Bag intended to contain medical substance for intravenous injection
By designing the welding area of the medical bag, using the ratio of 1/3 to 3/4 and a specific angle, the crack of the peelable welding area is controlled, which solves the problem of incomplete mixing of pharmaceutical substances and retention, and achieves uniform mixing of drugs and full dose reception.
Patent Information
- Application Number
- CN202380042569.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-03-23
- Filing Date
- 2023-03-23
- Publication Date
- 2025-01-03
AI Technical Summary
In existing medical bags for intravenous injection, the crack control of the peelable weld part is poor, resulting in incomplete mixing of the medicinal substances, and the risk of film adhesion leads to drug retention, which cannot ensure that the patient receives the full dose.
A bag including a first wall and a second wall is designed, assembled by a welded zone, which comprises a permanent welded zone and a peelable welded zone, and the ratio of the third peelable welded zone is in the range of 1/3 to 3/4. , to control the location and degree of rupture, and to ensure uniform mixing of medicinal substances through specific angles and thickness designs.
Better control over the mixing of pharmaceutical substances is achieved, complete and even mixing of drugs is ensured, and the risk of drug retention is reduced, ensuring that patients receive the complete dose.
Smart Images

Figure CN119255779A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to a bag intended to contain a medicinal substance for intravenous injection, a method for preparing a medicinal solution with the aid of such a bag and a method for producing such a bag. Background Art
[0002] Bags intended to contain medicinal solutions (e.g., drugs, solutes, physiological solutions, or blood-derived products) for intravenous injection are flexible bags that can be connected to tubing to allow parenteral administration of the medicinal solution to a patient, or to allow the medicinal solution to be withdrawn from the bag with the aid of a syringe for administration to a patient.
[0003] These bags are typically made by welding together two flexible films of polymer material.
[0004] The bags can be sterilized by radiation before aseptic filling and / or by autoclaving after filling.
[0005] Document FR 3 058 638 A1 describes a medical bag formed of two transparent films and comprising a first compartment intended to be filled with a first compound in liquid form and a second compartment intended to be filled with a second compound in powder form. The medical bag comprises a permanent weld located at the periphery of the bag and a peelable weld located between the two compartments. The peelable weld is intended to break at the moment the bag is used, thereby placing the first compartment in communication with the second compartment in order to mix the first compound and the second compound together before administration to a patient.
[0006] Such bags allow packaging of very unstable medicinal substances that cannot be preserved when mixed and that need to be mixed together in order to reconstitute a pharmaceutical solution before administration to a patient.
[0007] One problem with these bags is that rupture of the peelable weld is not always well controlled.
[0008] However, depending on where and how far the peelable weld breaks, there is a risk that the first compound is not mixed in the entire volume of the second compartment. In this case, mixing between the two compounds is incomplete, which results in an inability to determine whether the prescribed dosage has been met.
[0009] In addition, during the administration of the medicinal substance, there is a risk that the two films will stick together, thus forming a stagnation zone, which prevents the bag from completely emptying itself. In this case, the patient does not receive the entire medicinal substance. Summary of the invention
[0010] One object is to propose a bag intended to contain medicinal substances for intravenous injection which allows obtaining a better control over the mixing between the two medicinal substances.
[0011] This object is achieved by a bag intended to contain a medicinal substance for intravenous administration, comprising:
[0012] - the first wall, and
[0013] - second wall,
[0014] the first wall and the second wall are assembled together by a weld zone, the weld zone delimiting at least one first compartment intended to contain a first medicinal substance and at least one second compartment intended to contain a second medicinal substance,
[0015] The welding area includes:
[0016] - a first permanent weld zone extending along a first longitudinal edge of the bag,
[0017] - a second permanent weld extending along a second longitudinal edge of the bag opposite the first longitudinal edge, and
[0018] - a third peelable weld separating the first compartment from the second compartment,
[0019] wherein the third peelable weld zone extends from the first permanent weld zone to the second permanent weld zone so as to form a first joint between the third peelable weld zone and the first permanent weld zone, and a second joint between the third peelable weld zone and the second permanent weld zone,
[0020] And wherein a ratio l / L between a dimension l of the third peelable weld measured along the transverse axis between the first joint and the second joint and a dimension L measured along an axis parallel to the transverse axis and passing through the first compartment between the first permanent weld and the second permanent weld is included in a range extending from 1 / 3 to 3 / 4.
[0021] The specific size ratio between the third peelable weld and the spacing between the two permanent welds allows controlling in a reproducible manner where the rupture occurs and the extent of the rupture.
[0022] In fact, it has been observed that a ratio l / L of less than 1 / 3 has the effect that the third peelable weld is difficult to break. In this case, the degree of rupture of the third peelable weld may be insufficient, which does not allow a sufficient flow rate of the first medicinal substance penetrating into the second compartment to be generated, and a complete and uniform mixing with the second medicinal substance cannot be guaranteed.
[0023] A ratio l / L greater than 3 / 4 has the effect that the stress applied to the third peelable weld is not evenly distributed along the third peelable weld. In this case, it is impossible to accurately control the location where the third peelable weld breaks, which does not allow to favorably position the flow of the first medicinal substance penetrating into the second compartment, and it is impossible to ensure complete and uniform mixing with the second medicinal substance.
[0024] On the other hand, as proposed, when the ratio l / L is included in the range extending from 1 / 3 to 3 / 4, the flow orientation and intensity of the first medicinal substance penetrating into the second compartment can be controlled without having to exert excessive pressure on the first compartment. This allows a complete and uniform mixing of the two substances to be obtained in a reproducible manner.
[0025] The bag may also have the following features:
[0026] - The ratio l / L is comprised in a range extending from 1 / 3 to 2 / 3.
[0027] -The first permanent weld zone includes a first longitudinal portion extending parallel to the first longitudinal edge of the bag and a first expansion portion extending from the first longitudinal portion to the first joint, the first expansion portion defining a first compartment by forming a first angle with a transverse axis extending perpendicular to the longitudinal edge, the first angle being included in the range extending from 0° to +70°, and the second permanent weld zone includes a second longitudinal portion extending parallel to the second longitudinal edge of the bag and a second expansion portion extending from the second longitudinal portion to the second joint, the second expansion portion defining the first compartment by forming a second angle with the transverse axis, the second angle being included in the range extending from -70° to 0°.
[0028] The first angle is comprised in a range extending from 0° to +50° relative to the transverse axis, and the second angle is comprised in a range extending from -50° to 0° relative to the transverse axis.
[0029] The first angle is comprised in a range extending from +20° to +50° relative to the transverse axis, and the second angle is comprised in a range extending from -50° to -20° relative to the transverse axis.
[0030] -The first permanent weld zone includes a third longitudinal portion extending parallel to the first longitudinal edge of the bag and a third expansion portion extending from the third longitudinal portion to the first joint, the third expansion portion defining a second compartment by forming a third angle with a transverse axis extending perpendicular to the longitudinal edge, the third angle being included in the range extending from -70° to 0°, and the second permanent weld zone includes a fourth longitudinal portion extending parallel to the second longitudinal edge of the bag and a fourth expansion portion extending from the fourth longitudinal portion to the second joint, the fourth expansion portion defining a second compartment by forming a fourth angle with the transverse axis, the fourth angle being included in the range extending from 0° to +70°.
[0031] The third angle is included in the range extending from -50° to 0° relative to the transverse axis, and the fourth angle is included in the range extending from 0° to +50° relative to the transverse axis.
[0032] The third angle is comprised in a range extending from -50° to -20° relative to the transverse axis, and the fourth angle is comprised in a range extending from +20° to +50° relative to the transverse axis.
[0033] - the first permanent weld zone and the second permanent weld zone have been obtained by fusing the first wall and the second wall at a first temperature, and the third peelable weld zone has been obtained by fusing the first wall and the second wall at a second temperature lower than the first temperature, so that when a first medicinal substance is received in the first compartment and pressure is applied on the first compartment, the pressure applied on the first compartment causes the third peelable weld zone to rupture, thereby allowing the first medicinal substance to penetrate into the second compartment.
[0034] - The bag comprises a first medicinal substance contained in a first compartment.
[0035] - The first medical substance is a liquid substance.
[0036] - The bag comprises a second medicinal substance contained in the second compartment.
[0037] - The second medicinal substance is a powder or a lyophilisate.
[0038] The medicinal solution can be prepared by means of a method for preparing a medicinal solution using a bag as described above, wherein a first compartment of the bag contains a first medicinal substance and a second compartment of the bag contains a second medicinal substance, the method comprising the step of pressing the first compartment so as to rupture the third peelable weld area, thereby allowing the first medicinal substance to penetrate into the second compartment.
[0039] The bag as described above can be manufactured according to a manufacturing method, which comprises the following steps:
[0040] - welding the first wall and the second wall together at a weld zone, the weld zone defining at least one first compartment intended to receive a first medicinal substance and at least one second compartment intended to receive a second medicinal substance, and
[0041] The welding area includes:
[0042] - a first permanent weld zone extending along a first longitudinal edge of the bag,
[0043] - a second permanent weld extending along a second longitudinal edge of the bag opposite the first longitudinal edge, and
[0044] - a third peelable weld separating the first compartment from the second compartment,
[0045] wherein the third peelable weld zone extends from the first permanent weld zone to the second permanent weld zone so as to form a first joint between the third peelable weld zone and the first permanent weld zone, and a second joint between the third peelable weld zone and the second permanent weld zone,
[0046] And wherein a ratio l / L between a dimension l of the third peelable weld measured between the first joint and the second joint and a dimension L of the first compartment measured between the first permanent weld and the second permanent weld is comprised in a range extending from 1 / 3 to 3 / 4.
[0047] The step of welding the first wall and the second wall together may include:
[0048] - welding the first wall and the second wall at a first permanent weld zone and a second permanent weld zone by fusing the first wall and the second wall at a first temperature, and
[0049] - Welding the first wall and the second wall together at a third peelable weld region by fusing the first wall and the second wall at a second temperature lower than the first temperature. BRIEF DESCRIPTION OF THE DRAWINGS
[0050] Other features and advantages will still be revealed by the following description, which is merely illustrative and not restrictive and must be read with reference to the accompanying drawings, in which:
[0051] - Figure 1 A bag intended to contain a medicinal substance for intravenous administration is schematically shown in a front view,
[0052] - Figure 2 The following view shows Figure 1 Bags,
[0053] - Figure 3schematically shows a bag intended to contain a medicinal substance for intravenous injection according to a first possible embodiment before filling,
[0054] - Figure 4 schematically shows a bag intended to contain a medicinal substance for intravenous injection according to a second possible embodiment before filling,
[0055] - Figure 5 Schematic diagram of the steps of preparing a pharmaceutical solution using a bag,
[0056] - Figure 6 schematically shows a bag intended to contain a medicinal substance for intravenous injection according to a third possible embodiment before filling,
[0057] - Figure 7 A bag intended to contain a medicinal substance for intravenous injection according to a fourth possible embodiment is schematically shown before filling. DETAILED DESCRIPTION
[0058] exist Figure 1 and Figure 2 In the figure, the bag 1 shown comprises a first wall 2, a second wall 3, a filling tube 4 and a connector 5.
[0059] The first wall 2 and the second wall 3 are assembled together by heat welding at a plurality of welding areas 6. The welding areas 6 define a first compartment 11 and a second compartment 12 separated from the first compartment 11 between the first wall 2 and the second wall 3.
[0060] The first compartment 11 contains a first medicinal substance and the second compartment 12 contains a second medicinal substance.
[0061] exist Figure 1 In the example shown, the first medicinal substance is a liquid substance and the second medicinal substance is a substance in powder form or a lyophilized agent. The powdered substance or lyophilized agent contains, for example, an active ingredient (such as an antibiotic, an anticancer drug, an antifungal drug or a blood derivative), and the liquid substance is, for example, a diluent suitable for diluting the powdered substance or lyophilized agent. The liquid substance and the powdered substance (or lyophilized agent) are intended to be mixed together just before administering the medicinal solution to a patient in order to prepare a medicinal solution.
[0062] The first wall 2 may be formed from a first film of a polymer material, for example a polymer material comprising a polyolefin, such as polypropylene or polyethylene.
[0063] Likewise, the second wall 3 may be formed from a second film that is the same as the first film.The second wall may be formed from a second film of a polymer material, for example a polymer material comprising a polyolefin, such as polypropylene or polyethylene.
[0064] The filling tube 4 is arranged between the first wall 2 and the second wall 3 so as to allow the first compartment 11 to be filled with the first medicinal substance via the filling tube 4. More precisely, the filling tube 4 has a first end with a first opening leading to the first compartment 11 and a second end opposite the first end with a second opening leading to the outside of the first compartment 11. More precisely, the second opening leads to the outside of the bag 1. The filling tube 4 also includes an internal passage extending from the first opening to the second opening.
[0065] The connector 5 closes the second opening of the filling tube 4 in a sealed manner. The connector 5 comprises a detachable part 51 which can be broken. Once broken, the detachable part 51 can be detached from the rest of the connector 5 and a needle can be inserted into the connector 5, for example in order to connect the filling tube 4 of the bag 1 to an intravenous infusion set or a syringe.
[0066] In addition, if Figure 1 As shown, the bag 1 may further comprise a first protection sheet 7 attached to the first wall 2 and / or a second protection sheet 8 attached to the second wall 3 .
[0067] The first protective sheet 7 covers the outer surface of the first wall 2 so as to shield the second compartment 12 but not the first compartment 11. Likewise, the second protective sheet 8 covers the outer surface of the second wall 3 so as to shield the second compartment 12 but not the first compartment 11.
[0068] The first protective sheet 7 and the second protective sheet 8 each form a barrier that prevents moisture, light and / or oxygen from penetrating through the first wall 2 and the second wall 3 , respectively, into the interior of the second compartment 12 containing the second medicinal substance.
[0069] To this end, the first protection sheet 7 and the second protection sheet 8 may each include an aluminum layer or a composite material layer including aluminum.
[0070] The first protective sheet 7 and / or the second protective sheet 8 can be attached to the first wall 2 and / or the second wall 3, respectively, by peelable welds, allowing the first protective sheet 7 and / or the second protective sheet 8 to be removed before using the bag. Removal of the first protective sheet 7 and / or the second protective sheet 8 can allow visual inspection of the condition of the second medicinal substance contained in the second compartment 12 before continuing to mix the first medicinal substance with the second medicinal substance.
[0071] Alternatively, the first protective sheet 7 and / or the second protective sheet 8 can be attached to the first wall 2 and / or the second wall 3, respectively, by permanent welding. In this case, the first protective sheet 7 and / or the second protective sheet 8 are not removed before using the bag. The first protective sheet 7 and / or the second protective sheet 8 can be transparent to light in the visible light range so as to allow visual inspection of the condition of the second medicinal substance contained in the second compartment 12.
[0072] The bag 1 may also have a hole 9 provided through the first wall 2 and the second wall 3 in the weld zone, the hole 9 allowing the bag 1 to be hung by a hook during use.
[0073] When the bag 1 is suspended from the hook, the second compartment 12 is arranged above the first compartment 11 and the filling tube 4 extends vertically downwards.
[0074] Figure 3 A bag 1 according to a first embodiment is schematically shown.
[0075] For example, Figure 3 The bag 1 shown may be sized such that the first compartment 11 is suitable for containing approximately 250 ml of a first medicinal substance in liquid form, while the second compartment 12 is suitable for containing from a few milligrams to a few hundred grams, for example 100 grams, of a second medicinal substance in powder form.
[0076] Figure 3 The bag 1 shown comprises a first longitudinal edge 14 , a second longitudinal edge 15 opposite the first longitudinal edge 14 , a first transverse edge 16 and a second transverse edge 17 opposite the first transverse edge 16 .
[0077] The bag 1 further comprises a plurality of welded areas 6 defining the first compartment 11 and the second compartment 12 .
[0078] More precisely, the weld zone 6 comprises a first longitudinal weld zone 64 extending along the first longitudinal edge 14 and a second longitudinal weld zone 65 extending along the second longitudinal edge 15 .
[0079] In addition, the weld zone 6 also comprises a first transverse weld zone 66 extending along the first transverse edge 16 .
[0080] exist Figure 3 , the bag 1 is shown before filling. That is, the first compartment 11 does not yet contain the first medicinal substance and the second compartment does not yet contain the second medicinal substance. This is why the weld zone 6 does not yet include a second transverse weld zone extending along the second transverse edge 17. Thus, the second medicinal substance can be introduced into the second compartment 12 via the opening present between the first wall 2 and the second wall 3, which have not yet been welded together along the second transverse edge 17.
[0081] However, once the second compartment 12 has been filled with the second medical substance, a second transverse weld zone 67 extending along the second transverse edge 17 may be formed (the second transverse weld zone 67 is at Figure 3 denoted by a dotted line).
[0082] Additionally, a hole 9 may be provided through the first wall 2 and the second wall 3 in the second transverse weld zone 67 to allow the bag 1 to be hung on a hook.
[0083] The first longitudinal weld zone 64, the second longitudinal weld zone 65, the first transverse weld zone 66 and the second transverse weld zone 67 are permanent weld zones. That is, these weld zones are obtained by subjecting the first wall 2 and the second wall 3 to a first temperature that fuses the first film and the second film together, so as to obtain a permanent bond of the walls 2 and 3 in these weld zones. The choice of the first temperature depends on the composition of the first film and the second film. The first temperature can be, for example, comprised between 90 and 160 degrees Celsius. In the case of a polypropylene film, the first temperature can be on the order of about 140 to 150 degrees Celsius for 3 seconds.
[0084] In addition, the weld zone 6 also includes a separation weld zone 68 that separates the first compartment 11 from the second compartment 12. That is, the separation weld zone 68 extends between the first compartment 11 and the second compartment 12, preventing the first substance contained in the first compartment 11 from penetrating into the second compartment, and preventing the second substance contained in the second compartment 12 from penetrating into the first compartment 11.
[0085] The first compartment 11 is therefore delimited by the first longitudinal weld zone 64 , the second longitudinal weld zone 65 , the first transverse weld zone 66 and the separating weld zone 68 .
[0086] The second compartment 12 is delimited by a first longitudinal weld zone 64 , a second longitudinal weld zone 65 , a separating weld zone 68 and a second transverse weld zone 67 .
[0087] The separating weld zone 68 is a peelable weld zone. That is, this zone is produced by subjecting the first wall 2 and the second wall 3 to a second temperature that fuses the first film and the second film, the second temperature being lower than the first temperature.
[0088] In this way, the first wall 2 and the second wall 3 are assembled together at the separation weld zone 68, but the assembly obtained is not permanent. Therefore, during use of the bag 1, for example under the influence of pressure exerted on the first compartment 11, the weld can break in this zone.
[0089] The choice of the second temperature depends on the composition of the first film and the second film.The second temperature may for example be comprised between 65 and 145 degrees Celsius.
[0090] like Figure 3 As shown, the separating weld zone 68 extends from the first longitudinal weld zone 64 to the second longitudinal weld zone 65 .
[0091] In addition, the separating weld 68 extends in the transverse direction along the transverse axis X of the bag 1. The transverse axis X extends between the first compartment 11 and the second compartment 12. The first compartment 11 is located on a first side of the transverse axis X, and the second compartment 12 is located on a second side of the transverse axis X opposite to the first side.
[0092] The separating weld zone 68 extends from the first longitudinal weld zone 64 to the second longitudinal weld zone 65 so as to form a first joint 71 between the separating weld zone 68 and the first longitudinal weld zone 64 and a second joint 72 between the separating weld zone 68 and the second longitudinal weld zone 65 .
[0093] In other words, the first joint 71 is where the separating weld zone 68 meets the first longitudinal weld zone 64 , and the second joint 72 is where the separating weld zone 68 meets the second longitudinal weld zone 65 .
[0094] The separating weld zone 68 has a dimension l measured parallel to the transverse axis X between the first joint 71 and the second joint 72 .
[0095] Furthermore, the first compartment 11 has a dimension L measured parallel to the transverse axis X between the first longitudinal weld 64 and the second longitudinal weld 65 .
[0096] The dimension L corresponds to the maximum spacing between the first longitudinal weld 64 and the second longitudinal weld 65 , measured along an axis passing through the first compartment 11 and parallel to the transverse axis X.
[0097] The ratio l / L is comprised in a range extending from 1 / 3 to 3 / 4, preferably in a range extending from 1 / 3 to 2 / 3.
[0098] More precisely, in Figure 3 In the example shown, the ratio l / L is equal to 0.65.
[0099] exist Figure 3 In the example shown, the separation weld zone 68 comprises a central portion 681, a first lateral portion 684 and a second lateral portion 685. The two lateral portions 684 and 685 extend on both sides of the central portion 681. The first lateral portion 684 extends from the central portion 681 to the first longitudinal weld zone 64. The second lateral portion 685 extends from the central portion 681 to the second longitudinal weld zone 65.
[0100] exist Figure 3 In the example shown, the central portion 681 is rectilinear and extends parallel to the transverse axis X of the bag 1 , in other words, it has two edges parallel to the transverse axis X.
[0101] The central portion 681 separating the weld zone 68 has a thickness e1 that is smaller than the thickness e4 , e5 of each of the lateral portions 684 , 685 separating the weld zone 68 .
[0102] More precisely, in Figure 3 In the example shown, the central portion 681 separating the weld zone 68 has a constant thickness e1.
[0103] The first lateral portions 684 separating the weld zones 68 expand from the central portion 681 toward the first longitudinal weld zone 64 .
[0104] Likewise, the second lateral portions 685 separating the weld zones 68 diverge from the central portion 681 toward the second longitudinal weld zone 65 .
[0105] In other words, each lateral portion 684 , 685 has a thickness e4 , e5 that increases continuously from the central portion 681 to the corresponding longitudinal weld zone 64 , 65 .
[0106] More precisely, in Figure 3 In the example shown, each lateral portion 684 , 685 has, on a second side of the transverse axis X, where the second compartment 12 is located, an edge which delimits the second compartment 12 and which forms a non-zero angle with respect to the transverse axis X.
[0107] The first lateral portion 684 expands while forming a first non-zero angle θ4 relative to the transverse axis X.
[0108] The first angle θ4 is included in the range extending from -70° to 0. Preferably, the first angle θ4 is greater than or equal to -50°. Preferably, the first angle θ4 is less than or equal to -20°.
[0109] exist Figure 3 In the example shown, the first angle θ4 is non-zero. More precisely, in this example, the first angle θ4 is equal to -45°.
[0110] Likewise, the second lateral portion 685 expands while forming a second non-zero angle θ5 relative to the transverse axis X. The second angle θ5 is symmetric to the first angle θ4 relative to the longitudinal axis of symmetry.
[0111] Therefore, the second angle θ5 is included in the range extending from 0 to +70°. Preferably, the second angle θ5 is less than or equal to +50°. Preferably, the second angle θ5 is greater than or equal to +20°.
[0112] exist Figure 3 In the example shown, the first angle θ5 is non-zero. More precisely, in this example, the first angle θ5 is equal to +45°.
[0113] Since the thickness e1 of the partition weld zone 68 is smaller than the thicknesses e4 and e5 , the central portion 681 of the partition weld zone constitutes a portion of the partition weld zone 68 where the resistance is reduced.
[0114] Furthermore, the flared shape of the lateral portions 684 , 685 separating the weld zone 68 allows avoiding the presence of corners in the second compartment 12 where the second medicinal substance could accumulate, risking reducing the quality of the mixture or not allowing the bag to be completely emptied.
[0115] Furthermore, the first longitudinal weld zone 64 and the second longitudinal weld zone 65 each comprise a first corresponding portion 641 , 651 delimiting the first compartment 11 and a second corresponding position 642 , 652 delimiting the second compartment 12 .
[0116] The first portion 641 of the first longitudinal weld zone 64 has a first thickness e6, and the second portion 642 of the first longitudinal weld zone 64 has a second thickness e7 that is greater than the first thickness e6.
[0117] Likewise, the first portion 651 of the second longitudinal weld zone 65 has a first thickness e9, and the second portion 652 of the second longitudinal weld zone 65 has a second thickness e10 that is greater than the first thickness e9.
[0118] In addition, if Figure 3 As shown, the first longitudinal weld zone 64 has a joint portion 643 connecting the first portion 641 of the first longitudinal weld zone 64 to the second portion 642. The joint portion 643 expands from the first portion 641 to the second portion 642. The joint portion 643 has a thickness e8 that continuously increases from the first portion 641 of the first longitudinal weld zone 64 to the second portion 642.
[0119] Furthermore, the joining portion 643 connects the first portion 641 to a first end of the separating weld zone 68. The joining portion 643 has an edge 648 which delimits the first compartment 11 and which forms a first angle θ8 with respect to the transverse axis X.
[0120] The first angle θ8 is included in the range extending from 0 to +70°. Preferably, the first angle θ8 is less than or equal to +50°. Preferably, the first angle θ8 is greater than or equal to +20°.
[0121] exist Figure 3 In the example shown, the first angle θ8 is non-zero. More precisely, in this example, the first angle θ8 is equal to +50°.
[0122] Likewise, the second longitudinal weld zone 65 has a joint portion 653 connecting the first portion 651 of the second longitudinal weld zone 65 to the second portion 652. The joint portion 653 expands from the first portion 651 to the second portion 652. The joint portion 653 has a thickness e11 that continuously increases from the first portion 651 to the second portion 652 of the second longitudinal weld zone 65.
[0123] In addition, the joining portion 653 connects the first portion 651 to a second end opposite the first end of the separating weld zone 68. The joining portion 653 has an edge 658 which delimits the first compartment 11 and which forms a second non-zero angle θ11 with respect to the transverse axis X.
[0124] The second angle θ11 is symmetrical to the first angle θ8 with respect to the longitudinal axis of symmetry.
[0125] Therefore, the second angle θ11 is included in the range extending from -70° to 0. Preferably, the second angle θ11 is greater than or equal to -50°. Preferably, the second angle θ11 is less than or equal to -20°.
[0126] exist Figure 3 In the example shown, the second angle θ11 is non-zero. More precisely, in this example, the second angle θ11 is equal to -50°.
[0127] exist Figure 3 In the example shown, each expanded junction portion 643 , 653 therefore has, on a first side of the transverse axis X where the first compartment 11 is located, an edge 648 , 658 which forms a non-zero angle θ8 , θ11 respectively with respect to the transverse axis X.
[0128] On the one hand, the orientation of the edges 648 and 658 of the joining portions 643 and 653 of the first and second longitudinal welds 64 and 65 allows stress to be concentrated on the separating weld zone 68 when pressure P is applied to the first compartment 11, so as to facilitate repeatable and controlled rupture of the separating weld zone 68.
[0129] On the other hand, once the separating weld zone 68 has been broken, this orientation of the edges 648 and 658 of the joining portions 643 and 653 of the first and second longitudinal welds 64 and 65 allows a Venturi effect to be produced, which accelerates the speed of the flow of the first medicinal substance as it penetrates into the second compartment 12.
[0130] Each longitudinal weld zone 64, 65 has a non-welded free zone 644, 654 in its expanded joint portion 643, 653, and each free zone 644, 654 is completely surrounded by the weld.
[0131] Each longitudinal weld zone 64 , 65 also has a non-welded free zone 645 , 655 in its second portion 642 , 652 , each free zone 645 , 655 being completely surrounded by the weld.
[0132] These free areas 644 , 654 , 645 , 655 make it possible to avoid the creation of folds in the polymer film of the walls during the welding together of the first wall 2 and the second wall 3 .
[0133] Figure 4 A bag 1 according to a second embodiment is schematically shown.
[0134] For example, Figure 4 The bag shown may be sized such that the first compartment 11 is suitable for containing approximately 50 ml of a first medicinal substance in liquid form, while the second compartment 12 is suitable for containing approximately 7 g of a second medicinal substance in powder form.
[0135] As in the first embodiment, the first longitudinal weld zone 64 and the second longitudinal weld zone 65 have been obtained by fusing the first wall 2 and the second wall 3 at a first temperature, whereas the separating weld zone 68 has been obtained by fusing the first wall 2 and the second wall 3 at a second temperature lower than the first temperature.
[0136] like Figure 4 As shown, in this second embodiment, the separating weld zone 68 extends parallel to the transverse axis X of the bag 1 .
[0137] The separation weld zone 68 has a straight line shape.
[0138] Furthermore, the separating weld zone 68 has a constant thickness e1 along the transverse axis X.
[0139] The first joining portion 643 connects the first portion 641 to the second portion 642 of the first longitudinal weld zone 64 .
[0140] exist Figure 4 In the example shown, the first longitudinal weld 64 comprises a third joining portion 663 .
[0141] The first joining portion 643 connects the first portion 641 to the third joining portion 663. The third joining portion 663 connects the first joining portion 643 of the first longitudinal weld zone 64 to the second portion 642.
[0142] The first joining portion 643 of the first longitudinal weld 64 expands from the first portion 641 toward the partitioning weld zone 68 .
[0143] The third joining portion 663 narrows from the separation weld zone 68 to the second portion 642 of the first longitudinal weld zone 64 .
[0144] In other words, the joining portion 643 has a thickness e8 that increases continuously from the first portion 641 to the separation weld zone 68 , and the joining portion 663 has a thickness e8 that decreases continuously from the separation weld zone 68 to the second portion 642 of the first longitudinal weld zone 64 .
[0145] Likewise, the second longitudinal weld 65 includes a fourth joining portion 673 .
[0146] The second joining portion 653 connects the first portion 651 to the fourth joining portion 673. The fourth joining portion 673 connects the second joining portion 653 of the second longitudinal weld zone 65 to the second portion 652.
[0147] The second joining portion 653 of the second longitudinal weld 65 expands from the first portion 651 of the second longitudinal weld region 65 toward the partitioning weld region 68 .
[0148] The fourth joining portion 673 narrows from the separation weld zone 68 to the second portion 652 of the second longitudinal weld zone 65 .
[0149] In other words, the joining portion 653 has a thickness e11 that continuously increases from the first portion 651 to the separation weld zone 68 , and the joining portion 673 has a thickness that continuously decreases from the separation weld zone 68 to the second portion 652 .
[0150] The separating weld zone 68 extends from the first longitudinal weld zone 64 to the second longitudinal weld zone 65 so as to form a first joint 71 between the separating weld zone 68 and the first longitudinal weld zone 64 and a second joint 72 between the separating weld zone 68 and the second longitudinal weld zone 65 .
[0151] More precisely, in Figure 4 In the example shown, the separating weld zone 68 extends from the joining portion 643 of the first longitudinal weld 64 to the joining portion 653 of the second longitudinal weld 65 .
[0152] The separating weld zone 68 has a dimension l measured parallel to the transverse axis X between the first joint 71 and the second joint 72 .
[0153] The first compartment 11 has a dimension L measured parallel to the transverse axis X between the first longitudinal weld 64 and the second longitudinal weld 65. The dimension L corresponds to the maximum spacing between the first longitudinal weld 64 and the second longitudinal weld 65, measured along an axis passing through the first compartment 11 and parallel to the transverse axis X.
[0154] The ratio l / L therebetween is included in the range extending from 1 / 3 to 3 / 4, preferably in the range extending from 1 / 3 to 2 / 3.
[0155] More precisely, in Figure 4 In the example shown, the ratio l / L is equal to 0.57.
[0156] The joining portion 643 has an edge 648 which delimits the first compartment 11 and which forms a first angle θ8 with respect to the transverse axis X.
[0157] The first angle θ8 is included in the range extending from 0 to +70°. Preferably, the first angle θ8 is less than or equal to +50°. Preferably, the first angle θ8 is greater than or equal to +20°.
[0158] exist Figure 4 In the example shown, the first angle θ8 is non-zero. More precisely, in this example, the first angle θ8 is equal to +20°.
[0159] Likewise, the joining portion 653 connects the first portion 651 to a second end opposite the first end of the separating weld zone 68. The joining portion 653 has an edge 658 which delimits the first compartment 11 and which forms a second non-zero angle θ11 with respect to the transverse axis X.
[0160] The second angle θ11 is symmetrical to the first angle θ8 with respect to the longitudinal axis of symmetry.
[0161] Therefore, the second angle θ11 is included in the range extending from -70° to 0. Preferably, the second angle θ11 is greater than or equal to -50°. Preferably, the second angle θ11 is less than or equal to -20°.
[0162] exist Figure 4 In the example shown, the second angle θ11 is non-zero. More precisely, in this example, the first angle θ11 is equal to -20°.
[0163] Thus, each engagement portion 643 , 653 has, on a first side of the transverse axis X where the first compartment 11 is located, an edge 648 , 658 which forms a non-zero angle θ8 , θ11 respectively with respect to the transverse axis X.
[0164] Furthermore, the joining portion 643 has a further edge 649 which delimits the second compartment 12 and which forms a third angle θ4 with respect to the transverse axis X.
[0165] The third angle θ4 is included in the range extending from -70° to 0. Preferably, the third angle θ4 is greater than or equal to -50°. Preferably, the third angle θ4 is less than or equal to -20°.
[0166] exist Figure 4 In the example shown, the third angle θ4 is non-zero. More precisely, in this example, the third angle θ4 is equal to -40°.
[0167] Likewise, the joining portion 653 has a further edge 659 which delimits the second compartment 12 and which forms with respect to the transverse axis X a fourth non-zero angle θ5 .
[0168] The fourth angle θ5 is symmetrical to the third angle θ4 with respect to the longitudinal axis of symmetry.
[0169] Therefore, the fourth angle θ4 is included in the range extending from 0 to +70°. Preferably, the fourth angle θ4 is less than or equal to +50°. Preferably, the fourth angle θ4 is greater than or equal to +20°.
[0170] exist Figure 4 In the example shown, the fourth angle θ5 is non-zero. More precisely, in this example, the fourth angle θ5 is equal to +40°.
[0171] Each engagement portion 643 , 653 therefore has, on the second side of the transverse axis X, where the second compartment 11 is located, an edge 649 , 659 which forms a non-zero angle θ4 , θ5 respectively with respect to the transverse axis X.
[0172] Furthermore, each longitudinal weld zone 64 , 65 also includes a joining portion 646 , 656 that expands from the portion 642 , 652 toward the second transverse weld 67 .
[0173] The joining portion 646 of the first longitudinal weld zone 64 has an edge that forms a fifth non-zero angle θ9 with respect to the first longitudinal axis Y1 of the bag 1. The first longitudinal axis Y1 extends parallel to the first edge 14 while passing through the first longitudinal weld zone 64. The joining portion 646 of the first longitudinal weld zone 64 expands toward the side of the first longitudinal axis Y1 where the second compartment 12 is located.
[0174] The fifth angle θ9 is included in the range extending from -70° to 0. Preferably, the fifth angle θ9 is greater than or equal to -50°. Preferably, the fifth angle θ9 is less than or equal to -20°.
[0175] exist Figure 4 In the example shown, the fifth angle θ9 is non-zero. More precisely, in this example, the fifth angle θ9 is equal to -50°.
[0176] Likewise, the joining portion 656 of the second longitudinal weld zone 65 has an edge that forms a sixth non-zero angle θ10 with respect to the second longitudinal axis Y2 of the bag 1. The second longitudinal axis Y2 extends parallel to the second edge 15 while passing through the second longitudinal weld zone 65. The joining portion 656 of the second longitudinal weld zone 65 expands toward the side of the second longitudinal axis Y2 where the second compartment 12 is located.
[0177] The second angle θ10 is symmetrical to the first angle θ9 with respect to the longitudinal axis of symmetry.
[0178] The sixth angle θ10 is included in the range extending from 0 to +70°. Preferably, the sixth angle θ10 is less than or equal to +50°. Preferably, the sixth angle θ10 is greater than or equal to +20°.
[0179] exist Figure 4 In the example shown, the sixth angle θ10 is non-zero. More precisely, in this example, the sixth angle θ10 is equal to +50°.
[0180] The expanded shape of the joining portions 643, 653, 646, 656 of the longitudinal weld zones 64, 65 guides the first medicinal substance to flow into the interior of the second compartment 12 so as to generate a vortex T (as shown by the arrow) inside the second compartment 12. The vortex T improves the efficiency of the mixing between the first substance and the second substance in the second compartment 12. In fact, the vortex is conducive to the circulation of the first medicinal substance in the entire volume of the second compartment 12.
[0181] In addition, each longitudinal weld zone 64, 65 has a non-welded vacant area 644, 654 in its joint portion 643, 653, and each vacant area 644, 654 is completely surrounded by the weld.
[0182] Furthermore, each longitudinal weld zone 64, 65 has a non-welded vacant area 647, 657 in its joint portion 646, 656, and each vacant area 647, 657 is completely surrounded by the weld.
[0183] like Figure 5 As shown, to prepare a medicinal solution using the bag 1 , the first compartment 11 may be manually pressed so as to generate an increased pressure in the first compartment 11 until it causes rupture of the separating weld 68 .
[0184] To this end, the bag 1 can be folded along the transverse axis X and then pressed in the folded position.
[0185] The rupture of the separating weld zone 68 has the effect of placing the first compartment 11 in communication with the second compartment 12 .
[0186] The bag 1 can then be unfolded.
[0187] By continuing to apply pressure to the first compartment 11 , the pressure exerted on the first compartment 11 causes the first medicinal substance to penetrate into the second compartment 12 where it mixes with the second medicinal substance.
[0188] On the one hand, the shape of the joining portions 643 and 653 of the first and second longitudinal welds 64 and 65 allows that when a pressure P (such as Figure 4When the weld is separated from the first compartment 11 (as indicated by the arrow in the first compartment 11), the stress is concentrated on the separation weld zone 68 so as to facilitate repeatable and controlled rupture of the separation weld zone 68.
[0189] On the other hand, once the separating weld 68 has been broken, the shape of the joining portions 643 and 653 of the first and second longitudinal welds 64 and 65 allows a Venturi effect to be generated, which accelerates the flow rate of the first medicinal substance as it penetrates into the second compartment 12 .
[0190] In addition, the expanded shapes of the portions 643, 653, 646, and 656 guide the flow of the first medical substance inside the second compartment 12 so as to form a vortex inside the second compartment 12 (eg, Figure 3 and Figure 4 The eddy current phenomenon improves the efficiency of mixing between the first substance and the second substance. In fact, the eddy current is conducive to the circulation of the first medicinal substance in the entire volume of the second compartment 12.
[0191] Finally, the edges 649 and 659 form a funnel shape that facilitates the flow of the medicinal substance (composed of a mixture of the first medicinal substance and the second medicinal substance) from the second compartment 12 toward the first compartment 11 during administration of the medicinal substance. In other words, the inclined edges 649 and 659 avoid that a portion of the medicinal substance is retained in the second compartment 12 during emptying of the bag.
[0192] Figure 6 A bag 1 according to a third possible embodiment is schematically shown, wherein the bag comprises three compartments.
[0193] In this third embodiment, the first wall 2 and the second wall 3 are assembled together by welding at a plurality of welding zones 6. The welding zones 6 define a first compartment 11, a second compartment 12 and a third compartment 13.
[0194] The first compartment 11 is intended to contain a first medicinal substance, the second compartment 12 is intended to contain a second medicinal substance and the third compartment 13 is intended to contain a third medicinal substance.
[0195] The first medicinal substance is a liquid substance, the second medicinal substance is a powder or a lyophilisate, and the third substance is a liquid substance.
[0196] For example, Figure 6 The bag shown may be sized such that the first compartment 11 is adapted to contain approximately 80 ml of a first medicinal substance in liquid form, the second compartment 12 is adapted to contain approximately 5 grams of a second medicinal substance in powder form, and the third compartment 13 is adapted to contain approximately 20 ml of a third medicinal substance in liquid form.
[0197] The second compartment 12 is separated from the first compartment 11 by the first separation weld 68. That is, the first separation weld 68 extends between the first compartment 11 and the second compartment 12. The first separation weld 68 prevents the first medicinal substance contained in the first compartment 11 from penetrating into the second compartment 12, and prevents the second medicinal substance contained in the second compartment 12 from penetrating into the first compartment 11.
[0198] The third compartment 13 is separated from the first compartment 11 by the second separation weld 69. That is, the second separation weld 69 extends between the first compartment 11 and the third compartment 13. The second separation weld 69 prevents the first medicinal substance contained in the first compartment 11 from penetrating into the third compartment 13, and prevents the third medicinal substance contained in the third compartment 13 from penetrating into the first compartment 11.
[0199] The first dividing weld 68 extends from the first longitudinal weld 64 to the second longitudinal weld 65. The first dividing weld 68 extends in the transverse direction along the transverse axis X of the bag 1. The transverse axis X extends between the first compartment 11 and the second compartment 12. The first compartment 11 is located on a first side of the transverse axis X, and the second compartment 12 is located on a second side of the transverse axis X opposite to the first side.
[0200] The first separating weld 68 extends from the first longitudinal weld 64 to the second longitudinal weld 65 to form a first joint 71 between the separating weld 68 and the first longitudinal weld 64 and a second joint 72 between the separating weld 68 and the second longitudinal weld 65 .
[0201] The separating weld zone 68 has a dimension l measured parallel to the transverse axis X between the first joint 71 and the second joint 72 .
[0202] Furthermore, the first compartment 11 has a dimension L measured between the first 64 and second 65 longitudinal welds parallel to the transverse axis X. The dimension L corresponds to the maximum spacing between the first 64 and second 65 longitudinal welds, measured along the transverse axis X passing through the first compartment 11.
[0203] The ratio l / L therebetween is included in the range extending from 1 / 3 to 3 / 4, preferably in the range extending from 1 / 3 to 2 / 3.
[0204] More precisely, in Figure 6 In the example shown, the ratio l / L is equal to 0.65.
[0205] exist Figure 6In the example shown, the first separating weld zone 68 comprises a central portion 681 and two lateral portions 684 and 685 arranged on either side of the central portion 681. Each lateral portion 684, 685 extends from the central portion 681 to the respective longitudinal weld zone 64, 65.
[0206] exist Figure 6 In the example shown, the central portion 681 of the first separating weld 68 is rectilinear. The central portion 681 extends parallel to the transverse axis X of the bag 1 .
[0207] exist Figure 6 In the example shown, the central portion 681 separating the weld zone 68 has a constant thickness e1.
[0208] Additionally, the thickness e1 of the central portion 681 separating the weld zone 68 is smaller than the thickness e4 , e5 of each of the lateral portions 684 , 685 separating the weld zone 68 .
[0209] Each lateral portion 684, 685 of the first separating weld zone 68 expands while forming a non-zero angle relative to the transverse axis X on both sides of the transverse axis.
[0210] The first lateral portion 684 of the first separating weld zone 68 expands from the central portion 681 toward the first longitudinal weld zone 64 .
[0211] Likewise, the second lateral portion 685 of the first separating weld zone 68 expands from the central portion 681 toward the second longitudinal weld zone 65 .
[0212] In other words, each lateral portion 684 , 685 has a thickness e4 , e5 that increases continuously from the central portion 681 to the corresponding longitudinal weld zone 64 , 65 .
[0213] exist Figure 6 In the example shown, each lateral portion 684, 685 has an edge forming a non-zero angle θ6 relative to the transverse axis X on a first side of the transverse axis where the first compartment 11 is located, and another edge forming a non-zero angle θ7 relative to the transverse axis X on a second side of the transverse axis X where the second compartment 12 is located.
[0214] More precisely, the first lateral portion 684 separating the weld zone 68 expands while forming a first non-zero angle θ6 on a first side of the transverse axis X where the first compartment 11 is located.
[0215] The second lateral portion 685 separating the weld zone 68 expands while forming a second non-zero angle θ7 on the first side of the transverse axis X where the first compartment 11 is located.
[0216] The first lateral portion 684 separating the weld zone 68 expands while forming a third non-zero angle θ4 on a second side of the transverse axis X where the second compartment 12 is located.
[0217] The second lateral portion 685 separating the weld zone 68 expands while forming a fourth non-zero angle θ5 on a second side of the transverse axis X where the second compartment 12 is located.
[0218] In addition, Figure 6 In the illustrated embodiment, the first non-zero angle θ6 is symmetrical to the third non-zero angle θ7 with respect to the longitudinal axis of symmetry. The second non-zero angle θ4 is symmetrical to the fourth non-zero angle θ5 with respect to the longitudinal axis of symmetry.
[0219] Furthermore, the first longitudinal weld zone 64 and the second longitudinal weld zone 65 each comprise a first portion 641 , 651 delimiting the first compartment 11 and a second portion 642 , 652 delimiting the second compartment 12 .
[0220] The first portion 641 of the first longitudinal weld zone 64 has a first thickness e6, and the second portion 642 of the first longitudinal weld zone 64 has a second thickness e7 that is greater than the first thickness e6.
[0221] Likewise, the first portion 651 of the second longitudinal weld zone 65 has a first thickness e9, and the second portion 652 of the second longitudinal weld zone 65 has a second thickness e10 that is greater than the first thickness e9.
[0222] In addition, if Figure 6 As shown, the first longitudinal weld zone 64 has a joint portion 643 connecting the first portion 641 of the first longitudinal weld zone 64 to the second portion 642. The joint portion 643 expands from the first portion 641 to the second portion 642. The joint portion 643 has a thickness e8 that continuously increases from the first portion 641 to the second portion 642 of the first longitudinal weld zone 64.
[0223] Furthermore, the joining portion 643 connects the first portion 641 to a first end of the separating weld zone 68. The joining portion 643 has an edge 648 which delimits the first compartment 11 and which forms a first angle θ8 with respect to the transverse axis X.
[0224] The first angle θ8 is included in the range extending from 0 to +70°. Preferably, the first angle θ8 is less than or equal to +50°. Preferably, the first angle θ8 is greater than or equal to +20°.
[0225] exist Figure 6 In the example shown, the first angle θ8 is non-zero. More precisely, in this example, the first angle θ8 is equal to +50°.
[0226] Likewise, the second longitudinal weld zone 65 has a joint portion 653 connecting the first portion 651 of the second longitudinal weld zone 65 to the second portion 652. The joint portion 653 expands from the first portion 651 to the second portion 652. The joint portion 653 has a thickness e11 that continuously increases from the first portion 651 to the second portion 652 of the second longitudinal weld zone 65.
[0227] In addition, the joining portion 653 connects the first portion 651 to a second end opposite the first end of the separating weld zone 68. The joining portion 653 has an edge 658 which delimits the first compartment 11 and which forms a second non-zero angle θ11 with respect to the transverse axis X.
[0228] The second angle θ11 is symmetrical to the first angle θ8 with respect to the longitudinal axis of symmetry.
[0229] Therefore, the second angle θ11 is included in the range extending from -70° to 0. Preferably, the second angle θ11 is greater than or equal to -50°. Preferably, the second angle θ11 is less than or equal to -20°.
[0230] exist Figure 3 In the example shown, the second angle θ11 is non-zero. More precisely, in this example, the second angle θ11 is equal to -50°.
[0231] exist Figure 6 In the example shown, each expanded engagement portion 643 , 653 has an edge 648 , 658 on a first side of the transverse axis X where the first compartment 11 is located, forming a non-zero angle θ8 , θ11 respectively with respect to the transverse axis X.
[0232] Furthermore, each longitudinal weld zone 64, 65 has a non-welded vacant area 644, 654 in its expanded joint portion 643, 653, and each vacant area 644, 654 is completely surrounded by the weld.
[0233] Each longitudinal weld zone 64 , 65 also has a non-welded free zone 645 , 655 in its second portion 642 , 652 , each free zone 645 , 655 being completely surrounded by the weld.
[0234] The free areas 644 , 654 , 645 , 655 allow avoiding the creation of folds in the polymer film of the walls during welding of the first wall 2 and the second wall 3 together.
[0235] The second separating weld zone 69 extends from the first transverse weld zone 66 to the second longitudinal weld zone 65 .
[0236] The second separating weld zone 69 has a thickness e12 that is substantially constant from the first transverse weld zone 66 to the second longitudinal weld zone 65 .
[0237] The second separation weld zone 69 includes a first portion 691 extending from the first transverse weld zone 66, a second portion 692 extending to the second longitudinal weld zone 65, and a third portion 693 connecting the first portion 691 and the second portion 692 together. The first portion 691 has a substantially straight shape. The second portion 692 also has a substantially straight shape. The third portion 693 has a curved shape. More specifically, the third portion 693 has a curvature including a convex side and a concave side, the first compartment 11 is located on the convex side of the curvature, and the third compartment 13 is located on the concave side of the curvature.
[0238] The second separating weld 69 is also a peelable weld.
[0239] The bag 1 further comprises a first filling tube 4 and a second filling tube 10 .
[0240] The first filling tube 4 is arranged between the first wall 2 and the second wall 3 through the first transverse weld zone 65 in order to allow filling of the first compartment 11 with the first medicinal substance via the first filling tube 4 .
[0241] The second filling tube 10 is arranged between the first wall 2 and the second wall 3 through the first transverse weld zone 65 in order to allow filling of the third compartment 13 with a third medicinal substance via the second filling tube 10 .
[0242] Once the first compartment 11 has been filled with the first medicinal substance, the first filling tube 4 may be permanently closed (eg by a stopper or welding).
[0243] Once the third compartment 13 has been filled with the third medicinal substance, the second filling tube 10 can be blocked by the connector.
[0244] Figure 7 A bag 1 according to a fourth possible embodiment is schematically shown.
[0245] For example, Figure 7 The bag shown may be sized such that the first compartment 11 is suitable for containing approximately 40 ml of a first medicinal substance in liquid form, the second compartment 12 is suitable for containing approximately 100 grams of a second medicinal substance in powder form, and the third compartment 13 is suitable for containing approximately 10 ml of a third medicinal substance in liquid form.
[0246] In addition to compartments 11, 12 and 13 having different contents, Figure 7 The intravenous infusion bag 1 shown has Figure 6 Same features as the IV infusion bag shown.
[0247] The first separating weld 68 extends from the first longitudinal weld 64 to the second longitudinal weld 65 to form a first joint 71 between the separating weld 68 and the first longitudinal weld 64 and a second joint 72 between the separating weld 68 and the second longitudinal weld 65 .
[0248] The separating weld zone 68 has a dimension l measured parallel to the transverse axis X between the first joint 71 and the second joint 72 .
[0249] Furthermore, the dimension L is measured between the first permanent weld 64 and the second permanent weld 65 along an axis parallel to the transverse axis X and passing through the first compartment 11 .
[0250] This dimension L corresponds to the maximum spacing between the first longitudinal weld 64 and the second longitudinal weld 65 , measured along the transverse axis X passing through the first compartment 11 .
[0251] exist Figure 7 In the example shown, an axis parallel to the transverse axis X passes through the first compartment 11 and through the third compartment 13 .
[0252] The ratio l / L is included in the range extending from 1 / 3 to 3 / 4.
[0253] The ratio l / L therebetween is included in the range extending from 1 / 3 to 3 / 4, preferably in the range extending from 1 / 3 to 2 / 3.
[0254] More precisely, in Figure 7 In the example shown, the ratio l / L is equal to 0.65.
[0255] To prepare a medicinal solution using the bag 1 , the third compartment 13 may be manually pressed in order to create an increased pressure in the third compartment 13 until it causes rupture of the third dividing weld 69 .
[0256] Rupture of the second dividing weld 69 has the effect of placing the third compartment 13 in communication with the first compartment 11 .
[0257] In other words, once the second dividing weld 69 is broken, the two compartments 11 and 13 then form an identical single compartment 11 + 13 containing a mixture of the first medicinal substance and the third medicinal substance.
[0258] Thus, in continuation of the preparation method, the bag 1 can be used like a bag with two compartments.
[0259] According to a second step, the compartment containing the mixture can be pressed manually in order to generate an increased pressure in the compartments 11 + 13 until it causes a rupture of the separating weld zone 68 .
[0260] To this end, the bag 1 can be folded along the transverse axis X and then pressed in the folded position.
[0261] The rupture of the first dividing weld 68 has the effect of placing the compartment 11+13 in communication with the second compartment 12 .
[0262] The bag 1 can then be unfolded.
[0263] By continuing to apply pressure to the compartments 11+13, the pressure applied to the compartments 11+13 causes the first medicinal substance to penetrate into the second compartment 12, where the mixture of the first medicinal substance and the second medicinal substance is mixed with the third medicinal substance.
[0264] Example:
[0265] Several bags 1 were tested with the parameters mentioned in Table 1.
[0266] Each bag tested comprised a first compartment 11 containing approximately 100 ml of a first liquid substance and a second compartment containing approximately 5 g of a second solid substance in powder form.
[0267] The first compartment 11 is pressed so as to increase the pressure of the first substance contained in the first compartment 11 by approximately 0.6 bar.
[0268] The presence of a "dead zone" indicates that there is powder that has not mixed with the liquid in the second compartment 12. This indicates that the mixing is not effective enough.
[0269] The extent of the rupture of the peelable weld is observed to determine whether the rupture is sufficient to allow adequate liquid flow from the first compartment 11 to the second compartment 12.
[0270] Estimate the head loss of the liquid flow penetrating into the second compartment 12. Too large a head loss will prevent the liquid from penetrating into the second compartment at a sufficient flow rate, making it difficult to ensure a good mixing effect between the liquid and the powder.
[0271] [Table 1]:
[0272]
[0273] When the ratio l / L is less than or equal to 3 / 4, the stress distribution in the peelable weld zone is sufficiently uniform. This uniform distribution allows complete rupture of the peelable weld zone to be obtained.
[0274] On the contrary, when the ratio l / L becomes greater than 3 / 4, the stress applied to the peelable weld zone is no longer evenly distributed along the peelable weld zone. In this case, the rupture of the peelable weld zone is incomplete, which does not allow accurate control of the rupture position and causes a huge head loss of the liquid flow penetrating into the second compartment 12.
[0275] On the other hand, a ratio l / L of less than 1 / 3 has the effect that the peelable weld becomes difficult to rupture. In this case, the extent of rupture of the peelable weld may also be incomplete, which does not allow the first medicinal substance that penetrates into the second compartment to generate a flow rate sufficient to ensure complete and uniform mixing with the second medicinal substance.
[0276] Furthermore, the presence of non-zero angles θ8 and θ11 allows directing the flow of the liquid and thus reducing the head losses generated by the liquid flowing through the opening formed in the peelable weld into the third compartment.
[0277] However, values of the angle θ8 that are too high (greater than +70°) have the effect of counteracting the benefits brought by a ratio l / L that is less than or equal to 3 / 4.
Claims
1. A bag (1) intended to contain a medicinal substance for intravenous injection, the bag comprising: - a first wall (2), and - a second wall (3), The first wall (2) and the second wall (3) are assembled together by a weld zone (6), the weld zone (6) defining at least one first compartment (11) intended to contain a first medicinal substance and at least one second compartment (12) intended to contain a second medicinal substance, Wherein, the welding zone (6) comprises: - a first permanent weld zone (64) extending along a first longitudinal edge (14) of the bag (1), - a second permanent weld zone (65) extending along a second longitudinal edge (15) of the bag (1) opposite the first longitudinal edge (14), and - a third peelable weld (68) which separates said first compartment (11) from said second compartment (12), wherein the third peelable weld zone (68) extends from the first permanent weld zone (64) to the second permanent weld zone (65) so as to form a first joint (71) between the third peelable weld zone (68) and the first permanent weld zone (64), and a second joint (72) between the third peelable weld zone (68) and the second permanent weld zone (65), And wherein, the ratio l / L between the dimension l of the third peelable weld zone (68) measured along the transverse axis (X) between the first joint (71) and the second joint (72) and the dimension L measured along an axis parallel to the transverse axis (X) and passing through the first compartment (11) between the first permanent weld (64) and the second permanent weld (65) is included in the range extending from 1 / 3 to 3 / 4.
2. The bag (1) according to claim 1, wherein: The ratio l / L is included in the range extending from 1 / 3 to 2 / 3.
3. The bag (1) according to one of claims 1 and 2, wherein: The first permanent weld zone (64) includes a first longitudinal portion (641) extending parallel to the first longitudinal edge (14) of the bag (1) and a first expansion portion (643) extending from the first longitudinal portion (641) to the first joint (71), the first expansion portion (643) defining the first compartment (11) by forming a first angle (θ8) with a transverse axis (X) extending perpendicular to the longitudinal edges (14, 15) and included in the range extending from 0° to +70°, and the second permanent weld zone (65) includes a second longitudinal portion (651) extending parallel to the second longitudinal edge (15) of the bag (1) and a second expansion portion (653) extending from the second longitudinal portion (651) to the second joint (72), the second expansion portion (653) defining the first compartment (11) by forming a second angle (θ11) with the transverse axis and included in the range extending from -70° to 0°.
4. The bag according to claim 3, wherein: The first angle (θ8) is included in a range extending from 0° to +50° relative to the transverse axis (X), and the second angle (θ11) is included in a range extending from -50° to 0° relative to the transverse axis (X).
5. The bag according to one of claims 3 and 4, wherein The first angle (θ8) is included in a range extending from +20° to +50° relative to the transverse axis, and the second angle (θ11) is included in a range extending from -50° to -20° relative to the transverse axis (X).
6. The bag according to one of claims 1 to 5, wherein The first permanent weld zone (64) includes a third longitudinal portion (642) extending parallel to the first longitudinal edge (14) of the bag (1) and a third expansion portion (663) extending from the third longitudinal portion (642) to the first joint (71), the third expansion portion (663) defining the second compartment (12) by forming a third angle (θ4) with a transverse axis (X) extending perpendicular to the longitudinal edges (14, 15) and included in the range extending from -70° to 0°, and the second permanent weld zone (65) includes a fourth longitudinal portion (652) extending parallel to the second longitudinal edge (15) of the bag (1) and a fourth expansion portion (673) extending from the fourth longitudinal portion (652) to the second joint (72), the fourth expansion portion (673) defining the second compartment (12) by forming a fourth angle (θ5) with the transverse axis and included in the range extending from 0° to +70°.
7. The bag according to claim 6, wherein: The third angle (θ4) is included in the range extending from -50° to 0° relative to the transverse axis (X), and the fourth angle (θ5) is included in the range extending from 0° to +50° relative to the transverse axis.
8. The bag according to one of claims 6 and 7, wherein The third angle (θ4) is included in a range extending from -50° to -20° relative to the transverse axis, and the fourth angle (θ5) is included in a range extending from +20° to +50° relative to the transverse axis.
9. Bag according to one of claims 1 to 8, wherein: - the first permanent weld zone (64) and the second permanent weld zone (65) have been obtained by fusing the first wall (2) and the second wall (3) at a first temperature, and - said third peelable weld (68) has been obtained by fusing said first wall (2) and said second wall (3) at a second temperature lower than said first temperature, So that when the first medicinal substance is received in the first compartment (11) and pressure is applied to the first compartment (11), the pressure applied to the first compartment (11) causes rupture of the third peelable weld area (68), thereby allowing the first medicinal substance to penetrate into the second compartment (12).
10. The bag according to one of claims 1 to 9, comprising a first medicinal substance contained in the first compartment (11).
11. The bag according to claim 10, wherein: The first medicinal substance is a liquid substance.
12. The bag according to one of claims 1 to 11, comprising a second medicinal substance contained in the second compartment (12).
13. The bag according to claim 12, wherein: The second medicinal substance is a powder or a lyophilized agent.
14. A method for preparing a medicinal solution using a bag (1) according to one of claims 1 to 13, wherein: The first compartment (11) of the bag (1) contains a first medicinal substance, and the second compartment (12) of the bag (1) contains a second medicinal substance, the method comprising the following steps: - pressing said first compartment (11) so as to cause rupture of said third peelable weld (68), thus allowing said first medicinal substance to penetrate into said second compartment (12).
15. A method for manufacturing a bag (1), comprising the following steps: - welding the first wall (2) and the second wall (3) together at a welding zone (6), said welding zone (6) defining at least one first compartment (11) intended to receive a first medicinal substance and at least one second compartment (12) intended to receive a second medicinal substance, and Wherein, the welding zone (6) comprises: - a first permanent weld zone (64) extending along a first longitudinal edge (14) of the bag (1), - a second permanent weld zone (65) extending along a second longitudinal edge (15) of the bag (1) opposite the first longitudinal edge, and - a third peelable weld (68) which separates said first compartment (11) from said second compartment (12), wherein the third peelable weld zone (68) extends from the first permanent weld zone (64) to the second permanent weld zone (65) so as to form a first joint (71) between the third peelable weld zone (68) and the first permanent weld zone (64), and a second joint (72) between the third peelable weld zone (68) and the second permanent weld zone (65), And wherein, a ratio l / L between a dimension l of the third peelable weld zone (68) measured between the first joint (71) and the second joint (72) and a dimension L of the first compartment (11) measured between the first permanent weld (64) and the second permanent weld (65) is included in a range extending from 1 / 3 to 3 / 4.
16. The method according to claim 15, wherein: The step of welding the first wall (2) and the second wall (3) together comprises: - welding the first wall (2) and the second wall (3) at the first permanent weld zone (64) and the second permanent weld zone (65) by fusing the first wall (2) and the second wall (3) at a first temperature, and - Welding the first wall (2) and the second wall (3) together at the third peelable weld area (68) by fusing the first wall (2) and the second wall (3) at a second temperature lower than the first temperature.
