Wipeable connection system for a medical container
Patent Information
- Application Number
- PCT/EP2026/055514
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2025-02-28
- Filing Date
- 2026-02-27
- Publication Date
- 2026-09-03
Smart Images
Figure EP2026055514_03092026_PF_FP_ABST
Abstract
Description
[0001] FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0002] Wipeable connection system fora medical container
[0003] The invention relates to a connection system for attaching a withdrawal device to a medical container for withdrawing a medical liquid from the medical container as well as a medical container and a medical product comprising the connection system.
[0004] Document WO 2016 / 097346 A1 (Applicant: Fresenius Kabi Deutschland GmbH) discloses a film bag which is filled with a medical solution and has two different connectors for withdrawal purposes. The content of this patent application is fully incorporated into the present patent application by reference.
[0005] The present invention is based on certain improvements to the connection system disclosed in WO 2016 / 097346 A1.
[0006] This problem is solved in respect of the connection system by the features of claim 1. Preferred embodiments are described in the dependent claims, the description and shown in the figures.
[0007] The invention provides a medical container with a connection system that includes an administration connector featuring a port connected to the medical container and a closure cap. The port comprises a tubular channel allowing access to the container's interior, while the closure cap ensures a tamper-evident seal. A resealable sealing element is positioned between the port and the closure cap, providing a fluid-tight transition and maintaining sterility. The sealing element has an accessible diameter after detachment of the break-off part. This allows for easy access and maintenance of the seal. For disinfection purposes the sealing element is accessible for wiping when the break-off part is removed. The sealing element can be dabbed or wiped for disinfection purposes, as can possibly be prescribed by certain national regulatory bodies or medical authorities.
[0008] The invention is described by a medical container with a connection system comprising an administration connector for connecting an administration set, wherein the administration connector comprises: a port connected to the medical container and comprising a port channel for providing access to an interior of the medical container, a closure cap for closing the port channel of the port and comprising a cap body connected to a head section of the port and an upper break-off part connected to the cap body and providing a tamper-evident closure, and a resealable sealing element positioned between the port and the closure cap and fluid-tightly sealing a transition between the port and the closure cap, wherein an upper side of the sealingFK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0009] element flushes with an upper side of the cap body such that the upper side of the sealing element is accessible for wiping after removal of the break-off part.
[0010] According to one embodiment of the invention, the sealing element is clamped between the port head section and the cap body. This configuration enhances the structural integrity and seal reliability of the connection.
[0011] According to one further embodiment of the invention, the port head section features an upper locking ridge, and an anti-rotation toothing above the locking ridge and / or a lower ridge positioned below the ridge. This design prevents rotational movement, ensuring a stable and secure engagement with the closure cap.
[0012] According to one further embodiment of the invention, the port head section includes an upper port top section and a recess. This structural arrangement allows for efficient assembly and connection of the administration set, improving seal properties.
[0013] According to one further embodiment of the invention, the tubular channel of the port is at least partially conical. The conical shape optimizes fluid flow through the channel, reducing the likelihood of blockages. Also clamping of a withdrawal device such as a spike can be promoted ensuring the stable connection during fluid withdrawal or fluid administration.
[0014] According to one further embodiment of the invention, the sealing element comprises a sealing head, a sealing body, and a ring collar, with the sealing head providing a flat outer side. This design ensures even pressure distribution and effective sealing.
[0015] According to one further embodiment of the invention, a puncture site in the sealing head is configured with a cross slot and / or a circumferential marking. This feature facilitates precise and easy access for medical instruments, enhancing usability.
[0016] According to one embodiment of the invention, the cross slot extends to a specified depth. This ensures consistent resealing and maintains sterility after access. Preferably the slot extends laterally and in the depth through the entire sealing head. This enables an improved piercing of the sealing element, for instance with the spike of an administration set. The slot extends partially trough the sealing body only. I.e. the slot extends not through the entire sealing element. The integrity of the sealing element and the content of the container is thereby ensured. Only before fluid administration the sealing element is penetrated via a spike of an administration set to get access to the bag interior.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0017] According to one further embodiment of the invention, the marking around the puncture site extends as a broken circle. This provides visual guidance for accurate instrument insertion.
[0018] According to one further embodiment of the invention, the marking is provided by a circumferential burr. This feature improves alignment during use.
[0019] According to one further embodiment of the invention, spacers are arranged on the ring collar to ensure proper gripping and mounting of the sealing element during assembly.
[0020] According to one further embodiment of the invention, the break-off part of the closure cap is integrally configured with the cap body. This simplifies the manufacturing process and increases durability.
[0021] According to one further embodiment of the invention, the closure cap includes an inner notch to secure it to the locking ridge of the port by snap-fit. This provides an easy and mechanically stable assembly without compromising the seal.
[0022] According to one further embodiment of the invention, the closure cap features a tooth-shaped structure that interacts with the anti-rotation toothing of the port head section. This prevents accidental rotation and ensures a secure fit.
[0023] According to one further embodiment of the invention, the closure cap comprises an inner tubular section forming an inner ring-shaped notch. This accommodates and stabilizes the sealing element, enhancing the sealing effect.
[0024] According to one further embodiment of the invention, the inner tubular section accommodates the sealing head, and the ring-shaped notch holds the ring collar. This ensures a tight and reliable seal.
[0025] According to one further embodiment of the invention, the lower side of the closure cap extends above the recess of the port and at least partially overlaps with the lower ridge of the port. This can provide additional protection against contamination and maintains seal integrity.
[0026] According to one further embodiment of the invention, the connection system includes an injection connector. This enhances versatility by allowing multiple types of medical procedures with a single container. Additives can be injected into the medical solution.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0027] According to one further embodiment of the invention, the sealing elements of the administration and injection connectors are identically configured. This allows for interchangeable use and simplifies inventory management.
[0028] According to one further embodiment of the invention, the port channels of the administration and injection connectors share the same configuration. This ensures consistent fluid dynamics and compatibility across different connectors.
[0029] According to one further embodiment of the invention, the closure caps of the administration and injection connectors have the same geometry and dimensions. This facilitates ease of manufacturing and ensures consistent performance.
[0030] According to one further embodiment of the invention, the break-off part of the administration port features an arrow pointing away from the container, while the injection port's break-off part points toward the container. This provides clear visual indicators for correct usage. According to one embodiment of the invention, the cap bodies of the administration and injection ports include arrows indicating directionality. This aids in correct orientation and connection during use.
[0031] According to one further embodiment of the invention, the medical container is designed as a medical bag with longitudinal and transversal weld seams. This provides structural stability and secure containment of medical liquids.
[0032] According to one further embodiment of the invention, the port of each connector comprises a port foot section. This provides a secure attachment to the container and enhances durability under various conditions.
[0033] According to one further embodiment of the invention, the administration and the injection port share the same port foot section thereby forming a double port. This increases structural integrity and ease of handling. Preferably the port foot section is ship-shaped. This improves welding of port into the weld seam of the container. Leak risk is reduced. The safe and fluid-tight connection between the port and bag can be further improved by providing the port foot section with a base having a plurality of weld rips on the outer side and / or weld flags on the side outer side.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0034] According to one further embodiment of the invention, the medical container is designed to accommodate a filling volume from 50 ml to 5000 ml. This makes it suitable for various medical applications requiring different volumes of liquid.
[0035] The connection system can be suitable as a medical connector system, in particular for the sterile connection of an infusion or dialysis bag or of a rinsing solution bag as containers. According to one embodiment of the invention, the medical container can be filled with an irrigation solution, an intravenous fluid, a pharmaceutical formulation, or a nutritional composition. This offers a versatile solution for medical procedures, particularly in urology and arthroscopy. For irrigation solutions the medical container is designed to accommodate larger filling volumes from 500 ml or 1000 ml up to 5000 ml.
[0036] Embodiments:
[0037] 1. A medical container (100) with a connection system (101) comprising an administration connector (101a) for connecting an administration set, wherein the administration connector (101a) comprises:
[0038] a port (20) connected to the medical container (100) and comprising a port channel (221) for providing access to an interior of the medical container (100),
[0039] a closure cap (40) for closing the port channel (221) of the port (20) and comprising a cap body (41) connected to a head section (23) of the port (20) and an upper break-off part (43) connected to the cap body (41) and providing a tamper-evident closure, and
[0040] a resealable sealing element (30) positioned between the port (20) and the closure cap (40) and fluid-tightly sealing a transition between the port (20) and the closure cap (40), wherein an upper side (311) of the sealing element (30) flushes with an upper side (412) of the cap body (41) such that the upper side (311) of the sealing element (30) is accessible for wiping after removal of the break-off part (43).
[0041] 2. The medical container (100) according to embodiment 1, wherein the sealing element (30) is clamped between the head section (23) of the port (20) and the cap body (41) of the closure cap (40).
[0042] 3. The medical container (100) according to one of the preceding embodiments, wherein the head section (23) of the port (20) comprises an upper locking ridge (233), an anti-rotation toothing (234) above the upper locking ridge (233) and a lower ridge (231) positioned below the upper ridge (233).FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0043] 4. The medical container (100) according to one of the preceding embodiments, wherein the head section (23) of the port (20) comprises a tubular port top section (235) positioned above anti-rotation toothing (234) and a recess (232) positioned between the upper locking ridge (233) and the lower ridge (231).
[0044] 5. The medical container (100) according to one of the preceding embodiments, wherein the port channel (221) of the port (20) is at least partially conical.
[0045] 6. The medical container (100) according to one of the preceding embodiments, wherein the sealing element (30) comprises a sealing head (310), which provides an outer side (311) of the sealing element (30), a sealing body (312) adjoining the sealing head (310), and a ring collar (314) connected to the sealing body (312) via a flange (313), wherein the outer side (311) of the sealing element (30) is substantially flat and lies above a top side of the ring collar (314).
[0046] 7. The medical container (100) according to one of the preceding embodiments, wherein a puncture site in the sealing head (310) is configured at least partially slotted with a cross slot (316), and an at least partially circumferential marking (317) is arranged around the puncture site.
[0047] 8. The medical container (100) according to one of the preceding embodiments, wherein the slot (316) extends laterally and in the depth through the entire sealing head (310) and partially trough the sealing body (312).
[0048] 9. The medical container (100) according to one of the preceding embodiments, wherein the cross slot (316) extends from an outer side (311) of the sealing element (30) to a depth of at least 2 mm and less than a thickness of the sealing body (312).
[0049] 10. The medical container (100) according to one of the preceding embodiments, wherein the marking (317) extends as a, preferably broken, circle around the puncture site.
[0050] 11. The medical container (100) according to one of the preceding embodiments, wherein the marking (317) is provided by an at least partially circumferential burr.
[0051] 12. The medical container (100) according to one of the preceding embodiments, wherein on a top side of the ring collar (314) and / or on a bottom side of the ring collar (314) a plurality of spacers (318) is / are arranged or distributed over the periphery.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0052] 13. The medical container (100) according to one of the preceding embodiments, wherein the sealing element (30) has a, following the detachment of the break-off part (43), accessible diameter of 5 mm to 10 mm, preferably of 6 mm to 7 mm.
[0053] 14. The medical container (100) according to one of the preceding embodiments, wherein the break-off part (43) of the closure cap (40) is configured integrally with the cap body (41) of the closure cap (40).
[0054] 15. The medical container (100) according to one of the preceding embodiments, wherein the closure cap (40) comprises an inner notch (413) for receiving the upper locking ridge (233) of the head section (23) of the port (20) to fix the closure cap (40) to the port (20) by a snap-fit action.
[0055] 16. The medical container (100) according to one of the preceding embodiments, wherein the closure cap (40) comprises on its inside, above the inner notch (413), a tooth-shaped structure (414) to interact with the anti-rotation toothing (234) of the head section (23) of the port (20) as anti-rotation means.
[0056] 17. The medical container (100) according to one of the preceding embodiments, wherein the closure cap (40) comprises an inner tubular section (415) extending from the upper side (412) of the cap body (41) thereby providing an opening in the upper side (412) and forming an inner ring-shaped notch (413).
[0057] 18. The medical container (100) according to one of the preceding embodiments, wherein the inner tubular section (415) of the cap body (41) accommodates the sealing head (310) of the sealing element (30), and the inner ring-shaped notch (413) accommodates the ring collar (314) of the sealing element (30).
[0058] 19. The medical container (100) according to one of the preceding embodiments, wherein the lower side of the closure cap (40) extends such that the closure cap (40) extends above the recess (232) and at least partially overlaps with the lower ridge (231) of the port (20).
[0059] 20. The medical container (100) according to one of the preceding embodiments, wherein the connection system (101) comprises an injection connector (101b).FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0060] 21. The medical container (100) according to one of the preceding embodiments, wherein the sealing element (30) of the administration connector (101a) and a sealing element (30) of the injection connector (101b) are of the same configuration.
[0061] 22. The medical container (100) according to one of the preceding embodiments, wherein the port (20) of the administration connector (101a) and a port (20) of the injection connector (101b) are of the same configuration.
[0062] 23. The medical container (100) according to one of the preceding embodiments, wherein the closure cap (40) of the administration connector (101a) and a closure cap (40) of the injection connector (101b) have the same geometry and the same dimension.
[0063] 24. The medical container (100) according to one of the preceding embodiments, wherein the break-off part (43) of the administration port (101a) comprises an arrow (411) pointing away from the bag (102) and a break-off part (43) of the injection port (101b) comprises an arrow (411) pointing to the bag (102).
[0064] 25. The medical container (100) according to one of the preceding embodiments, wherein the cap body (41) of the administration port (101a) comprises an arrow (411) pointing away from the bag (102) and a cap body (41) of the injection port (101b) comprises an arrow (411) pointing to the bag (102).
[0065] 26. The medical container (100) according to one of the preceding embodiments, wherein the medical container (100) is a medical bag container (102) comprising a longitudinal weld seam (106) and a transversal weld seam.
[0066] 27. The medical container (100) according to one of the preceding embodiments, wherein the port (20) of the administration connector (101a) comprises a port foot section (21) and the port (20) of the injection connector (101b) comprises a port foot section (21).
[0067] 28. The medical container (100) according to one of the preceding embodiments, wherein the port foot section (21) of the administration connector (101a) and the port foot section (21) of the injection connector (101b) are connected via a foot section base (211) carrying both the port channel (221) of the port (20) of the administration connector (101a) and the port channel (221) of the port (20) of the injection connector (101b) thereby forming a double port (20).FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0068] 29. The medical container (100) according to one of the preceding embodiments, wherein the foot section (21) of the port (20) has a ship-shape corpus providing a first channel (214) for the port channel (221) of the port (20) of the administration connector (101a) and a second channel (215) for the port channel (221) of the port (20) of the injection connector (101b).
[0069] 30. The medical container (100) according to one of the preceding embodiments, wherein the medical container (100) has a filling volume of 50 ml - 5000 ml, preferably 500 ml - 5000 ml, more preferably 1000 ml to 4000 ml.
[0070] 31. The medical container (100) according to one of the preceding embodiments, wherein the medical container (100) is filled with an irrigation solution, an intravenous fluid, a pharmaceutical formulation, or a nutritional composition.
[0071] 32. A connection system (101) comprising an administration connector (101a) for a medical container (100), in particular according to one of the preceding embodiments, wherein the administration connector (101a) comprises:
[0072] a port (20) connected to the medical container (100) and comprising a port channel (221) for providing access to an interior of the medical container (100),
[0073] a closure cap (40) closing the port channel (221) of the port (20) and comprising a cap body (41) connected to a port head section (23) of the port channel (221) and an upper break-off part (43) connected to the cap body (41) and providing a tamper-evident closure, and a resealable sealing element (30) positioned between the port (20) and the closure cap (40) and fluid-tightly sealing a transition between the port (20) and the closure cap (40), wherein an upper side (311) of the sealing element (30) flushes with an upper side (412) of the cap body (41) such that the upper side (311) of the sealing element (30) is accessible for wiping after removal of the break-off part (43).
[0074] 33. The connection system (101) according to the preceding embodiment, wherein the port (20) is provided as a double port system (20) comprising the administration connector (101a) and an injection connector (101b) wherein the injection connector (101b) comprises:
[0075] a port channel (221) for providing access to an interior of the medical container (100), a closure cap (40) closing the port channel (221) of the port (20) and comprising a cap body (41) connected to a port head section (23) of the port channel (221) and an upper break-off part (43) connected to the cap body (41) and providing a tamper-evident closure, and a resealable sealing element (30) positioned between the port (20) and the closure cap (40) and fluid-tightly sealing a transition between the port (20) and the closure cap (40),FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0076] wherein an upper side (311) of the sealing element (30) flushes with an upper side (412) of the cap body (41) such that the upper side (311) of the sealing element (30) is accessible for wiping after removal of the break-off part (43).
[0077] The idea underlying the invention shall be explained in greater detail below with reference to the illustrative embodiments represented in the figures, wherein:
[0078] fig. 1A shows a top view of a medical container (filling volume: 3000 ml) equipped with a connection system according to the invention;
[0079] fig. 1 B shows a top view of a medical container (filling volume: 2000 ml) equipped with a connection system according to the invention;
[0080] fig. 1 C shows a top view of a medical container (filling volume: 1000 ml) equipped with a connection system according to the invention;
[0081] fig. 2 shows the (complete and still closed) connection system in a side view (center), in a sectional view along sectional line B-B (left side) and in a sectional view along sectional line A-A (right side);
[0082] fig. 3A shows the connection system of fig. 2 with removed break-off parts; in a side view (upper center), in a sectional view along sectional line B-B (left side), in a sectional view along sectional line A-A (right side) and in a top view (lower center);
[0083] fig. 3B shows the connection system of fig. 3A in a perspective view;
[0084] fig. 3C shows the connection system of fig. 3B in a sectional view;
[0085] fig. 4A shows a perspective view of the port (embodied as a double port);
[0086] fig. 4B shows a side view of the port;
[0087] fig. 4C shows a side view of the port (tilted by 90° with respect to fig. 4B);
[0088] fig. 4.D shows the port of fig. 4.B in a sectional view;FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0089] fig. 5A shows a perspective view of the closure cap (exemplary for the administration connector);
[0090] fig. 5B shows a side view of the closure cap of fig. 5A;
[0091] fig. 5C shows the closure cap of fig. 5.B in a sectional view;
[0092] fig. 6A shows a perspective view onto the top side of the sealing element;
[0093] fig. 6B shows a perspective view onto the bottom side of the sealing element;
[0094] fig. 6C shows a top side of the sealing element;
[0095] fig. 6D shows the sealing in a sectional view along sectional line A-A (upper side) and in a sectional view along sectional line B-B (lower side).
[0096] FIG. 1A illustrates atop view of a medical container 100 designed to hold 3000 ml of a medical fluid, preferably of an irrigation solution, equipped with a connection system 101. The connection system 101 includes both an administration connector 101a and an injection connector 101b, prominently positioned for optimal access. The container 100 integrates a foil or bag 102, a stabilization strip 104 for structural integrity, and a hanging hole 105 for suspension. The longitudinal weld seam 106 and transverse weld seams 107, 108 reinforce the container 100, ensuring durability and secure containment of medical liquids. The stabilization strip 104 supports the hanging hole 105 when hanging during administration. The stabilization strip 104 is welded in the bag 100. It is enclosed or surrounded by welding seams 106, 107 and 108. The container 100 includes a label 103 for identification.
[0097] FIG. 1B shows atop view of a 2000 ml medical container 100, featuring the same connection system 101 with both an administration connector 101a and an injection connector 101b. FIG.
[0098] 1 C presents a top view of a medical container 100 with a 1000 ml capacity.
[0099] FIG. 2 presents a comprehensive view of the connection system 101, depicted in various perspectives to illustrate its complete and closed configuration. These presentations help to understanding how the system integrates with the medical container 100 and functions to maintain sterility and secure fluid management.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0100] At the core of the connection system 101 is the port 20, which serves as the primary interface for accessing the interior of the medical container 100 (see also Fig. 4A to 4D). The port 20 is designed with a port foot section 21, which includes a foot section base 211 that provides a sturdy foundation for attachment to the container 100. The weld rips 212 and the weld flag 213 are integral components of the foot section 211 , ensuring that the port 20 is securely welded to the container's surface. These features are advantageous for maintaining the structural integrity of the connection under various operational conditions.
[0101] The port channel 221 runs through the port 20, providing a pathway for fluid to be transferred from the container 100 to the administration set or other medical devices. The channel's design is optimized for smooth and efficient fluid flow, minimizing resistance and the potential for blockages.
[0102] The port head section 23 is equipped with anti-rotation toothing 234, which interacts with the closure cap 40 to prevent any unintended rotation. This feature ensures that the closure cap 40 remains securely engaged with the port 20, maintaining a reliable seal and preventing leaks.
[0103] The closure cap 40, which seals the port channel 221, is shown in its initial complete configuration. It comprises a cap body 41, designed to fit snugly over the port head section 23. The closure cap 40 includes an upper break-off part 43, which provides tamper-evidence. This part needs to be removed before accessing the sealing element 30, ensuring that the system remains sterile until first use.
[0104] The sealing element 30 is situated between the port 20 and the closure cap 40, playing a crucial role in fluid-tight sealing. The sealing head 310, with its flat outer side 311, ensures even pressure distribution when the cap is engaged (see also Fig. 6Ato 6D). The sealing body 312 supports the sealing head 310 and is connected to a ring collar 314 via a flange 313. This configuration reinforces the sealing element's structure, allowing it to withstand repeated use without compromising its sealing capability.
[0105] The sectional views along lines B-B and A-A provide additional insights into the internal configurations of the connection system 100. These sections reveal how the components interact to create a secure and sterile environment for fluid transfer. The arrangement of the sealing element 30 ensures proper alignment within the port 20, maintaining the integrity of the seal.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0106] FIG. 3A presents a detailed view of the connection system 101 with the break-off parts 43 removed, revealing the internal structure and components designed to facilitate secure and sterile fluid management in the medical container 100. The closure cap 40 is shown without its break-off part 43, exposing the upper side 311 of the sealing element 30 or of the sealing head 310. This design allows for easy cleaning or disinfecting (for instance by wiping) and maintenance, ensuring that the connection system remains sterile and ready for use. The top view highlights the sealing element's surface 311 with a cross slot 316 and marking or burr 317, which preferably aid in precise instrument insertion and / or resealing.
[0107] FIG. 3B shows a perspective view of the connection system 101, emphasizing the ergonomic layout and possibility of improved access to the upper side 311 of the sealing element 30 to enable disinfecting the upper side 311 by wiping or swabbing. The closure cap 40, the port 20, and the sealing element 30 are arranged for user-friendly operation, with features like the anti-rotation toothing 234 ensuring stability.
[0108] The sealing element 30 is prominently displayed, with its sealing head 310 featuring a flat outer side 311. This design ensures uniform contact and pressure distribution when the sealing element 30 is engaged, which is vital for maintaining a consistent seal. The closure cap 40 is shown in an open state, having had its break-off part 43 removed. The cap body 41 fits over the port head section 23, and its design includes features like the inner notch 413 and teeth-shaped structure 414. These elements interact with the port's anti-rotation toothing to ensure a secure and stable fit, preventing accidental dislodgement.
[0109] FIG. 3C presents a sectional view, detailing the mechanical engagement between the port 20, the sealing element 30 and the closure cap 40.
[0110] The closure cap 40 is shown engaged with the port 20, featuring a cap body 41 that fits securely over the port head section 23. The cap body 41 includes an inner notch 413 and a teeth-shaped structure 414, which interact with the anti-rotation toothing 234 and the locking ridge 233 on the port head section 23, ensuring that the closure cap 40 remains securely in place.
[0111] Central to the system is the port 20, which connects to the medical container 100 to facilitate fluid transfer. The port 20 includes a port foot section 21, with a foot section base 211 that anchors the port securely to the container. The weld rip 212 and weld flag 213 are integral to the foot section 21, ensuring a strong weld to the container's surface, which maintains the structural integrity of the connection even under stress.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0112] The port head section 23 features an upper locking ridge 233, a lower ridge 231 and antirotation toothing 234 above the upper locking integrated into the design. The port head section 23, equipped with the anti-rotation toothing 234, is designed to interact with the closure cap 40, preventing any rotational movement that could compromise the seal. These features are advantageous, ensuring that the closure cap 40 remains securely engaged with the port 20, thereby maintaining a reliable seal.
[0113] Within the port 20, the port channel 221 serves as the conduit for fluid flow. This channel 221 is designed for optimal fluid dynamics, allowing fluids to move smoothly and efficiently from the container 100 to the administration set or other connected devices.
[0114] The sealing element 30 is a critical component, prominently displayed in this sectional view. The sealing element 30 is supported by a sealing body 312, which is connected to a ring collar 314 via a flange 313 (see also Fig. 6Ato 6D. The sealing head 310, with its flat outer side 311, ensures consistent pressure distribution and contact, crucial for maintaining a fluid-tight seal. The sealing body 312 supports the sealing head 310 and is connected to the ring collar 314 via the flange 313. This configuration provides structural support and distributes mechanical stress, enhancing the durability and longevity of the sealing element 30.
[0115] FIG. 4Ato 4C illustrate different views on the port system or port 20. The port 20 is integral to facilitating fluid transfer from the medical container 100, and its design ensures both secure attachment and reliable operation.
[0116] FIG. 4A provides a perspective view of the port 20, highlighting its structural design and the features that enable its secure integration into the medical container 100's connection system 101. The port 20 features the port head section 23 with upper ridge 233, lower ridge 231 , and anti-rotation toothing 234 above the upper ridge 233. These features ensure secure engagement with the closure cap 40. Feature 234 prevents rotational movement.
[0117] The anti-rotation toothing 234 is embodied as a kind of serrated flange above the upper locking ridge 233. The upper locking ridge is directly adjacent to the anti-rotation toothing 234 or merges into the anti-rotation toothing 234. The anti-rotation toothing 234 can be integrated into the upper locking ridge 233 as well (not shown). FIG. 4B provides a side view of the port 20, showing the upper locking ridge 233 which is accommodated in inner notch 413 of the closure cap 40 for a snap-fit connection, ensuring stability and a fluid-tight assembly.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0118] At the foundation of the port 20 is the port foot section 21, which includes several key components that anchor the port securely to the container. The foot section base 211 provides a sturdy foundation, enhancing the port's 20 stability when welded to the container 100. The weld rip 212 and weld flag 213 are advantageous for achieving a robust weld to the container's 100 surface, ensuring the structural integrity of the connection even under stress.
[0119] FIG. 4D presents the port 20 in a sectional view, revealing internal configurations such as the port torso section 22 and port head section 23, which supports the sealing element 30 and contribute to consistent performance. The port channel 221 is clearly visible in this presentation, illustrating its role as the conduit for fluid flow from the container 100. As can be seen the ports, in particular the port torsos 22 and the port head sections 23, for the administration connector 101a and the injection connector 101 b are of the same configuration. Both tubular channels 221 are supported by one single foot section 21. Thereby a double-port 20 is provided.
[0120] FIG. 5A showcases a perspective view of the closure cap 40, exemplary for the administration connector 101a. The closure cap 40 for the injection port 101b is not illustrated here. The closure cap 40 for the injection port 101b has the same geometry and the same dimension. The difference is that the arrow 411 on the cap body 41 and the arrow 431 on the break-part 43 point to the medical container 100 indicating the connector to be used as an injection connector 101b. Additives, as for instance trace element, vitamins, minerals and / or drugs can be injected into the container 100 before (patient) administration.
[0121] The closure cap 40 is constructed with a cap body 41 that forms the primary structure of the cap. This cap body 41 is designed to fit snugly over the port head section 23, ensuring a secure and fluid-tight seal. The cap body 41 features an upper side 412, which provides a smooth surface for handling, e.g. disinfection. The closure cap 40 is equipped with the break-off part 43, which serves as a tamper-evident component. This part must be removed before the connector can be used, ensuring that the contents of the medical container 100 remain sterile until first use. The break-off part 43 is designed to detach with suitable effort, allowing for quick access while maintaining the cap's integrity. The shown cap body 41 features an upper side 412 and a break-off part 43 for tamper-evidence, with an arrow 411 indicating the correct use of the connector as an administration connector 101a to withdraw medical liquid form the medical container 100 for (patient) administration.
[0122] FIG. 5B shows a side view of the closure cap 40, emphasizing its ergonomic profile for easy handling and the break-off region 42 between cap body 41 and the break-off part 43. TheFK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0123] break-off part 43, which extends from the cap body 41, serves as a tamper-evident feature, ensuring that the content of the medical container 100 remains sterile until the cap 40 is intentionally opened. The break-off part 43 is engineered to be removed with suitable effort, providing quick access to the interior of the container while maintaining the integrity of the seal. On the exterior of the closure cap 41 , the arrow 411 is visible. This arrow 411 acts as a directional indicator, guiding users on the use of the connector.
[0124] FIG. 5C depicts the closure cap 40 in a sectional view, illustrating features like the innertubular section 415 which accommodate the sealing head 310 of the sealing element 30. Its design also ensures that the sealing element 30 is properly aligned and supported within the cap body 41, maintaining a consistent and effective seal. The inner tubular section 415 and the inner side of the wall of the cap body 41 form the ring-shaped notch or recess 416. This recess 416 accommodates the ring collar 314 of the sealing element 30. This ensures a secure seal. The teeth-shaped structure 414 inside the cap body 41 interacts with the port's anti-rotation toothing 234 to prevent accidental rotation.
[0125] The ring-shaped notch 413 interacts with the upper flange 233 of the head section 23 of the port 20 to enable a stable connection between the closure cap 40 and the port 20 by a snap-fit action. The sealing element 30 is clamped between the cap body 41 of the closure cap 40 and the head section 23 of the port 20 and thereby securely positioned.
[0126] Inside the closure cap 40, the teeth-shaped structure 414 is visible. This structure 411 is designed to interact with the anti-rotation toothing 234 on the port head section 23. The engagement of these features prevents accidental rotation of the closure cap 40, ensuring that it remains securely attached and the seal remains intact during use.
[0127] Detailed illustrations of the sealing element 30 are presented in fig. 6A-6D: FIG. 6A provides a perspective view of the top side 311 of the sealing element 30. The sealing head 310 features a flat outer side 311 with a cross slot 316 for effective sealing and easy access when instruments are inserted. FIG. 6B presents a perspective view of the bottom or inner side 315 of the sealing element 30, showing the sealing body 312, the ring collar 314, and the inner side 315 that maintain its position and structural integrity within the port 20. FIG. 6C displays the top side 311 of the sealing element 30, focusing on the outer surface designed for optimal contact and pressure distribution to prevent leaks.
[0128] FIG. 6D shows the sealing element 30 in sectional views along lines A-A and B-B, detailing the internal structure and material distribution. In a side orientation the slots 316 extendFK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0129] through the entire sealing head 310. This can be well seen in the upper illustration of the FIG.
[0130] 6D showing the sectional view A-A along the slot 316. In the depth orientation the slots 316 do not extend through the entire sealing body 312. This can be well seen both in the upper illustration and the lower illustration of the FIG. 6D. The slots 316 extend through the entire sealing head 310. But the slots 316 extend from the upper side 311 only partially through the sealing body 312. The slots 316 end slightly below the upper side of the flange 313. The closed lower side 315 of the sealing element 30 supports maintaining sterility of the container’s interior until use.
[0131] Preferably the sealing element 30 for the administration port 101a is of the same configuration as the sealing element 30 for the injection port 101b. The sealing element 30 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 30 lies in an opening provided the by tubular channel 415 of the cap body 41. The sealing element 30 is clampingly held between the port head section 23 and the cap body 41. A bottom side 315 of the sealing element 30 points to the interior of the medical container 100. The bottom side 315 of the sealing element 30 is here substantially flat and closed. In the sealing element 30, 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 sealing body 312. The ring collar 314 thus extends beyond the bottom side 315.
[0132] The maximum thickness of the sealing body 312, viewed along an attachment direction in which a conveying device is to be attached to the sealing element 30, is measured between the outer side 311 and the inner side 315. The sealing element 30 reseals itself automatically when the associated conveying device is in turn removed from the administration connector 101a and / or the injection connector 101b.
[0133] The sealing element 30 has a total diameter of 8 mm to 14 mm, preferably 10 mm to 12 mm. The sealing element 30 has a total height of 3 mm to 8 mm, preferably 4 mm to 5 mm. The sealing body 312 has a thickness of 2 mm to 5 mm. preferably 3 mm to 4 mm. The sealing head 312 has a diameter of 5 mm to 10 mm, preferably of 6 mm to 7 mm. The slot 316 has an extension in the depth of at least 2 mm and less than the thickness of the sealing body 312. Preferably the slot 316 extends 2mm to 4 mm, preferably 2,5 mm to 3,5 mm in the sealing body 312. The ring collar 314 has an inner diameter of 6 mm to 12 mm, preferably 8 mm to 10 mm.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0134] Because the sealing element 30 is on its outer side 311 substantially flat and is substantially aligned with the top side 412 of the cap body 41, the sealing element 30 can be favorably dabbed or wiped for disinfection purposes, as can possibly be prescribed by legal requirements. Preferably, the outer side 311 of the sealing element 30 lies substantially in the same plane as the upper rim of the opening of the tubular channel 415. In particular, due to the shaping of the sealing element 30 on its outer side 311 and the positioning in the opening of the cap body 41 , it is possible to ensure that the outer side 311 can be reached by a suitable disinfecting tool, for instance a swab or a wiping cloth.
[0135] For the attachment of a conveying device, as for instance a spike connector of an administration set, to the administration connector 101a, the following procedure is basically adopted. Essentially the same process is applied for the attachment of a conveying device, as for instance a needle syringe, to the injection connector 101b. Generally injecting an additive into the medical container 100 via the injection port 101b takes place in an initial step. Withdrawal of the medical liquid from the medical container 100, for instance for patient administration, wound cleaning, flushing surgical sites, preparing medical preparation etc., takes places in a subsequent step.
[0136] In an initial state, the connection system 100 is closed. The break-off part or piece 43 is still fixedly arranged on the cap body 41. The break-off piece 43 is configured integrally with the cap body 41 and is connected to the cap body 41 via circumferential predetermined breaking points 42 in such a way that the outer side 311 of the sealing element 30 is outwardly covered.
[0137] If a conveying device is intended to be attached to an associated administration connector 101a or injection connector 101b, then the respective break-off piece 43 is removed from the cap body 41 by a user gripping the break-off piece 43 between his fingers and breaking it off from the cap body 41 along the predetermined breaking point 42. In this way, the sealing element 30 is exposed, so that the conveying device can be attached to the outer side 311 of the sealing element 30 (not shown in the figures).
[0138] By means of a suitable puncturing tool, the sealing element 30 is now pierced, so that a flow connection between a body of the respective conveying device and the inside of the container 100 is created, so that a medical liquid can be filled into the container 100 (via the injection connector 101b) or removed from the container 100 (via the administration connector 101a).FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0139] In order to facilitate the insertion of a spike (of an administration set) or a needle (e.g. of a needle syringe) into the sealing element 30, the sealing element 30, 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 figures 6A and 6C). 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, also elevations or webs 317 are arranged on the outer side 311 of the sealing element 30. The insertion region for the spike on the outer side 311 of the sealing element 30, 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 412 of the cap body 41. That is dependent on the contact pressure with which the sealing element 30 is fixed in the opening of the cap body 41.
[0140] On the top side and bottom side of the ring collar 314 of the sealing element 30, 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. These spacers 318 prevent or reduce adhesion of the sealing element 30 during storage. An automated gripping and insertion of the sealing element 30 into the closure cap 40 can thereby be facilitated.
[0141] The closure cap 40 is preferably be made of plastic, for instance by means of plastic injection molding. The break-off piece 43 of the closure cap 40 are herein initially formed in one piece with the cap body 41 and can be broken off from the cap body 41 in order to gain access to the sealing element 30. The port 20 is preferably be made of plastic as well, for instance by means of plastic injection molding. While the closure cap 40 is made of a comparatively rigid plastics material, the sealing element 30 is made of a comparatively soft, elastic material, for instance polyisoprene or a thermoplastic elastomer.
[0142] In certain embodiments, the medical container 100 is filled with a medical fluid, such as an irrigation solution, an intravenous fluid, a pharmaceutical formulation, or a nutritional composition. Thus, the invention also provides a medical product comprising a medical container 100 having a connection system 101 as described herein, wherein the medical container 100 is filled with an irrigation solution, an intravenous fluid, a pharmaceutical formulation, ora nutritional composition.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0143] An irrigation solution refers to a sterile liquid used in an irrigation application, for example during wound cleaning, flushing surgical sites, or preparing medical instruments. Preferably, the irrigation solution is water or an aqueous solution comprising an adjuvant, such as sodium chloride, sodium hypochlorite, potassium chloride, calcium chloride, chlorhexidine, ethylenediaminetetraacetic acid (EDTA), citric acid, etidronic acid, maleic acid, sodium lactate, glycine, sorbitol, mannitol, or mixtures thereof. In certain embodiments, the irrigation solution is selected from water, 0.9% sodium chloride, lactated Ringer's, 1.5% glycine, and sorbitolmannitol.
[0144] An intravenous fluid refers to a sterile liquid intended for intravenous administration to a subject, e.g., a human, to provide fluid and / or electrolytes. Preferably, the intravenous fluid is water or an aqueous solution comprising an adjuvant, such as sodium chloride, potassium chloride, calcium chloride, sodium lactate, sodium acetate, dextrose, or mixtures thereof. In certain embodiments, the intravenous fluid is selected from water, 0.9% sodium chloride, 0.45% sodium chloride, 5% dextrose, lactated Ringer's, 5% dextrose / 0.45% sodium chloride, and 5% dextrose / 0.9% sodium chloride.
[0145] A pharmaceutical formulation refers to a sterile liquid composition intended for administration to a subject, e.g., a human, which comprises a liquid, an active pharmaceutical ingredient (API), and optional excipients. Preferably, the liquid is an intravenous fluid as described herein. The API can be a therapeutic agent, a diagnostic agent, or a combination thereof. Examples of therapeutic agents include, but are not limited to antiinfectives (e.g., antibiotic, antiviral, or antifungal), anesthetics, analgesics, anticoagulants, chemotherapeutics, hormones, antihypertensives, antiinflammatories, antiemetics, bronchodilators, adrenergics, immunoglobulins, antipsychotics, antidepressants, and combinations thereof. Examples of diagnostic agents include, but are not limited to x-ray, MRI and ultrasound contrast agents, cholecystokinetics, vasodilators, and combinations thereof.
[0146] In certain embodiments, the API is an antibiotic such as moxifloxacin, linezolid, levofloxacin, danofloxacin, delafloxacin, levetiracetam, vancomycin, cefepime, aztreonam, cefoxitin, ceftriaxone, cefazolin, cefotaxime, ceftazidime, avibactam, gentamicin, ampicillin, amoxicillin, oxacillin, nafcillin, erythromycin, penicillin, mezlocillin, cyclosporin, cefuroxime, ticarcillin, clavulanic acid, piperacillin, sulbactam, tazobactam, vaborbactam, durlobactam, ceftolozane, cefiderocol, azithromycin, meropenem, ertapenem, tigecycline, minocycline, doxycycline, omadacycline, ceftaroline, daptomycin, dalbavancin, oritavancin, telavancin, sulfamethoxazole, trimethoprim, dalfopristin, quinupristin, teicoplanin, or cefoperazone. In some embodiments, the API a combination of two or more antibiotics, such as avibactam andFK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0147] ceftazidime, ceftolozane and tazobactam, piperacillin and tazobactam, ampicillin and sulbactam, dalfopristin and quinupristin, clavulanic acid and ticarcillin, amoxicillin and clavulanic acid, or sulfamethoxazole and trimethoprim.
[0148] In other embodiments, the API is an antifungal such as micafungin, andulafungin, metronidazole, fluconazole, itraconazole, or posaconazole.
[0149] In other embodiments, the API is a compound useful for pain management, muscle relaxation, sedation, and / or anesthesia. In certain embodiments, the active ingredient is an opioid, a benzodiazepine, beta blocker, or an alpha-2 adrenergic receptor agonist. In particular embodiments, the active ingredient is morphine, hydromorphone, hydrocodone, oxycodone, oxymorphone, codeine, buprenorphine, naloxone, naltrexone, fentanyl, remifentanil, sufentanil, alfentanil, meperidine, rocuronium, vecuronium, midazolam, lorazepam, diazepam, neostigmine, atropine, glycopyrrolate, dexmedetomidine, cisastracurium, ropivacaine, bupivacaine, lidocaine, propofol, ketamine, succinylcholine, sugammadex, or a combination of the foregoing.
[0150] In yet other embodiments, the API is promethazine, dopamine, heparin, enoxaparin, dalteparin, theophylline, acetaminophen (paracetamol), ibuprofen, acetylcysteine, decitabine, azacitidine, docetaxel, pemetrexed, bortezomib, fulvestrant, plerixafor, palonosetron, granisetron, haloperidol, aprepitant, fosaprepitant, dicyclomine, famotidine, amiodarone, nitroglycerin, nicardipine, hydralazine, methyldopate, clevidipine, iloprost, furosemide, dobutamine, esmolol, labetalol, metroprolol, somatropin, lanreotide, liraglutide, abaloparatide, semaglutide, teriparatide, degarelix, sumatriptan, aripiprazole, epinephrine, norepinephrine, ephedrine, pseudoephedrine, phenylephrine, vasopressin, methotrexate, testosterone, estrogen, hydroxyprogesterone, levothyroxine, cetirizine, levocetirizine, diltiazem, verapamil, mexiletine, chlorothiazide, carbamazepine, selegiline, oxybutynin, or a combination of the foregoing.
[0151] A nutritional composition refers to a sterile liquid composition intended for administration to a subject, e.g., a human, which comprises a liquid, a nutrient, and optional excipients. Preferably, the liquid is an intravenous fluid as described herein. Examples of nutrients include, but are not limited to, salts, carbohydrates, minerals, trace elements, vitamins, lipids, and combinations thereof. In some embodiments, the nutrient is selected from vitamin A, vitamin B, cyanocobalamin, thiamine, vitamin C, cysteine, tryptophan, sodium glycerophosphate, chromium, copper, iron, manganese, iodine, fluorine, molybdenum, selenium, zinc, a salt of the foregoing, and / or a combination of the foregoing.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0152] In certain embodiments, the pharmaceutical formulation or nutritional composition comprises a pharmaceutically acceptable excipient, such as a tonicity modifier, antioxidant, buffer, pH adjuster, preservative, solubilizer, stabilizer, or a combination of any of the forgoing.
[0153] 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.
[0154] Reference list
[0155] 100 Medical container or medical bag
[0156] 101 Connection system
[0157] 101a Administration connector or withdrawal connector
[0158] 101b Injection connector
[0159] 102 Foil
[0160] 103 Label
[0161] 104 Stabilization strip or carrier support
[0162] 105 Hanging hole
[0163] 106 Longitudinal weld seam
[0164] 107 T ransverse weld seam
[0165] 108 T ransverse weld seam (for carrier support)
[0166] 20 Port
[0167] 21 Port foot section or weld-in section
[0168] 211 Foot section base
[0169] 212 Weld rip
[0170] 213 Weld flag
[0171] 214 (First) Channel in the port foot section
[0172] 215 (Second) Channel in the port foot section
[0173] 22 Port torso section
[0174] 221 Port channel
[0175] 23 Port head section
[0176] 231 Lower ridge or flange
[0177] 232 Recess
[0178] 233 Upper ridge or flange
[0179] 234 (Anti-rotation) ToothingFK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH
[0180] 235 Port top section
[0181] 30 Sealing element
[0182] 310 Sealing head
[0183] 311 Outer side
[0184] 312 Sealing body
[0185] 313 Flange
[0186] 314 Ring collar
[0187] 315 Inner side
[0188] 316 Slot or cross slot
[0189] 317 Marking or burr
[0190] 318 Spacer or web
[0191] 40 Closure cap
[0192] 41 Cap body
[0193] 411 Arrow
[0194] 412 Upper cap side or top side of the cap
[0195] 413 Inner notch or recess
[0196] 414 (Anti-rotation) Toothing or tooth-shaped structure 415 Tubular section
[0197] 413 Ring-shaped notch or recess
[0198] 42 Break-off section
[0199] 43 Break-off part or piece
[0200] 431 Arrow
Claims
FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbHPatent Claims:
1. A medical container (100) with a connection system (101) comprising an administration connector (101a) for connecting an administration set, wherein the administration connector (101a) comprises:a port (20) connected to the medical container (100) and comprising a port channel (221) for providing access to an interior of the medical container (100),a closure cap (40) for closing the port channel (221) of the port (20) and comprising a cap body (41) connected to a head section (23) of the port (20) and an upper break-off part (43) connected to the cap body (41) and providing a tamper-evident closure, anda resealable sealing element (30) positioned between the port (20) and the closure cap (40) and fluid-tightly sealing a transition between the port (20) and the closure cap (40), wherein an upper side (311) of the sealing element (30) flushes with an upper side (412) of the cap body (41) such that the upper side (311) of the sealing element (30) is accessible for wiping after removal of the break-off part (43).
2. The medical container (100) according to claim 1 , wherein the sealing element (30) is clamped between the head section (23) of the port (20) and the cap body (41) of the closure cap (40).
3. The medical container (100) according to one of the preceding claims, wherein the head section (23) of the port (20) comprises an upper locking ridge (233), an anti-rotation toothing (234) above the upper locking ridge (233) and a lower ridge (231) positioned below the upper ridge (233) and / or wherein the head section (23) of the port (20) comprises a tubular port top section (235) positioned above anti-rotation toothing (234) and a recess (232) positioned between the upper locking ridge (233) and the lower ridge (231).
4. The medical container (100) according to one of the preceding claims, wherein the sealing element (30) comprises a sealing head (310), which provides an outer side (311) of the sealing element (30), a sealing body (312) adjoining the sealing head (310), and a ring collar (314) connected to the sealing body (312) via a flange (313), wherein the outer side (311) of the sealing element (30) is substantially flat and lies above a top side of the ring collar (314).
5. The medical container (100) according to one of the preceding claims, wherein a puncture site in the sealing head (310) is configured at least partially slotted with a cross slot24FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH(316), and an at least partially circumferential marking (317) is arranged around the puncture site.
6. The medical container (100) according to one of the preceding claims, wherein the slot (316) extends laterally and in the depth through the entire sealing head (310) and partially trough the sealing body (312), preferably wherein the cross slot (316) extends from an outer side (311) of the sealing element (30) to a depth of at least 2 mm and less than a thickness of the sealing body (312).
7. The medical container (100) according to one of the preceding claims, wherein the marking (317) extends as a, preferably broken, circle around the puncture site and / or wherein the marking (317) is provided by an at least partially circumferential burr.
8. The medical container (100) according to one of the preceding claims, wherein the closure cap (40) comprises an inner notch (413) for receiving the upper locking ridge (233) of the head section (23) of the port (20) to fix the closure cap (40) to the port (20) by a snap-fit action and / or wherein the closure cap (40) comprises on its inside, above the inner notch (413), a tooth-shaped structure (414) to interact with the anti-rotation toothing (234) of the head section (23) of the port (20) as anti-rotation means.
9. The medical container (100) according to one of the preceding claims, wherein the closure cap (40) comprises an inner tubular section (415) extending from the upper side (412) of the cap body (41) thereby providing an opening in the upper side (412) and forming an inner ring-shaped notch (413) wherein the inner tubular section (415) of the cap body (41) accommodates the sealing head (310) of the sealing element (30), and the inner ring-shaped notch (413) accommodates the ring collar (314) of the sealing element (30).
10. The medical container (100) according to one of the preceding claims, wherein the connection system (101) comprises an injection connector (101b).
11. The medical container (100) according to one of the preceding claims, wherein the sealing element (30) of the administration connector (101a) and a sealing element (30) of the injection connector (101b) are of the same configuration and / or wherein the port (20) of the administration connector (101a) and a port (20) of the injection connector (101b) are of the same configuration and / or wherein the closure cap (40) of the administration connector (101a) and a closure cap (40) of the injection connector (101b) have the same geometry and the same dimension.FK23023-05-PAT-WO Fresenius Kabi Deutschland GmbH12. The medical container (100) according to one of the preceding claims, wherein the break-off part (43) of the administration port (101a) comprises an arrow (411) pointing away from the bag (102) and a break-off part (43) of the injection port (101b) comprises an arrow (411) pointing to the bag (102) and / or wherein the cap body (41) of the administration port (101a) comprises an arrow (411) pointing away from the bag (102) and a cap body (41) of the injection port (101b) comprises an arrow (411) pointing to the bag (102).
13. The medical container (100) according to one of the preceding claims, wherein the medical container (100) is a medical bag container (102) comprising a longitudinal weld seam (106) and a transversal weld seam.
14. The medical container (100) according to one of the preceding claims, wherein a port foot section (21) of the administration connector (101a) and a port foot section (21) of the injection connector (101b) are connected via a foot section base (211) carrying both the port channel (221) of the port (20) of the administration connector (101a) and the port channel (221) of the port (20) of the injection connector (101b) thereby forming a double port (20) and / or wherein the foot section (21) of the port (20) has a ship-shape corpus providing a first channel (214) for the port channel (221) of the port (20) of the administration connector (101a) and a second channel (215) forthe port channel (221) of the port (20) of the injection connector (101b).
15. The medical container (100) according to one of the preceding claims, wherein the medical container (100) has a filling volume of 50 ml - 5000 ml, preferably 500 ml - 5000 ml, more preferably 1000 ml to 4000 ml and / or wherein the medical container (100) is filled with an irrigation solution, an intravenous fluid, a pharmaceutical formulation, or a nutritional composition.
16. A connection system (101) comprising an administration connector (101a) for a medical container (100), in particular according to one of the preceding claims, wherein the administration connector (101a) comprises:a port (20) connected to the medical container (100) and comprising a port channel (221) for providing access to an interior of the medical container (100),a closure cap (40) closing the port channel (221) of the port (20) and comprising a cap body (41) connected to a port head section (23) of the port channel (221) and an upper break-off part (43) connected to the cap body (41) and providing a tamper-evident closure, andFK23023-05-PAT-WO Fresenius Kabi Deutschland GmbHa resealable sealing element (30) positioned between the port (20) and the closure cap (40) and fluid-tightly sealing a transition between the port (20) and the closure cap (40), wherein an upper side (311) of the sealing element (30) flushes with an upper side (412) of the cap body (41) such that the upper side (311) of the sealing element (30) is accessible for wiping after removal of the break-off part (43).
17. The connection system (101) according to the preceding claim, wherein the port (20) is provided as a double port system (20) comprising the administration connector (101a) and an injection connector (101b) wherein the injection connector (101b) comprises:a port channel (221) for providing access to an interior of the medical container (100), a closure cap (40) closing the port channel (221) of the port (20) and comprising a cap body (41) connected to a port head section (23) of the port channel (221) and an upper break-off part (43) connected to the cap body (41) and providing a tamper-evident closure, and a resealable sealing element (30) positioned between the port (20) and the closure cap (40) and fluid-tightly sealing a transition between the port (20) and the closure cap (40), wherein an upper side (311) of the sealing element (30) flushes with an upper side (412) of the cap body (41) such that the upper side (311) of the sealing element (30) is accessible for wiping after removal of the break-off part (43).27