OPENING DEVICE FOR ASEPTIC CARTON PACKAGING USED FOR ENTERAL NUTRITION THROUGH CLOSED SYSTEM OR OPEN SYSTEM

Abstract

The present invention falls within the technical field of Food Packaging and was developed specifically to meet the needs of the Enteral Nutrition market. This innovation proposes a unique packaging solution, compatible with both Closed Enteral Systems and Open Enteral Systems. It is defined as an integrated opening device in the aseptic carton packaging, which allows direct connection to the enteral feeding set without the need for external devices (such as adapters and connectors). Thus, the invention transforms the conventional use of aseptic carton packagingpreviously limited to open enteral systemsinto a versatile, multi-use solution. Featuring characteristics equivalent to those of specialized packages for closed systems available in the market, this device, when incorporated into aseptic carton packaging, enables the contained product to be administered in both closed and open enteral systems. This is made possible by its features that allow direct connection to the enteral feeding set while provide the essential functionalities of traditional aseptic carton packaging, such as the rupture of the internal protective seal, which occurs when unscrewing the cap.

Claims

1. An opening device applied to an aseptic carton packaging used for enteral nutrition in either closed or open systems, the said device being provided with: a cap comprising a cylindrical body whose upper edge is joined to a closure region of the cap, a thread being provided on the inner region of the said cylindrical body, a sealing structure being provided on the inner face of the closure region of the said cylindrical body, a tamper-evident seal being provided on the lower edge of the cap, a structure formed by elements integrated orthogonally to the internal surface of the closure region of the said cylindrical body necessary to activate the cutting element located at the base; a base that comprises a lower element and an upper element, in which: the said lower element of the base has a body that is substantially flat in its upper region, while its lower region is capable of receiving an amount of adhesive required to adhere the said device to the said aseptic carton packaging; the said upper element of the base comprises a cylindrical body substantially orthogonal to the said lower element; the said cylindrical body of the base is provided with an external thread to enable the screwing of the thread of the cap to the base; and a cutting element activated by the component during the rotation of the cap in case the packaging is intended for an open enteral nutrition system; the said device being characterized by: an access device for connection of an enteral feeding set provided in the said closure region that is joined to the upper edge of the cylindrical body of the cap.

2. An opening device applied to an aseptic carton packaging used for enteral nutrition in either closed or open systems, the said device being provided with: a cap that comprises a cylindrical body whose upper edge is joined to a closure region of the cap, a thread being provided on the inner region of the said cylindrical body, a sealing structure being provided on the inner face of the closure region of the said cylindrical body; a base that comprises a lower element and an upper element, in which: the said lower element of the base comprises a body substantially flat in its upper region, while its lower region is capable of receiving an amount of adhesive required to adhere the said device to the said aseptic carton packaging; the said upper element of the base comprises a cylindrical body substantially orthogonal to the said lower element; and the said cylindrical body of the base is provided with an external thread to enable the screwing of the thread of the cap to the base; the said device being characterized by: an access device for connection of an enteral feeding set provided in the said closure region that is joined to the upper edge of the cylindrical body of the cap.

3. The opening device according to claim 1, characterized by a biological filter being additionally provided in the said closure region of the cap which is joined to the upper edge of the cylindrical body of the cap.

4. The opening device according to claim 2, characterized by a biological filter being additionally provided in the said closure region of the cap which is joined to the upper edge of the cylindrical body of the cap.

Description

DESCRIPTION OF THE DRAWINGS

[0046] The invention can be embodied in various layouts with alternative mechanisms and complementary components. Below is the description of the figures provided to illustrate the invention and some of its concepts:

[0047] FIG. 1 presents a photograph of a traditional aseptic carton packaging (E) with an automated opening device (D), as currently used in enteral products intended for administration in an open system. The image on the right side is a graphic representation of the same packaging (E) before the opening device (D) is incorporated, highlighting the weakened area (S) formed by the removal of the upper layers of plastic and cardboard.

[0048] FIGS. 2A to 2D present an opening device (T) of an aseptic carton packaging (E) equipped with: an access device (4) for the connection of standard ENFit enteral feeding sets, and an automated opening mechanism (1.1; 2.3).

[0049] FIG. 2A presents the top view of the cap (2) of the opening device (T).

[0050] FIG. 2B presents the bottom view of the cap (2) of the opening device (T).

[0051] FIG. 2C presents the opening device (T), as described in FIGS. 2A-2D, disassembled, showing all its parts before assembly.

[0052] FIG. 2D illustrates the opening device (T), as described in FIGS. 2A-2D, fully assembled, with all parts properly fitted.

[0053] FIGS. 3A to 3D present an opening device (T) of an aseptic carton packaging (E), equipped with an access device (4) for the connection of standard ENFit enteral feeding sets. In the packaging (E) that adopt this model of device (T), the removal of the internal protective seal (S), for use in an open system, is performed manually.

[0054] FIG. 3A presents the top view of the cap (2) of the opening device (T).

[0055] FIG. 3B presents the bottom view of the cap (2) of the opening device (T).

[0056] FIG. 3C presents the opening device (T), as described in FIGS. 3A-3D, disassembled, showing all its parts before assembly.

[0057] FIG. 3D illustrates the opening device (T), as described in FIGS. 3A-3D, fully assembled, with all parts properly fitted.

[0058] FIGS. 4A to 4D present an opening device (T) of an aseptic carton packaging (E) equipped with: an access device (5) for the connection of standard Spike enteral feeding sets; and an automated opening mechanism (1.1; 2.3).

[0059] FIG. 4A presents the top view of the cap (2) of the opening device (T).

[0060] FIG. 4B presents the bottom view of the cap (2) of the opening device (T).

[0061] FIG. 4C presents the opening device (T), as described in FIGS. 4A-4D, disassembled, showing all its parts before assembly.

[0062] FIG. 4D illustrates the opening device (T), as described in FIGS. 4A-4D, fully assembled, with all parts properly fitted.

[0063] FIGS. 5A to 5D present an opening device (T) of an aseptic carton packaging (E) equipped with an access device (5) for the connection of standard Spike enteral feeding sets. In packages (E) adopting this model of device (T), the removal of the internal protective seal (S) for use in an open system is performed manually.

[0064] FIG. 5A presents the top view of the cap (2) of the opening device (T).

[0065] FIG. 5B presents the bottom view of the cap (2) of the opening device (T).

[0066] FIG. 5C presents the opening device (T), as described in FIGS. 5A-5D, disassembled, showing all its parts before assembly.

[0067] FIG. 5D illustrates the opening device (T), as described in FIGS. 5A-5D, fully assembled, with all parts properly fitted.

[0068] FIG. 6 presents drawings of the cap (2) belonging to the opening device (T) provided with a microbiological filter (6).

[0069] The most important components for understanding and applying the present invention are described below: [0070] (E)Aseptic carton packagingnot part of the invention, but its identification is important to facilitate the descriptions. [0071] (S)Protective seal present in an aseptic carton packaging (E), comprising a circular region formed by the removal of the upper layers of plastic and cardboard to create an area less resistant to cutting by element 1.1. [0072] (D)Automated opening device (DAA), widely recognized and used in aseptic carton packaging (E)not part of the invention, but its identification is important to facilitate the descriptions. [0073] (C)Packaging system formed by an aseptic carton packaging (E) and an opening device (T; D; or TLAM). [0074] (T)This is the present invention, an opening device of an aseptic carton packaging (E) formed by a base (1) and a cap (2) provided with an access device (4; 5) for enteral feeding sets. [0075] (1)Base, the lower part of the opening device (T). [0076] (1.1)Cutting element positioned inside the spout (1.6) of the base (1). [0077] (1.2)Upper rim of the spout (1.6) of the base (1), designed to promote the hermetic sealing of the packaging (E) in synergy with the structure (2.4) of the cap (2). [0078] (1.3)Male thread surrounding the outer part of the spout (1.6) of the base (1) for securing the female thread (2.1) present on the inner part of the cylindrical body (2.5) that makes up the cap (2). [0079] (1.4)Structure provided at the lower part of the spout (1.6) of the base (1) for association with the tamper-evident seal (2.2) present on the cap (2) of the opening device (T). [0080] (1.5)Flat body comprising the lower element of the base (1), where the cylindrical body forming the spout (1.6) is provided orthogonally. [0081] (1.6)Cylindrical body comprising the upper element of the base (1), forming a spout with a male thread (1.3) corresponding to the female thread (2.1) provided inside the cap (2). [0082] (1.7)Region on the lower surface of the base (1) where the adhesive is applied to permanently fix the opening device (T) to the packaging (E). [0083] (2)Cap, the upper part of the opening device (T). [0084] (2.1)Female thread provided inside the cylindrical body (2.5) that makes up the cap (2) of the opening device (T), compatible with the male thread (1.3) surrounding the spout (1.6) of the base (1) of the same device (T). [0085] (2.2)Tamper-evident seal provided at the lower rim of the cap (2) of an opening device (T). When broken, it indicates that the packaging has been opened or tampered with and that the product is no longer eligible for administration in a closed system. [0086] (2.3)Structure formed by integrated elements orthogonally to the inner surface of the closing area (2.6) of the cylindrical body (2.5). Designed to promote a downward movement of the cutting element (1.1) of the base (1), simultaneously with the rotational movement of the cap (2) during the opening process of the packaging (E) through the opening device (T). [0087] (2.4)Circular structure provided on the inner face of the closing region (2.6) of the cap (2). Designed for continuous compression against the upper edge (1.2) of the spout (1.6), ensuring a hermetic seal both before and after breaking the seal (2.2) through precise threading. [0088] (2.5)Cylindrical body that makes up the cap (2) of an opening device (T). [0089] (2.6)Closing region provided at the upper rim of the cylindrical body (2.5) that makes up the cap (2) of an opening device (T). [0090] (3)Protrusions provided around the cylindrical body (2.5) that makes up the cap (2) for better finger grip during the opening of the device (T) when the product is intended for use in an open system. [0091] (4)Cylindrical body comprising the access device for connecting an ENFit set, provided in the closing region (2.6) of the cylindrical body (2.5) of the cap (2). [0092] (4.1)Male thread of the access device (4) corresponding to the female thread of an ENFit set. [0093] (4.2)Circular area located on the surface of the access device (4), where the compression of the sealing ring found in ENFit equipment occurs. This compression ensures that the coupling of the enteral set to the opening device (T) of a packaging (E) maintains a hermetic seal. [0094] (5)Cylindrical body comprising the access device for connecting a Spike set, provided in the closing region (2.6) of the cylindrical body (2.5) of the cap (2). The sealing structure of the Spike set is circumferentially compressed in the internal region of this device (5), ensuring a hermetic seal of the packaging. [0095] (5.1)Closing region at the lower edge of the access device (5), made with a thinner thickness, forming a weakened area to facilitate penetration by a Spike set. [0096] (6)Microbiological filter provided in the closing region (2.6) of the cylindrical body (2.5) of the cap (2), allowing air to enter to balance the internal pressure of the packaging (E).

DESCRIPTION OF THE INVENTION

[0097] For the purpose of interpreting the documents related to the patent application for this invention, the following definitions shall apply: where appropriate, terms used in the singular shall also include the plural and vice versa. In any situation of conflict between definitions set forth below and those present in other documents, including any documents potentially incorporated into the descriptive report, the definition here shall prevail for the purposes of interpreting the invention and attached claims, unless stated otherwise. Terms such as a or an associated with comprising or including in the claims and/or report may refer to a single item or multiple items. The term or in claims refers to and/or unless explicitly indicated otherwise. Words like comprising, having, including, or containing are inclusive in nature and do not exclude other steps or elements not mentioned. Those skilled in the art will understand that, in some contexts, comprising may be substituted by consisting essentially of and/or consisting of. The term about allows for a variation of up to 10% of the associated numerical value, unless another value is specified.

[0098] Regarding the description that follows, referring to an embodiment of the invention and to the attached drawings and possible examples, it serves to elucidate its principles. The embodiment details the invention sufficiently for those skilled in the art to reproduce it. Other embodiments are also possible, and structural, physical, and/or chemical changes may be made without deviating from the spirit and scope of the invention. Unless defined otherwise, all technical and scientific terms used in this report have meanings commonly understood by one skilled in the art.

[0099] Further to the description, the images or drawings attached do not represent a fixed specification and do not indicate any mode of industrial design registration for the invention. They are illustrative presentations, intended to facilitate the understanding of the concept of the invention. If, for example, an image of a mechanism from the prior art is used, it does not imply an exact representation of the mechanisms developed for the present invention, but rather a concrete example, widely recognized and used, to clarify the concept in question. It is important to emphasize that the prior art devices integrated into the present invention are those whose patent protection has already expired or are conceptually similar. However, the essence of the present invention can be harmonized with devices still under patent protection, provided that authorization is duly obtained from the holder of such rights.

[0100] For visualization purposes, terms such as upper, lower, vertical, and horizontal refer to positions in the Figures as depicted. Longitudinal and transverse refer to the viewing sequence, from top to bottom and from left to right, respectively. The term anterior should be related to what is visible in the Figure, and the term posterior should be related to what is on the opposite side of the Figure.

About the Concept of the Invention:

[0101] The invention relates to an opening device (T) composed of two parts: the base (1) and the cap (2). It is emphasized that this invention incorporates opening mechanisms similar to those widely used in opening devices (D) of aseptic carton packaging (E). In some embodiments, the base (1) provides an opening mechanism similar to the devices (D) currently available on the market, including a cutting element (1.1) in the models with an automated opening mechanism (FIGS. 2A-2D and 4A-4D). FIGS. 2A-2D and 4A-4D show that the cap (2) has an auxiliary structure (2.3) designed to rotate the cutting element (1.1) positioned inside the spout (1.6) of the base (1), giving the device (T) an automatic opening functionality. This functionality optionally facilitates the use of the product in an open enteral system, simply by unscrewing the cap (2) to open the packaging (E).

[0102] This model of the opening device (T) is permanently affixed to an aseptic carton package (E) during the manufacturing process of a product (C). As shown in FIGS. 2A-2D to 5A-5D, the device (T) can be materialized in various forms, either to fit the different types of sets available in the market, to facilitate production, or to improve the handling experience through more practical, comfortable, and safe models. Layouts of the device (T) were illustrated in models compatible with two types of enteral sets: ENFit standard (FIGS. 2A-2D and 3A-3D); Spike standard (FIGS. 4A-4D and 5A-5D). The various layouts can be produced with or without a microbiological filter (6).

[0103] An enteral product packaged in an aseptic carton package (E) equipped with an opening device (T) offers the possibility of administration in both open and closed enteral systems. This flexibility stems from the design of the opening device (T), which, in addition to mechanisms (2.1; 2.3) to facilitate access to the content for use in open systems, also integrates specific features (4; 5; 6) for administration in closed enteral systems: access device for the enteral feeding set (4 and 5); and a microbiological filter (6) that allows the entry of filtered air to balance the internal pressure of the package (E). Until now, such features (4; 5; 6) were known only in: external devices to enable the enteral administration of a product directly from its aseptic carton package (E); bottles for the administration of enteral formulas; and packaging specially developed for products intended for administration through a closed enteral system. Opening devices (T) without a microbiological filter (6) can be integrated into packages (E); however, these packages need to be prepared to become easily collapsible, maintaining satisfactory product flow during administration.

[0104] The inventive concept is broadly illustrated as an opening device (T) for aseptic carton packaging (E) with access for enteral feeding sets (4 and 5) in its cap (2). The opening device (T) consists of a base (1) and a cap (2). The cap (2) may contain an auxiliary structure (2.3) to rotate the cutting element (1.1) inside the base (1) in some models of the invention, in addition to a fitting for enteral feeding sets (4 and 5). In these models, the base (1) can be connected to the cap (2) by fitting the tamper-evident seal (2.2) to the structure (1.4) of the base (1). For use as an open system, the tamper-evident seal (2.2) is broken by unscrewing the cap (2) from the opening device (T) to open the packaging, breaking the internal seal (S) and allowing the content to be transferred to another container for oral use or in an open enteral system. In models without an automatic opening mechanism, the tamper-evident seal (2.2) becomes dispensable. This is because such packages preserve the integrity of the internal seal (S) or the manual opening seal even after unscrewing and subsequently removing the cap (2) from the spout (1.6) that forms the base (1).

About the Construction of the Invention:

[0105] The opening device (T) consists of two essential parts: the base (1) and the cap (2). Models that incorporate an automatic opening mechanism also include a third component: the cutting element (1.1) located internally at the spout (1.6) of the base (1). The production of these components can occur through the plastic injection process. In this procedure, thermoplastic resins such as polypropylene and polyethylene are heated until they become liquid and are then injected into precise molds under controlled pressure. For configurations where the base (1) is formed during the aseptic filling, the plastic injection technology is directly integrated into the filling machine, often used in packages (E) that use caps with a manual opening seal (TLAM).

[0106] To achieve the desired robustness and specificity, some parts may be derived from the combination of subparts. The union of these subparts can employ a range of techniques: from precise and irreversible fittings under compression to various welding methods such as hot welding (thermofusion), ultrasonic welding, vibration welding, laser welding, or any other method commonly used in the plastic industry.

[0107] Just as in caps for non-collapsible packaging for closed system enteral products, some embodiments of this opening device (T) are equipped with a microbiological filter (6). This filter (6) is essential in non-collapsible packaging because it ensures the entry of properly filtered air into the packaging, maintaining pressure balance and ensuring continuous flow during the infusion of the enteral product into the patient. The integration of this filter (6) into the closing region (2.5) of the base (2) of the opening device (T) can be achieved through plastic welding, adhering the filter (6) directly to the base (2) in a stable manner. Alternatively, the filter (6) can be interspersed between plastic parts that, when fitted under pressure, join irreversibly, or by other plastic welding methods previously mentioned.

[0108] After the molding and assembly stages, the parts are combined to form the opening device (T). In the conventional approach, the opening device (T) is already prepared to be attached to the packaging (E). However, in the method where the base (1) is molded during the filling process, the production phases occur at different times and places: independent manufacturing of the cap (2) by plastic injection; molding of the base (1) by the injector integrated into the aseptic filler; and the joining of the cap (2) to the base (1) already formed in the packaging (E). Precise methods such as fittings or threading ensure the perfect attachment of the opening device (T). Additional protection, such as an adhesive film or a removable plastic component, can be added to protect the connection area of the enteral feeding sets (4 and 5), providing an extra layer against dirt. The result is a solid and effective device (T) that ensures a hermetic and secure closure of the packaging (E).

[0109] It is important to highlight that for packaging equipped with opening devices without a microbiological filter (6), a specific procedure is required to ensure the effectiveness of the infusion. The carton packaging must be prepared to become easily collapsible. This is necessary to prevent the emergence of negative pressure inside the packaging as the content is drained during the infusion process. To achieve this adaptability, the ends of the packaging must be carefully unfolded, deconstructing both the upper and lower vertices. By performing this step, all the edges of the packaging become malleable. This structural modification undoes the original parallelepiped formation of the packaging, allowing it to easily yield and collapse as the content flows, ensuring a continuous and uninterrupted infusion, even in the absence of compensatory air intake.

EXAMPLES OF EMBODIMENTS OF THE INVENTION

[0110] Some examples of implementations of the invention are depicted in FIGS. 2A-2D to 5A-5D. Any embodiment can be produced with a microbiological filter (6), as illustrated in FIG. 6. However, due to the simplicity of its manufacture and the more affordable cost associated with spike sets, FIGS. 4A-4D illustrate the preferred approach for implementing the invention.

[0111] Most aseptic carton packaging (E) used in liquid foods features an opening device (D); however, none of the existing opening device models (D) in the prior art for aseptic carton packaging (E) provide means to connect an enteral feeding set, as is the case with the opening device (T). Therefore, the present invention (T) represents an innovative solution for the market, enabling aseptic carton packaging to be used in products qualified for administration in closed enteral systems.