Classifications

• • 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
• • 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
• • 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
  • 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
• • 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
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B32—LAYERED PRODUCTS
  • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
  • B32B27/00—Layered products comprising a layer of synthetic resin
  • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
  • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
  • Y10T156/10—Methods of surface bonding and/or assembly therefor
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T428/00—Stock material or miscellaneous articles
  • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
  • Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]

Definitions

• Disposable bag comprising a multilayer film
• the present invention relates to a disposable bag for holding a liquid comprising a multilayer film, and a device comprising a support mold for the disposable bag according to the invention, in which the disposable bag is arranged.
• the present invention relates to a method for producing the disposable bag.
• Hemodialysis machines are known in various designs.
• the mass transfer between the blood and the dialysis fluid takes place in a dialyzer having a first flow path for the blood and a second flow path for the dialysis fluid, wherein both flow paths are separated by a semipermeable membrane.
• the first flow path is part of an extracorporeal blood circulation with a supply line and a return line for the blood and, if necessary, a blood flow supporting pump.
• the second flow path is connected to means for supplying and discharging the dialysis fluid.
• Containers known from the prior art hemodialysis often consist of glass, the other
• hemodialysis machines are characterized by a relatively simple construction.
• the disadvantage is that the glass container is relatively expensive to manufacture.
• the required before dialysis treatment disinfection of the glass container proves to be disadvantageous, since often a quick reuse of the device is required. Therefore, it would be desirable to provide a hemodialysis machine in which the device can continue to operate during the required disinfection of the container containing the dialysis fluids.
• US 4,767,526 proposes a dialysis machine in which a container tank in which the
• Dialysis fluid is provided, lined with a bag that is discarded after use. This has the advantage that the container tank after removal of the bag quickly available again, and the container tank does not have to be disinfected per se.
• EP 1 235 601 B1 describes a bag for dialysate preparation in a tank. To bring this bag into the container one uses a special folding mechanism, from which the bag is unfolded from a handy format to the bag.
• WO 83/02061 describes a bag made of PVC (polyvinyl chloride) with several chambers for peritoneal dialysis. This bag is for the separate storage of dialysis solution components, which are separate are used and should be mixed when administered to the patient. A disadvantage of this bag is that it consists of PVC.
• dialysis bags have drainage or supply openings. In the event of incorrect folding or crumpling of the bag due to rapid introduction into the tank container, folds in the bag may also form in such a way that the essential openings are partially or completely closed.
• Another problem of the prior art disposable pouches is their poor stability, especially when they need to accommodate large volumes, which are particularly important to the present invention. This is due in particular to the fact that the weight or the pressure, which loads on the welds increases strongly with increase of the filling quantity.
• Another disadvantage of the known bag is that due to their size, a high material usage is required, which in turn brings a high volume of waste with it.
• Dialysis fluid is suitable to provide, which does not require the time-consuming disinfection of the tank of the dialysis machine, a safe, fast and wrinkle-free handling when introducing the disposable bag into the tank of the dialysis machine in
• a disposable bag from a multilayer film for receiving a liquid, wherein the multilayer film in the longitudinal direction of the extrusion of the film an elongation at break of 250% to 850%, preferably 400% to 800%, more preferably 500% to 750% and am most preferably 600% to 700%, and in the transverse direction of the extrusion of the film from 300% to 1050%, preferably 450% to 1000%, more preferably 600% to 900% and most preferably 700% to 800%.
• elongation at break or elongation at break is meant the percentage ratio of the change in length ⁇ L (at break) to the initial length. It expresses the ability of a material to follow changes in shape without cracking. The elongation at break is measured in a tensile test according to DIN 53455.
• a great ability to change the length in the longitudinal direction of the extrusion of the film in the above range has the advantage according to the invention that the bag, while being filled or deflated with dialysate (spent or fresh), undergoes a volume change without it exceeding the stated upper limits Cracks forms.
• This has the further advantage that in the unfilled state only a small amount of material is required, but nevertheless there is a large volume in the filled state. As a result, a product can be provided that brings only a small volume of waste with it. This is especially under
• Disposable bag is understood to mean any article which makes it possible to absorb a liquid, a solid and / or a gas for a certain period of time.
• a disposable bag in the context of the present invention means any article which is suitable for at least one use in the intended application.
• the multilayer film is understood a film consisting of two or more layers of different or the same material, which are adhesively bonded together. It is preferred in the context of the present invention for the multilayer film to be composed of 2 to 10 layers, with a construction of 2 to 5 layers being more preferred and a construction of 3 or 4 layers being particularly preferred.
• the multilayer film may be prepared according to any method known to those skilled in the art as suitable for the purpose of the present invention.
• the multilayer film of the disposable bag according to the invention in the longitudinal direction extrusion of the film has a tensile strength of 300 N / mm 2 to 350 N / mm 2 , preferably 310 N / mm 2 to 340 N / mm 2 and more preferably 320 N / mm 2 to 330 N / mm 2 , and in the transverse direction, the extrusion of the film from 220 N / mm 2 to 270 N / mm 2 , preferably 230 N / mm 2 to 260 N / mm 2, and more preferably 240 N / mm 2 to 250 kp / cm 2 .
• Tear strength is the tensile stress exerted on an article at the moment of tearing. The tensile strength is measured in the tensile test in accordance with DIN 53455. A tensile strength below the lower limit mentioned above is disadvantageous since otherwise the bag will break early due to overstretching. Above the stated upper limit of the bag is very tear-resistant, but not sufficiently stretchable.
• the multilayer film of the disposable bag according to the invention preferably has a transverse stretch number ⁇ in the rubbery state of 0.45 to 0.55, more preferably 0.47 to 0.53 and most preferably 0.49 to 0.51.
• the transverse strain number also called the Poisson number, is defined as the ratio of the relative change in thickness ⁇ d / d to the relative change in length ⁇ l / 1 when an external force or stress is applied.
• Another embodiment of the invention is a disposable bag in which the multi-layer film can be stretched by up to 500% by a force of preferably 45N to 60N, more preferably 48N to 62N, most preferably 52N to 58N.
• a weight corresponding to a certain force in N is uniformly attached to a 15 mm wide sheet and the change in length is measured.
• a high extensibility has the advantage that the bag in the unfilled state has a small size and thus is easy to handle.
• the material requirement is low due to the strong extensibility of the material.
• a simpler production and packaging of the material is made possible.
• a particularly preferred embodiment of the present invention is also a disposable bag in which the ratio of the outer surface of the disposable bag in the maximum-filled state to the outer surface in the unfilled state is in the range of preferably 5/1 greater than 2/1, more preferably greater than 5/1 ,
• Typical upper limits are about 8/1 to 12/1 e.g. 10/1 or 9/1. Higher ratios, however, are provided according to the invention.
• outer surface is meant the area of the bag that is filled with the environment (air) as well unfilled state can come into contact.
• maximum filled state is described by the maximum size of the bag, at which the bag is just barely cracking and consequently not yet cracking.
• Unfilled condition means the condition of the bag in which the interior of the bag is substantially not filled with matter of any kind, that is, occupies substantially no space.
• the property of surface increase as a function of the filling quantity ensures that the multilayer film of the bag is always under pressure when filled, so that as the filling increases this pressure increases and any wrinkles in the multilayer film, which may be in the unfilled state, disappear more and more.
• This has the advantage according to the invention that a wrinkle-free introduction of the disposable bag into a tank container of a medical apparatus, in particular a dialysis machine, is ensured. Thus, the complete removal of the liquid from the bag is guaranteed.
• volume in the state in which the multilayer film is free of strain preferably ⁇ 3/1, preferably ⁇ 5/1.
• Typical non-limiting ranges are 3/1 to 12/1, more preferably 5/1 to 11/1, even more preferably 7/1 to 10/1, and most preferably 8/1 to 9/1.
• volume of volume in the state in which the multilayer film is stretch-free is understood to mean the volume which can be filled into the bag without any stretching of the multilayer film taking place.
• the disposable bag of the above embodiments preferably has a maximum filled capacity in the range of 30 L to 120 L, more preferably 40 L to 110 L, even more preferably 50 L to 100 L, more preferably 60 L is up to 90 L and most preferably 70 L to 80 L.
• the disposable bag of the present invention may contain one chamber or more than one (multiple) chambers. By the term “several” is meant the presence of at least two compartments, however, the disposable bag may have as many compartments as would appear appropriate to the skilled person for the particular application.
• the disposable bag preferably contains 1 to 10 chambers, more preferably 2 to 6 chambers, more preferably 2 to 4 and most preferably 2 or 3 chambers.
• the disposable bag contains only one chamber, two disposable bags can also be used in the dialysis machine, one for the provision of fresh dialysate and one in which spent dialysate is recycled. However, if the disposable bag contains multiple chambers, it is preferred to use one of the chambers for providing fresh dialysate and a chamber for collecting used dialysate.
• Such a use of the disposable bag (s) according to the invention has the advantage that a separation of fresh and consumed filling material is possible and thus no cross-contamination occurs.
• there must be no water drain at the point of use since the use of a bag with several chambers or two or more bags with a chamber, the spent dialysate can be collected in a chamber.
• the individual chambers are preferably also made of parts of the multilayer film, as defined in more detail below.
• the individual chambers can each have one or more supply and discharge line (s), it being preferred that - especially in the case of a disposable bag with 2 chambers - has at least one chamber via a supply line and the other chamber via a drain line.
• each individual chamber may also have a supply and discharge line.
• the supply and discharge line (s) can be firmly welded to the disposable bag or fixed or detachable connected via a sealing system.
• the hose connections to the disposable bag may be conventional fittings. It is crucial that the disposable bag can be quickly connected to the supply and discharge line (s) or removable again for replacing the disposable bag. But it is also possible that the supply or discharge line system is formed integrally with the disposable bag.
• the multilayer film of a disposable bag comprises a layer of the type (A) containing a plurality of components, wherein one of the components is selected from the group consisting of styrene-isoprene block copolymers, styrene-ethylene-butylene-styrene block copolymers, styrene-ethylene-butylene block copolymers, styrene Ethylene-propylene block copolymers and mixtures thereof, and another component is selected from the group consisting of polyethylene and a random copolymer comprising ethylene units.
• the further component in the layer of type (A) is a random copolymer composed of ethylene and octene units.
• the proportion of one component in the layer of type (A) can be in the range of 35% to 99.99%, preferably 50% to 99.9%, more preferably 55% to 99%, even more preferably 60% to 95%. and most preferably 60% to 90%, based on the total composition of the layer of the type (A).
• the further component in the layer of type (A) may thus range from 0.01% to 65%, more preferably from 0.1% to 50%, more preferably from 1% to 45%, even more preferably from 5 to 40% and most preferably from 10% to 40%, based on the total composition of the layer of type (A).
• the multilayer film further comprises one or more layers of type (B), which independently contain a plurality of components, wherein one of the components is selected from the group consisting of styrene-ethylene-butylene
• Block copolymers SEB
• SEBS styrene-ethylene-butylene-styrene block copolymers
• SEP styrene-ethylene-propylene block copolymers
• SIS styrene-isoprene-styrene block copolymers
• the further component in the layer of type (B) is composed of a random copolymer comprising propylene and ethylene units.
• Sheets with a layer of type (B) are advantageous in terms of their high extensibility.
• the proportion of one component in the layer of type (B) can be in the range of 35% to 99.99%, preferably 50% to 99.9%, more preferably 55% to 99%, even more preferably 60% to 95% and most preferably 60% to 90%, based on the total composition of the layer of type (A).
• the further component in the layer of type (B) may thus range from 0.01% to 65%, more preferably from 0.1% to 50%, more preferably from 1% to 45%, even more preferably from 5 to 40% and most preferably from 10% to 40%, based on the total composition of the layer of type (B).
• the multilayer film is preferably constructed from a laminate of 3 layers.
• the middle layer is preferably a layer of the above-mentioned type (A).
• the two outer layers surrounding the layer of type (A) are preferably layers of type (B).
• These outer layers of the type (B) may have the same or different composition (s).
• polyethylene is understood to mean a thermoplastic polymer produced by polymerization of ethylene and having the simplified chain structural formula (C 2 H 2 ) n .
• a copolymer comprising ethylene units is one by copolymerization of ethylene Polyethylene and a copolymer comprising ethylene units belong to the group of polyolefins.
• the so-called "further olefin” is preferably an alpha-olefin comprising from 3 to 20 carbon atoms, and examples of any other olefin include propylene, butene, pentene, hexene, heptene and octene, with octene being particularly preferred.
• polypropylene is understood to mean a thermoplastic polymer produced by the polymerization of propylene and having the simplified chain structural formula (C 3 Hg) n
• a copolymer comprising propylene units is one obtained by copolymerization of propylene with Polypropylene and a copolymer comprising propylene units belong to the group of polyolefins.
• the so-called "further olefin” is preferably an ⁇ -olefin comprising 2 or 4 to 20 carbon atoms, respectively, and examples of any further olefins are ethylene, butene, pentene, Hexene, heptene and octene, with ethylene being particularly preferred.
• PE-HD weakly branched polymer chains, therefore high density between 0.94 g / cm 3 and 0.97 g / cm 3 , ("HD” stands for "high density”).
• PE-LD highly branched polymer chains, hence low density between 0.915 g / cm 3 and 0.935 g / cm 3 , ("LD” stands for "low density”).
• LLDPE linear low-density polyethylene whose polymer molecule has only short branches. These branches are formed by copolymerization of
• PE-HMW high molecular weight polyethylene.
• the polymer chains are longer than in PE-HD, PE-LD or PE-LLD, the average molecular weight is 500 kg / mol to 1000 kg / mol.
• PE-UHMW ultra-high molecular weight polyethylene with an average molecular weight of up to 6000 kg / mol and one
• the above-mentioned copolymers comprising at least ethylene and propylene units are preferably random copolymers.
• a random copolymer is a copolymer in which the at least two different monomer units of which the polymer is composed are copolymerized in a random order.
• the above-mentioned block copolymers are understood as meaning polymers in which the monomers are not randomly incorporated in the chain, but in which homopolymeric chain segments are linked to one another. They are a copolymer and polymer blend agent and offer the potential to improve polymers without changing the monomer composition.
• block polymers include the following: mixed block copolymers of ethylene, propylene, alpha-olefins or isoprene and styrene (so-called olefinic styrenic block copolymers) and diene-styrenic block copolymers, e.g. SEBS, SEPS, SBS, SEB, SEP and SIS etc.
• elastomeric styrene-butadiene or styrene-isoprene block copolymers preferably with a diene content of more than 50% by weight, and, for example, resinous styrene.
• Butadiene and styrene-isoprene block copolymers preferably with a diene content of less than 50 wt .-%, based on the total weight of the copolymer can be used.
• styrene-diene block copolymers having a diene content of over 50 wt .-% so their proportion in the mixture is preferably between 20 wt .-% and 40 wt .-%, but may, depending on requirements, also higher or lower.
• Styrene-diene styrene-diene block copolymers containing styrene containing more than 50% by weight, in particular those containing from about 65% by weight to 95% by weight of styrene should preferably be present in an amount of from 40% by weight to 60% by weight. be contained in the molding composition of the invention.
• the disposable film be free of polyvinyl chloride.
• the multilayer film is composed of 3 layers, the first outer layer comprising 60% by weight of styrene-ethylene-butylene-styrene (SEBS) copolymer and 40% by weight of polypropylene-ethylene random copolymer middle layer 60 wt .-% styrene-ethylene-butylene-styrene block copolymer and 40 wt .-% random polyethylene-octene copolymer and the second outer layer 60 wt .-% styrene-ethylene-butylene-styrene block copolymer (SEBS ) and 40% by weight polypropylene-ethylene random copolymer.
• SEBS styrene-ethylene-butylene-styrene
• the multilayer film is heat sterilizable. It is possible that only one layer of the multilayer film is heat sterilizable, but it can also be heat sterilized two or more or even all layers of the multilayer film. It is particularly preferred that at least the layer is heat sterilizable, which forms the inside of the disposable bag according to the invention.
• the multilayer film during and after treatment with steam at a temperature in the range of 100 to 140 0 C, preferably 110 to 130 0 C and a pressure of 1 to 2 bar both their outer shape and maintains its mechanical and physico-chemical properties.
• the thickness of the multilayer film is preferably in a range from 1 ⁇ m to 1000 ⁇ m, more preferably from 5 ⁇ m to 800 ⁇ m, more preferably from 8 ⁇ m to 500 ⁇ m, and most preferably from 10 ⁇ m to 150 ⁇ m. It is possible that the individual layers of the multilayer film each have the same thickness or different thicknesses. In the case of a 3- or multi-layer multilayer film, it is particularly preferred for the two layers forming the outside to have a thickness of ⁇ 40 ⁇ m, preferably ⁇ 20 ⁇ m.
• the inner layer of a 3- or multi-layered film may preferably have a thickness of ⁇ 500 ⁇ m, more preferably 300 ⁇ m, and most preferably 100 ⁇ m, whereby good stability and elasticity are achieved. As a result, a high flexibility and load life is achieved.
• at least one layer of the multilayer film further comprises additives and impurities, such as e.g. Catalyst residues, in a content below 5000 ppm and below 200 ppm.
• the respective outer layers are formed by heat-sterilisable layers. This results in the advantage that in the heat sterilization neither adhesion of the inner sides of the disposable bag nor sticking of the outer sides of the disposable bag to other components can occur.
• At least one layer of the multilayer film is sealable, preferably heat-sealable.
• the Sealing temperature is preferably in the range of 160 0 C to 230 0 C, more preferably in the range of 18O 0 C to 21O 0 C.
• the multilayer film is biocompatible and particularly preferably hemocompatible.
• the multilayer film is a transparent film.
• the multilayer film is preferably free from
• Lubricants plasticizers, antiblocking agents, antistatic agents and fillers.
• the present invention relates to a device comprising a support apparatus in which a disposable bag according to the invention is arranged.
• the support apparatus is preferably adapted to support / stabilize the disposable bag at the locations where welds are likely to break first. This solves the problem of quickly and safely removing the disposable bag from the tank container and absorbing the force at the weak points of the bag after filling. In this way, it is thus possible to introduce and take out an elastic container without the above-mentioned problems such as wrinkling, professionally and quickly in a tank container.
• the support apparatus for receiving the disposable bag according to the invention preferably comprises a holding device, which is preferably such that the disposable bag can be attached thereto in the filled as well as unfilled state. Further, the support apparatus must be large enough to accommodate the disposable bag in an extended volume corresponding to the application, ie at least the have the above-mentioned maximum capacity of the disposable bag.
• the support apparatus preferably has a receiving unit designed as a shaping shell.
• the forming shell has a central cylindrical contact surface, which is followed by an outwardly curved upper contact surface and an outwardly curved lower contact surface.
• the shapes of the preferably vessel-like support apparatus are not subject to any limitation. It can be used very differently curved and differently shaped interiors of the support apparatus, if this is necessary for technical reasons or aesthetic reasons. A secure storage of dialysate is ensured by the elastic bag in any case.
• the advantage of such a shaping shell is that the pressure of a disposable bag possibly in it in the filled state is well absorbed. That For medical treatment, such as hemodialysis or peritoneal dialysis, the disposable bag is inserted into the shaping bowl, which is preferably present in the supporting apparatus.
• the bag according to the invention attaches to the wall of the molded article
• the disposable bag according to the invention is provided at the upper and / or lower end with a holding device, preferably in the form of a holding rail, via which it can be fastened in the apparatus.
• the disposable bag can thus be introduced into the apparatus and also removed again. It is particularly preferred that the supply and / or discharge line are attached via the holding device.
• the holding device can either be firmly connected to the disposable bag or removably attached.
• the holding device is likewise an article which is disposed of together with the disposable bag according to the invention.
• Disposable bag is mounted in a holding device or even that several of the disposable bags according to the invention are mounted in each case a holding device in an apparatus.
• the present invention relates to the use of the disposable bag according to the invention or the invention Device for use in an apparatus for carrying out a medical treatment.
• the apparatus mentioned in the last section is an apparatus for performing hemodialysis or peritoneal dialysis, i.
• the medical treatment is hemodialysis or peritoneal dialysis.
• the present invention relates to a method for
• Production of the disposable bag according to the invention comprises the following steps:
• the method according to the invention also comprises the step of dividing the multilayer film into several parts. This step is preferably carried out before step b) of the method defined above.
• the inventive method for producing a multilayer film according to the invention is characterized in that the multilayer film is preferably produced by co-extrusion.
• the starting materials are mixed, compounded and granulated, for example, before they are preferably co-extruded on a water-blown blown film line. It is preferred that the layers of the multilayer film are coextruded in direct contact with each other.
• a protective film produced by coextrusion is applied to one or both sides of the multilayer film. This protective film (s) is / are easily removed from the multilayer film according to the invention and can be removed without leaving any residue.
• the multilayer film can also be produced in a separate extrusion process, a calendering process or in a film casting process.
• the coextrusion dressing can be smoothed to produce a smooth surface immediately after extrusion.
• the multilayer film may also be smoothed by any other method known to those skilled in the art.
• Fig. 1 a disposable bag according to the invention with 2 chambers, each with a feed and a drain line
• FIG. 2 shows a disposable bag according to the invention with a holding device in the form of a retaining rail.
• 3 shows a disposable bag according to the invention with 2
• Holding devices in the form of retaining rails are provided.
• FIG. 6 shows a force [N] / elongation [%] diagram of the comparative film 2.
• FIG. 1 shows a disposable bag (1) according to the invention.
• the disposable bag (1) according to the invention is shown in side view.
• the disposable bag is through a
• Dividing wall / separating film (4) divided into 2 chambers, each with a feed or discharge line ((2), (3)) are provided.
• Figure 2 shows the disposable bag according to the invention of Figure 1, which is also on the top, on which the supply and discharge line ((2), (3)) are mounted, equipped with a holding device (5) in the form of a retaining rail.
• the holding rail (5) can also serve to fix the supply and discharge line ((2), (3)).
• Figure 3 shows the disposable bag according to the invention of Figure 2, which is also also equipped on the bottom with a holding device (6) in the form of a retaining rail.
• FIG. 4 shows a force [N] / elongation [%] diagram of the multilayer film of a disposable bag according to the invention.
• FIGS. 5 and 6 show a force [N] / elongation [%] diagram of comparative films 1 (FIG. 5) and 2 (FIG. 6).
• the patterns 1-3 mentioned in the embodiments 1 to 5 have the following structure:
• Sample 1 is a three-layer film with the following structure: Compound A: 10 ⁇ m Compound B: 130 ⁇ m Compound A: 10 ⁇ m
• the outer layers, as well as the characteristic layer of the multilayer film according to Example 1, contains a styrene-ethylene-propylene (SEP) block copolymer.
• SEP styrene-ethylene-propylene
• Compound B 100 parts SEP (Septon 2005;
• Compound A 100 parts SEB (molecular weight ⁇ 120,000 g / mol) 70 parts PP-R Co (PP 23M 10cs264; Fa.Rexene)
• Compound B 100 parts of SEB (molecular weight ⁇ 120,000 g / mol) 100 parts of PE copolymer (Engage, DOW) (p ⁇ 0.9 g / cm 3 )
• SEB styrene-ethylene-butylene block copolymer
• PP-R Co polypropylene random copolymer
• PE polyethylene
• the film according to sample 3 is a commercially available film from Nissho. It is a monofilm with the following composition: 54% SEB 23-35% PP 5-23% EAA.
• SEB styrene-ethylene-butylene block copolymer
• EAA ethylene-acrylic acid polymer
• empty bags produced from corresponding films were heat sterilized at a temperature of 121 ° C. for 40 minutes.
• the inner surfaces of the bag showed no measurable when using the multilayer film according to sample 1 Sticking or sticking.
• the bag inner surfaces were glued using the multi-layer film according to pattern 2 after the heat sterilization and could only be solved by a hydrostatic pressure of about 320 mm WS (water column) within about 90 seconds to a length of 10 cm.
• pattern 3 the inner surfaces of the pouches were clearly bonded to one another after heat sterilization and did not completely detach from one another even after a ten-minute pressurization with water at 300 mm Hg.
• the multilayer film was fixed between two housing halves. At the bottom of the case, the film was flat, while on the top of the case a 25 ml dome.
• Table 1 shows the gas permeability of the samples 1, 2 and 3 for O 2 and CO 2 , wherein the O 2 gas permeability according to ASTM D-3985, DIN 53380 was determined.
• Example 2 shows that the inventive multilayer film in the heat sterilization is not measurably susceptible to sticking, which is due to the fact that the outer layers of at least 55% heat sterilizable styrene-ethylene-propylene block copolymer having an average molecular weight ⁇ 120 000 g / mol and less than 45% polypropylene.
• a tensile test was carried out with a sample of the multilayer film of the disposable bag according to the invention. Samples with a width of 15 mm and a thickness of 120 ⁇ m were tested. The test was carried out with samples that were transverse to the direction of extrusion (CD) as well as longitudinal to
• Table 2 Results of the tensile test
• the tensile test was carried out in accordance with DIN EN 527 1-3 at a feed rate of 1 mm / min.
• Construction ca.200 microns thickness

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• Health & Medical Sciences (AREA)
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• Bag Frames (AREA)
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