Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/10—Bag-type containers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2093—Containers having several compartments for products to be mixed

Definitions

• Bag intended to contain medical substances for intravenous injection
• the invention relates to a bag intended to contain medical substances for intravenous injection, a method for preparing a medicinal solution using such a bag and a method for manufacturing such a bag.
• Bags intended to contain medicinal solutions for intravenous injection are flexible bags which can be connected to tubing allowing parenteral administration of the drug solution to a patient or allowing withdrawal by means of a syringe of the drug solution from the bag for administration to the patient.
• These pockets are generally manufactured by welding two flexible films of polymer materials together.
• These bags can be sterilized by irradiation before aseptic filling and/or by autoclaving after filling.
• the document FR 3 058 638 Al describes a bag for medical use 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 liquid form. powder form.
• the medical bag has a permanent seal around the edge of the pocket and a peelable seal between the two compartments. The peelable seal is intended to be broken when using the bag, so as to put the first compartment and the second compartment into communication in order to mix the first compound and the second compound together just before administration to the patient. .
• 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 medicinal solution just before administration to the patient.
• One objective is to provide a bag intended to contain medical substances for intravenous injection which makes it possible to obtain better control of the mixture between two medical substances.
• a bag intended to contain medical substances for intravenous injection comprising:
• 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 weld zone extending along a first longitudinal edge of the pocket,
• a third peelable weld zone separating the first compartment from the second compartment, in which 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 in which a ratio l/L enters a dimension I of the third zone of peelable weld 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 included in a range from 1/3 to 3/4.
• the specific ratio of dimensions between the third peelable weld zone and the spacing between the two permanent weld zones makes it possible to control the location where the rupture occurs as well as the extent of the rupture, and this in a repeatable manner.
• An l/L ratio greater than 3/4 has the effect that the stress exerted on the third peelable weld zone is not distributed homogeneously along the third peelable weld zone. In this case, he is not possible to precisely control the location where the breakage of the third peelable weld zone occurs, which does not make it possible to favorably localize the flow of the first medical substance which enters the second compartment to guarantee mixing complete and homogeneous with the second medical substance.
• the l/L ratio is included in a range from 1/3 to 2/3.
• the first permanent welding zone comprises a first longitudinal portion 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 included in a range ranging from 0° to + 70° with a transverse axis extending perpendicular to the longitudinal edges
• the second permanent welding 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 included in a range from -70° to 0 with the transverse axis .
• the first angle is included in a range ranging from 0° to + 50° relative to the transverse axis
• the second angle is included in a range ranging from - 50° to 0° with the transverse axis.
• the first permanent welding zone comprises a third longitudinal portion 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 included in a range going from -70° to 0 with a transverse axis extending perpendicular to the longitudinal edges
• the second permanent welding 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 included in a range from 0° to + 70° with the axis transverse.
• the third angle is included in a range ranging from - 50° to 0 relative to the transverse axis
• the fourth angle is included in a range ranging from 0° to + 50° with the transverse axis.
• the third angle is included in a range ranging from - 50° to - 20° relative to the transverse axis
• the fourth angle is included in a range ranging from + 20° to + 50° with the transverse axis.
• the first permanent weld zone and the second permanent weld zone were obtained by melting the first wall and the second wall at a first temperature
• the third peelable weld zone was obtained by melting the first wall and of 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 a rupture of the third peelable weld zone, thus allowing penetration of the first medical substance into the second compartment.
• the bag includes the first medical substance contained in the first compartment.
• the first medical substance is a liquid substance.
• the bag includes the second medical substance contained in the second compartment.
• the second medical substance is a powder or a lyophilisate.
• a medicinal solution can be prepared using a method of preparing a medicinal solution from a bag as defined above, in which the first compartment of the bag contains a first medical substance and the second compartment of the bag contains a second medical substance, the method comprising a step of pressing the first compartment so as to cause a rupture of the third peelable weld zone, thus allowing penetration of the first medical substance into the second compartment.
• a bag as defined above can be manufactured according to a manufacturing process, comprising steps of:
• 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 in which the welding zones include:
• a third peelable weld zone separating the first compartment from the second compartment, in which 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 in which a ratio l/L between a dimension I 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 included in a range from 1/3 to 3/4.
• the steps of welding the first wall and the second wall together may include:
• Figure 1 schematically represents a bag intended to contain medical substances for intravenous injection, seen from the front,
• Figure 2 represents the pocket of Figure 1, seen from behind
• FIG. 3 schematically represents a bag intended to contain medical substances for intravenous injection conforming to a first possible embodiment, before filling,
• FIG. 4 schematically represents a bag intended to contain medical substances for intravenous injection conforming to a second possible embodiment, before filling,
• FIG. 5 schematically represents a step of preparing a medicinal solution from a bag
• FIG. 6 schematically represents a bag intended to contain medical substances for intravenous injection conforming to a third possible embodiment, before filling
• FIG. 7 schematically represents a bag intended to contain medical substances for intravenous injection conforming to a fourth possible embodiment, before filling.
• the pocket 1 shown comprises a first wall 2, a second wall 3, a filling tube 4 and a connector 5.
• 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, separated from the first compartment 11.
• the first compartment 11 contains a first medical substance and the second compartment 12 contains a second medical substance.
• the first medical substance is a liquid substance and the second medical substance is a powder substance or a lyophilisate.
• the powdered substance or the lyophilisate contains for example an active ingredient (such as an antibiotic, an anticancer, an antifungal 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.
• the first wall 2 can be formed of a first film of polymer material, for example a polymer material comprising a polyolefin, such as polypropylene or polyethylene.
• the second wall 3 can be formed from a second film identical to the first film.
• the second wall may be formed of a second film of polymer material, for example a polymer material comprising a polyolefin, such as polypropylene or polyethylene.
• 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 precisely, 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 precisely, the second opening opens outside the pocket 1.
• the filling tube 4 further comprises an internal channel extending from the first opening to the second opening.
• the connector 5 seals the second opening of the filling tube 4 in a sealed manner.
• 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.
• the pocket 1 may further comprise a first protective sheet 7 fixed on the first wall 2 and/or a second protective sheet 8 fixed on the second wall 3.
• 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.
• 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.
• the first protective sheet 7 and the second protective sheet 8 each form a barrier which prevents moisture penetration, 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.
• 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.
• the first protective sheet 7 and/or the second protective sheet 8 can be fixed respectively on the first wall 2 and/or on the second wall 3 by a peelable weld, allowing the first sheet to be removed protective sheet 7 and/or the second protective sheet 8 before using the pocket. Removal of the first protective sheet 7 and/or the second protective sheet 8 can make it possible to visually check the state of the second medical substance contained in the second compartment 12, before proceeding to mix the first medical substance with the second medical substance.
• first protective sheet 7 and/or the second protective sheet 8 can be fixed respectively on the first wall 2 and/or on the second wall 3 by permanent welding. In this case, the first protective sheet 7 and/or the second protective sheet 8 are not removed before using the pocket.
• the first protective sheet 7 and/or the second protective sheet 8 can be transparent to light radiation in the visible range, in order to allow the state of the second medical substance contained in the second compartment 12 to be visually checked.
• the pocket 1 may also have an orifice 9 provided through both the first wall 2 and the second wall 3 in a welding zone, the orifice 9 allowing the pocket 1 to be suspended from a hook during its use.
• the second compartment 12 When the pocket 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.
• Figure 3 schematically represents a pocket 1 conforming to a first embodiment.
• the bag 1 illustrated in Figure 3 can be dimensioned so 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 to several hundred grams of the second medical substance in powder form, for example 100 grams.
• the pocket 1 illustrated in Figure 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.
• the pocket 1 further comprises a plurality of welding zones 6 delimiting the first compartment 11 and the second compartment 12.
• the welding zones 6 include a first longitudinal welding zone 64 extending along the first longitudinal edge 14 and a second longitudinal welding zone 65 extending along the second longitudinal edge 15.
• weld zones 6 also include a first transverse weld zone 66 extending along the first transverse edge 16.
• pocket 1 is shown before filling. That is to say, 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. This is why the welding zones 6 do not yet include a second transverse welding zone extending along the second transverse edge 17.
• 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.
• a second transverse weld zone 67 extending along the second transverse edge 17 can be carried out (the second transverse weld zone 67 is illustrated in dotted lines in Figure 3).
• an orifice 9 can 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.
• 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 welding zones were obtained by subjecting the first wall 2 and the second wall 3 to a first temperature having resulted in a fusion of the first film and the second film between them, so as to obtain a connection permanent of the walls 2 and 3 between them in these welding 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 around 140 to 150 degrees Celsius for 3 seconds.
• 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 that 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.
• 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.
• the second compartment 12 is delimited by the first longitudinal welding zone 64, the second longitudinal welding zone 65, the separating weld zone 68 and the second transverse weld zone 67.
• 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 having resulted in a fusion of the first film and the second film, the second temperature being lower than the first temperature.
• 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.
• the weld can be broken in this area, for example under the effect of pressure exerted on the first compartment 11.
• 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.
• the separating weld zone 68 extends from the first longitudinal weld zone 64 to the second longitudinal weld zone 65.
• 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.
• 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.
• the separator 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 separator 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.
• first junction 71 is the place where the separating weld zone 68 meets the first longitudinal weld zone 64
• the second junction 72 is where the separating weld zone 68 meets the second longitudinal weld 65.
• the separating weld zone 68 has a dimension I measured between the first junction 71 and the second junction 72, parallel to the transverse axis X.
• 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.
• the l/L ratio between is included in a range from 1/3 to 3/4, preferably in a range from 1/3 to 2/3.
• the ratio l/L is equal to 0.65.
• the separating weld zone 68 comprises 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 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 welding zone 65.
• 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.
• the central portion 681 of the separating weld zone 68 has a thickness el less than a thickness e4, e5 of each of the lateral portions 684, 685 of the separating weld zone 68. More precisely, in the example illustrated in Figure 3, the central portion 681 of the separating weld zone 68 has a constant thickness el.
• the first lateral portion 684 of the separating weld zone 68 flares from the central portion 681 towards the first longitudinal weld zone 64.
• the second lateral portion 685 of the separating weld zone 68 flares from the central portion 681 towards the second longitudinal weld zone 65.
• each lateral portion 684, 685 has a thickness e4, e5 which increases continuously from the central portion 681 to a respective longitudinal weld zone 64, 65.
• each lateral portion 684, 685 has an edge which delimits the second compartment 12 and which forms a non-zero angle with respect to the transverse axis X, on the second side of the the transverse axis X where the second compartment 12 is located.
• the first lateral portion 684 flares out, forming a first non-zero angle 04 relative to the transverse axis X.
• the first angle 04 is included in a range from -70° to 0.
• the first angle 04 is greater than or equal to -50°.
• the first angle 04 is less than or equal to -20°.
• the first angle 04 is non-zero. More precisely, in this example, the first angle 04 is equal to - 45°.
• the second lateral portion 685 flares, 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.
• the second angle 05 is included in a range from 0 to + 70°.
• the second angle 05 is less than or equal to + 50°.
• the second angle 05 is greater than or equal to + 20°.
• the first angle 05 is non-zero. More precisely, in this example, the first angle 05 is equal to + 45°.
• the central portion 681 of the separating weld zone 68 constitutes a portion of lower resistance of the separating weld zone 68.
• 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.
• first longitudinal welding zone 64 and the second longitudinal welding zone 65 each comprise a first respective portion 641, 651 delimiting the first compartment 11 and a second respective position 642, 652 delimiting the second compartment 12.
• 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.
• 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 elO, greater than the first thickness e9.
• the first longitudinal weld zone 64 has a junction portion 643 connecting the first portion 641 to the second portion 642 of the first longitudinal weld zone 64.
• the junction portion 643 flares from the first portion 641 to the second portion 642.
• the junction 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.
• the junction portion 643 connects the first portion 641 to a first end of the separating weld zone 68.
• 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
• the first angle 08 is included 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°.
• the first angle 08 is non-zero. More precisely, in this example, the first angle 08 is equal to + 50°.
• the second longitudinal weld zone 65 has a junction portion 653 connecting the first portion 651 to the second portion 652 of the second longitudinal weld zone 65.
• the junction portion 653 flares from the first portion 651 to to the second portion 652.
• the junction portion 653 has a thickness ell which increases continuously from the first portion 651 to the second portion 652 of the second longitudinal weld zone 65.
• junction portion 653 connects the first portion 651 to a second end of the separating weld zone 68, opposite the first end.
• the junction 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.
• the second angle 011 is symmetrical to the first angle 08, relative to a longitudinal axis of symmetry.
• the second angle 011 is included in a range going from
• the second angle 011 is greater than or equal to - 50°.
• the second angle 011 is less than or equal to -20°.
• the second angle 011 is non-zero. More precisely, in this example, the second angle 011 is equal to
• each flared junction portion 643, 653 thus has an edge 648, 658 respectively forming an angle non-zero 08, 011 relative to the transverse axis X, on the first side of the transverse axis X where the first compartment 11 is located.
• 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 repeatable and controlled rupture of the separating weld zone 68.
• this orientation of the edges 648 and 658 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.
• Each longitudinal weld zone 64, 65 has, in its flared junction portion 643, 653, a non-welded spare zone 644, 654, each spare zone 644, 654 being completely surrounded by the weld.
• Each longitudinal weld zone 64, 65 also has, in its second portion 642, 652, a non-welded spare zone 645, 655, each spare zone 645, 655 being completely surrounded by the weld.
• Figure 4 schematically represents a pocket 1 conforming to a second embodiment.
• the bag illustrated in Figure 4 can be dimensioned so 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.
• the first longitudinal weld zone 64 and the second longitudinal weld zone 65 were obtained by fusion of the first wall 2 and the second wall 3 at a first temperature, while the weld zone separator 68 was obtained by melting the first wall 2 and the second wall 3 at a second temperature, lower than the first temperature.
• the separating weld zone 68 extends parallel to the transverse axis X of pocket 1.
• the separating weld zone 68 has a rectilinear shape.
• the separating weld zone 68 has a constant thickness el, along the transverse axis X.
• the first junction portion 643 connects the first portion 641 to the second portion 642 of the first longitudinal weld zone 64.
• the first longitudinal weld 64 comprises a third junction portion 663
• the first junction portion 643 connects the first portion 641 to the third junction portion 663.
• the third junction portion 663 connects the first junction portion 643 to the second portion 642 of the first longitudinal weld zone 64.
• the first junction portion 643 of the first longitudinal weld 64 flares from the first portion 641 to the separating weld zone 68.
• the third junction portion 663 thins from the separating weld zone 68 to the second portion 642 of the first longitudinal weld zone 64.
• junction portion 643 has a thickness e8 which increases continuously from the first portion 641 to the separating weld zone 68 and the junction portion 663 has a thickness e8 which decreases continuously from the separating weld zone 68 until 'to the second portion 642 of the first longitudinal weld zone 64.
• the second longitudinal weld 65 comprises a fourth junction portion 673
• the second junction portion 653 connects the first portion 651 to the fourth junction portion 673.
• the fourth junction portion 673 connects the second junction portion 653 to the second portion 652 of the second longitudinal weld zone 65.
• the second junction 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.
• the fourth junction portion 673 thins from the separating weld zone 68 to the second portion 652 of the second longitudinal weld zone 65.
• junction portion 653 has a thickness which increases continuously from the first portion 651 to the separating weld zone 68 and the junction portion 673 has a thickness which decreases continuously from the separating weld zone 68 until to the second portion 652.
• the separator 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 separator weld zone 68 and the first longitudinal weld zone
• the separating weld zone 68 extends from the junction portion 643 of the first longitudinal weld 64 to the junction portion 653 of the second longitudinal weld 65.
• the separating weld zone 68 has a dimension I measured between the first junction 71 and the second junction 72, parallel to the transverse axis X.
• the first compartment 11 has a dimension L measured between the first longitudinal weld 64 and the second longitudinal weld
• 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.
• the l/L ratio between is included in a range from 1/3 to 3/4, preferably in a range from 1/3 to 2/3.
• the ratio l/L is equal to 0.57.
• 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.
• the first angle 08 is included 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°.
• the first angle 08 is non-zero. More precisely, in this example, the first angle 08 is equal to + 20°.
• junction portion 653 connects the first portion 651 to a second end of the separating weld zone 68, opposite the first end.
• the junction 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.
• the second angle 011 is symmetrical to the first angle 08, relative to a longitudinal axis of symmetry.
• the second angle 011 is included in a range going from -70° to 0.
• the second angle 011 is greater than or equal to -50°.
• the second angle 011 is less than or equal to -20°.
• the second angle 011 is non-zero. More precisely, in this example, the first angle 011 is equal to - 20°.
• 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 . Furthermore, the junction portion 643 has another edge 649 which delimits the second compartment 12 and which forms a third angle 04 with respect to the transverse axis X.
• the third angle 04 is included in a range from -70° to 0.
• the third angle 04 is greater than or equal to -50°.
• the third angle 04 is less than or equal to -20°.
• the third angle 04 is non-zero. More precisely, in this example, the third angle 04 is equal to - 40°.
• junction 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.
• the fourth angle 05 is symmetrical to the third angle 04, relative to a longitudinal axis of symmetry.
• the fourth angle 04 is included in a range from 0 to + 70°.
• the fourth angle 04 is less than or equal to + 50°.
• the fourth angle 05 is greater than or equal to + 20°.
• the fourth angle 05 is non-zero. More precisely, in this example, the fourth angle 05 is equal to + 40°.
• Each junction portion 643, 653 thus has an edge 649, 659 respectively forming a non-zero angle 04, 05 with respect to the transverse axis X, on the second side of the transverse axis X where the second compartment 11 is located.
• each longitudinal weld zone 64, 65 also includes a junction portion 646, 656 which flares from the portion 642, 652 to the second transverse weld 67.
• the junction portion 646 of the first longitudinal weld 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 weld zone 64.
• the junction portion 646 of the first longitudinal weld zone 64 flares towards one side of the first longitudinal axis Y1 where the second compartment 12 is located.
• the fifth angle 09 is included in a range from -70° to 0.
• the fifth angle 09 is greater than or equal to -50°.
• the fifth angle 09 is less than or equal to -20°.
• the fifth angle 09 is non-zero. More precisely, in this example, the fifth angle 09 is equal to - 50°.
• junction portion 656 of the second longitudinal welding zone 65 has an edge which forms a sixth non-zero angle 010 with respect 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 junction portion 656 of the second longitudinal welding zone 65 flares towards one side of the second longitudinal axis Y2 where the second compartment 12 is located.
• the second angle 010 is symmetrical to the first angle 09, relative to a longitudinal axis of symmetry.
• the sixth angle 010 is included in a range from 0 to + 70°.
• the sixth angle 010 is less than or equal to +50°.
• the sixth angle 010 is greater than or equal to + 20°.
• the sixth angle 010 is non-zero. More precisely, in this example, the sixth angle 010 is equal to + 50°.
• each longitudinal weld zone 64, 65 has, in its junction portion 643, 653, a non-welded spare zone 644, 654, each spare zone 644, 654 being completely surrounded by the weld.
• each longitudinal weld zone 64, 65 has, in its junction portion 646, 656, a non-welded spare zone 647, 657, each spare zone 647, 657 being completely surrounded by the weld.
• the first compartment 11 can be pressed manually so as to generate an increase in the pressure in the first compartment 11 until causing a rupture of the zone separator solder 68.
• the pocket 1 can be folded along the transverse axis X and then pressed into the folded position.
• the rupture of the separating weld zone 68 has the effect of putting the first compartment 11 in communication with the second compartment 12.
• pocket 1 can be unfolded.
• 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.
• 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 Figure 4, in the first compartment 11), so as to promote repeatable and controlled rupture of the separating weld zone 68.
• 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.
• 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 swirl phenomenon increases the efficiency of the mixing between the first substance and the second substance. In fact, the swirl promotes the circulation of the first medical substance throughout the volume of the second compartment 12.
• edges 649 and 659 provide a funnel shape which 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 towards the first compartment 11, when than the administration of the medical substance.
• the inclined edges 649 and 659 avoid retention of part of the medical substance in the second compartment 12 when emptying the bag.
• Figure 6 schematically represents a pocket 1 conforming to a third possible embodiment, in which the pocket comprises three compartments.
• 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.
• the first compartment 11 is intended to contain a first medical substance
• the second compartment 12 is intended to contain a second medical substance
• the third compartment 13 is intended to contain a third medical substance.
• the first medical substance is a liquid substance
• the second medical substance is a powder or lyophilisate
• the third substance is a liquid substance.
• the bag illustrated in Figure 6 can be dimensioned so 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.
• the second compartment 12 is separated from the first compartment 11 by a first separating weld zone 68. That is to say that 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.
• the third compartment 13 is separated from the first compartment 11 by a second separating weld zone 69. That is to say that 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 towards the third compartment 13, and prevents penetration of the third medical substance contained in the third compartment 13 towards the first compartment 11.
• the first separator weld zone 68 extends from the first longitudinal weld zone 64 to the second longitudinal weld zone 65.
• the first separator weld zone 68 extends in a transverse direction, along an axis transverse X of the pocket 1.
• the transverse axis X extends between the first compartment 11 and 7 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.
• the first separator 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 separator weld zone 68 and the first weld zone longitudinal 64, and a second junction 72 between the separating weld zone 68 and the second longitudinal weld zone 65.
• the separating weld zone 68 has a dimension I measured between the first junction 71 and the second junction 72, parallel to the transverse axis X.
• 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.
• the l/L ratio between is included in a range from 1/3 to 3/4, preferably in a range from 1/3 to 2/3.
• the ratio l/L is equal to 0.65.
• the first separating weld zone 68 comprises a central portion 681 and two side portions 684 and 685 arranged on either side of the central portion 681.
• Each side portion 684, 685 is extends from the central portion 681, to a respective longitudinal weld zone 64, 65.
• 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.
• the central portion 681 of the separating weld zone 68 has a constant thickness el.
• 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.
• Each lateral portion 684, 685 of the first separating weld zone 68 flares forming a non-zero angle with respect to the transverse axis X, on each side of the transverse axis.
• 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.
• 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.
• each lateral portion 684, 685 has a thickness e4, e5 which increases continuously from the central portion 681 to a respective longitudinal weld zone 64, 65.
• 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 is located 11, 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.
• first lateral portion 684 of the separating weld zone 68 flares, forming a first non-zero angle 06 on the first side of the transverse axis X where the first compartment 11 is located.
• 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.
• 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.
• 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.
• the first non-zero angle 06 is symmetrical with the third non-zero angle 07, relative to a longitudinal axis of symmetry.
• the second non-zero angle 04 is symmetrical fourth non-zero angle 05, relative to a longitudinal axis of symmetry.
• 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.
• 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.
• 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 elO, greater than the first thickness e9.
• the first longitudinal weld zone 64 has a junction portion 643 connecting the first portion 641 to the second portion 642 of the first longitudinal weld zone 64.
• the junction portion 643 flares from the first portion 641 to the second portion 642.
• the junction 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.
• junction portion 643 connects the first portion 641 to a first end of the separating weld zone 68.
• 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
• the first angle 08 is included in a range from 0 to + 70°.
• the first angle 08 is less than or equal to + 50°.
• the first angle 08 is greater than or equal to + 20°.
• the first angle 08 is non-zero. More precisely, in this example, the first angle 08 is equal to + 50°.
• the second longitudinal weld zone 65 has a junction portion 653 connecting the first portion 651 to the second portion 652 of the second longitudinal weld zone 65.
• the junction portion 653 flares from the first portion 651 to to the second portion 652.
• the junction portion 653 has a thickness ell which increases continuously from the first portion 651 to the second portion 652 of the second longitudinal weld zone 65.
• junction portion 653 connects the first portion 651 to a second end of the separating weld zone 68, opposite the first end.
• the junction 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.
• the second angle 011 is symmetrical to the first angle 08, relative to a longitudinal axis of symmetry.
• the second angle 011 is included in a range going from
• the second angle 011 is greater than or equal to - 50°.
• the second angle 011 is less than or equal to -20°.
• the second angle 011 is non-zero. More precisely, in this example, the second angle 011 is equal to
• each flared junction portion 643, 653 has an edge 648, 658 respectively forming a non-zero angle 08, 011 with respect to the transverse axis X, on the first side of the axis transverse X where the first compartment 11 is located.
• each longitudinal weld zone 64, 65 presents, in its flared junction portion 643, 653, a savings zone 644, 654 not welded, each savings zone 644, 654 being completely surrounded by the weld.
• Each longitudinal weld zone 64, 65 also has, in its second portion 642, 652, a non-welded spare zone 645, 655, each spare zone 645, 655 being completely surrounded by the weld.
• the second separating weld zone 69 extends from the first transverse weld zone 66 to the second longitudinal weld zone 65.
• the second separating weld zone 69 has a substantially constant thickness el2 from the first transverse weld zone 66 to the second longitudinal weld zone 65.
• 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 between them.
• 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.
• the second separating weld zone 69 is also a peelable weld zone.
• the pocket 1 further comprises a first filling tube 4 and a second filling tube 10.
• 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.
• 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 .
• the first filling tube 4 can be closed permanently, for example, by a plug or welding.
• the second filling tube 10 can be closed by a connector.
• Figure 7 schematically represents a pocket 1 conforming to a fourth possible embodiment.
• the bag illustrated in Figure 7 can be dimensioned so 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.
• the intravenous infusion bag 1 illustrated in Figure 7 has characteristics identical to those of the bag illustrated in Figure 6, except that the compartments 11, 12 and 13 have different capacities.
• the first separator 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 separator weld zone 68 and the first weld zone longitudinal 64, and a second junction 72 between the separating weld zone 68 and the second longitudinal weld zone 65.
• the separating weld zone 68 has a dimension I measured between the first junction 71 and the second junction 72, parallel to the transverse axis X.
• 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.
• 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.
• axis parallel to the transverse axis X passes both through the first compartment 11 and through the third compartment 13.
• the l/L ratio is included in a range from 1/3 to 3/4.
• the l/L ratio between is included in a range from 1/3 to 3/4, preferably in a range from 1/3 to 2/3.
• the ratio l/L is equal to 0.65.
• the third compartment 13 can be pressed manually so as to generate an increase in the pressure in the third compartment 13 until causing a rupture of the second separating weld zone 69.
• the rupture of the second separating weld zone 69 has the effect of placing the third compartment 13 in communication with the first compartment 11.
• 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.
• bag 1 can be used as a bag with two compartments.
• the compartment containing the mixture can be pressed manually so as to generate an increase in the pressure in compartment 11 + 13 until it causes a rupture of the separating weld zone 68.
• the pocket 1 can be folded along the transverse axis X and then pressed into the folded position.
• the rupture of the first separating weld zone 68 has the effect of placing compartment 11 + 13 in communication with the second compartment 12.
• pocket 1 can be unfolded.
• compartment 11 + 13 By continuing to apply pressure on compartment 11 + 13, the pressure exerted on compartment 11 + 13 causes penetration of the first medical substance into the second compartment 12, where the mixture consisting of the first medical substance and the second substance medical substance mixes with the third medical substance.
• Each bag tested 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.
• 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.
• the distribution of stresses on the peelable weld zone is sufficiently homogeneous when the l/L ratio is less than or equal to 3/4. This homogeneous distribution makes it possible to obtain a complete break of the peelable weld zone.
• an l/L ratio of less than 1/3 has the effect that the peelable weld zone becomes difficult to break.
• the extent of the breakage of the peelable solder zone may also be incomplete, making it impossible to generate a sufficient flow rate of the first medical substance entering the second compartment to ensure complete mixing and homogeneous with the second medical substance.
• the presence of non-zero angles 08 and 011 makes it possible to guide the flow of liquid and thus reduce the pressure loss generated by the passage of the liquid towards the second compartment through the opening created in the welding zone peelable.
• a value of angle 08 that is too high has the effect of canceling the benefits provided by the l/L ratio less than or equal to 3/4.

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• Health & Medical Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Hematology (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Bag Frames (AREA)
• Packages (AREA)
• Package Specialized In Special Use (AREA)

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• 2022
  • 2022-03-23 FR FR2202581A patent/FR3133745B1/fr active Active
• 2023
  • 2023-03-23 AU AU2023241262A patent/AU2023241262A1/en active Pending
  • 2023-03-23 CN CN202380042569.1A patent/CN119255779A/zh active Pending
  • 2023-03-23 CA CA3246298A patent/CA3246298A1/fr active Pending
  • 2023-03-23 WO PCT/FR2023/050417 patent/WO2023180671A1/fr not_active Ceased
  • 2023-03-23 US US18/848,316 patent/US20250205114A1/en active Pending
  • 2023-03-23 KR KR1020247035069A patent/KR20250010585A/ko active Pending
  • 2023-03-23 EP EP23718657.2A patent/EP4496548A1/de active Pending
  • 2023-03-23 JP JP2024555970A patent/JP2025513107A/ja active Pending
• 2024
  • 2024-09-20 MX MX2024011613A patent/MX2024011613A/es unknown
  • 2024-10-18 CO CONC2024/0014233A patent/CO2024014233A2/es unknown

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