Container for a miscible medical device and / or a miscible nutritional product

Abstract

A container (10) for a mixable medical product and / or a mixable nutritional product is described. The container (10) comprises a first flexible film (12) and a second flexible film (14). A product space (16) is delimited by opposite sides of the first flexible film (12) and the second flexible film (14) and by a circumferential seam (18). The product space (16) is subdivided into at least two product chambers (20a, 20b, 20c) by means of at least one dividing seam (22, 24, 26), wherein the at least one dividing seam (22, 24, 26) temporarily connects the first flexible film (12) and the second flexible film (14) locally and at least in sections. The at least one dividing seam (22, 24, 26) meets the circumferential seam (18) in a connecting zone (32).Outside the connection zone (32) at least one reinforcing element (34) is provided, which locally connects the first flexible film (12) and the second flexible film (14).

Description

[0001] The invention relates to a container for a mixable medical product and / or a mixable nutritional product. The container comprises a first flexible film and a second flexible film, which are arranged one on top of the other. A product space is delimited by opposite sides of the first flexible film and the second flexible film and by a circumferential seam that permanently and locally connects the first flexible film and the second flexible film. The product space is subdivided into at least two product chambers by means of at least one dividing seam, wherein the at least one dividing seam temporarily connects the first flexible film and the second flexible film locally and at least in sections.

[0002] Such containers are well known. Due to the fact that the first and second films are flexible, such containers are often referred to as bags.

[0003] Such containers are used when components of the mixable medical device and / or the mixable nutritional product are to be kept separate from one another during a storage phase. In such a case, each component can be provided in a product chamber. Since the product chambers are separated from one another by the at least one dividing seam, mixing of the components is avoided. This can have positive effects on storability. Furthermore, in such a container, the components can be selectively mixed by completely or partially dissolving the at least one dividing seam. This means that in the area of ​​the at least one dividing seam, the first flexible film and the second flexible film are no longer locally connected to one another, at least in sections.

[0004] In this context, the dividing seam can be completely or partially released, for example, by subjecting one or more of the components provided in an adjacent product chamber to mechanical pressure. This results in the adjacent dividing seam becoming loose or breaking, at least in sections. It is understood that the important thing in this case is to only release the section(s) of the dividing seam intended for this purpose. The remaining sections and seams, in particular the circumferential seam, should remain closed, i.e., continue to connect the first flexible film and the second flexible film.

[0005] This means that, on the one hand, such a container must be stable in the area of ​​the seams. On the other hand, the container must allow for the selective release of designated seams and / or seam sections. This is somewhat contradictory, since high stability is often associated with poor detachability, and vice versa.

[0006] The object of the present invention is therefore to resolve or at least mitigate this contradiction. The aim is to create a container that, thanks to stable seams, allows components of a mixable medical device and / or nutritional product to be reliably kept separate from one another. At the same time, this container should allow components of the medical device and / or nutritional product to be mixed in the desired manner.

[0007] The object is achieved by a container for a mixable medical product and / or a mixable nutritional product. The container comprises a first flexible film and a second flexible film, which are arranged one on top of the other. A product space is delimited by opposite sides of the first flexible film and the second flexible film and by a circumferential seam that permanently and locally connects the first flexible film and the second flexible film. The product space is subdivided into at least two product chambers by means of at least one dividing seam, wherein the at least one dividing seam temporarily connects the first flexible film and the second flexible film locally and at least in sections. The at least one dividing seam meets the circumferential seam in a connection zone.At least one reinforcing element is provided outside the connection zone, which locally connects the first flexible film and the second flexible film. The fact that the dividing seam temporarily connects the first flexible film and the second flexible film at least in sections means that at least a section of the dividing seam is intended to selectively release a connection between the first flexible film and the second flexible film, so that components of the medical device and / or the nutritional product provided in product chambers adjacent to this dividing seam can be mixed. In the connection zone, the circumferential seam, which is intended to reliably and permanently connect the first and second films, thus meets the dividing seam, which is intended to be detachable at least in sections.In this context, the reinforcing element increases the stability of the circumferential seam, so that the permanent connection of the circumferential seam is reliably maintained even in situations in which comparatively large mechanical forces and / or stresses act on the adjacent dividing seam. This can be the case, for example, while the dividing seam is being released by subjecting a component located in an adjacent product chamber to mechanical pressure. This prevents unwanted leaks resulting from the unwanted release of otherwise permanent connections. For this purpose, the reinforcing element can be arranged in an area of ​​the circumferential seam that is subject to particularly high loads when the dividing seam is released. Such an area of ​​the circumferential seam can be determined using empirical knowledge, simulation methods and / or tests.The reinforcing element does not affect the mechanical properties of the dividing seam, so that the intended sections of the dividing seam can be easily removed.

[0008] The reinforcing element also simplifies the manufacture of the container. This is because the reinforcing element locally connects the first flexible film and the second flexible film. In the region of the reinforcing element, the first flexible film and the second flexible film are thus connected to one another over a comparatively large area. This is particularly true compared to sections of the circumferential seam that lie outside the connection zone. This prevents the formation of folds in the first flexible film and / or in the second flexible film, which could otherwise arise or be created during the production of the circumferential seam and / or the at least one dividing seam. In this context, the creation of folds means that the container is converted into a configuration during production which later leads to the formation of folds, e.g. when the container is filled.This can happen in particular when transporting filled containers on a conveyor belt or when attaching outer packaging to the container. This is avoided here. In particular, the formation of so-called S / Z folds is avoided. In this context, folds usually represent undesirable mechanical weak points in the container. In other words, the use of the reinforcing element allows the mechanical stability with which the first film and the second film are held together in the area of ​​a seam to be specifically adjusted. This allows specific seam sections to be defined that can be undone by a user and other seam sections that are intended to permanently connect the first film and the second film.

[0009] The container, i.e., the first flexible film and / or the second flexible film, may be made of a polymer material. Such materials are particularly well-suited for the storage and administration of miscible medical devices and / or nutritional products. The polymer material may be multilayered.

[0010] Preferably, both the circumferential seam and the at least one dividing seam are weld seams.

[0011] In the context of the present invention, a temporary connection is understood to mean a detachable connection.

[0012] According to one variant, the reinforcing element is a flat seam segment. The reinforcing element is thus formed as a section of a seam, in particular the circumferential seam. The fact that the seam segment is flat is to be understood with reference to the remaining sections of the seam for which the reinforcing element is formed. A flat seam segment has a surface area, relative to a unit of length, that is larger than that of a remaining section of the same seam. In other words, the flat seam segment represents a thickened or widened seam segment. The surface area is preferably at least 25% larger. Such a reinforcing element can be realized comparatively easily and cost-effectively during the manufacture of the container.In addition, such a reinforcing element is comparatively compact, so that the product volume of the container is only slightly affected or not affected at all by the reinforcing element.

[0013] According to another variant, the reinforcing element is a seam segment that protrudes convexly toward the interior of the product space. In this context, a width of the seam segment that represents the reinforcing element can be equal to a width of the remaining segments of the seam. Alternatively, a width of the seam segment that represents the reinforcing element can be greater or smaller than a width of the remaining segments of the seam. The seam segment that represents the reinforcing element is, for example, curved. In this context, a reinforcing effect is achieved by the seam segment being convexly shaped toward the interior of the product space, thus preventing, for example, the undesirable formation of so-called S / Z folds.

[0014] According to one variant, the reinforcing element protrudes by at least 10 mm from the circumferential seam. In this context, when determining the distance by which the reinforcing element protrudes from the circumferential seam, the width of the circumferential seam is not taken into account. In other words, the width of the circumferential seam is not included in the measurement. This results in the container being particularly mechanically stable in the area of ​​the reinforcing element, in particular more stable than the circumferential seam itself. The protrusion of at least 10 mm ensures a minimum degree of stabilizing effect.

[0015] It is also possible for the at least one dividing seam to run diagonally in a use position of the container. In this context, a use position of the container refers to the spatial orientation of the container when the medical device and / or nutritional product, which may be provided in the container, is administered to a patient and / or customer. A diagonal course means that the dividing seam runs neither horizontally nor vertically. In a case in which the container is hung on a stand in the use position, a vertical direction usually runs from a mechanical interface via which the container is coupled to the stand to an end of the container opposite this mechanical interface, at which end an outlet for administering the medical device and / or nutritional product is usually provided.It has been found that by means of such an obliquely running dividing seam, a comparatively easy detachability of the intended sections of the dividing seam can be combined with a high mechanical stability of the remaining seams, in particular the circumferential seam.

[0016] The at least one dividing seam can be inclined by 0 to 60 degrees, preferably by 15 to 40 degrees, relative to a horizontal plane. It has been found that such an inclined dividing seam can combine a comparatively easy detachability of the designated sections of the dividing seam with high mechanical stability of the remaining seams, in particular the circumferential seam.

[0017] In one variant, the at least one dividing seam is substantially straight or substantially curved. A chord of the curved dividing seam runs obliquely. In the case of a curved seam, the radius of the curve can be 50 mm to 600 mm. Preferably, the radius of the curve is 60 mm to 120 mm. More preferably, the radius of the curve is 70 mm to 90 mm. It has been shown that such seams can combine comparatively easy detachability with comparatively high stability compared to other seams.

[0018] In one embodiment, the at least one dividing seam at least temporarily separates an uppermost and a lowermost product chamber from each other. In such a configuration, it is particularly important that the dividing seam is easily releasable and the adjacent circumferential seam is particularly stable. This is achieved by the reinforcing element, so that in such a configuration, unwanted leaks are particularly prevented.

[0019] The reinforcing element can be shaped like a circular segment or a polygonal segment. For example, the reinforcing element has the shape of a rectangle. Alternatively, the reinforcing element can be trapezoidal. According to a further alternative, the reinforcing element is triangular, quadrangular, pentagonal, or hexagonal. It is also possible for the reinforcing element to be shaped as a segment of a triangle, quadrilateral, pentagon, or hexagon. According to a further alternative, the reinforcing element is semicircular. Such reinforcing elements can be relatively easily implemented during container manufacture. Furthermore, they achieve the desired reinforcing effect. At the same time, they are relatively compact, so that they have little or no impact on the product volume of the container.

[0020] The reinforcing element can be three-dimensionally shaped. In this context, the reinforcing element extends, in particular, from an area defined by the first flexible film and the second flexible film. For example, the reinforcing element is cup-shaped. Such a configuration results in a particularly advantageous combination of an easily detachable dividing seam and a mechanically stable circumferential seam.

[0021] In one example, a largest dimension of the reinforcement element is at least 20 mm, preferably at least 25 mm. This can be a height or a width of the reinforcement element. It has been found that such a dimension of the reinforcement element represents a good compromise between ease of manufacture, high reinforcement effect, and compactness.

[0022] Preferably, the reinforcing element has an area of ​​at least 200 mm 2, preferably of at least 250 mm 2 , In this context, the reinforcing element may have a maximum area of ​​600 mm 2 , preferably not more than 500 mm 2 Such a reinforcement element combines a comparatively small space requirement with a high reinforcement effect.

[0023] The container may comprise an additional reinforcement element arranged outside the connection zone and protruding locally from the circumferential seam. The additional reinforcement element has the same effects and advantages already mentioned with regard to the first reinforcement element. The examples and variants mentioned in connection with the first reinforcement element can also be combined with the additional reinforcement element.

[0024] The product space of the container can have a capacity of at least 500 ml, preferably at least 1000 ml. The product space is therefore comparatively large. In order to securely hold a medical device and / or nutritional product provided in the product space within the container and / or to securely separate components of the medical device and / or nutritional product from one another, such containers must be particularly mechanically stable. At the same time, at least one section of the at least one dividing seam must be manually detachable. This is achieved in a particularly advantageous manner by means of the reinforcing element according to the invention.

[0025] The invention is explained below with reference to various embodiments shown in the accompanying drawings. Fig. 1 shows a container according to the invention according to a first embodiment, Fig. 2 a container according to the invention according to a second embodiment, Fig. 3 a container according to the invention according to a third embodiment, and Fig. 4 a container according to the invention according to a fourth embodiment.

[0026] Fig. Figure 1 shows a container 10 according to a first embodiment. This container is designed to hold a mixable nutritional product.

[0027] The container 10 comprises a first flexible film 12 and a second flexible film 14, which are arranged one on top of the other.

[0028] Both the first flexible film 12 and the second flexible film 14 are made of a multilayer polymer material. The container 10 can therefore also be referred to as a bag.

[0029] A product space 16 of the container 10 is thus delimited by opposite sides of the first flexible film 12 and the second flexible film 14 as well as by a circumferential seam 18 which permanently locally connects the first flexible film 12 and the second flexible film 14.

[0030] In the illustrated embodiment, the product chamber 16 has a capacity of approximately 2500 ml. This means that a maximum of 2500 ml of a mixable nutritional product can be accommodated in the product chamber 16.

[0031] The container 10 is designed as a multi-chamber container.

[0032] In the illustrated embodiment, the container 10 comprises a total of three product chambers 20a, 20b, 20c.

[0033] The product chamber 20a is an uppermost product chamber. It is bounded by a portion of the circumferential seam 18, as well as by a first dividing seam 22 and a second dividing seam 24.

[0034] The product chamber 20b is a central product chamber. It is bounded by a portion of the circumferential seam 18, by the first dividing seam 22, and by a third dividing seam 26.

[0035] The product chamber 20c is a lower product chamber. It is bounded by a portion of the circumferential seam 18, by the second dividing seam 24, and by the third dividing seam 26.

[0036] The container 10 also comprises an outlet interface 28. This is integrated into the circumferential seam 18 and borders on the product chamber 20c, ie the lower product chamber.

[0037] The product space 16 is thus subdivided into three product chambers 20a, 20b, 20c by means of the three dividing seams 22, 24, 26.

[0038] In the present case, the designations of the product chambers 20a, 20b, 20c refer to a use position of the container 10. In a use position, the container 10 is usually suspended from a stand so that the outlet interface 28 points vertically downwards.

[0039] Each of the product chambers 20a, 20b, 20c can contain a component of the mixable nutritional product. For example, one of the components is rich in glucose. Another of the components is rich in lipids, and another component is rich in amino acids.

[0040] In a stored state of the container 10, each of the first dividing seam 22, the second dividing seam 24, and the third dividing seam 26 locally connects the first flexible film 12 and the second flexible film 14 over their entire lengths. Thus, in the stored state, the components of the mixable nutritional product are separated from one another.

[0041] If the nutritional product is to be administered to a patient or customer, the components must be mixed.

[0042] For this purpose, the second dividing seam 24 and the third dividing seam 26 are designed as detachable seams. This means that the connection between the first flexible film 12 and the second flexible film 14 formed by these dividing seams 24, 26 can be released or broken by mechanical action on the container 10.

[0043] In this way, the components present in the product chambers 20a, 20b, 20c can mix.

[0044] In the present example, the first dividing seam 22 is designed as a permanent seam. This means that this seam is not intended to break the connection between the first flexible film 12 and the second flexible film 14.

[0045] In the first embodiment, the first dividing seam 22 and the third dividing seam 26 are also curved. The second dividing seam is straight per se, but is inclined at an angle W relative to a horizontal line. The angle W is approximately 20°.

[0046] The dividing seams 22, 24, 26 also meet at a so-called crossing point 30.

[0047] Each of the dividing seams 22, 24, 26 extends from the intersection point 30 to the circumferential seam 18.

[0048] The first dividing seam 22 separates the product chamber 20a and the product chamber 20b, i.e. the uppermost product chamber and the middle product chamber.

[0049] The second dividing seam 24 separates the product chamber 20a and the product chamber 20c, i.e. the uppermost product chamber and the lowermost product chamber.

[0050] The third dividing seam 26 separates the product chamber 20b and the product chamber 20c, i.e. the middle and the lowest product chamber.

[0051] The areas in which each of the dividing seams 24 meets the circumferential seam 18 represent connection zones 32.

[0052] In the first embodiment, a reinforcing element 34 is also provided, which lies outside the connection zones 32. The reinforcing element 34 lies essentially halfway up the Fig. 1 right-hand edge of the product chamber 20c and / or the connecting zone 32, in which the third dividing seam 26 meets the circumferential seam 18.

[0053] The reinforcing element 34 is designed as a flat seam segment that permanently locally connects the first flexible film and the second flexible film 14.

[0054] The reinforcing element 34 is also circular in shape. The circular segment has a radius R1 of 16 mm.

[0055] In addition, the reinforcing element 34 merges into the circumferential seam 18 via radii R2. The radii R2 are 6 mm.

[0056] In addition, the reinforcing element 34 has a height H which, in the example shown, is 30 mm.

[0057] In the example shown, the width B of the reinforcement element 34 is 10 mm. The width B is measured starting from an edge of the circumferential seam 18. The reinforcement element 34 thus protrudes by 10 mm from the circumferential seam 18. This occurs toward the interior of the product space 16.

[0058] In the first embodiment, the height H of the reinforcing element 34 is therefore its largest dimension.

[0059] In the embodiment shown, the surface area of ​​the reinforcing element 34 is approximately 250 mm2 .

[0060] It is understood that the container 10 according to the first embodiment may optionally also comprise further reinforcing elements which are shaped and dimensioned like the reinforcing element, but are arranged at other locations outside the connecting zones 32.

[0061] A second embodiment of the container 10 is shown in Fig. 2. Only the differences compared to the first embodiment will be discussed below.

[0062] In contrast to the first embodiment, the second dividing seam 24 no longer runs obliquely, but essentially horizontally.

[0063] The shape and dimensions of the reinforcing element 34 are the same as in the first embodiment. Optionally, additional reinforcing elements may also be present, as explained in connection with the first embodiment.

[0064] A third embodiment of the container 10 is shown in Fig. 3. In the following, only the differences compared to the previously explained embodiments will be discussed.

[0065] In contrast to the first and second embodiments, the reinforcing element 34 in the third embodiment is formed by a seam segment 40 projecting convexly towards an interior of the product space 16.

[0066] The seam segment 40 is designed as a kind of indentation of the circumferential seam 18.

[0067] The seam segment 40 is circularly arc-shaped, with the arc segment representing the seam segment 40 having a radius R1. In the example shown, the radius R1 is 26 mm.

[0068] Furthermore, the seam segment 40 merges into the adjacent sections of the circumferential seam 18 via radii R2. In the third embodiment, the radii R2 are 8 mm.

[0069] Since the seam segment 40 protrudes convexly towards the interior of the product space 16, different sections of the seam segment 40 protrude to different degrees from the adjacent sections of the circumferential seam 18.

[0070] In this context, a width B of the reinforcing element 34 is measured at the point where the reinforcing element 34 protrudes maximally from the circumferential seam 18. In the example shown, the width B is 10 mm. The width B is measured starting from an edge of the circumferential seam 18. The reinforcing element 34 therefore protrudes by 10 mm from the circumferential seam 18.

[0071] In addition, the reinforcing element 34 has a height H which, in the example shown, is 30 mm.

[0072] In the example shown, a seam width of the circumferential seam 18 and a seam width of the seam segment 40 are the same. However, it is understood that these seam widths can also be different. For example, a seam width of the seam segment 40 is larger than a seam width of the circumferential seam 18. Alternatively, a seam width of the seam segment 40 can be smaller than a seam width of the circumferential seam 18.

[0073] A further difference compared to the previously explained embodiments is that in the third embodiment, the reinforcing element 34 is provided in the product chamber 20a. The reinforcing element 34 is arranged in such a way on the Fig. 3 right-hand edge of the product chamber 20a, such that a vertex of the circular arc-shaped seam section 40 is at a distance of 25 mm from the second dividing seam 24.

[0074] A fourth embodiment of the container 10 is shown in Fig. 4. Only the differences compared to the previously explained embodiments will be discussed below. The fourth embodiment can be viewed as a further development of the third embodiment of the container 10.

[0075] In this context, the fourth embodiment differs from the third embodiment in that in addition to the reinforcing element 34, a further reinforcing element 36 is provided.

[0076] The further reinforcing element 36 is also formed as a seam segment 40 that protrudes convexly toward the interior of the product space 16. The shape and dimensions of the further reinforcing element 36 correspond to the shape and dimensions of the reinforcing element 34. In other words, the reinforcing element 34 and the further reinforcing element 36 are of the same design.

[0077] The further reinforcement element 36 is positioned at the edge of the product chamber 20c. This edge is in the Fig. 4 shown on the right.

[0078] In addition, the reinforcing element 34 and the further reinforcing element 36 are arranged relative to each other such that the vertices of the circular arc-shaped seam sections 40, which form the reinforcing element 34 and the further reinforcing element 36, have a distance of 62 mm.

[0079] Ends of the reinforcing element 34 and the further reinforcing element 36 facing each other have a distance of 13 mm.

[0080] In this context, one of the reinforcing element 34 and another reinforcing element 36 is positioned on each side of the second dividing seam 24.

[0081] It is understood that the containers 10 according to the third and fourth embodiments can also optionally have further reinforcing elements arranged at other locations outside the connecting zones 32. Containers 10 are also conceivable which have reinforcing elements 34 as in the Fig. 1 and Fig. 2 and reinforcement elements as shown in the Fig. 3 and Fig. 4 shown in combination.

[0082] Although the reinforcing elements 34, 36 were presented as two-dimensional, flat elements in the above embodiments, it is conceivable to alternatively shape each of the reinforcing elements 34, 36 of the aforementioned embodiments three-dimensionally. Reinforcing elements 34, 36 shaped in this way would then have an extension component that protrudes into or out of the plane of the drawing. For example, the reinforcing elements 34, 36 could be cup-shaped.

[0083] Furthermore, it is understood that, despite the fact that the container 10 explained with reference to the above examples is designed to hold a mixable nutritional product, such containers 10 can also be designed to hold a mixable medical product. List of reference symbols 10 containers 12 first flexible film 14 second flexible film 16 Product room 18 circumferential seam 20a Product chamber 20b Product chamber 20c Product chamber 22 first subdivision seam 24 second dividing seam 26 third subdivision seam 28 Outlet interface 30 crossing point 32 Connection zone 34 Reinforcing element 36 additional reinforcement element 40 suture segment R1 radius R2 radius H Height B Width W angle

Claims

[1] Container (10) for a mixable medical product and / or a mixable nutritional product, wherein the container (10) comprises a first flexible film (12) and a second flexible film (14) arranged on top of one another, wherein a product space (16) is delimited by respective opposite sides of the first flexible film (12) and the second flexible film (14) and by a circumferential seam (18) which permanently locally connects the first flexible film (12) and the second flexible film (14), wherein the product space (16) is subdivided into at least two product chambers (20a, 20b, 20c) by means of at least one dividing seam (22, 24, 26), wherein the at least one dividing seam (22, 24, 26) temporarily connects the first flexible film (12) and the second flexible film (14) locally and at least in sections, wherein the at least one dividing seam (22, 24, 26) meets the circumferential seam (18) in a connecting zone (32), wherein at least one reinforcing element (34) is provided outside the connecting zone (32), which locally connects the first flexible film (12) and the second flexible film (14). [2] Container (10) according to claim 1, wherein the reinforcing element (34) is a flat seam segment. [3] Container (10) according to claim 1 or 2, wherein the reinforcing element (34) is a seam segment (40) projecting convexly towards an interior of the product space (16). [4] Container according to one of the preceding claims, wherein the reinforcing element (34) protrudes by at least 10 mm from the circumferential seam (18). [5] Container (10) according to one of the preceding claims, wherein the at least one dividing seam (22, 24, 26) runs obliquely in a use position of the container (10). [6] Container (10) according to claim 5, wherein the at least one dividing seam (22, 24, 26) is inclined by 0 to 60 degrees, preferably by 15 to 40 degrees, relative to a horizontal. [7] Container (10) according to claim 5 or 6, wherein the at least one dividing seam (22, 24, 26) is substantially straight or arcuate, wherein a chord of the arcuate dividing seam (22, 24, 26) is oblique. [8] Container (10) according to one of the preceding claims, wherein the dividing seam (22, 24, 26) at least temporarily separates an uppermost and a lowermost product chamber (20a, 20c) from one another. [9] Container (10) according to one of the preceding claims, wherein the reinforcing element (34) is in the shape of a circular segment or a polygonal segment. [10] Container (10) according to one of the preceding claims, wherein the reinforcing element (34) is three-dimensionally shaped. [11] Container (10) according to one of the preceding claims, wherein a largest dimension of the reinforcing element (34) is at least 20 mm, preferably at least 25 mm. [12] Container (10) according to one of the preceding claims, wherein the reinforcing element (34) has an area of at least 200 mm 2 , preferably of at least 250 mm 2 , has. [13] Container (10) according to one of the preceding claims, comprising a further reinforcing element (36) arranged outside the connection zone and protruding locally from the peripheral seam (18). [14] Container (10) according to one of the preceding claims, wherein the product space (16) has a capacity of at least 500 ml, preferably of at least 1000 ml.

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