EP1035823A1 - Multiple compartment container for medical solution - Google Patents

Multiple compartment container for medical solution

Info

Publication number
EP1035823A1
EP1035823A1 EP98959333A EP98959333A EP1035823A1 EP 1035823 A1 EP1035823 A1 EP 1035823A1 EP 98959333 A EP98959333 A EP 98959333A EP 98959333 A EP98959333 A EP 98959333A EP 1035823 A1 EP1035823 A1 EP 1035823A1
Authority
EP
European Patent Office
Prior art keywords
glucose
concentration
calcium
contents
compartment
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.)
Withdrawn
Application number
EP98959333A
Other languages
German (de)
English (en)
French (fr)
Inventor
Anders Wieslander
Bengt Rippe
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.)
Gambro AB
Original Assignee
Gambro AB
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 Gambro AB filed Critical Gambro AB
Publication of EP1035823A1 publication Critical patent/EP1035823A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61M1/1668Details 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
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/287Dialysates therefor
    • 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
    • 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
    • A61J1/2027Separating means having frangible parts
    • 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
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation

Definitions

  • the present invention relates to peritoneal dialysis, where a dialysis solution is present in a multiple compartment container provided with three or more compartments.
  • the invention relates particularly to such a container in which the dialysis solution contains bicarbonate as buffer, as well as glucose and calcium ions.
  • a container for peritoneal dialysis is disclosed in WO 97/05852.
  • the container contains conventional dialysis solution with lactate as buffer.
  • the container thus comprises a first large compartment containing sodium lactate, sodium chloride, calcium chloride and magnesium chloride, as well as two small compartments containing glucose of high concentration and low pH.
  • the container is sterilized in an autoclave with the solutions in situ in said compartments.
  • either one or both of the compartments are connected to the large compartment by frangible pins whereby the dialysis solution contains a desired concentration of glucose, such as 1.5%, 2.5% or 4%.
  • Using a three compartment container it is possible to employ a single container for all three degrees of concentration, which reduces costs for logistics and storage.
  • An object to the present invention is to adapt the container according to WO 97/05852 for such type of peritoneal dialysis in which the lactate buffer is entirely or partially exchanged for a buffer consisting of bicarbonate.
  • bicarbonate cannot, however, be combined with calcium or magnesium in the large compartment since this may lead to precipitation of, for example, carbonates during long term storage or at high pH. Accordingly, bicarbonate and calcium/magnesium must be separated until shortly before use.
  • Glucose and calcium/magnesium are largely compatible, i.e. they do not precipitate.
  • the divalent ions catalyse glucose decomposition to a certain extent .
  • a conventional peritoneal dialysis solution has a calcium ion concentration of 1.75 mM (mmol/1) and a magnesium ion concentration between 0.25-0.50 mM.
  • the buffer may be solely bicarbonate which thereby normally exists at a concentration of 30-40 mM or a combination of bicarbonate and lactate, for example 25 mM bicarbonate and 15 mM lactate.
  • a further object of the present invention is to propose a three compartment container of the above-mentioned type in which the above-mentioned problem is solved.
  • hypocalciemia results in i.a. the following symptoms: cramps, hyper-reflexes, spasms, ECG- changes and hyperparatyroidism.
  • hypocalciemia is normally counteracted by increased intake of calcium carbonate, while the calcium concentration in the dialysis solution is normally kept constant .
  • a peritoneal dialysis solution is to be neutral (in- and outflow the same) with regard to the calcium transport during a four hour period, it should comprise about 1.2 mM calcium at 1.5% glucose, about 1.6 mM at 2.5% glucose and, finally, about 2.3 mM calcium at 4.0% glucose, i.e. the calcium concentration should be substantially proportional to the glucose concentration in the final solution.
  • the final glucose concentration in the mixed solution is determined by the volume of the small compartments since the glucose concentration is identical in the small glucose compartments, for example 50%. This results in that the calcium concentration will always remain proportional to the glucose concentration. The higher the glucose concentration (greater volume) , the more ultrafiltration and thus also higher calcium concentration in the mixed solution.
  • the calcium concentration may in that respect be selected so that the patient either has a net loss, net gain or neutral calcium balance irrespective of the ultra- filtration and the glucose concentration.
  • a further object in the present invention is to provide a three compartment container of the above-mentioned type with bicarbonate in the large compartment and glucose together with calcium in the two small compartments, whereby the increase in the calcium concentration at the highest glucose concentration results in better calcium control than previously.
  • This invention is completely different from previously known methods in which the same calcium concentration has always been used irrespective of the glucose concentration.
  • the large compartment comprises bicarbonate ions and the small compartments comprises glucose and calcium ions .
  • the glucose concentration is substantially proportional to the calcium ion concentration in the finally prepared medical solution.
  • the two small compartments may comprises solutions having the same concentration of glucose and calcium, though having different volumes, or the first of the small compartments contains glucose and calcium ions with such a concentration that the glucose concentration when mixing the contents of said first small compartment with the contents of the large comparment obtains a first predetermined value, such as 1.5%, and the calcium ion concentration obtains a second predetermined value, such as 1.0 mM, while the second of the small compartments contains glucose and calcium ions having such a concentration so that the glucose concentration in the finally prepared solution when mixing the contents of said second small compartment with the contents of the large comparment obtains a third predetermined value, such as 2.5%, and the calcium ion concentration obtains a fourth predetermined value, such as 1.6 mM, and finally the contents of the first and the second of the small compartments may be mixed with the contents of the large compartment to obtain a finally prepared solution with higher concentrations of glucose and calcium ions, such as 4% glucose concentration and 2.5 mM calcium.
  • a first predetermined value such as 1.5%
  • the small compartments may further comprise magnesium ions, for example in a concentration such that the resulting concentration in the finally prepared medical solution is about 0.25-0.75 mM.
  • the invention also relates to a method for preparing a medical solution, particularly for peritoneal dialysis, in a container consisting of a first large compartment having a volume which is sufficiently large to contain the finally prepared medical solution, and a plurality of small compartments which contain partial quantities of the medical solution which are not compatible for long term storage with the contents of the large compartment.
  • the large compartment comprises bicarbonate ions and the small compartments comprise glucose and calcium ions.
  • the contents of one or more of the small compartments are mixed with the contents of the large compartment to produce a medical solution in which the concentration of glucose is substantially proportional to the concentration of calcium ions.
  • the invention also relates to a use of a container for preparation of a peritoneal dialysis solution in which the concentrations of glucose and calcium ions are substantially proportional.
  • Fig. 1 is a plan view of a container which may be used in the present invention.
  • Figs. 2, 3 and 4 are computer-simulated diagrams which show the calcium balance across the peritoneal membrane.
  • Fig. 1 discloses a three compartment container which may be used in the present invention.
  • the container 1 is of the type which is sealed at both ends with weld seams 20 and 21.
  • the container is divided into a large compartment 10 and two small compartments 14 and 15 by weld seams 11, 12 and 13.
  • the small compartment 14 and/or 15 may communicate with the large compartment 10 by means of frangible pins 18, 19 which are normally sealed but can be manually opened. When the frangible pin 18 and/or 19 is opened, the contents in the compartments 14 and/or 15 flow down into the large compartment
  • suitable solution is supplied to the various compartments 10, 14 and 15 via inlet tubes 16, 17 and 22 extending through the weld seams 20 and 21.
  • a sample and/or infusion port 23 extending through the weld seam 21 permits sampling from, and infusion to, the compartment 10.
  • the solution in the compartment 10 is supplied to a patient via a conduit 24.
  • the container is placed on a stand by means of an opening 25 in the upper weld seam 20.
  • the bag described so far is substantially identical to the one disclosed in WO 97/05852.
  • the container preferably has a size such that two litres of peritoneal dialysis solution are accommodated in the large compartment 10 in a ready-mixed state. Larger or smaller containers are of course feasible according to the invention.
  • the container 1 is to be used to prepare a peritoneal dialysis solution in which the buffer consists of bicarbonate. Accordingly, the solutions in the various compartments may be the following.
  • EXAMPLE 1 The compartment 10 contains 1900 ml with the composition:
  • Compartment 14 contains 100 ml of the composition:
  • Compartment 15 contains 100 ml of the composition:
  • a peritoneal dialysis solution is obtained with the following composition:
  • a dialysis solution having the following composition:
  • each of the small compartments has the same composition according to the following:
  • Compartment 10 contains 1950 ml of the composition:
  • Compartment 14 contains 60 ml of the composition:
  • solutions are employed with the following compositions in the various compartments 10, 14 and 15.
  • Compartment 10 contains 1850 ml of the composition:
  • Compartment 14 contains 150 ml of the composition:
  • Compartment 15 contains 260 ml of the composition:
  • the calcium concentration will be somewhat lower than in the first two examples .
  • the pH- value in the small compartments is normally low, about 3.0, in order to prevent glucose decomposition during autoclaving.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • External Artificial Organs (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP98959333A 1997-11-28 1998-11-27 Multiple compartment container for medical solution Withdrawn EP1035823A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9704386 1997-11-28
SE9704386A SE512349C2 (sv) 1997-11-28 1997-11-28 Flerkammarbehållare för medicinsk lösning, förfarnde för beredning av medicinsk lösning för peritonealdialys samt användning av sådan behållare vid beredning av medicinsk lösning
PCT/SE1998/002146 WO1999027885A1 (en) 1997-11-28 1998-11-27 Multiple compartment container for medical solution

Publications (1)

Publication Number Publication Date
EP1035823A1 true EP1035823A1 (en) 2000-09-20

Family

ID=20409165

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98959333A Withdrawn EP1035823A1 (en) 1997-11-28 1998-11-27 Multiple compartment container for medical solution

Country Status (9)

Country Link
EP (1) EP1035823A1 (sv)
JP (1) JP2001524353A (sv)
KR (1) KR20010032191A (sv)
CN (1) CN1280481A (sv)
AU (1) AU742793B2 (sv)
BR (1) BR9815055A (sv)
CA (1) CA2311903A1 (sv)
SE (1) SE512349C2 (sv)
WO (1) WO1999027885A1 (sv)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0716607B1 (en) 1994-07-01 2002-08-28 Baxter International Inc. Biochemically balanced peritoneal dialysis solutions
JP3060133U (ja) * 1997-10-27 1999-07-30 株式会社大塚製薬工場 眼灌流・洗浄液バッグ包装体
DE19912850B4 (de) 1999-03-22 2005-04-07 Fresenius Medical Care Deutschland Gmbh Lösung, insbesondere für Hämo- oder Peritonealdialyse, sowie Verfahren zu deren Herstellung
SE9903331D0 (sv) 1999-09-16 1999-09-16 Gambro Lundia Ab Method and apparatus for sterilising a heat sensitive fluid
WO2000057928A1 (en) 1999-03-30 2000-10-05 Gambro Lundia Ab Method and apparatus for sterilising a heat sensitive fluid
US7122210B2 (en) 2002-01-11 2006-10-17 Baxter International Inc. Bicarbonate-based solutions for dialysis therapies
SE524530C2 (sv) * 2002-12-10 2004-08-24 Gambro Lundia Ab Metod för att framställa en medicinsk lösning för peritonealdialys där en lösning innehållandes ett eller flera acetylerade eller deacetylerade aminosocker värme- eller strålningssteriliseras med bestämda pH-värden och med bestämda viktsprocent för att undvika att cytotoxiska produkter bildas.
KR101142863B1 (ko) 2002-12-10 2012-05-21 프레제니우스 메디칼 케어 도이칠란드 게엠베하 복막 투석용 약제를 제조하기 위한 의료용 용액의 제조방법
JP4361493B2 (ja) * 2002-12-10 2009-11-11 ガンブロ・ルンディア・エービー 腹膜透析用薬剤の製造のための医学的溶液を調製する方法
SE524531C2 (sv) * 2002-12-10 2004-08-24 Gambro Lundia Ab Metod för att framställa en medicinsk lösning för peritonealdialys där en lösning innehållandes ett eller flera acetylerade eller deacetylerade aminosocker värme- eller strålningssteriliseras med bestämda pH-värden och med bestämda viktsprocent för att undvika att cytotoxiska produkter bildas
SE0301577L (sv) 2003-05-28 2004-11-29 Gambro Lundia Ab Lösning med låg natriumhalt
US9004761B2 (en) 2006-05-01 2015-04-14 Baxter International Inc. Multiple chamber container with mistake proof administration system
DE102010039489A1 (de) * 2010-08-18 2012-02-23 Fresenius Medical Care Deutschland Gmbh Konzentrat
DK3003358T3 (da) 2013-06-07 2021-06-21 Allena Pharmaceuticals Inc Sammensætninger og anordninger til dialyse
DK178893B1 (en) * 2015-07-05 2017-05-01 Dorte Dyrsborg Intravenous Bag
JP6578474B2 (ja) * 2015-09-03 2019-09-25 レジメンキット株式会社 キット製剤及び用量調整方法
DE102018103937A1 (de) * 2018-02-21 2019-08-22 Fresenius Medical Care Deutschland Gmbh Vorrichtung enthaltend Dialyselösung oder Dialyselösungskonzentrat
EP3838246A4 (en) 2018-08-17 2022-11-23 Regimen Kit, Inc. DRUG MANAGEMENT METHOD FOR KIT FORMULATION REQUIRING DOSE ADJUSTMENT

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CH686778A5 (fr) * 1987-05-29 1996-06-28 Vifor Medical Ag Récipient destiné au stockage séparé de composés actifs et à leur mélange subséquent.
EP0442406B1 (en) * 1990-02-14 1995-07-26 Material Engineering Technology Laboratory, Inc. Filled and sealed, self-contained mixing container

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9927885A1 *

Also Published As

Publication number Publication date
CA2311903A1 (en) 1999-06-10
CN1280481A (zh) 2001-01-17
WO1999027885A1 (en) 1999-06-10
KR20010032191A (ko) 2001-04-16
AU742793B2 (en) 2002-01-10
JP2001524353A (ja) 2001-12-04
SE9704386L (sv) 1999-05-29
SE9704386D0 (sv) 1997-11-28
AU1515399A (en) 1999-06-16
SE512349C2 (sv) 2000-03-06
BR9815055A (pt) 2002-04-30

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