EP0390898B1 - Behälter zur getrennten, sterilen aufbewahrung mindestens zweier substanzen und zur vermischung dieser substanzen - Google Patents

Behälter zur getrennten, sterilen aufbewahrung mindestens zweier substanzen und zur vermischung dieser substanzen Download PDF

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Publication number
EP0390898B1
EP0390898B1 EP19890911020 EP89911020A EP0390898B1 EP 0390898 B1 EP0390898 B1 EP 0390898B1 EP 19890911020 EP19890911020 EP 19890911020 EP 89911020 A EP89911020 A EP 89911020A EP 0390898 B1 EP0390898 B1 EP 0390898B1
Authority
EP
European Patent Office
Prior art keywords
chamber
container according
container
tubular section
bag
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.)
Revoked
Application number
EP19890911020
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0390898A1 (de
Inventor
Reinhold Herbert
Klaus Sommermeyer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius SE and Co KGaA
Original Assignee
Fresenius SE and Co KGaA
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=6364852&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP0390898(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Fresenius SE and Co KGaA filed Critical Fresenius SE and Co KGaA
Priority to AT89911020T priority Critical patent/ATE87197T1/de
Publication of EP0390898A1 publication Critical patent/EP0390898A1/de
Application granted granted Critical
Publication of EP0390898B1 publication Critical patent/EP0390898B1/de
Anticipated expiration legal-status Critical
Revoked legal-status Critical Current

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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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed

Definitions

  • the invention relates to a container for separate sterile storage of at least two substances and for mixing these substances according to the preamble of claim 1 or 9.
  • the invention also relates to a method for producing a sterile medical mixing arrangement according to one of claims 1 to 18.
  • Medical storage bags are among others used for the storage of infusion solutions and must therefore be heat sterilizable above 100 ° C in order to meet the usual hygienic requirements. Such bags are known for example from DE-PS 32 00 264 or DE-PS 33 05 365.
  • These can be two liquid components that are mixed before the infusion or powdered medications, such as Antibiotics or cytostatics that are in a carrier solution, e.g. an aqueous saline solution.
  • a carrier solution e.g. an aqueous saline solution.
  • Bags are known for the storage and subsequent mixing of liquid active ingredient and carrier liquid, which are based on the above-mentioned.
  • Storage bags are made. To form two chambers, these bags are welded in the middle, a pipe section and a break-off part closing the pipe section being arranged in the weld seam as a connection between the two chambers. The break-off part is broken off before the infusion and then falls into the interior of one chamber. The liquid can then be transferred from one chamber to the second chamber, while maintaining the required sterility.
  • Such an infusion bag consisting of two chambers is also known from German utility model 77 19 528.
  • Several infusion solutions can be stored and applied separately in this infusion bag.
  • the two chambers are separated from each other by welds, in which an easy-to-open breaking cannula is attached, which is divided into several parts.
  • Another problem is that the required sterilization of the plastic bag cannot prevent water vapor from diffusing through the bag wall into the inside of the bag.
  • the inside of most bags bond inseparably to one another during sterilization without filling. Since the powder, which can only be filled in after heat sterilization and which can be, for example, antibiotics or cytostatics, must be kept dry in the container, it would be necessary in a further production step to remove the diffused water again, which would be associated with the corresponding effort .
  • US-A-4,507,114 shows the arrangement of two interconnected flexible bags, the interior of which can be connected via a tube section which is closed by a break-off part in the non-operational state. The tube cutout is opened by breaking off the break-off part, so that the contents of the upper bag can flow into the lower bag.
  • This configuration may be functional in the case of liquids, but this configuration cannot be used in the desired mixture of a powdery substance with a liquid substance.
  • US-A-4,606,734 shows a flexible bag which is provided at its upper area with a tubular adapter into which a rigid container can be inserted. The contents of the rigid container can be passed into the flexible container by opening the adapter.
  • This embodiment does not meet the requirements, particularly with regard to sterility, since the adapter cannot be attached in a sterile manner. Furthermore, it is not possible to store or transport the container as a unit, in which two medical substances are kept sterile.
  • the object of the invention is to provide a container and a mixing arrangement which allows two media (powder and liquid) to be stored under sterile conditions and to be mixed with one another in a simple manner under sterile conditions.
  • the mixing arrangement according to the invention has a first chamber made of an essentially rigid material with a tube section, the end part of which is closed and designed as a break-off part.
  • the tube section is welded into the bag edge in such a way that the break-off part is located in the interior of the bag and, after breaking off, releases the first substance for filling into the first rammer.
  • the container according to the invention is first manufactured and then the first chamber is closed and radiation sterilization with e ⁇ or ⁇ rays of the entire container is carried out. This pre-sterilization is particularly important for the first chamber.
  • the aqueous solution or carrier solution is then poured into the second chamber and the latter is closed. This is followed by heat sterilization of the entire container, with the closed first chamber being re-sterilized at the same time.
  • the rigid material of the first chamber preferably consists of polycarbonate, rigid PVC or polypropylene, there is no risk that liquid will penetrate into the first chamber and thus spoil the powdery material.
  • the first chamber can then be opened while maintaining the sterile conditions and, under sterile conditions, for example under laminar flow, a powdered medicament can be introduced into the first chamber, which is then closed with a sterile stopper.
  • a powdered medicament can be introduced into the first chamber, which is then closed with a sterile stopper.
  • the previous heat sterilization can be carried out with an outer bag, which is removed during the introduction. The entire bag is thus sterile on the outside.
  • Such a way of filling is particularly advantageous in the case of powdered pharmaceutical substances which are sensitive to heat and may only be filled at room temperature.
  • the filled and sterilized container can be hung directly on the bedside, where a nurse or doctor only has to break off the break-off part before the infusion in order to get the to bring both substances together.
  • the break-off part falls into the second chamber, and at the same time opens the connection opening to the first chamber arranged above it, so that the powdered or liquid medicament slips down into the second chamber without any further manipulations and especially under sterile conditions.
  • the fact that the first chamber consists of a rigid material and is preferably funnel-shaped ensures that no powdery material remains in the first chamber.
  • the first chamber can also be rinsed out with the carrier solution.
  • an appropriate infusion tube is connected to the outlet opening, which is provided with a membrane and a cap or a pierceable insert.
  • the pipe section which establishes the connection between the first and the second chamber and the break-off part preferably consist of the same material as the first chamber.
  • the pipe section is preferably welded into the edge of the second chamber, which consists of a plastic bag, and the material of the pipe section can be welded in either directly with the bag material or via an intermediate layer made of an additional welding material (for example according to DE-PS 3305365).
  • the first chamber has a capacity of 2 to 50 ml and the second chamber a capacity of 50 to 250 ml.
  • the container according to the invention has a first chamber 2 and a second chamber 3.
  • the chamber serves to receive the powdery substance 17 and is closed with a stopper 9 and a crimp cap 11.
  • a closure can also be welded to the edge 16.
  • the chamber 2 is generally funnel-shaped and merges with its tapered end 15 into the pipe section 10, which is closed at its lower end with the break-off part 4.
  • the pipe section 10 is welded into the welding edge 5 of the second chamber 3.
  • This second chamber 3 preferably consists of a plastic film and contains the carrier solution 18.
  • This plastic bag 3 has a hanger 8 at the upper end.
  • the outlet opening 6 is located at the lower end of this bag.
  • a further pipe section 14 or a hose is inserted, which is closed at the lower end with a conventional connecting part 12 with a plug 9 'and a cap 11'.
  • the closure element is displaceable in the form of a formed on the second chamber 2, which is provided with an O-ring seal 22.
  • the piston In the sealing position shown in Figure 2a, the piston is in sealing engagement with the pipe section 10 and has a piston rod 20 which extends through the Interior of the first chamber 2.
  • the upper end of the first chamber 2 is closed by means of an elastic wall 21 which is held on an upper flange of the first chamber 2 by means of a retaining ring 23.
  • the piston rod 20 extends to the underside of the elastic wall 21.
  • FIG. 2b shows the open position of the first chamber 2, it being evident that the piston 19 or the piston rod 20 connected to it can be moved into the open position by an elastic, manually caused deformation of the elastic wall 21.
  • the piston rod 20 is guided in a manner not shown on the first chamber 2, for example by means of a separate spacer element, which at the same time also serves as a captive device to prevent the piston 19 from falling off the first chamber 2 in the open position.
  • FIG. 2 c shows a detailed view of the locking piston 19 as well as the O-ring seal 22 and the piston rod 20.
  • the rod 20 can be provided with a spacer 25, which in the example may consist of four star-shaped arms 26 which point radially outwards and are supported on the inner wall 27 of the cylindrical main part of the container 2 can.
  • a certain frictional force is applied, which holds the piston 19 securely in its closed and open position.
  • the closure device according to the invention is extremely simple to manufacture and can be actuated in a safe manner, it also being possible, if necessary, to move the piston 11 back from its open position shown in FIG. 2 back to its closed position, for which purpose pressure is applied to the end flange 16 is required, which prevents damage to the sealing portion 15, since it engages radially on the outside.

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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Package Specialized In Special Use (AREA)
  • Packages (AREA)
EP19890911020 1988-10-11 1989-10-10 Behälter zur getrennten, sterilen aufbewahrung mindestens zweier substanzen und zur vermischung dieser substanzen Revoked EP0390898B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT89911020T ATE87197T1 (de) 1988-10-11 1989-10-10 Behaelter zur getrennten, sterilen aufbewahrung mindestens zweier substanzen und zur vermischung dieser substanzen.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3834566 1988-10-11
DE19883834566 DE3834566A1 (de) 1988-10-11 1988-10-11 Behaelter zur sterilen, getrennten aufbewahrung mindestens zweier substanzen und zur vermischung derselben

Publications (2)

Publication Number Publication Date
EP0390898A1 EP0390898A1 (de) 1990-10-10
EP0390898B1 true EP0390898B1 (de) 1993-03-24

Family

ID=6364852

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19890911020 Revoked EP0390898B1 (de) 1988-10-11 1989-10-10 Behälter zur getrennten, sterilen aufbewahrung mindestens zweier substanzen und zur vermischung dieser substanzen

Country Status (9)

Country Link
US (1) US5257986A (enrdf_load_stackoverflow)
EP (1) EP0390898B1 (enrdf_load_stackoverflow)
JP (1) JPH03502657A (enrdf_load_stackoverflow)
AU (1) AU617883B2 (enrdf_load_stackoverflow)
DE (2) DE3834566A1 (enrdf_load_stackoverflow)
DK (1) DK140390A (enrdf_load_stackoverflow)
HU (1) HU210255B (enrdf_load_stackoverflow)
NO (1) NO179693C (enrdf_load_stackoverflow)
WO (1) WO1990003775A1 (enrdf_load_stackoverflow)

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US6207107B1 (en) 1992-10-05 2001-03-27 Baxter International Inc. Steam sterilizable system for inactivating viral contaminants in body fluids
US5951160A (en) * 1997-11-20 1999-09-14 Biomet, Inc. Method and apparatus for packaging, mixing and delivering bone cement
US6071270A (en) 1997-12-04 2000-06-06 Baxter International Inc. Sliding reconstitution device with seal
US5954230A (en) * 1997-12-08 1999-09-21 3M Innovative Properties Company Device and method for mixing and dispensing multipart solutions
US7074216B2 (en) 1998-09-15 2006-07-11 Baxter International Inc. Sliding reconstitution device for a diluent container
US6022339A (en) 1998-09-15 2000-02-08 Baxter International Inc. Sliding reconstitution device for a diluent container
US20050137566A1 (en) 2003-12-23 2005-06-23 Fowles Thomas A. Sliding reconstitution device for a diluent container
US7358505B2 (en) 1998-09-15 2008-04-15 Baxter International Inc. Apparatus for fabricating a reconstitution assembly
AR021220A1 (es) 1998-09-15 2002-07-03 Baxter Int DISPOSITIVO DE CONEXIoN PARA ESTABLECER UNA COMUNICACIoN FLUíDA ENTRE UN PRIMER RECIPIENTE Y UN SEGUNDO RECIPIENTE.
IT1302713B1 (it) * 1998-10-20 2000-09-29 Acs Dobfar Spa Sacco per conservare e trasportare prodotti sterili in polvere e performare nel sacco stesso soluzioni di tali prodotti.
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
AT409800B (de) * 1999-09-13 2002-11-25 Hoffmann La Roche Verfahren und vorrichtung zur verbesserung der lagerfähigkeit tonometrierter flüssigkeiten
DE10041295B4 (de) * 2000-08-23 2006-06-08 Fresenius Kabi Deutschland Gmbh Verfahren zur Herstellung einer Zweikammer-Anordnung
US7168459B2 (en) * 2002-04-12 2007-01-30 Hynetics Llc Feed bags and methods of use
US6752264B2 (en) * 2002-07-03 2004-06-22 Sonoco Development, Inc. Flexible pouch having system for mixing two components
JP4800962B2 (ja) * 2003-11-10 2011-10-26 ミン リー、ジュン パウチ容器の異種物質を混合する方法及び構造
US7641851B2 (en) 2003-12-23 2010-01-05 Baxter International Inc. Method and apparatus for validation of sterilization process
CN100388955C (zh) * 2004-03-18 2008-05-21 湖南千山制药机械股份有限公司 混药嘴具有穿刺功能的输液袋
DE102004021990B3 (de) * 2004-05-04 2005-11-10 Fresenius Kabi Deutschland Gmbh Medizinischer Behälter zum Verabreichen einer Flüssigkeit aus einer Trägerlösung und einem zugemischten Medikament
JP5467154B2 (ja) 2009-07-24 2014-04-09 イー・エム・デイー・ミリポア・コーポレイシヨン 供給バッグ構造
EP2386286A1 (en) * 2010-05-10 2011-11-16 B. Braun Melsungen AG Handling
CN102727380A (zh) * 2011-04-15 2012-10-17 上海武彬包装制品有限公司 一种改进的固液双室输液容器
KR101961945B1 (ko) * 2017-03-07 2019-03-25 주식회사 플라즈맵 멸균제를 밀봉하여 보관하는 멸균 포장 용기
KR101964383B1 (ko) * 2017-08-25 2019-04-01 씨제이헬스케어 주식회사 의료용 수액백
JP7370343B2 (ja) 2018-05-18 2023-10-27 バクスター・インターナショナル・インコーポレイテッド 二重チャンバ可撓性容器、作製方法、およびそれを使用する薬物製品

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Also Published As

Publication number Publication date
DK140390A (da) 1990-07-04
NO179693C (no) 1996-12-04
HUT55217A (en) 1991-05-28
JPH03502657A (ja) 1991-06-20
DE58903890D1 (de) 1993-04-29
DE3834566C2 (enrdf_load_stackoverflow) 1993-07-08
NO179693B (no) 1996-08-26
HU895716D0 (en) 1990-11-28
EP0390898A1 (de) 1990-10-10
DK140390D0 (da) 1990-06-08
US5257986A (en) 1993-11-02
DE3834566A1 (de) 1990-04-12
NO902569D0 (no) 1990-06-11
NO902569L (no) 1990-06-11
WO1990003775A1 (de) 1990-04-19
AU4340589A (en) 1990-05-01
AU617883B2 (en) 1991-12-05
HU210255B (en) 1995-03-28

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