SEALING CAP FOR A CONTAINER FOR HOLDING A MEDICAL LIQUID

Abstract

A sealing cap for a container for holding a medical liquid comprises a cap body and a connection device having a sealing element arranged on the cap body. The sealing element is arranged at the opening and is retained in the cap body in a clamped manner by a, preferably annular, flanged rim. The connection device has a break-off piece, which is firmly connected to the cap body and covers an outer face of the sealing element in the outward direction. The break-off piece is integral with the cap body, is connected to the cap body by a predetermined breaking point where the break-off piece can be detached from the cap body. The sealing element outer face is substantially flat and is accessible for wiping to provide a sealing cap having a sealing element arranged that can be simply and reliably disinfected.

Claims

1. A sealing element for a connection device of a container for holding a medical liquid, comprising a sealing head, on an outer side of the sealing element, a sealing body adjoining the sealing head, and a ring collar connected to the sealing body via a flange, wherein the outer side of the sealing element is substantially flat and disposed above a top side of the ring collar.

2. The sealing element of claim 1, wherein a bottom side of the ring collar is situated lower than a bottom side of the sealing body and the ring collar thus extends beyond the bottom side of the sealing body.

3. The sealing element of claim 2, wherein the bottom side of the first sealing element is substantially flat.

4. The sealing element of claim 1, wherein the sealing element is shaped to be pierced by a spike of a conveying device.

5. The sealing element of claim 1, wherein the sealing element reseals automatically when a conveying device is removed from the sealing element.

6. The sealing element of claim 1, further comprising a puncture site in the sealing head configured to be at least partially slotted with a cross slot, and/or a marking that is at least partially circumferential and arranged around the puncture site.

7. The sealing element of claim 6 wherein the marking extends as a broken circle around the puncture site.

8. The sealing element of claim 6, wherein the marking comprises an at least partially circumferential burr.

9. The sealing element of claim 6, wherein the cross slot extends from an outer side of the sealing element into the sealing body of the sealing element to a depth of 0.5 mm to 2 mm.

10. The sealing element of claim 1, wherein the sealing element has at least one spacer.

11. The sealing element of claim 1, wherein on the top side of the ring collar and/or on a bottom side of the ring collar, a plurality of spacers are arranged distributed over the periphery.

12. The sealing element of claim 11, wherein the plurality of spacers comprise elevations or webs that extend radially outward form a central axis of rotation of the sealing element or the plurality of spaces comprise raised bosses distributed on a bottom side of the sealing element.

13. The sealing element of claim 1, wherein the sealing element possesses a central thickness of 2 mm to 6 mm, and/or a total diameter of 4 mm to 14 mm.

14. The sealing element of claim 1, wherein the sealing element possesses a central thickness of 3 mm to 4 mm, and/or a total diameter of 10 mm to 12 mm.

15. The sealing element of claim 1, wherein the sealing head possesses a diameter of 2 mm to 10 mm and/or the first sealing element possesses a total diameter of 8 mm to 14 mm.

16. The sealing element of claim 1, wherein the sealing head possesses a diameter of 5 mm to 8 mm and/or the sealing element possesses a total diameter of 10 mm to 12 mm.

17. The sealing element of claim 1, wherein the outer side of the sealing element is substantially flat in a same plane as an upper rim of an opening of a cap body and lies disposed above a top side of the ring collar.

18. The sealing element of claim 1, wherein the sealing element is dimensioned and configured to contact and fit over an opening of a sealing cap for attachment to a container for holding a medical liquid.

19. The sealing element of claim 18, wherein the ring collar comprises a clamping connection to a sealing cap wherein the ring collar is disposed in an associated recess of a sealing cap and clampingly held there, so that, by contact of the ring collar, the sealing element is connected to the sealing cap, wherein the sealing element is held in a cap body of the sealing cap or cap body holding device solely by means of clamping.

20. The sealing element of claim 18, wherein the sealing element is clampingly held using a beaded rim comprised of a bent-over wall portion.

21. The sealing element claim 1, wherein the sealing element is made of an elastic material, softer than a material comprising a cap body, and further comprising a polyisoprene or a thermoplastic elastomer puncture site.

22. The sealing element claim 1, wherein the sealing element is slotted at least in some sections or throughout for connection of one or more of a conveying device, an injection cannula, or preferably a pin, at the outer side of the sealing element to pierce the sealing element, such that when the sealing element is pushed aside, wherein the ring collar remains on a holding device of a sealing cap and the sealing element is held in position on the sealing cap, such that when the conveying device is removed from the sealing cap, then the sealing element automatically closes as a resealable element, so that the opening of the sealing cap is in turn sealed against passage of liquid out of the container.

23. A container, with an infusion solution disposed therein, comprising a sealing cap with a cap body comprising a sealing element clampingly affixed to, and covering, an opening disposed through the cap body of the sealing cap for dispensing liquids.

Description

[0041] The idea underlying the invention shall be explained in greater detail below with reference to the illustrative embodiments represented in the figures, wherein:

[0042] FIG. 1A shows a perspective view of a sealing cap on a—schematically represented—container;

[0043] FIG. 1B shows a perspective view of the sealing cap, with removed break-off pieces;

[0044] FIG. 2A shows a side view of the sealing cap;

[0045] FIG. 2B shows a sectional view of the sealing cap according to FIG. 2A;

[0046] FIG. 3A shows a view onto the top side of the sealing cap, with removed break-off pieces;

[0047] FIG. 3B shows a sectional view (along the sectional line A-A) of the sealing cap according to FIG. 3A, with removed break-off pieces;

[0048] FIG. 4A shows a perspective view onto the top side of the first sealing element;

[0049] FIG. 4B shows a perspective view onto the bottom side of the first sealing element;

[0050] FIG. 4C shows a view onto the top side of the first sealing element;

[0051] FIG. 4D shows a sectional view (along the sectional line A-A) of the first sealing element from FIG. 4C;

[0052] FIG. 5A shows a perspective view onto the top side of the second sealing element;

[0053] FIG. 5B shows a perspective view onto the bottom side of the second sealing element;

[0054] FIG. 5C shows a view onto the top side of the second sealing element;

[0055] FIG. 5D shows a sectional view (along the sectional line A-A) of the second sealing element from FIG. 5C;

[0056] FIG. 6 shows the same illustration as in FIG. 2B with further reference symbols.

[0057] The figures show an illustrative embodiment of a sealing cap 2 which can be attached to a container 1, in particular in the form of a bottle, for instance a plastics bottle or a glass bottle, in order to seal the container 1 to the outside and provide access channels for the filling or removal of a medical liquid.

[0058] The sealing cap 2 is attached to a container body 10 of the container 1 and sealingly connected, for instance welded or bonded, to the container body 10.

[0059] The sealing cap 2 has a cap body 20, which on a top side 21 has two connection devices 3, 4 for the connection of different conveying devices. The connection devices 3, 4 respectively have a sealing element 31, 41, which is accommodated in a holding device 32, 42 in the form of a positive-locking receptacle on the cap body 20 and is clampingly held on the holding device 32, 42. The sealing element 31 and/or the sealing element 41 is or are held in the cap body, in particular on the holding device 32, 42, solely by means of clamping. In particular, the holding devices 32 and 42 are respectively configured as a, preferably annular, beaded rim.

[0060] In the initial state of the sealing cap 2, with not yet inserted sealing elements 31, 41, the holding devices 32, 42 are not yet bent over. The holding devices 32, 42 extend initially downward and form the walls of a type of empty sleeve (not represented in the figures). Into these still empty sleeves 32, 42 are then respectively inserted the two sealing elements 31, 41. For the fixing of the sealing elements 31, 41, the sleeve walls 32, 42 are subsequently bent over in the direction of the inside of the sleeve. The sealing elements 31, 41 are thereby fastened in the respective connection device 3, 4 by means of clamping. In the first connection device 3, the beaded rim 32 extends preferably around the ring collar 314 of the sealing element 31 in an inward and upward direction. The beaded rim 32 undergrips and back-grips the ring collar 314 of the sealing element 31. In contrast, in the second connection device 4, the beaded rim 42 extends around the marginal portion 413 of the sealing element 41 only substantially inward. The beaded rim 42 undergrips substantially only the marginal portion 413 of the sealing element 41. The beaded rim 32 and the beaded rim 42 are thus formed by bent-over wall portions and are also recognizable and distinguishable as such, in particular in relation to an injection-molded portion.

[0061] The sealing elements 31, 41 serve to outwardly seal openings 321, 421 on the top side 21 of the cap body 20, wherein, to this end, a respective sealing head 310, 410 of the sealing element 31, 41 projects into the associated opening 321, 421 and sealingly closes this off. With holding devices 32 and 42 initially not bent over, the sealing elements 31, 41 are inserted into the openings 321, 421. For the fixing of the sealing elements 31 and 42, the holding devices 32 and 42 are then bent over.

[0062] The connection devices 3, 4 are in an initial state, represented in FIGS. 1A, 2A and 2B, respectively covered via a break-off piece 30, 40 and sealed in the outward direction in such a way that the openings 321, 421, with the sealing elements 31, 41 arranged therein, are not accessible from the outside and are protected against contamination. Preferably, the interior formed by the break-off piece 30, 40 is sterile.

[0063] The first connection device 3 comprises on its top side a further elevation 33. The elevation 33 extends out of the top side of the sealing cap 2. The outer rim 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, the visibility and/or accessibility of the puncture site in the connection device 3 can thereby be improved. In particular, the stability of the first connection device 3, for example upon insertion of a spike, can also be improved. The elevation 33 has, at the transition to the top side of the sealing cap 2 toward the outer side, a larger step than to the center of the sealing cap 2.

[0064] A first connection device 3 serves for the removal of a medical liquid from the container 1. By contrast, another, second connection device 4 serves for the feeding of a medical liquid into the container 1. The removal of a medical liquid is realized via a conveying device in the form of a removal device formed, for instance, by an infusion set, which removal device has a pin of comparatively large cross section and can be attached with the pin to the sealing element 31 of the associated connection device 3. The feeding of a medical liquid is realized, by contrast, via a conveying device in the form of a syringe, which can be attached with an injection cannula to the sealing element 41 of the associated, second connection device 4 in order to pierce the sealing element 41.

[0065] Because the pin of the removal device has a comparatively large cross section, the associated opening 321 of the connection device 3 is also comparatively large, and correspondingly, the, in its basic shape, rotationally symmetric sealing element 31 has a sealing head 310 of comparatively larger diameter. Preferably, the sealing head 310 of the first sealing element 31 possesses a diameter of preferredly from 5 mm to 8 mm, and/or the sealing head 410 of the second sealing element 41 a diameter of 4 mm to 6 mm.

[0066] By contrast, the opening 421 of the other, second connection device 4 is smaller, and correspondingly, the sealing head 410 of the second sealing element 41, which sealing head is extended into the opening, has a comparatively smaller diameter.

[0067] Detailed, separate illustrations of the sealing elements 31, 41 are represented in FIG. 4A-4D and FIG. 5A-5D.

[0068] The first sealing element 31 has a sealing head 310 having an outward pointing, substantially flat outer side 311. Adjoining the sealing head 310—to the rear of the outer side 311—is a sealing body 312, which is connected via a circumferential flange 313 to a likewise peripherally circumferential ring collar 314. Via the ring collar 314, the sealing element 31 lies in an opening 320 of the holding device 32 and is by this means held clampingly on the holding device 32. A bottom side 315 of the sealing element 31 points into an interior 20 of the sealing cap 2 (see, for example, FIG. 4B). The bottom side 315 of the first sealing element 31 is here substantially flat. In the first sealing element 31, the top side of the ring collar 314 is situated lower than the outer side or top side 311 of the sealing head 310. Moreover, the bottom side of the ring collar 314 is situated lower than the inner side or bottom side 315 of the first sealing body 31. The ring collar 314 thus extends beyond the bottom side 315.

[0069] The other, second sealing element 41 likewise has a rotationally symmetric shape and consists of a sealing head 410, which, to the rear of a substantially concavely curved outer side 411, is adjoined by a cylindrical sealing body 412. Via this cylindrical sealing body 412, the sealing element 41 is secured directly in an opening 420 of the associated, second holding device 42, in that a marginal portion 413 of the sealing element 41 is held clampingly in the opening 420 of the holding device 42. A bottom side 414 of the sealing element 41 points toward the interior 200 of the sealing cap 2. The bottom side 414 of the second sealing element 41 is here substantially flat.

[0070] The maximum thickness—viewed along an attachment direction A in which a conveying device is to be attached to a respectively associated sealing element 31, 41—of the first sealing element 31, measured between the outer side 311 and the inner side 315, is smaller than the maximum thickness of the other, second sealing element 41, in turn measured between the outer side 411 and the inner side 414. The different shaping in terms of diameter and thickness is dictated by the fact that, upon the attachment of a pin, the associated, first sealing element 31 has to be pushed aside to a substantially greater extent than when an injection cannula is attached to the associated, second sealing element 41. Upon the attachment of a pin, the first sealing element 31 can thus be favorably pierced and displaced. The same applies to the second sealing element 41 upon attachment of an injection cannula.

[0071] Both sealing elements 31, 41 reseal themselves automatically when the respectively associated conveying device is in turn removed from the connection device 3, 4.

[0072] Because the sealing element 31 is on its outer side 311 substantially flat and is substantially aligned with the top side 21 of the cap body 20, the sealing element 31 can be favorably dabbed or wiped for disinfection purposes, as can possibly be prescribed by legal requirements. Preferably, the outer side of the sealing element 31 lies substantially in the same plane as the upper rim of the opening 321. Preferably, the rim of the outer side of the sealing element 41 also lies substantially in the same plane as the rim of the opening 421. It can also be situated somewhat lower. Due to the concave outer side 411, the center of the sealing element 41 is situated lower than the upper rim of the opening 421. Preferably, the central region of the sealing head 410 possesses a, by 0.1 to 1 mm, lower thickness than the marginal region of the sealing head 410. In particular, due to the shaping of the sealing elements 31, 41 on their outer sides 311, 411 and the positioning in the openings 321, 421, it is possible to ensure that the outer sides 311, 411 can be reached by a suitable disinfecting tool, for instance a swab or a wiping cloth.

[0073] For the attachment of a conveying device to an associated connection device 3, 4, the following procedure is basically adopted.

[0074] In an initial state, the sealing cap 2 connected to the container 1 is present with break-off pieces 30, 40 fixedly arranged thereon. The break-off pieces 30, 40 are configured integrally with the cap body 20 and are connected to the cap body 20 via circumferential predetermined breaking points 300, 400 in such a way that the outer sides 311, 411 of the sealing elements 31, 41 are outwardly covered.

[0075] If a conveying device is intended to be attached to an associated connection device 3, 4, then the respective break-off piece 30, 40 is removed from the cap body 20 by a user gripping the break-off piece 30, 40 between his fingers and breaking it off from the cap body 20 along the predetermined breaking point 300, 400. In this way, the respective sealing element 31, 41 is exposed, so that the conveying device can be attached to the outer side 311, 411 of the sealing element 31, 41 (not represented in the figures).

[0076] By means of a suitable puncturing tool, the sealing element 31, 41 is now pierced, so that a flow connection between a body of the respective conveying device and the inside of the container 1 is created, so that a medical liquid can be filled into the container 1 or removed from the container 1.

[0077] In order to facilitate the insertion of a spike into the sealing element 31, the sealing element 31, starting from its outer side 311, is partially slotted. The slot 316 is here configured as a cross slot (see, in this regard, in particular FIGS. 4A to 4D). This cross slot 316 serves at the same time also as a marking in order to highlight the puncture region to the user. In order to still further improve the visibility of the puncture site, on the outer side 311 of the sealing element 31 are further arranged elevations or webs 317. The insertion region for the spike on the outer side 311 of the sealing element 31, which insertion region is defined by the intersecting slots 316, is additionally enclosed by an annularly circumferential web 317. The annularly circumferential web 317 is respectively broken at several places. The slots 316 extend through the gaps. As a result, a type of target is provided for the user. The webs 317 can lie level with the opening rim of the opening 321, or else project somewhat beyond the top side 21 of the cap 2. That is dependent on the contact pressure with which the sealing element 31 is fixed in the opening 321.

[0078] On the top side and bottom side of the ring collar 314 (of the sealing element 31), a plurality of spacers 318 are arranged distributed over the periphery. The spacers 318 are configured as elevations or webs. These here extend, by way of example, radially outward. Similarly, a plurality of spacers 418 are arranged distributed on the inner side or bottom side 414 of the sealing element 41. The spacers 418 are here configured as small bosses. These spacers 318, 418 prevent or reduce adhesion of the sealing elements 31, 41 during storage. An automated gripping and insertion of the sealing elements 31, 41 into the cap body 20 can thereby be facilitated.

[0079] The sealing cap 2 can, with its cap body 20, preferably be made of plastic, for instance by means of plastic injection molding. The break-off pieces 30, 40 of the connection devices 3, 4 are herein initially formed in one piece with the cap body and can be broken off from the cap body 20 in order to gain access to one of the sealing elements 31, 41.

[0080] While the cap body 20 is made of a comparatively rigid plastics material, the sealing elements 31, 41 are made of a comparatively soft, elastic material, for instance polyisoprene or a thermoplastic elastomer.

[0081] The idea underlying the invention is not limited to the previously depicted illustrative embodiments, but is in principle also able to be implemented in embodiments of wholly different type.

[0082] Since the outward pointing outer side of the sealing elements is easily accessible, the sealing elements can on their outer sides be wiped or dabbed in a simple, effective manner for disinfection purposes.

[0083] In principle, a sealing cap can also have just one connection device, having a sealing element, or more than two connection devices, each having a sealing element.

TABLE-US-00001 Reference symbol list 1 container 10 container body 2 sealing cap 20 cap body 200 interior 21 top side 3 connection device 30 break-off piece 300 predetermined breaking point 31 sealing element 310 sealing head 311 outer side 312 sealing body 313 flange 314 ring collar 315 inner side 316 slot or cross slot 317 marking or burr 318 spacer or web 32 holding device or beaded rim 33 elevation 320 opening 321 opening 4 connection device 40 break-off piece 400 predetermined breaking point 41 sealing element 410 sealing head 411 outer side 412 sealing body 413 marginal portion 414 inner side 418 spacer or boss 42 holding device or beaded rim 420 opening 421 opening A attachment direction