Pouch intended to contain medical substances for intravenous injection
Patent Information
- Application Number
- FR2022002581
- Authority / Receiving Office
- FR · FR
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2022-03-23
- Publication Date
- 2025-03-21
- Estimated Expiration
- 2042-03-23
Smart Images

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Abstract
Description
Title of the invention: Bag intended to contain medical substances for intravenous injection Technical field
[0001] The 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
[0002] Bags intended to contain medicinal solutions for intravenous injection (such as a drug, a solute, a physiological solution or a blood-derived product for example) are flexible bags which can be connected to tubing allowing parenteral administration of the medicinal solution to a patient or allowing withdrawal by means of a syringe of the medicinal solution from the bag for administration to the patient.
[0003] These pockets are generally manufactured by welding two flexible films made of polymer materials together.
[0004] These bags can be sterilized by irradiation before aseptic filling and / or by autoclaving after filling.
[0005] Document FR 3 058 638 A1 describes a medical pouch formed from 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 pouch comprises a permanent seal around the perimeter of the pouch and a peelable seal between the two compartments. The peelable seal is intended to be broken at the time of use of the pouch, so as to put the first compartment and the second compartment in communication in order to mix the first compound and the second compound together just before administration to the patient.
[0006] Such bags make it possible to package very unstable medical substances, which cannot be preserved by being mixed, and which need to be mixed together in order to reconstitute the drug solution just before administration to the patient.
[0007] A problem with these pockets is that the breakage of the peelable seal is not always well controlled.
[0008] However, depending on where the break in the peelable seal occurs and the extent of the break, there is a risk that the first compound will not mix in the entire volume of the second compartment. In this case, the mixture between the two compounds is not complete, which does not allow the prescribed dosage to be respected with certainty.
[0009] Furthermore, when administering the medical substance, there is a risk that the two films adhere together, thus creating retention areas, which prevent the bag from emptying completely. In this case, the patient does not receive all of the medical substance. SUMMARY
[0010] One objective is to provide a bag intended to contain medical substances for intravenous injection which allows better control of the mixing between two medical substances.
[0011] This objective is achieved by means of a bag intended to contain medical substances for intravenous injection, comprising: - a first wall, and - a second wall, the first wall and the second wall being assembled together by welding zones, the welding zones delimiting at least a first compartment intended to contain a first medical substance and at least a second compartment intended to contain a second medical substance, in which the welding zones include: - a first permanent welding zone extending along a first longitudinal edge of the pocket, - a second permanent weld zone extending along a second longitudinal edge of the pocket, opposite the first longitudinal edge, and - a third peelable weld zone separating the first compartment from the second compartment, 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 junction between the third peelable weld zone and the first permanent weld zone, and a second junction between the third peelable weld zone and the second permanent weld zone, and wherein a ratio 1 / L between a dimension 1 of the third peelable weld zone measured between the first junction and the second junction along a transverse axis, and a dimension L measured between the first permanent weld and the second permanent weld along an axis parallel to the transverse axis and passing through the first compartment, is within a range of 1 / 3 to 3 / 4.
[0012] The specific dimension ratio between the third peelable weld zone and the spacing between the two permanent weld zones allows the location where the rupture occurs as well as the extent of the rupture to be controlled, and this in a manner repeatable.
[0013] Indeed, it has been found that a 1 / L ratio of less than 1 / 3 results in the third peelable seal zone being difficult to break. In this case, the extent of the breakage of the third peelable seal zone may be insufficient, which does not allow for the generation of a sufficient flow rate of the first medical substance entering the second compartment to ensure complete and homogeneous mixing with the second medical substance.
[0014] A 1 / L ratio greater than 3 / 4 results in the stress exerted on the third peelable seal zone not being distributed homogeneously along the third peelable seal zone. In this case, it is not possible to precisely control the location where the rupture of the third peelable seal zone occurs, which does not allow the flow of the first medical substance entering the second compartment to be favorably located to ensure complete and homogeneous mixing with the second medical substance.
[0015] On the other hand, with a 1 / L ratio in the range of 1 / 3 to 3 / 4, as proposed, it is possible to control both the direction and the intensity of the flow of the first medical substance entering the second compartment, without having to exert excessive pressure on the first compartment. This makes it possible to obtain a complete and homogeneous mixing of the two substances, and this in a repeatable manner.
[0016] The bag may further have the following characteristics:
[0017] - the 1 / L ratio is within a range from 1 / 3 to 2 / 3.
[0018] - the first permanent welding zone comprises a first longitudinal portion longitudinal extending parallel to the first longitudinal edge of the pocket and a first flared portion extending from the first longitudinal portion to the first junction, the first flared portion delimiting the first compartment by forming a first angle in a range from 0° to + 70° with a transverse axis extending perpendicular to the longitudinal edges, and the second permanent weld zone comprises a second longitudinal portion extending parallel to the second longitudinal edge of the pocket and a second flared portion extending from the second longitudinal portion to the second junction, the second flared portion delimiting the first compartment by forming a second angle in a range from - 70° to 0 with the transverse axis.
[0019] - the first angle is within a range from 0° to + 50° relative to the transverse axis, and the second angle is in the range from - 50° to 0° with the transverse axis.
[0020] - the first angle is within a range from + 20° to + 50° relative to the transverse axis, and the second angle is in the range from -50° to -20° with the transverse axis.
[0021] - the first permanent welding zone comprises a third longitudinal portion longitudinal extending parallel to the first longitudinal edge of the pocket and a third flared portion extending from the third longitudinal portion to the first junction, the third flared portion delimiting the second compartment by forming a third angle in a range from - 70° to 0 with a transverse axis extending perpendicular to the longitudinal edges, and the second permanent weld zone comprises a fourth longitudinal portion extending parallel to the second longitudinal edge of the pocket and a fourth flared portion extending from the fourth longitudinal portion to the second junction, the fourth flared portion delimiting the second compartment by forming a fourth angle in a range from 0° to + 70° with the transverse axis.
[0022] - the third angle is within a range from - 50° to 0 relative to the transverse axis, and the fourth angle is in the range from 0° to +50° with the transverse axis.
[0023] - the third angle is within a range from - 50° to - 20° relative to the transverse axis, and the fourth angle is within a range of +20° to +50° with the transverse axis.
[0024] - the first permanent welding zone and the second welding zone permanent were obtained by melting the first wall and the second wall at a first temperature, and the third peelable seal zone was obtained by melting the first wall and the second wall at a second temperature, lower than the first temperature, so that when the first medical substance is received in the first compartment and pressure is exerted on the first compartment, the pressure exerted on the first compartment causes the third peelable seal zone to rupture, thereby allowing penetration of the first medical substance into the second compartment.
[0025] - the pouch comprises the first medical substance contained in the first com department.
[0026] - the first medical substance is a liquid substance.
[0027] - the pouch comprises the second medical substance contained in the second compartment.
[0028] - the second medical substance is a powder or a lyophilisate.
[0029] A medicinal solution may be prepared by a method of preparing a medicinal solution from a pouch as defined above, wherein the first compartment of the pouch contains a first medical substance and the second compartment of the pouch contains a second medical substance, the method comprising a step of pressing the first compartment of so as to cause a rupture of the third peelable seal zone, thus allowing penetration of the first medical substance into the second compartment.
[0030] A pocket as defined above can be manufactured according to a manufacturing method, comprising steps of: - welding together a first wall and a second wall in welding zones, the welding zones delimiting at least a first compartment intended to receive a first medical substance and at least a second compartment intended to receive a second medical substance, and
[0031] wherein the weld zones include: - a first permanent welding zone extending along a first longitudinal edge of the pocket, - a second permanent weld zone extending along a second longitudinal edge of the pocket, opposite the first longitudinal edge, and - a third peelable weld zone separating the first compartment from the second compartment, 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 junction between the third peelable weld zone and the first permanent weld zone and a second junction between the third peelable weld zone and the second permanent weld zone, and wherein a ratio 1 / L between a dimension 1 of the third peelable weld zone measured between the first junction and the second junction, and a dimension L of the first compartment measured between the first permanent weld and the second permanent weld, is within a range of 1 / 3 to 3 / 4.
[0032] The steps of welding the first wall and the second wall together may comprise: - welding the first wall and the second wall in the first permanent weld zone and in the second permanent weld zone, by melting the first wall and the second wall at a first temperature, and - welding the first wall and the second wall together in the third peelable welding zone, by melting the first wall and the second wall at a second temperature, lower than the first temperature. PRESENTATION OF THE DRAWINGS
[0033] Other characteristics and advantages will emerge from the following description, which is purely illustrative and non-limiting, and must be read in conjunction with the appended figures, among which:
[0034] - [Fig.l] schematically represents a pocket intended to contain medical substances for intravenous injection, front view,
[0035] - [Fig.2] represents the pocket of [Fig.l], seen from behind,
[0036] - [Fig.3] schematically represents a pocket intended to contain medical substances for intravenous injection in accordance with a first possible embodiment, before filling,
[0037] - [Fig.4] schematically represents a pocket intended to contain medical substances for intravenous injection according to a second possible embodiment, before filling,
[0038] - [Fig.5] schematically represents a step in the preparation of a medicinal solution from a bag,
[0039] - [Fig.6] schematically represents a pocket intended to contain medical substances for intravenous injection according to a third possible embodiment, before filling,
[0040] - [Fig.7] schematically represents a pocket intended to contain medical substances for intravenous injection according to a fourth possible embodiment, before filling. DETAILED DESCRIPTION OF AN EMBODIMENT
[0041] In Figures 1 and 2, the bag 1 shown comprises a first wall 2, a second wall 3, a filling tube 4 and a connector 5.
[0042] The first wall 2 and the second wall 3 are assembled together by thermal welding in a plurality of welding zones 6. The welding zones 6 delimit, between the first wall 2 and the second wall 3, a first compartment 11 and a second compartment 12, separate from the first compartment 11.
[0043] The first compartment 11 contains a first medical substance and the second compartment 12 contains a second medical substance.
[0044] In the example illustrated in [Fig.l], 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 contains 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 together in order to prepare a medicinal solution, just before administering the medicinal solution to a patient.
[0045] The first wall 2 may be formed from a first film of polymer material, for example a polymer material comprising a polyolefin, such as polypropylene or polyethylene.
[0046] Similarly, the second wall 3 may be formed from a second film identical to the first film. The second wall may be formed from a second film made of material polymer, for example a polymer material comprising a polyolefin, such as polypropylene or polyethylene.
[0047] The filling tube 4 is arranged between the first wall 2 and the second wall 3, so as to allow filling of the first compartment 11 with the first medical substance via the filling tube 4. More specifically, the filling tube 4 has a first end having a first opening opening into the first compartment 11 and a second end, opposite the first end, having a second opening opening outside the first compartment 11. More specifically, the second opening opens outside the bag 1. The filling tube 4 further comprises an internal channel extending from the first opening to the second opening.
[0048] The connector 5 seals the second opening of the filling tube 4. The connector 5 comprises a breakable portion 51 which can be broken. Once broken, the breakable portion 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 device or to a syringe.
[0049] Furthermore, as illustrated in [Fig.l], the pocket 1 may further comprise a first protective sheet 7 fixed to the first wall 2 and / or a second protective sheet 8 fixed to the second wall 3.
[0050] The first protective sheet 7 covers an external surface of the first wall 2 so as to mask the second compartment 12, but without masking the first compartment 11. Similarly, the second protective sheet 8 covers an external surface of the second wall 3, so as to mask the second compartment 11, but without masking the first compartment 11.
[0051] The first protective sheet 7 and the second protective sheet 8 each form a barrier which prevents penetration of moisture, light radiation and / or oxygen respectively through the first wall 2 and through the second wall 3, towards the interior of the second compartment 12 which contains the second medical substance.
[0052] For this purpose, the first protective sheet 7 and the second protective sheet 8 may each comprise a layer of aluminum, or a layer of a compound containing aluminum.
[0053] The first protective sheet 7 and / or the second protective sheet 8 may be fixed respectively to the first wall 2 and / or to the second wall 3 by a peelable weld, allowing the first protective sheet 7 and / or the second protective sheet 8 to be removed before using the bag. The removal of the first protective sheet 7 and / or the second protective sheet 8 may allow the condition of the second medical substance contained in the second compartment 12 to be visually checked, before mixing the first medical substance with the second medical substance.
[0054] Alternatively, the first protective sheet 7 and / or the second protective sheet 8 may be fixed respectively to the first wall 2 and / or to the second wall 3 by a permanent weld. 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 may be transparent to light radiation in the visible range, in order to allow visual monitoring of the state of the second medical substance contained in the second compartment 12.
[0055] The pocket 1 may further have an orifice 9 provided through both the first wall 2 and the second wall 3 in a welding zone, the orifice 9 making it possible to suspend the pocket 1 from a hook during its use.
[0056] When the bag 1 is suspended from a hook, the second compartment 12 is arranged above the first compartment 11, and the filling tube 4 extends vertically downwards.
[0057] [Fig. 3] schematically represents a pocket 1 according to a first embodiment.
[0058] By way of example, the pouch 1 illustrated in [Fig. 3] may be sized such that the first compartment 11 is adapted to contain approximately 250 milliliters of the first medical substance in liquid form, while the second compartment 12 is adapted to contain from a few milligrams up to several hundred grams of the second medical substance in powder form, for example 100 grams.
[0059] The pocket 1 illustrated in [Fig.3] 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.
[0060] The pocket 1 further comprises a plurality of welding zones 6 delimiting the first compartment 11 and the second compartment 12.
[0061] More specifically, the weld zones 6 include 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.
[0062] In addition, the weld zones 6 also include a first transverse weld zone 66 extending along the first transverse edge 16.
[0063] In [Fig. 3], the bag 1 is shown before filling. That is to say that the first compartment 11 does not yet contain the first medical substance and the second compartment 12 does not yet contain the second medical substance. Therefore, the welding zones 6 do not yet include a second transverse welding zone extending along the second transverse edge 17. Thus, the second medical substance can be introduced into the second compartment 12 via the opening which remains between the first wall 2 and the second wall 3 which are not welded together along the second transverse edge 17.
[0064] 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 can be made (the second transverse weld zone 67 is illustrated in dotted lines in [Fig. 3]).
[0065] In addition, an orifice 9 may be provided in the second transverse welding zone 67, through both the first wall 2 and the second wall 3, to allow the pocket 1 to be suspended from a hook.
[0066] 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 to say that these weld zones have been obtained by subjecting the first wall 2 and the second wall 3 to a first temperature which has caused a fusion of the first film and the second film between them, so as to obtain a permanent bond of the walls 2 and 3 between them 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 for example be between 90 and 160 degrees Celsius. In the case of polypropylene films, the first temperature can be of the order of 140 to 150 degrees Celsius approximately for 3 seconds.
[0067] Furthermore, the welding zones 6 also include a separating welding zone 68 which separates the first compartment 11 from the second compartment 12. That is to say, the separating welding zone 68 extends between the first compartment 11 and the second compartment 12, prevents penetration of the first substance contained in the first compartment 11 towards the second compartment 12, and prevents penetration of the second substance contained in the second compartment 12 towards the first compartment 11.
[0068] Thus, the first compartment 11 is delimited by the first longitudinal welding zone 64, the second longitudinal welding zone 65, the first transverse welding zone 66 and the separating welding zone 68.
[0069] The second compartment 12 is delimited by the first longitudinal welding zone 64, the second longitudinal welding zone 65, the separating welding zone 68 and the second transverse welding zone 67.
[0070] The separating weld zone 68 is a peelable weld zone. That is to say that this zone was produced by subjecting the first wall 2 and the second wall 3 to a second temperature which caused the first film and the second film to melt, the second temperature being lower than the first temperature.
[0071] In this way, the first wall 2 and the second wall 3 are assembled together in the separating weld zone 68, but the assembly obtained is not permanent. Thus, when using the pocket 1, the weld can be broken in this zone, for example under the effect of pressure exerted on the first compartment 11.
[0072] The choice of the second temperature depends on the composition of the first film and the second film. The second temperature can for example be between 65 and 145 degrees Celsius.
[0073] As illustrated in [Fig.3], the separating weld zone 68 extends from the first longitudinal weld zone 64 to the second longitudinal weld zone 65.
[0074] In addition, the separating weld zone 68 extends in a transverse direction, along a transverse axis X of the pocket 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 the first side.
[0075] 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 junction 71 between the separating weld zone 68 and the first longitudinal weld zone 64, and a second junction 72 between the separating weld zone 68 and the second longitudinal weld zone 65.
[0076] In other words, the first junction 71 is where the separating weld zone 68 meets the first longitudinal weld zone 64, and the second junction 72 is where the separating weld zone 68 meets the second longitudinal weld 65.
[0077] The separating weld zone 68 has a dimension 1 measured between the first junction 71 and the second junction 72, parallel to the transverse axis X.
[0078] Furthermore, the first compartment 11 has a dimension L measured between the first longitudinal weld 64 and the second longitudinal weld 65, parallel to the transverse axis X.
[0079] 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, parallel to the transverse axis X.
[0080] The ratio 1 / L between is in a range from 1 / 3 to 3 / 4, preferably in a range from 1 / 3 to 2 / 3.
[0081] More precisely, in the example illustrated in [Fig. 3], the ratio 1 / L is equal to 0.65.
[0082] In the example illustrated in [Fig. 3], the separating 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 either side 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.
[0083] In the example illustrated in [Fig.3], the central portion 681 is rectilinear and extends parallel to the transverse axis X of the pocket 1. In other words, the central portion 681 has two edges parallel to the transverse axis X.
[0084] The central portion 681 of the separating weld zone 68 has a thickness e1 less than a thickness e4, e5 of each of the lateral portions 684, 685 of the separating weld zone 68.
[0085] More precisely, in the example illustrated in [Fig.3], the central portion 681 of the separating weld zone 68 has a constant thickness el.
[0086] The first lateral portion 684 of the separating weld zone 68 flares from the central portion 681 towards the first longitudinal weld zone 64.
[0087] Similarly, the second lateral portion 685 of the separating weld zone 68 widens from the central portion 681 towards the second longitudinal weld zone 65.
[0088] In other words, each lateral portion 684, 685 has a thickness e4, e5 which increases continuously from the central portion 681 to a respective longitudinal welding zone 64, 65.
[0089] More precisely, in the example illustrated in [Fig.3], each lateral portion 684, 685 has an edge which delimits the second compartment 12 and which forms a non-zero angle relative to the transverse axis X, on the second side of the transverse axis X where the second compartment 12 is located.
[0090] The first lateral portion 684 flares out, forming a first non-zero angle 04 relative to the transverse axis X.
[0091] The first angle θ4 is in a range 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°.
[0092] In the example illustrated in [Fig.3], the first angle 04 is non-zero. More precisely, in this example, the first angle 04 is equal to - 45°.
[0093] Similarly, the second lateral portion 685 flares out, forming a second non-zero angle 05 relative to the transverse axis X. The second angle 05 is symmetrical to the first angle 04, relative to a longitudinal axis of symmetry.
[0094] Thus, the second angle 05 is within a range from 0 to +70°. Preferably, the second angle 05 is less than or equal to +50°. Preferably, the second angle 05 is greater than or equal to +20°.
[0095] In the example illustrated in [Fig.3], the first angle 05 is non-zero. More precisely, in this example, the first angle 05 is equal to + 45°.
[0096] Due to its thickness el being less than the thicknesses e4 and e5, the central portion 681 of the separating weld zone 68 constitutes a portion of lesser resistance of the separating weld zone 68.
[0097] Furthermore, the flared shape of the lateral portions 684, 685 of the separating weld zone 68 makes it possible to avoid the presence in the second compartment 12 of recesses in which the second medical substance could accumulate, which would risk degrading the quality of the mixture or not allowing complete emptying of the bag.
[0098] Furthermore, the first longitudinal welding zone 64 and the second longitudinal welding zone 65 each comprise a respective first portion 641, 651 delimiting the first compartment 11 and a respective second position 642, 652 delimiting the second compartment 12.
[0099] 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, greater than the first thickness e6.
[0100] Similarly, the first portion 651 of the second longitudinal welding zone 65 has a first thickness e9 and the second portion 652 of the second longitudinal welding zone 65 has a second thickness el0, greater than the first thickness e9.
[0101] Furthermore, as illustrated in [Fig. 3], the first longitudinal weld zone 64 has a joining portion 643 connecting the first portion 641 to the second portion 642 of the first longitudinal weld zone 64. The joining portion 643 widens from the first portion 641 to the second portion 642. The joining portion 643 has a thickness e8 which increases continuously from the first portion 641 to the second portion 642 of the first longitudinal weld zone 64.
[0102] In addition, 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 08 relative to the transverse axis X.
[0103] The first angle 08 is in a range from 0 to +70°. Preferably, the first angle 08 is less than or equal to +50°. Preferably, the first angle 08 is greater than or equal to +20°.
[0104] In the example illustrated in [Fig.3], the first angle 08 is non-zero. More precisely, in this example, the first angle 08 is equal to + 50°.
[0105] Similarly, the second longitudinal weld zone 65 has a joining portion 653 connecting the first portion 651 to the second portion 652 of the second longitudinal weld zone 65. The joining portion 653 widens from the first portion 651 to the second portion 652. The joining portion 653 has a thickness el 1 which increases continuously from the first portion 651 to the second portion 652 of the second longitudinal weld zone 65.
[0106] In addition, the joining portion 653 connects the first portion 651 to a second end of the separating weld zone 68, opposite the first end. The joining portion 653 has an edge 658 which delimits the first compartment 11 and which forms a second non-zero angle 011 with respect to the transverse axis X.
[0107] The second angle 011 is symmetrical to the first angle 08, with respect to a longitudinal axis of symmetry.
[0108] Thus, the second angle 011 is within a range from -70° to 0. Preferably, the second angle 011 is greater than or equal to -50°. Preferably, the second angle 011 is less than or equal to -20°.
[0109] In the example illustrated in [Fig.3], the second angle 011 is non-zero. More precisely, in this example, the second angle 011 is equal to - 50°.
[0110] In the example illustrated in [Fig.3], each flared junction portion 643, 653 thus has an edge 648, 658 respectively forming a non-zero angle 08, 011 relative to the transverse axis X, on the first side of the transverse axis X where the first compartment 11 is located.
[0111] The orientation of the edges 648 and 658 of the junction portions 643 and 653 of the first and second longitudinal welds 64 and 65 makes it possible on the one hand to concentrate the stresses on the separating weld zone 68 when a pressure P is exerted on the first compartment 11, so as to promote a repeatable and controlled rupture of the separating weld zone 68.
[0112] On the other hand, 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 also makes it possible to create a Venturi effect, once the separating weld zone 68 has been broken, which accelerates the speed of the flow of the first medical substance when the first medical substance enters the second compartment 12.
[0113] Each longitudinal weld zone 64, 65 has, in its flared joining portion 643, 653, a non-welded relief zone 644, 654, each relief zone 644, 654 being completely surrounded by the weld.
[0114] Each longitudinal welding zone 64, 65 further has, in its second portion 642, 652, a non-welded relief area 645, 655, each relief area 645, 655 being completely surrounded by the weld.
[0115] These saving zones 644, 654, 645, 655 make it possible to avoid generating folds in the polymer films of the walls when welding the first wall 2 and the second wall 3 together.
[0116] [Fig.4] schematically represents a pocket 1 according to a second embodiment.
[0117] By way of example, the pouch illustrated in [Fig.4] may be sized such that the first compartment 11 is adapted to contain approximately 50 milliliters of the first medical substance in liquid form, while the second compartment 12 is adapted to contain approximately 7 g of the second medical substance in powder form.
[0118] As in the first embodiment, the first longitudinal weld zone 64 and the second longitudinal weld zone 65 were obtained by melting the first wall 2 and the second wall 3 at a first temperature, while the separating weld zone 68 was obtained by melting the first wall 2 and the second wall 3 at a second temperature, lower than the first temperature.
[0119] As illustrated in [Fig.4], in this second embodiment, the separating weld zone 68 extends parallel to the transverse axis X of the pocket 1.
[0120] The separating weld zone 68 has a rectilinear shape.
[0121] In addition, the separating weld zone 68 has a constant thickness el, along the transverse axis X.
[0122] The first joining portion 643 connects the first portion 641 to the second portion 642 of the first longitudinal welding zone 64.
[0123] In the example illustrated in [Fig.4], the first longitudinal weld 64 comprises a third joining portion 663
[0124] 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 to the second portion 642 of the first longitudinal weld zone 64.
[0125] The first joining portion 643 of the first longitudinal weld 64 flares from the first portion 641 to the separating weld zone 68.
[0126] The third joining portion 663 thins from the separating weld zone 68 to the second portion 642 of the first longitudinal weld zone 64.
[0127] In other words, the joining portion 643 has a thickness e8 which increases continuously from the first portion 641 to the separating weld zone 68 and the joining portion 663 has a thickness e8 which decreases continuously from the separating weld zone 68 to the second portion 642 of the first longitudinal weld zone 64.
[0128] Similarly, the second longitudinal weld 65 comprises a fourth joining portion 673
[0129] 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 to the second portion 652 of the second longitudinal weld zone 65.
[0130] The second joining portion 653 of the second longitudinal weld 65 flares from the first portion 651 to the separating weld zone 68 of the second longitudinal weld zone 65.
[0131] The fourth joining portion 673 thins from the separating weld zone 68 to the second portion 652 of the second longitudinal weld zone 65.
[0132] In other words, the joining portion 653 has a thickness el 1 which increases continuously from the first portion 651 to the separating weld zone 68 and the joining portion 673 has a thickness which decreases continuously from the separating weld zone 68 to the second portion 652.
[0133] 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 junction 71 between the separating weld zone 68 and the first longitudinal weld zone 64, and a second junction 72 between the separating weld zone 68 and the second longitudinal weld zone 65.
[0134] More precisely, in the example illustrated in [Fig.4], 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.
[0135] The separating weld zone 68 has a dimension 1 measured between the first junction 71 and the second junction 72, parallel to the transverse axis X.
[0136] The first compartment 11 has a dimension L measured between the first longitudinal weld 64 and the second longitudinal weld 65, parallel to the transverse axis X. 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, parallel to the transverse axis X.
[0137] The ratio 1 / L between is in a range from 1 / 3 to 3 / 4, preferably in a range from 1 / 3 to 2 / 3.
[0138] More precisely, in the example illustrated in [Fig.4], the ratio 1 / L is equal to 0.57.
[0139] The junction portion 643 has an edge 648 which delimits the first compartment 11 and which forms a first angle 08 with respect to the transverse axis X.
[0140] The first angle 08 is in a range from 0 to +70°. Preferably, the first angle 08 is less than or equal to + 50°. Preferably, the first angle 08 is greater than or equal to + 20°.
[0141] In the example illustrated in [Fig.4], the first angle 08 is non-zero. More precisely, in this example, the first angle 08 is equal to + 20°.
[0142] Similarly, the joining portion 653 connects the first portion 651 to a second end of the separating weld zone 68, opposite the first end. The joining portion 653 has an edge 658 which delimits the first compartment 11 and which forms a second non-zero angle 011 with respect to the transverse axis X.
[0143] The second angle 011 is symmetrical to the first angle 08, with respect to a longitudinal axis of symmetry.
[0144] Thus, the second angle 011 is within a range from -70° to 0. Preferably, the second angle 011 is greater than or equal to -50°. Preferably, the second angle 011 is less than or equal to -20°.
[0145] In the example illustrated in [Fig.4], the second angle 011 is non-zero. More precisely, in this example, the first angle 011 is equal to - 20°.
[0146] Thus, each junction portion 643, 653 has an edge 648, 658 respectively forming a non-zero angle 08, 011 relative to the transverse axis X, on the first side of the transverse axis X where the first compartment 11 is located.
[0147] Furthermore, the joining portion 643 has another edge 649 which delimits the second compartment 12 and which forms a third angle 04 relative to the transverse axis X.
[0148] The third angle θ4 is in a range 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°.
[0149] In the example illustrated in [Fig.4], the third angle 04 is non-zero. More precisely, in this example, the third angle 04 is equal to - 40°.
[0150] Similarly, the joining portion 653 has another edge 659 which delimits the second compartment 12 and which forms a fourth non-zero angle 05 with respect to the transverse axis X.
[0151] The fourth angle 05 is symmetrical to the third angle 04, with respect to a longitudinal axis of symmetry.
[0152] Thus, the fourth angle 04 is within a range from 0 to +70°. Preferably, the fourth angle 04 is less than or equal to +50°. Preferably, the fourth angle 05 is greater than or equal to +20°.
[0153] In the example illustrated in [Fig.4], the fourth angle 05 is non-zero. More precisely, in this example, the fourth angle 05 is equal to + 40°.
[0154] Each junction portion 643, 653 thus has an edge 649, 659 respectively forming a non-zero angle 04, 05 relative to the transverse axis X, on the second side of the transverse axis X where the second compartment 11 is located.
[0155] Furthermore, each longitudinal weld zone 64, 65 also comprises a joining portion 646, 656 which flares from the portion 642, 652 to the second transverse weld 67.
[0156] The joining portion 646 of the first longitudinal welding zone 64 has an edge which forms a fifth non-zero angle 09 with respect to a first longitudinal axis Y1 of the pocket 1. The first longitudinal axis Y1 extends parallel to the first edge 14 passing through the first longitudinal welding zone 64. The joining portion 646 of the first longitudinal welding zone 64 widens towards one side of the first longitudinal axis Y1 where the second compartment 12 is located.
[0157] The fifth angle 09 is in a range from -70° to 0. Preferably, the fifth angle 09 is greater than or equal to -50°. Preferably, the fifth angle 09 is less than or equal to -20°.
[0158] In the example illustrated in [Fig.4], the fifth angle 09 is non-zero. More precisely, in this example, the fifth angle 09 is equal to - 50°.
[0159] Similarly, the joining portion 656 of the second longitudinal welding zone 65 has an edge which forms a sixth non-zero angle 010 relative to a second longitudinal axis Y2 of the pocket 1. The second longitudinal axis Y2 extends parallel to the second edge 15 passing through the second longitudinal welding zone 65. The joining portion 656 of the second longitudinal welding zone 65 widens towards one side of the second longitudinal axis Y2 where the second compartment 12 is located.
[0160] The second angle 010 is symmetrical to the first angle 09, with respect to a longitudinal axis of symmetry.
[0161] The sixth angle 010 is in a range from 0 to +70°. Preferably, the sixth angle 010 is less than or equal to +50°. Preferably, the sixth angle 010 is greater than or equal to +20°.
[0162] In the example illustrated in [Fig.4], the sixth angle 010 is non-zero. More precisely, in this example, the sixth angle 010 is equal to + 50°.
[0163] The flared shape of the joining portions 643, 653, 646, 656 of the longitudinal welding zones 64, 65 guides the flow of the first medical substance inside the second compartment 12, so as to generate a vortex T inside the second compartment 12 (as illustrated by the arrows). The vortex T increases the efficiency of the mixing between the first substance and the second substance in the second compartment 12. Indeed, the vortex promotes the circulation of the first medical substance throughout the volume of the second compartment 12.
[0164] In addition, each longitudinal weld zone 64, 65 has, in its joining portion 643, 653, a non-welded relief zone 644, 654, each relief zone 644, 654 being completely surrounded by the weld.
[0165] Furthermore, each longitudinal welding zone 64, 65 has, in its portion of junction 646, 656 a non-welded relief area 647, 657, each relief area 647, 657 being completely surrounded by the weld.
[0166] As illustrated in [Fig.5], to prepare a medicinal solution from the bag 1, the first compartment 11 can be manually pressed so as to generate an increase in pressure in the first compartment 11 until the separating weld zone 68 breaks.
[0167] For this purpose, the pocket 1 can be folded along the transverse axis X, then pressed into the folded position.
[0168] The rupture of the separating weld zone 68 has the effect of putting the first compartment 11 into communication with the second compartment 12.
[0169] Then, the pocket 1 can be unfolded.
[0170] By continuing to apply pressure to the first compartment 11, the pressure exerted on the first compartment 11 causes the first medical substance to penetrate into the second compartment 12, where the first medical substance mixes with the second medical substance.
[0171] The shape of the junction portions 643 and 653 of the first and second longitudinal welds 64 and 65 makes it possible, on the one hand, to concentrate the stresses on the separating weld zone 68 when a pressure P is exerted on the first compartment 11 (as illustrated by the arrows in [Fig. 4], in the first compartment 11), so as to promote a repeatable and controlled rupture of the separating weld zone 68.
[0172] On the other hand, this shape of the junction portions 643 and 653 of the first and second longitudinal welds 64 and 65 also makes it possible to create a Venturi effect, once the separating weld zone 68 has been broken, which accelerates the speed of the flow of the first medical substance when the first medical substance enters the second compartment 12.
[0173] In addition, the flared shape of the portions 643, 653, 646 and 656 guides the flow of the first medical substance inside the second compartment 12, so as to form a vortex inside the second compartment 12 (as illustrated by the arrows in Figures 3 and 4, in the second compartment 12). The vortex phenomenon increases the efficiency of the mixing between the first substance and the second substance. Indeed, the vortex promotes the circulation of the first medical substance throughout the volume of the second compartment 12.
[0174] Finally, the edges 649 and 659 provide a funnel shape that facilitates the flow of the medical substance (consisting of the mixture of the first medical substance and the second medical substance) from the second compartment 12 to the first compartment 11, during the administration of the medical substance. In other words, the inclined edges 649 and 659 prevent retention of a portion of the medical substance in the second compartment 12 when emptying the bag.
[0175] [Fig.6] schematically represents a bag 1 according to a third possible embodiment, in which the bag comprises three compartments.
[0176] In this third embodiment, the first wall 2 and the second wall 3 are assembled together by welding in a plurality of welding zones 6. The welding zones 6 delimit a first compartment 11, a second compartment 12 and a third compartment 13.
[0177] The first compartment 11 is intended to contain a first medical substance, the second compartment 12 is intended to contain a second medical substance, and the third compartment 13 is intended to contain a third medical substance.
[0178] 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.
[0179] By way of example, the pouch illustrated in [Fig.6] may be sized such that the first compartment 11 is adapted to contain approximately 80 milliliters of the first medical substance in liquid form, the second compartment 12 is adapted to contain approximately 5 grams of the second medical substance in powder form, and the third compartment 13 is adapted to contain approximately 20 milliliters of the third medical substance in liquid form.
[0180] The second compartment 12 is separated from the first compartment 11 by a first separating weld zone 68. That is to say, the first separating weld zone 68 extends between the first compartment 11 and the second compartment 12. The first separating weld zone 68 prevents penetration of the first medical substance contained in the first compartment 11 towards the second compartment 12, and prevents penetration of the second medical substance contained in the second compartment 12 towards the first compartment 11.
[0181] The third compartment 13 is separated from the first compartment 11 by a second separating weld zone 69. That is to say, the second separating weld zone 69 extends between the first compartment 11 and the third compartment 13. The second separating weld zone 69 prevents penetration of the first medical substance contained in the first compartment 11 into the third compartment 13, and prevents penetration of the third medical substance contained in the third compartment 13 into the first compartment 11.
[0182] The first separating weld zone 68 extends from the first longitudinal weld zone 64 to the second longitudinal weld zone 65. The first separating weld zone 68 extends in a transverse direction, along a transverse axis X of the pocket 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 the first side.
[0183] The first 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 junction 71 between the separating weld zone 68 and the first longitudinal weld zone 64, and a second junction 72 between the separating weld zone 68 and the second longitudinal weld zone 65.
[0184] The separating weld zone 68 has a dimension 1 measured between the first junction 71 and the second junction 72, parallel to the transverse axis X.
[0185] Furthermore, the first compartment 11 has a dimension L measured between the first longitudinal weld 64 and the second longitudinal weld 65, parallel to the transverse axis X. The dimension L corresponds to the maximum spacing between the first longitudinal weld 64 and the second longitudinal weld 65 measured along a transverse axis X passing through the first compartment 11.
[0186] The ratio 1 / L between is in a range from 1 / 3 to 3 / 4, preferably in a range from 1 / 3 to 2 / 3.
[0187] More precisely, in the example illustrated in [Fig.6], the ratio 1 / L is equal to 0.65.
[0188] In the example illustrated in [Fig.6], 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 a respective longitudinal weld zone 64, 65.
[0189] In the example illustrated in [Fig.6], the central portion 681 of the first separating weld zone 68 is rectilinear. The central portion 681 extends parallel to the transverse axis X of the pocket 1.
[0190] In the example illustrated in [Fig.6], the central portion 681 of the separating weld zone 68 has a constant thickness el.
[0191] In addition, the thickness el of the central portion 681 of the separating weld zone 68 is less than a thickness e4, e5 of each of the lateral portions 684, 685 of the separating weld zone 68.
[0192] Each lateral portion 684, 685 of the first separating weld zone 68 flares out, forming a non-zero angle relative to the transverse axis X, on each side of the transverse axis.
[0193] The first lateral portion 684 of the first separating weld zone 68 flares from the central portion 681 towards the first longitudinal weld zone. 64.
[0194] Similarly, the second lateral portion 685 of the first separating weld zone 68 flares from the central portion 681 towards the second longitudinal weld zone 65.
[0195] In other words, each lateral portion 684, 685 has a thickness e4, e5 which increases continuously from the central portion 681 to a respective longitudinal welding zone 64, 65.
[0196] In the example illustrated in [Fig.6], each lateral portion 684, 685 has an edge which forms a non-zero angle 06 with respect to the transverse axis X, on the first side of the transverse axis where the first compartment 11 is located, and another edge which forms a non-zero angle 07 with respect to the transverse axis X, on the second side of the transverse axis X where the second compartment 12 is located.
[0197] More precisely, the first lateral portion 684 of the separating weld zone 68 flares out, forming a first non-zero angle 06 on the first side of the transverse axis X where the first compartment 11 is located.
[0198] The second lateral portion 685 of the separating weld zone 68 flares out, forming a second non-zero angle 07 on the first side of the transverse axis X where the first compartment 11 is located.
[0199] The first lateral portion 684 of the separating weld zone 68 flares out, forming a third non-zero angle 04 on the second side of the transverse axis X where the second compartment 12 is located.
[0200] The second lateral portion 685 of the separating weld zone 68 flares out, forming a fourth non-zero angle 05 on the second side of the transverse axis X where the second compartment 12 is located.
[0201] Furthermore, in the embodiment illustrated in [Fig.6], the first non-zero angle 06 is symmetrical to the third non-zero angle 07, with respect to a longitudinal axis of symmetry. The second non-zero angle 04 is symmetrical to the fourth non-zero angle 05, with respect to a longitudinal axis of symmetry.
[0202] Furthermore, the first longitudinal welding zone 64 and the second longitudinal welding zone 65 each comprise a first portion 641, 651 delimiting the first compartment 11 and a second position 642, 652 delimiting the second compartment 12.
[0203] 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, greater than the first thickness e6.
[0204] Similarly, the first portion 651 of the second longitudinal welding zone 65 has a first thickness e9 and the second portion 652 of the second zone of longitudinal weld 65 has a second thickness el0, greater than the first thickness e9.
[0205] In addition, as illustrated in [Fig.6], the first longitudinal weld zone 64 has a joining portion 643 connecting the first portion 641 to the second portion 642 of the first longitudinal weld zone 64. The joining portion 643 widens from the first portion 641 to the second portion 642. The joining portion 643 has a thickness e8 which increases continuously from the first portion 641 to the second portion 642 of the first longitudinal weld zone 64.
[0206] In addition, 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 08 relative to the transverse axis X.
[0207] The first angle θ is in a range from 0 to +70°. Preferably, the first angle θ is less than or equal to +50°. Preferably, the first angle θ is greater than or equal to +20°.
[0208] In the example illustrated in [Fig.6], the first angle 08 is non-zero. More precisely, in this example, the first angle 08 is equal to + 50°.
[0209] Similarly, the second longitudinal weld zone 65 has a joining portion 653 connecting the first portion 651 to the second portion 652 of the second longitudinal weld zone 65. The joining portion 653 widens from the first portion 651 to the second portion 652. The joining portion 653 has a thickness el 1 which increases continuously from the first portion 651 to the second portion 652 of the second longitudinal weld zone 65.
[0210] In addition, the joining portion 653 connects the first portion 651 to a second end of the separating weld zone 68, opposite the first end. The joining portion 653 has an edge 658 which delimits the first compartment 11 and which forms a second non-zero angle 011 with respect to the transverse axis X.
[0211] The second angle 011 is symmetrical to the first angle 08, with respect to a longitudinal axis of symmetry.
[0212] Thus, the second angle 011 is within a range from -70° to 0. Preferably, the second angle 011 is greater than or equal to -50°. Preferably, the second angle 011 is less than or equal to -20°.
[0213] In the example illustrated in [Fig.3], the second angle 011 is non-zero. More precisely, in this example, the second angle 011 is equal to - 50°.
[0214] In the example illustrated in [Fig.6], each flared junction portion 643, 653 has an edge 648, 658 respectively forming a non-zero angle 08, 011 relative to the transverse axis X, on the first side of the transverse axis X where the first com- section 11.
[0215] In addition, each longitudinal weld zone 64, 65 has, in its flared joining portion 643, 653, a non-welded relief zone 644, 654, each relief zone 644, 654 being completely surrounded by the weld.
[0216] Each longitudinal weld zone 64, 65 further has, in its second portion 642, 652, a non-welded relief zone 645, 655, each relief zone 645, 655 being completely surrounded by the weld.
[0217] These saving zones 644, 654, 645, 655 make it possible to avoid generating folds in the polymer films of the walls when welding the first wall 2 and the second wall 3 together.
[0218] The second separating weld zone 69 extends from the first transverse weld zone 66 to the second longitudinal weld zone 65.
[0219] The second separating weld zone 69 has a thickness el2 which is substantially constant from the first transverse weld zone 66 to the second longitudinal weld zone 65.
[0220] The second separating weld zone 69 comprises 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 to each other. The first portion 691 has a substantially rectilinear shape. The second portion 692 also has a substantially rectilinear shape. The third portion 693 has a curved shape. More precisely, the third portion 693 has a curvature having a convex side and a concave side, the first compartment 11 being located on the convex side of the curvature and the third compartment 13 being located on the concave side of the curvature.
[0221] The second separating weld zone 69 is also a peelable weld zone.
[0222] The bag 1 further comprises a first filling tube 4 and a second filling tube 10.
[0223] The first filling tube 4 is arranged between the first wall 2 and the second wall 3 through the first transverse welding zone 65, so as to allow filling of the first compartment 11 with the first medical substance via the first filling tube 4.
[0224] The second filling tube 10 is arranged between the first wall 2 and the second wall 3 through the first transverse welding zone 65, so as to allow filling of the third compartment 13 with the third medical substance via the second filling tube 10.
[0225] Once the first compartment 11 has been filled with the first substance medical, the first filling tube 4 can be permanently closed, for example, by a plug or a weld.
[0226] Once the third compartment 13 has been filled with the third medical substance, the second filling tube 10 can be closed by a connector.
[0227] [Fig.7] schematically represents a pocket 1 conforming to a fourth possible embodiment.
[0228] By way of example, the pouch illustrated in [Fig.7] may be sized such that the first compartment 11 is adapted to contain approximately 40 milliliters of the first medical substance in liquid form, the second compartment 12 is adapted to contain approximately 100 grams of the second medical substance in powder form, and the third compartment 13 is adapted to contain approximately 10 milliliters of the third medical substance in liquid form.
[0229] The intravenous infusion bag 1 illustrated in [Fig.7] has characteristics identical to those of the bag illustrated in [Fig.6], except that the compartments 11, 12 and 13 have different capacities.
[0230] The first 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 junction 71 between the separating weld zone 68 and the first longitudinal weld zone 64, and a second junction 72 between the separating weld zone 68 and the second longitudinal weld zone 65.
[0231] The separating weld zone 68 has a dimension 1 measured between the first junction 71 and the second junction 72, parallel to the transverse axis X.
[0232] 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.
[0233] This dimension L corresponds to the maximum spacing between the first longitudinal weld 64 and the second longitudinal weld 65 measured along a transverse axis X passing through the first compartment 11.
[0234] In the example illustrated in [Fig.7], the axis parallel to the transverse axis X passes through both the first compartment 11 and the third compartment 13.
[0235] The ratio 1 / L is in a range from 1 / 3 to 3 / 4.
[0236] The ratio 1 / L between is in a range from 1 / 3 to 3 / 4, preferably in a range from 1 / 3 to 2 / 3.
[0237] More precisely, in the example illustrated in [Fig.7], the ratio 1 / L is equal to 0.65.
[0238] To prepare a medicinal solution from bag 1, the third com compartment 13 can be manually pressed so as to generate an increase in pressure in the third compartment 13 until it causes a rupture of the second separating weld zone 69.
[0239] The rupture of the second separating weld zone 69 has the effect of putting the third compartment 13 into communication with the first compartment 11.
[0240] In other words, once the second separating weld zone 69 is broken, the two compartments 11 and 13 then form a single compartment 11 + 13 containing a mixture of the first medical substance and the third medical substance.
[0241] Thus, in the remainder of the preparation process, the bag 1 can be used as a two-compartment bag.
[0242] According to a second step, the compartment containing the mixture can be pressed manually so as to generate an increase in the pressure in the compartment 11 + 13 until it causes a rupture of the separating weld zone 68.
[0243] For this purpose, the pocket 1 can be folded along the transverse axis X, then pressed into the folded position.
[0244] The rupture of the first separating weld zone 68 has the effect of putting the compartment 11 + 13 into communication with the second compartment 12.
[0245] Then, the pocket 1 can be unfolded.
[0246] By continuing to apply pressure to the compartment 11 + 13, the pressure exerted on the compartment 11 + 13 causes the first medical substance to penetrate into the second compartment 12, where the mixture consisting of the first medical substance and the second medical substance mixes with the third medical substance. Example :
[0247] Several pockets 1 were tested with the parameters mentioned in Table 1.
[0248] Each tested pouch comprises a first compartment 11 containing approximately 100 milliliters of a first liquid substance and a second compartment containing approximately 5 grams of a second solid substance in powder form.
[0249] The first compartment 11 was pressed so as to obtain an increase in pressure of the first substance contained in the first compartment 11 of approximately 0.6 bars.
[0250] The presence of “dead zones” means that there remains in the second compartment 12 powder not mixed with liquid. This means that the mixing is not sufficiently effective.
[0251] The extent of the breakage of the peelable seal was observed to determine whether this breakage was sufficient to allow sufficient liquid flow from the first compartment 11 to the second compartment 12.
[0252] The pressure drop of the liquid flow entering the second compartment 12 has been estimated. Too great a pressure drop prevents the liquid from entering the second compartment with a sufficient flow rate to ensure good efficiency of the mixture between liquid and powder.
[0253] [Tableauxl] Pocket L (mm) 1 (mm) 1 / L 08 (=-911) Dead zones Peelable weld break Pressure drop 1 100 33 0.33 0° YES Complete Very high 2 100 33 0.33 85° NO Incomplete Negligible 3 100 50 0.50 0° YES Complete High 4 100 50 0.50 45° NO Complete Medium 5 100 50 0.50 70° NO Incomplete Low 6 100 50 0.50 85° NO Incomplete Negligible
[0254] The distribution of stresses on the peelable weld zone is sufficiently homogeneous when the ratio 1 / L is less than or equal to 3 / 4. This homogeneous distribution makes it possible to obtain a complete rupture of the peelable weld zone.
[0255] Conversely, when the ratio 1 / L becomes greater than 3 / 4, the stresses exerted on the peelable weld zone are no longer distributed homogeneously along the peelable weld zone. In this case, the rupture of the peelable weld zone is incomplete, which does not allow precise control of the location of the rupture and causes a significant pressure drop in the flow of liquid which enters the second compartment 12.
[0256] On the other hand, a 1 / L ratio of less than 1 / 3 results in the peelable seal area becoming difficult to break. In this case, the extent of the breakage of the peelable seal area may also be incomplete, which does not allow generating a sufficient flow rate of the first medical substance entering the second compartment to ensure complete and homogeneous mixing with the second medical substance.
[0257] Furthermore, the presence of non-zero angles 08 and 011 makes it possible to guide the flow of liquid and thus to reduce the pressure loss generated by the passage of the liquid towards the second compartment through the opening created in the peelable weld zone.
[0258] However, a value of the angle 08 that is too high (greater than + 70°) has the effect of cancelling out the benefits provided by the ratio 1 / L less than or equal to 3 / 4.
Claims
1.
2.
3. Claims Bag intended to contain medical substances for intravenous injection (1), comprising: - a first wall (2), and - a second wall (3), the first wall (2) and the second wall (3) being assembled together by welding zones (6), the welding zones (6) delimiting 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, in which the welding zones (6) include: - a first permanent welding zone (64) extending along a first longitudinal edge (14) of the pocket (1), - a second permanent welding zone (65) extending along a second longitudinal edge (15) of the pocket (1), opposite the first longitudinal edge (14), and - a third peelable weld zone (68) separating the first compartment (11) from the 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 junction (71) between the third peelable weld zone (68) and the first permanent weld zone (64), and a second junction (72) between the third peelable weld zone (68) and the second permanent weld zone (65), and wherein a ratio 1 / L between a dimension 1 of the third peelable weld zone (68) measured between the first junction (71) and the second junction (72) along a transverse axis (X), and a dimension L 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), is within a range from 1 / 3 to 3 / 4. Bag (1) according to claim 1, in which the ratio 1 / L is in a range from 1 / 3 to 2 / 3. Pocket (1) according to one of claims 1 and 2, in which the first permanent welding zone (64) comprises a first longitudinal portion (641) extending parallel to the first edge. longitudinal edge (14) of the pocket (1) and a first flared portion (643) extending from the first longitudinal portion (641) to the first junction (71), the first flared portion (643) delimiting the first compartment (11) by forming a first angle (08) in a range from 0° to +70° with a transverse axis (X) extending perpendicular to the longitudinal edges (14, 15), and the second permanent welding zone (65) comprises a second longitudinal portion (651) extending parallel to the second longitudinal edge (15) of the pocket (1) and a second flared portion (653) extending from the second longitudinal portion (651) to the second junction (72), the second flared portion (653) delimiting the first compartment (11) by forming a second angle (011) in a range ranging from -70° to 0 with the transverse axis.
4. A pouch according to claim 3, wherein the first angle (08) is in a range from 0° to +50° relative to the transverse axis (X), and the second angle (011) is in a range from -50° to 0° with the transverse axis (X).
5. A pouch according to either of claims 3 and 4, wherein the first angle (08) is in a range from +20° to +50° relative to the transverse axis, and the second angle (011) is in a range from -50° to -20° relative to the transverse axis (X).
6. Pouch according to one of claims 1 to 5, in which the first permanent welding zone (64) comprises a third longitudinal portion (642) extending parallel to the first longitudinal edge (14) of the pouch (1) and a third flared portion (663) extending from the third longitudinal portion (642) to the first junction (71), the third flared portion (663) delimiting the second compartment (12) by forming a third angle (04) in a range from -70° to 0 with a transverse axis (X) extending perpendicular to the longitudinal edges (14, 15), and the second permanent welding zone (65) comprises a fourth longitudinal portion (652) extending parallel to the second longitudinal edge (15) of the pouch (1) and a fourth flared portion (673) extending from the fourth portion longitudinal (652) to the second junction (72),the fourth flared portion (673) delimiting the second compartment (12) by forming a fourth angle (05) within a range from 0° to + 70° with the transverse axis (X).,
7. A pouch according to claim 6, wherein the third angle (04) is included in a range from - 50° to 0 with respect to the transverse axis (X), and the fourth angle (05) is included in a range from 0° to + 50° with the transverse axis.
8. A pouch according to any one of claims 6 and 7, wherein the third angle (04) is within a range of -50° to -20° relative to the transverse axis, and the fourth angle (05) is within a range of +20° to +50° relative to the transverse axis.
9. Pouch 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 melting the first wall (2) and the second wall (3) at a first temperature, and - the third peelable weld zone (68) has been obtained by melting the first wall (2) and the second wall (3) at a second temperature, lower than the first temperature, so that when the first medical substance is received in the first compartment (11) and pressure is exerted on the first compartment (11), the pressure exerted on the first compartment (11) causes a rupture of the third peelable weld zone (68), thus allowing penetration of the first medical substance into the second compartment (12).
10. Pouch according to one of claims 1 to 9, comprising the first medical substance contained in the first compartment (11).
11. The pouch of claim 10, wherein the first medical substance is a liquid substance.
12. Pouch according to one of claims 1 to 11, comprising the second medical substance contained in the second compartment (12).
13. The pouch of claim 12, wherein the second medical substance is a powder or lyophilisate.
14. A method of preparing a medicinal solution from a pouch (1) according to one of claims 1 to 13, wherein the first compartment (11) of the pouch (1) contains a first medical substance and the second compartment (12) of the pouch (1) contains a second medical substance, the method comprising a step of: - pressing the first compartment (11) so as to cause a rupture of the third peelable seal zone (68), thus allowing penetration of the first medical substance into the second compartment (12).
15. A method of manufacturing a pouch (1), comprising steps of: - welding together a first wall (2) and a second wall (3) in welding zones (6), the welding zones (6) delimiting at least one first compartment (11) intended to receive a first medical substance and at least one second compartment (12) intended to receive a second medical substance, and in which the welding zones (6) include: - a first permanent welding zone (64) extending along a first longitudinal edge (14) of the pocket (1), - a second permanent welding zone (65) extending along a second longitudinal edge (15) of the pocket (1), opposite the first longitudinal edge, and - a third peelable weld zone (68) separating the first compartment (11) from the 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 junction (71) between the third peelable weld zone (68) and the first permanent weld zone (64) and a second junction (72) between the third peelable weld zone (68) and the second permanent weld zone (65), and wherein a ratio 1 / L between a dimension 1 of the third peelable weld zone (68) measured between the first junction (71) and the second junction (72), and a dimension L of the first compartment (11) measured between the first permanent weld (64) and the second permanent weld (65), is in a range from 1 / 3 to 3 / 4.
16. A method according to claim 15, wherein the steps of welding the first wall (2) and the second wall (3) together comprise: - welding the first wall (2) and the second wall (3) in the first permanent welding zone (64) and in the second permanent welding zone (65), by melting 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 in the third peelable welding zone (68), by melting the first wall (2) and the second wall (3) at a second temperature, lower than the first temperature.