Container for parenterally delivering a medicinal and / or nutritional product, protection cover, and method for manufacturing a container
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2026-02-02
- Publication Date
- 2026-08-13
Smart Images
Figure IB2026050969_13082026_PF_FP_ABST
Abstract
Description
B. Braun Melsungen AG Munich, 2 February 2026 Our Reference: B19068EPCONTAINER FOR PARENTERALLY DELIVERING A MEDICINAL AND / OR NUTRITIONAL PRODUCT, PROTECTION COVER, AND METHOD FOR MANUFACTURING A CONTAINERTECHNICAL FIELD
[0001] The present invention relates to a container for parenterally delivering a medicinal and / or nutritional product. The container comprises a first flexible film and a second flexible film. The first flexible film and the second flexible film are located on top of each other, wherein at least one product chamber for the medicinal and / or nutritional product is delimited by the mutually opposite sides of the first flexible film and the second flexible film, and by a seam locally connecting the first flexible film and the second flexible film. Moreover, the container comprises a connector piece partially interposed between the first flexible film and the second flexible film and partially extending from the product chamber. The connector piece is connected to the first flexible film and the second flexible film. The connector piece comprises at least one connection interface for withdrawing the medicinal and / or nutritional product from the product chamber, wherein the at least one connection interface is arranged on the portion extending from the product chamber.
[0002] Additionally, the present invention is directed to a protection cover for such a container.
[0003] The present invention further relates to a method for manufacturing such a container.BACKGROUND
[0004] Such containers for parenterally delivering medicinal and / or nutritional products are known. Since medicinal and / or nutritional products often are sensitive to oxygen and / or carbon dioxide, it is usual to provide such containers with an overwrapping in order to enhance storage life. In simplified words, such containers are put in a protective bag in order to prevent deterioration of the medicinal and / or nutritional product caused by oxygen and / or carbon dioxide. This overwrapping accounts for production steps and handling steps that go beyond the production of the container.NB:TOPSUMMARY
[0005] Consequently, it is an objective of the present invention to facilitate handling and production of such containers for parenterally delivering a medicinal and / or nutritional product. At the same time, a long storage life shall be ensured.
[0006] According to a first aspect of the invention, there is provided a container for parenterally delivering a medicinal and / or nutritional product. The container comprises a first flexible film and a second flexible film. The first flexible film and the second flexible film are located on top of each other, wherein at least one product chamber for the medicinal and / or nutritional product is delimited by the mutually opposite sides of the first flexible film and the second flexible film and by a seam locally connecting the first flexible film and the second flexible film. Moreover, the container comprises a connector piece partially interposed between the first flexible film and the second flexible film and partially extending from the product chamber. The connector piece is connected to the first flexible film and the second flexible film. The connector piece comprises at least one connection interface for withdrawing the medicinal and / or nutritional product from the product chamber, wherein the at least one connection interface is arranged on the portion extending from the product chamber.Additionally, the container comprises a protection cover enclosing the at least one connection interface, wherein the protection cover comprises an oxygen barrier and / or a carbon-dioxide barrier. This configuration of the container is based on the finding that the connection interface is the principal point of connection of the at least one product chamber and an environment comprising oxygen and / or carbon dioxide. In other words, it has been found that a potential deterioration of the medicinal and / or nutritional product in the at least one product chamber is mainly due to the ingress of oxygen and / or carbon dioxide which happens via the connection interface. This phenomenon may be reliably suppressed using the protection cover enclosing the at least one connection interface. Thus, in contrast to the known overwrapping as described above, the protection cover does not enclose the entire container but only the critical portion thereof. More precisely, the protection cover encloses a portion of theconnector piece which comprises the connection interface. Consequently, the protection cover may be comparatively small. Thus, the protection cover requires less material than a full overwrapping and, thereby, renders the container compact. Still, the at least one product chamber may be efficiently and effectively protected from the ingress of oxygen and / or carbon dioxide. Furthermore, the present configuration of the container is advantageous with respect to a full overwrapping in that keeping the major portions of the container free from overwrapping allows to have a better heat distribution during potential sterilization steps. Furthermore, an outer surface of the first flexible film and the second flexible film is kept accessible, e.g. for printing a label thereon.
[0007] In the context of the present disclosure, parenterally delivering a medicinal and / or nutritional product means that the medicinal and / or nutritional product is delivered via a route other than the gastrointestinal tract of a human body or animal body, i.e. not enterally. In this context, parenterally delivering a medicinal and / or nutritional product may involve infusing or injecting the medicinal and / or nutritional product. The infusion or injection may be intramuscular, intravenous or intrathecal.
[0008] It is noted that in the present disclosure, the protection cover forms part of the container and the protection cover is fixedly connected or joined to the remaining parts of the container, if the container is in a storage state.
[0009] It is further noted that the fact that the at least one connection interface is suitable for withdrawing the medicinal and / or nutritional product from the product chamber, does not exclude that the connection interface, additionally, is suitable for adding a medicinal and / or nutritional product to the product chamber.
[0010] According to an example, the container comprises a hanger or hanger interface configured for hanging the container on a stand when delivering the medicinal and / or nutritional product. The hanger interface may be arranged at an end of the container opposite the connector piece. Consequently, the container may be held at a well-defined position at a vertical level above the point at which the medicinal and / or nutritional product reaches the human body or animal body.
[0011] Due to the fact that, according to the present invention, the protection cover essentially covers a portion of the connector piece which comprises the connection interface, the protection cover is small as compared to the product chamber of the container. In an example, in which a height direction of the container is defined by a direction extending between a hanger interface of the container and the connector piece, a height of the protection cover may be 30 % or less of a height of the product chamber. Preferably, the height of the protection cover may be 25 % or less of a height of the product chamber. Further preferably, the height of the protection cover may be 20 % or less of a height of the product chamber. According to another example, a height of the protection cover is smaller than 300% of a height of the connector piece. Preferably, a height of the protection cover is smaller than 250% of a height of the connector piece. Further preferably, a height of the protection cover is smaller than 200% of a height of the connector piece.
[0012] In the context of the present disclosure, the connector piece may comprise a pierceable port, i.e. a port that needs to be pierced for being opened. For example, a hollow needle may be used for piercing the port. Such a port is advantageous for keeping the medicinal and / or nutritional product sterile.
[0013] It is additionally noted that the connection interface may be formed as a so-called monoport or twin port. In any case, the connection interface is fully covered by the protection cover.
[0014] According to an example, the protection cover comprises a flexible film. Thus, the protection cover is comparatively light and compact. Furthermore, the protection cover may be easily installed and withdrawn from the remaining components of the container. In this context, the oxygen barrier and / or the carbon dioxide barrier may form part of the flexible film, e.g. if the flexible film is formed as a multi-layer film.
[0015] Due to the fact that the container comprises the first flexible film and the second flexible film, the container may as well be called a bag.
[0016] The flexible film may comprise polypropylene, polyethylene terephthalate, silicon oxide, and / or any other suitable material. In an example, the flexible film comprises twolayers, wherein one layer comprises polypropylene and the other layer comprises silicon oxide. In another example, the flexible film comprises two layers, wherein one layer comprises polyethylene terephthalate and the other layer comprises silicon oxide. In a further example, the flexible film comprises three layers, wherein the two outer layers comprise polypropylene, e.g. a polypropylene copolymer, and the layer in the middle comprises polyethylene terephthalate, silicon oxide and another barrier coating. In still another example, the flexible film comprises four layers, wherein the two outer layers comprise polypropylene and one of the two layers in between these outer layers comprises polyethylene terephthalate and the other layer in between these outer layers comprises silicon oxide.
[0017] It is noted that in case a layer comprising silicon oxide needs to be connected to a polypropylene layer, an adhesive is needed. In the context of the present invention, this adhesive is not counted as a separate layer.
[0018] According to a variant, the protection cover comprises a third flexible film and a fourth flexible film. The third flexible film and the fourth flexible film are located on top of each other, wherein a space for the at least one connection interface is delimited by the mutually opposite sides of the third flexible film and the fourth flexible film and by a seam locally connecting the third flexible film and the fourth flexible film. In this context, the protection cover may be called a bag which is made from the third flexible film and the fourth flexible film. The seam locally connecting the third flexible film, and the fourth flexible film may be a permanent seam. In this case, the protection cover needs to be withdrawn as a whole in order to access the connection interface. Alternatively, the seam locally connecting the third flexible film, and the fourth flexible film may be a rupturable or peelable seam. In this case, the connection interface may be rendered accessible by separating the third flexible film and the fourth flexible film in that the rupturable or peelable seam is opened. All of these alternatives form a good compromise between reliable protection of the connection interface and comparatively easy accessibility, if needed.
[0019] According to another variant, the flexible film of the protection cover is folded such that a first portion of the flexible film and a second portion of the flexible film are located ontop of each other, wherein a space for the at least one connection interface is delimited by the mutually opposite portions of the flexible film and by a seam locally connecting the portions of the flexible film. Also in this context, the protection cover may be called a bag. However, in contrast to the afore-mentioned example, the protection cover is made from one single flexible film only which is folded. The seam locally connecting the portions of the flexible film may be a permanent seam. In this case, the protection cover needs to be withdrawn as a whole in order to access the connection interface. Alternatively, the seam locally connecting the portions of the flexible film may be a rupturable or peelable seam. In this case, the connection interface may be rendered accessible by separating the portions of the flexible film in that the rupturable or peelable seam is opened. All of these alternatives form a good compromise between reliable protection of the connection interface and comparatively easy accessibility, if needed.
[0020] According to still another variant, the protection cover is formed by a protection portion of the first flexible film and / or a protection portion of the second flexible film. A space for the at least one connection interface is delimited by the protection portion of the first flexible film and / or the protection portion of the second flexible film and by a seam locally connecting the protection portion of the first flexible film and / or the protection portion of the second flexible film. This covers three alternatives. In a first alternative, the protection cover is formed by a protection portion of the first flexible film. In this context, the protection portion may be folded such that a first portion of the protection portion and a second portion of the protection portion are located on top of each other, wherein a space for the at least one connection interface is delimited by the mutually opposite portions of the protection portion and by a seam locally connecting the portions of the protection portion. In a second alternative, the protection cover is formed by a protection portion of the second flexible film. In this context, the protection portion may be folded such that a first portion of the protection portion and a second portion of the protection portion are located on top of each other, wherein a space for the at least one connection interface is delimited by the mutually opposite portions of the protection portion and by a seam locally connecting the portions of theprotection portion. In a third alternative, the protection cover is formed by a protection portion of the first flexible film and by a protection portion of the second flexible film. In this context, the space for the at least one connection interface may be delimited by the two protection portions and by a seam locally connecting the protection portions. As has been explained before, the seams can be permanent seams or rupturable or peelable seams. A configuration in which the protection cover is formed by a protection portion of the first flexible film and / or a protection portion of the second flexible film is advantageous in that the protection cover for the connection interface is integrally formed with the first flexible film and / or the second flexible film. This renders the container structurally simple and compact.
[0021] The protection portion of the first flexible film may be delimited from the remaining portions of the first flexible film by a tear-off feature. Additionally or alternatively, the protection portion of the second flexible film may be delimited from the remaining portions of the second flexible film by a tear-off feature. The tear-off feature facilitates separating the protection portion from the remaining portions of the first flexible film and / or the remaining portions of the second flexible film. The tear-off feature may be formed by a locally weakened portion of the first flexible film and / or the second flexible film. It is emphasized, that the locally weakened portion is weakened in the mechanical sense only. The functionalities relating to the oxygen barrier and / or the carbon dioxide barrier are not weakened. Altogether, the tear-off feature facilitates accessing the connection interface if needed.
[0022] In an example, the protection cover is connected to the connector piece. For example, the protection cover can be welded or adhesively connected to the connector piece. In case the protection cover is welded to the connector piece, the weld seam may be permanent or rupturable. Consequently, the protection cover is reliably connected to the connector piece, thereby reliably enclosing the connection interface.
[0023] In another example, the protection cover is connected to the first flexible film and / or to the second flexible film. For example, the protection cover can be welded or adhesively connected to the first flexible film and / or to the second flexible. In case the protection cover iswelded to the first flexible film and / or the second flexible film, the weld seam may be permanent or rupturable. Consequently, the protection cover is reliably connected to the first flexible film as the short the second flexible film, thereby reliably enclosing the connection interface.
[0024] In an example, an oxygen absorber and / or an oxygen indicator may be arranged inside the protection cover. In this context, an oxygen absorber is a device or material configured to absorb oxygen. Consequently, the storage life of the container may be even further enhanced, since oxygen is withheld from the at least one product chamber. An oxygen indicator is understood as a device or material that is configured to indicate the presence of oxygen.Consequently, using an oxygen indicator that is arranged inside the protection cover, offers the possibility to know whether oxygen is present inside the protection cover and / or an amount of oxygen present inside the protection cover. This allows to draw conclusions on the remaining storage life of the container.
[0025] According to another example, an identification device and / or an information carrier is arranged inside the protection cover. Using the identification device and / or the information carrier, an information on identity of the container and / or information describing the container may be provided to a user of the container in a simple and reliable manner. An example of an identification device is an RFID tag. In a simple case, the information carrier may be a leaflet.
[0026] According to a second aspect of the invention, there is provided a protection cover for a container according to the invention. The protection cover comprises a space for the at least one connection interface of the container and a mounting interface for connecting the protection cover to the connector piece of the container and / or to the first flexible film and the second flexible film of the container. As before, the configuration of the protection cover is based on the finding that the connection interface is the principal point of connection of the at least one product chamber of an associated container and an environment comprising oxygen and / or carbon dioxide. In other words, it has been found that a potential deterioration of the medicinal and / or nutritional product in the at least one product chamber of the associated container is mainly due to the ingress of oxygen and / or carbon dioxide which happens via theconnection interface. This phenomenon may be reliably suppressed using the protection cover enclosing the at least one connection interface. Thus, in contrast to the known overwrapping as described above, the protection cover does not enclose the entire container but only the critical portion thereof, i.e. the connection interface. Consequently, the protection cover may be comparatively small. Thus, the protection cover requires less material than a full overwrapping and, thereby, renders the container compact. Still, the at least one product chamber may be efficiently and effectively protected from the ingress of oxygen and / or carbon dioxide. Furthermore, the present configuration of the protection cover is advantageous with respect to a full overwrapping in that keeping the major portions of the associated container free from overwrapping allows to have a better heat distribution during potential sterilization steps. Furthermore, an outer surface of the first flexible film and the second flexible film is kept accessible, e.g. for printing a label thereon.
[0027] Due to the fact that, according to the present invention, the protection cover is configured to essentially cover a portion of the connector piece which comprises the connection interface, the protection cover is small as compared to the product chamber of an associated container. In an example, in which a height direction of the associated container is defined by a direction extending between a hanger interface of the container and the connector piece, a height of the protection cover may be 30 % or less of a height of the product chamber. Preferably, the height of the protection cover may be 25 % or less of a height of the product chamber. Further preferably, the height of the protection cover may be 20 % or less of a height of the product chamber. According to another example, a height of the protection cover is smaller than 300% of a height of the connector piece. Preferably, a height of the protection cover is smaller than 250% of a height of the connector piece. Further preferably, a height of the protection cover is smaller than 200% of a height of the connector piece.
[0028] According to an example, the protection cover comprises a flexible film. Thus, the protection cover is comparatively light and compact. Furthermore, the protection cover may be easily installed and withdrawn from the remaining components of the container. In thiscontext, the oxygen barrier and / or the carbon dioxide barrier may form part of the flexible film, e.g. if the flexible film is formed as a multi-layer film.
[0029] The flexible film of the protection cover may comprise polypropylene, polyethylene terephthalate, silicon oxide, and / or any other suitable material. In an example, the flexible film comprises two layers, wherein one layer comprises polypropylene and the other layer comprises silicon oxide. In another example, the flexible film comprises two layers, wherein one layer comprises polyethylene terephthalate and the other layer comprises silicon oxide. In still another example, the flexible film comprises four layers, wherein the two outer layers comprise polypropylene and one of the two layers in between these outer layers comprises polyethylene terephthalate and the other layer in between these outer layers comprises silicon oxide.
[0030] According to a variant, the protection cover comprises a third flexible film and a fourth flexible film. The third flexible film and the fourth flexible film are located on top of each other, wherein a space for the at least one connection interface is delimited by the mutually opposite sides of the third flexible film and the fourth flexible film and by a seam locally connecting the third flexible film and the fourth flexible film. In this context, the protection cover may be called a bag which is made from the third flexible film and the fourth flexible film. The seam locally connecting the third flexible film, and the fourth flexible film may be a permanent seam. In this case, the protection cover needs to be withdrawn as a whole in order to access the connection interface. Alternatively, the seam locally connecting the third flexible film, and the fourth flexible film may be a rupturable or peelable seam. In this case, the connection interface may be rendered accessible by separating the third flexible film and the fourth flexible film in that the rupturable or peelable seam is opened. All of these alternatives form a good compromise between reliable protection of the connection interface and comparatively easy accessibility, if needed.
[0031] According to another variant, the flexible film of the protection cover is folded such that a first portion of the flexible film and a second portion of the flexible film are located on top of each other, wherein a space for the at least one connection interface is delimited by themutually opposite portions of the flexible film and by a seam locally connecting the portions of the flexible film. Also in this context, the protection cover may be called a bag. However, in contrast to the afore-mentioned example, the protection cover is made from one single flexible film only which is folded. The seam locally connecting the portions of the flexible film may be a permanent seam. In this case, the protection cover needs to be withdrawn as a whole in order to access the connection interface. Alternatively, the seam locally connecting the portions of the flexible film may be a rupturable or peelable seam. In this case, the connection interface may be rendered accessible by separating the portions of the flexible film in that the rupturable or peelable seam is opened. All of these alternatives form a good compromise between reliable protection of the connection interface and comparatively easy accessibility, if needed.
[0032] According to still another variant, the protection cover is formed by a protection portion of the first flexible film and / or a protection portion of the second flexible film. A space for the at least one connection interface is delimited by the protection portion of the first flexible film and / or the protection portion of the second flexible film and by a seam locally connecting the protection portion of the first flexible film and / or the protection portion of the second flexible film. This covers three alternatives. In a first alternative, the protection cover is formed by a protection portion of the first flexible film. In this context, the protection portion may be folded such that a first portion of the protection portion and a second portion of the protection portion are located on top of each other, wherein a space for the at least one connection interface is delimited by the mutually opposite portions of the protection portion and by a seam locally connecting the portions of the protection portion. In a second alternative, the protection cover is formed by a protection portion of the second flexible film. In this context, the protection portion may be folded such that a first portion of the protection portion and a second portion of the protection portion are located on top of each other, wherein a space for the at least one connection interface is delimited by the mutually opposite portions of the protection portion and by a seam locally connecting the portions of the protection portion. In a third alternative, the protection cover is formed by a protection portionof the first flexible film and by a protection portion of the second flexible film. In this context, the space for the at least one connection interface may be delimited by the two protection portions and by a seam locally connecting the protection portions. As has been explained before, the seams can be permanent seams or rupturable or peelable seams. A configuration in which the protection cover is formed by a protection portion of the first flexible film and / or a protection portion of the second flexible film is advantageous in that the protection cover for the connection interface is integrally formed with the first flexible film and the second flexible film. This renders the associated container structurally simple and compact.
[0033] According to a third aspect of the present invention, there is provided a method for manufacturing a container according to the present invention. The method comprises providing the first flexible film and the second flexible film. The first flexible film and the second flexible film are located on top of each other, wherein a product chamber for the medicinal and / or nutritional product is delimited by the mutually opposite sides of the first flexible film and the second flexible film and by a seam locally connecting the first flexible film and the second flexible film. A connector piece is partially interposed between the first flexible film and the second flexible film and partially extends from the product chamber, wherein the connector piece is connected to the first flexible film and the second flexible film, and wherein the connector piece comprises at least one connection interface for withdrawing the medicinal and / or nutritional product from the product chamber. The at least one connection interface is arranged on the portion extending from the product chamber.Furthermore, the method comprises providing a protection cover as a component separate from the first flexible film, the second flexible film and the connector piece or providing a protection cover formed by a protection portion of the first flexible film and / or a protection portion of the second flexible film. Furthermore, the method comprises enclosing the at least one connection interface using the protection cover.
[0034] This method is based on the finding that the connection interface is the principal point of connection of the at least one product chamber and an environment comprising oxygen and / or carbon dioxide. In other words, it has been found that a potential deterioration of themedicinal and / or nutritional product in the at least one product chamber is mainly due to the ingress of oxygen and / or carbon dioxide which happens via the connection interface. This phenomenon may be reliably suppressed using the protection cover enclosing the at least one connection interface. Thus, in contrast to the known overwrapping as described above, the protection cover does not enclose the entire container but only the critical portion thereof. Consequently, the protection cover may be comparatively small. Thus, the protection cover requires less material than a full overwrapping and, thereby, renders the container compact. Moreover, applying the protection cover is comparatively easy. Still, the at least one product chamber may be efficiently and effectively protected from the ingress of oxygen and / or carbon dioxide. Furthermore, the present method is advantageous with respect to a full overwrapping in that keeping the major portions of the container free from overwrapping allows to have a better heat distribution during potential sterilization steps. Furthermore, an outer surface of the first flexible film and the second flexible film is kept accessible, e.g. for printing a label thereon.
[0035] According to an example, the method further comprises connecting the protection cover to the connector piece and / or to the first flexible film and the second flexible film. For example, the protection cover can be welded or adhesively connected to the first flexible film and / or to the second flexible. In case the protection cover is welded to the first flexible film and / or the second flexible film, the weld seam may be permanent or rupturable.Consequently, the protection cover is reliably connected to the first flexible film as the short the second flexible film, thereby reliably enclosing the connection interface.
[0036] In another example, the method further comprises arranging an oxygen absorber and / or an oxygen indicator inside the protection cover. In this context, an oxygen absorber is a device or material configured to absorb oxygen. Consequently, the storage life of the container may be even further enhanced, since oxygen is withheld from the at least one product chamber. An oxygen indicator is understood as a device or material that is configured to indicate the presence of oxygen. Consequently, using an oxygen indicator that is arranged inside the protection cover, offers the possibility to know whether oxygen is present inside theprotection cover and / or an amount of oxygen present inside the protection cover. This allows to draw conclusions on the remaining storage life of the container.
[0037] In still another example, the method further comprises arranging an identification device and / or an information carrier inside the protection cover. Using the identification device and / or the information carrier, and information on identity of the container and / or information describing the container may be provided to a user of the container in a simple and reliable manner. An example of an identification device is an RFID tag. In a simple case, the information carrier may be a leaflet.
[0038] The method may also comprise eliminating ambient air from the protection cover. Since the year comprises oxygen and a side, is enhances storage life of the medicinal and / or nutritional product in the at least one product chamber. In an example, the ambient air is eliminated from the protection cover by squeezing the protection cover.
[0039] It should be noted that the above examples may be combined with each other irrespective of the aspect involved.
[0040] These and other aspects of the present disclosure will become apparent from and elucidated with reference to the examples described hereinafter.BRIEF DESCRIPTION OF DRAWINGS
[0041] Examples of the disclosure will be described in the following with reference to the following drawings.Figure 1 shows a container for parenterally delivering a medicinal and / or nutritional product according to a first example of the present invention, wherein the container comprises a protection cover according to a first example of the invention, and wherein the container is manufactured using a method according to the present invention,Figure 2 shows a container for parenterally delivering a medicinal and / or nutritional product according to a second example of the present invention, wherein the container comprises a protection cover according to a second example of theinvention, and wherein the container is manufactured using a method according to the present invention,Figure 3 shows a container for parenterally delivering a medicinal and / or nutritional product according to a third example of the present invention, wherein the container comprises a protection cover according to a third example of the invention, and wherein the container is manufactured using a method according to the present invention,Figure 4 shows a container for parenterally delivering a medicinal and / or nutritional product according to a fourth example of the present invention, wherein the container comprises a protection cover according to a fourth example of the invention, and wherein the container is manufactured using a method according to the present invention,Figure 5 shows a container for parenterally delivering a medicinal and / or nutritional product according to a fifth example of the present invention, wherein the container comprises a protection cover according to a fifth example of the invention, and wherein the container is manufactured using a method according to the present invention,Figure 6 shows a container for parenterally delivering a medicinal and / or nutritional product according to a sixth example of the present invention, wherein the container comprises a protection cover according to a sixth example of the invention, and wherein the container is manufactured using a method according to the present invention, andFigure 7 shows a container for parenterally delivering a medicinal and / or nutritional product according to a seventh example of the present invention, wherein the container comprises a protection cover according to a seventh example of the invention, and wherein the container is manufactured using a method according to the present invention.DETAILED DESCRIPTION
[0042] The Figures are merely schematic representations and serve only to illustrate examples of the disclosure. Identical or equivalent elements are in principle provided with the same reference signs.
[0043] Figure 1 shows a container 10 which in the present example is used as a three-chamber parenteral nutrition bag. The container 10 may be used for a liquid or pulpy product.However, the container 10 is represented empty.
[0044] The container 10 comprises a first flexible film 12 and a second flexible film 14 which are placed on top of each other. In the representation of Figure 1, the lower flexible film is considered to be the first flexible film 12 and the upper flexible film is considered to be the second flexible film 14.
[0045] A product chamber 16 of the container 10 is delimited by the mutually opposite sides of the first flexible film 12 and the second flexible film 14 and a circumferentially closed seam 18 which in the present example is a weld seam.
[0046] Since in the example of Figure 1, the bag component 10 is empty, the mutually opposite sides of the first plastic film 12 and the second plastic film 14 contact each other.
[0047] Due to the fact that the container 10 is a three-chamber parenteral nutrition bag, the product chamber 16 may be subdivided into a first product chamber 16a, a second product chamber 16b, and a third product chamber 16c. Thus, the container comprises a total of three product chambers.
[0048] More precisely, an upper product chamber 16a is delimited with respect to a middle product chamber 16b by a permanent inner seam 20. Additionally, the upper product chamber 16a is delimited with respect to a lower product chamber 16c by a first rupturable inner seam 22. Moreover, the middle product chamber 16b is delimited with respect to the lower product chamber 16c by a second rupturable inner seam 24. It is noted that alternatively to the permanent inner seam 20, it is also possible to provide a rupturable seam. However, then this rupturable seam needs to be configured such that it requires substantially more power, forceor pressure to be ruptured than the first rupturable inner seam 22 and the second rupturable inner seam 24.
[0049] The container 10 additionally comprises a connector piece 26. The connector piece 26 is partially interposed between the first flexible film 12 and the second flexible film 14. This portion of the connector piece is connected to the first flexible film 12 to the second flexible film 14 via an associated weld seam. This connection is permanent.
[0050] Another portion of the connector piece 26 extends from the product chamber 16. This means that this portion of the connector piece 26 sticks out from the seam 18. This portion comprises a connection interface 28 configured for withdrawing the medicinal and / or nutritional product from the product chamber 16.
[0051] In the example of Figure 1, the connection interface 28 is formed as a twin port.
[0052] The container 10 additionally comprises a protection cover 30.
[0053] In the example of Figure 1, the protection cover 30 comprises a third flexible film 32 a fourth flexible film 34. Both the third flexible film 32 and the fourth flexible film 34 comprise an oxygen barrier and a carbon dioxide barrier.
[0054] The third flexible film 32 and the fourth flexible film 34 are located on top of each other.
[0055] Moreover, a space 36 for the connection interface 28 is delimited by the mutually opposite sides of the third flexible film 32 and the fourth flexible film 34 and by a seam 38 locally connecting the third flexible film 32 and the fourth flexible film 34.
[0056] In the example of Figure 1, the seam 38 is a rupturable or peelable seam.
[0057] Thus, in other words, the connection interface 28 is received inside the space 36 of the protection cover 30. Still in other words, the connection interface 28 is enclosed by the protection cover 30.
[0058] Moreover, the protection cover 30 is connected to the connector piece 26 via a weld 40. This weld is located at a mounting interface 41 of the protection cover 30.
[0059] Consequently, the space 36 for the connection interface 28 is completely separated from an environment of the container 10, thereby inhibiting oxygen and carbon dioxide fromentering space 36.
[0060] It is noted that alternatively to connecting the protection cover 30 to the connector piece 26, the protection cover 30 may be connected to the first flexible film 12 and the second flexible film 14. The above-mentioned effect is the same.
[0061] According to a non-represented option, an oxygen absorber and / or an oxygen indicator may be arranged inside the protection cover 30.
[0062] Figure 2 shows a second example of the container 10. In the following, only the differences with respect to the example of Figure 1 will be explained. Otherwise, the above explanations apply mutatis mutandis.
[0063] The protection cover 30 of the example of Figure 2 differs from the protection cover 30 of the example of figure 1 in that the protection cover 30 of Figure 2 is formed by a single flexible film which will be referred to as a third flexible film 32.
[0064] This flexible film, i.e. the third flexible film 32 is folded such that a first portion 32a of the flexible film 32 and a second portion 32b of the flexible film are located on top of each other. Thus, the space 36 for the connection interface 28 is delimited by the mutually opposite portions 32a ,32b of the flexible film 32 and by a seam 38 locally connecting the portions of the flexible film 32. More precisely, the seam 38 is formed by two seam portions 38a, 38b in the example of Figure 2.
[0065] Figure 3 shows a third example of the container 10. In the following, only the differences with respect to the example of Figures 1 and 2 will be explained. Otherwise, the above explanations apply mutatis mutandis.
[0066] In contrast to the examples of Figures 1 and 2, the protection cover 30 of the example of Figure 3 is formed by a protection portion 42 of the first flexible film 12 and a protection portion 44 of the second flexible film 14.
[0067] The space 36 for the connection interface 28 is delimited by the protection portion 42 of the first flexible film 12 and the protection portion 44 of the second flexible film 14 and by a seam 38 locally connecting the protection portion 42 of the first flexible film 12 and the protection portion 44 of the second flexible film 14.
[0068] In simplified words, the protection cover 30 of the examples of Figure 1 and 2 is made by one or more flexible films 32, 34 being separate from the first flexible film 12 at the second flexible film 14. In contrast thereto, in the example of Figure 3, the protection cover 30 is formed by the first flexible film 12 and the second flexible film 14. Consequently, in the example of Figure 3, there is no need to provide flexible films beyond the first flexible film 12 and the second flexible film 14.
[0069] Moreover, in the example of Figure 3, the seam 38 is a rupturable or peelable seam such that this seam 38 can be opened for accessing the connection interface 28. According to an alternative, it is also possible to provide the protection cover 30 with a tear-off feature 46 which delimits the protection portion 42 of the first flexible film 12 and the protection portion 44 of the second flexible film 14 from the remaining portions of the first flexible film 12 and the second flexible film 14.
[0070] Consequently, in this alternative, the protection cover 30 may be separated from the remaining portions of the first flexible film 12 and the second flexible film 14 via the tear-off feature 46. In Figure 3 this tear-off feature 46 is illustrated by a dashed line. However, it is understood that it is sufficient to either have the tear-off feature 46 or a rupturable or peelable seam 38.
[0071] It is noted that generally all types of tear-off features 46, i.e. locally weakened portions of the first flexible film 12 and the second flexible film 14, may be used. However, since the protection cover 30 may comprise an oxygen barrier and a carbon dioxide barrier, tear-off features 46 are preferred which are compatible with an intact oxygen barrier and an intact carbon dioxide barrier. In more detail, it is possible that the tear-off features 46 comprise local perforations of the first flexible film 12 and the second flexible film 14. However, these local perforations should not be provided in the oxygen barrier and in the carbon dioxide barrier.
[0072] Figure 4 shows a fourth example of the container 10. In the following, only the differences with respect to the above-described examples will be explained. Otherwise, the above explanations apply mutatis mutandis.
[0073] The protection cover 30 of the example of Figure 4 is formed by a protection portion42 of the first flexible film 12 only.
[0074] To this end, the protection portion 42 is folded such that a first portion 42a of the protection portion and a second portion 42b of the protection portion 42 are located on top of each other. Consequently, the space 36 for the connection interface 28 is delimited by the mutually opposite portions 42a, 42b of the protection portion 42 and by the seam 38 locally connecting the portions of the protection portion 42. More precisely, the seam 38 is formed by two seam portions 38a, 38b in the example of Figure 4.
[0075] It is noted that in another, non-represented alternative, the protection cover 30 may be formed by a protection portion 44 of the second flexible film 14 only. In this case, the protection portion 44 is folded such that a first portion of the protection portion 44 and a second portion of the protection portion 44 are located on top of each other. Consequently, the space 36 for the connection interface 28 is delimited by the mutually opposite portions of the protection portion 44 and by the seam 38 locally connecting the portions of the protection portion.
[0076] Figure 5 shows a fifth example of the container 10. In the following, only the differences with respect to the previous examples will be explained. Otherwise, the above explanations apply mutatis mutandis. In particular, the example of Figure 5 may be regarded as a variant of the example of Figure 3.
[0077] Thus, as in the example of Figure 3, the protection cover 30 is formed by a protection portion 42 of the first flexible film 12 and a protection portion 44 of the second flexible film 14. Moreover, the space 36 for the connection interface 28 is delimited by the protection portion 42 of the first flexible film 12 and the protection portion 44 of the second flexible film 14 and by a seam 38 locally connecting the protection portion 42 of the first flexible film 12 and the protection portion 44 of the second flexible film 14. The seam 38 is a rupturable or peelable seam such that this seam 38 can be opened for accessing the connection interface 28.
[0078] Also, the protection cover 30 is provided with a tear-off feature 46 which delimits the protection portion 42 of the first flexible film 12 and the protection portion 44 of the second flexible film 14 from the remaining portions of the first flexible film 12 and the secondflexible film 14.
[0079] Consequently, the protection cover 30 may be separated from the remaining portions of the first flexible film 12 and the second flexible film 14 via the tear-off feature 46. In Figure 5 this tear-off feature 46 is illustrated by a dashed line. In contrast to the example of Figure 3, the tear-off feature 46 in the example of Figure 5 is formed by two portions 46a, 46b which are separated by a gap. This gap is provided in the vicinity of the connector piece 26. In other words, the tear-off feature 46 is interrupted in the location where the protection portion 42 and the protection portion 44 cover the connector piece.
[0080] Moreover, in the example of Figure 5, the portions 46a, 46b of the tear-off feature 46 are provided within a weld seam 48. This weld seam 48 seals the first flexible film 12 and the second flexible film 14. Consequently, the tear-off feature 46 of the example of Figure 5 is particularly tight even though local perforations of the first flexible film 12 and the second flexible film 14 forming the tear-off feature 46 may extend over the full thickness of the first flexible film 12 and the second flexible film 14, i.e. also go through the oxygen barrier and the carbon dioxide barrier.
[0081] It is understood that it is sufficient to either have the tear-off feature 46 or a rupturable or peelable seam 38.
[0082] Figure 6 shows a sixth example of the container 10. In the following, only the differences with respect to the previous examples will be explained. Otherwise, the above explanations apply mutatis mutandis. In particular, the example of Figure 6 may be regarded as a variant of the example of Figure 3 or the example of Figure 5.
[0083] Thus, as in the example of Figures 3 and 5, the protection cover 30 is formed by a protection portion 42 of the first flexible film 12 and a protection portion 44 of the second flexible film 14. Moreover, the space 36 for the connection interface 28 is delimited by the protection portion 42 of the first flexible film 12 and the protection portion 44 of the second flexible film 14 and by a seam 38 locally connecting the protection portion 42 of the first flexible film 12 and the protection portion 44 of the second flexible film 14.
[0084] The seam 38 may be a rupturable or peelable seam or a permanent seam.
[0085] Also, the protection cover 30 is provided with a tear-off feature 46. However, the tear-off feature 46 is different from the previous examples.
[0086] In the example of Figure 6, the tear-off feature 46 comprises two comparatively small cuts in opposite edges of the protection cover 30. These cuts may be regarded as portions 46a, 46b of the tear-off feature 46. Both cuts serve as a starting point when tearing of a portion of the protection cover 30 in order to access the connection interface 28.
[0087] In order to ensure tightness with respect to oxygen and carbon dioxide, the cuts forming the portions 46a, 46b of the tear-off feature 46 are located adjacent to curved sections of the seam 38. In other words, the seam 38 is locally curved such that it goes around the cuts forming the portions 46a, 46b of the tear-off feature 46.
[0088] Figure 7 shows a seventh example of the container 10. In the following, only the differences with respect to the previous examples will be explained. Otherwise, the above explanations apply mutatis mutandis. In particular, the example of Figure 7 may be regarded as a variant of the example of Figure 5.
[0089] Thus, as in the example of Figure 5, the protection cover 30 is formed by a protection portion 42 of the first flexible film 12 and a protection portion 44 of the second flexible film 14. Moreover, the space 36 for the connection interface 28 is delimited by the protection portion 42 of the first flexible film 12 and the protection portion 44 of the second flexible film 14 and by a seam 38 locally connecting the protection portion 42 of the first flexible film 12 and the protection portion 44 of the second flexible film 14.
[0090] The seam 38 may be a rupturable or peelable seam.
[0091] The differences between the example of Figure 5 and the example of Figure 7 relate to the tear-off feature 46. Also in the example of Figure 7, the tear-off feature 46 is formed by two portions 46a, 46b which hare located on both sides of the connector piece 26. Both portions 46a, 46b comprise a local perforation which is located inside an associated weld seam 48 that renders the tear-off feature 46 tight.
[0092] However, in contrast to the example of Figure 5, each portion 46a 46b of the tear-off feature is essentially formed by two line-shaped segments that arranged at an angle. One ofthese segments extends substantially transverse to a withdrawal direction of the connection interface 28 and one of these segments extends substantially in parallel to the withdrawal direction. In simplified words, each portion 46a, 46b may be used for tearing of a comer of the protection cover 30. The remaining portions of the protection cover 30 may be moved to the side, opened by opening the seam 38 or torn off without the use of a tear-off feature 46 for accessing the connection interface 28.
[0093] In the example of Figure 7, the portions 46a, 46b of the tear-off feature 46 also create locations 50 adjacent to the corners of the protection cover which may be used to provide a documentation element or an information element, e.g. a piece of paper or cardboard. The information element or documentation element may be used for describing a feature of at least one of the products provided in the container 10.
[0094] In the following, a method for manufacturing a container 10 is explained. This method is suitable for manufacturing all of the above-described examples.
[0095] In a first step SI, the first flexible film 12 and the second flexible film 14 are provided. As has been explained before, the first flexible film 12 and the second flexible film 14 are located on top of each other such that the product chamber 16 for the medicinal and / or nutritional product is delimited by the mutually opposite sides of the first flexible film 12 and the second flexible film 14 and by the seam 18 locally connecting the first flexible film 12 and the second flexible film 14. The connector piece 26 is partially interposed between the first flexible film 12 and the second flexible film 14 and partially extends from the product chamber 16. The connector piece 26 is connected to the first flexible film 12 and the second flexible film 14. Moreover, the connector piece 26 comprises the connection interface 28 for withdrawing the medicinal and / or nutritional product from the product chamber 16. This connection interface 28 is arranged on the portion of the connector piece 26 extending from the product chamber 16.
[0096] In a second step S2, the protection cover 30 is provided.
[0097] In a first alternative of step S2, the protection cover 30 is provided as a component separate from the first flexible film 12, the second flexible film 14 and the connector piece 26.This alternative of step S2 is used for manufacturing the container 10 of Figures 1 and 2.
[0098] In a second alternative of step S2, the protection cover 30 is provided in the form of a protection portion 42 of the first flexible film 12 and / or a protection portion 44 of the second flexible film 14. This alternative of step S2 is used for manufacturing the container 10 of Figures 3 to 7.
[0099] In a third step S3, the connection interface 28 is enclosed using the protection cover 30.
[0100] In this context, the protection cover 30 may be connected to the connector piece 26 and / or to the first flexible film 12 and the second flexible film 14. However, this is only relevant if the protection cover 30 is provided as a separate component.
[0101] Optionally, an oxygen absorber and / or an oxygen indicator may be arranged inside the protection cover.
[0102] Further optionally, ambient air may be eliminated from the protection cover 30, e.g. by squeezing the protection cover.
[0103] It is noted that even though the protection cover 30 has been explained in connection with different examples of containers 10 being three-chamber parenteral nutrition bags, it is also possible to use the protection cover 30 in connection with other containers, e.g. nutrition bags having more or less than three chambers or containers for applications different from nutrition.
[0104] As used herein, the phrase “at least one,” in reference to a list of one or more entities should be understood to mean at least one entity selected from any one or more of the entities in the list of entities, but not necessarily including at least one of each and every entity specifically listed within the list of entities and not excluding any combinations of entities in the list of entities. This definition also allows that entities may optionally be present other than the entities specifically identified within the list of entities to which the phrase “at least one” refers, whether related or unrelated to those entities specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and / or B”) may refer, in one embodiment, to at least one,optionally including more than one, A, with no B present (and optionally including entities other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including entities other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other entities). In other words, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” may mean A alone, B alone, C alone, A and B together, A and C together, B and C together, A, B, and C together, and optionally any of the above in combination with at least one other entity.
[0105] Other variations to the disclosed examples can be understood and effected by those skilled in the art in practicing the claimed disclosure, from the study of the drawings, the disclosure, and the appended claims. In the claims the word “comprising” does not exclude other elements or steps and the indefinite article “a” or “an” does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope of the claims.
[0106] LIST OF REFERENCE SIGNS10 container12 first flexible film14 second flexible film16 product chamber16a first product chamber, upper product chamber 16b second product chamber, middle product chamber 16c third product chamber, lower product chamber 18 seam20 permanent inner seam22 first rupturable inner seam24 second rupturable inner seam26 connector piece28 connection interface30 protection cover32 third flexible film32a first portion of the third flexible film32b second portion of the third flexible film34 fourth flexible film36 space for the connection interface38 seam38a seam portion38b seam portion40 weld41 mounting interface of the protection cover42 protection portion of the first flexible film42a first portion of the protection portion42b second portion of the protection portionprotection portion of the second flexible film tear-off featureweld seamlocationfirst stepsecond stepthird step
Claims
CLAIMS1. A container (10) for parenterally delivering a medicinal and / or nutritional product, comprisinga first flexible film (12) and a second flexible film (14), the first flexible film (12) and the second flexible film (14) being located on top of each other, wherein at least one product chamber (16) for the medicinal and / or nutritional product is delimited by the mutually opposite sides of the first flexible film (12) and the second flexible film (14) and by a seam (18) locally connecting the first flexible film (12) and the second flexible film (14),a connector piece (26) partially interposed between the first flexible film (12) and the second flexible film (14) and partially extending from the product chamber (16), wherein the connector piece (26) is connected to the first flexible film (12) and the second flexible film (14), and wherein the connector piece (26) comprises at least one connection interface (28) for withdrawing the medicinal and / or nutritional product from the product chamber (16), wherein the at least one connection interface (28) is arranged on the portion extending from the product chamber (16), anda protection cover (30) enclosing the at least one connection interface (28), wherein the protection cover (30) comprises an oxygen barrier and / or a carbon dioxide barrier.
2. The container (10) of claim 1, wherein the protection cover (30) comprises a flexible film (12, 14, 32, 34).
3. The container (10) of claim 2, wherein the protection cover (30) comprises a third flexible film (32) and a fourth flexible film (34), the third flexible film (32) and the fourth flexible film (34) being located on top of each other, wherein a space (36) for the at least one connection interface (28) is delimited by the mutually opposite sides of the third flexible film (32) and the fourth flexible film (34) and by a seam (38) locally connecting the third flexible film (32) and the fourth flexible film (34).
4. The container (10) of claim 2, wherein the flexible film (12, 14, 32, 34) is folded such that a first portion (32a) of the flexible film (12, 14, 32, 34) and a second portion (32b) of the flexible film (12, 14, 32, 34) are located on top of each other, wherein a space (36) for the at least one connection interface (28) is delimited by the mutually opposite portions (32a, 32b) of the flexible film (12, 14, 32, 34) and by a seam (38) locally connecting the portions (32a, 32b) of the flexible film (12, 14, 32, 34).
5. The container (10) of claim 1 or 2, wherein the protection cover (30) is formed by a protection portion (42) of the first flexible film (12) and / or a protection portion (44) of the second flexible film (14), wherein a space (36) for the at least one connection interface (28) is delimited by the protection portion (42) of the first flexible film (12) and / or the protection portion (44) of the second flexible film (14) and by a seam (38) locally connecting the protection portion (42) of the first flexible film (12) and / or the protection portion (44) of the second flexible film (14).
6. The container (10) of claim 5, wherein the protection portion (42) of the first flexible film (12) is delimited from the remaining portions of the first flexible (12) film by a tear-off feature (46) and / or wherein the protection portion (44) of the second flexible film (14) is delimited from the remaining portions of the second flexible film (14) by a tear-off feature (46).
7. The container (10) of any one of the preceding claims, wherein the protection cover (30) is connected to the connector piece (26).
8. The container (10) of any one of the preceding claims, wherein the protection cover (30) is connected to the first flexible film (12) and / or to the second flexible film (14).
9. The container (10) of any one of the preceding claims, wherein an oxygen absorber and / or an oxygen indicator is arranged inside the protection cover (30).
10. A protection cover (30) for a container (10) of any one of the preceding claims, the protection cover (30) comprising a space (36) for the at least one connection interfacecover (30) to the connector piece (26) of the container (10) and / or to the first flexible film (12) and the second flexible film (14) of the container (10).
11. A method for manufacturing a container (10) according to any one of claims 1 to 9, the method comprising:providing (SI) the first flexible film (12) and the second flexible film (14), the first flexible film (12) and the second flexible film (14) being located on top of each other, wherein a product chamber (16) for the medicinal and / or nutritional product is delimited by the mutually opposite sides of the first flexible film (12) and the second flexible film (14) and by a seam (18) locally connecting the first flexible film (12) and the second flexible film (14), and the connector piece (26) partially interposed between the first flexible film (12) and the second flexible film (14) and partially extending from the product chamber (16), wherein the connector piece (26) is connected to the first flexible film (12) and the second flexible film (14), and wherein the connector piece (26) comprises at least one connection interface (28) for withdrawing the medicinal and / or nutritional product from the product chamber (16), wherein the at least one connection interface (28) is arranged on the portion extending from the product chamber (16), providing (S2) a protection cover (30) as a component separate from the first flexible film (12), the second flexible film (14) and the connector piece (26) or providing a protection cover (30) formed by a protection portion (42) of the first flexible film (12) and / or a protection portion (44) of the second flexible film (14), andenclosing (S3) the at least one connection interface (28) using the protection cover (30).
12. The method of claim 11, further comprising connecting the protection cover (30) to the connector piece (26) and / or to the first flexible film (12) and the second flexible film (14).
13. The method of claim 11 or 12, further comprising arranging an oxygen absorber and / or an oxygen indicator inside the protection cover (30).
14. The method of any one of claims 11 to 13, further comprising arranging an identification device and / or an information carrier inside the protection cover (30).
15. The method of any one of claims 11 to 14, further comprising eliminating ambient air from the protection cover (30).