EP3541344A1 - Medizinischer beutel mit zwei kammern und mit einer lasche - Google Patents

Medizinischer beutel mit zwei kammern und mit einer lasche

Info

Publication number
EP3541344A1
EP3541344A1 EP17804246.1A EP17804246A EP3541344A1 EP 3541344 A1 EP3541344 A1 EP 3541344A1 EP 17804246 A EP17804246 A EP 17804246A EP 3541344 A1 EP3541344 A1 EP 3541344A1
Authority
EP
European Patent Office
Prior art keywords
pocket
compartments
weld
labels
medical use
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
EP17804246.1A
Other languages
English (en)
French (fr)
Other versions
EP3541344B1 (de
EP3541344C0 (de
Inventor
Fabien Pruvot
Emmanuel ARNAULT
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
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Technoflex SA filed Critical Technoflex SA
Publication of EP3541344A1 publication Critical patent/EP3541344A1/de
Application granted granted Critical
Publication of EP3541344B1 publication Critical patent/EP3541344B1/de
Publication of EP3541344C0 publication Critical patent/EP3541344C0/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2024—Separating means having peelable seals
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3261—Flexible containers having several compartments
    • B65D81/3266—Flexible containers having several compartments separated by a common rupturable seal, a clip or other removable fastening device
    • 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
    • A61J2205/00—General identification or selection means
    • A61J2205/30—Printed labels

Definitions

  • the present invention relates to the field of pouches for medical use.
  • the present invention more particularly relates to a medical pocket with two compartments comprising a tongue.
  • pouches for medical use comprising two compartments.
  • one of the two compartments is filled with a liquid (diluent) and the other compartment contains a powder (medicine).
  • the prior art discloses, by US Pat. No. 6,468,377 B1, a flexible container for storing and administering medical solutions.
  • the container comprises a transparent front sheet consisting of a flat layer of a polymer and an opposing backsheet.
  • the backsheet consists of a flat laminated layer.
  • the front and back leaves are sealed together along a common peripheral edge to form a volume enclosure.
  • the volume chamber is made of materials having oxygen and moisture barrier properties that allow the thermoplastic material of the container to be stored for extended periods of time without degrading the contents.
  • the volume chamber is then inflated with a pressurized gas to permanently stretch the front and back sheets and outward to thereby increase the volume capacity of the container.
  • An alternative embodiment of the container includes multiple compartments, separated by removable seals, to contain a diluent and a drug.
  • the seals are broken by the handling of the container for thus mixing the contents at the same time for administration to a patient via a type IV arrangement.
  • Lateral tubes are provided to fill the bag, as shown in Figure 6 of this US patent of the state of the art.
  • FIG. 6 shows a connector / tube for filling the liquid and a connector / tube for filling the powder. This filling compartment is then removed / cut and then welded to obtain the finished product, as shown in Figures 1 and 2 of this prior art US patent.
  • the present invention intends to overcome the disadvantages of the prior art by providing a pocket for medical use with two compartments for easier filling.
  • the present invention relates, in its most general sense, to a pocket for medical use comprising at least two compartments, a peelable weld between the compartments, a permanent weld on the contour of said pocket and at least one filling tube , further comprising an opening having no weld on one of the compartments.
  • This opening does not have solder on one of the compartments, hereinafter referred to as "tongue" makes filling easier. Indeed, during filling, a specific opening system, for example suction cups, is positioned on the pocket to separate the front portion of the rear portion and allow the insertion of a filling spout. This opening system requires the most flexible films possible, hence the interest of not placing aluminum in this area.
  • the compartment having said opening is intended to receive a powder.
  • said pocket has two labels located on the compartment intended to receive a powder, a label being located on the rear face and the other label being located on the front face of said pocket.
  • said pocket is manufactured from two transparent films before the deposition of said labels.
  • the use of a transparent film in direct contact with the powder and the liquid makes it possible to have a better respect of the regulatory standards, insofar as it is about a more inert and less contaminating material.
  • the complex containing aluminum, present in the labels is not in direct contact with the solution, unlike the pockets of the prior art.
  • said pocket implements a complex / overpack to condition said filled bag. This makes it possible to increase the service life and to protect the bag from external contaminations.
  • the other compartment is intended to receive a liquid and said pocket is transparent in the portion of the pocket that receives said liquid, and is also transparent in the portion of the pocket that receives said powder when said labels are removed.
  • said pocket is able to be folded and to be kept folded thanks to the overpack. This protects the peelable weld.
  • said liquid is located on the bottom of the pocket. In case of use without rupture of the peelable solder, it is therefore the liquid alone, which is a solvent, for example a salt-water salt, which will be administered to the patient without risk.
  • said pocket comprises means so that, during the breaking of said peelable weld, the entire width of said peelable weld does not yield under pressure.
  • This causes a liquid jet jet often located in the middle of the peelable weld. The jet generates a vortex that facilitates the homogenization of the powder in the solution.
  • At least one of the labels is welded to said bag, and, during the process of sealing the tag on said bag, the tag is held by a suction device, the bag then being positioned and the welding done.
  • This hold by depression allows a robust and repeatable process when soldering the label on the pocket.
  • At least one of the labels is welded to said bag after filling said bag. This allows a control of filling ("visual inspection" in English terminology) by the entity that fills the pocket before the application of labels.
  • At least one of the two labels is peelable, that is to say it is able to withdraw before the use of said pocket.
  • These labels have an identical level of adhesion, whatever the temperature used during the welding process, since a peelable film is used in the inner layer of this label.
  • said opening has no horizontal weld on one of the compartments.
  • said opening has no vertical weld on one of the compartments.
  • said pocket has two compartments.
  • Figure 1 illustrates the pouch according to the present invention, in one embodiment
  • Figure 2 shows the pouch according to the present invention, with two labels welded on the upper part, in one embodiment
  • Figure 3 illustrates a compartment of the pouch according to the present invention after filling, in one embodiment.
  • the present invention relates to a pocket 10 for medical use comprising at least two compartments 1 1, 12, a weld 13 peelable between the compartments 1 1, 12, a permanent weld 14 on the contour of said pocket 10 and at least one tube 15 filling, further comprising an opening 16 having no weld on one of the two compartments 1 1, 12.
  • said opening 16 does not have a horizontal weld on one of the compartments 11, 12.
  • said opening 16 has no vertical weld on one of the compartments 11, 12.
  • said pocket has two compartments
  • Figure 1 illustrates the pouch 10 according to the present invention, in one embodiment. It can be observed in FIG. 1 that the bag 10 according to the present invention comprises two compartments 11 and 12, a peelable weld 13 enabling a rupture under pressure, a permanent weld 14 on the contour of said pocket 10 and a filling tube 15. It can also be seen in FIG. 1 that the pocket 10 according to the present invention comprises an opening 16 which does not have a horizontal weld on the compartment 11.
  • the pouch 10 according to the present invention has permanent welds, peel welds (weak solder to be broken during the end use) and also an opening called tab which does not have a horizontal weld.
  • the pouch 10 according to the present invention has a filling tube and a "tongue" on the top of the pouch allowing an opening of the pouch over its entire width; this will also allow the filling of the pocket with one of the components.
  • the compartment 12 of the bag 10 according to the present invention comprising a tube 15 is filled through this tube 15 according to a standard method, the compartment 1 1 comprising the tongue is filled by spreading the two films and then integrating a mouthpiece. filling in the pocket.
  • the filling spout is extended so that a welding tool at least comes to achieve a weld on the upper part of the pocket and on the maximum of the entire width thereof.
  • the pocket 10 according to the present invention comprises an open zone that does not represent the entire width of the pocket 10.
  • the pouch 10 according to the present invention also has labels, one on the back and another on the front of the pocket. These labels are located on the compartment that will receive the powder (a compound sensitive to water vapor, light and oxygen and therefore requires the presence of an aluminum barrier).
  • Figure 2 shows the pouch according to the present invention, with two labels welded on the upper part, in one embodiment.
  • Figure 2 shows the aluminum label, a welded area of the label, and welds on three sides for maintaining the label on the front pocket. If it is positioned before filling, the label is welded on at most three sides simply because the pocket 10 according to the present invention does not have areas that can receive a weld before filling the powder on the upper part. Indeed, if the fourth welding of the label was carried out, by heat transfer, a weld inside the compartment (between the two transparent films) would also be present and block the filling. On the other hand, if the label (s) are deposited after filling, one can imagine that during the deposit of these labels, the four welds will be performed at the same time.
  • Figure 3 illustrates a pocket compartment according to the present invention after filling, in one embodiment.
  • the filler will have to develop a machine allowing this opening.
  • a system of suction pads applied to the tongue may be adapted to open the compartment. This film overrun is not just for filling. It also makes it possible to increase the size of the powder compartment to reduce the rise of powder at the level of the weld zone. This dust is indeed a contaminating and troublesome element for achieving a reliable weld.
  • Said tongue also makes it possible to weld the top of the pocket and to make the suspension hole. After welding the top of the pocket with a fairly wide weld, a part can be perforated to act as a hanging hole (hole that allows to hang the pocket in hospitals).
  • the opening 16 does not have a horizontal or vertical weld on one of the compartments 1 1, 12, also called “tab”, constitutes a film / bag overflow above the label (at least on empty bag). If one wishes pockets without labels and place them after filling, this overrun will be present but not identifiable as an overrun compared to the labels but rather as a longer pocket length.
  • This overrun can be visible before or after filling, because the labels themselves can be put before and after filling.
  • This overflow is welded only on both sides but not horizontally, and is flexible enough to allow easy opening.
  • This tongue will be made of a material compatible with pharmaceutical products to ensure compatibility with the component placed in the pocket, and is welded after filling.
  • a suspension hole is made in this tongue.
  • this tongue is covered by aluminum labels in the case where the removal of the labels is done after filling.
  • the dimensions, and the height in particular, of this tongue will be defined so as to avoid residues in this area after filling.
  • the transparent film used for this tab is a film compatible with pharmaceutical products, for example of INERTA type 108, and can be welded to allow storage of solution.
  • this film is also "peelable" to make peelable welds.
  • the bag 10 according to the present invention comprises a filling tube at said tongue to facilitate the filling of the powder.
  • the compartment 1 1 having said opening 16 is intended to receive a powder.
  • the pocket 10 comprises two labels located on the compartment 1 1 intended to receive a powder, a label being located on the rear face and the other label being located on the front face of said pocket. 10.
  • the pouch 10 according to the present invention is made from two transparent films before the deposition of said labels. In one embodiment, the pouch 10 according to the present invention implements a complex / overpack to condition said filled pouch.
  • the other compartment 12 is intended to receive a liquid and said pocket is transparent in the portion of the pocket
  • the pocket 10 which receives said liquid, and is also transparent in the portion of the bag 10 which receives said powder when said labels are removed.
  • the pocket 10 according to the present invention is able to be folded and to be kept folded thanks to the overwrap.
  • said liquid is located on the bottom of the pocket.
  • the pocket 10 according to the present invention comprises means so that, during the breaking of said peelable weld 13, the entire width of said peelable weld 13 does not yield under pressure.
  • At least one of the labels is welded to said bag 10, and during the process of sealing the tag on said bag 10, the tag is held by a suction device, the bag being then positioned and the weld performed.
  • At least one of the labels is welded to said bag 10 after filling said bag 10.
  • at least one of the two tags is peelable, that is to say it is able to withdraw before the use of said pocket 10.
  • the label (s) reinforces (s) the peelable weld separating the components (the force / pressure necessary to open this peelable is greater with the label or labels than without). This reinforces the protection of this peelable solder which must not yield before the removal of the labels and its use.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Bag Frames (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP17804246.1A 2016-11-16 2017-11-13 Medizinischer beutel mit zwei kammern und mit einer lasche Active EP3541344B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1661075A FR3058638B1 (fr) 2016-11-16 2016-11-16 Poche a usage medical a deux compartiments comportant une languette
PCT/FR2017/053088 WO2018091809A1 (fr) 2016-11-16 2017-11-13 Poche à usage médical à deux compartiments comportant une languette

Publications (3)

Publication Number Publication Date
EP3541344A1 true EP3541344A1 (de) 2019-09-25
EP3541344B1 EP3541344B1 (de) 2023-10-25
EP3541344C0 EP3541344C0 (de) 2023-10-25

Family

ID=58347509

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17804246.1A Active EP3541344B1 (de) 2016-11-16 2017-11-13 Medizinischer beutel mit zwei kammern und mit einer lasche

Country Status (13)

Country Link
US (1) US20200060934A1 (de)
EP (1) EP3541344B1 (de)
JP (1) JP2020503914A (de)
KR (1) KR20190099404A (de)
CN (1) CN110402132A (de)
AU (1) AU2017361942A1 (de)
BR (1) BR112019009948A2 (de)
CA (1) CA3044015A1 (de)
CO (1) CO2019006267A2 (de)
ES (1) ES2967414T3 (de)
FR (1) FR3058638B1 (de)
MX (1) MX2019005708A (de)
WO (1) WO2018091809A1 (de)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3133745A1 (fr) 2022-03-23 2023-09-29 Technoflex P oche destinée à contenir des substances médicales pour injection intraveineuse

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS63309263A (ja) * 1987-06-09 1988-12-16 Otsuka Pharmaceut Factory Inc 輸液バッグ
US5176634A (en) * 1990-08-02 1993-01-05 Mcgaw, Inc. Flexible multiple compartment drug container
JP3079403B2 (ja) * 1992-05-03 2000-08-21 株式会社大塚製薬工場 複室容器
TW294632B (de) * 1993-02-05 1997-01-01 Otsuka Pharma Factory Inc
SE9601348D0 (sv) * 1996-04-10 1996-04-10 Pharmacia Ab Improved containers for parenteral fluids
US5944709A (en) 1996-05-13 1999-08-31 B. Braun Medical, Inc. Flexible, multiple-compartment drug container and method of making and using same
JP3002430B2 (ja) * 1997-01-20 2000-01-24 株式会社ファースト・システム・サービス 血液製剤管理票および血液製剤管理システム
PL196513B1 (pl) * 1998-07-08 2008-01-31 Flexipol Packaging Ltd Torba
JP4476435B2 (ja) * 1999-07-22 2010-06-09 株式会社細川洋行 仕切部材、複室輸液容器および薬剤入り複室輸液容器の製造方法
US7678097B1 (en) * 1999-11-12 2010-03-16 Baxter International Inc. Containers and methods for manufacturing same
US7243787B2 (en) * 2003-03-26 2007-07-17 Nipro Corporation Medicine bag
DE602004028861D1 (de) * 2003-12-02 2010-10-07 Fuso Pharmaceutical Ind Doppelkammer-behälter
CN2822617Y (zh) * 2005-05-13 2006-10-04 湖南千山制药机械股份有限公司 装液体和固体药的输液用单口管串联多室袋
JP3118911U (ja) * 2005-11-29 2006-02-09 株式会社大塚製薬工場 複室バッグ
CN201002812Y (zh) * 2007-01-18 2008-01-09 孔亚丽 一种碘酒棉签包装袋
JP3131605U (ja) * 2007-02-23 2007-05-17 株式会社大塚製薬工場 複室バッグ
CN202863949U (zh) * 2012-08-09 2013-04-10 安保包装（深圳）有限公司 易剥离开启的灭菌包装顶头袋
CN103156770A (zh) * 2013-04-03 2013-06-19 上海武彬包装制品有限公司 一种大容量粉液袋容器的生产方法

Also Published As

Publication number Publication date
FR3058638B1 (fr) 2022-01-14
WO2018091809A1 (fr) 2018-05-24
CO2019006267A2 (es) 2020-01-17
MX2019005708A (es) 2019-10-21
US20200060934A1 (en) 2020-02-27
BR112019009948A2 (pt) 2019-08-13
KR20190099404A (ko) 2019-08-27
AU2017361942A1 (en) 2019-06-13
CN110402132A (zh) 2019-11-01
JP2020503914A (ja) 2020-02-06
CA3044015A1 (en) 2018-05-24
ES2967414T3 (es) 2024-04-30
FR3058638A1 (fr) 2018-05-18
EP3541344B1 (de) 2023-10-25
EP3541344C0 (de) 2023-10-25

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