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NZ751365B2 - Sealing cap for a container for holding a medical liquid - Google Patents
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NZ751365B2 - Sealing cap for a container for holding a medical liquid - Google Patents

Sealing cap for a container for holding a medical liquid

Info

Publication number
NZ751365B2
NZ751365B2 NZ751365A NZ75136517A NZ751365B2 NZ 751365 B2 NZ751365 B2 NZ 751365B2 NZ 751365 A NZ751365 A NZ 751365A NZ 75136517 A NZ75136517 A NZ 75136517A NZ 751365 B2 NZ751365 B2 NZ 751365B2
Authority
NZ
New Zealand
Prior art keywords
sealing
sealing element
cap
connection device
break
Prior art date
Application number
NZ751365A
Other versions
NZ751365A (en
Inventor
Torsten Brandenburger
Alexander Degen
Christian Frensch
Andreas Pfeffer
Original Assignee
Fresenius Kabi Deutschland Gmbh
Filing date
Publication date
Application filed by Fresenius Kabi Deutschland Gmbh filed Critical Fresenius Kabi Deutschland Gmbh
Priority claimed from PCT/EP2017/074631 external-priority patent/WO2018060333A1/en
Publication of NZ751365A publication Critical patent/NZ751365A/en
Publication of NZ751365B2 publication Critical patent/NZ751365B2/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1406Septums, pierceable membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1412Containers with closing means, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1412Containers with closing means, e.g. caps
    • A61J1/1431Permanent type, e.g. welded or glued
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/16Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
    • A61L2/18Liquid substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/26Accessories
    • A61L2202/23
    • 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
    • B65D47/00Closures with filling and discharging, or with discharging, devices
    • B65D47/04Closures with discharging devices other than pumps
    • B65D47/06Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages
    • B65D47/12Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages having removable closures
    • 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
    • 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
    • B65D53/00Sealing or packing elements; Sealings formed by liquid or plastics material
    • 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
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient

Abstract

The device relates to a sealing cap (2) for a container (1) for holding a medical liquid, which sealing cap comprises a cap body (20), which bounds an interior (200) and has at least one opening (321, 421), and at least one connection device (3, 4), which is arranged on the cap body (20) and to which a conveying device (5, 6) for feeding a medical liquid into the container (1) or for removing a medical liquid from the container (1) can be connected. The connection device (3, 4) has a sealing element (31, 41), which is arranged on the cap body (20). Said sealing element is arranged at the opening (321, 421) in order to effect closing in a sealing manner and has an outer face (311, 411) facing away from the interior (200), onto which outer face the conveying device (5, 6) can be placed in a placement direction (A) in order to connect the conveying device (5, 6). The sealing element (31) is retained in the cap body (20) in a clamped manner by means of a, preferably annular, flanged rim (32). The at least one connection device (3, 4) has a break-off piece (30, 40), which, in an initial state, is firmly connected to the cap body (20) and covers the outer face (311, 411) of the sealing element (31, 41) in the outward direction. The break-off piece (30, 40) is formed integrally with the cap body (20) and is connected to the cap body (20) by means of a predetermined breaking point (300, 400) in such a way that the break-off piece (30, 40) can be detached from the cap body (20) along the predetermined breaking point (300, 400). In addition, according to the invention, on the outer face (311), the sealing element (31) is substantially flat and is accessible for wiping. In this way, a sealing cap is provided which makes it possible to disinfect a sealing element arranged in the sealing cap in a simple, reliable manner. The sealing cap also consists of a circumferential marking is arranged around the puncture site, wherein the circumferential marking extends as a broken circle so as to form a marking of the insertion region. Thus allowing great ease for the end user to insert a spike.

Claims (36)

CLAIM
1. A sealing cap, for attachment to a container that holds a medical liquid, said sealing 5 cap comprising: a cap body that delimits an interior and that comprises an opening, a first connection device arranged on said cap body, said first connection device comprising a sealing element that is arranged on the cap body and that seals the opening of the cap, wherein the sealing element has: 10 a sealing head that forms an outer side of the sealing element; a sealing body that adjoins the sealing head; a ring collar that holds the sealing body on a first holding device of the cap body, said ring collar having a top side that is lower than that of said sealing head;and 15 a flange that connects the ring collar to the sealing body, said sealing cap further comprising an annular beaded rim that clamps said sealing element to said cap body and, a break-off piece that is integral with said cap body and that connects to said cap body via a predetermined breaking point in such a way that said break-off piece is 20 detachable from said cap body along said predetermined breaking point, said break-off piece having a first state and a second state, wherein, when in said first state, said break- off piece is fixedly connected to said cap body and covers said outer side of said sealing element and wherein, when in said second state, said break-off piece is detached, thereby making said outer side accessible for wiping, 25 wherein an insertion region for a conveying device on the outer side of the sealing element is defined by a circumferential web, wherein the circumferential web extends as a broken circle so as to form a marking of the insertion region.
2. The sealing cap as claimed in claim 1, wherein an interior between the break-off piece 30 and the outer side of the sealing element is provided sterile.
3. The sealing cap as claimed in claim 1 or claim 2, wherein the sealing head of the sealing element extends through the opening, wherein the sealing head is, at least in part, of slotted configuration.
4. The sealing cap as claimed in any one of the preceding claims, wherein the first 35 connection device comprises on an outer side of the sealing cap, a circular elevation and wherein the opening is arranged concentrically in the elevation.
5. The sealing cap as claimed in any one of the preceding claims, wherein, following detachment of the break-off piece, the sealing element has an accessible diameter of 6 mm to 7 mm.
6. The sealing cap as claimed in any one of the preceding claims, wherein the 5 predetermined breaking point runs around the opening and wherein at least a marginal region of the outer side of the sealing element is substantially aligned with the adjacent predetermined breaking line.
7. The sealing cap as claimed in any one of the preceding claims, wherein the sealing cap has a second connection device for feeding of the medical liquid. 10
8. The sealing cap as claimed in claim 7, wherein the second connection device has a sealing element and wherein the sealing element of the second connection device and the sealing element of the first connection device are differently configured to allow for connection of different conveying devices.
9. The sealing cap as claimed in any one of claim 8, wherein the sealing elements, 15 viewed along an attachment direction, have different thicknesses to be pierced by the conveying device.
10. The sealing cap as claimed in claim 9, wherein the sealing element of the second connection device has a sealing head, which forms its outer side, and a sealing body 20 adjoining the sealing head, wherein the sealing body of the second sealing element is held on a second holding device of the cap body via a marginal portion running around the attachment direction.
11. The sealing cap as claimed in claim 10, wherein the sealing element of the second connection device is concave on the outer side. 25
12. The sealing cap as claimed in any one of claims 10 to 11, wherein the second connection device has a break-off piece, which in an initial state is fixedly connected to the cap body and outwardly covers the outer side of the sealing element of the second connection devcice and wherein the break-off piece is connected to the cap body via a predetermined breaking point such that the break-off piece is detachable from the cap 30 body along the predetermined breaking point.
13. The sealing cap as claimed in claim 12, wherein an interior between the break-off piece of the second connection device and the outer side of the sealing element of the second connection device is provided sterile.
14. The sealing cap as claimed in claim 12 or claim 13, wherein the outer side of the sealing element of the second connection device, following the detachment of the break- off piece of the second connection device, is accessible for wiping.
15. The sealing cap as claimed in any one of claims 12 to 14, wherein following the 5 detachment of the break-off piece of the second connection device, the sealing element of the second connection device has an accessible diameter of between 4 mm to 5 mm.
16. The sealing cap as claimed in any one of claims 12 to 15, wherein the predetermined breaking point runs around the opening, and a marginal region of the outer side of the sealing element of the second connection device is substantially aligned with an adjacent 10 predetermined breaking line.
17. A container, preferably a bottle, filled with an infusion solution, comprising a sealing cap as claimed in any one of claims 1 to 16.
18. A sealing cap for attachment to a container that holds a medical liquid, said sealing cap comprising 15 a cap body that delimits an interior and that comprises an opening, a first connection device arranged on said cap body, said first connection device comprising a sealing element that is arranged on the cap body and that seals the opening of the cap, wherein the sealing element has a sealing head that forms an outer side of the sealing element 20 a sealing body that adjoins the sealing head, a ring collar that holds the sealing body on a first holding device of the cap body, said ring collar having a top side that is lower than that of said sealing head, a flange that connects the ring collar to the sealing body 25 said sealing cap further comprising an annular beaded rim that clamps said sealing element to said cap body and a break-off piece that is integral with said cap body and that connects to said cap body via a predetermined breaking point in such a way that said break-off piece is detachable from said cap body along said predetermined breaking point, said break-off 30 piece having a first state and a second state, wherein, when in said first state, said break- off piece is fixedly connected to said cap body and covers said outer side of said sealing element and wherein, when in said second state, said break-off piece is detached, thereby making said outer side accessible for wiping, wherein said first connection device is configured to permit a conveying device, which is oriented in a conveying direction to be attached to said sealing element for removal of said medical liquid from said container, wherein the sealing cap has a second connection device for feeding of a medical 5 liquid, wherein the second connection device has a sealing element and wherein the sealing element of the second connection device and the sealing element of the first connection device are differently configured to allow for connection to different conveying devices, wherein the sealing element of the first connection device and/or the sealing element of the second connection device has at least one spacer, wherein the at least 10 one spacer comprises a boss disposed on an inner side or bottom side of the sealing element, wherein the at least one spacer reduce adhesion of the sealing element during storage thereof, wherein an insertion region for the conveying device on the outer side of the sealing element of the first connection device is defined by an at least partially a 15 circumferential web that extends as a broken circle so as to form a marking of the insertion region.
19. A sealing element for a sealing cap for attachment to a container that holds a medical liquid, the sealing element including: a sealing head that forms an outer side of the sealing element;
20. 20 a sealing body that adjoins the sealing head; a ring collar that holds the sealing body on a first holding device of the cap body, said ring collar having a top side that is lower than that of said sealing head; a flange that connects the ring collar to the sealing body, 25 wherein the outer side of the sealing element is substantially flat and lies above a top side of the ring collar, wherein a puncture site in the sealing head is configured at least partially slotted with a cross slot, and wherein a circumferential marking is arranged around the puncture site and extends as a broken circle around the puncture site so as to form a marking of the puncture site. 30 20. The sealing element as claimed in claim 19, wherein the marking is provided by a, at least partially, circumferential burr.
21. The sealing element as claimed in any one of claims 19 to 20, wherein the cross slot extends from an outer side of the sealing element to a depth of 0.5 mm to 2 mm.
22. The sealing element as claimed in any one of claims 19 to 21, further comprising 35 spacers that are distributed over the periphery of a bottom side of the ring collar.
23. The sealing element of claim 22, wherein the spacers comprise elevations or webs that extend radially outward form a central axis of rotation of the sealing element or the spacers comprise raised bosses distributed on a bottom side of the sealing element.
24. The sealing element of any one of claims 19 to 23, wherein the sealing element 5 possesses a central thickness of 2 mm to 6 mm, and/or a total diameter of 4 mm to 14
25. The sealing element of any one of claims 19 to 23, wherein the sealing element possesses a central thickness of 3 mm to 4 mm, and/or a total diameter of 10 mm to 12 10
26. The sealing element of any one of claims 19 to 25, wherein the sealing head possesses a diameter of 2 mm to 10 mm.
27. The sealing element of any one of claims 19 to 24, wherein the sealing head possesses a diameter of 5 mm to 8 mm.
28. The sealing element of any one of claims 19 to 27, wherein the outer side of the 15 sealing element is substantially flat in a same plane as an upper rim of an opening of the sealing cap body.
29. The sealing element of any one of claims 19 to 28, wherein the sealing element is dimensioned and configured to contact and fit over an opening of the sealing cap for attachment to the container. 20
30. The sealing element of claim 29, wherein the ring collar is disposed in an associated recess of the sealing cap and clampingly held there, so that, by contact of the ring collar, the sealing element is connected to the sealing cap.
31. The sealing element of any one of claims 19 to 30, wherein the sealing element is made of an elastic material, softer than a material comprising the sealing cap, and further 25 comprising a polyisoprene or a thermoplastic elastomer puncture site.
32. The sealing element of any one of claims 19 to 31, 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 a pin, at the outer side of the sealing element to pierce the sealing element, such that when the sealing element is pushed aside, the 30 ring collar remains on a holding device of the 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, 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.
33. The sealing element of any one of claims 19 to 32, wherein a bottom side of the ring collar is situated lower than a bottom side of the sealing body and the ring collar thus 5 extends beyond the bottom side of the sealing body.
34. The sealing element of claim 33, wherein the bottom side of the first sealing element is substantially flat.
35. The sealing element of any one of claims 19 to 34, wherein the sealing element is shaped to be pierced by a spike of a conveying device. 10
36. The sealing element of any one of claims 19 to 35, wherein the sealing element reseals automatically when a conveying device is removed from the sealing element. Fresenius Kabi Deutschland GmbH By the Attorneys for the Applicant SPRUSON & FERGUSON 15 Per:
NZ751365A 2017-09-28 Sealing cap for a container for holding a medical liquid NZ751365B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP16191179 2016-09-28
PCT/EP2017/074631 WO2018060333A1 (en) 2016-09-28 2017-09-28 Sealing cap for a container for holding a medical liquid

Publications (2)

Publication Number Publication Date
NZ751365A NZ751365A (en) 2025-03-28
NZ751365B2 true NZ751365B2 (en) 2025-07-01

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