EP2193775A1 - Flexible container for medical use - Google Patents
Flexible container for medical use Download PDFInfo
- Publication number
- EP2193775A1 EP2193775A1 EP09178425A EP09178425A EP2193775A1 EP 2193775 A1 EP2193775 A1 EP 2193775A1 EP 09178425 A EP09178425 A EP 09178425A EP 09178425 A EP09178425 A EP 09178425A EP 2193775 A1 EP2193775 A1 EP 2193775A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- container
- internal volume
- portions
- necking
- flexible
- 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.)
- Granted
Links
- 239000012530 fluid Substances 0.000 claims abstract description 21
- 238000000034 method Methods 0.000 claims abstract description 6
- 230000003014 reinforcing effect Effects 0.000 claims abstract 2
- 238000012546 transfer Methods 0.000 claims description 18
- 230000015572 biosynthetic process Effects 0.000 claims description 8
- 239000007788 liquid Substances 0.000 claims description 3
- 239000008155 medical solution Substances 0.000 abstract description 16
- 238000004891 communication Methods 0.000 description 9
- 238000007789 sealing Methods 0.000 description 9
- 208000031968 Cadaver Diseases 0.000 description 8
- 239000000463 material Substances 0.000 description 8
- 230000001954 sterilising effect Effects 0.000 description 7
- 238000004659 sterilization and disinfection Methods 0.000 description 7
- 238000012360 testing method Methods 0.000 description 7
- -1 polypropylene Polymers 0.000 description 6
- 239000004800 polyvinyl chloride Substances 0.000 description 5
- 239000004743 Polypropylene Substances 0.000 description 4
- 238000006073 displacement reaction Methods 0.000 description 4
- 229920001155 polypropylene Polymers 0.000 description 4
- 229920000915 polyvinyl chloride Polymers 0.000 description 4
- 229920000219 Ethylene vinyl alcohol Polymers 0.000 description 3
- 229940082150 encore Drugs 0.000 description 3
- 229920003023 plastic Polymers 0.000 description 3
- 239000004033 plastic Substances 0.000 description 3
- 238000003466 welding Methods 0.000 description 3
- 239000004952 Polyamide Substances 0.000 description 2
- 241001080024 Telles Species 0.000 description 2
- 239000013543 active substance Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000004715 ethylene vinyl alcohol Substances 0.000 description 2
- 229940127554 medical product Drugs 0.000 description 2
- 229920002647 polyamide Polymers 0.000 description 2
- 229920000098 polyolefin Polymers 0.000 description 2
- 241000251556 Chordata Species 0.000 description 1
- 229920012485 Plasticized Polyvinyl chloride Polymers 0.000 description 1
- 229920000297 Rayon Polymers 0.000 description 1
- 240000008042 Zea mays Species 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000005553 drilling Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 239000010408 film Substances 0.000 description 1
- 238000009863 impact test Methods 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000010412 perfusion Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000002964 rayon Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000005728 strengthening Methods 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000010409 thin film Substances 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
Images
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
Definitions
- the present invention relates to a flexible container for medical use. It also relates to a reconstitution assembly comprising such a flexible container, in particular for the administration for medical purposes of a mixture of a liquid contained in this container and of an active agent, for example a powder, contained in a second container such as a bottle.
- a reconstitution assembly comprising such a flexible container, in particular for the administration for medical purposes of a mixture of a liquid contained in this container and of an active agent, for example a powder, contained in a second container such as a bottle.
- Flexible pouches are very widely used in the medical field to contain and deliver medical products.
- these flexible pouches flatten as delivery of their content which allows medical staff to see at a glance the amount of fluid remaining in the flexible bag at any time.
- the Figure 1 shows such a flexible pouch 1 of the prior art.
- This pocket is formed of two flat sheets of plastic material such as polyvinyl chloride (PVC) or polypropylene, which are welded on their periphery 2 to define an internal volume 3 for receiving and containing a medical solution.
- PVC polyvinyl chloride
- polypropylene polypropylene
- This pocket 1 further comprises a port 4 to access the medical solution, this port 4 being located and held in place between the two flat sheets at the lower end of the pocket.
- An orifice 5 in the upper part of the bag 1 makes it possible to suspend the latter on a support member such as a fixing hook.
- the welded lateral edges 6 laterally delimiting the internal volume 3 of the flexible pouch 1 are rectilinear.
- the first is an adhesion of the drops of the medical solution with the inner walls of the bag 1.
- the suction generated during the delivery of the contents of the bag 1 is not sufficient to overcome this adhesion.
- the second is the formation of folds in the pocket 1 envelope, which are cavities in which a fraction of the medical solution is literally trapped.
- the third is the shape of the lower end of the pocket carrying the solution to be delivered to the port 4.
- the zone 7 surrounding the orifice of the port 4 in contact with the medical solution is often more or less horizontally facilitating the retention of part of the medical solution.
- the prescribed amount of the medical solution is not delivered to the patient. This difference between the amount needed and the amount actually delivered to the patient can be serious for one's health.
- the standards for carrying flexible bags such as those provided by the American Society for testing and Materials (ASTM) test, require a low-temperature impact test.
- polypropylene tends to gradually replace PVC in the manufacture of flexible pouches for medical use because of its high inertia vis-à-vis medical solutions.
- the objective of the present invention is therefore to provide a flexible pouch which is simple in its design and in its operating mode, economic and allowing a significant reduction in the formation of folds or even a suppression of the latter, during filling and sterilization of these soft pouches.
- Another object of the present invention is a flexible pouch allowing a good grip for the reconstitution of medication, for example by means of a transfer set.
- the invention relates to a flexible container for medical use comprising at least two superimposed walls and interconnected at least at their periphery, the thus connected walls defining an internal volume for receiving a fluid, an upper portion and a portion. bottom of the container, this internal volume being placed between the upper and lower portions of the container, the container further comprising at least one access element to this internal volume.
- the parts of the walls thus connected which define the internal volume comprise on each of the lateral edges of the container a portion of necking, said necking portions being placed substantially vis-à-vis and directed towards each other to form a tightening of the internal volume.
- the necking portions are further connected to at least one of said upper and lower portions of this container by at least one connecting portion.
- necking portion a portion of the walls thus connected which generates a decrease in the width of the container on a given area thereof and thus creates a tightening of the internal volume.
- the internal volume of the container comprising one or more compartments, the tightening produced by the necking portions placed substantially vis-à-vis, is placed in one of said compartments outside the intersection area of two successive compartments.
- This tightening therefore does not function to delimit two successive compartments but only to reduce or even eliminate the appearance of marked folds.
- said presence of said at least one connecting portion connecting the necking portion to at least one of the upper and lower portions of the flexible container advantageously ensures a minimum capacity to the flexible container. It is indeed necessary that the removal of the marked folds appearing after filling the container by forming the necking portions, does not operate at the expense of the capacity, or filling volume, of the container.
- This capacity is preferably equal to at least 50% of the capacity of the same container without any portion of necking.
- the necking portions are preferably determined so as to remove the creases and to ensure a capacity at least equal to about 280 ml.
- necking portions for which the capacity of the flexible container is close to the initial capacity V of the flexible container without any necking portion.
- the presence of said at least one linking portion implies that the necking portion does not not directly connecting the upper and lower portions of said container on each of the side edges of the container.
- the walls of the container may be connected by welding.
- the shape of the flexible container of the invention is advantageously favorable to its handling and handling.
- the invention also relates to a method of strengthening a flexible container for medical use, to prevent the formation of folds during filling of said container, said flexible container having an internal volume for receiving a liquid.
- At least one necking portion is formed on each of the lateral edges of said container, the necking portions of said lateral edges being placed substantially opposite one another to define a tightening of the internal volume of the container.
- the internal volume of the container comprising one or more compartments, forming the constriction in one of said compartments outside the intersection area of two successive compartments. This tightening therefore does not function to delimit two successive compartments but strengthen the flexible container to reduce or eliminate the appearance of marked folds.
- the internal volume of the container having several compartments, such tightness is formed in each of said compartments.
- this method comprises a first superposition step of at least two sheets, then a step of assembling these sheets at least on their periphery to form the lateral edges, the necking portions and the upper and lower ends.
- said container Prior to assembling the lower end, at least one access member is placed in the internal volume between the at least two sheets.
- the walls of the container can be connected by welding.
- the container comprising upper and lower ends delimiting the internal volume
- the necking portions are connected to at least one of said upper and lower ends by at least one connecting portion.
- This connecting portion may be non-concave. It can thus be linear or substantially linear. It can also be placed vertically or inclined or not.
- these necking portions are concave portions.
- these necking portions have only a rounded shape such as an arcuate shape.
- each necking portion is chosen so that it has a depth p and a height H such that the ratio p / H is in the range] 0, 0.2] and even better understood in the interval [0.05, 0.11] +/- 10%.
- depth means the distance separating the vertex from the portion of concave necking of its base. In the case of a necking having a shape of arc of circle, the depth would be the arrow of this arc of circle while the height H would be the string under tending this arc.
- the invention also relates to a reconstitution assembly comprising a container as described above and a transfer set connected to an access element to the internal volume of this container.
- the second container is a bottle comprising an active substance to be reconstituted.
- the Figure 2 shows a flexible and flexible container according to a particular embodiment of the invention.
- This container 10 comprises at least two sheets of multilayer materials superimposed and welded together at their periphery. As an illustration, it may comprise two welded sheets of multilayer materials comprising at least one polyolefin film conforming to the prescriptions of the pharmacopoeia.
- the upper 12 and lower 13 portions are formed by welding the walls of the container. They are therefore not likely to receive a fluid and are, in this sense, distinct from the internal volume 11. However, they each have a portion in contact with the internal volume 11 delimiting the upper and lower ends of the latter.
- the upper portion 12 comprises at least one hole 14 to ensure the suspension of this container 10 on a support member for the delivery of the medical solution contained in the internal volume 11.
- the lower part 13 of the container comprises a port 15 allowing access to the internal volume 11 of the container.
- This access port 15 is, in known manner, between the thus connected walls of the container 10. It is here placed in the center of the lower portion 13 of the flexible container.
- This access port 15 comprises an upper orifice 16 intended to be placed in contact with the medical solution contained in the internal volume 11 of the container and a lower portion 17 projecting from the container 10 and intended to allow attachment temporarily or definitive of a coupling member of a transfer set or an intravenous line.
- the internal volume 11 is placed between the upper portions 12 and lower 13 of the container.
- the parts of the walls thus connected which define the internal volume 11 comprise on each of the lateral edges of the container 10 a concave portion 18, 18 '. These concave portions 18, 18 'are placed facing each other and directed toward one another to form a tightening of the internal volume 11.
- the ratio of the depth p of each of these concave portions to the height H of these concave portions is equal to 0.1 +/- 10%.
- the portion 20 of the upper portion 12 delimiting the internal volume 11 at its upper end has a concave shape.
- the Figure 3 shows a partial view of a flexible pouch according to another embodiment of the invention.
- the elements of the Figure 3 bearing the same references as the elements of the Figure 2 represent the same objects.
- This flexible pouch was made from a plastic sheath such as plasticized PVC. It comprises at its base two chimneys 21, 22 which are welded between two faces of the sheath when are welded by the upper (not shown) and lower 23 portions of the closure of the pocket.
- These chimneys 21, 22 are tubular sections providing fluid communication between the internal volume 24 for receiving a fluid from the pocket and the outside of the pocket. These chimneys can in known manner be used as "injection site” for one of them and “perfusion site” for the second.
- the Figure 4 shows a partial view of the cavity of a mold element used for producing the lower portion of a flexible container according to a third embodiment of the invention. This lower portion is intended to receive a single access port to the internal volume of the flexible container.
- the portion 25 of the lower portion 26 delimiting the internal volume of the flexible container at its lower end, has a shape of half ellipse.
- This portion 25 of the lower portion 26 delimiting the internal volume at its lower end therefore does not necessarily have rectilinear slopes inclined or not, but may have on the contrary a variable curvature from the lateral edges of the container to the access port to guide and route the fluid contained in the internal volume of the container to this port.
- the filling behavior of a flexible pouch of the state of the art filling volume: 470 ml
- a pouch of the present invention as described in FIG. as described above filling volume: 430 ml
- Unmarked folds are folds that fade after the sterilization step of the flexible pouch and its contents.
- the marked folds are folds that remain after sterilization of the flexible bag and its contents, and which, therefore, are able to generate a weakness of the pocket and thus the appearance of leaks in the "transport" test.
- the flexible container of the present invention aims in particular the removal of marked folds.
- the initial capacity of a container identical in size but not having necking portions is 545 ml.
- the container comprising necking portions having a p / H ratio of 0.07 (circular arc having a radius of curvature of 225 mm) has no pronounced wrinkles and has a capacity optimal of the order of 90% of the volume of the container without any portion of necking.
Landscapes
- Health & Medical Sciences (AREA)
- Hematology (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Bag Frames (AREA)
Abstract
Description
La présente invention concerne un récipient souple à usage médical. Elle concerne également un ensemble de reconstitution comprenant un tel récipient souple, notamment pour l'administration à des fins médicales d'un mélange d'un liquide contenu dans ce récipient et d'un agent actif, par exemple une poudre, contenu dans un second récipient tel qu'un flacon.The present invention relates to a flexible container for medical use. It also relates to a reconstitution assembly comprising such a flexible container, in particular for the administration for medical purposes of a mixture of a liquid contained in this container and of an active agent, for example a powder, contained in a second container such as a bottle.
Les poches souples sont très largement répandues dans le domaine médical pour contenir et délivrer des produits médicaux.Flexible pouches are very widely used in the medical field to contain and deliver medical products.
Ces poches sont notamment avantageuses en ce que leur matériau constitutif est inerte vis-à-vis des produits médicaux qu'elles reçoivent et en ce qu'elles sont très peu perméables à l'air et aux fluides protégeant de ce fait le contenu de la poche.These pockets are particularly advantageous in that their constituent material is inert with respect to the medical products they receive and in that they are very little permeable to air and fluids thereby protecting the contents of the poached.
De plus, ces poches souples s'aplatissent au fur et à mesure de la délivrance de leur contenu ce qui permet au personnel médical de visualiser d'un seul coup d'oeil la quantité de fluide restant dans la poche souple à un instant quelconque.In addition, these flexible pouches flatten as delivery of their content which allows medical staff to see at a glance the amount of fluid remaining in the flexible bag at any time.
La
Cette poche 1 comprend de plus un port 4 pour accéder à la solution médicale, ce port 4 étant situé et maintenu en place entre les deux feuilles plates à l'extrémité inférieure de la poche.This
Un orifice 5 dans la partie supérieure de la poche 1 permet de suspendre celle-ci sur un organe support tel qu'un crochet de fixation.An
Les bords latéraux 6 soudés délimitant latéralement le volume interne 3 de la poche souple 1 sont rectilignes.The welded
Toutefois, on peut observer, après délivrance du contenu de la poche souple 1, un "piégeage" d'une fraction plus ou moins importante de la solution médicale dans la poche souple 1.However, it can be observed, after delivery of the contents of the
Cette perte de solution médicale a plusieurs origines.This loss of medical solution has several origins.
La première est une adhérence des gouttes de la solution médicale avec les parois internes de la poche 1. L'aspiration générée lors de la délivrance du contenu de la poche 1 n'est pas suffisante pour surmonter cette adhérence.The first is an adhesion of the drops of the medical solution with the inner walls of the
La deuxième est la formation de plis dans l'enveloppe de la poche 1, lesquels constituent des cavités dans lesquelles une fraction de la solution médicale est littéralement piégée.The second is the formation of folds in the
Ces plis apparaissent lors du remplissage de la poche souple 1 avec la solution médicale et leur formation est encore accentuée lors de l'étape de stérilisation de la poche en raison du ramollissement des matériaux en température.These folds appear during the filling of the
La troisième tient à la forme de l'extrémité inférieure de la poche acheminant la solution à délivrer vers le port 4. A titre illustratif, la zone 7 entourant l'orifice du port 4 en contact avec la solution médicale, est souvent plus ou moins horizontale facilitant la retenue d'une partie de la solution médicale.The third is the shape of the lower end of the pocket carrying the solution to be delivered to the
Il en résulte que la quantité prescrite de la solution médicale n'est pas délivrée au patient. Cette différence entre la quantité nécessaire et celle réellement délivrée au patient peut s'avérer grave pour sa santé.As a result, the prescribed amount of the medical solution is not delivered to the patient. This difference between the amount needed and the amount actually delivered to the patient can be serious for one's health.
D'autre part, les normes de transport des poches souples, telles que celles prévues par le test ASTM (American Society for testing and Materials), imposent un test de résistance aux chocs à basse température.On the other hand, the standards for carrying flexible bags, such as those provided by the American Society for testing and Materials (ASTM) test, require a low-temperature impact test.
Si ces tests ne représentent pas un problème particulier pour les poches souples en PVC, ils sont critiques pour des poches réalisées dans d'autres matériaux tels que le polypropylène.While these tests are not a particular problem for flexible PVC bags, they are critical for pockets made of other materials such as polypropylene.
On observe en effet l'apparition de fuites, après test, souvent dans les zones de la poche où des plis se sont formés lors du remplissage de cette dernière, ces plis ayant été encore accentués par la stérilisation à la vapeur.Indeed, the appearance of leaks, after testing, often occurs in areas of the pocket where folds have formed during the filling of the latter, these folds having been further accentuated by steam sterilization.
Par ailleurs, ces tests sont d'autant plus critiques que la masse de la poche, et donc son volume, est importante.Moreover, these tests are all the more critical as the mass of the pocket, and therefore its volume, is important.
Or, le polypropylène tend à remplacer progressivement le PVC dans la fabrication des poches souples à usage médical en raison de sa grande inertie vis-à-vis des solutions médicales.However, polypropylene tends to gradually replace PVC in the manufacture of flexible pouches for medical use because of its high inertia vis-à-vis medical solutions.
Il en résulte que ce test "de transport" des poches souples devient critique et peut engendrer des causes de rejet ou de réclamation.As a result, this "transport" test of the flexible pouches becomes critical and can cause rejection or claim causes.
Par ailleurs, il est connu de l'art antérieur d'utiliser des poches souples ayant un volume interne bien supérieur au volume de fluide à stocker afin d'éviter la formation de plis lors du remplissage de ces poches et de leur stérilisation.Furthermore, it is known from the prior art to use flexible bags having an internal volume much greater than the volume of fluid to be stored in order to prevent the formation of folds during the filling of these bags and their sterilization.
Toutefois, un tel mode de remplissage va à l'encontre des intérêts économiques des fabricants de poche souple puisque la quantité de matière plastique nécessaire pour recevoir un volume de fluide donné n'est pas optimisée.However, such a method of filling goes against the economic interests of flexible pouch manufacturers since the amount of plastic material needed to receive a given volume of fluid is not optimized.
Il serait donc intéressant de disposer d'une poche souple dont le volume interne corresponde au volume de fluide à stocker, sans les pertes de fluide constatées avec les poches de l'art antérieur.It would therefore be advantageous to have a flexible pouch whose internal volume corresponds to the volume of fluid to be stored, without the losses of fluid found with the pockets of the prior art.
L'objectif de la présente invention est donc de proposer une poche souple qui soit simple dans sa conception et dans son mode opératoire, économique et permettant une réduction significative de la formation des plis, voire une suppression de ces derniers, lors du remplissage et de la stérilisation de ces poches souples.The objective of the present invention is therefore to provide a flexible pouch which is simple in its design and in its operating mode, economic and allowing a significant reduction in the formation of folds or even a suppression of the latter, during filling and sterilization of these soft pouches.
Un autre objet de la présente invention est une poche souple autorisant une bonne prise en main pour la reconstitution de médicament, par exemple au moyen d'un set de transfert.Another object of the present invention is a flexible pouch allowing a good grip for the reconstitution of medication, for example by means of a transfer set.
A cet effet, l'invention concerne un récipient souple pour usage médical comprenant au moins deux parois superposées et reliées entre elles au moins à leur périphérie, les parois ainsi reliées définissant un volume interne destiné à recevoir un fluide, une portion supérieure et une portion inférieure du récipient, ce volume interne étant placé entre les portions supérieure et inférieure de ce récipient, le récipient comportant de plus au moins un élément d'accès à ce volume interne.For this purpose, the invention relates to a flexible container for medical use comprising at least two superimposed walls and interconnected at least at their periphery, the thus connected walls defining an internal volume for receiving a fluid, an upper portion and a portion. bottom of the container, this internal volume being placed between the upper and lower portions of the container, the container further comprising at least one access element to this internal volume.
Selon l'invention, les parties des parois ainsi reliées qui définissent le volume interne comportent sur chacun des bords latéraux du récipient une portion de striction, ces portions de striction étant placées sensiblement en vis-à-vis et dirigées l'une vers l'autre pour former un resserrement du volume interne. Les portions de striction sont de plus reliées à au moins une desdites portions supérieure et inférieure de ce récipient par au moins une portion de liaison.According to the invention, the parts of the walls thus connected which define the internal volume comprise on each of the lateral edges of the container a portion of necking, said necking portions being placed substantially vis-à-vis and directed towards each other to form a tightening of the internal volume. The necking portions are further connected to at least one of said upper and lower portions of this container by at least one connecting portion.
On entend par "portion de striction", une portion des parois ainsi reliées qui génère une diminution de la largeur du récipient sur une zone déterminée de celui-ci et donc crée un resserrement du volume interne.The term "necking portion", a portion of the walls thus connected which generates a decrease in the width of the container on a given area thereof and thus creates a tightening of the internal volume.
On entend par "ces portions de striction sont placées sensiblement en vis-à-vis" que ces portions de striction sont placées en vis-à-vis ou à peu près en vis-à-vis, par exemple à +/-10% en hauteur.The term "these necking portions are placed substantially vis-à-vis" that these necking portions are placed vis-à-vis or approximately vis-à-vis, for example at +/- 10% in height.
Le volume interne du récipient comprenant un ou plusieurs compartiments, le resserrement produit par les portions de striction placées sensiblement en vis-à-vis, est placé dans un desdits compartiments en dehors de la zone d'intersection de deux compartiments successifs. Ce resserrement n'a donc pas pour fonction de délimiter deux compartiments successifs mais seulement de réduire voire supprimer l'apparition de plis marqués.The internal volume of the container comprising one or more compartments, the tightening produced by the necking portions placed substantially vis-à-vis, is placed in one of said compartments outside the intersection area of two successive compartments. This tightening therefore does not function to delimit two successive compartments but only to reduce or even eliminate the appearance of marked folds.
La présence de ladite au moins une portion de liaison reliant la portion de striction à l'une au moins des portions supérieure et inférieure du récipient souple permet avantageusement de garantir une contenance minimale au récipient souple. Il est, en effet, nécessaire que la suppression des plis marqués apparaissant après remplissage du récipient par la formation des portions de striction, ne s'opère pas au détriment de la contenance, ou volume de remplissage, du récipient. Cette contenance est, de préférence, égale à au moins 50% de la contenance du même récipient sans aucune portion de striction.
Ainsi, pour un récipient souple d'une contenance Vinitial de 545 ml ne présentant pas de portion de striction, les portions de striction sont avantageusement déterminées de manière à supprimer les plis marqués et à assurer une contenance au moins égale à environ 280 ml.
Bien entendu, on cherchera de préférence des portions de striction pour lesquelles la contenance du récipient souple est proche de la contenance Vinitial du récipient souple sans aucune portion de striction. La présence de ladite au moins une portion de liaison implique que la portion de striction ne relie pas directement les portions supérieure et inférieure dudit récipient sur chacun des bords latéraux de ce récipient.The presence of said at least one connecting portion connecting the necking portion to at least one of the upper and lower portions of the flexible container advantageously ensures a minimum capacity to the flexible container. It is indeed necessary that the removal of the marked folds appearing after filling the container by forming the necking portions, does not operate at the expense of the capacity, or filling volume, of the container. This capacity is preferably equal to at least 50% of the capacity of the same container without any portion of necking.
Thus, for a flexible container of a V initial capacity of 545 ml having no necking portion, the necking portions are preferably determined so as to remove the creases and to ensure a capacity at least equal to about 280 ml.
Of course, it will preferably seek necking portions for which the capacity of the flexible container is close to the initial capacity V of the flexible container without any necking portion. The presence of said at least one linking portion implies that the necking portion does not not directly connecting the upper and lower portions of said container on each of the side edges of the container.
A titre purement illustratif, les parois du récipient peuvent être reliées par soudure.For purely illustrative purposes, the walls of the container may be connected by welding.
On observe que la forme du récipient souple de l'invention est avantageusement favorable à sa prise en main et à sa manipulation.It is observed that the shape of the flexible container of the invention is advantageously favorable to its handling and handling.
Dans différents modes de réalisation particuliers de ce récipient souple, chacun ayant ses avantages particuliers et susceptibles de nombreuses combinaisons techniques possibles:
- les portions de striction sont des portions concaves,
Avantageusement, mais non obligatoirement, ces portions concaves sont placées de manière à former un resserrement situé de manière sensiblement centrale au volume interne.
De préférence, ces portions de striction présentent uniquement une forme arrondie telle qu'une forme d'arc de cercle. - chacune de ces portions de striction a une profondeur p et une hauteur H telle que le rapport p/H est compris dans l'intervalle ]0, 0,2] et encore mieux compris dans l'intervalle [0,05 , 0,11] +/- 10%,
On entend par "profondeur", la distance séparant le sommet de la portion de striction concave de sa base. Dans le cas d'une striction ayant une forme d'arc de cercle, la profondeur serait la flèche de cet arc de cercle tandis que la hauteur H serait la corde sous tendant cet arc.
Le rapport p/H est mesuré pour la portion de striction concave uniquement. Bien entendu, le nombre zéro est exclu de cet intervalle.
On évite avec un tel intervalle de valeurs pour le rapport p/H de générer un "effet de pointe" susceptible d'induire la formation de pliure, par exemple une pliure reliant directement les portions de striction entre elles. Cet "effet de pointe" conduirait désavantageusement au résultat inverse recherché.
Cet intervalle de valeurs pour le rapport p/H permet également de garantir une contenance optimale de la poche en raison de la présence d'au moins une portion de liaison. - les portions de liaison sont des portions non concaves,
Ces portions non concaves peuvent être linéaires ou sensiblement linéaires. Elles peuvent ainsi être placées verticalement ou de manière inclinée.
Alternativement, ces portions non concaves peuvent encore être des portions bombées vers l'extérieur du volume interne. Par exemple, ces portions peuvent être arrondies vers l'extérieur. - la portion supérieure comporte au moins un trou pour suspendre le récipient,
- la portion supérieure délimitant le volume interne à son extrémité supérieure, la partie de ladite portion supérieure en contact avec le volume interne a une forme concave,
Alternativement, cette partie de la portion supérieure en contact avec le volume interne a une forme convexe. - la portion inférieure délimitant le volume interne à son extrémité inférieure, la partie de ladite portion inférieure en contact avec ledit volume interne a une forme en V pour éviter le piégeage d'une fraction dudit fluide destiné à être reçu dans ledit volume interne, les branches dudit V formant un angle compris entre 45° et 85° par rapport à un plan vertical passant par la pointe dudit V,
De préférence, cet angle est compris entre 60° et 70°. - les parois sont réalisées en polypropylène, polyoléfine, polyamide, en PVC plastifié ou souple, copolymère éthylène-alcool vinylique (EVOH), dépôt d'oxyde en couche mince ou encore en une combinaison d'au moins deux de ces éléments,
- le volume interne de ce récipient peut comporter un ou plusieurs compartiments,
Lorsque le volume interne du récipient souple comporte deux compartiments par exemple, le compartiment supérieur et le compartiment inférieur qui est en communication de fluide avec l'élément d'accès au volume interne du récipient comprennent chacun des portions de striction afin de permettre une délivrance de l'ensemble du contenu de ces compartiments.
Les compartiments sont alors séparés par un joint tel qu'une soudure pelable pour permettre la mise en communication de fluide des deux compartiments. - les parois comportent de plus sur au moins une partie de leur surface externe une couche bloquant ou absorbant les rayons UV,
- l'extrémité de la partie de l'élément d'accès placée dans la portion inférieure a une forme évasée.
Cette forme évasée permet avantageusement de guider le fluide contenu dans le volume interne du récipient vers l'extrémité de l'élément d'accès placée à l'extérieur du récipient souple.
Les pentes de cette forme évasée forment, de préférence, un prolongement de la partie de la portion inférieure délimitant le volume interne du récipient souple à son extrémité inférieure.
- the necking portions are concave portions,
Advantageously, but not necessarily, these concave portions are placed so as to form a tightening located substantially centrally to the internal volume.
Preferably, these necking portions have only a rounded shape such as an arcuate shape. - each of these necking portions has a depth p and a height H such that the ratio p / H is in the range] 0, 0.2] and even more preferably in the range [0.05, 0.11 ] +/- 10%,
The term "depth" means the distance separating the vertex from the portion of concave necking of its base. In the case of a necking having a shape of arc of circle, the depth would be the arrow of this arc of circle while the height H would be the string under tending this arc.
The ratio p / H is measured for the portion of concave necking only. Of course, the number zero is excluded from this interval.
With such a range of values for the ratio p / H, it is avoided to generate a "peak effect" capable of inducing fold formation, for example a fold directly connecting the necking portions to one another. This "peak effect" would disadvantageously lead to the opposite result sought.
This range of values for the ratio p / H also makes it possible to guarantee an optimal capacity of the pocket because of the presence of at least one connecting portion. - the connecting portions are non-concave portions,
These non-concave portions may be linear or substantially linear. They can thus be placed vertically or inclined.
Alternatively, these non-concave portions may still be curved portions towards the outside of the internal volume. For example, these portions may be rounded outward. - the upper portion has at least one hole for suspending the container,
- the upper portion delimiting the internal volume at its upper end, the portion of said upper portion in contact with the internal volume has a concave shape,
Alternatively, that portion of the upper portion in contact with the internal volume has a convex shape. - the lower portion defining the internal volume at its lower end, the portion of said lower portion in contact with said internal volume has a V-shaped shape to avoid trapping a fraction of said fluid intended to be received in said internal volume, the branches said V forming an angle between 45 ° and 85 ° with respect to a vertical plane passing through the tip of said V,
Preferably, this angle is between 60 ° and 70 °. - the walls are made of polypropylene, polyolefin, polyamide, plasticized or flexible PVC, ethylene-vinyl alcohol copolymer (EVOH), thin film oxide or a combination of at least two of these elements,
- the internal volume of this container may comprise one or more compartments,
When the internal volume of the flexible container has two compartments for example, the upper compartment and the lower compartment which is in fluid communication with the access element to the internal volume of the container each comprise necking portions to allow a delivery of the entire contents of these compartments.
The compartments are then separated by a seal such as a peelable weld to allow fluid communication of the two compartments. - the walls further include on at least a portion of their outer surface a layer blocking or absorbing UV rays,
- the end of the portion of the access member in the lower portion has a flared shape.
This flared shape advantageously allows the fluid contained in the internal volume of the container to be guided towards the end of the access element placed outside the flexible container.
The slopes of this flared shape preferably form an extension of the portion of the lower portion delimiting the internal volume of the flexible container at its lower end.
L'invention concerne également un procédé de renforcement d'un récipient souple pour usage médical, pour prévenir la formation de plis lors du remplissage dudit récipient, ledit récipient souple ayant un volume interne destiné à recevoir un liquide.The invention also relates to a method of strengthening a flexible container for medical use, to prevent the formation of folds during filling of said container, said flexible container having an internal volume for receiving a liquid.
Selon l'invention, on forme sur chacun des bords latéraux dudit récipient au moins une portion de striction, les portions de striction desdits bords latéraux étant placées sensiblement en vis-à-vis pour définir un resserrement du volume interne du récipient.According to the invention, at least one necking portion is formed on each of the lateral edges of said container, the necking portions of said lateral edges being placed substantially opposite one another to define a tightening of the internal volume of the container.
Le volume interne du récipient comprenant un ou plusieurs compartiments, on forme le resserrement dans un desdits compartiments en dehors de la zone d'intersection de deux compartiments successifs.
Ce resserrement n'a donc pas pour fonction de délimiter deux compartiments successifs mais de renforcer le récipient souple afin de réduire voire supprimer l'apparition de plis marqués.The internal volume of the container comprising one or more compartments, forming the constriction in one of said compartments outside the intersection area of two successive compartments.
This tightening therefore does not function to delimit two successive compartments but strengthen the flexible container to reduce or eliminate the appearance of marked folds.
Le volume interne du récipient comportant plusieurs compartiments, on forme un tel resserrement dans chacun desdits compartiments.The internal volume of the container having several compartments, such tightness is formed in each of said compartments.
A titre purement illustratif, ce procédé comporte une première étape de superposition d'au moins deux feuilles, puis une étape d'assemblage de ces feuilles au moins sur leur périphérie pour former les bords latéraux, les portions de striction et les extrémités supérieure et inférieure dudit récipient. Préalablement à l'assemblage de l'extrémité inférieure, on place au moins un élément d'accès au volume interne entre lesdites au moins deux feuilles. On peut relier, par exemple, les parois du récipient par soudure.For purely illustrative purposes, this method comprises a first superposition step of at least two sheets, then a step of assembling these sheets at least on their periphery to form the lateral edges, the necking portions and the upper and lower ends. said container. Prior to assembling the lower end, at least one access member is placed in the internal volume between the at least two sheets. For example, the walls of the container can be connected by welding.
Avantageusement, le récipient comprenant des extrémités supérieure et inférieure délimitant le volume interne, les portions de striction sont reliées à au moins l'une desdites extrémités supérieure et inférieure par au moins une portion de liaison. Cette portion de liaison peut être non concave. Elle peut ainsi être linéaire ou sensiblement linéaire. Elle peut de plus être placée verticalement ou de manière inclinée ou non.Advantageously, the container comprising upper and lower ends delimiting the internal volume, the necking portions are connected to at least one of said upper and lower ends by at least one connecting portion. This connecting portion may be non-concave. It can thus be linear or substantially linear. It can also be placed vertically or inclined or not.
Avantageusement, ces portions de striction sont des portions concaves. De préférence, ces portions de striction présentent uniquement une forme arrondie telle qu'une forme d'arc de cercle.Advantageously, these necking portions are concave portions. Preferably, these necking portions have only a rounded shape such as an arcuate shape.
De préférence, on choisit chaque portion de striction de sorte qu'elle présente une profondeur p et une hauteur H telle que le rapport p/H est compris dans l'intervalle ]0, 0,2] et encore mieux compris dans l'intervalle [0,05 , 0,11] +/- 10%.
On entend par "profondeur", la distance séparant le sommet de la portion de striction concave de sa base. Dans le cas d'une striction ayant une forme d'arc de cercle, la profondeur serait la flèche de cet arc de cercle tandis que la hauteur H serait la corde sous tendant cet arc.Preferably, each necking portion is chosen so that it has a depth p and a height H such that the ratio p / H is in the range] 0, 0.2] and even better understood in the interval [0.05, 0.11] +/- 10%.
The term "depth" means the distance separating the vertex from the portion of concave necking of its base. In the case of a necking having a shape of arc of circle, the depth would be the arrow of this arc of circle while the height H would be the string under tending this arc.
L'invention concerne encore un ensemble de reconstitution comportant un récipient tel que décrit précédemment et un set de transfert relié à un élément d'accès au volume interne de ce récipient.The invention also relates to a reconstitution assembly comprising a container as described above and a transfer set connected to an access element to the internal volume of this container.
Un tel set de transfert a, par exemple, été décrit par la présente demandeuse dans la demande de brevet
- un premier corps de transfert comprenant une première extrémité et une deuxième extrémité, cette première extrémité étant destinée à être reliée au récipient souple tel que décrit précédemment, ce premier corps de transfert comprenant un premier conduit central logeant une première extrémité au moins d'un perforateur mobile, cette première extrémité comprenant un élément de perçage, un premier élément d'étanchéité étant destiné à empêcher la communication de fluide entre le récipient souple et ce premier corps de transfert, cette première extrémité étant destinée à être placée dans le conduit central en retrait de l'élément d'étanchéité de sorte que ce premier élément d'étanchéité est non percé dans une position inactivée de ce set de transfert,
- un deuxième corps de transfert comprenant une première extrémité et une deuxième extrémité, la première extrémité ayant un élément d'attache pour recevoir et fixer un deuxième récipient, le deuxième récipient étant fermé par un deuxième élément d'étanchéité, le deuxième corps de transfert comprenant un deuxième conduit central logeant la deuxième extrémité au moins de ce perforateur mobile, cette extrémité comprenant un élément de perçage, les premier et deuxième conduits centraux étant coaxiaux, le deuxième conduit central débouchant dans l'élément d'attache pour permettre le passage de la deuxième extrémité vers le deuxième élément d'étanchéité, la deuxième extrémité étant destinée à être placée dans le deuxième conduit en retrait du deuxième élément d'étanchéité de sorte que le deuxième élément d'étanchéité est non percé dans une position inactivée du set de transfert,
- au moins une partie du deuxième corps de transfert étant déplaçable le long d'un axe de déplacement d'une position inactivée du set de transfert où ladite partie du deuxième corps de transfert est partiellement insérée dans la deuxième extrémité du premier corps de transfert à une position activée du set de transfert où une communication de fluide entre le récipient souple et le deuxième récipient est établie,
- des moyens d'entraînement coopérant avec le perforateur mobile pour déplacer ce perforateur au moins en rotation le long de l'axe de déplacement lors du déplacement de ladite partie de la position inactivée à la position activée,
- ce perforateur étant destiné à percer d'abord l'élément d'étanchéité fermant le second récipient puis l'élément d'étanchéité du récipient souple lors de son déplacement.
- a first transfer body comprising a first end and a second end, this first end being intended to be connected to the flexible container as described above, this first transfer body comprising a first central duct housing a first end of at least one perforator mobile, this first end comprising a piercing element, a first sealing element being intended to prevent the communication of fluid between the flexible container and the first transfer body, this first end being intended to be placed in the central conduit recessed of the sealing element so that this first sealing element is not pierced in an inactivated position of this transfer set,
- a second transfer body including a first end and a second end, the first end having an attachment member for receiving and securing a second container, the second container being closed by a second sealing member, the second transfer body comprising a second central duct housing the second end at least of this mobile perforator, this end comprising an element of drilling, the first and second central ducts being coaxial, the second central duct opening into the fastener element to allow the passage of the second end towards the second sealing element, the second end being intended to be placed in the second led back from the second sealing element so that the second sealing element is not pierced in an inactivated position of the transfer set,
- at least a part of the second transfer body being displaceable along an axis of displacement of an inactivated position of the transfer set where said part of the second transfer body is partially inserted into the second end of the first transfer body at a activated position of the transfer set where fluid communication between the flexible container and the second container is established,
- driving means cooperating with the mobile perforator to move this perforator at least in rotation along the axis of displacement during the displacement of said part of the inactivated position to the activated position,
- this perforator being intended to pierce first the sealing element closing the second container and then the sealing element of the flexible container during its displacement.
Avantageusement, le deuxième récipient est un flacon comprenant une substance active à reconstituer.Advantageously, the second container is a bottle comprising an active substance to be reconstituted.
L'invention sera décrite plus en détail en référence aux dessins annexés dans lesquels:
- la
figure 1 montre de manière schématique une poche souple de l'art antérieur; - la
figure 2 représente schématiquement un récipient souple selon un premier mode de réalisation de l'invention; - la
Figure 3 montre une vue partielle d'un récipient souple selon un deuxième mode de réalisation de l'invention ; - la
Figure 4 montre une vue partielle de l'empreinte d'un élément de moule servant à la réalisation de la portion inférieure d'un récipient souple selon un troisième mode de réalisation de l'invention ;
- the
figure 1 shows schematically a flexible pouch of the prior art; - the
figure 2 schematically represents a flexible container according to a first embodiment of the invention; - the
Figure 3 shows a partial view of a flexible container according to a second embodiment of the invention; - the
Figure 4 shows a partial view of the cavity of a mold element used for producing the lower portion of a flexible container according to a third embodiment of the invention;
La
Ce récipient 10 comporte au moins deux feuilles de matériaux multicouches superposées et soudées entre elles à leur périphérie. A titre illustratif, il peut comporter deux feuilles soudées de matériaux multicouches comprenant au moins un film de polyoléfines conforme aux prescriptions de la pharmacopée.This
Ces feuilles ainsi reliées définissent un volume interne 11 destiné à recevoir un fluide, la solution médicale, une portion supérieure 12 et une portion inférieure 13 de ce récipient.These sheets thus connected define an
Les portions supérieure 12 et inférieure 13 sont formées par la soudure des parois du récipient. Elles ne sont donc pas susceptibles de recevoir un fluide et sont, en ce sens, distinctes du volume interne 11. Elles ont toutefois chacune une partie en contact avec le volume interne 11 délimitant les extrémités supérieure et inférieure de ce dernier.The upper 12 and lower 13 portions are formed by welding the walls of the container. They are therefore not likely to receive a fluid and are, in this sense, distinct from the
La portion supérieure 12 comporte au moins un trou 14 pour assurer la suspension de ce récipient 10 sur un organe support en vue de la délivrance de la solution médicale contenue dans le volume interne 11.The
La partie inférieure 13 du récipient comprend un port 15 permettant l'accès au volume interne 11 du récipient. Ce port d'accès 15 est, de manière connue, pris entre les parois ainsi reliées du récipient 10. Il est ici placé au centre de la portion inférieure 13 du récipient souple. Ce port d'accès 15 comporte un orifice supérieur 16 destiné à être placé en contact avec la solution médicale contenue dans le volume interne 11 du récipient et une partie inférieure 17 formant saillie du récipient 10 et destinée à permettre l'attachement de manière temporaire ou définitive d'un organe de couplage d'un set de transfert ou d'une ligne intraveineuse.The
Le volume interne 11 est placé entre les portions supérieure 12 et inférieure 13 du récipient.The
Les parties des parois ainsi reliées qui définissent le volume interne 11 comportent sur chacun des bords latéraux du récipient 10 une portion concave 18, 18'. Ces portions concaves 18, 18' sont placées en vis-à-vis et dirigées l'une vers l'autre pour former un resserrement du volume interne 11.The parts of the walls thus connected which define the
Ces portions concaves 18, 18' sont reliées aux portions supérieure 12 et inférieure 13 du récipient par une portion de liaison 19, 19' qui est ici linéaire et verticale.These
Le rapport de la profondeur p de chacune de ces portions concave sur la hauteur H de ces portions concaves est égal à 0,1 +/- 10%.The ratio of the depth p of each of these concave portions to the height H of these concave portions is equal to 0.1 +/- 10%.
La partie 20 de la portion supérieure 12 délimitant le volume interne 11 à son extrémité supérieure a une forme concave.The
La
Cette poche souple a été confectionnée à partir d'une gaine en matière plastique telle que le PVC plastifié. Elle comporte à sa base deux cheminées 21, 22 qui sont soudées entre deux faces de la gaine lorsque sont réalisés par soudure les portions supérieure (non représentée) et inférieure 23 de fermeture de la poche.This flexible pouch was made from a plastic sheath such as plasticized PVC. It comprises at its base two
Ces cheminées 21, 22 sont des tronçons tubulaires assurant la communication de fluide entre le volume interne 24 destiné à recevoir un fluide de la poche et l'extérieur de la poche. Ces cheminées peuvent de manière connue être mises en oeuvre en tant que "site d'injection" pour l'une d'entre elles et "site de perfusion" pour la seconde.These
La
La partie 25 de la portion inférieure 26 délimitant le volume interne du récipient souple à son extrémité inférieure, a une forme de demie ellipse.The
Cette partie 25 de la portion inférieure 26 délimitant le volume interne à son extrémité inférieure ne présente donc pas nécessairement des pentes rectilignes inclinées ou non, mais peut présenter bien au contraire une courbure variable en allant des bords latéraux du récipient vers le port d'accès afin de guider et acheminer le fluide contenu dans le volume interne du récipient vers ce port.This
Dans un mode de mise en oeuvre de la présente invention, on a comparé le comportement au remplissage d'une poche souple de l'état de l'art (volume de remplissage: 470 ml) et d'une poche de la présente invention telle que décrite ci-dessus (volume de remplissage: 430 ml).In one embodiment of the present invention, the filling behavior of a flexible pouch of the state of the art (filling volume: 470 ml) and a pouch of the present invention as described in FIG. as described above (filling volume: 430 ml).
Après remplissage de ces poches, on peut observer la présence de nombreux plis sur la poche souple de l'état de l'art, notamment sur les bords latéraux de cette poche. Ces plis sont encore accentués après stérilisation en autoclave de la poche souple ainsi remplie. La poche souple de la présente invention ne présente pas ces plis.After filling these pockets, one can observe the presence of many folds on the flexible bag of the state of the art, especially on the side edges of this pocket. These folds are further accentuated after autoclave sterilization of the flexible pouch thus filled. The flexible pouch of the present invention does not have these folds.
Avec les poches souples de l'art antérieur, on distinguera l'apparition de deux types de plis après remplissage de la poche souple avec la solution médicale. Des plis dits "marqués", c'est-à-dire prononcés, voire très prononcés, et des plis secondaires dits "non marqués".With the soft bags of the prior art, there will be distinguished the appearance of two types of folds after filling the flexible bag with the medical solution. Folds called "marked", that is to say, pronounced or very pronounced, and secondary folds called "unmarked".
Les plis non marqués sont des plis qui s'atténuent après l'étape de stérilisation de la poche souple et de son contenu.Unmarked folds are folds that fade after the sterilization step of the flexible pouch and its contents.
Les plis marqués sont des plis qui restent après stérilisation de la poche souple et de son contenu, et qui, par conséquent, sont aptes à générer une faiblesse de la poche et donc l'apparition de fuites au test de "transport".The marked folds are folds that remain after sterilization of the flexible bag and its contents, and which, therefore, are able to generate a weakness of the pocket and thus the appearance of leaks in the "transport" test.
Le récipient souple de la présente invention vise notamment la suppression des plis marqués.The flexible container of the present invention aims in particular the removal of marked folds.
On décrira par la suite un autre mode de mise en oeuvre de la présente invention pour un récipient souple ayant une hauteur H entre les portions supérieure et inférieure de 183 mm.
(en mm)
(en mm)
(en mm)
(en ml)
(in mm)
(in mm)
(in mm)
(in ml)
La contenance initiale d'un récipient identique dans ses dimensions mais ne présentant pas de portions de striction, est de 545 ml.The initial capacity of a container identical in size but not having necking portions is 545 ml.
Il ressort clairement à la lecture du tableau I que le récipient comprenant des portions de striction ayant un rapport p/H de 0,07 (arc de cercle ayant un rayon de courbure de 225 mm) ne présente pas de plis marqués et a une contenance optimale de l'ordre de 90% du volume du récipient sans aucune portion de striction.It is clear from the reading of Table I that the container comprising necking portions having a p / H ratio of 0.07 (circular arc having a radius of curvature of 225 mm) has no pronounced wrinkles and has a capacity optimal of the order of 90% of the volume of the container without any portion of necking.
Claims (12)
caractérisé en ce que les parties des parois ainsi reliées qui définissent ledit volume interne (11) comportent sur chacun des bords latéraux dudit récipient une portion de striction (18, 18'), lesdites portions de striction (18, 18') étant placées sensiblement en vis-à-vis et dirigées l'une vers l'autre pour former un resserrement dudit volume interne (11),
characterized in that the parts of the walls thus connected which define said internal volume (11) comprise on each of the lateral edges of said container a necking portion (18, 18 '), said necking portions (18, 18') being placed substantially facing each other and directed toward each other to form a tightening of said internal volume (11),
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0858332A FR2939308B1 (en) | 2008-12-08 | 2008-12-08 | FLEXIBLE CONTAINER FOR MEDICAL USE |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2193775A1 true EP2193775A1 (en) | 2010-06-09 |
EP2193775B1 EP2193775B1 (en) | 2012-02-22 |
Family
ID=40875195
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP09178425A Active EP2193775B1 (en) | 2008-12-08 | 2009-12-08 | Flexible container for medical use |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP2193775B1 (en) |
AT (1) | ATE546125T1 (en) |
FR (1) | FR2939308B1 (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2014033228A1 (en) | 2012-08-31 | 2014-03-06 | Flexiways Sprl | Flexible container for transporting products such as biocides |
CN104434516A (en) * | 2013-09-24 | 2015-03-25 | 张政 | Matte-surface anti-skid transfusion bag conveniently held by human hands |
WO2015146759A1 (en) * | 2014-03-27 | 2015-10-01 | テルモ株式会社 | Medical container |
WO2017140824A1 (en) * | 2016-02-17 | 2017-08-24 | Sandoz Ag | Package, use thereof, method for manufacturing same, and kit comprising said package |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005131221A (en) | 2003-10-31 | 2005-05-26 | Fuso Pharmaceutical Industries Ltd | Film bag |
WO2008003045A2 (en) | 2006-06-28 | 2008-01-03 | Hospira, Inc. | Medical fluid container |
EP1949883A1 (en) | 2007-01-24 | 2008-07-30 | Technoflex | Method and set for transferring a fluid between two containers |
WO2009081671A1 (en) | 2007-12-25 | 2009-07-02 | Jms Co., Ltd. | Medical container and medical container set |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3911918A (en) * | 1972-04-13 | 1975-10-14 | Ralph D Turner | Blood collection, storage and administering bag |
US4432763A (en) * | 1982-05-10 | 1984-02-21 | The Kendall Company | Fluid delivery system and method |
DE3531430A1 (en) * | 1985-09-03 | 1987-03-05 | Biotest Pharma Gmbh | METHOD FOR OBTAINING COMPONENTS FROM A LIQUID WITH COMPONENTS PRESENT IN AREAS SEPARATELY SEPARATED |
DE4016144A1 (en) * | 1990-05-18 | 1991-11-21 | Fresenius Ag | Container for enteral feeding of patient - has two parts connected by duct which can be closed by clip |
US5984912A (en) * | 1997-07-25 | 1999-11-16 | Brocco Diagnostics, Inc. | Collapsible medical bag for the containment and delivery of diagnostic contrast media and parenteral drug formulations |
FR2859625B1 (en) * | 2003-09-11 | 2006-05-05 | Christiane Cinqualbre | FLEXIBLE CONTAINER FOR EXTERNAL PREPARATION AND ADMINISTRATION OF A LIQUID PRODUCT, IN PARTICULAR A MEDICAMENT SOLUTE |
-
2008
- 2008-12-08 FR FR0858332A patent/FR2939308B1/en active Active
-
2009
- 2009-12-08 EP EP09178425A patent/EP2193775B1/en active Active
- 2009-12-08 AT AT09178425T patent/ATE546125T1/en active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005131221A (en) | 2003-10-31 | 2005-05-26 | Fuso Pharmaceutical Industries Ltd | Film bag |
WO2008003045A2 (en) | 2006-06-28 | 2008-01-03 | Hospira, Inc. | Medical fluid container |
EP1949883A1 (en) | 2007-01-24 | 2008-07-30 | Technoflex | Method and set for transferring a fluid between two containers |
WO2009081671A1 (en) | 2007-12-25 | 2009-07-02 | Jms Co., Ltd. | Medical container and medical container set |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2014033228A1 (en) | 2012-08-31 | 2014-03-06 | Flexiways Sprl | Flexible container for transporting products such as biocides |
CN104434516A (en) * | 2013-09-24 | 2015-03-25 | 张政 | Matte-surface anti-skid transfusion bag conveniently held by human hands |
WO2015146759A1 (en) * | 2014-03-27 | 2015-10-01 | テルモ株式会社 | Medical container |
JPWO2015146759A1 (en) * | 2014-03-27 | 2017-04-13 | テルモ株式会社 | Medical container |
WO2017140824A1 (en) * | 2016-02-17 | 2017-08-24 | Sandoz Ag | Package, use thereof, method for manufacturing same, and kit comprising said package |
Also Published As
Publication number | Publication date |
---|---|
FR2939308B1 (en) | 2012-04-06 |
FR2939308A1 (en) | 2010-06-11 |
EP2193775B1 (en) | 2012-02-22 |
ATE546125T1 (en) | 2012-03-15 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
EP2645981B1 (en) | Bag for distributing a product for biopharmaceutical use in the general state of a liquid or paste via a plurality of outlet ports | |
EP1012227B1 (en) | Flexible bags for transporting biopharmaceutical fluid products | |
EP2193775B1 (en) | Flexible container for medical use | |
CA2841030C (en) | Kit for preserving a biological product including a three-dimensional bag and a matching three-dimensional casing | |
WO2003094999A1 (en) | Packaging for the transport of sterile objects or objects to be sterilised | |
FR2965556A1 (en) | DETECTION OF THE INTEGRITY OF A FLEXIBLE, CLOSED, PLASTIC-LOCKED POCKET FOR RECEIVING AND PROTECTING A BIOPHARMACEUTICAL PRODUCT OR DEVICE | |
EP1799174B9 (en) | Storage assembly for contrast media | |
EP2542474A1 (en) | Method for manufacturing sterile flexible bags filled with a product, particularly with a therapeutic liquid, and corresponding bags | |
FR3027220A1 (en) | ASSEMBLY FOR STORING MEDICAL USE PRODUCTS | |
EP1757542B1 (en) | Package for transporting objects in a pneumatic conveyer system | |
EP2999450B1 (en) | Stopper of a connector for an infusion bag | |
WO2014096643A1 (en) | Infusion system for administering a solution and rinsing of said system | |
CA2470224A1 (en) | Administration tip for a flexible bag for medical use | |
FR2948284A1 (en) | Infusion device for flexible medical usage container during cancer treatment of patient, has lips spaced from one another by having constriction increasing from divisible stopper towards sealing element, and conduit receiving infusion set | |
EP2907649B1 (en) | Method for manufacturing at least one flexible plastic container | |
EP2560692B9 (en) | Sterilizable biopharmaceutical packaging | |
EP2999449A1 (en) | Base for a connector for an infusion bag | |
WO2023180671A1 (en) | Pouch intended to contain medical substances for intravenous injection | |
FR2954694A1 (en) | PROCESS FOR MANUFACTURING A FLEXIBLE CONTAINER FOR MEDICAL USE | |
WO1993013738A1 (en) | Pierce-opening bag |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO SE SI SK SM TR |
|
AX | Request for extension of the european patent |
Extension state: AL BA RS |
|
17P | Request for examination filed |
Effective date: 20101105 |
|
17Q | First examination report despatched |
Effective date: 20101208 |
|
GRAP | Despatch of communication of intention to grant a patent |
Free format text: ORIGINAL CODE: EPIDOSNIGR1 |
|
GRAS | Grant fee paid |
Free format text: ORIGINAL CODE: EPIDOSNIGR3 |
|
GRAA | (expected) grant |
Free format text: ORIGINAL CODE: 0009210 |
|
AK | Designated contracting states |
Kind code of ref document: B1 Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO SE SI SK SM TR |
|
REG | Reference to a national code |
Ref country code: GB Ref legal event code: FG4D Free format text: NOT ENGLISH |
|
REG | Reference to a national code |
Ref country code: CH Ref legal event code: EP |
|
REG | Reference to a national code |
Ref country code: AT Ref legal event code: REF Ref document number: 546125 Country of ref document: AT Kind code of ref document: T Effective date: 20120315 |
|
REG | Reference to a national code |
Ref country code: IE Ref legal event code: FG4D Free format text: LANGUAGE OF EP DOCUMENT: FRENCH |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R096 Ref document number: 602009005454 Country of ref document: DE Effective date: 20120412 |
|
REG | Reference to a national code |
Ref country code: NL Ref legal event code: T3 |
|
LTIE | Lt: invalidation of european patent or patent extension |
Effective date: 20120222 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: HR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 Ref country code: IS Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120622 Ref country code: NO Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120522 Ref country code: LT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 |
|
REG | Reference to a national code |
Ref country code: CH Ref legal event code: NV Representative=s name: MICHELI & CIE SA |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: GR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120523 Ref country code: FI Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 Ref country code: PT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120622 Ref country code: LV Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 |
|
REG | Reference to a national code |
Ref country code: IE Ref legal event code: FD4D |
|
REG | Reference to a national code |
Ref country code: AT Ref legal event code: MK05 Ref document number: 546125 Country of ref document: AT Kind code of ref document: T Effective date: 20120222 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: CY Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: RO Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 Ref country code: DK Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 Ref country code: CZ Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 Ref country code: SE Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 Ref country code: SI Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 Ref country code: IE Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 Ref country code: PL Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 Ref country code: EE Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: SK Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 |
|
PLBE | No opposition filed within time limit |
Free format text: ORIGINAL CODE: 0009261 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT |
|
26N | No opposition filed |
Effective date: 20121123 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: AT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R097 Ref document number: 602009005454 Country of ref document: DE Effective date: 20121123 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: ES Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120602 |
|
BERE | Be: lapsed |
Owner name: TECHNOFLEX Effective date: 20121231 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: MC Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20121231 Ref country code: BG Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120522 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: BE Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20121231 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: MT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: TR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: SM Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 Ref country code: LU Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20121208 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: HU Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20091208 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: MK Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120222 |
|
REG | Reference to a national code |
Ref country code: FR Ref legal event code: PLFP Year of fee payment: 7 |
|
REG | Reference to a national code |
Ref country code: FR Ref legal event code: PLFP Year of fee payment: 8 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: IT Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20151208 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: IT Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20151208 |
|
PGRI | Patent reinstated in contracting state [announced from national office to epo] |
Ref country code: IT Effective date: 20170710 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: IT Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20161208 |
|
PGRI | Patent reinstated in contracting state [announced from national office to epo] |
Ref country code: IT Effective date: 20170710 |
|
REG | Reference to a national code |
Ref country code: FR Ref legal event code: PLFP Year of fee payment: 9 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: IT Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20161208 |
|
PGRI | Patent reinstated in contracting state [announced from national office to epo] |
Ref country code: IT Effective date: 20190710 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: NL Payment date: 20231124 Year of fee payment: 15 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: GB Payment date: 20231220 Year of fee payment: 15 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: IT Payment date: 20231212 Year of fee payment: 15 Ref country code: FR Payment date: 20231114 Year of fee payment: 15 Ref country code: DE Payment date: 20231208 Year of fee payment: 15 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: CH Payment date: 20240101 Year of fee payment: 15 |