A bag for holding medical substances for intravenous injection
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-03-23
- Publication Date
- 2026-03-06
AI Technical Summary
When mixing the medical quality of existing medical bags, the crack control is poor, resulting in incomplete mixing and the dosage cannot be guaranteed to meet the requirements.
A medical bag is designed which includes a first permanent welding area, a second permanent welding area and a tearable welding area. The tear-weldable area extends from the first permanent welding area to the second permanent welding area, forming a specific connection point, and controlling the position and degree of fracture by adjusting the proportion of the welding area.
By adjusting the ratio of tearable welding area to the permanent welding area, controllability and integrity of the mixing of medical substances is achieved, ensuring the uniformity of the drug and dose accuracy after mixing.
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Abstract
Description
[Technical field]
[0001] The present invention relates to a bag for containing medical substances for intravenous injection, a method for preparing a medicinal solution using such a bag, and a method for manufacturing such a bag. [Background technology]
[0002] Bags for containing medical fluids for intravenous injection (e.g., medicines, solutes, physiological solutions, blood-derived products, etc.) are flexible bags that can be connected to tubing for parenteral administration of the medical fluids to a patient, or from which the medical fluids can be extracted with a syringe for administration to a patient.
[0003] These bags are typically manufactured by welding two flexible films of polymeric material together.
[0004] These bags can be sterilized by irradiation prior to aseptic filling and / or by autoclaving after filling.
[0005] French patent application FR 3058638 describes a medical bag made of two transparent films and including 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 has a permanently welded area on the periphery of the bag and a peelable welded area between the two compartments. The peelable welded area is configured to be broken at the moment the bag is used to put the first and second compartments in communication in order to mix the first and second compounds immediately before administration to the patient.
[0006] Such bags allow the packaging of highly unstable medical substances that cannot be stored in a mixed state and must be mixed to reconstitute the drug solution immediately prior to administration to a patient.
[0007] One problem with these bags is that the rupture of the peelable weld areas is not always well controlled.
[0008] However, depending on the location and extent of the break in the peelable weld, the first compound may not be mixed throughout the entire volume of the second compartment, resulting in incomplete mixing of the two compounds and making it difficult to ensure compliance with the prescribed dosage.
[0009] Furthermore, during administration of the medical substance, the two films may come into contact, creating stagnation areas and preventing the bag from emptying completely, which means that the patient does not receive the full amount of medical substance. Summary of the Invention
[0010] One of the aims is to propose a bag for containing medical substances for intravenous injection, which allows a better control of the mixing of the two medical substances.
[0011] The object is to provide a bag for intravenous medical substances, A first wall portion; a second wall portion, the first wall and the second wall are assembled together by a welded area, the welded area defining at least one first compartment intended to contain a first medical substance and at least one second compartment intended to contain a second medical substance; The welding area is a first permanently welded area extending along a first longitudinal edge of the bag; a second permanently welded region extending along a second longitudinal edge of the bag opposite the first longitudinal edge; a third peelable weld area separating the first section and the second section; the third peelable weld region extends from the first permanent weld region to the second permanent weld region such that a first connection is formed between the third peelable weld region and the first permanent weld region and a second connection is formed between the third peelable weld region and the second permanent weld region; The ratio l / L of the dimension l of the third peelable welded area measured between the first and second connection along the horizontal axis to the dimension L measured between the first and second permanently welded areas along an axis parallel to the horizontal axis and passing through the first compartment is achieved by the bag in the range of 1 / 3 to 3 / 4.
[0012] The particular dimensional ratio between the third peelable welded area and the spacing between the two permanently welded areas allows the location where the break occurs and the extent of the break to be reproducibly controlled.
[0013] Indeed, it has been observed that when the ratio l / L is less than 1 / 3, the third peelable welded area is difficult to break, and the degree of breakage of the third peelable welded area is insufficient to allow a sufficient flow rate of the first medical substance to penetrate into the second compartment and ensure a complete and homogeneous mixing with the second medical substance.
[0014] If the ratio l / L is greater than 3 / 4, the stress acting on the third peelable welded area will not be distributed homogeneously along the third peelable welded area, in which case the location at which the breakage of the third peelable welded area occurs cannot be precisely controlled, and the flow of the first medical substance penetrating the second compartment cannot be favorably positioned to ensure complete and homogeneous mixing with the second medical substance.
[0015] On the other hand, if the ratio l / L is in the range of 1 / 3-3 / 4, as proposed, it is possible to control both the direction and the intensity of the flow of the first medical substance penetrating into the second compartment without exerting excessive pressure on the first compartment, thus allowing a complete and homogeneous mixture of the two substances to be obtained in a reproducible manner.
[0016] The bag may also have the following features:
[0017] The ratio l / L is in the range of 1 / 3 to 2 / 3.
[0018] The first permanently welded region includes a first longitudinal portion extending parallel to a first longitudinal edge of the bag and a first flared portion extending from the first longitudinal portion to a first junction, the first flared portion defining a first compartment at a first angle in the range of 0° to +70° relative to a transverse axis extending perpendicular to the longitudinal edge. The second permanently welded region includes a second longitudinal portion extending parallel to a second longitudinal edge of the bag and a second flared portion extending from the second longitudinal portion to a second junction, the second flared portion defining a first compartment at a second angle in the range of -70° to 0° relative to the transverse axis.
[0019] The first angle is in the range of 0° to +50° with respect to the horizontal axis, and the second angle is in the range of −50° to 0° with respect to the horizontal axis.
[0020] The first angle is in the range of +20° to +50° with respect to the horizontal axis, and the second angle is in the range of −50° to −20° with respect to the horizontal axis.
[0021] The first permanently welded region includes a third longitudinal portion extending parallel to the first longitudinal edge of the bag and a third flared portion extending from the third longitudinal portion to the first junction, the third flared portion defining a second compartment at a third angle ranging from -70° to 0° relative to a horizontal axis extending perpendicular to the longitudinal edges. The second permanently welded region includes a fourth longitudinal portion extending parallel to the second longitudinal edge of the bag and a fourth flared portion extending from the fourth longitudinal portion to the second junction, the fourth flared portion defining a second compartment at a fourth angle ranging from 0° to +70° relative to the horizontal axis.
[0022] The third angle is in the range of −50° to 0° with respect to the horizontal axis, and the fourth angle is in the range of 0° to +50° with respect to the horizontal axis.
[0023] The third angle is in the range of −50° to −20° with respect to the horizontal axis, and the fourth angle is in the range of +20° to +50° with respect to the horizontal axis.
[0024] The first and second permanently welded regions are obtained by melting the first and second wall portions at a first temperature, and the third peelable welded region is obtained by melting the first and second wall portions at a second temperature lower than the first temperature, and when a first medical substance is placed in the first compartment and pressure is applied to the first compartment, the pressure acting on the first compartment causes the third peelable welded region to rupture, allowing the first medical substance to enter the second compartment.
[0025] The bag includes a first medical substance contained in a first compartment.
[0026] The first medical substance is a liquid substance.
[0027] The bag includes a second medical substance contained in a second compartment.
[0028] The second medical substance is a powder or a lyophilisate.
[0029] A medicinal solution can be prepared by the method of preparing a medicinal solution using the above-mentioned bag, the first compartment of the bag containing a first medical substance and the second compartment of the bag containing a second medical substance, the method comprising the steps of pressing the first compartment to cause rupture of the third peelable weld region, thereby allowing the first medical substance to enter the second compartment.
[0030] The bag described above can be produced by a method comprising the steps of welding a first wall and a second wall at a welding region, the method comprising the steps of: the welded area defines at least one first compartment intended to contain a first medical substance and at least one second compartment intended to contain a second medical substance; The welding area is a first permanently welded area extending along a first longitudinal edge of the bag; a second permanently welded region extending along a second longitudinal edge of the bag opposite the first longitudinal edge; a third peelable weld area separating the first section and the second section; the third peelable weld region extends from the first permanent weld region to the second permanent weld region such that a first connection is formed between the third peelable weld region and the first permanent weld region and a second connection is formed between the third peelable weld region and the second permanent weld region; The third peelable welded region can be manufactured by a method in which the ratio l / L of the dimension l of the third peelable welded region measured between the first connection portion and the second connection portion to the dimension L of the first section measured between the first permanent welded region and the second permanent welded region is in the range of 1 / 3 to 3 / 4.
[0031] The step of welding the first wall portion and the second wall portion includes: melting the first wall portion and the second wall portion at a first temperature to fuse the first wall portion and the second wall portion together at a first permanently welded region and a second permanently welded region; and fusing the first wall portion and the second wall portion at a third peelable weld area by melting the first wall portion and the second wall portion at a second temperature lower than the first temperature.
[0032] Other features and advantages will become apparent from the following description, which is given by way of example only and is not limiting, and which is to be read in conjunction with the accompanying drawings, in which: [Brief description of the drawings]
[0033] [Figure 1] FIG. 1 is a front view of a bag for containing medical substances for intravenous injection. [Diagram 2] FIG. 2 is a rear view of the bag of FIG. 1. [Diagram 3] FIG. 1 is a schematic view of a bag for containing medical substances for intravenous injection according to a first embodiment before filling. [Figure 4] FIG. 2 is a schematic view of a bag for containing medical substances for intravenous injection according to a second embodiment before filling. [Diagram 5] FIG. 10 is a schematic diagram showing steps for preparing a medicinal solution using a bag. [Figure 6]FIG. 2 is a schematic view of a bag for containing medical substances for intravenous injection according to a third embodiment before filling. [Figure 7] FIG. 13 is a schematic view of a bag for containing medical substances for intravenous injection according to a fourth embodiment before filling. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0034] 1 and 2, the bag 1 includes a first wall 2, a second wall 3, a filling tube 4, and a connector 5.
[0035] The first wall 2 and the second wall 3 are assembled together by being heat welded at a number of welded areas 6. The welded areas 6 define between the first wall 2 and the second wall 3 a first compartment 11 and a second compartment 12 separated from the first compartment 11.
[0036] The first compartment 11 contains a first medical substance and the second compartment 12 contains a second medical substance.
[0037] In the example shown in Fig. 1, the first medical substance is a liquid substance and the second medical substance is a powdered substance or a lyophilisate. The powdered substance or the lyophilisate comprises for example an active ingredient (such as an antibiotic, an anticancer agent, an antifungal agent or a blood derivative) and the liquid substance is for example a diluent suitable for diluting the powdered substance or the lyophilisate. The liquid substance and the powdered substance (or the lyophilisate) are intended to be mixed to prepare the medical solution immediately before administering the medical solution to a patient.
[0038] The first wall 2 may be formed from a first film of a polymeric material, for example a polymeric material including a polyolefin such as polypropylene or polyethylene.
[0039] Similarly, the second wall 3 can be formed from a second film identical to the first film. The second wall can be formed from a second film of a polymer material, for example a polymer material including a polyolefin such as polypropylene or polyethylene.
[0040] The filling tube 4 is disposed between the first wall 2 and the second wall 3 such that the first compartment 11 can be filled with a first medical substance via the filling tube 4. More specifically, the filling tube 4 has a first end having a first opening leading to the first compartment 11 and a second end opposite the first end having a second opening leading to the outside of the first compartment 11. That is, the second opening leads to the outside of the bag 1. The filling tube 4 also has an internal flow path extending from the first opening to the second opening.
[0041] The connector 5 seals the second opening of the filling tube 4. The connector 5 has a detachable portion 51 that can be torn off. When torn off, the detachable portion 51 separates from the remainder of the connector 5, allowing a needle to be inserted into the connector 5, for example, to connect the filling tube 4 of the bag 1 to an intravenous infusion device or syringe.
[0042] As shown in FIG. 1, the bag 1 may further include a first protective sheet 7 attached to the first wall portion 2 and / or a second protective sheet 8 attached to the second wall portion 3.
[0043] The first protective sheet 7 covers the outer surface of the first wall 2 so as to mask the second compartment 12, but not the first compartment 11. Similarly, the second protective sheet 8 covers the outer surface of the second wall 3 so as to mask the second compartment 12, but not the first compartment 11.
[0044] The first protective sheet 7 and the second protective sheet 8 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 medical substance.
[0045] Therefore, the first protective sheet 7 and the second protective sheet 8 can each be composed of an aluminum layer or a composite layer containing aluminum.
[0046] 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 welding, which allows the first protective sheet 7 and / or the second protective sheet 8 to be removed before use of the bag. By removing the first protective sheet 7 and / or the second protective sheet 8, the condition of the second medical substance contained in the second compartment 12 can be visually checked before mixing the first medical substance with the second medical substance.
[0047] 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 use of the bag. The first protective sheet 7 and / or the second protective sheet 8 may be transparent to visible light so as to allow visual confirmation of the state of the second medical substance contained in the second compartment 12.
[0048] The bag 1 may further have an opening 9 extending through both the first wall 2 and the second wall 3 in the welded area, allowing the bag 1 to be hung from a hook during use.
[0049] When the bag 1 is hung on the hook, the second compartment 12 is located above the first compartment 11 and the filling tube 4 extends vertically downwards.
[0050] FIG. 3 shows diagrammatically a bag 1 according to a first embodiment.
[0051] As an example, the bag 1 shown in Figure 3 may be dimensioned such that the first compartment 11 is suitable for containing approximately 250 milliliters of a first medical substance in liquid form and the second compartment 12 is suitable for containing a few milligrams to several hundred grams, for example 100 grams, of a second medical substance in powder form.
[0052] The bag 1 shown in FIG. 3 has 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.
[0053] The bag 1 further includes a plurality of welded regions 6 that define a first compartment 11 and a second compartment 12 .
[0054] More specifically, the welded area 6 includes a first longitudinal welded area 64 extending along the first longitudinal edge 14 and a second longitudinal welded area 65 extending along the second longitudinal edge 15 .
[0055] Additionally, the weld region 6 further includes a first lateral weld region 66 extending along the first lateral edge 16 .
[0056] In Fig. 3 the bag 1 is shown before filling, i.e. the first compartment 11 does not yet contain a first medical substance and the second compartment does not yet contain a second medical substance. Therefore the welded area 6 does not yet include a second transverse welded area extending along the second lateral edge 17. The second medical substance can therefore be introduced into the second compartment 12 via an opening that exists between the first wall 2 and the second wall 3 that are not welded along the second lateral edge 17.
[0057] However, when the second compartment 12 is filled with a second medical substance, a second lateral weld region 67 can be formed extending along the second lateral edge 17 (the second lateral weld region 67 is shown by a dotted line in FIG. 3).
[0058] Additionally, an opening 9 may be provided in the second lateral weld area 67 through both the first wall 2 and the second wall 3 to allow the bag 1 to be hung on a hook.
[0059] The first longitudinal welded area 64, the second longitudinal welded area 65, the first transverse welded area 66 and the second transverse welded area 67 are permanently welded areas. That is to say, these welded areas are obtained by subjecting the first wall 2 and the second wall 3 to a first temperature which causes melting of the first and second films, thereby obtaining a permanent bond of the walls 2, 3 in these welded areas. The choice of the first temperature depends on the composition of the first and second films. The first temperature can be, for example, 90-160°C. In the case of a polypropylene film, the first temperature can be about 140-150°C for about 3 seconds.
[0060] Additionally, the welded region 6 further includes a separate welded region 68 that separates the first compartment 11 from the second compartment 12. That is, the separate welded region 68 extends between the first compartment 11 and the second compartment 12, preventing a first substance contained in the first compartment 11 from penetrating into the second compartment and preventing a second substance contained in the second compartment 12 from penetrating into the first compartment 11.
[0061] Thus, first compartment 11 is defined by a first longitudinal weld region 64 , a second longitudinal weld region 65 , a first transverse weld region 66 , and a separate weld region 68 .
[0062] The second section 12 is defined by a first longitudinal welded region 64 , a second longitudinal welded region 65 , a separating welded region 68 , and a second transverse welded region 67 .
[0063] The separated weld region 68 is a peelable weld region, i.e., it is created by subjecting the first wall 2 and the second wall 3 to a second temperature, lower than the first temperature, which causes melting of the first and second films.
[0064] In this way, the first wall 2 and the second wall 3 are joined at the separate weld area 68, but the resulting joint is not permanent and can therefore be subjected to pressure, for example on the first compartment 11, during use of the bag 1, causing the weld to rupture in this area.
[0065] The selection of the second temperature depends on the compositions of the first film and the second film. The second temperature can be, for example, 65 to 145°C.
[0066] As shown in FIG. 3, the separate weld region 68 extends from the first longitudinal weld region 64 to the second longitudinal weld region 65 .
[0067] The separate welded region 68 also extends laterally 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 one side of the transverse axis X, and the second compartment 12 is located on the other side of the transverse axis X, opposite the first side.
[0068] The separate welded region 68 extends from the first longitudinal welded region 64 to the second longitudinal welded region 65 such that a first connection 71 is formed between the separate welded region 68 and the first longitudinal welded region 64 and a second connection 72 is formed between the separate welded region 68 and the second longitudinal welded region 65.
[0069] In other words, the first connection 71 is where the separate weld region 68 meets the first longitudinal weld region 64 and the second connection 72 is where the separate weld region 68 meets the second longitudinal weld region 65 .
[0070] The separate weld region 68 has a dimension 1 measured parallel to the transverse axis X between the first connection portion 71 and the second connection portion 72 .
[0071] The first section 11 also has a dimension L measured parallel to the transverse axis X between the first longitudinal welded area 64 and the second longitudinal welded area 65 .
[0072] The dimension L corresponds to the maximum spacing between the first longitudinal welded region 64 and the second longitudinal welded region 65 measured along an axis passing through the first section 11 and parallel to the transverse axis X.
[0073] The ratio l / L is in the range of 1 / 3 to 3 / 4, preferably in the range of 1 / 3 to 2 / 3.
[0074] More specifically, in the example of FIG. 3, the ratio l / L is 0.65.
[0075] 3, the separate welded region 68 consists of a central portion 681, a first side portion 684, and a second side portion 685. The two side portions 684 and 685 extend on either side of the central portion 681. The first side portion 684 extends from the central portion 681 to the first longitudinal welded region 64. The second side portion 685 extends from the central portion 681 to the second longitudinal welded region 65.
[0076] 3, the central portion 681 is straight and extends parallel to the transverse axis X of the bag 1. In other words, the central portion 681 has two edges parallel to the transverse axis X.
[0077] The central portion 681 of the separated welded region 68 has a thickness e 1 that is less than the thicknesses e 4 , e 5 of each of the side portions 684 , 685 of the separated welded region 68 .
[0078] More specifically, in the example shown in FIG. 3, a central portion 681 of the separate welded region 68 has a constant thickness e1.
[0079] A first lateral portion 684 of the separate weld region 68 extends from the central portion 681 toward the first longitudinal weld region 64 .
[0080] Similarly, the second lateral portion 685 of the separate weld region 68 extends from the central portion 681 towards the second longitudinal weld region 65 .
[0081] In other words, each side portion 684,685 has a thickness e4,e5 that increases continuously from the central portion 681 to each longitudinal weld region 64,65.
[0082] More specifically, in the example shown in FIG. 3, each lateral portion 684, 685 defines the second section 12 on the other side of the horizontal axis X on which the second section 12 is located and has an edge that forms a non-zero angle with respect to the horizontal axis X.
[0083] The first lateral portion 684 flares at a first non-zero angle θ 4 relative to the transverse axis X.
[0084] The first angle θ4 is in the range of −70° to 0°. Preferably, the first angle θ4 is −50° or more. Preferably, the first angle θ4 is −20° or less.
[0085] In the example of Figure 3, the first angle θ4 is not zero. More specifically, in this example, the first angle θ4 is -45°.
[0086] Similarly, the second lateral portion 685 flares at a second non-zero angle θ5 relative to the horizontal axis X. The second angle θ5 is symmetrical to the first angle θ4 relative to the longitudinal axis of symmetry.
[0087] Therefore, the second angle θ5 is in the range of 0° to +70°. Preferably, the second angle θ5 is +50° or less. Preferably, the second angle θ5 is +20° or more.
[0088] In the example of Figure 3, the first angle θ5 is not zero. More specifically, in this example, the first angle θ5 is +45°.
[0089] Since thickness e1 is less than thicknesses e4 and e5, central portion 681 of separated weld region 68 constitutes the less resistive portion of separated weld region 68.
[0090] Additionally, the flared shape of the side portions 684, 685 of the separate welded area 68 eliminates any corners in the second compartment 12 where the second medical substance could accumulate, compromising the quality of the mixture or preventing the bag from being completely emptied.
[0091] Additionally, the first longitudinal welded region 64 and the second longitudinal welded region 65 each include a first portion 641, 651 that defines the first compartment 11 and a second portion 642, 652 that defines the second compartment 12.
[0092] A first portion 641 of the first longitudinal welded region 64 has a first thickness e6, and a second portion 642 of the first longitudinal welded region 64 has a second thickness e7 that is greater than the first thickness e6.
[0093] Similarly, a first portion 651 of the second longitudinal welded region 65 has a first thickness e9, and a second portion 652 of the second longitudinal welded region 65 has a second thickness e10 that is greater than the first thickness e9.
[0094] 3, the first longitudinal welded region 64 has a connection portion 643 that connects the first portion 641 and the second portion 642 of the first longitudinal welded region 64. The connection portion 643 expands from the first portion 641 toward the second portion 642. The connection portion 643 has a thickness e8 that continuously increases from the first portion 641 toward the second portion 642 of the first longitudinal welded region 64.
[0095] The connecting portion 643 also connects the first portion 641 to a first end of the separate weld region 68. The connecting portion 643 defines the first section 11 and has an edge 648 that forms a first angle θ8 with respect to the transverse axis X.
[0096] The first angle θ8 is in the range of 0° to +70°. Preferably, the first angle θ8 is equal to or smaller than +50°. Preferably, the first angle θ8 is equal to or larger than +20°.
[0097] In the example of Figure 3, the first angle θ8 is not zero. More specifically, in this example, the first angle θ8 is +50°.
[0098] Similarly, the second longitudinal welded region 65 has a connecting portion 653 that connects the first portion 651 and the second portion 652 of the second longitudinal welded region 65. The connecting portion 653 extends from the first portion 651 toward the second portion 652. The connecting portion 653 has a thickness e11 that increases continuously from the first portion 651 toward the second portion 652 of the second longitudinal welded region 65.
[0099] The connecting portion 653 also connects the first portion 651 to a second end of the separate welded region 68 opposite the first end. The connecting portion 653 defines the first section 11 and has an edge 658 that forms a second non-zero angle θ11 with respect to the transverse axis X.
[0100] The second angle θ11 is symmetrical to the first angle θ8 with respect to the longitudinal axis of symmetry.
[0101] Therefore, the second angle θ11 is in the range of −70° to 0°. Preferably, the second angle θ11 is −50° or more. Preferably, the second angle θ11 is −20° or less.
[0102] In the example of Fig. 3, the second angle θ11 is not zero. More specifically, in this example, the second angle θ11 is -50°.
[0103] In the example shown in FIG. 3, each flared connecting portion 643, 653 thus has an edge 648, 658, respectively, on one side of the transverse axis X on which the first section 11 lies, that forms a non-zero angle θ8, θ11 with respect to the transverse axis X.
[0104] The orientation of the edges 648, 658 of the connecting portions 643, 653 of the first and second longitudinal welded regions 64, 65 allows stress to be concentrated in the separate welded regions 68 when pressure P is applied to the first section 11, causing the separate welded regions 68 to rupture in a reproducible and controlled manner.
[0105] This orientation of the edges 648, 658 of the connecting portions 643, 653 of the first and second longitudinal welded regions 64, 65 can also create a Venturi effect that accelerates the flow rate of the first medical substance as it enters the second section 12 when the separate welded region 68 ruptures.
[0106] Each longitudinal weld region 64, 65 has an unwelded reserve region 644, 654 at its flared connecting portion 643, 653, each reserve region 644, 654 being completely surrounded by a weld.
[0107] Each longitudinal welded region 64, 65 also has in its second portion 642, 652 a spare region 645, 655 which is not welded, each spare region 645, 655 being completely surrounded by a weld.
[0108] These spare areas 644 , 654 , 645 , 655 make it possible to prevent wrinkles in the polymer film of the walls when the first wall 2 and the second wall 3 are welded together.
[0109] FIG. 4 shows diagrammatically a bag 1 according to a second embodiment.
[0110] As an example, the bag shown in FIG. 4 may be sized so that the first compartment 11 is suitable for containing approximately 50 milliliters of a first medical substance in liquid form and the second compartment 12 is suitable for containing approximately 7 grams of a second medical substance in powder form.
[0111] As in the first embodiment, the first vertical welded region 64 and the second vertical welded region 65 are obtained by melting the first wall portion 2 and the second wall portion 3 at a first temperature, and the separate welded region 68 is obtained by melting the first wall portion 2 and the second wall portion 3 at a second temperature lower than the first temperature.
[0112] As shown in FIG. 4, in the second embodiment, the separating welded areas 68 extend parallel to the transverse axis X of the bag 1 .
[0113] The separate welded areas 68 are linear.
[0114] Also, the separate weld region 68 has a constant thickness e1 along the transverse axis X.
[0115] The first connecting portion 643 connects the first portion 641 to the second portion 642 of the first longitudinal welded region 64 .
[0116] In the example shown in FIG. 4, the first longitudinal welded region 64 includes a third connecting portion 663 .
[0117] The first connecting portion 643 connects the first portion 641 to the third connecting portion 663. The third connecting portion 663 connects the first connecting portion 643 to the second portion 642 of the first longitudinal welded region 64.
[0118] A first connecting portion 643 of the first longitudinal weld region 64 extends from the first portion 641 towards the separating weld region 68 .
[0119] The third connecting portion 663 narrows from the separating welded region 68 towards the second portion 642 of the first longitudinal welded region 64 .
[0120] In other words, the connecting portion 643 has a thickness e8 that increases continuously from the first portion 641 to the separate welded region 68, and the connecting portion 663 has a thickness e8 that decreases continuously from the separate welded region 68 to the second portion 642 of the first longitudinal welded region 64.
[0121] Similarly, the second longitudinal welded region 65 includes a fourth connecting portion 673 .
[0122] The second connection portion 653 connects the first portion 651 to the fourth connection portion 673. The fourth connection portion 673 connects the second connection portion 653 to the second portion 652 of the second longitudinal welded region 65.
[0123] The second connecting portion 653 of the second longitudinal weld region 65 extends from the first portion 651 of the second longitudinal weld region 65 towards the separating weld region 68 .
[0124] The fourth connecting portion 673 narrows from the separating welded region 68 towards the second portion 652 of the second longitudinal welded region 65 .
[0125] In other words, the connecting portion 653 has a thickness e11 that increases continuously from the first portion 651 to the separate welded region 68, and the connecting portion 673 has a thickness that decreases continuously from the separate welded region 68 to the second portion 642.
[0126] The separate welded region 68 extends from the first longitudinal welded region 64 to the second longitudinal welded region 65 such that a first connection 71 is formed between the separate welded region 68 and the first longitudinal welded region 64 and a second connection 72 is formed between the separate welded region 68 and the second longitudinal welded region 65.
[0127] More specifically, in the example shown in FIG. 4, the separate welded region 68 extends from a connecting portion 643 of the first longitudinal welded region 64 to a connecting portion 653 of the second longitudinal welded region 65 .
[0128] The separate weld region 68 has a dimension 1 measured parallel to the transverse axis X between the first connection portion 71 and the second connection portion 72 .
[0129] The first section 11 has a dimension L measured parallel to the horizontal axis X between the first longitudinal welded area 64 and the second longitudinal welded area 65. The dimension L corresponds to the maximum spacing between the first longitudinal welded area 64 and the second longitudinal welded area 65 measured along an axis parallel to the horizontal axis X and passing through the first section 11.
[0130] The ratio l / L is in the range of 1 / 3 to 3 / 4, preferably in the range of 1 / 3 to 2 / 3.
[0131] More specifically, in the example of FIG. 4, the ratio l / L is 0.57.
[0132] The connecting portion 643 defines a first section 11 and has an edge 648 that forms a first angle θ8 with respect to the transverse axis X.
[0133] The first angle θ8 is in the range of 0° to +70°. Preferably, the first angle θ8 is equal to or smaller than +50°. Preferably, the first angle θ8 is equal to or larger than +20°.
[0134] In the example of Figure 4, the first angle θ8 is not zero. More specifically, in this example, the first angle θ8 is +20°.
[0135] Similarly, the connecting portion 653 connects the first portion 651 to a second end of the separate welded region 68 opposite the first end. The connecting portion 653 defines the first section 11 and has an edge 658 that forms a second non-zero angle θ11 with respect to the transverse axis X.
[0136] The second angle θ11 is symmetrical to the first angle θ8 with respect to the longitudinal axis of symmetry.
[0137] Therefore, the second angle θ11 is in the range of −70° to 0°. Preferably, the second angle θ11 is −50° or more. Preferably, the second angle θ11 is −20° or less.
[0138] In the example of Figure 4, the second angle θ11 is not zero. More specifically, in this example, the first angle θ11 is -20°.
[0139] Thus, each connecting portion 643, 653 has an edge 648, 658, respectively, that forms a non-zero angle θ8, θ11 with respect to the transverse axis X on one side of the transverse axis X on which the first section 11 lies.
[0140] The connecting portion 643 also defines a second section 12 and has another edge 649 that forms a third angle θ4 with respect to the transverse axis X.
[0141] The third angle θ4 is in the range of −70° to 0°. Preferably, the third angle θ4 is −50° or more. Preferably, the third angle θ4 is −20° or less.
[0142] In the example of Figure 4, the third angle θ4 is not zero. More specifically, in this example, the third angle θ4 is -40°.
[0143] Similarly, the connecting portion 653 defines the second section 12 and has another edge 659 that forms a fourth non-zero angle θ5 with respect to the horizontal axis X.
[0144] The fourth angle θ5 is symmetrical to the third angle θ4 with respect to the longitudinal axis of symmetry.
[0145] Therefore, the fourth angle θ4 is in the range of 0° to +70°. Preferably, the fourth angle θ4 is +50° or less. Preferably, the fourth angle θ4 is +20° or more.
[0146] In the example of Fig. 4, the fourth angle θ5 is not zero. More specifically, in this example, the fourth angle θ5 is +40°.
[0147] Thus, each connecting portion 643, 653 has an edge 649, 659, respectively, that forms a non-zero angle θ4, θ5 with respect to the horizontal axis X on the other side of the horizontal axis X on which the second section 11 lies.
[0148] Additionally, each longitudinal weld region 64 , 65 further includes a connecting portion 646 , 656 extending from portion 642 , 652 toward the second transverse weld region 67 .
[0149] The connecting portion 646 of the first longitudinal welded region 64 has an edge that forms a fifth non-zero angle θ9 with respect to a first longitudinal axis Y1 of the bag 1. The first longitudinal axis Y1 extends through the first longitudinal welded region 64 and parallel to the first edge 14. The connecting portion 646 of the first longitudinal welded region 64 extends toward one side of the first longitudinal axis Y1 where the second compartment 12 is located.
[0150] The fifth angle θ9 is in the range of −70° to 0°. Preferably, the fifth angle θ9 is −50° or more. Preferably, the fifth angle θ9 is −20° or less.
[0151] In the example of Figure 4, the fifth angle θ9 is not zero. More specifically, in this example, the fifth angle θ9 is -50°.
[0152] Similarly, the connecting portion 656 of the second longitudinal welded region 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 through the second longitudinal welded region 65 and parallel to the second edge 15. The connecting portion 656 of the second longitudinal welded region 65 extends toward one side of the second longitudinal axis Y2 where the second compartment 12 is located.
[0153] The second angle θ10 is symmetrical to the first angle θ9 with respect to the longitudinal axis of symmetry.
[0154] The sixth angle θ10 is in the range of 0° to +70°. Preferably, the sixth angle θ10 is equal to or smaller than +50°. Preferably, the sixth angle θ10 is equal to or larger than +20°.
[0155] In the example of Figure 4, the sixth angle θ10 is not zero. More specifically, in this example, the sixth angle θ10 is +50°.
[0156] The flared shape of the connecting portions 643, 653, 646, 656 of the longitudinal welded regions 64, 65 induces the flow of the first medical substance into the second compartment 12 such that a swirling flow T (as indicated by the arrows) is generated within the second compartment 12. This swirling flow T effectively mixes the first and second substances within the second compartment 12. In effect, the swirling promotes the circulation of the first medical substance throughout the entire volume of the second compartment 12.
[0157] Furthermore, each of the longitudinal welded regions 64, 65 has an unwelded reserve region 644, 654 at its connecting portion 643, 653, and each reserve region 644, 654 is completely surrounded by the welded portion.
[0158] Furthermore, each longitudinal welded region 64, 65 has an unwelded reserve region 647, 657 at its connecting portion 646, 656, and each reserve region 647, 657 is completely surrounded by the weld.
[0159] As shown in FIG. 5, to prepare a medicinal solution using the bag 1, the first compartment 11 can be manually pressed to increase the pressure within the first compartment 11 until it causes the separating welded area 68 to rupture.
[0160] For this purpose, the bag 1 can be folded along a transverse axis X and pressed in the folded state.
[0161] The rupture of the separating weld area 68 has the effect of placing the first section 11 in communication with the second section 12 .
[0162] The bag 1 may then be unfolded.
[0163] By continuing to apply pressure to the first compartment 11, the pressure applied to the first compartment 11 causes the first medical substance to permeate into the second compartment 12 and mixes with the second medical substance.
[0164] The shape of the connecting portions 643, 653 of the first and second longitudinal welded regions 64, 65 allows stress to be concentrated in the separate welded regions 68 when pressure P is applied to the first section 11 (as shown by the arrows in FIG. 4 at the first section 11) causing the separate welded regions 68 to rupture in a reproducible and controlled manner.
[0165] This shape of the connection portions 643, 653 of the first and second longitudinal welded regions 64, 65 can also create a Venturi effect that accelerates the flow rate of the first medical substance as it enters the second section 12 when the separating welded region 68 ruptures.
[0166] The flared shape of portions 643, 653, 646, 656 also induces the flow of the first medical substance within second compartment 12 to create a swirling flow within second compartment 12 (as shown by the arrows in FIGS. 3 and 4 in second compartment 12). This swirling effectively mixes the first and second substances. In effect, the swirling promotes circulation of the first medical substance throughout the entire volume of second compartment 12.
[0167] Finally, the edges 649, 659 form a funnel shape that facilitates the flow of the medical substance (consisting of a mixture of a first medical substance and a second medical substance) from the second compartment 12 towards the first compartment 11 when administering the medical substance. In other words, the sloping edges 649 and 659 make it possible to avoid that part of the medical substance remains in the second compartment 12 when emptying the bag.
[0168] FIG. 6 shows diagrammatically a bag 1 according to a third embodiment, having three compartments.
[0169] In the third embodiment, the first wall 2 and the second wall 3 are assembled together by being welded at a number of welded areas 6. The welded areas 6 define a first compartment 11, a second compartment 12, and a third compartment 13.
[0170] The first compartment 11 contains a first medical substance, the second compartment 12 contains a second medical substance and the third compartment 13 contains a third medical substance.
[0171] The first medical substance is a liquid substance, the second medical substance is a powder or lyophilisate, and the third substance is a liquid substance.
[0172] As an example, the bag shown in FIG. 6 may be dimensioned such that the first compartment 11 is suitable for containing approximately 80 milliliters of a first medical substance in liquid form, the second compartment 12 is suitable for containing approximately 5 grams of a second medical substance in powder form, and the third compartment 13 is suitable for containing approximately 20 milliliters of a third medical substance in liquid form.
[0173] The second compartment 12 is separated from the first compartment 11 by a first separate weld region 68. That is, the first separate weld region 68 extends between the first compartment 11 and the second compartment 12. The first separate weld region 68 prevents a first medical substance contained in the first compartment 11 from penetrating into the second compartment 12 and prevents a second medical substance contained in the second compartment 12 from penetrating into the first compartment 11.
[0174] The third compartment 13 is separated from the first compartment 11 by a second separate weld area 69. That is, the second separate weld area 69 extends between the first compartment 11 and the third compartment 13. The second separate weld area 69 prevents a first medical substance contained in the first compartment 11 from penetrating into the third compartment 13 and prevents a third medical substance contained in the third compartment 13 from penetrating into the first compartment 11.
[0175] The first separate welded region 68 extends from the first longitudinal welded region 64 to the second longitudinal welded region 65. The first separate welded region 68 extends laterally 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 one side of the transverse axis X and the second compartment 12 is located on the other side of the transverse axis X opposite the one side.
[0176] The first separate welded region 68 extends from the first longitudinal welded region 64 to the second longitudinal welded region 65 such that a first connection 71 is formed between the separate welded region 68 and the first longitudinal welded region 64 and a second connection 72 is formed between the separate welded region 68 and the second longitudinal welded region 65.
[0177] The separate weld region 68 has a dimension 1 measured parallel to the transverse axis X between the first connection portion 71 and the second connection portion 72 .
[0178] The first section 11 also has a dimension L measured between the first longitudinal welded area 64 and the second longitudinal welded area 65 parallel to the horizontal axis X. The dimension L corresponds to the maximum spacing between the first longitudinal welded area 64 and the second longitudinal welded area 65 measured along the horizontal axis X through the first section 11.
[0179] The ratio l / L is in the range of 1 / 3 to 3 / 4, preferably in the range of 1 / 3 to 2 / 3.
[0180] More specifically, in the example of FIG. 6, the ratio l / L is 0.65.
[0181] 6, the first separate welded region 68 consists of a central portion 681 and two side portions 684, 685 located on either side of the central portion 681. Each side portion 684, 685 extends from the central portion 681 to a respective longitudinal welded region 64, 65.
[0182] 6, the central portion 681 of the first separate welded area 68 is straight. The central portion 681 extends parallel to the transverse axis X of the bag 1.
[0183] In the example shown in FIG. 6, a central portion 681 of the separate welded region 68 has a constant thickness e1.
[0184] Additionally, the thickness e1 of the central portion 681 of the separated welded region 68 is less than the thicknesses e4, e5 of each of the side portions 684, 685 of the separated welded region 68.
[0185] Each lateral portion 684, 685 of the first separated weld region 68 extends on either side of the transverse axis X and at a non-zero angle relative to the transverse axis X.
[0186] A first lateral portion 684 of the first separate weld region 68 extends from the central portion 681 toward the first longitudinal weld region 64 .
[0187] Similarly, the second lateral portion 685 of the first separated weld region 68 extends from the central portion 681 towards the second longitudinal weld region 65 .
[0188] In other words, each side portion 684,685 has a thickness e4,e5 that increases continuously from the central portion 681 to each longitudinal weld region 64,65.
[0189] In the example shown in FIG. 6, each side portion 684, 685 has an edge on one side of the horizontal axis X where the first section 11 lies that makes a non-zero angle θ6 with respect to the horizontal axis X, and another edge on the other side of the horizontal axis X where the second section 12 lies that makes a non-zero angle θ7 with respect to the horizontal axis X.
[0190] More specifically, the first lateral portion 684 of the separate weld region 68 extends at a first non-zero angle θ6 on one side of the transverse axis X along which the first section 11 lies.
[0191] A second lateral portion 685 of the separate weld region 68 extends at a second non-zero angle θ7 on one side of the transverse axis X along which the first section 11 lies.
[0192] The first lateral portion 684 of the separate weld region 68 extends at a third non-zero angle θ4 on the other side of the transverse axis X where the second section 12 is located.
[0193] A second lateral portion 685 of the separate weld region 68 extends at a fourth non-zero angle θ5 on the other side of the transverse axis X where the second section 12 is located.
[0194] 6, the first non-zero angle θ6 is symmetrical to the third non-zero angle θ7 about the longitudinal axis of symmetry, and the second non-zero angle θ4 is symmetrical to the fourth non-zero angle θ5 about the longitudinal axis of symmetry.
[0195] Additionally, the first longitudinal welded region 64 and the second longitudinal welded region 65 each include a first portion 641, 651 that defines the first compartment 11 and a second portion 642, 652 that defines the second compartment 12.
[0196] A first portion 641 of the first longitudinal welded region 64 has a first thickness e6, and a second portion 642 of the first longitudinal welded region 64 has a second thickness e7 that is greater than the first thickness e6.
[0197] Similarly, a first portion 651 of the second longitudinal welded region 65 has a first thickness e9, and a second portion 652 of the second longitudinal welded region 65 has a second thickness e10 that is greater than the first thickness e9.
[0198] 6, the first longitudinal welded region 64 has a connection portion 643 that connects the first portion 641 and the second portion 642 of the first longitudinal welded region 64. The connection portion 643 expands from the first portion 641 toward the second portion 642. The connection portion 643 has a thickness e8 that continuously increases from the first portion 641 toward the second portion 642 of the first longitudinal welded region 64.
[0199] The connecting portion 643 also connects the first portion 641 to a first end of the separate weld region 68. The connecting portion 643 defines the first section 11 and has an edge 648 that forms a first angle θ8 with respect to the transverse axis X.
[0200] The first angle θ8 is in the range of 0° to +70°. Preferably, the first angle θ8 is equal to or smaller than +50°. Preferably, the first angle θ8 is equal to or larger than +20°.
[0201] In the example of Figure 6, the first angle θ8 is not zero. More specifically, in this example, the first angle θ8 is +50°.
[0202] Similarly, the second longitudinal welded region 65 has a connecting portion 653 that connects the first portion 651 and the second portion 652 of the second longitudinal welded region 65. The connecting portion 653 extends from the first portion 651 toward the second portion 652. The connecting portion 653 has a thickness e11 that increases continuously from the first portion 651 toward the second portion 652 of the second longitudinal welded region 65.
[0203] The connecting portion 653 also connects the first portion 651 to a second end of the separate welded region 68 opposite the first end. The connecting portion 653 defines the first section 11 and has an edge 658 that forms a second non-zero angle θ11 with respect to the transverse axis X.
[0204] The second angle θ11 is symmetrical to the first angle θ8 with respect to the longitudinal axis of symmetry.
[0205] Therefore, the second angle θ11 is in the range of −70° to 0°. Preferably, the second angle θ11 is −50° or more. Preferably, the second angle θ11 is −20° or less.
[0206] In the example of Fig. 3, the second angle θ11 is not zero. More specifically, in this example, the second angle θ11 is -50°.
[0207] In the example shown in FIG. 6, each flared connecting portion 643, 653 has an edge 648, 658, respectively, on one side of the transverse axis X on which the first section 11 lies, that forms a non-zero angle θ8, θ11 with respect to the transverse axis X.
[0208] Furthermore, each longitudinal welded region 64, 65 has an unwelded reserve region 644, 654 at its flared connecting portion 643, 653, and each reserve region 644, 654 is completely surrounded by a weld.
[0209] Each longitudinal welded region 64, 65 also has in its second portion 642, 652 a spare region 645, 655 which is not welded, each spare region 645, 655 being completely surrounded by a weld.
[0210] These spare areas 644 , 654 , 645 , 655 make it possible to prevent wrinkles in the polymer film of the walls when the first wall 2 and the second wall 3 are welded together.
[0211] A second separate weld region 69 extends from the first lateral weld region 66 to the second longitudinal weld region 65 .
[0212] The second separate welded region 69 has a substantially constant thickness e12 from the first lateral welded region 66 to the second longitudinal welded region 65.
[0213] The second separated welded region 69 includes a first portion 691 extending from the first horizontal welded region 66, a second portion 692 extending to the second vertical welded region 65, and a third portion 693 connecting the first portion 691 and the second portion 692 to each other. The first portion 691 is substantially straight. The second portion 691 is also substantially straight. The third portion 693 is curved. More specifically, the third portion 693 has a curved portion having a convex surface and a concave surface, and the first section 11 is located on the convex side of the curved portion, and the third section 13 is located on the concave side of the curved portion.
[0214] The second separate weld area 69 is also a peelable weld area.
[0215] The bag 1 further comprises a first filling tube 4 and a second filling tube 10 .
[0216] The first filling tube 4 is positioned between the first wall 2 and the second wall 3 through the first lateral welded area 65 so that the first compartment 11 can be filled with a first medical substance via the first filling tube 4.
[0217] The second filling tube 10 is positioned between the first wall 2 and the second wall 3 through the first lateral welded area 65 so that the third compartment 13 can be filled with a third medical substance via the second filling tube 10.
[0218] Once the first compartment 11 has been filled with the first medical substance, the first filling tube 4 can be permanently closed, for example by a stopper or welding.
[0219] Once the third compartment 13 is filled with a third medical substance, the second filling tube 10 can be closed by a connector.
[0220] FIG. 7 shows diagrammatically a bag 1 according to a fourth embodiment.
[0221] As an example, the bag shown in FIG. 7 may be dimensioned such that the first compartment 11 is suitable for containing approximately 40 milliliters of a first medical substance in liquid form, the second compartment 12 is suitable for containing approximately 100 grams of a second medical substance in powder form, and the third compartment 13 is suitable for containing approximately 10 milliliters of a third medical substance in liquid form.
[0222] The infusion bag 1 shown in FIG. 7 has the same features as the bag shown in FIG. 6, except that the volumes of the compartments 11, 12, 13 are different.
[0223] The first separate welded region 68 extends from the first longitudinal welded region 64 to the second longitudinal welded region 65 such that a first connection 71 is formed between the separate welded region 68 and the first longitudinal welded region 64 and a second connection 72 is formed between the separate welded region 68 and the second longitudinal welded region 65.
[0224] The separate weld region 68 has a dimension 1 measured parallel to the transverse axis X between the first connection portion 71 and the second connection portion 72 .
[0225] Additionally, dimension L is measured between first permanently welded area 64 and second permanently welded area 65 along an axis parallel to transverse axis X and passing through first section 11 .
[0226] This dimension L corresponds to the maximum spacing between the first longitudinal welded region 64 and the second longitudinal welded region 65 as measured along a transverse axis X through the first section 11 .
[0227] In the example shown in FIG. 7, an axis parallel to the horizontal axis X passes through both the first section 11 and the third section 13 .
[0228] The ratio l / L is in the range of 1 / 3 to 3 / 4.
[0229] The ratio l / L is in the range of 1 / 3 to 3 / 4, preferably in the range of 1 / 3 to 2 / 3.
[0230] More specifically, in the example of FIG. 7, the ratio l / L is 0.65.
[0231] To prepare a medical solution using the bag 1, the third compartment 13 can be manually pressed to increase the pressure within the third compartment 13 until it causes the separate welded area 69 to rupture.
[0232] The rupture of the second separating weld region 69 has the effect of placing the third section 13 in communication with the first section 11 .
[0233] In other words, when the second separate welded area 69 breaks, the two compartments 11 and 13 form a single compartment 11+13 containing a mixture of the first medical substance and the third medical substance.
[0234] Therefore, in the subsequent preparation process, bag 1 can be used like a two-compartment bag.
[0235] According to a second step, the compartment containing the mixture can be manually pressed to increase the pressure in compartment 11+13 until it causes the rupture of the separating weld zone 68.
[0236] For this purpose, the bag 1 can be folded along a transverse axis X and pressed in the folded state.
[0237] The rupture of the first separating weld area 68 has the effect of placing the section 11+13 in communication with the second section 12.
[0238] The bag 1 may then be unfolded.
[0239] By continuing to apply pressure to compartment 11+13, the pressure applied to compartment 11+13 causes the first medical substance to permeate into second compartment 12 and the mixture of the first medical substance and the second medical substance mixes with the third medical substance. EXAMPLES
[0240] Multiple bags 1 were tested using the parameters listed in Table 1.
[0241] Each bag tested included a first compartment 11 containing approximately 100 milliliters of a first liquid substance and a second compartment containing approximately 5 grams of a powdered second solid substance.
[0242] The first compartment 11 was pressed such that the pressure of the first substance contained in the first compartment 11 increased by about 0.6 bar.
[0243] The presence of a "dead zone" means that there is powder in the second section 12 that is not mixed with the liquid. This means that mixing is insufficient.
[0244] The extent of the rupture of the peelable welded area was observed to determine whether the rupture was suitable to allow sufficient liquid flow from the first compartment 11 to the second compartment 12 .
[0245] We estimated the head loss of the liquid flow entering the second compartment 12. If the head loss is too large, the liquid cannot enter the second compartment at a sufficient flow rate to ensure a good mixing effect between the liquid and the powder.
[0246] [Table 1]
[0247] The stress distribution in the peelable weld area is sufficiently homogeneous if the ratio l / L is less than or equal to 3 / 4. This homogeneous distribution allows for a complete rupture of the peelable weld area.
[0248] Conversely, if the ratio l / L is greater than 3 / 4, the stress acting on the peelable weld area will not be uniformly distributed along the peelable weld area, resulting in incomplete rupture of the peelable weld area, an inability to precisely control the location of the rupture, and high head loss of the liquid flow entering the second section 12.
[0249] On the other hand, if the ratio l / L is less than 1 / 3, it becomes difficult to break the peelable welded area, and in this case, the degree of breakage of the peelable welded area is insufficient to allow a sufficient flow rate of the first medical substance to penetrate into the second compartment and ensure complete and homogeneous mixing with the second medical substance.
[0250] Additionally, the presence of non-zero angles θ8 and θ11 can direct the liquid flow and reduce head loss caused by the liquid flowing through the openings formed in the peelable welded area into the third compartment.
[0251] However, if the value of the angle θ8 is too high (greater than +70°), the effect obtained by having the ratio l / L of 3 / 4 or less is negated.
Claims
1. A bag (1) for containing medical substances for intravenous injection, a first wall portion (2); a second wall portion (3), said first wall (2) and said second wall (3) are assembled together by a welded area (6) which defines at least one first compartment (11) intended to contain a first medical substance and at least one second compartment (12) intended to contain a second medical substance; The welding area (6) is a first permanent weld area (64) extending along a first longitudinal edge (14) of the bag (1); a second permanently welded area (65) extending along a second longitudinal edge (15) of the bag (1) opposite the first longitudinal edge (14); a third peelable weld area (68) separating the first section (11) and the second section (12); the third peelable weld region (68) extends from the first permanent weld region (64) to the second permanent weld region (65) such that a first connection (71) is formed between the third peelable weld region (68) and the first permanent weld region (64) and a second connection (72) is formed between the third peelable weld region (68) and the second permanent weld region (65); The bag (1) has a ratio l / L of a dimension l of the third peelable welded area (68) measured along the horizontal axis (X) between the first connecting portion (71) and the second connecting portion (72) to a dimension L measured along an axis parallel to the horizontal axis (X) and passing through the first compartment (11) between the first permanently welded area (64) and the second permanently welded area (65), the ratio being in the range of 1 / 3 to 3 / 4.
2. The bag (1) according to claim 1, wherein said ratio l / L is in the range of 1 / 3 to 2 / 3.
3. the first permanently welded region (64) comprises a first longitudinal portion (641) extending parallel to the first longitudinal edge (14) of the bag (1) and a first flared portion (643) extending from the first longitudinal portion (641) to the first connecting portion (71), the first flared portion (643) defining the first compartment (11) at a first angle (θ8) in the range of 0° to +70° with respect to a horizontal axis (X) extending perpendicular to the longitudinal edges (14, 15); 3. The bag (1) according to claim 1 or 2, wherein the second permanently welded region (65) includes a second longitudinal portion (651) extending parallel to the second longitudinal edge (15) of the bag (1) and a second flared portion (653) extending from the second longitudinal portion (651) to the second connecting portion (72), and the second flared portion (653) defines the first compartment (11) at a second angle (θ11) in the range of −70° to 0° with respect to the horizontal axis.
4. The bag according to claim 3, wherein the first angle (θ8) is in the range of 0° to +50° relative to the horizontal axis (X), and the second angle (θ11) is in the range of −50° to 0° relative to the horizontal axis (X).
5. The bag according to claim 3, wherein the first angle (θ8) is in the range of +20° to +50° relative to the horizontal axis, and the second angle (θ11) is in the range of −50° to −20° relative to the horizontal axis (X).
6. the first permanently welded region (64) includes a third longitudinal portion (642) extending parallel to the first longitudinal edge (14) of the bag (1) and a third flared portion (663) extending from the third longitudinal portion (642) to the first connecting portion (71), the third flared portion (663) defining the second compartment (12) at a third angle (θ4) in the range of -70° to 0° with respect to a horizontal axis (X) extending perpendicular to the longitudinal edges (14, 15); 3. The bag according to claim 1, wherein the second permanently welded region (65) includes a fourth longitudinal portion (652) extending parallel to the second longitudinal edge (15) of the bag (1) and a fourth flared portion (673) extending from the fourth longitudinal portion (652) to the second connecting portion (72), and the fourth flared portion (673) forms a fourth angle (θ5) in the range of 0° to +70° with respect to the horizontal axis (X) to define the second compartment (11).
7. 7. The bag of claim 6, wherein the third angle (θ4) is in the range of −50° to 0° relative to the horizontal axis (X), and the fourth angle (θ5) is in the range of 0° to +50° relative to the horizontal axis.
8. The bag of claim 6, wherein the third angle (θ4) is in the range of −50° to −20° relative to the horizontal axis, and the fourth angle (θ5) is in the range of +20° to +50° relative to the horizontal axis.
9. the first permanently welded region (64) and the second permanently welded region (65) are obtained by melting the first wall portion (2) and the second wall portion (3) at a first temperature; the third peelable weld area (68) is obtained by fusing the first wall (2) and the second wall (3) at a second temperature lower than the first temperature; 3. The bag of claim 1, wherein when the first medical substance is placed in the first compartment (11) and pressure is applied to the first compartment (11), the pressure acting on the first compartment (11) causes the third peelable weld area (68) to rupture, allowing the first medical substance to enter the second compartment (12).
10. 3. A bag according to claim 1 or 2, wherein the first compartment (11) contains the first medical substance.
11. 11. The bag of claim 10, wherein the first medical substance is a liquid substance.
12. 3. A bag according to claim 1 or 2, wherein the second compartment (12) contains the second medical substance.
13. 13. The bag of claim 12, wherein the second medical substance is a powder or a lyophilisate.
14. 3. A method for preparing a medicinal solution using a bag (1) according to claim 1 or 2, wherein the first compartment (11) of the bag (1) contains a first medical substance and the second compartment (12) of the bag (1) contains a second medical substance, said method comprising: The method includes a step of pressing the first compartment (11) to cause the third peelable weld area (68) to rupture, thereby allowing the first medical substance to enter the second compartment (12).
15. A method for manufacturing a bag (1), comprising the steps of: The method includes the step of welding the first wall (2) and the second wall (3) together at a welding area (6), said welded area (6) defines at least one first compartment (11) intended to contain a first medical substance and at least one second compartment (12) intended to contain a second medical substance; The welding area (6) is a first permanent weld area (64) extending along a first longitudinal edge (14) of the bag (1); a second permanently welded area (65) extending along a second longitudinal edge (15) of the bag (1) opposite the first longitudinal edge (14); a third peelable weld area (68) separating the first section (11) and the second section (12); the third peelable weld region (68) extends from the first permanent weld region (64) to the second permanent weld region (65) such that a first connection (71) is formed between the third peelable weld region (68) and the first permanent weld region (64) and a second connection (72) is formed between the third peelable weld region (68) and the second permanent weld region (65); The method of claim 1, wherein a ratio l / L of a dimension l of the third peelable weld area (68) measured between the first connection portion (71) and the second connection portion (72) to a dimension L of the first section (11) measured between the first permanent weld area (64) and the second permanent weld area (65) is in the range of 1 / 3 to 3 / 4.
16. The step of welding the first wall portion (2) and the second wall portion (3) includes: a step of melting the first wall portion (2) and the second wall portion (3) at a first temperature, thereby welding the first wall portion (2) and the second wall portion (3) together at the first permanent welding area (64) and the second permanent welding area (65); and fusing the first wall portion (2) and the second wall portion (3) at the third peelable weld area (68) by melting the first wall portion (2) and the second wall portion (3) at a second temperature lower than the first temperature.