EP1755521B1 - Medizinische Flüssigkeitsbeutelanordnung und Verfahren zur Bereitstellung, Anordnung und Behandlung von medizinischen Flüssigkeiten - Google Patents

Medizinische Flüssigkeitsbeutelanordnung und Verfahren zur Bereitstellung, Anordnung und Behandlung von medizinischen Flüssigkeiten Download PDF

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Publication number
EP1755521B1
EP1755521B1 EP05746693.0A EP05746693A EP1755521B1 EP 1755521 B1 EP1755521 B1 EP 1755521B1 EP 05746693 A EP05746693 A EP 05746693A EP 1755521 B1 EP1755521 B1 EP 1755521B1
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EP
European Patent Office
Prior art keywords
fluid
compartment
fluid bag
bag
special cover
Prior art date
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Application number
EP05746693.0A
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English (en)
French (fr)
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EP1755521A1 (de
Inventor
Ola Carlsson
Massimo Bormetti
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Fresenius Medical Care Deutschland GmbH
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Fresenius Medical Care Deutschland GmbH
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Publication date
Priority claimed from SE0401585A external-priority patent/SE0401585D0/xx
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP1755521A1 publication Critical patent/EP1755521A1/de
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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
    • 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

Definitions

  • the present invention concerns a medical fluid bag arrangement which comprises a fluid bag with at least a first and a second compartment, which are separated from each other such that different fluids can be arranged in said compartments.
  • the first compartment contains a first fluid
  • the second compartment contains a second fluid, which is different from the first fluid.
  • At least the second fluid has such a composition that it runs the risk of being degraded during the sterilisation of the fluid bag.
  • the invention also concerns a method of providing, arranging and treating medical fluids.
  • EP 0 596 497 B1 describes a bag for containing at least two separate substances which are to be mixed with each other.
  • the bag comprises two chambers: a larger chamber and a smaller chamber.
  • the chambers are separated from each other by a separating section. This separating section can be opened in order to mix the two substances.
  • the smaller chamber is positioned over the larger chamber with the separating section between the chambers. The reason for this arrangement is to prevent that the two substances are accidentally mixed with each other.
  • the document also mentions that sterilisation of the bag can be performed before or after the bag is folded.
  • EP 0 972 506 A2 describes a flexible bag for containing at least two separate substances to be mixed for medical use.
  • the bag has two chambers.
  • the bag is fitted with an outer covering.
  • the covering can either be applied to the bag when the bag is fully extended or it can be applied to the bag when the bag has been folded.
  • the document also describes that the bag is sterilised in an autoclave.
  • FIG. 1 schematically shows an example of a fluid bag that is used for peritoneal dialysis.
  • This schematic illustration is similar to the fluid bag GambrosolTM Trio sold by Gambro AB, Sweden.
  • the fluid bag comprises three different compartments: 11, 12, 13.
  • Inlet ports 111, 112, 113 are provided for allowing the compartments 11, 12, 13 to be filled with fluids.
  • An exit port 23 is also provided. The dialysis fluid can exit through this port 23 in order to be delivered to a patient.
  • the contents of the compartments 11, 12, 13 can be mixed with each other.
  • the bag includes frangible pins 15, 17 which enable a user to open a passage between the compartments 12 and 13 and the compartment 11.
  • frangible pins 15, 17 other kinds of means for providing a passage between the compartments can be used.
  • Such means can for example be provided in the form of socalled peel seals.
  • the reason for providing the fluid bag with different compartments is that different fluids cannot be stored for a long time in a mixed state.
  • a dialysis fluid is an aqueous solution that comprises an osmotic agent such as a carbohydrate, for example glucose, glucose polymers or the like, electrolytes, for example sodium, potassium, calcium, magnesium, and a buffer source in the form of organic acid salts such as sodium lactate, sodium bicarbonate or sodium pyruvate.
  • the osmotic agent may for example be included in the compartment 12 or in both the compartments 12 and 13. It is for example possible to include osmotic agents of different concentrations and/or of different kinds, in the compartments 12 and 13.
  • compartments 12 and 13 contain different volumes of the same osmotic agent. This makes it possible to choose the concentration of the osmotic agent in the final dialysis solution by mixing the contents of one or both of the compartments 12 and 13 with the content of the compartment 11. Electrolytes may also be included in the compartments 12 and 13.
  • Fig. 2 shows a schematic view in the direction II-II indicated in Fig. 1.
  • Fig. 2 also schematically illustrates a protective coating 19.
  • the fluid bag is also often delivered together with a drain bag 21, which can be provided inside the protective coating 19.
  • the drain bag 21 is used to collect used dialysis fluid from a patient.
  • tubing 20 inside the protective coating 19 normally also tubing 20 (only indicated in Fig. 2 ) is provided inside the protective coating 19 .
  • the tubing 20 includes a tube connected to an exit port 23 (see Fig. 1 ) and a tube connected to the drain bag 21. These tubes often merge together to a common tube to be connected to the patient.
  • the fluid When a medical fluid is exposed to heat during sterilisation, the fluid may, depending on which fluid it is, be degraded. This degradation may be different for different fluids.
  • the chemical composition of the medical fluid may be influenced such that the fluid does not work as well as intended for its medical purpose. The degradation may also result in the formation of toxic products in the fluid.
  • a PD fluid usually includes an osmotic agent.
  • This osmotic agent may for example be glucose.
  • the sterilisation has to be performed such that the patient, who is to receive the fluid, does not run the risk of being infected and, on the other hand, care has to be taken not to sterilise the fluid in such a way that the composition of the fluid changes by e.g. degradation.
  • the sterilisation has to be performed such that official requirements are fulfilled.
  • the sterilisation dose has to be sufficiently high such that the fluids in all compartments are sterilised to the required degree.
  • a sufficiently high sterilisation dose such that the fluid in the compartment 11 is sterilised to a required degree.
  • the smaller compartments 12, 13 thereby risk being exposed to an unnecessary high sterilisation dose, i.e. too much energy is transferred to the fluids in the smaller compartments during sterilisation. If for example one or both of the smaller compartments 12, 13 include glucose, a degradation of the substance in these compartments 12, 13 may occur.
  • toxic glucose degradation products such as 3-deoxyglucosone, acetaldehyde, formaldehyde, 3,4-dideoxyglucosone-3-ene and methylglyoxal can be formed.
  • Such degradation products are cytotoxic and are able to promote the formation of advanced glycation end products known to accelerate arteriosclerosis. It is thus very important to make sure that as little degradation products as possible are formed during the sterilisation.
  • An object of the present invention is to further reduce the risk for the formation of degradation products when sterilising medical fluid bags of the kind described in the first paragraph above.
  • An object is thereby to provide a medical fluid bag arrangement which is such that the formation of degradation products during sterilisation is eliminated or reduced.
  • a further object is to provide such a fluid bag arrangement which is easy and inexpensive to produce.
  • a peritoneal dialysis (PD) fluid will be discussed as an example of a medical composition.
  • the invention is also applicable to other medical fluids which risk being degraded during sterilisation when being sterilised for medical use.
  • Such fluids may for example be parenteral nutrition solutions or other sterile solutions for intravenous use, which comprise carbohydrates, proteins or peptides.
  • the whole medical fluid bag arrangment is of such a form that it is suitable to be delivered to a hospital or to a patient without removing any part of the medical fluid bag arrangement.
  • the whole medical fluid bag arrangement can thus go through the whole sterilisation process without removing any party of the medical fluid bag arrangment. Thereafter, the whole medical fluid bag arrangment (possibly after have been put in a cardboard box or other suitable external package) is ready to be delivered to a hospital or directly to a patient's home.
  • present invention can also be combined with the teachings of the above mentioned documents WO 97/05852 A1 and WO 93/09820 A1 .
  • present invention does however not necessarily have to be combined with the teaching of these documents.
  • the fluid bag is arranged folded such that the second compartment is folded back such that it lays over at least part of said first compartment.
  • the special cover is arranged at least over the folded second compartment.
  • the special cover can be arranged only over the folded second compartment.
  • the special cover is arranged over both the second compartment and the first compartment and also over possible further compartments that are included in the fluid bag.
  • the fluid bag is arranged non-folded such that the second compartment is positioned beside the first compartment and wherein the special cover is positioned such that the second compartment completely or to a large extent is insulated by the special cover but such that the first compartment is not insulated at all by the special cover or is insulated to a substantially lesser degree than the second compartment.
  • the special cover can be arranged on one or on both sides of the second compartment.
  • the special cover can for example be arranged to extend around (be wrapped around) the second compartment.
  • the volume of the first fluid in said first compartment is a least two times the volume of the second fluid in said second compartment.
  • the volume of the first fluid may also be essentially larger than this, for example at least 5 times or at least 10 times or at least 15 times the volume of the second fluid in the second compartment.
  • the volume of the first fluid is essentially larger than the volume of the second fluid there is a high risk that the second fluid receives an unnecessary high sterilisation dose.
  • this can be avoided with the present invention even if the volume of the first fluid is much larger than the volume of the second fluid.
  • the fluid bag can comprise a third compartment which contains a third fluid which is different from at least said first fluid.
  • the third fluid may of course also be different from the second fluid.
  • the third compartment may suitably be folded together with the second compartment over the first compartment.
  • the special cover may according to a preferred embodiment be positioned both over the folded second compartment and over the folded third compartment. Thereby, also the risk for degradation of the third fluid can be reduced.
  • the fluid bag is arranged with means which enables a user to open a passage in said fluid bag between at least said first and second compartments, such that in said fluid bag, the second fluid can be mixed with at least said first fluid.
  • Such means can for example constitute frangible pins or peel seals as described above.
  • the content of the fluid bag is such that the fluid bag contains a dialysis fluid for use in a process of hemodialysis, hemodiafiltration, hemofiltration or peritoneal dialysis, and/or a replacement fluid, suitable to be delivered to a patient in order to replace the ultrafiltrate that is withdrawn from a patient in a process of hemodialysis, hemofiltration, hemodiafiltration or peritoneal dialysis, or that the content of the fluid bag is such that the fluid bag contains a concentrate for such a dialysis or replacement fluid.
  • the fluid bag contains a dialysis fluid for peritoneal dialysis or a concentrate for such a dialysis fluid for peritoneal dialysis.
  • the invention is particularly useful in connection with such fluids, but, as mentioned above, the fluid bag may also comprise other sterile medical fluids.
  • said special cover comprises a drain bag that is to be used for receiving a fluid drained off from a patient in a process of peritoneal dialysis.
  • a drain bag is often used in connection with continuous ambulatory peritoneal dialysis (CAPD). It has therefore been found to be particularly advantageous and practical if the drain bag is used as the special cover.
  • the fluid bag arrangement can also comprise tubing connected to said drain bag and to said fluid bag. In order to avoid contamination when the fluid bag and the drain bag are used, it is advantageous to provide these bags with the necessary tubing before the bags are delivered to the user.
  • the fluid bag arrangement also comprises a protective coating which surrounds the whole fluid bag.
  • a protective coating which surrounds the whole fluid bag.
  • said special cover comprises a first portion of said protective coating that is thicker than the remaining portion of the protective coating or that is made of a material with a lower heat conductivity than the remaining portion of the protective coating. According to this embodiment, the special cover thus constitutes a portion of the protective coating. It may therefore not be necessary to have another separate special cover, in addition to the protective coating, in this case.
  • the protective coating can comprise a first sheet and a second sheet which have been bonded to each other to form said protective coating, wherein one of said first and second sheets constitutes said first portion. If the protective coating comprises two sheets, one sheet can thus be made of a thicker material, or of a material with a lower heat conductivity, in order to fulfil the function of the special cover.
  • the special cover comprises a drain bag or another separate spe.cial cover
  • said protective coating preferably surrounds both the whole fluid bag and the whole drain bag or said another separate special cover.
  • the protective coating thereby ensures that the drain bag or another separate special cover is maintained in position. Furthermore, in case the fluid bag is folded, it can be ensured that the fluid bag is not accidentally unfolded. Furthermore, the protective coating protects the fluid bag and the drain bag or other separate special cover from being contaminated.
  • the object of the invention is also achieved by a method of providing, arranging and treating medical fluids according to claim 14.
  • the method is performed such that the special cover remains in the position defined above during the whole sterilisation process, i.e. during the whole sterilisation time necessary to sterilise the whole medical fluid bag to a sufficient degree.
  • the special cover is not removed during the sterilisation process.
  • the special cover is such that it is suited to remain in the position that it has during the sterilisation process also after the sterilisation process has been completed.
  • the special cover is such that it is suited to remain in the position that it has during the sterilisation process all the time until the sterilised medical fluid bag has been delivered to a hospital or to a patient.
  • said special cover is positioned and said fluid bag, if folded, is folded such that the fluids in the different compartments during the sterilisation step are sterilised to a sufficient degree while preventing that the fluid in some compartment receives too much energy during the sterilisation, such that by said method unnecessary degradation of the fluids in the fluid bag during the sterilisation is prevented.
  • Fig. 1 schematically shows a fluid bag according to the prior art
  • Fig. 2 shows a fluid bag arrangement according to the prior art.
  • Embodiments of a medical fluid bag arrangement according to the invention will now be described primarily with reference to Fig. 4, 5, 6, 7 and 8 .
  • the arrangement according to the invention includes a fluid bag.
  • This fluid bag can be of a known kind, for example of the kind described in connection with Fig. 1 .
  • the fluid bag is preferably formed by a flexible plastic material such as PVC or another plastic material, or by a combination of different plastic materials.
  • Fig. 3 illustrates another example of a fluid bag that can be used in the arrangement according to the invention.
  • the fluid bag according to Fig. 3 is similar to the fluid bag of Fig. 1 .
  • the fluid bag according to Fig. 3 differs from the fluid bag of Fig. 1 in that the first compartment 11 does not extend between the second compartment 12 and the third compartment 13. Instead, an inlet port 111 is in this case arranged in the lower part of the fluid bag as indicated in the figure.
  • the fluid bag of Fig. 3 also differs from the fluid bag of Fig. 1 in that no frangible pins 15 and 17 are used. Instead, the fluid bag according to Fig.
  • the fluid bag is preferably formed by a flexible plastic material or by a combination of different plastic materials, for example including polypropene and polyamides.
  • a fluid bag that forms part of the arrangement according to the invention may of course be designed in different manners than what is shown in Fig. 1 and Fig. 3 .
  • the fluid bag that forms part of the arrangement according to the invention always includes at least two compartments 11, 12.
  • the present invention can be applied to different medical fields where a fluid bag has a compartment that includes a fluid that runs the risk of being degraded during the sterilisation process.
  • the fluid bag includes a dialysis fluid for peritoneal dialysis (PD).
  • PD peritoneal dialysis
  • Such a fluid bag may for example have three compartments 11, 12, 13 as illustrated in Fig. 1 and 3 .
  • the first compartment 11 is often much larger than the second compartment 12 and the third compartment 13.
  • the first compartment 11 may include 1960 ml of fluid
  • the second compartment 12 may include 62 ml of fluid
  • the third compartment may include 103 ml of fluid.
  • the first compartment 11 can include the necessary buffer and electrolyte solution
  • the second compartment 12 and the third compartment 13 may include a glucose solution.
  • the fluids in the second compartment 12 and the third compartment 13 can be the same. This makes it possible for a user to choose a certain glucose concentration in the dialysis fluid by mixing the content of the second compartment 12 or of the third compartment 13 or of both the compartments 12 and 13 with the content of the first compartment 11.
  • the fluid bag has to be sterilised to a sufficient degree in order to prevent that the patient who receives the fluids is infected and in order to fulfil official requirements.
  • the sterilisation may for example be performed in an autoclave chamber by saturated steam under pressure.
  • the sterilisation conditions for example temperature and time, have to be selected such that a sufficient sterilisation is obtained. These conditions have to be chosen such that in particular the content of the largest compartment 11 is sufficiently sterilised. As explained above, this means that the smaller second and third compartments 12, 13 may be exposed to an unnecessary high sterilisation dose.
  • the fluids in the smaller compartments may thus be heated too quickly and/or maintained at an elevated temperature for an unnecessary long time. In other words: too much energy is transferred to the fluids in the smaller compartments during the sterilisation. This may lead to the formation of unwanted or even toxic degradation products in these smaller compartments 12, 13.
  • Fig. 4 illustrates schematically a first embodiment of a fluid bag arrangement according to the invention.
  • This arrangement includes a fluid bag, for example of the kind described above.
  • the fluid bag is folded such that the second compartment 12 is folded back such that it lays over at least part of the first compartment 11.
  • the bag can for example be folded along the hatched line 29 shown in Fig. 3 . This means that both the second compartment 12 and the third compartment 13 will be folded such that they lay over the first compartment 11.
  • the fluid bag is provided with frangible pins, like in Fig. 1 , it may be advantageous to fold the fluid bag somewhat lower as seen in Fig. 1 , i. e. below the frangible pins 15, 17.
  • a special cover 31 is arranged at least over one side of the second fluid compartment 12 (and in this case also over the third fluid compartment 13).
  • the special cover 31 is however not arranged around the whole fluid bag.
  • the special cover 31 may constitute a drain bag.
  • the special cover 31 is a separate cover that is used only for the purpose of reducing the sterilisation dose which the smaller compartments 12, 13 receive.
  • the special cover 31 is arranged such that the second compartment 12 (and according to this embodiment also the third compartment 13) does not receive too much energy during sterilisation, while permitting that the fluids in the different compartments, i. e. in particular in the compartment 11, are sterilised to a sufficient degree.
  • Fig. 4 illustrates that the special cover 31 is arranged substantially only above the second 12 and third 13 compartments.
  • the special cover 31 can for example be a folded drain bag.
  • Fig. 5 shows that the special cover 31, for example in the form of a drain bag, is arranged to extend both over the smaller compartments 12, 13 and over the larger compartment 11.
  • Fig. 6 shows that the special cover 31 is arranged both over and below the folded smaller compartments 12 and 13.
  • the special cover 31 may in this case for example be a folded drain bag.
  • the special cover 31 is formed of a material that will not adhere to the fluid bag during sterilisation.
  • the fluid bag is made of PVC
  • the special cover 31 is preferably not made of PVC.
  • the fluid bag arrangement may also include a separate sheet 33 (see Fig. 4, 5 and 7 ) which is arranged between the folded portion of the bag and the compartment 11 in order to prevent that the folded portion will be caused to adhere to the compartment 11 during sterilisation.
  • a separate sheet 33 can also be made to provide an insulating effect, for example by being sufficiently thick.
  • the separate sheet 33 provides such an insulating effect. If for example the sterilisation is performed such that the heating is effected from below the fluid bag, it can (if the fluid bag is positioned as shown in Fig 4,5 and 7 ) be advantageous if the separate sheet 33 has such insulating properties.
  • the fluid bag arrangement according to the invention also preferably includes a protective coating 35 which surrounds the whole fluid bag.
  • a protective coating is well known to a person skilled in the art.
  • the protective coating 35 is preferably made of a material that will not adhere to the parts arranged inside the protective coating 35 during sterilisation.
  • Fig. 7 shows an embodiment of the arrangement according to the invention that includes a particular kind of protective coating 35.
  • the protective coating 35 here consists of an upper sheet 37 and a lower sheet 39 that are bonded together in order to provide a sealed protective coating 35 surrounding the whole fluid bag.
  • the upper sheet 37 is made of a special material that is different from the material of the lower sheet 39.
  • the upper sheet 37 can be formed of a thicker material or may be made of a material with a lower heat conductivity. This can for example be achieved if the upper sheet 37 includes more layers than the lower sheet 39.
  • the upper sheet 37 therefore, according to this embodiment, constitutes the special cover 31 that fulfils the function of reducing the risk for the formation of unwanted degradation products in the smaller compartments 12 and 13 of the fluid bag. It should be noted that it is of course also possible that an additional special cover 31, for example in the form of a drain bag, is arranged inside the protective coating 35 also in the embodiment according to Fig. 7 .
  • Fig. 8 schematically shows an alternative embodiment of a fluid bag arrangement according to the invention.
  • the fluid bag is not folded.
  • the special cover 31 is arranged to surround the smaller compartments 12, 13 but the larger compartment 11.
  • the special cover 31 is thus positioned such that the second 12 and third 13 compartments completely or to a large extent are insulated by the special cover 31 but such that the first compartment 11 is not insulated at all by the special cover 31 (or, alternatively, is insulated to a substantially lesser degree than the smaller compartments 12,13). If this special cover 31 is designed to have sufficient insulating properties, it is possible to achieve the object of the invention without folding the bag.
  • the special cover 31 may constitute a drain bag.
  • the medical fluid bag arrangement may also comprise suitable tubing 20 attached to the fluid bag and to a possible drain bag that forms part of the arrangement.
  • Fig. 9 schematically shows a sterilisation chamber 41.
  • This sterilisation chamber 41 may constitute an autoclave. Since such an equipment is known to a person skilled in the art, it will not be disclosed in detail here.
  • the chamber 41 has a support surface 45 for the fluid bag arrangement that is to be sterilised.
  • the chamber 41 can be filled with saturated steam under pressure.
  • Fig. 10 shows a schematic flow chart of one manner of carrying out a method according to the invention.
  • a medical fluid bag comprising at least two compartments 11, 12 is provided. Fluids are provided in these compartments 11, 12.
  • the fluid bag may of course comprise more than two compartments and different medical fluids can be arranged in the different compartments.
  • the fluid bag can include fluids in the different compartments that are to be mixed with each other in order to form a PD fluid.
  • the fluid bag is folded, for example as described above.
  • a special cover 31 is then arranged over at least the folded fluid bag compartment 12.
  • the special cover 31 may constitute a drain bag that is to be used for receiving a fluid drained off from a patient in a process of peritoneal dialysis.
  • the special cover 31 may be arranged in different manners as described above.
  • a protective coating 35 is provided such that this protective coating surrounds the fluid bag and the special cover 31.
  • the fluid bag arrangement obtained in this manner is positioned in a sterilising chamber 41. Sterilisation is then performed such that the fluids in the different compartments 11, 12, 13 are sterilised to a sufficient degree while preventing that the fluid in some compartment 12, 13 receives too much energy during the sterilisation. Thereby unnecessary degradation of the fluids in the fluid bag is prevented.
  • a fluid bag similar to the one illustrated in Fig. 1 has been used.
  • the different compartments 11, 12, 13 were filled with fluids as described above in order for the bag to contain a PD fluid.
  • the fluid bag was sterilised in an autoclave.
  • the fluid bag was sterilised in a non-folded state with a drain bag positioned on top of the fluid bag (substantially as illustrated in Fig. 2 ).
  • the fluid bag was folded (similar to what is illustrated in for example Fig. 4 ) but without positioning any drain bag or other special cover on top of the fluid bag.
  • the fluid bag was folded in the same manner as in case two, but also provided with a drain bag on top of the fluid bag (similar to what is shown on Fig. 5 ).
  • the concentration of the following three degradation products in the smaller compartments 12, 13 was measured: 3-DG (3-deoxyglucosone), 5-HMF (5-hydroxymethylfurfural) and 3,4-DGE (3,4-dideoxyglucosone-3-ene). Furthermore, the F 0 -value was measured in the smaller compartments 12, 13 and in the larger compartment 11. It can be noted that the F 0 -value is a measure of the sterilisation dose. This concept is known to a person skilled in the art. The concept is explained in the literature, see for example the European Pharmacopoeia-1997, p. 288. The result of the tests is shown in the table below.
  • the concentration of degradation products is substantially reduced in the third case (i. e. a folded bag with a drain bag on top). It can also be seen that in the first two cases, the F 0 -value for the smaller compartments 12, 13 is essentially higher than for the larger compartment 11. This means that if the larger compartment 11 is to receive a sufficiently high sterilisation dose, the smaller compartments 12, 13 will receive an unnecessary high sterilisation dose. However, in the third case, the F 0 -value for the smaller compartments 12, 13 is in fact a little lower than the F 0 -value for the larger compartment 11. This means that the sterilisation conditions in this case can be chosen such that the smaller compartments 12, 13 will be sterilised to a sufficient degree. At the same time also the larger compartment 11 will be sterilised to a sufficient degree. An unnecessary high sterilisation dose in the smaller compartments 12, 13 is therefore avoided.

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  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (26)

  1. Medizinische Flüssigkeitsbeutelanordnung mit einem Flüssigkeitsbeutel mit mindestens einer ersten Kammer (11) und einer zweiten Kammer (12), die voneinander getrennt sind, so dass verschiedene Flüssigkeiten in den Kammern (11, 12) angeordnet werden können, wobei die erste Kammer (11) eine erste Flüssigkeit enthält und die zweite Kammer (12) eine zweite Flüssigkeit enthält, die von der ersten Flüssigkeit verschieden ist, wobei der Flüssigkeitsbeutel ein Konzentrat für eine Dialyseflüssigkeit zur Peritonealdialyse enthält, und wobei mindestens die zweite Flüssigkeit ein Osmosemittel enthält, das Gefahr läuft, sich zu zersetzen, wenn die zweite Flüssigkeit während der Sterilisation des Flüssigkeitsbeutels zu viel Energie erhält,
    dadurch gekennzeichnet, dass
    die Flüssigkeitsbeutelanordnung eine Spezialabdeckung (31, 37) umfasst, die dazu ausgelegt ist, in der Position, die sie während des Sterilisationsprozesses hat, auch nach Beendigung des Sterilisationsprozesses zu bleiben, und die über mindestens einer Seite der zweiten Kammer, aber nicht um den gesamten Flüssigkeitsbeutel herum angeordnet ist.
  2. Medizinische Flüssigkeitsbeutelanordnung nach Anspruch 1, wobei der Flüssigkeitsbeutel gefaltet angeordnet ist, so dass die zweite Kammer (12) zurückgefaltet wird, so dass sie über mindestens einem Teil der ersten Kammer (11) liegt.
  3. Medizinische Flüssigkeitsbeutelanordnung nach Anspruch 2, wobei die Spezialabdeckung (31, 37) mindestens über der gefalteten zweiten Kammer (12) angeordnet ist.
  4. Medizinische Flüssigkeitsbeutelanordnung nach Anspruch 1, wobei der Flüssigkeitsbeutel nichtgefaltet angeordnet ist, so dass die zweite Kammer (12) neben der ersten Kammer (11) positioniert ist, und wobei die Spezialabdeckung (31) so positioniert ist, dass die zweite Kammer (12) vollständig oder zu einem großen Teil durch die Spezialabdeckung (31) isoliert ist, aber so, dass die erste Kammer (11) überhaupt nicht durch die Spezialabdeckung (31) isoliert ist oder in wesentlich geringerem Maße isoliert ist als die zweite Kammer (12).
  5. Medizinische Flüssigkeitsbeutelanordnung nach einem der vorhergehenden Ansprüche, wobei das Volumen der ersten Flüssigkeit in der ersten Kammer (11) mindestens das Doppelte des Volumens der zweiten Flüssigkeit in der zweiten Kammer (12) beträgt.
  6. Medizinische Flüssigkeitsbeutelanordnung nach einem der vorhergehenden Ansprüche, wobei der Flüssigkeitsbeutel eine dritte Kammer (13) umfasst, die eine dritte Flüssigkeit enthält, die von mindestens der ersten Flüssigkeit verschieden ist.
  7. Medizinische Flüssigkeitsbeutelanordnung nach einem der vorhergehenden Ansprüche, wobei der Flüssigkeitsbeutel mit Mitteln (15, 17, 25, 27) angeordnet ist, die es einem Benutzer erlauben, einen Kanal in dem Flüssigkeitsbeutel zwischen mindestens der ersten Kammer (11) und der zweiten Kammer (12) zu öffnen, so dass in dem Flüssigkeitsbeutel die zweite Flüssigkeit mit mindestens der ersten Flüssigkeit gemischt werden kann.
  8. Medizinische Flüssigkeitsbeutelanordnung nach einem der vorhergehenden Ansprüche, wobei die Spezialabdeckung (31) einen Entleerungsbeutel umfasst, der zur Aufnahme einer im Verlauf einer Peritonealdialyse aus einem Patienten ausgeleiteten Flüssigkeit verwendet werden soll.
  9. Medizinische Flüssigkeitsbeutelanordnung nach Anspruch 8, wobei die Anordnung einen Schlauch (20) umfasst, der mit dem Entleerungsbeutel (31) und mit dem Flüssigkeitsbeutel verbunden ist.
  10. Medizinische Flüssigkeitsbeutelanordnung nach einem der vorhergehenden Ansprüche, umfassend einen Schutzüberzug (35), der den gesamten Flüssigkeitsbeutel umgibt.
  11. Medizinische Flüssigkeitsbeutelanordnung nach Anspruch 10, wobei die Spezialabdeckung (37) einen ersten Abschnitt (37) des Schutzüberzugs (35) umfasst, der dicker ist als der übrige Abschnitt (39) des Schutzüberzugs (35) oder der aus einem Material mit einer geringeren Wärmeleitfähigkeit als der übrige Abschnitt (39) des Schutzüberzugs (35) besteht.
  12. Medizinische Flüssigkeitsbeutelanordnung nach Anspruch 11, wobei der Schutzüberzug (35) eine erste Folie (37) und eine zweite Folie (39) umfasst, die miteinander verklebt wurden, um den Schutzüberzug (35) zu bilden, wobei die erste Folie (37) oder die zweite Folie (39) den ersten Abschnitt darstellt.
  13. Medizinische Flüssigkeitsbeutelanordnung nach einem der Ansprüche 10 bis 12, wobei die Spezialabdeckung (31) einen Entleerungsbeutel oder eine weitere separate Spezialabdeckung umfasst und wobei der Schutzüberzug (35) sowohl den gesamten Flüssigkeitsbeutel als auch den gesamten Entleerungsbeutel (31) oder die weitere separate Spezialabdeckung umgibt.
  14. Verfahren zum Bereitstellen, Anordnen und Behandeln medizinischer Flüssigkeiten, mit den folgenden Schritten:
    - Bereitstellen eines medizinischen Flüssigkeitsbeutels mit mindestens einer ersten Kammer (11) und einer zweiten Kammer (12), die voneinander getrennt sind, so dass verschiedene Flüssigkeiten in den Kammern (11, 12) angeordnet werden können; Bereitstellen einer ersten Flüssigkeit in der ersten Kammer (11) und einer zweiten Flüssigkeit in der zweiten Kammer (12), wobei die zweite Flüssigkeit von der ersten Flüssigkeit verschieden ist, wobei der Flüssigkeitsbeutel ein Konzentrat für eine Dialyseflüssigkeit zur Peritonealdialyse enthält, und wobei mindestens die zweite Flüssigkeit ein Osmosemittel enthält, das Gefahr läuft, sich zu zersetzen, wenn die zweite Flüssigkeit während der Sterilisation des Flüssigkeitsbeutels zu viel Energie erhält,
    - Anordnen einer Spezialabdeckung (31, 37) über mindestens einer Seite der zweiten Kammer (12), aber nicht um den gesamten Flüssigkeitsbeutel herum,
    - Anordnen der so erhaltenen Flüssigkeitsbeutelanordnung in einer Sterilisationskammer (41), und
    - Durchführen einer Sterilisation, so dass die Flüssigkeiten in den verschiedenen Kammern (11, 12) in ausreichendem Maße sterilisiert werden,
    wobei die Spezialabdeckung (31, 37) in der Position, die sie während des Sterilisationsvorgangs hat, auch nach Beendigung des Sterilisationsvorgangs bleibt.
  15. Verfahren nach Anspruch 14, umfassend den folgenden Schritt vor Durchführung der Sterilisation: Falten des Flüssigkeitsbeutels in einer solchen Weise, dass die zweite Kammer (12) zurückgefaltet wird, so dass sie über mindestens einem Teil der ersten Kammer (11) liegt.
  16. Verfahren nach Anspruch 15, umfassend den folgenden Schritt vor Durchführung der Sterilisation: Anordnen der Spezialabdeckung (31, 37) mindestens über der gefalteten zweiten Kammer (12).
  17. Verfahren nach Anspruch 14, umfassend die folgenden Schritte vor Durchführung der Sterilisation: Anordnen des Flüssigkeitsbeutels im nicht gefalteten Zustand, so dass die zweite Kammer (12) neben der ersten Kammer (11) positioniert ist, und Anordnen der Spezialabdeckung (31) in einer solchen Weise, dass die zweite Kammer (12) vollständig oder zu einem großen Teil durch die Spezialabdeckung (31) isoliert ist, aber so, dass die erste Kammer (11) überhaupt nicht durch die Spezialabdeckung (31) isoliert wird oder in wesentlich geringerem Maße als die zweite Kammer (12) isoliert wird.
  18. Verfahren nach einem der Ansprüche 14 bis 17, umfassend die folgenden Schritte vor Durchführung der Sterilisation: Auslegen des Flüssigkeitsbeutels und Anordnen der ersten und der zweiten Flüssigkeit so, dass das Volumen der ersten Flüssigkeit in der ersten Kammer (11) mindestens das Doppelte des Volumens der zweiten Flüssigkeit in der zweiten Kammer (12) beträgt.
  19. Verfahren nach einem der Ansprüche 14 bis 18, umfassend die folgenden Schritte vor Durchführung der Sterilisation: Bereitstellen des Flüssigkeitsbeutels in einer solchen Konstruktion, dass er auch eine dritte Kammer (13) umfasst, und Anordnen einer dritten Flüssigkeit, die von mindestens der ersten Flüssigkeit verschieden ist, in der dritten Kammer (13).
  20. Verfahren nach einem der Ansprüche 14 bis 19, umfassend den folgenden Schritt vor Durchführung der Sterilisation: Versehen des Flüssigkeitsbeutels mit Mitteln (15, 17, 25, 27), die es einem Benutzer erlauben, einen Kanal in dem Flüssigkeitsbeutel zwischen mindestens der ersten Kammer (11) und der zweiten Kammer (12) zu öffnen, so dass in dem Flüssigkeitsbeutel die zweite Flüssigkeit mit mindestens der ersten Flüssigkeit gemischt werden kann, wenn der Flüssigkeitsbeutel verwendet werden soll, nachdem er die Sterilisation durchlaufen hat.
  21. Verfahren nach einem der Ansprüche 14 bis 20, wobei die Spezialabdeckung (31) einen Entleerungsbeutel umfasst, der verwendet werden soll, um eine aus einem Patienten im Verlauf einer Peritonealdialyse ausgeleitete Flüssigkeit aufzunehmen.
  22. Verfahren nach Anspruch 21, umfassend den folgenden Schritt vor Durchführung der Sterilisation: Bereitstellen eines Schlauches (20) und Verbinden des Schlauches (20) mit dem Entleerungsbeutel (31) und mit dem Flüssigkeitsbeutel.
  23. Verfahren nach einem der Ansprüche 14 bis 22, umfassend den folgenden Schritt vor Durchführung der Sterilisation: Bereitstellen eines Schutzüberzugs (35), der den gesamten Flüssigkeitsbeutel umgibt.
  24. Verfahren nach Anspruch 23, wobei der Schutzüberzug (35) so ausgewählt ist, dass die Spezialabdeckung (37) einen ersten Abschnitt (37) des Schutzüberzugs (35) umfasst, der dicker ist als der übrige Abschnitt (39) des Schutzüberzugs (35), oder der aus einem Material mit einer geringeren Wärmeleitfähigkeit als der übrige Abschnitt (39) des Schutzüberzugs (35) besteht.
  25. Verfahren nach Anspruch 24, wobei der Schutzüberzug (35) eine erste Folie (37) und eine zweite Folie (39) umfasst, die mit einander verklebt sind, um den Schutzüberzug (35) zu bilden, wobei die erste Folie (37) oder die zweite Folie (39) den ersten Abschnitt darstellt.
  26. Verfahren nach einem der Ansprüche 23 bis 25, wobei die Spezialabdeckung (31) so gewählt ist, dass sie einen Entleerungsbeutel oder eine weitere separate Spezialabdeckung umfasst, und wobei der Schutzüberzug (35) so angeordnet ist, dass er sowohl den gesamten Flüssigkeitsbeutel als auch den gesamten Entleerungsbeutel (31) oder die weitere separate Spezialabdeckung umgibt.
EP05746693.0A 2004-06-18 2005-05-24 Medizinische Flüssigkeitsbeutelanordnung und Verfahren zur Bereitstellung, Anordnung und Behandlung von medizinischen Flüssigkeiten Active EP1755521B1 (de)

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SE0401585A SE0401585D0 (sv) 2004-06-18 2004-06-18 A medical fluid bag arrangement and a method of providing, arranging and treating medical fluids
US52178604P 2004-07-02 2004-07-02
PCT/SE2005/000776 WO2005123001A1 (en) 2004-06-18 2005-05-24 A medical fluid bag arrangement and a method of providing, arranging and treating medical fluids

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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

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US4602910A (en) * 1984-02-28 1986-07-29 Larkin Mark E Compartmented flexible solution container
US4902287A (en) * 1987-09-24 1990-02-20 Miles Inc. Sterilizable system for blood storage
IT1258699B (it) * 1992-11-06 1996-02-27 Italia Farina Sacca di contenimento di almeno due fluidi separati da miscelare.
SE510030C2 (sv) * 1995-08-08 1999-04-12 Gambro Ab Förfarande för blandning av steril medicinsk lösning samt behållare för utförande av förfarandet
SE9601348D0 (sv) * 1996-04-10 1996-04-10 Pharmacia Ab Improved containers for parenteral fluids
IT1303144B1 (it) * 1998-07-10 2000-10-30 Haemotronic Advanced Medical T Sacca flessibile per il contenimento di almeno due sostanze separateda miscelare per uso medico, e relativo metodo di fabbricazione
SE521219C2 (sv) * 1998-10-23 2003-10-14 Gambro Ab Metod och anordning för att reducera nedbrytning av värmekänsliga komponenter i medicinska substanser under värmesterilisering
ATE451903T1 (de) * 2002-04-30 2010-01-15 Otsuka Pharma Co Ltd Medizinischer mehrkammerbehälter und beutel zu seiner umhüllung

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