EP2193775B1 - Flexibler Behälter für den medizinischen Einsatz - Google Patents
Flexibler Behälter für den medizinischen Einsatz Download PDFInfo
- Publication number
- EP2193775B1 EP2193775B1 EP09178425A EP09178425A EP2193775B1 EP 2193775 B1 EP2193775 B1 EP 2193775B1 EP 09178425 A EP09178425 A EP 09178425A EP 09178425 A EP09178425 A EP 09178425A EP 2193775 B1 EP2193775 B1 EP 2193775B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- container
- portions
- inner volume
- container according
- internal volume
- 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.)
- Active
Links
- 239000012530 fluid Substances 0.000 claims abstract description 21
- 238000012546 transfer Methods 0.000 claims description 18
- 230000008602 contraction Effects 0.000 claims 1
- 239000008155 medical solution Substances 0.000 abstract description 16
- 238000000034 method Methods 0.000 abstract description 4
- 230000003014 reinforcing effect Effects 0.000 abstract 1
- 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
- 230000015572 biosynthetic process Effects 0.000 description 7
- 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
- 239000007788 liquid 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 as claimed relates to a flexible container for medical use comprising at least two superimposed walls and interconnected at least at their periphery, the walls thus connected defining an internal volume for receiving a fluid, an upper portion and a lower portion of the container, this internal volume being placed between the upper and lower portions of this 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.
- 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 with an initial capacity of 545 ml V having no portion of necking, the necking portions are advantageously determined so as to remove the marked folds and to ensure a capacity of at least 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)
Claims (10)
- Weiches Gefäß für medizinische Zwecke, umfassend zumindest zwei überlagerte und zumindest an ihrer Peripherie miteinander verbundene Wandungen, wobei die besagten und derart verbundenen Wandungen ein Innenvolumen (11) definieren, das dazu bestimmt ist, eine Flüssigkeit aufzunehmen, sowie einen oberen Abschnitt (12) und einen unteren Abschnitt (13) des besagten Gefäßes, wobei das besagte Innenvolumen (11) zwischen dem besagten oberen Abschnitt (12) und dem besagten unteren Abschnitt (13) des besagten Gefäßes angeordnet ist, und das besagte Gefäß des Weiteren zumindest ein Element für den Zugriff (15) auf das besagte Innenvolumen (11) umfasst, und die derart verbundenen Wandungsabschnitte, die das besagte Innenvolumen (11) definieren, an jedem der seitlichen Ränder des besagten Gefäßes einen eingeschnürten Abschnitt (18, 18') umfassen, und die besagten eingeschnürten Abschnitte (18, 18') in etwa einander gegenüber angeordnet und zueinander ausgerichtet sind, um eine Verengung des besagten Innenvolumens (11) zu bilden, und die besagten eingeschnürten Abschnitte (18, 18') durch zumindest einen Verbindungsabschnitt (19, 19') mit zumindest einem der besagten oberen (12) und unteren Abschnitte (13) des besagten Gefäßes verbunden sind, und
dadurch gekennzeichnet, dass jeder der besagten eingeschnürten Abschnitte (18, 18') ein konkaver Abschnitt ist und eine Tiefe p und eine Höhe H in der Art aufweist, dass das Verhältnis p/H in einem Intervall von [0, 0,2] enthalten ist. - Gefäß nach Anspruch 1, dadurch gekennzeichnet, dass das besagte Verhältnis p/H zwischen 0.05 und 0.11 +/- 10% liegt.
- Gefäß nach irgendeinem der Ansprüche 1 bis 2, dadurch gekennzeichnet, dass die besagten Verbindungsabschnitte (19, 19') keine konkaven Abschnitte sind.
- Gefäß nach Anspruch 3, dadurch gekennzeichnet, dass die besagten nicht konkaven Abschnitte linear oder in etwa linear sind.
- Gefäß nach irgendeinem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass der besagte obere Abschnitt das Innenvolumen (11) an seinem oberen Ende abgrenzt, und der Teil des oberen Abschnitts, der das besagte Innenvolumen (11) berührt, eine konkave oder konvexe Form aufweist.
- Gefäß nach irgendeinem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass der besagte untere Abschnitt das Innenvolumen (11) an seinem unteren Ende abgrenzt, und der Teil des unteren Abschnitts (13), der das besagte Innenvolumen (11) berührt, eine V-Form aufweist, um den Einschluss eines Bruchteiles der besagten Flüssigkeit zu vermeiden, die dazu bestimmt ist, im besagten Innenvolumen (11) aufgenommen zu werden, wobei die Schenkel des besagten V einen Winkel zwischen 45° und 85° in Bezug auf eine senkrechte Ebene einschlagen, die durch die Spitze des besagten V verläuft.
- Gefäß nach Anspruch 6, dadurch gekennzeichnet, dass der besagte Winkel zwischen 60° und 70° liegt.
- Gefäß nach irgendeinem der Ansprüche 1 bis 7, dadurch gekennzeichnet, dass das Ende des Abschnitts des besagten Zugriffselements (15), das im besagten unteren Abschnitt (13) angeordnet ist, eine aufgeweitete Form aufweist.
- Gefäß nach irgendeinem der Ansprüche 1 bis 8, dadurch gekennzeichnet, dass das Innenvolumen des besagten Gefäßes ein oder mehrere Fächer umfasst.
- Rekonstitutionseinheit umfassend ein Gefäß nach irgendeinem der Ansprüche 1 bis 9 und ein Transfer-Set, das mit einem Element für den Zugriff (15) auf das besagte Innenvolumen (11) des besagten Gefäßes verbunden ist.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0858332A FR2939308B1 (fr) | 2008-12-08 | 2008-12-08 | Recipient souple a usage medical |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2193775A1 EP2193775A1 (de) | 2010-06-09 |
EP2193775B1 true EP2193775B1 (de) | 2012-02-22 |
Family
ID=40875195
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP09178425A Active EP2193775B1 (de) | 2008-12-08 | 2009-12-08 | Flexibler Behälter für den medizinischen Einsatz |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP2193775B1 (de) |
AT (1) | ATE546125T1 (de) |
FR (1) | FR2939308B1 (de) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BE1020869A3 (fr) | 2012-08-31 | 2014-06-03 | Flexiways Sprl | Recipient souple pour le transport de produits tels que des biocides. |
CN104434516A (zh) * | 2013-09-24 | 2015-03-25 | 张政 | 一种便于人手拿握的磨砂表面防滑输液袋 |
WO2015146759A1 (ja) * | 2014-03-27 | 2015-10-01 | テルモ株式会社 | 医療用容器 |
WO2017140824A1 (de) * | 2016-02-17 | 2017-08-24 | Sandoz Ag | Gebinde, dessen verwendung, verfahren zu dessen herstellung und das gebinde umfassendes kit |
Family Cites Families (10)
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 (de) * | 1985-09-03 | 1987-03-05 | Biotest Pharma Gmbh | Verfahren zur gewinnung von komponenten aus einer fluessigkeit mit in raeumlich getrennten bereichen vorliegenden komponenten |
DE4016144A1 (de) * | 1990-05-18 | 1991-11-21 | Fresenius Ag | Behaelter zur enteralen ernaehrung |
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 (fr) * | 2003-09-11 | 2006-05-05 | Christiane Cinqualbre | Contenant souple pour la preparation extemporanee et l'administration d'un produit liquide notamment un solute a usage de medicament |
JP4387761B2 (ja) | 2003-10-31 | 2009-12-24 | 扶桑薬品工業株式会社 | フィルムバッグ |
EP2037830A4 (de) | 2006-06-28 | 2013-11-06 | Hospira Inc | Behälter für medizinische flüssigkeit |
FR2911493B1 (fr) * | 2007-01-24 | 2009-03-13 | Technoflex Sa | Procede et set de transfert d'un fluide entre deux recipients. |
JP5116459B2 (ja) | 2007-12-25 | 2013-01-09 | 株式会社ジェイ・エム・エス | 医療用容器及び医療用容器セット |
-
2008
- 2008-12-08 FR FR0858332A patent/FR2939308B1/fr active Active
-
2009
- 2009-12-08 EP EP09178425A patent/EP2193775B1/de active Active
- 2009-12-08 AT AT09178425T patent/ATE546125T1/de active
Also Published As
Publication number | Publication date |
---|---|
FR2939308B1 (fr) | 2012-04-06 |
EP2193775A1 (de) | 2010-06-09 |
ATE546125T1 (de) | 2012-03-15 |
FR2939308A1 (fr) | 2010-06-11 |
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