  • a closure cap can also have only one connection device with one sealing element or more than two connection devices each with a sealing element.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)

Abstract

L'invention concerne un capuchon de fermeture (2) pour un contenant (1) destiné à contenir un liquide médical, ledit capuchon comprenant un corps de capuchon (20), qui délimite un espace intérieur (200) et qui présente au moins une ouverture (321, 421), et au moins un dispositif de raccordement (3, 4) disposé sur le corps de capuchon (20), qui permet le raccordement d'un dispositif de transfert (5, 6) servant à introduire un liquide à usage médical à l'intérieur du contenant (1) ou à extraire d'un liquide médical du contenant (1). Le dispositif de raccordement (3, 4) comporte un élément de scellement (31, 41) disposé sur le corps de capuchon (20) et placé sur l'ouverture (321, 421) aux fins d'en assurer la fermeture étanche, et présentant une face externe (311, 411) à l'opposé de l'espace intérieur (200), sur laquelle le dispositif de transfert (5, 6) vient se positionner dans une direction de positionnement (A) pour être raccordé. L'élément de scellement (31) est maintenu coincé dans le corps de capuchon (20) par un rebord rentrant (32) de préférence annulaire . Ledit au moins un dispositif de raccordement (3, 4) comporte un élément séparable par rupture (30, 40), qui est solidarisé avec le corps de capuchon (20) à l'état initial et qui recouvre la face externe (311, 411) de l'élément de scellement (31, 41) du côté extérieur. L'élément séparable par rupture (30, 40) est formé d'un seul tenant avec le corps de capuchon (20) et est relié au corps de capuchon (20) par une zone de rupture prévue (300, 400) de telle sorte que l'élément séparable par rupture (30, 40) peut être détaché du corps de capuchon (20) le long de la zone de rupture prévue (300, 400). En outre, selon l'invention, l'élément de scellement (31) présente une configuration sensiblement plane sur sa face externe (311) et peut être essuyé. On obtient ainsi un capuchon de fermeture permettant de désinfecter de manière simple et fiable un élément de scellement disposé dans le capuchon de fermeture..
EP17777874.3A 2016-09-28 2017-09-28 Capuchon de fermeture pour un contenant destiné à contenir un liquide médical Pending EP3519315A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP16191179 2016-09-28
PCT/EP2017/074631 WO2018060333A1 (fr) 2016-09-28 2017-09-28 Capuchon de fermeture pour un contenant destiné contenir un liquide médical

Publications (1)

Publication Number Publication Date
EP3519315A1 true EP3519315A1 (fr) 2019-08-07

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP17777874.3A Pending EP3519315A1 (fr) 2016-09-28 2017-09-28 Capuchon de fermeture pour un contenant destiné à contenir un liquide médical

Country Status (11)

Country Link
US (2) US11034491B2 (fr)
EP (1) EP3519315A1 (fr)
KR (1) KR102515690B1 (fr)
CN (2) CN118267296A (fr)
AU (1) AU2017333939B2 (fr)
BR (1) BR112019005427B1 (fr)
CA (1) CA3038173A1 (fr)
CL (1) CL2019000829A1 (fr)
MX (2) MX2019003581A (fr)
WO (1) WO2018060333A1 (fr)
ZA (1) ZA201901817B (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111840069B (zh) * 2020-07-10 2022-11-15 万晶晶 生理盐水容器用密封盖及生理盐水容器
GR1010472B (el) * 2022-10-13 2023-05-31 Σωτηριος Δημητριου Κουρτης Καπακι διπλου ανοιγματος και μεθοδος παραγωγης του

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2906423A (en) 1956-07-18 1959-09-29 American Cyanamid Co Closure puncturable by polyethylene needle
US3900028A (en) * 1974-02-26 1975-08-19 American Hospital Supply Corp Injection site for sterile medical liquid container
DE3310265A1 (de) * 1983-03-22 1984-09-27 Gerhard 7166 Sulzbach-Laufen Hansen Aufreissverschluss fuer einen behaelter
DE3744174A1 (de) 1987-12-24 1989-07-06 Helvoet Pharma Gefriertrocknungs-stopfen
DE19500460A1 (de) * 1995-01-10 1996-07-11 Pohl Gmbh & Co Kg Anordnung an Infusionsflaschen oder dergleichen
US6221056B1 (en) * 1996-12-20 2001-04-24 David G. Silverman Strong diaphragm/safe needle units and components for transfer of fluids
US6340359B1 (en) * 1996-12-20 2002-01-22 David G. Silverman Process for reversibly compressing prechannelled/preweakened diaphragms
DE10127823C1 (de) * 2001-06-07 2002-08-22 West Pharm Serv Drug Res Ltd Verschluss für eine Medikamentenflasche sowie Verfahren zu dessen Herstellung
US20030121878A1 (en) * 2001-12-27 2003-07-03 Finneran James G. Versatile vial and plug system
DE10311154A1 (de) * 2003-03-14 2004-09-23 Helvoet Pharma Belgium N.V. Für pharmazeutische Verwendung dienende Überkappe mit Verschlussstopfen
JP4581331B2 (ja) 2003-03-25 2010-11-17 味の素株式会社 薬剤入り多室バッグ
DE10313760B3 (de) * 2003-03-27 2004-06-03 Fresenius Kabi Deutschland Gmbh Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten
DE102004051300C5 (de) * 2004-10-20 2013-01-24 Fresenius Kabi Deutschland Gmbh Verschlusskappe für mit medizinischen Flüssigkeiten befüllte Behältnisse
US7488311B2 (en) * 2004-12-23 2009-02-10 Hospira, Inc. Port closure system for intravenous fluid container
US20080083691A1 (en) 2006-10-04 2008-04-10 Poynter Richard Q Molded container with raised nipple and method for use
DE102008060864A1 (de) 2008-12-09 2010-06-10 Fresenius Kabi Deutschland Gmbh Verschlusskappe für Behältnisse zur Aufnahme von medizinischen Flüssigkeiten und Behältnis zur Aufnahme von medizinischen Flüssigkeiten
EP2383199B1 (fr) * 2010-04-30 2013-06-12 Sumitomo Rubber Industries, Ltd. Dispositif de fermeture pour récipient et élément d'étanchéité pour le dispositif
JP5758098B2 (ja) * 2010-09-17 2015-08-05 株式会社大協精工 医薬品バイアル用ゴム栓
ES2794602T3 (es) * 2011-02-14 2020-11-18 Becton Dickinson Co Tapa perforable
CA2874118C (fr) * 2012-05-21 2017-09-05 Carmel Pharma Ab Bouchon de protection
WO2015104888A1 (fr) 2014-01-08 2015-07-16 株式会社大塚製薬工場 Couvercle
SG11201704851TA (en) * 2014-12-18 2017-07-28 Otsuka Pharma Factory Inc Port, and Medical Liquid Bag

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Publication number Publication date
US11034491B2 (en) 2021-06-15
BR112019005427A2 (pt) 2019-07-02
AU2017333939B2 (en) 2023-01-19
BR112019005427B1 (pt) 2023-04-18
WO2018060333A1 (fr) 2018-04-05
CN118267296A (zh) 2024-07-02
MX2019003581A (es) 2019-05-27
ZA201901817B (en) 2020-09-30
US20190344939A1 (en) 2019-11-14
CA3038173A1 (fr) 2018-04-05
US20210300643A1 (en) 2021-09-30
AU2017333939A1 (en) 2019-03-28
CN109789953A (zh) 2019-05-21
MX2023008619A (es) 2023-08-07
KR20190062406A (ko) 2019-06-05
KR102515690B1 (ko) 2023-03-29
CL2019000829A1 (es) 2019-07-05

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