Flexible plastic container intended for holding a fluid

Abstract

The invention relates to a container (1) for containing a fluid comprising an outer casing (2) having two flexible sheets joined together (3,4) along a peripheral joint (5) so as to define an internal compartment (6) containing or intended to contain a fluid, said container (1) further having an upper part (7) and a lower part (8) between which the internal compartment (6) is placed, said lower part having a suspension opening (11) for suspending said container (1), characterized in that said lower part (8) further comprises a barrier rib (15) surrounding at a distance said suspension opening (11), said barrier rib (15) rising from the surface of one of said flexible sheets (3,4), to a height of two to three times the thickness of the peripheral joint in the lower part of the container,

Description

[0001] The present invention relates to a flexible plastic container and a method for manufacturing such a container.

[0002] It applies in particular to the field of flexible plastic containers intended to hold a biological fluid and / or for medical or pharmaceutical use. Such fluids include, for example, blood or a blood component, a cell culture medium, a nutrient solution, an intravenous injectable solution, or a drug solution.

[0003] In the field of transfusion, and according to ISO 3826 (2019), flexible plastic bags for blood and blood components must be equipped with one or more outlet ports for administering blood and blood components, as well as a means of suspending or hanging the bag. Transfusion is then performed by connecting a transfusion set to the bag's outlet port and suspending the bag using the suspension device. This suspension device must be able to withstand a certain tensile force to prevent the bag from falling when suspended.

[0004] This means of suspension is generally made in the form of an opening or slit made on the edge of the bag, on the side opposite to the side including the outlet fitting.

[0005] As an example, US patent 4,352,669 discloses a blood component bag with two outlet fittings on one side and an oval-shaped hanging opening on the opposite side. This hanging opening is created by weld-cut during the bag's manufacture and its perimeter includes a weld bead.

[0006] Similarly, document BE 875 532 A describes a flexible single-dose liquid container having a flow section comprising one or more passages for liquid inlet and outlet, and opposite it, a tab section comprising a hanging opening for suspending the container. The perimeter of the hanging opening includes a reinforcing rib to prevent the tab section from tearing when the bag is suspended. Furthermore, a transverse rib is provided at the end of the tab section for aesthetic reasons and to improve the ease of suspension.

[0007] To reduce the risk of tearing of these suspension means, US patent 2010 / 0294693 proposes a blood component bag with suspension means in the form of slots positioned in the middle of the bag's peripheral weld. Furthermore, the slots have curved sections at each end to reduce stress from the bag's weight at that point, thus further minimizing the risk of tearing that could lead to the bag falling. As in the previous patent, the slots are bordered by a weld bead. A weld line left by the weld-cutting tool is shown at a distance from this bead. This weld line is not large enough to prevent tearing of the suspension slots.

[0008] The invention proposes a container for holding a fluid provided with a means of suspension or attachment having improved resistance to breakage, thus reducing the risk of the container falling when suspended from a hook.

[0009] Accordingly to a first aspect, the invention relates to a container containing or intended to contain a fluid comprising an outer shell having two flexible sheets joined together along a peripheral joint so as to define an internal compartment containing or intended to contain the fluid, said container further having an upper part and a lower part between which the internal compartment is placed, said peripheral joint extending at least over said lower part of the container, said lower part having a suspension opening intended to suspend said container and a barrier rib surrounding said suspension opening at a distance, said barrier rib rising to a height of 0.7 to 1.4 mm from the surface of one of said flexible sheets.

[0010] According to a second aspect, the invention relates to a method for manufacturing a container according to the first aspect of the invention, said method comprising at least the following steps: a) provide at least a first and second die, at least the first die being provided with a raised imprint whose geometry corresponds to the geometry of the peripheral seal of said container, said imprint further comprising a groove whose geometry corresponds to the geometry of the dam rib; b) arrange between said first and second dies a stack of two flexible sheets; c) join said flexible sheets together by bringing the first and second dies together in order to form said peripheral seal of the container; and d) make the suspension opening in the lower part of said container.

[0011] The attached drawings illustrate the invention: [ Fig. 1 [ ] schematically represents a container provided with a suspension opening according to the invention. ] Fig. 2 ] schematically represents a partial and enlarged view of the container of the figure 1 . [ Fig. 3 ] schematically represents a perspective view of the first welding matrix used to make the container of the figure 1 . [ Fig. 4 ] schematically represents a partial, enlarged top view of the first welding matrix of the figure 3 . [ Fig. 5 ] schematically represents a perspective view of the second welding matrix used to make the container of the figure 1 .

[0012] There figure 1 represents a container 1 containing or intended to contain a fluid according to the invention. This container is, for example, intended to contain a fluid such as blood or blood components for transfusion to a patient. In another example, the container is intended to contain a fluid for medical or pharmaceutical use, such as an infusion solution. Alternatively, the container includes a medium for cell culture.

[0013] This container includes an outer casing 2 having two flexible sheets 3,4 joined together along a peripheral joint 5 so as to define an internal compartment 6 containing or intended to contain the fluid.

[0014] The flexible sheets are made of a flexible and sterilizable thermoplastic material such as polyvinyl chloride. Specifically, each flexible sheet has a thickness ranging from 0.20 to 0.50 mm, particularly around 0.35 mm. The thickness of the peripheral joint resulting from welding these two flexible sheets ranges from 0.30 to 0.60 mm, particularly around 0.40 mm.

[0015] The container 1 comprises an upper part 7 and a lower part 8 between which the internal compartment 6 is placed.

[0016] The terms "upper" and "lower" are defined in relation to the direction in which the container is used when filling it.

[0017] According to the implementation of the figure 1 The lower part 8, in contact with the internal compartment 6, has a concave shape. The upper part 7, in contact with the internal compartment 6, has a convex shape.

[0018] According to the figure 1 , the peripheral seal 5 extends over said upper part 7 of the container.

[0019] The upper part 7 of the container, located above the internal compartment 6, includes at least one tube 9a for access to the internal compartment 6 of said container 1.

[0020] According to the implementation of the figure 1 The upper part 7 of the container 1 comprises four access tubes 9a, 9b, 9c, 9d. Two tubes 9a and 9b are fitted with a pierceable cap that hermetically seals said tubes. These tubes 9a and 9b are also fitted with a breakable cap 10a and 10b having fins.

[0021] The other two tubes 9c,9d of container 1 are intended to be assembled with tubing (not shown).

[0022] Depending on the configuration of the figure 1 , the peripheral seal 5 extends over the lower part 8 of the container 1.

[0023] Furthermore, the lower portion 8 of the container 1 has at least one suspension opening 11 for suspending said container 1 from a hook. The suspension opening 11 consists of a slot. More specifically, the suspension opening 11 is a slot shaped like a clip, the crown of which is parallel to the lower edge of the container 1 and the prongs of which are folded towards the inner compartment 6 of the container 1. The ends of the clip's crown are rounded.

[0024] In an alternative not shown, the clips' tabs are folded on the opposite side of the internal compartment 6, towards the lower periphery of the container 1.

[0025] The portion inside the clip forms a tab that pivots along the section between the two prongs of the clip. Lowering this tab creates an opening large enough to insert a hanging hook. This opening is essentially rectangular in shape with rounded corners.

[0026] On the figure 1 , the peripheral seal 5 defining the internal compartment 6 of the container extends to the perimeter of said container 1.

[0027] Depending on the configuration of the figure 1 The peripheral seal 5 in the upper part 7 of the container comprises one or more closed upper cavities 12a, 12b, 12c, 12d, 12e at which the flexible sheets are separated from each other. In other words, at these cavities, the flexible sheets 3, 4 are not welded. These closed cavities are located on either side of the access tubes 9a, 9b, 9c, 9d.

[0028] Similarly, the peripheral seal 5 extending into the lower part 8 of the container 1 comprises one or more closed cavities 13a, 13b at which the two flexible sheets 3, 4 are separated from each other. In other words, at these cavities, the flexible sheets 3, 4 are not welded.

[0029] On the figures 1 et 2 The lower part 8 of the container 1 comprises two lower cavities 13a, 13b. In this embodiment, the suspension opening 11 is arranged in the peripheral joint 5, i.e. at a location where the two flexible sheets 3,4 are welded together.

[0030] On the figures 1 et 2 The suspension opening 11 of the container is further bordered by a reinforcing rib 14. This reinforcing rib 14 is formed, in particular, during the creation of the suspension opening 11 using a welding-cutting tool as described in more detail below. For example, this reinforcing rib 14 has a width of approximately 1 mm and a height of approximately 1 mm.

[0031] This reinforcing rib 14 is distinct from the dam rib 15 described below and forms a means of reinforcing the suspension opening 11 by accumulating material around the perimeter of the suspension opening 11.

[0032] According to the invention, said lower part 8 of the container 1 includes a barrier rib 15 surrounding at a distance said suspension opening 11. This barrier rib 15 is away from the suspension opening 11.

[0033] In the configuration of the figure 1 , the barrier rib 15 is continuous and completely surrounds the suspension opening 11. Thus, wherever the tear in the suspension opening starts, if any, the tear will not be able to propagate to the periphery of the container 1 by bypassing this barrier rib.

[0034] In the form of implementation of the figure 1 The barrier rib 15 is arranged in the peripheral seal 5 of the lower part 8 of the container, that is to say, at a location where the flexible sheets 3, 4 are welded together. This barrier rib 15 constitutes a barrier in the event of a tear in the suspension opening.

[0035] Indeed, when suspending container 1 from a hook, the passage of the hook sometimes causes a tear to begin at the suspension opening which, with the weight of the container, risks spreading to the perimeter of the container.

[0036] The presence of the damming rib 15 forms a barrier that prevents or hinders the propagation of the tear.

[0037] This dam rib 15 has a closed shape such as a square, rectangle, circle, oval, ellipse, or other polygon. Advantageously, the dam rib 15 substantially has the shape of the suspension opening 11. On the figure 1 , the dam rib 15 takes the form of a rectangle with rounded corners.

[0038] The dam rib 15 extends over a height of 0.7 to 1.4 mm from the surface of one of the two flexible leaves 3,4 forming the container 1. More particularly, the dam rib 15 extends over a height of about 1 mm from the surface of one of the flexible leaves 3,4.

[0039] Advantageously, the barrier rib 15 extends on both sides of the container 1. In this case, the barrier rib extends from the surface of either of the flexible sheets 3, 4 to a height of 0.7 to 1.4 mm. In particular, the barrier rib 15 extends symmetrically on both sides of the container 1. Even more particularly, the barrier rib extends to a height of approximately 1 mm on both sides of said container.

[0040] This height corresponds to approximately two to three times the thickness of the peripheral seal 5 located in the lower part of the container.

[0041] A barrier rib height less than twice the thickness of the peripheral joint is insufficient to prevent tear propagation. A barrier rib height greater than three times the thickness of the peripheral joint leads to production difficulties.

[0042] According to one design, the dam rib has a width approximately equal to its height, i.e. about 1 mm.

[0043] The geometry of this dam rib is designed to resist tearing. With this geometry, a single dam rib around the suspension opening is sufficient to prevent or slow the propagation of any potential tear.

[0044] As an example, the opening of suspension 11 of the figure 1 It has a length of approximately 29 mm. The dam rib 15 is located at a distance of between 1 and 5 mm, more specifically between 2 and 4 mm, from the suspension opening. The dam rib 15 has a width substantially equal to or greater than the width of the reinforcing rib 14.

[0045] As explained in more detail below, the barrier rib 15 is formed during the fabrication of the flexible container by welding. In this case, the barrier rib 15 consists of a weld bead.

[0046] The weld bead surrounds the suspension opening, distributing excess material over a relatively long length and ensuring its homogeneity. Furthermore, if the weld bead were not closed, protrusions could appear at the ends, creating weak points prone to tearing.

[0047] A method for manufacturing a container intended to hold a fluid according to the first aspect of the invention is described below.

[0048] The process includes the steps of a) provide at least a first and second dies, at least the first die 16 being provided with a raised imprint 17 whose geometry corresponds to the geometry of the peripheral seal 5 of said container, said imprint further comprising a groove 18 corresponding to the geometry of the dam rib 15; b) arrange between said dies a stack of two flexible sheets of the container; and c) join said sheets together by bringing the first and second dies together in order to form said peripheral seal of the container; and d) make the suspension opening in the lower part of said container.

[0049] According to one design, the flexible sheets are joined by welding, in particular by high-frequency welding or thermal welding.

[0050] In particular, high-frequency welding is carried out using a pair of metallic electrodes forming the matrices. These electrodes are placed on either side of the flexible sheets to be joined.

[0051] THE figures 3 et 5 represent, respectively, a first matrix 16 and a second matrix 20 used for the welding assembly of the flexible sheets and tubes constituting the container 1 of the figure 1 These matrices allow the formation of, in particular, the peripheral seal 5, the suspension opening 11 and the barrier rib 15 of the container of the figure 1 .

[0052] The first die 16 and the second die 20 each include an upper portion 21,22 to form the upper part of the container 1 comprising the access tubes 9a-9d. These access tubes 9a-9d of the container 1 are placed between the two flexible sheets prior to the formation of the peripheral seal.

[0053] In addition, the first matrix 16 and the second matrix 20 each include a lower portion 23,24 to form the rest of the container.

[0054] In one embodiment, the process further includes the step of inserting at least one access tube 9a between the flexible sheets 3,4 prior to the formation of the peripheral joint 5.

[0055] For example, in one embodiment, a first weld is performed to form the portion of the peripheral seal of the upper part of the vessel containing the access tubes, and then a second weld is performed to form the remainder of the peripheral seal, the suspension opening, and the barrier rib. Alternatively, these two welding steps are performed in reverse order or simultaneously.

[0056] On the figures 3 et 4 , a lower portion 23 of the first die 16 includes a raised imprint 17 whose geometry corresponds to the geometry of a portion of the peripheral seal 5 of the container 1. The imprint 17 also includes a groove 18 corresponding to the barrier rib, said groove being arranged on said raised imprint 17. This lower portion of the first die 16 further includes a welding-cutting member 19 to form the suspension opening 11 and the reinforcing rib 14 of the container 1.

[0057] The geometry of the groove 18 corresponds to the geometry of the dam rib 15, that is to say that the dimensions and shape of the groove are the negative of the dam rib 15.

[0058] The second matrix 20 illustrated on the figure 5 has an upper portion 22 identical to the upper portion 21 of the first matrix 16, and a lower portion 24 having a flat surface. In this case, the weld bead forming the dam rib is formed only on one side of the container 1.

[0059] In an alternative not shown, the second die is identical to the first die and also includes a raised imprint corresponding to the geometry of the peripheral seal of the container, with a groove corresponding to the dam rib. In this case, the dam rib extends on each side of the container.

[0060] For welding, the matrices formed by the electrodes are used to compress the flexible sheets. The matrices are then energized by a high-frequency electric current. The high-frequency energy applied to the matrices causes the flexible sheets to heat and soften in the compression zone.

[0061] Due to the heating combined with compression, an excess of material appears which forms a weld bead on either side of the raised impression on the matrix.

[0062] Thus, during the production of the peripheral joint 5 forming the internal compartment 6, a weld bead is created on either side of the peripheral joint 5.

[0063] Similarly, excess material accumulates in the groove 18 of the first die to form the dam rib 15 in the form of a weld bead.

[0064] The presence of this groove 18 on the die also has the advantage of reducing the weld bead which is created inside the internal compartment 6 of the container 1.

[0065] In a particular configuration, groove 18 of the first die has a depth ranging from 0.7 to 1.4 mm, more specifically about 1 mm.

[0066] The suspension opening 11 is notably achieved using a welding-cutting device comprising a blade. On the figure 3 , the first die 16 is provided with such a welding-cutting element 19. Alternatively, the cutting is carried out by a welding-cutting element separate from the first die.

[0067] The welding-cutting element 19 includes, for example, a pointed or blade-shaped part defining the suspension opening and a hollowed-out part to allow excess material from the weld to accumulate and form the reinforcing rib 14.

Claims

1. [Container (1) containing or intended to contain a fluid comprising an outer casing (2) having two flexible sheets (3,4) joined together along a peripheral seal (5) so as to define an internal compartment (6) containing or intended to contain the fluid, said container (1) further having an upper part (7) and a lower part (8) between which the internal compartment (6) is placed, said peripheral seal (5) extending at least over said lower part (8) of the container, said lower part having at least one suspension opening (11) intended to suspend said container (1), characterized in thatsaid lower part (8) further includes a barrier rib (15) surrounding at a distance said suspension opening (11), said barrier rib (15) rising from the surface of one of said flexible sheets (3,4) to a height of two to three times the thickness of the peripheral seal in the lower part of the container.

2. Container according to claim 1, characterized in that the dam rib (15) extends over a height ranging from 0.7 to 1.4 mm from the surface of one of said flexible sheets (3,4).

3. Container according to claim 1 or 2, characterized in that the dam rib (15) extends symmetrically on either side of the container 1.

4. Container according to any one of claims 1 to 3, characterized in that the suspension opening (11) of said container is further bordered by a reinforcing rib (14).

5. Container according to any one of claims 1 to 4, characterized in thatthe peripheral joint (5) which extends into the lower part (8) includes one or more closed cavities (13a, 13b) at which the two flexible sheets (3,4) are separated from each other.

6. Container according to any one of claims 1 to 5, characterized in that the upper part (7) of said container includes at least one access tube (9a) to the internal compartment (6) of said container.

7. Container according to any one of claims 1 to 6, characterized in that the dam rib (15) is formed by a weld bead.

8. A method for manufacturing a container according to any one of claims 1 to 7, characterized in thatIt comprises at least the following steps: a) providing at least a first and second die, at least the first die (16) being provided with a raised imprint (17) whose geometry corresponds to the geometry of the peripheral seal (5) of said container, said raised imprint (17) further comprising a groove (18) whose geometry corresponds to the geometry of the dam rib (15); b) arranging between said first and second dies a stack of two flexible sheets (3,4); c) joining said flexible sheets together by bringing the first and second dies together in order to form said peripheral seal (5) of the container (1); and d) making the suspension opening (11) in the lower part (8) of said container.

9. Method according to claim 8, characterized in that the suspension opening (11) is made using a welding-cutting element (19) comprising a blade.

10. A method according to claim 8 or 9, characterized in that It further includes the step of inserting at least one access tube (9a) between the flexible sheets (3,4) prior to the formation of the peripheral joint (5).

11. A method according to any one of claims 8 to 10, characterized in that The flexible sheets are joined by high-frequency welding.