Sealing cap for a container for holding a medical liquid

Abstract

A sealing cap for a container for holding a medical liquid comprising a cap body, which bounds an interior and has at least one opening, and at least one connection device, which is arranged on the cap body and to which a conveying device for feeding a medical liquid into the container or for removing a medical liquid from the container can be connected. The connection device has a sealing element, arranged on the cap body. The connection device has a break-off piece, which, in an initial state, is firmly connected to the cap body and covers the outer face of the sealing element in the outward direction. The break-off piece is connected to the cap body by means of a pre-determined breaking point. In addition, the sealing element is convex on the outer face.

Claims

1. A sealing cap for a container for holding a medical liquid, the sealing cap comprising a cap body and a connecting device that is arranged on the cap body, wherein the connecting device comprises a sealing element arranged on the cap body to seal an opening in the cap body, the sealing element comprising an outside surface that faces away from an interior defined by the cap body and being convex on the outside surface thereof, wherein the outside surface of the sealing element protrudes outward in relation to a top surface off the cap body, a break-off part that, in an initial state, is fixedly connected to the cap body and covers the outside surface of the sealing element, and a pre-determined breaking point that connects the break-off part to the cap body such that the break-off part detaches from the cap body along the predetermined breaking point, wherein the connecting device is connectable to a conveying device that is able to be positioned against the outside surface while conveying medical liquid into the container or drawing medical liquid from the container.

2. The sealing cap as claimed in claim 1, wherein an interior between the break-off part and the outside surface of the sealing element is sterile.

3. The sealing cap as claimed in claim 1, wherein a sealing head of the sealing element extends through the opening and forms the outside surface.

4. The sealing cap as claimed in claim 1, wherein a center of the convex outside surface of the sealing element is above an outer upper edge of a sealing head of the sealing element, wherein the distance between the center and the outer upper edge is between 0.3 millimeters and 0.7 millimeters.

5. The sealing cap as claimed in claim 1, wherein the predetermined breaking point extends around the opening.

6. The sealing cap as claimed in claim 1, wherein the connecting device is a first connecting device for removing a medical liquid and wherein the sealing cap further comprises a second connecting device for supplying a medical liquid.

7. The sealing cap as claimed in claim 6, wherein each connecting device comprises a sealing element and wherein the sealing elements of the connecting devices are identical in structure.

8. The sealing cap as claimed in claim 7, wherein each sealing element comprises a sealing head, which forms the outside surface, and a sealing body which connects to the sealing head, wherein a ring collar that holds the sealing body on a holding device extends around the positioning direction and wherein a flange connects the ring collar to the sealing body.

9. The sealing cap as claimed in claim 6, wherein each connecting device comprises a sealing element and wherein the sealing elements of the connecting devices differ from each other in structure.

10. The sealing cap as claimed in claim 9, wherein the sealing element of the first connecting device comprises a sealing head, which realizes the outside surface, and a sealing body, which connects to the sealing head, wherein a ring collar that extends around the positioning direction holds the sealing body on a first holding device of the cap body, and wherein a flange connects the ring collar to the sealing body.

11. The sealing cap as claimed in claim 9, wherein the sealing element of the second connecting device comprises a sealing head, which forms the outside surface, and a sealing body, which connects to the sealing head and wherein and edge portion, which extends around the positioning direction, holds the sealing body on a second holding device of the cap body.

12. The sealing cap as claimed in one of claim 9, wherein the sealing elements, when viewed along the positioning direction, comprise a different thickness which is to be pierced by the conveying device.

13. The sealing cap of claim 1, wherein the sealing element comprises a sealing head having an outer edge and a convex portion on an outside surface that is remote from an interior of the container and wherein a center of the convex outside surface is between 0.3 millimeters and 0.7 millimeters above the outer edge.

14. The sealing cap of claim 1, wherein the sealing element comprises a sealing head having an outer edge and a convex portion on an outside surface that is remote from an interior of the container and wherein a center of the convex outside surface is between 0.3 millimeters and 0.7 millimeters above the outer edge.

15. A manufacture comprising: a bottle including a sealing cap as recited in claim 1.

16. The manufacture of claim 15, wherein the bottle is filled with an infusion solution.

Description

(1) The concept underlying the invention is to be explained in more detail below by way of the exemplary embodiments shown in the figures, in which:

(2) FIG. 1A shows a perspective view of a sealing cap on a—schematically shown—container;

(3) FIG. 1B shows a part sectioned view of the sealing cap according to FIG. 1A;

(4) FIG. 1C shows a side view of the arrangement according to FIG. 1B;

(5) FIG. 2A shows a perspective view of the sealing cap, with break-off parts removed;

(6) FIG. 2B shows a part sectioned view of the sealing cap according to FIG. 2A;

(7) FIG. 2C shows a side view of the arrangement according to FIG. 2B;

(8) FIG. 3A shows the view according to FIG. 2C, with a conveying device in the form of an injection syringe positioned against a sealing element;

(9) FIG. 3B shows the view according to FIG. 2C, with a conveying device in the form of an infusion set positioned against another sealing element;

(10) FIG. 4A shows a perspective view of a first sealing element;

(11) FIG. 4B shows a side view of the sealing element;

(12) FIG. 4C shows a part sectioned view of the sealing element;

(13) FIG. 4D shows a sectioned view through the sealing element;

(14) FIG. 5A shows a perspective view of a second sealing element;

(15) FIG. 5B shows a side view of the sealing element;

(16) FIG. 5C shows a part sectioned view of the sealing element;

(17) FIG. 5D shows a sectioned view through the sealing element;

(18) FIG. 6A shows a perspective view of a second exemplary embodiment of a sealing cap;

(19) FIG. 6B shows a part sectioned view of the sealing cap according to FIG. 6A;

(20) FIG. 6C shows a side view of the arrangement according to FIG. 6B;

(21) FIG. 7A shows a perspective view of the sealing cap according to FIG. 6A, with break-off parts removed;

(22) FIG. 7B shows a part sectioned view of the arrangement according to FIG. 7A; and

(23) FIG. 7C shows a side view of the arrangement according to FIG. 7B.

(24) FIGS. 1A-1C to FIGS. 5A-5D show a first exemplary embodiment of a sealing cap 2 which can be positioned against a container 1, in particular in the form of a bottle, for example a plastics material bottle or a glass bottle, in order to close the container 1 to the outside and to provide access for filling or removing a medical liquid.

(25) The sealing cap 2 is positioned against a container body 10 of the container 1 and is connected to the container body 10 in a sealing manner, for example welded or bonded.

(26) The sealing cap 2 comprises a cap body 20 which, on a top surface 21, comprises two connecting devices 3, 4 for connecting various conveying devices 5, 6 (see FIGS. 3A and 3B). The connecting devices 3, 4 each comprise a sealing element 31, 41 which is received in a holding device 32, 42 in the form of a positive locking holder on the cap body 20 and is held in a clamping manner on the holding device 32, 42. The holding devices 32 and 42 are each realized, in particular, as a, preferably ring-shaped, beaded rim. The sealing elements 31, 41 serve for the purpose of closing openings 321, 421 on the top surface 21 of the cap body 20 to the outside, in each case, for this purpose, a sealing head 310, 410 of the sealing element 31, 41 projecting into the assigned opening 321, 421 and closing it in a sealing manner. The sealing elements 31, 41 are inserted into the openings 321, 421 with the holding devices 32 and 42 not initially being bent round. The holding devices 32 and 42 are then bent round as shown, for example, in FIG. 1C to fix the sealing elements 31 and 42.

(27) The connecting devices 3, 4 are each covered by a break-off part 30, 40 in an initial state, shown in FIGS. 1A-1C, and are closed to the outside in such a manner that the openings 321, 421 with the sealing elements 31, 41 arranged therein are not accessible from the outside and are protected against contamination. The interior formed by the break-off part 30, 40 is preferably sterile.

(28) A first connecting device 3 serves for removing a medical liquid out of the container 1. A different, second connecting device 4 serves, in contrast, for supplying a medical liquid into the container 1. A medical liquid is removed, as shown in FIG. 3B, by means of a conveying device 6 in the form of a removal device, which is realized, for example, by an infusion set, comprises a mandrel 61 with a comparatively large cross section and can be positioned against the sealing element 31 of the assigned connecting device 3 by way of the mandrel 61. A medical liquid is supplied, in contrast, by means of a conveying device 5 in the form of an injection syringe, which is shown in FIG. 3A and can be positioned by way of an injection cannula 51 against the sealing element 41 of the assigned, second connecting device 4 in order to pierce the sealing element 41.

(29) Because the mandrel 61 of the removal device 6 comprises a comparatively large cross section, the assigned opening 321 of the connecting device 3 is also comparatively large, and the sealing element 31, which is rotationally symmetrical in its basic form, correspondingly comprises a sealing head 310 with a comparatively large diameter. The sealing head 310 of the first sealing element 31 preferably has a diameter in a preferred manner of between 5 mm and 9 mm and/or the sealing head 410 of the second sealing element 41 has a diameter of between 3 mm and 6 mm.

(30) In contrast, the opening 421 of the other, second connecting device 4 is smaller, and the sealing head 410 of the second sealing element 41, which extends into the opening, correspondingly comprises a comparatively small diameter.

(31) Detailed, separate images of the sealing elements 31, 41 are shown in FIGS. 4A-4D and FIGS. 5A-5D.

(32) The first sealing element 31 comprises a sealing head 310 with an outwardly pointing, convex outside surface 311. A sealing body 312, which is connected by means of a circumferential flange 313 to an equally extensively circumferential ring collar 314, connects to the sealing head 310—at the back of the outside surface 311. The sealing element 31 is inserted in an opening 320 of the holding device 32 by means of the ring collar 314 and is held in a clamping manner on the holding device 32 in this manner. A bottom surface 315 of the sealing element 31 points into an interior 20 of the sealing cap 2 (see, for example, FIG. 3A). The bottom surface 31 of the first sealing element 31 is substantially flat here. In the first sealing element 31, the top surface of the ring collar 314 is lower than the outside or top surface 311 of the sealing head 310. In addition, the bottom surface of the ring collar 314 is lower than the inside or bottom surface 315 of the first sealing body 31. The ring collar 314 consequently extends beyond the bottom surface 315.

(33) The other, second sealing element 41 also comprises a rotationally symmetrical form and consists of a sealing head 410, to which at the back of a convexly curved outside surface 411 a cylindrical sealing body 412 connects. The sealing element 41 is fixed directly in an opening 420 of the assigned, second holding device 42 by means of said cylindrical sealing body 412 by an edge portion 413 of the sealing element 41 being held in a clamping manner in the opening 420 of the holding device 42. A bottom surface 414 of the sealing element 41 points toward the interior 200 of the sealing cap 2. The bottom surface 414 of the second sealing element 41 is substantially flat here.

(34) The maximum thickness—when viewed along a positioning direction A in which a conveying device 5, 6 is to be positioned against a respectively assigned sealing element 31, 41 (see FIGS. 3A and 3B)—of the first sealing element 31, measured between the outside surface 311 and the inside surface 315, is smaller than the maximum thickness of the other, second sealing element 41, measured once again between the outside surface 411 and the inside surface 414. The different design in diameter and thickness is brought about as result of the assigned first sealing element 31 having to be urged aside to a considerably greater extent, when a mandrel 61 is positioned, as shown in FIG. 3B, than when an injection cannula 51 is positioned against the assigned second sealing element 41. The first sealing element 31 is consequently able to be pierced and urged in a favorable manner when a mandrel is placed in position.

(35) The same applies to the second sealing element 41 when an injection cannula 51 is placed in position.

(36) Both sealing elements 31, 41 are closed again automatically when the respectively assigned conveying device 5, 6 is removed again from the connecting device 3, 4.

(37) Because the sealing elements 31, 41 are curved in a convex manner on their outside surfaces 311, 411 and additionally protrude outward beyond the top surface 21 of the cap body 20, the sealing elements 31, 41 can be dabbed or wiped in a favorable manner for the purposes of disinfection, as can be proscribed, where applicable, by legal requirements. In particular, the design of the sealing elements 31, 41 on their outside surfaces 311, 411 ensures that the outside surfaces 311, 411 can be reached by a suitable disinfection tool, for example a swab or a wipe, the convex curvature additionally ensuring that disinfecting liquid or other residue does not remain on the outside surface 311, 411 after dabbing or wiping, but rather that the sealing element 31, 41 is able to be wiped in a favorable manner. The central region of the sealing head 310 preferably has a thickness which is thicker than the edge region of the sealing head 310 by between 0.1 mm and 1 mm. The center of the convex region (see FIGS. 4B and 5B in this regard) is between 0.1 and 1 mm and in a preferred manner between 0.3 mm and 0.7 mm above the outer edge.

(38) The procedure for positioning a conveying device 5, 6 against an assigned connecting device 3, 4 is basically as follows.

(39) In an initial state, the sealing cap 2, which is connected to the container 1, is present with the break-off parts 30, 40 arranged fixedly thereon. The break-off parts 30, 40 are realized integrally with the cap body 20 and are connected to the cap body 20 by means of circumferential predetermined breaking points 300, 400 in such a manner that the outside surfaces 311, 411 of the sealing elements 31, 41 are covered toward the outside.

(40) If a conveying device 5, 6 is to be positioned against an assigned connecting device 3, 4, the respective break-off part 30, 40 is removed from the cap body 20 by a user gripping the break-off part 30, 40 between his fingers and breaking it off the cap body 20 along the predetermined breaking point 300, 400. The respective sealing element 31, 41 is exposed in this way such that the conveying device 5, 6 can be positioned against the outside surface 311, 411 of the sealing element 31, 41 (see FIGS. 2A to 2C).

(41) By means of a suitable piercing tool, the sealing element 31, 41 is then pierced such that a flow connection between a body 50, 60 of the respective conveying device 5, 6 and the interior of the container 1 is created such that a medical liquid can be filled into the container 1 or removed out of the container 1.

(42) The sealing cap 2 can be produced with its cap body 20 preferably from plastics material, for example by means of plastics material injection molding. In this connection, the break-off parts 30, 40 of the connecting devices 3, 4 are initially molded in one part with the cap body and can be broken off the cap body 20 to access one of the sealing elements 31, 41.

(43) Whilst the cap body 20 is produced from a comparatively rigid plastics material, the sealing elements 31, 41 are produced from a comparatively soft, elastic material, for example polyisoprene or a thermoplastic elastomer.

(44) In the case of an exemplary embodiment of a sealing cap 2 shown in FIGS. 6A-6C and 7A-7C, the connecting devices 3, comprise identical sealing elements 31, 41 which are arranged in a clamping manner in holding devices 32, 42 which are structurally identical to one another. The form of the sealing elements 31, 41, in this connection, corresponds to the realization shown in FIGS. 4A-4D.

(45) Once again, one connecting device 3 serves for removing a medical liquid out of a container 1 which is connected to the sealing cap 2, whilst the other connecting device 4 serves for filling a medical liquid. One conveying device 5 in the form of an injection syringe with an injection cannula or a conveying device with a mandrel can be used, in this connection, both for removing and for filling.

(46) The exemplary embodiment according to FIGS. 6A-6C and FIGS. 7A-7C is otherwise identical to the previously described exemplary embodiment such that reference is to be made to the above statements.

(47) The concept underlying the invention is not restricted to the exemplary embodiments depicted above, but can also be realized, in principle, in completely different embodiments.

(48) As a result of the outwardly pointing outside surface of the sealing elements being realized in a convex manner and preferably protruding outwardly beyond a front surface of the cap body of the sealing cap (when the break-off parts of the connecting devices have been removed), the sealing elements are able to be wiped or dabbed on their outside surfaces in an easy, effective manner for the purposes of disinfection.

(49) In principle, a sealing cap can also comprise only one connecting device with one sealing element or more than two connecting devices each with one sealing element.

(50) It is equally conceivable, in principle, for only one sealing element of several sealing elements of several connecting devices to be realized in a convexly curved manner on its outside surface.

LIST OF REFERENCES

(51) 1 Container

(52) 10 Container body

(53) 2 Sealing cap

(54) 20 Cap body

(55) 200 Interior

(56) 21 Top surface

(57) 3 Connecting device

(58) 30 Break-off part

(59) 300 Predetermined breaking point

(60) 31 Sealing element

(61) 310 Sealing head

(62) 311 Outside surface

(63) 312 Sealing body

(64) 313 Flange

(65) 314 Ring collar

(66) 315 Inside surface

(67) 32 Holding device

(68) 320 Opening

(69) 321 Opening

(70) 4 Connecting device

(71) 40 Break-off part

(72) 400 Predetermined breaking point

(73) 41 Sealing element

(74) 410 Sealing head

(75) 411 Outside surface

(76) 412 Sealing body

(77) 413 Edge portion

(78) 414 Inside surface

(79) 42 Holding device

(80) 420 Opening

(81) 421 Opening

(82) 5 Injection device

(83) 50 Body

(84) 51 Injection needle

(85) 6 Removal device

(86) 60 Body

(87) 61 Mandrel

(88) A Positioning direction