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WO2025202215A1 - Sac rempli d'un fluide médical et son procédé de production - Google Patents

Sac rempli d'un fluide médical et son procédé de production

Info

Publication number
WO2025202215A1
WO2025202215A1 PCT/EP2025/058158 EP2025058158W WO2025202215A1 WO 2025202215 A1 WO2025202215 A1 WO 2025202215A1 EP 2025058158 W EP2025058158 W EP 2025058158W WO 2025202215 A1 WO2025202215 A1 WO 2025202215A1
Authority
WO
WIPO (PCT)
Prior art keywords
weld seam
bag
peel
filled
chamber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2025/058158
Other languages
German (de)
English (en)
Inventor
Torsten Brandenburger
Michael SCHÖNHOFEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of WO2025202215A1 publication Critical patent/WO2025202215A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2024—Separating means having peelable seals
    • 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

  • the invention relates to a bag filled with a medical fluid.
  • the invention relates to a three-chamber bag containing an enteral or parenteral nutritional composition.
  • the invention further relates to a method for producing a medical bag.
  • Foil pouches are often used for enteral or parenteral nutritional compositions.
  • Such a foil pouch is equipped with at least one withdrawal port. This can be pierced with a spike or needle, allowing the nutritional composition to be transferred to the patient using a transfer set.
  • Such nutritional compositions typically comprise a glucose-containing solution, an amino acid-containing solution, and a fat emulsion. However, these components can only be stored separately for extended periods.
  • the published patent application WO 2006/010410 A1 shows a three-chamber bag made of welded films. The bag is divided into three chambers by peel-weld seams. The largest chamber, which is usually filled with the glucose-containing solution, extends over the other two chambers in the upper area of the bag.
  • the peel-weld seams are These are weld seams which tear open when pressure is applied to the bag, in particular by rolling the bag up, in particular laterally, preferably from top to bottom, so that the contents of the three chambers can mix.
  • the medical bag described in the above document comprises peel seams with an S-shaped zone which supports the initial tearing of the peel welds.
  • Peel welds differ from other or permanent welds in that the material is less liquefied during welding, for example due to a lower welding temperature and/or a shorter contact time.
  • the peel seals must be sufficiently strong to prevent accidental tearing of the peel seals during transport, thus opening the chambers.
  • the peel seals should also be designed in such a way that the user does not have to exert excessive force, for example, when rolling the bag to exert sufficient pressure to open the peel seals.
  • the volume of medical fluid in the pouch is smaller, usually less than 2000 ml.
  • the peel seals should open all the way down to the lower transverse seal where the dispensing port is located. This is the only way to ensure a thorough mixing of the various components of the food composition. This is the case with This is particularly important for pediatric applications, as the contents of the bag may only be partially used.
  • the object of the invention is already achieved by a bag filled with a medical liquid and by a method for producing a bag filled with a medical liquid according to one of the independent claims.
  • the invention relates to a bag filled with a medicinal liquid, which is formed from two films, which are provided with a lower transverse weld seam and an upper transverse weld seam and with a first
  • the invention is based on the finding that, via a first peel weld seam, which comprises a curved tear zone which is higher in relation to the lower transverse weld seam than a second tear zone of the second peel weld seam, the first peel weld seam can be opened up to the lower transverse weld seam when used as intended, before the second transverse weld seam begins to tear open.
  • the first peel weld seam is designed in particular in such a way that it begins further to the right at the lower transverse weld seam than the second peel weld seam.
  • an inflection point of the first peel weld is higher than an inflection point of the second peel weld.
  • the beginning of the first curved tear zone is preferably located higher than the beginning of the second tear zone.
  • the beginning of a tear zone is defined in particular by a straight section of the first and second peel weld seams transitioning into a curve.
  • the turning point of the first tear zone of the first peel weld seam is 5 - 150 mm, preferably 10 - 30 mm, particularly preferably 15 - 25 mm, starting from the lower transverse weld seam, higher than the turning point of the second tear zone of the second peel weld seam.
  • the first curved tear zone and/or the second curved Tear zone formed from a first curvature, which merges into a second opposite curvature.
  • the first curvature has a smaller inner radius and/or a smaller outer radius than the second curvature.
  • the first peel weld seam is in particular designed such that it has a lower straight section.
  • the lower straight section starts from the lower transverse weld seam and extends upwards in particular substantially parallel, preferably parallel, to the longitudinal weld seams.
  • the lower, straight section then transitions into an upper, straight section via the first tear-open zone.
  • This upper, straight section also runs essentially parallel, preferably parallel, to the longitudinal weld seams.
  • the upper straight section then runs over a third bend to the second longitudinal weld seam.
  • the third bend provides a left-hand bend.
  • the third bend is preferably formed as a 90° bend and/or a quarter circle. After the third bend, the first peel weld runs transversely to the upper straight section of the first peel weld.
  • the first peel weld seam runs after the third bend over a straight line region running essentially parallel, preferably parallel, to the lower transverse weld seam and/or to the upper transverse weld seam up to the second longitudinal weld seam.
  • the lower straight section starts from the lower transverse weld seam and initially runs upwards to the second tear zone.
  • the second peel weld seam ends or opens in the preferably horizontal, straight region of the first peel weld seam.
  • the bag is thus divided into three chambers, with the first chamber extending from the lower cross-weld seam to the upper cross-weld seam and over the second chamber and the third chamber.
  • the first chamber is thus particularly angularly shaped, with one leg, particularly the right one, extending from the lower transverse weld seam to the upper transverse weld seam.
  • the other leg extends from the first longitudinal weld seam to the second longitudinal weld seam and thus partially over the second chamber and the third chamber.
  • the second chamber and the third chamber preferably extend over one-third to two-thirds of the height of the first chamber.
  • two, in particular three ports are arranged in the lower transverse weld seam, each of which is connected to one of the three chambers.
  • the ports can be used to fill the chambers of the medical bag.
  • At least one first port is provided, which is designed as a withdrawal port.
  • This can comprise a sealing element, in particular a so-called stopper, which can be pierced by a needle or a spike in order to to remove medical fluid and transfer it to the patient, for example via a transfer system.
  • a second port can be designed as an injection port.
  • This also includes a pierceable sealing element, in particular a so-called septum, through which medications or additives can be transferred into the bag, for example, using a syringe.
  • a third port preferably designed as a blind port. This serves only to fill one chamber of the bag and is closed with a plug and a cap.
  • the withdrawal and/or injection ports are preferably designed as connectors.
  • the connector serves to connect a transfer set to the withdrawal port, for example, by opening the withdrawal port using a spike of the transfer set.
  • a pharmaceutical and/or an additive can be transferred into the bag at the injection port, for example, using a needle syringe.
  • the injection port can also be designed as a threadless Luer connector or as a Luer-Lock connector with a thread, and can be used with a suitable syringe, e.g., a Luer or Luer-Lock syringe.
  • the bag is preferably placed in a sterile secondary packaging.
  • the bag is placed in a tear-open bag.
  • the bag is filled with 500 - 2000 ml of medical liquid, in particular with 800 - 1200 ml, preferably with 900 - 1100 ml or with 1300 - 1700 ml, preferably with 1400 - 1600 ml, of medical liquid.
  • this refers to the total amount of medicinal fluid in the three chambers.
  • the bag is preferably designed in such a way that when the bag is rolled up from top to bottom, in particular from top right to bottom left or sideways, the first peel weld seam in the area of the first tear-open zone initially begins to tear open.
  • the bag is preferably designed such that when the bag is rolled up from top to bottom, in particular from top right to bottom left, the first peel weld seam tears open as far as the lower transverse weld seam during intended use, in particular with the second peel weld seam only beginning to tear open at the second tear zone thereafter. This allows for the optional use of the third chamber component.
  • the right and left sides of the bag are defined, in particular, when the bag is stored with its back on a table.
  • the peel seams of the bag are opened by rolling the bag from the top right to the bottom left.
  • the top side of the bag is defined, in particular, by the position of the hanger and the hanging of the bag from a stand via its hanger.
  • the bag has a ratio of height h to width b of 0.7 - 1.5, preferably 0.8 - 1.2.
  • the bag may have a ratio of h to b of 1.0 - 1.2 or of 0.8 - 1.0.
  • the first curvature of the first peel weld and/or the second peel weld may have an inner radius of 2 - 4 mm and/or an outer radius of 8 - 12 mm.
  • the second curvature of the first peel weld and/or the second peel weld may have an inner radius of 10 - 16 mm and/or an outer radius of 15 - 20 mm.
  • the tear zone of the first peel weld seam and/or the second peel weld seam is more curved at the first bend than at the second, opposite bend. Tearing of the peel weld seam thus preferably begins in the area of the first bend.
  • the first tear zone has the same course as the second tear zone.
  • the first curvature of the first tear zone begins at a distance of 50 - 70 mm from the lower transverse weld seam.
  • the first curvature of the second tear zone begins at a distance of 35 - 45 mm from the lower transverse weld seam.
  • the peel weld seams have a width of 5 to 9 mm, in particular 6 to 8 mm.
  • the first chamber is preferably filled with a glucose component.
  • the first chamber can contain 0.4–0.7 times, in particular 0.5–0.7 times, the volume of the medicinal fluid.
  • the second chamber is preferably filled with an amino acid component.
  • the second chamber can contain 0.2–0.4 times, in particular 0.35–0.4 times, the volume of the medicinal liquid.
  • the third chamber is preferably filled with a fat component, in particular a fat emulsion.
  • the third chamber can contain 0.05–0.15 times, in particular 0.08–0.14 times, the volume of the medicinal liquid.
  • the chambers contain a gas volume, particularly an inert gas such as nitrogen. Since the gas volume is compressible, shocks are better absorbed. The likelihood of the bag bursting, for example, if it falls, is reduced.
  • a gas volume particularly an inert gas such as nitrogen. Since the gas volume is compressible, shocks are better absorbed. The likelihood of the bag bursting, for example, if it falls, is reduced.
  • at least the first, second, and/or third chambers can contain 5-20 ml of gas.
  • the films of the bag are preferably formed as multilayer polyolefin films.
  • the films are particularly formed as multilayer polypropylene films.
  • At least one layer of the film in particular all layers of the film, can be designed as a matrix-phase polymer system.
  • a matrix-phase polymer system at least two different polymers are present, with one polymer being present in a demixed form, in particular as dispersed solidified drops, in the matrix of the other polymer.
  • the matrix polymer of the matrix-phase polymer system of the inner layer, the middle layer, and the outer layer each comprises a polypropylene polymer.
  • the matrix consists of polypropylene.
  • the phase polymer of the matrix-phase polymer system of the inner layer, the middle layer and the outer layer may each comprise at least one styrene-ethylene/butylene-styrene block copolymer (SEBS) as the phase polymer.
  • SEBS styrene-ethylene/butylene-styrene block copolymer
  • SEBS is a block polymer composed of styrene, butylene, and ethylene segments, which includes a hydrogenated butadiene segment followed by styrene groups. This polymer is produced by polymerizing a styrene and butadiene monomer followed by hydrogenation of the previously polymerized SBS. The hydrogenated butadiene forms a soft central block between the styrene blocks.
  • Such a multi-layer system can provide highly transparent and at the same time very tear-resistant films by using other components and/or compositions in the respective layers, which can be easily welded into a bag.
  • the first and/or second peel weld seam is/are designed such that the films of a 30 mm long straight strip separate from each other at a force between 15 and 50 N, preferably between 20 and 30 N.
  • a 30 mm wide cutout is cut out along a straight section of the peel weld seam.
  • the bags are pulled apart on one side of the strip and the maximum force required to separate the strips is measured using a force measuring device.
  • the bag does not comprise an inner bag.
  • no additional, for example, small, bags are arranged or inserted into the chambers of the bag. Each of them is free of an inner bag.
  • the bag comprises exactly three chambers or at least three chambers formed from exactly two films welded together.
  • the bag is designed especially for pediatric applications.
  • the invention further relates to a method for producing a bag filled with a medicinal liquid, comprising the steps:
  • the invention is described by a method for producing a bag filled with a medicinal liquid, comprising the steps:
  • At least a second longitudinal weld seam is welded, wherein the first peel weld seam and/or the second peel weld seam is/are welded after the welding of the lower transverse weld seam and/or after the welding of at least the second longitudinal weld seam.
  • the peel welds are welded after the welding of the longitudinal and transverse welds.
  • the peel welds overlap with the respective longitudinal and transverse welds where the peel weld ends. This ensures that no weakening zone of the respective transverse or longitudinal weld is created in the overlap area. In the overlap area, there is only an imprint of the overlapping peel weld on the transverse or longitudinal weld seam.
  • the chambers of the bag are filled with medicinal liquid via one port each after welding the transverse weld seam and the peel weld seams, especially after welding all weld seams.
  • At least the lower transverse weld seam and the peel weld seams are preferably welded by means of a contact welding process.
  • a welding tool is pressed on, which has a heatable sealing strip that corresponds to the contour of the respective weld seam.
  • the contact time and temperature as well as the pressure of the sealing bar on the weld seam can be used to determine whether it is a peel weld seam or a non-tearable longitudinal or transverse weld seam.
  • the material is less liquefied in peel welds, so they are designed to tear open when pressure is applied to the bag.
  • the bag is rolled up for this purpose.
  • the bag is preferably rolled up from top to bottom. In one embodiment, the bag is rolled up laterally from top right to bottom left.
  • the bag After filling and closing the ports, the bag is preferably packed in secondary packaging and stored in the
  • the secondary packaging can in particular be designed as a tear-open bag, i.e. as a bag with films welded together.
  • the films of the tear-open bag comprise an oxygen barrier layer, in particular a metal or metal oxide layer.
  • Sterilization of the bag packed in the secondary packaging is preferably carried out by autoclaving.
  • Fig. 1 shows an embodiment of a bag according to the invention filled with a medical liquid.
  • Fig. la is a detailed view of a tear zone.
  • Fig. 2 shows the bag arranged in a secondary packaging.
  • Fig. 3 shows another embodiment of a bag filled with a medical liquid.
  • Fig. 4 is a flowchart of an embodiment of the method for manufacturing a medical bag according to the invention. Detailed description of the drawings
  • Fig. 1 shows an exemplary embodiment of a bag 10 filled with a medicinal liquid.
  • the bag 10 is shown in an unfilled state. Information regarding dimensions and the course of the weld seams refers, by definition, to the unfilled bag 10.
  • the bag 10 is formed from two films welded together.
  • the films are welded together via a lower transverse weld seam 11a, an upper transverse weld seam 11b as well as a first longitudinal weld seam 12a, shown here on the right, and a second longitudinal weld seam 12b, shown here on the left.
  • the bag 10 is rectangular.
  • a hanger 13 for attaching or hanging the bag 10 on a rack or stand.
  • the hanger 13 is designed here as an arcuate notch. Furthermore, a cutout is arranged above the hanger 13, which serves as a handle 16 for carrying the bag 10.
  • the bag 10 is divided into a first chamber 16a, a second chamber 16b and a third chamber 16c by a first peel weld seam 14, arranged here on the right, and a second peel weld seam 15, arranged here on the left.
  • the bag 10 is filled with a total of 800 - 1200 ml, preferably 900 - 1100 ml, of a medicinal liquid.
  • the first chamber 16a is preferably filled with a glucose solution.
  • the second chamber 16b is preferably filled with an amino acid-containing solution.
  • the third chamber 16c is preferably filled with a fat emulsion.
  • the first chamber 16a is preferably filled with 550 - 630 ml.
  • the second chamber 16b is preferably filled with 300 - 350 ml.
  • the third chamber 16c is preferably filled with 85 - 130 ml.
  • the second chamber 16b and/or the third chamber 16c has/have a height of 155 - 175 mm (measured between the lower transverse weld seam 11a and the section 14e).
  • the first chamber 16a above the third chamber 16c has a height of 110 - 130 mm (measured between the section 14f and the straight area of the upper transverse weld seam 11b).
  • the first chamber 16a has a width of preferably 50-70 mm (measured between section 14a and the right longitudinal weld seam 12a) in the lower rectilinear section 14a.
  • the second chamber 16b has a width of preferably 145-165 mm (measured between section 14a and section 15a) in the lower rectilinear section 14a/15a.
  • the third chamber 16c has a width of preferably 80-100 mm (measured between section 15a and the left longitudinal weld seam 12b) in the lower rectilinear section 15a.
  • Three ports 20a - 20c are arranged in the lower transverse weld seam 11a.
  • the ports 20a - 20c are each closed with an upper part 23, which is placed on a lower part 21. There is a seal (not shown) between the lower part 21 and the upper part 23.
  • the withdrawal port 20a and the injection port 20b comprise an upper part 23 provided with a break-off cap 24. After breaking off the break-off cap 24, the seal can be pierced with a spike or needle to withdraw liquid from the bag or to dose it into the bag.
  • Port 20c is designed as a blind port and serves only to fill the third chamber 16c. Accordingly, it is closed only by an upper part 23 designed as a cap, with a seal also arranged between the cap and the lower part 21 of port 20c.
  • the ratio of height h to width b of the bag 10 in this embodiment is 0.85 - 1.0.
  • the bag 10 is divided into the three chambers 16a - 16c by a first peel weld seam 14 and a second peel weld seam 15.
  • the first peel weld seam 14 begins at the lower transverse weld seam 11a between the ports 20a and 20b, runs upwards and then to the second longitudinal weld seam 12b.
  • the tear zone A1 is formed by a first curve 14b, which transitions into a second, opposite curve 14c.
  • the curve 14b is narrower than the curve 14c.
  • the first peel weld seam 14 therefore makes an approximately S-shaped offset at the first tear zone Al in the direction of the second peel weld seam 15.
  • the second peel weld seam 15 also comprises a lower straight section 15a, which transitions into an upper straight section 15d via the second curved tear zone A2.
  • the lower straight section 15a and the upper straight section 15d preferably run parallel to the longitudinal weld seams 12a, 12b.
  • the upper straight section 15d runs up to the horizontal straight section 14f of the first peel weld 14.
  • the first tear zone A1 comprises an inflection point W1 and the second tear zone A2 comprises an inflection point W2.
  • the turning point W1 of the first curved tear zone A1 is higher than the turning point W2 of the second tear zone A2.
  • the vertices of the curvatures 14b and 14c of the first peel weld seam 14 are also higher than the respective vertices of the curvatures 15b and 15c of the second peel weld seam 15.
  • the first peel weld seam 14 opens in the area of the curved tear zone A1.
  • the second peel weld seam 15 opens in the area of the second tear-open zone A2.
  • the second peel weld seam 15 opens at least downwards to the lower transverse weld seam 11a, so that the third chamber 16c is then also connected to the remaining bag volume.
  • Fig. 1a is a detailed view of the tear zones A1 and A2.
  • the first curvature 14b/15b and the second curvature 14c/15c each have an inner radius r ⁇ and an outer radius r a .
  • the first bend 14b/15b has an inner radius of 2 to 4 mm and an outer radius of 8 to 12 mm.
  • the second bend 14c/15c has an inner radius of 10 to 16 mm and an outer radius of 15 to 20 mm.
  • the bag shown in Fig. 3 is filled with a total of 1300 - 1700 ml, preferably 1400 - 1600 ml, of liquid.
  • the first chamber 16a is preferably filled with a glucose solution.
  • the second chamber 16b is preferably filled with an amino acid-containing solution.
  • the third chamber 16c is preferably filled with a fat emulsion.
  • the first chamber 16a is preferably filled with 840 - 920 ml.
  • Chamber 16b is preferably filled with 450–525 ml.
  • the third chamber 16c is preferably filled with 140–190 ml.
  • the second chamber 16b and/or the third chamber 16c has/have a height of 210-230 mm (measured between the lower transverse weld seam 11a and the section 14e).
  • the first chamber 16a above the third chamber 16c has a height of 110-140 mm (measured between the section 14f and the straight area of the upper transverse weld seam 11b).
  • the first chamber 16a has a width of preferably 50-70 mm in the lower rectilinear section 14a.
  • the second chamber 16b has a width of preferably 145-165 mm in the lower rectilinear section 14a/15a.
  • the third chamber 16c has a width of preferably 80-100 mm in the lower rectilinear section 15a.
  • the first chamber 16a has a width of preferably 50-70 mm (measured between section 14a and the right longitudinal weld seam 12a) in the lower rectilinear section 14a.
  • the second chamber 16b has a width of preferably 145-165 mm (measured between section 14a and section 15a) in the lower rectilinear section 14a/15a.
  • the third chamber 16c has a width of preferably 80-100 mm (measured between section 15a and the left longitudinal weld seam 12b) in the lower rectilinear section 15a.
  • a 30 mm wide section 40 of the two films is cut out along a straight section of the peel weld seam 14.
  • the films are pulled apart parallel to the peel weld seam 14, and the maximum force required to separate the film strips is measured using a force measuring device. This maximum force corresponds to the tearing force.
  • Fig. 4 is a flowchart of an embodiment of the method 100 according to the invention for producing a medical bag 10.
  • a first and a second film are provided (step 101).
  • the films are preferably formed as multilayer polyolefin films.
  • the films are then welded to the bag 10 by means of a contact welding process, wherein at least one removal port 20a is welded into a lower transverse weld seam 11a (step 102).
  • the bag is then sealed into the three chambers 16a-16c by welding a first peel weld seam 14 and a second peel weld seam 15 (step 103).
  • the peel weld seams 14, 15 are thus made after the longitudinal and transverse weld seams 11a, 11b, 12a, 12b have been welded.
  • the bag is then packaged in a tear-open bag 30, preferably shrink-wrapped (step 104) and autoclaved 105 together with the tear-open bag 30.
  • the invention makes it possible to provide a medical bag which is particularly suitable for pediatric applications.

Landscapes

  • 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)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Hematology (AREA)
  • Bag Frames (AREA)

Abstract

L'invention concerne un sac qui est rempli d'un fluide médical et qui est constitué de deux films qui sont scellés suivant une soudure transversale inférieure, une soudure transversale supérieure, une première soudure longitudinale et une seconde soudure longitudinale. Au moins un orifice d'extraction est disposé dans la soudure transversale inférieure. Le sac est divisé en au moins une première chambre, une deuxième chambre et une troisième chambre par une première soudure pelable et une deuxième soudure pelable. La première soudure pelable présente une première zone de déchirure incurvée, et la deuxième soudure pelable présente une deuxième zone de déchirure incurvée. La première zone de déchirure, à partir de la soudure transversale inférieure, est positionnée plus haut que la deuxième zone de déchirure.
PCT/EP2025/058158 2024-03-25 2025-03-25 Sac rempli d'un fluide médical et son procédé de production Pending WO2025202215A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP24166018.2 2024-03-25
EP24166018 2024-03-25

Publications (1)

Publication Number Publication Date
WO2025202215A1 true WO2025202215A1 (fr) 2025-10-02

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2025/058158 Pending WO2025202215A1 (fr) 2024-03-25 2025-03-25 Sac rempli d'un fluide médical et son procédé de production

Country Status (1)

Country Link
WO (1) WO2025202215A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006010410A1 (fr) 2004-07-29 2006-02-02 Fresenius Kabi Deutschland Gmbh Recipient souple a chambres multiples destine a la preparation de solutions medicales melangees
WO2006010411A1 (fr) * 2004-07-29 2006-02-02 Fresenius Kabi Deutschland Gmbh Recipient medical dote d'une fermeture pelable amelioree
WO2023107945A1 (fr) * 2021-12-07 2023-06-15 Baxter International Inc. Poche à chambres multiples pour solutions de nutrition parentérale
EP4223507A1 (fr) * 2022-02-04 2023-08-09 Fresenius Kabi Deutschland GmbH Emballage secondaire d'un produit médical, ainsi que procédé de fabrication d'un produit médical
WO2023180671A1 (fr) * 2022-03-23 2023-09-28 Technoflex Poche destinée à contenir des substances médicales pour injection intraveineuse

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* Cited by examiner, † Cited by third party
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WO2006010410A1 (fr) 2004-07-29 2006-02-02 Fresenius Kabi Deutschland Gmbh Recipient souple a chambres multiples destine a la preparation de solutions medicales melangees
WO2006010411A1 (fr) * 2004-07-29 2006-02-02 Fresenius Kabi Deutschland Gmbh Recipient medical dote d'une fermeture pelable amelioree
WO2023107945A1 (fr) * 2021-12-07 2023-06-15 Baxter International Inc. Poche à chambres multiples pour solutions de nutrition parentérale
EP4223507A1 (fr) * 2022-02-04 2023-08-09 Fresenius Kabi Deutschland GmbH Emballage secondaire d'un produit médical, ainsi que procédé de fabrication d'un produit médical
WO2023180671A1 (fr) * 2022-03-23 2023-09-28 Technoflex Poche destinée à contenir des substances médicales pour injection intraveineuse

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