EP2193775A1 - Flexibler Behälter für den medizinischen Einsatz - Google Patents

Flexibler Behälter für den medizinischen Einsatz Download PDF

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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
Application number
EP09178425A
Other languages
English (en)
French (fr)
Other versions
EP2193775B1 (de
Inventor
François CAPITAINE
Nicolas Chato
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Technoflex SA
Original Assignee
Technoflex SA
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Filing date
Publication date
Application filed by Technoflex SA filed Critical Technoflex SA
Publication of EP2193775A1 publication Critical patent/EP2193775A1/de
Application granted granted Critical
Publication of EP2193775B1 publication Critical patent/EP2193775B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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)
EP09178425A 2008-12-08 2009-12-08 Flexibler Behälter für den medizinischen Einsatz Active EP2193775B1 (de)

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 true EP2193775A1 (de) 2010-06-09
EP2193775B1 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)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014033228A1 (fr) 2012-08-31 2014-03-06 Flexiways Sprl Récipient 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

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005131221A (ja) 2003-10-31 2005-05-26 Fuso Pharmaceutical Industries Ltd フィルムバッグ
WO2008003045A2 (en) 2006-06-28 2008-01-03 Hospira, Inc. Medical fluid container
EP1949883A1 (de) 2007-01-24 2008-07-30 Technoflex Flüssigkeitsumfüllungsverfahren und -set zwischen zwei Behältern
WO2009081671A1 (ja) 2007-12-25 2009-07-02 Jms Co., Ltd. 医療用容器及び医療用容器セット

Family Cites Families (6)

* Cited by examiner, † Cited by third party
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

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005131221A (ja) 2003-10-31 2005-05-26 Fuso Pharmaceutical Industries Ltd フィルムバッグ
WO2008003045A2 (en) 2006-06-28 2008-01-03 Hospira, Inc. Medical fluid container
EP1949883A1 (de) 2007-01-24 2008-07-30 Technoflex Flüssigkeitsumfüllungsverfahren und -set zwischen zwei Behältern
WO2009081671A1 (ja) 2007-12-25 2009-07-02 Jms Co., Ltd. 医療用容器及び医療用容器セット

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014033228A1 (fr) 2012-08-31 2014-03-06 Flexiways Sprl Récipient 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
JPWO2015146759A1 (ja) * 2014-03-27 2017-04-13 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

Also Published As

Publication number Publication date
FR2939308B1 (fr) 2012-04-06
EP2193775B1 (de) 2012-02-22
ATE546125T1 (de) 2012-03-15
FR2939308A1 (fr) 2010-06-11

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