WO2000057833A1 - Procede et poche distributrice - Google Patents

Procede et poche distributrice Download PDF

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Publication number
WO2000057833A1
WO2000057833A1 PCT/SE1999/000482 SE9900482W WO0057833A1 WO 2000057833 A1 WO2000057833 A1 WO 2000057833A1 SE 9900482 W SE9900482 W SE 9900482W WO 0057833 A1 WO0057833 A1 WO 0057833A1
Authority
WO
WIPO (PCT)
Prior art keywords
powder
compartment
bicarbonate
solution
electrolyte
Prior art date
Application number
PCT/SE1999/000482
Other languages
English (en)
Inventor
Helmut Becker
Anders Wieslander
Lars-Fride Olsson
Original Assignee
Gambro Lundia 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 Lundia Ab filed Critical Gambro Lundia Ab
Priority to PCT/SE1999/000482 priority Critical patent/WO2000057833A1/fr
Priority to AU33512/99A priority patent/AU3351299A/en
Publication of WO2000057833A1 publication Critical patent/WO2000057833A1/fr

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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
    • A61J1/2093—Containers having several compartments for products to be mixed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1668—Details of containers
    • A61M1/167—Flexible packaging for solid concentrates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/287—Dialysates therefor
    • 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
    • A61J1/2024—Separating means having peelable seals
    • 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
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/168—Sterilisation or cleaning before or after use
    • A61M1/1686—Sterilisation or cleaning before or after use by heat

Definitions

  • TITLE METHOD AND SUPPLY BAG FOR PROVIDING A MEDICAL SOLUTION
  • the present invention relates to a method and a supply bag for providing a medical solution such as a peritoneal dialysis (PD) solution intended to be used for performing peritoneal dialysis, for example continuous ambulatory PD (CAPD) or auto- matic PC (APD) .
  • a medical solution such as a peritoneal dialysis (PD) solution intended to be used for performing peritoneal dialysis, for example continuous ambulatory PD (CAPD) or auto- matic PC (APD) .
  • PD peritoneal dialysis
  • CAPD continuous ambulatory PD
  • APIPD auto- matic PC
  • Peritoneal dialysis is performed by introducing a peritoneal dialysis solution in the peritoneal cavity of a patient to remove waste products from blood by exchange over the peritoneal membrane of the patient. Moreover, fluid removal takes place by the use of an osmotic gradient provided by an osmotic agent, for example glucose. Electrolytes are balanced by inclusion of electrolytes in desired concentrations in the PD solu- tion.
  • the PD solution comprises lactate which is transferred to the blood.
  • the body converts lactate to bicarbonate, which is the buffer the body uses .
  • bicarbonate as a buffer in the PD fluid replacing lactate fully or partially.
  • the use of bicarbonate in solutions which must be sterilised and stored for a prolonged time results in problems, since bicarbonate is metastable and is transformed to carbonate under emission of carbon dioxide.
  • the first object of the present invention is to solve one or more of the above mentioned problems and provide a method and a PD supply bag including a PD solution comprising bicarbonate ion .
  • a second object of the invention is to provide a method and a PD solution bag in which the PD solution is stable over a prolonged storage time and can withstand sterilisation.
  • a third object of the present invention is to provide a method and a PD supply bag comprising a PD solution where the risk of calcium carbonate precipitation is minimised.
  • a method of providing a peritoneal dialysis solution intended to be used for performing peritoneal dialysis comprising the steps of providing a supply bag having multiple compartments; providing electrolyte solution in an electrolyte compartment; providing bicarbonate powder in a powder compartment; sterilising the supply bag inclusive the electrolyte solution and bicarbonate powder; shortly before use, dissolving the bicarbonate powder in said electrolyte solution to provide a perito- neal dialysis solution comprising bicarbonate.
  • the stable characteristics of the bicarbonate powder is advantageously used.
  • An osmotic agent is mixed with the electrolyte solution shortly before use, which means that the osmotic agent is sterilised separately from the remaining solution and may be sterilised under favourable conditions, such as high concentration and low pH to avoid harmful breakdown components from the osmotic agent, normally glucose.
  • the electrolyte compartment comprises sodium chloride and optionally sodium lactate, and mixing the contents of the osmotic agent compartment after dissolution of the bicarbonate powder, the risk of precipitation because of local high bicarbonate concentrations are avoided.
  • the bicarbonate powder may be provided in a pouch of a web material, which maintains said powder bicarbonate inside the pouch but allow fluid to pass for dissolution of the powder contained in the pouch.
  • the pouch may be attached to the supply bag blank during the manufacturing step.
  • a more accurate dosage of the powder bicarbonate may be obtained.
  • the bicarbonate powder is provided in a powder cartridge, which is sealed and sterilised separately, before being introduced in the powder compartment.
  • the cartridge may be provided with frangible pins to gain access to the interior of said cartridge. By sterilising the cartridge separately, the supply bag blank need not be exposed to for example gamma irradiation which might deteriorate the bag material .
  • a dissolution compartment is arranged so that electrolyte solution from the electro- lyte compartment must pass the powder compartment to enter the dissolution compartment.
  • electrolyte solution passes the bicarbonate powder, it becomes dissolved.
  • the electrolyte solution may be passed several times between the electrolyte compartment to the dissolution compartment and back to promote dissolution of the powder.
  • the dissolution compartment is arranged between the electrolyte compartment and a supply tube for supplying peritoneal dialysis solution to a patient.
  • the electrolyte solution must pass the powder compartment to reach the patient, which means that the patient cannot forget to open the bicarbonate compartment.
  • electrolyte solution may be provided in the dissolution compartment and passed from there through the bicarbonate powder to the electrolyte compartment. Then, osmotic agent is added, possibly together with calcium and magnesium ions.
  • Fig. 1 is a schematic view of a prior art double bag CAPD solution set comprising a Y-connector, for example of the type GEMINI 10 available from Gambro Lundia AB.
  • Fig. 2 is a schematic view of an alternative supply bag in the PD solution set according to Fig. 1.
  • Fig. 3 is a schematic view over a first embodiment of a supply bag according to the present invention.
  • Fig. 4 is a schematic view over a second embodiment of the supply bag according to the present invention.
  • Fig. 5 is a schematic view over a third embodiment of the supply bag according to the present invention.
  • Fig. 6 is a cross sectional view of an insert to be used in the supply bag according to Fig. 5.
  • Fig. 7 is a cross sectional view of an insert similar to Fig. 6 to be used in the supply bag according to Fig. 5.
  • Fig. 8 is a schematic view of a fourth embodiment of the supply bag according to the present invention.
  • Fig. 9 is a schematic view of a fifth embodiment of the supply bag according to the present invention.
  • Fig. 1 is a schematic view of a PD solution set comprising a supply bag 1, a drain bag 2, a Y-connector 3 and a CAPD- connector 4.
  • the supply bag 1 is connected to one leg of the Y- connector via a supply tube 5 and the drain bag 2 is connected to the Y-connector 3 via a drain tube 6.
  • the final leg of the Y-connector 3 is connected to the CAPD-connecting line- connector 4 via a delivery tube 7, which may be a double tube over a portion of its length.
  • the end of the drain tube 6 connected to the drain bag 2 is provided with a frangible pin 8.
  • the operation of the CAPD peritoneal dialysis set according to Fig. 1 is the following.
  • Supply bag 1 is attached to a stand (not shown on the drawing) to position the supply bag 1 at an elevated position, for example 1.7 meter above the floor or higher.
  • supply bag 1 is provided with a hole 9 for engagement with a hook of the stand.
  • the drain bag 2 is placed in a low position attached to the stand.
  • the patient Before placing the drain bag 2, the patient normally opens the frangible pin 8 by applying a gentle pressure sideways to break a weakened part of the pin.
  • the operation of a frangible pin is well known in the art.
  • the opening of the frangible pin 8 establishes a flow path from supply bag 1 via supply tube 5 and Y-connector 3 and further via drain tube 3 and frangible pin 8 into drain bag 2.
  • solution in supply bag starts to flow along this flow path in order to rinse it, while the patient places the drain bag on the floor.
  • the patient places a clamp 10 on the supply tube 5 to stop the flow.
  • the patient also connects his patient line to the CAPD- connector 4 using conventional aseptic techniques.
  • the patient line leads from the CAPD-connector to a catheter inserted in the peritoneal cavity of the patient.
  • the patient line com- prises a clamp (not shown on the drawings) .
  • the patient opens the clamp on his patient line to thereby establish fluid communication between his peritoneal cavity and the drain bag 2 via delivery tube 7, Y-connector 3 and drain tube 6.
  • the spent fluid from the peritoneal cavity is transferred to the drain bag via gravity forces.
  • the patient moves clamp 10 from the supply tube 5 and attaches it to the drain tube 6 to establish fluid communication between the supply bag 1 and the peritoneal cavity.
  • a separate clamp 11 on drain tube 6 is closed while clamp 10 on supply tube 5 is opened.
  • Sterile supply solution in supply bag 1 is transferred to the patient's peritoneal cavity by gravity forces to install a fresh dialysis solution.
  • the above described procedure is a normal CAPD procedure performed 4-5 times per day and normally takes about 30 minutes per exchange.
  • the solution provided in supply bag 1 has a certain compo- sition suitable for peritoneal dialysis.
  • the PD solution comprises an osmotic agent, a buffer and further electrolytes.
  • the osmotic agent is often glucose or dextrose but several other osmotic agents have been suggested and some of them are used, like icodextrin.
  • the buffer is sodium lactate although sodium bicarbonate has been investigated in clinical trials during the last years.
  • the further electrolytes are sodium chloride, magnesium chloride and calcium chloride. Further substances may be included in the peritoneal dialysis solution like amino acids and medicines such as insulin as is well known in the art.
  • the supply solution and the entire CAPD set are sterilised after manufacturing, before storage and use, in an autoclave process.
  • the set is introduced in an autoclave and heated to a temperature of approximately 121°C and kept there for approxi- mately 20 minutes.
  • the GAMBROSOL PD solution provided by Gambro AB has the following composition: sodium 132 mmol/1, calcium 1.75 or 1.35 mmol/1, magnesium 0.25 mmol/1, chloride 96 mmol/1, lactate 40 mmol/1, glucose 15, 25 or 40 g/1, and hydrochloric acid to obtain a pH of 5.5.
  • the volume of the supply solution is normally 2 litres, but may vary between 0.5 and 5 litres.
  • the low pH of the supply solution is necessary to decrease carameliza- tion and other breakdown of the glucose during sterilisation and storage.
  • An alternative supply bag, which may be used in the CAPD set according to Fig. 1, is shown in Fig. 2.
  • the supply bag is in the nature of a multi-compartment bag having an electrolyte compartment 21 and at least one osmotic agent compartment 22, whereby Fig. 2 shows two osmotic agent compartments 22 and 23.
  • This type of supply bag is disclosed in US patent 5 536 469 issued to Gambro AB.
  • the osmotic agent in this case glucose or glucose polymer
  • a separate compartment By dividing the osmotic agent compartment in two compartments as shown in Fig. 2 as disclosed in WO 97/05851 and WO 97/05852, a single supply bag having options for three different final concentrations of glucose may be provided.
  • the contents of US-A-5 536 469, WO 97/05851 and WO 97/05852 are incorporated herein by reference.
  • the pH in the multi-compartment bag, in the final prepared solution to be infused into the patient may be between 6.0 and 6.5.
  • lower concentrations of glucose degradation products are obtained in the Fig. 2 embodiment resulting in a more physiological solution and possibly reduced AGE formation during peritoneal dialysis. This is described in WO 97/30694, applicant Gambro AB, the contents of which is incorporated herein by reference.
  • the operation of the supply bag according to Fig. 2 is the following.
  • the supply bag is sterilised with the osmotic agent separated in compartments 22 and 23 and the rest of the PD solution in compartment 21.
  • break pin 24 associated with compartment 22 is broken to allow the glucose solution in compartment 22 to flow into the electrolyte compartment 21 to mix with the electrolyte solution and form a glucose concentration of 1.5%.
  • frangible pin 25 associated with compartment 23 is broken to transfer the glucose in compartment 23 to the electrolyte compartment 21, thereby to provide a glucose concentration of 2.5%.
  • both break pins 24 and 25 are broken to transfer all glucose in both compartments 22 and 23 to the electrolyte compartment 21 thereby to provide a glucose concentration of 4.0%.
  • the amount of glucose and the concentration thereof in compartment 22 and 23 are adjusted to provide the above mentioned concentrations in the final mixed solution before the solution is delivered to the patient. Even the pH of 6.0 to 6.5 obtained in the embodiment shown in Fig. 2 might be considered too low for being provided to the peritoneal cavity. There are research indicating that a physiological pH of 7.1 to 7.4 would be preferred. Such a pH can not be provided with the conventional lactate buffer. Experiments have been performed to replace the lactate buffer wholly or partially with sodium bicarbonate.
  • bicarbonate is used as a buffer, it should nor- mally be provided in a concentration of 35 to 40 mM in the final solution. Some patients may obtain too much buffer and get alkalosis if 40 mM are used, and therefore two or three different concentrations have to be provided.
  • the sum of the two buffers should be between 35 to 40 mM, for example 25 mM bicarbonate and 15 mM lactate.
  • the bicarbonate concentration should exceed 2.0 mM.
  • the bicarbonate concentration exceeds 15 mM, there is risk for calcium carbonate precipitation, specifically at long time storage. Therefore, the bicar- bonate concentration should not exceed 15 mM at a calcium concentration below 2.5 mM.
  • the risk for calcium carbonate precipitation may be reduced by separating the calcium ions from the bicarbonate buffer during autoclaving and storage. This may be done by including the calcium ions in the osmotic agent compartments 22 and 23 and including the bicarbonate buffer in the electrolyte compartment 21. Further research has revealed that a calcium neutral PD solution may be provided by providing a calcium concentration which is proportional to the glucose concentra- tion as reported in an article entitled "Should dialysate calcium be valid in proportion to the amount of ultrafiltration in peritoneal dialysis dwells? Directions from a computer simulation", published by Bengt Rippe and Lars Levin September 1998 in "Peritoneal Dialysis International", Vol. 18, p. 474- 477, no. 5., September 1998.
  • Fig. 3 discloses the supply bag 30 intended to be used in a CAPD set according to Fig. 1 or in another convenient manner.
  • Supply bag 30 comprises an electrolyte compartment 31, a first osmotic agent compartment 32 and a second osmotic agent compartment 33, connected to the electrolyte compartment 31 via frangible pins 34 and 35. So far the supply bag 30 agrees with supply bag 20 of Fig. 2. Moreover, a powder compartment 36 is provided, located between the first and the second osmotic agent compartments and connected to the electrolyte compartment 31 via a breakable seal 37. Seal 37 may be opened by pulling in tabs 38,39 attached to the supply bag 30 close to the breakable seal 37. By pulling tabs 38, 39, a sufficient force is exerted for severing seal 37 and opening the powder compartment 36 to connection with electrolyte compartment 31.
  • the powder compartment 36 comprises sodium bicarbonate powder, which upon breaking of seal 37 falls down in the large electrolyte compartment 31 and mixes with the solution therein to be dissolved. Solution in electrolyte compartment 31 may also flow into powder compartment 36 to dissolve any remaining powder which has not fallen down into compartment 31. Full dissolution of all bicarbonate powder is thereby obtained.
  • the amount of bicarbonate powder in compartment 36 is chosen to obtain the desired final bicarbonate concentration in electrolyte compartment 31.
  • the final concentration in electrolyte compartment 31 may be 35 to 40 mM, if only bicarbonate is used as a buffer, or from 2 to 35 mM, if a combination of bicarbonate and lactate is used as buffer.
  • the range of bicarbonate in the final prepared PD solution is from 2 to 15 mM.
  • frangible pins 34 and 35 are operated to introduce glucose in the electrolyte compartment 31 as desired.
  • osmotic agent compartment may be provided, for example by the exclusion of the second osmotic agent compartment 33.
  • osmotic agent compartments may be provided to increase the variation of glucose.
  • bicarbonate powder compartments may also be provided to provide a selection of bicarbonate concentrations in the final solution.
  • Bicarbonate powder can not be sterilised in the normal autoclave procedure used for PD solutions. A dry powder needs to be heated to much higher temperatures to obtain sterilisation. However, bicarbonate powder will decompose if heated to such a high temperature.
  • this problem is solved by first providing bicarbonate in powder compartment 36, sealing it and exposing the supply bag 30 for gamma radiation for a time sufficient for obtaining a sterile bicarbonate powder in compartment 36. Then, compartments 31, 32 and 33 are filled with solution and sealed, and the final product is inserted in an autoclave for sterilising the fluids.
  • the bicarbonate powder When the bicarbonate powder is exposed to gamma irradiation sufficient to obtain sterilisation, it becomes pink. However, during the following autoclaving 121°C during 20 minutes, the powder substantially retains it's original white colour, as described in EP 424 667, issued to Gambro AB . The colour of the powder is substantially restored to white but it still maintains a slight pink colour.
  • analysis has shown that no harmful components are formed when the powder is dissolved in an electrolyte solution after gamma irradiation and autoclaving. It is known that bicarbonate powder is difficult to dissolve. Therefore the powder is provided in small particles, which are faster to dissolve.
  • FIG. 4 discloses a supply bag 40 comprising an electrolyte compartment 41, a first osmotic agent compartment 42, a second osmotic agent compartment 43, frangible pins 44 and 45, similar to the embodiments shown in Figs. 2 and 3.
  • a powder compartment 46 comprising bicarbonate powder.
  • a dissolution compartment 47 is formed between the upper portion of the first and second osmotic agent compartments 42 and 43 .
  • Powder compartment 46 forms a connection between dissolution compartment 47 and electrolyte compartment 41.
  • Tabs 48 and 49 are provided for separating breakable seals, whereby a first breakable seal 50 is arranged between powder compartment 46 and electrolyte compartment 41 and a second breakable seal 51 is arranged between powder compartment 46 and dissolution compartment 47.
  • the bicarbonate powder is arranged in a powder pouch 52 attached inside powder compartment 46.
  • the breakable seals 50 and 51 are broken in that the tabs 48 and 49 are pulled.
  • a gentle pressure is exerted on electrolyte compartment 41 to press fluid through powder compartment 46 into dissolution compartment 47, thereby passing the powder in the powder pouch 52 to dissolve the bicarbonate powder comprised therein.
  • the powder pouch 52 comprises a net or web having meshes of a size which prevents passage of bicarbonate powder particles.
  • dissolution compartment 47 When dissolution compartment 47 is full of electrolyte solution including some dissolved bicarbonate, the pressure on electrolyte compartment 41 is removed and the solution is allowed to pass back through powder compartment 46 by gravity to thereby further dissolve bicarbonate powder in pouch 52. This procedure is repeated until all powder in pouch 52 is dissolved, which can be inspected visually. Normally, two fills of dissolution compartment 47 is sufficient to dissolve all powder in pouch 52 at least for bicarbonate concentrations below 15 mM.
  • electrolyte compartment 41 comprises calcium and that solution is passed into contact with powder bicarbonate in compartment 46, there is a risk for precipitation of calcium carbonate due to high local concentration of bicarbonate or carbonate.
  • electrolyte compartment 41 comprises calcium and that solution is passed into contact with powder bicarbonate in compartment 46, there is a risk for precipitation of calcium carbonate due to high local concentration of bicarbonate or carbonate.
  • calcium in osmotic agent compartments 42 and 43 this risk is avoided.
  • Calcium is mixed into the final solution when all bicarbonate powder has been dissolved and diluted, whereby the risk for calcium bicarbonate precipitation is completely avoided.
  • FIG. 5 A third embodiment of the invention is shown on Fig. 5, which has the same general layout as Fig. 4, but in which the powder pouch 52 is replaced by a powder cartridge 66.
  • supply bag 60 comprises an electrolyte compartment 61, osmotic agent compartments 62 and 63, frangible pins 64 and 65, powder compartment 66, dissolution compartment 67 and powder cartridge 70.
  • Powder cartridge 70 comprises frangible pins 68 and 69, opened to dissolution compartment 67 and electrolyte compartment 61, respectively.
  • Powder cartridge 70 is attached in powder compartment 66 in order to prevent fluid communication between dissolution compartment 67 and electrolyte compartment 61. No breakable seals are necessary in this embodi- ment .
  • the arrangement is similar to the second embodiment in Fig. 4.
  • Frangible pins 68 and 69 are broken so that the fluid communication is opened between electrolyte compartment 61 and dissolution compartment 67.
  • a gentle pressure on electrolyte compartment 61 causes passage of fluid through powder cartridge 40 into dissolution compartment 67.
  • Relief of the pressure on electrolyte compartment 61 means that solution in dissolution compartment 67 passes back through powder cartridge 70 into the electrolyte compartment 61 whereby the powder bicarbonate in cartridge 70 is dissolved.
  • cartridge 70 may be manufactured as a separate unit sealed by frangible pins 68 and 69 and sterilised by gamma irradiation or any other known method.
  • the sealed cartridge may be inserted in the supply bag blank 60 and solutions are filled in compartment 61, 62 and 63. Then, the bag is sealed and transferred to the autoclave equipment for autoclaving.
  • exposure of the PVC supply bag blank 61 for gamma irradiation is avoided.
  • the risk, that bicarbonate powder particles contaminate the seal area close the breakable seals 50, 51 and 37 is avoided.
  • Fig. 6 is a cross sectional view of a powder cartridge 80 suitable for the supply bag 60 according to Fig. 5.
  • Cartridge 80 comprises frangible pins 81, 82 extending from opposing end walls of the cartridge.
  • the cartridge is generally cylindrical or oval and is tapered adjacent both ends.
  • the cartridge may be partially or completely filled with bicarbonate powder depending on the desired concentration and the size of the cartridge.
  • Fig. 7 discloses another embodiment of the cartridge 90 suitable for use in the supply bag 60 of Fig. 5.
  • Cartridge 90 comprises internal flanges forming elongated flow paths for fluid passing through the cartridge to thereby decrease dissolution time.
  • a fourth embodiment of the invention is shown in Fig. 8.
  • the supply bag 100 comprises an electrolyte compartment 101, osmotic agent compartments 102, 103 and frangible pins 104, 105.
  • a dissolution compartment 107 is arranged below electrolyte compartment 101 between compartment 101 and the peritoneal dialysis solution outlet to supply tube 108.
  • a powder compartment 106 is arranged, comprising bicarbonate powder, in the nature of a pouch as described in connection with Fig. 4 or as a powder cartridge as described in connection with Fig. 5.
  • the dissolution of the bicarbonate powder may be performed by a cycler in an automatic manner instead of by a gentle pressure applied manually, when the supply bag is used in connection with a cycler, for example cycler PD 101 or PD 200 manufactured by Gambro AB and described in WO 95/20985, applicant Gambro AB, the contents of which is incorporated herein by reference.
  • the cycler comprises a heater bag connected to the supply bag 100 via supply tube 108. In operation, a suction is exerted from the heater bag (not shown on the drawings) via supply tube 108 to dissolution compartment 107 in Fig. 8.
  • frangible pins 110, 111 in cartridge 109 When frangible pins 110, 111 in cartridge 109 are broken, the pressure exerted by the cycler to dissolution compartment 107 results in a transfer of fluid from electrolyte compartment 101 to dissolution compartment 107 whereby the powder in cartridge 109 is dissolved. After a while the cycler exerts a pressure in supply tube 108 thereby to push or press the electrolyte solution in the solution compartment 107 back into electrolyte compartment 101 through cartridge 109 whereby further powder is dissolved. This procedure may be repeated by the machine as many times as necessary without human involvement. Finally, frangible pins 104 and/or 105 are broken to provide the desired glucose and calcium into electrolyte compartment 101.
  • Fig. 9 discloses a fifth embodiment of the invention.
  • the supply bag 120 comprises an electrolyte compartment 121, two osmotic agent compartments 122 and 123, and frangible pins 124, 125.
  • a powder compartment 126 comprises an insert 127, for example of the type shown in Fig. 6 or 7.
  • the powder compartment is arranged between the electrolyte compartment 121 and a supply tube 128, so that the PD fluid must pass through the insert to be able to reach the patient.
  • the supply bag is used together with a cycler as described above, with reference to Fig. 8, to dissolve all powder in the insert or cartridge.
  • the supply bag may also be used without a cycler for direct infusion into the peritoneal cavity of a patient.
  • insert 127 and the powder therein may be arranged to dissolve the powder bicarbonate in a slow manner, such as by slow release encapsulation, in order to avoid local high bicarbonate concentrations. Since the fluid is anyhow mixed in the peritoneal cavity, the exact dosage is not critical, specifically if low concentrations of bicarbonate is considered.
  • compositions may be provided in the different compartments according to the present invention.
  • An electrolyte compartment comprising 1900 ml and having the following composition: sodium chloride 130-140 mM, sodium lactate 20-38 mM.
  • a first osmotic agent compartment comprising 60 ml and having the following composition, glucose 50%, calcium chloride 33 mM, magnesium chloride 8 mM, sodium chloride 130-140 mM.
  • a second osmotic agent compartment comprising 100 ml and having the following composition: glucose 50%, calcium chloride 33 mM, magnesium chloride 8 mM, sodium chloride 130-140 mM.
  • a powder compartment comprising 0.33-6.7 g of powder bicarbonate. This amount of bicarbonate powder may be comprised in a cartridge having a volume of 10 ml or less.
  • the supply bag according to the invention can be used in other applications, such as a supply bag for hemodialysis or replacement solutions in connection with hemodialysis, hemodiafiltration or hemofiltration, specifically for acute hemofiltration or home dialysis.
  • the supply bag according to the invention can also be used for other medical solutions, such as nutritional solutions or infusion solutions comprising bicarbonate and optionally glucose or amino acids, or infusion solutions in connection with plasmapheresis .
  • the invention has been described by reference to a preferred embodiment. The skilled person will appreciated that many variations within the scope of the invention are possible. Other combinations than those given on the drawings are possible of the different features of each embodiment. The scope of the invention is, therefore, only limited by the following claims.

Abstract

L'invention porte sur un procédé et une poche distributrice de solution médicale, par exemple pour dialyse péritonéale. Ladite poche comporte un compartiment (31) rempli d'une solution d'électrolyte et un compartiment (36) rempli de poudre de bicarbonate. La poche est stérilisée ainsi que ses contenus. Peu avant l'utilisation on ouvre le compartiment (36) pour permettre au bicarbonate de se dissoudre dans la solution d'électrolyte. On prévoira de préférence en outre au moins un compartiment rempli d'un agent osmotique (32, 33), normalement du glucose.
PCT/SE1999/000482 1999-03-25 1999-03-25 Procede et poche distributrice WO2000057833A1 (fr)

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Application Number Priority Date Filing Date Title
PCT/SE1999/000482 WO2000057833A1 (fr) 1999-03-25 1999-03-25 Procede et poche distributrice
AU33512/99A AU3351299A (en) 1999-03-25 1999-03-25 Method and supply bag for providing a medical solution

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/SE1999/000482 WO2000057833A1 (fr) 1999-03-25 1999-03-25 Procede et poche distributrice

Publications (1)

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WO2000057833A1 true WO2000057833A1 (fr) 2000-10-05

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EP1038552A3 (fr) * 1999-03-22 2003-04-02 Fresenius Medical Care Deutschland GmbH Solution, en particulier une solution de hemodialyse ou de dialyse peritoneale, ainsi que son procédé de fabrication
WO2003053497A1 (fr) * 2001-12-20 2003-07-03 Fresenius Medical Care Deutschland Gmbh Receptacle contenant au moins deux matieres solides et son utilisation
FR2859625A1 (fr) * 2003-09-11 2005-03-18 Christiane Cinqualbre Contenant souple pour la preparation extemporanee et l'administration d'un produit liquide notamment un solute a usage de medicament
US20110257124A1 (en) * 2010-03-19 2011-10-20 Fresenius Medical Care Deutschland Gmbh Esterified Polysaccharide Osmotics
EP2484333A1 (fr) * 2011-02-03 2012-08-08 Fresenius Medical Care Deutschland GmbH Système pour la préparation d'un liquide médical et procédé de préparation de liquide médical
WO2012104405A1 (fr) * 2011-02-03 2012-08-09 Fresenius Medical Care Deutschland Gmbh Système de préparation d'un fluide médical et procédé de préparation d'un fluide médical
WO2012139753A1 (fr) * 2011-04-14 2012-10-18 Fresenius Medical Care Deutschland Gmbh Récipient à plusieurs chambres pour la production de solutions médicales
EP2537541A1 (fr) * 2011-06-23 2012-12-26 Metpro AB Récipient et raccord pour l'administration d'une solution médicale
US8343129B2 (en) 2006-06-15 2013-01-01 Metpro Ab Container, system and method for providing a solution
CN103656765A (zh) * 2012-09-11 2014-03-26 陈维勇 一种液体收集测量袋
US20140224737A1 (en) * 2010-03-19 2014-08-14 Fresenius Medical Care Deutschland Gmbh Molecularly imprinted polymers for eliminating metabolites
EP2765971A4 (fr) * 2011-10-11 2015-06-17 Soinial Ab Poche et procédé pour l'administration intraveineuse ou intracorporelle de solution médicale à un patient
EP3222306A1 (fr) * 2012-03-23 2017-09-27 NxStage Medical, Inc. Systèmes et dispositifs de dialyse péritonéale
US9861733B2 (en) 2012-03-23 2018-01-09 Nxstage Medical Inc. Peritoneal dialysis systems, devices, and methods
US9907897B2 (en) 2011-03-23 2018-03-06 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods
US10022299B2 (en) 2011-08-11 2018-07-17 Fresenius Medical Care Deutschland Gmbh Container for dialysis
WO2018130617A1 (fr) * 2017-01-11 2018-07-19 Fresenius Medical Care Deutschland Gmbh Procédé et dispositif de réalisation de solutions prêtes à l'emploi pour la dialyse péritonéale
US11207454B2 (en) 2018-02-28 2021-12-28 Nxstage Medical, Inc. Fluid preparation and treatment devices methods and systems

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WO1994025084A1 (fr) * 1993-04-23 1994-11-10 Baxter International Inc. Procede pour fabriquer et conserver des solutions stables de bicarbonate
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WO1997005852A1 (fr) * 1995-08-08 1997-02-20 Gambro Ab Sac destine a contenir une solution medicale sterile et procede de melange d'une solution medicale sterile

Cited By (44)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1038552A3 (fr) * 1999-03-22 2003-04-02 Fresenius Medical Care Deutschland GmbH Solution, en particulier une solution de hemodialyse ou de dialyse peritoneale, ainsi que son procédé de fabrication
US6689393B1 (en) 1999-03-22 2004-02-10 Fresenius Medical Care Deutschland Solution, in particular for hemodialysis or peritoneal dialysis and a method of preparing same
WO2003053497A1 (fr) * 2001-12-20 2003-07-03 Fresenius Medical Care Deutschland Gmbh Receptacle contenant au moins deux matieres solides et son utilisation
US7311886B2 (en) 2001-12-20 2007-12-25 Fresenius Medical Care Duetschland Gmbh Container containing at least two solid materials, and use thereof
FR2859625A1 (fr) * 2003-09-11 2005-03-18 Christiane Cinqualbre Contenant souple pour la preparation extemporanee et l'administration d'un produit liquide notamment un solute a usage de medicament
WO2005025482A1 (fr) * 2003-09-11 2005-03-24 Christiane Cinqualbre Contenant souple pour l’administration ou la preparation extemporanee et l’administration d’un produit liquide notamment un solute a usage de medicament
US10226561B2 (en) 2006-06-15 2019-03-12 Metpro Ab Container, system and method for providing a solution
EP3025738A1 (fr) 2006-06-15 2016-06-01 Metpro AB Contenant, système et méthode pour obtenir une solution
US9254357B2 (en) 2006-06-15 2016-02-09 Metpro Ab Container, system and method for providing a solution
US8343129B2 (en) 2006-06-15 2013-01-01 Metpro Ab Container, system and method for providing a solution
US9649325B2 (en) * 2010-03-19 2017-05-16 Fresenius Medical Care Deutschland Gmbh Esterified polysaccharide osmotics
US20110257124A1 (en) * 2010-03-19 2011-10-20 Fresenius Medical Care Deutschland Gmbh Esterified Polysaccharide Osmotics
US20140224737A1 (en) * 2010-03-19 2014-08-14 Fresenius Medical Care Deutschland Gmbh Molecularly imprinted polymers for eliminating metabolites
WO2012104405A1 (fr) * 2011-02-03 2012-08-09 Fresenius Medical Care Deutschland Gmbh Système de préparation d'un fluide médical et procédé de préparation d'un fluide médical
EP2484333A1 (fr) * 2011-02-03 2012-08-08 Fresenius Medical Care Deutschland GmbH Système pour la préparation d'un liquide médical et procédé de préparation de liquide médical
US10688235B2 (en) 2011-03-23 2020-06-23 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods
US11224684B2 (en) 2011-03-23 2022-01-18 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods
US11433170B2 (en) 2011-03-23 2022-09-06 Nxstage Medical, Inc. Dialysis systems, devices, and methods
US10610630B2 (en) 2011-03-23 2020-04-07 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods
US11690941B2 (en) 2011-03-23 2023-07-04 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods
US11433169B2 (en) 2011-03-23 2022-09-06 Nxstage Medical, Inc. Dialysis systems, devices, and methods
US10688234B2 (en) 2011-03-23 2020-06-23 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods
US10603424B2 (en) 2011-03-23 2020-03-31 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods
US11135348B2 (en) 2011-03-23 2021-10-05 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods
US9907897B2 (en) 2011-03-23 2018-03-06 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods
US10898630B2 (en) 2011-03-23 2021-01-26 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods
US11717601B2 (en) 2011-03-23 2023-08-08 Nxstage Medical, Inc. Dialysis systems, devices, and methods
US10046100B2 (en) 2011-03-23 2018-08-14 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods
WO2012139753A1 (fr) * 2011-04-14 2012-10-18 Fresenius Medical Care Deutschland Gmbh Récipient à plusieurs chambres pour la production de solutions médicales
US9132220B2 (en) 2011-04-14 2015-09-15 Fresenius Medical Care Deutschland Gmbh Multichamber container for preparing medicinal solutions
AU2012242238B2 (en) * 2011-04-14 2016-05-19 Fresenius Medical Care Deutschland Gmbh Multi-chamber container for producing medical solutions
WO2012175753A1 (fr) * 2011-06-23 2012-12-27 Metpro Ab Récipient et raccord destinés à fournir une solution médicale
US9539175B2 (en) 2011-06-23 2017-01-10 Metpro Ab Container and connector for providing a medical solution
EP2537541A1 (fr) * 2011-06-23 2012-12-26 Metpro AB Récipient et raccord pour l'administration d'une solution médicale
US10022299B2 (en) 2011-08-11 2018-07-17 Fresenius Medical Care Deutschland Gmbh Container for dialysis
EP2765971A4 (fr) * 2011-10-11 2015-06-17 Soinial Ab Poche et procédé pour l'administration intraveineuse ou intracorporelle de solution médicale à un patient
US9861733B2 (en) 2012-03-23 2018-01-09 Nxstage Medical Inc. Peritoneal dialysis systems, devices, and methods
EP3222306A1 (fr) * 2012-03-23 2017-09-27 NxStage Medical, Inc. Systèmes et dispositifs de dialyse péritonéale
CN103656765A (zh) * 2012-09-11 2014-03-26 陈维勇 一种液体收集测量袋
WO2018130617A1 (fr) * 2017-01-11 2018-07-19 Fresenius Medical Care Deutschland Gmbh Procédé et dispositif de réalisation de solutions prêtes à l'emploi pour la dialyse péritonéale
US11911547B2 (en) 2017-01-11 2024-02-27 Fresenius Medical Care Deutschland Gmbh Apparatus and method for manufacturing ready-to-use solutions for peritoneal dialysis
US11207454B2 (en) 2018-02-28 2021-12-28 Nxstage Medical, Inc. Fluid preparation and treatment devices methods and systems
US11364328B2 (en) 2018-02-28 2022-06-21 Nxstage Medical, Inc. Fluid preparation and treatment devices methods and systems
US11872337B2 (en) 2018-02-28 2024-01-16 Nxstage Medical, Inc. Fluid preparation and treatment devices methods and systems

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