WO2023274967A1 - Procédé de revêtement d'un dispositif de transfert de masse ou son précurseur de produit - Google Patents

Procédé de revêtement d'un dispositif de transfert de masse ou son précurseur de produit Download PDF

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Publication number
WO2023274967A1
WO2023274967A1 PCT/EP2022/067585 EP2022067585W WO2023274967A1 WO 2023274967 A1 WO2023274967 A1 WO 2023274967A1 EP 2022067585 W EP2022067585 W EP 2022067585W WO 2023274967 A1 WO2023274967 A1 WO 2023274967A1
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WO
WIPO (PCT)
Prior art keywords
coating
coating solution
chamber area
chamber
membrane
Prior art date
Application number
PCT/EP2022/067585
Other languages
German (de)
English (en)
Inventor
Kashefi Khorasani AHMAD ALI
Original Assignee
Rheinisch-Westfälische Technische Hochschule (Rwth) Aachen Körperschaft Des Öffentlichen Rechts
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Application filed by Rheinisch-Westfälische Technische Hochschule (Rwth) Aachen Körperschaft Des Öffentlichen Rechts filed Critical Rheinisch-Westfälische Technische Hochschule (Rwth) Aachen Körperschaft Des Öffentlichen Rechts
Publication of WO2023274967A1 publication Critical patent/WO2023274967A1/fr

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D67/00—Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
    • B01D67/0081—After-treatment of organic or inorganic membranes
    • B01D67/0088—Physical treatment with compounds, e.g. swelling, coating or impregnation
    • 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
    • A61M1/1621—Constructional aspects thereof
    • 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
    • A61M1/1698—Blood oxygenators with or without heat-exchangers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
    • B01D69/12—Composite membranes; Ultra-thin membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/66—Polymers having sulfur in the main chain, with or without nitrogen, oxygen or carbon only
    • B01D71/68—Polysulfones; Polyethersulfones
    • 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
    • A61M2207/00—Methods of manufacture, assembly or production
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2323/00—Details relating to membrane preparation
    • B01D2323/04—Hydrophobization
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2323/00—Details relating to membrane preparation
    • B01D2323/66—Avoiding penetration into pores of support of further porous layer with fluid or counter-pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/70—Polymers having silicon in the main chain, with or without sulfur, nitrogen, oxygen or carbon only

Definitions

  • the invention relates to a method for coating a mass transfer device or its product precursor, in which at least one membrane, preferably a porous membrane, is arranged in a chamber, the at least one membrane dividing the chamber into a first chamber area in which a first side of the at least one membrane can be contacted by a first exchange medium and is divided into a second chamber area, in which a second side of the at least one membrane can be contacted by a second exchange medium, with a coating solution being filled into one of the two chamber areas and the side of the at least a membrane is coated, after which excess coating solution is removed from the chamber area.
  • at least one membrane preferably a porous membrane
  • the invention also relates to a blood oxygenator made by the method.
  • Mass transfer devices of the type mentioned are known in principle in the prior art. They can contain membranes of various shapes and types.
  • membranes that can be used in the invention are, for example, flat membranes, in particular those that form a flat plate in the relaxed state.
  • membranes can be used which are formed as flock fibers, in which case the flock fiber wall forms the membrane.
  • the two sides of the membrane mentioned at the outset are the outside and the inside of the fluff fiber, ie a Exchange medium can be routed along the outside of the hollow fiber and the other can be routed through its interior.
  • a Exchange medium can be routed along the outside of the hollow fiber and the other can be routed through its interior.
  • these can be assembled as a bundle or packet, eg as wound or folded in layers mats of hollow fibers.
  • a preliminary product stage can be, for example, a cylindrical, elongated housing that includes a bundle of hollow fibers that are still to be potted or have already been potted at the end regions, in particular to one another and to the inner wall of the housing. Potting is a term that is common in this area to those skilled in the art and means that sealing is effected, e.g. by gluing with a suitable agent, e.g. polyurethane or silicone.
  • the product precursor can, for example, be provided with cover elements at the open ends, e.g. to form a mass transfer device, or at least to carry out the method according to the invention, in particular in order to then subsequently form a coated mass transfer device from the coated product precursor.
  • mass transfer devices are used to exchange the substances contained in two exchange media, e.g. for the purpose of separation or targeted enrichment and/or depletion.
  • membranes are used, for example, which have a specific selectivity, in particular by which is meant that the membrane is more permeable to certain substances than to other substances.
  • membranes can be used in which the mass transfer takes place by diffusion and/or the mass transfer takes place through the pores of the membrane.
  • the invention relates to all possible types of membranes, in particular porous, preferably microporous membranes, in particular the pores of which are at least on average smaller than 1 micrometer in diameter.
  • Mass transfer devices of this type can, for example, be produced directly for use as a blood oxygenator.
  • the function of a blood oxygenator is such that blood flowing through one of the chambers of an oxygenator is enriched in oxygen and depleted in carbon dioxide, while an oxygen-rich and low-carbon gas or gas mixture flows through the other chamber, so that a partial pressure equalization occurs across the at least one membrane of the gas components takes place.
  • Such oxygenators can be used to support or replace lung function.
  • hydrophobic, in particular semipermeable, hollow fibers are usually used, the wall of which forms the membrane, the hydrophobic design preventing blood plasma from passing through the hollow fiber wall.
  • oxygenators are established in the market and must be classified as expensive.
  • the membranes of such oxygenators are made, for example, from polymethylpentene, the membrane basically having pores, i.e. being porous, but having a thin, very unstable, non-porous layer. The exchange of substances thus takes place by diffusion.
  • the permeability of silicone for oxygen and/or carbon dioxide is strongly dependent on the thickness of the silicone layer applied as a skin on the surface of the membrane/hollow fibers or as a filling in the pores of the membrane/hollow fibers.
  • the aforementioned publication does not mention any essential features for carrying out the process and does not give the person skilled in the art any information on checking the silicone coating in order to achieve layer thicknesses that would be suitable for actual use as an oxygenator.
  • a coating solution such as a silicone-containing solution
  • the coating material absorbs a coating solution, such as a silicone-containing solution, over the entire wall thickness due to capillary forces and the coating material thereby settles in the pores of the membrane and on the side of the membrane from which the coating solution is applied, accumulates in an uncontrollable thickness and practically as a result the layer thicknesses are too great for hollow fibers coated in this way to actually be usable for blood oxygenation.
  • a further object of the invention is to redesign industrially manufactured dialyzers by means of a coating in such a way that they can subsequently be used as blood oxygenators. Furthermore, it is an object to use a silicone material with a solvent for dilution as a coating solution or a coating agent comprising silicone without additional solvent as a coating solution. Agents containing silicone that are already commercially available should preferably be used.
  • coating solution thus does not imply the mandatory presence, but the possible presence of a solvent. According to the invention, this object is achieved in that the other chamber area is closed off from the outside environment before the coating solution is poured in.
  • the other chamber area is to be understood here as that which faces away from the chamber area through which the coating solution is applied.
  • a coating of the at least one membrane, such as a flat membrane or hollow fibers on the side that is assigned to the chamber area that is filled with the coating solution means at least that the coating solution is on the surface of the at least one membrane or the wall of the hollow fibers is deposited on this side as a skin.
  • the coating can additionally also be understood to mean that the pores of the hollow fibers are at least partially filled, starting from this side in the direction of the opposite other chamber region.
  • a coating of a membrane within the meaning of the invention can therefore preferably mean a deposition of coating material on the surface of the membrane and in the pores of the membrane.
  • the essential approach of the invention is based on the fact that by closing the other chamber area to the environment, a pressure equalization in the at least one membrane to be coated, preferably in the chamber containing the hollow fiber packet to be coated, in particular on the side of the other chamber area, is prevented.
  • a desired situation in particular a pressure situation or filling situation, can thus be set and/or maintained in the chamber, with which the implementation of the coating can be influenced in a targeted manner.
  • the at least one membrane can preferably be formed by a porous flat membrane or by the wall, preferably the porous wall, of a hollow fiber.
  • the invention can be used in a mass transfer device or a product preliminary stage to coat a hollow fiber bundle with a multiplicity of hollow fibers, each of which forms a membrane, preferably hydrophilic porous hollow fibers.
  • the first side and/or the second side of a membrane, e.g. flat membrane and in particular the inside of the hollow fibers, alternatively the outside or both can be coated.
  • the membrane side e.g. the hollow fiber side
  • the membrane side is preferably coated, which forms the side in contact with the blood in the application, and the inside of the hollow fiber is particularly preferably coated.
  • the invention opens up various options for controlling the coating of the at least one membrane, preferably the hollow fibers.
  • a preferred embodiment can provide for the other chamber area to be closed off from the environment by being closed directly at its fluid connections or by at least one container, in particular a container under ambient pressure, being connected to this other chamber area, preferably via the fluid connections will.
  • a container can be connected to one of the fluid connections of the chamber area and the other fluid connection is closed directly.
  • a container can also be connected to each fluid connection. Filling with the coating solution therefore only takes place after the other chamber has been closed.
  • This container or both containers together can preferably have a volume that is smaller than the volume of the chamber in which the at least one membrane, preferably the hollow fiber bundle, is arranged or is smaller than the volume of the chamber area that is not filled and attached to the the container is connected.
  • the invention forms a compliance volume through the container volume or the sum of the container volumes, which provides a volume-dependent adjustable resilience, in particular resilience to the acting capillary forces.
  • the filling depth can be controlled by the size of the connected volume.
  • the invention can also completely eliminate the at least one additionally connectable container by directly closing the fluid connections.
  • the compliance volume is the smallest possible and is formed solely by the volume of the other chamber.
  • a development can provide that the depth of the pore filling is adjusted as a function of the filling pressure in the chamber area filled with the coating solution and/or as a function of the pressure in the other chamber area.
  • the pressure in the other chamber area can therefore also be set to deviate from the ambient pressure. In this way, the filling pressure can dominate over the capillary force, which allows the filling of the pores in the membrane, preferably in the wall of the hollow fibers, to be controlled.
  • the invention can also provide for the container to be provided with a predetermined overpressure relative to the environment.
  • the resilience against the capillary forces can be set to zero and thus the pores of the membrane, preferably the hollow fibers, can be completely prevented from being filled with the coating solution until the filling pressure exceeds the pressure level in the container and the coating solution has thereby penetrated the pores of the membrane or preferably the hollow fiber wall is shifted.
  • Another preferred embodiment which can also be combined with the previous one, can provide for a vacuum to be generated in the entire chamber of the mass transfer device or a product precursor after the other chamber has been closed, after which the coating solution is poured into the chamber area to be filled will.
  • the other chamber area can be closed directly at its fluid connections or by at least one closed container being connected to at least one of the fluid connections, e.g. according to the previous embodiment.
  • the air can be pumped out via at least one fluid connection of the chamber area to be filled with the coating solution.
  • the negative pressure in the filled chamber area is then reduced, ie in particular the pressure in the filled chamber is increased.
  • the coating solution can preferably be sucked into the pores of the at least one membrane by the negative pressure that continues to exist in the other chamber region.
  • provision can preferably be made for the negative pressure to be maintained during the filling, ie in particular for a pressure increase resulting from the filling on the side of the filling in the chamber to be compensated for.
  • the filling can take place, for example, with the vacuum pump running. It can be provided that the coating solution is sucked into the chamber area to be filled by the prevailing negative pressure, in particular when the pump is running during the filling.
  • the invention can thus preferably provide that the depth of the pore filling is adjusted as a function of the pressure increase in the chamber area filled with the coating solution.
  • the invention can provide for a solvent to be filled into both chamber areas before the other chamber area is closed from the environment. It is preferably the same solvent with which the coating agent, e.g. silicone, is dissolved for the preparation of the solvent-containing coating solution.
  • the solvent can preferably be n-heptane.
  • Both chamber areas can be filled, for example, by means of perfusion of the solvent through both chamber areas and through the membrane pores in a pump circuit in which the solvent is pumped. It is sufficient to pump the solvent through only one of the two chamber areas, since it automatically penetrates through the pores of the at least one membrane, preferably the hollow fibers, into the other chamber area and fills it. This is even preferred since the air is completely expelled from the pores in this way.
  • This design preferably leads to the chamber areas and the pores of the at least one membrane, preferably the hollow fibers, which connect the two chamber areas, being filled with the solvent.
  • the coating solution is filled in, which takes place after the other chamber area has been closed, the coating solution cannot penetrate into the pores, since the pores are already occupied by the solvent.
  • the coating solution into or through the chamber area to be filled and in doing so to remove the solvent from it by the solvent being displaced by the coating solution.
  • the pores covered with solvent are not yet filled, in particular only a coating of the surface of the at least one membrane or preferably the wall areas of the hollow fibers is carried out, in particular on the first and/or second side of the at least one membrane or with hollow fibers inside or outside, depending on the chamber area to be filled.
  • This design also allows, for example, only one surface of the at least one membrane or preferably one wall (inside or outside) of the hollow fibers to be coated with the coating agent without filling the pores with the coating agent.
  • the excess coating agent can be removed from the previously filled chamber area, in particular at least initially while maintaining the filling of the other chamber area and the pores with the solvent.
  • the solvent is also displaced from the pores in a controlled manner by further filling in the coating solution and at least some of the pores are filled with the coating solution, in particular starting from the application side of the coating solution.
  • the further coating solution is poured into the chamber to be filled in a predetermined quantity, for example Chamber area refilled / pumped, whereby the solvent is then displaced from the pores, since after opening the pressure equalization to the environment is made possible and the predetermined amount fills the pores.
  • a predetermined quantity for example Chamber area refilled / pumped, whereby the solvent is then displaced from the pores, since after opening the pressure equalization to the environment is made possible and the predetermined amount fills the pores.
  • the pores can be filled very precisely, in particular only by the amount of coating solution that has been refilled.
  • the aforementioned execution of the method can be carried out particularly preferably in such a way that both fluid connections of the other chamber region not to be filled are connected to a common riser pipe or each of the fluid connections is connected to its own riser pipe and the at least one riser pipe is closed before the at least one riser pipe is closed before the initial filling with coating solution is filled with the solvent up to a reference level with respect to the surroundings.
  • the coating solution is then, as mentioned above, poured into the chamber area to be filled and the solvent is thereby displaced from the chamber area to be filled without filling the pores.
  • the other chamber area not filled with coating solution is then opened to the environment, in particular by opening the riser pipe, and coating solution is pushed into the chamber area to be filled.
  • the invention can thus preferably provide that the depth of the pore filling is adjusted as a function of the volume of the coating solution pushed in.
  • the volume that has penetrated into the pores can be measured in the at least one riser pipe in a particularly simple manner by increasing the rise height of the solvent above the previously set reference height.
  • This preferred embodiment thus allows only the surface of the at least one membrane, preferably the hollow fibers, to be coated with a skin of coating agent, but not the pores of the at least one To fill membrane / hollow fibers or alternatively to coat the surface and fill the pores. In connection with an embodiment described below, it is also possible to only fill the pores, in particular by subsequently removing the surface coating again.
  • the filling takes place with a previously degassed coating solution.
  • the coating solution can be subjected to a vacuum after the coating agent has been dissolved in a solvent or else a coating solution without further added solvent, so that any gas bubbles that may be present escape.
  • the coating solution is filled into one of the two chamber areas and the entire mass transfer device is subjected to vibration, ie is set into a vibratory movement.
  • vibration can be carried out instead of a previous vacuum degassing, but also in combination with it.
  • the gas flow influences the layer thickness/skin thickness on the membrane surface, preferably the hollow fiber wall (inside or outside, depending on the application).
  • the thickness of the gas flow and/or the duration of the action of the gas flow can thus influence the layer thickness of coating solution that remains on the membrane surface/hollow fiber wall.
  • the invention can also provide, in particular after an initial removal of excess coating solution, that the previously filled chamber area is flowed through with a solvent, in particular that with which the coating solution was also prepared. In this way it can be achieved that the skin of coating solution is completely removed from the surface of the at least one membrane/the wall of the hollow fibers and only the pore filling remains or that at least the thickness of the skin is reduced.
  • the invention can also provide for flushing the other, previously unfilled chamber area with the solvent.
  • any coating solution that may have escaped from the pores in the other chamber area can be removed in this way.
  • the coating solution is produced from a coating agent, e.g., a polymer, preferably silicone, and a solvent, e.g., n-heptane.
  • a coating agent e.g., a polymer, preferably silicone
  • a solvent e.g., n-heptane
  • n-heptane can also form the solvent for the aforementioned preferred process steps.
  • Other solvents are also suitable. Such as xylene, alkanes.
  • coating solution does not necessarily mean that a coating agent is dissolved in a solvent, although this is preferably provided. This is provided in particular when the viscosity of a coating agent, preferably a commercially available coating agent, is to be lowered with the aid of the solvent.
  • the coating solution to be formed by a coating agent comprising a polymer, preferably silicone, which is mixed with an additional solvent, in particular with n-heptane, to a viscosity less than 5000 mPas, preferably less than 3000 mPas, more preferably less than 2000 mPas.
  • the coating agent comprising polymer, in particular silicone can be one-component or multi-component, in particular two-component.
  • the coating agent in particular a commercially available one, can also already include a solvent by the manufacturer.
  • coating solution is also understood to mean a pure coating agent, in particular a commercially available coating agent, which is not diluted with an additional solvent, particularly if the viscosity is suitable for the coating even without dilution.
  • the coating agent can include a solvent by the manufacturer.
  • a coating solution according to the invention is preferably formed by a coating agent comprising a polymer, preferably silicone, which without the addition of solvents has a viscosity of less than 5000 mPas, preferably less than 3000 mPas, more preferably less than 2000 mPas.
  • the material RAU-SIK 1511 from Griffinedic or Elastosil 601 A+B, Elastosil 625 A+B from Wacker, for example, can be used as a silicone-containing coating agent.
  • These two coating compositions mentioned above by way of example are preferably diluted with a solvent, in particular n-Fleptan.
  • silicone materials are also approved as medical products and are suitable, for example, for the application according to the invention.
  • Other silicone products can also be used.
  • the ratio of silicone mass to solvent is preferably 1:4 to 1:20, in particular with regard to the respective weights.
  • the products SILPURAN 2400 A/B and SILPURAN 2420 A/B can also be used.
  • the aforementioned Elastosil RT 625 has, for example, a dynamic viscosity of 12,000 mPas and is preferably diluted with a solvent, for example n-heptane.
  • SILPURAN 2420 has a dynamic viscosity of 2500 mPas and SILPURAN 2400 has a dynamic viscosity of 1800 mPas after mixing.
  • These products can preferably be used without dilution, or with a significantly lower proportion of diluent compared to the coating materials mentioned above.
  • elastomers and/or polymers preferably silicones
  • coating materials preferably those that have different permeability coefficients for the substances to be exchanged.
  • Latex can also be used as a coating agent or coating solution.
  • the invention can also provide that, in a first method step, a coating is carried out with a first coating solution, in particular according to the embodiments according to the invention, and subsequently a coating with a second coating solution takes place, in particular according to the embodiments according to the invention, the first and second coating solutions differing from one another . It is preferably provided that the first coating solution has a higher thermal conductivity than the second coating solution, e.g. a thermal conductivity in the range of 2-2.5 W/mK.
  • the coating solution comprises at least one of the following additives: a drug, preferably an anticoagulant drug, in particular heparin, or a material for absorbing undesired gases, in particular for absorbing carbon dioxide, or a material for storing desired gases Components, in particular for storing oxygen.
  • a drug preferably an anticoagulant drug, in particular heparin
  • a material for absorbing undesired gases in particular for absorbing carbon dioxide
  • Components in particular for storing oxygen.
  • the invention preferably provides for only one of the two chamber areas to be filled with the coating solution and thus the membrane, preferably the hollow fibers, to be filled only from one side up to the pores and to coat the membrane surface/hollow fiber walls assigned to this chamber area, in particular if there is no provision for removing the skin of coating solution from the membrane surface, preferably the hollow fiber wall, as previously described.
  • the chamber area is filled with the coating solution through which the blood will later flow in a planned oxygenator application.
  • the coating solution through which the blood will later flow in a planned oxygenator application.
  • this can preferably be the chamber area that encompasses the hollow interior of the hollow fibers.
  • the outside of the hollow fiber can also be coated or, starting from this, the pores can be filled.
  • one of the two surfaces can be coated, preferably that which points into the chamber area which later carries the blood when an oxygenator is used, or else both surfaces.
  • One of the two chamber areas can be filled by various measures.
  • Each of the two chamber areas usually has two fluid connections.
  • the chamber area to be filled can be connected with both fluid connections to a pump circuit, in which the coating solution is pumped with a pump in the circuit.
  • the filling take place, for example, against the direction of gravity, in particular with the open fluid connection pointing upwards, ie forming the highest point of the system to be filled.
  • the filling can also be effected by acting centrifugal forces, e.g. by inserting a mass transfer device to be filled into a centrifuge, the coating solution being accelerated into the device through the radially inner fluid connection.
  • the invention can provide for at least one or more of the aforementioned process steps to be carried out simultaneously on a large number of mass transfer devices or product precursors.
  • the solvent is preferably provided in all cases to allow the solvent to escape from the coating solution, so that only the coating agent, preferably silicone, is left on the surface of the at least one membrane, preferably the wall of the hollow fibers and/or in the pores remains.
  • This can be supported thermally, ie by heating the treated mass transfer device.
  • the coated side can also be flushed with gas, e.g. air, in particular heated gas. Provision is preferably made to wait for the solvent to escape, while the other chamber area not filled with the coating solution is or remains closed to the environment.
  • the invention can provide that the coating agent is not only used to treat the at least one membrane, preferably the hollow fibers, as described above, but also—if the device is not subsequently flushed with solvent—to cover all surface areas of the mass transfer device or a product precursor with the coating agent, particularly in oxygenator applications to improve the hemocompatibility of the device.
  • the invention is not limited to treating dialyzers or mass transfer devices for dialysis, in particular mass transfer devices with polysulfone hollow fibers or a corresponding product precursor, in particular at least partially filling their pores and/or coating the hollow fiber walls.
  • the mass transfer devices or a precursor product may also comprise polypropylene or polymethylpentene hollow fibers.
  • mass transfer devices or product precursors can also be treated, which can already originally be used as oxygenators, e.g. to improve their properties, e.g. haemocompatibility, or to increase their area of application.
  • oxygenators e.g. to improve their properties, e.g. haemocompatibility, or to increase their area of application.
  • polymethylpentene hollow fibers have a thin, closed layer that is very unstable and can be destroyed if the hollow fibers are handled incorrectly. Coating such hollow fibers made of polymethylpentene with an additional coating agent, such as silicone, reduces the risk, or preferably eliminates it, that failure of this thin layer poses an application risk.
  • the invention can also provide for checking, in particular quantifying, the coating of the pores and/or the surface of the at least one membrane, preferably the wall (inside and/or outside) of the hollow fibers.
  • the thickness of the skin of coating agent deposited on the at least one membrane, preferably the hollow fibers, during coating is determined by determining a first pressure difference across the fluid connections of the chamber area, which the side to be coated of the at least one membrane/the hollow fibers includes at a certain fluid volume flow through this chamber area, in particular after the other chamber area, preferably also the membrane pores, has been filled with a liquid, this determination being made before the coating is carried out, and determination of a second pressure difference across the same fluid connections of the chamber area which comprises the coated side of the at least one membrane/fleece fibers at the same determined fluid volume flow through this chamber area, this determination being made after the coating has been carried out.
  • the thickness of the slack formed in the coating agent on the membrane surface can be determined as a function of the difference.
  • a dependency can be established, for example, by prior calibration, for example using a table or a functional relationship.
  • the functional relationship can be given, for example, by the Flagen-Poiseuille law.
  • the fluff level of the coating agent can be determined based on the difference in pressure differences.
  • the thickness of the coating is determined by using a first test gas with a known partial pressure of at least one gas component, in particular oxygen and /or carbon dioxide, with this test gas being passed through one of the two chamber areas, and by passing a second test gas without the aforementioned at least one gas component, in particular a second inert gas or gas mixture, through the other chamber area, and by measuring the content of the at least one gas component , in particular of oxygen and/or carbon dioxide, in particular of its partial pressure, in the second test gas after passage through the mass transfer device or through the product precursor.
  • a first test gas with a known partial pressure of at least one gas component in particular oxygen and /or carbon dioxide
  • the thickness in particular the effective thickness, can be determined depending on the measured content of the gas component and flow rates.
  • the invention can provide for determining the thickness of the coating or the sum of the coating skin and the depth of the pore filling from the measured transfer rates and the permeability constants of the coating / pore filling.
  • the skin thickness has been determined beforehand, this can be subtracted from the measured total thickness or effective thickness and the depth of the pore filling is determined in this way. If, for example, the skin was washed off beforehand, the depth of the pore filling results directly from this measuring method.
  • One embodiment can also provide for the weight of the mass transfer device or a product precursor to be recorded before and after the coating, in particular after the solvent has escaped from the coating solution, with the weight of the coating agent present in the entire coating being determined from the weight difference.
  • the weight of the coating agent deposited in the pores can then be determined from the weight of the entire coating, preferably after a previous determination of the skin thickness of the coating and the determination of the weight of the skin, e.g. based on the skin thickness, the total coated area and the specific density of the Coating agent, in particular the depth of the pore filling being determined from the weight of the coating agent deposited in the pores, preferably as a function of known pore parameters, in particular the porosity and/or number of pores and/or average pore diameter.
  • These pore parameters can come from the manufacturer of the at least one membrane, for example, or they can be measured beforehand.
  • one of the chamber areas in particular the one from whose side the coating was applied, preferably the chamber area with the hollow fiber insides in the case of hollow fibers, is pressurized and the speed of the pressure decrease is recorded.
  • the pressure drop is significantly higher than with a fault-free coated membrane/hollow-fiber package.
  • Pressure drop rate below a specific or determinable limit value can thus be used to conclude that the coating is free of defects.
  • a pressure test indicating defects can also be carried out in such a way that one of the chamber areas, e.g. the uncoated chamber area facing away from the coating side, is completely closed to the environment, e.g. with plugs or clamps on the two fluid connections.
  • the other, in particular the coated, chamber area is closed at one of the fluid connections, e.g. likewise with a clamp or plug. A pressure is applied to this chamber area via the other fluid connection and the pressure is measured in the process.
  • This chamber area in particular in the hollow fibers, is increased, which initially results in a higher pressure or higher O 2 and N 2 partial pressures in this chamber area (eg on the inside of the hollow fibers). Because of the pressure differences between the chamber areas, a pressure equalization takes place through the membranes between these chamber areas. This is evidenced by a slow decrease in pressure in the area of the chamber to which the pressure was applied. For example, once equilibrium is reached, the pressure is further increased again until a predetermined test pressure is reached, eg 500 mmHg is reached.
  • the previously pressurized chamber area, in particular the coated chamber area can now be opened to the environment, for example by removing the plug/clamp on a fluid connection.
  • the respective time delay in the pressure equalization or the pressure equalization speed can be used as a measure of the accuracy. If the speed of pressure equalization is below a predetermined limit value, or if the time delay in the pressure equalization is above a predetermined time value, it can be concluded that the coating is free of defects.
  • the invention thus offers the possibility, on the one hand, of carrying out the application of the coating agent in the pores and/or on the surface of the at least one membrane or the hollow fiber wall, in particular only on the side of one of the two chamber areas, in a more controlled manner, e.g. by reduction or Eliminating the effect of capillary forces and then also reliably checking the success of the coating.
  • a perfluoro compound in particular with fluorocarbon under a predetermined hydrostatic pressure
  • one of the chamber areas can preferably be charged with the perfluoro compound.
  • a predetermined hydrostatic pressure can be achieved, for example, by filling a chamber area connected to the area to be tested take place riser pipe. The pressure results from the filling level. The drop in level can then also be observed directly on the riser pipe if there is a leak. It is preferably provided to form coatings on the surface of the at least one membrane or on the respective walls of the hollow fibers and/or pore filling at a depth whose skin thickness and/or depths, in particular the sum of skin thickness and depth, preferably the effective effective thickness of the total coating is less than or equal to 10 microns, preferably less than or equal to 5 microns.
  • the effective coating thickness is a measure which states that the sum of the thickness of the skin layer and the depth of the filled pores acts like a pure coating of this effective thickness.
  • the sum of the thickness of the skin and the depth of the pore filling is actually somewhat larger for the membrane, because the membrane always has a porosity of less than 100%, i.e. there is always a mixture of pore material and coating material under the pure skin.
  • the process therefore makes it possible to reproducibly manufacture a medical product with consistent quality.
  • industrially previously produced dialyzers can be converted into blood oxygenators by the method according to the invention.
  • the invention therefore makes it possible, for example, to coat finished, in particular operational, mass transfer devices.
  • a product precursor of a mass transfer device in particular an element that only becomes a mass transfer device through further processing, such as the addition of further elements or the removal of parts.
  • the hollow-fiber-filled chamber area is longer in its longitudinal direction than the length of the hollow-fiber-filled chamber area of an operational and finished coated mass transfer device, which is made from this product precursor.
  • the invention can provide, in the preliminary product stage, e.g. a cylindrical housing with a hollow fiber bundle, after the hollow fibers have been potted at their end regions spaced apart in the longitudinal direction, to open the hollow fibers by cutting off the end regions, the end regions being cut off in such a way that the length of the hollow fibers is longer than the length of the hollow fibers in the chamber area of a later ready-to-use and completely coated mass transfer device.
  • the product precursor is then coated, after which the end areas are cut off again and the length of the hollow fibers is thereby shortened to the length of the hollow fibers in the chamber area of a ready-to-use and completely coated mass transfer device.
  • the mass transfer device is then formed from the preliminary product stage created in this way, e.g. by attaching cover elements to the open ends of the preliminary product stage.
  • the hollow fiber-filled chamber area of the product precursor e.g. a cylindrical housing with hollow fiber bundles
  • the product precursor is divided into several sections after coating, in particular those of an end potting of the hollow fibers, wherein a ready-to-use and completely coated mass transfer device is formed from each subsection, e.g. by the fact that cover elements are attached to the open ends of the subsections, in particular potted subsections.
  • FIG. 1 first shows a mass transfer device 1 or a preliminary product stage 1′ of a mass transfer device 1 which is to be coated according to the invention.
  • the mass transfer device 1 can be, for example, an industrially manufactured, ready-to-use dialyzer.
  • a product precursor T can, for example, be a preferably cylindrical element filled with a hollow fiber bundle of hollow fibers 2, which is designed to carry out the method with the additional features such as a mass transfer device (1), but is itself not to be regarded as a ready-to-use product since it is from the product precursor (1') only the ready-to-use device is formed.
  • a product precursor (1') and a mass transfer device (1) can thus each have the features mentioned in the claims and shown in the figures in equal measure. All features of the description of the figures and also of the general description part mentioned for a mass transfer device 1 therefore preferably also apply to a preliminary product stage T, in particular if deviations are not expressly mentioned.
  • the hollow-fiber packet comprises hollow fibers 2, preferably hydrophilic polysulfone hollow fibers 2 in the case of a dialyzer. Only a few hollow fibers 2 are shown here to simplify the drawing.
  • the mass transfer device 1 or product precursor T comprises in its housing 1a the hollow fiber bundle made up of several hollow fibers 2, which are sealed at their ends on both sides with one another and with the housing wall, which is also referred to as “potted”.
  • the chamber inside the housing 1a is divided into two chamber areas 5a, 5b.
  • the chamber areas 5a, 5b are thus separated from one another by the hollow fiber wall, which in each case forms a membrane 2a, the hollow fiber wall being permeable due to the fact that the hollow fibers are microporous.
  • the pores can, for example, have an average pore diameter of 30 to 120 nm, in particular with a porosity of the hollow fiber wall of more than 70%, preferably more than 80%.
  • the mass transfer device 1 or product precursor 1' has two fluid connections 3a, 3b which open into the first chamber area 5a and has two fluid connections 4a, 4b which open into the second chamber area 5b which surrounds the fluff fibers 2 on the outside.
  • the fluid connections 3a, 3b, 4a, 4b can be designed as sockets, in particular onto which hoses can be pushed.
  • the design is such that the first chamber area 5a borders on the fluff fibers 2 on the inside.
  • the fluid connections 3a, 3b with the first chamber area 5a form the blood side and the fluid connections 4a, 4b with the second chamber area 5b form the dialysate side.
  • the fluff fibers 2 from the inside, i.e. in the first chamber area 5a, for which purpose a coating solution made of silicone dissolved in n-Fleptan is used, e.g. fleptan.
  • Figures 2 illustrate a procedure for filling the first chamber area 5a with the coating solution by means of negative pressure, for which, according to the invention, the second chamber area 5b is closed directly at both fluid connections 4a, 4b according to Figure 2A, e.g. by plugs 4c or according to Figure 2B at both fluid connections 4a, 4b a container 6 is connected, which forms a compliance volume.
  • a pressure equalization in the chamber area 5b to the environment is prevented and desired pressure conditions in the mass transfer device or product precursor V can be set via the first chamber area 5a.
  • One of the fluid connections of the first chamber area 5a here the lower 3a, is closed, e.g. by a symbolized clamp 3c or a three-way valve, and via the other fluid connection 3b, a vacuum pump 7 in the first chamber area 5a and through the porous hollow fiber walls / Membranes 2a away also in the second chamber area 5b a negative pressure generated.
  • the device 1 is arranged such that the fluid ports 3a and 3b are spaced apart in the direction of gravity and the hollow fibers 2 extend in the same direction.
  • the coating solution 9 is sucked into the first chamber area 5a by the vacuum, preferably with the vacuum pump 7 maintaining the pressure conditions on both sides of the hollow fiber wall 2a, i.e. the pressure increase compensated by the inflowing coating solution 9.
  • a three-way valve at the fluid connection 3a to a reservoir 9a of coating solution 9 can be opened, for example.
  • the amount of coating solution 9 that has penetrated into the pores can be precisely determined on the basis of the decrease in the rising height of the coating solution 9 to a height Hi in the fluid connection 3b. In this way, the penetration depth can be determined exactly, in particular against the background of known pore volumes and/or the porosity, i.e. in particular the total pore volume of the hollow fibers 2. This decrease in the height of rise from Ho to Hi is visualized in FIG. 2D compared to FIG. 2C.
  • FIGS. 2E and 2F show the same procedure, but with the difference that the chamber area 5b at the fluid connections is not closed directly to the environment with plugs but with the container 6 mentioned in FIG. 2b, which forms a compliance volume.
  • FIG. 2G illustrates the removal of the excess coating solution 9 from the first chamber area 5a.
  • the mass transfer device 1 or product precursor V can, but does not have to, be turned around for this.
  • An air flow 10 is preferably generated through the first chamber region 5a, which removes the coating solution 9 except for a skin layer adhering to the inner wall of the hollow fiber.
  • the first chamber area 5a is then preferably treated with the same solvent 11 with which the coating solution 9 was created , here e.g. n-heptane, and thus dissolve the adhering layer.
  • the solvent 11 is pumped/pressed through the hollow fibers 2, for example, from a reservoir 11a. This is illustrated in FIG. 2H, in which the solvent 11 is shown cross-hatched. This last step is omitted if a skin layer of coating solution 9 is desired on the hollow fiber inner walls.
  • the solvent can then escape from the coating solution 9 so that only the coating agent, eg silicone, remains on and/or in the pores of the membrane 2a, as a result of which the finished coating is formed.
  • This can be supported by a heat treatment and/or an air flow 10, which is illustrated in FIG. 2I.
  • the respective lower fluid connections 3b are not shown in FIGS. 2G to 21, but are of course also present.
  • Figures 3 illustrate another preferred variant of filling the first chamber area 5a with the coating solution 9.
  • FIG. 3A first shows the mass transfer device 1 or product precursor V in unfilled form, e.g. again a dialyzer with polysulfone fibers 2, as named in FIG. 1 as an example.
  • the fluid connections 4a, 4b of the second chamber area 5b which is not intended to be filled with coating solution 9, are connected to a common riser pipe 8, for example.
  • the use of a riser 8 does not have to be provided.
  • the chamber area 5b is still open to the environment and the chamber area 5a is to be filled with coating solution.
  • both chamber areas 5a, 5b are first filled with a pure solvent 11 (again shown cross-hatched here), here again n-heptane, for example, with which the coating solution 9 is also produced .
  • the second chamber area 5b is then closed, preferably here by closing the riser pipe 8 with respect to the environment. eg with a clamp 8a.
  • the riser pipe 8 e.g. a clamp 8a.
  • all the pores in the membrane 2a/wall of the hollow fibers 2 are filled with the solvent 11, so that the pores cannot subsequently be filled with the coating solution 9 in an uncontrolled manner.
  • the coating solution 9 shown simply hatched is now pumped from a reservoir 9a through one of the fluid connections, here 3b, into the first chamber area 5a and as a result all solvent 11 is displaced from the first chamber area 5a.
  • This can be verified, for example, by the fact that the coating solution 9 emerges from the other fluid connection 3a, preferably also into a riser pipe.
  • no coating solution 9 penetrates into the pores of the membranes 2a, since the solvent 11 would have to be displaced for this, which is not possible because the second chamber region 5b is closed off from the environment.
  • the hollow fibers 2 are now filled with coating solution 9 on the inside, the pores of the membranes 2a and the chamber area 5b being filled with solvent 11 on the outside around the membranes 2a/hollow fiber walls.
  • FIG. 3D now makes it clear that the second chamber area 5b is opened to the environment again, e.g. by the riser pipe 8 being opened.
  • Coating solution 9 is now again pushed into the first chamber area 5a, in particular for which both fluid connections 3a, 3b of the first chamber area 5a are closed, so that a pressure can be built up in the first chamber area 5a and as a result the coating solution 9 penetrates into the pores and the solvent 11 ousted from these.
  • the rising height of the solvent 11 in the riser pipe 8 increases to the height Hi compared to Ho.
  • the exact amount of coating solution 9 that has penetrated into the pores of the membranes 2a or the hollow fiber walls can be read from the difference between the two heights of rise.
  • the excess coating solution 9 is then removed, for example by letting it run out and/or blowing it out, as described above for FIG. 2G.
  • a step to detach the skin layer of coating solution 9 on the inner wall of the hollow fiber can be carried out, if desired, by flushing the mass transfer device 1 with pure solvent 11, e.g. in the circuit according to Figure 3E, preferably for which the fluid connections 4a, 4b or the riser pipe 8 getting closed.
  • the mass transfer device 1 or product precursor 1' is completely coated.
  • a heat treatment or an air flow through the coated chamber area 5a can be provided in order to accelerate the escape of the solvent, preferably with the other chamber area 5a remaining closed until the solvent 11 has completely escaped.
  • the invention can preferably envisage subjecting a finished coated mass transfer device or product precursor V to a quality check, e.g. to check whether the coating has defects and/or to check what coating thicknesses were achieved during the process.
  • the thickness of a coating of the coating material e.g. silicone, deposited on the at least one membrane, in particular on the inside of the hollow fiber, can be determined.
  • the Hagen-Poiseuille law can be used to determine the pressure drop from the volumetric flow, the viscosity of a flowing medium and the inside diameter, as well as the length of a pipe through which flow occurs in a laminar steady flow of a homogeneous Newtonian fluid.
  • the inner diameter of the hollow fiber can be determined according to:
  • the invention can provide for a fluid, e.g. gas (air or oxygen, or nitrogen etc.) to flow through the chamber area before coating, to which the inner sides of the hollow fibers are assigned and thus from the measured pressure drop across the mass transfer device or product precursor V to close the native inner diameter of the uncoated hollow fibers.
  • a fluid e.g. gas (air or oxygen, or nitrogen etc.) to flow through the chamber area before coating, to which the inner sides of the hollow fibers are assigned and thus from the measured pressure drop across the mass transfer device or product precursor V to close the native inner diameter of the uncoated hollow fibers.
  • the value of the hollow fiber inner diameter provided by the manufacturer of the fibers can be used.
  • the invention provides for a fluid, e.g. gas (air or oxygen, or nitrogen etc.) to flow through the chamber area after coating, to which the inner sides of the hollow fibers are assigned and thus from the measured pressure loss across the mass transfer device or product precursor 1 ' to close the inner diameter of the coated hollow fibers.
  • a fluid e.g. gas (air or oxygen, or nitrogen etc.) to flow through the chamber area after coating, to which the inner sides of the hollow fibers are assigned and thus from the measured pressure loss across the mass transfer device or product precursor 1 ' to close the inner diameter of the coated hollow fibers.
  • the thickness of the skin deposited on the inner wall of the hollow fiber results from the difference in the inner diameter of the coated hollow fibers and the native, uncoated hollow fibers.
  • the invention can provide for carrying out a respective pressure loss measurement for different flow rates of a fluid used.
  • the invention can preferably also provide that when the pressure loss across the mass transfer device or product precursor T is measured in each case when the insides of the hollow fibers flow through the chamber area, the other chamber area adjoining the outsides of the hollow fibers preferably also does not include the pores, in particular at least those with coating agent filled pores of the hollow fibers are filled with a liquid, e.g., water, preferably, this other chamber area being closed to the environment.
  • a liquid e.g., water
  • FIG. 4A shows a measured diagram and associated evaluation for pressure loss measurements on a coated AV1000S-01 dialyzer from Fresenius.
  • the pressure loss measurements were carried out for several flows of oxygen as gas and in this example result in an average measured skin thickness of the coating on silicone of 1.2 micrometers.
  • FIG. 4B visualizes the inner diameter calculated according to Hagen-Poiseuille's law natively and coated in comparison to the manufacturer's specification, as well as the difference resulting from the different flow rates, ie the thickness of the skin on the silicone layer.
  • FIG. 5 visualizes a possible test method to be able to determine the coating thickness.
  • the coating thickness determined in this way is an effective thickness and includes the thickness of the skin on the membrane surface and the thickness or depth of the pore filling.
  • a first test gas G1 with a test gas component j eg carbon dioxide
  • a test gas component j eg carbon dioxide
  • a second test gas G2 preferably without the test gas component j
  • the other chamber region, eg 5b preferably in countercurrent, eg nitrogen is used as the test gas.
  • the test gas component j passes from the test gas G1 into the test gas G2 as a result of the gas transfer via the hollow-fiber membrane 2a.
  • the concentration of this gas component j on the outlet side of the chamber area 5a and the concentration of this gas component j on the outlet side of the chamber area 5b are measured, in particular together with the concentrations on the inlet side and the gas flow rates, and the decrease or increase in the concentration is thus determined and calculated from the known permeability coefficient of the test gas component j
  • the coating material used here eg silicone Kunststoffedic adhesive RAU-SIK 1511 and the size of the membrane surface
  • Test gas G1 contains component j
  • Test gas G2 does not contain component j.
  • CTR Q G1 E V C02>G1 ,E ⁇ QGI,A ' V C0 2,GI,A
  • CTR Q G2A V C02 ,G2,A ⁇ QG 2 ,E ' V C02 ,G2,E
  • phase 2 contains no component j:
  • the (C0 2 -) transfer rate can be determined from experimental data.
  • ⁇ Mem can then be determined from this.
  • This value of the effective thickness of the coating essentially corresponds to a depth of the pore filling if the skin was washed off according to a possible variant of the method described above. If the skin has not been washed off, the thickness of the skin, determined e.g. according to the test method mentioned above, can be subtracted from this value in order to obtain the depth of pore filling.
  • the coating thickness can also be determined by determining the weight of the coating agent deposited during coating, assuming some membrane parameters or properties, as explained below by way of example.
  • a mass transfer device comprises hollow fibers 2, the membrane wall of which has pores with a number n and an average pore diameter dp.
  • the named detour factor can be assumed to be approximately 1.
  • ⁇ M em corresponds to the diaphragm thickness.
  • the number of pores and the mean pore diameter can be estimated from the transmembrane pressure (TMP) and the membrane porosity.
  • TMP transmembrane pressure
  • TMP transmembrane pressure
  • the fluid is either a gas (e.g. O2) and/or a liquid (e.g. distilled water)
  • the transmembrane pressure is measured according to FIG. 7A preferably in the flow direction from the inside of the flohl fibers to the outside of the flohl fibers and according to FIG. 7B in the direction of flow from the outside of the flohl fibers to the inside of the flohl fibers. Basically, the measurement in only one flow direction is sufficient.
  • the transmembrane pressure is recorded by the pressure drop across the membranes of the flea fibers. After determining the transmembrane pressure: 3. Determination of the pressure loss in the chamber area to be coated (chamber area of the hollow fiber inside) as a function of the fluid flow rate
  • the chamber area that is assigned to the hollow fiber outside is isolated from the environment and water is pumped through the chamber area of the hollow fiber inside.
  • the pressure drop depending on the water flow rate is determined according to Figure 8:
  • the pressure difference is also determined as a function of the gas (e.g. O2) flow rate (gas-side pressure loss of native modules).
  • the average pore size and the number of pores can be estimated using the measurements and the above-described formula.
  • the mean pore size is about 66 nanometers and the number is about 4.9 x 10 14 .
  • the measured weight difference of the mass transfer device or product precursor V before and after the coating shows that this weight difference results from the deposited coating agent and is distributed both on the skin over the membrane surface and on the filling of the pores, especially if not the skin was washed off.
  • the thickness of the skin can be measured very precisely, particularly according to the Hagen-Poiseuille relationship. From the thickness and the coated surface, as well as the specific density of the Coating agent, the weight of the skin can be determined and deducted from the measured weight difference, so that the weight of coating agent is known, which can be attributed solely to the pore filling. Based on the determined number of pores and the average pore diameter, the depth of the pore filling in the membrane can be determined starting from the coated side, here the inside of the hollow fibers.
  • a weight difference of 10.21 grams was determined for a silicone-coated Ultraflux AV 1000S dialyzer from Fresenius Medical Care.
  • An effective thickness of the coating of approx. 7.5 micrometers can be calculated with the above data at a porosity of 80%.

Abstract

L'invention concerne un procédé de revêtement d'un dispositif de transfert de masse (1) ou son précurseur de produit (1'), dans lequel au moins une membrane (2a), de préférence une membrane poreuse (2a) est agencée dans une chambre, l'au moins une membrane (2a) divisant la chambre en une première région de chambre (5a), dans laquelle un premier côté de l'au moins une membrane (2a) peut mis en contact avec un premier milieu d'échange, et une seconde région de chambre (5b), dans laquelle un second côté de l'au moins une membrane (2a) peut être mis en contact avec un second milieu d'échange, une solution de revêtement (9) étant introduite dans l'une des deux régions de chambre (5a) et, en conséquence, le côté de l'au moins une membrane (2a) qui est associé à la région de chambre (5a) est revêtu, après quoi une solution de revêtement en excès (9) est retirée de la région de chambre (5a), l'autre région de chambre (5b) étant fermée par rapport à l'environnement extérieur avant l'introduction de la solution de revêtement (9). L'invention concerne également un oxygénateur de sang produit à partir d'un dialyseur, en particulier d'un dialyseur industriel prêt à l'emploi, selon le procédé.
PCT/EP2022/067585 2021-06-30 2022-06-27 Procédé de revêtement d'un dispositif de transfert de masse ou son précurseur de produit WO2023274967A1 (fr)

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DE102022114272A1 (de) 2022-06-07 2023-12-07 Fresenius Medical Care Deutschland Gmbh Beschichtung von Hohlfasermembranen in der Medizintechnik II
DE102022125964A1 (de) 2022-10-07 2024-04-18 Fresenius Medical Care Deutschland Gmbh Beschichtung von Hohlfasermembranen in der Medizintechnik III

Citations (5)

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JPS6264372A (ja) * 1985-09-13 1987-03-23 テルモ株式会社 膜型人工肺
US5162102A (en) * 1987-09-21 1992-11-10 Terumo Kabushiki Kaisha Medical instrument and production thereof
DE10034098A1 (de) 2000-07-13 2002-01-31 Fresenius Medical Care De Gmbh Hydrophobe mikroporöse Hohlfasermembran und Verfahren zur Herstellung dieser Membran sowie deren Verwendung in der Membranoxygenierung
EP2091633B1 (fr) * 2006-11-06 2013-01-09 NGK Insulators, Ltd. Procédé de fabrication d'une composite membrane de séparation et matériau poreux
US20180085783A1 (en) * 2016-12-04 2018-03-29 Hasan Farrokhzad Methods and systems for coating hollow fiber membrane contactors

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Publication number Priority date Publication date Assignee Title
DE102015204638A1 (de) 2015-03-13 2016-09-15 Raumedic Ag Membran für einen Oxygenator für Gausaustausch im Blutkreislauf, Oxygenator mit einer derartigen Membran sowie Verfahren zur Herstellung einer derartigen Membran

Patent Citations (5)

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Publication number Priority date Publication date Assignee Title
JPS6264372A (ja) * 1985-09-13 1987-03-23 テルモ株式会社 膜型人工肺
US5162102A (en) * 1987-09-21 1992-11-10 Terumo Kabushiki Kaisha Medical instrument and production thereof
DE10034098A1 (de) 2000-07-13 2002-01-31 Fresenius Medical Care De Gmbh Hydrophobe mikroporöse Hohlfasermembran und Verfahren zur Herstellung dieser Membran sowie deren Verwendung in der Membranoxygenierung
EP2091633B1 (fr) * 2006-11-06 2013-01-09 NGK Insulators, Ltd. Procédé de fabrication d'une composite membrane de séparation et matériau poreux
US20180085783A1 (en) * 2016-12-04 2018-03-29 Hasan Farrokhzad Methods and systems for coating hollow fiber membrane contactors

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