BR112013024709A2 - Recipiente e método para a preparação de uma solução médica a partir de vários concentrados - Google Patents

Recipiente e método para a preparação de uma solução médica a partir de vários concentrados

Info

Publication number
BR112013024709A2
BR112013024709A2 BR112013024709A BR112013024709A BR112013024709A2 BR 112013024709 A2 BR112013024709 A2 BR 112013024709A2 BR 112013024709 A BR112013024709 A BR 112013024709A BR 112013024709 A BR112013024709 A BR 112013024709A BR 112013024709 A2 BR112013024709 A2 BR 112013024709A2
Authority
BR
Brazil
Prior art keywords
solution
container
concentrates
electrical conductivity
preparing
Prior art date
Application number
BR112013024709A
Other languages
English (en)
Other versions
BR112013024709B1 (pt
Inventor
Kugelmann Franz
Hoermann Joern
Original Assignee
Fresenius Medical Care Deutschland Gmbh
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 Fresenius Medical Care Deutschland Gmbh filed Critical Fresenius Medical Care Deutschland Gmbh
Publication of BR112013024709A2 publication Critical patent/BR112013024709A2/pt
Publication of BR112013024709B1 publication Critical patent/BR112013024709B1/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2024Separating means having peelable seals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093Containers having several compartments for products to be mixed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • A61M1/1666Apparatus for preparing dialysates by dissolving solids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • A61M1/1668Details of containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • A61M1/1668Details of containers
    • A61M1/167Flexible packaging for solid concentrates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers

Landscapes

  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Emergency Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • External Artificial Organs (AREA)

Abstract

RECIPIENTE E MÉTODO PARA PREPARAÇÃO DE UMA SOLUÇÃO MÉDICA A PARTIR DE VÁRIOS CONCENTRADOS. O objeto da presente invenção é um recipiente com múltiplas câmaras e um método para a preparação de fluidos medicinais, compostos de concentrados que fazem uma contribuição para a condutividade elétrica da solução e também são preparados a partir de concentrados, que não contribuem para a condutividade elétrica da solução. O recipiente pelo fato de que os componentes da solução são divididos em várias câmaras que são construídas de modo que, após a dissolução, devido à abertura quebrando da primeira borda da câmara de um componente da solução, o que faz uma contribuição para a condutividade elétrica da solução médica, outra borda da câmara de outro componente da solução, o que não contribui para a condutividade elétrica da solução, é aberta quebrando.
BR112013024709-6A 2011-04-14 2012-04-12 Recipiente e método para a preparação de uma solução médica a partir de vários concentrados BR112013024709B1 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161475405P 2011-04-14 2011-04-14
DE102011017048.0 2011-04-14
DE201110017048 DE102011017048A1 (de) 2011-04-14 2011-04-14 Mehrkammercontainer zur Herstellung medizinischer Lösungen
US61/475,405 2011-04-14
PCT/EP2012/001578 WO2012139753A1 (de) 2011-04-14 2012-04-12 Mehrkammercontainer zur herstellung medizinischer lösungen

Publications (2)

Publication Number Publication Date
BR112013024709A2 true BR112013024709A2 (pt) 2017-10-03
BR112013024709B1 BR112013024709B1 (pt) 2021-04-13

Family

ID=46935509

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013024709-6A BR112013024709B1 (pt) 2011-04-14 2012-04-12 Recipiente e método para a preparação de uma solução médica a partir de vários concentrados

Country Status (9)

Country Link
US (1) US9132220B2 (pt)
EP (1) EP2696910B1 (pt)
JP (1) JP6198716B2 (pt)
CN (1) CN103458937B (pt)
AU (1) AU2012242238B2 (pt)
BR (1) BR112013024709B1 (pt)
DE (1) DE102011017048A1 (pt)
ES (1) ES2589029T3 (pt)
WO (1) WO2012139753A1 (pt)

Families Citing this family (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7736328B2 (en) 2007-07-05 2010-06-15 Baxter International Inc. Dialysis system having supply container autoconnection
DE102011011883B4 (de) * 2011-02-21 2015-09-03 Scaldopack Sprl. Verpackung für ein flüssiges Füllgut sowie Verfahren und Vorrichtung zu dessen Herstellung
US9861733B2 (en) 2012-03-23 2018-01-09 Nxstage Medical Inc. Peritoneal dialysis systems, devices, and methods
CN103619372A (zh) 2011-03-23 2014-03-05 纳科斯达格医药股份有限公司 腹膜透析系统、装置和方法
WO2012150632A1 (ja) * 2011-05-02 2012-11-08 株式会社モリモト医薬 投薬用容器
DE102011106248A1 (de) * 2011-07-01 2013-01-03 Fresenius Medical Care Deutschland Gmbh Behälter, Verwendung, Dialysegerät oder Zubereitungseinheit sowie Verfahren zur Herstellung eines Konzentrats
FR2978914B1 (fr) 2011-08-11 2013-08-16 Fresenius Medical Care De Gmbh Recipient pour dialyse
DE102012007697A1 (de) * 2012-04-19 2015-08-13 Fresenius Medical Care Deutschland Gmbh Beutel mit Strömungsausgleich
EP2991596B1 (en) * 2013-05-02 2017-06-21 Ugarte, Roland Rene A catheter collection and drainage device
ITBO20130267A1 (it) * 2013-05-28 2014-11-29 Bellco Srl Metodo per produrre una sacca contenente bicarbonato in polvere
ITBO20130266A1 (it) * 2013-05-28 2014-11-29 Bellco Srl Sacca contenente bicarbonato in polvere
DE102013108082A1 (de) * 2013-07-29 2015-01-29 B. Braun Avitum Ag Vorrichtung zum Herstellen einer Lösung, inbesondere in/an einer Dialysemaschine
DE202014104252U1 (de) * 2014-09-09 2015-12-11 Nephtec Gmbh Behälter zur Herstellung von Dialysekonzentraten
JP6931266B2 (ja) * 2014-10-23 2021-09-01 ニプロ株式会社 透析用剤充填体
AU2017261342A1 (en) 2016-05-06 2018-12-13 Gambro Lundia Ab Systems and methods for peritoneal dialysis having point of use dialysis fluid preparation using water accumulator and disposable set
JP6841700B2 (ja) * 2017-03-28 2021-03-10 日機装株式会社 薬剤容器、及び、これを用いた薬剤溶解装置
US20200061272A1 (en) * 2017-05-05 2020-02-27 Fresenius Medical Care Deutschland Gmbh Peritoneal Dialysis Concentrate, Peritoneal Dialysis Bag and Set for Continuous Ambulatory Peritoneal Dialysis or Automated Peritoneal Dialysis
EP3703774A1 (en) * 2017-11-01 2020-09-09 Baxter International Inc Mixing for online medical fluid generation
WO2019131119A1 (ja) * 2017-12-26 2019-07-04 日機装株式会社 透析液用容器
DE102018103866A1 (de) * 2018-02-21 2019-08-22 Fresenius Medical Care Deutschland Gmbh Vorrichtung enthaltend eine Dialyseslösung
US11207454B2 (en) 2018-02-28 2021-12-28 Nxstage Medical, Inc. Fluid preparation and treatment devices methods and systems
USD900311S1 (en) 2018-05-18 2020-10-27 Baxter International Inc. Dual chamber flexible container
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
DE102018121675A1 (de) * 2018-09-05 2020-03-05 Fresenius Medical Care Deutschland Gmbh Behälteranordnung, Verfahren zur Befüllung einer Behälteranordnung und Verwendung einer Lösung als Dialyselösung
DE102018121688A1 (de) * 2018-09-05 2020-03-05 Fresenius Medical Care Deutschland Gmbh Behälter, Verfahren zur Befüllung eines Behälters und Verwendung einer Lösung als Dialyselösung
EP3866877A2 (en) * 2018-10-19 2021-08-25 Staymed AB A device and system providing a medical solution and a method thereof
FR3089126B1 (fr) * 2018-11-30 2020-12-18 Fresenius Medical Care Deutschland Gmbh Poche pour concentré solide
US11944586B2 (en) * 2021-05-25 2024-04-02 Baxter International Inc. Containers with selective dissolved gas content
WO2023085999A1 (en) * 2021-11-09 2023-05-19 Staymed Ab A device and system providing a medical solution and a method thereof

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4386634A (en) 1980-10-10 1983-06-07 Renal Systems, Inc. Proportioning system
DE4139165C2 (de) * 1991-11-28 1994-12-08 Fresenius Ag Einrichtung zur Herstellung einer medizinischen Flüssigkeit
US5932110A (en) 1995-02-13 1999-08-03 Aksys, Ltd. Dialysate conductivity adjustment in a batch dialysate preparation system
DE19605357A1 (de) * 1996-02-14 1997-08-21 Braun Melsungen Ag Flexibler Kunststoffbehälter
FR2766797B1 (fr) * 1997-07-30 1999-09-17 Smad Conditionnement pour au moins une matiere solide, notamment sous forme granuleuse ou pulverulente
DE19751489A1 (de) 1997-11-20 1999-05-27 Nutrichem Diaet & Pharma Gmbh Doppelbeutel zur Applikation einer fluiden Substanz
DE19809945C2 (de) * 1998-03-07 2002-02-21 Fresenius Medical Care De Gmbh Vorrichtung zur Bereitstellung von Dialysierflüssigkeit mit einer Einrichtung zur Überwachung ausgewählter Parameter der Dialysierflüssigkeit und Verfahren zur Überwachung ausgewählter Parameter der Dialysierflüssigkeit bei einer Dialysebehandlung
WO2000057833A1 (en) * 1999-03-25 2000-10-05 Gambro Lundia Ab Method and supply bag for providing a medical solution
EP1059083B1 (en) 1999-06-07 2004-04-14 Nipro Corporation A solid pharmaceutical preparation for dialysis and a process for producing the same
DE10162959B4 (de) 2001-12-20 2017-10-12 Fresenius Medical Care Deutschland Gmbh Behälter enthaltend mindestens zwei Feststoffe und dessen Verwendung
JP4581331B2 (ja) * 2003-03-25 2010-11-17 味の素株式会社 薬剤入り多室バッグ
EP1621177A1 (en) * 2004-07-29 2006-02-01 Fresenius Kabi Deutschland GmbH Medical container with improved peelable seal
US7544301B2 (en) * 2004-08-19 2009-06-09 Hhd Llc Citrate-based dialysate chemical formulations
JP4656302B2 (ja) * 2005-03-25 2011-03-23 藤森工業株式会社 複室容器
JP5352453B2 (ja) * 2006-06-15 2013-11-27 メットプロ アーベー 溶液を提供するための容器、システムならびに方法
JP5100308B2 (ja) * 2006-10-27 2012-12-19 株式会社大塚製薬工場 溶存酸素量が低減された薬液収容体
CA2671416C (en) * 2006-12-07 2015-11-24 Gambro Lundia Ab Multicompartment container
ES2717616T3 (es) 2007-12-24 2019-06-24 Choongwae Corp Utilización de una película multicapa para recipiente de disolución médica y recipiente que comprende la misma
US20090166363A1 (en) * 2007-12-27 2009-07-02 Baxter International Inc. Multi-chambered containers
DE102010014785A1 (de) 2010-04-13 2011-10-13 Fresenius Medical Care Deutschland Gmbh Mehrschichtfolie, Verwendung einer Mehrschichtfolie und Verfahren zur Herstellung einer Mehrschichtfolie
DE102010039489A1 (de) 2010-08-18 2012-02-23 Fresenius Medical Care Deutschland Gmbh Konzentrat

Also Published As

Publication number Publication date
JP2014514075A (ja) 2014-06-19
EP2696910B1 (de) 2016-06-01
ES2589029T3 (es) 2016-11-08
AU2012242238A1 (en) 2013-11-07
WO2012139753A1 (de) 2012-10-18
DE102011017048A1 (de) 2012-10-18
AU2012242238B2 (en) 2016-05-19
US20120288572A1 (en) 2012-11-15
US9132220B2 (en) 2015-09-15
EP2696910A1 (de) 2014-02-19
CN103458937B (zh) 2016-09-28
CN103458937A (zh) 2013-12-18
JP6198716B2 (ja) 2017-09-20
BR112013024709B1 (pt) 2021-04-13

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Legal Events

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B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B15K Others concerning applications: alteration of classification

Free format text: AS CLASSIFICACOES ANTERIORES ERAM: A61M 1/16 , A61J 1/20

Ipc: A61J 1/20 (1990.01), A61M 1/16 (1985.01), A61J 1/1

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 12/04/2012, OBSERVADAS AS CONDICOES LEGAIS.